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In our last column, I discussed how current FSIS policy (which invariably reacts critically to any positive testing results) discourages companies from aggressively testing to find pathogens in their products.

When adulterants are found in ground beef products, the results must be shared with FSIS and determinations made regarding which products are potentially affected and how they will be disposed. Unfortunately, in many instances, FSIS will use a company’s positive findings as a catalyst to aggressively and sometimes unreasonably second-guess its actions and response. 

This costly and unwarranted burden has, in many cases, discouraged the development and creation of truly effective testing programs by industry.

Now, FSIS is in the process of reviewing a petition from the Center for Science in the Public Interest which asks the agency to declare numerous strains of Salmonella as adulterants in raw meat and poultry.

The agency’s response to recent questions on this issue suggests that FSIS is seriously considering the policy. Dan Engeljohn, assistant administrator FSIS’s Office of Policy & Program Development, recently told attendees at an annual meat industry conference that FSIS is currently “assessing [the policy], and how we’d go forward if we were to adopt it.”

This sounds to me like the decision has already been made.

As FSIS considers it next steps, however, it needs to maintain a reasoned approach which recognizes the fact that it is currently impossible, given current technology, to completely eradicate ubiquitous organisms from raw beef and poultry products.  For this reason, whatever policy FSIS develops, the agency should at the same time reassess how it will react and respond to processors who aggressively test to find Salmonella (or other pathogens) in their products.

From my experience, the majority of beef processors would welcome additional controls aimed at reducing the numbers and levels of pathogens in incoming raw trim used to process hamburger.  If, however, the agency continues to penalize (rather congratulate) processors who test for and then find these pathogens in their finished products, then our food supply will not likely become any more safe.

Thus, in my view, as FSIS considers its policy going forward, the agency should also recognize that it has an unparalleled opportunity to develop and embrace rules that adequately enforce the new standards at slaughter, but also encourage (rather than discourage) additional testing.  If FSIS can incentivize the creation of new cutting-edge programs designed to find pathogens in products before they reach consumers, as opposed to destroying any incentive to test and find (through its often oppressive reaction when pathogens are found), then the agency will have substantially advanced the calling of food safety. 

So, as we wait with interest to see whether FSIS will declare Salmonella as an adulterant, we also wait to see if FSIS will continue to unfairly (and, in my view, improperly) test the tester.

** This article, authored by Shawn K. Stevens, is also featured in the April edition of the National Provisioner.

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Microbiological sampling can be an effective tool to help companies verify that their interventions are working. But how much testing is really expedient given the current food safety climate?

Today, many companies are testing for Listeria, Salmonella, E. coli O157:H7, generic E. coli, various other indicator organisms and, now, six additional STECs. Many companies perform raw material sampling, environmental sampling, equipment sampling and finished product sampling.

Even so, some argue, it is still not enough.

Unfortunately, not even companies on the cutting edge of food safety, who have implemented state of the art testing programs which far exceed FSIS requirements, are immune from outbreaks, recalls and criticism. This is because testing can never provide a one hundred percent guarantee that a product is sterile. Contamination in foods is by nature quite sporadic and, thus, difficult to detect.

Although finished ground beef product testing is not mandated by federal law, many companies nevertheless embrace finished product testing as a means to better monitor their processes and to further enhance the safety of their products. These companies not only deserve our commendation, but they also deserve to be treated better by USDA.

This is because current USDA policy discourages companies from finding pathogens in their products. When E. coli O157:H7 is found, the results must be reported to USDA, and determinations made regarding which products are potentially affected and how they will be disposed. Unfortunately, in many instances, USDA will use a company’s positive findings as a catalyst to aggressively second-guess its actions and response.

Indeed, rather than allowing processors who test and find to quickly address those findings and divert affected product, the agency too often responds with additional regulatory intrusion and unwarranted criticism. Moreover, the more companies test, and the more they find, the more onerous and oppressive agency intervention can and potentially will become. Similarly, in the unfortunate event that a company (despite its best efforts) finds itself associated with an outbreak or recall, USDA is virtually certain to conclude in a Notice of Intended Enforcement issued following the recall that the companies’ testing program was somehow deficient – no matter how good the program actually was.

This reality, unfortunately, demonstrates the glaring disconnect between the science of food safety and the expectations of regulatory inspectors.

