August 4, 1999

Mitchell S. Y. Cohen, Esq.
Kaiser Foundation Health Plan, Inc.
One Kaiser Plaza, 21st Floor
Oakland, California 94612

Dear Mr. Cohen:

Thank you for your fax, dated July 1, 1999, resubmitting the original letter written to us by your assistant, Ms. Hee Lee Young, and dated August 7, 1998. I apologize for the extreme delay in responding to you. As Ilma Rosskopf explained in her telephone call to you on July 1, we have been following up to see that all correspondence during the past year has been responded to and found that this one was outstanding because the original letter had been lost somewhere in the chain of signatory offices within the agency. As requested, I am expediting the response to you.

You request clarification on what constitutes medical treatment under 29 CFR 1904.12(d). Specifically, you state that there "is some confusion as to whether the administration of a hepatitis B vaccine booster, after a bloodborne pathogen exposure incident, is considered medical treatment and therefore recordable on the OSHA Log 200." The answer is that it is recordable. You also asked for an explanation as to why it is recordable. The short answer is that the bloodborne exposure incident is evaluated as an injury for OSHA recordkeeping purposes. The administration of the hepatitis B vaccine booster, in response to the injury, is considered to be medical treatment, as it is intended to boost the immune system to protect it from the onset of the disease from that bloodborne exposure incident in addition to future bloodborne exposure incidents.

To further explain this answer and respond to the several separate points in your letter, I will restate the issues raised in your letter and respond to each separately.

1. On page 43 of the Recordkeeping Guidelines, it states that the administration of tetanus shots or boosters is not considered medical treatment. The guidelines do not specify, nor limit, the type of boosters that are exempt from the recordkeeping requirements.

The statement on Page 43 of the Recordkeeping Guidelines, "Administration of tetanus shot(s) or booster(s)," refers only to tetanus shots and tetanus boosters. The term "booster" should not be taken out of context of the paragraph and applied to all vaccines. As a general rule, whether treatment given in response to an occupational injury is preventative or precautionary in nature is not a determining factor for recordability. The sole exception to this rule is the tetanus shot and tetanus booster (See enclosed Letter of Interpretation to Union Carbide, dated March 16, 1995).

2. Additionally, the Q&A B-9 on Page 30, states that if an employee is inoculated to prevent the spread of an illness, but is not injured or ill, then the inoculation is not recordable. From this language, one can infer that if a booster shot is administered to protect against future exposure events and there is no actual injury, then the booster is exempt from the recordkeeping requirement.

For a case to be recorded on the OSHA Log 200, an employee must have an injury or illness. In the scenario described in Q&A B-9 on Page 30 of the Recordkeeping Guidelines, the employees have neither. However, in the scenario described in your letter, the employee has experienced a bloodborne pathogen exposure incident (e.g. a needlestick or laceration with contact to potentially infectious material), which is defined as an occupational injury for OSHA injury and illness recordkeeping purposes.

3. According to an OSHA directive (CPL 2-2.44C; under subheading, "Acute Exposure to Blood That Contains (or might contain) HbsAg" and "Hepatitis B Vaccine"), a person who has been vaccinated against hepatitis B, will most likely be protected from an exposure, even if the person's antibody level wanes. Between 30% - 50% of persons who develop adequate antibody levels after vaccination will lose detectable antibodies within seven years. However, the protection against viremic infection and clinical disease still persists. The directive states that it may be prudent to administer a booster if the anti-body level is inadequate. It is our understanding that the hepatitis B vaccine booster is administered to protect against future exposure incidents. It is not administered to protect against the current exposure incident. Therefore, like the tetanus shot, it is just a precautionary measure and is not indicative of actual injury.

According to OSHA Directive CPL 2-2.44C - Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens Standard, 29 CFR 1910.1030, Section J (Recording of Exposure Incidents) Paragraph #2, medical treatment beyond first aid is recommended, mentioning the Hepatitis B Vaccine by name (along with other specific medical treatment beyond first aid recommendations). Thus, Hepatitis B Vaccine is defined as medical treatment and its administration would make a case recordable on the OSHA 200 Log. See also Pages 46 through 58.

We disagree with your understanding that the Hepatitis B vaccine "is not administered to protect against the current exposure incident." According to the CDC's MMWR No. S-6, dated June 23, 1989 (Guidelines for Prevention of the Transmission of Human Immunodeficiency Virus and Hepatitis B Virus to Health-Care and Public-Safety Workers), "Hepatitis B vaccines...are 70-80% effective when given within one week after Hepatitis B virus exposure." In addition, the CDC states, "Combination treatment with Hepatitis B vaccine and HBIG" (Hepatitis Immunoglobulin) "is over 90% effective in preventing Hepatitis B following a documented exposure." Therefore, OSHA considers the Hepatitis B vaccine to be medical treatment for the exposure incident, and not merely a precautionary treatment for future exposure incidents.

4. An August 22, 1995 letter of interpretation from your office states that a booster shot of hepatitis B vaccine is recordable as medical treatment, but does not explain why. It simply lists the hepatitis B vaccine along with gamma globulin, hepatitis B immune globulin, and zidovudine, seemingly ignoring the differences between a booster of hepatitis B vaccine and other vaccines. The latter are used to prevent infection from the current exposure incident while the hepatitis B vaccine is not. Rather it is a precautionary measure, administered to protect against any future exposure incidents. The letter also states that 'The OSHA injury and illness recordkeeping system is not designed to record exposure incidents.' Requiring recordkeeping of the hepatitis B vaccine booster contradicts this, because this booster is not indicative of actual injury. This booster is a precautionary measure used to protect against future exposure incidents. Therefore, requiring recordkeeping of this booster would, in essence, be requiring the recording of exposure incidents.

As stated in Question 3, we disagree with your understanding that the hepatitis B vaccine booster "is not administered to protect against the current exposure incident." The goal of the booster at the time of exposure is treatment for that episode because the immune response should precede the onset of disease. As stated in Question 2, bloodborne pathogen exposure incidents, such as needlesticks and lacerations with contact to potentially infectious material, are occupational injuries. Therefore, OSHA considers the hepatitis B booster medical treatment for the exposure incident, and not merely a precautionary treatment for future exposure incidents.

I hope you find this information useful. If you have any further questions or comments, please contact the Division of Recordkeeping Requirements, at Area Code: (202) 693-1702.

Sincerely,

Cheryle A. Greenaugh
Director, Directorate of Information Technology

Enclosure: Letter of Interpretation to Union Carbide dated 03/16/95