California Proposition 65: Scientific,Regulatory and Legal Issues Impactingthe Food Industry   James R. Coughlin, Ph.D.   ...
Presentation Outline        What is Proposition 65?        Historical Background -              General provisions of t...
© 2011 Coughlin &Associates
Ballot Initiative                    “Safe Drinking Water and Toxic                      Enforcement Act of 1986”    Orig...
Proposition 65 -- Why Did It Pass?        Perceived ineffectiveness of federal and state anti-         pollution laws    ...
New Paradigm -- Shift in the Burden of Proof to Manufacturers     From the prosecutor or plaintiff to the defendant compa...
Overview of Proposition 65   Initiative: law was passed by voter initiative with a 67% vs. 33% margin   Exposures: this ...
Implementation by the State:       Appears in California law as Health and Safety Code        Sections 25249.5 through 25...
What Does Prop 65 Prohibit?       Discharging listed chemicals into        “sources of drinking water” in        Californ...
To Whom Does Prop 65 Apply?   Companies doing business in California      If a product is sold in California, then it mu...
Major Provisions of Proposition 65   Hazard Identification of Chemicals   Warnings and Discharge Prohibitions   Enforce...
What Kind of Exposures?   “Knowingly and intentionally expose”   Exposures can occur by:         Consumer product expos...
“Clear and Reasonable Warnings”   Required by Prop 65     Occupational / Environmental Exposures –       “WARNING: This ar...
“Clear and Reasonable Warnings”   Required by Prop 65      Consumer Products -      “WARNING: This product contains a che...
Exceptions to Warning Requirement   Exposure at levels that present “no significant risk” of cancer   Exposure at levels...
Hazard Identification and Risk Assessment    “Governor’s List” of chemicals:        Carcinogens -           NSRLs = No ...
Over 500 Carcinogens               No Significant Risk Level [NSRL] = (1 x 10-5)            Over 300 Reproductive Toxicant...
Carcinogen "No Significant Risk Levels"  Language of the Act:  "...the exposure poses no significant risk assuming lifetim...
“Maximum Allowable Dose Level” for DARTs    Determine the “No Observable Effect Level” from animal or     human studies, ...
“The Dose Makes the Poison”“All things are poison and there is nonewhich is not a poison. Solely the dosedifferentiates a ...
© 2011 Coughlin &Associates
© 2011 Coughlin &Associates
Practical Implications of “Safe Harbor” Levels    NSRLs and MADLs are formally adopted by the state after public     inpu...
The “Dreaded” 60-Day Notice     “Citizen suit” or “bounty hunter” mechanism is used to     initiate a Prop 65 lawsuit     ...
60-Day Notices                    Lead (Pb)               Other Chemicals Brass faucets and keys               Toluene in ...
Key Legal Facts to Date   No industry has been spared: over 4,000 defendants, over 25,000 claims    against business, > 9...
The Prop 65 “Game” -    Plaintiffs’ Attorneys vs. Manufacturers     Step 1: A plaintiff’s attorney simply must think about...
Mechanisms for Listing Chemicals   “State’s Qualified Experts” (Section 25305) -- Science Advisory   Board can decide that...
Five Prop 65 “Authoritative Bodies”  International Agency for Research on Cancer (IARC)  U.S. National Toxicology Program ...
Major Problems for Foods Today:    Foods (and dietary supplements) are UNDER     SIEGE for the past several years by the ...
“World According to Roe”        Interview in Prop 65 Clearinghouse Magazine        (Nov 15 & Dec 15, 2004 issue)        D...
The Food “World According to Roe”      He identified the food industry as “the most strenuous       pushers” of federal p...
Food & Supplement-related Chemicals         Heavy Metals - arsenic, lead, cadmium, mercury         Organic Solvents - chlo...
Notable Food Issues under Prop 65   Reference: AG’s letter Sept 2003 to the House of Representatives,   opposing the “Nati...
Notable Food Issues (cont’d)       Arsenic in bottled water (2000); settlement reduced        arsenic levels to < 5 ppb  ...
Attempts at Federal Preemption     Prop 65 has been upheld against numerous legal      challenges over the years     In ...
