Tag Archives: FSMA

Tim Daniels, Autoscribe Informatics
In the Food Lab

Using LIMS to Get In Shape for FDA’s Visit

By Tim Daniels
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Tim Daniels, Autoscribe Informatics

FSMA is a major reform of the U.S. food safety laws. It shifts the emphasis for food safety to preventing contamination during manufacture instead of just responding to it. As part of the implementation process, the FDA will enforce these new rules during routine random inspections at food manufacturing sites. With such a significant change in emphasis, Shawn K. Stevens of Food Industry Counsel LLC, released an FDA Inspection Checklist. The checklist is designed to help food and beverage manufacturers to prepare for an agency inspection and to ensure they have the required controls and checks in place. Before we look in more detail at the checklist, it is worth reviewing some of the underlying requirements.

Some Basic Requirements

One of the fundamental requirements of FSMA is the establishment of an environmental monitoring program at each facility. It defines the testing protocols for appropriate microorganisms and verifies that the preventative measures undertaken are effective. Clear procedures and systems are required to identify the test microorganisms most suited to the risks in their systems. They need procedures to identify the locations from which samples will be collected and the number of sites to be sampled, since the number and location must be adequate to determine whether the preventative controls are effective. They also need to identify the timing and frequency for collecting and testing samples. The tests to be conducted must be specified, including the analytical methods used and the corrective action procedures in the event that testing detects an environmental pathogen or an indicating organism. Just as importantly, all of the data associated with this testing program needs to both be recorded and accessible for audit purposes.

Acquiring and Managing Environmental Monitoring Data

Any environmental monitoring program will come at a cost to the food manufacturer. While the program itself will need to be set up by experts in the field, much of the implementation can be carried out by lesser-qualified technicians. So a key aspect is having the tools to implement a program where the most effective use is made of each resource available, as this keeps costs down. In principle, one such tool is a Laboratory Information Management System (LIMS).  The use of a LIMS is commonplace in QA Labs to record and monitor laboratory samples, tests and results in order to simplify and automate processes and procedures. There is a variety of ways in which a LIMS could facilitate the environmental monitoring process to enable best practice even by non-specialist staff. For example, analysis can be simplified if each set of test results can be automatically linked to respective sampling points in the facility. Out-of-specification test results could be linked to corrective and preventive actions (CAPA). Test failures at a particular sampling point could be used to trigger more frequent testing at that point according to pre-set criteria.

  • The data management capabilities within a LIMS make it possible to:
  • Implement data management strategies that increase security and availability of data
  • Eliminate manual assembly of data for analysis and audit
  • Make data more useful with easy retrieval/visibility

Perhaps most importantly, a properly configured LIMS can provide a suitable framework for set-up and adjustment by the environmental monitoring expert, while reducing the expertise required to operate it on a daily basis.

Laboratory Information Management Systems
The Matrix Gemini Environmental monitoring solution is an example of an information management system that uses the capabilities of a LIMS to record and monitor laboratory samples, tests and results to simplify and automate environmental monitoring in QA Labs. Image courtesy of Autoscribe Informatics

FDA Inspection Checklist

This comprehensive document highlights the steps that companies need to take to prepare for the inspection process, navigate the inspection itself and respond to any criticisms arising from the inspection.

There are three main areas in the checklist where a LIMS could help satisfy FSMA requirements:

  1. Finalizing written food safety systems and making sure certain employees know the plans. LIMS provides the framework to set up documented food safety sampling requirements and track microbial test results over time. This facilitates recall and more detailed investigation should a sample fail.
  2. Well organized and maintained data, and ease of records access. LIMS should be capable of date and time stamping every entry and since it will contain all the test data over time, this can be easily recalled should the need arise. Typically a standard operating procedure would be developed, which will increase testing and start “out-of-specification” actions if abnormal microbial contamination is detected. LIMS can provide a full audit trail for all test data and produce reports showing result trends over time, highlighting variance and peaks in data.
  3. Proper documentation of corrective actions. In the event of failures, investigators will want to focus on the particular sample points and the “out-of-specification” actions that were initiated to investigate and resolve these failures. Typically three months of data is requested around these sample points, although up to two years’ worth of data could be requested. LIMS should allow data to be instantly pulled from the database as a report for further investigation.

