Since 2002, the amount of FDA-regulated food imported to the United States has nearly doubled. With the implementation of FSMA well underway, expect that FDA will be increasing its inspections at foreign manufacturing facilities. When prioritizing inspections, FDA looks at a facility’s compliance history, the risk of the product manufactured in the plant, the date of its last inspection, and any import alerts associated with the site.
First and foremost, it’s important to make sure your foreign facility understands what a food safety plan under FSMA requires, said Chengboey Lau, principal scientist for North America scientific & regulatory affairs at Mondelēz International. Today at the GMA Science Forum Lau pulled from the experience of Mondelez (the $30 billion-company has more than 165 manufacturing plants worldwide and requires all of its suppliers to be GFSI certified) to provide some helpful tips on how a company can get ready for an FDA inspection of a foreign facility, what it should do during the event, and the steps that should be taken afterwards.
Prepare for the Inspection
Develop an internal policy for foreign inspections
To ensure readiness at all times, implement a proactive program that involves the following activities
Annual review of registered facilities
Review of any products or materials made for U.S. markets (including R&D samples)
Gap assessments to ensure compliance with FDA requirements, followed by an action plan to close identified gaps
Employee training on FDA requirements
Create a site-specific FDA inspection manual for all necessary documentation
Survive the Inspection
Align expectations with the inspector at the start of the inspection
Have an employee who has strong English skills present to help with translation (the employee should have an understanding of American slang, too)
Consider having a U.S. regulatory support colleague available for questions during the inspection
Post-inspection
Email the inspector or make a Freedom of Information Act request if you don’t receive an establishment inspection report after six months
If a form 483 letter is issued, respond in writing within 15 days, and follow up within 40 days to inform FDA of the completion of any corrective actions
At the end of the day, make sure you have a firm understanding of which final FSMA rules apply to your organization, advised Lau. From there companies should perform a gap analysis, identify the resources necessary and any constraints involved, train employees on the new FSMA expectations, and be prepared to implement new and/or modify current policies and procedures to ensure inspection readiness.
A new PCR yeast and mold test that provides results in just four hours is available for finished dairy products. Developed by Germany-based Biotecon Diagnostics, the foolproof yeast and mold quantification test has demonstrated 100% specificity with 290 strains, representing 260 species with all phylogenetic groups included, according to a release from Weber Scientific. It also demonstrated 100% exclusivity with 60 strains of non-target microorganisms typically found in similar ecological niches (Sensitivity is 101 – 102 cells / g depending on sample type).
“This test is based on well-established real-time PCR technology,” said Phil Coombs, product specialist at Weber Scientific. “There is a high degree of correlation between conventional methods and PCR. Results are displayed in CFU per gram and only viable organisms are detected…The real cost benefits will be achieved by how much more quickly can product be shipped and how many recalls avoided.”
Food Safety Tech recently sat down with experts from Eurofins to discuss FSSC 22000. According to Kristopher Middleton, technical manager at Eurofins, and Kim Knoll, food safety systems national sales manager at the company, there are still quite a few companies (especially in North America) that are unfamiliar with the ins and outs of the certification scheme. In a Q&A with FST, Middletown and Knoll break down the basics of FSSC 2000, along with explaining some of its benefits.
Kristopher Middleton, technical manager, Eurofins
Food Safety Tech: How is the trend with FSSC 22000 evolving?
Kristopher Middleton: The scheme started in 2009 based on a demand for people wanting to have an ISO-based certification within the GFSI benchmarking process. When the program came out, it trended toward larger companies that already had ISO-based certifications, mainly ISO 22000 and ISO 9001. The FSSC 22000 scheme is the fastest growing GFSI benchmarking scheme currently. It’s not just for large multinational companies; a lot of smaller suppliers are seeking certification to this scheme. The foundation continues to expand its scopes to become a true farm-to-fork certification program.
FST: Is FSSC 22000 also appropriate for a single site or for a company with fewer than 50 employees?
Middleton: The certification doesn’t discriminate based on facility size—nor footprint or number of employees. It’s ideal for any company that has a robust food safety management system and manufacture products that fall within the FSSC 22000 scope of certification. This currently includes manufacturers of perishable animal products (feed and food), perishable vegetable products, products with a long shelf life, biochemical products (i.e., food ingredients, vitamins, biocultures, etc.), manufacturers of food packaging, and primary production of animal products.
The key thing about FSSC 22000 certification is that it is not a terribly prescriptive food safety scheme, when compared to others that are available. You will be successful with FSSC 22000 certification if you are confident and knowledgeable about your own food safety management system, and you have appropriate justification or validation for the method in which your programs have been implemented, as well as validation for the controls of your food safety hazards.
FST: Are there quite a few companies that have not heard of FSSC 22000 or are not aware that it is a GFSI-recognized scheme?
