Cablegate: Draft Biotech Regulations Could Hamper Trade
RR RUEHAG RUEHAP RUEHCHI RUEHCN RUEHDE RUEHDF RUEHDT RUEHGI RUEHHM
RUEHLZ RUEHMA RUEHMR RUEHPA RUEHPB RUEHRN
DE RUEHHI #0064/01 0170946
ZNR UUUUU ZZH
R 170946Z JAN 08
FM AMEMBASSY HANOI
TO RUEHC/SECSTATE WASHDC 7020
INFO RUEHHM/AMCONSUL HO CHI MINH 4161
RUEHGV/USMISSION GENEVA 1225
RUEHZS/ASEAN REGIONAL FORUM COLLECTIVE
RUCNWTO/WORLD TRADE ORGANIZATION COLLECTIVE
RUEATRS/DEPT OF TREASURY WASHINGTON DC
RUEHRC/DEPT OF AGRICULTURE WASHINGTON DC
RUCPDOC/DEPT OF COMMERCE WASHINGTON DC
RUEAIIA/CIA WASHINGTON DC
RHEHNSC/NATIONAL SECURITY COUNCIL WASHINGTON DC
UNCLAS SECTION 01 OF 04 HANOI 000064
STATE PASS TO USTR (CROWDER, BISBEE, CLARKSON)
USDA FOR DUS TERPSTRA
USDA PASS TO FAS (OA, OSTA, ONA, OCRA, OFSO)
TREASURY FOR OASIA
E.O. 12958: N/A
TAGS: EAGR ETRD WTRO TBIO USTR VM
SUBJECT: Draft Biotech Regulations Could Hamper Trade
HANOI 00000064 001.2 OF 004
1. Summary. This cable provides translation of Vietnam Food
Administration's latest draft biotechnology regulations, which are
expected to be formally notified to the WTO soon. On their face,
the regulations could hamper or restrict U.S. exports of biotech
products. Post would welcome comments from Washington to share with
Vietnamese officials. End Summary.
2. Vietnam Food Administration, (VFA) the regulatory agency under
the Ministry of Health that oversees food safety, recently shared
with FAS/Vietnam the tenth draft of its regulations governing the
import and trade of biotech foods. FAS/Vietnam has had the draft
regulations translated into English (see full text in para 5).
Although VFA has not specifically solicited comments, Post
encourages comments from FAS and other relevant USG agencies because
we believe they would be of interest to VFA. Post understands that
Vietnam will formally notify these draft regulations to the WTO
within a week.
3. It appears to Post that these draft regulations were written
from a standpoint of an underlying distrust of biotech foods; hence
the provisions for seemingly excessive surveillance and safeguards.
Importers and traders are being subjected to undue and unreasonable
requests for possible proprietary information as well as special
licenses in order to conduct trade.
4. These draft regulations appear to apply to bulk commodities as
well as processed foods, two areas where U.S. export trade has
experienced considerable growth over the last year. Approval and
implementation of these regulations could have a deleterious effect
on our trade. Particularly troubling are the demands for
confirmation outlined in Chapter III as well as the trade and
labeling requirements of Chapter IV. It would appear from item 2 of
Article 9 that a special license is required to engage in trade of
5. BEGIN TEXT
REGULATIONS ON MANAGEMENT OF SAFETY AND HYGIENE OF FOOD ORIGINATED
FROM GENE-MODIFIED ORGANISM
(Issued in conjunction with Decision /2007/QD-BYT dated 2007
of the Minister of Health)
CHAPTER I: GENERAL PROVISIONS
ARTICLE 1: SCOPE OF APPLICATION
1) These Regulations stipulate the management of safety and hygiene
of food originated from gene-modified organisms produced in the
country or imported to be circulated and sold in Vietnam, including
the following products (collectively called gene-modified food).
a) Materials being gene-modified food which has been industrially
processed without re-refining in order to be used for direct
productions, packed or re-packed;
b) Packed food for direct use, which contains gene-modified
2) The following gene-modified food shall not be regulated by these
a) Fresh or primarily treated gene-modified food falling within the
list subject to plant and animal quarantine;
b) Gene-modified food being test or research samples;
c) Gene-modified food being sample in fairs;
d) Gene-modified food being agriculture products imported and
ARTICLE 2: SUBJECTS OF APPLICATION
These regulations shall be applicable to organizations and
individuals who produce, trade and import gene-modified food as
stipulated in Clause 1, Article 1 of these regulations.
