Coffee, Acrylamide, and Proposition 65 - Part 8

Here is something interesting that California states when discussing their current list of NSRLs for chemicals "known to the state to cause cancer:"

These safe harbor levels do not preclude the use of alternative levels that can be demonstrated by their users as being scientifically valid. A hyperlink is provided for those NSRLs or MADLs for which the documentation of their derivation is electronically available. (source)

That hyperlink acknowledges that there is information regarding a "derivation" from the established values written into law.

You will notice that there is no hyperlink for acrylamide and cancer. There is a document - the one I have been using - but California doe not link it. That document states this:

If you are good at the maths. you may know this already, but the larger the Cancer Slope Factor (aka Cancer Potency) the lower the NSRL value.

If it were me advising Starbucks et. al. I would have told them to do the following.

1. Find out the actual (statistically valid) concentration of acrylamide in YOUR coffee.
2. Find an adequately researched and recognized institution that claims a lower Cancer Slope Factor for acrylamide
3. Calculate the highest amount of acrylamide seen in the largest dose (cup) of coffee a customer can order.

If that "actual" concentration of acrylamide is less than the new calculated NSRL, plead your case based on California's own words:

These safe harbor levels do not preclude the use of alternative levels that can be demonstrated by their users as being scientifically valid.

Here's how I would do it using new data that I consider valid and demonstrated.

Based on what we know about the average amount of acrylamide in all coffees, we can assume the following for Starbucks:

Using the NSRL established in the March 2005 document, only the Venti would exceed the NSRL. And if "1" is a cancer risk of one in 100,000 and therfore, according to California, a "No Significan Risk Level, what happens when the amount of acrylamide in a Venti is 1.6 micrograms?

Let's go back to my Excel sheet and see if we can calculate the risk when we know the concentration of acrylamide in a Venti cup of coffee:

Okay, so using the Cancer Potency and the NSRL established in the March 2005 document, the added risk of cancer would be and additional 1.3 per 100,000. Since a one in 100,000 is considered a No Significant Risk Level, then are concern is for cancers over the one in 100,000, in this case we would say that we have a risk to consider of 1.3 additional cancers in a population of 100,000.

Remember, as California tells us...:

Cancer now occurs in nearly one out of every four individuals.

So by drinking a Venti each day for 70 years you jump from 25% to 26.3 percent.

But all of that assumes that the Cancer Potency California came up with is accurate. That is, is 0.7 a valid number and better than any other numbers that could be generated?

Let's take a look, shall we?

Source

What this bell curve shows is a bunch of computer simulations, 100,000 trials based on this:

Since acrylamide induced tumors at multiple sites in male and female rats, combined potency estimates were derived for each experiment using Monte Carlo analysis for those tumor sites judged to be associated with exposure to acrylamide. For each tumor site, a distribution of estimates corresponding to the 0.1 through 99.9 percentiles of the linear term (q1) of the multistage model was generated...

If - IF - those rat studies are valid, then the actual number is somewhere in that bell curve. Again, since they force the line linear with 0 as the risk and concentration, the Cancer Slope Factor is questionable. But since its all we got, let's roll with it.

Now if you are not familiar with statistics and bell curves, you need to know this. Between two standard deviations from the mean value (the highest peak in the bell curve) lies 95% of all the numbers it could be. COULD be.

California - to be safe - uses the upper 95% value which is two standard deviations to the right of the mean. That number is 0.70. Where have I seen that number before?



If I were advising Starbucks et. al. I would now get fired because everyone listening to me is bored and falling asleep. Still, I soldier on! I yell:

"If 0.70 is valid, well so is 0.20 because (pant! pant!) both of those number have an equal chance of being the real number with a 95% confidence. I mean...if you are going to say 0.70 is the number you can also say 0.20 is the number. Why do you get to pick the upper when the lower is just as valid?"

Now if the judge could channel King Solomon, he might say "Enough you two! Let's cut that baby in half - 0.50 looks pretty close to the peak - 50% for you and 50% for the state."

Aha! the judge fell right into my trap! I can support that number of 0.50. And if I can support it because California does not...

...preclude the use of alternative levels that can be demonstrated by their users as being scientifically valid.

,,,Then I win for Starbucks et. al. provided the judge agrees with my work.

So the question is, what makes 0.50 a number that you were hoping for Bowman? Well, let me show you...

EPA IRIS Acrylamide 

I think I could make a persuasive argument that the EPA IRIS presents "levels that can be demonstrated by their users as being scientifically valid."

So if I were to present 0.50 as the Cancer Potency (aka Slope), the my NSRL becomes...

And when we look at the estimated amount of acrylamide in a Starbucks coffee:

Close...but not out of the woods yet. This is why you need to know how much acrylamide is in a Venti. Why they did not go through this is beyond me. Had the amount of acrylamide been similar, they could have fallen back on their original defense. Had it been lower, they could have said "our coffee presents a NSRL for acrylamide."

Now, if I could get the judge to accept 0.50 as the Cancer Slope, the amount of acrylamide is above the NSRL of 1.4 micrograms per day by only 0.20 micrograms, which presents an additional risk above one in 100,00 as follows:

An additional 0.14 per 100,000 cancer risk for drinking a Venti every day for 70 years. I think I may have had a shot at this if I did not bore them to death.



Next Post: Coffee, Acrylamide, and Proposition 65 - Part 9 - The End!

Coffee, Acrylamide, and Proposition 65 - Part 7

Eight posts on this. Well if you are still reading we are getting close to the end.

Let's go back to this graphic:



If you will recall, I told y'all to pay attention to the writing in blue. The forcing of the line to have zero dose = zero risk is what sets the cancer slope (aka cancer potency).

To determine the concentration whereby you do not need to be concerned - the Not Significant Risk Level (NSRL) - and therefore are not required to notify the public that you have a substance "known to the state to cause cancer," you take the cancer slope value and you plug it into the formula below:

q(human) = cancer potency = cancer slope factor

Let's see how this works for a chemical called 4-methylimidazole. California has a nice document that spells out the Cancer Slope Factor (Cancer Potency) and the NSRL that was calculated using the formula I showed above.

California was nice enough to show their work for 4-methylimidazole so you can see how the NSRL was determined:

Source

You see that value of 16 micrograms in Table 1. You see the Cancer Potency in Table 1. You see the calculation for the NSRL in Table 1. You see the work, the formula, the values.

Can we agree on this as this is how you calculate the NSRL? 

You may be wondering why I am not using the same snip graphics from the California document for acrylamide.Well, that's because they don't show the work. Here is Table 1 for acrylamide:

Source

This looks just like Table 1 for 4-methylimidazole. You will notice that they give the NSRL for acrylamide as 1.0 micrograms per day.

Wait, I have been telling y'all that the NSRL for acrylamide is 0.2 micrograms per day. Where did that 0.2 number come form? It came from their webpage:

Source

I want y'all to know I don't make these numbers up. One of the reasons it take 7 to 10 posts is because I want to make sure the numbers presented are the numbers given.

So what is the NSRL for acrylamide? Is it 1.0 micrograms per day or 0.2 micrograms per day? What does the calculation for the NSRL show?

Source

Oh look! They did not show their work. Okay, I'll just calculate it myself using Excel:

Well, according to my calculation using their formula and their Cancer Potency value, the NSRL is 1.0 micrograms per day.


Let me make sure my calculation is calculating correctly. Ill use the values for 4-methylimidazole to see if I get what they got:

Okay, so my Excel formula works correctly. So where did a an NSRL of 0.2 micrograms per day for acrylamide come from?

The document from which these number came from that I plugged into my Excel formula is dated March 2005. These documents are how the state supports the numbers for the chemicals "known to the state...."  The "INITIAL STATEMENT OF REASONS" - also dated March 2005 gives the same cancer potency and NSRL of 1 microgram per day.

According to Title 27 for the California Code of Regulations §25705 "Specific Regulatory Levels Posing No Significant Risk" the NSRL is 0.2 micrograms per day.

It appears that, by citing 25705(c):

NSRLs may be based on: an assessment conducted by another state or federal agency (Section 25705(c)). (source)

Okay, then what is the March 2005 document all about? If they calculated the NSRL using a different Cancer Slope Factor (aka Cancer Potency), then where is the supporting data? Where did 0.2 micrograms per day come from?

Show your work!

Everything involving this court case, all the news articles, all the bloggers talking about it use 0.2 micrograms per day for the NSRL. Why? because that's the number that appears on the California Proposition 65 website for NSRL values.

Way back in 1992 this document had the Cancer Potency for acrylamide as follows:

Maybe they changed the Cancer Slope Factor (aka Cancer Potency) from 0.7 in 2005 to something else in 2018? Let's check the California Website for acrylamide to see:

Source

Wait...that oral slope factor is the one they used in 1992. Ahhh...I think I may know what happened. I think they got their apples mixed up with their oranges. Is it possible to have the same Cancer Slope for an inhalation dose and an ingestion dose? My thinking seems to be supported by this:

Historically, toxicity concerns over acrylamide centered on worker health and safety, primarily for neurological, male reproductive and cancer effects. However, in 2002 it was discovered that acrylamide can form during the cooking of starchy foods at high temperatures. This unexpected discovery shifted the concern for health risks to the public from acrylamide in the diet. Since 2002, acrylamide has been discovered in many plant-based foods that have been baked or fried at high temperatures. (source)

It appears though that this new look, March 2005, was not adopted into regulation so it still stands that the NSRL for acrylamide is 0.2. It should be, based on data - no lower than 1 micrograms per day as pointed out at the beginning of this post.

Now we can go all the way back to my first post on this. Is 0.2 micrograms a "real" number? Again, ya' gotta know that number because what ever that number is, above it presents a significant cancer risk according to California.

If 1 micrograms per day is a "real" number - or closer to the real number for a risk above one in 100,000 - then that Short cup of coffee - at 0.66 micrograms of acrylamide per cup - no longer poses a "significant risk" for cancer...based on how California looks at it.

This is why that writing in blue in the graphic at the top of the page is so critical to remember. millions of dollars are wasted over these NSRLs. It appears to me that the 0.2 micrograms per day established for acrylamide is wrong. legally it is correct, but calculation wise it is wrong.

Now add in the fact that the Cancer Slope Factor is derived by forcing the line from which the slope is determined mathematically, is assumed to begin at 0 risk and 0 dose.

Having fun yet?

Next Post: Coffee, Acrylamide, and Proposition 65 - Part 8

Coffee, Acrylamide, and Proposition 65 - Part 6

California contends that any product consumed that has less than 0.2 micrograms of acrylamide can be considered as presenting no significant cancer risk.

Cool...

Now let's look at Starbucks et. al. They sell a cup of coffee in California. Coffee, we are told, contains the chemical "acrylamide," and acrylamide is known to the state to cause cancer.

Scientists believe the acrylamide in food is a product of the Maillard reaction. This reaction occurs when sugars and amino acids are heated above 248° F, or 120° C. (Source)

Okay...

With that knowledge, a couple of things come into play. First, because the acrylamide shows up as part of the process in roasting the coffee, it does not meet the definition of "naturally occurring" (and therefore can be ignored.) Second, we are told that a product that contains less than 0.2 micrograms of acrylamide presents no significant cancer risk.

How much acrylamide is in a cup of coffee?

One single cup of coffee (160 ml) delivered on average from 0.45 micrograms acrylamide in roasted coffee to 3.21 micrograms. (Source)

Starbucks sells coffee in  Short (8 oz.), Tall (12 oz.), and Venti (20 oz.). 160 ml is equal to 5.4 ounces.

the smallest dose that we can get from Starbucks then is an 8 oz  cup.

So...we can assume there are 0.45 micrograms per 5.4 ounces or 0.08 micrograms per ounce.

Which means the smallest dose of coffee from Starbucks - a Short - contains 0.66 micrograms of acrylamide. That's 3 times more than the amount that California states presents no significant cancer risk.

This means that drinking a Short cup of regular Starbucks Coffee jumps from a one in 100,000 cancer risk to about three in 100,000.

Or, if the background chance of cancer in a lifetime for a population is 25% - one in four - then drinking one Short  cup of regular coffee from Starbucks - each day - for 70 years - jumps your chance of cancer from 25,000 per 100,000 up to 25,003 per 100,000.

That number - 25,003 is three additional cancers in a lifetime - 70 years - over a background of 25,000 cancers we expect to see - estimated from drinking a Short (8oz) cup of Starbucks everyday for 70 years. Hey, its possible.

That number - "three additional" - is only "real" if the math is correct. And therein lies the problem with all of this. Is the "three additional" not just probable, but even possible?

California tells us that:

The Proposition 65 “no significant risk level” (NSRL) is defined in regulation as the daily intake.

We discussed this in a previous post. The NSRL is the daily intake for which California tells us presents no significant cancer risk. It is the amount that our calculation tells us would present no more than one additional cancer in a 70 year lifetime per 100,000 people.

Where am I going with this? Let's look at what we are faced with when we look at acrylamide in something we consume. There will be a:

• Concentration that gives us one additional cancer is a "No Significant Risk Level - NSRL
• Concentration that gives us two more cancers, for a total of three, is a significant risk level and requires notification.

Up to 0.2 micrograms of acrylamide in your coffee is okay - no notification - no significant risk.
But once you exceed 0.2 micrograms in one cup sold, then you need to be notified of the risk.

The problem here is that California does not look at this risk in any form of degree. Once you exceed the NSRL you present a significant risk. Three in 100,000, 300 in 100,000, 30,000 in 100,000...are all looked at the same.

The question that I ask is this: Is the public better protected knowing that the acrylamide in a Short cup of coffee presents a three in 100,000 cancer risk? If a cancer risk of one in 100,000 presents "no significant cancer risk," then how much concern should there be when you jump to three?

And since we are so close in what is present and the NSRL, how confident are we in that number that claims no more than one additional cancer in 100,000? The difference between notification and not having to notify is a big deal for a company that sells food.

If you are going to spend time going to court and printing up notices, and working to convince the public are product is safe, then the number 0.2 micrograms per day had better be a real number.

Is it?

How did they come up with that number, 0.2 micrograms per day?

I'll show you...



We are going to spend the next post or two looking at the math. To get to 0.2 micrograms we had to know the cancer potency. What is that? Here is what California states:

Cancer potency factors may also be referred to as “cancer slope factors”. 

Once we know the cancer slope - the cancer potency - we plug it into that formula and it spits out the NSRL. 0.2 micrograms was derived from a cancer slope that was determined by forcing the line through the data so that zero dose = zero cancer risk. Right out of the box. we now no that the cancer slope is not a real number. It is a number that we agreed on because someone said at some time that any exposure presents a cancer risk.

So here we are in 2018 using that same line of thinking even though a lot of us think its wrong and carcinogens behave similar to non-carcinogens and not a straight line - linear - for 0 dose/0 risk.

To get to the NSRL of no more than one in 100,000 additional cancer risk, you need to calculate the cancer slope (cancer potency).

Let's have some fun shall we?



Next Post: Coffee, Acrylamide, and Proposition 65 - Part 7

Coffee, Acrylamide, and Proposition 65 - Part 5

In the case of acrylamide in coffee, how do we establish there is a "significant amount" of acrylamide "in the products they purchase?"

Based on what we know so far, California has established a "Safe Harbor" concentration of 0.2 micrograms per day. Any thing that is at this concentration or less in the "products they purchase" would never have to be disclosed.

That is, California has determined that your need to be warned ends when the concentration of the chemical presents a cancer risk of less than one additional cancer in 100,000. Less than 0.2 micrograms that would be consumed when using the product, would not require the warning:

“This product can expose you to a chemical [or chemicals] known to the State of California to cause cancer."

let's make sure we are all clear on this. 0.2 micrograms presents a cancer risk that California tells us that y'all don't need to worry yer perduy lil' head about this here chemical. Which means we go back to that proverbial line in the sand...

That line - threshold - for acrylamide is 0.2 micrograms per day. We don't say that less than 0.2 micrograms is "safe" what California claims is this:

...such chemical shall be deemed to pose no significant risk within the meaning of Section 25249.10(c) of the Act.

Section 25249.10(c):

 An exposure for which the person responsible can show that the exposure poses no significant risk assuming lifetime exposure at the level in question for substances known to the state to cause cancer...

