Tag Archives: FSMA

FDA

Highlights of FDA’s 2021 Achievements in Food

By Food Safety Tech Staff
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FDA

At the end of his reflection on FDA’s 2021 accomplishments in the food realm, Deputy Commissioner for Food Policy and Response Frank Yiannas stated that he believes collaboration will enable industry to “bend the curve of foodborne illnesses in this decade”. It would be a significant milestone, and in his latest FDA Voices blog, Yiannas reviewed a host of FDA achievements that bring his statement much closer to a reality:

FDA Acting Commissioner Janet Woodcock gives of full report on the agency’s work in the “FDA 2021 Year in Review: Working For You”.

Compare this year’s review with that of 2020, where Yiannas reflected on the agency’s Food Program achievements during the first year of the pandemic and the 10-year anniversary of FSMA.

FDA

FDA Wants to Change Agricultural Water Requirements in Produce Safety Rule

By Food Safety Tech Staff
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FDA

After years of foodborne illness outbreaks that have been suspected to originate in pre-harvest agricultural water, FDA is proposing changes to the FSMA Produce Safety Rule. The proposed rule would revise subpart E, changing certain pre-harvest agricultural water requirements for covered produce other than sprouts.

“There have been far too many foodborne illness outbreaks possibly linked to pre-harvest agricultural water in recent years, including water coming from lands nearby produce farms. As a federal government agency charged with protecting public health, the FDA is committed to implementing effective modern, science-based measures designed to prevent these outbreaks from occurring in the future,” said Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response in an agency update. “The proposed rule is the latest action taken by the FDA to continue working towards implementation of key provisions of FSMA. If finalized, we’re confident this proposal would result in fewer outbreaks in the U.S. related to produce, protecting public health and saving lives. This proposed rule is a monumental step towards further improving the safety of the fruits and vegetables Americans serve their families every day, and the FDA looks forward to engaging with stakeholders on the proposed changes.”

Under the proposed rule, farms would be required to conduct yearly systems-based agricultural water assessments to assess and guide measures that would reduce risks related to pre-harvest agricultural water. According to the FDA, the assessment would consist of evaluating the water system, agricultural water use practices, crop characteristics, environmental conditions, potential impacts on source water by activities conducted on adjacent and nearby land.

With the current agricultural water compliance dates for covered produce other than sprouts set to begin in January 2022, the FDA plans to exercise enforcement discretion for those requirements while also proposing another rule that extends the compliance dates for all agricultural water requirements under the Produce Safety Rule.

The full details of the FSMA Proposed Rule on Agricultural Water are available on FDA’s website.

FDA

FDA Publishes Long-Awaited Final Rule on Lab Accreditation

By Food Safety Tech Staff
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FDA

At long last FDA has issued its final rule for Laboratory Accreditation for Analyses of Foods (LAAF). The FSMA rule establishes a lab accreditation program for testing food in certain situations and applies only to accredited bodies and food testing labs that opt to participate in the program; these ABs and labs must fulfill certain eligibility requirements.

“The establishment of the LAAF program will improve the FDA’s capacity to protect U.S. consumers from unsafe food by improving the accuracy and reliability of certain food testing through the uniformity of standards and enhanced oversight of participating laboratories,” CFSAN states in a news release.

According to CFSAN, the LAAF will apply to testing that is:

  • “to support removal of a food from an import alert through successful consecutive testing requirements;
  • to support admission of an imported food detained at the border because it is or appears to be in violation of the Federal Food, Drug, and Cosmetic Act;
  • required by existing FDA food safety regulations, when applied to address an identified or suspected food safety problem (i.e., certain tests of shell eggs, sprouts, and bottled drinking water);
  • required by a directed food laboratory order, a new procedure being implemented in this final rule that will allow the FDA to require use of a LAAF-accredited laboratory to address an identified or suspected food safety problem in certain, rare circumstances; and
  • conducted in connection with certain administrative processes such as testing submitted in connection with an appeal of an administrative detention order.”

The final rule will be published on the Federal Register on December 3.

