[Pharmwaste] Plain Soap As Effective As Antibacterial But Without The Risk

PDeLeo at sdahq.org PDeLeo at sdahq.org
Fri Aug 17 11:15:30 EDT 2007


Thanks for your input.

Antibacterial soaps are regulated by FDA as drugs (over-the-counter drugs).
So, FDA is responsible for evaluating the safety and efficacy of the
antibacterial ingredients, in this case Triclosan.  In it's Tentative Final
Monograph for topical antimicrobial products published in the mid-70's and
re-published in 1994, Triclosan was included.  So, FDA has tentatively
concluded that Triclosan is safe and effective, but that monograph has not
been finalized and the agency has requested additional efficacy data.
However, antibacterial soaps can be sold as such today.  Therefore, the
simple answer to your question is that the companies which manufacture
antibacterial soaps believe they are safe and effective.  If FDA concludes
that they do not meet these criteria, they will not be permitted to be sold
as such, and there is probably no marketing benefit to selling them without
being able to label them with an antibacterial claim.  Contrast that with
some deodorants which contain Triclosan but aren't marketed as such.  In
those cases, the Triclosan is effective in killing odor causing bacteria
and presumably the effectiveness of the deodorant sells itself.

On the environmental side, Triclosan is generally found in untreated
wastewater at less than 10 ug/L (parts per billion) and in treated
wastewater at less than 1 ug/L.  There have been a number of surveys of
natural waters where Triclosan has been detected.  I believe the
comprehensive USGS survey found it in about 60% of samples and the
concentrations were around 100 ng/L (parts per TRILLION) or less.  Most
chemists are using analytical methods that have a detection limit of 10-20
ng/L; with such sensitivities you can probably find just about anything
anywhere.  The most sensitive chronic no observed effect concentration I've
seen is 0.69 ug/L for an alga.  So, the margin of safety may not be high in
that case, but generally, concentrations in the environment are well below
the lowest no-effect concentration.

On the human health side, Triclosan will almost certainly be found in
humans as people are ingesting it (when the brush their teeth) and applying
it to their bodies (though soap & deodorant use).  As part of the new drug
application to FDA for use in toothpaste, the agency evaluated the long
term ingestion of Triclosan through that use and concluded that exposure at
that level, probably among the highest you would find, is safe.

Antibacterial soaps are one of a number of consumer and industrial
applications where Triclosan is used.  On the consumer side, it is found in
deodorants and toothpaste, and is formulated in to a number of materials
(e.g., textiles, cutting boards, sutures) because of it's antibacterial
properties.  On the industrial/commercial side, it is used as an additive
to cooling towers and the like to prevent growth of microorganisms in those
systems.  Point being, the antibacterial soaps represent only a portion of
the environmental load, but I do not have a breakdown of those uses.

The rhetoric on chemicals today, especially in the popular media, often
focuses on hazards without any context with regard to the likelihood of
that hazard occurring (i.e., risk).  We know Triclosan will harm aquatic
organisms at certain concentrations, but the likelihood of concentrations
in the environment occurring at a level which will harm aquatic organisms
is very low, so the risk is very low.  Unfortunately, a lot of people
believe that synthetic chemicals should not be found in the natural
environment or the human body at any level, and it is not really possible
to make a convincing argument in that case based on risk.

Paul DeLeo

Paul C. DeLeo, PhD.
Director, Environmental Safety
The Soap and Detergent Association
1500 K Street, N.W., Suite 300
Washington, DC 20005
(202) 662-2516 - voice
(202) 347-4110 - FAX
pdeleo at sdahq.org

             Pete Pasterz                                                  
             <PAPasterz at cabarr                                             
             uscounty.us>                                               To 
                                       "PDeLeo at sdahq.org"                  
             08/16/2007 02:43          <PDeLeo at sdahq.org>,                 
             PM                        "DeBiasi,Deborah"                   
                                       <dldebiasi at deq.virginia.gov>        
                                       "pharmwaste-bounces at lists.dep.state 
                                       <pharmwaste-bounces at lists.dep.state 
                                       "pharmwaste at lists.dep.state.fl.us"  
                                       <pharmwaste at lists.dep.state.fl.us>  
                                       RE: [text][heur] Re: [Pharmwaste]   
                                       Plain Soap As Effective As          
                                       Antibacterial ButWithout The Risk   

I think what you're missing is that if indeed plain soaps [which I
assume members of your trade group also make] are AS effective in in
preventing disease as anti-bacterial soaps [which you did not dispute],
and if there is, at least a theoretical possibility of antibiotic
resistance as observed in laboratory conditions [which you also do not
dispute]--WHY would your industry use them, and take the chance that
there MIGHT be some effect in the community setting?  Yes, it's been
used since the 1960's...but sparingly compared to the 70% of all soaps,
plus myriad other products like cosmetics and toothpaste it is in now.

What is the purpose of adding an ingredient to a product which has no
effectiveness in its stated purpose for inclusion, though may have
yet-to-be discovered negative environmental/health implications?  What
dollar cost to the product is there from adding triclosan? What is the
cost/benefit of that?

>From an ecotoxicological point of view, what are the benefits of
triclosan in the environment, since some studies seem to show it to be
one of the most frequently detected compounds in surface water systems,
is toxic to algae, that it bioaccumulates in wildlife [and thus in
humans], and that it may form dioxins when it degrades?

Pete Pasterz

-----Original Message-----
From: pharmwaste-bounces at lists.dep.state.fl.us
[mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of
PDeLeo at sdahq.org
Sent: Thursday, August 16, 2007 1:48 PM
To: DeBiasi,Deborah
Cc: pharmwaste-bounces at lists.dep.state.fl.us;
pharmwaste at lists.dep.state.fl.us
Subject: [text][heur] Re: [Pharmwaste] Plain Soap As Effective As
Antibacterial ButWithout The Risk

I would like to reply to this posting with the caveat that I represent
the industry that manufactures antibacterial soaps.

