Tag Archives: FSMA

8 Food Industry Trends Fueled by FSMA

By Lori Carlson
No Comments

FSMA is fostering a surge in technology solutions, analytical tools and training products marketed to the food industry in the name of achieving FSMA compliance. And while many of these products were available pre-FSMA (especially in other industries like the life sciences), FSMA’s momentum has fueled the adaptation of solutions to meet the specific needs of the food industry for achieving and maintaining regulatory compliance. This article is a summary of emerging trends in food safety management by producers, manufacturers, distributors and retailers through the application of technology, educational tools, monitoring and detection systems, and other support mechanisms.

Want to learn more about FSMA trends and compliance? Attend the 2016 Food Safety Consortium in Schaumburg, IL | December 7–8 | LEARN MOREWhether by the spark of FSMA or because it makes practical sense (and most likely, a bit of both), businesses are integrating their food safety programs with enterprise initiatives and systems for managing compliance and risk to achieve increased visibility and harmonization across the organization.  The most popular trends fueled by FSMA largely reflect technology solutions to achieve this integration.

Subsequently, solutions that support risk assessment, supply chain management, real-time monitoring, corrective action, self-assessment, traceability, and training management are most attractive and lucrative from an ROI perspective. And while it may be hard to find a one-size-fits-all technology solution depending upon the needs of the organization, technology service providers are quickly raising the bar to meet these growing needs as organizations strive to reduce risk and increase compliance. Other top trends at the periphery of technology solutions include the mobilization of food safety personnel and increased availability of on-demand training and detection tools to bring the FSMA movement full circle.

1. Software-as-a-service (SaaS) technology solutions quickly gained a following in the food industry in recent years to achieve an automated food safety and quality management system (FSQMS) solution.

The substantial management components and recordkeeping requirements of the FSMA rules has accelerated the food industry’s need for automated solutions to document program management, queue workflows and distribute notifications for corrective and preventive action (CAPA). Understanding this need, many SaaS providers evolved with FSMA to provide functionality that dovetails with new regulatory requirements.

2. Increased availability of risk and vulnerability assessment tools is of significant importance in meeting many requirements of FSMA’s rules.

The regulatory language of all FSMA rules is steeped in risk analysis to support the prevention of food safety hazards and threats. This creates a demand for user-friendly tools and training courses to help food businesses analyze and update their management systems within the context of these new requirements. Risk and vulnerability assessment tools currently available to the food industry are diverse in functionality and vary in scope and cost.

For example, FDA’s free online tool, FDA-iRISK 2.0, assesses chemical and microbiological hazards in foods through process models, which quantify risk across scenarios and predict the effectiveness of control strategies.  Commercially available food hazard assessment tools based on HACCP/ HARPC principles include Safefood 360° and EtQ, which provide risk assessment modules as a part of their SaaS platform.

Universities, trade associations, and commercial risk management and consulting firms came together to produce two very different food fraud vulnerability tools to support the industry. SSAFE by the University of Wageningen RIKILT, Vrije Universiteit Amsterdam and PricewaterhouseCoopers (PwC) is a free online tool and mobile app, which guides users through a decision tree and assessment questionnaire to determine fraud opportunities, motivators and gaps in existing controls. EMAlert by the Grocery Manufacturers Association (GMA) and Battelle is a subscription-based online tool to assess vulnerability from economically motivated adulterants (EMA’s). Individuals conducting vulnerability assessments are recommended to periodically access food risk databases such as the U.S. Pharmacopeial Convention’s (USP) food fraud database to stay informed of historical and emerging threats to the supply chain.

And in support of FSMA’s Food Defense rule, the FDA developed a free food defense software tool, Food Defense Plan Builder (FDPB), to help food businesses identify vulnerability to intentional adulterants and terrorist attacks on the food supply chain.

3. SaaS platforms, app-friendly assessment tools and FSMA recordkeeping requirements are creating a natural pathway for the increased use of mobile devices and electronic recordkeeping and verification.

