by joe corby and steve mandernach - ifpti€¦ · fiscal year (fy) 2015 through fy2020. the plan...

By Joe Corby and Steve MandernachRep R i nted f Rom food Saf et y maga z i n e , ap R i l/may 2017, w ith p eR m i SS ion of th e p u b l i Sh eR S .

© 2016 by th e taRget gRou p • w w w.foodSaf et ymaga z i n e .com

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 any-thing 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 excep-tional 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 in-cident 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 sales-men and review approximately 20,000 sales slips.

Rep R i nted f Rom food Saf et y maga z i n e , ap R i l/may 2017, w ith p eR m i SS ion of th e p u b l i Sh eR S .© 2016 by th e taRget gRou p • w w w.foodSaf et ymaga z i n e .com

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 ac-tions 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 vic-tims. 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 “leverag-ing.” 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 (p. 40). While many federal statutes and regula-tions preceded the creation of the Food Safety Modernization Act (FSMA), it was this act that directed FDA to better coor-dinate 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 ad-dition 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 Agricul-ture, 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 in-put 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 ad-vance 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 stra-tegic plan covering a 6-year period from fiscal year (FY) 2015 through FY2020. The plan focuses primarily on integrat-ing 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 prin-ciples and resource documents may be shared with foreign government partners to promote a global approach.

PFP Resource Documents PFP workgroups have developed a number of resource documents that are shared with regulatory agencies nation-ally, including the following:• Quick Start Food Emergency Response

Job Aids: These aids facilitate commu-nication, coordination and planning among government agencies early on when an outbreak or food con-tamination is initially suspected or detected. The job aids include three flow diagrams that highlight key general, epidemiological and envi-ronmental 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 un-duly impacting the high workload of partner agencies’ recall staff.

• Best Practices for the Use of Food-SHIELD during Food and Feed In-cidents: 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 respond-ing to a food or feed safety incident. FoodSHIELD is a secure, web-based communication, coordination,

FOOD SAFETY SYSTEM

“Early efforts to improve

federal and state coordination are marked by clear

intentions.”


education and training platform for food safety and defense. Agencies use Food-SHIELD 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 require-ments that apply to food regulatory programs in four program areas: Grade A Milk and Milk Products, Manu-factured Foods (excluding meat and poultry), Retail Food Protection and Molluscan Shellfish. It identifies com-monalities 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 fa-cilitate 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 great-er. Having a high-quality, skilled food protection staff requires agencies to maintain a comprehensive employee-training development program. In addition to the inter-nal 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 to-gether 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. De-partment 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 Sum-mit 2015 was organized around “Thinking Differently,” as the event was used to in-troduce 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 posi-

tions. Training Summit 2016 continued introducing more detail to the NCS approach. It provided updates on prog-ress made over the year and offered ex-tensive 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 estab-lish a uniform foundation for the design and management of multi-jurisdictional programs responsible for regulating hu-man 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 sys-tems within regulatory food programs. Collaboration is fostered with regulatory partners by:• Encouraging programs to adopt the

best practices and continuous im-provement models contained within nationally recognized regulatory pro-gram standards and codes

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

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

• Enhancing laboratory services by promoting national program stan-dards and accreditation

• Conducting outreach programs to enhance food safety and public health

• Promoting capacity building, ac-countability, cost efficiency, transpar-ency and exchange of best practices

• Facilitating enhanced communica-tion and collaboration between inter-nal and external stakeholders

FOOD SAFETY SYSTEM

“To successfully advance an IFSS,

the importance of training has never

been greater.”


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 improve-ments 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 orga-nization’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 integra-

tion efforts in their jurisdiction2. Identification of specific IFSS practices

and activities that will improve the inte-gration performance of all stakeholders

3. Making of plans to im-plement those activitiesAlthough the interdisciplinary work-

group 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 sys-tematically 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 im-prove 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 in-volved 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.

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

The Manufactured Food Regula-tory 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 perfor-mance of prevention, intervention and response activities of manufactured food regulatory programs in the United States. The development and implemen-tation 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 Pro-gram Standards) define what constitutes a highly effective and responsive pro-gram for the regulation of foodservice and retail food establishments. They begin by providing a foundation and system upon which all regulatory pro-grams can be built through a continu-ous 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 approach-es to food safety. They are intended to reinforce proper sanitation (good retail practices) and operational and envi-ronmental prerequisite programs while encouraging regulators and industry to focus on the factors that cause and con-tribute 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 impor-tant 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

FOOD SAFETY SYSTEM


“State and local government food safety regulations and programs remain a mainstay in protecting the U.S. food supply.”

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 consis-tency and confidence in the work by these agencies. FDA ORA/OP has made great investments in state and local agencies through contracts and cooperative agree-ments. 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 invest-ments have proven suc-cessful, 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 preven-tive control regulations adoption, outreach and internal training/exter-nal education.

• The Produce rule is a game changer and will require significant in-spectional 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 imple-mentation.

