Can the FDA Assure Safety and Security of the Food Supply? Part 2 hearing

TUESDAY, JULY 17, 2007

Diminished Capacity: Can the FDA Assure the Safety and Security of the Nation's Food Supply? – Part 2
Subcommittee on Oversight and Investigations
9:30 a.m. in room 2123 Rayburn House Office Building
Witness List
Connect to the Video Webcast (100 kbps)
http://energycommerce.house.gov/membios/schedule.shtml

Witness list:
http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.071707.Witness%20List.pdf

Thanks to reader Mike for staying on top of this.
I'm of course hoping that someone will ask them timeline questions.

Also I'm hoping for some
"What did you know and when did you know it?" questions (It always seems to come back to that, doesn't it...)

As I've reminded people, the FDA has no recall power, except for baby formula.
So faced with a new problem (chickens and hogs that ate melamine and c-acid laden pet food) the FDA decided that instead of telling Big Chicken and Big Pig to recall the chickens and pigs, they "worked closely with industry" and created a risk assessment report based on, how shall I say this politely, weak science.

And guess what, the risk assessment said, "Sure send it out to the humans, based on old data from other species and not on any actual current feeding tests, the probability is low that it won't be a problem." Hey America, how does it feel to be Big Chicken's guinea pig? Would have been nice if we could have known when we were being used as a guinea pig right? So we could say, "I don't trust your "risk assessment" please tell me which chickens were the ones I ate.

But I always wondered, if it wasn't a problem then why didn't they tell us the NAMES of the big chicken farm that sold the chickens? Why didn't they say, "The chicken is as safe as houses based on our "risk assessment" so the company that is selling it to you is ____________."?

BTW, I'm pretty sure I know which one of the Big Chicken players it is, but of course after I alerted the advertisers to the violent rhetoric of the talk radio people and they shut down my blog and threatened me I have no desire to expose myself to the censorship games of yet another multi-billion dollar industry. (Hey, maybe I should tell people if they send me a self addressed stamped envelop along with $100 bucks then I can say, "You didn't hear it from me." )

Here's my questions that they won't get to because I don't have any real power (aka lobbyists whispering into my ear).

Did Big Chicken put the pressure on the FDA to create this "risk assessment" so that they could get the USDA stamp so they could sell to humans? What role did Big Chicken and Big Pig have in this process of determining the safety of the food that they probably didn't want to cull? Was that contact appropriate?

I wonder how they will respond. I mean it's not like they need to lie if you asked them. I'm sure they would just say that they were "working closely with industry". Say for example Big Chicken called the FDA and said, "Create a test so I don't have to kill 20 million chickens and 56,000 hogs." Would it be WRONG of them to suggest that? I'm sure that it would be seen as just a suggestion and it's not like they are trying to intimidate the FDA. I do wonder if there are some rules and guidelines that they are breaking-- maybe Lisa Shames and the wonderful folks at the GAO could tell us.

NOTE: We don't use the precautionary principle here. Therefore looks like we are going the China route. So I guess the rule is "If it's not EXPLICITLY going to kill you, go ahead and put it in. And then, if later, we find out that it DOES kill people, well then we'll stop."

I do hope one of the fine reps asks about the process of creating the risk assessment, and then asks, "Who's chickens were they and then where did those chickens and pigs get sent to?"

I'm sure they have a good answers, the best money can buy.

Updated and edited, draft was posted first. I blame Haloscan.

Paying Attention to New Orleans Pumps. Corp mistakes that Might cost Lives

Scout at First Draft has a great post up titled, Army Corps of Engineers Report: New Orleans Pumps still have mechanical flaws; also found contract improprieties check it out and also check out Matt McBride's, excellent blog "Fix the Pumps" for his engineering rigor (or any of my buddies in the New Orleans blogger community in my blog roll at the right. I dig them all, with special props to Gentilly Girl, Dangerblond and Humid City v. 2.3.


There is a view formulated by right-wing think tanks that if only government would get off their damn backs with demands for safety that everything would be better. That the "free market" will fix it all. That there are too many damn rules that are just a burden already.

But here's the thing. Rules and regulation are GREAT for businesses. Businesses NEED a working government. They NEED a working legal system. Competent government oversight is GOOD for the health of business. Just like a working media are good for government and business. The corporations will never admit this because, well then they would have to acknowledge all the good things they get out of rules, regulations, laws and a working government infrastructure.

I've heard some corporate executives say, "All I need is an unfair advantage."

