Tag Archives: FDA

Microbiological Method Validation: The Elephant in the Lab

By Evan Henke, PhD, MPH
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Although commonly overlooked, microbiological method validation studies are the linchpins of entire quality programs, and method validations done without rigor are crippling our industry’s ability to truly ensure the quality and safety of foods on a daily basis.

Food quality managers, it is time we discussed the critical importance of validation studies in the quality lab. Although commonly overlooked, microbiological method validation studies are the linchpins of entire quality programs, and method validations done without rigor are crippling our industry’s ability to truly ensure the quality and safety of foods on a daily basis. This article discusses the purpose and importance of microbiological method validation studies and why the food industry should insist on validation study designs of maximum rigor and validity.

What is a microbiological method, and what exactly is a validation study?

A microbiological method, for the purposes of this discussion, is any microbiology test or assay used in the food industry. It may be a test for indicator organisms such as Coliforms or yeast and mold, pathogens such as Salmonella or E. coli O157, or toxins secreted by microorganisms such as Staphylococcal enterotoxin.

A validation study is a one-time study that food safety risk managers complete in order to assure themselves that a new microbiological method produces accurate results that will enable them to effectively measure and manage food safety risk. A validation study is conducted in the actual lab where testing will be performed, with current laboratory analysts, with the specific formulations of foods that are tested regularly.

Food industry regulators and certifying bodies such as SQF expect food producers to use microbiological test methods that are proven fit for use on specific foods. If we are to draw inferences about the fitness of a new test method on specific foods, then we must study how that new test method compares to an accepted reference method, or “gold standard” method. Reference methods are those written in the Food and Drug Administration’s Bacteriological Analytical Manual, the United States Department of Agriculture’s Microbiological Laboratory Guidebook, or ISO methods. Regulators and experts agree that these methods represent the standard to which all other tests should measure up. Methods certified by the Association of Analytical Communities (AOAC) are not considered reference methods and must be validated as fit for use on foods that are appreciably different from the matrices studied. Likewise, AOAC Performance Tested Method (PTM) and Official Methods of Analysis (OMA) certificates are not substitutes for internal validation studies in any given food plant.

In my experience working with quality labs across the United States, I have seen several different validation study designs used to evaluate alternative, more rapid and cost-effective microbiological methods. Some common validation study designs are shown in Table 1. Multiple alternative tests are available, however an internal validation study is needed regardless of the test kit manufacturer. Rarely does a validation study include a comparison to agar plates, which are required for almost every microbiological reference method. Material costs, labor costs, and emergency situations typically prohibit food labs from conducting a rigorous validation study that can speak to the performance of a new method in relation to the current gold standard.

Table 1: Scientific Questions Inherent in Food Microbiology Method Validation Study Designs 

 Validation Study Design  Inherent Scientific Question  Does Study Explain Performance
of New Test?
Test positive or spiked samples side by side on reference method and the new test  Does the test perform comparably to the reference method on my food? Yes 
Test positive or spiked samples on the new test  Regardless of accuracy, can the test detect certain or specific bacteria in my food?   No, but may be useful to understand workflow
Test any samples side by side on current AOAC certified method and new test  How do the new test’s results compare to my current AOAC certified method on my food?  No, but may be useful to understand workflow 
Test any positive or negative samples on the new test  Will the new test’s workflow improve my lab’s efficiency?  No, but may be useful to understand workflow 
This table presents several validation study designs common in the food industry and the scientific questions that are addressed by each design.

It is in the best interests of food producers and the public’s health to conduct rigorous validation studies that give food safety risk managers good information to make correct risk management decisions. In theory, some percentage of unsolved epidemiological foodborne illness clusters must be due to incorrect risk management decisions that allowed contaminated products to reach the market. At the same time, some percentage of all food lot rejections and recalls must be made incorrectly. A portion of these events must be related to food matrix interference that yielded incorrect microbiological results and caused the wrong risk management decision. As they say, “Garbage in, garbage out.”

In addition, including a comparison to agar reference methods in your microbiological method validation study is critical, as it reduces your chances of making an incorrect risk management decision.

