Tag Archives: FSMA

Top 6 Best Practices for Your Allergen Control Program

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Undeclared allergens are the cause of a great number of recalls in the United States, causing significant consumer health issues, scrap costs, and sourcing conundrums. Under FSMA, good manufacturing practices are undergoing revisions, and the one area that has gotten the most attention is allergen control.

Undeclared allergens were responsible for the greatest number of recalls in the United States in 2013, causing significant consumer health issues, scrap costs, and sourcing conundrums. Under the Food Safety Modernization Act (FSMA), good manufacturing practices (GMPs) are undergoing revisions — and the one area that has gotten the most attention is allergen control. Under the new GMPs, an emphasis has been put on facilities to have an allergen control program.

Further, 15 million Americans and 17 million Europeans have documented food allergies. According to a study released by the Centers for Disease Control and Prevention (CDC), food allergies have increased by 50 percent among children from 1997 to 2011; and hospital admissions for severe reactions have increased seven-fold in Europe over the past decade, according to the European Academy of Allergy and Clinical Immunology.

FSMA’s Proposed Rule for Preventive Controls for Human Food has two major features–provisions requiring hazard analysis and risk-based preventive controls, and revisions to the existing Current Good Manufacturing Practice (CGMP) requirements found in 21 CFR part 110. Included within these revisions is the requirement that each covered facility prepare and implement a written food safety plan, which includes a hazard analysis, preventive controls (e.g., process controls, food allergen controls, sanitation controls, and recall plan), monitoring procedures, corrective actions, verification activities, and recordkeeping.

Allergen Control Programs are multifaceted with elements ranging from ingredient supplier verification, storage, scheduling, formula and rework control, sanitation and changeovers, and label verification.

In essence, there are two main goals of an allergen control program, which appear simple on paper, but are very difficult to execute.

  • Goal #1: If you make a product with an allergen in it, you need to make sure that the allergen is declared on the label.
  • Goal #2: If you make a product that is NOT supposed to have a specific allergen in it, you need to do everything possible to prevent cross-contact.

So how can you make the most of your Allergen Control Program? Use these 6 Best Practices in this e-book, co-produced by TraceGains Inc. and AIB International. Click here to download.

FDA Seeks Key Investments for Implementing FSMA

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The agency makes a case for immediate investments now, and sustained funding in future years, explaining that there is a risk of delayed, uneven, and potentially disruptive implementation of FSMA, to the detriment of public health and the food industry.

The FDA Food Safety Modernization Act (FSMA) was signed into law in January 2011. FSMA reflects the need for a modern, global food safety system that prevents problems rather than primarily reacting to them after they have occurred.

The law, which received bipartisan support, followed a series of severe outbreaks of foodborne illness. It responds to the significant burden of foodborne illness in the United States each year, which the Centers for Disease Control and Prevention estimate at 48 million illnesses, 128,000 hospitalizations, and 3,000 deaths. The economic losses to industry, including farmers, are enormous, estimated at over $75 billion per year.

Since FSMA was enacted, FDA has carried out extensive work to implement the law by publishing key FSMA proposed rules that would provide needed food safety protections for the American public, while at the same time making the proposed rules as flexible as possible and workable.

These proposed rules were informed by current industry practices and by conducting extensive outreach and dialogue across the country and overseas with farmers, manufacturers, commercial food handlers, consumers, and government partners.

Currently, FDA is under court-ordered deadlines to issue all seven of these key final rules:

  • The final rules for preventive controls for human and animal foods are due on August 30, 2015;
  • The final rules on produce safety, Foreign Supplier Verification Programs, and accreditation of third party auditors are due on October 31, 2015; and
  • The final rules for sanitary transportation and intentional adulteration are due on March 31, 2016, and May 31, 2016, respectively.

Implementation

Developing reasonable, effective, and flexible rules is just the first step in FSMA implementation. Much more needs to be done to ensure smooth and effective implementation in late 2016 and 2017. And additional funding is needed to support the following areas:

  • Inspection modernization and training;
  • Furthering the National Integrated Food Safety System;
  • Education and technical assistance for industry;
  • Technical staffing and guidance development at FDA;
  • Building the new import safety system; and
  • Risk analytics and evaluation.

FDA is also committed to change within the agency itself to enhance industry compliance with the FSMA rules. First, FDA is overhauling its inspection model to fulfill FSMA’s prevention mandate. To carry out the new model, FDA will increase specialization of the inspection and compliance workforce, build a new compliance culture within FDA that uses a variety of tools and incentives to achieve compliance, and invest in training to ensure expert and consistent inspections and sound decision making.

