United States of America: Perspectives and Approaches to Biosafety and Biosecurity Regulatory Framework Samuel S. Edwin, PhD Director, Division of Select Agents and Toxins September 26-28, 2018 Centers for Disease Control and Prevention Office of Public Health Preparedness and Response Federal Select Agent Program (FSAP) FSAP regulates the possession, use, and transfer of biological select agents and toxins that have the potential to pose a severe threat to public, animal or plant health, or to animal or plant products Managed jointly by: ▪ The Division of Select Agents and Toxins (DSAT) at the Centers for Disease Control and Prevention (CDC), part of the U.S. Department of Health and Human Services (HHS) ▪ The Agriculture Select Agent Services (AgSAS) at the Animal and Plant Health Inspection Service (APHIS), part of the U.S. Department of Agriculture (USDA) Overview & History 2001 anthrax attacks led to strengthening of program Title II of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 ▪ Legal authority for the current Federal Select Agent Program ▪ Required security measures in addition to biosafety measures ▪ Strengthened the regulatory authorities of HHS ▪ Granted comparable regulatory authorities to USDA 1. Establish and maintain a list of biological agents and toxins that have the potential to pose a severe threat to public health and safety. Consider: 1. Effect on human health 2. Degree of contagiousness and transmissibility 3. Availability of pharmacotherapies and immunizations 4. Other criteria, including children and vulnerable populations 2. Conduct a biennial review, or more often as needed Types of Select Agents and Toxins HHS-only agents (HHS has sole authority and responsibility to regulate) ▪ May only affect public health and safety ▪ Botulinum neurotoxins, Yersinia pestis, Smallpox virus USDA-only agents (USDA has sole authority and responsibility to regulate) ▪ May only affect animal and plant health; animal and plant products ▪ Foot-and-mouth disease virus, Rinderpest virus “Overlap” agents ▪ Subject to regulation by both agencies because they affect both humans and animals (requires interagency coordination) ▪ Bacillus anthracis, Brucella abortus, Rift Valley fever virus 67 agents and toxins on the HHS and USDA list: - 35 HHS-only - 21 USDA-only - 11 Overlap (HHS/USDA) ------------------------ - 14 Tier 1 agents https://www.selectagents.gov/SelectAge ntsandToxinsList.html Tier 1 Select Agents and Toxins Tier 1 is a subset of the select agents and toxins list that presents the greatest risk of deliberate misuse with the most significant potential for mass casualties or devastating effects to the economy, critical infrastructure, or public confidence HHS select agents and toxins USDA select agents (1) Bacillus cereus Biovar anthracis (1) Foot-and-Mouth Disease virus (2) Botulinum neurotoxin (2) Rinderpest virus (3) Botulinum neurotoxin producing species of Clostridium Overlap select agents (4) Ebola virus (1) Bacillus anthracis (excluding Pasteur (5) Francisella tularensis strain) (6) Marburg virus (2) Burkholderia mallei (7) Variola major virus (3) Burkholderia pseudomallei (8) Variola minor virus (9) Yersinia pestis U.S. Federal Biosafety & Biosecurity Oversight Key Regulatory Functions & Activities Promulgate the select agent regulations Provide oversight of possession, use, and transfer Conduct inspections and approve registrations Approve individual access to select agents & toxins Receive reports of a theft, loss, or release Take appropriate enforcement actions Serve as a resource on compliance with the regulations Types of Entities Registered with FSAP Registered Entities, by (2016) Lead Agency (2016) Total: 276 Total: 276 Private 6% APHIS/A gSAS 14% Academic 32% Non-federal Government 29% Federal Commercial Government 18% CDC/DSA 15% T 86% Source: 2016 Annual Report of the Federal Select Agent Program, October 2017 | www.selectagents.gov/annualreport2016.html FSAP Inspector Authority Without prior notification, CDC and APHIS must be allowed to inspect any site at which activities regulated under the select agents and toxins regulations are conducted and shall be allowed to inspect and copy any records relating to these activities. Regulatory Reference ▪ CDC: 42 CFR §73.18 Inspections ▪ APHIS: 7 CFR §331.18 Inspections ▪ APHIS: 9 CFR §121.18 Inspections FSAP Inspection Basics Biosafety ▪ Entity-specific biosafety plan ▪ Standards described in Biosafety in Microbiological and Biomedical Laboratories (BMBL, 5th edition) or equivalent ▪ NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (April 