In this week's "Issues of the Environment," WEMU's David Fair speaks to Melissa Cooper-Sargent, Green Living Resources Director for the Ecology Center, about the environmental and health risks of using antibacterial soap.
* Local stores will soon no longer sell common antibacterial soaps containing triclosan. Triclosan is the most commonly used active ingredient in antibacterial products, of which there are thousands.
* The FDA recently ruled that triclosan and similar compounds likely do more harm than good and banned the sale of soaps that contained them. Manufacturers failed to demonstrate that the triclosan-containing products were more effective than plain soap and water, and there is mounting evidence that triclosan is a health hazard leading to antibiotic-resistant strains of bacteria and that it causes endocrine disruption, neurological effects, and possibly liver cancer. The deadline for ending manufacture is September 2017.
* The banned substances have also been found to damage wildlife, and they have been detected in our local waterways and the Great Lakes.
* These products are intended for use with water and are rinsed off after use. For now, the FDA ban does not affect consumer hand “sanitizers” or wipes, or antibacterial products used in health care settings.
* Melissa Cooper Sargent, Green Living Resources Director for the Ecology Center, says that consumers should wash hands with “plain soap and water,” which is just as effective as the banned substances and far safer.
Soon, shoppers in southeast Michigan will no longer be find anti-bacterial soaps on local store shelves as an FDA ban has begun to take effect. Certain ingredients that are common in antibacterial hand and body soaps are no longer allowed. The U.S. Food and Drug Administration (FDA) announced [recently] that ingredients including triclosan [liquid soaps] and triclocarban [bar soaps]—which have long raised safety concerns because they have been linked to hormone disruption, bacterial resistance, and even possibly liver cancer—will no longer be allowed. The agency released its long-awaited final ruling on the issue, and said in a statement that companies can no longer market their antibacterial hand and body washes if they contained these ingredients. That's because "manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections."
How many times a day do doctors wash their hands? Dozens, perhaps. And they encourage us to follow effective hand-washing techniques as well. “But, the conversation shouldn’t end there,” according to Dr. Paula Kim, MD with Beaumont Health System, clinical professor at Wayne State University’s School of Medicine, and associate professor at Oakland University William Beaumont School of Medicine. She says, “The next questions are: What type of soap is used at home? Is it an antibacterial? Or is it plain soap and water?”
The Centers for Disease Control, American Medical Association, Food and Drug Administration, and others overwhelmingly encourage people to use non-antibacterial (plain) soap, warm water and to rub hands together for a minimum of 20 - 30 seconds.
Why plain soap? Isn’t an antibacterial product more effective? In 2013, the FDA challenged manufacturers of antibacterial hand and body soaps (which are Over the Counter drugs) to prove that their products are more effective at killing germs than plain soap and water. And they couldn’t do it. “There’s no data demonstrating that these drugs provide additional protection from diseases and infections. Using these products might give people a false sense of security,” says Theresa M. Michele, MD, of the FDA’s Division of Nonprescription Drug Products.
In fact, this past September, the FDA issued a rule banning manufacturers from using nineteen different antibacterial active ingredients, including the widely-used triclosan. The agency cited health risks, including bacterial resistance, as a main concern. Manufacturers of hand and body soaps (soaps intended to be used with water) have until September 2017 to switch their formulations. The new rule affects the majority of liquid hand soaps and bar soaps currently on the market. It does not affect hand sanitizers or hand wipes.
According to the FDA, “...laboratory studies have raised the possibility that triclosan contributes to making bacteria resistant to antibiotics. Some data shows this resistance may have a significant impact on the effectiveness of medical treatments, such as antibiotics.” The FDA has also expressed concern over triclosan’s potential hormonal effects. According to the FDA, “...recent studies have demonstrated that triclosan showed effects on the thyroid, estrogen, and testosterone systems in several animal species, including mammals, the implications of which on human health, especially for children, are still not well understood.”
