By Pat Rizzuto
Dec. 5 — Bisphenol A is safe at the current levels found in foods, the Food and Drug Administration said in a Dec. 5 announcement.
The agency said it reached that conclusion based on a four-year review of more than 300 scientific studies.
The studies included some in which FDA toxicologists gave pregnant rats 100 to 1,000 times more bisphenol A than people ingest in their foods, and the amount of the BPA that passed to the unborn offspring was so low it could not be measured, the agency said. In addition, more than 99 percent of ingested bisphenol A quickly metabolized into an inactive form that would not be harmful, the FDA said.
“The available information continues to support the safety of BPA for the currently approved uses in food containers and packaging,” FDA said.
FDA's conclusions are welcomed and should put to rest once and for all concerns about its safety for canned foods, John Rost, president of the North American Metal Packaging Alliance, said in a statement.
The safety declaration the FDA issued Dec. 5 is the same as it has been making for years, but backed by additional information and analyses.
That makes the assessment FDA's strongest yet, the packaging alliance said.
“This newly released documentation further builds out the science story and supports and substantiates FDA’s assessment that BPA is safe,” Steven Hentges, who manages the American Chemistry Council's Polycarbonate, BPA Global Group, told Bloomberg BNA in an e-mail.
Bisphenol A (CAS No. 80-05-7) is a major industrial chemical with 2.3 billion pounds of domestic production in 2011, according to information chemical manufacturers reported to the Environmental Protection Agency.
Manufacturers include the Bayer Group, Dow Chemical Co., DuPont and Momentive Performance Materials Holdings LLC.
Much of the production volume is used to make industrial, consumer and medical devices, including airplane and automobile components, sports safety equipment and incubators.
BPA also is used to make plastics for water cooler jugs and epoxy resins, which provide a protective lining on the inside of some metal-based food and beverage cans.
Such food applications of the chemical have spurred worldwide consumer concern due to more than 800 academic studies that have concluded bisphenol A could harm reproduction and development.
Safety assessments by regulatory agencies around the world, however, have largely concluded that bisphenol A is safe for approved uses (164 DEN B-1, 8/23/13)(37 CRR 990, 8/26/13)(36 INER 1210, 8/28/13)(2013 GLIN, 8/30/13)(41 PSLR 1041, 9/2/13)(28 TXLR 1004, 9/12/13)(2013 GLAXO, 9/17/13)(2013 GLAXO, 9/17/13).
The FDA said it will continue to study bisphenol A, work with academic institutions that are evaluating the chemical and assess new scientific literature.
As an example of ongoing research, the agency pointed to a long-term rodent toxicity study, which it has designed in conjunction with the National Toxicology Program.
That chronic study will assess a variety of endpoints, including novel ones not routinely investigated by regulatory toxicity tests but where academic researchers have reported finding harmful effects.
As an addition to that study, the FDA said it is providing animals and tissues to a consortium of grantees selected and funded by the National Institute of Environmental Health Sciences (NIEHS) to address other critical questions.
Results from other studies funded by the NIEHS will contribute to the body of scientific evidence available to regulatory agencies.
These include two studies of workers, NIEHS officials and researchers said in a December 2012 paper, “Consortium-Based Science: The NIEHS’s Multipronged, Collaborative Approach to Assessing the Health Effects of Bisphenol A.”
The first study involves cashiers who can be exposed to bisphenol A, which is used in thermal receipt paper.
NIEHS, the National Toxicology Program and the National Institute for Occupational Safety and Health also are conducting a study of 120 workers who directly handle bisphenol A where it is produced or processed.
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The FDA's Dec. 5 statement, which has a link to a compilation of newly evaluated science, is available at http://www.fda.gov/food/ingredientspackaging%20labeling/foodadditivesingredients/ucm064437.htm.
Consortium-Based Science: The NIEHS’s Multipronged, Collaborative Approach to Assessing the Health Effects of Bisphenol A provides an overview of federally-funded research on bisphenol A, and it is available at http://ehp.niehs.nih.gov/1205330/.
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