California's most well-known right to know law, Proposition 65 ("Prop 65"), has significant changes that go into effect in just under six months. The amendments to Prop 65, promulgated by California's Office of Environmental Health Hazard Assessment ("OEHHA") in August 2016, significantly change what companies are required to put on their warnings if they want "safe harbor" protection from potential legal challenges under the regulations. These changes include, but are not limited to, the inclusion of a pictogram, a new Prop 65 URL, the name of a listed chemical (except for on-product warnings), certain font size requirements, and revisions to the warning language itself. OEHHA issued these changes to Prop 65 warnings in order to assist businesses with compliance and to provide more meaningful warnings to the public. Companies should be aware of these new amendments, and be prepared to manufacture products with these new warnings after August 30, 2018.
Passed in 1986 as a ballot initiative, Prop 65 requires businesses to provide "clear and reasonable" warnings to individuals in the state of California before "knowingly and intentionally" exposing them to a chemical "known to the state to cause cancer or reproductive toxicity." Article 6 of Prop 65 prescribes the requirements for what constitutes a "clear and reasonable" warning. Private citizens are permitted by law to enforce this requirement of Prop 65, and they often do. A business found guilty of violating Prop 65 may face penalties of up to $2,500 per day for each violation. More often, businesses facing Prop 65 lawsuits by private citizens are forced to settle or incur the expense of demonstrating a warning is not required for their products, or that a warning they provided is "clear and reasonable."
Thus, an integral part of Article 6 are the safe harbor provisions. While businesses are not required to use the safe harbor language on their warnings, if they do, their warnings will be deemed "clear and reasonable" under the law. Companies who want to continue taking advantage of the Article 6 safe harbor provisions must have warnings that comply with OEHHA's new Article 6 amendments after August 30, 2018. The amended regulations not only include new safe harbor warning language for consumer product, environmental and occupational exposures, but also for a variety of specific products, chemicals and area exposures like food, alcoholic beverages, prescription drugs, raw wood products, furniture products and petroleum products. Businesses that want to take advantage of the safe harbor protections should make sure they are complying with the appropriate safe harbor provisions for a given product or area requiring a warning.
Many of the amendments add new complexities to the warnings that businesses have never had to consider before. Here, we outline the top 5 major changes to Article 6 that businesses who provide Prop 65 warnings should be aware of:
1. The safe harbor warning language has changed.
Businesses providing Prop 65 warnings for decades used relatively the same warning language for their consumer products: "This product contains a chemical known to the state of California to cause cancer," or reproductive harm. However, after August 30th, this safe harbor warning language will need to change to include:
- The word "WARNING" in all capital letters and bold print;
- The phrase "this product can expose you," rather than the previous language, which simply indicated that a product "contained" a chemical;
- The name of one or more listed chemicals in the consumer product or affected area. If a warning is being provided for more than one endpoint (cancer and reproductive toxicity), the warning must include the name of one or more chemicals for each endpoint, unless the named chemical is listed as known to cause both cancer and reproductive toxicity and has been so identified in the warning;
- The new Prop 65 URL www.P65Warnings.ca.gov. This website, run by OEHHA, provides businesses and consumers with more information about Prop 65 and about certain products and exposures.
Section 25602 of new regulations provide the safe harbor warning language for businesses to use. Listing specific chemicals on warning labels will be a significant new aspect of Prop 65 that businesses will have to comply with. OEHHA does not specify any criteria to use in deciding which chemical or chemicals should be included on the warning. In fact, OEHHA initially considered requiring businesses to list all of the Prop 65 chemicals in their products, but after reviewing comments, decided to give businesses the discretion to decide which of the Prop 65 chemicals in their products to include on their warnings. It is up to each business to decide what chemicals to list for each product and how many to list. Businesses will also need to know if the chemical(s) they decide to list for a given product causes cancer and/or reproductive harm, and use the appropriate safe harbor warning language to this effect.
The only exception to the requirement of using chemical-specific warnings is for on-product warnings provided on consumer products. Under Section 25603(b)-(c) of the regulations, businesses who provide an on-product Prop 65 warning may use truncated safe harbor language: the word WARNING in all capital letters and bold print, the word "cancer" and/or "reproductive harm," and the Prop 65 URL. A person providing an on-product warning is not required to include within the text of the warning the name or names of a listed chemical. Therefore, it is important for businesses to also determine the method in which they will warn-- if they will use on-product warnings and, therefore, not need to list specific chemicals in their warnings.
2. The safe harbor font size requirements have changed.
The regulations prescribe that on-product warnings for consumer products must be in a type size no smaller than the largest type size used for other "consumer information" on the product, but the font must be at least 6-point type. OEHHA defines consumer information as "Warnings, directions for use, ingredient lists, and nutritional information." Many of the specific tailored warnings have other font size requirements. For example, for environmental exposure warnings, the warning signs posted at public entrances in affected areas must be at least 72-point font. Businesses should consult the regulations to see what font size is required for a given product or area warning.
3. Safe harbor warnings must include a pictogram for the first time.
The amended safe harbor provisions now require the use of a pictogram. The pictogram must be a symbol consisting of a black exclamation point in a yellow equilateral triangle with a bold black outline. OEHHA has provided images of the pictogram for businesses to download on its website: https://www.p65warnings.ca.gov/warning-symbol. The pictogram must be in yellow unless the sign, label or shelf tag for the product is not printed in yellow, in which case, the pictogram may be in black and white. The pictogram must be shown to the left of the text of the warning and cannot be smaller than the height of the word WARNING.
4. Foreign language warnings will be required for certain consumer products.
Given California's "linguistic diversity," OEHHA was particularly concerned that businesses provide warnings in alternative languages where the business ordinarily uses that language to communicate with the public. For businesses that already provide consumer information on a consumer product sign, label or shelf tag in a foreign language, OEHHA now requires that the Prop 65 warning must also be provided in that foreign language (in addition to English). This adds an additional challenge for businesses to not only provide clear and reasonable warnings, but also provide the proper translation of a warning that is "clear and reasonable." OEHHA has provided various translations of safe harbor warnings, including Spanish, Chinese, French and Korean, on its Prop 65 website: https://www.p65warnings.ca.gov/warning-translations-businesses.
When including a Prop 65 warning in English and in a foreign language, businesses may also have to include the pictogram twice if the English and the foreign language warnings are not co-located on the product.
5. Don't worry, there is an unlimited sell-through period.
This sell through period makes it so companies do not have to track down and pull products from retailers' shelves and re-label products with the new Prop 65 warnings. OEHHA has provided an unlimited sell-through period for products manufactured prior to the August 30, 2018, effective date that are compliant with the previous Article 6 safe harbor provisions. However, all products manufactured after August 30th need to comply with the new Prop 65 requirements. Manufacturers should clearly identify the date of manufacture so that retailers and customers will know that they are receiving Prop 65 compliant products.