EDF Health

Selected tag(s): Risk evaluation

New guidelines to inform EPA’s approach to cumulative risk

By EDF Blogs / Published: September 12, 2023

Paige Varner, PhD, Scientist, Healthy Communities

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 »

Posted in Chemical exposure, Cumulative impact, Cumulative risk assessment, Health policy, Public health, TSCA, Vulnerable populations / Also tagged , | Authors: / Leave a comment

FDA says “Cookware that exhibits any level of leachable lead upon testing is prohibited.”

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 15, 2023

What’s New?

For the first time, FDA has provided guidance on how to evaluate whether metal cookware is prohibited due to lead leaching into food.

As part of an investigation to find the source of elevated blood lead levels in some refugee children, the Hazardous Waste Management Program in King County, Washington [1] encountered high lead levels in certain imported [2] aluminum cookware, including pressure cookers and pots & pans. The program attempted to bring this to FDA’s attention in late 2019, and submitted a formal product report to FDA in October 2021, after several attempts to contact an FDA representative directly.

In May 2022, the Program published a journal article about its findings; a year later, staff emailed FDA again seeking guidance. On June 1, 2023, FDA responded with a letter [PDF, 166KB] providing a method (see below) to evaluate lead in metal cookware. The agency also said:

  • “The marketing in interstate commerce, including importation, of cookware that exhibits any level of leachable lead upon testing is prohibited.”
  • “Neither lead nor lead-containing materials (e.g., metals, solder) are permitted under FDA regulations for use in contact with food.”
  • The Program should “feel free to share this letter or any of its contents with Amazon.com, Inc.,[3] and any other firms involved in the marketing or sale of cookware.”[4]

Why It Matters

Read More »

Posted in FDA, Health hazards, Lead, Risk evaluation, Vulnerable populations / Also 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

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.

Why It Matters

First, the statement is at odds with the available evidence: there is no record of FDA reviewing the safety of THP as a GRAS substance. The only interaction we are aware of was in 2013, when Sabinsa voluntarily asked FDA to review its GRAS determination for BioPerine to be used as a flavoring agent. A few months later, Sabinsa sent a letter asking FDA to stop reviewing the safety assessment (also known as a “cease to evaluate” request). After that, there does not appear to have been any interactions between Sabinsa and FDA regarding either of its products.

Second, the statement mistakenly claims that FDA approves GRAS substances when in fact the agency issues an opinion when a manufacturer requests a review by FDA. In its opinion letters, the agency makes clear that it is not an approval.

Third, a decade ago, we identified significant safety concerns with BioPerine, the only product that FDA has had an opportunity to review although, as previously noted, that review was halted when Sabinsa withdrew its request for review. As a result, FDA did not issue an opinion. In 2013, the authors, on behalf of the Natural Resources Defense Council at the time, sent a letter to FDA listing many issues with the GRAS notice that Sabinsa had withdrawn, including:

  • Lack of toxicology testing for the extract, which is more than 95% piperine, the active ingredient.
  • Failure to correctly interpret toxicity data in the literature, which showed that piperine is toxic to the immune system and causes reproductive and developmental toxicity in animals and cell-based studies.
  • Dismissal of human studies showing that piperine affects the metabolism of other compounds including medications by increasing their bioavailability.

Piperine is “reported to enhance the bioavailability of drugs, nutrients, and herbal extracts,” and Cosmoperine is marketed as a “bioavailability enhancer.”

The presence of these substances in food could potentially increase the bioavailability of medications in ways that healthcare professionals prescribing the drug could not anticipate. As a result, the drug might have adverse health effects from the higher effective dose.

Our Take

It is clear that BioPerine and the related Cosmoperine are highly concentrated extracts from black pepper that have been neither adequately tested nor adequately evaluated to determine their uses are safe.

We have published multiple articles describing the problems with the GRAS process. Among the most egregious of FDA’s failures are:

  • Allowing companies to withdraw a GRAS notice where the company realizes that FDA may not give it a favorable review;
  • Not proactively making the concerns publicly available[2] about the safe use of the substance;
  • Not conducting any apparent post-market oversight when FDA has concerns about the safety of a chemical.

In our Broken GRAS series we show many examples of chemicals of dubious safety that stealthily entered the food supply without any warnings.

In January, FDA Commissioner Califf announced a “new and transformative vision for the FDA Human Food Programs” These are important steps, but a real measure is ensuring that GRAS substances where FDA had safety concerns are subjected to strong oversight to protect American’s health by restricting the use of harmful chemicals such as THP.

Next Steps

We have alerted FDA to the claims and asked the agency to quickly investigate this product and its uses to protect consumers–especially those who might be using one of the medications that are affected by THP. FDA responded that it “will take a closer look and make sure this information is routed as appropriate.” We will continue to press FDA to act expeditiously to get products like this one off the market until the agency can verify its safety.

[1] We don’t know the relationship between Prime Research Reports and Sabinsa and have not heard back on a request for information.

[2] The information may be available through a Freedom of Information Act but that does not mean it is publicly available since only the requester gets the information.

