Tag Archives: FSMA

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

FSMA and GFSI: Alignment and Gaps

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

A recent FSMA Fridays webinar, presented by SafetyChain and The Acheson Group, focused on the interesting topic of FSMA and GFSI: Alignment and Gaps. The discussion covered questions such as did FDA reinvent the wheel with FSMA, given GFSI? If you are GFSI certified, will you comply with all FSMA rules? What do you need to do in addition? Will FDA accept GFSI certification in lieu of an inspection?

David Acheson, M.D., and Jennifer McEntire, Ph.D., of The Acheson Group gave their perspective on where the rules and guidance shaping food safety programs in the industry are similar, and how they differ. We present below some excerpts.

Did FDA reinvent the wheel with FSMA, with GFSI already there?

Dr. Acheson: At a very fundamental level, GFSI is global and FSMA is more U.S.-centric, focused on protecting the American consumer. If you look back a few years, to the time when FSMA rules were being put together, there wasn’t clear understanding about the impact of GFSI and what it could accomplish. GFSI has evolved substantially since then, both in terms of the various standards, and in terms of the execution (preparing companies for audits and doing the actual audits). While there is a lot of alignment between FSMA proposed rules and the various GFSI guidance documents, I don’t think FDA reinvented the wheel with FSMA, which is more detailed, more prescriptive and U.S.-centric.

Which proposed rules are most similar to the GFSI guidance document, and which are different?

McEntire: If we consider the seven proposed rules under GFSI so far, and compare it with the different ‘scopes’ under GFSI, you can see within one scope several elements of FSMA rule:

Produce rule: In some areas what FDA is looking for is more prescriptive, more stringent than what GFSI has in their books, and in other areas, GFSI standard is more detailed. We need to remember that these are still ‘proposed’ rules, so it is hard to predict where FDA will land eventually.

Preventive controls: There is fairly strong alignment between this rule and GFSI. There is some minor differences, but the approach is quite similar.

Food defense: With this rule, you can see of the greater differences. Under FSMA, there’s a whole new rule, compared to just a few lines under GFSI for food defense. So FDA is more specific in what they are looking for and will expect food companies to do more work, over the GFSI scheme.

Sanitary transportation: FDA said they wanted to align with industry practices, and GFSI Logistics guidance for this rule. So broadly the requirements are consistent.

Foreign Supplier Verification Program: This is an interesting one, because there’s no GFSI call out for international versus domestic supplier. FDA is taking a more specific approach in what needs to be done to evaluate and verify foreign suppliers. In our mind, GFSI is taking a more appropriate approach, which FDA will need to consider, to include all suppliers, global or domestic.

There are other elements of GFSI that FDA has not issued rules such as traceability, but overall there’s general alignment between the two sets of food safety requirements.

When you look at some key differences, again, GFSI is global. FSMA more US focused. GFSI is more guidance documents and broad scope, while FSMA is actual rules.

When it comes to rule-specific differences, if you consider Preventive Controls, the proposed rule looks at it pretty comprehensively, not just at critical points. So while it’s aligned with HACCP principles, it builds on it, and goes beyond HACCP.

Also, there are some terminology differences: FDA calls the point person a ‘qualified individual.’ Each scheme has their own term for this person. Some standards require a team to evaluate – not just one individual.

Will FDA accept a certificate from one of the GFSI schemes instead of an inspection?

Dr. Acheson: This is a million dollar question and often asked. I feel if it is a full course inspection (based on a compliant, an RFR etc.), then no. FDA will want to do the inspection in order to do their regulatory job, as they are supposed to. Remember, there’s a lot of alignment between GFSI and FSMA, though it’s not a 100 percent. So will they accept a certificate in lieu of an inspection? Right now, no. but there will be a point, where FDA will take a certificate as recognition that a company is certified to a GFSI standard – and factor this in to a certain level, for instance, to determine who will get inspected this week versus next month. As the schemes evolve, and as GFSI becomes more aligned with FDA, keeping in mind that GFSI is intended to be more global than U.S. focused, if a company is certified against a GFSI standard, I think it’s likely that FDA will take it seriously.

McEntire: If a company is certified to a GFSI scheme, and is willing to share information of that certification process with FDA, it will go a long way in establishing credibility of the food safety and quality program. Of course, you need to keep in mind that the certificate is limited to that audit, which at best, is a snap shot of the company’s food safety management program a given time. Also, note that GFSI audits are currently announced, versus FDA inspections which are unannounced, where an inspector show s up at your door.

Broadly, if you are certified to a GFSI standard, you are in a good place to comply with FSMA rules, and in better shape than other companies who are not certified. But you need to read the rules, understand the rules, and see what additional things you need to do to be compliant.

