Tag Archives: Focus Article

Department of Justice seal

Seeking Deterrent Effect, DOJ Targets Cases that Have Big Influence

By Maria Fontanazza
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Department of Justice seal

As the Department of Justice (DOJ) continues to prioritize prosecution against food companies that have been involved in recalls and foodborne illnesses, many often wonder how exactly the department decides which companies it will pursue and why. The most notorious recent example is the case against the Peanut Corporation of America (PCA) in which the sentencing of the company’s executives was said to have set a precedent for the industry. One of the reasons the DOJ went after PCA was due to its widespread distribution of food and the fact that the illnesses and deaths were all over the country, according to Michael Blume, director of the consumer protection branch of the DOJ.

“Did any of you hear about [PCA] before the outbreak?” Blume asked the audience at the GMA Science Forum last week. “Consumers have very little ability to protect themselves from foodborne illness. PCA was in all kinds of brands—crackers, Kelloggs, [etc]. For those reasons, we were much more concerned about preventing these kinds of outbreaks and what could the DOJ do about it.”

When assessing contenders for criminal prosecution, there are several common factors that encourages the DOJ to dig deeper:

  • The amount of harm. Has the sale of contaminated food has led to a great deal of illnesses or deaths?
  • Has the company had problems in the past? If it is a first time occurrence, the DOJ is less likely to pursue a case, but if there is a history, “we’re going to look harder,” said Blume. For example, if a government agency or another party has identified a problem, and then the FDA also sees the problem and issues a 483. Then five years later, the company still has not fixed the problem.
  • Similarly, if the DOJ sees that the company has identified internal problems and has chosen not to fix them, and as a consequence, these actions lead to the sale of contaminated food.
  • Where does the company sit in the market? “We can’t [pursue] every case, we have to think about what case will be most impactful,” said Blume. “What case will signal to the rest of industry that there are things they need to think about? If it is a company that people think have a good reputation, etc—to give a signal to industry—there are things that even the very best in industry can run afoul.”
  • If there’s evidence that the company has misled any party. This doesn’t apply to a government body only—it could also be the company’s vendors.
  • The general culture. Although this concept is intangible, the DOJ considers a company’s reputation in the industry and the relationship it has with regulators. Are they trying to fix issues and maintain compliance? That will make a difference and will be weighed in the company’s favor versus companies that choose to ignore problems.

“The DOJ thinks very hard about charging individuals. If there’s a criminal investigation targeting a company, you have to be concerned about who acted within the company and what their role was.” ­– Michael Blume, DOJ

Of course, food companies would like to avoid the heavy hand of the DOJ and for that, Doug Fellman, partner at Hogan Lovells US, LLP, offered several points of advice:

  • Be on guard for red flags that suggest a compliance-related environment in which the company is at risk for having problems. If employees are raising concerns at the facility or about the manufacturing process, don’t let people write those individuals off.
  • Be careful about how any decisions will look in hindsight. Stop on a real-time basis and look at how it will appear in retrospect.
  • If in a recall situation, decisions must be made quickly. Be careful that any decision making won’t to come back and bite the company when someone looks at it with the benefit of time.
  • Always be truthful and candid with the regulators.
  • Ask yourself whether you really know the conditions at the facility. Do people have visibility to what’s happening there?
  • Beware of emails. “Emails form the basis of almost every case I have,” cautioned Fellman.

Should the DOJ show up at your facility, it’s important to be polite and act professional towards agents. Although this may seem obvious, whether or not the agents immediately encounter pushback makes a difference, advised Blume. That said, it’s important to have protocols in place in the event that the DOJ shows up either at a company facility or even at an employee’s doorstep. “We get great evidence from a knock at someone’s door who doesn’t know what to say or when we do an inspection and people don’t know what to do,” said Blume. It’s prudent to discuss in advance when to seek the advice of a lawyer, because the more prepared a company is in handling such an issue, the less likely it is to make incriminating statements.

DNA sequencing

Whole Sample Next-Generation DNA Sequencing Method: An Alternative to DNA Barcoding

By Casey Schlenker, Jenna Brooks, Kent Oostra, Ryan McLaughlin
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DNA sequencing

This article discusses a non-targeted method for whole sample next generation DNA sequencing (NGS) that does not rely on DNA barcoding. DNA barcoding requires amplification of a specific gene region, which introduces bias. Our non-targeted method removes this bias by eliminating the amplification step. The applications of this method are broad and we have begun optimizing workflows for numerous materials, both processed and unprocessed. Some of the materials we have been able to successfully identify at the species level are fish tissue, fish meal, unrefined fish oil, unrefined plant-based oils (nuts, seeds, and fruits), specific components of cooked and processed products such as cookies and powders, and processed meats. Non-targeted NGS is also a very powerful tool to comprehensively identify constituents of microbial communities in probiotics and fermented products like kombucha. Additionally, this non-targeted technique is applicable to detection and identification of microbial contamination at various levels of manufacturing including equipment surfaces, processing water and assaying intermediate processing steps. In this communication we briefly review a current issue in the botanicals industry, discuss the methods that have been used in the past to tackle that problem, and present preliminary results from a pilot study we performed to determine the utility of non-targeted NGS in high-throughput identification of botanical raw materials.

The value of the global herbal dietary supplement (botanical) market was estimated to be greater than $90 billion in 2016, with a projected compound annual growth rate of 5-6%. Currently, regulators and manufacturers in this rapidly expanding market seek to confirm the veracity of label claims, investigate fraud, identify adulterants and ensure product quality.1 These products are often dried and ground, making visual identification difficult, time consuming and sometimes impossible.2 It is critical to this market that botanical identification be high-throughput, accurate and cost effective. Historically, various chromatography techniques have been used to meet this need, but those techniques rely on identification of molecules that can vary significantly due to storage conditions, which has led to the use of DNA barcoding as an analytical technique. However, DNA barcoding is not without significant challenges.1

For quite some time, scientists have had the ability to identify biological samples by sequencing their DNA.3 Currently DNA sequencing-based identification methods rely heavily on a technique called DNA barcoding, which functions analogously to the barcodes found on products in a grocery store. DNA barcoding amplifies a distinct small gene region that serves as a unique identifier and “scans” it by DNA sequencing.4 The advantages of this amplification are high sensitivity and simplification of data analysis. However, this amplification is not completely reliable and in practice can create biases and false positives.5 There is also the possibility that the amplification may fail, causing false negatives.6 When using DNA barcoding to identify botanical raw materials, numerous labs have observed notably high levels of apparent contamination.7 While it is certainly likely that some or even many botanical raw material samples contain contamination, it is also possible that the amplification-based method of DNA barcoding is itself contributing to the levels of contamination that are being observed.

