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04/17 2017 ISSUE:752

Building an Integrated Food Safety System One Brick at a Time
Source :
By Joe Corby and Steve Mandernach
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.
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.

General Mills Invests $16 Million in Food Safety
Source :
By Staff (Apr 14, 2017)
Earlier this week, General Mills released its 2017 Global Responsibility Report. The annual document explains the brand’s approach to creating environmental, social and economic value in the countries where it operates. One of the key highlights in this year’s report is that General Mills boosted its spending on food safety from $13 million in 2015 to $16 million in 2016. This increase represents 8 percent of the company’s essential capital investment in 2016 that was dedicated to food safety projects.
General Mills has trained over 600 quality professionals and has more than 55 certified quality engineers monitoring food safety across the globe.
All of General Mills’ facilities are audited and/or certified by third-party vendors using globally recognized food safety criteria.
80 percent of General Mills’ owned production facilities are Global Food Safety Initiative-certified.
“Safety is a priority focus area for our company leadership and part of our culture. Leading with safety – both the safety of our employees in the workplace and the food they make – is one of the key operating principles that guides our work.” says the report.
Part of General Mills’ dedication to safe foods includes collaborating with suppliers, partners, industry peers and regulators. Previously, the brand has worked to establish and share best practices with the Grocery Manufacturer’s Association, the Food Safety Learning Alliance, and the Joint Institute for Food Safety and Applied Nutrition.
In terms of proper sanitation, General Mills has invested in its very own Global Sanitation Center of Excellence that trains employees as well as suppliers and co-producers on proper sanitation techniques.
As a prevention step, General Mills regularly conducts mock recalls at its warehouses, production facilities and co-production sites worldwide. Results are shared annually as part of a global report. The company conducted 10 voluntary recalls in fiscal 2016, including some of the brand’s Gluten-Free Cheerios, flour, and cake mix products. In reality, the brand suffered a number of food recalls in 2016--Gold Medal flour and Betty Crocker cake mix both due to Escherichia coli contamination, frozen vegetarian meals due to Listeria, and granola bars also due to Listeria.
In fiscal 2016, General Mills increased training to support compliance with the U.S. Food Safety Modernization Act (FSMA)’s Preventive Controls Rule. More than 120 employees participated in Preventive Controls Qualified Individual training, four employees were trained as lead instructors and one person was certified to train the trainers, helping the company to scale this knowledge across the organization.
General Mills employs 39,000 workers in 32 countries and has 59 production facilities worldwide.
See the company’s 2017 Global Responsibility Report in its entirety on their official website.
State oyster recall underway on Pacific Northwest coast over Norovirus
Due to multiple reports of oyster-associated Norovirus-like illnesses, Washington State is conducting a recall for all shellfish harvested from 3/15/17 to 4/11/17 from the implicated portion of the Hammersley Inlet growing area.   The area of the recall has been closed.
At this time the following companies are identified in this recall include:  Calm Cove Shellfish Company, Clearwater Shellfish, Gomez Shellfish, Goodro Shellfish, National Fish and Oyster Company, Navy Yard Oyster Company, Padden Seafood, Rivera’s Shellfish, Russ Shellfish, S and B Shellfish Company, Salazar Shellfish, Schreiber Shellfish, and Sea Fresh Farms.






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State oyster recall underway on Pacific Northwest coast over Norovirus
Source :
By NEWS DESK (Apr 14, 2017)
Due to multiple reports of oyster-associated Norovirus-like illnesses, Washington State is conducting a recall for all shellfish harvested from 3/15/17 to 4/11/17 from the implicated portion of the Hammersley Inlet growing area.   The area of the recall has been closed.
At this time the following companies are identified in this recall include:  Calm Cove Shellfish Company, Clearwater Shellfish, Gomez Shellfish, Goodro Shellfish, National Fish and Oyster Company, Navy Yard Oyster Company, Padden Seafood, Rivera’s Shellfish, Russ Shellfish, S and B Shellfish Company, Salazar Shellfish, Schreiber Shellfish, and Sea Fresh Farms.
State officials believe  that the implicated shellfish companies are in the process of contacting their customers. The state will provide additional information and details of distribution as it becomes available.  Local health jurisdictions are aware of the recall, but are not being asked to participate in formal recall verification activities at this time.
Following reports of norovirus-like illnesses in people who report eating raw oysters from several areas in Washington and elsewhere, public health officials at the Washington State Department of Health have tracked down areas where some of the illness-linked oysters were harvested.
Over the past several weeks, small harvest closures and recalls have been ordered, the largest of which is in Hammersley Inlet in Mason County, where a recall has been issued for any shellfish harvested there since March 15.  Smaller portions of the shellfish harvesting area were closed and shellfish recalled on March 2, April 4 and April 5.
The three-mile stretch of commercial shellfish growing beds is about two-thirds of the Hammersley Inlet growing area and is harvested by 31 shellfish companies. Shellfish harvested from the area is typically shipped to many states and countries. Shellfish growers and the Department of Health are working with local health jurisdictions and other states to track down all harvested product to make sure it is not available to be consumed.
“We are actively evaluating all potential pollution sources in the area to determine what is causing the contamination. The area will remain closed until we can assure that public health is protected,” said Rick Porso, Director of the Office of Environmental Health and Safety. “This issue underscores the importance of protecting our marine water, especially in areas where shellfish are grown.”
Norovirus is a common stomach virus that spreads easily. It can be transmitted through contaminated food or surfaces and person-to-person contact. The source of norovirus is people — specifically, the feces and vomit of infected individuals. The virus can be present in marine water indirectly through boat discharges, failing septic systems, malfunctioning wastewater treatment plants, or directly from an infected person. Because shellfish are filter feeders, they can concentrate the virus and infect individual that consume them raw or undercooked.
Norovirus symptoms include watery diarrhea, vomiting and stomach pain. Most people get better within two days. Dehydration can be a problem among some people, especially the very young, the elderly, and people with other illnesses. For those consumers concerned about the increased risk of illness, ordering and eating cooked shellfish is an effective way to prevent norovirus illness.
The Department of Health is responsible for the safety of commercial shellfish harvested in the state. The agency’s Office of Environmental Health and Safety uses national standards to classify all commercial shellfish harvesting areas. People who gather their own shellfish should always check the Shellfish Safety Map to learn about closures or health warnings.

Your kitchen also needs spring cleaning … for food safety
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By Kristi King (Apr 13, 2017)
As the region slides into spring, it’s time to take a look at what’s really in your fridge and cupboards.
While it’s good to make sure you’re not using food that’s no longer palatable, most old food is not likely to make you sick.
“Food-poisoning bacteria don’t grow in the freezer. So, no matter how long a food is frozen, it will be safe to eat,” said Marianne Gravely, technical information specialist with the U.S. Department of Agriculture’s Meat and Poultry Hotline.
In the refrigerator, most foods that will spoil won’t make you sick, but according to Gravely, you still wouldn’t want to eat it.
“If you see mold or something slimy or there’s a bad smell, that’s a sign of spoilage,” Gravely said. “It probably won’t make you sick. But everyone’s different — you might have a more sensitive stomach.”
Bacteria that can make you sick can grow slowly in the refrigerator. Listeria monocytogenes is found in processed foods such as lunch meats, hot dogs, soft cheeses and prepared salads from the deli.
“If you’ve bought lunch meat from the deli, you want to use it within three to five days. Same thing with any kind of prepared salads,” Gravely said. “Soft cheeses, make sure they’re made with pasteurized milk.”
