Regulators Burdened by the Velocity of Innovation in Nontraditional Food Operations
By Angela Montalbano, Steve Moris, Elizabeth Shafer, Michael Kalish, Charlie Kalish, Kelsey Holloman, M.P.H., Peri Pearson, and Joe Corby
To remain viable in an ever-changing and competitive environment, food operations must remain active and focused on expansion. This may mean operators will enter nontraditional areas as a way to increase their brand and not allow themselves to be outpaced by others.
While consumers rightly insist on safe food, convenience and preference also remain an important part of what they desire, and the emergence of nontraditional food operations is addressing this desire.
Nontraditional food operations such as temporary food establishments, shared-kitchen operations, online food delivery programs, and even mobile food trucks will usually involve reduced investments, overall cost reductions, and lower maintenance. Due to these scaled-down operations, there are some limitations, including services, which can impact food quality and safety.
Food regulatory agencies can be challenged by these types of nontraditional food operations. In fact, they always have been. Many supermarkets now include full-scale restaurants, while restaurants are now delivering food directly to consumer homes themselves or through third parties. Cash-and-carry warehouses allow small stores and restaurants to pick up perishable and time/temperature control for safety (TCS) foods and transport them to their commercial facility in the back of their SUVs without any refrigeration at all. Ethnic foods can be found marketed everywhere, and some of them are a bit of a mystery to regulators. Have you ever tried bird’s nest soup? Can you resist the attraction of baluts? Call the police if you bump into bush meat! These are just a few examples of what regulatory agents can run into during daily routine inspections.
At the same time as these advances, scarce resources and citizen activism are resulting in the successful detection of foodborne outbreaks through crowd-based technology and whole-genome sequencing, further stressing regulatory resources.
And there’s no telling what the future might bring to foodservice. Dinner on demand already exists in many neighborhoods—and so do pop-up kitchens and food halls. Robots will provide precise formulations of ingredients for processing or preparation; they are already serving ice cream treats through vending machines, making pizzas, and cooking burgers. Temperature sensors and digital tracking devices are sure to change government inspection protocols and hopefully reduce food safety challenges for all stakeholders—but that is tomorrow, which is coming at breakneck speed. Today, regulators must address the challenges of the past and the present with an eye to what is around the next turn.
The following snapshot stories focus on nontraditional food operations, including mobile food vehicles, shared kitchens, and online food sales, and the challenges they present to regulatory authorities charged with the licensing and inspection of these operations. This, coupled with the changes in illness detection through citizen reporting mechanisms, provides continued opportunities for advancement.
My Meal Detective: Utilization of an Online Foodborne Illness Complaint System in Virginia
Historically, restaurant or facility-associated foodborne illness complaints in Virginia were reported by phone call to local health departments and entered into an environmental health database by the Virginia Department of Health (VDH) with other types of complaints and restaurant inspections. This process made it difficult to extract and analyze only foodborne illness complaints from the database. In an effort to standardize reporting, and more easily capture and analyze foodborne illness complaints, VDH created an online tool, My Meal Detective (MMD), in 2016.
This online tool is a public-facing website where consumers can easily report foodborne illness any time of day without having to call their local health department. The website is managed through a collaboration of the Office of Environmental Health Services (OEHS) and the Office of Epidemiology’s Foodborne Disease Epidemiology team. The goal of this tool is to streamline, standardize, and simplify the process for the public to report a foodborne illness believed to be related to a restaurant, retail food store, or foodservice facility in Virginia. This allows for a more efficient process for environmental health and epidemiology staff to follow up and track these complaints. Additionally, a series of videos on foodborne illness risk factors was created and included on the website and the VDH YouTube page to educate the public on common food safety issues.
