Food Safety Magazine

Cover Story | April/May 2017

Building an Integrated Food Safety System One Brick at a Time

By Joe Corby and Steve Mandernach

Building an Integrated Food Safety System One Brick at a Time

Abraham Lincoln was once quoted as saying, “Things may come to those who wait, but only the things left by those who hustle.” You must be wondering how long you have to wait before you begin to see the integrated food safety  
 system that government agencies have been promoting. Are there target dates, timelines and plans? Who are the ones who “hustle” while we wait?

Actually, food safety stakeholders should now be able to recognize with some clarity that the vision of an integrated food safety system (IFSS) is currently being implemented, and it is beginning to illustrate great promise. An IFSS really isn’t anything new, as it has been employed for some time now. Let’s look back to 1937.

The Elixir Sulfanilamide
Government’s response to the sulfanilamide episode in 1937 may have been the first truly integrated effort in food and drug safety control efforts. It was an exceptional effort that clearly saved lives. Not only were federal, state and local agencies involved, but doctors, pharmacists and the news media played roles as well.

During September and October 1937, sulfanilamide was responsible for the deaths of more than 100 people in 15 states, many of whom were children. This incident led to the passage of the 1938 Federal Food, Drug, and Cosmetic Act (FD&C Act), which increased the authority of the U.S. Food and Drug Administration (FDA) to regulate drugs.

Sulfanilamide was used to treat streptococcal infections and had been used safely for some time in tablet and powder form. In June 1937, S.E. Massengill Co. found that sulfanilamide would dissolve in diethylene glycol, and after testing it for flavor and appearance, began to market the product in liquid form. The company sent 633 shipments all over the country.

When deaths started to be reported, FDA set out to retrieve all shipments of the drug by utilizing their entire field staff of 239 inspectors and chemists. State and local health officials joined in the search as well.

This was not the easiest task as FDA had to track down the company’s 200 salesmen and review approximately 20,000 sales slips.

Without anyone really recognizing it, this entire response effort was, perhaps, the first instance of a fully national integrated system that included the coordination and persistence of multi-jurisdictional health agencies, along with the effective actions of the medical community and the news media. As a result, most of the elixir was recovered. Of 240 gallons manufactured and distributed, 234 gallons and 1 pint were retrieved; the remainder that had been consumed caused the deaths of the victims. Imagine how many lives would have been lost without an integrated response.

This event did more than hasten enactment of the FD&C Act. It also clearly demonstrated how food and drug safety is a national concern best addressed through a nationally recognized rule and a nationally integrated system designed to prevent such tragedies.

Early Efforts in Federal-State Coordination
Early efforts to improve federal and state coordination are marked by clear intentions. Seldom would anyone use the term “integration,” instead referring to “contracts,” “partnership” and “leveraging.” There were plenty of milestones that expanded the idea of the need for closer federal, state and local collaboration. Some of those milestones can be seen in the illustrated timeline.

While many federal statutes and regulations preceded the creation of the Food Safety Modernization Act (FSMA), it was this act that directed FDA to better coordinate food safety resources with its partners at the state, local, territorial and tribal levels. FSMA has had a huge impact on the IFSS effort. All previous visions and hopes of an IFSS were weakened and difficult to advance without the strength of a congressional mandate. Because of FSMA, the country could now truly begin to develop that IFSS aspired to by so many for so long.

Partnership for Food Protection (PFP)
The PFP is a group of dedicated professionals from federal, state and local governments with roles in protecting the food supply and public health. It is the structure used to coordinate activities by representatives with expertise in food, feed, epidemiology, laboratory science, animal health, environment and public health, and helps develop and implement the IFSS.

The PFP is a volunteer organization; its members dedicate their expertise, in addition to their regular job duties, because of their belief and support for an IFSS. Members enjoy the opportunity to work on collaborative public health projects with multi-jurisdictional officials and with representatives of the Association of Food & Drug Officials (AFDO), the National Association of State Departments of Agriculture, the National Environmental Health Association, the Association of State and Territorial Health Officials and the Association of Public Health Laboratories. Many working relationships have developed within the PFP, and they have been helpful when responding to a foodborne outbreak investigation, or simply in obtaining input on inspections, work planning or training activities.

