Itchmo liveblogged today’s Subcommittee on Oversight and Investigations hearing: “Diminished Capacity: Can the FDA Assure the Safety and Security of the Nation’s Food Supply? â€“ Part 2.”
This is not a transcript, but a report of the event.
Here is the witness list for the hearing:
Mr. David Nelson, Senior Investigator, Committee on Energy and Commerce
Mr. Kevin S. Barstow, Investigative Counsel, Committee on Energy and Commerce
Mr. Richard A. Wilfong, Investigator, Committee on Energy and Commerce
Ms. Caroline Smith DeWaal, Director of Food Safety, Center for Science in the Public Interest
Mr. Charles R. Clavet, Microbiologist/IVD Specialist, Winchester Engineering and Analytical Center
Mr. William K. Hubbard, Former Associate Commissioner of the US Food and Drug Administration
Ms. B. Belinda Collins, Director, Denver District
Ann M. Adams, Ph.D., Director, Kansas City District Laboratory Food and Drug Administration
Richard Jacobs, Ph.D., Chemist/Toxic Element Specialist, San Francisco District Laboratory Food and Drug Administration
Ms. Carol A. Heppe, Director, Cincinnati District Food and Drug Administration
Andrew C. von Eschenbach, M.D., Commissioner, Food and Drug Administration, Department of Health and Human Services
Mr. Stephen R. Mason, Acting Assistant Commissioner for Legislation, Food and Drug Administration
Ms. Margaret O’K. Glavin, Associate Commissioner for Regulatory Affairs, Food and Drug Administration
Robert E. Brackett, Ph.D., Director, Center for Food Safety and Applied Nutrition, Food and Drug Administration
Special Announcement: Re: treatment of meat with carbon monoxide
Safeway sends letter to stop selling treatment of fresh meat treated with carbon monoxide. Thanks to Safeway
the steady stream of food safety disaster has continued: first, spinach tragedies, then outbreak of life threatening diseases in peter pan, then 100s of deaths of pets of contaminated wheat gluten, then melamine tainted animal feed, toothpaste, veggie booty
Then we enlisted a food czar, Dr. David Echeson– we promoted him.
food safety was recently called as broken- investigations have proved that this is true.
FDA field personnel have been up front about gaping holes. FDA inspects less than 1% is inspected and only that percentage is testing for contaminants. These private labs do testing and some investigators say that private labs is shoddy and not reliable.
Food safety program is understaffed. Investigators cannot keep up with the pressure of the food safety.
Some companies are importing through ports that have no FDA investigators. Several FDA employees were worried about retaliation and have not decided to testify.
This hearing will be used for reform
Whitfield speaks: (Kentucky)
-headlines of food safety have been coming from China
-in 2004, bogus baby formulas have killed infants in China
-in May, the head of the FDA was arrested and was then executed - but we don’t know what happened to the people that did the bribing
-20% of their domestic products have failed to meet safety standards
-the FDA is responsible for 80% of the food’s supply, but only has 20% of food safety budget. Dept of Agriculture has most of the budget.
-FDA’s budget declined from half to budget to quarter of FDA’s budget
50% of American food is imported
-10 million import entries in 2006, and only 1% of those were examined
-FDA needs to adopt a risk based program — FDA lacks resources for risk-based program, recall info and public info are not used to figure out which shipments to inspect
-FDA should establish online training course to other companies for good manufacturing processes
-Congress should pass law that FDA can enforce companies that do not follow standards even in other countries
Inslee (Washington) speaks:
-who needs terrorists when you have e.coli? who needs them when you have melamine?
-if it was terrorists, we would actually act. we have to take some action. if we spent 1/10 of the money and effort on the war on terrorism that we spent on food safety, we would replace at least 1/10 of the amount of food poisonings
-risk based program would be effective and I will be investigating that option during my questioning
Barton (Texas) speaks:
-when we have a problem in this country, we try and solve it with civil means, hopefully we won’t come to what China did by executing their ex-chief of the food and drug admin
-we have to take a new look at this and we have to do this in Congress
-ideas: FDA needs to make info about good manuf practices available to foreign food agencies and processes, consider training courses onsite and through internet on basics of safe manuf, translate into other languages,
-FDA needs to give more info about food safety risk by profiling agencies in all countries- this would allow FDA to better manage its resources
-separate foreign and domestic activities- treat foreign inspectors as a stepchild- need to have a sep agency of foreign investors that become specialized in foreign govts and agencies
-FDA needs performance standards to figure out progress- FDA has not had a performance plan over the past three years
-want FDA to be accountable- FDA system needs to be on solid legal ground- and needs to work with Congress on appropriate legislation
Greene (Texas) speaks:
-events of the past three months have only brought questions instead of answers
-FDA isn’t meeting their mission of protecting food safety.
