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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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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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With the passage of any new legislation, there is bound to be a period of lengthy adjustment. When that legislation is as broad and sweeping as the Food Safety Modernization Act (“FSMA”), the period of adjustment can last for years.

In a recent column, we addressed the new federal requirement that food companies (beginning in June 2012) adopt written food safety plans, alternatively referred to as Hazard Analysis and Critical Control Point (“HACCP”) plans. While the initiative may appear relatively simple and straightforward, in practice it may prove difficult for FDA to enforce the new requirements both uniformly and fairly. Thus, we wanted to take a moment to highlight some of the momentous challenges associated with the eventual implementation of the FDA’s new food safety rules.

The concept of HACCP was jointly developed in the 1960's by Pillsbury and NASA in a project aimed at keeping astronaut's food pathogen-free. Microbiological testing, they knew, was only effective to a point. So, they collaborated on a program aimed at understanding where and how failures in food safety occur. The result was HACCP; a program designed to seek out and identify the processing points where food safety risks could be reduced to the greatest extent possible. In the 1990s, FDA mandated HAACP for sea food production, and HACCP was eventually required by FSIS in meat and poultry establishments.

The program has been largely successful in the meat industry, and has led to a pronounced reduction in the number of foodborne illnesses and outbreaks. As with any regulatory initiative, however, it requires continuous refinement as science, technology and consumer attitudes mature. In spite of HACCP’s far-reaching success in the meat industry, it is important to note that the meat industry produces a fairly limited set of distinct products. And, all beef slaughter operations, by nature of the processes used, follow relatively similar HACCP programs. The risks are finite, and can be addressed from one plant to another with identical (or at least similar) interventions. Thus, within the meat industry, establishing uniformity in enforcement and compliance, while never easy, has at least proven somewhat manageable.

The FDA on the other hand, is a whole different kettle of fish. Under the new requirements, each and every food processor will have to identify, categorize and then formally address a unique set of hazards. In other words, the HACCP program at a factory which makes frozen waffles is going to be fundamentally different than the one for a processor who makes yogurt, crackers, seasonings or egg salad sandwiches. There are tens of thousands of food processors in the U.S. making hundreds of thousands of products.

So, how will the FDA ultimately approach the development and implementation of an inspection apparatus that deals uniformly and fairly with thousands of companies producing hundreds of thousands of distinct food products? This, of course, is the million (or, perhaps, billion) dollar question. This is also a question which should be flagged and debated today, as opposed to next year when compliance (however that term is ultimately defined by FDA) will be required.

In a perfect world, FDA could simply publish guidance materials outlining a single HAACP methodology (with a single set of compliance standards) that could be applied uniformly to every manufacturing facility and food product. This, however, would prove impossible. As noted, there are simply too many different food companies producing too many dissimilar food products, and there is no such thing as a one-size-fits-all science-based HACCP program.

Additionally, even if a uniform set of compliance benchmarks could be adopted and understood by all, it remains unclear how the FDA would uniformly enforce those standards throughout its many districts. In each of the FDA’s jurisdictional districts, there will inherently be countless different inspectors each sharing different qualifications. Thus, the follow-on dilemma for FDA will be how to ensure that the cookie producer in New York is ultimately being judged by the same standards as the one in California.

That, of course, presumes that the FDA inspectors will be adequately trained in HACCP. Indeed, before the FDA can determine whether any company is in compliance (again, once this term is better defined by the agency), FDA inspectors will need to gain significant expertise in HACCP. They should, ideally, hold a degree in food science, and have a clear understanding of the risks which exist in the specific products they oversee (which, as noted, could exceed thousands if not more). As of today, however, many FDA and other public health inspectors lack the appropriate food science background. Thus, there is and will continue to be a shortfall of the qualified inspectors needed to build an inspection apparatus of the size and scope necessary to visit, even on a rotating basis, each of the food processing plants in the country.

And, that’s just here at home. In today's rapidly globalizing world, many of the food products in our nation’s grocery stores, gas stations, drug stores and specialty shops contain imported ingredients. From salt and pepper to noodles, brownies and whipped cream, the things we consume often contain ingredients from faraway places. It remains to be seen who, if anyone, will oversee these products.

Thus, it stands to reason that the FDA will have to substantially increase the number and qualifications of its inspectors, not only in the United States, but also possibly abroad, to meet the goals of the FSMA. The FDA must also recognize, however, enforcement will be complicated tremendously if the inspectors who are tasked to ensure compliance lack the basic experience and training needed to oversee a science based a system which, while appearing simple on paper, can in practice be extremely complex.

With that said, both FDA and industry have time to address many of these challenges, and I have no doubt they can do so successfully. Companies and business owners, however, need to pitch in as well.

The new legislation presents a unique opportunity for industry to partner with FDA in order to prepare for and streamline the implementation of FSMA. In advance of each pending deadline, FDA will invite industry to comment on its proposed rules and regulations. In turn, offer written suggestions, and ask the FDA to define, as precisely as possible, what its ultimate expectations will be. Companies should take maximum advantage of these opportunities, as it will be their best chance to play a role in developing the rules (and, by extension, the expectations) which will one day govern their food safety programs.

As with any large undertaking, active engagement (as well as preparation and planning) will make all the difference between success and failure. Use the time you have now to prepare for the sweeping changes which will soon be at your doorsteps. Lastly, if you do nothing else, work alongside and communicate with the FDA as these changes are instituted. How, exactly, your food safety plan is ultimately enforced may eventually be up to you.
 

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Anyone involved in the food industry has now heard about the recent passage of the Food Safety Modernization Act (“FSMA”).

Although the FSMA imposes many new and (some might argue) exotic requirements on industry, the one that will likely have the greatest impact on food companies is the mandate that they “develop and implement written food safety plans.” In turn, many companies are now asking, what does this really mean? Although none of us can be certain until the FDA begins enforcing the new laws (starting in June 2012), we can give you a pretty good sense of what to expect.

Following the passage of the FSMA, and in an attempt to keep things sounding as simple as possible, the FDA announced in its promotional materials that, moving forward, food companies will simply be required to adopt “Food Safety Plans.” But things, of course, are not always as simple as they sound. In regulatory and legal terms, this means that regulated food companies will soon be required to develop and then closely follow the Hazard Analysis and Critical Control Point (“HACCP”) methodology. 

So, what is HACCP? Well, at its most basic level, it’s a system designed to address the food safety hazards we fear most. The HACCP concept was first developed by Pillsbury in the 1960s, as a quality control program to govern the production of food for the United States space program. Under the HACCP methodology, a food processor would first identify the hazards reasonably likely to affect the safety of its food (including the introduction of chemical, physical and microbiological contamination), and then establish various critical control points where interventions could be used to prevent, reduce or control those hazards. Ultimately, HACCP was critically important for NASA as it worked to ensure that the meals its astronauts were taking into space would be as safe (and as free from unwanted contamination) as possible. 

Years later, in the early 1980s, Foster Farms (a California company) was one of the first meat processors to introduce HACCP into its own operations. Thereafter, in 1985, HACCP gained additional notoriety when the National Academy of Science recommended HACCP as a means to modernize the USDA’s meat inspection system. Eventually, in the 1990s, USDA mandated HACCP for all meat and poultry production in the United States. At about the same time, FDA mandated HACCP for all seafood production, and extended these requirements in 2001 (in response to numerous outbreaks involving unpasteurized juices) to the domestic juice industry. And, more recently, recognizing how HACCP has improved the overall safety of these products, FDA successfully petitioned to have the new FSMA extend HACCP to all other segments of the food industry. Thus, with only a few exceptions, the FDA will soon require all food companies regulated by the agency to develop and closely follow their own HACCP plans. 

In turn, according to the FDA, the underlying goal of HACCP is to prevent problems from occurring in the first instance. Although describing the HACCP methodology can be somewhat complex, food companies will generally be required to: (1) formally consider and identify all reasonably foreseeable food safety hazards; (2) develop written plans addressing each of those hazards; and (3) closely follow those plans to reduce or eliminate such hazards to the greatest extent possible.  More specifically, the underlying principles of HACCP will require regulated food companies to do the following:

1. Assess Hazards: Conduct a hazard analysis to identify reasonably foreseeable food safety hazards, and develop reasonably appropriate control measures for each;

2. Determine Critical Control Points: Identify appropriate critical control points (“CCPs”) where a control measure can be applied to prevent or reduce an identified hazard;

3. Establish Critical Limits: Define acceptable and unacceptable science-based limits for all CCPs, and use those limits to ensure the production of a consistently safe product.

4. Establish Monitoring Procedures: Monitor each CCP continuously in order to identify and immediately address any deviations from the critical limits which may occur; 

5. Establish Corrective Actions: Develop procedures to be followed in the event of a deviation, which should include an assessment of the root cause, the disposition of affected product, and a written record of any corrective actions;   

6. Establish Verification Procedures: Test and critique the HACCP plan, once designed (and periodically thereafter), to verify that the HACCP plan is working correctly;

7. Establish a Record Keeping System: Develop a system to maintain and catalog all HACCP documentation for at least 2 years, in such a form that any records can be promptly made available to the FDA if requested by the agency for inspection.

Recognizing this may be a lot to swallow, there are plenty of resources available to help companies develop their own HACCP plans. As a starting point, and although they should never be used as a substitute for a well-designed program which will withstand agency scrutiny in your specific facility, both the FDA and numerous industry associations have published basic guidance materials online (and will likely be publishing additional materials in the months to come).

In addition to these background materials, there are numerous industry consultants and lawyers who will be available to help you develop, refine and critique your HACCP plan. In this regard, all companies should strongly consider obtaining advice from a qualified expert in the field as they work to ensure compliance. This is because a company’s HACCP plan will not only need to be scientifically and legally sound, but the plan itself will, for all practical purposes, become a direct extension of in-plant federal FDA regulation. Put simply, the FDA’s new regulations will not only require that your HACCP plan be adequate, but that it also be followed precisely.

So, what IS a Food Safety Plan?  Technically speaking, it is a comprehensive science-based HACCP plan. In lay terms, however, it’s a proven system designed to address the food safety hazards we fear most.

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The Food Safety Modernization Act (“FSMA”) has now been law for more than six months. In turn, FDA issued a progress report on its implementation efforts since the FSMA was signed into law last January:

Preventive Controls:

In April, almost 500 persons participated in the agency’s public meeting seeking information on preventive controls used by industry to identify and address hazards associated with specific types of food and specific processes. FDA is actively seeking further industry comment (through August 22) on its rulemaking for preventive controls. Please click on the following links to review the docket on preventive controls and submit your comments electronically or via mail.

Imported Foods:

More than 500 persons were given the opportunity in a March public meeting to weigh in on each of the four FSMA import safety provisions: Accredited Third-Party Certification; Import Certifications of Food; Voluntary Qualified Importer Program; and Foreign Supplier Verification Program.

On May 5, 2011 FDA issued an interim final rule requiring that 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.

Food Smuggling:

On July 3, 2011 FDA issued a joint anti-smuggling strategy developed with the Department of Health and Human Services (HHS) and the Department of Homeland Security (DHS) to prevent smuggled foods from entering the United States and potentially threatening consumer safety and national security.

Registration Suspension:

Effective July 3, 2011 FDA has the power to suspend the registration of a food facility, thus ceasing operations, if it believes there is a “reasonable probability” that food from the facility could cause harm to humans or animals.

Administrative Detention of Food:

Also on July 3, 2011 the rule on criteria under which FDA may order administrative detention of food product went into effect. FSMA lowered the standard, granting FDA the power to detain food product for up to 30 days if it has “reason to believe” that a product is adulterated or misbranded and may cause harm to humans or animals. Click on the following link to review the Rule on Administrative Detention.

Seafood:

FDA issued an updated guide to the seafood industry on appropriate controls for hazards associated with fish and fishery products. Industry may employ different controls if the alternative controls satisfy the applicable statute and regulations. Click on the following link to view Seafood Hazard and Control Guidance.

Inspections and Compliance:

In June, almost 700 people participated in the agency’s public meeting regarding FDA’s development of guidance and regulations and/or the implementation of: Enforcement Authorities; Frequency and Targeting of Facility Inspections; Manner of Inspection in a Preventive Controls Environment; and Enhancement of the Reportable Food Registry (RFR).

Funding:

FDA’s progress report did not touch on what might be FSMA’s biggest obstacle: funding. The agriculture appropriations bill recently passed by the House of Representatives would decrease funding to the FDA next year by $87 million.

Hopefully, the agency is receiving abundant, constructive advice from industry that will lead to practical regulations which facilities can utilize to improve their food safety, regardless of whether FDA is able to frequently stand over their shoulders and inspect.
 

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Moving forward, the Food Safety Modernization Act (“FSMA”) requires the U.S. Food and Drug Administration (“FDA”) to issue rules governing preventive controls in FDA registered food facilities. In turn, food facilities must develop, no later than June 2012, written Hazard Analysis and Critical Control Point (HACCP) plans which are compliant with those rules.

Under FSMA, HACCP plans must identify all known or reasonably foreseeable hazards that may be associated with a food facility and then spell out the preventive controls which assure that the hazards will be minimized or prevented and food will not be contaminated.

Effective preventive controls yield safer food and are, undoubtedly, one of the top weapons against foodborne illness. Given the incredibly diverse range of food facilities and products which FDA regulates, how can its rule on preventive controls reconcile with the equally diverse range of controls needed by these facilities?

Hopefully, industry input will help. “The preventive-controls requirement of FSMA is one of the most important aspects of this historic law on food safety,” said Michael R. Taylor, deputy FDA commissioner for foods. “It’s imperative that we get information, data and feedback from industry and other stakeholders.”

FDA held a public meeting regarding preventive control rule-making in April (click on the following link to view the public meeting transcript), and is now seeking industry comment in electronic or written form through August 22, 2011. Click on the following link to submit your comments electronically or via mail.

FDA regulated food facilities should take care to review the status of preventive control rule-making, and also provide comments to help, where possible, shape the new regulations.  Click on the following link for updates on the status of FDA preventative control rule-making.
 

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In January 2000, the U.S. Department of Health and Human Services (“HHS”) published Healthy People 2010, a 10-year agenda for improving our Nation’s health. The agenda included future goals relating to the overall reduction of foodborne illness. Fast forward 10 years, and we find that the agency’s goal regarding E. coli O157:H7 (“E. coli”) was met and actually exceeded. The target for Salmonella, however, was far from the mark.

HHS had hoped that, by 2010, there would be only 1 case of E. coli O157:H7 and 6.8 cases of Salmonella reported per 100,000 people. FoodNet data from 2009 showed the actual number of E. coli illnesses was .9 per 100,000, and Salmonella illnesses was 15.2 per 100,000. The actual number of Salmonella cases in 2009 was more than double the Healthy People 2010 goal.

Industry and government (and the media) have intensely focused on E. coli since 1993. The incredible result of that focus and determination is a 41% decrease of laboratory confirmed E. coli illnesses in the past ten years (per FoodNet). Now that the data on Salmonella is clear, and following directives made by the President’s Food Safety Working Group, the Food Safety and Inspection Service (“FSIS”) and U.S. Food and Drug Administration (“FDA”) have indicated that more of their attention will be turned to Salmonella.

FSIS recently announced the implementation of more aggressive performance standards relating to the prevalence of Salmonella in chicken and turkey products. The new standards, set to take effect in July 2011, are projected by the USDA to reduce the numbers of foodborne illness in the United States by as many as 25,000 within two years.

The new standards reduce the acceptable levels of Salmonella to 7.5 percent in young chickens, which equates to a maximum allowable positive rate of 5 in 51 samples (and a slightly lower 4 in 51 samples for turkeys). The previous standard, in effect since 1996, allowed for a positive rate up to 20 percent.

Last summer, the FDA issued a much stricter food safety rule aimed at decreasing egg-related Salmonella illnesses. Under the new requirements, egg producers whose shell eggs are not processed with a treatment such as pasteurization must adopt new measures to prevent Salmonella contamination, conduct testing in the poultry house, and ensure proper refrigeration during storage and transportation.

The FDA expects the regulation to prevent approximately 79,000 cases of Salmonella each year. The FDA is also counting on new inspection powers and more funding under the Food Safety Modernization Act to factor into the success of the rule.

The HHS has set a more modest target for Salmonella in Healthy People 2020: 11.4 cases per 100,000 people. Hopefully, industry and regulator ingenuity can meet this challenge.

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The U.S. Food and Drug Administration (“FDA”) has released its annual report regarding the first year of operation of the Reportable Food Registry (“RFR”).

The RFR is an internet based portal for Registered Food Facilities to report potential problems with FDA-regulated food and feed products. Facilities that manufacture, process, pack, or hold food or feed must submit a report when there is a reasonable probability that a product will cause serious adverse health consequences to humans or animals.

The RFR was activated in September 2009 in accordance with the FDA Amendments Act of 2007 to: (1) provide a “reliable mechanism to track patterns of adulteration in food;” and (2) “to target [the FDA’s] limited inspection resources to protect the public health.”

Between September 2009 and September 2010, a total of 2,240 reportable food submissions were entered into the RFR. Of these 2,240 entries, 229 were primary reports, 1872 were subsequent reports as a result of a primary report; and 139 were amendments to previously submitted reports.

A primary report is an initial report concerning a reportable food from either industry or public health officials, while a subsequent report is a report submitted by either a supplier (upstream) or a recipient (downstream) of a food/feed (including ingredients) for which a primary report was submitted. FDA’s annual report succinctly lays out what contaminants and what types of food comprised the 229 primary reports. The pie graph below illustrates the seven food safety hazards found in the primary reports:

Sixteen (16) primary reports concerned Salmonella in spices and seasonings. The FDA reported that in response to this RFR finding, a national spice trade association is developing guidance to reduce the risk of pathogen contamination in spices. FDA also reported a second industry change driven by the RFR: one of the nation’s largest baking industry trade associations is enhancing its industry guidance on preventing unintended allergens from being introduced into bakery products.

Passage of the new Food Safety Modernization Act (“FSMA”) has also placed many new responsibilities on the FDA’s shoulders. The FSMA has increased the frequency of FDA inspections of all facilities, so whatever inspection capability is left over must be devoted to the most high-risk commodities.

Of the 229 primary reports, 226 were submitted by industry and just 3 were entered by federal and state regulatory officials.

It should be noted that 1,000 of the 1,872 subsequent reports were related to the massive recall of Hydrolyzed Vegetable Protein (“HVP”) in March 2010 due to Salmonella concerns. The manufacturer of the HVP notified its many customers of the situation and each customer then submitted a subsequent report.

The FDA annual report regarding the RFR stated that no illnesses related to the HVP recall were reported. Likewise, the report stated that no illnesses related to a separate recall for an undeclared allergen were reported. To date, it would appear that no serious health problems were reported in connection with any of the RFR reports.

The RFR also tracks data on reports concerning foods and ingredients from international sources. This first year showed that 53 of the 229 primary reports were caused by foods or ingredients from foreign sources, coming from at least 21 different countries. China caused 13 problems, the most, while Mexico took second place with 5 issues. Click on the following link to view a copy of the the FDA’s most recent RFR ANNUAL REPORT.

Moving forward, the RFR will continue to play a significant role in food safety regulation. Thus, contact our firm for additional information if you have any questions regarding how the RFR works, or the circumstances under which your own company may someday need to submit a report.
 

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In recent years, delis have greatly expanded their product portfolio, catering to a growing need for more ready-to-eat items in a faster paced world.

For these reasons, food safety in delis has never been more important.  One of the most critical control points for food safety in delis (as well as restaurants and other foodservice establishments) is the slicer, which is commonly used to slice meats, cheeses and produce.

Unfortunately, deli slicers can sometimes be difficult to clean. According to the U.S. Food and Drug Administration (“FDA”) Food Code, deli slicers should be disassembled, cleaned and sanitized per the manufacturer’s instructions at least once every four hours to prevent the growth of disease-causing bacteria.

This, of course, can create numerous challenges for food companies. First, the task may be difficult to accomplish in a busy deli or restaurant which relies on slicers throughout the day to meet unpredictable customer demand. Second, slicers may become more difficult to properly clean over time.

Seals and gaskets within a typical deli slicer may become worn or degraded as a result of heavy use and cleaning. In some instances, this can create spaces that trap debris and moisture, and these spaces may not be able to be adequately cleaned under normal conditions. Thus, slicers should be frequently examined by operators for worn or broken parts and seals, and regularly serviced by manufacturers.

