Wednesday, December 30, 2020

ISO 22000:2018 Allergen Management

ISO 22000:2018 Allergen Prevention Requirements  

ISO 22000:2018 standard has only mentioned allergens on one occasion, where it tries to explain food safety hazards, since ISO 22000 considers allergen as a chemical hazard which includes allergens and radiological substances (3.22, note 2 for entry: Food safety hazards include allergens and radiological substances). Thus, the ISO 22000 standard has completely relied on its prerequisite programs to consider non-process preventive measures while considering process allergens to be considered in the category of significant food safety hazards. Hence, ISO 22000:2018 broadly consider allergen as a chemical hazard, without offering specific concerns or program requirements considered in private label standards such as SQF or BRC. However, one of ISO 22000 sister standards or the technical specification, ISO 22002-1:2009, specifies requirements for establishing, implementing, and maintaining an allergen management program. This program is prepared based on the scientific approach of risk analysis, the HACCP principles, by assessing allergen hazards. Thus, food manufacturers that have implemented their food safety systems in alignment with ISO 22000:2005 have already taken actions towards managing allergens as it is a prerequisite program required by the international standard, but the new classification of process preventive controls and non-process preventive controls has been introduced in the current version of ISO 22000:2018, which has created two types of actions base on the allergen cross-contact or intentional addition to the existing processes.  

 

Hence, an effective allergen management program depends on the physical segregation of allergenic foods and ingredients from all other products and ingredients at every step of the food production process, which starts from receiving raw materials to delivery of the final product. In addition to the elimination of unintentional presence of allergens in food products, education, and training of the staff on food allergen risks, management and communication must be a top priority for food manufacturers. The most applicable method is the declaration of allergens present in the product, either by design or by potential manufacturing cross-contact, which must be accurately indicated on labels for consumer products, or the accompanying documentation for products intended for further processing. Consequently, public health relevant to food allergies continues to grow, where the food industry has boosted its efforts to maintain the management of food allergens. Nonetheless, national legislations that regulate the labeling of food allergens in many countries, other international standards, and voluntary guidelines have been developed to help organizations effectively prevent food allergen incidents.   

    

Food Allergies 

Food allergies are the inappropriate immune responses generated due to constituents in the foods that are mostly protein substances causing allergic reactions when the same food is eaten again. There are many different types of allergic responses, but the primary concern in food allergen management is primarily focused on the greatest impact over humans or animals, where the immune system produces IgE antibodies to proteins in the food. Nonetheless, food allergy must be differentiated from food intolerance, such as lactose intolerance, which does not involve the immune system responses.

 

Food allergic reactions can be varied from very slight to severe impacts and occasionally fatal, depending on the dose and the individual as well as other factors, which affect a greater proportion of children than adults. The reactivity to some allergenic foods, such as milk and egg, tends to be largely outgrown, while allergy to others, such as peanuts, generally persists. When an IgE-mediated reaction occurs due to a constituent of food inside the body, a rapid release of chemicals such as histamine may occur resulting in symptoms within minutes, but occasionally it may take up to 2 or more hours after ingestion of the offending food. However, a severe systemic reaction may occur in rare cases, leading to a sudden drop in blood pressure, severe constriction of the airways, a generalized shock reaction, and multiple organ failure, which is known as an anaphylactic shock that can lead to death within minutes if not treated with adrenaline. There is a small number of people in each community with such risk of food allergies with serious reactions, and many documented cases of death resulting from accidental ingestion of an offending food. 

 

Presently, all the internationally recognized food standards require (all or some of) peanuts, tree nuts, milk, eggs, lupin, sesame seeds, fish, shellfish, crustaceans, soy, celery, mustard, Sulphites, and cereals (wheat, rye, barley) to be declared on labels whenever they are present as ingredients or as components of food additives or processing aids. Australia and New Zealand, the United States, the European Union, Canada, Japan, and other countries have similar requirements for these and other known food allergens, but the US considers big 8 allergens and the EU has 14 declared allergens while Canada has 13 priority allergens.  