We have partnered with Practical Informatics and Pacific Northwest Genomics to develop comprehensive whole sample DNA screening methods that don’t rely on amplification. To achieve this we are utilizing a non-targeted metagenomics workflow. Non-targeted metagenomic analysis is a powerful tool for examining the entire genetic content of a sample, instead of just one particular gene region (if a gene is a word or phrase, then a genome is the entire book, and the metagenome is the library). Unlike DNA barcoding, which requires PCR amplification, non-targeted metagenomic analysis requires no prior knowledge of a sample’s source and does not introduce the biases that plague PCR initiated methods. All of the DNA extracted from a sample is analyzed without targeting any particular gene region, relying instead on complex data analysis to identify the constituents (Figure 1). This is accomplished with the use of advanced molecular biology techniques and sophisticated computational methods, combined with a highly-curated database of species-identifying DNA sequences. Our research and development team has completed several experiments demonstrating the utility of a non-targeted DNA sequencing method.

DNA sequencing
Figure 1. The traditional targeted method, or DNA barcoding uses a PCR amplification step prior to sequencing. Non-target whole sample sequencing skips the amplification step and all present DNA is sequenced and used in analysis.

Our research endeavors to solve the issues of DNA sequence analysis that originate with the PCR step by simply eliminating amplification from our process entirely. PCR amplification as a prelude to DNA sequencing traces to traditional technologies that were lower throughput and required large amounts of material. Current generation high-throughput DNA sequencing technologies do not require large amounts of starting material, and therefore amplification can be avoided. Many DNA barcoding methods require universal primers, which, during PCR, can amplify some products but not others, leading to false negatives. A solution to that issue is to use specific primers, however this is also inherently problematic as a certain foreknowledge of the sample identity is required. What is the advantage to our non-targeted sequencing method? There is no need to direct the analysis to any particular identification before sequencing, decreasing the introduction of bias and false negatives. As an added bonus, we don’t need to know what the sample is prior to analysis—we can tell you what it is rather than you telling us.

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Reduce Foodborne Illness Causing Microorganisms through a Structured Food Safety Plan

By James Cook
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In 2011 three U.S. government agencies, the CDC, the FDA and the USDA’s Food Safety Inspection Service (FSIS) created the Interagency Food Safety Analytics Collaboration (IFSAC). The development of IFSAC allowed these agencies to combine their federal food safety efforts. The initial focus was to identify those foods and prioritize pathogens that were the most important sources of foodborne illnesses.

The priority pathogens are Salmonella, E. coli O157:H7, Listeria monocytogenes and Campylobacter. To research the most important product sources, the three agencies collaborated on the development of better data collection and developed methods for estimating the sources of foodborne illnesses. Some of this research was to evaluate whether the regulatory requirements already in effect were reducing the foodborne pathogens in a specific product matrix. The collection, sharing and use of this data is an important part of the collaboration. For example, when the FDA is in a facility for routine audit or targeted enforcement, they will generally take environmental swabs and samples of air, water and materials, as appropriate, which are then tested for the targeted pathogens. If a pathogen is found, then serotyping and pulsed-field gel electrophoresis (PFGE) fingerprinting is performed, and this is compared to the information in the database concerning outbreaks and illnesses. This data collection enables the agencies to more quickly react to pinpoint the source of foodborne illnesses and thereby reduce the number of foodborne illnesses.

The IFSAC strategic plan for 2017 to 2021 will enhance the collection of data. The industry must be prepared for more environmental and material sampling. Enhancement of data collection by both agencies can be seen through the FSIS notices and directives, and through the guidance information being produced by the FDA for FSMA. Some examples are the raw pork products exploratory sampling project and the FDA draft guidance for the control of Listeria monocytogenes in ready-to-eat foods.

Starting May 1 2017, the next phase of the raw pork products exploratory sampling project will begin. Samples will be collected and tested for Salmonella, Shiga-toxin producing E. coli (STECs), aerobic plate count and generic E. coli. In the previous phase, the FSIS analyzed 1200 samples for Salmonella for which results are published in their quarterly reports. This is part of the USDA FSIS Salmonella action plan published December 4, 2013 in an effort to establish pathogen reduction standards. In order to achieve any objective, establishing baseline data is essential in any program. Once the baseline data is established and the objective is determined, which in this situation is the Health People 2020 goal of reducing human illness from Salmonella by 25%, one can determine by assessment of the programs and data what interventions will need to take place.

The FDA has revised its draft guidance for the control of Listeria monocytogenes in ready-to-eat food, as per the requirement in 21 CFR 117 Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Foods, which is one of the seven core FSMA regulations. Ready-to-eat foods that are exposed to the environment prior to packaging and have no Listeria monocytogenes control measure that significantly reduces the pathogen’s presence, will be required to perform testing of the environment and, if necessary, testing of the raw and finished materials. Implementing this guidance document helps the suppliers of these items to cover many sections of this FSMA regulation.

The purpose of any environmental program is to verify the effectiveness of control programs such as cleaning and sanitizing, and personnel hygiene, and to identify those locations in a facility where there are issues. Corrective actions to eliminate or reduce those problems can then be implemented. Environmental programs that never find any problems are poorly designed. The FDA has stated in its guidance that finding Listeria species is expected. They also recommend that instead of sampling after cleaning and/or sanitation, the sampling program be designed to look for contamination in the worst-case scenario by sampling several hours into production, and preferably, just before clean up. The suggestion on this type of sampling is to hold and test the product being produced and to perform some validated rapid test methodology in order to determine whether or not action must be taken. If the presence of a pathogen is confirmed, it is not always necessary to dispose of a product, as some materials can be further processed to eliminate it.

