California’s Proposition 65 law will soon be 25 years old, and much of its recent focus continues on foods, beverages and dietary supplements, even though the early years were mainly focused on industrial chemicals and contaminants, especially lead, in non-food consumer products. Although Prop 65 addresses only carcinogens and developmental and reproductive toxicants (DARTs), the number of such chemicals on the governor’s list now surpasses 800 listed substances, the largest such list in the world.
Many of us deeply involved with Prop 65 food issues management saw a huge spike in Prop 65-related "60-Day Notices" and lawsuits in the 2000s along two main lines of attack: (1) listed heavy metals (such as lead and mercury) in chocolate and fish products, which have avoided warning labels; and (2) the April 2002 unexpected discovery of acrylamide, a heat-induced Maillard Browning Reaction animal carcinogen, which led to lawsuits and eventual court determinations requiring cancer warnings for French fries and potential warnings coming for some potato chips. Food-related legal activity over the past three years has focused on: (1) very trace levels of naturally occurring and unavoidable lead in juices and packaged fruit products, an action initiated by the Environmental Law Foundation against almost 50 companies; and (2) acrylamide in cereals and brewed and packaged roasted coffees. Both of these Prop 65 actions have happened in spite of the strong backing by the FDA of the human safety of these fruit products and the overwhelming human evidence that coffee drinking actually reduces the risk of several human cancers without increasing the risk of other cancers. The lead issue has been particularly vexing because the "safe harbor level" adopted for lead for daily consumption of a consumer product is 0.5 micrograms. This lead standard is an extremely low but not scientifically justified standard derived by applying Prop 65’s mandatory 1,000-fold safety factor below the acceptable safe level for lead in the workplace. No other law around the world requires such a stringent 1,000-fold safety factor for a developmental toxicant like lead, and many of us believe that this unrealistic safety factor demands a scientific reappraisal.
The addition of food chemicals to the list also remains a major battleground. Another Maillard Browning Reaction contaminant, 4-methylimidazole (4-MEI), was added as a carcinogen in the first week of the new Brown administration following an unsuccessful, three-year effort by industry to convince the state that the chemical decreased tumors in more organs than it increased, citing a National Toxicology Program lifetime rodent cancer bioassay. 4-MEI is found in caramel colorings and is also present in many food and beverage products, even those not containing caramel color. A food industry coalition, including CLFP, is currently involved in a lawsuit against the state to remove 4-MEI from the list.
In sum, foods and beverages have definitely been under siege by Prop 65 for the past several years. Unfortunately, the law and its regulations focus only on the presence of trace levels of individual, listed food chemicals in products, but not on the safety or benefits of the whole food product, nor about real harm to California consumers. The stakes remain very high for agriculture and foods since our products are under increasing pressure from Prop 65.
Article written by James R. Coughlin Ph.D., Southern California Independent Consultant in Food Toxicology and Regulatory Affairs.
California League Of Food Producers