Tag Archives: FSMA

Contamination, Adulteration Remain Highest Priority

By Maria Fontanazza
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Increased media attention and consumer awareness of verifying ingredients, detecting allergens and effectively tracing the source of outbreaks has placed much higher scrutiny on food processors and manufacturers. With the anticipated FSMA final rule on intention adulteration (Focused Mitigation Strategies to Product Food Against Intentional Adulteration) expected in late spring, having the ability to effectively detect and address product contamination and adulteration will be of significant importance to manufacturers. In preparation for the upcoming Food Labs Conference March 7–8, Food Safety Tech sat down with Craig Schwandt, Ph.D., director of industrial services at McCrone Associates, to learn how contamination is currently affecting food companies and what they should be doing to protect their products and ensure consumer safety.

Craig Schwandt will be presenting “Contaminant Particle Identification: Establishing Provenance and Complying with FSMA” at this year’s Food Labs Conference | March 7–8 | LEARN MOREFood Safety Tech: What are the big issues facing the food industry related to product contamination?

Craig Schwandt: I think the biggest issue facing the food safety industry is realizing that FSMA, in its final ruling, comes with requirements to ensure food safety from farm to table. In the past, many [ingredients] were GRAs, or generally recognized as safe, so when there was a contaminant, [food companies] had a lot of liberty in disposing of the batch and weren’t too concerned about where it came from.

FSMA is going to require that [food companies] keep records of what contaminants are found, how they address it and whether it’s a recurring problem, and [that they] have a procedure in place to track back and [conduct] forensic analysis. In the analytical services industry we call it investigational analysis, which is a description of what actually takes place for ascertaining what the contaminant is and how it got there. That information is provided to clients so they can track back in their production process—all the way to the raw materials and then ascertain where the contaminants came from in that production chain.

The big challenge will be in recognizing that they have to start keeping records and then actually doing the investigation to determine what contaminants are there and determine where they’re coming in.

Craig Schwandt_McCrone Associates
Craig Schwandt, Ph.D., McCrone Associates

FST: Are companies taking the right steps to detect and identify contaminants in food?

Schwandt: Some of them do and some don’t.  At last year’s Institute of Food Technologist’s conference in Chicago, there was a session on FSMA in which there were representatives from FDA, the Grocery Manufacturers Association and a major food company.  I was a little bit shocked by the food company’s position.  They felt they didn’t need to take all of the steps required by FSMA because they dealt directly with producers from all over the world.  They felt removing intermediaries from their supply chain sufficiently protected their products from adulteration. This seems to be oversimplifying the production and supply chain process. Even though they may directly deal with farmers, there’s still opportunity from the time food stuff is harvested to being dried, placed in containers, and shipped from overseas to the U.S.—there are several steps where unintentional contaminants can arise. So to say they didn’t need to look at the potential for contamination because they dealt directly [with farmers] is a bit oversimplified.  I think this perspective typifies some of the industry’s viewpoint at the moment.

The Foreign Supplier Verification Program specifically addresses this concern.  Even companies that deal directly with producers and supplies in the country of the product’s origin will be required to demonstrate that they tested it and verified it as uncontaminated.

The understanding and recognition by suppliers of these new regulations is the biggest issue facing the food industry right now—especially now that the final rulings have been issued and we’re in the grace period before compliance with the regulation is required.

FST: What technologies are helping in the effort to fight product adulteration, especially as it relates to FSMA compliance?

Schwandt: Handheld instrumentation is making headway at identifying, at a gross scale, screening capabilities—handheld x-ray fluorescence instrumentation and handheld infrared spectroscopy, to identify things at the bulk level. Mass spectrometry methods and chromatography are exceptional at their ability to do really fast general screening for chemical adulterants. I think many of the food laboratories and food companies have in-house laboratories and screen in that general way.

In terms of some of the solid phase contaminants, I think there’s a lack of in-house capability at the moment where one can use simpler [methods] like optical microscopy and another microscopy-based methods to identify the physical solid phase contaminants.