Thus, although companies that perform more testing stand a far better chance of finding contamination and reducing their risk of being associated with an outbreak or recall, they cannot reduce the risk entirely. Thus, to encourage more (not less) sampling, USDA should begin adjusting its policies to create more (not less) incentive for companies to test to find.

If we are to make further strides in food safety, we must develop science-based solutions which examine the root causes of contamination. And, USDA needs to take a closer look at how it responds to processors who aggressively test their finished products. In the end, it needs be pathogens – not companies doing the right thing – who feel they are being tested.

** This article, authored by Shawn K. Stevens, is also featured in the March edition of the National Provisioner.

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The USDA’s Food Safety and Inspection Service ("FSIS") recently announced they will extend the agency’s implementation date for non-O157:H7 STEC sampling and testing to June 4, 2012.

The extension, according to FSIS, was announced to give establishments additional time to validate their test methods and detect non-O157:H7 STECs prior to entering the stream of commerce.

As part of its zero-tolerance policy for E. coli O157:H7, FSIS will begin sampling both domestically produced and imported raw beef manufacturing trimmings and other raw ground beef components for the serogroups O26, O103, O45, O111, O121 and O145.

In a statement, AMI Executive Vice President Jim Hodges applauded the temporary delay, but argued again that additional research is still needed given the significant shift in agency policy.

“Even with a 90 day delay, imposing this new regulatory program in June puts the cart before the horse and will needlessly cost tens of millions of federal and industry dollars – costs that likely will be borne by taxpayers and consumers. In short, the policy is not likely to yield a significant public health benefit and given that research should precede and dictate the policy, the process that FSIS has followed in this matter is no way to develop good public policy.”

In the end, significant questions still exist regarding the prevalence and virulence of non-O157:H7 STECs in beef products. Time will tell whether the substantial resources being directed toward these new pathogens will, indeed, translate into a substantial improvement in public health.

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Government health agencies have come under fire in recent days for the manner in which they conducted a recent foodborne illness investigation.

The CDC, in the final report of the outbreak, was criticized for referring only to a “Chain A” when describing a company that likely had been supplied with contaminated product, likely produce. The outbreak, and any possible attendant risk to public health, had ended by the time the report was published. The CDC determined that the contamination likely occurred before the product ever reached the restaurants.

Investigative efforts were unable to identify a specific food associated with illness, but data indicate that contamination likely occurred before the product reached Restaurant Chain A locations.

This outbreak now appears to be over.

Despite the reported unlikelihood of any possible additional risk, many are accusing the CDC of jeopardizing the public health by not identifying “Chain A.”

A Seattle-based plaintiffs’ food safety attorney has been leading the charge against the unnamed company, the FDA and the CDC. His complaints stem from CDC’s decision not to disclose the identity of the restaurant chain. It is his contention that “the public has a right to know and to use the information as it sees fit, and people – especially government employees – have no right to decide what we should and should not know.”

CDC’s policy, according to Robert Tauxe, is to disclose the identity of an outbreak source “only when people can use that information to take specific action to protect their health." While some decry the policy, it is in place to promote cooperation between governmental health agencies and companies that may be associated with illnesses.

On the one hand, cooperation between agencies and business during the course of an outbreak is critical. The most important thing, I think we can all agree, is to protect public health in the event of an ongoing outbreak. In the event that public health is at risk, CDC and FDA release the names of companies and the potentially implicated products.
Without cooperation, however, CDC investigators worry that it will take longer to identify the source of outbreaks, potentially resulting in unnecessary illnesses. Thus, if an outbreak is over, current policy is not to name the offending company. Often, as in this case, it is a supplier who provided the contaminated product and not the restaurant itself.

In the end, CDC is not interested in blaming or punishing. Their job is to protect the public from health hazards and they feel they can better accomplish that by not revealing the names of companies who received contaminated products.

Others, however, take the position that it is a consumer’s right to know if a restaurant is associated with an outbreak, even after it is over. They argue that, when it comes to public health, it is not for the government to decide what information people should and should not have access to.

In the case of the outbreak at issue, the investigation revealed:

Collaborative investigative efforts of state, local, and federal public health agencies indicated that eating food from a Mexican-style fast food restaurant chain, Restaurant Chain A, was associated with some illnesses.

