February 5, 1993

(Name Withheld)

Dear (Name Withheld):

Thank you for your letter of November 16, regarding your concerns about the Occupational Safety and Health Administration's (OSHA) Final Standard for Occupational Exposure to Bloodborne Pathogens. You expressed concerns about the necessity for the standard, and standard's requirements and costs.

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 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 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.

With regard to your concern about specific personal protection equipment (PPE) requirements of the standard, you should be aware that these requirements are performance-oriented and allow for the exercise of professional judgement. The standard requires that PPE be "appropriate". OSHA considers PPE to be appropriate if it does not permit blood or other potentially infectious material to pass through to the employees' underlying garments, skin, eyes, mouth, or other mucous membranes under normal conditions of use and for the duration of time that the PPE will be used. This allows the employer to select PPE based on the type of exposure and the quantity of blood or other potentially infectious material which can be reasonably anticipated to be encountered during performance of a task or procedure.

We understand your concerns about the increase in medical costs and the effective 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 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. Please contact the OSHA office in your 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 to 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



November 16, 1992

The President
The White House
Washington, DC 20510

Dear Mr. President:

I am writing this letter to make some comment about the current OSHA standards for physicians and health care workers that we are now implementing in our offices. I am complying with these regulations because these are the regulations, but I submit to you gentlemen that these regulations can be improved rather dramatically. It seem to me there is one sweeping set of regulations that regulates everyone the same way and no thought is given in these regulation regarding the varying risk factors that occur in different health care settings.

For example: when I am doing procedures which require very fine touch, by these recommendations I will have to wear protective clothing, protective eye covering and gloves. In many of the procedures that I do there is minimal chance for blood contamination or blood being sprayed about the area where the operation is being done and the use of eye covers impedes vision, the use of gloves impedes tactile sensation and really diminished the ability to perform the procedure compared to if these items were not used.

In summary, then I think that the individuals who have the power should give some consideration to the recommendations that have been made by a group such as the American Association of Clinical Endocrinologists that a six-month grace period be given for enforcement and a moratorium of a similar nature be given on fines related to these new OSHA standards and also I think the people in power need to support the notion that there should be a solicitation of public comment on the regulations before they are permanently implemented and I think the regulations need to be changed to reflect more accurately varying risk factors depending on the different health care settings that are involved. If any of you gentlemen have any questions, I will be glad to speak with you individually. I just think these OSHA rules are somewhat arbitrary and there should be some leeway for making different levels of regulation for different areas in the health care setting. To make every health care setting conform to the most stringent requirements seems to me to be burdensome, expensive, and probably counter productive.

Very truly yours,



Samuel P. Marynick, M.D., P.A.