Beyond Statistics: What the FDA's RFR Report Means for Food Manufacturers

Last week, the FDA issued its first annual report on the Reportable Food Registry (RFR). The report provides statistics on the first year of the RFR (2240 entries, 229 "primary reports," a breakdown of the report by hazards, etc.).

Beyond the statistics, the FDA report should be noted by food companies for two reasons:

  1. Food Safety Plans

FDA Deputy Commissioner for Foods Michael Taylor says that “[s]everal key U.S. industries are already re-evaluating their hazard and preventive controls, core principles of the Food Safety Modernization Act recently passed by Congress. We also anticipate improved reporting as we continue our vigorous outreach to food facilities through federal, state, local and foreign agencies, to help us expand the positive effect of the RFR on the safety of the U.S. food supply.”

The new hazard analysis and preventative controls requirements in the Food Safety Modernization Act (FSMA) are not effective for 18 months following passage. Deputy Commissioner Taylor's comments suggest that industry standards may already be moving in that direction . To mitigate exposure and risk, FDA enforcement actions, product liability claims, supply chain contract claims and recalls, food manufacturers may want to consider updating and/or creating food safety plans that address the hazard analysis and preventative controls prescribed by the FSMA.

  1. Allergen Controls

The FDA reports undeclared allergens/intolerances accounted for 34.9 percent of the primary reports. Industry experts assert that the FDA believes that the industry does not in general have good control over the issue of undeclared allergens. These experts believe that the FDA will give special attention to the issue of undeclared allergens/intolerances in promulgating regulations under the FSMA's requirements for hazard analysis and preventative controls (see point 1 above). In anticipation of the FDA's concern, manufacturers should consider now how they can change manufacturing processes to address the undeclared allergen issue.

It's Official: The Food Safety Modernization Act Is Law. What Food Companies Need to Do Right Now

President Obama signed into law today the Food Safety Modernization Act (FSMA).

Companies with facilities subject to FDA jurisdiction should  take immediate steps to review and, where necessary, modify SOPs, policies and procedures.

For example, given the FDA's expanded access to business records, companies should set SOPs that anticipate (before a crisis occurs) what records they may have to turn over and what they may not. Food companies should take steps to protect confidential and proprietary information.

Companies also should anticipate now how they need to change their policies and approaches to mandatory recalls and whistleblower protections.

These parts of the legislation take effect today:

  • Stronger records access authority by FDA (FSMA § 101)
    • When FDA determines a "reasonable probability" of "serious adverse health consequences"
    • FDA can access records of other food affected in a similar manner
    • But FDA must show proper credentials and provide written notice
  • Mandatory recall authority (FSMA § 206)
    • FDA can order a recall if it finds a "reasonable probability" that
      1. food is adulterated or misbranded; and
      2. there may be serious adverse health consequences
    • FDA has to provide an opportunity for a voluntary recall
    • FDA will provide an informal hearing within two days of the order’s issuance
       
  • Increased frequency of inspections (FSMA § 201)
    • FDA will immediately increase the frequency of inspections
    • FDA will apply a risk-based approach to determine priorities
       
  • Whistleblower protection (FSMA § 402)
    • Protects employees who:
      • Provide information re violation of FDC Act ,
      • Testify, assist or participate in a proceeding re a violation, and/or
      • Object to "activity, policy, practice or assigned task" they "reasonably believe to be a violation"
         
  • Refused admission of imports if foreign facility refuses inspection (FSMA § 306)
    • Foreign establishments must allow entry to U.S. inspectors within 24 hours of requesting entry
    • Or imported food will be refused admission.

Future blog entries will discuss compliance with other provisions of the FSMA scheduled to be phased-in. If you are interested in a more detailed in-house discussion of the FSMA and its effect on your company, please let us know.

Unintended Consequences of FDA Mandatory Recall Authority?

For years, a debate has raged on the merits of vesting the FDA with mandatory recall powers. Mandatory recall is part of the food safety legislation that may or may not pass in this Congress, so it’s worth discussing. At present, the FDA lacks any power to order a recall. Its only legal authority is administrative detention and seizure.

