Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

Five Things to Look for in a Trading Partner

By Shawn K. Stevens
No Comments
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
No Comments
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.

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.

Sean Crossey, arc-net
FST Soapbox

5 Problems Facing the Global Food Supply Chain

By Sean Crossey
No Comments
Sean Crossey, arc-net

The food we eat is a lot less secure than we would like to imagine. According to PricewaterhouseCoopers, food fraud is estimated to be a $40 billion a year problem, with instances of fraud becoming worryingly frequent—from wood shavings discovered in our parmesan to the 2013 horsemeat scandal in the UK.1-3 Not only do these incidents damage the faith consumers have in their food, but as seen in the 2009 salmonella peanut butter outbreak, which resulted in the death of 9 Americans and sickening of 714, they can have fatal consequences.4 Indeed, the World Health Organization estimates that nearly 1 in 10 people become ill every year from eating contaminated food.5

While it may be uncomfortable to imagine our food supply can be susceptible to such high profile attacks, what is more unsettling is that our food supply chain has grown so complex that it has become almost impossible for food producers to guarantee the provenance of their products—meaning consumers can never entirely trust in the food they eat. In this article I will identify five main issues the global food supply chain faces, and what steps can be taken to address them.

Exchange knowledge about managing your supply chain at the Best Practices in Food Safety Supply Chain conference | June 5–6, 2017 | LEARN MORE1. Consumer demand for traceability

Traceability is no longer a request from consumers, but a demand, and one that is only growing stronger. A recent transparency survey found that consumers want to see everything from a complete ingredient breakdown to sourcing information, with 94% of respondents saying they are likely to be more loyal to a brand that offers complete transparency.6 While a new study discovered that more than half of Canadians are concerned about food fraud.7

If we take seafood products as an example, almost half (46%) of respondents to an independent research survey conducted by the Marine Stewardship Council (MSC) agreed that they trust brands that use ecolabels (a form of third-party certification) more than those that do not.8 The survey also found that 66% of respondents felt that traceability of the product was the primary factor determining seafood purchasing decisions.

This kind of consumer driven, high-quality information opens up a world of possibilities for companies that recognize the significance of its demand. Brand protection, demand forecasting and consumer loyalty all becomes possible for early adapters who show themselves to be taking practical steps to guarantee the authenticity of their products.

2. Lack of communication between actors

One of the biggest challenges preventing full traceability of our food is the fragmented nature of the supply chain. For even the most seemingly simple of food items there can be a huge number of actors involved that are spread around the globe with little to no knowledge of one another’s actions.

For instance, to trace your hamburger from farm to fork may involve tracing your lettuce back to the farm in which it was grown (but not what happens to it before it reaches your supermarkets shelves), tracing the beef back to the cattle (with no guarantee, as seen with the horsemeat scandal, that the end product is 100% beef) and any number of logistical barriers.

It is vital then that stakeholders within the chain prioritize communication with their suppliers, either through the implementation of traceability solutions, or the commitment to engage only with suppliers they know they can trust. Not only is this beneficial to the end consumer, but to the food producers themselves, allowing them to ensure that their organizational reputation remains solely their responsibility and not left in the hands of unknown and uncontrollable third parties.

3. Influence of organized crime

When one thinks of the Mafia, it’s rare that olive oil is the first thing that comes to mind. Currently, however, it is the fraudulent manufacture of this and many other Italian exports (cheese, wine, etc.) that is fueling organized crime and ending up on our shelves.9

High-scale food fraud is not a naturally occurring phenomenon but rather exists as a result of highly organized criminal activity. In his 2014 UK government report, Professor Chris Elliot notes that “food fraud becomes food crime when it no longer involves random acts by “rogues” within the food industry, but becomes an organized activity by groups that knowingly set out to deceive and or injure, those purchasing food”.10

This is not just a problem for Italy; counterfeit food and drink occurs on a massive scale throughout the whole of Europe. A joint initiative by EUROPOL and INTERPOL last year led to the largest ever seizure of fake and adulterated projects. This project, known as OPSON V resulted in 11,000 tons and 1,440,000 liters of hazardous fake food and drink seized across 57 countries.11

In order to combat the growing threat organized crime has on our food supply, it is vital that governments devote resources to organizations with the sole responsibility of identifying food crime. In response to the horsemeat scandal, the UK government launched its National Food Crime Unit within the Food Standards Agency in London, while the FDA has a special focus on food defense.

