Background

To minimize risks to health, safety and security, prevent pollution and reduce generation of hazardous wastes from its facilities and mission activities the NIH has developed guidance documents, plans and polices to reduce procurement and use of specific laboratory chemicals that posed excessive risks and for which acceptable, less hazardous alternatives were available.  Some of these such as restrictions on the use and disposal of mercury were established more than 40 years ago, demonstrating NIH leadership in this area long before regulations requiring such controls were adopted. 

Of all the environmentally preferable procurement requirements, reducing purchasing and potential exposure to toxic chemicals most clearly relates to and supports our primary missions of disease prevention and human health promotion. Yet guidance for reducing procurement of toxic products is scant and there are daunting obstacles that must be overcome before measures to reduce procurement and use of hazardous and environmentally damaging substances can be designed and broadly implemented:

DEP’s initial steps in implementing this SoC reduction program was to create an Interim List of SoCs, general guidance on reduction strategies for listed substances and procurement restrictions for the small number products containing SoCs that have well defined, lower risk alternatives

This is a work in progress and we anticipate the need for corrections and frequent updates.  We invite comments from both purchasers and suppliers, and encourage participation in developing and implementing this initiative by NEMS Green Teams, our scientific community and procurement officials.

Regulatory Framework and Authorities

This initiative is authorized by and responsive to multiple mandates applicable to federal agencies for preventing pollution, reducing procurement of hazardous substances and minimizing generation of wastes.

Federal Statutes.  A large array of statutes, regulations, Executive Orders, HHS and NIH policies and plans regulate the use and disposal of hazardous and polluting chemicals.  Until recently, fewer mandates governed procurement of these substances.  Among these was the Resource Conservation and Recovery Act of 1976 (RCRA), which set an objective requiring minimization of hazardous wastes by several methods including process substitution.  In 1984, the Hazardous and Solid Waste Amendments (HSWA) to RCRA focused more on minimization and required generators to certify that they had a program in place to reduce the volume, quantity and toxicity of the wastes they generated.  In 1990, passage of the Pollution Prevention Act expanded the nation's waste prevention policy beyond a RCRA-only framework to minimizing or eliminating toxic releases to all environmental media and natural resources.  It also set a national policy that waste should be prevented or reduced at its source whenever feasible.  Reducing or eliminating waste by avoiding or reducing procurement of products and services that emit pollutants or generate hazardous wastes is an effective best practice for source reduction and meets the intent of these laws.

Executive Orders.  Successive presidential Executive Orders over the last several years have also been issued requiring federal agencies to reduce wastes and emissions by implementing pollution prevention measures.  Section 2(e) of Executive Order 13423 of January 24, 2007, titled Strengthening Federal Environmental, Energy, and Transportation Management set toxic chemical and hazardous substance release and use reduction goals and required more widespread use of Environmental Management Systems (EMS) as the framework in which to manage and continually improve these sustainability practices.

Executive Order 13514 of October 2009 titled Federal Agency Leadership in Environmental, Energy, and Economic Performance required sustainable practices, toxic and hazardous chemical reductions, and ‘green’ federal agency procurement. 

EO 13693, titled Planning for Federal Sustainability in the Next Decade, issued in March 2015; was the most recent environmental order affecting federal agency procurement.  Among its many provisions were new requirements that are authorized and will implemented by this initiative:

• Reduction and minimization of the quantity of toxic and hazardous chemicals and materials acquired, used, or disposed of;

• Increasing agency use of acceptable alternative chemicals and processes in keeping with the agency’s procurement policies; and decreasing agency use of chemicals where such decrease will assist the agency in achieving greenhouse gas emission reduction targets;

• Chemical inventory reporting in accordance with the requirements of sections 301 through 313 of the Emergency Planning and Community Right-to-Know Act of 1986 (42 U.S.C. 11001 et seq.); and

• Requirements that all new contract actions, including task and delivery orders meet sustainable acquisition requirements, including non-toxic or less toxic alternatives where such products and services meet agency performance requirements.