Gravely recommends paying special attention to “sell by” and “best by” dates for those items.
Dry goods will eventually go stale and lose flavor or maybe the favor will be odd.
“It’s certainly not going to be an enjoyable meal,” Gravely said.
To avoid wasting food, Gravely’s advice is to take everything out of the pantry, wipe down the shelves and organize items so that the oldest thing is up front.
The USDA has an app that gives advice about how long many foods will stay safe in different environments. And if you have any more questions, you can talk with someone through the USDA Meat and Poultry Hotline between 10 a.m. and 6 p.m. at 1-888-674-6854.

Trump's Mar-a-Lago club cited for serious food safety violations
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By Richard Luscombe (Apr 13, 2017)
Mar-a-Lago, Donald Trump’s exclusive Palm Beach country club where the US president has an increasing fondness for entertaining world leaders with dinner and diplomacy, has been cited for a number of serious food safety violations by Florida’s restaurant inspectors.
During a routine visit in January, just days before Trump hosted a now infamous meal on the terrace with the Japanese prime minister Shinzo Abe, inspectors found three “high priority” violations, including offering diners potentially parasitic raw fish and storing meat in broken coolers at too high a temperature.
Ten other noted violations, which include the presence of rusty shelves in a walk-in cooler and kitchen staff being unable to sanitise their hands properly because of an absence of hot water at sinks, were deemed less serious under Florida’s stringent food safety regulations, yet still damaging to the reputation of the upmarket club that charges a $200,000 initiation fee, and $14,000 a year for membership.
The multiple violations from the 26 January inspection visit are described in a recently published report on the Florida department of business and regulation’s website, and uncovered by the Miami Herald on Wednesday.
According to the report, almost all of the violations were immediately corrected. In the case of the refrigerators, in which poultry, duck, beef and ham were recorded at “potentially hazardous” temperatures up to 16F warmer than the required 41F maximum, Mar-a-Lago staff told the inspectors that one cooler had been incorrectly set to defrost, and called a technician to restore the correct temperature.
The inspectors also wrote that “nonexempt fish offered raw or undercooked has not undergone proper parasite destruction”. They stated the violation had been “corrected on-site” by kitchen staff either fully cooking or discarding the fish.
The more minor hygiene infractions included a food preparer not wearing a hairnet and another employee drinking from an open container in a food preparation area.
State inspectors concluded that Mar-a-Lago’s kitchen did meet minimum standards.
But the columnist Jose Lambiet, who wrote the Miami Herald report, told the Guardian in February that he had never been a fan of the catering at Mar-a-Lago. Trump entertained the Chinese premier, Xi Jinping, there last weekend, and will be spending the upcoming Easter break on his seventh visit “home” since his inauguration 11 weeks ago.
“The food is borderline cafeteria food,” Lambiet said. “The food I got at Mar-a-Lago over the years was sometimes embarrassing. At one point we had lamb, but it wasn’t lamb that you cut in slices and that melts in your mouth, it was like lamb over a bone. [They’re], like, in their tuxedos, eating bones with a little bit of lamb on it.
“You should never be able to go to a party at Mar-a-Lago with subpar food, and it happens a lot.”
Lambiet noted that the club had only two violations in 2015. The increase could be explained in part, he believes, because Trump as president no longer has the time to personally supervise his kitchen staff.
“He’s a hands-on guy, he goes in the kitchens, he goes and makes sure everyone’s served. He’s hands-on when it comes to this kind of business, when it comes to Mar-a-Lago,” Lambiet said.
Bernd Lembcke, Mar-a-Lago’s managing director, did not return the Guardian’s call seeking comment.

Food safety insecurity used as a hook against regulatory reform
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By DAN FLYNN (Apr 12, 2017)
Each side has just the congressional recess left to practice its hyperbole for the coming Senate fight over how regulations will be used across government. It’s going to get nasty. And confusing. The practice of giving the other side’s bill a dirty name is now a common tactic.
Since the Regulatory Accountability Act passed the House by a vote of 238-to-183 in January, the collection of consumer and environmental groups opposing the bill have taken to calling it the “Filthy Food Act.”
It’s far from certain, however, that the new Regulatory Accountability Act would translate  into  weakened federal food safety standards.  It is, after all, about how new regulations might be imposed, not about changes to any of the 47,661 rules put in place since 2001, including 1,062 “major new rules” that each cost the economy $100 million or more each year.
Since the 1970s, agencies have had to keep track of the costs and benefits of regulations and Government Accountability Office dutifully keeps track of all the data, which is a said to impose $2 trillion a year on the economy.
The new Regulatory Accounting Act would  put agencies through more hoops in the regulatory process.  More were added the 1980s, but it’s hard to say that slowed the process.   Congress likes leaving the details to the agencies.
The new Regulatory Accounting Act calls for more attention to the economic impact on small business, and calls for indirect and cumulative impacts of new regulation to be taken into account when new regulations are being proposed.
Agencies promulgating rules would be required to come up with alternatives to proposed rules to minimize any adverse economic impact or maximize any beneficially significant economic impact on small entities. The Bureau of Land Management (BLM) and the U.S. Forest Service, the agency landlords for most of the 640 million acres owned by the U.S. government,  are required to generate business –friendly alternatives in their own planning.
Current food safety rules were adopted after bipartisan approval of the Food Safety Modernization Act and a 5-year rule making process that FDA conducted with stakeholders, sometimes reversing directions to maintain consensus. Opponents of the Regulatory Accountability Act says the current food safety rules would not have survived “never-ending reviews and layers upon layers of wasteful Congressional and judicial red tape.”
However, there was Congressional involvement and judicial review, especially over deadline dates for the various rules.
Several consumer/environmental groups that are often involved in food safety issues have written several companies also often involved in food safety to persuade them to oppose the Regulatory Accountability Act when it comes to the Senate in May.
The “open letter” went out to Campbell Soup Company, Cargill, Coca-Cola, CVS Health, Domino’s Pizza, General Mills, PepsiCo, Target, Walmart, and Yum! Bands. “Food safety rules help reduce the risks posed by pathogens, additives, and pesticides,” says the letter. “But the “Filthy Food Act” passed by the House would create an unprecedented regulatory gauntlet through which no food safety rule or guidance could pass.”
Signing the letter were representatives of Food Policy Action, Food & Water Watch, Environmental Working Group, Consumers Union, Consumer Federation of America, and Center for Science in the Public Interest.
Putting aside whether the new law would truly be a “regulatory gauntlet” for regulations, some significant elements are included.  One would repeal the so-called “Chevron” doctrine, so named for a 1984 Supreme Court case of Chevron USA v. Natural Resources Defense Council Inc. that gave deference to agency legal interpretations when their decisions are challenged.
Also billion dollar rules would not take effect until timely filed litigation challenging their promulgation is resolved.  It also beefs up the existing prohibition on federal agency lobbying for their own rules.
The consumer/environmental groups claim the new Regulatory Accountability Act “would require officials at the U.S. Department of Agriculture, the Food and Drug Administration, and other agencies to seek out the least costly, and not the most beneficial, regulatory approach to food safety problems…”
“Manufacturers, retailers, and restaurants generally take food safety serious, which is why they should not stand by while their trade associations dismantle the food safety system,” said CSPI president Michael F. Jacobson. “Extremists like (White House chief strategist) Steve Bannon may sneer at what he calls the ‘administrative state,” but that’s generally what’s keeping E. coli, Salmonella, and Listeria out of our food supply.”