Meat Industry Wins Federal Preemption    In 1987, then USDA Secretary Richard Lyng wrote to the Governor     expressing U...
Sodium Nitrite Listing Challenge    April 1998 – OEHHA requested information on 15 chemicals, including     nitrite, for ...
PhIP Ruling – Grilled Chicken       PhIP is a heat-produced heterocyclic amine; court had ruled        there was a preemp...
Food Regulations Under Prop 65:Key Exemptions and Challenges© 2011 Coughlin &Associates
Section 25900. Use of Specified Methods of  Detection and Analysis as a Defense to an  Enforcement Action      In Februar...
“Cooking” and “Chlorine Disinfection”  Exemptions       Section 25703 contains the “Cooking Exemption” for certain       ...
Question of “Averaging” Exposures      For carcinogens only, allowed to average exposures over a 70-year       lifetime b...
Determining Exposure Levels by Consumption Rates      Chemicals are regulated not on concentration levels, but on the    ...
"Naturally Occurring" Exemption       Section 25501: regulation adopted in 1989 exempting "naturally        occurring" ca...
"Naturally Occurring" Exemption       “…is naturally occurring only to the extent that it was not        avoidable by goo...
Acrylamide Snapshot: Chemistry and Toxicology Occupational neurotoxin in humans, genotoxic / mutagenic in cell cultures ...
Acrylamide Facts under Prop 65    Industrial chemical listed in 1990 as a carcinogen    NSRL set by Prop 65 = 0.2 μg/day...
Food                           Acrylamide Range (ppb)Baby food/biscuits                     ND - 442Breads/bakery products...
Food                         Acrylamide Range (ppb)French fries                        117 - 1325Fruits/vegetables (canned...
Acrylamide Facts under Prop 65    For each food product with any detectable level (5-10 ppb), a daily 1-     ounce servin...
Acrylamide Facts under Prop 65    AG sued in 2005 and settled in 2008 with Heinz (Ore-Ida) frozen     fries/tater tots fo...
What is the standard for lead?   Problem with uncertain standards for naturally occurring lead    in dietary supplements:...
Lead in Chocolate Case     American Environmental Safety Institute v. Mars et al., over      the failure to warn about le...
Mercury in Fish Cases – Fresh Fish     Retail grocery stores (fresh fish aisle):        AG sued in 2003 for failure to w...
Mercury in Fish Cases – Canned Tuna    AG sued the 3 largest tuna canning companies (June 2004)     alleging failure to w...
PCBs in Fish Oil Supplements   March 2010, private plaintiffs sued 6 dietary supplement    companies and 2 pharmacy chain...
Lead (Pb) in Apple & Grape Juices, PackagedPeaches & Pears and Fruit Cocktail   June 9, 2010, the Environmental Law Found...
4-Methylimidazole (4-MEI)   Maillard Browning Reaction compound proposed for listing as a    carcinogen by “Authoritative...
“Labor Code” Listing Mechanism - Legal Battle     “Labor Code” (Sections 6382[b][1] and [d]) – Certain animal      and hu...
Styrene Court Decision: IARC “Group 2B” SubstancesCannot be Listed if Limited Evidence Styrene industry sued the state in...
Dietary Supplements and Lead   In the last 4 years, there have been over 230 60-day notices    involving lead and other h...
NTP -- Supplement Ingredients     Substance            Levels of          Technical      Likely to be                     ...
NTP -- Supplement Ingredients     Substance            Levels of            Technical      Likely to be                   ...
NTP -- Food Ingredients        Substance            Levels of          Technical    Likely to be                          ...
Other “Hot” Food Issues    BPA was not listed by DART Committee July 2009; activists’ petition now     being reviewed to ...
Food Warnings – Regulatory Update Project    Section 25601 – discussion of a Safe Harbor program for warnings for     exp...
PROP 65…             PRODUCT COMPLIANCE© 2011 Coughlin &Associates
Strategies For On-Going Prop 65    Compliance Monitoring          Programmed monitoring of key          ingredients for l...
Prop 65 Compliance Strategy   Step 1: Determine what operations/products are subject to Prop 65   Step 2: Identify potenti...
Characterize Your Products       Identify major ingredients       Develop matrix of ingredients common to multiple produ...