Hear more about FSMA and GFSI – Alignment and Gaps, and what you need to do by clicking here.Next FSMA Fridays, on October 31, will cover Foreign Supplier Verification, Produce, Human and Animal Rules – 2nd Review Cycle – Part 2.

Gary Nowacki, CEO, TraceGains, Inc.

How Can You Improve Your Supplier Qualification and Management?

By Food Safety Tech Staff
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Gary Nowacki, CEO, TraceGains, Inc.

Proposed rules under Food Safety Modernization Act are putting new demands on food and beverage companies for prevention-based risk controls. FSMA specifically addresses issues related to this for both foreign and domestic suppliers. This is going to mean either allocating more people and more time or coming up with modern ways to address these increasing and emerging demands.

Gary Nowacki, CEO at TraceGains, Inc. will address the topic of Supplier Qualification and Management at Food Safety Tech’s Food Safety Consortium to be held next month in Chicago. He will speak about how companies are struggling with managing up-stream supplier and ingredient risk and how they can both save time and be more in control of these challenges by using powerful tools and techniques.

Nowacki says that often companies have partial information on necessary documents: “Previously, companies might have felt ok about having at least certain data on their suppliers. That’s not enough under FSMA and the increasing demands of GFSI schemes, audits, and auditors.” By automating tasks that free up valuable human resources to focus on more complex issues, says Nowacki.

Giving an example, he says think about automatically sending out notices to suppliers who are non-compliant on certain information or documents so that a valuable resource doesn’t have to waste time calling or emailing the suppliers.

The role of desk audits

Another way to strengthen supplier relationships is by doing desk audits, the topic that Chris Petrlik-Siegel, Supplier Quality Manager at TIC Gums, will address at the Food Safety Consortium.

In a desk audit, the auditor checks to see if a supplier’s system as documented meets the requirements of the GFSI code under which they are certified. It also confirms if the concerned person has validated and verified the Food Safety Plans and Food Quality Plans. The Desk Audit can be conducted as an off-site or on-site activity and issues found during the Desk Audit will be documented as non-conformities. Depending on the number and type of non-conformities documented, the audit will move to the next phase – the Facility Audit – or not move forward until and critical and major non-conformities identified are properly corrected and corrective action is verified.

“Desk audits are a great way to check how ready you are to be audited. These take a lot less time than an on-site audit, and really help in preparing for the actual audit. Desk audits are more to establish or strengthen the partnership with the supplier rather than to work on an audit for the purpose of complying with regulations,” says Petrlik-Siegel.

She explains that many times, a food company visits a supplier to do an audit, and realizes that it’s a waste of time due to lack of preparedness of the supplier. “Now due to new rules being proposed under FSMA, as an end product supplier, we are responsible for the ingredients in the products, and all the products we are importing from foreign suppliers. So we rely on in-depth audits to ensure that our suppliers have robust systems and procedures in place, in addition to what we follow in-house,” describes Petrlik-Siegel.

So with 70 suppliers, each on an average supplying about 10 ingredients, the Quality Manager stresses on the importance of desk audits preparing you for the final site audits, and also for better compliance with FSMA rules. It’s often overwhelming to do a thorough audit in a matter of one or two days, so it helps to look at documentation and identify any gaps ahead of time, Petrlik-Siegel adds.

Listen to Nowacki and Petrlik-Siegel speak about Supplier Qualification and Management at the Food Safety Consortium. Click here for more information and to register.

Gary Smith, Eurofins’ Food Safety Systems

Why Food Safety Training Fails, and What Can be Done?

By Sangita Viswanathan
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Gary Smith, Eurofins’ Food Safety Systems

The food industry has multiple levels of people involved, ranging from leadership and supervisors, all the way to line and front-end workers. Training, thus, has to not just give directions, but also provide better understanding of why we do what we are supposed to, says Gary Smith at Eurofins.

Smith, who leads the strategic development and oversight of Eurofins’ Food Safety Systems division, including auditing, certification, and training programs, says that “training for supervisors and leadership usually works well. But training workers is fraught with challenges. General training is focused more on giving directions, but not so much on providing understanding. People often skirt this rationale with the line workers, or it’s lost in translation, or missed out due to time constraints, turnover, vacation days etc. That’s where training fails.”

What would happen if we don’t spend this time address the ‘why’ behind training? People then get busy, and then miss out on steps and processes, and that causes problems, Smith replies. “It’s also critical to aim to strike a balance, for instance with line workers training – you have to ensure they understand the importance of what you are training them on, but at the same time, you cannot go too deep into the training, that would be either unnecessary or redundant.”

So what kind of training will continue to be the focus for the industry? The usual ones will continue to be important, according to Smith: Regulatory requirements for seafood, specific HACCP requirements for meat, HACCP training for employees directly responsible for food safety and quality, standards training; training for audits… For line workers, training also needs to cover specifics of their jobs, employee hygiene practices (for instance, why it’s important to wear gloves, hairnets etc.), and how to handle customer complaints.

