EDF Health

EPA IRIS program receives high marks from the National Academies

Jennifer McPartland, Ph.D., is a Senior Scientist and Ryan O’Connell is a High Meadows Fellow with the Health Program.

Last week the National Academy of Sciences (NAS) published its review of the Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) program, concluding that the program has made strong progress in implementing NAS’ earlier recommendations. As noted by the chair of the NAS committee that led the review, “The changes in the IRIS program over such a short period of time are impressive.”

As I’ve blogged about before, IRIS is a non-regulatory program that provides critical chemical reviews and scientific expertise that help ensure the water we drink, the air we breathe, and the land where we live, work, and play are safe. Offices across EPA and elsewhere in the federal government rely on IRIS, as do states, local governments, and affected communities (see here and here).

“The changes in the IRIS program over such a short period of time are impressive.”

The new NAS report comes four years after its 2014 review, which noted the substantial progress made by IRIS in addressing recommendations from a more critical 2011 review of a draft IRIS assessment of formaldehyde. It is worth noting that half of the committee members involved in the new IRIS review served on the committee that authored the 2011 review.   Read More »

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Too little, too fast: EDF comments raise numerous concerns with EPA’s proposal to expand use of a toxic chemical

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

Last month EDF blogged about  our request to the Environmental Protection Agency (EPA) to extend the illegally and unreasonably short 15-day comment period it had provided on a modification EPA is proposing to make to expand the ways a toxic chemical could be used, subject to certain conditions, without triggering any requirement to first notify EPA.  Specifically, EPA is proposing to modify the Significant New Use Rule (SNUR) applicable to the chemical – which currently limits its use to metalworking fluid – to allow the chemical also to be used as an anti-corrosive agent in in oilfield operations and hydraulic fluids.

Our request  also noted that EPA had failed to provide the public with anything approaching a complete set of documents relevant to its proposal.  For example, the public docket for the proposed modified SNUR lacked even a redacted copy of the Significant New Use Notice (SNUN) that triggered EPA’s consideration of the expanded use.

EPA’s proposal to amend the SNUR noted that, while EPA was expanding the allowable uses of the chemical, it was also proposing to impose additional conditions on the use.  These conditions were necessary, EPA argued, because of “test data on the substance and on new data regarding the expected release of formaldehyde from the substance, for skin and eye irritation, neurotoxicity, mutagenicity, oncogenicity, allergic responses, and developmental toxicity.”

Yet the docket did not include copies of these health and safety studies or the test data, despite being referred to in the proposal and in other documents that are in the docket.  As a reminder, such health and safety studies and their underlying data must be made public under the Toxic Substances Control Act (TSCA).  And of course, access to them is crucial if the public is expected to comment on EPA’s proposal.

A few days before the end of the 15-day comment period, EPA did grant a 17-day extension.  It also added a copy of the SNUN to the docket.  But it failed to add any of the health and safety studies or associated data we had identified as missing.

The comment period ended yesterday, and despite the serious time constraint and information gaps, EDF filed these extensive comments last night.  In preparing our comments, however, we found that the amount of health and safety data EPA had failed to provide is even greater than we had originally thought.  And our concerns over the adequacy of EPA’s review of this new proposed use and of the conditions it proposes to include in the modified SNUR have only grown.   Read More »

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

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.

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.

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 »

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

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.

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.

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.

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Major Strides: Walmart Details Progress on Chemicals

Boma Brown-West is a Manager, Consumer Health Corporate Partnerships Program and Jennifer McPartland, Ph.D., is a Senior Scientist with the Health Program

In 2013, Walmart published its Sustainable Chemistry Policy, which focuses on ingredient transparency and advancing safer product formulations in household and personal care products. EDF worked with Walmart as it developed its policy and has advised the company during implementation and data analysis.

This past April, Walmart announced that the company achieved a 95% reduction by weight in the use of high priority chemicals of concern. Today, Walmart shared considerable additional information detailing the progress made, including the identities of the initial high priority chemicals. Let’s unpack this.

Read More »

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EPA identifies another risky chemical: Can it succeed in using TSCA to restrict it?

Lindsay McCormick is a Research Analyst.

Last week, EPA released a risk assessment on the chemical N-Methylpyrrolidone (NMP).  NMP is produced and imported into the U.S. in huge quantities (184 million pounds reported in 2012), and has a variety of uses including petrochemical processing, making plastics, and paint stripping.

Experiments in laboratory animals demonstrate that exposure to NMP during pregnancy leads to adverse developmental outcomes in the offspring, such as low birth weight, skeletal malformations, and mortality (see here and here).

EPA’s assessment focused exclusively on NMP exposure from its presence in products used to remove paint and other coatings.  Because of NMP’s potential to disrupt fetal development, EPA assessed exposures in women of childbearing age.

EPA found that exposure to NMP-based paint strippers in women of childbearing age beyond four hours per day presents risks that cannot be mitigated from use of protective gear such as gloves and respirators.  Risks obviously could be greater, even for shorter exposure times, if protective equipment is not consistently used.   Read More »

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