The present proposed CRADA program gives the EPA, in concert with their cooperator, the ability eventually to raise the price of the product sufficient to permit them to extract enough added money to support EPA's internal research activity. This is done under the guise of a need for better quality standards which the agency has openly admitted as its objective in the meetings at Cincinnati: In the face of the available no charge EPA standards samples, and these samples are well known_to_the_trade, the private sector is selling many times the current and proposed EPA'S production requirements for the same items all in a free market at no cost_to_the_taxpayer. Presently or in the future we see no technology transfer from EPA CRADA that would enhance the private sectors capabilities to continue to meet the markets standards preparation needs. The quality of the commercial products is more than adequate to meet current and future EPA needs. The current procedure for purity analysis, solution preparation and quality control of these standards has not been the sole effort or the property of EPA, but a combined work of the scientific community. Procedures have been long available in published literature and journals, and were originally developed to permit virtually any competent chemist to prepare standards in his own laboratory. The chemist has chosen to buy these readily available chemicals rather than prepare them himself as a means of saving his time. The chemist has been doing this for better than ten years. We see no reason why the agency should now attempt to restrict or compete with a viable and profitable small business market area under the guise of FTTA technology transfer solely to finance agency research activity. No matter who receives the wholesale cooperator approval, the remaining suppliers will be essentially forced out of this business area unless some protection is provided to assure the continuation of their business. The analytical standards business is vulnerable to potential abuse. The current proposal will not only remove competition from the market for one laboratory item but represent a treat to all laboratory analytical equipment. The impact, nationwide, may be enormous since the largest use of these standards and equipment, in this environmentally sensitive age, is to run EPA approved tests. If one needs EPA approved standards_to_run_EPA_tests, and there is only one source of these standards, there is a de facto monopoly. This program is only one step away from the mandatory use of EPA standards and eventually equipment by decree or law. The legislative history of the Federal Technology Transfer Act and the language of the Act itself make it clear that the intention of the law is to make technology known to the Federal government available to private industry. The purpose of the law was to foster competition internationally by giving some of the advantages to our industries which other nations give to their industry. Thus, for example, the Act anticipates the licensing of patents obtained by the Federal Government in exchange for royalties to be paid to the government. The legislative purpose was certainly not to foster anti competitive positions among domestic companies and the government by giving any one company or small group of companies the exclusive rights to use technology which is actually already in the public domain. What is represented in the proposed CRADA procedures? Our concern is expressed and supported by what EPA has already established in companion areas of their current operations. As an example, EPA has essentially limited the number of suppliers of certain selected chromatographic column products to two vendors for use with the selected "EPA Methods" promulgated by their office. This is accomplished by specifying a specific_column supplier for packed columns products and another supplier for the capillary columns in the EPA literature published in their distributed "Methods" procedures. The literature does say "or equal" "or equivalent" in some cases. The catch in the phrase is that the protocol established to justify the "or equal" requires the customer and not the vendor to perform the necessary work to prove the unspecified suppliers colum to be "or equal". It is self evident that each and every customer is certainly not going to spend many times the cost of a column to prove a vendors item the "or equal". What this has essentially done is to effectively restrain the trade and directed the business to the two EPA selected supplier's products. Our concern is that this same technique can be easily applied to the standards and solutions business and eventually to all the environmental equipment field. The EPA has already indicated that these proposed CRADA materials will carry an approved EPA marking. We have no assurance that the next step in the procedures is not to say that only EPA approved_standards_and solutions are legally acceptable for analysis regardless of Aside from our previous discussion we need to point out the following: 1. Is "quality" implicit in EPA supervision of standards preparation? 2. 3. 4. 5. We have fully supported findings by suppliers and EPA customers that they many of the EPA samples do not even meet the trade requirements. We have enclosed some of this data on four standards samples provided to us, See attached paper. The proposed FTTA 120 day stability evaluation program for verification of samples will certainly increase the delivery cycle of new products and require higher inventories of many items. The 120 days will essentially be the expiration date of the new product and not the true quality measurements of the products. We would also like to point out that most of this stability data on all EPA chemicals is available in the commercial market with better than ten years of quality assurance evaluation time behind it. There is another danger in sole sourcing the wholesaler operation. Any large retailer can then use the standards as a "loss leader" for other laboratory equipment. This would quickly eliminate the small retailer in this area. The EPA has been obtaining most of their materials from outside contractors or the basic producers. Any of these Contractors certainly could be placed in the most favored position on this matter. The EPA has excused their sample deficiencies in repository product by saying, "Yes we recognize the problems but we only take the supplier information on this items composition and our CRADA program is an effort to improve it. We have presented our major area of concern which we are prepared to defend. We are sure that other suppliers have expressed their concerns and presented their own arguments on their objections to the proposed CRADA program. In addition to the presented arguments, we see many technical and legal problems that can arise through government intervention into a functioning segment of We feel that a fair and equitable standards certification program for all qualified commercial suppliers can be developed that does not threaten the governments and community needs. May we suggest that the proposed third party program by the American Association for Laboratory Accreditation as a possible better approach to a fairer certification program. We offer our better than twenty years of technical and marketing experience in the field for use as deemed appropriate on this matter. We solicit your help in delaying the implementation of the CRADA program until some effective compromise can be reached on this very serious threat to the existing small business market. Very truly yours, CHEM SERVICE, INC. Archenbach Ed Hollenbach President EH/cld TO WHOM IT MAY CONCERN: March 28, 1990 Please be advised that Chem Service, Inc. obtained the following samples from the respective EPA repositories in the manner indicated. Data is supported by in house analysis and outside referee laboratories. Upon request, detail back up paperwork can be provided by Chem Service, Inc. Samples Obtained Research Triangle Park Repository #1. Diazinon - EPA labeled 99.3% Purity. Our analysis showed impurities of approximately 10% surfactants, 2% silca gel and 3% water. We normally find about 10% surfactants in samples we obtain for producers. Our accurate analysis would rate the sample at 84% purity. Probable reason for error was the use of EPA #2. Carbofuran EPA labeled Lot A939, September 4, 1981 Also Our thin layer analysis showed an unidentified spot Probable reason for error may be that EPA protocol methods will not detect these impurities. Without doing additional work, we would rate the purity at 95%, There is available an EPA contractors staff and equipment at Research Triangle Park Repository capable of doing the proper analysis to avoid any |