Critical thinking in food safety                                                     Critical thinking in food safety Thomas J. Montville

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). Montville, IFT 2004

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. Montville, IFT 2004

You will be (are) a de facto 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. ?

What’s the harm in misrepresent in facts? False sense of security- can cause bigger problems Bigger risks ignored – or incurred. We drink bottled water due to worries about municipal water (pesticides, cancer, heavy metals). But bottled has few standards, Wastes water in manufacturing May have BPA. Bigger problems than water; obesity. Focuses on food, rather than exercise. Increased costs Unnecessary, and Ineffective Testing (McDonalds) Organic food costs 67% more Environmental damage of packaging vs. additives Biotech foods – cheaper (at least on the surface), may be better for the environment. (Nuclear power vs coal)

Are we spending enough on food safety? How much are we spending? USDA $797 million FDA $ 90 million Industry $ 90 million** Total $997~ 1,000 million What’s the first two things you should as about these numbers? Google Guess Montville, IFT 2004

Are we spending enough on food safety? Total spent $997~ 1,000 million Basis of comparison Population of U.S. (300 million) $ 3 per person # Illness (76 million) ~ $ 12 per illness # Death (5,000) ~ $ 20 per death $ Value of Food Industry $ 3.2 trillion 109/1012 = x/100 10% of food dollars Is this enough? Google Guess Montville, IFT 2004

Regulations result from “the facts” derived from “the best science available” economics practicality compromise politics Montville, IFT 2004

The problem with “facts”…. fact can be very dull (Inconvenient Truth) facts require interpretation Try to get at the data underneath “the facts”. Beware of statistics – try to get at the underlying numbers *Beware of ratios: The increased use of food additives, has caused 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%.

Look for the grain of truth. Take it with a grain of salt. Montville, IFT 2004

Therefore % due to cancer . Stats based on ratios can change because of numerator (top) or denominator (bottom). Examine % of children dying of cancer. Absolute number (cases/100,000 deaths) Infectious disease , infant mortality , industrial accidents , malnutrition  Absolute number (cases/100,000 deaths) of cancer cases remains unchanged. Therefore % due to cancer . Montville, IFT 2004

An important digression on “number literacy” One can’t explain what one doesn’t understand. Montville, IFT 2004

Think through the premise Homework #1 In Defense of Food, Michael Pollon stated that the average American consumes 300 more calories per day than they did in 1980. Is this credible? (3,500 calories = 1 pound) Montville, IFT 2004

Think through the premise Homework #2 It has been stated* that the American diet is so bad that the average American has gained 10 pounds since 1990. *Do not link this to the previous example. Is the weight gain a credible number? Does it constitute a real problem? How many excess calories per day would it take to cause this weight gain? Is there a non-dietary solution to this problem? Montville, IFT 2004

Homework # 3, a premise that looks good on the surface. In Defense of Food, Michael Pollon suggests that many of our problems due to the low cost of food. The US pay 10% of income on food while the French and Italians pay 15%. We’d be healthier if we increased the amount we paid for food by 50%. What do you think of this? Please do some research and use facts to support your opinion. Montville, IFT 2004

Approximate And identify or qualify your statement as “an approximate” or “within an order of magnitude.” Montville, IFT 2004

Cheat Approximate Scientific 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

Understanding the language. ppm is tiny – 1 inch in 16 miles  ppb is tinier- 1 cent in ten million dollars “fecal coliform” is not “feces” Montville, IFT 2004

Eating Bread Causes Cancer False reasoning: Furfural causes cancer Bread contains furfural Eating Bread Causes Cancer Montville, IFT 2004

Does eating bread cause cancer? 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 = 197,000 x 70 ÷ 167 = 82,600 slices of bread (dose) x (weight in kg) ÷ (amount per slice of bread) = slices of bread Montville, IFT 2004

T One (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. Montville, IFT 2004

Patulin in Apple Juice Would limiting patulin in apple juice to 50 ppb protect public? U.S. apple industry in favor of this regulation. (Why?) Several issues- -Does the public need to be protected? -How much of the population should be protected? -Will 50 ppm be enough? (Why not “zero?”) Montville, IFT 2004

Case Study 1 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 Montville, IFT 2004

Case Study 1 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? Montville, IFT 2004