So on the "Safe" side of the line in the sand lies acrylamide at a 0.2 micrograms/day concentration that "pose no significant risk."

Which means what for the other side of the line? If on one side it poses "no significant risk" does the other side of that line therefore pose a "significant" risk? If less than one in 100,000 is "no significant risk", is 1.01 in 100,000 a "significant" risk? What about two in 100,000?

Oh what a corner Proposition 65 painted us into.

This now requires us to get back into some math. That risk calculation of one in 100,000, or 1.01 in 100,000, or 2 in 100,000 is calculated based on that linear line we have discussed. Remember, that line is forced so that zero dose = zero risk.



Let's look at a recognized definition of cancer risk:

A slope factor is an estimate of a chemical’s carcinogenic potency, or potential, for causing cancer. If adequate information about the level of exposure, frequency of exposure, and length of exposure to a particular carcinogen is available, an estimate of excess cancer risk associated with the exposure can be calculated using the slope factor for that carcinogen.

...an estimate of excess cancer risk can be calculated...

 Specifically, to obtain risk estimates, the estimated chronic exposure dose (which is averaged over a lifetime or 70 years) is multiplied by the slope factor for that carcinogen.

So that number of 0.2 micrograms per day for acrylamide was determined as the dose that would get an “excess cancer risk” of one cancer above the background chance would appear in a population of 100,000 people.

Here is how the ATSDR guys define it for a cancer risk of one in 1,000,000:

Cancer risk is the likelihood, or chance, of getting cancer. We say “excess cancer risk” because we have a “background risk” of about one in four chances of getting cancer. In other words, in a million people, it is expected that 250,000 individuals would get cancer from a variety of causes.

This is a bit misleading here. Acrylamide risk is based on cancer from acrylamide exposure. We would need to know the background risk of the cancer associated with acrylamide. However, this still works as they are telling us that if you did not drink coffee your chance of cancer is 25,000 in 100,000. If you drink coffee with 0.2 micrograms each day, for 70 years, your chance of cancer is 25,001 in 100,000.

Here is how the ATSDR explains it based on the one in 1,000,000 cancer risk:

If we say that there is a “one in a million” excess cancer risk from a given exposure to a contaminant, we mean that if one million people are exposed to a carcinogen at a certain concentration over their lifetime, then one cancer above the background chance, or the 250,000th cancer, may appear in those million persons from that particular exposure. In order to take into account the uncertainties in the science, the risk numbers used are plausible upper limits of the actual risk based on conservative assumptions. In actuality, the risk is probably somewhat lower than calculated, and in fact may be zero. [ATSDR]

Here is what that calculation looks like for determining the Safe Harbor NOEL for a chemical "known to the State of California to cause cancer." This is how 0.2 micrograms per day for acrylamide was calculated. Note: The term "potency value = slope factor.



Now that we have that out of the way, let's look at the calculated cancer risk that California would claim is in one delicious cup of Pikes.


Next Post: Coffee, Acrylamide, and Proposition 65 - Part 6

Coffee, Acrylamide, and Proposition 65 - Part 4

My last post ended with this graph:

Source

Let's focus on that last statement in blue type.

Because we (us public health people who look at chemical exposure) have decided that any exposure to a chemical known, or suspected, to cause cancer presents a risk, once we force the data of the doses we use and the cancers we see to form a straight line from zero through our splatter of data points, we now get the ability to assign risk.

Yay for us!

Only problem is, this forced line from zero dose = zero risk, tells us that at some dose above zero we will have some particular risk.

Remember that this is based on the assumption that all exposure to a carcinogen presents a risk.

Some of us say horse feathers! Lest you think I am the only one, let's look at what this guy from the Department of Pharmacology and Toxicology, School of Medicine, University of Louisville, writes:

The linear plot for dose is very deceptive and compresses low doses so that evaluation in that range is impossible; however, this has not heretofore been clearly recognized. This paper is an attempt to demonstrate that deception and the difficulty in evaluating effects at low doses. 

Deception...

Interesting word choice, but that's what guys like me think about using a linear plot where zero exposure = zero risk and anything above that - even one molecule - presents a risk.

