Tag Archives: FSMA

Counting Food Laboratories

By Robin Stombler
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What We Think We Know

Food laboratories in the United States may voluntarily choose to become accredited to an international standard known as ISO/IEC 17025:2005. This standard outlines the general requirements for the competence of testing laboratories.

More recently, the FDA issued a final rule on the Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (Third-Party rule). Effective January 26, 2016, this final rule states that “for a regulatory audit, (when) sampling and analysis is conducted, the accredited third-party certification body must use a laboratory accredited in accordance with ISO/IEC 17025:2005 or another laboratory accreditation standard that provides at least a similar level of assurance in the validity and reliability of sampling methodologies, analytical methodologies, and analytical results.”  In short, for a segment of food laboratories, accreditation has become a necessary credential. At present, it remains a voluntary activity for most food laboratories.

There are accreditation bodies that accredit food laboratories to the ISO/IEC 17025 standard. The major accreditation bodies report on their individual websites which U.S. food laboratories are accredited under their watch.

To find the number of accredited laboratories, a quick search of the websites of four major food laboratory accreditation bodies, A2LA (American Association for Laboratory Accreditation), AIHA-LAP (American Industrial Hygiene Association – Laboratory Accreditation Programs, LLC), ANAB (American National Standards Institute-American Society for Quality), and PJLA (Perry Johnson Laboratory Accreditation) was performed on February 24, 2016. It yielded some debatable results. Here are some of the reasons for the skepticism:

  • The numbers are self-posted to individual websites. The frequency with which these websites are reviewed or updated is unknown.
  • Sites list both domestic and international laboratories. While foreign addresses were excluded from the count, those laboratories could perform testing for U.S. entities.
  • It can be difficult to separate the names of laboratories performing testing on human food versus animal feed.
  • There are several ways to duplicate or even exclude numbers. As examples, laboratories may be accredited within a food testing program, but may also be accredited under “biological” and/or “chemical” schemes—or vice versa.
  • In some cases, it is difficult to discern from the listings which laboratories are accredited for food testing versus environmental or pharmaceutical testing.

With all these caveats, the four major laboratory accreditation bodies accredit approximately 300 food laboratories. A2LA captures the lion’s share of this overall number with approximately 200 laboratories.

Let’s move to another source of numbers. A Food Safety News article about food testing and accreditation published in October 2013 states:

But, when it comes to testing our food, experts estimate that less than five percent of the food testing laboratories in the U.S. are accredited according to international standards…

Some believe that FDA will begin requiring accreditation for at least some significant segment of the food testing industry, of which the U.S. has roughly 25,000 laboratories. Whether that’s restricted to third-party labs – numbering roughly 5,000 – or will also include all food manufacturers’ internal labs is yet to be seen.

Using the writer’s sources, simple arithmetic finds 25,000 laboratories multiplied by the estimated 5% accreditation equals roughly 1,250 accredited laboratories in the United States. This, of course, falls far short of the 300 accredited laboratories noted by the major accreditation bodies. This is not to question either the writer’s sources or the websites of the accreditation bodies, but it does highlight an inconsistency in how we account for the laboratories testing our food.

To go a step further, Auburn Health Strategies produced in 2015, a survey of food laboratory directors, technical supervisors and quality assurance managers on the state of food testing. The survey, commissioned by Microbiologics, asked a series of questions, including: “Are the laboratories you use accredited?”  The respondents replied that, for their on-site laboratories, 42% were accredited and 58% were not. For their outside, contract laboratories, 90% of respondents stated that these laboratories were accredited and five percent did not know.

A second question asked: “Some laboratories are accredited to an internationally-recognized standard known as ISO 17025. Is this important to you?”  Approximately 77% of respondents answered affirmatively. Equally telling, 15% said they did not know or were unsure.

