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Category: FSMA

COVID-19 Preparedness in the Food Industry

Thursday, 08 October 2020 by Dr Faour Klingbeil
On 11 March 2020, the outbreak of coronavirus disease (COVID-19) has been declared a global pandemic by the World Health Organization as the virus has spread to many countries. It’s the first time the WHO has called an outbreak a pandemic since the H1N1 “swine flu” in 2009. What is confirmed is that the virus is transmitted through direct contact with respiratory droplets of an infected person (generated through coughing and sneezing). Individuals can also be infected from and touching surfaces contaminated with the virus and touching their face (e.g., eyes, nose, mouth). Besides, the COVID-19 virus may survive on surfaces for several hours, yet disinfectants can kill it. On 9 March, the European Food Safety Agency (EFSA) stated on their website that there is currently no evidence that food is a likely source or route of transmission of the novel coronavirus, and that they are closely monitoring the situation as any new information about the outbreak comes to light. EFSA’s opinion is based on the fact that previous outbreaks of related coronaviruses, such as severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV), show that transmission through food consumption did not occur. BfR, the federal institute of risk assessment in Germany concurred with the findings, stating that there are currently no cases that have shown any evidence of humans being infected with the new type of coronavirus by another method, such as via the consumption of contaminated food or via imported toys. Transmission via surfaces which have recently been contaminated with viruses is, nonetheless, possible through smear infections. This is only likely to occur during a short period after contamination, due to the relatively low stability of coronaviruses in the environment. This virus is not SARS, it’s not MERS, and it’s not influenza. It is a unique virus with unique characteristics WHO Director General A recent review analyzed 22 studies and revealed that human coronaviruses such as Severe Acute Respiratory Syndrome (SARS) coronavirus, Middle East Respiratory Syndrome (MERS) coronavirus or endemic human coronaviruses (HCoV) can persist on inanimate surfaces like metal, glass or plastic for up to 9 days, but can be efficiently inactivated by surface disinfection procedures with 62–71% ethanol, 0.5% hydrogen peroxide or 0.1% sodium hypochlorite within 1 minute. Other biocidal agents such as 0.05–0.2% benzalkonium chloride or 0.02% chlorhexidine digluconate are less effective This is what we know “so far”. As the WHO Director-General stated “This virus is not SARS, it’s not MERS, and it’s not influenza. It is a unique virus with unique characteristics”, and scientists are working around the clock to address critical gaps in knowledge. In a recent study (US government work) conducted by the National Institutes of Health, Princeton University and the University of California, Los Angeles, with funding from the U.S. government and the National Science Foundation, Covid-19 was detected up to three hours later in the air, up to four hours on copper, up to 24 hours on cardboard and up to two to three days on plastic and stainless steel. Revise and update the health policy Having said that, while there is a lot of uncertainty in the situation, it is advisable that food processors evaluate the current practices inside their organization and manage staff who may be carriers or infected with the Coronavirus. Reviewing and updating the existing disease control/health policy while considering recent recommendations and requirements of the local authorities is paramount. Did you address in your your policies address any food to which an ill employee may have had exposure, including whether the policies address whether there are conditions present that would support a company decision to place food on hold pending advice from the public health authorities. Here are the CDC recommended strategies for employers to use which may help may help prevent workplace exposures to acute respiratory illnesses, including COVID-19. Many of the steps described in the CDC link are useful and apply to every food facility, yet as a food facility outside the US, you will refer to the guidance, updates and travelers’ health notices of local authorities to determine whether there are any local requirements to contact public health authorities in the event an employee in the workplace has been diagnosed with COVID-19 and to establish procedures for handling other employees who may have come in contact with the diagnosed employee. Top management should encourage employees with symptoms to stay home and get prepared for the sudden absenteeism and shortage of staff. Besides the disease control plan, precautionary hygiene measures are of significant importance. The World Health Organisation (WHO) has issued recommendations including advice on following good hygiene practices during food handling and preparation, such as washing hands, cooking meat thoroughly and avoiding potential cross-contamination between cooked and uncooked foods. Similarly, many local authorities such as in Belgium also emphasized those practices. As simple as this seems to be, translating messages into practices is not easy and often undermined with barriers that need to be understood. In practice, it requires instilling a hygiene culture to ensure the highest levels of hygiene measures, particularly when food processors may face the situation of operating with staff shortages and absenteeism. A hygiene culture in a way it does not require the staff to think much about it! it is a culture shared at all levels of the organization from top management to production staff. Have you included in your contingency plan re-evaluating your hygiene standards? The topic of today is focused on hand hygiene, which must not be overlooked in your Covid-19 training tool box. What have you done to highlight this issue in your organization? It would be great if you share your experience with others in the comment box. I am sharing some of the key messages you may like to consider to reinforce the hand washing practices: Hygiene Culture 1- Assign competent staff to stay aware of recent news and updates on the COVID-19 outbreak, how it is transmitted and how to prevent transmission. Information are available on the CDC, ECDC, WHO websites, and local health authorities.
  • Published in Covid-19, FSMA

