Proposal P238 - BSE - Risk Assessment and Risk Management Strategy

2 October 2002

PRE - FINAL ASSESSMENT REPORT (s.37)

Full Report [ pdf  857 kb ]

EXECUTIVE SUMMARY AND STATEMENT OF REASONS

Variant Creutzfeldt-Jakob disease (vCJD) is a fatal disease caused by the transmission of the bovine spongiform encephalopathy (BSE) agent to humans via consumption of beef and beef products contaminated with the infectious agent.

On January 8, 2001 Australia introduced an immediate suspension of the importation of beef products and virtually all foods containing beef from 30 European countries. This suspension, introduced as an interim measure to protect the public against exposure to the BSE agent, was implemented under the Imported Food Control Act 1992.  ANZFA also initiated a voluntary withdrawal of imported European beef and beef-based products from distribution and retail outlets. ANZFA (now Food Standards Australia New Zealand, FSANZ) raised a proposal in January 2001 to examine the risk of contracting vCJD from BSE-contaminated beef and beef products. Consequently, an emergency regulatory measure was introduced, under section 37 of the Australia New Zealand Food Authority Act 199. Volume 1 and volume 2 of the Australia New Zealand Food Standards Code were amended to require bovine meat and bovine-derived food ingredients in the Australian food supply to be derived from animals free from BSE. This amendment did not include milk and dairy products, gelatine, fats and tallow, collagen from bovine skins and hides, and non-beef flavourings.

A comprehensive risk assessment has been undertaken, in consultation with national and international experts, to examine the available scientific data and information to estimate the risks to human health from consumption of beef and beef products containing the BSE agent.   This assessment was released by FSANZ in August 2002. Based on this risk assessment, FSANZ recommends a refinement of the emergency measure to require bulk tallow and bone-derived gelatine to be derived from cattle free from BSE.

There have been approximately 131 cases of vCJD diagnosed worldwide to date, a very small number relative to the large number of people likely to have been exposed to the BSE agent in food. Although these numbers are relatively small, a number of factors must be considered in developing appropriate risk management options to protect public health and safety:

• There is no treatment for vCJD, i.e. the disease is fatal;
• There is no test for detection of the BSE agent in beef and processed beef products;
• The amount of the BSE agent required to be consumed to lead to the development of vCJD is unknown, however there are indications that a single exposure to the agent is sufficient to cause disease in cattle;
• The BSE agent is resistant to most treatments that destroy bacteria and viruses and therefore if the agent is present in raw meat, it will be present in the processed product at a similar level of infectivity; and
• There is evidence of inadequate compliance with control measures for significant reduction in the exposure risk to the BSE agent by a number of countries with BSE cases in their cattle populations.

In some circumstances, Australia has an obligation to notify the WTO of changes to food standards to enable other member countries of the WTO to make comment. 

Australia notified the WTO in July 2001 of the emergency measure that had been implemented and again in November 2001 when the permanent measure was implemented.

This proposal was progressed as an urgent proposal under s37 of the Australia New Zealand Food Authority Act 1991, and will be finalized in accordance with the provisions of the Food Standards Australia New Zealand Act 1991. Following this Pre-Final Assessment report, FSANZ will conduct a Final Assessment of P238.

Statement of Reasons

Food Standards Australia New Zealand recommends a refinement to its emergency measure for the following reasons:

• Regulation is required to protect public health and safety from the potentially severe consequences resulting from exposure to the BSE agent via food consumption. The proposed amendment to the Food Standards Code is consistent with the section 10 objectives of the Food Standards Australia New Zealand Act 1991.

• The Risk Assessment examining the risk of contracting vCJD as a consequence of exposure to the BSE agent through consumption of beef and beef products concluded that:

• different beef products pose a different level of risk of transmitting the BSE agent to humans. However cross-contamination of meat with the BSE agent during animal slaughter and the inability to inactivate the BSE agent during cooking must be considered in determining this level of risk;

•  The BSE agent has not been detected in milk and dairy products and thus pose a negligible risk;

•  Collagen presents a negligible risk of transmitting the BSE agent;
  
• Food-grade gelatine that has been produced from porcine skins and bovine hides is considered to pose a negligible risk to consumers. Where gelatine is derived from bones using a process that includes a sodium hydroxide step, the risk has also been shown to be negligible. However gelatine manufactured from bones where there is not a sodium hydroxide step results in a higher level of risk.

•  The current use of edible tallows by the food industry as an ingredient in products such as cakes, biscuits and pastries is estimated to pose a negligible risk of transmission of the BSE agent.

• The benefits of maintaining the current standard but amending the exemptions to restrict imports of bulk tallow and bone-derived gelatine far outweigh the costs of compliance and enforcement. 

These benefits include minimising the likelihood that the Australian population would be exposed to a fatal, food-borne illness and maintaining consumer confidence in the safety of imported beef and beef products.

Full Report [ pdf  857 kb ]