ISO 17025

What we do know is that there is not a definitive accounting of food laboratories—accredited or not. This lack of accounting can present very real problems. For example, we do not have a centralized way of determining if a particular laboratory has deficiencies in testing practices or if its accreditation has been revoked. Without knowing where and by whom testing is conducted, we are at a disadvantage in developing nationwide systems for tracking foodborne disease outbreaks and notifying laboratory professionals of emerging pathogens. We most certainly do not know if all food laboratories are following recognized testing methods and standards that affect the food we all consume.

What We Need Now

FSMA includes a provision calling for the establishment of a public registry of accreditation bodies recognized by the Secretary of Health and Human Services. The registry would also contain the laboratories accredited by such recognized organizations. The name and contact information for these laboratories and accreditation bodies would be incorporated into the registry. Rules for the registry have not yet been promulgated by the FDA, but should be. This is a small step toward greater accountability.

FSMA, Food Safety Tech, FDA

FDA Submits Sanitary Transportation Final Rule

By Food Safety Tech Staff
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FSMA, Food Safety Tech, FDA
Syed Hassan of PepsiCo addresses Michael Taylor during FDA Town Hall
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.

In the meantime, find out how the sanitary transportation rule affects employee training: Specific Training Required Under FSMA: A Look at Each Rule

 

Palmer Orlandi, FDA, Food Labs conference

FDA Pushing Proactive, Real-Time Analysis

By Maria Fontanazza
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Palmer Orlandi, FDA, Food Labs conference

Over the past year, FDA has been emphasizing the level of collaboration necessary with industry to drive a more preventive culture of food safety.  Much of these efforts surround closely integrated partnerships between federal, state and local stakeholders, including a larger role that laboratories will play in FSMA implementation.

Palmer Orlandi, FDA, Food Labs conference
“We can’t test our way to food safety. It’s just not possible,” said Orlandi. He added that industry can work together to develop a testing program that leads to safer foods.

There will be greater reliance on the responsibilities and capabilities of laboratories as a result of the proactive movement in finding points of contamination, before they invade the home of the consumer, in real time. With the convergence of more laboratory analysis and the responsibilities that the FSMA regulations warrant, industry will be relying on the establishment of uniform and standardized lab-related processes and policies in order to bring uniformity and trust to the quality of data being generated and shared, according to Palmer Orlandi, Ph.D., acting chief science officer and research director at FDA’s Office of Food and Veterinary Medicine. Orlandi, speaking at the Food Labs Conference last week, said that FDA is moving in this direction. “The oversights we’re mandating moving forward for data sharing, data reporting and data acceptance are completely equivalent across the board,” he said. FDA is working toward providing more transparency in terms of laboratory oversight and how it intends on working with industry.

Within the five published final FSMA rules there is at least some component of lab support that is necessary. The rule that deals the most with lab involvement, especially laboratory accreditation, is the foreign supplier verification program, because the responsibility falls on the importer to assure and verify safety of the commodity, and this requires the submission of laboratory analysis, said Orlandi.

Palmer Orlandi, FDA, Food Safety Consortium
Palmer Orlandi discusses FSMA and laying the groundwork for data acceptance in lab partnerships at the Food Safety Consortium. WATCH NOW

Currently the majority of FDA’s work effort in the laboratory category falls under compliance program driven sampling, with domestic activities (i.e., inspections) and import activities coming in second and third respectively. Moving forward, environmental driven sampling will play a much larger role, as FSMA places greater emphasis on a risk-based approach and finding issues in real time, directly in the environment.

“We don’t want to be the agency that is just is responding to foodborne outbreaks or responding to problems with industry or farms or any of the commodities,” said Orlandi. “We want to work and become less of an enforcement agency and one of a partner so we can stop problems where they may occur. That involves making partners and leveraging our resources.”

FDA is expanding its responsibility for testing and sampling in the area of surveillance, verification (i.e., preventive controls and import controls), and compliance (i.e., removing adulterated products from the market, enforcement actions, and environmental assessment). The agency is taking a risk-based approach to deploying its resources, and where it does not have the capacity it will be relying on partners for assistance. It is also investing more resources in import testing and the criteria that go into accepting data for import testing, and will be preparing guidance for submission of data.

