Processed-Formed Chemicals and Proposition 65

1. Scientific Considerations
James R. Coughlin, Ph.D. CFS
President, Coughlin & Associates:
Food/Nutritional/Chemical Toxicology & Safety
Aliso Viejo, California USA
jrcoughlin@cox.net
www.linkedin.com/in/jamescoughlin
GMA Science Forum
Processed-Formed Chemicals
and Proposition 65
March 27, 2019

2. Presentation Outline
 Wide range of “Processed-formed Chemicals” [PFCs] are already
listed [“Neo-formed” in Europe]
 Heat-related – Maillard Browning Reaction, caramelization,
dehydration concentration
 Not Heat-related – naturally occurring toxicants, heavy metals,
pesticides, indirect additives, disinfection byproducts, solvents
 Maillard Browning Reaction focus [acrylamide, 4-MEI, furan, furfuryl
alcohol…and beyond!]
 Scientific controversy over Coffee & Acrylamide warning exemption
 Forecasting: There is no end in sight…IARC & NTP will continue to
feed the Prop 65 “pipeline.”
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3. Food Contamination in the Food Processing Chain
~ Processed-Formed Chemicals [PFCs] ~
1. External raw food contamination due to agricultural and environmental
contamination
2. Transport of raw materials to the processing factory
3. Food conditioning, i.e., storage of raw materials, preheating, disinfection,
cleaning & sterilization steps
4. Heating of raw ingredients [boiling, cooking, baking, roasting, frying,
pasteurization, sterilization, irradiation] or combining them with other
ingredients at high temperature in an oven or other equipment
5. Post-processing contamination -
 Food packaging
 Transport of packaged food
 Storage and distribution of packaged food.
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4. Prop 65 Food Chemicals Listed
Heavy Metals - arsenic, lead, cadmium, mercury, nickel
Organic Solvents - chloroform, methylene chloride, hexane
Aldehydes - formaldehyde, acetaldehyde, malonaldehyde, dicarbonyls
Pesticides - DDTs, fumigants, herbicides, ethylene oxide, glyphosate
Mycotoxins - aflatoxins, ochratoxin A, fumonisin B1, fusarin C
Antioxidants - BHA/BHT, caffeic acid
Packaging Additives – styrene, phthalates, vinyl & vinylidene chloride, BPA
Nitrosamines – DMN, DEN, N-nitroso-pyrrolidine
Heat-induced Carcinogens - PAHs, HCAs, acrylamide, furan, 4-MEI, furfuryl
alcohol, chloropropanols [3-MCPD & 1,3-DCP]
Disinfection Byproducts – chlorinated & brominated
Environmental Contaminants - PAHs, asbestos, dioxins, PCBs, PCDFs
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5. Concentration Range of Food Contaminants
< 500,000
ppb
< 1,000 ppb
< 100 ppb
< 1ppb
• Furfuryl Alcohol
• Furan
• Acrylamide - 2002
• Mycotoxins, PAHs
• Nitrosamines, HCAs
• Pb, As, Cd, Hg
• Dioxins
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6. Ammonia
Alkyl amines
Amino acids
Proteins
Phospholipids
Aldehydes
Ketones
Sugars
Carbohydrates
Lipids
Carbonyls
Esters
Amides (Acrylamide)
Heterocyclic Compounds
Amine
Carbonyl
Amino-Carbonyl
Interaction
(Amadori Products)
HEAT
HEAT
Furans Oxazoles
Pyrroles Imidazoles
Thiophenes Pyridines
Thiazoles Pyrazines
Melanoidins
(pigments)
Volatile Compounds
(aroma chemicals)
General Scheme of Maillard Browning Reaction

