EDF Health

The elephant in the room: potential biopersistence of short-chain PFAS

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

In January 2018, US Food and Drug Administration (FDA) scientists published a peer-reviewed journal article stating a commonly used raw material to make greaseproof paper is likely to persist in the human body. FDA scientists’ sophisticated analysis and remarkable conclusion raises questions about the broad assumption that short-chain perfluorinated alkyl substances (PFAS), as a class, did not accumulate.

Strangely, two recent reviews funded by the FluoroCouncil, ignored FDA scientists’ study even though it was published ten months before the industry group submitted their analysis for peer-review. The peer reviewers appear to have missed the omission as well. As a result, the industry evaluations continue to perpetuate the flawed assumptions, concluding that perfluorohexanoic acid (PFHxA) and related short-chain PFAS “present negligible human health risk” and that this substance alone is a suitable marker for the “safety of fluorotelomer replacement chemistry.”

In this blog, we discuss the differences between the studies and the implications of the discordance between FDA’s and industry’s conclusions for the safety assessment of short-chain PFAS.

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EDF to OMB: Ban on methylene chloride in paint strippers must protect workers in addition to consumers

Lindsay McCormick, Project Manager, and Joanna Slaney, Legislative Director

Over 11,000 concerned Americans have sent messages to Members of Congress over the last two weeks to urge EPA and OMB to protect workers – the population at most risk – from methylene chloride in paint strippers.

Today, EDF met with the White House Office of Management and Budget (OMB) about the Environmental Protection Agency’s (EPA) draft final rule on methylene chloride-based paint strippers. We urged the office to ensure the ban on methylene chloride-based paint and coating removers covers both consumer and most commercial uses – as the agency originally proposed.

Removing these deadly products from stores, workplaces, and homes is a critical step to protecting public health. Methylene chloride is acutely lethal. Exposure to the chemical has led to over 50 reported worker deaths since the mid-1980s, more than 40 of which are attributed to use of methylene chloride-based paint strippers. Many more deaths have likely gone unreported. The chemical is also associated with a host of other serious health effects, including neurotoxicity, cancer, and liver impairment.

Despite the facts that workers represent the vast majority of reported deaths and face the highest risks of other health effects, it appears that EPA is poised to finalize a rule that excludes a ban on commercial uses entirely – and will instead merely initiate a lengthy, uncertain process that may lead to certification and training approaches EPA had already considered and rejected as inadequate to protect workers.

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New study: Using interactive online tools to publicize lead service line locations and promote replacement

By Sofia Hiltner, Rainer Romero, Lindsay McCormick and Tom Neltner

EDF study evaluates interactive online tools in three Ohio cities that help users know which addresses have a lead service line.

In 2016, EPA called upon states to work with drinking water utilities to make publicly available the location of lead service lines (LSLs, the lead pipes that connect the main under the street to buildings) via maps or other mechanisms. Ohio led the way with legislation requiring more than 1,800 utilities to submit static PDF maps that showed where LSLs were likely to be present and then posting the maps online. Three cities in the state took the effort a step further to communicate the information to their customers by posting online tools. In 2016, Cincinnati posted an interactive map of LSLs modeled after one posted by Washington, DC earlier that year. The next year, Columbus posted an interactive map and Cleveland posted a search engine enabling anyone to check the service line material at an address.

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How and when will FDA rule on ortho-phthalates in food? It’s anyone’s guess.

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

The Food and Drug Administration (FDA) has yet to decide three overlapping petitions requesting the agency take action on uses of ortho-phthalates in contact with food. Two of the petitions—a food additive petition and a citizen petition—were submitted by EDF, Earthjustice and nine other public health allies. In those petitions, we requested the revocation of all uses of this class of chemicals in food because the agency can no longer conclude that such use is safe. The law required FDA to make a decision by no later than September 2018; that deadline has long since come and gone, and the agency hasn’t acted.

The third petition was submitted by the Flexible Vinyl Alliance, an industry group. It requested that the agency revoke the food additive uses of 26 ortho-phthalates because, according to FDA’s notice, they had been abandoned. The agency agreed to review the petition in July 2018 and invited public comment on it in November 2018.  Public comments were due on January 14, 2019.

In a press release about its petition, the industry group announced that only four ortho-phthalates “remain relevant in food contact applications”:  di(2-ethylhexyl) phthalate (DEHP), diisononyl phthalate (DINP), dicyclohexyl phthalate (DCHP) and diisodecyl phthalate (DIDP).  It also stated that it confidentially provided the agency with exposure and safety data on these four substances. The agency has made neither the industry’s petition nor the safety data on the four ortho-phthalates publicly available. We submitted a Freedom of Information Act (FOIA) request seeking industry’s “confidential” report and more information on the petition.  We await a response.

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City of Washington, DC requires lead pipe disclosure and tackles past partial LSL replacements

Tom Neltner, J.D.Chemicals Policy Director

Washington, DC estimates there are 48,000 lead service lines (LSLs) on private property, 46 percent of the total number of service lines identified by the District. While the District has not yet set a goal of eliminating LSLs, it has taken positive steps to assist residents in replacing LSLs. It has prioritized avoiding partial LSL replacements, which are likely to increase residents’ exposure to lead, especially in the months following the disturbance.

On January 16, 2019, the District passed a new law that takes additional positive steps. First, it requires property owners to disclose the presence of an LSL to potential homebuyers and renters. The city joins Cincinnati, OH and Philadelphia, PA in requiring disclosure to renters and New York, Delaware, Connecticut, and Pennsylvania in requiring disclosure to homebuyers.

Second, it redresses past partial LSL replacements by providing financial support to homeowners who did not replace the portion on private property when they were expected to shoulder the entire burden. This is the first city we have seen take this approach. The fiscal impact statement for the law also provides insight into the cost of LSL replacement; the District of Columbia Water and Sewer Authority (DC Water), the city’s utility, estimates the average cost to replace the portion on private property is $2,000 per line. The total cost of the law over four years if fully funded is $21 million.

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FDA is dragging its feet while children continue to be exposed to perchlorate in food

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

It has been more than 18 months since EDF and other advocates challenged the Food and Drug Administration’s (FDA) May 2017 decision to continue allowing perchlorate in dry food plastic packaging and food handling equipment.

While Congress gives FDA 180 days to act on food additive petitions, FDA must act “as soon as possible” on a challenge such as ours. However, the agency has yet to complete a review of its May 2017 decision in light of our concerns and evaluate whether to either stand by it, or reverse it. We did not expect FDA would take three times longer to review a decision already made, especially since our objection is largely based on the agency’s own data.

In the meantime, perchlorate in food continues to threaten children’s brains. The chemical, a component of rocket fuel, disrupts the thyroid gland’s normal function and reduces production of the thyroid hormone needed for healthy fetal and child brain development. FDA’s own studies show increased levels of perchlorate in foods such as baby food dry cereal, indicating the chemical’s intentional use in dry food packaging is the likely source of increased exposure for young children.

How FDA got it wrong

In FDA’s May 2017 decision to continue allowing intentional use of perchlorate in contact with dry food, the agency largely relied on flawed science to assess dietary exposure. Its three central errors were:

  1. Ignoring its own data showing significantly increased exposure for children;
  2. Woefully underestimating exposure based on a flawed migration test; and
  3. Unrealistically assuming that perchlorate-laden plastic would only contact food once.

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