CDC and FDA do the best they can with the resources they have. Their investigation showed a statistical association between the outbreak and the restaurant chain. The restaurant chain, in turn, did all it could to assist the CDC in determining the root source. This cooperation is reflected in the CDC report:

Restaurant Chain A, as well as their food suppliers and distributors, were very cooperative in providing extensive information to public health officials as various leads were explored.

Unfortunately, notwithstanding its best efforts, the CDC was unable to trace the illnesses back to a single product. Tracing microscopic bacteria to a single source can in some cases be very challenging. But to accuse the CDC of colluding to make people sick because it didn’t reveal the name of a company that may itself have been a victim of the outbreak is inappropriate.

Both the restaurant chain and the agencies involved in investigating the outbreak deserve to be praised for their cooperation in trying to determine the source of this outbreak. The chain at issue did not contaminate the food, it arrived that way. As such, there is absolutely no reason to openly criticize the company, especially in light of its own efforts to help CDC and FDA prevent further illness.

Here is a link to the CDC report: I think it is actually rather impressive.

http://www.cdc.gov/salmonella/restaurant-enteriditis/011912/index.html

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On January 4, 2011, President Obama signed the Food Safety Modernization Act ("FSMA").

Since the FSMA was signed into law, the FDA has made significant progress in a number of areas. Although not all of the changes expected under the FSMA have gone into effect, many of the changes have already been implemented.  In the past year, for instance, the agency has implemented the following initiatives quickly and with minimal confusion:

• Consumer-Friendly Web Search for Recalls. FDA launched a more consumer-friendly recall search engine on the FDA website.

• Guidance to Seafood Industry on Food Safety Hazards. FDA issued its updated guide to the seafood industry on hazards associated with fish and fishery products and appropriate controls for those hazards.

• Administrative Detention of Foods. Allows FDA to administratively detain food products that it has reason to believe are adulterated or misbranded for up to 30 days, if needed. FDA has begun using this authority.

• Prior Notice of Imported Food. FDA issued an interim final rule that requires a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry.

• Joint Anti-Smuggling Strategy. FDA and the Department of Homeland Security issued a joint anti-smuggling strategy to help to identify and prevent smuggled foods from entering the U.S. and posing a threat to national security and consumer safety.

• Fee Schedule. FDA announced the fiscal year 2012 fee schedule for certain domestic and foreign facility re-inspections and for failure to comply with recall orders.

• Authority to Suspend the Registration of Food Facilities. FDA has the authority to suspend the registration of food facilities to prevent the import and export into the U.S. in certain circumstances involving food that has a reasonable probability of causing serious adverse health consequences or death to humans or animals.

• Product Tracing Pilots Launched. FDA announced that the Institute of Food Technologists (IFT) will carry out two new pilot projects aimed at enhancing the agency’s and industry’s ability to trace products responsible for foodborne illness outbreaks.
   

Reportedly, the FDA has also met the FSMA mandate for foreign inspections. For domestic inspections, the FSMA mandate is based on a 5-year time period.

In the past year, FDA has defined its high-risk and non-high-risk domestic food facility inventories and in FY11, FDA and various state partners conducted more than 20,000 food facility inspections. At this rate the Agency will likely meet the domestic food inspection frequency mandates contained within FSMA. In addition, FDA is developing new risk-based approaches to domestic inspection to maximize public health benefit.

Communication and outreach have also played an important role as FDA implements the various FSMA provisions.

• FDA has participated in more than 350 meetings with industry leaders, farmers, consumers, public officials, and academics.

• On produce safety, FDA has worked very closely with USDA, which has an established relationship with farmers, and taken part in 14 farm tours across the country to gather input on how the proposed rules can work feasibly across the diversity of commodities and growing conditions and practices.

• FDA, the US Department of Agriculture, and the National Institute of Food and Agriculture entered into an agreement to collaborate on the establishment of a competitive grant program for food safety training and other projects.

• FDA held three public meetings on preventive controls, import provisions, and changes to inspection and compliance programs in a preventive controls environment.
• FDA has participated in more than 70 meetings globally to discuss the international impact of FSMA. This includes trips by the Deputy Commissioner for Foods to China, Mexico, Canada and the European Union.

