California Proposition 65: Scientific, Regulatory and Legal Issues Impacting the Food Industry James R. Coughlin, Ph.D. President, Coughlin & Associates Aliso Viejo, California [email protected]www.linkedin.com/in/jamescoughlin Northern California IFT Pleasanton, CA May 3, 2011
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California Proposition 65: Scientific, Regulatory and Legal Issues Impacting the Food Industry
James R. Coughlin, Ph.D.President, Coughlin & Associates
Presentation Outline What is Proposition 65? Historical Background - General provisions of the law and regulations Early scientific and regulatory landscape
Focus on food issues - Federal preemption efforts and regulations Key exemptions and challenges Prevention of listings Food cases through the years Update on recent activities
Acrylamide in foods/beverages – biggest food issue yet! What should food companies be doing? What is the prognosis for foods “surviving” Prop 65?
Originators: Environmental Defense Fund, Sierra Club and Natural Resources Defense Council, led by Carl Pope and David Roe; key politicians and celebrities were signatories.
Campaign Theme: "Yes on 65! Get Tough on Toxics"
Opponents: Major corporations and agricultural interests allied under California Against the Toxics Initiative.
Overview of Proposition 65 Initiative: law was passed by voter initiative with a 67% vs. 33% margin Exposures: this right-to-know law is concerned only with Carcinogens Developmental and Reproductive Toxicants (DARTs)
Prohibition: prohibits the discharge of any listed chemical into “sources of drinking water” within the state if safe levels are exceeded
Warnings: required on consumer products and in occupational & environmental settings, if calculated safe risk levels are exceeded
Enforcement: burden of proof was shifted to defendants “60-Day Notices” / lawsuits by state and local government
attorneys Private citizen (“bounty hunter”) notices/lawsuits, in which such
plaintiffs can receive 25% of monetary penalties of $2,500 per day per violation. A violation is EVERY package sold!
Carcinogen "No Significant Risk Levels"Language of the Act:"...the exposure poses no significant risk assuming lifetime exposure at the level in question..."
Language of the Implementing Regulations:"...the risk level which represents no significant risk shall be one which is calculated to result in one excess case of cancer in an exposed population of 100,000 assuming lifetime exposure at the level in question..."
Practical Implications of the NSRL:Dose-response assessment is conducted to determine the "no significant risk level" associated with a cancer riskof one in 100,000 or 10-5
“Maximum Allowable Dose Level” for DARTs Determine the “No Observable Effect Level” from animal or
human studies, then divide by factor of 1000 to determine the “Maximum Allowable Dose Level” [MADL]
Reduced Uncertainty and Safety Factors are being used elsewhere, when the data quality are good and when toxicokinetics and toxicodynamics of the chemical are known
The 1000-fold factor is no longer scientifically defensible, and it demands a reappraisal!!
Problems with an advancing science locked into law
BUT, such a change would require a two-thirds vote in the Legislature, and that is extremely unlikely.
Practical Implications of “Safe Harbor” Levels NSRLs and MADLs are formally adopted by the state after public
input; they are often extremely low (Pb = 0.5 μg/day) (acrylamide = 0.2 μg/day)
No “safe harbor” level is established for about 2/3 of the chemicals
Businesses must develop their own NSRLs / MADLs, if no safe harbor level exists (requires detailed risk assessments)
Businesses can also develop alternative NSRLs / MADLs (higherthan safe harbor levels), if they can be shown to be scientifically valid; but they can be challenged by the AG and plaintiff attorneys
In reality, at settlement negotiations, it’s often the mere detectionof a chemical that will subject you to the need to warn.
The “Dreaded” 60-Day Notice“Citizen suit” or “bounty hunter” mechanism is used to initiate a Prop 65 lawsuit
(1) The private party must give notice to the alleged violator and put all of the relevant public prosecutors on notice, triggering a 60-day period in which these public prosecutors may file their own actions against the alleged violator
(2) If no public prosecutor decides to file an action, then the private plaintiff may proceed with the suit
(3) Recently, the law was amended to require that “Certificates of Merit” accompany the notices.