-imports have increased by 400% over the past year
-FDA seems to be holding important info from committee- we expect full compliance
-troubled by info that the US imports $2 billion of imported seafood from China and China is the #1 country that we import seafood from
-we’re concerned that terrorists in our food and that there could be harm from abroad
-US is expected to import $70 bil of Agri products in 2007 and this is double of the amount in 1997
-last year, we were a net importer
-we need to seek greater accountability in FDA’s antiquated processes- they need to enter the 21st century with their procedures
-the FDA has to transition from defense to offense and implement risk based program- we need to work with countries - must focus on maximizing its resources, need more communication with different branches, make changes necessary to policing food supplies
-this brings this issue that we rely on other countries for the safety of our food
-the FDA is reactive and doesn’t catch tainted food before it causes death
-5,000 people will die from tainted food each year
-we can’t rely on China to come up with solution- they lack the will to overhaul a political structure and will not fix a system plagued with corruption
-we must change the way that we inspect food and ingredients -
-we must make sure that FDA has the resources - the FDA has gaping holes in their system, the FDA is closing 7 of its labs amidst these food safety problems
-at first hearing, we heard why we are doing this -stories of children that have become ill from tainted food
-the FDA has been far from forthcoming of these incidences and not cooperative with investigations and why FDA hasn’t been proactive
-in light of the problems of FDA’s oversight with food, now the FDA is proposing to close half of the food and safety drug laboratories
-closing the Denver lab would affect 50 microbiologists and analysts - they are important to our food safety
-why are they proposing to close labs that are important and this would be a risk to our human food safety
- FDA rated Denver lab was in good condition and is proposed to close down while the Atlanta lab is in fair condition and will remain open
-despite the evidence of the Denver lab’s effectiveness, the FDA continues to propose to close down this lab and others
-and this would cause a loss of employees with years of evidence in food safety
-the FDA doesn’t seem to be compelled to answer questions that we have had - I’ve had no response to any questions that I’ve had
-why do we have these hearings? usually there is some new revolution and something is fixed- now Safeway has announced that they will not be using carbon monoxide
-the FDA isn’t doing enough to protect its citizens from tainted food, but Congress hasn’t done its part either that FDA has the authority and resources to do their job well
-the FDA lacks the authority to get companies records, lacks authority to detain tainted food- this makes FDA reactive
-Congress hasn’t given FDA the resources- FDA oversees 80% of food consumed and gets 20% of resources, USDA overlooks 20% but USDA gets 80% of allocated resources
-we need FDA to tell the agency what it needs –the FDA needs to help us, so that we can help the FDA
-once we get the facts, we can figure out what actions are needed
-we’re finding out that large part of inadequacies of funding of FDA and lack of the authority to carry out regulations
-the reality that the amount of food imported in US is double the amount it was 10 years ago, 25% of fruit is imported and 80% of seafood is imported
-experts believe import shipments will reach 300,000 this year
-the FDA hasn’t asked for more resources and ideas of how Congress can strengthen their authority - major failures of FDA is their inspections -FDA has failed to carry out their responsibility
-FDA hasn’t been forthcoming with their information- FDA has failed to get this Committee of info like closure of labs, safety of seafood
-in China, 1/5 of their own food has not passed food safety standards
-rivers in China are so contaminated that fish have to have antibiotics to stay alive
-while this is going on, FDA is proposing to close labs
-this country is supposed to have the best and strongest labs to protect our consumers
-more than 20% of seafood in US is imported from China-
-how is FDA proposing to fix? food czar with no real authority, reorganization of agency by closing labs — this will shift responsibility of ports
-FDA has regulated by having the food industry do itself — this needs to be changed
-we hope the FDA officials will acknowledge the glaring problems and correct the abuses that we have shown today
-safety and cleanliness of food must be protected
-we have visited numerous ports, talked to many staff - we focused on three areas: extent to which FDA is protecting food safety, FDA’s proposed reorganization and closing 13 of the 17 labs, extent to which FDA uses voluntary guidelines in food safety
-we examined leafy greens, protein, seafood, peanut butter
-confirmed the results of April hearing
-FDA has failed- legislation is needed
-the reorg. would exacerbate the system
-the guidelines are inadequate to protect food safety
-review of operations in SF: physically impossible for office to complete cursory reviews
-4 employees to review 4,000 entries
-they have to do 1 entry every 30 seconds - that is the time that they have to decide if someone should investigate something
-the FDA allows companies to test by private labs
-”detained”- this means allowed delivery to importer- the FDA allows them to use private labs- FDA has no authority to audit or check the reliability of the labs
-if negative findings in 5 shipments, then that exporter is removed to import alert -then future shipments from that exporter will be able to come without any kind of investigation or alert
-20% of seafood exports coming into SF were found to be disguising as decomposed fish
Stupak: you had a chance to visit San Juan, Puerto Rico lab? Did you see any counterfeit toothpaste?
A: Yes, we did.
Stupak: this toothpaste contained diethylene glycol
Stupak: did you see toothpaste and toothbrush combos?
A: yes, SF put an alert on the toothpaste. then the importers were putting the combo of toothpaste and toothbrush and were called toothbrush instead of toothpaste, so those products avoided the FDA alert- then the office in Puerto Rico realized the fraud, and now that has been stopped
- they were found in dollar stores
Stupak: FDA import alerts- can you talk more about them? first on wheat gluten and then on seafood? the word “detention” does that mean FDA detains the product?
A: No, FDA allows the product to be shipped to the importer and then they test the private lab.
Q: is there any way that a firm can not have to test private lab?
A: if the company has had 5 negative results, then they are not subjected to have their product tested
Q: which labs did you visit?
A: SF, Denver, Winchester, North East lab in NY –
Q:did you talk to analysts about private lab?
A: they are very critical- said labs were spooky and not good -
Q: does FDA credit these labs?
so these private labs are free of accreditation and have no credibility with the FDA
Q: Colgate toothpaste coming from China?
A: the country of origin is listed as South Africa. Colgate says that they do not produce in South Africa that size of tube and it is suspected that it comes from China
Q: so it’s not proven that it’s from China
A: yes. but there have been other tainted toothpaste coming from China
it’s antifreeze that was being used in toothpaste
Q: center for nutrition has known about carbon monoxide in fish and that they have known about it for years
A: the SF lab has found that 20% of fish imported has been decomposed and carbon monoxide has been used to hide that decomposition - 9 entries came in and were rejected by NY lab for decomposition
in 2001, FDA has approved the used of carbon monoxide for retail sales of tuna
Q: why would they do that?
A: I have no idea
they have said that it’s been safe for fish since 2001 and meat since 2004
Q:what would you say the 3/4 most important recs?