• FDA participated in, and helped fund, the establishment of the Produce Safety Alliance and the Food Safety Preventive Controls Alliance to help industry, especially small and very small firms, to comply with the requirements.

• FDA provided information to the business community through the extension services of 49 land-grant colleges and universities.

• FDA established a FSMA webpage that now has more than 10,000 subscribers, includes more than 100 Frequently Asked Questions by topic, and features videos, webinars, presentations, and print materials.

While the impact of many of the changes implemented by FDA to date have been relatively minor, some of the most comprehensive regulatory changes – such as the requirement that food companies adopt written food safety plans – are still to come. We, of course, continue wait in earnest to see, exactly, what the agency has in store.

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With the passage of the Food Safety Modernization Act (FSMA), FDA has been tasked to cultivate approximately 50 new rules, guidance documents, reports and studies – all of which all must be implemented within very specific timeframes.

In turn, while many of the new provisions have yet to be implemented, numerous milestones (despite popular belief) have already been met. These milestones have also, at least in part, touched upon many of the most significant changes under the new law, including increased agency authority, new requirements for preventative controls and new import standards and expectations. Although many of these topics (along with additional anticipated developments still lurking just over the horizon) will be discussed in greater detail in our next issue, we wanted to provide a quick primer of both where we’ve been and how much further we still need to go.

Notably, FDA’s implementation of the FSMA first started gaining real momentum three months after passage (in March 2011), when FDA hosted a public meeting focused on the legislation’s new import safety requirements. The meeting attracted more than 500 attendees and, although many topics were discussed, the debate focused mainly on four key import safety provisions: Accredited Third-Party Certification; Import Certifications of Food; the Voluntary Qualified Importer Program; and the Foreign Supplier Verification Program. In essence, these new initiatives will require food product importers to ensure that each of their foreign suppliers are following the same standards that are and will be expected of food processors here in the U.S.

It became clear from the meeting, however, that setting such standards, and then ensuring compliance, will create significant challenges. The amount of food that is imported into the United States has been steadily and rapidly increasing for years. This is especially true with high risk foods like fruits, vegetables and seafood. In turn, much of the food imported annually originates from countries (and economies) without the resources or infrastructure to develop and implement the robust food safety programs which are taken for granted here in the United States.

Nevertheless, the FDA has announced that it will expect those U.S. food companies who chose to import, process or sell foreign products to ensure not only the safety of the products themselves, but to also ensure that their foreign suppliers are complying with each of the regulatory requirements under the FSMA. These requirements, for instance, will mandate that each foreign supplier implement a written food safety plan that satisfies the requirements of FDA.

In the weeks following the March 2011 import safety meeting, FDA then began focusing additional effort on widening it regulatory powers here at home. On May 5, 2011, FDA issued a new rule allowing it to administratively detain foods which the agency has reason to believe may be adulterated or misbranded. The new rule went into effect on July 2, 2011.

Effective the following day, on July 3, 2011, the FDA then gave itself additional authority, which allows the agency to suspend the registration of regulated U.S. food facilities. This new power gives FDA the ability to suspend (or threaten to suspend) the registration of any regulated food facility if the facility is producing food which, in the judgment of the agency, presents a reasonable probability of causing serious adverse health consequences or death.

Since July, the agency has been moving forward on other fronts as well. With the assistance of the Department of Health and Human Services (HHS), FDA has also begun to develop and implement a joint-anti smuggling strategy to identify and prevent smuggled foods from reaching the United States. HHS and FDA report that they will be partnering with the Department of Homeland Security and the U.S. Customs and Border Patrol to implement multi-phase strategies and technologies to counter existing and emerging smuggling threats. The threat of smuggled food, of course, extends all the way from consumer safety to national security and terrorism.

And, as many of you know, the FDA was also accepting public comment – through last August – on the docket for “Preventive Controls for Registered Human Food and Animal Food/Feed Facilities.” According to FDA, the comments received will be used by the agency to help shape the new regulations which will mandate that all regulated food facilities implement written food safety plans no later than July 2012. While many industry groups have taken advantage of the opportunity to share their perspectives with FDA, substantial uncertainty continues to exist with regard to not only what the new standards will specifically say, but how they will be uniformly and fairly enforced across the vast array of differing food processing operations across the country.

