Chapter 34 Table of Contents. View the entire chapter in a PDF format. Please use the pdf for printing.

Requirements:
General (5.1)

SLAC requirements conform to Stanford University's policy on handling biohazardous material. SSRL safety requirements for Biohazards will be used for all of SLAC.

Note: The Stanford University Biosafety Manual [pdf] represents the institutional practices and procedures for the safe use and handling of biological materials and recombinant DNA, and is a primary reference for work conducted at SLAC.

Approval and Review

Risk Assessment

All experiments involving biohazardous materials must be categorized according to the risk they pose. The relevant risk assessment resource depends on the type of biohazardous material under consideration.

• Recombinant DNA (rDNA). Risks involving rDNA must be categorized according to NIH guidelines.
  "Guidelines for Research Involving Recombinant DNA Molecules"
• Infectious agents. Risks must be categorized according to the CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL). Both the category (risk group) of the agent and the manner in which it will be used determine the biosafety level.
• Select Agents. No select agents are permitted at SLAC.

Biosafety Level

The biosafety level assignment is a function of the potential hazards of the material and how it will be used and determines the extent of required controls and review:

• Level 1 - no restrictions
• Level 2 - requires review by the Stanford University APB (see below)
• Levels 3 and 4 - not allowed at SLAC

Approval

SSRL

SSRL requires that researchers working with biohazardous material

• Submit a completed SSRL Proposal Form
• Submit a Hazards Form four weeks prior to the experiment date
• Comply with any requests for information and submit in written format those response procedures to be followed in the event of accidental spills of biohazardous material. The procedures should include sufficient detail and clarity so they can be carried out by laboratory-competent personnel.

All work or research with biohazardous materials must be performed by authorized personnel only.

Other SLAC Entities

SSRL safety requirements for Biohazards will be used for all of SLAC.

APB Review

All biohazardous material with a determination of biosafety level 2 must be reviewed by the Stanford University APB. Researchers must submit the completed APB form to the SSRL safety coordinator who will present the information to the APB, and communicate any special controls or requirements to the researcher.

(Reference:  Stanford University Administrative Panel on Biosafety Request for Institutional Review/Approval for Research Involving Biohazardous Agents, Recombinant DNA, and USDA-regulated Materials [doc])

Transport

All applicable federal and state regulations, including the International Air Transport Association (IATA), Department of Homeland Security (DHS), and Department of Transportation (DOT) regulations pertaining to the transport of biohazardous materials apply.

If regulations require that biohazardous material be sent via a carrier, it must be received by a shipper/handler with the proper training to handle that class of biohazardous material.

Work Practices

• Work practice requirements are determined by the biosafety level and the requirements associated with them as specified in the Stanford University Biosafety Manual [pdf].
• Researchers must implement the appropriate work practices and equipment and facility requirements.
• Researchers must adhere to the approved protocol and notify the safety officer/safety coordinator before making any changes.

Storage/Disposal

• Biohazardous material may only be on-site for the duration of the experiment, and must be removed within one business day of experiment completion. If such material must temporarily be stored for one business day, requirements include limiting the biohazardous material to the minimum required amount, properly labeling all such material, and keeping it properly contained, as described in the Stanford University Biosafety Manual [pdf].
• At the conclusion of the experiment, researchers must properly pack any remaining biohazardous materials under the supervision of a trained SLAC handler/shipper. The researcher is responsible for arranging a carrier (if applicable under regulations) and ensuring that all biohazardous material is removed within one business day.

Reporting

The Biohazards program manager must maintain an inventory and status of biohazardous agents, and provide an annual status report to the Department of Energy (DOE) Site Office describing the status and inventory of these agents and the Biohazards program.

Accidents and Accident Reporting

Everyone working with biohazardous material must follow procedures involving blood-borne pathogens in Chapter 46, "Blood-borne Pathogens".

All accidents and near misses must be reported to the safety coordinator for the affected area and the program manager in accordance with Chapter 28, "Incident Investigation".

Equipment

• Equipment used in the storage, preparation, and examination must be purchased and used in the manner the manufacturer intended. Procedures described by the manufacturer for decontamination and sterilization must be followed.
• Biosafety cabinet purchases must be approved by a qualified safety coordinator.
• Facilities must be designed and maintained for the appropriate biosafety level.
• Ventilation must be constructed and operated per applicable regulations.
  (Reference:  Centers for Disease Control and Prevention and National Institutes of Health (CDC-NIH), Primary Containment of Biohazards: Selection, Installation and Use of Biological Safety Cabinets, second edition, 2000)
• Biosafety cabinets must be periodically inspected by a qualified inspector.

Personnel and Users

• All personnel and users must be trained as specified in the training section before working with biohazardous material.
• All personnel must wear personal protective equipment (PPE) appropriate to the biosafety level of the materials with which they are working

continue to Requirements, Roles & Responsibilities (5.1.9)