Second, the agency will assume that most in industry want to comply with food safety standards and thus will educate before and while it regulates through guidance, education, and technical assistance.

Third, the frequency and manner of FDA’s inspections will be guided by a company’s food safety culture and performance.

The allocation of funds needed in FY 2016 to make these changes is outlined below.

FY 2016 plans for requested budget authority

With a total of $1.3 billion in budget authority, an increase of $109.5 million, requested in the President’s Budget, FDA will make improvements in the following areas, continuing improvements that began with FY 2015 funds.

1. Inspection Modernization and Training – $25 million

FSMA fundamentally changes FDA’s approach to food safety oversight, from primarily reacting to problems to preventing them in the first place. New inspection and compliance strategies will be a key component of this shift. FDA is not requesting more inspectors for domestic inspections, but rather will increase efficiency and effectiveness of current inspectors through the use of new inspectional models and approaches. Inspectors are currently trained to inspect food manufacturers using a compliance model focused on finding evidence of violations and bringing enforcement cases. The new food safety paradigm will be focused on whether firms are implementing systems that effectively prevent food contamination, requiring fundamentally different approaches to food safety inspection and compliance. For example, FDA will deploy more specialized inspectors, supported by technical experts, to assess the soundness and performance of a facility’s overall food safety system and will use data to guide risk-based inspection priority, frequency, depth, and approach. FDA will also focus on ensuring consistency among inspections conducted by FDA or the states on behalf of FDA.

This new paradigm involves a major reorientation and retraining of more than 2,000 FDA inspectors, compliance officers, and other staff involved in food safety activities. FDA has also committed to improving risk-based targeting, which will require better data about facilities, new IT systems to identify and track risk, and methods for assessing and tracking inspection efficiency and inspector competency.

2. National Integrated Food Safety System – $32 million

Congress recognized that the success of FSMA implementation depends on fundamentally new approaches to collaboration among the more than 3,000 state, local, and tribal government agencies involved in food safety. Building a National Integrated Food Safety System is a complex and long-term process. To be successful in aligning state programs with FDA’s new facility inspection and compliance approach, approximately 1,000 state inspectors will need training, and the states will need real-time information sharing capacity with FDA and other states, state laboratory accreditation, and inspector certification programs. Those processes, which will be carried out mostly via FDA grants and cooperative agreements to states, have been ongoing but must be ramped up significantly in 2016 to help ensure that states conduct sound, consistent inspections when industry must comply with the new preventive controls rules starting in late 2016. In addition, to successfully implement the produce safety rule, FDA must build state partnerships and capacity in 2016 to provide education and technical assistance to growers in anticipation of the rule starting to be implemented in 2017.

3. Education and Technical Assistance for Industry – $11.5 million

With FDA’s new approach to ensuring food safety, education and technical assistance are needed to help farmers, processors, and importers—especially small businesses—implement the new prevention-oriented standards. Approximately 300,000 entities could be subject to the final FSMA rules. FDA believes that it should expend substantial financial resources to provide such assistance and will make training materials widely available to protect public health. FDA would use a large portion of these resources to provide financial support to state agencies and public-private-academic collaborative entities, such as the Produce Safety Alliance and the Preventive Controls Alliance.

4. Technical Staffing and Guidance Development at FDA – $4 million

Maintaining an adequate number of highly qualified technical staff at FDA is always a priority and challenge, but FSMA makes it essential to achieve this goal. In addition to regulatory standards for FSMA, FDA is issuing guidance documents that express the agency’s current thinking and are essential to helping industry to comply with the FSMA requirements. Funds are needed now to recruit additional experts at FDA who can ensure that guidance development, which is now underway, is based on the best science and knowledge of industry practices. More experts are also needed to conduct outreach to industry, academia, and state extension services to ensure that their concerns are heard, that their advice is solicited and utilized, and that the guidance documents reflect the most cost-effective solutions achievable. They will also play an essential role in supporting FDA’s inspection and compliance force in properly overseeing implementation of the new standards and achieving high rates of compliance.

