Monthly Archives: March 2023

Carts Before Horses: Vinyl Institute Calls For EPA To Evaluate Risk Without Data

By Samantha Liskow / Published: March 28, 2023

Horse attached to the wrong end of the cart. Caption says "Whose bright idea was this again?"

What’s New?

Yesterday, (March 27), EDF—together with the National Wildlife Federation—filed a “friend of the court” brief in the case of Vinyl Institute v. EPA. We expressed our support for EPA’s authority to order companies to 1) Conduct health and safety studies for their chemicals and 2) Turn over those test data to EPA when the agency is evaluating risks the chemicals may pose to humans, wildlife, or the environment.

The Vinyl Institute, which lobbies for companies making vinyl chloride and other chemicals used to make PVC plastic, disagrees. It brought a case against EPA on behalf of its members, asking the U.S. Court of Appeals in Washington, DC, to overturn EPA’s order to test 1,1,2-trichloroethane—a chemical known to harm living beings.

Why It Matters

This case could affect EPA’s ability to order companies to conduct health and safety studies for their chemicals, and, by extension, the agency’s ability to regulate those chemicals. Our brief to the court examines the history that led Congress to grant EPA authority to issue test orders and explains why it is critical for EPA to retain this authority.

The Backstory

The Toxic Substances Control Act (TSCA), the nation’s primary chemical law, was first enacted in 1976. For decades afterwards, EPA managed to collect test data for only a few chemicals; in some years, EPA collected no test data from companies at all.

The original TSCA law required EPA to go through lengthy procedures and make risk determinations about a chemical before it could seek any data from companies. Members of Congress recognized this was a no-win position for EPA and tried for many years to change the law. In 2016, Congress enacted major bipartisan reforms to TSCA, giving EPA power to order companies to test their chemicals when the agency needs data to complete risk evaluations of those substances. This change was lauded by members of Congress and many others as one of the most important improvements to TSCA.

The Current Case

EPA has designated 1,1,2-trichloroethane as a “high priority” for risk evaluation and possible regulation under TSCA. The agency issued the test order because it has some data indicating that the chemical is toxic to birds—but EPA needs more information on just how toxic it is to understand the risks. The Vinyl Institute essentially argued that EPA should have shown the risk to birds before it issued a test order—a classic case of putting the cart before the horse.

On behalf of several multibillion-dollar companies, which produce vinyl chloride and are part of the case, the Vinyl Institute also complained about the cost of the test.

What’s Next?

The court will review the briefs and issue a decision. In the meantime, chemical companies are challenging other EPA testing orders in court, and we are keeping a close eye on those cases. We will continue supporting EPA’s ability to exercise the authority Congress gave it–along with the ability to gather the information it needs to understand how chemicals pose risks to us and the environment and it can take the actions necessary to protect us.

Go Deeper

Read the briefs for the case Vinyl Institute v. EPA:

Posted in Industry influence, Public health, TSCA / Authors: / Comments are closed

Rhode Island expects LSL replacements to be ‘simultaneous and complete’ when funded by SRF

By Roya Alkafaji / Published: March 17, 2023

Tom Neltner, Senior Director, Safer Chemicals Initiative
and Roya Alkafaji, Manager, Healthy Communities

What Happened: The Rhode Island Department of Health (RIDOH) published notices on January 18 and January 30 indicating that Providence Water would need to stop partial replacement of lead service lines (LSLs) when the work is funded by the State Revolving Fund (SRF) program.

RIDOH specified that “only [LSL] replacement that results in simultaneous and complete replacement of both the public (water main to curb stop) and private (curb stop to water meter inside buildings) portions of the lead service lines will occur.”

Why It Matters: EPA made it clear in its FAQs that federal SRF funds should not be used to support harmful partial LSL replacements, which increases the risk of lead exposure in drinking water.[1] To our knowledge, Rhode Island is the first state that has applied its National Environmental Policy Act (NEPA)-like environmental review process to protect residents from partial LSL replacements by requiring the simultaneous and complete replacement of an LSL. All states have a similar review process pursuant to EPA requirements and should be taking similar action.