With this environmental and product/material testing data collected, it is possible to perform a trends analysis. This will help to improve sanitation conditions, the performance of both programs and personnel, and identity the need for corrective actions. The main points to this program are the data collection and then the use of this data to reduce the incidence of foodborne illness. Repeated problems require intervention and resolution. Changes in programs or training may be necessary, if they are shown to be the root cause of the problem. If a specific issue is discovered to be a supply source problem, then the determination of a suppliers’ program is the appropriate avenue to resolve that issue. Generally, this will mean performing an audit of the suppliers program or reviewing the audit, not just the certificate, and establishing whether they have a structured program to reduce or eliminate these pathogens.

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Zia Siddiqi, Orkin
Bug Bytes

Stored Product Pests May Be Lurking in Your Facility

By Zia Siddiqi, Ph.D.
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Zia Siddiqi, Orkin

Pests can be sneaky. Many can compromise food products without anyone realizing they’re present. This is bad news for food processing facilities where an abundance of food products can translate into high pest pressure.

Beetles and moths are two of the main offenders in this environment and are referred to as stored product pests. These creatures can cause safety and legal concerns if they find their way into products, as they are quite adept at doing. They can damage packaging and cause product contamination or alter the taste of products when they secrete chemicals from their bodies, as many do.

This is not only a concern for your business’s reputation and bottom line, but could cost you major points on your next audit. Especially under the new FSMA regulations, prevention must be the emphasis in all U.S. facilities. This represents a shift from previous regulations as the new ones require risk-based preventive controls.

Integrate pest management
Does your company have an integrated pest management plan? Image courtesy of Orkin

The best way to prevent stored product pests and adhere to FSMA regulations is by implementing an integrated pest management (IPM) program. IPM programs focus on proactively preventing pests by inspection, monitoring and eliminating conditions that attract or harbor them using tactics like exclusion and sanitation, using chemicals only as a last resort. Under FSMA, you need to identify potential roadblocks and actively work to remove them. Showing constant improvement over time is an absolute must.

These programs also call for comprehensive documentation to monitor pest issues and ensure improvements are made over time. Auditors love to see documentation, as it shows that you are consciously working to strengthen your pest management efforts with continual improvement. If your facility doesn’t have an IPM program, it’s time to make a change sooner rather than later.

To successfully prevent stored product pests, you need to understand what they are and why they are attracted to your facility.

Types of Stored Product Pests

There are many different species of stored product pests, but they can be classified by four main categories based on their biology and habits:

  1. Scavengers: Eat just about anything, even if other pests have been there first. Pests in this category include the red flour beetle and sawtoothed grain beetle.
  2. External feeders: Feed on the exterior of cereal (grain) and kernel products and work their way inside. Pests in this category include Indian meal moths and cigarette beetles.
  3. Internal feeders: Lay eggs in the grain and feed on kernels from inside. Pests in this category include granary weevils, lesser grain borers and Angoumois grain moths.
  4. Secondary feeders: Eat from the outside in and consume moldy and damp food products. Pests in this category include spider beetles and fungus beetles.

How do you know if you have stored product pests? An infestation becomes apparent when the pests can be observed crawling or flying around. At this point, it’s important to identify the specific species that is plaguing your facility, as this will dictate the appropriate treatment method.  A trained professional can help correctly identify the species and recommend the best course of action to resolve the problem. Stored product pests reproduce quickly, so it’s critical to address any infestations before they have time to multiply and contaminate additional product.

The most common stored product pests are:

  • Sawtoothed Grain Beetle. Can burrow directly through boxes and packaging, so even sealed foods are at risk. They prefer processed food products like bran, chocolate, oatmeal, sugar and macaroni.
  • Indian Meal Moths. One of the most common pests for food processing facilities, the larva feeds on a large variety of different products. Some distinctive signs of an infestation are silk webbing and frass near the surface of the product.
  • Cigarette and Drugstore Beetles. Also able to chew through packaging, these beetles prefer pet food, spices, tobacco and any packaged food.
  • Granary and Rice Weevils. Prefer whole grains or seed products like popcorn, birdseed and nuts. They are recognizable by a snout protruding from their head and their reddish-brown bodies. Grains infested by weevils will be hollow and have small holes.
  • Spider Beetles. Similar to small spiders in appearance, they prefer grains, seeds, dried fruits and meats. They often accompany a rodent infestation because they prefer grain products that are old and moist.

Prevention Tactics

To help prevent stored product pests, incorporate the following tactics as part of your IPM program:

  • Closely inspect incoming shipments and packages. Look for the signs of stored product pests, like webbing, larvae and live adult insects. Check for signs of damage, especially for holes that can be caused by boring pests. To monitor for pests entering in this way, a quality assurance sample should be placed in a closed, labeled plastic container for later observations to see if any activity is noticed. This will give you a better idea if pests are present and what types may be being introduced via the incoming shipment.
  • Use of pheromone traps. These are the best tool to monitor the pest activity. These traps can also be placed in transportation vehicles to see if the trucks have a resident stored product pest population.
  • Use temperature as a repellant. Most stored product pests cannot live in extreme temperatures. If storage rooms can be maintained at 60°F or lower, stored product pests won’t be able to establish themselves inside.
  • Practice the first-in, first-out (FIFO) approach for products. Deteriorating products are an invitation to stored product pests, so make sure that older products go first and remove any with damages. It is also best to store products off the floor and more than 18 inches from walls, as it makes it easier to clean the surrounding area.
  • Create a sanitation schedule. Keeping a facility free of food debris will go a long way in eliminating attractants for pests. Clean up product spills immediately, and vacuum and wipe down everything on a regular basis. Don’t forget the cracks and crevices!

Keep in mind that being proactive is an important part of this entire process. If you see something, say something. Resolving pest issues as quickly as possible will be beneficial in the long run, as infestations are naturally more difficult to remove and could cost your facility dearly during an audit. A pest management professional will be able to point out the hot spots around a facility and can help to ensure that proactive prevention tactics are in place before anything gets out of hand. If any products are compromised, discard them immediately.