The establishment of these organizations is important, as police forces traditionally have struggled to combat food fraud, either through a lack of time, resources, or simply understanding of the complexities of how fraud affects the supply chain. The creation of specialist taskforces not only legitimizes the fight against food fraud, but allows for easier intelligence share.

4. Lack of transparency throughout the supply chain

In her work on trust for the digital age, Racheal Botsman tells us that trust has evolved from an institutional based system to a distributed system. Nowhere has this more potential than with our food supply.

In such a complex system it becomes necessary to consider how the food industry can begin to move away from traditional systems of centralized trust. As Botsman points out, “institutional trust is not designed for the digital age”, the emergence of new technologies, most notably the blockchain, highlights the potential to introduce more trust in our food.12

Originally the technology underpinning Bitcoin, the blockchain has wide ranging applications beyond the world of FinTech. Blockchain is a transformative tool in the fight against food fraud, allowing an open and transparent ledger of our food products journey. This allows unalterable trust to be introduced into an untrustworthy system, ensuring every actor in the chain records and shares their interactions with our food.

This represents a huge opportunity for those companies who see the advantage of early adoption of blockchain infused traceability systems. Indeed by 2022, Gartner estimates an innovative business built on a blockchain will be worth $10 billion.13

5. Need for strong legislation

Steps have already been made in legislation to allow for earlier prevention of food safety incidents occurring, such as FSMA. While it is important that lawmakers are proactive in their response, the focus has primarily been on food safety, and there is still a difficulty in treating food fraud as its own separate entity.

Legislation regarding food labelling could also be more stringent, especially in Europe. At present only olive oil, fish (unless it’s canned or prepared), beef (fresh, chilled, frozen or minced), fresh or frozen poultry of non-EU origin, wine, most fresh fruit and vegetables, honey and eggs are required to be labelled. This means that origin information is largely missing on foods such as meat products (e.g., ham and sausages), yogurts and cheese, kitchen staples (e.g., oil, flour, sugar and pasta), biscuits and confectionery, or ready-meals.

Tighter legislation, leading to significant punitive measures taken against actors found to be committing fraud, would be a vital catalyst in ensuring that food in our supply chain is as secure as possible.

Conclusion

The growth of the global food supply chain may bring with it complexity and challenges, but also great opportunities. If actors can interject their processes with the kind of joined up thinking outlined above, with the help of technological tools that are becoming more and more accessible, the benefits will be significant, not just for them, but for all of us.