Jacobson is inviting the food companies “to work cooperatively with us to defeat this reckless and irresponsible piece of legislation.”

Northern Ireland’s FSA opens comment period on novel foods
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By NEWS DESK (Apr 11, 2017)
Comments, that began on April 4, 2017 and continue to June 27, 2017, are being taken by the Food Standards Agency for Northern Ireland about enforcement of novel foods by food businesses.
The agency says its aim is to ensure effective, consistent and proportionate enforcement of the new novel foods regulations, known as (EU) 2015/2283. The updated rules take account of operational experience of the current legislation, technical and scientific advances; and changes in other areas of food law.
Who should have the most interest in this request for consultation?
Food businesses in Northern Ireland dealing in food/food ingredients or processes that do not have a significant history of use within the European Union prior to 15 May 1997. In particular food innovators such as those developing engineered nanotechnology for use in food. This consultation will interest novel food and entomophagy (insects for human consumption) based businesses and importers dealing with fresh produce from third countries. It will also be of interest to district councils. The consultation may also be of interest to health professionals, consumer groups and others with an interest in food labelling legislation.
What is the subject of this consultation?
The Novel Foods Regulations (Northern Ireland) 2017 will repeal and replace the Novel Foods and Novel Food Ingredients Regulations (Northern Ireland) 2004 (S.R. 2004 No.33) and The Food Enzymes Regulations (Northern Ireland) 2009 (S.R. 2009 No.415). The proposed Regulations will enable the execution and enforcement in Northern Ireland of the Novel Food Regulation (EU) 2015/2283 (which amends Regulation (EU) No 1169/2011 and repeals Regulation (EC) No 258/97 and Commission Regulation (EC) No 1852/2001).
What is the purpose of this consultation?
To provide interested parties with an opportunity to comment on the draft Northern Ireland Regulations. Parallel regulations will be produced in England, Scotland and Wales and consultations on these will be issued in due course.
Where to send comments:
Seth Chanas
Division/Branch Finance, Business Support and Communications
Food Standards Agency
10a-c Clarendon Road
Telephone: 028 9041 7762
Responses are requested by: Tuesday, 27 June 2017
Summary of responses will be published
Within three months of a consultation ending we aim to publish a summary of responses received and provide a link to it from this page.
In accordance with the FSA principle of openness we shall keep a copy of the completed consultation and responses, to be made available to the public on request. The summary of responses may include personal data, such as your full name. Disclosure of any other personal data would be made only upon request for the full consultation responses. If you do not want this information to be released, please complete and return the Publication of Personal Data Form. Return of this form does not mean that we will treat your response to the consultation as confidential, just your personal data.

Two-year old Wyoming Food Freedom Act gets expanded
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BY DAN FLYNN (Apr 11, 2017)
The 2-year old Wyoming Food Freedom Act came in for a make-over this legislative session.
Rep. Tyler Lindholm, R-Sundance, sponsored the major legislation to “extend and clarify” the Food Freedom law.  Gov. Matt Mead signed it into law.  Session ended March 3.
The 2015 law has been changed “to allow for a producer’s production and sale of homemade food or drink for an informed end consumer’s home consumption and to encourage the expansion of agricultural sales at farmers’ markets, ranches, farms and producers’ homes.”
According to the 33-year old Lindholm, the remake of the Wyoming Food Freedom Act includes these clarifications:
Amendments create definitions for “homemade,” “producer,” “process” and “this act.”
Homemade food products are specifically exempt from state licensure, permitting, inspection, packaging, and labeling requirements.
Meat products and animals that may be sold under the act are identified.
Farmers markets, farms, ranches, producer home and offices are all named as places where transaction may occur.
Permitting state agencies, upon request, to provide assistance, consultation and inspection services.
Rabbit and fish were added as products consumers can purchase directly from producers, and Wyoming adopted a one thousand bird exemption that is modeled after a federal regulation permitting the butcher and annual sale of  up to one thousand chickens directly to consumers.
This session’s Food Freedom additions are occurring because the act has proven to be “a homerun,” according to Linholm. He’s says people are not getting sick from homemade foods, but are becoming more dependent on what he calls “local food hubs and sources.”
Another change, going into effect on July 1 in the Cowboy State, will allow commercial sellers to sell inspected and uninspected foods side-by-side as long there is a separate cash register and barrier provided.
Lindholm is a married rancher with four children. He was elected to the Wyoming House of Representatives without opposition in the 2014 general election.
Nothing in the Wyoming Food Freedom Act precludes the state department of health from investigating outbreaks of food borne  illnesses, nor does it in anyway impacts state brand inspections.

Beef Checkoff Launches Food Waste Challenge
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By (Apr 10, 2017)
In recognition of Earth Day on April 22, the Beef Checkoff is challenging consumers to #WasteLess with our 30 Day Food Waste Challenge. Although beef is one of the least wasted commodities produced in the U.S., at around 20 percent of edible product going to waste, consumers could help improve beef sustainability by 10 percent simply cutting that waste in half.  The challenge encourages Americans to raise awareness and introduce simple changes to fight food waste in their daily routine. People who sign up for the Food Waste Challenge will be given shopping tips and food prep strategies to help reduce food waste in their households. They are also encouraged to post on social media using #WasteLess to encourage others to join the challenge.
Food waste is a continuing problem in the U.S. According to World Food Day, 30 to 40 percent of the food supply in North America is wasted. Reducing food waste is one of the most impactful steps anyone can take to reduce their impact on the environment. Food that doesn't get eaten not only wastes the resources used to produce it, but ends up in a solid waste landfill, the number one source of methane emissions in the U.S. Additionally, the beef checkoff's 2015 Sustainability Executive Summary states that food waste costs the average American family approximately $2,500 annually.
In 2016, the challenge's first year, more than 500 people participated. Most participants were graduates of the beef checkoff's Masters of Beef Advocacy (MBA) program. This group of beef and dairy producers, along with chefs, teachers, doctors, dietitians and others in the beef community is leading the way in advocating for agriculture and environmental sustainability. This year's challenge aims to reach beyond MBA graduates and make a bigger impact on reducing food waste across the country.
Not only are cattle producers reducing food waste in their homes, they are doing their part on the farm too. Through better management of cattle nutrition, farmers are able to take byproduct common in their region, such as almond hulls, beet tops and potato starch, and feed that to cattle instead of letting it go to waste.
Beef is an ideal ingredient to help combat food waste because it is great for batch cooking, can be used in a variety of dishes, and stores well both raw and cooked in the refrigerator and freezer when handled properly. The beef industry is making great strides in minimizing its impact to the environment and hopes that this 30-Day Food Waste Challenge will encourage American's to join that effort.
The Beef Checkoff Program was established as part of the 1985 Farm Bill. The checkoff assesses $1 per head on the sale of live domestic and imported cattle, in addition to a comparable assessment on imported beef and beef products. States may retain up to 50 cents on the dollar and forward the other 50 cents per head to the Cattlemen's Beef Promotion and Research Board, which administers the national checkoff program, subject to USDA approval.

Pride and Joy Creamery again filling retail orders for raw milk
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By DAN FLYNN (Apr 10, 2017)
Pride & Joy Creamery was back to bottling its organic grass-fed raw milk on or about  April 4 after the Toppenish, WA dairy handled the scare resulting from E. coli being found in its plastic jugs collected from retail shelves.
