Post Approval Monitoring: The Role of the Institutional Biosafety Committee and Institutional Animal

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Post Approval MonitoringThe Role of the
Institutional Biosafety Committee and
Institutional Animal Care and Use
CommitteeAAALAC Perspective

• Douglas Stone, D.V.M., M.S., DACLAM
• Director
• Laboratory Animal Medical Services
• University of Cincinnati

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AAALAC

• Guide for the Care and Use of Laboratory
  Animals
• only has 12 musts
• 3 of these 12 are under the heading of
  Occupational Health and Safety

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AAALAC References ResourcesIn addition to the
Guide

• 20 reference documents for US institutions
• 7 of 20 relate to occupational health safety
• http//www.aaalac.org/accreditation/resources.cfm

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AAALAC References Resources

• 3. Biosafety in microbiological and biomedical
  laboratories.
• DHHS Pub. No. (CDC) 93-8395, May 1999.
  Division of Safety, NIH, Bldg. 31, Rm. 1C02,
  Bethesda, MD 20892. 301/496-2801.
  www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm
• 4. Criteria for a recommended standard
  occupational exposure to waste anesthetic gases
  and vapors.DHEW Pub. No. (NIOSH) 77-140, March
  1977. www.cdc.gov/niosh/77-140.html

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AAALAC References Resources

• 9. Guidelines for the prevention and treatment of
  B Virus infection in exposed persons.Clinical
  Infectious Diseases, 1995, 20421-439.
• 10. Guidelines for Research Involving Recombinant
  DNA MoleculesApril 1988 (63 FR 26018).
  http//www4.od.nih.gov/oba/rac/guidelines/guidelin
  es.html

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AAALAC References Resources

• 14. Occupational Health and Safety Administration
  Standards29 CFR 1910.1030 - Bloodborne
  pathogens. (Adopted September 1998)
  http//www.osha.gov/pls/oshaweb/owadisp.show_docum
  ent?p_tablestandardsp_id10051

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AAALAC References Resources

• 16. Occupational Health and Safety in the Care
  and Use of Research Animals1997. National
  Research Council, National Academy of Sciences.
  (Adopted September 1997) National Academy Press,
  2101 Constitution Ave., NW, Lockbox 285,
  Washington, DC 20055. 800/624-6242.
• http//www.nap.edu/catalog/4988.html

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Definitions

• IACUC
• IBC

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The Official Definition

• Institutional Biosafety Committees (IBCs) were
  established under the NIH Guidelines for Research
  Involving Recombinant DNA Molecules to provide
  local review and oversight of nearly all forms of
  research utilizing recombinant DNA.  Over time,
  many institutions have chosen to assign their
  IBCs the responsibility of reviewing a variety of
  experimentation that involves biological
  materials (e.g., infectious agents) and other
  potentially hazardous agents (e.g., carcinogens).
  This additional responsibility is assigned
  entirely at the discretion of the institution.

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Problems

• Many (including AAALAC) assume the IBC really is
  an IBC
• Occupational Health is often a separate and
  distinct unit from Environmental Health and
  Safety (aka Biosafety Office)

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Problems

• One tracks patients (Occ Med)
• One tracks hazards (EHS)
• One tracks users (IACUC)
• One tracks DNA (and sometimes biological safety
  and sometimes not)
• One tracks animals and people (DLAM)
• All need need to be in agreement

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Situation Report

• IACUC
• IBC
• Environmental Health Safety
• Animal Care Unit

• Occupational Medicine
• Protocols
• As written
• As implemented

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Post Approval Monitoring
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Post Approval Monitoring Definition

• Monitoring the active status of a protocol
  against the actual status of a protocol.

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Post Approval Monitoring

• This is what AAALAC does routinely in the course
  of conducting a site visit
• Executive Session

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PAM - Outside Agencies

• USDA
• AAALAC

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Who discovers problems ?

• Animal rights mole
• Regulatory agency
• Internal whistleblower
• IACUC or other component of the animal care and
  use program

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The source of many problems is.protocol drift
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Protocol drift may be purposefulor
inadvertent.
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The ramifications of drifting from approved
procedures/acceptedpractices depend on
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Seriousness of the infraction

• Animal welfare is compromised
• Occupational health and safety (personnel) are
  put at risk
• Laws are broken

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Precautions that guard against protocol drift

• Well written protocols
• Well-trained and empowered technical staff
• Access to protocols

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Precautions that guard against drift

• Appropriate (short?) organizational reporting
  chain
• Unambivalent lines of authority and
  responsibility and a clearly designated
  decision-maker

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Recent trend Institutional Compliance Officers
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IBC vs IACUC Conflict / Conflict Resolution

