EDF Health

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 9, 2019

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.

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Posted in FDA, Food, Health science, PFAS / Tagged , , , | Read 2 Responses

Trump EPA caves again to industry demands on new chemicals, and workers pay the price

By / Published: August 8, 2019

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

Isocyanates are nasty chemicals, including when they are left over as residuals after manufacturing other chemicals.  Here are the kinds of risks they pose, according to the National Institute for Occupational Safety and Health (NIOSH):

Isocyanates are powerful irritants to the mucous membranes of the eyes and gastrointestinal and respiratory tracts.  Direct skin contact can also cause marked inflammation.  Isocyanates can also sensitize workers, making them subject to severe asthma attacks if they are exposed again. There is evidence that both respiratory and dermal exposures can lead to sensitization.  Death from severe asthma in some sensitized subjects has been reported.

In prior reviews of new chemicals under the Toxic Substances Control Act, EPA has repeatedly indicated that “[i]socyanate exposure has been identified as the leading attributable cause of work-related asthma, and prevalence in the exposed workforce has been estimated at 1-20 percent.”

Both NIOSH and EPA have raised even greater concern over activities involving spray application of chemicals containing isocyanates.  In 2006, NIOSH issued a rare alert calling for workers to undergo medical surveillance and wear high-efficiency respirators and gloves when engaged in such activities.

Even in the recent past, when reviewing new chemicals containing isocyanate residuals, EPA has typically (1) issued a consent order subjecting the company submitting the chemical for review to multiple conditions in order to limit workplace inhalation exposures to the residuals, and (2) followed up with a Significant New Use Rule (SNUR) that extends those conditions to other companies, requiring them to notify EPA prior to engaging in any activity that exceeds those workplace limits.  And the only case since TSCA was amended in 2016 where EPA found a new chemical “presents an unreasonable risk” – as opposed to the more common, lower-bar finding that it “may present an unreasonable risk” – involved residual isocyanates present after manufacture of two new chemicals.

In such cases EPA has imposed some combination of three types of conditions on manufacture of such chemicals:  prohibitions on activities that could generate inhalable forms of the chemical and result in inhalation exposures; strict requirements for the use of high-efficiency respirators and gloves; and a strict limit on the amount of isocyanate residuals allowed to be present in the new chemical, typically in the range of 0.1% to 0.2%.

So it is quite disturbing to see how EPA has dealt with the most recent such new chemical for which EPA has issued its final decision – which requires that companies employ NONE of these protections.  Read More »

Posted in Health policy, Industry influence, Regulation, TSCA reform, Worker safety / Tagged , , , | Comments are closed

ASDWA releases useful guidance to help states develop lead service line inventories

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 7, 2019

Tom Neltner, J.D., Chemicals Policy Director and Lindsay McCormick, Program Manager

As we have explained in past blogs, it is critical that states have rough estimates of how many lead service lines (LSLs) each drinking water utility in the state may have in order to develop sound policy decisions and set priorities. Congress recognized the importance of LSL inventories when it directed the Environmental Protection Agency (EPA) in the America’s Water Infrastructure Act of 2018 to develop a national count of LSLs on public and private property in the next round of the 2020 Drinking Water Infrastructure Needs Survey. States have a crucial supporting role in the Needs Survey since it is the basis of allocating State Revolving Loan Funds to the states.

This month, the Association of State Drinking Water Administrators (ASDWA) released a useful guidance document to help states develop LSL inventories. The guidance builds on the lessons learned from:

  • Mandatory surveys conducted by California, Illinois, Michigan, and Wisconsin;
  • Voluntary surveys conducted by Indiana, Massachusetts, North Carolina, and Washington; and
  • Responses to requests for updated Lead and Copper Rule (LCR) service line preliminary materials inventories conducted by Alabama, Louisiana, Kansas and Texas.

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Posted in Drinking water, Lead / Tagged , , , , , | Comments are closed

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 5, 2019

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

[pullquote]

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).

[/pullquote]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.

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Posted in FDA, Food, Health science, PFAS / Tagged , , , | Read 1 Response

FDA concluded PFAS in food are safe. Now it has to show how it reached that conclusion.

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 1, 2019

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

In June, the Food and Drug Administration (FDA) posted a webpage that serves as a helpful starting place to learn about the agency’s efforts and plans regarding per- and poly-fluoroalkyl substances (PFAS) in food. The webpage explains that FDA is “assessing food for PFAS through sampling” and is “reviewing the limited authorized uses of PFAS in food contact applications.” In a statement accompanying the webpage’s release, FDA’s acting and deputy commissioners assured the American people that the agency “does not have any indication that these substances are a human health concern, in other words a food safety risk in human food, at the levels found in this limited sampling.”

We were surprised by FDA’s statement that all is fine given the results the agency published and the evidence about the array of health risks posed by PFAS at extremely low levels. Although the information posted is useful, we found it confusing and vague in some important aspects. Therefore, we are taking the opportunity here to raise some issues concerning FDA’s statements and planned next steps on PFAS. Additionally, in another 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.

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

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

By Lindsay McCormick / Published: July 31, 2019

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.

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Posted in Emerging science, Emerging testing methods, Health science, Public health / Tagged , | Read 1 Response