Regulatory Procedure for the Assessment of GM Foods

Traditional Views of Food Safety

Historically, our beliefs about the safety of foods have been based almost entirely on tradition and cultural experience In practice, very few of the foods we eat today have been subject to any toxicological studies and yet they are genetically accepted as safeEven foods that contain toxins or anti-nutrients have been considered safe through a long history of use

What’s Changed?

Genetically modified (GM) foods Scrutinized by scientists, regulators and the public

Subject to unprecedented regulatory oversight

Have caused us to rethink our traditional views of food safety

Definition of “safe”

Approaches to systematically evaluating safety

FOOD SAFETY

FOOD SAFETY, involves all those hazards, whether chronic or acute, that

may make the food injurious to the health of consumers.

IT IS NOT NEGOTIABLE

(FAO 2003)

Can Safety be Proven?

It is impossible to prove that something is safe “Zero” risk and “Absolute” safety are impossible to achieve in the food system

GM Foods- Safety Review

Takes around 10-14 years: Laboratory research Contained greenhouse evaluation Contained small scale field trials Pre-commercial testing Commercial release

Key Initiatives

Codex Ad Hoc Intergovernmental Task Force on Foods Derived from Biotechnology

General Principles for the Risk Analysis of Foods Derived from Recombinant DNA Plants

Guidelines for the Conduct of Safety Assessment of Foods Derived from Recombinant DNA plants and Microorganisms

The Comparative Approach

Based on the principle that you can compare a GM food with a counterpart having a history of safe use

Comparison can include an evaluation of the same risk factors established for the counterpart

This approach is commonly referred to as the “Substantial Equivalence” approach

Goals of Substantial Equivalence

To structure the safety assessment relative to the counterpart food

To identify intended or unintended differences on which further safety assessment should focus

To determine “…as safe as…”

Substantial Equivalence

is not... A safety assessment in itself

A characterization of the hazard

An endpoint in the risk assessment process

Limitations of Substantial Equivalence

Availability of a counterpart

Availability of data on agronomic / compositional properties

Availability of data on natural variations

Availability of analytical methods

Codex Guidelines for Foods Derived from Recombinant DNA Microorganisms

The Safety assessment of a food produced using a recombinant DNA microorganism follows a stepwise process of addressing relevant factors, including: Description of the rDNA microorganism

Description of recipient microorganism and its use in food production

Description of donor organism

Description of the genetic modification(s) including vector and construct

Characterisation of the genetic modification(s)

Codex Guidelines for Foods Derived from Recombinant DNA Microorganisms

Safety assessment:

-Expressed substances: assessment of potential toxicity and other traits related to pathogenicity;

-Compositional analyses of key components;

-Evaluation of metabolites;

-Effects of food processing;

-Assessment of immunological effects; allergenicity

-Assessment of viability and residence of microorganisms in the human GI tract

-Anitibiotic resistance and gene transfer

-Nutritional modification

International Consensus

Even considering its limitations, the concept of substantial equivalence as a tool to help regulators structure the safety assessment process has been reaffirmed on numerous occasions internationally There are no alternative strategies that provide a better assurance of safety (WHO/FAO Joint Expert Consultation, 2000)

‘some form of substantial equivalence, starting with a direct comparison of the novel foodstuffs with their unmodified counterparts, appears to be the only practical solution’

The goal of each safety assessment is to

provide assurance, in the light of the best

available scientific knowledge that the food does

not cause harm when prepares, used and/or eaten

according to its intended use.

Questions that need to be answeredIs the transferred DNA safe to consume?

If an antibiotic resistance marker is used, is it safe?

Are the newly produced proteins safe to consume?

Have potential allergens been introduced into the food?

Are the composition and nutritional value changed?

Questions that need to be answered

Are there changes in the content of important substances?

In what forms will the food or food products isolated from it be consumed?

Do the newly introduced substances survive processing, shipment, storage and preparation?

What is the expected human dietary exposure?

BAFPS Framework on Food Safety Assessment of GM Foods

Sound scientific evidence Pursued in accordance with recognized risk

assessment guidelines and appropriate sampling techniques

Carried out in a transparent manner Evaluation shall consider the safety of its

conventional counterparts Shall take into account the history of safe use as

food source from the importing country

BAFPS Assessment of GM Foods

Focused on Horizontal Gene transfer Safe use of Antibiotic Resistance Marker Gene Nutritional Composition Possible allergenicity Unintended effects

General Approach to Biosafety

Agriculture Health

Environment

Guidelines

Summary

Important components of GM regulation

Guidelines – risk assessment, management

Legislation – GM process, GM products

Periodic re-evaluation of Guidelines and implementation procedures give the applicants, reviewers, administrators, regulators and the public an opportunity to assess how well the system is working

THANK YOU!