Contaminants and Residues in Dietary Ingredients

1. Contaminants and Residues in
Dietary Ingredients
James R. Coughlin, M.S. Ph.D. CFS
President, Coughlin & Associates
Aliso Viejo, California
jrcoughlin@cox.net
www.linkedin.com/in/jamescoughlin
~ Council for Responsible Nutrition ~
Toxicology Workshop
Assessing the Safety of Ingredients in a
Formulation
May 19, 2022

2. Presentation Outline
 Introduction to Dietary Contaminants
 Codex Committee on Contaminants in Food (CCCF15) - May 2022
 Metals, mycotoxins, future priorities
 U.S. Food and Drug Administration - Recent Activities on Toxic
Metals
 California Proposition 65…Your Favorite Law!!!
 Future Considerations
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3. Contaminants in Dietary Ingredients
My Contaminants “Journey”…
 UC Davis 1st Tox class 1973
 UCD research on carcinogens
in heat-processed foods
 California Prop 65, 1987-
 Codex Committee on
Contaminants in Food (CCCF) -
Head of IFT’s Codex Delegation,
2005-2021; NCA this year
 Foods → FF’s → DS’s
 GRAS evaluations
 Assisting clients for 30 years on
contaminants
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5. Historical Concentration Range of
Food Contaminants
< 500,000
ppb
< 1,000 ppb
< 100 ppb
< 1ppb
• Furfuryl Alcohol
• Acrylamide - 2002
• Mycotoxins, PAHs
• Nitrosamines, HCAs
• Pb, As, Cd, Hg
• Dioxins
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6. Codex Committee on Contaminants in
Food (CCCF15)
Virtual Session
May 9-13 and May 24, 2022
Chaired by The Netherlands
3:30 am Pacific wakeup all last week!!
( (for the National Confectioners Assn)
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12. Maximum Levels for Total Aflatoxins and Ochratoxin A in Nutmeg,
Dried Chili & Paprika, Ginger, Pepper & Tumeric (delayed until 2023)
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14. U.S. Food and Drug Administration
~ Recent Activities on Heavy Metals ~
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20. “Baby Food Safety Act of 2021”
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23. FDA “Closer to Zero” Goals
Further reductions in the levels of arsenic, lead, cadmium,
and mercury in foods will be made by:
 Advancing the FDA’s research on and evaluating changes in
dietary exposures to these elements
 Setting action levels, with input from stakeholders
 Encouraging adoption of best practices by industry to lower
levels of toxic elements in agricultural commodities and
products
 Increasing targeted compliance and enforcement activities,
and monitoring progress of levels over time.
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26. FDA Proposed Action Levels for Lead in Juices
(first promise under Closer to Zero Action Plan)
 FDA Guidance in 2004 established an Action Level of 50 ppb
lead for juices
 The FDA now estimates that establishing a 10 ppb Action Level
for lead in apple juice could result in as much as a 46%
reduction in exposure to lead from apple juice in children.
 For all other fruit and vegetable juices, establishing an Action
Level of 20 ppb is estimated to result in a 19% reduction in
exposure to lead from these juices in children.
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35. California“Proposition 65”
“Safe Drinking Water and Toxic Enforcement
Act of 1986”
- “Right-to-Know” Warnings
- Prohibition of Discharge
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37. What Does Proposition 65 Prohibit?
 Discharging listed chemicals (only carcinogens and
reproductive toxicants) into “sources of drinking water” in
California; and
 Exposing people in California to listed chemicals without
prior warning (“failure to warn”)
 Prop 65 does NOT ban chemicals in products
 Applies to consumer products, as well as to occupational
and environmental exposures.
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41. Consumer Product “Safe Harbor” Warnings (Historical)
Carcinogens: “WARNING: This product contains a chemical known
to the State of California to cause cancer.”
Reproductive toxins: “WARNING: This product contains a chemical
known to the State of California to cause birth defects or other
reproductive harm.”
If Both: “WARNING: This product contains a chemical known to the
State of California to cause cancer and birth defects or other
reproductive harm.”
Note: The warnings (since August 2018) must now specify at least
one chemical or agent.
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42. Exceptions to Warning Requirement
 Exposure at levels that present “no significant risk” of cancer (if
level is below “No Significant Risk Level” or “NSRL”)
 Exposure at levels less than 1/1000 of the “No Observable Effect
Level” for Developmental and Reproductive Toxicants (if level is
below “Maximum Allowable Dose Level” or “MADL”)
 Waiting period after official listing of the chemical: 12 months for
exposures
 If Federal law governs a warning in a manner that preempts state
authority.
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43. Major Problems for Foods/Supplements/Consumer Products
 These products have been UNDER SIEGE by the California Attorney General’s