The initial MMD complaint survey was embedded on the website. All fields were free text, which made the data difficult to analyze. In March 2018, the survey was updated and transferred into the VDH Research Electronic Data Capture (REDCap) system. The website survey form more systematically gathers demographic information, symptoms, and suspected source of illness from the complainant. When a survey is submitted, the REDCap system automatically generates and sends an email alert to the program’s inbox for triage by OEHS staff. Each complaint that is received for a food establishment is sent to the environmental health department of the local health district or to the Virginia Rapid Response Team (VA RRT) coordinator who forwards it to the Virginia Department of Agriculture Food Safety Program for further follow-up. A Job Aid, “Expected Response to Suspected Foodborne Illness Reports and Food Safety Concerns (Complaints),” was developed to provide guidance to local health districts tasked with responding to these reports. The Job Aid compiles information from the Center for International Forestry Research, the U.S. Food and Drug Administration (FDA), and the Minnesota Food Safety Center of Excellence into a quick reference document to provide a uniform environmental health response to reports of suspected foodborne illness and other complaints.
A campaign to advertise MMD began in 2018 to promote the website through VDH social media during the #FoodSafetyFridays messages and the distribution of MMD magnets. VDH collaborated with the VA RRT to create magnets that include the direct link to the reporting site and a QR code that users can scan with their mobile devices, which will take the user directly to the website. These promotional materials have been distributed at the State Fair of Virginia, local health districts, and other conferences and events throughout the Commonwealth and in nearby states.
As of December 1, 2019, over 1,091 online complaints of illness have been captured in the MMD database. Food establishments from all 35 VDH local health districts have been implicated in these complaints. Reports were received from complainants residing in 22 states and the District of Columbia. Females in the 30–39 age group submitted the most illness complaints. Diarrhea, nausea, and abdominal cramps were symptoms complainants reported most frequently. Fifteen percent of complainants saw a healthcare provider because of their illness. The majority of illness complaints received were from those who dined at a Virginia restaurant, followed by those who purchased food items from grocery or retail stores, convenience stores, mobile food units, catered events, and temporary food events. MMD reports led to the identification and investigation of eight foodborne outbreaks in the Commonwealth.
Implementation of the MMD website has improved Virginia’s ability to receive, analyze, and respond to foodborne illness complaints and identify foodborne outbreaks. The continued promotion and advertising of MMD will help raise awareness of the complaint system and educate Virginia consumers on the importance of food safety.
Food Safety: When Food Is as Close as Your Mouse
The online sale of food has been a growing trend in recent years, and as with any trend, the regulatory community has not quite caught up. Regulators want to protect public safety, but many times they are forced to have their heads in the sand because of resource issues, political pressure, and agency beliefs.
So, how big is this problem of online food sales? What is being sold? Is the food being sold inspected or regulated? Each food safety jurisdiction in the nation is asking itself these three questions, which spawned an intern project at the Kansas Department of Agriculture (KDA). The Food Safety and Lodging Program at KDA is responsible for the licensing and inspections of retail food stores, food establishments, restaurants, schools, mobile units, food processing facilities, food storage facilities, and lodging establishments.
This project started in May 2019, and over the next 3 months, an intern scoured social media looking for food being sold online. With multiple social media platforms, KDA decided to focus on food sales through Facebook. It was determined that the two most popular ways of selling anything on Facebook were through the Facebook Marketplace and private buy/sell/trade groups.
While researching these two selling platforms, the intern found 400 posts that involved selling food. The Facebook Marketplace is a virtual farmers market. Anyone can sell products, and anyone can buy products. The marketplace accounted for 82 percent of the food sales on Facebook, and the number of people this could reach is endless. After a screening process, the intern was accepted into 35 buy/sell/trade groups throughout Kansas, and these 35 private groups were visible by over 500,000 people and accounted for just over 18 percent of the food sales on Facebook.
Looking at food sales and matching them to KDA licensing risk categories, we found:
• 45.3% of the foods being sold were high-risk foods like entrées, meats, and seafood.
• 41.3% were medium-risk foods, including canned goods, eggs, and dairy.
• 13.3% were low-risk foods, mainly produce and baked goods.
