OIG Questions E. coli O157:H7 Testing; Still No Approval Of Carcass Irradiation

In November 2009, U.S. Rep. Rosa DeLauro, Chairwoman of the House Agriculture-FDA Appropriations Subcommittee, asked the USDA’s Office of Inspector General (“OIG”) to investigate the efficacy of the Food Safety and Inspection Service’s (“FSIS”) N-60 sampling method to test beef trim for E. coli O157:H7.

In response, the OIG spent six months, from January to June 2010, auditing the FSIS’s N-60 program, and then issued the first portion of its findings in March 2011. Click on the following link to view a copy of the “Phase I” report. The detailed, 40-page report concludes that FSIS must thoroughly reevaluate its N-60 sampling program for testing beef trim.

The report demonstrates that an incredible amount of work has been done, and remains to be done, by both the OIG and the FSIS on this issue. The OIG has not yet even performed “Phase II” of its investigation. The bottom line is that FSIS will increase the amount of testing it performs for E. coli O157:H7.

While some positive changes will flow from the OIG investigation (perhaps from the Phase II evaluation of whether plants are following proper protocols for their own sampling and testing), there are valid questions about the investigation’s merit. Should so many more resources be invested in the concept of testing when we can never test to zero? As the prevalence of E. coli O157:H7 in beef continues to decrease, are we just going to continually increase our testing to look for a needle in the haystack that, thankfully, is now rarely present? Can the FSIS rely more heavily on the robust E. coli O157:H7 testing already being done by industry?

Testing is an important part of the validation process, but as OIG concedes, “testing alone cannot suffice to ensure that consumers are safe from a pathogen like E. coli O157:H7.” It is striking that the response to Rep. DeLauro’s request to the OIG regarding N-60 testing was expedited, but the industry’s petition to the FSIS for carcass irradiation has gone unanswered (Despite Safety Benefits, FSIS Delays Approval Of New Food Safety Technology).

Over five years ago, the American Meat Institute (“AMI”) submitted a petition to the FSIS to approve the use of carcass e-beam irradiation technology in meat plants. AMI requested that the petition be granted so that low levels of irradiation could be applied to the surface of chilled beef carcasses as a food safety processing aid. The use of this technology has proven to be an effective measure in reducing the presence of pathogens in raw meat products.

Carcass irradiation is an intervention that could immediately increase the safety of our food. We implore the FSIS to approve carcass irradiation without any further delay.
 

Despite Safety Benefits, FSIS Delays Approval Of New Food Safety Technology

Although most people believe that the decision to develop and utilize ground-breaking food safety technology rests exclusively in the hands of industry, this view is often mistaken.

Rather, the use of most new interventions that could immediately increase the safety of our food depends, not upon industry, but upon the approval of the federal government. And, when federal officials refuse or fail to act, both industry and consumers can suffer.

In 2004, the American Meat Institute (AMI) submitted a petition to FSIS to approve the use of carcass e-beam irradiation technology in meat plants. AMI requested that the petition be granted so that low levels of irradiation could be applied to the surface of chilled beef carcasses as a food safety processing aid. The use of such technology has proven to be an effective measure in reducing the presence of pathogens in raw meat products.

And yet, despite the obvious food safety advantages, the agency has for five years refused to approve use of the technology. To the surprise of many, agency officials announced in a recent meeting with the North American Meat Processors Association (NAMP) that no decision would be forthcoming soon.

Presumably, the reason carcass irradiation is an issue with FSIS is because AMI requested that it be approved as a “processing aid.” If the request was granted, processors would be allowed to use the technology without having to place special labels on meat processed with the intervention. Without specifying what, exactly, it was referring to, however, the FSIS stated simply that, “because of other recent events, processing aids in general are under greater scrutiny right now."

Although all of this may be true, with an increasing ability to detect food-borne illnesses and outbreaks nationally, the overall safety of food is under greater scrutiny as well.

In any event, carcass irradiation has often been cited by the meat industry as viable way forward in the fight against E. coli O157:H7 in ground beef. Keeping the word "irradiation" off labels, or even changing its description to something like "pasteurization," have been suggested as ways to increase public acceptance. This is because, previously, the use of low levels of irradiation to treat finished ground beef products fell flat, in large part, because the USDA required the use of a radura symbol on ground beef labels which simply scared the public away.

Frustrated by the lack of progress on its long-standing request, the AMI recently sent a letter to FSIS officials urging them to take action on the outstanding petition. FSIS then responded by saying the issue was being held up because it was waiting for the AMI to answer some of its queries on the petition. AMI, however, reported that it had never received any questions or concerns from the agency.

The controversy intensified last week when, as noted, FSIS informed NAMP of its intent not to grant the petition. When FSIS was asked to provide additional details regarding the continuing delay, it again stated that “AMI [still] needs to provide answers to [FSIS’] questions in order for FSIS to be able to act further on the petition.” Once again, however, the meat association denied being contacted by the FSIS, stating it had “received no formal response to [the] petition, including any questions or concerns that FSIS may have”.

AMI executive vice president James Hodges stated further that there was no reason to continue delaying evaluation of the matter. “AMI has submitted all information needed for FSIS to . . . publish a proposed rule regarding treating carcass surface irradiation as a processing aid”, he said. “Questions or issues about the technology [can be] best addressed through the rulemaking process that will be required to establish the parameters regarding applying this proven food safety technology. We look forward to a favourable response from FSIS.”

Having defended well-intentioned food companies for nearly ten years, and having witnessed the onslaught industry has received recently from media and congress for “failing to do more,” I am perplexed at the lack of urgency displayed by the agency. Perhaps this is yet another example of how government, rather than solving our problems, can often make them worse.

Thus, we too urge FSIS to take action on AMI’s proposal. If we truly want to advance food safety, we should start by convincing our government to advance those technologies that make it possible.