Office or Environmental Health and Safety

Draft

Recombinant DNA and BioHazard Policy

INTRODUCTION

Connecticut College adheres to the NIH Guidelines for Research Involving Recombinant DNA Molecules with regard to all uses of recombinant DNA within college facilities. Connecticut College requires that all use of recombinant DNA be registered with the Institutional Biosafety Committee (IBC), even if such use is exempt from the requirements of the NIH Guidelines.

I. DEFINITITIONS:

a. Biohazard - A biohazardous (etiological) agent is an infectious (pathogenic) substance produced from living organisms that has the potential for causing disease in other living organisms.

b. Recombinant DNA - The National Institutes of Health (NIH) define recombinant DNA (rDNA) molecules as “molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or molecules that result from the replication of those described above.” Synthetic DNA segments that are likely to yield a potentially harmful polynucleotide or polypeptide (e.g., a toxin or a pharmacologically active agent) are considered as equivalent to their natural DNA counterpart. All rDNA research as explained below must be conducted in compliance with the “ NIH Guidelines for Recombinant DNA Research”

II. APPLICABILITY:

a. If the synthetic DNA segment is not expressed in vivo as a biologically active polynucleotide or polypeptide product, technically, it is exempt from the NIH Guidelines. However, ALL recombinant DNA research at Connecticut College must be registered with, and reviewed by, the Institutional Biosafety Committee (IBC), regardless of the source of funding.

b. The guidelines affect rDNA research that is conducted or sponsored by an institution that receives funding from NIH, including research performed directly by NIH. An individual who receives support for research involving recombinant DNA must be associated with or sponsored by an institution that assumes the responsibilities assigned in the NIH guidelines.

c. The guidelines also include research, or participation in research that involves human testing of materials containing recombinant DNA developed with NIH funds (“participation” to include research collaboration and/or contractual agreements, and not mere provision of research materials).

III. PRINCIPALS OF BIOSAFETY

a. The CDC/NIH identify three basic principles of Biosafety:

i. Risk Assessment - It is the responsibility of the PI to assess the risk which the research poses to the health and safety of laboratory staff and the environment. Based on this risk assessment, the PI must ensure that the proper precautions as indicated in the CDC/NIH text: Biosafety in Microbiological and Biomedical Laboratories (BMBL) are followed.

ii. Containment - Containment is used to describe safe methods for managing infectious materials in the laboratory environment. The purpose of containment is to reduce or eliminate exposure of laboratory workers, other persons, and the outside environment to potentially hazardous agents.

iii. Biosafety Levels - Biosafety Levels (BSLs) use various elements of containment to ensure a safe laboratory environment when working with biohazardous or infectious agents. There are 4 biosafety levels:

1. Biosafety level 1: Least amount of protection and is used with well-characterized agents not known to consistently cause disease in healthy adult humans. Example: E. coli (non-pathogenic strain), infectious canine hepatitis virus. At least Biosafety Level 1 (BL1) lab practices should be used with all recombinant DNA work, even if the work is exempt from NIH Guidelines.

2. Biosafety level 2: Suitable for work involving agents of moderate potential hazard to personnel and the environment. Example: human tissue and blood, hepatitis B, HIV, adenoviruses. Attachment (a) is a summary of BL1 and 2 procedures and requirements. Additional information may be found in Appendix G of the NIH Guidelines .

3. Biosafety level 3: Suitable for work with infectious agents that may cause serious or potentially lethal disease as a result of exposure by the inhalation route. Example: M. tuberculosis, St. Louis encephalitis virus.

4. Biosafety level 4: Required for work with dangerous and exotic agents that pose a high individual risk of aerosol-transmitted laboratory infections and life-threatening disease. Example: Ebola virus, arenavirus, Marburg virus.

NOTE: Because of facility and security limitations, research requiring Biosafety levels 3 or 4 is not authorized at Connecticut College .

 IV. SELECT AGENTS:

a. The Public Health Security and Bioterrorism Preparedness Act of 2002 and the USA Patriot Act of 2001 require that academic and research institutions collect information regarding "select agents" and register and obtain approval for possession with the federal government. The Department of Health and Human Services (DHHS) and the U.S. Department of Agriculture (USDA) have issued separate but complementary regulations. Approval from the CDC is required prior to possession of any agent on the list of Select Biological Agents and Toxins, High Consequence Pathogens and Toxins, or Plant Pathogens. If you are proposing to possess any agent listed, you should anticipate a significant delay in obtaining approval due to extensive review of the application by the CDC and to stringent security requirements and procedures.

b. As previously stated, use or possession of agents requiring BL3 or 4 is prohibited at Connecticut College . All registration requests trigger a Center for Disease Control (CDC) security risk assessment. The CDC Select Agent Program web site has a set of FAQs where you can learn more. For other agents, there may be requests that the College cannot accommodate because of facility restrictions and security requirements.