From supply chain management to effective traceability to regulatory compliance, efficient document management and on-demand data retrieval is a must have of the modern FSQMS. Food businesses recognize the inherent obstacles of paper-based systems and increasingly trend towards rugged mobile devices and electronic recordkeeping to make better use of personnel resources, technology solutions and data. FSMA is helping leverage this trend two-fold through increased requirements for documentation and verification of food safety management activities and by not requiring electronic records to additionally meet the provisions of 21 CFR part 11 (electronic recordkeeping).

4. An increased demand for more effective, frequent and accessible training must be met across an organization to maintain an adequately trained workforce responsible for implementing FSMA.

To keep up with this demand—as well as the training demand imparted by GFSI schemes and fact that a company’s FSQMS is only as good as those who develop and operate it—food businesses are turning to online and blended learning courses to increase training frequency and effectiveness. In Campden BRI’s 2016 Global Food Safety Training Survey, 70% of food processors and manufacturers responded that they received training deficiencies during audits as the result of a lack of refresher training and/or lack of employee understanding.

In an effort to help close this gap and meet new implementation requirements of FSMA, food safety training providers are increasing offerings of eLearning courses, which provide targeted content in shorter duration to meet users’ needs in an interactive (and often multilingual) format. Shorter and more frequent targeted training is proven to increase knowledge retention and job performance. E-Learning training solutions can be found through dedicated training service providers as well as universities, trade associations, regulatory agencies, scheme owners, certification bodies, and other compliance organizations.

Depending upon the training provider, online training may be distributed through a learning management system (LMS) to provide additional training tools, assess training effectiveness and manage the training activities and competencies of all participants.

5. Targeted monitoring and verification activities such as product testing, environmental monitoring or water quality testing are helping to increase the demand for pathogen testing and push the frontier of improved rapid pathogen detection methods.

In a recent Food Safety Tech article, Strategic Consulting, Inc. noted more than a 13% annual increase in pathogen testing by contract food laboratories as determined by a recent industry study conducted by the group. The study additionally identified turn-around-time as the second most important factor for suppliers when choosing a contract lab. Increased access to rapid pathogen testing—and in particular, detection without time-dependent cultural enrichment—are primary needs of food businesses as regulators and customers push for enhanced monitoring and verification via testing mechanisms.

Currently, there are numerous rapid methods based on DNA, immunological or biosensor techniques. These methods can detect foodborne pathogens in relatively short amounts of time ranging from a few minutes to a few hours. But they often require pre-processing strategies to reduce matrix interference or concentrate pathogens to meet the level of detection (LOD) of the assay.1 These strategies increase the overall time of the assay and are largely the next hurdle for improved rapid detection.

6.  Food businesses are experiencing a wave of self-assessment followed by CAPA as organizations work to analyze and update their food safety systems and protocols within the context of applicable FSMA rules.

This trend has the potential to be the most beneficial to the supply chain and consumers as it provides a distinct opportunity for food businesses to reconsider previously overlooked hazards and vulnerabilities and upgrade food safety controls along with the management system. Seeing the FSQMS with fresh eyes—outside of the framework of a familiar standard—can lead to significant improvements in food safety management, product safety and quality, and even operational efficiency.

7.  For many food businesses, heightened regulation has spurned the need for dedicated staff to support compliance efforts.

Many food businesses are subject to multiple rules—some of which require a dedicated individual such as the Preventive Controls Qualified Individual (PCQI) to assume responsibility for the implementation of various provisions. And food businesses are not exempt from the acute need for qualified individuals with a food safety skill set. Across the industry, from service providers to retailers and everyone in between or at the fringe, executives understand that it takes tireless leadership and knowledgeable staff to produce safe food.

8. More than any other trend, communication on FSMA, food safety and related topics is easily the most prevalent exhibiting exponential activity over the past five years.

