Tag Archives: Preventive Controls

Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC
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Managing GFSI Certification a New FSMA Requirement

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

Compliance to FSMA requires companies to meet existing program requirements and new ones being published or face regulatory consequences. A part of FSMA also requires that companies follow established food safety plans, which includes GFSI certification.

With these changes, GFSI-level programs must integrate into an aligned Food Safety Management System (FSMS) and strategy. Key considerations include sustainability, multi-year planning, effective organizational structures and expectations, well-defined roles and expectations, compliance, and business objectives.

The value of GFSI certification depends on how the company uses its organizational resources to maximize return on investment, while meeting the changing FDA requirements. Effective management of a GFSI-certified FSMS can have a significant impact on FDA/FSMA compliance. The risk of not meeting established programs while implementing new FSMA programs must be measured, and attention must be given to addressing FSMA compliance, while maintaining established programs.

Complying with FSMA Food Safety Programs
The implementation of FSMA-compliant programs requires having an established GFSI FSMS and demonstrating conformance with one’s own policies. Programs must be maintained and improved as the FSMA requirements are developed and implemented. Each of the GFSI schemes has been vetted to meet a significant level of FDA/FSMA requirements—a key benefit to these industry programs.

Developing a compliant FSMS with proper alignment of your existing programs to FSMA must be assessed. For example, companies with more than 500 employees must include requirements in their programs for the FSMA Preventive Controls rule, which is set for compliance September 19, 2016. In this regard, registered food facilities must evaluate and implement preventive control provisions and meet the requirements by the approaching deadline. This requires effectively updating current programs, establishing key imperatives including cGMPs (Section 117), identifying a Preventive Control Qualified Individual (PCQI), and implementing a Food Safety Plan.

The following areas are all included under the FSMA requirements:

  • cGMP, Controls and Preventive Controls. Must be identified, modified, and implemented to further minimize or prevent the occurrence of hazards based on Section 117 requirements.
  • Food Safety Plan, Hazard Analysis, and HACCP. Companies must identify and evaluate changes in their existing programs to include FSMA Preventive Controls.
  • Qualified Individual. Must be trained with authority to oversee Preventive Control program aspects, developments and impacts.
  • Written Programs and Documentation. Up-to-date GFSI-level FSMS provides documented programs, procedures, and records for meeting requirements under FDA/FSMA.
  • Management & Monitoring. All controls, including under FSMA and existing GFSI-level, must be monitored, validated, and verified for effectiveness.
  • Management of Corrective Actions. Procedures including traceability response for addressing failures of procedures, GMPs and controls must be under management review and confirmed for prevention of adulterated food from entering commerce.
  • Recordkeeping. Records must be complete and accurate for all food production and safety activities and kept for two years, including the testing level verification of all programs under FSMA and GFSI-level programs.

Self-Diagnostic Assessment Tool

The following self-diagnostic assessment tool can help organizations better determine their current state of planning when it comes to GFSI-level programs meeting FSMA. To complete your own planning assessment, review your progress compared to the questions in Table I.

FSMA, GFSI
Table I. Kestrel Management’s self-diagnostic tool can help a company assess its level of FSMS and GFSI preparedness for FSMA compliance.

Get Compliance-Ready

Companies must have their existing food compliance and GFSI programs in good standing 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.

How Not to Fail at Online Food Safety Training

By Maria Fontanazza
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Training plays a crucial role in the FSMA Preventive Controls rule. As online learning becomes a more integral part of employee learning, companies may want to reexamine the methods they use to boost more effective outcomes. And for companies that currently use face-to-face training, investing in a virtual approach could encourage a more proactive employee learning experience.

Kathryn Birmingham, ImEpik
“Industry research tells us that company leaders want training that is relevant, in which employees can apply skills right away.” – Kathryn Birmingham, ImEpik

“Under the [Preventive Controls for] Human Food rule we have legal roles that didn’t exist before—we must create smarter career pathways for these new positions and responsibilities, such as the Qualified Individual under the PCQI, the Preventive Controls Qualified Individual, and the auditor,” says Kathryn Birmingham, vice president, research and development at ImEpik. “The compliance required for these new positions is a great opportunity to use innovative and scalable training models. This becomes even more important for ROI (return on investment) in training, when turnover is likely or when companies want to attract new talent into the food safety industry.”

In a Q&A with Food Safety Tech, Birmingham explains how companies can navigate some of the additional training requirements under FSMA and how interactive online learning may offer both employees and companies more successful results.

Food Safety Tech: What employee training challenges do today’s food companies face?

Kathryn Birmingham: As an educator, business owner and researcher who has designed certification and degree programs for workforce training in several industries, I see [that] the food manufacturing industry must move from lifetime experience training to training standards. For the first time, the evidence of QI training and PCQI credential are owned by the person as they move from company to company.

Food companies need a cost-effective training system that can assess knowledge, skills and competency standards. Industry research tells us that company leaders want training that is relevant, in which employees can apply skills right away. They want to be able to test the knowledge of persons in these new roles who are accountable for regulatory compliance. Thus they expect valid assessments in their certification training.

The demand is for smarter pathways to reach these new legal roles in the legislation for the QI and PCQI. Assisting in this area, we need to remember that food manufacturing companies view their number one job as making food, not completing paperwork or digital documentation, so when it comes to FSMA we have to come up with relevant training that can be applied right away.

