USDA-FSIS – eFoodAlert

This is part two of a two-part opinion piece by Carl Custer. It first appeared in Food Safety News and is reposted here with permission.

In the previous article, I wrote about the decades-old public health problem of poultry-borne salmonellosis. This article will propose declaring the virulent strains that are pathogenic to humans as adulterants and the benefits of doing so.

Regulatory policies for other foodborne pathogens recognize consumer’s inability to handle them. The Code of Federal regulations, 9 CFR 311.2-39 describes a number of conditions for declaring meat carcasses adulterated, including: tuberculosis, arthritis, and odors. The poultry regulations 9 CFR, 381.80 et seq are similar. The Meat Inspection Regulations, 9 CFR 315.2 permit some meat products that are found adulterated under 311 to be passed for cooking – under the oversight of federal inspections, not in consumers’ kitchens. In 1995, the top administrator of the USDA’s Food Safety and Inspection Service (FSIS), Craig Reed, use that principle in his letter permitting lots of ground beef containing Escherichia coli O157:H7 to be cooked in a federal establishment – not in consumers’ kitchens.

Treatment of raw meat and poultry by cooking, irradiation, or high pressure processing would eliminate consumer exposure to those pathogens. However, one of the primary sources of foodborne pathogens now is contaminated produce. A growing body of scientific literature indicates a major source of these pathogens is food animal production via air ², water ¹, and manure ⁴. (These are only three recent papers of many). The 2018 meeting of the International Association for Food Protection (IAFP) in Salt Lake City had more than 20 sessions addressing preharvest contamination of soil, water and produce. There is also a large body of scientific literature on preharvest interventions in animals including isolation, competitive exclusion, probiotics, prebiotics, and vaccination.

Interventions cost and thus, producers need incentives. Incentives include altruism, regulations, customer specifications, and litigation. A 2018 IAFP Round Table “RT9: Do Lawsuits Play a Productive Role in Advancing Food Safety?” suggested that customer specifications and regulations produced faster results; lawsuits were too far in the future. The COSTO and Walmart speakers said customer specifications are effective. Regulation has had some effect on E. coli O157:H7 in beef, but certainly not eliminated it in either commerce or preharvest.⁶ One can only speculate what the results would be if FSIS had not declared it an adulterant in 1994. We know more each year what the effect is of not declaring outbreak strains of Salmonella as adulterants.

The FSIS has the legal means to prevent these adulterants from entering commerce. The Meat and Poultry Inspection Acts ^8-9 empower FSIS inspectors to conduct ante mortem and post mortem inspection of all animals before processing them into food. Traditionally, that has been visual inspection but not always. FSIS’s 2013 “Compliance Guide For Residue Prevention” uses laboratory results to compile a list, “The Residue Repeat Violator List.” It is composed of suppliers who have had more than one residue violation in the preceding 12 months. Thus, animals from a producer on that list present a “hazard reasonably likely to occur.” The HACCP (Hazard Analysis and Critical Control Point) rules require establishments to have controls to prevent any product with violative residues from entering commerce. Failure to do so is a violation of 9 CFR 417.6. FSIS can sample carcasses or live animals and the laboratory will report any violation to Field Operations for action.

The principle used for residues could be applied to outbreak strains of certain bacterial pathogens also. These strains are adulterants as defined by both the Inspection Acts and the Code of Federal Regulations. FSIS routinely samples carcasses and products for pathogenic bacteria. When an outbreak strain is detected and traced back to an establishment, the establishment can identify the producer and that producer would be put on a “Adulterant Carrier List.” Future animals from that producer and their products must either be treated to inactivate any adulterants or tested (ICMSF Case 15) until the producer has implemented validated controls and verified their effectiveness to prevent future contamination. If the establishment cannot identify the producer, then all product from that establishment would be treated or tested under ICMSF Case 15 to prevent any adulterants from entering commerce.

This would be a harsh rule and FSIS would likely be sued by the industry. The outcome should be similar to Texas Food Industry Ass’n v. Espy⁷ where E. coli O157:H7 was found to be an adulterant in ground beef because consumers would eat the product rare. So why not Salmonella? The difference would be that FSIS could use the half century of scientific findings that cross contamination within consumer’s kitchens is a major source of foodborne illnesses, not just undercooking. Thus poultry and other meat products would be included.

The outcome of FSIS promulgating such a regulatory policy would be that preharvest control of pathogenic bacteria in food animal production would begin to be addressed. This action would begin to reduce the environmental contamination that reaches produce fields via waterways and even highways⁵.

