Monthly Archives: April 2018

Lead in water at child care facilities: Preliminary results from EDF’s pilot

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

When choosing a child care facility, parents weigh numerous factors – like cost, distance to their home, comfort with the staff – with the goal of providing safe care to their child. Unfortunately, it’s not always easy to know if the facility where the child care program is located itself may present health risks – like lead in the drinking water.

The vast majority of schools and child care facilities are not required to test their drinking water for lead under federal requirements. While much of the attention has been on schools, we find that childcare is relatively overlooked, even though water is the most significant source of lead for formula fed infants. In earlier blogs, we talked about state and local testing requirements and levels in hot water.

[pullquote]We tested at 11 child care facilities and found lead in drinking water in at least one sample at seven facilities above our 3.8 ppb action level, three facilities above 20 ppb, and two facilities above 80 ppb.[/pullquote]

To explore lead in drinking water at child care facilities further, EDF conducted a pilot project to investigate new approaches for lead in water testing and remediation in childcare settings.  Our pilot utilized and expanded on EPA’s 3Ts for Reducing Lead in Drinking Water.

We will be releasing a report that will detail our full process, results, and recommendations for addressing lead in water in child care settings. In the meantime, we wanted to share our preliminary takeaways and recommendations below as well as a fact sheet on our project. Read More »

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

Scott Pruitt seeks to cook the books on EPA risk assessment science

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

EPA Administrator Scott Pruitt unveiled his “secret science” initiative yesterday at a press conference to which no press were invited.  While EPA has yet to post the proposed rule or otherwise make it available to the public, it was made available by others.  The main thrust of the proposal is actually considerably different and, at least initially, more targeted, than advertised by Pruitt in recent weeks and by the House of Representatives Science Committee’s Chairman Lamar Smith (R-TX), who authored the secret science legislation on which Pruitt’s proposal was to be based and appeared with Pruitt yesterday.

Yesterday both men stuck to their earlier talking points about the need to make sure all information EPA relies on is reproducible and fully publicly available, and never mentioned the change in the focus of the proposal.  I suspect both of them would have been hard pressed to describe the actual main focus of the proposal, which is now this:

When promulgating significant regulatory actions, the Agency shall ensure that dose response data and models underlying pivotal regulatory science are publicly available in a manner sufficient for independent validation.  (p. 23, emphases in original)

But I am sure Dr. Nancy Beck, chemical industry toxicologist turned top political appointee in EPA’s toxics office, could in a heartbeat.

I would describe the new approach, while no less dangerous, as a laser-guided missile in comparison to the carpet-bombing approach taken by the House legislation and earlier iterations of the EPA proposal.   Read More »

Posted in Air pollution, Health policy, Health science, Industry influence, Regulation / Tagged , | Comments are closed

FDA details its new push on heavy metals in food

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

In May 2017, the US Food and Drug Administration (FDA) Center for Food Safety and Nutrition (CFSAN) announced it had “established a Toxic Elements Working Group whose mission in part is to develop a strategy for prioritizing and modernizing the Center’s activities with respect to food/toxic element combinations using a risk-based approach.” FDA set a goal of limiting lead “to the greatest extent feasible.”

In April 2018, FDA released an interview with the Working Group’s chair, Conrad Choiniere, providing an update on its activities. An overarching point expressed by Choiniere during the interview is that “these metals [lead, arsenic, cadmium and mercury] can have effects on children’s neurological development.” This affirmation of scientific evidence is a welcome sign from the agency. FDA’s key statements are:

  • Initial scope: Children’s exposure to “metals like lead, arsenic, cadmium, and mercury in foods, cosmetics, and dietary supplements.”
  • Approach: “Looking at all the metals across all foods rather than one contaminant, one food at a time.”
  • Initial findings: “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.”
  • Next steps:
    • “Finalizing the draft guidance that sets an action-level for the presence of inorganic arsenic in infant rice cereals and apple juice.”
    • “Begin reevaluating the specific lead levels that FDA has set for a variety of foods.”

Read More »

Posted in FDA, Food, Lead, Public health / Tagged , , , , | Comments are closed

EPA practices are hindering transparency and public confidence in TSCA’s new chemicals program

Stephanie Schwarz, J.D., is a Legal Fellow.  Richard Denison, Ph.D., is a Lead Senior Scientist.

Part 1               Part 2               Part 3               Part 4

This is our final post in a series spurred by our review of 69 public files for new chemicals we received from EPA’s Docket Center.  For most of these chemicals, EPA made a determination that they are “not likely to present unreasonable risk” under the Toxic Substances Control Act (TSCA), which greenlights their entry into commercial production.

In our previous post we demonstrated EPA is not complying with a number of provisions under TSCA that require the agency to make public the premanufacture notices (PMNs), notices of commencement (NOCs), and information that is submitted with them.  In this post we look further into how, through these failures and others, EPA has impeded meaningful transparency in the new chemicals program.