Proposed rules under the Food Safety Modernization Act are having a positive impact on training needs, says Smith. “Everyone is now waiting for the final set of rules to be announced and implemented. A lot of good things are coming out of it, such focus on risk management and process control, understanding which products are high risk and low risk. FSMA has brought back HACCP for those industries that haven’t really had strict regulatory requirements for food safety – such as seafood, fresh produce, juice etc., or ready-to-eat products that may have escaped regulatory scrutiny in the past, such as fresh produce, and bakery products. Now the industry as a whole needs to focus on FSMA implementation, by companies helping its employees understand where the food safety risks are, how to manage them, document them, and mitigate them.

How can training help companies towards certification? When training leaders that are going to be implementing the food safety standards within their facility, it’s important to be comprehensive about understanding the specific standard. There is also the opportunity to focus on common non-conformances and say ‘this is where others have struggled and this is what you can do to avoid those non-conformances.’ Training can provide lessons, solutions and ideas to address common problems to addresses non-conformances before an audit. It can help drive continuous improvement, and help secure management commitment.

What are some of the common training themes that have resonated with Smith? He says that mostly employees bring up the issue of getting management to understand the need to focus on food safety training and procedures. “People who have attended my classes are usually struggling with getting management commitment. They are often told they need to be certified to a particular standard by end of the year, and so figure it out, but there’s no skin in the game from management. I help these trainees walk through the various steps that they can take to secure that commitment, how to talking their language in terms of more efficient production, and higher dollar savings etc.,” Smith describes.

Some challenges that he has observed in his years of training? Smith says that often times the trainers are great auditors, but poor trainers. “They will quote standards, and regulations. They are too black and white, and objective. However, training can have successful outcomes only when it’s practical and linked to real situations and ideas.”

John Kukoly of BRC Global Standards

Where BRC is Going, and How Can You Get There?

By Sangita Viswanathan
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John Kukoly of BRC Global Standards

Food Safety Tech (FST): We’re very excited to have you participate in the SafetyChain/ FoodSafetyTech’s GFSI Leadership Webcast Series with the October 24 BRC – The Road Ahead webcast. We know that you’ll first be addressing what is new with BRC today. What are some of the things you’ll be talking about in terms of current changes?

Kukoly: We are just on the cusp of releasing Issue 7 for BRC. This is scheduled to be released in January 2015. With this, there will be some changes made to how food companies and facilities can obtain the BRC standard. We have a really unique system, termed BRC Participate, that we propose to unveil during this time, which I will talk about more during the webinar.

FST: We know that audits will be a topic of many questions. Is BRC planning changes to the way it does audits? What are some of audit-related topics you’ll be addressing in the webinar?

Kukoly: One of the changes I will be talking about is the auditor-competency program. Other topics will include expansion of our unannounced audit program. BRC is currently the leader in this area, and Wal-Mart has specifically asked us about this. We have done such audits in over 600 sites already, and are currently the go-to people for unannounced audits now. We are also forming BRC Global Markets, which will help small and less developed companies to get ready for certification.

FST: You will also be talking about the direction of BRC in 2015 and beyond? Is there a “theme” or specific set of business drivers that are driving future changes to BRC?

Kukoly: In my opinion, the two most critical areas of focus for the food industry right now are risk management and supplier management. These are the two main key elements being covered in all new regulations under development, and if a food facility has these covered, then they are in a good place. These are the two specific drivers that are shaping future changes to the BRC standard.

FST: While we all know that while change is important, it’s not always easy to get already-burdened food safety organizations to embrace change. What are some of the things we’ll learn in the webinar about why embracing change is critical to the ongoing success of BRC certification?

Kukoly: I don’t think ‘why’ should be the right question. We should focus on ‘HOW’ to go about this. And I think we need to talk about food safety culture and change management. These are the areas that are key to success and embracing change.

FST: We know that you’ll be providing advice on how companies can start today to prepare for tomorrow’s BRC. Can you tell us some of the topics you’ll be addressing in this part of the webinar?

Kukoly: One of the topics I will be addressing is training, not necessarily for BRC, but for obtaining the right skill sets such as risk assessment or HACCP. These are necessary for any food manufacturing organization to prepare for tomorrow’s BRC, and to have robust systems and processes in place.

FST: It has been said that GFSI certification is a very good start to preparing for FSMA compliance. What are some of the key points you’ll be addressing when it comes to FSMA compliance and alignment with BRC?

Kukoly: If you look at FSMA expectations, they are very well aligned with requirements of BRC standards, whether it be supplier management and verification requirements, or risk assessment etc. Beyond that, it is about strength of traceability procedures, knowledge of FSMA within the facility and its qualified individual. The focus is primarily on robust supplier management programs and implementation. If all these are in place, then you are in a very good starting place for FSMA compliance.