FDA investigators will be most interested in what happens in the event of a failure and what learning gets incorporated into your regular regime. What happens when an out-of-specification result is obtained is the crux of preventive testing regimes. Actions might include changing sanitation methods, increasing test frequency or locations in areas of concern, segregating traffic patterns, re-training staff and so forth. Some of these actions, such as increasing test frequency, can be automated. All actions must be clearly documented, which can be done by adding appropriate records directly into the LIMS. This captures the actions that each quality improvement cycle needs in order to discover the likely root cause of any problems and how they may be avoided in the future.

All corrective actions should identify the root cause of the deviation, actions taken to prevent recurrence and, if product safety is not affected, a written conclusion (supported by factual and scientific data) that the deviation “does not create an immediate food safety issue.”

The emphasis should always be on preventive actions to remove potential points of failure before issues get into the final delivered products causing stock loss and costly recalls.

Configuring a LIMS for Environmental Monitoring

While most LIMS in principle provide the capability to handle the requirements of environmental monitoring, the system will need to be configured to do so, and this may not be a trivial exercise. The software will need to be configured to represent user requirements in terms of workflows, screen designs, menu designs, terminology, numbering schemes, report designs and much more. For many LIMS, full configuration for specific applications requires custom coding, which will require re-validation.

Once configured, LIMS can offer a practical way for food and beverage companies to document their sanitation/safety programs and instantly show written evidence of both testing and corrective actions when the FDA comes knocking.

Randy Fields, Repositrak
FST Soapbox

Foreign Supplier Verification Rule: Top 5 Questions Answered

By Randy Fields
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Randy Fields, Repositrak

The Foreign Supplier Verification Rule, part of FSMA, requires the importer of food to meet the same stringent guidelines found within FSMA’s Preventive Controls rule. Companies defined as the importer are now required to deploy a Foreign Supplier Verification Program (FSVP) that ensures their foreign supply partners are producing the imported food in compliance with processes that meet the FDA’s standards for preventive controls and safety.

Companies importing food products must anticipate hazards associated with the imported food and evaluate the risk posed by the food based on the hazard analysis and the supplier’s record of compliance every three years or when new information comes to light. In general, these companies must maintain the integrity of their extended supply chain.

Register for the Food Safety Supply Chain Conference | June 5–6, 2017 | Rockville, MD | in-person or virtualAnd now, the questions:

1.  Are you considered to be the importer under FSMA’s Foreign Supplier Verification rule?

Under FSMA, the importer is the U.S. owner or consignee of an article of food that is delivered to the United States from any other country at the time of U.S. entry. If you are still unsure as to whether you are the importer, try answering the three questions below. If you answer “me” to any of them, you might want to have your food safety team confirm your status as the importer with your foreign suppliers:

  • Who controls the finances of the imported food?
  • Who controls the agent?
  • Who controls the goods? Whose truck picks it up or in whose DC is the product stored?

2.  What comprises a FSVP?

The new regulation puts an additional burden on importers since it requires them to establish and follow written procedures for verifying foreign suppliers and correcting any violations of FDA standards. If you are considered the importer, you must have a separate FSVP in place for each food product and each foreign supplier, even if the same food is obtained from a number of suppliers. Proper documentation is essential to maintaining access to U.S. food markets since this will be the primary means by which FDA will establish compliance with FSVP. If you are not the importer, it might make sense to ensure you have copies of what your importer says he or she has on file.  (Hint: It’s a good idea to trust but verify in this situation.)

3. Can you meet the FSVP challenge?

Any record requested by the FDA must be available within 24 hours and could date two years back. If you don’t have an automated system, it’s time to consider one, as it’s really the only way to manage the range of documents required by a FSVP across a retailer’s or wholesaler’s vast supplier base. (Verification includes on-site audits, sampling/testing, records, certificates of conformance and continuing guarantees.)

