Biosafety Biological Hazards

• Microorganisms
• Recombinant DNA (rDNA)
• CDC List of Select Agents and Toxins
• Genetically Engineered Organisms and Products

Biosafety Recombinant DNA

• Guidelines for Research Involving Recombinant DNA Molecules
• Five-person Institutional Biosafety Committee for review and approval
• Nature of the research defines the level of review and containment required
• Nonexempt research requires registration.

Select Agents and Toxins

• Applies to ALL use of identified agents/toxins and is applicable both to individuals and entities
• Between Feb 7,2003 and March 12, 2004, entities
• designated a responsible official (RO)
• developed
• a safety plan and laboratory compliance program
• an emergency response plan
• a security risk assessment
• a record management system
• a theft, loss, or release notification procedure

• acknowledged the criminal & civil penalties for violation

Radiation Safety

• Only licensed use of radiation sources, radioisotopes, radiolabeled compounds
• Regulated by the Nuclear Regulatory Commission
• Radiation Safety Committee reviews use and protocols
• Training required

Hazardous Materials

• Statutory Basis
• Sections 103 and 107 of the Contract Work Hours & Safety Standard Act (40 USC 327-330), supplemented by DOL regs at 28 CFR, Part 5
• FAR, Subpart 23.3
• OMB Circular A-110, Subpart D, Appendix A

• Applicability
• All awards over $2000 for construction
• All awards over $2500 for other activities

• Requires
• Notification to employees
• Preparation & submission of a material safety data sheet

Chemical Safety CSHA Lab Standard

• Affects all facilities using hazardous chemicals (even those using small quantities)
• Institutional Chemical Hygiene Plan must minimize employee exposure
• Information and training
• Medical exam for person showing symptoms of chemical exposure

Sample Questions:
1. Standards for handling radioactive materials are developed and  monitored by the

a. Nuclear Regulatory Commission.

b. Environmental Protection Agency.

c. Centers for Disease Control and Prevention

d. Occupational Safety  and Health Administration.

 

2.  Which of the following is mandated for the oversight of research involving recombinant DNA?

a. rDNA Committee

b. Biosafety Ethics Committee

c. Institutional Biosafety Committee

d. Institutional Biohazard committee

 

3. Which of the following best describes essential laboratory biosafety levels in medical research?
a. Biosafety cabinets class I, II, or III according to the agent under study
b. Basic and containment procedures designed to protect personnel and the environment
c. Special microbiological practices used to conduct procedures with high aerosol potential
d. Degrees of protection provided to personnel, environment, and community

 

4. Which of the following is essential to a Chemical Hygiene Plan?
a. Material Safety Data Sheet (MSDS) file

b. Monthly fire and safety drills

c. Public information program

d. Federal Food and Dru Administration inspection

 

Answers:
1. a; 2. c; 3. a; 4. a.