Food Traceability: Preventing Food Fraud
And Ineffective Product Recalls
With today’s complex food supply chain caused by changing industry processes and the consumer
demand for foreign foods, tracing products effectively is more critical than ever for food safety and
quality, and more challenging. However, the industry is struggling to find an effective traceability system
that would keep up with high production speeds. Flexible and modular traceability technology can solve
this problem and help food manufacturers improve their processes, supply chain efficiency, emergency
recall plan, without becoming a burden for production efficiency.
What is Food Traceability?
Food traceability refers to the systems that trace the flow of food through the food supply chain, including
through production, processing, and distribution, and make it possible to locate a product at any stage of
the food supply chain. Food traceability is important for a variety of reasons. The affected stakeholders
Public safety – As an anti-counterfeiting measure for products, Food traceability reduces food
fraud, which poses a risk to the public. It also allows for quick and efficient product recall,
reducing the impact that contaminated food products can have on public health.
Manufacturers – Tracing food products helps businesses manage emergency recall situations,
reduce their liability, and improve consumers’ confidence in their brand. An adequate system that
transmits accurate, consistent and complete product information can also decrease operating
costs and augment productivity.
Food supply chain – The supply chain benefits from food traceability because it makes the
process more efficient, improves cash flow, and reduces waste.
Consumers – Food traceability gives consumers confidence in the products they enjoy by letting
them know its origins and components. It also minimizes the risk of buying a fraudulent product,
labelled under your brand name.
The Benefits of Food Traceability During Recalls
When a food risk is identified, it is important that authorities and businesses are able to trace the risk to
its source so that they can prevent the affected products from being sold to consumers. Food traceability
minimizes disruption to trade by facilitating targeted product recalls and allowing brands to provide
consumers with accurate information. During a product recall, the contaminated products are quickly
located based on a serial number or batch number. With an effective traceability system in place, they
can also be traced back through the food supply chain to figure out where the problem originated.
When it comes to emergency food product recalls, food traceability helps in the following ways:
Preparation – Traceability provides businesses with a clear view of the supply chain, making it
easier to plan for an emergency recall situation.
Response – In the case of a recall, traceability improves the reaction of all parties because it’s
easier and quicker to locate the affected products.
Recovery – While recovering after a food recall, implementation of an effective food traceability
system increases consumer confidence and helps the brand rebuild its reputation.
Prevention – Traceability makes it easier to identify where the problem occurred and to prevent it
from happening again.
Would like to learn how to implement an effective food traceability system, customized to the
requirements of your specific application?
Food Fraud Risks and Losses
Food fraud is a global issue that affects all consumers. It endangers their health by contaminating food
products and sidestepping health and safety regulations. As food supply chains become more complex,
for example, by using more ingredients and crossing the supply chains of multiple countries, the potential
for food fraud increases. The World Health Organization estimates that 600 million people globally suffer
from a foodborne disease as a result of consuming a contaminated product. In addition to being a safety
issue, food fraud is estimated to cost the global food industry over $50 billion each year.
With food fraud rising at an alarming speed, governments and food manufacturers alike start recognizing
the benefits and developing own Track and Trace systems. The global seafood industry, for instance, is
now looking to create an adequate traceability scheme to prevent illegally sourced fish from entering
seafood markets. To achieve this, an interoperable electronic system will trace the movement of fish
through all supply chain touchpoints, from landing to retail.
Food Traceability Requirements
Since the traceability of food products is so critical, their traceability system must be accurate and complete. A food traceability system should be able to identify where a food product and its components were manufactured, packaged, and stocked, meaning that every stop on the supply chain has to get involved.
Today, food manufacturers are expected to be able to:
- Account for the origins and destinations of every product, including by weight of raw materials.
- Account for which material ended up in which finished product.
- Account for later production lots that contain products from earlier production lots.
- Make sure that the product packaging has unique lot numbers.
- Make sure that in the case of a food safety complaint, within four hours, the manufacturer can trace that product back to its ingredients and know where the rest of the ingredients went.