A good example is the use of magnetometers.  Many companies use large-scale process line magnetometers to highlight the presence of metal pieces in their product. A magnetometer tells you that there are metal contaminants in your product, it does not provide a specific alloy identification.  Whether one needs to go further to use additional methods and actually ascertain the composition of the alloy, is the question.  That’s a new requirement—to identify what it is and then to try and assess where in the process it may have occurred. Using a microscopy-based method is advantageous because metal pieces are easily isolated and identified. Once food industry clients have an idea of what the alloy is, they can compare it to the metal alloys that make up their machinery along the way, whether it’s packaging or sorting machinery, [and] essentially establish where the particles enter into the food process.

GFSI and the Road to FSMA

By Maria Fontanazza
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Many companies certified to a GFSI scheme appear to have a leg up on preparing for FSMA, especially in the area of documentation and record keeping. During a quick chat with Food Safety Tech, Bob Butcher, group operations manager at Ipswich Shellfish Company, explained how GFSI has helped the seafood processor get ready for FSMA. Do you agree? Sound off in the comments section.

Food Safety Tech: What common challenges do companies experience when managing compliance with a GFSI scheme?

Bob Butcher: Every time there’s a new regulation it’s a matter of understanding how that regulation applies to us. The seafood industry has been regulated by FDA mandatory HACCP requirements for years now. Some of the items that are covered under FSMA have already been covered by the seafood regulations. Our facilities have also undergone third-party audits for a number of years and three are already SQF certified—so in order to meet those certifications, we comply with all the FSMA requirements at this point. That being said, there’s always a challenge or opportunity to make sure we comply with all the regulations and above that, make sure that the quality [of the product] we send to our customers meets both their standards and our standards.

FST: Has being certified to a GFSI scheme helped your company better prepare for FSMA compliance?

Butcher: Because we’re SQF certified and are meeting most of the requirements of the seafood industry, we’re well ahead of meeting FSMA requirements. Maintaining the GFSI requirements put us in great shape for FSMA.

GFSI covers so many areas. [Regarding] vendor compliance, we critically examine the seafood that comes in every day and it’s a very perishable commodity, but every plant is a little different in the talent they have and the number of people. We’ve been able to focus on making sure that the product meets the same criteria at each of the facilities no matter who is receiving it and documenting it accordingly. And whether [complying with] GFSI or FSMA, documentation is important.

We’ve gone the extra step in automating so we can better track how each of the plants and suppliers are performing. We started rolling it out at one plant two years ago and then extended it to all plants. All of our facilities have been under it for a year.  

I think more and more companies are acknowledging the need to automate. With paper forms it’s difficult to make sure the employee has the correct and latest version, and the filing and recovery of that document [is difficult]. If it’s digital, you can get your hands on the latest version any time you want. Plus, you can analyze digital information and easily look for trends.

However, the seafood industry isn’t like a number of other industries—the margins are low, and so cost is absolutely a factor. If it’s a single facility, having paper forms, depending on the extent of the operation, may be acceptable. But if you get into multiple locations, it’s a whole different challenge all together.

FST: What are the broader issues that the seafood industry is currently facing?

Butcher: Supply and sustainability—making sure that you have a handle on the sustainability of the species and are able to explain that to your customers. That ties into record keeping—getting the right product, when it’s an MSC [Marine Stewardship Council] or ASC [Aquaculture Stewardship Council] chain of custody, or whether it’s having the right relationship with the vendors so you know your source. Cost is a concern, along with quality and inventory levels.

There are a lot of very small companies and a lot of them aren’t GFSI certified. A lot of them don’t even have any type of third-party audits, so I’m not sure how ready they are. It’s always a challenge for a small company to get up to speed.

FST: Does compliance with a GFSI scheme help address these issues to some extent?

Butcher: As we started working on GFSI or FSMA, and even HACCP many years ago, we started looking at products differently. You’re documenting more and gaining information—and once you have that information, you can focus on cost factors and inventory. So from that standpoint, it has been very helpful.  At this point, we’re SQF Level, and we plan to go Level 3, which involves more quality parameters and certification. That will greatly impact the product and the profitability as well.

FST: What are your tips for companies in terms of being audit ready?

Butcher: The software program we use helps us maintain our facilities to be as audit ready as we can from a documentation standpoint. With SQF there will be unannounced audits, and it’s always been FDA’s practice or the state inspector’s practice to pop in anyway, so you have to be ready for that inspection at any time. The whole principle of HACCP is to make sure you’re documenting what you’re doing. And whether it’s an auditor or an inspector, they’re coming in at any time and can look at records for the past two years, so you should be in compliance and be able to prove that.

