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Richard Denison, Ph.D., is a Lead Senior Scientist. Stephanie Schwarz, J.D., is a Legal Fellow.
Yesterday EDF filed extensive comments on the Environmental Protection Agency’s (EPA) proposal for the last of the so-called “framework rules” called for under the 2016 amendments to the Toxic Substances Control Act (TSCA). This rule, once finalized, will establish the “user fees” Congress authorized EPA to collect from chemical manufacturers and processors to help defray EPA’s costs for implementing TSCA.
The 2016 Lautenberg Act amendments to TSCA greatly expanded both EPA authorities and responsibilities under TSCA. These extended to chemical testing; conducting risk reviews of new chemicals and prioritizing and conducting risk evaluations of existing chemicals; managing potential or identified risks of both new and existing chemicals; collecting, reviewing and providing access to chemical information; and reviewing confidential business information (CBI) claims asserted by companies when submitting information to EPA.
To determine the level of user fees, EPA is first required to determine its full costs to exercise these authorities and carry out these responsibilities. Fees are then to be set so as to recoup 25% of those costs or $25 million annually, whichever is lower. Separate fees are to be collected to cover EPA’s costs to conduct risk evaluations of chemicals companies request, apart from risk evaluations EPA initiates.
So it is vital that EPA fully and as accurately as possible account for its costs, and that it set fees that meet the intent and letter of the law.
Unfortunately, EPA’s proposed rule falls far short of the mark. EPA has severely underestimated its baseline program costs, both by omitting costs for some relevant activities altogether and by understating the extent or actual cost of other activities. In some cases EPA set fees at a low level based only on industry’s request that it do so or by invoking factors that are not consistent with the law. In the proposal and supporting documents, EPA has provided scant detail or conflicting information on how it calculated many of its costs, making it difficult or impossible for stakeholders to know whether EPA’s estimates are at all accurate.
As a result of these flaws, EPA has set some fees at levels below those required by TSCA and the resulting funds will not be sufficient to recoup the costs TSCA authorized EPA to defray through user fees.
This post will highlight some of the many concerns and questions we discuss in detail in the comments we have submitted. (more…)
Tom Neltner, J.D., Chemicals Policy Director, and Maricel Maffini, Ph.D., Independent Consultant
Update: See June 21, 2018 Q&A blog on PFAS at textile mills and environmental permits
Across the country, communities are grappling with how to manage contamination of drinking water by perfluorinated alkyl substances (PFASs), a class of chemicals widely used in consumer products, industrial processes, and firefighting foams. Concern over the chemicals grew with the Environmental Protection Agency’s (EPA) 2016 release of a 70 parts per trillion (ppt) drinking water health advisory for PFOA and PFOS, two common and well-studied forms of PFASs.
One challenge to effectively evaluating the potential impacts of PFASs as well as cleaning up priority sites is that there is very little information on where these chemicals are being used. Through a Freedom of Information Act (FOIA) request to FDA, EDF obtained documents previously not made public that show that paper mills using PFASs may be a significant source of contamination to water and potentially to air and compost.
In the nearly 900 documents we received from FDA, we found environmental assessments in four Food Contact Substance Notifications (FCNs) submitted in 2009-2010 by two companies, Daikin America and Chemours.[1] FDA approved each notice, allowing the companies to sell their PFASs to make paper and paperboard repel oil and grease in food packaging such as pizza boxes, sandwich wrappers, and microwave popcorn bags. All four assessments based their estimates on what they called a “typical” paper mill that produces 825 tons of PFAS-coated paper per day and discharges 26 million gallons of water per day.[2]
Tom Neltner, J.D., Chemicals Policy Director, and Maricel Maffini, Independent Consultant
FDA’s priority must be resolving safety concerns with
existing chemicals over approval of new ones.
On May 2, EDF and other consumer health advocates filed a lawsuit to force the Food and Drug Administration (FDA) to make a final decision on our food additive petition, which asked the agency to reverse its approvals of seven carcinogenic synthetic flavors. Earthjustice is representing EDF in this petition for a writ of mandamus to the court of appeals. We did not take this action lightly. However, with the statutory deadline for a decision passing more than 20 months ago, we saw little chance that FDA would act without court oversight.
Our food additive petition narrowly focused on one specific issue where the law and science were clear, and laid out our review of both the scientific literature and the law concluding that the seven chemicals were no longer safe. FDA formally accepted the petition for filing – essentially confirming it was complete – which triggered a 180-day deadline under the statute to make a final decision. That deadline passed in August 2016 without a decision by FDA.
Lindsay McCormick is a Project Manager and Richard Denison, Ph.D., is a Lead Senior Scientist.
Last week, EPA signaled it will advance a delayed rule regulating consumer and worker use of methylene chloride-based paint strippers. Numerous details of EPA’s announcement remain to be filled in, and we caution EPA to avoid approaches short of the ban that was proposed.
The record for EPA’s proposed ban is clear: Allowing such products to stay on the market based on reliance on such factors as increased labeling, protective equipment, or training requirements simply will not protect the public’s or workers’ health.
Sadly, the companies that make the chemical and paint strippers containing it are already seeking to resurrect those old arguments. (more…)
Richard Denison, Ph.D., is a Lead Senior Scientist. Ryan O’Connell, EDF High Meadows Fellow, and Stephanie Schwarz, EDF Legal Fellow, assisted in the research informing this post.
[UPDATED 5-15-18: See clarifications and a correction added in brackets below.]
As noted in a previous blog post, EDF recently filed a request for an extension of the public comment period on EPA’s draft Alternative Testing Methods Strategic Plan under the Toxic Substances Control Act (TSCA). This was due to the lack of public access to documents that Dr. Nancy Beck had prominently alluded to, without identifying, at EPA’s April 10, 2018, public meeting on the draft plan. EDF requested a 30-day extension starting once the documents were placed in the docket for the draft plan.
On April 27, EPA provided a 15-day extension after placing the documents in question into the docket. It turns out the documents (a letter and an attached spreadsheet) are from two animal welfare organizations, People for the Ethical Treatment of Animals (PETA) and Physicians Committee for Responsible Medicine (PCRM). They are not, were not submitted as, and apparently were not intended to be, comments on the draft plan, however; rather, they raise the groups’ concerns over the increase in testing of new chemicals under the new TSCA, based on an analysis they said indicates EPA more frequently included testing provisions when issuing consent orders for new chemicals after passage of the new law than it did before.
Given that the documents PETA and PCRM submitted were not comments on the draft plan and were not submitted in that context, it is all the more curious why Dr. Beck so prominently noted and expressed such enthusiasm for them at the EPA public meeting held about the draft plan – especially because it appears she did so before EPA had conducted any serious review of the documents, which as you’ll see below, is a big problem.
I suspect Dr. Beck’s interest in the PETA/PCRM letter and analysis has little to do with sparing laboratory animals and much more to do with her seeing the documents as providing a useful pretext for her concerted efforts to avoid imposing testing requirements on new chemicals – a clear priority for her previous employer, the American Chemistry Council (ACC). Industry has incentives to avoid testing due to its costs and the risks that testing may reveal a chemical presents significant risks to health or the environment.
Now that we’ve had a chance to review the PETA/PCRM documents, I want to use this post to highlight two things:
EPA’s announcement that it will move forward on its proposed rule to ban the use of methylene chloride in paint and coating removal products, while encouraging, left critical details unanswered. We look forward to EPA filling in the blanks.
EDF posted a statement earlier on the announcement here. In addition, here are five things the final rule must do to be health-protective:
