By the end of the summer, the State of California expects to issue the next (and presumably final) draft of its substantial revisions to regulations that require product warnings for exposures to substances the State considers to be carcinogenic or cause reproductive or developmental harm. The proposed amendments represent the first overhaul of these rules in more than 25 years; not surprisingly, they received focused attention from the business community, including food and beverage companies.
California’s Safe Drinking Water and Toxic Enforcement Action of 1986 (colloquially known as Proposition 65) requires businesses offering products or services in California to provide a “clear and reasonable” warning before exposing any person to more than a threshold level of one or more of roughly 800 listed chemicals.1 The current regulations administered by the Office of Environmental Health Hazard Assessment (OEHHA) provide “safe harbor” warnings that businesses can rely upon to comply with the statute.2
The proposed amendments would make several key changes in the rules. First, in order to satisfy the statute’s requirement to be “clear and reasonable,” new warnings must state that the product “can expose you to a chemical …” known to the State to cause cancer or reproductive toxicity, rather than the current safe harbor language that simply states that the product “contains a chemical….” The proposal would also require warnings in multiple languages for certain product labels or signs. Further, the revised warnings for products that could expose a person to one or more identified chemicals above a threshold level would be required to identify those chemicals, by name, in the warning. Several of the chemicals include foods in the justification for naming those chemicals in the warning:
- Acrylamide appears on the list primarily because “given the popularity of acrylamide-containing foods, the potential for regular exposure is significant.”3
- Foods are also listed prominently as a category of products for which “identification of arsenic exposures … can provide valuable information.”4
- Foods are also listed as sources of exposure to other named chemicals – cadmium, formaldehyde, hexavalent chromium, lead and phthalates.5
The proposed amendments also provide tailored warnings for food products:
“WARNING: Consuming this product can expose you to a chemical known to the State of California to cause cancer [and/or birth defects or other reproductive harm]. For more information go to www.P65Warnings.ca.gov/food.”6
Over the past several months, a variety of companies and groups offered comments and testimony on how OEHHA should revise the draft, and a number of these recommendations would improve the impact of the revised regulations on companies in the food and beverage industries.
Areas of Requested Improvement
A revised draft of the proposed amendments is anticipated in the next several weeks. Businesses in the food and beverage industries should look to the new draft to determine whether and how OEHHA has revised the proposal, including the following particular concerns:
- “Can expose” – Food and beverage companies are among the sectors whose products may contain listed substances that are not intentionally added to the product, but are inherently present. Commenters suggested reverting to the existing “may contain” text in recognition of the unique situation of such products.
- Clarification of the “Sell-Through” or Grandfathering Provision – The earlier proposal included a two-year transition period, but many stakeholders questioned its sufficiency and suggested either a longer period or that all products produced prior to the effective date should receive grandfathered status.
- Preservation of Warnings Approved in Settlements – Many existing products bear warnings derived in court-approved settlements. Commenters recommended explicit language in the amendments that preserves businesses’ continuing ability to use such warnings.7
- Use of Off-Product Warnings – The proposed amendments recognize that a warning may qualify as “clear and reasonable” even if it does not appear in an on-product label. However, OEHHA also rejected off-product warnings that individuals must “seek out.” Several commenters encouraged OEHHA to elaborate on this distinction.
- Multi-lingual Warnings – Commenters sought additional direction on what information would trigger the requirement to provide warnings in multiple languages.
- Supplemental Information – Under the proposal, businesses may provide additional information so long as it does not “contradict, dilute or diminish” the Proposition 65 warning; however, the proposal provides little guidance on what supplemental information is permissible. A range of commenters, particularly those subject to labeling rules from other agencies (e.g., FDA, USDA), articulated the need for additional discussion on this issue.
Regardless of their final form, these new regulations are expected to change the strategies that businesses use to comply with Proposition 65. Under the existing regulations, many businesses have found it easier simply to provide a Proposition 65 compliant warning rather than undertake the costly exposure assessment allowed under the rule to demonstrate that a product does not pose a significant risk. Businesses should assess the new draft to determine how any revisions impact their Proposition 65 procedures in light of the increased requirements and litigation potential expanded under the new regulations.