Listen to John Kukoly talk more on these topics and take your questions live in the BRC – The Road Ahead webinar on Friday, October 24, 2014 at 10:00 PT/ 1:00 ET. Click here to register. 

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

FSMA 2nd Review Cycles: A Q&A on Preventive Controls

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

On Friday September 19, 2014, FDA finally released re-proposals to four of the main FSMA-related rules: Preventive Controls for both Human and Animal Food, the Produce Safety Rule, and the Foreign Supplier Verification Program. The 75-day comment period will close around mid-December, after the proposals are officially published in the Federal Register.

At a recent FSMA Fridays webinar, presented by SafetyChain, Dr. David Acheson and Jennifer McEntire, Ph.D., of The Acheson Group focused on changes proposed to the Preventive Controls rule (for Human and Animal Foods). We present below some excerpts:

Q: What is the further definition of situations where environmental testing will be required?

Dr. Acheson: This is one of three very predictable components of the reproposals coming out. We have been saying for a long time to expect environmental monitoring to come back into the regulations. We all wish we have environmental monitoring everywhere, but this is not practical, feasible or environmentally focused. So what FDA has done now is to say we expect you to look at your environment, especially if it’s ready-to-eat products, and require you to conduct environmental monitoring in those specific areas. The change proposed is not fully prescriptive, and facilities need to conduct environmental monitoring as appropriate to their food products, the facility etc. It is required it specific circumstances where ready-to-eat product is exposed post-processing, and before packaging. Under this reproposed rule, the agency requires you to have strong environmental monitoring procedures as needed, records of these methods, and proof that you have corrective actions built in, when needed.

Q: What is the role of finished product testing in verification of food safety plans?

McEntire: When FSMA rules were initially announced, there was a lot of uncertainty whether FDA would require finished product testing, as in many cases, this would be like looking for a needle in a haystack. Now FDA is asking you to do finished product testing as necessary, as a verification activity to check if your overall food safety system is working well. Companies will need to look at the types of preventive controls that in place, at areas such as sanitation, employee hygiene (hand washing) etc., aspects that FDA does not require to be validated, and use finished product testing as a way to make sure that these are being done the way they are supposed to be. If you think it’s appropriate and if you choose to have finished product testing as part of your verification, make sure to have written procedures, documentation, corrective actions etc.

Q: What are the requirements and responsibilities for controlling suppliers along a company’s supply chain?

Dr. Acheson: Everybody recognizes that controls supply chain risk is an important part of controlling brand risk, AND it is a huge challenge. So it makes logical sense, and we know from experience, that suppliers have and will continue to send out food and ingredients that are not suitable, cause problems and cause recalls. Another reason is based in the Foreign Supplier Verification Program, which is essentially a different take on Supply Chain control. The only difference is that FSVP is a risk control requirement for imported, FDA-controlled foods. It looks at who you are getting food from, is there a hazard in it, and how is that hazard controlled? With the FSVP, we had set a different bar for imported foods than for foods sourced domestically. So this new addition rule tries to align Preventive Controls rule with the FSVP, by adopting a similar approach. So now it doesn’t matter if you source domestically, or from outside, you need to have a strong supplier controls program, and this has to be risk-based.

So look at your ingredients or materials. Do they contain a significant risk? If so, who’s controlling that risk – you or the supplier? For instance, if you are sourcing an ingredient like an herb, which has been associated with a Salmonella outbreak, then yes, there is a risk associated with it. So this ingredient that you are sourcing from different places is a significant hazard, but what you are doing with it is putting it in a blend and then cooking it in a product. So you are controlling that risk, and you don’t need to document that from the suppliers. However, the same ingredient, if you are just using it as a garnish, without a kill step, the control falls back on the supplier. And you as the user, have to make sure that the supplier is controlling that risk. The agency is giving some options, such as audits, testing, verification of supplier programs etc. to manage this requirement. For instance, if your analysis says there’s a significant risk, and it can lead to a significant adverse effect or death, Class 1 type situation, if that ingredient poses that level of risk and you are not controlling it, then an annual audit will have to be conducted of that supplier.

Where does GFSI fit into this? In my view, GFSI will align with this. So if you have a GFSI audit of the supplier, then you are going to be in pretty good shape.

Thomas R. Weschler, Founder and President, Strategic Consulting, Inc (SCI)

High False Positive Rates for Pathogen Food Safety Testing

By Thomas R. Weschler
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Thomas R. Weschler, Founder and President, Strategic Consulting, Inc (SCI)

This article looks at proficiency testing (PT) for pathogen analysis, and the recent finding by the the American Proficiency Institute (API) of a 6.6 percent false-negative rate on food safety PT samples (14-year average for the 1999-2012 period).