Many, including some regulators, have argued against mandatory recall because it will result in less and less timely recalls. The argument that mandatory recalls may result in less timely recalls goes as follows:

  1. Under the current system (where FDA lacks mandatory recall authority), the onus is on the food seller to initiate the recall. If it doesn't issue a recall in the face of an FDA request to issue a recall, the food seller faces the dire consequences of FDA's bully pulpit  (press releases from FDA explaining why the food is unsafe) and possibly a seizure order. In the event of foodborne illnesses, ignoring an FDA request may also be grounds for punitive damages under the laws of some states;
  2. Because the onus under the current system is on the food seller (and not the FDA), the FDA frequently defers to the food seller's judgment when the facts surrounding a potential recall remain murky and uncertain. The FDA is not required to make a judgment about a recall and, for political reasons, often refrains from or delays making a decision as to whether to request a recall;
  3. Mandatory recall may reverse the dynamic and remove much of the onus from the food seller and put it on FDA. Mandatory recall may give the food seller cover if it chooses to delay or not issue a recall. If a food seller believes that its product is unlikely to be a threat to human or animal health, it might choose to wait until the FDA orders a recall. Under the current system, most food sellers will err on the side of caution when deciding whether or not to issue a recall. If the facts surrounding a recall are murky or uncertain, a mandatory recall regime may make it more prudent for a seller to wait for the FDA to decide. If the FDA is worried about being too trigger happy or quick to order recalls, a recall that may have been issued routinely under the current system may (ironically) never happen if FDA is vested with mandatory recall authority.


Mandatory recall authority, as its currently written in S. 510, may also change the threshold of when recalls are initiated. The threshold for a recall under sec. 206 of S.510 is described as when "there is a reasonable probability that an article of food . . . is adulterated . . . or misbranded . . . and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals."

The language of the statute closely follows what the FDA currently defines as a class I recall. But what about situations defined under the current scheme as class II or class III recalls? FDA's definition of a Class II recall is "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote." A Class III recall is "a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences." Query whether the statute lets foodd sellers off the hook for issuing recalls in Class II or Class III situations?

Note that FDA appears to retain some power even if there is not "reasonable probability" that the product will "cause serious adverse health consequences or death." S. 510 appears to lower the threshold for administrative detention by FDA by removing the condition that the food presents a risk of serious adverse health consequences. And, under S. 510, FDA would continue to have seizure power. The standard for seizure is simply if the food is adulterated or misbranded. One has to wonder whether FDA would use its limited resources on a seizure action in a class II or class III food recall where the chances of serious adverse health consequences are remote or not likely.

Listeria Recall Toolkit

The FDA recently took the relatively unusual step of obtaining a court-issued warrant to seize all cheese products at Estrella Family Creamery, a small, family-owned artisan cheese maker in Washington State. According to the United States Attorney's Office for the Western District of Washington, "the FDA asked Estrella to recall all cheese products. The company refused." The FDA requested the recall after both products and the manufacturing environment at Estrella tested positive for Listeria. A copy of the FDA form 483 report immediately pre-dating the recall request is here.

As the Estrella situation illustrates, the FDA is not just focused on large-scale manufacturing. As the FDA and USDA move to more risk-based allocation of resources, they are increasingly concerned about smaller operations and retail. Below are issues any food manufacturer must tackle when it comes to Listeria (much of this also applies to other food-borne pathogens).

What is Listeria?

Listeria monocytogenes is a bacterium that causes listeriosis, which primarily affects persons of advanced age, pregnant women, newborns, and adults with weakened immune systems. Though it affects only a small portion of the population, Listeria is the most deadly food-borne pathogen in the United States, killing 20-30% of all those who become seriously ill.

What should you do if your product tests positive for Listeria?

Assemble your well-rehearsed crisis management team immediately if a product tests positive (or if a regulator believes that your product may be contaminated). Members of the crisis management team; food safety personnel; company executives; and representatives from accounting, legal, supply chain, sales and customer service all are essential in the decision making process below.

Can you trace back and isolate contamination?

Quality assurance and food safety personnel need to answer trace-back issues as soon as possible. Can you determine the source of the contamination? Is it limited to one lot or a single day of production? How often are production facilities sanitized? How often are production surfaces swabbed for Listeria? Does the production facility re-use contaminated product from shift to shift?

Will you have to issue a recall?

Both the FDA and USDA lack mandatory recall authority. Though, as Estrella learned, the agencies do have the bully pulpit and the ability to get a court order to seize products. Because of the high mortality rate, regulators (federal and state) take any positive Listeria test result in food products extremely seriously.

