Tag Archives: hazards

Dr. David Acheson is the Founder and CEO of The Acheson Group
Beltway Beat

Get Ready to Align Your Supplier Program with New FSMA Rules

By Dr. David Acheson
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Dr. David Acheson is the Founder and CEO of The Acheson Group

FSMA’s preventive controls rule mandates a supply-chain program to “provide assurance that a hazard requiring a supply-chain-applied control has been significantly minimized or prevented.” The rule defines a supply-chain-applied control as “a preventive control for a hazard in a raw material or other ingredient when the hazard in the raw material or other ingredient is controlled before its receipt.”

FDA made a few general updates in the final rule, including changing “supplier program” to “supply-chain program”, and it designated a subpart G with eight sections of regulatory text. Intended to improve clarity and readability, the language reflects its applicability to non-suppliers in a new requirement – that is, a supply-chain control can be applied and/or verified by a non-supplier (e.g., distributor, broker, aggregator). However, the receiving facility must verify the supply-chain-applied control itself or obtain documentation of the verification activity, review and assess the documentation, and document that review and assessment.

There are different compliance dates for the supply-chain program versus the entire rule, aligning  compliance with the dates of FSVP rule and providing greater consistency. This also addresses comment concerns that a receiving facility would be required to comply with the supply-chain program provisions before its supplier must comply with applicable new FSMA food safety regulations.

Does your current program comply with the new rules? If not, how can you bring it in line?

The Supply Chain Program

The rule requires a supply chain program when the receiving facility has identified, through its hazard analysis, that there is a hazard requiring a supply-chain-applied control. The program should address hazards requiring a preventive control that may be intentionally introduced for purposes of economic gain, as well as those unintentionally introduced.

FDA specifies the basic content of a supply-chain program, but allows for some flexibility. The rule mandates that the supply-chain program include:

  • Written procedures for receiving raw materials and other ingredients
  • Preventive control management components that include corrective actions and corrections, review of records and reanalysis
  • Supplier approval and use of only approved suppliers, but FDA is considering the issuance of guidance for temporary use of unapproved suppliers
  • Determining appropriate supplier verification activities
  • Conducting supplier verification activities
  • Documenting supplier verification activities:
    • Onsite audits
    • Sampling and testing of the raw material or ingredient (by the supplier or receiving facility)
    • Receiving facility review of the supplier’s relevant food safety records
    • Other appropriate supplier verification activities based on the risk associated with supplier performance and the raw material or other ingredient

In supplier approval and determination of supplier verification activities, the receiving facility must consider:

  • The hazard analysis, including the nature of the hazard, applicable to the raw material and ingredients
  • Where the preventive controls for hazards are applied
  • The supplier’s procedures, processes and practices related to the safety of the raw material and ingredients
  • Applicable FDA food safety regulations and the supplier’s compliance with them
  • The supplier’s food safety performance history relevant to the applicable raw materials, including results from testing for hazards, food-safety audit results and corrective action.
  • Any other relevant factors, such as storage and transportation practices

Other key points of the rule:

  • There must not be any financial conflicts of interests that influence the results of the verification activities. Payment must not be related to results
  • Domestic inspection by representatives of other federal agencies or by representatives of state, local, tribal, or territorial agencies may substitute for an audit
  • The definition of “supplier” has been revised so that the grower remains the supplier when the harvester is under separate management. The “supplier” is the establishment that “grows” food rather than that which “harvests” food.
  • Foreign suppliers may provide documentation, when applicable, of a written assurance that the supplier is producing the raw material or other ingredient in compliance with relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or has determined to be equivalent to that of the United States
  • The provisions for supplier verification in the FSVP rule have been aligned with the provisions for a supply-chain program, so importers and receiving facilities can consider compliance with both the supplier-chain-program rule and the forthcoming FSVP regulations, as to avoid  duplication of verification activities
  • If the receiving facility is an importer in compliance with the FSVP requirements and has documentation of verification activities under FSVP, a supply-chain program is not required even if the receiving facility’s hazard analysis determines that a supply-chain-applied control is required
FST Soapbox

HACCP, HARPC, and How Using Software Helps

By Steven Burton
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With nearly one in every six Americans falling prey to foodborne illnesses each year, food safety is a major public health issue. For several decades, current Good Manufacturing Practices (cGMPs) provided the basic food safety framework for manufacturers. However, these guidelines were not sufficient to cover all potential food safety hazards. In the 1960s, NASA asked Pillsbury to manufacture the first foods for space flights, and so the Hazard Analysis & Critical Control Point (HACCP) system was born. HACCP was later endorsed by the Codex Alimentarius Commission, which was formed by the Food and Agriculture Organization of the United Nations and the World Health Organization in 1963.