4. What is the CEO’s responsibility under FSVP?

Senior executives in the extended retail food supply chain are personally responsible not only for their company’s compliance with FSVP, but also for verifying the compliance of their upstream supply chain.

5.  Why is Now the Time to Take Action?

Implementing a new system with suppliers will take time. It is your responsibility to ensure you and your suppliers are in compliance by the deadline. FSVP compliance goes into effect for most companies at the end of May 2017.

While we like to think of food safety as not being a competitive advantage, it can be used as leverage against the competition. So it’s critical to understand not only what the importer should be doing to comply with FSVP, but also what the supplier can do in advance to help the importer meet its obligations under the law.

Erika Miller
FST Soapbox

Employee Buy-in to Ensure FSMA Compliance

By Erika Miller
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Erika Miller

Getting employees on board can be one of the most difficult parts of any major change within a company. When things are operating just fine from the perspective of the employee, the cries of, “but we’ve always done it this way!” can be deafening. As a manager, it is our job to explain the new requirements in a way that encourages buy-in from employees at all levels of the organization, and to always present a united front with the company, even if we do not fully understand why a change is important. It is almost a guarantee a business would not spend money implementing a major change if there was not an impetus behind it. One crack in the façade can lead to an entire shift becoming demoralized and disheartened.

Compliance with FSMA is no exception. Although the aim of the act is to reduce food safety risks to the population of the United States, the added paperwork and regulatory requirements can seem onerous to the employees responsible for doing the work. I would encourage any managers who are experiencing some feelings of “why me?” to search YouTube for the videos made by families touched by major foodborne illness outbreaks. The pregnant mothers whose babies are infected with Listeria from deli meat sandwiches are particularly heartbreaking for those who have children.

Once a manager has convinced him or herself of the importance of compliance with the new food safety regulations, it’s time to get your employees on board as well. If you can, show them the same videos you saw to encourage their buy-in. Listeria is a danger in any plant handling a ready-to-eat product or one that could be improperly cooked by the end user. Remember, cooking instructions do not absolve the manufacturer of the responsibility to produce food free of hazards! With the internet, impactful videos are only a click away. Just remember to always fully vet the video before attempting an at-work viewing party—lots of people on the internet have senses of humor that may not translate well to the workplace.

Making the issue personal also works well. This is a great way to get the message home about allergens. In any group of associates, chances are good that at least one of them will have a close friend or family member who is affected by a food allergy. Ask people to raise their hands if they know anyone who is allergic to food. Ask them what that person must do to protect themselves. Frequently, the answer is that the allergic consumer can only read the label. This is a great teaching tool for the importance of proper labeling and can be used as a lead-in to the introduction of a new Allergen Preventive Control, if one is required. Ask the employees to visualize the people they know with food allergies when completing the required records, or performing the onerous tasks, and imagine themselves as the last line of defense.

Many companies employ the services of temporary agencies. These companies can offer a great solution for a company that is concerned about the exposure to litigation that can occur through employee separation. Some industries have high levels of turnover or seasonal operations, which can prove difficult to manage for busy HR departments. Turnover can lead to a loss of accountability as well, such as when an employee informs you that their training was deficient (leading to a major snafu). If their predecessor was not in the position long enough and the chain of training was broken, it can take a substantial investment of time and energy from a senior individual to train that relatively low-paid position back to base minimum level. Outsourcing some of the work to a temporary agency can seem like a godsend at first. They find them, they train them, and all the hiring company must do is eliminate downtime. Who wouldn’t?

However, over time, many companies find the time and money they saved at the outset comes back around to bite them in the end. Temp agencies often do not keep good records, and if you are relying on them to deliver crucial introductory food safety training before they send candidates to you to begin, you may end up in a bind when your auditor or FDA investigator asks to see your training records. The obvious solution is to bring all training back in-house, but that can partly defeat the purpose of having the temp agency in the first place.