Since its establishment, the PFP has utilized its workgroup structure to develop and implement procedures, best practices and other work products that would advance an IFSS. There are seven PFP workgroups: Compliance and Enforcement, Information Technology, Laboratory Science, Outreach, Surveillance, Response and Post-Response Training and Certification, Work Planning and Inspections.

The PFP has also established a strategic plan covering a 6-year period from fiscal year (FY) 2015 through FY2020. The plan focuses primarily on integrating functions related to domestically manufactured human and animal food. It is reviewed every 2 years to allow for adjustments. Although the focus for an IFSS is currently domestic, PFP principles and resource documents may be shared with foreign government partners to promote a global approach.

 

Collaboration Timeline

1913 The formation of the Federal Office of State Cooperation resulted from a formal request of the Association of Food & Drug Officials (AFDO). This new office eventually would become the U.S. Food and Drug Administration (FDA)’s Division of Federal State Relations and today is known as FDA’s Office of Partnerships.

1927 AFDO’s adoption of a Model Uniform Food Law provided a basic food law for the states that most all would adopt.

1968 The reorganization of federal health programs placed FDA into the U.S. Public Health Service (PHS).

1969 FDA begins administering sanitation programs for milk, shellfish, foodservice and interstate travel facilities to prevent poisoning and accidents. These responsibilities were transferred to FDA from other units of the PHS.

1997 AFDO President Dan Smyly, Florida Department of Agriculture & Consumer Services, addresses the Regulatory Affairs Professional Society Annual Conference held in Washington, DC, and the U.S. Department of Agriculture (USDA) Food Safety and Inspection Service Annual Federal/State Conference on Food Safety in Sacramento, CA, where he advises attendees of AFDO’s vision of a national IFSS. Furthermore, Smyly requests support from USDA and FDA to convene a meeting of a select group to develop the blueprint for a vertically integrated national food regulatory system.

1998 The National Food Safety System is formed following a 50-state meeting. Workgroups consisting of federal, state and local government officials begin developing projects to advance the vision of an integrated system.

2009 The PFP is established to help implement the recommendations from the 2008 50-State Workshop. The PFP will be designated the primary group to advance and build the IFSS. 

2011 FSMA is passed. It provides FDA with new enforcement authority related to food safety standards, gives the agency tools to hold imported foods to the same standards as domestic foods and directs FDA to build an IFSS in partnership with state and local authorities.

PFP Resource Documents
PFP workgroups have developed a number of resource documents that are shared with regulatory agencies nationally, including the following:

•    Quick Start Food Emergency Response Job Aids: These aids facilitate communication, coordination and planning among government agencies early on when an outbreak or food contamination is initially suspected or detected. The job aids include three flow diagrams that highlight key general, epidemiological and environmental tasks in the early stages of notification to promote an integrated response approach.

•    Best Practices for Improving FDA State Communications Recalls: This guidance document is intended to encourage and enhance timely, reciprocal communication of recall information among FDA, state and local government agencies during class I recalls and outbreaks. The goal of this document is to increase recall transparency, communication and sharing of information without unduly impacting the high workload of partner agencies’ recall staff.

•    Best Practices for the Use of FoodSHIELD during Food and Feed Incidents: These were created by the PFP Surveillance, Response and Post-Response workgroup as a guide to facilitate information sharing and communication for FDA, state and local food safety officials responding to a food or feed safety incident. FoodSHIELD is a secure, web-based communication, coordination, education and training platform for food safety and defense. Agencies use FoodSHIELD during response efforts to share information with stakeholders. This document provides instructions for utilizing the FoodSHIELD web-based system to share response information in real time. It provides instructions for building and managing a workgroup and recommends using a consistent nomenclature for naming files and documents while sharing information within the system.

•    Food/Feed Testing Laboratories Best Practices Manual: This manual addresses national standard laboratory practices to promote consistent and meaningful data from environmental and food/feed samples for compliance and surveillance.

•    National Program Standards Crosswalk Resource Paper: This document compiles information on standards and requirements that apply to food regulatory programs in four program areas: Grade A Milk and Milk Products, Manufactured Foods (excluding meat and poultry), Retail Food Protection and Molluscan Shellfish. It identifies commonalities and differences among the existing program standards.