While at IAFP this year, I met with Heather Jordan, who directs food PT programs at API. The proficiency testing programs are used at many food labs in conjunction with lab accreditation programs. Proficiency testing is done at food plant labs (FPLs) and corporate labs, as well as at food contract testing labs (FCLs) as a way to demonstrate quality results in their food micro and chemistry testing.

More proficiency testing but less proficiency?

In fact, the use of PTs is increasing in food labs, which is probably tied in part to the push for lab accreditation by FSMA and non-government groups like GFSI. Yet it seems to me that the current use of PTs doesn’t go far enough to enable an FPL or FCL to demonstrate overall laboratory competency, and gain or maintain accreditation (ISO 17025).

In most labs, PTs are done just a few times a year. And really, they test the competency of the lab technician and protocols used in analyzing the PT samples. They are not a holistic measure of the lab and its ability to consistently generate quality results on every test run by every operator in the lab.

In a previous life I ran a group of environmental testing labs, which also are required to run PT samples during the year. From this experience, I know that lab personnel are aware that PTs are in-house: The sample-receiving group logs them in, and then alerts management. As a result, the best operators usually are assigned to run the PTs. This kid-glove treatment is not representative of day-to-day practices and processes. If we really want to validate and accredit the proficiency of an entire lab, shouldn’t every operator be tested on all protocols in use?

Plus, if labs know when they are running PT samples, and likely have their best operators running them, shouldn’t there be few, if any, false-negative or false-positive results? Surprisingly, that’s not what the API research found…

API study: Performance accuracy for food pathogens remains problematic

In a retrospective study, “Pathogen Detection in Food Microbiology Laboratories: An Analysis of Proficiency Test Performance,” API analyzed the results from 39,500 food proficiency tests conducted between 1999 and 2012 to see how U.S. labs are doing in detecting or ruling out contamination of four common food pathogens.

Over the 14-year period, “False negative results ranged from 3.3 percent to 14.0 percent for E. coli O157:H7; 1.9 percent to 10.6 percent for Salmonella spp; 3.4 percent to 11.0 percent for L. monocytogenes; and 0 percent to 19.8 percent for Campylobacter spp.” Most concerning is that while both false positive and false negative rates were down in the last year of the study, the cumulative false negative rate for the 14-year period was 6.6 percent.

As we know, false positive results (in which a sample that does not contain pathogens is incorrectly shown as positive) are a nuisance. But false negative test results—which fail to detect true pathogenic organisms in the sample—are not unacceptable.

Tom-Weschler-False-Negatives-Sep-2014

The cumulative average false positive rate was 3.1 percent, less than half of the false negative rate for the same period.

The objective of the study—and, I would think, of proficiency testing in general—is to demonstrate improvement in lab performance year over year. The results of the API report concluded to the contrary, however: “Performance accuracy for food pathogens remains problematic with the recent cumulative trend showing a slight decrease for false positive and false negative results.”

Clearly if false negatives happen in proficiency programs, they happen in the course of regular testing at food labs. I’m told that many FCLs and FPLs rely on other parts of their QA systems to make sure testing is being conducted properly. Even so, the documentation of ongoing and unacceptably high false negative rates in PT testing is a big concern for everyone. It also points to a number of follow-on questions:

  • Would the false negative and false positive results be even higher if every technician, rather than the best operator, performed the analysis?
  • PT samples are created in only a couple of sample matrices. Would results be even worse if performed on the myriad of sample matrices present in the food industry?
  • What are the performance results among all of the pathogen methods available? Are some methods better than others when measured in real world conditions? Do the more complex protocols of some pathogen diagnostic systems result in poorer PT performance results?
  • Would PT results and, even more important, lab proficiency improve if the frequency of PTs increased, and were required of every technician involved with real food samples?
  • How can proficiency testing be used to isolate problem areas, whether in the pathogen diagnostic method or the competency of lab operators and processes?
  • And finally, is the performance data different between food contract labs and food plant labs? And are all FCLs are equal, or are some more able to deliver quality results?
Dr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology Laboratories

Environmental Monitoring – Another Leg on the Food Safety Management Stool

By Sangita Viswanathan
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Dr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology Laboratories

Eurofins laboratories routinely test for the presence of the infectious bacterial generaSalmonella and Listeria monocytogenes in the food processing environment. While L. monocytogenes long has been known as an environmental contaminant, only recently Salmonella has been considered a persistent environmental contaminant.

At this year’s Food Safety Consortium (November 17-18, 2014, Schaumburg, IL), Dr. Douglas L. Marshall, Chief Scientific Officer – Microbiology, for Eurofins Scientific Inc. will present a workshop on Environmental Monitoring. This workshop will provide an overview of analytical methods used, a discussion of the zone approach to environmental monitoring, and a practical example of the use of microbial genetics in Eurofins’ Source Tracking Program to identify and eliminate a pathogen harborage.

