Proposition 65: Scientific and Regulatory Challenges Facing the Food Industry

James R. Coughlin, Ph.D.

Coughlin & AssociatesLaguna Niguel, California

jrcoughlin@cox.netwww.jrcoughlin-associates.com

Symposium: California Proposition 65: Foods are Under Siege!

IFT Annual MeetingAnaheim, California

June 7, 2009

Major Problems for Us Today:Food issues were “under the radar” for many years

But actions on foods have been out of control for the past several years…targeting deep pockets!

Focus is on Individual Food Chemicals…

… but unfortunately, this law has nothing to do

with the Safety or Benefits of the Whole Product

or the advancement of public health.

No Significant Risk Level (1 x 10-5)

507 Carcinogens

No Observable Effect Level ÷ 1000

282 Reproductive Toxicants [DARTs]

Exposure (µg/day), Not Concentration!

Mechanisms for Listing Chemicals

“State’s Qualified Experts” -- 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 (IARC, NTP, FDA, EPA, NIOSH).

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.

“State’s Qualified Experts”

Carcinogen Identification Committee (the “CIC”)7 California experts (4 M.D. / 3 Ph.D.)

Developmental and Reproductive Toxicants Identification Committee (the “DART” Committee)

8 California experts (3 M.D. / 5 Ph.D., 1 from industry)

CIC and DART Committees meet separately once or twice a year in open public meetings

Prioritize chemicals for their future listing considerationRecommend listing of chemicals (each member a Yes/No vote)Provide scientific guidance to OEHHAPublic gets the opportunity to testify

Carcinogen "No Significant Risk Levels" (NSRLs)

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:Dose-response assessment is conducted to determine the "no significant risk level" associated with a cancer risk of 10-5

“1000-Fold” Safety/Uncertainty Factor for DARTs

Used to calculate the “Maximum Allowable Daily Level” (MADL), which is 1,000-times lower than the NOAEL

Its use has never been scientifically defensible for animal no-effect levels; and it can also be applied to a humanepidemiology no-effect level if that is the toxic endpoint

Reduced Uncertainty Factors (UFs) are being used elsewhere, when there is good data quality and when toxicokinetics and toxicodynamics of the chemical are known

Problem: an advancing science is locked into law; these scientific advances demand a reappraisal!!

“Safe Harbor” Levels (NSRLs, MADLs)

Notice (Feb 1, 2008): “New Practice Regarding the Development of Proposition 65 Safe Harbor Levels for Newly Listed Chemicals”

After a chemical is added to the list, OEHHA tries to develop and release for public comment a draft safe harbor level within one year of the chemical’s listing

OEHHA must adopt a final safe harbor level into regulation within one year or restart the regulatory process.

http://www.oehha.ca.gov/prop65/pdf/2008MayStatusReport.pdf

Practical Implications of “Safe Harbor” Levels

They are often extremely low (μg/day range) and have become “a line in the sand”! [Lead is at 0.5 µg/day]

No safe harbor level is established for 2/3 of the chemicals

Warnings are required if “safe harbors” are exceeded

Businesses can develop alternative NSRLs or MADLs, if such levels can be shown to be scientifically valid, but they do so at their own peril!

In reality (at settlement negotiations), the mere detection of a chemical will subject you to the need to warn.

Food-related ChemicalsHeavy Metals - arsenic, lead, cadmium, mercury, chromium

Organic Solvents - chloroform, methylene chloride

Naturally Occurring - formaldehyde, acetaldehyde, caffeic acid, urethane

Pesticides - EBDCs, DDTs, fumigants, herbicides, ethylene oxide

Mycotoxins - aflatoxins, ochratoxin A, fumonisin B1, fusarin C

Additives - BHA, flavorings, phthalates, vinyl chloride, nitrous oxide

Nitrosamines – DMN, DEN, nitrosopyrrolidine

Heat-induced – PAHs, heterocyclic amines, acrylamide, furan

Nutrients – Retinol / retinyl esters (> 10,000 I.U.)

Environmental Contaminants – dioxins, PAHs, PCBs, PCDFs, DBPs (water)

Food Regulations under Prop 65:Key Exemptions and Challenges

“Cooking” exemption

“Averaging” intakes of listed chemicals

Determining daily consumption rates

“Naturally Occurring” exemption

Revised food warnings are coming!

“Cooking” and Related ExemptionsSection 25703 contains the “Cooking Exemption” for certain kinds of food chemicals (carcinogens only, not DARTs)

Where chemicals in food are produced by cooking necessary to render the food palatable or to avoid microbiological contaminationIn these cases, there can be an allowance for an increased NSRL, i.e., an “alternative risk level” where it can be supported by “sound considerations of public health” (but this has proven very difficult to achieve)

Where chlorine disinfection is necessary to comply with sanitation requirements, even though a listed chemical may be formed (Disinfection byproducts)

Where a clean-up and resulting discharge is ordered & supervised by an appropriate governmental agency or court.

