Standard Interpretations - (Archived) Table of Contents|
| Standard Number:||1910.1030|
May 6, 1994
Edward A Schmidt, MPH, CIC
The ServiceMaster Company
One ServiceMaster Way
Downers Grove, Illinois 60515-1700
Dear Mr. Schmidt:
This is in response to your letter of December 17, 1993, requesting clarification of the Occupational Safety and Health Administration (OSHA) regulation 29 CFR 1910.1030, "Occupational Exposure to Bloodborne Pathogens." We apologize for the delay in this response. We also thank you for forwarding your decontamination/disinfection information to our staff for review.
Specifically, you inquired about decontamination of plush carpet and hard surfaces after a Blood or other potentially infectious material (OPIM) spill has occurred. Under 29 CFR 1910.1030(d)(4)(ii), OSHA requires that equipment and surfaces be cleaned and disinfected after contact with blood or OPMI. It is the employer's responsibility to determine and implement an appropriate written schedule for cleaning and the method of decontamination based on the location within a facility, the type of surface to be cleaned, the type of spill present and the tasks or procedures being performed in the area.
Paragraph 29 CFR 1910.1030(d)(4)(ii)(A) states that "...an appropriate disinfectant..." shall be used for decontamination of work surfaces contaminated with blood or OPIM. The current OSHA policy regarding acceptability of disinfectants used for this purpose is stated in the Inspection and Citation Guidelines following paragraph M.d.(1)(b) on page 34 of OSHA Instruction CPL 2-2.44C, "Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens Standard, 29 CFR 1910.1030." This policy indicates that products registered with the U.S. Environmental Protection Agency (EPA) with claims of tuberculocidal efficacy are considered "appropriate" for purposes of compliance with the standard, and would therefore be acceptable for such use. OSHA recognized EPA-registered tuberculocidal disinfectants as acceptable for decontamination as well as bleach diluted between 1:10 or 1:100 with water. The OSHA policy to require use of tuberculocidal disinfectants has remained the same for hard surfaces. OSHA continues to require the use of a tuberculocidal disinfectant to clean up blood or body fluids. The use of quaternary ammonium compounds which have not been registered with EPA as tuberculocidal germicides is appropriate for housekeeping procedures which do not involve the clean-up of contaminated (defined as the presence or reasonably anticipated presence of blood or OPIM) surfaces. For surfaces contaminated with blood or OPIM, you should note that there are some quaternary ammonium compounds which are registered with EPA as tuberculocidal germicides. For a complete listing of such germicides, you can call Texas Technical University on (800) 438-4318. The University has a contract with EPA to answer questions related to the germicidal list.
Regarding your concern for carpet decontamination, OSHA does not have any evidence to support whether decontamination of plush carpets is possible; it is our opinion that carpeted surfaces cannot be decontaminated. However, under normal circumstances, carpeted surfaces are located in areas where there is minimal exposure from dermal contact, therefore, employers are expected to make a reasonable effort to clean and sanitize carpeting and soft plush surfaces with carpet detergent/cleaner products.
We hope this information is responsive to your concerns and thank you for your interest in safety and health.
H. Berrien Zettler, Deputy Director
Directorate of Compliance Programs
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.
Edward A. Schmidt, MPH, CIC
Infection Control Practitioner
cc: Dr. William C. Bond, Vice President,
September 3, 1993
Ms. Gina Pugliese, RN, MS
Director of Infection Control and
American Hospital Association
840 N. Lake Shore Drive
Chicago, Illinois 60611
During our telephone conversation yesterday, you indicated that you have received a number of questions concerning the use of chemical germicides for decontaminating blood spills in health care facilities as well as questions on the use of specific EPA approved products for housekeeping purposes. You also indicated that there seems to be an inappropriate interpretation of the Centers for Disease Control and Prevention (CDC) recommendations in this area.
We have also received questions of this type and have emphasized a number of points that were contained in the CDC publication "Recommendations for the Prevention of HIV Transmission in Health-Care Settings." which was published in the Morbidity and Mortality Weekly Report of August 21, 1987. There are several sections in that report under "Environmental Consideration for HIV Transmission" that discuss disinfection, sterilization, and housekeeping strategies. It is pointed out that environmental surfaces such as walls, floors, and other surtax are not likely to be associated with transmission of bloodborne infections to patients or health care workers. Consequently, extraordinary attempts to disinfect or sterilize these environmental surfaces are not necessary. Cleaning and removal of soil, which should be done routinely, is sufficient in most instances and many institutions also prefer to use detergent sanitizers which include some type of antimicrobial agent. Disinfectant-detergent formulations registered by the EPA can be used for cleaning environmental surfaces, but the actual physical removal of microorganisms by cleaning procedures is probably as important as any antimicrobial effect of the antimicrobial agent used.
There is a section in this report that deals with the cleaning and decontamination of spills of blood and other body fluids. One part deals with the strategy that should be used in a laboratory setting. In this context, the choice of a chemical germicide should be conservative because the microbial agent may be propagated or handled in relatively high concentrations. Consequently in laboratory settings, the choice of a liquid chemical germicide is one that has an intermediate level of germicidal activity. Since the CDC does not recommend specific brands of chemical germicides, the EPA system is used and, as a minimum, liquid chemical germicides that are tuberculocidal are recommended. The rationale for recommending this type of germicide is not based on the desire to control Mycobacterium tuberculosis but rather on the tuberculocidal nature of the chemical germicide which is a surrogate indicator of potency.
Before cleaning and decontaminating spills of blood and other body fluids in health care facilities such as hospitals, dialysis units, surgical suites, etc., the primary strategy is, as was stated above, that the cleaning protocol be considered as important as the presence of an antimicrobial agent. Thus, liquid chemical germicides, if they are used, can be of low or intermediate level. In this context, when a blood or body fluid spill occurs in a health care setting, or where there is frequently a large amount of blood and body fluid contamination (for example the surgical suite), the recommended procedure is to clean the area followed by an application of a liquid chemical germicide which is immediately wiped up, or by using a detergent-germicide for simultaneous cleaning and decontamination.
In the laboratory setting, by contrast, a spill of a known infectious agent, which may be present in large concentration, is decontaminated by applying the chemical germicide directly to the area for a specific amount of time, and then the area is cleaned. In health care settings, application of liquid chemical germicides for extended periods of time is not necessary or practical. Literally, no hospital protocol dealing with housekeeping procedures needs to be changed because of a concern of contamination of HIV or HBV. If an EPA registered non-tuberculocidal disinfectant detergent is used for housekeeping purposes in any department, including the surgical suite, it can continue to be used. If the institution, on the other hand, routinely uses an EPA registered tuberculocidal disinfectant detergent for housekeeping purposes, it also can continue to be used.
Likewise, protocols for disinfection and sterilization of medical devices, which inheritantly are conservative, do not have to be changed where there is a concern for HI or HBV contamination.
The above points illustrate the intent of our recommendations that deal with environmental contamination in health care facilities when there is a concern for transmission of bloodborne pathogens.
Martin S. Favero, Ph.D.
Chief, Hospital Environment Laboratory Branch
Hospital Infections Program
National Center for Infectious Diseases
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