While the United States has one of the safest food supplies in the world, every year an estimated one in six Americans gets a foodborne illness (also called food poisoning), but you can help protect yourself and your family by using the basic principles of food safety.

The Food and Drug Administration offers Food Safety Education Month resources all year round for consumers and educators on a variety of subjects, including learning who is most at risk for foodborne illnesses and how to avoid food waste while maintaining food safety.

The centerpiece of these resources is advice on safe food handling. This year, FDA’s program is refocusing on the four basic messages of food safety at home:

Clean

• Wash your hands with warm water and soap for at least 20 seconds before and after handling food.
• Rinse fresh fruits and vegetables under running tap water, including those with skins and rinds that are not eaten. Scrub firm produce with a clean produce brush.
• Wash your cutting boards, dishes, cooking tools, and countertops with hot soapy water after preparing each food item.

Separate, Don’t Cross-contaminate

• Raw meat, poultry, eggs, seafood, and flour should not come in contact with foods that do not need to be cooked before eating. Keep them separate while shopping, storing, and cooking.
• Use one set of cooking tools for raw meat, poultry, eggs, seafood, and flour, another set for foods that are already cooked or will not be cooked.
• Don’t reuse marinades used on raw foods unless you bring them to a boil first.
• Don’t cross-contaminate by washing raw poultry or meat. It can spread germs around the kitchen which may transfer to food.

Cook

• Make sure food is cooked to a safe internal temperature by checking with a food thermometer before you eat it. A safe internal temperature is important protection against germs in or on most cooked foods.
• Follow package directions on baking mixes and other flour-containing products for correct cooking temperatures and specified times.

Chill

• Refrigerate or freeze meat, poultry, eggs, seafood, and other perishables within two hours of purchasing. Refrigerate within one hour if the temperature is above 90 degrees F. This two-hour rule also applies to serving prepared cold or hot food on a picnic or buffet style party, because the longer food sits at room temperature, the more bacteria multiply.
• Never thaw food at room temperature, such as on the countertop. There are three safe ways to defrost food: in the refrigerator, in cold water (change water every half hour to make sure it stays cold) and in the microwave. Food thawed in cold water or in the microwave should be cooked immediately.
• Divide large amounts of leftovers into shallow containers for quicker cooling in the refrigerator.

Additional Information

• See Safe Food Handling: What You Need to Know, as well as the many other downloadable food safety publications and videos at CFSAN’s Education Resource Library.
• See FDA’s New Era of Smarter Food Safety page to learn how FDA is taking a new approach to reducing the number of foodborne illnesses.

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“We are building on the longstanding partnership for the U.S. and Mexico to work together to contain outbreaks of foodborne illness and lessen consumer exposure to foodborne hazards. As we approach the 200th anniversary of U.S.-Mexico relations, keeping this partnership strong is more important than ever,” said Frank Yiannas, the FDA’s deputy commissioner for food policy and response.

“Our food supply is global, and no single country can achieve its food safety goals alone. Our shared goal is to proactively use modern technologies, tools and approaches to help protect the global food supply.”

Mexico is a primary supplier of fresh fruits and vegetables to the U.S. FDA data shows that about one-third of all agency-regulated human food imported into the U.S. is from Mexico, including 60% of our fresh produce imports.

This year, the FDA, SENASICA and COFEPRIS convened in Mexico City to complete several tasks that included: visiting a farm to implement food safety practices, including traceability, and to observe unique growing and harvesting practices; meeting with industry to learn more about their food safety efforts and to discuss collaborations, and lastly; holding the Annual FSP Meeting.

During this year’s meeting, the agencies reported tangible progress in each workgroup and discussed plans for the coming year to further food safety in both countries. Reported progress and outcomes included:

• Exchanging key information and plans that guided efforts to address a 2021 Salmonella outbreak, which was linked to bulb onions from the State of Chihuahua, Mexico. The three agencies collaborated to share information on their respective onion plans to guide response and prevention efforts such as: SENASICA’s mobile laboratory for assessing field samples from inspections; the FDA’s Foreign Supplier Verification inspections for onion importers; and, hosting technical meetings with Mexican onion growers and packers to learn more about their production practices. The FDA and SENASICA also collaborated with the papaya industry on the verification of the papaya checklist, a tool to further encourage the adoption of food safety best practices for papaya.
• Discussing progress on the implementation of FDA’s Cyclospora methodology distance training plan based on the BAM Chapter 19b method for detecting Cyclospora cayetanensis in produce samples for SENASICA and COFEPRIS. Competency in the methodology will expand international capacity for detecting Cyclospora cayetanensis.
• Establishing a new commitment for Whole Genome Sequencing (WGS) where SENASICA and the FDA have committed to a data sharing agreement to upload 100 sequences (food and environmental) to the GenomeTrakr network. This is an important contribution to the GenomeTrakr network and allows both countries to identify and respond to outbreaks faster and with more precision, helping to mitigate the number of consumers impacted.
• Establishing revised Binational Outbreak Notification Protocol to improve timely and effective communication by: sharing WGS data, including a reference to the laboratory methodology for detection, and using the FDA CORE Investigation Table to share publicly available epidemiologic information. As a next step, the FDA, SENASICA and COFEPRIS are working on a new model for conducting inspections involving participation by all three regulatory agencies where a food safety issue is suspected.

Additionally, during this year’s meeting, the FDA, SENASICA and COFEPRIS reviewed Produce Safety Rule (PSR) trainings they had facilitated, including those with cilantro growers in Puebla, avocado growers in Jalisco and bulb onion growers in Chihuahua. The three agencies also worked with EMEX, a mango association, to conduct three PSR trainings for mango producers in Sinaloa, Nayarit and Jalisco.

The FDA also provided outreach to SENASICA and COFEPRIS personnel about the FDA’s proposed Agricultural Water rule: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water.

“Within the framework of the celebration of 200 years of diplomatic relations between Mexico and the United States, we are honored to be FDA partners,” said Francisco Javier Trujillo Arriaga, director in chief of Senasica. “We know the importance of what is at stake, and we are convinced that the success stories we have had with producers and marketers of different types will generalize to other environments.”

The FDA, SENASICA and COFEPRIS will continue to work closely together to support training for food producers, preventing and responding to foodborne illness outbreaks, and developing and implementing plans to enhance food safety for mutual public health.

“In this annual meeting, various activities were carried out that have contributed to a better understanding of the safety systems of both countries,” said federal commissioner for Cofepris, Alejandro Svarch Pérez. “In addition, they highlighted that they have allowed for a greater rapprochement between the main actors in the food production chain, with the aim of coordinating efforts and taking advantage of the experience and knowledge available.”

The FDA is committed to collaborating and using every tool available to help create a healthier, smarter food supply.

Editor’s note: For news about the congressional report, please click here.

The FDA takes exposure to toxic elements in the food supply extremely seriously, especially when it comes to protecting the health and safety of the youngest and most vulnerable in the population. Toxic elements, such as arsenic and lead, are present in the environment and may enter the food supply through soil, water or air. Because these elements occur in the environment, currently they cannot be completely avoided in the fruits, vegetables, or grains that are the basis for baby foods, juices, and infant cereals made by companies or by consumers who make their own foods. They also cannot be completely avoided by using organic farming practices. Our goal is to reduce exposure to toxic elements in foods to the greatest extent feasible and to further advance progress in this area through more research and enhanced collaboration among stakeholders.

FDA regulations and monitoring help to ensure the safety of baby foods sold or manufactured in the United States.

While the report released on February 4, 2021 by the U.S. House of Representatives Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy raises important questions on what more can be done to reduce toxic elements in baby foods, the FDA has been actively working on this issue using a risk-based approach to prioritize and target the agency’s efforts. Consumers should know that FDA scientists routinely monitor levels of toxic elements in baby foods, along with other foods consumed in the country’s diet, through the Total Diet Study. Further, the FDA also monitors baby food under the FDA’s compliance program for Toxic Elements in Food and Foodware, and Radionuclides in Food and through targeted sampling assignments.

When toxic elements in food present a potential health concern, the FDA takes steps to reduce levels, such as using science to set action levels, making data public, and working with industry on identifying effective mitigation strategies.

For example, FDA sampling of infant rice cereal since 2011 has shown that manufacturers have made significant progress in reducing arsenic in infant rice cereal products through selective sourcing and testing of rice and rice-derived ingredients (e.g., rice flour). This progress has been advanced by the FDA through final guidance to industry on action levels. Because of these efforts, infant rice cereal on the market now is safer than it was a decade ago and we expect that by using emerging science and good manufacturing practices companies will continue to reduce levels of arsenic in infant rice cereal.

Firms and individuals who manufacture or sell food have a legal responsibility under the Federal Food, Drug, and Cosmetic Act to ensure the safety of their products. The FDA reviews information and takes action on a case-by-case basis. If the FDA finds that a product violates the law, the agency takes steps to stop the product from being imported, takes court action to stop its sale or recalls it if it is in the domestic market.

For example, on January 15, 2021 the FDA ordered a U.S. company that had been put under court order for distributing adulterated food to stop distributing adulterated juice products containing potentially harmful levels of the toxic element inorganic arsenic and the mycotoxin patulin, until the company complies with the Federal Food, Drug, and Cosmetic Act and other requirements in the court order. The FDA has also worked with several manufacturers whose products contained elevated levels of toxic elements, to remove them from the market. In addition, between 2019-2020, approximately 65 import actions kept products with potentially elevated levels of toxic elements from entering the U.S.

The FDA currently has multiple ongoing Import Alerts for toxic elements in food, including for arsenic in fruit juice, bottled water and dietary supplement products and for lead in candy, dried fruits, spices, dietary supplements, and other foods.

The FDA is continuing to work to ensure both domestic and imported foods meet the same standards for toxic elements.

For example, FDA scientists help ensure there are internationally-recognized standards to reduce the levels of toxic elements in foods by participating in Codex Alimentarius, an international food standard setting body of the Food and Agriculture Organization and World Health Organization. As part of FDA’s work at Codex, our scientists have been instrumental in setting maximum levels and establishing codes of practices for toxic elements including lead, arsenic, cadmium, and mercury. Levels set by Codex, although not binding, can inform our regulatory decisions.

FDA provides consumers with actionable advice to limit exposure to toxic elements from food.

For example, consistent with the Congressional report’s recommendations, the FDA has communicated advice about the importance of feeding infants a variety of grain-based infant cereals. Rice cereal fortified with iron is a good source of nutrients for infants, but it shouldn’t be the only source and does not need to be the first one.

The FDA will continue working with our federal partners, industry and consumer and health advocates on our shared goal of reducing consumer exposure to toxic elements from food.

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Among those in Hurricane Delta’s path in the Gulf Coast and the Southeast U.S. are farmers and their fields of crops grown for human consumption. The U.S. Food and Drug Administration’s Center for Food Safety and Applied Nutrition has several resources to help growers who may be affected by the impacts to their crops from severe weather conditions.

The FDA’s Guidance for Industry: Evaluating the Safety of Flood-affected Food Crops for Human Consumption provides the information that producers can use as they assess potential damage to their food crops. This guidance is an important resource for the growers who produce and market these crops, as they are responsible for assuring the safety of flood-affected food crops for human consumption.

The FDA reminds harvesters that generally, if the edible portion of a crop is exposed to contaminated flood waters, it is considered “adulterated” under the Federal, Food, Drug and Cosmetic Act and should not enter the human food supply. This applies to all food crops including underground crops (e.g., peanuts, Copotatoes).  For crops that were in or near flooded areas but where flood waters did NOT contact the edible portions of the crops, the growers should evaluate the safety of the crops for human consumption on a case-by-case basis for possible food safety concerns.

Sometimes, crops that have been harvested and then subsequently deemed unsuitable for human use can be salvaged for animal food. For more information please see CVM Update: Resources for Animal Food Producers in Puerto Rico and the Southeastern U.S. Affected by Hurricane Isaias.

Reconditioning requests for contamination events occurring in Alabama, Louisiana, Mississippi or Tennessee:

• Steven Barber, 513-679-2700 x2116
• Toniette Williams, 513-679-2700 x2160
• Lindsay Bertling, 615-366-7815

Reconditioning requests for contamination events occurring in Arkansas, Oklahoma or Texas:

• Edmundo Garcia, 214-253-5201
• Karen Daugherty, 214-253-5228
• Jane Broussard, 214-253-4925

We encourage growers to work with state regulators and local FDA offices to assess their unique situations and to take into consideration all possible types and routes of contamination from flood waters in determining whether a particular crop is adulterated.

For more information:

• Safety of Food Affected by Hurricanes, Flooding, and Power Outages

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This month take an active role in preventing foodborne illness, also known as “food poisoning.” The federal government estimates that there are about 48 million cases of foodborne illness annually – that’s about 1 in 6 Americans each year. Each year, these illnesses result in an estimated 128,000 hospitalizations and 3,000 deaths. Following simple food safety tips can help lower your chance of getting sick.

National Food Safety Education Month Resources

FDA has resources to help encourage you and your community to put food safety first.

• Safe Food Handling – Follow these four key steps to food safety.
• Food Safety in Your Kitchen – Get tips for food safe shopping, storage, and meal prep.
• People at Risk of Foodborne Illness – Learn what groups are more at risk for foodborne illnesses.
• Food Safety for Pregnant Women ­– Find food safety information for before, during, and after pregnancy.
• Everyday Food Safety for Young Adults – Learn about food safety whether you’re cooking at home, dining out, or eating ready-made meals on the go.
• Education Resource Library – Find printable educational materials, videos, and more!
• Continuing Medical Education Program – Learn how to identify, treat, and report foodborne illness.
• Science and Our Food Supply – Bring food science into your middle and high school classrooms.
• Consumer Food Safety Educator Evaluation Toolbox and Guide – Get tips, tools, and examples to plan, develop, and evaluate food safety programs and activities.

