EDF Health

FDA and industry continue to ignore cumulative effects of chemicals in the diet

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 24, 2021

Tom Neltner, Chemicals Policy Director and Maricel Maffini, consultant

The Food and Drug Administration (FDA) has made no apparent progress to comply with the legal requirement that it consider the cumulative effect of chemicals in the diet that have similar health impacts when evaluating the safety of an additive. A year ago, on September 23, 2020, EDF and 11 other organizations[1] filed a formal petition with the agency documenting the problem and asking it begin complying with the law.

We reviewed FDA and industry actions since the petition was filed and found that both continued to ignore the requirement 100% of the time in:

  • Generally Recognized as Safe (GRAS) notices in which companies were required to consider the cumulative effect as part of their determination that a substance’s use was safe;
  • FDA’s responses to those GRAS notices where it found “no questions” with the flawed safety determinations; and
  • FDA’s revised guidance to industry on use of recycled plastics in food packaging.

The agency’s only response to our petition was a March 2021 letter saying it “has not reached a decision due to competing priorities” and that the “petition is currently under active evaluation by [its] staff.”

From what we can see, FDA and industry continue to make safety determinations about chemical additives without regard to their overall effect on individuals’ health and their legal obligations. Is it any surprise that consumers continue to rate chemicals in food their #1 food safety concern? Read More »

Posted in FDA, Food, GRAS, Health policy, PFAS / Tagged , , | Comments are closed

Re-visioning TSCA: Address the cumulative impacts of chemical exposures

By / Published: April 1, 2021

Richard Denison, Ph.D., is a Lead Senior Scientist.

Part 4 of a 4-part series – see Part 1, Part 2, and Part 3 here

This series of blog posts is looking ahead toward opportunities to advance a more robust and holistic vision for implementing the Toxic Substances Control Act (TSCA) as reformed in 2016.

We discussed in the preceding installments of this series the importance of ensuring that combined exposures to a chemical from multiple sources and the greater exposures and susceptibilities of certain groups are accounted for.  But it is critical to also recognize that many other factors influence the impacts chemical exposures have on our health.  This final installment in our series will discuss how TSCA can and should take into account all of these factors – that is, account for cumulative impacts.

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Posted in Health policy, Health science, TSCA reform / Tagged , | Authors: / Comments are closed

Re-visioning TSCA: Better protect those at greater risk

By / Published: March 31, 2021

Richard Denison, Ph.D., is a Lead Senior Scientist.

Part 3 of a 4-part series – see Part 1, Part 2, and Part 4 here

This series of blog posts is looking ahead toward opportunities to advance a more robust and holistic vision for implementing the Toxic Substances Control Act (TSCA) as reformed in 2016.

In the preceding installment in this series, we discussed TSCA’s mandate for EPA to conduct comprehensive chemical evaluations.  The Trump EPA’s failure to do so especially detrimental to those groups at greater risk because they are more likely to face the precise exposures and susceptibilities that the Trump EPA excluded.  In this installment of our series, we will address how TSCA can and must be used to better protect those at greater risk from chemical exposures.

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Posted in Health policy, Health science, TSCA reform / Tagged , | Authors: / Comments are closed

FDA’s Failure on Food Chemical Safety Leaves Consumers at Risk of Chronic Diseases

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 23, 2020

Tom Neltner, J.D., Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant

Update: FDA published the citizen petition upon receipt on 9/23, and is requesting public comment.

More than 60 years ago, Congress enacted legislation requiring the Food and Drug Administration (FDA) and the food industry to evaluate the cumulative effects of substances in the diet that have related health impacts when assessing the safety of chemical additives. In our decade of analyzing FDA and industry actions, we have been increasingly concerned that both have ignored this requirement. To figure it out, we investigated all safety determinations contained in Generally Recognized as Safe (GRAS) notifications voluntarily submitted by food manufacturers to FDA since the program began in 1997. We looked at GRAS notices because they are publicly available and because FDA rules explicitly require that food manufacturers include in the notice an explanation of how they considered the requirement. If there was an omission, it would be more easily noticeable.

We found that in only one of 877 GRAS notices did a food manufacturer consider the cumulative effect requirement in a meaningful way. And we found no evidence that the agency either recognized this single attempt to follow the law or had objected to the omissions in the 876 other notices. This failure has significant consequences for public health, particularly for communities who already face significant health and socio-economic disparities, and for children, who are uniquely susceptible to dietary exposures to multiple chemicals.

For this reason, EDF joined with other health, environmental, and consumer groups to file a formal petition to demand FDA and food manufacturers start following the law. The petition requests specific changes to rules designed to reinforce the existing requirement and make it easier to verify compliance. Still, given the lack of transparency in agency reviews, success still largely depends on FDA and the food industry taking seriously the mandate and the food safety implications.

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Posted in FDA, Food, GRAS, Public health / Tagged , , | Comments are closed

Round 2 on PV29 reveals even deeper flaws in EPA’s TSCA risk evaluation of the chemical

By / Published: May 20, 2019

Richard Denison, Ph.D., is a Lead Senior Scientist.

On Friday, Environmental Defense Fund (EDF) submitted a new set of extensive comments to the Environmental Protection Agency (EPA) in response to its March release of additional information on Pigment Violet 29 (PV29), the first chemical to undergo a risk evaluation under the Toxic Substances Control Act (TSCA) following the law’s amendment in 2016.

After EDF and others criticized both the dearth of health and environmental data on PV29, and EPA’s illegal withholding of those data, EPA released some additional information and opened a new comment period in mid-April.  In releasing the new information, EPA was quick to judgment, asserting that “[t]he release of these studies does not change the Agency’s proposed ‘no unreasonable risk’ determination as concluded in the draft risk evaluation published in November.”

EDF’s 100 pages of comments in Round 1 enumerated the myriad ways EPA has failed to demonstrate that PV29 does not present unreasonable risk.  Unfortunately, if anything, Round 2 has only deepened our concerns over the inadequacy of EPA’s risk evaluation.   Read More »

Posted in Health policy, Industry influence, Regulation, TSCA reform / Tagged , , , | Comments are closed

FDA seeks expert panel review of neurodevelopmental risk of inorganic arsenic in food

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: February 25, 2019

Tom Neltner, J.D., is Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant

Updated March 27, 2019 to include a link to EDF’s comments and to Project TENDR’s comments.

The United States has asked the Codex Alimentarius (Codex), the international standard setting body for food, to prioritize inorganic arsenic for evaluation of non-cancer effects such as neurodevelopmental, immunological, and cardiovascular effects. The evaluation would be conducted by an expert panel convened by the Joint Food and Agriculture Organization / World Health Organization Expert Committee on Food Additives (JECFA), on which Codex relies for scientific advice.[1]

EDF will submit comments in support of the proposal and encourages others to do the same.[2] However, FDA should not wait for the review to be finished before incorporating this evidence into its long-awaited standards for inorganic arsenic in rice.

Evidence of harm from inorganic arsenic on children’s neurodevelopment has grown more compelling

Inorganic arsenic is a known water and food contaminant. FDA has measured it in many foods included in its Total Diet Study, but it’s mostly known for its presence in baby and infant foods such as rice and fruit juices. The presence of inorganic arsenic in staples of children’s diets is concerning due to its risk of potential lasting health effects. The risks posed by inorganic arsenic on fetal and child brain development has become increasingly clear since the early 2000s as epidemiological studies began to scrutinize more subtle effects such as learning disorders and epigenetic effects. Earlier studies mostly focused on gross measures such as low body weight or increased stillbirths.

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