FDA Vs. USDA: Who Regulates What?
FDA Responsibilities USDA Responsibilities
Manufacturers, processers, packers, holders, distributors, food transporters

Growers of fresh fruits and vegetables, tree nuts and sprouts

Dairy products

Plant products and spices

Grain-based products

Seafood (except catfish)

Beverages and bottled water

Food and color additives

Dietary supplements

 Meat

Poultry

Frozen, dried and liquid eggs (FDA regulates whole eggs)

Catfish
FDA tests foods for the presence of pesticides, toxic elements, mycotoxins, chemotherapeutics in seafood, and microbial hazards (bacterial, parasitic, viral)
FDA

No FDA Mandatory Recall Activity in 2015

By Food Safety Tech Staff
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FDA

On Friday FDA released its 2015 Annual Report to Congress on the Use of Mandatory Recall Authority and there was not much news to report.  According to the agency: “In FY 2015, FDA had no mandatory recall activity to report under section 423 of the FD&C Act. As a result, FDA did not issue any public health advisories as described in section 206(f) of FSMA.”

This is the third report of its kind since FSMA was enacted. It is worthy to not that it only deals with recalls themselves, not other agency communication efforts such as public health advisories, which include consumer advisories, warning letters and reports of outbreak investigations.

John Sammon, ParTech
Retail Food Safety Forum

Break the Pencil: Goodbye Paper, Hello Technology

By John Sammon III
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John Sammon, ParTech

With the passage of FSMA, any location that handles food for public consumption must implement Hazard Analysis and Critical Control Points (HACCP) plans to reduce food safety risks across the food chain. Many businesses with multiple locations in the restaurant and retail industries are finding that traditional paper-based methods of record keeping are no longer adequate to comply with the FSMA. By abandoning paper-based systems and adopting cloud-based technology, restaurant and retail locations can embrace and enforce stronger food safety cultures and help eliminate human error.

According to the CDC, each year an estimated 48 million Americans get sick, 128,000 are hospitalized and 3,000 die from foodborne disease.

Why? The process of purchasing, transporting, preparing and serving food heavily revolves around individual human behaviors related to cooking, cleaning, handling and refrigerating food. When employees do not follow the correct processes and procedures, it can lead to accidental food safety issues.

FSMA & HACCP Plans

In an effort to shift from responding to food contamination incidents after the fact to proactively preventing them, the FDA introduced FSMA in 2011. To allow businesses time to adjust to new rules and regulations, the FSMA requirements are implemented in phases, which began in September 2015 and will continue through May 2016.

As part of a larger food safety initiative, FSMA requires any business that handles food for public consumption to implement a HACCP plan. The purpose of the plan and its procedures is to identify potential hazards in any food-related processes where a lapse in attention or failure to complete a task could turn a potential hazard into an actual one.

The three main components of an HACCP plan that are required to be documented are:

  • Hazards: Evaluate potential hazards that exist in the enterprise. For example, how, when and why Salmonella or Listeria could migrate into a finished product
  • Critical Control Points: Identify critical control points where failures could occur, such as when products are moved from preparation to the sales floor
  • Preventative Steps: Establish the preventative steps that must be followed at each critical control point to reduce hazards, for example, interval checks to make sure correct temperatures, whether hot or cold, are consistently maintained

FSMA also mandates a record of food safety compliance to ensure a company follows its HACCP plan. Every location must document all actions, including ongoing monitoring of when a problem was spotted and corrective actions taken. These records, which have traditionally been created and maintained with pen or pencil and paper logs, must be kept for a minimum of two years.

Deli worker checks cold food temperatures using a handheld probe and wireless device. Maintaining proper food temperatures and recording checks for consistency is an important part of HACCP guidelines.
Deli worker checks cold food temperatures using a handheld probe and wireless device. Maintaining proper food temperatures and recording checks for consistency is an important part of HACCP guidelines.

