While there is still a possibility that Monsanto will prevail in its legal bid* to get glyphosate removed from the Prop 65 list, there is no guarantee that this will happen before July 2018, meaning companies selling goods in California should start preparing now, an Office of Environmental Health Hazard Assessment (OEHHA) spokesman told FoodNavigator-USA.
As for the safe harbor level, he said, the OEHHA has proposed 1100 micrograms as a threshold for daily exposure, and will make a final determination shortly.
He added: “We’ve had 1310 public comments about the NSRL [no significant risk level] of 1100 micrograms and we hope to finalize the safe harbor level long before our deadline of March 2017 [12 months after it was first proposed].”
'We’re not expecting warnings for packaged food products'
So what might a 1100 microgram threshold mean for packaged food companies using ingredients from crops that may have been sprayed with glyphosate and might contain trace levels of pesticide residue? Would they likely fall below the safe harbor level [based on estimated average daily consumption by users of the product]?
The OEHHA spokesman told us: “I can’t tell you with certainty which products will be affected [if the 1100 microgram threshold is finalized], but we’re not expecting warnings for packaged food products [where trace levels of glyphosate residues may be detectible].”
Attorneys: No room for complacency
Reassuring though that may sound, however, food manufacturers would be well advised to start asking their ingredients suppliers exactly how much glyphosate residue might typically be detectible in their raw materials (eg. oats), so they can then calculate how much glyphosate may in turn end up in their finished products (eg. snack bars, hot cereal), said Carol Brophy, an attorney at Sedgwick LLP, who has helped defend clients against scores of Prop 65 lawsuits.
They can then calculate a person’s estimated exposure to glyphosate based on the reasonably anticipated use of the product by the average consumer, so that should they face a legal challenge over why they have not issued a Prop 65 warning on their snack bars or oatmeal, they can show that they are below the safe harbor level.
In other words, just because the safe harbor level of 1100 micrograms seems to be targeting Monsanto, rather than packaged food companies, that doesn't mean for certain that they won't be sued, Brophy told FoodNavigator-USA.
As has been the case with scores of other Prop 65 chemicals for which there are safe harbor levels, many food companies choose to settle when threatened with legal action - even when they know they are likely below safe harbor levels - simply because it’s cheaper than hiring the experts and conducting the tests to prove that you are adhering to the law, she said.
"If your attorney can explain from the outset that there is no violation, oftentimes these plaintiff's lawyers will go away, but it costs money to do this."
Forrest Hainline, a partner in Goodwin Procter's litigation department, also urged packaged food manufacturers not to be complacent, and assume this development won't affect them: "I predict glyphosate will be the next acrylamide and many foods will be targeted. Even though the interest in glyphosate focused on Roundup, it shows up in many foods, which will become targets for Prop 65 plaintiffs."
In other words, just because levels are below the safe harbor level "does not mean they [food manufacturers] will not be sued," he added.
"Anytime we have a new listing for a product found in food, it promises a new litigation front."
Prop 65 “continues to be a hotbed of activity,” according to an analysis of food litigation trends recently conducted by law firm Perkins Coie. “Proposition 65 warning letters impacting the food and beverage industry have increased steadily over the last five years. In 2016, plaintiffs filed nearly 250 warning letters regarding food, beverages or spices—many of which identified multiple products and companies. Plaintiffs also continue to file notices relating to acrylamide (potato and sweet potato snack foods, vegetable chips, prune juice and olives), cadmium (seaweed, shellfish products and cocoa products) and arsenic.”
Manufacturers should also be aware that for online purchases, the product display page should include the warning language or a clearly marked hyperlink with the word WARNING that links to the relevant Prop 65 warning, it added.
Meanwhile, new regulations effective on August 30, 2018, require Prop 65 warning language to be tailored to the specific chemical. (eg WARNING: Consuming this product can expose you to lead, which is known to the State of California to cause birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov/food .)
Prop 65 blues
Prop 65 requires manufacturers selling products in California to give clear warnings if their products expose consumers to 800+ chemicals linked to cancer or reproductive toxicity.
