November 20, 1992

The Honorable Jim Chapman
U.S. House of Representatives
Washington, D.C. 20515

Dear Congressman Chapman:

Thank you for your letter of September 16, regarding your concerns about the Occupational Safety and Health Administration's (OSHA) Final Standards for Occupational Exposure to Bloodborne Pathogens (29 CFR 1910.1030) and Hazardous Waste Operation and Emergency Response (HAZWOPER) (29 CFR 1910.120). You expressed concerns about the costs associated with both standards and requested postponement of the implementation of both standards. We apologize for the delay in this reply.

The Bloodborne Pathogens standard is designed to protect the Nation's workers, particularly health care workers, from exposure to the Hepatitis B Virus (HBV), the Human Immunodeficiency Virus (HIV), and other bloodborne pathogens. Of the diseases caused by these viruses, Hepatitis B is the most common, with 8,700 cases per year among workers in the health care profession. Hepatitis B infection may result in serious illness, potential long term disability and death. HIV causes AIDS, for which there currently is no cure and which eventually results in death. These viruses, as well as other organisms that cause bloodborne diseases, are found in human blood and certain other human body fluids. Therefore, employers have a particular responsibility to ensure that workers do not come into direct contact with blood or other potentially infectious materials while performing their job.

The development of this standard by OSHA took more than five years, beginning with close cooperation on the development of a proposed standard with the Centers for Disease Control, Department of Health and Human Services. The proposed standard was based on the scientifically sound infection control practice of "universal precautions" originally established by the CDC for handling of body fluids known to transmit HIV.

Following the publication of the proposed standard the public, particularly the dental and medical communities, submitted approximately 3,000 comments to the official record. In addition, OSHA held 5 public hearings, in Washington, D.C., Chicago, New York City, Miami and San Francisco, where 440 individuals and organizations testified. The comments and testimony underwent extensive review and analysis, and many of the suggested changes were adopted in the final rule.

In addition, the U.S. Congress held a series of hearings concerning the proposed Bloodborne Pathogens standard. Many individuals and groups testified at these hearings, including the American Medical Association and the American Dental Association.

Furthermore, Congress attached an "appropriations rider" to the FY 1992 OSHA funding bill which required the agency to finalize the Bloodborne Pathogens standard by December 1, 1991. During debate, members of Congress indicated that the risks to workers were significant and that the possibility of illness and death could no longer be ignored; it therefore used the appropriations rider to encourage the agency to expedite the promulgation of the standard.

During the development of the standard, compliance costs, those costs incurred to meet the requirements, were extensively analyzed. All OSHA workplace safety and health standards undergo a similar, very stringent, review. A key component of this review was a 3,500-facility survey, which included both large and small physicians' and dentists' offices, funeral homes, nursing homes, and blood banks among others. This survey showed that many offices already were complying with many provisions of the standard, including practicing "universal precautions."

For example, disposable gloves were in use by 96 percent of the direct patient care workers in dentists' offices before the standard became final. The costs for items already being used and procedures already in place were not included in the cost estimates for full compliance with the final standard. Therefore, the costs which were analyzed were the additional costs to those employers not currently providing their workers with items such as disposable gloves.

We understand your concerns about the increase in medical costs and the effect on health care availability. The standard was designed to protect the lives and health of workers from serious and deadly diseases, such as Hepatitis B and AIDS. OSHA believes that the relatively modest costs necessary to comply with the standard will neither put small, independent physicians and dentists out of business, nor reduce the availability of health care for American families.

In order to explain the general requirements of the Bloodborne Pathogens standard, OSHA published five fact sheets and six Bloodborne Pathogens compliance assistance booklets, including booklets for acute care facilities, emergency responders, dentists, and nursing homes. OSHA also produced a motivational video titled, "As It Should Be Done". The enclosed sheet lists titles and ordering information for all of these materials.

OSHA has ten regional offices around the United States, each with a Bloodborne Pathogens Coordinator to respond to inquiries about the standard. A listing of telephone numbers and addresses is enclosed. Since December 1991, the OSHA staff in the National, Regional and Area Offices have been conducting extensive outreach, training and education meetings on the Bloodborne Pathogens standard with a wide range of groups, including physicians and dentists. Over 1,000 individual meetings have been held and over 80,000 individuals have participated. This is the largest, most extensive, training and education effort in the 20 year history of OSHA. This effort is ongoing and will continue.

OSHA published its regulations on Hazardous Waste Operation and Emergency Response (HAZWOPER) on March 6, 1989 (54 CFR 9294). The regulations became effective on March 6, 1990 and replaced an interim final rule that was required by Congress in the Superfund Amendments and Reauthorization Act of 1986 (SARA). The rule regulates the safety and health of the employees involved in clean-up operations at uncontrolled hazardous waste sites, employees engaged in certain hazardous waste sites, employees engaged in certain hazardous waste treatment, storage, and disposal (TSD) operations, and in any emergency response activities involving hazardous substances. State and municipal employees (e.g., EMS/Fire Service employees) are covered by the standard in those states which operate their own Federally-approved state OSHA program. In those states under Federal OSHA, the Environmental Protection Agency (EPA) regulates State and local employees, including volunteers, under 40 CFR 311.

The standard protects the safety and health of employees involved in clean-up operations at hazardous waste sites, operations at hazardous waste treatment, storage and disposal facilities, and emergency responses to releases or potential releases of hazardous substances. Community response organizations such as fire-fighters, emergency medical services and hospitals must comply with 29 CFR 1910.120 when they respond to a release of hazardous substance.

