Infection with Brucella abortus, B. melitensis and B. suis

Article 8.4.1.

General provisions

1. The aim of this chapter is to mitigate the risk of spread of, and the risk to human health from, Brucella abortus, B. melitensis and B. suis in animals.

2. For the purpose of this chapter:

   1. 'Brucella' means B. abortus, B. melitensis or B. suis, excluding vaccine strains.

   2. 'Animals' means domestic and captive wild animal populations of the following categories:

      1. bovids: this term means cattle (Bos taurus, B. indicus, B. frontalis, B. javanicus and B. grunniens), bison (Bison bison and B. bonasus) and water buffalo (Bubalus bubalis);

      2. sheep (Ovis aries) and goats (Capra aegagrus);

      3. pigs (Sus scrofa);

      4. camelids: this term means dromedary camel (Camelus dromedarius), Bactrian camel (Camelus bactrianus), llama (Lama glama), alpaca (Lama pacos), guanaco (Lama guanicoe) and vicuna (Vicugna vicugna);

      5. cervids: this term means roe deer (Capreolus capreolus), red deer (Cervus elaphus elaphus), wapiti/elk (C. elaphus canadensis), sika (C. nippon), samba (C. unicolor unicolor), rusa (C. timorensis), fallow deer (Dama dama), white-tailed, black-tailed, mule deer (Odocoileus spp.) and reindeer/caribou (Rangifer tarandus);

      6. European hare (Lepus europaeus).

3. For the purpose of the Terrestrial Code, a case is an animal infected with Brucella.

4. The chapter deals not only with the occurrence of clinical signs caused by infection with Brucella, but also with the presence of infection with Brucella in the absence of clinical signs.

5. The following defines infection with Brucella:

   1. Brucella has been isolated from a sample from an animal;

   OR

   2. positive results to a diagnostic test have been obtained, and there is an epidemiological link to a case.

6. When authorising import or transit of commodities listed in this chapter, with the exception of those listed in Article 8.4.2., Veterinary Authorities should require the conditions prescribed in this chapter relevant to the Brucellainfection status of the animal population of the exporting country, zone, herd or flock.

7. Standards for diagnostic tests and vaccines are described in the Terrestrial Manual.

Article 8.4.2.

Safe commodities

When authorising import or transit of the following commodities, Veterinary Authorities should not require any Brucella-related conditions, regardless of the Brucellainfection status of the animal population of the exporting country:

1. skeletal muscle meat, brain and spinal cord, digestive tract, thymus, thyroid and parathyroid glands and derived products;

2. cured hides and skins;

3. gelatine, collagen, tallow and meat-and-bone meal.

Article 8.4.3.

Country or zone historically free from infection with Brucella in specified animal categories

A country or zone may be considered free from infection with Brucella in specified animal categories when:

1. infection with Brucella in animals is a notifiable disease in the entire country;

2. historical freedom in the relevant animal categories has been demonstrated as described in point 1 of Article 1.4.6.

Article 8.4.4.

Country or zone free from infection with Brucella in bovids without vaccination

1. To qualify as free from infection with Brucella in bovids without vaccination, a country or zone should satisfy the following requirements:

   1. infection with Brucella in animals is a notifiable disease in the entire country;

   2. no case has been recorded in bovids for at least the past three years;

   3. regular testing of all herds has been in place for the past three years; and this testing has demonstrated that during this period, infection with Brucella was not present in at least 99.8% of the herds representing at least 99.9% of bovids in the country or zone;

   4. regulatory measures have been implemented for the early detection of infection with Brucella in bovids, including at least the regular submission of samples from abortion cases to diagnostic laboratories;

   5. no bovids have been vaccinated against infection with Brucella for at least the past three years, and no bovids introduced into the country or zone have been vaccinated in the past three years;

   6. bovids and their genetic materials introduced into the country or zone comply with the recommendations in Articles 8.4.14. and 8.4.16. to 8.4.18.

