Companies seeking overseas markets for products made through gene-splicing were encouraged yesterday by news that a 24-nation working group had reached agreement on draft guidelines to coordinate the regulation of biotechnology.
A working group of the Organization for Economic Cooperation and Development agreed this week in Paris on a draft report on biotechnology safety and regulatory issues, the State Department said yesterday.
Biotechnology companies moving pharmaceutical, chemical and other products from the laboratory to market have argued that such an agreement is critical to the growth of the industry. They fear that without such an agreement, individual countries may impose widely varying regulatory standards which would increase development and marketing costs. Some also worry that inadequate health and safety standards could hurt the industry.
The OECD effort to produce guidelines for biotechnology regulation was stalled after the U.S. delegation pulled out of an August meeting that was expected to ratify a document previously agreed to in May. The U.S. government objected to portions of the May draft and rewrote the document, prompting two members of Congress, Rep. John D. Dingell (D-Mich.) and Sen. David F. Durenburger (R-Minn.), to charge that the U.S. delegation had acted to "imperil the success" of the OECD project.
The document accepted yesterday is "a composite" of the two drafts, said a State Department official who asked not to be named. "The U.S delegation is satisfied with the document . . . our concerns have been met," he said.
"The industry is pleased that harmonization of biotechnology regulation within the OECD community appears to be moving in a constructive direction," said Harvey Price, executive director of the Rockville-based Industrial Biotechnology Association, representing 48 U.S. and foreign biotech companies.
The next step is for the draft to be reviewed and adopted by individual governments, which can then use it to design their own codes, regulations or other methods of assessing the risk and evaluating the products of biotechnology.