Gary Smith, Eurofins’ Food Safety Systems

FSMA Mandates Employee Training. Are You Prepared?

By Maria Fontanazza
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Gary Smith, Eurofins’ Food Safety Systems
Gary Smith, Eurofins’ Food Safety Systems
Gary Smith, director of food safety, Eurofins Scientific

Training plays a huge role in the effective implementation of FSMA. The preventive controls for human food final rule calls out areas in which training is now obligatory, namely ensuring that employees involved in the manufacturing, processing, packaging and holding of food are properly educated on food safety and food hygiene (mandated under Current Good Manufacturing Practices). FDA has initiated an extensive training strategy, part of which includes establishing a National Coordination Center (the agency awarded a $600,000 grant to the International Food Protection Training Institute in October), along with several collaborative efforts with other federal agencies and industry partners.

Although many food companies have been conducting training as part of their standard procedures, preparing employees for the implementation phase of FSMA may be more complicated than they anticipated. In a Q&A with Food Safety Tech, Gary Smith, director of food safety services at Eurofins Scientific, shares insights on some of the hurdles that industry is encountering (including manufacturers in the animal food arena) related to training and FSMA compliance.

Food Safety Tech: How has FSMA changed the landscape of employee training?

Gary Smith: There are a couple of updates that are very important to note for the industries as a whole. First, employee training is now mandatory for both human food facilities and, probably even more importantly, animal food facilities. Many of the human food folks may have been asked by customers or by other entities via corporate internal procedures to do training of employees and to have a training program in place. For a lot of the pet food and animal feed manufacturers, having a comprehensive training program for all employees is significantly different than what has been requested and expected of them in the past.

Second, the preventive controls rule for both human food and animal food specifically requires that animal food and human food manufacturers conduct training of all their employees on at least food safety and food hygiene topics. Now, what does that mean? We’re interpreting that to mean basic GMPs as well as common food safety hazards. Realistically, this will probably be a 30 to 60-minute training session in which everyone in the facility will have to attend, and FDA doesn’t state specifically that it has to be done more than at least once. There is no frequency for re-training. However, once the compliance dates are effective, it’s mandatory that the training has been completed. This is a new concept for the majority of industry who may have had corporate training programs or customer-driven training programs, but never a mandated regulatory requirement for training.

FST: What challenges do food companies face in ensuring that employees are prepared for the implementation phase?

Smith: There’s the challenge of putting together the training, which, in the big picture of FSMA, shouldn’t be that big of a deal.

Some of the biggest challenges companies face (especially in trying to get ahead of the game and be proactive) is the identification of the preventive controls qualified individual. Is it an internal person? Is it a consultant? Do they have to go through a specific training class? The answer is yes, they do. How do they deal with foreign suppliers? A lot of folks are really confused about the concept of the Foreign Supplier Verification Program rule and what it means. Do they need to audit [their suppliers]? Do they need to be GFSI certified? There are a lot of questions concerning the importation of ingredients from outside the United States—what’s the requirement? This is probably the biggest area in which people seek clarity.

Another [challenge] is internal supplier approval, because the new rule talks about supplier approval as one of the preventive controls that has to be in place. Again, who can do those audits? When do we have to conduct an audit? What does the audit have to cover? A lot of folks are struggling with this area as well.

The last challenge: A lot of folks have HACCP, whether they are human or animal food manufacturers, and this has been required or requested by customers for a while. But how do we transition from having a HACCP plan to a food safety plan that meets the preventive control requirements in addition to the HACCP requirements? How do I build in allergen management as a preventive control? How do I build in sanitation as a preventive control? How do I build in supplier approval as a preventive control? There are a lot of questions surrounding whether companies should scrap their HACCP plan and start over, or whether they have to add on to it.

FST: Eurofins offers an extensive training schedule for the first half of 2016. How do these offerings play into FSMA’s compliance requirements?

Smith: Eurofins is now offering the highly anticipated 2.5-day training created by the FDA’s Food Safety Preventive Controls Alliance (FSPCA). The standardized curriculum is designed to meet the training requirements under Title 21 Code of Federal Regulations Part 117.115 for the “preventive control qualified individual” who conducts certain Food Safety Plan activities. In addition, Eurofins offers core courses such as Environmental Monitoring, Internal Food Safety Auditing and HACCP to help support the development and implementation of a company’s food safety plan.

