NPR does Arsenic, Apples, and Rice

On my way home from Texarkana I heard a short story on NPR regarding the FDA developing a threshold for arsenic in Apple Juice.

Here's some news for parents of the sippy-cup crowd: The Food and Drug Administration has proposed a 10 parts-per-billion threshold for levels of inorganic arsenic in apple juice. This is the same level set by the EPA for arsenic in drinking water. Right now, there is no FDA standard for apple juice.

Not this again, I thought.  I wrote about this...a lot, in a number of posts starting with this one for Apple Juice;  Apples, Arsenic, and Risk - Part 1: One in 500 and this one for rice; Arsenic in Rice: Part 1 - We Meet Again.

I am no fan of Dr. Oz and Consumer Reports for taking on this topic.  The science does not support their conclusion of risk.  All you gotta do is read my 30 or so posts to see that.  Or you can trust me, I write a blog.

My argument as to why it is bad science is based on this concept of toxicology:

If the dose is low enough even a highly toxic substance will cease to cause a harmful effect. The toxic potency of a chemical is thus ultimately defined by the dose (the amount) of the chemical that will produce a specific response in a specific biological system.

That's what they tell us on the Yale web page that defines the term "dose." That's the same thing Dr. Honeycutt with the Texas Commission on Environmental Quality (TCEQ) states:

The phrase, “the dose makes the poison,” is attributed to the ‘father’ of toxicology, Paracelsus (1493-1541). What he described was the dose-response concept and it is one of the fundamental ideas in assessing risk, in that, typically at higher doses the severity of an adverse effect increases.

I describe dose as a threshold and have shown it in my past posts as a line in the sand.

So the FDA is going to make "10 ppb" the new safe threshold.  Yay!!  Now apple juice that is less than that will be "safe."  Glad we got that settled.  So what's my issue?  Well for one thing - for the only thing in my opinion - that 10 ppb a'int based on science!

"We are pleased to see the Food and Drug Administration taking this action," says Urvashi Rangan, director of consumer safety and sustainability at Consumer Reports. "Proposing a 10 ppb guidance for apple juice — the same level set for water — is a reasonable first step in protecting consumers from unnecessary exposure to arsenic."

No, no it is not "reasonable."  Reasonable is based on the science of toxicology and risk. That 10 ppb in water, the MCL, is based on the safe dose of arsenic in drinking water.  That safe dose is derived from looking at the risk of 10 ppb in one liter of water.  It is based on a lifetime consumption of 2 liters of water over a 70 year lifetime.

Lifetime HA is for a 70 kg adult. The daily drinking water consumption for the 10 kg child and 70 kg adult are assumed to be 1 L/day and 2 L/day, respectively. The Lifetime HA for the drinking water contaminant is calculated from its associated Drinking Water Equivalent Level (DWEL), obtained from its RfD, and incorporates a drinking water Relative Source Contribution (RSC) factor of contaminant-specific data or a default of 20% of total exposure from all sources. (EPA)

Setting the dose - or safe threshold - for arsenic in apple juice to 10 ppb means that Consumer Reports thinks it reasonable that 2 liters of apple juice will be consumed for 70 years.  That's what I take issue with.  The safe level is not based on science and Consumer Reports should be basing their being "pleased" on science. Period

So what happened here?  FDA caved in to public pressure.  You can fight for science, but you are going to lose when science based organizations like Consumer Reports are incapable of grasping the concept.

Basically FDA found that almost all Apple Juice contains less than 10 ppb of arsenic anyway, so let's give the baby their bottle and make the safe threshold 10 ppb.  Done!.  But...but...that's not based on science.  Put a cork in it Bowman, this battle is over.  Science lost and the public is made stupider for thinking 10 ppb is "safe," but in the end, everyone wins.  Well, except science...

On the positive side, NPR just moved up a couple of notches in my book.  Well at least Allison Aubry did.

Here is how she summed it all up.

I would say, overall, Audie, for apple juice, I think the message is stand down. I mean, I can tell you as a mom of three children, from teen to toddler, I used to worry about all of these things. But if you look at the science here, if arsenic is limited down to 10 parts per billion, I think that this is something that we can mark off our worry list.

Thank you Allison Aubry...thank you!  That's exactly what I spent tens of thousands of words trying to show.  That sounds so good to hear her say that:

But if you look at the science here, if arsenic is limited down to 10 parts per billion, I think that this is something that we can mark off our worry list.

