Principles for the Risk Analysis of Foods Derived from Modern Biotechnology 16 2549

1
??????????????????????????????????????????????????
????????????????Principles for the Risk
Analysis of Foods Derived from Modern
Biotechnology????? ???????????????????????????
???????? ???????16 ?????? 2549 ?????????? ?????
?.?????????????????????????????????????
????????????????????????????????????????????????
?????? ???????? 1
2
Principles for the Risk Analysis of Foods
Derived from Modern Biotechnology (2003)
Codex Ad Hoc Intergovernmental Task Force on
Foods Derived From Biotechnology
Thailand ACFS contact point
3
Principles for the Risk Analysis of Foods Derived
from Modern Biotechnology

• Section 1 Introduction
• Section 2 Scope and Definition
• Section 3 Principles

4
Section - 1- Introduction

• ??????????????????????????
• ???????????????????????????? (???????????)
• ??????????????????????????????????
  (????????????????)
• ??????????????????????????????????????????????????
  ???????? whole foods

5
Section - 1- Introduction (???)

• ??????????????????????????
• ??????????????????????????????????????????????????
  ???????????????????????????
• ?????????????????????????????????????
• (whole foods)

6
Section - 1- Introduction (???)
Principles for the Risk Analysis of Foods
Derived from Modern Biotechnology
Codex Working Principles forRisk Analysis
7
Section - 2 Scope and Definitions

• ?????????????????????
• ????????????????????????????????????????????
• ???????????????????????????????
• - ???????????
• ?????????????????? - ????????
• - ???????
• - ?????????????
• ?????????????????????????????????????????????????
  ???????????????????????????? ?????????????????????
  ????????????? ???????????????????????

8
Section - 2 (???)
????? Modern Biotechnology means the
application of ( i) In vitro nucleic acid
techniques, including rDNA and direct injection
of nucleic acid into cells or organelles, or
(ii) Fusion of cells beyond the taxonomic family,
that overcome natural physiological reproductive
or recombinant barriers and that are not
techniques reproductive or recombinant barriers
and that are not techniques used in traditional
breeding and selection.
9
Section - 2 (???) ?????
Conventional Counterpart means a related
organism / variety, its components and / or
products for which there is experience of
establishing safety based on common use as food
(It is recognized that for the foreseeable
future, foods derived from modern biotechnology
will not be used as conventional counterparts)
"??????????????"
10
Section 3 - Principles
??????????????????????????????????????????????????
????????? ?????????????? Codex Working Principles
for Risk Analysis (??? - ????. 9006-2548)
11
Risk Analysis
Risk Assessment
Risk Communication
Risk Management
12
Section 3 - Principles (???)
Risk Assessment ??????? ?????????
????????????????? ???? ????????????
??????????????????????????? ?????
??????????????????????????????
?????????????
13
Section 3 - Principles Risk Assessment (???)

• ????????????????????? (Safety assessment)
• ??????????????????????????????????????????
  ????????????????????? ??????????????????????????
  ??????????? ??? ??????????????
• ?????????????????????? ???????????????????????????
  ??????????????????????????????????????????????????
  ?????????????????????????????????

14
Section 3 - Principles Risk Assessment (???)

• ????????????????????? ???????????
• ?????????????????????????????????????????
• ??????????????????????????????????????
• ???????????????????????????????????????
  ??????????????????

15
Section 3 - Principles Risk Assessment (???)

• ?????????????? ?????????????????????????????????
  ?????????? ??????????????????????
  ????????????????????? ?? (case by case)
• ????????????????????????????????
• ???????????????????????
• ???????????????????????????
• ??????????????? ???????????
• ???????????????? scientific peer review

16
Section 3 - Principles Risk Assessment (???)

• ????????????????????????????????????????????????
  ????????????????????
• ???????????????????????
• ?????????????????????????????????????????????????
  ??? ????? ?????????????????
  ?????????????????????? ?????????????
  Guidelines-
• Guideline for the Conduct of Food safety
  Assessment of Foods Derived from Recombinant-DNA
  Plants
• Guideline for the Conduct of Food Safety
  Assessment of Foods Produced using
  Recombinant-DNA Microorganisms

17
Section 3 - Principles Risk Assessment (???)

• ????? ???????????????????????????????????????????
  ???
• ????????????????? ????????????????????
• ?????????????????????? ???????????????????
• ?????????????????????????????
  ???????????????????
• ?????????????????
• ?????????????????????????????????????
• ?????????????????????????????????????????????????

18
Section 3 - Principles Risk Assessment (???)

• ????????????????????????????????????????????????
  ????????????????????????????????? ??????????????
  ??????????????????????????? ???
  ???????????????????????????????????????