Pest Management: A Team Effort

The stakes are high in the food processing environment, which means pest control must be a priority. The most successful pest control programs are a team effort. Form a strong partnership with your pest management provider and work closely with them throughout the year to proactively prevent pest problems. Reach out to them early and often if you suspect any issues.

It’s also important that your entire staff is aware of pest management initiatives and tactics, which is why many pest management providers offer free staff training courses upon request. Take advantage of the resources available through your provider.

Working with a pest management provider to create a customized, IPM plan will help prevent pests and in turn protect the quality of your products and your business.

Vulnerability assessment

Protecting Food Against Intentional Adulteration: The Vulnerability Assessment (Part One)

By Debby L. Newslow
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Vulnerability assessment

FDA, as part of FSMA, released its rule titled “Protecting Food Against Intentional Adulteration” on May 27, 2016. This rule was proposed in 2013. FDA received and responded to 200+ comments prior to its final release.

FDA states that this rule “is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Such acts, while not likely to occur, could cause illness, death, [and] economic disruption of the food supply absent mitigation strategies.”1

The rule requires a documented “Food Defense Plan” that at a minimum includes the following:

  • Vulnerability assessment
  • Mitigation strategies
  • Procedures for food defense monitoring
  • Food defense corrective action procedures
  • Food defense verification procedures
  • Records confirming implementation, maintenance and conformance to the defined requirements
  • Evidence of effective training

As a food safety professional with more than 30 years in the industry, reviewing this rule brought back many memories. These memories combined with information gained from a recently completed Food Defense/ Crisis Management workshop presented by Rod Wheeler really set my brain into motion.2

Years ago, industry focused on crisis management and product recall. Requirements included having a crisis management team that was led by associates representing both upper and middle management. In addition, most programs included the following:

  • Posted identification of the crisis management team (i.e., pictures, phone numbers, etc.)
  • Specific training for receptionist and guards
  • Mock crisis exercises (i.e., fire drills)
  • Planned crisis calls to the operation’s direct incoming phone numbers (i.e., receptionist and guards)
  • Mock recalls (from supplier through finished product and distribution)
  • Security inspections which may now be considered the pre-cursor to today’s “Vulnerability Assessment”

With the introduction of the GFSI approved schemes (FSSC 22000, BRC, SQF, GlobalG.A.P., Primus, etc.), requirements for crisis management, emergency preparedness, security programs, food defense training and continuity planning gained an increase focus. Do any or all of these programs meet the requirement for a “vulnerability assessment”?

In the 2013 publication, Food Safety Management Programs, this subject-matter chapter was titled “Security, Food Defense, Biovigilance, and Bioterrorism (chapter 14)”.3 An organization must identify the focus/requirements that are necessary for its operation. This decision may relate to many different parameters, including the organization’s size, design, location, food sectors represented, basic GMPs, contractor and visitor communication/access, traceability, receiving, and any other PRP programs related to ensuring the safety of your product and your facility. Requirements must be defined and associates educated to ensure that everyone has a strong and effective understanding of the requirements and what to do if a situation or event happens.

Confirming the security of a facility has always been a critical operational requirement. Many audits have been performed that included the following management statement: “Yes, of course, all the doors are locked. Security is achieved through key cards or limited distribution of door keys, thus no unwanted intruder can access our building.” This statement reminds me of a preliminary assessment that I did not too long after the shootings at a Pennsylvania manufacturer in September of 2010. The organization’s representor and myself were walking the external parameter of a food manufacturer at approximately 7:30 PM (still daylight). We found two doors (one in shipping and one accessing the main office), with the inside door latch taped so that the doors were not secure. The tape was not readily evident. The doorknob itself was locked, but a simple pull on knob opened the door. Our investigation found that a shipping office associate was waiting for his significant other to bring his dinner and was afraid that he would not be at his desk when she arrived. An office associate admitted that that door had been fixed to pull open without requiring a key several months earlier because associates frequently forgot their keys and could not gain access to start work.

Debby Newslow Debby Newslow will present ” Sanitary Transportation for Human & Animal Food – Meeting the new FDA Requirements” at the Food Safety Supply Chain Conference  | June 5–6, 2017 | Attend in Rockville, MD or via webcast | LEARN MORE

We also observed a large overhead door adjacent to the boiler room along the street side of the facility open, allowing direct access to the processing area by passing through the boiler room and then the maintenance shop. It was stated that the door had been opened earlier in the day waiting for the delivery of new equipment. No one at the time knew the status of the shipment or why the door was still open.

Finding open access to facilities is becoming more and more common. A formal vulnerability assessment is not necessary to identify unsecured doors (24/7) in our facilities. Education and due diligence are excellent tools for this purpose.

Another frequently identified weakness is with organization’s visitor and contractor sign-in prerequisite programs. What type of “vulnerability” are we creating for ourselves (false confidence) with these programs? Frequently these programs provide more questions than answers:

  • Does everyone really sign in?
  • What does signing the visitor log mean?
  • Are visitors required to show identification?
  • Are the IDs actually reviewed and if so, what does this review include?
  • Who is monitoring visitors and contractors and are they trained?
  • Do all contractors have to sign the log or are they allowed to access the building at different locations?
  • Do those contractors who make frequent or regular trips have their own badges and/or keys (keycards) so they don’t have to take the time to sign-in (i.e., pest control, uniform supplier vending services)?
  • How are contractor badges controlled?
  • Are visitors required to be accompanied during the visit or does it depend on the visitor and whom they are visiting?
  • Are visitors and contractors trained in company requirements?
  • Do visitors and contractors have an identifying item to alert your associates of their status (i.e., visitor badge, visitor name badge, specifically colored bump cap, colored smock, etc.)?
  • How are truck drivers monitored? Do they have a secured room for them or do they have complete access to the facility to access the restrooms and breakroom?
  • How are terminated associates or associates that have voluntarily left the company controlled?
    • Can these associates continue to access the facility with keys, access cards, or just through other associates (i.e., friends or associates that did not know that they were no longer an employee)?
  • How many more questions can there be?

