EDF Health

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 1, 2020

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

Every lead service line replaced yields an estimated $22,000 in reduced cardiovascular disease deaths

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: February 20, 2020

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

See all blogs in our LCR series.

Using publicly available information from the Environmental Protection Agency (EPA), EDF estimated that fully replacing the 9.3 million lead service lines (LSL) in 11,000 community water systems (CWS)[1] across the country would yield societal benefits of more than $205 billion, or about $22,000 per LSL removed. This estimate is based solely on reducing lead exposure in adults in order to have fewer cardiovascular disease (CVD) deaths over 35 years. It does not include the benefits to children’s brain development.

We submitted our analysis in comments to EPA on its proposed revisions to the Lead and Copper Rule (LCR), the federal regulation that limits lead in drinking water. Given the magnitude of the benefits, we called on the agency to incorporate CVD mortality into its economic analysis and consider strengthening its proposal by requiring full LSL replacement as an integral part of every CWS’s efforts, instead of as a last resort when lead levels get too high.

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

A closer look at the environmental justice implications of EPA’s proposed lead in water rule

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: February 4, 2020

Tom Neltner, J.D., Chemicals Policy Director, Lindsay McCormick, Program Manager, and Sam Lovell, Project Manager.

See all blogs in our LCR series.

[pullquote]

“Household-level changes that depend on ability-to-pay will leave low-income households with disproportionately higher health risks.”

 

– EPA Environmental Justice Analysis of the proposed rule.

[/pullquote]Reviewing a rulemaking docket can be intimidating, especially for a major rule like the Environmental Protection Agency’s (EPA) proposed revisions to its Lead and Copper Rule (LCR), which includes 853 supporting documents and tens of thousands of pages. Though we cannot claim to have read all of the documents, we did a targeted scan of key materials, knowing that they often yield insights and results that are lost in the summary that appears in the Federal Register. 

The effort for us paid off when we read EPA’s Environmental Justice (EJ) Analysis of the LCR proposal revisions (the Proposal), commissioned in response to Executive Order 12898. The Order directs agencies to identify and address, “as appropriate, disproportionately high and adverse human health or environmental effects of its programs, policies, and activities on minority populations and low-income populations” in rulemaking. The agency’s contractor essentially found:

  • The current LCR disproportionately impacts low-income and minority populations as they are more likely to live in older housing that has lead service lines (LSLs), the most significant source of lead in drinking water.
  • The Proposal’s corrosion control requirements should help reduce current disparities. Because water treatment is consistent across an entire community, stronger requirements that reduce the ability of lead to leach into water from LSLs, leaded solder, and other sources should mitigate, but not eliminate, the disproportionate burden in homes with LSLs.
  • The Proposal may make disparities worse if it depends on individual household’s ability to pay for LSL replacement (LSLR). The report stated that “Household-level changes that depend on ability-to-pay will leave low-income households with disproportionately higher health risks.”[1]

In the Federal Register notice, EPA glossed over the third point and concluded that the Proposal is “not expected to have disproportionately high and adverse human health or environmental effects on minority populations and low-income populations.”[2] The agency ignores the fact that the Proposal makes no change to the current LCR provisions that rely on a household’s ability to pay when it says water systems are “not required to bear the cost of removal of the portion of the [LSL] it does not own.”[3] We are aware of only a small – but growing – number of communities that have funding options to assist households with the cost of LSLR on private property.

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

When it comes to testing heavy metals in food, the result is only as good as the lab.

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: January 23, 2020

Tom Neltner, J.D., Chemicals Policy Director and Boma Brown-West, Senior Manager.

[pullquote]

“Even though the levels 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.”

 

Dr. Conrad Choiniere, leader of FDA’s Toxic Elements Workgroup on April 20, 2018

[/pullquote]

Heavy metals such as arsenic, cadmium, and lead are present in most foods, whether conventional or organic, usually as the result of environmental contamination. Because heavy metals pose significant threats even at low levels, the Food and Drug Administration (FDA) has made reducing cumulative exposure a priority. The Baby Food Council – consisting of Beech-Nut Nutrition Company, Happy Family Organics, Earth’s Best, and Gerber Products Company and supported by Healthy Babies Bright Futures (HBBF), Cornell University and EDF – shares this goal and seeks to reduce heavy metals in the companies’ products to as low as reasonably achievable using best-in-class management practices.

Through the Council, EDF is coordinating a proficiency testing program to enable retailers, food manufacturers, ingredient suppliers, and others to identify laboratories that are capable of measuring arsenic, cadmium, and lead at levels in the low parts per billion (ppb). The Council has arranged for FAPAS, a leading proficiency testing provider for the food and water testing industries, to manage the testing program.

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Posted in FDA, Food, Health science, Lead / Tagged , , , , , | Comments are closed

Which faucets and fixtures have the lowest lead levels? California asks plumbing manufacturers.

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: December 13, 2019

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

[pullquote]

Until California Water Board publishes its lists of fixtures that leach minimal lead, we recommend that schools and child care facilities routinely flush newly installed drinking water fixtures for several weeks and retest before allowing children to consume the water.

[/pullquote]

In November, the California Water Board took an important step that should benefit anyone seeking to buy a new faucet, drinking water fountain or other fixture – especially schools and child care facilities. The Board sent letters to more than 300 plumbing manufacturers and certifiers asking them to voluntarily provide information on fixtures that leach minimal lead. Specifically, it seeks to identify fixtures that meet lead leaching limits that are five times more protective than the current limits in the NSF/ANSI 61 standard.

The Board plans to make the compiled responses publicly available and encourage the 14,000 licensed child care centers in the state to buy new fixtures from those on the list when water testing indicates the fixture should be replaced. We anticipate that the Board will utilize the list to identify fixtures to purchase through a $5 million grant program the California State General Legislature established when it enacted AB-2370 last year. The funds are designed to help licensed child care facilities meet the state’s new mandated water testing and remediation program.

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

EDF asks EPA to strengthen key lead service line definition, inventory, and notification provisions in its proposed revision to the LCR

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: December 13, 2019

Tom Neltner, J.D., Chemicals Policy Director, Lindsay McCormick, Program Manager, and Sam Lovell, Project Manager.

See all blogs in our LCR series.

Yesterday, EDF submitted comments to the Environmental Protection Agency (EPA) on their proposed revisions to the Lead and Copper Rule (LCR), focusing on changes that EPA should to make to the:

  • Definition of a lead service line (LSL);
  • Requirements for water systems to develop LSL inventories; and
  • Notification of individual consumers who drink water that passes through an LSL.

We highlighted strengths and weaknesses of the LCR in a blog earlier this week, and we encourage states and communities to consider adopting the positive provisions now in addition to the changes we ask EPA to adopt in these comments. Below is a summary of our comments on these three issues. We plan to address other issues on the proposed revisions to the LCR in later comments.

Lead Service Line Definition

EPA’s proposed change to the current definition of an LSL at 40 CFR § 141.2 is flawed because it continues to exempt goosenecks, pigtails, or other connectors made of lead. These connectors are a major source of lead in drinking water not just because they are made of lead, but because they can release significant amounts of lead particulate into water as they flex with temperature, are scoured by turbulent water flow, and as other conditions change.

The exemption of these connectors from the definition of an LSL would render a water system’s LSL inventory and periodic notices to customers misleading because service lines described as “non-lead” may actually have some lead pipe in them. This will give residents a false sense of security. We recommend that the agency modify the proposed definition by deleting the exemption and explicitly stating that goosenecks, pigtails and connectors made of lead are LSLs.

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