A chemical once commonplace in baby bottles was singled out for concern and investigations in the mid-2000s after it was linked to possible health risks. Selective bans and restrictions on the chemical Bisphenol A soon followed in a number of Western nations.

The perception that sufficient action was ultimately taken largely put the controversy over BPA to bed, although scientists continued looking into BPA's effects on animals — as well as into the impact of its all-too-similar alternatives.

Studies conducted at home and abroad in the years since have highlighted various links between BPA and infertility, obesity, cancer, poor fetal development, early onset puberty, type 2 diabetes, heart disease, and other ailments.

While there are outstanding concerns about BPA and its relatives, which are still used in rigid plastic consumer products, the U.S. Food and Drug Administration maintains — to the great chagrin of some scientists — that the chemical is safe "at current levels occurring in foods."

Echoing American scientists ostensibly ignored by their regulator, a European health agency recently sounded the alarm, revealing that exposure is too high and that contrary to the suggestion of the FDA, BPA does pose a danger.

Blaze News recently reached out to the European Food Safety Authority, the FDA, and the National Institute of Environmental Health Sciences for insights into the current state of scientific knowledge about BPA, the selective reduction in the recommended tolerable daily intake, and possible outstanding risks to the general public.

What is BPA?

BPA is an industrial chemical that has been produced in massive quantities since the 1960s. An estimated 22 billion pounds of BPA are produced a year.

BPA is frequently used as a structural component in clear plastic consumer products, including eye wear, cosmetics, clothing, tableware, thermal paper receipts, water bottles, water pipes, and in the epoxy resins used to line the insides of metal food cans.

The BPA market reportedly accounted for $22.69 billion in 2022 and $23.52 billion last year.

Concerns mounted earlier this century over the likelihood that when BPA leached into the food and drink it was supposed to help contain, it would adversely impact human beings' health, especially that of unborn babies and newborns. In addition to exposure via food, humans can also absorb BPA through the skin.

BPA is a known endocrine disruptor, meaning that it can alter hormone activity thereby adversely impacting various biological processes regulated by the endocrine system, including those related to reproduction — at a time when fertility problems are on the rise.

In its 2003-2004 National Health and Nutrition Examination Survey, the Centers for Disease Control and Prevention indicated there were detectable levels of the chemical — which mimics the effects of estrogen in the body — in 93% of over 2,500 urine samples from people over the age of six. Later studies highlighted the presence of BPA in the blood and tissues of adults and children alike, and in breast milk, amniotic fluid, and placental tissue.

Protecting kids

Around the mid-2000s, the controversy around BPA largely centered on its use in baby-related food delivery services and packaging. The U.S. was among the countries that responded to the outrage with investigations and partial bans.

Minnesota passed the first selective state ban on BPA in 2009. Connecticut was reportedly next up, then a dozen more states adopted policies regulating the use of the chemical in consumer products.

Lawmakers and consumer groups across the country leaned on companies to stop manufacturing baby bottles and toddler cups using the chemical ingredient. Companies like Playtex and Gerber obliged them in short order.

Despite the FDA noting in an August 2008 draft report that BPA remained safe in food contact materials — a stance it maintains to this day — it was met with a citizen petition months later from the Natural Resources Defense Council requesting that the Commissioner of Food and Drugs issue a rule barring the use of BPA in human food and packaging and revoking regulations permitting the use of any food additive that might lead to BPA food contamination.

The FDA effectively told the concerned citizens to pound sand and reiterated its commitment to continuing its investigations into the chemical's health effects. In an apparent act of appeasement, the FDA did, however, amend its food additive regulations, effective 2012, to no longer "provide for the use of polycarbonate (PC) resins in infant feeding bottles (baby bottles) and spill-proof cups ... because these uses have been abandoned [by manufacturers]" — not because of safety concerns.

Responding to a petition from Sen. Edward Markey (D-Mass.), the FDA amended its regulations in 2013 to no longer provide for the use of BPA-based epoxy resins in packaging for baby formula.

During the uproar over BPA, other Western nations similarly took precautions even though the science was unsettled.

Canada, for instance, which had been the first country to declare BPA a "dangerous substance," determined that while most citizens had low to very low exposure levels of BPA that ostensibly did not pose a health risk, "There was a potential concern for infants, which led to added protective measures."

The northern nation ultimately made it illegal to manufacture, import, advertise, or sell polycarbonate baby bottles that contain BPA.

In 2011, the European Union banned the use of BPA in baby bottles and toddler cups.