- Additionally, a food traceability system must record and be able to identify information such as: raw materials, additives, ingredients, volume, quantity, weight, dimensions and expiry date.
- Manufacturers must label products with unique identification codes that contain this information.
- Additional regulations apply to specific sectors of food products, such as beef, seafood, honey, and olive oil. These foods are often targeted for food fraud, so the requirements are intended to help consumers verify the authenticity and origins of products.
- There are also unique traceability rules for genetically modified organisms (GMOs) to ensure that the GM content of a product can be traced. Accurate labelling must be used so that consumers can make informed choices about whether or not to buy genetically modified products.
Is Food Traceability Legally Required?
Within the European Union, the General Food Law Regulation has established criteria for making sure that only safe food products make it onto the market. This includes the EU’s General Food Law of 2002, which made traceability mandatory for all food and animal feed businesses. Businesses must be able to identify their products‘ origins and destinations and make this information available to authorities. n the United States, two main FDA regulations deal with food traceability: the Bioterrorism Act of 2002 and the Food Safety Modernization Act of 2011 (FSMA).
The Bioterrorism Act requires that each facility along the food supply chain be able to identify where a product came from as well as where it is going next, in what is called a “one step forward, one step back” traceability requirement. The FSMA was introduced to expand upon the Bioterrorism Act by mandating the establishment and implementation of food safety systems in food supply chain facilities. This includes measures to prevent food product emergencies and a recall plan.
What is a Food Traceability System?
Traceability in the food industry is achieved through a Track and Trace system that includes a hardware
solution and an appropriate IT infrastructure to enable product data transfer. In essence, product
traceability rests on the following pillars:
- data management.
- tracing an
- data generation,
A traceability system is often implemented to enable anti-counterfeiting protection of products through securing product packaging. It provides a significant competitive advantage by minimizing the instances of mislabeling and therefore enhancing customer trust and loyalty. But just as importantly, an effective traceability system enables agile and efficient recall management, more control over a stock situation and enhanced production control.
Serialization in the Food Industry
Serialization of food products means assigning unique codes to food products. Serialization makes it easier for both retailers and consumers to identify and track original products, increasing consumer confidence.
Some countries, including South Korea, are starting to include serialization codes on food packaging. This enables manufacturers, retailers, and consumers to trace products easily from their origin, through the food supply chain, all the way to sale. It is predicted that serialization in the food industry will increase within the next few years to minimize the impact of food scandals and to increase consumer safety and brand transparency.
Aggregation in the Food Industry
Aggregation is an integral part of traceability in the food industry because it gives every step in the food supply chain the same information, making sure that there is only one source of truth. It allows food manufacturers to trace their products from production by maintaining parent-child relationships between the levels of food packaging. Here’s how it works:
- Beginning at the most basic level of packaging (retail packaging), a product is assigned a serialization code.
- As packages are combined in the next level of packaging (up to shipping boxes and pallets), the serial codes are aggregated into a new code label for hat packaging. This creates the so-called parent-child relationship, in which each individual package is assigned to a higher packaging unit.
- Each participant in the food supply chain, from the manufacturer to the distributor, receives the serialization information from the previous step and registers the receipt of goods in the system.
- Each data aggregate is recorded in a database before it moves on to the next step in the supply chain.
For additional educational and technical resources go to our solutions center: https://www.wipotec-ocs.com/en/food-traceability
Information on COVID 19
The current COVID-19 epidemic is caused by the coronavirus SARS-CoV-2, which belongs to the coronovirus family ( c oronoviridae) , a large family of RNA viruses. To date, the SARS-CoV-2 virus has been detected in respiratory, faecal and blood samples. The main route of transmission of the SARS-CoV-2 virus is directly through droplets produced when an infected person coughs or sneezes and indirectly through contact with infected surfaces (through hands which, without prior hygiene, touch the mucous membranes of the nose , mouth and eyes).