office, bounty hunter attorneys and Cal EPA’s Office of Environmental Health
Hazard Assessment (OEHHA) for decades, even though we didn’t expect this 35
years ago
 Many key contaminant chemicals, but also specific foods (red & processed meats)
and herbal actives (Aloe vera, goldenseal root powder), have been listed by four
different listing mechanisms, and more listings are always coming
 Prop 65 focus is on the mere presence of individual chemicals, since bounty
hunters typically run a few tests and then file 60-day notices against companies
 Not focussed on the safety or benefits of the WHOLE product…nor about any real
HARM to consumers! Discussion of health benefits not permitted!
 Over 900 chemicals listed, about 1/3 have “Safe Harbor Levels” adopted by the
state.
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44. No Significant Risk Level [NSRL] = (1 x 10-5)
Over 550 Carcinogens
MADL = No Observable Effect Level
1000
Over 350 Reproductive Toxicants [DARTs]
Exposure (µg/day), Not Concentration!
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45. Food & Supplement-related Chemicals
Heavy Metals - arsenic, lead, cadmium, mercury
Organic Solvents - chloroform, methylene chloride, benzene
Aldehydes - formaldehyde, acetaldehyde, malonaldehyde
Pesticides - EBDCs, DDTs, fumigants, herbicides, ethylene oxide, glyphosate
Mycotoxins - aflatoxins, ochratoxin A, fumonisin B1
Packaging & related chemicals – phthalates, vinyl chloride, styrene, BPA, PFOA/PFOS
Nitrosamines - Dimethylnitrosamine, ~ 50 others
Heat-induced carcinogens - PAHs, HCAs, dioxins, acrylamide, furan, furfuryl alcohol
Nutrients - Retinol / retinyl esters (> 10,000 I.U.)
Environmental Contaminants - PAHs, asbestos, dioxins, PCBs, disinfection byproducts
Constituents (naturally occurring) – methyleugenol, pulegone, beta-myrcene
Herbal actives (not contaminants!) – aloe vera (non-decolorized whole leaf extract),
goldenseal root powder
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46. "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”; and only present at “lowest level currently feasible”
 “…is naturally occurring only to the extent that it was not avoidable by good
agricultural or good manufacturing practices.” [e.g., lead in calcium
supplements case]
 Problems: how to distinguish “natural” from “man-made” exposures (e.g.,
lead from soil vs. from processing contamination)?
 Mercury in canned tuna was the rare win at trial!
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47. Dietary Supplements and Lead
(up to 2010, an old slide)
 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, a new plaintiff, Environmental Research Center, has
issued 117 60-day notices regarding lead and other heavy
metals in dietary supplements.
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49. What is the real standard for lead?
 Different standards have been set for “naturally occurring” lead in dietary
supplements:
 Lead in calcium supplements = 1.5 µg/day (AG’s Settlement 1997-98)
 Since then, multiple settlements with different lead levels have been
set
 Now several standards exist for lead in dietary supplements - 0.5, 1.5,
2.75, 4.5 µg/day
 We can fight for a higher safe level for lead in foods, supplements and
consumer products -
 Try for naturally occurring exemption, but we must prove the “lowest
level currently feasible”
 Lead is much less bioavailable by the oral route vs. inhaled dust, but
reduced bioavailability has never mattered – we are stuck with what
crosses the lips!
 What about pressing for a food/supplement (oral) safe level higher
than the current safe harbor level, since the MADL was originally set
based on the OSHA inhalation standard).
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51. Ecological Alliance, LLC sues Kroger over lead in
foods (February 14, 2022)
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52. Arsenic in Rice – Naturally Occurring Levels
Established
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53. Prognosis for Foods / Supplements / Consumer Products???
 Stakes are very high!! Bounty hunter attorneys are thriving; 60-Day Notices are
increasing, putting our products under increasing pressure; financial health of
some companies is being challenged; more product warnings are appearing;
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; monitor IARC
and NTP (as Authoritative Bodies) very carefully and intervene with science in
their activities early
 Fight during comment periods for higher “safe harbor” levels to avoid product
warnings; where no “safe harbor” levels have been adopted, industry has the
responsibility to develop their own “safe harbor” levels
 Monitor the “Governor’s List” and assess your products for Prop 65 compliance.
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54. Thank You!
~
Questions?
James R. Coughlin, MS PhD CFS
jrcoughlin@cox.net
949-632-4453

55. Additional Resources
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57. HTTPS://IAFNS.ORG/OUR-WORK/RESEARCH-TOOLS-OPEN-
DATA/METAL-DIETARY-EXPOSURE-SCREENING-TOOL/
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