Ensure that Members of the Workforce complete the required training identified in ESH100.2.IH.14 prior to performing the indicated work activity or fulfilling the indicated role.

Note: See Sandia corporate procedure HR100.2.1, Identify and Complete Sandia Required Training for all Members of the Workforce.

Ensure that:

• Risks associated with biological agents have been anticipated, identified, evaluated, and controlled.
• The site biological safety officer (BSO) conducts an exposure assessment.
• All control measures stipulated as a result of an exposure assessment are instituted and maintained.
• All proposed work is reviewed and approved by the Institutional Biosafety Committee (IBC) prior to the initiation of work.
• A Member of the Workforce is assigned responsibility as a principal investigator (PI), and this PI is a competent scientist capable of directing Members of the Workforce.
• Members of the Workforce are enrolled or removed from SNL medical consultation programs, following the process identified in HR100.4.7, Participate in Medical Monitoring/Surveillance.

Ensure that:

• Members of the Workforce are trained, knowledgeable, and proficient in appropriate laboratory techniques, safety procedures, and hazards associated with handling biological agents prior to being allowed to work with agents.
• The site biological safety officer (BSO) is contacted when work that involves biological agents is planned.
• All proposed work involving biological agents is submitted to the BSO for submission to the IBC and approved prior to the initiation of work.
• Requirements in this procedure for the specific type of biological agent (e.g., biological agents, biological toxins, recombinant DNA) are met.
• Members of the Workforce who, as a result of an exposure assessment, are to be referred to SNL Medical Services for consultation are:
  • Identified.
  • Their names are provided to the manager for enrollment following the process identified in HR100.4.7, Participate in Medical Monitoring/Surveillance.

Ensure that:

• All proposed work with biological agents is submitted to the site biological safety officer (BSO) using the IBC Project Registration (SNL/NM form or SNL/CA form).
• Agent-specific biosafety practices and procedures are incorporated into the IBC Project Registration (SNL/NM form or SNL/CA form).
• Work is not conducted until IBC approval is granted and any conditions set for the conduct of this work by the IBC have been met.
• A new IBC Project Registration (SNL/NM form or SNL/CA form) is submitted and approval is obtained when there are significant changes to the approved work or the agents used.

Ensure that:

• Laboratory facilities, practices and procedures meet the minimum requirements for the Biosafety Level (BSL) proposed for the work, as specified in Biosafety in Microbiological and Biomedical Laboratories, Centers for Disease Control and Prevention, U. S. Department of Health and Human Services, 5th edition.

• Ensure that:
  • The chemical safety requirements of ESH100.2.IH.4, Evaluate and Control Chemical Hazards, are implemented.
  • Contaminated and potentially contaminated items are decontaminated using methods known to be effective against the toxin (e.g., autoclave, chemical inactivation) before they are removed from the laboratory for disposal, cleaning or repair.
  • When feasible, recombinant toxins or toxin subunits are substituted when available for those derived from the wild type organism or intact toxin to abate or minimize the hazard.
  • Toxins are stored when not in use under lock and key or in other containers with controlled access (e.g., locked cabinet, refrigerator, lock box).
  • A running inventory log indicating the actual quantity (mass) of each toxin on hand at any time is maintained.
  • Inventory logs are retained and copies are provided to the site BSO when work with the toxin is completed (e.g. it has been destroyed or consumed).
  • All remaining toxin is destroyed at the completion of the project.
• Restrict unrelated and nonessential work from the area when stock solutions of toxins are in use.

Ensure that:

• Requirements specified for biological agents (in ESH100.2.IH.14 ) are followed.
• Applicable portions of NIH Guidelines for Research Involving Recombinant DNA Molecules of the National Institutes of Health are implemented.

Ensure that:

• Procedures in ESH100.2.OTH.3, Control Exposure to Bloodborne Pathogens are implemented when working with bloodborne pathogens.
• Members of the Workforce with occupational exposure (Bloodborne Pathogen) are identified and their names are given to the manager for their enrollment in the medical consultation program.

Ensure that

• A site-specific biosafety manual (technical work document) is developed and implemented following ESH100.2.GEN.3, Develop and Use Technical Work Documents, and in addition, incorporates the requirements in Biosafety in Microbiological and Biomedical Laboratories.

Follow the requirements for all work in the research laboratory involving the use of biological agents contained in:

• The site-specific biosafety manual (technical work document).
• Project-specific requirements contained in the IBC Project Registration (SNL/NM form or SNL/CA form).
• Additional TWDs (e.g., standard operating procedures), if applicable.

Ensure that:

• Security requirements that address the control of biological agents and emergency response requirements (e.g., for a spill cleanup) appropriate to the degree of hazard, are developed in conjunction with the site biological safety officer (BSO) and implemented.
• Actions required for security and emergency response are contained in the TWDs and communicated to Members of the Workforce.

• Ensure that appropriate permit applications are submitted:
  • For plant and animal pathogens, a permit application is submitted to the U.S. Department of Agriculture Animal and Plant Health Inspection Service (USDA/APHIS) and the application is specific to the agent and the declared use when required for plant or animal pathogens.
  • For human pathogens, a permit application is submitted to the Centers for Disease Control Etiologic Agent Import Permit Program to import or transport etiologic agents, hosts, or vectors of human disease.
• Ensure that copies of all approved permits are maintained and copies are provided to the site BSO.