FDA

Part of FDA FY 2017 Budget Request to Hold Food Importers Accountable

By Food Safety Tech Staff
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FDA

UPDATE 2/22/2016 – According to an updated FDA alert, the FY2017 budget requests include an increase of $25.3 million of new budget authority to implement FSMA, with FDA focusing on two main areas:

  • National Integrated Food Safety System  ($11.3 million). Support state capacity to implement the produce safety rule via education and technical assistance to farmers and on‑going compliance support and oversight
  • New Import Safety Systems ($14.0 million). Implementing the FSVP rule, which makes importers responsible for ensuring that the foods they bring in from other countries are produced in a manner that is consistent with U.S. food safety standards

– END UPDATE –

FDA wants 8% more money for its FY 2017 budget, requesting a total of $5.1 billion.  Part of this $14.6 million net increase in budget authority will go toward FSMA implementation. Specifically related to food safety, FDA is asking for more than $18.4 million in budget authority and more than $193.2 million in user fees. According to an FDA press release, the agency will be using the budget to support federal and state efforts related to enforcing safety standards on produce farms. In addition, FDA wants to use the money “to hold importers accountable for verifying that imported food meets U.S. safety standards, as well as conduct food safety audits of foreign food facilities”.

FDA is also requesting more than $3 million for building and facilities funding, and more than $600,000 to support other areas to improve the agency’s infrastructure. The fiscal request is for October 1, 2016 through September 30, 2017.

Audit

The Multi-Step Process of Third-Party Accreditation

By Charles Breen
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Audit

The FSMA Third Party Accreditation (TPA) final rule was published in the Federal Register in final form on November 27, 2015. Although TPA is not limited to imported food, its primary use will most likely be for food imports. TPA offers foreign food facilities and food importers a way to show FDA that the items coming to the United States meet federal food safety requirements.

An acceptable audit by a certified auditor is the only way an importer can take advantage of another FDA program, the Voluntary Qualified Importer Program (VQIP), which offers expedited review and entry of food. If FDA deems it necessary, the agency can also require certified audits for the import of specific foods.

The TPA process requires a number of administrative steps by FDA and non-FDA entities before the first third-party inspection is made. The four major steps are:

  • FDA is responsible for officially recognizing accreditation bodies.
  • An officially recognized accreditation body will accredit third-party certification bodies.
  • The accredited third-party certification body will certify third-party auditors.
  • The certified auditors will conduct consultative and regulatory audits of food facilities.

If FDA does not find an applicant that it can officially recognize as an accreditation body within two years, it may directly accredit third-party certification bodies.

In order to recognize an accreditation body, FDA must review an applicant’s legal authority, competency, capacity, conflict-of-interest safeguards, quality assurance and record procedures. By using an already existing framework familiar to industry, accreditation bodies and certification bodies will be allowed to use documentation of their conformance with the International Organization for Standardization and the International Electrotechnical Commission (ISO/IEC) standards, supplemented if necessary, in meeting program requirements under this rule. An official recognition of an accreditation body is granted for up to five years.

FDA is authorized to recognize a foreign government/agency or a private third party as an accreditation body under TPA.

Recognized accreditation bodies under TPA will be required to:

  • Evaluate potential third-party certification bodies for accreditation, including observing representative samples of the prospective certification body’s work
  • Monitor performance of the third-party certification bodies it has accredited, including periodical on-site observations, and notifying the FDA of any change in, or withdrawal of, accreditations it has granted
  • Self-evaluate and correct any problems in their own performance
  • Submit monitoring and self-assessment reports and other notifications to the FDA
  • Maintain and provide the FDA access to records required to be kept under the program

Once accredited, third-party certification bodies under TPA are required to perform unannounced facility audits, and to notify the FDA if a condition is found that could cause or contribute to a serious risk to public health.

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Dollar

FDA Makes FSMA Education and Training Available

By Food Safety Tech Staff
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Dollar

As part of FDA’s FSMA training vision, the agency has announced two funding opportunities aimed at providing outreach, education and training on the FSMA preventive controls rules.