Question of “Averaging” ExposuresFor carcinogens, 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, since no“averaging” is permitted

For environmental / occupational exposures at or near food plants, what do we do with one-time 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 in products, but on the amount consumed per day (micrograms per day)

Must determine intakes by actual eaters, not per capita:Nationwide food product consumption databases (CSFII, NHANES), which have limited California data Individual company (or specific industry) marketing data

e.g., Apple juice (with 0.8 ppb Pb); MADL = 0.5 μg Pb/dayIf the average consumer drinks 0.5 liters/day => exposure = 0.4 μg Pb/dayBut if average consumption is 0.7 liters/day:

Exposure = 0.56 μg Pb/dayOver the MADL, and a warning would be required!

"Naturally Occurring" Exemption

Section 25501: regulation was adopted in 1989 exempting "naturally occurring" carcinogens and DARTs in foods (soil minerals, fungal toxins, natural pesticides)

Regulation: allows subtracting out natural background level from the total level in a food, but only that portion that is not added from “human activity” (but cooking / heating is human activity)

Nicolle-Wagner v. Deukmejian et al. (LA County Superior Court, August 1989) challenged Section 25501 exemption; regulation was upheld, and Court of Appeals upheld this exemption

Problems: how to distinguish “natural” from “man-made” exposures (lead in soil)? “Lowest level currently feasible” is demanded. Hugely expensive to demonstrate.

Lead in Chocolate CaseAmerican Environmental Safety Institute v. Mars et al., over the failure to warn about trace levels of 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 grownNo Pb-based chemicals are used on cocoa plantsCocoa is farmed far from sources of Pb pollutionPb levels in the beans are reduced successively in processingPb in the product is isotopically consistent with geologic Pb

Case was dismissed in Dec 2003 when the plaintiff’s attorney accepted a nuisance value settlement just before trial. Huge victory for the industry!

Mercury in Fish Cases – Fresh FishRetail grocery stores:

AG sued in Jan 2003 for failure to warn shoppers in fresh fish departments and markets (swordfish, mackerel, etc.)Birth defects warning signs are now posted as part of the settlement (the grocery chains caved in)First ever food warning under Prop 65!

Restaurants:Ag sued in 2003 for failure to warn customers about risks of eating swordfish, shark, mackerel, tilefish and tunaFeb 2005 settlement:

Signs must be posted warning pregnant women and children not to eat certain fish and to limit tuna consumption$ 264,000 for civil penalties and consumer education$ 118,000 to reimburse AG’s costs.

Mercury in Fish Cases – Canned Tuna

People v. Tri-Union Seafoods et al. (June 2004); AG sued the three largest tuna canning companies alleging failure to warnconsumers about mercury risks

Tuna companies filed motion to dismiss the suit, based on federal preemption arguments

2006, SF Superior Court judge ruled in favor of the industry:Prop 65 warnings would conflict with federal lawMercury exposures were < 0.3 µg/day (below companies’ MADL)Most methylmercury was determined to be “naturally occurring”

AG appealed, but industry viewpoint was upheld; no labels on canned tuna.

Meat Industry Sues for Federal PreemptionIn 1987, USDA Secy Richard Lyng wrote to the Governor expressing USDA’s view that the Federal MIA of 1906 preempted Prop 65.

In Nov. 2004, “60-Day Notices” were filed by Dr. Whitney Leeman against grocery retailers and meat companies, for not warning about dioxins (carcinogens) and PCBs (carcinogens & DARTs) in ground beef and beef liver

American Meat Institute and National Meat Assn. sued Leeman (a first!) in San Diego Superior Court (May 2005) before she could sue

Industry won MSJ Feb. 2008, that Prop 65 is preempted because it would mislead consumers into believing that meat had not passed federal inspection and was otherwise unfit for human consumption

Case is currently at the Court of Appeals.

Sodium Nitrite Beats Listing - A Big Victory!April - December 1998 – OEHHA requested information on sodium nitrite for potential listing as a DART under the Authoritative Bodies listing mechanism; OEHHA published “Notice of Intent to List Sodium Nitrite as a Developmental Toxicant”

February - May 1999 – AMI-led industry coalition submitted comments objecting to nitrite’s listing; 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 Committee

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 NOTto list sodium nitrite as a DART!