5. New Import Safety Systems – $25.5 million

Improving oversight of imported food is crucial to protect public health and ensure consumer confidence in food safety, regardless of whether food is produced domestically or imported. The food consumed by Americans today comes from over 200,000 different food facilities, more than half of which are located outside the United States. For example, about 50% of fresh fruits, 20% of fresh vegetables, and 80% of seafood consumed by Americans is imported. The volume of imported food has increased enormously over the past 20 years, going from fewer than 200,000 line-entries in the early 1990s to an estimated 12 million in 2013. The Foreign Supplier Verification Program (FSVP) mandated by FSMA, will require importers to implement supplier verification plans to help ensure food produced overseas meets U.S. food safety standards. This shift presents an enormous challenge for both FDA and food importers, given that there were approximately 88,000 consignees receiving food shipments last year. To be successful, FSVP implementation will require a substantial regulatory development process, training of more than 400 current FDA investigative and compliance personnel, and the addition of new staff (including 50 in 2016) with the audit skills needed to assess importer safety plans. It will also require extensive training and technical assistance for importers.

6. Risk Analytics and Evaluation – $4.5 million

Focusing decisions and resources on areas of greatest risk to health is a key element of FSMA, so FDA is developing new tools that will provide the information needed to do so. This includes new tools for ranking risks, prioritizing program activities based on opportunities to reduce risk, and linking risk-based priorities more clearly with budget formulation and execution. For example, these tools will better inform FDA about which foods, including animal foods, are most vulnerable to which bacterial contaminants, and where it should invest its research efforts to most effectively identify how to reduce contamination of food. This will improve FDA’s productivity in all areas, including research and standard setting, inspections, and guidance to industry.

Note: The $109.5 million increase in the food safety budget for FDA includes $7 million for necessary infrastructure costs.

Conclusion

Developing reasonable, effective, and flexible rules to create a modern, prevention-based food safety system is a formidable job, but it is just the first step in FSMA implementation. Much more needs to be done to lay the groundwork for smooth and effective implementation of FSMA in late 2016 and 2017. Without an immediate investment now, and sustained funding in future years, there is a risk of delayed, uneven, and potentially disruptive implementation of FSMA, to the detriment of public health and the food industry. 

Source: This article has been adapted from a paper authored by FDA, which can be accessed here. 

Lawmakers Introduce Bill for Single “Food Safety Administration”

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Food safety oversight is currently split up among 15 agencies in the Departments of Health and Human Services, Agriculture, and Commerce. The Safe Food Act of 2015 introduced in both houses of Congress on Wednesday, aims to consolidate all the authorities for food safety inspections, enforcement and labeling into the Food Safety Administration.

Senator Dick Durbin (D-IL) and Representative Rosa DeLauro (D-CT) introduced bills in Congress yesterday with a goal to establish a single, independent federal food safety agency. The aim is to improve food safety for consumers, while also cutting back on the costs of a dispersed system with overlapping responsibilities between agencies, according to Durbin.

 

“What the bill does is remedy the situation,” DeLauro said. “With a single agency, we believe our country will be able to have the ability to detect relatively minor problems before they become major outbreaks.”

The Act would provide the Food Safety Administration with mandatory recall authority for unsafe food, require risk assessments and preventive control plans to reduce adulteration, authorize enforcement actions to strengthen contaminant performance standards, improve foreign food import inspections, and require full food traceability to better identify sources of outbreaks.

DeLauro said the bill builds on the improvements made in FDA’s Food Safety Modernization Act (FSMA).

The federal agencies that would be incorporated into one include:

  • FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine (CVM); 
  • The resources and facilities of FDA’s Office of Regulatory Affairs that administer and conduct inspections of food and feed facilities and imports; 
  • The resources and facilities of the Office of the FDA Commissioner that support CFSAN, CVM and inspections;
  • USDA’s Food Safety and Inspection Service;
  • The part of USDA’s Agriculture Marketing Service that administers shell egg surveillance services;
  • The part of USDA’s Research, Education, and Economics mission area related to food and feed safety;
  • The part of USDA’s Animal and Plant Inspection Health Service related to the management of animals going into the food supply; and
  • The part of the National Marine Fisheries Service of the National Oceanic and Atmospheric Administration of the Department of Commerce that administers the seafood inspection program. 

A single food safety agency is not a new concept, and the two lawmakers have sponsored Safe Food Acts five times before, though the most recent was in 2007. In addition, the Government Accountability Office has reported on the need for better coordination of food safety activities over the years.

DeLauro mentioned eggs as an example to show how complicated the current food safety landscape was: “One agency manages the health of hens, another oversees the feed that they eat, another sets egg quality standards but does not test them for Salmonella,” she said. “While still in its shell, the egg is the responsibility of the Food and Drug Administration, but once it’s processed into an egg product, it becomes the responsibility of Food Safety and Inspection Service.”