Our Take: RIDOH’s determination is an important application of the state’s environmental review requirements for its SRF program. We strongly supported RIDOH’s action in comments. We also asked that it be applied to six other SRF-funded projects that are likely to disturb LSLs, like water main replacement and asked for a public hearing if RIDOH allows partials for those other projects.

The Backstory: EDF objected to RIDOH’s March 2022 proposal to grant Providence Water a categorical exclusion that would have allowed partial LSL replacements. We reasoned that the practice would “disproportionately and adversely affect the health of low-income, Black, Latinx, and Native American residents by increasing their risk of exposure to lead in drinking water.” Accordingly, the utility was not eligible for a categorical exclusion and must either stop partial LSL replacements or conduct a full environmental review. This review would likely demonstrate the project was not eligible for funding.

Later, RIDOH withdrew the proposal based on follow-up discussions with EDF and separate discussions with Childhood Lead Action Project.

Go Deeper: Read RIDOH’s April 2022 and January 2023 public notices, a related civil rights administrative complaint filed with EPA, and EDF’s objections to RIDOH’s April 2022 proposal.

 

[1] EPA Frequent Questions about Bipartisan Infrastructure Law State Revolving Funds and LSLR:

“Question 4. If some customers (e.g., homeowners) refuse to allow the water utility access to replace the privately-owned portion of the lead service line, does this affect the project’s DWSRF funding?

State DWSRF programs may still fund the overall project but are strongly encouraged to use technical assistance and other outreach methods to achieve the fullest possible participation. If the customer continues to refuse access, then the water system should leave the publicly-owned portion of the lead service line in place (so as to not create a partial replacement) and document this action. To be clear, partial service line replacements are not eligible for DWSRF funding (from any DWSRF funding source).”

Posted in Civil rights / Tagged , , , , , | Comments are closed

Broken GRAS: FDA’s half-step to limit bias and conflicts of interest in GRAS determinations may backfire

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: March 15, 2023

Tom Neltner, Chemicals Policy Director and Maricel Maffini, consultant

What Happened? FDA finalized a long awaited guidance for industry in December to help reduce conflicts of interest and bias when a chemical manufacturer chooses to convene an expert panel to assess whether a new chemical additive is generally recognized as safe (GRAS).

Why It Matters: As written, FDA’s Best Practices for Convening a GRAS Panel guidance is excellent. If food companies convene GRAS panels consistent with the guidance, the panels’ evaluations will be more credible because they should have less of the pervasive bias and conflicts of interest that plague the current system and all too often result in unsafe chemicals being added to food. But that’s a big if.

Our Take: Unfortunately, we think the guidance is likely to backfire because of the limited scope — FDA explicitly makes GRAS panels optional – a choice the agency made when it finalized the GRAS rule in 2016. Chemical manufacturers will simply avoid convening GRAS panels, relying solely on their employees or a consulting firm they hire to conduct these safety evaluations. These employees and consultants typically have significant bias and conflicts of interest because positive opinions help their employer or client. We raised this issue in comments to FDA, calling for the best practices to apply to everyone involved in the safety evaluation process. FDA did not address our comments in their recommended best practices in the revised final guidance.

While making GRAS panels optional is a serious problem, a more fundamental concern is that FDA may not have an opportunity to review the GRAS safety evaluations made by employees or hire consultants because the company chooses not to notify the agency. FDA’s Office of Food Additive Safety fails to consider just how often companies choose not to tell the agency that a new chemical is being added to food. In our Broken GRAS series, we provided six examples of the serious risk posed by the GRAS system, the most public being hundreds of people sickened due to consumption of tara flour, an ingredient in a Daily Harvest frozen meal. Last November, using marketing materials we showed FDA that the number of new chemicals bypassing its review likely outnumber those voluntarily submitted to the agency.

