EDF Health

FDA’s approach to systematic review of chemicals got off on the wrong foot

By Maricel Maffini, PhD, Consultant and Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: November 16, 2023

Scientist working on a digital tablet showing data on the chemical element Cadmium

What Happened?

Last month, FDA’s scientists published the toxicological reference value (TRV) for exposure to cadmium in the diet. This value is the amount of a chemical—in this case cadmium—a person can consume in their daily diet that would not be expected to cause adverse health effects and can be used for food safety decision-making. The TRV was based on a systematic review FDA scientists published last year. We will turn to the TRV itself in an upcoming blog but are focusing on the systematic review here.

In a May 2023 publication, experts in systematic reviews from the University of California San Francisco (UCSF) raised concerns about FDA’s “lack of compliance” from established procedures.

We discussed these concerns with FDA. They said:

  • “The systematic review and the TRV” publication “have both undergone external peer review by a third-party and experts in the field.” The agency expects to publish the reviews on its website, and
  • FDA “is working on developing a protocol for a systematic review of cardiovascular effects of cadmium exposure that will be published.”

Why It Matters

Systematic review is a method designed to collect and synthesize scientific evidence on specific questions to increase transparency and objectivity and provide conclusions that are more reliable and of higher confidence than traditional literature reviews. In particular, the National Academies of Sciences, Engineering, and Medicine have recommended the use of systematic reviews to establish values such as the TRV that may be used to inform regulatory decisions.

The National Toxicology Program (NTP) and others have developed specific methodologies to conduct systematic reviews. FDA’s authors said they followed NTP’s Office of Health Assessment and Translation (OHAT) handbook.

Unfortunately, FDA’s adherence to the methodology fell short on both transparency and objectivity grounds, undermining the credibility of its conclusions. Credibility is crucial because FDA’s authors stated that “this systematic review ultimately supports regulatory decisions and FDA initiatives, such as Closer to Zero, which identifies actions the agency will take to reduce exposures to contaminants like cadmium through foods.”

Read More »

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

EPA’s new chemical regulations: Backtracking on PBTs

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: November 15, 2023

NOTE: This is the fifth in a series about EPA’s regulation of new chemicals. See below under Go Deeper for links to the other blogs in the series.

What Happened?

The Environmental Protection Agency (EPA) recently proposed new regulations for its safety reviews of new chemicals under our nation’s primary chemicals law, the Toxic Substances Control Act (TSCA). One of the proposed provisions would govern which persistent, bioaccumulative,1 toxic chemicals (PBTs) should undergo a full safety review.

Why It Matters

This proposed approach would exclude certain PBTs from a full new chemical safety review. This is a concerning step backward in addressing the risks from these chemicals.

PBT chemicals do not break down readily from natural processes and raise special concern because of their ability to build up in both the environment and in people and other organisms. Even small releases of these long-lived and bioaccumulative toxic chemicals can pose long-term risks to human health and the environment. Notable PBTs—such as DDT, which affects reproduction, and methyl mercury, which is a powerful neurotoxin—impacted whole ecosystems across the United States, including the Great Lakes.

View of Lake Michigan

View of Lake Michigan Photo credit: Maria Doa

Read More »

Posted in Adverse health effects, Chemical exposure, Chemical regulation, Health hazards, Health policy, Neurotoxicity, PBTs, Regulation, Risk assessment, Rules/Regulations, TSCA / Tagged , , , , , | Authors: / Comments are closed

EPA’s new chemical regulations: Industry bias must be fixed

By EDF Blogs / Published: November 9, 2023

By Maria Doa, PhD, Senior Director, Chemicals Policy, and Colin Parts, Legal Fellow

NOTE: This is the fourth in a series about EPA’s regulation of new chemicals. See below under Go Deeper for links to the other blogs in the series.

A robotic-looking hand pushes down on the right side of a balance scale to unfairly influence the measurement.

What Happened?

The Environmental Protection Agency (EPA) recently proposed new regulations for its safety reviews of new chemicals under our nation’s primary chemicals law, the Toxic Substances Control Act (TSCA). One of these proposed provisions would govern how EPA can change the restricted approvals it issues for new chemicals that may pose unreasonable risks. EPA’s proposed approach would limit the type of stakeholders involved and the potential for stronger chemical regulations.