Durbin and DeLauro are hoping to build bipartisan support for the bills. Current cosponsors of the Senate Safe Food Act include Sens. Dianne Feinstein (D-CA), Richard Blumenthal (D-CT) and Kirsten Gillibrand (D-NY). Cosponsors in the House include Reps. Barbara Lee (D-CA), Louise Slaughter (D-NY), James Langevin (D-RI), Bobby Rush (D-IL), Charles Rangel (D-NY), Jim McDermott (D-WA) and Delegate Eleanor Holmes Norton (D-DC).

Gina Kramer
Food Safety Think Tank

An Introduction

By Gina R. Nicholson-Kramer
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Gina Kramer

This new column on Food Safety Tech is a B2B forum for food safety tech, food manufacturing, food distribution, food retailer service/sales, and chemical and tools manufacturing companies in our industry. One of the important efforts we all have in common in this industry is we must continually identify food safety risk (or gaps) in food manufacturing, distribution, and sales to develop improved systems, methods, chemicals, and tools to fill these gaps and reduce risk. In the near future, many of these efforts will be mandatory due to the new regulatory rules being developed through FSMA.

Food Safety Think TankMy goal for this column is to facilitate new thinking to stimulate innovative solutions in food safety for our industry. I have the experience of leading large chain food sales and food service food safety programs; working with business professionals within our respective food companies and with our vendors, to develop systems and tools to improve food safety.

How can this column be of value to our industry?

  • Follow the column. Subscribe to FST News, and receive notifications of the column in your inbox whenever we post something new.
  • Participate. The column should be more than just a source for useful information; I actually want to start a conversation with you – industry professionals. Respond to column posts and share what you know, ask questions, submit ideas, inform us of gaps you see in food safety, and share your efforts, etc.
  • Contribute. We are actively looking for industry professionals who want to share their work in food safety. Whether it’s benchmarking existing solutions or sharing your research that defines gaps and new opportunities for innovation, we need your contributions. Let’s invoke a broad range of new ideas across a wide range of issues to speed up new or improved tools, reduce cost, improve efficiency, and even develop new business models for food safety solutions. Write to me at Gina@SavourFoodSafety.com. I look forward to hearing from you. 

FSMA: What to Expect in 2015

By Aaron G. Biros
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Companies should start preparing for FSMA immediately, caution two food safety experts. Between the proposed and final rule, there is some concern for not knowing the future, but companies should conduct FSMA assessments and build a roadmap for compliance on track with FDA timelines. So are you prepared?

Two experts from The Acheson Group – Dr. David Acheson, and Melanie Neumann, in a recent FSMA Friday webinar, discussed what companies should expect from the FDA in 2015 and how they can adjust to comply with new rules as the final deadlines approach. FoodSafetyTech presents some excerpts:

With the FSMA comment deadline closed, what can we expect from FDA in terms of finalizing FSMA?

With the agency still answering questions and conducting FSMA related activities such as dealing with deadlines and proposals, we can expect to see the agency go silent on that. We have gone through multiple comment periods already so we should expect them to stick to their timeline of implementing rules.

What is FDA ultimately seeking to achieve with these rules?

When we look at where FDA is going in 2015, we need to look at what we should be doing in the private sector under FSMA’s prevention scheme. FDA is trying to require companies to think about preventative controls. It is about understanding where your risks are and using the appropriate controls. The main issue surfaces when regulators and suppliers have different senses of what appropriate controls really are. So, thinking about risk-based strategies, whether in the supply chain, internal systems, or whether you are a grower or importer, is going to be key in planning for the future.

When is it anticipated that the FSMA rules will be finalized?

Going from reactive to proactive and preventative strategies is the essence of FSMA’s effect on shifting the regulatory scheme. Therefore we should expect preventative control rules to come out first. We must put together a monitoring program and corrective actions in our food safety plan proactively. The FDA really wants to get these rules rolled out and enforced before the administration changes in 2016 with the next presidential election so we can safely assume they will try to stick to their published timelines (most proposed rules have a deadline in Fall 2015 with the latest in the spring of 2016).

What will some of the biggest challenges be for food and beverage companies as they begin to consider FSMA compliance?

The biggest challenges will deal with how to properly manage, store, and retrieve documentation. All the traceability data, information, and production and supplier documentation that is key in a recall should be readily presentable. Having all this data and documentation, being able to produce it quickly and turn it over to the on demand is the biggest hurdle. Companies need to leverage technology to manage this risk in documentation and data organization.

What should companies be doing now to begin to prepare for FSMA as we wait for the final rules?

Companies should start preparing for FSMA immediately. Between the proposed and final rule, there is some concern for not knowing the future, but companies should conduct FSMA assessments and build a roadmap for compliance on track with FDA timelines.

