Current Regulatory Systems of GMOs in Korea

1
Current Regulatory Systems of GMOs in Korea
2001. 9. 6.

• Hyun-Suk Cho
• GMO Task Force
• Ministry of Agriculture and Forestry

2
Safety Regulatory System in Korea
Safety assessment system Labeling
system Communication with Consumer
3
Safety Assessment System
4
Safety Regulation of GMOs by Use
5
Environmental Risk Assessment of GM Agricultural
Products Derived from Biotechnology

• Guideline
• Voluntary Guidelines for Review of Agricultural
  Environment Risk Assessment Data Pertaining to GM
  Agricultural Products
• - MAF plan to enforce during the latter half
  of 2001
• Purpose
• To establish basic requirements on securing the
  safety of domestically and internationally
  developed GM agricultural products, so as to
  prevent potential risks on the domestic
  agricultural environment in advance

6
Points to Consider in Environmental Risk
Assessment

• Existence and expression of introduced gene
• Reproductive characteristics
• The production of toxic substance
• The possibility of transfer of the introduced
  gene
• The impacts on agricultural environment
• Weediness

7
The convind field trial to test the possibility
of transfer the induced gene into the rice
8
Safety Assessment System of GM Foods Derived from
Biotechnology

• Guideline of safety assessment for GM foods and
  GM food
• additives (KFDA Notification no. 1999-46,
  enforced on
• 8/20/1999)
• Purpose
• To ensure safety of foods and food additives
  derived from
• biotechnology
• Approved items 1 crop (Soybean GTS40-3-2,
  Monsanto)
• Pending items 4 crops

9
Safety Assessment System of GM Feeds Derived
from Biotechnology

• Voluntary Guidelines for Review of Safety
  Assessment Data Pertaining to GM Feeds (To be
  developed)
• Purpose
• To consider safety and efficacy of feeds from
  plants with novel traits prior to feeding to
  livestock.

10
Labeling system
11
Labeling system

• Raw materials (crops)
• MAF-enforced on 3/1/2001
• Notification no. 2000-31
• soybean, corn, soy-sprout (threshold 3) and
  potato(from 1st March, 2002)
• Methods To be GM or may be contain GM
• Processed foods
• KFDA- to be enforced on 7/13/2001
• Notification no. 2000-43
• 27 processed foods made from soy, corn and
  soy-sprout
• Methods GM soy, GM corn or may be contain GM

12
Labeling Regulation of GM crops Derived from
Biotechnology

• Law
• Agricultural and Fishery Product Quality Control
  Act (Jan. 21. 1999)
• Guidelines for Labeling of Genetically Modified
  Agricultural Products (April. 22. 2000)
• Purpose
• To provide consumers correct information on GM
  crops
• To ensure Right-to-Know and Right-to-Choose

13
Labeling Standard of GM crops

• As for GM agricultural products
• Genetically Modified Soybean (Corn)
• As for agricultural products containing GMO
• Containing Genetically Modified Soybean (Corn)
• As for agricultural products containing possible
  GMO
• May contain Genetically Modified Soybean (Corn)

14
An Example of labeling of GM soy-sprout
GM soy-sprout
15
Labeling Methods of GM crops

• Without Package Be marked at the sales point
• by way of a
  notice board, a post , and etc
• With Package Be directly labeled on package
• Font shall be in a size that purchasers can
  recognize easily.

16
Labeling Regulation of GM Foods Derived from
Biotechnology

• Law
• Food Sanitation Act (Jan. 13. 2000)
• Labeling Standard for Genetically Modified foods
  (August. 30. 2000)
• Purpose
• To provide correct information to consumers about
  GM food
• - Truthful
• - Not Misleading information
• - To ensure consumers Right-to-Know and
  Right-to-Choose

17
Basic Principles for GM Food Labeling

• Any one or more of top 5 major raw ingredients
  subject to
• GM labeling
• Soybeans or Corns containing GM exceeding 3
  level
• Shall contain any residual recombinant DNA or
  foreign proteins
• in the final products after manufacturing or
  processing

