EDF Health

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

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

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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Also posted in EPA, Health Policy, Markets and Retail, Regulation, TSCA Reform / Tagged , , , , , | Read 1 Response

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

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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American Water demonstrates strong leadership on lead service line replacement

Tom Neltner, J.D.is Chemicals Policy Director

In a landmark decision on July 25, 2018, the Indiana Utility Regulatory Commission (IURC) approved American Water’s plan to fully replace the lead service lines (LSLs) in the communities served by its Indiana subsidiary over the next 10 to 24 years. This represents the replacement of about 50,000 LSLs across 27 community water systems (CWSs). As we highlighted in our blog on the company’s January 2018 proposal, the plan provides a framework that enables the cost of fully replacing LSLs, whether owned by the utility or by customers, to be shared by its 300,000 customers. As far as we know, this is the first comprehensive, voluntary LSL replacement program developed by an investor-owned utility in the country.

In its plan, American Water cited both long-term health and economic benefits that would be realized from avoiding partial replacements when rehabilitating water mains and laterals. The plan showed that having a single contractor handle the entire line reduces the overall cost by 25 t0 30%. It also avoids the likely increased risk of consumer’s exposure to lead when only part of the lead pipe is replaced.

IURC’s approval found the plan “to be reasonable and in the public interest.” Even though the customer will continue to own the service line, American Water will be allowed to add the cost to remove and replace the customer-owned portion to the value of the utility’s property. The increase would be considered an infrastructure improvement cost once the new service line is placed into service.

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Also posted in Drinking Water, lead, States / Tagged , , , | Comments are closed

Paint-lead hazard standard – A reconsideration

Tom Neltner, J.D.is Chemicals Policy Director

After 20 years working on lead poisoning prevention, it has become almost second nature for me to object when someone suggests that children eating paint chips is a significant route of exposure. All too often, the claim implies that the blame rests with parents who are not conscientious enough to clean or maintain their home or to properly care for their children. The implication is demeaning to the parents and distracts from the often – invisible lead dust hazards on floors that pose the greatest risk to children. So when I hear that idea, I quickly respond that dust is the key route of exposure.

However, a discussion with Hannah Chang at Earthjustice over my blog on the Environmental Protection Agency’s (EPA) July 2, 2018 proposed rule helped me realize that I was misguided with regards to defining the hazards of lead-based paints. She is the main attorney for the organizations that convinced a panel of judges in the Ninth Circuit Court of Appeals to order the EPA to update its lead-based paint hazard standard.

Hannah Chang told me I missed the most compelling point when I pointed out in my previous blog that “EPA did not appear to have considered HUD’s 2007 American Healthy Housing Survey, which should provide a solid basis for identifying the relationship between lead in paint and lead in dust.”  She was right; my logic was too focused on dust as the primary source of exposure. Here is my reasoning; it may be helpful to those planning to submit comments to EPA by the August 16 deadline on the proposed rule.

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Also posted in EPA, Health Policy, lead, Regulation / Tagged , , | Read 2 Responses

Lead service line inventories – Indiana as a good model of a voluntary survey

Tom Neltner, Lindsay McCormick, and Audrey McIntosh

This blog is part of a series focused on how states are handling the essential task of developing inventories of lead service lines (LSLs) and making them public. The first blog identified 14 states that were taking on the issue: 4 with mandatory programs and 10 with voluntary. The second blog described programs in four states that mandate an inventory. In this blog, we highlight Indiana’s 2016 voluntary survey of utilities operating community water systems (CWSs) as a model because it ask utilities to: 1) identify who owns the line and provide the legal basis for that claim; and 2) rate its confidence in its estimates on a 1 to 10 scale. 

We found no other state survey asked about LSL ownership even though it is a central question in determining who is expected to pay for replacement. The Environmental Protection Agency’s (EPA) National Drinking Water Advisory Council (NDWAC) recommended[1] in 2015 that the agency require utilities to provide states this information as part of a revised Lead and Copper Rule (LCR). Unfortunately, 43% of the 781 CWS did not respond to Indiana’s survey, revealing a serious limitation of voluntary surveys.

In January 2016, a month before EPA encouraged states to develop an inventory of LSLs and make it available to the public, the Indiana Department of Environmental Management (IDEM) sent a two-page survey to utilities that operate CWSs in the state asking about drinking water service lines. The agency posted scanned PDF copies of the individual responses online but has not yet released a summary.[2]

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