EDF Health

EPA needs to stop misleading the public and its peer reviewers about the data it has obtained from the European Chemicals Agency

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

In numerous assessment documents issued by the Environmental Protection Agency (EPA) developed in its implementation of the Toxic Substances Control Act (TSCA), EPA cites as a source the European Chemicals Agency (ECHA).  ECHA is the agency that administers the European Union’s (EU) REACH Regulation, which (unlike TSCA) requires the registration of chemicals in commerce by companies that wish to continue to produce and use the chemicals in the EU.

When companies register chemicals under REACH, they are required to develop and submit a “dossier” of certain information on production and use as well as on physical-chemical properties, fate, hazard, exposures and risks.  ECHA then makes information available on its website.

In its draft risk evaluations for the first 10 chemicals undergoing evaluations under TSCA, as well as in some of its support documents for high-priority substance designations under TSCA, EPA has heavily relied on these dossiers.  But in doing so, EPA has grossly mischaracterized the source and nature of the data it references as coming from ECHA.

EDF has been raising concerns about EPA’s mischaracterizations for some time now (see section 1.E of our comments on EPA’s draft risk evaluation for 1,4-dioxane), but they persist.  And as recently as yesterday, members of the peer review panel reviewing EPA’s draft documents have been led by EPA statements and citations to assume a degree of completeness and government review of these data that is simply false.

EPA needs to immediately cease and desist in its mischaracterizations.  Read More »

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

1,4-dioxane: The case of the disappearing tumors

Rachel Shaffer is a consultant.  Richard Denison, Ph.D.is a Lead Senior Scientist.

As we highlighted in a previous post, EDF filed extensive comments on EPA’s draft risk evaluation for 1,4-dioxane. Among the many concerns we raised was a decision by the Trump EPA to completely dismiss female mouse liver cancer data used by EPA’s Integrated Risk Information System (IRIS) program as key inputs to its cancer risk modeling conducted in 2013. The Agency appears to be trying every trick in the trade – such as excluding most exposure sources and routes – in its effort to conclude that the chemical presents few or no risks to human health or the environment. Read on for more on this latest one. Read More »

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

Should EPA grant industry’s hypocritical request to now address 1,4-dioxane’s risks as a byproduct, it must meet a number of conditions

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

Environmental Defense Fund (EDF) submitted extensive comments last week to the Environmental Protection Agency (EPA) that raise numerous serious concerns with EPA’s draft risk evaluation for the likely human carcinogen 1,4-dioxane.  EDF’s comments are available here.

I want to use this post to highlight one of the many issues:  For years, the industry has urged EPA not to include 1,4-dioxane’s presence as a byproduct in various formulated products within the scope of its risk evaluation for the chemical; see comments specific to 1,4-dioxane from the American Cleaning Institute, Procter & Gamble, and the Household & Commercial Products Association; and more general comments urging exclusions for byproducts and “trace levels” from the American Chemistry Council and the Consumer Specialty Products Association Comment.

Not surprisingly, the Trump EPA’s draft risk evaluation for 1,4-dioxane did just that, a major problem EDF objected to on legal and scientific grounds.

Then in late July, the industry abruptly reversed itself.  A comment letter submitted to EPA by the American Cleaning Institute and the Grocery Manufacturers Association says the industry has changed its mind and is now calling on EPA to include 1,4-dioxane’s presence as a byproduct as a condition of use in its risk evaluation.

Why the shift?  At this late hour it has dawned on the industry groups that any final action by the agency on the chemical that excludes 1,4-dioxane’s presence as a byproduct as a condition of use in its risk evaluation will not preempt states from acting to regulate this condition of use.

The industry’s hypocrisy aside, if EPA decides to grant this industry request, which has arrived long after EPA initiated the risk evaluation process, EPA should do so only subject to conditions that are critical to meet if its decision and risk evaluation are to maintain any semblance of credibility:

  • EPA needs to use its mandatory information authorities to require the submission and development of relevant information on the presence of 1,4-dioxane as a byproduct in industrial, commercial and consumer materials and products, as input into a revised draft risk evaluation.
  • EPA must promptly make all such information it receives public, subject only to redactions of information claimed confidential by the submitters that EPA determines meet all applicable requirements of TSCA section 14. It should be noted that much of the relevant information will constitute health and safety information that is not eligible for protection under section 14 and must be made public.
  • EPA needs to carefully and thoroughly develop and fully integrate an analysis of the potential exposures and risks arising from the presence of 1,4-dioxane as a byproduct into all aspects of its risk evaluation, given that inclusion of the presence of 1,4-dioxane as a byproduct will affect all of the exposure and risk estimates EPA has examined in the current draft risk evaluation.
  • EPA must publish a revised draft risk evaluation for public comment, providing the public with ample time to review the new draft and develop meaningful comments.
  • EPA must subject its revised draft risk evaluation to full peer review by the Scientific Advisory Committee on Chemicals (SACC), providing the committee with ample time to review the new draft and develop meaningful comments.

