EDF Health

Formaldehyde delay rule – another defeat for Trump EPA

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: February 20, 2018

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

March 17, 2018 update: The court ordered EPA’s rule vacated as of June 1, 2018 based on an agreement by the parties.  This rule would have delayed the compliance deadline for the formaldehyde from composite wood products rule from 12/12/17 by one year.  The parties agreed that until March 22, 2019, products certified as compliant by the California Air Resources Board is sufficient to comply with EPA’s rule. EPA has updated its webpage to provide details. The parties reserved their right to appeal the order.

On February 16, the Trump Administration’s Environmental Protection Agency (EPA) suffered another defeat in the courts.

In the latest case, the United States District Court for Northern California found that EPA violated the law when it gave industry a one-year delay to comply with formaldehyde emission standard for composite wood products. The standard was supposed to go into effect on December 12, 2017, one year after it was published in the Federal Register. Administrator Pruitt originally proposed a three month delay because, with the change in Administration, the agency failed to make a certification program essential to industry compliance operational, as originally planned. On September 25, 2017, the agency issued a final rule that gave a one-year extension instead, concluding that the delay “provides a balanced and reasoned timeline for importers, distributors, and regulated entities to establish compliant supply chain and comply with the [rule].” It also extended other deadlines in the rule.

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New study links PFAS exposure and body weight regulation

By / Published: February 20, 2018

Ryan O’Connell is a High Meadows Fellow

Perfluoroalkyl and polyfluoroalkyl substances (PFAS), sometimes referred to by the broader term “PFCs” (perfluorinated chemicals), are a large class of chemicals used to make products water- or grease-resistant. They can be found in everything from nonstick cookware and clothing to food packaging and adhesives. While PFAS have useful commercial and industrial applications, these chemicals also persist in the environment and in people, and a number of them have been shown to be very toxic.

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

No justification: Substantiations for rampant new chemical CBI claims are deficient or lacking altogether

By / Published: February 16, 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

We recently started a series of blog posts describing what we did, and did not, get from the EPA Docket Center when we requested the public files on about 70 new chemicals, most of which EPA had determined were “not likely to present an unreasonable risk” under the Toxic Substances Control Act (TSCA), as amended in 2016 by the Lautenberg Act.  To continue our series, we address in this post EPA’s pervasive failure to require companies to adequately substantiate Confidential Business Information (CBI) claims, and its own apparent failure to review such claims, despite clear requirements to do so under § 14 of TSCA. [pullquote]Twenty months after passage of the Lautenberg Act, we simply must ask:  When will EPA start carrying out its new responsibilities on CBI claims – which includes compelling companies to comply with the law?[/pullquote]

First, to provide some context, let us address a question we were asked based on our first post: whether the PMN situation we are describing is any worse now than it was pre-Lautenberg Act.  We suspect it is not necessarily worse.  However, the purpose of the reforms to CBI in the Lautenberg Act was to fix these problems, by requiring substantiation and EPA review of most CBI claims, including those asserted in premanufacture notifications (PMNs) submitted for new chemicals.  By and large it appears this is simply not happening, 20 months after the law passed and those provisions took effect.

Few of the PMN public files we received included any substantiations, despite massive assertions of CBI claims that require substantiation; instead, companies simply redacted the information.  In addition, nearly all of those submissions that do include a substantiation document are wholly inadequate, routinely claiming information as CBI that is not eligible for nondisclosure or failing to provide justification for information that may be eligible.  The violations are so egregious that they indicate EPA is failing to conduct even a cursory review of the claims and redactions.   Read More »

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EDF requests extension of illegally and unreasonably short comment period on proposed rule with incomplete docket

By / Published: February 12, 2018

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

Environmental Defense Fund (EDF) today submitted a request to the Environmental Protection Agency (EPA) to extend the mere 15-day period EPA has provided for public comments on a proposed modification to a Significant New Use Rule (SNUR).  The proposed SNUR modification was published in the Federal Register just last Thursday (February 8), and stated that comments must be received by February 23.[pullquote]EPA must comply with its own requirements and provide electronic access to a public file containing all relevant documents prior to commencing at a minimum a 30-day comment period on this proposed rule.[/pullquote]

EPA’s own regulations require EPA to provide the public with at least 30 days to comment on SNURs, see 40 CFR 721.160(c)(4) and 721.170(d)(4), making EPA’s 15-day comment period illegally short.