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8. “Maillard Browning Reaction”
Listed Carcinogens
~
Acrylamide
4-Methylimidazole
Furfuryl Alcohol
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9. Acrylamide
Listed as a Carcinogen
~
A Huge Battleground Since 2002
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11. 4-Methylimidazole
Listed as a Carcinogen
~
Cola / Caramel Formulations Modified at Great Cost
to Get Lower Concentrations
Also in Coffee and Other Heated
Food/Beverage Products
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12. Furfuryl Alcohol
Listed as a Carcinogen in Sept. 2016
Based on U.S. EPA (AB)
~
Classified by IARC (Vol. 119, 2019)
~
60-Day Notices Began Appearing in Fall 2017
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14. The Working Group actually came to a Group 4 conclusion,
“probably not carcinogenic to humans,” but the Monographs
Director forced them into a compromise to Group 3, claiming that
the downgrade from Group 2B (in 1991) to Group 4 was
impossible for IARC.
 They
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15. My Conclusions on IARC’s Coffee Evaluation [2016]
 The IARC Working Group was not able to associate even one human organ to an increased
risk of cancer due to coffee consumption, but concluded that coffee is Group 3, “not
classifiable as to its carcinogenicity to humans” [which essentially means “we couldn’t
decide”]. Monograph No. 116 was published in June 2018.
 Their correct evaluation on breast, prostate and pancreas cancer should have been
sufficient evidence to give coffee a Group 4, “probably not carcinogenic to humans.” [only
1 substance out of over 900 has ever gotten this rating].
 For liver and uterine endometrium cancers, where they correctly concluded “reduced risk”
of cancer, IARC would actually need to establish a new category of Group 5, “probably
reduces the carcinogenicity to humans.”
 In sum, IARC’s final classification as Group 3 is totally unsupported by the vast scientific
evidence on coffee and cancer…they got this wrong!
 But IARC [2016] was actually a “victory” of sorts for the global coffee industry, since coffee
did spend 25 years as Group 2B “possibly carcinogenic to humans” due to an unsupported
link to human bladder cancer.
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16. The “Coffee / Cancer Paradox”
 All global health and regulatory authorities, including IARC & Prop 65, now agree that
coffee drinking is NOT causing any increased risk of human cancer
 In fact, hundreds of human studies show significant risk reductions for numerous
cancers, in spite of the presence of many animal carcinogens [like acrylamide] at low
“parts per billion” concentrations in brewed coffee
 How can this be? What is protective?
 Naturally occurring antioxidants (chlorogenic acids)
 Heat-formed antioxidants (coffee’s brown color = melanoidin polymers)
– Properties: chemo-preventive, antioxidant, antimicrobial, soluble dietary fiber,
chelate toxic metals
 Some chemicals in coffee induce detoxification enzymes (e.g., GST for acrylamide)
 I have termed this the “Coffee-Cancer Paradox” – resulting from doing a “Benefit-Risk”
evaluation using the “Holistic Approach”
So, the Paradox – Coffee contains many animal carcinogens at
trace levels, but it actually reduces some organ cancer risks in
people without causing cancers in any other organs.
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18. My Major Concern with the latest proposal…
 We are only one IARC Classification of a chemical or one NTP Cancer
Bioassay chemical report away from the warning exemption for coffee
being worthless.
 IARC’s current “High Priorities” [2015-2019] include a re-do of acrylamide
& furan, but also an evaluation of 5-HMF, which they could torture
mechanistically to a “sufficient evidence” finding and eventual Prop 65
listing
 Furfural could also come back from a failed Authoritative Body [EPA]
proposed listing in 2015 if based on the NTP [1990] bioassay or if
classified by IARC.
 IARC’s “Advisory Group to Recommend Priorities” for the IARC
Monographs for 2020–2024 is meeting this week in Lyon...it should be
quite the list!
 The methylfurans in coffee could be included [next slides]
 The coffee warning exemption is at major risk if one or more new
coffee chemicals get listed after March 15, 2019.
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22. My Conclusions…
 More Processed-formed Chemicals [PFCs] will continually be added to
the Prop 65 List.
 There is no end in sight in Year 33…
 IARC & NTP will continue to feed the Prop 65 pipeline
 The “State’s Qualified Experts” [the CIC and DARTIC committees]
will also be asked to determine additional listings
 OEHHA will continue to use the Labor Code mechanism to do
“slam-dunk” listings.
 Finalization of the proposed coffee warning exemption…
 Puts coffee at a major risk if one or more new coffee chemicals get
listed after March 15, 2019
 The proposed regulatory language makes no scientific sense
because OEHHA has correctly concluded that coffee poses no
human cancer risk. A newly listed chemical(s) [that has always
been there] cannot raise the risk.
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23. Thank You!
~
Questions?
James R. Coughlin, PhD CFS
jrcoughlin@cox.net
949-916-6217

24. Selected Reference Materials
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