A: stop reorganization of the FDA that they are proposing - no justification of this reorg. - it would cost more than it would save
Q: you say that investigators advised committee staff that mandatory protocols are necessary and things won’t change until there are those mandatory requirements
A: yes, that was the unanimous opinion - about 20 people said that voluntary guidelines would have no real impact- the industry itself would prefer mandatory guidelines- the state inspectors also agree that there should be mandatory guidelines
Q: yes, Congress should mandate these- and the FDA should move forward to have mandatory protocols- Congress will have to act if FDA won’t
A: FDA had gone to the Dept of Human and Health services to propose of mandatory protocol and Dept of HHS refused
Q: this is regrettably that the agency will not act - splitting up the compliance function- impressed with individual inspectors. how will it work with separate decision of compliance and then send that decision to somewhere else across the country. it seems unmanageable.
A: yes, we think so. SF invest will report to a Seattle office. right now, invests when they decide- they don’t determine that recommendation - they sent that to a compliance office- and if that inspection fits within the work plan, then it will be inspected- if it’s out of the work plan, it takes a lot for it to be inspected
local officials have the experience with local trade
Q: district labs and attentiveness of the staff to the issues? are they taking the initiative for their own criteria? or are they waiting for Washington? readjusting workload of increase of imports?
A: lots of frustration even among labs that are not proposed to be closed
- a lot of the methods are determined by individ. labs but some come from Washington - the workplans for the labs are dictated in Washington- they aren’t able to determine which samples they can analyze. their performance is rated on how close their workplan fits what is given to them from Washington
Q: the bureaucracy doesn’t give them the flexibility to change and turn things on a dime?
A: well, the bureaucracy can tell them to turn on a dime- the direction is entirely from Washington
Q: primarily the products are from China and they are being produced for a specific chain of dollar stores?
A: I don’t know that answer
Q: are we looking for products coming from certain provinces of China? are they red flagging certain products?
A: depends on product and district
Q: we need more flexibility to district offices so they can make more determinations within that certain idea
Q: response of the FDA answering your questions?
A: documentation is usually incomplete- what is missing is not identified
interviews with the field staff have been very cooperative and candid
Q: so there is a disconnect with the staff of what they want to do? they don’t have the authority to do it
labs- what % are they testing
A: under 1% labs testing - the lab system is divided by task
Puerto Rico, Philadelphia are drug labs
Denver, Atlanta, KC are food labs — KC is doing food analysis from food coming from Mexico
LA, NY- they do both
specialization in labs
Q: but they don’t have flexibility
A: the National workplan designates the number of samples for each lab - Washington determines what needs to be sampled
Q: Oasis system: only 20% of food imports appear in the computer system called Oasis system - that are being sampled for tests
A: there is a huge categories of foods that are not even in the computer - you find stuff that is not being review at all- wheat gluten wasn’t in the system, so it wasn’t being tested-
Q: clearly the system is designed for a world 50-60 years ago. is there any ambiguity of who is in charge? do all of the agencies mesh seamlessly in this process?
A: most of the time. their respons is distinct. they all rely on Customs Border and Patrol to enforce the enforcement actions, denial of entry
Q: i asked a vet about the pet food problem - i didn’t appreciate how severe the problem was before. The vet said that it was significantly more widespread and probably involved brands that were not recalled. he did see a spike in unassociated kidney illnesses.
do we have to get wheat gluten from China? why don’t we stop import of wheat gluten from China?
A: we do have other countries that make wheat gluten. i can’t answer the question of stopping import. FDA did a lot of testing and they found very little other batches of wheat gluten or protein that contained melamine. The animal feed come from the discards of the pet food companies that had imported the melamine laced pet food- reports from China say that it is more of a widespread problem
Q: it seems that it is much more widespread than it is reported
Q: the FDA employees supported mandatory guidelines? what kind of?
A: they are voluntary guidelines that the industry follows- even in the testing protocols, there are no guidelines
FDA invests say that the real problem with spinach was most likely water - they say what would solve the problem is mandating that the fields that supply vegs that are not cooked
Q: mandating testing protocols and certain practices. did the FDA show any documentation of what their cost analysis of the reorganization
A: the FDA has assumptions and undocumented assertions of costs- there is no supportive documentation
Q: any documentation of impact of closing Denver lab
A: they haven’t given anything to us. they are still giving info to us. they gave documentation to us even yesterday. there is no analysis in the documentation
Q: did they give reasons why not giving them?
A: not formally
Q: the Denver lab does a # of things and has respons for animal and food research - Denver lab is the only lab that has a section that tests animal feed and milk for antibiotics - they developed protocol for testing melamine effective.
A: yes, they were very efficient
Q: did you get a sense that was antiquated? problem with morale?
A: No, it was not antiquated. staff at all labs were low especially the ones that would be closing. only 2 of the employees from the lab would be transferring.
Q: so, we would be losing all of that experience.
Q: what is the problem with these private labs?
A: the FDA does not inspect the labs- complaints: improper methods, shoddy work that was sent to FDA, they believe there were labs that importers knew the results were not going to be positive on their shipments
FDA had no power to not accept those lab results- all they could do is take an invest to take a sample and often, the results were different
one example is fish: swordfish and tunafish - the larger the fish, the higher the toxin level — if they have shown five results of negative findings, then they can be removed from the alert.
they ship in the first five samples of small fish that haven’;t accumulated the toxins and then once they are off the import alert, they don’t have to worry about the size of the fish
-they know which ports to go to, and which labs to go to
-with private labs, the bottom line is money
-spoke to owner of one private lab, his lab is good and that he can point out that numerous private labs can guarantee good results.
-the importer pays the private labs
Q: these are not labs that contract with FDA? FDA just accepts the results. the FDA doesn’t inspect the labs, but they accept documents from the labs? They have to?
