Tag Archives: FSMA

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

Environmental Monitoring – Another Leg on the Food Safety Management Stool

By Sangita Viswanathan
No Comments
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
No Comments
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
No Comments
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
No Comments
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.

Safe Food Coalition Calls on OMB and USDA to Release Revised Poultry Rule for Public Comment

By Food Safety Tech Staff
No Comments

The Safe Food Coalition wants the public to be given an opportunity to comment on the changes made to the proposal before the rule is finalized.

Members of the Safe Food Coalition called on the Office of Management and Budget and the U.S. Department of Agriculture to release a revised version of USDA’s proposed rule to modify its poultry slaughter inspection program, open the rule up for a comment period of 120 days, and hold public meetings on the revised rule.

Last week, USDA announced it was sending a revised version of its proposed poultry rule to the Office of Management and Budget for review. In doing so, USDA officials said that the rule had been significantly changed based on stakeholder feedback.

However, in a letter to USDA Secretary Tom Vilsack and OIRA Administrator Howard Shelanski, members of the Safe Food Coalition noted that “stakeholders have no information about what those changes entail. We have raised numerous concerns about the negative impact USDA’s proposal will have on food safety and consumer protection. Many other public interest groups, members of Congress and even other government agencies have raised concerns as well. Considering the importance of this rule, the public should be given an opportunity to comment on the changes made to the proposal before the rule is finalized.”

The groups noted that the Food and Drug Administration is carrying out just such an action: “FDA published a proposed rule in 2013 implementing the produce safety provision of the Food Safety Modernization Act. Following the close of the comment period and in response to widespread stakeholder concerns, FDA announced that it would revise its proposal and re-publish it for public comment. FDA’s approach would ensure that the public has an opportunity to comment on substantial changes to its proposed rule before it goes into effect.”

Members of the Safe Food Coalition have repeatedly expressed serious food safety concerns with USDA’s proposed rule. 

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

Pet Food Safety: Regulations and Challenges

By Sangita Viswanathan
No Comments
Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

Alan Baumfalk is Pet Food Safety Specialist and food safety Auditor at Eurofins US Foods Division. After more than three decades of experience in human food production facilities, Baumfalk began inspecting and auditing pet food companies with a fresh pair of eyes and in his opinion, “pet food plants typically are very well maintained, embrace technology, are highly automated, have great productivity and are very efficient with their sanitation and production.”

In an interview with Food Safety Tech, Baumfalk talks about differences in production of human food and pet food; lessons learned from historical incidents such as melamine in pet food and contaminated chicken jerky; what are some gaps in pet food safety he’s noticing and impact of the Food Safety Modernization Act or FSMA on this sector.

Food Safety Tech (FST): What are the differences between the production of human food and pet food?
Baumfalk: In most cases, pet food facilities are dry facilities, making kibbles and similar products, and their cleaning sanitation processes are mostly sweeping and dusting, with very little water involved. When it comes to regulations covering pet food facilities, most of these fall under FDA jurisdiction, and pet food facilities need to have in place risk-based HACCP plans to ensure food safety. Some of the challenges involved in pet foods are how do you do sensory testing on dry pet food or test for taste or consistency? Pet food testers look at certain quality attributes such as color, look, smell and taste of the product. They look for data such as amount of protein in the food etc. They also need to consider if humans – especially the elderly, or children – would consume the pet food product, because this can have many food safety implications.

FST: Humans have allergic reactions to certain food ingredients. Do pets have similar concerns of allergens?
Baumfalk: We don’t know if pets suffer allergic reactions to any specific food ingredients similar to humans. Pet food manufacturers are not subject to allergens and are exempt under FDA’s allergen management regulations. However, there are strict GMPs maintained in pet food production facilities, so that known allergens are identified. Pet food manufacturers give attention to allergens though they are exempt because it’s possible that the allergens could get transferred to a human in the house who could be allergic to nuts or soy, and this could be a huge problem. In our experience, we have seen that pet food can be occasionally consumed by a child or an elderly pet owner, out of curiosity.