Supply chain risk control and environmental monitoring are new and challenging ventures. The behavior of FDA in the past few years have shown that any company that needs to comply with preventative control rules should really pay attention to their environmental monitoring program.

HAACP systems are likely to be fairly robust and will translate quickly, but environmental monitoring could be considered the Achilles’ heel. The other Achilles’ heel is the supply chain. This was in the original statute giving FDA the authority to require supply chain risk assessments and controls. This has resurfaced in the re-proposals, which is very reflective of the foreign supplier verification program. Look at what you know about your supply chain. The expectation will be that you control those risks.

The other challenge is FDA is expecting you to look more than one step upstream. If you are buying your ingredients from a distributor, it is your responsibility to institute preventative controls in environmental monitoring Companies need an organized central repository of all upstream, internal, and downstream documentation and data.

GFSI standards compare to the preventative control rules. The standards might be highly robust but that does not necessarily mean you comply with food defense and foreign supplier verification programs. Keep all that in mind when looking strategically toward 2016.

Summarized by Aaron Biros

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

Final FSMA Rules – How to Prepare?

By Sangita Viswanathan
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Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

In a recent FSMA Fridays event, three experts from The Acheson Group – Jennifer Cleveland McEntire, Ph.D., Vice President and Chief Science Officer; <strong”>Anne Sherod, Director of Food Safety; and Valerie Scheidt, Director of Food Safety – talked about preparing for final FSMA rules. Food Safety Tech presents some excerpts:

FSMATo-DoListHow close are we to the final rules in terms of how much can things still change, and are we more confident about some rules than others in terms of how much change we might still see?

We anticipate some changes with the proposed Third Party Certification rules especially around the responsibility of auditors to have mandatory reporting to FDA if they find any signification non-conformances. And this covers findings from consultative audits as well, so we feel it may be counterintuitive to do this as companies are aiming for continuous improvement.

We also think they may be some changes with the Food Defense rule. The agency may consider how GFSI views food defense and some of the mitigation strategies that are being proposed.

But for the most part, we think the other proposed rules will pretty much be as is.

What are Top 3 things that companies should be doing NOW to prepare?

First, companies need to figure out who that qualified individual will be especially in manufacturing facilities that have to comply with the preventive controls or foreign supplier verification rule. It’s important that this qualified individual is adequate informed and understands their responsibilities and what they need to do.

Also it’s really important to understand thoroughly the preventive controls rule and how it applies to your facility for instance, to your pre-requisite programs, GMP etc. Analyze how the preventive control rule will go beyond process control, and CCPs.

Another aspect that companies are really struggling with is document management, and realizing how they will be used by FDA.

Adding a fourth to do, companies need to be thorough with Supplier Controls – understand who is in the supply chain, and how they have been approved. FDA will be interested to know if you know their risks and how you are managing them.

In the area of supplier control, FDA made some significant changes in this last round of revisions. Will these hold? If so, what should companies be doing now to prepare?

You will need to have strong supplier controls. Although it looks like a new component, it was always expected. While regulatory compliance is the baseline, what we are seeking in brand protection as an end result. There are two things to get started – get a supplier approval process in place, after assessing supplier risk and making decisions on what can control that risk. You will also need to have monitoring and verification programs, and corrective actions in place.

Step two will be managing all this information. Documentation needs to fully support this system. Companies can do this either manually, or leverage technology that they currently are using, or can look for new technology opportunities. Whatever option they choose, companies must have everything in writing, especially a list of non-negotiable items that they can provide to their suppliers to see what they can do to meet your requirements.

From a scientific standpoint, it looks like companies will need to validate safety processes. Will FDA will be flexible in accepting tried and true operations, or will new studies need to be conducted?

FDA will accept tried and true operations, e.g. if you are doing a cook process, and you are monitoring for end point internal temp of 160 degrees, or if you have pH control of less than 4.6, and if these help in eliminating pathogens, then you have scientific validation for what you are doing. However, if you are doing a new process or a novel product, and have no process that’s scientifically supported, such as cook process, temperature or pH control, you need to have supporting data. In such cases, you will need to reach out to a Qualified Individual, and possibility have to do those studies to to make sure you have scientific justification for validation of your food safety plan.

What are requirements for a qualified individual?

A qualified individual is someone who has the required education, training, and experience to make decisions that are needed. However, that FD training that is required, doesn’t exist yet. So there’s a little bit of ambiguity here. But you look at types of responsibilities and information they need to know, the individual primarily has to be knowledgeable and confident about food safety. Just because that training and curriculum aren’t out yet, it doesn’t mean that you cannot look intuitively, and tell and this is the appropriate person and identify any training they may need.

