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

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

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

Defending High-Profile Food-Borne Illness Outbreaks And Claims

Given recent improvements in national food-borne illness outbreak surveillance, more food-borne illnesses are being identified, and more outbreaks are being reported.

By extension, many of these outbreaks are being associated with an increasing number of foods, and more companies are – either directly or indirectly – being affected.

For nearly a decade, we have been defending food companies across the country in high-profile outbreak litigation (involving meritorious and non-meritorious allegations). During this period, we have also learned first-hand that when outbreaks do occur, not all investigations are performed properly, and not all resulting claims have merit.

Because of limited resources and other reasons, many outbreak investigations are still unable to identify the real culprit, and some continue to identify the wrong source. Unfortunately, in these and other cases,  many claimants (and their attorneys) continue to sue the wrong party.

Thus, when a food company is faced with an outbreak, it is critical to obtain experienced counsel counsel: (1) who understand how food-borne illnesses are tracked, investigated and confirmed; (2) who can help challenge developing assumptions and conclusions regarding potential source; (3) who can effectively respond to regulators and media during an outbreak and recall; and (4) who know how to properly defend food-borne illness claims and lawsuits when they do, indeed, occur. Over the last 10 years, our firm has written the doctrine on Defending Food-Borne Illness Outbreaks And Claims.

Although we enjoy one of the most plentiful, affordable and safest food supplies in the world, we also live in one of the most litigious societies. Thus, despite the fact that food-borne pathogens are (and likely always will be) an inherent part of our food supply, and despite the fact that individual risk can be greatly reduced through responsible consumer behavior, many individuals will continue to be affected by food-borne illness and, unfortunately, regardless of source or cause, many will continue to sue.

In recognition of your incredible efforts to provide safe and plentiful food to our families, we are proud, when lawsuits are threatened, to protect and defend yours.

Elisabeth Hagen Selected To Become Under Secretary For Food Safety

Dr. Elisabeth Hagen has been selected to become the USDA’s newest Under Secretary for Food Safety. If confirmed, Hagen will serve with Agriculture Secretary Tom Vilsack.

"There is no more fundamental function of government than protecting consumers from harm, which is why food safety is one of USDA's top priorities," said Vilsack. " Dr. Hagen brings the background, skills, and vision to lead USDA's efforts to make sure that Americans have access to a safe and healthy food supply."

The Food Safety mission of USDA includes the Food Safety and Inspection Service (FSIS), which is the public health agency in the USDA responsible for ensuring that the nation's commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged.

Dr. Elisabeth Hagen currently serves as the USDA's Chief Medical Officer, serving as an advisor to USDA mission areas on a wide range of human health issues. Prior to her current post, she was a senior executive at FSIS, where she played a key role in developing and executing the agency's scientific and public health agendas. She has been instrumental in building relationships and fostering coordination with food safety and public health partners at the federal, state, and local level.

Before joining the federal government in 2006, Hagen taught and practiced medicine in both the private and academic sectors, most recently in Washington, DC. She holds an M.D. from Harvard Medical School, and a B.S. from Saint Joseph's University. Dr. Hagen completed her specialty medical training at the University of Texas Southwestern and the University of Pennsylvania, and is board certified in infectious disease. She is married and lives with her husband and two young children in Northern Virginia.

Nationwide Salmonella Concerns Trigger Precautionary Sausage Recall

According to the USDA, Daniele International (with operations in Pascoag and Mapleville, Rhode Island) has announced a voluntary and precautionary recall of approximately 1,200,000 pounds of sausage products which had been distributed nationwide.

The recall was announced as a precautionary matter, during the course of an ongoing CDC investigation into the source of a Salmonella Montevideo outbreak which has sickened hundreds in over 40 states.

Based upon analysis of preliminary epidemiological data, the CDC and FSIS believed there was a possible association between limited numbers of these illnesses and the consumption of certain sausage products. Some illnesses, however, showed no connection to Daniels or the products it processed. Nevertheless, although the investigation is ongoing, the CDC has posted information about the multi-state outbreak on its website. Click on the following link to view the most recent CDC Outbreak Report.

Because of speculation that the potential source of the salmonella in sausage products may be linked to contaminated pepper, the company elected to recall all products which may be potentially affected. Click on the following link to view the FSIS Recall Release. As the investigation continues, Daniels is working closely with state and federal agencies to help determine the most likely source.

