Tag Archives: FSMA

FSMA

Small Businesses: FDA Releases Preventive Controls Guidance

By Food Safety Tech Staff
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FSMA

In order to help small businesses with implementation of the FSMA Preventive Controls for Human Food and Animal Food rules, FDA has released compliance guidances. In an FDA release, the agency highlighted the following:

  • Small businesses (fewer than 500 full-time employees): Compliance with the human and animal food rules required by September 18, 2017
  • Very small businesses (those averaging less than $1 million per year in human food sales or $2.5 million per year in animal food sales): Required to maintain records supporting Qualified Facility status as of January 1, 2016
  • Qualified facilities must comply with the human and animal food rules by September 17, 2018

Both guidances are available on FDA’s website:

Guidance for Industry: What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Small Entity Compliance Guide

What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals

Question mark

Part III: FSMA IQ Test

By Food Safety Tech Staff
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Question mark

Here are the results of Part II’s FSMA IQ Test. If you haven’t taken Part II yet, follow this link. Under the results is Part III of the IQ test, results of which will be posted next week.

  1. Written supply chain plans are not included in FSMA food safety plans. FALSE
    • 92% answered correctly
  2. Mandatory recalls are provided under FSMA as a new requirement. TRUE
    • 82% got this right
  3. Under FSMA, FDA cannot unilaterally issue administrative detention and must work through a court order. FALSE
    • 93% answered correctly
  4. Under FSMA verification and validation, a thermometer challenge and calibration for use is an acceptable example of an established validation program and controls. TRUE
    • 85% said “true”
  5. Dogs may be allowed into some areas of the plant under FSMA. TRUE
    • ONLY 27% answered this correctly!
  6. Verification effectiveness of the implementation of preventive controls needs to be evident but not documented under FSMA. FALSE
    • 92% answered correctly

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FSMA

FDA Addresses Hazards Requiring Control in New Draft Guidance

By Food Safety Tech Staff
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FSMA

Today FDA released a new draft guidance related to FSMA: Draft Guidance for Industry, Describing a Hazard That Needs Control in Documents Accompanying the Food as Required by Four Rules Implementing the FDA Food Safety Modernization Act (FSMA) details the agency’s current thinking related to “disclosure statements made by an entity, in documents accompanying food, that certain hazards have not been controlled by that entity as required by certain provisions in four final rules”. These rules are the PC rules for human and animal food, the Produce rule and the Foreign Supplier Verification Program.

“This guidance provides our current thinking on how to describe the hazard under each of the four rules and which documents we consider to be “documents of the trade” for the purpose of the statements accompanying the food,” according to an FDA release.

The draft is available on the Federal Register and is open for comment 180 days after publication (October 31).

Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC
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FSMA Preventive Controls Corrective Action Requirements

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

FSMA Preventive Controls and Food Safety Plans must document specific use and management of corrective actions within Food Safety programs to satisfy the regulations and meet associated compliance dates. This requirement recently took effect under the Preventive Controls Rule on September 19, 2016 for companies with more than 500 corporate employees; food companies with fewer than 500 corporate employees have an additional year.

TEST YOUR FSMA SMARTS! Take the FSMA IQ TESTAs the FSMA Preventive Control rules move to enforcement status, food companies must prepare to best respond to the requirements and, correspondingly, to add the required written corrective action programs and records within Food Safety Plans. This may include providing an additional level of evidence that the company distributes safe food products to and from the United States.

With pending scheduled inspections on the horizon and the expanded authority of the FDA to conduct at-will inspections, it is critical for these programs to be written, verified and maintained at all times.  Important to note, even if this is a previously established program, you must be in compliance with the provisions of Section 117 of FSMA.

Learn more about FSMA Preventive Controls  at the 2016 Food Safety Consortium in Schaumburg, IL | December 7-8, 2016 | REGISTERThe more formalized programs and supporting evidence of compliance must include internal audits by Qualified Auditors, with coordinated oversight by your Qualified Individuals. Inspectors now have the authority to enforce the “letter of the law”. Additionally, organizations under the Preventive Control Rule must have multiple Qualified Auditors, in addition to Food Safety Plan Qualified Individuals, to oversee corrective action audits for evidence assurance.