•    Model for Local Federal/State Planning and Coordination of Field Operations and Training: This model and the effective communication between FDA and its multi-jurisdictional counterparts with overlapping jurisdictions are critical components of an IFSS. These activities facilitate the efficient use of limited government resources and promote the safety and security of the food supply. Planning and coordination of field operations as referenced in this document relate to the scheduling of inspections, sample collection and analysis, and the execution of assignments, response activities and compliance/enforcement actions. Best practices for planning and coordination of field operations as well as associated training serve as a basis for this document.

Training Summit
To successfully advance an IFSS, the importance of training has never been greater. Having a high-quality, skilled food protection staff requires agencies to maintain a comprehensive employee-training development program. In addition to the internal agency training conducted, food protection officials can take advantage of the training opportunities inside and outside government. Many of these opportunities are presented at an annual training summit FDA has sponsored since 2015.

In 2016, the Regulatory and Public Health Partner Training Summits brought together over 120 stakeholders. They represented regulatory associations and alliances, industry education foundations, academia, localities, states, international agencies (representing Mexico and Canada) and federal agencies ranging from the U.S. Department of Defense to FDA. They meet to collaborate on an unprecedented level to develop the concept of a National Curriculum Standard (NCS) and support the attainment of a competent workforce performing comparable work. Training Summit 2015 was organized around “Thinking Differently,” as the event was used to introduce an innovative approach to an NCS while meeting the Office of Regulatory Affairs (ORA) Executive and PFP Training and Certification workgroups’ goals.

The new approach to curriculum construction blends learner competencies and training content to build a unique, multidimensional curriculum framework. The framework not only involves competency development but also offers a ready-made training needs analysis, a barometer to measure the effectiveness of learning events and a learner pathway from entry into the organization through leadership positions. Training Summit 2016 continued introducing more detail to the NCS approach. It provided updates on progress made over the year and offered extensive engagement with participants to give them a hands-on perspective on the approach. To date, multiple frameworks have been created, representing retail and manufactured food, animal food and laboratory competencies needed by regulatory enforcement professionals. Establishing an NCS gets us one step closer to a competent workforce doing comparable work across all strategic partners.

Regulatory Program Standards
Regulatory program standards establish a uniform foundation for the design and management of multi-jurisdictional programs responsible for regulating human and animal food. There are three sets of standards for manufactured food, animal feed and retail food regulatory programs. The goals of the standards are to leverage resources and share common successes to build systems within regulatory food programs. Collaboration is fostered with regulatory partners by:

•    Encouraging programs to adopt the best practices and continuous improvement models contained within nationally recognized regulatory program standards and codes

•    Utilizing performance measures and metrics to identify priorities and measure effectiveness

•    Fostering partnerships through food protection task forces, technical support, program evaluation, funding, training and information technology

•    Enhancing laboratory services by promoting national program standards and accreditation

•    Conducting outreach programs to enhance food safety and public health

•    Promoting capacity building, accountability, cost efficiency, transparency and exchange of best practices

•    Facilitating enhanced communication and collaboration between internal and external stakeholders

•    Advancing a nationally integrated approach to food safety and public health

The Manufactured Food Regulatory Program Standards (MFRPS) are a critical component in establishing a national IFSS. The goal of the MFRPS is to implement a nationally integrated, risk-based food safety system. The MFRPS establishes a uniform basis for measuring and improving the performance of prevention, intervention and response activities of manufactured food regulatory programs in the United States. The development and implementation of the standards will help federal and state programs better direct their regulatory activities toward reducing foodborne illness.  

The Voluntary National Retail Food Regulatory Program Standards (Retail Program Standards) define what constitutes a highly effective and responsive program for the regulation of foodservice and retail food establishments. They begin by providing a foundation and system upon which all regulatory programs can be built through a continuous improvement process. The Retail Program Standards encourage regulatory agencies to improve and build upon existing programs. Further, they provide a framework designed to accommodate both traditional and emerging approaches to food safety. They are intended to reinforce proper sanitation (good retail practices) and operational and environmental prerequisite programs while encouraging regulators and industry to focus on the factors that cause and contribute to foodborne illness.

In support of this goal, FDA works cooperatively with multi-jurisdictional partners using a risk-based approach to leverage limited resources. The Retail Program Standards represent an important component of a comprehensive strategic approach to help ensure the safety and security of the food supply at the retail level.