A 2014 report, "Chemicals in Consumer Products Are Draining Trouble into the Great Lakes Ecosystem," published by the Canadian Environmental Law Association (CELA), found--in addition to concerns about endocrine activity--triclosan carries moderate risks for reproductive toxicity, developmental neurotoxicity, neurotoxicity (a single dose), and human systemic toxicity (repeated dosage).
Triclosan is the most commonly used active ingredient in antibacterial products, of which there are thousands. It is added to household cleaners, cosmetics (including soap, deodorant, toothpaste, and mouthwash), clothing, furniture, lunchboxes, backpacks, food packaging, kitchen utensils, children’s toys, and more. But, it doesn’t stay in those products. Researchers have detected triclosan in household dust, in streams and other waterways, in wildlife, in human plasma and breast milk, and in drinking water. Indeed the multitude of exposure paths was a driving factor behind the FDA’s original request for safety and efficacy data from manufacturers. According to a September 2016 FDA Consumer Update fact sheet, "Antibacterials? You Can Skip It--Use Plain Soap and Water," “...people’s long-term exposure to triclosan is higher than previously thought, raising concerns about the potential risks associated with the use of this ingredient over a lifetime.”
Much of the triclosan washed down the drain ultimately finds its way to our local waterways, since wastewater treatment plants are not equipped to filter out the chemical. CELA’s 2014 report found 90% of surface water sampled in the Great Lakes is contaminated with triclosan. They label triclosan “a chemical to be avoided” due in part to the very high risk of aquatic toxicity and its persistence in the environment. Once triclosan-laced wastewater is discharged into local waterways, it reacts with sunlight to form dioxins, which can produce a spectrum of toxic health effects.
Many people use antibacterial soaps without knowing they are using an OTC drug. Shoppers should watch out for the word “antibacterial” or the phrase “kills germs.” Generally, we find these words and phrases reassuring. But, remind patients that it is not necessary to kill all the germs, but to simply remove them with plain soap and water. Then wash them down the drain. A Drug Facts label on a soap or body wash is a sign a product contains antibacterial ingredients. As Dr. Kim always encourages her patients, “Read the label on anything you buy. Read what’s in it!”
You don’t have to settle for toxic triclosan in your household cleaners either. Dr. Kim suggests her patients to, “Use natural things if possible, such as vinegar and water.” White vinegar is a food-grade antimicrobial which can kill germs on surfaces. Or, look for CleanWell brand soaps and sanitizers, which use thyme oil as the active ingredient to kill germs. Some of the Seventh Generation brand cleaning products include the CleanWell technology also.
Health care professionals and nursing home staff may be exposed to triclosan hundreds of times a day through the use of hand sanitizers, and the FDA is still investigating whether the potential for harm outweighs the benefits in health care settings. For now, the banned substances are allowed in sanitizers that are not rinsed off with water.
In late 2016, the U.S. Food and Drug Administration issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in topical consumer antiseptic rubs (including hand sanitizers) marketed over-the-counter (OTC). The FDA’s request for more data is intended to help the agency ensure that regular use of these products does not present unknown safety and efficacy concerns and does not mean the FDA believes these products are ineffective or unsafe.
Antiseptic rubs are products that are intended to be used by consumers when soap and water are not available, and are left on and not rinsed off with water. Millions of Americans use antiseptic rubs daily, sometimes multiple times a day, to help reduce bacteria on their hands. “Today, consumers are using antiseptic rubs more frequently at home, work, school and in other public settings where the risk of infection is relatively low,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “These products provide a convenient alternative when hand washing with plain soap and water is unavailable, but it’s our responsibility to determine whether these products are safe and effective so that consumers can be confident when using them on themselves and their families multiple times a day. To do that, we must fill the gaps in scientific data on certain active ingredients.”
The CDC advises that washing hands with plain soap and running water is one of the most important steps consumers can take to avoid getting sick and to prevent spreading infections to others. If soap and water are not available, the CDC recommends using an alcohol-based hand sanitizer that contains at least 60 percent alcohol. Based on new scientific information and input of outside scientific and medical experts on an independent advisory committee, the agency is requesting additional scientific data to demonstrate that the active ingredients used in consumer antiseptic rubs are generally recognized as safe and effective to reduce bacteria on skin. The agency is requesting manufacturers provide data for three active ingredients -- alcohol (ethanol or ethyl alcohol), isopropyl alcohol, and benzalkonium chloride. Since 2009, 90 percent of all consumer antiseptic rubs use ethanol or ethyl alcohol as their active ingredient.