HACCP is a global standard and its principles are the defining elements of ISO 22000, BRC and SQF, all premiere global food safety standards. In 1996, an E. coli outbreak in Scotland claimed 10 lives. The Pennington report in the aftermath of this tragedy recommended use of HACCP by all food manufacturers to ensure food safety. While HACCP is mandatorily used for seafood, juice and USDA-regulated meat processing, it could not win universal acceptance across the food industry; most of the food industry sectors rely on cGMP for providing a food safety framework.

The number of people affected by foodborne illnesses can be attributed to a flawed food safety system. Thinking caps were put on and President Obama’s administration rigorously pursued what it hoped would be an effective food safety paradigm. On July 4, 2012 Hazard Analysis and Risk Based Prevention Control (HARPC) was introduced under FSMA section 103. Although the system is still a work in progress and FDA has yet not disclosed the regulations that will determine the functionality of HARPC, the agency is bound to issue the regulations by August 30, 2015. HARPC will become effective 60 days following this date, and companies will be required to enforce HARPC within a period of 12 to 36 months, depending on the size of a facility.

HARPC is designed along the lines of HACCP but is meant to be more comprehensive. For a “Simple Simon” it would be tough to differentiate between the two, but HARPC provides an all-encompassing food safety structure by focusing on preventive controls to make food safety more iron clad. With the exception of exempted facilities, HARPC will apply to all facilities subjected to FDA’s Bioterrorism Facility Establishment registration. All such facilities will be expected to enforce a functioning and adequate HARPC plan. Failure to do so and FDA would be authorized to take legal actions such as issuing a public warning letter or an import alert (in case of a foreign supplier), initiating criminal proceedings against a non-compliant facility, or suspending food facility registration of a facility until requirements are met. By doing so, FDA has put the onus squarely on the shoulders of respective facilities. Companies will be required to do a lot more and should expect deeper FDA involvement. Expert help to enforce a rather complex HARPC protocol seems unavoidable; there is a fair chance that users could find themselves lost in the translation and may end up facing FDA’s wrath if their plan is inadequate. Let me break it down a bit more and distinguish the main differences between HARPC and HACCP.

Qualified Food Safety Experience. HARPC requires one member of a company to be the qualified individual to complete an entire food safety plan. This means that said individual has undertaken education from a credible institution and gained experience by completing it. HACCP requires at least one person to be HACCP certified, but the plan must be constructed by a team of people.

Process Flow Diagram. Under the HACCP standard, food safety plans must include a clear flow diagram outlining the process, from start to finish, that the ingredients will take throughout your facility. HARPC has no regulations regarding this.

Hazard Variables. Traditionally, hazards were limited to biological, chemical and physical hazards under the HACCP paradigm. Yet, under HARPC, you must also outline Radiological and Terrorism hazards.

Controlling Hazards. Here is largely where the main difference lies: How to control a hazard. HACCP requires companies to mention their critical control points as well as outline a prerequisite program (PRP), although this has no set requirements. HARPC requires you to apply a sanitation preventive control to the hazards, which looks at monitoring, confirmation, corrective action, reviewing records and re-analyzing.

Reviewing the Plan. HACCP requires the individual in charge to review all HACCP documentation every year. This is in comparison to HARPC, which requires a facility to reanalyze its plan every three years.

Recall Plans. Recalls, as required under HARPC, are a special type of incident, with all of the attributes necessary to create and manage a recall plan. HACCP does not have such a requirement.

Use Software to Implement HARPC Plan

Using software can make life easier when it becomes time to implement a HARPC plan. Documentation is an important part of the HARPC system, and software can help generate most of the documents used to establish the plan. Such a system can link regulatory requirements with procedures and customize several aspects of the system during run time.

A risk analysis component of software helps a user identify the likelihood and severity of a particular hazard (a HARPC requirement). HARPC also requires sanitation control procedures at food surface contact points; software features can support cross contamination points to which hazards are assigned and controlled. Software also allows users to define equipment, with a facility to schedule and record calibration, maintenance, and verification activities, including management task assignment to satisfy HARPCs provisions regarding sanitation of utensils and equipment. In addition, it has the provision to document procedures as required by HARPC and can also flag employees for refresher training if they are involved in a violation.