19
Risk Analysis
Risk Communication
Risk Assessment
Risk Management
20
Section 3 - Principles Risk Management
???????????????????????????
????????????????????????????
???????????????????????????
??? ???????? other legitimate factors(???
general decision ??? Codex Alimentarius
Commission ??? Codex Working Principles for
Risk Analysis )
21
Section 3 - Principles Risk Management

• ?????????????
• ???????????????????????????????????????
  ??????????????????????????????????????????????????
  ??????????????????????????????????????????????????
  ??????????????????????????????????????

22
Section 3 - Principles Risk Management (???)

• ???????????????????
• ???????????
• ?????????????????????????????????????????????????
  ???
• ????????????????????????????????????????????????
  ??????????

23
?????????????????????????? ?????????
Section 3 - Principles Risk Management (???)

• ????????????????
• ?????????????????????????????????????????????????
  ?
• ?????????????????????????????????
• ??????????????

24
Section 3 - Principles Risk Management(???)

• Post - market monitoring
• ??????????????????????????????????????????????
  ????????????????????????????
• ???????????????????? ??? ??????????? post -
  market monitoring ????????????????????????????????
  ?????????????????
• ??????????????????????????????????????????? ???
  post - market monitoring ?????????????????????????
  ?

25
Section 3 - Principles Risk Management (???)
Post - market monitoring

• ???????????????????????????????? ???????
  ?????????????????????
• ?????????????????????????????????????????????????
  ??????????????????????????????

26
Section 3 - Principles Risk Management (???)

• ????????? ??????????????????????????????????????
  ?????????????????????????????????????????????????
  ????? ?????????????
• ???????????????????????
• reference materials
• ??? tracing ????????? ???????????????????????????
  ????????????????????????????????????
  ????????????????????????????????????????
  ????????????????? post-market monitoring

27
Risk Analysis
Risk Communication
Risk Assessment
Risk Management
28
Section 3 - Principles Risk Communication

• ?????????????????????????????????????????????????
  ??
• ????????????????????????????????
  ??????????????????????
• ???????????????????? ???? interaction process
  ????????????????????????????????????????????
  ?????????? ?????????????? ????????????
  ????????????

29
Section 3 - Principles Risk Communication (???)

• ???????????????????? ???????????????????????????
  ?????????? ??????????????????????????????????????
  ?
• ?????????????????????????????????????????????????
  ???????? ??????????????? ?????????????????????????
  ??? ????????????????????????????????
  ?????????????
• ?????????????????????????????????????????????????
  ????????????????????????????????
  ???????????????????????????????

30
Section 3 - Principles Risk Communication (???)

• ???????????????????????????????????? ??????
  ???????????????????????
• ??????????????????????? interactive
• ??????????????????????????????????? ??????????
  ????????????????????????????????
  ??????????????????????????????
  ?????????????????????????????????????????????????
  ???????????????????

31
Section 3 - Principles Consistency

• ??? consistency approach ????????????????????????
  ????????????? ??????????????????????????????????
• ?????????????????????????????????????????????????
  ??? ???????????? ????????????????????????????????
  ???????????????????????????????????????????????
• ????????????????

32
Section 3 - Principles Consistency (???)

• ???????????????????????????????? ?????????
  ?????????????????????????????? ???????????????????
  ????????? ?????????????????????????????????????
• ????????????????? ?????????????????
  ??????????????????????????? ????????????????????
  ??????????? ??? ????????????? ???
  ?????????????????????????????????????

33
Section 3 - Principles Capacity Building and
Information Exchange

• ?????????????????????????????? ??????????????????
  ???????????????? ???????????????????????????
  ?????
• ???????????????? ????????????????????
• ???????????? ?????????????????????????????????????
  ????????????????
• ???????????????????????????? ?????????????????????
  ??????????????????? ??????????????????????????????
  ???????
• ??????? ??????????????????

34
Section 3 - Principles Capacity Building and
Information Exchange (???)

• ?????????????????????????????????????
• ??? bilateral arrangement
• ??????????????????????????????????????
• ???????????? ?????????????????????????????
  ???????? ???????????

35
Section 3 - Principles Capacity Building and
Information Exchange (???)

• ??????????????????????????????????
  ??????????????????????????????????????????????????
  ??? ?????????????????? ?????????????????????
  ??????????????????????????????????? ???????
  contact point ?????????? ?????????????????????????
  ??? Codex Contact Points ?????????????????????

36
Section 3 - Principles Review Process

• ????????????????????????????????????
  ????????????????????????????????????????
  ??????????????????????????????????????????????????
  ?
• ??????????????????????????????????????
  ??????????????????????????????????????????????????
  ??????????????????????????????????
• ?????????????????????????????????????????????
  ?????????????? ???????????????????????????????????
  ??????????

37
??????????????????????????????????????????????????
???????????? ?????????
?????? (?????????????)
Submitted document
Safety Assessment Report
???????????????????????????? Risk Manager
Submitted document
Safety Assessment Report
Food Biosafety Subcom. Risk Assessor
38
??????????