Coffee – a health risk or a health promoter? “Private attorneys general” or the British Journal of Medicine?

There have been a variety of media reports of late regarding the health effects of coffee. Two almost simultaneous news articles demonstrate how our regulatory environment can lead to puzzling contradictions. These same articles illuminate the vast reach and potential impact of California’s Prop. 65.

For those not familiar with Prop. 65, it is a California regulatory scheme whereby producers and distributors of any products and foods used or consumed in California must apply a cancer/birth defect warning on their products if they contain any of 800 different identified substances in levels that might lead to an exposure in excess of the mandated permissible levels. The regulations allow any attorney in California to act as a “private attorney general” to bring suit against anyone who has not properly warned. These suits can lead to injunctive relief, fines and penalties, and perhaps most importantly, an award of plaintiff’s (but not defendant’s) attorneys’ fees.

As a habitual coffee drinker, I was pleased to see that Sam Meredith of CNBC reported on November 23rd about a study from the University of Southampton, published in the British Journal of Medicine, that a review of some 200 previously published medical studies led the authors to conclude that drinking 3 to 4 cups of coffee each day was “more often associated with benefit than harm” from a health perspective. Consuming coffee can reduce the risk of numerous ailments from heart disease to dementia, and even some cancers it is reported.

Yet literally the next day, Bob Egelko in the San Francisco Chronicle reported that 7- Eleven had just obtained court approval of a settlement of a case brought against it alleging that their sale of prepared coffee without warnings was a violation of Proposition 65 as coffee contains an unsafe level of acrylamide, a substance identified as a human carcinogen by the State of California. 7-Eleven had apparently decided that it was wiser to settle this case for $900,000 than risk a court trial on the issue of whether or not consuming coffee truly presents a cancer risk to consumers in the Golden State. No doubt much of the settlement will go to Raphael Metzger, plaintiffs’ counsel in this matter.

The settlement will thus have the effect of giving Mr. Metzger more resources to continue prosecuting the same case against Starbucks and many other defendants that have been sued in the same case. If Starbucks wins its case, presumably customers will not see a Prop. 65 warning plaque on the wall behind their favorite barista, nor a Prop. 65 warning on the new Holiday Season cups. If Starbucks loses its case, those warnings may join the legions of other such warnings that have proliferated across the state. One would be left to wonder whether the citizens of California would be rendered more safe by such warnings, or instead as the University of Southampton and the British Journal of Medicine seem to feel, safer by drinking more coffee?

California’s Proposition 65 Runs Amok with Addition of BPA

plastic-bottlesOn May 11, 2015, the California Office of Environmental Health Hazard Assessment (OEHHA) listed Bisphenol A (BPA) as a reproductive toxicant to be added to the list of chemicals subject to Proposition 65.  Given the widespread use of BPA in numerous consumer applications (e.g., plastics, adhesives, sealants, epoxy resin liners in food containers, and thermal paper such as the paper used to print cash register receipts), the addition of BPA is a significant development for a large number of businesses evaluating compliance with Proposition 65 with respect to BPA in products.

Proposition 65 provides a 12-month period from the date of listing before warnings are required.  Thus, warnings for exposures to BPA will be required starting on May 11, 2016, unless a person in the course of doing business can show that exposures are below the Maximum Allowable Dose Level (MADL) safe harbor limit for BPA.

OEHHA Takes Action with Deadline Approaching

As the deadline for the warning requirement is quickly approaching, OEHHA recently took emergency action with respect to the listing of BPA.  The first action was the issuance of a notice of proposed rulemaking to establish a MADL for dermal exposures from solid materials containing BPA.  The second was an emergency action to allow for the temporary use of a standard point-of-sale warning for BPA exposures from canned and bottled foods and beverages.

