Live from San Francisco, Kelley Green Law Blog is reporting today from the Prop 65 Clearinghouse 2018 Conference …. the largest annual assemblage dedicated to the cottage industry that is California’s “Proposition 65.”  Uniquely, the Clearinghouse conference brings together the full spectrum:  California regulators, the plaintiff’s bar, defense and corporate in-house counsel, and assorted other ne’er-do-wells. It’s a great opportunity to be reminded, from my usual defense counsel perch, of what motivates “the other side” and to gain insights into the latest trends, current developments, and future direction of the program.  Forthwith are some of those “insights,” observations and other musings from the front lines of Prop 65:

•  There are a lot of people here … more than ever before (a good sized ballroom’s worth) and the first year it is “sold out.” And not just folks from California.  Testament to the broad interest of the newly in force amendments and, generally, the long reach Prop 65 has for companies from all over and anyone whose products may be sold in the state (meaning:  almost everyone).

•  The best and most enlightened of the plaintiff’s bar do have a good story to tell, highlighting true successes of the program over the last three decades (perhaps the greatest of which is focusing attention, and more thoughtful analysis, on the chemicals in the products we use and encounter every day) … even if it is just part of the story and comes at a significant cost in not only economic terms, but in undermining ACCURATE risk communication and management.

•  Quote of the Day 1:  “Keep the blood pressure under control.”

• Prop 65 is entering a new phase with the advent of the amended warning requirements and emerging judicial challenges … some of the chief questions:  How will “private enforcers” react to departures from the new “safe harbor” warning text and mechanisms?  Will defense counsel launch a wave of preemptive challenges in the wake of the glyphosate “compelled false speech” First Amendment case?

•  Internet warnings very much warrant an entire panel session … for good reason as e-commerce expands exponentially.  Private enforcers are active web surfers!

•  Quote of the Day 2:  “how will the bounty hunt- errrr…. private enforcers react ….?”

•  What’s next from OEHHA?  Expanding warning website chemical “fact sheets.”  Increased use of “information request” authority to obtain from companies details on the source, concentration, route, etc. of the exposure for which a warning is being provided.  Guidance or amended regs on the duty to pass information through along the supply chain.

• The “safe use determination” process is seeing a significant uptick in interest.

• Overwarning is still a major issue despite the goal of the new amendments to reduce “prophylactic warnings.”  Of course it is – the amendments did nothing to address the main issue with Prop 65 (the determination as to WHEN a warning is required) or change the incentives to provide a warning out of an abundance of caution.

•  The retailer/manufacturer provisions on “clarification” of responsibilities throughout the supply chain is riddled with ambiguities and questions with which the market is struggling.  Who is an “authorized agent” for retailer notifications? What and how many warning materials must the manufacturer provide?  How are distributor instructions/notifications to be handled?  How should retailers respond when they receive a 60 day notice?  How can private enforcers certify that a retailer may or may not be held liable under the new standards?

•  More pointedly, the retailer provisions, by allowing independent agreements on liability allocations, may have the perverse result of sticking responsibilities on the smaller actors with less market power.  Which leads to Quote of the Day 3: “Leave me alone or the little guy gets it!”

• There is no foolproof compliance solution … it is a matter of risk tolerance and minimization.  One important component:  testing!  Some is better than none.  For example,  testing showing “non-detect” levels can provide an affirmative defense if done within the past 12 months …. but make sure you meet the requirements of section 25900(a), such as use of a proper test method and a certified laboratory.  Also, how many samples are enough?  There is no set answer but look to do enough for statistical power (maybe three at least?!) given inherent variability.

And that’s a wrap from the City by the Bay!  All signs suggest that next year’s conference will be at least as well attended.  As always, for the latest on Prop 65 stay tuned to Kelley Green Law Blog.

 

Today, August 30, 2018 … marks the date that the 2016 amendments to the warning requirements of California Proposition 65 go into full effect.  This brings to a close the two year phase-in period for the new “safe harbor” warning provisions, meaning that those ubiquitous “old” warning signs are no longer considered de facto compliant … what a difference a day makes!  Just yesterday, those very same signs were accepted as “clear and reasonable,” but no more (at least for products manufactured after today).   Further, and perhaps of most importance, the new provisions governing retailer and supply chain liability for providing warnings now go into effect.

For more details, and analysis that attempts to wade through the swamp of Proposition 65, please see my prior blog post.