Assays for pathogens have advanced rapidly in the past decade³. Methods are more rapid, sensitive, and specific. The FSIS, processors, and producers can use these methods to rapidly verify that interventions are working and adulterants are not being found in products.

It would be wonderful if altruism was the incentive for preventing adulterants from entering commerce. Alas, we do not live in that world. But let us take USC 602 to heart and apply it to preharvest control.

References

¹. Alegbeleye OO, Singleton I, Sant’Ana AS. 2018. Sources and contamination routes of microbial pathogens to fresh produce during field cultivation: A review. Food Microbiology. 73: 177-208. https://doi.org/10.1016/j.fm.2018.01.003

². Berry ED, Wells JE, Bono JL, Woodbury BL, Kalchayanand N, Norman KN, Suslow TV, López-Velasco G, Millner PD. 2015. Effect of proximity to a cattle feedlot on Escherichia coli O157:H7 contamination of leafy greens and evaluation of the potential for airborne transmission. Appl Environ Microbiol 81:1101–1110. doi:10.1128/AEM.02998-14.

³. Besser, John M. 2018. Salmonella epidemiology: A whirlwind of change. Food Microbiology 71:55-59.

⁴. Heredia, Norma, Santos, García. 2018. Animals as sources of food-borne pathogens: A review. Animal Nutrition. In Press https://doi.org/10.1016/j.aninu.2018.04.006

⁵. Seedorf J, Schmidt RG.. 2017. The simulated air flow pattern around a moving animal transport vehicle as the basis for a prospective biosecurity risk assessment. Heliyon 3:00358

⁶. Swaggerty, Christina L., Ester Grilli, Andrea Piva, Nicolae Corcionivoschi, Steven C. Ricke, Todd R. Callaway. 2018. The First 30 Years of Shiga Toxin–Producing Escherichia coli in Cattle Production: Preharvest Intervention Strategies. Food and Feed Safety Systems and Analysis- Chapter 8. Pages 133–151 https://doi.org/10.1016/B978-0-12-811835-1.00008-7

⁷. Texas Food Industry Ass’n v. Espy, 870 F. Supp. 143 (W.D. Tex. 1994) US District Court for the Western District of Texas – 870 F. Supp. 143 (W.D. Tex. 1994) December 13, 1994

⁸. 21 U.S. Code § 455. Inspection in official establishments (Poultry Inspection)

⁹. 21 U.S. Code § 603 – Examination of animals prior to slaughter; use of humane methods (Meat Inspection)

Questions remain on source of euthanasia drug in Evanger’s and Against the Grain pet food

The Food and Drug Administration has completed its investigation into the supplier that furnished meat used in recalled canned dog food that was found to contain the animal euthanasia drug pentobarbital.

As yet unidentified, the supplier provides meat used in Evanger’s brand Hunk of Beef and Nutripack’s Against the Grain Pulled Beef brand dog foods, both of which are under recall. At least five dogs have required medical treatment and one died.

The FDA determined that the supplier appears to “… have systems in place to ensure that euthanized animals are segregated from animal protein going for animal food use,” an agency spokesperson said Thursday.

An FDA Form 483 Inspectional Observations report, however, will not be issued because such reports are only filed when investigators note deficiencies, which they did not do regarding the supplier for Evanger’s Dog & Cat Food Co.

Such animal protein meat suppliers are regulated by FDA and may also be subject to state jurisdiction, depending on the state in which they are located. No sub-agency within the U.S. Department of Agriculture has jurisdiction over this industry sector.

USDA’s Food Safety Inspection Service (FSIS) oversees slaughterhouses and meat processors that produce meat for human consumption. USDA’s Animal and Plant Health Inspection Service (APHIS) has no involvement in meat inspection at all, except for assisting suppliers with export certifications if they are exporting to other countries, according to a spokesperson for APHIS.

In a Feb. 19 letter addressed to “Dear Pet Parents” and posted on the Evanger’s web site, the company described its supplier as “USDA-APHIS inspected.” Staff from APHIS are now working with Evanger’s to clarify its authority, according to the APHIS spokesperson.

On Feb. 21, Evanger’s notified its customers that an independent test of the contents of a can of Hunk of Beef revealed the presence of horse and cow DNA in the product. The Sher family, which owns Evanger’s and Nutripack, cast blame on the meat supplier for the pentobarbital adulteration.

