Full details after the jump. We’re still working on finishing the notes.
Intro by Mr. Stupik (MI)
- it appears that FDA has cut back on field inspections and that industries will self regulate
-food borne illnesses show serious flaws in our govt.
-imported food from China does not have to comply with health and safety standards
-food safety is a national threat
-food poisoning will happen to you, your children and your pets-we should be expecting more from our govt.
Mr. Whitfield (KY)
-in 1970s, food safety took up one half of the money of the FDA and now it takes 1/4-all of us are very concerned with increased imports for our food supply
Ms DeGette (CO)
-we take for granted that our nation and the industries are acting in the consumer’s best interest-we need real reform for our food safety laws- some people may say that these are isolated incidents but it is a systemic problem and it calls for systemic solutions
-we need a mandatory recall bill
-we need to reform the system before there is an outbreak-the FDA has become more relient on the industry to regulate themselves- but the problem is getting worse and not better
Mr. Waxman (CA)
-we are at a critical moment for food safety- our system is broken
-our food supply is vulnerable to attack
-5,000 people die each year from food borne illnesses
- 3 problems with FDA: inadequate resources, standards and enforcements — 24% budget cut which has led to decrease in inspections
-FDA must set clear and precise standards
-FDA must enforce its own standards
Mr. Green (TX)
-76 million people are affected by food borne illnesses each year
-the FDA has known about our food contamination for years
-our food supply gets short shifted at the FDA
Mr. Barton (TX)
-the reluctance of the Chinese govt to cooperate with the FDA is unacceptable and they are building a “great wall of bureaucracy”
-my message to the Chinese govt is to stop these shenanigans and cooperate
Ms Schakowsky (IL)
-want to consolidate all of the food safety committees
-hold food conglomerates responsible now
Mr. Burgess (TX)
-what was done with the pet food is not only wrong but it is criminal
-this practice must be stopped
Mr. Dingell (MI)
-our pet food was contaminated deliberately for profit
Ms Blackburn (TN)
-is the FDA too large and too bureaucratic to respond
-have they chosen not to shift their priorities?
Mr Inslee (WA)
1) we have to have standards that are binding — the word “should” does not mean that is required
2) we have to establish hazard points of identification protocols
3) we have to treat ecoli and salmonella as adulterants
4) we have to have mandatory recall authority
Mr. Murphy (PA)
- we need to improve the system and make it more efficient and really stand up for the safety of the public
1)Michael and Elizabeth Armstrong
Daughters: Ashley (2) and Isabella (5) Armstrong- both affected by e. coli
– the girls got sick by eating contaminated spinach; Ashley will most likely will have to have a kidney transplant
– Michael Armstrong said that I can’t save my daughters from spinach but You Can (pointing to the House of Rep Members)
2) Terri Marshall- mother in law was affected with contaminated Peter Pan peanut butter that had salmonella
- it took over a week for them to know that it was the peanut butter that was making the mother-in-law sick- it took 9-10 days for someone to contact them and let them know that the peanut butter had salmonella
3) Gary Pruden with son, Sean Pruden- affected by lettuce that had e.coli from Taco Bell — Sean has recovered
Q&A/ Misc Comments:
Schakowksy: ConAgra has instructed employees to only answer questions if asked and not up offer up any info. They say that FDA inspectors are NOT entitled to the following and if they are insisting, then they should refer to their regional office (quality control records, consumer complaint, manufacturing records)
Blackburn: this shows that there is a lack of process to inform consumer
1) Ms Lisa Shames- Acting Director, Natural Resources and Environment, US Govt Accountability Office
-while the food supply is generally considered to be safe, but with this incidences, this underscores our safety of our food
-focus on two points:
1) GOA rank on food safety- ineffective coordination, and inadequate resources- 15 agencies have over 30 laws in re to food safety
-FDA is responsible for regulating over 80% of companies but receives only 20% of food inspection resources; USDA does 20% of inspections but receives 80% of the resources
-recommended comprehensive reformation, reconvened committee for food safety
2) food recalls are voluntary now and FDA does not have the authority to have mandatory recalls (except for infant formula)
- Congress enact legislation to alert FDA or USDA that they have manufactured unsafe food
-this underscores the need to transform the food oversight- brings needed attention to the fragmented system
2) Dr. Anthony DeCarlo - Red Bank Veterinary Hospital
-April 5, Congressman Palone visited the Red Bank Hospital and is now trying to expedite the govt’s response to these situations
-what we need is a better mechanism to track and get better info, and consolidate info
-there are many sites that vets get info from- the Vet community does not have readily available resources to get this info in a focused and timely manner
-many vets were alerted first on TV instead of by colleagues or associations
-possible solution using a central agency to get info from sentitental animal hospitals- they would report on a regular basis- the agency would report to the hospitals on how to deal with the results
Stupik: Is there any good way to get an estimate of pet deaths and illnesses?
DeCarlo: it is hard to get an accurate number- numbers vary across diff orgs. — percentages are all over the place- we are a small assoc- and who reports where makes #s differ– we need an organized and focused place, so we can have accurate facts
Stupik: so you can’t give us an estimate of numbers
DeCarlo: I think the # is more than 1600 that was affected- the fatality rates from some places are very low and others are very high-
Stupik: have you seen any melamine poisoning in cats or dogs?
Stupik: How do you determine food safety?
Shames: based on the numbers that CDC reports, any death or hospitalization is one too many- for the most part, we have a safe system.
- the problem becomes more complex as we become more globalized
Stupik: the FDA has no authority to recall any product except for infant formula- is this not a safety concern?
Shames: for the most part, companies do cooperate but the FDA has had to exercise their recall authority — within 24 hours, a company needs to inform their food is unsafe
Whitfield: What is a diff btwn a high risk and a non high risk report?
Shames: high risk series has evolved over the years and involved fraud, waste and abuse– food safety did merit a high risk destination- there are close to 30 high risk issues- we consider it to be one of the most top priority
Whitfield: there are mandatory recalls for toys and other things- what are the arguments against mandatory recalls for the food?
