EPA responds to Invitro International's petition seeking approval of CORROSITEX; company receives patent for CORROSITEX.

IRVINE, Calif.--(BUSINESS WIRE)--May 30, 1995--InVitro International recently filed a petition for rulemaking to the U.S. Environmental Protection Agency (EPA), seeking approval of the use of CORROSITEX in lieu of pH as a measure of corrosivity for the purpose of Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) registration.

"The extensive database compiled by InVitro and supplied to the EPA demonstrates, without question, that the pH test both underestimates and overestimates corrosivity," said Dr. Dennis Chenoweth, senior vice president and head of R&D for InVitro International. "Consequently, these data raise serious doubts about the classification of an entire group of FIFRA-regulated pesticides that have been exempted from additional testing," he continued.

A letter received last week from the EPA's Office of Prevention, Pesticides and Toxic Substances (OPPTS), Dr. Lynne Goldman stated, "InVitro's CORROSITEX submission is under active review by our scientists. The Agency also is currently reviewing the status of skin irritation or corrosivity testing in concert with other Federal agencies. In addition, the Agency is an active participant in international efforts in the areas of validation criteria and policy implications of the use of in vitro methods for toxicology testing. The Agency has been working with the Organization for Economic Cooperation and Development to harmonize testing requirements and guidelines for its members worldwide. InVitro's petition is being considered in conjunction with these activities."

"We are very encouraged by the EPA's supportive efforts in the development of in vitro test methods, and to harmonize standards between federal agencies," stated Rich Ulmer, president and CEO for InVitro International. "We have the U.S. Department of Transportation's recent expansion of the CORROSITEX exemption to include non-corrosive results; we have acceptance by the Occupational Safety and Health Administration (OSHA); now we look forward to adding EPA recommended guidelines to solidify federal regulatory agency acceptance of CORROSITEX technology. Very importantly, this should surface and solve the problem of different branches of government having different definitions and understandings of pH use. It should really help accomplish what our government set out to do in regulating groups of hazardous materials."

InVitro's government relations consultants indicate that the petition should be acted upon in about six months.

In a related development, InVitro obtained U.S. Patent No. 5,411,888 for CORROSITEX on May 2, 1995. Dr. Chenoweth sees the patent as a positive step in establishing the proprietary nature of the Company's technology. "CORROSITEX is far and away the most accurate, consistent, and cost-effective test method for determining the biological corrosivity of substances. We work vigorously to strengthen this technology in an ever-increasing database," he stated.

InVitro International develops and markets proprietary in vitro assay systems to predict potential irritation and/or toxic levels of substances to humans and the environment. Located in Irvine, Calif., InVitro International distributes its products throughout North America, Europe and the Pacific Rim.

CONTACT: InVitro International

Cheryl Daniel, 714/851-8356