EDF Health

Missing the forest for the trees? Are we addressing the biggest risks from exposure to phthalates?

Lindsay McCormick is a Research AnalystRichard Denison, Ph.D., is a Lead Senior Scientist

A recent study published in Environmental Health Perspectives is the first to demonstrate a link between childhood asthma and prenatal exposure to certain phthalates.  Phthalates are a group of chemical plasticizers used in hundreds of everyday products, including home construction materials, toys, food packaging, medical devices, and synthetic fragrances found in personal care products, cleaning products, cosmetics, and air fresheners.  For the most part, it is impossible for the average consumer to know what products are made with phthalates; however, if you see the word “fragrance” listed on your shampoo or sun screen, it may well contain a phthalate.  

Several studies have suggested that phthalate exposure may have an adverse impact on children’s respiratory health (for example, see here, here, and here).   However, none of these studies has considered the potential role of prenatal exposure – exposures to the fetus in the womb – to phthalates.

The prenatal period is a critical developmental window for lung and respiratory health.  Thus, researchers at the Columbia Center for Children’s Environmental Health (CCCEH) hypothesized that prenatal phthalate exposure would be associated with later development of asthma in childhood.  To investigate this hypothesis, the researchers measured phthalate metabolite levels in the urine of 300 women in the 3rd trimester of pregnancy, and then followed the children of these women to assess the extent to which they developed asthma between the ages of 5 and 11.  Read More »

Posted in Emerging science, Health policy, Health science, Regulation / Tagged , , | Read 2 Responses

FDA Says We Are All Made of Chemicals So How Can Any Be Bad For You?

By Maria Doa, PhD, Senior Director, Chemicals Policy, Maricel Maffini, PhD, Consultant, and Liora Fiksel, Project Manager, Healthy Communities

 

Woman reading product label in grocery store

What happened

You may have seen news or online content from FDA about chemicals in our foods, including that our food – and everything else in the world – is made up of chemicals.

FDA’s online content also characterizes toxic chemicals such as lead and mercury simply as naturally occurring or naturally present in our environment. It further fails to distinguish the most harmful chemicals by asserting that for all chemicals, it is the amount of the chemical that matters when determining their harm.

Why it matters

It is true that everything, including our food, is made up of chemicals. However, that does not mean that we should treat all chemicals equally.

Highly toxic chemicals such as lead, mercury, PFAS, TCE, methylene chloride, and BPA are examples of substances that should not be in our food. These toxic metals and synthetic chemicals do not have nutritional benefits and are not equivalent to the chemicals that make up the proteins, fats and carbohydrates that are necessary for a healthy diet. We should not be exposed to toxic chemicals at any level.

The suggestion that toxic metals and synthetic chemicals such as PFAS in our food are just chemicals like essential elements such as potassium in bananas is misleading and harmful.

Unfortunately, FDA accomplished just that. In a webpage released earlier last week, the agency tried to address worries about chemicals in food, an issue that consumers have been concerned about for several years. In its attempt to bring confidence about the safety of the food supply, FDA tried to normalize the presence of toxic chemicals, including neurotoxicants, carcinogens and endocrine disruptors, in our food.

Our take

If a toxic chemical such as lead or mercury is naturally occurring, is it OK?

No. While there are very low levels of these metals that are naturally present in our environment the majority of what is now in our environment is not natural background but the result of pollution and other contamination due to human activities. These levels are not “naturally occurring.”

It is also essential to recognize that naturally occurring does not equate with safety. There is no safe level of exposure to lead and mercury which are potent neurotoxicants. They are particularly harmful to infants and small children and exposure to even small amounts can cause harm.

Is there always a safe level of exposure to a chemical?

Treating all chemicals in our food the same way ignores the science. Some chemicals, in addition to lead and mercury, are so toxic that essentially any amount of exposure is of concern:

  • Chemicals like TCE associated with multiple types of cancers and harm pregnant women and infants.
  • Chemicals like PFAS also known as forever chemicals because they are so difficult to destroy that can harm pregnant women, cause cancer and harm the immune system in vanishing small quantities. For two of the PFAS, EPA just declared that there is no safe level of exposure.
  • Chemicals like BPA that harm the immune and reproductive systems, disrupts the normal function of hormones and affects learning and memory at levels 20,000 times lower than previously estimated, and
  • Chemicals like methylene chloride are associated with cancer and liver toxicity.
  • Chemicals like phthalates that also disrupt the normal function of hormones specially during development of the male reproductive tract. These chemicals are strictly limited in children’s toys due to their toxicity.

And being exposed to more than one of these chemicals that cause the same harm, such as cancer, can increase the harmful effects.

Further, Congress also recognized that some chemicals should not be allowed to be added to our food. Period. Congress included a provision known as the Delaney Clause in our food safety laws that states a food additive cannot be deemed “safe if it is found to induce cancer when ingested by man or animal.” Yet unfortunately, some carcinogens continue to be allowed.

How can we be assured of a safe food supply if the agency that is supposed to ensure safety takes the same “it’s the amount that matters” approach to these toxic chemicals as it does to salt?

And how can we have confidence that FDA will fully consider consumers in determining food safety when the agency not only falsely equates toxic chemicals with the chemicals that make up the proteins, fats and carbohydrates in our diet but also takes a patronizing approach to the public by stating that “chemical names may sound complicated but that does not mean they are not safe.”

Next steps

In the last several years, public interest organizations have petitioned FDA to review the safety of chemicals known to pose risk to health.  Many petitions are still unresolved.

FDA should recognize toxic chemicals for what they are – chemicals that can harm our health and well-being – rather than camouflage them just as any other chemical. The science and the law demand that in making decisions about food safety, FDA recognize and act on the most toxic chemicals and fully consider consumers in its decision making.

 

Posted in General interest / Authors: / Read 1 Response

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

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

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 »

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

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 »

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

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 »

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