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Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

Five Things to Look for in a Trading Partner

By Shawn K. Stevens
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Shawn K. Stevens, Food Industry Counsel

Any ready-to-eat food product is only going to be as safe as the ingredients used to manufacture it. Unfortunately, most companies spend most of their money and time focused on broadening their customer base at the expense of properly screening new or existing suppliers. These companies fail to recognize that the single most significant threat to their company is failing to avert a potentially disastrous supplier problem that is lurking just outside of view. Whether your supplier has an inadequate food safety system or a poor food safety culture, such failures can cause your supplier’s products to become contaminated with deadly pathogens. In turn, if you are sourcing any products from that supplier, its food safety problems will inevitably become your own.

So, what should you do to ensure that your supplier’s food safety problems do not become your own?  Over the past two decades, I have witnessed countless food safety failures cause countless more outbreaks and recalls. Most of these outbreaks and recalls could have been avoided by the companies that were affected simply by taking a few extra precautions. Thus, throughout the years, I have developed the following recommendations that all companies who manufacture or sell ready-to-eat products should follow when they are screening new or existing suppliers.

First, visit each of your suppliers’ facilities and make sure that they are producing your products in a clean and sanitary environment. If the facility is old, worn and has significant maintenance issues, consider moving to a different supplier. Poor facility construction, or the failure to maintain a cleanable and sanitary environment in weathered facilities, remains one of the most significant causes of product contamination. Microorganisms can take hold and easily find residence in older facilities that are not being appropriately maintained. In turn, once harmful pathogens become entrenched in environments that are difficult to clean and sanitize, it becomes extremely difficult to root them out.

Second, make certain that each of your suppliers have a robust environmental monitoring program. The only way for your supplier to prove to you that its sanitation program is effectively controlling microorganisms in the environment is to test and to test often. Unfortunately, many suppliers’ testing programs are woefully inadequate because the suppliers test too infrequently or only after cleaning and sanitation. As a result, in addition to requiring that each of your suppliers implement a robust sampling program, you should also require each of your suppliers to sample their food processing environments at least three to four hours into production. This way, they will always have an accurate picture of the sanitary conditions of the processing area during production.

Third, be sure to only partner with suppliers who are willing to test their finished products before selling them to you. If a supplier has confidence in its sanitation and monitoring programs, then that supplier should be willing to test the products it is selling you. If, however, your supplier refuses to test its finished products, it signals that the supplier does not believe it is able to produce a ready-to-eat product that is consistently free from contamination. Thus, if you ask your supplier to test its ready-to-eat products for the presence of harmful pathogens, and it refuses, immediately take your business elsewhere.

Fourth, inquire about your supplier’s suppliers. Remember, a platoon is only as fast as its slowest runner. If any supplier in the distribution chain has a problem, that problem will affect every company located downstream from the failure. Thus, be sure to get a commitment from each one of your suppliers that it will impose the same requirements on each of its own suppliers, and then verify that your supplier is actually doing what is promised.

Fifth, make sure only to do business with those suppliers that can demonstrate they have a strong food safety culture. The best way to judge the strength of a supplier’s food safety culture is by inquiring about the structure and credentials of the supplier’s food safety team. If the person in charge of food safety for the supplier is well credentialed, has deep experience, and is supported by a well-qualified team, that demonstrates that the supplier takes food safety seriously. If, however, the supplier does not have a food safety director, his or her resume is weak, and he or she does not appear to have adequate support, then the company likely lacks any food safety culture whatsoever. In this case, it would be advisable to find an alternative supplier that has invested in the right people and put them in the right positions.

In the end, the best way to protect your products and brand is to only use suppliers that are appropriately vetted and screened. If you commit to only using suppliers that have invested in clean and sanitary facilities, robust environmental and finished product testing programs, and strong food safety cultures, then you will likely be able to virtually eliminate the chances that your products will be associated with an outbreak or recall. If, however, you choose to leave your suppliers’ food safety performance to chance, your suppliers problems (and, they will have problems) will inevitably become your own.

Shawn Stevens will be speaking during a webinar on this topic, Contracting With a New Trading Partner? Here’s Your Risk-Reduction Checklist, May 2, 2017, 1–2pm ET. Register now.

Phil Moyer, Unyson
FST Soapbox

Six Considerations When Choosing Your 3PL Provider

By Phil Moyer
2 Comments
Phil Moyer, Unyson

The third-party logistics provider  (3PL) market is expected grow at a compound annual growth rate of more than 5% through at least 2024, according to Hexa Research. In addition, Aberdeen Research reports that industry leaders have increased the number of 3PLs they work with by more than 20% since 2013. Clearly, companies are outsourcing more of their logistics activities, and there are many factors to consider when choosing a 3PL, especially in the food industry. This article discusses a few essentials to take into account before betting your company reputation on a new 3PL relationship.

1. Experience

Transporting food is a serious and complex business, and it’s one place you don’t want to be a trailblazer. If the 3PL you’re considering doesn’t have extensive experience with products similar to yours, you are better off looking elsewhere. After all, it’s your reputation that will take the hit if things go wrong. This is one area where it pays to check references.

A company’s supply chain can be the weakest link in its food safety program. Learn how to mitigate these risks at the Food Safety Supply Chain conference | June 5-6, 20172. Familiarity With Food Safety

First and foremost, ensure your 3PL understands the ramifications of the latest legislation regarding food handling — including FSMA and HACCP. It should be able to point to material handling data sheets for every item of food it handles. Give the 3PL bonus points if it can personalize the handling instructions to each shipper.

Make sure the 3PL understands the rules in all the geographic areas where you ship, since local regulations can vary.

3. Certified Processes

FSMA requires specific documentation. The 3PL you choose should already be aware of the rules and have processes in place for compliance. It should have taken the initiative to have its processes audited for compliance. After all, compliance with regulations is part of the service it provides for you.

Ask the provider to show you its method for conveying handling instructions to carriers, and how it ensures that carriers follow the instructions. The burden of proof for cold-chain integrity or HACCP compliance falls to you, so don’t entrust your business to a 3PL that doesn’t understand it.

4. Track and Trace, Lot and Expiration Controls

Recalls happen. Your 3PL should have technology in place to provide visibility throughout the supply chain, including the ability to track and trace from end to end. Ask to see its picking process, and how it ensures first-in-first-out (FIFO) lot picking so you minimize spoilage. How does it handle expired or soon-to-expire lots? Can it segregate the goods so it doesn’t actually ship them? How does it notify you of upcoming expirations? Proactive alerting is the ideal mechanism.