Large scale foodborne disease outbreaks allegedly linked to deli slicers have recently prompted a national study on slicer food safety. In one outbreak, seventy-two patrons of a restaurant became ill with Salmonella over a three-month span. The same strain of Salmonella which sickened the patrons was found on the restaurant’s slicer.

Currently, the Rhode Island Department of Health is leading a nation-wide study regarding the extent to which inadequately cleaned or poorly designed slicers are causing foodborne illness. The department’s investigation has confirmed that slicers are not always being properly sanitized every four hours. Additionally, the department identified three brands of slicers with certain design limitations that can inhibit proper cleaning.

Hopefully, a new initiative by the FDA will bring a renewed effort on this food safety issue. The FDA developed a poster and flyer designed to raise awareness of the sanitation concerns with slicers. The poster, which explains the importance of proper slicer maintenance and highlights examples of hard-to-clean problem areas, can be tacked up right beside a slicer.

The flyer provides tips for food safety professionals inspecting deli slicers. Click on the following link for the FDA’s press release, or to download or order the poster and flyer at no charge.
 

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The FDA Food Safety Modernization Act (“FSMA”) is now law.

The FSMA is the first major amendment in almost 75 years to the food safety regulations of the Federal Food, Drug and Cosmetic Act.

Since FDA regulated manufacturers may feel overwhelmed by the 89 page act, let’s take a deep breath and walk through some of the FSMA’s key provisions -- and when they go into effect.

The FSMA governs food products regulated by the FDA; it does not apply to meat, poultry or egg products regulated by the USDA. The new law grants additional power to, and also places additional requirements on, the FDA:

• Inspections: FDA must inspect high-risk food processing facilities at least once in the next five years, and once every three years after that. Low-risk facilities must be inspected at least once every seven years. [Effective immediately].

• Detentions: FDA has the authority to detain food product if it has “reason to believe” that a product is adulterated or misbranded and may cause harm to humans or animals. This is a lower standard than under the FD&C Act. [Effective June 2011].

• Suspensions: FDA may now suspend facility operations if it believes there is a reasonable probability that food from the facility could cause harm to humans or animals. [Effective June 2011 or upon FDA’s issuance of regulation to implement].

• Recalls: FDA now has the authority to force a food recall. [Effective immediately].

• Performance Standards: FDA must evaluate relevant health data every two years to determine the most significant foodborne contaminants and then issue guidance documents or regulations setting contaminant-specific performance standards. [Effective date undetermined, implementation requires FDA rulemaking].

• Imports: FDA may require importers to provide a safety certification from an accredited third-party auditor as a condition of granting admission. [Effective immediately.]

Under the FSMA, food companies will also now have to develop and implement Hazard Analysis and Critical Control Point (HACCP) plans. Although this may initially be a burdensome task, companies implementing strong HACCP protocols will, most importantly, produce safer food. And further, companies executing good HACCP controls may see strong inspection results and avoid detentions, suspensions and recalls.

The written HACCP plan must include five elements:

• Hazard Analysis: Food companies must identify and evaluate all known or reasonably foreseeable hazards that may be associated with the facility (such as biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives, and hazards that may be intentionally introduced) and prepare a written hazard analysis.

• Preventative Controls: Food companies must identify and implement preventive controls to provide assurances that hazards identified in the hazard analysis will be significantly minimized or prevented and the food processed by the facility will not be adulterated or misbranded.

• Monitoring: Food companies must monitor the effectiveness of the facility’s preventive controls.

• Corrective Actions: Food companies must establish procedures to ensure that, if preventive controls are not properly implemented or are found to be ineffective: (a) appropriate action is taken to reduce the likelihood of a recurrence (b) all affected food is evaluated for safety (c) all affected food is prevented from entering commerce if the company cannot ensure it is not adulterated.

• Verification: Food companies must verify that the facility’s preventive controls are adequate to control the hazards identified in the hazard analysis, that monitoring is being conducted, that appropriate decisions about corrective actions are being made, and that there is periodic reanalysis of the HACCP plan.

In addition, food companies must maintain, for not less than 2 years, records documenting the monitoring of the preventive controls, instances of nonconformance material to food safety, the results of testing and other means of verification, corrective actions, and the efficacy of preventive controls and corrective actions. These records must be made available to FDA upon request.

Food companies, other than small businesses, must have their HACCP protocols in place by June 2012.

Other notable requirements placed on food companies by the FSMA include:

• Registration:  Food companies must register with the FDA biennially, between October 1 and December 31 of each even-numbered year. [Effective immediately.]

• Imports: Food importers must perform risk based foreign supplier verification activities to verify that the food imported is not adulterated. [Effective January 2013.]

• Additional Future Performance Standards: Food companies must engage a Federal laboratory or other accredited laboratory to perform analyses of food products and submit the results directly to the FDA. [Effective January 2013.]

While many of the FSMA’s key provisions do not take effect for a year or more, it is critical that food companies begin planning for these changes now. If your company already operates under the HACCP methodology, now is the time to re-evaluate your plan and verify it will comply with the FSMA standards. If your company has not yet implemented a HACCP system, now more than ever is the time to enhance your food safety system with formal recognition and monitoring of potential hazards.

Please contact us with any questions regarding these significant changes in food safety law.

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After weeks of haggling, Congress has now passed the Food Safety Modernization Act.

A few weeks ago, we all thought the new law (passed in its then-current form) was headed for the President’s desk. We soon learned, however, that the legislation which had passed was, in fact, technically unconstitutional. Because the bill inadvertently contained certain revenue provisions, it should have originated in the House of Representatives, not the Senate. These issues have been resolved, Congress approved the legislation shortly before Christmas, and the bill is now heading to the White House.

Click on the following link to view the text of the bill:  Food Safety Modernization Act.

The Food Safety Modernization Act (“FSMA”) will govern food processors and products regulated by the U.S. Food and Drug Administration ("FDA"). The new act increases federal inspections, requires virtually all regulated food companies (with very few exceptions) to adopt Hazard Analysis and Critical Control Point (“HACCP”) plans, and grants the FDA mandatory recall authority. The new legislation also proposes to enhance our nation’s foodborne illness surveillance and tracking capabilities.

The biggest change for food companies, however, will be the new HACCP requirements. Under the new law, food companies will be required to: (1) formally consider and identify all potential food safety hazards associated with their products and operations; (2) develop written plans to respond to each of those hazards; and (3) to closely follow those plans to reduce or eliminate such hazards to the greatest extent possible.

Not only will the HACCP plans developed by these companies need to be legally adequate (something which will likely prove extremely difficult to define and enforce on a consistent basis), the resulting plans themselves will also, for all practical purposes, become an extension of in-plant federal regulation.Thus, as companies develop and implement their own individualized HACCP plans, they should also recognize that they will be expected by FDA to follow them precisely. Click on the following link to see a more in-depth discussion of the new law and possible ramifications: Jolley: Bill Marler & Shawn Stevens Talk About The New Food Safety Modernization Act .

Although not all provisions of the new legislation will go into effect immediately, food companies should begin planning for the changes that are likely to occur.

There have also been some recent notable developments relating to produce. Beyond the FSMA itself, the FDA has also announced the creation of a new organization that will likely impact produce growers and packers in the near future. The Produce Safety Alliance is a public-private organization funded by the FDA and United States Department of Agriculture’s Agricultural Marketing Service.

The three-year, $1.15 million alliance aims to help produce growers and packers access food safety educational and training materials by:

• Developing a program on Good Agriculture Practices (GAPs) and co-management;

• Creating an information bank of up-to-date scientific and technical information related to on-farm and packinghouse produce safety and environmental co-management;

• Establishing a network of educational collaborators;

• Conducting an assessment of existing educational outreach tools to identify knowledge gaps and to provide for continuous updating; and

• Launching a website to make the alliance’s work and information readily accessible.

The alliance was also created to assist growers and packers with a new produce safety regulation that the FDA expects to propose in 2011, which will focus on production, harvesting and packing. FDA Deputy Commissioner for Foods Michael Taylor said “As we traveled around the country listening to growers and packers and soliciting their comments even before we propose a produce safety rule, we have committed ourselves to just this kind of collaborative effort.” As always, share your experiences and views with FDA at every opportunity afforded to you.

Put simply, the Produce Safety Alliance aspires to create a one stop shop for the food safety needs of produce growers and packers. The California Leafy Greens Marketing Agreement (LGMA) endorses the alliance and hopes to participate on the alliance’s steering committee. Jamie Strachan, chairman of the LGMA’s advisory board said “The objectives of this new initiative are in line with those of the LGMA.” The alliance’s steering committee will be comprised of government officials as well as industry leaders, including growers and packers and produce trade organizations.

In any event, one question often asked is whether the FSMA will make our food safer. I think the answer is yes. Regardless of where you stand politically on the issue, I think we could all agree that requiring all food companies to develop and follow HACCP plans will have a net positive effect on food safety. Moreover, under the new laws, it should become easier for food safety lawyers like us to defend food companies faced with a foodborne illness claim or caught in an outbreak scenario.

In response to the new rules and regulations now on the horizon, most food companies will be working to enhance their food safety programs. Understanding that, despite our best efforts, mistakes can and will occur, we would much rather be defending food companies with robust food safety programs than defending those companies with none at all.
 

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The FDA’s Reportable Food Registry (“RFR”) has now been up and running for a full year.  So, has the RFR been successful?

As we discussed previously, the RFR is an internet based portal through which food manufacturers must notify the FDA of food products that have a “reasonable probability” of causing health problems or death in humans or animals. The RFR applies to any food product regulated by the FDA, with the exception of infant formula and dietary supplements.

This summer, the FDA issued a report on the RFR’s first seven months of operation, September 2009 through March 2010. Click on the following link to view a copy of the THE 2009 - 2010 FDA RFR REPORT.

During the first seven months, food companies submitted 125 “primary reports” through the RFR. A primary report is an initial report concerning a reportable food from either industry or public health officials, such as federal, state, or local regulators. Of those 125 primary reports, 122 were from industry, and 3 were from regulatory officials.

Also during that initial period, 1,638 “subsequent reports” were submitted as a result of a primary report. A subsequent report is a report submitted by either a supplier (upstream) or a recipient (downstream) of a food/feed (including ingredients) for which a primary report was submitted.

The FDA classified the 125 primary reports into seven food safety hazard categories, as illustrated in the pie graph below:

Percent Distribution of 125 Primary RFR Entries by Food Safety Hazard

Because this initial reporting period was so brief, the FDA wisely cautions that inferences cannot be drawn from this data. Nevertheless, the figures are still interesting.

More meaningful, however, is that of the 125 reports, only one caused a health problem – “an allergic-type reaction” in four family members. The FDA pointed out that all the reports had the potential to bring harm. However you want to interpret the fact that there was only a single health problem, it cannot be lost among the other numbers. Perhaps it highlights how the RFR brings an abundance of caution that will only make our food supply even safer.

And a meaningful statement was made by the FDA’s Deputy Commissioner for Foods, Michael Taylor. When asked how industry reacted to the RFR, Taylor said “The industry is taking it very seriously. They know it is a legal duty.” We are in a period of consumer distrust. I would like to share with consumers that not only does industry take food safety regulation seriously, I have personally experienced food manufacturers setting their safety standards above and beyond their legal obligation. Although recent media may suggest otherwise, our food manufacturers, with the exception of a few, care deeply about safety.

After just one year, it is too soon to determine whether the RFR will meet its goals of tracking patterns of adulteration and targeting the FDA’s limited inspection resources. The FDA has labelled the RFR’s first seven months “a success story.” It was not a perfect first year – the electronic submission process was already overhauled once; and questions still remain – how many of the potentially hazardous situations would have been reported under regulation in place prior to the RFR?

In any event, we will continue, of course, to answer your questions about RFR compliance and monitor new RFR developments.

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The FDA's Reportable Food Registry (“RFR”) first went into effect in September 2009. Since then, we have been watching closely the application and enforcement of the RFR.

At its core, the RFR is an internet based portal which requires certain food companies to report the discovery of potential problems with food products. Generally speaking, under the RFR, a food company may have an obligation to inform the FDA – and file a report through the RFR website portal – if it learns that it has manufactured, received or distributed a "reportable food." In turn, a reportable food is defined generally as any food product that has a “reasonable probability” of causing health problems or death in humans or animals.

When the RFR portal was initially unveiled, the FDA issued draft guidelines to assist industry in complying with the new requirements. Nearly ten months later, with mixed reactions, the guidance has been revised: “Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007”.

Notable changes include:

• Human food containing an undeclared major food allergen as defined in the Food Allergen Labeling and Consumer Protection Act (FALCPA) may be a reportable food.

• If a facility receives a bulk trailer shipment (and the driver leaves), but the shipment is rejected before it is off-loaded, the facility must still submit a report.

• A report pertaining to a food later determined by FDA not to be a reportable food will be purged from the RFR, but will remain in FDA’s records, subject to normal record retention requirements.

• A Registered Food Facility must submit a reportable food report even if the reportable food is intended solely for export.

• A foreign Registered Food Facility is not required to submit a reportable food report for a reportable food that is not shipped to the U.S.

The latest edition of the draft guidelines, however, also addresses some important additional issues brought to light by industry reaction to the initial draft.

For instance, although a food company is not required to report a problem if it was the sole manufacturer of a food product, it discovered the problem internally, and then corrected the problem before the food left its control, the previous guidelines did not specifically address what should happen when potentially reportable foods are shipped to different facilities within the same company.

Because food passes through many different hands from farm to fork, sometimes between facilities under the same corporate umbrella, industry experts expressed concern regarding the meaning of “transfer” in the exemption.

Now, the draft guidelines specify that an intra-company transfer in a vertically integrated company is not a “transfer to another person” under the RFR. Thus, a facility is not required to submit a reportable food report when:

• The adulteration originated with the responsible party; and
• The responsible party detected the adulteration prior to any transfer to another person (or, to another facility not owned or controlled by the company); and
• The responsible party:
  • Corrected the adulteration; or
  • Destroyed or caused the destruction of the food.

It is important to note, however, that the FDA still considers a food product to have been “transferred” when the food is shipped to a third-party warehouse, even if the responsible party maintains ownership and direct control over distribution of the specific product.

In any event, the FDA is seeking comments on Edition 2 of the draft guidance, and is specifically requesting feedback on the revised meaning of “transfer.” If your business is accountable to the RFR, take some time to review the guidelines. Click on the following link to download the FDA RFR Guidelines (2nd Ed.).

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Eggs have been taking a lot of heat lately. The question, of course, is whether it could have been avoided.

Reviewing the most recent FSIS New Technology Information Table, I discovered that a number of the new additions pertain to egg products. And, in light of the recent developments (and scrutiny) involving eggs, there can be no doubt Professor Kevin Keener, of Purdue University, similarly hopes to see his own rapid egg cooling innovation embraced by regulators and industry soon.

Professor Keener has developed a process to quickly cool eggs to 45° (which significantly limits the ability of Salmonella to grow) after laying and processing. This is quite significant in light of the FDA research which Professor Keener cites: studies from the FDA show that if eggs were cooled and stored at 45 degrees or less within 12 hours of laying, there would be an estimated 78 percent fewer Salmonella illnesses from eggs in the United States each year.

The system involves placing eggs in a chamber with carbon dioxide gas at about minus 110 degrees. The cold gas circulates around the eggs and forms a thin layer of ice on the inside of the shell. The ice layer then melts and quickly lowers the egg’s temperature.

Not only does the cooling process have the potential to reduce food-borne illness, it is projected to increase egg shelf life by about four weeks. An extended shelf life also creates the potential opportunity for eggs to be exported. Professor Keener believes the technology can be easily integrated into large scale production without slowing operations, costing between two and five cents per dozen eggs.

The egg cooling technology thus far seems to be a winning proposition. Nevertheless, as scientists and industry continue to research and cultivate the best food safety defences, always remember that raw eggs must be properly handled and cooked.

And if you have not yet read my latest post at Meatingplace – Legally Speaking, please check it out: Salmonella: Surveying the science and sensationalism.

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There are endless numbers and statistics thrown around each day by the government, industry and consumers, along with different interpretations and explanations for each.

The CDC recently announced, for instance, that food-borne disease outbreaks and food-borne illnesses dropped by 8 and 15 percent, respectively, in 2007. Although we would like to believe that the reduction is a sign that food safety is headed in the right direction, the CDC has theorized that the decline is due to an increase in immunity to norovirus.

In turn, legislators are calling on the USDA and beef manufacturers to begin testing product for six non-O157 STEC strains. As one justification, rule makers point to the CDC’s estimate that that non-O157 STECs cause 36,700 illnesses, 1,100 hospitalizations and 30 deaths each year. However, legislators fail to mention one key statistic: very few non-O157 STEC outbreaks have been caused by ground beef.

Although numbers and statistics are not always clear cut, and are subject to interpretation, they are increasingly shaping FDA and FSIS policy making.

On March 30, 2010, CDC, FDA and FSIS (the “Agencies”) jointly held their first public workshop on “Measuring Progress on Food Safety: Current Status and Future Directions". The Agencies’ hope to identify the best metrics to better quantify the true incidence of food-borne illness and which pathogens and foods are most at fault. In turn, they plan to use those measurements to directly gauge which policy changes are lowering the incidence of food-borne illness.

Further, the Agencies want to identify the best metrics to monitor food safety at each step in the farm to fork continuum. The FSIS, in its Federal Register Notice, put forth these queries to the industry:

• What metrics do industry members have in place to assess whether suppliers meet purchase specifications that address food safety?
• What metrics do industry members have in place to assess the safety of the finished products?
• What metrics do industry members employ to evaluate the effectiveness of their food safety systems?
• Has industry found some metrics that have been particularly effective in evaluating food safety?
• Are there other metrics that industry has found to be inadequate for measuring food safety?

The Agencies held another public meeting regarding “Measuring Progress” in July and will be holding a final public meeting on October 20, 2010 in Portland.

At this final meeting, industry (and state regulators and consumer groups) are encouraged to make presentations on metrics. The Agencies will also provide updated information about their current thinking on the use of metrics to measure food safety.

Since numbers and statistics can be so ambiguous, it is imperative that industry shares their knowledge of which metrics work – and which do not. The Agencies are looking to tie numbers to their policies. Since we are all strive to lower the incidence of food-borne illness, let’s make sure that meaningful statistics encourage constructive regulations.

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On March 14, 2009, President Obama announced the creation of the Food Safety Working Group. The group is currently chaired by Secretary of Health and Human Services Kathleen Sebelius and Secretary of Agriculture Tom Vilsack.

Appearing after the PCA peanut butter outbreak and recall, the Working Group was formed in response to an increasing number of foodborne illness outbreaks in recent years, and was tasked with the responsibility of recommending changes to food safety regulations, fostering better coordination between federal agencies, and ensuring the enhanced enforcement of numerous food safety laws.

In May 2009, the Working Group launched its website (foodsafetyworkinggroup.gov) and held a public “listening day” to solicit input from federal and state health officials, food industry, consumers and others. Then, four months following its creation, the Working Group announced its three core principles: (1) working to prevent harm to consumers as a first priority; (2) recognizing that effective food safety inspections and enforcement depend upon good data and analysis; (3) committing to quickly identify and stop foodborne illness outbreaks.

To facilitate these goals, the Working has Group assisted, in varying degrees, with the development of numerous food safety issues in the past year. Below are just a few of the initiatives recently encouraged and embraced by the group:

• FDA’s new rules to combat Salmonella contamination in eggs.

• FDA request for comments on proposed guidance to reduce microbial contamination of tomatoes, melons and leafy greens.

• USDA's new initiatives aimed at testing bench trim for E. coli O157:H7 and the issuance of draft guidelines on methods for controlling E. coli O157:H7 on the farm.

• The enhancement of www.FoodSafety.gov and content for consumers.

• The opening of the Commercial Targeting and Analysis Center to better ensure the safety of imported foods.

• FDA’s activation of the Reportable Food Registry designed to more quickly identify and track adulterated food products.

• The decisions by FSIS, FDA, and CDC to host joint food safety meetings for input and collaboration on performance measures for food safety.

• The recent decisions by USDA and FDA to conduct additional public meetings regarding product tracing and tracing source materials for E. coli O157:H7 in beef.