Proposed MADL

The warning requirements under Proposition 65 do not apply if a business can show that exposures from a product are less than the MADL established by OEHHA, which puts the business in a “safe harbor.”  Based on OEHHA’s review of the scientific studies, it has proposed a MADL of 3 micrograms/day (dermal exposure from solid materials) for BPA.  Significantly, the proposed MADL of 3 micrograms/day is a level believed to be above that which most people would encounter from a product in normal use.Bisphenol_A

Comments on the proposed MADL are due to OEHHA by May 16, 2016.  Note that this means that the proposed MADL will not be finalized until after the May 11, 2016 trigger date for warnings.

OEHHA Allows Uniform Point-of-Sale Warnings for Canned and Bottled Food and Beverages

OEHHA attempted to develop a MADL for oral exposure (as opposed to the dermal exposures discussed above) that could have precluded the need for an emergency action on the warnings.  However, OEHHA was unable to work through the technical, practical, and timing issues associated with adopting an oral exposure MADL.  Consequently, to avoid potential removal of many food products from the shelves in markets, OEHHA’s proposed solution, as presented in the emergency action, is to amend the regulations to provide for the temporary use of a standard point-of-sale warning as a compliance option.

The compliance option contemplates signs no smaller than 5 x 5 inches with the following warning language:

WARNING: Many cans containing foods and beverages sold here have epoxy linings used to avoid microbial contamination and extend shelf life. Lids on jars and caps on bottles may also have epoxy linings. Some of these linings can leach small amounts of bisphenol A (BPA) into the food or beverage. BPA is a chemical known to the State of California to cause harm to the female reproductive system.  For more information go to:  www.P65Warnings.ca.gov/BPA.

OEHHA’s actions will have a significant impact on businesses seeking to comply with Proposition 65 for products carrying the potential for exposures to BPA.

California Chocolates: Labelled for Lead?

4-2Chocolate is bad for you. But not for the reasons you thought.

Don’t touch that left over chocolate Easter Bunny. Step away from that Hershey’s chocolate bar, and don’t even think of buying a box of See’s chocolates for your mother for Mother’s Day. That’s right, all these delights, and many others, are bad for your health. But not for the reasons that probably first comes to mind.

As recently reported by CNN, a California Safe Drinking Water and Toxic Enforcement Act (affectionately referred to as Proposition 65 Prop. 65 in California) bounty hunter with the biblically-themed name of As You Sow has announced that it has served notice on numerous candy companies of impending litigation due to their sale in California of candies with impermissibly high levels of lead and cadmium. As You Sow reports that they have tested numerous candy products and found at least 18 to have excess levels of lead or cadmium.

Those of us practicing in California have for years dealt with lawsuits brought against manufacturers and distributors of innumerable products because they purportedly contained levels of chemicals labeled as hazardous – in excess of the “Maximum Allowable Daily Level” or “No Significant Risk Level” – as identified by the state regulators tasked with applying Prop. 65. When one manufactures or distributes a product found to have such an excess level, the options are to label the products with a “Prop 65 warning,” reformulate the products, or stop selling them in California. Failing to do so results in litigation wherein entities such as As You Sow acting as “private attorneys general” seek an award of civil penalties, injunctive relief and an award of their own attorneys’ fees.

As lead has long been acknowledged to create hazards to some exposed individuals at certain exposure levels, lead has frequently been the target chemical in Prop 65 cases. The alleged exposures can come from ingesting lead or from “dermal absorption” of lead. We have seen cases about lead in women’s jewelry, and lead in herbal supplements. Since lead is a naturally occurring mineral in the Earth’s crust, it is everywhere. And plants that take their nourishment from the soil of the Earth collect measurable levels of lead. Lead is in fruits and vegetables, nuts and berries, and yes even in chocolate. The level of lead content triggering regulatory action in California is 1 part per million.

The result of the frequent litigation over Prop 65 in California has been the proliferation of Prop 65 warnings. California residents see Prop 65 warnings not only on numerous products, but even posted in the lobbies of hotels and office buildings. Californians can rest easier knowing that concerned citizens like As You Sow are working hard to ensure that we will see a Prop 65 warning on some future date on the door at See’s Candies, or on the label of a Hershey Bar or on the box of Godiva truffles.