The Animal Feed Regulatory Program Standards (AFRPS) were developed in 2011 by FDA and the Association of American Feed Control Officials. The standards establish a uniform foundation for the design and management of state programs responsible for regulating animal feed. By implementing the AFRPS, a state program will be better able to achieve and maintain programmatic improvements that help ensure the safety and integrity of the U.S. animal feed supply. A state’s implementation of the AFRPS also helps ensure a uniform and consistent approach to feed regulation among jurisdictions.

IFSS Toolkit
The IFSS Toolkit was developed by the International Food Protection Training Institute in conjunction with AFDO and FDA. The toolkit is specifically designed for all stakeholders involved in food safety and food defense. It can be used within an organization or by an interdisciplinary workgroup with knowledge and practical experience in food safety and food defense. Use of the IFSS Toolkit will provide a broader context for assessing an organization’s current integration efforts and identify potential areas for improvement, especially with respect to cross-agency/cross-discipline activities.

By using the IFSS Toolkit, stakeholders become more familiar with the roles and responsibilities of others, which can allow them to facilitate better communication and engender team building in the process. There are three basic goals of the toolkit:

1.    Better understanding of current integration efforts in their jurisdiction

2.    Identification of specific IFSS practices and activities that will improve the integration performance of all stakeholders

3.    Making of plans to im-plement those activities

Although the interdisciplinary workgroup is an ideal target audience, the IFSS Toolkit can be used by persons from a single program, agency or discipline, or even a single person within an agency who acts as a “champion” for the cause. Because integration is a team effort, however, such an approach is more limited in scope and might best be viewed as the initial steps that could later involve others.

The toolkit promotes a process in which users prioritize areas of integration (called focus areas) that are most important to the user’s organization and then systematically undertake three steps for each prioritized focus area:

1.    Describe current activities and procedures in the focus area and identify those in need of improvement.

2.    Prioritize recommendations to address needed improvements.

3.    Make plans to implement prioritized recommendations.

This approach allows workgroups to focus efforts and identify changes to improve integration that are most appropriate to effectively use limited resources within the program/agency/jurisdiction/organization/company.

The IFSS Toolkit can offer concrete ways to achieve compliance with many of the regulatory program standards and should be considered a resource by agencies involved in meeting the standards. For example, FDA’s MFRPS and the Retail Program Standards require that participating programs take many steps related to integration.

The IFSS Toolkit integration activities have been divided into six major focus areas (Figure 1): Communication, Roles and Responsibilities, Integration of Legal Authority, Resources, Emergency Response and Global Activities.

FDA Investments
FDA’s ORA and Office of Partnerships (FDA ORA/OP) promotes the increased quality of state and local government regulatory programs to improve overall consistency and confidence in the work by these agencies. FDA ORA/OP has made great investments in state and local agencies through contracts and cooperative agreements. For example, in FY2016, FDA ORA/OP invested $15.4 million to execute 93 contracts for state human and animal food inspections and $82.2 million to 592 grants/cooperative agreement awardees to support and advance state and local programs in the areas of program standards, rapid response teams (RRTs), laboratory accreditation and emergency response activities.   

While these investments have proven successful, there are a number of conclusions that can be made as the IFSS is built, including the following:

•    States will need more time for human and animal food preventive control regulations adoption, outreach and internal training/external education.

•    The Produce rule is a game changer and will require significant inspectional and cultural shifts in mindsets and protocols.

•    There remains a great deal of work to do and this work must be performed collaboratively to improve efficiencies and reduce duplication of effort.

•    Staff for federal, state and local agencies must maintain their expertise to perform important functions.

•    Stakeholders must recognize that flexibility is key in advancing a national system and that one size does not fit all.

•    Flexible, risk-based, multi-year work plans between FDA and state partners must be implemented.

•    Joint compliance actions should be piloted and considered for national implementation.

•    Multiple funding models that account for differences between state programs should be adopted and implemented.  

•    Collecting and sharing data electronically between FDA and state programs should not have insurmountable restrictions.

•    A means to measure the effectiveness of inspections and value of integration must be devised.

Much can be made, however, of the commitment of state and local programs to advancing an IFSS. States learn from pilots and successes that currently exist in other states. The following successful state activities have been employed to advance an IFSS:  

Maryland Office of Food Protection
The Office of Food Protection in the Maryland Department of Health and Mental Hygiene comprises four expertise centers: Center for Food Processing; Center for Milk and Dairy Product Safety; Center for Facility and Process Review; and Center for Food Defense & Emergency Planning, Preparedness and Response.