2. Presence of SARS-CoV-2 virus in the environment
Data on the time and conditions affecting the survival of the SARS-CoV-2 virus in the environment are currently limited. A study conducted at a Chinese hospital during the COVID-19 pandemic on the contamination of areas treated for COVID-19 infection showed that positive samples for the virus were found in Intensive Care Units (ICUs), delivery rooms and nursing clinics. The SARS-CoV-2 virus was also detected on computer keyboards and door knobs. The virus was detected with a frequency of 15.4% in gloves and 1.7% in masks or glasses.
Other recent studies, which have examined the survival of SARS-CoV-2 on surfaces, show that the virus survives up to: 4 hours on copper, 24 hours on cardboard and 2-3 days on plastic or stainless steel surfaces, but with significantly reduced viral load. Also, a study performed in rooms of patients with COVID-19 infection showed different levels of environmental contamination, ranging from 1 positive environmental sample for SARS-CoV-2 virus in 13 samples and 13 positive environmental samples in 15. Finally, controlled laboratory production experiments aerosol showed that the environmental stability of SARS-CoV-2 virus reaches 3 hours in the air after aerosol production.
The above data confirm the presence of the SARS-CoV-2 virus in the surrounding area of patients with COVID-19 and reinforce the view that surfaces and objects play a role in the spread of the virus. Adequate cleaning and disinfection of the environment is therefore considered necessary to limit the spread of the SARS-CoV-2 virus.
3.Environmental measures to control the spread of COVID-19 infection
Environmental measures to control the spread of the virus include:
- adequate ventilation of the premises
- systematic cleaning and disinfection of used surfaces, objects, equipment and clothing (bedding, towels, clothing)
- waste management
4.Instructions for ventilation, cleaning and disinfection of healthcare facilities exposed to SARS-CoV-2 virus
4.1. General recommendations for ventilation
- Cooperation with the technical service is necessary to establish guidelines for the protection of workers and patients, depending on the way of ventilation / air conditioning of each room and the presence or absence of HEPA (high efficiency particulate air) filters.
- The time that the air in a room without negative pressure remains potentially contagious is not known and may depend on various factors, such as the size of the room, the number of air changes per hour, the length of time the patient has been in the room. , if the patient had a severe cough or sneeze and if an aerosol-producing operation was performed 1 . Therefore all these factors must be taken into account for the ventilation time of the room.
- Potential air pollution is reduced from 100% to less than 1% within 30 minutes for a room with active ventilation 10 to 12 air changes per hour (ACH) and within 1 hour for a room with active ventilation 6 air changes per hour (ACH ).
- Recycling of air without ensuring its continuous cleaning with HEPA filters should be completely avoided, especially in aerosol production areas. More information on measures to ensure Public Health from viral and other infections when using air conditioners are available in a relevant circular of the Ministry of Health at the following link: https://www.moh.gov.gr/articles/health/dieythynsh- dhmosias-ygieinhs / metra-prolhpshs-enanti-koronoioy-sars-cov-2/7108-lhpsh-metrwn-diasfalishs-ths-dhmosias-ygeias-apo-iogeneis-kai-alles-loimwksei-s-kata-th klimatistikwn-monadwn .
- The use of portable units with HEPA filters to filter the air near the patient’s point is an appropriate solution, where required.
- The spaces with natural ventilation, which examined patients with suspected or confirmed COVID-19 infection, must be adequately ventilated and the doors constantly closed unless it is autonomous space (building or isobox) outside the hospital building, where the door can be left open, if the general conditions allow (eg distance from adjacent buildings, presence of passers-by).
- The space L with natural / passive ventilation which have not been handled generating aerosol in cases of suspected or confirmed infection COVID-19 is recommended to be ventilated with fresh air for 1 hour to accept new patient who is not suffering from infection COVID -19 (eg CT scan if there is no active ventilation system with specific air changes per hour) . Cleaning can be done in 1 hour if the cleaning staff wears the required personal protective equipment.