Of COURSE they won't talk about the tremendous benefit they get from worker safety rules or government oversight, or contract regulations. Instead they find the excesses to make a point.

"Look how ridiculous this rule is! See how inefficient government is? What stupid requirements they demand!" Yes, there are ridiculous excesses, but there often is a reason for each and every one of the rules and regulations. Some company (or multiple companies) got busted badly and people got sick, died or will die because of a serious transgression. Or the corporation did life -changing economic harm to millions of people.

And the people cry out for justice.

"Where was the government at? How could the businesses get away with this? What kind of greedy monsters want to hide and cover-up information about poison in food?"

So then people become reluctant activists. I explain to them that they are working against a mind set and structure that has been developed and nurtured for decades. This mind set has been fabulously successful and its practitioners are highly-skilled and well paid.

These companies won't admit a failure even when their noses are rubbed in it, or if they do, it will have to be pro-forma admission of guilt which is Latin for "I don't really want to say this, but I will because I have to and secretly I'm glad I have to." (High school Latin scholars feel free to jump in here and comment.)


Corporations That act Like Children

People who study childhood development tell us that children need structure. Children have to learn what things will hurt them ("Hot! Don't touch! Don't play with matches! Careful! You'll poke your sister's eye out with that stick!")

Children will resist the warnings until they achieve awareness that the rules and warnings are for THEM and not some other children out there who are really bad. The rules they break are often designed to protect themselves and others. ("Don't eat that! It's poison! Don't feed that to your sister, it will kill her!")

I don't expect to hear children say (until years later) "Thank you Mother for not letting me eat that poison. Thank you Father for insisting I always wear protective goggles when woodworking." They don't have that kind of insight. But they should be grateful that someone insisted they do the right thing.

I clearly remember walking with a friend with toddlers in tow through the Air and Space museum in Washington D.C.. It was like the kids had no idea that gravity worked! They were ready to fling themselves off of high places or slip through gaps in the bars of railings overlooking the airplanes and space capsules. It was exhausting keeping an eye on them because they were constantly trying to evade our watchful eyes. Their quest to have fun looked to me like a constant attempt to kill themselves.

I mention all this because whenever there are calls for any regulation the cries of "Nanny state!" start. Any attempt at sensible guidelines or regulation are loudly shouted down under the guise of "there is too much regulation already!" They are then quietly shouted down with donations in the halls of congress. When we looked at something like the pet food industry we see that regulation to them doesn't have the same meaning as it does to us. But they know that throwing around the words "highly regulated" will stem the tide of criticism and bring out the defenders of all things "free" market and anti-oversight with real regulation.

Like a child they would never come forward and say, "PLEASE regulate me. I need the discipline!" Instead they will say, "I don't want any stupid rules. I'm going to pick up my toys and go to somewhere were their aren't rules." And because there are plenty of people and countries to choose from with cheap labor they will pick the ones that lets them follow the least amount of rules.

And then when some of them grow up (usually after something bad happens) they realize that those pesky rules were there for a purpose. They can see that a working infrastructure legal system, food safety, human safety or financial guidelines were actually good for them. But now they are addicted to the rhetoric, stuck in the groove of decades. Fighting the previous battle and imaginary excesses and some rare real exceptions.

I use the"business as child" metaphor because if I didn't, it would be too hard to contemplate.

Imagine people in business or supporting businesses who actively work to make it possible for MORE horrible acts to happen? I can't imagine people sit around and decide to cover up or support poison in food. People who, instead of addressing the problem, argue that the problem doesn't exist or question the credibility of the critic. What kind of people would do that?

Can you imagine someone calculating that X number of people or pets might die because of this, then asking "What do we had to do so that we can get away with it?" I just don't think that most humans would say, "Who do we have to hire to cover this it up, to make it go away and shut up the critics?" Normal people don't think that way.

If these people exist, surely they must not be lionized. Surely people whose job it is to draw focus from the problem, aren't aware of what they are really doing. I think that those people, if they are involved, will make weak arguments in a desperate hope that that they will be seen as a sham. I would think that these people would quietly do the right thing to maintain their personal moral high ground. But I do understand the power and pressure of the child and their self-centered world view. The Child will scream "I hate you!" to the parent who tells them, "No! You can't feed your sister that. It will make her sick!"

