EDF Health

Anti-androgenic chemicals as a class of related substances with cumulative toxicological effects

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: November 14, 2022

Maricel Maffini, consultant, and Tom Neltner, Chemicals Policy Director

Scientists and regulators have known for decades that certain chemicals disrupt the actions of male hormones—identified collectively as androgens—in the body. Because of their effects, these chemicals are called anti-androgens or anti-androgenic chemicals.

During gestation, fetal testes begin producing testosterone, the critical hormone required to develop reproductive organs and genitalia. Insufficient production of testosterone leads to malformation of the genital tract that may need corrective surgery in infant boys and may result in reproductive health problems later in life. Ortho-phthalates (aka phthalates), known to interfere with the production of fetal testosterone, are considered anti-androgenic chemicals.

Although phthalates are perhaps the most recognizable group of anti-androgenic chemicals in the diet, there are others, including bisphenol A (BPA), propyl paraben, and certain pesticides used in food crops. Because they cause similar harmful effects, namely adverse health outcomes for male reproductive system, their safety assessment must take into account the cumulative effects of similar substances in the diet as established by law. But what does “cumulative effect” mean? Below, we use a recent study to explain what it means, why it is important, and why FDA is failing.

Biology is not math and the concept of something from nothing Read More »

Posted in Adverse health effects, FDA, Phthalates / Tagged , , , , | Authors: / Read 1 Response

Helping EPA identify and protect those at greater risk from chemicals undergoing TSCA risk evaluation

By Jennifer McPartland / Published: December 10, 2021

Jennifer McPartland, Ph.D., is a Senior Scientist, and Lariah Edwards, Ph.D., is an EDF-George Washington University Postdoctoral Fellow

EPA Administrator Michael Regan recently completed a five-day “journey to justice” tour, highlighting communities across three US states that have been adversely affected by decades of chemical and air pollution. EPA’s focus on protecting those whose health is at greater risk, including communities disproportionately burdened by harmful chemical exposures, must be a priority in its implementation of the Toxic Substances Control Act (TSCA).

This week, EDF submitted comments to EPA to support the agency’s review of nine widely used substances currently undergoing TSCA risk evaluation: 1,3-butadiene, formaldehyde, and seven ortho-phthalates (phthalates). Our comments identify key groups that are at greater risk from these chemicals because they are more susceptible to their effects or are disproportionately exposed from environmental releases. Importantly, while our comments involved a broad review of the public literature, they do not capture all groups potentially at greater risk to exposure from these substances—and we strongly urge EPA to comprehensively identify all such groups using its information authorities as needed. Read More »

Posted in TSCA reform / Tagged | Read 1 Response

FDA and industry continue to ignore cumulative effects of chemicals in the diet

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 24, 2021

Tom Neltner, Chemicals Policy Director and Maricel Maffini, consultant

The Food and Drug Administration (FDA) has made no apparent progress to comply with the legal requirement that it consider the cumulative effect of chemicals in the diet that have similar health impacts when evaluating the safety of an additive. A year ago, on September 23, 2020, EDF and 11 other organizations[1] filed a formal petition with the agency documenting the problem and asking it begin complying with the law.

We reviewed FDA and industry actions since the petition was filed and found that both continued to ignore the requirement 100% of the time in:

  • Generally Recognized as Safe (GRAS) notices in which companies were required to consider the cumulative effect as part of their determination that a substance’s use was safe;
  • FDA’s responses to those GRAS notices where it found “no questions” with the flawed safety determinations; and
  • FDA’s revised guidance to industry on use of recycled plastics in food packaging.

The agency’s only response to our petition was a March 2021 letter saying it “has not reached a decision due to competing priorities” and that the “petition is currently under active evaluation by [its] staff.”