Acrylamide Facts under Prop 65Listed as carcinogen based on U.S. EPA and IARC as Authoritative Bodies way before it was discovered in foods in 2002

Acrylamide’s NSRL = 0.2 μg/day, based on the average daily intake found to cause an excess cancer risk of 1 in 100,000 (linear risk assessment)

Industry fought hard for 3 years for a higher NSRL but lost; our arguments on “naturally occurring” and “cooking” exemptions were also rejected

Big Problem: for most food products with any detectable level, even a daily 1-ounce serving exceeds the NSRL and requires a cancer warning; BUT…it’s in 100’s of food products making up ~ 40% of our calories!!

Battleground: several fast-food restaurants (French fries) & potato chip manufacturers were sued in 2002 by “bounty hunter” attorneys, because nowarnings were being given.

“Food Warnings” Regulatory Concept

OEHHA notice (Feb 15, 2008): “Regulatory Update Project, Warnings For Exposures To Listed Chemicals In Foods”

OEHHA wants to develop possible regulatory language addressing the methods of delivery and content of warnings

Ideas about on-product labels, off-product signage, centralized warnings for all affected food products in the store, in-store warning information kiosks or binders, print media warnings or web-based informationVoluntary participationOEHHA as a clearinghouse function

Stakeholder working group has developed a draft regulation for OEHHA’s consideration; OEHHA draft to be released end of August; September 25 workshop is scheduled.

“Beneficial Nutrients” Regulatory Concept

OEHHA notice (March 2008) to float a proposed regulation on “Exposure to Beneficial Nutrients in a Food”

Goal: to develop less strict risk levels in anticipation of some nutrients being listedManganese and boron cannot meet 1,000-fold safety level Industry comments were submitted at two workshops in 2008

OEHHA proposed some really ridiculous actions!Setting Food and Nutrition Board RDAs for a listed nutrient as the “no exposure” level, and then requiring warnings if levels are above the RDA level; fortunately we defeated this

This Regulatory Concept makes absolutely no scientific sense and would actually be detrimental to public health; put on hold for now.

“Labor Code” Listing Regulatory Concept

OEHHA proposed “Possible Regulatory Language” in May 2008; industry submitted strong comments against use of LC

Automatically lists chemicals if they are already on IARC, NTP or ACGIH lists; no science is allowed to be debated, thus trumping the other 3 listing mechanisms!

14 chemicals listed by LC to date, including nitrous oxide (food aerosol propellant), but still no regulation is in place; OEHHA will just let court decide

Long list of chemicals could be automatically added soon, including food chemicals such as sodium nitrite, titanium dioxide and others.

Listings under Consideration by DART Committee

OEHHA’s September 7, 2007 prioritization notice asked DART Committee to recommend whether 8 chemicals should be further evaluated, including bisphenol-A and caffeine

DART Committee decided on December 10, 2007 to ask for Draft Hazard Identification Documents (HIDs) for all 8 chemicals;hexavalent chromium added Nov 2008, chlorpyrifos not listed

Bisphenol-A data call-in 2008; draft HID released in May 2009; scheduled for DART Committee listing decision July 15, 2009

Caffeine data call-in completed in 2008: Soft drink, coffee and supplements industries submitted commentsOEHHA stated that caffeine in coffee / tea / chocolate products was “naturally occurring,” and thus not subject to warnings if caffeine is eventually listed.

Listings under Consideration by Carcinogen Identification Committee

OEHHA’s March 2009 prioritization notice asked CIC to recommend whether 38 chemicals should be further evaluated for listing

CIC recommended to OEHHA on May 29, 2009 to prepare draft Hazard Identification Documents (HIDs) for:

9 “High Priority” chemicals, including fluoride, 1,3-dichloro-2-propanol, 3-MCPD 13 “Medium Priority” chemicals, including aspartame

CIC will be reviewing a second batch of chemicals for prioritization at their next meeting in November 2009, and some will surely be food chemicals.

Conclusions Many Prop 65-listed chemicals ARE in the foods and beverages that you manufacture

We thought 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 industry suffered its first warning losses on fresh fish and restaurant French fries; we are now fighting to prevent acrylamide warnings on potato chips, listing of beneficial nutrients with warnings, and listing of caffeine (DART) in soft drinks and nitrite (carcinogen) in cured meats

I believe that NO cancer or birth defects warnings are scientifically justified on any foods in California or elsewhere, because the wholefood, not individual chemicals, is what should be assessed.

Prognosis for Foods??The stakes are very high!

Bounty Hunters have been thriving as an industry Our products are under increasing pressureFinancial health of companies is being challenged Credibility of federal government regulatory agencies is suspect

Industry chemists, toxicologists, lawyers, regulatory affairs specialists, product developers, even nutritionists (if nutrients are going to be listed) must increase their FOCUS on Prop 65

Keep chemicals from being listed in the first place!

Will the food industry “survive” Prop 65’s assault ?

Only time will tell…Stay tuned!!!