A: I don’t know. It’s FDA policy.
Q: how many ports of entry that USDA checks product as opposed to FDA?
A: the USDA restricts to 10 ports and there is no restriction on FDA- there are 326 ports
Q: so, i could send my food through ports that I knew that were not testing - at any of these ports that have a physical facility, do they do any testing?
A: there are only 13 labs that are FDA labs. and they are proposing to reduce it to 6. They do have an arrangement with customs. There is no FDA presence in the Virgin islands, so customs’ task is to alert agency of any problems and then the FDA asks them to let the goods go through or to hold them up for sample
Q: is there some reason that crawfish wasn’t included?
A: i don’t know. That’s a question for the FDA. The SF office said that there was a lot of problems with seafood imported from Vietnam.
Q: i’ve heard that foreign countries can put their ingredients in other manuf containers and send them through.
A: I don’t know that answer. We didn’t ask those answers.
Q: How is alcohol handled coming into the country? Any validation?
A: different agency- that wasn’t part of the inquiry
Q: i ask this because we don’t have any problem with alcohol but we have problem with food that we survive on.
Q: you visited CBP in Oakland- why did you go there?
A: they had pulled shipments of wheat gluten- we were going to watch them take samples from the bags.
Q: were you looking for Chinese wheat gluten? but if they don’t have the origin of country on there, how do you know it is from China?
A: we were able to look at the entry documents
Q: There were no markings on there but you are sure it’s from China.
Q: now, some firms go through to a port in Las Vegas instead of SF?
A: yes, the expertise is very good in SF, so they go to Las Vegas instead.
SF, Seattle, LA gets the imports from the Far East. They have an average of 30 seconds to look at a computer screen to decide if the inspection of that entry or not.
Q: the guidelines of how to handle inspections- voluntary guidelines- they go for any country?
any FDA inspectors in other countries that ship food?
A: at low acid canned food plants
Q: Menu Foods testing?
A: they were turned over to university labs- none of the labs were allowed like the Kansas City labs were allowed to test samples
instead they contracted to university labs-
Q: 326 ports- how many inspectors
A: about 1/4
Q: so about 25% of ports have inspectors at them
Q: did you go to the port that they send fish in Los Angeles and did you talk to anyone there?
A: no, we didn’t talk to anyone there.
Q: in LA, they have a risk based analysis of the imports instead of just putting in economic data. we’re dealing with a system that was set up after the second world war. we either need to close the borders or be creative in our approaches. did you get any sense of how to fix these problems?
A: we have not done the extensive investigation
Q: that is one of the most critical things ahead of us. The FDA doesn’t collect user fees and perhaps that’s something they should consider. we need to capture the innovation and technology that is out there.
Q: the staff reports said that a lack of aggressiveness had something to do with the peanut butter contamination. The FDA didn’t obtain the microbial testing because they didn’t request through a written request. Then the FDA didn’t issue a written request.
A: the witness that said that microbial tests showed that there was salmonella in peanut butter since Oct 2004. these companies know that FDA won’t ask for documents in writing. the manuf can’t be held criminally liable for not sending in test if there is no written request. It’s amazing to me that the company had found a toxin in their product and refused to give you the results, and the FDA wouldn’t write a request
Q: is there some rationale.
A: it’s not policy. one witness said it has happened once in his 33 years of experience. At the district level, they would have to write a request. This is something simple that the agency could correct today.
The inspectors don’t have any liability. The act says that they can’t have any criminal action on those documents.
It’s nonsensical that the records weren’t being written for.
Q: if they were written for, would the records would have provided?
A: there is nothing in the law for them to provide those records.
Q: country of origin labeling? How can we protect ourselves if the country of origin is not accurate?
A: it’s my understanding that no one has to label country of origin. we don’t label them in regard to country of origin.
Q: was it chance that we found the windmill product came from China?
A: what customs told us was that the importer of the wheat gluten had to tell the person that he was going to sell it to was to tell him that it is from China. customs say that they on their own initiative that they could require the bag to be marked that it is from China. the consumers are also not notified where the ingredients are coming from too.
Q: the CBP did act on their own initiative but there was not coordination with the FDA. please explain in detail of how they don’t work together
A: in almost case, customs deters to the FDA to what is coming in the country since FDA is responsible. For some reason, customs took their own initiative to test the wheat gluten. FDA had not been notified what customs was doing, but after 2-3 days, it was coordinated. It was a rate event that customs would act without FDA’s request. When customs detain it, they detain it in the control.
Q: do we have idea of the total budget, employees just for testing imports?
A: we have that data but I don’t have it.
Q: we became a net importer of food products now. when you analyze the reasons for FDA looking at closures, it is just dollars and budget cuts?
A: don’t think it’s dollars- it’s centralization of power into Washington and regional centers instead of districts. plan to take local control over invest and put it in 6 regional offices, so inspectors in the fields will be reactive to instructions in offices far away. the inspectors will be simply soldiers. no lines of input in the information. it’s consolidation of policy- so the policy that is established is the sole source of activity in the field. this will be taking away the source of information from the agency.
Q: when i look at the trade agreements - is there any logic that there isn’t a country of origin labeling
A: your question is beyond our investigation.
Q: do you have specific recommendations that we should be looking at?
A: invest is preliminary
the CDC, 76 million Americans get sick and 5,000 die from food hazards. 10% of American diet is from imported products.
over 80% of consumers believe that made in china equates to may be contaminated.
-USDA uses very different tools than FDA- countries must go through 2 reviews, on site reviews, upon arrival at the port, it has to be approved before it comes in the US- every lot is inspected- also random sampling is done
15% of imports are physically tested by USDA
FDA doesn’t evaluate national programs or visit other countries to inform of standards. FDA relies on border inspections. FDA can’t rely on other countries for the safety of our food.