5. Size and Locations

Once the 3PL you are considering has proven it understands how to handle food products safely and legally, the next step is to ensure it can provide the coverage you require. It should have offices in or near your distribution points. Ask to see the 3PL’s customer list. You don’t want to be much larger than its current largest customer because it may not be equipped to deal with your volumes. You also don’t want to be among its smallest shippers, because you may not get the attention you deserve.

Make sure the provider is fiscally sound, especially if you are entering this relationship for the long term.

6. Technology

Technology is fast becoming the biggest differentiator for a 3PL. Ask about the systems it uses for collaboration and visibility. Does it have automated picking capabilities? Are your business systems easily compatible if you want to integrate, or does it provide a shipper portal for 24/7 access? What are its future technology plans? A good 3PL should be excited to talk about its technology because it would know it’s a key differentiator. If the provider is reluctant to talk about it or lagging in the technology arena, it will not be a good long-term partner.

Your business depends on a great 3PL, and your customer’s health and safety may rely on it as well. Take the time to thoroughly vet any 3PL you are considering before signing on the dotted line.

Bryan Armentrout, Food Leadership Group
FST Soapbox

Tips on Handling an FDA Audit

By Bryan Armentrout
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Bryan Armentrout, Food Leadership Group

Here’s a typical scenario.

You are the QA Manager for a dairy manufacturing facility in the Midwest. It’s been a long week and you decide to come in a little earlier than normal to catch up on paperwork. You find out when you arrive that product is on hold because the filling line is down. Maintenance is all over the machines, and orders are piling up; the paperwork will have to wait. You head out to the line to see what you can do to help.

This only happens when the plant manager is on vacation, you think to yourself.

As you walk out to the floor, your ears perk up as you hear your name paged over the intercom. The receptionist needs you in the front office—immediately.

What now?

You can’t think of anyone who is scheduled to visit today. You heart sinks a little. You don’t like surprises and this could be a bad one.

You come around the corner to the lobby to see exactly who you were hoping you wouldn’t see: An FDA investigator.

“My name is Investigator Brown,” he says as he flashes a badge. “We’ve had an allegation of an illness from your product. I am here to look into it.”

You smile politely and nod. He does not smile. You motion for him to follow you to a conference room.

Your day just got a whole lot longer.

How will this go?

The answer to that question is, in many ways, up to you.

FDA investigators are people and they take their job as seriously as you do. They are there because they need answers. Their boss expects answers. If people are getting sick, they need to find out quickly and take action. If this is truly the case, you need to know as well. So does your boss. No one wants people to get sick.

The absolute wrong thing to do in this situation is to not have a plan. You need to know how to handle a regulatory inspection. You need a plan to prevent a misunderstanding or create a situation where something minor gets blown out of proportion.

This is not the time to play it by ear. You need training and you need a plan.

An important point to remember is that your product may not have caused the illness. People often assume the last food they ate is the one that made them sick. In reality, incubation times may take significantly longer for symptoms to manifest. Samples of the product in question are rarely available to test. Dosage, health of the person, and other factors also come into play. You need to work with facts and not supposition—as does the FDA.

Tips for an FDA Inspection

  1. You are guilty until proven innocent
  2. You are not alone
  3. You are the company spokesperson
  4. Take lots of notes
  5. Seek first to understand, then to be understood
  6. Answer the question being asked
  7. Know what is in scope and what is out of scope
  8. Don’t sign or initial anything

1. You are guilty until proven innocent

In general, you can assume that FDA thinks you are at fault; that is why they are there. You will have a hole to dig yourself out of before you can convince them otherwise. Don’t let that rattle you, they are only doing their job, and your job is to show them all the great food safety programs you have in place to prevent what they are concerned about. Keep this in mind as you go through the visit. If you are doing a good job, you should see their demeanor soften as they gain confidence in what you do.

2. You are not alone

Don’t be a hero, you need a team to help you in this situation. You need the people in the plant and you need people at corporate ready to back you up. You most likely also need access to outside counsel that specializes in food regulations. Your role in the room is to facilitate and work with FDA to get them what they need. You and FDA are on the same side of the table in this respect. Both of you are working to find out if the illness is real.

If you are not sure of an answer, say so! Call corporate QA and your legal counsel and discuss it. Find out what the answer is from someone who does know. If you still don’t have an answer, it’s better to admit it than to make something up. Tell them when they can expect an answer, even if it may be after the audit concludes. Never make stuff up.

3. You are the company spokesperson

The company should have only one voice (most likely, you) responding during the inspection. This avoids confusion and keeps you in control over the message being delivered. Other agencies, such as OSHA, have the right under the law to interview employees during an investigation. It is not that clear cut with FDA. Make sure you explain to FDA that you are the designated spokesperson for this inspection and that all questions need to be routed through you. The personnel in the facility need to understand this as well and defer to you if FDA questions them. If the question is out of the ordinary, it may need to be in writing. When on the floor, never leave the investigator alone, accompany them at all times (don’t go crazy, they can use the bathroom by themselves).

4. Take lots of notes

Have someone who can tag along with you to take written notes of the visit. Train them on what you expect. Time stamp the notes and use a stream of consciousness approach. Write down everything, more notes are preferred. You may need them in the future. Never take the notes yourself, you are going to be too busy to do that. Mark the notes confidential and do not give a copy to FDA. Also, make sure that you have a clear and explicit ‘no photography’ policy in place. Train your people and enforce it. FDA may want to take pictures and they will tell you that they have the right to do so. That is open to debate and the issue has yet to be resolved in court. In the meantime, your policy is clear, so insist that they do not take pictures. This is your plant and your proprietary process; even with the best care, your competitors might find out more than they should about what you do.

5. Seek First to Understand, then to be Understood

This rule applies everywhere in life, and especially during an FDA inspection. Gather all the information you can. Are they going to take samples? If so, you need to prepare for that. Ask for the purpose of the visit and any supporting information you can get. Seek to first meet the needs to the investigator and to understand the exact context of the inquiry. The better you understand the purpose, the easier the day will be. Just like the investigator, you have a boss. You have limits to what you can and cannot do. Make sure the FDA understands that you are the representative, but the answer may need to come from other sources. Company policies are not written by you and cannot be altered. You are both on the same side of the table and rules need to be followed. They will understand and respect that.