• Common membership on the IACUC and IBC
• Prevents problems
• What happens when the biosafety officer turns
  the IACUC semiannual into a safety inspection ?
• Can cause problems

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Reporting

• Drifting too far can result in reporting
• Be familiar with OLAW and APHIS requirements for
  prompt reporting
• Section 2. f. of AAALAC Rules of Accreditation

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• "The accredited unit shall submit an annual
  report which describes elements of the animal
  care and use program as specified by AAALAC
  International. In addition, the accredited unit
  shall promptly notify AAALAC International (e.g.,
  through copies of correspondence) of adverse
  events relating to the animal care and use
  program. Examples include investigations by the
  USDA or OLAW, as well as other serious incidents
  or concerns that negatively impact animal
  well-being."

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Sanctions

• No guidance from OLAW or APHIS
• Common sense punishment should fit the crime
• Repeat offenders present special
  circumstance/problem (how many strikes until
  you're out?)

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Self Reporting

• If an institution self reports a serious issue
  should it suffer adverse decisions from OLAW /
  USDA / AAALAC ?

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Good animal care is everybodys business
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Example 1

• A review of animal use protocols noted some
  protocols involving biohazardous agents.
  However, there was no documentation in the file
  that the procedures had been satisfactorily
  reviewed by biosafety personnel. In addition,
  the protocol form question regarding biohazardous
  use, was confusing in that it did not indicate if
  the agent used was hazardous to personnel or
  animals.

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Example 2

• The overall occupational health and safety
  program was satisfactory, however, there was a
  concern expressed by the site visit team that
  staff who choose to go their own private
  physician, rather than the U of X physician, were
  satisfactorily included in an occupational health
  program. There was no documentation that these
  individuals were properly vaccinated or that a
  fitness to work evaluation had been done. The
  extent and level of participation of personnel in
  the program should include consideration of the
  exposure intensity, duration, and frequency.
  Council must be assured that all personnel at
  risk are appropriately considered under your
  occupational health and safety program.

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Example 3

• This laboratory appeared to be a hazardous
  satellite waste storage facility and should be
  evaluated as such by the appropriate hazardous
  waste personnel to ensure satisfactory personnel
  safety. In addition, while the IACUC had entered
  this laboratory recently during the semi-annual
  inspection, this area was not satisfactorily
  evaluated to ensure compliance with the Guide,
  Animal Welfare Act Regulations or Public Health
  Service Policy. This area, was an exception to an
  otherwise excellent animal care and use program.

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Example 4

• In addition, there were two commercial flammable
  and two hazardous waste cabinets in this
  laboratory, all totally full. Some of these
  cabinets had five gallon containers stored on top
  these cabinets, while others cabinets had
  cardboard boxes stored on top within 18 inches of
  the ceiling (a state fire code violation). This
  should be evaluated by university safety
  personnel to ensure a safe workplace in
  compliance with regulations.

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Example 5

• Several electrical outlets covers were missing
  with exposed wires.

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Example 6

• Brucella abortus (vaccinal strain) was used in
  guinea pigs under BSL-2 conditions. According to
  Biosafety in Microbiological and Biomedical
  Laboratories (BMBL), experimental animal studies
  with pathogenic Brucella are to be conducted
  under BSL-3 conditions. Additionally,
  appropriate signage, including the universal
  biohazard symbol, must be utilized at entrances
  to areas containing biohazardous agents .

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Example 7

• Protocol "IBC 83" entitled "Mucosal
  Immunity and Control of Herpetic Infection" was
  not satisfactorily reviewed for biosafety. The
  methodology contained in this IBC protocol
  addressed only Salmonella and did not include any
  review of Herpes use despite the title. No
  review of biosafety or risk assessment for
  personnel was done for either agent. The animal
  protocol that correlated to this IBC protocol
  (IACUC protocol 216) included the use of both
  both Herpes and Salmonella agents in animals, but
  did not address biosafety concerns either agent.
  Animal care personnel were not informed of the
  biohazard potential of either agent.
• Reviewer comment THE IBC PROTOCOL DID NOT EVEN
  MENTION THE WORD HERPES. JUST TO GIVE YOU AN
  IDEA OF HOW POORLY IT WAS REVIEWED FOR BIOSAFETY.

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Example 8

• Recapped needles were observed in various
  locations, e.g., Brown Hall room 456. As stated
  in Occupational Health and Safety in the Care and
  Use of Research Animals (NRC, 1997), care should
  be taken to avoid or minimize injuries from
  needles and syringes, which includes disposal of
  sharps. To adequately protect personnel, the
  institution should review policies for sharps
  disposal, particularly when dealing with known
  biohazardous agents. If needles must be recapped,
  safe techniques should be required.