In this regard, despite the agency’ progress on many fronts, virtually all regulated food companies continue to wonder what is going to be asked of them and when. Although we have talked generally in previous articles about approaching deadlines and anticipated expectations, it will remain difficult for any food company to effectively prepare for the new anticipated regulatory changes until FDA actually publishes the new requirements.

Additionally, in the absence of any clear direction yet from FDA regarding what, specifically, the new regulations with say, many small and medium-sized companies remain worried about their long-term survival. Given the unprecedented increase in new FDA regulation triggered under the FSMA, many small businesses (some already struggling as a result of the lethargic economy) are fearful that the investments which will be required to ensure compliance could ultimately impact their ability to compete and potentially lead to financial collapse.

Indeed, Kathy Means, Vice President of Government Relations and Public Affairs at the Produce Manufacturer’s Association, recently echoed such fears, warning that while “[e]very business must have a food safety plan, these plans should be adaptable and not burdensome to small businesses.” After all, Means concluded, “the reality is that pathogens simply do not respect the size or type of an operation.” Thus, we remain hopeful that the public comments already received by FDA from industry and key stakeholders will lead to practical standards which all companies can both efficiently and effectively implement to improve their food safety programs.

In spite of the progress already made by FDA, the implementation of effective regulations (whatever their form) remains a significant challenge. In addition to the difficulties associated with developing a single set of clear and effective standards, FDA will need significant additional funding to properly, uniformly and fairly enforce those standards. Already, FDA has expressed frustration over the contrast between Congressional expectations and the limited funding which may ultimately be allocated. The agriculture appropriations bill recently passed by the House of Representatives, for instance, would decrease funding to the FDA next year by $87 million.

With that said, the FDA, seems to recognize the breadth of changes it faces, and now has more than two dozen separate working groups focused on implementing the FSMA. And, at the end of the day, we remain confident that FDA is doing all it can, and trying to do it well.

As with any piece of monumental legislation, especially one which directly affects every consumer in our nation, FDA has wisely solicited assistance directly from the food industry in a sincere effort to make the coming changes workable for all.

In the meantime, as we are driven by FDA further down this new regulatory path, we simply hope the continuing journey remains as smooth and bump-free as possible.
 

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If there’s any doubt that the legal profession will continue to significantly impact the way we do business, I wanted to share some additional perspective. When conditions are ripe, lawyers (like pathogens) tend to multiply quickly.

Most of us recall the large west coast E. coli O157:H7 outbreak in the early 1990s, in which nearly 600 people fell ill and some lost their lives. At that time, there were few reported outbreaks, very few food safety attorneys and hardly any foodborne illness lawsuits.

Since then, we have witnessed stunning changes within the industry. Beginning in 1994, USDA required raw meat products to carry safe-handling labels. In turn, Mike Espy issued a policy statement declaring E. coli O157:H7 to be an adulterant in ground beef. In 1998, USDA solidified its zero tolerance standards (for fecal and ingesta), and required establishments to implement comprehensive HACCP plans.

Meanwhile, enhanced surveillance increased our ability to detect food-borne illnesses nationwide. The CDC created PulseNet so public health agencies could upload and compare the PFGE (DNA) patterns of pathogens isolated from ill persons nationally. From 195 PFGE patterns in the mid-1990s, the database has grown to nearly 400,000 today. Having access to such information has helped investigators determine: (1) whether reported food-borne illness cases are genetically similar; and (2) whether they may have originated from a common source.

This, of course, has also led to a recent increase in reported outbreaks and recalls. Rarely a day goes by when we don’t hear about food safety in the news. And, with increased media coverage and public awareness, many attorneys have taken notice.

While a Google search for “slip and fall attorney” yields about 125,000 returns, “food poisoning lawyer” garners nearly 500,000. The result is an ever increasing number of lawsuits, often without merit, pursued by lawyers with little or no knowledge of food safety.

Because of increasing scrutiny from regulators, the media and lawyers, fewer mistakes are also avoiding detection. Thus, we should do all we can to reduce our risk and exposure to the greatest extent possible. We should embrace a robust food safety culture, closely monitor our suppliers, continuously refine our HACCP Plans, and aggressively ensure incoming and outgoing product has been appropriately tested. We are, after all, members of an incredible industry that works tirelessly to provide our families with the safest food possible.