FST: In what areas do you think companies are unprepared for FSMA implementation and compliance?

Birmingham: Companies seem to be least confident in terms of training in a few areas: For the legal role of the PCQI, they seem to be least confident about the record keeping requirements and foreign supplier verification areas.

For the role of the QI, standardized training doesn’t exist, but we know from the PCQI training that if the QI is required to implement the food safety plan under the PCQI, then QIs must understand components of the food safety plan and the hazard analysis. So it follows that the QI must also understand some scientific and regulatory factors related to the preventive controls along with the new language that must be used in the food safety plan and documentation.

FST: What tools or technologies should companies leverage?

Birmingham: Research and successful practice in workforce training tells us a few things. In order to speed learning and verify the trainee’s learning, knowledge and competencies, we recommend instructional methods that are immediately relevant, engaging and motivating. Effective training for food safety regulatory compliance helps the learner with stronger critical thinking for decision-making and encourages the learner to apply the skills right away. Modular instruction allows time for practice and reflection while increasing the odds of retention of the material. Relevant work simulations can teach technical and scientific knowledge as well as communication skills.

We recommend online training that demonstrates proficiency and mastery rather than passive learning. The learner must engage and practice what they’re learning, show an understanding, practice critical thinking, and pass valid assessment exercises.

Food safety online training, ImEpik
ImEpik’s survey aimed to understand expectations as well as effectiveness of online training. Infographic excerpt courtesy of ImEpik.

FST: Do you think a lot of passive learning is happening in the food industry?

Birmingham: [Birmingham cites a food safety online training survey conducted by ImEpik earlier this year; see Table I.] Survey responses from a sample of 140 companies are telling us that they’re not satisfied with lack of engagement in training offerings. Those overseeing training would like to see more valid assessments. In terms of passive learning, they don’t want to click through voice-over narration for training or have face-to-face training that is lecture style without a lot of engagement. They want to understand the learning outcomes and what they should be getting out of the curriculum as they move through the training.

Preference for Specific Online Learning Attributes
I Dislike It I Can Tolerate I Expect It I Like It
Multi-languages  10%
Valid Assessments  —  91%
Research-based Instructional Methodologies  —  79%
Learner Engagement  —  —  77%
Interactive Activities  —  —  73%
Certificate of Completion  —  65%
Supplementary Manual  —  55%
Animation  —  —  35%
Learning Analytics  —  —  55%
Table I. Results from ImEpik survey about food safety online training. While animation and learning analytics are not as expected in  online learning, these attributes are an important part of simulating the work experience in order to apply new knowledge, test specific content areas for clarity and assist the learner in remediation as needed. Data courtesy of ImEpik.

In the 2015 survey, 73% said they expect interactive activity in training while 91% expect valid assessment. People are looking for feedback as they progress through training. In the end they want to have the ability to prove what they know and can do.

With the emphasis now on FSMA, for companies to develop their entire food safety team, we need to rethink training and remember that it is possible to look at other industries and see what they’ve done with these career pathways for new roles that have been legislated. We can compare online training that is accessible anywhere and agile enough to train for new concepts quickly. Science and GMPs change. This is where a tool like online learning—not only full-course certification courses but also micro-learning modules—can really help the industry. And in the long run, it could be a better return on investment than face-to-face and long-term experiential learning.

Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC
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FSMA Preventive Controls: Are You Prepared?

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

Compliance to FSMA has presented a new and difficult challenge for industry, the public and the FDA since it passed on January 4, 2011. With compliance dates for the initial FSMA rule—Preventive Controls—coming in September 2016, food sites must establish plans now to meet the impending deadline.

Complying with the Preventive Controls Rule

The Preventive Controls Rule was published September 17, 2015, with the compliance date for registered companies (more than 500 employees) scheduled for September 19, 2016. The compliance date is one year later for companies with fewer than 500 employees, unless otherwise specified under FSMA.

Under the FSMA rules, registered food facilities must evaluate and implement preventive control provisions and meet the requirements and the approaching deadline. The most urgent concerns for companies subject to the Preventive Controls Rule include developing a Preventive Controls Program, identifying a Preventive Control Qualified Individual (PCQI), and implementing a Food Safety Plan.

The following areas are all included under the FSMA Preventive Controls Rule:

  • Hazard Analysis. Companies must identify and evaluate known and reasonably foreseeable hazards.
  • Preventive Controls. Preventive controls must be implemented to significantly minimize or prevent the occurrence of hazards.
  • Monitoring. Preventive controls must be monitored for effectiveness.
  • Corrective Actions. Procedures for addressing failures of preventive controls and prevention of affected food from entering commerce are required.
  • Verification. Facilities are required to verify that preventive controls, monitoring and corrective actions are adequate.
  • Recordkeeping. Records must be kept for two years.
  • Written Plan and Documentation. A written plan must document and describe procedures used to comply with requirements.
  • Qualified Individual. A Qualified Individual who has been adequately trained must be present at the facility to manage the preventive controls for the site and the products processed and distributed at/from the site.

Failure to implement Preventive Controls (a.k.a., Hazard Analysis and Risk-based Preventive Controls (HARPC)) for qualified sites may result in fines and possible jail sentences.

Self-Diagnostic Assessment Tool

The following self-diagnostic assessment tool can help organizations better determine their current state of planning for FSMA compliance (see Table I). To complete your own planning assessment, review your progress compared to the questions below.

