# Presentation: 160421

## Biosafety/Biosecurity: An Update

- <date/time>

- Biosafety/Biosecurity: An Update

- January 22, 2004

## Where is the emphasis?

- <date/time>

- Biosafety
- Biosecurity

## Biosafety

- <date/time>

- Policy
- Handbook 1200.8 “Safety of Personnel Engaged in Research”
- VA Directive 7701 & Handbook 7701.1 “Occupational Safety & Health”
- OSHA’s regulations
- Plans
- Minor updates to 1200.8
- Revise biosafety form (10-0398)

## Biosecurity

- <date/time>

- An increasing concern
- Effects all research laboratories
- Special emphasis on BSL-3s & select agents or toxins
- Required revising Directive 2002.075 (Control of Hazardous Agents)

## Control of Hazardous Agents(Why The Re-draft)

- <date/time>

- Control of Hazardous Agents(Why The Re-draft)

- Approach:
- Facility’s comprehensive program
- Address concerns of IG
- Meet new standards
- HHS (CDC)
- USDA (APHIS)
- Clarify current requirements

## Concurrence Process

- Draft   Concurring Offices  Final Product
-                 			

## Control of Hazardous Agents:Requirements 

- <date/time>

- Control of Hazardous Agents:Requirements

- Security plan required
- Approving/authorizing entrance into labs
- Controlling laboratory access
- Physical security
- Registering labs for select agent or toxin use
- Inventory control
- Emergency preparedness
- Training

## Roles and Responsibilities

- <date/time>

- MCD is the Responsible Official
- ACOS/R&D
-  Research point of contact
-  Personnel, access, resources
- Annual assessments
- Role with R&D committee/SRS
- R&D/SRS committee
- Oversee requests for lab registration, personnel
- Acquisition, destruction of SA or toxins

## Responsible Official (RO)Alternate Responsible Official

- <date/time>

- Responsible Official (RO)Alternate Responsible Official

- Approved security risk assessment
- Ensure facility compliance
- Alternate RO
- Delegated authority from RO
- Day to day operations
- Knowledgeable (regulations, policy, science)
- Coordinate with non-research offices: Human Resources, Police, Safety, etc.

## Physical Security All Laboratories

- <date/time>

- Physical Security All Laboratories

- Control access 24/7
- Keycard or more sophisticated system that record access
- Doors self-closing
- Intrusion alarm
- Video surveillance at entrances suggested
- Unobstructed view of exterior entrances

## Physical SecurityBSL-3s & Labs with SA or Toxins

- <date/time>

- Physical SecurityBSL-3s & Labs with SA or Toxins

- Security requirements apply to:
- BSL-3 without Select Agents or Toxins
- BSL-3 with SA or Toxins
- Laboratories using SA or T
- Storage areas for SA or T

## BSL-3s and SA or Toxins Security Requirements

- <date/time>

- Security as required by Select Agents regulations (CDC or APHIS)
- Cardkey or more sophisticated system
- Code/keys specific to the laboratory
- Must record entrance & egress
- Access only to those who work in lab
- Authorized (approved Security Risk Assessment & MCD concurrence)
- Special approval: BSL-3 without SA or Toxins

## BSL-3s and SA or Toxins Security Requirements (cont.)

- <date/time>

- Audible alarms monitored by police
- Telephone in lab
- Video surveillance
- Lock all containers when out of site, not in use
- Meet requirements in Handbook 0730 “Security and Law Enforcement for:
- Windows
- Doors
- Overhead spaces

## Exempt Quantities of Toxins

- <date/time>

- Remain under tight security
- Prevent misuse or theft
- If not in sight or use must be locked up
- Accurate inventory
- Acquisition, transfer, destruction similar to SA & Toxins
- Possess only for specific protocol

## Training Requirements

- <date/time>

- Integrate Biosafety & Security
- Applicable regulation (VA, OSHA, CDC)
- Must occur prior to assignments
- Annual refresher
- Generic training
- Specific to laboratory & agents
- Maintain good records

## Required Policies and Procedures

- <date/time>

- Safety plan
- Security plan
- Physical
- Personnel & Access
- Cyber
- Inventory control
- Emergency planning & response
- Training

## Policies & Procedures

- <date/time>

- Written & updated as required
- Implementation must occur
- Documentation

## Other New Issues

- <date/time>

- BSL-3 Laboratories
- Annual Safety & Security visits by ORO
- IG remains interested in BSL-3 security
- Select Agents or Toxins
- Final rule may be out in November
- No major changes expected
- New SA or Toxin use:  report to CO
- Small amount $ for security?

## Why we are here!