January 16, 2015

Richard L. Raimondo, Jr., D.D.S.
12521 Nacogdoches #103
San Antonio, Texas 78217

Dear Dr. Raimondo:

Thank you for your August 10, 2014, letter to the Occupational Safety and Health Administration (OSHA). Your letter has been referred to the Directorate of Enforcement Programs for a response. You requested a clarification of OSHA's Bloodborne Pathogens (BBP) standard, 29 CFR 1910.1030. 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. For clarification, your specific questions are paraphrased below, followed by OSHA's responses.

Question 1: Once my employees have completed the 3-dose hepatitis B vaccination series, is there a requirement to obtain a test for hepatitis B antibodies?

Response: Yes. According to OSHA's BBP standard, the hepatitis vaccination series is to be provided according to the most current recommendations of the U.S. Public Health Service at the time the vaccinations take place. [29 CFR 1910.1030(f)(1)(ii)(D)] At the time of this writing, the most current guidance is provided in the Centers for Disease Control and Prevention's, CDC Guidance for Evaluating Health-Care Personnel for Hepatitis B Virus Protection and for Administering Postexposure Management, MMWR 2013:62 (No. RR-8), which states: "Postvaccination serologic testing for anti-HBs is recommended 1-2 months after the last vaccine dose for HCP [health-care personnel] at risk for occupational percutaneous or mucosal exposures." Such HCP include dental personnel. Id. at 2.

Question 2: After an exposure incident, am I required to pay for the testing of the source patient?

Response: Yes. The OSHA BBP standard states that the employer shall ensure that all medical evaluations and procedures are made available at no cost to the employee, "...including the hepatitis B vaccine and vaccination series and post-exposure evaluation and follow-up, including prophylaxis..." [29 CFR 1910.1030(f)(1)(ii)] The BBP standard specifically identifies testing of the source patient's blood as a component of the post-exposure evaluation. [29 CFR 1910.1030(f)(3)(ii)(A)]

Question 3: Are personal protective equipment (PPE) and gauze that are not saturated with blood or other potentially infectious material (OPIM), such as saliva in dental procedures, required to be disposed of as regulated waste?

Response: No. The BBP standard defines regulated waste as "liquid or semi-liquid blood or other potentially infectious materials; contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed; items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling; contaminated sharps; and pathological and microbiological wastes containing blood or other potentially infectious materials." [29 CFR 1910.1030(b)] As long as the PPE and gauze do not meet the criteria described in the definition of regulated waste, there is no requirement to dispose of that PPE and gauze as regulated waste. It is important to note that the definition of OPIM includes "saliva in dental procedures." [29 CFR 1910.1030(b)] As stated in OSHA's letter of interpretation to Dr. Richard W. D'Eustachio (2/15/1996), "[o]ccupationally acquired infection with HBV in dental workers has been documented," and "[d]uring dental procedures, contamination of saliva with blood is predictable." Additionally, disposal of regulated waste shall comply with applicable regulations of the United States, States and Territories, and political subdivisions of States and Territories. [29 CFR 1910.1030(d)(4)(iii)(C)]

Question 4: What PPE is required in a dental office in addition to mouth/nose mask, safety glasses, and gloves?

Response: The BBP standard is performance based and, as such, the employer has the latitude to determine which PPE best suits the workplace environment and the anticipated occupational exposure. The employer's decision of "[t]he type and characteristics" of the PPE shall "depend upon the task and degree of [occupational] exposure anticipated." [1910.1030(d)(3)(xi)] The BBP standard provides that when there is occupational exposure, the employer shall provide, at no cost to the employee, appropriate personal protective equipment such as, but not limited to, gloves, gowns, laboratory coats, face shields or masks and eye protection, and mouthpieces, resuscitation bags, pocket masks, or other ventilation devices. [1910.1030(d)(3)(i)] This provision of the standard also states: "Personal protective equipment will be considered 'appropriate' only if it does not permit blood or other potentially infectious materials to pass through to or reach the employee's work clothes, street clothes, undergarments, skin, eyes, mouth, or other mucous membranes under normal conditions of use and for the duration of time which the protective equipment will be used." In the dental setting, in addition to the PPE noted in the question, it is customary to also use protective clothing, such as clinic jackets, lab coats, or uniforms.

Question 5: As the unincorporated sole-proprietor of a dental office, am I bound by the same requirements for PPE as my employees?

Response: No. The Occupational Safety and Health (OSH) Act of 1970 only applies to "employment." [29 U.S.C. § 653(a)] Thus, healthcare professionals who are sole practitioners or partners are not considered employees under the OSH Act; therefore, they are not covered by the protections of the standard. [Most Frequently Asked Questions Concerning the Bloodborne Pathogens Standard, OSHA, Feb. 1, 1993] However, sole-proprietor dentists are still required to implement all components of the BBP standard for their employees, who are covered by the OSH Act.

OSHA recommends that each sole-proprietor healthcare provider protect himself or herself in accordance with the BBP standard, because there is greater employee compliance and protection when the employer sets the example in the protection against human pathogens in healthcare settings. For additional information, we are enclosing copies of two OSHA guidance publications: Medical and Dental Offices - A Guide to Compliance with OSHA Standards*; and, OSHA Fact Sheet -- Updates to OSHA's Reporting and Recordkeeping Rule.

Additionally, OSHA has an on-site consultation program that is administered at the state level. It is a service funded by OSHA and is free to the user. Additional information on this service may be found at www.osha.gov/dcsp/smallbusiness/consult.html. Our website, accessible at www.osha.gov, contains additional information on training programs and compliance assistance for private-sector industries.

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 letter of interpretation explains 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,

Thomas Galassi, Director
Directorate of Enforcement Programs

Enclosures