If that line we produce is deceptive, then the statement in blue presents a situation whereby the "Safe Harbor" dose may be deceptive. From that paper:

The thresholds that are demonstrated from the animal experiments can be used to calculate safety factors for human exposure. In some instances human exposures are at or very near the thresholds in animal experiments. This indicates that humans are more resistant to the carcinogenic effect of at least some chemicals.

What he is arguing is that we can look at carcinogens in a similar manner (non-linear) as we do non-carcinogens.

This means that the safe harbor Proposition 65 has come up for acrylamide - 0.2 micrograms per day - is only applicable if that straight line starting at zero is correct.

That concentration of 0.2 is derived using the slop of the line that they plot starting at zero does/zero response.

That concentration of 0.2 is considered Safe Harbor because it is the highest concentration per day where the cancer risk is less than one in 100,000.

Any situation whereby a person could consume more than 0.2 micrograms of acrylamide in a single dose (one cup of coffee) would therefore trigger the Proposition 65 warning notice:

Unless Starbucks et. al. could make an argument that a concentration above 0.2 micrograms per day is okay as an Alternative Significant Risk Level (ASRL) because the benefits of drinking coffee exceed the increase risk of cancer above one in 100,000.

Hopefully you can start to see the absurdity in this, although to be fair, we have not yet determined how much acrylamide could be consumed in that one cup of coffee and what the increase in cancer risk would be.

More math...yay!



Next Post: Coffee, Acrylamide, and Proposition 65 - Part 5

Coffee, Acrylamide, and Proposition 65 - Part 3

California's Proposition 65 does two things:

1. Proposition 65 requires businesses to notify Californians about significant amounts of chemicals in the products they purchase, in their homes or workplaces, or that are released into the environment. 
2. By providing this information, Proposition 65 enables Californians to make informed decisions about protecting themselves from exposure to these chemicals. 

Therefore, I want to focus on two things as I move through this. First, is the acrylamide a "significant amount" and second, does knowing that there is acrylamide in a cup of coffee above the "safe harbor concentration of 0.2 micrograms per day" protect the individual?

Where to start on this...

Okay, so we need to get a bit sciencey here. Then we will bring in some math (or "maths" as the kids seem to call it these days).

Two questions:

1. What is the risk of cancer if you drink Starbucks coffee?
2. Should you be concerned?

I am going to say "trivial" to the first and "no" to the second. However, I need to show my work as to why.

Let's first define what a risk for cancer is. We need to understand the definition as that's the foundation on which the number is derived. It's that number that determines if Starbucks must place a Proposition 65 warning for those who enter their store to drink their coffee. 

Full disclosure here, I drink Starbucks and it is my favorite coffee. So there's my bias front and center...

Let's look at the definition we use in the biz of protecting public health because of chemical exposure have decided on for Cancer Risk:

The potential for exposure to a contaminant to cause cancer in an individual or population is evaluated by estimating the probability of an individual developing cancer over a lifetime as the result of the exposure. This approach is based on the assumption that there are no absolutely “safe” toxicity values for carcinogens.

Here is where it gets messy. We (them scientists looking at chemical exposure and cancer) decided that there is always a risk of cancer when you are exposed to a chemical where cancer is an outcome.

I think this model is incorrect, but it is what we decided on when determining a "safe" level for exposure of a chemical suspected of causing cancer.

For most chemicals that we classify as carcinogenic, we assume a "linear response," that is, at zero dose there will be zero risk:

What does “linear responses at low doses” mean? These chemicals are assumed to have no threshold for effects, and even one molecule of the substance is assumed to confer some increase in the risk of contracting a cancer. [Source]

 As I have pointed out in previous posts, when we talk about non-carcinogen chemicals, we assume a "non-linear" dose response curve.

Basically, what this curve shows is that there is a dose that a person (child, adult, elderly) could receive where we would see no observed adverse effects. We call that a NOAEL.

The highest exposure level at which there are no biologically significant increases in the frequency or severity of adverse effect between the exposed population and its appropriate control; some effects may be produced at this level, but they are not considered adverse or precursors of adverse effects.