The Food Safety and Lodging Program promotes public safety by regulating the production and sale of food products in Kansas. Even though it is a regulatory program, it promotes businesses and their growth. Program officials want to show the public that the program wants to see them succeed and that it is here to help them do that. Program officials believe that the program needs to share its message by giving those individuals and establishments the tools and education needed to keep the public safe from foodborne illness.
With this in mind, a number of messages were created to walk the fine line between education and regulation. Program officials wanted to give the information necessary to produce safe food and then work toward licensing and inspecting facilities instead of just having the heavy hand and shutting down these producers of food. In addition to these messages, the program created a page on the KDA website with the locations and contact information for all the incubator kitchens that have been inspected by the program to give an additional option for having a place to produce their food.
The next phase of this project was to find a way to contact the sellers of these food products through direct messages on Facebook. The goal was to work with the sellers and not to call them out in an open forum. The first idea was to create a fake account on Facebook so the program could start the direct messages. This is when the agency attorneys got involved and pointed out that this was in direct violation of Facebook rules. The argument that everyone else does it didn’t pass legal review. Legal also noted that program officials were trying to provide information to people breaking the food safety law in Kansas by also breaking the rules of Facebook.
It remains a challenge to provide guidance to Facebook food vendors to sell safe and inspected food while complying with Facebook user community standards.
Shared-Use Kitchens Make for “Shared” Food Safety Challenges
An incubator or shared-use kitchen (shared kitchen) is a space designed to provide multiple entrepreneurial food processors access to food processing equipment, allowing processors the opportunity to start up or grow their business with less start-up capital and continuing overhead.
A shared-kitchen space is typically rented space in a commercial setting and comes in a variety of forms. It may be a designated commercial shared kitchen, or it may be communal space in a restaurant kitchen, a church, or a firehouse. In all instances, it must comply with the local, state, and federal sanitary regulations.
With the demand for unique, local, and artisanal food on the rise in the U.S., the popularity and need for incubator kitchens has also increased. There are many resources and forums available to help this growing, diverse community understand food safety regulations. These resources include The Food Incubation Summit and The Food-Corridor©.
In many cases, shared-kitchen owners also provide small business assistance, including help with marketing, packaging, and labeling products, as well as legal assistance regarding food processing licenses, permits, and/or registrations.
Shared kitchens are not a new innovative and creative concept; they were in use in the early 1900s. During this time, community canneries were established and continued to operate through the Depression, with over 132 canneries operating simultaneously. In 1936, North Carolina alone had 579 canning centers and 971 other food preservation centers during the Great Depression era. The goals of these centers were to ensure food security, teach families to save their own surplus food produced in gardens, and to can as many quarts of food as possible. Although the goals may have changed, the concept and the need for food safety measures have not.
The shared-kitchen owner, the shared-kitchen operator, and the regulator are all responsible for protecting public health. Each entity must conform to regulations, Standard Operating Procedures (SOPs), and policies to ensure each product is appropriately labeled and safe for consumers. As of 2017, only two states had regulating agencies with regulations geared to shared kitchens: South Carolina (regulations only) and Georgia (regulations and guidelines).
The importance of good communication and open dialogue among the kitchen owners, the shared-kitchen operator, and the regulator cannot be overemphasized. Shared-use kitchens pose special challenges, including unconventional hours and various regulating entities overseeing food safety requirements. Many shared kitchens operate 24 hours a day; therefore, it is advisable for kitchen owners to maintain a production schedule for each operator that they can share with the appropriate regulator. Regulators can use this schedule to conduct the necessary sanitary inspections during working hours.
The fact that both a chocolate chip cookie and a bottle of kombucha can be produced in a shared-use kitchen also presents its own unique food safety challenges. Over the years, innovative, artisanal products, such as fresh bottled juices, protein-infused foods, fermented foods, craft beers, and a variety of ethnic foods, have flooded the marketplace. These products, often, may have been developed in a shared-use kitchen.