Software also enables users to electronically record inspections, which satisfies the obligation under HARPC to carry out an environmental monitoring program (for pathogen controls). Interestingly, sensors could also be integrated with logging facilities to automatically collect sensor data, which could then be used to send out alerts if there is an abnormality. Software systems can also accommodate coverage of allergen hazards and run a food allergen control plan, including documentation of the process.

An incident management plan can assign and track corrective actions, root causes, employee retraining tasks, and preventive measures to individuals, and recall plans can be created and managed using the system. As many inspectors prefer remote review of documentation, software can provide such remote access, allowing inspectors to conduct off-site document reviews. This process can reduce on-site inspection times from five to three days. A list of approved suppliers can be maintained as well, and these suppliers can be linked to receiving functions, enabling users to receive and maintain a detailed and comprehensive record of ingredients.

HARPC is a reality that will have to be embraced very soon. Using software is a simple solution for the tough times that lay ahead for the food industry. It can serve as an all-encompassing and one-stop-shop for businesses that need help enforcing HARPC plans.

Food Defense Culture is Coming

By Maria Fontanazza
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FSMA’s proposed rule on intentional adulteration isn’t the only reason companies should be paying attention to food defense.

Establishing metrics in food defense, similar to the growing awareness around the importance of measuring behaviors in a food safety culture, was a topic recently brought up at FDA’s FSMA public meeting in the spring. The agency acknowledged that it will need to both clearly define what exactly is intentional adulteration and how it can be measured.

While food safety involves assessing and mitigating hazards, food defense is all about the threat and protection against intentional contamination. “The threat of fraud is a growing problem as supply chains get more complex, resources grow scarcer and the cost of food increases. All this provides more opportunity and potential reward for food adulterers,” stated a recent PwC report on food trust.

The FSMA final rule Focused Mitigation Strategies to Protect Food Against Intentional Adulteration is scheduled to be published in spring 2016, and companies need to be revisiting and revamping their food defense plans to prepare.

Prevention is the key word and on the most fundamental level of a food defense plan, businesses need to have management commitment before building, or even revisiting, a food defense plan—do they understand the resources, time and cost involved?

Conducting a vulnerability assessment is the first step in finding the gaps and examining whether a facility is secure. Beyond the standard questions that companies may ask when embarking on this assessment, businesses should identify potential attackers, asking how an attacker could have access to a product or process and what would be the outcome of an attack. Then look at the protective measures that are already in place—would these act as a deterrent? And if deterred, would the attacker proceed to the next target or would he or she stop? What measures are in place to find the attacker before there is an effect on the product?

When developing a food defense plan, there are several areas of potential vulnerability:

  • Shipping and receiving and packaging
  • Laboratories and testing sites
  • Recall and traceability programs and processes
  • Water used in processing/manufacturing—what is its origin?
  • Employees—what are the health risks? Is there a process for employee health reporting? Is there a process for reporting disgruntled employees?
  • Security personnel

With food fraud on the rise, it’s important for companies to continue to revisit and update their food defense plans, considering changes to facility designs or strategies, packaging changes, security improvements, etc. Companies should also be proactive in monitoring their employees both from a satisfaction (reducing the incidence of a disgruntled employee) and awareness perspective. FDA has initiatives to help companies build a food defense culture and employee awareness, including the ALERT training course for owners and operators of food facilities and Employees FIRST, and the National Center for Food Protection and Defense has programs aimed at workforce training as well as undergraduate and graduate curriculum on food defense.

Dan Okenu, Ph.D., Food Safety Manager, H-E-B
Retail Food Safety Forum

Food Spoilage and Food Loss in Retail Environments

By Dan Okenu, Ph.D.
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Dan Okenu, Ph.D., Food Safety Manager, H-E-B

It can be frustrating to consumers to discover some rotten fruits or not-so-fresh vegetables in their grocery packs in spite of due diligence at the stores. It also leaves a bad taste in the mouth while in your favorite restaurant, you’re served cold food, observe that the taste is just not right, the color of your favorite menu is not the same again or become suspicious that the food texture has been compromised and it doesn’t feel crispy or crunchy any more.

These are the tell-tale signs of food spoilage that customers are confronted with on a daily basis. In foodservice and retail environments, food spoilage constitutes a major food safety and food quality hazard with far reaching regulatory implications as well as being an economic burden with considerable food loss and profit loss. Food manufacturers and processors have achieved a high level of food preservation through several advanced technologies including heat treatment, temperature and water control, pasteurization and canning, specialized packaging like reduced oxygen packaging, fermentation and antimicrobial preservatives. However, food spoilage remains a major challenge in retail and food service. This is mostly as a result of the many food processing and preparation activities, food storage practices, repackaging and food portioning that are required in retail.