This is in contrast to FDA’s report that cans of Hunk of Beef obtained from the owner of the sickened dogs and from the retail location where the pet food was purchased contained beef. No Against the Grain samples were tested for species identification.

The cans of Hunk of Beef pet food were examined by a USDA-FSIS lab at FDA’s request. According to the test protocol, available on the FSIS website, the contents of a can of food would have been minced or diced and thoroughly mixed before analysis to ensure that the portion used for testing was representative of the entire can.

When asked to comment on the apparent discrepancy between Evanger’s independent DNA test result and the results reported by FSIS, a spokesperson for USDA-FSIS said the government did find trace amounts of pig and horse in the dog food.

“Although this was not an FSIS regulated-product, FDA requested that FSIS conduct speciation testing for Evanger’s Hunk of Beef dog food product,” the spokesperson said. “FSIS was contacted by FDA after they had determined that the Pentobarbital dog food product was adulterated with Pentobarbital. Agency speciation testing confirmed that the adulterated product was bovine (beef). Trace amounts of pork and equine were also found, but both were less than 2 percent and therefore not reportable.”

These trace amounts are consistent with incidental cross-contamination that can occur when meat from different species are processed on the same production line. The trace amounts of pig and horse do not explain the source of the pentobarbital-adulterated meat in the Hunk of Beef and Against the Grain dog foods.

The investigation so far

In a Feb. 17 consumer advisory, the FDA cautioned the public not to feed the recalled Evanger’s and Against the Grain canned dog food products to their pets. The products in question were recalled on Feb. 3 and Feb. 9 by Evanger’s Dog & Cat Food Company Inc. and Against the Grain, respectively, after pentobarbital was confirmed in samples of both products.

In conjunction with the advisory, FDA released two Form 483 Inspectional Observation reports. The reports detailed the conditions found by inspectors during visits to Evanger’s production facility in Wheeling, IL, and to the facility belonging to Nutripack LLC in Markham, IL.

On Feb. 21, Evanger’s notified its customers that the company was planning to expand the recall of Evanger’s and Against the Grain pet foods to include all outstanding production of Hunk of Beef, Braised Beef Chunks with Gravy, and Against the Grain Pulled Beef. Company officials told FDA they expect to release the official announcement of the expanded recall by the end of this week.

Kosher for animal use

In addition to marketing its pet foods as “human grade” and made with “USDA-inspected meats,” Evanger’s, citing an endorsement from the Chicago Rabbinical Council (cRc), promotes many of its products as “Kosher for Animal Use.”

A spokesperson for the cRc said the endorsement doesn’t mean the pet food is kosher in the traditional sense, but does mean certain expectations are met.

“When we provide a kosher endorsement we expect not only that all kosher laws are observed, but that the company acts in an ethical manner. While we cannot comment directly on this incident, we call upon all companies to maintain the highest standards of business,” the cRc spokesperson explained.

“Also, please be aware that Evanger’s’ products are NOT kosher in the regular sense. It is not kosher to consume, for anyone that observes kosher. It is endorsed by the cRc to feed it to one’s pet. Now animals of kosher observant individuals are not required to observe kosher — or any other commandment.

“The issue, and reason for the cRc endorsement, is that there are a few foods that not only may not be eaten by someone that is kosher observant, but one may also not derive any tangible benefit from them. An example would be leavened bread — Chometz — on Passover. It is those foods that a kosher observant person may not serve to their pets. The cRc endorses certain Evanger’s’ products that they are free from this concern, i.e. they do not contain any foods that a kosher observant person may not derive benefit from. It is for this reason that we do not allow Evanger’s to use the cRc standard kosher logo, to differentiate it from a standard kosher product.”

The cRc spokesperson further clarified that the presence of non-kosher species such as horse meat or pork would not be a concern in pet food.

Unanswered question

The FDA investigation into the Evanger’s case is still open and active. FDA has reviewed the customer list for the meat supplier and is in the process of following up as appropriate, according to a spokesperson.

While it may be comforting to the meat supplier’s other customers to learn that FDA found no deficiencies during the course of the recent inspection, the results leave a major question unanswered: Where did the pentobarbital-contaminated meat come from?

FDA continues to encourage consumers to report problems with Evanger’s products through the Safety Reporting Portal or by contacting a Consumer Complaint Coordinator. Please retain empty cans or partially used cans of food to facilitate collection of specific lot number information. Additional information is available on the FDA web page, How to Report a Pet Food Complaint.

This article first appeared on Food Safety News and is reposted here with permission.