Dr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology Laboratories
Food Genomics

Microbiomes a Versatile Tool for FSMA Validation and Verification

By Douglas Marshall, Ph.D., Gregory Siragusa
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Dr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology Laboratories

The use of genomics tools are valuable additions to companies seeking to meet and exceed validation and verification requirements for FSMA compliance (21 CFR 117.3). In this installment of Food Genomics, we present reasons why microbiome analyses are powerful tools for FSMA requirements currently and certainly in the future.

Recall in the first installment of Food Genomics we defined a microbiome as the community of microorganisms that inhabit a particular environment or sample. For example, a food plant’s microbiome includes all the microorganisms that colonize a plant’s surfaces and internal passages. This can be a targeted (amplicon sequencing-based) or a metagenome (whole shotgun metagenome-based) microbiome. Microbiome analysis can be carried out on processing plant environmental samples, raw ingredients, during shelf life or challenge studies, and in cases of overt spoilage.

As a refresher of FSMA requirements, here is a brief overview. Validation activities include obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified microbial hazards. In other words, can the food safety plan, when implemented, actually control the identified hazards? Verification activities include the application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended, and to establish the validity of the food safety plan. Verification ensures that the controls in the food safety plan are actually being properly implemented in a way to control the hazards.

Validation establishes the scientific basis for food safety plan process preventive controls. Some examples include using scientific principles and data such as routine indicator microbiology, using expert opinions, conducting in-plant observations or tests, and challenging the process at the limits of its operating controls by conducting challenge studies. FSMA-required validation frequency first includes before the food safety plan is implemented (ideally), within the first 90 calendar days of production, or within a reasonable timeframe with written justification by the preventive controls qualified individual. Additional validation efforts must occur when a change in control measure(s) could impact efficacy or when reanalysis indicates the need.

FSMA requirements stipulate that validation is not required for food allergen preventive controls, sanitation preventive controls, supply-chain program, or recall plan effectiveness. Other preventive controls also may not require validation with written justification. Despite the lack of regulatory expectation, prudent processors may wish to validate these controls in the course of developing their food safety plan. For example, validating sanitation-related controls for pathogen and allergen controls of complex equipment and for how long a processing line can run between cleaning are obvious needs.

There are many routine verification activities expected of FSMA-compliant companies. For process verification, validation of effectiveness, checking equipment calibration, records review, and targeted sampling and testing are examples. Food allergen control verification includes label review and visual inspection of equipment; however, prudent manufacturers using equipment for both allergen-containing and allergen-free foods should consider targeted sampling and testing for allergens. Sanitation verification includes visual inspection of equipment, with environmental monitoring as needed for RTE foods exposed to the environment after processing and before packaging. Supply-chain verification should include second- and third-party audits and targeted sampling and testing. Additional verification activities include system verification, food safety plan reanalysis, third-party audits and internal audits.

Verification procedures should be designed to demonstrate that the food safety plan is consistently being implemented as written. Such procedures are required as appropriate to the food, facility and nature of the preventive control, and can include calibration of process monitoring and verification instruments, and targeted product and environmental monitoring testing.

Elise Forward, Forward Food Solutions
FST Soapbox

Take Food Defense Concepts Beyond Your Four Walls

By Elise Forward
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Elise Forward, Forward Food Solutions

The new food defense regulations have caused quite a stir in the food industry and have left many scratching their heads. Many companies are worried about how to implement these programs. The regulations have created a format and structure in which many companies can adapt within their existing food defense programs to comply with the new law. Still, one of the biggest challenges of food defense is merely the idea of developing the food defense plan and coming into compliance with the FDA’s new Food Defense rule. The FDA received many comments from industry in response to the draft guidance. Many of these comments asked the agency for additional time to come into compliance, and the FDA responded by delaying the compliance dates well beyond what was proposed in the draft rules.