Compliance Challenges

With multiple locations and an ever-changing labor force, it is difficult for companies to be confident that the food they sell is safe and that every employee is acting diligently when it comes to food safety across the entire enterprise.

In a busy restaurant or retail environment with ever-changing customer demands for a variety of different products and services, a food safety culture and plan can unintentionally become compromised.

With local farmers to international food manufacturers supplying fresh, frozen and prepared foods and a variety of workers in contact with each for different reasons, it can be difficult to track food safety procedures.

Add an inefficient, manual, paper-based food safety record-keeping system that does not proactively remind employees to complete tasks or prompt corrective actions when needed, and you are opening the door to potential problems.

It’s Time to Break the Pencil

Companies must implement the highest standards of food safety processes at all levels and locations. Once a food safety culture is defined, it needs to be enforced every day. Employees should be well trained on policies, feel empowered and mandated to behave consistently.

A major part of the solution is abandoning traditional pen or pencil and paper-based record-keeping systems. By adopting technology, restaurants and retail locations can embrace and enforce stronger a food safety culture and help eliminate human error.

Electronic and intelligent checklists and digital record keeping on mobile, handheld solutions that are integrated into the Internet of Things (IoT) represent a major technological advancement over what was previously possible, and can manage and dynamically influence food safety processes. Through connectivity to the cloud, mobile, digital solutions can be deployed anywhere throughout a business, from warehouses to sales floors, to prompt the desired behaviors and provide a detailed, accurate audit trail of completion. Devices can also keep track of relevant safety alerts and recalls to improve efficiencies and initiate steps that may not be part of a typical routine.

Daily employee work schedules can be preloaded and custom electronic-based checklists and templates can be built specifically around potential hazards to manage employee tasks and processes. Any missed steps or violations are flagged for easy correction.

As tasks are completed, data is electronically gathered and transmitted directly to the cloud where it can be stored, analyzed and reported for compliance.

In addition, through the cloud and IoT, employees at various levels of an organization, from corporate headquarters to store managers, can view and access real-time data from each location. New information can be uploaded from any location and automatically distributed to a particular store, region or all locations across an enterprise. Enterprise-wide access helps ensure all locations are practicing the most up-to-date HACCP plan and procedures.

Digital food safety solutions have many benefits for a business:

  • Overall Food Safety: Ensures critical control points are monitored and proper corrective actions are taken when necessary
  • Higher Performance: Employees are reminded to complete assigned tasks, so more tasks are completed on time with fewer misses
  • Audit Trail: Detailed, automated audit trail of who completed the action, what time it was completed and the data retrieved from the action
  • Process Improvement: A single database of comprehensive information detailing timing, missed checklists, commonly missed items and top violations to help improve overall processes
  • Cost Savings: Fewer resources are needed to complete food safety inspections, a 60% reduction in time compared to pen or pencil and paper-based systems1
  • Quality Improvement: In addition to HACCP compliance, the information gathered can be used for quality control. For example identifying where there has been over- or under-cooking in the food preparation process

Handheld, wireless and cloud-based technologies can serve as more accurate, reliable and efficient systems. Electronic systems are part of the solution for businesses to comply with new FSMA regulations and improve food safety procedures. When implemented properly, these technologies can help turn food safety in a positive direction and potentially avoid the next foodborne illness outbreak.

Reference

  1. National Grocers Innovation Center, Center for Advancing Retail Technology. Intelligent Checklist for Quality and Safety in the Supermarket. Retrieved from http://info.partech.com/whitepaper-intelligent-checklist-for-food-safety
Manure, fertilizer, produce rule

Is Raw Manure Dangerous to Produce Safety?

By Food Safety Tech Staff
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Manure, fertilizer, produce rule

In light of the FSMA Produce Safety rule, FDA is asking industry for feedback on the use of raw manure (which has been seen as an effective method to enrich soil quality) and its potential to contain disease-causing bacteria. In a Federal Register notice just released, FDA is requesting “scientific data, information, and comments that would assist the agency in its plan to develop a risk assessment for produce grown in fields or other growing areas amended with untreated biological soil amendments of animal origin (including raw manure).” The risk assessment will evaluate and quantify any risk of human illness related to consuming produce grown in fields or other areas that contain such untreated soil for pathogens including E. coli O157:H7 and Salmonella.

The agency is asking industry for more information about how farms use raw manure, along with strategies that should be taken into account in order to reduce the health risk to the public.

The Federal Register notice will be published March 4. There is a 60-day period to submit comments and scientific data.

Deirdre Schlunegger, CEO of STOP Foodborne Illness
Food Safety Culture Club

A Face Behind Foodborne Illness

By Deirdre Schlunegger
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Deirdre Schlunegger, CEO of STOP Foodborne Illness

How is it possible that we are already near the end of the first quarter of the new year?  Time Marches on (pun intended). STOP Foodborne Illness continues to hear the devastating stories of foodborne illness. I am glad that companies vow to turn things around once things have gone wrong, but I do wish that the same companies had been paying attention long before individuals and families had to experience foodborne illness and live with life-long consequences. I believe that, when conducting in food safety training, sharing stories of those impacted by foodborne illness makes a difference. FSMA implementation is being taught, lectured about, absorbed, integrated, regurgitated and debated. FDA Deputy Commissioner of Foods and Veterinary Medicine Mike Taylor, along with his staff, intimately understand the “why” behind FSMA. Every step of the way, human life has been at the forefront of his prevention-based strategy and plans for new food safety legislation.

As company stock prices fall due to foodborne illness outbreaks, there are heartbreaking stories of families that may never recover emotionally—and this doesn’t always make the news. Chris, who was sick during the fall season, recently shared his story. 

Chris and his wife
Chris and his wife

He wrote, “I wish that I could express to another person what this experience has been like for me. The physical symptoms are so much more severe than a typical stomach flu or food poisoning, but the truly difficult part has been the emotional anguish I have felt. This illness has been traumatic for me, and I still struggle with the effects of it. I wish it would never happen to another person and I greatly fear having to go through it again when I am older or less healthy—I truly believed it would kill me. I also wish that others would be able to understand how scary it is to feel your life slipping away through illness like this. Feeling like your body is out of control. For it all to occur from eating what I thought was clean and healthy food is sad for me and I hope that no one ever has to feel or experience what I went through.”

Food safety is not a flavor of the month cause or a nice thing in which to aspire. It is critical for the good health of individuals and the good health of business.

Thanks for reading.

John Ryan, Ryan Systems, Inc.
FST Soapbox

Substituted Ingredients Are Only the Tip of the Iceberg

By John M. Ryan, Ph.D.
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John Ryan, Ryan Systems, Inc.

While the United States has no legal definition of food fraud, current thinking tends to be focused primarily on companies and products involved in the illegal substitution of one ingredient for another in a product. Such substitution generally involves substituting a cheap filler in the place of the labeled ingredient. In recent news, Parmesan and Romano cheeses have captured news headlines because of illegal “misbranding” of foods meaning that the label on shredded cheeses from companies like the Castle Cheese, Inc. company in Slippery Rock, PA include ingredients found through FDA testing that are included in percentages beyond allowable levels. In the case of shredded cheeses, so called “imitation” cheese better is known as wood pulp. The labels stated that the ingredients were 100% cheese.

Perhaps Slippery Rock is an apt name for the Castle Cheese operation where the inclusion of wood pulp was cheaper than the inclusion of real parmesan cheese. Such activities are becoming increasingly known as “economically motivated” and the practice is one of economically motivated adulteration. The FSMA final rule, Focused Mitigation Strategies to Protect Food Against Intentional Adulteration, will make these practices illegal.

Such intentional cheating has a long record in the history of food. No one really knows the extent of such food fraud activities, when they started (perhaps at the beginning of time?), or who could claim to be the first person to win an international award for creativity.

There are so many ways to commit food fraud that it boggles the mind and creates an almost complete inability on the part of governments, testing laboratories, food processors, retailers and the public to identify, let alone fully prevent and capture the guilty every single time.

