Food accounts for one-third of the 42 million products imported into the United States each year, according to Andrew J. Seaborn, supervisory consumer safety officer, division of import operations, ORA, FDA. FSMA’s risk-based FSVP rule places responsibility on importers to ensure their food is safe, yet since the rule was implemented, the most common Form 483a observation has been a failure to develop an FSVP. In fact, from FY 2017 to present, the observation was cited 552 times, outweighing any other observation, said Seaborn at the recent Food Safety Supply Chain Conference, as he shared some of the latest trends in compliance and enforcement related to FSVP.
Thus far, common citations include:
No written hazard analysis to identify and evaluate known or reasonable foreseeable hazards
No written procedures that ensure appropriate foreign supplier verification activities are occurring related to imported food
Seaborn noted several additional “significant observations” related to FSVP inspections, including incorrect entry data, and the absence of documentation in the following areas:
Approval of a foreign supplier
Evaluating foreign supplier performance, along with related risks
Establishing written procedures to ensure foreign supplier verification activities are performed
Review and assessment of another party’s evaluation of foreign supplier performance
Ensuring food was produced in compliance with low acid canned foods regulations
Related to meeting the definition of a very small importer, when applicable
Main Points of FSVP
FSVP Inspections (Completed)
U.S.-based importers responsible to ensure safety of imported food
Last week USDA announced two Class I recalls involving possible foreign matter contamination. Perdue Foods, LLC has recalled about 31,703 pounds of certain ready-to-eat chicken products that may be contaminated with bone material. The products, which were shipped nationwide and include plastic trays of Simply Smart Organics Breaded Chicken Breast Tenders (gluten free and whole grain), and Chef Quik Breaded Chicken Tenders Boneless Tender Shaped Chicken Breast Patties with Rib Meat were produced on March 21. The full list of products is on the FSIS website and have the establishment number “EST. P-369” inside the USDA mark of inspection. Thus far there have been no confirmed reports of adverse reactions following consumption of these products.
Johnsville, LLC has recalled nearly 95,400 pounds of its ready-to-eat jalapeno cheddar smoked sausage products after a consumer complaint involving green hard plastic in the product. The 14-oz packages of the product were shipped both nationwide and internationally, were produced on March 12 and 13, and have the establishment number “EST. 34224” inside the USDA mark of inspection. Thus far there have been no confirmed reports of adverse reactions following consumption of these products.
Last week industry gathered for the Food Safety Supply Chain conference at USP in Rockville, MD. The following are some quick highlights of insights they shared.
Most Common Form 483 Observations
Following FSVP inspections, the most common Form 483 observation was a company’s failure to develop an FSVP. From FY 2017 to present, the observation was cited 552 times, outweighing any other observation and underscoring the need for an educational component. – AJ Seaborn, supervisory consumer safety officer, division of import operations, ORA, FDA
(left to right) AJ Seaborn, Lisa Ross and Priya Rathnam of FDA share an update on FSMA implementation at the 2019 Food Safety Supply Chain Conference
Top Citations for FY 2018
Hazard analysis (when a facility is not identifying a hazard that requires a preventive control)
Lack of a food safety plan. “There’s still work to be done on the education and outreach on this one.”
Equipment and utensils (GMP deficiency)
Allergen controls monitoring
Sanitation control verification procedures
Personnel (usually, this is related to a repeated issue)
– Priya Rathnam, supervisory consumer safety officer, CFSAN, FDA
Critical Supplier Questions Must Be Asked
How do you choose and approve your suppliers?
What must be done to ensure that we aren’t receiving hazards from suppliers?
What requirements must be defined?
Does every supplier need to be audited?
Should we treat all suppliers equally? (No, it depends on their risk profile)
How do we ensure that our program is effective?
When working with suppliers, it’s important that your decisions are reproducible and that you apply the same risk methodology across the board. – Erika Miller, food safety specialist, D.L. Newslow & Associates, Inc.