Click here to listen to this webinar, and get more of your questions answered.

Dan Okenu, Ph.D., Food Safety Manager, H-E-B
Retail Food Safety Forum

Benchmarking Produce Safety in the New FSMA Regulatory Climate

By Dan Okenu, Ph.D.
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Dan Okenu, Ph.D., Food Safety Manager, H-E-B

Produce safety featured prominently in the recently concluded Food Safety Consortium in Chicago November 17-18, 2014 for two reasons: First, produce remains the largest source of foodborne illness outbreaks in the United States, and second, the recent supplemental notice by FDA calling for another round of public comments on the proposed rule for “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.”

Thus, a consortium of growers, processors, packers, suppliers, retailers, buyers, innovators, regulatory officials and food industry consultants came together in the retail foodservice track to discuss “Benchmarking Produce Safety from Farm to Fork.”

The central question revolved around compliance with FSMA provisions to continue supporting the availability of safe quality food in a cost-effective manner. Issues surrounding the provisions of foreign supplier verification and how to engage with FSMA-exempt small local growers and suppliers on produce safety were discussed. The thorny problem of a quick and reliable traceability system for produce was also addressed. Other issues that were discussed include: how to ensure and verify good agricultural practices in the farms; introducing a safe and effective kill step in both cut and whole produce; and how to avoid cross-contamination on washed ready-to eat (RTE) fruits and vegetables. We also deliberated on how to close the gap in-between FDA audits to ensure that proper food safety practices are in place all year round.

The consortium brainstormed on how to take the current produce safety industry practices to the next level, towards a science and risk-based preventive approach as provided for in FSMA. To adequately address the issue of auditing gaps and the FSMA foreign supplier verification provision, it was suggested that it could be cost-effective for large scale buyers to embed their employee on site with large scale growers, processors and suppliers, especially for those located in foreign countries. This will support a real time status update on the food safety practices in place at such foreign facilities by your corporate employees, and in fact reduce the need for expensive frequent and auditing visits that don’t really capture everything. It can also be a conduit for training and maintenance of corporate food safety and quality standard to enhance the delivery of safe quality products, especially if your company is doing business in developing countries where food safety policies and regulatory enforcement are still in rudimentary stages.

Alternatively, make it a corporate policy to do business with only GFSI-certified facilities and increase the frequency and duration of unannounced audit visits for a more representative assessment and documentation of the prevailing food safety practices in place.

In addition, some private-label food programs involve ownership of farms, manufacturing plants and processing facilities. Thus, some retailers operate their own farms and plants both here in the United States and in foreign countries, and that may enhance active managerial control on produce safety from farm to fork. Engaging small local growers who are FSMA-exempt through an organized Agricultural Extension Services will enable resource sharing for implementing standard food safety practices and support integration in the local market. It will not only bring down cost but will also increase the availability of fresh fruits and vegetables without the need of a long distance temperature-controlled distribution network.

Both government and the private sector can support the running of these extension services in a more robust manner that builds upon the current USDA Cooperative Extension System which provides useful, practical research-based information to agricultural producers. A safety gateway could be established for produce from local growers through innovation on an effective pathogen kill step that can achieve up to 5-log reduction using effective consumer-friendly sanitizers.

GRAS classified sanitizers like electrolyte water, Ozone, hydrogen peroxide, chlorine dioxide and sodium hypochlorite are under various stages of R&D and some have been found to extend produce shelf life as well. Since the absence of a microbial risk does not preclude chemical contamination; continuous testing and monitoring for chemical residues that may result from the use of pesticides, contaminated soil or manure is recommended. A reliable produce traceability system will facilitate the investigation of foodborne illness outbreaks and timely corrective actions.Current R&D innovations in this area include the use of DNA tagging to assist in identifying both cut and whole produce even when out of the box. It was also stressed that behavior change is as important as the technology-driven interventions, and as such should be encouraged among retail and foodservice workers to embrace best practices and avoid actions that may lead to cross-contamination of RTE foods. Washing and rinsing of produce singly in running cold water is not only recommended for removing dirt and foreign matter but also for eliminating potential cross-contamination that may result from soaking fruits and vegetables.

Overall, it was a lively discussion that was spiced with practical real world examples by highly experienced industry leaders and decision makers.

Roberta Wagner, Director, Office of Compliance, for the Center for Food Safety and Applied Nutrition at FDA

How is FDA Surveillance Keeping Pace with FSMA Changes?

