Flowchart ("Roadmap") for risk assessment: the necessary steps to conduct risk assessment according to Annex III of the Protocol

General Comment

In some cases, LMOs might be released into the environment so that they persist there, for example, when LMO technology is applied to rescue perishing endangered species. Annex III should recognize potential of such applications.

Specific comments

1. It is important to incorporate or recapitulate　the general principle paragraph 5, i.e, “Risks associated with living modified organisms or products thereof, namely, processed materials that are of living modified organism origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology, should be considered in the context of the risks posed by the non-modified recipients or parental organisms in the likely potential receiving environment.”  in sections of methodology (paragraph 8) and Points to consider (paragraph 9).

2. Under Methodology, it is important to identify “the non-modified recipients or parental organisms” and “the environment where the non-modified recipients or parental organisms normally exist”, which may be called “conventional counterpart(s)” and “original/conventional environment”, respectively. With such comparators, points described in paragraphs 8 and 9 can be properly assessed. 

3. It is important to note that all the considerations from (a) to (f) apply to the conventional counterparts, i.e., the non-modified recipients or parental organisms.

For Methodology

1) The first step could be to ask whether the non-modified recipients or parental organisms are alien to the receiving environment.

2) If they are, they can be examined by using conventional law, such as quarantine law, and then for their possible familiarity to the potential receiving environment. Familiarity can be assessed by asking whether we have sufficient knowledge to manage them once they are introduced into the environment

3) Then, new or altered hazard (the definition of hazard used here is “a biological agent with the potential to cause an adverse effect”, codex definition) of the LMO in question should be identified through safety assessment using the non-modified recipients or parental organisms as comparators. 

4) The assessment process (a – f) and results, including the scientific data and information used for assessment, should be recorded. 

5) Monitoring

The term “monitoring” in (f), needs further consideration. The interaction of LMOs with other organisms and environment is complex, and just monitoring the survival of LMOs in the environment is often meaningless. Therefore, when monitoring is considered, “its need and utility should be considered, on a case-by-case basis, during risk assessment and its practicability should be considered during the risk management. The monitoring may be undertaken for the purpose of:

a) verifying conclusions about the absence or possible occurrence, impact and significance of potential environmental effects,; and

b) monitoring changes in environmental parameters (that are identified through the risk assessment) to determine their environmental impact. “

Note

1. The sentence in the quotation mark is modified (underlined part) from paragraph 20 of Principles for the Risk Analysis of Foods Derived from Modern Biotechnology.  

2. The monitoring of GM food and LMO may appear entirely different in nature. However, the principle could be similar. Differently from chemicals used for food additives, safety of whole food, such as GM potatoes, rice, etc, is very difficult to evaluate on account of interaction with other foods, physiological condition of consumers, cooking, storage, consumption pattern, etc. Under these circumstances, comparative safety assessment approach is adopted (paragraphs 9-13 of Guideline for rNDA foods).

3. Monitoring GM food is not easy to practice and is very costly. Therefore, it was recognized that, if monitoring is to be performed, it is important to have a hypothesis to prove. The situation could be the same for LMOs released into the environment. Without knowing what to prove, we do not know what events to be followed.

In some case, monitoring survival of LMOs per se may not be important, but its adverse or beneficial effects should be monitored. In this respect, “biomarkers or other parameters for monitoring the environmental effects of LMOs should be identified if there are any. “