Social Media Resources

Help us to spread the word about the importance of food safety. Use these Twitter and Facebook messages to show your support for Food Safety Education Month and to encourage your community to keep food safe.

Sample Tweets
Learning the do’s and don’ts of food-safe meal prep can help avoid foodborne illness. Start in the kitchen, putting #foodsafety into practice to protect you and your family. http://go.usa.gov/xV2YK #NFSEM

#CLEAN – Rinse fruits and veggies under running water. Slicing or dicing? Scrub ‘em anyway– germs can jump from rinds to the insides during cutting and peeling. https://go.usa.gov/xVT3t #NFSEM

#COOK – When you’re cooking you can’t tell if it done just by looking. Use a food thermometer to make sure it’s safe to eat. https://go.usa.gov/xVT3d #NFSEM

#SEPARATE – No yolking around! Storing eggs on the fridge door can expose them to uneven temperatures. Here’s where you should store them instead: https://go.usa.gov/xVT3G#NFSEM #FoodSafety

#CHILL – Keep your cool – especially when it comes to grocery, leftovers, & food delivery items. Your fridge should be 40 degrees F or less, the freezer zero degrees F or less. https://go.usa.gov/xVT3A#NFSEM

Sample Facebook Posts
Think food poisoning is just a little upset tummy and will pass? Not always. Sometimes foodborne illness is serious & even life threatening. We’ve got short video stories from 3 people that speak from experience! https://go.usa.gov/xV2ry National Food Safety Education Month

Looking for free food safety information? Whether a consumer, teacher of middle & high school students, or a food service worker, you’ve come to the right place! Check out our resource library to find free education materials, printable posters, and videos. https://go.usa.gov/xPCJENational Food Safety Education Month

Download animated GIFs

Remember and follow these 4 key steps from @FDAfood to follow and keep your family safer from food poisoning

• Clean
• Separate
• Cook
• Chill
  http://go.usa.gov/xV2YK #NFSEM

You wash apples, tomatoes and strawberries before you eat them, but what about cantaloupes, avocados and kiwi? https://go.usa.gov/xVT3t Hint: the answer is YES. #NFSEM

No yolking around! Storing eggs on the fridge door can expose them to uneven temperatures. Here’s where you should store them instead: https://go.usa.gov/xVT3G #NFSEM #FoodSafety

When you’re cooking you can’t tell if it done just by looking. Use a food thermometer to make sure it’s safe to eat. https://go.usa.gov/xVT3d #NFSEM

Keep your cool – especially when it comes to grocery, leftovers, & food delivery items. Your fridge should be 40°F or less, the freezer 0°F or less. https://go.usa.gov/xVT3A #NFSEM

Resources
Looking for #foodsafety information? Whether a consumer, teacher of middle and high school students, or a food service worker, you’ve come to the right place!
Check out @FDAfood’s resource library to find free printable materials and videos. https://go.usa.gov/xPCJE #NFSEM

(To sign up for a free subscription to Food Safety News, click here.)

Remember to pack your picnic basket with food safety in mind, as foodborne bacteria that cause food poisoning multiply faster in warm weather.

Follow these tips to keep your food safe when eating outdoors:

Before your picnic

• Defrost meat, poultry, and seafood in the refrigerator or by submerging sealed packages in cold water. You can also microwave-defrost, but only if the food will be grilled immediately afterward.
• Marinate foods in the fridge not the countertop. Never reuse marinade that touched raw foods unless you boil it first or set some of the marinade aside before marinating food to use for sauce later.
• Wash all produce before eating, even if you plan to peel it. The knife you use to peel it can carry bacteria into the part you eat. Fruits and vegetables that are pre-cut or peeled should be refrigerated or kept on ice to maintain quality and safety.
• If your picnic site doesn’t offer clean water access, bring water or pack moist towels for cleaning surfaces and hands. Don’t forget to pack a food thermometer!

Packing coolers

• Place food from the refrigerator directly into an insulated cooler immediately before leaving home.
• Use ice or ice packs to keep your cooler at 40 degrees F or below.
• Pack raw meat, poultry, and seafood in a separate cooler, or wrap it securely and store at the bottom of the cooler where the juices can’t drip onto other foods. Place beverages in a separate cooler; this will offer easy drink access while keeping perishable food coolers closed.
• Avoid loading coolers in the trunk of the car, as it can collect heat. Once at the picnic site, keep food in coolers until serving time (out of direct sun) and avoid opening the lids often.

Grilling

• Have clean utensils and platters available. Cook meat, poultry, and seafood to the right temperatures ─ use a food thermometer to be sure (see Safe Minimum Cooking Temperatures Chart). Keep cooked meats hot at 140 °F or warmer until serving time — set them to the side of the grill rack to keep them hot.
• When removing foods from the grill, place them on a clean platter.
• Never use the same platter and utensils for cooked food that you used for raw meat, poultry, or seafood.

Time and temperature

Don’t let hot or cold food sit in the “Danger Zone” (between 40 °F and 140 °F) for more than 2 hours – or 1 hour if the outdoor temperature is above 90 °F. If they do, throw them away.

Learn more:

https://www.fda.gov/food/buy-store-serve-safe-food/handling-food-safely-while-eating-outdoors

https://www.fda.gov/consumers/consumer-updates/barbecue-basics-tips-prevent-foodborne-illness

To Do List from the CDC:

— Visit parks that are close to your home

Traveling long distances to visit a park may contribute to the spread of COVID-19, as:

• Travel may require you to stop along the way or be in close contact with others with whom you may not otherwise have contact.
• Travel may also expose you to surfaces contaminated with SARS-CoV-2, the virus that causes COVID-19.

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— Check with the park or recreation area in advance to prepare safely.

The federal or state and local authorities will decide whether parks and other recreational facilities will open. Check with the park in advance to be sure you know which areas or services are open, such as visitors’ centers, bathroom facilities, and concessions, and bring what you need with you, such as hand sanitizer or other supplies to maintain proper hygiene.

— Beaches or other swimming areas: State and local authorities will decide whether swim areas at oceans, lakes, and other natural bodies of water will be open. Please check with individual beaches for specific details, including whether the water is open for swimming.

— Stay at least 6 feet away from people you don’t live with (social distancing), and take other steps to prevent COVID-19 spread.

— When visiting parks, beaches, or recreational facilities open for public use, try to protect against exposure to SARS-CoV-2, the virus that causes COVID-19, by practicing social distancing and everyday steps such as washing hands often and covering coughs and sneezes.

— Follow these actions when visiting a park, beach, or recreational facility:

• Do not go into a crowded area.
• Avoid gathering with people you don’t live with.
• Wear a cloth face covering as feasible. Face coverings are most essential in times when social distancing is difficult. Cloth face coverings should not be placed on young children under age 2, anyone who has trouble breathing, or is unconscious, can’t move, or otherwise unable to remove the mask without assistance.
• Wash hands often with soap and water for at least 20 seconds, especially after going to the bathroom, before eating, and after blowing your nose, coughing, or sneezing.
• Adults and older children who can safely use hand sanitizer: Use hand sanitizer that contains at least 60% alcohol and rub hands together until dry, if soap and water are not readily available.

— Carefully consider use of playgrounds, and help children follow guidelines.

In communities where there is ongoing spread of COVID-19, playgrounds can be hard to keep safe because:

• They are often crowded and could make social distancing difficult;
• It can be difficult to keep surfaces clean and disinfected;
• SARS-CoV-2, the virus that causes COVID-19, can spread when young children touch contaminated objects, and then touch their eyes, nose, or mouth.

If you choose to visit a playground:

• Maintain a distance of at least 6 feet away from people you don’t live with.
• Wash hands with soap and water for at least 20 seconds.
  • Adults and older children who can safely use hand sanitizer: Use hand sanitizer that contains at least 60% alcohol and rub hands together until dry, if soap and water are not readily available.

— Play it safe around and in swimming pools, hot tubs, and water playgrounds, and keep space between yourself and others. Evidence suggests that COVID-19 cannot be spread to humans through most recreational water. Additionally, proper operation of these aquatic venues and disinfection of the water (with chlorine or bromine) should inactivate SARS-CoV-2, the virus that causes COVID-19.

Swimming and other water-related activities are excellent ways to get the physical activity needed for a healthy life. Taking steps to reduce the spread of COVID-19 is one way you can play it safe in and around swimming pools, hot tubs, and water playgrounds. Don’t visit a swimming pool if you are sick with, tested positive for, or were recently exposed to COVID-19. Practice social distancing by staying at least 6 feet (two meters) from people you don’t live with. Swimming does carry some health and safety risks. Visit CDC’s Healthy Swimming website for information to help you prevent illness and drowning, so you can safely enjoy the fun and health benefits of swimming.

The Don’t List from the CDC

Don’t: Visit parks if you are sick with, tested positive for COVID-19, or were recently (within 14 days) exposed to COVID-19.

• If you are sick with or tested positive for COVID-19, were recently exposed (within 14 days) to someone with COVID-19, or just don’t feel well, do not visit public areas including parks or recreational facilities.
• Follow recommended steps to take if you are sick.

Don’t: Visit crowded parks

• Do not visit parks where you cannot stay at least 6 feet away from people you don’t live with.

The U.S. Food and Drug Administration has been assuring the American public that there is no nationwide shortage of food, that local outages of certain products are the result of unprecedented demand during the COVID-19 pandemic.

At the same time, there are reports of food plants closing because of illnesses and farmers dumping milk and plowing under crops because their customers, including restaurants and schools, have been closed by social distancing mandates. Will these actions lead to food shortages?

And the FDA has been assuring the American public that the food supply is safe. At the same time, routine surveillance inspections of farms and food facilities have been postponed. So, how does the agency know that food is safe?

Frank Yiannas, FDA’s deputy commissioner for food policy and response, answers these and other questions about the state of the U.S. food supply, both now and beyond this public health crisis.

Q: I’m still seeing empty store shelves more than a month after the pandemic started changing our lives. How can you say there are no shortages?

A. I understand the concerns because I’ve seen the same thing when I go to my local grocery store with foods like flour, pasta and some canned goods. These shortages are temporary because of unprecedented consumer demand, not a lack of the food system’s ability to produce, process and deliver food. The same thing happened with pet food and, in some cases, food for livestock.

The typical grocery store today can carry over 50,000 different food products.  And while there are reported outages in some stores of select products, the reality is that most of the food items you typically find in a grocery store remain there.

The retail supply chain remains strong. For those products that have been out of stock, manufacturers and retailers of both human and animal foods are working around the clock to replenish shelves. And we are working closely with the food industry to monitor for disruptions in the supply chain that could cause shortages and to work on solutions to help avoid that.

I know these are uncertain times. But we continue to advise consumers that there is no need to buy more food than you need for a week or two for your family and pets and to leave some for others.

Q: With meat processing plants closing down, what does this mean for food safety? Are foods that have entered the market from those plants safe?

A. I want to reassure you that the U.S. food supply remains safe for both people and animals. There is NO evidence of food or food packaging being associated with transmission of COVID-19.  The virus that causes COVID-19 causes respiratory illnesses and is much more likely to be spread through person-to-person transmission.

I am aware that some processing plants closed when employees tested positive for COVID-19. However, because of the way the virus is transmitted, we do not anticipate that food products would need to be recalled or be withdrawn from the market if a person who works on a farm or in a food facility tests positive for COVID-19.

Q: With the plant closures and farmers plowing under their crops, are there food shortages on the horizon?

A. The U.S. Department of Agriculture and FDA are working closely with federal partners and the food industry to monitor the supply for nation-wide and regional shortages, which we are not seeing now. It is important to remember that food production and manufacturing are widely dispersed throughout the United States.  If one facility closes, there are other facilities that manufacture the same type of product that can help fill the demand.

There has been a lot of wasted food because the pandemic has temporarily, but significantly, disrupted the marketplace. Restaurants, hotels, schools and other entities that purchased food from farms and facilities have had to close their dining facilities. The reports of milk being dumped, and fields being plowed over are due to this imbalance in the food supply chain.  Farmers and manufacturers are working to change their normal distribution channels to redirect foods that would normally be destined for use at restaurants and other retail operations for sale within grocery stores.

While many are watching and thinking about food plant closures in terms of human food, we recognize that many of them also produce by-products that enter the animal food supply chain.  We are closely following these situations to monitor the impacts on animal food, too.

Q: What is FDA doing to help divert this excess food directly to consumers?

A. There is plenty of food; it’s just not in all the right places based on disruptions to supply chains and markets. For example, flour that is in short supply in five-pound bags at the grocery store may be available to restaurants and bakeries in 50-pound bags. We are having conversations now with federal partners and industry stakeholders, including food banks, to do all that we can to help ensure that safe and available food doesn’t go to waste.

Further, FDA has taken steps to provide flexibility with packaging and labeling requirements in an effort to reduce food waste in these difficult times. We have released guidance documents to help clear the path to the retail market for certain foods. These include providing restaurants and food manufacturers with flexibility regarding nutrition and menu labeling, as well as paving the way for shell eggs that would normally go to restaurants or for further processing to be sold directly to consumers by retail outlets.

In some cases, it may be possible to use excess foods to feed animals. FDA’s Center for Veterinary Medicine (CVM) has posted a guide for safely distributing unused human food for use in animal food.