Out with the Old
In with the New

 

Historically, the bulk of Prop 65 actions have come from plaintiff attorneys sending waves of people into retail stores in California to purchase and then test products for possible exposures to listed chemicals.  This paradigm is shifting increasingly to a new pattern of plaintiff behavior:  scouring websites for possibly non-compliant products that are sold and shipped to California addresses.  While statistics on the source of alleged Prop 65 violations are not available, it is clear from experience, at least anecdotally, that perhaps a majority of new cases are instigated by on-line sales.

Companies that may not consider themselves to be “selling in California” very often are, at least from a Prop 65 perspective.  Unless your company strictly limits distribution and sale to places outside of California, you may end up in the Prop 65 web.  And internet sales are the easiest way for a Prop 65 plaintiff to track you down.

The recent amendments to the Prop 65 warning regulations provide compliance guideposts for the sale of products on-line that may result in exposure to listed chemicals.   For an internet purchase to qualify for the “safe harbor” warnings prescribed in the new regulations (i.e., for the warning to be presumed compliant), a business must provide either the warning statement or a clearly marked hyperlink using the word “WARNING” on the website product display page, or otherwise prominently display the warning to the purchaser prior to completing the sale.  Guidance from the Prop 65 implementing agency, the Office of Environmental Health Hazard Assessment (OEHHA), earlier this year clarifies that in addition to the website warning, the consumer also must receive the warning through the traditional methods related to sale of consumer products — meaning that a warning must appear on the product label (on the product itself or its immediate packaging/container) as well as be delivered prior to completion of the on-line sale.

In short, if you do any business on-line, your company should be thinking about Prop 65 and the tangled web it weaves for any product that may end up within California.

In a remarkable and perhaps precedent-setting decision, a California appellate court sided with cereal manufacturers in ruling last week that Proposition 65 cancer warnings for acrylamide were preempted by federal policy encouraging the consumption of more whole grains.  In overturning a lower court ruling finding no preemption, the three-judge panel of the state appeals court gave remarkable deference to Food and Drug Administration policy and guidance which, the court stated, “contained persuasive reasoning why Proposition 65 acrylamide warnings on whole grain cereals would mislead consumers and lead to health detriments.”

Continue Reading Prop 65 Court Win for Cereal Manufacturers Sets the Table for Further Challenges to Warning Requirements

We are seven weeks away from the California Proposition 65 amendments adopted in 2016 going into full effect, including substantial changes to the wording and format for providing warnings, new guidance on providing warnings for website purchases, and tailored warnings for certain exposure scenarios (such as restaurants), as well as important new provisions regarding the division of responsibility for providing warnings among retailers, manufacturers, distributors, and others in the supply chain.  August 30 marks the two year anniversary of issuance of the revised warning regulations and the end of a transition period during which either the prior or new “safe harbor” warning requirements could be utilized to ensure compliance.   As of August 30, only the new “safe harbor” warnings can be relied upon to avoid potential challenge for failure to provide a “clear and reasonable warning.”  Also on that date, for the first time, the new provisions addressing retailer liability, and the obligations of manufacturers and other suppliers seeking to pass on warning responsibilities, become effective.

To briefly recap, the major new provisions include:

(1) First and foremost, the familiar old Prop 65 signs (on right below) will give way to a more detailed warning, including the newly required posting of the yellow triangle “warning symbol,” identification of at least one specific chemical for which the warning is provided, a statement that the product “can expose” the consumer to the chemical (and not simply that the product “contains” a listed chemical), multi-lingual labeling, and reference to the Prop 65 website:

The soon-to-be “old” “safe harbor” Prop 65 warning
  • For exposure to carcinogens:  “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.”
  • For exposure to reproductive toxins:  “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.”
  • For exposure to both carcinogens and reproductive toxins: “WARNING: This product can expose you to chemicals including [name of one or more listed 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.”

(2) New abbreviated “on-product” warnings for consumer goods.

(3) Specific “safe harbor” warnings for the certain products or exposure scenarios:  Food; Alcoholic beverages; Restaurants; Prescription drugs; Dental care and emergency medical care; Raw wood; Furniture; Diesel engines; Passenger vehicles or off-road vehicles; Recreational vessels; Parking garages; Amusement parks; Petroleum products; Service stations and vehicle-repair facilities; and Designated smoking areas.

(4) For internet purchases, the safe harbor warning must be provided by including either the warning or a clearly marked hyperlink using the word “WARNING” on the website product display page, or by otherwise prominently displaying the warning to the purchaser prior to completing the purchase.  Guidance from the Prop 65 implementing agency, the Office of Environmental Health Hazard Assessment (OEHHA), earlier this year clarifies that in addition to the website warning, the consumer also must be receive the warning through the traditional methods related to sale of consumer products (e.g., a warning also must appear on the product label or be provided in another format).

