California’s Office of Environmental Health Hazard Assessment (OEHHA) has adopted its most recent update of the regulations pertaining to “Clear and Reasonable Warnings” under Proposition 65.
The agency announced its adoption on Sept 2. The new regulations will take effect on August 30, 2018, providing a two year period for companies to comply with the new regulations. In the interim period, businesses may choose to comply with either the current or new regulations.
Karyn Schmidt, Senior Director of Chemical Regulation for the chemical industry trade association, American Chemistry Council (ACC) said the requirements “will simply exacerbate Proposition 65’s problems of over warning, consumer confusion and rampant lawsuit abuse.”
“OEHHA’s new warning regulation does not remedy the fundamental problem with Proposition 65 labels: they fail to communicate risk to consumers,” she said. “Requiring labels to arbitrarily list one or more chemicals and include a pictogram hazard symbol does nothing to improve the quality or the meaning of information conveyed to consumers,” Schmidt added.
The trade association also contends that a provision in the regulations that limits what type of supplemental warnings companies can provide “violates affected businesses First Amendment rights.”
However, in its 273 page Final Statement of Reasons, OEHHA asserts that existing safe harbor warnings “lack the specificity necessary to ensure that the public receives useful information about potential exposures.”
The new regulations will “further the right-to-know purposes of the statute and provide more specificity for the content of safe harbor warnings for a variety of specific kinds of exposures, and corresponding methods for providing those warnings.”
The Final Statement of Reasons addresses many of the public comments submitted by members of the regulated community during the year-and-a-half rulemaking process.
OEHHA first proposed an update of the warning regulations in January 2015, with a draft regulation that was roundly criticized by the regulated community. Many commenting parties stated that the provisions of the warning requirements were unworkable, and would not improve customer warnings. Industry comments particularly objected to a proposed mandatory requirement to list 12 chemicals that may be present in consumer products or at certain facilities. These chemicals were subsequently dubbed the “dirty dozen.” A coalition of industry groups spearheaded by the California Chamber of Commerce also took issue with a requirement to use a pictogram depicting an exploding heart with the warnings, a provision considered that the coalition members found both misleading and confusing.
The proposed requirement that was most controversial was warning text that said that the consumers receiving the warnings “will be exposed” to the listed chemical named in the warning, a statement that the industry coalition argued was not true because the possibility of exposure from the products would at best be uncertain.
Each of the three provisions were later discarded after several public meetings and rounds of public comments revealed that many changes had to be made to the proposed regulation before it could be adopted. OEHHA retracted its proposed warning regulation in November 2015, and replaced them with a new draft that was more responsive to concerns voiced by regulated industries. The regulations were re-proposed the same day because the agency was not able to complete the regulation within the one year period required by California’s Office of Administrative Law.
OEHHA subsequently released a revised draft regulation in March and added minor language changes in April to finalize the draft prior to submitting it to the Office of Administrative Law for publication.
New Warning Regulations Create a New Safe Harbor Warning
The regulations require that a warning list the name of one or more chemicals for which the warning is being provided. This is a major difference from the current warning regulations, which do not require the name of any listed chemical to be disclosed in a warning.
The new regulations also require, for the first time, a symbol containing a black exclamation point in a yellow equilateral triangle with a black outline. Where a sign or label does not use the color yellow, the warning can be provided in black and white print. The triangle must appear in a size no smaller than the word “WARNING,” which should appear in all capital letters and bold print. The warning must state:
WARNING: This product can expose you to chemicals including [one or more listed chemicals] which is [are] 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.
Warnings on product labels can be shortened as follows, and do not require that a specific chemical be listed. They must appear in the same size as other consumer information, and in no less than 6-point type.
WARNING: Cancer – www.P65Warnings.ca.gov/product
WARNING: Reproductive Harm – www.P65Warnings.ca.gov/product
New Regulations Allow Electronic Warning, and Require Warnings Prior to Internet Sales
The regulations continue to allow a product-specific warning to be provided on a sign, shelf tag, shelf sign at each point of display of the product, or on a product tag or label.
The regulations also allow, for the first time, a product-specific warning to be provided via any electronic device or process that automatically provides the warning to the purchaser prior to or during the purchase of the product. For internet sales, the regulations require, for the first time, that a warning must be provided on the product display page, or a clearly marked hyperlink using the word “WARNING.” This is differs from the current regulations, which do not expressly address internet sales and provide only that a “clear and reasonable warning” must be provided prior to a potential exposure.
Food Product Warnings
For food products, warnings must state:
WARNING: Consuming this product can expose you to chemicals including [name of one or more chemicals] which is [are] 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.