Resources

  1. PWC. (2016). Fighting $40bn food fraud to protect food supply [Press Release]. Retrieved from http://press.pwc.com/News-releases/fighting–40bn-food-fraud-to-protect-food-supply/s/44fd6210-10f7-46c7-8431-e55983286e22
  2. Mulvany, L. (February 16, 2016). The Parmesan Cheese You Sprinkle on Your Penne Could Be Wood. Retrieved from https://www.bloomberg.com/news/articles/2016-02-16/the-parmesan-cheese-you-sprinkle-on-your-penne-could-be-wood
  3. Grierson, J. (August 26, 2016). Three men charged over UK horsemeat scandal. Retrieved from https://www.theguardian.com/uk-news/2016/aug/26/three-men-charged-over-uk-horsemeat-scandal
  4. Andrews, J. (April 16, 2016). 2009 Peanut Butter Outbreak: Three Years On, Still No Resolution for Some. Retrieved from http://www.foodsafetynews.com/2012/04/2009-peanut-butter-outbreak-three-years-on-still-no-resolution-for-some/#.WD7tE6KLTpJ
  5. World Health Organization. (2015). WHO’s first ever global estimates of foodborne diseases find children under 5 account for almost one third of deaths [Press Release] Retrieved from http://www.who.int/mediacentre/news/releases/2015/foodborne-disease-estimates/en/
  6. Label Insight (2016). The 2016 Label Insight Transparency ROI Study. Retrieved from https://www.labelinsight.com/hubf /2016_Transparency_ROI_Study_Label_Insight.pdf?t=1486676060862
  7. Sagan, A. (February 21, 2017). Study finds 63 per cent of Canadians are concerned about food fraud. Retrieved from http://www.theglobeandmail.com/news/national/study-finds-63-per-cent-of-canadians-are-concerned-about-food-fraud/article34094664/
  8. MSC (2014). MSC Consumer Survey 2014. Retrieved from https://www.msc.org/newsroom/news/new-research-shows-increasing-appetite-for-sustainable-seafood
    Bacchi, U. (February 21, 2017). Italian police break mafia ring exporting fake olive oil to U.S. Retrieved from http://www.reuters.com/article/us-italy-crime-food-idUSKBN1602BD
  9. HM Government (2015) Elliot Review into Integrity and Assurance of Food Supply Networks. Retrieved from https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/350726/elliot-review-final-report-july2014.pdf
    EUROPOL (2016) largest ever seizures of fake food and drink in INTERPOL-EUROPOL operation [Press Release]. Retrieved from https://www.europol.europa.eu/newsroom/news/largest-ever-seizures-of-fake-food-and-drink-in-interpol-europol-operation
  10. Botsman, R. (October 20, 2015). The Changing Rules of Trust in the Digital Age. Retrieved from https://hbr.org/2015/10/the-changing-rules-of-trust-in-the-digital-age
  11. Panetta, K. (October 18, 2016) Gartner’s Top 10 Strategic Technology Trends for 2017. Retrieved from http://linkis.com/www.econotimes.com/Zk8mh
Tim Daniels, Autoscribe Informatics
In the Food Lab

Using LIMS to Get In Shape for FDA’s Visit

By Tim Daniels
No Comments
Tim Daniels, Autoscribe Informatics

FSMA is a major reform of the U.S. food safety laws. It shifts the emphasis for food safety to preventing contamination during manufacture instead of just responding to it. As part of the implementation process, the FDA will enforce these new rules during routine random inspections at food manufacturing sites. With such a significant change in emphasis, Shawn K. Stevens of Food Industry Counsel LLC, released an FDA Inspection Checklist. The checklist is designed to help food and beverage manufacturers to prepare for an agency inspection and to ensure they have the required controls and checks in place. Before we look in more detail at the checklist, it is worth reviewing some of the underlying requirements.

Some Basic Requirements

One of the fundamental requirements of FSMA is the establishment of an environmental monitoring program at each facility. It defines the testing protocols for appropriate microorganisms and verifies that the preventative measures undertaken are effective. Clear procedures and systems are required to identify the test microorganisms most suited to the risks in their systems. They need procedures to identify the locations from which samples will be collected and the number of sites to be sampled, since the number and location must be adequate to determine whether the preventative controls are effective. They also need to identify the timing and frequency for collecting and testing samples. The tests to be conducted must be specified, including the analytical methods used and the corrective action procedures in the event that testing detects an environmental pathogen or an indicating organism. Just as importantly, all of the data associated with this testing program needs to both be recorded and accessible for audit purposes.

Acquiring and Managing Environmental Monitoring Data

Any environmental monitoring program will come at a cost to the food manufacturer. While the program itself will need to be set up by experts in the field, much of the implementation can be carried out by lesser-qualified technicians. So a key aspect is having the tools to implement a program where the most effective use is made of each resource available, as this keeps costs down. In principle, one such tool is a Laboratory Information Management System (LIMS).  The use of a LIMS is commonplace in QA Labs to record and monitor laboratory samples, tests and results in order to simplify and automate processes and procedures. There is a variety of ways in which a LIMS could facilitate the environmental monitoring process to enable best practice even by non-specialist staff. For example, analysis can be simplified if each set of test results can be automatically linked to respective sampling points in the facility. Out-of-specification test results could be linked to corrective and preventive actions (CAPA). Test failures at a particular sampling point could be used to trigger more frequent testing at that point according to pre-set criteria.

  • The data management capabilities within a LIMS make it possible to:
  • Implement data management strategies that increase security and availability of data
  • Eliminate manual assembly of data for analysis and audit
  • Make data more useful with easy retrieval/visibility

Perhaps most importantly, a properly configured LIMS can provide a suitable framework for set-up and adjustment by the environmental monitoring expert, while reducing the expertise required to operate it on a daily basis.