JANUARY 31, 2010 UPDATE:

As the investigation continues into the source of the national Salmonella Montevideo outbreak, Daniels has announced an expansion of its original January 23, 2010 recall. The expanded recall, involving approximately an additional 17,000 pounds of sausage products, was announced after the finding of Salmonella in certain samples of sausage not included in the original recall. Click on the following link to view the January 31, 2010 FSIS Recall Release.

FEBRUARY 4, 2010 UPDATE:

As the investigation continues into the source of the national Salmonella Montevideo outbreak, Daniels announced a second expansion of its ongoing recall. The expanded recall, involving approximately an additional 23,000 pounds of sausage products. Click on the following link to view the February 4, 2010 FSIS Recall Update. FSIS has also published a list of all the retail locations to which these products were distributed and sold. Click on the following link to view the FSIS Retail List.

According to the CDC, the outbreak currently involves over 200 people from 41 states. Ove these, approximately 42 people have been hospitalized, and no deaths have been reported. As noted above, however, some individuals have reported no exposure to Daniels or any of its products. For this reason, the CDC, FSIS, countless state and local health officials, as well as Daniels representatives, are continuing to work tirelessly to determine the most likely original source of the contamination. Click on the following link to view the most recent CDC Outbreak Report.

We, of course, wish them luck in their continuing endeavors.

Mike Taylor Appointed To New Food Safety Post

When I recently stood in for Mike Taylor as Keynote Speaker at the National Center for Food Safety and Technology annual meeting, I had no idea he would soon become the new Deputy Commissioner for Foods. The FDA created the new position, along with the Office of Foods, in August 2009.

As Deputy Commissioner for Foods, Taylor will help the FDA develop and implement a prevention-based strategy for food safety, plan implementation of new food safety legislation, and help ensure that food labels contain clear and accurate information on nutrition.

Taylor began his career as a staff attorney at FDA, holding various positions including deputy commissioner for policy. Taylor later served as administrator of the Food Safety and Inspection Service and acting under secretary for food safety at USDA. During his tenure, he initiated many reforms, including the development of comprehensive HACCP rules for meat and poultry processors and, through a policy statement, declaring E. coli O157:H7 an adulterant in ground beef.

Prior to becoming a senior FDA advisor in 2009, he served as a research professor at the School of Public Health and Health Services at George Washington University.

E. Coli Concerns Prompt Ground Beef Recall

According to the USDA, Huntington Meat Packing (of Montebello, California) has announced a voluntary and precautionary recall of approximately 864,000 pounds of ground beef products.

The following products, produced between February 19, 2008 and May 15, 2008, and January 5, 2010 and January 15, 2010, are subject to the recall:

  • 40 lb. boxes of "Huntington Meats Ground Beef"
  • 40 lb. boxes of "HUNTINGTON MEAT PKG. INC. BEEF GROUND FOR FURTHER PROCESSING"
  • 40 lb. boxes of "BEEF BURRITO FILLING MIX"
  • 10 lb. boxes of "IMPERIAL MEAT CO. GROUND BEEF PATTY"
  • 20 lb. boxes of "IMPERIAL MEAT CO. GROUND BEEF PATTY"
  • 10 lb. boxes of "El Rancho MEAT & PROVISION ALL BEEF PATTIES"

Each box bears the establishment number "EST. 17967" inside the USDA mark of inspection on the label. The products were shipped to distribution centers, restaurants, and hotels within the State of California. Click on the following link to view the FSIS Recall Release.

The problem was discovered during a Food Safety Assessment (FSA) by FSIS personnel. During a review of the establishment's records, FSIS determined that these products could potentially be contaminated with E. coli O157:H7. While these products are normally used fresh, the establishment announced a broader recall because of the possibility that some products could still be frozen and in commerce. Media and consumer questions regarding the recall should be directed to the company owner, Robert Glenn, at (888) 894-8242.

To date, there have been no reported illnesses associated with the consumption of these products. FSIS also reminds consumers that thoroughly cooking raw beef products to an internal temperature of 160 degrees will destroy any pathogens that may be present, and will render the products safe.

Listeria Concerns Prompt Recall Of Numerous Peanut Butter, Cheese, Salsa And Other Products

According to the FDA, Parkers Farm, Inc. (of Coon Rapids, Minnesota) has announced an expanded recall of various peanut butter, cheese and salsa and other products, to include all date codes, because they have the potential to be contaminated with listeria monocytogenes.

The recall, originally announced January 8, 2010, affected product with sell by dates of specific ranges. The expanded recall now includes all products and all sell by dates.