The Native American Tribes Outreach, Education and Training cooperative agreement will provide up to $750,000 annually for three years. “FDA anticipates that federally recognized tribes will need food safety education and training that addresses the regulatory requirements of the applicable FSMA rules and also encompasses specific cultural practices associated with produce farming and food manufacturing/processing within tribes relevant to their status as sovereign nations,” according to an FDA release.

The Local Food Producer Outreach, Education, and Training agreement will award local food producers $1.5 million this fiscal year with the potential for two more years if federal funds are available. It aims to assist small and mid-size producers/processors with particular practices related to their scale of production and management practices. The agreement will focus on those involved in local food systems while considering “account diversified, sustainable, organic and identity-preserved agricultural production and processing.”

TraQtion dashboard

New Software Warns of Out-of-Compliance Suppliers and Products

By Food Safety Tech Staff
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TraQtion dashboard
TraQtion dashboard
Screenshot of TraQtion dashboard. Click to enlarge (Courtesy of NSF International)

TraQtion has announced new software that is designed to help companies better manage supply chain risks. By scanning, evaluating and interpreting data, the upgraded cloud-based software is able to anticipate potential issues and whether corrective measure must be taken immediately, and alerts clients to suppliers, products and sites that pose a higher risk. Its intelligent compliance engine runs an algorithm in the background to provide visibility to problem areas and prioritizes responses across a company’s locations accordingly. A product inspection module automatically identifies in-spec and out-of-spec products through testing and inspection. A dashboard gives users an overview of the company’s quality and compliance program, and uses a color-coding system to rate suppliers, products and sites.

TraQtion is a wholly owned subsidiary of NSF International.

Ryan Mead, Focus-Works
FST Soapbox

8 Reasons to Go Digital 2016

By Ryan Mead
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Ryan Mead, Focus-Works

This year, more food manufacturing companies than ever are actively seeking software solutions for food safety and quality management. The majority of food businesses still collect food safety records using pen and paper, which is a time-consuming process and is far from reliable. Fortunately, food safety software is drastically changing the way HACCP and other QA/QC data becomes collected and stored. The following are some reasons food safety software is a must-have in 2016.

1.     Overwhelming Amount of Paperwork

Many employees at food manufacturing facilities—whether meats, baked goods, or beverages—still rely on pen and paper forms, checklists, and log books to manage their food safety operations. This allows operator errors and omissions to happen far too easily. Even well managed systems that use paperwork can reach a tipping point. Quality managers already have a big enough workload, and piling on the job of verifying all paperwork only increases the chances of a failure.

2.     Constant Change in Food Safety Standards

FSMA, the most sweeping reform of food safety laws in more than 70 years, was signed into law in 2011. While most food manufacturers have only been mandated to register, the time of more strict enforcement is coming. Global standards for food safety such as, SQF and BRC, fall within this generation of compliance. The necessities of these programs are constantly changing, becoming stricter and introducing new categories of requirements. Food safety software offers an effective way to deal with the ever-shifting landscape by providing evolving solutions managed by a software provider.

3.     Consumer Confidence

Consumer expect a safe and healthy product, and as such, a company must instill a feeling of confidence. When a product is expected to provide nutrition, energy and enjoyment any incidence of foodborne illness will only prevent future confidence in the product. In addition, the consumer is likely to spread the news among peers about how he or she became sick. It is the duty of the food company to do everything in its power to process, store and prepare food in the safest way possible. That process starts with ensuring a higher level of reliability in a food safety program, which can be achieved by using food safety software.

4.     Economics

No food company wants to deal with the hassle of a lawsuit from an outbreak or recall. These events can cost thousands, if not millions, of dollars in damages and  cause serious loss to a company of any size. Although many companies carry insurance for these occurrences, there still is the loss of sale from consumer mistrust. Investing in software can help companies increase profits by improving efficiencies. For example, companies can measure these efficiencies not only from labor savings but also from significant savings in paper and toner (i.e., saving $2000–$5000 a year).

5.     Operator Error and Omission

In an age in which documentation is becoming digitalized, food safety requirements are becoming more tedious. Even the smallest employee error can have massive repercussions. The cost of added staff is one thing, but the reliability of the data and adherence to schedule is another. Relying on inaccurate data collection may result in a recall or damage to a company’s brand.