In this Q&A with Dr. Marshall, we present a sneak-peek into what to expect in this workshop. Register today to learn more.

Food Safety Tech (FST): How are environmental monitoring requirements changing under FSMA?

Dr. Marshall: The Food Safety Modernization Act passed by Congress contains language in SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS stating: ‘‘(4) the preventive controls implemented under subsection (c) are effectively and significantly minimizing or preventing the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means” and ‘‘(C) An environmental monitoring program to verify the effectiveness of pathogen controls in processes where a food is exposed to a potential contaminant in the environment.”

The Preventive Controls for Human Food Proposed Rule has moved environmental testing to the appendix. It is clearly FDA’s intention that firms use environmental monitoring but how this will ultimately play out in the final rule is unknown. The companies we work with are finding a substantial non-regulatory push for environmental monitoring from their customers. As a result, firms without environmental monitoring programs will find it challenging to escape criticism from inspectors, auditors, and customers.

FST: What are some broad topics you are going to be covering in your FSC presentation?

Dr. Marshall: This EMP workshop will deliver tips for an effective pathogen monitoring program. Highlights include information relevant to answering many EMP questions such as what to test for, what is the value of indicators; where to test, what methods to use, what test volumes are appropriate, how to use trending, and how to remediate an environmental problem.

FST: What are some key challenges when companies do environmental monitoring? For Salmonella, and for Listeria?

Dr. Marshall: Many companies find it difficult to start an EMP program and fail to use the program in a proactive manner as an assessment tool. Environmental monitoring is an essential tool for microbial control, but it is not a control program. Robust programs target areas in a processing plant where environmental pathogen control is critical to product safety. The pathogen of concern may differ depending on food product type and processing conditions.

FST: Why is it important for food companies to pay attention to this critical area of testing?

Dr. Marshall: Numerous recent high-profile foodborne disease outbreaks and large recalls have been traced to poor environmental controls. Lack of effective environmental monitoring by producing firms contributed to these events. As a result, inspectors, auditors, and customers are demanding the placement of environmental monitoring programs as an additional leg on the food safety control stool, adding to GMPs, SSOPs, and HACCP.

FST: What kind of technologies will you be talking about in your presentation?

Dr. Marshall: The talk will present an overview of analytical tools required for routine monitoring and give an example of the use of genetic strain typing as a source-tracking tool for remediation.

Learn more, and register today for the Food Safety Consortium – Multiple Conferences, One Event, featuring 30 plus expert industry speakers, and speakers from FDA, CDC and USDA. 

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

SQF: Where is it Going and What Does it Mean to You

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

In a recent webinar, Robert Garfield, Senior Vice President of the Safe Quality Food Institute talked about the SQF standard, changes made in 2014, what is expected in 2015, and how companies can use SQF to be better prepared to comply with rules proposed under the Food Safety Modernization Act. We present below some excerpts from the webinar, organized under the 2014 GFSI Leadership Series. The next webinar in the series will focus on FSSC 22000. Click here to register.

Where is SQF going in 2015 and beyond?

Garfield: The standard is going to be focused on enhanced compliance programs and improving the database reporting systems. For instance, if it concerns someone in the bakery or dairy industry, we would like to know how they are doing versus the industry as a whole. We are hoping that better database reporting can help with this, especially when it comes to non-compliances.

Another area we are working on is establishing Cooperative Agreements. In 2014, we finalized an agreement with the American Feed Industry Association and we are working with their food safety program. We are hoping to not just work cooperatively with the private sector, but also with various government agencies and other stakeholders.

Other areas we are growing in 2015 are expanding our language alternatives, subject matter training and developing industry specific guidance.

There are many changes proposed to food safety regulations and food safety schemes such as SQF. How will companies be affected by these changes and why is embracing these changes so important to industry?

Garfield: Embracing all these changes is critical for the food industry to do everything they possibly can to ensure that they are making and selling a safe product. At the end of the day, there is no one ‘magic bullet’ solution to food safety. Embracing these changes to food safety rules and standards will help the CEO and management team sleep better at night, knowing that they are doing what they can to protect their product, their brand name and their consumers. Also, companies need to understand that the regulatory climate will completely change in the next few years, so it’s critical for companies to start acting now to meet these new requirements that will start being in effect from October 2015.

How can companies start preparing today for tomorrow’s SQF?

Garfield: I tell companies and retailers I talk to that if they are interested in doing SQF because they want to be ‘GFSI certified,’ that’s the wrong reason to do this. To get started, management commitment and changing the culture of the entire company is critical. Starting from the CEO and going all the way to the man operating machinery on the floor, you should aim to get a commitment to food safety, where food safety management is the most important issue for the company. If you start working on that today, you can accomplish great things for the company in not just reducing recalls, but improving the overall functioning of that company.

