February 7, 2007

Mr. Douglas Kitt
EHS Coordinator
Myriad Genetics, Inc.
320 Wakara Way
Salt Lake City, UT 84108

Dear Mr. Kitt:

Thank you for your letter to the Occupational Safety and Health Administration. Your letter was forwarded to OSHA's Directorate of Enforcement Programs (DEP) for response. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any question not delineated within your original correspondence. You had specific questions regarding acceptable documentation of employees' hepatitis B vaccination status.

Scenario: It is very common for employees new to our company to have already received the HBV vaccination series while working with a previous employer. Some employees who have been previously vaccinated do not have copies of the vaccination records indicating the exact dates of vaccination.

Question 1: What type of record is sufficient to document an employee's hepatitis B immunization status under the bloodborne pathogens standard?

Reply 1: As you may know, employers are required to maintain an accurate copy of each employee's hepatitis B vaccination status, including the dates of all the hepatitis B vaccinations [29 CFR 1910.1030(h)(1)(ii)(B)]. The documentation of vaccination status serves as a useful tool in assisting healthcare professionals who must administer post-exposure counseling and treatment to employees following an exposure incident. Documentation showing administration of the complete 3-dose series is necessary to prevent unnecessary repeated vaccination. The Centers for Disease Control and Prevention (CDC) considers a reliable vaccination history to be a written, dated record of each dose of a complete series. ¹ Employers must make every effort to obtain a reliable record of employees' vaccination status. These efforts may include contacting the previous employer or facility where the vaccination was administered to obtain these records. As it is a requirement that all employers maintain these records for the duration of employment plus 30 years, a previous employer who administered hepatitis B vaccinations would have copies of those records [29 CFR 1910.1030(h)(1)(iv)]. If a copy of the vaccination record cannot be obtained, then OSHA recommends that documentation verifying the employer's attempt to obtain the record be maintained. When these records cannot be obtained from the previous employer, the current employer must obtain from the employee a written statement about vaccination status, including the dates or, where this is not possible, the approximate dates of the vaccinations.²

Question 2: If an employer is unable to obtain copies of the actual records verifying an employee's HBV vaccination, is it required that employers provide a blood test to document hepatitis B immune status?

Reply 2: No, it is not required that an employer administer serologic testing in order to document previous hepatitis B vaccination from another place of employment for employees who claim to have received the vaccination prior to beginning a new job. In fact, the standard prohibits making participation in a prescreening program a prerequisite for receiving hepatitis B vaccination [29 CFR 1910.1030(f)(2)(ii)]. When the employer cannot obtain records or employees are uncertain about whether they were vaccinated, the hepatitis B vaccine must be made available, unless previous antibody testing has revealed that the employee is immune or the vaccine is contraindicated for medical reasons [29 CFR 1910.1030(f)(2)(i)]. Vaccination of persons who have previously been vaccinated does not increase the risk for adverse events.³

For your information, Utah is one of the 26 States that operate an OSHA-approved State plan. Utah's occupational safety and health program is administered by the Utah Labor Commission's Occupational Safety and Health Division (UOSH). State plans are responsible for adopting and enforcing occupational safety and health standards that are at least as effective as those promulgated by Federal OSHA. UOSH has adopted a standard that is identical to the Federal OSHA bloodborne pathogens standard (29 CFR 1910.1030). For additional information about UOSH, including its application of the bloodborne pathogens standard, we suggest that you contact the agency at:

Louis Silva, Administrator
Utah Occupational Safety and Health Division
Utah Labor Commission
160 East 300 South, 3^rd Floor
P.O. Box 146650
Salt Lake City, Utah 84114-6650
Tel. (801) 530-6898
Fax (801) 530-6390

Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA requirements are set by statute, standards, and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at http://www.osha.gov. If you have any further questions, please feel free to contact the Office of Health Enforcement at (202) 693-2190.

Sincerely,



Richard E. Fairfax, Director
Directorate of Enforcement Programs

¹ MMWR, A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States, December 8, 2006/Vol. 55/No. RR-16, (hereinafter, "MMWR") p. 26. [ back to text ]

²MMWR, p. 27. [ back to text ]

³ MMWR, p. 27. [ back to text ]