EDF Health

FDA’s latest study reaffirms short-chain PFAS biopersist. Now it must act.

By Maricel Maffini, PhD, Consultant, and Tom Neltner, JD

Female rat nursing multiple pups

FDA study found biopersistent PFAS in female rats and their pups,

What Happened

In December 2023, FDA’s scientists published a new study showing that when pregnant rats ingest a form of per- and polyfluorinated alkyl substance (PFAS) called 6:2 fluorotelomer alcohol (6:2 FTOH) their bodies break it down into other PFAS that reach the fetuses and biopersist in the mother and the pups.

The study also showed that the body of a non-pregnant animal produces different breakdown products that also biopersist. This study is the latest evidence that the assumptions made about the safety of short-chain PFAS (chemicals with fewer than 8 carbons) have been wrong. Read More »

Also posted in Adverse health effects, Chemical regulation, Emerging science, FDA, Health science, Public health, Rules/Regulations, Vulnerable populations / Tagged , , , , , , , , | Authors: / Comments are closed

ICYMI: Secret GRAS determinations may outnumber those FDA reviews

Quote from FDA Commissioner Robert Califf, MD. "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."

NOTE: This blog was originally published on our Deep Dives blog on April 13, 2023. It predates the recent reorganization efforts at FDA.

What Happened?

FDA estimates that, each year, food companies designate 82 new food chemicals as “GRAS” (Generally Recognized as Safe) for use in food. On average, FDA reviews only 64 of those new chemicals for safety. For the remaining 18 chemicals in FDA’s estimate, the companies making and marketing them for use in food or in the food-production process choose not to seek a voluntary review by FDA.

In comments to the agency, we said we think FDA’s estimate may be too low – and the number of new chemicals added to food that bypass FDA review may be as high as 130 new food chemicals a year (significantly higher than 18). This is based on searches of company marketing claims. In an 8-week period, we identified 10 chemicals claimed as GRAS without a submitted notice to FDA seeking voluntary review. (Please see our comments for a full explanation of our estimate.) Read More »

Also posted in Broken GRAS, Chemical regulation, FDA, Food, GRAS, Health policy, Public health, Regulation / Tagged , , | Authors: , / Comments are closed

EPA’s TCE ban: A vital step for public health

We only have until December 15, 2023, to show EPA we support
a full and rapid ban of all uses of TCE.

Take Action: Tell EPA–Ban TCE Now

What Happened?

The Environmental Protection Agency (EPA) has recently taken a significant step in safeguarding public health by proposing new regulations under our nation’s primary chemicals law, the Toxic Substances Control Act (TSCA) that would protect people from exposure to trichloroethylene (TCE), a highly toxic chemical that causes serious health risks. The proposed rule would ban the production, import, processing, and distribution in commerce for all uses of TCE.

Yet, despite the known dangers of TCE and the undeniable scientific evidence supporting the need for this action, the chemical industry is trying to undermine this critical regulation by incorrectly claiming the proposed rule is “inconsistent with the science.” Read More »

Also posted in Adverse health effects, Chemical exposure, Chemical regulation, Developmental toxicity, Health hazards, Neurotoxicity, Public health, Reproductive toxicity, Rules/Regulations, TSCA / Tagged , , | Authors: / Read 1 Response

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

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 »

Also posted in Chemical regulation, Conflict of interest, Rules/Regulations, TSCA / Tagged , , , , | Authors: / Comments are closed

New Chemicals Rule: EPA must require more info from industry

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 »

Also posted in Chemical regulation, Risk assessment / Tagged , , , | Authors: / Comments are closed

Industry is scapegoating EPA for new chemical review delays

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 »

Also posted in Chemical regulation / Tagged , , , , | Authors: / Comments are closed