麻豆国产AV

Introduction

The purpose of the Biosafety Program is to protect all employees, students, the public, as well as the environment from exposure to biological agents or materials being used at the 麻豆国产AV College that may cause disease or be harmful to humans. This manual provides a comprehensive overview of proper work practices, regulations, and requirements for proper use, containment and disposal of biological hazards.

I. Policies

麻豆国产AV College is committed to providing a healthy and safe learning, teaching, research, and work environment. The goals of the College’s Biological Safety Program are to:

• Ensure a healthy and safe research environment
• Protect staff, students, and the community from exposure to infectious agents
• Prevent environmental contamination
• Secure experimental materials
• Comply with the most recent versions of the National Institutes of Health “Guidelines for Research Involving Recombinant DNA Molecules” (NIH Guidelines), the US Department of Health and Human Services “Biosafety in Microbiological and Biomedical Laboratories” (HHS Biosafety), and other appropriate local, state and federal regulations.

This Biological Safety Manual has been developed to provide the College with safety guidelines for working with biological hazards. It also outlines general policies and procedures for using and disposing of infectious or potentially infectious materials. This document is a guidance document that will change in response to changes in existing regulations and inclusion of new regulations. It may not address all hazards that could be encountered by faculty, students, staff, and the surrounding community.

Biological safety practices and procedures in all 麻豆国产AV College laboratories must comply with those outlined in this manual. Principal investigators, laboratory supervisors, or laboratory managers must contact the Biosafety Committee or the Office of Environmental Protection, Safety and Sustainability if they are uncertain how to categorize, handle, store, treat, or discard any material.

II. Definitions, Rules, and Regulations

Biohazard Definition

Biohazards include infectious or disease causing agents of humans, animals and plants, toxins of biological origin, human-derived materials, recombinant DNA and any materials potentially containing infectious agents or biohazards. Biohazardous agents may include but are not limited to: Certain bacteria, fungi, viruses, rickettsiae, chlamydiae, parasites, recombinant products, allergens, cultured human or animal cells and the potentially infectious agents these cells may contain viroids, prions and other infectious agents as outlined in laws, regulations, or guidelines.

Rules and Regulations

The following is a brief summary of the regulatory authorities that either regulate or provide guidelines for the use of biological materials, infectious agents and recombinant DNA molecules. Copies of these documents are available.

National Institute of Health (NIH): Guidelines on Research Involving Recombinant or Synthetic Nucleic Acid Molecules

These guidelines address the safe conduct of research that involves construction and handling of recombinant DNA molecules and organisms containing them. A recombinant DNA Advisory Committee (RAC) was established in 1974 to determine appropriate biological and physical containment practices and procedures for experiments that potentially posed risks to human health and the environment. As a result of the committee’s activity, the initial version of the NIH Guidelines was published in 1976. It has been amended and revised many times since then. Included in the Guidelines is a requirement for the institution to establish an Institutional Biosafety Committee (IBC) with authority to approve or disapprove proposed research using the NIH Guidelines as a minimum standard. For more information, please refer to the web site above.

The Centers for Disease Control and Prevention (CDC) and the National Institute of Health (NIH) published the first edition of the BMBL in 1984. This document describes combinations of standard and special microbiological practices, safety equipment, and facilities that constitute Biosafety Levels 1-4, which are recommended for working with a variety of infectious agents in various laboratory settings. This document also outlines requirements for animal biosafety levels. The BMBL has been revised several times and is commonly seen as the standard for biosafety. For more information, please refer to the web site above.

HHS published a set of rules that require facilities and institutions to be registered and approved in order to transfer or receive certain biological agents and toxins. As most of these agents are BSL 3 or 4, they are not permitted at 麻豆国产AV College; nevertheless, we provide this information and web site to identify these agents. For more information, please refer to the website above.

III. Roles and Responsibilities

麻豆国产AV Institutional Biosafety Committee

The role of the 麻豆国产AV Institutional Biosafety Committee (HIBC) is to protect our community and environment from exposure to biological agents or materials in teaching or research laboratories that may cause disease or be harmful to humans. We will also provide advice and recommendations regarding the use of biological agent protocols and procedures for safety and compliance with federal guidelines and regulations.

The HIBC is composed of members of the 麻豆国产AV and surrounding community based upon their expertise. The HIBC will meet at least once a semester to review protocols and will be available to consult with members of the community regarding new protocols and procedures. Minutes will be recorded for all meetings and are available upon request. No member of the HIBC may be involved in the review in which she/he is or is expected to be involved. All HIBC meetings will be posted on the 麻豆国产AV College website and other members of the 麻豆国产AV community or outside community members are welcome to attend HIBC meetings. Any public comments made on the HIBC actions will be forwarded to the NIH Office of Science Policy.

