Coughlin_NorCal IFT_Proposition 65_May 2011

California Proposition 65: Scientific, Regulatory and Legal Issues Impacting the Food Industry

James R. Coughlin, Ph.D.President, Coughlin & Associates

Aliso Viejo, [email protected]

www.linkedin.com/in/jamescoughlin

Northern California IFTPleasanton, CA

May 3, 2011

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


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

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 understandcomplex technical/economic issues of chemical regulation

Community “right-to-know” laws were evolving elsewhere (e.g., New Jersey).


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


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!


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 –

http://oehha.ca.gov/prop65.html© 2011 Coughlin & Associates

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.


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


Major Provisions of Proposition 65

Hazard Identification of Chemicals

Warnings and Discharge Prohibitions

Enforcement Actions


What Kind of Exposures?

“Knowingly and intentionally expose”

Exposures can occur by: Consumer product exposure Environmental exposure Occupational exposure


“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


“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

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

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.


No Significant Risk Level [NSRL] = (1 x 10-5)

Over 500 Carcinogens

MADL = No Observable Effect Level1000

Over 300 Reproductive Toxicants [DARTs]

Exposure (µg/day), Not Concentration!© 2011 Coughlin & Associates

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.


“The Dose Makes the Poison”

“All things are poison and there is none

which is not a poison. Solely the dose

differentiates a poison from a remedy.”Paracelsus(1493-1541)




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.


60-Day NoticesLead (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 bulbs, holiday string lights

Carbon monoxide in parking garages

Stain glass lamps and other artistic/decorative items

PVC-coated cables, locks, exercise weights, rainwear

Wristwatch bands, jewelry Solvents in spray paints/strippers

Foods/supplements DEHP in vinyl placemats© 2011 Coughlin & Associates

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

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

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.


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)


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 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.”


Food & Supplement-related ChemicalsHeavy 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

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.


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

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


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.


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!


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.”


Food Regulations Under Prop 65:

Key Exemptions and Challenges


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.


“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 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).


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.


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

"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.


"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.


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.


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.


Food Acrylamide Range (ppb)Baby food/biscuits ND - 442

Breads/bakery products ND - 364

Cereals 11 - 1057

Chocolate products ND - 909

Coffee (roasted, not brewed) 37 - 374

Coffee (brewed) 5 - 11

Cookies/crackers 26 - 1540

Dairy drinks ND - 43

Dried foods/mixes ND - 1184© 2011 Coughlin & Associates

Food Acrylamide Range (ppb)French fries 117 - 1325

Fruits/vegetables (canned) ND - 83

Gravies/seasonings ND - 151

Infant formulas ND

Nuts/nut butters ND - 457

Potato chips 117 - 4080

Snacks (other salty) 12 - 1340

Olives 123 - 1925

Prune juice 53 - 326© 2011 Coughlin & Associates

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

--- despite coffee reducing the risk of several human cancers! © 2011 Coughlin & Associates

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).


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.


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.


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

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)

Settlement has been negotiated between the parties. © 2011 Coughlin & Associates

Lead (Pb) in Apple & Grape Juices, Packaged Peaches & 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.


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

“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.


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?


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


NTP -- Supplement Ingredients

Substance Levels of Evidence

Technical Report (TR)

Likely to be Listed?

Chromium Picolinate TR-556

E – N – N – N

Final June 2010

NO

Ginseng TR-567

N – N – N – N

Draft Nov 19, 2009 Peer Review

NO

Goldenseal Root Powder TR-562

C – C – S – N

Final

August 2010

YES!!

Pulegone TR-563

N – C – C – C


YES!!

Milk Thistle Extract TR-565

N – N – N – N


NO

“Levels of Evidence” M Rat – F Rat – M Mouse – F Mouse C = Clear S = Some E = Equivocal N = No

NTP -- Supplement Ingredients




α β-Thujone Mixture TR-570, Herbal med, flavorings

S – N – N – N

Yes Peer Review Jan 26, 2011

No

Kava Kava Extract TR-571

E – N – C – S

Yes Peer Review Jan 26, 2011

Yes!

Aloe Vera Whole Leaf Extract TR-577, Herbal remedy

C – C – N – N

Yes Peer Review Apr 5, 2011

Yes!



NTP -- Food Ingredients




Cumene TR-542 by inhalation; Natur. Occur. foods/flavors

C – S – C – C

Final

Feb 2009

Yes!

Isoeugenol TR-551 FEMA GRAS essen. oil Clove, nutmeg, basil, bay leaf, cinnamon

E – N – C – E

Final Sept 2010

Maybe

β-Myrcene TR-557 FEMA GRAS essen. oil

C – E – C – E

Final

Dec 2010

Yes!



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?


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.


PROP 65…

PRODUCT COMPLIANCE


Strategies For On-Going Prop 65Compliance Monitoring

Programmed monitoring of key ingredients for listed chemicals

Supplier certification of ingredients

Focused sampling of your ingredients and products


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.


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

Steps for Product-SpecificDietary 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

Keep records for "due diligence"© 2011 Coughlin & Associates

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

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!


Health & Medicine

Coughlin_NorCal IFT_Proposition 65_May 2011