Megan Coy-Moran, AIB

Be Confident in Your PCQI’s Training

By Megan Coy Moran
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Megan Coy-Moran, AIB

With allergens being the leading cause of recalls in the U.S., accounting for approximately 47 percent of recalls as of the most recent FDA reportable food registry annual report, FDA has placed “an emphasis on preventing allergen contamination, protecting consumers, and reducing the need for food recalls.” So, when FDA makes allergen control a priority, how can you be confident that it is a priority for your team and in your facility? By providing your designated Preventive Controls Qualified Individual (PCQI) with the right PCQI training.

Introduced in the Preventative Controls for Human Food Regulation final rule that exists within the FDA’s Food Safety Modernization Act (FSMA), a PCQI is required to be on staff in all food and beverage facilities registered under section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C) Act. In this role, the PCQI oversees development of the Food Safety Plan, hazard analysis, preventive controls, verification activities, and validation of process preventive controls. Further, FSMA mandates that all food manufacturing facilities conduct Hazard analysis and risk-based preventive controls (HARPC), while also implementing science-based preventive control measures to reduce the potential risk of food product adulteration. Each of these are managed by the PCQI and critical to achieving food safety.

With the goal of preventing foodborne illness and maintaining compliance with the FDA, the PCQI also needs to possess an in-depth knowledge of the facility’s Environmental Monitoring Program, food allergen controls, sanitation controls, supply chain controls, and recall plan. The importance of the PCQI’s many responsibilities means they need to have the necessary training and skills for the creation, application, and verification of these and other measures as applicable to their facility.

The PCQI’s oversight and familiarity with the Food Safety Plan also suggests they are likely the primary contact when FDA arrives at your facility for an inspection. Their ability to answer the inspector’s questions and successfully manage this process helps ensure that those visits are as concise and positive as possible. Having this single point of contact is also beneficial for the inspector, as they know they can count on the PCQI as a resource to provide them with necessary information without having to chase down multiple sources. Too, having a PCQI on site makes it easier to then implement regulatory requirements and any necessary preventive controls within the designated time, as they are already familiar with the facility and team.

The best PCQI training will prompt participants to think through real-world scenarios, preparing them to identify best practices to achieve food safety. By then putting this theory into practice in their facilities, they will help ensure compliance. Further, it is important that any course they take features consistently updated information, so you can be assured that what they are being trained on is current and accurate. For instance, when the U.S. Congress passed and President Biden signed the FASTER Act into law in April 2021, including sesame as an allergen of concern, this was an important update. As new information becomes available, their training should remain timely and accurate, ensuring that the experience is relevant and responsive to changing regulations.

Because production right now is priority and many teams are short-staffed, it can be difficult for some to find the time to travel to participate in an in-person training course. This makes online training appealing, as it can be completed when time becomes available, while also saving on travel costs.

With the right training, your PCQI will be an invaluable member of your team. By aligning priorities with regulators and prioritizing food safety throughout their responsibilities, they will improve your facility’s ability to produce safe food.

With our PCQI Online training, your PCQI will be an invaluable member of your team. By aligning priorities with regulators and prioritizing food safety throughout their responsibilities, they will improve your facility’s ability to produce safe food.

Kathryn Birmingham, ImEpik

Ask the Expert: ImEPIK Discusses Supply Chain Controls and PCQI Responsibilities Under FSMA

Kathryn Birmingham, ImEpik

Dr. Kathryn Birmingham, one of ImEPIK’s PCQI training experts, provides guidance to Juan, a future PCQI in a plant that receives ingredients for ready-to-eat energy bars.

Juan: I’m new on the food safety team at a small company and the next person to be trained as a PCQI. Our team wants to make sure we are meeting the requirements in our food safety plan under the Preventive Controls for Human Food Rule in FSMA. There are a lot of players along our ingredients supply chain. Who is ultimately responsible for product safety?

Kathryn Birmingham: As you know Juan, if you manufacture, process, hold or pack an ingredient or food product, food safety is your responsibility. For all of the players along the supply chain FSMA focuses on risk assessment and identifying hazards and preventive controls when required. Your team must have a plan and implement verification activities for the supply chain preventive controls for the food ingredients with hazards you have identified needing a control.