“Before you can do anything to transform your business, you have to have visibility in your supply chain.” – George Dyche, senior director, innovations & solutions, Avery Dennison
“’Compliance’ should be replaced in industry with ‘commitment’…when you’re committed, compliance will follow.” – Felix Amiri, food sector chair, Global Coalition for Sustained Excellence in Food & Health Protection (GCSE-FHP)
Putting the “P” in CAPA = Getting out in front of issues before they happen. “Don’t wait for the consumer to get sick… if you have a recall, it means you haven’t done your work on the CAPA side.” – Andrew Kennedy, director, Global Traceability Center, IFT
(left to right) Felix Amiri, Lucy Angarita and Andy Kennedy discusss supply chain vulnerabilities and solutions.
On critical success factors to establish a traceability program: Technology will never fix a company’s data quality or process issues. If you don’t already have it defined, you won’t get there. And after you understand the KPIs and goals, don’t give up. This doesn’t happen overnight. Engage your leadership, because the vision has to be from the top for others to also allocate the time and effort. “It’s a journey, not a destination. If you take your eyes off data quality, data quality goes down.” – Lucy Angarita, director, supply chain traceability, IPC/Subway
In 2018, 47% of recalls were allergen related, and this rate has increased. “People still don’t get [allergen labeling]”. – Barry Parsons, senior consultant, PTI Consulting Group (Division of Paster Training)
On the significance of teaching truck drivers the importance of food safety risks: “They are part of our supply chain, and we need to incorporate them. It shouldn’t be out of sight, out of mind.” – Holly Mockus, senior industry analyst, Alchemy
Trish Wester, chair of The Association of Food Safety Auditing Professionals, leads an FDA panel discussion about the Third-Party Certification Program. (left to right) Doriliz De Leon, program coordinator, accredited third-party certification program, FDA; Marla Keller, biologist, FDA; Marianne Fatica, policy analyst, Office of Compliance, FDA; Clinton Priestley, consumer safety officer, audit staff, human and animal food operations, ORA, FDA
ADM Milling Co. announced that it is expanding a current recall to include all five-pound bags of Baker’s Corner All Purpose Flour that is packaged for ALDI due to possible presence of E. coli. The issue was uncovered when the Rhode Island Department of Health conducted testing of the product.
The particular strain of E. coli has been connected to 17 illnesses in eight states, but the recall affects flour that was distributed in ALDI stores in 11 states (Connecticut, Delaware, Massachusetts, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Vermont and West Virginia.
The previous recall only affected two lots of the five-pound bags of flour. ADM Milling is advising consumers against consuming flour that has not been thoroughly cooked.
As the use of technology in manufacturing and quality continues to expand, there are many opportunities to help food companies streamline operations and enhance efficiencies. During a brief chat with Food Safety Tech, Melody Ge, head of compliance at Corvium, Inc. talks about the benefits of using technology in manufacturing and why some companies may be hesitant to take the leap.
Food Safety Tech:Your recent Food Safety Tech article, “Changes in the Food Safety Industry: Face Them or Ignore Them”, highlighted the role of technology in improving efficiency. What are the top areas in which companies are challenged to streamline processes?
Melody Ge, head of compliance at Corvium, Inc.
Melody Ge: When talking about a company’s production process, the challenge usually comes from where to start. A company may have difficulty figuring out which areas in the processing line can either be automated or how they can use technology as an advantage.
The challenge could also come from the fact that only parts of the process can be automated with the current technology. For example, with hazard analysis or risk assessment—those processes still need the human brain. So within a process, part of it can be automated, and part of it can’t—that could be another challenge.
FST: What technologies can food companies use to better help them manage risk in manufacturing?
Ge: It depends on what’s out there and what products a company is producing. From a manufacturing perspective, they can use supply chain management software or document management software to help them manage their approved supplier program. Using technology can make it easier and more efficient for companies to manage the risks from incoming goods and suppliers as it centralizes their documentation to make it easy to access.
Technology also helps companies use online software to centralize training documents on one corporate site and deploy it to all employees at different levels.
And from a HACCP and Preventive Controls perspective, companies can use digital technology to document temperature, pH Value, humidity, pathogen testing results, etc.—all the types of data that help execute a HACCP plan can be automated and help manage risk. After all the information is centralized and digitalized, you can see the data and easily translate that to help manage risk.
