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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 Nearly ten months later, with mixed reactions, the guidance has been revised: “Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007”.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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When I was growing up, going to a restaurant was a rare treat.

I would look forward to savoring a greasy burger and fries, or a steak and baked potato. Maybe I would even be fortunate enough to get soft serve swirled in a dish for dessert. Times have changed though. Today, one-third of all meals are eaten in restaurants.

I now travel quite a bit, so restaurants have become more of a staple for me. And, although all of us try as often as possible to dish up homemade food for our families, it’s not an easy task in today’s fast paced world. Thus, while I still look forward (on most days) to eating great tasting restaurant food, even if not the most nourishing, I also appreciate recent efforts to enhance the number of healthy choices on restaurant menus.

The President has already committed to enhancing our national food safety system through the Food Safety Working Group, and has supported new initiatives to educate consumers about the importance of food safety. And, now, the First Lady is tackling food nutrition and health. Indeed, last week, First Lady Michelle Obama addressed the National Restaurant Association ("NRA"). She called on restaurants to “create healthier versions of the foods we all love” and to decrease portion sizes. Fighting childhood obesity has long been a cause of Mrs. Obama, and her “Let’s Move” campaign aims to educate parents about nutrition, present healthier foods in schools, improve access to healthy food and increase physical activity.

Although none of us should tell restaurant owners what to offer on their menu, the First Lady did leave the NRA with some food for thought. Consumers have already been requesting more healthy alternatives, and assuming Mrs. Obama’s “Let’s Move” initiatives are successful, awareness and new demand will only increase. Obviously, restaurants want to continue serving up one-third (and perhaps more) of our daily meals.

In any event, I would like to commend the many restaurants that have already made great strides in providing healthy (and safe) food to their patrons. Thanks for giving us the choice between indulging in a treat or moderating in lighter, yet still tasty, fare.

With that said, it's lunchtime, and I’m going to go get a greasy burger and fries.

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How clean is your kitchen?

Probably not as sanitary as you think.

A recent study completed by the Los Angeles County Department of Public Health (“LACDPH”) found that only about 61% of home kitchens would receive an “A” or “B” grade if inspected like a restaurant, and at least 14% would flunk.

To put this in perspective, 98% of L.A. County restaurants received an A or B following inspections between 2006 and 2008, and any restaurants that failed were subject to closure.

There is an interesting background leading up to this study. If you have ever been to an L.A. County restaurant, then you have probably noticed a placard posted by the door with a fairly large A or B or crimson C. Beginning in 1998, L.A. County restaurants were required to display their health inspection grade to patrons. The result of this disclosure? By the end of 1998, the number of hospitalizations for food-borne illness was down by 13% in L.A. County.

The LACDPH enhanced these food safety efforts by introducing the Home Kitchen Self-Inspection Program in 2006 to encourage food safety practices in the home.

The program included an online Food Safety Quiz comprised of 57 questions developed around the USDA food safety principles of clean, separate, cook and chill. The quiz asked about food handling and preparation practices at home, but the questions were similar to the standards used to evaluate restaurants.

Approximately 13,000 adults voluntarily completed the quiz between 2006 and 2008; 34% received an A, 27% a B, 25% a C, and 14% failed. Thus, about one in seven homes deserved an “F” placard placed on their front door.

Granted, this study has some limitations. The quiz was only available online and in English. And obviously, the letter grades are based on respondent self-reports and not actual physical inspections of the home kitchens.

However, one such limitation makes the results even more frightening. People who are more interested in, and possibly more knowledgeable about, food safety were more likely to have taken the quiz. Letter grades aside,

• 64% of quiz respondents admitted that when cooking big portions of food to serve later, they did not rapidly cool and store it in a refrigerator;

• 36% of respondents did not have a properly working thermometer in their refrigerator; and

• 33% of respondents did not store raw meat below all other foods in the refrigerator.

Studies continue to evidence there is much more work to be done in educating our consumers. This study referenced how web-based learning tools (i.e. Meat Safety, Meat Matters Info, FSIS) are becoming ever more important in education.

In any event, I suppose, it’s fitting that the research was released during National Food Safety Education Month. Thus, moving forward, let's work to heighten awareness of food safety practices and help make not only the places we produce food, but also the places we prepare it, more sanitary and safe.

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This month marks the 15th annual National Food Safety Education Month!

The National Restaurant Association initially created National Food Safety Education Month in 1994 to enhance food safety education in the restaurant and food service industries. Today, food safety instruction is given special highlight each September by many sectors of the food industry.

This week the American Meat Institute (AMI) described its campaign aimed at educating consumers on the proper handling, cooking and storing of meat and poultry products. AMI released a 60-second radio piece nationwide, reminding consumers of the importance of meat and poultry thermometers and directing them to www.meatsafety.org. The radio piece can be heard here.

Developed by AMI, meatsafety.org offers safe handling guidelines and information on a variety of other topics such as food-borne illness statistics and food safety publications. Consumers can test their meat and poultry IQ on the site with a quiz (let’s just say I scored well). Meatsafety.org is a comprehensive site that also offers, among many other things, an overview of the U.S inspection system and AMI’s position on hot topics like antibiotics and meat myths.

AMI also built another great site, www.meatmattersinfo.org, to help consumers partner with them in food safety. Consumers can download the free brochure “Safe Handling of Meat and Poultry Products.” Further, AMI’s YouTube Channel, the Meat News Network, has many consumer-focused education videos, including video of safe handling practices.

In addition to the AMI, the following websites contain valuable materials to easily teach anyone about food safety and National Food Safety Education Month:

• ServSafe National Food Safety Education Month;
• FSIS Food Safety Education;
• Facebook – National Food Safety Education Month;
• Fightbac.org.

AMI consumer survey data indicated that only 34% of consumer respondents knew safe cooking temperatures, and only 1 in 5 consumers use a thermometer when cooking meat. These numbers are wholly unacceptable; consumers are the last line of defense against food-borne illness.

We applaud the the efforts of each of these initiatives, and remind everyone to boldly share their food safety knowledge.

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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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