Self-Diagnostic Assessment Tool

The following self-diagnostic assessment tool can help organizations better determine their current state of planning when it comes to implementing and managing corrective actions under FSMA Preventive Controls. To complete your own assessment, review and compare your programs to the questions below.

FSMA, Corrective Actions checklist
Table I. Kestrel Management’s self-diagnostic tool can help a company assess its level of corrective action programs for FSMA compliance.

Get Compliance-Ready

Companies must have the appropriate programs to comply with FSMA corrective actions or face possible willful non-conformance, which can include fines and criminal penalties under FDA enforcement. The questions in Table I will help companies identify areas to consider regarding their corrective action programs. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage all of your food safety requirements—and change “No” responses into “Yes” responses that promote best practices for FSMA and food safety compliance.

Part II: FSMA IQ Test

By Food Safety Tech Staff
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More than 400 people took Part I of the FSMA IQ Test. Read on for the results, and then take Part II of the FSMA IQ test (results of which will be posted next week).

Part I

  1. FSMA requires all records for the reevaluation of cGMPs every three years. FALSE
    • Only 31.8% got it right
  2. Implementation records are required for every FSMA requirement. TRUE
    • 77% answered correctly
  3. Plant borders not under the operator’s controls are not included within cGMPs. FALSE
    • 81% answered FALSE
  4. Under some circumstances, FSMA requires that conformance of a customer’s control of a hazard is required. TRUE
    • 85% got it right
  5. Under FSMA cGMPs, you must be able to identify at least 95% all possible contaminated product. FALSE
    • Results were almost split: 48% answered TRUE; 52% answered FALSE
  6. Monitoring of frequency of preventive controls must be conducted by the operation as part of the food safety plan. TRUE
    • 95% answered correctly.

Part II

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Joann Givens, FDA

What to Expect Now that the First Big FSMA Compliance Dates Are Here

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Joann Givens, FDA

The first major compliance dates have arrived for the preventive controls rules for human and animal food under the FDA Food Safety Modernization Act (FSMA). Some members of the food industry have expressed concern and uncertainty about enforcement measures that may accompany September 19, 2016. That’s the date when larger businesses must comply with certain new standards. Human food facilities must meet preventive controls and Current Good Manufacturing Practice requirements (CGMPs); animal food facilities must meet CGMPs. (The larger animal food businesses have an additional year to meet the preventive controls standards.)

Joann Givens, co-chair of the FSMA Operations Team Steering Committee and director of FDA’s Food and Feed Program in the Office of Regulatory Affairs, addresses questions that have been raised about what the next few months will look like for human food facilities required to comply with the CGMP and preventive controls requirements and animal food facilities required to comply with the CGMP requirements.

What happens next in terms of FDA enforcement of these new standards?
We know that this is new territory for food companies; it’s new territory for us too. For years we’ve been talking about the FSMA rulemakings and our implementation plans. Now, an important compliance date is here for some companies. As we enter this new chapter, the FDA’s primary focus will continue to be on education, training and technical assistance to help companies comply with the new requirements.

A top priority for FDA is providing the framework for industry’s implementation of preventive controls and CGMP requirements. We recently issued draft guidance documents that provide more detail on how to comply with the new standards, and there are more guidances to come, about two dozen planned over the next few years. We intend to continue this dialogue and collaboration with regulated industry to ensure that everyone understands and engages in their respective roles in food safety.

This first year of compliance will affect the larger businesses, generally those with 500 or more employees. Many businesses of that size already have a HACCP (Hazard Analysis and Critical Control Points) program; we don’t expect them to need to make many changes to come into compliance. Aspects of the CGMP and preventive controls rules are similar to HACCP, a food safety system that started with industry. (The human and animal food rules have staggered compliance dates; smaller businesses have a year or more additional time to comply.)

