EDF Health

Exhibit PV29: Why this EPA can’t be trusted to forthrightly assess chemical risks under TSCA

By / Published: December 13, 2018

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

I blogged last week about the Environmental Protection Agency’s (EPA) illegal and hypocritical decision to deny the public access to health and safety studies conducted on the first chemical to undergo a risk evaluation under the reformed Toxic Substances Control Act (TSCA).  In its draft risk evaluation, now out for public comment, EPA relied on these secret studies to assert that the chemical, commonly known as Pigment Violet 29, or PV29, is safe, so EPA’s denial of public access matters a great deal.

EPA asserts that these studies are entitled to protection as confidential business information (CBI) under TSCA, when in fact TSCA explicitly does not extend CBI protection to such studies.  The only health and environmental information on this chemical that is public are brief summaries of those studies that were prepared by the companies that make the chemical, and were submitted to the European Chemicals Agency (ECHA) when the chemical was registered under the European Union’s REACH Regulation.  (EPA erroneously states that the studies were “summarized by ECHA.”  This is simply not the case:  Registrants, not ECHA, develop the summaries that are then made available in the registration “dossiers” for REACH chemicals.)

As we review EPA’s draft risk evaluation for PV29, we are finding that EPA’s assertions cannot be trusted even about what these summaries state are the findings of the underlying studies.  I’ll discuss one such case in this post.   Read More »

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The Trump EPA’s latest TSCA gift to the chemical industry is illegal and the height of hypocrisy

By / Published: December 4, 2018

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

‘Tis the season for giving, but it’s not quite keeping in the spirit to have our Environmental Protection Agency (EPA) pile on giveaways to the chemical industry.  The latest one I’ll discuss in this post is not only in direct violation of the Toxic Substances Control Act (TSCA); it exposes this EPA’s two-facedness when it comes to making public the information EPA relies on in making regulatory decisions that affect our health and our environment.[pullquote]EPA’s failure to make health and safety studies available to the public is blatantly illegal and a slap in the face to the 2016 bipartisan reforms to TSCA that sought to increase public access to information on chemical risks.[/pullquote]

First some background.  It has been a long time since EPA has proposed a rule to require testing to determine the hazards of a chemical; the last time was way back in 2011.  (That proposed rule was never finalized.  And despite Congress’ major expansion of EPA’s authority to require testing when reforming TSCA in 2016, EPA has steadfastly refused to even consider use of that new authority.)

The American Chemistry Council (ACC) filed comments opposing the 2011 proposed rule.  As I blogged about at the time, ACC insisted that, instead of calling on its members to provide the health and safety data sought through the proposed rule, EPA should seek to get it from the European Chemicals Agency (ECHA). ACC asserted that ECHA likely had already received the requested data under the European Union’s (EU) REACH Regulation.  I noted that’s not as easy as it sounds, because the chemical industry itself has thrown up major roadblocks to such inter-governmental data sharing.  But here’s the rub:  ACC further argued that, should EPA succeed in obtaining the health and safety data submitted to ECHA, EPA could and should deny public access to those data – despite the fact that TSCA clearly prohibits EPA from withholding health and safety studies.  ACC added that the public should make do with mere summaries of the studies, summaries that were prepared by the companies making the subject chemicals.

At the time, EPA was having none of this.  It indicated that if necessary it could use, and was considering using, its subpoena authority under section 11(c) of TSCA to get the studies from the companies that had submitted them to ECHA; see pages 16-17 of this 2013 report from the Government Accountability Office (GAO).

That was then.  Now, with a former ACC senior official essentially running the TSCA office at EPA, the agency is virtually following ACC’s script.   Read More »

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The Trump EPA is poised to grant the chemical industry yet another of its wishes under TSCA

By / Published: November 16, 2018

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

The chemical industry has long sought to have the Environmental Protection Agency (EPA) rubber-stamp as “safe” as many of its chemicals as possible without imposing any burden on the industry to develop the information needed to actually demonstrate safety.  It has repeatedly pushed for EPA to set aside large numbers of chemicals in commerce and ensure they don’t have to undergo evaluations of their potential or actual risk.