Shames: they can detain those products up to 20 days and after that, there must be a court injunction. if companies don’t voluntary recall, then it is up to the company to recall
Whitfield: the FDA makes the regulations and the USDA enforces the regulations- and the USDA doesn’t have good mechanisms to determine substances in food- if a hog digests melamine, is that something that we should be concerned with?
DeCarlo: the multiple agencies make it confusing on the info- we need a system that gets you the info quickly- the less agencies involved will make the process more effective, simplicity is good
DeGette: if you had mandatory recalls, then companies would be more forthcoming?
Shames: yes, this is how the other agencies feel
DeGette: is there some more efficient way to report and publicize recalls or outbreaks
Shames: it’s worth asking the FDA- what the FDA has posted- consumer groups have said that it could be more effective and wanted more specificity- the FDA has heard and has followed through this specification
DeGette: are they doing anything with targeting the outbreak?
Shames: they post it up on the website- the FDA says that they don’t have authority to pinpoint where it was sold
Walden: was there not an outbreak on melons awhile ago where human waste was being used as a fertilizer?
Shames: i’m not familiar with that incident.
Walden: can you wash spinach to get rid of the e.coli pathogen
Shames: good question- I can’t tell you how many times the food would need to be washed
Walden: take a look at importing foods- if you can write about the process of importing foods. Last year, I took a tour of Banfield Hospital and saw their new facility and saw their new computer storage and they track everything that comes in and the symptoms- so there are some databases that are available- will these type of databases help
DeCarlo: yes, but the databases need to come from several areas- some areas over diagnose and some under diagnose- you have to deal with volume and you have to look at locations as well- hospitals need to have adequate staffing and sufficient IT
Walden: some diseases that pop up on animals can also show up in humans like the bird flu
DeCarlo: Yes, this model is not new. We have to choose the right place to send all this info to and predict what will happen next. the info highway needs to be simple
Walden: we need to have a vigilant process
Inslee: Suggestion that this was actually in wheat gluten that is food grade. By luck was not in human consumption.
Shames: It needs to be address in a system wide basis.
Inslee: It’s never made sense to me (that food cannot be mandatorily recalled). Did anyone refuse a recall?
Shames: FDA or USDA did not say there was such a case.
Inslee: Has there been a pattern of foot-dragging?
Shames: Mandatory recalls have been used as a tool by other agencies.
Inslee: Did the FDA or USDA want this power?
Shames: No request from them.
Blackburn: Do you think they should have the power to mandate recalls?
Shames: We have recommended that for both FDA and USDA
Blackburn: Medical community is not accessing this info. Even the CDC. There seems to be lack of communication. Not only do we have 2 tiered problem with FDA and USDA, the problem also exists in the medical and consumer community. What would be the best practices for agencies in streamlining the approach to make food supply safer as well as the medical community and the public notification system. The first panel said there was no orderly process for reporting or discovery. (Asks for rec.)
Shames: No recommendations right now. We will look into it. We can learn form other countries’ experiences.
Blackburn: Are we safer than or as safe as other countries? Has the incidents increased or decreased over the years?
Shames: CDC is looking at the data. We will be looking to see how complete the reporting system is.
Blackburn: Would mandatory recall made a difference in the peanut butter or spinach recall?
Shames: We don’t know. Using voluntary recall, often times the food had expired on the shelf.
Inslee: In the case of the peanut butter recall, when the continued to feed the patients the product, that one does bother me. If the recall was issued in Jan, that process may have been stopped.
Shames: We did look at the some FDA recalls, canned soup. The longer shelf life made the recall more complete. The fresher the more problematic.
Insless: Wouldn’t a recall help doctors and with kids who think it’s just an illness? Getting data to the doctors?
Stupak: It’s amazing talking to the first panel that they learned it from the news media. Or it was a nurse who said check for brown urine.
1) Mr. Paul Henderson- CEO of Menu Foods (has his attorney with him)
I am Paul Henderson, CEO of Menu Foods Income Fund. The Subcommittee invited me today to discuss issues of food security and in particular the recent terrible situation involving pet food manufactured with contaminated Chinese wheat gluten supplied by ChemNutra Inc. to several pet food manufacturers, including Menu Foods. Let me begin by noting that I am a pet owner, and many of our employees are pet owners. My dog eats food manufactured by Menu Foods. I understand, and our employees understand, the loss felt by pet owners as a result of pet food made with contaminated ingredients. We deeply sympathize with these pet owners. However, we cannot turn back the clock, so now we must analyze what happened and how it happened and consider the steps that the pet food industry and government agencies should take to try to prevent things like this from happening in the future. Much has been said and written about these recent events, and a lot of it has been inaccurate. I appreciate the invitation to appear before the Subcommittee today to explain what actually occurred and to share my thoughts on the future of food safety in the pet food industry.
Menu Foods is the leading North American private-label/contract manufacturer of wet pet food products sold by supermarket retailers, mass merchandisers, pet specialty retailers and other retail and wholesale outlets. Menu Foods was formed in 1971 and went public in 2002, trading on the Toronto Stock Exchange. Menu Foods was founded in Canada, but our U.S. operations are much larger than our Canadian operations. We have three manufacturing plants in the United States, which are located in Emporia, Kansas; Pennsauken, New Jersey and North Sioux City, South Dakota. Menu Foods employs more 700 workers in the United States, and the majority of our sales are in this country.