Think about a few things. Is it fraudulent to leave the identification of GMO ingredients off of labels? If a packer knowingly packs a product in dirty packaging, is that practice fraudulent? If the food safety part of the government knows how high the levels of fecal coliform are on most of the produce we eat but does not acknowledge the problems or inform the public, is this practice fraudulent? How about the idea that a retail outlet replaces an “expired” label on hamburger with a new unexpired label? Or how about the time Sysco was shipping perishable foods in refrigerated trucks and storing eggs, milk, meat, chicken and other products in the same storage sheds where you might keep leftover junk from your garage? Do “Good Things Come From Sysco”?

But none of those examples have anything to do with intentionally substituting a cheaper ingredient for an ingredient on the label. Honey, olive oil, coffee, juices, fish, alcohol, milk and dairy products, fish, vitamins, meat, spices, organic foods, maple syrup, peanut product, flavorings, preserves, cereals, colorings, wines, vinegar, purees, sweeteners ,and other ingredients are involved. And food fraud occurs in manufacturing, processing, packing and food holding operations. Such large opportunities for all foods in all operations means the entire food chain is—at one time or another, in one place or another—suspect.

Ryan_foodfraud_packaging

The Grocery Manufacturers Association (GMA) estimates that food fraud may cost the global food industry between $10 billion and $15 billion annually with lost sales between 2% and 15%. They estimate that approximately 10% of all commercial food products are impacted.

Considering the fact that the food industry claims their profit margins are only a few percent, it would seem that if they wanted to reduce food costs, food fraud would surely be a prime business improvement target. And GMA, unfortunately, is also focused on economically motivated adulteration such as unapproved additives, mislabeling, counterfeit ingredients, transshipment (shipping from one country to another to repackage and relabel in order to avoid taxes), and dilution.

When a consumer enters a supermarket in search of fresh meat, poultry or fish to cook for dinner, he or she knows little about how those products were packaged. Adding water to the pad that is often inserted under the meat to soak up blood, adds weight to the scale and money to the price. Packing the meat using carbon monoxide is common in order to “preserve” the product color. Red meat should look red, right? While the FDA considers this practice generally recognized as safe (GRAS), studies regarding how carbon monoxide interacts with the foam packaging and the clear plastic wrap covering the package are nonexistent. What makes the practice deceptive is the lack of information on the label that tells consumers carbon monoxide is used to preserve color. Of equal importance are recent studies that clearly show that many of the plastics used in today’s food packaging operations contain toxic chemicals shown to be dangerous to humans.

Interestingly enough, the European Union has a definition of food fraud:

‘Food fraud is a collective term used to encompass the deliberate and intentional substitution, addition, tampering, or misrepresentation of food, food ingredients, or food packaging; or false or misleading statements made about a product for economic gain’.

After the monster European horsemeat scandal (remember that one?) in which horse meat was substituted for beef to the embarrassment of many companies, such as Burger King and Ikea, the United Kingdom promised proactive solutions from food laboratories and improving supply chain audits in an effort to slow and diminish the number of incidents reported annually.

In the United States, we frequently point to the melamine (milk substitution) in baby formula or the pet food problems that came out of China as evidence that foreign companies are primarily to blame for food fraud. Coupled with governmental trade agreements and the attitude that other countries are dumping substandard product on American consumers, it seems easy to blame others for food fraud –except for the fact that we in America are dealing with so many incidents.

The problem with our inability to tackle food fraud in part comes from the gap between our ability to identify and develop appropriate and targeted food ingredient testing capabilities. So many types of food, so many types of tests, so many types of ingredients, and so many types of ways to intentionally or accidentally cheat the system all combine to confuse and confound our efforts to quickly and economically establish detection systems.