So, recognizing that plaintiffs’ attorneys have to eat too, we should each do our part to ensure they’re shopping for our products – and not our customers.

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There has been a lot of attention drawn to recent salmonella and listeria outbreaks, and, in turn, those pathogens themselves. In the meantime, the pathogen Campylobacter has worked itself into relative obscurity. This may seem surprising, as CDC estimates that Campylobacter associated illnesses affect as many as 845,000 Americans each year.

Campylobacter is a spiral-shaped bacteria that causes disease (Campylobacteriosis) in both humans and animals and is often found in the intestinal tracts of poultry, cattle, swine, domestic animals, and sometimes humans. The bacteria pass through feces and can also be found in untreated water. It is the leading cause of diarrheal illness in the United States (USDA).

Symptoms of infection due to the bacteria usually occur 2 to 5 days after consuming contaminated food, however, it may take as long as 10 days for symptoms to appear. This is similar to E. coli and the two are often confused for one another. The most common symptom is diarrhea which can often times be bloody. Other symptoms include fever, nausea, abdominal pain, headache, vomiting, and muscle pain. Like most FBIs, those most susceptible to contracting Campylobacteriosis are young children, elderly persons, and pregnant women.

In most instances, campylobacter infections resolve without serious illness occurring. It is important to note, however that even though complications from Campylobacter infections are rare, they can occur. The following are the most common:

• Gullian-Barre´ Syndrome (GBS): most common cause of generalized paralysis. GBS occurs when antibodies built up to fight the disease attack nerve cells.

• Reactive Arthritis: inflammation of the joints, eyes, reproductive or urinary organs.

• Appendicitis

In the event that a widespread outbreak was to occur, even statistically insignificant numbers of individuals affected by such complications could spell disaster for a company. The resulting lawsuits could easily result in millions of dollars in settlements and significant brand damage.

As with preventing all foodborne illnesses, maintaining sanitary conditions and remaining cognizant of potential hazards can make all the difference in preventing Campylobacter outbreaks. With continued awareness of harmful bacteria such as Campylobacter, and how we can prevent it from occurring in our food, we can continue to prevent serious foodborne illnesses from affecting our families and ourselves.
 

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The FDA recently announced the implementation of a fully-staffed network dedicated to rapidly responding to human and animal foodborne illness outbreaks. This group is called the Coordinated Outbreak Response and Evaluation (CORE) Network.

Kathleen F. Gensheimer, formally Maine’s state epidemiologist, will lead CORE, in the new position of Chief Medical Officer/Outbreak Director. Under the leadership of Gensheimer and the FDA, CORE will be staffed by epidemiologists, veterinarians, microbiologists, environmental health specialists and risk communications specialists.

Their primary objectives of the new group are to: (1) rapidly respond to emerging outbreaks; and (2) research past outbreaks in order to develop new preventative methods in the hopes of mitigating or preventing future outbreaks.

Gensheimer, quoted in the FDA’s press release, stated, “A real benefit of the network approach is enhancing communication and coordination with federal, state and local food safety agencies, as well as industry and consumers. Given my background at the state public health level, this is a major priority for me.”

Before CORE was created, there was no centralized staff, but rather various offices of the FDA that responded to incidents. CORE, FDA is hopeful, will provide a more in-depth process of monitoring and evaluating foodborne illness outbreaks as well as facilitating faster responses when outbreaks do occur.

The lack of coordination between the multiple governmental agencies involved in foodborne illness outbreaks has, historically, resulted in a host of problems. In some instances, these have included errors in trace back investigations conducted by local health department personnel which have prevented the true source of an outbreak from being identified.

The FDA confirms that CORE will work closely in all outbreak investigations with the Centers for Disease Control and Prevention (CDC), the U.S. Department of Agriculture (USDA), as well as public health and agriculture agencies.

“The centralized staff of the CORE Network will work closely with FDA’s field emergency response coordinators and the investigative and analytical teams in the District offices and associated laboratories,” said Dara Corrigan, associate commissioner for regulatory affairs. “Working together will help to both standardize and strengthen how we conduct foodborne outbreak activities in the field.”

Ideally, CORE will fundamentally change the manner in which foodborne illness investigations are conducted in a way that allows for faster resolutions, more effective trace back and most importantly, fewer illness.
 

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