I am grateful for all that the food industry is doing to supply safe and available food at this time. Having worked at the world’s largest retailer before coming to FDA, I know that our country’s food system is the best in the world.

Q: Turning to the larger issue of food safety, how do you know our food is safe if FDA and the states are not doing inspections of farms and food facilities?

A. Our food safety net remains strong. For the time being, we are not doing in-person routine surveillance inspections of farms and food facilities in this country and others that export foods to the United States. We are doing this to limit exposure to the virus and out of concern for the safety of FDA investigators, state inspectors, and the workers in these farms and facilities as people all over the world are sheltering in place.

However, we are still doing mission critical inspections when needed to protect public health. Such inspections could be necessitated by natural disasters, outbreaks of foodborne illness, Class 1 recalls and, in some cases, inspections at firms with a poor track record when it comes to food safety.

We have other tools and authorities to help ensure the safety of imported foods, including product examinations at the ports of entry and the use of PREDICT, our risk-based import screening tool to focus our examinations and sample collections.

And the FDA is conducting a limited number of remote inspections involving the electronic submission of records by importers covered by the Foreign Supplier Verification Programs (FSVP) requirements. We are prioritizing importers of food from foreign suppliers whose onsite food facility or farm inspections have been postponed due to COVID-19.

And last but not least, remember that FDA’s Food Safety Modernization Act (FSMA) changed the paradigm on food safety from detection to prevention.  FDA-regulated facilities are required to have preventive controls in place each and every day to ensure that the foods they produce are safe.  Industry has the primary responsibility to ensure the foods they produce are safe and by and large, they’re doing an amazing job at providing safe and available food to consumers.  Clearly, at this critical time, food safety is as important as it has ever been, and we expect food producers to redouble their food safety efforts.

Q: Are you still on the lookout for outbreaks of foodborne illness?

A. Absolutely. FDA’s Coordinated Outbreak Response and Evaluation (CORE) Network is fully staffed and on the job looking for signs of foodborne illness outbreaks. CORE works with the Centers for Disease Control and Prevention (CDC) and other partners in local, state and federal government to protect consumers from contaminated foods.

Our Center for Veterinary Medicine is also fully staffed to respond to complaints and incidents of foodborne illness in animals.

Q: What about the FDA Food Safety Modernization Act (FSMA)? Are you still implementing that considering all the other demands on FDA’s time and resources?

A. Most of the compliance dates have arrived for the major FSMA rules that put science and risk-based controls in place for the growing, production, packing, holding, transporting and importing of the foods that American consumers serve their families and feed their animals. Some inspections are temporarily on hold, but the food industry is still required to meet these requirements – that has not changed. There are other provisions we’re still working on to make them as effective as possible, such as the agricultural water quality and testing standards, and those efforts continue.

Again, I am so grateful that Congress passed FSMA because when it became law in 2011 it shifted FDA’s focus from reacting to foodborne illness outbreaks to putting safeguards in place that help prevent them. These protections are in place each and every day no matter what else is going on in the world.

Q: Before the pandemic, FDA was talking about a New Era of Smarter Food Safety. We were expecting a blueprint to have come out by now. Where does that stand?

A. We had planned to publish the New Era of Smarter Food Safety blueprint in March but had to shift our efforts to pandemic response. Just to backtrack a bit, the New Era is an initiative that FDA announced last year designed to create a more digital, traceable and safer food system. We want to leverage new technologies, analytical tools and approaches to keep foods safe in the midst of what I believe is a food revolution. Foods are being reformulated, new foods and new food production methods are being realized, and the food system is becoming increasingly digitized.

We have been working behind the scenes on the framework that will support this work going forward and will publish the blueprint when the time is right. But the issues and challenges we’ve seen in our pandemic response has shown me how timely this work is and how valuable it will be in the future.

For example, part of the New Era work involves dealing with the reality of e-commerce as more and more consumers order foods online that are delivered right to their door. We have been considering what steps we need to take to ensure the safety of those foods in how they are produced, packaged and transported. When we first started talking about this, we were anticipating that 20 percent of groceries would be ordered online by 2023. That benchmark may have been blown out of the water by consumers sheltering in place. I don’t see that trend reversing when the crisis has passed.

Another core element of the New Era plan is to foster and support food safety cultures on farms and in food facilities. We do not believe we will make dramatic improvements in reducing the burden of foodborne disease without addressing how employees think about food safety and how they demonstrate a commitment to this goal in how they do their job.

It’s clear to me that a food safety culture is also one that protects the employees from risks associated with workers who are sick, regardless of the type of virus or bacteria, and supports the maintenance of clean and sanitized facilities.

Q: Are there any lessons learned that will inform FDA’s work in the years to come?

A. Yes. I think health and safety are going to be even more important in the “new normal” that follows the pandemic. One aspect of this is that consumers are increasingly going to want to know more about their food – where it was grown or produced and what measures have been taken to ensure that it is safe for them to eat.

I also think some of the challenges we have been facing show the importance of having a dynamic, inter-operable, smarter food system that allows foods to be used when and where they are needed.

As part of our New Era of Smarter Food safety initiative, we want to enable a more digital, traceable food system.  This type of food system will increase transparency and resiliency. For example, it could help us anticipate and prepare us to address the kind of supply-chain imbalances that we are seeing now.

This experience has also reinforced something I already knew – how important it is for government to work with the private sector. In speeches I usually end by saying that my years in the private sector taught me what industry can do to keep food safe. And my time at FDA has shown me how much government can do. But what is crystal clear to me, I’d conclude, is that we can do so much more together. The truth of that statement has really been brought home because we cannot get through a crisis of this magnitude without effective public-private partnerships.

Q: What do you want consumers to know about food safety in the long term?

A. We will get through this together and will be better, stronger, and more resilient than ever.

About the deputy commissioner: Frank Yiannas is the deputy commissioner for food policy and response at the U.S. Food and Drug Administration, a position he assumed in December of 2018. He is the principal advisor to the FDA commissioner in the development and execution of policies related to food safety, including implementation of the landmark FDA Food Safety Modernization Act (FSMA). His responsibilities include food safety priorities such as outbreak response, traceback investigations, product recall activities, and supply chain innovation. Before joining the FDA, Yiannas was vice president of food safety at Walmart. Yiannas is a past president of the International Association for Food Protection (IAFP) and recipient of the 2007 NSF Lifetime Achievement Award for Leadership in Food Safety. He is also the recipient of the Collaboration Award by FDA in 2008 and he was named the 2015 Industry Professional Food Safety Hero Award by STOP Foodborne Illness, a consumer advocacy group.

Yiannas also is a past vice-chairman of the Global Food Safety Initiative. He is an adjunct professor in the Food Safety Program at Michigan State University. In 2017 he received the university’s Outstanding Faculty Award. A microbiologist, Yiannas received a bachelor’s degree in microbiology from the University of Central Florida and a Master of Public Health degree from the University of South Florida.

After a series of large-scale food safety problems almost a decade ago, Congress passed the U.S. Food and Drug Administration Food Safety Modernization Act, or FSMA, to shift our food safety system from one that focused primarily on responding to problems to a system that prevents them from happening in the first place. It was the most significant change to the food safety framework in decades and was an important step that gave the FDA new authorities to help fulfill our obligation to protect consumers. And now, as we embark on a New Era of Smarter Food Safety, we know further enhancing compliance with the foundational FSMA requirements will be critical to our success.

As the seven foundational rules of FSMA reach their compliance dates over the next several years, it’s important to begin to track their impact on the food safety system. To help us measure progress and continue to refine our implementation, the FDA has established a dashboard where we will publish metrics relating to implementation of the law.

The new Food Safety Dashboard launched today is part of FDA-TRACK, which is one tool the FDA uses to monitor certain FDA programs through key performance measures and projects, and regularly updates to ensure transparency to the public.

While we expect that it will take several years to establish trends in the data, the initial data show that since 2016, the majority of companies inspected are in compliance with the new requirements of the preventive control rules. Additional FDA data also show that overall, industry has improved the time it takes to move from identifying a recall event to initiating a voluntary recall, from an average of four days in 2016 to approximately two days in 2019. In fact, comparing the FSMA data with our recall data shows the bigger picture, demonstrating the effectiveness of preventive measures as food recalls once again have reached a five-year low.

At this point we cannot definitively say these are meaningful trends representative of the entire food industry. However, this is an encouraging start as industry, the FDA and our regulatory partners work together to improve food safety and protect consumers.

The new dashboard introduces metrics for food safety outcomes, associated measures and initial data for certain aspects of FSMA. Over time, the Food Safety Dashboard will be populated with additional data to show more FSMA outcomes and, we hope, an overall reduction in foodborne illnesses attributable to FDA-regulated food products. The initial metrics are tracking outcomes in the areas of inspections and recalls for three FSMA rules. They include:

• Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls rules for both human food and food for animals (preventive controls rules). The first compliance dates for these rules occurred in September 2016
• Imported food safety, including data relevant to the Foreign Supplier Verification Program (FSVP) rule. The first compliance date for importers subject to FSVP occurred in May 2017.

The data released today only provide a snapshot of both domestic and foreign industry compliance with these regulations.

Many factors will influence these data over time, especially in the early phases of implementation. For instance, some of the rules feature staggered compliance dates based on size of business to allow smaller businesses more time to comply. The data will ultimately help the agency identify trends in food safety, continue to improve our risk-based food safety framework, and modernize the agency’s food safety approaches in a way that will help prepare us for a New Era of Smarter Food Safety.

Publishing these metrics today is part of our commitment to greater transparency and accountability for all stakeholders responsible for improving the safety of the food supply. We plan to update the data for these three FSMA rules quarterly, with our goal being to ultimately publish metrics for all seven rules.

We know that we can’t stop every outbreak of foodborne illness; however, reducing the incidence of illness and death attributed to contaminated food is a shared goal of growers, manufacturers, packers, suppliers, importers and regulators alike. This goal can be realized through the successful implementation of FSMA and modernizing our approaches to food safety from farm to fork.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Editor’s note: FDA Acting Commissioner of Food and Drugs Ned Sharpless and Deputy Commissioner for Food Policy and Response Frank Yiannas wrote this joint statement.

Editor’s note: Three top Food and Drug Administration officials joined to write this FDA Voices blog, which was originally posted by the agency on Feb. 7, 2019. 

When the FDA Food Safety Modernization Act (FSMA) was signed into law in 2011, one of the most challenging parts of Congress’ mandate was to transform the nation’s food safety system as it related to produce safety and implement a system of preventive controls that aimed to avert problems. At that time, U.S. produce farmers, and those in countries that export to the United States, had never been subject to this level of federal food safety oversight and, quite frankly, we at FDA had a lot to learn about the unique challenges farmers face every day. The idea of implementing preventive measures to head off food safety problems was a new and modern approach to regulation that promised to bring significant benefits for consumers.

The produce farming community is diverse, as are farming practices across our country and around the world. And, importantly, in the majority of cases, the farms are people’s homes. Knowing these challenges, FDA has invested many hours and resources, in partnership with the states, to pave a smooth path as we prepare for routine inspections. We’re pleased to affirm that routine inspections of the largest domestic and international farms, other than sprouts operations, will begin this spring.

Fresh produce is an important part of an overall healthy diet. The vast majority of fresh produce we eat is generally safe, especially when you consider per capita consumption rates. Unfortunately, in too many cases, foodborne illnesses are still being linked to fresh produce.

The Produce Safety Rule established under FSMA sets, for the first time, science-based standards for the safe growing, harvesting, packing and holding, of fruits and vegetables. In crafting this rule, and its series of preventive controls, we undertook an unprecedented amount of outreach, visiting farms and regulatory partners all over the world to get feedback and insights on the most effective and feasible ways to prevent produce contamination.

Even so, when the time came a year ago to begin routine inspections of large farms, other than sprouts operations (which have requirements specific to them), for compliance with the rule, we heard — and agreed — that more time was needed to ensure that produce farmers have the training and information they need to help them comply with the new requirements. We also wanted to give the states more time to establish strong produce regulatory programs. After all, states will be doing most of the routine inspections.

To achieve these goals, we postponed these large-farm inspections until the spring of 2019, except for certain potentially high-risk situations, such as ongoing outbreak investigations. We also determined that routine inspections of small farms, other than sprouts operations, subject to the Produce Safety Rule should not begin until Spring 2020. Their first major compliance date — January 28, 2019 – arrived a year after the corresponding compliance deadline for large farms.

With a few months to go before routine inspections begin for these large farms in the spring of 2019, we’d like to take this opportunity to let you know what we’ve been doing to support stakeholders’ work to comply with this rule and fulfill our promise to address some remaining needs before initiating the inspections. We’ve continued an intense effort to provide more resources to everyone involved in making these new standards a reality, including farms of all sizes, state and federal regulators, and cooperative extension agents.

Helping the states
FDA has granted 46 states and one territory more than $85 million through the State Produce Implementation Cooperative Agreement Program (CAP). These funds are being used to develop state produce safety systems that will provide education, outreach and technical assistance to meet the unique needs of their produce farming communities.

Most states opted to also use this funding to conduct produce farm inspections. A key goal for FDA’s CAP program is creating an inspectional system in which the state experts who are most familiar with local farming practices conduct the bulk of inspections. FDA will also be doing inspections. But our resources will be focused on inspections in states that didn’t sign up for the CAP inspections, conducting foreign produce inspections, and working with state partners in certain “for cause” inspections, like those conducted during an outbreak investigation.