Menu is recognized in our industry as a quality leader. We are known as the manufacturer of choice in the private-label pet food industry by retailers that value quality in their products. In over 35 years of business, Menu had never had a food safety-related product recall until the recent tragic events involving the contaminated wheat gluten. Menu produced over 1.1 billion containers of pet food last year, so this is quite a record, and we were very proud of it. We hope we can restore our reputation, and we are working hard to do so. Wheat gluten has been in short supply, and in 2006 we decided we needed to add an additional source for this important ingredient. In November 2006, Menu Foods bought wheat gluten from ChemNutra for the first time. ChemNutra is a U.S. company, based in Las Vegas, that is an established supplier of ingredients to food, feed and pharma companies throughout the country. Although this was our first purchase of wheat gluten from ChemNutra, we had purchased other
ingredients from ChemNutra in the past. As part of our program to ensure high-quality ingredients, Menu Foods provided ChemNutra
with a Material Specification stating Menu Foodâ€™s requirements for wheat gluten. The Material Specification provided detailed instructions and requirements, including but not limited to: material source, material description, physical requirements, chemical requirements, rejection criteria, packaging/shipping/storage requirements, microbiological standards, grind/particle size
standards, water storage standards, ingredient manufacturing requirements, labeling requirements, and key performance/functionality requirements. The Material Specification expressly prohibited foreign material contamination. Each shipment of wheat gluten Menu
Foods received from ChemNutra was accompanied by a Certificate of Analysis representing that the wheat gluten complied with Menu Foodsâ€™ Material Specification. Our Material Specifications adhere to the standards of the Codex Alimentarius, which is a
collection of internationally recognized standards for food developed under the aegis of the United Nations Food and Agriculture Organization and World Health Organization. There is no FDA standard for human grade wheat gluten, but Menu intends that all wheat gluten we use should be suitable for use in human foods. ChemNutra promised Menu Foods that it could deliver high-quality wheat gluten that satisfied the requirements set forth in the Material Specification. Menu Foods relied on ChemNutraâ€™s promises. Unfortunately, we now know that ChemNutra provided Menu Foods and other pet food manufacturers with a product that was contaminated with melamine. Needless to say, following this incident, we no longer do business with ChemNutra. A lot of speculation has taken place concerning Menu Foodsâ€™ activities leading up to the recall.
Statements have been made in the media and in public forums and even by some of the participants in the supply chain of the contaminated wheat gluten. Much of the speculation and some of these statements have been inaccurate. Some people have suggested that Menu acted too slowly and should have contacted the FDA sooner. On the contrary, we acted quickly and took appropriate steps under the circumstances.
Let me put this situation in context. Menu produces over 1.1 billion containers of pet food each year â€“ nearly 100 million containers each month. As of March 15, 2007, Menu had directly received six reports from consumers of possible problems with its pet food â€“ many of which appeared to be something other than pet food, in several cases confirmed by opinions of the animalsâ€™ veterinarians. One of Menuâ€™s customers, Iams, had received, and eventually passed on to Menu, three complaints involving animal health issues. Both Menu and Iams had received complaints of a refusal to eat the food, which often happens when an owner changes to a
different food or for other reasons completely unrelated to food quality. And the taste testing facility reported several deaths and illnesses, but nothing that indicated it was caused by Menuâ€™s food. Menu had conducted tests for all industry-recognized causes of problems with pet food, and these tests revealed no problems. In fact, it took the FDA, prestigious research organizations
and several commercial laboratories many more days to identify melamine in ChemNutra wheat gluten as the source of the problem. Based on this information, any pet food manufacturer could well have decided to continue to try to find the problem, but not to contact the FDA or begin a product recall. Indeed, based on what was known at the time, there might well have turned out to be no problem with the food, and announcing a recall could have only resulted in an unnecessary panic among pet owners. And,
the only indication we had of any issues with dog food was only hours old and as yet completely uninvestigated. However, Menu placed the interests of pets and pet owners first, so, like our good customer Iams, we decided that, notwithstanding the lack of scientific evidence, we should notify the FDA and begin a voluntary, precautionary recall.
Menu Foods is no longer purchasing any ingredients from ChemNutra and has taken steps to assure that none of the products that contain wheat gluten from ChemNutra are sold. The FDA is blocking all imports of wheat gluten from Xuzhou Anying.
Menuâ€™s investigation has revealed a possible motive for the presence of melamine in ChemNutraâ€™s wheat gluten. Menu Foodsâ€™ Material Specification for wheat gluten contains a chemical requirement that the wheat gluten contain no less than 75% protein. This is a typical specification for wheat gluten for both human and animal food. In the human food and pet food industry, protein levels are customarily estimated by determining the quantity of nitrogen in a product. Melamine has a high concentration of nitrogen and, as a result, the inclusion of melamine into the wheat gluten would make substandard wheat gluten appear to meet industry standards for protein content.
The foundation of Menuâ€™s business is providing quality, nutritious food for pets. We have been doing so for over 35 years. The safety of our products and the confidence of pet owners and our customers are our highest priorities. Menu Foods monitors for spoilage and has thorough quality control procedures. As is common in industry practice, Menu Foods tests the wheat gluten it uses for vomitoxin caused by mold growth. This mold toxin is the only contaminant in recent history that has been associated with a pet food recall involving wheat used in dry pet food. Menu tests every load of wheat gluten it receives for vomitoxin using an approved test performed by trained personnel. Menu Foods did not detect melamine during its quality assurance testing because accepted screening procedures do not detect melamine. Melamine is not something that had ever been heard of before in connection with wheat gluten. To our knowledge, no pet food or human food manufacturer tested wheat gluten for melamine prior to this incident. Some people have noted that Menuâ€™s Emporia plant had not been inspected by the FDA. That is true, but not surprising given Menuâ€™s excellent performance record and reputation and the FDAâ€™s limited resources. However, additional plant inspections would not have prevented the problem in this instance — contaminated wheat gluten purchased from ChemNutra. Moreover, Menuâ€™s plants are subject to significant internal and external inspection and review. Menu has its own quality control systems, which have been reviewed and approved by our customers, including global companies with substantial experience in quality control. In addition to Menuâ€™s internal systems, all of our facilities are routinely audited by outside experts. Menu engages the American Institute of Baking to audit food safety and sanitation. These inspections are conducted at least annually, and Menu has consistently scored in the â€œexcellentâ€ andâ€œsuperiorâ€ range. Menu Foodsâ€™ United States plants are inspected annually by the United States Department of Agriculture Animal and Plant Health Inspection Service (APHIS). Menu Foodsâ€™ plant in Canada is inspected annually by the Canadian equivalent to APHIS, the Canadian Food Inspection Agency (CFIA). Menu Foods is also inspected by the European Food Safety Inspection Service, which is widely respected for HACCP (Hazard Analysis and Critical Control Point) and food safety concerns. Menuâ€™s Pennsauken plant has been inspected by the FDA.