Does the focus on education mean that companies won’t really be held to these standards yet?
No. The FDA’s mandate is to protect public health and, when necessary, the agency will act swiftly. But keep in mind that our primary goal, not just in the first months but going forward, is to work with the food industry to create a culture of food safety, a culture of compliance with procedures, processes, and practices that we know will minimize the risk of serious illness or death.

What is the best thing covered food facilities can be doing now?
The best thing that people in the food industry can do is take the measures required by the new rules – not just the letter of the law but what it represents in terms of transforming the food safety system. They should look at the big picture, at areas in which they could be vulnerable and proactively take action. Promptly responding to problems, even if they aren’t yet violations, can prevent them from getting to the point at which there is a concern about the safety of the food.

In addition, facilities should set up a thorough system for documenting what they do. The better the records, the more a company can demonstrate that it is meeting the legal standard. Put processes and procedures in place to prevent problems in the first place, and consider having some redundancy in the system so that if one measure fails, another can take its place.

If there is a problem, state or federal investigators will ask questions like: When problems came to your attention, what did you do? Were you proactive in looking for the problems in the first place? If you could not find a solution, did you get the right expertise? Did you educate your employees?

Where can companies go wrong?
A company’s approach should not be: “The government was here and did our inspection. We’re safe for X amount of time.” Rather we want facilities to be confident that if FDA or the state walks in tomorrow, they’ll be able to demonstrate what they’re doing to meet the new food safety requirements.

And it really is up to the management of a company to create that culture by attending to the facility and its production processes and making sure that everyone in the production chain understands what is expected and has the training and education they need to get the job done.

What is the ultimate goal?
The purpose of these rules is to create a preventive, food safety system that is self-sustaining. Everybody in a food facility should be systematically operating in a way that complies with the law.

The preventive controls requirements fulfill the paradigm shift toward prevention that was envisioned in FSMA and, in combination with CGMPs, will help protect consumers into the future.

We want to see people doing the best they can. It’s a marathon, not a sprint. They’re learning; we’re learning. We are very committed to educating while we regulate to align understanding and expectations.

This article has been republished with permission from FDA. The original version can be viewed on FDA’s website.

Katy Jones, Foodlogiq
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The Clock is Ticking: Technology to Effectively Manage Recalls

By Katy Jones
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Katy Jones, Foodlogiq

It seems there isn’t a day that goes by without a food recall being announced. National brands like General Mills, Kellogg’s and Kraft alone have all experienced major recalls over products contaminated with such hazards as E. coli or undeclared allergens in the last few months. Food recalls are incredibly costly to a company, but can be handled effectively and efficiently with good planning, proper execution and the right technology to back it up.

Fortunately, the food industry is moving in the right direction to encourage better recall management by way of regulations under FSMA. Underscored by these federal mandates, the industry as a whole is moving away from a reactive approach to quality and safety issues within the supply chain, instead adopting a preventative plan of action.

The Multiplier Effect: How One Ingredient Can Lead To Multiple Recalls | Learn more at the 2016 Food Safety Consortium | December 7-8 | Schuamburg, ILRecalls are inevitable in the food industry, and in reality every company has, or will, experience one at some point. What sets a company apart essentially boils down to how they prepare for and react to a recall situation. If a company has done its due diligence to prepare for the inevitable (i.e. putting a recall team in place and implementing the right traceability technology), dealing with a quality or contamination issue can be less painful. Additionally, taking the right preventative steps can ensure a recall situation is proactively handled, rather than leading to a brand’s nightmarish public meltdown.

Getting Beyond “One-up and One-Back”

The industry has relied on a more linear approach to supply chain transparency—the “one-up and one-back” method (OUOB). Knowing where a product has come from one step back in the chain and where it is being sent or sold one step forward is no longer enough. To properly prepare for a recall, and manage product quality, it is imperative that a company employ whole chain traceability software, rather than relying solely on the movement of product within its own four walls.