Laboratory Information Management Systems
The Matrix Gemini Environmental monitoring solution is an example of an information management system that uses the capabilities of a LIMS to record and monitor laboratory samples, tests and results to simplify and automate environmental monitoring in QA Labs. Image courtesy of Autoscribe Informatics

FDA Inspection Checklist

This comprehensive document highlights the steps that companies need to take to prepare for the inspection process, navigate the inspection itself and respond to any criticisms arising from the inspection.

There are three main areas in the checklist where a LIMS could help satisfy FSMA requirements:

  1. Finalizing written food safety systems and making sure certain employees know the plans. LIMS provides the framework to set up documented food safety sampling requirements and track microbial test results over time. This facilitates recall and more detailed investigation should a sample fail.
  2. Well organized and maintained data, and ease of records access. LIMS should be capable of date and time stamping every entry and since it will contain all the test data over time, this can be easily recalled should the need arise. Typically a standard operating procedure would be developed, which will increase testing and start “out-of-specification” actions if abnormal microbial contamination is detected. LIMS can provide a full audit trail for all test data and produce reports showing result trends over time, highlighting variance and peaks in data.
  3. Proper documentation of corrective actions. In the event of failures, investigators will want to focus on the particular sample points and the “out-of-specification” actions that were initiated to investigate and resolve these failures. Typically three months of data is requested around these sample points, although up to two years’ worth of data could be requested. LIMS should allow data to be instantly pulled from the database as a report for further investigation.

FDA investigators will be most interested in what happens in the event of a failure and what learning gets incorporated into your regular regime. What happens when an out-of-specification result is obtained is the crux of preventive testing regimes. Actions might include changing sanitation methods, increasing test frequency or locations in areas of concern, segregating traffic patterns, re-training staff and so forth. Some of these actions, such as increasing test frequency, can be automated. All actions must be clearly documented, which can be done by adding appropriate records directly into the LIMS. This captures the actions that each quality improvement cycle needs in order to discover the likely root cause of any problems and how they may be avoided in the future.

All corrective actions should identify the root cause of the deviation, actions taken to prevent recurrence and, if product safety is not affected, a written conclusion (supported by factual and scientific data) that the deviation “does not create an immediate food safety issue.”

The emphasis should always be on preventive actions to remove potential points of failure before issues get into the final delivered products causing stock loss and costly recalls.

Configuring a LIMS for Environmental Monitoring

While most LIMS in principle provide the capability to handle the requirements of environmental monitoring, the system will need to be configured to do so, and this may not be a trivial exercise. The software will need to be configured to represent user requirements in terms of workflows, screen designs, menu designs, terminology, numbering schemes, report designs and much more. For many LIMS, full configuration for specific applications requires custom coding, which will require re-validation.

Once configured, LIMS can offer a practical way for food and beverage companies to document their sanitation/safety programs and instantly show written evidence of both testing and corrective actions when the FDA comes knocking.

Sanjay Singh, Eurofins
Food Genomics

How is DNA Sequenced?

By Sanjay K. Singh, Douglas Marshall, Ph.D., Gregory Siragusa, Ph.D.
No Comments
Sanjay Singh, Eurofins

Here is a prediction. Within the next year or years, at some time in your daily work life as a food safety professional you will be called upon to either use genomic tools or to understand and relay information based on genomic tools for making important decisions about food safety and quality. Molecular biologists love to use what often seems like a foreign or secret language. Rest assured dear reader, these are mostly just vernacular and are easily understood once you get comfortable with a bit of the vocabulary. In this the fourth installment of our column we progress to give you another tool for your food genomics tool kit. We have called upon a colleague and sequencing expert, Dr. Sanjay Singh, to be a guest co-author for this topic on sequencing and guide us through the genomics language barrier.

The first report of the annotated (labeled) sequence of the human genome occurred in 2003, 50 years after the discovery of the structure of DNA. In this genome document all the genetic information required to create and sustain a human being was provided. The discovery of the structure of DNA has provided a foundation for a deeper understanding of all life forms, with DNA as a core molecule of genetic information. Of course that includes our food and our tiny friends of the microbial world. Further molecular technological advances in the fields of agriculture, food science, forensics, epidemiology, comparative genomics, medicine, diagnostics and therapeutics are providing stunning examples of the power of genomics in our daily lives.  We are only now beginning to harvest the fruits of sequencing and using that knowledge routinely in our respective professions.