The centers manage all regulatory aspects of food processing in Maryland, have oversight of local health departments’ foodservice programs and work closely with the Maryland Department of Agriculture on the farming-related activities of the food supply chain.

For the past 5 years, the Center for Food Processing has been supported in part by an MFRPS award from FDA. This funding has been used to support and enhance the functioning of the Office of Food Protection by:

•    Adopting and implementing the best practices encompassed in the MFRPS program

•    Installing a Food Processing Standardization Officer

•    Supporting the training of staff as specialist courses become available

•    Supporting and developing an office-wide database system to track food facility licensing, inspections and history, and to provide a tool for management of office activities

•    Introducing the field use of computers by the staff during the course of inspections and investigations at food processing facilities and allowing the direct electronic storage and remote transfer of information to the office database

Over the same period, the Center for Food Defense & Emergency Planning, Preparedness and Response has been supported in part by an RRT award from FDA. The funding has been utilized to support the establishment of the State of Maryland RRT (SMarRRT). Maryland is a relatively small state with only a medium-size, in-state food industry. Consequently, a full-time, fully staffed RRT could not be supported. The model for SMarRRT that was adopted was to use the funding to establish two dedicated full-time staff in the Office of Food Protection: the SMarRRT Coordinator and the SMarRRT Communications Coordinator. The remainder of SMarRRT comprises an epidemiologist from the state epidemiologist’s office, an analyst from the state laboratory administration and a specialist from the Maryland Department of Agriculture. Each member of this group acts as a part-time member of SMarRRT and not only contributes their individual expertise to SMarRRT but is charged with acting as the gateway to other expertise in their parent group. This group together with the two dedicated SMarRRT members comprises the core of SMarRRT for all incidents.

Except in very small events, the core SMarRRT has insufficient resources to adequately respond to an incident. SMarRRT resources are therefore enhanced as needed by utilizing staff from the Office of Food Protection and local health departments. In addition to extra manpower, this approach brings specialist knowledge from the dairy, shellfish and retail programs as needed. To facilitate this surge capacity, SMarRRT has used FDA funding to provide additional RRT training to staff in both the Office of Food Protection and local health departments. Additionally, SMarRRT emergency Standard Operating Procedures (SOPs) have been built into the SOPs for all staff in the office and provided to the local health departments.  

Currently, SMarRRT is developing the use of geographic information system technology for emergency response applications, including foodborne illness outbreak tracking, traceback investigations, storm surge flooding, power outages, airborne plume events and waterborne contamination.

Much of what has been accomplished has also been used to help improve the local programs responsible for inspecting all retail foodservice facilities. Training has been provided and the state now corresponds daily with local authorities to inform them of recalls, outbreaks, etc.
    
Wisconsin Department of Agriculture, Trade & Consumer Protection (WDATCP)
WDATCP and the FDA Minneapolis District Office (MN-DO) have been developing a good process for sharing inspection reports, work plans and establishment inventories over the past 4 years. This has dramatically reduced duplicative or too closely scheduled state and federal inspections and assisted in verifying establishment inventories for each agency.

The collaboration markedly decreased the number and rate of duplication of routine inspections. This saves time and resources that can be redirected elsewhere and minimizes the burden on businesses.

As a component of this, FDA has been sharing unredacted establishment inspection reports (EIRs), which help serve as a baseline for WDATCP inspections. Wisconsin has built the ability to protect FDA information (reports) from state open-records laws. As an additional benefit, Wisconsin has utilized FDA inspections conducted in-state to be utilized toward meeting state inspection goals during severe staff shortages.

The FDA MN-DO investigations branch work plan was shared with WDATCP at the beginning of the fiscal year to allow WDATCP to insert “FDA placeholders” in their inspection work plan database. This indicates to state inspectors that FDA will be conducting an inspection at those businesses this year, so a WDATCP routine inspection is not needed. In addition, to account for the large number of FDA ad hoc inspections, a simple inspection query is run, and the results are provided to WDATCP approximately every 3 weeks, showing recent inspection accomplishments. This allows WDATCP to position additional placeholders for any inspected companies that weren’t originally identified on the FDA work plan, again reducing the number of duplicative inspections a company might see. In return, Wisconsin provides FDA with a quarterly report of the inspections the state has conducted, to help ensure businesses are not inspected sooner than 6 months between agency inspections. Business inventories are routinely shared to identify and match similar businesses and identify businesses unique to each inventory.