2. To maintain the status as free from infection with Brucella in bovids without vaccination, a country or zone should satisfy the following requirements:

   1. the requirements in points 1a), 1b) and 1d) to 1f) above are met;

   2. a surveillance programme based on regular testing of bovids is in place in the country or zone to detect infection with Brucella in accordance with Article 1.4.4.;

   3. if the surveillance programme described in b) above has not detected infection with Brucella for two consecutive years, surveillance may be maintained in accordance with Article 1.4.5.

3. The country or zone status of free from infection with Brucella in bovids without vaccination is not affected by the occurrence of infection with Brucella in other animal categories or feral or wild animals provided that effective measures have been implemented to prevent transmission of infection with Brucella to bovids.

Article 8.4.5.

Country or zone free from infection with Brucella in bovids with vaccination

1. To qualify as free from infection with Brucella in bovids with vaccination, a country or zone should satisfy the following requirements:

   1. infection with Brucella in animals is a notifiable disease in the entire country;

   2. no case has been recorded in bovids for at least the past three years;

   3. regular testing of all herds has been in place for the past three years; and this testing has demonstrated that during this period, infection with Brucella was not present in at least 99.8% of the herds representing at least 99.9% of bovids in the country or zone;

   4. regulatory measures have been implemented for the early detection of infection with Brucella in bovids, including at least the regular submission of samples from abortion cases to diagnostic laboratories;

   5. vaccinated bovids should be permanently identified as such;

   6. bovids and their genetic materials introduced into the country or zone comply with the recommendations in Articles 8.4.14. and 8.4.16. to 8.4.18.

2. To maintain the status as free from infection with Brucella in bovids with vaccination, a country or zone should satisfy the following requirements:

   1. the requirements in points 1a), 1b) and 1d) to 1f) above are met;

   2. a surveillance programme based on regular testing of bovids is in place in the country or zone to detect infection with Brucella in accordance with Article 1.4.4.;

   3. if the surveillance programme described in b) above has not detected infection with Brucella for two consecutive years, surveillance may be maintained in accordance with Article 1.4.5.

3. The country or zone status of free from infection with Brucella in bovids with vaccination is not affected by the occurrence of infection with Brucella in other animal categories or feral or wild animals provided that effective measures have been implemented to prevent transmission of infection with Brucella to bovids.

4. The status of a country or zone free from infection with Brucella in bovids with vaccination remains unchanged for a period of three years after vaccination has ceased, provided that the requirements in points 1a), 1b) and 1d) to 1f) of Article 8.4.4. are met, at which time this status may be changed to free from infection with Brucella in bovids without vaccination.

Article 8.4.6.

Country or zone free from infection with Brucella in sheep and goats without vaccination

1. To qualify as free from infection with Brucella in sheep and goats without vaccination, a country or zone should satisfy the following requirements:

   1. infection with Brucella in animals is a notifiable disease in the entire country;

   2. no case has been recorded in sheep and goats for at least the past three years;

   3. regular testing of all flocks has been in place for the past three years; and this testing has demonstrated that during this period, infection with Brucella was not present in at least 99.8% of the flocks representing at least 99.9% of sheep and goats in the country or zone;

   4. regulatory measures have been implemented for the early detection of infection with Brucella in sheep and goats, including at least the regular submission of samples from abortion cases to diagnostic laboratories;

   5. no sheep and goats have been vaccinated against infection with Brucella for at least the past three years and no sheep and goats introduced into the country or zone have been vaccinated in the past three years;

   6. sheep and goats and their genetic materials introduced into the country or zone comply with the recommendations in Articles 8.4.14. and 8.4.16. to 8.4.18.

2. To maintain the status as free from infection with Brucella in sheep and goats without vaccination, a country or zone should satisfy the following requirements:

   1. the requirements in points 1a), 1b) and 1d) to 1f) above are met;

   2. a surveillance programme based on regular testing of sheep and goats is in place in the country or zone to detect infection with Brucella in accordance with Article 1.4.4.;

   3. if the surveillance programme described in b) above has not detected infection with Brucella for two consecutive years, surveillance may be maintained in accordance with Article 1.4.5.

3. The country or zone status of free from infection with Brucella in sheep and goats without vaccination is not affected by the occurrence of infection with Brucella in other animal categories or feral or wild animals provided that effective measures have been implemented to prevent transmission of infection with Brucella to sheep and goats.

Article 8.4.7.