These, of course, represent many significant food safety initiatives made possible by substantial governmental and industry collaboration.  So, although the President announced during the creation of the Working Group that “[t]here are certain things [such as ensuring safe food] that only a government can do,"  we would simply note that his statements only paint a partial picture.

Let there be no mistake, Americans do enjoy one of the safest food supplies in the world in part because of continued governmental oversight. But, it is also important to note that American consumers enjoy one of the safest food supplies in the world in a much larger part because of the efforts of the hard-working Americans who actually feed our families. Thus, while government can regulate industry, only industry and its individual members can safety and successfully feed a nation.

So, is the Working Group still working? Of course. But, let us not forget that so are you. Thus, once again, we would like to say "thank you" to all those who work tirelessly, each and every day, to provide safe food for each of us and our families.

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Everyone feels sick about the vast amounts of oil continuing to leak into the Gulf of Mexico. And, for the last 2 months, it has been impossible to visit your favorite news site without cringing at the depressing headlines and photos.

Thankfully, however, in addition to the ongoing containment and clean-up efforts, our government and the seafood industry are working diligently to protect us from becoming ill (literally) from seafood tainted by the massive spill.

The Food and Drug Administration (“FDA”) is working with the National Oceanic and Atmospheric Administration (“NOAA”) and other federal and state agencies to monitor the safety of seafood from the Gulf. The agencies have issued several assurances to the public that their efforts should prevent any contaminated seafood from reaching our shores.

The NOAA’s first action was to swiftly close waters polluted by the oil spill to fishing and shellfish harvesting. NOAA has the authority to close Federal waters, and also works closely with the coastal states (who have authority to close waters within 3 miles of their shoreline). These closed areas continue to expand as the agency monitors the movement of the oil. A map of the closed Federal waters illustrates the enormity of the situation and its impact on our seafood industry.

The FDA affirms that “closing harvest waters which could be exposed to the oil is the best way to protect the public from potentially contaminated seafood, because it keeps the product from entering the food supply.” It has been over 60 days since the oil began pouring into the Gulf, and the well is still releasing as much as 2.5 millions of gallons of oil each day.

So, when will seafood from the region be safe again?

FDA and NOAA have a plan to answer this vital question. Under the plan, harvest waters will not re-open until oil from the spill is no longer present and the seafood samples from the area pass both sensory analysis by trained experts and a chemical analysis to ensure there are no harmful residues.
Some coastal food processing plants are still able to harvest product from Gulf areas not yet affected by the spill. These processors are complying with a surveillance sampling program just implemented by the FDA by providing samples of oysters, crabs and shrimp for pollutant testing. This current testing, and the analyses to be performed once waters are re-opened, will verify that the seafood on our tables is safe to eat.

On June 14, 2010, the FDA distributed a letter to seafood processors emphasizing the processors’ obligations under the FDA’s Fish and Fishery Products Regulation. Click on the following link to view a copy of the FDA Letter. FDA urges processors to verify that their HACCP plans account for the hazard created by the oil spill, and to reassess the plans as needed. FDA also advises processors on their duty to only process fish and shellfish harvested from waters that have not been closed. FDA and NOAA said they would increase inspections to ensure that processors maintain proper documentation on the origin of their products.

While we can feel confident in the federal food safety strategy to deal with this disaster, the full impact of this spill on the Gulf Coast seafood industry will not be known for years. Thirty percent of the Gulf of Mexico federal waters are currently closed, with no re-open date in sight.

AmeriPure, one of America’s largest suppliers of Gulf oysters, just temporarily closed its doors because it could not harvest enough to keep operating. AmeriPure is remarkable for the pasteurization-like process it applies to its oysters. The process does not affect quality, but leaves the oysters safe to eat. We applaud AmeriPure’s commitment to food safety, and extend our sincere hope to both the company and seafood industry that the well can be quickly capped and seafood, rather than oil, will once again begin flowing from the Gulf.

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Since its launch in September 2009, we've been watching closely the application and enforcement of the FDA's Reportable Food Registry (“RFR”).

According to the FDA, the purpose of the RFR is to provide a “reliable mechanism to track patterns of adulteration,” and “to target the agency's limited inspection resources where they're needed most.”

The RFR, at its core, is an internet based portal which requires certain food companies to report the discovery of potential problems with food products. Generally speaking, under the RFR, a food company may have an obligation to inform the FDA – and file a report through the RFR website portal – if it learns that it has manufactured, received or distributed a "reportable food." In turn, a reportable food is defined generally as any food product that has a “reasonable probability” of causing health problems or death in humans or animals.

When the RFR portal was initially unveiled, the FDA issued draft guidelines to assist industry in complying with the new requirements. Nearly ten months later, with mixed reactions, the guidance has been revised: “Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007”.

Notable changes include:

• Human food containing an undeclared major food allergen as defined in the Food Allergen Labeling and Consumer Protection Act (FALCPA) may be a reportable food.

• If a facility receives a bulk trailer shipment (and the driver leaves), but the shipment is rejected before it is off-loaded, the facility must still submit a report.

• A report pertaining to a food later determined by FDA not to be a reportable food will be purged from the RFR, but will remain in FDA’s records, subject to normal record retention requirements.

• A Registered Food Facility must submit a reportable food report even if the reportable food is intended solely for export.

• A foreign Registered Food Facility is not required to submit a reportable food report for a reportable food that is not shipped to the U.S.

The latest edition of the draft guidelines, however, also addresses some important additional issues brought to light by industry reaction to the initial draft.

For instance, although a food company is not required to report a problem if it was the sole manufacturer of a food product, it discovered the problem internally, and then corrected the problem before the food left its control, the previous guidelines did not specifically address what should happen when potentially reportable foods are shipped to different facilities within the same company.

Because food passes through many different hands from farm to fork, sometimes between facilities under the same corporate umbrella, industry experts expressed concern regarding the meaning of “transfer” in the exemption.

Now, the draft guidelines specify that an intra-company transfer in a vertically integrated company is not a “transfer to another person” under the RFR. Thus, a facility is not required to submit a reportable food report when:

• The adulteration originated with the responsible party; and
• The responsible party detected the adulteration prior to any transfer to another person (or, to another facility not owned or controlled by the company); and
• The responsible party:
  • Corrected the adulteration; or
  • Destroyed or caused the destruction of the food.

It is important to note, however, that the FDA still considers a food product to have been “transferred” when the food is shipped to a third-party warehouse, even if the responsible party maintains ownership and direct control over distribution of the specific product.

In any event, the FDA is seeking comments on Edition 2 of the draft guidance, and is specifically requesting feedback on the revised meaning of “transfer.” If your business is accountable to the RFR, take some time to review the guidelines. Click on the following link to download the FDA RFR Guidelines (2nd Ed.).  They're a good read.

Ultimately, sharing helpful perspective and feedback with FDA today could help mitigate downrange confusion and, perhaps, even save your company from appearing in the RFR in the future.

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According to FDA, Caldwell Fresh Foods has announced a voluntary recall of alfalfa sprouts because of possible Salmonella concerns.

The alfalfa sprouts subject to the recall are labeled and packaged as follows:

• Caldwell Fresh Foods - 4-ounce plastic cups and one pound plastic bags, and 2-pound and 5 pound plastic bags in cardboard boxes with sticker affixed with the printed words Caldwell Fresh Foods.
• Nature's Choice - 4-ounce plastic cups
• California Exotics brands - 5-ounce plastic clamshell containers

The alfalfa sprouts were distributed to a variety of restaurants, delicatessens and retailers nationwide. In California, the products were sold at Kings Super Market, Numero Uno Stores, Cárdenas Markets, Trader Joe's Stores, Gonzalez Northgate Markets, Wal-Mart stores Jons Markets, and Canton Foods. Click on the following link to view the FDA Recall Release. 

Caldwell Fresh Foods alfalfa sprouts not affected by this recall will have a bright, round, green sticker affixed to the lids and labels.

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According to the CDC, incidence rates of E. coli O157:H7 decreased significantly in 2009 from recent averages, reaching the lowest level since 2004.

Moreover, for the first time, the number of reported cases actually fell below the federal 2010 Healthy People target of less than one case per 100,000 people.

As explained by Dr. David Goldman, assistant administrator of the FSIS Office of Public Health Science, the report “confirms our success in combating food-borne illness by setting an aggressive goal, designing an effective system to meet that goal, and [then] relentlessly implementing it.”

The most recent food-borne illness incidence data was collected and analyzed through FoodNet, a collaborative project including the CDC, USDA, FDA and various state health departments. FoodNet conducts active surveillance for nine pathogens, including Campylobacter, Cryptosporidium, Cyclospora, E. coli O157:H7, Listeria, Salmonella, Shigella, Vibrio and Yersinia. Click on the following link to learn how food-borne illnesses are tracked.

According to Dr. Chris Braden of the CDC, "the report indicates that there have been reductions in illness caused by many of these pathogens." Braden further explained that, “since FoodNet began surveillance in 1996, . . . [most] of the pathogens that we track have all declined."

And, while E. coli O157:H7 and shigella cases showed encouraging recent declines, the federal targets for Campylobacter, Listeria, Salmonella and Vibrio have not yet been met. Vibrio infections, for instance, increased by 85 percent compared with the first three years of surveillance, and Salmonella fell short of the goal.

Many Vibrio infections result from eating raw or undercooked shellfish, especially oysters. In turn, Salmonella is often difficult to combat because it can originate and spread from a wide variety of foods and environmental sources. In addition to foods, Salmonella has been associated with animals like baby chicks, small turtles, reptiles and frogs. And, as noted, while incidence levels for campylobacter and listeria continued to decline significantly, they still did not meet "Healthy People" targets.

In addition to the expected Senate passage of the Food Safety Modernization Act next month, the FDA is also moving forward with additional food safety initiatives aimed at decreasing food-borne illness. Dr. Jeff Farrar, the FDA’s associate commissioner for food protection, noted that the agency is still pursuing new requirements aimed at reducing the incidence of Salmonella during shell egg production. These initiatives are expected to become effective this summer, while FDA also works to develop a proposed rule which will likely include risk-based safety standards for produce.

If we are really serious about reducing food-borne illness, however, such initiatives and regulations are only one part of the overall equation. Much greater progress can likely be achieved – more quickly – if more consumers recognize the importance of properly handling and preparing raw animal foods. If all consumers can be educated to assume raw chicken, meat and eggs carry bacteria that can cause illness, to take additional precautions to avoid cross-contamination, and to cook all raw animal products to a safe temperature, consumers can significantly reduce their risk of becoming ill.

In this regard, better “Educated People” will more quickly and readily translate into far more “Healthy People.”

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According to the Center for Science in the Public Interest (CSPI), Hawaii ranks among the top states for food-borne illness surveillance, investigation and reporting. Other leading states include Maine, Kansas, Wyoming, Vermont, Alaska and North Dakota. Minnesota and Oregon are also regarded as having strong surveillance systems as well.

While many states ranked very high, however, some problems do remain.

According to CSPI, “some states may not have enough investigators or the money to train and equip their staff, which can lead to lower-quality investigations.” In addition to affecting the quality of such investigations, these and other limitations can also lead to mistaken conclusions regarding the source or cause of an outbreak.

CSPI also reports, however, the FDA Food Safety Modernization Act, which passed in the House of Representatives and is now pending in the Senate, will likely help improve national surveillance capabilities. If passed, the Act would require FDA to improve coordination between federal, state and local surveillance systems; develop a national network of laboratories; and improve epidemiological tools available to the states. The bill would also integrate food-borne illness surveillance with other bio-surveillance capabilities

Thus, as we strive to improve the safety of our food, as well as the ability of our food safety system to accurately detect and resolve emerging problems, we send our congratulations to the hard-working professionals in Hawaii and other states who are leading the way.

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It's no secret that virtually all foods are safe if handled properly.

Indeed, according to FDA, most food-borne illnesses are avoidable if consumers follow proper food handling techniques. This is true whether consumers are shopping for products, transporting them home or preparing them in their kitchen.

While proper handling and cooking is key, food safety starts at the grocery store. By following safe food handling practices while shopping, consumers can significantly reduce the potential for food-borne illness at home. In this Consumer Update video, FDA Consumer Safety Officer Doriliz De León guides consumers through a local grocery store while explaining how they can – and should – do their part to keep both their foods and families safe.

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The FDA's Reportable Food Registry ("RFR") first went online in September 2009.

Since its inception, numerous questions have been asked regarding the specific circumstances under which a food company is required to inform the FDA about a potentially dangerous food product.

Generally speaking, under the RFR, any food company may have an obligation to inform the FDA – and file a report through the RFR website portal – if the company learns that it has manufactured, received or distributed a potentially implicated food product.

Because the FDA reporting requirements are only triggered under certain defined circumstances, however, a food company uncertain about its reporting obligations under the registry should consider contacting legal counsel to determine the extent and scope of any potential reporting requirements triggered by the FDA rules.

In their current form, the FDA rules extend to any company that is required to submit registration information to the FDA as a manufacturer, processor, packer, or distributor of food. In turn, the rules apply to any food product regulated by the FDA, with the exception of infant formula and dietary supplements which are covered by other regulatory requirements.

Under existing FDA rules, a food company is required to alert the FDA – through the RFR Portal – within 24 hours of becoming aware it has sold and shipped a "reportable food." In turn, a reportable food is defined generally as any food product that has a “reasonable probability” of causing health problems or death in humans or animals. As explained by the FDA, some examples of reasons a food may become reportable include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.

In turn, once a food company discovers a problem with a product it has received, manufactured or shipped, and submits a report through the RFR, it will be required to cooperate with the FDA to help determine the cause and contain any potentially affected products. In addition, responsible parties will be required to notify their relevant suppliers, distributors and customers of any potential food safety issues, be ready to submit further data and analysis to the FDA, and initiate their own investigation if the problem is thought to have originated internally.

Notably, however, in addition to other exceptions, the FDA’s reporting requirements apply only to products that have been shipped into commerce. For this reason, a food company is not required to report a problem to the FDA if it was the sole manufacturer of the food product, it discovered the problem internally before the food product was distributed, and it then corrected the problem or destroyed the implicated food.

For additional information on the registry and reporting requirements, please visit www.fda.gov/ReportableFoodRegistry.

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According to the FDA, Basic Food Flavors (of Las Vegas, Nevada) has announced a recall of hydrolyzed vegetable protein (HVP) paste and powder. HVP is a common ingredient used most frequently as a flavor enhancer in many processed foods, including soups, sauces, chilis, stews, hot dogs, gravies, seasoned snack foods, dips and dressings.

The recall of HVP was announced following the discovery of Salmonella Tennessee in certain product samples, along with other samples reportedly collected at the company’s processing facility. In turn, Basic Food Flavors announced a recall all HVP in powder and paste produced and distributed by the company since Sept. 17, 2009. Click on the following links to view a copy of the FDA News Release and FDA Recall Information.

Although, to date, there have been no reported illnesses associated with the consumption of any food products affected by the recall, the FDA and CDC report that they are currently assessing and closely monitoring the potential risks of illness from affected products.

The FDA is also advising industry that any recalled bulk HVP product should be destroyed or reconditioned according to FDA-approved procedures. Click on the following link for Product Handling And Reconditioning Information. Under the guidelines, FDA is allowing companies to recondition potentially affected HVP if thier processing contains protocols validated to inactivate Salmonella. 

Additionally, according to FDA, companies will not be required to recall any food products containing HVP if the products have validated cooking instructions which are sufficient to inactive Salmonella, FDA is recommending that any down-stream food companies that used HVP as an ingredient in food products which might be eaten by consumers without any further processing or cooking to address the potential risk, however, consider recalling such products. Under new FDA guidelines, certian companies may also have reporting obligations under the Reportable Food Registry.

In any event, additional information relating to potentially affected products can be found at www.foodsafety.gov.

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The FDA's Reportable Food Registry ("RFR") first became active in September 2009. 

In 2007, former President Bush signed into law the Food and Drug Administration Amendments Act (Public Law 110-85). The Act, which amended the Federal Food, Drug and Cosmetic Act by creating a new section 417 (21 U.S.C. 350f), required the Secretary of Health and Human Services to establish a mandatory reporting registry for potentially dangerous foods. The stated purpose of the amendment was to provide FDA with “a reliable mechanism to track patterns of adulteration in food.” Implementation of the new law, however, was delayed while the FDA worked on developing an effective electronic reporting system.

Now that the Reportable Food Registry (“RFR”) is up and running, a food company may be required to alert the FDA (through the RFR Portal) within 24 hours of becoming aware it has received, sold or shipped a "reportable food." According to the FDA, a reportable food is defined as any food product that has a “reasonable probability” of causing health problems or death in humans or animals. 

Because reporting is only required under specific circumstances, however, any company uncertian about its reporting duties should seek legal advice to determine the extent and scope of any reporting requirements under the RFR.

For additional information on the registry and reporting obligations, please visit www.fda.gov/ReportableFoodRegistry.

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According to the FDA, Johnny's Fine Foods (of Tacoma, Washington) has announced a precautionary and voluntary recall of various French Dip Powdered Au Jus Products distributed to retail outlets nationwide.

The products subject to the recall include: (1) French Dip Powdered Au Jus in 6oz bottles; and (2) French Dip Powdered Au Jus in 1.1oz foil packets.

The Johnny's French Dip Powdered Au Jus 6oz is packaged in a clear plastic bottle with a red, white and blue label. The expiration date for this product is 0332. The Johnny's French Dip Powdered Au Jus 1.1oz is packaged in a red, white and blue foil packet. The expiration date for this product is 02212. Both of these products had been distributed nationwide and are sold in retail stores. Click on the following link to view a copy of the FDA Recall Release.

The recalled products were made using hydrolyzed vegetable protein manufactured by Basic Food Flavors (located in Las Vegas, Nevada). Basic Food Flavors initiated a recall of the hydrolyzed vegetable protein following discovery of Salmonella contamination during testing. It is also important to note, despite the issuance of a precautionary recall, that to date there have been no reported illnesses associated with the consumption of these products.

According to the company, the recalled products should be discarded. Additionally, consumers with any questions may contact Johnny's Fine Foods at 1-800-962-1462, Monday through Friday (8am to 3pm Pacific Standard Time).

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According to the FDA, Wholesome Spice (of New York) has announced a recall of crushed red pepper because of a potential link to illnesses associated with an ongoing nationwide Salmonella Montevideo Outbreak. As of February 24, there had been as many as 238 individuals from 44 states infected with the outbreak strain.  Click on the following link to view a copy of the most recent CDC Outbreak Report.

Wholesome Spice manufactured and then distributed the crushed red pepper to Daniel International for use in the production of various sausage and salami products which had been previously recalled by Daniel. Click on the following link to view Previous Daniel Recall Updates.  According to reports, a broad investigation into the source of the contamination was ongoing, and FDA recently discovered that samples of Wholesome Spice crushed red pepper had tested positive for the outbreak strain. In response, Wholesome Spice immediately announced a recall of all potentially affected products.

The Wholproducts subject to the recall include all lots of 25 pound boxes of Crushed Red Pepper sold by Wholesome Spice between April 6, 2009 and January 20, 2010.

The Crushed Red Pepper was packaged in a clear plastic bag, which was then placed inside a cardboard box marked with an adhesive white label containing a blue border and blue and black lettering. The brand name on the product labels is WHOLESOME SPICES. The product name is listed as CRUSHED RED PEPPER. The 25 pound boxes of Crushed Red pepper were distributed throughout the Northeastern United States. The product was not sold at the retail level or directly to consumers. Click on the following link to view a copy of the FDA Wholesome Spice Recall Release.

In a separate news release posted on the Rhode Island Department of Health website, David R. Gifford, Rhode Island's health director, noted that the recall “confirms that the source of the Salmonella was from outside of Daniele's manufacturing plants." According to additional reports, Wholesome Spice is currently working closely with FDA to determine how the contamination occurred.

In any event, manufacturers who may have purchased any of the recalled products are being urged not to use the products, and to recall any other products which may have used red pepper as an ingredient. Manufacturers with questions may contact Wholesome Spice via telephone at (718) 388-1549, Monday to Friday between 8:30-4:30pm EST.

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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.

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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.

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According to the FDA, Bao Ding Seafood of New York has issued a voluntary and precautionary recall of Boiled Horse Mackerel products because they have the potential to be contaminated with clostridium botulinum.

