The OIE Standard for BSE A Case of International

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					The OIE Standard for BSE: A Case
 of International Risk Management
            Mark Powell
    USDA Office of Risk Assessment
      and Cost Benefit Analysis
                                  IAFP 2005
                              Baltimore, MD
                              17 August 2005
1994 WTO Sanitary and Phytosanitary
        (SPS) Agreement
• SPS measures must be          • Promotes SPS harmonization
  based on risk assessment        through international “safe
                                  harbor” standards:
  and scientific principles.
                                   – Codex (Codex Alimentarius)
• SPS measures “only to the        – OIE (International Office of
  extent necessary to protect         Epizootics)
  human, animal or plant life      – ICPM (Interim Commission
  or health.”                         on Phytosanitary Measures)
• Other legitimate factors
• Members accept principle of
  equivalence of alternative
  SPS measures.
      OIE Principles & Standards
• Principles of Risk Management: “The objective is to
  manage risk appropriately to ensure that a balance is
  achieved between a country's desire to minimise the
  likelihood or frequency of disease incursions and
  their consequences and its desire to import
  commodities and fulfil its obligations under
  international trade agreements.”
• Disease-specific standards for classifying animal
  health status of countries or regions based on numeric
  and/or narrative criteria (qualitative risk assessment).
     OIE Decisional Procedures
• Traditionally, decisions on OIE standards are
taken on the basis of consensus.
• However, the OIE General Rules provide for
decisions on a simple majority basis.
• For example, the 2005 amendments to the OIE
standard for BSE were adopted by resort to the
voting procedure, with nine members voting
against and eight members abstaining (total of
167 members).
     OIE Decisional Procedures
“Coalition building is an absolute necessity to
get any issue passed the way we [U.S.] may want
it. I watched in amazement as [a U.S. official]
lobbied the „Hemisphere of the Americas‟ to
make a few changes in the proposed BSE rule
this year. Since there are 150 plus members in
OIE, you must have at least 80 votes to have an
issue go your way. This is why the EU
dominates the vote in many instances” (Zirkle,
E. 1999. US Animal Health Assoc.).
        OIE Standard for BSE
  Controversy Atypical or Harbinger?
• Report from 1998 OIE General Session: “The bovine
spongiform encephalopathy (BSE) code was again the
most controversial. After a protracted debate lasting two
sessions and a substantial rewrite over two days, an
amended code was adopted” (Murray, G. 1998.
Australian Veterinary Journal).
• Among several unresolved issues that remained “under
study” after the 1998 OIE General Session was the
definition of the minimum period for an effective MBM
feed ban.
              Feed Ban Duration
• 8 year MBM feed ban duration for minimal BSE risk adopted
  in 1999
• EU Scientific Steering Committee: “8 years corresponds with
  the upper end of the BSE incubation period.” “This period [8
  years] is chosen ... in order to provide a safety margin in
  comparison to the average incubation period of 5 years.”
• Most EU countries had enacted feed ban by 1990. US and
  Canada implemented feed bans in 1997.
• OIE Ad Hoc BSE Group: Should exceed 92 months - 95th
  percentile (76 mos) of the incubation period, plus the
  minimum period for propagation (16 mos), based upon
  infectivity within the CNS (???)
BSE incubation period variability distribution and
  OIE‟s 8-year feed ban duration requirement
Cumulative Percentile

                                                                               Incubation Period
                                                                               16 mos
                                                                               76 mos
                                                                               Feed Ban Duration
                               0   1   2   3    4   5   6     7   8   9   10
                                               Time (years)
 Feed Ban Composition and Coverage
• Until 2005 amendments to the OIE Terrestrial Animal Health
  Code, criteria for BSE-free or provisionally-free country status
  required a ban on feeding ruminants MBM derived from any
  animal source if the country had never reported an indigenous
  case of BSE.
• For countries where the last indigenous case of BSE was
  reported more than 7 years ago, the criteria specified that the
  feed ban applied to MBM derived from ruminants.
• Countries compliant with OIE guidelines for BSE surveillance
  that had not detected any indigenous BSE cases were subject
  to a more stringent ruminant feed restriction than were
  countries where BSE previously had been reported.
 Feed Ban Composition and Coverage
• EU 2001 banned feeding processed animal protein from all
  species to all farmed animals (w/ exceptions).
• European Commission (2003): states that “[p]roteins derived
  from non-ruminants have not been implicated in BSE cases,
  and there is no scientific evidence pointing at the involvement
  of non-ruminant protein in BSE transmission. It has however
  proved necessary to ban the use of non-ruminant [protein] in
  feed for control reasons. In particular, analytical methods to
  differentiate ruminant from non-ruminant proteins in feed are
  not available. Therefore, if non-ruminant proteins are being
  used in feed, it is not possible to detect the presence of
  potentially infected ruminant proteins.”
• This position presumes that end-product testing is the only
  means of achieving the desired level of regulatory compliance.
Confirmed BSE cases in UK cattle by
           year of birth
                                                                           UK Reinforced
            35000                                     UK Initial Feed
                                                                             Feed Ban -
                                                      Ban - July 1988
            30000                                                           August 1996
BSE Cases

                1974 1976 1978 1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002

                                       Year of Birth of BSE Cases
             Culling Provisions
• “[I]f the results [of the epidemiologic investigation]
  are inconclusive, all cattle born in the same herd as,
  and within 12 months of the birth of the BSE cases ...
  are completely destroyed.”
• OIE Ad Hoc Expert Consultation on BSE (1991):
  “The depopulation of affected herds does not
  contribute significantly to the control of disease. The
  meeting understood that the main reason for
  depopulating herds is to maintain consumer
  confidence at home and trade with other countries.”
Risk Management is a Balancing Act
- Nobel Prize recipient Dr. Stanley Prusiner was “interested in
the [OIE] justification for recommending targeted surveillance
of bovine populations as opposed to testing all animals for
human consumption.”
- OIE Director General, Dr. Bernard Vallat “noted that the
standard setting process of the OIE is a difficult balance
between science and practical recommendations
commensurate with the assessment of human and animal
health risks, within the global resources available for consumer
and animal protection linked with food safety.”
                                 OIE Press Release June 3, 2004
         OIE Decisional Criteria
             Implicit OLFs
• Enforcement and regulatory design concerns
• Confidence of consumers and trading partners
• Balancing risk reduction and cost
• SPS Agreement prescribes the discipline of scientific risk
  assessment to prevent disguised trade barriers.
• OIE and other international SPS organizations make a valuable
  contribution as multilateral risk management agencies that
  negotiate “safe harbor” standards to facilitate trade and prevent
  unreasonable risks.
• Because risk management decisions inherently involve
  considerations beyond the scope of science, some tension
  between the decisional criteria of the SPS Agreement and the
  SPS agencies is to be expected.
• To the extent that an international standard is vague or
  ambiguous, this presents a challenge to countries to
  demonstrate or judge the equivalence of national standards
  based on the international standard.