Table I. Kestrel Management’s self-diagnostic tool can help a company assess its level of preparedness for FSMA compliance.
Table I. Kestrel Management’s self-diagnostic tool can help a company assess its level of preparedness for FSMA compliance.

Get Compliance-Ready

Companies must have their training, planning and development underway to comply, 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 the preventive controls program—and change “No” responses into “Yes” responses that promote best practices for FSMA compliance.

Debby Newslow
FST Soapbox

FSMA’s Preventive Control’s and Current GFSI-Approved Scheme Compliance

By Debby L. Newslow
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Debby Newslow

Confusion reigns in many organizations and especially with our food safety and quality professionals, as we debate and attempt to decide how best to address the requirements of FSMA. With the first compliance date of September 2016 drawing near, companies are feeling increased pressure to take action. As many are already accredited to a GFSI-approved food safety scheme such as SQF Level 3, BRC, Primas, IFS or FSSC 22000, often the question is, how does my current system fit into FSMA, and where do I need to make changes? The undercurrent to this question is the implication that changing the system to fit FSMA will cause it to no longer be tailored for the desired GFSI food safety scheme, and that a change could cause issues with those audits (which are crucial for purchasing, marketing and sales).

The Food Safety Consortium will discuss critical industry issues, including FSMA compliance. The event takes place in Schaumburg, IL | December 5–9, 2016 | LEARN MOREAs with so many of our industry challenges, there is no easy and prescriptive answer to these questions. Each organization has to make the decision for their own system based on their individual hazard analysis, risk tolerance and resources. Some over-arching themes begin to emerge, which may be analyzed to assist the decision makers in the creation of a road map to FSMA compliance.

During our FSMA Preventive Control Qualified Individual (PCQI) training courses we are repeatedly asked, “What qualifies as a preventive control? Are our critical control points (CCPs) automatically a preventive control? How about our operational prerequisite programs (OPRPs)—are these PCs also?” While there is no easy answer (yes or no), there are some important things to keep in mind that can help in the decision.

The official answer is that a preventive control should be any point in the process where, with a loss of control, it is reasonably foreseeable that a significant food safety hazard either will occur or has an increased likelihood of occurrence. Remember this is intended to be a single point in the process, not the entire process. For example, the sanitation program may be managed as a prerequisite program; however, there may be a point in the process that requires special sanitation attention and without it, there is a reasonably foreseeable likelihood of a hazard.

Thinking about the concept, a logical conclusion is that a loss of control leads to a significant food safety hazard or, at the very least, increases the likelihood of said hazard. It follows that a loss of control would beget the need for a withdrawal if the product had already left the organization’s control. Therefore, one should only designate a point as a preventive control if the implications of conducting a recall in the event of failure have been analyzed as part of the risk assessment. The organization must be fully prepared to conduct such a recall in the event of failure.

The FSMA Preventive Control regulation (§21CFR117.135 – Preventive Controls) requires a recall program only if there is a preventive control identified in the process. Of course, any food processing organization would be remiss if they did not have an effective recall program defined and tested by regular mock recalls. Waiting for a true recall is no time to find out that your program has issues.  Even without a preventive control, what happens if a supplier contacts the processor with an issue that requires a recall?

Through the evolution of compliant and mature food safety management systems, it is common for an organization to initially identify multiple CCPs and then, through data collection and process improvements, slowly reduce the CCPs to control points managed through OPRPs or PRPs over time.  So, should an OPRP (Operational Prerequisite Program – ISO 22000:2005 Section 7.5) also be designated preventive control?  This is perhaps one of the grayest of gray areas in this arena.  A deviation in a preventive control, if the product has left the organization’s control, requires a recall.  A recall for a deviation in an OPRP is not absolute, and it is actually handled by the food safety team and management on a case-by-case basis, depending on the risk.  In addition, although identified when possible, a critical limit is not required for an OPRP (ISO 22000:2015 Section 7.5).  Parameters are required for a preventive control.

There really isn’t one answer that fits every situation, but it is important to remember that the requirements for FSMA Preventive Controls regulation (§21CFR117.135) are designed for those operations that in the past have not had the opportunity to define, implement and maintain a food safety program—one that includes a hazard analysis based on HACCP guidelines (Codex Alimentarius Commission [Annex to CAC/RCP 1-1969, Rev. 3 (2003)]) and/or a GFSI-approved food safety scheme.  Personally, we feel that if an organization has evaluated their process in compliance with a GFSI-approved food safety scheme, then any reasonably foreseeable hazards have been identified and addressed through a control point such as a CCP, OPRP or PRP. However, that said, upwards of 90% of recalls are linked to either ineffective or nonexistent PRPs such as allergen mislabeling, which accounted for 53% of all recalls last year. Thus, it is imperative that we evaluate all aspects of our processes with the same scrutiny that we do our microbial pathogen and metal control programs, which are common CCPs in today’s world of food safety.

Risks must be evaluated through an effective risk assessment based on science and facts. We start almost all of our workshops with the great American Society for Quality (ASQ) video: Cost of Poor Quality. This highlights the lack of an effective risk assessment performed on January 28, 1986, related to the launch of the Challenger. Unfortunately, emphasis was not on the fact that the engineers presented about the lack of cold temperature stability of critical O-rings, but rather on the fact that the launch had already been postponed for two days, and there was intense media and political hype surrounding the event. An effective risk assessment must be based on facts and objectivity, not on our feelings about what we want or need the decision to be.

