Last week a panel of industry authorities gathered to share their perspectives on the importance of transparency in the supply chain and the challenges that food companies experience in managing different aspects, from their suppliers to once product reaches retailers.
“Understand that food safety today has changed significantly and will continue to change. It’s a dynamic field and regulations have only accelerated,” said Jorge Hernandez, chief food safety officer at The Wholesome Company. “You need to be more proactive internally and externally.”
Moderated by John Wadie, U.S. marketing operations manager for 3M Food Safety, the other panelists were Melanie Neumann, president of Neuman Risk Services, LLC and Terry Levee, Senior Director, Giant Eagle.
Food importers have clear objectives: To successfully bring safe food into the country by clearing U.S. Customs and Border Protection, to avoid FDA detention and to conduct business competitively in the United States. Under the FSMA final rule on Foreign Supplier Verification Programs (FSVP), importers must ensure their food is as safe as if it were produced in the United States and that it is not adulterated or misbranded.
Compliance, of course, is of utmost importance when it comes to avoiding issues with the FDA. However, in a more realistic sense, the best way to stay out of trouble with FDA is to avoid two circumstances, advised Russell Statman, executive director at Registrar Corp. (the firm is a U.S. agent for about 15,000 foreign facilities)—being dishonest and not taking the requirements seriously.
“Once you fall into one of those boxes, you’ll never get out,” Statman said. “It’s important when dealing with FDA to remember that. It’s not a building; it’s people. They don’t want to stop your shipments; they want to facilitate trade.” If your company is honestly working toward and making an effort to follow the rules, “FDA will keep working with you until the cows come home,” he said.
Statman discussed practical information surrounding FSVP that importers should consider during the Food Safety Supply Chain Conference earlier this week. Although there is flexibility built into the FSVP rule (as there is with all seven FSMA rules), importers must follow the law. To start, every importer must have DUNS number (provided by Dun & Bradstreet), which is free of charge. However, this can be a challenge for foreign companies, particularly those in China, according to Statman, who also said there may be instances in which Dun & Bradstreet tries to charge a fee. “It’s supposed to be free and quick. If you have problems with Dun & Bradstreet, you want to let FDA know.” He offered key pieces of advice for the FSVP requirements:
Hazard analysis. “You can’t rely on other people. If you’re producing food, do your own hazard analysis. Create a pamphlet that you can give to your customers. Then you don’t have to deal with all these requests—keep updating [the pamphlet], so it’s a living document. If you’re a foreign supplier and have a booklet, you’re steps ahead of your competition.”
Approval and compliance status review of suppliers: Check their record with FDA to find out whether they have any warning letters or on import alert. “That doesn’t mean you can’t buy from them, it just means you have to investigate what the problem is,” said Statman, but added that a lot of U.S. companies will not buy from importers that are flagged with an alert. And in many cases, companies do not know that they’re on import alert, so visit FDA’s website frequently to make sure you’re not on the list. “FDA doesn’t tell you when you’re on import alert. You want to check [because] asking them might not be good enough.”
Supplier verification activities: Verify that importers follow the entire rule.
Corrective actions
Periodic reassessment of FSVP
Importer identification at entry (DUNS number)
Recordkeeping: “In a very real, practical sense, your record stays with you,” said Statman. “If you’re an importer, you don’t want your shipment detained by FDA.” FDA uses a computer system called PREDICT that determines which entries they stop. The system comes up with a score for shipments that are at the highest risk. “Your PREDICT score if very important—some of these factors are secret, [and] some are public. The most important are in your control—your record and the importers record,” he added. “Before you send your first shipment for a new product, make sure everything is correct (i.e., registration, labeling). It’s worth the time.”
The complimentary webinar, Top Tips to Mitigate Food Fraud, takes place on June 22 at 1 pm ET. Register now.Recently, the topic of food fraud has been discussed with increasing urgency. From understanding the basics of what is food fraud to navigating the regulatory requirements, quality assurance, compliance and procurement professionals must have a general understanding of the components.
