Regulatory harmonization--a vaccine industry perspective.

With growth and diversification of aquaculture has come the dissemination of diseases and the increased need to use control measures, both preventative and therapeutic. Preventative measures include good husbandry practices, adequate nutrition and the use of vaccines. Vaccines for aquaculture have generally fallen under the regulatory control of national veterinary medicinal or biological agencies and with that a diverse range of regulatory requirements for authorization and use. More so than any other food animal industry, aquaculture is an international industry with individual entities holding multinational ownership. This situation has created unique problems for the manufacturers of biologicals attempting to service the industry. In recent years, a concerted effort has been made to harmonize regulations to facilitate international trade of vaccines as well as vaccinated animal stocks and their processed food products within and among trading partners. Standardization of requirements for manufacture and testing would ensure national and international interests and consumers of pure, safe and effective products. As the path to harmonization has been slow and not without disagreements, the question remains: What will the standardized requirements be? The manufacturing philosophies of process control (Good Manufacturing Practice) and governmental final product testing for batch release can create a duplicity of effort on the part of the manufacturer that equates to higher economic costs and greater time constraints. The current lack of standardized quality control test methods often means conducting multiple tests to provide the same result. Although efforts are being made to recognize these differences, historical regulations today are based on injectable vaccines for warm-blooded animals. Administration of vaccine products to cold-blooded aquatic species by immersion, bath and oral routes, as well as by injection, creates interpretive problems for manufacturers and regulators alike. Industry encourages and awaits regulatory harmonization, standardization or equivalence. It also offers and would appreciate an active role in the final process.

Low temperature inhibition on binding, trasport, and incorporation of leucine, arginine, methionine, and histidine in Escherichia coli).

A multiple amino acid auxotroph and a wild type of Escherichia coli K12 were used to study the effects of near minimum growth temperatures on the binding, transport, and cellular incorporation of selected amino acids. Both strains of the bacterium showed the same minimum growth temperature (8 degrees C) when previously grown at 15 degrees C. At 8 degrees C and above, the auxotroph exhibited an overall greater ability to bind and transport amino acids than did the wild type. Below the minimum growth temperature, transport and cellular incorporation including respiration ((uptake) were significantly lower for either organism. The NEU and HEPPEL osmotic shock treatment indicated the removal of the specific histidine-binding protein and the ability to bind histidine was not recovered by further incubation below 8 degrees C. At 8 degrees C and above, the cells recovered their ability to bind histidine within one hour. The evidence presented indicates a direct relationship between the auxotroph's minimum growth temperature and its ability to bind amino acids, specifically methionine.

Effects of multiple use on water quality of high-mountain watersheds: bacteriological investigations of mountain streams.

Bacteriological studies in 1968 and 1969 corroborated earlier findings that a municipal watershed which had been closed to public entry since 1917 yielded water with four to six times the coliform count found in an adjacent mountain watershed open to recreational activities. Similarly, chemical investigations showed higher concentrations of most ions in water from the closed area. Physiological differentiation of coliform and enterococcal bacteria revealed similar types of organisms in both animal droppings and stream water, with fecal coliforms accounting for as much as 70% of the coliform counts observed in the closed area in 1969. Opening of the closed drainage for limited recreation and expanded logging operations in the spring of 1970 coincided with an unexpected decrease in bacterial contamination of that stream. It is postulated that these human activities drove from the watershed a large wild animal population which had contributed substantially to the previous bacterial pollution. It would seem that the practice of closing high-mountain watersheds to public entry is questionable if governmental standards for water quality are to be met, and it also seems that the standards themselves should be reexamined.