public health security and bioterrorism preparedness and response act, select agents, terrorism, terrorist, nih guidelines for research involving recombinant or synthetic nucleic acid molecules, U.S. institutions, foreign organizations and international organizations, U.S. institutions with foreign subcomponents, dual use research of concern, DURC, agents regulated under the chemical weapons convention, CWC
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, 42 U.S.C. 201, is designed to provide protection against misuse of select agents and toxins whether inadvertent or the result of terrorist acts against the U.S. homeland or other criminal acts. The Act was implemented, in part, through regulations published by HHS and USDA at 42 CFR 73, 9 CFR 121 and 7 CFR 331 or commonly referred to as "Select Agent Regulations." Copies of these regulations are available at https://www.selectagents.gov/regulations/index.htm, or can be obtained from CDC, 1600 Clifton Road, MS A-46, Atlanta, GA 30333; telephone: 404-718-2000.
Research involving select agents and recombinant or synthetic nucleic acid molecules also is subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). The NIH Guidelines apply to all research projects (NIH-funded and non-NIH-funded) that involve recombinant or synthetic nucleic acid molecules and are conducted at or sponsored by an organization that receives NIH support for recombinant or synthetic nucleic acid molecule research. A copy of the NIH Guidelines are available at https://osp.od.nih.gov/biotechnology/nih-guidelines/.
Domestic recipients who conduct research involving select agents or toxins (see Section 3 and 4 of 42 CFR 73 and 9 CFR 121 and Section 3 of 7 CFR 331) must maintain a registration with CDC (or USDA, depending on the agent) before using NIH funds. No funds can be used for research involving select agents or toxins if the registration certificate maintained by CDC or USDA is suspended or revoked.
Foreign Organizations and International Organizations who conduct research involving select agents (see 42 CFR 73 for the select agent list; and 7 CFR 331 and 9 CFR 121 for the relevant animal and plant pathogens) must provide information satisfactory to the NIH that a process equivalent to that described in 42 CFR 73 for U.S. institutions is in place and will be administered on behalf of all select agent work sponsored by NIH funds before using these funds for any work directly involving select agents. Recipients must be willing to address the following key elements appropriate for their institutions: safety, security, training, procedures for ensuring that only approved/appropriate individuals have access to the select agents, and any applicable laws, regulations and policies equivalent to 42 CFR 73. If this work will not, in fact, involve select agents (e.g. excluded strains), and you provide documentation satisfactory to the NIH that your work does not now nor will it in the future (i.e. throughout the life of the award) involve select agents, no further action will be necessary.
Recipients who conduct research involving select agents (see 42 CFR 73 for the select agent list; and 7 CFR 331 and 9 CFR 121 for the relevant animal and plant pathogens) must complete registration with CDC (or USDA, depending on the agent) before using NIH funds for any work directly involving the select agent at the U.S. institution. No funds can be used for research involving select agents if the final registration certificate is denied. Before using NIH funds for any work directly involving the select agents at a foreign subrecipient, the U.S. recipient must provide information from the foreign organization satisfactory to the NIH that a process equivalent to that described in 42 CFR 73 for U.S. institutions is in place and will be administered on behalf of all select agent work sponsored by these funds. Recipients must be willing to address the following key elements appropriate for the foreign organization: safety, security, training, procedures for ensuring that only approved/appropriate individuals have access to the select agents, and any applicable laws, regulations and policies equivalent to 42 CFR 73 are followed. If this work will not, in fact, involve select agents (e.g. excluded strains), and you provide documentation satisfactory to the NIH that your work does not now nor will it in the future (i.e. throughout the life of the award) involve select agents, no further action will be necessary.
On September 24, 2014, the Federal government issued a policy for the oversight of life sciences "Dual Use Research of Concern" (DURC). This policy applies to all New and Renewal awards issued on applications submitted on or after January 25, 2015, and to all non-competing continuation awards issued on or after January 25, 2015. Institutions must then implement the Policy by September 24, 2015. DURC is defined as life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security. Despite its value and benefits, some research may be misused for harmful purposes. The fundamental aim of this oversight policy is to preserve the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research.
The DURC policy applies to recipients in the United States that receive Federal funding for life sciences research and that conduct or sponsor research involving one or more of the 15 agents or toxins listed in the policy and to foreign recipients that receive Federal funding to conduct or sponsor research involving one of these 15 agents or toxins. Institutions must establish an Institutional Review Entity (IRE) which must review research involving these agents or toxins to determine if it involves one or more of the listed experimental effects and if so, whether it meets the definition of DURC. Recipients also must establish an Institutional Contact for Dual Use Research (ICDUR), as required by the U.S. Government's DURC Policy, and explain the ICDUR's role. The award recipient must maintain records of institutional DURC reviews and completed risk mitigation plans for the term of the research grant or contract plus three years after its completion, but no less than eight years, unless a shorter period is required by law or regulation.
For research that may be considered DURC, NIH will work collaboratively with the institution and investigators to develop a risk mitigation plan, which may be implemented through a term of award and that the NIH must approve. For example, NIH may request that institutions periodically review a project for its DURC potential, propose any modifications to the risk mitigation plan, and share any resulting manuscripts with their Program Official prior to submitting the manuscript to a journal.
The United States is one of 175 States Parties to the Chemical Weapons Convention (CWC), which prohibits the development, production, stockpiling, and use of chemical weapons (CW). The CWC does not prohibit production, processing, consumption, or trade of related chemicals for peaceful purposes, but it does establish a verification regime to ensure such activities are consistent with the object and purpose of the treaty.
NIH researchers engaged in activities involving these chemicals, especially Schedule 1 chemicals, may be required to submit declarations and/or reports to the Bureau of Industry and Security (BIS) and may be subject to inspection by the Organization for the Prohibition of Chemical Weapons, which administers the CWC. In addition, trade in certain chemicals with States not Party to the CWC may be prohibited or subject to an export license and or end-use certificate.
Schedule 1 chemicals include, but are not limited to, the toxic chemicals sarin, soman, tabun, VX, sulfur mustards, Lewisites, saxitoxin, ricin, and nitrogen mustards. More information about the U.S. CWC, including complete lists of Schedule 1, 2, and 3 chemicals under the CWC may be found at http://www.cwc.gov/index.html. Federal regulations that apply to the CWC are 15 CFR CHAPTER VII, SUBCHAPTER B, PARTS 710-722, SUBCHAPTER C, PARTS 730-774; 22 CFR CHAPTER I, PART 103, PARTS 120-130. These CRFs and other applicable safety standards issued by the Department of Commerce and Department of State are available at http://www.cwc.gov/regulations_cwc_regulations.html.