In our first column we wrote, “DNA sequencing can be used to determine the names, types, and proportions of microorganisms, the component species in a food sample, and track foodborne diseases agents.” In this month’s column, we present a basic guide to how DNA sequencing chemistry works.

Image courtesy of US Human Genome Project Knowledge base
Image courtesy of US Human Genome Project Knowledge base

DNA sequencing is the process of determining the precise order of four nucleotide bases, adenine or A, cytosine or C, guanine or G, and thymine or T in a DNA molecule. By knowing the linear sequence of A, C, G, and T in a DNA molecule, the genetic information carried in that particular DNA molecule can be determined.

DNA sequencing happened from the intersections of different fields including biology, chemistry, mathematics, and physics.1,2 The critical breakthrough was provided in 1953 by James Watson, Francis Crick, Maurice Wlkins and Rosalind Franklin when they resolved the now familiar double helix structure of DNA.3 Each helical strand was a polynucleotide, which consists of repeating monomeric units called nucleotides. A nucleotide consists of a sugar (deoxyribose), a phosphate moiety, and one of the four nitrogenous bases—the aforementioned A, C, G, and T. In the double helix, the strands run opposite to each other, commonly referred as anti-parallel. Repeating units of base-pairs (bp), where A always pairs with T and C always pairs with G, are arranged within the double helix so that they are slightly offset from each other like steps in a winding staircase. On a piece of paper, the double helix is often represented by scientists as a flat ladder-like structure, where the base pairs (bp) form the rungs of the ladder while the sugar-phosphate backbone form the antiparallel rails (see Figure 1).

DNA Double Helix
Artistic representation of DNA Double Helix. Source: Eurofins

The two ends of each polynucleotide strand are called 5′ or 3′-end, a nomenclature that represents the chemical structure of the deoxyribose sugar at that terminus. The lengths of a single- or double-stranded DNA are often measured in bases (b) or bases pairs (bp), respectively. The two polynucleotide strands can be readily unzipped by heating, and on cooling, the initial double-helix structure is re-formed or re-annealed. The ability to rezip the initial ladder-like structure can be attributed to the phenomenon of base pairing, which merits repetition—the base A always pairs with T and the base G always with C. This rather innocuous phenomenon of base pairing is the basis for the mechanism by which DNA is copied when cells divide and is also the theoretical basis on which most traditional and modern DNA sequencing methodologies have been developed.

Other biological advancements also paved the way towards the development of sequencing technologies. Prominent amongst these were the discovery of enzymes that allowed a scientist to manipulate the DNA. For example, restriction enzymes that recognize and cleave DNA at specific short nucleotide sequences can be used to fragment a long duplex strand of DNA.4 The DNA polymerase enzyme, in the presence of the deoxyribose nucleotide triphosphates (dNTPs: Chemically reactive forms of the nucleotide monomers), can use a single DNA strand to fill in the complementary bases and extend a shorter rail strand (primer extension) of a partial DNA ladder.5 A critical part of the primer extension is the ‘primer’, which are short single-stranded DNA pieces (15 to 30 bases long) that are complementary to a segment of the target DNA. These primers are made using automated high-throughput synthesizer machines. Today, such primers can be rapidly manufactured and delivered on the following day. When the primer and the target DNA are combined through a process called annealing (heat and then cool), they form a structure that shows a ladder-like head and a long single-stranded tail. In 1983, Kary Mullis developed an enzyme-based process called Polymerase Chain Reaction (PCR). Using this protocol, one can pick a single copy of DNA and amplify the same sequence an enormous number of times. One can think of PCR as molecular photocopier in which a single piece of DNA is amplified up to approximately 30 billion copies!

The other critical event that changed the course of DNA sequencing efforts was the publication of the ‘dideoxy chain termination’ method by Dr. Frederick Sanger in December 1977.6 This marked the beginning of the first generation of DNA sequencing techniques. Most next-generation sequencing methods are refinements of the chain termination, or “Sanger method” of sequencing.