In FY2017, nine joint inspections were conducted (two of which were companies that were in the compliance process for both agencies). WDATCP shared voluntary compliance agreements with FDA, and FDA shared unredacted warning letters with WDATCP.

All of this has provided a solid foundation for an excellent working partnership between these two agencies, which benefits them both, as well as the industries they regulate.

Washington State Department of Agriculture (WSDA)
WSDA has been an active partner in several innovative partnerships that emphasize integration of the food/feed safety system. For example, WSDA is an active participant in various PFP workgroups and continues to be a recipient of RRT, Food Protection Task Force, MFRPS and AFRPS cooperative agreements granted by FDA. Due to the close working relationship and multi-jurisdictional collaboration experienced by these workgroups in these agreements, WSDA has met the implementation requirements of three AFRPS standards during the first year of a 5-year renewable agreement. As an example, compliance with the requirements of Standard 5 of AFRPS (Feed Related Illnesses or Death and Emergency Response), WSDA as a lead agency was well prepared to respond in a very coordinated and timely manner with several federal, state and local agencies in a recent event where a large number of mink deaths were potentially associated with an adulterated feed. This included informing other authorities, coordinating collection and submission of product samples, dissemination of results, investigations/inspections and stoppage of the activities.

The integration of multiple layers of government partners is not limited just to times of emergency responses. In August 2016, the Washington RRT created, coordinated and hosted a webinar symposium entitled “Radiation and Food/Feed Emergency Response.” The overarching goal of the symposium was to increase multi-jurisdictional awareness around roles and responsibilities of partners in the event where radiation has affected the safety of human and animal food.  

Another active demonstration of Washington State’s ongoing integrated food/feed safety system work is the Washington State Food Protection Task Force (FPTF). Created in 2012, the FPTF meets throughout the year with federal, state and local public health partners to facilitate collaboration and communication, and promote educational opportunities among the partners.  

The FPTF Recall Audit Improvement committee consisting of state agriculture, state health and local health representatives came together to develop a multi-jurisdictional recall response guide to improve communication between agencies. This guide contains a one-page description of the agencies in Washington that have a role in recall audit checks and public health protection. It also provides a field guide that has a standardized glossary of terms for recalls and tips on what recall information is helpful to share between agencies. The guide is expected to enhance communication between agencies, limit duplication of efforts and enhance efforts to protect public health.

Thanks to the WSDA Recall Coordinator housed in the Feed/RRT Program, FPTF also maintains a website that contains food and feed information that is available to the public.

New York State Department of Agriculture & Markets (NYSDAM)
There are two components of New York State’s food protection program that forge innovative, cutting-edge partnerships with FDA and serve as models for other states. NYSDAM’s Integrated Food Safety System Partnership program with FDA’s New York District Office and their “Imported Food Initiative” agreement with FDA’s Import Operations are most noteworthy.

The purpose of the Integrated Food Safety Partnership is to establish an agreement that coordinates the food protection efforts of NYSDAM’s Division of Food Safety and Inspection and the FDA’s New York District Office. This agreement reduces consumer risk, eliminates duplication, defines regulatory roles and improves channels of communication. It covers all manufacturing food establishments and food storage facilities licensed or inspected by NYSDAM. The agreement has demonstrated the effectiveness of integrating federal/state responsibility for the food manufacturing and storage industries.

The partnership includes data and information sharing, training, recalls and enforcement strategies. It also allows FDA and NYSDAM to share each other’s resources and authorities when necessary.

The Imported Food Initiative is a nationally recognized collaborative project for dealing with the overwhelming burden of imported foods. While the number of food products imported into this country has increased dramatically, FDA’s ability to handle this surge remains limited. The Imported Food Initiative, however, allows FDA and NYSDAM to work more collaboratively on imported-food oversight. This effort is considered essential to New York because of the number of imports that enter the country through this state and then, because of its diverse population, are marketed there. The domestic marketing channels include food warehouses, processing plants and retailers for which state and local food safety regulators are primarily responsible.