(5) In terms of clarifying retailer/manufacturer responsibility, the new provision provides manufacturers (and others in the supply chain) with two basic options: (1) affix an appropriate warning to the product; or (2) provide written notice to the retailer regarding the required warning for the product.  The manufacturer (or other suppliers) then must obtain confirmation of the retailer’s receipt electronically or in writing.  If a retailer fails to post or obscures or alters a warning when the manufacturer has provided it, only then will liability potentially fall on the retailer for failing to warn consumers.

Keep in mind that the amendments did not alter the more fundamental question of how a business decides whether to provide a warning, but rather only relate to how that warning is provided.

A detailed overview of the 2016 amendments is available here.  

In addition, OEHHA sent an email blast yesterday with a catalog of guidance materials available for businesses, including the agency’s own overview of the new regulations and links to informative FAQs and Q&As.

 

Responding quickly to a landmark court ruling requiring coffee sold in the state to bear a Proposition 65 warning label, California has initiated a proposed rulemaking to clarify that exposure to acrylamide and other chemicals “created by and inherent in the roasting of coffee beans and brewing of coffee” do not pose a significant risk of cancer.  Given the widespread criticism, and even outright mockery, of the need to place a cancer warning label on a product for which there is no evidence of increased cancer risk, the state’s action is a politically astute move.  Arguably, it is a much needed regulatory adjustment to save the Prop 65 program from one of its worst public excesses, and the proposal explicitly recognizes the benefit of “helping to avoid cancer warnings for chemicals in coffee” that do not actually pose a risk.

In support of the proposal, posted today, the Office of Environmental Health Hazard Assessment (OEHHA) relies on the findings of the International Agency for Research on Cancer (IARC), the only Proposition 65 authoritative body to have evaluated coffee, that “coffee consumption is not classifiable as to its overall carcinogenicity and is associated with reduced risk of certain cancers in humans.”  (For “IARC watchers,” there is some irony in California relying on the findings of that body, the subject of much deserved recent criticism, to take a deregulatory action.)  While acknowledging that coffee is a mixture that contains a wide range of potentially carcinogenic substances, OEHHA finds that “abundant data on coffee show that the carcinogens in this particular mixture should be viewed differently” than other complex mixtures, such as cigarette smoke and diesel exhaust, for which warnings are required.

The proposed rule would adopt a new Section 25704 to the Prop 65 regulations, entitled “Exposures to Listed Chemicals in Coffee Posing No Significant Risk” and stating simply:  “Exposures to listed chemicals in coffee created by and inherent in the processes of roasting coffee beans or brewing coffee do not pose a significant risk of cancer.”

Of course, the regulation, if adopted, does not address exposures to chemicals that are intentionally added to coffee or are present as contaminants through a means other than the inherent process of roasting coffee beans or brewing coffee.

Comments on the proposal are due by August 30 and a public hearing will be held in Sacramento on August 16.  Further information on the proposed rulemaking can be found at:  https://oehha.ca.gov/proposition-65/crnr/proposed-adoption-new-section-under-article-7-no-significant-risk-levels-section.

For our first substantive KelleyGreenLaw blog post, the recent court decision requiring Proposition 65 warning labels to be served with cups of coffee was an obvious choice. The case raises fundamental questions of the nature of “risk” and how it is assessed, as well as how and whether society should require affirmative warnings for exposure to chemicals that, while they may cause cancer or other harm at high doses, quite clearly do not pose any sort of meaningful risk based on everyday experience and common sense. As the case shows, there is plainly no bright line, though perhaps sometimes it is obvious when that line has been crossed….

In upholding the need for warnings served with your daily cup of coffee (at least if you purchase that coffee at Starbucks, Peets, or any of the other dozens of defendants), the California judicial system has missed (at least initially, pending reconsideration or appeal) an opportunity to impart a demitasse of rationality into the infamous Proposition 65 regulatory program. In fairness, it is not the job of the courts to save the state from the well-intentioned but now divorced-from-reality “Prop 65.” That job falls on the California legislature and regulators, who, despite some recent cosmetic changes to the warning requirements, continue to fail to address the fundamental problem with the program: the problem is not so much HOW to provide a warning, but WHEN such a warning is necessary and appropriate.

