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Regulatory Aspects, Standards,and Guidelines

Regulatory Aspects, Standards,and Guidelines. EMD 545b Lecture #4. OSHA Law, Standards, and Directives. Related to Biohazards. OSHA Act of 1970. Section 1, An Act To assure safe/healthful working conditions Section 2, Congressional Findings/Purpose

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Regulatory Aspects, Standards,and Guidelines

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  1. Regulatory Aspects, Standards,and Guidelines EMD 545b Lecture #4

  2. OSHA Law, Standards, and Directives Related to Biohazards

  3. OSHA Act of 1970 • Section 1, An Act • To assure safe/healthful working conditions • Section 2, Congressional Findings/Purpose • …to assure so far as possible…safe/healthful working conditions and to preserve our human resources

  4. Section 5 Duties“General Duty Clause” • (5)(A)(1)Each Employer shall furnish: • employment • workplace free from recognized hazards that are causing death or serious physical harm • (5)(A)(2) Each Employer shall comply with OSHA Standards

  5. General Duty Clause • Applicability to Biohazards: • recognized hazard exists (substantial probability that death or serious harm could occur) • Risk Group 3/4 Agents • Some Risk Group 2 Agents • existing measure of abatement • economically/technologically feasible (BMBL, etc)

  6. Section 17 Penalties • A) willful or repeat violation (5,000 < x < 70,000) • B) serious violation (up to 7,000 each) • C) less than serious (up to 7,000 each) • D) extending beyond period of correction (up to 7,000 each day) • Employer pays (who is your employer?)

  7. Section 17 Penalties • E) willful resulting in death (10,000 and 6 months jail). • repeat of E): 20,000 and 1 year jail • knowingly provide false info (10,000 and 6 months jail) • violations of posting requirements (7,000) • killing an OSHA Inspector - life in prison

  8. OSHA BBP Standard 1910.1030 • Applicable to all occupational exposure to blood or other potentially infectious materials. • Bloodborne Pathogens: • Pathogenic microbes present in blood which can cause disease in humans (include, but not limited to HIV, HBV, and HCV).

  9. “OPIM” • Other Potentially Infectious Materials • human body fluids • amniotic, cerebrospinal, pericardial, peritoneal, pleural, semen, synovial, vaginal secretions, saliva in dental settings, unknown fluids, any body fluid visibly contaminated with blood. • unfixed human tissues or organs (except skin) • cell cultures/animal tissues containing BBP’s

  10. Exposure Control Plan • Written document, updated and reviewed annually • Identifies occupationally exposed employees • Outlines procedures to protect them • Documents ongoing consideration of new engineering controls

  11. Exposure Determination • Evaluate new employees at time or hire • Evaluate existing employees who change jobs • List of jobs where all employees have exposure • List of jobs where some have exposure • detailed list of tasks that include exposure

  12. Exposure Control Plan • Hepatitis B Vaccine Offer • free, 3 shot vaccination • offer w/in 10 days of hire • signed declination statement • Training • at time of hire, before work involving exposure • retraining each year w/in 365 days

  13. Methods of Compliance • Universal Precautions • Infection control concept where all human blood and certain body fluids are treated as if known to be infectious for HIV or HBV. • Sharps Precautions • Sharps w/ Engineered Sharps Injury Protections (SESIP): non-needle sharp or needle device or other sharp with built-in safety feature or mechanism that effectively reduces risk of exposure.

  14. Methods of Compliance • Sharps precautions, sharps containers • Good work practices • Leakproof containers for transport, storage • Labels, signs • Decontamination • Personal Protective Equipment • free, all sizes, appropriate for task, replacement supplies, laundered by employer

  15. Records • Medical (duration of work + 30 years) • post-exposure evaluation and follow-up • Training (maintained 3 years) • Sharps Injury Log • type, brand of sharp • Dept., work area of incident • incident description • SESIP evaluation applicable?

  16. Scenario #1 • New employee with occupational exposure to human blood and other potentially infectious materials has just been hired by your institution. • Outline OSHA BBP Standard requirements for this employee

  17. Scenario #1 - New Employee • Written exposure determination (yes/no) • If yes, add to database (active w/exposure) • Job title/classification (all/some exposed?) • Tasks/procedures (update ECP if needed) • Site specific BBP training before working • HBV vaccine offer w/in 10 days of hire (yes-3 shot series, no-sign declaration)

  18. Scenario #1- New Employee • Healthcare professional’s written evaluation for HBV vaccine • Offer retraining every 365 days, updates as necessary • Evaluate prior work experience of employee • Audit procedures, facility, supervision

  19. Scenario #2-HIV Experiment • An existing employee from your bloodborne pathogen program submits a request to work with HIV in cell culture. • What is the appropriate Institutional response?

