3220 Purchase of Restricted Items

Responsible Official: 
Chief Procurement Officer
Responsible Office: 
Procurement
Effective Date: 
September 15, 1999
Revision Date: 
July 1, 2017

* This policy has been updated to accommodate Workday Financials business processes and terminology.  Please note the effective revision date.

  • Note: Guidelines for Restricted Items Requiring Pre-Order Approval are posted to Yale Environmental Health and Safety

Policy Sections

3220.1 Hazardous Materials

3220.2 Safety-Critical Equipment

3220.3 Radioactive Materials

3220.4 Animals

3220.5 Controlled Substances in Research

3220.6 Non-Taxable Ethyl Alcohol

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 to the rules governing University procurement as defined in Policy 3201 General Purchasing Policy, the purchase of these items therefore involves special rules.  University personnel are responsible for following the appropriate procedures defined by this policy.

Due to their critical nature, restricted items may only be ordered via Yale’s e-procurement solution or the Purchasing Department.  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), 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.

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).

Hazardous Materials
Materials that present special safety risks during transport, storage, use, or disposal.  These include, but are not limited to, certain highly toxic, reactive, or otherwise hazardous chemicals, gases, and biological agents.

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 material whose purchase and use is licensed by the US Nuclear Regulatory Commission (NRC) and/or the CT Department of Energy and Environmental Protection (DEEP).  These radionuclides may emit alpha, beta, gamma, or Xrays, neutrons or other emissions.  Examples of 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 and laser equipment) as well as equipment used to control exposures to recognized hazards, and whose improper use could subject users to harm (e.g., fume hood).

Yale’s E-Procurement Solution
The Workday Create Requisition function replaces SciQuest as Yale’s e-procurement solution as of July 1, 2017.  SciQuest catalogs and contract pricing are available via the Connect to Supplier Website option.

Yale’s Expense Management Solution
Yale’s expense management solution includes the processing, creation, and submission of expense reports for the following expenditures: travel and business related expenses and miscellaneous small dollar purchases incurred on a University PCard or with personal funds (cash out-of-pocket (OOP)).  The expense management solution supports the requesting and clearing of cash advances for travel and expenses as well as study subject advances.

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 these procurement procedures.

If a purchase request is denied, the decision may be appealed through the University Safety Committee, Radiation Safety Committee, Biological Safety Committee, Chemical and Laboratory Safety Committee, or the Yale Institutional Animal Care and Use Committee (IACUC) as appropriate.

Items considered hazardous materials under this section can pose serious risks of injury or exposure, or require authorization for use prior to acquisition, and therefore 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 e-procurement solution, to facilitate order tracking and approval.  Examples of hazardous materials requiring pre-order approval include: highly reactive/pyrophoric compounds, toxic compressed gases, highly toxic chemicals, DHS-regulated chemicals, select agents as defined by CDC/USDA, other human pathogens, defective pathogen vectors and vector kits used for research experiments involving recombinant and synthetic nucleic acid molecules, and other high hazard compounds.  As these lists periodically change, please consult the following links for the most current information:

Restricted Chemicals – http://ehs.yale.edu/forms-tools/chemicals-requiring-ehs-pre-approval

Select Agents – http://www.selectagents.gov/SelectAgentsandToxinsList.html  

Purchases of items considered safety-critical equipment under this section must be made via Yale’s e-procurement solution or with Environmental Health and Safety (EHS) approval. Many of these 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 pre-order approval are listed below:

Safety Critical Equipment Requiring Pre-Order Review/Approval

Autoclaves

Automated external defribrillation (AED) devices

Automated film processors

Biological safety cabinets

Clean benches (horizontal or vertical laminar flow)

Compressed Gas lecture bottles

Compressed Gas manifold delivery systems

Cranes and hoists

Drones a.k.a Unmanned Air Vehicles/Systems

(UAV/UAS), copters, planes, radio controlled  aircrafts

Electron microscopes

Emergency eye washes and safety showers

Ethylene oxide sterilizers

Forklifts and related motorized equipment

Fume hoods

Gamma counters (or gamma detectors)

Glove boxes

High speed cell sorters

High strength magnetic field equipment

Lasers - Class 3B/4

Lead bricks, aprons or other lead shielding

Liquid scintillation counters (LSC)

Respirators and replacement cartridges and filters

Tools greater than ½ hp (horsepower):

Tools Classification Matrix

Tritium 3H exit signs

X-ray generating equipment

The University’s US NRC licenses and CT DEEP registrations permit the procurement, use, storage and disposal of radioactive materials (RAM) and radioactive sources for basic science and biomedical research, testing, calibration and educational purposes.  Purchase and use are subject to oversight by the Yale University Radiation Safety Committee (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.  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 e-procurement solution.

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 the eSirius homepage.  If you do not have access to eSirius, access can be requested via http://medicine.yale.edu/yarc/forms/esiriusaccess.aspx.

Due to their potential for misuse and abuse, items listed by the US Department of Justice, Drug Enforcement Administration (DEA) and/or the Connecticut Department of Consumer Protection, Drug Control Division (DCD), as Schedule I to IV 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.

Purchases of controlled substances for research use must be made via Yale’s e-procurement solution.

The University must maintain records, and report all purchases of non-taxable, high-proof ethyl alcohol.  Contract orders for non-taxable ethyl alcohol are managed by the Purchasing Services Department.  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 Requisition form.

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 Purchasing Services Department and Yale Environmental Health and Safety or the Yale Institutional Animal Care and Use Committee, as appropriate.  Any appeals to the decisions should be brought to the attention of the appropriate University committee (as listed in Policy Section above).  Questions regarding interpretation of this policy should be forwarded to the director of Purchasing Services. 

Roles and Responsibilities

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.

Transport, Receiving and Storage (TR&S)
Maintains stocks of non-taxable ethyl alcohol and records of their use at the University.

Requisitioner
Prepares and submits required documents and obtains approvals necessary for compliance.

Purchasing Services Department
Purchases restricted items on requisitions from authorized University personnel or departments in accordance with the guidelines and restrictions discussed in this policy.  Establishes contract orders with suppliers for the purchase of non-taxable ethyl alcohol.

Yale Animal Resources Center
Oversees the purchase, handling, husbandry, and health care of vertebrate animals used in research, testing, or training at the University.