Biological Safety Management Program

FUNCTIONAL AREA GOAL: A fully compliant Biological Safety Management Program (BSMP) is implemented and maintained across the site.

REQUIREMENTS:

• DOE N 450.7 - The Safe Handling, Transfer, and Receipt of Biological Etiologic Agents at Department of Energy Facilities
• Title 29 CFR 1910.1030, Occupational Exposures to Bloodborne Pathogens. (http://www.osha-slc.gov/OshStd_data/1910_1030.html)
• Title 29 CFR 1910.1450, Occupational Exposure to Hazardous Chemicals in Laboratories. (http://www.osha-slc.gov/OshStd_data/1910_1450.html)
• Title 42 CFR Part 72, Interstate Shipment of Etiologic Agents and Part 73, Revised March 18, 2005 (http://www.cdc.gov/od/ohs/lrsat/42cfr72.htm)

GUIDANCE:

• DOE P450.4 - Safety Management System Policy, dated 10-15-96
• Biosafety in Microbiological and Biomedical Laboratories. CDC/NIH publication (current edition). (http://www.cdc.gov/ncidod/dvbid/Biosafety_manual_rev_1994.pdf)
• NIH Guidelines for Research Involving Recombinant DNA Molecules. NIH publication MSU/1998 (current edition). (http://www.niehs.nih.gov/odhsb/biosafe/nih/rdna-apr98.pdf)
• Guidelines for the Safe Transport of Infectious Substances and Diagnostic Specimens. World Health Organization publication WHO/EMC/97.3 (current edition). (http://www.who.int/emc-documents/biosafety/docs/whoemc973.pdf)

Performance Objective 1: Contractor Program Documentation:  The site (or facility) is governed by an up-to-date, comprehensive, documented biological safety program.

Criteria:

1. A documented biological safety program exists as recommended by DOE N 450.7.
    
2. The Site BSMP is defined in accordance with contract requirements (DEAR Clause).
    
3. The BSMP incorporates appropriate functions and principles of the Site Integrated Safety Management System.

Suggested lines of inquiry for this performance objective element

Performance Objective 2: Contractor Program Implementation

2.1 Biological hazards: Biological hazards on site (or within the facility) have been identified and evaluated in conjunction with a current and comprehensive biological hazards analysis.

Criteria:

1. Current biological hazard analyses have been performed for applicable facilities and other locations.
    
2. The information contain in the biological hazard analysis is accurate.

Suggested lines of inquiry for this performance objective element

2.2 Biological Safety Procedures: Biological safety procedures have been implemented and biological safety features, such as biosafety cabinets, have been installed, where feasible, to mitigate biological risk.

Criteria:

1. A complete spectrum of biological safety controls and procedures have been implemented as based on DOE N450.7.
    
2. All fixed biological safety features ( such as biosafety cabinets) that are required have been installed and maintained.

Suggested lines of inquiry for this performance objective element

2.3 Personnel Qualifications: Personnel are appropriately qualified and trained to perform their work safely and responsibly when confronted by biological hazards.

1. All users of biological etiologic agents must receive an applicable level of training in biological hazard recognition, appropriate safeguards and emergency response, as required by DOE N450.7.
    
2. Other users and custodians, staff security, etc that work around biological installations are encouraged to take awareness training.
    
3. The safety professionals dealing with biosafety are appropriately educated, trained and certified, where required.

Suggested lines of inquiry for this performance objective element

2.4 Performance Improvement: Data, statistics, "lessons learned" and other "feedback" from the site (or facility) biological safety program are disseminated on site and within the DOE biological safety community.

• Performance data and statistics related to the biological safety program are collected and reported in accordance with DOE Order 231.1 and 232.1.

Suggested lines of inquiry for this performance objective element

Performance Objective 3: DOE Line Management Oversight

The Federal Field/Site Office Staff has assigned personnel with competence commensurate with the responsibility to manage and oversee the BSMP across the site. A documented oversight program is implemented to verify the effectiveness of the BSMP across the site and at each nuclear facility.

Criteria:

1. Site Office is staffed with competent and experienced biological safety personnel.
    
2. Site Office is implementing procedures to define expectations and requirements.
    
3. Site Office oversight is being effectively conducted.
    
4. Site Office Oversight includes an evaluation that the contractor's implementation of the Biological Safety Management Program requirements demonstrates effective integration and application of the appropriate functions of the Site Integrated Safety Management System

Suggested lines of inquiry for this performance objective element

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