The use of sanitation tunnels at schools in South Africa

The use of sanitation tunnels at schools in South Africa

Recently there have been some cases of companies proposing the use of sanitation or decontamination spray tunnels at school entry and exit points in order to reduce the spread of COVID-19. This paper tries to highlight some of the concerns around these proposals from a regulatory and scientific perspective.

At this stage it is unclear how these sanitation tunnels and the chemical substance dispersed within them will be regulated. In South Africa, there are various government departments which administer different acts, and so it will be necessary to understand which act and regulatory framework may be applicable for these products.

In terms of the Medicines and Related Substances Act 101 of 1965, administered under the Department of Health, medicines and related substances intended for human and animal use are required to be registered. The requirements for registration include assessments for safety, quality and therapeutic efficacy. There are, however, provisions in the Act that would enable the sale of an unregistered medicine during a specified period. A medicine is defined as a substance or mixture of substances used or purporting to be suitable for use in prevention of disease or symptoms thereof in man. The definition of a medical device includes any instrument, appliance or apparatus that is used or purporting to be suitable for use in the treatment or prevention of disease. It is possible, therefore that the substances applied in a sanitation tunnel may fall within the scope of the Medicines and Related Substances Act, and in which case they would require regulatory approval from the South African Health Products Regulatory Authority prior to use in schools.

In terms of the Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972, also administered under the Department of Health, a disinfectant is defined as any article or substance used or applied or intended to be used or applied as a germicide, preservative or disinfectant. In terms of this Act a person shall be guilty of an offence is he sells any disinfectant which does not comply with the standard of composition, strength, purity or quality prescribed by regulation or in respect of it or any standard so prescribed for.

In terms of the National Regulator for Compulsory Specifications Act, administered under the Department of Trade and Industry, Schedule VC 8054 provides The Compulsory Specification for Chemical Disinfectants which covers the requirements for chemical disinfectants used for disinfection purposes on inanimate surfaces in all areas of application. Therefore, it is clear that this specification will regulate the substances used to disinfectant environmental surfaces in the school which may be applied by various methods including spraying, wiping and fogging but there is no complusory or other standard for use on a surface other than an imanimate one, meaning that there are no provisions to provide a specification for products for use on or over humans.

In addition, the Standards Act 8 of 2008, provides for the development, promotion and maintenance of standardisation and quality and provides for the establishment of the Board of SABS (South African Bureau or Standards). SANS 490:2013 provides the standard for disinfectant alcohol-based handrubs, which states that “disinfectants for use on skin shall be registered with the Medical Control Council in South Africa”.

On 9 April 2020, the National Regulator for Compulsory Standards (NRCS), the South Africa Health Products Regulatory Authority (SAHPRA), and the South African Bureau of Standards issued a Joint Communication to Stakeholders on the regulatory status of equipment being used to help prevent COVID-19. It distinguishes between whether the product will be applied to an inanimate surface or human skin and the place of use. In this communication schools, restaurants and the like are classified as low risk whilst hospital operating rooms, burn units and intensive care units, are high risk. It provides that disinfectants for use on inanimate surfaces in low risk environments should be regulated by the Foodstuffs, Cosmetics and Disinfectants Act whilst disinfectants used on inanimate surfaces in high risk environments should be regulated under the Medicines and Related Substances Act. What is not clear or provided, is how a chemical product (sanitizer or disinfectant) which is to be used or applied in a spray tunnel directly over people or children, should be regulated. It is, in my view, something that falls within the scope of the Medicines and Related Substances Act and should require oversight by SAHPRA. Before these products are used in these sanitation tunnels, safety data needs to be assessed to ensure that the products are safe for this type of use.

On 15 May 2020, The World Health Organisation published an interim guidance document on cleaning and disinfection of environmental surfaces in the context of COVID-19. In this document they state firstly that at the time of publication, “transmission of the COVID-19 virus had not been conclusively linked to contaminated environmental surfaces”. Which is an important note considering the intensive efforts going in to decontaminating inanimate surfaces prior to the opening of schools. The guidance document goes on to differentiate between healthcare and non-healthcare settings such as schools. In non-healthcare settings, environmental surfaces include sinks and toilets, touchscreens, furniture, floors, stairways rails and walls. It is clearly stated that in order to be both safe and effective disinfectant solutions must be prepared and used according to the manufacturer’s recommendation for volume and contact time. The guidance document also states that it is not recommended to disinfect environmental surfaces within indoor spaces (such as classrooms) by spraying and fogging. Instead the recommendation is to clean the surfaces with soap and water, and then disinfect by wiping appropriately with a substance in accordance to manufacturers recommendation for usage and that the disinfectant must be carefully selected to avoid toxic effects on persons. Additionally, and most relevant here, the guidance document specifically highlights that “spraying individuals with disinfectants (such as a tunnel, cabinet or chamber) is not recommended under any circumstances” as this could pose physical and psychological risk to the person, and will not reduce an infected person’s ability to spread the virus through droplets or contact.

In order for these disinfectant products and proposed processes to be used safely in school environments, it will be necessary to conclude a human health risk assessment. This is recognized approach used to understand the human health effects of the substance. Basic risk assessment principles are based on a hazard and exposure calculation, where risk = hazard x exposure. The hazard describes the potential to cause harm while risk describes the probability of causing harm under defined circumstances. People may be exposed to chemicals in different ways, for example through the air, through consumption or through the skin. A human health risk assessment will evaluate the toxicity (or hazard) of a substance and the exposure to that substance. Risk assessors may consider different things when evaluating risks, but there are four key steps to every risk assessment. These are (1) hazard identification; (2) dose response assessment; (3) exposure assessment; and (4) risk characterization. The hazard identification considers what the properties of the substance are and what the health effects of those properties are. The dose-response assessment will look at the level or dose of the substance that causes any of the observed harmful effects. The exposure assessment considers how much people will be exposed to the hazard or substance and the risk characterisation will take into account the data on exposure and dose-response to ascertain what the risk profile is for the substance.

In the case of a disinfection or sanitation tunnel, the hazard is the chemical substance that will be sprayed or fumigated, and the exposure will relate to the concentration of the substance used, the duration and frequency of the child in the tunnel. It is easy to understand that a chemical substance designed for infrequent use on hands or a chemical substance designed for use on an inanimate surface may have been shown as safe for this specific use, but when used or applied directly on a person through a spray tunnel, the risk profile is likely to change. It would therefore be necessary to ensure that the product is safe considering factors such as frequency, mode of application and concentration. 

At this stage there do not appear to be clear guidelines on the use of sanitation tunnels at schools or other non-healthcare environments, and so we need to be extremely vigilant on what substances our children are exposed to. Substances need to meet regulatory requirements for safety and the substances need to be used for the purpose for which this safety has been shown. Prior to any regulatory clarity from the Department of Health and possibly also the Department of Trade and Industry, one should not be developing protocols to implement a sanitation tunnel at schools, or any other environment.