Juan: So, we are sourcing chocolate from a number of suppliers or our bars. They all provide COAs with the shipment that tell us the chocolate is manufactured to be free of pathogens like Salmonella. Usually we get a laboratory report on the sample testing for vegetative pathogens from the supplier for each shipment. We put that in our food safety plan to verify that the hazard was controlled by the supplier. But one of the suppliers has not provided sample testing results we requested. We have finished product to get out the door, but we have to ensure our product doesn’t harm consumers. On top of that, we can’t risk a costly product recall.

Kathryn: Right, Juan. That Certificate of Analysis may not be enough to verify that your chocolate supplier is effectively controlling for the hazard of Salmonella. For your product process flow the chocolate will never have a kill step to mitigate the hazard. If you cannot be sure that the hazard has been significantly minimized or prevented before receipt of the chocolate – per section 117.410 in the PCHF Rule – you have some choices to make. If you are using a foreign supplier there are considerations if the supplier is or is not in compliance with the FDA’s Foreign Supplier Verification Program.

Juan: So it looks like we may have to take on the cost and additional time of sample testing?

Kathryn: Remember, supplier approval is based on performance. If your supplier does not give you the evidence for verification you may need to conduct an onsite audit, perform sampling and testing and review other supplier records. You decide if the supplier meets your Supply Chain Control Program or Foreign Supply Chain Control Program.

Juan: My team members need to learn more about what we need to do to comply with FSMA and the PCHF Rule. Tell me about what we can learn through PCQI training.

Kathryn: Preventive Controls Qualified Individuals are trained in a methodical process for decision-making on hazards and preventive controls. The best training fosters a positive food safety culture and includes practice on team scenarios.

A PCQI must be able to identify hazards associated with a product and process, determine the appropriate preventive controls and develop associated monitoring and corrective actions for hazards that are identified. PCQIs must also establish and implement appropriate verification activities for the application of preventive controls. All of that is included in the food safety plan they oversee.

Juan: What choices do we have for online PCQI training?

Kathryn: First choose your food safety team members. If your company is registering with the FDA you are required to have at least one PCQI at each facility. Most companies train multiple or back up employees for the PCQI role to ensure they are covered during vacations, sick time, various shifts or employee turnover.

Look for courses that include the FDA’s standard curriculum, like ImEPIK’s PCQI Online. The PCHF Rule does not require that PCQIs hold a specific training certificate, but FDA inspectors want to see that the PCQI has been successful in a training with the requisite learning objectives and content. There are many PCQI training options on the market. Some providers claim that their training is the only accepted training – that’s simply not true.

Look for courses that have a multiple of scenarios with different food products and challenge situations for practice and wider breadth of learning.

ImEPIK’s PCQI Course is interactive and 100% online. The ten-module training is entirely self-paced thus does not require travel or scheduling on-line webinars or sessions. You simply log in, work through the course as you have time, and earn your completion certificate to document in your food safety plan. If you take a break, the work you have done will be saved, and you pick up where you left off when you return to the course. This allows for reflection and practice in the workplace as you move through the modules.

It’s an ever changing environment for the food safety professional and quality training makes a big difference in keeping up with changes and staying regulatory compliant. Take PCQI Online and position yourself and your facility for food safety success.

About Kathryn Birmingham, Ph.D

Kathryn Birmingham, ImEpikKathryn Birmingham, Ph.D., is Chief Operating Officer of ImEPIK. Birmingham leads the company’s course development teams and ensures that the online training solutions are of high quality. She is certified as a Lead Instructor to teach the FSPCA’s Preventive Controls Qualified Individual course.

Dr. Birmingham taught graduate and doctoral students at the University of Florida and served as Dean of Arts and Sciences at Florida State College. At the latter she lead the Biotechnology Degree program and Institute for Food Safety analytical lab. She was Principal Investigator (PI) for its National Science Foundation studies.

Content Sponsored by ImEPIK.