Frederick Sanger chemically modified each base so that when it was incorporated into a growing DNA chain, the chain was forcibly terminated. By setting up a primer extension reaction where in one of the chemically modified ‘inactive’ base in smaller quantity is mixed with four active bases, Sanger obtained a series of DNA strands, which when separated based on their size indicated the positions of that particular base in the DNA sequence. By analyzing the results from four such reactions run in parallel, each containing a different ‘inactive’ base, Sanger could piece together the complete sequence of the DNA. Subsequent modifications to the method allowed for the determination of the sequence using dye-labeled termination bases in a single reaction. Since, a sequence of less than <1000 bases can be determined from a single such reaction, the sequence of longer DNA molecules have to be pieced together from many such reads.

Using technologies available in the mid-1990’s, as many as 1 million bases of sequence could be determined per day. However, at this rate, determining the sequence of the 3 billion bp human genome required years of sequencing work. By analogy, this is equivalent to reading the Sunday issue of The New York Times, about 300,000 words, at a pace of 100 words per day. The cost of sequencing the human genome was a whopping  $70 million. The human genome project clearly brought forth a need for technologies that could deliver fast, inexpensive and accurate genome sequences.  In response, the field initially exploded with modifications to the Sanger method. The impetus for these modifications was provided by advances in enzymology, fluorescent detection dyes and capillary-array electrophoresis. Using the Sanger method of sequencing, one can read up to ~1,000 bp in a single reaction, and either 96 or 384 such reactions (in a 96 or 384 well plate) can be performed in parallel using DNA sequencers. More recently a new wave of technological sequencing advances, termed NGS or next-generation sequencing, have been commercialized. NGS is fast, automated, massively parallel and highly reproducible. NGS platforms can read more than 4 billion DNA strands and generate about a terabyte of sequence data in about six days! The whole 3 billion base pairs of the human genome can be sequenced and annotated in a mere month or less.

Continue to page 2.

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

Are You Ready for an FDA Inspection?

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

Don’t miss the Plenary Mock Food Safety Trial: Sam I Am who made Green Eggs and Ham is represented by Shawn Stevens vs. Food Safety victims represented by Bill Marler. Judged by Steve Sklare | November 30 at the 2017 Food Safety Consortium | Learn moreWith FSMA regulations coming into effect, food companies must prepare for the arrival of FDA investigators, as the agency has made it a priority to inspect U.S. food facilities, and they won’t always show up announced. Prior to an investigator’s arrival, it’s important to iron out several details in order to be adequately prepared. The following are 10 questions that every company should add to its pre-inspection checklist and make sure they are addressed before the inspection.

  1. Where will you meet? Pinpoint a place where you will host the FDA investigators. It should be a space that has enough room for them to review records, but it should not provide access to records (paper or digital) that could be viewed unsupervised.
  2. Who are the Designated Individuals? Assign a primary and secondary Designated Individual (DI) for each facility. This person serves as the liaison with the FDA investigators and should coordinate vacation time to ensure that one DI will always be available if FDA arrives. Although not required, the DI should also complete Preventive Control Qualified Individual Training.
  3. Has the written food safety plan been finalized? And, do the primary and secondary DIs know its components (i.e., GMPs, Sanitation Programs, Preventive Control Plan, Recall Plan, Environmental Monitoring Program, Foreign Supplier Verification Plan, Sanitary Transportation Plan, Food DefensePlan, and Produce Safety Plan)?
  4. Are records readily accessible? The DI should be able to immediately access any supporting records from the past three months for FDA review (FDA requires that most records are maintained for at least two years, but investigators usually ask to review the preceding three months).
  5. Have corrective actions been documented? When a deviation occurs, you must document all corrective actions. These actions should identify the deviation’s root cause and actions to prevent recurrence. If product safety is not affected, this should include a written conclusion that the deviation “does not create an immediate or direct food safety issue.”
  6. Have you conducted environmental monitoring and environmental sampling? If your company processes ready- to-eat food products that are exposed to the environment prior to packaging, FDA will require you to have an environmental monitoring program. In addition, the agency will collect 100–200 microbiological samples from your facility, so you need to know exactly what FDA will find before it arrives. By conducting your own FDA-style facility swabbing, you’ll be able to identify and immediately correct any hidden problems. It’s also important to develop your swabbing and testing plan with the help of legal counsel so that  the final testing results are confidential.
  7. Do you have a “No Photographs” policy? If not, you should. FDA Investigators will often insist on taking photographs while inspecting the processing environment. If your corporate policy prohibits visitors from taking photographs, you may in some cases be able to prevent FDA from taking pictures as well.
  8. Do you have a “Do Not Sign” policy? Sometimes, FDA Investigators will insist that a company representative sign a statement or affidavit during an inspection. You’re not legally obligated to do sign such a document. You should develop a policy stating you will neither sign nor acknowledge any written statements presented by FDA Investigators.
  9. Have you identified a suitable “on call” food industry lawyer? Add a food industry lawyer familiar with the inspection process to the company’s emergency contact list. This lawyer should be notified and remain “on call” during the inspection and serve as a resource to help answer any regulatory or investigator-related questions that arise during the process.
  10. Did you conduct a mock FDA inspection? One of the most effective ways to prepare for an FDA visit is to conduct a mock inspection. Food industry consultants and/or lawyers can visit your facility and play the role of the Investigator. Ask them to review your programs to identify possible regulatory shortfalls, and work with you to implement strategies that will strengthen your programs and reduce your regulatory exposure.