Middleton: Since ISO 22000 was not terribly popular here in North America, it didn’t catch on right away. It was more so overseas that it caught on. However, within the past two years the scheme has become increasingly popular here, especially among companies that have other ISO standards already implemented (i.e. ISO 9001, 14001, 18001,etc), where it relates to occupational health and safety, environmental, and quality. The reason for that is the FSSC can easily intertwine with that entire management system program so that it all works together versus having separate programs in place.
Kim Knoll, food safety systems national manager, Eurofins
Kim Knoll: I’m having a lot of conversations with smaller manufacturers who are brand new to GFSI. Many of them are being asked by their customers to achieve a GFSI benchmarked certification and are in the early stages of researching scheme options. Some of these companies are surprised to learn that FSSC 22000 is a viable option. Like other certification schemes, Eurofins lends support to companies planning to pursue FSSC 22000 through training courses, consulting services, pre-assessments and ultimately certification services. Even though FSSC 22000 is a newer scheme, auditor availability is not an issue.
FST: What are the key differences between FSSC 22000 and the other GFSI schemes?
Middleton: Probably the most apparent difference with FSSC compared to other GFSI benchmark schemes is the fact that your certification lasts for three years, not one year. The reason for that is that it’s not a product-based certification like the others, it is a process-based certification and it uses the accreditation standard of ISO 17021 not ISO 17065. It also uses ISO 22003 for direction to the certification body for the conducting of the audit. That doesn’t mean that sites won’t be audited annually; it just means that once the certificate is granted, it’s good for three years.
Another key difference is that there is no true pass or fail within the audit. It’s a conform or not-conform audit. The decision to certify is based off the findings from the auditor and their recommendations, as well as the decision from a technical review meeting at the certification body. It requires the effective closure of a particular non-conformance or satisfactory plan being submitted for the closure of those non-conformances before the actual certificate can be granted. So that’s a bit different, because you can just submit plans for your non-conformances [instead of] actually showing that everything has been completely resolved. That being said, if a facility isn’t able to hold or get a certificate, if there’s an imminent food safety threat noted during an audit—if there’s an issue, such as a potential recall or contaminated goods, the ability to be granted that certificate is not feasible.
FST: Can you walk us through the auditing and certification process under FSSC 22000?
Middleton: Like any of the standards out there, you can get a pre-assessment, which is not necessarily part of the certification activity. The certification activity starts at a Stage 1 audit within this scheme (also known as a document audit within other schemes). It’s an evaluation of a facility’s food safety management system document to determine if they’re valid. The process does not include an entire evaluation of the implementation of the program, just simply that the programs are adequately designed and meet the requirements that are in place.
Next there’s a Stage 2 audit (sometimes referred to a facility audit) that is conducted no more than six months after the Stage 1 audit. The Stage 1 audit will identify the areas of concern—programs that might not meet exactly what the specifications required within the standard, which would become non-conformances in a Stage 2 audit (also called a facility audit or certification audit).
The Stage 2 audit is the full evaluation of the implementation of the program that was reviewed in the Stage 1 audit. Following completion of the audit, effective closure of non-conformances is required. This closure can either be [related to] major non-conformances, CAPA or root cause analysis. You have to supply evidence that the non-conformance is properly eliminated and will not recur, and this evidence must be supplied to the certification body and the auditor for review.
Any other non-conformances (also known as minor non-conformances) must have corrective action plans. Companies need to state how they plan on resolving the issue. They will be “closed” but left open for the next audit, which has to occur within one calendar year (known as a surveillance audit). The term “surveillance audit” within this standard is different from some of the other standards. Within some of the other standards, a surveillance audit is not a yearly activity—it is done within the year of certification. The surveillance audit within this standard is a yearly audit that is required to meet the requirements of GFSI. It’s also a requirement within [ISO] 17021 and [ISO] 22003 that surveillance audits are conducted. The GFSI requirement changed the surveillance audit within the ISO world because they used to do a sampling audit, which progressed to a full-blown audit. Your whole food safety management system will be evaluated, which is slightly different from ISO 22000 surveillance audits.
After that audit is conducted, you have another surveillance audit in the following calendar year. Within those surveillance audits, if any minor non-conformances or non-conformances from the previous audit are still present, they are upgraded to major non-conformances and [companies] would have to implement a full corrective action plan, root cause analysis, etc. and then determine the solution.
Once the second surveillance audit is conducted, the following year will be your recertification audit, which is simply another facility audit. It’s not a document audit—you don’t have to do Stage 1 audits after that initial one. This recertification audit occurs prior to your certificate expiring.
