Safety Assessment of GM Foods - ANBio

beefzoologistΒιοτεχνολογία

21 Φεβ 2013 (πριν από 4 χρόνια και 8 μήνες)

136 εμφανίσεις


Food Biotechnology in Canada


Regulation and Safety Assessment Approach

Workshop on Food Safety Assessment of Foods derived from Recombinant
-
DNA Plants
(Rio de Janeiro, Brazil


Sept. 8
-
11, 2002)


Mireille Prud’homme

Acting Associate Director

Bureau of Food Policy Integration

Food Directorate,

Health Canada


2

Regulation of Biotechnology Products


Health Canada

-
Food and Drugs Act

-

foods, drugs, cosmetics, medical devices

-
Pest Control Products Act



pesticides



Canadian Food Inspection Agency (CFIA)

-
Seeds Act

-

plants

-
Feeds Act

-

animal feeds

-
Fertilizers Act

-

fertilizers

-
Health of Animals Act

-

veterinary biologics



Environment Canada

-
Canadian Environmental Protection Act



new substances

3

Regulation of Novel Foods

(including GM Foods)


Canadian
Food & Drugs Act



Novel Foods Regulation


Canada Gazette Part II, October 27, 1999


Notification prior to sale or advertising



Allows Health Canada to assess the safety and
nutritional quality of novel foods before they can be
sold or advertised for sale in Canada

4

What is a novel food?


A substance, including a microorganism, that does not
have a history of safe use as a food



A food that has been manufactured, prepared,
preserved or packaged by a process that:



has not been previously applied to that food, and


causes the food to undergo a major change



A food that is derived from a plant, animal or
microorganism that has been genetically modified

5

Why do we Regulate Novel Foods?

Pre
-
market notification in order to assess:




-
potential introduction of toxic compounds and allergens


-
changes in nutritional and compositional characteristics


-
potential for beneficial and adverse effects (short term
and long term)




6

Safety Assessment of GM Foods



Provides assurance that food will not cause harm to
the consumer when it is prepared and/or consumed
according to its intended use



N.B.:
Existing traditional foods are considered to be
safe through their long history of use even though they
may contain anti
-
nutritional factors or toxic substances
(e.g., trypsin inhibitors in soybean)

7

Safety Assessment of GM Foods




Health Canada Guidelines for the Safety Assessment
of Novel Foods (1994)







Step
-
wise, scientific evaluation





data and scientific protocols are critically examined



in
-
house expertise in molecular biology, toxicology,
chemistry, nutritional sciences and microbiology



intended and unintended changes considered


8

Safety Assessment of GM Foods


We examine how the food crop was developed,
including a full description of the genes involved and
their integration into the modified product;




Composition of the novel food compared to non
-
modified counterpart foods;



Nutritional information for the novel food compared to
non
-
modified counterparts;



Potential for production of new toxins; and



Potential for causing allergic reaction


9

Development and Production of the
Modified Organism

This part of the assessment considers:



Host and donor organisms



Introduced DNA and its expression



Modified organism and its metabolism

Data to characterize the modified organism and
permit comparison to the traditional counterpart

10

Dietary Exposure

This part of the assessment considers:



Details of the levels of the modified organism and/or its
metabolites in the finished food



Anticipated use pattern and dietary intake estimates for
the food in question

Level of exposure plays a key role in determining
the extent of data (nutritional and toxicological)
that may be required

11

Nutritional Assessment



Foods undergo nutritional assessments to determine
the potential for any nutritional changes (may require
animal studies).



Identification of micro and macro
-
nutrients relevant to
the food (e.g., vitamins, specific amino acids, lipids).



Any differences are evaluated for the risk to human
health when consumed as a food.

12

Toxicity Assessment

of Newly Expressed Proteins


The toxicity assessment focuses on the human safety of
introduced proteins and on the potential for unintended
changes in known toxins or anti
-
nutrients in the food



We consider:



Potential for the protein to be a toxin in humans



Enzymes could produce metabolites of unknown
toxicity

13

Toxicological Data


Traditional approaches to toxicological studies are
applicable to assessment of individual compounds or
simple mixtures.



Evaluation of whole foods using traditional approaches
provides technical difficulties. Work is underway to
develop appropriate methods.


14

Allergenicity Assessment

of Newly Expressed Proteins

Potential to be allergenic:



Is the source of the transferred genetic material
known to be allergenic?


Sequence homology to known allergens?


Stability to trypsin treatment


Heat and processing stability


Chemistry

Toxicology

Nutrition

Molecular biology

Microbiology

Additional Information

Required for Evaluation?

Pre
-
market

Notification

Assessment Completed by all

Evaluators

Food Rulings Proposal

Drafted

Food Directorate Senior

Management Review

Letter of No Objection sent

to Petitioner

Decision Document posted

on Health Canada Website

Post
-
Market

Information

Request for

Additional

Information

Manufacturer
of Novel Food


16

Safety Assessment
-

Key Concepts



Based upon scientific principles developed through expert
international consultations with WHO, FAO and OECD.



Comparative approach to existing foods with a history of
safe use in the diet.



Differences identified in the comparison are subjected to
further studies as appropriate.



Assessment considers impact of new trait or component
in the modified organism, and the final food.

17

GM foods



What have we assessed so far?



More than 50 GM foods approved to date




Most are derived from 10 common food crop species:


-

canola, corn, soybean, potato, tomato, etc.






First Generation of Modified Food Plants
-





Agronomic traits: improved pest resistance, herbicide


tolerance, etc.



Other traits: slow ripening and modified oil composition





18

Independent Expert Advice

on the Regulation of Food Biotechnology


Report of the Royal Society of Canada’s Expert Panel on
the Future of Food Biotechnology (February 2001)



Government action plan and first two progress reports available
on website. Next progress report to be published in December.



Report of the Canadian Biotechnology Advisory Committee
on the regulation of GM foods (August 2002)



Detailed government response anticipated to be published by the
end of this year.


19

HEALTH CANADA WEBSITE


-

Novel Food Decision Documents



-

Novel Foods Regulation and Guidelines for the Safety
Assessment of Novel Foods



-

Questions and Answers



-

Action plan in response to recommendations of the
Expert Panel on the Future of Food Biotechnology

http://www.hc
-
sc.gc.ca/english/protection/

biotech/index.htm