VZCZCXRO4711
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 
 
SIPDIS 
 
SIPDIS 
 
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 
GM foods. 
 
¶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 
ingredients; 
2) The following gene-modified food shall not be regulated by these 
regulations: 
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 
exported; 
 
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 
as follows: 
1) Gene-modified food is the food originated from gene-modified 
organisms or the ingredients of the food which are originated from 
gene-modified organisms. 
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 
supervision. 
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 
people's health. 
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 
regulations; 
c) Complying the periodical inspection in accordance with the 
current regulations; 
2) Name of establishments producing and trading gene-modified food 
must: 
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 
GENE-MODIFIED FOOD 
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: 
a) Non-allergy 
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 
FOODS 
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 
information: 
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 
normal food; 
e) Confirmation of stability of transplanted gene (until the sixth 
generation); 
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 
advertisement regulations. 
 
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. 
PROCESSED FOOD: 
Modified Protein left in products: Compulsory labeling.  Modified 
DNA left in products: Compulsory labeling. 
PROCESSED FOOD: 
Modified Protein not left in products: not subject to compulsory 
labeling. 
Modified DNA not left in products: Not subject to compulsory 
labeling. 
b) Gene-modified food is different from normal food with respect to 
ingredients, nutrition value and content of substances. 
COMPULSORY LABELING: 
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 
Flavoring. 
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 
registered. 
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 
regulations. 
 
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. 
 
END TEXT 
 
Michalak