Questions and Answers - Plant Molecular Farming

Q. What is plant molecular farming?

Researchers define plant molecular farming in a number of ways. Consistent with Canadian definitions for plants with novel traits (PNTs), the Canadian Food Inspection Agency (CFIA) has adopted a working definition as follows:

"The use of plants in agriculture to produce biomolecules instead of food, feed and fibre. Plants with introduced novel traits that produce scientifically, medically or industrially interesting biomolecules are grown as crops and harvested for the biomolecules".

Q. What other ways might be these products be produced?

Prior to the development of recombinant DNA technology in the 1970s, protein drugs were available in extremely limited supplies; for example, human cadavers were the source for human growth hormone, and insulin to treat diabetes was collected from slaughtered pigs.

Many pharmaceutical proteins and industrial enzymes have been produced by genetically engineered bacteria since the 1970s.

Q. Will all vaccines and therapeutic proteins eventually be produced by plant molecular farming?

No. While many therapeutics may be "manufactured" in plant molecular farming systems that ensure cost-effective production of safe and functional products, others do not lend themselves well to such a production system. In some cases, the molecules cannot be synthesized properly in plant tissues. In other cases, while costs of production by plant molecular farming are generally lower than other production systems, the costs of recovery of functional products may be too high. In still other cases, the risks to human, animal and environmental health may be considered unacceptable.

Q. Is there plant molecular farming going on now in Canada?

There is no commercial plant molecular farming in Canada to date, and none is anticipated in the near future. However, a number of organizations have been conducting research on PNTs for molecular farming in laboratories and greenhouses as well as in a limited number of approved confined field research trials. The CFIA anticipates that developers will seek approval for commercial production of PNTs for molecular farming in three to five years.

Q. Are plants used for molecular farming safe for the environment?

PNTs for molecular farming raise additional concerns compared to PNTs for food, feed or fibre because their products may affect the physiology of humans, animals, or any wildlife that may accidentally ingest them.

CFIA evaluators carefully and thoroughly assess the potential impacts of all plants with novel traits including those used for molecular farming, before these products are approved for either confined research field trials or for unconfined environmental release. This assessment considers potential impacts of the PNT on wildlife and other non-target organisms.

PNTs may be considered unsafe for the environment if the novel trait makes the plant more likely to persist as a weed in non-agricultural habitats. When the novel trait is production of molecular farming product, no increase in weediness is expected.

PNTs may also be considered unsafe for the environment if the novel trait can be transferred to other plants of the same or related species. A number of mechanisms such as male sterility can be used to mitigate against gene flow through cross-pollination

Confined field trials of PNTs in Canada, including those for molecular farming, are of restricted size and number and are carried out under strict terms and conditions that mitigate against escape of the PNT or its pollen. See also Regulatory Directive 2000-07 Guidelines for the Environmental Release of Plants with Novel Traits Within Confined Field Trials in Canada.

There are no plants for molecular farming approved for pre-commercial or unconfined release into the environment.

Q. Are there human health impacts of plants used for molecular farming?

Some plants used for molecular farming may produce compounds (such as pharmaceuticals) that affect human health. Human health impacts of accidental ingestion, or contact by workers or bystanders, may be unknown. Some field tests of such plants have been carried out in Canada under confined conditions that ensure that the plant material does not enter human food or animal feed supplies. Occupational and bystander safety and exposure are taken into consideration in the authorization of these field trials.

There are no plants for molecular farming currently in commercial production or authorized for unconfined release into the environment in Canada. At the request of stakeholders, the CFIA is developing guidelines for pre-commercial release of plants for molecular farming that will provide for strict measures to ensure the plant material does not enter human food or animal feed supplies, and that plant material with potential negative health impacts for workers or bystanders is not released into the environment.

Q. How is the CFIA regulating plants for molecular farming?

CFIA's Plant Biosafety Office (PBO) is responsible for assessing PNTs, including those used for molecular farming. All PNT products undergo a stepwise assessment process before unconfined release into the environment is permitted.

Before any PNT can be considered for commercial production in Canada it must undergo confined field testing to gather information about the potential impacts on the Canadian environment and biodiversity. (See Regulatory Directive 2000-07 Guidelines for the Environmental Release of Plants with Novel Traits Within Confined Field Trials in Canada.) In granting approval for confined field trials, CFIA evaluators carefully consider potential impacts of the PNT on wildlife and other non-target organisms. To mitigate against potential negative environmental effects, terms and conditions are imposed by the CFIA on confined field trials including:

1. Reproductive isolation of the PNT from all other similar crops

2. Plants and plant material from the trial site must not be allowed to escape to other environments

3. No material from the trial site may enter the human or animal food chain

4. The trial site must be open for Agency inspectors at any time

5. Following the trial, the site must not be planted with the same or a related species for a prescribed period, depending on the biology of the crop tested (e.g. following a canola trial, canola or related species may not be planted on the trial site for three years after the completion of the field trial)

6. Trials can be no more than a hectare in size, and no more than five trials of any PNT may be carried out in any one province in a given year.

Commercial production for PNTs for food, feed or fibre is subject to approval for unconfined environmental release that considers data on environmental impacts gathered from confined field trials. (See Regulatory Directive 1994-08 Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits).

Because of the additional environmental and human and livestock health concerns, PNTs for molecular farming may not be eligible for unconfined environmental release. Instead, commercial production of PNTs for molecular farming may be subject to additional rules, terms and conditions prescribed by new guidelines currently being developed by the CFIA.

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