Proposition 65 Warning Regulations Synopsis
On August 30, 2016, the California Office of Administrative Law approved California’s nearly three-year effort to overhaul Proposition 65’s longstanding warning regulations. The new regulations, promulgated by the Office of Environmental Health Hazard Assessment (OEHHA), are a significant departure from the rules that businesses have relied on for decades. Accordingly, businesses will have to reassess and potentially overhaul their long-established compliance programs.The new regulations provide “safe harbor” warning content and methods for consumer product exposures, environmental exposures, occupational exposures, and tailored “safe harbor” warnings and methods for specific types of products and facilities. The new regulations also clarify the responsibility between manufacturers, retailers and others in the supply chain to provide warnings. Although the regulations were adopted on August 30, 2016, there is a two-year phase-in period. Therefore, businesses need not comply with the new regulations until August 30, 2018, but may choose to comply with the new regulations before that time.
Below is a summary of key provisions of the new regulations. To read the full regulation, visit the OEHHA website http://oehha.ca.gov/media/downloads/crnr/art6regtextclean090116.pdf.
New Consumer Product Warning Content
- “Can Expose”: Consumer product warnings must begin with “This product can expose you to . . .” This is a departure from the current warning regulations, which require safe harbor warnings to begin with “This product contains . . .”
- Chemical Specification: If a warning is not provided on the product itself, such as on a shelf display or a store sign, a business must name at least one chemical for which the warning is being provided and specify whether that chemical is known to cause birth defects or reproductive harm, cancer, or both. If warning for one chemical that is a carcinogen and a separate chemical that is a reproductive toxicant, the warning must specify both chemicals. If warning for one chemical that is both a carcinogen and a reproductive toxicant, such as lead, the warning need only specify that chemical. This is a significant change. With the exception of warnings for alcohol, the prior safe harbor warnings do not require warnings to specify chemicals.
- Pictogram: All safe harbor warnings except for food and dietary supplement exposures must contain a pictogram on the left side of the warning of an exclamation point encompassed by an equilateral triangle. Although the triangle must be printed in yellow, it may be printed in black and white only if the sign, label, or shelf tag for the product is not printed using the color yellow.
- URL: All safe harbor warnings must end with “For more information go to www.P65Warnings.ca.gov.” This URL, which is governed by a separately adopted regulation, provides information in the form of “fact sheets” for certain chemicals and provides links to third-party sources for additional information. Perhaps most significantly, the website regulation allows OEHHA to request a plethora of highly technical information from businesses about their warnings. If in receipt of such request, businesses are not required to perform any new or additional testing or analysis to respond to the request. Further, the website regulation contains protections for confidential business information and information subject to legal privilege.
- Translation Requirements: Safe harbor warnings must be provided in English, and if a product sign, label, or shelf tag used to provide a warning also contains consumer information in a language other than English, the Proposition 65 warning also must be provided in that language. The regulation defines “consumer information” as “warnings, directions for use, ingredient lists, and nutritional information.” Consumer information, however, does not include “the brand name, product name, company name, location of manufacture, or product advertising.”
- Cancer Warning:
WARNING: 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. For more information go to www.P65Warnings.ca.gov.
- Reproductive Toxicity Warning:
WARNING: 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 birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.
- Cancer and Reproductive Toxicity Warning:
WARNING: 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 [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.
- Chemical that Is Both a Carcinogen and a Reproductive Toxicant Warning
WARNING: 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 birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.
New Consumer Product Warning Methods
- Brick-and-Mortar Sales:
Warnings that meet the content requirements above will be deemed “clear and reasonable” so long as they are provided using one or more of the following methods:
1) A product-specific warning provided on a posted sign, shelf tag, or shelf sign for the product at each point of the display;
2) a product-specific warning provided via any electronic device or process that automatically provides the warning to the purchaser prior to or during purchase;
3) a product label; or
4) an on-product (i.e., “truncated” warning) as discussed above. This is also a significant change from the prior regulations, which, consistent with the Act, allow warnings to reach the consumer before exposure, i.e., use of the product. Warnings in operating manuals or inside of a boxed unit (such as slip sheets) would not meet this new requirement.