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

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

Faucet with liquid pouring out next to the word PFAS under a magnifying glass

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

EPA’s information on PFAS

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

Toxic Chemicals: Regulatory exemptions prioritize industry wants over safety needs

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: December 2, 2022

A rubber stamp lies on its side to the right of the photo. To the left, you see the stamped image of a skull and crossbones and the words Toxic Substances

By Maria Doa, PhD, Senior Director, Chemicals Policy

What’s the Issue?

EPA grants exemptions from full safety reviews for approximately half the new chemicals submitted by the chemical industry. Once those exemptions are granted, EPA very rarely revises or revokes them—even in the face of new information.

The Toxic Substances Control Act allows EPA to grant an exemption from a full safety review only if it determines that the chemical will not present an unreasonable risk. That’s a high standard—and one that many exemptions do not meet.

Why it Matters:

  • The chemical industry takes maximum advantage of exemptions given the abbreviated safety review and the industry’s ability to keep their use of new chemicals under the radar. For example, the chemicals that get exemptions don’t go on the national inventory of chemicals that are in use.
  • For years, EPA has granted exemptions for chemicals that can have long-term negative impacts on human health and the environment. They include hundreds of exemptions for PFAS, “forever chemicals” known to contaminate our water supplies and farmland. And it’s not just PFAS. EPA has granted exemptions for other types of persistent, bio-accumulative, toxic (PBT) chemicals that can have lasting impacts on people and the environment.
  • These exemptions often contradict TSCA’s requirement that EPA consider the risks from a chemical throughout its lifecycle. That includes the risks for vulnerable groups who may be more susceptible to the chemical or who are more highly exposed, such as frontline communities.
  • EPA does not typically consider the cumulative impacts of multiple exempted chemicals on frontline communities, consumers, or the environment.

Our Take: EPA has an important opportunity to address overuse of TSCA exemptions.

Next Steps:

  • EPA should revisit the exemptions it has already granted. The agency should determine that chemicals truly do not present an unreasonable risk—particularly to vulnerable populations—throughout their lifecycles. EPA should focus first on chemicals that can have long-lasting impacts on health and the environment, like PFAS and other PBTs.
  • Before granting any new exemptions, EPA should consider the combined impacts throughout the lifecycle of these chemicals on all stakeholders, especially frontline communities. EPA Administrator Regan recently said EPA would be embedding environmental justice into the DNA of EPA. This is another opportunity for EPA to do just that.
Posted in Frontline communities, Industry influence, Public health, TSCA / Also tagged , , , , , , | Authors: / Comments are closed

Sperm Concerns: Sons Affected by Mom’s Exposure to Forever Chemicals

By Lauren Ellis / Published: October 19, 2022

Illustration of gray sperm swimming toward a dark purple egg on a light purple background

By Lauren Ellis, MPH, Research Analyst, Safer Chemicals

What’s New: A peer-reviewed study by Danish researchers found that a male fetus who is exposed to PFAS (per- and polyfluoroalkyl substances—also known as “forever chemicals”) during early pregnancy is more likely to have lower sperm quality in early adulthood.

It’s the first study to explore the impact of exposure to more than two PFAS compounds (as measured in maternal blood samples during early pregnancy) on adult male reproductive hormones and sperm quality.

Why It Matters: Poor sperm quality is directly related to male infertility. In addition, it has been linked to other health problems such as testicular cancer, heart disease, and all-cause mortality.

This study adds to decades of literature linking environmental chemical exposures to negative impacts on reproductive health.

Key Lessons from the Study:

  • Women who were pregnant 20+ years ago had multiple types of PFAS in their blood. The study used data on a group of Danish women who were pregnant between 1998-2003. The women gave blood samples, which were then frozen and stored; 95% of those samples were taken in the first trimester of pregnancy.
  • In 2020-2021, researchers tested those maternal samples for 15 different PFAS compounds. They found 7 of the 15 in the bloodstream of nearly 90% of mothers in the study. The seven were: PFHxS, PFHpA, PFOA, PFOS, PFNA, PFDA, and PFUnDA.
  • Exposure to PFAS during pregnancy decreases the sperm quality of adult male offspring. Researchers found that both combined and single exposure to maternal PFAS concentrations during early pregnancy had a negative effect on the sperm quality—particularly sperm count, concentration, and movement—of adult male offspring.

Our Takeaway: The new study presents a startling finding—developmental exposures to chemicals are associated with long lasting harm, including impacts that can affect future generations. It also adds to the growing evidence of PFAS health risks and demonstrates the urgent need for more health-protective PFAS policies and regulations.

Next Steps: EDF and our partners are pushing EPA to revoke existing PFAS exemptions and require those PFAS (and new PFAS coming to market) to undergo a full safety review under the Toxic Substances Control Act, our nation’s primary chemical safety law.

It is critical that these evaluations also consider the cumulative risk of exposure to PFAS mixtures in the environment.

Note: In June 2021, EDF, with a group of health, environmental, and consumer organizations, sent a formal petition to FDA asking the agency to ban all PFAS  that accumulate in the body. That petition is still under review.

Posted in Emerging science, Regulation / Also tagged , , | Comments are closed