New substances: notification and assessment 16936

Topic

The notified micro-organism is a naturally occurring bacteriophage that is part of the "Finalyse™ EC" product which will be imported into Canada by Elanco Canada. It was isolated from recycled waste water from a beef processing plant in Arkansas USA. Bacteriophages are viruses that infect bacteria by recognizing and binding to specific receptors on the cell wall, injecting their DNA into the cell and inducing the replication of viral particles and subsequent cell lysis (rupture of the cell).
The genus and species name of the notified bacteriophage is not provided as it has been claimed to be confidential by the proponent and this masked name has been accepted by the Government.

Finalyse™ EC will be used as a processing aid in order to help reduce pathogenic Escherichia coli (E. coli) on cattle hides after the animals are killed.

A micro-organism that is not on the Domestic Substances List (DSL) and is not subject to federal legislation listed in Schedule 4 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), is considered “new” and before it is manufactured in or imported into Canada, the Government must assess its potential to harm human health and the environment under the New Substances Notifications Regulations (Organisms), as required by Section 106 of CEPA 1999. The bacteriophage found in Finalyse™ EC is not on the DSL.
The Government of Canada conducted an assessment on Finalyse™ EC because Elanco Canada submitted a notification of its intention to import this product containing a new micro-organism into Canada for use in reduction of pathogenic E. coli from cattle hides.

For the notified use, Finalyse™ EC can be released to the environment via the waste water treatment process of beef production facilities. As such, bacteriophages end up in run-off liquids from sprayed animals which will enter the wastewater stream.
Because of its ability to interfere with the growth and survival of pathogenic E. coli, other potential use scenarios of Finalyse™ ECinclude use in wastewater treatment, food additives, disinfectants or pharmaceutical products intended for homes as well as public institutions. These alternate uses could result in release of the product directly to the general environment, including water bodies.

Based on the intended use, the general population in Canada is not expected to be exposed to Finalyse™ EC. Given alternate uses, people could likely be exposed to the bacteriophage and the direct human exposure from the potential uses of the notified organism could be high.
The notified micro-organism is known to have a limited host range; and in the absence of a viable host, phages are generally susceptible to environmental conditions such as ultraviolet light, extreme temperatures, and desiccation, and are not expected to persist. Even if it succeeds to enter a person, adverse effects are unlikely, since test data have shown that predominant human commensal gut bacteria are not susceptible to the notified bacteriophage.

The Government of Canada has conducted a science-based risk assessment of the notified bacteriophage found in the Finalyse™ EC product.
Risk assessments address potential for harm to the general population in Canada (not including workplace exposures) and the environment.
The notified bacteriophage has not been found to cause adverse effects in humans, animals or plants. This type of bacteriophage has decades-long history of safe use as antimicrobial therapy in humans and in standard toxicity tests with animal models.
Finalyse™ EC is therefore not considered to be harmful to human health or the environment for both intended and potential future uses; and the Government of Canada has concluded that Finalyse™ EC is not entering the environment in a quantity or under conditions that constitute a danger to the environment or humans.

Based on the conclusion of the risk assessment, the Government of Canada will take no further action on Finalyse™ EC.

2021-02-10