1. Critical thinking in food safety Thomas J. Montville

2. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 2 This lecture will help you …  gain confidence in “sorting out the numbers.”  sort and evaluate claims and counter claims.  help you be a defacto spokesperson (for something).

3. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 3 You will be (are) a defacto spokesperson – FS/Nutrition  Food companies are filling our food with cancer causing poisons.  Food is cheap because all large food companies are getting huge government subsidies.  Natural food is healthier and more nutritious than food made by Agribuisness.  etc., etc.

4. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 4 Food Falsehoods:  Have kernel of truth  Easy to understand  Provide simple solution to very complex problems  Marketable (or exploitable)  Are sometimes well intentioned

5. What’s the harm in misrepresent in facts?  False sense of security Bigger risks ignored – or incurred. In spite of environmental damage, we drink bottled water due to worries about municipal water (pesticides, cancer, heavy metals). Bigger problems than water; obesity.  Health Risk and Death Chlorinated hydrocarbons are cancer threat, Peru stops chlorination of water causing 11,000 cholera deaths; DDT could prevent 3-6 million deaths/year  Increased costs Unnecessary Testing (McDonalds) Organic food costs 67% more Environmental damage of packaging vs. additives Biotech foods – cheaper (at least on the surface)

6. Different groups see the facts through different lenses.  Media- where’s the story, the sound bit  Activists – where’s the cause, the influence  Lawyers – where’s the justice, the money  Regulators- where’s our protection, influence  Business – ability to stay in business, do the right thing, money  Individual Scientists – where’s the funding, support for their hypothesis, “the truth”

7. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 7 Scientists can wait until all the data are in. Activists can demand action based on emotion. Government regulators must act using “the best science available.”

8. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 8 Regulations result from  “the facts” derived from “the best science available”  economics  practicality  compromise FDA uses Food Advisory Committee

9. The problem with “facts”….  facts can be dull  fact can be very dull (Inconvenient Truth)  facts require interpretation  Try to get at the data underneath “the facts”. Beware of statistics *Beware of ratios: Because of the increased use of food additives, the % of childhood deaths caused by cancer has increased steadily over the last 100 years. *Beware of % and “fold.” The data: Incidence of cancer increased from 1 in 1,000,000 to 2 in 1,000,000. The buzz: 2-fold increase in cancer. Cancer up 100%.

10. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 10 Absolute number (cases/100,000 deaths) Infectious disease , infant mortality , industrial accidents , malnutrition  Absolute number (cases/100,000 deaths) Cancer  Therefore % due to cancer .

11. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 11 An important digression on “number literacy” One can’t explain what one doesn’t understand.

12. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 12 GGram = 1/28 th of an ounce  ug = 1/1,000,000 of a gram  g = 0.000000037 ounce gug/kg = ppb = 0.00000074 ounce/pound Regulatory Units = Scientific Units

13. Cheat Approximate Regulatory Units (It’s better to have an approximation that you understand than an exact number that is incomprehensible.) 30 grams ~ 1 ounce 500 g ~ 1 pound; 1,000 grams (1 kilo) ~ 2 pounds (These are “off” by 10%) 1 liter ~ 1 quart 1 meter ~ 1 yard ~ 3 feet. Altitude of San Madres is 3000 meters ~ 9,000 feet. 1 nautical mile ~ 1 statute (regular) mile

14. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 14 ppm is tiny – 1 inch in 16 miles ppb is tinier- 1 cent in ten million dollars “fecal coliform” is not “feces” Under Understanding the language.

15. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 15 False reasoning: Furfural causes cancer Bread contains furfural Eating Bread Causes Cancer

16. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 16 1 slice white bread contains 167 µg (micrograms) of furfural. Rodent carcinogenic dose of furfural = 197 mg (milligrams)/kg (kilogram) body wt/day = 197,000 µg/kg/day. (1 mg = 1,000 ug) Equivalent human dose, 70 kg (150 lb) person 82,600 slices of bread = 197,000 x 70 ÷ 167 = 82,600 slices of bread (dose) x (weight in kg) ÷ (amount per slice of bread) = slices of bread Does Does eating bread cause cancer?

17. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 17 T Two (political) case studies from the annals of the FDA’s Food Advisory Committee Note: An expert need not be a toxicologists, but must know how to think.

18. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 18 Patulin in Apple Juice Would limiting patulin in apple juice to 50 ppb protect public? U.S. apple industry in favor of this regulation. Several issues- does the public need to be protected? Will 50 ppm be enough? (Why not “zero?”) How much of the population should be protected.

19. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 19 Patulin in Apple Juice Would limiting patulin in apple juice to 50 ppb protect public? NoOservableEffectLevel (NOEL) = 0.3 mg/kg bw per week Add 100-fold safety factor Provisional Max Tolerated Daily Intake (PMTDI) = 0.43ug/kg bw per day

20. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 20 Patulin in Apple Juice Would limiting patulin in apple juice to 50 ppb protect public? NoOservableEffectLevel (NOEL) = 0.3 mg/kg bw per week Add 100-fold safety factor Provisional Max Tolerated Daily Intake (PMTDI) = 0.43ug/kg bw per day If a juice is 100% over the PMTDI, is it really dangerous?

21. Juice Samples from Current Production Age Group Ave. Juice Intake (g/person/d) Ave Patulin Exposure (µg/kg-bw/d) 90 th % Juice Intake (g/p/d) 90 th % Patulin Exposure (µg/kg bw/d) All ages 2000.094250 0.22 1 -2 years 2160.58434 1.3 <1 year 1280.50372 1.1 Ae Group Mean Apple Juice Intake (g/p/d) Mean Patulin Exposure (µg/kg bw/d) 90 th Percentile Apple Juice Intake (g/p/d) 90 th Percentile Apple Patulin Exposure (µg/kg bw/d) All ages 2000.0312500.078 1 -2 years 2160.174340.42 <1 year 1280.133720.38 Patulin Data Analysis Remember, PMTDIRemember, PMTDI = 0.43 ug/kg bw/d Is a regulation needed?

22. Patulin Data Analysis Without regulation All age groups 90% of population consumes < 0.22 ug/kg bw/day No need for regulation 1-2 year olds 90% of population consumes < 15 ounces juice consumes ~ 1.3 ug/kg per day Regulation needed

23. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 23 Food Advisory Committee Concerns Advisory Committee: Input data 15 ounces seemed “low” What is consumption beyond 90% of the population? Is it enough to protect 90% of the children? Mix of “regular” and “baby food” apple juice?

24. Exclude Data for Juice Samples with Patulin > 50 ug/kg d Age Group Ave. Juice Intake (g/person/d) Ave Patulin Exposure (µg/kg bw/d) 90 th % Juice Intake (g/p/d) 90 th % Patulin Exposure (µg/kg bw/d) All ages 2000.0940.0312500.220.078 1 -2 years 2160.580.17 (15 ounces) 434 (15 ounces) 1.3 0.42 <1 year 1280.50 0.13372 1.10.38 OK? Age Group Mean Apple Juice Intake (g/p/d) Mean Patulin Exposure (µg/kg bw/d) 90 th Percentile Apple Juice Intake (g/p/d) 90 th Percentile Apple Patulin Exposure (µg/kg bw/d) All ages 200250 1 -2 years 216434 <1 year 128372 Patulin Data Analysis

25. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 25 No Juice Samples Excluded Samples > 50 ug/kg Excluded REVISED AFTER FAC CONCERNS Age Group Ave. Juice Intake (g/person/d) Ave Patulin Exposure (µg/kg bw/d) 90 th % Juice Intake (g/p/d) 90 th % Patulin Exposure (µg/kg bw/d) All ages 2000.0940.031 0.042500.220.078 0.10 1 -2 years 2160.580.17 0.22434 1.3 0.42 0.67 <1 year 1280.50 0.13 0.133721.10.38 0.27 Age Group Mean Apple Juice Intake (g/p/d) Mean Patulin Exposure (µg/kg bw/d) 90 th Percentile Apple Juice Intake (g/p/d) 90 th Percentile Apple Patulin Exposure (µg/kg bw/d) All ages 200250 1 -2 years 216434 <1 year 128372 Patulin Data Analysis

26. With regulation excluding juice with >50 ppb 1-2 year olds: 90% of population consumes < 0.67 ug/kg per day (still higher than 0.43 ug/kg per day PMDTI)

27. FDA Regulatory Conclusion: 50 ppb in juice gives adequate protection “All Age” lifetime consumption gives 400-fold safety factor. 1-2 year old exposure slightly > PTDI, but has 64-fold safety factor. 1- 2 year old exposure levels occur for limited part of lifetime, therefore acceptable. Testing methodology would not support limit <50 ppb. Data interpreted three ways!

28. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 28 (Health and Welfare Canada) Mercury in Fish

29. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 29 Charge to Food Advisory Committee “…evaluate (in light of all the relevant literature about … consumption/exposure, … body burdens, hazard, and consumer messages) whether the … advisory on methylmercury is adequate to protect the health of those who follow … (it).”

30. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 30 Mercury in Fish - Issues  What constitutes “adequate protection?” of what population?  There is an established benefit to eating fish.  EPA has an advisory for “recreational” fish, FDA has an advisory for “commercial” fish.  Correlation of fish concentration, hair concentration, blood concentration, and “adverse health effect” concentration for mercury.

32. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 32 A woman that eats 12 ounces of fish with an average mercury concentration of 0.12 ppm (per week) has ten-fold safety factor.

33. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 33

35. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 35 Eating Fish is healthy Advisory’s Key Points Eating Fish is healthy But pregnant women, nursing mothers and young children should take precautions.

36. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 36 Pregnant women, nursing mothers and young children should…  not eat Shark, Swordfish, King Mackerel or Tile Fish.  eat up to 12 ounces of other fish such as shrimp, canned light tuna and shellfish per week. or 6 ounces of “white” tuna per week.  limit fish caught locally to 6 ounces per week.

37. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 37 JunkScience.com on the Mercury Advisory  “The FDA is warning (scaring?) us about a scenario that has, essentially, never occurred.”  No clinical proof linking fish consumption with illness.  12 ounces “arbitrary.” Would 13 ounces hurt? Would 130 ounces?

38. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 38 Food Fads, Facts, and Politics How to Sort Them Out

39. How to sort it out 1. Consider the source a. “Peer-reviewed” scientific literature, popular press or web site? b. Credentials of the scientist – have they ever published anything in the field? (Check Google Scholar) c. Follow the money (or agenda) ((Not always bad, if drug company won’t fund the research, who will?)) (((I’ve taken money from the food industry.)))

40. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 40 How to sort it out 2. Look for qualifiers and generalizations: might, can, possibly, potential, up to, etc

41. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 41 How to sort it out 3. Beware of Emotional Anecdotes

43. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 43 How to sort it out 4. Correlation is not causation There is a high correlation between eating pickles and dying. Everyone who has ever eaten a pickle died.

44. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 44 How to sort it out 5. Be number literate

45. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 45 dose “The dose makes the poison.” Dose = concentration x intake

46. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 46 Too much of a “safe” thing can kill you. “Woman dies from drinking tap water ” Excessive water consumption can cause hyponatraemic encephalopathy.

47. A little bit of poison can cure you. Before After

48. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 48 at There are lots of toxic compounds naturally present in foods at very low levels.

49. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 49 Green Salad TOSSED LETTUCE and ARUGULA with BASIL- MUSTARD VINAIGRETTE allyl isothiocyanate, caffeic acid, estragole ROAST TURKEY heterocyclic amines BREAD STUFFING with ONIONS, CELERY, BLACK PEPPER & MUSHROOMS ethyl alcohol, benzo(a)pyrene, ethyl carbamate, furan derivatives, furfural, hydrazines, psoralens, quercetin glycosides BROCCOLI allyl isothiocyanate BAKED POTATO ethyl alcohol, caffeic acid SWEET POTATO ethyl alcohol, furfural PUMPKIN PIE benzo(a)pyrene, safrole APPLE PIE acetaldehyde, caffeic acid, ethyl alcohol, quercetin glycoside, safrole COFFEE benzo(a)pyrene, benzaldehyde, benzene, benzofuran, caffeic acid, catechol, ethyl benzene, furan, furfural, hydroquinone, hydrogen peroxide, methylglyoxal American Council on Science and Health’s “Chemical Feast”

50. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 50 Beware of the 6. Precautionary Principle “If we’re not 100% sure, let’s wait.” Also stated: “Absence of (harmful) evidence  absence of risk.” but Zero risk does not exist.

51. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 51 The “Precautionary Principle”  Ignores potential benefits of new technology.  Diverts resources from real problems to hypothetical ones.  Makes hypothetical concerns more important than concrete benefits.

52. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 52 What drives people crazy? Concern = control x risk (Risk = hazard x probability)

53. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 53 Dread Involuntary Not dread Voluntary New, Unknown Old, Known What, me worry? Causes of concern

54. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 54 DNA Research Nuclear Power Herbicides, DDT Cycling Skiing BST Food Irradiation Hair dyes Jogging Motorcycles Firefighting Crime Smoking Dread Not Dread Unknown Known Anthrax (you) Anthrax (me)

55. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 55 Loss of Life Expectancy – Bernard Cohen, J. Health Physics THOUSANDS OF DAYS

56. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 56 Loss of Life Expectancy – Bernard Cohen, J. Health Physics

57. ______________ STATE UNIVERSITY OF NEW JERSEY RUTGERS DEPARTMENT OF FOOD SCIENCE Montville, IFT 2004 57 Take-home messages:  Be number literate.  Examine the underlying data.  Understand the process.  People overreact to dread-unknown risk, while ignoring “every day” established risk. (We drive down the road while talking on our cell phone as we check our hair in the mirror and eat out egg McMuffin®.)