In addition, different food safety agencies across the U.S. are responsible for regulating shared kitchens. Shared-kitchen owners and operators should work with the appropriate local, state, or federal food safety agency to determine the regulations that apply to their food facility, food product, and/or food process.
In 2017, the Association of Food and Drug Officials (AFDO) recognized the lack of specific and uniform shared-use kitchen regulations nationwide and created a guidance document to help regulators understand basic food safety practices and requirements as they apply to shared-use kitchens. This guidance document was based on best practices found across the U.S. The New York State Department of Agriculture and Markets saw a similar need and is currently creating a guidance document for shared-kitchen owners and operators starting their business in New York State.
Key Best Practices for Shared Kitchens
• Complying with all applicable state and local codes and ordinances. Shared kitchens should collaborate with regulatory agencies to ensure the kitchen and all operators are properly licensed and/or permitted with the appropriate agency.
• Maintaining the building and property in an acceptable sanitary manner, including pest control measures and sufficient garbage disposal.
• Providing sufficient handwashing facilities, equipment washing and sanitizing facilities, and restroom facilities.
• Maintaining an incubator-kitchen operator schedule/calendar, including the date and time of processing. The calendar should be shared with the appropriate food safety regulatory jurisdiction when requested.
• Limiting operations to only those for which the kitchen has the appropriate equipment, space, and facilities for production.
• Maintaining a file for each kitchen operator, including but not limited to the business contract, business certificate, license, inspection results, and scheduled processes.
• Identifying their rental capacity to regulatory representatives and not rent beyond the identified capacity. Incubator owners may not overbook or schedule rentals in a manner such that the needed capacity exceeds the identified capacity and causes operators to process with insufficient production space.
• Having a method for dealing with storage for clients’ raw ingredients and finished product. This can be accomplished in various ways:
° Best practice indicates that individual operators’ storage spaces should be separated in locked cages if possible. All ingredients and finished products should identify the operator with designated storage spaces, labels, tags, etc.
° Operators can rent their own off-site storage, which should also be licensed and inspected. If the operator does not need storage, all ingredients must be purchased on the way to the kitchen and used during the rental period. Remaining ingredients must be discarded or used for personal consumption.
° Finished products must be delivered to accounts directly after they are manufactured. They must not be stored. The kitchen manager is responsible for ensuring that all ingredients used are commercially sealed.
• Providing guidance to incubator-kitchen operators regarding:
° Contract Agreements – The incubator-kitchen owner/manager should discuss the particular contractual agreement between the incubator kitchen and incubator-kitchen operator. The contract agreements may include, but not be limited to, rent, liability insurance, times of operations, list of foods to be produced in the kitchen, food safety SOPs, cleaning and sanitizing, regulatory agency inspection, licenses and permits.
° Jurisdiction – Various food safety regulatory jurisdictions throughout the United States will be responsible for regulating incubator kitchens. The local health departments will have jurisdiction in some cases, while state health or agriculture departments will have jurisdiction in others. Some states operate under a Memorandum of Understanding that will determine the appropriate jurisdiction.
• Once the appropriate jurisdiction has been determined, the applicant for an incubator-kitchen license will undergo a consultation with a representative from the appropriate regulatory agency. An on-site inspection must be performed by the regulatory agency prior to issuance of the license. The consultation should include a review of proposed business practices, the type of equipment to be used within the facility, food safety operations, and proposed menus, to include a list of all food items that the user intends to prepare, store, taste-test, develop, package, or otherwise handle or use for food-related purposes.
• As part of this consultation, the individual or entity should be required to provide a Food Safety Manager Certificate or equivalent in the licensee’s name or in the name of an employee of the licensee, if the licensee intends to prepare, taste, handle, package, prepare for storage, serve, or otherwise use food; the name, address, and license number of the shared kitchen(s) the user intends to lease space from; and a signed statement of intent, or lease, from the owner or operator of each licensed shared kitchen that the applicant intends to lease space from, including the start date and end date (if applicable) for the agreement.