How can SQF help prepare companies for FSMA?

Garfield: The first step is to look at the Preventive Controls and the Fresh Produce rules and see how these apply to your company. I suggest hiring an independent expert to take a look at your facility and see how your company fares against these rules and have a better understanding about where you will be when these rules are finalized by October 2015. While you will have one to three years to comply with these rules after that point, you need to get the management buy in and strong food safety management systems in place now. Start now, and don’t wait for the final rules to be announced.

Listen to this complimentary webinar today to learn more about how SQF differs from other food safety programs, unannounced audits, changes with allergen control standards, and how to become SQF certified. Click here to access the recording.

2014 GFSI Leadership Series continues with FSSC 22000: The Road Ahead. Click here to register for this informative webinar on Friday, September 26, 2014, featuring Jacqueline Southee, U.S. Liaison, FSSC 22000, who will talk about what’s new for FSSC 22000 this year, where FSSC 22000 is going in 2015 and beyond, how you will be affected by the changes, and how to start preparing today. Plus Jacqueline will take your questions live!

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

FSMA Fridays: Concerns Around High-Risk Food Methodology

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

In February 2014, FDA published a Draft Approach for Designating High-Risk Foods under the Food Safety Modernization Act, with the purpose to identify high-risk foods based on specific parameters for additional recordkeeping requirements to enable rapid, effective tracking in the event of foodborne illness outbreak.

What are the factors by which a food is designated as ‘high-risk?” will FDA do such an analysis for every single food product? And what are concerns about this approach?

At a recent FSMA Fridays webinar, presented by SafetyChain, Dr. David Acheson and Jennifer McEntire, Ph.D., of The Acheson Group focused on this topic.

What will the high-risk foods list be used for?

Dr. David Acheson: What FDA wants to do with the high-risk foods list is to mainly leverage this for better product tracking. FDA will also have greater authority to ask for more information and keep more records for these high-risk foods, though the agency hasn’t clearly specified what information yet. Also the frequency of routine inspections for high-risk foods will be greater: once every three years, compared to once in every five years for non-high risk foods. One area which FDA hasn’t elaborated on is importers needing certificates for high-risk foods entering the U.S. Initially, the agency had considered this, but didn’t have a system in place to require this. Now the requirements are proposed in the FSMA rules and third-party audits can support this.

What are factors that will determine if a food is high risk?

Jennifer McIntyre: FDA considered several areas and has finalized a detailed methodology to identify high-risk foods based on the following parameters:

  • Frequency of outbreak and occurrence of illness associated with that food since 1998;
  • Severity of those illnesses;
  • Likelihood of contamination;
  • Growth potential of that food;
  • Is there an opportunity during processing for that product to become contaminated;
  • Consumption of that food product; and
  • Economic impact associated with that food product in case there’s an outbreak or recall.

This approach is based on an evaluation of chemical and microbial hazards combined with foods using criteria that encompass the FSMA-required factors.

How will each food be scored and is there a distinguishing line between high-risk and non-high risk foods?

McEntire: Food will be rated on a 1 to 9 scale, with 1 being low, 3 being medium, and 9 being high. Companies have these three options to choose from. There’s no clear line the agency has proposed to determine what foods are on the list and what aren’t.

Is FDA going to do this analysis for every single food product? Where will they get the data from?

Acheson: There’s no way the agency can do this for every single food product. They are looking at a lot of parameters to consider. What they might do, and they are already doing, is try to bunch food products and commodities together, so there will be buckets of food identified as high-risk and non high-risk. Getting all that data will prove to be a challenge, considering that what’s available is quite thin. Private sector may have data that could help the agency, but then there’s the concern that if you share the data voluntarily, you have a risk of your product being classified as high-risk.

Are there any concerns being expressed in the industry about this approach?

McEntire: There are many concerns that industry is expressing right now, such as, given the limited data, how do you choose which foods to look at? How do you make sure that the analysis of one food can be applied to another food? How can we factor differences in processing and facilities? How will all the data be used? The parameters specify considering outbreaks going back to 1998 – some of this information has changed tremendously, and this will not factor in new regulations under FSMA.

One major concern is how can I get off the list? If you are considered a high-risk food now, but change your methodologies etc., can you get off the list? We need to see another iteration of this proposed rule from FDA to see if this rule can evolve and address some of these concerns.

What are some next steps for high-risk food methodology and what should industry do to prepare?