FST: How about pathogens such as Salmonella and E.coli, are pets susceptible to these?
Baumfalk: Pets are not typically affected by pathogens such as Salmonella or E.coli, and this goes back to their genetic background, which is, dogs coming from wolves, and cats from tigers and lions. These animals are used to eating things with pathogens, fecal matter etc. However, humans are at risk of infection by Salmonella and E.coli, so while the end consumer of pet foods are not affected by these pathogens, their handlers are. Hence, pet foods are tested for Salmonella and E.coli to make sure they are pathogen free. They have Critical Control Points (CCPs) and kill-steps just like human foods, and pet foods are diligently sampled before they are released in the market. Environmental monitoring is also strictly carried out – such as extensive swabbing of processing floor, walls etc. to test for Salmonella/ E.coli/ mycotoxins etc. If a raw material exceeds FDA guidance for mycotoxins, then they are rejected. Many manufacturers test for mycotoxin levels in finished product as well.

FST: Are there differences in auditing pet food companies versus human food manufacturers?
Baumfalk: All pet food companies are looking to get certified and audited under a GFSI-recognized scheme. SQF is probably the biggest standard though some choose BRC. Eurofins has close ties with the American Feed industry Association (AFIA) which recommends SQF, and so we follow the same standard when auditing pet food facilities. SQF has modules specific to pet food category and dry pet food products. There are a lot of similarities with requirements for human food – for instance, pest control within a pet food plant is the same as within a human plant. The commitment and requirement for compliance is the same.

FST: What are some gaps or challenges in pet food safety?
Baumfalk: Most of the folks working in the pet food industry have a background in human food and are very much aware of the technical and regulatory requirements for making human food, so they end up carrying it over to pet food production. They typically follow GMPs and HACCP, and safety plans to ensure there are no food safety gaps. While most pet food companies meet, or even exceed, compliance requirements, there are always some people in the industry that don’t get the message.

FST: When we think about pet food safety, the history of melamine contamination of pet food, and tainted chicken jerky from China come to mind. What are lessons learned and how can the pet food industry be prepared for the unknown?
Baumfalk: The melamine adulteration and chicken jerky contamination incidents have taught the industry to be on guard. The industry has to make sure that they are in close alignment with their industry association which speaks for them, read technical documents, hire and train knowledgeable staff – all of which helps constantly look for the next thing that we weren’t aware of. Apart from diligently monitoring the global supply chain, it would help to have strict audit specifications for global suppliers. If something is coming from the other part of the world, where there’s a history of food safety standards not always being up to par, the pet food industry needs to make sure to buy only from a known and approved entity. Also look for lessons that can be learned from the human foods industry. Read about recalls and withdrawals and find out why that happened, if the pet food industry has similar exposure, and how this can be addressed.

FST: What will be the impact of the proposed pet food safety rule under FSMA be on this industry?
Baumfalk: FSMA is going to tighten things up, paying a lot of attention to the global supply chain and any vulnerabilities. While regulations are still being finalized, the pet food industry is already aligning itself with these proposed regulations. The technical and regulatory folks in the industry are following it; they are reading food safety journals and interacting with their associations for guidance and for making comments on the regulations. We are also updating our auditing checklists to see how we can align better with new FSMA requirements.

For more information on Eurofins, it’s pet food and auditing capabilities, click here.

Dr. Jim Fredericks, Chief Entomologist & Vice President of Technical and Regulatory Affairs, National Pest Management Association
Bug Bytes

Why is Pest Management Critical to Food Manufacturing Operations

By Dr. Jim Fredericks
No Comments
Dr. Jim Fredericks, Chief Entomologist & Vice President of Technical and Regulatory Affairs, National Pest Management Association

Every manager of a food manufacturing plant knows that food safety cannot be compromised under any circumstances and that the entire process is dependent on a number of aspects working effectively, efficiently and in a healthy and safe manner. However, no process is foolproof and any breakdown in the manufacturing process could lead to contamination. Some of the most pervasive contaminants come as a result of insects, rodents and other pathogens finding their way into the plant. It is for this reason that pest management is critical to food manufacturing.

Depending on the type of food product and how it is processed, there are ample opportunities for pests to associate themselves into the food manufacturing life cycle – be it during the growth cycle, at harvest, within the mode of transportation, during material preparation and final processing.

Fortunately, today’s scientific equipment provides the ability to detect amounts of contaminated materials in a given finished product down to the nanogram and “zero” continues to get smaller and smaller with each advancement in chemical [contaminate] detection technology. However, as plant science and seed chemistry improve, so does yield production. With this production increase comes additional processes that create opportunity for pest threats to enter food-manufacturing operations. In order to maintain a safe and clean facility both the food manufacturing facility manager and pest management personnel must address each issue head on.