The recalled products were distributed nationwide in the following retail stores: Hy-Vee, Cub, Rainbow, Byerlys, Lunds, Target, Whole Foods, Jewel, Dominicks, Marsh, Price Chopper, Shop Rite, Nash Finch, Sams Club, Costco, Safeway, Kroger, Wal-Mart, Aldi. Click on the following link to view the FDA Recall Release and list of affected products.

The recall was a result of a sampling done by the state of Wisconsin and the state of Minnesota which revealed that some finished products contained the bacteria. The state of Minnesota, FDA, and the company continue their investigation into what, exactly, caused this potential problem.

It is also important to note that, to date, no illnesses have been reported in connection with the consumption of these products. Nevertheless, the company is urging consumers who may have purchased these products to return them to the place of purchase. Consumers with questions can also contact the company at (800) 869-6685.

USDA Announces New E. coli O157:H7 Vaccines

The USDA's Agricultural Research Service (“ARS”) has announced that its scientists have developed two vaccines that might reduce the spread of E. coli O157:H7 in cattle.

"Preventing E. coli O157:H7 from proliferating inside cattle helps limit contamination of meat at the packinghouse, and reduces shedding of the microbe," ARS said in a statement. "Manure-borne E. coli can sometimes be moved by rainfall into drinking water. What's more, in some instances, it can end up in irrigation water, and can potentially contaminate fruits, vegetables and other crops, increasing risk of an outbreak of food-borne illness."

The first form of the vaccine is comprised of cells of a strain of E. coli O157:H7 that lacks a gene called hha. A second form of the vaccine contains an E. coli strain that lacks both hha and a second gene, sepB. In each of the vaccines the E. coli strain produces immunogenic proteins, which trigger an immune system response that prevents E. coli O157:H7 from successfully colonizing in cattle intestines.

In preliminary tests, 3-month-old Holstein calves were immunized with a placebo or either form of the vaccine. Six weeks later, the animals received a dose of E. coli O157:H7 and for the next 18 days, their manure was tested for evidence of the microbe. Calves that received either vaccine had reduced or non-detectable levels of E. coli within only a few days after being inoculated with the bacteria.

Research microbiologists Vijay K. Sharma and Thomas A. Casey developed the vaccines in their laboratories at the agency's National Animal Disease Center in Ames, Iowa.

Volunteering For A Recall

By Guest Blogger Cathy Crawford

The proposed regulations which are part of the Food Safety Modernization Act include provisions for mandatory recalls. While in rare cases, such provisions could potentially be helpful where a company is reluctant to conduct a recall, the vast majority of recalls are not only voluntary and effective, but often go above and beyond what may soon be defined as “requirements.”

Consider, for instance, the recent recall of various canned Slim-Fast products. Unilever should be commended for its voluntary and precautionary actions. In this regard, it is critical to note that there were no illnesses associated with the consumption of these products. Rather, a potential food safety issue was identified internally by the company and then immediately reported. Thus, this is not a case that demonstrates the importance of, or need for, additional government oversight. Rather, this was a responsible company which, on its own accord, accepted the need to react, and did react, proactively to address possible food safety concerns.

Next, and even more important, is the size of the recall. Large recalls sometimes lead the media and consumers to believe that our great American food supply is unsafe. This recall, however, demonstrates just the opposite. For Unilever, it was likely that the exact cause of the potential problem was not immediately understood. Nevertheless, all of the potentially affected products involved in the recall were simply assumed by the company to be possibly – not factually – contaminated. In truth, there may have been one contaminated container, none, or many. Because the company wanted to react quickly, however, it initiated a very expansive recall, hoping the public would respect its actions, rather than judging it for having produced a suspect product.

Often, the behind the scenes, certain data driving the scope and limits of a recall are not fully available to the public. In turn, what consumers see or believe is only that a company released a food product later subject to a recall, and then had to have it returned so it could be safely discarded. What is rarely explained is that most of the food involved in any recall is completely safe. Because it can’t quickly be "proven" to be either safe or unsafe, however, it is voluntarily recalled, in an abundance of caution, to remove all potential risk.

If, or more likely when, recalls become “mandatory,” most companies will of course strive to comply with those requirements imposed by the relevant federal agencies. In doing so, however, some companies may become dependent upon federal regulators to define the scope of a recall, and thus overlook the opportunity to do more than what is being strictly required. Thus, although we may see routine compliance, we may also witness a potential loss in some of the extraordinary efforts taken by companies when they themselves voluntarily define the scope of a recall and go the extra mile in the name of public confidence and food safety.