• Based on the information provided, the regulatory agency will assess and assign a risk level to the shared-kitchen user. That risk level will be based on criteria provided in these guidelines. Additionally, the regulatory agency will review its records on the licensed incubator kitchen to confirm it is properly licensed and capable of supporting the proposed practices. The menu or product list will be reviewed and approved.
Food Trucks, Commissaries, and Food Safety in the Age of Meal Delivery
Mobile food facilities (MFFs), or food trucks, have always been understood as a scrappy, low-capital investment for starting, or extending, a food business. Today, fleets of high-tech MFFs are being increasingly considered by large retail and foodservice brands to be the investment needed to shorten the distance between shifting locations of online consumers and brick-and-mortar stores. Mobile-cuisine.com reports that industry revenue increased at an impressive annualized rate of 12.4 percent during the 5 years between 2014 and 2018. That growth could rise to $365 billion by 2030, at which time most meals currently cooked at home will instead be ordered online and delivered from either restaurants or central kitchens.
For food safety professionals responsible for mainstream brands, the challenges of temperature control and hygienic design are likely of particular concern. The issue is further complicated by the necessary role of a “commissary” (also known as a central preparation facility or base of operations). To address these issues, regulators and industry are well-positioned to collaborate to mitigate the U.S. Centers for Disease Control and Prevention’s five major risk factors and to develop an authoritative standard for hygienic design. The most salient risk factor for delivery is “improper holding temperatures.”
Minimize the opportunity for improper holding temperatures
The opportunity for microbial growth increases the longer it takes to prep, load, assemble, and deliver the food, which makes efficiency and speed a critical form of control for MFFs and couriers involved in meal delivery. As a reference, the 2017 FDA Food Code’s limit for time as a control is 4 hours for cold ready-to-eat (RTE) food and 6 hours for hot RTE food.
Below are a few points to consider for inspection of food trucks and commissaries:
• If an MFF is using a restaurant as a commissary, food ought to be prepared as close as possible to pickup time. MFFs should not be considered a means to turn over near-expiring foods.
• Encourage labeling of food (“For MFF”) and storing it in a designated location in a commissary. This will help create a culture of efficiency and transparency.
• While some restaurants may have a Hazard Analysis and Critical Control Points plan to conduct reduced-oxygen packaging (ROP), loading ROP food onto an MFF may be prohibited in your state. If it is allowed, documented measures to ensure temperature control are essential to prevent the growth of Listeria and toxin formation by Clostridium botulinum.
MFF manufacturers and software providers are tackling major risk factors, like improper holding temperature, in innovative ways. For example:
• Consumers’ real-time geo-location data can be used by brick-and-mortar restaurants and MFFs to triage orders to the most conveniently located facility, allowing operators to cut down on holding and delivery times while maximizing throughput.
• Order tickets can be based on the customer’s (or courier’s) ETA for pickup, further reducing the time between prep and consumption.
A panelist at AFDO’s annual conference (2019) from Uber eats shared that delivery times average below 20 minutes. While this may contribute to time as a public health control, it is still dependent on how long the food is held (and handled) during prep.
Authoritative hygienic design standard for MFFs
One would assume that food safety design requirements for MFFs would be consistent, given that all states (to some extent) have adopted some version of the FDA Food Code, which sports a sleek Mobile Food Establishment Matrix. However, the sections mentioned in the matrix fail to provide an exhaustive list of design requirements. In this vacuum, local departments of environmental health (DEHs) have created food safety criteria that are frequently inconsistent and occasionally in conflict.
Counties across Maryland require that sinks be equipped with air gaps. Code of Maryland Regulations does not specify the size of the air gap, but Prince George’s County requires a 1-inch air gap, while other counties in Maryland require a 2-inch air gap. Virginia (except for Loudoun County)is indifferent about the air gap, while California prohibits air gaps. Some counties allow casters, while Los Angeles prohibits them. Denver requires hand sinks that have a width and length of 10 inches, while most counties in other states allow for 9 inches.
