Responsible Official: Chief Procurement Officer
Responsible Office: Procurement
Effective Date: September 15, 1999
Revision Date: April 30, 2025
Policy Sections
3220.3 Controlled Substances in Research
3220.5 Safety-Critical Equipment
3220.7 Non-Taxable Ethyl Alcohol
3220.8 Covered Telecommunications Equipment or Services
Scope
This policy defines restricted items and the guidelines that must be followed for such purchases.
Policy Statement
In the course of their work, University employees, staff, and students routinely use a variety of potentially hazardous materials, safety-critical equipment, radioactive materials, vertebrate animals, and controlled substances in research. The University permits these uses, but only with oversight to ensure safety and compliance with relevant restrictions and regulatory requirements. In addition, federal law and University policy place limits on the University’s use of certain types of telecommunications technologies and services. Therefore, the purchase of these items is subject to special rules, in addition to the rules governing University procurement as defined in Policy 3201 General Purchasing. University personnel are responsible for following the requirements defined by this policy.
Due to their critical and/or regulated nature, restricted items may only be ordered via Yale’s procurement system and only if all necessary approvals have been obtained. University purchasing cards, personal credit cards, checks, cash or standing orders may not be used to order any of these items.
Reason for the Policy
This policy is intended to ensure that individuals and departments needing restricted items at the University have the capability to acquire them in compliance with applicable University, state, and federal requirements.
Definitions
Items subject to special safety or other regulatory requirements, whose purchase and handling are subject to special procedures are outlined below. For the purpose of this policy, restricted items include certain highly hazardous materials, safety-critical equipment, radioactive materials, vertebrate animals, controlled substances (i.e., scheduled drugs and certain drug precursors), regulated technologies and services, and non-taxable ethyl alcohol and select agents, as defined below.
Animals
Any live, vertebrate animal used or intended for use in research, research training, experimentation, biological testing or for related purposes. Examples include, but are not limited to, traditional laboratory animals, farm animals, wildlife, birds and aquatic species.
Biological Materials
Biohazardous or regulated biological materials include, but are not limited to, human, animal and plant pathogens, low LD50 toxins of biological origin, pathogen based plasmids and vectors for research involving recombinant or synthetic nucleic acid molecules. There are also very highly regulated research materials such as government-regulated select agents and agents listed by the United States Government as Dual Use Research of Concern agents. By extension, Biological materials may also encompass equipment and devices associated with biocontainment or high risk biohazardous research. Examples include clean air devices, such as biosafety cabinets, clean benches, high-speed cell sorters, autoclaves, sterilizers, powered-air-purifying respirators, HEPA filters. Biohazards may also be associated with research animals that may be handled in the field or purchased for research. Livestock animals such as sheep, goats, horses or cattle, bats, birds, dogs, and non-human primates may also require review for the potential introduction of zoonotic agents to Yale. Purchase of these animals must be approved by the Yale Institutional Animal Care & Use Committee (“IACUC”) and Yale Animal Resources Center (“YARC”), but it also requires review and approval from Environmental Health & Safety (“EHS”).
Chemicals
Chemicals that present unusual acute or long-term chronic health hazards such as carcinogens, reproductive toxins, and toxic pressurized gases. Chemicals that present strong physical hazards such as explosives and pyrophoric compounds are also included in this category.
Controlled Substances in Research
Controlled substances covered by this policy are substances used in research that are listed by the U.S. Department of Justice, Drug Enforcement Administration (“DEA”) and/or the Connecticut Department of Consumer Protection, Drug Control Division (i.e., scheduled drugs and certain drug precursors).
Covered Telecommunications Equipment or Services
Covered Telecommunications Equipment or Services include telecommunications or video surveillance equipment produced or provided by Huawei Technologies Company, ZTE Corporation, Hytera Communications Corporation, Hangzhou Hikivision Digital Technology Company, or Dahua Technology Company, or any subsidiary or affiliate of such entities.
Laser (3B/4)
The University permits the procurement, use, and storage of class 3B and 4 lasers for basic science, research, and educational purposes. Purchase and use are subject to oversight by the Laser Safety Committee, a subgroup of the Radiation Safety Committee (“RSC”).
Non-Taxable Ethyl Alcohol
Non-taxable high-proof ethyl alcohol is regulated by the federal Bureau of Alcohol, Tobacco, and Firearms.
Radioactive Materials
By-product, source, special nuclear, accelerator produced, generally licensed, or naturally occurring materials (“RAM”). Radionuclides may emit alpha, beta, gamma, or Xrays, neutrons or other emissions. Examples of common radioisotopes include, but are not limited to, P-32, P-33, S-35, C-14, H-3, and I-125, including sources sold by suppliers as “exempt”.
Safety-Critical Equipment
Equipment that can present safety hazards to users (e.g., X-ray devices, lasers, and Magnetic Resonance equipment MRI or NMRs) as well as equipment used to control exposures to recognized hazards, and which improper use could subject users to harm (e.g., fume hood).
