Biosafety

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Policy on Biohazardous Materials in Research and Instruction

University of Massachusetts Amherst

Policy on Use of Biohazardous Materials in Research and Instruction 

Purpose

The University of Massachusetts Amherst (the University) is committed to ensuring the safe handling, storage, and disposal of potentially biohazardous materials, as defined below, used in University research or instructional projects.  This policy is designed to ensure that employees, students and visitors follow safe practices when working with or near potentially biologically hazardous materials or recombinant DNA.  The University will pursue biological safety through ensuring prudent practices to protect people and the environment from biological hazards and will conform to state and federal biosafety directives and guidelines.  Implementation of this policy by the University is intended to provide a safe working atmosphere and a well-controlled research environment. The University’s concern is for all biosafety issues but in particular it is concerned with activities involving

  • Infectious agents
  • Recombinant DNA research
  • Agents on the list of Select Agents
  • Potentially biologically hazardous materials

This policy statement describes the role of the University and the Office of Research Compliance (ORC), the Environmental Health and Safety Director (who is the Responsible Official with oversight over biosafety issues) and the Institutional Biological Safety Officer (BSO) in EHS, the Institutional Biosafety Committee (IBC), and the IBC’s structure and function.  The Biological Safety Officer and IBC are charged with reviewing and approving projects that need to comply with federal regulations on the use of recombinant DNA and Select Agents.  The review process is described below.

Definition

Biosafety promotes safe laboratory practices, procedures and proper use of containment equipment and facilities among University staff and visitors.

Biohazardous Material -

The following categories represent the areas of primary concern with respect to biosafety.  Projects involving material(s) included in any of these categories should be submitted to the BSO for initial review and may require IBC approval.

  1. Chemical Carcinogens used in conjunction with animals.
  2. Toxic/Infectious agents used in conjunction with animals and plants.
  3. Oncogenic viruses used in conjunction with animals.
  4. Infectious agents requiring handling conditions above Biosafety Level-1.(Biosafety Level determinations are based on the recommendations outlined by the CDC-NIH publication Biosafety in Microbiological and Biomedical Laboratories.
  5. Recombinant DNA
  6. Human blood and blood products, human body fluids, human tissue, and/or human cells.
  7. Biological toxins.
  8. Agents regulated by CDC or USDA (e.g. on the list of Select Agents)
  9. Whenever a contractual agreement or grant proposal requires Institutional Biosafety Committee approval for the safe handling of a biological or chemical product.
  10. Any research that requires a permit from USDA Animal and Plant Health Inspection Service (APHIS).
  11. Wild Poliovirus or materials that may contain wild poliovirus [contact Environmental Health and Safety (413) 545-2682 for additional information on this subject].

Policy

This policy applies to all research and instructional activities, sponsored and unsponsored, conducted under the auspices of the University. This policy is applicable to all University locations.  University projects involving the use of biohazardous materials at other institutions should receive Institutional Biosafety Committee (IBC) approval from the cooperating institution.  Copies of approvals from cooperating institutions should be forwarded to the Office of Pre-Award Services (OPAS) and the Office of Research Compliance (ORC) on request.

All University research and instructional activities involving biohazardous materials must be reviewed and approved by the Biological Safety Officer and, as required, the Institutional Biosafety Committee (IBC).  Projects submitted for sponsorship by external agencies will be submitted for review prior to acceptance of funding. The IBC review process is coordinated by the Research Compliance Coordinator in the Office of Research Compliance (ORC) in 109 Research Administration Building (545-5274).

Responsibility

Administrative heads of departments and other units have responsibility for the biosafety of people, and the environment within their jurisdiction.  Appropriate planning, provision of appropriate space and equipment, and training of personnel are essential in potentially biohazardous activities.