Although New York is a major entry point, food of imported origin offered for sale at state wholesale/retail establishments can, and does, enter the U.S. via more than 400 ports of entry nationwide. NYSDAM’s surveillance of foods of imported origin at the wholesale/retail level not only protects consumers in New York but also provides valuable information to FDA regarding how the national import program is working. Subsequent joint investigations of food products in violation enable FDA to determine why the violative food was not detected and detained, and take affirmative steps to do so in the future. A good illustration of the dilemma for state agencies with imported foods is depicted in Table 1. Of the 4,531 food recalls coordinated in New York since 2000, 3,234 of these (or 71%) involved foods of foreign origin. Of that amount, 2,710 (or 84%) were categorized as class I or class II.

With the Imported Food Initiative, NYSDAM and FDA have developed a better understanding of the laws and the authority each agency has over imported foods, and they merge and utilize them wherever necessary to control violative food imports. Both agencies share resources and will work jointly with foods of imported origin to make better decisions on products to be detained for examination at the border. In addition, both agencies share any intelligence and information they may have that relates to food of imported origin in domestic commerce. 

Integrated Information Technology Systems
In 2010, the Pennsylvania Department of Agriculture (PDA) in conjunction with 55 local health departments, implemented a new food safety inspection and licensing system, “USAFoodSafety.” The PDA recognized not only that they had this need but also that other states could benefit from this endeavor. Pennsylvania has made the solution available to other state/local governments through the National Agribusiness Technology Center (NATC). The NATC is a nonprofit entity that facilitates various activities such as enhancement requests and collaboration across the states. Since all development is done by a single software company, the enhancements are available at no additional cost to all states using the system.

Currently, 13 state food safety programs have implemented this solution, but more importantly, they have leveraged limited development funds to add several features and modules to the system. Many of the states were able to fund implementation and enhancement development by securing funds from FDA cooperative agreements and grants. The system helps states conform to FDA’s program standards.

Several states have developed modules in USAFoodSafety and they are made available to all states using the solution. For example, the Minnesota Department of Agriculture implemented tracebacks and recall functionality. The Iowa Department of Inspections and Appeals began to provide licensees uniform guidance documents associated with inspections, automated inspection report dissemination based on chain or owner, violation trends by chain or owner, a public-facing mobile app and an executive dashboard with broad search and summary ability of real-time data analytics for licensing, inspection, complaint and violations data. The dashboard received the AFDO’s Elliot O. Grosvenor Food Safety Award in 2016.

USAFoodSafety includes many functions for industry stakeholders as well as transparency for the public. There is an online system that allows management to automatically receive emails of all completed inspection reports for their brand and portals for facilities to electronically apply/renew their licenses. There also are portals for citizens to review inspection reports, giving them robust access to information. The adoption and collaboration of the USAFoodSafety solution between states leverages best practices in the food safety industry. This has allowed for increased communication, consistency and joint development for more uniform inspection methods and greater comparability of data analytics. The states also participate in user-group meetings that focus on setting priorities for the system, prioritizing development based on best practices in the industry and identifying potential areas for improvement and collaboration.

The next step of this process is working to build consistency in manufactured food inspections to allow for data exchange with FDA. Initial exchanges are scheduled to occur in mid-2017. The vendor is working with FDA and six states to pilot the National Food Safety Data Exchange, which will highlight the following capabilities between FDA and the states:

•    State-to-FDA Electronic Transmission: (Submitting) Contracted inspection results

•    FDA-to-State Electronic Transmission: (Receiving) Firm data

•    State-to-State Electronic Transmission: (Requesting, receiving and sending) Facility search

State and local government food safety regulations and programs remain a mainstay in protecting the U.S. food supply. An IFSS would allow for resource leveraging, minimize duplication of effort and improve agency response effectiveness. With the inclusion of oversight, regulatory program standards, FDA audits of state and local programs and federal funding, many of the barriers to implementation have been resolved. Even expected resistance to change and cultural barriers seem less of an issue now. It appears that the country is ready for an IFSS, and it is being built brick by brick.   

The authors wish to thank Alan Taylor, Maryland State Department of Health & Mental Hygiene; Peter J. Haase, WDATCP; Randy Treadwell, WSDA; Stephen Stich, NYSDAM; and Julianna Wittig, FDA, for their helpful contributions to the article.

Joe Corby is the executive director of AFDO.

Steve Mandernach is the bureau chief for food and consumer safety at the Iowa Department of Inspections and Appeals.

 

Categories: Management: Training; Regulatory: FDA, FSMA, Guidelines