On September 2, 2016, the U.S. Food and Drug Administration (FDA) announced its final ruling on triclosan, an active ingredient used in consumer antiseptic and antibacterial wash products. In this ruling, the FDA banned triclosan and 18 other ingredients from being marketed in commercial and consumer wash products.
The FDA says manufacturers have until September 6, 2017, to reformulate their production lines and remove existing triclosan products from the market. However, these changes will not only impact product manufacturers; the onus to remove triclosan products used in facilities and replace them with FDA-compliant products will fall on custodial managers and their teams.
Why Ban Triclosan?
Initially proposed in 2013, the FDA ruling called into question the safe use of triclosan and its inclusion in consumer washes with antibacterial properties. The proposal required manufacturers to provide data to the agency supporting the safe use and effectiveness of triclosan; however, due to a lack of new data supporting its safety along with insufficient existing data, triclosan was included among 19 ingredients no longer “recognized as safe and effective” by the agency.
“After studying the issue, including reviewing available literature and hosting public meetings, in 2013 the FDA issued a proposed rule requiring safety and efficacy data from manufacturers, consumers, and others if they wanted to continue marketing antibacterial products containing those ingredients, but very little information has been provided,” said FDA Spokesperson Tralisa Colby. “That's why the FDA issued a final rule under which over-the-counter consumer antiseptic wash products (including liquid, foam, gel hand soaps, bar soaps, and body washes) containing the majority of antibacterial active ingredients, including triclosan, will no longer be able to be marketed.”
According to Colby, the FDA ran a short-term study using animals exposed to high doses of triclosan and the result was a decrease in thyroid hormone levels. While the results have yet to be shown in humans, the overuse of triclosan still carries a risk in the form of bacterial resistance.
“The significance of these findings to human health has not been shown,” Colby said. “However, existing data raise potential concerns about the effects of repeated daily human exposure to antibacterial ingredients, such as triclosan. Other studies in bacteria have raised the possibility that exposure to triclosan contributes to making bacteria resistant to antibiotics.”
Antibiotic resistance in bacteria reduces the effectiveness of drugs and other agents designed to prevent, halt, or cure the spread of infection, according to the U.S. Centers for Disease Control and Prevention website. Bacteria highly resistant to antibiotics can quickly become a Staph infection or Methicillin-resistantStaphlococcus aureus(MRSA), causing problems such as skin infection, sepsis, pneumonia, and infections in the bloodstream.
Phasing Out Triclosan
For those working in custodial services, a time of using triclosan-free products may be coming sooner rather than later.
Since the initial proposal was made, manufacturers have already begun phasing out the use of triclosan in their consumer products. One particular hand hygiene manufacturer has not introduced a triclosan product since 2011, and has removed the ingredient from its public washroom soap products. Another company is making changes to its products beyond the United States and Canada, and has begun removing triclosan from all products in its worldwide markets to cut down on confusion for custodial services.
According to Dr. Steve Dalton, vice president in health care and infection prevention with Sealed Air Diversey Care, the full removal of triclosan frees custodians from making unnecessary decisions. For example, removing triclosan from all products will prevent janitorial businesses and staff from having to decide what product should be used where based on rulings that may apply to different service areas.
According to Dalton, full disposal of triclosan products will take time due to the current supply custodial businesses and facilities already have in their supply closets. “You could see people [continuing] to use the products because of how much was already manufactured,” Dalton said. “It can still go through the supply chain, but they'll use it up. They can [also] start to look for alternatives; there's still time.”
Currently, the FDA has no objection to retailers, suppliers, or custodial services continuing to sell or use products covered under the rulingbeforeSeptember 6, 2017. However, after this date, such products remaining on the market or in use could be subject to regulatory action, according to the agency. This means building service contractors and in-house facility managers may eventually be responsible for discontinuing use of particular hand-hygiene products in the facilities they service.
Exempt Industry Markets
Custodial workers in the medical care and food service settings will most likely continue to use triclosan products in the near future. According to the FDA, different proposals based on the categories of setting, target population, and infection risk require separate evaluations, meaning some custodial services will be using triclosan products longer than others—or until a ruling can be made for their removal.
Health Care Facilities
According to the FDA, the recent ban on triclosan will not apply to antibacterial products and antiseptics—such as sanitizing wipes, antibacterial hand sanitizers, surgical hand scrubs and rubs, and patient preoperative skin preparations—used by health care cleaning professionals. The FDA is required to issue a final ruling on the use of triclosan in antiseptic health care products by January 15, 2018.
Food Service Facilities
Similar to antiseptics used in health care, the FDA is currently evaluating the safety and effectiveness of triclosan products used in the food service industry, specifically kitchen sanitation. According to the FDA, antiseptic products used in food service will be subject to a separate future ruling decision.
Potential Health and Budget Benefits
According to Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research (CDER), manufacturers provided little evidence on the effectiveness of products with triclosan compared to traditional handwashing methods. Once new products become available to them, custodians who regularly refill restroom or other hand hygiene dispensers—in addition to other building occupants who may use antibacterial hand hygiene products—will no longer have exposure to high concentrations of triclosan.
Financially, the FDA's ruling provides building service contractors and facilities an opportunity to save a little money. For example, one company sells its bulk antibacterial soap for 5 to 10 cents more than its bulk plain soap, depending on the bulk size.
Through health regulation, company foresight, and a wide timeframe, some custodians may find themselves disposing and replacing wash products that contain triclosan. However, the long-term benefits should translate to financial savings for organizations and a safer, healthier environment for custodians and building occupants alike.