There are a number of factors that pose challenges to proper pest management in food facilities such as the time of operation [some pests prefer daytime, while others prefer nighttime], production cycles [season of harvest can denote degree of pest infestation], maintenance schedule [how often do lines or plants shut down for cleaning and up keep], delivery schedule and flow of raw materials [when and how they enter and leave] throughout the plant. The addition of other factors, like moisture levels and temperature extremes within the construction elements of the plant, can create ideal conditions for pest harborage and nesting areas.

The world is a smaller place today and food transportation can be accomplished by multiple sources; food products are now shared across borders and oceans in a much shorter time frame than before. Due to the potential introduction of a new pest species or plant disease, it is crucial that facilities and their pest management partners develop a common platform for risk assessment, analysis and preventive controls to achieve success. Having the ability, discipline and quality control processes in place to intercept or disrupt this potential hazard are extremely important. The pest management professional is a line of defense that supports the food manufactures by inspecting, performing audits, identifying and preventing, improving and correcting hazards or situations that could cause damage, contamination or illness.

The consequences of not taking pest management seriously can be devastating to a food manufacturing company – resulting in fines, production shutdowns, closures and even bankruptcy filings. Not to mention a tarnished reputation, shaken confidence and public scrutiny of the brand and finished product. Certain failures may even create a system wide product recall compounding the negative effects.

The words ‘and’, ‘team’, ‘partner’ and ‘critical’ to describe the approach of a pest management professional and food manufacturing facility management and are key in understanding the role each plays – one to cut the risks and the other to protect, both helping each other accomplish the desired level of food safety.

Being proactive about food safety, including pest management, is paramount in protecting life and health. In the food safety industry food manufacturers work with a lot of different standards, protocols and regulations, such as Good Manufacturing Practices (GMPs), Standard Operating Procedures (SOPs), and Hazard Analysis Critical Control Point (HAACP). The standards are risk-based in order to address the issues as risks to public health and food safety due to activities of pests.

FDA is trying to level the playing field on food safety with the implementation of the Food Safety Modernization Act (FSMA) – the biggest change to food safety laws since the 1930’s – helping to bring together the various practices and governing agencies under a common goal – preventing food borne illness with sustainable and accountable improvements in food safety using prevention based controls.

As part of FSMA compliance, the pest management professional must be an integrated member of the food safety team. Thorough knowledge of the plant’s quality programs, manufacturing practices, approved product lists and sanitation programs is critical to success. Both pest management professionals and food manufacturing operations managers should also be aware of new pest control products and application techniques to fully offer the facility the best pest management program possible.

In all food manufacturing facilities, the pest management professional and manufacturing operations facility manager should both be prepared to:

  1. Work together with open communication.
  2. Provide training to both sides, whereas the plant team trains the pest management professional on the facility and processes with expectations of the service agreed upon. The pest management professional trains the food manufacturing team on basic pest management and where this fits into their food safety program and HACCP system.
  3. Set written expectations of services, treatments as well as a process for proper documentation. Utilize an appropriate accountability system of mapping and numbering all points of inspection, monitoring and treatment.
  4. Both parties should remain open to conversation regarding new and innovative techniques and treatment options that utilize the preventive intent of FSMA in conjunction with the concept of Integrated Pest Management (IPM).

The bottom line is that foodborne illness is largely preventable if everyone can be held responsible and accountable at each step they own for controlling hazards that can cause illness.

Traceability Requirements and Best Practices

By Michael Biros
No Comments

What is a traceability system and how is it related to a recall plan? Will FDA require electronic record-keeping? What does FSMA require FDA and industry to do in terms of traceability? These questions and more are answered by The Acheson Group in the latest FSMA Fridays webinar.

What are the latest updates on FSMA?
In response to the substantive nature of the public comments, FDA plans on proposing new versions of the Preventative Controls Rules for Humans and Animals.

The proposed Preventative Control rule requires a recall plan. Is traceability covered through mock recalls?
A recall plan and a mock recall are not the same as a traceability system. A traceability system focuses on the ability to know what came in from where and where it was sent. A mock recall is a much more involved process that looks at production records and many other factors. However, in order to do a robust recall, you need a functional traceability system. The Preventative Control rule requires a recall plan and other parts of FSMA require traceability systems. The two are related, but they are fundamentally different.