The proposed rule does not require any consumer hand sanitizer products to be removed from the market at this time. Instead, it requires manufacturers who want to continue marketing these products under the OTC Drug Review to provide the FDA with additional data on the active ingredients’ safety and effectiveness, including data to evaluate absorption.
Since the FDA began review of topical antiseptics in the 1970s, many things have changed, including the frequency of use of some of these products, new technology that can detect low levels of antiseptics in the body, and the FDA’s safety standards and the scientific knowledge about the impact of widespread antiseptic use. The proposed rule seeks to ensure that the agency’s safety and effectiveness evaluations and determinations for these consumer antiseptic rub active ingredients are consistent, up-to-date and appropriately reflect current scientific knowledge and increasing use patterns.
The FDA is particularly interested in gathering additional data on the long-term safety of daily, repeated exposure to these ingredients by consumers, and on the use of these products by certain populations, including pregnant women and children, for which topical absorption of the active ingredients may be important. Emerging science also suggests that for some antiseptic active ingredients, systemic exposure (full body exposure as shown by detection of antiseptic ingredients in the blood or urine) is higher than previously thought, and that more information is needed about the effects of repeated daily human exposure to some antiseptic active ingredients.
You may not have heard of triclosan, but washing your hands with Dial anti-bacterial soap or brushing your teeth with Colgate Total is likely polluting Lake Erie and Lake Ontario with the chemical. Scientists remain unsure about the scope of the problem because they lack local data. But samples from Lake Superior show a troubling trend: Popular antimicrobial personal products are washing down the drains of our sinks and bathtubs into the Great Lakes. Once there, the chemicals triclosan and triclocarban damage freshwater ecosystems, some scientists say. The chemicals disrupt the aquatic food chain, increasing resistant bacteria, creating toxic dioxins and contaminating marine life.
“Is triclosan making its way into the system? The answer is almost certainly,” said Bill Arnold, a professor of civil, environmental and geo-engineering at the University of Minnesota. Arnold co-wrote a seminal paper on the issue in late 2013 about triclosan in Lake Superior and several inland lakes.
A 2010 joint government and industry study into emerging chemicals in the Great Lakes revealed triclosan to be among the personal care products “most frequently detected in Great Lakes waters.” Researchers detected the chemical in nearly 90 percent of surface water samples from the Great Lakes basin, according to the study.
Another study confirmed triclosan to be “highly toxic to algae,” which is essential to the aquatic food chain. The chemical also affects reproduction and development in some fish species, including rainbow trout. “Given the population densities on the other Great Lakes relative to Lake Superior, there would likely be a higher concentration in those other lakes,” Arnold said. “That’s a perfectly logical leap.”
Wastewater plant operators consider triclosan, along with microbeads and pharmaceuticals, as “contaminants of emerging concern,” said Joseph L. Fiegl, deputy commissioner of the Erie County Division of Sewerage Management. But local wastewater plants are not required to test for and remove triclosan – unlike phosphorus, nitrogen and ammonia among other chemicals.
On store shelves
Consumers who perceive antimicrobial products to be healthier and better at fighting germs spend an estimated $1 billion a year in the U.S. on antibacterial products containing triclosan. That’s resulted in a higher use of these chemicals.
ACI is a trade association representing the $30 billion U.S. cleaning products industry. ACI members include the formulators of soaps, detergents, and general cleaning products used in household, commercial, industrial and institutional settings; companies that supply ingredients and finished packaging for these products; and oleochemical producers.
The American Cleaning Institute (ACI) appreciates this opportunity to provide comments on the proposed rule to amend the 1994 tentative final monograph (the 1994 TFM) for over-the-counter (OTC) antiseptic drug products to establish conditions under which OTC consumer antiseptic products intended for use with water (referred to throughout as consumer antiseptic washes) are generally recognized as safe and effective.