“We want to assure everyone that no one has been sick from drinking our milk,” said Allen and Cheryl Voortman and Ricky and Cindy Umipig, co-owners of the business officially named Pride & Joy Puget Sound, LLC.
In their letter to customers, they said: “The only time a problem showed up was at the WSDA lab,” referring to the Washington State Department of Agriculture. Pride and Joy sent samples taken on its own to WSU labs in Puyallup and to Silliker, Inc a Mérieux NutriSciences company, in California.
The owners said those samples sent to outside labs all “came up clean.” It then enlisted the lawyers at the Farm-to-Consumer Legal Defense Fund, which sent WSDA a letter on March 22nd claiming the positive test results does not mean the raw milk was adulteration under Washington law.
The Falls Church, VA-based law shop argued the WSDA test did not prove the shiga toxin was actually in the raw milk.
WSDA is responsible for regulating 465 licensed dairies, 124 milk processing plants, and 39 retail raw milk operations. “We inspect all of them, though retail raw milk inspections also involve additional testing for pathogens since they are not pasteurized,” said WSDA spokesman Hector Castro.
As for WSDA labs, Castro says collection and sampling protocols are extensive and closely followed. It meets global standards for testing and calibration, and is accredited and used extensively by FDA for food outbreak investigations in the Pacific Northwest.
Pride & Joy Creamery invited WSDA inspectors back and 12 additional samples were collected for the lab. All of those came back clean and the state green-lighted the dairy to resume operations.
The incident was definitely costly for the dairy. It recalled all its production from Feb. 10 to Feb. 24 after the E. coli contamination was found in plastic jugs on retail shelves. At the time the E. coli showed up, WSDA was investigating Samonella infections in two people who reported drinking Pride & Joy raw milk before becoming ill.
At that time Cheryl Voortman claimed the contamination was caused by others in the supply chain or state inspectors.
However, before it resumed operations, Pride & Joy also engaged a third-party sanitation specialist and an attending veterinarian to help them “develop a herd health action plan,” Casto told Food Safety News. “We confirmed that certain remediation efforts were taken to address sanitation concerns and one of our vets is working with the attending veterinarian to finalize their herd health plan,” he said.
In its letter to customers, Pride & Joy said it will work over the next week and half to get everyone back in stock. It will start by fulfilling orders with drop off groups that  already paid the week it shut down, and then getting back on store shelves.
“We didn’t want to stress out the cows while all of this was happening , so we didn’t tell them was was going on,” they told customers.
The Pride & Joy owners thanked those who supported them “spiritually, financially and through the power of numbers defending us to the WSDA, and writing letters to our State Representatives. We cannot stress enough to you much it means to see the passion you have for our product.”
At the time they removed their product from the market, Pride & Joy was fetching $10 per gallon for raw milk sold over the internet and $13 per gallon at retail stores.
Editor’s Note: Food Safety News Managing Editor Coral Beach  contributed significantly  to this story.

Are you making your family sick? Food safety tips for the home
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By  (Apr 10, 2017)
As summer approaches, families everywhere are breaking out of their winter food rut in time for picnics, barbecues and pot lucks. Unfortunately, as we take that food on the road, it may be carrying some unwelcome passengers it picked up in your kitchen.
To help you avoid those food-borne illnesses with symptoms you can’t talk about in polite company, Millie Olsen, registered sanitarian with the City-County Health Department in Great Falls, took a moment to share some tips on food safety in the home.
Olsen monitors businesses to make sure they are practicing proper food safety procedures, but many of those same procedures can be practiced at home.
Temp targets
The food temperature danger zone is between 40 and 140 degrees—that’s the range where bacteria can grow and multiply.
“When you’re cooking things, you want to get above that 140 as quickly as possible,” said Olsen, “and when you’re cooling things down, you want to get below that 40 degrees as quickly as possible.”
Olsen busted the myth that putting hot food directly into the refrigerator is unsafe. Your fridge might have to work a little harder for a while, but that’s it.
“As long as your refrigerator is running properly and you’re not putting gallons and gallons of hot soup into your fridge at the same time, it should work just how it was designed to,” Olsen said.
Dividing large recipes or leftovers into portions in separate containers will help get things down to that 40 degrees faster.
If you’re thawing frozen food or marinating, don’t leave it on the counter. Use the fridge, cold water or the microwave for defrosting and put marinating items in the fridge.
Think that burger is done just because it’s no longer pink? Sorry. When heating or cooking food, only a food thermometer can tell you when it’s OK to consume.
“A lot of people will use their food thermometer maybe for their turkey once a year or for a roast,” said Olsen, “but especially for your chickens and your burgers, you want to get to those target temperatures—165 for your chicken or 155 for your burgers—so that you don’t make yourself sick.”
Double check your microwaved and grilled foods, as well. Both can cook unevenly or leave cold pockets where bacteria can grow. Use a thermometer in several spots and stir foods when reheating.
Food handling
“It’s not so much the foods themselves that cause the illness,” said Olsen. “It’s improper cooking or cross-contamination with those foods. So you want to make sure when you’re working with any of your animal proteins that you’re preventing that cross-contamination by only using one cutting board for your proteins and not then using it with something that you’re going to eat without cooking, like your salads.”
If you’re re-using cutting boards or knives while cooking before they go into the dishwasher, wash thoroughly with hot water and dish soap to remove bacteria. A rinse won’t do.
Cross contamination can happen in the refrigerator or even in the grocery cart at the store, so keep proteins separate and clean the fridge often. Don’t use marinades that held raw meat unless they are boiled first.
And speaking of the store, those little misting waterfalls in the produce aisle don’t wash off bacteria. Wash all produce in clean water that’s as warm as possible. Even items with rinds such as melons or oranges should be washed because a knife can transfer bacteria into the part you eat the fruit is cut.
Produce might need a little bath before you eat it, but the same doesn’t hold true for meats.
“One of the things that’s my pet peeve is people rinsing their chicken or raw meats in the sink,” said Olsen. “You don’t need to rinse it. That’s not going to do anything to help get rid of any harmful bacteria, you know, you have to cook to that proper temperature. And you’re actually spreading (bacteria) by aerosolizing those little droplets and spreading salmonella all over your kitchen by rinsing your chicken.”
Hand washing
Everybody washes their hands after they use the restroom, right? Even at home when there’s no one looking?
Hand washing in the kitchen is especially important. Kitchen surfaces, your phone, your kids, your dog and your own body hold bacteria that can transfer to the foods you cook.
Proper hand washing means using soap and the warmest water possible, scrubbing the backs of your hands, between your fingers, and under your nails for at least 20 seconds (think about singing the Happy Birthday song twice through).
Picnics, barbecues and buffet-style meals
We’ve all had those lazy family meals where food sits out and people pick on it all day long. Unfortunately, food isn’t the only thing you could pick up when you do this.
“A good rule of thumb is you don’t want to have something sitting out on the counter for more than two hours,” said Olsen, “and for a picnic you don’t want it out for more than one hour if it’s 90 degrees or hotter outside.”
If food needs to be out longer, cover it and use warming dishes or a slow cooker to keep it hot and ice or coolers to keep it cold. Bowls should be nested into the ice and food stirred often to keep it cold throughout.
Even though you’ve already cooked it once, leftover food still needs to adhere to the 40 to 140 rule for temperature.
Use leftovers within 2-3 days—a week at the most. If you don’t think you’re going to eat them, put them in the freezer. If you’re cleaning out the fridge and don’t know how old something is, throw it out.
