Biological Risk Assessment Form

Biological Risk Assessment Form Template for United States

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Key Requirements PROMPT example:

"Need a Biological Risk Assessment Form for our new BSL-2 research project involving CRISPR gene editing of E. coli strains, to be submitted to the university's biosafety committee by March 2025."

Document background

The Biological Risk Assessment Form is a critical document required by U.S. federal regulations for any work involving biological materials. It assists organizations in meeting OSHA, NIH, and CDC compliance requirements while protecting worker safety and public health. The form must be completed before initiating any work with biological materials and updated when significant changes occur in procedures or materials. It includes detailed analysis of hazards, control measures, and emergency procedures, serving as both a practical guide and legal documentation.

Suggested Sections

1. Project Information: Basic details about the project, facility, and responsible personnel

2. Agent Classification: Identification and risk group classification of biological agents

3. Laboratory Safety Level: Assessment of required containment level

4. Risk Identification: Detailed analysis of potential hazards

5. Control Measures: Specific safety procedures and containment measures

6. Emergency Procedures: Response protocols for accidents or exposures

Optional Sections

1. Gene Modification Assessment: Required when working with genetically modified organisms

2. Animal Use Assessment: Additional considerations for work with animals

3. Clinical Sample Handling: Specific procedures for human specimens

Suggested Schedules

1. PPE Requirements: Detailed list of required personal protective equipment

2. SOPs: Standard Operating Procedures for specific procedures

3. Training Records: Documentation of required training completion

4. Risk Matrix: Standardized risk assessment scoring system

5. Decontamination Procedures: Specific protocols for cleanup and decontamination

Authors

Alex Denne

Head of Growth (Open Source Law) @ ��Ƶ | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

alex.den.21@genieai.co

Relevant legal definitions

Clauses

Relevant Industries

Academic Research
Pharmaceutical
Biotechnology
Healthcare
Government Research

Relevant Teams

Research & Development
Environmental Health & Safety
Quality Assurance
Operations
Regulatory Affairs

Relevant Roles

Research Scientist
Laboratory Technician
Safety Manager
Quality Assurance Manager
Facilities Manager

Industries

OSHA Bloodborne Pathogens Standard: 29 CFR 1910.1030 - Federal regulation that prescribes safeguards to protect workers against health hazards from exposure to blood and other potentially infectious materials

NIH Guidelines: Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules - Specifies practices for constructing and handling recombinant DNA molecules and organisms containing them

BMBL Guidelines: CDC/NIH Biosafety in Microbiological and Biomedical Laboratories - Provides comprehensive guidance on biosafety and containment practices for laboratories

Select Agent Regulations: 42 CFR Part 73, 7 CFR Part 331, and 9 CFR Part 121 - Regulations governing the possession, use, and transfer of biological select agents and toxins

EPA Regulations: Environmental Protection Agency regulations governing environmental impact and safety measures for biological materials

RCRA: Resource Conservation and Recovery Act - Federal law governing proper disposal of biological waste materials

DOT Hazardous Materials Regulations: Department of Transportation regulations for safe transportation of biological materials within the United States

IATA Dangerous Goods Regulations: International Air Transport Association requirements for safe transportation of biological materials by air

IBC Requirements: Institutional Biosafety Committee requirements for review and oversight of research involving biological materials

IRB Requirements: Institutional Review Board requirements for research involving human subjects and biological materials

State Biosafety Regulations: State-specific requirements and guidelines for biological safety and containment

ABSA Guidelines: American Biological Safety Association professional guidelines for biological safety practices

GLP Standards: Good Laboratory Practice standards ensuring quality and integrity in non-clinical laboratory studies

HIPAA: Health Insurance Portability and Accountability Act - Federal law protecting sensitive patient health information from disclosure

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