18
Control of GMO Labeling
Confirmation by scientific analysis preparation
by official analytical methods Qualitative
analysis (PCR, rapid test kit) Quantitative
analysis (realtime PCR, ELISA) designation of
official analysis laboratory Confirmation by
certifying an identified preservation guideline
for IP handling standardization of certification
19
Transgenic rice developed in Korea (containing
herbicide resistance gene)
20
Transgenic chinese cabbage containing
insecticidal gene (BT gene)
21
Cummunication with consumer
22
Most valuable benefits of GMO
Don't know 6
Healthier 17
23
Labeling of GMO
24
Willingness to buy GM products
25
Acceptance of vitamin-rich GM soybean
26
Acceptance of herbicide-resistance GM soybean
27
Ensure Safety and Transparent Policies of GMO by
Mutual Understanding and Cooperation
28
Conclusions

• Safety assessment system in Korea
• Environmental safety MAF preparing for
  voluntary guideline
• Food safety KFDA, mandatory guideline(July,
  2001)
• Labeling system in Korea
• GM crops MAF(March 1. 2001)
• GM foods KFDA(July 13. 2001)
• Communication with consumer
• The survey result of consumer attitude of GMO
  in Korea was many people expressed vague anxiety
  about GMO. Exact public information and clear
  policy were needed.

29
Summary of the guidelines for agricultural
environment risk assessment (continued)

• Document Disclosure
• - The information on GM agricultural products
  will be notified to public for 30 days to collect
  opinions
• Specialist Evaluation Committee
• - A Chairman (selected within the committee)
  and a vice-chairman from academia and from its
  related professional pool plus less than 15
  members The term of membership limitted to the
  review completion
• Notification and Monitoring after Approval
• - MAF notifies the result to applicants
• - Conduct monitoring after the approval
• Re-application
• - Re-application possible within 60 days of
  refusal
• - Its result is notified within 90 days after
  re-application

30
Summary of the guidelines for agricultural
environment risk assessment

• Require document Application, risk analysis
  paper (safety assessment data of GM plants or GM
  microorganisms)
• Review analysis
• - Reviewed by within 270 days
• - If required, additional document and on-site
  inspection necessary
• - Operation of ltSpecialist Evaluation
  Committeegt for professional assessment
• Important facts on application
• - Two applications and 20 copies of
  environment risk analysis paper
• - In foreign document (original and translated
  summary included)
• - In case for confidential business
  information(CBI) contained, submit 20 copies (15
  copies without CBI and 5 copies with CBI)

31
Point to Consider on GM Feeds

• Safety assessment of inserted gene
• Risk assessment for toxic components
• Transferability of inserted DNA and protein to
  animal tissue
• Feed intake analysis
• Compositional analysis of key components etc.

32
Transgenic rice containing herbicide resistance
gene on the pot
33
Environmental Risk Assessment of transgenic
potatoes to produce toxic substances
34
Application Procedure (Environmental Risk
Assessment)
Approval
Apply
If required, supplementary materials necessary
35
Safety Assessment System of Foods Derived from
Biotechnology (continued)

• Committee on Safety assessment of foods derived
  from
• biotechnology
• (composed by 15 experts with major in
  molecular biology, food
• technology, toxicology, medical science,
  microbiology,
• nutrition etc)
• Approved items 1 crop, 1 additive
• (soybean GTS 40-3-2, Monsanto company)
• Pending items 4 crops

36
Points to Consider on Foods Derived from
Biotechnology

• Inserted gene, methods of insertion, products
  etc.
• Toxicity no individual variation
• Allegenicity individual variation
• Resistance of antibiotics
• Transfer of gene

37
Labeling Methods of GM Food

• At the Principle Display Panel
• Recombinant DNA or Food(s) containing
  Recombinant
• Soybean(Corn)
• At the list of raw ingredients
• Recombinant DNA or Recombinant soybean(Corn)
• Example Soybean (recombinant DNA)
• Can not confirm GM ingredients
• May be containing recombinant DNA

38
Detection method developed in Korea
39
Transgenic plants and animals developed in Korea

• 14 crops 35 species (developed in laboratory or
  field trial)
• Field trial rice, wheat, cabbage, chinese
  cabbage, potato
• Laboratory tomato, lettuce, pepper, sesame,
• the chrysanthemum, garlic,
  water melon, apple etc.
• 2 animals 5 species pig and chicken
• Any GMO developed in Korea was not
  commercialized