Steps for Product-Specific     Dietary Exposure Assessment                   Monitor Prop 65 activities very closely     ...
Conclusions on Prop 65 and Foods       Prop 65-listed chemicals ARE in the foods and beverages you        manufacture, as...
Prognosis for Foods and Supplements?    Stakes are very high!! Bounty hunters are thriving; our products are     under in...
Coughlin_NorCal IFT_Proposition 65_May 2011
Coughlin_NorCal IFT_Proposition 65_May 2011
Coughlin_NorCal IFT_Proposition 65_May 2011
Coughlin_NorCal IFT_Proposition 65_May 2011
Coughlin_NorCal IFT_Proposition 65_May 2011
Coughlin_NorCal IFT_Proposition 65_May 2011
Coughlin_NorCal IFT_Proposition 65_May 2011
Coughlin_NorCal IFT_Proposition 65_May 2011
Coughlin_NorCal IFT_Proposition 65_May 2011
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Coughlin_NorCal IFT_Proposition 65_May 2011

  1. 1. California Proposition 65: Scientific,Regulatory and Legal Issues Impactingthe Food Industry James R. Coughlin, Ph.D. President, Coughlin & Associates Aliso Viejo, California jrcoughlin@cox.net www.linkedin.com/in/jamescoughlin Northern California IFT Pleasanton, CA May 3, 2011
  2. 2. 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?© 2011 Coughlin &Associates
  3. 3. © 2011 Coughlin &Associates
  4. 4. Ballot Initiative “Safe Drinking Water and Toxic Enforcement Act of 1986”  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. Campaign Theme: "Too Many Exemptions“  Passed by California voters (63 vs. 37%) in November 1986© 2011 Coughlin &Associates
  5. 5. Proposition 65 -- Why Did It Pass?  Perceived ineffectiveness of federal and state anti- pollution laws  Simple, straightforward presentation of the "Safe Drinking Water Initiative" concept; it did not look controversial  Endorsements by celebrities and opinion leaders  Inability or unwillingness of the public to understand complex technical/economic issues of chemical regulation  Community “right-to-know” laws were evolving elsewhere (e.g., New Jersey).© 2011 Coughlin &Associates
  6. 6. New Paradigm -- Shift in the Burden of Proof to Manufacturers  From the prosecutor or plaintiff to the defendant company exposing people or the environment to the listed chemicals  This is an alteration in the traditional legal requirement that the prosecutor or plaintiff initiate the action to show harm  Prop 65 is NOT about harm, just about giving warnings to consumers and workers and prohibiting discharges to the environment© 2011 Coughlin &Associates
  7. 7. 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!© 2011 Coughlin &Associates
  8. 8. Implementation by the State:  Appears in California law as Health and Safety Code Sections 25249.5 through 25249.13  Regulations are in California Code of Regulations, Title 27  California Regulatory Notice Register - published every Friday, it is the official implementation site  California Attorney General’s Office  http://ag.ca.gov/prop65/  Office of Environmental Health Hazard Assessment (OEHHA) within California EPA –© 2011 Coughlin & http://oehha.ca.gov/prop65.htmlAssociates
  9. 9. What Does Prop 65 Prohibit?  Discharging listed chemicals into “sources of drinking water” in California  Exposing consumers and workers in California to listed chemicals without a prior warning.© 2011 Coughlin &Associates
  10. 10. To Whom Does Prop 65 Apply? Companies doing business in California  If a product is sold in California, then it must comply with Prop 65 (entire distribution chain – manufacturers, distributors, retailers)  California manufacturing plants that expose their workers or neighbors The only exemptions are:  Companies with fewer than 10 employees  Governmental units do not need to comply  Anyone operating a public water system© 2011 Coughlin &Associates
  11. 11. Major Provisions of Proposition 65  Hazard Identification of Chemicals  Warnings and Discharge Prohibitions  Enforcement Actions© 2011 Coughlin &Associates
  12. 12. What Kind of Exposures? “Knowingly and intentionally expose” Exposures can occur by:  Consumer product exposure  Environmental exposure  Occupational exposure© 2011 Coughlin &Associates