If the food is considered a ready-to-eat product (RTE), a positive Listeria test will almost invariably lead to the FDA or USDA requesting a class I recall.

Even for a non-RTE food, a positive Listeria test will lead to a requested recall. If the agencies believe that the cooking instructions are clear, are easily followed by consumers and, if followed, will kill the bacterium, then the recall may be considered class II.

A primary difference between class I and II is that the class I recall will result in much greater publicity. For FDA-regulated facilities, a class I recall also triggers reporting and notification requirements under the Reportable Food Registry (RFR).

What does the Reportable Food Registry require?

RFR requires FDA-registered facilities to report to the FDA portal within 24 hours when there is a "reasonable probability that an article of food will cause serious adverse health consequences." As part of the report, information must be submitted "one step back and one step forward" in the supply chain. Once a report is submitted, the FDA will promptly alert your customers of the "reasonable probability" that your product will result in "adverse health consequences or death." If suppliers and customers are also FDA facilities, the FDA will also pressure those companies to report to the portal.

The ticking of the RFR's 24-hour reporting deadline forces a company to make snap decisions that might affect its entire business. While RFR reports can be amended or withdrawn based on new information, in the world of food products, the bell can almost never be unrung. A more lengthy discussion of the RFR can be found here.

How do you marshal your case with the regulators?

Assuming that you have information showing that contamination is limited (or non-existent), how do you convince the regulators? The FDA and USDA’s concern is public health (and politics). The regulators’ concern is not for your business.

Providing information to the regulators in a manner they perceive as credible, prompt and transparent is critical. Once the regulators lose confidence in your company's credibility and competence, the game may be over. In most cases, the most effective way to marshal your evidence is a well-prepared and credentialed crisis management team (e.g., food safety, quality assurance, supply chain, accounting, sales, legal, media, etc.).

The OchocincO's Misprint: This Wouldn't Happen with Flutie Flakes

There is a niche market out there for celebrity-endorsed food products that benefit charities. PLB Sports out of Pittsburgh appears to be a market leader in this niche, labeling products ranging from beef jerky to salsa to mustard with images and slogans relating to both individual sports figures and teams. Probably the most famous of these were Flutie Flakes, a breakfast cereal that supported an autism charity founded by Doug and Laurie Flutie in honor of their son. Usually, the product’s appeal—and its distribution—will be limited to the area where the team or athlete performs; Wayne Chrebet’s fans outside the New York area would have had to buy through PLB’s website.

Chad Ochocinco sponsored “OchocincO’s”, a honey nut toasted oat cereal, to benefit Feed the Children. Mr. Ochocinco, né Chad Johnson, is a flamboyant wide receiver for the Cincinnati Bengals, as renowned for his Twitter feed as his receiving prowess. His personal website will allow you to buy a t-shirt with the slogan, “That ain’t my baby.” He has 1.3 million followers on Twitter and 800,000 people “like” his Facebook page, which can garner over a thousand responses to him asking “what are y’all eating for lunch?” He does not lead a quiet life.

 

So in some ways it comes as no surprise that there was not just a misprint on the label of “OchocincO’s.” The problem apparently was a wrong toll-free prefix, which isn’t surprising since there are so many of them. Clearly someone, and not Mr. Ochocinco, failed to proof the copy on the box sufficiently before it was printed, the kind of mistake that happens every day. But this particular misprint would lead one, rather than to a number for more information about his selected charity, instead to a phone sex line. And the market for such cereals is of course young fans.

 

The boxes have been withdrawn from stores and the PLB website states that new boxes with the correct toll-free number will be printed.  Presumably, PLB and the printer will settle whose fault the mistake was. 

 

One imagines, though, that sales of OchcincO’s will soar because of the publicity from the mistake, greatly benefiting his charity. And somehow this just doesn’t seem like it would have happened with Flutie Flakes or David Eckstein’s Ecks’O’s. 

A Reportable Food Registry Toolkit

This article was first published on August 27, 2010 in Food Chemical News as part of its "On the Front Burner" series.

In its first year, the FDA’s Reportable Food Registry has proven itself to be a high-stakes game changer. The ticking of the RFR's 24-hour reporting deadline forces a company to make snap decisions that might affect its entire business (not to mention the health of its customers). Once a report is submitted, FDA will promptly alert your customers of the "reasonable probability" that your product will result in "adverse health consequences or death." While RFR reports can be amended or withdrawn based on new information, in the world of food products, the bell can almost never be unrung.