 

Food allergies affect around 10% of children up to the age of 1, between 4 – 8% of children aged up to 5 and approximately 2% of adults, and hospitalization for severe allergic reactions/anaphylaxis have doubled over the last decade, where there is a five-fold increase for children aged between 0 to 4 years over hospital admissions. On the other hand, food allergies affect around 2 to 4% of the population in Europe, and an estimated 5-8% of children, where there is an estimated 10-20 million people suffer from food allergies in the 500 million population of the 27 EU Member States, who believe they have a food allergy is considerably higher at around 20% of the same population. Many children outgrow their allergies, such as those to milk and eggs by the age of 5-7 years. Other allergies, such as to fish and peanuts, tend to persist. Nonetheless, there is no practical cure exists for food allergy and allergic consumers must avoid foods that contain the ingredient(s) to which they are allergic. Hence, individuals with allergic conditions must rely on the information provided on the label to determine whether the ingredients include food that may be allergenic.

 

As for food recalls information, approximately 37% of food recalls occurred in Australia from 2008 to 2017 were due to undeclared allergens in the final product and 2% were due to mislabeling, where many foods recall still occur due to the incorrect labeling of allergens contained in the food. Hence, the common causes of these recalls can include changes in product formulation or changes in a supplier’s ingredient formulation.

 

Furthermore, oral allergy syndrome (OAS) is a form of food allergy in which people become allergic through inhaling pollen proteins (fruit and vegetables) and then react to similar proteins in foods, where the symptoms can only be felt by the allergic person, but severe reactions are extremely rare. The development of a food allergy or any other allergy depends on complex interactions between a person’s individual susceptibility and factors related to exposure and the circumstances in which it occurs. Besides, children born to allergic parents are more likely to become allergic themselves, as well as most food allergies, begin in childhood, but onset can also take place later in life.
 

Coeliac disease is considered as an adverse reaction to foods involving the immune system, which is an immunologically mediated, non-IgE reaction to gliadin, a prolamin (gluten protein) found in wheat, and similar proteins found in the crops of the genus Tritiaceae (barley, rye). Coeliac disease is considered an autoimmune disorder of the small intestine that occurs in genetically predisposed people of all ages from middle infancy onward. The symptoms include chronic diarrhea, failure to thrive at a young age, and fatigue, where longer-term impacts include osteoporosis and other severe health effects have been reported. 

 

Food intolerance refers to adverse reactions to foods, which do not involve the immune system and are not usually the result of inherent toxicity. However, food intolerance has some characteristic of the food involving pharmacological activity to the affected individual such as enzyme deficiency or the cause is sometimes unknown, which is not usually immediately life-threatening, but such reactions can make the sufferer feel extremely unwell and can have a major impact on working and social life. They may occur very rapidly and mimic an allergic reaction, or can develop over many hours until the offending substance has been removed, e.g. lactose intolerance.

 

The allergic reactions start with the recognition of the allergen constituent (protein), where any process that modifies the structure of a protein will have the potential to affect allergenicity. Thus, food processing is usually a rigorous process that induces several physicals, chemical, and biochemical changes, and nonetheless, certain methods may enhance, reduce, or eliminate the allergenic potential of food while potentially impact the allergenic potential of proteins. 0n the other hand, processing can be used to remove the protein fraction of the food that reduces the exposure to allergens to prevent allergic reactions, e.g. highly refined seed oils. Such foods have granted exemptions in the labeling legislation, but there are no general rules regarding how different allergenic foods respond to physical (thermal, mechanical), chemical, or biochemical processing methods. Consequently, if there is no sound evidence that a specific processing method reduces allergenicity, it should be assumed that the allergenic potential of processed food is identical to that of the food in its unprocessed form.


References:

ISO 22000:2018

https://www.fooddrinkeurope.eu/uploads/press-releases_documents/temp_file_FINAL_Allergen_A4_web1.pdf

https://multimedia.3m.com/mws/media/1648172O/food-safety-anz-edm-allergen-control-plan.pdf

https://erudus.com/14-major-food-allergens-for-eu-food-information-for-consumers/

https://www.iso.org/obp/ui/#iso:std:iso:ts:22002:-2:ed-1:v1:en

 


Monday, December 14, 2020

Common Foodborne Pathogens - X

Noroviruses Risk Profile 
Norovirus (NoV), or the winter vomiting bug, is the most common cause of gastroenteritis, which is characterized by non-bloody diarrhea, vomiting, and stomach pain. Noroviruses are environmentally hardy organisms that can be transmitted by food, water, and also can be easily transmitted through person-to-person contact or contact through environmental surfaces. The norovirus infection can infect the same person several times because there are many different types of noroviruses. Thus infection with one type of norovirus may not protect against other types, which is possible to develop immunity to (protection against) specific types and, it is not known exactly how long immunity lasts. Nonetheless, whether you are susceptible to norovirus infection or not is also determined in part by an individual’s genes.
 
