OEHHA PLANS MAJOR CHANGES TO PROPOSITION 65
WARNINGS AND REQUIRED INFORMATION FROM BUSINESS
In May of 2013, amid much publicity, Governor Brown of California released a general outline of a proposal to “reduce unnecessary litigation” and “require more useful information” related to the warnings required by Proposition 65. See Sections 25249.5 to 25249.13 California Health & Safety Code (“H.&S.C.”). These and other Proposition 65 related statutes may be found at http://www.oehha.ca.gov/prop65/law/P65law72003.html. There was much optimism that the program would help address the rampant greenmail that is commonplace. There was also hope that many of the flaws in Prop. 65 litigation would be addressed, such as those discussed at http://www.rmkb.com/tasks/sites/rmkb/assets/image/The_Flaws_of_Prop.65_TCH.pdf.
The process has now undoubtedly become better for restaurants, parking garages, and bars facing a narrow range of claims (chemicals in food, alcohol, vehicle exhaust, and tobacco smoke) commonly exploited by an unfortunate coterie of plaintiffs who seemed more interested in generating revenue for themselves than in addressing important issues of public health. See the amendments to Proposition 65 enacted through Assembly Bill 227 (2013; Assemblyperson Gattto): http://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201320140AB227&search_keywords=. Unfortunately, for the rest of the business community, things are likely to get worse, not better.
The Office of Health Hazard Assessment (“OEHHA”), the administrative agency that oversees Prop. 65, has proposed changes to a) the warnings to be given, and b) additional information to be mandated of companies that is then to be posted on an OEHHA website. For those interested in the regulatory agenda, notices, and explanations by OEHHA of its goals in these “reforms,” see http://oehha.ca.gov/prop65/warnings/030714warningworkshop.html. Public hearings and receipt of written comments can be sent to OEHHA through May 14, 2014. The breadth and scope of OEHHA’s changes are described in detail below.
PROPOSITION 65 WARNINGS
Gone will be the days of the “safe harbor” warnings, which can only mean much more litigation. Warnings will now be required to specifically identify exposures to at least 12 chemicals (or combinations of these chemicals) “commonly found” in consumer products and food, assuming that these are present:
■ chlorinated tris
■ tobacco smoke, and
It is not clear how this list was developed, but OEHHA has noted that this list may grow.
Obviously, warnings will grow longer, not shorter. Warnings must include the following:
Pictogram. The proposal would require the inclusion of the following standard (Globally Harmonized System) pictogram in many categories of warning:
International Health Safety Hazard Symbol
“WARNING”. The word “warning” must appear in all capital letters and bold print. If the product contains one of the aforementioned 12 chemicals, these chemicals must be mentioned in the text of the warning.
“Expose”. The phrasing of the warning must make reference to exposing someone to the listed chemical. This differs from the current safe harbor warning which uses the phrase “this [product, area] contains a chemical known to the State of California to cause [cancer, birth defects, reproductive harm].” OEHHA has concluded that the word “contain” does not express the threat posed by the presence of the chemical, and thus the proposed switch to “expose.”
The use of the Pictogram makes no toxicological sense. Warnings under Proposition 65 are triggered when exposures are to a very minute fraction of that which might cause or lead to harm. The idea that this miniscule exposure is equivalent to some truly dangerous circumstances is truly without any scientific merit.
So, what might warnings look like? Here are some possibilities. But, note, in addition to the list of 12 [or so] chemicals, it may be the word “chemical” below will have to be replaced with the actual listed chemical that is found in the product, area exposure, etc.
• Nonfood and nonmedical consumer product warnings:
“WARNING. This product will expose you to a chemical [or chemicals] known to the State of California to cause [cancer/birth defects or other reproductive harm]. For more information go to www.P65Warnings.ca.gov.”
• Food warnings, other than those on a label:
“WARNING. Consuming this product will expose you to a chemical [or chemicals] known to the State of California to cause [cancer/birth defects or other reproductive harm]. For more information go to www.P65Warnings.ca.gov.”
• Occupational exposures: Warning signs:
“WARNING. Entering this area will expose you to a chemical [or chemicals] known to the State of California to cause [cancer/birth defects or other reproductive harm]. For more information, ask your employer or go to www.P65Warnings.ca.gov.”
Remember that occupational warnings must also appear in the product’s M.S.D.S. sheet.
• Product labels:
“WARNING. Using this product will expose you to a chemical [or chemicals] known to the State of California to cause [cancer/birth defects or other reproductive harm]. For more information, ask your employer or go to www.P65Warnings.ca.gov.”
• General environmental-exposure warning signs:
“WARNING. Persons in [location] will be exposed to a chemical [or chemicals] known to the State of California to cause [cancer/birth defects or other reproductive harm]. For more information, ask your employer or go to www.P65Warnings.ca.gov.”
The proposed methods for transmission of a warning will now specifically include the following methods:
- Warnings on the product itself.
- For internet purchases, warnings that appear before the purchase is completed.