Finally, Menu is inspected by multiple global pet food producers with known high quality standards as a condition of manufacturing pet food for them. To ensure that we are producing the highest quality products, we have taken the following
additional steps in response to the situation:
â€¢ First, like other pet food manufacturers, we have stopped purchasing wheat gluten from ChemNutra. In fact, we have stopped buying any ingredient from ChemNutra.
â€¢ We now test wheat gluten for melamine. Consistent with our desire for continuous quality improvement, we have extended melamine testing to rice protein and corn gluten meal.
â€¢ We will conduct additional tests of wheat gluten and other ingredients in the future to make it more difficult for a supplier to sell us substandard product.
â€¢ We will implement more rigorous testing and supervision for new suppliers.
â€¢ We continue to monitor developments in the industry and will update these measures as necessary to ensure the continued safety of our products.
â€¢ We are an active member of the Pet Food Institute and an active participant in its review of pet food safety issues. We will implement recommendations of the PFI review as appropriate for our business.
â€¢ We will work with the FDA and other regulatory authorities and Congress to develop additional measures to protect against future occurrences of this type
Finally, we have filed suit against ChemNutra. ChemNutra sold us contaminated wheat gluten that did not meet our specifications and did not conform to the promises of quality that ChemNutra made to us. ChemNutraâ€™s actions have caused tremendous injury to the public and to Menu. Sometimes even well respected manufacturers, like Menu, suffer problems caused by others. We are working with the FDA and with our customers to resume our business of providing nutritious, high-quality pet food for animals throughout North America. We take pride in our products, and we also take responsibility for them. We intend to do everything in our power to
make things right for our customers and to prevent this type of situation from ever occurring again.
2) Charles Sweat- President, Natural Selection Foods
Mr. Chairman and members of the committee, thank you for allowing Natural Selection Foods the opportunity to be a part of the important discussion about food safety in this country. We are pleased to cooperate with the subcommitteeâ€™s investigation and this
hearing. My name is Charlie Sweat and I am President of the company. Before proceeding, I want to say that everyone in our company remains deeply saddened by the human toll the outbreak has wrought. We are a company founded on a commitment to providing the healthiest food possible. To learn that food processed by us could have brought anything other than good health was devastating. Natural Selection Foods, based in San Juan Bautista, CA, was formed in 1995 when the founders of popular organic produce brand Earthbound Farm partnered with 3rd-generation family farmers Mission Ranches. In 1999, Tanimura & Antle, another longtime family-run farming company, became a 1/3 partner in the company.
On September 14th, we received a call from the Food and Drug Administration and California Department of Health Services that there was an outbreak of E. coli linked to fresh spinach. We were shocked to learn that some of our products might be involved. Within 24 hours, at the suggestion of the investigators, we voluntarily recalled all products containing spinach under all brands packaged in our facilities, based on patient recollection. Five days later, lab tests would confirm the presence of matching E. coli in a bag of non-organic spinach that we packaged. Our companyâ€™s long-standing policy has been to provide open access to government
regulators and investigators. Once we were provided with manufacturing codes from bags of spinach in which the outbreak strain was found, we were able, within hours, to trace back to the ranches that provided that spinach.
Throughout the investigation, we have been cooperative, available, and open, working round the clock with the FDA and CDHS investigators to assist and support their work. Investigators had access to our staff, our facility and our records. From day one, we have been as eager as anyone could be to understand where the problem originated and how this could have happened.Recently the FDA and CDHS released a joint report on the incident. The report clearly states that no specific transmission vehicle has been identified, but the reportâ€™s findings point to what we believed from the beginning: the contamination appears to have been somehow linked to the natural environment in which the spinach was grown. Samples matching the outbreak strain were found on a cattle ranch, just under a mile from where the spinach was grown, but never on the spinach field itself. Prior to the outbreak, Natural Selection Foodsâ€™ protocols met or exceeded industry best-
practices, including FDA suggested Good Agricultural Practices and even the FDAâ€™s very-recently issued Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables. We follow Good Manufacturing Practices as outlined in the Code of Federal Regulations which are verified by daily audits. Further, we participate in the USDAâ€™s Qualified through Verification program â€” a voluntary program of unannounced inspections for fresh-cut processors that verifies the strict Hazard Analysis Critical Control Point program we follow in our facilities. Participation in QTV requires that our facilities are inspection-ready every day â€” a demand far more rigorous than what is called for by programs whose inspection schedules are known in advance.
In addition, as we constantly strive to improve food safety on every front, we have worked in research and development for more than three years to perfect a laser sorter that identifies and removes foreign objects in our product stream (such as roots, twigs,
rocks). This industry leading, cutting edge technology had recently been installed in our facility. Following the laser sorting, the greens are thoroughly washed in agitating chilled, chlorinated water and every package is passed through a metal detector. Our experience strengthens our resolve to challenge the thinking about food safety in produce and develop new protocols that significantly heighten the safety of our products. Our efforts in this regard started almost immediately. While simultaneously working collaboratively with FDA and CDHS investigators and coordinating our recall, weâ€™ve worked tirelessly with some of the top scientists in the country to completely reinvent what state-of-the-art food safety means in fresh produce. Weâ€™ve also worked with independent researchers who had been dealing aggressively and successfully with the problems of E. coli in food. Dr. Mansour Samadpour of IEH Laboratories, one of the countryâ€™s top food safety scientists, has worked extensively with the beef industry in improving safety protocols and reducing outbreaks associated with beef; he has become a valuable consultant to our operations. In addition, we have
established a food safety advisory panel consisting of some of the premier food safety scientists in the country, including top academics from the University of Georgia, Rutgers, and U.C. Davis. They are working with us in the development and
implementation of the strongest food safety, integrity, and quality measures possible, exceeding anything in place today and setting a new standard for the fresh-cut produce industry.
