EDF Health

EDF and others take FDA to court to demand action on carcinogenic flavors petition

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.

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Methylene chloride in paint strippers: A ban is the only health-protective path forward

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.   Read More »

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Testing analysis for TSCA new chemicals embraced by EPA’s Beck has serious omissions

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:

  • First, the PETA/PCRM analysis erroneously understated the extent of testing EPA required prior to the passage of the Lautenberg Act, because it failed to count any of the testing requirements for two-thirds of the new chemicals it examined for which EPA issued consent orders in 2015 and 2016.
  • Additional context is required when assessing the extent of testing of new chemicals EPA was mandating under the new TSCA, which was not provided in the PETA/PCRM analysis.

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Critical “blanks” in EPA’s methylene chloride announcement need to be filled in if it is to be health-protective

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:

  • Ban distribution in commerce and use of methylene chloride for paint and coating removal
  • Extend to both consumer and commercial uses to ensure that workers are also protected
  • Not provide exemptions based on training, labeling or use of protective equipment
  • Be finalized and implemented quickly
  • Require full compliance within as short as possible a period

 

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EPA reaffirms Lead-Safe Renovation, Repair, and Painting Rule, citing 150% to 500% payback

Tom Neltner, J.D.is Chemicals Policy Director

In April 2018, the Environmental Protection Agency (EPA) completed a thorough review of its Lead-Safe Renovation, Repair, and Painting Rule (RRP) promulgated a decade ago. This rule requires contractors and landlords to use lead-safe work practices when more than minor amounts of lead-based paint in homes built before 1978 are disturbed. It also applies to pre-1978 child-occupied facilities. This review was conducted pursuant to Section 610 of the Regulatory Flexibility Act because of RRP’s significant impact on more than 300,000 small businesses that perform more than 4 million affected projects each year.

EPA concluded that RRP, including several post-2008 amendments, “should remain unchanged without any actions to amend or rescind it.” As part of the review, the agency updated its economic analysis and found that the estimated annual societal benefits, primarily in improved children’s IQ, of $1.5 to $5 billion exceeds the $1 billion in estimated annual compliance costs. Those estimates translate into an impressive annual payback of 150% to 500%. Keep in mind that these benefits do not include the lower risk of premature cardiovascular deaths attributed to adult lead exposure in a March 2018 report in Lancet.

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Encouraging EPA Response to Families on Deadly Paint Stripping Chemical

This statement is attributable to Dr. Sarah Vogel, Vice President for Health, Environmental Defense Fund:

“On Tuesday, Wendy Hartley and Cindy Wynne – both of whom lost their sons to methylene chloride exposure – met with members of Congress and EPA Administrator Scott Pruitt, asking that use of this deadly chemical in paint and coating removal products be banned.

We are encouraged that today EPA has decided to reverse course and move forward to finalize its proposed rule banning methylene chloride in these products.  We are also encouraged that EPA is not re-evaluating the paint stripping uses of methylene chloride and is relying on its previous risk assessments, which found very high risks to consumers and workers from these products.

It needs to be noted that EPA’s statement falls short of committing to finalize a ban.  It is vitally important that EPA move quickly to implement a ban, and that includes ensuring necessary administrative procedures are followed to guarantee a permanent ban and that these products are promptly removed from store shelves. We and families across this country will be watching closely to make sure this Administration actually delivers on today’s promise from Administrator Pruitt.

The credit for any step forward here belongs entirely to the brave members of the Hartley, Wynne and Atkins families who, to honor their sons and protect all of us, fought to ban this deadly chemical. They received important support from Senators Graham, Carper, Scott, and Udall and Representatives Sanford, Pallone, DeGette, Tonko, and Lowey, and others.

We will delay any celebration until paint strippers containing this deadly chemical are actually off the market.  There are a number of steps that now must be taken in order to effectively finalize and implement this ban.

But if methylene chloride in paint strippers is effectively removed from the marketplace, it will be a good day for American families.”

 

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