August 18, 1992

Laird F. Schaller, M.D.
5501 Marquette Dr.
Plano, TX 75093-2819

Dear Dr. Schaller:

This is in response to your letter of May 27 regarding the Occupational Safety and Health Administration (OSHA) regulation 29 CFR 1910.1030, "Occupational Exposure to Bloodborne Pathogens." Specifically, you requested that OSHA redefine "'who is covered' to apply to those individuals who are at a significant risk instead of anyone who might possibly be exposed..." Please accept our apology for the delay in this response.

The Bloodborne Pathogens standard is designed to protect the Nation's workers, particularly health care workers, from exposure to the Hepatitis B Virus (HBV) and the Human Immunodeficiency Virus (HIV). Of these two diseases, Hepatitis B is more 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. The HIV virus 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 medical community, 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 hearing, including the American Medical 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. Congress believed 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.

Your request to redefine "who is covered" seems to stem from your understanding that all employees trained in first aid are to be covered by this standard. The key to this issue, however, is not whether employees have been trained in first aid, but whether they are also designated as responsible for rendering medical assistance. The standard does not necessarily apply to employees who are trained in first aid (especially when the company only requires that employees perform forms of emergency assistance that do not involve exposure to body fluids) but only to those employees who are required by the employer to actually administer first aid.

However, OSHA has recently issued a policy statement specifying that, while designated first aiders are covered under the scope of the standard, failure to offer the hepatitis B vaccine pre-exposure to persons who render first aid only as a collateral duty will be considered a technical violation carrying no penalties, provided that a number of conditions are met (see enclosed news release. Please note that all other requirements of the standard continue to apply to first aid providers.

We would also like to address your concerns with compliance costs. 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% 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 companies and independent physicians out of business, nor reduce the availability of health care for American families.

We understand that the cost of complying with this standard is of concern. However, the risks of illness and death from HBV and HIV for workers are too great to ignore, and they mandate the full employee protection and training required by the standard. We hope this adequately addresses your concerns.

Sincerely,



Patricia K. Clark, Director
Directorate of Compliance Programs