How does FSMA address traceability and why is traceability a part of FSMA?
Traceability is distinct from a recall plan and FDA will have to address it separately from the Preventative Controls requirements. Traceability is covered in Section 204 of FSMA which describes the detection and response to food safety problems. While there’s an element of prevention in having a good traceability system, it really focuses on the response side. Traceability continues to be an Achilles’ heel for the regulators. Many of the statute components that are built into FSMA are based on prior experiences and situations. The biggest debacle with traceability was the tomato/pepper issue in 2008 where not only was the commodity wrongly identified, but it took close to eight weeks to figure out that it was wrong.

In this instance, FDA struggled with not having adequate records and being able to do the traceability components correctly and quickly. This and other similar issues has caused the food safety pendulum to swing.

Traceability is essential. FDA would love for the traceability requirements to be more robust, but they are limited by what is economically feasible and practical. Looking to the future, it’s entirely reasonable that traceability requirements could be strengthened.

What does FSMA require FDA to do in terms of traceability?
Pre-FSMA, there are record-keeping requirements in place related to traceability coming from the Bioterrorism Act. Basically, the current requirements are one-up, one-down: where did you get the product from, where did you send the product to? In developing the traceability requirements of FSMA, Congress required FDA to conduct pilot studies to determine what practices and technologies work and what doesn’t. FDA also needed to look at the cost/benefit related to technology and changes in traceability systems and what was current practice both domestically and internationally. FDA has the authority through FSMA to require additional records be kept for high risk foods. We expect FDA to issue a proposed regulation for traceability and record-keeping with high risk foods sometime in the future.

What did the traceability pilots recommend and are those recommendations now in effect?
Ten recommendations were made to FDA based on the results of the pilot studies and stakeholder input. The first recommendation was that all foods should be designated as traceable, not just those that are designated as high risk. Another recommendation was that FDA should accept electronic records rather than going in person and getting photocopies and that FDA should develop a system for processing traceability data. It was also recommended that FDA work collaboratively with industry. Over the past few years, there have been several industry led efforts with varying levels of adoption that are generally moving towards standardized and electronic records-keeping systems. Finally, it was recommended that FDA identify subject matter experts to help the agency understand specific industries for when there is an issue with the supply chain.

None of these recommendations are currently in effect because FDA hasn’t released a proposed rule yet and is still reviewing the report and public comments. The full report is available for the public to view, but ultimately it is up to FDA whether they accept the recommendations and if/how they put them into regulation.

Will FDA require electronic record-keeping?
The agency does not have the statutory authority to require companies to use electronic record-keeping. FDA recognizes that electronic record-keeping is the way of the future and prefers it, but they cannot require it. They will let companies keep their records how they want as long as they can be produced within 24 hours if requested.

What should companies do today to prepare and what do you think FDA will do next?
Companies should read the IFT report, read the recommendations, and consider how they would have fared if they participated in the pilot studies. They should give some critical thought to how they would perform if there was an outbreak and they were the focus of a traceability study. Traceability is a byproduct of good record-keeping. If a company has an opportunity to make improvements, consider how traceability can factor in to those changes. Companies should talk to supply partners and understand the whole supply chain. Ultimately, the company is connected to all the other links in the supply chain and any one of those links can impact you.

Why GFSI? And How Can It Help?

By Jennifer Brusco
No Comments

The Global Food Safety Initiative or GFSI, simply explained, is a business-to-business Food Safety and Modernization Act (FSMA). It operates quietly and privately within the marketplace between the customers and their suppliers. It operates on not only a global basis, but also on a regional and local basis.

“Although people look at the [GFSI] program and see a lot of multinational corporate logos, frankly the majority of our operations are small and medium size facilities at the local level. So we welcome facilities of all natures – large, medium, and small, across the food to fork continuum,” Karil Kochenderfer, North American representative, GFSI, said during a recent webinar.

GFSI has approximately 25 benchmarked guidances, with some of the latest scope expansions include:

  • Packaging and animal conversion – August 2011;
  • Animal feed – June 2012;
  • Storage and distribution – October 2013;
  • Food brokerage/agents, retail/wholesale – early 2014; and
  • Catering, equipment manufacturing, food safety services – 2015.

Where are these guidances coming from? How can you be sure that these guidelines are science-based, risk-based, and address the issues in your plant/facility?