Despite its laudable aims, however, Prop 65 has proved controversial, with critics of the law saying many Prop 65 chemicals are present at trace levels in scores of foods without presenting a threat to human health, while safe harbor levels enshrined in Prop 65 are unrealistically low.
The primary frustration for manufacturers, however, is that even if they can prove they are under Prop 65 safe harbor levels, the costs associated with defending yourself (hiring a toxicology expert, legal fees etc) will likely exceed whatever amount plaintiffs demand in settlement [most cases are settled], prompting some lawyers to argue that Prop 65 has turned into a form of “legalized blackmail."
SAFE HARBOR LEVEL: Public comments submitted to the OEHHA over its proposed 1100 microgram daily exposure threshold to glyphosate have been mixed, with many respondents arguing that there is no safe level of exposure. As one commentator observed: “No level should be acceptable. It's a chemical that causes cancer and it is not safe.”
Ken Cook, president of the Environmental Working Group, added: “While we applaud today’s action, we do believe the state can take additional steps to further protect its most vulnerable populations from this dangerous chemical... The legal limit for glyphosate should be roughly 100 times lower than California’s proposed level to be effective in safeguarding children’s health."
Other commentators, however, argued that the OEHHA is not basing its decision making on sound science, with the California League of Food Producers(CLFP) asking: "How can the agency quantify an NSRL [no significant risk level] when at least nine other international organizations indicate that there is no risk? Establishing a finite NSRL also risks creating conflicts with tolerances set by the US Environmental Protection Agency for glyphosate residues in food.”
Glyphosate and safety
A 2015 statement from the International Agency for Research on Cancer (part of the World Health Organization) that glyphosate was ‘probably carcinogenic to humans’ was the trigger behind the OEHHA action.
The IARC statement was also cited in a wave of lawsuits against General Mills, Post Foods and Quaker (PepsiCo), who were sued last year on the grounds that no reasonable consumer would expect ready-to-eat cereals, bars and snacks labeled as '100% natural' to contain even trace amounts of synthetic pesticide residues, regardless of the legal limits.
Monsanto, however, said it was baffled by the IARC’s statement as “there is no new research or data that was used; the most relevant, scientific data was excluded from review; the conclusion is not supported by scientific data; and there is no link between glyphosate and an increase in cancer when the full data set is included in a rigorous review”.
It also noted that the IARC's findings were inconsistent with those of two other WHO programs – the Core Assessment Group and the International Program on Chemical Safety – which have both concluded glyphosate is not carcinogenic.
A November 2015 report from the European Food Safety Authority (EFSA) also found that "glyphosate is unlikely to pose a carcinogenic hazard to humans and the evidence does not support classification with regard to its carcinogenic potential."
On April 29, 2016, the EPA posted a report concluding that glyphosate is “not likely to be carcinogenic,” but later took down the report and said it would publish a full assessment at a later date.
Meanwhile, a May 16, 2016 report by the Food and Agriculture Organization of the United Nations' (FAO's) Panel of Experts on Pesticide Residues in Food and the Environment, and the World Health Organization (WHO) Core Assessment Group on Pesticide Residues found that "glyphosate is unlikely to be genotoxic at anticipated dietary exposures."
*Monsanto sued the OEHHA last year after it announced its intention to add glyphosate to the Prop 65 list, and lost the case, but is currently appealing the decision.
“Glyphosate is not carcinogenic, and the listing of glyphosate under Prop 65 is unwarranted on the basis of science and the law. California's sole reason for listing glyphosate under Prop 65 is the fatally flawed classification by IARC, which ignored crucial scientific data that undermines its conclusion.
“OEHHA's decision to list glyphosate is contrary to its own scientific assessment, which determined that glyphosate is not carcinogenic, as well as the conclusions of the U.S. Environmental Protection Agency (EPA), the European Chemicals Agency (ECHA), and every regulatory body in the world that has studied glyphosate. We will continue to aggressively challenge this improper decision.”
Monsanto June 27, 2017