The primary goal of the Biosafety Program is to facilitate the implementation of appropriate administrative policies, work practices, safety equipment, facility design and training programs for work involving biological hazards. The purpose of these functions is to minimize the risk of laboratory-acquired exposures and to promote full compliance with applicable biological safety regulations and guidelines.
The Biological Safety Program at Rensselaer provides oversight for research involving biological hazards such:
- Organisms classified as meeting BSL1 or greater criteria established in the Center for Disease Control’s BMBL 5th edition.
- Research involving recombinant DNA
- Research involving the use of human cells or cell cultures
- Select agents as defined by the CDC
For further information regarding Rensselaer's Biosafety Program, contact Magaly Montenegro Martinez by calling (518) 276-2092 or via email.
Biological Safety is, at present, principally governed by restrictions formulated by the CDC and NIH for research entities using various hazardous agents and processes. The Occupational Health and Safety Administration (OSHA) is using its powers of enforcement under the General Duty Clause to impose certain safety requirements on various aspects of biological safety programs.
Through the Vice President of Research and the department of EHS&RM, Rensselaer has developed guidelines and requirements for research involving potentially hazardous agents and processes. Further information for these requirements is available at the following two sources:
- Rensselaer Biosafety Manual
- Research Compliance - Biosafety in Microbiological and Biomedical Laboratories (BMBL)
Further guidance on the conduct of work when handling hazardous biological organisms is contained in the 5th edition of the BMBL, and researchers are strongly encouraged to become familiar with this document, especially the section on performing risk assessments. The risk assessments required by Rensselaer prior to the approval of the research will determine the engineering and work practice controls imposed for the research.
Specific program services may include:
- Communicate current biosafety regulations and guidelines to research personnel.
- Perform laboratory biosafety inspections to identify deficiencies and make recommendations to improve compliance and safety.
- Meet with new Principal Investigators to discuss biosafety compliance.
- Perform safety training including general biosafety, bloodborne pathogens, shipping biological materials, select agent compliance and site-specific biosafety training (as requested).
- Address all issues associated with select agent laboratory compliance.
- Provide biosafety technical expertise on topics such as disease transmission, risk assessments, disinfection and sterilization, lab operations, personal protective equipment and environmental controls.
- Provide guidance on the proper disposal of biohazard waste.
- Provide guidance on the selection, installation and use of biological safety cabinets and coordinate the annual certification of all biological safety cabinets.
- Provide guidance in the proper shipping of biological materials.
- Provide guidance and/or assistance with proper clean-up of biological spills.
- Investigate and provide follow-up for all reported work-related exposures to human blood, body fluids or other potentially infectious biological agents.
Policies and Procedures
Rensselaer Polytechnic Institute - Animal Care Policy
Before entering the Bio-Research Core facilities at Rensselaer Polytechnic Institute, users are provided with a health questionnaire, and a risk assessment is conducted to determine if a participant should be enrolled in the Occupational Health and Safety Program (OHSP).This enrollment is determined based on exposure of Renssealer faculty, staff and students who may, in the course of their employment, research, or education, be exposed to vertebrae animals in a way that puts them at increased risk of an illness or injury. The OHSP was developed in compliance with the Guide for the Care and Use of Laboratory Animals (National Research Council, eight edition), and Occupational Health and Safety in the care and use of Research of Animals (National Research Council, 1997).
In collaboration with the Bio-Research Core facilities, Rensselaer's Student Health Service, and the Institute Animal Care and Use Committee (IACUC), Rensselaer's department of Environmental, Health, Safety and Risk Management (EHS&RM) conducts reviews of risk assessments questionnaires, and determines and tracks participant enrollment in the OHSP. Participants are provided with training to prevent animal allergies, and animal exposure surveillance is offered to those participants (including students, faculty or staff) who have significant contact with animals according to the Animal Exposure Surveillance Program (AESO).
Contact the Bio-Research Core Animal users if you have questions related to risk assessments and management, personal training, preventive medicine and medical treatment if required.