Whether in support or contention with the proposed (now final) rules, FSMA promulgates constant dialogue about food safety, what it means and how it should be implemented. The constant flurry of communication provides both benefits and deterrents to understanding the new regulations and identifying effective solutions for compliance. This dichotomy creates a significant need for authoritative and easy-to-understand information from consolidated sources within the industry such as trade associations, risk management organizations and food safety schemes. The divide has also helped fuel the need for information hubs like the Global Food Safety Resource (GFSR) that aggregate critical regulatory information, food safety solutions and best practices to reach a global community.

Reference

  1. Wang, Y. and Salazar, J.K. Culture-Independent Rapid Detection Methods for Bacterial Pathogens and Toxins in Food Matrices. Comprehensive Reviews in Food Science and Food Safety. 2016; 15(1): 183-205.
Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC
FST Soapbox

Qualified Food Plant Safety Individuals

By Bill Bremer
3 Comments
Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC

The new requirements under Section 117 cGMPs of FSMA mandate that a “Qualified Individual” oversee the hazard analysis, preventive control process and Food Safety Plan. The expectation is that a plant operator designates qualified resources who are adequately represented during all food processing and handling at registered sites. In addition, the Qualified Individual stipulation requires that the organization provide resources to maintain the company’s GMP program and food safe processing, and to oversee key regulatory activities.

Learn more about FSMA compliance at this year’s Food Safety Consortium in Schaumburg, IL | December 7-8, 2016

Qualified or Competent Individual under FSMA Hazard Analysis and Risk-Based Preventive Controls

The organization must provide Qualified Individuals in all areas to ensure the food safety of product processing, production and distribution. The key roles under “Qualified Individual” are described under Subpart C Section 117.126. This statute requires that the food safety system and plan requirements must be overseen by Qualified Individuals. This includes development of a Food Safety Plan—prepared, or its preparation overseen, by one or more preventive controls Qualified Individuals. Additionally, the statute, as described in cGMPs, indicates that experience, education, certification and other qualifications are appropriate for companies to determine Qualified Individuals.

Other FSMA requirements under Section 117 include the following (as summarized and aligned for specific cases):

  • 117.160(b) (1) Validate that preventive controls required under 117.135 are adequate to control hazards in the facility’s Food Safety System prior to development of the Food Safety Plan by Qualified Individual, or:
    • 117.160 (b) (2) validation of preventive controls within 90 days or a reasonable timeframe after production of applicable food begins by Qualified Individual.
    • 117.160 (c) food not applicable based on factors such as the nature of the hazard (including allergen, sanitation controls, recall plan, supply chain program or determined non-applicable hazards), as determined by Qualified Individual.
  • 117.165 (a) (4) As appropriate to the facility and its role in the Food Safety System, review records that are effective and make decisions about corrective actions by a Qualified Individual.
    • 117. 165 (a) (4) (i) Maintain records of monitoring and corrective actions within seven working days after the records are created by Qualified Individual.
  • 117.170 (c) (2) (ii) Reanalysis by the Qualified Individual every three years for the written justification of the Food Safety Plan exceeding 90 days after production of applicable food.
    • 117.170 (c) (2) (e) Preventive controls Qualified Individual must perform (or oversee) the reanalysis.
  • 117.180 Requirements applicable to a preventive controls Qualified Individual and Qualified Auditor are described in this section with the introduction of the Qualified Auditor-level resource.
  • 117.180 (a) One or more preventive controls Qualified Individuals must do or oversee:
    • Preparation of the Food Safety Plan
    • Validation of preventive controls
    • Written justification for validation that exceeds the first 90 days of production.
  • 117.180 (a) General processes and controls.
    • Overall sanitation of the plant must be under the supervision of one or more Competent Individuals assigned responsibility for this function.
  • 117.190 Implementation records required for this subpart.
    • Records that document applicable training for preventive controls Qualified Individual and Auditor.

These requirements under FSMA list the necessity of multiple Qualified Individuals, Qualified Auditors, and Competent Individuals for sanitation. Accordingly, all management and personnel must know, understand and be trained for the food safety aspects of their jobs.

