EDF Health

Selected tag(s): Food contact substance

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 »

Posted in Adverse health effects, Chemical regulation, Emerging science, FDA, Health science, Industry influence, PFAS, Public health, Rules/Regulations, Vulnerable populations / Also tagged , , , , , , | Authors: / Comments are closed

New updates to understanding packaging scorecard spur a safer & more sustainable foodservice industry

Posted in BPA, Food, Food contact materials, Food packaging, Markets and Retail / Also tagged , , | Authors: / Comments are closed

EDF joins court challenge of FDA’s refusal to ban use of perchlorate in food contact materials

Tom Neltner, J.D.is Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant

Today, EDF, represented by Earthjustice, joined with other public health advocates in filing a lawsuit to overturn the Food and Drug Administration’s (FDA) May 2017 decision, reaffirmed in April 2019 that allows the continued use of perchlorate[1], at concentrations up to 12,000 parts per million, in plastic packaging and processing equipment in contact with dry food. Perchlorate exposure is particularly dangerous for fetuses, infants, and young children, as it has been linked to developmental delays, reduced growth, and impaired learning capabilities. FDA relied on flawed reasoning while entirely ignoring important evidence developed by its own scientists revealing potentially serious risks resulting from ongoing use of perchlorate. We maintain that the intentional and unnecessary use of perchlorate in food contact materials should end.[2]

As with any litigation, we take this action reluctantly. We have long questioned FDA’s decisions that ignore evidence that endocrine disruptors like perchlorate can cause harm at levels the agency systematically dismisses as trivial. We have also pushed back on FDA’s decisions that allow toxic chemicals to be used in packaging and processing equipment that contact food ingredients multiple times from the farm to the grocery store shelf when the exposure estimate is based solely on the amount of the chemical that may migrate into food from the final product packaging. Agency assertions that its estimates are based on worst-case assumptions are misleading when they only consider a single contact. While FDA’s initial decision in November 2005 allowing the use of perchlorate-containing plastic raises all of these problems, the agency’s failure to address its own data and accompanying analysis by its own scientists that was published a decade later has left us with little choice but to act.

Read More »

Posted in Emerging science, Health policy, Health science, Public health, Regulation / Also tagged , , | Authors: / Comments are closed

FDA-approved PFAS: A serious breakdown in assessing food additive safety

Tom Neltner, J.D., Chemicals Policy Director, and Maricel Maffini, Ph.D., Independent Consultant

This blog is the fourth in a series describing information we discovered in reviewing thousands of pages from the Food and Drug Administration’s (FDA) response to our Freedom of Information Act (FOIA) of the agency’s approval of 31 Food Contact Substance Notifications (FCNs) from 2002 to 2016 submitted by six companies for 19 distinct chemical mixtures of per- and poly-fluorinated substances (PFAS).

In this blog, we identify one company’s serious breach of its obligation to provide FDA with all relevant toxicology data. While hindsight is 20/20, we have reason to believe that if FDA had had all relevant information, it would have demanded more studies potentially revealing risks that are only now coming to light with related chemicals. Though we have not completed a similar review for the other companies, we think this inadequate approach to chemical safety is not unique to a single company, and FDA should reassess all its reviews given what is now known about PFAS chemicals.

Safety assessment requirements for food additives – including food contact substances

When a company seeks FDA’s approval of food additives (including food contact substances), it is required to provide the agency with all relevant chemistry, toxicology and environmental data so it can conduct a safety assessment. While the agency typically conducts a literature search of its own and of public databases, the company that is claiming the chemical’s use is safe is obligated to include any data that is inconsistent with the company’s conclusion.

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Posted in Drinking water, FDA, Food, Health policy, PFAS, Public health, Regulation / Also tagged , , , | Read 1 Response