Expiration dates
“Expiration dates for anything except for infant formula are actually not about food safety, it’s more about food quality…so you can use food safely past the expiration date,” Olsen said.
That doesn’t mean you should stockpile food and keep it for years and years. Acidic items such as tomatoes can break down the can they’re in, so try to only buy what you’re going to use in the near future.
As far as milk goes, “The rule of thumb would be, when you open it, use it within a week,” Olsen said, “And then, obviously, if you wait to open it and then it smells funny or it’s weeks past that sell by date, then if in doubt, throw it out.”
While many food-borne illnesses are not life-threatening, even the smallest dose of botulinum toxin can be fatal. People mostly contract botulism through home-canned foods that are canned improperly, especially green beans and tomatoes.
Don’t get home-canned foods from people you don’t know and trust. Jams and jellies from farmers markets should be OK because of the high sugar and acid content, but people are not legally able to sell other canned goods without a proper license. If a store-bought can is bulging, throw it away.

Pre-Analytical Sample Preparation in Food Microbiology: An Overview
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By Byron Brehm-Stecher, Ph.D
The foods we eat are extraordinarily complex in terms of texture, granularity and biochemical and microbial composition. At the microscale, our foods provide a bonanza of physical and nutritional niches that can be exploited by various microorganisms, including human pathogens. Physical manipulations commonly used in food preparation, such as slicing, chopping, grating and grinding, both release nutrients and provide additional colonizable surface area.[1] Things get even more complicated when we consider that a typical recipe combines different ingredients from multiple plant and/or animal sources, each with its own capacity to support microbial growth and its own intrinsic microbial content, which could be classed as either “normal” flora or contaminants. This complexity of foods presents challenges to microbiologists, whose job it is not only to control the growth of spoilage and pathogenic microbes but also to screen for and detect specific organisms, should they be present.
Some foods, such as raw poultry, are more likely than others to host bacterial pathogens, including Salmonella and Campylobacter, sometimes at relatively high levels.[2] Other foods may contain only trace levels of these or other pathogens, if at all. The rare and/or sporadic nature of such contamination makes these organisms difficult to detect, a problem that may be further compounded by low infectious doses for some pathogens: as few as 10 CFU for Escherichia coli O157:H7, 500–800 CFU for Campylobacter or 10–100 virions for norovirus.[3] Apart from bulk sample volume, properties of foods that can complicate (or thwart) successful detection of target pathogens, especially at low levels, include the presence of particulate matter, high viscosity, formation of macromolecular networks upon addition of water, opacity or coloration, high fat content, high loads of background microflora, heterogeneous distribution of target organisms and, in some foods (e.g., alfalfa sprouts), biofilms.
Pathogen Detection — From Soup to Nuts
Successful detection of pathogens in foods involves the seamless integration of three interdependent steps: 1) statistically validated sampling, 2) pre-analytical sample preparation (the physical, chemical and/or enzymatic manipulations needed to address the issues and limitations posed by complex food matrices) and 3) detection (Figure 1). Weak links in any of these steps will propagate through the system and degrade the end result and, in a worst-case scenario, lead to false-negative results. “Upstream” methods for sampling have long been established,[4] and the past 25 years or so have seen a revolution in development of the hardware and reagents needed for truly rapid detection of pathogens. However, even the most sophisticated detection methods cannot reach their full potential without next-level advancements in pre-analytical sample preparation, which is the key bottleneck in getting from sample to answer when detecting pathogens in foods.[5]
Feeding the Need for Funding
With these challenges in mind, the food microbiology research community has focused intently in recent years on unstopping the sample prep bottleneck, spurred on by private funding from the food industry and federal funding from agencies such as the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA). For example, over the past few years, requests for proposals for USDA’s Agriculture and Food Research Initiative Competitive Grants Program have routinely encouraged submissions focused on development and validation of “novel concentration and purification methods for the rapid, low-cost and efficient isolation or capture of viable infectious human pathogens from foods or environmental samples relevant to food production,” with special preference given for methods applicable to multiple matrices and pathogens. In 2014, FDA posed a nontraditional, $500,000 open challenge to “scientists, academics, entrepreneurs and innovators from all disciplines” to submit concepts aimed, in part, at accelerating or eliminating sample prep for detection of Salmonella in fresh produce.[6] This FDA Food Safety Challenge received submissions from 49 teams, and five finalists were awarded $20,000 each to further their concepts. Ultimately, one university-led team and one private company were selected to share the remaining $400,000 in prize money. These financial incentives and support for development of sample prep methods simultaneously acknowledge the importance of the problem and help facilitate work toward development of solutions that can benefit the food industry and regulatory agencies and, ultimately, improve public health.
Basic Categories of Sample Prep
Pre-analytical sample prep methods can be broadly organized under several basic categories, reflecting whether they are targeted toward specific organisms and the fundamental mechanism(s) behind their operation. An overarching distinction between different types of sample prep methods is whether the method is non-specific or specific in nature. Non-specific methods can be thought of as “catch-all” or “brute force” in nature and include methods used to capture and/or concentrate a wide range of microbes (and sometimes co-concentrate particulate matter) in a sample. Non-specific methods may be used to make a “first cut” that prepares the sample for additional downstream manipulations. Examples include “pull-down” methods used to precipitate bacteria or viruses from large volumes of liquid, such as the use of flocculents to precipitate bacteria or granular activated carbon for adsorptive recovery of viruses from large volumes of water.[5, 7] Other non-specific approaches include the use of cationic magnetic beads or metal hydroxide particles for charge-based capture of microbial cells, which carry an overall negative surface charge, and centrifugation, the size selectivity of which can be modulated by speed, duration and the use of density-gradient media. The simplest use of centrifugation as a sample prep step is the use of slow, short spins to cause sedimentation of large food particles, such as alfalfa sprout debris, leaving bacterial cells in suspension for analysis.[8] Continuous-flow centrifugation, a variant technique capable of handling larger volumes than typical “batch” centrifuges, has also been used for concentration of Bacillus and Clostridium spores from milk in support of homeland security efforts.[9] Specific methods are those targeting particular cell types. These can still be relatively broad, such as with lectin-based approaches for selective capture of Gram-negative bacteria, where concanavalin A binds to lipopolysaccharide residues in the Gram-negative outer membrane, or similarly, through use of the antibiotic vancomycin as a ligand for selective capture of Gram-positive bacteria. The level of specificity can be narrowed or “tuned” as desired through use of bioaffinity reagents having more restricted recognition spectra, as with the use of antibodies that bind specifically to antigens present only on the surfaces of certain cells, Salmonella spp. or S. Typhimurium, or through the use of phage tail fibers specific for E. coli O157:H7, for example.