Avoid the mistake of assuming HACCP and GFSI compliance will meet the FSMA requirements

Thursday, 08 October 2020 by Dr Faour Klingbeil
I have met recently with few representatives from the food industry and it appeared from our discussions that many were still unaware of the difference between the GFSI certification and FSMA compliance. For them, both equate, and the only steps required to export foods to the US market is to go through the registration process. There was some confusion about the mandatory requirement to develop and implement a Food Safety Plan (FSP) which was assumed to be the same as their existing HACCP plan, which is not the case. Certification to a GFSI-benchmarked scheme (BRC, SQF, FSSC22000, IFS, etc.) and having an HACCP plan do not make the food facility compliant with the FSMA Preventive Controls Rule, yet it does make it ready to reach compliance. While HACCP focuses on the determination of the Critical Control Points (CCPs) to prevent post-process contamination, under FSMA, the FSP goes far beyond the determination of the CCPs during processing to include risk-based preventive controls that are determined as critical elements in the sanitation and allergen control programs, and in the supplier chain program. The FSP must be created and overseen by a preventive controls-qualified individual (PCQI) and should be based on: 1- Hazard Analysis, identifying known or reasonably foreseeable biological, chemical, radiological and physical hazards 2- Documentation (written) of preventive controls including process controls, food allergen controls and sanitation controls, supply chain controls, and a recall plan 3- Documented implementation procedures which include monitoring the implementation of the preventive controls, corrective action, and verification procedures. To export foods to the US market, It is mandatory to develop the Food Safety Plan that is compliant with FSMA Preventive Rule, NOT with HACCP The difference between HACCP and GFSI compliance or to FSMA might not be practically easy to grasp without a PCQI training. Why it is important to train PCQIs? Under the FSMA rule, FDA is permitted to inspect domestic and foreign facilities (those based on non-US territories) at the times and in the manner permitted by the FD&C Act. As part of this, the FSP is inspected for its adequacy and any deficiencies or inadequacies identified means the PCQI (individual who developed the FSP) is not appropriately trained for the application of the risk-based preventive controls. The difference between HACCP / GFSI compliance and FSMA might not be practically easy to grasp without a PCQI training What may result out of this? In the event of having an inadequate food safety plan developed by unqualified staff, various scenarios are possible depending on the severity of the identified failure or if the food presents a threat of serious adverse health consequences or death to humans. Therefore, the FDA can take actions such as: suspension of the food facilities’ registration, product detention, issuing a warning letter and criminal charges and add to this the costly re-inspection visits. The cost for a foreign facility is $285 per hour. Ensuring the FSP is prepared and overseen by a trained PCQI is certainly an added value and crucial to avoid the above mistakes. To help the food industry complies with the requirements of the Preventive Controls rules, the Food Safety Preventive Controls Alliance (FSPCA) developed the FDA-approved standardized curriculum for training PCQIs.  As a PCQI Lead Instructor, I am offering public and in-house FSPCA certified PCQI training. For more information on locations and dates, please follow the link here and navigate the calendar. You are welcome to subscribe to the newsletter to keep you updated on the PCQI training that will be organized in Germany and selected countries in the MENA region for the year 2019.
  • Published in FSMA
Tagged under: FSMA, FSP, FSPCA, PCQI