Chris Keith, FlexXray
FST Soapbox

How Foreign Material Inspection Can Impact Your Liability From Packaging

By Chris Keith
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Chris Keith, FlexXray

Packaging is an essential component of our modern, global food supply. While it helps us preserve and protect food and creates instant brand recognition for consumers, packaging also inserts an additional level of necessary risk mitigation into the manufacturing process. Liability stemming from packaging is a serious concern for food manufacturers of all sizes, with millions of dollars and brand-damaging lawsuits on the line. Processed foods need packaging to arrive in the hands of consumers, and processed foods are necessary to feed the world’s population. According to a survey conducted by the United States National Library of Medicine, “60% of calories consumed were from ultra-processed foods.”1 This shows the prevalence of processed foods and the significant impact packaging, a ubiquitous component of processed foods, plays in the food industry.1 However, if not handled properly, food packaging can be a significant liability.

Liability from packaging commonly presents in two ways: First, as foreign material contamination. Broken, damaged or defective packaging material can end up in food products, which increases the risk of a consumer attempting to consume contaminated goods. Second, packaging can be a hurdle to effective remediation of foreign material contamination, as goods can often not be efficiently or effectively inspected back through in-plant critical control points. The resulting disposal of product can contribute to food and environmental waste, as well as lost profits.

The harsh truth is that if manufacturers lack processes to identify, prevent or mitigate foreign material contamination when it occurs in packaged food, packaging can be a significant liability at every stage from the manufacturing facility to the store shelf. Following strict food safety plans can save countless hours, resources and dollars in the long run.2

Foreign Material Contamination: Where It Comes From

Foreign material contamination comes from multiple sources in the production cycle. It can come from raw materials, like animal bones ending up in boneless meat products. It can happen during the production process when a screw or seal detaches from a machine and gets mixed into a pie. It can be biological, like an insect ending up in a bag of chips. Or it can come from packaging: A shard of glass winding up in a jar of salsa or a plastic wrapper finding itself in a muffin. All of these foreign material contaminants are risks and dangers for which manufacturers can be held liable.

Packaging-related contamination is a high priority for manufacturers. Foreign material contamination due to packaging occurs when contaminants like metal, plastic, styrofoam and other objects end up where they do not belong, disrupting the integrity and quality of the product. Packaging materials can break down into tiny pieces that inline inspection machines may not be able to identify. Inline machines are calibrated for a certain size and certain types of foreign material contamination, which may not include packaging materials. Additionally, inline machines are often used at critical points during the manufacturing process but are not commonly used to inspect completed packaged products.

Break It Down: Liabilities Within Food Packaging

The party most affected by missed foreign material contamination is the consumer. Current consumer trends point to greater ingredient awareness, education and research into the companies from which consumers purchase products. The consumer mindset of environmentally friendly products and socially responsible purchases are impacting the food industry directly. Consumers seek transparency from brands about the products they’re ingesting. When a consumer discovers foreign material contamination inside a product, it creates frustration and eliminates trust. In addition to negatively impacted brand reputation, a foreign object from packaging can be incredibly costly. Recalls, especially those that require a local or national public warning, are detrimental to a brand’s reputation.3 Consumer trust in a brand is priceless and can take years to repair when broken.

In the age of social media, consumer reports of foreign material contamination can spread like wildfire across multiple platforms, reaching countless consumers across the world. One tweet about a contaminated product can go viral, costing corporations their reputations or worse–– lawsuits. An accidental miss somewhere along the production line can result in public outrage and cost the manufacturer millions of dollars in wasted product and crisis management. Suppose a consumer accidentally consumes a foreign contaminant from product packaging which results in injury. In that case, the manufacturer could be held liable for the medical bills and even long-term care if the injury is debilitating. These court cases can be highly costly monetarily and in terms of public perception.

In addition to legal liability from consumers, the loss of product for foreign material contamination is typically very costly when labor, storage, time, materials and lost revenue are taken into account. A producer who makes the moral and ethical decision to dispose of product that may be contaminated loses money doing so. They also risk harming their reputation with consumers by contributing to the problem of food waste.