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Arsenic in Rice: Part 17 - The Ethical Considerations of a Threshold

Consumer Reports writes:

Consumers Union, the advocacy arm of Consumer Reports, urged the FDA to set a 3 ppb limit for total arsenic in apple and grape juice.

They are advocating for that level, which would then also be used for rice:

Using the 5-ppb [New Jersey] standard in our study, we found that a single serving of some rices could give an average adult almost one and a half times the inorganic arsenic he or she would get from a whole day’s consumption of water, about 1 liter. (CR)

Consumer Reports is advocating for a line to be drawn.  On one side the product will be "safe" - or - not  "troubling," "worrisome," "cause for concern," or "potentially harmful."  The question that needs to be asked is what will rice and apple juice that falls on the other side - more than 3 ppb - be called?

That's a question that seems to get brushed aside or, most likely, not even considered.  And here is where the ethical considerations of a threshold must be taken into consideration.

The reason that New Jersey decided that 5 ppb was "safe" for their water was because they could not effectively treat the water to anything below that.  Remember, their law demands a one in one million risk which means that the water would need to be treated to 0.003 ppb.  Not only is that not possible to treat down to, it is also not possible to analyze with any degree of precision and accuracy.

So New Jersey settled on 5 ppb as being reasonably able to attain:

This determination comports with the NJSDWA mandate to establish the MCL at the most protective level within the constraints of medical, scientific and technological feasibility. (NJ)

But that threshold is for water.  We can "waste" water if it cannot be treated, use it for non-consumption purposes.  That treatment option is not available for apple juice and rice that exceeds the threshold of 3 ppb.  So what would happen to it?  Would it need to be destroyed?  And if so, would the "wasting" of that apple juice, or more specifically rice, that contains 4 ppb inorganic arsenic be ethical?

First, let's settle on what I mean by "ethical":

Ethics refers to well-founded standards of right and wrong that prescribe what humans ought to do, usually in terms of rights, obligations, benefits to society, fairness, or specific virtues. (1)

The ethical consideration rears its ugly head when you draw that line in the sand.  If Consumer Reports wants a 3 ppb standard, what will be done with rice and apple juice that is found to contain 4 ppb?

If 3 ppb is "safe" then exceeding that number - appearing on the other side of that line is...what?

• We are not talking about water here.  We are talking about a food.  You cannot treat rice or apple juice that is found to contain 4 ppb of inorganic arsenic, so what do you do with it?

• Well we could blend it to dilute the total to below the 3 ppb - you know, the solution to pollution is dilution approach.  But that assumes that we have the capacity to store and blend this volume.

• We could just dispose of it, but that means that we take that rice out of the food supply thereby denying rice to citizens that can no longer afford it.  Economics 101 in play: supply and demand sets the price,

• We stop growing rice and apples in areas where the arsenic shows up in the samples.  Sounds good.  But you can't just plant an apple tree and start producing apples - it takes a long time to grow..  Nor can you grow rice anywhere - it take access to a lot of water.  Besides, look at the numbers for both apple juice and rice.  Arsenic is EVERYWHERE and in EVERY sample. It is ubiquitous with these two products because it is an element and it is in the water and soil cycle (see my previous post).

Well, that leaves us then with this.

• We could give it to poor people or starving people.  That's a better alternative for them.  If you are hungry, what difference does it make?  And in areas where food is short, those folks will die from starvation long before bladder cancer ever manifests itself.

If you draw a line in the sand at some ppb, you either dilute it, waste it, or give it to others when that threshold is exceeded.

You see the problem now with a line in the sand?  That line had better be bullet-proof or the ethical considerations that will come into play will rear their ugly head.  If you say 3 ppb is "safe" then wasting rice and apple juice when it contains 4 ppb will raise the cost of these two items and take them out of being consumed.  We can live without apple juice, but rice?

If you say that 4 ppb is not bad enough to waste, then where do you draw the line as to when it must be wasted?  And who gets to consume the 4 ppb product?  Do wealthy people get to eat the 3 ppb and less while the poor and hungry get the above threshold product?  Would that be fair?

Is that ethical?  Is that what we ought to do?