FSMA PCQI training stresses the use of reliable and credible resources such as academia, trade organizations and process authorities. The internet itself can also be a valuable resource. Jon Porter stated in 2004, “HACCP, as we know it, would not exist without the internet.”  (If Jon could only see us now.)  However, again, we must be sure we are choosing credible information from the internet. We all know that we can usually find any answer we desire on the internet, but is it credible and accurate?

Competent industry sector-experienced consultants may also be good options if the organization ensures their credibility. Sometimes, a set of independent eyes can be just what the doctor ordered. Even in cases where the organization has a fully qualified team that is perfectly capable of managing the food safety program on their own, the right external resource (i.e., consultant) may provide an additional, independent viewpoint to your process. A friendly debate with an external resource can oftentimes open a whole new vista of previously unconsidered possibilities for the team.

The FSMA Preventive Controls regulation (§21CFR117.135) states that “each organization is required to have a PCQI that has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety system”. What qualifies an individual to be qualified through job experience is not specifically defined but is judged by the effectiveness of their food safety program. However, if FDA visits the facility and asks for the PCQI and no one has taken an FDA-recognized course—but there is someone that the organization has identified as qualified—this has the potential to start the visit off with a negative focus. We urge each organization to send two food safety associates to an FDA-recognized FSMA PCQI training course regardless of their background (this provides a back-up person in case the primary representative is ill, traveling for business or pleasure, wins the lottery, or otherwise leaves the company, etc.). This provides a strong foundation for the future, as ownership of the system is always crucial to not just surviving an inspection, but excelling—and as food safety professionals that is an idea we can all support.

 

Rachel Montgomery

Keep Calm and Be Sure You Have a PCQI—Soon!

By Rachel Montgomery
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Rachel Montgomery

You will hear some new abbreviations being tossed around in questions by executives in food manufacturing and processing these days. “Do I need a PCQI? Who is my PCQI? What is a PCQI?”

Strangely, many of these executives do need a PCQI, and they need one very soon. A PCQI is the “Preventive Controls Qualified Individual” needed to oversee implementation of the HARPC rule under FSMA. Last September FDA published the final rule “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.” Unless a food manufacturer is specifically exempt, the date for compliance with implementation of the rule’s preventive controls portion is September 19, 2016. A facility’s PCQI is responsible for overseeing the implementation process. For companies that have yet to prepare for compliance, the good news is that several organizations, such as the Food Safety Preventive Controls Alliance, offer training to meet the requirement for having a PCQI.

For large companies (those with more than 500 employees), time is of the essence to meet the September 19 compliance date; for companies with less than 500 full-time-equivalent employees, you have more time to prepare, with September 18, 2017 being the compliance date.

Whether your due date is this year or 2017, your food safety plan is the primary document that guides your preventive controls food safety system. It must be developed using a systematic and risk-based approach that uses scientific principles to identify the hazards that require preventive controls to prevent foodborne illness or injury. It is most effectively prepared not only by a single PCQI but also a cross-functional food safety team that includes individuals with executive support and leadership. In addition to including the hazard analysis in which you must analyze for hazards requiring a preventive control for your product(s), your food safety plan must have preventive controls for your process and for food allergens, sanitation, supply chain and any other appropriate areas where you identified that preventive controls were needed.

Further, your food safety plan must include a recall plan, procedures for monitoring, corrective action and verification when a hazard requiring a preventive control is identified, along with science-based validation for process preventive controls. Of course, Good Manufacturing Practices (GMPs) and other prerequisite programs must be in place to provide a solid foundation for your food safety plan. And there’s more news: FSMA includes significant changes in the GMPs. For example, all formerly non-binding provisions are now binding, including education and training. One of the new GMP requirements is cleaning of non-food contact surfaces “as frequently as necessary” to protect against allergen cross-contact and contamination of food contact surfaces and food packaging.

Back to the possibility that you may qualify for a specific exemption, if you heard that processors subject to the low-acid and acidified canned foods regulation are not subject to the preventive controls rule, the exemption is only for hazards that are microbiological. For physical and chemical hazards, including allergens, a hazard analysis must be conducted to determine whether hazards are an issue and whether preventive controls are needed. This analysis must be documented, even if you determine that no preventive controls are needed. And if preventive controls are needed, they must be developed and documented with verification and possibly validation as previously described. Of course the new GMPs also apply to low-acid and acidified canned food manufacturers.

If you heard that warehouses are in the clear due to a specific exemption, there is more to the story. Only facilities such as warehouses that store strictly unexposed packaged materials for which refrigeration is not required are exempt from preventive controls. Facilities that store raw agricultural commodities that are fruits and vegetables are not exempt from hazardous analysis and risk-based preventive controls. All of these facilities, and even those subject to seafood and juice HACCP and not required to do preventive controls, are not exempt from updated GMP requirements.

Take the obvious first or next step for your organization’s compliance with FSMA: Ensure you have a PCQI and start working on your hazard analysis and food safety plan now.

Kassy Marsh, Techni-K
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The Solution to Combining a HACCP & HARPC Plan

By Kassy Marsh
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Kassy Marsh, Techni-K

Since the publication of the FSMA Preventive Controls Rule for Human Food, the term HARPC has become a common way of describing the type of food safety plan that is needed to comply with the requirements. On first glance its similarities to HACCP could possibly lead one to believe that the requirements for both systems are aligned. But beware, there are a number of fundamental differences and one main contradiction in the requirements, which requires a clarity of understanding when trying to amalgamate the two systems.

