Autogenous vaccines: determining product need and antigen selection, production and testing considerations.

It is estimated that in the 12-month period from May 1999--April 2000 approximately $16.06 million in swine autogenous vaccines were sold in the United States. Swine influenza and PRRS vaccines accounted for over one-half of these sales. Usage patterns suggest USDA regulation covering the production and use of autogenous vaccines may be violated. A proposal for product use and selection criteria that may minimize the potential for abuse of autogenous regulations is described. Using a decision tree, the analysis considers issues such as availability of registered products, recognized strain variations and the current state of vaccine technology. Proposed testing and production scenarios are described that include food safety considerations, yet allow for the rapid production and testing required for autogenous products.

Application of risk assessment to veterinary biologicals: the perspective of the animal health industry.

The authors review the perspective of the animal health industry on the changing regulatory climate for the registration and free circulation of veterinary vaccines. The industry supports the increased mutual acceptance of technical standards, the harmonization of these standards and the use of proper risk analysis for regulating the free movement of veterinary vaccines. The veterinary vaccine industry is relatively small, but a large number of products are manufactured and the regulation of these products is highly complex. This complexity results in divergent policies on the importation of vaccines, thus limiting the flexibility of the industry in deciding where to develop and manufacture products. The industry welcomes moves by governments to dispense with "zero risk' policies and to adopt consistent scientific risk analysis approaches, in line with the World Trade Organisation agreement on the application of sanitary and phytosanitary measures. The risks involved in the handling, development and manufacture of veterinary biological products are reviewed, and the factors to be taken into account in the assessment and in the management or control of these risks are presented. Dissection of the production process into its various phases enables identification of the critical points and application of specific risk control measures. An important aspect of the risk assessment is the evaluation of the existing testing methods. A specific programme intended to establish the equivalence or harmonization of various test methods is being proposed. In conclusion, the industry is willing to be actively involved in the harmonization process and expects an equally clear political and technical commitment from the governments of the major trading countries.

The American manufacturer's view on the EEC texts and harmonization.

In a world that has become increasingly smaller with the aid of modern air travel, computers and facsimile machines, the European Community's efforts toward harmonization are applauded by the Animal Health Institute, representing the major U.S. manufacturers of veterinary biological products. The new and proposed directives and guidelines are based on the latest technology and help ensure that only high-quality safe and effective veterinary biologicals are registered in the European Community. These new legislations are, however, significantly different from the current United States (USDA) licensing requirements. The USDA requirements are designed to ensure the safety and efficacy of veterinary biologicals licensed in the United States and have been effective in doing so. Among major differences between EEC and USDA requirements are the EEC requirements for GLP safety tests, GMP for manufacturing, with increased measures for the prevention of cross-contamination, duration of immunity data, and raw material specifications in excess of those required in the United States. Very tight deadlines for implementing these requirements have been established. In the spirit of international harmonization and with the goal of reducing or preventing potential trade barriers, the AHI would like to propose the formation of an international working group consisting of FEDESA, AHI, CVMP, USDA and other international industry and government officials. It is suggested that annual meetings be held in conjunction with either FEDESA or AHI meetings. Issues to be dealt with include standardization of test requirements, time lines for implementation and other issues that could reduce or prevent trade barriers without adversely affecting product quality.(ABSTRACT TRUNCATED AT 250 WORDS)

Gas-liquid chromatographic determination of alachlor (2-chloro-2', 6'-diethyl-N-(methoxymethyl)-acetanilide) herbicide residues in corn and soybeans.

A method has been developed for the extraction and determination of alachlor (2-chloro-2',6'-diethyl-N- (methoxymethyl)-acetanilide) residues in green corn and soybeans. Residues are extracted with acetonitrile and cleaned up on a Florisil column. The methylene chloride extract is sufficiently clean for electron capture gas-liquid chromatographic analysis and for verification by thin layer chromatography. Average recoveries of spiked samples (0.2 ppm) were 69 and 82% for corn and soybeans, respectively. This procedure could be useful for the detection of the parent compound in these crops soon after field application, but it does not detect metabolites.