In addition, the modern consumers’ preference for fresh foods and the backlash on the use of unnatural preservatives leave foods more vulnerable to spoilage resulting in substantial food loss. Here, we discuss some of the challenges of food spoilage and how to minimize its impact on food safety, quality assurance and profitability in retail food operations.

Spoiled ApplesThe most important proactive measure against food spoilage is a tight managerial control on Supplier Food Safety and Quality Assurance. The condition of the food items upon delivery to the retail units will impact the overall shelf life, taste, texture, structural integrity and pathogen level during storage and food preparation activities. Food transportation best practices, cold chain requirements, temperature monitoring system, freeze-thaw detection, appropriate packaging, adulteration prevention and food tracking should be addressed at the supplier level to ensure that deliveries are wholesome safe quality foods. Integrated pest management at suppliers’ facilities and delivery trucks are also essential. Random testing of food products for pathogen content and quality control will assist in compliance with FDA/USDA regulations and internal corporate standards.Thus, a comprehensive evaluation and verification of the supplier food safety and quality assurance programs will help to ensure compliance with all relevant federal/State/local regulations (see previous blog on Supplier Qualification and Compliance using GFSI Benchmarking).

After suppliers deliver safe quality foods, in-store food safety and quality assurance control measures must be activated immediately to maintain safe quality food status until food is served to the customer.

At the retail units, appropriate food handling and storage practices to eliminate cross-contamination is key.

The use of rapid cleanliness monitoring test swabs to validate clean and sanitary food contact surfaces will enable timely corrective actions that would eliminate potentially hazardous food cross-contamination.

Proper hand hygiene by all foodservice employees should be mandatory.

Keeping cold food cold and warm food warm is a food safety mantra that ensures foods don’t get to the temperature danger zone. Temperature monitoring systems for freezers and refrigerators using wireless technologies will ensure a better food storage control even during non-business hours.

Emergency preparedness training for natural disasters and power outages should be in place to avoid surprises.

Compliance with FDA regulations for safe refrigerated storage, hot holding, cooling and reheating of food within the time and temperature criteria will help eliminate spoilage organisms and preserve the taste, texture and overall quality of food throughout its shelf life, especially for meat and poultry products.

Proper management of products’ shelf life, expiration dates and observing the principle of first in first out (FIFO) should be encouraged. In fact, the food code requires a system for identifying the date or day by which food must be consumed, sold or discarded. Product date marking enables compliance with this food code requirement to date mark all prepared food products, and to demonstrate a procedure that ensures proper discarding of food products on or before the date of expiration. Local health inspectors reference these product date marking labels and enforce them, in addition to food prep activities that may lead to cross-contamination, adulteration or spoilage. Inventory control, forecasting and Lean Six Sigma are important tools for managing food supplies, storage, preparation, stock replenishing and elimination of excess food items that may get past their shelf life.

Raw proteins (meat, sea food and poultry) are arguably the largest cross-contamination sources for pathogens in foodservice. Any novel pathogen reduction or elimination process like the potential production of pathogen-free chicken would be a welcome relief, and will not only save money and labor; it would protect the public health as well.

Produce (fruits and vegetables) remains the largest source of foodborne illness outbreaks in United States, because it’s a ready-to-eat food that doesn’t get the benefit of cooking at high sterilizing temperatures. An effective pathogen kill step for produce using consumer-friendly natural washes like electrolyzed water may serve as a gate keeper in case the safety system fails at the plant level. Ice-cold electrolyzed water is also known to refresh produce and may extend their shelf life as well.

GMO-food products could be engineered to resist pests and spoilage organisms with improved shelf life, but its general acceptability and the FDA labeling disclosure requirements are still contentious issues.

While industry is racing to develop several promising anti-spoilage technologies, active managerial control of the various components of an effective food safety and quality assurance system remains the best practice against food spoilage and associated food losses in retail food operations.

Dan Okenu, Ph.D., Food Safety Manager, H-E-B
Retail Food Safety Forum

Combating Norovirus Hazards in Retail Food Service – Part 2

By Dan Okenu, Ph.D.
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Dan Okenu, Ph.D., Food Safety Manager, H-E-B

Last week, in this blog we discussed that Norovirus is the leading cause of foodborne illness worldwide, some potential sources of outbreak, and the importance of proper handwashing and cleaning and disposal of body fluids. In this second part of the blog, we will cover developing an employee health policy, building a comprehensive food safety program, and training of employees.