- The space L with natural / passive ventilation which have been handled producing aerosol in cases of suspected or confirmed COVID-19 infection recommended ventilated with fresh air for 1-3 hours to accept new patient who is not suffering from COVID -19 infection . These sites do not include sites where a SARS-CoV-2 pharyngeal smear is obtained, because a nasopharyngeal or pharyngeal sampling for the SARS-CoV-2 virus is not considered as an aerosol production operation in itself. This practice is sometimes included in the list of aerosol-producing treatments, as it may cause the patient to cough and / or sneeze at the time of sampling and therefore increase the risk of exposure to the personnel collecting the sample as it is close to patient.
- The ventilation times mentioned in the two paragraphs above do not concern the personnel of the sanitary unit, who can normally enter the mentioned areas, wearing the necessary personal protective equipment, as the case may be.
4.2. General recommendations for cleanliness and disinfection
- Systematic and proper cleaning with the usual procedure (use of detergent, water and mechanical abrasion) and disinfection of surfaces and objects in health care areas, is crucial. It is noted that spraying the area or nebulizing as a method of disinfection is not recommended .
- The basic principles of cleanliness and disinfection apply to the cleanliness and disinfection of premises and equipment, which each health service area should have established by applying the necessary procedures regarding:
- the manner of cleaning and disinfection, including the use of appropriate personal protective equipment, as appropriate;
- the types / categories and quantities of cleaners and disinfectants used depending on the space, surface or equipment and the required level of disinfection (high, medium, low),
- the management of cleaning equipment and
- staff training.
- All surfaces potentially contaminated with SARS-CoV-2 virus (including objects) must first be cleaned with neutral detergent and water and thorough mechanical abrasion and then – after drying – disinfected, depending on compatibility of the material in the disinfectant, with:
- Disinfectant preparation, with proven action against invertebrates , approved by the competent bodies, always following the manufacturer’s instructions and national legislation, regarding the effective (application for as long as recommended) and safe use of the product,
- Fresh solution of sodium hypochlorite with a concentration of 0.1-0.5% (1000 ppm – 5000 ppm of available chlorine) for at least 1 minute , depending on the space, the desired level of disinfection and the procedures of the sanitary unit.
- In case the initial concentration of sodium hypochlorite is 5%, the final concentration of 0.1% (1000 ppm of available chlorine) is achieved with a dilution of 1:50 (20ml: 1000ml). Respectively the final concentration of 0.5% (5000 ppm of available chlorine) is achieved by diluting 1:10 (100ml: 1000ml).
- In case the initial concentration of sodium hypochlorite is different from 5% the calculation of the required dilution for a final concentration of 0.1% – 0.5% (1000 ppm – 5000 ppm of available chlorine) is obtained with the following formula:
- Ethanol-based solution, in a concentration of 70-80%, for at least 1 minute, especially for surfaces that are likely to be damaged by the use of sodium hypochlorite or some other disinfectant.
4.3. During hospitalization of a suspected or confirmed case of COVID -19 infection
- Ventilated areas, where patients with possible or confirmed COVID-19 infection are treated, should be adequately ventilated and their door kept closed at all times.
- The patient’s main hospital and isolation room should be cleaned at least once a day. Cleaning should start in the cleanest areas and end in the dirtiest.
- It is recommended that the cleaning equipment be disposable or exclusive. Disposable cleaning equipment (which is disposable) must be treated as contaminating waste. If the cleaning equipment (eg cleaning cloths) is not disposable, it must be cleaned and disinfected after each use.
- In case of leakage or spillage of biological fluids on a surface, the surface must be cleaned immediately with the usual procedure of the sanitary unit.
- Toilets, sinks and toilets in general should be carefully cleaned and disinfected to avoid splashes.
- Frequent cleaning and disinfection (at least 2 times a day) of frequently touched surfaces (eg knobs, keyboards, etc.) is recommended.
4.4. After the discharge of a confirmed case for COVID -19 infection
- After the patient leaves the hospital, a general cleaning of the ward should be performed, after the room is adequately ventilated (according to the recommendations of paragraph 4.1.).
