October 26, 1992

The Honorable Dennis DeConcini
United States Senate
Washington, D.C. 20510

Dear Senator DeConcini:

Thank you for your letter of August 26, on behalf of your constituent, Mr. Wilson Thomas, regarding the Occupational Safety and Health Administration's (OSHA) Final Standard for Occupational Exposure to Bloodborne Pathogens, and OSHA's enforcement priorities as they relate to the health care industry.

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), and other bloodborne pathogens. Of the diseases caused by these viruses, Hepatitis B is 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. The 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 disease, 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. 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.

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 constituent's 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.

Your constituent is correct in stating that the Omnibus Budget Reconciliation Act of 1990 included a provision which increased the maximum allowable civil penalties imposed for violations of the OSH Act. However, OSHA's budget is not dependent on the citations which the agency issues or penalties collected. All penalties owed under the OSH Act are deposited into the General Fund of the United States Treasury.

Your constituent also requested information on future enforcement priorities with regard to health care employers. OSHA does not currently have a national emphasis program which would target employers in the health care industry. Under the OSH Act, OSHA is required to respond to serious, formal complaints within a specified time period and it is within that framework that the vast majority of inspections in the health care industry take place.

In order to explain the general requirements of the standard, OSHA produced a video titled, "As It Should Be Done." It explains in clear, straightforward language most of the key provisions of the standard. In addition, OSHA published five fact sheets and six Bloodborne Pathogens compliance assistance booklets, including booklets for acute care facilities, emergency responders, dentists, and nursing homes. 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 effort is ongoing and will continue. Mr. Thomas may contact the OSHA office in his area to request a speaker or other assistance.

We understand that the cost of complying with this standard is of concern, and that most American health care professionals follow safe practices; 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.

Sincerely,



Roger A. Clark
Director
Directorate of Compliance Program

Enclosures



August 11, 1992

Honorable Dennis Deconcini
328 Senate Heart
Office Building
Washington, DC 20510

Dear Senator Deconcini:

We respectfully request your assistance with respect to the "Bloodborne Pathogens" standards recently enacted by the Occupational Safety & Health Administration under the Department of Labor.

We are a Phoenix based national research and consulting firm, specializing in providing services to the health care industry, primarily hospitals and physicians.

These new standards, which affect most of our clients, are intended to decrease the risk, to employees, of exposure in the work place to certain viruses, especially HBV (Hepatitis B) and HIV (Human Immunodeficiency.)

We understand the Budget Reconciliation Act provides for sharp increases in civil penalties for OSHA violations. Also, that OSHA budgets project large increases in fine revenues over the next five years.

The reaction of our clients to these new regulations are mixed. In past years, the general medical community has drawn little attention from OSHA regarding the General and Hazard Communications standards. Many believe this will continue under the Bloodborne Pathogens standards. Because of the number of employees at risk and the serious nature of the viruses, we are advising our clients to be prepared for stronger enforcement actions.

Our request is for an opinion, from the Department Of Labor, as to future enforcement priorities on health care employers. With this opinion, we can make more substantive recommendations to our clients.

With final compliance dates ranging from July 6th, to October 6th of this year, time is of the essence.

Your assistance is gratefully appreciate.

Respectfully yours,



Wilson Thomas
Executive Vice President