Glyphosate, one of the most widely used herbicides in the world, is under scrutiny by media and plaintiff groups amid recent reports that it is potentially carcinogenic.
A key ingredient in consumer and industrial weedkillers, glyphosate eradicates broadleaf plants and grasses. Recently, news outlets have reported that low levels of glyphosate have been detected in a broad range of popular food products, among them ice cream, potato chips, crackers, cereal, honey, corn and corn syrup, fruits, soy, milk, eggs, bread and beer.
The notion that glyphosate can be found in food products is not new. But these recent reports have refreshed public interest in the topic. Furthermore, concerned with possible toxicity to consumers, regulators and plaintiff groups are increasingly focusing on the potential link between glyphosate and cancer.
The current regulatory landscape is evolving, and we expect that, over the next few years, we will see regulators and plaintiff groups paying substantial attention to this issue. Change is on the way.
Now is the time for manufacturers to assess potential risk and exposure relating to glyphosate. Below are six considerations for food and product manufacturers.
1. Conflicting studies have classified glyphosate as "not likely to be carcinogenic to humans" and also a "probable carcinogen."
Since glyphosate was registered in 1974, the Environmental Protection Agency and its committees have evaluated its carcinogenic potential, including in 1985, 1986, 1991 and 2015. In 1985, the EPA initially classified glyphosate as a Group C chemical ("Possible Human Carcinogen"), but in 1986, the FIFRA Scientific Panel determined that glyphosate should be classified as a Group D chemical ("Not Classifiable as to Human Carcinogenicity"). Most recently, in 2015, the Cancer Assessment Review Committee classified glyphosate as "Not Likely to be Carcinogenic to Humans," which was then endorsed by the EPA in a September 12, 2016 publication, "Glyphosate Issue Paper." But in 2015, the International Agency for Research (IARC) had issued a statement purporting to reclassify glyphosate as "probably carcinogenic to humans," citing a potential link to non-Hodgkin's lymphoma. Multiple industry groups have challenged the IARC conclusion, claiming that scientific data was withheld from the studies supporting the statement.
2. EPA is currently re-reviewing glyphosate's carcinogenic potential.
EPA is currently reviewing the carcinogenicity of glyphosate and is scheduled to publish the draft glyphosate human health and ecological risk assessment for public comment in the second half of 2017. Glyphosate is also undergoing registration review by the EPA. EPA has set Allowable Daily Intake (ADI) levels for glyphosate in food at 1,750 µg (1.75 mg) per kg of body weight. The European Union's ADI is just 0.3 mg per kg body weight.
3. Glyphosate has been added to California's Proposition 65 list.
The varying positions taken by different regulatory authorities make it difficult for subject entities to implement a consistent approach. California's Safe Water and Toxic Enforcement Act of 1986, known colloquially as California Proposition 65, requires the State of California to maintain a list of chemicals known to cause cancer or reproductive toxicity. A business is required to warn consumers if its product contains a listed chemical, unless the average daily exposure level poses no significant risk of cancer or reproductive harm. On March 28, 2017, California's Office of Environmental Health Hazard Assessment announced that glyphosate would be added to the Proposition 65 list, effective July 7, 2017, notwithstanding industry-sponsored litigation to prevent the listing. California has proposed that the safe harbor level be set at 1,100 µg per day, a stricter intake level than that proposed by EPA's ADI.
4. FDA is beginning to test for glyphosate, but USDA has stopped.
Though USDA and FDA regularly test food samples for general pesticide residues, both have historically opted not to test for glyphosate. While media reports and publicly released FOIA documents suggest that USDA planned to resume glyphosate testing in corn syrup as of January 2017, subsequent reports indicate that as of March 2017, USDA has formally decided against testing for glyphosate residues in food moving forward. Meanwhile, in early 2016, FDA began testing for glyphosate residues in soybeans, corn, milk, eggs and popcorn. Though FDA briefly suspended glyphosate testing in Fall 2016, recent reports indicate that as of June 2017, FDA has resumed the glyphosate testing program for corn, soy, eggs and milk. Plaintiffs' bar and activist groups may attempt to capitalize on FDA and USDA activity through increased FOIA requests.
5. Glyphosate is under heightened scrutiny by activist groups following its detection in food products.
Increasingly, activist industry groups are targeting glyphosate in food products. A number of articles and reports have been published over the last year calling out manufacturers of products containing excess levels of glyphosate. Reports often mischaracterize the risks associated with glyphosate and fail to properly contextualize the relatively de minimis levels of glyphosate identified in their testing. Importantly, while recent reports have suggested glyphosate residue is present in such goods as ice cream, German beers, feminine hygiene products and bread, the chemical has been present only at amounts substantially below the safe harbor levels proposed by the EPA and California. Based on activist reports, higher-target food products may include honey, corn, corn syrup, fresh and processed fruits, soy, milk and eggs, as well as other genetically engineered foods that use pesticides during processing.
6. Glyphosate is the target of regulations outside the United States.
Regulatory authorities outside the United States are also taking notice of glyphosate. In Canada, for instance, the continued registration, sale of and use of products containing glyphosate has recently been reviewed and approved. On April 28, 2017, Health Canada's Pest Management Regulatory Agency rendered its Re-evaluation Decision in relation to glyphosate and concluded that "the products containing glyphosate do not present unacceptable risks to human health or the environment when used according to the revised product label directions." Furthermore, Canada conducted a health risk assessment which concluded that glyphosate is not genotoxic and is unlikely to pose a risk of cancer to humans. Despite this finding, Health Canada has imposed new mandatory labelling requirements on products containing glyphosate, obligating reference to specific statements including mandatory buffer zones, timing for re-entry into sprayed areas and limits of application to areas where the potential to spread to areas of human activity is minimal.
In the EU, the European Chemicals Agency's Committee for Risk Assessment considered glyphosate's classification as a carcinogen after a German proposal recommended an additional classification due to target organ toxicity with repeated exposure. The Committee agreed to maintain glyphosate's classification as a substance that causes serious eye damage and is toxic to aquatic life. However, the European Commission concluded that the available scientific evidence did not meet regulatory requirements to classify glyphosate as a carcinogen. This determination is currently under review by the European Commission. Later this year, it will be taken into account when the Commission and the member states consider whether to approve the use of glyphosate as an active substance in pesticides.
Prudence in a time of change
In sum, this is a period of rapid change around the regulation of glyphosate. Prudent businesses should consider steps to assess their potential risks.
Find out more by contacting any of the authors.