Rat problems

The European Chemicals Agency's Member State Committee unanimously agreed in 2017 that BPA-A is a "substance of very high concern because of its endocrine disrupting properties which cause probably serious effects to human health."

In recent years, other agencies at home and abroad have similarly expressed concern about persisting threats posed by the profitable chemical.

The FDA, however, maintains that "BPA is safe at the current levels occurring in foods," having apparently been unswayed by various recent damning studies, including those which revealed:

• Exposure to BPA and its alternatives can impair female rats' fertility and disrupts male rats' sperm production as well as the DNA in their spermatozoa.
• Bisephenol-exposed mice suffered accelerated mammary gland development during early puberty, which persisted into adulthood.
• BPA not only interferes with ovarian development but incurs ovarian dysfunction in mice. Additionally, "BPA at 5 mg/kg, 10 mg/kg, 20 mg/kg and 40 mg/kg significantly increased the abortion rate of the pregnant mice, and each dose of BPA significantly reduced the survival rate of the pups."
• BPA exposure in utero decreased testosterone concentration in male pups.
• BPA can "significantly increase the risk of both hormone-dependent and hormone-independent cancers," breast cancer in particular, which both the National Cancer Institute and the Institute of Medicine have recognized.

In the face of continued disagreements stateside about BPA, the FDA, the NIEHS' National Toxicology Program, and other agencies collaborated on a multi-year rat model-based BPA research program called the "Consortium Linking Academic and Regulatory Insights on Bisphenol A Toxicity," or CLARITY-BPA.

This multi-agency initiative published its draft core report in 2018 and then a compendium of findings in October 2021.

Blaze News reached out to Dr. Brandy Beverly, a health scientist with the Office of Health Assessment credited with helping design and draft the final BPA report, for comment. A NIEHS spokesman responded and highlighted some interesting takeaways:

• "The core study showed no changes in brain tissue in rats. University researchers found some structural changes, and they observed alterations in the expression of estrogen and androgen receptors. They also discovered changes in the expression of genes involved in sexual differentiation and neuroendocrine function in the hypothalamus, hippocampus, and amygdala, and limited sex-specific effects on learning and memory, among other results."
• "Cancer rates in female rats increased following administration of the lowest BPA dose in the core study, but authors of that study concluded that was not due to the chemical because effects were not seen at higher doses. University scientists found that low-level exposure in rodents caused changes in mammary gland development that may contribute to increased cancer risk, whereas higher doses did not cause those changes."
• "Neither the core study nor the investigative research reported cancerous lesions in rodents following exposure to BPA. However, BPA did increase cancer following a later-life estrogen exposure simulating the aging human male, with the greatest effects observed at the per-day dose of 2.5 micrograms BPA per kilogram body weight. Also, evaluation of the developing male prostate and urethra showed a smaller urethra following exposure to low doses of BPA or ethinylestradiol, a synthetic estrogen."

The spokesman noted that despite the "illuminating" collected findings, the authors of the multi-agency report "did not reach a consensus."

While the FDA subsequently declared BPA "safe for the currently authorized uses in food containers and packaging," there was apparently a great deal of resistance to the regulator's framing.

'Their decisions rely on 4 incorrect assumptions.'

According to a peer-reviewed 2020 review published in the journal Endocrinology, "A majority of the academic scientists that participated in the CLARITY-BPA study disagreed with the FDA's published conclusions."

In the CLARITY-BPA's draft core study report, a "wide range of adverse effects was reported in both the toxicity and the mechanistic endpoints at the lowest dose tested (2.5 micrograms/kg/day), leading independent experts to call for the lowest observed adverse effect level (LOAEL) to be dropped 20 000-fold from the current outdated LOAEL of 50 000 micrograms/kg/day," said the review.

"Despite criticism by members of the Endocrine Society that the Food and Drug Administration (FDA)'s assumptions violate basic principles of endocrinology, the FDA rejected all low-dose data as not biologically plausible," said the 2020 study.

'The harmful effects from BPA can occur at minuscule levels.'

Instead, the FDA doubled down on its longstanding position.

"Their decisions rely on 4 incorrect assumptions: dose responses must be monotonic, there exists a threshold below which there are no effects, both sexes must respond similarly, and only toxicological guideline studies are valid," added the review.

The review did not mince words, concluding that the "FDA has abrogated its responsibility to ensure the safety of food and food/beverage packaging in the US, and the FDA continues to allow industry to declare chemicals such as BPA to be safe."

Dr. Linda Birnbaum, former director at NIEHS and NTP, said in a 2022 statement when petitioning the FDA to reconsider the safety of BPA in food packaging, "The scientific evidence is now more than enough to require strict limits on the use of BPA in packaging and plastics that come in contact with our food."