Providing training
With our support, the Produce Safety Alliance and the Produce International Partnership for Education and Outreach, have led efforts to train more than 31,000 produce farmers around the world on the requirements of the Produce Safety Rule. We’ll continue to provide training to FDA staff and state partners who perform produce farm inspections. We’ve also provided training for state cooperative extension agents who are recognized by the farming community as a source for valuable information and resources for farms in their regions.

Issuing guidance
Last October, we published the draft compliance and implementation guidance for the Produce Safety Rule, along with fact sheets highlighting key information in each chapter. When finalized, the draft guidance will provide FDA’s recommendations to help produce farmers understand how to develop their own food safety practices that comply with the Produce Safety Rule. We have conducted four public meetings to discuss the draft guidance with stakeholders. These resources are available at fda.gov.

Sharing expertise
Our Produce Safety Network staff continues to work with states and other stakeholders to implement our national produce regulatory system.

Located throughout the country, these produce safety experts and specialized investigators provide localized regulatory and technical assistance. Basing produce safety staff in specific growing regions allows them to develop a deep understanding of and expertise in the growing practices and conditions unique to their area and the produce grown there.

Reviewing readiness
The National Association of State Departments of Agriculture (NASDA), with FDA participation, has developed and implemented the On-Farm Readiness Review (OFRR) program. These voluntary reviews are designed to help produce farmers determine how prepared they are to comply with the Produce Safety Rule and to provide specific recommendations for improving their operation and implementing good practices. More than 350 farms have had this evaluation thus far. These reviews will continue to be available even as inspections begin.

Creating specialized inspectional forms and procedures
FDA, NASDA, and our state partners, have collaborated to develop a new inspection form to provide feedback to farms and document observations. This form — called FDA 4056/Produce Farm Inspection Observations — was designed around the specific provisions in the Produce Safety Rule. As produce inspections begin, we’ll pilot this as an alternative to our traditional inspectional form – FDA 483, used in inspections of food manufacturing facilities.

Farms are different and require a different approach. This form has been made available to our state partners for their use in produce regulatory programs. FDA will issue the new form at the end of every farm inspection, whether or not any non-compliance issues were identified, to explain what’s being examined and how any observation relates to the regulation.

Additionally, we’ve created a fact sheet with NASDA outlining for stakeholders what they can expect from a regulatory inspection. This resource is provided to produce farmers and other stakeholders to help clarify the steps/processes for what will happen before, during, and after an inspection. Produce farmers may not have experienced a food safety regulatory inspection before. These resources are designed to help farmers meet our shared goals and standards.

For more information about, and links to, these resources, we’ve created a new Produce Inspections web page at fda.gov. This page serves as a central location for our stakeholders and state partners to find resources as they make their final preparations for the start of routine inspections this spring. The importance of our efforts to achieve high rates of compliance with the new produce standards is underscored by the outbreaks of foodborne illness we’ve seen recently in fresh produce. We understand the important role fresh produce plays in an overall healthy diet. To advance these goals, we want to further strengthen the safeguards and the confidence that consumers have in these products, which are vital to our well-being. We’ll continue to educate while we regulate and look for knowledge gaps. And we’ll provide resources necessary to help stakeholders in the produce industry protect the public from foodborne illnesses.

About the authors: Scott Gottlieb is commissioner of the U.S. Food and Drug Administration; Frank Yiannas is FDA’s deputy commissioner for food policy and response; Melinda Plaisier is FDA’s associate commissioner of regulatory affairs.

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Editor’s note: This consumer advice column, by FDA staff working with the Center for Food Safety and Applied Nutrition, was originally published on www.foodsafety.gov. Please remember, some premixed eggnog products sold in retailers’ refrigerated and frozen food departments are not made with pasteurized eggs and, like homemade eggnog, have been linked to illnesses. Raw milk also poses serious health risks because it has not been pasteurized to kill pathogens, bacteria and viruses.

Homemade eggnog is a tradition in many families during the holiday season. But each year this creamy drink causes many cases of Salmonella. The ingredient responsible? Usually raw or undercooked eggs.

Eggs are a standard ingredient in most homemade eggnog recipes, giving the beverage its characteristic frothy texture. To prevent this ingredient from causing harmful infections, just follow these guidelines for safe handling.

Cooking the egg base
At the FDA, we advise consumers to start with a cooked egg base for eggnog. This is especially important if you are serving people at high risk for foodborne infections: young children and pregnant women (non-alcoholic eggnog), older adults, and those with weakened immune systems.

To make a cooked egg base:

1. Combine eggs and half the milk as indicated in the recipe. Other ingredients, such as sugar may be added at this step.
2. Cook the mixture gently to an internal temperature of 160 degrees F, stirring constantly. The cooking will destroy Salmonella, if present.
3. After cooking, chill the mixture before adding the rest of the milk and other ingredients.

Don’t count on alcohol to kill bacteria
Some people think that adding rum, whiskey, or other alcohol to the recipe will make the eggnog safe. But, if contaminated unpasteurized eggs are used in eggnog, you can’t count on the alcohol in the drink to kill all of the bacteria – that’s not likely to happen

Other options for safe eggnog
You can also use egg substitute products or pasteurized eggs in your eggnog, or you can find a recipe without eggs.

• With the egg substitute products, you might have to experiment a bit with the recipe to figure out the right amount to add for the best flavor.

• Pasteurized eggs can also be used in place of raw eggs. Commercial pasteurization of eggs is a heat process at low temperatures that destroys Salmonella that might be present, without having a noticeable effect on flavor or nutritional content. These are available at some supermarkets for a slightly higher cost than unpasteurized eggs. Even if you’re using pasteurized eggs for your eggnog, both the FDA and the USDA recommend starting with a cooked egg base for optimal safety.

So, by following these safe handling and proper cooking practices, you can enjoy delicious, creamy homemade eggnog without worrying about making anyone sick!

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Your soon-to-be 6-year-old wants you to bake elaborately decorated holiday cookies and cakes in the shapes of of the season. You’ve found a cake-decoration video online, but it uses ingredients that make you wonder if they are safe to eat.

The food and Drug Administration wants you to be aware that some decorative glitters and dusts promoted for use on foods may, in fact, contain materials that should not be eaten. Non-toxic does not mean edible, so if you’re not sure about a product, select something else.

Many decorative glitters and dusts are sold over the internet and in craft and bakery supply stores under names such as luster dust, disco dust, twinkle dust, sparkle dust, highlighter, shimmer powder, pearl dust, and petal dust. Moreover, a variety of online instructional videos, blogs, and articles promote the use of these glitters and dusts to decorate foods such as cakes, cupcakes, and cake pops.

To view an FDA video about food decorations that should not be eaten, please click here.

There are some glitters and dusts that are edible and produced specifically for use on foods. These products are made from ingredients that are safe to eat. But others may not.

Edible or Non-Edible
There are easy things you can do to determine what’s edible and what’s non-edible:

• Carefully check the label of any decorative product you’re considering for use in foods. Companies that make edible glitters and dusts are required by law to include a list of ingredients on the label.
• Common ingredients in edible glitter or dust include sugar, acacia (gum arabic), maltodextrin, cornstarch, and color additives specifically approved for food use, including mica-based pearlescent pigments and FD&C colors such as FD&C Blue No. 1.
• Most edible glitters and dusts also state “edible” on the label. If the label simply says “non-toxic” or “for decorative purposes only” and does not include an ingredients list, you should not use the product directly on foods.
• If you choose to decorate a food item with decorations that are not edible, be sure to remove the decorations before serving and eating the food.

Buying, not baking? Talk to your baker
Talk to your bakery about the types of decorative products they use in their baked goods. Are they made with all edible ingredients?

When in doubt, ask to see the labels of the decorative products to ensure they are edible. And be informed about the glitter and dust products sold on the Internet. Ask the seller to provide ingredient information from the manufacturer before you buy.

A Note to Commercial Bakers
FDA reminds all commercial bakers that it is your responsibility as a food manufacturer to produce food that complies with the Federal Food, Drug and Cosmetic Act and applicable FDA regulations. Manufacturers of food containing unsafe ingredients are potentially subject to FDA enforcement actions to keep unsafe products out of the marketplace.

If you have specific questions about the regulatory status of ingredients in glitter and dust used in food decorating, contact the Office of Food Additive Safety at [email protected].

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My name is Scott Loughan and I am a Compliance Officer in the Food and Drug Administration’s Office of Regulatory Affairs. I work in Vermont and I am a senior case officer in my division. It’s my job to protect the public health by working with manufacturers that FDA regulates to make sure they meet all federal laws, rules, and regulations.

To do this I review and evaluate findings and evidence collected during inspections by our FDA investigators that could indicate a possible lack of compliance with agency enforced laws, and regulations.

I also work with manufacturers to try to get them to voluntarily comply with FDA regulations. If they don’t, it’s my job to use other methods such as Warning and/or Advisory Letters, Informal Agency Hearings, and Administrative Actions to make sure they follow the rules.

When these methods don’t work I determine the most suitable public health course of action. When necessary I recommend administrative or legal actions and I work with ORA’s (Office of Regulatory Affairs) headquarters, the FDA’s Office of the Chief Counsel, and the responsible U.S. Attorney’s Office to ensure compliance. FDA may recall or detain products, which we call administrative detention, and when necessary take court actions including seizures or injunctions, to make sure that unsafe products do not reach consumers.

Since I joined FDA in 2002, I have worked on many cases. One case that I’m especially proud of is a judicial seizure that removed over 5,000 cases of ready-to-eat frozen cooked crabmeat from the marketplace in October 2015. We determined that the products had been prepared, packed and held under unsanitary conditions, which could have presented a risk to consumers.

I coordinated multiple FDA inspection teams to develop evidence to support the seizure and worked with the U.S. Attorney’s Office in Boston to present the case in U.S. District Court. Once the courts ruled in our favor, working with the U.S. Marshal Service we seized and destroyed the product to protect the public from potentially serious or deadly foodborne illness. Our New England team is very proud of this effort.

The work I do is important and focused on public health protection. I feel that I make a difference every day that I go to work helping to protect the food that we eat. I’m constantly learning something new and that keeps the work interesting and dynamic.

I have always been thankful for the day an FDA investigator who was conducting an inspection of a pharmaceutical plant where I worked took me aside and told me that he thought I should consider doing something really meaningful. He encouraged me to apply for an opening that FDA had posted on USA Jobs.

That evening I went online and applied for an FDA Import investigator position. The attacks of 9/11 had recently occurred and a short time later I was offered a position under the counterterrorism new hire initiative. The FDA investigator who encouraged me to apply for the job later became an ORA supervisor and then a compliance officer. We remain friends to this day.

I am very honored to be this year’s ORA Compliance Officer of the Year.

I am Scott Loughan and #IAmORA.

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Editor’s note: The FDA’s Commissioner Scott Gottlieb and Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff combined efforts for this column. 

We know how important it is to get produce safety right. Taking steps to prevent contamination of produce is the primary purpose of the Food Safety Modernization Act’s (FSMA) Produce Safety Rule. The FDA is committed to making sure that the standards designed to minimize the risk of contamination are workable, and that farmers have the information and tools needed to effectively implement them.

One of the resources now available to farmers is the On-Farm Readiness Review (OFRR) program. The National Association of State Departments of Agriculture (NASDA)created this program in collaboration with the FDA. On-Farm Readiness Reviews provide farmers real-time feedback on their current operations and facilities. These reviews can help farmers address any areas in need of improvement before a regulatory inspection takes place in the future. Working together, the aim is to improve the safety of the food supply while still maintaining a vibrant agriculture sector.

As part of this program for advance, readiness reviews, food safety professionals conduct voluntary, non-regulatory visits to farms and packinghouses. Their goal is to observe current practices and provide feedback on how those practices can be strengthened to better align with regulatory expectations. These reviews are not inspections. There are no written reports or paperwork associated with these visits.

Many states are using the cooperative agreement funds that they received from the FDA to support the program. When the FDA announced that regulatory inspections would be delayed until next year, we encouraged our state partners to redirect some of the funds they had initially planned for inspections to these activities. We have spent much time visiting with farmers and collaborating with them on a shared mission of food safety. We know that the farming community wants to be in compliance with food safety laws. Together, we see great value in helping farms strengthen their practices. The idea is to take steps now to make sure all farmers are ready for the implementation of FSMA’s inspections.

While market-driven, on-farm audits may not be new to produce farmers, FSMA-mandated inspections will be new. The readiness reviews give farmers an opportunity to get individualized feedback from food safety professionals before inspections begin next year. We visited farms on opposite coasts this summer to observe reviews and talk to farmers directly about the progress they’ve made and the challenges they foresee.

And the FDA is committed to continuing to work with farmers to address remaining issues.

On this trip, Alexis Taylor, the director of the Oregon Department of Agriculture; Bob Ehart, the NASDA senior policy and science advisor; and several other local farmers, accompanied us. Our FDA team included colleagues from FDA’s Produce Safety Network, who are regionally stationed around the country. These FDA colleagues are a tremendous asset to support the states, farmers, and other stakeholders in understanding and implementing the Produce Safety Rule.

The team began the review by explaining the OFRR process and walking through which parts of the Produce Safety Rule were relevant for farmer Gary Willis’ operations. They also discussed his established recordkeeping practices and the trainings he has already completed, both of which are helpful in meeting rule requirements. The tour of the farm had the feel of a guided conversation to better understand practices Mr. Willis has in place for equipment and facility maintenance, worker health and safety, and maintaining restroom and hand washing facilities. We also learned about the farm’s harvesting methods and irrigation system. This time spent with Mr. Willis was invaluable, and his commitment to food safety was clear. We are grateful for his invitation to us to join the visit. By the end of the review, Mr. Willis and his fellow farmers had a better understanding of what to expect during an inspection as well as a firmer grasp of how to meet the Produce Safety Rule requirements.

