Proposition 65: Scientific and Regulatory
Challenges Facing the Food Industry
James R. Coughlin, Ph.D.
Coughlin & Associates
Laguna Niguel, California
Symposium: California Proposition 65:
Foods are Under Siege!
IFT Annual Meeting
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)
282 Reproductive Toxicants [DARTs]
No Observable Effect Level ÷ 1000
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 consideration
Recommend listing of chemicals (each member a Yes/No vote)
Provide scientific guidance to OEHHA
Public gets the opportunity to testify
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..."
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 human
epidemiology 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.
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 Regulations under Prop 65:
Key Exemptions and Challenges
“Averaging” intakes of listed chemicals
Determining daily consumption rates
“Naturally Occurring” exemption
Revised food warnings are coming!
“Cooking” and Related Exemptions
Section 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 contamination
In 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
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” Exposures
For 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
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
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
But if average consumption is 0.7 liters/day:
Exposure = 0.56 μg Pb/day
Over 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 Case
American Environmental Safety Institute v. Mars et al., over
the failure to warn about trace levels of lead (Pb) in
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 when the plaintiff’s
attorney accepted a nuisance value settlement just before
trial. Huge victory for the industry!
Mercury in Fish Cases – Fresh Fish
Retail 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!
Ag sued in 2003 for failure to warn customers about risks of
eating swordfish, shark, mackerel, tilefish and tuna
Feb 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 warn
consumers 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 law
Mercury 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
Meat Industry Sues for Federal Preemption
In 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 NOT
to list sodium nitrite as a DART!
Acrylamide Facts under Prop 65
Listed 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 no
warnings 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
OEHHA 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 listed
Manganese 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 comments
OEHHA stated that caffeine in coffee / tea / chocolate products was
“naturally occurring,” and thus not subject to warnings if caffeine is
Listings under Consideration by Carcinogen
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-
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.
Many Prop 65-listed chemicals ARE in the foods and beverages that
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 whole
food, 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 pressure
Financial 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!!!