China has become the third largest supplier of food to the US.
The US food safety laws are over 100 years old and are not fit to prevent against bio terrorism, and increasing imports.
served at FDA for 27 years
-we’re at a critical point and we need to make certain decisions
-there are flood of imports, threats to food, and weakening FDA
-a hollowing out of the FDA program
-trade from these countries is a reality
- the consumers need to rely on the FDA– but when there are only 450 inspectors to inspect these imports
-the agency has lost a 1,000 people over the last decade and most of that has come from the food safety department.
-the strengthening of the FDA needs to become a priority- that agency needs help and you may be the only ones that can protect them
35 years with FDA, both field and HQ
- Feb 2006: reorganization information was provided - it was announced that district offices would go from 20 to 16, labs would be closed. we weren’t given any information of how they reached this decision
-there was a goal to have no districts with no more than 50 inspectors.
-communication was not done well on the reorganization
- we have received several emails and a website that gives broad goals of the reorganization - but these goals aren’t tied to any plans of this reorganization.
-we were told that reorg would reduce compliance branches from 20 to 10.
investigations develops any kind of evidence if they find a violation at firm. they write a report tying this together and submit it to compliance branch. compliance branch decides if they want to submit a decision to go further and send that to Washington.
if we don’t have compliance branch at some districts, and that means they would have to go to another district to see if they would take the case or not.
we see this plan is very inefficient- threaten relationships with states, interrupt long term ties with states, no clarification of manager roles, lines of authorities will be muddled. most of the decisions have had no basis for them. we are concerned that the plan is that we will go down to 10 districts.
this could affect our ability to protect food safety.
it would impossible to understand these implications from headquarters. it is about the daily decisions that are made in the field today.
hard time dealing with emergencies, more cases to review, more personnel issues- there could be a mass loss of institutional knowledge
the Denver district is dedicated to the agency. it has been operating with about 50% of the resources that is needed to do its goals. The employees have met or exceeded their goals.
during melamine emergency, we developed a scientific procedure to test melamine. within 72 hours, the melamine was validated and distributed internationally.
the Denver office is scheduled to merge with KC office in October. then the Denver district lab will be closed. the 50 employees will not be transferring and we will be losing this talent and there will be a brain drain in the agency.
it takes a min. of 3 years for an analyst to be trained.
the Denver lab is a go-to lab in the agency. we were the leader in the laboratory accreditation for all of other labs.
without the Denver lab, our food will be much less safe.
(20 minute recess)
We missed about 5 minutes of the hearing after the recess due to a computer glitch.
Panel II continued:
each year we analyze 1100 samples and this data is used by other scientists and organizations.
our program has been accredited by the WHO as the standard for other countries to model their programs.
the KC lab is a central location for the US and is home to an international railroad center. these centers are intended to unload and distribute ports for imports coming from San Diego and the West Coast. the largest Fedex center is about 10 minutes from the lab.
the lab was remodeled in 2001 and we are well equipped with up to date equipment- we are the 6th largest lab in ORA- we are a full chemistry lab, we are ISO 2000 accredited.
our microbial department tests 800-1,000 samples.
-we participate in foreign and domestic drug testing.
-40 years with FDA
-lab houses 2 specialties: toxic elements and food additives — the closing of our lab will lead to a loss of intelligence and experience
-group was instrumental in developing seafood grade analysis, and detecting lead in candy
(talks more in detail about the importance of the San Francisco laboratory)
worked for 16 years at Winchester Engineering and Analytical Center
-the closing of this lab will have an impact on ORA’s mission
(goes into detail about the importance of the Winchester Engineering and Analytical Center)
-only facility that can detect beta,alpha, and gamma contamination in food
-sole facility that provides info to the CDC, USDA and other government agencies
-we are confused because we have been praised for our commitment and knowledge, but then hire for other positions outside of the lab.
-we do not see any merit of closing the lab.
Q & A:
Stupak: why is India #2 for rejections in imports? (Mexico is #1 for rejections in imports)
A: they don’t have regulatory structures nationally.
Q: but if the quality is voluntary, then on what basis do you reject them?
A: if products are coming in with visible filth- some problems with salmonella in Indian spices - the best system would be where we had mandatory standards
Q: any reasons given why your labs were given to closed. You’re all silent, so no answers.
Kansas city lab was important in the wheat gluten case. what did you find in compar to university labs?
Adams: our labs are an hour and a half away from Emporia. when this first occurred, our invest went down there. we received a lot of samples and finished products. university labs should be following our some protocol.
Q: how many employees are willing to move?
Adams: the newer employees are more willing to move but these employees have less experience.
Q: is there an advantage to having a lab near to agr farms (Salinas Valley)?
Jacobs: yes, organisms are fragile and having a lab nearby is critical because the next day, the organisms doesn’t show what was on it before. Why else would be a great loss to this country of losing the lab?
A: we have a lot of people are analysts that also work as investigators and having someone near by with analytical expertise is critical.
Q: the USDA has plussed up for food safety and resources while FDA has been reduced. if it’s true that FDA is responsible for 80% of food and has 20% of resources, what is the rationale for that?
A: it’s the way that Congress set up the meat industry standards in the 1900s. if the meat inspectors aren’t there, then the plant can’t legally operate. the paradigm is that the USDA has to have money to have the inspectors there, so the plants can operate.
Q: do all of you agree that FDA doesn’t have sufficient money to inspect these food items?
Q: it’s scary of the amount of contaminated food that is coming from other countries - if we put this on a scale of 1 to 10, where would you put the FDA today in protecting the people?
A: we’re in the range of 1. FDA is not preventing problems. (DeWaal)
Heppe: 5 - because we don’t have enough resources but we try to do the best we can
Collins: 3 or 4, but if we lose the expertise then I would give it a -2.