In most food distribution arenas, food traceability systems are slowly being agreed upon and implemented. However, the FDA does not seem to be able to help with establishing data and other standards that would help establish traceability requirements designed to quickly and accurately get to the source suppliers in food fraud events. Other industries under FDA medical device and drug laws have worked to establish solid chain of custody systems. Chain of custody implies that the suppliers and handlers are legally responsible and clearly identified. Leadership in this area is clearly needed.

While there are many good resources evolving both within and outside of the United States, those resources are scarce and relatively immature. It seems that without some basics, such as legal definitions, standardized testing practices, and an agreement that food fraud is much more than substitution of one ingredient for another, we have a very long way to go if we expect to get the food fraud system under control.

Robert Califf, FDA

Senate Confirms Califf to Head FDA

By Food Safety Tech Staff
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Robert Califf, FDA

In an 89-4 vote by the U.S. Senate, Robert Califf, M.D., was confirmed as the next commissioner of FDA last week. The accomplished cardiologist and researcher will take on the task of implementing FSMA, along with responsibilities in overseeing medical device and pharmaceutical regulations, and tobacco products.

“I commend the Senate for their bipartisan vote today and am pleased that President Obama’s nominee, Dr. Robert Califf, will become the commissioner of the Food and Drug Administration, said Sylvia M. Burwell, HHS secretary, in a statement. “I look forward to working with Dr. Califf to ensure the FDA can carry out every aspect of its critical mission; from ensuring the safety and effectiveness of the medical products we use, to protecting the nation’s food supply and implementing its oversight of tobacco products, to furthering our efforts to combat opioid abuse.”

Specific Training Required Under FSMA: A Look at Each Rule

By James Cook
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All seven core rules of FSMA require general training of individuals or employees and qualified individuals requiring education, training or experience to perform specific tasks. By including training in these regulations, the FDA has made specific training mandatory.

Training Required by FSMA Final Rules

In the current Good Manufacturing Practices (cGMP) and preventive control rules, as per 21 CFR 117.4 and 507.4, all individuals engaged in the manufacturing, processing, packing and holding of food must have the education, training or experience to perform assigned duties and must be trained in the principles of food hygiene and food safety. However, the preventive controls qualified individual (PCQI) and qualified auditor, to rules 21 CFR 117.180 and 507.53, can be an individual who has successfully completed a class equivalent in curriculum to that recognized by the FDA, or have the necessary job experience. In both cases, the training must be documented, including the date of training, type of training and those personnel trained.

This means that all employees are to be trained in food hygiene and food safety to at least the standard presented in the regulations and more specifically as per the cGMP requirements. Additionally, individuals who are responsible for a specific critical control point will still need to be trained in HACCP. However, this will probably not be sufficient for an employee responsible for preventive control, as he or she may require training in Hazard Analysis Risk-Based Preventive Control (HARPC), or training specific to the area in which the employee is involved (e.g., allergens, sanitation, supply chain or recall programs, or preventive controls).

For the preventive control qualified individual and qualified auditor, the training needed may be that of the approved FDA curriculum, as developed by the Food Safety Preventive Control Alliance (FSPCA). Although this training course is not a regulatory requirement, FDA inspectors and other regulatory personnel who are auditing facilities will have completed this training, meaning qualified auditors will be expected to have this training, and eventually preventive controls qualified individuals (PCQIs) will be expected to do so too. The qualified auditor and a PCQI will still require the education, experience and other training to perform the specific job duties as listed in the regulations. Unfortunately, it is likely that neither the industry nor the government will have enough lead instructors ready to train everyone who would want or need to be trained before the compliance dates become effective. Additionally, this training course is not yet available for animal food, and the industry has been informed by FSPCA that a Foreign Supplier Verification Program (FSVP) training module will be added to the training course. The FSVP is discussed in the Supply-Chain Preventive Control module, and the fact that there are some similarities between these regulations helps individuals involved in the FSVP program, or in auditing it.