4.5. Medical equipment
- The use of disposable medical equipment is recommended where possible.
- In case the medical equipment is not disposable, the use of exclusive equipment for the care of patients with COVID-19 infection is recommended.
- In case the medical equipment used is reusable and used:
- exclusively for the care of patients with confirmed COVID-19 infection, to be cleaned and disinfected according to the procedures of the health unit (always taking into account the multi- resistant pathogens that may coexist with the SARS-CoV-2 virus)
- for the care of other patients (excluding patients with confirmed COVID-19 infection), to be cleaned and disinfected after each use in a patient with possible or confirmed COVID-19 infection .
4.6. Bed linen, towels, curtains and clothing
- Used bedding, towels, curtains and clothing should be placed in a bag according to infectious clothing procedures.
- The clothes should be washed in the washing machine at a temperature (60 ο -90 ο C) using detergent. If the nature of the fabric does not allow the use of high temperature, bleach or other suitable fabric disinfectant should be added to the wash.
4.7. Waste management
- All waste / waste from the care of patients with possible or confirmed COVID-19 infection should be treated as infectious hospital waste and managed in accordance with the procedures of the health facility and national legislation.
4.8. Cleaning staff and personal protective equipment
- Cleaning and disinfection must be performed by qualified personnel, trained in the use of personal protective equipment and in particular in its proper selection, application, use, removal and disposal.
- The required personal protective equipment for cleaning staff includes:
- For areas that are not handled that produce aerosol
- Surgical mask or mask of high respiratory protection FFP2 / Ν95 / ΚΝ95 if available (always taking into account exposure factors such as: the presence or absence of a patient in the room, if there has been adequate ventilation, etc.)
- Waterproof robe
- Eye protection (goggles or face shield), especially if there is a risk of splashing on organic material or chemicals
- Closed work shoes
- For areas that are handled that produce aerosol
- High respiratory protection mask FFP2 / FFP3 / Ν95 / ΚΝ95
- Waterproof robe
- Eye protection (goggles or face shield), especially if there is a risk of splashing on organic material or chemicals
- Closed work shoes
- Hand hygiene should always be followed after cleaning, disinfecting and disposing of personal protective equipment: washing with soap and water for at least 20 seconds or, if this is not possible, using an antiseptic solution containing 60-95% ethanol.
- For areas that are not handled that produce aerosol
In November 2017, IFS revised the version 6 to version 6.1 The expected version 7 of IFS Food has been postponed until the end of 2018.
With this change, the standard meets the benchmarking requirements of the GFSI and will remain a GFSI reference standard. The main changes in version 6.1 focus on the following topics:
- New requirements about food fraud
- Revision of the requirement about allergens management
- Integrity Program procedures were adopted to the rules valid since 01st May 2017
- Mandatory inclusion of QR-codes on the IFS certificate to trace its authenticity
Changes for the certified organizations
A new requirement was added to IFS version 6.1. The new paragraph 4.21 Food Fraud requires the following from food organizations:
A) a documented food fraud vulnerability assessment that will take into consideration all raw materials, ingredients, packaging and outsourced processes.The basic objective of this assessment is the determination of risk level in finished products from fraudulent acts (fraud, substitution of ingredients, incorrect labeling, etc.) with the aim of economic benefit and deception of the consumer.The criteria considered within the vulnerability assessment shall be defined.
B) a documented food fraud mitigation plan. Specific control methods and criteria should bedefined and implemented C) the documented food fraud vulnerability assessment and food fraud mitigation plan shall be reviewed in the event of increased risk (e.g food fraudincidents) or at least annually.
This requirement (4.20 Allergens and specific conditions of production) defines that organizations based on hazard analysis and assessment should take measures from receipt to dispatch to ensure that the risk of allergenic substances originating from cross contamination is reduced. These control measures should be verified.