Adams: 7 to the drugs and devices, 4 or 5 to the food
Jacobs: low number
Clavet: 2 or 3
Q: that doesn’t speak well and we have a lot of work to do
Q: Why is carbon monoxide used on fish?
A: used to brighten the reds of the hemoglobin - usually used on salmon
Q: Hubbard, you say that the body that the FDA is under is the problem
A: I won’t say the FDA is perfect by any means, but they don’t have the means to solve the problems. this is not a new problem. I hope Congress acts this time.
Q: do you think the FDA needs to articulate the problem? Or do you think it’s Congress and the bipartisan?
A: money has shifted out out of FDA due to other problems- - unless we don’t build it up, these other ideas that we have won’t be any good.
Q: in th 1990s, there was a big push to solve this problem. what happened?
A: fda took the lead in seafood and then juice. USDA followed FDA’s lead with meat. Meat is safer now. Where are the scientists think they fixes are and where can they get them?
Q: Country of Origin labeling? You suspect the COOL isn’t necessarily effective.
A: I don’t think COOL doesn’t work. Wherever the country it comes from, it has to be safe. It’s difficult to trace things back to the countries. I don’t think labeling being as an answer. We need safe food.
Q: Hubbard - 13 million entries of imports a year - what % does this make of American food?
A: I think that a total of 15% imports make up total food supply.
Q: how many food illnesses are related to imported food?
A: no decent data- CDC can only account only 5% of illnesses due to imported food.
Q: do you think meat exports that we are shipping to China are a threat?
A: I don’t think so. I think our exports are very safe.
Q: I read that china is stopping our meat exports. do you think this is a retaliation?
A: that certainly is speculation. this trade issues get thorny.
Q: I support COOL. It does affect my purchases of where it is labeled. I think about what are the food safety requirements of that country. You all have said food supply is in peril.
A: the central government can’t reach to these small farmers. to try and regulate that, it is an enormous task.
Q: so whom should that task fall on? the FDA?
A: DeWaal- their food law is in the process of being modernized- what US consumers are looking for are to trust the safety of the food. we can’t rely on other governments. it has to be on a certification programs. or individual plants may be certified before exporting.
Q: other countries require us to label our country and document everything. why wouldn’t we do this to our imports?
how big does FDA have to be to be effective?
A: substantial increase in staff and scientists, and inspectors. it’s not just the #. it’s modern mandates. it’s going to require authorizing.
Q: it is strange to me that we are still using a method from 1906.
Q: do you think COOL is not appropriate for all products? How about bulk ingredients?
A: there should be COOL on bulk ingredients. with all of these ingredients, it is difficult to do that. nowadays, many products include ingredients from many countries in just one product.
Q: why does our country walk away from standards?
A: The currently law doesn’t allow FDA to go to other countries and here are the standards that you need to meet.
Q: is there some way to put the mandates on there, to have labs that are accredited or controlled by FDA?
A: certifying labs would be a good thing.
we have a different model on import inspection at USDA and that model may not be completely fit with the FDA, but it should be looked at.
Q: is there someone in the agency that can give us an objective viewpoint of what was good and bad? i think we need to constrain the # of ports.
Q: do you support inspection fees, Hubbard?
A: personally yes, I think if FDA can get more resources.
Q: you are saying if we give $10 mil to FDA, you say that they will give $9.5 mil to retention bonuses for employees in the pharm dept
A: the $10 mil will not be enough.
Q: what good will it be to give the FDA 10 mil if they give it away to another part of the FDA and for drug approval?
Stupak then states that Hubbard gave retention bonuses to employees during his term. He said that Hubbard’s logic was that the employees would leave if they didn’t get bonuses. The bonus was based on an average amount of lobbyist gets in Washington DC.
Hubbard said that he tried to induce employees to stay.
Q: you are not in support of COOL- COOL for meat, produce and peanuts has been blocked. Yet 92% of consumers want COOL. Don’t you think people have the right?
A: You are right, people want to have that right.
Q: COOL has worked with seafood.
A: that’s a whole food, so yes, it has worked with seafood.
Q: Hubbard, in 1999, the agency drafted a legislative authority to make other countries to take more responsibility. if there was some way to keep countries accountable, then maybe they would have an incentive to increase their standards.
A: the concept was a country that had no problems, we wouldn’t do anything additionally. for countries that had problems, they would be on an embargo until they proved that they had fixed their problems.
Q: you had mentioned of $131 million dollars for food safety research that would go to USDA
-that number is close to the president’s request.
A:The number for food inspection is $28 million. the food inspection program will get an increase of $14 million.
Q: is that adequate? would you see some of the money moved to the research to the inspectors?
A: Of course. But you will get push back from USDA.
He asks questions of Calvert of the Winchester facility and why it is important and examples of when they tested for radiological threats.
Q: what do we lose if the facility closes down?
A: you will lose the radiological component of the FDA.
Q: have they given a reason?
Q: it’s further weakens the FDA and I look forward to answers from the commissioner and why they want to shut down the Winchester lab.
asks about the Denver lab and what their facility does.
They developed the methodology to test melamine in animal tissue. We were able to do that within 72 hours after starting the project. We were able to figure what was in animal, fish tissue, so there was a method out there for our lab, state labs, private labs.
Q: How were you able to develop that within 72 hours?
A: the amount of expertise and the time that was devoted to these processes.
Q: how many employees are at the denver lab?
A: 47 or 48. 3 are Phds.
the FDA came into existence 100 years ago because of critical problems in the nation’s food safety.
-the agency has had to adapt to challenges and to respond.
-this agency is recognized as the gold standard around the world.
-I’m not here to defend the FDA in the past but to continue how to develop FDA in the future.
