Monthly Archives: September 2021

Not goodbye, but see you later

By Richard Denison / Published: September 29, 2021

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

After nearly 35 years at EDF, I am retiring this week.

While I have had the privilege of working on many things in my time at EDF, for the last 20+ years my main focus has been on the Toxic Substances Control Act: making the case for why reform was so badly needed; helping shape what that reform should look like; traversing every twist and turn on the long and winding road to get the Lautenberg Act finally enacted; and providing EPA with our advice on how to get strong and lawful implementation of the law off the ground.

I don’t know that any of us who worked so hard on all of the above imagined what a tragic turn all of that work would take with the arrival of the Trump administration.  They simply handed over the keys to the chemical industry and its bevy of law firms, trade associations, and consultants, who quickly shattered the fragile consensus and good will that had allowed the reform to happen, and then systematically undermined the intent of the law in a manner that actually made many things worse than before.  EDF’s and my role necessarily shifted to one of vociferous opposition, documenting and challenging how EPA political appointees were thwarting the law, science, and the agency’s mission to protect health and the environment, including those at greatest risk.

Considerable damage was done to EPA, including to its most valuable resource, the career staff.  Considerable time will be needed to right the ship.  I am hopeful about the corrective actions that have already been taken by new EPA leadership and what they are signaling is still to come.

It is vital not only that the damage be fixed, but also that EPA work to realize a broader vision for what TSCA can be and must do to fully account for and protect those most exposed or susceptible to chemical risks – including fenceline communities, workers, and children.  Earlier this year we published a series of posts to this blog titled “Re-visioning TSCA” that lays out some of our thinking about why and how this work should begin immediately.

Enormous tasks lie ahead.  EDF has had and will continue to have a strong team working on TSCA, and we will shortly be announcing a new member who will lead this work.

I plan to take a break and return at a later point to continue to advise our team on this important work.

Finally, a note about the EDF Health blog:  Our program started it in February 2008 to be able to weigh in and talk about our work back then to ensure the safety of nanomaterials.  Some 820 posts later, we now regularly address a range of issues we work on relating to chemicals and health.  We also strive to do more than just opine on the issues – often using the blog to present the results of our research and analysis of problems and detailed recommendations for how they should be tackled.

I was startled to see that, over these years, I have contributed about 475 posts, more than 350 of them directly focused on TSCA.  That is a lot of words, but I hope they can still serve as a resource, and a window into what we believe can and needs to be done to protect everyone from toxic chemicals.

For now, I’ll just say, not goodbye, but see you later.

Posted in Health policy, Public health, TSCA reform, Worker safety / Tagged | Read 5 Responses

Broken GRAS: Undermining the safety of dietary supplements and food

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 27, 2021

Tom Neltner, Chemicals Policy Director and Maricel Maffini, consultant

Over the years, we have seen a disturbing approach being taken by some dietary supplement companies to circumvent the Food and Drug Administration’s (FDA) oversight. Their strategy undermines both dietary supplement safety and food safety. These companies are leveraging FDA’s decision to allow manufacturers to secretly self-certify food chemicals as Generally Recognized as Safe (GRAS) in order to:

  1. Bypass mandatory new dietary supplement ingredient (NDI) notice requirements; and
  2. Expand their market from dietary supplements into conventional food.

We have long-challenged FDA’s interpretation of the GRAS exemption in the Food Additives Amendment of 1958 because it results in the agency being unable to fulfill its statutory duty to ensure food is safe.[1] When Congress passed the amendment, the GRAS exemption was expected to be for common substances like oils and vinegar. In this blog, we explain how the agency’s flawed approach to GRAS also undermines the safety of dietary supplements. Read More »

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FDA and industry continue to ignore cumulative effects of chemicals in the diet

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 24, 2021

Tom Neltner, Chemicals Policy Director and Maricel Maffini, consultant

The Food and Drug Administration (FDA) has made no apparent progress to comply with the legal requirement that it consider the cumulative effect of chemicals in the diet that have similar health impacts when evaluating the safety of an additive. A year ago, on September 23, 2020, EDF and 11 other organizations[1] filed a formal petition with the agency documenting the problem and asking it begin complying with the law.

We reviewed FDA and industry actions since the petition was filed and found that both continued to ignore the requirement 100% of the time in:

  • Generally Recognized as Safe (GRAS) notices in which companies were required to consider the cumulative effect as part of their determination that a substance’s use was safe;
  • FDA’s responses to those GRAS notices where it found “no questions” with the flawed safety determinations; and
  • FDA’s revised guidance to industry on use of recycled plastics in food packaging.

The agency’s only response to our petition was a March 2021 letter saying it “has not reached a decision due to competing priorities” and that the “petition is currently under active evaluation by [its] staff.”

From what we can see, FDA and industry continue to make safety determinations about chemical additives without regard to their overall effect on individuals’ health and their legal obligations. Is it any surprise that consumers continue to rate chemicals in food their #1 food safety concern? Read More »

Posted in FDA, Food, GRAS, Health policy, PFAS / Tagged , , | Comments are closed

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

By Richard Denison / Published: September 22, 2021

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 »

Posted in Health policy, Health science, Industry influence, PFAS, Public health, Regulation, TSCA reform, Worker safety / Tagged , , | Authors: / Comments are closed

Chemicals in food continue to be a top food safety concern among consumers

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 16, 2021

Chemicals in food continue to be a top food safety concern among consumers

Tom Neltner, Chemicals Policy Director and Maricel Maffini, consultant

The latest annual food industry survey demonstrates that U.S. consumers continue to have significant concerns about chemicals in food. Specifically, the survey from the International Food Information Council (IFIC) found:

  • 29% of consumers rated chemicals in food as their top food safety concern, more than any other issue, including foodborne illness from bacteria. Everyone rated chemicals in food among the top three concerns. Chemicals in food has been the top concern every year since 2017, tying risk from COVID-19 from food last year. It has been a significant concern back to the first IFIC Food and Health Survey in 2009.
  • 69% of consumers did not realize that the U.S. government is responsible for reviewing the safety of low-calorie sweeteners, which are among the most well-known food additives.
  • 54% of consumers reported it is important that ingredients do not have “chemical-sounding names” including 26% that rate it “very important.” Their opinion is primarily based on food safety and healthfulness concerns.

Our takeaway is that consumers continue to be concerned about chemicals in food, partly because they are not confident that the federal government is actually ensuring additives are safe. Therefore, they do their best to try and protect their health and safety by avoiding ingredients that sound like chemicals – the only way they see to control the perceived risk. In reaction to consumer concerns, food companies have undertaken “clean label” programs that either remove these ingredients (which can be helpful) or use names that do not sound like chemicals (which obscure the fact and can be misleading).

A better approach is to actually ensure the chemicals in food are safe and healthy rather than leaving consumers to judge products based on the sound of the ingredient names. Actual safety is the outcome that Congress intended when it adopted the Food Additives Amendment of 1958. Instead, the Food and Drug Administration (FDA), the agency with both the responsibility and the authority for food safety, allows companies to decide in secret that additives are safe, fails to consider the cumulative health effect of chemicals in the diet, and lacks any systematic reassessment of past decisions even when new evidence shows potential harm.

FDA needs to step up and address these shortcomings to make our food safe and restore consumer confidence. This involves not only improving its approach to addressing ingredient safety but also their approach towards contaminants that enter our food from the environment, from the packaging, or from food processing.

Read More »

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