There are several more points to add to your pre-inspection checklist. To get the rest, attend the webinar, FDA Inspection Readiness Checklists, on March 28.

Dana Johnson Downing, TraceGains
FST Soapbox

Dispelling the Myth that Food Safety is Not a Competitive Advantage

By Dana Johnson Downing
7 Comments
Dana Johnson Downing, TraceGains

“Food safety is not a competitive advantage” is one of the barf-worthy “feel good” messages you hear from food industry executives during speeches and public forums. Last week at the Global Food Safety Initiative (GFSI) conference in Houston, an audience of more than 1,150 from 54 countries heard this tired mantra repeated during a panel discussion featuring CEOs from Mondelez, Cargill, Tysons and Wegmans. The common theme espoused by the CEOs was that food safety is a given and it’s just the right thing to do. Under their flawed rationale, because food safety is mandated, it cannot be a differentiator. Huh? That’s like saying monogamy in marriage is a given. Sure, most brides and grooms pledge faithfulness, but hey, we all know cheaters gonna cheat.

I wasn’t the only one who didn’t buy the food safety kumbaya message the CEOs were peddling. BBC business journalist Adam Shaw was the moderator for the panel and he grilled the CEOs to try to expose the fallacy that food safety is not a competitive advantage as nothing more than high-mindedness with altruistic notions, but the CEOs deflected his pointed questions and stayed on-message. I thought the song from the Lego movie, “Everything is Awesome” might start blaring from the sound system at any moment. What I cannot discern is if the CEOs really believe that food safety is not a competitive advantage, or do they feel compelled to say it to bolster confidence in the food supply.

I think we can all agree that consumers expect their products to be safe. Objectively, I think we must also agree that there are some companies in the food industry that simply do a better job of managing risk in their food safety system. As Warren Buffet once said, “Risk comes from not knowing what you’re doing.” Have you ever read the warning letters issues by the FDA? There are plenty of food operators who either do not know what they are doing or their profits are more important to them than the safety of the products they produce.

Perhaps the real reason these CEOs say food safety is not a competitive advantage is because they are trying to trick us with some twisted reverse psychology technique. More likely they avoid positioning their company as having an extraordinary food safety system because you can never eliminate all risk, and a recall or foodborne illness outbreak could be lurking just around the corner. That logic is a little lost on me, but okay.

What about food safety as a competitive advantage in the business-to-business (B2B) environment? With all the transactions between ingredient suppliers, brokers, distributors, co-packers and manufacturers, there is often friction between vendor and customer over food safety standards and the underlying documentation. Who you do business with matters more than ever before, especially now that there is greater supply chain transparency and process control mandated by FSMA. According to Brian Perry, senior vice president, food safety & quality at TreeHouse Foods, he has had to drop suppliers who are not FSMA-compliant because they pose too much risk. Meanwhile, companies are willing to pay a premium for suppliers who have their food safety documentation in order and routinely deliver on time and within specifications. So at least in the B2B marketplace, we can see that food safety can definitely provide a competitive advantage.

