EDF Health

Broken GRAS: Companies ignore FDA draft guidance; Bias & conflicts of interest prevail in safety determinations

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 6, 2023

By Tom Neltner, Senior Director, Safer Chemicals, Klara Matouskova, PhD, Consultant, and Maricel Maffini, PhD, Consultant

What Happened?

In our new study, we evaluated Generally Recognized As Safe (GRAS) notices—a total of 403 between 2015-2020—that food manufacturers voluntarily submitted to FDA for review. Our goal was to determine whether industry was adhering to FDA’s Guidance on Best Practices for Convening a GRAS Panel.

The guidance was designed to help companies comply with the law and avoid biases and conflicts of interest when determining whether substances added to food are safe and recognized as such by the scientific community. FDA published a draft of the guidance in 2017 and finalized it essentially unchanged in December 2022.Infographic showing how a small group of individuals populate almost half of GRAS review panels. Seven individuals accounted for 46 percent of available panel positions.

Our study found that no GRAS notices followed the draft guidance. Specifically, we also found there were high risks of bias and conflicts of interest because the companies:

  • Had a role—either directly or through a hired third party—in
    selecting panelists that likely resulted in bias and conflicts of interest.
  • Depended on a small pool of experts in which seven individuals occupied 46% of panel positions. The seven often served together, further enhancing risk of bias.
  • Relied on panels that did not realistically reflect the diverse scientific community that evaluates chemical risks to public health—which is needed to comply with the law’s requirement that there be a “general recognition” within that community that a substance is GRAS.

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Also posted in Broken GRAS, Conflict of interest, FDA, GRAS, Industry influence / Tagged , , | Authors: / Comments are closed

Broken GRAS: FDA’s lack of post-market oversight continues to create health risks

By Maricel Maffini, PhD, Consultant and Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: July 11, 2023

Brown glass vial surrounded by pepper corns

What Happened?

In April, a company called Prime Research Reports issued a press release in which it claimed FDA had approved THP (tetrahydropiperine) as a Generally Recognized As Safe (GRAS) substance “for use in food products.” There is no record that FDA has either reviewed or approved THP for use in food.

The report describes Sabinsa as a manufacturer of THP and as “a major player” in that market.[1] The substance, commercially known as Cosmoperine, is derived from a highly purified extract from black pepper; the extract, which is more than 95% piperine, is also made by Sabinsa and is marketed as BioPerine. The company describes piperine as an alkaloid present in black and long pepper.

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Also posted in Adverse health effects, Broken GRAS, FDA, GRAS, Health hazards, Industry influence, Risk assessment, Risk evaluation / Tagged , , , , , , | Authors: , / Read 1 Response

Is it time to rethink “lead-safe” and “lead-free”?

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 30, 2023

By Tom Neltner, Senior Director, Safer Chemicals Initiative, Environmental Defense Fund and Charlotte Brody, National Director, Healthy Babies Bright Futures

Key Message

The scientific consensus is that there is no known safe level of lead exposure, and that no environment or home is truly free of lead.

With a few exceptions, we think it is time to retire the terms “lead-safe” and “lead-free” from our vocabulary. It sends conflicting messages to the public, consumers, and decision-makers. And it may undermine our efforts to reduce children’s exposure to lead from any source.

Rationale

Collectively, we have dedicated over a half-century to protecting children from lead. During that time, we and other advocates have used different terms to communicate our goals. Often, we drew our terms from the federal government. For example:

  • “Lead-free” has been used by Congress since 1986 to define drinking water pipes with no more than 80,000 parts per million (ppm) of lead. It kept the term in 2014 when it changed the level from 80,000 to 2,500 ppm. Similarly, FDA issued guidance in 2010 allowing a “lead-free” label on pottery if it meets the agency’s limits on lead.
  • “Lead-safe” is in the title for HUD’s 1999 rule to reduce lead-based paint exposure in federally assisted EPA also refers to “lead-safe work practices” in its 2008 renovation, repair and painting (RRP) rule for residential property. In addition, EPA created a “lead-safe” logo in 2010 for certified RRP firms. And HUD, EPA, and CPSC use the term in their pamphlet given to millions of families renting or buying homes built before 1978.

As a result, terms like “lead-safe” and “lead-free” have been commonly used to describe community-wide initiatives, label houses on maps, describe the state of a house after remediation, and much more.

What does lead-free mean? It depends on who you’re asking and what you’re asking about. A contractor may understand the term to mean that a house meets the EPA definition of not having a lead hazard, but does the average resident understand the term the same way? Is it accurate to describe a house as lead-free if there is still lead in the drinking water? Or in the spices in the cabinets?

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Also posted in Contamination, FDA, Lead, Public health, Unleaded Juice / Tagged , , , , | Authors: / Read 2 Responses

EPA Should Use U.S. Chemical Safety Law to Turn Off PFAS Tap

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: June 30, 2023

The word

PFAS is a group of synthetic chemicals used in industrial processes and consumer products, including water-repellent clothing, such as outdoor wear, and food packaging. Once these “forever chemicals” are produced and used, they often make their way into the environment and our bodies. Many pose serious threats due to their toxic effects (often at trace levels) and their ability to build up in people, animals and the environment. Studies show that they are in almost all of us.

