The media channels have been flooded with the disturbing news of the Listeria outbreak. We took the opportunity to chat to Janusz Luterek, Attorney-at-law about the legal implications of this outbreak.
Implications of the Listeria Outbreak for the Industry
FF: News of this outbreak was first published in the public domain in September. SAAFOST have been circulating a request to custodian members to provide information of listeria testing and results to the National institute for Communicable Diseases in order to identify the source. Similarly the Director General of Health requested the CGCSA to appeal to their members to assist with providing information. In both cases anonymity has been assured. How does this work legally?
JANUSZ: This move is unprecedented and as such companies should take the opportunity to be transparent. This might be the last time you have this dispensation.
FF: Can the Department of Health not demand this information? Is that not a better approach?
JANUSZ: In the absence of any proof that a company is at fault, the Department have no legal mandate to demand. They can seize documents if they have evidence to support a suspicion of wrongdoing.
FF: But what if a company is not testing at all? What are the legal requirements pertaining to microbiological testing in South Africa.
JANUSZ: There is Regulation 692 of the Foodstuffs, Cosmetics and Disinfectants. This regulation provides specific microbiological standards relating certain acceptable levels of organisms Act, Act 54 of 1972. However this regulation does not provide an exhaustive list of all possible pathogens associated with the foodstuffs listed. Neither should it be interpreted as the only foods requiring testing.
Each manufacturer has to identify their own hazards, acceptable levels and make sure they are testing appropriately. Any person shall be guilty of an offence under section 2 of the FCD Act (b) if he sells, or manufactures or imports for sale, any foodstuff or cosmetic
(i) which is contaminated, impure or decayed, or is, or is in terms of any regulation deemed to be, harmful or injurious to human health; or
(ii) which contains or has been treated with a contaminated, impure or decayed substance or a substance which is, or is in terms of any regulation deemed to be, harmful or injurious to human health. So, it is up to you. You cannot claim you didn’t know just because the law does not specify listeria.
FF: Yes, agreed, and on the implementation of a food safety management system, this is why you are required to consider epidemiological data and hazards that may occur in the previous step of the food chain. So Listeria is associated with unpasteurised dairy products and meat products so this well documented information should prompt you to ensure your raw materials and final products are tested.
FF: Some people have said that all suppliers are testing their raw materials and final products. I think this generalisation is not a safe one as many smaller suppliers who may not supply national retailers may not be aware of all the food safety requirements. Is the Department of Health not mandated to monitor the safety of foods sold in South Africa?
JANUSZ: Yes you are correct but we both know the Department simply does not have the capacity to test. We cannot rely on them to ensure food safety in South Africa.
FF: How does this situation fit with the Consumer Protection Act?
JANUSZ: The CPA is put in place for all consumer products not just food products. This legislation is there to ensure the consumer is provided with safe quality products. So, any products supplied to the consumer which are potentially harmful would be illegal and could lead to liability to consumers.
FF: I see daily alerts of product recalls for listeria around the world. The CPA also addresses recalls. Should I consider a voluntary recall if my product is positive?
JANUSZ: Yes this is correct. The CPA addresses mandatory recalls similar to the Ford Kuga instance recently where the manufacturer is required to recall product at their cost. However a supplier should not wait for this.
" If you know your product is potentially harmful you should recall and not just from the retail shelves. You should be publishing your recalls to get it out of fridges and pantries – get it back from the consumer if the consumer is at risk. That is the right thing to do. Better to recover from a recall than to be found out."
FF: What about the patients affected? What recourse do they have?
JANUSZ: Persons affected, if they can prove they were infected with Listeria and where they got it, can have a claim against the retailer and its suppliers for all harm suffered including future loss of earnings, loss of support if someone died, etc - the consumer need not prove anyone was negligent! The difficulty is that the consumer only realised 21 days after they ate the food that they had Listeriosis and how would they draw the link back to the retailer/supplier? DoH have been unable to do this so far with all the resources of the country at their disposal.
FF: In this case the NICD has established that at least 70% of the cases are from the same Listeria monocytogenes genetic makeup. This information is from testing the isolates from the patients. Once the source is found, the Listeria in the product or facility can be tested and if the genetic make up is the same the proof will be available. So in the case of Listeria it is not as costly as it could be in my opinion, or as difficult.
FF: Does the publication of this information in the public domain change anything for suppliers and the retailers? Do you think new regulations will come out of this?
JANUSZ: yes definitely I can see levels of listeria being regulated which in light of this outbreak is a good thing. It may even go broader than that.
FF: What about a recall forum? Do you think this might be looked at more closely going forward? To ensure voluntary recalls are published?
JANUSZ: Voluntary recalls are the way to go. The supply chain is at risk of class action lawsuits if many consumers are harmed by a Listeria outbreak. A voluntary recall forum would go a long way to assist with disseminating recall information and improving efficiency of recalls.
FF: The collection of this data is therefore important over and above the outbreak as it will assist the DOH in determining levels of exposure in any event and be able to conduct a better risk assessment. As the industry we should be stepping up and providing the request information, implementing a robust environmental monitoring programme and not taking any chances with positive results for Listeria. We cannot allow any further deaths on our watch.
Additional Listeria Questions (13 December)
FF: How liable am I as the Food Safety Manager in a situation where we (the company) have caused harm or illness to a consumer?
JANUSZ: Unlikely to be liable, unless you were grossly negligent - the CPA would not reach through to such a person, but under the common law the person could have liability if they ignore company protocols and procedures and legal requirements they should have known about.
FF: Basically who will be fined, fired and go to jail if a case were to go further?
JANUSZ: Under FCD Act it would be the person in charge of the premises where the contamination occurred. In addition, under CPA it would be the company which gets a fine if it carried on a prohibited conduct under the CPA. It is possible for a responsible person, could be the CEO or another director or manager, to be liable with the company.
FF: I give advice to the best of my ability and experience but may be overruled by senior management. What do I need to prove myself not guilty in a serious case? Many times conversations are verbal and not on email or documents for obvious reasons. How will I be protected as a scientist from being bullied and overruled when the fire gets hot?
JANUSZ: If you are engaging in verbal discussions to avoid liability of putting in writing then you know you are wrong and you will have no defence because you will not be able to prove that you tried to do the right thing. Thus, communicate by email or otherwise in writing in all such cases so there is a record of what was said and by whom and when.
FF: Can the DOH compel labs to submit their results?
JANUSZ: Once the infection is diagnosed, then yes, but not as a fishing expedition. Also, if there is evidence (at least on the face of it) of a source of contamination then they should be able to request the analytical data or at the least take samples if there are none. Check R 962 the Hygiene Regulations, R328 The Powers of Inspectors, and the FCD Act itself on what documents can be requested and uplifted.
FF: What is your advice to companies who to date may not have been disclosing the full set of testing results to auditors, customers etc?
JANUSZ: If you are testing and the results are clear then there is no reason not to disclose to others in the supply chain, but I am wary of disclosing complex scientific results to the public who more likely than not are unable to give the proper interpretation to them. E.g. absence v low CFU's v high CFU's as a cause of illness.
Do you have further questions? Let us know and we will assist with answers where possible.
MAKE SURE TO WATCH THIS LISTERIA WEBINAR WITH JANUSZ