On the other hand, the civil and criminal consequences of failing to report when obligated to do so can be devastating. Companies that fail to comply with RFR requirements (even without intention not to comply) can be charged with felonies, and subject to fines and jail time for their executives. Those violating the RFR with intent are subject to greater penalties.

Assuming your company is a "responsible party" (meaning an "owner, operator, or agent in charge of a domestic or foreign facility" required to register under 415(a) of the FD&C Act) and already follows a HACCP plan, a GMP, GAPs, etc., what else can it do to prepare for and, if possible, prevent an RFR report? The answer is a lot. At minimum, here's what should be in any food company's RFR toolkit/standard operating procedures (SOPs):

Continue Reading...

Updated RFR Guidance from FDA: Possession Is More Than 9/10ths

FDA recently released updates to its Draft Industry Guidance for the Reportable Food Registry (“RFR”). The RFR, not rolled out until the fall of 2009, is still new to many companies. FDA, overwhelmed by the information coming through the RFR, is still trying to determine how to use the information submitted to the RFR and how to advise industry.

Among the more interesting clarifications in the May updates is the importance FDA puts on the possession of reportable food as a trigger for obligations under the RFR. For example, if produce is still in the field (contracted but not owned by a food seller) and tests positive for a pathogen, no reporting obligation accrues.

 

FDA’s hypothetical:

 

[F]ood facility that contracted with the farmer and tested the produce in the field is not required to submit a reportable food report, provided that the facility did not manufacture, process, pack, or hold the produce and therefore never became a responsible party with respect to the produce. However, if the field had been harvested and the contaminated produce had been moved to the food facility, the facility would have become a responsible party because it “held” the food and would be required to submit a reportable food report.

 

On the other hand, if the same contaminated produce is received on a company’s premises, stays in the trailer, tests positive and is rejected, a reporting obligation is triggered (even though the company did not take ownership of the product).

 

FDA’s description of this scenario in a Q and A format:

 

Q: Our manufacturing facility receives bulk trailer shipments of ingredients from our suppliers. A truck driver brings a trailer full of bulk ingredients onto our property, drops off the trailer, and drives away. However, as company policy, we do not off-load the trailers that are delivered to our facility or take ownership of the food in the trailers until after we test a sample of the food and determine that the food is acceptable. If we “reject” a shipment, i.e., return the food to the supplier, because the sample results indicate that the food is a reportable food, are we required to submit a reportable food report?

 

A: Yes, provided that you are a facility required to register with FDA under section 415(a) of the FD&C Act, you must submit a report for the food you determined to be a reportable food, even though you returned the food to your supplier. FDA considers that your facility “held” the reportable food because the trailers were no longer in transit once they were dropped off on your property. Thus, you are a responsible party with regard to the reportable food. Provided that the adulteration did not originate with you, you do not meet the criteria for the exemption from reporting in section 417(d)(2) (see Question E.3).

 

TAKE AWAY: If a company can set up a system to do its micro-biological testing before the product arrives on its premises or at its warehouse (public or private), it should. If faced with a reportable event, the reporting requires notification to FDA of one step forward and one step back in the supply chain even if the product is never distributed. Once a report is submitted to the RFR, a company should expect that the FDA will notify the company’s customers of the reportable event despite the fact that the customer never received product. FDA notification means the customer will be told that its vendor had contaminated product that rises to the level of class I recall though this may not actually be true.  Food sellers and manufacturers, therefore, would be wise to take steps to avoid being “stuck” with RFR obligations for contaminated product it does not own.

Take-Aways from November 3 Webinar: Making Good Marketing Claims: Product Labeling Pitfalls, Third-Party Certification and "Green Washing"

Tuesday, November 3, we held our second webinar in a three-part series on bringing sustainable food products to market. Thanks again to our presenters and attendees. The recorded webcast was archived and is accessible at this link. Click here to access a PDF copy of the presentation slides.

Take-aways from the second webinar include:

• With the exception of the FDA’s policy on “natural” claims, it has been silent on “green claims.”

• “Natural” could be hottest claim on the market but is becoming controversial. Food companies should continually monitor the marketplace to see which claims are drawing challenges.

• Food companies should pay attention to consumers union findings regarding eco-label credibility.

• While third-party certification may not help every food business, certification is a tool that supports your brand and your marketing/sales strategy.