When we graph this non-linear dose-response out, it looks like this:

Source

You will notice that the graph starts at a dose of 7 mg before we start to see a response. Based on what we accept for non-carcinogens, in this graph, there is no difference between an exposure of a dose of zero mg up to 7 mg. This is know as the "threshold."

The threshold is the dose below which no effect is detected or above which an effect is first observed.

With carcinogens, there is assumed to be no threshold. Therefore, as stated previously, exposure to one molecule of the chemical produces a risk for cancer.

As this is the case, we assume that at zero exposure there will be zero risk. Since it is impossible to measure that, we take the data for cancer and dose that we see, and we force the non-linear dose-response curve into a straight line so that zero dose = zero cancer.

Source

Pay attention to that last bit there in blue type. That's important as we look at Starbucks coffee, cancer risk, and California's Proposition 65.

Next Post: Coffee, Acrylamide, and Proposition 65 - Part 4

Coffee, Acrylamide, and Proposition 65 - Part 2

In the court case, Starbucks et. al. made an argument for an Alternative Significant Risk Level (ASRL).

Specifically, Prop 65 allows an exemption to warning requirements even where the NSRL is exceeded if "sound considerations of public health support an alternative level" – for example, where "chemicals in food are produced by cooking necessary to render the food palatable or to avoid microbiological contamination." [Source]

The judge took issue with Starbucks on this matter stating that their claim was not supported by a "quantitative risk assessment" for acrylamide in coffee.

As I understand it, the ASRL is for situations where the potential harm of not consuming the materials because of the Prop 65 warning, outweighs the risk of cancer when consumed.

An example of this is arsenic that is naturally occurring in rice. A quantitative risk assessment could show that the benefits of consuming rice that may contain arsenic over the NSRL outweighs the elevated risk of cancer from one in 100,000 to maybe two in 100,000. I don't think I could make an argument where coffee has benefits that exceed a similar increased risk (from one to two). Starbucks did try:

Defendants argue there is no increased risk of any chronic diseases, including cancer, associated with coffee consumption.  In fact, defendants contend there is strong evidence that drinking coffee is associated with a decreased risk of several major chronic diseases, such as cardiovascular disease, Type 2 diabetes, liver disease, liver cancer and endometrial cancer. [Source]

How then, should Starbucks et. al. have approached this? I think it best to point out what is not going to fly.

First, if your stuff has more than the“no significant risk level” (NSRL) concentration that would be consumed in one unit, then you are out of luck. If you can reduce that concentration to below the NSRL, then Proposition 65 a "safe harbor level" and notification is not required.

Now this is where it gets a bit silly. The logic we use is this. There is a risk of cancer for any amount of a carcinogen one is exposed to. And by "any" we mean one molecule.

There is a risk from one molecule up to some hypothetical concentration where it becomes a 100% risk (yeah...not possible because some folks will not get the cancer, but work with me here...).

Now this "there is always a risk" is what we have decided on, but there are some of us (myself included) that think it creates more concern then is warranted. Look at the money being spent on this issue involving coffee. Look at how many people may - may - stop drinking coffee because the news media just wrote about Starbucks and their coffee containing a chemical that causes cancer.

Toxicologists have also used that scale for noncancer experiments but, for some unexplained reason, most authors of chemical carcinogenesis experiments have instead preferred a linear scale for dose. [Source]

I will get more into this in the following posts. For now, let's look at this.

If one molecule presents a cancer risk, and Proposition 65 allows for a "Safe Harbor" concentration and gives a company the ability to exceed this amount with an Alternative Significant Risk Level (ASRL), then in certain situations, California has decided you don't need to know that the chemical is present.

In other words, if a risk of one additional cancer in 100,000 is worth a warning, why isn't a risk of say three in 100,000 no longer needing to be stated just because the chemical is from a natural source or the benefit of consuming the product containing that chemical is seen as better for you than not consuming it (eat your veggies!)?

Remember that the cancer risk is based on the contaminant alone, not where the contaminant comes from or what benefits form other stuff in addition to the cancer chemical is there.

This then, begs the question of what is more important, knowledge of the risk or adherence to the letter of the law?

Next post: Coffee, Acrylamide, and Proposition 65 - Part 3

.

