Enhancing Traceability And Outbreak Response

This past December, FSIS and FDA jointly hosted a two-day public conference regarding Improving Product Tracing of Foods: More Rapid Outbreak Response.

While opening the conference, Jerold Mande, Deputy Undersecretary for Food Safety, called product traceability one of the most pressing challenges in food safety today. And, although the goal in any outbreak investigation to quickly identify and stop emerging outbreaks, Mande recognized that “finding solutions to increase the speed and accuracy of product tracing” will be very “difficult.”

FSIS held a second public meeting on product tracing in March (FSIS Product Tracing Related to E. coli O157:H7), specifically focused on two issues: (1) Agency procedures for identifying suppliers of source material used to produced raw beef product that FSIS has found positive for E. coli O157:H7; and (2) additional verification activities the Agency will conduct at suppliers’ facilities in response to positive E. coli O157:H7 results.

Obviously, the traceability issue is heating up, and everyone from farmers to packers to processors to retailers should keep abreast. Meat and Poultry B2B Data Standards Organization (mpXML) and GS1 US recently released a new guide for implementing product traceback minimum requirements and best practices. These materials are intended to supply all members of the U.S. meat and poultry industry, regardless of size, with enhanced guidance for tracing:

  • Trading partners (your suppliers, your own company, your customers, 3rd party carriers);
  • Trading locations (any physical location such as a warehouse, packing line, storage facility, receiving dock or store);
  • The products your company uses or creates;
  • The logistics units your company receives or ships; and
  • Inbound and outbound shipments.

The guide was developed with meat and poultry suppliers, retailers and trade associations, and the USDA’s Agricultural Marketing Service.

Many industry stakeholders, including Costco, Perdue, Safeway, Tyson, Walmart, the American Meat Institute, and the National Chicken Council participated in the development. Doug Bailey, chief information officer of the USDA’s Agricultural Marketing Service, commented on the guide: “We view traceability as a component of an orderly marketing system, and this guide is a great example of industry collaboration to standardize the business processes that relate to traceability.”

As noted by Mande, traceability remains a “pressing” and “difficult” issue for all segments of the food industry. It is on the President’s agenda, the USDA’s agenda, and it impacts consumer confidence and health.  For this reason, you may find the new guidance materials helpful as you work to supplement or enhance your own internal practices.

FSIS Publicizes Newly Approved Food Safety Technologies

Many of the new technologies developed by meat and poultry processors must first be reviewed by the Food Safety and Inspection Service (“FSIS”) prior to implementation.

Processors are required to submit a written description to the FSIS of any new technology that could affect: (1) product safety; (2) inspection procedures; (3) inspection program personnel safety: or (4) would require changing existing regulations. FSIS, following its review of the processors’ submission, either notifies the processor that it has “no objection” to application of the new technology, or that it has concerns and will require additional information prior to any use of the new science. (See Guidance Procedures for Notification and Protocol Submission of New Technology).

FSIS has acknowledged that many “new technologies have resulted in significant improvements in the safety of meat and poultry in recent years.” The Agency also believes there will be even greater use and benefit from such technologies if they can also be shared with the public and industry. Therefore, FSIS makes available to the public a list of new technologies to which the Agency had no objections.

The FSIS New Technology Information Table contains a brief description of the technologies and names the companies which pioneered them. The list was just updated and contains all new technologies approved within the last 12 months.

If you have not yet added the New Technology Information Table to your “Favorites”, please do so. Meat and poultry processors are investing millions of dollars each year on the issue of food safety alone.

We, of course, can all gain by sharing and remaining abreast of food safety innovation.

FMI Releases Norovirus Guide For Industry

The Food Marketing Institute (FMI), in collaboration with Ecolab, has developed and released a new Norovirus Information Guide for industry.

As drafted, the Guide is intended to provide assistance to all types of food establishments in preparing for, and then reacting to, a potential Norovirus incident. Click on the following link to download a copy of the FMI Norovirus Guide.

Several FMI Food Protection Committee members actively participated in its development along with other professionals throughout the industry, academia and the regulatory arena.

With their collective input, direction and expert review, the FMI document reflects the most current Norovirus guidance for the food industry.

Food Safety On Big City Streets

Over the years, I have sampled numerous street food offerings in various cities throughout the U.S. More recently, I have been intrigued by news that certain street foods are both “going gourmet” and growing in popularity.

A few weeks ago, the Chicago Tribune reported on a new movement (spearheaded by gourmet chef Matt Maroni) to greatly expand Chicago’s street food scene (“Chef hopes to change Chicago laws barring gourmet food trucks”).

Unlike many other major cities, Chicago’s ordinances currently permit only pre-prepared and packaged foods to be sold on the street (i.e. hot dogs and popcorn). This is because there can be numerous potential hazards associated with the preparation of foods in mobile food trucks or stands. These include:

  • If a food truck or stand is not parked close enough to a bathroom with a hand washing station, the food preparers could themselves contaminate food;
  • If the food truck or stand runs low or runs out of potable water (which the truck itself must store in a tank), hands, utensils, equipment and food preparation areas may not be properly washed and sanitized;
  • There is the potential for the truck’s power source to inadequately maintain hot and cold temperatures (especially during the heat of summer); and
  • There is the potential for cross-contamination between foods such as raw meat and produce due to the limited storage and preparation space.

