EDF Health

Toxic Chemicals: Regulatory exemptions prioritize industry wants over safety needs

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.
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Anti-androgenic chemicals as a class of related substances with cumulative toxicological effects

Maricel Maffini, consultant, and Tom Neltner, Chemicals Policy Director

Scientists and regulators have known for decades that certain chemicals disrupt the actions of male hormones—identified collectively as androgens—in the body. Because of their effects, these chemicals are called anti-androgens or anti-androgenic chemicals.

During gestation, fetal testes begin producing testosterone, the critical hormone required to develop reproductive organs and genitalia. Insufficient production of testosterone leads to malformation of the genital tract that may need corrective surgery in infant boys and may result in reproductive health problems later in life. Ortho-phthalates (aka phthalates), known to interfere with the production of fetal testosterone, are considered anti-androgenic chemicals.

Although phthalates are perhaps the most recognizable group of anti-androgenic chemicals in the diet, there are others, including bisphenol A (BPA), propyl paraben, and certain pesticides used in food crops. Because they cause similar harmful effects, namely adverse health outcomes for male reproductive system, their safety assessment must take into account the cumulative effects of similar substances in the diet as established by law. But what does “cumulative effect” mean? Below, we use a recent study to explain what it means, why it is important, and why FDA is failing.

Biology is not math and the concept of something from nothing Read More »

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Upcoming EDF Webinar: Register Now!

Cumulative Risk Assessment Framework: A Tool to Spur Improved TSCA Risk Evaluations

Wednesday, September 7, 2022

1:00–2:00 p.m. (ET)

Join the EDF Safer Chemicals team and our academic partners from the University of Maryland and the University of Rochester as we debut a new tool, the Cumulative Risk Assessment Framework, to support implementation of the Toxic Substances Control Act. The tool will encourage more robust evaluations of health risks from chemicals and other stressors—improving public health and increasing environmental safety.

This webinar will be of interest to those who conduct or study chemical risk evaluations/assessments, including scientists/researchers, policy makers, and policy implementers.

Registration is required.

 

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Breaking silence around Black women’s reproductive health: A conversation with Lilly Marcelin

Community activist Lilly Marcelin has dedicated her career to addressing racial and social inequities. In 2012, she founded and is now the Executive Director of the Boston-based organization, Resilient Sisterhood Project (RSP). The organization’s mission is to educate and empower women of African descent about common, but rarely discussed, diseases of the reproductive system that disproportionately affect them through workshops, trainings, empowerment circles, and community education and outreach programs. Ms. Marcelin ensures RSP’s work is done in partnership with – rather than on behalf of – Black women in order to address deeply rooted systemic racism.

I recently spoke with Lilly Marcelin to learn more about her advocacy around Black women’s reproductive health, including the importance of involving and centering Black women in this work. Read More »

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FDA acts on fluorinated plastic packaging. What are next steps?

Tom Neltner, Chemicals Policy Director and Maricel Maffini, consultant

The Food and Drug Administration (FDA) took an important step last week to protect food from PFAS contamination from plastic packaging. On August 5, the agency sent a letter to manufacturers, distributors, and users of fluorinated polyethylene food contact articles reminding them that these articles must be made under specific conditions to comply with existing regulation or otherwise the food contact articles “are not lawful.” Therefore, the food that contacted them should not be permitted for sale. The agency gave three examples of manufacturing processes that do not comply with the regulation. We flagged concerns with fluorinated plastic packaging in a July blog and applaud the agency for this action.

This significant first step needs to be followed:

  1. Investigate the companies that provided fluorinated plastic packaging for food and cosmetic uses to determine whether their products complied with the law. If not, then alert food manufacturers and retailers so they can recall the adulterated food and cosmetics.
  2. Reassess whether the process FDA approved in 1983 for fluorinating polyethylene generates PFAS and whether it should still be considered safe.

Investigate companies that provided fluorinated plastic packaging

In the letter, FDA’s Office of Food Additive Safety (OFAS) states that “available information indicates that some manufacturers of fluorinated polyethylene produce articles via alternative manufacturing methods from that stipulated in FDA’s regulation.” It identified three specific examples and says that “these alternative processes for fluorination of polyethylene are not compliant with 21 CFR § 177.1615, and are not lawful for use in food contact articles.” The three examples of unlawful manufacturing processes are:

  1. “Fluorination of polyethylene for non-food uses may occur during the fabrication or molding of the container.”
  2. “Use of fluorine gas in combination with other inert diluents such as carbon dioxide, helium, or argon.”
  3. Incorporation of oxygen into the fluorinating mixture to modify the properties of the final container.

A market search shows several brands that have in-mold fluorination of high-density polyethylene (HDPE), (here and here) and another that may use oxygen or other gases in combination with fluorine.

With the letter public, FDA’s Office of Regulatory Affairs (ORA), which handles field inspections and sampling for the agency, should ensure compliance by food manufacturers all along the supply chain. Where it finds a violation, it would manage the recall of the adulterated food.

Reassess whether the allowed use generates PFAS and should still be considered safe

About a week before FDA sent out the letter, the agency responded to our May 2021 FOIA request for the documentation that resulted in its 1983 approval of fluorinated polyethylene packaging at 21 CFR § 177.1615. The approval came in response to a 1979 food additive petition by Union Carbide.