V. INSTITUTIONAL BIOSAFETY COMMITTEE (IBC):

a. In accordance with the NIH Guidelines, an IBC must be established by all institutions conducting research involving rDNA or biohazardous agents (including all human blood/tissues laboratories). The IBC must be comprised of:

i. No fewer than five members, so selected that they collectively have experience and expertise in rDNA technology and the capability to assess the safety of recombinant DNA/Biohazardous research, and to identify any potential risk to public health or the environment.

ii. At least two of the members shall represent the community. (e.g., local health department officials.)

iii. At least one individual shall have expertise in plant, plant pathogen, or plant pest containment principles (when experiments utilizing Appendix P, Physical and Biological Containment for Recombinant DNA Research Involving Plants , require prior approval by the IBC.).

iv. At least one scientist shall have expertise in animal containment principles (when experiments utilizing Appendix Q, Physical and Biological Containment for Recombinant DNA Research Involving Animals , require IBC prior approval.).

v. A facility Biological Safety Officer (BSO) is mandatory when performing research at Biosafety Level-3 or above.

b. Responsibilities of the Connecticut College IBC:

 i. To establish, review, and revise guidelines under which research involving rDNA, biohazardous agents, carcinogens, and acutely toxic compounds is conducted at Connecticut College.

ii. To review all proposed research protocols involving rDNA, biohazardous agents, carcinogens, acute toxins and any other proposed procedures involving significant biohazardous risks.

iii. To periodically review all ongoing rDNA, high-risk chemical carcinogens, and biohazard research to ensure appropriate biosafety guidelines are followed.

iv. To advise the college of procedures and infrastructure that may be necessary to conform to established guidelines.

v. To maintain close and continuous association with the Office of Environmental Health and Safety, utilizing it as the main resource for providing consultation, laboratory inspections, monitoring, record keeping, and training.

vi. To identify chemical substances used in Connecticut College laboratories that may pose a carcinogenic and/or acute toxin exposure threat.

vii. To establish and review policies and procedures used for the control, processing, and disposal of regulated medical waste and hazardous chemical waste.

viii. To establish procedures for correcting violations in order to comply with applicable laws, regulations, and guidelines.

ix. To inform Connecticut College administrators whenever compliance deficiencies are revealed.

x. As required, the IBC will consult with appropriate individuals outside the committee.

VI. PRINCIPAL INVESTIGATOR RESPONSIBILITIES:

a. Registration of Research:

i. All research involving rDNA and biohazardous agents must be registered with the IBC. Registration with the IBC is accomplished through completing and submitting Attachment (b), the Connecticut College Gene Transfer, Recombinant DNA and Select Agent Registration Form.

ii. Initial and ongoing approval of the research project will be contingent upon the IBC review of Attachment (b), and annual laboratory certification through the biosafety inspection program.

iii. Principal Investigators (PI's) will be responsible for registering with the IBC and for following all applicable guidelines regarding recombinant DNA and biohazardous research.

iv. Failure to register rDNA and/or biohazardous research with the IBC or non-compliance with other regulatory guidelines may result in:

1. Suspension, limitation, or termination of financial assistance for the noncompliant NIH-funded research project and of NIH funds for other recombinant DNA research at the institution.

2. Requirement for prior NIH approval of any or all recombinant DNA projects at the institution.

3. Disciplinary action by college authorities, including loss of funding and/or restriction on research activities.

b. Laboratory Safety Procedures:

i. The PI is responsible for conducting risk assessments, and determining Biosafety Levels (BSLs) for all research conducted within laboratory spaces under their charge in accordance with the NIH Guidelines .

ii. The PI shall ensure the integrity of the physical containment (e.g., biological safety cabinets) and the biological containment (e.g., purity and genotypic and phenotypic characteristics).

iii. The PI is responsible for selecting and utilizing appropriate microbiological practices and laboratory techniques.

iv. The PI will educate all laboratory staff regarding the protocols that describe the potential biohazards and the precautions to be taken.

v. The PI shall instruct and train laboratory staff in: (i) the practices and techniques required to ensure safety, and (ii) the procedures for dealing with accidents, and inform the laboratory staff of the reasons and provisions for any precautionary medical practices advised or requested (e.g., vaccinations or serum collection).

vi. The PI is responsible for supervising the safety performance of the laboratory staff, to ensure that the required safety practices and techniques are employed.

vii. The PI will investigate any significant problems pertaining to the operation and implementation of containment practices and procedures, and report the findings in writing, to the Institutional Biosafety Committee.

viii. The PI shall remain in communication with the Institutional Biosafety Committee throughout the conduct of the project.

c. Training:

i. All laboratory personnel must complete the Biological and Laboratory Safety New Hire training course.

d. Animals and rDNA:

i. Investigators planning to administer recombinant DNA to animals should refer to Appendix Q and Section III-D-4 of the NIH Guidelines for information on biological and physical containment practices. Refer to the Connecticut College Laboratory Animal Safety Policy for institution specific information.

e. Human Gene Transfer Research Proposals:

i. If registering a human gene transfer proposal, please note that the proposal must be submitted to the Recombinant DNA Advisory Committee (RAC) of the NIH Office of Biotechnology Activities (NIH/OBA) for review. The RAC determination on the proposal must be obtained prior to the proposal receiving local Institutional Biosafety Committee (IBC) approval. NOTE: No research participant may be enrolled in a human gene transfer clinical study until the RAC review process is completed AND IBC and IRB approvals and applicable regulatory authorizations are obtained.

VII. BIOSAFETY INSPECTIONS:

a. Laboratories registered with the IBC for research involving rDNA and/or biohazardous agents will be subjected to periodic biosafety inspections by the Director of Environmental Health & Safety and/or the Connecticut Department of Public Health. Inspections will meet the following criteria:

i. All biohazard laboratory inspections will be performed per the requirements of the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL) manual. Attachment (c) is the Laboratory Inspection Checklist.

ii. All laboratory inspections will be conducted on a yearly basis and will be scheduled in advance whenever possible. However, unannounced random and follow-up inspections may also be conducted.

iii. Immediate life/property threatening violations and continuing violations revealed during the inspection process will be reported to the IBC.

iv. Following the completion of the biosafety inspection, a summary of findings and recommendations for corrective action will be provided to the PI.

Attachment (a): Summary of Biosafety Levels 1 & 2 for Infectious Agents
Attachment (b): Gene Transfer, Recombinant DNA and Select Agent Registration Form
Attachment (c): Laboratory Biosafety Inspection Form