Within two weeks of the recall, we had launched an unprecedented program of pathogen-specific testing in all of our raw, leafy greens. We lab-test all salad greens arriving at our facility for potentially illness-causing E. coli and salmonella. All greens are
held until the tests are completed and only those greens that show no presence of these pathogens are released for processing.
In February, we launched a finished product testing program as a final hurdle, following the same protocol as our raw product test and hold program. We believe that this kind of testing is a key safety measure for produce that will be consumed raw, since cooking
is the only proven kill step for E. coli.
Natural Selection Foods has also signed on to the California Department of Food & Agricultureâ€™s new Leafy Green Handler Marketing Agreement. The intent of this agreement is to verify and certify that signatories are following industry guidelines for
leafy greens production, using a USDA-designed inspection program in use around the country for other commodities, and CDFA inspectors. Companies who have signed on agree to purchase leafy greens only from growers who follow the accepted set of Good
Agricultural Practices. This is a good, first step for our industry, demonstrating that as an industry we are committed to improving food safety. However, the GAP Metrics accepted by the Leafy Greens Marketing Agreement Board, in their current form, are not enough. Much more needs to be done and we will continue to work actively within the industry and with regulators to encourage the development of standards that provide the strongest level of food safety possible. We welcome regulation in this arena, but also believe strongly that with or without regulation, it is incumbent upon the individual companies and our industry as a whole to act to improve food safety. Private industry can and should move faster than the regulatory process. We have demonstrated that at Natural Selection Foods.
Everyone at Natural Selections Foods cares deeply about this outbreak and its victims and is committed to solving this vexing problem. We have faced many challenges in our 23 years, but none as great or important as this. As terrible as the outbreakâ€™s effects
have been for many, we believe that good can be extracted from it â€“ that as a country and as an industry we must share a renewed focus on food safety and an unrelenting commitment to find solutions to this difficult problem. Again, we appreciate the opportunity you have given us to be a part of this important discussion today.
3) Mr. David Colo- Senior VP of Operations, ConAgra Foods
Good morning Mr. Chairman and Members of the Committee. My name is David Colo, and I am Senior Vice President of Operations for ConAgra Foods, Inc., where I have worked in various positions for the last five years. Thank you for your invitation to testify today about this important topicâ€”the safety of the nationâ€™s food supply. I want to assure the Committee that we are fully aligned with its objective of ensuring that our food supply is among the safest in the world. ConAgra Foods is one of North America’s leading packaged food companies, serving grocery retailers, as well as restaurants and other foodservice establishments. Popular ConAgra Foods consumer brands include: Banquet, Chef Boyardee, Egg Beaters, Healthy Choice, Hebrew National, Huntâ€™s, Marie Callenderâ€™s, Orville Redenbacherâ€™s, PAM and many others, including Peter Pan. We operate over 100 manufacturing facilities in 30 states, as well as facilities in several international locations. I appreciate the opportunity to share with you ConAgraâ€™s recent experience
related to the finding of Salmonella Tennessee in our peanut butter products, including our Peter Pan brand peanut butter.
First and foremost, we are truly sorry for any harm that our peanut butter products may have caused, and we intend to resolve any claims arising from the consumption of our peanut butter products as fairly and expeditiously as possible. As the head of operations for this company, I can assure you that, not only do we take these issues very seriously, but we take them personally because consumer safety has always been our top priority. There are four main messages that I want to convey to you today. First,
within hours of its initial telephone conference with both the Food and Drug Administration (FDA) and the Centers for Disease Control regarding this potential issue, ConAgra Foods took prompt action to protect the public health by ceasing all production and distribution, and voluntarily initiating a recall of all peanut butter in the marketplace manufactured at its Sylvester, GA facility, the
only ConAgra facility manufacturing peanut butter. Second, the company conducted an in-depth investigation into the potential root cause or causes of the Salmonella Tennessee contamination. Third, ConAgra will ensure that, before it resumes operations at its Sylvester, Georgia facility, it will have addressed all the potential sources of Salmonella contamination, such that the facility will serve as a model in the industry for the production of safe and quality product. And, finally, ConAgra is taking steps to improve food safety standards for all its food products. I would add that, since this issue first surfaced in mid-February, we have worked
cooperatively with FDA, CDC and the state of Georgia food safety officials. We have also been pleased to cooperate with this Committeeâ€™s investigation. Let me now describe these points in greater detail.
ConAgra first became aware of a potential issue the evening of February 13, 2007, when the FDA contacted the company to schedule a call the following day to discuss an epidemiological study conducted by the CDC that suggested ConAgraâ€™s peanut butter products may have been linked to a Salmonella illness outbreak. The next day, February 14, after a series of telephone conversations with both the FDA and CDC, the company initiated a voluntary recall from the market of 100 percent of the peanut butter manufactured at our Sylvester, Georgia facility. The company simultaneously ceased all production and distribution of peanut butter products from that facility. Throughout the process, ConAgra worked closely and cooperated fully with FDA in all aspects of the recall, including in the collective efforts of the company and FDA to inform the public about the scope of the recall.