With the introduction of the FSMA Preventive Controls Rule, food facilities that have HACCP systems are now faced with the difficult task of trying to adapt their current food safety system to meet the HARPC requirements. These facilities will continue to be required by local law in the countries where they export to, by their customers and by standards such as those recognized by the GFSI to adhere to the HACCP principles. A straight swap from HACCP to HARPC is not going to be an option for many businesses. Therefore, a combined approach is required, one that meets both sets of requirements and has a clear, practical and effective methodology.

Structure of the Controls

One of the consequences of combining the requirements of HACCP and HARPC is that all of the control principles need to come together and work as one. For this reason, the distinctions between pre-requisite controls (PRCs), preventive controls (PCs) and critical control points (CCPs) must be fully understood.

  • Pre-requisite control: A facility-wide generic control, not specific to one particular process step
  • Preventive control: A control that prevents or significantly minimizes the hazard
  • Critical control point: A control that eliminates or reduces the hazard to an acceptable level

There is a hierarchy to the controls, with PRCs being the building blocks for facility-wide general controls; PCs are more specific controls that are typically associated with a particular step in the process; a CCP is one that is above and beyond a PC and is critical to the safety of the food (see Figure 1).

Figure 1.
Figure 1.

A PC is one that either prevents the hazard from occurring in the first place, or if the hazard has occurred, it recognizes it and minimizes the impact of the hazard by controlling it and not allowing it to be released as product.

A CCP controls a hazard that is inherently expected in the product by eliminating it or reducing it to a level at which it is safe.

Key Challenges

There are a number of differences between the requirements of HACCP and HARPC. The PC Rule is not as specific or detailed in the way in which the plan should be documented or designed, as the principles laid out in the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) or Codex Alimentarius. However, the FDA may not have directly stated that certain elements such as product description, intended use or intended user must be included, but they do elude to the fact, as the hazards that must be assessed would require this information to be understood and fed into the system. This means that in order to comply with both systems, the principles of HACCP must be adhered to as well as those of HARPC, so elements such as process flow diagram will still be required.

The key difference between the systems related to how significance is determined within the risk assessment. Both systems require a risk assessment that takes into account the severity of the hazard and the likelihood of the hazard occurring. The results of this should determine if the hazard is a significant food safety risk, where it is, and whether a PC is required. Hazards that are not significant would need to be managed through the application of PRCs.

The difficulty enters the picture when assessing the likelihood of the hazard occurring, as the two sets of requirements contradict each other:

The PC Rule asks for the likelihood to be determined in the absence of any controls.

HACCP principle states that the likelihood should be determined, taking the controls into account.

It is acceptable to HACCP principles to follow the requirement for HARPC and carry out the assessment in the absence of any controls, however there are consequences in doing so. The number of significant hazards that will be produced will be substantially higher than in a traditional HACCP plan. Each of these hazards will need to be controlled through a PC, and the CCPs will need to be determined from this set of PCs. Using the typical CCP decision tree is not a practical solution, as the result will likely mean that most of the PCs become CCPs. Nobody wants to go back to the days when facilities had many, many CCPs, as this produces an unmanageable and ineffective food safety system.

A new methodology is required for the determination of CCPs—one that is clear and does not contradict the HACCP principles.

The Benefits of HARPC

Although the introduction of HARPC makes designing and developing a food safety plan more complicated, it does have its benefits. Over time, as pre-requisite programs have developed, the number of hazards that are managed by PRCs have grown—to the point now where most facilities only have a handful, if not one or two, CCPs.

Through a HACCP plan, even very significant food safety hazards can be managed by the PRCs. These significant hazards are therefore managed, just the same as insignificant or low-risk hazards. This may be the reason that the most common recalls and withdrawals today are due to lack of control from pre-requisites.

By introducing the new tier of PCs and assessing significance without taking any controls into account, we mitigate this problem. Ensuring that the key food safety hazards, which perhaps are not critical, are managed through the application of PCs and they thus receive additional focus.

Resources

  1. “Comparing the Standards for HARPC”. Techni-k. Retrieved from http://www.techni-k.co.uk/comparing_the_standards_for_HARPC.
  2. Marsh, K. (2016). Combine Your HACCP & HARPC Plan.
FSMA, Food Safety Tech, FDA

Draft Guidance for Qualified Facilities under FSMA PC Rules Released

By Food Safety Tech Staff
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FSMA, Food Safety Tech, FDA

Today FDA published a draft guidance to help qualified facilities in complying with the FSMA Preventive Controls (PC) for Human and Animal Food rules. Businesses that are defined as qualified facilities are subject to modified requirements of the PC rules, which can be met by submitting a form to FDA confirming that the site is implementing PCs to address hazards related to its food or is in compliance with non-Federal food safety laws and regulations.

The draft guidance, “Qualified Facility Attestation Using From FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food)” discusses how to determine whether a business meets the “qualified facility” definition and how to submit the form that demonstrates this status.

The Federal Register is scheduled to publish the document on May 16, at which point the draft guidance will be available for public comment for 180 days.