ACI has a specific interest in triclosan (TCS) within the proposed rule since our members produce consumer antiseptic wash products containing triclosan and manufacture triclosan. Triclosan-containing consumer antiseptic wash products play a beneficial role in the daily hygiene routines of millions of people throughout the U.S. and worldwide. They have been and are used safely and effectively in homes, hospitals, schools and workplaces every single day. Furthermore, triclosan and products containing it are regulated by a number of governmental bodies around the world and have a long track record of human and environmental safety which is supported by a multitude of science-based, transparent risk analyses.
ACI members are concerned that FDA has not appropriately assessed the safety data that are available prior to proposing that additional safety data are necessary to support the safety of triclosan for this use. According to the agency’s proposed rule, triclosan is the most studied active ingredient for OTC antiseptic use for both safety and efficacy. FDA, however, neglected a substantial amount of relevant information beyond what is reported in the notice. Studies related to the safety and efficacy of triclosan are cited and described in these comments.
The following summarizes our response to the points raised in the proposed rule and the attachment provides detailed comments on these points.
1. The extensive triclosan database on absorption, distribution, metabolism and excretion (ADME) has demonstrated similarities in absorption, distribution, metabolism (ADM) between species as well as differences in excretion. This is especially relevant in that hamster data is sufficiently similar to human data, therefore, justifying extrapolation with minimal allometric scaling. These data remove the necessity of additional testing. Metabolism is similar following oral and dermal exposures.
2. In vivo carcinogenicity studies in three species (hamster, rat, mouse) additionally supported by extensive in vitro and in vivo mutagenicity studies demonstrate that triclosan is not a carcinogen based on assessments by both FDA and EPA.
3. Based on the above information, the ongoing dermal carcinogenicity study is not necessary. Concern about triclosan dermal photolysis to “dioxins” does not take into consideration that the most likely photolysis product, 2,8-dichlorobenzodioxin, is considered toxicologically inert based on the recognized toxicology equivalence factor (TEF) concept.
4. Extensive in vivo studies demonstrate that triclosan exhibits reproductive no observable effect levels (NOELs) that provide a wide margin of safety to humans under existing use conditions.
5. The existing database of in vitro, in vivo animal, and human studies does not support a conclusion that triclosan causes hormonal effects in humans at actual relevant exposure concentrations. The reports of high throughput screening and animal studies showing thyroid or other hormonal activity demonstrated both effect and no-effect levels as expected in adequately designed studies. Extrapolation of these findings, based on dose and relevance of effect, provides a wide margin of safety to humans.
6. The clinical evaluation of actual real-life antimicrobial (antiseptic) resistance has conclusively demonstrated no relevant association between triclosan exposure and microbial resistance to antibiotics.
7. The proposed new FDA standard of demonstrating efficacy by use of clinical population studies is inherently flawed. It requires an infection/disease reduction standard that is not necessary. As long as FDA accepts that antimicrobials (antiseptics) have been adequately shown to have the ability to decrease bacterial (or other relevant organisms) populations, it can control usage by limiting claims. The new standard assumes a claim that would be the exception rather than the rule. Only those wishing this exception would have to meet the clinical population standard. This differentiation would allow FDA to meet their standards for efficacy and safety within a reasonable timeline. Triclosan has demonstrated both in vitro and in vivo efficacy utilizing formulations that have demonstrated infection control in clinical situations and dermal bacterial reduction in consumer settings.
Regarding efficacy testing, FDA should reconsider the new efficacy testing requirements presented in its proposed rule, which are unprecedented. Given the significance of the proposed change to the testing requirements for Consumer Antiseptics and the lack of precedent for this action, FDA should withdraw the proposed rule and reissue it as an Advance Notice of Proposed Rulemaking (ANPR) to give industry and other stakeholders an opportunity to engage with FDA on the generally recognized as effective (GRAE) testing requirements for the active ingredients and surrogate endpoint testing of final formulations. FDA’s efficacy requirements are unjustified by the risk-benefit analysis.
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