In addition to initiating this prompt and comprehensive recall, the company initiated a full investigation to determine the root cause or causes of any potential Salmonella in the product. ConAgra worked with the FDA to identify any potential
source of contamination. On February 22, eight days after ConAgra first initiated the voluntary recall, it was notified by FDA of state laboratory findings confirming the presence of Salmonella in the companyâ€™s peanut butter products. ConAgra made a public announcement to this effect that same day, and FDA made a similar announcement the following day. Based on its investigation, ConAgra believes that raw peanuts and peanut dust introduced some low levels of Salmonella Tennessee into the plant. The
presence of Salmonella is not unusual on raw agricultural products like peanuts. It appears that moisture then inadvertently entered the production facility and enabled the growth of low levels of dormant Salmonella Tennessee. We believe the moisture was likely the catalyst that temporarily allowed the Salmonella Tennessee to grow inside the facility. We further believe the Salmonella Tennessee
subsequently came into contact with peanut butter prior to packaging. Finally, we believe the rate of subsequent contamination was low and, as such, was not detected by our finished product testing program which employed standard industry
ConAgra will ensure that, before it resumes operations at its Sylvester, Georgia facility, it will have addressed all the potential sources of Salmonella contamination, such that the facility will serve as a model in the industry for the production of safe and quality product. The Sylvester, Georgia plant is the only ConAgra location where peanut butter is manufactured, and this facility has been idle since the recall was initiated on February 14th. No Peter Pan peanut butter has been sold by ConAgra to its customers since that date. ConAgra is continuing to work closely with the FDA to ensure that when operations resume in the Sylvester plant there will be no reoccurrence of this issue. The company is committed to addressing the suspected causes of the contamination,
and it will implement significant changes in the plant, including installing new, state-of-the-art machinery, technology and designs throughout the facility. The estimated minimum cost of these facility modifications is $15-$20 million. These costs are in addition to the $50-$60 million cost associated with the recall and the significant costs associated with the ongoing loss of sales.
Before resuming operations, the company will obtain an independent review by an expert third-party and seek the concurrence of the FDA as to the adequacy of the measures implemented. ConAgra is committed to taking the time necessary for each of these steps, and we estimate that the facility is not likely to reopen until August. While we are making these upgrades, we will partner with a reputable third-party manufacturer to produce Peter Pan peanut butter to the highest quality standards and to begin shipping product to retailers this summer.
ConAgra Foods is taking steps to improve food safety standards for all its food products. In addition to its thorough investigation at the Sylvester facility, ConAgra is conducting additional comprehensive inspections of its manufacturing facilities throughout the company. We have assembled a team composed of internal experts, along with an external specialist in food safety, that is in the process of visiting ConAgraâ€™s plants, contract manufacturers, and suppliers. To bring additional focus and leadership to developing and implementing programs that continuously improve product safety and design, the company has appointed a recognized and well-respected food safety expert to a company-wide leadership position, Vice President for Global Food Safety. This action will bolster our existing, substantial food safety and quality expertise, and will consolidate responsibility for existing and future company-wide oversight of food safety initiatives and systems. The company has hired Paul A. Hall, a leading expert with
more than 30 years of experience in microbiology, food safety and food quality, to fill this position. Hall joins ConAgra Foods from Matrix MicroScience, Inc., a leading producer of technology for the rapid concentration, capture and detection of foodborne pathogens, including Salmonella. Previously, he held product safety and quality-related positions of increasing responsibility at another major food company. We are also forming a Food Safety Advisory Committee, composed of leading independent, third-party experts in food safety, which will provide guidance to the company as part of our ongoing work with government agencies, research
institutions, and scientists in the areas of food production and testing. This advisory committee will provide guidance to the company in the areas of food production and testing, and will advise the company in its plan to fund research involving the detection, control and elimination of foodborne pathogens. The committee will be chaired by Dr. Michael Doyle, director of the Center for Food
Safety at the University of Georgia and one of the foremost authorities on foodborne pathogens in the world. The company is currently working with Dr. Doyle to identify other members of the committee. There is nothing more important to ConAgra Foods than the safety, quality, and wholesomeness of our products. Through our work with the Food Safety
Advisory Committee, we will be able to leverage their expertise to ensure that we take all reasonable steps to minimize the risk of foodborne illness.
Taken together, these measures reaffirm our commitment to food safety and quality. The company will continue to work closely with the FDA going forward and appreciates the excellent work of the FDA and CDC throughout this process. We also thank our consumers and customers for their understanding, as well as for the role they have played in ensuring public safety by returning and disposing of the recalled product.
Again, we are truly sorry for any harm that our peanut butter products caused and intend to resolve claims arising from consumption of our peanut butter fairly and expeditiously. We plan to make all changes necessary to the manufacturing environment to ensure this situation does not occur again. We are committed to the highest possible standards of food safety throughout our operations and believe the measures we have outlined today will clearly meet that commitment.
4) Mr. Stephen Miller - CEO of ChemNutra (has his attorney with him)
Thank you, Mr. Chairman and members of the Committee, for inviting me to testify today on a subject that is so clearly important to many in this nation, the safety of pet food and the food supply in general.
My name is Steve Miller and I’m Chief Executive Officer of ChemNutra. ChemNutra is a small business, headquartered in Las Vegas, Nevada. I am here today with ChemNutra’s FDA attorney, Marc Ullman of Ullman, Shapiro and Ullman.
Before I proceed, on behalf of ChemNutra I want to express our support and condolences for pet owners whose pets have fallen ill or died as the probable result of contaminated pet food, as well as pet owners throughout North America who have become fearful about their pets’ food following news of the contamination. We also offer our empathy
for the difficulties imposed on pet food businesses that were negatively impacted by this situation. We import high-quality nutritional and pharmaceutical chemicals from China to the United States. Those products come from manufacturers either known to us personally or recommended to us by a number of reputable and well-qualified trading agents with whom we have had long-
standing relationships. Our US customers are manufacturers of pet food, and nutritional ingredients who want high quality, the best service, and the most competitive prices.
