Monthly Archives: April 2020

Tightening lead leaching standards for new drinking water fixtures – Opportunity for public comment

Tom Neltner, J.D. is the Chemicals Policy Director

Update: In September 2020, the joint committee announced it revised the NSF/ANSI/CAN 61 standard.

On May 11, 2020, EDF and EWG jointly filed comments to NSF International supporting proposed changes to the NSF/ANSI/CAN 61 Standard.

We have a legacy of lead in our pipes, our paint, and our soil. These are the most significant sources of human lead exposure and, therefore, draw most of the attention and resources because they are costly to fix. It is also important to limit lead from new sources to avoid adding to that environmental burden. For that reason, EDF has sought, as part of our larger efforts, to reduce the amount of lead that leaches from new plumbing devices such as faucets and fountains.

Thanks to the leadership of California Assembly Member Chris Holden, a collaboration with Environmental Working Group, and a productively and collaboratively engaged Plumbing Manufacturers International (PMI), the trade association that represents the manufacturers that provide 90% of the plumbing products sold in the United States, we are seeing real progress from our efforts. We wanted to update you on two parallel, but related, developments:

  • A proposal to revise the current U.S. consensus national standard NSF/ANSI/CAN 61; and
  • California Assembly Bill AB 2060 to revise 116875 of the California Health and Safety Code.

These changes are needed because the current federal limit of 0.25% of lead by weight is insufficient to ensure that lead levels in drinking water are as low as possible, especially during the first few weeks of use before they are conditioned to the water. With these changes, buyers will be able to identify and purchase new devices that should meet the American Academy of Pediatrics recommended action level of one part per billion.

If all goes as anticipated, the more stringent NSF standard will be in place by the end of the year, manufacturers will begin the process of certifying products to the more protective lead limits, and there will be sufficient certified devices on the market in California to meet the anticipated demand from child care centers.

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

FDA scientists push back on an industry-funded analysis about bioaccumulation and toxicity of short-chain PFAS

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

Note to readers: As we all grapple with the grave global health challenge from COVID19, we want to acknowledge the essential services that professionals at the Food and Drug Administration (FDA) and in the food production, processing and retail industries provide in continuing to deliver food. In the meantime, we are continuing to work towards improved health protections – including reducing chemicals in food. We’ll plan to keep sharing developments that may be useful to you. In the meantime, please stay safe and healthy.

Last year, we reported on a sophisticated analysis performed by FDA’s scientists showing that 5:3 acid, a breakdown product of a short-chain PFAS known as 6:2 fluorotelomer (6:2 FTOH) was slow to be eliminated by the body. The authors concluded that the metabolite was an important biomarker for assessment of long-term exposure to 6:2 FTOH and showed potential bioaccumulative (aka biopersistence[1]) properties. The chemical 6:2 FTOH is a common starting substance in the manufacture of many PFAS polymers, including those used to greaseproof paper and paperboard. As a result, it is a major impurity in, and degradation product of, these polymers.

We are now reporting on two recent publications by the same group of FDA scientists (Kabadi et al.[2] and Rice et al.)[3] in which they not only confirmed their initial findings but also produced new evidence on the behavior of short-chain PFAS when they enter the body. The new evidence highlights:

  • Bioaccumulation: 6:2 FTOH is transformed by the body into several metabolites; one of them, called 5:3 acid, bioaccumulates, and the bioaccumulation is greater with lower exposure to 6:2 FTOH.
  • Toxicity: The toxicity of 6:2 FTOH is concerning and its risk to human health may have been significantly underestimated previously. Data on perfluorohexanoic acid (PFHxA), the industry’s proposed reference chemical for the short-chain PFAS class are not appropriate for assessing the potential health effects of 6:2 FTOH.

The FDA’s scientists reached these important conclusions after reviewing “recently received additional data on 6:2 FTOH and 5:3 acid” and more than a dozen reports on oral toxicity studies that “had been conducted and submitted by industry in support for food contact uses” of short-chain PFAS in addition to a study by the National Toxicology Program. They also called out flaws in industry-funded analyses that reached different conclusions.

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

Peer reviewers of EPA’s TCE report must affirm that the key risk is fetal heart damage

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

Last week, the EPA Science Advisory Committee on Chemicals (SACC) conducted a virtual peer review meeting for the Agency’s draft risk evaluation of trichloroethylene (TCE). As expected, there was substantial discussion on the appropriateness of EPA’s decision to make risk determinations based on immune endpoints rather than fetal cardiac malformations (FCMs). Unfortunately, the review panel lacked anyone with specific expertise in cardiac development.

During the meeting, many of the peer review panelists signaled an initial inclination toward supporting EPA’s decision to use immune endpoints for risk determinations. However, panel members also noted with serious concern the recent investigations that have uncovered political influence exerted on EPA that led it to base the risk determinations in the draft risk evaluation on immune endpoints instead of FCMs.

Stepping back from the specifics of the discussions last week, it is important to understand the longstanding basis and support for EPA’s reliance on FCMs, the unprecedented nature of EPA’s decision to now move away from it, and the adverse implications of the decision for EPA’s ability to adequately manage the risks of TCE to all relevant subpopulations.

This decision is a major departure from thoroughly peer-reviewed science, fails to protect the most sensitive populations as mandated by TSCA, and deviates dramatically from existing Agency guidance. These concerns, discussed at length in EDF’s comments in the TCE Docket, are briefly summarized below:  Read More »

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