EDF Health

The Case of the Missing PFAS

By Lauren Ellis, MPH, Research Analyst, Environmental Health and Samantha Liskow, Lead Counsel, Health

NOTE: In a recent blog post, EDF called for EPA to revoke PFAS approved through the agency’s “low volume exemption” (an LVE is an exemption from a full safety review for new chemicals produced in quantities less than ~10 tons) and to instead require all PFAS to undergo a full safety review under the Toxic Substances Control Act (TSCA). Last month, EDF and other groups, represented by Earthjustice, formally petitioned EPA to do just that.

What Happened: We recently discovered that EPA is withholding the names of over 100 PFAS chemicals approved as LVEs—claiming that releasing that information would reveal “confidential business information” (CBI).

Why It Matters: PFAS causes harm to both the environment and to human health—including reproductive, developmental, and cancer-related effects. Given growing concerns about the risks of PFAS, the public has the right to know if they are being exposed to PFAS, especially those approved through exemptions to EPA’s new chemical safety review process.

Our Take:

  • EPA should reveal the identities of the missing PFAS LVEs. If doing so would reveal CBI, EPA should work with PFAS manufacturers to craft a name that clearly communicates PFAS class membership.
  • EPA should require full safety review for all PFAS, including those previously approved through exemptions.

GO DEEPER… Read More »

Also posted in EPA, Industry Influence, PFAS, Public Health, TSCA Reform / Read 1 Response

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

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.

Also posted in Emerging Science, EPA, PFAS / Tagged , , | Comments are closed

EPA Takes Important Step to Ban Chrysotile Asbestos

Maria Doa, Ph.D., Senior Director, Chemicals Policy

EPA has made the important and long-awaited decision to propose banning nearly all remaining uses of chrysotile asbestos in the United States. EDF submitted comments supporting this proposed ban (with some caveats) because of the high risk of cancer and fatal respiratory diseases for individuals who import, process, distribute, and use chrysotile asbestos. The rule could be significantly improved by requiring a more immediate ban. If EPA chooses a more extended phase-in of the ban, we recommend that the Agency require companies to reduce workplace exposures in the interim to better protect workers.

Summary of Key EDF Concerns and Comments

Although asbestos is a known carcinogen, it is still used in automobile brake linings, gaskets, and brake blocks, as well as in permeable separators (diaphragms) at chlor-alkali facilities to produce chlorine and caustic soda. Currently, nearly 40,000 Americans die each year from asbestos-related illnesses. These deaths are preventable and must be stopped, and we applaud EPA for taking this step toward doing so.

  • EDF supports rapid implementation of EPA’s proposed chrysotile asbestos ban. Given the unreasonable risk posed by asbestos, we call on EPA to start the ban for all uses within 6 months after publishing the finalized rule.
  • In the event EPA chooses an extended phase-in (>6 months) of the ban on using chrysotile asbestos in chlor-alkali diaphragms and sheet gaskets, it should require companies to reduce workplace exposures during the interim in a way that poses the least risk to potentially exposed populations—particularly workers. In this case, we call on EPA to require hazard communication and the hierarchy of controls—first by reducing exposure through process, engineering, or administrative changes. Personal protective equipment (PPE) as a risk-reduction measure should be used only after applying these other controls to reduce chemical exposures. However, this approach would be less effective and more burdensome on workers than eliminating exposure completely and should be used only as a short-term, interim measure until the ban goes into effect.
  • EPA should explain how its proposed disposal requirements address the unreasonable risk presented by chrysotile asbestos. EDF is concerned that EPA has not demonstrated how compliance with OSHA’s Asbestos General Industry Standard and EPA’s National Emission Standards for Hazardous Air Pollutants would eliminate unreasonable risk, as TSCA requires.
  • EPA underestimates the benefits of preventing health impacts by banning chrysotile asbestos. In baseline exposure calculations, the Agency inappropriately assumes that workers will consistently and correctly use PPE while handling chrysotile asbestos and dramatically underestimates how many individuals will benefit from the rule. EPA should bolster its Economic Analysis in the final rule to more accurately reflect the benefits of the ban.