Principal investigators (PIs), instructors, supervisors and other personnel in charge of potentially hazardous activities are key to the biosafety effort.  PIs must set an example by their own actions to ensure compliance with the regulations and the University’s biosafety policy, directives and guidelines regarding the work they supervise.  They must report biologically hazardous incidents to the Biological Safety Officer (BSO) promptly and assist in any resulting decontamination, investigation and/or reporting that may be required.  They are responsible for posting biohazard warning signs at the entrance to the laboratory.  They are responsible for notifying the Office of Research Compliance of any proposed activity using biohazards by indicating so on the Kuali Questionnaire that accompanies a grant proposal submitted to the Office of Pre-Award Services (OPAS). They are responsible for making the initial determination of the required level of physical and biological containment in accordance with National Institute of Health (NIH) and Center for Disease Control (CDC) Guidelines. Once the project starts they are responsible for reporting any significant problems to the appropriate authorities (BSO, and/or Greenhouse or Animal Care Director as appropriate).  It is the responsibility of the PI to ensure that copies of approval letters are properly directed to any funding agency or sponsor. It is also the PI’s responsibility to renew approved projects with the ORC and provide a current listing of personnel involved in approved projects to the ORC.

All personnel involved in potentially biologically hazardous activity share biosafety responsibility and must follow specified procedures, take appropriate training, act responsibly, and report incidents and hazardous circumstances. They should inform their supervisor of any personal condition such as illness, medications, pregnancy, or reduced immunity which could make their work more hazardous to themselves and others.

The Biological Safety Officer (BSO) is appointed by the University and is a member of the EHS staff.  The BSO who is charged with oversight of research and other activities involving the use of biohazardous materials.  The EHS Director is the Responsible Official for biosafety issues and the BSO is his/her Alternate as required by the Homeland Security Act.  The Director of EHS and the BSO set containment levels in accordance with the National Institute of Health Guidelines and the Center for Disease Control Prevention.  The BSO reports any violations of the NIH Guidelines to the Responsible Official and the Institutional Biosafety Committee.  The BSO and other EHS personnel maintain an inventory of all potentially biologically hazardous materials, including Select Agents.  EHS records include a biohazard’s nature, location, and the Principal Investigator(s) involved.  The BSO is responsible for:

  • advising and training the Institutional Biosafety Committee members, faculty and staff concerning biologically hazardous materials and their control
  • reviewing (or pre-reviewing for the IBC) registrations of rDNA and Select Agents
  • inspecting facilities
  • reviewing and inspecting biologically hazardous activities in coordination with other EHS personnel and activities, the Animal Care Director, Greenhouse Managers, and the Compliance Coordinator in the Office of Research Affairs
  • providing technical advice to investigators on laboratory containment facilities, safety equipment, security and research safety procedures
  • developing emergency plans for containment and handling spills and personnel contamination
  • investigating accidents involving biologically hazardous materials. 

The Research Compliance Coordinator (CC) is a professional staff member in the Office of Research Compliance (ORC).  The CC works closely with the BSO and EHS Director to ensure that research with biologically hazardous materials and organisms at the University is conducted in accordance with all applicable local, state and federal regulations.  The CC and staff in the Office of Research Compliance have responsibility for:

  • managing the rDNA and Select Agent registrations database
  • managing the registration review process and interfacing with the BSO and the IBC for registration review
  • taking IBC meeting minutes
  • recording registrations submitted and actions taken
  • providing administrative support to the IBC and BSO
  • notifying the principal investigator of the outcome of a registration review
  • filing the IBC Annual Report for the University of Massachusetts Amherst with the NIH/Office of Biotechnology Activities
  • reporting oversight activity to the IBC when, according to State and Federal Regulations, the activity does not require the committee’s direct oversight
  • interfacing between the BSO and the IBC and other University oversight committees like the Institutional Animal Care and Use Committee (IACUC) and the Institutional Review Board (IRB).  The CC attends meetings of all three committees.

