Document vBLmmYdD69evk7ROmKwEwov96

CHEMICAL MANUFACTURERS ASSOCIATION September 11, 1979 Mr. Fred R. Currant Corporate Counsel Industrial BIO-TEST Laboratories, Inc. 1810 Frontage Road Northbrook, Illinois 60062 Dear Fred: An agreement dated February 1, 1973, was signed between Industrial BIO-TEST Laboratories, Inc. (IBT) and the Chemical Manufacturers Assoc iation (CMA), formerly the Manufacturing Chemists Association, for IBT to conduct a "Chronic Vapor Inhalation Study with Vinyl Chloride". This agreement was extended to include ail additional exposure group on 22, 1973. References to this study in communications received by CMA from IBT bear the study identification of IBT No. 663-03222. The exper imental design incorporated in the protocol appears in Appendix A, which is attached. The Vinyl Chloride Audit Task Group and the pathologist serving as a consultant to CMA have expended in excess of LJ^OOhours auditing and studying ways in which data of meaningful value might be salvaged from this research agreement. After their large expenditure of time and money, little or nothing of salvageable value has evolved, and it must be concluded the study has gross, irreparable deficiencies. Little value can evolve from audits of other equally important records and research material, since inadequate pathologic studies and/or observa tions and insufficient numbers of tissues preclude scientifically valid con clusions on tumor incidence and dose-response relationships. Data presented show that there is just cause that IBT (1) reimburse CMA for all costs of administering and auditing the agreement of February 1, 1973, as amended, (2) refund to CMA all funds paid to IBT against this . agreement, and (3) supply funds required in excess of (2) to permit CMA to have the program, as amended, properly conducted at another laboratory. ice rely yours. EBF:jbf Enclosure s bcc: J. T. Seawell (Append! 1825 Connecticut Avenue, NW Wffsmngton, Vice President and General Counsel 'flu oJ SL 095575