In addition, the proposed rule indicates EPA is continuing to include troubling policy decisions in its risk evaluations. Moving forward:

  • EPA should not consider costs or other non-risk factors in risk evaluations. EPA states it will consider use of PPE and other risk-management activities in its risk evaluations to help in making risk-management decisions—an approach that is not scientifically supportable and inappropriately conflates risk assessment with risk management.
  • EPA should not inappropriately treat workers differently from the general population by applying a less-protective cancer benchmark for workers. TSCA does not support this approach. Given that workers are particularly identified in TSCA for consideration and often face higher risks than the general population, making a less-protective standard is especially unjustified. (See our June 21, 2022 blog post on this issue.)

EDF also found many areas of agreement with EPA in the proposed risk-management rule. You can read the full set of comments here.

 

 

Also posted in EPA / Tagged , | Comments are closed

Loosening industry’s grip on EPA’s new chemicals program

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

[I delivered a shorter version of these comments at the September 22, 2021 webinar titled “Hair on Fire and Yes Packages! How the Biden Administration Can Reverse the Chemical Industry’s Undue Influence,” cosponsored by Public Employees for Environmental Responsibility (PEER), NH Safe Water Alliance, and EDF.  A recording of the webinar will shortly be available here.  The webinar, second in a series, follows on EPA whistleblower disclosures first appearing in a complaint filed by PEER that are detailed in a series of articles by Sharon Lerner in The Intercept.]

The insularity of the New Chemicals Program – where staff only interact with industry and there is no real engagement with other stakeholders – spawns and perpetuates these industry-friendly and un-health-protective policies.

I have closely tracked the Environmental Protection Agency’s New Chemicals Program for many years.  Reluctantly, I have come to the conclusion that the program does not serve the agency’s mission and the public interest, but rather the interests of the chemical industry.  Despite the major reforms Congress made to the program in 2016 when it overhauled the Toxic Substances Control Act, the New Chemicals Program is so badly broken that nothing less than a total reset can fix the problems.

Revelations emerging through responses Environmental Defense Fund finally received to a FOIA request we made two years ago, and through the disclosures of courageous whistleblowers who did or still work in the New Chemicals Program, confirm what I have long suspected, looking in from the outside.  The program:

  • uses practices that allow the chemical industry to easily access and hold sway over EPA reviews and decisions on the chemicals they seek to bring to market;
  • has developed a deeply embedded culture of secrecy that blocks public scrutiny and accountability;
  • employs policies – often unwritten – that undermine Congress’ major reforms to the law and reflect only industry viewpoints; and
  • operates through a management system and managers, some still in place, that regularly prioritize industry’s demands for quick decisions that allow their new chemicals onto the market with no restrictions, over reliance on the best science and protection of public and worker health.

Many of the worst abuses coming to light took place during the Trump administration, and it is tempting to believe the change in administrations has fixed the problems.  It has not.  The damaging practices, culture, policies and management systems predate the last administration and laid the foundation for the abuses.  Highly problematic decisions continue to be made even in recent weeks.

I am encouraged by recent statements and actions of Dr. Michal Freedhoff, Assistant Administrator of the EPA office that oversees TSCA implementation.  They clearly are moves in the right direction.  But it is essential that the deep-rooted, systemic nature of the problem be forthrightly acknowledged and forcefully addressed.

Let me provide some examples of each of the problems I just noted.  Read More »

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

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.

Also posted in FDA, Food, Health Policy, PFAS, Uncategorized / Tagged , , , , | Comments are closed

State legislation requires replacement of ¼ of the country’s lead pipes

Tom Neltner, Chemicals Policy Director

With the recent passage of excellent legislation in Illinois and New Jersey, one out of every four of the nation’s lead service lines (LSLs) is on a mandatory schedule to be fully replaced, with strict limits on partial replacement in the interim. These states now join Michigan in leading the way on replacing lead pipes– made all the more important because they have some of the highest numbers of LSLs in the country.

Both the Illinois and New Jersey laws[1] were the result of extensive negotiations between stakeholders and were passed with broad bipartisan support. We applaud the bill sponsors and the advocacy organizations that made it happen.

The most significant difference between the three state policies is their deadlines for utilities to fully replace the LSLs:

  • Illinois: range of 15 years to 50 years depending on a given utility’s number of LSLs.
  • New Jersey: 10-year deadline with an option to extend to 15 years
  • Michigan: 20-year deadline.

Read More »

Also posted in Drinking Water, EPA, lead, States / Tagged , , | Comments are closed