• Retail leaders in sustainability, such as Burgerville, aspire for continuity of sustainability in each link in its supply chain.

• To understand the FTC green guidelines companies need to appreciate three key points: substantiation, specificity and qualification.

• To avoid “green washing” issues, food companies need to understand the complex matrix of federal, state, local and foreign statutes, regulations and guidelines governing “green” advertising.

I hope you can join me, Steve Marinkovich from Propel Insurance, my colleague at Stoel Rives, Anne Glazer, and Peter Truitt from Truitt Bros., Inc. on November 17, at 9 am PST, noon EST, (live Twitter feed at #sustainlaw) for the last webinar in the series as we discuss the following:

• Preventing and Dealing with Consumer Fraud, Unfair Trade and False Advertising Claims from Consumers and Competitors

• Real-Life Businesses Approaches to Sustainability, Product Labeling and Marketing

• Coping with Increased Risks of Food-Borne Illness from Local or Small Farm Products

• Insurance Coverage You Need, Think You May Have but Don’t Have or Think You May Want but Shouldn’t Get

Continue Reading...

Marketing Missive: FDA Issues Warning Letter to Procter and Gamble for Unlawfully Marketing Cold and Flu Medications Containing Vitamin C

By Guest Blogger Tyler Anderson

On October 29, 2009, the FDA issued a warning letter to Procter and Gamble notifying the company that its “Vicks DayQuil Plus Vitamin C” and “Vicks NyQuil Plus Vitamin C” are illegally marketed combinations of drug ingredients and a dietary ingredient. Both of the over-the-counter (OTC) medicines, which contain Vitamin C in addition to several drug ingredients, are marketed as treatments for cold and flu symptoms. The FDA issued the warning letter (1) to clarify that these single dosage form combinations of drug ingredients and dietary ingredients cannot legally be marketed because they have not been proven safe and effective, and (2) because the agency has previously determined that there is not sufficient data to show that Vitamin C is safe and effective in preventing or treating the common cold.

Under its OTC monograph system, the FDA allows some OTC drugs to be marketed without agency approval. The FDA found the two Vicks products did not comply with the applicable FDA monograph, and therefore the products must first be evaluated and approved under the agency’s new drug approval process before they can be legally marketed.

Some Take-Aways from ACI's 3rd National Forum on Food-Borne Illness Litigation

American Conference Institute (ACI) recently held its latest conference on food-borne illness litigation. The conference has been a fairly intimate gathering of the nation’s lawyers, insurers and experts involved with food-borne illness litigation.

This year, I had the privilege of moderating an in-house counsel “think tank.” The panel was composed of lawyers from a nice cross-section of food businesses: Yum Brands, Hormel, Fresh Express and SUPERVALU (though for each, food-borne illness litigation is a rare event)  A slide-deck from the panel can be found here.

Also among the presenters at this year’s conference were Center for Disease Control’s (CDC) Dr. Arthur Liang and USDA/FSIS representative Dr. Dan Engeljohn. Both presentations provided fascinating insight into changes afoot in food safety enforcement and policy at the federal level. Here are some of the take-aways:

“Outbreaks Waiting to Be Discovered” – Dr. Liang opined that, based on surveilled illnesses, most food-borne illness outbreaks are not presently discovered. He believes that recent data shows that there are perhaps 2-3 times more outbreaks nationally than what’s been uncovered over the last few years.

• Food Safety Progress Being Undone by Retail Deli Operations – FSIS says there has been a “steady increase in risky behavior at the retail level.” According to Dr. Engeljohn, budget authority is being sought to intervene with retailers, particularly smaller supermarket deli operations.

Negative Tested Product Can Be Considered Adulterated - FSIS will be issuing a policy soon that for the first time will consider a “negative tested product to be determined adulterated” under circumstances where an associated product tested positive for pathogens.

Non-0157 STECs - FSIS will be finalizing methodology to detect non-0157 Shiga Toxin-Producing Escherichia coli (STEC).

Why Are Food-borne Organisms Associated with Beef?

 USDA’s Be Food Safe Twitter Feed circulated its Fact Sheet titled “Beef . . . from Farm to Table.” First published a few years ago, this might be of interest to businesses involved in the sale, marketing, labeling, and/or packaging of beef. The article is a helpful primer on the history of beef, current industry practices, USDA’s role in inspection, consumer trends, cooking times, storage times, and food-borne illnesses associated with beef.