SARA Title III required each state to develop a State Emergency Response Commission (SERC). SERCs, in turn, were expected to establish planning districts with Local Emergency Planning Committees (LEPCs). Each LEPC was to have assessed the hazards present within the local area and developed a comprehensive emergency response plan. Clearly, the intent and expectation of Congress as expressed in SARA Title III was that community response services were to plan for and participate in responses to hazardous substance emergencies.

Like the Bloodborne Pathogens standard, HAZWOPER is a performance-based regulation, allowing individual employers flexibility in meeting the requirements of the regulation in the most cost-effective manner. It is not OSHA's intent that every member of a community's emergency response services receive high levels of specialized hazardous materials training. The community may determine that it is appropriate for the fire department to develop a small group of highly trained hazardous materials technicians and specialists, called a "Hazmat team," or may find that the community does not require a hazmat team and that less intensive training is adequate. Likewise, all emergency medical technicians (EMTs)(e.g., ambulance corps members) do not need to be trained to treat contaminated victims.

To determine the appropriate level and type of training under HAZWOPER, community response agencies will need to consider the hazards present in their community, and determine what capabilities will be required to respond effectively to those hazards. This determination is to be based on worst-case scenarios. A community where a tank farm storing immense quantities of hazardous substances is located will have different needs than a locality where there is a meat processing facility with a refrigeration system using ammonia as a cooling agent. Many communities may find that emergency planning efforts conducted to meet the requirements of SARA Title III will fulfill several of the requirements of HAZWOPER.

Each individual must be adequately trained to perform their anticipated job duties without danger to themselves or others. For example, firefighters would typically require eight hours of training. In many cases, firefighters would be able to "objectively demonstrate competency" in the required training areas without additional training; previous experience and training under NFPA guidelines would probably be adequate.

Emergency medical technicians expected to treat contaminated victims would also require eight hours of training, but the specific tasks in which they would require training would be somewhat different than those for firefighters. The individual who would set up a hazardous substance decontamination unit for a hospital would need eight hours of training plus special training in decontamination procedures, but would not require all of the lengthy specialized training required for a hazardous materials technician.

Hospitals which have been designated to accept and treat contaminated victims must be prepared to carry out these functions while safeguarding the health and safety of hospital employees. In planning for emergencies, LEPCs, hazardous waste sites, and facilities which have the potential for a hazardous substance emergency are required to designate a local hospital which has agreed to accept and treat contaminated accident victims. A hospital would also fall under the scope of the regulation when an internal release of a hazardous substance such as ethylene oxide (a potent disinfectant commonly used in hospitals) requires an emergency response, or if the hospital is a RCRA-permitted Treatment, Storage and Disposal Facility (e.g., a medical waste incinerator).

There are several options to meet the training requirements of 1910.120. An in-house training program may be developed. Paragraph (q)(7) defines credential requirements for trainers. Training courses are also available from a number of sources, at varying costs. You may wish to contact the National Institute for Environmental Health Sciences (NIEHS) for information on training courses developed by universities and other not-for-profit organizations, at the following address:

Worker Training and Education Branch Occupational Health & Technical Services NIEHS, North Campus Building, 18 Room 1810 Research Triangle Park, North Carolina 27709

In some cases facilities with the potential for a hazardous substance emergency may be able to provide community response agencies with technical assistance in developing the community's emergency response capabilities for the specific hazards of their facilities. State Emergency Response Commissions would have extensive technical resources to aid the community. The OSHA Regional Offices would be able to provide assistance in understanding the requirements of the regulation. As you may be aware, half of all states operate their own OSHA-approved state safety and health plans, which provide coverage which is "at least as effective" as that required by OSHA. Please find enclosed the addresses for the above mentioned resources.

Please be aware that the Bloodborne Pathogens standard and the HAZWOPER standard are already in effect. Like all OSHA regulations, both standards in question were promulgated after extensive public review and comment on their respective proposed provisions. The information gathered during the public comment period was then used as a basis in development of the final standards. With more specific regard to your concerns, the compliance deadlines published in the proposed Bloodborne Pathogens standard were more stringent. However, various commenters expressed concern that they may not be able to meet the proposed deadlines. Based on the information received from the interested parties, the compliance deadlines were revised to those which the information led the Agency to conclude could be realistically achieved. In addition, OSHA found that it was economically feasible to implement both standards in their respective affected industries or groups.

Your concerns about the challenges rural communities may face in implementing the OSHA bloodborne pathogens and HAZWOPER standards are also shared by OSHA. The Agency has attempted to provide numerous outreach efforts to assist rural communities in complying with the standards, by proving training and information materials as well as presentations. In addition, OSHA-funded state consultation programs provide assistance to employers in complying with OSHA standards. (Please see enclosed material.) Regarding the issue of coverage of volunteers, the Agency's present position is that volunteers are not employees and are thus not covered under the requirement of the standard. This issue is under review at the present time due to recent court decisions. Should any change in the Agency's current policy result as a consequence of this review we will inform you.

After reviewing your request for delay of the effective dates of the standards and on the basis of all the information presently available to OSHA, we have decided that for the reasons stated above your request cannot be granted.

We hope that the information we have provided is of assistance to you. Should you have additional questions, please feel free to contact us.

Sincerely,



Roger A. Clark,
Director
Directorate of Compliance Programs