HIV and HBV research laboratories and production facilities

§1910.1030(e)

This paragraph includes additional requirements that must be met by research laboratories and production facilities engaged in the culture, production, concentration, and manipulation of HIV and HBV.

Research laboratory: A laboratory which produces or uses research laboratory scale amounts of HIV or HBV. Although research laboratories may not have the volume found in production facilities, they deal with solutions containing higher viral titers than those normally found in patients’ blood. Academic research laboratories are included in this definition. Laboratories that conduct research on blood and other body fluids unrelated to HIV or HBV, or that use unconcentrated blood or blood components as the source of HIV or HBV, are not considered research laboratories for the purpose of this paragraph.

Production facilities: Those engaged in industrial scale, large volume, or high concentration production of HIV or HBV.

Note

Employers in such facilities remain responsible for complying with the entire standard. Requirements stated elsewhere in the standard are not repeated here. These requirements are based largely on information from published guidelines of the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH). (Resource: Biosafety in Microbiological and Biomedical Laboratories.)

Inspection and citation guidelines: The compliance officer should review the covered facility’s plan, interview a sufficient number of employees, and observe work practices as necessary to determine if the requirements of this paragraph are met. Care should be taken to ensure the compliance officer understands the special practices and precautions in place at the facility so that the compliance officer is not placed at risk. Specific requirements include:

1.  Paragraph (e)(2)(i). The term “regulated waste” refers to the OSHA definition as found in paragraph (b) of this standard. The purpose of decontaminating regulated waste is to prevent the accidental exposure of other employees to the concentrated virus.

2.  Paragraphs (e)(2)(ii)(A) through (M). Paragraphs (A), (C), and (D) require employers to limit access to the laboratory and warn of the hazards associated with bloodborne pathogens. They must review the written policies and procedures to determine if they are adequate to ensure that access to the work areas and animal rooms is limited to authorized persons. Interviews with employees should be used to determine if the policies are followed.

3.  Paragraph (e)(2)(ii)(E). The “other physical containment device” must be sufficient to ensure that virus containing material will be kept away from the worker’s mucous membranes, unprotected skin, and breathing zone.

4.  Paragraphs (e)(2)(ii)(H) and (I). These paragraphs are designed to prevent the spread of contamination to other work areas. Paragraph (I) allows for an alternative to a HEPA filter as long as it is of equivalent or superior efficiency. HEPA filters may be ineffective in humid atmospheres.

The employer must also have made provisions for routine maintenance and/or replacement of all filters and traps.

If the compliance officer suspects that the engineering controls are failing to prevent the spread of the virus, the manufacturer should be contacted to establish the limits and required maintenance of the filters and traps.

5.  Paragraph (e)(2)(ii)(J). The compliance officer should determine if the use of needles and syringes is kept to a minimum and that they are properly handled as required, paying particular attention to establishing if the puncture-resistant containers are properly autoclaved or decontaminated before being discarded, reused, or incinerated.

6.  Paragraph (e)(2)(ii)(M). This paragraph ensures that any necessary additional procedures are developed to protect employees in situations unique to a research/production facility. The biosafety manual required by this paragraph must be reviewed and updated annually or more often if necessary. The facility will thus be required to review its procedures and determine if they are adequate to protect workers.

7.  Paragraph (e)(2)(iii). Specific containment equipment is required by this paragraph to minimize or eliminate exposure to the viruses.

If the compliance officer determines that biological safety cabinets (BSC) have been chosen as the means of containment, they must be certified (Class I, Class II, or Class III, as appropriate) when installed or moved, and at least annually.

The compliance officer should check that a dated tag is affixed to the BSC indicating who performed the certification. Alternatively, a certification report attesting to a minimum inward face velocity of at least 75 linear feet per minute and the integrity of the HEPA filters should be reviewed by the compliance officer. The report must be dated and signed by the trained technician performing the measurements and integrity tests.

In the alternative, appropriate combinations of PPE or physical containment devices (examples listed in the standard) will be accepted.

8.  Paragraphs (e)(3)(i) and (e)(4)(iii). The hand washing facility must be supplied with at least tepid water, soap, and hand towels. The eyewash must supply a sufficient quantity of water to completely flush the eyes. A 15-minute supply of continuous free-flowing water is acceptable. The hands must be free to hold the eyelids open to aid in the complete flushing of the eyes. Portable facilities are acceptable only if they meet these requirements.

9.  Paragraph (e)(4) covers additional requirements for production facilities only. The requirement in paragraph (e)(4)(v) minimizes the potential for accidental exposure of other employees from the transport of culture fluids, plastic ware, and other contaminated equipment.

10.  Paragraph (e)(5). The additional training requirements for employees in HIV/HBV research laboratories are specified in paragraph (g)(2)(ix). Any violations found should be cited under that paragraph of the standard.