  13. 13. “Clear and Reasonable Warnings” Required by Prop 65 Occupational / Environmental Exposures – “WARNING: This area contains a chemical known to the State of California to cause cancer [or birth defects or other reproductive harm].” - Workplace signs, HAZCOM, newspaper ads© 2011 Coughlin &Associates
  14. 14. “Clear and Reasonable Warnings” Required by Prop 65  Consumer Products - “WARNING: This product contains a chemical known to the State of California to cause cancer [or birth defects or other reproductive harm].”  Restaurants - “WARNING: Chemicals known to the State of California to cause cancer, or birth defects or other reproductive harm may be present in foods or beverages sold or served here.”© 2011 Coughlin &Associates
  15. 15. Exceptions to Warning Requirement Exposure at levels that present “no significant risk” of cancer Exposure at levels less than 1/1000 of the “no observable effect level” for DARTS (the 1000-fold safety factor) Waiting period between official listing of the chemical and enforcement: 12 months for exposures, 20 months for discharges If Federal law governs warning in a manner that preempts state authority “Naturally occurring” exemption© 2011 Coughlin &Associates
  16. 16. Hazard Identification and Risk Assessment  “Governor’s List” of chemicals:  Carcinogens -  NSRLs = No Significant Risk Levels  Developmental and Reproductive Toxicants (DARTs) -  MADLs = Maximum Allowable Dose Levels  Must determine whether calculated safe levels of listed chemicals are being exceeded in products, and if so, provide a warning to consumers.© 2011 Coughlin &Associates
  17. 17. Over 500 Carcinogens No Significant Risk Level [NSRL] = (1 x 10-5) Over 300 Reproductive Toxicants [DARTs] MADL = No Observable Effect Level 1000 Exposure (µg/day), Not Concentration!© 2011 Coughlin &Associates
  18. 18. 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 risk of one in 100,000 or 10-5© 2011 Coughlin &Associates
  19. 19. “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.© 2011 Coughlin &Associates
  20. 20. “The Dose Makes the Poison”“All things are poison and there is nonewhich is not a poison. Solely the dosedifferentiates a poison from a remedy.” Paracelsus (1493-1541)© 2011 Coughlin &Associates
  21. 21. © 2011 Coughlin &Associates
  22. 22. © 2011 Coughlin &Associates
  23. 23. 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 (higher than 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 detection of a chemical that will subject you to the need to warn.© 2011 Coughlin &Associates
  24. 24. 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.© 2011 Coughlin &Associates
  25. 25. 60-Day Notices Lead (Pb) Other Chemicals Brass faucets and keys Toluene in nail polish Leaded crystal, goblets Fumes from candles PC tool kit with solder Play box sand (silica) Dinnerware, mugs Environmental tobacco smoke Traffic crossing buttons, light Carbon monoxide in parking bulbs, holiday string lights garages Stain glass lamps and other PVC-coated cables, locks, artistic/decorative items exercise weights, rainwear Wristwatch bands, jewelry Solvents in spray paints/strippers Foods/supplements© 2011 Coughlin & DEHP in vinyl placematsAssociates
  26. 26. 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) Safe drinking water and environmental pollution are barely ever addressed!!!© 2011 Coughlin &Associates
  27. 27. 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: - Settlement…Or You’re Off to Court!!© 2011 Coughlin &Associates
  28. 28. 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.© 2011 Coughlin &Associates
  29. 29. Five Prop 65 “Authoritative Bodies” International Agency for Research on Cancer (IARC) U.S. National Toxicology Program (NTP) U.S. Environmental Protection Agency (EPA) U.S. Food and Drug Administration (FDA) U.S. National Institute of Occupational Safety and Health (NIOSH)© 2011 Coughlin &Associates
  30. 30. Major Problems for Foods Today:  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 INDIVIDUAL food and supplement chemicals, not on the safety or benefits of the WHOLE Product…nor about real HARM to people!© 2011 Coughlin &Associates
  31. 31. “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.”© 2011 Coughlin &Associates
  32. 32. 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.”© 2011 Coughlin &Associates