Federal Acquisition Regulation Implementing E.O. 13514.  On May 31, 2011 DoD, GSA, and NASA issued an Interim Rule amending the Federal Acquisition Regulation (FAR) to implement Executive Order 13514 including requirements for acquisition of non-toxic products or less toxic alternatives, and contractor compliance with agency Environmental Management Systems.

HHS Policies and Plans.  Several Department of Health and Human Services (HHS) and NIH plans and policies set requirements, goals and have provided guidance on reducing procurement of products containing chemicals referred to here as Substances of Concern.  Examples include the HHS Sustainable Building Implementation Plan of December, Affirmative Procurement Plan, and the HHS Strategic Sustainability Performance Plan.

State and Local Regulations.  Many states and local governments have promulgated regulations restricting or prohibiting the sale or purchasing of specific substances and products containing them to control or prevent pollution.   Under the provisions of E.O. 12088 and the Federal Facilities Compliance Act of 1992 federal purchasers located in these jurisdictions may be subject to these regulations, particularly if they were adopted to control hazardous or solid waste.

NIH Delegation of Authority.   Under the NIH Director’s Delegation of Authority 19, the Associate Director for Research Facilities Development and Operations (ORF) administers, interprets and oversees the applicable environmental laws, Executive Orders and regulations for the NIH.  The Division of Environmental Protection (DEP) is a division of the ORF.  The NIH Policy Manual 3032 also gives the Division overall responsibility for waste management activities at NIH facilities including assisting the NIH Institutes and Centers (ICs) in meeting requirements for affirmative procurement of products and services that maximize environmental performance and minimize generation of wastes.

Criteria for Listing Substances of Concern

Groups of chemicals and specific substances had to meet all of the following three criteria to be listed as Substances of Concern:

• 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.

• Pose Significant Risk. The substance must pose a known hazard or risk in the supply chain, as used at NIH or after use.  These include hazards or risks to

• Human Health

• Safety

• Security

• Environment

• Research Mission

• Compliance

• Sustainability

• 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

DEP identified and established a list of 21 Functional Use Categories to include approximately 132 SoCs based upon the most current scientific data and rapidly evolving regulatory requirements.  

The 21 Functional Use Categories include the following (Add link to each FUC below):

• Antimicrobials/Disinfectants/Preservatives - Aldehydes

• Antimicrobials/Disinfectants/Preservatives - Organotin Compounds

• Antimicrobials/Disinfectants/Preservatives – Phenolic Compounds

• Antimicrobials/Disinfectants/Preservatives – Quaternary Ammonium Compounds (Quats)

• Bisphenols

• Brominated Flame Retardants (BFR)

• Ethidium bromide

• Ethylene Oxide

• Heavy Metals – Arsenic

• Heavy Metals – Cadmium

• Heavy Metals – Hexavalent Chromium

• Heavy Metals – Mercury and Mercury Compounds (metallic)

• High Volume Solvents – Alcohols, Alkanes, Nitriles, and Amides

• High Volume Solvents – Aromatic Solvents

• High Volume Solvents – Halogenated Solvents

• Inorganic Acids

• Isocyanates

• Perfluorinated Compounds (Coatings and Plastics)

• Organic Acids

• Strong Acids

• Surfactants (Alkylphenols)

Each Functional Use Category lists:

• Individual SoCs (total of 132) with Corresponding CAS RN and Synonyms

• General Description

• General Uses and Product Application

• Primary Health Concerns

• NIH Use-Specific Alternatives and Reductions Strategies

DEP is working on 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 program 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.

In developing this database, 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.

Contact Information

Questions, comments, recommendations concerning the Substances of Concern Reduction Initiative are welcome.  Please submit these to the Environmental Protection Division at 301-496-7990 or email to green@mail.nih.gov.​

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