Look at things this way: Plants certified with a GFSI accredited quality scheme have already put in effort to ensure analytical equipment such as thermometers and scales are calibrated. Similarly, validating microbiological methods against a reference method is equally if not more important. Finished product microbiology results inform decisions made every day that affect your profits and losses, and those results are likely a primary metric you use to study the effectiveness of your prerequisite programs and preventative controls.

Consider a quality lab that is using an alternative microbiological method that has not been rigorously validated with the plant’s specific foods. Unknown to the lab, the test results every day are twice as variable as the reference agar method and are frequently inaccurate relative to the plant’s product specifications. A rigorous method validation would demonstrate that results on the current method vary widely, while the same samples are consistent with a reference method. This well-intentioned plant is unknowingly making incorrect risk management decisions not just multiple times per year, but multiple times per week, either accidentally releasing contaminated product, reworking product that is acceptable, or disposing of perfectly good product. For the millions of dollars the food producer invests in prerequisite programs, preventative controls, quality personnel, and testing, the plant is unable to optimize their food safety risk management simply due to an unknown and overlooked incompatibility of the microbiological method with the plant’s product.

In my estimation, the costs of rigorously validating a microbiological method on all of your food products outweigh the potential hidden costs that could result from method incompatibility. The business case justifying the costs of a validation study are strong and compelling. And learning how to apply current microbiological methods specific to your foods is not as hard as you might think, considering the large host of test manufacturers, third-party labs, consultants, food safety extensions, and industry groups available to regularly provide study design education and services.

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.

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

By Food Safety Tech Staff
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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
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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.

Traceability Requirements and Best Practices

By Michael Biros
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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.

FDA Access to Records Under FSMA

By Michael Biros
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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

FSMA: What’s the Latest, and What Do You Need to Know

By Michael Biros
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Is your company ready for ‘TACCP?’ Do you know how long you will be required to retain your records? Is your carrier up-to-date on the sanitary transportation section of FSMA? Dr. Bob Strong, Senior Food Safety Consultant at SAI Global, gives an overview of the newest updates on FSMA.

Questions were raised recently by brewers and distillers about spent grains being sold as animal feed. FDA recognizes that hazards will be minimal, but charges facilities with protecting spent grains during storage awaiting collection and during transportation as required under FSMA Section 103. This will require protection against physical and chemical contamination and references the inadvertent addition of industrial waste oil to used fryer oil that exposed 100,000 chickens to PCBs. The comment period for this is closed and the final rule is expected to be published this summer. The final rule is scheduled to take effect by August 30, 2015.

Record retention and availability applies to anybody who processes, packs, transports, distributes, receives, holds, and imports human or animal food. However, farms, restaurants, USDA plants, personal consumption, non-food packaging, and food contact packaging manufacturers (but not users of this packaging material) are exempt from this requirement.

The length of record retention depends on the perishability of the food product. If the shelf life is less than 60 days, both the handler and transporter must retain records for 6 months. If the shelf life is between 60 days and 6 months or if the food is animal/pet food, both the handler and transporter must retain records for 12 months. If the shelf life is greater than 6 months, the handler must retain records for 2 years, but the transporter must retain records for only 12 months. Records must be available within 24 hours of a request by FDA and civil action may be taken if records are not kept or made available. This final rule was published on April 4, 2014.

FSMA section updates

These updates are confined to Section 106 — Intentional Adulteration of Foods; Section 111 — Sanitary Transportation of Human and Animal Food; and Section 204 — Designation of High Risk Foods Relative to Record-keeping for Traceability.

To recap, FSMA does not apply to facilities regulated by USDA (meat, poultry, and eggs). Also exempted are juice manufacturers, seafood processors, alcohol-related facilities, low-acid canning (except to expand their hazard analysis), and small businesses.

FDA is considering modified requirements for warehouses and having Preventative Controls only if they are storing refrigerated products.

Section 106 — Intentional Adulteration of Foods

The intent of the proposed rule is for companies to begin using a “qualified individual” to develop a written food defense plan. This plan will protect against intentional adulteration of food for the purpose of causing harm to consumers. The plan should focus on actionable process steps, mitigation strategies, monitoring, corrective actions, and verification.

The regulation exempts very small businesses, companies with a majority of sales to very small businesses, storage facilities (except for bulk liquid storage), alcoholic beverage manufacturers, and animal feed manufacturers and distributors.