According to the regulations, companies are required to implement a food defense plan that focuses on the vulnerabilities in their facility. If you follow the FDA’s template, a food defense plan will look very similar to the traditional HACCP plan. The term, VACCP, Vulnerability Analysis Critical Control Points, is a term that is being tossed around as of late. The FDA wants companies to make sure that they consider an internal attacker, one that has inside access to the buildings, processes and products that are being produced. For many companies, this is stretching them beyond their current paradigms and may force some to implement new procedures. In reality, this paradigm shift is not insurmountable when the items to be controlled are within the four walls of their facility. Even subcontractors, such as pest control providers, maintenance subcontractors, auditors, etc., can be included in these programs. However, is this enough to ensure the safety of the product you are selling, the one you are putting your name on, and the one you are personally standing behind?

The goal of current risk-based thinking is to find the weakest link in the process, evaluate the risk and likelihood of a threat to food safety, and respond appropriately to control the risk. Unlike the Preventive Controls rule and the FSVP rule, the Food Defense rule focuses on the processes occurring in a facility and does not take into account the processes involved in the supply chain.  CargoNet Command Center found that there were 1500 security breaches in the transportation industry in the United States and Canada in 2015. The data was categorized by types of product and the highest percentage of any group of products was the food and beverage products which comprised 28% of the cargo thefts.  On average, that is greater than one food or beverage cargo theft per day. CargoNet Command Center provides a nice map on their website showing the location of these instances and I encourage you to review this map.  If your product passes along the hot spots of cargo theft, as well as having risk factors such as being valuable or in limited supply, it would be very beneficial to build systems and programs in place to address these additional risks to your product.

In another study presented at the Food Defense conference, there was a statistically significant link between breaches in IT systems to a follow-up cargo theft. Many quality and food safety professionals, much less executives, fully understand the interdependence of all business units on food safety. Many companies have problems with siloed departments, and unfortunately, this increases the vulnerabilities to attacks on the food we are trying to protect. This is a great example of how food safety is everyone’s job, and having this mentality is key to the success of food safety programs.

Of course, the requirement to the Food Defense rule must be addressed, but I challenge the industry to look beyond the walls of our facilities and instead, take a whole business approach and apply the principals of food defense to all inputs of the process that impacts the finished product. As food safety professionals, we need to work with our suppliers and our customers to ensure that the whole supply chain is protected from an attack.

Resources

Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC
FST Soapbox

GFSI in 2017: The Year of FSMA Compliance

By Bill Bremer
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Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC

This year is being described as “the year of FSMA compliance,” as many compliance dates for the various FSMA rules fall in 2017. As one might expect, the FSMA law and rules include many aspects of the established Global Food Safety Initiative (GFSI) standard; however, there are also differences in how they are applied to create better food safety enforcement.

At the most basic level, GFSI is an industry conformance standard for certification, while FSMA is a compliance regulation that must be met. However, both work together to ensure companies are effectively managing food safety.

GFSI Conformance

The GFSI is facilitated by the industry network of The Consumer Goods Forum. It provides a very solid foundation and supporting objective of “safe food for consumers everywhere”.

GFSI was originally established based on a growing pattern of food safety outbreaks throughout the international marketplace. This led to the proactive development of GFSI standards as an alternative to the more limited and less effective customer audits in place at the time. An important part of this outcome was that CEOs in the food industry—not a regulatory body—determined the need to address food safety through the GFSI food safety standard.

With its beginning as a benchmarking organization, GFSI has since evolved throughout the food supply chain as a strong means for achieving global food safety. It is now established, growing, and improving across the primary supply chains within the global food market.

As such, much work to address food safety has been accomplished by GFSI over the past sixteen years. In fact, the industry-driven aspect of GFSI along the food supply chain has led many companies to achieve levels of food safety comparable to those required to achieve FSMA compliance. Based on its collaboration of food safety experts, GFSI provides for a significant evolution of food safety programs and supports those requiring FSMA compliance.

FSMA Compliance

During a similar timeframe, the United States identified food safety as a major concern for the public. In the 1990s, a growing number of food outbreaks from biological contamination continued to spread, prompting the addition of controls within both the USDA and FDA. These brought the mandated requirement for Hazards and Critical Control Points (HACCP) and supporting Good Manufacturing Practices (GMPs) to specific industry sectors. However, these efforts were measured to have limited effect, as the outbreaks continued.