We see no evidence that the agency systematically investigates or even audits the GRAS determinations that bypass their review despite promises made by the agency over the years and a scathing 2010 report by the U.S. Government Accountability Office calling for action.

Next Steps: In his effort to reform FDA’s dysfunctional food safety program, FDA Commissioner Califf told a reporter that “I want to throw in chemical safety as another really, really important area for the future – for humankind, really – and where science is evolving rapidly.”[1] If he follows through, fixing GRAS is an important step to rebuild consumer confidence and reduce the ongoing risk to public health. If he fails, the agency will continue to be hamstrung in preventing health risks posed by chemicals of unknown safety.

Go deeper: Broken GRAS series, Neltner et al (2013) Conflicts of Interest in Approvals of Additives to Food Determined to Be Generally Recognized as Safe: Out of Balance; Toxic Free Act; Food Chemical Reassessment Act.

[1] FoodFix, January 31, 2023 edition.

Updated April 9, 2023 to add link for Broken GRAS series.

Posted in Broken GRAS, Conflict of interest, FDA, GRAS / Tagged , , , | Authors: / Read 1 Response

TSCA And The East Palestine Ohio Train Derailment Are Related–Here’s How

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: March 14, 2023

Derailed train, leaking toxic chemicalsBy Maria Doa, PhD, Senior Director, Chemicals Policy, and Lauren Ellis, MPH, Research Analyst

What Happened:  We recently expressed concern to EPA about its conclusion that “distribution in commerce” (including the transportation of chemicals) does not contribute to the unreasonable risk for any of the first 10 chemicals evaluated under the Toxic Substances Control Act (TSCA). 

In response, EPA stated that exposures from the distribution of chemicals in commerce would be minimal “given the fact that these chemicals are transported according to existing hazardous materials transportation rules.” 

Why It Matters: EPA does not currently quantify exposures and risks from spills, leaks, and other releases from transportation incidents. But people can be—and are—exposed to toxic chemicals at all stages of the chemical lifecycle, from these incidents to chemical facility releases.

For example, last month, a Norfolk Southern freight train hauling several railcars carrying toxic chemicals derailed in East Palestine, Ohio. This is just the latest example of how accidents involving highly toxic chemicals can have harmful impacts—both short- and long-term—on communities’ health and welfare.

The Ohio train derailment not only put several surrounding communities at risk of chemical pollution and negative health outcomes, but also highlighted the connection between TSCA and the risks of toxic chemicals from transportation accidents.

 

What’s Next: To accurately assess chemical risk under TSCA, EPA should consider data on spills, leaks, and releases from derailments, collisions, and other transportation incidents in its risk evaluations. These releases and exposures simply cannot be ignored.

By expanding evaluations to include the risks of chemicals at all stages of the chemical lifecycle, EPA can better protect communities.

Go Deeper: Visit our Deep Dives blog for a more in-depth analysis of this issue. 

Posted in Deep Dives, Public health, TSCA / Read 2 Responses

Unleading Baby Food: FDA’s proposed limits are a positive step, but…

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: March 1, 2023

Tom Neltner, Senior Director, Safer Chemicals

What Happened: FDA recently released draft action levels for lead in foods intended for babies and young toddlers.1 Action levels represent the point above which FDA is likely to regard food as adulterated – essentially unsafe – and seek a recall. This is a key step in implementing FDA’s Closer to Zero Action Plan.

  • Lead limits would be 10 parts per billion (ppb) for most foods.
  • Limits would be 20 ppb for dry infant cereals and single-ingredient root vegetable products, because these products may have greater lead contamination levels. (Root vegetables are primarily carrots and sweet potatoes.)

The new action levels do not apply to juices; FDA proposed limits on those in April 2022.

Why It Matters: There is no safe level of lead in the diet.