Country or zone free from infection with Brucella in sheep and goats with vaccination

1. To qualify as free from infection with Brucella in sheep and goats with vaccination, a country or zone should satisfy the following requirements:

   1. infection with Brucella in animals is a notifiable disease in the entire country;

   2. no case has been recorded in sheep and goats for at least the past three years;

   3. regular testing of all flocks has been in place for the past three years; and this testing has demonstrated that during this period, infection with Brucella was not present in at least 99.8% of the flocks representing at least 99.9% of sheep and goats in the country or zone;

   4. regulatory measures have been implemented for the early detection of infection with Brucella in sheep and goats, including at least the regular submission of samples from abortion cases to diagnostic laboratories;

   5. vaccinated sheep and goats should be permanently identified as such;

   6. sheep and goats and their genetic materials introduced into the country or zone comply with the recommendations in Articles 8.4.14. and 8.4.16. to 8.4.18.

2. To maintain the status as free from infection with Brucella in sheep and goats with vaccination, a country or zone should satisfy the following requirements:

   1. the requirements in points 1a), 1b) and 1d) to 1f) above are met;

   2. a surveillance programme based on regular testing of sheep and goats is in place in the country or zone to detect infection with Brucella in accordance with Article 1.4.4.;

   3. if the surveillance programme described in b) above has not detected infection with Brucella for two consecutive years, surveillance may be maintained in accordance with Article 1.4.5.

3. The country or zone status of free from infection with Brucella in sheep and goats with vaccination is not affected by the occurrence of infection with Brucella in other animal categories or feral or wild animals provided that effective measures have been implemented to prevent transmission of infection with Brucella to sheep and goats.

4. The status of a country or zone free from infection with Brucella in sheep and goats with vaccination remains unchanged for a period of three years after vaccination has ceased, provided that the requirements in points 1a), 1b) and 1d) to 1f) of Article 8.4.6. are met, at which time this status may be changed to free from infection with Brucella in sheep and goats without vaccination.

Article 8.4.8.

Country or zone free from infection with Brucella in camelids

1. To qualify as free from infection with Brucella in camelids, a country or zone should satisfy the following requirements:
   

   1. infection with Brucella in animals is a notifiable disease in the entire country;
      

   2. no case has been recorded in camelids for at least the past three years;
      

   3. regular testing of all herds has been in place for the past three years; and this testing has demonstrated that during this period, infection with Brucella was not present in at least 99.8% of the herds representing at least 99.9% of camelids in the country or zone;

   4. regulatory measures have been implemented for the early detection of infection with Brucella in camelids, including at least the regular submission of samples of abortion cases to diagnostic laboratories;

   5. no camelids have been vaccinated against infection with Brucella for at least the past three years and no camelids introduced into the country or zone have been vaccinated in the past three years;

   6. camelids and their genetic materials introduced into the country or zone comply with the recommendations in Articles 8.4.14. and 8.4.16. to 8.4.18.

2. To maintain the status as free from infection with Brucella in camelids, a country or zone should satisfy the following requirements:

   1. the requirements in points 1a), 1b) and 1d) to 1f) above are met;

   2. a surveillance programme based on regular testing of camelids is in place in the country or zone to detect infection with Brucella in accordance with Article 1.4.4.;

   3. if the surveillance programme described in b) above has not detected infection with Brucella for two consecutive years, surveillance may be maintained in accordance with Article 1.4.5.

3. The country or zone status of free from infection with Brucella in camelids is not affected by the occurrence of infection with Brucella in other animal categories or feral or wild animals provided that effective measures have been implemented to prevent transmission of infection with Brucella to camelids.

Article 8.4.9.

Country or zone free from infection with Brucella in cervids

1. To qualify as free from infection with Brucella in cervids, a country or zone should satisfy the following requirements:

   1. infection with Brucella in animals is a notifiable disease in the entire country;

   2. no case has been recorded in cervids for at least the past three years;

   3. regular testing of all herds has been in place for the past three years; and this testing has demonstrated that during this period, infection with Brucella was not present in at least 99.8% of the herds representing at least 99.9% of cervids in the country or zone;

   4. regulatory measures have been implemented for the early detection of infection with Brucella in cervids, including at least the regular submission of samples from abortion cases to diagnostic laboratories;

   5. no cervids have been vaccinated against infection with Brucella for at least the past three years and no cervids introduced into the country or zone have been vaccinated in the past three years;

   6. cervids and their genetic materials introduced into the country or zone comply with the recommendations in Articles 8.4.14. and 8.4.16. to 8.4.18.

