Overview of Federal Regulations, Guidelines The comments and slides presented here solely represent my and Policies Governing Biosafety and views and do not represent the positions of Biocontainment in High Containment the U.S. Government or of AAAS… Laboratories All content and discussion is solely and exclusively taken from publically available material. Marci Wright, PhD Presentation to the Biocontainment Work Group Department of Health and Mental Hygiene State of Maryland 15 November 2012 Outline The history of the issue with the Federal government Government Accountability Office How many Trans-Federal Task Force on Optimizing Biosafety and BSL‐3 and BSL‐4 Biocontainment Oversight (2009)* labs are in the US? What the Trans-Federal Task Force determined Framework for existing Federal oversight Do they have sufficient Role of state and local oversight Recommendation1.2: Develop a Federal Registry Federal biosafety oversight? Existing Federal oversight Statutes, Regulations, Guidelines and Policies Sen. Joseph Lieberman (D‐CT) Are they secure? Industry Best Practices and an International Model Sen. Barbara Collins (R‐ME) Senate Committee on Homeland Security & Governmental Affairs Government Accountability Office Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight 2007 GAO report: 2007: Chaired by HHS and USDA “no single Federal agency has the mission and, therefore, is accountable for Charge: evaluate existing Federal tracking the number of all BSL-3 and BSL-4 labs within the United States….” oversight of high (HCL) and “no Federal agency is responsible for determining the risk associated with maximum (MCL) containment expanding the number of high and maximum containment laboratories.” laboratories, and make recommendations for enhancing Federal oversight without hindering 2008 Commission on Weapons of Mass Destruction report: research. “…consider centralizing the regulatory functions for biosafety and biosecurity by 2009: Identified16 recommendations developing a new oversight mechanism for high-containment laboratories….” to enhance Federal oversight, including a recommendation to establish a Federal registry of all U.S. HCLs (2.2) The Report of the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight (July 2009) http://www.phe.gov/Preparedness/legal/boards/biosafetytaskforce/Pages/default.aspx. Trans-Federal Task Force on Optimizing Biosafety Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight and Biocontainment Oversight Existing HCL Oversight Recommendation 1.2: “Multiple, complementary, and sometimes overlapping biosafety and “Develop a registry of all Issue: no USG mechanism to identify biocontainment oversight and track all HCLs in the U.S. requirements exist at [these] levels”: high and maximum containment research Identification/tracking/accounting Capacity assessments Federal facilities in the United State Oversight quality assurance Municipal States” Information sharing Institutional Short and long term steps to explore Layered and deliberately redundant mechanisms to address this gap in approach to lower risk from working biosafety and biocontainment with hazardous biological agents oversight. The Report of the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight (July 2009) The Report of the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight (July 2009) http://www.phe.gov/Preparedness/legal/boards/biosafetytaskforce/Pages/default.aspx. http://www.phe.gov/Preparedness/legal/boards/biosafetytaskforce/Pages/default.aspx. HCL or High Containment Lab Definitions HCL or High Containment Lab Definitions Biosafety Level 3 Laboratory (Minimal) Biosafety Level 3 Laboratory (Minimal) Engineering controls: Engineering controls: Secure access via anteroom Secure access via anteroom Two interlocking doors Two interlocking doors Sealed penetrations Sealed penetrations Hands free sink at lab exit Hands free sink at lab exit Ducted, negative airflow into lab Ducted, negative airflow into lab Specialized exhaust (e.g. HEPA) Specialized exhaust (e.g. HEPA) Administrative controls: Administrative controls: Occ Health program Occ Health program Initial and, thereafter, annual Initial and, thereafter, annual certification/validation certification/validation Personnel training/proficiency Personnel training/proficiency Work Practices controls: Work Practices controls: Enhanced PPE Enhanced PPE Open manipulations in BSC or Open manipulations in BSC or other 1° containment other 1° containment Decon on site Decon on site Image taken from the WHO Biosafety Manual, 3rd Ed. 2004 Image taken from the WHO Biosafety Manual, 3rd Ed. 2004 CDC/NIH. Biosafety in Microbiological and Biomedical Laboratories, 5th Edition. 