In the 21st century, shoppers are increasingly looking “beyond the label,” and are concerned with the impact their purchase behaviors have on the environment.4 Consumers in younger demographics are significantly more likely to have a purchase decision influenced by a company’s impact on and concern for the environment. Packaging is a major concern for food manufacturers as they seek to lessen their environmental impact to meet market demands. This impacts foreign material contamination in two important ways. First, as packaging materials move towards the use of biodegradable materials, the capability of technology to detect the difference between packaging and food material must increase. Second, environmentally-friendly packaging is still relatively new compared to traditional materials, and the risks of foreign material contamination associated with these materials are still relatively unknown.

Manufacturers are in a difficult position when dealing with the liabilities stemming from packaging as a foreign material contaminant. Compounding this issue is the role packaging plays in preventing manufacturers from using in-house processes or inline equipment to inspect product back through Critical Control Points. Inline mechanisms for identifying foreign material contamination are not designed to inspect completed, packaged product. If producers dispose of and rework product, they risk harm to sustainability-focused brands, production quotas and bottom lines. If they attempt to identify the contamination themselves, they lose valuable production time and potentially lose perishable product to spoilage. With nearly every solution, another liability arises.

Packaging Contaminants: Prevention, Response and Liability

The FDA-required Hazard Analysis and Critical Control Points (HACCP) plan has seven principles to ensure manufacturers meet food safety goals from production to consumption. Physical, chemical and visual tests are involved to ensure foreign contaminants do not exist in products produced in the manufacturing facilities.5 The more detailed processes are in place, the more protected companies are from recalls and reducing the chance of a lawsuit where the manufacturer is liable. Implementing different programs and processes to prevent and diminish food waste ultimately positively impacts the manufacturer’s bottom line. The Business Case conducted a study called “Reducing Food Loss, and Waste” that found “99% of companies earned a positive investment when they implemented programs to reduce food waste”.6

Many companies engage third-party food inspection partners as an extra measure to ensure that their product is free from foreign material contamination. By electing to utilize third-party inspection services, manufacturers hit a trifecta: They can typically salvage the majority of on-hold product, reduce food waste, and with the right partner, get the data they need to have traceability of foreign material contamination issues at their plant.

Manufacturers should pursue third-party inspection partners that meet a high standard of excellence. The best third-party inspection partners use cutting-edge technology to inspect products in higher detail than inline machines. Their machines should be capable of identifying foreign material contaminants of all types and have a high capacity to turn around large volumes of product efficiently. Their machines should be capable of overcoming the obstacle of packaging as an impediment to inspection using machines with a larger aperture than typical inline tools. Lastly, third-party inspection adds significant value if it has the ability to find and retrieve foreign material contamination so manufacturers can effectively use the resulting data to identify and remediate problems within the plant. An inspection service that does not meet these criteria is not an inspection service, but merely a method for outsourcing the same practices that a manufacturer would conduct in-house.

Liability Questions Answered

So, when are companies liable for packaging issues? Unfortunately, the answer isn’t always black and white. FSMA is in place to help prevent foodborne illness, requiring Food Safety Plans. In addition, the FDA recognizes “that ensuring the safety of the food supply is a shared responsibility among many different points in the global supply chain for both human and animal food,” so manufacturers may not be the only ones liable in many cases.7 The problem arises when manufacturers miss foreign contaminants or if foreign biological contaminants affect the integrity of the packaging.

Even if companies take the necessary steps, incorporate a HACCP plan and are vigilant, contamination can, unfortunately, happen at any time to any manufacturer. Using a third-party partner as an outside resource for foreign material inspection is important. Choosing a third-party partner with the experience, certifications, technology, processes and reputation to protect your brand is critical. Manufacturers can validate their internal processes and data using reports from their third-party inspection partner more quickly than they could internally.

Food packaging and the potential liability involved can be daunting. Still, with proper processes and procedures in place, manufacturers can have confidence that their products are hitting the shelves with a low probability of recall or lawsuit due to a packaging issue. While there is always a chance of foreign material contamination, quality packaging materials, quality assurance processes and quality third-party inspection partners can significantly reduce a company’s potential liability.