To make matters worse, people are exposed to multiple PFAS, not individual PFAS in isolation. Yet under the nation’s primary chemical safety law, EPA evaluates the safety of PFAS chemicals one at a time and does not consider the combined risks from exposures to multiple PFAS. Combined exposures increase the risk of harmful effects, thus magnifying the risks and the need for action.

Current Situation: All Costs, No Benefits

PFAS move easily throughout the environment and are difficult to destroy. They have contaminated drinking water, food, farms, wildlife, and the environment more broadly. At the local, state and federal levels, the U.S. is spending millions of dollars to clean up PFAS contamination. Some states, such as Michigan and Maine, are trying to recoup the costs their residents have had to bear to clean-up PFAS contamination of their water and land. The federal government is also taking action to address the widespread PFAS contamination. The costs for cleaning up PFAS contamination are imposed on society by the domestic producers, importers and users of PFAS who profit from their production and use.

Yet, despite the well-documented risks and costs to society of these chemicals, companies still continue to produce, import, and use PFAS. It is time to ban all PFAS or—if there are truly essential uses for these chemicals—limit how they are produced, imported and used so that their impact on us and the environment is minimal.

Urgent Need: Revisit, Reassess, and Regulate All PFAS

While EPA has recently tightened up approvals for new PFAS entering the market, it has yet to take significant action on those that are already on the market, which includes the hundreds of PFAS the agency approved over the past few decades. It is clear these PFAS have not been produced responsibly as demonstrated by the environmental contamination associated with many of the PFAS manufacturing facilities. And yet, many of these PFAS are still on the market. They are being produced and released into the environment, are in products we use every day, and continue to contaminate us and our environment.

Many of EPA’s approvals were made 10 to 20 years ago, before we had a full picture of the pervasiveness and degree of PFAS contamination. The data on the extent of the environmental contamination of these persistent PFAS, their ability to move through the environment, and the significant difficulty in destroying them was not as robust as it is today. Furthermore, mounting evidence shows that even trace levels of PFAS can cause developmental issues in children, reduced fertility, hormonal disruptions, and certain types of cancer.

In addition, these approvals did not consider risks to vulnerable groups, such as pregnant women and children as currently required by the law. Many communities are exposed to multiple PFAS, particularly those who live, work and play near where PFAS are made and used.

Addressing the production, import and use of PFAS would limit further pollution of our water supplies, safeguard the health of our communities, and be consistent with other strong EPA actions to address PFAS, including its recent robust proposed drinking water standards.

Effective regulation of these harmful chemicals at their source would also accelerate efforts to seek out and adopt safer alternatives. Leaving chemicals with such well-documented harms on the market makes it more difficult for innovative, safer substitutes to enter it. Failing to address these risks in effect puts a thumb on the scale in support of older harmful technologies.

Our Take

EPA should re-evaluate each of the PFAS it has approved. During that re-evaluation, EPA should use the best available science and consider the full picture of PFAS exposure. Considering each PFAS in isolation rather than the multiple PFAS people, particularly those in vulnerable groups, are exposed to will underestimate their risk.

EPA should use the Toxic Substances Control Act to take action to ban these legacy PFAS, or restrict them if the uses are truly essential, rather than continuing to allow the production, import and use of these demonstrably harmful “forever chemicals.”

Go Deeper

Learn more about EDF’s concerns about PFAS and read our follow-up blog  on how EPA can use TSCA to turn off the PFAS tap.

EPA’s information on PFAS

Also posted in Chemical exposure, Chemical regulation, Contamination, Cumulative impact, Cumulative risk assessment, Emerging testing methods, Food packaging, Health hazards, Health science, PFAS, Public health, Risk assessment, Risk evaluation, TSCA, Vulnerable populations / Tagged , , , , , , , , , , , | Authors: / Comments are closed

Representatives Call For FDA Public Hearing on Phthalates

By Joanna Slaney and Maricel Maffini, PhD, Consultant / Published: June 6, 2023

By. Joanna Slaney, Senior Director, Federal Affairs, and Maricel Maffini, PhD, Consultant

U.S. Capitol dome framed by trees

Source: A. Paige Baker, ShutterSights.com©

What Happened?

On May 19, Reps. Katie Porter, Steve Cohen, Nanette Diaz Barragán, Earl Blumenauer, and Raúl Grijalva issued a letter [PDF, 300KB] to FDA Commissioner Robert Califf calling on FDA to “act expeditiously to protect the public from the health risks posed by phthalates in food and food packaging.”

They asked the FDA to hold a public hearing on ortho-phthalates (phthalates), chemicals associated with disruptions to the development of the male reproductive system and neurodevelopment, among other health effects.

