EDF Health

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

By / Published: April 25, 2018

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 »

Also posted in Air pollution, Health science, Industry influence, Regulation / Tagged , | Comments are closed

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

By / Published: April 23, 2018

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 »

Also posted in 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

By / Published: April 19, 2018

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.

Also posted in TSCA reform / Tagged , , | Comments are closed

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

By EDF Blogs / Published: April 17, 2018

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.

 

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EDF comments fault EPA for deviating from the law in proposal for states and health professionals’ CBI access

By / Published: April 17, 2018

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

One of the key reforms to the Toxic Substances Control Act (TSCA) made by 2016’s Lautenberg Act was the expansion of who can access confidential business information (CBI) submitted by companies to EPA.  The old law largely limited access to federal government employees and contractors.  Congress recognized the enormous value such information could provide to officials at other levels of government and to health providers and environmental officials treating or responding to chemical releases and exposures.  It therefore mandated that EPA expand CBI access, subject to certain conditions specified in the law.

In March, a full 21 months after passage of the Lautenberg Act, EPA finally issued draft guidance documents setting forth how it intends to meet the law’s mandate to expand access to CBI.  Unfortunately, as has been the case with so many other aspects of TSCA implementation under the Trump administration, EPA got a lot of things wrong in its draft guidance documents.

Yesterday, EDF filed extensive comments raising our concerns over these serious deviations from the law and providing our recommendations for fixing them.   Read More »

Also posted in Public health, TSCA reform / Tagged , , | Comments are closed

Heavy metals in food: Carrageenan as an example of the need to improve ingredient quality

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 6, 2018

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

[pullquote]

Arsenic, cadmium and lead levels in carrageenan varied widely but were within international standards. This is not reassuring since current specifications for the heavy metals are inadequate. Food manufacturers can and should set tighter limits to better protect their customers. Consumers, especially those buying from internet-only retailers, need to ask the ingredient supplier how much of the heavy metals is acceptable.

[/pullquote]

In the fall of 2013, the Food and Drug Administration (FDA) bought 10 samples of carrageenan from 5 companies sold through internet-only retailers to test for three heavy metals – lead, arsenic (total and inorganic), and cadmium. The agency published the results on its combination metals testing webpage in September 2016.

Each of these metals are carcinogens. In addition, lead and inorganic arsenic are widely acknowledged as harming children’s brain development even at low levels of exposure. EDF found that more than one million children consume lead in amounts that exceeds the maximum exposure level set by FDA in 1993, a level that subsequent research shows is of great risk to children’s health. Further, recent research has strengthened evidence of the relationship between low levels of lead exposure in adults and cardiovascular deaths. In 2011, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) took the extraordinary step of withdrawing its previous tolerable intake level for lead because it could not determine a safe level of exposure for children.

In light of these risks, we must make every effort to reduce the levels of these heavy metals in food to the greatest extent possible – without undermining other food safety measures or compromising quality. A key step to success is examining the levels of heavy metals in all ingredients used to make a food since the risk is based on the cumulative exposure – even if the amounts in individual additives are small. With this in mind, we revisited FDA’s analysis of carrageenan.

Read More »

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