EDF requested that EPA provide at least 30 days for public comment – with that period to commence only after a complete public docket of relevant materials is made available by EPA.  As our request details, the docket EPA has provided for this proposed SNUR is woefully incomplete, missing even basic documents that preclude the public from being able to provide meaningful comments on the proposal.   Read More »

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

Overwhelming local support for EPA Chemical Assessment Program: Communities impacted by PFC contamination urge Congress to maintain critical program

By Sam Lovell / Published: February 8, 2018

Samantha Lovell is a Project Specialist.

Today, a letter signed by more than 100 people was submitted to the House and Senate Appropriations Committees urging Congress to protect the EPA Integrated Risk Information System (IRIS) program. The signatories come from dozens of communities across the country impacted by PFC contamination in drinking water. EPA’s IRIS program develops critical assessments of chemicals, like PFCs, that support a wide variety of decision-making from clean-up levels at contaminated sites to setting standards that ensure clean drinking water.

As we have blogged about previously, IRIS is a non-regulatory program within EPA’s science arm that produces top-tier chemical hazard assessments used across EPA program and regional offices, other federal agencies, and state and local governments to protect public health. IRIS scientists are also called on during emergency and other rapid response situations, when technical expertise is paramount and time is of the essence.

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Posted in Drinking water, Health policy, Health science, Public health / Tagged , | Comments are closed

EDF lends strong support to EPA’s IRIS Program in comments at National Academies workshop

By Jennifer McPartland / Published: February 6, 2018

Jennifer McPartland, Ph.D., is a Senior Scientist with the Health Program.

Last week the National Academies held a public workshop as part of its review of changes that have been made, or that are planned, by the U.S. EPA Integrated Risk Information System (IRIS) program. The last National Academies review, published in 2014, pointed to significant advancements the program had already achieved since its prior 2011 report:

Overall, the committee finds that substantial improvements in the IRIS process have been made, and it is clear that EPA has embraced and is acting on the recommendations in the NRC formaldehyde report. The NRC formaldehyde committee recognized that its suggested changes would take several years and an extensive effort by EPA staff to implement. Substantial progress, however, has been made in a short time, and the present committee’s recommendations should be seen as building on the progress that EPA has already made.

As I’ve blogged before, the EPA IRIS program is a non-regulatory program that provides critical information and scientific expertise that helps ensure that the water we drink, the air we breathe, and the land where we live, work, and play are safe. For example, the IRIS program has a central role to play in helping address widespread contamination of drinking water with perfluorinated chemicals.[pullquote]The American public depends on the IRIS program and it is imperative that the program remain intact, housed apart from regulatory parts of the agency, and adequately resourced.[/pullquote]

In the comments I provided on behalf of EDF at the meeting, I emphasized that the IRIS program is:

  • critical to protecting public health;
  • making significant progress toward advancing systematic review in chemicals assessment, adopting best practices from the clinical sciences in line with earlier National Academies recommendations;
  • approaching the integration of mechanistic information in chemical assessment in a scientifically sound manner;
  • making important investments in specialized software tools designed to make the development and updating of chemical assessments more efficient; and
  • appropriately and necessarily situated within the science arm of EPA where it is best positioned to conduct strong, independent science.

The IRIS program has unquestionably been responsive to earlier recommendations of the National Academies and is arguably yet again surpassing expectations. The American public depends on the IRIS program and it is imperative that the program remain intact, housed apart from regulatory parts of the agency, and adequately resourced.

A final report by the Committee is expected this spring.

Posted in Health science, Public health / Tagged , | Comments are closed