EDF Health

How TSCA implementation could be derailed by Pruitt’s planned directive forcing EPA to ignore science

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

Several of us at EDF listened in last Friday to a webinar hosted by a committee of the American Bar Association that featured Dr. Nancy Beck, Deputy Assistant Administrator in the office of the Environmental Protection Agency (EPA) that administers the Toxic Substances Control Act (TSCA).

Dr. Beck was asked during the Q&A whether EPA was actively working on drafting risk evaluations for the first 10 chemicals TSCA required EPA to identify, even though their long-awaited “problem formulations” have not yet been made available to the public for comment.  Dr. Beck replied that, indeed, the agency was hard at work on the risk evaluations, noting that there are “thousands of studies” agency staff have identified relevant to those 10 chemicals that need to be reviewed.

What struck me about that comment, which in and of itself is not at all surprising, is that it was made just a week after news broke that Dr. Beck’s boss, EPA Administrator Scott Pruitt, plans to direct agency staff to reject large numbers of scientific studies from consideration in policy making at the agency.   Read More »

Posted in Health policy, Health science, Industry influence, TSCA reform / Tagged | Comments are closed

New Study Says Lead – Even at Low Levels – is Associated with Risk of Premature Death

Dr. Ananya Roy is Health Scientist and Tom Neltner, J.D. is Chemicals Policy Director

This week, a team of researchers led by Dr. Bruce Lanphear published an important new study on the deadly impact of lead exposure for adults. The researchers examined data on more than 14,000 adults and found that an increase of 1 to 6.7 micrograms of lead per deciliter of blood (µg/dL) was significantly associated with an increase in mortality of 37% for all-causes, 70% for cardiovascular, and 108% for ischemic heart disease. The findings remained significant even after they considered and accounted for other factors that could have explained this effect.

This research fills a gap identified by the National Toxicology Program in 2011 in our understanding of the risk of lead exposure at low levels in adults. And it goes further by providing a quantitative relationship crucial to better evaluating the potential economic benefits of various policy options.

The study also had startling estimates about how many people are hurt by lead exposure. The authors estimated that over 400,000 Americans every year die from lead related illnesses – ten times higher than previous assessments. That’s on par with deaths from smoking cigarettes.

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A path to leadership: Food packaging product stewardship considerations released

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

Last week, we spent two days at a Chemical Watch food packaging conference with manufacturers and suppliers trying to better understand the process for bringing innovative products to market. They learned what the Food and Drug Administration (FDA) and other countries will demand and what challenges they need to anticipate. While regulatory aspects are complicated, the attendees often talked about the difficulties of navigating requirements from companies and reacting to consumer expectations about packaging chemicals.

These concerns were timely. On March 9, the Food Safety Alliance for Packaging (FSAP), a part of the Institute of Packaging Professionals, released “Food Packaging Product Stewardship Considerations,” a set of best practices. This marks the first public recognition by a sector of the packaging industry of the expectations and demands from food manufacturers, retailers, and consumers.

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Too little, too fast: EDF comments raise numerous concerns with EPA’s proposal to expand use of a toxic chemical

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

Last month EDF blogged about  our request to the Environmental Protection Agency (EPA) to extend the illegally and unreasonably short 15-day comment period it had provided on a modification EPA is proposing to make to expand the ways a toxic chemical could be used, subject to certain conditions, without triggering any requirement to first notify EPA.  Specifically, EPA is proposing to modify the Significant New Use Rule (SNUR) applicable to the chemical – which currently limits its use to metalworking fluid – to allow the chemical also to be used as an anti-corrosive agent in in oilfield operations and hydraulic fluids.

Our request  also noted that EPA had failed to provide the public with anything approaching a complete set of documents relevant to its proposal.  For example, the public docket for the proposed modified SNUR lacked even a redacted copy of the Significant New Use Notice (SNUN) that triggered EPA’s consideration of the expanded use.

EPA’s proposal to amend the SNUR noted that, while EPA was expanding the allowable uses of the chemical, it was also proposing to impose additional conditions on the use.  These conditions were necessary, EPA argued, because of “test data on the substance and on new data regarding the expected release of formaldehyde from the substance, for skin and eye irritation, neurotoxicity, mutagenicity, oncogenicity, allergic responses, and developmental toxicity.”

Yet the docket did not include copies of these health and safety studies or the test data, despite being referred to in the proposal and in other documents that are in the docket.  As a reminder, such health and safety studies and their underlying data must be made public under the Toxic Substances Control Act (TSCA).  And of course, access to them is crucial if the public is expected to comment on EPA’s proposal.

A few days before the end of the 15-day comment period, EPA did grant a 17-day extension.  It also added a copy of the SNUN to the docket.  But it failed to add any of the health and safety studies or associated data we had identified as missing.

The comment period ended yesterday, and despite the serious time constraint and information gaps, EDF filed these extensive comments last night.  In preparing our comments, however, we found that the amount of health and safety data EPA had failed to provide is even greater than we had originally thought.  And our concerns over the adequacy of EPA’s review of this new proposed use and of the conditions it proposes to include in the modified SNUR have only grown.   Read More »

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Washington State takes action to eliminate use of PFAS in food packaging

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

Around 1990, driven by a concern to keep heavy metals out of recycled products, many states adopted laws prohibiting the intentional addition of arsenic, cadmium, lead, and mercury to packaging and limited their total concentration to 100 parts per million. Manufacturers and suppliers of packaging and packaging components in these states were also both required to furnish a Certificate of Compliance to the packaging purchaser and provide a copy to the state and the public upon request. The Toxics in Packaging Clearinghouse currently reports that 19 states have adopted this type of legislation.

Out of concern about consumer’s health and contamination of compost, on February 28, 2018, Washington State extended its heavy metal packaging law in a groundbreaking way. The legislature passed HB-2658 banning the intentional use of “perfluoroalkyl and polyfluoroalkyl substances” (PFAS) in food packaging made from plant fibers, pending a determination by the Washington Department of Ecology that safer alternatives are available. The law defines PFAS as “a class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom.”

The ban goes into effect in 2022 or two years after the Department makes the safer alternative determination, whichever is later.[1] If, after evaluating the chemical hazards, exposure, performance, cost, and availability of alternatives, the Department does not find safer alternatives by 2020, it must update its analysis annually. We anticipate that this approach will spur innovation among companies offering alternatives and provide a thoughtful and rigorous review of the options.

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Posted in FDA, Food, Health policy, Health science, Public health / Tagged , , , , , | Comments are closed

ACC’s state of denial about the Lautenberg Act widens – and has further infected EPA, now in its fee rule

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

I was on vacation last week, so I missed two notable pronouncements from the American Chemistry Council (ACC) regarding the 2016 reforms to the Toxic Substances Control Act (TSCA) and implementation of them by the Environmental Protection Agency (EPA).

One was a statement issued by ACC upon publication of EPA’s proposed “TSCA fee rule” in the Federal Register on February 27.  The other was remarks given by Cal Dooley, ACC’s CEO and President, to kick off the chemical industry annual GlobalChem meeting on March 1.  Let me start with the fee rule.   Read More »

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