- For catalog purchases, warnings that are clearly associated with the item being purchased.
- Product specific shelf-tags or shelf signs.
- Warnings via an electronic device or process that automatically provides the warning during the purchasing process. [This is a methodology that OEHHA intentionally keeps vague for now; an assessment of the “what” and “how” will be made in the future.]
The fundamental premise is that the consumer cannot be required to seek out the warning, but must see a warning in the appropriate format BEFORE a purchase is made.
OEHHA has indicated that it will develop methods for transmission of warnings and warning language in specific contexts related to food, prescription drugs, medical devices, dental care, and alcoholic beverages, as well as for “environmental exposures” [e.g., for parking lots, apartments, lodging facilities (e.g., hotel, motel), amusement parks].
The OEHHA proposal also includes a provision that recognizes the validity of warning requirements set forth in existing lawsuit settlements. While there is no question that a statute cannot undo settlements entered into as the result of litigation, the result is that there will be two warning regimes in effect, adding to confusion and undermining the understanding of the message being conveyed.
Special Categories of Warnings
OEHHA has noted that it will develop unique warnings for:
- Alcoholic beverage warnings;
- Restaurant warnings;
- Prescription drug and medical device warnings;
- New dental care warnings; and
- Warnings for the following specific environmental exposures: parking facilities, apartments/hotels/lodging facilities, and amusement parks.
For foods and nonmedical consumer goods, in recognition that package size may prevent the lengthy warnings noted, OEHHA is proposing simplified warnings. For example:
- “WARNING: Cancer Hazard”
- “WARNING: Reproductive Hazard”
Proposition 65 Website
The proposal would also require the display on the label of a link to a new OEHHA-hosted website (www.P65Warnings.ca.gov ) to allow the public to access more information relating to the warning, including additional chemicals, routes of exposure, and if applicable, any actions that individuals could take to reduce or avoid the exposure.
Companies would be required to provide the following information to OEHHA for use in the website within 30 days of presenting a warning to the public (e.g., initial sale of a consumer good in California; initial addition of a product to a website):
- The name and contact information for the person providing the warning.
- The name and contact information for the manufacturer of any product the warning is intended to cover.
- The specific products or category of products the warning is intended to cover, including barcodes, if any.
- The type of occupational exposure to a listed chemical the warning is intended to cover, if any.
- The type of environmental exposures the warning is intended to cover, if any, and the affected area.
- The name of the chemical or chemicals for which the warning is being provided.
- Whether the warning is being provided for cancer, or birth defects or other reproductive harm, or both.
- The anticipated route, routes, or pathways of exposure to the listed chemical for which the warning is being provided.
- Reasonably available information concerning the anticipated level of human exposure to the listed chemical, if known.
- Information concerning actions a person can take to minimize or eliminate exposure to the listed chemical, if any.
- Whether the warning is being provided in any language other than English and a copy of the translated warning, if any.
The information would have to be updated within 30 days of a business becoming aware that a) an additional chemical is required to be explicitly noted vis-à-vis the product or with reference to an environmental exposure, or b) any information provided earlier needs to be updated.
OEHHA has also noted that it may a) provide links to other authoritative sources (e.g., FDA, EPA) so that a consumer, for example, can obtain additional information about the product or the chemical, and b) develop additional information to supplement that information provided by business.
One of the problems that will obviously arise is over the toxicological characteristics of the chemical or chemicals being discussed. Many of the listings are based on animal models that make sense when a regulatory program is seeking to avoid the potential for harm. But, whether and to what extent such evidence may support a real and certain threat to human health is an entirely different question. This has one among many issues that Proposition 65 has never addressed, but this dissonance will come to the forefront with the requirements being imposed for input for use on the OEHHA web site.
THE END GAME
Draft regulations are to be issued during the summer of 2014 and final regulations during the summer of 2015.
There is nothing in the proposal that will decrease the likelihood of litigation. Instead, entirely new areas will be open to litigation. A few examples:
- Has a company disclosed all chemicals to which an exposure may occur?
- Are the levels of exposure accurate in the information provided to the OEHHA website?
- Are the potential exposure pathways adequately assessed and defined in the information provided to the OEHHA website?
- Are the area boundaries of environmental exposure properly identified (e.g., impacted zone from exhaust fumes generated in a parking lot)?
And of course all this litigation will contain the same $2,500/day penalty, the same attorney’s fees provision, and the same injunctive relief provisions contained in the current law.
After over two decades of experience with Proposition 65, it would appear that from a public policy perspective, the so-called Green Chemistry approach makes much more toxicological and risk assessment sense. The bottom line in such a Green Chemistry program is that if there is a reasonable risk that a substance is bad for humans and humans are likely to be exposed, then the substance would be banned or at least exposure would be vastly decreased by engineering or design controls.
Proposition 65’s reliance on litigation and greenmail more and more reflects a Rube Goldberg policy that in the real world does little in a meaningful manner to deal with real threats from real hazards.