California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) has determined that the evidence is insufficient to proceed with the Proposition 65 listing process for genistein, a constituent of soy infant formula. Under the state’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) regulations, to identify the reproductive toxicity endpoint, “it is considered necessary that the evidence for developmental toxicity has resulted entirely or predominantly from prenatal exposure,” OEHHA states. “That is not the case for genistein.” The National Toxicology Program monograph on soy infant formula apparently found “clear evidence of adverse effects of genistein in studies with gestational, lactational, and post-weaning treatment, but does not conclude that the effects could result entirely or predominantly from prenatal exposure.” See OEHHA News Release, April 16, 2014.

As to OEHHA’s consideration of potential amendments to Proposition 65’s clear and reasonable warning regulations, the agency has agreed to extend the public comment period at the request of the California Chamber of Commerce to June 13, 2014. Additional information about this initiative appears in Issue 517 of this Update.


Issue 521

About The Author

For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.