  20. Scenario #2-HIV Work • Document prior work experience • Demonstrated proficiency with techniques, safety practices,equipment and operations • Adequate trained supervision • Appropriate facility (lab inspection) • Medical Surveillance (serum storage, post-exposure prophylaxis

  21. Scenario #3 - Exposure Response • An employee at your institution has just experienced an exposure to human blood. • What should happen next?

  22. Scenario #3 - Exposure Response • Treat exposed area immediately-wash/flush • Promptly seek medical evaluation (1-2 hr): confidential and follow-up • Document the route of exposure and circumstances • Attempt to ID source individual (HIV/HBV/HCV)

  23. Scenario #3 - Exposure Response • Collect exposed worker’s blood with consent (test baseline, 6, 12 and 36 weeks) • Hold blood sample for at least 90 days • HIV HBIG post exposure prophylaxis is available • Counseling offered • Worker aware of signs/symptoms of Agents

  24. Scenario #3 - Exposure Response • Healthcare provider must receive • copy of regulation • description of job duties • documentation of exposure routes • results of source individuals blood tests • all relevant medical records

  25. Scenario #3 - Exposure Response • Health care professional’s written opinion • to employee w/in 15 days of completion • employee instructed on conditions that may require further evaluation • All other findings/diagnoses CONFIDENTIAL

  26. Biowarfare/Bioterrorism • Geneva Protocol (1925) • Biological Weapons Convention (1972) • Biological Weapons Act (1989) • Public Law 101-298 • Chemical and Biological Weapons Control and Warfare Elimination Act of 1991 • Public Law 102-182

  27. Anthrax Letters - Fall 2001 • 5 deaths (FL, NJ, NY, CT) • 22 total infections • Mass terror • White powder fever! • Unsolved crime

  28. Other “bioterror” events • Salmonella in salad bars • Shigella in pastries • 125-I Saxitoxin in take-out food • Ricin at IRS building -thwarted before use • UCONN anthrax • Texas Tech • lost Yersinia samples • Hoaxes

  29. Select Biological Agents/Toxins • Anti-terrorism and Effective Death Penalty Act of 1996 (Public Law 104-132) • Additional Requirements for Facilities Transferring or Receiving Select Agents 42 CFR Part 72.6 (Select Agent Rule) • USA Patriot Act (Public Law 107-56 • Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001 • Possession now addressed

  30. DHHS-CDC, USDA-APHIS • Public Health Security and Bioterrorism Preparedness Response Act of 2002 • Public Law 107-188 • 42 CFR Part 73, 9 CFR Part 121, 7 CFR Part 331 • Regulatory language for USA PATRIOT ACT • Lists of Select Agents

  31. Select Agent List DHHS-CDC • Crimean Congo haemorrhagic fever virus • Coccidiodiodes posadasii • Ebola viruses • Cercopithecine herpesvirus 1 • (Herpes B virus) • Lassa fever virus • Marburg virus • Monkeypox virus • Rickettsia prowazekii • Rickettsia rickettsii • South American haemorrhagic fever viruses • Junin, Machupo, Sabia, Flexal, Guanarito

  32. Select Agent List DHHS-CDC • Tick-borne encephalitis complex (flavi) viruses • Central European tick-borne encephalitis • Far Eastern tick-borne encephalitis • Russian spring and summer encephalitis • Kyasanur forest disease • Omsk hemorrhagic fever • Variola major virus (Smallpox virus) • Variola minor virus (Alastrim) • Yersinia pestis

  33. Select Agent List DHHS-CDC • Abrin • Conotoxins • Diacetoxyscirpenol • Ricin • Saxitoxin • Shiga-like ribosome inactivating proteins • Tetrodotoxin

  34. DHHS-CDC USDA Overlap Agents • Bacillus anthracis • Brucella abortus, B. melitensis, B. suis • Burkholderia mallei, B. pseudomallei • Botulinum neurotoxin producing species of Clostridium • Coccidioides immitis • Coxiella burnetii • Eastern equine encephalitis virus • Hendra virus • Francisella tularensis • Nipah virus