EMAlert, Economically motivated adulteration

Food Fraud: Perps Two Steps Ahead, Innovation Needed to Keep Up

By Maria Fontanazza
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EMAlert, Economically motivated adulteration

Economically motivated adulteration (EMA) has considerable economic ramifications, impacting businesses from a financial and liability perspective, posing dangers to consumers, and eroding product confidence. One of the biggest issues with monitoring the volume and type of adulterated products is the fact that the landscape of food fraud is ever changing. “The perpetrators are always two steps ahead, so innovation is needed to keep up,” said Jeff Moore, Ph.D., director of science, food program at U.S. Pharmacopeial Convention (USP), at the GMA Science Forum last week.

GMA and Battelle have teamed up to launch EMAlert, a tool that companies can use to quantitatively assess the vulnerability of their supply chains to EMA. The secure, cloud-based platform comes with 50 commodities off the shelf (including spices, grains, dairy, seafood, meat, oils, fruits, veggies, and food ingredients). It was developed fairly rapidly (Battelle, which serves as the technology provider, started development at the beginning of this year) and still needs to be validated; full validation will be presented at the IAFP meeting this summer. And if EMAlert lives up to its potential, it could help companies be more nimble in monitoring and acting on threats in their supply chain.

The purpose of the tool is to generate quantitative vulnerability results that allow people to make actionable decisions based on numeric values. As such, it has been designed to be dynamic and customizable, since every company has its own risk tolerance. In addition, it looks at real-time environmental changes, because you can’t have a static tool to monitor vulnerability when it’s always changing, said Joseph A. Scimeca, Ph.D., vice president, global regulatory & scientific affairs at Cargill, Inc.

EMAlert, Economically motivated adulteration
A screenshot of EMAlert

“The EMA threat is changing,” said Ashley Kubatko, principal research scientist at the Battelle Memorial Institute. “A static assessment is only a snapshot in time.” EMAlert pulls live, automated data that takes into account economic drivers (value, volume, and scarcity of product), historical drivers (how often has product adulteration occurred in the past, geopolitical stability), and ease drivers (how frequently the commodity is tested; whether there are government regulations around the commodity group; how often the product changes hands or is repackaged). Data is pulled from several databases, including FDA, UN Comtrade, USP, Quandi, and Transparency International.

When creating the tool Battelle borrowed from its approach in working with the U.S. Department of Homeland Security to develop models that predict terrorist decision making and used the same mathematical methodology, providing a predictive model of fraudster behavior. Keeping in mind that perpetrators are also constantly monitoring how law enforcement and industry is keeping track of their strategies, EMAlert not only requires a subscription, but Kubatko says that Battelle will also be monitoring its users to ensure there is no suspicious activity within EMAlert.

In the Food Lab

New Dynamics in Environmental Testing

By Erin Dreyling, Ph.D
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Recent recalls and outbreaks associated with Listeria coupled with FDA’s finalization of the FSMA preventive controls rule have heightened the industry’s need to focus on environmental testing programs. The need for a preventive control program with higher resolution is especially highlighted by the government’s increasing use of whole genome sequencing data to more rapidly link human illness to food processing establishments. I work with many customers who simply do not recognize all of the factors that influence their ability to detect Listeria in environmental samples. For many, an environmental sample is collected, shipped to a third-party lab, results are received within two to four days, and few questions asked. Most companies have not invested the time and resources needed to truly understand how each component of an environmental sample impacts their ability to detect Listeria. So what factors should be considered to maximize Listeria detection in the plant environment?

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Listeria is inherently a hearty organism that can withstand highly adverse conditions in the plant environment. It is able to survive and grow across a wide range of temperatures, including refrigeration, and it is more tolerant to heat than Salmonella and E. coli. Additionally, the organism survives across a wide pH range, including extended periods in highly acidic conditions, and can survive food processing and preservation with up to 25.5% salt. These traits may result in highly injured Listeria being collected in environmental samples, and requires optimization of the sample collection and analysis process in order for detection and culture confirmation to occur.

Sanitation Programs May Not Destroy Listeria

Sanitation practices are intended to destroy Listeria in the plant environment, but not all sanitizers will be 100% effective. In some cases, sanitizers may not fully kill Listeria, leaving highly injured Listeria that may require an extended lag phase in order for growth and detection during testing. Sub-lethally injured Listeria remains a food safety concern, as the bacteria maintain the ability to recover and flourish in a nutritive environment. Additionally, Listeria readily forms biofilms in the plant environment, which many traditional sanitizers do not effectively remove. Biofilms in the plant environment may maintain low levels of Listeria that may be challenging to detect without the use of a sensitive detection method.

Sample Collection: Choose the Right Tool for the Job

The neutralizing and nutritive capacity of the collection media used with the collection device can have a significant impact on the ability to resuscitate, detect and culture stressed Listeria. When selecting a collection media, it is important to ensure that the media will effectively neutralize the sanitizers used in the plant environment. For instance, peroxyacetic acid and quaterinary ammonia-based sanitizers will not be neutralized well by commonly used collection media such as Neutralizing Buffer or Letheen Broth. Neutralization of the sanitizer in environmental samples is important in order for resuscitation and growth of any Listeria present within the sample. Additionally, use of a collection media that contains nutrients to begin the resuscitation process for Listeria immediately upon collection is also important for detection and culture confirmation of Listeria in samples. Collection media such as Neutralizing Buffer contains monopatassium phosphate, sodium thiosulfate, and aryl sulfonate complex intended only to neutralize sanitizers. Conversely, D/E Broth and HiCap Broth have components to nourish Listeria and facilitate resuscitation in addition to neutralizing sanitizers.