Pesky undeclared allergens and foreign material find a way to sneak into food production. Unsanitary conditions are sometimes permitted and product is adulterated. Mistakes are made, stuff happens, and sometimes food makes people and animals sick or even leads to death. So please don’t tell me that food safety is a given! If you want consumers to have confidence in our food supply, then tell them what your company does to try to prevent stuff from happening. Consumers’ appetite for information and knowledge about the food they consume is at an all time high. If consumers care about GMOs or how ethically-raised, humanely-treated, or sustainably-produced their food is, isn’t it logical to think they care about how companies develop a culture of food safety, the technology they use, and how strictly they monitor their suppliers? In order to make food safety a competitive advantage, food companies need to show supply chain partners and consumers that transparency isn’t just a buzzword. They need to show how they are operationalizing transparency to elevate food safety as a corporate imperative. Share your food safety story and respect your consumers enough to make up their own minds about whether your food safety system sets your brand apart.

Randy Fields, Repositrak
FST Soapbox

Foreign Supplier Verification Rule: Top 5 Questions Answered

By Randy Fields
No Comments
Randy Fields, Repositrak

The Foreign Supplier Verification Rule, part of FSMA, requires the importer of food to meet the same stringent guidelines found within FSMA’s Preventive Controls rule. Companies defined as the importer are now required to deploy a Foreign Supplier Verification Program (FSVP) that ensures their foreign supply partners are producing the imported food in compliance with processes that meet the FDA’s standards for preventive controls and safety.

Companies importing food products must anticipate hazards associated with the imported food and evaluate the risk posed by the food based on the hazard analysis and the supplier’s record of compliance every three years or when new information comes to light. In general, these companies must maintain the integrity of their extended supply chain.

Register for the Food Safety Supply Chain Conference | June 5–6, 2017 | Rockville, MD | in-person or virtualAnd now, the questions:

1.  Are you considered to be the importer under FSMA’s Foreign Supplier Verification rule?

Under FSMA, the importer is the U.S. owner or consignee of an article of food that is delivered to the United States from any other country at the time of U.S. entry. If you are still unsure as to whether you are the importer, try answering the three questions below. If you answer “me” to any of them, you might want to have your food safety team confirm your status as the importer with your foreign suppliers:

  • Who controls the finances of the imported food?
  • Who controls the agent?
  • Who controls the goods? Whose truck picks it up or in whose DC is the product stored?

2.  What comprises a FSVP?

The new regulation puts an additional burden on importers since it requires them to establish and follow written procedures for verifying foreign suppliers and correcting any violations of FDA standards. If you are considered the importer, you must have a separate FSVP in place for each food product and each foreign supplier, even if the same food is obtained from a number of suppliers. Proper documentation is essential to maintaining access to U.S. food markets since this will be the primary means by which FDA will establish compliance with FSVP. If you are not the importer, it might make sense to ensure you have copies of what your importer says he or she has on file.  (Hint: It’s a good idea to trust but verify in this situation.)

3. Can you meet the FSVP challenge?

Any record requested by the FDA must be available within 24 hours and could date two years back. If you don’t have an automated system, it’s time to consider one, as it’s really the only way to manage the range of documents required by a FSVP across a retailer’s or wholesaler’s vast supplier base. (Verification includes on-site audits, sampling/testing, records, certificates of conformance and continuing guarantees.)

4. What is the CEO’s responsibility under FSVP?

Senior executives in the extended retail food supply chain are personally responsible not only for their company’s compliance with FSVP, but also for verifying the compliance of their upstream supply chain.

5.  Why is Now the Time to Take Action?

Implementing a new system with suppliers will take time. It is your responsibility to ensure you and your suppliers are in compliance by the deadline. FSVP compliance goes into effect for most companies at the end of May 2017.

While we like to think of food safety as not being a competitive advantage, it can be used as leverage against the competition. So it’s critical to understand not only what the importer should be doing to comply with FSVP, but also what the supplier can do in advance to help the importer meet its obligations under the law.