EDF Health

FDA-approved PFAS: A serious breakdown in assessing food additive safety

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

This blog is the fourth in a series describing information we discovered in reviewing thousands of pages from the Food and Drug Administration’s (FDA) response to our Freedom of Information Act (FOIA) of the agency’s approval of 31 Food Contact Substance Notifications (FCNs) from 2002 to 2016 submitted by six companies for 19 distinct chemical mixtures of per- and poly-fluorinated substances (PFAS).

In this blog, we identify one company’s serious breach of its obligation to provide FDA with all relevant toxicology data. While hindsight is 20/20, we have reason to believe that if FDA had had all relevant information, it would have demanded more studies potentially revealing risks that are only now coming to light with related chemicals. Though we have not completed a similar review for the other companies, we think this inadequate approach to chemical safety is not unique to a single company, and FDA should reassess all its reviews given what is now known about PFAS chemicals.

Safety assessment requirements for food additives – including food contact substances

When a company seeks FDA’s approval of food additives (including food contact substances), it is required to provide the agency with all relevant chemistry, toxicology and environmental data so it can conduct a safety assessment. While the agency typically conducts a literature search of its own and of public databases, the company that is claiming the chemical’s use is safe is obligated to include any data that is inconsistent with the company’s conclusion.

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Also posted in Drinking Water, EPA, FDA, Food, Health Policy, PFAS, Public Health / Tagged , , , , | Read 1 Response

Need more evidence of the chemical industry’s bad faith on TSCA? Read this.

Richard Denison, Ph.D.is a Lead Senior Scientist.  Stephanie Schwarz, J.D., is a Legal Fellow.

This story is about chemicals known as chlorinated paraffins.  They are used as flame retardants, plasticizers and lubricants, among other things.  They come in three main versions:  short, medium, and long-chain.  Short-chain chlorinated paraffins (SCCPs) have been banned or are set to be banned in a number of jurisdictions and are listed for elimination under the Stockholm Convention.  The U.S. is not a party to Stockholm and has not banned SCCPs.  However, in 2012 EPA secured agreement from their leading domestic manufacturer, Dover Chemical Corporation, and their leading importer, INOVYN (formerly INEOS Chlor Americas, Inc.), to phase them out in consent decrees issued to settle enforcement actions EPA had brought against the companies (more on that later).

Concern over the medium and long-chain variants (MCCPs and LCCPs) has been significant and growing, however.  This is because they, like SCCPs, are expected to be very persistent and very bioaccumulative (vPvB) and, given evidence of systemic toxicity as well as toxicity to aquatic and terrestrial organisms, are also expected to be PBTs (persistent, bioaccumulative, and toxic chemicals).

The regulatory history of chlorinated paraffins under TSCA has been long and taken numerous, often troubling, turns.  We’ll only touch on some highlights here.   Read More »

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FDA reduces maximum daily limit for lead in children’s food by half

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

On September 27, 2018, the Food and Drug Administration (FDA) reduced the maximum allowed daily intake of lead for children from 6 to 3 micrograms per day (µg/day). It has also set a limit for adults of 12.5 µg/day, to protect against possible fetal exposure in women who are unaware they are pregnant and to reduce infant exposure during nursing. The agency now refers to these limits as the “Interim Reference Level” to match the Centers for Disease Control and Prevention’s (CDC) terminology for elevated blood lead levels that warrant action. FDA reports that the new level for children is the amount of lead in food expected to result in a blood lead level of 5 µg/deciliter, with a 10-fold safety factor to account for differences across the population.

This change is a major step in FDA’s new push to limit heavy metals in food to protect children’s neurological development. In April 2018, FDA explained that its Toxic Elements Working Group is “looking at all the [heavy] metals across all foods rather than one contaminant, one food at a time,” and that “even though the level of a metal in any particular food is low, our overall exposure adds up because many of the foods we eat contain them in small amounts.”

As the agency indicated earlier this year, the next step for the Working Group is to “begin reevaluating the specific lead levels that FDA has set for a variety of foods.”

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One click away: We discovered just how easy it still is to purchase deadly paint strippers

Sam Lovell, Project Specialist, and Andrew ReaganCampaign Project Manager.

Methylene chloride is a deadly chemical used in common paint stripping products. It is known to have caused over 50 deaths from acute exposure – though many more likely have gone unreported. Health impacts from lower-level, chronic exposure to the chemical through use of these products, while much harder to measure, have no doubt occurred as well. Due to its health risks, the EPA proposed a rule to ban consumer and most commercial uses of the chemical in paint and coating removal products on January 12, 2017. Over a year and a half later, the ban on methylene chloride in paint strippers still has not been finalized.