Actionable areas and mitigation strategies:

Key actionable areas identified by FDA include: bulk liquid receiving and loading, bulk liquid storage and handling, secondary ingredient handling, and mixing and similar activities. Deliberate acts of contamination may come from acts of terrorism; disgruntled employees, consumers, or competitors; or economically motivated adulteration such as the melamine tainted milk incident.

Companies must identify and implement mitigation strategies, establish procedures to monitor these strategies, implement corrective actions, verify that monitoring is being conducted, train supervisors assigned to actionable process steps, and maintain records.

Examples of mitigation strategies include restricting access to potential adulteration points such as loading and receiving areas, bulk liquids, secondary ingredient handling rooms, and open processing points. Facilities must require tankers to be sealed after loading and the seals must be checked at receiving.


FDA is asking for comments on using HACCP principles to develop food defense plans. They are considering calling a control point a TACCP (Threat Assessment Critical Control Point). They are also trying to identify the risk of adulteration to specific processes. Some examples of low risk foods that are hard to adulterate are: shell eggs, whole produce, game meats (not ground), peanuts/tree nuts, and sugar cane/beets. FDA has extended the comment period through June 30, 2014. 

Section 111 — Sanitary Transportation of Human and Animal Food 

This section builds upon the previously issued Sanitary Food Transportation Act of 2005. It has five major sections: vehicle and transportation equipment, transportation operations, information exchange, training, and records.

The regulation exempts shippers, receivers, and carriers that have less than $500k in total annual sales; the transportation of raw agricultural commodities by farm vehicles; food being shipped through the US to another country; food imported to be exported, but not consumed in the US; shelf stable foods that are completely enclosed in a container; the transportation of compressed gases; and the transportation of live animals.

Vehicles and transportation equipment

The proposed rule will establish requirements for the design and maintenance of vehicles and equipment to ensure that they do not cause contamination of the food being transported. This includes bulk and non-bulk containers, bins, totes, pallets, pumps, fittings, hoses, gaskets, and loading/unloading systems.

The regulation identifies the potential for cross-contamination from: incorrect use of packing materials (reusing wood containers for produce that once held raw meat); using the same hoses or pumps with different allergens or raw and ready-to-eat products; and pallets in poor condition (splintering or projecting nails).

The proposed rule will establish requirements for cleaning, inspection, maintenance, loading/unloading, and operation of transportation equipment to ensure no contamination or temperature abuse of the products during transport. This includes the growth of spoilage bacteria as well as pathogenic bacteria. This will be achieved by ensuring adequate temperature controls, separation of foods with different temperature requirements, and the cleanliness and physical condition of trailers, tankers, pallets, etc.


Carriers, shippers, and receivers will be required to exchange information regarding prior cargos, the cleaning of bulk transportation equipment, and temperature controls. A log of prior loads must be kept. FDA will not restrict what can be hauled. Rather, they will regulate the cleaning between loads. Wash tickets must be kept and shared with customers. Washing may include sanitizing where necessary.

The carrier must communicate with the shipper and receiver that temperature sensitive foods were transported under the required temperature conditions. This requirement can be waived for short hauls or if the shipper loads a temperature recording device with the shipped products. The shipper and receiver are required to specify in writing the temperature requirements to the carrier. The receiver must confirm compliance.

Training, records and waivers

Carrier personnel must complete training in sanitary transportation practices and must have documentation of this training. This will include personal hygiene for drivers and loading/ unloading workers, training in security, accessibility to hand washing, and avoiding cross contamination in handling mixed loads. Procedures, training, cleaning, prior cargos, and temperature control must be recorded and properly maintained.

Shippers, carriers, and receivers who hold valid permits and are inspected under the National Conference on Interstate Milk Shipments (NCIMS) Grade “A” Milk Safety Program may be waived from these requirements only when they are involved in shipping Grade A milk and milk products. Transportation of food relinquished to consumers may also be waived (such as the pizza delivery guy).

