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Whistleblower revelations about EPA TSCA new chemical reviews

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

[I delivered these comments at the July 28, 2021 webinar titled “Toxic Chemicals, Whistleblowers, and the Need for Reform at EPA
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red by Public Employees for Environmental Responsibility (PEER), NY PIRG, and EDF.  [A recording of the webinar is available here.]  The webinar followed on whistleblower disclosures in a complaint filed by PEER and the first in what will be a series of articles by Sharon Lerner in The Intercept detailing the allegations.]

I have long described the EPA new chemicals program as a “black box.”  For decades, it has operated almost entirely out of public view, in multiple respects:

  • Excessive confidentiality claims and withholding of information from the public have been standard operating procedures.
  • A purely bilateral mode of operating developed, where the only parties in the room are EPA and the chemical industry.
  • The inability of the public to access information and meaningfully participate has severely limited public input and scrutiny.
  • As a result, a highly insular, almost secretive program culture arose over time, one where EPA has often viewed its only stakeholders to be the companies seeking quick approval of their new chemicals.
  • In sum, private interests trumped public interests.

TSCA reform sought to address key problems

The 2016 amendments to TSCA significantly overhauled the new chemicals provisions of the then-40-year-old law, seeking to rebalance those interests to some extent:

  • EPA for the first time is required to make a safety finding for each new chemical and explain the scientific basis for its finding.
  • Lack of sufficient information in and of itself is grounds for restricting a chemical and/or requiring testing. Before, unless EPA had enough data to show potential risk, it simply dropped the chemical from further review and allowed it onto the market.
  • Companies’ ability to simply assert their submissions are confidential has been reined in in several ways.

To be sure, the amendments did not address all of the program’s problems.  For example, despite the fact that the vast majority of new chemicals lack basic safety data, requiring companies to provide a minimum set of information – as many other countries do for new chemicals – was a bridge too far in the face of massive industry opposition.  The revelations indicate this is still a big problem:  Despite TSCA’s mandate that EPA restrict or require testing of chemicals lacking sufficient information, that has not been happening.  EPA still excessively relies on estimating a new chemical’s potential risks using models and extrapolations of data from other chemicals – approaches that have serious limitations, introduce large uncertainties, and are themselves a black box.

Enter the Trump EPA – the damage done

Immediately after the 2016 reforms, there were signs that EPA was starting down a better path.  But under the last Administration that progress was quickly reversed and the worst features of the pre-reform program came roaring back.  Indeed, where the program ended up was worse than before TSCA reform.  Clearly, the new revelations vividly show that – and how far we have to go, both in implementing the reforms and in changing the disturbing culture that still pervades the program.  What strikes me about the whistleblowers’ allegations is that they all cut in industry’s favor, removing or downplaying risks the scientists had flagged.  This argues against these simply being cases of scientific disagreement and points to a systemic problem.  Read More »

Also posted in Industry Influence, TSCA Reform, Worker Safety / Tagged , , | 3 Responses

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, Regulation, States / Tagged , , | Comments are closed

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

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.

Read More »

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

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

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.

Read More »

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Getting chemical safety back on track 5 years after TSCA reform

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.

Read More »

Also posted in EPA, Public Health, Regulation, TSCA Reform / Tagged | Comments are closed

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

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.

Also posted in EPA, lead, Public Health / Tagged , , , | Comments are closed