Additional levels of distinction between different sample prep approaches can be made on a mechanistic basis—looking at how these methods accomplish their task. We can class methods used to capture and/or concentrate cells from a sample as physical methods if they do so through applying some physical force to the cells. Examples are varied and include methods ranging from filtration to centrifugation to even acoustic, magnetic or dielectrophoretic selection or concentration methods (application of sonic, magnetic or electrokinetic forces). Chemical (or enzymatic) methods are those applied to modify the structure of complex food matrices through chemical or enzymatic digestion. Examples include the “matrix lysis” approach used by Mayrl et al.[10] to chemically disintegrate various food matrices including fish, meat, ice cream and eggs, the use of proteinases for enzymatic digestion of chicken extracts or rinses[11] or use of ionic liquids to solubilize foods for extraction of bacteria.[12]
In practice, many sample prep techniques can be most accurately classified as combination methods, as they combine both physical and chemical or enzymatic approaches. For example, in the matrix lysis technique, chemical treatment is first used to degrade the food matrix and release bacterial cells, which are then collected via physical means. Similarly, Vibbert et al.[11] used enzymatic pretreatment of chicken extracts and rinses to enhance the efficacy of cell collection using microfiltration (a physical method). Other combination approaches include a method for physicochemical extraction of bacteria from homogenized eggs. In this method, egg samples are mixed briefly (30 seconds) with oleic and caprylic acids, which react with and break up the egg matrix, forming water as a byproduct; as with matrix lysis, released bacteria are then harvested via centrifugation.[13] Similar “treat and spin” approaches have been described for milk, using either enzymatic[14] or chemical[15] approaches.
Especially with commercial sample prep products that are available as kits, there may be a tendency for end-users to adopt a “kittology” mindset, where an approach is blithely applied as a formulaic “black box.”[16] Categorization of sample prep methods as described above can be a useful exercise for focusing the end-user’s mind on the processes behind each technique and on considering what stresses and forces may be exerted on food microbiota. This, in turn, can help reveal potential limitations or pitfalls of a given method and shed light on how these might affect the result, or whether it is even appropriate for a given food-pathogen pairing.
Finally, microbiologists must decide whether they are interested in capturing, concentrating and analyzing whole cells (or virions) or cellular components such as nucleic acids, which can be extracted directly from complex food matrices for culture-independent analyses. Because the broadest range of analytical possibility is available when starting with intact and viable cells, this article will focus primarily on cell-focused sample prep methods (Figure 2[5]).
Dedicated Sample Preparation Equipment
Standard equipment used in food microbiology labs has evolved over the years, shaped and driven by the need for increased convenience, throughput and efficacy. It is fitting that some of the first sample prep equipment used in food analysis was adapted directly from the kitchen—the mortar and pestle, the blender, the sieve and cheesecloth, as prime examples. The expense of Waring blenders (currently about $2,000 to $3,000 for a scientific-grade blender) and the need for sterilization between experiments place substantial limitations on throughput and convenience, hence, the wide popularity of commercial instruments for sample homogenization that utilize presterilized and disposable plastic bags. Also, the ingenuity of individual researchers knows no bounds, resulting in clever do-it-yourself solutions engineered to assist with manually difficult tasks, such as the paint shaker-like instrument reported by Dickens et al.[17] for shaking turkey carcasses in support of rinse sampling.
Although some of these instruments have been around for so long that their use seems almost reflexive, as with any element in the sample-to-answer workflow, microbiologists still must give careful consideration to their appropriate use. For example, when enumerating surface bacteria on acidic fruits such as strawberries or tomatoes, methods that don’t decompartmentalize tissues and release acid may result in higher plate counts for acid-sensitive organisms. Additionally, high-speed blending is not only a recognized method for nonlethal, shear-based removal of flagella from organisms such as Salmonella,[18] but it can also lead to higher cell counts for bacteria having a streptococcal morphology, due to breakage of cell chains into smaller units.[19] Therefore, blending might not be appropriate for procedures that will subsequently rely on the presence of flagella or when analyzing samples where Streptococcus, Enterococcus or Leuconostoc spp. are expected. “Legacy” sample prep methods should not be discarded because they are older or simpler than newer approaches; Bai et al.20 found that sonication-based homogenization of orange juice samples reduced the yield of bacterium Candidatus Liberibacter asiaticus DNA by 86 percent compared with a mortar and pestle. This example highlights the fact that careful consideration of the purpose of an experimental procedure and of the cellular analyte(s) to be detected can often help guide the choice of the most appropriate sample prep techniques.
Specialized sample prep instrumentation available commercially or in development includes automatic nucleic acid preparation instruments, vacuum-based surface samplers and instruments for capture and concentration of select pathogens from recirculated food suspensions and to electrophoretically concentrate DNA from complex samples, including those containing large amounts of PCR (polymerase chain reaction) inhibitors, such as humic acids.[21] Weimer et al.[22] (finalists in the 2014 FDA Food Safety Challenge) developed a system that uses a fluidized bed of antibody-functionalized glass beads to capture select organisms in liquified food or environmental samples at processing rates exceeding 100 mL/minute. The dead-end filtration system described by Lim et al.[23] has been applied for collection and concentration of total coliforms and spiked E. coli O157:H7 from 50-L produce wash samples, with subsequent detection via electrochemiluminescent immunoassay. Continued development and commercialization of such specialty sample prep equipment will provide industry with microbial testing tools that are commensurate with their needs for high-throughput testing of large-volume food and environmental samples.  
Better Reagents, Better Results
Although we typically approach the idea of sample preparation from the perspective of the upstream physical and chemical manipulations needed to extract, separate and concentrate target cells or their components from foods, we can expand the use of the term to include the reagent choices made immediately prior to the detection step, which can effectively be considered as “last minute” or “just in time” sample prep. One example is in molecular diagnostics such as PCR, which is susceptible to biochemical inhibitors or may suffer from limitations due to degradation of target DNA. In addition to sample preparation actions for inhibitor removal that may be performed during template isolation (sequestration of polyphenolic compounds with polyvinylpyrrolidone, binding of inhibitory cell components with ion-exchange resins, etc.), PCR-optimizing choices can also be made at the level of reaction-mix composition: adjustment of magnesium concentration, addition of PCR enhancers such as betaine, dimethyl sulfoxide or formamide, or use of polymerases that are less prone to biochemical inhibition.[24] In many applications of PCR, the sample preparation mantra of “dilution is the solution” applies, meaning that if sufficient template DNA is present, inhibitors can simply be diluted out.[25]
However, in cases involving low template concentrations or degraded DNA, this is not a tenable approach. In criminal forensics, DNA evidence is sought from blood or other bodily fluids to make an arrest or prosecute a legal case,[24]  but these samples may contain inhibitors or be degraded (the latter being especially true if the sample has been exposed to the environment for some time, or for archival samples collected and stored prior to the advent of molecular diagnostics). In microbial forensics, where the “criminals” are the pathogens that we seek to track for epidemiological purposes (to trace the source and the route from environmental contamination to disease), similar issues of low template presence and/or DNA degradation may also be in play.[26] In such situations, it may be possible to borrow lessons learned from parallel fields, such as criminal forensics or the study of ancient DNA. These may take the form of data handling and analysis procedures or novel reagent choices (e.g., alternate DNA polymerases).[24, 25, 27, 28] In this latter category, several naturally occurring Y-family polymerases or chimeric enzymes were examined for their abilities to amplify damaged DNA, with three found to have acceptable processivity and abilities to replicate past lesions typical of damaged DNA, including abasic sites and various dimers and adducts.[28] Alternatively, a combinatorial approach using molecular breeding (directed molecular evolution through gene shuffling) has been used to generate novel polymerases based on genes from various Thermus spp. that can replicate past DNA lesions and outperformed standard Taq polymerase by up to 150 percent with 47,000–60,000-year-old cave bear DNA and also yielded product at dilutions where Taq did not.[27] These approaches highlight the potential for making experiment-optimizing “last minute” or “just in time” sample preparation choices at points as late as the reagent choice step: immediately prior to obtaining a diagnostic output. As described here, such choices may include the use of novel polymerases capable of replicating past DNA lesions commonly encountered in ancient DNA, or in contemporary but damaged DNA exposed to the vagaries of the environment. Lessons learned from the allied fields of ancient molecular diagnostics or criminal forensics might therefore have direct applications to improving diagnostic results in food microbiology.