Until March 8th of this year, ChemNutra had never had an issue or incident with its Chinese manufacturers, all of whom provide certificates of analysis of their products, which is standard operating procedure for U.S. importers. It was on March 8 that
ChemNutra first learned that wheat gluten was one of many ingredients Menu foods was investigating as suspect in cat illnesses. That was nearly three weeks, according to Senate testimony, after Menu Foods first learned of possible contamination of pet foods.
On that date, March 8th, notwithstanding what we believed to be a remote risk at that time, ChemNutra quarantined and ceased all shipping, sales, and marketing of wheat gluten in our possession, from all sources. On March 16th, Menu Foods issued its first recall and in doing so, made no mention of wheat gluten. In fact, Menu Foods said at that time that it is testing some 20 ingredients, but to date, we have not heard a word about those testing results. Shortly thereafter, on March 19th, we received a request from the Food and Drug Administration for all documents relating to wheat gluten, to which we immediately and fully complied. However, it wasn’t until March 29th that ChemNutra heard for the first time that the FDA had found melamine in its wheat gluten, without quantification as to how much. Between March 29th and April 1st, I was in China and in communication with the FDA. Upon hearing of the traces of melamine, I spoke with the president of our supplier, XuZhou Anying Biologic Technology Development Co. Ltd, who said he didn’t know there was melamine in their wheat gluten or how that could have happened. He promised to look into it and, to this date,
has not provided us with additional information despite many follow-up contacts on our part.
On April 2nd, after receiving further information from the FDA, we issued a formal recall of the contaminated wheat gluten. It’s important to note that on March 8th, when ChemNutra ceased shipments of its wheat gluten, we had only four customers for that
product, one of which was Menu Foods. Prior to any scheduled shipment, customers were made aware that our shipments were stopping. It has been more than a month since this dreadful issue became manifest. Over this period there have been a raft of surmises and suppositions, but few facts. At this point, the only piece of information of which we can be certain is that melamine was contained in a shipment of wheat gluten we imported through XuZhou Anying Biologic Technology Development Co. Ltd. However, we at ChemNutra strongly suspect, at this point, that XuZhou Anying Biologic Technology Development Co. Ltd may have added melamine to the wheat gluten as an “economic adulteration” designed to make inferior wheat gluten appear to have a higher protein
content. They can sell it to us at the price we would pay for a higher-quality product because the melamine, our experts tell us, falsely elevates the results of a nitrogen-content test used to assess protein content. Melamine is not something that we or, anyone else, including the FDA was ever testing for in the past, though of course we are now. We have recently been told that there was a prior history of this same kind of economic adulteration related to a similar agricultural commodity about three decades ago, where this commodity was adulterated with urea, another nitrogen intensive additive, which had at the time become inexpensive enough to economically use to fool the protein testing. Subsequently, that commodity has been tested for urea.
I want to thank the committee for this opportunity to tell the ChemNutra story in an unvarnished and factual manner and I hope that my testimony today will help you develop protocols, regulations or laws that will preclude this sort of event from
occurring in the future.
Stupik: You indicated that your company had four customers and one of them was Menu Foods and the other three customers that you shipped the wheat gluten to, is that correct? What do they make?
Miller: 2 of them make pet food and the third distributed wheat gluten to pet food companies.
Stupik: So, it basically all went to pet food.
Miller: Yes, all pet food.
Stupik: Once you realize that melamine may have something to do with this, with the problems, the deaths and the illnesses, what did you do with the wheat gluten that you had left?
Miller: All of the wheat gluten has ever since March 8 has been in our warehouse and has basically been quarantined.
Stupik: Do you have any plans to dispose of it?
Miller: We are working with the FDA right now to dispose of it in ways that are acceptable to the FDA.
Stupik: Okay. Mr. Colo, on behalf of ConAgra, in October 2004, you found salmonella in your peanut butter, right?
Colo: That’s correct.
Stupik: And in March 2005, the FDA asked about that salmonella and if you had any troubles, is that correct?
Colo: That is correct.
Stupik: And the FDA says that they asked for information and I understand that ConAgra says put it in writing. Either way, the FDA never obtained the information that they were looking for based on the salmonella 2407, right?
Colo: The situation, just to be clear, was that we had a positive salmonella unfinished product that we had held at our facility. The product was never shipped from our Sylvester, Georgia facility. It was contained and destroyed in the process.
Stupik: The FDA asked for those records.
Colo: The FDA asked for the records.
Stupik: In ‘05.
Colo: In Feb ‘05, that is correct.
Stupik: They have never been provided to the FDA.
Colo: We simply asked the FDA to request the information in writing. And that we would be happy to forward the information. The FDA never put in a written request.
Stupik: Did the FDA follow up after March ‘05? Did they follow up with ConAgra and ask for the information without putting it in writing?
Colo: No they did not and it was February ‘05.
Stupik: Has there been any other time in which the FDA or USDA asked ConAgra in regards to e.coli, salmonella, botulism about possible contamination and ask for your records and in which ConAgra did not provide it to the FDA?
Colo: Again, what we would do in that typical situations is to simply ask the FDA to request the information in writing.
Stupik: Correct. But I’m asking if there are other incidents. There are some rumors circulating around here that ConAgra just says to put it in writing and stonewalls it and the request never happens. It happened in October 2004 and they followed up in March ‘05. The point I’m trying to make is that is there any other time in which information was requested but not provided whether it’s in writing or not.
Colo: I’m not aware of all of the requests that would come from the FDA, so I’m not sure that I can answer that question appropriately at this time.
Stupik: Alright, can you check and follow up with the committee? We keep this record open for 30 days, so you can check and follow up with us.
Stupik: Okay. Mr. Henderson, you indicated that I think you used the word fraud in your testimony- that this melamine placed was a fraud- it was intentional.
Stupik: Wheat gluten is used in other items other than pet food. Correct?
Henderson: That would be my understanding. Yes. Pizza as an example.
Stupik: Human food like tofu and other things like this. Correct?
Henderson: That is correct.
Stupik: Then, what happened to you, is there any way that we know if other wheat gluten or products or if other things were intentionally altered and you don’t know until after the fact, right?