Coffee, Acrylamide, and Proposition 65 - Part 1

"California Judge Rules Coffee Must Carry Cancer Warning"

That was the headline in the Wall Street Journal on March 29, 2018.

LOS ANGELES—Coffee in the state of California must carry a cancer warning, a judge here ruled, in a blow to Starbucks and other retailers which had argued that a state law meant to protect consumers shouldn’t apply to them. [Source]

And with that decision, we get this:

Why? Because coffee contains a chemical called acrylamide and that chemical appears of the Proposition 65 list of chemicals "known to the state to cause cancer..."

California, way back in the mid-80s, passed a "peoples proposition...:

Proposition 65 became law in November 1986, when California voters approved it by a 63-37 percent margin.  The official name of Proposition 65 is the Safe Drinking Water and Toxic Enforcement Act of 1986.

...requiring business to:

...provide warnings to Californians about significant exposures to chemicals that cause cancer, birth defects or other reproductive harm.  These chemicals can be in the products that Californians purchase, in their homes or workplaces, or that are released into the environment. By requiring that this information be provided, Proposition 65 enables Californians to make informed decisions about their exposures to these chemicals.

The idea behind this proposition was that Californian's were being exposed to chemicals because they lived in proximity to, or worked at, businesses that released these carcinogenic chemicals.

Knowing this, a Californian could make the decision to move away, work elsewhere, or not consume/use a product in order to avoid exposure.

Sounds reasonable in principle, but in practice its a pain in the butt and, in my opinion, does little to zip to protect public health. It's a feel good regulation whereby knowing is considered powerful. However in reality, everywhere you go in California you see the warning so avoiding a carcinogen is dang near impossible, unless you want to live in a bubble, but then your own testosterone or estrogen will do you in - they are on the list too!

What we (I was there when this passed) ended up with soon became an OMG! There's a carcinogen in my purse, notify the people, alert!, alert!

We environmental people like to joke that everything in California causes cancer. We are not far off when you look at the list:

This list, which must be updated at least once a year, has grown to include approximately 900 chemicals since it was first published in 1987.

The reason there are 900 chemicals on this list is that there are a bunch of groups that look at chemicals and make a determination of carcinogenicity. There is a lot of differences of opinion when looking at chemicals. Some groups agree and others say not enough evidence.  California looks at this data, errs on the side of caution, and if they agree, put the chemical on the list.

Now the chemical in question here, acrylamide, has been on the list for ever.

It was not until 2002 that we quantified the amount of acrylamide that a person theoretically can consume in a cup of coffee.

With that information, the environmental groups that work tirelessly to save us for chemical harm, went after Starbucks and told them, "y'all need to put a Proposition 65 warning sign up."

The highest profile acrylamide cases have been filed against Starbucks and nearly 100 other coffee manufacturer and retailer defendants. After eight years of litigation, a ruling is expected within days to months. [and Starbucks lost...]

 Starbucks et. al. contends:

Defendants argue there is no increased risk of any chronic diseases, including cancer, associated with coffee consumption.  In fact, defendants contend there is strong evidence that drinking coffee is associated with a decreased risk of several major chronic diseases, such as cardiovascular disease, Type 2 diabetes, liver disease, liver cancer and endometrial cancer. [Source]

The judge in the case did not agree:

On March 28, 2018, Judge Elihu Berle issued a preliminary decision in favor of the plaintiffs in Council for Education and Research on Toxics v. Starbucks Corp. et al., BC435759 (California Superior Court, County of Los Angeles). In that case, the plaintiffs alleged that the defendants, sellers of ready-to-drink coffee, failed to warn consumers that the coffee exposed them to a known carcinogen – acrylamide – in violation of California's Proposition 65. [Source]

 dlapiper.com has a pretty good write up on the back and forth that went on. You can read it here.

What it comes down to is this:

• Acrylamide is found in coffee. 
• Acrylamide appears on the Proposition 65 list
• Acrylamide in a cup of coffee is greater than the No Significant Risk Level (NSRL) of 0.2 mg per day

So...should a coffee drinker be concerned?
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Next post: Coffee, Acrylamide, and Proposition 65 - Part 2

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