Unanswered Questions
Low-moisture foods once thought to be intrinsically safe, such as peanut butter and flour, are now recognized as potential vectors for foodborne disease. There is intense interest in understanding the physiological stresses resulting from exposure to such hostile environments and in the adaptations that enable pathogens such as Salmonella and E. coli to survive in these foods and cause disease. Additional work is needed to determine the practical impact of food or food processing environments on our abilities to capture and concentrate pathogens using current sample prep approaches. Gross changes in the physiology and corresponding biomolecular content of cells that have been exposed to environmental stressors could potentially render current sample prep methods less effective. For example, expression of bacterial flagella can be modulated by nutritional or environmental conditions such as the presence or absence of certain amino acids or temperature. If prevailing environmental conditions result in a down-shift in expression of flagella, then how effective will a sample prep technique be under these conditions if that approach relies on capture of target bacteria using antiflagellar antibodies? If cells respond to stress by forming filaments, how will this impact our ability to make effective use of filters with pore sizes targeted toward capture of smaller cells? Could environmental conditions induce physiological responses that impact microbial surface properties such as hydrophobicity and surface charge? If so, how would such changes impact our ability to extract these cells using ionic solvents, two-phase aqueous polymer solutions or adsorptive processes such as cationic beads or hydroxyapatite? In the past, the practice of relying solely on lab strains grown under standard conditions for development and validation of detection methods was considered both a necessity and a liability; standard conditions are needed to ensure experimental and interlaboratory reproducibility, but questions remain regarding how these methods may perform on bacteria living under “natural” or nonstandard conditions. We face an identical dilemma in the development of sample prep approaches, necessitating the evaluation of new or established methods using cells whose physiological condition more closely resembles that of naturally occurring contaminants, as opposed to happy, healthy and domesticated lab strains.
This article was intended to provide a broad overview of concepts and concerns regarding the burgeoning field of pre-analytical sample preparation in food microbiology. Although space precludes a comprehensive review of the topic, hopefully readers will come away with some new information or food for thought regarding this topic that is so fundamentally important to our work as food safety professionals. 
Byron Brehm-Stecher, Ph.D., heads the Brehm-Stecher Rapid Microbial Detection and Control Laboratory in the department of food science and human nutrition at Iowa State University.
1. Jay, J. 2005. Part III: Microorganisms in Foods, 7th ed. (New York: Springer).
2. McEntire, J et al. 2014. “The Public Health Value of Reducing Salmonella Levels in Raw Meat and Poultry.” Food Prot Trends 34:386–392.
3. Grieg, JD et al. 2010. “Infective Doses and Pathogen Carriage,” Food Safety Education Conference, Atlanta, GA.
4. ICMSF. 1986. Microorganisms in Foods 2, Sampling for Microbiological Analysis: Principles and Specific Applications, 2nd ed. (Toronto: University of Toronto Press).
5. Brehm-Stecher, B et al. 2009. “Sample Preparation: The Forgotten Beginning.” J Food Prot 72:1774–1789.
7. Cormier, J et al. 2014. “Concentration of Enteric Virus Indicator from Seawater Using Granular Activated Carbon.” J Virol Methods 196:212–218.
8. Johnston, LM et al. 2005. “A Simple Method for the Direct Detection of Salmonella and Escherichia coli O157:H7 from Raw Alfalfa Sprouts and Spent Irrigation Water using PCR.” J Food Prot 68:2256–2263.
9. Agoston, R et al. 2009. “Rapid Concentration of Bacillus and Clostridium Spores from Large Volumes of Milk, using Continuous Flow Centrifugation.” J Food Prot 72:666–668.
10. Mayrl, E et al. 2009. “Broad Range Evaluation of the Matrix Solubilization (Matrix Lysis) Strategy for Direct Enumeration of Foodborne Pathogens by Nucleic Acids Technologies.” J Food Prot 72:1225–1233.
11. Vibbert, HB et al. 2015. “Accelerating Sample Preparation through Enzyme-Assisted Microfiltration of Salmonella in Chicken Extract.” Biotechnol Prog 31:1551–1562.
12. Mester, P et al. 2010. “Use of Ionic Liquid-Based Extraction for Recovery of Salmonella Typhimurium and Listeria monocytogenes from Food Matrices.” J Food Prot 73:680–687.
13. Seo, KH et al. 2003. “Simple and Rapid Methods for Detecting Salmonella Enteritidis in Raw Eggs.” Int J Food Microbiol 87:139–144.
14. Gunasekera, TS et al. 2000. “A Flow Cytometry Method for Rapid Detection and Enumeration of Total Bacteria in Milk.” Appl Environ Microbiol 66:1228–1232.
15. Pahuski, EE et al. Methods and kits for separation, concentration and analysis of cells. U.S. Patent 5700645 filed June 7, 1995, issued December 23, 1997.
16. Kevan, PG and JT Trevors. 2001. “Formula Thinking, Formula Science and Kits.” J Microbiol Methods 46:85–86.
17. Dickens, JA et al. 1986. “Evaluation of a Mechanical Shaker for Microbiological Rinse Sampling of Turkey Carcasses.” Poultry Sci 65:1100–1102.
18. Stocker, BA and JC Campbell. 1959. “The Effect of Non-Lethal Deflagellation on Bacterial Motility and Observations on Flagellar Regeneration.” J Gen Microbiol 20:670–685.
19. Shapiro, SK and WB Sarles. 1949. “Microorganisms in the Intestinal Tract of Normal Chickens.” J Bacteriol 58:531–544.
20. Bai, J et al. 2013. “Extraction of DNA from Orange Juice, and Detection of Bacterium Candidatus Liberibacter asiaticus by Real-Time PCR.” J Agric Food Chem 61:9339–9346.
21. Brehm-Stecher, B. 2014. “Sample Collection and Preparation for Sensor-Based Detection of Pathogens in Food,” in High Throughput Screening for Food Safety Assessment, eds. Bhunia, AK, CR Taitt and MS Kim (Cambridge, UK: Woodhead Publishing), 11–22.
22. Weimer, BC et al. 2001. “Solid-Phase Capture of Proteins, Spores, and Bacteria.” Appl Environ Microbiol 67:1300–1307.
23. Magaña, S et al. 2013. “Automated Dead-End Ultrafiltration for Concentration and Recovery of Total Coliform Bacteria and Laboratory-Spiked Escherichia coli O157:H7 from 50-Liter Produce Washes to Enhance Detection by an Electrochemiluminescence Immunoassay.” J Food Prot 76:1152–1160.
24. Hedman, J et al. 2009. “Improved Forensic DNA Analysis through the Use of Alternative DNA Polymerases and Statistical Modeling of DNA Profiles.” Biotechniques 47:951–958.
25. King, C et al. 2009. “A Quantitative Approach to Detect and Overcome PCR Inhibition in Ancient DNA Extracts. Biotechniques 47:941–949.
26. Foley, SL et al. 2009. “Molecular Typing Methodologies for Microbial Source Tracking and Epidemiological Investigations of Gram-Negative Bacterial Foodborne Pathogens.” Infect Genet Evol 9:430–440.