2. To maintain the status as free from infection with Brucella in cervids, a country or zone should satisfy the following requirements:

   1. the requirements in points 1a), 1b) and 1d) to 1f) above are met;

   2. a surveillance programme based on regular testing of cervids is in place in the country or zone to detect infection with Brucella in accordance with Article 1.4.4.;

   3. if the surveillance programme described in b) above has not detected infection with Brucella for two consecutive years, surveillance may be maintained in accordance with Article 1.4.5.

3. The country or zone status of free from infection with Brucella in cervids is not affected by the occurrence of infection with Brucella in other animal categories or feral or wild animals provided that effective measures have been implemented to prevent transmission of infection with Brucella to cervids.

Article 8.4.10.

Herd or flock free from infection with Brucella in bovids, sheep and goats, camelids or cervids without vaccination

1. To qualify as free from infection with Brucella without vaccination, a herd or flock of bovids, sheep and goats, camelids or cervids should satisfy the following requirements:

   1. the herd or flock is in a country or zone free from infection with Brucella without vaccination in the relevant animal category and is certified free without vaccination by the Veterinary Authority;

   OR

   2. the herd or flock is in a country or zone free from infection with Brucella with vaccination in the relevant animal category and is certified free without vaccination by the Veterinary Authority; and no animal of the herd or flock has been vaccinated in the past three years;

   OR

   3. the herd or flock met the following conditions:

      1. infection with Brucella in animals is a notifiable disease in the entire country;

      2. no animal of the relevant category of the herd or flock has been vaccinated in the past three years;

      3. no case has been detected in the herd or flock for at least the past year;

      4. animals showing clinical signs consistent with infection with Brucella such as abortions have been subjected to the necessary diagnostic tests with negative results;

      5. for at least the past year, there has been no evidence of infection with Brucella in other herds or flocks of the same establishment, or measures have been implemented to prevent any transmission of the infection with Brucella from these other herds or flocks;

      6. two tests have been performed with negative results on all sexually mature animals present in the herd at the time of testing, the first test being performed not before 3 months after the slaughter of the last case and the second test at an interval of more than 6 and less than 12 months.

2. To maintain the free status, the following conditions should be met:

   1. the requirements in points 1a) or 1b) or 1c)i) to v) above are met;

   2. regular tests, at a frequency depending on the prevalence of herd or flockinfection in the country or zone, demonstrate the continuing absence of infection with Brucella;

   3. animals of the relevant category introduced into the herd or flock are accompanied by a certificate from an Official Veterinarian attesting that they come from:

      1. a country or zone free from infection with Brucella in the relevant category without vaccination;

      OR

      2. a country or zone free from infection with Brucella with vaccination and the animals of the relevant category have not been vaccinated in the past three years;

      OR

      3. a herd or flock free from infection with Brucella with or without vaccination and that the animals have not been vaccinated in the past three years and were tested for infection with Brucella within 30 days prior to shipment with negative results; in the case of post-parturient females, the test is carried out at least 30 days after giving birth. This test is not required for sexually immature animals.

Article 8.4.11.

Herd or flock free from infection with Brucella in bovids, sheep and goats with vaccination

1. To qualify as free from infection with Brucella with vaccination, a herd of bovids or flock of sheep and goats should satisfy the following requirements:

   1. the herd or flock is in a country or zone free from infection with Brucella with vaccination for the relevant animal category and is certified free with vaccination by the Veterinary Authority;

   OR

   2. the herd or flock met the following conditions:

      1. infection with Brucella in animals is a notifiable disease in the entire country;

      2. vaccinated animals of the relevant categories are permanently identified as such;

      3. no case has been detected in the herd or flock for at least the past year;

      4. animals showing clinical signs consistent with infection with Brucella such as abortions have been subjected to the necessary diagnostic tests with negative results;

      5. for at least the past year, there has been no evidence of infection with Brucella in other herds or flocks of the same establishment, or measures have been implemented to prevent any transmission of the infection with Brucella from these other herds or flocks;

      6. two tests have been performed with negative results on all sexually mature animals present in the herd at the time of testing, the first test being performed not before 3 months after the slaughter of the last case and the second test at an interval of more than 6 and less than 12 months.