  33. 33. Food & Supplement-related Chemicals Heavy Metals - arsenic, lead, cadmium, mercury Organic Solvents - chloroform, methylene chloride, benzene Aldehydes - formaldehyde, acetaldehyde Pesticides - EBDCs, DDTs, fumigants, herbicides, ethylene oxide Mycotoxins - aflatoxins, ochratoxin A, fumonisin Antioxidants - (BHA) and Plasticizers (phthalates) Nitrosamines - Dimethylnitrosamine, nitroso-pyrrolidine Heat-induced carcinogens - PAHs, heterocyclic amines, acrylamide, furan Nutrients - Retinol / retinyl esters (> 10,000 I.U.) Environmental Contaminants - PAHs, asbestos, dioxin, PCBs© 2011 Coughlin &Associates
  34. 34. Notable Food Issues under Prop 65 Reference: 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.© 2011 Coughlin &Associates
  35. 35. Notable Food Issues (cont’d)  Arsenic in bottled water (2000); settlement reduced arsenic levels to < 5 ppb  Since the AG’s letter, fresh fish/canned tuna (mercury) and French fries/potato chips (acrylamide) suits were undertaken and decided  AG noted “Quiet Compliance” without litigation…  Processors eliminated some ingredients (K bromate in bread)  As early as 1988, industry moved away from lead- soldered cans.© 2011 Coughlin &Associates
  36. 36. Attempts at Federal Preemption  Prop 65 has been upheld against numerous legal challenges over the years  In fact, Prop 65 is the only state law specifically exempted from the preemption provision on the 1997 FDA Modernization Act (FDAMA)  The only Prop 65 exceptions to these failed challenges are:  Specific facts related to railroads  Smoking cessation products (nicotine patches), a case won at the California Supreme Court in 2004 by Michele Corash (Morrison & Foerster attorney)  Meat industry challenge© 2011 Coughlin &Associates
  37. 37. 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.© 2011 Coughlin &Associates
  38. 38. Sodium Nitrite Listing Challenge  April 1998 – OEHHA requested information on 15 chemicals, including nitrite, for potential listing as developmental toxicants under the Authoritative Bodies mechanism of listing  June 1998 – AMI submitted written comments to OEHHA  December 1998 – OEHHA published “Notice of Intent to List Sodium Nitrite as a Developmental Toxicant”  February 1999 – AMI-led industry coalition submitted comments objecting to nitrite’s listing on scientific grounds  May 1999 – OEHHA published Notice agreeing with industry that the scientific criteria for listing had not been met, but OEHHA passed the listing decision to the DART Identification Committee (8 scientists)  July-Sept 1999 – OEHHA published “Request for Information” on nitrite, and AMI-led industry coalition submitted written comments  June 2000 – DART Committee (almost unanimously, 23 to 1) voted NOT to list sodium nitrite as a reproductive or developmental toxicant!© 2011 Coughlin &Associates
  39. 39. PhIP Ruling – Grilled Chicken  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.”© 2011 Coughlin &Associates
  40. 40. Food Regulations Under Prop 65:Key Exemptions and Challenges© 2011 Coughlin &Associates
  41. 41. 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 analysis.© 2011 Coughlin &Associates
  42. 42. “Cooking” and “Chlorine Disinfection” Exemptions  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 higher NSRL, 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).© 2011 Coughlin &Associates
  43. 43. Question of “Averaging” Exposures  For carcinogens only, allowed to average exposures over a 70-year lifetime because cancer is a chronic disease  For DARTs, however, exposures exceeding safe intake levels, even on one day of pregnancy, are a violation of the law (no “averaging” is permitted)  For environmental / occupational exposures, even for carcinogens, what do you do with daily spikes or peaks?  For consumer products, what is “average” consumption, who is the “average” California consumer?  Attorney General and plaintiffs argue that ANY exposure to a carcinogen above the “safe harbor” NSRL is a violation of the law.© 2011 Coughlin &Associates
  44. 44. Determining Exposure Levels by Consumption Rates  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 some can be shown to be naturally occurring.© 2011 Coughlin &Associates