15, 2016) ▪ Notification of select agent release ▪ Select agent inactivation Training; Drills or Exercises Biosecurity ▪ Entity-specific security plan ▪ Registration and related security risk assessments ▪ Access controls ▪ Inventory and accountability – long-term select agents and toxins ▪ Notification of theft or loss ▪ Tier 1: 3 security barriers, suitability Select Agent Enforcement Voluntary action ▪ Corrective Action Plan (CAP) Administrative actions ▪ Denial of application ▪ Revocation or suspension of registration Civil money penalties ▪ Up to $250k for an individual for each violation ▪ Up to $500k for an entity for each violation Criminal ▪ Imprisonment for up to 5 years, a fine, or both Program Metrics Since 2003, there have been: No reported thefts of a select agent or toxin from a registered entity No deaths among laboratory workers No reported cases of illness or death in the general public due to work with these agents in regulated laboratories FSAP International Efforts Evaluation of laboratories outside of the U.S. on behalf of the National Institutes of Allergy and Infectious Diseases (NIAID) ▪ DSAT continues to conduct biosafety and security evaluations of laboratories outside the United States that are conducting research funded by NIAID. This is an ongoing program that began in 2004. ▪ This program promotes laboratory biosafety and security practices at the international level. ▪ DSAT inspectors have conducted laboratory assessments in Canada, United Kingdom, France, Netherlands, Sweden, Spain, Argentina, Hong Kong, and Thailand. FSAP remains ready to assist/support Department of Health and Human Services, Department of State, Department of Defense, as well as our CDC colleagues in engaging international partners and promoting biosafety and biosecurity practices. CDC International Efforts: National BioRisk Oversight Program Partnership between CDC’s Division of Global Health Protection (DGHP) and Division of Laboratory Systems (DLS) National BioRisk Oversight Program Goal: Assist foreign nations in the development of national biosafety and biosecurity legislation, and the subsequent implementation of that legislation Partnership: Between CDC’s Division of Global Health Protection (DGHP) and CDC’s Division of Laboratory Systems (DLS), leveraging both DGHP’s extensive global presence and DLS’s biosafety and biosecurity expertise in building laboratory capacity to meet national standards Sponsor: United States Government (USG)/Defense Threat Reduction Agency (DTRA)/Cooperative Bioterrorism Engagement Program (CBEP) – defines priority countries to engage Implementation Phase I Phase II Development of legislation, including high- Phase III consequence pathogens Development and revision of biosafety and list, inclusion and Implementation of biosafety exclusion criteria, and biosecurity technical rules and regulations and biosecurity biosafety and biosecurity legislation, rules, and technical requirements regulations Current Projects THAILAND (Phase 3) ETHIOPIA (Phase 2) Update: Biosafety and biosecurity Update: Biosafety and biosecurity technical requirements established. technical requirements drafted and Need to build capacity to implement translated into Amharic. Final requirements. draft submitted to the Government of Ethiopia for incorporation into national law. Years Funded: Years Funded: CY15, CY16, & CY18 CY16, CY17, & CY18 Current Projects TANZANIA (Phase 1) SENEGAL (Phase 1) Update: Completed development of Update: Completed initial meetings high-consequence pathogen list. with key stakeholders. Need to Need to begin drafting biosafety and begin development of high- biosecurity technical requirements. consequence pathogen list and criteria for inclusion and exclusion. Years Funded: CY18 & CY19 Years Funded: CY18 & CY19 Discussion www.selectagents.gov [email protected] or 404-718-2000 For more information please contact Centers for Disease Control and Prevention For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA 30333 Telephone: 1-800-CDC-1600INFO Clifton (232-4636)/TTY: Road NE, Atlanta, 1-888 -GA232 30333-6348 E-mail: [email protected], 1-800Web:-CDC www.cdc.gov-INFO (232-4636)/TTY: 1-888-232-6348 E-mail: [email protected] Web: www.cdc.gov The findings and conclusions in this report are those of the author(s) and do not necessarily represent the official The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Diseaseposition ofControl the Centers and forPrevention. Disease Control and Prevention. Centers for Disease Control and Prevention Office of Public Health Preparedness and Response.