Thus, in my view, additional and pointed regulatory power in such circumstances may not be the best answer. Instead, a coordinated effort to increase and enhance industry education may be a better long term solution. Imagine, for instance, the difference of having careful drivers in a school zone where the community uses education and training to instill an authentic sense of care about driving near schools. Compare this to a place where the time allotted for drivers’ education courses has been reduced, but drivers are expected to travel at 25 mph only because it is mandatory. In the end, which environment is safer? In which case are drivers likely to push the limit farther, and drive a bit faster, when no one is looking?

I would rather see additional resources diverted to increased awarness and training than simply trying to legislate a quick solution to a perceived problem by empowering and then expecting regulators to both define and then require “mandatory recalls.” Remember the drivers’ educational videos that may have scared you and convinced you of the power in your hands when at the wheel? Perhaps something similar, along with increased annual Hazard Analysis and Critical Control Point (“HACCP”) and food safety training, would do more for our system than additional legislation.

The food safety systems in many companies include HACCP protocols as well as systems in compliance with globally accepted food safety standards such as the Safe Quality Foods (SQF) or the British Retail Consortium (BRC). There are times when these systems might fail to identify or prevent a hazard. In these cases, however, responsible companies most often act proactively and quickly to implement corrective actions. Those actions include protecting the public, finding the cause of the problem, eliminating that cause, and updating internal systems to ensure any changes are effective. These things don’t happen without training. No legislation can replace that.

Nevertheless, a mandatory recall provision will likely pass. Without robust and effective food safety training at all stages in the food chain, however, this by itself will not likely diminish the need for recalls, nor will future recalls become any more efficient or effective.

* Cathy Crawford serves as a consultant with the HACCP Consulting Group (HCG), based in Fairfax, VA, just outside of Washington, DC.

HCG provides food safety consulting services to the food industry. Founded in 1994, HCG offers food safety training and assistance to both the FSIS and FDA regulated food industry as well as in over 35 countries that export meat and/or poultry to the U.S. Five of HCG’s 10 partners are former FSIS officials with the others from the food industry and state inspection programs. We have basic and advanced HACCP training courses accredited by the International HACCP Alliance in College Station, TX. HCG also provides Serve Safe training to the restaurant industry and has provided food safety training at a well know Culinary Institute. For more information about HCG please visit HCG’s web site at www.haccpcg.com.

USDA Launches Toll-Free Help Line For Small Processors

The USDA’s Food Safety and Inspection Service (“FSIS”) has announced the creation of a new help-desk, providing operators of small meat, poultry and egg processing establishments with access to knowledgeable specialists who can help them understand USDA directives, regulations and other information. The help-desk also will provide direct assistance to state and local food regulatory agencies.

"The FSIS is committed to providing assistance to businesses of all sizes that provide American consumers with access to a safe and healthy food supply," said Deputy Under Secretary for Food Safety Jerold R. Mande. "The small plant help-desk will help the development of small, local producers by offering a one-stop shop for questions about how to make sure their meat, poultry and processed egg products are safe, wholesome and properly labeled."

The new help-desk will support USDA's "Know Your Farmer, Know Your Food" initiative by helping small processors to reduce the time and expense of dealing with agency requirements. "Know Your Farmer, Know Your Food" is designed to continue the national conversation about developing local and regional food systems and finding ways to support small and mid-sized producers. It emphasizes the need for a fundamental and critical reconnection between producers and consumers, building on the 2008 Farm Bill, which provides additional flexibility for USDA programs to promote local foods. More information on the "Know Your Farmer, Know Your Food" initiative can be found at: www.usda.gov/knowyourfarmer.

The FSIS small plant help-desk will serve as a "one-stop shop" for plant owners and operators with questions. More than 90% of the 6,000 plants inspected by FSIS are small or very small. FSIS staff will assess callers' requests and provide information and guidance materials that best meet their needs. In situations where the answer is not readily available, the staff will research the issue and follow-up with the caller. As appropriate, the help-desk will provide a portal to other services, such as AskFSIS, FSIS' existing service offering agency responses to inquiries on agency policy.

Inquiries can be made to the small plant help-desk by toll-free telephone or by email. The help-desk is open from 8:00 a.m. - 4:00 p.m. EST, Monday through Friday, excluding Federal holidays. To speak to a staff specialist during this time, call 1-877-FSISHelp (1-877-374-7435). You may also contact the help-desk by email at InfoSource@fsis.usda.gov.