October 2, 2015

Stewart B. Davis, MD
Consulting Vice President, Regulatory and Medical Affairs
Vestagen Technical Textiles, Inc.
1301 West Colonial Drive
Orlando, Florida 32804

Dear Dr. Davis:

Thank you for your July 23, 2015, letter to the Occupational Safety and Health Administration's (OSHA) Directorate of Enforcement Programs. You requested a clarification of OSHA's Bloodborne Pathogens (BBP) standard, 29 CFR 1910.1030, as it pertains to "the definition and scope of engineering controls that isolate or remove the bloodborne pathogens hazard from the workplace." This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any question not specifically delineated within your original correspondence. For clarification, your specific questions are paraphrased below, followed by OSHA's response.

Background: You describe an improved textile technology, called active barrier apparel, that, if utilized for scrubs, lab coats, and scrub jackets, is claimed to reduce occupational exposure to blood and other potentially infectious materials (OPIM). The active barrier apparel technology is described as having a dual mechanism that will "make garments both fluid repellant and antimicrobial while remaining breathable."

Question: Does OSHA consider active apparel technology garments an example of engineering controls as defined in the BBP standard?

Response: No. The BBP standard provides a definition of engineering controls as it specifically applies to controlling the potential exposure to blood or OPIM, stating:

1. Engineering Controls means controls (e.g., sharps disposal containers, self-sheathing needles, safer medical devices, such as sharps with engineered sharps injury protections and needleless systems) that isolate or remove the bloodborne pathogens hazard from the workplace. [29 CFR 1910.1030(b)]

However, an active barrier garment, as you describe, would be considered a form of personal protective equipment (PPE). The BBP standard's definition of PPE states:

1. Personal Protective Equipment is specialized clothing or equipment worn by an employee for protection against a hazard. [29 CFR 1910.1030(b)]

As stated in paragraph 1910.1030(d)(3)(i), PPE is considered "appropriate" only if it does not permit blood or OPIM 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.

Please be advised that OSHA does not endorse or approve particular products or processes.

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