NoV is a genetically diverse group of single-stranded positive-sense RNA, non-enveloped viruses belonging to the family Caliciviridae, which can be genetically classified into at least seven different genogroups (GI, GII, GIII, GIV, GV, GVI, and GVII), and further divided into different genetic clusters or genotypes. The strains are known to cause disease in humans, which exist primarily in genetic clusters within genogroups I, II, and IV, whereas the viruses belonging to the other genogroups have been shown to infect other animals such as cattle, swine, and mice. Norovirus in genogroups GI and GII alone can be divided into at least 15 genetic clusters. Thus, a genetic cluster of NoV is defined as strains that have at least 80% homology to a reference strain’s amino acid sequence. 
 
Sources 
The major source of NoV outbreaks have been associated with the drinking of contaminated water, including municipal water, well water, stream water, commercial ice, lake water, and swimming pool or recreational surface-water exposure, as well as floodwater. The second most implicated source was salad ingredients, fruit, and oysters are the foods most often implicated in norovirus outbreaks. However, any ready-to-eat food that has been handled by an ill food worker may be contaminated. Molluscan shellfish, particularly oysters, have been commonly identified in NoV-related gastroenteritis outbreaks worldwide. However, this represents a different etiology that does not necessarily involve a contaminated food worker. The rapid spread of secondary infections is particularly evident in areas where a large population is enclosed within a static environment, such as in institutions, college campuses, schools, military operations, hotels, restaurants, recreational camps, hospitals, nursing homes, day-care facilities, and cruise ships, and after natural disasters, such as hurricanes and earthquakes. Nonetheless, nearly 29% of all NoV foodborne outbreaks from 1997-2004 could be attributed to food purchased or served at a restaurant or delicatessen.
 
Disease 
Norovirus infections occur more commonly during winter months, which is often occur in outbreaks, especially among those living in close quarters, which are a leading cause of foodborne infection in the United States. 
 
Mortality
The infections approximately account for 26% of hospitalizations and 11% of deaths associated with food consumption. 
 
Infective dose
The infective dose is considered very low, which is estimated to be as low as 1 to 10 viral particles. The viral particles are excreted at high levels as high as 1 x 1012 million viral particles of 1g feces by both symptomatic and asymptomatic people. 

Onset
Mild, brief symptoms usually develop between 24 and 48 hours after contaminated food or water is consumed, but onset times within 12 hours of exposure have been reported.
 
Complications
Norovirus infection is self-limiting, which can be very debilitating as a result of the high rate of vomiting, where recovery is usually complete without evidence of long-term effects. The most common complication is dehydration, particularly among the very young, the elderly, and patients with underlying medical conditions, where no specific therapy exists for viral gastroenteritis or NoV infection. Treatment for NoV infection is consisted primarily of oral rehydration and, if needed, intravenous replacement of electrolytes. There is no antiviral medication or vaccine is available, and antibiotics are not effective for treating NoV infection. Prevention involves proper hand washing and disinfection of contaminated surfaces, and alcohol-based hand sanitizers can be used as an alternative, but they are less effective than hand washing. There is no vaccine or specific treatment for norovirus, where management involves supportive care, such as drinking sufficient fluids or intravenous fluids.
 
Symptoms
Explosive, projectile vomiting usually is the first sign of infection and is often used to characterize the infection. Symptoms usually present as acute-onset explosive often vomiting, watery, non-bloody diarrhea with abdominal cramps, and nausea, headache, low-grade fever, chills, and muscle aches may also occur. Thus, the severity of symptoms appears to be higher in hospitalized patients, immunocompromised people, and elderly people, compared with younger adults and other groups. Nonetheless, there is about 30% of people infected with NoV display no gastrointestinal illness or associated symptoms, though they are still excreted high levels of virus in their stool, and such distinctive groups of people are considered to be silent shedders of NoV. 

