Criteria for Listing Substances of Concern
Groups of chemicals and specific substances must meet all of the following three criteria to be listed as Substances of Concern:
1. Have Significant Use in Facilities or Mission Activities. The substance must have a significant known or potential use or emission from products used in NIH facilities or mission activities. Over 100,000 discrete substances are used or maintained in NIH research repositories. Most of these are in very small quantities, present minimal potential for exposure and release, do not justify development of procurement controls and will not be listed as SoCs. Exceptions may be made for extremely hazardous substances that present unacceptable risks even in small quantities.
2. Pose Significant Risk. The substance must pose a known hazard or risk in the supply chain, as used at the NIH or after use:
a. Human Health. Substances that can result in sufficient levels of human exposure and intake as evidenced by biomonitoring or other data, to cause potential adverse health impacts. These include but are not limited to asthmagens, allergens, carcinogens, endocrine disruptors, teratogens and substances causing other types of acute or chronic toxicity to humans.
b. Safety. Substances with other hazardous properties such as flammability, corrosivity or reactivity.
c. Security. Substances that are potentially explosive, extremely toxic or particularly subject to abuse or diversion for malicious use, or require special compliance with specific security requirements or precautions.
d. Environment. Substances that are bioaccumulative, persistent or have other adverse impacts when released into the external environment. Examples of such impacts include upsetting waste or wastewater treatment processes, toxicity to wildlife, reducing biodiversity and ecosystem services, increasing global warming, depleting stratospheric ozone, generating air pollutants, or preventing NIH from meeting goals established by its Environmental Management System.
e. Research Mission. Substances with a potential to contaminate or interfere with research activities or results; affect laboratory animals, or are likely to be present as contaminants in facilities undergoing decommissioning and require remediation before beneficial reuse or demolition.
f. Regulatory Compliance. Substances that may be banned, restricted, require special inventory controls, security precautions; are subject to regulation at very low concentrations; are associated with unusually high potential liability, or are likely to be regulated as hazardous waste when disposed of.
g. Sustainability. Substances that require excessive amounts of energy or water or deplete scarce resources to produce or that make the final product less reusable, recyclable, recoverable or suitable for regeneration; or impede meeting other NIH sustainability and environmental justice goals.
3. Suitable Alternatives are Available. Alternative products or services that do not contain or emit the substance(s) of concern, and pose a lower risk(s) must be developed, suitable and approved for the specific intended use and available at reasonable cost. Substances in critical uses that do not meet this criterion will be listed as SoCs but may not be amenable to reduction by procurement controls.
Development of Substance of Concern Listings and Controls
Development of a comprehensive program to identify and reduce procurement of products and services containing or emitting Substances of Concern will be a long term effort requiring additional resources, large supporting databases and extensive collaboration among multiple agencies and the suppliers of goods and services in the private sector. Major elements of this innovative program have been proposed by DEP but are not yet in place. These will include development and operation of efficient NEMS processes for:
· Establishing and maintaining the SoC listings based upon the most current scientific data and rapidly evolving regulatory requirements.
· Collecting and maintaining accurate, standardized data on the presence or release of SoCs from specific uses of the myriad products and services purchased by NIH.
· Accessing the comparative toxicology of products and alternatives in defined, specific uses.
· Integrating and weighting restrictions on SoCs with other sustainable acquisition criteria in making purchasing decisions.
· Maintaining required SoC inventories and tracking compliance with SoC restrictions using online purchasing systems.
· Training purchasers on SoC reduction requirements.
· Open and transparent communication of SoC listing actions, reduction guidance, requirements and specifications to suppliers and the public.
Until this program can be fully implemented the DEP has established an Interim Listing of Substances of Concern and is developing methods to identify and track purchases of services and products containing these SoCs using the NIH Purchasing Online Tracking System (POTS). The purposes of this listing are to:
· Improve awareness by purchasers and suppliers of SoCs, alternatives in commonly products and services, and requirements to reduce procurement of SoCs.
· Comply with requirements of regulations and Executive Orders
· Serve as the official source of NIH Environmental Management System (NEMS) requirements relating to procurement and use of Substances of Concern by contractors and suppliers to NIH. This was authorized by the above referenced Federal Acquisition Regulation (FAR) Interim Rule of May 31, 2011 that requires contractor compliance with the procuring agency’s EMS.
To develop this list DEP has used numerous references and databases. These include the National Library of Medicine’s Hazardous Substance Data Base (HSDB) and Household Products Database; previous lists from the NIH Pollution Prevention Plan and NIH chemical reduction plans; lists developed by regulatory agencies, e.g., EPA and OSHA for similar purposes; CDC biomonitoring data; the National Toxicology Program (NTP) reports on Carcinogens; hazardous waste generation reports from NIH facilities; and information on chemicals used in common building materials and other commodities likely to be used in NIH facilities that are not likely to be disposed of as hazardous waste or included in related reports.