X-ray Producing Devices
The University’s registration with the CT DEEP permits the procurement, use, storage of x-ray producing devices for basic science, research, and educational purposes. Purchase and use are subject to the Yale University RSC.
Policy Sections
University employees, staff, and students routinely use a variety of potentially hazardous materials in their work. Safe management of these materials is promoted through training and education programs and periodic safety inspections. A small subset of these materials requires greater scrutiny for regulatory and safety purposes. To ensure that oversight is consistently provided without unreasonably interfering with operations and research, the University requires all individuals and departments with a legitimate need to purchase restricted items to do so in accordance with this policy.
If a purchase request is denied, the decision may be appealed through the University Safety Committee, Radiation Safety Committee, Biological Safety Committee, Laboratory Safety Committee, the Yale IACUC, or the Office of General Counsel (“OGC”), as appropriate.
3220.1 Biological Materials
Research with biohazards and regulated biological materials must be registered with the laboratory’s site-specific risk assessment and containment measures. Such research may only be authorized by the relevant Committee or entity associated with approving such work. These measures have been implemented to ensure that these materials are handled safely and also in conformity with applicable local, state and federal regulations, standards and guidelines. Please consult with the list of regulated biological materials:
- Select Agents and Toxins: Federal Select Agent Program: Select Agents and Toxins List
- Dual Use Research of Concern Agents: Pages 63 – 64 of the Dual Use Research of Concern Implementation Guide for a complete list of DURC agents: https://aspr.hhs.gov/S3/Documents/USG-DURC-PEPP-Implementation-Guidance-May2024-508.pdf
- Risk Group 2 and 3 human pathogens (Risk Group 4 research is not permitted at Yale): Page 39 – 46 of the NIH Guidelines (Appendix B): https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.pdf
- USDA regulated animal pathogens: https://www.aphis.usda.gov/animal-product-import/organisms-vectors/livestock-poultry-pathogens
- USDA APHIS PPQ regulated plant pathogens: https://www.aphis.usda.gov/plant-imports/regulated-pest-list
- Toxins with an LD50 of < 100 ug/kg: https://ehs.yale.edu/sites/default/files/files/biosafety-manual.pdf
- Pathogen based plasmids or vectors used in research involving the use of recombinant or synthetic nucleic acid molecules (examples include, Lentiviral, retroviral, adenoviral, adeno associated viral, herpesvirus, vesicular stomatitis virus, and Sindbis virus vectors).
3220.2 Chemicals
Items considered hazardous chemicals under this section can pose serious risks of injury or physical damage and require authorization for use prior to acquisition. They may only be ordered and used by groups whose facility, safety equipment, and training so prepare them. Purchases of these items must be made through the Yale procurement system to facilitate order tracking and approval. Examples of chemicals requiring purchase approval include: highly reactive/pyrophoric compounds, toxic compressed gases, highly toxic chemicals, and DHS-regulated chemicals. As these lists periodically change, please consult the following link for the most current information:
3220.3 Controlled Substances in Research
Due to their potential for misuse and abuse, items listed by the DEA and/or the Connecticut Department of Consumer Protection, Drug Control Division (“DCD”), as Schedule I to V drugs are subject to special procurement, storage, use, and disposal requirements. These include federal and state licensing (prior to procurement), maintaining detailed storage and use records, and special disposal procedures.
Since the University cannot, by law, maintain a “blanket” registration for controlled substances, it is the responsibility of individual researchers and other staff using these materials to obtain appropriate registrations and licenses. EHS facilitates the processing of state/federal controlled substance licensing/registrations for individual Yale researchers. Requests for new or renewal registrations and licenses must be submitted to EHS for processing.
EHS Integrator Controlled Substance Application: EHS Integrator Controlled Substance Registration
Purchases of controlled substances for research use must be made via Yale’s procurement system.
3220.4 Radioactive Materials
The University permits the procurement, use, storage and disposal of radioactive materials and radioactive sources for basic science and biomedical research, testing, calibration and educational purposes. Purchase and use are subject to oversight by the RSC. RSC policies require that only authorized and trained persons may acquire radioactive materials, radioactive sources and x-ray generating equipment. All receipts of such materials or items must be coordinated through the Radiation Safety Section (“RSS”) of Environmental Health and Safety. Additional information regarding the requirements and process of acquiring RAM can be found at Purchasing Radioactive Material.
Further, some radioactive materials and sources may be subject to incoming survey and security requirements and thus are only delivered to designated receiving locations. After an incoming package survey, delivery of the RAM to authorized laboratories is arranged through the RSS.
Purchases of radioactive materials must be made via Yale’s procurement system.
3220.5 Safety-Critical Equipment
Purchases of items considered safety-critical equipment under this section must be made via Yale’s procurement system and with EHS approval. EHS review and approval is part of the procurement system’s routing process.