-we have become accustomed to walk in a supermarket and buy fresh produce
-recent events have riveted our attention that our techniques have created unique health benefits but also risks.
-FDA has to have to respond these recent events
- how do we respond?
-we have to change and change is difficult and painful to implement
-we have appointed a food czar to create leadership to create agency wide that builds on the excellence that already exists- this will enable FDA to have quality assurance during the whole life cycle of food from farm to fork
-this includes prevention so that we eliminate problems and intervention strategies so that can preempt problems.
-this plan will address domestic and imported foods and we clearly must build on the quality and surveillance of the prevention
-modern and well equipped field force
-these are intended to increase and enhance our front line inspectors with modern tools and better communication tools
-modernize back up facilities.
-we recognize that we need to come up with a well developed strategy and that we need more resources, we have received resources in 2007 and approved for 2008 and working on 2009 imp plan and resource.
-we examine our legal authorities and we must use our current authorities more efficiently and with greater clarity
-we need to work with other agencies and their resources esp with food imports
-last May, we met with China counterparts to talk about the awareness of imports.
-FDA working with Department of HHS to work with a memo of understanding with China
- we are examining if we need authorities to enhance our ability to overlook our food supply- to be more effective with adapting o importing food, voluntary recall structure
-we are working hard at a comprehensive food safety plan
-we look forward to working with all of you and the staff
-we look forward to communicating more effectively.
- i have changed the policy to respond to documents quickly and efficiently.
I’ve created an agency task force to focus on the prep of these documents.
- procure additional resources from Dept of HHS
-We, at the FDA, will radically change.
Q & A:
Stupak: I’d suggest you go to China in August 17 with some of our investigators that are going there.
Stupak: Ms DeChette said that the FDA hasn’t sent some of the documents and we’re still looking for documents from the ConAgra situation.
A: I wasn’t aware that we hadn’t sent documents to Ms DeChette. I will look into that. It is my intent and committment that we be completely responsive to this committee and other committees in Congress. We have recognized that this is put a great strain on us and we are trying to change that.
One letter not answered is one letter too many. I will look into those incidences personally.
Q: there are 12 agencies– have you been coordinating with them?
A: we have been working with USDA. CDC with outbreaks. We have looked at various orgs.
Q: have you talked to these agencies about your reorganization plan?
A: we have worked with the Dept of Homeland and Security. with reorg proposal, I want to make it clear that it is intended to bring FDA’s lab infrastructure into the 21st century. I went into a lab with NY when i first started, to check seafood, someone goes to buy seafood and an expert smells it and that is not my view of the FDA in the 21st century.
Q: this is why we want to change legislation– and the FDA has fought us on this.
A: this is not to eliminate labs- this is to consolidate labs that are more effective and increase inspection force by giving them the modern tools of science.
Q: by closing these labs, how will you increase inspections?
A: for example, with this water, an inspector seizes a water and is sent to a lab and then there is a report. we have a modern tool of science and tech that we can deploy to inspectors in the field and they can do that rapidly and efficiently in the field.
Q: how many inspectors will you have?
A: we create state of the art, well staffed labs with modern robotic technologies.
Q: we have no info on your reorganizational plan– even though it was promised to us.
A: our plan is a proposal and is in process and being developed. there are parts that have become public. this hearing has given us insight. these plans will need to be further refined and developed. we can’t depend on the current lab system of today to carry out the goals of tomorrow.
Q: when you get your info, send this out to us and most importantly your employees. they deserve to know and wouldn’t appreciate being called back up labs.
Q: FDA warning letters- we haven’t received a response of how many companies have complied with FDA warning letters. can you look into that?
A: it is not our intention to hold information. in defense of what has happened, we are in an intensive period of time. we have been engaged in legislative changes. we want to shift resources
Q: any reasonable effort would be to prioritize to us of the committee
my policy questions are how to modernize the FDA for inspecting and overseeing the food imports. I listed four points of the FDA to consider: good manuf processes more avail internationally, help profile the foreign food agencies, have separate foreign agencies, issue a rule on import alert- can FDA detain shipments — please comment
A: we reorganize the importance of strength our availability to inspect imports. we are working on the important role in working with our counterparts in China. we want to build quality in on the outset.
Q: on the reorganization program - 3/4 months ago, you briefed me on it and I told you to brief Dingell and Stupak. Did you set up a meeting with them?
A: No, I haven’t had the personal opportunity to brief them on the proposal.
Q: is there a formal proposal or is this an internal document?
A: this is still an internal document and it is a proposal. there have been discussions. this is not a work force reduction plan. this is not used to save money. this is to enhance our ability to respond.
Q: the sooner that you formalize this proposal, then go ahead and let us know and your employees know. if it’s a coherent, well organized plan, then you can get the majority to go along with them.
A: yes, i agree. we are not closing labs to eliminate functionality. it is it consolidate our assets and enhance to get the maximum impact. this will require shifts of this network. In Denver, it’s not a factor that the lab is exceptional. but there are 3 phds, and that’s not critical mass to analyze what we need to do. how do we create the modern infrastructure? we’re also asking independent experts to look and view this and get their perspective as well.
Q: the FDA is reviewing certain levels of authority with food safety to see if they need more authority - I’ve been working on a bill for mandatory recall of all food. would that help or prevent some firms from selling contaminated food?
A: yes, i agree with you that the mandatory recall of the FDA authority and take care of the bad actors is good.
we’ve seen that voluntary procedures are working well. but if there are bad actors, we want to take care of them.
Q: if the fda had mandatory recall authority with the peter pan situation, it may have been taken care of faster.
A: possibly so
Q: these regional labs don’t all do the same thing. the Denver lab does something different than other labs.
Q: in modern era, people are working on remote locations - has the fda looked at those kind of alternatives?
