18 July 2001

BOVINE SPONGIFORM ENCEPHALOPATHY (BSE): HUMAN HEALTH REQUIREMENTS FOR THE IMPORTATION OF BEEF AND BEEF PRODUCTS

Purpose

To describe the requirements designed to manage the human health risk of developing variant Creutzfeldt-Jakob disease (vCJD) from exposure tobeef and/or beef productsinfected with Bovine Spongiform Encephalopathy (BSE) agent. These requirements are in addition to existing sanitary measures.

Summary

In response to an increasing number ofcasesof Bovine Spongiform Encephalopathy (BSE) being reported in Europe, certification requirements have been developed to ensure that importedbeef and beef productsare safe for human consumption.

The certification shall be issued by the relevantCompetent National Government Authorityin accordance with the BSE-risk categorisation for the exporting each country/zone. The following products are exempt from these requirements:

-                                    collagen from bovine skins and hides (including sausage casings produced from this type of collagen)

-                                    fats and tallow which contain a maximum level of insoluble impurities of 0.15% in weight, and derivatives made from this tallow

-                                    gelatine from hides and skins

-                                    milk and other dairy products.

The European Commission (EC) has already undertaken a categorisation of the risk level presented by some beef-exporting countries. This assessment, known as the Geographical BSE Risk (GBR) assessment, assigns a country to a category. The GBR assessment process has been examined by ANZFA, which considers it an appropriate instrument to inform the mechanism for assessing whether the beef and beef products from the country concerned represents a risk to the health of Australian consumers.   Australian importation requirements forbeef and beef productsuse these GBR assessments as one way to categorise countries.   Australia reserves the right to validate these GBR assessments.

Definitions

A Category A risk country or zone

is one in which:

EITHER

The European Commission (EC) has conducted a GBR assessment and classified the country or zone as level I or II.

OR

A risk analysis as described in the OIE International Animal Health Code 2000 (Article 2.3.13.1. point 1) has been conducted by Australia and has shown that all potential risk factors for BSE have been addressed by the implementation of appropriate measures for the relevant period of time, no BSEcaseshave been reported, and

either

the criteria in Article 2.3.13.1 points 2) to 5) have been met;

or

BSE is compulsorily notifiable and the ban on feeding ruminant-derivedmeat

 mealto ruminants has been enforced for at least 8 years.

OR

The country complies with Article 2.3.13.2 of the OIE International Animal Health Code (2000).

A Category B risk country or zone

is one in which

no BSEcasesexist or have been reported but the country or zone does not meet category A, C or D criteria.

A Category C risk country or zone

is one in which the European Commission (EC) has conducted a GBR assessment and classified the country at Level III (likely but not confirmed) or has been so categorised following a risk assessment carried out by Australian authorities in accordance with OIE requirements.

OR

One or more BSEcaseshave been previously reported, but Australia has satisfied itself, on scientific grounds, that it is safe to import beef products from the country or zone in question following an appropriate review of process.   There would be a requirement of evidence of compliance for at least two years with the measures specified as category C.

A Category D risk country or zone

is one which has reported one or more indigenouscasesof BSE to the OIE, or ANZFA is satisfied that the country or zone has had one or more indigenouscasesof BSE. Countries which have been assessed by the EC and assigned as GBR Category IV or Category III (confirmed, but at a lower level) fall intoCategory D.

The suspension of imports will be continued.

Ante- and post-mortem veterinary inspection

Means the inspection by a Veterinarian authorised by theCompetent National Government Authorityprior to and following slaughter at an abattoir.

Beef and beef products

Products which contain bovine tissue (including cattle, buffalo and bison). This includes meat, bone and offal but excludes milk, dairy products, gelatine, collagen, rendered fats, tallow and dicalcium phosphate.

BSE risk materials

·                                Specified risk materials which are: the skull, brains, eyes, the tonsils, vertebral column and spinal cord, including dorsal root ganglia, of bovine animals aged over 12 months; and the intestines from the duodenum to the rectum of bovine animals of all ages.