Recognizing the growing public interest in gourmet street food, however, chef Maroni is hoping to amend the regulations to allow preparation of fresh food made-to-order in a mobile food truck (i.e. flatbread stuffed with braised lamb, marinated tomatoes and a curry tzatziki).

In the amended ordinance he has proposed, Maroni does tackle the potential food safety concerns. And Elizabeth Gomez, director of outreach for Chicago alderman Scott Waguespack, a proponent of the ordinance, said “[w]e are taking our time to make sure that we are addressing public health and safety concerns [and] to ensure that we create an ordinance that will be successful in Chicago." Better technology, as well as commitment to food safety, can also reduce the risks in mobile food trucks. New state-of-the-art food trucks were showcased at the National Restaurant Association’s recent show in Chicago.

So, while we absolutely need to ensure that food (wherever prepared) is prepared safely, I will be watching the new ordinances with curiosity. And, chef Maroni’s braised lamb sure sounds good…

Meat And Poultry - Bringing The World Just A Little Bit Closer

Hamburgers and fries have long been a staple of both American diet and culture.

In recognition of that, President Barack Obama treated friend, and fellow world-leader, Dimitri Medvedev to lunch at Washington’s favorite burger restaurant.

Ray’s Hell-Burger, a Washington hot-spot, is known for delicious, ten-ounce behemoths which are built from hand-trimmed, freshly ground beef. The restaurant is located in an unassuming storefront and boasts numerous B-movie posters and wooden tables outfitted with an assortment of condiments and a roll of paper-towels.

What did the two leaders talk about while consuming the all beef patties? Ironically, it was poultry. The men agreed, over their 10-ounce burgers, to resume poultry exports to Russia, overturning a ban that was put in place earlier this year. The dispute arose over the use of a chlorine rinse which Russia said violated its food-safety rules. Fortunately, the Washington burgers helped seal the deal, and poultry is now back on the menu. 

And, once again, a simple meal proves its worth in bringing us all just a little bit closer.

Oysters And Oil: Coastal States Struggle With Seafood Safety

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.

Clarification Creates Confusion: Final Comments Received On FSIS' Preliminary Validation Guidance

In late 2008, the FSIS announced that it intended to issue a Federal Register Notice to better explain the validation requirements under its HACCP regulations.

The Agency deemed this clarification necessary because of the “widespread lack of understanding of validation that FSIS has found among establishments, whether large or small HACCP in size or high or low in production volume, and because of the food safety problems that have occurred as a result.”

Unfortunately, the FSIS’s attempt to clarify has created some confusion and much concern. In the past year and a half, the meat industry and its trade associations have given considerable feedback to the Agency regarding validation. Even before the FSIS even issued its preliminary “Draft Guidance for HACCP System Validation” in March 2010, nine trade associations banded together to submit their comments to FSIS on the issue. Since opening the period for public feedback, FSIS has received almost 2,000 comments.

The thrust of the confusion and concern lies with the FSIS’s expectations for microbiological testing under the guidelines. Currently, the guidelines state that “establishments would need to provide support in instances where they believe microbiological testing data is not needed to demonstrate the effectiveness of the HACCP system in controlling biological food safety hazards.” Although the Agency has explained that the guidelines will not impose new microbiological testing requirements on establishments, there is distrust on the issue, particularly by small processors.

Some confusion has already been dispelled through the comment process, however, which highlights the importance of all processors – large and small – being well versed in the draft guidelines and the changes which need to be incorporated. Following an initial review of comments, the FSIS released a Fact Sheet addressing some concerns. The FSIS Fact Sheet confirmed that, among other things, no microbiological testing would be required for "well-established processes", and that establishments would only need to validate one plan per HACCP category.

The final day to submit comments on the preliminary draft guidance is Saturday, June 19, 2010. The Agency plans to complete a final review of the comments on the preliminary draft guidance and then issue an updated draft document in July 2010 for a second round of comments. The FSIS will also hold two public meetings regarding the updated draft.

Hopefully, the FSIS’s willingness to go through a lengthy drafting and comment process will result in true clarification and, ultimately, fewer of the food safety confusion which spurred the Agency to reevaluate its position on validation.

New Study Confirms That UV Light Is Effective In Reducing Listeria On Broad Range Of Food Product Conveyor Belts

Food manufacturers may soon have additional incentive to add yet another weapon – ultraviolet light – to their arsenal in the continuing battle against food-borne pathogens.

Meat processors already go to incredible lengths to clean and sanitize their facilities, but are consistently searching for newer and better technology to sterilize the plant environment. Unfortunately, bacteria such as L. monocytogenes (“Listeria”) can sometimes survive in trace amounts for extended periods in food processing facilities, even though processors dedicate a full shift each day to cleaning disassembled equipment, conveyor belts, walls, ceilings and floors with high-pressure steaming water and powerful sanitizers.