From what we can see, FDA and industry continue to make safety determinations about chemical additives without regard to their overall effect on individuals’ health and their legal obligations. Is it any surprise that consumers continue to rate chemicals in food their #1 food safety concern? Read More »

Posted in FDA, Food, GRAS, Health policy, PFAS / Tagged , , | Comments are closed

FDA takes an important step by phasing out paper greaseproofing agents containing a specific PFAS

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 4, 2020

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

Last week, the Food and Drug Administration (FDA) announced the phase-out of per- and polyfluorinated alkyl substances (PFAS) used to greaseproof paper and paperboard food packaging made from a specific type of short-chain PFAS known as 6:2 fluorotelomer alcohol (6:2 FTOH).  The action, narrow as it is, is welcome news for efforts to protect public health and the environment from the risks posed by short chain PFAS, known as “forever chemicals” because they do not degrade.

FDA secured voluntary agreements with three companies, Archroma, Asahi Glass, and Daikin, to phase-out products based on 6:2 FTOH. A fourth company, Chemours, asked FDA to suspend the agency’s approvals on its products containing the PFAS one year ago. The action affects 15 food contact substance notifications (FCN) approved by the agency between 2006 and 2016. It does not address 13 FCNs for similar greaseproofing uses made from PFAS other than 6:2 FTOH. And, under the agreement, consumers may still find 6:2 FTOH-laden, carry-out containers until June 2025.

The process FDA took, and the time it took to get there, reveals the significant difficulties the agency has in reversing past actions in the face of mounting evidence of a chemical’s risk:

  • FDA must seek out information because companies have no obligation to affirmatively notify the agency of new studies showing potential problems;
  • When FDA finds the information and identifies potential safety concerns, it appears to act as if it has the burden of proving the use is no longer safe; and
  • FDA continued approving uses of 6:2 FTOH even after it identified problematic data gaps.

These difficulties reinforce the need for actions being taken by states such as Washington, Maine, New York, and California, by Congress, and by retailers to reduce uses of PFAS in their products. When it comes to food packaging, PFAS are dinosaurs and their time is running out.

Read More »

Posted in FDA, Food, Health policy, PFAS / Tagged , , , , | Comments are closed

A gap remains in the circular economy conversation: Toxic chemicals in packaging

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: February 27, 2019

Boma Brown-West, Senior Manager, Tom Neltner, Chemicals Policy Director, and Michelle Harvey, Consultant.

This is the first blog in a series evaluating the challenges associated with single-use food packaging waste.

This week Walmart joined a growing number of companies that are trying to advance the circular economy for packaging. Like previous commitments from Nestle, Coca-Cola and McDonald’s, Walmart is stepping up its efforts to use more recyclable packaging, incorporate more recycled content, and accelerate development of collection and recycling infrastructures. EDF has a long history fighting for greater and smarter plastics recycling, so we are pleased to see more companies working to eliminate plastic packaging waste from our environment. However, something is often missing from their statements: commitments for safer packaging free of toxic chemicals.

What defines safer packaging?

There are many facets to sustainable packaging: recyclability, reusability, lower material and energy inputs, and the avoidance of toxic chemicals.  A significant amount of virgin plastic used in packaging currently contains toxic chemical additives such as ortho-phthalates or contaminants such as heavy metals. These chemicals have been linked to diseases and health disorders, such as reproductive problems and impaired brain development. When tainted plastic packaging is reused or recycled, these toxic chemicals persist and may accumulate to worrisome levels until the packaging is retired, posing long-term threats to our health.

Read More »

Posted in FDA, Food, Regulation / Tagged , , , , , | Comments are closed

We are what we eat: New paper outlines how the regulatory gaps in the US threaten our health

By Sarah Vogel / Published: December 20, 2017

Sarah Vogel, Ph.D., is Vice-President for Health.

In a new paper published in PLoS Biology today, Maricel Maffini, Tom Neltner and I detail the regulatory gaps in how the US manages chemicals in food. We explore how failures in our current regulatory system put the public’s health at risk as exemplified in the case of perchlorate, a chemical allowed in food and a well-known endocrine disrupting compound. Perchlorate’s ability to disrupt normal functioning of the thyroid means that even low levels of exposure, especially in those with inadequate iodine intake, can adversely impact the developing brains of infants and children. It is not a chemical that should be in the food of pregnant women, infants and children. And yet it is, and the levels children consume have increased in recent years.

Read More »

Posted in FDA, Food, GRAS, Health science, Perchlorate, Public health / Tagged , , , , , | Comments are closed