EDF Health

Paper mills as a significant source of PFAS contamination, but who’s watching?

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]

  • Chemours FCN 885 estimated 95 pounds/day of its PFAS[3] in the wastewater discharge at 43,000 ppt.
  • Chemours FCN 1027 – a notification for the same PFAS – increased the amount in paper from 0.42% to 0.8% resulting in 183 pounds per day in the wastewater discharge at 83,000 ppt.
  • Daikin FCN 933 estimated 180 pounds/day of its PFAS[4] in the wastewater discharge at 83,000 ppt.
  • Daikin FCN 1044 estimated 225 pounds/day of a similar PFAS[5] in the wastewater discharge at 103,000 ppt.

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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 2nd, 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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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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New EPA Science Regulation: A Trojan Horse that Hurts Public Health

By Dr. Ananya Roy, Sc.D. & Dr. Elena Craft, Ph.D

Last week, embattled EPA Administrator Scott Pruitt rushed to propose a new rule that may prevent EPA from using certain scientific studies in its decisions. He was in such a rush that he didn’t even wait for the White House Office of Management and Budget to complete its review of the proposal before releasing it. The rule was published yesterday in the Federal Register, marking the start of a 30 day public comment period.

Though touted as a measure for transparency, the proposed policy includes a carefully worded loophole[1] that would enable politically driven decisions on what science is used to support critical safety standards. It would hamper public health protections by allowing the agency’s political leadership to select studies that benefit its agenda and ignore those that don’t, opening the door to industry interests and secrecy.

Our colleague Richard Denison explained in a blog post last week how this policy might be used to decimate toxic chemicals safeguards at EPA. Here, we focus on what this deeply destructive proposal would mean for clean air and health.

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

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 »

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

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

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.

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.

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