EDF Health

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 »

Posted in Health policy, Industry influence, TSCA reform / Tagged , | Read 1 Response

Lead from a new “lead-free” brass faucet? More common than you’d hope

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: November 6, 2018

Tom Neltner, J.D. is the Chemicals Policy Director and Lindsay McCormick is a Project Manager.

[pullquote]Until NSF/ANSI 61 standard is updated to reduce or eliminate lead leaching, users must extensively clean and flush new brass fixtures before use and make a short flush standard practice for older fixtures.[/pullquote]

During this past year, we undertook a pilot project to tackle the problem of lead in drinking water at child care facilities. As part of the effort, we collected 250 mL samples (about 8 ounces of water) from every drinking water fixture, as recommended in the Environmental Protection Agency’s (EPA) 3Ts guidance for schools and child care facilities. We replaced 26 faucets that exceeded our action level with new brass faucets that were labeled “lead-free” and complied with NSF/ANSI 61 standard for drinking water system components.[1] To our surprise, when we sampled the faucets a few days after replacement, the lead levels were higher– between 9 and 10 ppb – on three of the new faucets.

The increase left us scratching our heads. Federal law allows a drinking water fixture to be labeled “lead-free” if the amount of lead in wetted surfaces[2] averages less than 0.25% (down from the 8% limit between 1986 and 2014). However, it isn’t clear how much this amount might contribute to levels of lead in water. To explore this issue, we contacted the supplier who said its product was certified under NSF/ANSI 61 and, therefore, not likely the source. The supplier suggested the source could be from existing upstream valves or from disturbing the plumbing. We could not rule these other possibilities out.

A study by Virginia Tech’s Jeff Parks on three models of new NSF/ANSI 61 certified brass faucets found similar results and concluded that even newly manufactured “lead-free” faucets may not meet the 1 ppb limit that the American Academy of Pediatrics (AAP) recommends for schools.

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

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.

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Posted in Drinking water, FDA, Food, Health policy, 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 »

Posted in Health policy, Industry influence, Regulation, TSCA reform / Tagged , , | Read 1 Response

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.

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Posted in Air pollution, Health policy, International / Tagged , , , | Comments are closed

FDA reduces maximum daily limit for lead in children’s food by half

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: October 25, 2018

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

On September 27, 2018, the Food and Drug Administration (FDA) reduced the maximum allowed daily intake of lead for children from 6 to 3 micrograms per day (µg/day). It has also set a limit for adults of 12.5 µg/day, to protect against possible fetal exposure in women who are unaware they are pregnant and to reduce infant exposure during nursing. The agency now refers to these limits as the “Interim Reference Level” to match the Centers for Disease Control and Prevention’s (CDC) terminology for elevated blood lead levels that warrant action. FDA reports that the new level for children is the amount of lead in food expected to result in a blood lead level of 5 µg/deciliter, with a 10-fold safety factor to account for differences across the population.

This change is a major step in FDA’s new push to limit heavy metals in food to protect children’s neurological development. In April 2018, FDA explained that its Toxic Elements Working Group is “looking at all the [heavy] metals across all foods rather than one contaminant, one food at a time,” and that “even though the level of a metal in any particular food is low, our overall exposure adds up because many of the foods we eat contain them in small amounts.”

As the agency indicated earlier this year, the next step for the Working Group is to “begin reevaluating the specific lead levels that FDA has set for a variety of foods.”

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