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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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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Posted in Drinking Water, lead, Public Health, 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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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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Mandatory lead service line inventories – Illinois and Michigan as strong models

Tom Neltner, J.D.Chemicals Policy Director and Lindsay McCormick, Project Manager

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: four with mandatory programs and ten with voluntary.  In this blog, we explore the four mandatory programs and highlight Illinois and Michigan as strong models for other states to consider. 

Four states – California, Illinois, Michigan and Ohio – require utilities that operate community water systems (CWSs) to identify and report to the state in some form their number of lead service lines (LSLs). Illinois and Michigan both have strong approaches that could serve as models for other states and EPA to require nationally. California’s approach is seriously flawed because it ignores part of the service lines and can be misleading. Ohio requires utilities to either report they have zero LSLs or provide maps where the LSLs are likely to be found, with no requirement to provide an estimated number. We explore all of these approaches below.

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Posted in Drinking Water, EPA, Health Policy, lead, Public Health, Regulation, States / Tagged , , , , , , | Comments are closed

American Academy of Pediatrics calls for “urgently needed reforms” to fix broken food additive regulatory system

Tom Neltner, J.D. is Chemicals Policy Director

Today, the American Academy of Pediatrics (AAP) released a “Food Additives and Child Health” policy statement calling for “urgently needed reforms to the current regulatory process at the US Food and Drug Administration (FDA) for food additives.” The policy applies to chemicals deliberately added to food or to food packaging or food processing equipment that get into food. These substances are used to flavor, color, preserve, package, process and store our food, but many never appear among the list of ingredients. AAP’s statement calls specifically for the following:

  • “Greatly strengthening or replacing the GRAS [Generally Recognized as Safe] determination process;
  • Updating the scientific foundation of the FDA’s safety assessment program;
  • Retesting all previously approved chemicals; and
  • Labeling direct additives with limited or no toxicity data.”

EDF applauds AAP’s policy statement and its decision to add its influential voice to the rising call for reform of the process by which FDA and food manufacturers decide additives are safe. AAP, a professional society representing 67,000 pediatricians, develops policy statements regarding federal, state, and community policies that affect children through an extensive, deliberative process that draws on tremendous scientific expertise. As with past policies, such as those concerning lead toxicity and fruit juice consumption, this statement on chemicals in food presents a well-reasoned assessment of the problem and clear recommendations for reform.

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Posted in FDA, Food, GRAS, Health Policy, Health Science, perchlorate, PFAS, Public Health / Tagged , , , , , , , | Comments are closed