2007 CDC/NIH. Biosafety in Microbiological and Biomedical Laboratories, 5th Edition. 2007 Definitions Federal Regulations Some Infectious Microorganisms That May Be Manipulated Using BSL3 principles, practices and facilities* Recombinant or Select Non-recombinant synthetic Agents non-synthetic microorganisms microorganisms OSHA General Duty OSHA Standards Select Agent Regulations Import / Transportation Select Agents: Regulations Risk Group 2: Clostridium botulinum, Bacillus anthracis Risk Group 3: Burkholderia mallei, pseudo, Monkeypox Virus, SARS-CoV, HPAI aH5N1 Non Select Agents: Risk Group 2: Chlamydophila psittaci, C. trachomatis Risk Group 3: Mycobacterium tuberculosis; 1957 non/com hH2N2, JEV, HIV, WNV Risk Group 4: Herpes B virus (simian) * Determination of biosafety levels are based on biological risk assessments. Refer to Biosafety in Microbiological and Biomedical Laboratories, 5th Edition (CDC/NIH, 2007) for a discussion of the biological risk assessment process. The Report of the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight (July 2009) Risk Groups: NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. March 2013 http://www.phe.gov/Preparedness/legal/boards/biosafetytaskforce/Pages/default.aspx. STATUTE STATUTE OSH Act, 1970 OSH Act, 1970 Occupational Safety and Health Administration Occupational Safety and Health Administration Laboratory Safety Standards General Duty Clause “furnish to each of [its] employees employment and a place of employment which are Exposure Control Personnel Training: Record Keeping: free from recognized hazards that are causing or likely to cause death or serious Plan: physical harm to [its] employees.” Purpose: Scope: Responsibilities: Exposure All occupational Hazard determination settings that are Communications This provision allows All occupational Identify and mitigate covered by OSH Act. OSHA to enforce settings that are serious hazards Procedures for Training records workplace safety covered by OSH Act. based on national evaluating incidents All employees for even when specific consensus standards whom the standard is Incident records hazards are not Includes all U.S. and industry best Implementation of relevant covered in an HCLs. practices (CDC, NIH standard and risk OSHA 300 Log existing standard. NIOSH, ANSI). mitigation SOPs Includes all U.S. HCLs For HCLs: administrative, work 29CFR1910 29 U.S.C. 654(a)(1), Section 5(a)(1) practice, and engineering controls. STATUTE STATUTE OSH Act, 1970 OSH Act, 1970 NSP Act, 2001 Occupational Safety and Health Administration Occupational Safety and Health Administration Personal Protective Equipment Standards Bloodborne Pathogens Standard “protective equipment, including personal protective equipment for eyes, face, head, eliminate or minimize employee exposure to human blood or other potentially and extremities, protective clothing, respiratory devices,andprotective shields infectious materials. and barriers, shall be provided, used, … wherever it is necessary by reason of hazards … capable of causing injury or impairment...” Eye and Face Respiratory Protection: Hand Protection: Purpose: Scope: Responsibilities: Protection: Full or partial face Measures to prevent Protects workers All employees with Identify and mitigate Eye or face shields respiratory protection to absorption of harmful from pathogenic “reasonably hazards, including to prevent injury from prevent transmission of substances; … microorganisms that anticipated” needlestick hazards hazards: liquid aerosols through filter punctures; chemical are present in human exposure to human chemicals, acids or media. burns; thermal burns blood and can cause blood and body fluids Write/implement ECP caustic liquids, gases Medical evaluation disease in humans, Train employees or vapors Annual fit test Handwashing facilities including HBV and Includes all U.S. Offer HBV vaccine Mucous membranes HIV. HCLs in which Keep records Soap / paper towels N-95 respirators, PAPRs Gloves applicable work is Safety glasses, performed 29CFR1910.1030 29CFR1910.132-134/138 goggles, face shields STATUTE STATUTE OSH Act, 1970 OSH Act, 1970 Occupational Safety and Health Administration Occupational Safety and Health Administration Additional Relevant Standards Proposed Standard: Provisions in the following standards also help eliminate or minimize exposure to Reducing Occupational Exposure to LAIs biological agents and toxins: Rule Making Process OSHA must demonstrate that the standard: Occupational Exposure to Hazardous Chemicals in Laboratories (Laboratory Standard) 29 CFR 1910.1450 1. substantially reduces a significant risk of material impairment