The processed products subject to the recall include Boiled Horse Mackerel packaged in a vacuum packed plastic bag, net weight 450g. The products were sold throughout New York State, and consumers should not use the product even if it does not look or smell spoiled. Click on the following link to view the FDA Recall Release.

The potential problem was discovered during a routine inspection and subsequent analysis of product by food lab personnel, which confirmed that certian fish had not been properly eviscerated prior to processing. To date, no illnesses have been reported in connection with the consumption of these products. Nevertheless, consumers who may have bought the recalled products are being advised to return them to the place of purchase.

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According to the FDA, Willamette Shelling has announced a recall of 114,350 pounds of shelled hazelnuts. To date, additional companies affected by the recall include Willamette Filbert Growers, Kunze Farms, and numerous other distributors and grocers nationwide.

The Willamette Shelling hazelnuts subject to the recall were shelled at a facility (located in Newberg, Oregon) for distribution to numerous down-stream hazelnut processors. Specifically, shelled hazelnuts distributed by the company were sent to various Oregon processors, along with a Canadian processor, and then further distributed by those firms.

All products subject to the initial Willamette Shelling recall were packed in 25 and 50 pound corrugated boxes, and marked with lot code numbers 296091A, 299091A, 300091A, VH3696BO, and 310091A. The corrugated boxes were also marked with the following brand names: Kunze Farms, Evonuk Oregon Hazelnuts, Canadian Hazelnuts, and Firestone Farms. It is important to note, however, that Willamette Shelling unshelled hazelnuts are not affected by this recall. Click on the following link to view a copy of the FDA Recall Releas (Willamette Shelling).

Willamette Shelling announced the recall immediately after learning that routine, random sampling confirmed positive for Salmonella in one of its hazelnut production lots. In turn, in an abundance of caution, and to ensure consumer safety, the company elected to voluntarily recall all shelled hazelnuts processed at its facility between October 12, 2009 and November 25, 2009. Thus, any hazelnut processors who used potentially recalled product are urged to return the product directly to Willamette Shelling.

As noted, the additional following downstream companies affected by the recall included Willamette Filbert Growers (of Newberg, Oregon), Kunze Farms (of Dayton, Oregon), and additional distributors and grocers located in Colorado:

• Contemporaneous with the announcement of the original recall, Willamette Filbert Growers announced its own recall of 29,861 pounds of potentially affected Shelled Hazelnuts and Shelled Organic Hazelnuts. The Willamette Filbert products subject to the recall were packed in 25 pound corrugated boxes, labeled with “Willamette Filbert Growers” or “Meridian Organic Hazelnuts,” and lot code numbers 289091A and 311091A. The hazelnuts were distributed in Oregon and California through wholesale distributors and for direct delivery. Here too, unshelled hazelnuts are not subject to the recall. Click on the following link to view a copy of the FDA Recall Release (Willamette Filbert).

Any customers who may have purchased Willamette Filbert Shelled Hazelnuts or Meridian Organic Hazelnuts are being urged by the company to return the product to the place of purchase for a full refund. Consumers with questions may contact Ben Mitchell at (503) 538-9256.

• Following the original recall announcement by Willamette, Kunze Farms also announced its own recall of 32,950 pounds of potentially affected hazelnut kernels. The Kunze Farms product was packed in 25 pound cartons, under the product brand name of Kunze Farms, ‘Select Shelled Hazelnuts’ Dayton, Oregon, with the code numbers 289091A or 299091A. The hazelnut kernels were distributed to several different processors and wholesaler’s in the following areas: Dayton, Oregon; Milton-Freewater, Oregon; Hauppauge, New York; Mesa, Arizona; Cottonwood, Arizona; Seattle, Washington; Ogden, Utah; San Antonio, Texas.; and Parker, Colorado. Click on the following link to view a copy of the FDA Recall Release (Kunze Farms).

In turn, consumers who may have purchased Kunze hazelnuts affected by the recall are being urged by the company to return the products to the place of purchase for a full refund. Consumers with questions may contact Kurt Kunze at (503) 864-2102.

The Colorado Department of Public Health has also identified additional companies that have been affected by the recall. Click on the following link to view the CDPH Hazelnut Recall Notice.

In Colorado, the recalled hazelnuts were sold by Mountain Man Nuts and Fruits Co. via the Internet, to numerous stores and sales distributors. Additionally, the product was distributed in Colorado to a variety of retail firms for bulk sale, including Whole Food Markets, Ft. Collins Food Co-op, Mountain Mama Natural Foods in Colorado Springs, and Healthy Solutions, in Denver.

All firms receiving recalled product have reportedly been notified, and the product is being pulled from shelves. Currently, the following additional products and lot codes are being recalled:

• Filberts, 289091A, 299091A;

• Natural Mixed Nuts, 32009, 33809;

• Fancy Mixed Nuts, 8- and 16-oz. bags, 30909, 31309, 31709, 32009, 32309, 32909, 33509, 33709 34209, 34309, 34809, 34909 35009;

• Choice Mixed Nuts, 16-oz. bags, 31309, 32709, 33609, 34909;

• Dry Roast Mixed Nuts,16-oz. bags, 30909;

• Sweet Simplicity™ Trail Mix, 32909;

• Mountain Jubilee® Trail Mix, 8- and 16-oz. bags, 31309, 32409, 33709, 34909;

• Cinnamon Almond Appleanche™ Trail Mix, 31009;

• Fancy Mixed Nut Gift Packs, 1.75 lb., all product, except 35009; and

• Fancy Mixed Nut Gift Packs, 1 lb., all product, except 35009.

According to the CDPH, products with these lot codes may also have been used as a component in certian gift baskets, including the 12 Tastes Basket, Bounty Basket and Half-Pound Sample Baskets. Moreover, given the potentially wide distribution of recalled product, additional recalls will likely be announced.

DECEMBER 23, 2009 UPDATE:

In addition to the specific recalls identified above, additional downstream companies have announced or expanded recalls of potentially affected products.  These include the following:

• Evonuk Oregon Hazelnuts:  View the FDA Recall Release.

• Harry and David:  View the FDA Recall Release.

• Whole Foods Market®:  View the FDA Recall Release.

• Burnt Ridge Orchards: View the FDA Recall Release.

• Market of Choice:  View the FDA Recall Release.

• Mountain Man Nut & Fruit Co.®:  View the FDA Recall Release.

Finally, it is important to note that, to date, there have been no reports of illnesses associated with the consumption of these products. Nevertheless, Willamette has ceased production and is working closely with FDA to investigate the issue, and will resume production and shipment  when any potential concerns have been resolved.

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Today, more than 15 percent of the food consumed in the United States is imported from foreign shores.  In turn, more and more cosumers are begining to question what is, and what isn't, being done to ensure the safety of foreign food product imports. 

In response, the Department of Homeland Security ("DHS") recently announced the creation of a new group, called the Import Safety Commercial Targeting and Analysis Center ("CTAC"), designed to enhance federal efforts to ensure the safety of imported foods.

Recommended by President Obama’s Food Safety Working Group, the new center will be staffed with about 30 members, will operate under the direction of Customs and Border Protection ("CBP"), and will receive direct assistance from numerous additional governmental agencies, including the FDA, EPA and CPSC. As one of CBP's six commercial targeting centers in the United States, the CTAC will target shipments of imported cargo, including food, for potential safety violations.

"In addition to guarding against terrorism and crime, securing our borders and facilitating legitimate trade involve ensuring the safety of imported [food] products," said DHS Secretary Napolitano. "This new targeting center will enhance the inspection of goods entering our country by centralizing and strengthening federal efforts to protect U.S. consumers."

Agriculture Secretary Tom Vilsack and HHS Secretary Kathleen Sebelius also backed the initiative. “With so much food coming from abroad, we must do all we can to ensure that it conforms to the same safety standards as our own food safety systems,” said Sebelius. “The new CTAC announced today is an important step toward the type of collaboration necessary to ensure that Americans have access to a safe and healthy food supply,” added Vilsack.

As part of its collaboration with CBP, FSIS will also extend its enforcement efforts to target ineligible imports, and investigate suspicious shipments based on manifest information filed prior to the arrival of goods at U.S. ports.

Ultimately, the new facility, which will be located adjacent to CBP's Office of International Trade in Washington, will strive to enhance the safety of foreign food product imports by promoting the three core principles announced by the Food Safety Working Group: Prevention, Surveillance and Response.

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According to the FDA, Unilever has announced a precautionary and voluntary nationwide recall of all Slim-Fast® ready-to-drink (RTD) products in cans.

The products affected by the recall are packaged in paperboard cartons containing four, six or 12 steel cans that are 11 FL OZ (325 mL) each. Individual cans are also sold in certain retail outlets. The recall involves all Slim-Fast® RTD products in cans, regardless of flavor, Best-By date, lot code or UPC number. Click on the following link to view a List of Recalled Products.

No other Slim-Fast® products, including Slim-Fast® powdered shakes, meal bars or snack bars, have been affected by the recall.

The recall was initiated after the company conducted quality testing on Slim-Fast® RTD products in cans. Because possible issues involving Bacillus cereus, the company announced, in an abundance of caution, a precautionary recall of all RTD products in cans that are currently in distribution centers, on-shelf or in back rooms in retail outlets or in consumers’ homes. Click on the following link to view a copy of the FDA Recall Release.

It is also important to note that, to date, there have been no reports of any illnesses associated with the consumption of these products. And, although Bacillus cereus in some instances can cause diarrhea and nausea, the possibility of serious illness or other significant health consequences is remote. Nevertheless, the company working to identify and correct any potential processing issues, and plans to resume production once they have been fully addressed and corrected.

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According to the FDA, Timco Worldwide Inc. (based in Davis, California) has announced a voluntary recall of a limited number of Large Seedless Watermelons.

The Large Seedless Watermelons affected by the precautionary recall contain the “MelonUp!” sticker label, with a PLU (Price Look Up) # 4032 and UPC # 0 33383 40240 6. The watermelons were distributed to select grocers, wholesalers and processors in California and Texas. Click on the following link to view a copy of the FDA Recall Release.

Timco announced the recall immediately after learning that routine, random sampling by a distribution company confirmed positive for Salmonella. In turn, the company announced, in an abundance of caution, a recall of all potentially affected products.

It is also important to note that, to date, there are no reports of illnesses associated with the consumption of these products. Nevertheless, consumers who may have purchased watermelons in the markets noted above (with the MelonUp! label) are being urged by the company to return them to the place of purchase for a refund. In turn, consumers with questions, or who need additional information, are invited to contact the company at 1-530-757-1000 (press “4” for Food Safety).

As with all fresh fruits and vegetables, Timco also recommends that fresh melons be thoroughly washed and rinsed before cutting and/or consuming them.

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According to the FDA, Five Crowns Marketing (based in Brawley, California) has announced a voluntary and precautionary recall of select cantaloupes packed under the Majesty label.

The cantaloupes affected by the precautionary recall were packed in various sizes with and without individual “Majesty” stickers. All cartons carry the label "Majesty," and are further identified with lot numbers 198 2 or 198 3, and pack dates of Nov 4, Nov 6, and Nov 10. Additionally, the cantaloupes in the identified lots were harvested and shipped to wholesalers, retailers, and food service operators in the states of Alabama, California, Illinois, Michigan, Minnesota, New York, Ohio, Oregon, Pennsylvania, and Tennessee. Click on the following link to view the FDA Recall Release.

Five Crowns Marketing announced the recall immediately after learning that routine testing on a lot of cantaloupes packed on November 4, 2009 confirmed positive for Salmonella. In turn, the company announced, in an abundance of caution, a recall of all cantaloupe from the same lot.

It is also important to note that, to date, there have been no reports of illness associated with the consumption of these products. According to the company, most of the cantaloupes have likely already passed through the distribution chain. Nevertheless, the company continues to work with its customers to ensure that all of the potentially affected cantaloupes have been accounted for.

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An outstanding group of international food safety regulators, academics, industry leaders and top food safety lawyers are gathering in Beijing this week for a 2 day conference on food safety.

The Third Annual China International Food Safety and Quality Conference is designed to provide expert perspective on emerging industry trends impacting foreign food product imports, production and safety.

Speakers include Ge Zhirong, President, China Entry-Exit Inspection and Quarantine Association; Wang Yong, Minister, General Administration for Quality Supervision Inspection & Quarantine; David Tharp, International Association for Food Protection; Michael Pulch, European Commission to China, Bernard Kuhnle, German Federal Ministry of Food, Agriculture and Consumer Protection; Murray Lumpkin, FDA; Robert Charlebois, Canadian Food Inspection Agency; Art Liang, CDC and many, many more.

In turn, I will be speaking this year about the impact of food safety litigation in the United States on foreign food product production, imports and safety. Fellow food safety attorneys Bill Marler and David Ernst will offer additional perspective on food safety litigation at home and abroad.

More, of course, to follow.

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Following recent media coverage involving the regulation of our food supply, Agriculture Secretary Tom Vilsack issued a statement highlighting the continuing efforts of USDA to ensure that our food remains as safe as it can be. Click on the following link to view the USDA Statement.

“Over the last eight months since President Obama took office,” said Vilsack, “the USDA has been aggressive in its efforts to improve food safety, and has been an active partner in establishing and contributing to President Obama's Food Safety Working Group.”

"Protecting public health is the sole mission of the USDA Food Safety and Inspection Service. FSIS has continued to make improvements to reduce the presence of E. coli O157:H7 and the agency is committed to working to reduce the incidence of food-borne illnesses caused by this pathogen.

"Shortly after coming into office, the Administration created a high-level Food Safety Working Group to coordinate food safety policies, focus greater resources on prevention, and improve response to outbreaks. Since doing so, we have taken the following actions:

• Launched an initiative to cut down E. Coli contamination (including in particular contamination from E. Coli O157:H7) and as part of that initiative, stepped-up meat facility inspections involving greater use of sampling to monitor the products going into ground beef;

• Appointed a chief medical officer within USDA's Food Safety Inspection Service to reaffirm its role as a public health agency;

• Issued draft guidelines for industry to further reduce the risk of O157 contamination;

• Started testing additional components of ground beef, including bench trim, and issuing new instructions to our employees asking that they verify that plants follow sanitary practices in processing beef carcasses; and

• Designed the Public Health Information System (PHIS) in response to lessons learned in past outbreaks.

According to Vilsack, "the USDA is also looking at ways to enhance trace back methods and will initiate a rulemaking in the near future to require all grinders, including establishments and retail stores, to keep accurate records of the sources of each lot of ground beef."

"No priority is greater to me than food safety," said Vilsack, "and I am firmly committed to taking the steps necessary to reduce the incidence of food-borne illness and protect the American people from preventable illnesses. We will continue to make improvements to reduce the presence of E. coli 0157:H7."

Because there is no technology (with the exception of irradiation or cooking), however, to ensure that raw animal products can be made sterile, FSIS continues to remind consumers that thoroughly cooking raw animal products to an internal temperature of 160 degrees will destroy any pathogens that may be present, and will render the products safe.

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It's not www.defendingfoodsafety.com.  But, it may be a close second.

Numerous food safety improvement measures have been initiated in the United States this year. One of the latest, unveiled by the FDA, USDA and Department of Health and Human Services, is a food safety website. The website, www.foodsafety.gov will provide a broad variety of information relating to food safety, including recall information and food handling tips. It will include news and information from each of the governmental agencies including FDA, USDA and CDC responsible for overseeing food safety in the United States.

The site, which is described as a gateway to federal food safety information, provides a wide array of information and resources for consumers to utilize. Among the numerous tools available on the site, are food safety educational materials for download, information about pathogens, podcasts and also an “ask a question” link whereby a consumer can receive an answer to a specific question.. The food safety information is broken down by food groups. It is both easily navigable and readily accessible.

According to the Food Safety Working Group, the federal government will continue “to enhance www.foodsafety.gov to better communicate information to the public and include an improved individual alert system allowing consumers to receive food safety information, such as notification of recalls. Agencies will also use social media to expand public communications.”

Future plans include expanding the website to have mobile access and text alerts.

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According to the FDA, Muranaka Farms has announced a voluntary recall of 1005 cases of 60 count bunched Parsley because it has the potential to be contaminated with Salmonella.

The recall was trigged as a result of a voluntary sampling program conducted by the California company in cooperation with the FDA, which revealed that certain finished products could potentially contain the bacteria. Click on the following link to view the FDA Recall Release.

The specific products affected by the recall include 60 count fresh bunched parsley Lot Code 0023909. The products were shipped in a brown wax carton under the Muranaka Label with a parsley silhouette on the side. In turn, individual parsley bunches were banded using a red rubber band. The lot code 0023909 is on a sticker on the outside of the carton.

The affected products were distributed in the following 10 states: Arizona (30 cases), California (574 cases), Colorado (35 cases), Florida (60 Cases), Iowa (3 cases), Illinois (1 case), Missouri (7 cases), Tennessee (5 cases), Texas (278 cases) and Wisconsin (12 cases). These cases were distributed within both retail and foodservice outlets.

Because of Muranaka Farm's trace recall program the company was able to immediately determine which customers purchased the product in question. Muranaka's food safety protocols also ensure the company was able to determine the amount of cases harvested, the crew harvesting the product, and the field on which the parsley was grown and harvested. The company is continuing to work with the FDA to determine a potential cause.

It is also important to note that, to date, there have been no reported illnesses associated with the consumption of these products. Moreover, although the product is over two weeks old, and likely past its useable shelf-life, the company is nevertheless working diligently with customers to ensure that the products are fully accounted for and out of the supply chain.

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The FDA has announced a new tool it believes will help prevent future cases of food-borne illness – the Reportable Food Registry.

In 2007, former President Bush signed into law the Food and Drug Administration Amendments Act (Public Law 110-85). The Act, which amended the Federal Food, Drug and Cosmetic Act by creating a new section 417 (21 U.S.C. 350f), required the Secretary of Health and Human Services to establish a mandatory reporting registry for potentially dangerous foods. The stated purpose of the amendment was to provide FDA with “a reliable mechanism to track patterns of adulteration in food.” Implementation of the new law, however, was delayed while the FDA worked on developing an effective electronic reporting system.

Now that the Reportable Food Registry (“RFR”) is up and running, the mandatory reporting requirements have gone into effect. The new FDA rules apply to any company that is required to submit registration information to the FDA for a food facility “that manufactures, processes, packs, or holds food for human or animal consumption in the United States.” In turn, the rules extend to any food or animal feed regulated by the FDA, except for infant formula and dietary supplements which are covered by other regulatory requirements.

Under the new FDA rules, a food company is now required to alert the FDA – through the RFR Portal – within 24 hours of becoming aware it has sold and shipped a "reportable food." According to the FDA, a reportable food is defined as any food product that has a “reasonable probability” of causing health problems or death in humans or animals.

As explained by the FDA, some examples of reasons a food may be reportable include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.

In turn, once a food company discovers a problem with a product it has shipped, and submits a report through the RFR, it will be required to cooperate with the FDA to help determine the cause and prevent potential health problems. Companies will also be required to notify relevant suppliers and distributors of any potential safety issues, be ready to submit further data and tests to the FDA, and initiate their own investigation if the problem is thought to have originated internally.

Notably, however, the new reporting requirements apply only to products that have been shipped into commerce. For this reason, a food company is not required to report a problem to the FDA if it discovered the problem before a food product was shipped, and then corrected the problem or destroyed the food.

Although Michael Taylor (senior advisor to the FDA commissioner) stated that industry should be able to easily judge when a food product is “reportable” under the new guidelines, the Grocery Manufacturers Association quickly responded raising concerns over what it called “questions and ambiguities” in the registry. In turn, the GMA urged the FDA to remain flexible, and to help work through potential ambiguities, as the new regulations go into effect.

For additional information on the registry and reporting requirements, please visit www.fda.gov/ReportableFoodRegistry

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According to the FDA, Melon Acres has announced a voluntary and precautionary recall of cantaloupes because they may have the potential to be contaminated with Salmonella.

The cantaloupes affected by the voluntary recall were distributed through Farm-Wey Produce (of Lakeland, Florida) between August 13 and 14, 2009. The cantaloupes, identified as 41 MG 10, Bin Numbers 4753-4980, were shipped to Aldi's in Greenwood, Indiana and to Meijer in Lansing, Michigan, Newport, Michigan, and Tipp City, Ohio. Click on the following link to view the FDA Recall Release.

