October 15, 1992

The Honorable Joseph Lieberman
United States Senate
Washington, D.C. 20510

Dear Senator Lieberman:

This is in response to your letter of September 10, on behalf of your constituent, Dr. Jonathan S. Appelbaum, regarding his concerns about the Occupational Safety and Health Administration (OSHA) regulation 29 CFR 1910.1030, "Occupational Exposure to Bloodborne Pathogens." He expressed concerns about the necessity for the standard, and the 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), 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, 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 employees 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% 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.

Your constituent expressed concern about the difficulty and expense he encountered in the preparation of an "OSHA manual" for his office. The Exposure Control Plan required by the standard need not be a lengthy or professionally produced document. While the Plan is a key provision of the standard, paragraph 29 CFR 1910.1030(c)(1)(ii) specifies only three (3) elements that it must contain. These elements are:

(1) The employer's "exposure determination" as defined in paragraph (c)(2) of the standard.

(2) An implementation schedule and discussion of specific methods of implementing requirements of the standard at the establishment, and

(3) A description of procedures the employer has established for evaluation and documentation of "exposure incidents" as defined in the standard.

It is not OSHA's intention that the Exposure Control Plan contain lengthy "standard operating procedures" (SOP's) for all tasks and procedures at every workplace, and specific consideration was given in designing the requirements to allow employers to develop their facilities' Plan "in-house."

Similarly, in expressing his concerns regarding the use of personal protective equipment, we believe Dr. Appelbaum has not been correctly informed of the requirements of the standard. The requirements of 29 CFR 1910.1030 for the provision and use of personal protective equipment are performance oriented. The standard requires the employer to evaluate the task and the potential contact with blood and other potentially infectious materials. In specific examples cited in your constituent's letter, procedures such as wart removal would be reasonably anticipated to result in potential exposure to blood or other potentially infectious materials and would, therefore, require the use of some level of personal protective equipment. Based on his determination of the type and extent of exposure anticipated, the employer is to select the "appropriate" personal protective equipment in accordance with paragraph (d)(3)(i) of the standard.

We also 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.

In order to explain the general requirements of the 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.

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 Programs


Enclosures



September 10, 1992

Hon. Dorothy L. Strunk
Acting Assistant Secretary
Occupational Safety and Health Administration
200 Constitution Avenue, NW
Room S2315
Washington, D.C. 20210

Dear Ms. Strunk:

I'm enclosing a copy of a letter which I recently received from one of my constituents, Dr. Jonathan Appelbaum, who is concerned about the impact of the OSHA bloodborne pathogen standards on his practice as an internist.

Specifically, Dr. Appelbaum states that he performs low-risk procedures but is still required to comply with all of the standards of the new law. He feels that the cost of implementing these standards, both in terms of dollars and professional time, is excessive and has directed his and his staff's attention away from patient care matters. In addition to the need to wear gowns, masks, and goggles, he is dismayed that his office was required to generate its own OSHA manual, which was extremely labor-intensive and costly.

I would greatly appreciate it if you would take Dr. Appelbaum's concern under serious consideration and provide me with an appropriate response to the points which he raised.

Thank you for your kind attention to this important matter.

Sincerely,



Joseph I. Lieberman



August 30, 1992

Honorable Joseph Lieberman
United States Senate
Washington, DC 20510

Dear Senator Lieberman,

I am writing as a concerned primary care physician about the impact of the OSHA bloodborne pathogen standards have had on my practice. As an internist, I perform low risk procedures, yet I am required to comply with all the standards of the new law. The cost of implementation of these standards, both in terms of dollars and time, has not been insignificant, and has directed the attention of my staff and myself away from matters of patient care. We have used universal precautions in my office for years, yet the need to wear gowns, masks and goggles to remove a simple wart is extreme! In addition, we were required to generate our own OSHA manual, not use a generic one, which was extremely labor-intensive and certainly not cost efficient.

I would urge the Congress to ask OSHA to convene a panel which would include practicing physicians, infectious disease experts, the Center for Disease Control, and other health workers to review and make recommendations to modify the regulations for physicians offices. The decisions of this panel should be open to public comment. I understand that HR 5677, which is pending in the Senate, asks OSHA to review the regulations to determine if they are unduly burdensome. I urge you to support this. I also urge you to support Senator Brown's efforts to solicit public comment on the regulation and to revise the standard based on these comments.

Thank you very much for your concern about this matter.

Very truly yours,



Jonathan S. Appelbaum, MD, FACP