In July, 2016, our article entitled, “Triclosan? Just Wash Your Hands!” appeared in Keystone Water Quality Manager Magazine. At that time, we reported that indicators and research pointed to a minimal risk to humans of the trace amounts of triclosan found in land-applied biosolids. We also noted that, since such anti-microbial compounds provided no additional benefit to the consumer over washing with plain soap and water, these active ingredients could be removed from products such as antibacterial wash products without putting the safety of the general public at risk.
A couple months later, the FDA reached a similar conclusion when they released their findings that companies could not prove that the inclusion of such ingredients in consumer wash products provided better protection against spreading certain infections and preventing illness than diligent hand washing alone. In September, 2016, the FDA issued a final ruling that over-the-counter (OTC), anti-bacterial wash products that contain one or more of 19 specific active ingredients, including triclosan, will no longer be able to be marketed. This only applies to those products that are intended to be used with water and rinsed off. It does not affect consumer hand “sanitizers” or wipes, or antibacterial products used in hospital and food service settings. Manufacturers will have one year to comply by either reformulating or removing the products from the market.
This ruling by the FDA is a follow-up to their proposed rule in 2013 when data showed that long-term exposure to these active ingredients could pose minimal health risks, including bacterial resistance and hormonal effects. The new ruling concludes that, since there is no benefit to including the ingredients – and, in fact, there is a slight negative health risk – there is no need to use them at all. The Centers for Disease Control recommends that, if soap and water are not available, consumers should use an alcohol-based hand sanitizer instead. Other ingredients that have shown anti-bacterial properties in alternative products include hydrogen peroxide, thyme oil, and citric acid.
The FDA has deferred ruling on three other ingredients used in consumer antiseptic wash products until more safety and effectiveness data is submitted. The three ingredients are: benzalkonium chloride, benzethonium chloride and chloroxyleno (PCMX).
All of this is good news for the biosolids sector. Eliminating potentially harmful ingredients in the manufacturing of consumer products will subsequently reduce their presence in biosolids and thus reduce the risk and public anxiety over the presence of these microconstituent contaminants in the future.
The 19 banned ingredients are:
- Iodophors, which are iodine-containing ingredients
- Iodine complex, which is ammonium ether sulfate and polyoxyethylene sorbitan monolaurate
- Iodine complex of phosphate ester of alkylaryloxy polyethylene glycol
- Nonylphenoxypoly, or ethyleneoxy, ethanoliodine
- Poloxamer, an iodine complex of Povidone-iodine 5 percent to 10 percent
- Undecoylium chloride iodine complex
- Methylbenzethonium chloride
- Phenol greater than 1.5 percent
- Phenol less than 1.5 percent
- Secondary amyltricresols
- Sodium oxychlorosene
- Triple dye