References

  1. Baraldi, L. G. (March 9, 2018). “Consumption of ultra-processed foods and associated sociodemographic factors in the USA between 2007 and 2012: evidence from a nationally representative cross-sectional study.” BMJ Open.
  2. FDA. “FSMA Final Rule For Preventive Controls For Human Food”.
  3. Lusk, J. (October 15, 2019). “Consumer Beliefs About Healthy Foods And Diets.”
  4. Cheung, K. H. J. L. (2020). “Meet the 2020 Consumers Driving Change“. IBM.
  5. FDA(August 14, 1997). “HACCP Principles & Application Guidelines.”
  6. Hansen, C. “The Business Case For Reducing Food Loss and Waste.” Champions 12.3.
  7. FDA. “Food Safety Modernization Act (FSMA).
FDA

FDA Issues Letter to Industry Addressing Efforts to Reduce Chemical Hazards in Foods for Babies and Young Children

By Food Safety Tech Staff
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FDA

A report released last month by the Subcommittee on Economic and Consumer Policy revealed dangerous levels of toxic heavy metals in baby food. It stirred up quite a bit of controversy and concern, and raised questions over whether baby food manufacturers were hiding dangerous levels of toxic heavy metals in food, and whether FDA was doing enough to ensure the safety of food.

In an effort to assure the public that FDA is taking the issue seriously, the agency published a constituent update about its actions to further prevent or reduce toxic elements in foods for babies and young children. It also issued a letter to manufacturers and processors of baby and toddler foods as a reminder of the “responsibility under the rulemaking to consider chemical hazards that may be present in foods when conducting your hazard analysis,” which is part of the preventive control provisions of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food FSMA rule.

“FDA takes exposure to toxic elements in the food supply extremely seriously, especially when it comes to protecting the health and safety of the youngest and most vulnerable in the population. Toxic elements, such as arsenic and lead, are present in the environment and may enter the food supply through soil, water, or air,” stated CFSAN Director Susan Mayne in the letter. “Our goal is to reduce exposure to toxic elements in foods to the greatest extent feasible and to further advance progress in this area through more research and enhanced collaboration among stakeholders.”

The agency also stated that it is finalizing a plan to reduce levels of toxic elements in baby foods, including:

  • “Reviewing current action levels, as well as developing additional action levels, to help make food safer, including finalizing the arsenic in apple juice draft guidance and publishing a draft guidance with action levels for lead in juices.

  • Focused compliance and enforcement activities, including inspections.

  • Providing guidance to industry on how to meet their obligations under current regulations.”

The agency will also continue its surveillance sampling assignment that focuses on these products.

Kathy Wybourn, DNV-GL

Ask the Expert: Track and Trace–FDA FSMA Proposed Rule for Food Traceability

Kathy Wybourn, DNV-GL

Does the proposed rule apply to importers?

Kathleen Wybourn: Yes. The proposed rule will apply to all persons, who manufacture, process, pack, or hold foods on the FTL (foods on the Food Traceability List), which does include food importers, who engage in such activities. However, persons, who do not physically possess food, are not engaged in “holding” of food within the meaning of the proposed rule. This means that some persons, who import food, may not be subject to the rule, because they do not “hold” the food. As an example, a person, who coordinates the import of a listed food, but never takes physical possession of the food, would not be subject to the rule; while a person, who imports a listed food, and they physically possess it, would be subject to the rule, unless an exemption is applied.

Does the “one step forward and one step back” meet the requirements of the FDA FSMA Proposed Rule for Food Traceability?

Wybourn: No. The nearly 20-year-old requirement for tracing will not meet the new requirements of the new rule. The FDA’s proposed rule requires food and beverage companies to include the following records: a) companies should maintain a list that includes the description of all FTL foods shipped, along with a traceability product identifier; b) companies should also have a description of traceability reference records, and how different information is linked, such as purchase orders and bills of lading; c) companies must also develop traceability lot codes that identify the types of food at any point, when it is originated, created, or transformed.