Case Study 1 Patulin Data Analysis Juice Samples from Current Production Age Group Ave. Juice Intake (g/person/d) Ave Patulin Exposure (µg/kg-bw/d) 90th % Juice Intake (g/p/d) Patulin Exposure (µg/kg bw/d) All ages 200 0.094 250 0.22 1 -2 years 216 0.58 434 1.3 <1 year 128 0.50 372 1.1   Ae Group Mean Apple Juice Intake (g/p/d) Mean Patulin Exposure (µg/kg bw/d) 90th Percentile Apple Juice Intake (g/p/d) 90th Percentile Apple Patulin Exposure (µg/kg bw/d) 0.031 0.078 0.17 0.42 0.13 0.38 Remember, PMTDI = 0.43 ug/kg bw/d Is a regulation needed? Remember, PMTDI

Case Study 1 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

Food Advisory Committee Concerns Case Study 1 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? Montville, IFT 2004

Case Study 1 Patulin Data Analysis 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) 90th % Juice Intake (g/p/d) Patulin Exposure All ages 200 0.094 0.031 250 0.22 0.078 1 -2 years 216 0.58 0.17 434 (15 ounces) 1.3 0.42 <1 year 128 0.50 0.13 372 1.1 0.38 OK?   Mean Apple Juice Intake (g/p/d) Mean Patulin Exposure (µg/kg bw/d) 90th Percentile Apple Juice Intake (g/p/d) 90th Percentile Apple Patulin Exposure (µg/kg bw/d) 434

Case Study 1 Patulin Data Analysis 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) 90th % Juice Intake (g/p/d) Patulin Exposure All ages 200 0.094 0.031 0.04 250 0.22 0.078 0.10 1 -2 years 216 0.58 0.17 0.22 434 1.3 0.42 0.67 <1 year 128 0.50 0.13 0.13 372 1.1 0.38 0.27   Mean Apple Juice Intake (g/p/d) Mean Patulin Exposure (µg/kg bw/d) 90th Percentile Apple Juice Intake (g/p/d) 90th Percentile Apple Patulin Exposure (µg/kg bw/d) Montville, IFT 2004

Case Study 1 Patulin Data Analysis 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)

FDA Regulatory Conclusion: 50 ppb in juice gives adequate protection Case Study 1 Data interpreted three ways! 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.

Food Fads, Facts, and Politics How to Sort Them Out                                                     Montville, IFT 2004

How to sort it out Consider the source “Peer-reviewed” scientific literature, popular press or web site? Credentials of the scientist – have they ever published anything in the field? (Check Google Scholar) 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.)))

How to sort it out 2. Look for qualifiers and generalizations: might, can, possibly, potential, up to, etc Montville, IFT 2004

How to sort it out 3. Beware of Emotional Anecdotes Montville, IFT 2004

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. Montville, IFT 2004

5. Be number literate How to sort it out It’s mostly addition, subtraction multiplication, and division. Montville, IFT 2004

“The dose makes the poison.” Dose = concentration x intake Montville, IFT 2004

Too much of a “safe” thing can kill you. “Woman dies from drinking tap water” Excessive water consumption can cause hyponatraemic encephalopathy. Montville, IFT 2004

A little bit of poison can cure you. Before After

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. ipods, cell phones, computer screens

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. Montville, IFT 2004

What drives people crazy? Concern = control x risk (Risk = hazard x probability) Montville, IFT 2004

Causes of concern New, Unknown Not dread Voluntary Dread Involuntary What, me worry? Old, Known Montville, IFT 2004

Unknown Not Dread Dread Known Anthrax (you) Anthrax (me) DNA Research Nuclear Power Herbicides, DDT Cycling Skiing Food Irradiation Anthrax (you) Hair dyes Jogging BST Not Dread Dread Anthrax (me) Smoking Crime Motorcycles Firefighting Known Montville, IFT 2004

Loss of Life Expectancy – Bernard Cohen, J. Health Physics THOUSANDS OF DAYS Montville, IFT 2004

Loss of Life Expectancy – Bernard Cohen, J. Health Physics Montville, IFT 2004

Homework #4 Identify either something that causes concern but shouldn’t or doesn’t cause concern, but should. Discuss why. Montville, IFT 2004

Take-home messages: Examine the underlying data. 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 our egg McMuffin®.) Montville, IFT 2004