Implementation of IFS version 6.1
The version IFS 6.1 will come into force on July 1st, 2018. For Companies which are audited unannounced applies the following:
- If audit period starts on or after July 1st, 2018 the company will be audited against IFS Food 6.1.
- If audit period starts before the 1st of July, 2018 the company has to be audited against IFS Food 6 April 2014.
As consumers and government bodies continue to demand more in terms of food safety and transparency, it’s never been more important for those in the food manufacturing and processing industry to become certified. But what exactly does this mean? In the US, there are hundreds of organizations that inspect, test and certify food products based on strict standards set out by religious organizations and the U.S. government. Though different certification processes can be lengthy and costly, the benefits of being certified are often too valuable to ignore. A recent study conducted by the Organic Trade Association, for example, found that organic sales grew from $3.6 billion in 1997, to $43.3 billion in 2015. In 2015, the organic industry experienced a 10.8% growth rate, which is well above the overall food market at 3.3%. As interest in organic and other certifiable foods continues to increase, it’s important to take advantage and get certified. Below, we outline the various certifications available for US food companies and how you can go about getting your product to market accurately and in compliance with FDA and USDA standards.
In August 2013, the FDA issued a final rule that set a gluten limit of less than 20 ppm (parts per million) in foods that carry this label. “This is the lowest level that can be consistently detected in foods using valid scientific analytical tools. Also, most people with celiac disease can tolerate foods with very small amounts of gluten.” In addition, the FDA also rules that food labeled as “without gluten,” “free of gluten” and “no-gluten” must also be held to the same standard.
While the FDA doesn’t specifically endorse any third-party gluten-free certification programs, there are many to choose from. The Gluten-Free Certification Program states that over 100 million North Americans are currently buying gluten-free products. The program goes onto explain that by becoming gluten-free certified, “companies can benefit from the gluten-free market and its exponential growth by communicating their commitment to producing safe, reliable and trusted gluten free products for consumers.”
Organic certification in the US is regulated by the National Organic Program (NOP), a division of the United States Department of Agriculture (USDA). In order to be considered organic, a product must be produced and processed using only handling and processing methods approved by the USDA. “These methods integrate cultural, biological and mechanical practices that foster cycling of resources, promote ecological balance and conserve biodiversity.” Only products that have been certified by the USDA may carry the USDA Organic Seal.
There are four different levels or organic claims recognized by the USDA:
- 100% Organic
- “Made With” Organic
- Specific Organic Ingredients
To begin the organic certification process, visit the USDA’s website.
A GMO, or genetically modified organism, is a plant, animal, microorganism or other organism whose genetic makeup has been modified at the DNA level. This creates unstable combinations of plant, animal, bacterial or viral genes that do not occur in nature. Deeming something non-GMO certified has become a highly-contested issue, largely due to the fact that the FDA has recently suggested that there is not enough evidence to show that foods derived from non-genetically modified plants differ from those derived from genetically modified ones in any meaningful way. The FDA also explained that there is not enough evidence suggesting that genetically engineered food presents greater health or safety concerns than food developed by traditional plant breeding. In terms of labelling and becoming non-GMO certified, the FDA’s guidance on the issue cautions against using terms like “free,” “does not contain GMOs” or “non-GMO” because of the difficulty of substantiating such claims. Although the FDA does not indicate whether it intends to enforce this, approximately 80 bills have been introduced in state legislature demanding special labelling for foods containing GMOs. The FDA does not require any special labelling at this time.
While non-GMO labelling is not required, annual sales of non-GMO verified products now exceeds $16 billion, and a 2014 consumer survey conducted by the Non-GMO Project found that 80% of consumers seek out non-GMO products.”