Self-Diagnostic Assessment Tool

The following self-diagnostic assessment tool can help organizations better determine their current state of planning when it comes to determining and deploying the various Qualified Individuals in meeting FSMA. To complete your own planning assessment, review your progress compared to the questions below.

Food Safety Plan, Qualified Individuals, Checklist
Table I. Kestrel Management’s self-diagnostic tool can help a company assess its level of Food Safety System and Plan preparedness for FSMA compliance for the Qualified Individuals and personnel necessary to meet FSMA requirements.

Get Compliance-Ready

Companies must have the appropriate resources to comply with FSMA or face possible violations, fines and penalties under FDA enforcement. The questions in Table I will help companies identify the areas in which they need to focus attention. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage GFSI certification—and change “No” responses into “Yes” responses that promote best practices for FSMA compliance.

FSMA Preventive Controls: Are You Prepared?

Get the checklist to assess your company’s readiness level. It’s a crucial part of the compliance process.
FSMA

FDA Awards Nearly $22 Million to States for Produce Safety Rule

By Food Safety Tech Staff
No Comments
FSMA

FDA has awarded $21.8 million to 42 states to support the implementation of the FSMA Produce Safety rule. The State Produce Implementation Cooperative Agreement Program (CAP) provides states with the resources to enable the following:

  • Form a multi-year plan to implement a produce safety system
  • Education, outreach and technical assistance
  • Prioritize farming operations covered by the rule
  • Develop programs to address the needs of farming communities

According to FDA, “the intended outcomes of this cooperative agreement program are to:

Advance efforts for a nationally integrated food safety system (IFSS)
Plan, establish, and/or enhance state and territorial produce safety programs.
Encourage the safe production of fresh fruits and vegetables.
Promote understanding and compliance with the requirements of the Produce Safety Rule.”

Applicants were classified into five tiers of funding eligibility based on the number of farms growing covered produce within the jurisdiction. The agency has also provided a list of funding award amounts by state.

Learn more about FSMA at the 2016 Food Safety Consortium | December 7–8, 2016 | Schaumburg, IL | VIEW AGENDA

 

Randy Fields, Repositrak
FST Soapbox

Food Safety Collaboration across the Value Chain

By Randy Fields
No Comments
Randy Fields, Repositrak

FSMA is the law of the land and the FDA is starting to enforce compliance, so now is the right time to discuss what’s working and what isn’t in terms of trading partner collaboration. Just how are companies successfully coordinating the movement of goods from the point of production and processing to the American consumer and ensuring food safety throughout the value chain?

Risk reduction continues to be the focus of collaboration between trading partners, with the understanding that failing to meet compliance requirements can mean big fines for companies and jail time for executives. We’ve seen a marked increase on this topic in the sessions at trade shows and conferences, and the number of webinars and other educational opportunities has soared during the past year. Most importantly, the number of meetings continues to increase between retailers, suppliers and carriers where the discussion of food safety compliance and risk reduction is high on the agenda.

Eliminating risk is always top of mind for a company’s lawyers and accountants, but recent issues have caused other company functions to increase their collaboration with contacts at trading partner companies. On the retail side, merchandisers are holding vendors accountable for compliance and requiring food safety documents for new suppliers at signup. Purchasing is reconfiguring the purchasing process to suspend or stop PO generation and payment if a supplier is out of compliance. And, store operators are alerted to potential safety concerns, so they can act expediently on behalf of their consumers.

For suppliers, sales teams are getting necessary training on food safety, and they are using this knowledge to engage customers and protect their brand equity with consumers. Their supply chain and IT managers are also managing to the new FSMA normal of managing dozens of new documents and present written records in accordance with the 24-hour requirement. For their part, transportation companies are working to meet new FSMA requirements that demand assurance in writing that food was transported under proper sanitary conditions.

What’s Driving This Collaboration?