By Sangita Viswanathan
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Roberta Wagner, Director, Office of Compliance, for the Center for Food Safety and Applied Nutrition at FDA

Proposed rules under the Food Safety Modernization Act will mandate more inspections, more testing, and better risk-based profiling of food products – both sourced domestically and imported. How is FDA planning to keep pace with these changes? Roberta Wagner, Director, Office of Compliance, for the Center for Food Safety and Applied Nutrition at FDA, provided some insights, while speaking at the recent Food Safety Consortium, organized by Food Safety Tech. 

Section 201 under the Food Safety Modernization Act requires the Food and Drug Administration to designate food facilities at high-risk and non high-risk facilities, and accordingly, establish minimum frequency of inspection of these facilities. While high-risk facilities will have to be inspected by FDA once every three years, facilities deemed non high-risk will be inspected once every five years. Wagner described that the following factors have been considered so far for determining if a domestic food manufacturing facility is determined to be high-risk or otherwise:

  • Whether the facility has been involved in a Class 1 outbreak or recall;
  • Whether the facility has a history of non-compliance (based on Official – Action Indicated (OAI) or Voluntary Action Indicated (VAI) data);
  • If the facility has had any significant violations;
  • Future data considerations (see below);
  • Type of activity the facility is involved in; and
  • Date of last inspection.

Future data for consideration of high-risk and non high-risk categorization will include:

  • Inherent risk factors at product level (for instance is the product bakery goods, or seafood/ fresh produce etc);
  • Has the facility been linked to an outbreak, recall or adverse event (if so the risk profile gets elevated);
  • If any sample testing (product or environmental) is positive;
  • If there’s a history of customer complaints;
  • Robustness of QA/QC programs and 3rd part audit reports;
  • Financial viability of the company; and
  • Food safety culture of the facility/ company.

Foreign facility inspections

Under FSMA, FDA has also been mandated to increase the number of inspections the agency does on foreign facilities, to ensure the safety of imported foods. Wagner explained that FDA currently conducts about 1200 foreign facility inspections a year to determine if those facilities meed FDA regulations. With FSMA rules, FDA will have increased authority to conduct such inspections of foreign faciligies, and look at Foreign Supplier Verification Programs, and Voluntary Qualified Importer Program records, adds Wagner.

Under the new regimen, FDA has been mandated to conduct at least 600 foreign inspections during the first year of FSMA rule implementation. And the target is to double this number every year, for the next five years, taking it to 19,200 inspections by Year 6. Wagner feels this is an impractical number as FDA does not have the resources to do so many foreign inspections. “If we get the Foreign Supplier Verification Program under FSMA rule right, we effectively place the responsibility for ensuring safety of imported foods on the food industry and importers. FDA cannot, and should not be doing this,” she explains.

Risk-based foreign facility site selection

FDA will also adopt a risk-based approach to select foreign facilities for further inspection. This approach will consider:

  • Food safety risk associated with the sector or commodity;
  • Risk associated with manufacturing process;
  • Compliance history of facilities associated with an industry sector commodity in a given country or region (for instance, look at refusal rates for products denied try into the U.S. by country);
  • Quantity or volume of imported product from country or region;
  • Robustness of food safety system in the country; and
  • Portion of resources retained by the facility for compliance, follow up inspections and emergency response situations.

Based on this FDA will continue to diversify the product that it considers high risk, for instance dairy, baby food, candy… Wagner added that economically motivated adulterated continues to be a concern and cause for focus on food products such as oils, honey and dietary supplements.

Wagner also talked about Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting or PREDICT, a risk management tool used by FDA to efficiently and effectively make entry admissibility, decisions that prevent entry of adulterated, mis-branded or otherwise violative imported goods into the U.S., while expediting the entry of non-violative goods. Based on risk scores allocated to different products, this computerized tool targets entries of highest risk for further scrutiny, including field reviews and sampling.

She explained that this dynamic tool, which constantly adapts to different risk situations and products, provides automatic data mining and pattern recognition, provides automated queries of FDA databases including facility registration information, and thus, allows for risk-based allocation of FDA resources.

Purnendu C. Vasavada, Ph.D., Professor Emeritus at University of Wisconsin

What Should You Know About Food Safety Testing?

By Sangita Viswanathan
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Purnendu C. Vasavada, Ph.D., Professor Emeritus at University of Wisconsin

Food safety is in the news. Recent food industry, regulatory and consumer trends stress proactive, systematic and preventive approach to food safety by managing food hazards and risks. Testing for food safety hazards, particularly microbial hazards and allergens throughout the food production and processing chain is becoming increasingly important in assuring food safety. Food testing is also becoming important for detection of adulteration.