• 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 Men-tal 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 depart-ments’ 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 Of-fice of Food Protection by:• Adopting and implementing the

best practices encompassed in the MFRPS program

• Installing a Food Processing Stan-dardization 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 comput-ers by the staff during the course of inspections and investigations at food processing facilities and allow-ing the direct electronic storage and remote transfer of information to the office database

Over the same period, the Center for Food Defense & Emergency Plan-ning, Preparedness and Response has been supported in part by an RRT award from FDA. The funding has been utilized to support the establish-ment 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 fund-ing to establish two dedicated full-time staff in the Office of Food Protection: the SMarRRT Coordinator and the SMarRRT Communications Coordina-tor. The remainder of SMarRRT com-

FOOD SAFETY SYSTEM


• ED

UCAT

ION

• COM

PETE

NCY-BASED TRAINING • PERSONNEL CERTIFICATION • PERFORMANCE O

UTCOM

ES • COD

ES OF PRACTICE • VOLUNTARY MEASURES • TECHNOLOGY • RESEARCH • L

AWS/R

EGULA

TION

S • S

TAN

DARD

S

PREV

ENTI

ON INTERVENTIO

N

RESPONSE

DEPARTMENTSHEALTH

AGENCIES

REGULATO

RY

ASSO

CIA

TIO

NS

ENFORCEMENT

LAWFO

OD BANKS

SALVAGE/

CON

SUM

ERCO

NSU

MERS/

GR

OU

PS

ACADEM

IA

PRODUCERS DISTRIBUTORS&TRANSPORTERS RETAILERSPRO

CESSOR

STHIR

D-P

ART

YA

UD

ITO

RS

SAFE FOOD

Strategies

Tips & Metrics

Stakeholders

Goal

Figure 1. The IFSS Toolkit Focus Areas

District Office (MN-DO) have been developing a good process for sharing inspec-tion reports, work plans and establishment inventories over the past 4 years. This has dramatically reduced duplicative or too closely scheduled state and federal inspec-tions and assisted in verifying establishment inventories for each agency. The collaboration markedly decreased the number and rate of duplication of rou-tine 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 in-spection 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.

prises an epidemiologist from the state epidemiologist’s office, an analyst from the state laboratory administration and a specialist from the Maryland Depart-ment 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 gate-way 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 en-hanced as needed by utilizing staff from the Office of Food Protection and local health departments. In addition to extra manpower, this approach brings special-ist knowledge from the dairy, shellfish and retail programs as needed. To fa-cilitate this surge capacity, SMarRRT has used FDA funding to provide ad-ditional RRT training to staff in both the Office of Food Protection and local health departments. Additionally, SMarRRT emergency Standard Operat-ing Procedures (SOPs) have been built into the SOPs for all staff in the office and provided to the local health depart-ments. Currently, SMarRRT is developing the use of geographic information sys-tem technology for emergency response applications, including foodborne ill-ness outbreak tracking, traceback inves-tigations, storm surge flooding, power outages, airborne plume events and waterborne contamination. Much of what has been accom-plished has also been used to help improve the local programs responsible for inspecting all retail foodservice facili-ties. 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

FOOD SAFETY SYSTEM

Collaboration Timeline1913 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.


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 rou-tine 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 accomplish-ments. This allows WDATCP to position additional placeholders for any inspected companies that weren’t originally identi-fied on the FDA work plan, again reduc-ing the number of duplicative inspections a company might see. In return, Wiscon-sin provides FDA with a quarterly report of the inspections the state has conducted, to help ensure businesses are not inspect-ed sooner than 6 months between agency inspections. Business inventories are rou-tinely 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 volun-tary compliance agreements with FDA, and FDA shared unredacted warning let-ters with WDATCP. All of this has provided a solid founda-tion 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 em-phasize 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 experi-enced 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 AF-RPS (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, dis-semination 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, coor-dinated and hosted a webinar symposium entitled “Radiation and Food/Feed Emer-gency 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 Washing-ton 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 communica-tion, and promote educational opportu-nities among the partners. The FPTF Recall Audit Improvement committee consisting of state agricul-ture, state health and local health rep-resentatives 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 Wash-ington 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 communi-cation between agencies, limit duplica-tion of efforts and enhance efforts to protect public health. Thanks to the WSDA Recall Coordi-nator housed in the Feed/RRT Program, FPTF also maintains a website that con-tains 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 part-nerships with FDA and serve as models for other states. NYSDAM’s Integrated Food Safety System Partnership pro-gram with FDA’s New York District Office and their “Imported Food Initia-tive” agreement with FDA’s Import Op-erations 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 Divi-sion of Food Safety and Inspection and the FDA’s New York District Office. This agreement reduces consumer risk, eliminates duplication, defines regula-tory roles and improves channels of communication. It covers all manufac-

FOOD SAFETY SYSTEM

“An IFSS would allow for resource

leveraging, minimize

duplication of effort and improve

agency response effectiveness.”


turing food establishments and food storage facilities licensed or inspected by NYSDAM. The agreement has demon-strated 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 al-lows 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 overwhelm-ing burden of imported foods. While the number of food products imported into this country has increased dramati-cally, 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, pro-

FOOD SAFETY SYSTEM

cessing plants and retailers for which state and local food safety regulators are primar-ily 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 coor-dinated 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 im-ports. 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 licens-ing 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

Class I

722508 Imported214 Domestic




3021 Imported 9 Domestic



Class II

1,8001,395 Imported405 Domestic







Class III








Totals





218 146 Imported72 Domestic


4,5313,234 Imported1,297 Domestic

Year

2000–2010

2011

2012

2013

2014

2015

Total 2000–2015

Table 1. Summary of Recalls Coordinated by NYSDAM between 2000 and 2015


the states. Since all development is done by a single software company, the enhance-ments 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 fea-tures and modules to the system. Many of the states were able to fund implementa-tion and enhancement development by securing funds from FDA cooperative agree-ments 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 por-tals for citizens to review inspection reports, giving them robust access to informa-tion. 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 de-velopment 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 sched-uled 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 capa-bilities 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) Facil-

ity search State and local government food safety regulations and programs remain a main-stay in protecting the U.S. food supply. An IFSS would allow for resource leverag-ing, 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. n

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.

FOOD SAFETY SYSTEM