Kathy Wybourn, DNV-GL
Kathy Wybourn, director of food & beverage, USA & Canada at DNV-GL

About Kathleen Wybourn, Director Food Safety, DNV GL North America

Kathleen began her career in food manufacturing at the NutraSweet Division of GD Searle/Monsanto where she held various managerial positions including managing analytical and microbiology labs, quality control, quality assurance, supplier audits and operations. Since leaving food manufacturing, Kathleen has worked in various food safety auditing management positions, including Director of Operations at the GMA as Director of the GMA SAFE program.

In 2008 Kathleen joined DNV as Director of Food Safety Solutions where she is responsible for the Food and Beverage division of DNV GL – Business Assurance. Kathleen has written articles on Food Safety Certification including: First Look: GFSI Adds New FSSC 22000 Standard, WAL-MART’s Magna Carta for Auditing, and Navigating the Jungle of Food Safety Standards – all published in various Food industry magazines. Kathleen was instrumental in the study conducted at Michigan State University on Food Safety Certification in the US titled “Food Safety in the U.S. Supply Chain – Consumer and Food Industry Perceptions.” Kathleen is very active with GFSI, having served on various Technical working groups and speaking at the GFSI Global Conferences.

Kathleen has a Bachelor of Science Degree from Northern Illinois University and an MBA from Loyola University of Chicago.

Content Sponsored by DNV.

Earl Arnold, AIB International
FST Soapbox

HACCP is the Past, Present and a Building Block for the Future

By Earl Arnold
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Earl Arnold, AIB International

“Food safety plan” is a term often used in the food industry to define an operation’s plan to prevent or reduce potential food safety issues that can lead to a serious adverse health consequence or death to humans and animals to an acceptable level. However, depending on the facility, their customers, and or regulatory requirements, the definition and specific requirements for food safety plans can be very different. To ensure food safety, it’s important that the industry finds consensus in a plan that is vetted and has worked for decades.

One of the first true food safety plans was HACCP. Developed in 1959 for NASA with the assistance of the food industry, its goal was to ensure food produced for astronauts was safe and would not create illness or injury while they were in space. This type of food safety plan requires twelve steps, the first five of which are considered the preliminary tasks.

  1. Assemble a HACCP team
  2. Describe the finished product
  3. Define intended use and consumer
  4. Create process and flow diagram
  5. Verify process and flow diagrams

This is followed by the seven principles of HACCP.

  1. Conduct the hazard analysis
  2. Identify critical control points
  3. Establish critical limits
  4. Establish monitoring requirements
  5. Establish corrective actions for deviations
  6. Procedures for verification of the HACCP plan
  7. Record keeping documenting the HACCP system

HACCP is accompanied by several prerequisites that support the food safety plan, which can include a chemical control program, glass and brittle plastics program, Good Manufacturing Practices (GMPs), allergen control program, and many others. With these requirements and support, HACCP is the most utilized form of a food safety plan in the world.

When conducting the hazard analysis (the first principle of HACCP), facilities are required to assess all products and processing steps to identify known or potential biological, chemical and physical hazards. Once identified, if it is determined that the hazard has a likelihood of occurring and the severity of the hazard would be great, then facilities are required to implement Critical Control Points (CCP) to eliminate or significantly reduce that identified hazard. Once a CCP is implemented, it must be monitored, corrective actions developed if a deviation in the CCP is identified and each of these are required to be verified. Records then also need to be maintained to demonstrate the plan is being followed and that food safety issues are minimized and controlled.

HACCP is, for the most part, the standard food safety plan used to meet the Global Food Safety Initiative (GFSI) standards. This is utilized in various third-party audit and customer requirements such as FSSC 22000, SQF, BRC, IFS and others. These audit standards that many facilities use and comply with also require the development of a food safety management system, which includes a food safety plan.

Further, HACCP is often used to demonstrate that potential food safety issues are identified and addressed. FDA has adopted and requires a regulated HACCP plan for both 100% juice and seafood processing facilities. USDA also requires the regulated development of HACCP for meat processing and other types of facilities to minimize potential food safety issues.