Lasers class 3B and 4 and x-ray generating equipment follow different approval processes, as described in sections Lasers (3B/4) and X-ray Producing Devices below.
Many of the safety-critical equipment items require ongoing maintenance, testing, specialized training, and certification. It is the responsibility of the owner department to ensure that these requirements are fulfilled. Safety critical equipment requiring EHS approval is listed below:
| Safety Critical Equipment Requiring Pre-Order Review/Approval | ||
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Lasers (3B/4)
Purchase and use of class 3B and 4 lasers are subject to oversight by the Laser Safety Committee, a subgroup of the RSC. RSC policies require that only authorized and trained persons may acquire class 3B and 4 lasers and laser systems. All receipts of such items must be coordinated and/or communicated through the RSS of Environmental Health and Safety.
Various enclosed laser systems, such as laser cutters, confocal microscopes, and Raman microscopes may be listed as Class 1 systems; however, receipt of these items must be communicated through the RSS of Environmental Health and Safety due to the Class 4 lasers embedded/enclosed within the devices.
Further, class 3B and 4 lasers, or systems containing class 3B or 4 lasers, may be required to have EHS perform an initial safety survey at installation, before the system is operational. All class 3B and 4 lasers will need a safety survey on a routine basis thereafter.
Additional information regarding the requirements and process of acquiring these items can be found at: EHS Lasers. Questions regarding receipt of class 3B or 4 lasers can be directed to lasersafety@yale.edu.
X-ray Producing Devices
Further, x-ray producing devices will be subject to an initial safety survey at installation prior to the system being operational. All x-ray producing equipment will require a safety survey on an annual basis thereafter.
Additional information regarding the requirements and process of acquiring these items can be found at: EHS X-rays.
3220.6 Animals
The University permits the use of vertebrate animals in animal-related research, testing or training, but the purchase and use of animals is subject to approval and oversight under rules defined by the Yale Institutional Animal Care and Use Committee (“IACUC”) and the director of the Yale Animal Resources Center (“YARC”). These rules require that the YARC Procurement Office process any order for vertebrate animals to be received on or off the Yale campus or used in University activities. All requisitions require a valid protocol number from IACUC. Requests for the purchase of animals must be placed through eSirius via the YARC Website.
Note: Livestock animals such as sheep, goats, horses or cattle, bats, birds, dogs, and non-human primates may also require review by EHS for the potential introduction of zoonotic agents to Yale.
3220.7 Non-Taxable Ethyl Alcohol
The University must maintain records, and report all purchases of non-taxable, high-proof ethyl alcohol. The Department of Transport, Receiving, and Storage (“TR&S”) maintains a supply of this alcohol for research use and keeps records of use and reorder. To request alcohol from this stock, University users and departmental stockrooms must complete a Stock Request Form.
3220.8 Covered Telecommunications Equipment or Services
Federal law places limits on the use of certain telecommunications equipment or services produced or provided by Huawei Technologies Company, ZTE Corporation, Hytera Communications Corporation, Hangzhou Hikvision Digital Technology Company, Dahua Technology Company, and any subsidiary or affiliate of these entities. Such Covered Telecommunications Equipment or Services may not be purchased without advance approval from Export Controls. The use of Covered Telecommunications Equipment or Services for University business is generally prohibited under Policy 1607 Information Technology Appropriate Use Policy.
Special Situations/Exceptions
The policies governing the purchase of restricted materials are designed to meet regulatory compliance requirements and ensure the health and safety of the University community. Requests for exceptions, variances, or modifications to these policies should be directed, in writing, to the Procurement Department and Yale Environmental Health and Safety, the Yale Institutional Animal Care and Use Committee, or Exports Controls, as appropriate. Any appeals to the decisions should be brought to the attention of the appropriate University committee or the Office of General Counsel (as listed in Policy Section above). Questions regarding interpretation of this policy should be forwarded to the Procurement Department.
Roles and Responsibilities
Export Controls
- Maintains list of entities whose products and services are subject to regulation as Covered Telecommunications Technologies or Services.
- Reviews requests to purchase Covered Telecommunications Equipment or Services.
Environmental Health and Safety
- Establishes procurement and handling guidelines regarding hazardous materials, safety-critical equipment, radioactive materials, and use of controlled substances in research laboratories at the University.
Procurement Department
- Reviews and approves purchases of restricted items via Yale’s procurement system from authorized University personnel or departments in accordance with the guidelines and restrictions discussed in this policy.
Requisitioner
- Prepares and submits required documents and obtains approvals necessary for compliance.
Transport, Receiving and Storage (“TR&S”)
- Maintains stocks of non-taxable ethyl alcohol and records of their use at the University.
Yale Animal Resources Center
- Oversees the purchase, handling, husbandry, and health care of vertebrate animals used in research, testing, or training at the University.
Related Resources
3220 FR.02 Application for Controlled Substance Laboratory License - State of CT
3220 FR.04 COA Approval for State DCD Controlled Substance License
1607 Information Technology Appropriate Use Policy