Participate in the risk assessment process for the EntoEngine fly producing human FGF2

From: Environment and Climate Change Canada

Current status: Closed    

The New Substances program is seeking scientific information and test data that could inform the risk assessment process for the EntoEngine fly producing human FGF2. From September 1 to October 1, 2023, Canadians are invited to submit scientific information and test data as part of the Voluntary Public Engagement Initiative.

Background

The New Substances program, jointly administered by Environment and Climate Change Canada and Health Canada, is currently evaluating the EntoEngine fly producing human FGF2, notified by Future Fields on July 5, 2023.

This genetically modified Drosophila melanogaster, commonly referred to as the “fruit fly”, acts as a living insect bioreactor. It is capable of expressing recombinant proteins on demand. The line subject to this notification expresses a growth factor protein (human FGF2). Growth factors are the unique cell signaling molecules that play important roles in cell proliferation and development. The present growth factor (human FGF2) is intended for use as a highly purified component of cell culture medium for research use only.

Drosophila melanogaster have been used in research settings globally since 1909.There is no evidence to date of adverse environmental impact. Drosophila are not the intermediate host for any parasite, and are not naturally infected by any pathogen of human or agricultural concern.

The EntoEngine fly line has been genetically engineered to express the growth factor protein - human FGF2. The gene sequence of interest is not known to be toxic to either humans or animals.

Expression of the gene encoding the growth factor is under the control of a promoter activated by a specific stimuli. This means the growth factor protein is not constitutively expressed in the host organism and does not produce the recombinant protein under typical rearing or environmental conditions.

Future Fields applies preventative controls, including containment measures for all genetically engineered organisms. They are kept triple contained in shatter-proof containers within a designated production area (interior room) that has physical barriers and controlled personnel entry and exit.

Measures are taken to ensure safe and regulated disposal of all surplus organisms and associated waste via a contracted hazardous waste management company. Live organisms do not leave the Future Fields facility and are fully processed on site. The commercial end product is a highly purified recombinant human FGF2 protein. Downstream processes ensure the removal of host components including but not limited to DNA, RNA, proteins and lipids.

Correction: The summary initially stated that Future Fields’ genetically engineered flies have a curly wing phenotype that causes flightlessness, resulting in minimal likelihood of escape or dispersal. However, the probability of transmission of the inserted trait for this strain of Drosophila melanogaster is 66.67%, meaning approximately ⅓ of the adult fly population would be expected to develop straight wings. Any adult fly with straight wings will be discarded before breeding.

Join in: how to participate

We invite all interested to share scientific information and test data related to potential risks to the environment or human health from the EntoEngine fly producing human FGF2.

By mail

Send your comments to the address in the Contact us section below.

By email

Submit your comments by email: substances@ec.gc.ca

Review our privacy statement for this consultation.

Who is the focus of this consultation

We would like to hear from:

Key questions for discussion

We invite Canadians to provide scientific information and test data that could inform the risk assessment process.

Related information

Contact us

Substances Management Information Line

Science and Technology Branch
Environment and Climate Change Canada
Place Vincent Massey, 351 St. Joseph Blvd
Gatineau QC  K1A 0H3

Telephone: 1-800-567-1999 (Toll Free in Canada) or 1-819-938-3232 (Outside of Canada)

E-mailsubstances@ec.gc.ca

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