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.…
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.
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.
“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: