1997 Decree on the use of sera and vaccines

Distribution date: 18 November 1997
The Decree contains a prohibition to treat animals with live vaccines for contagious animal diseases without exemption granted by the Ministry of Agriculture, Nature Management and Fisheries (Section 2). Exemption shall only be granted for treatment with vaccines to be designated by the Minister. The prohibition shall not apply to the treatment of animals with a live vaccine designated by the Minister for animal diseases designated by the Minister (Section 2, fourth paragraph).The Decree also contains a prohibition to treat animals for specified animal diseases with inactivated vaccines and sera unless the Minister has allowed the use of specified inactivated vaccines and sera by an exemption (Section 3).Finally, the Decree provides specific criteria to be met by vaccines against Aujeszky's diseases (Section 5).
Products Covered: Veterinary medicinal products (8 pages)
Regulation Type: Regular notification
Substantial Evidence of Effectiveness of New Animal Drugs (available in English - 11 pages)

Distribution date: 18 November 1997
The Food and Drug Administration, as directed by the Animal Drug Availability Act of 1996 (ADAA), is proposing to amend its new animal drug regulations to further define the term "substantial evidence". The purpose of this proposed regulation is to encourage the submission of new animal drug applications (NADA's) and supplemental NADA's for single ingredient and combination new animal drugs. The proposal also encourages dose range labelling.
Products Covered: Animal drugs
Regulation Type: Regular notification
Amendment to the Animal Health Ordinance (4 pages, available in German, French and Italian)

Distribution date: 29 October 1997
The following organs or tissues may not be used for human food, animal feed, production of drugs;(a)brains, spinal cords, eyes, tonsils, thymus, spleens and intestines from bovines over 6 months;(b)brains, spinal cords, eyes, tonsils, thymus, and intestines from ovines and caprines over 6 months;(c)spleens of ovines and caprines regardless of their age.Heads and vertebrate columns of bovines, ovines and caprines of any age may not be used for the production of mechanically deboned meat.Mammalian fat to be used for the production of animal feed must be heat treated (133(C/20 min.).Mammalian bones to be used for the production of animal feed must be heat treated (133(C/3 bar/20 min.).
Products Covered: 0202, 0511, 1601, 1602, 2309, Chapter 30
Regulation Type: Regular notification
Food Control Act, 1993 - Draft Regulations (DP-11-1996) B - Raw and Pasteurized Cow's Milk Regulations (22 pages)

Distribution date: 29 October 1997
The proposed Draft Regulations apply to all raw and/or pasteurized cow's milk produced, manufactured, packaged, labelled, stored, transported, displayed, distributed, sold or traded in Botswana. The Regulations further lay out the provisions concerning: the issuance of permits; inspection of dairy farms and milk plants; sampling procedures; physical, chemical and microbiological requirements for raw and pasteurized milk; plants sanitation facilities and equipment.
Products Covered: Raw and pasteurized cow's milk
Regulation Type: Regular notification
Sanitary Requirements for Importing Animal Blood, Serum and Plasma for Use in Vitro into Chile (2 pages)

Distribution date: 06 October 1997
Conditions to be met by countries in order to export animal blood, serum and plasma for use in vitro to Chile.
Products Covered: Animal blood, serum and plasma for use in vitro
Regulation Type: Regular notification
Draft Mexican Official Standard NOM-055-ZOO-1995, Minimum Requirements for the Preparation of Vaccines Used in the Prevention, Control and Eradication of Avian Influenza (8 pages)

Distribution date: 30 September 1997
The purpose of this Mexican Official Standard is to standardize the minimum requirements for vaccines, antigens and reagents used in the prevention, control and eradication of avian influenza. It applies to such products whether locally produced or imported.
Products Covered: Vaccines, antigens and reagents
Regulation Type: Regular notification
Draft Amendment to Mexican Official Standard NOM-006-ZOO-1993. Biological Effectiveness Requirements for Ixodicides for Bovine Use and Test Methods (1 page)

Distribution date: 30 September 1997
This amendment to the Mexican Official Standard has been drawn up because in the present conditions of very high pyrethroid resistance, on the basis of the field evaluations submitted, organophosphates offer an alternative for the control of Haematobia irritans. The draft amendment therefore revises paragraph 4.4 of NOM-006-ZOO-1993 to read as follows:4.4As various fly-killers may have an acaricidal effect and be used for killing ticks, fly-killers must be evaluated at least by field tests carried out by an approved laboratory and have a demonstrated minimum effectiveness of 80 per cent.
Products Covered: Ixodicides for bovine use
Regulation Type: Regular notification
Draft Amendment to Mexican Official Standard NOM-012-ZOO-1993, Specifications for the Regulation of Chemical, Pharmaceutical, Biological and Food Products for Animal Use or Consumption (3 pages, Spanish)

Distribution date: 27 August 1997
The reason for this Amendment to the Mexican Official Standard is that the latter does not deal with the "maquiladora" (in-bond export processing) industry: hence the need to include specifications for them since various enterprises of this kind exist. Sections 8.2.2 and 8.2.3 of the Standard therefore have to be amended to avoid confusion.
Products Covered: Chemical, pharmaceutical, biological and food products for animal use and consumption
Regulation Type: Regular notification
Order Amending the Order of 4 August 1986 on the Use of Additives in the Manufacture of Foods for Particular Nutritional Purposes

Distribution date: 14 July 1997
This draft Order is intended to supplement the Order of 4 August 1986 by authorizing various minerals and vitamins in certain products for particular nutritional uses.
Products Covered: Foods for particular nutritional uses
Regulation Type: Regular notification
Technical Regulations. RTCR 318:1997. Laboratory for the Analysis of Residues of Chemical and Biological Substances Used in Agriculture for Human and Animal Consumption Regulations (10 pages)

Distribution date: 23 June 1997
Establish the technical and legal framework regulating everything to do with the analysis of residues in plants and the environment of chemical and biological substances used in agriculture for human and animal consumption. Applicable to the agricultural sector in general, the agricultural chemical and biological substance industry and the public in general.
Products Covered: 07, 0701, 0703, 0704, 0705, 0706, 0707, 0708, 0709, 0710, 0711, 0712, 0713, 0714, 08, 0801, 0802, 0803, 0804, 0805, 0806, 0807, 0808, 0809, 0810, 0811, 0812, 0813, 0814, 09, 0901, 0902, 0903, 0904, 0905, 0906, 0907, 0908, 0910, 10, 11, 1101, 1102, 1103, 1104, 1105, 1106, 1107, 1108, 12, 1201, 1202, 1203, 1204, 1205, 1206, 1207, 1208, 1209, 1211, 1212, 1213, 1214, 1507, 1508, 1509, 1510, 1511, 1512, 1513, 1514, 1515, 1516, 1517, 1518, 1519, 1801, 1802, 1803, 1804, 1805, 1806. 19, 1901, 1903, 1904, 20, 2001, 2002, 2003, 2004, 2005, 2006, 2007, 2008, 2009, 21, 2101, 2103, 2302, 2303, 2304, 2305, 2306, 2307, 2308.
Regulation Type: Regular notification
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