Henderson: You don’t know until after the fact. Certainly, the presence of melamine was a particular problem during this process simply because it was a foreign additive or contaminant. There wasn’t a testing protocol for identifying it. What we are aware of is what happened to us. If it’s happened before or if it’s happening now…
Stupik: You don’t know. And you place your order through Mr. Miller’s company, correct?
Henderson: That’ s correct.
Stupik: And he ships it to you.
Henderson: Yes, he does.
Stupik: And Mr. Miller, you receive it from China, right?
Stupik: And before this incident, did you do any testing of any products that came from China?
Miller: No. There was no known issue to look for.
Stupik: You indicated that your supplier in China basically was recommended to you by other people in the industry.
Miller: My trading company that we have worked with for a long number of years and that we had a lot of confidence in.
Stupik: And you have used this company before?
Interrupted by a representative: Mr. Chairman, I unanimously agree that we all be given 10 minutes to ask questions.
Stupik: Okay. So, you have used these companies before for wheat gluten?
Miller: Yes, we have.
Stupik: And never any trouble.
Miller: No trouble whatsoever.
Stupik: Have there been any complaints about their products before? Or about that low protein content before?
Miller: This was a new product for us.
Stupik: From this company. You’ve used this company before in China but not for this product.
Miller: This was the first company that we imported from. We just started last fall in this business. This is a new product for us.
Stupik: Okay. Mr. Sweat, we have some testimony earlier showing that (picks up a bag of spinach) this comes from Salinas, CA. Does this come out of your plant?
Sweat: I would have to look at the production code. Does it start with a J or a Y?
Sweat: That would have come out of our Arizona facility. We have a plant in San Juan Batista, CA and we have a plant in Yuma, Arizona.
Stupik: Is San Juan Batista considered part of Salinas Valley?
Sweat: It’s about 25 miles north of Salinas.
Stupik: There’s been some discussion about being completely washed. What does that mean?
Sweat: That is what we do in the facility after we harvest. We mix them into a mixing belt for the different ingredients and then they go to a chilled, chlorinated wash. That chlorine is used as a sanitary wash.
Stupik: It does not take out e.coli.
Sweat: It is not a kill step. It is a deterrent for microbial load, but it is not a kill step.
Stupik: Prior to this incident, did you do any testing for e.coli?
Sweat: In the 22 years that we have been in business, we’ve never had a food borne illness, so our GAP programs that we had in the fields and our programs have been under control.
Stupik: But you have been in the Salinas Valley, where there has been 20 different recalls including e.coli, and the company never felt it necessary to do testing?
Sweat: We weren’t involved in any of this, so I don’t know what the issues were in those. What we did do as a result of this outbreak, we got outside of the box a little bit. We went to the beef industry to learn about what they were doing and that’s how the testing programs that we implemented a couple of weeks after the outbreak were derived from.
Stupik: It says that this is a product of USA and Mexico (holding up bag of spinach). But you said that this is from Yuma. Would part of this salad come from Mexico too?
Sweat: It potentially could. We do have farms in Mexico that we bring products from into the US zone.
Stupik: Understanding that it comes into your plant. Once it comes in, out of your fields, it comes and shipped in one of these plastic containers. Even though it says Dole, it comes from your plant.
Sweat: It’s our processing facility, but then Dole picks up that product from our facility and then they distribute it out.
Stupik: Has the FDA ever inspected your facility?
Sweat: Yes, we have worked with the FDA on a collaborative basis on our programs over the years. They come in frequently.
Stupik: How frequently?
Sweat: The last time they were there was in August reviewing our facility.
Stupik: Of ‘06?
Sweat: August 2006- the week that e.coli was linked.
Stupik: Did they do any testing or did they just come and look around?
Sweat: What they do is and they come and look at our documents. We provide them with our documents and they review all of our compliance with all of the programs.
Stupik: But you’re not required to do any testing?
Sweat: The voluntary regulations and guidelines from the FDA do not require any testing of the product.
Stupik: So, they are just looking at how your handling the product?
Sweat: They are just looking at our processes.
Stupik: So, other than just making sure your area is sanitary, there is no testing for e.coli that is done by the FDA.
Sweat: There is none done at this point in time.
Stupik: Mr. Henderson, Menu Foods is in the US and Canada.
Henderson: Yes, we are.
Stupik: Are you inspected by the FDA?
Henderson: We have been inspected in the Pennsauken facility in 2006 by the FDA.
Stupik: In 2006. Do you recall any time before 2006 by the FDA?
Henderson: We have been inspected prior to that, but I don’t have the dates.
Stupik: Every year do you think?
Henderson: Our head of technical services estimated that it is about once a year.
Stupik: Do other agencies inspect your plant?
Henderson: The USDA inspects us once a year. The Canadian plant is inspected once a year by an equivalent. We are inspected by both the UDSA and the CFIA to allow us to export to Europe. So they are not only looking at it from the US and Canadian protocols but also from the European protocols.
Stupik: Let me ask you this, we’ve had some outbreaks in wheat gluten in San Francisco, France, Canada, Connecticut, and in your place. Do you get together and share information when you hear of outbreaks in other areas like in France or in Canada? Or is it only if it involves your company.
Henderson: Excuse me, get together with whom?
Stupik: Other authorities from Canada to see what’s going on if you have detected something in France if it’s all wheat gluten. Wheat gluten is a big part of your product here.
Henderson: Relative to this experience which is the only one that I can relate to, we’ve essentially coordinated with the FDA, the FDA was in touch with European authorities, and the Canadian authorities and we relied on them to be the communication.
Stupik: But company to company, there is no contact back and forth and it is only through your regulatory agency.
Henderson: In that particular case, the company is also a member
— Sorry. We had a computer glitch, so the webcast stopped for us and since it is no longer airing, we have to wait for the hearing to be archived and it should be back up later today and we will transcribe the rest of the hearing then.