The OIE Standard for BSE: A Case of International Risk Management

1
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
2
1994 WTO Sanitary and Phytosanitary (SPS)
Agreement

• SPS measures must be based on risk assessment and
  scientific principles.
• SPS measures only to the extent necessary to
  protect human, animal or plant life or health.
• Other legitimate factors (OLFs)?
• Members accept principle of equivalence of
  alternative SPS measures.

• Promotes SPS harmonization through international
  safe harbor standards
• Codex (Codex Alimentarius)
• OIE (International Office of Epizootics)
• ICPM (Interim Commission on Phytosanitary
  Measures)

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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).

4
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).

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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.).

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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.

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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
  (???)

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BSE incubation period variability distribution
and OIEs 8-year feed ban duration requirement
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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.

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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
  proteins 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.

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Confirmed BSE cases in UK cattle by year of birth
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Culling Provisions

• If 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.

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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

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OIE Decisional CriteriaImplicit OLFs

• Enforcement and regulatory design concerns
• Confidence of consumers and trading partners
• Balancing risk reduction and cost

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Conclusion

• 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.