Microbiologically and Virologically Characterized Research Animals

Added: Apr 16, 2012 8:04 am NOTICE OF INTENT SYNOPSIS. For the past 35 years, the EPA has purchased approximately 90% of the research animals utilized by the National Health and Environmental Effects Research Laboratory (NHEERL) under an indefinite-delivery indefinite-quantity contract from Charles River Laboratories. The animals are required for the conduct of a long-range series of short- and long-term research studies on health effects of a wide range of pollutants under varying conditions. This effort will be procured on a sole-source basis from Charles River Laboratories. The circumstance permitting Other than Full and Open Competition is FAR 6.02-1, ?Only one responsible source and no other supplies or services will satisfy agency requirements.? Approximately 80% of these studies are of a continuing or comparative nature, and will require additional animals of the same genetic background in order to produce data that are reliable, reproducible, and viable over time and place. The NHEER L research data have been published in peer-reviewed journals and used to set EPA regulatory standards. It is critical that future research be conducted with rodent models whose genetic constitutions are well defined, stable, and as unvarying as possible to avoid a negative impact to historical-data reliability. All commercial suppliers of research animals maintain specific strains or substrains of laboratory rodents as separate, closed breeding colonies. Primarily through spontaneous mutations or genetic drift, these strains or substrains develop a unique genetic composition that will differ from the same strain or substrain from a different supplier. Differences in genetic composition can introduce study variability that can negatively impact study results, conflict with previous results, and challenge interpretations of a large body of published data. The Agency has concluded (and numerous studies have demonstrated) that where inter-comparability of data is required from one study to another, it is necessary to use a common source of supply to eliminate extraneous variables. Use of animals from a supplier other than Charles River would introduce such genetic, microbiological, and virological variables which would invalidate the research data base and make comparability of data scientifically impossible. For these reasons, the Agency has decided to solicit Charles River Laboratories on a non-competitive basis for the majority of its laboratory animal requirements. Approximately twenty types of research animals of various strains, sexes, ages, weights, etc., may be purchased, including but not limited to: Long Evans Rats; CD IGS Rats; Wistar Rats; F344 (CDF) Rats; Sprague-Dawley (CD) Rats; SHHF Rats; WKY Rats; SHR Rats; Brown Norway Rats; Stroke Prone SHR/SP Rats; F-344/N SASCO Rats; Lewis Rats; CD-1 Mice; BALB/C Mice; C57 BL/6 Mice; C3H Mice; B6C3F1 Mice; New Zealand White Rabbits; LVG Golden Syrian Hamsters; and, Hartley Guinea Pigs. The primary basis for limiting competition is the Agency?s conclusion that there is substantial evidence that animals that are not identical genetically, virologically, and bacteriologically to animals previously used in our research introduce unquantifiable variables into the research protocol and that such variables cast unavoidable doubt on the significance of variations on research results. That element of doubt is of such concern to EPA that it would require a definitive and conclusive demonstration of the error of the conclusion before opening this solicitation for competition. It is anticipated that the contract will be a firm fixed price, indefinite delivery/indefinite quantity type of contract. The contract will have a base period of 12 months with four 12-month options. Anyone wishing to request reconsideration of the Justification for a non-competitive procurement must provide such a demonstration to the Agency within 15 days of this Notice. Any such inform ation submitted will be evaluated according to its conclusiveness.