FST: What are the current technology adoption hurdles, and how are you helping companies understand the value of technology versus a paper-based system?
Ge: I think some hurdles come from fear: What’s going to happen as a result of technology is unknown, and especially at this stage, how FDA will respond is unknown. FDA already announced that this smarter food safety era is coming, but no one knows whether there will be new requirements as a result. Will requirements change because manufacturers are using new technology? Those unknowns make manufacturers fearful about what’s going to happen.
Another fear factor is job loss. For example, if processes are automated, or AI is used to capture data, or record keeping is automated, then what am I going to do? Does the company still need me as a QA professional or supervisor? I think those can stand in the way of making changes. However, [companies or employees] shouldn’t think that way. Technology is not replacing QA professionals, but [rather it] helps them do higher-level jobs. For example, in the time saved by technology, QA professionals can read and digest the data results, and study the trends and recommend best practices to continuously improve their food safety management system. It makes their time more valuable to the company.
Another hurdle is understanding which steps in processes can be automated. There are so many technologies out there that have pros and cons, and whether it will fit with the manufacturer or the facility—there’s an overwhelming amount of information, and the QA technician needs time to digest and understand the process at the facility as well as the technology out there to then select the most suitable technology for a process.
As far as helping companies understand the ROI of technology, there are four areas where I think technology can add value:
It provides increased efficiencies and accuracy of daily operations and data collection. It reduces human error. Let the technology help the food safety professionals document daily operational data.
It streamlines the food safety management system for continuous improvement. Because technology helps the food safety professional do the job of daily data collection, the time saved can be used wisely to study the data and outcomes, and truly understand how they can bring their food safety management system to another level.
It centralizes all the documents and records for management. Using technology, the food safety professional can see their SOPs, records and any related documents in one place. They don’t have to physically go to several places to see what’s happening operationally. This can also help increase efficiency during the audit process.
Centralized data helps the food safety professional more easily see where the deficiencies are located.
Ultimately, the ROI is that advanced technology can help the food safety professional increase operational efficiency, reduce product waste and production downtime.
FST: Any additional comments about the role of technology in food manufacturing?
Ge: In echoing on FDA’s announcement, although the smarter food safety era comes with using advanced technology, the mentality has not changed as all—it’s always FSMA based and people led. We need people to use the technology, and that foundation isn’t changing. We are protecting our consumers from any potential food safety risk. We’re just using a more efficient way to help all of us achieve this goal. I believe in the future, all food facilities will use at least one technology out there to help them automate one or more processing steps. And if you start with one step at a time, it will generally take over the entire production process.
A recall or outbreak occurs. Consumers stop buying the food. Industry responds with product innovation. Government enters the picture by establishing standards, initiatives, etc. “That’s my thesis about how changes happen,” said Michael Taylor, board co-chair of Stop Foodborne Illness during a keynote presentation at last week’s Food Safety Summit. Industry has seen a positive evolution over the past 25-plus years, but in order to continue to move forward in a productive direction of prevention, progress must be made without waiting for the next crisis, urged the former FDA commissioner for foods and veterinary medicine.
The strong foundation is there, Taylor added, but challenges persist, including:
FSMA. There’s still much work to be done in establishing accountability across the board, including throughout supplier networks.
Lack of technology adoption. The failure to use already available tools that can help achieve real-time traceability.
Geographic hazards. This is a reference to the contamination that occurred in the cattle feedlot associated with the romaine lettuce outbreak in Yuma, Arizona. “We’re dealing with a massive hazard…and trying to manage the scientific ignorance about the risk that exists,” said Taylor. In addition, in February FDA released its report on the November 2018 E.coli O157:H7 outbreak originating from the Central Coast growing region in California, also implicating contaminated water as a potential source. “There are still unresolved issues around leafy greens,” Taylor said. “What are we going to learn from this outbreak?”