Section 204 — Designating High Risk Foods for the purpose of record keeping related to Traceability

This proposed rule designates high-risk foods based on known food safety risks. The criteria for modeling and scoring risk are:

  1. Frequency of Outbreaks and Occurrence of Illnesses: This must include chemical and microbiological food safety hazards. Chemical hazards include allergens, mycotoxins, pesticides, and heavy metals.
  2. Severity of Illness: This will take into account illness duration, hospitalization, and mortality.
  3. Likelihood of Contamination: This is based on number of recalls and contamination that has been known to occur.
  4. Pathogenic Growth Potential/Shelf Life: Strong growth potential is likely at temperature at which the food is intended to be held and stored, including refrigeration and room temperature. This will be coupled with shelf life where longer shelf life can increase risk.
  5. Manufacturing Process Contamination Probability/Intervention: High probability has recurring or frequent detection of contamination. Low probability has infrequent detection of contamination or where contamination is introduced post manufacturing. This will be coupled with the availability and implementation of control measures.
  6. Consumption: This is the percent of the population that consumes the food.
  7. Economic impact: Lower is defined as $100-500k impact per year and higher is greater than $10m per year.

What Constitutes a Successful FDA Audit?

By Sangita Viswanathan
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From the proposed third party accreditation rule, to GFSI audits, and needing more trained and experienced auditors, the process of auditing food facilities is undergoing a sea-change. What is the impact going to be on food companies, auditors, and the auditing process?

In a recent FSMA Fridays webinar, sponsored by SafetyChain Software, an expert team from The Acheson Group, comprised of Melanie Neumann, J.D., M.S., VP and Chief Financial Officer; Jennifer McEntire, Ph.D., VP and Chief Scientific Officer; Anne Sherod, M.S., Director of Food Safety and Valerie Scheidt, MBA, CP-FS, Director of Food Safety, answered key questions on conducting successful FDA audits. We present some excerpts below.  

How does the FSMA third party audit accreditation rule impact the audit process?


The purpose of the third party accreditation and certification audit is to issue a certificate for high risk foods or the voluntary qualified importer program. The main foundation of the standards that FDA is setting will come from the human preventative controls rule, the animal preventative controls rule, and the produce safety rule. Some standards may also come from the sanitary transportation rule and food defense rule. FDA will be appointing an accreditation body and this accreditation body will approve and monitor certifying bodies (CB). These CBs can be private companies or private individuals who will be authorized by the accreditation body to perform the audits and issue those certifications. 

Foreign governments can also be approved by FDA to act as a CB. Right now only New Zealand is approved and FDA is looking at approving Canada. We don’t anticipate any other country to be approved in the near future.;

Certifying bodies will have strict conflict of interest and reporting requirements to FDA. CBs must report to FDA within 45 days even if they’re just performing a consultative audit. They must also report to FDA if they see an issue that could lead to a Class I or Class II recall and they have to report to FDA before they report to the company that they are auditing.


Will a GFSI audit satisfy FSMA audit requirements?

GFSI audit requirements do not match the FSMA audit requirements, but they are not too different. Several of the schemes are very similar, and each scheme owner is making a concerted effort to become FSMA compliant. If an auditor is doing a GFSI audit, they do not need report to FDA before the company. The FSMA requirements of avoiding conflicts of interest, record keeping, and training may deter GFSI auditors from becoming Certifying bodies under FSMA. Unless FDA offers an incentive, there will be a shortage of FSMA CB auditors. 


What are the elements of a successful audit?

The number one goal of an audit is to identify risk. The audit needs to accurately describe the non-conformances against the audit standard to give your quality and operations team reliable and actionable data so they can mitigate that risk. The relationship between the auditor and the facility should be a partnership, add value, and build trust. The facility should learn from the auditor and the auditor should understand what the facility is doing to mitigate risk and promote food safety. Continuous improvement takes the feedback from the non-conformances and evaluates them against the organization’s goal around risk. Whether the results are from an announced, unannounced, internal, second, or third-party audit, continuous improvement is critical, and this requires commitment from management and will help the facility become audit ready. 


How can I ensure my auditor is up to the task?

Most audits use checklists. This goes for both the auditor and the audited. The checklist provides a standardized list of what’s expected and adds an element of order and control to the audit. It also allows for an effective way to quantify metrics. 