More Chemicals (DBAs) Slated for Warnings – But Where Will They Put the Warning Labels?

On November 19, 2014, California’s OEHHA will conduct a meeting to determine whether a group of chemicals known as Dibenzanthracenes (DBAs) should be listed as known  to cause cancer. For those of you not familiar with the OEHHA, it describes its authority and function thusly:

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) is the lead agency for the implementation of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The Carcinogen Identification Committee (CIC) advises and assists OEHHA in compiling the list of chemicals known to the State to cause cancer as required by Health and Safety Code section 25249.8. The Committee serves as the State’s qualified experts for determining whether a chemical has been clearly shown through scientifically valid testing according to generally accepted principles to cause cancer.

OEHHA’s treatment of DBAs lends some insight into the workings of this agency with far-reaching authority.  It is OEHHA that mandates the use of the ubiquitous “Prop. 65 Warnings” that adorn products and buildings throughout the Golden State.

First, DBAs are five-ring polycyclic aromatic hydrocarbons (PAHs) that contain an anthracene core (three linear benzene rings). DB[a,h]A has been listed by Prop. 65 since 1988.  The same chemical was listed as “probably carcinogenic to humans” by the International Agency for Research on Cancer in 1987.  The National Toxicology Program classified DB[a,h]A as “reasonably anticipated to be a human carcinogen” in its Second Report on Carcinogens in 1981, and the U.S. Environmental Protection Agency listed it as a “probable human carcinogen” based on experimental animal evidence.   But none of these authorities have so listed DB[a,c]A or DB[a,j]A, which OEHHA now proposes to add to its list of carcinogens.

Like many other PAHs, DBAs are produced as products of incomplete combustion or pyrolysis of organic matter (e.g., cigarette and marijuana smoke, gasoline engine exhaust, and industrial emissions such as fuel combustion, coke oven operations, and coal-tar distillation) and during high temperature cooking (e.g., grilling, broiling, roasting, baking, frying).  DBAs are known to be included in the smoke of forest fires and even the campground fires one might use to toast marshmallows.

With the exception of smokers and occupationally exposed workers, most individuals are exposed to PAHs predominately from dietary sources.  DBAs are present in the air (ambient and indoor, in occupational settings and cooking fumes); in water (drinking and fresh); in dried sediments; and in food (fresh and cooked).  OEHHA reports that DBAs are present in cigarette smoke and marijuana smoke, slightly more so in marijuana smoke (0.00115 μg/ tobacco  cigarette; 0.00141 μg/ marijuana cigarette ).

DBAs have been aggressively studied for decades.  OEHHA has a page on its website titled “Evidence on the Carcinogenicity of Dibenzanthracenes,”  which has a section of references covering 10 pages.  Despite that, OEHHA notes that “[n]o data on the long-term effects of human exposure to pure DBAs were identified in the literature search conducted by OEHHA” and that “[n]o epidemiology studies were identified that investigated the risk of cancer associated with exposure specifically to DBAs.”  Nevertheless, relying on animal studies, in vivo studies and mechanistic analyses, OEHHA proposes to list the chemicals found in marijuana smoke, fresh vegetables and forest fire smoke as having been “clearly shown through scientifically valid testing according to generally accepted principles to cause cancer.”

Perhaps such a determination can be justified, but where will they put the warning labels?

PS – At the same November meeting, OEHHA will consider expanding its listing of N- nitrosomethyl-n-alkylamines (NMAs).  According to OEHHA, NMAs have been detected in personal care products, such as shampoos and conditioners, and household cleaning products, such as dishwashing liquids and surface cleaners. NMAs are not intentionally added to these products, but may form as a result of the reaction of nitrite with amine compounds.  However, the challenge as to locating warning labels on these products is perhaps somewhat lesser than that relating to DBAs.

The public has until October 13 to comment on two hazard identification documents: “Evidence on the Carcinogenicity of Dibenzanthracenes” and “Evidence on the Carcinogenicity of N-Nitrosomethyl-n-alkylamines.”