Summary of the Pet Food Recall
From the very beginning, it was assumed it would be a problem easily solved and concluded in short order. That science would find the exact cause and offer a quick, easy solution. However, it has been far from easy. And, science is unable to offer the quick, easy solution many are seeking. It has left many pet owners wondering what food is safe, and suspicions that enough is not being done. Not helping has been the introduction of the political dynamic into the situation along with rumors and misleading information in the media and Internet passing as proven fact,making an already difficult situation more so.
The FDA has proceeded in a steady, methodical approach. An approach to clearly ascertain the precise facts that led to this crisis. To determine and understand why this particular substance, melamine, is affecting animals in this manner. And, whether melamine would have the same adverse impact if it entered into the human food supply.
To fully understand the scope of the situation at hand, it is necessary to review what we know from the beginning.
In mid-March, Menu Foods began a voluntary recall of all of the "cuts and gravy" style food manufactured between December 2006 and March 2007 after receiving reports that their products were causing sudden illness and death among cats and dogs. In their standard analyses, Menu Foods was unable to find the cause. They notified the FDA and Canadian authorities of their intent to recall and proceeded to do so.
A week after the recall began, the New York State Food Safety Laboratory released findings indicating the rodenticide, aminopterin, was the cause of the illnesses and deaths. They further indicated the aminopterin had contaminated the wheat gluten used as an ingredient in the production process. FDA laboratories and the Cornell School of Veterinary Medicine continued their analyses. They were unable to corroborate the New York State results. A separate analysis by the University of Guelph (Canada) was only able to find trace amounts of aminopterin in the recalled food. Those amounts were substantially lower than toxic levels, at levels that would not cause sickness. It was also unclear whether aminopterin poisoning would cause these type of symptoms.
Two weeks into the recall, the FDA and Cornell labs found a plasticizer known as melamine to be present in the contaminated food as well as melamine crystals in the kidneys of a deceased cat. They determined the crystals were in sufficient quantity to cause kidney failure. In trying to find fast facts on melamine, the media erroneously reported that melamine, itself, is used as a "sometimes" fertilizer in Asia. Melamine cannot be used as fertilizer, in particular as a nitrogen-fixing fertilizer, due to its chemical structure. When melamine is reacted with urea, though, a usable fertilizer is created. However, the EPA has banned the use of any melamine-based fertilizer. Also, urea-based fertilizers were banned by the EPA in the early 1970s. Both types of fertilizers are considered as unsafe for food crop production. Any food crop grown using these type of fertilizers are banned for import into the United States (unsafe for human and animal consumption).
At this point, the FDA inquiry continued to determine which ingredient was contaminated by melamine. They also needed to determine the scope of the contamination while trying to limit the impact on animal health. The source of the contamination pointed back to a wheat gluten product imported from China. This was particularly bothersome considering the import prohibitions (unfit for animal and human consumption) placed on all Chinese wheat and wheat products entering the United States.
Setting aside the regulatory violation issue, the FDA continued to pursue the investigation along several parallel tracks. One track was to follow the "paper trail," that is the collection of all documents with regard to the imported wheat gluten. The analytical and scientific track to properly develop a laboratory protocol to detect melamine in food and biological specimens. And, to determine and understand the effects of melamine poisoning on cats and dogs. All needed to determine the scope of the contamination problem and its effects.
The recall list increased each week since the initial notice. At present, more than 100 different foods, affecting all brands (major, store, and lesser known) have been listed. The finding of contaminated wheat gluten sent a powerful ripple through the widening crisis. Many pet owners assumed all wheat gluten was suspect, including wheat gluten manufactured in the United States from US-grown wheat. Further, the fear of the other two vegetable glutens, rice and corn, being contaminated in the same manner began to spread. The spreading fear also extended to whether the package labels were accurate, and whether glutens are necessary.
The various tracks followed by the FDA produced results. The document review showed incomplete and improper bills of lading. Many shipments were found to have been trans-shipped through third nations since direct import of all Chinese wheat and wheat products is prohibited. Also found were inaccurate product lot analyses. This suggested a deliberate attempt to adulterate the source of the wheat gluten and to hide its source.
