Viruses, serums, toxins, and analogous products; definition of biological products and guidelines (4 pages)

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Distribution date: 02 September 1996

The Animal and Plant Health Inspection Service (APHIS) is proposing to amend the regulations by revising the definition of "biological products". The amendment is necessary in order to reflect current usage and advances in scientific knowledge, and to clarify certain parts of the definition. APHIS is also proposing to add a definition of "guidelines" to the regulations. Guidelines are used to assist manufacturers of veterinary biologics and other interested persons regarding test procedures, methods, and other considerations that would be acceptable to the agency in support of licensure of a veterinary biological product.

Products Covered: Veterinary biological products

Regulation Type: Regular notification

Veterinary drugs Animal health

Carcinogenicity Testing of Compounds Used in Food-Producing Animals (2 pages)

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Distribution date: 30 July 1996

The Food and Drug Administration (FDA) is proposing to revise the regulation that sets forth the requirements for the carcinogenicity testing of compounds used in food-producing animals to allow the Agency and sponsors greater flexibility when choosing the types of studies used for testing the carcinogenicity of compounds used in food-producing animals. FDA is proposing to revise the study requirements because FDA recognizes that advances in models used to assess the carcinogenicity of compounds have been made. The specific requirement that a sponsor must conduct oral, chronic, dose-response studies would be deleted under the proposed regulation. Sponsors would have more options for testing the carcinogenicity of compounds used in food-producing animals.

Products Covered: Compounds used in food-producing animals

Regulation Type: Regular notification

Animal health Veterinary drugs

Procedures for inspection of pesticide manufacturers, importers and exporters. Available only in Portuguese, 35 pages.

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Distribution date: 02 May 1996

Describes the procedures to be followed by the inspectors to supervise pesticide manufacturers, exporters and importers.

Products Covered: Insecticides, fungicides, herbicides (3808)

Regulation Type: Regular notification

Pesticides Plant health

Amendment of Specifications for Food (Additional establishment of pesticide residue standards) (available in English, 8 pages)

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Distribution date: 11 April 1996

To propose the establishment of Maximum Residue Levels for 31 agricultural chemicals.

Products Covered: Edible vegetables and certain roots and tubers (HS:07), Edible fruit and nuts (HS:08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.09, 08.10, 08.11 and 08.12), Coffee (HS:09.01), Tea (HS:09.02), Ginger (HS:0910.10), Cereals (HS:10), Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS:12.01, 12.02, 12.04, 12.05, 12.06, 12.07, 12.10, 1212.91, 1212.92 and 1212.99), Cocoa beans (HS:18.01)

Regulation Type: Regular notification

Food safety Human health Pesticides Maximum residue limits (MRLs)

Draft Mexican Official Standard NOM-049-ZOO-1995, Minimum Requirements for Bacterins Used to Prevent and Control Bovine Pneumonic Pasteurellosis Produced by Pasteurella Multocida, Serotypes A and D

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Distribution date: 20 March 1996

The present Mexican Official Standard is mandatory throughout national territory and is intended to establish the minimum requirements for bacterins used to prevent and control bovine pneumonic pasteurellosis caused by Pasteurella multocida, serotypes A and D.

Products Covered: Bacterins

Regulation Type: Regular notification

Animal diseases Animal health Veterinary drugs

Draft Amendment of Mexican Official Standard NOM-048-ZOO-1996, Minimum Requirements for Vaccines Against Aujeszky's Disease

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Distribution date: 01 March 1996

This Mexican Official Standard is mandatory throughout national territory and is designed to establish the minimum requirements to be met in respect of the active substances in vaccines and vaccine batches against Aujeszky's disease.

Products Covered: Vaccines against Aujeszky's disease

Regulation Type: Regular notification

Animal diseases Veterinary drugs

Draft Mexican Official Standard NOM-047-ZOO-1995, Minimum Requirements for Vaccines, Bacterins and Antigens Used in the Prevention and Control of Avian Salmonellosis

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Distribution date: 29 February 1996

This Mexican Official Standard is mandatory throughout national territory and is designed to establish the minimum requirements to be met in respect of vaccines, bacterins and antigens used in the prevention and control of avian salmonellosis.

Products Covered: Vaccines, bacterins and antigens used in the prevention of avian salmonellosis

Regulation Type: Regular notification

Animal health Animal diseases Veterinary drugs

Draft Mexican Official Standard NOM-043-ZOO-1995, Minimum Requirements for Vaccines against Classic Swine Fever

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Distribution date: 12 January 1996

This Mexican Official Standard is mandatory throughout the national territory and is designed to establish the minimum requirements for domestically produced or imported vaccines against classic swine fever.

Products Covered: Swine

Regulation Type: Regular notification

Animal health Animal diseases Classical Swine Fever Bovine Spongiform Encephalopathy (BSE) Veterinary drugs

Draft Mexican Official Standard NOM-039-Z00-1995, Minimum Requirements for Vaccines, Antigens and Reagents Used in Prevention and Control of Rabies in Domestic Species

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Distribution date: 23 November 1995

This Mexican Official Standard is mandatory throughout the national territory and is designed to establish the minimum requirements for vaccines, antigens and reagents used in prevention and control of rabies in domestic species.

Products Covered: Vaccines, antigens and reagents used for rabies prevention and control

Regulation Type: Regular notification

Animal health Animal diseases Veterinary drugs Zoonoses

Draft Mexican Official Standard NOM-038-ZOO-1995. Minimum Requirements for Bacterins used in the Prevention and Control of Bovine Leptospirosis

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Distribution date: 27 October 1995

This Mexican Official Standard is mandatory throughout Mexican territory and is intended to establish the minimum requirements for bacterins used in the prevention and control of bovine leptospirosis.

Products Covered: Bacterins

Regulation Type: Regular notification

Animal health Veterinary drugs

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