As with most of FDA’s FOIA responses, the 233-page document has extensive redactions of health and safety information. However, two things come through clearly:

  1. Nitrogen and fluorine only: In its petition and communications with FDA, Union Carbide was inconsistent when it explained whether nitrogen was only an example of an acceptable inert gas. FDA scientists demanded clarity and the company agreed that only nitrogen would be allowed. In its recent letter, FDA reminds companies that only this condition is approved.
  2. Fluorinated organics: The petition included studies of the chemicals that migrated into a simulated food such as water or alcohol. The study evaluated the residue that remained after the food simulant was evaporated off. Union Carbide maintained that fluorine in the residue was almost entirely ionic fluorine – the kind added to toothpaste – and showed that the exposure was within tolerated levels. FDA scientists kept pushing back explaining that there was evidence the residue contained substances with a carbon-fluorine bond – a indicator of what we now refer to as PFAS. FDA finally relented, stating that “our general conclusion is that low molecular weight fluorocarbon-oxygen compounds should not be present in significant quantities.” (see page 195 of FOIA response).

We now know that levels of PFAS that were considered insignificant by FDA in the 1980s pose significant risks as evidenced by some of the agency’s recent actions. For those reasons, we reaffirm our call in our July 2021 blog and in the June 2021 citizens petition submitted by 11 organizations to FDA to reassess the safety of PFAS uses, including fluorinated polyethylene.

As part of that reassessment, FDA needs to revisit the concerns raised by the agency scientists in 1983 in light of the risks posed by PFAS. Specifically:

  • Nitrogen: In its August 5 letter, FDA states that a form of PFAS known as perfluoroalkyl carboxylic acids “can form when the fluorination of HDPE occurs in the presence of oxygen or water, but not in the presence of nitrogen.” However, the agency does not acknowledge that commercially available nitrogen contains contaminants like oxygen. Food-grade nitrogen can have as much as 10,000 parts per million (ppm) of oxygen and 55 ppm of water. These levels could well be sufficient to generate significant amounts of PFAS.
  • PFAS leaching into food: Since the amount of PFAS in food considered “significant” is dramatically lower than in 1983 when FDA made its decision, the agency needs to evaluate whether it is practical – even with the purest nitrogen – to fluorinate plastic without making PFAS.

If the agency determines that the fluorine gas treatment process creates any PFAS, the law explicitly requires that FDA evaluate safety after taking into account the cumulative effects of related substances in the diet that have related health impacts. As with virtually all of its decisions, the agency failed to do that for its 1983 approval. Given the pervasive presence of PFAS in the environment and the additional PFAS FDA authorized for use in food packaging, this type of review is even more important.

Conclusion

In summary, FDA’s August 5, 2021 letter is an important step in the effort to protect consumers from PFAS in food. Now the agency needs to investigate the companies that provided fluorinated plastic packaging for food and cosmetic uses to determine whether the products complied with the law and take action. It must also reassess the safety of the packaging even if it complies with the specific conditions in its 1983 approval.

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PART 3: Busting more industry-perpetrated myths about new chemicals and worker protection under TSCA

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

Part 1          Part 2         Part 3

I have been blogging in the last few weeks about myths the chemical industry is perpetrating about the adequacy and legality of the Environmental Protection Agency’s (EPA) recent reviews of the risks that chemicals just entering the market may present to workers.  In this post, I address another such myth that, unfortunately, EPA has swallowed hook, line, and sinker.  This myth was laid out by one of the industry witnesses at the March 13 House Energy & Commerce Committee hearing on EPA’s failures to protect workers from chemical risks.

One wonders when EPA will start doing what Congress told it to do, first in 1976 and then again, with renewed vigor in 2016:  Protect workers under TSCA – using TSCA’s authorities to meet TSCA’s health standard, not OSHA’s.

I’ll get to this third myth in a moment.  But let me first try to crystallize what is at stake in this debate.  While the Toxic Substances Control Act (TSCA) has always given EPA authority to regulate workplace risks, the 2016 amendments to TSCA strengthened EPA’s authority and mandate to protect workers.  TSCA now expressly identifies workers as a “potentially exposed or susceptible subpopulation.”  See the definition of that term in paragraph 12 here.  TSCA then requires EPA to identify and assess potential risks to such subpopulations when reviewing both new and existing chemicals.  Finally, it requires EPA to use its TSCA authorities to impose restrictions on any chemical found to present an “unreasonable risk” – which is TSCA’s health standard – to any such subpopulation.

In a word, TSCA requires EPA to protect workers under TSCA – using TSCA’s authorities to meet TSCA’s health standard, not OSHA’s.

Both before and after the 2016 TSCA amendments, the chemical industry has sought to compel or convince EPA not to regulate workplaces under TSCA, and instead to defer to OSHA.  Industry wants this because OSHA’s authority and capacity are severely limited and its legal requirements for regulating toxic substances (“health standards” in OSHA parlance) allow vastly greater risks to workers than do TSCA’s (see my previous post).

Sadly, under the Trump EPA, industry is getting its wish.  At industry’s urging, EPA is acting in a manner that is wholly contrary to TSCA – and is less health-protective than even under TSCA before the 2016 reforms.

Now let’s get back to more myth-busting.   Read More »

Also posted in EPA, Health Policy, Industry Influence, Regulation, TSCA Reform, Worker Safety / Tagged , , , | Comments are closed