The full HIBC (not a subcommittee) is responsible for the approval or disapproval of protocols, makes recommendations for protocol improvements, and promotes the development of protocols. All recombinant DNA research must be registered with the HIBC (exempt or non-exempt). The committee is the link between 麻豆国产AV College and regulatory agencies, and reports, as required, to regulatory agencies and will directly notify PIs of the committee review. If it is not possible to comply with the regulations, the HIBC will stop further teaching or research. Furthermore, the NIH Office of Science Policy will be notified if any significant incidents, violations, accidents or illnesses occur.

All teaching and research with specific biological materials must have protocols registered with the HIBC for review and approval. Materials that must be registered include all transgenic organisms, recombinant DNA, human blood or tissues, or other potentially biohazardous materials. HIBC has overlapping roles with other college committees, including the Institutional Review Board and the Institution Animal Care and Use Committee, and will communicate with them when necessary and appropriate.

The 麻豆国产AV College Institutional Biosafety Committee is currently composed of the following members: Siobhan Robinson, Chair of HIBC (Assoc Prof. of Psychology & Neuroscience, 麻豆国产AV College), Amani Jayakody (Assist. Prof. of Physics, 麻豆国产AV College), Michael Welsh (Assist. Prof. of Biology, 麻豆国产AV College), Brian Hansen (Director of Environmental Protection, Safety & Sustainability, 麻豆国产AV College), Jonathan Cordeiro (Principal Scientist, ICON Bioanalytical Laboratories), and Jessica Thomas (Prof. of Biology, Utica University). All members of the HIBC are appointed for a 3-year term by the Dean of the Faculty, 麻豆国产AV College.

Office of Environmental Protection, Safety and Sustainability

The Office of Environmental Health Protection provides instruction and training on safe work practices, conducts routine inspections of work areas, investigates accidents and recommends preventative/ corrective actions, and responds to emergencies.

Principal Investigators

The Principal Investigator (PI) is responsible for full compliance with approved research protocols, training required by the College, the Biological Safety Manual, and all local, state, and federal guidelines that apply to their research. The PI must complete and submit a biosafety research protocol application to the 麻豆国产AV Institutional Biosafety Committee for approval for all new research involving hazardous biological materials prior to the start of their research and shall not initiate any activity without receiving a response from the Institutional Biosafety Committee first. Modification of an activity covered by an Institutional Biosafety Committee approved protocol must also be approved by the Institutional Biosafety Committee before taking place. The PI is responsible for all personnel engaged in activities in their laboratory and must provide training to all of their staff and students on safe work practices. The PI shall report any spill or contamination to the Office of Environmental Protection, Safety and Sustainability. The Principal Investigator, together with the Office of Environmental Protection, Safety and Sustainability and other appropriate college officials, will direct cleanup procedures.

Employees and Students

Laboratory staff and students are responsible for following the principal investigator’s instructions. All personnel working with potentially infectious materials must be familiar with the College’s training requirements as well as the Biological Safety Manual. Staff and students must understand how to work with potentially infectious agents, be provided and wear the necessary PPE, keep their lab space clean, and follow regulations set forth about the handling and disposal of infectious waste.

IV. Biological Risks

This section includes those biological agents known to infect humans as well as selected animal agents that may pose theoretical risks if inoculated into humans. Included are lists of representative genera and species known to be pathogenic; mutated, recombined, and non-pathogenic species and strains are not considered. Non-infectious life cycle stages of parasites are excluded. View a comprehensive list of guidelines on the NIH website.

General Biohazardous Agents

The following agents are of general concern and include human pathogens, plant and animal pathogens, biological toxins, prions, recombinant DNA, and other select agents, animals, and cell lines.

Biosafety Levels

Biosafety levels are intended to allow the most protection for the workers, occupants in the building, public health, and the environment when handling specific microbial agents. Each level of containment specifies the microbiological practices, safety equipment, and facility design for the corresponding level of risk associated with handling a particular agent. The four different biosafety levels (BSL) are explained below (Table 1).

Table 1. Biosafety Level Classifications

Risk Group Classifications

There are three primary hazardous characteristics associated with any biological agent. These characteristics include:

• The capability of an agent to infect and cause disease in a susceptible human or animal host.
• The virulence of an agent as measured by the severity of disease.
• The availability of the preventative measures and effective treatments for the disease.

A standardized methodology was developed to classify biological agents into four different risk groups by also taking transmission routes into consideration. Four Risk Group (RG) Classifications are explained below (Table 2).

Table 2. Risk Group (RG) Classifications

Human Cells and Tissues

Human and non-human primate cells should be handled using Risk Group 2 (RG-2) practices and containment. All work should be performed in a biosafety cabinet and all material should be decontaminated by autoclaving or disinfection before discarding. Appropriate training in the handling of blood-borne pathogens and up-to-date hepatitis B vaccinations may be required.