Similar to Sarbanes-Oxley, CEOs are responsible for verifying the compliance of their supply chain under FSMA. Given these risks, companies have started to automate their management of compliance documentation. Forward-thinking companies are even moving beyond compliance document management and are applying the same technology to ensure that important product information like gluten-free items and allergen-related declarations are properly documented.

Collaboration is supported in today’s environment by technology, which saves companies both time and money by leveraging automation to ensure the accuracy of documents (e.g., indemnifications and insurance), providing executives with information on which to make better business partner decisions.

Collaboration is a critical cog in the wheel of the value chain that helps provide the consumer with a safer food supply while reducing both brand risk to suppliers and retailers and health risk to all. The industry needs to strengthen its working relationships to ensure this effort continues without constraints.

Imports

Industry Needs More Help Understanding Import Safety Under FSMA

By Food Safety Tech Staff
1 Comment
Imports

Need help understanding FSMA? Attend the 2016 Food Safety Consortium, December 7–8 in Schaumburg, IL | LEARN MORE In a 22-page report released last week, FDA outlined its findings from three public meetings held in June about the implementation of the FSMA import safety programs. The report, “Focus on Strategic Implementation of Prevention-Oriented Import Safety Programs”, reviews the questions asked to participants about challenges and understanding in complying with the Foreign Supplier Verification Programs (FSVP), Accredited Third-Party Certification, and the Voluntary Qualified Importer Programs (VQIP) under FSMA. The agency analyzed data from 350 participants, and made the following conclusions:

Industry wants help in understanding what is required under the FSMA provisions, including clearer, concise information from the FDA

  • Industry may achieve faster compliance with FSVP if members are shown how it differs from existing food safety practices and compliance schemes
  • Organizing FSVP compliance information by commodity and sector may help in faster comprehension of rule
  • Small importers and food producers are at higher risk of failing to comply with FSVP
  • Generating case studies and other foreign supplier education mediums may aid in faster compliance with FSVP requirements
  • Importers will likely consider cost, return on investment and effort necessary to participant when deciding whether to sign up for VQIP, which will provide expedited clearance to qualified participants
  • Industry would benefit from FDA sharing information in a faster, clearer and more concise manner
  • FDA can use its existing facility registration database and existing relationships with industry to continue outreach efforts and elevate FSMA and FSVP compliance awareness
FDA

FDA Extends Compliance Dates for FSMA Rules, Releases Draft Guidance on PC Rule

By Food Safety Tech Staff
No Comments
FDA

FDA recently took action to aid industry with the upcoming FSMA compliance dates. The agency issued two draft guidances with the intent of helping both domestic and foreign companies comply with the CGMP requirements and the human food by-product requirements in the FSMA Preventive Controls for Animal Food rule.

FDA is also extending compliance dates for provisions within the FSMA Preventive Controls, Foreign Supplier Verification Programs and Produce Safety rules. According to an agency release:

“The changes include providing more time for manufacturers to meet requirements related to certain assurances that their customers must provide, more time for importers of food contact substances, and other extensions to align compliance dates for various other food operations or provide time for FDA to resolve specified issues. The rule also clarifies the timeframe for agricultural water testing.”

In addition, FDA also released the draft guidance, Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities.

All three drafts are available for public comment. More information is available on FDA’s website.

Elise Forward, Forward Food Solutions
FST Soapbox

Embracing the New Direction

By Elise Forward
No Comments
Elise Forward, Forward Food Solutions

Food safety and quality assurance professionals are called upon to be change agents and leaders. It is important to embrace change, growth and continuous improvement, as these are the keys to success. With the arrival of FSMA, the culture of the food industry as a whole is going to get a boost, and we need to embrace the change that is coming. We are called to be cheerleaders for change and to encourage others to assist as changes are made. The food safety culture of an organization is reflected in how a company responds to necessary changes.  However, it is often more than the systems that can use improvement; the culture could use some reinforcement as well.