The recall was issued following routine testing by the FDA on Tuesday, August 11, 2009, which revealed that a single sample (from twenty cantaloupes taken by the Agency) tested positive for Salmonella. The FDA reported the positive test to Melon Acres on Friday, August 21, 2009.

In turn, the FDA and Melon Acres worked together to identify the field in which the positive sample was grown. According to the company, no further shipments will be made from the source field. Additionally, on August 7, 2009, Primus Labs, a third party food safety auditing firm specializing in produce, inspected Melon Acres' fields and facilities regarding its food safety practices. Melon Acres received grades of excellent/good respectively, in this audit.

It is also important to note that, to date, there have been no reported of illnesses associated with the consumption of these products. Further, the company wishes to assure the public that stringent Food Safety Programs are in place at its shipping locations and fields, and is working closely with the FDA to identify the potential source of contamination.

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According to the FDA, Quesos Mi Pueblito has announced a voluntary recall of certian cheese products because they may have the potential to be contaminated with Listeria monocytogenes. Click on the following link to view the FDA Recall Reslease.

The specific products affected by the recall, with "sell by dates" from February 2, 2009 to the present, are as follows:

• LA FE OAXACA STRING CHEESE: [USP: 0 23545 40115 6] 14 oz. pack (plastic package);

• EL VIEJITO OAXACA CHEESE: [USP: 7 18122 18071 4] 14 oz. pack, 10 lb. ball (plastic package);

• MI PUEBLITO COTIJA/AñEJO: [USP: 0 24077 10221 4] vacuum packed in plastic wrap by specific weight (plastic wrapped);

• MI PUEBLITO CUAJADA FRESCA: [USP: 0 24077 10216 0] 14 oz. pack (plastic wrapped);

• MI PUEBLITO QUESO COLOMBIANO DE ARRIERO: [USP: 0 24077 10219] 1 / 8 oz. pack (plastic package);

• MI PUEBLITO QUESO MOLIDO: [USP: 0 24077 10211 5] 14 oz. pack (plastic package);

• MI PUEBLITO QUESO COTIJA TRIANGULO: [USP: 0 24077 10220 7] 14 oz. pack (plastic package);

• MI PUEBLITO QUESO FRESCO: [USP: 0 24077 100258] 14 oz. pack, 10 lb. ball (plastic package);

• MI PUEBLITO QUESO FRESCO DE RANCHO: [USP: 0 24077 10215 3] 14 oz. pack (plastic clam shell container, plastic wrap);

• MI PUEBLITO QUESO CASERO: [USP: 0 24077 10222 1] 14 oz. pack (plastic clam shell container, plastic wrap);

• MI PUEBLITO QUESO OAXACA: [USP: 0 24077 10224 5] 14 oz. pack (plastic package);

• MI PUEBLITO REQUESON: [USP: 0 24077 10200 9] 15 oz. pack (plastic package); and

• MI PUEBLITO SERRANO: [USP: 0 24007 10200 0] 16 oz. pack (plastic package).

The recalled products (produced by the company in Passaic, New Jersey) were distributed through Puebla Foods, Inc. to retail stores and wholesalers in New Jersey, New York, Maryland, Delaware, and Virginia. Click on the following link to view the affected Product Labels. The potential problem was discovered through routine sampling and analyses conducted by the New Jersey Department of Health.

It is also important to note that, to date, no illnesses have been associated with the consumption of these products. Nevertheless, consumers who have purchased these products are urged to return them to the place of purchase for a full refund.

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According to the FDA, SUPERVALU has announced a voluntarily recall of frozen Culinary Circle Gourmet Macaroni and Cheese products because they may have the potential to be contaminated with listeria monocytogenes.

The products affected by the recall include Culinary Circle Gourmet Macaroni and Cheese (a frozen product) sold in 38 oz. packages with a UPC# of 41130 38704. The products were sold at numerous SUPERVALU-owned stores including Acme, Albertsons, biggs, Cub Foods, Farm Fresh, Hornbacher’s, Jewel-Osco, Lucky, Shaw’s/Star Market, Shop ‘n Save, and Shoppers Food & Pharmacy. Click on the link to view the FDA Recall Release.

It is important to note that there have been no reported illnesses associated with the consumption of these products. Rather, the possibility for contamination was identified through routine microbiological sampling at the manufacturing facility.

In turn, because the safety of its customers is a top priority of the company, SUPERVALUE has elected, in an abundance of caution, to issue a precautionary and voluntary recall of these products.  Health officials also remind consumers that thoroughly cooking all raw foods will typically destroy any pathogens that may be present, and render such products safe

Customers who have purchased the affected product can bring it back to their SUPERVALU-owned store for a full refund or exchange.

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Tanimura & Antle (located in Salinas, California) has announced a voluntary recall of various romaine lettuce products following a finding of Salmonella in a random sampe taken by the Wisconsin Department of Agriculture. Immediately after being informed of the positive test result, the company initiated comprehensive trace-back efforts, and was able to contact all customers within hours. Those buyers have been told to destroy the lettuce.

The recalled lettuce, which had been distributed to retail, foodservice and wholesale customers in 29 states, was harvested between June 25 and July 2, 2009. The specific products affected by the recall include cartons of bulk and wrapped lettuce with a lot code 531380. Click here to view a copy of the Company Press Release.

According to Tanimura & Antle, the affected products were distributed to the following states: Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Nebraska, New Hampshire, New Mexico, Nevada, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Wisconsin and Wyoming.

Chief executive officer Rick Antle stated that Tanimura & Antle practices strict food safety guidelines. Additionally, despite the lettuce being past its shelf life, he cited an "abundance of caution" in issuing the recall. "We will continue to review opportunities for improvement," Antle said. “Although the recalled product is well beyond the 14-16 day shelf life, we are voluntarily issuing this recall because we want to ensure that we minimize even the slightest risk to public health.”

To date, there have been no reports of illness associated with the lettuce. Moving forward, the company also stated that it will continue to update its website with more information. Consumers with questions, or who need information, may call Tanimura & Antle at 1-877-827-7388.

AUGUST 3, 2009 UPDATE:

On August 3, 2009, Tanimura & Antle expanded the geographic scope of its original recall to include product distributed to all 50 states.  Although the volume of cases from the single recalled lot (which is identified above) has not changed, the company recognizesd the possibility that some customers may have distributed the romaine in states beyond the original 29 -- thus, prompting the expansion. Click on the following link to view a copy of the Updated Recall Release.

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The FDA has announced a new regulation which it expects to prevent approximately 80,000 cases of food-borne illness (and 30 deaths) caused each year by Salmonella Enteritidis in eggs.

The final rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (74 FR 33030), requires manufacturers to employ additional preventive measures during the production of shell eggs in poultry houses, and mandates subsequent refrigeration during storage and transportation. Click on the follwing link to view a copy of the FDA Final Egg Rule.  According to the FDA, the implementation of such measures could potentially reduce the number of Salmonella infections from eggs by nearly 60 percent.

“Preventing harm to consumers is our first priority,” said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs. “Today's action will prevent thousands of serious illnesses from Salmonella in eggs.”

Salmonella Enteritidis can be found inside eggs that appear perfectly normal. Eggs in the shell can become contaminated on the farm, primarily because of infection in the laying hens. If the eggs are subsequently eaten raw or undercooked, the bacterium can cause illness.

The new rules requires that measures designed to prevent Salmonella be adopted by virtually all egg producers with 3,000 or more laying hens whose shell eggs are not processed with a treatment, such as pasteurization, to ensure their safety.

Producers with at least 3,000 but fewer than 50,000 laying hens must comply within 36 months after the rule’s publication. Producers with 50,000 or more laying hens must be in compliance with the rule within 12 months after its publication in the Federal Register.

Under the rule, egg producers must:

• Buy chicks and young hens only from suppliers who monitor for Salmonella bacteria;

• Establish rodent, pest control, and biosecurity measures to prevent spread of bacteria throughout the farm by people and equipment;

• Conduct testing in the poultry house for Salmonella Enteritidis. If the tests find the bacterium, a representative sample of the eggs must be tested over an 8 week time period (4 tests at 2 week intervals); If any of the four egg tests is positive, the producer must further process the eggs to destroy the bacteria, or divert the eggs to a non-food use;

• Clean and disinfect poultry houses that have tested positive for Salmonella Enteritidis; and

• Refrigerate eggs at 45 degrees Fahrenheit temperature during storage and transportation no later than 36 hours after the eggs are laid.

Egg producers whose eggs receive treatments such as pasteurization must still comply with the refrigeration requirements. Similarly, certain entities such as distributors, packers, or truckers holding or transporting shell eggs also must comply with the refrigeration mandates.

To ensure compliance, egg producers must also maintain a written Salmonella Enteritidis prevention plan and associated records documenting compliance. Producers (except those who have less than 3000 hens or who sell all their eggs directly to consumers) also must register with the FDA. In turn, the FDA will develop guidance and enforcement plans to help egg producers comply with the rule.

The FDA has estimated that the rule would provide $1.4 billion in annual public health benefits, at an annual cost of $81 million to the regulated industry, or less than 1 cent per dozen eggs produced in the United States.

The new rule is part of a coordinated strategy between the FDA and the FSIS. The FDA and the FSIS will continue to work closely together to ensure that egg safety measures are consistent, coordinated, and complementary.

In addition to the new safety measures being taken by industry, consumers can also reduce their risk of food-borne illness by following safe egg handling practices. The FDA reminds consumers to buy eggs that have been refrigerated, to make sure eggs in the carton are clean and not cracked, and to cook eggs (and any foods containing eggs) thoroughly.

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Mike’s Produce, Inc. (d/b/a. Kowalke Family Sprouts) has announced a voluntary recall of all Kowalke Family Sprouts Brand Alfalfa Products with sell-by dates from June 18, 2009 through June 30, 2009.  The recall was announced after the company received notification that a sprout sample (taken from a retail location) had tested positive for Salmonella. 

After being notified of the positive sample, Kowalke Family Sprouts (located in Los Angeles, California) promptly informed the FDA of its actions. It is not clear how Salmonella may have been introduced into the sprouts, and the company is cooperating fully with the agenciy's continuing investigation.

According to reports, Kowalke Family Sprouts met all FDA disinfection, processing, and pathogen testing guidelines. In addition, although the FDA tested for the presence of Salmonella on sprout growing equipment, food contact surfaces, walls, floors, and drains at the Kowalke Family Sprouts facility, all tests results were negative. Despite extensive efforts, the FDA found no Salmonella at the Kowalke Family Sprouts facility.

Even though all environmental samples were negative, and although the alfalfa sprouts tested negative prior to being shipped to retailers, the firm (given the positive retail finding – and, in an abundance of caution) decided to recall all sprouts from the potentially affected lot.

Kowalke alfalfa products are sold in 4 oz, 8 oz, 1 pound and 5 pound clear plastic, clam shell packages. Two other Kowalke products also contain alfalfa sprouts - the Dinner Salad in a 6 oz package and the Onion/Alfalfa Mix in a 4 oz package.

These products were sold to distributors in Los Angeles and to retail stores in Southern California, Nevada, and Arizona. It is possible, however, that the sprouts may have been transported to other states. Click on the following link to view the FDA Recall Release.

To date, no illnesses have been reported from these products.

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The President's “Food Safety Working Group,” chaired by the Secretaries of the Department of Health and Human Services (Kathleen Sebelius) and the Department of Agriculture (Tom Vilsack), was conceived in March 2009 to help modernize our food safety system. In turn, Vice President Biden, Sebelius and Vilsack, have now announced key findings of the Group.

Following numerous meetings, and imput from key stakeholders, the Working Group has recommended a new approach to food safety based on three core principles: (1) prioritizing prevention; (2) strengthening surveillance and enforcement; and (3) improving response and recovery.

"There are few responsibilities more basic or more important for the government than making sure the food our families eat is safe," said Vice President Biden. "Our food safety system must be updated – 1 in 4 people get sick every year due to food-borne illness, and children and the elderly are more at risk. I applaud the Secretaries of HHS and the USDA for tackling this problem head-on, and coming up with key recommendations to ensure the health and safety of our food supply and, with it, the American people."

"Instead of spending their time trying to get kids to eat healthier food, too many parents and families are worrying about whether their food is safe in the first place," said Secretary Sebelius. "In just the past few months since we began work with the Food Safety Working Group, we have seen recalls on everything from spinach to peanut products to now even cookie dough.” According to Sebelius, the Administration believes “that the current system just isn’t working for America’s families, and under the President’s leadership, we are taking action to keep our food supply safe and prevent outbreaks that can impact millions of Americans."

"There isn’t a single American that isn’t impacted by our efforts to protect the food supply," said Secretary Vilsack. "We owe it to the American people to deliver on President Obama’s bold promise to greatly enhance our food safety system, moving our approach into the 21st century, employing the best surveillance techniques available, and ensuring that we are doing all we can to prevent illness before it occurs."

In its announcement, the Working Group outlined specific steps designed to advance its three core principles:

• HHS and USDA are targeting Salmonella contamination by developing tougher standards to protect the safety of eggs, poultry, and turkey.

• To fight the threat of E. coli, USDA is stepping up enforcement in beef facilities and the Food and Drug Administration (FDA) is developing new industry guidance improving protections for leafy greens, melons, and tomatoes.

• The Obama Administration is building a new national traceback and response system including clearer industry guidance, a new unified incident command system, and improved use of technology to deliver individual food safety alerts to consumers.

• Finally, the Administration announced a plan to strengthen the organization of federal food safety functions, including the creation of new positions at key food safety agencies and a continuing oversight role for the Food Safety Working Group.

The Food Safety Working Group is chaired by Secretaries Sebelius and Vilsack, and participating agencies include the FDA, the FSIS, the CDC, the Department of Homeland Security, the Department of Commerce, the Department of State, the Environmental Protection Agency, and several offices of the White House.

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Defending food-borne illness cases throughout the country, we understand better than anyone the uncertianty surrounding recent reports that raw Nestle cookie dough may be the source of an ongoing nationwide E. coli O157:H7 outbreak. Although, historically, E. coli has been linked to outbreaks involving water, spinach, lettuce, alfalfa sprouts, fruit juices, salami, cheese, and raw (or, undercooked) meat, cookie dough has never been implicated.

Nevertheless, since March 2009, federal and state investigators have been attempting to identify the likely source of a nationwide E. coli outbreak which has affected about 66 people in 28 states. To date, about 25 individuals have been hospitalized.

Although the true source of the ongoing outbreak remains uncertain, health officials recently announced that a number of cases associated with the outbreak reportedly consumed raw Nestle Toll House cookie dough prior to the onset of their illnesses.

In Colorado, for example, of five cases recently linked to the nationwide outbreak, four reported eating raw cookie dough. Nevertheless, although such reports may suggest an association with a particular food, epidemiology alone (without the added benefit of microbiological confirmation in an implicated product) is often insufficient to determine the cause of an outbreak. For this reason, Alicia Cronquist, an epidemiologist with the Colorado Department of Health (“CDH”), stated further that, although we want consumers to be aware, "[w]e can't be certain that raw cookie dough is the source of these infections." Click on the following link to view the CDH Press Release.

Despite lingering uncertainty, these reports prompted an immediate response from Nestle. Noting that the safety of consumers is paramount, and although E. coli has not been isolated from any of its products, the company elected, in an abundance of caution, to issue an immediate, voluntary and precautionary nationwide recall of refrigerated Nestlé Toll House cookie dough products. In turn, Nestle spokeswoman Roz O'Hearn confirmed that "this has been a very quickly moving situation." O'Hearn highlighted further that, after learning of a potential problem, "the company took action in less than 24 hours." Click on the following link to view the Nestle Press Release.

Thus, as the investigation continues, both Nestle and health officials have asked consumers not to eat prepackaged refrigerated cookie dough. The precautionary recall includes refrigerated cookie bar dough, cookie dough tub, cookie dough tubes, limited edition cookie dough items, seasonal cookie dough and Ultimates cookie bar dough. It does not, however, affect any other Toll House products. Click on the following link to view the FDA Recall Release (and list of affected products).

While Nestle is working closely with the FDA to determine whether any of its products are indeed implicated, the Minnesota Department of Health (“MDH”) is testing products collected from retail stores and from ill consumers' homes. Currently, the MDH is investigating six cases with onset dates between May 3 and June 11. Click on the following link to view the MDH News Release.

Finally, it should be noted that, regardless of the ultimate source of the outbreak, consumers should never eat raw cookie dough. According to Carlota Medus, an epidemiologist with the MDH, “cookie dough, whether purchased in a tub from the store, or made at home from scratch, should not be eaten raw.”  This, of course, is because many raw products can potentially carry pathogens that might cause illness if improperly handled and prepared.  This is also why the labels on raw cookie dough clearly state that the products should always be baked before consumption.  When properly handled and prepared (and cooked to an internal temperature of at least 165 degrees), cookies make from raw dough are perfectly safe for consumption.

In any event, the safety and quality of its products, says Nestle, is a non-negotiable priority. For this reason, the company has apologized for any inconvenience caused by the precautionary recall.

And, until a source is conclusively determined, we of course will continue to provide updates on the continuing investigation.

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Following recent increases in public and media attention focused on food-borne illness, outbreaks and recalls, the House Energy and Commerce Committee has approved the Food Safety Enhancement Act of 2009. The proposed legislation is designed to enhance FDA food safety-related authority. 

The bill, H.R. 2749, passed the committee unanimously with an amendment that would exempt food production facilities and products regulated exclusively by the Federal Meat Inspection Act, the Poultry Products Inspection Act or the Egg Products Inspection Act.  The bipartisan bill, spearheaded by Chairman Henry Waxman (D-CA) and Chairman Emeritus John Dingell (D-MI), has received support from a broad coalition of consumer and public health organizations.

According to reports, the full House is expected to vote on the bill prior to the July 4 recess. Click on the following link to view a copy of the proposed legislation, as amended. If enacted, the bill would give the FDA new authority to create robust food safety standards, to establish rules for enhancing traceability, to increase inspections at high-risk facilities, to mandate food product recalls, and to enforce new penalties for violations of federal food safety requirements.

The legislation would also increase FDA funding to facilitate these efforts by requiring food companies to pay new annual registration fees of $500.

Although proposed food safety initiatives are also planned for debate in the U.S. Senate, these efforts, reportedly, may be stalled as a result of ongoing legislative efforts associated with proposed health care reform.

In any event, we’ll continue to report as the debate continues.

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Chang Farm, a Massachusetts company, has issued a voluntary recall of various bean and soy sprouts because of possible Listeria monocytogenes contamination. The sprouts were distributed to restaurants and retail stores throughout Connecticut, Massachusetts, New York, and New Jersey. Click on the following link to view the FDA Recall Notice.

According to the FDA, the contamination was discovered after a product sample (obtained from a retail store in New York) tested positive for Listeria. To date, no illnesses have been associated with the recalled sprouts.

The affected products, labeled as Chang Farm Brand soy sprouts and bean sprouts, are packaged in 10-pound bags (bulk) and 12-ounce plastic bags (retail). The soy sprouts have a “Sell By” date of May 23, 2009 or May 24, 2009, and the bean sprouts have a “Use By” date of May 23, 2009 or May 24, 2009.

All grocery stores, food services, and other retailers in Massachusetts, Connecticut, New York, and New Jersey are being advised to remove the recalled products from their shelves. In turn, consumers should either discard the products, or return them to the place of purchase.

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The House Energy and Commerce Committee has released a discussion draft of the Food Safety Enhancement Act of 2009 which, if passed, would require food manufacturers to pay an annual fee of $1,000 to fund increased inspections by the FDA.

Under the draft bill, high-risk food production facilities would be inspected by the FDA every 6 to 18 months, while low-risk facilities would be inspected every 18 months to three years. In addition to the annual inspection fee, the legislation would also require food manufacturers to pay for costs associated with any additional inspections triggered by food product recalls.  Click on the following link to view a Summary of the Food Safety Enhancement Act of 2009.

The chairman of the House committee, Rep. Henry Waxman (D-Cal.), stated that the proposed legislation is aimed at protecting the nation's food supply. According to Waxman, the new bill “recognizes that the hallmark of strong food safety legislation must be a shared responsibility for food safety oversight between FDA and industry.”