  45. 45. "Naturally Occurring" Exemption  Section 25501: regulation adopted in 1989 exempting "naturally 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.© 2011 Coughlin &Associates
  46. 46. "Naturally Occurring" 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.© 2011 Coughlin &Associates
  47. 47. Acrylamide Snapshot: Chemistry and Toxicology Occupational neurotoxin in humans, genotoxic / mutagenic in cell cultures Known rat carcinogen, classified as “probable human carcinogen” Metabolized to glycidamide (an epoxide), also an animal carcinogen Acrylamide & glycidamide can bind to DNA, amino acids and proteins  DNA adducts  carcinogenic potential  Blood hemoglobin adducts  biomarker of exposure  Dietary proteins may reduce acrylamide uptake in humans  Protective enzymes can detoxify acrylamide and glycidamide NTP Acrylamide Bioassay in rats and mice (April 5, 2011) – “Clear Evidence of Carcinogenicity” However, human epidemiology evidence shows little or no risk.© 2011 Coughlin &Associates
  48. 48. Acrylamide Facts under Prop 65  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.© 2011 Coughlin &Associates
  49. 49. Food Acrylamide Range (ppb)Baby food/biscuits ND - 442Breads/bakery products ND - 364Cereals 11 - 1057Chocolate products ND - 909Coffee (roasted, not brewed) 37 - 374Coffee (brewed) 5 - 11Cookies/crackers 26 - 1540Dairy drinks ND - 43Dried foods/mixes ND - 1184© 2011 Coughlin &Associates
  50. 50. Food Acrylamide Range (ppb)French fries 117 - 1325Fruits/vegetables (canned) ND - 83Gravies/seasonings ND - 151Infant formulas NDNuts/nut butters ND - 457Potato chips 117 - 4080Snacks (other salty) 12 - 1340Olives 123 - 1925Prune juice 53 - 326 © 2011 Coughlin & Associates
  51. 51. 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.© 2011 Coughlin &Associates
  52. 52. 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 --- despite coffee reducing the risk of several human cancers!© 2011 Coughlin &Associates
  53. 53. What is the standard for lead? Problem with uncertain standards for naturally occurring lead in dietary supplements:  Multiple settlements setting “naturally occurring” lead levels  Lead in calcium supplements = 1.5 µg/day (AG’s Settlement 1997-1998)  Now several standards for lead in dietary supplements (4.5 , 2.75 , 0.5 µg/day).© 2011 Coughlin &Associates
  54. 54. 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.© 2011 Coughlin &Associates
  55. 55. Mercury in Fish Cases – Fresh Fish  Retail grocery stores (fresh fish aisle):  AG sued in 2003 for failure to warn shoppers of swordfish, shark, mackerel and tilefish  Birth defects warning signs are now posted as part of the settlement  First ever food warning under Prop 65!  Restaurants:  AG sued in 2003 for failure to warn; 2005 settlement:  Signs must be posted warning pregnant women and children not to eat these fish and to limit tuna intake  Almost $400,000 for civil penalties, consumer education, reimburse AG’s costs.© 2011 Coughlin &Associates
  56. 56. Mercury in Fish Cases – Canned Tuna  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”  AG appealed, but the decision for the industry was upheld.© 2011 Coughlin &Associates
  57. 57. 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 MADL adopted 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) Settlement has been negotiated between the parties.© 2011 Coughlin &Associates
  58. 58. Lead (Pb) in Apple & Grape Juices, PackagedPeaches & Pears and Fruit Cocktail June 9, 2010, the Environmental Law Foundation (ELF) filed “60-Day Notices” on 49 companies for 146 products, including some baby foods [David Roe and James Wheaton] ELF tested 398 samples and claimed that most of the products exceeded the Pb MADL of 0.5 µg/day (for 1 serving) Industry groups have strongly defended the safety of their products in the press, and no lawsuits have yet been filed by ELF FDA has done extensive testing and reported no products posing any health concern.© 2011 Coughlin &Associates
  59. 59. 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 ABA / GMA / CLFP / NCA sued OEHHA in February about the listing.© 2011 Coughlin &Associates
  60. 60. “Labor Code” Listing Mechanism - Legal Battle  “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.© 2011 Coughlin &Associates