Elise Forward will be speaking at the 2016 Food Safety Consortium, December 6–7 in Schaumburg, IL | LEARN MOREIn part two of a series on food safety culture, we continue to look at how food safety professionals can positively influence the food safety and quality culture of our respective organizations. In Part I, the people of the organization were recognized as critical to the food safety culture. In Part II, we will discuss the remaining items that affect food safety: access to resources, systems and opportunities for growth.

Access to Resources

Doing a job properly, efficiently and well is very difficult without the proper resources. One of the greatest challenges is to convince upper management that there is a need for additional labor, equipment and/or resources. Food safety culture is not about being the best; it is about going above and beyond and thinking outside of the box. Do not let the customers, FDA or CDC’s Pulsenet “catch” an issue. It is imperative to be proactive, look for problems and be innovative. This is part of the food safety/QA job, and support is needed from upper management. People, equipment and infrastructure must be connected to food safety issues and have a dollar amount put on them. The focus should not be on how much these activities or resources cost, but rather the savings that will occur because these food safety measures are preventing problems.

Considerations: Could a lack of resources lead to less cleaning? Could this cause a build-up of biofilms of unwanted and problematic bacteria, leading to a recall? Often production resources can be quantified as lost product produced. If production and quality have a new person, make sure that drains get extra scrubbing during downtime or that the walls and corners where the extra hoses are stored get added attention. What about any peeling paint? Or, dust on the overhead pipes? Who is attending to these items? Do you need a quality management system to manage the flow of information? Could a lack of this be severely detrimental in the event of a supplier withdrawal or recall? What is the value of time spent versus the benefits that a company-wide system could bring?

Systems

All food safety systems are under the microscope and getting an overhaul thanks to FSMA. As with any time that change is in the air, having a plan of action is helpful. The Plan-Do-Check-Act (PDCA) cycle is an easy-to-remember resource that can be useful when managing changing systems. Using this method provides the backbone to assist in the documentation of the change as well as evaluating the change and ensuring effectiveness.

  1. Plan. Create and document a plan for the changes. Include who, what, where, when, why and how in the plan.
  2. Do. Execute the plan and remember to document the actions.
  3. Check. Make observations, conduct interviews and audit the changes that were made. Document your findings.
  4. Act. Make any modifications to the system based on audits, interviews and observations. Document the actions taken and any required follow-up.
  5. Repeat the cycle until the results are satisfactory. Keep in mind that the goal is continuous improvement and should not be considered a one-time task.

In all things food safety and quality related, documentation of your efforts is critically important. The old adage, “if it is not documented, it was not done” rings true. The systems will be enhanced and people in the organization will see the importance of the changes and their role in the improvement of the systems if these items are documented.

Embracing Opportunities for Growth

Many people balk at change, probably because they cannot see the opportunities on the other side. Food safety and quality professionals also need to be able to communicate to all levels of the organization when change needs to happen. We need to talk about the changes, and whether they are required or desired. It is important to talk about the benefits, which help employees see beyond the uncomfortable time during the change. Do this through meetings with executives, doughnut days with shift employees, and pizza lunches with middle management. Implement incentive programs to reward people who are making good decisions and showing food safety leadership.

Since everyone will be impacted, it means that as quality professionals we need to band together. We are each other’s best customers. Let’s rise to the top, work together and expect the best of each other. If your customers are asking for stronger food safety systems than what is currently in place, use this to support your efforts in bettering the organization’s programs. If your organization cannot meet your customer’s food safety and quality requirements, will you have adequate sales? Probably not.

Being a cheerleader for change and improvement can be tough! Create a support group for yourself. Being the problem solver, leader and change agent can be draining at times, especially with a very small team. Ensure the renewal of the food safety team and yourself by connecting with other professionals through trainings, conferences, trade associations, etc. At a minimum, read leadership blogs in addition to the food safety and quality blogs and groups that are available. All of these avenues can provide support, encouragement and connection to others in the industry as well as serve as a resource for best practices.