However, using a checklist alone can lead to minimum risk finding. The auditor needs to find a balance between being strategic and prescriptive. In order to be effective, audit protocols need to be periodically reviewed and updated. This is especially relevant with FSMA and holds true for internal and third-party audits. Check to see if the auditor’s checklist is pre-FSMA or post-FSMA. Ask the auditor when was the last time that they reviewed and updated their audit protocols. 


Will we have enough good auditors to meet the need?

No, we already don’t have enough good auditors. The implications of this are that we may get substandard audits from substandard auditors. The current model isn’t working and we need a new approach. Currently, most auditors have extensive prior experience working in industry and often become auditors after they retire.

We are creating auditors not through structured training. This model is not sustainable and has limited growth potential. It will not provide the level of training required for GFSI or FDA third party certification requirement. We need a training program for auditors who come right out of school. We need people to go to school for food safety and be able to become an auditor after graduation. Food safety needs to be incentivized at the university level. There should be a bachelors degree in food safety auditing. We need structured training and developmental opportunities for folks earlier in their career rather creating auditors at the end of their career.

FSMA Sanitary Transport Rule: What You Need to Know

By Michael Biros
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Who does the proposed Sanitary Transport rule apply to and what will be its impact on the various transportation industries? This Q&A offers some insights and key takeaways from the critical rule.

On January 31, 2014, FDA announced the “Sanitary Transportation of Human and Animal Food” rule which will require certain shippers, receivers and carriers who transport food by motor or rail vehicles to take steps to prevent the contamination of human and animal food during transportation. The proposed rule establishes requirements for vehicle and transportation equipment, transportation operations, the exchange of information, training, written procedures and records. The proposed FSMA rule is broad and comprehensive and will likely have far-reaching effects across the food transportation industry.

In a recent FSMA Fridays webinar, sponsored by SafetyChain Software, Melanie Neumann and Jennifer McEntire, from The Acheson Group, answered some questions about the extent and implications of this rule.  We present some excerpts below. 

Who does the Sanitary Transport rule apply to?

Compared to other FSMA rules, the Sanitary Transport Rule’s coverage is broad and comprehensive. It will apply to businesses regulated not just by FDA, but by USDA as well. It will apply to food for human consumption as well as animal consumption. It will apply to both intrastate and interstate commerce. 

However there are a few exemptions: Companies with annual sales less than $500,000 and foods that are fully packaged and shelf stable are exempt. 

What impact will this proposed rule have on various transportation industries?

When it comes to Shippers and Carriers, this rule will affect everyone. Shippers need to establish and communicate with carriers about specific conditions for the food such as temperature control, cross-contamination control, hand-washing facilities for loading and unloading, etc. Carriers need to ensure that they are meeting the shipper’s requirements. They need to make sure equipment is appropriate and clean. Like other FSMA rules, this rule will require documentation. Carriers also need to complete a fair amount of training to establish how they can achieve these expectations. 

Receivers, historically, haven’t had a lot of responsibility in ensuring sanitary food transport. Now they have a regulatory obligation to do so. This rule will apply to anyone receiving food including retailers, food service, and small convenience stores. They will be required to actively participate and are subject to more regulatory oversight than they have had ever before. 

What is a waiver in the context of this rule and who might be eligible?

There are opportunities to receive a waiver and waive out of this rule. Those who qualify for a waiver are those who can prove that they are under other practices, protocols, and ordinances that ensure safe transportation of the food. For instance, businesses that transport USDA Grade-A dairy and pasteurized milk may qualify for a waiver. 

What are some key takeaways about the Sanitary Transportation Rule?

A lot of industry members have already implemented many of the best management practices that will be mandated by the proposed rule. Companies will need to focus on documentation and training. Companies will need to develop procedures to communicate requirements across shippers, carriers, and receivers. They will also need to develop training regimens and validation systems to ensure that these requirements are being met. Documentation is critical. In the eyes of a regulator, if it isn’t documented, it didn’t happen.

More information visit www.SafetyChain.com/FSMA-Fridays.

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

Is that Red Snapper on your Plate Really a Red Snapper?

