Monthly Archives: November 2018

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

By Richard Denison / 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.

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.

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Posted in Drinking water, FDA, Food, Health policy, PFAS, Public health, Regulation / Tagged , , , , | Read 1 Response