2. To maintain the free status, the following conditions should be met:

   1. the requirements in points 1 a) or 1b)i) to v) above are met;

   2. regular tests, at a frequency depending on the prevalence of herd or flockinfection in the country or zone, demonstrate the continuing absence of infection with Brucella;

   3. animals of the relevant category introduced into the herd or flock should be accompanied by a certificate from an Official Veterinarian attesting that they come from either:

      1. a country or zone free from infection with Brucella in the relevant category with or without vaccination;

      OR

      2. a herd or flock free from infection with Brucella with or without vaccination and that the animals were tested for infection with Brucella within 30 days prior to shipment with negative results; in the case of post-parturient females, the test is carried out at least 30 days after giving birth. This test is not required for sexually immature animals or vaccinated animals less than 18 months of age.

Article 8.4.12.

Herd free from infection with Brucella in pigs

1. To qualify as free from infection with Brucella, a herd of pigs should satisfy the following requirements:

   1. infection with Brucella in animals is a notifiable disease in the entire country;

   2. no case has been detected in the herd for at least the past three years;

   3. animals showing clinical signs consistent with infection with Brucella such as abortions or orchitis have been subjected to the necessary diagnostic tests with negative results;

   4. no pigs of the herd have been vaccinated for at least the past three years and no pigs introduced into the herd have been vaccinated in the past three years;

   5. for at least the past three years, there has been no evidence of infection with Brucella in other herds or flocks of the same establishment, or measures have been implemented to prevent any transmission of infection with Brucella from these other herds or flocks.

2. To maintain the free status, the following conditions should be met:

   1. the requirements in point 1 above are met;

   2. animals introduced into the herd are accompanied by a certificate from an Official Veterinarian attesting that:

      1. they come from a herd free from infection with Brucella;

      OR

      2. they come from a herd in which a statistically valid sample of the breeding pigs, selected in accordance with Article 1.4.4., was tested within 30 days prior to shipment, demonstrating the absence of infection with Brucella;

      OR

      3. they were tested within 30 days prior to shipment with negative results.

Article 8.4.13.

Recovery of the Brucella infection free status in a country or a zone

Should a case of infection with Brucella in one or more animal categories occur in a free country or zone as described in Articles 8.4.4. to 8.4.9., the free status may be recovered once the following requirements are met:

1. all infected animals of the relevant category have been slaughtered or destroyed as soon as infection with Brucella is confirmed;

2. an epidemiological investigation has been performed within 60 days of confirmation of infection with Brucella in the herd or flock, aiming at identifying the likely source and the distribution of the infection, and shows that the number of outbreaks is limited and all are epidemiologically linked;

3. in the index herd or flock and herds or flocks identified by the epidemiological investigation:

   1. whole herd or flock depopulation has been practised; or

   2. whole herd or flock depopulation has not been practised, and all remaining sexually mature animals except castrated males have been tested, with negative results, on three occasions, at an interval of not less than two months, then a fourth test six months later and a final fifth test a year later;

   and

   3. no animals are moved from the herds or flocks except directly for slaughter until the processes in point a) or b) above are completed;

4. cleansing and disinfection procedures have been applied at the end of the slaughter process and before new animals are introduced.

If these requirements have not been met, the status is not recovered and Articles 8.4.4. to 8.4.9. apply as relevant.

Article 8.4.14.