There is clearly a disagreement on how an MFF ought to be designed hygienically, which prompts the question of when and how industry and regulators will harmonize design requirements. MFF regulations are especially complex because they are a confluence of food safety, mechanical, electrical, Occupational Safety and Health Administration, U.S. Department of Transportation, and fire safety codes. Perhaps the most effective way would be for the topic to be considered by a cross-functional working group for the FDA Food Code, which could then be incorporated into existing (or new) sections applicable strictly to MFFs. States would then be able to adopt the standard, paving the way for a less burdensome permitting process and a higher degree of confidence in MFF hygienic design.
Impact of complexity of the food produced and sold by mobile food trucks
Baked into many DEH MFF plan-check requirements is a sensitivity to the complexity of food and food handling operations. For example, is the food packaged or prepackaged? TCS or non-TCS? Raw or RTE? DEHs across the U.S. may want to take note of San Francisco Department of Public Health (SFDPH), which has devised a colorful matrix that very cleanly tailors requirements to these attributes. While many DEHs have developed helpful guidelines, these resources are static and can fail to address emerging trends and technological improvements. Many DEHs have already developed a framework for communicating with industry stakeholders. SFDPH periodically engages industry in mobile-food roundtable events in collaboration with other local DEHs in the San Francisco Bay Area. In addition, the City and County of Denver agencies, along with other local health jurisdictions, host the annual Denver Food Truck Symposium.
As MFFs increasingly fulfill online orders across the U.S., industry stakeholders have an interest in working with regulators to bolster consumers’ confidence in MFF hygienic design and operations. If you would like to help MFF operators in your county, consider reaching out to DEHs that have established a communication framework with industry. And keep updating those amazing FAQs!
Making Innovation the Positive It’s Meant to Be Wins the Race
The ever-evolving food industry continues to advance at a pace well beyond regulatory capacity to quickly address emerging issues. At the same time, illness investigation and reporting methods have greatly advanced and result in quicker and often more frequent and smaller outbreak investigations, and regulatory resources are taxed to address new, novel, and emerging issues constantly. Today, new food business ideas expand across the country in a matter of months rather than years. The rate of innovation makes it difficult for regulators to adapt regulations for new models and obtain the resources to address the issues with the speed desired by the industry and in many cases, the public. Often, this results in new practices being deployed nearly nationwide before a thorough regulatory review.
The “Era of Smarter Food Safety” championed by FDA and Deputy Commissioner for Food Policy and Response Frank Yiannas recognizes the challenge of the pace of evolution in the retail sector and the need for more agile regulatory policy development in new and emerging areas. This framework also recognizes work to improve outbreak investigation and response, and focus resources on root-cause analysis. Together, FDA, regulatory agencies, and the food industry are focusing on the future and velocity of the change that continues to impact public safety.
Angela Montalbano is a supervising food inspector at the New York State Department of Agriculture and Markets. Steve Moris is program manager at the KDA Food Safety and Lodging Program. Elizabeth Shafer is program quality manager at KDA. Michael Kalish is formerly of Food Safety Guides. Charlie Kalish is a food safety and compliance consultant and owner of Food Safety Guides. Kelsey Holloman, M.P.H., is the assistant foodborne disease epidemiologist at the VDH, Peri Pearson is the state food consultant with the Environmental Health Services at the VDH, and Joe Corby is a senior adviser at AFDO.
1. Bird’s nest soup is extremely rare and extremely valuable. Produced from the nest of the swiftlet bird, it costs anywhere from $2,500 to $10,000/kg, resulting in a single bowl of soup that can cost anywhere from $30 to $100.
2. A balut is a developing bird embryo (usually a duck) that is boiled and eaten from the shell.
3. Bush meat is meat from wildlife species including mammals, reptiles, amphibians, and birds that are hunted for human consumption in tropical forests.