Any credible evaluation of the contribution to 1,4-dioxane’s overall health and environmental risks due to its presence as a byproduct must be based on complete, reliable information that is publicly accessible, and must reflect input from both the public and expert peer reviewers.  For EPA to do anything less will simply cast yet more doubt on its trustworthiness and independence from industry interests.


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

Chemours asks FDA to suspend its approved uses of PFAS in food packaging

Tom Neltner, J.D.Chemicals Policy Director

Politico reported today that Chemours notified the Food and Drug Administration (FDA) that it had officially abandoned its three approved food packaging uses of per- and poly-fluorinated alkyl substances (PFAS) and asked the agency to withdraw its Food Contact Substance Notifications (FCNs) for those uses. We do not know with certainty what prompted Chemours to abandon its PFAS products for food packaging or whether they were ever used in the United States. Based on past experience, we anticipate that FDA will grant the request.

This action takes us one step closer to reducing people’s exposure to these chemicals linked to an array of health risks posed by PFAS at extremely low levels. Additionally, the action should serve as an incentive for other companies to do the same.

Chemours also has FCNs for six PFAS uses in repeat-use food contact articles like gaskets and seals. The company apparently has not asked the agency to abandon these uses. We suspect that the PFAS-treated gaskets may still be in service even if it has stopped treating new gaskets with the chemicals.

Read More »

Also posted in FDA, Food, GRAS, PFAS / Tagged , , , | Read 2 Responses

FDA must abandon its flawed assumptions when reviewing safety of approved PFAS uses in food

Tom Neltner, J.D.Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant

All the PFAS uses allowed by FDA that we reviewed had estimated exposures exceeding the most protective minimal risk level for PFOS proposed by the Centers for Disease Control and Prevention (CDC).

In its June 2019 release of a webpage dedicated to per- and poly-fluoroalkyl substances (PFAS) in food, FDA stated that it is “reviewing the limited authorized uses of PFAS in food contact applications.” As we mentioned in a previous blog, we were pleased to see FDA’s public position on PFAS but we highlighted three major concerns that could impact the ongoing safety review and questioned the conclusion that all is fine. In this blog, we discuss the implications of FDA’s statements on its review of 62 authorized PFAS uses in contact with food and make recommendations to the agency as it proceeds with this promising effort.

Read More »

Also posted in FDA, Food, GRAS, PFAS / Tagged , , , | Read 1 Response

Why do we know so little about chemical exposures? Emerging technology could disrupt the status quo.

Lindsay McCormick is a Program Manager.

EDF report identifies emerging market for personal chemical exposure monitoring technologies through a first-of-its-kind analysis.

When I first started working at EDF in 2014, I learned a statistic that shocked me: We have human exposure data on less than 4% of the roughly half-million chemicals in commerce.[1] In other words, we know next to nothing about the vast majority of chemical exposures that people were experiencing on a daily basis.

Chemicals are found in nearly all commercial products and serve a foundational role in our economy. Yet this ubiquity comes with its downsides, as some chemicals are hazardous and can find their way into our environment and ultimately end up in our water, land, and air—and in our bodies. Exposure to certain chemi­cal substances have been linked to a variety of adverse health impacts, including reproductive harm, disruption of normal hormone activity, and impaired neurological development in children.

The lack of knowledge about chemical exposures poses a major problem: Without better information on exactly which chemicals individuals are exposed to every day, it is challenging to develop effective policies and interventions to reduce harmful exposures and protect health.

Disrupting the status quo

But what if anyone could use a simple home-delivered kit or wearable device to reveal the chemicals in their environment—and in their body? Such technologies could make the invisible visible—providing individuals, as well as policy makers, businesses, health professionals, and others, with critical information needed to accelerate reductions in the public’s exposure to hazardous chemicals.

In 2017, EDF pursued a Year of Innovation to better understand opportunities to advance the market for personal chemical exposure monitors (PCEMs) – with the ultimate goal of improving public health. As part of this effort, we conducted interviews and convened an expert workshop to identify bottlenecks in the development and use of such technologies.

We learned that a significant gap exists between the demand and promise of PCEM technologies and the current cost or scalability of many of the available technologies today. Experts noted that while there is significant qualitative or anecdotal evidence of demand, a quantitative understanding of the potential market for these technologies is needed to drive a robust market.

EDF took that lesson and embarked on a two-part study to fill this gap.

Read More »

Also posted in Emerging Science, Emerging Testing Methods, Innovation, Public Health / Tagged , | Read 1 Response