By the early 2000s, the public concern for food safety continued, and the FDA was determined to make changes. Along with Congress, the FDA commissioned research into the underlying issues that were resulting in the growing number and severity of food outbreaks. This research was being conducted and analyzed just as GFSI was determining its final group of benchmarked standards. At the same time, GFSI was positioned to be advanced into the U.S. market by food industry leaders, including Cargill, McDonalds, Walmart, Kroger, Coca Cola and Wegmans.

The outcomes from the FDA studies determined that the GMPs (in existence for the past 40 years) were not effectively implemented across the U.S. food industry. Further, the studies indicated that the ability to prevent food safety issues through specific controls would provide a means for reducing the number of foodborne illness.

This effort led to the development of FSMA, which passed in January 2011. Additional FSMA rules have since been published, starting in September 2016. The FSMA rules represent a rewrite of the existing FDA food safety regulations. However, with the FSMA law taking several years to roll out, the existing FDA laws remain in effect until they are replaced. These actions expand the FDA’s jurisdiction now and until full compliance of FSMA.

Bringing GFSI and FSMA Together

The presence of GFSI in the United States, as well as the GFSI certification of many suppliers to U.S. food importers, provides for a synergy between the GFSI standard and the FSMA law being enforced throughout the United States and its foreign suppliers. GFSI’s global focus provides the structure to adapt and meet many of the FSMA requirements, with the ability to expand to all FSMA requirements.

As one would expect, the FSMA law and rules include several aspects of the GFSI standard; however, there are many differences in how each is applied to encourage better food safety enforcement that must be considered. For instance, GFSI has the advantage of providing the time to develop programs, and thousands of companies are certified to the various programs under the standard. Conversely, FDA is implementing FSMA compliance over several years, with 2017 being a big year for compliance (based on the rules’ published dates, company size and industry segment).

In this new order of food safety in the United States, those companies that have achieved GFSI certification should have an advantage over those who do not, provided they can align their GFSI programs with the FSMA law requirements. There is also a benefit to starting with FSMA and moving to a GFSI certification.

Existing GFSI certifications provide an established framework, with many of the program requirements similar to those required by FSMA. For example, personnel are required by both to establish HACCP and Food Safety Plans, as well prerequisite procedures (PRPs) and current-Good Manufacturing Practices (cGMPs). The challenges are ensuring the complete development of these food safety procedures to guarantee they meet both GFSI and FSMA requirements.

As another example, personnel requirements are similar but different under FSMA and GFSI, which calls for training, updating and qualifying resources. Ultimately, advanced HACCP training under GFSI provides the means for establishing a Qualified Individual under FSMA, but it requires expanding the training to include FSMA Preventive Controls and procedures. The resulting plan is the food safety plan that can be based on HACCP but with the proper additions to meet FSMA requirements.

Global Food Safety Conference

The upcoming Global Food Safety Conference (February 27 – March 3 in Houston, Texas) provides an opportunity for those seeking compliance to FSMA or certification to a scheme within the GFSI Standard to get a deeper understanding of food safety. With 2017 being the year of FSMA compliance, it is very appropriate that the Global Food Safety Conference be held in the United States this year. The conference will provide U.S. companies attending, as well as foreign supplier of products to the U.S. market, an educational opportunity and forum to reach out to experts from industry, government, and academia to better understand these two key areas for food safety program development. Some of the topics to be addressed at the conference include the following:

  • Food safety management commitment and corporate governance
  • Required training of food safety roles, including management, staff and operations
  • Specific requirements of the documented food safety program or written programs under FSMA
  • FDA requirements of the past and existing requirements prior to FSMA and the relationship of these as comparable to GFSI
  • Implications for FDA enforcement under FSMA of these previous requirements and program requirements that may need to be formalized under FSMA
  • The proof of evidence with supporting records required by FSMA that may be addressed in part by existing or GFSI-level food safety programs
  • How to adapt a FSMA-level food safety plan and preventive controls cGMPs from existing programs, including GFSI, or develop these to function with existing programs
  • Levels and numbers of qualified individuals, qualified auditors and competent sanitation for oversight and management of FSMA food safety plans
  • Management reanalysis and update of the written FSMA programs to ensure compliance and readiness for inspection by FDA FSMA investigators
  • Process used to ensure compliance with FSMA Preventive Controls and the other FSMA rules being issued in 2017 and 2018, including Foreign Suppler Verification, Sanitary Transportation and Intentional Adulteration

Kestrel has been a long-time advocate of GFSI, performing site certification program development support for hundreds of companies. We have served as a GFSI Stakeholder, Technical Working Group participation, and panelist at previous GFSI Global Food Safety Conferences. We look forward to seeing you at the 2017 GFSI Global Food Safety Conference and to helping you navigate GFSI conformance and FSMA compliance requirements.

Food Fraud

Using Data to Prevent Food Fraud

By Maria Fontanazza
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Food Fraud

The FDA Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule is now final, and compliance dates for some businesses began in September 2016.  Economically Motivated Adulteration (EMA) or food fraud is a component in the Preventive Controls Rule.  As the global supply chain becomes more complex, preventing EMA and compliance to Preventive Controls for Human Food rule can be a challenging task.

A food company’s supply chain can be the weakest link in their food safety program. Learn strategies and how to mitigate risks at the Food Safety Supply Chain Conference | June 4–5, 2017 | Rockville, MD, LEARN MORELast year GMA and Battelle released EMAlert, a tool that enables quantitative evaluation of a company’s supply chain to economically motivated adulteration. USP also provides a platform to help companies with food fraud mitigation strategies. In a Q&A with Food Safety Tech, experts from the USP Food Program, Jeff Moore, Ph.D., science director and Karen Everstine, Ph.D., scientific liaison explain how the Food Fraud Database 2.0 works and how it can help companies with FSMA compliance.

Food Safety Tech:  How does the Food Fraud Database 2.0 assist food companies in identifying hazards and vulnerabilities?

Jeff Moore, Ph.D.: We reengineered the database [previously Food Fraud Database 1.0] from the ground up, including the structure of the data. Users wanted not just a source of high quality data to inform of risks and vulnerabilities that were related to food fraud but also some ability to analyze the information and get alerts and real-time information to figure out what to do in real time.

Karen Everstine, USP Food Program
Karen Everstine, Ph.D., USP Food Program

Karen Everstine, Ph.D.: Since it was reengineered, we’ve been able to include a lot of fields that allow food companies to tailor their results to information that is most applicable to them (i.e., geographic location). Automated analytics give a visual of what’s happening to see trends more quickly.

Moore: We have a team of dedicated analysts that are constantly scouting the public domain and looking for information globally to add to the database to make sure it’s the most comprehensive, up-to-date global database of food fraud information.

FST: What tools within FFD 2.0 can help companies with FSMA compliance?

Everstine: One of the things in the FSMA PC rule is the fact that food companies now have to identify potential hazards, whether they are intentional or unintentional, which includes food fraud-related hazards. One of the tools we built into the database is an EMA (Economically-Motivated Adulteration) hazard identification report. It allows users to input a list of their ingredients (those sourced and brought into the facility to create a finished food product), and then the report output identifies which ingredients are associated with potential hazards (i.e., adulterants that might pose a health threat to consumers). That’s the main tool we’ve built to target FSMA compliance.

Moore: One of the key parts of the PC rule as related to EMA is a question of whether the ingredient has a history of association with potentially hazardous adulterants. We put together an expert panel at USP and Karen [Everstine] was responsible for working with the panel to develop a classification system to identify adulterants that are potentially hazardous.

