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ROWAN UNIVERSITY POLICY

Title: Laboratory Safety Policy
Subject: Research Integrity 
Policy No: 
Applies: 
Issuing Authority: 
Responsible Officer:
Adopted: 
Last Revision: 01/15/2015

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All questions related to laboratory safety should be directed to Environmental Health and Safety, 856 256-0000 or Office of Research, 856 256-0000.

III. APPLICABILITY

This policy applies to all laboratories being used for research or clinical purposes under the auspices of the University by all Schools/Units/Departments located in all Rowan University- owned, leased or operated facilities.

IV. DEFINITIONS

  1. Laboratory - a facility where relatively small quantities of hazardous chemicals or biological agents are used on a non-production basis for research or clinical purposes.
  2. Laboratory Personnel - employees, students and other persons conducting research and clinical activities in Rowan laboratories, regardless of Rowan University employment status.
  3. Particularly Hazardous Substance - any substance which meets the criteria defined in the PEOSH Laboratory Safety Standard of "select carcinogen," reproductive toxin, or substance with a high degree of acute toxicity (rat oral LD50 less than 50 mg/kg).
  4. Responsible Investigator - Rowan University faculty member who has been assigned or sharing laboratory space.
  5. Responsible Facility Official (RFO) - ensures management oversight of the transfer of select agents, consistent with the CDC Guidelines.
  6. Recombinant DNA and Synthetic Nucleic Acid Molecules - Consistent with the NIH Guidelines, recombinant DNA molecules are either: (i) 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 (ii) molecules that result from the replication of those described in (i) above.
  7. Select Agent - Select agents are specific pathogens and toxins as defined by Title 42 CFR Parts 73.4 and 73.5. Registration with the Secretary of the Department of Health and Human Services and approval by the Institutional Biosafety Committee is required before possession, use, and transfer of select agents and Toxins.

V. REFERENCES

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  1. The Public Employees Occupational Safety and Health Act, (PEOSHA) 29 CFR l9l0-l450, as implemented by the New Jersey Department of Labor, NJAC l2:l00-4.2

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  1.  The NIH Guidelines for Research Involving Recombinant DNA Molecules http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm.

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  1.  The Biosafety guidelines set out in NIH's publication "Biosafety in Microbiological and Biomedical Laboratories" http://www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf.

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  1.  Federal requirements for Facilities Possession, Use, and Transfer of Select Agents and Toxins, 42 CFR Part 73; Code of Federal Regulations, Title 42, Section, Part 72, Interstate Shipment of Etiologic Agents, Additional Requirements for Facilities Transferring or Receiving Select Agents. http://www.cdc.gov/phpr/dsat.htm.

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  1.  USA Patriot Act 2001, Public Law 107–56. http://www.gpo.gov/fdsys/pkg/PLAW-107publ56/html/PLAW-107publ56.htm.

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  1.  Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Public Law 107–188, (g) Guidelines of the Center for Disease Control.

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  1.  Department of Labor. Occupational Health & Safety. Code of Federal Regulations Title 29 - Labor; Subtitle B – Regulations Relating to Labor, Chapter XVII – Occupational Safety and Health Administration (DoL), part 1910 – Occupational Health and Safety Standards.

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  1.  Energy Restructuring Act of 1974, Nuclear Regulatory Commission Standards and Regulations. Department of Energy. Code of Federal Regulations Title 10 – Energy; Part 20 – Standards for Protection against Radiation.

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  1.  Prudent Practices in the Laboratory: Handling and Management of Chemical Hazards, Updated Edition (2011) Board on Chemical Sciences and Technology. National Research Council.

The following Rowan University Safety Manuals provide guidance for safe laboratory practices

  1. General Laboratory Safety manual.
  2. Biosafety Manual
  3. Chemical Hygiene Plan
  4. Blood borne pathogen Manual
  5. NJ Workers and Community Right-To-Know

VI. POLICY

Rowan University provides a comprehensive health and safety program for all University laboratories which is described in the Laboratory Safety Plan. The program will be coordinated with other University health and safety policies, including those outlined in Section II of this Policy to ensure comprehensive, customized and non-redundant coverage. Pursuant to this program, minimum laboratory safety standards, which comply with applicable Federal and State regulations and guidelines, are established in a written Laboratory Safety Plan for each School/Unit/Department. The exact requirements of such plans are decided by EH&S, in conjunction with representatives from each School/Unit/Department. The Laboratory Safety Plan contains minimum safety standards which apply to all University laboratories. In addition to the Laboratory Safety Plan, the Select Agents Program is described in this policy.

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  1. Requirements
    1. Laboratory Safety Plan:
      EH&S in collaboration with Office of Research shall establish a Laboratory Safety Plan for each School/Unit/Department. Each plan shall include all of the required components listed in this Policy Section VI and made available to all laboratory personnel who work in laboratories and/or who provide support services that involve laboratories. If desired, Schools/Units/Departments may use an alternative plan as long as it includes all of the components of this Policy Section VI as well as the Rowan University's Minimum Laboratory Safety standards. All such plans, including alternative plans, must be reviewed and updated annually by the School/Unit/Department, in conjunction with EH&S to reflect any pertinent changes.
    2.  Required Components of Plan:
      1. Establishing SOPs:
        Written procedures must be developed about common topics, such as working alone, vacating laboratories, conducting laboratory safety audits, storing chemicals, using refrigerators and cold rooms, allowing visitors in laboratories, and permitting unattended operations. Copies of such procedures will be available to all laboratory personnel, to EH&S and will be used in employee training.
      2. Controlling Exposure:
        Preventative measures must be designed to ensure that exposure of employees to chemical substances is minimized and kept within professionally recognized standards. Such measures will include an appropriate combination of engineering controls, work practices and personal protective equipment.
      3. Training:
        All employees shall receive initial and subsequent periodic instruction in those safety topics specifically described in the Laboratory Safety Plan. Training will be provided by EH&S and training records will be maintained by EH&S.
      4. Requiring Prior Approval:
        A prior approval process must be established for those activities, specified in the plan, which may pose an increased risk to laboratory personnel and others who may be present. Examples of activities which may require prior approval include working with a particularly hazardous chemical, or working alone during off-hours such as evenings, night and holidays.
      5. Ensuring Medical Consultation:
        Medical consultation attention must be available when laboratory personnel develop symptoms associated with exposure to hazardous chemicals, and/or when air monitoring indicates that laboratory personnel have received chemical exposures over regulatory limits, and/or when a spill or other incident results in an acute exposure.
      6. Personnel Working with Particularly Hazardous Substances:
        Special procedures must be established which set out requirements governing the use of particularly hazardous chemicals, as defined by this policy.
      7. Establishing Emergency Procedures and Equipment:
      Written
      1.  Written emergency procedures for fires, spills, exposures and other likely laboratory accidents must be written and prominently displayed. Emergency equipment such as fire extinguishers, safety showers, and eyewashes shall be readily accessible and kept in usable condition. EH&S will provide assistance in maintaining emergency equipment.
      2. Maintaining Properly Functioning Protective Equipment:
        Protective equipment, such as chemical fume hoods, safety showers, eyewashes, and biological safety cabinets shall be maintained and tested in accordance with any and all applicable regulations and with the manufacturer's recommendations. The Laboratory Safety Plan shall clearly specify who will be responsible for properly maintaining this equipment and for documenting in writing such maintenance. 
      3. Monitoring Exposure:
        Laboratory personnel who, either have been exposed or who exhibit symptoms consistent with exposure, shall be regularly assessed and monitored by Environmental & Occupational Health Support Services (EOHSS) in accordance with applicable regulations. Whenever possible, laboratory personnel will be notified of the results of monitoring within three (3) working days of the receipt of results. The PEOSH mandated maximum allowable time of fifteen (l5) days between receipt of the results and notification, shall at no time be exceeded.
      4. Keeping Records:
        Records of the Laboratory Safety will be maintained in the offices of EH&S. Records include training records, monitoring records, investigation and analysis and actions per university record keeping policy
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      B.
  2.  Responsibilities
    1. Select Agent Program:
      Select Agent Toxins are certain toxins of biological origin which are to subject to stringent regulatory requirements under 42 CFR 73 for their potential to pose a severe threat to public, animal or plant health or to animal or plant products. These toxins, along with specified biological agents (viruses, bacteria, fungi), fall under the oversight of the National Select Agents Registry (NSAR) Program http://www.selectagents.gov/Select%20Agents%20and%20Toxins.html. The Select Agents Program (SAP) at Rowan University ensures compliance with all applicable federal regulations (7 CFR Part 331, 9 CFR Part 121, and 42 CFR part 73) as well as the NIH Guidelines and the standards set forth in Biosafety in Microbiological and Biomedical Laboratories 5th ed. 
      Possession of any quantity of select agents, or nucleic acids that encode infectious/replication competent forms of the listed viruses, or functional forms of any of the listed toxins requires registration in the program. To register the use of select agents, users must contact EH&S. 
      This policy requires training, safe handling, use, and storage procedures. Effective tracking (receiving, shipping, and inventory control) and security of select agents and toxins and compliance with federal regulations (42 CFR Part 73). 
      A Principal Investigator (PI) and a Responsible Official (RO) ensure compliance with all aspects of biosafety, biosecurity and incident response. Researchers that handle the select agents or enter areas where they are stored must be Security Risk Assessment (SRA) approved, medically cleared, trained and have their competency assessed
      2. .
    3. Physical Plant: EH&S, in conjunction with Physical Plant, Facilities Planning and Construction (FP&C) and the Laboratory Safety Committee shall develop Minimum Laboratory Safety Design Guidelines for new/renovated laboratories. The architect/engineer affiliated with the project must bring potential departures from the guidelines to the attention of the Project Manager who shall ensure that it is brought to the attention of Physical Plant, EH&S and the end user and discussed at a planning meeting before being accepted. FP&C shall provide the Architect/Engineer with a copy of the guidelines in the beginning of the planning stage and shall advise them of the above requirement.