If there are people at the highest levels making this all possible, how would you react to them? Should they be praised? Excused? Rewarded? Vilified? How should they be treated by other humans? And what about the people who assist them knowingly? What role do that play? What culpability do people with full awareness have? People who know something is wrong and do it anyway? But I'm just a brain in a box. I live in the internet. I don't get out much, so I don't know the ways of the world.

When time in measured in nano-seconds, I wonder how much time should be given to people to act in a manner that is befitting of the label, human being?

Question for Dr. Kenneth Petersen. Whose Chickens are They?

A very simple question for:

Dr. Kenneth Petersen, assistant administrator for field operations with the Food Safety and Inspection Service at the U.S. Department of Agriculture. OR

Terri Teuber, USDA spokeswoman or
Mike Johanns, Agriculture Secretary or
Julie Zawisza, assistant commissioner for public affairs or
Dr. David Acheson, the assistant commissioner for Food Protection, FDA.
This is regarding the millions of chickens that ate tainted feed. (story here)

Q. If the 20 million chickens are safe to eat, what are the names of the companies who are selling these chickens to the public?

• If you won't tell us, why not?
• If you don't tell us, does that mean they really aren't safe?
• What about the 3.5 million chickens that when out in February? Who sold those to people?
• What rules are you following regarding disclosure of this information?
• Did you cut a deal with the chicken processor(s) to not name the names?

Agriculture Secretary Mike Johanns said this during comments to the Organic Trade Association.

"We literally found that the dilution is so minute, in fact in some cases you can't even test and find melamine any more in that product," (link)

Great Mike, sounds grand. Now who is selling this chicken? Where can I buy it? It sounds like the Safest. Chicken. Ever.

Since I'm not allowed to ask the question in your press conference, I'm hoping one or more of the team of journalists will use one of their precious questions to get this answer. And when the question is dodged, maybe another journalist will use their ONE precious question to ask it again. And again. Because really, if it's safe enough to eat, why wouldn't you tell us the names? Oh and don't forget which lots, which dates and shipped to which stores.

Maybe the public has a right to know where to buy the Safest. Chicken. Ever.

Below is a list of folks who are playing this game of chicken with the USDA and FDA. The USDA and FDA have held back information until they could put out the, "Melamine Chicken: It's safe as houses" press release. Next the FDA/USDA will dance around the question of whose chicken was processed and whom did they sell them too. I'm really curious to see which spin they will use. These are my guesses:

• We don't know
  
• It's proprietary information
• It's irrelevant since all chicken is safe. Trust us. Trust our assumptions.
  
• It's not really important
• There is no difference between this chicken and regular chicken, therefore it would be irresponsible of us to single out a single processor

My money is on the last one, it has the right mix of arrogance and deference to the honchos in the chicken biz.

Some of the press following this are very sharp (see list below). The USDA and FDA are treating the media (and the public they represent) like they are ignorant of science, politics and how the world works.
Frankly I have great confidence that a few of these folks WILL get to this question. And maybe they will get to some of these other questions in dark blue from my "Calling all science journalists" post.


Abigail Goldman with Los Angeles Times.
Deidre Henderson.Boston Globe.
Joe Johns with CNN
Randy Schmitt, Associated Press
David Curley, ABC News
*Julie Schmitt, USA Today.
*Elizabeth Weiss, USA Today
Nancy Cortis, CBS News or
*Dr. Debbye Turner, CBS Early Show
Brooke Turnbulle, or Dan Grutnech from CNN
Loren Edder, Wall Street Journal
*Steve Hedges, Chicago Tribune
Susan Heedy, Reuters.
Bill Tomson with Dow Jones
Andrew Martin, New York Times
John Rockoff, Baltimore Sun
Heather Harland, NHK Japan
*Karen Roebuck, Pittsburgh Tribune Review
David Brown, Washington Post
Steve Osbey, The Greenville News
Alan Bjerga, Bloomberg News

J.M. Hirsch, Associated Press

(list and spelling from the May 3 2007 transcript of the conference call)
* These are the folks that I have the most confidence in asking sharp questions to get to the truth. If only Christie Keith, from PetConnection were allowed to ask questions. Sigh.

Calling all Science Journalists.Notes for the FDA 5/8 press conference

At the Vulcan Science Academy they don't teach human spin.

I know that there are some good journalists out there that know both science and human spin who can understand what is going on in this press release below. Based on my years of observing humans I'll take a crack at it. Anyone want to jump in, go ahead. Or better yet, ask the FDA one of these questions. But be smart about it because the FDA and the USDA are better at dancing than Gene Kelly in Singing in the Rain.