Ensure that:

• Any conditions of use stipulated on the permit approved by the permitting agency are incorporated into the TWDs and implemented.
• Permit conditions for destruction of a biological agent at the permit expiration date are followed.

Prior to receiving on Sandia-controlled premises biological agents that have been rendered nonviable (i.e. dead or avirulent) through non-destructive means, such as irradiation, do the following:

• Obtain documentation of the method used to render the agents nonviable or avirulent.
• Obtain documentation confirming that the agents are nonviable/avirulent (e.g., culturing with negative results).
• Retain documentation obtained for the length of the project and provide a copy to the site BSO at the time of receipt.

Ensure that:

• Prior to acquisition, all biological agents to be obtained by any means (e.g., purchase, collaborator, gift) have been approved through the project-related IBC Project Registration (SNL/NM form or SNL/CA form).
• Prior to acquisition, all biological agents requiring regulatory permits have an approved permit in place.
• Procurement cards are only used to obtain biological agents and materials presented on the following Exempt Biological List and obtained from a domestic source:

Exempt Biological List:

• Antibodies.
• Proteins or recombinant proteins (excluding toxins).
• Restriction endonucleases.
• Commercial plasmids without gene inserts.
• BSL-1 continuous cell lines.
• DNA oligonucleotides.

Ensure that:

• Prior to purchase, the Procurement Card Biological Materials Exception form (Word File/Acrobat File) is completed and approved by the manager and site BSO.
• A copy of the approved Procurement Card Biological Materials Exception Form is maintained for the duration that the biological agents or material is kept.
• Purchase requisitions are used for any biological agent or material that is:
  • From an international source.
  • Is not on the Exempt Biological List.

Ensure that:

• Prior to requesting biological agents or materials, the Approval for Biological Material form (Word File/Acrobat File) is completed and submitted to the site BSO for approval. Note: In cases where there is no actual purchase (e.g., gift or obtaining from a collaborator), the Approval for Biological Material Form is still required, as is BSO approval.
• Contact is made with Import/Export Control to ensure that international regulations are followed for the acquisition of any biological agent or material from an international source.
• If purchase is required, the approved Approval for Biological Materials form (Word File/Acrobat File) and a copy of any approved regulatory permit, if required, are submitted with the purchase requisition.
• Copies of permits and approved Approval for Biological Materials forms are maintained for the duration that the biological agents or material is kept.
• Credit cards (e.g., P-Card, personal credit card, corporate credit card, PayPal™) are not used, nor is their use authorized to purchase any biological agents or materials from international sources or material not on the Exempt Biological List.

Principal Investigator

Ensure that:

• Transportation and shipping of biological agents is conducted in accordance with requirements established by the Shipping and Packaging Services Department for packaging and transporting hazardous materials.
• Any required regulatory permits are in place at the receiving location (e.g., recipient) prior to shipment.

Note: Consult the Sandia shipping organization contact with questions or concerns about onsite or offsite shipments.

Ensure that:

• An inventory of biological agents is maintained, both for materials currently in use or stored in the laboratory, in the electronic Chemical Information System (CIS) as defined in ESH100.2.ENV.27, Maintain an Accurate Chemical and Biological Material Inventory.
• The inventory is updated as biological agents are obtained or consumed; or the locations of use or storage are modified.

Ensure that:

• The biological hazard symbol (ES&H Sign Generator–Biological Hazard Symbol) is used to signify the actual or potential presence of a biological agent and to identify equipment, containers, rooms, materials, or combinations thereof, which contain, or are contaminated with, viable biological agents.
• Signs (ES&H Sign Generator–Biosafety Sign) which include the biological hazard symbol are posted at all entrances to the laboratory. Additional information required on the sign includes:
  • Agents present in the lab.
  • The biosafety level (BSL) designation of the lab.
  • The PI’s name and telephone number.
  • Additional contact names and phone numbers in the event of an emergency.
  • Any requirements for entry (e.g., PPE, immunizations).
• When toxins are in use in a lab, the lab has clearly posted at each entrance the following sign: Toxins in Use – Authorized Personnel Only (ES&H Sign Generator–Toxins in Use Sign). 
• The biological hazard symbol (ES&H Sign Generator–Biological Hazard Symbol) is affixed to potentially contaminated equipment (e.g., freezers, incubators, refrigerators) within the laboratory.

Ensure that:

• At the end of use, all biological agents (e.g., cultures, stocks, and other potentially contaminated materials) are decontaminated prior to disposal using effective means such as autoclaving. Once materials are decontaminated, they are disposed of in accordance with ESH100.2.ENV.26, Manage Other Waste at SNL/NM, or ESH100.2.ENV.20, Manage Other Waste at SNL/CA.
• All tissues from humans or animals are segregated for disposal through an approved incineration facility as directed in ESH100.2.ENV.26 or ESH100.2.ENV.20.
• Materials are autoclaved within the same building in which they were used or generated.
• Materials to be autoclaved outside the immediate laboratory are placed in a durable, leak-proof container that is closed for transport from one laboratory to another within the building.
• Compactors, grinders, or similar devices are not used to reduce the volume of materials.

Note: This procedure does not apply to Medical Services Center personnel, who follow ESH100.2.OTH.3, Control Exposure to Bloodborne Pathogens.