Select Agents and Toxins

Select agents are specific pathogens and toxins that have the potential to pose a severe threat to public health and safety as defined by the USA PATRIOT Act and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. 麻豆国产AV College must be registered with the CDC and/or USDA before these materials are obtained, used, or stored.

Recombinant DNA (rDNA)

Recombinant DNA (rDNA) includes molecules that are constructed or synthesized outside living cells by joining natural or synthetic DNA segments of DNA molecules that can replicate in a living cell. They may also result from the replication of such construction DNA molecules. rDNA also includes synthetic DNA segments which are likely to yield a potentially harmful polynucleotides or polypeptides and are considered as equivalent to their natural DNA counterpart. If the synthetic DNA segment is not expressed in vivo as a biologically active polynucleotide or polypeptide product, it is exempt from the NIH guidelines. Human gene transfer studies, creation of transgenic rodents, cloning genes using plasmids, and generating and use of vectors to deliver genes are considered types of work with rDNA.

V. What must be registered with HIBC

Any experiment involving one or more of following must be registered with the HIBC:

• Pathogens affecting humans, animals or plants.
• Materials potentially containing human pathogens (for example, unfixed human specimens, human blood).
• Recombinant DNA molecules including virus vectors. Note: use the reference chart below (Figure 1) to determine which recombinant DNA experiments must be registered with NIH and or HIBC, and when.
• Work that does not qualify under NIH Guidelines Appendix CI-IX
• Human cell lines that are not well-characterized or require Risk Group 2 containment
• Generation of de novo transgenic animals, defined as the addition of foreign DNA or subtraction of a portion of the animal genome using recombinant DNA technology. The breeding of transgenic animals to generate additional transgenic offspring does not require IBC approval. Those transgenic animals that already exist or which have been purchased also do not require HIBC approval.
• All research involving the use of recombinant or synthetic nucleic acid molecules containing no more than two-thirds of the genome of any eukaryotic virus, or biohazards.
• Animal Subjects: All research involving the use of recombinant molecules or biohazards in whole animals requires both HIBC and IACUC approval.
• Human Subjects: Any research involving the introduction of recombinant molecules or biohazards into human subjects must be approved by the IBC and by the IRB.

Figure 1. Recombinant DNA Research Registration Checklist

This chart should be used as a reference to determine when your experiment must be registered with HIBC and/or NIH, and when.

VI. Training Requirements and Supplemental Courses

General Lab Safety Training

Lab safety training requirements are generally spelled out in accordance with other specified 麻豆国产AV College plans, including:

• The Hazard Communication Plan:
  For work with hazardous chemicals in lab settings
• The Chemical Hygiene Plan:
  For work with occupational and/or environmental hazards in lab settings
• The Waste Management & Minimization Plan:
  Which deals with waste handling, storage and disposal

The introduction and use of certain biological hazards into lab settings mandates additional training requirements, to both minimize lab acquired infections (LAI’s) and comply with this plan and other consensus and regulatory drivers. In general, employee/student use of and exposure to biological hazards at the BSL-1 level does not require additional training beyond that which is provided in accordance with the plans noted above, so long as such hazards are clearly stipulated in written lab hazard assessments.

BSL-2/BSL-2+ Training

Employee/student use of and exposure to biological hazards at the BSL-2/BSL-2+ level requires additional training to at a minimum cover the following:

• Laboratory Acquired Infections (LAI’s)
• OSHA Bloodborne Pathogens Standard:
  • When human blood, tissues or OPIM (other potentially infectious materials) are in use
• Vaccinations (i.e. Hepatitis B, Rabies, etc.)
• Sharps and centrifuge safety
• Engineering controls through biological safety cabinets (BSC’s)
• Animal handling and biosafety (where applicable)
• NIH guidelines for research involving recombinant or synthetic nucleic acid molecules

Additional required training will require completion of appropriate CITI Program Training modules.

VII. Guidelines for the safe use of biological hazards

The NIH and CDC specifies hazard levels, standard microbiological practices, safety equipment, laboratory facility requirements for standard laboratory experiments for using specific BSL agents. 麻豆国产AV College laboratory containment requirements and practices follow these guidelines for BSL-1, BSL-2 and BSL-2+ agents (only allowable agents at 麻豆国产AV College) and are outlined in the chart below.

A. Hazard Levels

B. Standard Microbiological Practices

C. Safety Equipment and PPE

D. Laboratory Facilities

This information has been adapted, in part and with permission, from Clarkson College and Skidmore Colleges' Institutional Biosafety Committee documents.