EDF Health

Finally—EPA takes steps to unify its approach to the evaluation of chemicals for cancer and non-cancer endpoints

By Jennifer McPartland / Published: July 13, 2021

Jennifer McPartland, Ph.D., is a Senior Scientist, and Lariah Edwards, Ph.D., is an EDF-George Washington University Postdoctoral Fellow

A recent article in Inside EPA ($) indicated that the US EPA’s Integrated Risk Information System (IRIS) will begin piloting a “unified approach” to the evaluation of chemicals for cancer and non-cancer endpoints. Specifically, it appears that the program intends to develop analyses demonstrating how a unified approach could work as supplements to some of its chemical assessments. This represents a major step forward in advancing the science of chemical assessment at EPA and is responsive to recommendations the scientific community and stakeholders have been making for years.

By way of background, chemical regulatory assessments generally assume that if a chemical is a genotoxic carcinogen, there is no exposure threshold for the effect. This means that across a diverse population, some level of risk for developing cancer exists at any level of exposure. Traditionally for all other toxicity endpoints, EPA and other regulatory agencies typically have assumed that there is a bright-line exposure threshold below which no adverse health effect will be seen.

This bifurcated approach to characterizing chemical hazards and risks is not scientifically supported. The assumption that there are “safe” exposure thresholds for all non-cancer endpoints ignores real-world variability in exposure and susceptibility across the human population.  This variability influences whether any particular person or group will experience an adverse effect, and includes such factors as: co-exposures to other chemical and non-chemical stressors and differences in susceptibility that may arise from things like genetic differences or underlying health conditions.

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Beyond paper: PFAS linked to common plastic packaging used for food, cosmetics, and much more

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: July 7, 2021

Tom Neltner, Chemicals Policy Director, Maricel Maffini, consultant, and Tom Bruton with Green Science Policy Institute. 

Update August 11, 21 – Added FDA’s Response to FOIA.

Results from an Environmental Protection Agency (EPA) investigation into PFAS-contaminated pesticides have much broader, concerning implications for food, cosmetics, shampoos, household cleaning products, and other consumer products, as well as recycling. This investigation, first announced earlier this year, found that fluorinated high-density polyethylene (HDPE) containers used for pesticide storage contained a mix of short and long-chain per- and polyfluorinated alkyl substances (PFAS), including PFOA, that leached into the product. From what EPA can tell, the PFAS were not intentionally added to the HDPE containers but are hypothesized to have been produced when fluorine gas was applied to the plastic.

Since EPA released its investigation, we have learned the disturbing fact that the fluorination of plastic is commonly used to treat hundreds of millions of polyethylene and polypropylene containers each year ranging from packaged food and consumer products that individuals buy to larger containers used by retailers such as restaurants to even larger drums used by manufacturers to store and transport fluids.

The process of polyethylene fluorination was approved by the Food and Drug Administration (FDA) in 1983 for food packaging to reduce oxygen and moisture migration through the plastic that would cause foods to spoil. The fluorination process forms a barrier on the plastic’s surface and it also strengthens the packaging.

Fluorination of plastic leading to the inadvertent creation of PFAS may be another reason these ‘forever chemicals’ show up in many unexpected places. This significant source of PFAS contamination needs to be addressed. Much remains to be resolved as FDA and EPA actively investigate this new source of PFAS; however, preventive steps need to be taken quickly, especially since other PFAS-free barrier materials are available as alternatives.

Growing evidence links PFAS to a wide range of serious health effects – from developmental problems to cancer.

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Heart disease and adult lead exposure – the evidence grows more compelling

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 30, 2021

Tom Neltner, J.D., is Chemicals Policy Director

Two recent articles add to the already strong evidence that adult exposure to relatively low levels of lead is associated with heart disease, the leading cause of death in the United States, after COVID-19. These studies reinforce the urgent need to reduce not only children’s exposure to lead but also adult exposure through regulatory action.

A February 2021 Environmental Health Perspectives article found that blood lead levels were positively associated with prevalence of moderate to severe coronary artery stenosis (CAS), the narrowing of at least 25% of these vital arteries to the heart. The researchers studied a cohort of 2,000 Korean adults studied with no history of CAS, cardiovascular disease (CVD), or occupational exposure to lead. The vast majority of their blood lead levels were below the U.S. Center of Disease Control’s (CDC) reference level.[1] The researchers found that he severity of CAS is an important predictor for life threatening cardiovascular disease, even after adjusting for factors such as age, sex, hypertension, body mass index, regular exercise, smoking, and alcohol drinking.[2]

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Getting chemical safety back on track 5 years after TSCA reform

By EDF Blogs / Published: June 22, 2021

Five years ago, President Obama signed into law the Lautenberg Chemical Safety for the 21st Century Act, which overhauled the country’s chemical safety law to better protect people from toxic chemicals.