Before beginning the certification process, it’s important to understand the various requirements and standards your product and facility will be held to going forward. While every certification will vary in terms of these requirements and standards, the necessary functionalities and data management elements will not. Some of these functionalities include:
- Recipe management
- Ingredient formulation
- Quality management
FSMA regulations require most in the food and beverage industry to have a written food safety plan. Among other important elements, the food safety plan must contain a written hazard analysis and written preventative controls. Why is this important to an allergen control plan? Because federal regulations identify cross-contact of food allergens as a chemical hazard. Practically speaking, this means if you operate a facility that has both allergen-containing and allergen-free products, or allergen-containing products with different allergens, you have a cross-contact hazard. This hazard should be identified in your hazard analysis and a preventative control should be put in place. That preventative control will be your allergen control plan.
All preventative controls, including allergen control plans, must be in writing and must provide assurances that the applicable hazard (in our case allergen cross-contact) will be significantly minimized or prevented. When writing food allergen controls, you should consider the three Ps — procedures, practices, and processes — to control food allergens.
The goal is to control procedures, practices, and processes to prevent allergen cross-contact. This means that during storage, handling, and use of food products in the facility, reasonable steps are taken to prevent cross-contact and to prevent undeclared allergens from getting into products. This starts by forming an allergen-control team, or identifying an allergen-control captain to lead the efforts. The team should be familiar with the ingredients and products in the facility, the processes that take place there, and the sanitization requirements for the facility’s equipment. They should be empowered to propose alternative processes to prevent allergen cross-contact, and to review and analyze existing procedures to make sure they are maximally effective. In terms of practical controls, preventing allergen cross-contact starts by knowing what is in ingredients. An important first step is getting supplier verifications regarding the allergens that are in the ingredients they supply. Make sure any allergens present in an ingredient are conspicuously labeled. Color-coded labels can be an effective means to indicate the presence of an allergen. When storing ingredients, do your best to segregate allergen-containing ingredients from allergen-free ingredients. If separate facilities are not available, try separate store rooms/coolers. If that is not an option, take common sense steps, such as putting allergen-containing ingredients on the bottom shelf so that they cannot spill into anything else and making sure containers stay clearly and safely sealed.
When producing food, allergen controls should prevent as much overlap as possible between allergen-containing and allergen-free products. Where available, allergen-free products should be run on a separate production line where no allergen-containing ingredients are introduced. If an allergen-free line is near an allergen-containing line, physical barriers (i.e. a wall) should be erected to separate them and separate ventilation systems may be appropriate to avoid airborne cross-contact. Where separate lines are not possible, changeovers should be limited as much as possible. In other words, run as many allergen-free products as you can before running allergen-containing products, and then run as many allergen-containing products as you can. Sanitization should be scheduled for immediately after the completion of an allergen-containing run.
Besides segregated product runs, you can minimize cross-contact risk with reasonable employee and equipment controls. For example, tools, containers, and utensils used to handle a particular allergen or ingredient containing an allergen should be clearly marked and easily identified. Think of a purple handle for anything coming in contact with peanuts, for example. Employees who work on product runs which contain allergens should be restricted from working on products that are allergen-free. Where this is not possible, extra sanitization should take place between runs, including a change of uniform, hairnet, smock, etc. Allergen-free apparel should be colored differently than that worn when processing allergen-containing products.
Consider traffic patterns in your facility as part of your allergen control plan. Allergen-containing ingredients should be stored as close as possible to the allergen-containing production line to minimize cross-contact with other products. Likewise, employees should not be going from one line to the other without proper sanitization procedures. These controls will help “significantly minimize” the allergen cross-contact hazard in your facility.
The second component of an allergen control plan deals with the labeling of finished food products. A discussion of food labeling requirements, including the vagaries of “advisory labeling,” could go on for pages. Of importance to your allergen control plan is ensuring products are not “misbranded” pursuant to the Federal Food Drug & Cosmetic Act. A product is misbranded where it contains an undeclared major allergen. Taking the steps discussed above will help reduce the likelihood of allergen cross-contact occurring in your facility, and thus will reduce the likelihood that an undeclared allergen will make it into your product.