In remarks made at the Consumer Federation of America’s annual food policy conference this week, Benjamin C. Mizer, principal deputy assistant attorney general, stated that the federal government has made consumer safety a top priority. With this announcement comes an announced intention on the part of the U.S. Department of Justice (DOJ) to use “various enforcement tools that we have at our disposal,” and maintain a stronger partnership with FDA to go after companies that “introduce adulterated foods into interstate commerce”.
“In deciding whether to use our civil or our criminal enforcement tools, the Justice Department follows the same set of guidelines that apply to every criminal prosecution,” said Mizer. “Among other things, prosecutors evaluate the nature and seriousness of the offense, the deterrent effect of the prosecution and the culpability of the individuals or entities involved.” Criminal charges brought against a food company can be either misdemeanor or felony, and Mizer emphasized that misdemeanor violations can still result in “serious penalties”. He cited a case in which the owner and CEO of an egg production company in Iowa pled guilty to a misdemeanor and received three months in jail and one year supervised release, and was slapped with a $100,000 fine.
“In some cases, the facts are so egregious that it is appropriate for the Justice Department to bring the full force of the law to bear,” stated Mizer. “When we can show an intent to defraud or to mislead consumers or the FDA, a defendant can face felony charges.” To illustrate this scenario, Mizer referred to the landmark case against the Peanut Corporation of America, which is perhaps the most commonly referenced case in recent months, as many in the industry have voiced their opinion that it has set a precedent as to how the government will handle such situations moving forward.
How ready is your company for FSMA compliance? 69% are somewhat ready, 25% are ready, and 6% are not ready at all, according to a recent survey. (Click to enlarge)
Many companies need to prepare for FSMA compliance by September, yet three out of four only consider themselves “somewhat ready”, according to a recent survey of about 400 food companies. However, the findings generally indicate that companies are taking action now to be FSMA ready—they just might need some help along the way.
Sponsored by SafetyChain Software and The Acheson Group, “2016 FSMA Readiness & Compliance Strategy” surveyed mainly U.S. companies (88% with more than $1 million in revenue) that produce and manufacture food for human consumption.
An effective food safety plan is a fundamental part of FSMA compliance. The majority of participants (80%) are either currently updating their food safety plans or plan on doing so this year. Conducting a gap analysis is a common way to assess the effectiveness of a food safety plan: 84% of respondents plan to conduct a gap analysis, have one in progress, or have already completed the exercise. More than half of these companies are tackling it using internal resources, and 29% are seeking expertise outside their organization.
85% of companies surveyed know which rules apply to their company. Survey sponsored by SafetyChain and The Acheson Group
Documentation plays a large role in meeting FSMA requirements, and in the event of an audit, companies must be able to produce records within 24 hours. The good news is that 76% of companies say they can retrieve records required by FDA within this time span, but 22% are still unsure. Half of the organizations anticipate being audit ready on day one of FSMA enactment. And despite a push to migrate to electronic documentation, most of the companies surveyed (84%) still keep both paper and electronic records; only 3% keep strictly electronic documents.
Companies indicate that they’re using technology to aid in FSMA compliance.
The survey authors concluded that companies still need more information on how they can meet FSMA requirements, what resources are available, and how certain systems can help. In addition, they indicated that corporate executives must play a larger role in implementing compliance.
FDA has finalized the FSMA rule Sanitary Transportation of Human and Animal Food. The rule establishes sanitary requirements for shippers, loaders, motor and rail vehicle carriers, and receivers involved in transporting human and animal food. The rule does not apply to exporters that ship food through the United States.
“Consumers deserve a safe food supply and this final rule will help to ensure that all those involved in the farm-to-fork continuum are doing their part to ensure that the food products that arrive in our grocery stores are safe to eat,” said Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine in an agency press release.
The sanitary transportation rule puts forth requirements for the following:
Vehicles and transportation equipment, including design and maintenance
Transportation operations, including temperature control, preventing contamination between ready-to-eat food and raw food
Training of carrier personnel
Record maintenance, including written procedures, agreements and training
Those exempt from the rule include:
Food transportation shippers, receivers and carriers with less than $500,000 in annual revenue
Farms that perform transportation
Transport of compressed food gases and food contact substances
Transport of live food animals
Transport of human food byproducts for use as animal food without additional processing
Businesses must comply with the regulation one year following publication; smaller businesses (those with fewer than 500 employees and motor carriers with less than $27.5 million in annual receipts) have two years to comply.
Additional information is available on FDA’s website.
How are FDA investigators taking a new approach with FSMA? WATCH THE VIDEO
FDA announced today that it has submitted the final FSMA rule, Sanitary Transportation of Human and Animal Food, to the Federal Register for publication. It can take a few days for the documents to be available, so stay tuned for updates from Food Safety Tech once the final rule is available.
This article was part of our April Fool’s edition. 15% of poll participants guessed that this story was fake. Nope! It’s true.