A second visit was to the Jackson Farming Company in North Carolina. This visit gave us another opportunity to personally see the value of these reviews. Here the OFRR focused on worker hygiene and training, along with food packing and storage. The North Carolina Department of Agriculture and Consumer Services, NASDA, North Carolina State University, and the North Carolina Farm Bureau organized this OFRR tour. We were joined by North Carolina Agriculture Commissioner Steve Troxler to meet farm owner Brent Jackson, his son Rodney, and his food safety team.

At the farm, we observed the steps they’re taking to ensure workers are properly trained on their jobs, and don’t contaminate produce; steps to identify workers who are sick and shouldn’t be around produce; the access to hand washing and bathroom facilities; and when gloves, aprons and other barrier protections are used.  We also walked through the packing operation as the season’s last cantaloupes came in from the field and saw how they were unloaded, cleaned, sorted, packed, cooled and stored.

Throughout this visit, we saw firsthand the benefit of the continuous dialogue, interaction and information sharing between the OFRR team and farm staff. Both parties were fully engaged in talking through the requirements and determining whether the farm appears to be meeting the standards or how processes can be improved to ensure they’re met. The fact that farm staff had been through the Produce Safety Alliance training before our visit helped them understand the process of the review and major components of the FSMA rule. It made for an efficient and effective visit.

Our time spent with these family farmers only deepened our appreciation for the hardworking American farming community, and affirmed the value of state, NASDA, and FDA efforts to make the OFRR program and other training and technical assistance available. During the final day of the visit to North Carolina, the FDA also had the opportunity to participate in Agriculture Commissioner Troxler’s 14th annual Food Safety Symposium. More than 300 people from around the state attended this gathering. The event focused on the Produce Safety Rule. It provided a valuable educational opportunity for the state’s farming community. It was encouraging to see so many North Carolinians at the event and such significant interest and enthusiasm throughout the farming community regarding food safety.

It’s reassuring to see how useful OFRR visits can be in helping farmers understand what to expect in working with us to help ensure the safety of the fruits and vegetables we serve our families. We encourage farmers to take advantage of these reviews. Interested farmers should first attend a Produce Safety Alliance (PSA) training course (or equivalent). Upcoming training courses are listed on the PSA website. Once trained, farmers should contact their state Department of Agriculture (or the Department of Health in Alaska and Indiana). Farmers can also contact NASDA at [email protected] for more information.

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Editor’s note: This is part of series of articles and opinion columns we are publishing in recognition of September as Food Safety Education Month.

In an effort to enhance retail food safety, the U.S. Food and Drug Administration has released two video testimonials. Less than 10 minutes each, the videos educate retail and foodservice employees on the possible, dire consequences of poor food safety practices.

The two videos feature testimonials of people who were severely affected by foodborne illness, which is preventable. In one of the videos, a woman ate food contaminated with Salmonella from a restaurant. In the other video, a man contracted norovirus after consuming a meal at a local restaurant that was prepared by an ill employee.

The videos support the FDA’s Retail Food Safety Initiative, which seeks to strengthen the retail and foodservice industry’s active managerial control of foodborne illness risk factors. The videos were produced to enhance food safety training efforts at the retail level by helping food employees understand the important role they play in protecting public health.

In addition to the video testimonials, FDA has produced numerous food safety posters and storyboards in nine different languages: English, Spanish, Simplified Chinese, Traditional Chinese, Vietnamese, Russian, Korean, Hindi, and Arabic.

The agency encourages industry operators, food safety educators/trainers, and federal, state, local, tribal, and territorial regulatory officials to take full advantage of the materials, which are available free of charge at www.fda.gov/foodemployeetraining.

Editor’s note: To view the new videos, as well as previous videos from the FDA, please click here.

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For a different view on this topic, please see “Counterpoint: FDA traceback procedures show chokepoints.”

The FDA continues to investigate the outbreak of E. coli O157:H7 infections associated with romaine lettuce from the Yuma growing region. Any contaminated product from the Yuma growing region has already worked its way through the food supply and is no longer available for consumption. So any immediate risk is gone. However, the FDA is committed to investigating the source of the outbreak and working with industry to help prevent similar events in the future.

This is a serious and tragic outbreak. And we’re devoting considerable effort to identifying the primary source. We’ve made progress in recent weeks toward this goal. This outbreak of E. coliO157:H7 illnesses is the largest in the United States in more than 10 years. As of today, it has affected 172 persons in 32 states, and it is anticipated the numbers will be updated on Friday. Tragically, 45 percent of these ill people have been hospitalized, and one has died. And 20 of these people have developed hemolytic uremic syndrome (HUS), one of the most serious complications that can occur with E. coliO157:H7 infection.

These statistics reflect the severity of this particular foodborne illness. The kidney damage that’s associated with HUS can require temporary dialysis and the kidneys may never fully recover. For these reasons, anytime outbreaks caused by this pathogen occur, we need to find the root cause of the contamination and determine what went wrong. We need to relay these findings to industry so that measures can be put in place to prevent it from happening again.

The FDA’s investigators are actively searching for answers as to the source of this outbreak, and what steps can be taken to prevent it from recurring in future growing seasons. In the current outbreak, illness has generally been linked to the consumption of chopped romaine lettuce. The lettuce was generally consumed at restaurants or purchased at markets. In one cluster of illnesses at an Alaska correctional facility, the prison received and served whole head romaine lettuce rather than chopped and bagged romaine.

The FDA and our state partners have been involved in extensive traceback efforts of the romaine lettuce that was likely consumed by those who became ill. Traceback involves working backwards from the point of consumption or purchase of the product through the supply chain. It often includes investigating the multiple steps along the way. These steps can include suppliers, distributors and processors where the lettuce was chopped and bagged, and then back to the farm or farms that could have grown the lettuce that ended up in those bags. It’s a labor-intensive task. It requires collecting and evaluating thousands of records; and trying to accurately reproduce how the contaminated lettuce moved through the food supply chain to grocery stores, restaurants and other locations where it was sold or served to the consumers who became ill.

Our traceback efforts are designed to find points of convergence from several well identified clusters of illness with a common point of exposure, such as a restaurant or grocery store. This means that as we draw lines for each cluster from one point in the supply chain to another point, we look for places where the lines will intersect and lead back to a common location. This can then help clarify where the contamination may have taken place.

We usually do this for clusters of ill individuals that occurred in different parts of the country; since lettuce in one part of the country may not follow the same pathway as lettuce in another part of the country. When that point of convergence is identified, efforts can then focus on how the contamination occurred at that location.

We’ve conducted traceback activities for many of the illnesses identified in this outbreak. We’ve used this information to create a traceback diagram that we’re releasing today. The diagram does not include tracebacks for all 172 cases. Rather, it focuses on settings where there were several well-documented clusters of cases. As additional traceback information is received, we anticipate the diagram will be updated.

As can be seen in the diagram, in the current outbreak, and based on the information we have to date, there are still no obvious points of convergence along the supply chain. There is only one straight line back to a single farm. And that particular instance involves the whole head lettuce served in the Alaska correctional facility, since it was not processed and was not mixed with lettuce from multiple farms, as seen in other parts of the traceback.

In these other tracebacks in the diagram, there are different suppliers, distributors and/or processors. These pathways lead back to different farms, sometimes many farms, where possibly contaminated lettuce could have been harvested during the timeframe of interest. The only point of commonality in our traceback efforts to date is that all of the farms are located in the Yuma growing region. This region is where a large portion of the romaine lettuce supply in the United States comes from during the winter months.

What does this traceback diagram tell us?

It says that there isn’t a simple or obvious explanation for how this outbreak occurred within the supply chain. If the explanation was as simple as a single farm, or a single processor or distributor, we would have already figured that out. The traceback diagram does show us that the contamination with E. coli O157:H7 was unlikely to have happened near the end of the supply chain (such as at a distributor) because there are no common distributors among the places that received and sold or served contaminated lettuce. The contamination likely happened at, or close to, the Yuma growing area.

Our task now is to investigate what happened. We are actively evaluating a number of theories about how romaine lettuce grown on multiple farms in the same growing region could have become contaminated around the same time. It’s possible that contamination occurred on multiple farms at once, through some sort of environmental contamination (e.g., irrigation water, air/dust, water used for pesticide application, animal encroachment). Another possibility is that it happened just after the lettuce left the farm. We are examining all possibilities and as we investigate we learn more about a potential common source we will communicate this information with growers and consumers. But the source and mode of contamination may remain difficult to identify.

Our efforts are complicated by the fact that romaine lettuce is a perishable commodity with a short shelf life of a couple of weeks. None of the lettuce that likely made people sick was available for testing because of the time between the incubation period of E. coli O157:H7 (the time between exposure to the lettuce and the onset of illness) and the time it takes to seek health care and collect specimens from ill people, test those specimens, report the illnesses to public health officials, fingerprint the pathogen to make sure it is part of the outbreak, and interview the ill people to identify where and when they were exposed.  By that time, the lettuce they ate which could have made them ill is long gone.

Similarly, the lettuce growing and harvesting season in the Yuma growing region was essentially over by the time the outbreak was recognized in April, and harvesting has since ceased. That is why we, and our colleagues at the Centers for Disease Control and Prevention, have said that there’s no longer any romaine lettuce from the Yuma growing region available for purchase or consumption.

Romaine lettuce production in this area is now idle until later in the year. This makes it difficult to find places where the E. coli O157:H7 organism that caused the outbreak may have been hiding.

We have no evidence that romaine lettuce from other growing regions have been a part of this outbreak.

The FDA is looking at all possibilities for how the contamination may have caused such a large outbreak. This work will continue. In these efforts, we’re collaborating with outside experts who may have insights, ideas, or suggestions. This includes working with farmers, technical experts, the lettuce processing industry, state partners, and others. It also includes on-site assessments. Through such assessments we may be able to find a possible explanation so that steps can be taken to prevent this problem from recurring.

We’re committed to these efforts, and finding the root cause of this outbreak.

Romaine lettuce is one of the most popular types of lettuce in this country. We want American consumers to be confident in the quality and safety of the lettuce they consume. In addition to working to identify the source and mode of contamination, we will also continue working after the outbreak to evaluate what happened and how lessons learned can be used to provide feedback to industry on best practices and areas to work on. These include better tools to more efficiently and swiftly traceback commodities like lettuce through the supply chain, and better ways to standardize record keeping. We also want to explore the use of additional tools on product packaging that could improve traceability. For example, could QR codes be used to provide additional information that could help consumers more easily identify which lettuce should be avoided and which lettuce is ok to eat?

We’re also working with the leafy greens industry and technical experts to explore methods to grow and process lettuce in ways that further reduce the risk of outbreaks. We live in an era of unprecedented innovation and technology, and we want to bring more of that innovation and technology to bear to help solve this problem and ensure consumer confidence in healthy fruits and vegetables.

Food safety is one of the highest priorities at the FDA. This outbreak is a clear illustration of why that’s the case. It shows the terrible consequences when something goes wrong.

This outbreak marks the importance of moving forward with the Food Safety Modernization Act’s Produce Safety Rule. That rule is designed to implement practical measures to prevent contamination of fruits and vegetables at the farm. This rule is being implemented in close collaboration with our state partners and with our federal partners at the U.S. Department of Agriculture.

State partners will do the vast majority of routine inspections under the Produce Safety Rule. They are often the most familiar with their farming communities and growing and harvest practices. These inspections are slated to begin next year. We’re currently in the process of finalizing the guidance and training farmers throughout the country and those who ship produce to the U.S. on the rule’s requirements.

We believe that the measures outlined by the Produce Safety Rule, when fully implemented, will reduce the chance of an outbreak similar to the one we just experienced. That’s our goal, and our commitment, to the American public.

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Stic Harris
Courtesy of FDA

Stic Harris, DVM, MPH, has been the director of FDA’s Coordinated Outbreak Response and Evaluation Network (CORE) since August 2017. He is responsible for the agency’s surveillance, response, and post-response activities associated with outbreaks of illnesses caused by food, dietary supplements, and cosmetics.

In many ways, Harris defies the stereotype of a government official, with professional incarnations that include college athlete, professional hockey player, epidemiologist, veterinarian, congressional fellow, and biodefense expert. He came to FDA from the Department of Defense (DOD), where he had established himself as an expert in global outbreak response.

With six months at the helm of CORE, Harris shares some insights on everything from his uncommon first name to his passion for public health and what lies ahead for CORE.

Q. Stic, you have quite an interesting name. Is there a story behind it?
Stic isn’t my “real” first name. I was given the nickname while trying out for the hockey team during my freshman year at the University of Michigan. On the first day as a goaltender I was so nervous I hit everything that moved with my stick – including my own teammates. After having enough of getting hit, a larger and older teammate skated up to me and said “I don’t know what your name is, but I’m going to call you ‘stick,’ and if you hit me again I’m going to drop you.” From that day forward I had a new name.

Q: Can you tell me more about your background?
I’ve got something of a nomadic past. I started college with Michigan’s hockey team, but at the end of freshman year, I was in a very bad car accident. The doctors told me that I might not walk again, but after a summer of physical therapy, I returned to school and joined the track program.

I’ve always had a lot of different interests and they’ve shaped both my personal and professional life. As I finished my undergraduate degree, majoring in microbiology and classical archeology, I was offered a chance to play professional hockey. After three years of chasing that dream, I decided it was time to change course and pursue a different passion – public health. I studied for my master’s degree in molecular epidemiology and public health genetics.

