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Published in the Official Gazette of August 28, 2007, Section 1, Page 6

Establishes the conditions for the vaccination of cattle females against brucellosis with a RB51 sample vaccine.

THE MINISTRY OF AGRICULTURE, LIVESTOCK HEALTH AND FOOD SUPPLY’S AGRICULTURE AND LIVESTOCK AND INSPECTION SECRETARY, by virtue of the powers vested in him under Arts. 9 and 42, Annex I of Decree No. 5351 of January 21, 2005, having in view the provisions under Decree No.

24548 of July 3, 1934; SDA Normative Instruction No. 6, of January 8, 2004; and Proceeding No.

21000.004860/2005-13, RESOLVES:

Art. 1. To set forth the conditions for the vac-cination of cattle females against brucellosis with a RB51 sample vaccine.

Art. 2. The vaccination of female cattle with a RB51 sample vaccine shall be recommended in the following cases:

I – Females aged over eight months that have not been vaccinated with B19 sample be-tween three and eight months of age; or

II – Adult females that do not react to diag-nostic tests on rearing establishments with bru-cellosis outbreak.

Art. 3. The vaccination referred to in the preceding Art. shall be performed under the re-sponsibility of a veterinary doctor registered with the Official Veterinary Service of the state as the case may be.

Art. 4. The use of a RB51 sample vaccine

against brucellosis on male cattle of any age, on females aged up to eight months, and on preg-nant females is hereby prohibited.

Art. 5. The marketing of the RB51 sample vaccine against brucellosis may be done solely by duly registered and authorized commercial establishments and shall be subject to the official service’s inspection.

Paragraph 1. Acquisition of the vaccine shall be permitted solely against a pertinent prescrip-tion, pursuant to the form shown in Annex I hereto, issued by a veterinary doctor registered with the official and Inspection service of the per-tinent state.

Paragraph 2. The veterinary doctor’s pre-scription shall be kept by the commercial estab-lishment and shall include the veterinary doctor’s full name and signature, his registration number with the Veterinary Medicine Council (CRMV), his registration number with the official and Inspec-tion service, as the case may be, the number of doses to be purchased, and the place and date.

Art. 6. The commercial establishment shall apprise the official service of the purchase, sale, and stock of the RB51 sample vaccine, as pre-scribed under Annex II hereto.

Art. 7. The veterinary doctor responsible for the vaccination shall issue a vaccination

cer-101 tificate in three copies, of which the first shall

be kept by the owner, the second by the local unit of the official service of the state as the case may be, and the third by the issuer, as

pre-scribed under Annex III or Annex IV hereunder, as the case may be.

Art. 8. This Normative Instruction shall enter into force on the date of its publication.

INÁCIO AFONSO KROETZ

ANNEX I

Veterinary doctor’s name:

No. of registration with the state’s official service:

No. of registration with the Veterinary Medicine Council (CRMV):

Address:

Phone:

Vaccine: RB51 sample

Quantity of doses ___________ ( _______________________ ).

Place and date

Veterinary doctor’s signature and seal

PRESCRIPTION FOR THE PURCHASE OF RB51 SAMPLE VACCINES

102

OBSERVATIONS:

Place and date:

Name and signature of the person in charge:

ANNEX II

REPORT ON THE MARKETING OF RB51 SAMPLE VACCINE AGAINST BRUCELLOSIS

Commercial establishment:

Address and telephone: Municipality: State:

Period covered:

Date Laboratory Lot No. vials No. doses Expiration

PURCHASE:

SALE:

Veterinarian’s name and registration nº.

Laboratory Lot No. vials No.

doses

Expiration

CURRENT STOCK:

Date Laboratory Lot No. vials No. doses Expiration

103 ANNEX III

CERTIFICATE OF VACCINATION AGAINST BRUCELLOSIS RB51 SAMPLE VACCINE

I hereby certify that ______ (________________) females were vaccinated against brucellosis on ____________’s property known as _______________________, registered with the official state service under No._____________ and located in the Municipality of _____________________________, in the state of _______________________________.

The vaccine used was the RB51 sample vaccine produced by the _____________ laboratory, lot No. ______, manufactured on ___________________, and valid until ______________.

Place and date of vaccination

Veterinary Doctor

CRMV Registration No.___________________ and No. of registration with the state official health and inspection service ___________________

104

ANNEX IV

CERTIFICATE OF VACCINATION AGAINST BRUCELLOSIS RB51 SAMPLE VACCINE

(Form to be used in connection with the vaccination of individually identified females under an appropriate system prescribed by MAPA)

OWNER:

PROPERTY’S NAME:

No. OF REGISTRATION WITH THE OFFICIAL AND INSPECTION SERVICE:

MUNICIPALITY: STATE.:

I hereby certify for the pertinent purposes that the females listed below have been vaccinated against brucellosis with the RB51 sample vaccine, lot nº. manufactured by the laboratory on and with expiration date . (Females listed by number, name, age, and breed)

1.

2.

3.

4.

5.

6.

7.

Place and date of vaccination

Veterinary Doctor

CRMV Registration nº. ____________ and nº. of registration with the state official and Inspection service ___________________

105 The accreditation and monitoring of bovine

and bubaline brucellosis diagnostic laboratories shall be based on this Normative Instruction as well as on SDA Normative Instruction No. 51 of June 27, 2003; SDA Normative Instruction No. 6 of January 8, 2004; and any acts that may eventu-ally replace them.

1. OBJECTIVES:

1.1. To standardize the procedures adopted by bovine and bubaline brucellosis diagnostic laboratories; and

1.2. To accredit laboratories provided with a quality guarantee system, in support of animal health and Inspection actions determined by the Ministry of Agriculture, Livestock, and Food Supply-MAPA.

2. APPLICATION

2.1. This Normative Instruction applies to public and private laboratories interested in join-ing the Agriculture and Livestock Health Care Uni-fied System’s National Network of Agriculture and Livestock Laboratories in connection with bovine and bubaline brucellosis diagnostic, provided

they have a veterinary doctor responsible for the technical area as well as a quality control system.

3. DEFINITIONS

3.1. For the purposes hereunder, the follow definitions shall apply:

3.1.1. Official Health and Inspection Service:

service under the Central and Superior Organ and the Intermediate and Local Organs charged with the promotion of animal health and the preven-tion, control, and eradication of diseases that may harm animal productivity, the economy, and agriculture and livestock health.

3.1.2. Official veterinary doctor: government Health and Inspection service veterinary doctor.

3.13. Accredited veterinary doctor: a private sector professional qualified before one of the Agriculture and Livestock Health Care Unified System’s three Organs to carry out specific animal health and Inspection actions as determined by the Ministry of Agriculture, Livestock, and Food Supply as Central and Superior Organ.

3.1.4. Owner: any legal or natural person that owns one or more than one cattle and buffalo.