As originally enacted in 1976, TSCA recognized the value of public access to information, like health and safety information (see, e.g., TSCA § 14(b)).  Even in EPA’s original (1983) regulations establishing the new chemicals review program, EPA recognized that “[p]ublic participation cannot be effective unless meaningful information is made available to the interested persons” (see here p. 21737).  Among the many flaws of the original TSCA, however, was the law’s inability to ensure EPA delivered the promised transparency when it came to both information EPA receives and the agency’s decisions on new chemicals.

The amendments to TSCA in 2016 were meant, in part, to expand public access to information about both chemicals and agency decisions, and in doing so increase public confidence.  For instance, under § 26, EPA must now make available to the public “all notices, determinations, findings, rules, consent agreements, and orders.”  And under § 5, EPA must now make an affirmative determination on new chemicals, which under § 26 must be made public.  These changes, in addition to the original TSCA provisions, clearly envision a robust program under which the public is able to readily access non-confidential information on new chemicals and information on EPA’s decisions about them.  [pullquote]Coupled with the policy changes EPA has made, the concerns we raise here make clear that EPA under this Administration intends to weaken a new chemicals program that Congress sought to strengthen through TSCA reform – and hide as much of it from public view as possible.[/pullquote]

As implemented, however, a number of features of the new chemicals program severely hamper the ability of the public to understand EPA’s decision-making or engage in the new chemicals program.  In addition to the failings we have discussed in previous posts in this series, this post will address several others:

  • the convoluted and fragmented public information “system” EPA has created for PMNs;
  • the failure of EPA to provide access to agency-generated health and safety information on PMN substances; and
  • EPA’s failure to publish Notices of Commencement (NOCs) and EPA’s determinations on confidentiality claims for specific chemical identity in those NOCs.

Read More »

Posted in Health policy, TSCA reform / Tagged , , , , | Comments are closed

EDF requests extension of comment period on TSCA Alternative Testing Strategic Plan due to key document missing from docket

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

Last night EDF submitted a request to the Environmental Protection Agency (EPA) to extend the public comment period on its draft Alternative Testing Methods Strategic Plan under the Toxic Substances Control Act (TSCA).

EPA held a public meeting about the draft Strategic Plan on April 10, 2018.  At that meeting, Dr. Nancy Beck prominently highlighted an analysis that EPA had received from a stakeholder that she described as robust and extensive, and her description of the analysis suggested that it has or could significantly influence EPA’s consideration of the issues raised by the draft Strategic Plan.  When asked if EPA would make this analysis available to the public, an EPA official stated that it would be made available.  But the analysis has not yet been published to the docket.  The due date for comments on the draft Plan is a week from today, April 26, 2018.

Given the emphasis Dr. Beck placed on the analysis and the apparently extensive nature of it, EDF believes the public should be provided access to the document and ample time to review, and if desired, comment on it.  Hence we have requested that:

1)  EPA publish a copy of the relevant analysis to the docket for the draft Strategic Plan.

2)  EPA extend the public comment period by 30 days after it publishes the relevant analysis in the docket.

Because the deadline is impending, EDF requested that EPA respond to this request within three business days, i.e., by Monday, April 23.

Posted in Health policy, TSCA reform / Tagged , , | Comments are closed

EDF joins Opening Brief in legal challenge to EPA’s Prioritization and Risk Evaluation Rules

Late yesterday, EDF joined fourteen other Petitioners in filing an Opening Brief in our case challenging EPA’s Prioritization Rule and Risk Evaluation Rule.  The Brief was filed with the U.S. Court of Appeals for the Ninth Circuit.

Our Brief argues that the Toxic Substances Control Act (TSCA), as amended by the Lautenberg Act, requires EPA to comprehensively evaluate a chemical’s hazards and exposures arising from all of its “conditions of use,” a term defined under TSCA as encompassing the chemical’s entire lifecycle from manufacturing and processing to use and disposal.  EPA is then to make a holistic determination of whether the chemical presents an unreasonable risk of injury to human health or the environment, including to potentially exposed or susceptible subpopulations.  EPA’s Rules violate this requirement because EPA asserts unfettered discretion to exclude known or reasonably foreseen exposures and conditions of use from consideration, thereby ignoring potentially important contributors to a chemical’s overall risk.  As a result, the Rules threaten to leave the public—especially vulnerable groups like children, pregnant women, and workers—as well as the environment inadequately protected from the potential risks posed by the thousands of chemicals to which we are exposed every day.

EPA’s response brief in the case is due to the Court on July 5, 2018.  As this litigation proceeds, you can find more information – including all significant legal documents – on EDF’s website.

 

Posted in Health policy, TSCA reform / Tagged , , , | Comments are closed