Key Legal Facts to Date No industry has been spared: over 4,000 defendants, over 25,000 claims
against business, > 99% are settled before trial
2009 – 321 settlements, total $14.6 million, $9 million bounty hunters: Private plaintiff - metals in herbal supplements - $682,500 AG - lead in toys - $1,000,000
Totals from 2000 - 2009: $129 million, about $70,000 per settlement 1,850 settlements: legal fees = $81 million, civil penalties = $19
million
2010 – $2.65 million settlement with the Orange County District Attorney by Irwin Naturals (lead in dietary supplements)
The Prop 65 “Game” -Plaintiffs’ Attorneys vs. Manufacturers
Step 1: A plaintiff’s attorney simply must think about a product and then show that a listed chemical is present in the product.
Step 2: The plaintiffs’ attorney then sends a “60-Day Notice” to the company (copying the Attorney General) threatening to sue.
Step 3: Burden of proof is on the company to show that the level of a chemical does not exceed either: (1) the “safe harbor” level set by regulation, or (2) a “no significant risk level” for a carcinogen or a “maximum allowable dose level” for a DART determined by the company itself.
Step 4: Lots of discussions and maneuverings by both parties…and with legal and scientific consultants…until:
Mechanisms for Listing Chemicals “State’s Qualified Experts” (Section 25305) -- Science Advisory Board can decide that a chemical has been “clearly shown through scientifically valid testing according to generally accepted principles to cause cancer or reproductive toxicity.”
Authoritative Bodies (Section 25306) -- automatically listed if a body considered to be authoritative by the state’s qualified experts has formally identified it as causing cancer or reproductive toxicity.
State or Federal Agency (Section 25902) -- a chemical is listed if an agency has formally required it to be labeled or identified as causing cancer or reproductive toxicity.
Foods (and dietary supplements) are UNDER SIEGE for the past several years by the California Attorney General and bounty hunter attorneys
Prop 65 focus is on the presence of INDIVIDUALfood and supplement chemicals, not on the safety or benefits of the WHOLE Product…nor about real HARM to people!
“World According to Roe”Interview in Prop 65 Clearinghouse Magazine(Nov 15 & Dec 15, 2004 issue)
David Roe drafted the Prop 65 initiative in 1986 as an attorney with the Environmental Defense Fund. He thought up the legal content, what kind of mechanisms a new law would use, and what it would target, and then sought influential supporters
“This goes back to the precautionary principle, about that whole idea of modern toxics regulation, which is not to wait until there are dead bodies and tumors, but to create some ability to protect ourselves up front…”
He wanted “…a disclosure law instead of any ban, a burden-of-proof shift, and a way to take the science, which had been stuck for so long, and get all sides to want to unstick it.”
The Food “World According to Roe” He identified the food industry as “the most strenuous
pushers” of federal preemption, because “…federal law had lots of holes in it. Industry knew where those holes were, and they didn’t want those holes to become visible.”
“One thing about meat is that there is a separate federal statute that gives the USDA much closer to exclusive control over meat. So there’s a very separate, significant legal issue about whether meat is handled differently and what the state’s potential role is in regulating toxic chemicals in meat products, as opposed to other food products.”
Notable Food Issues under Prop 65Reference: AG’s letter Sept 2003 to the House of Representatives, opposing the “National Uniformity for Food Act of 2003”
Leaded crystal (1991): warnings required
Lead foil wine bottle caps (1991): vintners switched after warnings were required
Lead in ceramic tableware (1992): warnings required, then FDA set new action levels
Alcoholic beverages for pregnant women: prior to FDA warnings, California required warnings where alcohol was sold/consumed.