An upcoming free webinar will review the hazard analysis requirements surrounding the FSMA Preventive Control for Human Food, GFSI requirements for raw materials and risk assessments and food fraud mitigation plans. Attendees will also learn about food fraud mitigation implementation strategies. The speakers participating in this webinar are Jeff Chilton, vice president of professional services at Alchemy Systems and Peter Claise, marketing director for foods programs at USP.
With several FSMA compliance dates now in effect, much of the focus is on where companies need help. According to Kathy Gombas, former deputy director at CFSAN, the industry is struggling with FSMA training. Many companies don’t understand the FSMA rule exemptions and supply chain requirements, and they just don’t know where to start. “Industry needs affordable and timely resources,” said Gombas during a panel discussion at the Food Safety Summit earlier this month. “There are a lot of tools out there, but they’re costly.”
Efforts are underway to address these challenges. FDA has issued more than a dozen guidance documents pertaining to the rule. In addition, tools such as model plans and templates can help companies with their food safety plans, and the agency is almost ready to publish a web-based food safety plan builder that will be freely accessible on FDA’s website, according to Gombas. Several sources of technical assistance are available, including state and trade associations, academia, and the technical assistance network (TAN). However, when companies have inquiries, the key is to provide them with a response in a timely manner, said Gombas.
The Produce Safety rule is another hot spot for hurdles. Although 90% of it aligns with Good Agricultural Practices that have been in place for more than a decade, industry’s response to the rule remains one of fear and confusion, said David Gombas, former vice president of technical services for the United Fresh Produce Association. “Water testing is probably the most complicated aspect of the regulation,” he said. The rule calls for testing procedures that many produce companies never had to conduct before. Some testing must be done within a certain period of time, and the lower number of testing labs in rural areas of the United States will pose a problem for some producers, warned David Gombas.
There is also confusion among producers regarding whether they should follow the Produce Safety Rule or the Preventive Controls rule, which could significantly impact the steps they must take to be in compliance of either rule. To further complicate matters, Gombas pointed out that many foreign suppliers aren’t even aware that they have to be in compliance with the rule. Finally, the Produce Rule does provide a lot of room for flexibility, so Gombas predicts much of the responsibility will fall on the agency inspectors and how they expect rule to be met.
How an organization identifies itself as an importer of food at entry into the United States
Requirement to provide a unique facility identifier that is acceptable by FDA
Information on what to do if the importer cannot obtain a Dun & Bradstreet Data Universal Numbering System number in time for the compliance date
FDA also identified the importers that fall under the May 30, 2017 compliance date. The foreign supplier would fall into one of the following categories:
The supplier will not be covered by the FSMA PC or Produce Safety rules
The supplier is subject to the Preventive Controls for Human Food rule and is not a small business, qualified facility or subject to the Pasteurized Milk Ordinance
The supplier is subject to CGMP requirements in the FSMA Preventive Controls for Animal Food rule and is not a small business or qualified facility
For importers that are unsure as to whether they are required to comply with the FSVP rule, the agency released a one-page chart, “Am I Subject to FSVP?”, along with a fact sheet about the final rule and the requirements under it, compliance dates and additional information.
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.
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.
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:
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.
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.
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.
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.
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.
A new version of SQF was recently released. To get up to speed on the revisions, experts LeAnn Chuboff, senior technical director at SQFI and Jennifer Lott, food safety & auditing technical manager/senior safety auditor at SGS will walk attendees of an upcoming webinar through SQF V8 and how it connects to FSMA compliance.
Chuboff and Lott will discuss the role of senior management in the process, the need for greater environmental controls, approved supplier programs, and the requirements surrounding food fraud and allergens. They will also help attendees understand the tools and resources available to help prepare for the new version, along with digging deeper into FSMA implementation in the area of risk, supply chain preventive controls, adulteration and allergens.
Identifying, prioritizing and managing supply chain risks is critical to maintaining FSMA compliance. Under the Preventive Controls rules, food companies must implement a hazard identification system for any known or foreseeable hazards. During an upcoming webinar, David Acheson, Ph.D. and Miles Thomas will discuss how data can help companies manage supply chain risk, methods for analyzing and prioritizing hazards, and mitigating risk to achieve FSMA compliance. They will also shine a spotlight on global trends in food safety and authenticity threats.
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