A: I’d like to turn the microphone over with Ms Claven. Yes. we have looked at it. Certain proposals remain in place but report to different districts. with respect to labs, working at home is not an option.
Q: i’m not talking from home. I’m talking about if you have senior scientists, why wouldn’t you want to help them do their job?
A: I agree. This can be done with a variety of locations. We have labs in 13 locations and that makes it hard to have a coordinated approach and if we can bring people together to provide them with the tools and the resources they need.
Q: has the fda considered the balance of hope bringing people together with the deep loss of science that the FDA will suffer?
A: yes we have. would the 3 PhDs benefit being with other PhDs at other facilities? can we give them an infrastrucutre that will give them resources? we’re looking at all of them
Q: only 3 people that do that job. has anyone talked to them about what they will be doing?
A: we would want those people to move with us. if they don’t, we have to believe that there are 3 other people that can also do that position using modern tech. the USDA has only have 3 labs.
Q: there was actually a problem that identified before the problem with e.coli in spinach. somewhere along the line we didn’t follow through.
A: I can’t testify to that if that is a correct recollection.
Q: how we can make sure that products are safe? Are there other tools that you need from us?
A: in addressing this radical change in production and consumption of food - there is nothing made in America or china– it is more of assembled. we have to look at this in a comprehensive way. the FDA hasn’t emphasized prevention, so prevention is an extremely important part of the plan. we will work with the producers, so that we can assure that we are enhancing quality before it comes into our system.
we’ve learned that the impact of one tiny mistake can lead to a radical change and disastrous results. we have learned a lot about how produce can become contaminated. we are looking for devices to do the same thing with microbial contaminations. when you have a contamination in a concentrated area, it becomes more difficult.
Q: are you keyed into surveillance of food borne illness?
A: we have made an inter agency to link our ability to data sharing. the CDC is the first line of defense of a food borne illness. when it becomes an outbreak, then it is the FDA. we need to be more seamless to enhance our data systems.
Q: had you checked with the SF district office, they would tell you that in the last 10 years, there have been 10 outbreaks in the Salinas area. the investigators say that voluntary guidelines would not work.
A: let me be clear, a mandatory regulation and the guidance — there are areas that science is not mature enough to define a regulation that is mandatory all the time.
Q: you don’t think you have info at any time to have mandatory recall?
A: I’m not going to say that science isn’t there.
the science is going to have to decide what is the source of contamination - in the mean time, we will use guidances as science evolves.
Q: there is certainly a lack of confidence in the FDA. does the FDA need mandatory recall for our water?
A: water quality is looked as good agricultural practices
Q: does fda need congressional authority to have a mandatory recall when water is used in a product.
so you’re examining if you need that authority? and mandatory versus voluntary
A: it is currently a guidance.
Q: are you examining that in the future?
A: we are examining that in the food protection plan and our reassessment of the authorities is being examined.
Q: you looked annoyed when you didn’t answered a letter. there is a systematic holding of information. we have a respons too.
Q: we are confused that we put $10 mil in the FDA and you gave out 9.5 million in bonuses
A: our precious asset is our employees.
Q: then why didn’t you ask for it as employee retention and bonuses and not part of food safety.
A: the bonuses were applied from the local districts
Q: so you then you have to cut back from food safety to pay for bonuses. where are you getting the money?
A: that comes out of Dr. Brackett’s budget.
Q: we can’t find out where that $10 million went. We just have this bonus money. employees in your office collected 30% of top FDA’s cash awards in 04,05, 06 and office of regulatory affairs, they only collected 19% cash bonuses yet that have 35% of FDA’s employees.
Your office went up by 80% in cash awards, while the office of regulatory affair only went up by 30%. As imports have increased, the cash award for field employees have gone down while the employees in your office went up.
A: I need to look at those details. We are committed to looking at bonuses so the criteria are looked across the agency. There is a $ in the center that is used for bonuses in that center.
Q: inspector of the year received a $1,000 bonus and while management team gets 20 times more than the inspector. how is that fair?
i think your mike went off.
A: there are performance and retention bonuses.
Q: get us the information, so we can figure out where the money went. we won’t be asking questions, if we had the info.
A: we will get you the information
Q: damned if you do and damned if you don’t
Q: does USDA give bonuses?
A: I assume.
Q: don’t assume.
USDA requires certification that other countries have similar safety standards to us. do you support a similar certification under FDA’s jurisdiction of training other countries?
A: I support working with foreign sources to enhance their abilities
Q; so, the answer is now.
A: a this point, I don’t have t hat info that it should be mandatory across the board.
Q: USDA has only 10 ports while you have 326-361 ports. would you be in favor of bringing it down to the the 91 ports that you have inspectors at?
A: I can’t answer that. I could not be in favor because I don’t have an analysis of what that would imply/.
Q: should that be in part of your plan?
A: not in the favor of having other countries going to other ports
Q: how else can you inspect them?
A: using modern tech
Q: how can you do that when you only have 91 ports
Q: will you not close these labs until Congress approves it?
A: I will.
Q: Well, you say that you will, but that doesn’t mean anything
Q: I bet you will get your reorganization done before we request it.
Q: how will the FDA handle the reduction
A: this is not intended to reduce FTE’s- there may be a shift from someone who is a technician to someone who is a field deployed invest. this is not a work force reduction plan. this is a redeployment plan. modernization and consolidation.
Q: so going forward, can I ask you that you keep the committee updated?
A: we are not going to experience a loss of functionality. the other thing is that the people that have testified earlier are FDA’s finest and they are working hard.
Q: would you be in favor of keeping countries accountable for what they send to us?
A: we are exploring that so that we have much better security, if we can’t keep the quality of the ingredients.
we’re also working in close coordination with Dept of HHS and counterparts of the other agencies.
End of hearing