From there I moved to Austin to work for the Texas Department of Health and then relocated to Georgia to work for the state health department there. At the state level, I worked on such issues as lead poisoning, prion diseases, arthritis, bioterrorism, maternal and child health, and cancer.

When I was 35, I changed course again, enrolling in veterinary school at the University of Georgia. I had always expected to return to medical school but over the years my feelings on what type of doctor I want to be had changed. A supervisor in Georgia planted the seed of veterinary school and I worked to make it happen. While there, I interned at USDA and the CDC, working on infectious animal diseases, foodborne diseases, and outbreaks.

After that, I moved to Washington D.C. and worked for a year as a Congressional Fellow. I didn’t know at the time that what I learned there would help lay the groundwork for my role at FDA. One of the issues I worked on was the then proposed new FDA Food Safety Modernization Act (FSMA), which you know is a major priority for FDA.

Q: You came to FDA as a biodefense expert. How did that happen?
I had worked on bioterrorism preparedness issues at the state health departments in Texas and Georgia. After finishing my year with the Senate, I joined the Department of Homeland Security’s Office of Health Affairs as a veterinary medical officer. We worked with other federal agencies on biodefense and biosecurity issues affecting human, animal, plant, and environmental health. I was there for two years before being approached by DOD’s Armed Forces Health Surveillance Center to lead its new Alert and Response Operations Team, created to monitor global disease outbreaks. Our office quickly turned into a multidisciplinary team tracking and reporting on events across the globe.

Q: What drew you to FDA and CORE?
My true passion lies in protecting public health. I was actually here (at FDA) briefing CORE on global outbreaks that DOD was monitoring and an old colleague informed me that FDA was looking for a new director for CORE. I did some investigation into CORE and the position and the more I researched and talked to people, the more it seemed like a great fit for me.

Q: How would you describe your management style?
I like a team approach, which works well here because CORE knows a thing or two about teamwork. We are divided into three main teams: Signals & Surveillance uses databases, adverse event reports to FDA, news reports, sampling information, and other sources to identify potential outbreaks. The Response team is divided into three subgroups that lead traceback investigations during an outbreak. The teams work with FDA field offices to arrange inspections, sampling, and collection of records while coordinating with other federal, state, and local agencies.

During response to outbreaks, the Response teams also work closely with compliance and enforcement staff in both CFSAN and the field offices to ensure product recalls and other regulatory actions are conducted as warranted to protect the public.  And our Post Response team incorporates lessons learned from outbreaks to prevent future outbreaks through policy advice and guidance, and through suggesting future sampling or research assignments. They also use the lessons learned to propose changes to improve the response activities.

One of the best parts about this team of teams is their interaction. The teams work together to anticipate, address, and learn from outbreaks. As outbreaks move from Signals & Surveillance to a Response team and then on to the Post Response team, team members are already aware because they’ve been involved from the start. That inclusiveness makes the transitions much more straightforward.

Q: What do you see as CORE’s greatest strength?
The people, easily. We have a tremendous group of people who continue to amaze and impress me every day with their breadth of knowledge and dedication to our mission. The staff works late nights, weekends, and holidays without giving it a second thought because everyone recognizes the importance of what we do in protecting the public’s health. I feel very privileged to work with and lead such a knowledgeable and dedicated group of people.

Q: What is the biggest challenge?
To me the biggest challenge is a personal one – my limited knowledge of FDA. While I have a lot of experience with surveillance, response, public health, and working across groups and agencies, I’ve never worked for a regulatory agency before.  There’s so much to learn and so many different considerations. So I’m working hard to drink from that fire hose and learn as much as possible so I don’t let CORE down.

Q: How do you see CORE evolving?
We’re an organization that has “coordinated” in our name. As part of that you have to continually become better at communications. We coordinate with groups within FDA and across other agencies. That gives you greater awareness of what’s going on in the world and how people think. I think we want to expand that.

Instead of relying on the common response of, “We can’t talk about that,” we need to evaluate whether and when we can share information with our partners and stakeholders. We don’t always have to do what’s always been done – we can look at other ways. Partnerships and collaboration is what is going to help everyone move forward in protecting public health.

One of the reasons I was hired is because I’ve worked a lot on bridging gaps across academia, industry, and the state and federal government; a skillset that is particularly valuable to an organization so reliant on communication. We’re all wanting the same end result – an end to foodborne outbreaks, even though we may be going about it differently. We need to build off that common ground. For us, sharing the information we learn and working collaboratively can help prevent future problems from arising.

Q: What is the greatest danger in food safety?
This answer may seem in the weeds but it’s important. FDA and CDC are both concerned about the increasing use by doctors and clinical laboratories of culture-independent diagnostic tests (CIDT) and how this will affect foodborne outbreak investigations in the future.

These tests are great since they quickly give you a simple yes or no on the presence of a pathogen without having to culture the bacteria in the lab. But without actually growing and typing the pathogen you lose out on a huge part of how we investigate outbreaks. If CDC is unable to get a sample because they don’t have the actual culture of the organism, it becomes difficult for us to use the PFGE (pulsed-field gel electrophoresis) or WGS (whole genome sequencing) in identifying related samples.

PFGE and WGS look at the DNA fingerprint left behind by a pathogen, which can be linked to the clinical samples from people. That’s going to make things much harder. Everyone focuses on how WGS will allow us to see more and identify more, but if more CIDT continues, it’s going to be a challenge that has to be overcome.

More broadly, I continue to believe the biggest danger to our food supply is the global reach of our food sources. More than half of our fruit and 80 percent of our seafood are imported. FSMA has given us tools to help in this arena, which augment the work we do with other countries on food safety, but the global scale of our food supply adds complexity.

Q: Does FSMA have an impact on your work?
Ironically, I was able to work in the FSMA landscape during its creation while I was working on Capitol Hill. I remember at that time I saw it as a creation of laws and policy that we were ironing out and negotiating. We didn’t envision how this work would affect the individual because we were focused on creating an overhaul of the entire food safety system.

Now I get to see how FSMA has played out and is being implemented by the people actually doing the work. I remember talking to the FDA liaison to the Senate in 2009 and I never considered the actual work being done by the individuals. Now it’s much more seeing how this affects people’s jobs and seeing people who are so dedicated to keeping the nation’s food supply safe and making sure people’s kids don’t get sick.

During the massive salmonella outbreak caused by contaminated (peanut butter and peanut paste products) in 2008 and 2009, I got to know a victim’s son who testified on Capitol Hill during a hearing about it. It was a really tough item to work on, but the gentleman and I are still in touch and I keep meaning to reach out to him and say, “You’re never going to believe where I am right now.”

I remember talking with him and I reached out when FSMA got passed to let him know I was thinking about his mom. I want to reach out to him again to let him know that I’m now with the FDA, leading CORE and how important it was to me to meet someone whose life was so impacted by a foodborne illness and put a face to what we were working so hard for.

Q: What do you want people to know about CORE?
I want people to know that the people of CORE are fantastic, smart, dedicated individuals. This job isn’t about me, but about protecting the public health and I can’t credit my staff enough for how hard they work to keep people safe.

The sad thing about public health is that if you do your job perfectly, no one ever knows what you did, so much of what they do is simply unnoticed. It’s an incredibly challenging job and I know they don’t get the credit they deserve for all they do.

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As part of the Food Safety Modernization Act (FSMA), the Food and Drug Administration issued on May 27, 2016, a final rule to require domestic and foreign food facilities, with some exceptions, to address hazards that may be introduced with the intention to cause wide-scale harm to public health.

These food facilities are required to identify significant vulnerabilities and take steps to minimize or prevent them. The first compliance date is July 26, 2019.

Ryan Newkirk, senior advisor for intentional adulteration with the Food Defense and Emergency Coordination Staff at FDA, and Jon Woody, director of the Food Defense and Emergency Coordination Staff, talk about the new rule and what the FDA is doing to support industry compliance.

Q: Can you tell us in a nutshell what the rule is all about?

Newkirk:  Sure. The purpose of the rule is to protect food from a person or group of people who are intentionally doing something to the food to either cause illness or death on a large scale. The rule does this by requiring that certain facilities develop and implement a food defense plan.  It applies both to domestic facilities and foreign facilities that export food to the United States.

Q: Why isn’t adulteration that is economically motivated, such as substituting an ingredient for something cheaper, included in this rule?

Newkirk:  Economically motivated adulteration is very different because the goal is financial gain. We decided that addressing economically motivated adulteration worked better under the preventive controls framework, which focuses on hazards that are known or reasonably foreseeable. So the final rules on preventive controls for human and animal food address economically motivated adulteration if it can affect the safety of the food. Economically motivated adulteration that affects product integrity or quality, but not food safety, is out of the scope of those rules. Substitution for something cheaper could result in misbranding, which is subject to the provisions of the Federal Food, Drug, and Cosmetic Act.

Q: What does a food defense plan consist of?

Newkirk: There are several main components to the plan. First, facilities must conduct a vulnerability assessment, which means finding the points in their processes that pose the greatest risk for intentional adulteration. Second, facilities must put in place mitigation, or preventive, strategies to address these vulnerabilities. Third, a system must be put in place for food defense monitoring, food defense corrective action, and food defense verification, which together ensure the system is working as intended to address the vulnerabilities. Fourth is recordkeeping.  Finally, there are training requirements. Personnel, and their supervisors, working at the most vulnerable points in a facility are required to take food defense awareness training and to have the education, training, or experience to properly implement mitigation strategies. In addition, preparing the food defense plan, conducting vulnerability assessments, identifying mitigation strategies, and engaging in reanalysis activities must be done or overseen by personnel with additional training or experience.

Q: Are there certain foods that we are targeting with these food defense plans?

Newkirk:  No, on the contrary. One food is not inherently more at risk than another. It’s the processes that are the drivers of vulnerability.

Q: Can you give me an example of a vulnerability?

Newkirk:  Yes. Examples include an open access hatch on a large, liquid food storage silo or a very large mixing vat that is open without a lid. But keep in mind that these aren’t automatically vulnerabilities—it depends on the assessment carried out by the facility.

Q: I understand that the main components of the rule stem from more than 15 years of working with industry. Does that mean the requirements are familiar to industry?

Woody:  For the most part, yes. We began focusing on food defense back in 2001, working with other federal and state agencies that protect food. Assessing vulnerabilities and putting in place preventive measures to address them are familiar steps to the food industry. A presidential directive was issued in 2004 to require FDA and the U.S. Department of Agriculture to conduct food defense vulnerability assessments with industry. So we’ve had some time to learn what works and what doesn’t, and industry has played a major role in that. In fact, the main requirements of the rule come from our collaborative efforts with industry.

What’s new is that this is the first time that industry is required to take these steps—that part is novel. Up to now, food defense activities have been voluntary.

Q: If the major requirements are familiar, why have some members of the industry voiced concerns about this regulation?

Newkirk:  There is concern that the costs of complying with the rule are too high when considering the remote chance of an incident happening. We know that the likelihood of an incident happening is low, and thank goodness it’s low. But it’s not zero. And a single act could lead to wide-spread harm, causing illness, death and economic disruption of the food supply. If you look at the largest outbreaks of foodborne illness, you can see what could potentially happen.

We are aware that industry has many questions regarding implementation of the rule in their facilities and the costs associated with implementation. That is why we are working on draft guidance that will provide additional information to help industry comply with the rule. We believe that the information contained in the guidance will help address many of the concerns raised by industry.

Q: How are you responding to these concerns about costs?

Woody:  We’ve built as much flexibility into the rule as possible to keep costs down. This is by no means a “one size fits all” regulation. For example, we don’t specify what method must be used to conduct the vulnerability assessment. Any method is acceptable as long as it has certain elements. For example, we have identified four key activity types that FDA considers significant vulnerabilities. They are bulk liquid receiving and loading, liquid storage and handling, secondary ingredient handling, and mixing and similar activities. Instead of conducting a broader vulnerability assessment, a facility can identify actionable process steps for these specific activity types.

And we do not specify what preventive steps must be used. Companies have significant flexibility in choosing which mitigation strategies are most appropriate for them. Several years ago, we made available a free, Mitigation Strategies Database that contains examples of preventive measures.

Additionally, there is significant flexibility built into the requirements related to food defense monitoring, food defense corrective actions, food defense verification, and training.

Q: Did you visit any facilities to learn how food defense is being handled now?

Woody: Because of our long history of working on food defense, we’ve carried out many site visits —even before FSMA was enacted. We’ve seen many different types of facilities and products. Additionally, since the final rule published, we’ve continued with site visits, and our discussions with industry regarding their current food defense programs.

Q: Are there any exemptions to the requirements?

Newkirk: The law requires us to focus on the greatest risks and the areas of most concern, so we have been able to provide some exemptions to minimize the burden on industry. The rule is designed to primarily cover large companies whose products reach many people, exempting smaller companies. For example, the requirements do not apply to very small businesses averaging less than $10 million in sales per year. They do have to document that they are exempt, however. There are also other exemptions, including the holding of food, except for liquid food, and for farms.

Q: When do facilities have to comply with the requirements?

Newkirk:  Larger businesses—those that are not considered small or very small businesses under the rule—have until July 26, 2019 to comply with the requirements. Small businesses, which employ fewer than 500 people, have until July 27, 2020 to comply. Very small businesses are exempt from most of the requirements, but by July 26, 2021, they must document that they meet the requirement to be exempt. About 9,800 food facilities are covered.

Q: When can industry expect to see guidance documents? 