Taylor went on to emphasize the main drivers of industry progress: Consumers and the government. Consumer expectations for transparency is rising, as is the level of awareness related to supply chain issues. Social media also plays a large role in bringing consumers closer to the food supply. And the government is finding more outbreaks then ever, thanks to tools such as whole genome sequencing. So how can food companies and their suppliers keep up with the pace? A focus on building a strong food safety culture remains a core foundation, as does technological innovation—especially in the area of software. Taylor believes one of the keys to staying ahead of the curve is aggregating analytics and successfully turning them into actionable insights.
Frank Yiannas is the keynote speaker at the 2019 Food Safety Consortium | October 1, 2019 | Schaumburg, IL | He is pictured here during at town hall with Steven Mandernach (AFDO), Robert Tauxe (CDC), and Paul Kiecker (USDA)
FDA recently announced its intent to put technology innovation front and center as a priority with its New Era of Food Safety initiative. “This isn’t a tagline. It’s a pause and the need for us to once again to look to the future,” said Frank Yiannas, FDA’s deputy commissioner for food and policy response during an town hall at the Food Safety Summit. “The food system is changing around us dramatically. Everything is happening at an accelerated pace. The changes that are happening in the next 10 years will be so much more than [what happened] in the past 20 or 30 years…We have to try to keep up with the changes.” As part of this “new era”, the agency will focus on working with industry in the areas of digital technology in food traceability (“A lack of traceability is the Achilles heel of food,” said Yiannas), emerging technologies such as artificial intelligence and machine learning, and e-commerce. Yiannas said that FDA will be publishing a blueprint very soon to provide an idea of what areas will be the main focus of this initiative.
Thank you to everyone who participated in our latest FSMA IQ test, which focused on the supply chain. This series was developed by Kestrel Management. If you have any questions about the results, we encourage you to leave a comment.
We also invite you to learn more about important supply chain issues at our Food Safety Supply Chain Conference later this month, May 29–30. You can attend in person or virtually.
Control limits must be included within the hazard analysis and preventive controls for HACCP.
FALSE. More clarification is needed here, as 96% of respondents said this is true.
CCPs previously established under HACCP or previous hazard analysis may be a preventive control under FSMA.
TRUE. 91% got this right.
Product testing for pathogen or indicator organism is not addressed under FSMA verification and reevaluation.
FALSE. 87% answered correctly.
You must document justification of records not required by a food safety plan in a food operation under FSMA.
TRUE. Just 44% responded “true”.
You must implement corrective actions and corrections properly, including procedures to address the presence of organizations in ready-to-eat as a result of product testing.
TRUE. Congratulations, 100% got this one right!
Under section 117.150, you must implement corrective actions based on your determined response for all affected food as evaluated.
FALSE. This seems to be another area that needs clarity: Just 13% answered “false”.
Under FSMA supply chain requirements, you must document approved suppliers.
TRUE. Once again, great job—100% answered correctly!
A foreign supplier of food to the U.S. must ensure that all the requirements of a FSMA Food Safety Plan under cGMP117.126 be met for the manufacture of the food being exported to the United States.
TRUE. 91% knew this one.
A food broker of foreign-supplied product to the U.S. does not have any responsibility of meeting the FSMA requirements.
FALSE. 91% answered correctly.
Data sets must be shared between shippers, carriers, loaders & receivers to ensure rules are properly implemented.
TRUE. 74% answered correctly.
Only the personnel of the carriers transporting food product require training and training records.
FALSE. 96% got this one right.
Shipper & carrier can agree to a condition & temperature monitoring mechanism for foods that requires temperature control for safety.
“Simply put, the Food Safety Modernization Act (FSMA) means that it’s no longer acceptable to have a reactive food safety policy. There is a new emphasis on proactive measures to safeguard public health.
That said, whether your pest control is managed in-house, or you hire a professional pest management company, odds are “service” is focused on the rote practice of trap checking, which is neither cost-effective, nor does it provide the holistic IPM strategy that focuses on proactive inspections that ensure FSMA compliance.
You should be challenging your service provider, holding them to the standard of this new obligation. To understand the state of the industry and what food managers need to be considering when it comes to rodents, I contacted Richard Kammerling, founder of RK Pest Management Services, whose half-century of experience gives him a unique vantage on the hallmarks of an expertly managed food safety program – past, present and future.