ARTICLE 3: EXPLANATION OF WORDS AND EXPRESSION
In these regulations, some words and expression shall be construed
1) Gene-modified food is the food originated from gene-modified
organisms or the ingredients of the food which are originated from
2) Gene modified materials shall be the materials obtained from
gene-modified organisms, which are used for production of products
and which exist in the finished products even the form of the
materials is already changed.
HANOI 00000064 002.2 OF 004
3) Labeling gene-modified food is to express the basic and necessary
contents of the gene-modified food on the label of products so that
consumers can identify, use them as basis to select and use; so that
producers and traders advertise their products and so that the
functional agencies conduct examination, inspection and
4) Biological safety requirements with respect to gene-modified food
mean ensuring that gene-modified materials used for production of
gene-modified food must be subject to risk assessments in order to
minimize or reject gene-modified materials, which cause danger of
toxicity or allergy to people's health; danger of adverse impacts on
the environment and biological diversification.
5) Hygiene and safety requirements with respect to gene-modified
food means ensuring that gene-modified food is produced at
establishments satisfying the hygiene and safety requirements in
accordance with the regulations and not affecting to nor harming
6) Danger of affecting to people's health of gene-modified food is
the possibility of causing allergy and toxicity or special
constituents being toxicity or instability of transplanted gene or
efficiency of increasing the nutrition content or any effect occurs
due to transplanting new gene.
ARTICLE 4: GENERAL REQUIREMENTS
1) Gene-modified food products circulated or sold in the market must
satisfy the following requirements:
a) Safety for people's health;
b) Being labeled in accordance with Article 11 of these
c) Complying the periodical inspection in accordance with the
2) Name of establishments producing and trading gene-modified food
a) Have certificate on satisfaction of hygiene and safety
requirements with respect to other food of high danger.
b) Archiving goods' dossiers and other report documents relating to
gene-modified food for 5 years and being ready to provide them at
the request of the competent State body.
CHAPTER II: REGULATIONS APPLICABLE TO GENE-MODIFIED FOODS
WHICH ARE LOCALLY PRODUCED
ARTICLE 5: HYGIENE SAFETY REQUIREMENTS OF LOCALLY-PRODUCED
GENE-MODIFIED FOOD PRODUCTS
Before circulated and sold in the market, locally produced
gene-modified food must satisfy the following requirements:
1) Having assessed the danger.
2) Having certificate on safety of ingredients of gene-modified food
issued by the Ministry of Agriculture and Rural Development.
ARTICLE 6: ANNOUNCEMENT OF THE STANDARDS OF LOCALLY PRODUCED
Apart from implementation of regulations on announcement of the
products' standards on gene-modified food in accordance with the
current regulations, organization and individuals who produce and
trade gene-modified food must provide the following information:
1) Name of gene-modified food products;
2) Name of transplanted gene: purpose, position, characteristics,
stability of transplanted gene;
3) Having certificate on safety:
b) Not creating toxicity affecting to the people's health;
c) Nutrition composition and substances;
d) Stability of transplanted gene.
CHAPTER III: REGULATIONS APPLICABLE TO IMPORTED GENE-MODIFIED FOOD
ARTICLE 7: HYGIENE SAFETY REQUIREMENTS OF IMPORTED GENE-MODIFIED
Gene-modified food imported into Vietnam to circulate or be sold in
the market must satisfy the following requirements:
1) Exporting country permits it to circulate nationwide;
2) The danger (of the food) has been assessed;
3) Having a Certificate on safety and test report with norms as
issued by the competent body of exporting country;
4) Exporting country has established measures and regime for
management of these products.
HANOI 00000064 003.2 OF 004
ARTICLE 8: PROCEDURE FOR IMPORT
1) Imported gene-modified foods shall have to comply with the law on
imported food and shall have to announce the products' standards at
the Ministry of Health (Department of Food Safety and Hygiene).
Besides, the exporting party shall have to provide the following
a) Confirmation of non-danger of allergy (the transplanted gene has
the safe origin)
b) Confirmation of no danger of creating toxicity;
c) Confirming that there is no anti-biotic resistance;
d) Report on confirmation of nutrition composition as compared with
e) Confirmation of stability of transplanted gene (until the sixth
f) Ratio of GM-protein or GM-AND being modified in the food;
g) Name of transplanted gene: purpose, position, characteristics and
stability of replacing gene.
2) In case where exporting country and Vietnam have signed an
agreement on recognition of gene-modified food, (the procedure for
import) shall be implemented in accordance with this agreement.