- Internet Sales:
Warnings that meet the content requirements above will be deemed “clear and reasonable” so long as they are provided:
1) on the product display page;
2) a clearly marked hyperlink using the word “WARNING” on the product display page; or
3) by otherwise prominently displaying the warning to the purchaser prior to completing the purchase.
- Catalog Sales:
Warnings that meet the content requirements above will be deemed “clear and reasonable” so long as the warning is provided in a manner that clearly associates it with the item being purchased.
- Truncated Warnings:
Manufacturers may provide a short-form warning if they provide the warning on the product, such as on the immediate container (box, packaging) or product wrapper. Importantly, such short-form warnings need not specify the chemical for which the warning is being provided. Examples of short-form warnings are as follows:
- WARNING: Cancer – www.P65warnings.ca.gov
- WARNING: Reproductive Harm – www.P65warnings.ca.gov
- Supplemental Information:
If businesses want to provide supplemental information to their warnings, such information must be limited to identifying the source of the exposure or providing information on how to reduce exposure if the business would like to benefit from safe harbor protection. Other supplemental information may be included so long as it is not part of the warning content (i.e., package insert or instruction manual).
- Alternative Warnings:
The regulations allow businesses to warn any way they please, but such warnings will not benefit from “safe harbor” protection, and thus businesses providing alternative warnings will have to defend those warnings as being “clear and reasonable” under the Act if challenged.
- Court-Approved Warnings:
A business that is warning pursuant to a court-ordered settlement or final judgment entered before August 30, 2018 may continue to warn using the court-approved warning content and methods notwithstanding the new regulations. Businesses should be aware, however, that this “grandfathering” provision only covers the specific product at issue and company providing the warning. Other companies who sell similar products do not have grandfathering protection, but may request OEHHA to adopt the same or similar warning program through regulation.
- Unlimited Sell-Through:
Products manufactured before the effective date of August 30, 2018 may comply with the current warning regulations and need not comply with the new warning regulations, even if the product is sold in the stream of commerce after the effective date. Products manufactured on August 30, 2018 or later must comply with the new warning regulations.
- WARNING: Cancer and Reproductive Harm – www.P65warnings.ca.gov
Allocation of Responsibility Between Retailers and Manufacturers
- A manufacturer, producer, packager, importer, supplier or distributor of a product may comply with the regulations by either (1) affixing a label to the product bearing a warning , (2) providing written notice directly to the authorized agency for a retailer, or (3) entering into a written agreement with the retailer to allocate legal responsibility among themselves.
- If proceeding under (2), the notice must state that a warning is required, include the name or description of the product or specify identifying information such as the Universal Product Code, include all necessary warning materials, and the retailer must provide written confirmation of receipt of the notice electronically or in writing.
- If proceeding under (2), the retailer is responsible for providing the warning when it has “actual knowledge” of the potential exposure, which is defined as five business days after the retail seller receives notice.
The regulations provide tailored warning content and methods for the following:
1) Food Exposure;
2) Alcoholic Beverage Exposure;
3) Food and Non-Alcoholic Beverage Exposure for Restaurants;
4) Prescription Drug Exposure and Emergency Medical or Dental Care Exposure;
5) Dental Care Exposure;
6) Raw Wood Product Exposure;
7) Furniture Product Exposure;
8) Diesel Engine Exposure (Except Passenger Vehicle Engines);
9) Vehicle Exposure;
10) Recreational Vessel Exposure;
11) Enclosed Parking Facility Exposure;
12) Amusement Park Exposure;
13) Environmental Exposure from Petroleum Products;
14) Environmental Exposure from Service Stations and Vehicle Repair Facilities;
15) Designated Smoking Area Exposure.