The University is responsible for

  • establishing an IBC and appointing the IBC Chair
  • ensuring that the IBC members, the BSO, the CC, PIs and laboratory staff have appropriate expertise and training
  • ensuring that an Annual Report is filed with the NIH Office of Biotechnology Activities and that the report includes (1) a roster of IBC members indicating their expertise; and (2) biosketches of the members.  [The Institution has an Approval on file with the NIH/Office of Biotechnology Activities.  The Approval must be renewed annually.  The expiration date for the current Approval is July 29, 2013.] 
  • establishing procedures for the IBC
  • Handling requests for copies of  IBC documents.

The Institutional Biosafety Committee

The Institutional Biosafety Committee (IBC) is a University-wide review body appointed by the Vice Chancellor for Research and Engagement to review and approve potentially biohazardous research. When it is unclear as to whether a material constitutes a potential biohazard, questions should be directed to the BSO in the Office of Environmental Health and Safety (EHS) (545-2682). 

Note: In the past the University had two standing committees to oversee rDNA, and pathogens,oncogenes, carcinogens and toxins. These activities are now combined, as reflected by the IBC’s charge which encompasses:

  • Review of policies, programs and directives regarding biological hazards in academic, research, clinical and animal care activities. 
  • Review and approval of research that involves potentially biohazardous materials (plant and animal pathogens, oncogenes, carcinogens, toxins and recombinant DNA), as required by University, State and Federal directives.  Review includes: (i) an independent assessment of the containment levels required by the NIH guidelines for the proposed research, (ii) assessment of the facilities, procedures, practices and training and expertise of the personnel involved in rDNA research, and (iii) ensuring compliance with all reporting and adverse event reporting required by the NIH guidelines.  The committee may approve, disapprove, or request revisions which would lead to approval.
  • Advising the Administration regarding problems of a biologically hazardous nature and recommending actions.  Recommendations include: denial of proposed activities where adequate facilities, equipment or personnel are not available; sanctions against individuals who are non-cooperative in biosafety matters; suspension of any biohazardous activity judged to pose a significant risk to health of safety.
  • Review of emergency plans covering spills and personnel contamination resulting from rDNA research and research using biohazards.

IBC members are appointed for three-year terms to provide oversight over University operations and activities of a potentially biologically hazardous nature.  Membership of the IBC is consistent with NIH guidelines (sections IV-B-2-a and IV-B-2-b) on the review of projects involving the use of recombinant DNA and its make-up has been reviewed and approved by the NIH/Office of Biotechnology Activities.  The BSO is a member of the committee and the other members work closely with the BSO to recommend actions necessary to maintain and/or improve biosafety on the campus.  The IBC meets at least four times a year.  A quorum consists of a simple majority.  Minority views are recorded in the minutes.

Procedures

PIs conducting research with biohazardous materials must register with the BSO. 

Grant-funded research:  PIs proposing research that uses biohazardous materials must indicate the category on the Kuali Questionnaire.  When one or more of the following items are checked

  • biohazardous substances
  • carcinogenic substances
  • recombinant DNA
  • Select Agents

a copy of the proposal is forwarded from the Office of Grants and Contracts to the Office of Research Compliance.  When the research involves biohazardous or carcinogenic substances a copy of the proposal is forwarded to the BSO for review.  The BSO contacts  the PI and requests that he/she submit the appropriate form (EH&S Research Registration Form) to ensure that the procedures are in compliance with all relevant regulations. The BSO will forward registrations for biohazardous work at BSL2 & 3 to the IBC for review. 

Non-funded research and teaching activities:  Requirements for registration and review by the BSO/IBC are the same as for funded research.

When the research involves work with rDNA and/or Select Agents the ORC assistant reminds the PI to submit the appropriate form (rDNA registration or Select Agent registration) for review by the IBC.  The completed rDNA or Select Agent registration is returned to the Office of Research Compliance. where the information is entered into a database then forwarded to the BSO.   For work registered at Levels III-F and III-E the PI may begin the project prior to receipt of formal approval.   For work registered at Level III-D formal written approval must be received before the project can be started.  