- Student Health Service
- Environmental Health & Safety and Risk Management Office
- Bio-Research Core, Institutional Animal Care and Use Committee IACUC
- Rensselaer's Bio-Research Core Facility Animal users Occupational Health and Safety Policy and Program
- Institutional Biosafety Committee (IBC)
- Renssealer Polytechnic Institute Biosafety Program
- Rensselaer Polytechnic Institute Bloodborne Pathogens Program
- Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition
Regulatory Agencies Regulations
Rensselaer Polytechnic Institute
Standard Operating Procedure (SOP) for Controlled Substances
DEA Registration Requirements
- Every person or entity that handles controlled substances must be registered with DEA or be exempt by regulation from registration
Application for DEA Registration
- To obtain a DEA registration, a practitioner must apply using a DEA Form 224.
- Applicants may submit the form by hard copy or online.
- The DEA Certificate of Registration (DEA Form 223) must be maintained at the registered location in a readily retrievable manner and kept available for official inspection.
Application for New York State Department of Health, Bureau of Narcotic Enforcement License and Certification
- Submit a License Application to Engage in a Controlled Substance Activity (DOH-4330) to the DOH Bureau of Narcotic Enforcement (BNE). Applications are available via New York State's Department of Health/Bureau of Narcotic Enforcement website.
- Practitioner registrations must be renewed every three years.
Termination of Registration
- Any practitioner desiring to discontinue business activities with respect to controlled substances must notify the nearest DEA field office in writing.
- Practitioners are required to store stocks of Schedule II through V controlled substances in a securely locked, substantially constructed cabinet.
- Practitioners authorized to possess carfentanil, etorphine hydrochloride and/or diprenorphine, must store these controlled substances in a safe or steel cabinet equivalent to a U.S. Government Class V security container.
- All individuals authorized by the registrant to have access to scheduled substances must have an authorized agent form on file with the registrant.
- A log of all authorized agents will be maintained near the storage area.
Many orders for scheduled drugs will require the completion of a DEA form 222. These forms must include the following information:
Receipt and Storage
- All scheduled substances must be maintained in a substantially constructed cabinet or safe.
- Schedule 1 and 2 substances and their records must be kept separately from schedules 3-5.
- If receipt is being handled by an authorized agent and not the registrant, this process must be witnessed on the inventory log by a second authorized agent.
- Make sure the amount listed matches the amount delivered.
- If more than one vial or bottle is received in a shipment, it may be helpful for tracking purposes to assign each one a unique number.
- Enter the drug name, lot number or other unique Identifiers and the amount delivered in the appropriate drug log.
- If the order required a DEA 222 form, be sure to complete the DEA form and keep the form for a minimum of 2 years.
- For orders that did not require a DEA 222, keep a copy of the packing slip on file.
Removing drugs from the safe for use in the lab
- When checking a scheduled substance out from the safe, an authorized agent must have the withdrawal witnessed by the registrant or another authorized agent.
- Take only the amount needed for the experiments planned and be sure to record any waste/spillage on the inventory log.
- Label compounded solutions containing a controlled substance prepared within the laboratory.
- When using the drug, enter the amount used for procedures performed immediately after the procedures have been completed.
- Make sure the amount of drug used, the purpose for using the drug, and the amount remaining is recorded properly in the drug log.
- Also, make sure that you keep a running tabulation of drug use for each procedure in your lab book or surgery/testing sheets as a back-up record.
- Log any drug that is wasted/lost during use in the lab, this includes amounts left in syringes as this typically cannot be put back into your stock vial.
- Have final use and waste witnessed by another authorized agent.
- Schedule 1 and 2 drugs and records must be kept separately from schedules 3-5.
- Records should be maintained for at least two years.
- Records must be readily accessible and also must be stored securely, for this reason it is best to store them in a locked cabinet near the storage area.
- Biennial Inventory: Remaining inventories must be reported once every two years.
- Registrant must maintain a complete and accurate record of the controlled substances at the registered location and update it every two years.
- New York State record-keeping and inventory requirements dictate that records relating to the receipt of controlled substances must include the date of receipt, name and address of vendor and type and quantity of the drug received. Records of controlled substances used must include the name of the person authorized to control and use the substances, the date, type and quantity of the substances and signature of the user.
- Researchers must prepare an inventory of all controlled substances very two years. This inventory must be kept available for inspection for at least five years.