Ironically, when opining on the 1986 voter referendum (officially the Safe Drinking Water and Toxic Enforcement Act), a leading California newspaper scoffed at what it called the “exaggerated” claims of opponents, proclaiming that, if adopted, the law surely would “not lead to the banning of ordinary table salt or require warning labels on every apple sold or cup of coffee served in California.” By now, you have no doubt heard that this prediction has proved presciently false. On March 28, a California judge issued a preliminary ruling in Council for Education and Research on Toxics (CERT) v. Starbucks Corporation, et al., that businesses that serve coffee to the public must provide a warning that their java contains a chemical (acrylamide) known to the state of California to cause cancer. In a prior ruling, the judge found that defendants failed to demonstrate that acrylamide in coffee posed “no significant risk,” even though acrylamide only has been shown to cause cancer in lab rodents at levels thousands of times greater than one would ever find in a cup of coffee, or in any food for that matter. In fact, the science shows that drinking coffee is not associated with increased risks of cancer.

In the most recent ruling, the court rejected the defendants’ further contention that an “alternative significant risk level” (ASRL) should apply under a provision for chemicals in food produced by cooking necessary to render the food palatable and safe. The argument suggested an opportunity to rationalize, at least for food products, some of the more eye-rolling results of Prop 65. Acrylamide, which is not naturally present in coffee or a host of other food products (e.g., baked or fried starches, chocolate, etc.), is created by the Maillard reaction, which occurs naturally between amino acids and sugars at high temperatures. In light of this, the Prop 65 regulations provide a purported fix by exempting warnings for levels of chemicals that result from necessary cooking.

Unfortunately for your local California barista, the court found that while roasting coffee beans is necessary to make coffee palatable and reduce microbiological contamination, and that the acrylamide present in coffee is a result of the brewing process, the defendants nonetheless failed to establish “the minimum amount of acrylamide that might be necessary” to achieve these goals. Instead, the defendants argued that “acrylamide levels in coffee cannot be reduced at all without negatively affecting safety and palatability.” The failure to explain how acrylamide levels in coffee were the “minimum necessary” may have been the fatal flaw in the defendants’ case. In other words, the defendants had not established that current brewing techniques sufficiently minimized the levels of acrylamide to those unavoidably necessary to render the coffee palatable. Unanswered in the court ruling, however, is an explanation as to why the defendants’ argument was insufficient.

The court decision goes further, however, and asserts that the defendants also “failed to prove that coffee confers any human health benefits” and, therefore, “failed to satisfy their burden of proving that sound considerations of public health support an alternate risk level for acrylamide in coffee.” This holding is curious given that the regulation specifically identifies “necessary” cooking as a prime example of such a public health consideration. The court does not explain why any additional showing is necessary (leaving open for debate what level of cooking is “necessary”). Similarly, the court also would require that defendants use quantitative risk assessment to show “what would be an appropriate alternative risk level, taking into account the identified public health considerations.” However, the California agency already has made this finding when adopting the regulations: “whatever cooking method is chosen, the amount of cooking which is necessary to avoid bacterial contamination or to render the food palatable should provide a basis for the application of [an alternative] risk level.” In other words, the ASRL is to be based on whatever level of the chemical is present in the food as a result of necessary cooking. What more are the defendants supposed to do?

It is unclear why the court found it necessary to impose these additional conditions on the ASRL defense, other than the court’s recognition that the Prop 65 law is to be construed broadly to further its remedial purpose and intent to protect the public. Hence, the exemption “must be narrowly construed so as not to ‘frustrate the purpose of the statute which it implements.” The court’s approach, however, misses an opportunity to mitigate the more absurd results of Prop 65 with a shot of rationality and common sense.

While the defendants arguments made practical (and legal) sense, there is a logic to the court’s decision that a warning should be provided. While that logic may be consistent solely within the existing structure of the Prop 65 regulations, it does not change the well-established fact that coffee simply does not increase your risk of cancer, no matter what California would require businesses to say.

Ultimately, the coffee case highlights why it is imperative that California’s Office of Environmental Health Hazard Assessment (OEHHA), which oversees the Prop 65 program, must revisit the regulations governing when exposure to a listed chemical requires a warning, including with respect to chemicals formed as a result of necessary cooking of food and beverages. The status quo has resulted in a wild proliferation of warnings that render them essentially meaningless and consumers numb to the message. Worse yet, these unnecessary warnings crowd out meritorious warnings that are provided about actual risks. None of this does any good for public health or providing consumers with helpful and accurate information.

This is not to say that Prop 65 has not done some good and had some success stories. It is undoubtedly good that businesses now must think more about the chemicals in their products, and whether they are exposing customers to risks. Prop 65 has resulted in real risk reductions in the form of product reformulations and substitution of safer chemicals. But the vast majority of warnings and enforcement actions for failure to warn, brought almost exclusively by independent plaintiff groups, do not alleviate real risks but address violations that make sense only within the confines of Prop 65.

For the rest of us, coffee still does not cause cancer.