  35. DHHS-CDC USDA Overlap Agents • Rift Valley fever virus • Venezuelen equine encephalitis virus • Botulinum neurotoxin • Clostridium perfringens epsilon toxin • Shigatoxin • Staphylococcal enterotoxins • T-2 Toxin

  36. Select Agent List USDA • Akabane virus • African swine fever virus • African horse sickness virus • Avian influenza virus (highly pathogenic) • Blue tongue virus (Exotic) • Bovine spongiform encephalopathy agent • Camel pox virus • Classical swine fever virus • Cowdria ruminantium (Heartwater) • Foot and mouth disease virus • Goat pox virus

  37. Select Agent List USDA • Lumpy skin disease virus • Japanese encephalitis virus • Malignant catarrhal fever virus (exotic) • Menangle virus • Mycoplasma capricolum/M.F38/M. mycoides capri • Mycoplasma mycoides mycoides • Newcastle disease virus (velogenic) • Peste Des Petits Ruminants virus • Rinderpest virus • Sheep pox virus • Swine vesicular disease virus • Vesicular stomatis virus (exotic)

  38. Select Agent List APHIS • Candidatus Liberobacter africanus • Candidatus Liberobacter asiaticus • Peronosclerospora philipinensis • Ralstonia solanacearum race 3, biovar 2 • Schlerophthora rayssiae var zeae • Synchytrium endobioticum • Xanthomonas oryzae pv. oryzicola • Xylella fastidiosa (citrus variegated chlorosis strain)

  39. USA PATRIOT ACT • Restricted person (can’t possess, receive, transport) • under indictment for a crime punishable by imprisonment for a term > 1 year • has been convicted of crime punishable by imprisonment > 1 year • fugitive from justice • unlawful user of a controlled substance • illegal alien • adjudicated as a mental defective • dishonorable discharge from US Armed Services

  40. Restricted Person • Is an alien who is a national from a country that has history of supporting terrorism: • Syria • Sudan • Lybia • Cuba • Iran • Iraq • North Korea

  41. Components of Bioterrorism Law • Registration of individuals (possess, access) • Registration of agents, location • Description of storage and security requirements • Pre-authorization of transfers • Select Agent Inventory

  42. Components of Bioterrorism Law • Restricted Access • Facility • fences, guards, video monitor • Building • locked access (key, keycard, guard, video) • floors (keycard access, alarms, labels) • Lab • locked, lockboxes, away from office and traffic areas • Security Training/Manuals/Inspections

  43. Components of Bioterrorism Law • Security Plan • procedures for reporting loss of keys, password • reporting suspicious people/packages • removal of unauthorized personnel • reporting release, loss, or theft • Access control • Emergency response plans • Inventory tracking quantities of SA’s

  44. NIH Guidelines for Research Involving rDNA Molecules (April, 2002)

  45. NIH Guidelines - April 2002 • NIH - OBA (Office of Biotechnology Activities) • Outline scope of regulated rDNA work and required containment levels (changes approved by NIH-OBA) • Applicability • NIH Sponsored Institutions • NIH Supported projects (US & Abroad)

  46. Responsibilities: Institution • Ensure full conformity with Guidelines • Establish an IBC • Appoint a BSO (if necessary) • Ensure adequate expertise for protocol review (plant, animal, human gene transfer) • Training (IBC/BSO/PI’s/Lab staff) • Health Surveillance (BL3/Large scale)

  47. Responsibilities - IBC • 5 members (2 from community) • Expertise (rDNA, biosafety, containment, legal) • Annual report to NIH-OBA (roster/CV’s) • Assess • Containment level, facilities, procedures • Develop emergency plans, report violations

  48. Responsibilities: Biosafety Officer • IBC Member • Inspections • Report problems to IBC • Develop emergency plans • Advise on lab security

  49. Responsibilities: Principal Investigator • Full compliance with Guidelines • Can’t start/modify non-exempt work w/out approval • Report violations w/in 30 days • Make initial determination of containment • Instruct/train lab staff • Supervise safety performance

  50. Section III: Experiments covered by the NIH Guidelines • Require approval before initiation • III-A: Transfer significant drug-resistant trait (IBC/RAC review/NIH Director) • III-B: Cloning toxins (IBC/NIH-OBA) • III-C: Human gene transfer (IBC/IRB/FDA NIH-OBA registration) • III-D: Risk group 2-4 & restricted, defective virus in cell culture, animals, plants, large scale

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