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Erika Miller
FST Soapbox

When Worlds Collide

By Erika Miller
2 Comments
Erika Miller

The Foreign Supplier Verification requirements of FSMA have perhaps been less well advertised than those of the Preventive Controls rules, but the compliance dates are fast approaching nevertheless. On May 30, 2017, a new field will appear in Ace, the software system wherein importers declare their imports and, in so doing, fulfill the requirements of many different U.S. regulations. This seemingly innocuous event will have serious and wide-reaching implications for all entities involved in the importation of food intended for consumption in the United States, but perhaps no one will be more affected than brokers and distributors, for they have long relied on the protection of their sources to ensure a share of the profits on their imports.

Exchange knowledge about managing your supply chain at the Best Practices in Food Safety Supply Chain conference | June 5–6, 2017 | LEARN MORE

Brokers and distributors often provide an important service by taking care of the legal requirements to bring a product into the country, and by purchasing large quantities of product that can then be broken down into more manageable quantities for their customers. Nowadays, information that was used to be transmitted to Customs and Border Protection (CBP) on paper forms is entered in Ace, which is a one-stop-shop software system that aggregates data on all imports. This data can then be accessed by several government agencies, including the FDA. Anyone wishing to bring food into the United States for consumption on our shores will be required to declare a Foreign Supplier Verification Program (FSVP) Importer for the food, and the names entered as FSVP Importers will then form a database from which the FDA will work to ensure enforcement of this program.

This FSVP Importer may or may not be the same as the Importer of Record (IOR). Large companies are already re-writing their import contracts to include this requirement, for it’s quite clear already that communication of expectations will be vital to the success of this program. The FDA recognizes that it is possible that unscrupulous parties may enter the name of a party as the FSVP Importer who does not realize their name has been entered; however, the main recourse for the injured party is to better communicate with their supply chain to ensure the issue does not arise again.

Although these technicalities are important to understand, it is perhaps even more interesting to consider the implications of all the FSMA requirements surrounding this rule. For example, FDA’s requirements for records are very clear, and each record must include the name and address of the facility at which it was created, in addition to other information. The rules of FSMA are also quite clear in stating that brokers or distributors cannot provide the necessary food safety paperwork on their own; rather, this documentation must come from the grower, manufacturer, processor—for a true farm-to-fork implementation, in keeping with the spirit of the rule.

What does this mean for the broker who sells to a large company that is perfectly capable of purchasing the large quantities required to “go direct”? Will they be cut out of their livelihoods by being forced to give this information to their customers? This is a question that has been raised in all the FSVP Importer classes held to date, and in reading the rule, it appears clear that the broker is expected to disclose their source. How else is it possible for them to follow the law, and assure their customer that the food was produced with the same level of food safety as if it were made here in the United States?

Foreign Supplier Verification, TraceGains A Comprehensive Guide to the Who, What & How to FSMA’s FSVP Rule

Have confusion regarding some of the specifics to FSMA’s Foreign Supplier Verification Program rule? You’re not alone… Are you the importer? What if you’re a broker? What are the actual contents of a verification program? This comprehensive guide can help answer some of these lingering questions, and will provide you with a couple real examples of FSVP in action.

This is a particularly interesting conundrum because at its heart, this is an issue of information exchange between private companies. Although the FDA does expect that some entity will keep the records to satisfy the requirements of the FSVP, they will not expect this paperwork to be transmitted to any government agency prior to approval of a load for import. Rather, the FDA will send electronic records requests to the entities declared as FSVP Importers later, wherein they will ask for the records related to previous shipments. Should the FSVP Importer declared at import not produce the required documentation at the time of this request, enforcement activities are expected to result (eventually, once the rule has gone into effect and regulation has begun).

It stands to reason that some entities may continue to operate in a fool’s paradise for some length of time, thinking nothing has really changed. This is incredibly dangerous for the business, its reputation and indeed, for the consumer. Times are obviously changing across the globe, and the FDA is doing its best to keep up with the demands of an increasingly complex global society. The broker who enters his own name without understanding the implications of what that means may find himself on the receiving end of a number of records requests from the FDA, with no records on hand with which to fulfill them. This is not an enviable position, and will likely result in an in-person visit from an investigator if the food imported is considered high-risk.

There are, of course, many brokers and distributors who are proactive and concerned about food safety. These are the companies that are sending multiple individuals to FSVP training to stay informed about the changing face of import regulations. Many of these brokers and distributors already gather paperwork such as third-party audit reports and letters of guarantee from their suppliers, but they do not transmit this information to their customers. Should these proactive companies be essentially punished for following the letter of the law? Even if a purchasing department has a warm personal relationship with their broker or distributor, if the C-suite sees an opportunity to save a substantial sum on their commodity of choice while increasing transparency in the supply chain, certainly those decisions will be made without regard for hurt feelings.

What about redaction? Can the brokers or distributors redact the sensitive information from the documents, and transmit them in that way? Perhaps, but after consultation with a brilliant and experienced legal mind, redaction may not be the panacea it first appears. For example, redaction of documents is a boring and redundant task, frequently relegated to the intern or other low-paid office worker due to its repetitive nature. These workers may perform the redaction lackadaisically, or use CTRL-F to find all appearances of the information to be redacted. In doing this, they often miss important information that appears in an image or is misspelled. Additionally, anyone who has spent much time in the food industry understands that this is a small world, and it is often easy to recognize a document simply from the style in which a particular company presents all its documentation. Clues such as colors, partial logos and incomplete redaction can lead to a shrewd individual deducing the original author of the documents quite easily.

Although there are no answers to be had at this juncture, especially considering that the compliance date for these requirements has not yet passed, it is important to think about all these implications, along with many others that are being brought to the forefront through the Importer workshops approved by the Food Safety Preventive Controls Alliance. The FDA readily admits they are learning right alongside industry, and they have every intention of continuing to educate while they regulate. If these issues cannot be hammered out between industry representatives and the FDA directly, it stands to reason the issue will eventually be brought before the courts, where the demands of capitalism will be weighed against those of regulation for food safety. Is there a legal precedent for this situation? If you know of one (or several), please leave the information in the comments below to continue the discussion.

