I won't keep boring you with these long posts, but ServiceMaster appears to be a potential client for this disinfectant:
December 17, 1993
Ms. Patricia K. Clark, Director
Directorate of Compliance Affairs
Occupational Safety and Health Administration
U.S. Department of Labor
200 Constitution Avenue, N.W.
Washington, DC 20210
Re: OSHA Bloodborne Pathogens Standard, 29 CFR 1910.1030,
Tuberculocidal Disinfectant
Dear Ms. Clark:
The OSHA requirement for the use of a tuberculocidal disinfectant
for the decontamination of blood and other potentially infectious
materials (OPIM), as set forth in OSHA Instruction CPL 2-2.44C,
March 6, 1992, has created serious problems from both the
operational and regulatory viewpoints.
ServiceMaster provides housekeeping/custodial services to
thousands of health care facilities, schools, and commercial and
industrial facilities nationwide through our management services
companies. In addition, the ServiceMaster franchise network
provides similar services to thousands of industrial, commercial,
and residential facilities nationwide. Many of these thousands
of facilities require the cleanup of blood or OPIM on either a
regular or sporadic basis. The use of either a 1:10 or 1:100
dilution of bleach (5.25% sodium hypochlorite solution) is not
appropriate or desirable in most applications. The use of a
tuberculocidal disinfectant has imposed serious problems and
limitations for both our management services and our franchise
licensees.
At present, their are two classes of disinfectant-detergent
products that are appropriate for use in housekeeping-type
cleaning and decontamination. The quaternary ammonium compound
combined disinfectant-detergents and the phenolic compound
combined disinfectant detergents are used for this type of
application. Iodophor disinfectant-detergents are not
appropriate for general application to environmental surfaces.
For more than thirty years, we have preferred to use a quaternary
ammonium compound disinfectant-detergent for our housekeeping-
type applications in health care facilities and elsewhere for
several reasons. First, the "quats" are acknowledged to be
superior cleaning agents. The enclosed letter to the American
Hospital Association from Dr. Martin Favero of the Centers for
Disease Control and Prevention (CDC) emphasizes the long-standing
CDC position that the physical removal of contaminants by
cleaning is as important, if not more so, than any antimicrobial
effect of the antimicrobial agent used. Quats are ideal for this
essential cleaning. In addition, quats provide better
cleanability than phenolic disinfectant-detergents. Bleach
provides no more cleanability than plain water. Furthermore,
there are other important considerations. Routine use of
phenolic products is detrimental to floor finish and floors must
be refinished more frequently with phenolic use than with quat
use. From the operational consideration, this increased
frequency of floor refinishing is much more labor-intensive and
expensive than the frequency required when quats are used. This
is very important in the cost-reduction climate that we live in
today.
Phenolics are also more toxic than quats. Phenolics can cause
skin depigmentation and even though barrier precautions should be
observed, i.e., the use of gloves, the potential for skin
depigmentation remains. The American Academy of Pediatrics and
the American College of Obstetricians and Gynecologists recommend
that only quat or iodophor disinfectants be used on surfaces that
will contact the newborn infant. Phenolics are not recommended
for this purpose because the use of phenolics has been associated
with hyperbilirubinemia in exposed infants.
Phenolic use is also banned in some geographical areas, including
the entire state of Arizona, because it will not be allowed in
waste water that will end up in surface waters that are used as a
public drinking water source. Therefore, quats are the only
alternative in some geographical areas, as well as in many
children's hospitals and newborn nurseries.
Phenolic disinfectant formulations are generally tuberculocidal.
Unfortunately, most quaternary ammonium formulations are not
tuberculocidal. There are several tuberculocidal quaternary
ammonium compound disinfectants on the market that are supplied
in a ready-to-use solution. These disinfectants are
tuberculocidal by virtue of their relatively high concentrations
of quats. However, they are not combined disinfectant-detergents
and their use in housekeeping-type activities is not practical
from the cleanability viewpoint and because of the relatively
large areas that must be cleaned and decontaminated. At present,
there is only one quat disinfectant-detergent on the U.S. market
that can be used where a tuberculocidal quat is required.