What will the rice and apple juice that exceeds the "3 ppb limit" be classified as?  Consumer Reports calls rice above 5 ppb "troubling," "worrisome," "cause for concern," or "potentially harmful."  If they push for a 3 ppb limit, as they are advocating for apple juice, then how can they justify a 5 ppb limit for rice?  Rice will therefore have to also meet the 3 ppb limit per serving to be "safe."

Here is what I want Consumer Reports to respond to:

1. What will rice and apple juice be considered if it exceeds the 3 ppb limit they urge the FDA to set?
2. What must be done to rice and apple juice that exceeds this threshold of 3 ppb?
3. Can rice and apple juice that exceeds 3 ppb be given to starving people and/or the poor, and, if so, how is that ethical?

And my final question:

• If exceeding the threshold is considered "potentially harmful" or to increase risk, how can we ethically allow anyone to consume this rice and apple juice?

The answer is you can't. Once you draw a line in the sand, anything that appears on the other side must be the opposite of what you want.  Safe: Unsafe, Healthy: Unhealthy, Toxic: Non-Toxic,  Okay: Not Okay, Good: Bad.

It is one or the other, it cannot be both.

So I'll end with this:

If you are going to draw a line in the sand, that line better represent a real risk if you step over it.  Does stepping over a 3 ppb limit represent a real risk?  Does eating a 1/4 cup serving of rice with 9.6 ppb inorganic arsenic represent a real risk?  If it does, then it is "potentially harmful."  If it does not, then it is safe.

It cannot be both.  This is why we must choose a threshold that represents a real potential for harm.  When you do, those ethical considerations become much more manageable when you exceed the threshold. We have an obligation to protect public health.  We have an obligation to feed people.  We have an obligation to look at the data and make sound decisions when setting a threshold of what is, and is not "safe."


Part 17 - Creating a Needless Concern.

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Apples, Arsenic, and Risk - Part 20: It is - and always will be - about the dose.

"All substances are poisons; there is none which is not a poison. The right dose differentiates a poison…." Paracelsus (1493-1541).

I hate to keep whipp'n that dead horse, but that's what is missing in these discussions on the arsenic that has been found in apple juice.  Let's look at what Russell H. Greenfield, MD says on the Dr. Oz website regarding arsenic in apple juice:

The 10 ppb level [arsenic MCL for drinking water] is simply as close as we can reasonably get considering our natural exposure to arsenic in the environment and other limitations. At that level, almost all experts agree our drinking water is quite safe.

Shouldn't the same goal or, at the very least, similar science-based exposure guidelines, be in place for the juices we commonly give to our children?

What goal would Dr. Greenfield want to see?  Consumer Reports thinks "the standard should be 3 ppb" and the FDA, on December 15, 2008, issued a memo on research they had done regarding arsenic in the juice:

In conclusion, the chronic consumption of apple juice products containing over 23 µg/L (ppb) inorganic arsenic would represent a potential health risk.

The FDA in 2008 says 23 ug/L is the maximum total arsenic in apple juice that would not pose a potential health risk.  That 23 ug/L is based on the actual dose a child would take in (uptake) based on how much apple juice is normally consumed.  That's the way it is supposed to be done, that's the way the FDA did it in 2008, so why does Consumer Reports, Dr. Oz, Dr. Greenfeild, and good ol' Chuck Norris think the FDA has dropped the ball on this?

Let's look at how the FDA came up with that:

Consumption estimates were based on average consumption over two days for individuals who consumed apple juice (eaters only) and were calculated for two population groups: Males and females (MF) from birth to 2 years of age and MF 2 years of age and older.  

The estimates included foods codes for products that were 100% apple juice, including infant apple juice; juice blends that included apple juice as an ingredient were not included.

Relying on results of the more recent 2003-04 NHANES, consumption of apple juice by MF birth to 2 years was estimated to be 16.7 and 36.2 g/kg body weight/day at the mean and 90th percentile, respectively, compared with previous estimates of consumption for all juices of 19.1 and 43.4 g/kg body weight/day.  

For MF 2+ years, consumption of apple juice was 6.0 and 12.9 g/kg body weight/day at the mean and 90th percentile, respectively, compared with the previous estimates for all juices of 6.0 and 13.0 g/kg body weight/day. 

Since consumption estimates from both surveys are similar, the level of concern (LOC) that was calculated for the previous assessment (23 ug/L, or ppb) can be applied in the case of apple juice. 