A group of organizations have united to file a lawsuit against FDA following the agency’s approval of the first-ever genetically engineered (GE) salmon. The salmon is made with the DNA from Atlantic salmon, Pacific king salmon and Arctic ocean eelpout.
Represented by counsel from the Center for Food Safety and Earthjustice, the coalition is challenging FDA’s claim to have authority to approve and regulate GE animals as “animal drugs” under the FD&C Act. The group is upset that approval of GE salmon also paves the way for the entrance of additional GE fish, shellfish and animals including chickens, cows, goats, pigs, sheep and rabbits into the market.
They are also concerned about the fact that accidental release of man-made salmon into the environment could threaten the natural population via mating or introduce new diseases. “Once they escape, you can’t put these transgenic fish back in the bag. They’re manufactured to outgrow wild salmon, and if they cross-breed, it could have irreversible impacts on the natural world,” said Dune Lankard, a salmon fisherman and the Center for Biological Diversity’s Alaska representative, in a press release. “This kind of dangerous tinkering could easily morph into a disaster for wild salmon that will be impossible to undo.”
The GE salmon has been developed by Massachusetts-based AquaBounty Technologies, Inc. On its website, the company states that if salmon escape into the wild, there should not be an issue, because the fish are sterile. “Fish grown from AquAdvantage eggs are all female and sterile, making it impossible for them to breed among themselves and with other salmon. In addition, FDA approval requires them to be grown in physically contained land-based systems, further reducing any potential impact on wild populations.”
Golden Gate Salmon Association executive director John McManus, disagrees. “There’s never been a farmed salmon that hasn’t eventually escaped into the natural environment,” he stated. “Why should we believe that long term, these frankenfish won’t be the same?”
This article was part of our April Fool’s special edition. While the information about the Interpol seizure is indeed factual, we made up the new detection method (EFAS). 35% of poll participants were correct in guessing that this was the article that contained false information.
This week Interpol-Europol announced its largest-ever seizure of fake foods and beverages across 57 countries over a four-month time period. In total, Operation Opson V seized 10,000 tones and 1 million liters of food products between November 2015 and February 2016, with the following topping the list:
Fertilizer-contaminated sugar from Khartoum, Sudan (nearly 9 tons)
Olives painted with copper sulphate solutions to enhance color (85+ tons)
“Today’s rising food prices and the global nature of the food chain offer the opportunity for criminals to sell counterfeit and substandard food in a multi-billion criminal industry which can pose serious potential health risks to unsuspecting customers. The complexity and scale of this fraud means cooperation needs to happen across borders with a multi-agency approach,” said Chris Vansteenkiste, cluster manager of the Intellectual Property Crime Team at Europol in an agency release.
Other seized products worthy of note include:
Chicken intestines preserved in formalin from Indonesia (70 kg)
Monkey meat from Belgium
Locusts (11 kg) and caterpillars (20 kg) from France
Fake whiskey from Zambia (1300 bottles)
Tilapia unfit for human consumption imported to Togo (24 tons)
Honey from Australia (450 kg)
And for the false information:
At a recent conference for food laboratory professionals, Gavin Rosenberg, Ph.D., discussed an emerging analytical method that could be game changing in detecting adulterated products in the field. Using electrostatic fluorescence absorbance spectroscopy (EFAS), Rosenberg’s lab has been able to probe the chemical composition of products, from liquids to bulk and high-moisture foods, while simultaneously assessing concentration in products such as meat and even spices. The rapid and portable method is also highly sensitive and can provide trace detection of pathogens, dyes, antibiotics and pesticides within 60 seconds.
“While still in the research stage, EFAS has been utilized in several studies and has successfully been shown to detect contaminants as well as ingredients that are frequently added to adulterate food products,” said Rosenberg. He indicated that his team will pursue initial applications of the product to identify adulteration of olive oil (nearly 70% of olive oil is adulterated or diluted) and ground beef, specifically in the European and Asian markets.
This article was part of our April Fool’s edition. 49% of poll participants thought this story was fake. Alas, it’s true! Better luck next time.
If you plan on visiting Switzerland any time soon, take your beverages without ice. Why? A recent study has found that more than 25% of ice cubes used in bars and restaurants in Switzerland contain bacteria, including E. coli, pseudomonas and enterococci. According to SonntagsBlick, the publication that released the information, the bacteria is an indication of unsanitary ice cube production, namely due to the machines being kept in basements and cellars and not being properly cleaned or maintained.
“Abroad you are always careful with ice,” Sara Stalder, director of a consumer protection group told SonntagsBlick. “But in Switzerland one would never expect one in four ice cubes to exceed legal limits.” Despite the fact that the ice cubes surpassed legal limits in terms of the presence of bacteria, the amount of bacteria isn’t enough to be dangerous to humans.
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