Read More »

Posted in Chemical regulation, Conflict of interest, Industry influence, Rules/Regulations, TSCA / Tagged , , , , | Authors: / Comments are closed

New Chemicals Rule: EPA must require more info from industry

By EDF Blogs / Published: November 3, 2023

By Maria J. Doa, PhD, Senior Director, Chemicals Policy, and Greg Schweer, Consultant

NOTE: This is the third in a series about EPA’s regulation of new chemicals. See below under Go Deeper for links to other blogs in the series.

Chemical worker in hazmat suit and full-face respirator making new chemicals for industry.

What Happened?

EPA recently proposed regulations to govern how it reviews companies’ pre-manufacture notifications for new chemicals before those chemicals can go on the market.

Why It Matters

Industry often waits until late in the review process to submit information—which means that EPA may spend a significant amount of time and effort to revise its risk assessments to incorporate the new information.

EPA has a major opportunity to improve the New Chemicals Program as it crafts these revised regulations. Requiring industry to provide additional “known or reasonably ascertainable information” as required by the law is an important component of this rule. This should reduce the amount of assessment “rework” the agency currently conducts.

Read More »

Posted in Chemical regulation, Industry influence, Risk assessment / Tagged , , , | Authors: / Comments are closed

Industry is scapegoating EPA for new chemical review delays

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: October 17, 2023

What’s Happening?

The chemical industry has an extensive—and ongoing—history of complaining about how long it takes EPA to do new chemical safety reviews.

The irony is that industry is the very player causing the delays in EPA’s review process. Clear data indicate that chemical manufacturers are primarily responsible for the length of EPA’s reviews and the backlog of cases.

Illustration of a goat looking anxious as 6 fingers point at it from outside the frame

Why It Matters

One of EPA’s vital roles is to assess the safety of new chemicals before they enter the market.

Industry’s outcry about a backlog serves as a smokescreen to pressure EPA into swiftly approving new chemicals even when they may not be safe. This would put us all at risk, particularly those who are more susceptible or maybe more highly exposed, such as children, pregnant people, and people who live and work in fenceline communities.

Read More »

Posted in Chemical regulation, Industry influence / Tagged , , , , | Authors: / Comments are closed

California mandates toxics testing/disclosure for baby food

By EDF Blogs / Published: October 11, 2023

Tom Neltner, Senior Director, Safer Chemicals and Katelyn Roedner Sutter, State Director, California

Three jars of baby food surrounded by cut-up vegetables and fruit

What Happened?

On October 10, 2023, California Assembly Bill 899, authored by Assembly Member Al Muratsuchi, became law. It requires manufacturers of baby food (other than infant formula) who wish to sell their products in California to:

  • Test a representative sample of each baby food product for four toxic elements (arsenic, cadmium, lead, and mercury) at least monthly starting in 2024.
  • Provide the test results to the California Department of Health upon request.
  • Make the results of the testing publicly available on the manufacturer’s website for the shelf life of the product plus one month. That provision goes into effect in 2025.

In addition, as FDA establishes action levels for the four toxic elements, manufacturers must also include a quick response (QR) code on the label that links to the manufacturer’s website, where consumers can find the test results for that toxic element.

Why It Matters

By requiring testing and reporting on these foods, California will provide parents and guardians with important information they need to compare products and make purchasing decisions. The law also:

  • Sets a precedent for greater testing and disclosure of food contaminants; and,
  • Is noteworthy, in that baby food companies did not oppose the bill.

The law will strengthen FDA’s efforts to reduce children’s dietary exposure to those toxic elements to the lowest possible levels, while maintaining access to nutritious foods by filling two critical gaps in FDA’s Closer to Zero program. FDA current approach sets action levels on final products that food companies must meet and requires they use preventive controls to manage toxic elements in their ingredients. It does not require final product testing or disclosure of any testing results.

Read More »

Posted in FDA, Food, Health policy, Markets and Retail / Tagged , , , , , | Authors: / Comments are closed