For Select Agents registration the BSO follows up with the PI to ensure that all aspects of Homeland Security and the Patriot Act and other regulations are complied with including:

  • whether or not the Select Agents are exempt from registration with the CDC
  • justification of the type of Biological Agent, Toxin or Delivery system to be used
  • assurance that  “Restricted Persons” and/or unauthorized persons will not have access to the Select Agents
  • how the Select Agents will be secured and be controlled when not in storage
  • the locations where the Select Agents will be stored and used
  • disinfection and disposal methods

If the project is to be conducted in a University laboratory, the BSO contacts the PI and schedules an inspection of the site(s) where the research will be conducted.  If the research also needs review and approval by the IACUC or IRB, approval by these committees is withheld pending approval of the project by the BSO/IBC and an assurance from the BSO that procedures are in place to ensure the safety of any personnel that will come in contact with the biohazardous materials, including laboratory staff and students, and animal care or greenhouse technicians.

Note: The BSO will advise the PI regarding the need for a written Safety Protocol.  A written Safety Protocol is required for projects where the biohazardous material comes in contact with animals and animal care staff.

Approvals are for a maximum of five years. 

Records for the IBC and a database of BSO-approved protocols are maintained in the ORC. Laboratory inspection records, training records, and the inventory are maintained by EHS.

Disposal of Biohazardous Waste

All biohazardous waste must be disposed of in accordance with local, state and federal regulations  Biohazardous waste must be collected in a bag with the biohazard symbol marked on the bag.  Bags must be kept in a sturdy, covered, leak-proof container.  Biohazard waste must be decontaminated by autoclaving, disinfection, or incineration. Waste that cannot be decontaminated by laboratory personnel will be removed from the area by EHS personnel for disposal, shipment, or destruction in accordance with applicable regulations. Sharps waste must be collected in “sharps”containers and removed by EH&S personnel in accordance with applicable regulations. Refer to the EH&S Biohazardous Waste Packaging Guidelines.

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Office of Primary Responsibility:                                                           Subject:

Vice Chancellor for Research and Engagement                       Institutional Biosafety Committee

 

1.0 Purpose

The University of Massachusetts Amherst (the University) has an Institutional Biosafety Committee (IBC) in compliance with the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines, 2002) and in accordance with Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition, 2007.   The following sections describes the University’s policy and procedures for the IBC

 

2.0 Policy

The IBC follows NIH Guidelines for practices for reviewing projects that require constructing and handling:  (i) rDNA molecules, and (ii) organisms and viruses containing rDNA molecules.  The IBC also reviews activities involving use of Select Agents and Toxins and other biohazardous agents that must be handled at BSL3 and 4.  The IBC will assist the Biosafety Officer (BSO) in the Department of Environmental Health & Safety (EH&S) in formulating policies and procedures related to the use of biohazards.  The IBC is also charged with reviewing the biological and medical waste management program annually according to The Department of Public Health’s regulation on the minimum requirements for the management of medical and biological waste CMR 480.000  The IBC may advise the institution and the Principal Investigator (PI) concerning management of research that is classified as “dual use”.

3.0 Procedure

3.1          IBC members are appointed by the Vice Chancellor for Research and Engagement for 3-year terms.  At the end of a member’s term he/she may be reappointed for a further term.

3.2          IBC membership conforms to NIH Guideline IV-B-2-a-(3). 

3.3          The IBC meets no less than four times a year for review of projects using rDNA that require review at NIH review level IIIE and higher, or for any other matter within the scope of the committee.  A meeting is conducted in person or via conference call.  A quorum is a majority of the membership. When possible, and consistent with the protection of privacy and proprietary interests, IBC meetings are open to the public. 

3.4          The Research Compliance Coordinator serves as Executive Secretary to the IBC including preparation of IBC minutes and filing reports with OBA.  Annual Reports to OBA are filed on or before the anniversary of the previous Annual Report.  Reports of significant problems or violations are reported to OBA within 30 days of the incident

3.5          An IBC member may not be involved in the review of any project in which he/she or a close relative or  spouse has a personal or financial interest.