Recommendations for the importation of bovids, sheep and goats, camelids or cervids for breeding or rearing

Veterinary Authorities of importing countries should require the presentation of an international veterinary certificate attesting that the animals of the relevant category:

1. showed no clinical sign of infection with Brucella on the day of shipment;

2. originate from:

   1. a country or zone free from infection with Brucella as relevant;

   OR

   2. a herd or flock free from infection with Brucella and all sexually mature animals were tested for infection with Brucella with negative results within 30 days prior to shipment;

   OR

   3. a herd or flock not qualified free from infection with Brucella:

      1. in which no case has been reported during the year prior to shipment;

      2. the animals were isolated for 30 days prior to shipment and all animals in isolation were tested for infection with Brucella within that period with negative results; in the case of post-parturient females, the test was carried out at least 30 days after giving birth.

Article 8.4.15.

Recommendations for the importation of pigs for breeding or rearing

Veterinary Authorities of importing countries should require the presentation of an international veterinary certificate attesting that the pigs:

1. showed no clinical sign of infection with Brucella on the day of shipment;

2. either

   1. originate from a herd free from infection with Brucella;

   OR

   2. originate from a herd in which a statistically valid sample of the breeding pigs, selected in accordance with Article 1.4.4., was tested within 30 days prior to shipment, demonstrating the absence of infection with Brucella;

   OR

   3. were isolated for 30 days prior to shipment and all pigs in isolation were tested for infection with Brucella within that period with negative results.

Article 8.4.16.

Recommendations for the importation of animals for slaughter

Veterinary Authorities of importing countries should require the presentation of an international veterinary certificate attesting that the animals:

1. showed no clinical sign of infection with Brucella on the day of shipment;

2. originate from a country, zone, herd or flock free from infection with Brucella;

OR

3. are not being culled as part of an eradication programme against Brucellainfection and in the case of sexually mature bovids, sheep and goats, camelids or cervids, were tested for infection with Brucella with negative results within 30 days prior to shipment.

Article 8.4.17.

Recommendations for the importation of semen

Veterinary Authorities of importing countries should require the presentation of an international veterinary certificate attesting that:

1. the donor animals showed no clinical sign of infection with Brucella on the day of collection of the semen;

2. the donor animals were not vaccinated against infection with Brucella and either:

   1. were kept in an artificial insemination centre complying with Chapter 4.5. and the semen was collected and processed in accordance with Chapter 4.6.;

   OR

   2. were kept in a herd or flock free from infection with Brucella and tested every six months for infection with Brucella with negative results, and the semen was collected, processed and stored in accordance with Articles 4.5.3. to 4.5.5. and Articles 4.6.5. to 4.6.7.

Article 8.4.18.

Recommendations for the importation of embryos

Veterinary Authorities of importing countries should require the presentation of an international veterinary certificate attesting that:

1. the donor animals showed no clinical signs of infection with Brucella on the day of collection;

2. the donor animals were not vaccinated against infection with Brucella in the past three years and either:

   1. were kept in a country or zone free from infection with Brucella, as relevant;

   OR

   2. were kept in a herd or flock free from infection with Brucella and tested every six months for infection with Brucella with negative results;

3. the embryos were collected, processed and stored in accordance with Chapters 4.7. to 4.9.

Article 8.4.19.

Recommendations for the importation of fresh meat and meat products other than mentioned in Article 8.4.2.

Veterinary Authorities of importing countries should require the presentation of an international veterinary certificate attesting that the meat and meat products come from animals:

1. which have been subjected to ante-and post-mortem inspections as described in Chapter 6.2.;

2. which:

   1. originate from a country or zone free from infection with Brucella, as relevant;

   OR

   2. originate from a herd or flock free from infection with Brucella;

   OR

   3. have not been culled as part of an eradication programme against infection with Brucella.

Article 8.4.20.

Recommendations for the importation of milk and milk products

Veterinary Authorities of importing countries should require the presentation of an international veterinary certificate attesting that the milk or the milk products:

1. have been derived from animals in a country, zone, herd or flock free from infection with Brucella as relevant;

OR

2. were subjected to pasteurisation or any combination of control measures with equivalent performance as described in the Codex Alimentarius Code of Hygienic Practice for Milk and Milk Products.

Article 8.4.21.

Recommendations for importation of wool and hair

Veterinary Authorities of importing countries should require the presentation of an international veterinary certificate attesting that these products:

1. have not been derived from animals culled as part of an eradication programme against infection with Brucella;

OR

2. have been processed to ensure the destruction of Brucella.