The OUOB traceability approach is especially dangerous when handling high-risk, perishable foods, like produce or meat—which are often the culprit for recalls. According to a recent study in the Journal of Business Logistics titled, “Tracing Bad Products in Supply Chains” by Kaitlin Wowak, assistant professor of management at Notre Dame, “perishable products, like fresh produce and meats, flow through the supply chain very quickly. And while federal regulations mandate that firms have traceability one step up and down the chain, this may not be sufficient for these perishable products. In those situations, there is often a gap in the information received about the product, say a positive Listeria test, and where that product went in the supply chain.”

Root Cause Analysis is Key

When faced with a recall situation, time is of the essence. The time it takes for the recall team to identify the root cause of an issue and remove it from the supply chain could be the difference between sick consumers and serious brand implications. Being fully cognizant of the entire supply chain via a whole-chain traceability solution allows you to visualize a contaminant’s exact location; this information ultimately helps a brand streamline and manage the issue quickly and effectively.

Wowak’s research profiles a series of recall scenarios. One that was studied found that 50% of the food removed from the supply chain during that recall was actually affected—the other half was perfectly fine. Take the example of a batch of tainted tomatoes in your supply chain. Without being able to identify the root cause at the lot level, a company might be forced to remove all of the tomatoes from its supply chain.

Rather, by utilizing end-to-end traceability software, they can identify the specific farm, pack date and lot from which the produce originated. Tracing that information through each step in the supply chain—hether the tomatoes ended up on a pizza, in a can of salsa, or in a farmer’s market—allows the brand to manage the bad products without disrupting their entire chain or wasting perfectly good produce.

Unfortunately, without the visibility of whole-chain traceability, companies do not have the option to cherry pick tainted vs. untainted food from their chain. This is especially relevant as up to 40% of food in the United States goes to waste, according to the NRDC.1

Centralized Recordkeeping

When faced with a safety or quality issue, communicating information to relevant parties is necessary throughout the process. Especially with FSMA coming into play, if a company experiences a quality issue, they must promptly notify regulatory establishments and be sure to submit documentation and data in an immediate manner for investigative purposes. This can be hindered if a brand does not have a good handle on their supply chain data and must spend hours sorting through file cabinets, emails, or Excel sheets for proper documentation, or coordinating with suppliers for records. The longer it takes to comply with federal regulations and submit data around a recall, the more likely consumers, and the brand, are at risk.

The industry’s shift towards a preventative approach to safety is hitting a milestone as FSMA compliance periods have already taken effect. With this change, the FDA will no longer tolerate poor handling of contamination or quality issues. A company cannot get away with blaming a partner’s lack of transparency, or a supplier’s inconsistent records— the brand is now always accountable. In the coming months, we can anticipate added scrutiny from auditors, more mandatory recalls, even the shutting down of facilities due to noncompliance or negligence around safety concerns.

Having a robust supplier management system in place enables a company to be prepared for a recall situation. With all of your product and supplier data in one place, companies can quickly gather and allocate necessary data like audits and assessments to the appropriate officials, complying with the new required recordkeeping rules. By streamlining the availability of key information, and supporting seamless communication, a brand can be empowered to navigate a quality or safety issue.

As testing across the supply chain increases and the demand for fresh food rises, recalls are not going away. Fortunately, the move to a preventative approach to safety comes at a time where traceability technology is more comprehensive than ever. Food companies have the opportunity to invest in themselves with end-to-end traceability, arming the brand for the inevitable occurrence of a safety or quality issue. By enhancing visibility of the supply chain via an all-encompassing whole-chain platform, it is possible to track a product through each stopover to the consumer, from farm to fork. At the same time, housing all data in one efficient platform can ease the pressure of liaising with supply chain partners and regulatory bodies and streamline communications when faced with a safety situation.

While recalls are an inescapable part of the food industry, what sets a brand apart is how well they prepare and arm themselves with the technology to stay ahead. Implementing supplier management and whole-chain traceability software can help a company stay one step ahead of a recall, which makes all the difference when consumer wellness and brand reputation are on the line.

Reference

  1. Gunders, D. (August 2012). “Wasted: How America Is Losing up to 40 Percent of Its Food from Farm to Fork in Landfill”. NRDC Issue Paper. Retrieved from https://www.nrdc.org/sites/default/files/wasted-food-IP.pdf
Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC
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Post-FSMA Food Safety Inspection: Are You Ready?