27. d’Abbadie, M et al. 2007. “Molecular Breeding of Polymerases for Amplification of Ancient DNA.” Nat Biotechnol 25:939–943.
28. McDonald, JP et al. 2006. “Novel Thermostable Y-Family Polymerases: Applications for the PCR Amplification of Damaged or Ancient DNAs.” Nucleic Acids Res 34:1102–1111.

Tips on Handling an FDA Audit
Source :
By Bryan Armentrout (Apr 7, 2017)
Here’s a typical scenario.
You are the QA Manager for a dairy manufacturing facility in the Midwest. It’s been a long week and you decide to come in a little earlier than normal to catch up on paperwork. You find out when you arrive that product is on hold because the filling line is down. Maintenance is all over the machines, and orders are piling up; the paperwork will have to wait. You head out to the line to see what you can do to help.
This only happens when the plant manager is on vacation, you think to yourself.
As you walk out to the floor, your ears perk up as you hear your name paged over the intercom. The receptionist needs you in the front office—immediately.
What now?
You can’t think of anyone who is scheduled to visit today. You heart sinks a little. You don’t like surprises and this could be a bad one.
You come around the corner to the lobby to see exactly who you were hoping you wouldn’t see: An FDA investigator.
“My name is Investigator Brown,” he says as he flashes a badge. “We’ve had an allegation of an illness from your product. I am here to look into it.”
You smile politely and nod. He does not smile. You motion for him to follow you to a conference room.
Your day just got a whole lot longer.
How will this go?
The answer to that question is, in many ways, up to you.
FDA investigators are people and they take their job as seriously as you do. They are there because they need answers. Their boss expects answers. If people are getting sick, they need to find out quickly and take action. If this is truly the case, you need to know as well. So does your boss. No one wants people to get sick.
The absolute wrong thing to do in this situation is to not have a plan. You need to know how to handle a regulatory inspection. You need a plan to prevent a misunderstanding or create a situation where something minor gets blown out of proportion.
This is not the time to play it by ear. You need training and you need a plan.
An important point to remember is that your product may not have caused the illness. People often assume the last food they ate is the one that made them sick. In reality, incubation times may take significantly longer for symptoms to manifest. Samples of the product in question are rarely available to test. Dosage, health of the person, and other factors also come into play. You need to work with facts and not supposition—as does the FDA.
Tips for an FDA Inspection
You are guilty until proven innocent
You are not alone
You are the company spokesperson
Take lots of notes
Seek first to understand, then to be understood
Answer the question being asked
Know what is in scope and what is out of scope
Don’t sign or initial anything
1. You are guilty until proven innocent
In general, you can assume that FDA thinks you are at fault; that is why they are there. You will have a hole to dig yourself out of before you can convince them otherwise. Don’t let that rattle you, they are only doing their job, and your job is to show them all the great food safety programs you have in place to prevent what they are concerned about. Keep this in mind as you go through the visit. If you are doing a good job, you should see their demeanor soften as they gain confidence in what you do.
2. You are not alone
Don’t be a hero, you need a team to help you in this situation. You need the people in the plant and you need people at corporate ready to back you up. You most likely also need access to outside counsel that specializes in food regulations. Your role in the room is to facilitate and work with FDA to get them what they need. You and FDA are on the same side of the table in this respect. Both of you are working to find out if the illness is real.
If you are not sure of an answer, say so! Call corporate QA and your legal counsel and discuss it. Find out what the answer is from someone who does know. If you still don’t have an answer, it’s better to admit it than to make something up. Tell them when they can expect an answer, even if it may be after the audit concludes. Never make stuff up.
3. You are the company spokesperson
The company should have only one voice (most likely, you) responding during the inspection. This avoids confusion and keeps you in control over the message being delivered. Other agencies, such as OSHA, have the right under the law to interview employees during an investigation. It is not that clear cut with FDA. Make sure you explain to FDA that you are the designated spokesperson for this inspection and that all questions need to be routed through you. The personnel in the facility need to understand this as well and defer to you if FDA questions them. If the question is out of the ordinary, it may need to be in writing. When on the floor, never leave the investigator alone, accompany them at all times (don’t go crazy, they can use the bathroom by themselves).
4. Take lots of notes
Have someone who can tag along with you to take written notes of the visit. Train them on what you expect. Time stamp the notes and use a stream of consciousness approach. Write down everything, more notes are preferred. You may need them in the future. Never take the notes yourself, you are going to be too busy to do that. Mark the notes confidential and do not give a copy to FDA. Also, make sure that you have a clear and explicit ‘no photography’ policy in place. Train your people and enforce it. FDA may want to take pictures and they will tell you that they have the right to do so. That is open to debate and the issue has yet to be resolved in court. In the meantime, your policy is clear, so insist that they do not take pictures. This is your plant and your proprietary process; even with the best care, your competitors might find out more than they should about what you do.
5. Seek First to Understand, then to be Understood
This rule applies everywhere in life, and especially during an FDA inspection. Gather all the information you can. Are they going to take samples? If so, you need to prepare for that. Ask for the purpose of the visit and any supporting information you can get. Seek to first meet the needs to the investigator and to understand the exact context of the inquiry. The better you understand the purpose, the easier the day will be. Just like the investigator, you have a boss. You have limits to what you can and cannot do. Make sure the FDA understands that you are the representative, but the answer may need to come from other sources. Company policies are not written by you and cannot be altered. You are both on the same side of the table and rules need to be followed. They will understand and respect that.
6. Answer the question being asked
Once you understand the context and are asked a question, answer it; then shut up. The investigator has limited time to make his assessment. Answer the question directly and keep it to the point. Do not venture off into territory that is not relevant. Do not give excuses or jump to conclusions based on what they are asking. Don’t assume you know where the investigator is going with a line of questioning. If you are unclear, ask for clarification before answering. Once you have given your answer, stop talking, and wait for the next question.
7. Know What is in Scope and What is Out of Scope
With FSMA now in place, this tip is critically important. The FDA now has the legal authority to view all the documentation associated with your food safety plans, prerequisite programs, and preventive controls; this includes all the recording forms as well. You have to manage these very closely so everything is in order and documents are reviewed for compliance in the timeframes allowed.
Remember, FDA can now take your food safety documentation with them. Are they written so that they are clear and limits are communicated? The forms need to be able to speak without your presence as to what they are, whom they come from, and what they address. These documents may be used in a court case. Don’t confuse the issue by putting food safety and food quality information on the same forms.
Bottom line: You need to understand the law, your obligations, and FDA authority like an expert. The FDA is learning how to implement FSMA in the field, so you need to know when things go astray.
8. Don’t sign or initial anything
FDA will not sign anything, and neither should you. The only possible exception to this would be a receipt for a sample that was taken. Other than that, your signature or initial may be taken as an admission on your part. You are not authorized to sign or initial based on company policy. If corporate does not have this policy in place, put one in place now.
Your signature and initials as the PCQI will be on documentation attesting to the parameters measured. Make sure that these forms are clear and can stand on their own.
An FDA visit does not need to be overly stressful. If you are trained, have excellent systems and documentation, and a support team around you, things should go as planned. If you do get a Form 483 or warning letter, make sure that the mechanisms are in place to respond within the required timeframe. Every audit is different and needs to be handled according to the situation. This comes with experience, and the tips I have given here are based on real world experience in dealing with the FDA.
Any questions? Drop me a line at or comment on it below. I can provide general information, but cannot respond with specific answers for an actual investigation in the forum.






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