FDA Rule Casts More Doubt On Anti-Microbial Building Products

Bill Walsh - September 7, 2016

Last Friday, the US Food and Drug Administration (FDA) issued a new regulation that bans 19 antimicrobial chemicals, including triclosan and triclocarban, used in hand soaps. [1] According to the FDA: "Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research (CDER). "In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term."  
The FDA's action reinforces HBN's longstanding conclusion that anti-microbial substances added to building products fail to provide any additional human health protection, and are likely to do more harm than good over the long term. The substances banned by the FDA have been added to HBN's Pharos Project Chemical and Materials Library as a restricted substance list, to help building industry professionals avoid these chemicals in building products.
During the nearly 40 years [2] this issue has been pending before the FDA, the use of these chemicals has exploded into a billion dollar annual market. Manufacturers now add them to a wide array of consumer products despite a dearth of data to demonstrate efficacy in protecting human health. The FDA does not regulate their use in building products. That's the domain of the US Environmental Protection Agency, which has thus far failed to restrict them. [3]
Independent investigations have challenged the safety and the efficacy of adding antimicrobials to everyday products, as HBN has reported since 2010. In 2014, we devoted several articles to the FDA rulemaking and how the emphasis on improving human health in the green building movement is creating new opportunities to market antimicrobial products in building products. [4] The final FDA rule confirms that there is still no evidence that the use of triclosan and other antimicrobials provide human health benefits.
In 2003 the Centers for Disease Control and Prevention (CDC) concluded a comprehensive study of infection control practice with the statement that "No evidence is available to suggest that use of these [antimicrobial] products will make consumers and patients healthier or prevent disease. No data support the use of these items as part of a sound infection-control strategy." In 2012, the Canadian Medical Association called for a ban on antimicrobial chemicals in ordinary consumer products.
Since 2006, health care leader Kaiser Permanente has recommended against "environmental surface finishes or fabrics that contain antimicrobials for the purpose of greater infection control and the subsequent prevention of hospital acquired infections." In 2015 Kaiser took action to ban 15 antimicrobial chemicals from interior finishes. [5]
Why not use antimicrobials anyways "just in case?" Global health authorities are finding increasing evidence of harm. The World Health Organization included triclosan in its 2013 state-of-the-science report on endocrine-disrupting chemicals. [6] The Centers for Disease Control found triclosan in 75% of Americans tested, with levels rising from 2003 through 2010. [7] Doctors from Johns Hopkins concluded in 2012 that these levels of triclosan in the human body "were significantly associated with allergic sensitization." [8]
Triclosan is both a potential asthmagen and a persistent, bioaccumulative substance that can build up in humans, and is found in species as diverse as earthworms and bottlenose dolphins. Under certain conditions, triclosan can break down in the environment into a group of dioxins - a class of potent carcinogens and endocrine disrupters. [9] Additionally, dioxin residuals are common contaminants in this antimicrobial. [10]
The FDA decision underscores the need for manufacturers to fully disclose building product contents so that architects, designers, building owners and occupants can make informed decisions about avoiding hazards while the regulatory process grinds on. Antimicrobial products' presence in building materials is an avoidable chemical hazard that has no place in a healthy building.
 

Footnotes
[1] This version of the newsletter was edited on Sept 13, 2016 to delete the words ‘and sanitizers’ from the end of this sentence in order to avoid confusion. The FDA ruling does not apply to non-soap sanitizers.
[2] Nicole Greenfield. "The Dirt On Antibacterial Soaps." NRDC, Our Stories, March 15, 2016. https://www.nrdc.org/stories/dirt-antibacterial-soaps.
[3] One intended use of antimicrobials in building products is as a preservative. The difference between this use, and the strictly regulated use of antimicrobials that claim health benefits, can be highly misleading and will be the topic of a future article.
[4] See: Bill Walsh. "FDA Acts On Antimicrobials." Healthy Building News, January 8, 2014. http://www.healthybuilding.net/news/2014/01/08/fda-acts-on-antimicrobials. ; Davida S. Smyth, PhD. "Antibacterials In Building Products: The Good, The Bad and the Downright Ugly." Healthy Building News, November 19, 2014. http://www.healthybuilding.net/news/2014/11/19/antibacterials-in-building-products-the-good-the-bad-and-the-downright-ugly.
[5] Tom Lent. "Kaiser Says No to Antimicrobial Surfaces in Its Facilities." HomeFree, November 11, 2015. https://homefree.healthybuilding.net/news/4.
[6] Jim Vallette. "Shocking WHO Report on Endocrine-Disrupting Chemicals Calls for Building Material Ingredient Disclosure." The Signal, February 21, 2013. http://pharosproject.net/blog/show/150/who-edc.
[7] See discussion in Sarah Lott, and Jim Vallette, "Full Disclosure Required: A Strategy to Prevent Asthma Through Building Product Selection," December 2013, http://healthybuilding.net/uploads/files/full-disclosure-required-a-strategy-to-prevent-asthma-through-building-product-selection.pdf, pp. 35-36, footnote 97.
[8] See discussion in Sarah Lott, and Jim Vallette, "Full Disclosure Required: A Strategy to Prevent Asthma Through Building Product Selection," December 2013. http://healthybuilding.net/uploads/files/full-disclosure-required-a-strategy-to-prevent-asthma-through-building-product-selection.pdf, pp. 35-36, footnote 96.
[9] University of Minnesota. "Rising Levels of Dioxins from Common Soap Ingredient in Mississippi River, Study Finds." Science Daily, May 25, 2010. https://www.sciencedaily.com/releases/2010/05/100518113236.htm.
[10] "Triclosan." Pharos Project, December 19, 2013. http://pharosproject.net/material/show/2010711.

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