Sustainability and Consumer Confidence in Food Safety

For food sellers interested in promoting a “sustainable” brand and inspiring food safety confidence in their consumers, meet Food Alliance. Food Alliance “is a nonprofit organization that certifies farms, ranches and food handlers for sustainable agricultural and facility management practices.” It bills itself as “the most comprehensive certification program for sustainably produced food in North America.”

I’ve recently joined the Food Alliance Board of Directors (in fact, I’m headed to Portland today for a board meeting). My hope is to assist Food Alliance in becoming more widely accepted and mainstream. Credible third-party certification, such as Food Alliance provides, offers a transparent pathway to sustainability of our food supply and consumer confidence in food safety.

Food Alliance takes a holistic approach that is broader and more dynamic than organic certification, which does nothing to address food contamination from pathogens such as Salmonella, E. coli, and Listeria (in fact, many experts believe that organically grown food may be more likely to be contaminated by these pathogens). By way of example, Food Alliance certification standards, among other things, address “soil and water quality,” “ensure the health and humane treatment of animals,” “conserve energy and water,” and “ensure quality control and food handling safety.”

For more on why a holistic, independent third-party certification correlates with food safety (and accompanying consumer confidence), I’d suggest reading this op-ed piece co-authored by Food Alliance Executive Director Scott Exo, which was written earlier this year in the wake of the PCA peanut recall.

Ivar's Turkey Soup Recall

Ivar Haglund was a Seattle legend.  In these parts, he was known only by his first name, the way you can refer to "Michael" when you're discussing basketball and people know you mean Michael Jordan.  His food is at Sea-Tac Airport, Safeco Field and Qwest Field.  From 1964 until it was discontinued for this year, he sponsored one of the largest fireworks displays in Seattle on the Fourth of July, which was called Fourth of Jul-Ivar's.  Every city, I imagine, has someone like Ivar, but he was ours.

Ivar's is known for seafood.  The original restaurant was called Acres of Clams, right on the waterfront.  His landmark Salmon House is on Lake Union next to Dale Chihuly's house and studio; you can sometimes see Chihuly with his trademark patch walking past Ivar's. 

I had no idea Ivar's made turkey soup until it was recalled.

You couldn't buy Ivar's turkey soup, more particularly "turkey-flavored egg noodle soup with turkey meat", even before it was recalled.  It is only sold to institutions.  I imagine it is a way of increasing revenue from by-products that might otherwise have to be thrown out or recycled.

So what was wrong with the soup?

Absolutely nothing.  Bring it by and I'll happily consume it (though not expecting it to be a high-end product, given the market).

Why then the recall?  Because the packaging didn't indicate that it contained milk and milk is a known allergen

Ordinarily, I might note also that vegans don't ingest milk products either, so the mislabeling might cause an issue with them.  And of course Jewish dietary laws prohibit the mixing of milk with poultry.  So in both cases, there might have been mislabeling issues unrelated to milk's status as an allergen.  However, vegans don't eat turkey anyway, and observant Jews only eat turkey that has been properly ritually slaughtered, as would be evidenced by a rabbi's stamp on the package, which I somehow doubt Ivar's had.  Incidentally, the rabbinical kosher stamp here in Seattle incorporates a Space Needle into the K

More on Pistachios and Setton Farms

As I predicted yesterday, the pistachio recall is affecting more products.  The FDA has a nice list

Meanwhile, the Setton Farms website, as of 1:30 pm PDT today, still has no information on the recall. 

Yes, We Have No Tomatoes

By Guest Blogger Richard Goldfarb
Sunday, at a local restaurant, I saw a sign saying that there would be no fresh sliced tomatoes on my burger. Although it is quite clear that there are safe tomatoes available, the FDA has encouraged restaurants simply to cease selling them. This makes a lot of sense: rumors fly so rapidly and irresponsibly. Though, individual restaurants may take different steps; those that pride themselves on knowing the source of their heirloom tomatoes should be advertising that fact.