Conclusion

How do you implement the changes that need to occur with FSMA? Slowly and surely. Plan the strategy for implementation. Be persistent. Communicate with all levels of the organization by being a teacher, coach and leader; avoid being a cop. FSMA requires changes to the food safety programs of every food company that supplies products to the U.S. food market. We must not sit by the wayside but rather constantly teach, mold and shape the leaders who are in current management as well as the future managers who are just starting their careers. Before we know it, we have again been change agents, not in the bold and loud way, but in the soft and subtle way that can create a lasting effect and will forever positively influence the food safety and quality decisions in our organization.

Food Lab count

Infographic: How Many Food Labs Are in the United States?

By Food Safety Tech Staff
No Comments
Food Lab count

Food Safety Tech: Earlier this year in “Counting Food Laboratories”, you discussed the fact that there is an unknown amount of food laboratories in the United States and an inconsistency in how we account for the labs testing our food. What impact does this have on the industry?

Robin Stombler, president of Auburn Health Strategies: There is limited information available on the presence and quality of food laboratories in the United States. Without this essential accountability, the health of the public, the economy and our nation’s security are at risk. For example, when a new food pathogen emerges, we do not have a system for contacting and educating all existing food laboratories on how to detect it. Frankly, we do not know where all food laboratories are located, so we do not know if they are properly equipped to handle the detection, monitoring or verification responsibilities. The lack of data also makes it difficult for industry to plan, track testing trends, and improve quality.

Counting Food Labs
Infographic courtesy of Auburn Health Strategies; Credit: Justin Stombler
Alert

How Safe Is Your Facility from Threats?

By Maria Fontanazza
No Comments
Alert

Vulnerability assessments are a key provision of the FSMA final rule, Mitigation Strategies to Protect Food Against Intentional Adulteration. With this requirement comes the “identification of vulnerabilities and actionable process steps” that must be taken to mitigate potential threats. During the IAFP annual meeting Lance Reeve, senior risk management consultant for food safety and defense at Nationwide Agribusiness Insurance Co., reviewed the important and sometimes-overlooked areas that companies should be looking at when conducting vulnerability assessments.

Inside the Plant

To start, vulnerability assessments should be conducted at different times of the day, and the process should involve a team approach, said Reeve. Food defense cannot effectively be managed by a single person within a facility: It needs to involve all departments, from human resources to IT to production to warehousing, and extend to outside suppliers and vendors. How is the flow of employees and visitors around the facility managed? Do staff members wear color-coded badges? Some companies have a color-coding plan to prevent contamination, but it is also a useful tool to ensure that unauthorized employees, outside contractors and visitors aren’t in restricted areas. For example, the maintenance shop may contain deadly food contaminants—do you really want general employees to be able to get into this area? Consider using electronic technology such as biometric access control to limit access based on employee/security credentials.

Working with the human resources department is a critical part of protecting a facility. Does your company have the capability to conduct thorough background checks on all employees? In addition, with all the different types of contractors and vendors who enter your facility it’s important to find out whether your contracting companies are doing the same level of background checks as your organization when they hire employees.  And finally, examine how the culture within the organization. Do employees challenge the presence of visitors who shouldn’t be on the premises?

Outside the Facility

In many cases, companies will look at the inside of their facility for potential hazards and vulnerabilities, but what about the perimeter? How are you controlling the people who are coming onto company property? While this may seem obvious, Reeve recommended physical objects to establish authority: Fences (establish physical border), signs (establish where control begins), and CCTV cameras (establishes security). And when looking at the outside of the building itself, how secure is the roof? What access does a potential attacker have into the facility via the roof? How often are security checks conducted here (if at all)?

Throughout any given day, a company can receive several cargo shipments from a variety of different suppliers. Are you familiar with the food safety programs of your suppliers? They play a critical role in food defense strategies. And when your company receives shipments, Reeve advised that companies go beyond looking at the seals on trucks and examine the transportation system itself. Is cargo removed in a secure area? Is an authorized employee supervising the process or is it left in the hands of the third-party driver?