As the current Administration continues to delay action on this critical ban, some companies have stepped up and committed to take paint strippers containing methylene chloride off their shelves. Unfortunately, this isn’t enough to protect all consumers or workers. We found out that it’s still shockingly easy to buy products containing the chemical from other companies – it’s a simple click away.

To figure out just how easy it is, we searched for “paint stripper” and “paint remover” on Amazon. On the first page of our search results were several products containing methylene chloride. (This information is not at all obvious to consumers – you need to read the fine print on the product description.)

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EPA Updates its 3Ts Guidance for Reducing Lead in Drinking Water

Lindsay McCormick, is a Project Manager. Tom Neltner, J.D., is the Chemicals Policy Director.

Earlier this month, EPA released its updated 3Ts for Reducing Lead in Drinking Water Toolkit, which provides guidance for schools and child care facilities seeking to ensure children are safe from lead in water.  The new 3Ts – an update to the agency’s 2006 guidance – is now a web-based toolkit that includes modules, customizable templates, and factsheets.

Overall, the new toolkit is an improvement.  While the protocol itself is largely the same, the new toolkit is more user friendly and written for the non-technical audience, making it more likely that school and child care staff will use it.  EPA has also reframed the toolkit from “Training, Testing, and Telling” to “Training, Testing, and Taking Action” – placing more emphasis on the critical step of addressing lead sources than the previous version.  “Telling” is now integrated throughout the entire toolkit to highlight the importance of communication at every step. The agency has also developed a helpful flushing best practices factsheet, which is a topic that often causes considerable confusion.

In EDF’s June 2018 report on our pilot of 11 child care facilities, “Tackling lead in water at child care facilities,” we recommended EPA update its 2006 guidance to address four key gaps.  The agency has made progress on the two most important of those but leaves the other two unresolved. The most important change to the guidance is that the agency has removed the 20 parts per billion (ppb) action level and instead recommends action whenever there are “elevated lead levels.” While EPA does not define an elevated lead level, a deep dive into the appendix suggests that levels over 5 ppb warrant follow-up. The updated guidance also puts a greater emphasis on the identification of lead service lines (LSLs) and includes LSL replacement as a permanent control measure, though not as an explicit recommendation. Further, the agency did not update the protocol to deal with challenges posed by aerator cleaning and hot water heaters.  Below we explore each of these issues in further detail. Read More »

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EPA needs to get its SNURs in order under TSCA

Stephanie Schwarz, J.D., is a Legal Fellow.  Richard Denison, Ph.D.is a Lead Senior Scientist.

On Friday EDF submitted comments to EPA on a batch of Significant New Use Rules (SNURs) the Environmental Protection Agency (EPA) published on August 1 pursuant to the Toxic Substances Control Act (TSCA).

The SNURs relate to 145 new chemicals for which EPA had earlier issued consent orders that imposed certain conditions on the substances.  Those consent orders date back to when EPA was still pursuing the development of such orders for many new chemicals it reviewed, and prior to the recent “pivots” it has been making in an effort to avoid issuing orders by circumventing the requirements of the TSCA provisions governing new chemicals.

TSCA anticipates that EPA will promulgate SNURs to follow up on consent orders.  In fact, TSCA section 5(f)(4) requires that when EPA issues an order, EPA must either promulgate a SNUR or provide a statement explaining why EPA is not doing so.  And when EPA does promulgate such a SNUR, the SNUR must “identif[y] as a significant new use any manufacturing, processing, use, distribution in commerce, or disposal of the chemical substance that does not conform to the restrictions imposed by the … order.”

EDF strongly supports EPA’s use of SNURs to follow up on consent orders it issues.  That is because the order only applies to the original company that submitted a premanufacture notice (PMN) to EPA for a new chemical.  A proper SNUR then requires that company or any other company that seeks to deviate from the conditions in the order to first notify EPA, triggering a review of that “significant new use.”

While EDF supports EPA’s issuance of SNURs for these 145 new chemicals, our review of the proposed SNURs raised concerns, prompting us to file “adverse” comments.  Our comments raise two major concerns:

First, EPA has adopted an ad hoc testing policy in the direct final rule that does not comply with the requirements of TSCA, without sufficient explanation, and without providing any notice and opportunity for public comment on the policy. EPA needs to avoid adopting such an ad hoc policy.

Second, as noted above, TSCA (as well as EPA’s longstanding policy) requires SNURs to “conform” to the restrictions in the corresponding orders.  Yet we identified numerous inconsistencies between the orders and SNURs.  EPA must ensure that the final SNURs identify as a significant new use any activity that is not consistent with the restrictions in the corresponding consent orders.

See our comments for details.

NOTE:  EPA had published the SNURs both as a direct final rule and as a proposed rule, noting that if it received any adverse comments, it would withdraw the direct final rule and consider the comments received in the process of finalizing the proposed rule.  We expect EPA will now pursue this course.

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