On the laboratory front, once melamine was identified as the primary cause, the development of a proper analytical protocol was fairly straightforward. For additional capability, analytical protocols for melamine and melamine related compounds were developed and incorporated into the screening process. Also, under development is a new method to determine the quality and quantity of vegetable protein content that can be easily incorporated into the screening process.
The most difficult track undertaken by the FDA is to determine and understand the effect of melamine on cats and dogs. Information on melamine toxicity is extremely limited. A single, animal study was conducted in the late 1940s. A group of dogs were fed their normal diet with melamine mixed in. The dogs suffered no ill effect, except for increased urination. Based on these results, it was decided additional animal studies were not necessary.
The FDA, knowing veterinarians had the most information, asked for access to treatment records of those cats and dogs that exhibited signs of kidney failure and kidney disease. Of the treatment information received, Banfield veterinary clinics, found in most PetSmart stores, provided a wealth of information. Potentially, the Banfield records is providing the most comprehensive overview of the problem. In the review of treatment records, the FDA is sorting which kidney illnesses are from normal disease processes and those from the consumption of contaminated food.
While it was hoped the contamination would be limited to imported wheat gluten, a shipment of rice protein concentrate from China was found to be similarly contaminated with melamine. Unfortunately, a portion of this shipment had already been distributed and used in pet food manufacture. Additionally, a full inspection of the shipment found melamine labels stamped onto the bags containing the rice protein concentrate.
However, the larger, "worst case" scenario arose when hogs were found to have consumed "salvaged pet food." The "salvaged pet food" was not salvaged from pet food sources from the recalled products as some media reports suggested. It is actually manufactured animal feed that included the contaminated wheat gluten and unused pet food remaining in the plant. A quarantine hold was placed on the hogs to prevent entry into the food cycle. To determine the level of feed contamination, samples were collected and tested. The analyses yielded varying results. Some samples were found to contain trace and sub-trace amounts of melamine and melamine-like substances while other samples tested negative. Also, in the analyses of the hogs' excrements, trace amounts of melamine were detected. Contrary to media reports, none of the hogs were processed or consumed.
A few days later, 20 million chickens at various poultry farms were also placed under regulatory hold. It was determined their feed was also manufactured with contaminated wheat gluten. Likewise, analyses of their feed samples were performed. Similarly, some feed samples were found to be contaminated with trace and sub-trace amounts of melamine and melamine-like substances while other feed samples tested negative. Likewise, chicken excrement was collected and tested. Similarly, trace amounts of melamine and melamine-like substances were detected in the excrement.
Shortly after the chicken feed issue arose, a similar problem with contaminated fish meal used to feed farmed fish was found. In this case, the contaminated fish meal was manufactured in Canada with a shipment of contaminated wheat gluten directly imported from China into Canada. Though most of the fish meal was distributed and used, a portion of the Canadian-made fish meal was imported into the United States and used at several fish farms. The fish that were fed the contaminated feed are very small and are not suited for entry into the food supply.
In a discussion of the results between the FDA and USDA, both came to the conclusion that very minimal amounts of melamine and melamine-like substances were found in the contaminated animal feed and should not present any danger provided the contaminant concentrations remained at these substantially minimal levels. Also, a dilution effect was being seen. Since the hogs and chickens were excreting any ingested melamine without ill effect, very little, if any, melamine and melamine-like substances would remain in their meat. An animal risk assessment study by the USDA was undertaken. A random selection of hogs, chickens, and farmed fish were culled from the large population held in quarantine. The meat was subjected to a variety of analytical tests, primarily to determine if residue from melamine and melamine-like substances were present. The tests came back negative - no residue was detected. The conclusion is that the hogs, chickens, and farmed fish are completely eliminating melamine and melamine-like substances, thus making them safe for consumption. (A person would have to eat 800 lbs of contaminated pork, chicken, or fish in one meal to approach toxic levels.) Additional animal risk assessment studies by the USDA are being conducted and planned.
While this was playing out, the FDA was able to further determine significant labeling errors were made. What was labeled to be rice protein concentrate was actually wheat gluten. And, what was labeled as high-protein wheat gluten had a high level of wheat flour. This finding further indicated there was a deliberate effort to provide misleading information on the product lot analysis in addition to improper labeling, both regulatory violations. It also suggests the imported rice protein concentrate may not be contaminated, but it remains under import prohibition pending further review.