Why-GFSI-June2014At the very base of our efforts that are ensconced within these guidance on a sector by sector basis, are the international standards of science based within the Codex Standard on Food Hygiene. On top of that are Hazard Analysis and Critical Control Points or HACCP standards. Above HACCP are National Regulations, which includes FSMA in the U.S. and the Safe Food for Canadians Act in Canada. In Europe it’s something different, in Japan it’s something different, but all have iterative levels of science-based regulation in place to ensure the safest control of the food and management of the food. Above National Regulation is GFSI Certification.

“We go above and beyond the science of Codex, HACCP, and national regulation to perform at the highest level of industry. And our benchmarked schemes [eg. BRC Global Standards (BRC), Food Safety System Certification (FSSC 22000), International Featured Standards (IFS)] go beyond us and corporate programs go even further,” Kochenderfer highlighted.So what you have are several layers of protection that will help protect both consumers and companies.

What are some of the shared benefits for industry?

There are several benefits, which include:

  • Meet the requirements for one, meet the requirements for all;
  • Reduce duplication of audits;
  • Have comparable audit approach and outcomes;
  • Ensure the continuous improvement and customer opportunity for those GFSI-benchmarked companies;
  • Enhance trade opportunities;
  • Improve customer confidence in food safety; and
  • Gain cost efficiencies throughout the supply chain.

“We have now built confidence in third-party certification because we have reduced inefficiency in the food system. Now, it’s ‘Once Certified, Accepted Everywhere,'” stated Kochenderfer.

John Kukoly, Director of BRC in the Americas, added that companies should pursue GFSI certification for a number of reasons:

  • Customer mandate;
  • FSMA;
  • Nearly a 40 percent reduction in product non-conformance;
  • Competitiveness; and
  • Superiority in the market.

Right now, only a third of the industry has achieved GFSI certification, which leaves the remaining two-thirds either still at the starting line or just a few steps into their journey. How do you choose a GFSI-recognized scheme and get started?

Karil Kochenderfer shared a chart to allow users to see where they fall on the farm-to-fork continuum and further determine which scheme(s) would work for them.

Further, we have developed four GFSI checklists for the four major schemes that apply to food manufacturers, co-produced with the respective scheme owners to ensure accuracy and usability. The checklists are complimentary and may serve as a great resource on your journey toward GFSI certification.

Additional Resources:

FDA Access to Records Under FSMA

By Michael Biros
No Comments

What are the latest updates with FSMA and how has FDA’s access to records changed? Dr. David Acheson of The Acheson Group gives us the latest.

When it comes to latest updates regarding FSMA, the comment period on the proposed sanitary transportation rule has been extended to July 30, 2014.

What does FSMA change in terms of FDA access to records?

Before FSMA, FDA needed reasonable proof that a food would be adulterated and a threat of serious adverse health consequences or death to humans or animals (SAHCODHA) in order to access records.

Now, FDA needs reasonable probability that the use or exposure to a food, or any other articles of food that FDA believes is likely to be affected in a similar manner, would cause serious adverse health consequences. What FDA considers to be a reasonable probability will be determined on a case-by-case basis. These changes significantly expand the scope of what FDA can look at and lowers the threshold for records access.

Does FDA need to issue a formal request?

Formerly, FDA needed to invoke the Bioterrorism Act in order to gain access to records. This was a cumbersome process that required strict criteria to be met.

Currently under FSMA, FDA must provide written notice of what they are asking for. This documentation will be delivered by a credentialed FDA official.

Generally, access to records must be given as quickly as possible within 24 hours of the request. The records do not need to be in any particular format. Electronic records are still considered on-site records so long as they can be accessed from within the facility.

What can FDA ask for?

FDA has produced guidance documents that lists what they can ask for. FDA can request access to manufacturing records, ingredients receipt records, product distribution records, product inventory records, test records, recall records, reportable food records, customer distribution lists, and complaint/adverse event records.

There are some exceptions. FDA cannot request personnel records, financial records, recipes, some records from farms, and some records from restaurants.

How will FDA maintain the confidentiality of any protected information in records it obtains?

While some of these records may be accessible through the Freedom of Information Act (FOIA), FDA is responsible to protect and redact commercial confidential information in accordance with their own requirements. However, some of this sensitive information can be shared with other federal, state, local, and foreign authorities.

For more information, click here to see archived FSMA Fridays webinars, organized by SafetyChain Software.