In next week’s Food Safety Consortium to be held in Schaumburg, IL, Purnendu C. Vasavada, Ph.D., Professor Emeritus at University of Wisconsin, River Falls, and President of PCV & Associates, LLC, will discuss trends in the food safety testing market and approaches for testing of food and food plant environment, emphasizing microbial and other significant food hazards. In this article, PC, as he is popularly referred to, gives a sneak-peek into his presentation.

Food Safety Tech (FST): You will be speaking about the Food Testing Market – what are some broad trends that you are seeing?

PC: Food Microbiology testing is increasing worldwide but majority of testing is still dealing with food quality assurance and ingredient and product testing. Testing for pathogens seem to be driven by regulatory requirement. According to recent market reports, 76 percent of test volume in North America is for routine microbiology. In the EU and Asia, routine microbiology accounts for 81 percent and 72 percent of test volume, respectively.

Most pathogen testing is for Salmonella, E. Coli 057:H7 and Stex, Listeria and as L. monocytogenes. There is an increasing interest in testing for Campylobacter.

Testing of in-process and environmental samples is more common in NA and Europe. In Asia in-process/environmental testing only accounts for 9 percent of total test volume.

FST: In your presentation at the Consortium, what will you talk about FSMA and its impact on food safety testing?

PC: I plan to include a brief discussion on testing as related to monitoring and verification of Preventive Controls.

FST: Where is food safety testing headed, and what should food safety managers keep in mind?

PC: Given the emphasis on supply chain management and process control to manage identified hazards in preventive mode, food safety managers should understand testing internal and external testing requirements and complexity of sampling, testing tools and approaches not simply focus on cost aspects. Even if testing is outsourced, becoming familiar with various methods and testing tools will be necessary.

FST: Who should attend your presentation and why?

PC: Plant managers, quality assurance supervisors, marketing managers, food safety testing methods, equipment and service providers as well as anyone interested in food safety testing would find this presentation very useful and relevant to their day-to-day activities.

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Shannon Cooksey, MS, PMP, Senior Director, Science Program Management at the Grocery Manufacturers Association

Food Safety Consortium Sneak Peek – Food Defense Rule

By Sangita Viswanathan
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Shannon Cooksey, MS, PMP, Senior Director, Science Program Management at the Grocery Manufacturers Association

The Food Safety Modernization Act is the first instance of codified food defense regulations. This discussion is a hard look at the proposed food defense requirements and examining what compliance may look like. 

At the upcoming Food Safety Consortium, to be held November 17-18 in Schaumburg, IL, Shannon Cooksey, MS, PMP, Senior Director, Science Program Management at the Grocery Manufacturers Association (GMA), will address the key takeaways associated with the proposed regulation.

Following this presentation, Sarah Sunday from Kraft will talk about challenges the industry will face in implementing the rule as written and how the industry currently addresses food safety.

In a chat with Food Safety Tech, Cooksey provides a sneak-peek into her presentation.

FST: How are Food Defense requirements evolving under proposed FSMA rules?

Cooksey: GMA led industry in developing comments on the proposed Food Defense rule earlier this year, specifically focusing two things: one, food defense is different from preventive controls and two, food defense cannot be prescriptive—it needs to be tied to a facility-specific risk evaluation. While FDA has not yet re-proposed new food defense language as part of the supplementals released on September 29 of this year, we have good reason to believe that FDA has shifted some of its positions in light of our comments. We also believe another opportunity to submit comments on a food defense supplemental proposal, similar to what was done with Preventive Controls, would be a valuable use of time for both the industry and the Agency as they move towards issuance of a final food defense rule in May of 2016.

FST: What are some things that companies need to keep in mind to be prepared to comply with these requirements?

Cooksey: While this is the first time food defense is being proposed as a regulation, there are already some existing training materials available to industry to begin developing food defense plans. Since the requirement to have someone specially trained in food defense will likely be part of the final rule, GMA recommends that companies start early and take advantage of the available materials already available. GMA and the GMA Science and Education Foundation are planning to release additional materials and courses in 2015.

FST: Who should attend this discussion, and how would they benefit from it?

Cooksey: Security specialists at the facility and corporate level regulatory affairs staff who oversee food defense and/or FSMA within their companies should attend. Also, food quality assurance and food safety managers will need to know how the food defense plan will work in combination with food safety plans.

Click here for more information on the Food Safety Consortium, and learn from over 75 of the Food Industry’s top food safety SMEs.