During the debate over reform of the Toxic Substances Control Act (TSCA), various industry associations advocated for an approach that would have required EPA to quickly review all chemicals in commerce using whatever information was available (which is virtually none for the great majority of such chemicals), and set aside as “low-priority” any that EPA could not demonstrate were harmful.[pullquote]It appears EPA is trying to install a new parallel process, outside of TSCA’s statutory boundaries, that EPA will use to set aside thousands of chemicals from any further review indefinitely and with no recourse for the public.[/pullquote]When that didn’t fly (more on this below), industry commenters demanded that, in promulgating its Prioritization Rule, EPA designate long lists of chemicals as low-priority without any review.  One of the few positives of that final rule was that it rejected those calls as well.

But lest you think the issue is settled, think again.  Leave it to the Trump EPA to find an even more devious way of granting the industry’s wish.   Read More »

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FDA-approved PFAS: A serious breakdown in assessing food additive safety

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: November 4, 2018

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

This blog is the fourth in a series describing information we discovered in reviewing thousands of pages from the Food and Drug Administration’s (FDA) response to our Freedom of Information Act (FOIA) of the agency’s approval of 31 Food Contact Substance Notifications (FCNs) from 2002 to 2016 submitted by six companies for 19 distinct chemical mixtures of per- and poly-fluorinated substances (PFAS).

In this blog, we identify one company’s serious breach of its obligation to provide FDA with all relevant toxicology data. While hindsight is 20/20, we have reason to believe that if FDA had had all relevant information, it would have demanded more studies potentially revealing risks that are only now coming to light with related chemicals. Though we have not completed a similar review for the other companies, we think this inadequate approach to chemical safety is not unique to a single company, and FDA should reassess all its reviews given what is now known about PFAS chemicals.

Safety assessment requirements for food additives – including food contact substances

When a company seeks FDA’s approval of food additives (including food contact substances), it is required to provide the agency with all relevant chemistry, toxicology and environmental data so it can conduct a safety assessment. While the agency typically conducts a literature search of its own and of public databases, the company that is claiming the chemical’s use is safe is obligated to include any data that is inconsistent with the company’s conclusion.

Read More »

Also posted in Drinking water, FDA, Food, Public health, Regulation / Tagged , , , , , | Read 1 Response

Need more evidence of the chemical industry’s bad faith on TSCA? Read this.

By / Published: October 31, 2018

Richard Denison, Ph.D., is a Lead Senior Scientist.  Stephanie Schwarz, J.D., is a Legal Fellow.

This story is about chemicals known as chlorinated paraffins.  They are used as flame retardants, plasticizers and lubricants, among other things.  They come in three main versions:  short, medium, and long-chain.  Short-chain chlorinated paraffins (SCCPs) have been banned or are set to be banned in a number of jurisdictions and are listed for elimination under the Stockholm Convention.  The U.S. is not a party to Stockholm and has not banned SCCPs.  However, in 2012 EPA secured agreement from their leading domestic manufacturer, Dover Chemical Corporation, and their leading importer, INOVYN (formerly INEOS Chlor Americas, Inc.), to phase them out in consent decrees issued to settle enforcement actions EPA had brought against the companies (more on that later).

Concern over the medium and long-chain variants (MCCPs and LCCPs) has been significant and growing, however.  This is because they, like SCCPs, are expected to be very persistent and very bioaccumulative (vPvB) and, given evidence of systemic toxicity as well as toxicity to aquatic and terrestrial organisms, are also expected to be PBTs (persistent, bioaccumulative, and toxic chemicals).

The regulatory history of chlorinated paraffins under TSCA has been long and taken numerous, often troubling, turns.  We’ll only touch on some highlights here.   Read More »

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A call for urgent action: First-ever WHO conference on a killer that cuts short millions of lives a year

By Sarah Vogel / Published: October 29, 2018

Sarah Vogel, Ph.D., is Vice-President for Health.

To breathe—from our very first breath to our last—is to be alive. But for billions of people around the world, that simple, necessary act is at risk due to pollution. For the hundreds of millions of children and adults with asthma struggling to breathe, the immediate and acute experience of breathing polluted air cannot be mistaken.  And scientific research tells us that air pollution is also cutting short the lives of an estimated 7 million people a year due to heart attacks, stroke and respiratory diseases.  For some context, that is more than the total lives lost to HIV/AIDS, malaria and tuberculosis combined.

Everyone on this earth has a right to breathe healthy air.  But today, too many countries around the world are facing serious air pollution crises.  That’s why people from all around the world—government officials, civil society organizations, artists, and academics—have gathered this week in Geneva, Switzerland for the first World Health Organization Global Conference on Air Pollution and Health. And it’s why we’re here: to call for urgent and immediate action to address global air pollution.

Read More »

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