Though corn gluten has not been affected, it is undergoing the same level of testing. It should be noted the United States produces much of the world's corn supply, and the need to import corn and corn-related products from foreign sources into the United States is very minimal. Corn grown outside of the United States is lesser in quality and quantity. Only corn grown in Canada matches in quality of that grown in the United States. Canadian corn has been hybridized to accommodate their short growing season.
The more recent food recalls are related to possible cross-contamination issues. Those plants used to manufacture contaminated food are concerned new food made with "clean" ingredients are becoming contaminated with residue from the previous productions. If cross-contamination is happening, that means those plants that made the bad food failed to thoroughly clean their plant and equipment.
The investigation at the onset, from the scientific and analytical end, was "the needle in the haystack" type of work. Once they were able to determine cause, the rest of the work is step-by-step process, building on the previous results. The tracing of documents, shipments, and plant inspections are largely detective type work. The ability of the FDA to gather a large amount of information in a relatively short period of time to piece together a picture of what happened is a testament of its capability and resourcefulness. Certain key pieces of information still need to be developed, most especially the Chinese factor. (The records suggest importation through third nations began in the mid-1990s as "locked-in" trade concessions and agreements.)
How this situation will be resolved remains to be seen. Both the FDA and USDA recommends patience while the investigation proceeds. Whether this investigation results in an outright ban against some or all imported agricultural and food products (animal and human) remains unknown also. Much of the global market of food products has become interconnected.
They also continue to urge that the recalled pet food not be fed. They are still receiving reports that recalled pet food is still being fed despite being withdrawn from the distribution cycle. If you're unsure of what to feed, consult with a veterinarian. A constantly changing diet is not good for a cat or dog. If you intend to home cook, make sure you have the necessary foodstuffs, ingredients, vitamins, and essential amino acids a cat and dog needs for their daily dietary intake in addition to the proper cookbook that has recipes.
The outcome may eventually become what it has always been. It will be incumbent on the pet owner to monitor their pet's health and behavior.
Updates:
On May 25, 2007, the FDA released an Interim Risk Assessment Study with regard to livestock fed with contaminated animal feed, and whether a health risk to human consumption exists. The interim nature of study indicates the data already collected and new data collected is being reviewed on a continuing basis. The results of the study indicates the health risk, in its present form, is minimal. An individual would need to consume at least 800 lbs of contaminated pork, chicken, or farm-raised fish along with other melamine-tainted foods in a single day to approach toxic levels as stated earlier.
Subsequent to the assessment study, additional recalls of adulterated livestock feed and fish feed were initiated. The company involved made pelleted livestock and fish feeds that incorporated melamine as a binding agent in violation of FDA regulation. (Melamine is a banned substance for animal and human consumption.) The FDA performed analyses on both types of feed and found the levels that varied between differing lots, but well within levels cited in the interim risk assessment.
The affect of melamine and melamine-related substances on cats and dogs continued to be studied. Unfortunately, the process of reviewing the treatment information provided by veterinarians to the FDA has been time consuming.
Links:
FDA Overview Page: http://www.fda.gov/oc/opacom/hottopics/petfood.html
FDA Pet Food Recall FAQ: http://www.fda.gov/cvm/MenuFoodRecallFAQ.htm
FDA Import Prohibition Order (04-27-2007): http://www.fda.gov/ora/fiars/ora_import_ia9929.html
FDA Pet Food Regulation: http://www.fda.gov/cvm/petfoodflier.html
FDA Pet Food Label Regulation: http://www.fda.gov/cvm/petlabel.htm
FDA Pet Food Label Regulation (Special Foods): http://www.fda.gov/cvm/labelint.htm
FDA Ongoing Pet Food Investigation (Consumer Update): http://www.fda.gov/consumer/updates/petfoodrecallup.html
FDA Testing Methodology (Analytical Chemistry or equivalent background required): http://www.fda.gov/cvm/aboutor.htm
Interim Melamine and Analogues Safety/Risk Assessment (Analytical Chemistry or equivalent background required): http://www.cfsan.fda.gov/~dms/melamra.html
To Cat Trails | To Cat Crossings
© Copyright 2007 - David Ramos. All Rights Reserved.