For young children living in homes without lead pipes or lead paint, diet is the primary source of their lead exposure. FDA makes clear in the proposal that:

“Even low lead exposure can harm children’s health and development, specifically the brain and nervous system. Neurological effects of lead exposure during early childhood include learning disabilities, behavior difficulties, and lowered IQ. Lead exposures also may be associated with immunological, cardiovascular, renal, and reproductive and/or developmental effects. Because lead can accumulate in the body, even low-level chronic exposure can be hazardous over time.”

Lead can enter the food chain through multiple sources, including crops grown in contaminated soil and/or irrigated with contaminated water, atmospheric deposition from industrial activities, and old food-processing equipment that contains lead. The objective is to get exposure closer to zero.

Our Take: We applaud FDA’s proposed limits, which are more protective than the European Union’s 2021 standards. BUT…on the flip side:

  • FDA failed to set action levels for popular grain-based snacks, like teething biscuits and snack puffs. The agency needs to rectify this failure with all deliberate speed.
  • More protective action levels are achievable, especially for non-rice cereals and for foods that don’t contain rice or root vegetables.
  • Proposed action levels do not apply to multiple categories of foods, including:
  • FDA’s justification for the draft action levels lacks transparency—undermining both credibility of the levels and the likelihood industry will comply with them.

In addition, USDA and industry need to expand their support for research on the methods for growing, harvesting, and processing root vegetables, rice, and quinoa to further reduce lead contamination in these important foods. Research should include both store-bought and homemade baby foods.

Go Deeper: Visit our new Deep Dives blog to see our 3-part series, which provides a more detailed analysis of FDA’s proposal—including our recommendations for setting more protective limits and improving the transparency and credibility of the agency’s process of setting action levels.

NOTES
1 FDA’s guidance refers to babies and young children. Younger than two is a very narrow definition of young children, especially since children up to age six are particularly vulnerable to the harm that lead causes to their brains. Other federal agencies set standards for this broader age range. Toddlers are generally considered to be between 1 and 3 years of age. Therefore, we use the term “young toddlers” to avoid confusion.

Revised on March 21 to correct quote.

Posted in Deep Dives, FDA, Health policy, Health science, Public health, Unleaded Juice / Read 1 Response

Introducing Deep Dives—EDF’s New Platform for In-Depth Scientific & Policy Analyses on Environmental Health

By Paige Baker / Published: March 1, 2023

What’s New? Today we’re launching a new digital channel for the die-hard science and policy wonks in our midst! Deep Dives is a new, long-form blog site that will offer readers in-depth scientific analyses, hard data, and practical policy prescriptions from our top environmental health experts. The authors are Environmental Defense Fund experts in air quality, chemistry, epidemiology, law, public health, and more.Illustration of a pink brain wearing glasses on a bright yellow background

Why It Matters: We have multiple audiences for our content—and data tell us they have very different information needs and preferences about format.

We are committed to giving everyone the information they want in the format they prefer—and that led us to create Deep Dives.

Here’s the Deal: On average, only about 5% of web visitors read to the bottom of any particular piece of internet content. That’s why we have moved this blog to short-form content that tells you what’s happening and why it’s important from the jump. We give you the gist, and we try to keep it under 500 words.

But we also have a specialized audience of scientists, policymakers and implementers, academics, and advocates who value the policy nuances and scientific details. The people in this group want the meaty content and all the details—and, if they are interested in the subject, they will read to the end of the post, no matter how long it is.

If that describes you, Deep Dives was conceived and created for you!

What’s Next? We may be creating a new space for the self-described geeks and wonks, but we’ll continue to give you the skinny here—and all visitors are welcome in both spaces! Be sure to subscribe to this blog to receive email notifications of new Deep Dives blogs.

Last one in is a rotten egg!


Illustration of two French bulldogs under water, wearing swimming goggles, surrounded by a colorful coral reef.

Welcome to our new Deep Divers!

Posted in Deep Dives, Health policy, Health science, Public health / Comments are closed