Meat Industry Wins Federal Preemption In 1987, then USDA Secretary Richard Lyng wrote to the Governor
expressing USDA’s view that the Federal Meat Inspection Act of 1906 preempted Prop 65; USDA “owns the label”
In Nov. 2004, “60-Day Notices” were filed by Dr. Whitney Leeman (an environmental engineer) against grocery retailers and meat companies, for not providing label warnings about dioxins (carcinogens) and PCBs(carcinogens & DARTs) in ground beef and beef liver
American Meat Institute and National Meat Assn. sued Leeman first in San Diego Superior Court (May 2005); the “twist” here was that industry initiated the litigation themselves, not waiting for Leeman to sue, rather than raising preemption as a defense. Industry won, but there was an appeal
In December 2009, a California Court of Appeal granted a victory to the meat industry, declaring that there is an express Federal Preemption for packages at point of sale, so no warning requirement. Issue of whether Federal law preempts Prop 65 for food service meats was not adjudicated.
PhIP is a heat-produced heterocyclic amine; court had ruled there was a preemption
Appellate Court decided no federal preemption for grilled chicken sold in restaurants
The court ruled that the Poultry Product Inspection Act “does not preempt the Safe Harbor Warning, because there is no conflict between the warning and any federal policy concerning chicken.”
Safe harbor warning is “presumptively clear and reasonable.”
Section 25900. Use of Specified Methods of Detection and Analysis as a Defense to an Enforcement Action In February 2005, OEHHA proposed a revised regulation after
years of legal debate on the existing regulation and then adopted the current regulation in April 2006
The method of detection and analysis must be conducted by a laboratory certified or accredited by the State, a federal agency, the National Environmental Laboratory Accreditation Program or similar nationally recognized accrediting organization
Defendant must use a method of detection and analysis either: required by their permit to be used for detecting or
measuring the chemical in question in the relevant matrix; or must use the most sensitive method of detection and
Section 25703 contains the “Cooking Exemption” for certain kinds of food chemicals (carcinogens only, not for DARTs) Where chemicals in food are produced by cooking
necessary to render the food palatable or to avoid microbiological contamination
In these cases, there can be an allowance for a higherNSRL, i.e., an “alternative risk level”, if it can be supported by “sound considerations of public health” (but this is very difficult to achieve)
Where chlorine disinfection is necessary to comply with sanitation requirements, even though a listed chemical may be formed (e.g., disinfection byproducts).
Chemicals are regulated not on concentration levels, but on the amount consumed (μg/day) from a product
Must determine intakes by actual eaters, not per capita: Nationwide databases (CSFII, NHANES); limited California data Individual company (or specific industry) marketing data
e.g., Apple juice (with 0.8 ppb Pb); MADL = 0.5 μg Pb/day
If the average consumer drinks 0.5 liters/day => exposure = 0.4 μg Pb/day (below the MADL)
But if the average consumption is 0.7 liters/day: Exposure = 0.56 μg Pb/day Over the MADL, and a warning would be required, unless
occurring" carcinogens and DARTs in foods and supplements (soil minerals, fungal toxins, natural pesticides, etc.)
Allows subtracting out the natural background level from the total level in a food or supplement; but only that portion that is not added from “human activity”
But since cooking, heating and processing are considered “human activity,” we have lost our arguments for chemicals produced when humans get involved
Nicolle-Wagner v. Deukmejian et al. (LA County Superior Court, August 1989) challenged this exemption; regulation was upheld, but appealed; Court of Appeal did uphold this exemption.
“…is naturally occurring only to the extent that it was not avoidable by good agricultural or good manufacturing practices.” [Calcium supplements case]
“…shall at all times utilize quality control measures that reduce natural chemical contaminants to the ‘lowest level currently feasible’…”
Problems: how to distinguish “natural” from “man-made” exposures (lead from soil vs. processing contamination)? Very expensive analytical undertaking and a continuing scientific and legal battleground.