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

Note: FSMA will include the scheduled compliance inspection as part of the implementation of rules. This will occur in the next several years for many food companies.

With FSMA rules moving to the compliance stage, food companies must prepare appropriately to best respond to the requirements and, correspondingly, to additional inspections. These inspections are in addition to others, including GFSI with its emphasis on unannounced level audits for some schemes. For example, these audits may be required by the code (as with SQF) or as part of customer arrangements per certification contracts.

Learn more about FSMA Inspection Readiness at this year’s Food Safety Consortium in Schaumburg, IL | December 7-8, 2016 | REGISTERWith the growing potential for inspections and audits, a well-planned program and response must be developed, implemented and tested to achieve a most successful outcome. This is an important area to address, especially given the many changes in compliance under FSMA, greater scrutiny under GFSI, and a rapidly changing responsibility for food safety management resources.

For companies experienced with past FDA compliance audits, the new rules and Section 117 cGMPs will require more formalized programs and strong evidence of compliance through internal audits and oversight by Qualified Individuals (QI). The inspectors will look to focus heavily on new requirements and the “letter of the law”. Additionally, organizations under the Preventive Control Rule must have multiple Food Safety Plan QIs, qualified audit resources and competent sanitation management, along with competent plant operators. It is critical to have established roles, planning and testing as part of any inspection readiness program.

Self-Diagnostic Assessment Tool

The following self-diagnostic assessment tool can help organizations better determine their current state of planning when it comes to developing inspection readiness. To complete your own planning assessment, review your progress compared to the questions in Table I.

FSMA Inspection checklist
Table I. Kestrel Management’s self-diagnostic tool can help a company assess its level of inspection readiness and preparedness for FSMA compliance.

Get Compliance-Ready

Companies must have the appropriate plans and resources to comply with FSMA and certifications or face possible violations that can include fines and penalties under FDA enforcement. The questions in Table I will help companies identify areas to consider for Inspection readiness. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage all of your food safety requirements—and change “No” responses into “Yes” responses that promote best practices for FSMA and food safety compliance.

Zia Siddiqi, Orkin
Bug Bytes

From HACCP to HARPC, and Integrating Pest Management

By Zia Siddiqi, Ph.D.
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Zia Siddiqi, Orkin

September 19, 2016 is a date that many of you probably had circled on your calendars. It marked the first date in which many food processing companies had to be in compliance with the FSMA preventive controls final rule.

It’s okay if you’re still revising your food safety plan. The regulations are so sweeping that some companies are still struggling to figure out if their plans are in compliance. At the heart of this law is a change in the philosophy of how we deal with contamination. Now, the focus is on preventing contamination rather than responding to it after it occurs.

This proactive approach to safety must be kept in mind when discussing how food safety plan requirements have changed. For many food manufacturing facilities, it means a change from HACCP to HARPC.

Hazard Analysis and Critical Control Points, or HACCP, should be more familiar to you. First developed in the late 1950s and early 1960s to provide safe food for astronauts in the U.S. space program, HACCP became the global standard for food safety in the 1980s, as large, multinational companies sought to ensure that their supply chains were safe.

HACCP evolved over the years into an effective, efficient and comprehensive food safety management approach. The system addresses food safety through the analysis and control of biological, chemical and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product.

The seven principles of HACCP include:

  1. Conduct a hazard analysis
  2. Identify critical control points
  3. Set critical limits
  4. Establish monitoring actions
  5. Determine corrective actions
  6. Develop verification procedures
  7. Institute a record-keeping system

How are HACCP and HARPC different?

Following the passage of FSMA, the FDA instituted a new set of food safety standards, known as Hazard Analysis and Risk Based Preventive Controls (HARPC).

HARPC shouldn’t be seen as a replacement of HACCP standards. Rather, it’s an evolution of them. The following are some key changes.