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

Over the past few years, several consumer and news organizations have researched and tested seafood available in supermarkets and restaurants. The findings:

  • Some 35 percent of seafood samples in the U.S. were found mislabeled; 
  • Of the fish that were most commonly mislabeled, 
  • Red Snapper topped the list (at 86 percent being mislabeled);  
  • Nearly 16 percent of grouper was mislabeled; 
  • In one out of five cases, Atlantic or farmed salmon was substituted for wild or King salmon; and
  • “White tuna” was mislabeled 100 percent of the time. 

A more recent investigation into fish labeling fraud carried out in Europe revealed that 32 percent of seafood in Italy, 30 percent of all hake in Spain and 19 percent of cod in Ireland were mislabeled. Repeated studies have shown that these results are not one-off, but seafood fraud is consistent and not showing signs of any improvement.

E. Pearce Smith, Laboratory manager, GeneScan, at Eurofins talks about the challenges in testing seafood authenticity. There are a couple of issues with regards to seafood fraud, Smith says: “From an economic standpoint, you could be buying a cheaper fish (for instance a breaded tilapia fillet instead of a breaded grouper fillet) for more money. Also, from a quality point of view, you lose out.”

More importantly, Smith adds, from a food safety perspective, if you are unknowingly processing a wild grouper sandwich, you are not considering the right safety, microbiological and decomposition markers for the wild fish. Or if it is a farmed tilapia product, you are not looking at prohibited veterinary drugs in farmed fish.

The horsemeat scandal that rocked large regions of Europe in 2013 was the basis for this focus, Smith says. “With horsemeat being sold as beef, producers were not testing their beef products for bute or phenylbutazone, an anti-inflammatory used by vets mainly to treat pain and fever in horses.”

When testing is an art as well as a science

So far, seafood species authentication depended on tests that were developed many years ago. FDA published a protein method known as isoelectric focusing, in which you take a piece of a tissue, digest it into a slurry and run it out into a gel. By comparing the banding pattern to known references, you can conclude what kind of fish it is. The problem with this technique, Smith says, is that it is often inconclusive, or at least open to interpretation in many cases.

So, about three years ago, FDA decided to abandon this 1950s technology for a more modern technology – DNA barcoding.  So now, instead of using a protein pattern, the test involves isolating the DNA and amplifying a specific section of it for analysis. 

“In a relatively short sequence, of about 700 base pairs, it’s very easy to distinguish one species of fish from another,” Smith says, adding that now food companies want to drive the switch from the protein testing to the DNA method.  Testing for the protein requires a lot more hands-on time and testing one sample can take several hours, Smith explains. “With the DNA method, you can automate the testing to a much higher degree to handle hundreds of sample a day. And with the cost of sequencing dropping, such testing is no longer cost-prohibitive,” he adds.

Robust methodology

The new methodology is robust because DNA is a very stable molecule, according to Smith. “You can test raw or cooked fish with this method, while the protein test was not as good at spanning the pre- to post-processed product. You can also test a finished product such as a frozen fish dinner.”

What are the limitations? Smith lists a few examples: Testing a food product that could have multiple types of fish, such as a fish cake or Surimi, which are ground up into a paste, and could have multiple seafood products in them. Canned tuna is not suitable for testing, because the high pressure process involved is very destructive and you may not be able to get a nice clean read of the DNA. FDA has identified about 150 unique species as targets for substitution, or of high commercial value at risk of being substituted for monetary gains.

“The samples that we get from food producers usually turn out to be what we expect them to be, but sometimes, they don’t. When we get samples from consumer groups, about 30 percent are mislabeled. Also, variations in regional names for that particular fish also contribute to confusion and mislabeling,” Smith explains.

FDA is now publishing the reference sequences for the different species of fish to make identification quicker and easier. Earlier people had to rely on private databases and some of these, while good, weren’t easily accessible. 

Smith sees a lot of demand for testing species such as salmon (differentiating pink salmon Oncorhynchus gorbuscha, Chinook salmon Oncorhynchus tshawytscha, or Coho salmon Oncorhynchus kisutch); and red snapper (which faces high demand but is low in supply, and is commonly substituted with other fish of the same size or color). He says that the importance for this testing is growing increasingly as companies are importing seafood product, and it is critical that the species be correctly identified on the packaging. Imports are the source of as much as 90 percent of the fish consumed in the U.S., and only about 2 percent of those products are inspected, he adds.