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, FDA, Food, Health policy, Industry influence, Public health, 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, Developmental toxicity, Health hazards, Industry influence, Neurotoxicity, Public health, Reproductive toxicity, Rules/Regulations, TSCA / Tagged , , | Authors: / Read 1 Response

EPA’s New Chemical Regulations: Backtracking on PBTs

NOTE: This is the fifth in a series about EPA’s regulation of new chemicals. See:

What Happened?

The Environmental Protection Agency (EPA) recently proposed new regulations for its safety reviews of new chemicals under our nation’s primary chemicals law, the Toxic Substances Control Act (TSCA). One of the proposed provisions would govern which persistent, bioaccumulative,1 toxic chemicals (PBTs) should undergo a full safety review.

Why It Matters

This proposed approach would exclude certain PBTs from a full new chemical safety review. This is a concerning step backward in addressing the risks from these chemicals.

PBT chemicals do not break down readily from natural processes and raise special concern because of their ability to build up in both the environment and in people and other organisms. Even small releases of these long-lived and bioaccumulative toxic chemicals can pose long-term risks to human health and the environment. Notable PBTs—such as DDT, which affects reproduction, and methyl mercury, which is a powerful neurotoxin—impacted whole ecosystems across the United States, including the Great Lakes.

View of Lake Michigan

View of Lake Michigan Photo credit: Maria Doa

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Also posted in Adverse health effects, Chemical exposure, Health hazards, Health policy, Neurotoxicity, PBTs, Regulation, Risk assessment, Rules/Regulations, TSCA / Tagged , , , , , | Authors: / Comments are closed

EPA’s New Chemical Regulations: Industry Bias Must Be Fixed

By Maria Doa, PhD, Senior Director, Chemicals Policy, and Colin Parts, Legal Fellow

NOTE: This is the fourth in a series about EPA’s regulation of new chemicals. See Time for a New Age for New Chemicals, EPA: Now’s Your Chance to Get Foxes Out of the Henhouse, and New Chemicals Rule: EPA must require more info from industry.

A robotic-looking hand pushes down on the right side of a balance scale to unfairly influence the measurement.

What Happened?

The Environmental Protection Agency (EPA) recently proposed new regulations for its safety reviews of new chemicals under our nation’s primary chemicals law, the Toxic Substances Control Act (TSCA). One of these proposed provisions would govern how EPA can change the restricted approvals it issues for new chemicals that may pose unreasonable risks. EPA’s proposed approach would limit the type of stakeholders involved and the potential for stronger chemical regulations.

Read More »

Also posted in Conflict of interest, Industry influence, Rules/Regulations, TSCA / Tagged , , , , | Authors: / Comments are closed

New Chemicals Rule: EPA must require more info from industry

By Maria J. Doa, PhD, Senior Director, Chemicals Policy, and Greg Schweer, Consultant

NOTE: This is the third in a series about EPA’s regulation of new chemicals. See Time for a New Age for New Chemicals and EPA: Now’s Your Chance to Get Foxes Out of the Henhouse.

Chemical worker in hazmat suit and full-face respirator making new chemicals for industry.

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

Industry often waits until late in the review process to submit information—which means that EPA may spend a significant amount of time and effort to revise its risk assessments to incorporate the new information.

EPA has a major opportunity to improve the New Chemicals Program as it crafts these revised regulations. Requiring industry to provide additional “known or reasonably ascertainable information” as required by the law is an important component of this rule. This should reduce the amount of assessment “rework” the agency currently conducts.

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Also posted in Industry influence, Risk assessment / Tagged , , , | Authors: / Comments are closed

Industry is Scapegoating EPA for New Chemical Review Delays

What’s Happening?

The chemical industry has an extensive—and ongoing—history of complaining about how long it takes EPA to do new chemical safety reviews.

The irony is that industry is the very player causing the delays in EPA’s review process. Clear data indicate that chemical manufacturers are primarily responsible for the length of EPA’s reviews and the backlog of cases.

Illustration of a goat looking anxious as 6 fingers point at it from outside the frame

Why It Matters

One of EPA’s vital roles is to assess the safety of new chemicals before they enter the market.

Industry’s outcry about a backlog serves as a smokescreen to pressure EPA into swiftly approving new chemicals even when they may not be safe. This would put us all at risk, particularly those who are more susceptible or maybe more highly exposed, such as children, pregnant people, and people who live and work in fenceline communities.

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Also posted in Industry influence / Tagged , , , , | Authors: / Comments are closed