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Antibacterials:
Regulation and Policy
Updates:
Groups Tell EPA to Stop Uses of Anti-Bacterial
Consumer Products. (7/7/08) In comments to EPA on its new risk assessment
and evaluation of the widely used anti-bacterial chemical triclosan groups
point to health and environmental effects and call for end to consumer
products. Read
the press
release and comments
to EPA.
The Non-Prescription Drug Advisory Committee of the U.S.
Food and Drug Administration (FDA) issued a call for further research
regarding the risks and benefits of specific consumer antibacterial products.
(10/25/05). Read petition
and press release
Regulating
Antibacterials
In general, EPA regulates
all of the pesticidal uses of
antibacterials
when they are used as a preservative, a fungicide,
or a biocide, such as with Microban® in plastics. Articles or products
that claim to be effective in controlling microorganisms such as E.coli
etc, must be registered as a pesticide, once the product makes a public
health claim that goes beyond the use of the pesticide as a preservative
to protect the product itself.
According to the EPA,
..
"FIFRA [Federal Insecticide, Fungicide, and Rodenticide Act ]
does not allow companies to make public health pesticidal claims for any
product distributed or sold unless the product has been approved and registered
by EPA or is covered by an exemption from registration. EPA is concerned
about these claims because, in addition to being unlawful, they are also
potentially harmful to the public (e.g., if people believe that a product
has a self-sanitizing quality, they may become lax in their hygiene practices).
Practicing standard hygiene practices has been proven to prevent the transmission
of harmful microorganisms and, therefore, reduce the possibility of public
health risk."
For more information
visit EPA's Consumer
Products Treated with Pesticides
Did
you know…?
The U.S. EPA and the FDA share responsibility for regulating antimicrobial
products. If an antimicrobial product is intended for use on the
human body, it falls under the jurisdiction of FDA, rather than
EPA.
FDA
categorizes triclosan and other antimicrobial products based on
use and product claims. If a product makes a health related claim,
such as “kills germs” (soap, first aid creams, etc.),
FDA registers it as a drug. If it makes no claim at all or if its
claims are cosmetic, such as “fights odors” or “improves
skin” (deodorant, makeup, shaving cream), it is registered
as a cosmetic.
All uses not applied to the human body (bathroom and kitchen cleaners,
hospital disinfectants), that make pesticidal claims, such as “kills
bacteria and mildew” are regulated by EPA as pesticides.
In spite
of shared responsibility, the FDA and the EPA have done little to
warn consumers of the possible health and environmental effects
of triclosan. |
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