The problem is salmonella, in particular a strain called “saintpaul.” The FDA identified salmonella in tomatoes as a significant risk a year ago.  Thus, they had the infrastructure in place to monitor and deal with the significant number of reported outbreaks this year. So far, no one knows the source of the problem, and all the FDA can do at this point is to list those tomatoes that have not been associated with the outbreaks:

• Cherry tomatoes
• Grape tomatoes
• Tomatoes sold with the stems on
• Homegrown tomatoes

In addition, the FDA lists those tomato-growing areas that have been ruled out in the outbreaks. This doesn’t mean that tomatoes grown in those areas will always be safe, but that they have not been linked to this outbreak. The FDA also reiterates its advice on the safe handling of fresh tomatoes and other fresh fruits, both in restaurants and at home. The CDC website provided a nice summary:

• Refrigerate within 2 hours or discard cut, peeled, or cooked tomatoes.
• Avoid purchasing bruised or damaged tomatoes and discard any that appear spoiled.
• Thoroughly wash all tomatoes under running water.
• Keep tomatoes that will be consumed raw separate from raw meats, raw seafood, and raw produce items.
• Wash cutting boards, dishes, utensils, and counter tops with hot water and soap when switching between types of food products.

The problem isn’t limited to the United States; New Zealand tomatoes have been implicated as well, and banned in Hong Kong.  It was nice to know that the tomatoes we had with dinner last night were doubly safe: they were hothouse tomatoes sold with the stems on, and they were from British Columbia, one of the locales ruled out by the FDA.

CDC Believes That Risks Associated with Leafy Greens Have Been on the Rise

Following the high-profile leafy greens E. coli outbreaks in 2006, CDC started studying the trends. It concluded that “during 1996 2005 leafy green consumption increased 9% and leafy green-associated outbreaks increased 39%,” according to a recent article on ScienceDaily. Therefore even taking into account the increase in leafy greens consumption, associated food-borne outbreaks are on the rise. This is consistent with general trends, as indicated in my recent magazine article in Cooperative Grocers.

Although there is no way to eliminate risk, grocers, restaurants, and produce suppliers should conduct ongoing reviews of their food safety, audit, supplier, and insurance programs to ensure that everything that can be done is being done to mitigate or shift risk.

Importance of Experts At Outset of Outbreak

A few weeks ago, I gave a presentation at a CLE seminar about how to use and challenge expert witnesses in a food case. One of the interesting discussions that occurred during my talk was about the importance of retention of experts at an early stage, even before health department officials finalize their findings.

Given the limited resources of most state and local health departments, I have always believed there is little to lose by offering the assistance of credible and known epidemiologists, microbiologists, etc. Additional resources in an outbreak investigation (and, therefore, additional investigation) can mean the difference between the health department pointing at your client and the health department pointing at another source. Several other defense lawyers, and, surprisingly, state health department officials, agreed. Examples of successful early intervention were elicited.

FSIS to Start Posting Plant Testing Data

I wrote earlier about Dr. David Goldman's talk at the ACI Food-Borne Illness Litigation conference and his comments regarding supermarkets. Another significant issue concerns posting by FSIS of microbiological testing results from meat and poultry plants on its Web site. Continue Reading...

Loyalty Cards and Product Recalls

 

Last week, a supermarket chain, Wegmans, learned that an employee working in the produce department contracted Hepatitis A. Like many supermarket chains, Wegmans, based in Rochester, New York, maintains a customer loyalty card system.  According to the Buffalo News, , “the store plans an outreach to its customers they know purchased potentially affected produce by using Shoppers Club data to contact them via automated telephone calls.”

Loyalty cards were not designed to assist grocers in providing recall and food safety information. Many companies, in fact, face hardware and software problems in using their loyalty card databases to notify customers about issues with products purchased with the card. Many grocers do not require complete or accurate contact information.  Privacy concerns are also a factor. A grocer does not know when it contacts a customer whether it is speaking to the customer or to someone else in the household.  It is not hard to imagine a situation in which a household member does not want purchases (e.g., birth control, alcohol, or tobacco) or health conditions known to others in the household. 

On the other hand, some believe that customers expect grocers to use their loyalty card databases for just this purpose. Traditional means of recall notice--press releases, signage in the stores, etc.--may not be as rapid as a phone call or email. Timing can make the difference between recalled food being consumed or not.

No matter whether grocers follow Wegmans’ policy of personal notification, a good business practice (and litigation avoidance tactic) may be for a grocer to disclose clearly to customers its policy about using the loyalty card information to provide notice of product safety issues. For grocers who use the database to phone or email consumers, a clear policy will avoid the golden rule that “no good deed goes unpunished.” For grocers for whom personal recall or safety notices are impractical or constitute privacy violations, a clear policy will create clear expectations and may mitigate against litigation.