The authors state that they wish to compare the potential hazards versus
benefits of antibacterial soaps, in particular those containing
They state the hazard is the potential emergence of antibiotic
They cite eleven studies where cross-resistance to antibiotics was
observed among laboratory cultures exposed to Triclosan.  Yes, this kind
of research has been conducted for more than a decade and is useful in
defining the scope of the safety of these products.  However, the next
step would be to see whether the laboratory phenomenon is observed when
the products are actually used.  The authors cite two community-level
studies, one by Eugene Cole and one conducted by themselves.  They state
"Neither of these studies demonstrated the emergence of antibiotic
resistance associated with the use, over a 1-year period, of the liquid
hand soap containing 0.2% triclosan compared to plain soap."  So what am
I missing?  By their own research they have concluded there is no such
hazard (antibiotic cross-resistance).  In fact they go on to point out a
number of reasons why the effect was observed in the laboratory setting
and not in the community setting (e.g., the lab experiments used a very
low, selective concentration).  Finally, they point out that "Consumer
hygiene products containing triclosan have been used since the
1960s...".  There has been no evidence that the use of Triclosan in
antibacterial soaps has contributed to antibiotic resistance.  Contrast
that with the use of sub-theraputic doses of fluoroquinolones in poultry
production which was determined to lead to antibiotic resistance among
pathogens in poultry; that use was banned by FDA in 2005 (or more
accurately, the drug approval was withdrawn).

I think it is significant to note that Drs. Aiello, Larson and Levy
(especially Dr. Levy) have been among the foremost advocates for the
prevention of bacterial resistance to antibiotics.  Their advocacy
usually focuses on those activities which are known to lead to
antibiotic resistance, namely the overuse and misuse of antibiotics in
humans (e.g., prescription of an antibiotic for a cold), and the
inappropriate use of antibiotics in agriculture.

Paul DeLeo

Paul C. DeLeo, PhD.
Director, Environmental Safety
The Soap and Detergent Association
1500 K Street, N.W., Suite 300
Washington, DC 20005
(202) 662-2516 - voice
(202) 347-4110 - FAX
pdeleo at sdahq.org


             <dldebiasi at deq.vi

             Sent by:
<pharmwaste at lists.dep.state.fl.us>
             s at lists.dep.state

                                       [Pharmwaste] Plain Soap As

                                       Effective As Antibacterial But

             08/16/2007 10:47          Without     The Risk



Source: University of Michigan

Date: August 16, 2007

Plain Soap As Effective As Antibacterial But Without The Risk

Science Daily - Antibacterial soaps show no health benefits over plain
soaps and, in fact, may render some common antibiotics less effective,
says a University of Michigan public health professor.

In the first known comprehensive analysis of whether antibacterial soaps
work better than plain soaps, Allison Aiello of the U-M School of Public
Health and her team found that washing hands with an antibacterial soap
was no more effective in preventing infectious illness than plain soap.
Moreover, antibacterial soaps at formulations sold to the public do not
remove any more bacteria from the hands during washing than plain soaps.

Because of the way the main active ingredient---triclosan---in many
antibacterial soaps reacts in the cells, it may cause some bacteria to
become resistant to commonly used drugs such as amoxicillin, the
researchers say. These changes have not been detected at the population
level, but e-coli bacteria bugs adapted in lab experiments showed
resistance when exposed to as much as 0.1 percent wt/vol triclosan soap.

"What we are saying is that these e-coli could survive in the
concentrations that we use in our (consumer formulated) antibacterial
soaps," Aiello said. "What it means for consumers is that we need to be
aware of what's in the products. The soaps containing triclosan used in
the community setting are no more effective than plain soap at
preventing infectious illness symptoms, as well as reducing bacteria on
the hands."

The study, "Consumer Antibacterial Soaps: Effective or Just Risky""
appears in the August edition of Clinical Infectious Diseases. The team
looked at 27 studies conducted between 1980 and 2006, and found that
soaps containing triclosan within the range of concentrations commonly
used in the community setting (0.1 to 0.45 percent wt/vol) were no more
effective than plain soaps. Triclosan is used in higher concentrations
in hospitals and other clinical settings, and may be more effective at
reducing illness and bacteria.

Triclosan works by targeting a biochemical pathway in the bacteria that
allows the bacteria to keep its cell wall intact. Because of the way
triclosan kills the bacteria, mutations can happen at the targeted site.
Aiello says a mutation could mean that the triclosan can no longer get
to the target site to kill the bacteria because the bacteria and the
pathway have changed form.

The analysis concludes that government regulators should evaluate
antibacterial product claims and advertising, and further studies are
encouraged. The FDA does not formally regulate the levels of triclosan
used in consumer products.

Other antiseptic products on the market contain different active
ingredients, such as the alcohol in hand sanitizers or the bleach in
some antibacterial household cleaners. Aiello's team did not study those
products and those ingredients are not at issue.

Note: This story has been adapted from a news release issued by
University of Michigan.

Deborah L. DeBiasi
Email:   dldebiasi at deq.virginia.gov
WEB site address:  www.deq.virginia.gov
Virginia Department of Environmental Quality Office of Water Permit
Programs Industrial Pretreatment/Toxics Management Program
Mail:          P.O. Box 1105, Richmond, VA  23218 (NEW!)
Location:  629 E. Main Street, Richmond, VA  23219
PH:         804-698-4028
FAX:      804-698-4032

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