Why It Matters

In 2021, Reps. Porter and Lieu led a letter with 12 colleagues urging FDA to take action on phthalates in food and cosmetics. That letter, in part, called on FDA to take action on a 2016 petition filed by EDF and allied environmental health organizations asking FDA to revoke its approval for all uses of phthalates in food packaging and processing equipment.

In May 2022, after the petitioners sued, FDA denied the petition. The petitioners formally objected to the decision and requested a public hearing pursuant to FDA’s regulations. The agency has not provided any timeline for acting on the objections.

Request for a Public Hearing

The Representatives stated in the letter submitted last month that  FDA’s decision denying the petition was flawed. “[W]e are deeply concerned about the denial, which was made without deciding whether the remaining approved uses of phthalates in food and food packaging are safe.” (Emphasis original)

They reminded Commissioner Califf of his recent statement that chemical safety is a “really, really important area for the future – for humankind, really – and where science is evolving rapidly,” urging FDA to hold a public hearing on two areas of concern:

  • The agency’s failure to evaluate the safety of phthalates as it was legally required to do before denying the 2016 petition. The letter stated, “failing to evaluate the safety of phthalates is an abdication of the FDA’s continuing obligation to oversee the safety of the food supply.”
  • FDA’s failure to address new toxicity information that raises significant questions about the safety of phthalates. Phthalates are associated with numerous health issues, including reproductive and developmental toxicity, endocrine disruption, immune toxicity, and epigenetic alterations. The letter stated, “the denial of the petition fails to acknowledge, let alone analyze, the dozens of peer-reviewed studies that underscore the toxicity of the phthalates that remain approved for food contact use.”

Next Steps

EDF and our allies will continue to press FDA to hold a public hearing on the safety of phthalates used in food packaging and processing equipment.

Go Deeper

EDF blogs on phthalates

Also posted in Congress, Developmental toxicity, Endocrine disruptors, FDA, Food packaging, Health science, Phthalates, Public health, Public hearing, Regulation, Reproductive toxicity / Tagged , , , , , | Authors: , / Comments are closed

Unleading Baby Food: FDA’s proposed limits are a positive step, but…

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: March 1, 2023

Tom Neltner, Senior Director, Safer Chemicals

What Happened: FDA recently released draft action levels for lead in foods intended for babies and young toddlers.1 Action levels represent the point above which FDA is likely to regard food as adulterated – essentially unsafe – and seek a recall. This is a key step in implementing FDA’s Closer to Zero Action Plan.

  • Lead limits would be 10 parts per billion (ppb) for most foods.
  • Limits would be 20 ppb for dry infant cereals and single-ingredient root vegetable products, because these products may have greater lead contamination levels. (Root vegetables are primarily carrots and sweet potatoes.)

The new action levels do not apply to juices; FDA proposed limits on those in April 2022.

Why It Matters: There is no safe level of lead in the diet.

For young children living in homes without lead pipes or lead paint, diet is the primary source of their lead exposure. FDA makes clear in the proposal that:

“Even low lead exposure can harm children’s health and development, specifically the brain and nervous system. Neurological effects of lead exposure during early childhood include learning disabilities, behavior difficulties, and lowered IQ. Lead exposures also may be associated with immunological, cardiovascular, renal, and reproductive and/or developmental effects. Because lead can accumulate in the body, even low-level chronic exposure can be hazardous over time.”

Lead can enter the food chain through multiple sources, including crops grown in contaminated soil and/or irrigated with contaminated water, atmospheric deposition from industrial activities, and old food-processing equipment that contains lead. The objective is to get exposure closer to zero.

Our Take: We applaud FDA’s proposed limits, which are more protective than the European Union’s 2021 standards. BUT…on the flip side:

  • FDA failed to set action levels for popular grain-based snacks, like teething biscuits and snack puffs. The agency needs to rectify this failure with all deliberate speed.
  • More protective action levels are achievable, especially for non-rice cereals and for foods that don’t contain rice or root vegetables.
  • Proposed action levels do not apply to multiple categories of foods, including:
  • FDA’s justification for the draft action levels lacks transparency—undermining both credibility of the levels and the likelihood industry will comply with them.

In addition, USDA and industry need to expand their support for research on the methods for growing, harvesting, and processing root vegetables, rice, and quinoa to further reduce lead contamination in these important foods. Research should include both store-bought and homemade baby foods.

Go Deeper: Visit our new Deep Dives blog to see our 3-part series, which provides a more detailed analysis of FDA’s proposal—including our recommendations for setting more protective limits and improving the transparency and credibility of the agency’s process of setting action levels.

NOTES
1 FDA’s guidance refers to babies and young children. Younger than two is a very narrow definition of young children, especially since children up to age six are particularly vulnerable to the harm that lead causes to their brains. Other federal agencies set standards for this broader age range. Toddlers are generally considered to be between 1 and 3 years of age. Therefore, we use the term “young toddlers” to avoid confusion.

Revised on March 21 to correct quote.

Also posted in Deep Dives, FDA, Health policy, Health science, Public health, Unleaded Juice / Read 1 Response