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Ames Procedural
Requirements

APR 8715.1

Effective Date: 4/17/2013
Expiration Date: 4/17/2018

COMPLIANCE IS MANDATORY

Ames Health & Safety Procedural Requirements

Chapter 52 - Biosafety

Table of Contents

52.1 Responsibilities
52.2 General Requirements
52.3 Process for Obtaining Institutional Biosafety Committee Review
and Approval for Use of Risk Group 2 Materials
52.4 Biosafety and Facility Design
52.5 Training, Instruction and Personnel Qualifications

Appendices

Appendix A. Definitions
Appendix B. Acronyms
Appendix C. References

This APR establishes the roles, responsibilities, and procedures for implementing a biosafety program as required by NPR 1800.1C, NASA Occupational Health Program Procedures. These requirements address the use of genetically-modified agents or recombinant DNA molecules or Biosafety Level 2 (BSL-2) or higher agents and A-BSL (or higher) animals in support of NASA research operations. This APR provides Center direction that should be used in conjunction with the referenced statutory, regulatory, and NASA agency requirements.

52.1 Responsibilities

52.1.1 Responsibility for safe use of biohazardous materials shall be generally the same as safety responsibility defined in APR 1700.1 Chapter 2, Safety and Health Responsibility, except as modified or augmented in this section.

52.1.2 Safety, Health & Medical Services Division

52.2.1 The Occupational Safety, Health and Medical Services Division shall:

  1. Serve as management sponsor of the Center’s Institutional Biosafety Committee.
  2. Monitor compliance to NASA policies and all applicable governing regulations, laws and guidelines that pertain to biological hazards.
  3. Designate a Biosafety Officer who shall serve as a member of the Institutional Biosafety Committee and advise laboratory supervisors regarding compliance with the requirements of this chapter.

52.1.3 Institutional Biosafety Committee

52.1.3.1 The charter of the NASA Ames Research Center Institutional Biosafety Committee shall be to protect the health of workers and the public at Ames from the risks associated with the use of hazardous biological agents, by ensuring that appropriate hazard controls are established for specific research projects.

52.1.3.2 The Ames Research Center Institutional Biosafety Committee shall:

  1. Review and approve all proposed uses, operational tasks and containment controls of genetically modified agents or BSL-2 agents or animals prior to their use.
  2. Develop guidelines to implement NASA requirements for risk assessment, project safety plans, medical clearance, and training where genetically-modified agents or pathogenic agents are used.
  3. If requested, review and advise on safety requirements for proposed facility designs and equipment for use with genetically-modified agents or Biosafety Level 2 (BSL-2) agents and A-BSL animals before the facilities are built or purchases are made.

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52.1.4 Supervisors

Supervisors who control work involving genetically modified agents or recombinant DNA molecules or BSL-2 agents or animals shall:

  1. Ensure that all biohazardous work is conducted in accordance with NASA policies, NIH Guidelines, and all applicable regulations.
  2. Prepare Laboratory Safety Plans as defined in APR 8715.1 Chapter 13, Chemical Hygiene, and document in those plans the hazards, risk assessment, hazard controls, medical monitoring, and training to be provided where genetically-modified or pathogenic agents are used
  3. Ensure that medical monitoring and clearance requirements are maintained for employees who handle genetically-modified or potentially pathogenic agents, including human body fluids and tissues, blood borne pathogens, and other potentially infectious material
  4. Ensure that employees who work with genetically-modified agents or pathogenic agents receive appropriate training and supervision

52.1.5 Contractors

52.1.5.1 Contractors shall comply with the review process defined in this chapter.

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52.2 General Requirements

52.2.1 Risk Group 3 and Risk Group 4 materials are prohibited on site.

52.2.2 Risk Group 2 materials shall be used only after receiving approval of the Institutional Biosafety Committee.

52.2.3 Risk Group 1 materials shall be used in accordance with a Laboratory Safety Plan approved by a Branch Chief or higher government official.

52.2.4 The determination of the appropriate risk group shall be based on Appendix B of NIH Guidelines (Classification of Human Etiologic agents on the basis of Hazard), subject to review by the Institutional Biosafety Committee.

52.2.5 Minimum hazard controls shall be those specified by the NIH guidelines.

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52.3 Process for Obtaining Institutional Biosafety Committee Review and Approval for Use of Risk Group 2 Materials

52.3.1 Submit the following documents to the Chair of the Institutional Biosafety Committee:

  1. Research proposal or grant application
  2. Laboratory Safety plan
  3. Qualifications and experience of the principle investigator
  4. List of specialized hazard control equipment to be used (e.g., biosafety cabinets, autoclaves)
  5. List of biological materials to be acquired
  6. Characterization of hazardous wastes to be generated during the performance of the proposed work

52.3.2 The Institutional Biosafety Committee shall review the submitted documents.

52.3.3 The Institutional Biosafety Committee shall inspect the site for the proposed work.

52.3.4 The Institutional Biosafety Committee shall meet to discuss the proposed work and decide by majority vote of a quorum of the committee members whether or not to approve the proposed work.

52.3.5 The Institutional Biosafety Committee shall document the decisions made and instructions provided in a memorandum to the applicant.

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52.4 BioSafety and Facility Design

52.4.1 Designs for new or modified facilities to house research animals or conduct research using biohazardous materials shall meet the performance, structural, mechanical, and electrical design requirements provided in NIH Guidelines.

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52.5. Training, Instruction and Personnel Qualifications

52.5.1. Each worker who may be exposed to biologic hazards shall be informed of potential hazards and hazard controls.

52.5.2. Specific training requirements shall be documented in the applicable laboratory safety plan, including:

  1. Minimum level of classroom training in microbiology safety, blood borne pathogens and other potentially infectious material
  2. Requirements for hands-on training for specialized laboratory procedures
  3. Requirements to demonstrate proficiency in the practices and techniques required for handling biological materials safely.

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Appendix A. Definitions

  1. Biosafety Level: See Risk Group.
  2. Risk Group: A designation that defines the principal hazardous characteristics of agents that may be present in biological found in Appendix B of NIH Guidelines (Classification of Human Etiologic agents on the basis of Hazard)
  3. Risk Group 1: Agents that are not associated with disease in healthy adult humans
  4. Risk Group 2: Agents that are associated with human disease that is rarely serious, and for which preventive or therapeutic interventions are often available
  5. Risk Group 3: Agents that are associated with serious or lethal human disease for which preventative therapeutic interventions may be available (high individual risk but low community risk)
  6. Risk Group 4: Agents that are likely to cause serious or lethal human disease for which preventative therapeutic interventions are not usually available (high individual risk and high community risk)

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Appendix B: Acronyms

BSL Biosafety Level
DNA Deoxyribonucleic acid
NIH National Institutes of Health

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Appendix C. References

  1. APR 1700.1 Ames Safety and Health Manual Chapter 2, Safety and Health Responsibility
  2. APR 8715.1 Ames Safety and Health Manual Chapter 13, Chemical Hygiene Program
  3. NASA NPR1800.1C, NASA Occupational Health Program Procedures.
  4. Biosafety in Microbiological and Biomedical Laboratories, Centers for Disease Control and prevention/National Institutes of Health, 5th ed. U.S. Government Printing Office, 2009.

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