  61. 61. Styrene Court Decision: IARC “Group 2B” SubstancesCannot 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?© 2011 Coughlin &Associates
  62. 62. Dietary Supplements and Lead 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© 2011 Coughlin &Associates
  63. 63. NTP -- Supplement Ingredients Substance Levels of Technical Likely to be Evidence Report (TR) Listed?Chromium Picolinate FinalTR-556 E–N–N–N June 2010 NOGinseng DraftTR-567 N–N–N–N Nov 19, 2009 NO Peer ReviewGoldenseal RootPowder C–C–S–N Final YES!!TR-562 August 2010Pulegone DraftTR-563 N–C–C–C Nov 19, 2009 YES!! Peer ReviewMilk Thistle Extract DraftTR-565 N–N–N–N Nov 19, 2009 NO Peer Review “Levels of Evidence” M Rat – F Rat – M Mouse – F Mouse C = Clear S = Some E = Equivocal N = No
  64. 64. NTP -- Supplement Ingredients Substance Levels of Technical Likely to be Evidence Report (TR) Listed? α β-Thujone Yes Mixture S–N–N–N Peer Review No TR-570, Herbal Jan 26, 2011 med, flavorings Yes Kava Kava Extract E–N–C–S Peer Review Yes! TR-571 Jan 26, 2011 Yes Aloe Vera Whole C–C–N–N Peer Review Leaf Extract Apr 5, 2011 Yes! TR-577, Herbal remedy “Levels of Evidence” M Rat – F Rat – M Mouse – F Mouse C = Clear S = Some E = Equivocal N = No© 2011 Coughlin &Associates
  65. 65. NTP -- Food Ingredients Substance Levels of Technical Likely to be Evidence Report (TR) Listed? Cumene TR-542 Final by inhalation; Natur. C–S–C–C Feb 2009 Yes! Occur. foods/flavors Isoeugenol TR-551 E–N–C–E Final Maybe FEMA GRAS essen. oil Sept 2010 Clove, nutmeg, basil, bay leaf, cinnamon β-Myrcene TR-557 Final C–E–C–E Dec 2010 Yes! FEMA GRAS essen. oil “Levels of Evidence” M Rat – F Rat – M Mouse – F Mouse C = Clear S = Some E = Equivocal N = No© 2011 Coughlin &Associates
  66. 66. 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?© 2011 Coughlin &Associates
  67. 67. Food Warnings – Regulatory Update Project  Section 25601 – discussion of a Safe Harbor program for warnings for exposures to listed chemicals in food products sold at retail  Several Stakeholder Workgroup meetings and pre-regulatory public workshops have been held since 2008  Latest public draft of pre-regulatory proposed language was released in May 2010; much discussion and disagreement since!  Potential warning methods: pamphlets, cash register receipts, on- product warnings, shelf signs, in-store kiosks, website  April 28, 2011: OEHHA announced plans to work on unfinished Regulatory Update Project; not sure where Food Warnings fit in now.© 2011 Coughlin &Associates
  68. 68. PROP 65… PRODUCT COMPLIANCE© 2011 Coughlin &Associates
  69. 69. Strategies For On-Going Prop 65 Compliance Monitoring  Programmed monitoring of key ingredients for listed chemicals  Supplier certification of ingredients  Focused sampling of your ingredients and products© 2011 Coughlin &Associates
  70. 70. Prop 65 Compliance Strategy Step 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.© 2011 Coughlin &Associates
  71. 71. Characterize Your Products  Identify major ingredients  Develop matrix of ingredients common to multiple products  Identify major processing steps which may affect the concentration of selected chemicals (e.g., drying)  Identify the source(s) of ingredients by season / region / plant  Identify the stages of the process where mixing of different ingredients or different sources of ingredients will occur  Characterize the distribution of potential residues.© 2011 Coughlin &Associates
  72. 72. Steps for Product-Specific Dietary Exposure Assessment  Monitor Prop 65 activities very closely  Identify listed chemicals to be assessed  Work within your industry sector to prevent chemical listings  Identify products to be assessed  Develop your legal and the risk assessment strategies  Conduct necessary exposure assessments  Determine the process for evaluating compliance © 2011 Coughlin & Keep records for "due diligence"Associates
  73. 73. 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  Will the food industry “survive” Prop 65?? Only time will tell!!© 2011 Coughlin &Associates
  74. 74. 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!© 2011 Coughlin &Associates

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