Enrichment Media Determines Recovery & Growth

Enrichment media plays a major role in the speed of recovery and growth of Listeria in environmental samples. Medias that facilitate faster recovery of injured Listeria allow for shortened lag phases facilitating more rapid growth. Enrichment media that facilitate faster recovery and growth allow Listeria to reach the limit of detection for screening tools more quickly. When paired with a highly sensitive method, enrichment media, which foster greater Listeria growth and recovery, can allow for significant reductions in time to results for screening methods. Additionally, faster recovery and growth of Listeria due to enrichment media can increase the likelihood of culturally confirming Listeria found at low levels pre-enrichment.

Not All Detection Methods are the Same

The ability of a detection method to find Listeria in an environmental sample is impacted by two factors: 1) method sensitivity and 2) method robustness in the presence of sanitizers. The more sensitive a rapid test method, the greater the chance of finding low levels of Listeria in an environmental sample. Low levels of Listeria in environmental samples are likely due to the injured state of Listeria in the plant environment post sanitization. Immuno-based rapid methods have a sensitivity of 105–106, DNA-based methods have a sensitivity of 104–105 and RNA based methods have a sensitivity of 102–103. Using an RNA-based method offers 1 to 2 logs greater sensitivity and greatly increases the chance of finding low-level Listeria.1 This can be particularly true when sampling conditions such as collection media or enrichment media are less than optimal for the neutralization of sanitizers and growth and recovery of Listeria.

Another important factor that influences a test method’s ability to detect Listeria in an environmental sample is the method’s ability to amplify and detect the organism in the presence of sanitizers. Most molecular-based methods do not include a sample clean up step resulting in sanitizer being present during the amplification step. For some methods, sanitizers may inhibit amplification, resulting in indeterminate or false negative results.

Confirmation Requires Optimization of the Sampling Process

The ability to culturally confirm a Listeria sample that screens positive is influenced by the entire environmental sampling process. In order to culture confirm samples with highly injured, low-level Listeria, it is necessary to optimize the sample collection media, enrichment media, and confirmation process to provide the greatest likelihood of culture recovery. If Listeria is not adequately resuscitated and able to achieve sufficient growth, the level of Listeria present in the sample post-enrichment may be below the limit of detection for culture. The likelihood of culture confirmation can be increased by incorporating steps such as a secondary enrichment or concentration via IMS capture. Culture confirmation for samples that screen positive on a rapid method can be especially challenging if a highly sensitive test method is used for screening that may detect Listeria at lower levels than culture. Thus, optimizing the environmental sample program is especially important if confirmation of screening results for highly sensitive methods is desired.

Method Sensitivity and Increased Positivity

Employing a highly sensitive screening tool for environmental samples provides a better lens to view risk within the food safety processing environment. Many companies fear that a more sensitive method will result in significant increases in positivity and cost for increased sanitation. In working with customers who have moved from immune-based methods to a highly sensitivity molecular method, I’ve observed an initial increase in positivity followed by a leveling off of low-level positivity after enhanced interventions are taken in the plant. Companies that proactively seek out and destroy Listeria in their plants are then able to maintain low level rates of positivity with routine cleaning measures, while also maintaining the confidence that they are using the best tool available for Listeria monitoring.

Understand Your Risk & Establish a Culture of Food Safety

It is important for food safety professionals to fully consider the hidden risks that may exist in their plant environment due to the environmental sample process masking the true presence of Listeria. Each component of the environmental monitoring process, sanitizer, collection media, enrichment media, detection method and culture process plays an important role in a company’s ability to be able to detect and culture confirm Listeria in the plant environment. Optimizing each step within the environmental sample process allows a company to be proactive instead of reactive. This approach creates a company culture of food safety that can seek out, detect and destroy Listeria in the plant environment, can significantly mitigate risk. The good news is that by incorporating the right food safety culture and making data-driven choices, today’s manufacturer can achieve both short-term dividends of risk reduction as well as a long-term elevation of control of its process.

Reference

  1. Culture Shift: The New Dynamics of Listeria Environmental Control and Testing. Roka Bioscience, Webinar.

Specific Training Required Under FSMA: A Look at Each Rule

By James Cook
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All seven core rules of FSMA require general training of individuals or employees and qualified individuals requiring education, training or experience to perform specific tasks. By including training in these regulations, the FDA has made specific training mandatory.

Training Required by FSMA Final Rules

In the current Good Manufacturing Practices (cGMP) and preventive control rules, as per 21 CFR 117.4 and 507.4, all individuals engaged in the manufacturing, processing, packing and holding of food must have the education, training or experience to perform assigned duties and must be trained in the principles of food hygiene and food safety. However, the preventive controls qualified individual (PCQI) and qualified auditor, to rules 21 CFR 117.180 and 507.53, can be an individual who has successfully completed a class equivalent in curriculum to that recognized by the FDA, or have the necessary job experience. In both cases, the training must be documented, including the date of training, type of training and those personnel trained.

This means that all employees are to be trained in food hygiene and food safety to at least the standard presented in the regulations and more specifically as per the cGMP requirements. Additionally, individuals who are responsible for a specific critical control point will still need to be trained in HACCP. However, this will probably not be sufficient for an employee responsible for preventive control, as he or she may require training in Hazard Analysis Risk-Based Preventive Control (HARPC), or training specific to the area in which the employee is involved (e.g., allergens, sanitation, supply chain or recall programs, or preventive controls).