ServiceMaster supplies its own non-tuberculocidal quat and
tuberculocidal phenolic disinfectant-detergent products. However,
where a tuberculocidal quat disinfectant-detergent is needed, we
must use the only product on the market. This is both more
difficult for the user from the ordering, cost, and supply viewpoint
and it is also an infringement on free trade.
All available information indicates that the requirement to use a
quat disinfectant-detergent for housekeeping activities, even
where blood is present, is unnecessary and represents gross
overkill. Dr. Favero discusses the use of non-tuberculocidal
disinfectant-detergents in his letter to the AHA and in
previously published reports.
Dr. Favero has been a foremost authority on hepatitis B virus
(HBV) decontamination for two decades and speaks from both
scientific and epidemiologic knowledge bases. In addition, HBV
is known to be very sensitive to disinfectants, contrary to the
general belief that has persisted for years. While HBV cannot be
grown in the laboratory to test disinfectants, there have been in
vivo studies using chimpanzees. HBV disinfection data was
gathered years ago by Dr. Favero and co-workers at the old CDC
Phoenix Laboratories. More recently, Gibraltar Laboratories
developed a chimpanzee-model protocol in an attempt to establish
an EPA-recognized HBV test. Results showed that quats will
inactivate HBV. In view of evidence to the contrary, a
tuberculocidal agent is not needed to inactivate HBV. And as Dr.
Favero and CDC recommendations and guidelines point out,
"Environmental surfaces such as walls, floors, and other surfaces
are not associated with transmission of infections to patients or
health-care workers" (MMWR, Vol. 36, No. 2S,
August 21, 1987).
There is a major regulatory issue involved with the use of a
tuberculocidal agent to decontaminate blood spills on carpet.
Bleach can only be used on solution-dyed carpet, so it cannot be
used with most installed carpet. All EPA-registered
tuberculocidal agents are intended for use on hard, nonporous
surfaces, as stated on the labels. There is also a label
statement which states that "It is a violation of Federal law to
use this product in a manner inconsistent with its labeling." In
order to satisfy the OSHA requirement to decontaminate blood
spills using a tuberculocidal agent, we must violate Federal law,
i.e., the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) under which disinfectants are registered with the EPA.
If we don't use a tuberculocidal agent on the carpet, we violate
OSHA requirements and if we do use a tuberculocide, we violate
Federal law. This puts on the proverbial horns of a dilemma.
The language of the Bloodborne Pathogen Standard leaves some
latitude for making an informed decision about decontamination
choices, (d)(4)(i), but the compliance document removes any such
realistic decision-making capability and gives us no option but
to break the law.
For years before the emergence of HIV and the OSHA Bloodborne
Pathogens Standard, we were decontaminating carpets that were
contaminated with blood by thorough cleaning and removal of any
blood-containing material. Standard carpet extraction procedures
used to clean carpet were sufficient for such decontamination for
years without there ever being any transmission of HBV in the
health care setting or elsewhere. If there had been any
epidemiologic correlation between this carpet decontamination
procedure and HBV transmission, I am sure that I would have heard
of it in my nineteen years with ServiceMaster. Since
ServiceMaster cleans more carpet than anyone else in the world,
about five million square feet per day, there is a large data
base under consideration.
In view of the points discussed above, there needs to be some
relaxation of the requirement to use a tuberculocidal
disinfectant in housekeeping/custodial-type cleaning and
decontamination procedures. This applies both to the allowance
of EPA registered non-tuberculocidal disinfectant-detergents that
are active against HIV and to the decontamination of carpet. We
do not want to continue violating Federal law for carpet
decontamination nor do we want to be limited to one product to
satisfy our needs for hard surface decontamination.
We realize the reason for OSHA's position, but we feel that the
opinions of the disease prevention experts should also be
considered, i.e., the CDC and infection control professionals.
Please consider the need for modifying the compliance document to
be more consistent with the language in the standard itself and
with sound epidemiologic principles.
We would appreciate a decision from your national level rather
than a regional level since we operate in all ten OSHA regions
and in all fifty states.
If you think that it would be advantageous for us to visit with
you or your representative at your office to further discuss this
matter, we would be happy to meet with you in Washington at your
earliest convenience. If there are any questions, please don't
hesitate to call upon me.
Sincerely,
Edward A. Schmidt, MPH, CIC
Environmental Microbiologist/
Environmental Sanitarian
Infection Control Practitioner |