Sprouts

FDA’s Draft Guidance Aims to Help Keep Sprouts Contamination Free

By Food Safety Tech Staff
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Sprouts

Between 1996 and 2016, sprouts have been responsible to 46 outbreaks in the United States, which has led to nearly 2500 illnesses and three deaths, according to FDA. They have presented a consistent challenge to operators, because sprouts are most often produced in conditions that are ideal for bacteria growth.

Today FDA issued a draft guidance to assist sprout operators in complying with the FSMA Produce Rule, which requires “covered sprout operations take measures to prevent the introduction of dangerous microbes into seeds or beans used for sprouting, test spent sprout irrigation water (or, in some cases, in-process sprouts) for the presence of certain pathogens, test the growing, harvesting, packing and holding environment for the presence of the Listeria species or Listeria monocytogenes, and take corrective actions when needed.”

Large sprout operators must comply with the Produce Rule (applicable provisions) by January 26. Small business must comply by January 26, 2018 and very small businesses by January 28, 2019.

The draft guidance, Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations, is open for comment for the next 180 days.

FSMA, One Year Later: Top 5 Things We’ve Learned

By Erika Miller
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Now that the first of the FSMA compliance dates have passed, let’s look back at the past year of training new PCQIs, their questions and concerns from classes as well as the perspective from our FDA friends (yes, really!) who attended our workshops. We have learned so much, it is hard to narrow it down to only five things—but if we look at the issues that arose, the following five proved to be recurring themes throughout 2016.

5. Don’t Scrap Your Current Plan

Many clients have approached us and said they were planning to throw their current food safety and/or HACCP plan in the trash and start from scratch. Please don’t do this! Companies that care about quality and food safety already have effective quality management systems in place. It would be a disservice to the company and the general public for all these time-tested plans to go straight into the bin. It is more realistic to take a look at the current system in light of the new regulation and ask yourself if there are any gaps that can be addressed. This brings us to the next point.

4. Education Is Key

A compliant system cannot be developed without an understanding of the requirements. Although FSMA is derived from the basic principles of HACCP, there are key differences, and not all of them in the direction of less regulation. It is important to understand not only the updated Good Manufacturing Practices and Preventive Controls for both Human and Animal food, but also the Foreign Supplier Verification Program, Sanitary Transportation and the Produce Rule (if they apply). Although the FDA-recognized curriculum for some of these companion regulations have not yet been released, some independent training providers are offering workshops to help fill the gap while the FDA and FSPCA are working on the official curriculum. (Comment on this article for more information via email).

3. “You Must Evaluate If You Need It” Is Not the Same as “You Don’t Need It”

Some training providers have told their attendees that they can scrap many of their current systems because FSMA is less stringent than GFSI-approved schemes. Your certification body for FSSC 22000, SQF or BRC does not care one whit how stringent FSMA is (as long as you are compliant with its requirements, as local regulatory compliance is a key factor in GFSI approval). FSMA will not change expectations related to the GFSI-approved food safety schemes. It is also misleading to think that because FSMA is flexible, FDA regulators will not have expectations of excellence when they arrive at food processing facilities. This law gives regulators the power to take legal actions to address many infractions they have seen over the years but have been powerless to stop; the flexibility may well be a double-edged sword in that regard. Ensure that all decisions are based on data and records exist to validate any claims.

FDA

FDA Revises Draft Guidance for Listeria Control in RTE Foods

By Food Safety Tech Staff
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FDA

Any food facility that manufactures, processes, packs or holds ready-to-eat (RTE) foods should view FDA’s update on its draft guidance, Control of Listeria monocytogenes in Ready-To-Eat Foods. Consistent with FSMA, the draft focuses on prevention, and includes best practices and FSIS’s seek-and-destroy approach. Other recommendations include controls involving personnel, cleaning and maintenance of equipment, sanitation, treatments that kill Lm, and formulations that prevent Lm from growing during food storage (occurring between production and consumption).

“This guidance is not directed to processors of RTE foods that receive a listericidal control measure applied to the food in the final package, or applied to the food just prior to packaging in a system that adequately shields the product and food contact surfaces of the packaging from contamination from the food processing environment.” – FDA

The agency will begin accepting comments on January 17.