For the preventive control qualified individual and qualified auditor, the training needed may be that of the approved FDA curriculum, as developed by the Food Safety Preventive Control Alliance (FSPCA). Although this training course is not a regulatory requirement, FDA inspectors and other regulatory personnel who are auditing facilities will have completed this training, meaning qualified auditors will be expected to have this training, and eventually preventive controls qualified individuals (PCQIs) will be expected to do so too. The qualified auditor and a PCQI will still require the education, experience and other training to perform the specific job duties as listed in the regulations. Unfortunately, it is likely that neither the industry nor the government will have enough lead instructors ready to train everyone who would want or need to be trained before the compliance dates become effective. Additionally, this training course is not yet available for animal food, and the industry has been informed by FSPCA that a Foreign Supplier Verification Program (FSVP) training module will be added to the training course. The FSVP is discussed in the Supply-Chain Preventive Control module, and the fact that there are some similarities between these regulations helps individuals involved in the FSVP program, or in auditing it.

In the produce safety rule, training requirements are listed in subpart C 21 CFR 112.21, 112.22, 112.23 and 112.30. Personnel who require training are those handling covered produce and their supervisors. As with the cGMP and preventive control rules, the principles of food hygiene and food safety must be taught to these personnel. More specifically they must learn how to identify an ill or infected person, and be taught about microorganisms of public health significance, such as Salmonella, Listeria and E. coli O157 on food contact surfaces. Additionally, personnel who harvest covered produce must be trained in recognizing produce that is contaminated with known or reasonably foreseeable hazards to ensure it isn’t harvested. These personnel must be trained in the use of harvest containers and equipment to ensure that they are functioning properly, clean and maintained, and to identify when they are not. At the same time, employees must be trained in correcting any issues or in reporting them to a supervisor in order to have them corrected. All this training must be documented in the same way as the cGMP and preventive control programs.

Unlike the cGMP and preventive control rules, the produce safety rule’s requirement to have a qualified individual, supervisor or responsible party on each farm that has completed a recognized FDA course, or equivalent, is not optional. This course will be available through the Produce Safety Alliance and is anticipated to start in September 2016. The grower food safety course required for supervisors will include an introduction to produce safety, worker health and hygiene training, soil amendments, wildlife, domestic animals and land use, agricultural water, post-harvest handling and sanitation, as well as how to develop a food safety plan.

The training for produce, conducted by the Produce Safety Alliance and/or trained trainers, does not cover training for sprouts; training for sprouts is being developed by the Sprout Safety Alliance and will include topics specifically for sprouts, such as antimicrobial treatment of sprouting seeds.

In the FSVP, the qualified individuals must have the education, training or experience necessary to perform activities as per 21 CFR 1.503. These qualified individuals will develop the FSVP and those activities such as hazard analysis, supplier approval, determining verification activities and frequency, corrective actions and other activities for the FSVP. These personnel must be able to read and understand the records to be reviewed for this program. This means they must know English and may also need to know the local language at point of product manufacture or farming. 

At this time there is no structured training program for these individuals, but the FSPCA training program, alongside education and experience can provide the training necessary for these people to perform the job activities. A PCQI would be qualified for the role of a FSVP qualified individual, but the FSVP probably would not be qualified for the PCQI role. This is because the activities in the FSVP are not as complicated as those required by the cGMP and preventive controls rules, and therefore the FSVP qualifications would not need to be as stringent.

Training Under Proposed Rules

In the proposal for Sanitary Transportation of Human and Animal Foods, 21 CFR 1.910, the FDA requires carriers of these products to train personnel who are engaged in transportation operations. This should include awareness of potential food safety problems that may occur to food during transport, basic sanitary practices that would address those problems and the responsibilities of the carriers in the regulation. As with all training in these regulations, the type of training, who was trained and when they were trained must be documented.

Since this is a proposal, the training for teaching the carrier’s responsibility is not yet finalized but will require nothing more than explaining that section of the regulation. The training of potential food safety issues and the problems that might occur during transport are handled during standard cGMP and food safety training.

For the proposed Intentional Adulteration rule, per 21 CFR 121.160, the personnel and supervisors assigned to the actionable process steps must receive training in food defense awareness and their responsibilities in implementing the migration strategies. Also, as per 21 CFR 121.130, the vulnerability assessment is to be performed by a qualified individual, and this individual is to be qualified through experience and/or appropriate training.

For basic food defense, the FDA offers various courses and information, such as Food Defense 101, on their food defense webpage. An online course is offered in English and Spanish and covers the awareness training and the regulations for employees. Upon course completion, a certificate is provided. The agency also has a downloadable food defense plan builder that can be used to develop a food defense program. The agency also provides vulnerability assessment software, but additional training in PAS 96 or ISO/TS 22000 food defense would aid qualified personnel in making sure that this vulnerability assessment is correct and that the strategies to reduce risks are appropriate and not excessive.

There is an abundance of training courses and materials available from the FDA, USDA FSIS, associations and industry. FSMA employee training requires having personnel with the proscribed education and experience to perform specific tasks, and that they be trained as soon as possible in order for them to develop the programs. Additionally, all personnel should be trained at least annually in food hygiene, food safety and food defense.