You Must Anticipate Potential Hazards. One of the big changes in moving to HARPC standards is that your food safety plan must identify any and all reasonably foreseeable food safety hazards and include risk-based preventive controls for them. This moves beyond HACCP’s critical control points and asks that food processors look at how to minimize risk from the second food enters their facility to the second it ships out.

This includes naturally occurring hazards as well as hazards that can be intentionally or unintentionally introduced to the facility. The potential hazards that have expanded under HARPC include:

  • Biological, chemical, physical and radiological hazards
  • Natural toxins, pesticides, drug residues, decomposition, parasites, allergens and unapproved food and color additives
  • Naturally occurring hazards or unintentionally introduced hazards
  • Intentionally introduced hazards (including acts of terrorism)

You should review the potential hazards—both seen and unseen—that could impact your facility to determine the risks that you should analyze for your plan.

HARPC Applies to Almost All Food Processing Facilities. The HACCP standards generally did not apply to all food processors. HARPC, however, covers many more U.S. processors. There are six major exceptions, however.

  • Food companies under the exclusive jurisdiction of the USDA
  • Companies subject to the FDA’s new Standards for Produce Safety authorities
  • Facilities that are subject to and comply with FDA’s seafood and juice HACCP regulations
  • Low-acid and acidified canned food processors
  • Companies defined as “small” or “very small” businesses
  • Companies with a previous three-year average product value of less than $500,000

Do these changes mean that your existing food safety plan needs to be scrapped? Not at all. An existing HACCP plan can be modified with the help of a Preventive Control Qualified Individual (another new requirement) to comply with HARPC guidelines. This person needs to be intimately familiar with potential hazards and the risk-based preventive controls for them.

This may sound daunting at first, but moving to HARPC from HACCP will be an easier shift than starting from scratch. The key adjustments that you would need to focus on include identifying risk-based preventive controls for the hazards previously mentioned. Just remember, these hazards should be expanded to include both naturally occurring and unintentionally introduced hazards.

How Does Integrated Pest Management Fit into a Food Safety Plan?

Much like HARPC, Integrated Pest Management (IPM) focuses on being proactive. It emphasizes prevention, focusing on facility maintenance and sanitation, before considering chemical options for pest management.

An IPM plan is benchmarked with regular monitoring and analysis of effectiveness. This may seem cumbersome, but one shouldn’t overlook the value of documentation as a management tool. Collecting data and putting it in context with detailed analysis can be an effective way to prioritize your pest control efforts.

Detailed analysis accounts for things such as normal seasonal cycles, deficiencies in maintenance, exclusion, sanitation and harborages, just to name a few. This analysis can also help improve pest control efforts by prioritizing areas needing attention, especially when your staff is limited by time or resources.

Integrating IPM into your HARPC plan should include analyzing the risks of what could encourage pests to enter your facility, such as doors left open or incoming product shipments. Consider your pest control provider an expert source in how to assess all risks associated with pests and how to establish preventive controls for them.

Despite preventative efforts, unexpected pests will be inevitable. More emphasis will be placed on establishing action thresholds for different pests. This can be a problematic topic, because there are not scientific or broadly accepted threshold values for food processing pests.

Every facility, and often zones within facilities, will likely be different. Identify logical zones—ingredients, processing, packaging and warehousing—and sensible threshold values for each key pest in these zones. Furthermore, establish what the appropriate response should be at certain thresholds. The escalating responses to different levels of pest activity often include things such as automatic authority for certain limited types of pesticide application, more intensive monitoring and inspection, and, of course, higher management notifications, which might lead to more extensive measures.

IPM plans should be reviewed on an annual basis to ensure your program remains as effective as possible. Written food safety plans that follow the HARPC approach and comply with the FSMA rule should be reanalyzed whenever there is a significant change at the facility that might increase a known hazard or introduce a new one. Review the plan at least every three years, if no significant changes occur.

Even if your facility’s deadline for compliance with HARPC standards is a year or two away, now is the time to take a look at your plan and make sure you’re in compliance.