Although food manufacturers are not currently required to pay FDA inspection fees, current budget requests for the FDA include $260 million in new food safety initiatives, with about 35% of that anticipated to come from fees paid for directly by the food industry. While food industry groups strongly support the broad goals of the new proposed food safety measures, questions have been raised about the timing of new fees. According to industry representatives, new inspection fees are being proposed at a particularly bad time, given the slowing economy, for both food companies and consumers alike.

Among other things, the proposed legislation would also require food manufacturers to better trace the food they manufacture abd sell, and would give the FDA authority to issue mandatory recalls. The bill, if passed, would also strengthen criminal and civil penalties for any food companies that fail to comply with federal regulations.

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The U.S. Senate has officially confirmed Dr. Margaret Hamburg to lead the Food and Drug Administration (“FDA”). Hamburg, a bioterrorism expert, will be sworn in as the 21st commissioner of the FDA, and only the second woman to hold the post in 100 years of agency history. She was confirmed unanimously.

Hamburg’s first priority will be to help direct the development of a vaccine for the H1N1 flu. Notably, Hamburg has, in turn, promised to place greater emphasis on food safety. In the midst of numerous high-profile food-borne illness outbreaks, Hamburg stated she intends to shift the agency’s focus from chasing outbreaks once they occur to preventing them in the first instance. To accomplish this goal, Hamburg would also like to take advantage of the recent spike in food safety awareness by media, consumers and industry. As she puts it, “the growing consensus among experts and industry is that now is the time to shift to a food safety system that puts prevention first.”

We, of course, wish her the best as we all work, collectively, to enhance food safety.

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The President's “Food Safety Working Group,” chaired by the Secretaries of the Department of Health and Human Services (Kathleen Sebelius) and the Department of Agriculture (Tom Vilsack), was conceived to help modernize our food safety system. The group intends to foster “collaborative partnerships with consumers, industry and regulatory partners” and, through a transparent process, “build a food safety system to meet the challenges posed by a global food supply in the 21st century.” Click on the following link to visit the President’s Food Safety Working Group Website.

Last week, the Food Safety Working Group held its first “Listening Session” at the White House. Participants included numerous stakeholders representing a diverse range of organizations. Secretary of Agriculture Vilsack, who delivered the opening remarks, told participants that food Safety is of the highest concern for all of us. Although Vilsack noted that “Americans enjoy one of the safest food supplies in the world,” he also stated that more can should be done to improve food safety at all levels. Vilsack’s remarks are included below:

Welcome. Thank you for taking time to join us this morning.

Food Safety is of the highest concern for all of us here today. While Americans enjoy one of the safest food supplies in the world, we have witnessed too many outbreaks that make us worry that the food on our dinner plate or in our child’s lunch box will harm instead of nourish. This is not acceptable.

Today is the beginning of a significant and critical process that will fully review the safety of our nation’s food supply.

President Obama has pledged his full support in this matter and has charged the Food Safety Working Group with examining all aspects of food safety, be it meat or produce, fresh or frozen, whether it is imported, or produced domestically.

This issue will be one of USDA’s highest priorities. We are in the midst of reviewing all of our statutory authorities, as well as administrative and regulatory steps we can take, to ensure that our actions support public health and consumer safety to the fullest extent.

We have reviewed the Federal Meat Inspection Act, looked over our existing Hazard Analysis and Critical Control Point regulations, reviewed our enforcement authorities, and looked at how we collect data. While we are doing a good job, we at USDA can always do better.

I’d like to outline several specific challenges we need your input on:

•  Prevention. The key to a functioning food safety system is preventing foodborne illness. That means robust standards and sufficient authorities to prevent illnesses from occurring. Both FDA and USDA have embraced this principle and we must have a consistent approach.

•  Surveillance and Response. Our regulatory agencies must actively watch for disease outbreaks and take rapid action to ensure that we have effective and targeted recalls. Such recalls are in the interests of public health and the strength of industry sectors that might otherwise be tarnished by massive recalls.

•  As many people know first hand, in this economy we do not have unlimited resources. Nor can we simply pass higher food production costs onto struggling consumers. We must ensure that we are allocating our food safety resources effectively and efficiently. That means focusing the most attention on the products that have the most potential to cause harm.

•  The safety of a product should not be determined by where it originated. We live in a global community and by working more closely with our partners around the world we can make sure that the food the US is importing is as safe as the food we are exporting.

 •  All parts of the food safety system need to coordinate and work together in a seamless fashion. The FDA and USDA must do a better job of coordinating and I know that Secretary Sebelius and I will drive our agencies to improve coordination.

•  Industry, government, and consumer: each of us brings a piece of the puzzle. We can only solve this if all pieces are represented. It is time for us to set aside past frustrations, collaborate, and move forward together.

Finally, we need to develop a way to measure our success. I am confident that by working together, we will make improvements to the safety of our food supply. But we need a way to track our progress both in the short and long term, so that we do not settle for merely okay, but continually strive for improvement. Lives are at stake and good is simply not good enough.

Thank you again for joining us today.

The Secretary also thanked the participants’ mutual commitment to food safety, highlighted the Administration’s broad support for the modernization of food safety initiatives, and pointed to new and enhanced coordination between HHS and USDA to support this goal.

ViIsack also challenged government, industry and consumers to work more closely to improve food safety. This is good advice.

In the end, we all shoulder responsibility (whether producing or preparing food) to ensure that the meals we serve to our families are, indeed, as safe as they can possibly be.

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The Grocery Manufacturers Association ("GMA") has announced new, wide-ranging industry initiatives designed to improve the safety and security of our nation’s food supply. The initiatives, geared toward better food-borne illness prevention and response, are outlined in Prevention, Partnership and Planning: Supply Chain Initiatives to Improve Food Safety. The new initiatives include:

• Product Recall Modernization: 

Enhanced communication is the best way to ensure that food products, when recalls are announced, can be identified and removed from the marketplace as quickly as possible. Thus, the Food Marketing Institute ("FMI") and GS1-US, with the support of GMA, have developed and launched a new, electronic, Web-based product recall portal designed to facilitate the rapid and accurate flow of information between manufacturers and retailers during product recalls. GMA plans to participate closely with FMI and GS1-US to expand the use and capability of this recall communication tool.

• Accredited Third Party Food Safety Audit Certification:

Third party audits are an important part of America’s food safety net. To ensure rigor and integrity in third party certification, policymakers and industry leaders will be encouraged to engage auditors employed by certification bodies accredited to international standards by recognized organizations such as the American National Standards Institute ("ANSI"). ANSI is widely respected as the recognized accrediting body for conformity assessment systems in the U.S., and is recognized by the federal government as well as internationally.

In addition, GMA plans to work with its public and private partners, including FMI, to facilitate the implementation and recognition of certification systems. By increasing the number of well-qualified auditors, and developing universal food safety auditing criteria, industry leaders and policymakers will likely be better able to ensure that auditors are competent to review a particular facility. This should also discourage duplicative audits, reduce auditing costs, and encourage wider use of third party certification/audits throughout the food industry. Ultimately, it is anticipated that wider use of third party certification/audits can and will reduce the risk of food-borne illnesses.

• Modernization and Implementation of Good Manufacturing Practices (GMPs) for Food:

The FDA is currently working on updating and issuing Good Manufacturing Practices (GMP) regulations for food, which can be a critical component of any food safety system. Once the FDA regulations are updated and issued, GMA plans to provide industry-wide training and education to ensure rapid and wide-spread adoption of the new and updated GMPs.

According to Pamela G. Bailey, GMA president and CEO, “[w]e want consumers and policymakers to know that we are vigilant when it comes to product safety and consumer protection. We are stepping up to the plate, taking responsibility and developing innovative reforms to improve the safety of our products.” Bailey hopes the initiatives, coupled with proposed FDA food safety reforms, “will significantly reduce the number and type of food recalls, and strengthen our overall food safety system.”

In addition, explains Bailey, “we are developing enhanced food safety education and training for member and non-member companies, assessing and enhancing our crisis management capability, and expanding our ability to communicate during product recalls to ensure we are doing our part to protect consumers.”

Thus, once again, GMA has demonstrated its commitment as a food safety leader, working closely with stakeholders from the entire supply chain to develop comprehensive food safety solutions that will not only improve the safety of our food, but will also enhance the confidence of our consumers.

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As the FDA works to protect and promote the public health, it is requesting $3.2 billion as part of it's fiscal year (FY) 2010 budget. The request represents a 19% increase over the current FDA budget. Click on the following link to view a summary of the FDA Proposed Budget.

Notably, the FDA has asked for an additional $259.3 million to fund a new food safety initiative. The goal of the new initiative, “Protecting America’s Food Supply,” is to better prevent intentional and unintentional contamination of foods through risk-based prevention and verification. The initiative, as proposed, would focus on foreign and domestic sources of ingredients, components, and finished products at all points in the supply chain.

In addition, the FDA also proposes to collect a total of $94.4 million in new user fees from the registration of food facilities. It is anticipated that the additional fees will enable the FDA increase routine inspections, while at the same time conducting additional inspection for those facilities that fail to meet the FDA’s safety standards.

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The source of the multi-state Salmonella Outbreak linked to fresh alfalfa sprouts has likely been determined.

According to reports, the Salmonella strain implicated in the outbreak likely originated from seeds sold by the Caudill Seed Company of Louisville, Kentucky. In turn, Lyle Orwig, a company spokesman, stated that the offending seeds were imported by Caudill from Italy. As reported previously, Caudill has withdrawn all seed batches with six-digit lot numbers starting with “032”; the recalled seeds are packaged in 50-pound white bags marked with a white or yellow label.

Although testing did not reveal any Salmonella at Caudill’s facilities, Orwig reports that, “what [the FDA] has said to us, is the cases all led to sprouts, from multiple growers, and the common link is seeds.”  Seeds, anyway, from Italy...
 

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Working closely with the FDA, KLEEN-PAK FOODS refined its spinach recall, originally announced yesterday, to include spinach products distributed to Minnesota. The precautionary recall was announced following the discovery of Salmonella in limited product samples during routine testing.

The precautionary recall involves 10 ounce and 1 pound packages of fresh spinach distributed in retail stores and food wholesalers in Wisconsin, the Chicago area, and Minnesota. The products are marked with a use by date of 4/29, 4/30, and 5/01.

No illnesses have been reported, and KLEEN-PAK is continuing to work closely with the FDA to determine the original source of the potential contamination.

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As pistachio recalls continue to expand, Setton Pistachio of Terra Bella, Inc. (“Setton”) has issued a clarification to wholesale customers regarding the identification codes for wholesale bulk pistachio products originally recalled on April 6, 2009. The clarification does not concern product codes on retail products sold to consumers (search for recalled products using the FDA Pistachio Recall database found on the left-hand side of our blog).

The April 6 voluntary recall included all roasted shelled pistachios and roasted in-shell pistachios from the 2008 crop (and a small amount from the 2007 crop that was packaged alongside the 2008 crop) due to potential contamination with Salmonella. The recall also included raw shelled pistachios from the 2008 crop (and a small amount from the 2007 crop that was packaged alongside the 2008 crop) that were not subsequently roasted prior to retail sale. Setton’s raw in-shell pistachio shipments were NOT affected by the recall.

For bulk packages received by wholesale customers, products with either "7" or "8" as the 4th digit of the FMO number, and packaged between Julian dates 245 through 366 and 001 through 084 and shipped after September 1, 2008, are included in the recall. Thus, wholesale customers should check their stocks to determine if they have any of the affected products on hand.

If wholesale customers do have products covered by the April 6 recall, they should discontinue distributing them and contact the Company at (559) 535-6050 to make arrangements for the return or appropriate destruction of the affected products. If recalled products were distributed to other firms that further mixed, repackaged or distributed the bulk products, those customers should be informed of the recall, and should be directed to contact the FDA.

A list of pistachio products NOT affected by the ongoing recalls can be found at www.pistachiorecall.org.

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The answer, I suppose, depends upon who you ask.

With increased population, improved governmental outbreak surveillance, expanding media coverage, more public awareness, better attentiveness by healthcare professionals and increased frequency (along with substantial improvements) in testing, we might be justified to expect that the numbers of confirmed food-borne illnesses would be climbing like an uncontrolled fever. Nevertheless, according to a recent report issued by the CDC, the incidence of food-borne illnesses over the last three years has actually hit a “plateau.”

The findings are from 2008 data reported by FoodNet, a collaborative project of CDC, FSIS, the FDA and 10 separate states. Click on the following link for a copy of the CDC Report. According to CDC findings, incidence rates in 2008 for Campylobacter, Listeria, E. coli O157:H7, Salmonella, Shigella and other pathogens did not change significantly when compared to the previous three years (2005-2007). Moreover, significant declines since 1996 were reported in the incidence rates involving numerous, other food-borne infections.

Despite these findings, Robert Tauxe, deputy director of CDC's Division of Food-borne, Bacterial and Mycotic Diseases, suggested that we may have “reached a plateau in the prevention of food-borne disease.” In turn, David Goldman, assistant administrator of FSIS, indicated he was “concerned about the lack of progress in reducing the incidence of food-borne illness."  Click on the following link to learn how food-borne illnesses are tracked.

Has prevention really hit a plateau? Or, could the total number of illnesses be falling? Despite dozens of feverish outbreaks (and thousands of reported illnesses) recently associated with a long list of previously never-mentioned foods (such as produce, pot pies and peanut butter), the numbers of most food-borne illnesses (according to the CDC) have been holding firm. Although it might be easy to interpret such studies at face value, the real answer (lurking somewhere in the report’s constituent ingredients) might be far more complex.

Many will admit that, in years past, given considerable limitations in surveillance, testing and reporting, a large percentage of total illnesses simply went unreported. Given better public awareness and recent strides in our ability to detect and identify a greater number of food-borne illnesses and outbreaks, the lack of any perceivable increase in the CDC numbers could actually – in my humble view – represent a decline in total cases.

So, are food-borne illnesses declining, increasing or holding firm? While I doubt (and, there is no evidence) that the incidence rates for food-borne illness are on the rise, there are plenty of reasons to believe that we may have started – at the very least – to get this fever under control.

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Nuts. Following one of the largest food recalls in history (involving peanut products distributed by PCA), the pattern may be repeating. Setton Pistachio of Terra Bella, Inc. (in California), is expanding its earlier recall of 2,000,000 pounds of pistachios to include ALL pistachios produced in 2008.

That’s a lot of pistachios. Setton, reportedly, is the second largest pistachio distributor in the nation.

As the FDA and the California Department of Public Health continue to investigate Salmonella contamination in pistachios, Setton voluntarily expanded its March 30, 2008 recall to include all lots of roasted in-shell pistachios and roasted shelled pistachios produced from nuts harvested in 2008. The Company is also recalling all raw shelled pistachios from the 2008 crop that are not subsequently roasted prior to retail sale.

Because the pistachios were sold to numerous downstream customers, and used as ingredients in a wide variety of foods, the expanded recall will likely affect many additional products, and is expected to result in numerous additional recalls. Click on the following link for a searchable database of recalled products. This database is updated continuously by the FDA, and will likely grow as potentially affected products are identified and new recalls are announced.

In the meantime, the FDA is advising wholesalers, retailers, restaurants and food service establishments not to sell or serve any pistachios (or pistachio-containing products) until the original source of the pistachios can be determined. Companies should check with their suppliers to determine whether the source of the pistachios is Setton. Additionally, consumers should not eat pistachios or food products containing them (such as pistachio bakery goods and pistachio ice cream) until they determine that the products are not affected by the recall. Visit the following link for a list of those products NOT believed to be affected by the current recalls.

As noted, the recalls triggered earlier this year by investigations into PCA were some of the largest in history. Thousands of products and hundreds of companies were affected. In turn, as the current pistachio investigation continues, we will wait patiently to see whether, and to what extent, pistachios can distinguish (or, at the very least, unstick) themselves from peanut butter . . . 

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Food safety has long been a battle fought on multiple fronts. Once again, the principle proves true. As we continue to report on the absence of effective food safety laws abroad, our colleagues here at home are working feverishly to improve the effectiveness and efficiency of our own food safety system.

Is it possible, some ask, that all federal food safety responsibilities might be integrated into a single food safety agency? Although not likely in the very short-term, it would seem, at the very least, that the table is being set. As the search continues for new solutions to new food safety challenges, Trust for America's Health, along with the Robert Wood Johnson Foundation, released a report advocating significant changes to our national food safety system. The report, Keeping America's Food Safe: A Blueprint for Fixing the Food Safety System at the U.S. Department of Health and Human Services, outlines various weaknesses in the current system, and proposes, among other things, numerous improvements to the food safety functions of the  Department of Health and Human Services (“HHS”). In essence, the report advocates (as a first step) the creation of a new, stand-alone food agency within HHS.

Currently, the Food and Drug Administration (“FDA”), an agency within HHS, has responsibility for regulating the safety of drugs, medical devices and many foods. Although the United States Department of Agriculture, through its Food Safety and Inspection Service (“FSIS”), is responsibile for all meat, poultry and egg products sold in interstate commerce, the FDA regulates the safety of virtually all other foods (Learn how our food is currently regulated). To view the current, rather confusing, organizational structure of the FDA, click on the following link :

To increase efficiency (and decrease confusion), the new report urges Congress to quickly create a stand-alone Food Safety Administration (“FSA”) within HHS. Conceptually, the proposal would effectively split the FDA into two seperate agencies, each operating on the same plane - one devoted to food and the other devoted to drugs and medical devices. While the FSA would be responsible for regulating food safety, the drug and device sections of the FDA would become a separate agency called the “Federal Drug and Device Administration.” According to the report, a stand-alone food agency would fix the following key weaknesses under the current  structure:

• Inadequate leadership, prioritization, and coordination within FDA: No FDA official whose full-time job is food safety has line authority over all food safety functions. FDA's three major food safety components are managed separately, hampering efforts to effectively prevent disease outbreaks.

• Inadequate technologies and inspection practices: Current laws and practices are antiquated. Existing laws date back to 1906 and 1938, and policies are disproportionately focused on monitoring food after it has been produced, instead of trying to prevent and detect problems throughout the entire production process. And, there is no system in place to keep inspection practices up-to-date with the constantly modernizing food production technologies and practices.

• Inadequate staffing and resources: The FDA's Science Board found the agency is chronically underfunded. While the U.S. Government Accountability Office reports the turnover rate in FDA science staff in key areas, including food safety, is twice that of other government agencies.

• Inadequate inspection of imports (my favorite): Only one percent of imported foods are currently inspected, even though approximately 60 percent of fresh fruits and vegetables and 75 percent of seafood Americans consume is imported.

A stand-alone food safety agency such as the FSA would also, according to the report's authors, result in integrated and accountable senior leadership, integrated public health and science functions, and integrated compliance and enforcement programs. Click here (or on the picture to the right) to view the proposed organizational structure of a new FSA.  Ultimately, according to Risa Lavizzo-Mourey, president and CEO of RWJF, the proposal contained within the report is needed to ensure that "food safety [becomes] a priority on the prevention menu." 

Notably, in addition to the significant proposed changes to the fundamental structure of FDA, the report advocates (as a second step) potential future changes to FSIS and other agencies as well. Although FSIS in the short-term would likey continue to operate within the USDA as a separate agency, the report ultimately recommends that all current federal food safety functions (including FSIS responsibilities) should eventually be integrated into a single food safety agency. Thus, although the proposed immediate changes to the FDA will likely garner the most attention as the report is studied and considered, pointed advocacy for a single food safety administration (for all federal food regulatory functions) will likely follow.

In any event, as part of its vision, the report also recommends that a spot at the table be cleared (assuming a new food safety agency is created) for a single Food Safety Czar. We, of course, will wait for a response from Congress and the Obama Administration before we offer our comments on potential candidates . . .

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As industry continues to announce recalls of peanut butter products affected by the ongoing Salmonella Typhimurium outbreak, Congressman Waxman held hearings focused on shortcomings in the third-party food safety audits perfomed on behalf of the Peanut Corporation of America (“PCA”). The hearings were triggered after the American Institute of Baking (“AIB”), a private auditing company hired by PCA, was accused of failing to identify various sanitary problems during food safety audits of PCA's facility. Click on the link to view a copy of Congressman Waxman's Opening Remarks.

