# Presentation: 493066

## 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 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)

## 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 

## 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 

## 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

## 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.