In the produce safety rule, training requirements are listed in subpart C 21 CFR 112.21, 112.22, 112.23 and 112.30. Personnel who require training are those handling covered produce and their supervisors. As with the cGMP and preventive control rules, the principles of food hygiene and food safety must be taught to these personnel. More specifically they must learn how to identify an ill or infected person, and be taught about microorganisms of public health significance, such as Salmonella, Listeria and E. coli O157 on food contact surfaces. Additionally, personnel who harvest covered produce must be trained in recognizing produce that is contaminated with known or reasonably foreseeable hazards to ensure it isn’t harvested. These personnel must be trained in the use of harvest containers and equipment to ensure that they are functioning properly, clean and maintained, and to identify when they are not. At the same time, employees must be trained in correcting any issues or in reporting them to a supervisor in order to have them corrected. All this training must be documented in the same way as the cGMP and preventive control programs.

Unlike the cGMP and preventive control rules, the produce safety rule’s requirement to have a qualified individual, supervisor or responsible party on each farm that has completed a recognized FDA course, or equivalent, is not optional. This course will be available through the Produce Safety Alliance and is anticipated to start in September 2016. The grower food safety course required for supervisors will include an introduction to produce safety, worker health and hygiene training, soil amendments, wildlife, domestic animals and land use, agricultural water, post-harvest handling and sanitation, as well as how to develop a food safety plan.

The training for produce, conducted by the Produce Safety Alliance and/or trained trainers, does not cover training for sprouts; training for sprouts is being developed by the Sprout Safety Alliance and will include topics specifically for sprouts, such as antimicrobial treatment of sprouting seeds.

In the FSVP, the qualified individuals must have the education, training or experience necessary to perform activities as per 21 CFR 1.503. These qualified individuals will develop the FSVP and those activities such as hazard analysis, supplier approval, determining verification activities and frequency, corrective actions and other activities for the FSVP. These personnel must be able to read and understand the records to be reviewed for this program. This means they must know English and may also need to know the local language at point of product manufacture or farming. 

At this time there is no structured training program for these individuals, but the FSPCA training program, alongside education and experience can provide the training necessary for these people to perform the job activities. A PCQI would be qualified for the role of a FSVP qualified individual, but the FSVP probably would not be qualified for the PCQI role. This is because the activities in the FSVP are not as complicated as those required by the cGMP and preventive controls rules, and therefore the FSVP qualifications would not need to be as stringent.

Training Under Proposed Rules

In the proposal for Sanitary Transportation of Human and Animal Foods, 21 CFR 1.910, the FDA requires carriers of these products to train personnel who are engaged in transportation operations. This should include awareness of potential food safety problems that may occur to food during transport, basic sanitary practices that would address those problems and the responsibilities of the carriers in the regulation. As with all training in these regulations, the type of training, who was trained and when they were trained must be documented.

Since this is a proposal, the training for teaching the carrier’s responsibility is not yet finalized but will require nothing more than explaining that section of the regulation. The training of potential food safety issues and the problems that might occur during transport are handled during standard cGMP and food safety training.

For the proposed Intentional Adulteration rule, per 21 CFR 121.160, the personnel and supervisors assigned to the actionable process steps must receive training in food defense awareness and their responsibilities in implementing the migration strategies. Also, as per 21 CFR 121.130, the vulnerability assessment is to be performed by a qualified individual, and this individual is to be qualified through experience and/or appropriate training.

For basic food defense, the FDA offers various courses and information, such as Food Defense 101, on their food defense webpage. An online course is offered in English and Spanish and covers the awareness training and the regulations for employees. Upon course completion, a certificate is provided. The agency also has a downloadable food defense plan builder that can be used to develop a food defense program. The agency also provides vulnerability assessment software, but additional training in PAS 96 or ISO/TS 22000 food defense would aid qualified personnel in making sure that this vulnerability assessment is correct and that the strategies to reduce risks are appropriate and not excessive.

There is an abundance of training courses and materials available from the FDA, USDA FSIS, associations and industry. FSMA employee training requires having personnel with the proscribed education and experience to perform specific tasks, and that they be trained as soon as possible in order for them to develop the programs. Additionally, all personnel should be trained at least annually in food hygiene, food safety and food defense.