EDF Health

The Trump EPA’s first TSCA risk evaluation is an epic fail

By / Published: January 15, 2019

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

Yesterday Environmental Defense Fund (EDF) filed more than 100 pages of comments on a 40-page draft risk evaluation the Trump Administration’s Environmental Protection Agency (EPA) has prepared for Pigment Violet 29 (PV29).  PV29 is the first of 10 chemicals undergoing risk evaluations under the Toxic Substances Control Act (TSCA).  Our comments were so much longer than the EPA document we were commenting on because there was far more to say about what information EPA failed to obtain, make available or consider than what EPA included in its draft.

The essence of our lengthy comments can be boiled down to a single sentence, however:  EPA has utterly failed to demonstrate that PV29 does not present unreasonable risk of injury to health or the environment.

For folks who want somewhat more detail than this, our comments start with a 4-page Executive Summary that capsulizes the many serious deficiencies we identified in EPA’s draft.  I’ll provide some highlights in this post.   Read More »

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FDA is dragging its feet while children continue to be exposed to perchlorate in food

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: January 11, 2019

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

It has been more than 18 months since EDF and other advocates challenged the Food and Drug Administration’s (FDA) May 2017 decision to continue allowing perchlorate in dry food plastic packaging and food handling equipment.

While Congress gives FDA 180 days to act on food additive petitions, FDA must act “as soon as possible” on a challenge such as ours. However, the agency has yet to complete a review of its May 2017 decision in light of our concerns and evaluate whether to either stand by it, or reverse it. We did not expect FDA would take three times longer to review a decision already made, especially since our objection is largely based on the agency’s own data.

In the meantime, perchlorate in food continues to threaten children’s brains. The chemical, a component of rocket fuel, disrupts the thyroid gland’s normal function and reduces production of the thyroid hormone needed for healthy fetal and child brain development. FDA’s own studies show increased levels of perchlorate in foods such as baby food dry cereal, indicating the chemical’s intentional use in dry food packaging is the likely source of increased exposure for young children.

How FDA got it wrong

In FDA’s May 2017 decision to continue allowing intentional use of perchlorate in contact with dry food, the agency largely relied on flawed science to assess dietary exposure. Its three central errors were:

  1. Ignoring its own data showing significantly increased exposure for children;
  2. Woefully underestimating exposure based on a flawed migration test; and
  3. Unrealistically assuming that perchlorate-laden plastic would only contact food once.

Read More »

Also posted in FDA, Food, Health policy, Perchlorate, Public health / Tagged , , | Comments are closed

The Trump EPA’s first risk evaluation under the new TSCA is a house of cards

By / Published: December 19, 2018

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

I’ve been blogging about the deep problems surrounding the first draft risk evaluation the Trump Administration’s Environmental Protection Agency (EPA) has released under the recently amended Toxic Substances Control Act (TSCA).  This risk evaluation, which is now out for public comment, is on a chemical commonly called Pigment Violet 29, or PV29.  Among the many problems that immediately jumped out as we began our review of this draft evaluation are EPA’s reliance on clearly inadequate health and environmental hazard data to conclude the chemical is safe, as well as EPA’s illegal withholding from the public of the little hazard information it does have.[pullquote]I suppose if you start with almost no reliable data on a chemical, are dead set against using your enhanced authorities to get any more data, and are hell-bent on finding the chemical is safe, this is how you might choose to conduct a risk evaluation.[/pullquote]

This post will look at the other half of the risk equation, exposure.  EPA has even less information on exposures to PV29 than it does on hazard.  EPA has no actual data on the levels of PV29 released to or present in air, soil, sediment, surface water, people, other organisms, workplaces or products containing or made from the chemical.  It lacks any data from, and hasn’t used its authorities to require, monitoring in workplaces or any environmental media.

So what does EPA have?   Read More »

Also posted in Health policy, Industry influence, Regulation, TSCA reform / Tagged , , , | Comments are closed

Exhibit PV29: Why this EPA can’t be trusted to forthrightly assess chemical risks under TSCA

By / Published: December 13, 2018

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

I blogged last week about the Environmental Protection Agency’s (EPA) illegal and hypocritical decision to deny the public access to health and safety studies conducted on the first chemical to undergo a risk evaluation under the reformed Toxic Substances Control Act (TSCA).  In its draft risk evaluation, now out for public comment, EPA relied on these secret studies to assert that the chemical, commonly known as Pigment Violet 29, or PV29, is safe, so EPA’s denial of public access matters a great deal.

EPA asserts that these studies are entitled to protection as confidential business information (CBI) under TSCA, when in fact TSCA explicitly does not extend CBI protection to such studies.  The only health and environmental information on this chemical that is public are brief summaries of those studies that were prepared by the companies that make the chemical, and were submitted to the European Chemicals Agency (ECHA) when the chemical was registered under the European Union’s REACH Regulation.  (EPA erroneously states that the studies were “summarized by ECHA.”  This is simply not the case:  Registrants, not ECHA, develop the summaries that are then made available in the registration “dossiers” for REACH chemicals.)

As we review EPA’s draft risk evaluation for PV29, we are finding that EPA’s assertions cannot be trusted even about what these summaries state are the findings of the underlying studies.  I’ll discuss one such case in this post.   Read More »

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: October 25, 2018

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.”

Read More »

Also posted in FDA, Food, Health policy, Lead, Public health, Regulation / Tagged , , , | Authors: / Comments are closed

EDF files extensive comments critical of EPA’s problem formulations for the first 10 chemicals being reviewed under TSCA

By / Published: August 17, 2018

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

Last night, Environmental Defense Fund (EDF) submitted more than 200 pages of comments providing a detailed critique of each of the “problem formulations” EPA issued in June for the first 10 chemicals in commerce undergoing risk evaluations under the Toxic Substances Control Act (TSCA).  EDF also delivered 45,000 comments to EPA from members of the public across the country echoing our concerns.

The EPA documents lay out the scope of each of the risk evaluations EPA will conduct.  They are highly flawed and deviate in numerous ways both from what TSCA requires and from use of the best available science.   Read More »

Also posted in Health policy, TSCA reform / Tagged , , | Comments are closed