Cleaning aside, a new study published in the journal Foodborne Pathogens and Disease confirmed that Listeria contamination could be significantly reduced on a broad range of conveyor belt surfaces by exposure to UV light. In a controlled environment, researchers introduced the pathogen to conveyor belts made from four different materials and then studied the effects of UV light application at two different intensities and two different time intervals (one and three seconds). After application of UV light for three seconds, the bacterial counts were reduced to below detection levels on three of the belts, and the survival populations on the fourth were considerably diminished. Click on the following link to view an abstract of the Listeria UV Study.

Notably, Listeria has always created unique challenges for industry because of its ability to grow and survive over a broad temperature range. In addition to its natural ability to propagate in cold temperatures, it can also sometimes persist, and be difficult to remove entirely from, food product contact surfaces.

This inherent resilience, of course, can also have a significant economic impact for processors. In 2009, for instance, seven voluntary and precautionary recalls (involving over 45,000 pounds of meat) were announced as a result of possible Listeria contamination. And as we recently reported, the average cost to food companies for a single recall can range as high as approximately $10 million, in addition to potential brand damage and lost sales.

In any event, while researchers and industry continue to assess this promising new data regarding the potential efficacy of UV light on different product contact surfaces, the American Meat Institute Foundation (AMIF) is also inviting pre-proposals on research for controlling Listeria on ready-to-eat meat and poultry products.

Hopefully, such collective efforts will illuminate a clearer path to new and effective interventions designed to eradicate, to the best extent possible, these and other persistent food-borne pathogens.

Contingency Planning And Crisis Management: Is Your Company Really Recall Ready?

Most food manufacturers, of course, hope that their persistent commitment to food safety will be enough to guarantee a safe product and completely eliminate any potential need for a future recall.

Despite such optimism, however, the possibility always exists (whether because of supplier issues or an internal problem completely unanticipated) that any company may someday be faced with an unexpected recall. For this reason, any food company that embraces a strong commitment to consumer safety, should also prepare in advance for the possibility of a product recall – no matter how remote.

We, of course, have worked with mutiple industry clients preparing for recalls, designing effective recall procedures, providing recall training, and managing crisis. We have also, in turn, worked closely with many clients through the late nights which follow the rare, but disappointing, realization that a voluntary and precautionary product recall may actually be warranted.

And, last month, I shared some additional perspective on crisis management and recall planning with Meatingplace (“Food Safety Attorney Advice For Companies Caught In A Recall”).  Moving forward, we plan to continue to offer our advice on these and other issues with contributions to additional print and electronic magazines such as the National Provisioner.  Watch for our monthly column begining in July 2010.

In addition to these existing and continuing contributions, a new industry report should further enhance our understanding of best practices for recalls. The report, “Recall Execution Effectiveness: Collaborative Approaches to Improving Consumer Safety and Confidence,” was conducted by Deloitte on behalf of the Food Marketing Institute (“FMI”), the Grocery Manufacturers Association (“GMA”), and GS1 U.S.

The FMI and GMA spearheaded the research because, for the reasons noted below, effectively managing recalls has become a “top priority for the entire industry:”

  • Rising Number and Complexity of Product Recalls. The number of product recalls has more than doubled since 1999 (with the greatest increase in recalls linked to Salmonella contamination and undeclared allergens). The average cost of a recall to companies is $10 million, in addition to brand damage and lost sales.
  • Growing Consumer Risk and Awareness. The consumption of raw products is increasing rapidly while the percentage of the U.S. population most at risk for foodborne illness is also increasing. A recent study found that 57 percent of consumers have stopped eating a particular food because of a food recall.
  • Significant Impact on Share Price and Market Value. The study found that companies with poor recall execution processes could see stock price declines of up to 22 percent within two weeks after a recall announcement.
  • Increasing Pressure From Trading Partners. Retailers are demanding a better recall execution process and given the number of recalls, are playing a more proactive role in quality assurance. As we reported earlier, Walmart set new standards for its beef suppliers.

In turn, the recommendations of the report cover three general areas: (1) communication and collaboration; (2) processes, organization and metrics; and (3) technology. Some of the communication initiatives include working with suppliers to conduct analysis on root causes of recalls, using multiple vehicles for notification of recalls (press releases, consumer loyalty cards, sales teams, etc…) and running mock recall exercises.

The report also urges companies to continuously refine their recall procedures, to strictly adhere to HACCP methodologies, and to invest early in employee training and planning for product replacement after a withdrawal. Finally, the report suggests that companies should also learn to understand and, to the extent possible, embrace new technology. In many instances today, recall processes are automated (and integrated) with systems such as the Rapid Recall Exchange and the Reportable Food Registry.

Ultimately, effective recall planning will remain a top priority for any company that manufactures and distributes food. In turn, we will continue to integrate many of these and other recommendations into our own planning guidelines. We will also be available to assist with your own recall planning and, whenever necessary, effective execution.

FDA Publishes New Guidelines For The Reportable Food Registry

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.