Pencil whipping (faking paperwork) occurs for a variety of reasons, from employees taking short cuts to avoidance of writing down out-of-spec data. Manual record keeping has proven over time to be prone to errors. Employees, bored with the distraction of measuring and writing down dough or batch temperatures, piece weights or metal detector tests, and fill out forms with moot numbers just to complete the form.

6.     Monitoring and Notification

Being aware of control points is another way in which companies can avoid disaster. Food safety software can give companies the ability to monitor oven and freezer temperatures, metal detectors, tests or any other control point in real time. This capability also alerts users when a control point is out of deviation (doing so at a glance), along with sending custom notifications, allowing a plant to quickly address problems while simultaneously properly documenting the issue.

7.     Audits: Go from Stressful to Easy

An upcoming audit can be stressful for any company, involving numerous people who are gathering an abundance of documentation. With food safety software there is no reason to scramble to get documentation together or waste precious time preparing it. Auditors can simply view a company’s software for any requested documentation. For example, a company can produce random temperature logs, metal detector times, SSOPs, customer complaints and a variety of other documentation in just a few clicks.

8.     The Technology Is Available

One of the reasons why so many companies continue to use paper and Excel-based systems today is because they are unaware of the abilities and functionality available to them. After completing the formidable task of attaining a new-found level of compliance, some companies may find it daunting to continue to go to the next step of converting to a computerized system. Finding user-friendly food safety software that has good customer support, as well as solutions that are customized to user needs, is not necessarily easy. The key is to find software and a supplier that can provide the right solution for your company and food safety program, whether it’s HACCP, BRC or SQF, and ensure that it fits within an acceptable budget. Consider not only the initial cost but also the cost of implementation. What resources will be required? How much can the supplier help with implementation? Having the right answers and the true costs will assist you in arriving at the correct solution.

Fritz Kriete
FST Soapbox

5 Ways Food Companies Can Protect Themselves And Customers

By Fritz Kriete
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Fritz Kriete

While illnesses linked to Chipotle restaurants are grabbing headlines, the federal government recently took steps to improve how manufacturers and packagers process and handle food. Last year FDA released several final FSMA rules, giving food companies a roadmap for ensuring food safety. The proactive approach of the regulations can help companies avoid the hazards that lead to disease and allergen contaminations, and even legal troubles. Indeed, unsafe food handling can carry costly consequences from both a financial standpoint as well as in lives lost or harmed.

In 2011, the good intentions of a family-owned cantaloupe company produced tragic results. The company, seeking more natural melons, followed a consultant’s advice and discontinued the chlorine rinse used to wash off contaminants. A Listeria outbreak followed, killing 33 people and hospitalizing 147 more. Although prosecution is rare in foodborne disease outbreaks, the company owners were sentenced to probation, home detention, community service, and $150,000 each in restitution.

A more egregious case occurred in September 2015, when the former CEO of the Peanut Corporation of America was convicted of knowingly shipping Salmonella-tainted peanut butter, which had caused an outbreak that killed nine people and sickened hundreds more. Stewart Parnell was sentenced to 28 years in federal prison.

The new regulations require companies to undertake hazard analyses of their production, along with remedial steps. This scrutiny leads to the creation of a written plan that details the controls to prevent contamination and establish a schedule for periodic testing. This analysis and control system is called the Hazard Analysis Critical Control Point, or HACCP.

Adherence to regulations doesn’t necessarily protect a company from liability, but not adhering can sound a company’s death knell when there’s a problem. The following are five ways in which companies can protect themselves:

  1. Put food safety first. The company culture must revolve around it. The message that the HACCP plan is to be followed must be relayed to all levels of the organization. Otherwise, companies can face severe consequences, based on the question, “Did the company behave badly enough to face strong punitive damages?”
  2. Concentrate on internal communications. In many cases, food recalls happen because of a breakdown in the communication process.
  3. Hire accredited consultants. Make sure that your consultants are qualified and have been accredited by an appropriate body such as the International HACCP Alliance or The Seafood HACCP Alliance.
  4. Don’t overlook supplied products. Suppliers should adhere to strict contamination-prevention protocols, but don’t assume they follow guidelines completely or have flawless processes.  Your contracts with them should require that they periodically audit their facilities and share the audit results with you.
  5. Label clearly. Packaging language might state that a product is manufactured in facilities that also process allergens such as peanuts and tree nuts. These types of warnings allow consumers to make up their own minds. It is also a reminder that HACCP plans must address prevention of cross-contamination (i.e., putting cleaning protocols in place if products with and without allergens are processed on the same equipment).