- Registrants or authorized agents may to perform weekly to monthly audits of their controlled substance inventory to accurately track inventory and avoid discrepancies.
- One authorized agent and an authorized agent witness must complete the inventory audit.
- Registrants must review records that fail to reconcile in an attempt to identify recording errors or missing transactions.
Disposal of Controlled Substances
- The Registrant should contact Environmental, Health, Safety and Risk Management, 518-276-2092 for disposal of out-of-date, damaged, or otherwise unusable or unwanted controlled substances through "Reverse Distributors"
- Schedule I and II controlled substances should be transferred via the DEA Form 222, while Schedule III–V compounds may be transferred via invoice.
- The practitioner should maintain copies of the records documenting the transfer and disposal of controlled substances for a period of two years.
- Researchers must also request the Bureau of Narcotic Enforcement approval for the on-site destruction of the controlled substances. This process requires the submission of a Request for Approval of On-Site Destruction of Controlled Substances (DOH-2340) and Controlled Substance Inventory Form (DOH-166)
Theft or Loss of Scheduled Substances
- Report theft or loss of any controlled substances immediately to Public Safety by calling their 24-hour non-emergency phone number of (518) 276-6656.
- Federal regulations require that registrants notify the DEA Field Division Office in their area, in writing, of the theft or significant loss of any controlled substance within one business day of discovery of such loss or theft.
- Registrants must also complete and submit DEA Form 106, "Report of Theft or Loss of Controlled Substances," to their local Field Division Office regarding the theft or loss. (21 C.F.R. § 1301.76(b))
- A report must still be filed if lost or stolen material is recovered. Minor discrepancies in inventory that are not attributed to theft or loss can be reconciled on the inventory report with proper notation.
- In addition to reporting theft or loss of scheduled substances to the DEA, registrants must notify the New York State Bureau of Narcotic Enforcement of any theft, loss or possible diversion of controlled substances using the Loss of Controlled Substances Report (DOH-2094) [PDF]
- Practitioner's Manual: An Informational Outline of the Controlled Substances Act, United States Department of Justice, Drug Enforcement Administration, Office of Diversion Control, 2006 Edition [PDF]
- PHL Article 33 and the Part 80 Rules and Regulations on Controlled Substances in New York State (from New York State Department of Health website)
Rensselaer Polytechnic Institute - Shipping Dangerous Goods
Interstate shipment of etiologic agents is regulated by the U.S. Department of Transportation and the Department of Health. Packaging and shipping of biological materials must be done in a way that prevents leakage and ensures the package arrives at its destination in good condition. Improper shipping of hazardous/biological/radioactive materials can jeopardize the Institute’s regulatory compliance and result in civil charges against individuals. Environmental, Health, Safety and Risk Management must be contacted at (518) 276-2092 to approve all hazardous/ biological/ radioactive materials shipments originating from Rensselaer.
The terms hazardous materials and dangerous goods are often used interchangeably when discussing shipping. Shipments of hazardous materials are regulated by several agencies, including the International Air Transport Association (IATA) for all domestic and foreign shipments by air and by the U.S. Department of Transportation (DOT) for all ground shipments. All shipments of hazardous chemicals must be prepared by trained personnel. Unless a person has completed this training, they are not allowed to ship any hazardous materials by air, ground, or sea through companies such as Fed-Ex, UPS, and DHS. Rensselaer Polytechnic Institute ships dangerous goods domestically by Fed-Ex ground. Please contact the EHS&RM at (518) 276-2092 and submit information on chemicals, biological or radiological agents to be shipped; all biological and all radioactive shipments must be coordinated with the EHS&RM.
Review and use FedEx-ex ground shipping procedure and forms are available at Fed-Ex web site; please determine if the chemicals is in the attached HAZMAT Shipping Table 16.1 before preparing your shipping package. All sections of the shipping company form (located in their online web pages) must be completed and a safety data sheet (SDS) must be attached for the material. Note that the shipping forms must be completed before the chemicals can be shipped; shipments will not be scheduled unless the contract shipper receives a fully completed shipping form and a copy of the SDS. Also please note that departments or the persons requesting this service are responsible for paying all costs associated with shipping the chemicals.
If you have any questions about this form or making chemical shipments, please contact EHS&RM by calling (518) 276-2092.