Joe Barile: How would you characterize the current state of the industry?
Richard Kammerling: The food industry has a problem where they sometimes assume everything is fine even when it’s not. And sometimes they’re not willing to pay the price to make sure their program is working properly until they have a real problem. One of the biggest problems in the food industry is they underestimate the time that is needed to properly perform a pest management program. The food industry tends to be reactive rather than proactive. If they’re not given the information to know a condition could be or is an issue, then they don’t address it as such.
Barile: So, what should food managers be requiring from service providers?
Kammerling: Service providers should be acting as diagnosticians. Say, through trap-checking, we found one mouse in a trap. Is it only one mouse? Or is it an infestation? What are the conditions that caused it? Most of the pest control industry is going around the perimeters, but they’re not doing the entire scope of the food warehouse.
If you can find a pest-vulnerable condition and eliminate it, that’s the key to an effective IPM program. Collecting data can help you find some of these conditions, but analysis of that data and inspections are key to a pest management program – and that’s what food safety managers should be demanding of their pest managers, internal or external. Most pest control today is based on trap checking and does not leave enough time for inspections or data analysis….”
Food Safety Tech’s FSMA Supply Chain IQ test series continues with Part II. The test was put together by the subject matter experts at Kestrel Management, LLC. Before taking Part II, let’s review the results from Part I below. (If you have not taken Part I, take the test now!)
FSMA requires all records for the reevaluation of cGMPs every three years.
FALSE. Only 28% knew this.
Implementation records are required for every FSMA requirement.
TRUE. 74% got this right.
Under some circumstances, FSMA requires that conformance of a customer’s control of a hazard is required.
TRUE. 90% answered correctly.
Under FSMA cGMPs, you must be able to identify at least 95% all possible contaminated product.
FALSE. Respondents were almost evenly split. 51% answered correctly.
Monitoring of frequency of preventive controls must be conducted by the operation as part of the food safety plan.
TRUE. 92% answered on target.
Written supply chain plans are not included in FSMA food safety plans.
FALSE. 81% answered correctly.
Mandatory recalls are provided under FSMA as a new requirement.
TRUE. 63% answered correctly.
Verification effectiveness of the implementation of preventive controls needs to be evident but not documented under FSMA.
FALSE. 74% got this right.
cGMPs under FSMA require that outer garments be suitable to protect against allergen contamination.
TRUE. 77% answered correctly.
You do not need to document records of all product testing under FSMA.
FALSE. 82% answered correctly.
FSMA preventive controls does not require hazards be addressed under the HACCP plan.
FALSE. 69% got this right.
The food safety plan does not require hazards that are unintentionally introduced within an operation’s processes.
FALSE. 82% answered correctly.
Surprised by the results? Provide feedback in the comments section.
We invite you to take Part II below and then learn more about important supply chain issues at our Food Safety Supply Chain Conference, May 29–30. You can attend in person or virtually.
One of the Tyson products involved in the recall. FSIS has provided a list of all the labels on its website.
Over the weekend Tyson Foods, Inc. announced an expanded voluntary recall of its frozen, ready-to-eat chicken strips due to more issues involving contamination with metal fragments. The initial recall occurred on March 21 and involved 69,093 pounds of product. All RTE chicken strips under the Class I recall have the establishment number “P-7221” on the product package and were produced between October 1, 2018 and March 2019, with “Use By Dates” of October 1, 2019 through March 7, 2020. The products were shipped nationwide to retail and Department of Defense locations, as well as to the U.S. Virgin Islands.
“Our company is taking corrective action at the location that makes these products. We have discontinued use of the specific equipment believed to be associated with the metal fragments, and we will be installing metal-detecting X-ray machinery to replace the plant’s existing metal-detection system. We will also be using a third-party video auditing system for metal-detection verification,” said Barbara Masters, DVM, vice president of regulatory food policy, food and agriculture for Tyson Foods in a company news release.
Thus far there have been six consumer complaints involving metals pieces, with three people claiming oral injury.
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