For facilities required to register with the FDA—unless that facility is exempt or required to comply with regulated HACCP—there is a new type of food safety plan that is required. This type of plan builds upon HACCP principles and its steps but goes beyond what HACCP requires. Under 21 CFR 117, specific additions assist in identifying and controlling additional food safety hazards that are on the rise. This includes undeclared allergen recalls, which constituted 47% of recalls in the last reportable food registry report published by FDA.

Prior to developing this plan, FDA provided recommendations for preliminary steps that can be completed and are essential in development of a robust food safety plan but are not a regulatory requirement. The steps are very similar to the preliminary tasks required by HACCP, including the following:

  1. Assemble a food safety team
  2. Describe the product and its distribution
  3. Describe the intended use and consumers of the food
  4. Develop a flow diagram and describe the process
  5. Verify the flow diagram on-site

Their recommended plan also requires a number of additional steps, including:

  1. A written hazard analysis. Conducted by or overseen by a Preventive Controls Qualified Individual (PCQI). However, this hazard analysis requires assessing for any known or reasonably foreseeable biological, chemical, physical, radiological, or economically motivated adulteration (food fraud that historically leads to a food safety issue only). You may note that two additional hazards—radiological and EMA—have been added to what HACCP calls for in the assessment.
  2. Written preventive controls if significant hazards are identified. However, similar preventive controls are different than a CCP. There are potentially four types of preventive controls that may be utilized for potential hazards, including Process Preventive Controls (the same as CCP), Allergen Preventive Controls, Sanitation Preventive Controls, Supply Chain Preventive Controls and Others if identified.
  3. A written supply chain program if a Supply Chain Preventive Control is identified. This includes having an approved supplier program and verification process for that program.
  4. A written recall plan if a facility identified a Preventive Control.
  5. Written monitoring procedures for any identified Preventive Control that includes the frequency of the monitoring what is required to do and documenting that monitoring event.
  6. Written corrective actions for identified Preventive Controls in case of deviations during monitoring. Corrective actions must be documented if they occur.
  7. Written verification procedures as required. This could include how monitoring and corrective actions are verified, procedures themselves are verified, and calibration of equipment as required. Also required is training, including a Preventive Control Qualified Individual. Additional training is required for those individuals responsible for performing monitoring, implementing corrective actions, and verification of Preventive Controls. Further, all personnel need to have basic food safety training and all training needs to be documented.

While the term “food safety plan” is used widely, it’s important that operations don’t just use the term, but enact a plan that is vetted, proven to work, and encompasses the principles of HACCP. Doing so will help ensure that their facility is producing foods that customers and consumers will know is safe.

FDA

In a Year of ‘Unprecedented Challenges’ FDA’s Food Program Achieved So Much

By Food Safety Tech Staff
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FDA

Earlier this week FSMA celebrated its 10-year anniversary, and FDA Deputy Commissioner for Food Policy and Response Frank Yiannas reflected on the progress and accomplishments as a result of this legislation, and the path forward. As we round out the first week of 2021, Yiannas is looking back at the achievements of 2020 in the face of the historic COVID-19 pandemic.

“I’m struck by how tirelessly our team members have worked together to help ensure the continuity of the food supply chain and to help keep food workers and consumers alike safe during the COVID-19 pandemic,” said Yiannas on the FDA Voices blog. “Their commitment has not wavered in a time when we’re all dealing personally with the impact of the pandemic on our families, schooling our children from home and taking care of elderly parents.”

  • Response to COVID-19. FDA addressed the concern of virus transmission, assuring consumers that COVID-19 cannot be transmitted via food or its packaging. The agency also worked with CDC and OSHA on resources to help promote worker safety and supply chain continuity.
  • Release of the New Era of Smarter Food Safety Blueprint
  • Release of the 2020 Leafy Greens STEC Action Plan with a focus on prevention, response and research gaps
  • Artificial Intelligence pilot program to strengthen the screening of imported foods
  • Proposed Food Traceability Rule issued in an effort to create more recordkeeping requirements for specific foods
  • New protocol for developing and registering antimicrobial treatments for pre-harvest agricultural water
  • Enhanced foodborne outbreak investigation processes and established the outbreak investigation table (via the CORE Network) to disseminate information about an outbreak right when the agency begins its investigation