CHAPTER IV: TRADING, ADVERTISEMENT, LABELING, SUPERVISION AND
SUSPENSION OF CIRCULATION OF GENE-MODIFIED FOOD
ARTICLE 9: TRADING
1) Organizations and individuals shall only be permitted to trade
gene-modified food when they have Certificate on product's standard
of such gene-modified food;
2) Organizations and individuals shall only be permitted to trade
gene-modified food when they have a certificate on registration of
business in this sector;
3) Organizations and individuals producing and trading gene-modified
food shall have to bear the responsibility before the law when they
implement not in accordance with the registered criteria.
ARTICLE 10: INFORMATION AND ADVERTISEMENT
1) Organizations and individuals shall only be permitted to carry
out advertisement when they have a Certificate on products'
standards with respect to gene-modified food as issued by the
Department of Food Safety and Hygiene.
2) The advertisement of gene-modified food must comply with the
ARTICLE 11: LABELING
1) Labeling gene-modified food shall be conducted in accordance with
the current regulations on Labeling domestically-circulated goods
and imported, exported goods.
2) The contents of gene-modified food labeling shall be as follows:
a) Gene-modified food is equivalent to normal food with respect to
ingredients, nutrition value and content of substances.
Modified Protein left in products: Compulsory labeling. Modified
DNA left in products: Compulsory labeling.
Modified Protein not left in products: not subject to compulsory
Modified DNA not left in products: Not subject to compulsory
b) Gene-modified food is different from normal food with respect to
ingredients, nutrition value and content of substances.
c) Example of labeling:
With respect to foods containing only one ingredient, the words
"gene-modified" must be recorded with the name of the product or
must be put into brackets right after the name of gene-modified
ingredient as listed in the composition.
GENE-MODIFIED MAIZE OR MAIZE (GENE-MODIFIED):
With respect to foods containing more than one ingredient, the label
of the product must be recorded with words of "gene-modified"
together with name of the gene-modified ingredient or must be put
into brackets right after the name of gene- modified ingredient as
listed in composition.
Composition: Skimmed milk powder; maize starch (gene-modified);
glucose; soy-bean powder; citric acid; Salt; Vegetable oil; Vanilla
3) The contents as announced in the label must be put at the
position so that they can be realized easily and they must be
HANOI 00000064 004.2 OF 004
presented clearly, straightforward, readably with naked eye, and the
dimensions and space of words must be reasonable, the size of the
words must equal to the size of words of ingredient names.
ARTICLE 12: SUPERVISION
1) State body in charge of food hygiene and safety shall supervise
gene-modified food being circulated and sold in the market.
2) Organizations and individuals shall be responsible for notifying
the State body in charge of issuance of Certificate on products'
standards with respect to gene-modified food any technical
information or newly applied science, which affects to the safety of
constituents used in processing food and prohibition or limitation
relating to gene-modified food.
ARTICLE 13: SUSPENSION OF CIRCULATION
Suspension of circulation of gene-modified food shall be implemented
in accordance with the current regulations as applicable to other
normal products. Besides, inspecting and examining body shall
announce to return or withdraw gene-modified food if any one of the
following issues happens:
1) Gene-modified foods is declared as gene-modified one, however,
the gene-modified element is discovered contrary to what has been
2) Gene-modified food is declared as not gene-modified one, however,
the gene-modified element is discovered after inspection.
3) When there is evidence of management body that gene modified food
already issued with a Certificate on products' standards with
respect to gene-modified food has danger to people's health,
animals' health and the environment, the Certificate on products'
standards must be suspended or amended promptly.
CHAPTER V: IMPLEMENTATION PROVISIONS
ARTICLE 14: ORGANIZATION OF IMPLEMENTATION
1) Department of Food Safety and Hygiene - the Ministry of Health
shall be responsible for carrying out, examining, inspecting and
supervising the implementation of these regulations;
2) Health Departments of provinces and cities under central
authorities, relevant health agencies shall be responsible for
organizing the implementation, directing, inspecting, examining and
supervising units producing and trading gene-modified foods during
the course of implementation of these regulations.
3) Organizations and individuals producing, trading and importing
gene-modified food shall be responsible for implementation of these
ARTICLE 15: DEALING WITH BREACHES
Organizations and individuals committing breaches of these
regulations shall be subject to disciplinary measures,
administrative penalty or investigation for criminal responsibility.
If they cause damage they shall have to make compensation for damage
in accordance with the law.