3.6          The IBC may approve a registration for a period of up to 5 years. 

3.7          The PI is notified in writing that a registration has been approved by the IBC.  The approval letter includes the registration number, expiration date, and any other pertinent information and special approval conditions.  Approval letters for reviews conducted at NIH review level IIIE may be signed by the Executive Secretary.  All other approval letters are signed by the IBC Chair.

3.8          The IBC has been granted authority to investigate potential violations or compliance problems related to its area of oversight

3.9          Requests from members of the public for documents relating to IBC activities are handled in accordance with provisions of the Massachusetts Open Records Law (M.G.L. c. 66, § 10) and University policy for handling requests for documents related to research.  The University policy documents a process for review and redaction of research records before they are sent to a requestor.  The institution’s response to a request for records is handled in consultation with Legal Counsel.  The Vice Chancellor for Research and Engagement responds to the request.

 

Approved by Vice Chancellor for Research and Engagement Michael Malone

 

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The Public Health Security and Bioterrorism Preparedness Act of 2002 and the USA Patriot Act of 2001 require that research institutions collect information regarding "select agents" and register their presence with the federal government. DHHS and USDA have issued separate but complementary regulations.

In order for the campus to comply with the New Select Agent Regulation (42 CFR 73) and Agricultural Bioterrorism Protection Act of 2002 (7CFR Pt 331 and 9CFR Pt 121) the use of any Select Biological Agents and Toxins, High Consequence Pathogens or Toxins, or Plant Pathogens, must be reported it at proposal submission and to Environmental Health & Safety (EHS).

The Patriot Act also prohibits "Restricted Persons" from possessing, shipping, transporting or receiving Select Agents and prohibits the possession of a "Biological Agent, Toxin or Delivery System" of a type or in a quantity that, under the circumstances, is not reasonably justified by a prophylactic, protective, bona fide research, or other peaceful purpose. The CDC Select Agent Program web site has a set of FAQs where you can learn more.

If you are proposing to use an agent on the list of Select Biological Agents and Toxins in your research you must file a Select Agent Registration Form with EHS. For more information, contact the Biological Safety Officer at EHS, at 545-2682.

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The Institutional Biosafety Committee protocol form can be found here.

The University has a Biological Safety Officer in Environmental Health and Safety and a federally mandated Institutional Biosafety Committe (IBC) , which includes faculty, the Biosafety Officer, the Compliance Coordinator, the Director of Animal Care, and community representatives. All research projects involving the use of rDNA  or synthetic DNA must be registered with the Office of Research Compliance which provides reports to the IBC. The Biological Safety Officer pre-reviews registrations and determines the level of IBC review required.  The review process is briefly summarized here:

Conducting IBC reviews of use of rDNA and synthetic DNA at UMass Amherst.

UMass Amherst is required by the NIH to ensure appropriate review of research involving the use of rDNA or synthetic DNA by the Institutional Biosafety Committee (IBC) in compliance with the NIH Guidelines for Research Involving Recombinant or Synthetic DNA Molecules.  OPAM post-award staff may hold back release of funding for research involving use of rDNA or synthetic DNA until they get confirmation from the Office of Research Compliance that a registration covering this research has been submitted for IBC review or is already on file.

Registrations must be submitted by UMass employees who satisfy the Faculty Senate Policy that defines a PI at UMass (Sen. doc. No. 09-032).

Each registration is pre-reviewed by the Biosafety Officer in EH&S to verify that the NIH review level indicated by the PI is correct and to ensure the registration is complete.  The IBC review process follows NIH Guidelines.

For review level IIIE, the IBC is notified of the registration as soon as the pre-review is completed and the research may start prior to the PI receiving notice of formal IBC approval. 

For higher NIH review levels (IIID to IIA), the work cannot start until the PI receives an approval letter signed by the IBC Chair.   

Approval is for 5 years after which  time a new registration must be submitted if the use of rDNA or synthetic DNA is to continue.

Synthetic DNA in PCR products that are not clones is exempt from registration with the IBC.  However, use of commercially available nucleic acid molecules is not a determinant of exemption.

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