·                                Mechanically recovered meat

·                                Beef and/or beef productsfrom animals killed after stunning by means of a gas injected into the cranial cavity or killed instantaneously by the same method, or slaughtered by laceration of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity (pithing).

Case

Means an indigenous bovine animal affected by BSE and confirmed by histological techniques or other officially recognised tests.

Competent National Government Authority

That Authority recognised by Australia that can certify compliance with animal health and sanitary measures contained in these certification requirements. This would usually (but not always) be the government veterinary administration.

High risk factors

Means bovine animals imported from countries or zones categorised as B, C or D and/or the feeding ofmeat mealto bovine animals.

Meat meal

Means any ruminant-derived by-product of the meat trade consisting of meat, bone and other tissue.

Categorisation of Countries

Countries will be categorised asCategory A, B, C or D risk countries or zonesupon application to import beef and beef products to Australia.

Applications for categorisation may be made to Australia and must be accompanied by documentation to confirm their proposed status. This documentation must include details of auditing systems in place to monitor compliance with risk management measures, feeding restrictions and traceback systems. Countries can request a review of their categorisation. The review of country categorisation could comprise a number of actions including an audit of the systems.   Australia can also initiate a review of country status.

CERTIFICATION

General Requirements

Official certificates will only be considered by Australian authorities if supplied by the agreedCompetent National Government Authorityin each country.

Certificates must be in the form and manner of the wording agreed between Australia and the exporting country.

The official certificates must:

·                                clearly identify the certifying body,

·                                be uniquely numbered,

·                                be in the English language,

·                                be designed to minimise fraud,

·                                identify theCompetent National Government Authority

·                                be dated, stamped and signed by the officer/s appointed by theCompetent National Government Authorityand responsible for supervising the process or production and verification of compliance with requirements;

·                                clearly identify the commodity and consignment to which they relates.

Official certificates may be accepted if issued retrospectively by theCompetent National Government Authorityproviding they comply with the above criteria.

Specific Requirements

Each consignment ofbeef and/or beef productswill only be considered safe for importation when accompanied by an official certificate with the following attestations dependent on thecountry s or zone srisk status as determined by Australia.

1. Category A risk countriesorzones

Thebeef and/or beef productis derived from bovine animals [1] that have been born, raised and slaughtered inCategory A risk countriesorzones(see definition).

OR

2.Category Brisk countriesorzones

The beef and/or beef product is derived from bovine animals¹ that have lived in Category B risk countries or zones (see definition) where the feeding of ruminant-derived meat meal to bovine animals is banned and

i)         there has not been exposure to high risk factors ,

ii)        ante- and post-mortem veterinary inspection is carried out on all bovine animals, and

iii)     the product does not contain, and is not derived from,  BSE risk materials.

OR

3.Category C risk countriesorzones

Thebeef and/or beef productis derived from bovine animals¹ that have lived inCategory C risk countriesorzones(see definitions) and that satisfies the following criteria:

i)         animals affected by BSE and, for females, their last progeny born within 2 years prior to or after the onset of clinical symptoms, were slaughtered and completely destroyed; and

ii)        the feeding of ruminant-derivedmeat mealto bovine animals is banned; and

iii)      ante- and post-mortem veterinary inspectionis carried out on all bovine animals; and

iv)       the bovine animals from which thebeef and/or beef productoriginates:

·                                were 30 months of age or younger at slaughter;

·                                were permanently identified enabling them to be traced back to the dam and herd of origin;

·                                were not the progeny of BSE suspect or confirmed females; and

either

were born after the date of the ban on feeding ruminant-derivedmeat mealto bovine animals;

or

were born and remained in herds in which nocaseof BSE had been confirmed during the preceding seven years; and

v)        thebeef and/or beef productdoes not contain, and is not derived from,  BSE risk materials, and

vi)       a system is in operation enabling thebeef and/or beef productto be traced back to the abattoir and animals from which it was derived, and

vii)         verifiable means exist for assessing compliance.