On March 5, 2009, Michael Moss and Andrew Martin of the New York Times were the first to critique the AIB audits in their article, “Food Safety Problems Slip Past Private Inspectors.” We similarly reported about various inconsistencies found in AIB's reports involving PCA’s plants. On March 27, 2008, for instance, an AIB Food Safety Audit gave PCA credit for developing and implementing a HACCP program “for all processes and product lines.” On April 29, 2008, however, a NSF Cook & Thurber Audit found “[no] documented . . . Hazard Analysis for each of the process steps.”

During the hearings, held by the House Energy and Commerce Subcommittee on Oversight and Investigations, it was also revealed that at least one food company, Nestle USA, used its own inspectors to audit PCA’s facilities. Following a 2002 Nestle Audit, the company concluded that PCA failed to meet its minimum requirements for suppliers. In turn, Nestle elected not to purchase peanut butter products from PCA. In a separate 2006 Nestle Audit of PCA’s Plainview, Texas facility, the company once again concluded that PCA failed to satisfy its food safety standards. While Nestle’s own audits identified numerous key food safety and sanitary issues in this facility, AIB in 2008 awarded PCA a certificate for "superior quality” following its own audit of the plant:

As we reported previously, PCA voluntarily closed its Plainview facility in February 2009 (only months after this certificate was issued), after governmental investigators discovered numerous sanitary issues existing in the plant. As a result of its own, continuing investigation, Texas health officials eventually ordered a recall of all products ever produced at the facility since it opened in March 2005.  Click on the link to view photos of the insanitary conditions of PCA's facilities.

Many companies that purchased peanut butter from PCA, of course, relied upon the inspections and conclusions of auditors like AIB. Kellogg, one of the companies which relied upon such third-party reports, lost $70 million after having to recall millions of packages of peanut butter crackers manufactured using PCA raw materials. In turn, David Mackay, Kellogg’s chief executive officer, recently joined the growing ranks of responsible food companies seeking tighter food safety laws.  Click on the link to view a copy of Mackay's Statement.  Also providing statements were Martin Kanan (President and CEO of Kanan Enterprises, Inc. d/b/a King Nut), and Heather Isely (Vice President of Vitamin Cottage Natural Foods).  On January 6, 2009, Salmonella was isolated from King Nut peanut butter manufactured using raw materials from PCA's Blakely, Georgia facility.  As recalls of King Nut peanut butter were announced, the source of the pathogen was quickly traced to PCA.  In turn, Vitamin Cottage peanut butter products, made from raw materials from PCA's Plainview, Texas facility, were also found to contain Salmonella.

During testimony today, the committee also released numerous emails exchange before and during the ongoing recalls. In one email, written before the source of the outbreak was identified, Pete Hatfield (an AIB Auditor) tells Sammy Lightsey (a PCA plant manager) that he’s “lucky” Hatfield is performing his annual food safety audit. Click on the link to view the Lightsey email.

In a second email, written as the source of the emerging outbreak was discovered, Stewart Parnell (the President of PCA) tells Joe Valenza (the Vice President of King Nut) that he “[was] sure it's something we did." Recognizing that recalls could not be avoided, Parnell concludes: "now my heart is really in my throat.  I think I'm going to church tonight." Click on the link to view the Parnell email.

In the third email, written as hundreds of recalls had already been announced, NSF representatives discuss the concerns raised by the AIB audits, the lack of micro data made available by PCA to auditors, and the potential implications for third-party auditing firms. Click on the link to view the NSF / Slawinski email.

Debate has begun and will surely continue regarding the quality of third-party food safety audits. Although most audits are valuable, and play an important role in our food safety system, we trust that, moving forward, all auditors, and the companies that rely upon their conclusions, will not repeat the mistakes of a select few.

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Over the last decade, there have been numerous attempts to reform our food safety laws. As our ability to identify food-borne illnesses and outbreaks continues to improve (special thanks to the CDC, PulseNet and OutbreakNet), at least some weaknesses that were rarely, if ever, considered are now being found. Thus, although most meals consumed in this country remain perfectly safe, the recent peanut butter recalls have those advocating the need for additional checks and balances, at least for certain segments of industry, finding growing support.

Prompted by the recent recalls, lawmakers have proposed revised food safety legislation – the new FDA Food Safety Modernization Act -- which would give the FDA additional resources to more closely regulate food safety. The bipartisan bill was sponsored by Senators Dick Durbin (D-Ill.), Judd Gregg (R-N.H.), Ted Kennedy (D-Mass.) and Richard Burr (R-N.C.). A parallel bill, the Safe Food Enforcement, Assessment, Standards and Targeting Act of 2009, was also introduced in the House. The new legislation proposes to increase the frequency of inspections at food facilities, give the FDA expanded access to company records and testing results, and allow the FDA to mandate recalls if a food company fails to follow the agency's recommendations. As reported and summarized by Janie Gabbett, from Meatingplace.com, the new bill will specifically:

• Require all food production facilities to implement preventive plans to address hazards and prevent adulteration, and give the FDA access to the plans and relevant documentation;

• Expand the FDA’s access to records in a food emergency;

• Allow the FDA to recognize laboratory accreditation bodies to ensure food testing labs meet high quality standards, and to require test results to be reported to the FDA;

• Allow the FDA to enable qualified third-parties to certify that foreign food facilities comply with U.S. food safety standards;

• Require importers to verify the safety of foreign suppliers and imported food;

• Allow the FDA to require certification for high-risk foods, and to deny entry to any food that lacks certification;

• Increase FDA inspections at all food facilities, including annual inspections of high-risk facilities, and inspections of other facilities at least once every four years;

• Enhance food-borne illness surveillance systems to improve the collection, analysis, reporting, and usefulness of data on food-borne illnesses;

• Require the Secretary of HHS to establish a pilot project to test and evaluate new methods for rapidly and effectively tracking/tracing fruits and vegetables in the event of a food-borne illness outbreak;

• Give the FDA the authority to order a mandatory recall of a food product when a company fails to voluntarily recall the product upon the FDA's request;

• Empower the FDA to suspend a food facility's registration if there is a reasonable probability that food from the facility could cause serious adverse health consequences or death;

• Direct the FDA to help food companies protect their products from intentional contamination, and rapidly respond to food emergencies;

• Increase funding for the FDA's food safety activities through increased appropriations and fees for domestic and foreign facilities.

In addition to receiving bipartisan support, many food companies and industry organizations have voiced support for the bill as well. Vocal supporters include General Mills, Kraft Foods and Kellogg's, along with the Grocery Manufacturers Association, the National Restaurant Association and the Produce Marketing Association. As reported by FoodNavigator-USA.com, Kirstie Foster, spokesperson for General Mills, stated:

“We are strong advocates for food safety system modernization and reform. Ensuring food safety is the highest priority of our industry. We support reform that includes both greater authority and greater resources to strengthen our ability to prevent and respond to food safety issues.”

In turn, Kraft spokesperson Susan Davison agreed, indicating that “the proposed legislation will make significant improvements . . .” Such comments were also echoed by the GMA, in a statement issued by president and CEO Pamela Bailey:

“Ensuring the safety of our products is the food industry’s most important priority... In particular, GMA supports proposals requiring all food companies to have a comprehensive food safety plan in place. It is absolutely critical that manufacturers take a preventative approach in identifying and evaluating potential hazards, and building food safety into the manufacturing process from the very beginning.”

Finally, according to Supermarketnews.com, Tom O’Brien, a representative for the PMA, also expressed support:

“I think the bills, if they get enacted, will restore consumer confidence in FDA, which in turn restores confidence in the food supply. They modernize FDA’s authorities, and they tell it that they should regulate based on the risk of any particular commodity. Those are very important things that we look for in legislation.”

Although the proposed legislation, if passed, would likely strengthen what already is a robust food safety system, there is unfortunately no solution that can completely eradicate food-borne illness. Like the common cold, flu and other ailments, illness occurs because microscopic pathogens exist in our world and can very easily contaminate our environment, our bodies and our food. Even if present in only small amounts that avoid detection, these organisms can eventually grow and multiply to levels that cause illness (whether introduced at a production facility or anywhere in the distribution chain). Moreover, despite continued best efforts to test for and find these pathogens, nature will continue to do its best to avoid being caught. Thus, although the proposed legislation will not eradicate illness, we are hopeful the new initiatives will, at the very least, help us more proactively identify and solve potential problems before they occur. 

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As fallout continues from the peanut butter recalls originally announced in early January 2009 by the Peanut Corporation of America ("PCA"), some have wondered why the original Salmonella outbreak investigation took so long, and why recalls are still continuing. Unfortunately, most food-borne outbreaks take weeks (and, sometimes months) to identify because of the complexity of the issues involved. Incubation periods (the delay between food consumption and symptom onset) can range from hours to many weeks depending upon the pathogen at issue (Learn about common pathogen incubation periods). Once a pathogen has been isolated from a patient, additional time is needed to perform genetic testing on the samples to determine whether other cases are potentially linked. In turn, if numerous cases are identified and a food-borne illness investigation is initiated, additional days or weeks can be added as state and local health officials attempt to identify a single food (or other) source that is common to all the cases (Learn how food-borne illnesses and outbreaks are investigated and tracked).

This process, of course, becomes exceeding difficult in outbreaks involving common foods – or, as demonstrated in the Salmonella peanut butter outbreak, foods that used the same raw materials but do not appear on their face to have any link (i.e., ice cream, candies, granola bars and even dog biscuits). Thus, although the ongoing salmonella outbreak took significant time to identify, hats off to the CDC and FDA for being able to conclusively establish a common source. Click on the following link to download a PDF of the FDA’s Salmonella outbreak investigation timeline:

After illnesses are reported and confirmed, a common source is found, and recalls are initiated, investigators and industry must then work to remove all potentially implicated product from distribution. Here too, this process becomes extremely difficult when a recalled product is used as a raw material in countless common foods. In this outbreak, the process was confounded further because what began as a recall from a single facility (and involving product produced during a relatively limited period of time) quickly morphed into a recall involving years of production from multiple plants. Following the expended recall at PCA’s Blakely, Georgia production facility (involving all products produced at the plant since January 1, 2007) and the subsequent recall from PCA’s Plainview, Texas facility (involving all products produced at the facility since it opened in March 2005), FDA and industry alike quickly found themselves overwhelmed with the task of determining what downstream food products might potentially be implicated. Click on the link below to download a PDF of the FDA’s “simplified” PCA peanut product distribution flowchart:

As demonstrated by the FDA timeline and distribution chart, investigating the outbreak, and coordinating what will likely be remembered as one of the largest recalls in history, proved extremely complex. To date, more than 2,700 consumer products have been affected, and the recalls are continuing (search for affected food products using the FDA Recall Interface located on the left-hand column of our blog).  Thus, despite the overwhelming frustration experienced by FDA, industry and consumers as a result of the ongoing outbreak, investigation and recalls, we once again express our gratitude to all of those working tirelessly to bring this matter to its closure.

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As recalls continue following the discovery in early January 2009 of Salmonella Typhimurium in peanut butter produced by the Peanut Corporation of America (“PCA”) in Blakely, Georgia, the Texas Department of State Health Services (“TDSHS”) has now confirmed that Salmonella was also isolated from peanut meal produced at PCA’s Plainview, Texas facility. Doug McBride, a spokesman for the TDSHS, also confirmed that the sample was the same strain as the ongoing nationwide outbreak.

PCA voluntarily closed its Plainview facility weeks ago, after a private lab sample showed likely Salmonella contamination. Soon thereafter, Texas health officials ordered a recall of all products ever produced at the facility since its opening in March, 2005.

As we reported earlier, the Colorado Department of Public Health and Environment had previously linked as many as six illnesses (that were associated with the national outbreak) to products distributed from PCA's Plainview facility. Additionally, an open container of Vitamin Cottage fresh ground peanut butter, made from raw materials produced at the Texas plant, had previously tested positive for the outbreak strain as well.

PCA also recently announced, in its latest Press Release, that because of continuing bankruptcy proceedings, it is no longer able to communicate with customers of recalled products. As a result, PCA customers should contact FDA Recall Coordinators regarding the proper disposition of any recalled products.

To date, over 2,600 consumer products have been affected by the continuing recalls. The national outbreak is believed to have sickened over 650 people in 45 states, and is suspected of contributing to as many as nine deaths. For the latest information, visit the FDA Peanut Butter Recall Website.  We, of course, will continue to report additional developments as well.

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As the CDC outbreak investigation continues, and thousands of products are recalled, reported cases are on the decline. 

In early January 2009, the CDC and public health officials determined that peanut butter products were the likely source of the ongoing national Salmonella Typhimurium outbreak. Product testing eventually prompted recalls of various peanut butter products produced by the Peanut Corporation of America (“PCA”). Crisis management efforts, at all levels, then began in earnest.  On January 28, 2009, PCA recalled all peanuts, peanut meal, peanut paste and peanut butter, distributed from its Blakely, Georgia facility since January 1, 2007. Following additional governmental investigations, PCA also recalled all products, including peanut meal, granulated peanuts and dry roasted peanuts, produced and distributed from its Plainview, Texas facility since the plant opened in March 2005.

PRODUCTS AFFECTED:

Although the majority of products produced by PCA were not distributed for direct consumer sale, most products were distributed to downstream manufacturers for use as ingredients in many other products. As a result, the PCA recalls prompted hundreds of these manufacturers to recall their own products as well. Given the expansive scope of the recalls, and diverse use of PCA’s products as raw materials in many consumer foods, the FDA and industry are continuing their efforts - even to this day - to determine what additional products might potentially be affected. So far, more than 2,000 consumer products have been recalled. To find products affected, use the searchable FDA Recall Interface on our blog (just scroll down the left-hand column).

PRODUCTS NOT AFFECTED:

According to the CDC, major national brands of jarred peanut butter found in grocery stores are NOT affected by the recall. As we reported previously, Girl Scout Cookies are also Not affected. For a list of additional products not affected by the ongoing recalls, please visit the American Peanut Council Website.

CDC INVESTIGATIVE UPDATES:

The following are highlights from the CDC’s most recent investigation update:

• Case count is 642 in 44 states with latest confirmed, most recent reported illness beginning on January 28, 2009;

• Although the outbreak is continuing, the numbers of new cases have declined modestly since December. Many recently ill persons report eating peanut butter and other recalled peanut-containing products; and

• Consumers should continue to check at home for recalled peanut butter containing products, and discard them.

As noted, as of February 15, 2009, 642 persons believed to be infected with the outbreak strain have been reported from 44 states. The number of ill persons identified in each state is as follows: Alabama (2), Arizona (13), Arkansas (6), California (76), Colorado (15), Connecticut (10), Florida (1), Georgia (6), Hawaii (4), Idaho (16), Illinois (9), Indiana (9), Iowa (3), Kansas (2), Kentucky (3), Maine (5), Maryland (8), Massachusetts (48), Michigan (35), Minnesota (39), Missouri (14), Mississippi (7), Nebraska (1), New Hampshire (13), New Jersey (23), New York (28), Nevada (6), North Carolina (6), North Dakota (17), Ohio (94), Oklahoma (4), Oregon (12), Pennsylvania (19), Rhode Island (4), South Dakota (4), Tennessee (13), Texas (9), Utah (6), Vermont (4), Virginia (21), Washington (18), West Virginia (2), Wisconsin (5), and Wyoming (2). Additionally, one ill person was reported from Canada (learn how food-borne illness outbreaks are tracked).

Oregon public health officials also recently confirmed, in a press release, that the ongoing outbreak may have also affected some pets. One laboratory-confirmed case of Salmonella in a dog from an Oregon household was reported, and further characterization of this Salmonella isolate is pending. Salmonella resembling the outbreak strain was also reportedly isolated by a private laboratory from recalled Happy Tails dog biscuits from the dog’s household. 

We, of course, will continue to report new developments.

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Agriculture Secretary Tom Vilsack recently announced that, despite previous opposition, he now favors combining the food safety functions of the United States Department of Agriculture (“USDA”) and Food and Drug Administration (“FDA”) into a single food safety agency. Currently, the USDA through it’s Food Safety and Inspection Service (“FSIS”) is responsible for regulating the safety of meat, poultry and egg products. In turn, the FDA has responsibility for most other foods. In his recent comments, Vilsack also stated that he has not yet decided whether a single agency would be best located within the FSIS, the FDA or an independent agency.

As debate continues about merging the food safety responsibilities of the USDA and FDA, Janie Gabbett (from Meatingplace.com) reported that the majority of industry participants in an online survey favored combining the food safety regulatory functions of the USDA and FDA, but only one in five believed that such a merger would result in improved food safety.

Of 289 readers who responded to the survey, 58 percent agreed the two agency functions should be combined, while 42 opposed a merger. When respondents were asked if they thought that a merger of the two agencies would improve food safety, 50 percent believed that food safety would remain unchanged, while 30 percent believed that the quality of food regulation could actually decline.

According to the survey, participants were more concerned with deficiencies in FDA regulation than in FSIS protocols. Namely, this is because, unlike the FDA, FSIS inspectors currently maintain a continuous, on-site presence in meat packing facilities, and also regularly test meat and poultry products for harmful pathogens. As a result, several respondents also concluded that if the agencies were to merge, the FDA would need to become more like FSIS, and not the other way around.

Other suggestions from survey participants included:

• Providing better technology and tools for inspectors;

• Increased laboratory testing;

• Imposing fines on plants with repeated serious violations;

• Requiring all food establishments to adopt and implement Hazard Analysis and Critical Control Point (“HACCP”) plans;

• Requiring all food establishments to adopt and implement sanitation standard operating procedures (“SSOPs”);

• Continuing to improve risk-based analysis of food safety systems in plants;

• Targeting high-risk foods (under FDA jurisdiction) and moving toward to the USDA model of inspection;

• Providing better training for inspectors; and

• Funding additional research to improve food safety.

According to Gabbett, many respondents also believed that, even with a single food safety agency, increasing the funding and number of federal inspectors would likely be needed to improve the effectiveness of regulations. According to one respondent, "simply merging two departments and changing their names . . . won't affect food safety." Rather, "there would need to be fundamental changes at the plant inspection level to actually make a difference."

Currently, the United States is the only industrial nation to have two separate federal food safety regulatory systems. Moving forward, we'll continue to post on emerging developments.

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As many as six cases associated with the ongoing Salmonella outbreak may have been traced to products produced at PCA's Plainview, Texas production facility. According to the Colorado Department of Public Health and Environment, these individuals reported exposure to peanut butter distributed by the Lakewood-based Vitamin Cottage. In turn, an open container of Vitamin Cottage fresh ground peanut butter, made from peanuts distributed from the Texas facility, tested positive for the outbreak strain of Salmonella. Because the container was opened, however, it is not yet known if the peanut butter was potentially contaminated at the Texas facility, or if the product was cross-contaminated with the outbreak strain after distribution (learn how food-borne illnesses and outbreaks are tracked). Vitamin Cottage, in a Recall Notice, announced last week that it was recalling these products.

It is estimated that, since opening in March 2005, PCA's Plainview, Texas facility produced and distributed about one-third of the volume of products that were distributed from the company's Blakely, Georgia plant.  Although Salmonella has not yet been isolated from any non-opened products distributed from the Plainview facility, it has been reported that truck loads of raw peanuts from PCA's Georgia facility were previously sent to the Texas plant.  Currently, the FDA is still waiting on lab confirmation from numerous product and environmental samples taken from the facility determine the extent, if any, of potential contamination. 

In addition to operating plants in Georgia and Texas, PCA also operated a facility in Virginia. The FDA has completed a comprehensive inspection of the Virginia plant, and has reported that all lab results were negative for Salmonella. Although PCA closed this facility following its bankruptcy announcement on February 13, 2009, the FDA has not taken any action against the Virginia plant or any of the products produced there.

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On Monday, February 9, 2009, the Plainview Peanut Co., a subsidiary of Peanut Corporation of America (“PCA”), voluntarily halted operations at its Plainview, Texas production facility pending the resolution of continuing governmental investigations.

On Thursday, February 12, 2009, the Texas Department of State Health Services announced, in a News Release, that it has ordered a recall of all products ever produced at the facility. The order followed the discovery of various sanitary issues identified in the plant.  The following day, on Friday, February 13, 2009, PCA formally declared bankruptcy.

The newest recall follows PCA's announcement, on January 28, 2009, that it was recalling all peanuts, peanut meal, peanut paste and peanut butter, distributed from it's Blakely, Georgia facility since January 2007.  PCA has now recalled all products, including peanut meal, granulated peanuts and dry roasted peanuts, produced and distributed from the Plainview, Texas facility since March 2005.   