And finally, a critical part of your mitigation strategy should be to challenge the system. Once you think you may have found all the vulnerabilities, conduct penetration testing.

Stephen Ostroff, FDA

Pathogens, Partnerships and FSMA: Where FDA Is Headed

By Maria Fontanazza
No Comments
Stephen Ostroff, FDA

This year is a big year for food safety at FDA. All seven of the FSMA rules have been finalized, and the first compliance date is right around the corner (compliance with the Preventive Controls for Human Food rule starts in September for large companies). Stephen Ostroff, M.D., just took the helm from Michael Taylor as the agency’s deputy commissioner for foods and veterinary medicine. And finally, FDA is taking a hard line in both improving the tools and methods used to detect outbreaks as well as working with the Department of Justice to prioritize enforcement actions against companies that introduce adulterated foods into the supply chain.

Yesterday Ostroff provided an update on FDA’s recent initiatives and its plan of action to achieve success in FSMA implementation and pathogen detection at the IAFP annual meeting in St. Louis. Ostroff highlighted several tenets of FSMA:

  • Keys to FSMA success will be dependent upon achieving high rates of compliance
  • Domestic and import parity
  • Education before and while regulating (establishment of training and education networks)
  • Taking a risk-based approach to inspection and planning
  • Partnerships are critical
Stephen Ostroff, FDA
FDA’s Stephen Ostroff will be the opening keynote at the 2016 Food Safety Consortium, December 7 in Schaumburg, IL. LEARN MORE

Industry can expect three more rulemakings as required by FSMA in the areas of lab accreditation, a reportable food registry and product tracing. In addition, FDA is working on guidances related to the preventive controls, produce, and foreign supplier verification program rules. “We’re tantalizingly close so stay tuned,” Ostroff said.

Expect to see more program alignment with the Office of Regulatory Affairs as well. The inspection and compliance staff will be trained as specialists and there will be horizontal integration of programs between field activity and agency headquarters. Although the next fiscal year will be a transition year, Ostroff is hopeful that changes that need to be made at the agency, along with program alignment, will be in place by fiscal year 2018.

Other notable actions at FDA over the past year include:

  • In response to the OIG’s conclusion that FDA’s food recall program is not efficient or effective, the agency is ramping up its use of the strategic CORE (Coordinated Outbreak Response and Evaluation) network in order to examine recalls that might not be moving as smoothly or quickly as the agency prefers. FDA is also leveraging greater application of whole genome sequencing (WGS).
  • GenomeTrakr network and WGS. More than 50,000 genome sequences have been added to the database (largely Salmonella). Ostroff called WGS a game changer that holds the opportunity to more quickly identify problems and detect outbreaks while they’re still quite small. In partnership with the CDC, FDA set up a successful module for WGS of Listeria and the agency hopes to expand the model for use with other pathogens.
  • Nutrition (Not just what consumers are eating, but how much of it): The move that declared partially hydrogenated oils as no longer GRAS with compliance required by 2018.  The agency also issued a final guidance on menu and vending labeling in May, issued levels for arsenic in infant rice cereal, made determination for folic acid fortification in corn/masa, made revisions to nutrition facts labels that takes effect in 2018, issued a draft guidance on voluntary sodium reduction, and will continue to exam the terms “natural” and “healthy”.
  • Genetic engineering. FDA approval of GE salmon following one of the longest reviews in the history of FDA (20-year review), along with issuing voluntary labeling guidance.
  • Monitoring antimicrobial resistance through NARMS  (National Antimicrobial Resistance Monitoring System). FDA will be collecting antimicrobial sales by species and, in cooperation with USDA, hopes to release farm-based data about antimicrobial use at the farm level.

Ostroff emphasized FDA’s strategic 10-year plan, released this year, pointing to public health as a first priority, maintaining partnerships as a key to success (including re-establishing overseas offices), continuing research as a foundation, and maintaining transparently.