Industrial chemical listed in 1990 as a carcinogen
NSRL set by Prop 65 = 0.2 μg/day
Uses: polyacrylamide gels (labs for separating proteins, grouting, flocculants for purifying water)
Discovered by the Swedes in 2002 in hundreds of heat-processed food products making up about 40% of our calories; mainly formed by Maillard Browning Reaction between glucose / fructose and asparagine.
Acrylamide Facts under Prop 65 For each food product with any detectable level (5-10 ppb), a daily 1-
ounce serving exceeds the NSRL and require a cancer warning label
Battleground: several fast-food restaurants (French fries) & potato chip manufacturers were sued in 2002 by “bounty hunter” attorneys, because no warnings were being given
Food industry urged the State not to require warnings on any foods until the developing global science determines the true risk of acrylamide to human health
Industry fought hard for a higher NSRL, but lost on this, and we also lost on our arguments for the “naturally occurring” and “cooking” exemptions
August 2005: California Attorney General picked up these suits demanding cancer warnings on these products.
Acrylamide Facts under Prop 65 AG sued in 2005 and settled in 2008 with Heinz (Ore-Ida) frozen
fries/tater tots for $600,000 and demanded a 50% reduction in levels
AG sued then settled in 2008 with Frito-Lay/others on potato chips; agreed to cut levels to 281 ppb by summer 2011 (20 - 85% reductions) to avoid warnings; Frito-Lay will have to pay ~ $2 million more if reduction efforts fail
Plaintiffs group sued cereal manufacturers in 2009; case pending
Plaintiffs group sued 11 coffee shop chains in April 2010; additional suits against coffee roasters are anticipated following December 2010 60-Day Notices to All the major manufacturers
Lead in Chocolate Case American Environmental Safety Institute v. Mars et al., over
the failure to warn about lead (Pb) in chocolate products
Chocolate manufacturers compiled evidence showing that the products met the “Naturally Occurring” exemption: Pb is present in soil where the cocoa is grown No Pb-based chemicals are used on cocoa plants Cocoa is farmed far from sources of Pb pollution Pb levels in the beans are reduced successively in processing Pb in the product is isotopically consistent with geologic Pb
Case was dismissed in Dec 2003; plaintiff’s attorney accepted a nuisance value settlement just before trial.
AG sued the 3 largest tuna canning companies (June 2004) alleging failure to warn consumers about mercury risks
Tuna companies filed motion to dismiss based on federal preemption arguments; they were determined to fight warning labels on their cans
2006, Superior Court ruling in favor of the industry: Prop 65 warnings would conflict with federal law Mercury exposures were < 0.3 µg/day (below companies’ MADL) Most methylmercury was declared to be “naturally occurring”
PCBs in Fish Oil Supplements March 2010, private plaintiffs sued 6 dietary supplement
companies and 2 pharmacy chains, alleging exposures to PCBs in fish/shark oil and liver oil supplements
PCBs are listed as carcinogens and developmental toxicants
Carcinogen NSRL for PCBs = 0.09 µg/day; but there is no MADLadopted for developmental toxicity
In the press, plaintiffs attorneys have claimed that the appropriate MADL is significantly lower than the carcinogen NSRL, but the MADL is probably higher (based on monkey studies)
4-Methylimidazole (4-MEI) Maillard Browning Reaction compound proposed for listing as a
carcinogen by “Authoritative Bodies” mechanism (based on NTP bioassay) in Jan. 2008; it was finally listed in Jan. 2011 after a 3-year battle waged by industry
Occurs naturally in added caramel colors (cola beverages, darker beers, other beverages) and in many Maillard-browned foods/beverages, including coffee
NTP cancer bioassay showed increases only in lung tumors in mice, but it reduced many other tumors in rats; this made no difference to OEHHA
OEHHA will soon finalize a regulation to establish the NSRL = 16 µg/day; impossible for most products to stay below this level
“Labor Code” (Sections 6382[b][1] and [d]) – Certain animal and human carcinogens and reproductive toxicants identified by IARC and NTP are required to be listed; Governor’s Initial List used LC mechanism
OEHHA began using LC to list chemicals automatically in 2004, after not using this mechanism for 17 years; this mechanism allows zero discussion of the science!