Newkirk: In August, we published a small entity compliance guide, and we are now working on the other guidance documents on topics such as conducting a vulnerability assessment; identifying and implementing mitigation strategies; and writing procedures for food defense monitoring, corrective actions and verification. We believe that the information contained in these guidance documents will help address many of the concerns raised by industry.

Q: What are your plans for training?

Woody: We need training for both industry and inspectors who will be checking to make sure the requirements are met. The Intentional Adulteration Subcommittee within the Food Safety Preventive Controls Alliance is developing food defense training resources for industry and inspectors alike. Training will include a combination of online and instructor-led formats, and we expect it to be ready by summer 2018. We’ve already initiated a series of webinars that can be viewed online  . And we are updating the Food Defense Plan Builder software, which now exists under our voluntary program.

Q: How soon after the compliance dates are reached will you begin inspecting?

Woody: When the compliance dates come, we first plan to do “quick check” inspections, which will be combined with other food safety inspections already scheduled. Inspectors will simply evaluate the food defense plans to make sure the required components are there. Our second stage of inspections will be more comprehensive and requires more detailed training for inspectors. You may have heard the phrase “educate before and while we regulate.” That certainly holds true for the intentional adulteration requirements. We believe a collaborative approach is the best approach for good compliance with the rule requirements.

For more information

• Food Defense
• Fact sheet on final rule on Intentional Adulteration
• Federal Register notice: Mitigation Strategies To Protect Food Against Intentional Adulteration

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Editor’s note: This column by FDA’s Steven Musser and Eric L. Stevens was originally published on the agency’s blog.

FDA is laying the foundation for the use of whole genome sequencing (WGS) to protect consumers from foodborne illness in countries all over the world.

We recently traveled to Geneva to join a meeting of the Codex Alimentarius Commission, an international organization that works to protect consumer health and promote fair practices in food trade. There, we participated in a panel discussion on how best to share WGS globally to fight foodborne illnesses and elicit support from the world’s governments in this effort.

There’s no time to waste.

The World Health Organization (WHO) estimates that as many as 600 million people in the world fall ill every year after eating contaminated food and 420,000 of these people die.

FDA has been a leader in the use of WGS to identify the nature and source of bacteria that contaminate food and cause outbreaks of foodborne disease. By sequencing the chemical building blocks that make up the DNA of these pathogens, WGS reveals their genetic fingerprint, offering clues about their geographic source, antimicrobial resistance, and other key markers that help scientists respond more effectively to food contamination, preventing illnesses.

In the last few years, WGS has fundamentally changed the way that we detect, identify and monitor microbiological food safety hazards within the United States. This technology is rapid, precise, cost-effective, easy-to-use, and can be applied universally to all foodborne pathogens.

The GenomeTrakr is an international network of laboratories sequencing microbial foodborne pathogens and uploading the data to a common public database in real time.

The goal of GenomeTrakr is simple: to assemble a large, freely accessible database of genetic sequence information and accompanying metadata, e.g. geographic location and date, from food, environmental and human clinical isolates of bacterial pathogens. This information can be used by scientists on the trail of disease-causing bacteria, unmasking each contaminant’s identity and offering clues to where and how it got into the food supply.

Recently, public health institutions, including FDA, WHO and FAO (the Food and Agriculture Organization of the United Nations), have been working to raise awareness about the importance of WGS and the benefits of sharing both sequence information and metadata.

In Geneva we talked about how this technology is being utilized in some countries to support their foodborne disease surveillance system or outbreak investigation activities. We all understand that food is a global commodity, with complex shipping and distribution networks that can easily result in contaminated food being sold in more than one country. Thus, the most effective use of WGS in foodborne disease surveillance requires coordination and collaboration, and the panel emphasized the global health benefit of every country sharing their data. One approach would be sharing the data through FDA’s GenomeTrakr.

We are certain that the public health benefit of WGS will only become more evident with every foodborne pathogen’s genomic sequence that is shared. Already, GenomeTrakr has collected more than 142,000 sequenced strains, has made them freely available to anyone in the world, and continues to demonstrate how a large database of this kind is being used effectively for food safety within the United States, and throughout the world.

As the food supply becomes increasingly global, the use of WGS in a way that crosses national borders will ultimately help keep us all safe from foodborne illness.

About the authors: Steven Musser, Ph.D., is the Deputy Director for Scientific Operations in FDA’s Center for Food Safety and Applied Nutrition (CFSAN). Eric L. Stevens, Ph.D., is a Staff Fellow in FDA’s Division of Microbiology at CFSAN.

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Editor’s note: This column was originally published by the Food and Drug Administration as a Voice Blog.

We have made dramatic changes in our response to complex, potentially high-risk food safety situations that may be difficult to address quickly.

Almost a year ago, we heard concerns that FDA was not doing enough to ensure that companies promptly and effectively initiate recalls of potentially dangerous food products in those rare instances in which a firm is not responding appropriately. FDA has always been committed to protecting the U.S. food supply, which is among the safest in the world, but we recognized the need to strengthen certain compliance and enforcement strategies in cases made more complex by factors that include the nature of the product, the scope of available evidence, and the company’s response.

And so, we took to heart issues raised by the Office of the Inspector General at the Department of Health and Human Services and have used them as a catalyst for change.

Not just change, but a culture change. At the heart of this change was the creation of SCORE, which stands for Strategic Coordinated Oversight of Recall Execution. We are the co-chairs of this group of senior leaders that gets involved in the most challenging food safety situations, working with field staff and district offices to evaluate the range of available options and deciding quickly what action to take. For example, SCORE can drive agency action if the company is not acting aggressively enough to recall their products, and can push for use of administrative or judicial remedies.

We now have FDA compliance, enforcement, and field leaders at the table, reviewing cases every week or more often, as needed. Science and medical officers are engaged in the conversation, as are field investigators, and lawyers.

What is the right action? What should FDA be doing? What should the company be doing? These are real time, high-level decisions, with the result being that field investigators are now empowered to immediately engage senior leaders in overcoming obstacles to the rapid removal from the marketplace of foods that are, or could be, contaminated. The process of raising a food safety issue up within the agency has thus been streamlined to put FDA leaders and field staff on the same page right away.

Among the thousands of product recalls that FDA oversees each year, SCORE has played a critical role in addressing the most significant risks to the public. SCORE’s involvement has ensured that multiple recalls involving high-risk products have been initiated, has improved tactical planning, and sped the use of enforcement tools when necessary.

In the past year, SCORE has been involved in cases that included lead contamination of dietary supplements, Salmonella contamination of powdered milk, E.coli O157:H7 in soy nut butter, and Listeria monocytogenes in hummus, soft cheese and smoked fish. In addition to facilitating recalls and import alerts for the detention of products entering the United States, SCORE initiated or expedited the process for suspending the registration of two food facilities, actions that block the facilities’ ability to distribute food.

The creation of SCORE is not the only change we’ve made. There is a new recall audit plan to assess the adequacy of a company’s recall efforts and more than two dozen procedural and policy changes that have either happened or are in the works. These include an expansion of public notification of recalls that may affect the most vulnerable consumers, including the very young and elderly.

Most companies readily initiate a voluntary recall when faced with evidence that their product is unsafe. But when there is an obstacle, we are determined to overcome it, using all of the tools we have available. We’ve always taken our job seriously and we’ve shown over the past year that we will use every opportunity to do it better.

Note on the authors: William Correll is the director of the Office of Compliance in FDA’s Center for Food Safety and Applied Nutrition. Douglas Stearn is the director of the Office of Enforcement and Import Operations in FDA’s Office of Regulatory Affairs.

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The FDA Food Safety Modernization Act (FSMA) heralded a new era of enhanced collaboration between the U.S. Food and Drug Administration and its counterparts in state governments across the country. State officials were instrumental in providing comments to help FDA create regulations that take into account the complexities of food production and are designed to be flexible and practical while meeting the agency’s public health goals.

As FDA passes from FSMA rulemaking to implementation, the states continue to have an important role in bringing to life the FSMA mandate that the prevention of illnesses, rather than response to outbreaks, should be the cornerstone of the nation’s food safety system. This is especially true when it comes to helping FDA implement FSMA’s produce safety rule, which, for the first time, establishes enforceable safety standards for the production and harvesting of produce.

In September 2016, FDA awarded 42 states a total of $21.8 million in cooperative agreements to develop produce safety programs that will enable them to deliver education and technical assistance to farmers and provide ongoing inspection, compliance and oversight.

Why is this collaboration so important in protecting the safety of the food supply?

Why does FDA need the states, and vice versa?

Erik Mettler, FDA’s acting deputy commissioner for foods and veterinary medicine, Richard Ball, New York’s commissioner of agriculture and markets, and Joseph Corby, executive director of the Association of Food and Drug Officials, talk about the evolution of this federal-state partnership.

Q: Why are the cooperative agreements with the states so important in implementing the produce safety rule?

Mettler: FDA cannot effectively and efficiently implement the produce safety rule alone. There are local, state and federal government roles to be played to be successful. We knew this from the start. Establishing these cooperative agreements helps leverage federal resources to provide the states the funding that they need to establish or expand their produce safety programs and ultimately make the food safety system work as a whole.

Ball: We’re going to rely heavily on our collaboration with FDA. Certainly, this funding to do the work, and collaboration to make sure the work is done the right way, is critical to the success of the program. So the states very much like the cooperative agreement approach to getting the job done and achieving the goal of enhanced produce safety for consumers.

Corby: It’s worth noting that produce safety may be the largest cooperative agreement between FDA and the states on food safety, but it’s not the only one. There are agreements to improve state laboratory efforts and FDA funding of Rapid Response Teams to respond to food emergencies. All of these agreements are part of building a successful food protection program and have been very useful to the states in building capacity.

Q: When FDA was establishing the produce safety cooperative-agreement framework, what was it hearing from the states? What drove this decision to award this funding?

Mettler: FDA knows that the states have already built long-term relationships with the growers; they understand their local circumstances better than FDA does.  FDA does not intend to conduct regular inspections of all of the farms covered by the produce rule. We can only accomplish the level of compliance needed to protect public health by partnering with the states to build on their established relationships and help farmers understand how to comply with this rule.  This will also allow FDA to deploy our resources to states that are not part of the cooperative agreement and to address imported produce.  At the end of the day we’re about protecting public health and public safety, and we felt it was best that this begin at the local level.

Ball: I really like the tone you used to express that.  We value our relationship with the growers every day.  We’re on the farms and we regularly meet with all of our commodity groups.  If we’re going to have success, it will ultimately depend on making it achievable for the grower community.  I’m a farmer myself – a vegetable grower, so I can appreciate both sides.  Being involved with the industry, I understood very quickly that food safety needs to be everybody’s business, not just the end user or the retailer or the wholesaler but the whole food system needs to have ownership of food safety.

Q: Could the states protect the health of their citizens without this kind of FDA involvement?

Corby: The states already do the overwhelming amount of food safety work, whether it’s inspections or surveillance. Local and state agencies are often first responders in food-related emergencies. When someone believes something they ate made them sick, they don’t usually call the FDA. They call someone local. That said, many food safety problems are multi-state in nature; recalls are often national; and many times imported foods are implicated. So we recognize that FDA has to be engaged in all of those circumstances.

Ball: And I would agree 100 percent with Joe.  State health and agriculture departments have been ensuring the quality and safety of food for a long time.  We’ve always had a strong relationship with FDA and we’ve always looked to FDA for guidance, as Joe mentioned, on large-scale challenges.  So even before FSMA, we had a partnership with FDA but now we can grow that partnership even more to achieve our goals.

Q: What challenges and critical issues do you see ahead, especially as it relates to the produce rule?

Mettler: Sustained funding through this cooperative agreement to build and maintain the program will always be key.  But I would like to emphasize that a key issue is continuing to do what we promised during the rulemaking, which is to educate while we regulate. At the local, state and federal levels, this is a learning process as we go along.  We really needed to sit down and listen to everyone as we developed the rule, but it’s just as important as we implement it.  Again, the key outcome here is public health and public safety and we need to make sure we can adjust when needed and also make sure that we’re not being an undue burden or hindrance to industry’s economic vitality.

Ball: As a farmer, I make a list for myself every day of things to do on the farm.  I do the same thing as Commissioner.  At the top of my list every day I write down the words “long view.”  As Erik said, for us the long view is public health and safety, and I agree that we must be able to rely on federal resources.  We need to stay on the same page and make sure we’re communicating and collaborating and making sure we understand what our goal is and that it’s a mutual goal.  I think that the farm community already recognizes that food safety needs to be a big part of its world every day.  I think they get it but again the notion of educating while we regulate just needs to be first and foremost in our minds.  I think the farm community wants to achieve this, they want to get it right, and they want to partner with us.  The challenge will be: How do we do that?  How do we communicate that?  How do we bring them along and raise the bar in a way that’s achievable?

Corby: I do look at this somewhat broadly because I think our big challenge is continuing to build out the effort to integrate the nation’s food safety system.  I would add that the states have been committed to an integrated system for about two decades now, ever since 1997-98 when AFDO first offered the vision for an Integrated Food Safety System.  Education while you regulate is something that state and local agencies have done for many years now and FDA’s commitment to do this is essential to our ability to coordinate our efforts.  I think we have to coordinate outreach and education efforts by all stakeholders because that can be done by government, by academia, and it can be done by cooperative extension.  I think that will be a challenge as we go forward.

Q: Is there anything that has surprised you about this FDA-state partnership?