Acheson: Determining whether a food is high-risk or low risk will depend on the type of data being collected. The agency’s authority to increase demand for data for purposes of better tracking will require more robust data collection on the part of industry. Food companies will need to assess the data sets they are collecting now, and their product tracking system. Consider the IFT report and its recommendations to learn specifically what data should be collected. If a company determines that some of its products are going to be designated as high-risk, then they need to consider what the criteria will be for gaining that import certificate. Is that food being produced according to the standards that FDA is expecting? Pay attention to your foreign suppliers and ensure that they understand the need to be compliant with FSMA rules, and have sound food safety programs in place.

If this rule is a one-way street, where a food can only be moved from low-risk to being designated as ‘high-risk,’ then that would be disappointing and would detract from seeking improvement and rewarding behavior. The rule needs to consider situations when a company puts in specific mitigation steps in place, so can the food then be categorized as low risk?

For more details and to access FSMA Fridays webinars, please click here.

Robert Garfield, Senior Vice President of the Safe Quality Food Institute

SQF – The Road Ahead: Interview with Robert Garfield

By Michael Biros
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Robert Garfield, Senior Vice President of the Safe Quality Food Institute

Food Safety Tech: We’re very excited to have you kick off the SafetyChain/Food Safety Tech GFSI Leadership Webcast Series with your August 22 webinar, “SQF – The Road Ahead” webinar. Can you start by telling us what is new with SQF today? What are some of the things you’ll be talking about in terms of current changes?

Bob Garfield: We’re very busy here. We have a new version of our code, 7.2, which was introduced in the beginning of July. GFSI benchmarks standards every 3 years. Historically, SQF hasn’t waited for every 3 years to revise our code. This is the second time since our last benchmark that we will be revising our code based on the best science and technology that our stakeholders are putting forward. We’re pretty excited about that. We’ve added in some things that we think are important for all suppliers and people using the SQF code to keep them at the leading edge of science, technology, and the needs of buyers. That’s the primary one, but there are a bunch of things that I will be talking about as well in the webcast, including new modules on produce, feed, and pet food.

FST: We’re sure that unannounced SQF audits will be a topic of many questions during the webcast. What are some of the key takeaways attendees will leave the webinar with on this topic?

Garfield: Change is always difficult for some organizations. I understand why, but going through the SQF process is not to just get a certificate on the wall. We know from our stakeholders that it’s a commitment to food safety management, all the time, from the top to the bottom of a facility’s management. A facility needs to be audit-ready all the time, and we believe that the unannounced audit protocol that we are establishing will allow facilities to accomplish that audit readiness goal. We are fully aware that regulators and other food safety stakeholders are more and more looking at unannounced audits as the direction that food auditing needs to take in order to ensure consumers that what we are doing is the best it can be. It’s the most that we can do to ensure the safety of the food supply.

SQFI LogoFST: You will also be talking about the direction of SQF in 2015 and beyond? Is there a “theme” or specific set of business drivers that are driving future changes to SQF?

Garfield: Yes, there is. The business driver that is the primary focus of SQF is exactly what our executive committee from the Food Marketing Institute has told us – that the value proposition for SQF is to improve safety internationally as much as possible. Retailers are the closest that anyone can get to consumers. They believe that the purpose and the scope of SQF has to be continuous improvement to make food safety as close to foolproof as possible.

FST: What are some of the things we’ll learn in the webinar about why embracing change is critical to the ongoing success of SQF?

Garfield: Change is always critical and important. Embracing change is critical to the success of SQF because it is not a stagnant standard. It changes as science and technology evolve. Food safety and food safety management in particular are two areas that are constantly evolving as we learn more about how to protect the food supply chain, and we continuously update the code to make improvements that reflect this. Change is critical to the success of SQF. We are constantly evolving the code – it’s a process that must be ongoing.

FST: We know that you’ll be providing advice on how companies can start today to prepare for tomorrow’s SQF. Can you tell us some of the topics you’ll be addressing in this part of the webinar?

Garfield: To clarify, SQF doesn’t provide advice – we provide guidance with the SQF code. As we continue to evolve the code, we also evolve our guidance to support that process. I’ll be talking about things we do to help our users and stakeholders to evolve their own knowledge. For example, I’ll discuss our advanced practitioner course that we’ve just started to offer to help practitioners gain better understanding and know-how about how to manage food safety at their facilities.

FST: It has been said that SQF certification is a very good start to preparing for FSMA compliance. What are some of the key points you’ll be addressing when it comes to FSMA compliance?

Garfield: It is a good start. SQF is an international code and there are things in the code that are equal to or above what FSMA is requiring. There are also areas that are different. This is why we’ve hired Dr. David Acheson to do a comparison of our code against FSMA’s proposed preventive control and produce rules. Both of these comparisons are available on our website at www.sqfi.com. We’ll be able to make more comparisons/gap analysis when the final rules come out in 2015. As I discussed with FDA, we’ll look at the final rules and see how we match, exceed, or may need to do some work on our particular code if we think it’s appropriate.

Register for this complimentary webinar by clicking here.