The FDA knows how to control the press in their press conference. How?

1) Press conferences are short, only one question is allowed, there are no follow ups allowed. They control the phone lines so you CAN'T ask more than one question. Why? Because a focused group of people would bust them for their vague answers to questions.

2) Only "credentialed press" even get to ask questions. This doesn't include the bloggers who have been following this crisis for weeks. And even the credentialed press get blocked if they aren't high status enough. For example, Christie Keith of PetConnection is blocked from having her questions asked because the high status press had to have their questions asked first.

Christie has better questions and has been tracking this story from day one. She was graced with access but didn't get to ask her great questions because she has busted the FDA twice for not having the right info. She is being treated like Helen Thomas and relegated to the back row because she asks the tough questions. Frankly this is bullsh*t. The FDA/USDA should keep the press conference going until all the questions are asked and everyone is satisfied with the answers.

This whole process is backwards. Instead of simply saying, "We are asking for a voluntary recall the pigs and chicken." they are saying:
"We are going to try and convince people that the chicken and pigs are safe to eat."

Why are they going this route? Because the 3.5 million chickens are already in your belly folks. But they won't tell you who ate those 3.5 million chickens. So they are working very hard to try to prove what you ate was safe. This also has the added benefit of pleasing the swine and poultry industry. They don't want to lose the money from the 20 million chickens.

They are rolling the dice with your health. Thanks FDA and USDA for looking out for our health first (sarcasm smilie here)

Horse gone. Barn door closed.

--------------------------------------------

Here is the press release I've made my comments in quotes.

Scientists Conclude Very Low Risk to Humans from Food Containing Melamine
USDA Releases Some Swine and Poultry for Processing


WASHINGTON, May 7, 2007 – There is very low risk to human health from consuming meat from hogs and chickens known to have been fed animal feed supplemented with pet food scraps that contained melamine and melamine-related compounds, according to an assessment conducted by scientists from five federal agencies.

In the most extreme risk assessment scenario, when scientists assumed that all the solid food a person consumes in an entire day was contaminated with melamine at the levels observed in animals fed contaminated feed, the potential exposure was about 2,500 times lower than the dose considered safe. In other words, it was well below any level of public health concern.

The extreme risk assessment scenario questions:
1) How safe is safe enough? Show the public the scenario, now. We need to be able to interpret the statistics and identify the assumptions. If we don't, then they can hide behind statistics and assumptions. Some questions to ask:
a) Was this assessment based only on consuming melamine? Remember, there are three other chemicals, NOT just melamine. And they reacted with urine.

b) Was any of the pig or poultry food contaminated with wheat, rice or corn gluten DIRECTLY?
They talk about a proportion of pet food given to the poultry. But we know that China created feed just for poultry too. Did any suppliers to the 38 farms give poultry feed that was formulated from contaminated gluten alone? Since we don't know the farms, we can't call them up and ask. "What did you feed them? Where did you get it? Who sold it to you?"
Remember, the 3.5 million birds went out in February. That was long before the recall. Give me names of companies who created the food for the birds and pigs so we can ask THEM what they put into their food.

2) When will they release their risk assessment document? Before or after they release the birds to the chicken eating public?

3) What dose is considered safe? Were these safe dosage tests done on humans or rats? They are probably using an old study based on rats eating melamine only. Melamine alone is NOT the problem.

The risk assessment is an important new science-based component of the continuing federal joint investigation into imported wheat gluten and rice protein concentrate from China that contained melamine and melamine-related compounds.

Risk assessment covers a lot of ground, calling it science-based sounds more scientific I guess. But it really includes a lot of statistics in it and numbers ("too many numbers"?) maybe Kelley B or one of my other real science-talking readers could comment on this.

The risk assessment was conducted by scientists from the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) of the Department of Health and Human Services (HHS), the Environmental Protection Agency (EPA), U.S. Customs and Border Protection (CBP) of the Department of Homeland Security (DHS) and the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA). This team is now compiling a scientific assessment of the risk to animal health associated with ingestion of animal feed containing melamine and its compounds.

Who are the independent scientists who will be reviewing this assessment?

FDA and USDA are in the process of identifying a group of experts to convene a scientific advisory board that would be charged with reviewing the risk assessment. This group would also be asked to contribute to future scientific analysis related to the risk of melamine and its compounds to humans and animals.

And this "group of experts" comes from which industries? Who pays their bills? Agribusiness, the pet food industry? The chemical industry?