Corby: I’ve worked in government for over 30 years and I’ve worked a lot with FDA and quite frankly I did not believe that FDA would be so receptive to this concept of educating while regulating.  That was the biggest surprise to me, and a very welcome one, I might add.

Mettler: I think our partnership has developed smoothly.  I’m sure there will be surprises along the way, but I don’t see them as challenges.

Q: How do you see the federal-state partnership evolving?

Mettler: This is a bright future and what we’re after at the end of the day is a fully integrated food safety system at all levels.  We have been using the concept of “educate while we regulate,” but I really think it’s more than that.  It’s really “educate before, during, and after we regulate” so we really do this at each step of the way.  Education through the entire process is key.

Ball: As we move forward, the notion of us as co-regulators, partners and collaborators is so vital to our success here. I think that when you value a relationship you nurture it, and we just need to be mindful of that.  We’ve got to recognize that we’re all trying to accomplish a common goal and continue working in that direction.  We all want this to be a success and the best possibility of achieving that is working together.

Corby: I think the relationship between the state and federal governments will keep getting better and better.  Based on what I’ve seen, there is clearly a much fuller respect and trust between agencies, whether it’s between state and local or between state and federal. There just is clearly more trust.

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Editor’s note: This blog by FDA’s Stephen Ostroff and Kathleen Gensheimer was originally posted by the agency as part of its “FDA Voice” series on June 28, 2016.

When many people buy flour, they empty it into a canister and throw out the bag. But three people at the center of a recent outbreak of foodborne illness didn’t do that. They kept their flour in the original packaging, and in so doing enabled the FDA to track down what was making people sick. The story of the recent recall of 10 million pounds of baking and cooking flour is one in which federal agencies, consumers and the food company – in this case, General Mills – all had a role in doggedly tracking down the source of an outbreak that has made dozens of people across the country sick and getting the suspect product off the market. It all began with a signal, or more accurately, with multiple signals that were monitored by FDA’s Coordinated Outbreak Response and Evaluation (CORE) network. This team looks for “signals” that may point to a pending outbreak, including reports of human illness from the Centers for Disease Control and Prevention (CDC), FDA-collected data on food samples and inspections, and related information on illnesses and inspections from state and local public health and regulatory agencies. The signals this time came from CDC, which in February identified a string of illnesses that began in December as an outbreak of infections caused by Shiga toxin-producing E. coli O121. This pathogen is a much less common cause of foodborne illness than its better-known cousin E. coli O157. Investigators began to interview patients about the foods they had eaten in the week before they became ill. But identifying flour as the source of the outbreak was not easy. Initially, it seemed that produce or other foods might be the culprit. Then there was a break. By April, investigators had found that all of the people interviewed in depth had been baking at home, and many of them said they used Gold Medal flour. Multiple interviewees also mentioned eating raw cookie dough that had been made at home with the flour. CORE was now faced with the daunting task of proving that specific batches of flour caused the majority of the illnesses. The reports from some patients could not initially be confirmed because key information about the brand and lot numbers was not available – it had gone out in the garbage with the flour bags. But in the weeks that followed, investigators made two important discoveries: Three people who had become ill still had the original flour package. Two of the labels showed that the Gold Medal Brand flour had been packaged at a General Mills facility in Kansas City, Missouri, and that they were packaged on consecutive days. The third was made at that plant within a week of the other two. And the FDA team became aware of illnesses linked to restaurants that would supply balls of raw dough for children to play with. These illnesses were among children who had eaten different meals at restaurants in separate states. The CORE team learned that the flour used by the restaurants during the estimated time of the children’s exposure was supplied by the same General Mills production facility. The FDA decided not to wait for laboratory confirmation that there was E. coli in the flour before contacting the company. On May 27, FDA and CDC investigators briefed General Mills leadership about the information they had received from patients and on May 31 the firm voluntarily recalled a massive amount of flour — 10 million pounds produced in the Kansas City plant over a three-week period in November and December of 2015. The FDA continued its analysis of a sample of flour collected from the home of a patient who had provided one of the labels. Laboratory microbiologists at the agency confirmed the presence of E. coli O121 in that flour sample. On June 10, FDA’s whole genome sequencing analysis of that sample also confirmed that the E. coli O121 was closely related genetically to bacteria found in people who had become ill. The final piece of the puzzle was put into place, although the investigation continues to ensure that all contaminated product is off the market. This was just one of the hundreds of voluntary recalls that the FDA facilitates every year. Going forward, the agency’s compliance and enforcement strategies, including recalls, will get even stronger with the recent establishment of a decision-making body of key senior leaders to identify timely and efficient measures to mitigate public health risks.

Laying the groundwork for a recall can be a complex and lengthy process, with only bits and pieces of information coming in at any one time. But tenacity, collaboration and a willingness to be proactive in protecting consumers, enabled the FDA, its federal, state, and local partners, and General Mills to quickly and efficiently work to recall a potentially dangerous product and keep even more people from becoming ill. Note on the authors: Stephen Ostroff, M.D., is FDA’s Deputy Commissioner for Foods and Veterinary Medicine. Kathleen Gensheimer, M.D., M.P.H., is the director of FDA’s Coordinated Outbreak Response and Evaluation (CORE) network. (To sign up for a free subscription to Food Safety News, click here.)

• determine which illnesses are part of an outbreak and which are not;
• determine which ingredient in a multi-ingredient food is responsible for the outbreak;
• differentiate sources of contamination, even within the same outbreak; and
• link small numbers of illnesses, including geographically diverse illnesses occurring across multiple states, that might not otherwise have been identified as a common outbreak.

Once a bacterium is sequenced, the generic information can be used indefinitely. The “evidence” doesn’t get used up, and scientists can continue to match strains from years past. Brown says the FDA is pushing the whole genome sequencing technology out to the frontlines of food safety “as quickly and completely as it can.” What does this mean for future tracking of food-borne illnesses? Industry is starting to recognize and use whole genome sequencing as a way to monitor ingredient supplies, determine the effectiveness of preventive and sanitary controls, and determine the persistence of pathogens within the factory environment, Brown says. If a food production facility finds a pathogen during testing, it can use the GenomeTrakr database to help identify the source of bacterial contamination and take whatever corrective steps are necessary to make sure the food it produces is safe to eat. Allard adds that the FDA is working with like-minded food industry specialists who are examining the value of whole genome sequencing for food safety as they work to produce the safest food possible. “We’re helping to raise the bar for food safety around the world,” Brown says. (To sign up for a free subscription to Food Safety News, click here.)

• Raw or undercooked meat or poultry
• Raw fish, partially cooked seafood (such as shrimp and crab), and refrigerated smoked seafood
• Raw shellfish (including oysters, clams, mussels, and scallops) and their juices
• Unpasteurized (raw) milk and products made with raw milk such as yogurt and cheese
• Soft cheeses made from unpasteurized milk, such as Feta, Brie, Camembert, blue-veined, and Mexican-style cheeses such as Queso Fresco, Panela, Asadero, and Queso Blanco
• Raw or undercooked eggs or foods containing raw or undercooked eggs, including certain homemade salad dressings (such as Caesar salad dressing), homemade cookie dough and cake batters, and homemade eggnog (most pre-made foods from grocery stores, such as Caesar dressing, pre-made cookie dough, or packaged eggnog are made with pasteurized eggs)
• Unwashed fresh vegetables, including lettuce/salads
• Unpasteurized fruit or vegetable juices (these juices will carry a warning label)
• Hot dogs, luncheon meats (cold cuts), fermented and dry sausage, and other deli-style meats, poultry products, and smoked fish — unless they are reheated until steaming hot
• Salads (without added preservatives) prepared on site in a deli-type establishment, such as ham salad, chicken salad, or seafood salad
• Unpasteurized, refrigerated pâtés or meat spreads
• Raw sprouts (alfalfa, bean, or any other sprout)

The four steps to food safety:

1. CLEAN: Wash hands and surfaces often.
2. SEPARATE: Separate raw meats from other foods.
3. COOK: Cook to the right temperatures.
4. CHILL: Refrigerate foods promptly.

For more information, see Food Safety for People with Cancer or call USDA’s Meat and Poultry Hotline at 1-888-MPHOTLINE (1-888-674-6854) and ask for a free copy.

• In a study published in the Journal of Applied and Environmental Microbiology, microbiologist Jie Zheng, Ph.D., and other FDA researchers explain how they set out to better understand how fresh tomatoes become contaminated with Salmonella. The researchers found that quality of the water is a key factor. Tomatoes can become contaminated at specific times during the growing season, indicating the importance of using clean water to irrigate at planting or when applying pesticides.
• In a study published in the journal BMC Microbiology, microbiologist Andrea Otteson, Ph.D., and FDA colleagues compared the tomato-growing environments of California, Virginia and Florida. The researchers are developing a baseline of microflora (including algae, fungi, and bacteria) associated with tomato crops at high or low risk of Salmonella contamination. The researchers are also considering other factors, such as the crops’ proximity to poultry farms—a potential source of Salmonella—or certain fungi in the soil. California has not had as many Salmonella outbreaks in tomatoes, and this research may be able to pinpoint the conditions on the East Coast that would be the safest for tomato crops, Otteson says.

The Practical Application So what does FDA do with all this information? The agency’s tomato research is shared on an ongoing basis with industry and agricultural extension systems at the state level. Steve Rideout, Ph.D., director of Virginia Tech’s AREC, says that he and his staff exchange research findings with FDA and share that information with growers. “There are still a lot of unknowns when it comes to contamination of tomatoes,” says Michael Mahovic, Ph.D., a consumer safety officer on FDA’s Produce Safety Staff. “But our research helps open a window.” Findings by FDA researchers were among the building blocks of the Proposed Produce Safety Rule mandated by the FDA Food Safety Modernization Act (FSMA), Mahovic says. The proposed rule would establish science-based standards for the production and harvesting of fruits and vegetables. FSMA gave FDA a mandate to implement a system that emphasizes prevention of risks to public health. The tomato industry has worked closely with FDA in setting its own safety standards, says David Gombas, Ph.D., senior vice president of the United Fresh Produce Association. Industry-wide safety guidelines were adopted in 2008. And in 2009, the industry issued food safety and auditing standards, commonly called the Tomato Metrics, for growers, greenhouse operators, and packers. Mahovic says FDA used these industry standards as the basis for its own draft guidance documents in 2009 that recommended ways in which microbial food safety hazards could be reduced throughout the tomato supply chain. Gombas says the tomato industry continues to have a close working relationship with FDA, with frequent meetings and conversations about the latest research. The industry provides FDA access to farms and crops. “We’re all working together on this,” he says. Studying the Genes There is another arm of this work for Team Tomato—researching the genes of the disease-causing bacteria. While the agency’s other research in field and lab focuses on preventing tomatoes from becoming contaminated, the goal of the gene research is to prevent illnesses once Salmonella is detected. FDA wants faster ways to track down the source of an outbreak of foodborne illnesses, explains Captain Thomas Hill, MPH, U.S. Public Health Service, an environmental health specialist in FDA’s Coordinated Outbreak Response Network, who is also a member of Team Tomato. “I come at this from the outbreak perspective. Part of our mission is to prevent the next outbreak.” Bell explains that the agency has been developing bacterial genetic sequences (the ordered chemical building blocks of DNA). This work will be part of a public database of bacterial gene sequences that will allow scientists to rapidly identify disease-causing bacteria and locate their source. “There has been a big data gap in the past, and we’re looking to correct that,” says Bell. Sound Science In addition to its focus on the prevention of foodborne illnesses, Team Tomato’s work advances another FDA priority: the use of sound science—in this case what we call regulatory science—to support the agency’s oversight of the nation’s food supply. “Team Tomato is one of the best examples of regulatory science that we have to offer,” says Brown. “The scientific information that Team Tomato has gleaned so far is helping to answer some very tough questions related to tomato safety and Salmonella in the farm environment.” Brown notes, “Considering the number of people who eat tomatoes, the rate of infection from Salmonella is very low. But it’s a very popular food, and we are determined to make that risk as low as possible.”

This article was originally published on the U.S. Food and Drug Administration’s FDA Voice blog on January 17.

And that’s what we’ll be doing this week. Our team of regional food experts will work with local health departments to protect food from contamination. We’ll review menus and observe food preparation, storage and service. We’ll train kitchen staff about risk factors, such as cleanliness, food temperatures and refrigeration. And information on food sources and supply chains at venues and vendors will be questioned so that if any foodborne illness is reported, we’ll have data to trace it back to the source.

Data from the 2009 inauguration tells us that our inspections covered more than 100,000 meals. We expect similar coverage this time around. It’s a privilege and an honor, but it’s also an enormous responsibility. Fortunately, we come prepared. We tackle this important challenge armed with years of valuable knowledge and experience in careful, data-based, cutting-edge science. We protect Americans from foodborne illness based on lessons learned over a long period of time. In ancient Rome, the emperors had special food tasters to make sure their feasts were safe and poison-free. Washington, D.C., isn’t ancient Rome, of course, and the “poisons” we are looking out for may be dangerous microbes. But just as the Secret Service is responsible for overall security at the inaugural events, FDA is responsible for managing food safety and security in the retail food venues. We’ll work with the chefs and food services and facilities staff in D.C. to ensure that food safety standards are met. As the FDA Food Safety Modernization Act makes clear, our focus will be on preventing food safety problems before they happen. The standards that FDA and our local health departments will be enforcing in the nation’s capital are the same as those we have in place every day for you and your families. Whether the lucky guests are at an inaugural ball or eating at a stand along the parade route, they can rest assured – as can you – that the regulations are the same for both, and that FDA is doing its part to help ensure that the food we all eat will be safe.