Allergens

Allergen Management: Best Practices For Food Manufacturers

By Evan Rosen
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Allergens

Allergenic foods are a serious safety risk. While harmless to most of the consumer population, they are harmful and even life threatening to some, causing serious medical reactions, such as anaphylactic shock, when foods with the allergenic protein are consumed. Scientific research and legislation have helped us understand a great deal about managing these food allergens in manufacturing. Yet so much more needs to be done in making these risks safer for the growing allergic population. In 2013, the CDC reported that food allergies among children increased by half from 1997 to 2011. As these numbers continue to rise for children and adults alike, what are the best practices for food manufacturers to include in managing food allergens? Here’s what you need to know.

Evan Rosen is participating as a panelist in the session “Rubber Meets the Road: Practical Compliance with FSMA and Preventive Controls” at the 2016 Food Safety Consortium. The session will be moderated by Rajan Gupta and Dana Johnson Downing of TraceGains | LEARN MOREResearch and Development for Allergen Programs

Thorough development and foresight are essential for any food manufacturer to succeed when implementing an allergen program in its processing. It is wise for food manufacturers to select the individuals in their company who are a good fit to lead the allergen program. When developing your program, create an “allergen map” to understand where allergenic ingredients are located in your plant and how they travel while products are processed.

The R&D stage is the optimal time to plan every step of the allergen management process—from supplier sourcing to cross contact in processing, to labeling and every step in between—before the risks are actually encountered. This is in line with the new preventive controls approach to be taken with FSMA’s Food Safety Plan model.

Purchasing, Labeling and Storing Ingredients

When purchasing ingredients from suppliers, your supply sources should be just as stringent about allergen management as you are in order to reduce liability. Require your suppliers to have an allergen map of their own and lettered documentation declaring that the items you are purchasing are free from contact with food allergens. The FDA food label law currently recognizes the top eight food allergens as:

  • Peanuts,Tree nuts—including almonds, walnuts and hazelnuts, among others
  • Milk (not to be confused with lactose intolerance)
  • Eggs
  • Wheat
  • Soy
  • Fish
  • Crustacean shellfish (crab, lobster, crawfish, etc.)

Also, be mindful of allergens that apply to the country of export, such as Sesame Seeds, Sulfites and Mustard Seed in Canada.

When receiving and storing supplier ingredients, check the labeled contents for any updates and tag the units that contain allergens so they can be easily identified and stored separately. A pictorial system is very effective. Ensure that each unit is tightly sealed, as even slight amounts of leaked allergens can pose recalls and elevated risks to your consumers.

Processing and Cleaning Cross-Contamination

Human error is only one factor that predisposes risk of cross-contact; production timing, processing lines, facility traffic, protein structure (e.g. powder, liquid, paste) and even the type of equipment used can be a game changer when it comes to the proper handling of allergens. In order to prevent allergen cross contact, scheduling long lines of products with common allergens is recommended to minimize changeovers. Dedicate unique tools, utensils and equipment that will handle the allergen if possible, as every piece contacting an allergen must be washed before handling allergen-free processing.

Assign plant employees to specific locations to avoid risk of cross-contact travel—color coding uniforms helps a great deal in managing this concept. Manufacturing equipment that is designed for easy cleaning is also ideal. For cleaning procedure of cross-contact removal, wet cleaning methods are most effective followed by dry methods. These procedures should be validated using a recognized protein-specific test method such as lateral flow or ELISA. When flushing, be sure to keep the flushed material isolated from all allergen-free areas. Careful separation and mindfulness is key to a successful allergen program.

Staff Training and Education

In order for any allergen program to be effective, all plant, production staff, contractors and visitors must be aware of the importance of it and understand the impact it has on consumers. Incorporating different learning methods helps to communicate this to them. Occasional testing and validation of applying this knowledge ensures the integrity of your allergy-free claims and establishes trust. Passion and commitment also play a vital role in achieving success in your program as a whole.

From purchasing ingredients to staff education and cross-contact prevention, one can see that plenty of work and forethought goes into having an allergen management program. With these best practices in place, food manufacturers can be well prepared for the increasing demand of allergen safe products for consumers across national and international markets.