The WasteWatcher: The Staff Blog of Citizens Against Government Waste

New FDA Report on BPA: It is Still Safe

The WasteWatcher is the staff blog of Citizens Against Government Waste (CAGW) and the Council for Citizens Against Government Waste (CCAGW). For questions, contact

On February 23, 2018, the Food and Drug Administration (FDA) released a statement by Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff, M.D., regarding a draft report issued by the National Toxicology Program (NTP) on the compound bisphenol A, more commonly referred to as BPA.  The report concluded that BPA, the compound used to produce strong plastic products and epoxy resins, is safe.

This study, one of the largest ever conducted, was undertaken by FDA’s National Center for Toxicological Research (NCTR), other government agencies, and academics.  Doctor Ostroff stated that the report “ … supports our determination that currently authorized uses of BPA continue to be safe for consumers.  The report also builds upon the already extensive data collected in the FDA's 2014 assessment of the safety of BPA.”

Plastic made with BPA can be found in many consumer products, such as eyewear, food storage containers, sports equipment, medical devices, and cell phones.  Epoxy resins made with BPA are durable, have strong adhesion, and are resistant to chemicals. They can be found in many consumer and industrial applications, such as a protective lining inside metal-based food and beverage cans, as an insulator in electronics, and in wind turbines.

The FDA oversees BPA usage in food products.  Substances used in packaging that migrate into food, which includes BPA, must undergo an FDA premarket approval as an indirect food additive or food contact substance.  FDA issued the first approvals for BPA in the 1960s, but the agency can make regulatory changes based on new safety or usage information.  More than 300 scientific studies have been conducted on BPA since the 1960s and reviewed by FDA experts.  To date, there is no information that has compelled a change in the agency’s assessment that BPA is safe.

Nonetheless, there have been hysterical claims for years about BPA by environmental groups, many of whom use questionable research by scientists who are on a mission to eliminate BPA’s use entirely.  They have caused so much consternation over BPA that the compound has been removed from many consumer products, such as baby and water bottles.  The National Institute of Environmental Sciences (NIEHS), headed up by Linda Birnbaum, Ph.D., at the National Institutes of Health (NIH), has funded many of these alarmist BPA studies.  Doctor Birnbaum is known for her anti-chemical activism and dispersing federal grant money to fund research on BPA.  Citizens Against Government Waste discussed this taxpayer-funded quandary in the November 2014 WasteWatcherDueling Agencies.”

What makes the February 23 report so significant is that it is a result of a three-agency, five-year collaborative, the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA), which was created in 2010 after a 2008 NTP report raised concerns about rodents exposed to low doses of BPA.  CLARITY-BPA includes the FDA, the NIEHS, and the NTP.  Experts from these agencies and academic grantees, selected by NIEHS, worked with one another to devise the research protocols and conduct various health endpoint studies.

Five dose levels of BPA were given to special research rats, from gestation to pup stage to adult, and at selected intervals, which covered the wide range of doses that have been used and studied in scientific literature.  The amounts of BPA are at levels to which humans are normally exposed and at very high levels where BPA-induced effects have been reported.  Researchers studied any effect BPA may have had on the rats, such as specific diseases or dysfunctions, over their lifetime.

The core study of the original rats is in the just-released draft.  The academic grantees are conducting studies on the core rats’ offspring or their tissues (and serum), analyzing the data for various endpoints.  The CLARITY February 2015 update report stated, “This integrated research plan was intended to eliminate variance in institutional and environmental conditions that potentially exist between studies conducted in different laboratories and to leverage extensive evaluations of internal dosimetry [internal dosages of BPA] throughout the life-stages in the chosen animal model.”  In other words, the animals were housed at the NCTR lab and exposed to BPA under identical conditions so that a researcher’s bias toward BPA should be eliminated.

On April 26, 2018, the draft report will be peer reviewed in an open forum, and the academic researchers have been sending in their research results.  This is where it will get really get interesting.  The academic scientists participating in the studies were chosen by Dr. Birnbaum, have been funded previously by NIEHS, and several are outspoken and virulent anti-BPA researchers.  Ironically, although several of the researchers expressed criticism of the types of rats that were used in the CLARITY study in a September 21, 2009 letter to the FDA,  they eagerly signed up to receive some of the more than $20 million in grant money that was to be dispersed when the consortium’s Funding Opportunity Announcement was released.  All the academics’ data is expected be released by August 2018.

Because of the protocols used and the collaborative nature of the study, which should prevent any undue variances, this should be the final word on BPA’s safety.  However, no one should doubt the desire and capability of the federal bureaucracy to continue wasting money to attempt to contradict and undermine even the most elaborate and conclusive study on any subject matter, including BPA.


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