Like everything else, the effectiveness of an allergen control plan will depend largely on staff training and education. Let staff know the risks — and legal liabilities — of an undeclared allergen to a consumer with a serious food allergy. Provide staff training on allergen awareness and control for all employees at all levels of the company, at least annually. Specific training should also be provided to employees whose job duties would put them at greater risk of an allergen cross-contact incident. All training should be documented so it is known who has been trained and when training should be renewed. While there is no way to completely eliminate any risk of allergen cross-contact, provisions like those discussed above will help to significantly minimize the cross-contact hazard, as required by FSMA’s food safety plan regulations.
There is some confusion over Hazard Analysis and Critical Control Points and the more-recent food-safety plan, Hazard Analysis and Risk-Based Preventive Controls. Here are the key differences.
Both Hazard Analysis and Critical Control Points (HACCP) and Hazard Analysis and Risk-Based Preventive Controls (HARPC) are discussed, almost interchangeably, albeit incorrectly, in food-processing circles. The truth is that if you were to ask most food processing professionals to explain the differences between the two, the answer may not come so easily.
HACCP is a global standard, developed in the late 1950s and early 1960s by a team of engineers and scientists from three distinctly different organizations. Pillsbury, the Army’s Natick Research Labs, and the National Aeronautics and Space Administration (NASA) joined forces to draft and adopt a global, food-safety standard in keeping with, and as part of, the Codex Alimentarius. The Codex commission was established by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) in 1963. HACCP was originally developed as a way to ensure built-in quality and food safety, specifically for the manned space program, though it has evolved greatly since that point in time.
HACCP’s evolution has been continual, resulting in an effective and efficient, comprehensive food-safety management system (FSMS). Pillsbury publicly presented the HACCP concept at the 1971 National Conference on Food Protection, jointly sponsored by the Food and Drug Administration (FDA) and the American Public Health Association (APHA). In 1974, the FDA incorporated its concepts into its low-acid and acidified-food regulations. By the end of the 1980s, McDonald’s started requiring all of its suppliers to adhere to HACCP in order to ensure the safety of the food being served in its restaurants. Spurred by the marketplace, rather than legislation or regulation, other large companies followed suit and HACCP became the standard by which to measure food safety.
In 1989, the National Advisory Committee on Microbiological Criteria for Foods (NACMCF), published the first official HACCP document, standardizing the practice and presenting the seven principles of HACCP: (1) Hazard Analysis, (2) Critical Control Point Identification, (3) Establishment of Critical Limits, (4) Processes for Monitoring, (5) Corrective Actions (6) Record Keeping, and (7) Establishment of Verification Procedures . The rest, as they say, is history.
Moving forward, HARCP is not a global standard, but an updated U.S. standard incorporated into the Food Safety Modernization Act (FSMA) on July 4, 2012. Whereas HACCP generally applies to low-acid, canned food, juice, and seafood processors, HARPC applies to almost all food-processing facilities. The only facilities not required to comply with HARPC are those subject to the Standards of Produce Safety, those already governed by HACCP, and those facilities regulated by Good Manufacturing Practices (GMP) for Dietary Supplements. Small and very small business entities, as defined by the FDA are also exempt.
- HARPC mandates that facilities:
- Conduct a thorough hazard analysis for all food-processing procedures
- Develop and implement preventive controls, and then monitor the controls’ effectiveness
- Provide a detailed plan in writing, describing how the hazards will be controlled, the preventive controls put in place, and a schedule and methodology for monitoring the efficiency of the controls
- Verify the effectiveness of the controls, also maintaining written records of the verification processes
- Reanalyze the HARCP plan at least every three years; more often as new product lines are added, equipment is changed or upgraded, and/or when other changes require a new analysis
Finally, unlike HACCP, HARPC includes planning for potential terrorist acts and/or intentional adulteration and food fraud. A facility’s HARPC, food-defense plan should include additional security, such as visitor access and control.To put it even more simply, if you have an effective HARPC plan in place, you are also in compliance with HACCP mandates. If, however, you currently function under HACCP guidelines, it is your responsibility to determine if you must comply with HARPC under FSMA.