Too much BPA

The European Food Safety Authority, which admittedly applies different methods for quantifying risk in humans than some other major agencies, alternatively concluded last year that BPA is a health concern — not just for unborn babies and newborns, as long suspected — but for all age groups.

It also lowered its estimated tolerable daily intake for BPA 20,000-fold — a decision celebrated by some scientists and criticized by others.

Dr. Claude Lambré, chair of EFSA's Panel on Food Contact Materials, Enzymes and Processing Aids, indicated that upon reviewing over 800 BPA studies published since 2013, the panel "observed an increase in the percentage of a type of white blood cell, called T helper, in the spleen. They play a key role in our cellular immune mechanisms and an increase of this kind could lead to the development of allergic lung inflammation and autoimmune disorders."

The potential for autoimmune disorders extra to possible consequences for the reproductive, developmental, and metabolic systems prompted the EFSA to greatly reduce the tolerable daily intake from the figure they set in 2015 and concluded that consumers with "both average and high exposure to BPA in all age groups exceeded the new TDI, indicating health concerns."

"Based on all the new scientific evidence assessed, EFSA's experts established a TDI of 0.2 nanograms (0.2ng or 0.2 billionths of a gram) per kilogram of body weight per day (kg/bw/day), replacing the previous temporary level of 4 micrograms [4,000 nanograms] per kilogram of body weight per day," said the agency.

A 2014 FDA hazard assessment indicated that the estimated dietary intake of BPA was 1.1 micrograms per kilogram of body weight a day for children under the age of 2 and 0.5 micrograms for those 2 and older.

An EFSA spokesman clarified to Blaze News that the new TDI represents the amount "that can be ingested daily over a lifetime without presenting an appreciable health risk."

"Exceedance of the Tolerable Daily Intake does not mean consumers face immediate harmful effects," said the spokesman. "Even in the cases where the exposure exceeds the TDI, not all individuals will necessarily develop adverse reactions over time, as is generally true for any chemical exposure. The probability that harmful effects on the immune system would develop over time can be influenced by several factors, including other stressors, genetics and nutrition.”

The EFSA apparently takes "conservative exposure scenarios" to maximize protections for even the most sensitive and vulnerable consumers.

'Studies show BPA can be absorbed into skin in minutes.'

While the EFSA now maintains the BPA is a health concern for people of all age groups, the spokesman informed Blaze News that the "population groups most exceeding the TDI are those with the lowest body weights, so they include infants, toddlers, and children."

When asked whether the FDA should change its position on BPA, the spokesman underscored that while the two health agencies were in regular dialogue, they simply drew different conclusions.

"Different scientists can have different views on methodologies and approaches," said the spokesman. "This is a normal part of the scientific process. This is how science moves forward and develops. Approaches may also differ according to the scope and objectives of different assessments. It is part of a broader conversation within the scientific community on how findings from intermediate endpoints in animals can be integrated into safety assessments in humans."

Blaze News reached out to the FDA about its markedly different view but did not receive comment by deadline.

Protections and protectors

BPA is omnipresent, but there are both groups who continue to flag its presence in various consumer products and ways for people to reduce exposure.

The Center for Environmental Health, a nonprofit watchdog that seeks to protect kids and families from toxic chemicals, is among the groups campaigning against the use of BPA in various products.

In recent years, the CEH has noted the presence of high levels of BPA in various articles of polyester-based clothing with spandex, including socks, sports bras, and athletic shirts. The watchdog went a step further, sending legal notices to various companies, including Patagonia, Sketchers, Nike, Reebok, New Balance, and Activ Pro, noting that their clothing "could expose individuals up to 40 times the safe limit" of BPA, according to California law.

On May 31, the CEH successfully struck a legally binding agreement with 30 companies including Hanes, Victoria's Secret & Co., Asics, and Dollar General, which will apparently reformulate their products accordingly.

"Studies show BPA can be absorbed into skin in minutes. Bisphenols have no place in socks made for adults, children, or babies, whose body systems are only just developing," Shakoora Azimi-Gaylon, senior director of toxic exposure and pollution prevention at the CEH, said in a statement.

The NIEHS has noted some ways to prevent or reduce exposure to BPA:

• Don't microwave polycarbonate plastic food containers, which can break down over time and at high temperatures.
• Reduce use of canned foods.
• When possible, opt for non-plastic containers (e.g., glass, porcelain, or steel), especially for hot foods.
• Check packaging to indicate it is BPA free.

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