Duration
Symptoms generally persist for 12 to 60 hours, with a mean period of 24 to 48 hours, where most patients report feeling better within 1 to 2 days. However, immunocompromised or elderly people and hospitalized patients may retain symptoms as vomiting and diarrhea continue for a while, and generally resolve within 72 to 96 hours, where the non-specific symptoms, such as headache, thirst, and vertigo, could persist up to 19 days.
 
Route of entry
Though the virus is usually spread by the fecal-oral route, foodborne norovirus infections have been epidemiologically linked into three distinctive segments:  
Cases associated with the consumption of ready-to-eat (RTE) foods contaminated by food workers; 
Environmental contamination of produce; 
Consumption of molluscan shellfish harvested from contaminated water. 
In rare cases, transmission can occur through vomit and is often associated with improper sanitation controls or their application. Secondary transmission following the foodborne illness is common, due to the high levels of virus that are excreted. 
 
Pathway
Norovirus infection causes gastroenteritis, an inflammation of the stomach and the small and large intestines, but the precise pathogenic pathway of infection is unknown. 
 
Frequency 
Norovirus infections annually result in about 685 million cases of disease and 200,000 deaths globally, which is common both in the developed and developing worlds. Infants under the age of five are most often affected, which results in about 50,000 deaths in the developing world. According to the Centers for Disease Control and Prevention (CDC) estimates that noroviruses cause 5.5 million infections annually in the United States with an estimated range of 3.2 million to 8.3 million cases of foodborne infections, which accounts for 58% of all foodborne illnesses, including approximately about 0.03% (14,663) require hospitalization, and less than 0.1% of these illnesses results in death (149). 
 
Diagnosis 
Clinical diagnosis, without the diagnostic tests used to identify NoV-associated infections, include the following four criteria: 1) vomiting in more than 50% of affected persons in an outbreak; 2) a mean (or median) incubation period of 24 to 48 hours; 3) a mean (or median) duration of illness of 12 to 60 hours, and 4) lack of identification of a bacterial pathogen in stool culture. The clinical diagnosis of NoV infection is carried out using analytical tests on serum, stool, and in some instances, vomitus. Diagnosis also can be achieved by examining blood serum samples for a rise in virus-specific serum antibody titers, measured by enzyme immunoassay (i.e., ELISA or EIA). However, this method has had only a 55% level of accuracy when compared with a reverse transcription-polymerase chain reaction (RT-PCR) approach. The applicability of these assays is also limited by the requirement to collect stool specimens from acute or convalescent patients for accurate determination. Examination of stool specimens for norovirus can be performed by microscopy through direct electron microscopy or immunoelectron microscopy to visualize viral capsids, which requires high densities (generally >106 /g). Thus, RT-PCR is the preferred method of diagnosis since it is significantly more sensitive than microscopy; does not require a large, expensive electron microscope with highly skilled personnel; and has the ability to rapidly differentiate genogroups, which could be instrumental in follow-up epidemiologic investigations, to determine the route and distribution of NoV in the community. 
 
Target Populations 
NoV may impact people of any age, but it is more prevalent among the elderly and children under the age of 5. According to the research data, there is a genetic predisposition to acquiring an infection that is dependent on the patient’s blood type (ABO phenotype). Nonetheless, the previous infection of Norovirus does not provide long-term immunity, and reinfection by the same strain can occur several months after the initial infection. On the other hand, the rapid spread of secondary infections through congested areas where a large population is enclosed within a static environment, such as in institutions, college campuses, schools, military operations, hotels, restaurants, recreational camps, hospitals, nursing homes, day-care facilities, and cruise ships, or after natural disasters, such as hurricanes and earthquakes. 
 
Food Analysis 
Assays using RT-PCR technology for NoV detection and quantitation are commercially available, but quantitative RT-PCR (qRT-PCR) is the most sensitive method for NoV detection in food extracts, which is an improvement over conventional RT-PCR due to its increased specificity and sensitivity. NoV has been successfully detected and isolated from oysters, irrigation, and groundwater, as well as deli meats.
 
 
Reference:
FDA Bad Bug Book, Foodborne Pathogenic Microorganisms and Natural Toxins. Second Edition. 2013
Preventive Controls for Human Foods. 2016
www.cdc.gov