EDF Health

Challenge to FDA’s GRAS rule moves forward after court rejects request for dismissal

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 14, 2018

Tom Neltner, J.D., is Chemicals Policy Director

In a critical ruling for food additive safety, a federal district court ruled on Wednesday that EDF, represented by Earthjustice, has standing in its legal challenge to the Food and Drug Administration’s (FDA) Generally Recognized as Safe (GRAS) rule. This 2016 final rule allows food manufacturers to make secret GRAS safety determinations for chemicals added to food, without notifying FDA or the public, and to use the chemical in food without anyone else’s knowledge. The court was considering a motion to dismiss from FDA arguing that plaintiffs did not have standing to bring the case. The judge found EDF and the Center for Food Safety (CFS) “plausibly allege harm to their members” and therefore “satisfy the injury-in-fact requirement for standing.” Our legal challenge now moves to the substance of our concerns with the flaws in the agency’s GRAS Rule.

The court found that members of EDF and CFS showed a risk of harm consistent with the requirements of the law in alleging that FDA’s “GRAS Rule poses a credible threat to their members.” Specifically the court stated that:

  • Their members “have been and will be exposed to potentially dangerous substances that were introduced into the food supply without FDA oversight, public participation, or the opportunity for judicial review.”
  • They “explicitly identify multiple substances that manufacturers determined to be GRAS and used in food despite concerns raised by FDA about their safety, as well as additional undisputedly dangerous substances that Plaintiffs reasonably anticipate will be introduced into the food supply under the GRAS Rule.”
  • “[T]hese injuries are ongoing and imminent.

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Posted in FDA, Food, Health policy, Public health / Tagged , , , , | Authors: / Comments are closed

EPA needs to get its SNURs in order under TSCA

By / Published: September 4, 2018

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.

Posted in Health policy, Regulation, TSCA reform / Tagged , , | Comments are closed

What a new head of EPA’s TSCA office will face and need to do

By / Published: August 31, 2018

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

News reports today indicate that the President is nominating Alexandra Dapolito Dunn for Assistant Administrator of EPA’s Office of Chemical Safety and Pollution Prevention, which implements the Toxic Substances Control Act (TSCA).

Here is our first take on what she will be facing and need to do, if confirmed:

The major reforms Congress made to TSCA in 2016 passed with strong bipartisan support because they struck a careful balance among competing interests.  Since that time, however, every aspect of the law’s implementation by the Trump Administration has gone badly off the rails, skewed heavily in the chemical industry’s favor at the expense of the public’s health.

In EDF’s view, any credible nominee for the OCSPP Assistant Administrator needs to understand and acknowledge this stark imbalance and take steps to address it.  The AA should be able and willing to facilitate a fundamental shift in TSCA implementation back to a course that comports with the law, reflects strong science, and is protective of public and worker health, including that of vulnerable subpopulations.

If she is confirmed, Ms. Dunn will have her work cut out for her, given the forces arrayed within and outside the agency that have led to the current imbalance.  That is a challenge that will need to be faced head-on.

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

Walmart joins ranks of retailers pulling toxic paint strippers from shelves – when will EPA follow suit?

By Sarah Vogel / Published: August 20, 2018

Sarah Vogel, Ph.D., is Vice-President for Health.

Today, Walmart announced that it will stop selling paint strippers containing methylene chloride or N-methylpyrrolidone (NMP) in stores by February 2019 – making it the first general merchandise retailer to take such action.  Walmart’s announcement follows the strong leadership demonstrated by Lowes, Home Depot, and Sherwin Williams, all of which have committed not to sell methylene chloride- and NMP-based paint stripping products by the end of the year.  Importantly, Walmart’s action goes beyond its U.S. stores, including those in Mexico, Canada, and Central America, as well as their online store.

The announcement signals an important step by Walmart to better protect consumers from dangerous paint strippers. Methylene chloride is highly neurotoxic and acutely lethal. The chemical is responsible for over 50 reported deaths from acute exposure over the last 35 years – though many more likely have gone unreported. NMP is linked to fetal development problems, including low birth weight and birth defects.

EDF has advocated for several years for the Environmental Protection Agency (EPA) to ban both methylene chloride- and NMP-based paint strippers, using its enhanced authority under the reformed Toxic Substance Control Act.  In January 2017, EPA proposed to ban methylene chloride and restrict NMP in paint strippers, but action has stalled under the Trump Administration.  For over a year, the agency made no effort to finalize these actions – even taking steps to delay any progress.

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Posted in Health policy, Markets and Retail, Public health, Regulation, TSCA reform / Tagged , , , , , , | Read 1 Response

EDF submits extensive comments critical of EPA OPPT’s TSCA systematic review document

By / Published: August 17, 2018

Ryan O’Connell is a High Meadows Fellow; Jennifer McPartland, Ph.D., is a Senior Scientist.

Last night, Environmental Defense Fund (EDF) submitted critical comments on EPA’s Office of Pollution Prevention and Toxics’ (OPPT) “systematic review” document that OPPT is using to evaluate chemicals’ risks under the Toxic Substances Control Act (TSCA).

Systematic review, a hallmark of the clinical sciences, employs structured approaches to identifying, evaluating, and integrating evidence in a manner that promotes scientific rigor, consistency, transparency, objectivity, and reduction of bias.

Unfortunately, OPPT’s systematic review document deviates dramatically from the best practices in systematic review—practices developed over decades based on empirical evidence and experience in application. OPPT’s approach also significantly diverges from recent recommendations of the National Academy of Sciences (see here and here).

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Posted in Health policy, Public health, Regulation, TSCA reform / Tagged , , , | 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 »

Posted in Health policy, Health science, TSCA reform / Tagged , , | Comments are closed