Specific Product Warning Requirements for Various Products or Facilities
The regulations specify additional warning requirements for the following products or facilities: alcoholic beverages sold at retail stores; food and alcoholic beverages sold at restaurants; prescription drugs; dental care; raw wood products; furniture products; diesel engines; vehicles; recreational vessels; enclosed parking facilities; amusement parks; petroleum products; service stations and vehicle repair facilities; and designated smoking areas.
The new regulations define environmental exposures as follows:
“Environmental exposure” means an exposure that occurs as the result of contact with an environmental source, such as ambient air, indoor air, drinking water, standing water, running water, soil, vegetation, manmade or natural substances or objects, through inhalation, ingestion, or skin or other contact with the body. All exposures that are not consumer product exposures or occupational exposures are environmental exposures.
For indoor environments or outdoor spaces with clearly defined entrances, a warning sign must be posted at all public entrances to the affected area in no smaller than 72-point type. The warning sign must:
Clearly identify one or more sources of exposure; likely to be seen, read, and understood by an ordinary individual in the course of normal daily activity;
Be provided in English and in any other language used on other signage in the affected area.
A warning provided in a notice mailed, sent electronically, or otherwise delivered to each occupant in the affected area. The notice must:
● Clearly identify one or more sources of exposure;
● Include a map that clearly identifies the affected area;
● Be provided at least every three months;
● Be provided in English and in any other language ordinarily used by the person to communicate with the public.
An environmental warning meets the requirements of the regulations if it is provided using one or more of the methods required in Section 25604 and includes all the following elements: (1) The symbol required in Section 25603(a)(1). (2) The word “WARNING” in all capital letters and bold print. (3) For exposures to listed carcinogens, the words, “Entering this area can expose you to chemicals known to the State of California to cause cancer, including [name of one or more chemicals], from [name of one or more sources of exposure]. For more information go to www.P65Warnings.ca.gov.”
A warning to an exposed employee about a listed chemical meets the requirements of the regulation if it fully complies with all warning information, training, and labeling requirements of the federal Hazard Communication Standard (29 Code of Federal Regulations, section 1910.1200 (Feb. 8, 2013)), hereby incorporated by reference, the California Hazard Communication Standard (Title 8, California Code of Regulations section 5194), or, for pesticides, the Pesticides and Worker Safety requirements (Title 3, California Code of Regulations section 6700 et seq.). (b) For occupational exposures to chemicals not covered by subsection (a), warnings may be provided consistent with sections 25601, 25602, 25603, 25604, 25605 and 25607.
Warnings may include supplemental information only to the extent that it identifies the source of the chemical exposure or provides information on how to avoid or reduce exposure. Where a shelf sign or product label provides consumer information in a language other than English, the warning must also be provided in that language.
Retailer and Product Warnings in the Chain of Commerce
The new regulations attempt to protect retailers by setting forth the responsibilities of manufacturers and other entities in the chain of commerce. The new regulations seek to put the primary responsibility for providing warnings on product manufacturers or suppliers, who must either label their products with any required warnings or provide notice and warning materials to retailers. The manufacturer or supplier must specifically identify the product requiring a warning, provide all necessary warning materials, receive written or electronic confirmation of receipt from the retailer’s authorized agent, and renew the notice every six months for the first year and annually thereafter. The manufacturer or other supplier of a product must notify a retailer within 90 days if a new chemical or endpoint (cancer or reproductive toxicity) must be included in a product warning.
A retailer can still be held responsible for failure to provide a required warning for the retailer’s private label products or if the retailer has:
knowingly introduced or caused a listed chemical to be created in a product;
Covered, obscured or altered a product’s warning label;
Received a warning notice and materials from the manufacturer or supplier, but sold the product without supplying the warning; or
Actual knowledge of the potential consumer exposure requiring the warning, and there is no manufacturer or supplier who is subject to Prop. 65 (has 10 or more employees) and a place of business in California or a designated agent for service of process in California. Actual knowledge will be presumed within five days of receiving a 60-day notice of violation.
The new regulations provide that, regardless of the above, a retailer may enter into a contract with the manufacturer or supplier of a product that specifically allocates the legal responsibility for providing a warning.
The new regulations also provide that a retailer must promptly provide the name and contact information of a product manufacturer or supplier to the Attorney General or private plaintiff upon written request.
The adoption of this final regulation effectively repeals all of the prior regulatory provisions of Title 27 of the CCR, Article 6 (sections 25601 et seq.), except those added via an emergency rulemaking in April 2016 related to warnings for exposures to bisphenol A in canned foods and beverages (Sections 25603.3(f) and (g)).