In a welcome change to the dismal Toxic Substances Control Act (TSCA) reform anniversaries during the Trump administration, this year we are able to highlight some signs of progress we have seen from the Biden EPA that are getting chemical safety back on track.

Though significant challenges remain and lots of work lies ahead to repair the damage done by the former administration and advance a broader vision of health protection for everyone, here are five ways the Biden administration has started to turn things around on chemical safety:

1. Naming leaders committed to scientific integrity and public health protection

With Michael Regan at the helm of EPA, the agency is already miles ahead of where it stood in the last administration. The critical position for overseeing TSCA implementation at EPA is the leader of the Office of Chemical Safety and Pollution Prevention. Fortunately, a chemist with deep experience on TSCA and other chemical issues from her time on Capitol Hill, Dr. Michal Freedhoff, has been confirmed for the role.

Both Regan and Freedhoff have made strong statements supporting a return to scientific integrity and transparency – which are critical needs to building back trust. Dr. Freedhoff specifically cited how the Trump White House forced EPA scientists to weaken their assessment of the dangerous chemical trichloroethylene, an egregious example of political interference in science-based decision-making.

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FDA’s short-sighted approach to building trust in the safety of cell-cultured meat and seafood products

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 17, 2021

Tom Neltner, J.D., is Chemicals Policy Director

Consumer trust that products are safe to eat is essential to acceptance of any innovative food product.

One of the most innovative food products expected to enter U.S. markets in coming years is cell-cultured meat and seafood. Producing these products by culturing cells in tanks and forming them into foods that look and taste like their conventionally produced counterparts is a technological achievement. Proponents enthusiastically tout these products as climate-friendly alternatives that provide real hope to meet the world’s growing demand for animal protein in a sustainable way that also minimizes animal welfare concerns.

Consumer trust that products are safe to eat is essential to acceptance of any innovative food product. That trust is built through a rigorous, transparent, and independent scientific review to ensure safety. Without that, questions linger that undermine widespread consumer adoption.

Unfortunately, we have serious concerns that the process the Food and Drug Administration (FDA) may be planning to use to review the safety of cell-cultured meat and seafood is inadequate and will undermine consumer trust. From our perspective, the manufacturing process for cell-cultured meat and seafood is a significant departure from current practice and warrants careful scrutiny. FDA guidance is clear that, for these types of changes, the appropriate review options are a food additive petitions or the voluntary Generally Recognized as Safe (GRAS) notification process. We strongly recommend FDA rely on these existing options existing options rather than create a new approach.

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Momentum is building to fund lead pipe replacement across the country: New video

By Joanna Slaney / Published: June 10, 2021

Joanna Slaney, Legislative Director and Sam Lovell, Communications Manager. 

As Congress pursues infrastructure legislation, it’s clear that replacing lead pipes is a priority issue. This is welcome news for our health, the country’s infrastructure, and the economy. We are glad to see the attention on this issue from Congress and from the Administration with the inclusion of funding to fully replace lead pipes in the President’s American Jobs Plan.

And it’s no wonder there is growing interest in this initiative, the latest polling from the Navigator shows support for funding lead pipe replacement at 83% nationally – including 73% of Republicans, 80% of Independents, and 91% of Democrats. This echoes earlier polls which have found similar overwhelming bipartisan support. 

As EDF has written before, a $45 billion investment in lead pipe replacement over ten years would:

  • Protect public health by enabling water systems around the country to quickly begin eliminating the LSLs to protect residents.
  • More than pay for itself. Fully replacing lead service lines across the country would yield more than $205 billion in societal benefits over 35 years — a 450% return on the investment – due to prevented heart disease deaths from adult lead exposure.
  • Permanently upgrade infrastructure by facilitating critical upgrades to water distribution systems in a way that protects residents from increased lead in their drinking water when the LSL is disturbed.
  • Reduce disparities by enabling utilities to fully replace LSLs, thereby resolving equity concerns that utilities currently face in replacing the lead pipe on private property.
  • Create jobs for the plumbers and contractors who will perform the LSL replacements. This is shovel-ready work that involves construction and plumbing crews conducting the replacement.

With bills in both the House and the Senate focusing on funding lead pipe replacement, it’s important we keep pushing to ensure the federal government follows through on getting the lead out of our drinking water. 

See EDF’s new video that explains why lead service line replacement is important, and why it’s a no-brainer for the federal government to invest in.

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