Many problems involve internal slip-ups or problems with supplied ingredients that allow contaminated food to reach consumers. If the contamination becomes known—and it often is not, when victims don’t equate their illnesses with tainted food—the businesses involved often face strict liability, meaning they carry some blame even if they didn’t act in a negligent manner and cause the problem directly.

Keep in mind that liability isn’t the only consequence of non-compliance. A recall or outbreak can damage the reputation of the company and the product. The cantaloupe tragedy sent sales of the melons plummeting, even in states not linked to the outbreak.

To minimize the hit on sales, a recall team should be in place, with a plan modeled on crisis management principles. Team members should come from all divisions of the company, including transportation and distribution to track down products, and communications to manage messaging. Legal counsel should be on board to advise on the ramifications.

When it comes to foodborne outbreaks, it’s a matter of taking classic prevention and preparation steps. Do everything you can to keep it from happening, but be ready just in case it does.

FSMA, Food Safety Tech, FDA

Certified to FSSC 22000? You’re Ready for FSMA

By Maria Fontanazza
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FSMA, Food Safety Tech, FDA

If my company is GFSI-certified, is it also FSMA compliant? The answer is: With shared goals of producing safe food, coordinating preventive measures and ensuring continuous improvement, if your company is FSSC 22000 certified, you’re well on the road to FSMA compliance, according to Jacqueline Southee, Ph.D., U.S. Liaison, FSSC 22000.  Southee discussed several areas in which FSSC 22000 aligns with FSMA as part of a recent Leadership Series, “GFSI in the Age of FSMA”.

Supply Chain Visibility

FSSC 22000 is applicable to all aspects of the supply chain and requires interactive communication (all of which must be documented), from the downstream level in ensuring raw materials and suppliers meet requirements of ISO 22000 framework to communication with customers and suppliers to verify and control hazards.

FSMA controls the hazard of food within the United States, says Southee, whereas GFSI certification is a global initiative, thereby extending supply chain visibility to foreign suppliers.

The Food Safety Plan

There has been much discussion surrounding building a FSMA-ready food safety plan and the migration from HACCP to HARPC. “HARPC can be referred to as HACCP with preventive controls,” says Southee. FSSC 22000 provides a flexible yet robust approach in a framework that is applicable to all situations (i.e., different manufacturers have different issues, such as producing ice cream versus baked goods). Rather than being prescriptive, the prerequisite program has the flexibility to apply to a particular situation. In addition, validation, verification, monitoring and documentation are an inherent part of the ISO 22000 approach and the FSSC 22000 certification.

FSSC 22000 serves as an effective tool in preparing companies for FSMA compliance. “We’re not a regulatory system; FDA has that domain,” says Southee. “They’re the ones that carry the responsibility of meeting those regulations. We work with everyone…to do the best job we can.”

Audit Readiness

Being audit ready all the time is a key part of preparing for FSMA. FSSC 22000 certifies a food safety management system (a three-year certification cycle) and requires internal audits of company performance, along with helping companies ensure that their records are organized at all times. The goal is to install a management system that enables constant monitoring, reevaluation and assessment as part of an ongoing process of keeping food safe, according to Southee. “If you’re certified and have an effective ongoing management system, unannounced audits won’t be an issue,” she says.

Food Safety Culture

FSSC 22000 and ISO 22000 provide a strong foundation for building food safety culture. ISO 22000 requires proof of management commitment to the food safety process, along with accountability, and for management to make resources available to see the food safety process through. “We agree that culture has to come from the top,” says Southee. “The personnel have to see that management is committed, and the culture will come from that commitment.” It also requires constant communication, up and down the supply chain as well as internally. This includes involving all employees and making sure that they know what they’re doing (i.e., training). “Everyone needs to know they’re valued and important, and how their function contributes to the function of safe food,” says Southee.

FSMA Alignment and Gap Analysis

There are sure to be some gaps when it comes to FSSC 22000 and FSMA. FSSC 22000 has commissioned a gap analysis to compare the preventive controls for human and animal food rules with the GFSI scheme and will add addendums as needed. Areas of review include a requirement to include food fraud into the hazard analysis and a review of unannounced audit protocol.