Audit

Best Practices for ISO 17025 Accreditation: Preparing for Your Food Laboratory Audit (Part II)

By Joy Dell’Aringa
2 Comments
Audit

In Part I of this article, we explored the considerations a laboratory should initially evaluate when pursuing accreditation, as well as guidance from leading industry experts on how to prepare for an ISO 17025 audit. Here we will review what comes after the on-site assessment and provide practical user-based advice for preparing a response, common areas of non-conformance, and future changes to the ISO 17025 Standard.

The Response

Once the assessor has completed the audit, they will typically hold a closing meeting on-site where they present their findings, also referred to as deficiencies or non-conformances. For each finding they will document a specific reference to the standard as evidence and provide opportunity for questions and discussion. Most assessors will be open and conversational during this final portion of the assessment; laboratories are well suited to take advantage of this time. Some assessors will even brainstorm possible responses and corrective actions while onsite; this is valuable insight for the laboratories quality team and can help them get a jump on the response.

Depending on the accrediting body, the laboratory will have a certain amount of time to respond to the findings, usually 30–60 days. The anatomy of a well-assembled response will include a full corrective action report, complete with root cause analysis. Often, the assessor will also request supporting documents and records to show the effectiveness of a corrective action. Most laboratories will have forms to help guide users through the corrective action and root cause process. It is important to have a systematic approach to ensure your corrective action is thorough and balanced.

Determining root cause is a critical part of this exercise. Erin Crowley, CSO of Q Laboratories shares their approach. “We use a variety of root cause analysis techniques, but have found for our operation the principle of the ‘5 Why’s’ is very effective,” she says. “Don’t simply answer the singular deficiency. Accrediting bodies will want to know that you have addressed all variables that might be associated with a finding. For example, if a specific incubator was out of range on a specific date, don’t just indicate that someone fixed it and move on. Assess how they addressed the issue, any impact on data, what they did to react to it, and how they are putting systems in place to prevent it from happening in the future on any other incubator. You have to show the full process.”

Implementing procedures as an outcome of a corrective action can also bring challenges to an operation. As a national multi-site reference lab, Eurofins Quality Manager Peter Dragasakis must work with other departments and locations to deploy new or changed systems for compliance. “Sometimes the most challenging part of the entire audit process is coordinating internal stakeholders across other departments such as IT or complimentary analytical departments,” he says. “Coordinating a response in a timely manner takes full organizational cooperation and support.” Communication throughout the quality and operational arms of an organization is critical to a successful response. Often, accrediting bodies and laboratories may shuttle a response back and forth a few times before everyone is satisfied with the outcome.

Common Areas of Non-Conformance: Pro-Tips

While all areas of the standard are important to a conformant operation, there are a few key areas that are frequently the focus of assessments and often bare the most findings.

Measurement Uncertainty. Depending on the laboratories Field of Testing (FOT), Measurement Uncertainty (MU) can be captured in a multitude of ways. The process aims to systematically and quantifiably capture variability in a process. For chemical analysis this is typically well defined and straightforward. For microbiological analysis the approach is more challenging. A2LA’s General Manager, Accreditation Services, Adam Gouker says the reason many labs find themselves deficient in this area is “they don’t consider all of the contributors that impact the measurement, or they don’t know where to begin or what they need to do.” Fortunately, A2LA offers categorical guidance in documents P103a and P103b (for the life sciences laboratories, two of the of many guidance documents aimed at helping laboratories devise systems and protocols for conformance.

Traceability. There are several requirements in the ISO 17025 standard around traceability. In terms of calibration conformance, which accrediting bodies seem to have emphasized in the last few years, Dragasakis offers this tip: “When requesting [calibration] services from a vendor, make sure you’re requesting 17025 accredited service. You must specify this, as several levels of service may be available, and “NIST Traceable” certificates are usually no longer sufficient.” He also advises that calibration certificates be scrutinized for all elements of compliance closely. “Some companies will simply state that it is ‘ISO 17025 compliant’, [and] this does not mean it is necessarily certified. Look for a specific reference to the accrediting body and the accreditation certificate number. Buyer beware, there is often a price difference between the different levels of calibration. Always practice due diligence when evaluating your calibration vendor and their services, and contact the calibration service if you have any questions.”

Validation vs. Verification. One of the more nuanced areas of the standard lies in determining when a test requires validation, verification, or an extension, specifically when there is a modification to a method or a sample type not previously validated by an internationally recognized organization (AOAC, AFNOR, etc.). Certified Laboratories Director Benjamin Howard reminds us, “think of validation and verification as existing on a spectrum. The more you stray away from an existing validation, the more validation work is required by the analyzing laboratory.” For example, analyzing Swiss cheese for Salmonella by a method that has already been validated for soft queso cheese may require only minimal verification or matrix extension. However, a laboratory that is altering a validated incubation time or temperature would require a much more robust and rigid validation process. Howard cautions, “Accredited laboratories must be transparent about modifications, not only on their scope of accreditation but on their reports [or CofA’s] as well. Under FSMA, companies are now accountable to the data that their laboratories generate. If you see a “modification” note on your report, perform due diligence and discuss this with your laboratory. Ensure a proper validation of the modification was performed. “Additionally, the ISO 17025 standard and accrediting bodies do not mandate how a validation or verification should be done. Laboratories should have a standalone SOP that outlines these procedures using scientifically supported justification for their approach.

CAPA / Root Cause. A good corrective action / preventive action (CAPA) and root cause (RC) analysis program is at the heart of every sound quality system. “Corrective and preventive action (CAPA) processes can either add value or steal time away from the organization according the quality of the root cause analysis,” says Vanessa Cook, quality systems manager at Tyson Foods Safety & Laboratory Services. “CAPA might be the single greatest influence on an organization’s ability to continuously improve and adapt to change if diligence is given to this activity.” Investing in resources such as ongoing training in CAPA/RC programs and techniques are key components to ensuring a robust and effective CAPA / RC program.

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