Develop an employee health policy

It is important to develop an employee health policy with detailed guidelines for sick employees. Sick foodservice workers are required to stay off work until fully recovered and cleared by their Doctor. When an employee becomes sick at work, such an employee must report to the immediate supervisor, and be allowed to leave work to attend to the ill-health. Reportable diseases must be reported upon diagnosis to enable the Local Health Department and affected foodservice establishment take necessary actions to protect the public health. There should be a crisis management plan in case the media gets involved in any such reportable infectious disease situations. To enable ill-health reporting compliance by employees, foodservice establishments are encouraged to adopt an employee health policy that is not punitive in nature.

Managers and supervisors should also be trained to recognize abnormal behaviors and tell-tale signs of ill-health in employees who may choose not to report due to the potential of losing hourly wages. Employee health policy training should be mandatory – to report injuries, ill-health and to follow the exclusion policy from food prep until fully certified and cleared to return to work by the Doctor.

For more resources on employee health policy, please see FDA’s Employee Health and Personal Hygiene Handbook for practices and behaviors of food service workers that can help reduce the spread of infectious diseases in retail food operations.

Self-auditing of food safety procedures

Active managerial control will enable verification of the food safety program for potential corrective actions that may be required including retraining of staff. A self-auditing system will ensure that risk mitigation is applied at every stage of foodservice operations with HACCP plans implemented and verified. In addition, a third party auditing will identify the weak links in the system and help prepare the establishment for Local Health inspections. Proper cleaning and sanitation of contact surfaces, observing the temperature rule – keeping cold food cold and hot food hot or routine cleaning and sanitizing of high touch points surfaces are examples of food safety procedures that managers can evaluate and verify on daily basis to continue serving safe quality food to customers. Effective implementation of these food safety standard will have a direct correlation with reduction in cross-contamination including Norovirus prevention.

Comprehensive supplier food safety program

Food can get contaminated at any point during the farm to fork journey. A robust supplier food safety program will ensure better control of potential risk transfer in retail food operations. A system that ensures that approved certified suppliers are continuously verified will capture any potential system failure and implement corrective action both at the supplier and retail levels. The use of approved suppliers is an important risk mitigation step that should be mandatory and verified to ensure that all deliveries are of the highest food safety and quality standard. Since risk burden may be accentuated at retail foodservice due to multiple operational processes in the kitchen, it is important to assess the risk burden at the supplier level, to enable effective mitigation. Thus, a dedicated supplier food safety monitoring, evaluation and verification is absolutely required at retail foodservice to assist in eliminating any food safety weak link in the supply chain. The safe quality food outcome will remain complementary and supportive of the supply chain’s mission of “never run out”.

Training of employees on standard operating procedures

Proper and continuous training of employees is fundamental to a successful food safety program in retail food operations. We may have the best food safety program in place but if these important SOPs are not properly implemented at every operational step as a result of training gap, it may in fact introduce a greater risk into the system. Since most hourly foodservice workers are young adults with a higher than normal turn-over rate, effective communication and continuous training will help keep a good handle on the food safety know-how of each batch of employees. Consequently, it is absolutely necessary to have a certified food safety manager as the person-in-charge to oversee foodservice operations. Training the trainers, managers and training directors will assist in meeting the training needs of all employees including hourly and temporary workers and for compliance with food code requirements.

Online food safety courses and training is the preferred method of instruction for most large retail foodservice chains. These training materials can be accessed anywhere in handheld devices and can be updated in real time. Online training however should not be a replacement for personalized one-on-one onsite training on the job. Hand washing compliance, no bare hands contact with RTE foods, clean-up of body fluids, separating high risk raw chicken, beef and sea foods from RTE foods using a color coded system, and observing critical control points in the food prep process are some of the SOPs that require continuous training and verification to ensure compliance.

In conclusion, Norovirus is still a major infectious pathogen associated with foodservice operations in spite of several regulatory control and technological advances to curtail its occurrence and prevalence. Until a viable vaccine or an effective drug becomes available against Norovirus, rigorous implementation of food safety procedures, behavioral changes and continuous training of both foodservice workers and customers will remain the industry’s best practices at prevention and control. Overall, it makes a lot of business sense to do all that it takes to protect your customers against the threat of Norovirus infection, and by so doing, equally protect your business brand and the entire public health.