Earlier, investigators reported that the Plainview facility had been operating for years without any inspections or licensure from the state. As the FBI continues its criminal probe into PCA's operations, we will continue to report new developments.  

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In the coming months, the FDA will likely begin requiring food manufacturers that obtain positive test results from product samples to report such findings to the agency. Although the new rules will likely have a significant impact on industry as adjustments are made to ensure compliance, the rules (once implemented) would likely add an additional layer of safety to our food regulatory system.

In 2007, former President Bush signed into law the Food and Drug Administration Amendments Act (Public Law 110-85). The Act, which amended the Federal Food, Drug and Cosmetic Act by creating a new section 417 (21 U.S.C. 350f), required the Secretary of Health and Human Services, no later than September 27, 2008, to establish a Reportable Food Registry. The stated purpose of the amendment was “to provide a reliable mechanism to track patterns of adulteration in food [which] would support efforts by the FDA to [better] target [its] limited inspection resources.” Implementation of the new law, along with its mandatory reporting requirements, however, has been delayed while the FDA continues to develop an effective electronic reporting system.

In its current form, the new food registry will apply to food manufacturers, and will define “reportable foods” as any article of food (other than infant formula) found to contain harmful pathogens, “for which there is a reasonable probability that the use of, or exposure to, such of food will cause serious adverse health consequences or death to humans or animals.” 21.U.S.C. 350f. If a food sample tests positive for any pathogen considered an adulterant for the particular food at issue, manufacturers would be required, within 24 hours, to submit an electronic report to the agency.

Currently, the FDA anticipates that the registry (and the associated reporting requirements) will likely go into effect sometime later this spring.  We, of course, will keep you posted.

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The salmonella peanut butter recall, which is still expanding, will likely be remembered as one of the largest in history.  On January 28, 2009, the Peanut Corporation of America ("PCA") announced a recall of all peanuts (dry and oil roasted), peanut meal, peanut paste and peanut butter that had been produced at its Blakely, Georgia facility since January 1, 2007.  Although none of the products involved in the expanded recall were distributed for direct consumer sale, the products were supplied to downstream manufacturers for use as ingredients in many other foods. To date, more than 1,500 consumer products have been recalled, and hundreds of companies (including manufacturers, distributors, grocers and retailers) have been directly impacted.  Find products affected by the ongoing recall using the searcheable FDA Recall Interface. (just scroll down the left-hand column of our blog). We will continue to keep the interface, which is updated coninuously, running until the outbreak has concluded and recalls have been closed. 

As you may recall, the salmonella outbreak was first identified by the CDC in late 2008.  On January 13, 2009, following the discovery of salmonella in its products, PCA announced the initial recall of peanut butter and peanut paste. On January 28, 2009, following an extensive governmental investigation into the manufacturing procedures utilized by the company, PCA expanded the recall to include all peanuts (dry and oil roasted), peanut meal, peanut paste and peanut butter produced at the facility since January 1, 2007. 

Given the expansive scope of the recall, and diverse use of PCA’s products as raw materials in many consumer foods, the FDA is continuing to work closely with industry to determine what additional products might potentially be affected. As continuing recalls are announced, the searchable interface will be updated automatically. 

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According to reports, Congress will likely hold public hearings on the ongoing salmonella outbreak and recalls.  Representative Henry Waxman (D-California) stated recently that the hearings, anticipated within the coming weeks, will likely focus on the Blakely, Georgia facility owned and operated by the Peanut Corporation of America (“PCA”).

As the FDA continues its investigation into the ongoing outbreak, early reports have suggested that salmonella was isolated, on various dates in 2007 and 2008 from certain PCA products, by private labs PCA employed for routine testing. These reports have also indicated, however, that subsequent testing resulted in negative findings.  Because the specific protocols followed by PCA and the labs in question (along with the specific circumstances surrounding the sampling and testing of such products) are not yet fully understood, all parties will need to wait for the investigation to be completed before any final conclusions can be made regarding the ultimate merits or implications of these reports.  Additional information may also be learned from the proposed hearings, during which it is anticipated that representatives of PCA and the laboratories in question may be called to testify.

On Wednesday, January 28, 2009, PCA expanded its initial recalls (announced on January 13, 2009 and January 18, 2009 respectively) to include additional products produced at the facility since January 1, 2007 (see our reports below).  For continuing updates regarding the growing list of products affected by the expanded recall, please visit the FDA Peanut Butter Recall Website.  The American Peanut Council has also published a list of products reportedly not affected by the ongoing recalls.

To date, more than 500 people may have become sick, and as many as eight people may have died, in connection with the ongoing outbreak.  Although most of these illnesses are presumed to be associated with peanut butter, not all cases may be directly linked.  Early reports have indicated that at least one person from Wyoming (who was carrying the outbreak strain) did not appear to have any known exposure to peanut butter products.

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The Peanut Corporation of America (PCA), in a press release, has announced an expanded recall of peanut butter products produced at its Blakely, Georgia facility. The expanded recall covers products produced at the facility since January 1, 2007 (the previous recalls only involved peanut butter and peanut paste products distributed from the facility since July 1, 2008).  In addition to peanut butter and peanut paste, the expanded recall includes all peanuts (dry roasted and oil roasted), granulated peanuts, peanut meal and similar products.

PCA reports that, although none of the products involved in the expanded recall were distributed for direct consumer sale, the products were distributed to downstream manufacturers for use as ingredients in many other products.  Amended lists of products potentially affected by the expanded recall have not yet been released, and will likely be announced in the coming days. 

For more information on recent developments associated with the ongoing recalls, please visit our Food Recall Tracker, or the FDA Peanut Butter Recall Website.

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As we continue to comment on food safety litigation avoidance and crisis management, several food industry groups on Friday, in letters to Congress, urged House and Senate leaders to quickly enact enhanced food safety reforms.  The letters announced that, although “Americans continue to enjoy the safest food supplies in the world, . . . new challenges require Congress and the Administration to modernize our food safety net.”  In turn, industry groups urged lawmakers to move forward on the following FDA proposals, originally announced in 2007, as part of the FDA’s Food Protection Plan:

• Require Domestic Food Safety Plans:  As proposed, the initiatives would require domestic food producers to affirmatively identify potential food safety risks associated with production methods and products, identify and implement enhanced production or other controls, and prepare formalized food safety plans (for FDA review) addressing such risks;

• Require Foreign Food Safety Plans:  Adoption of the pending initiatives would also empower the FDA to assist foreign governments seeking to adopt robust food safety regulations, and require foreign food product importers to better police foreign suppliers. The initiatives would also, in part, require domestic foreign food product importers to document food safety controls being implemented by foreign suppliers, and require such records to be available for FDA review; and

• Adopt A More Robust Risk-based Approach to Inspections:  As proposed, the initiatives would also enable the FDA to increase food safety inspections for those facilities and products (both foreign and domestic) that pose, based upon science and risk-based studies, the greatest risk of potential contamination.

In addition to encouraging a more robust food safety inspection system for domestic and foreign products, the letters also urged Congress to better enhance the safety of fruits and vegetables by establishing uniform standards for high-risk products.  In addition, the letters addressed the FDA’s continuing request for mandatory recall authority, which would be available to the agency in those rare circumstances where companies refused, following FDA recommendations, to initiate recalls voluntarily.

The letters were undersigned by numerous industry organizations, including the Grocery Manufacturers Association, the Food Marketing Institute, the American Frozen Food Institute, the International Bottled Water Association, the International Dairy Foods Association, the National Fisheries Institute, the National Restaurant Association, the Retail Industry Leaders Association, the Snack Food Association and the United Fresh Produce Association.  According to Pamela Bailey, President and CEO of the Grocery Manufacturers Association, improved food safety tools would ultimately enable us to better “maintain our position of global leadership and assure consumer confidence.”

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For nearly a decade, our food safety team has worked closely with food companies managing outbreaks and defending claims.  In most cases, outbreaks and recalls can be effectively managed by working closely with governmental agencies to gain a complete picture of an ongoing investigation, while at the same time encouraging investigators to freely and rapidly share developing information 

Unfortunately, however, accurate information regarding the potential sources or scope of an outbreak can sometimes be extremely difficult for companies to obtain.  This is because, once illnesses are identified, the CDC and FDA (along with state and local health departments) are the only entities who have real time access (via PulseNet and OutbreakNet) to the most current and important information regarding the developing outbreak. 

As a result, until developing outbreak information is actually shared by investigative agencies, food companies in the supply chain often have no idea what specific upstream companies, suppliers, product lines and/or lots might potentially be implicated in the ongoing investigation.  This is especially true when multiple companies are involved in the production of a product, and where lots are, in some instances, defined by hours or days.   In turn, most companies must wait for information to be shared by governmental investigators before even becoming aware that their products might potentially be involved - let alone to be in a position to determine whether to issue a precautionary recall of select foods.  This is also why, in our view, it is extremely important for consumers and industry alike to understand fully how food-borne illnesses and outbreaks are identified and tracked.

In the current salmonella outbreak investigation, these efforts, of course, are continuing.  Since our last update, an additional six companies have announced precautionary and voluntary recalls of select products manufactured with raw materials potentially associated with the current outbreak.  These companies include Landies Candies (select peanut butter filled chocolates), Lovin Oven (certain Peanut Crunch Chewy Granola Bars), Best Brands Corp. (peanut butter frozen cookie dough), Aspen Hills (certain cookie dough products), Nash Finch (select bakery products), and Chef Jay's Food Products (select peanut butter bars, cookies and brownies).  In turn, following the expanded recall by the South Bend Chocolate Company (which included various candies containing peanut butter), the Rain Creek Baking Corporation announced a voluntary and precautionary product withdrawal of select Peanut Butter Turtles, Baskets and Princesses. 

Although the CDC reports that it is still working to determine whether any additional food products might be affected, it confirms (as we reported previously) that these and other product manufacturers are working very closely with the agency to identify the existence and scope of any additional potentially affected foods.  We appreciate their joint and continuing efforts.  We also, of course, will continue to report as additional news develops.

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While the USDA and FSIS work hard to protect our meat and poultry supply, the FDA works to ensure that the remaining 78 percent of domestic and imported food remains safe.

Although the FSIS maintains a continuous presence in most meat and poultry plants, the FDA typically only visits food processing facilities once a year. Following a number of highly publicized recalls, however, some began suggesting that the FDA should follow the USDA model, requiring more regulation and a more visible federal presence within FDA-regulated food processing facilities. Thus, the question was called: Would the FDA become more like the USDA?

Maybe just a little. In November 2007, the FDA unveiled a new initiative, called the "Food Protection Plan." The plan avowed three “core elements” - prevention, intervention and response - to better ensure a safer quality of food for all Americans (FDA, “Food Protection Plan: One-Year Progress Summary”). While, as part of these efforts the FDA asked Congress for additional regulatory authority, including new mandatory recall powers, most agree it would be far too impractical, expensive and imprudent to demand or even require a significant increase in domestic inspection. In June, for instance, the Government Accountability Office actually condemned the plan for “failing to provide details on the costs or specific strategies.”

In any event, within the coming months, we will see where these efforts lead. Personally, I expect the FDA’s regulatory control to grow significantly in the coming years (resulting, for instance, in the implementation of a mandated HACCP-based system for many new categories of foods). Thus, although it remains unlikely in the near term that federal inspectors will be physically “moving in” to your food production facility (as occurs in slaughter establishments), you may nevertheless find them knocking on your door more often, at the very least, to critique your HACCP plan.

Stay tuned for new developments.

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• Return to Defending Claims.

Defending a food-borne illness claim requires a thorough understanding of how our food is regulated.  Because many governmental agencies (both state federal) play a role in the regulation of virtually all of the foods we eat, it is critical in every case to understand: (1) the role of each regulatory agency in the production of the food at issue; and (2) the specific laws, regulations and rules that apply to the particular product.  Although the history of federal oversight over our food supply is quite long and storied, the following discussion summarizes generally the progression and current status of the federal regulation governing the food we eat.

At the dawn of the last Century, our nation, through advances in science and technology, began to gradually understand the processes through which we could make food more accessible. Due to the emergence of rapid transnational shipping, improved preservation techniques and the ability of media to reach an increasing number of consumers, the food industry revolutionized. For the first time, food processors could viably ship perishable products anywhere in the nation.

As interstate shipment of food began to increase, however, food safety regulations were inadequate. In the absence of a federal approach (there had not yet been a need) America’s food laws were implemented primarily at the state and local level. As can be expected within a growing nation, industrial advances were quickly outpacing limited state and local regulations. In the meat industry, in particular, laws defining what constituted “adulteration” or “misbranding” were determined, if at all, by each individual state. Moreover, what was forbidden in one state was entirely lawful in another. This hodgepodge of inconsistent regulation soon inspired concerned citizens, consumer groups and social reformers to voice their concerns. Without a national approach to food safety (and a single set of rules), American citizens in the various States had no confidence in the origins or safety of the food they were eating.

During this period, technological advances outside of the food industry were also instrumental to inspiring incredible change. The emergence of inexpensive newspapers that reached across the nation gave individuals and consumer groups greater opportunity to voice their concerns. Social reformers, who otherwise would have remained unheard, could now reach a broad audience. The most famous example, of course, was Upton Sinclair. In his 1906 novel, The Jungle, Sinclair described the unsanitary conditions prevalent in large slaughter plants. The book described unwholesome carcasses being processed for use in food, processing taking place in unhealthy conditions, and meat and other food products coming into contact with contaminants present in the plants. Such conditions outraged the public, and the growing demand for change soon became too loud for Congress to ignore. Inspired by this national chorus, the federal government realized that a uniform food safety policy (i.e., a single set of rules) was essential to protect both the national economy and the health of American citizens.

The federal approach to food safety was, for all practical purposes, solidified in 1906, when the United States Congress passed the Wholesome Meat Act and the Pure Food and Drugs Act. These Acts (along with their successors) formed the framework for the national food safety policy that continues to exist to this day.

The 1906 Wholesome Meat Act (now known as the Federal Meat Inspection Act, 21 U.S.C. § 601, et seq.) was originally enacted in response to The Jungle. With the sweep of a pen, the federal legislation required continuous federal inspection within meat packing plants to ensure that all meat products sold in interstate commerce would be: (1) produced under sanitary conditions; (2) not adulterated; and (3) properly labeled. Today, the Federal Meat Inspection Act (“FMIA”) is enforced by the Food Safety Inspection Service (“FSIS”), an agency falling within the jurisdiction of the United States Department of Agriculture (“USDA”). In meat packing plants, the FMIA continues to require continuous, on-site inspection of the entire slaughter and processing process. In addition to its inspection responsibilities, the USDA also closely regulates product labeling. Over the decades, USDA’s authority has expanded to oversee poultry production under the Poultry Products Inspection Act (21 U.S.C. § 451, et seq.) and egg production under the Egg Products Inspection Act (21 U.S.C. § 1031, et seq).

Like the FMIA, the original Pure Food and Drug Act was also enacted in response to social pressure. While the Wholesome Meat Act was designed to oversee the production of meat, the Pure Food and Drug Act was created to increase confidence in many other foods. Here too, Congress was inspired to action following a number of well-publicized scandals involving the food industry, including one where American soldiers serving in the Spanish-American war were allegedly sickened by embalmed foods. Additionally, with advances in chemistry, it was becoming more common for business to use various additives to preserve foods. These activities, of course, also triggered additional debates involving the merits of substitute foods, such as margarine for butter, and the use of questionable “ingredients” such as coal tar, borax, and various food colors. In response, the 1906 Pure Food and Drugs Act, as originally enacted, forbade adulteration and misbranding of foods in interstate commerce. This Act was amended several times before being replaced in 1938 by the more stringent Federal Food, Drug and Cosmetic Act (“FDCA”). 21 U.S.C. § 301 et seq. Today, the FDCA is enforced by the Federal Food and Drug Administration (“FDA”), an agency falling under the jurisdiction of the Department of Health and Human Services (“DHHS”). Currently, the FDA has jurisdiction over approximately 78 percent of the domestic and imported foods sold in interstate commerce, and seeks to ensure that such products are safe, nutritious, wholesome, and adequately labeled. Although the FDA, unlike FSIS, does not provide continuous inspection in food processing facilities, it has jurisdiction (and conducts periodic inspections) where food is processed, packaged, stored and sold.

Although the USDA and the FDA share most of the regulatory responsibility for food safety in America, the following additional federal agencies are also responsible for food safety as part of their federal mandate:

• The Centers for Disease Control and Prevention (“CDC”), within the DHHS, gathers data on food-borne illnesses, investigates food-borne illness outbreaks, and monitors the effectiveness of numerous prevention and control initiatives. As part of these efforts, CDC also helps state and local epidemiologists (and state health laboratories) identify and prevent food-borne illness and other outbreaks. The CDC engages in these activities under the general authority of the Public Health Service Act. 42 U.S.C. § 201, et seq.

• The Environmental Protection Agency (“EPA”) protects the nation’s water supply by setting standards for drinking water under the Safe Drinking Water Act. 42 U.S.C. § 300g, et seq. The EPA also regulates pesticide products and establishes tolerances for residues on various food commodities and animal feed. The EPA operates under the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”), 7 U.S.C. § 136, et seq., and the FDCA.

• The Animal and Plant Health Inspection Service (“APHIS”) is another agency which falls within the USDA umbrella. The APHIS is responsible for administering various federal laws and regulations to enhance the health and care of animals and plants. The APHIS assists with food safety on a national level by coordinating needed research and other efforts to protect the industry against pathogens or diseases that are a risk to humans.

• The Grain Inspection, Packers and Stockyards Administration (“GIPSA”) is another agency, within the USDA, which helps establish quality standards for food products. The GIPSA also coordinates a national inspection system for grain and related products (and reports its findings to the FDA) to ensure compliance with the FDCA, the United States Grain Standards Act, 7 U.S.C. § 71, et seq., and the Agricultural Marketing Act (“AMA”) 12 U.S.C. § 1141, et seq.

• The Agricultural Marketing Service (“AMS”), another agency within the USDA, is responsible for establishing quality and grading standards for various dairy, egg, fruit, meat, poultry, seafood and vegetable products. As part of the grading process, the AMS considers various safety factors, such as the cleanliness of the product. The AMS operates programs under a number of federal laws relating to food safety, including the AMA and the EPIA.

• National Marine Fisheries Service (“NMFS”), an agency within the United States Department of Commerce, administers voluntary seafood quality inspection programs. In addition to the inspection and certification of fish products for human consumption, the NMFS also provides inspection of animal feeds and pet foods derived from fish products. The NMFS operates under the AMA and the Federal Fish and Wildlife Act. 16 U.S.C. §742, et seq.

• The Federal Trade Commission (“FTC”) enforces the Federal Trade Commission Act, 15 U.S.C. § 41, et seq., which prohibits unfair or deceptive practices. The FTC’s food safety objective is to prevent the dissemination of false advertising which has the purpose of inducing the purchase of food.

Improving food safety is and always will be a scientific endeavor. As such, it will be important for our government to remain flexible as new technologies emerge and discoveries are made. The federal government understands this, and is constantly working to improve and enhance existing capabilities. The federal government expends vast resources in the fields of applied research and risk assessment as it relates to food safety. Research is conducted in a wide variety of disciplines, by a number of different entities. These include efforts by, among others, the National Institutes of Health, the National Institute for Food Safety Technology (MOFFET Center), the National Advisory Committee on Microbiological Criteria for Foods (“NACMCF”) and the USDA’s Agricultural Research Services.

In addition to extensive research, the federal approach to food safety has in recent years also focused on consumer and industry education. The federal government has developed food safety educational programs that span the entire farm-to-table continuum. This includes educating farmers, producers, distributors, food-handlers and consumers. An excellent example is the “FightBAC!” campaign, sponsored by the Partnership for Food Safety Education, which was created to help educate consumers about the potential food-borne illness hazards associated with improperly handling and cooking raw meat and poultry products.

Together, these agencies (and initiatives) promote food safety and attempt to reduce food-borne illness through inspections, surveillance, enforcement, research, risk assessment, pre-market approval, controls for safe processing, and education. The federal approach to food safety has evolved into a vast, multi-pronged food safety system managed by thousands of caring and dedicated Americans.

Copyright 2009 by Shawn K. Stevens

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