The 23 ug/L is for inorganic arsenic and is based on the dose a child would take in drinking apple juice.  The reason that number is higher than the 10 ug/L for arsenic in drinking water is that the dose from drinking water is estimated to be 20 ug at the 10 ug/L MCL.  This is because the MCL is based on drinking 2 liters of water per day.

What that means is this:

A 30 kg child (66 pounds) drinking 36.2 grams of apple juice per kilogram of body weight consumes 1086 grams of apple juice which is 1.1 liter.  That's the amount that will deliver the dose of arsenic.  That quantity of apple juice is the 90th percentile highest amount of apple juice estimated to be consumed.  A child drinking that much apple juice would receive 25.3 ug of total arsenic at a maximum FDA acceptable concentration of 23 ug/L.  The highest anticipated "daily dose" for this 30 kg child is 25.3 total arsenic from drinking apple juice.

For drinking water, that same child would consume 2 liters of water at the MCL of 10ug/L for a total daily dose of 20 ug.  That's what the EPA considers a safe dose.

So normal apple juice consumption will see less than 25.3 which is equivalent to what would be consumed if drinking two liters of water at the MCL for arsenic of 10 ug/L.

Drinking apple juice at a total arsenic concentration of less than 23 ug/L is the same as drinking water at the MCL 10 ug/L for arsenic.  The dose is based on the amount consumed per unit of fluid.  You drink less apple juice per day then water so apple juice can contain more ug/L of arsenic and still be considered safe.

Sounds counter intuitive, especially when you are talking about toxicity. We are concerned with the amount of the toxin - dose - received not the amount of the toxin found.  This is why you cannot compare the MCL for drinking water to the concentration of arsenic found in apple juice.  The MCL has been established for a dose based on consuming 2 liters per day.  You therefore need to compare the dose the receptor is anticipated to receive with the maximum dose - mg/kg body weight - established as "safe."

This is how it works.   It is - and always will be - about the dose when describing toxicity.

23 ug/L of total arsenic presents less dose than a drinking water MCL of 10 ug/L and is based on the assumptions of how much of each is consumed.  As long as the daily dose does not exceed 20 ug for a 70 kg person - or - 0.28 ug arsenic/kg body weight - we will not expect to see any short term or long term potential health risks over a 70 year lifetime!

That's why Dr. Greenfield states on the Dr. Oz website:

At that level [10 ug/L], almost all experts agree our drinking water is quite safe.

Even ol' Chuck Norris agrees with that, although I am pretty sure he has no idea that he does:

At the very least, the FDA should not allow more arsenic in apple juice than it allows in Americans' drinking water.

"Not so fast!" Yells our hero Chuck Norris, "tell them about the cover-up!"  No, Chuck, you tell them:

Tragically teetering on a huge U.S. health cover-up, the FDA posted eight "previously undisclosed test results" for apple juice samples from across the country that had arsenic levels that superseded even its own "level of concern" for inorganic arsenic. Two of those eight samples had an arsenic level of 27 ppb. One had a level of 42 ppb, and two others were at 45 ppb.

Tragically teetering?  Oh chuck, you are such the drama queen!  Here is what the FDA discloses in another memo dated November 21, 2011:

In July 2011, we issued an Import Bulletin to significantly increase the number of juice products sampled and analyzed for arsenic under the Toxic Elements program. Importantly, of the 74 samples collected as a result of this import bulletin, all were from China. Of these:

• 1 sample was above 23 ug/L total arsenic
• 1 sample was 10 ug/L total arsenic
• 2 samples were 11 ug/L total arsenic
• The remainder, (almost 95 percent), were below 10 ug/L total arsenic.

 Compare that to the arsenic levels reported by Consumer Reports.  But wait, there is more:

[we] now have a total of 160 apple juice samples collected from 2005 to 2011. These include 70 samples posted by FDA on September 27, 2011 and an additional eight samples that were part of this data set. These eight samples, which had not been previously posted, all have total arsenic levels greater than 23 ppb and were in the process of being further verified.

The data set also includes 82 new samples collected in the latter part of 2011 for which the data have just now become available. Of these 160 apple juice samples:

• Almost 88 percent had fewer than 10 ppb total arsenic
• 95 percent had total arsenic levels below 23 ppb total arsenic.

Okay...anything else from the lyin' stinkin' covern' up FDA?