Sierra Club and other activist groups sued the state in Nov. 2007 over several causes of action, including demand to list at least 92 LC substances, some being food chemicals; case currently at Appellate Court in SF.
Styrene Court Decision: IARC “Group 2B” Substances Cannot be Listed if Limited Evidence Styrene industry sued the state in June 2009 to prevent Labor Code
listing, because styrene is IARC Group 2B, “limited evidence” in animals and humans…and they won!
Vinyl acetate industry also won, because of “inadequate evidence” in humans and “limited evidence” in animals
Neither chemical showed “sufficient evidence;” the “limited evidence” does not rise to “known to the state to cause cancer”
The state appealed, currently at Appellate Court in Sacramento
Still to be tested: should other substances listed as IARC Group 2B (based only on limited evidence) also get to avoid listing?
In the last 4 years, there have been over 230 60-day notices involving lead and other heavy metals in dietary supplements, including herbals
In 2008, the AG sued 54 dietary supplement companies for lead in multi-vitamins and other products, and at least 7 other actions are pending
In 2010-2011, new plaintiff, Environmental Research Center, has issued over 200 “60-Day Notices” regarding lead and other heavy metals in dietary supplements; also many notices for diet shakes, protein powders and nutrition bars
Other “Hot” Food Issues BPA was not listed by DART Committee July 2009; activists’ petition now
being reviewed to list BPA based on NTP-CERHR as the AB
Since Sept 2007, “added” caffeine (in colas, energy drinks, other soft drinks, supplements) is facing possible listing as a DART
3-MCPD and 1,3-DCP (in hydrolyzed protein ingredients, soy sauce) listed in September 2010 as carcinogens by the Carcinogen Identification Committee
2011 Listings to date – Malonaldehyde – carcinogen listed April 29 based on 1988 NTP rat study Salted fish, Chinese style – listed May 3 based on IARC “human
carcinogen” classification
Proposed DART listing of Sulfur Dioxide, an air pollutant, but some sulfite studies were cited as evidence; sulfites as food preservatives?
Prop 65 Compliance StrategyStep 1: Determine what operations/products are subject to Prop 65
Step 2: Identify potentially exposed persons (workers and consumers) and prohibited discharges (if you have plants in California)
Step 3: Assess whether risks to exposed persons are "significant" or whether discharges are in a "significant" amount
Step 4: Devise a compliance strategy to provide "clear & reasonable warnings" (if necessary) to consumers and to address prohibited discharges to drinking water
Step 5: Establish an ongoing monitoring system for Prop 65 regulatory developments and new chemical listings.
Conclusions on Prop 65 and Foods Prop 65-listed chemicals ARE in the foods and beverages you
manufacture, as well as in your California workplaces
We in the industry thought for almost 20 years that we would be able to avoid warnings on our products indefinitely by scientific diligence, hard legal / regulatory work and some measure of “good luck.”
Chocolate was a nice victory. But the industry suffered its first losses on retail fish and French fries warnings, and we are now fighting for our lives over acrylamide warnings on food products
I believe today that NO cancer or birth defects warnings are scientifically justified on any foods…in California or elsewhere
Prognosis for Foods and Supplements? Stakes are very high!! Bounty hunters are thriving; our products are
under increasing pressure; financial health of companies is being challenged; credibility of federal government regulatory agencies is also under attack
Industry chemists, toxicologists, lawyers, regulatory affairs specialists & product developers must increase their focus
Keep chemicals & ingredients from being listed in the first place! Watch IARC and NTP (as Authoritative Bodies) very carefully!
I firmly believe that NO cancer or birth defects warnings are scientifically justified on any foods/supplements in California
Safety of the whole product, not individual chemicals one-by-one, is what should be assessed; but Prop 65 does not allow for that!