How Does HARPC system differ from HACCP

Sunday, 26 April 2020 by Dr Faour Klingbeil
“What is the difference between the Hazard Analysis and Critical Control Points (HACCP) and the Hazards Analysis and Risk-Based Preventive Controls (HARPC)?” is a question we often hear from professionals working in the food industry and expected to be raised more often having been involved in managing the food safety systems based on the HACCP concept which is universally accepted by government agencies, trade associations and the food industry around the world ( NACMCF, 1997). HACCP is based on the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product in order to reduce the risks of safety hazards in food. It is based on 7 principles: Principle 1: Conduct a hazard analysis.Principle 2: Determine the critical control points (CCPs).Principle 3: Establish critical limits.Principle 4: Establish monitoring procedures.Principle 5: Establish corrective actions.Principle 6: Establish verification procedures.Principle 7: Establish record-keeping and documentation procedures The HARPC is based on these same basic food safety principles; more specifically, it recognizes the importance of hazards analysis and setting critical limits to monitor the control points; it emphasizes the corrections/corrective actions, verification activities and the recall plan. The preventive approach is not recent, it dates back to the 60’s when the HACCP was pioneered by the Pillsbury corporation to ensure food safety for the first manned National Aeronautics and Space Administration space missions. NASA’s main concerns were to ensure safe food for astronauts. The WHO Europe recommended the system in 1983 and the Codex released the first HACCP Guidelines which was revised in 2001 and adopted by the FAO/WHO Codex Alimentarius Commission. The U.S.National Advisory Committee on Microbiological Criteria for Foods (Committee) reconvened a Hazard Analysis and Critical Control Point (HACCP) Working Group in 1995. The primary goal was to review the Committee’s November 1992 HACCP document, comparing it to current HACCP guidance prepared by the Codex Committee on Food Hygiene. The Committee again endorses HACCP as an effective and rational means of assuring food safety from harvest to consumption. NACMCF issues the third revision document in 1997. Basically, the HACCP was integrated into the official regulations in the European Union and the United States. For instance, the U.S. Food and Drug Administration adopted HACCP in low acid canned foods, then the FDA mandated HACCP for seafood products and in 2001 for juice processors. The Council Directive no. 91/493/EEC places the responsibility of product safety on the industry as it introduced the concept of ‘own checks’ and Critical Control Points during processing and the Commission Decision 94/356/EEC details the rules for the application of the HACCP system. The term HARPC goes back to 2011, when the Food Safety Modernization Act (FSMA) was signed into law by President Barack Obama. FSMA directs FDA to establish standards for adoption of modern food safety prevention practices by those who grow, process, transport, and store food. In 2015, FDA has finalized seven major rules to implement FSMA; the Hazards Analysis Risk-Based Preventive Controls for Human food is one of those 7 rules which is also referred to as The Preventive Controls for Human Food (PCHF). The Hazards Analysis Risk-Based Preventive Controls for Human food (HARPC) requirements specify that a facility must prepare, or have prepared, and implement a written food safety plan (FSP) (21 CFR 117.126). The elements of the FSP are (21 CFR 117.126(b)): Hazard analysis Preventive controls (see 21 CFR 117.135), as appropriate to the facility and the food, to ensure safe food is produced, Procedures for monitoring the implementation of the preventive controls, as appropriate to the nature of the preventive control and its role in the facility’s food safety system Corrective action procedures, as appropriate to the nature of the hazard and the nature of the preventive control Verification procedures, as appropriate to the nature of the preventive control The preventive controls approach to controlling hazards used in an FSP is developed based on the risk-based HACCP principles as described by the National Advisory Committee on Microbiological Criteria for Foods It is important to note that the preventive controls approach to controlling hazards used in an FSP is developed based on the risk-based HACCP principles as described by the National Advisory Committee on Microbiological Criteria for Foods. Therefore, there are similarities between the FSP and a HACCP plan and the similarities are in the essence of both systems; both adopt the preventive approach , yet there are few differences. Table 1 shows the different elements required in each of the plan and how they differ: In HARPC, A “hazard” is any biological, chemical (including radiological), or physical agent that has the potential to cause illness or injury. These include hazards that occur naturally, that are unintentionally added or that may be intentionally added to a food for purposes of economic gain (i.e., economic adulteration). Contaminants that have no direct impact on the safety of the products are considered “undesirable defects” and do not require a preventive control, hence they should not be included in the FSP. Once the hazards requiring preventive controls are identified in the Hazard analysis, the FSP should include documentation of the preventive controls that were determined as appropriate to controlling the hazards. The preventive controls include: Process controls Food allergen controls Sanitation controls Supply-chain controls Recall plan Other controls The CCP is a point, step or procedure at which controls can be applied and a food safety hazard can be prevented, eliminated or reduced to acceptable (critical) levels. In a HACCP plan, the CCPs are steps in the process that are always monitored, whereas in the FSP, not all preventive controls are CCPs (Process controls), hence the preventive controls are only monitored as appropriate to the nature of the preventive control and its role in the facility’s food safety system. That means some preventive controls that are not necessary applied at CCPs may not be monitored such as the supply chain preventive control and recall plan. The FSP incorporated the element “corrections” in addition to
  • Published in FSMA

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