Similarly, from the Total Diet Study program:

• Nearly 77 percent of the 134 composite apple juice samples tested from 1991 to 2009 (including baby food and general consumption samples) had total arsenic levels below 10 ppb.
• 95 percent had total arsenic levels below 23 ppb.

Cover-up?  C'mon Chuck, this ain't nothin' different than what Consumer Reports found.  How many samples do you need to have analyzed to get you to understand that we're not in any danger.  I mean, really Chuck?

Until then, tides of arsenic will continue to flow from foreign produce fields into American bloodstreams.

Tides of arsenic?  Chuck, Chuck, Chuck...

I have written 20 posts on this topic.  I have tried to show how many of these statements from Consumer Reports, Dr. Oz, and Chuck Norris are not substantiated.

As much as I believe we should consume food that is grown locally and with little to no pesticides, I cannot say that the reason for doing so is because foreign grown apple juice contains more arsenic than American. The Consumer Reports data shows that it does not.

I cannot support lowering the inorganic arsenic level to 3 ug/L.  There is no evidence to support that.  None.  Period.  The FDA's level of concern of 23 ug/L appears to be prudent, justified, and can be supported by the same data used to produce the drinking water MCL for arsenic at 10 ug/L.  And at that level, one more time courtesy of Dr. Greenfield:

"almost all experts agree our drinking water is quite safe."

It is - and always will be - about the dose received and not the amount detected.  You cannot compare the ug/L established for water with the ug/L found in apple juice.  This is no different than comparing a one pound ingot of lead with a one pound feather pillow.  They both weigh the same but one of them you would not want dropped on your head.

Let me sum it all up.  Here is how it works, it only works this way.

If little 2 year old Johnny weighs 66 pounds (30 kg) and he drinks the upper most amount of apple juice the FDA research found, 1.1 liters (36.2 g/kg body weight/day), and that apple juice contains the highest amount of total arsenic the FDA says is safe - 23 ug/L - he would consume 25.3 ug of total arsenic each day he drank 1.1 liters of apple juice.

That's a pretty big two year old and that's a lot of apple juice to drink, but that's a potential and I'm trying to force a "worst-case" scenario to illustrate my point.

25.3 ug for a 30 kg child comes out to 0.84 ug arsenic/kg body weight.  0.84 ug is 8.4E-4 mg/kg.

The IRIS reference dose (RfD) for inorganic arsenic is 3.0E-4 mg/kg-day.  Now before you say "whoa! That's more than double" remember this:

In general, the RfD is an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily exposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of deleterious effects during a lifetime.

Little Johnny will not drink more apple juice per body weight when he gets older, in fact, the FDA reports that after two years of age, a child drinks about half of that amount per body weight.  And as their body weight increase towards 70 kg, the dose of arsenic received per body weight gets less and less each day they consume apple juice.  So that at the end of 70 years, the dose of arsenic is around 3.0E-4 mg/kg-day based on a max of 23 ug/L.

Oh, and that worst-case amount of arsenic, 8.4E-4 mg/kg-day, is for total arsenic.  Looking at the Consumer Reports data, inorganic arsenic is about 30% less than that.

Nevertheless you may say, this worst case mega-heavy-baby little Johnny is consuming more than the IRIS RfD of 3.0E-4 mg/kg-day of inorganic arsenic based on these FDA estimates and calculations.

True that, but I have another little bit of information that will let me know everything will come out OK.  Even if little Johnny were to drink 1.1 liters of apple juice with 23 ug arsenic every day and never weigh more than 30 kg, the estimated dose of total arsenic - 8.4 mg/kg-day - is just barely above the NOAEL (No Observable Adverse Effect Level) of 8.0E-4 mg/kg-day listed by IRIS for inorganic arsenic and well below the LOAEL (Lowest Observable Adverse Effect Level) of 1.4E-2!

So is the FDA correct in identifying 23 ug/L arsenic in apple juice as a level of concern?  Yes.

Can the FDA substantiate their claim that:

...the chronic consumption of apple juice products containing over 23 µg/L (ppb) inorganic arsenic would represent a potential health risk.

Yes.

Is Dr. Russell H. Greenfield, MD correct when he says:

It remains very unlikely that you have done any harm to yourself or to your children through the drinking of apple juice. 

Yes.

Can you and your kids drink apple juice despite all of the misinformation and assumptions made by Consumer Reports, Dr. Oz, and Chuck Norris?

Yes.

Everything in moderation.

Now, how do you like them apples!


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