In the course of the investigation, it was discovered that pet food was contaminated by wheat gluten and rice protein concentrate that contained melamine and its compounds. Subsequently, scraps of contaminated pet food that contained only low levels of melamine were distributed to farms in a limited number of states and added to the feed consumed by swine and poultry. These scraps constituted only a small percentage of the farm animal rations. In addition, melamine is known to be excreted in animal urine. When exposure levels are much higher, as was the case with cats and dogs, the melamine and its compounds appear to cause the formation of crystals in the kidney systems, resulting in kidney damage. There was no indication of kidney damage in hogs. Both hogs and chickens known to have been fed contaminated feed appear to be healthy.

"Melamine is known to be excreted in animal urine."
1) Which animals? Rats? Cats? Dogs? Pigs? Humans? (Lions? Tigers? Bears? Oh my!)
Is ALL of it excreted? No. With pets the melamine and other chemicals caused vomiting and crystals to form in kidneys. Some was still excreted. That's not the point. When I take Vitamin C it's know to be excreted in my urine. (Ever take too much and pee bright yellow?) that doesn't mean that I don't absorb enough of it to make an impact on my body, just that the excess is excreted. And different animals react different to chemicals. Rats have a more robust digestive track than other animals.

This dilution factor was an important piece of data considered in the multi-agency science-based human risk analysis and helps to support the conclusion that there is very low risk to human health from eating meat from animals that were fed the contaminated product. This conclusion supports the decision announced on April 28 not to recall meat from animals that were fed contaminated product.

Where have I seen a conclusion made to support a decision that has already been made? That's right, The Downing Street Memo, where the "facts are being fixed around the policy."

And what about the accumulation factor? This dilution factor is based on assumptions in which they have no physical evidence. That's hope, not science. See their FAQ where they admit they don't have data.

A safety/risk assessment is a scientific approach to estimating the risk to human health from exposure to specified compounds. It is based on available data and certain scientific assumptions in the absence of data.

Currently, swine and poultry on farms suspected of receiving contaminated feed are being held under state quarantine or voluntarily by the owners. In several cases, feed samples have tested negative for melamine and related compounds. These tests were conducted by federal laboratories or state laboratories using approved methods. It is assumed that because only small amounts of the contaminated feed were mixed with other rations, the melamine and related compounds were no longer detectable. USDA has concluded that, based on the human risk assessment and the inability to detect melamine in the feed samples, these animals no longer need to be quarantined or withheld from processing.

Again with the assumptions! Is all this hoop jumping really necessary for 20 million chickens?
Or are they preping us for 200 million chickens who ate bad feed and trying to excuse the 3.5 million melamine and c-acid contaminated chickens we already ate?

In other cases, feed samples have tested positive for melamine and related compounds; feed samples were not available; or feed samples have not yet been submitted for testing. These animals continue to be withheld from processing, but are not yet being culled, pending the results of the animal risk assessment. This assessment is expected to be completed within one week. At that time, USDA will determine whether these animals can be released for inspection and further processing.

USDA and FDA continue to conduct a full and comprehensive investigation. As additional information is confirmed, updates will be provided and decisions will be made using the best available science to protect the public's health.

Is this really about protecting public health or is it about protecting the poultry and swine industry? The US demanded that China kill millions of birds to stop Avian flu because they were afraid it would jump to humans even thought the "risk assessment" was very low that eating the dead birds would cause bird flu. Why the different standard on this?

To ensure no further contaminated products enter the U.S., the federal government will continue to monitor imported wheat and corn gluten as well as rice protein concentrate and isolates arriving from all countries destined for human and animal consumption. The FDA import alert for these products sourced from China remains in effect and U.S. Customs and Border Protection will continue laboratory testing of the products as they enter the U.S. The inspections are a precautionary measure to ensure the safety of products entering at U.S. ports of entry. There is no evidence to suggest products bound for the human food supply are contaminated.

"No evidence to suggest." Okay, could you please tell us the story about how the FDA caught products that WERE bound for the human food supply? Bet a lot of you in the press don't know that story. Maybe someone should ask it, might prove useful to remind people that we KNOW of cases where tainted gluten DID get into the human food supply, but just didn't get delivered to the stores.
That kind of throws a hole in the FDA's line.

For additional information about the pet food and contaminated feed investigation, go to www.fda.gov or www.usda.gov. The human safety/risk assessment will be available online upon completion of an executive summary.

Great. Again I ask this be before or after you release the birds on the chicken eating public?