RESTRICTED  WORLD TRADE  
ORGANIZATION  WT/ACC/CGR/27/Add.1 
25 January 2008 
 
 (08-0374) 
Working Party on the 
Accession of Montenegro Original:   English 
 
 
 
ACCESSION OF MONTENEGRO 
 
Additional Questions and Replies  
 
Addendum  
 
Comments on Certain Laws from the Republic of Montenegro 
  
 The following submission, dated 21 January 2008, is being circulated at the request of the 
Delegation of the Republic of Montenegro.   
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- Law on Genetically Modified Organisms 
Question 1 We thank the Government of the Republic of Mont enegro for the opportunity to comment on its 
legislation on genetically modified organisms.  Regarding genetically modified organisms, we 
are concerned that the systems for registering  and the requirements for commercializing may 
be overly-costly and burdensome.  Such costs coul d function as barriers to trade.  Once declared 
safe for placing on the market, use of the product should be free of restrictions.   We encourage 
Montenegro to adopt measures consistent with  international standards.  Tests for risk 
assessment should utilize clearly testable scientific hypotheses and testing should include those 
tests minimally necessary to iden tify and assess clearly identifi able risks from the use of a 
product.  
Chapter II, Article 7:  We recognise that a competent organization will provide a risk 
assessment for the application process for individua l biotech products.  Will Montenegro accept 
test results from other competent organizations? 
Answer:
 
The Ministry of Agriculture, Forestry and Water Ma nagement has prepared the draft of the new Law 
on Genetically Modified Organisms, which has been  approved by the Government of Montenegro on 
its session on 20 December 2007.  The draft is now in the phase of public discussion.  In accordance 
with this draft, test results of other competent organizations will not be accepted. 
Question 2 
Chapter II, Article 10:  Does Montenegro intend to apply the regulation and risk assessment to 
a single biotech event (transformed plant line) or to every food, feed or seed product that might 
be derived from the genetically-engineered plant? 
Answer:  
In accordance with the draft of the new Law on Gene tically Modified Organisms, risk assessment and 
the regulations will apply to every food, feed, or seed product that might be derived from the 
genetically-engineered plant. 
Question 3 
Chapter VI, Article 26:  What is the basis for im posing a fine rather than simply not processing 
the application when an applicant fa ils to meet application requirements? 
Answer:  
In accordance with the draft of the new Law on Gene tically Modified Organisms there is no fine for 
the applicant who did not meet the requirements.  Under the law that regulates general administrative procedure, the application is refused if the applicant does not meet the requirements .  WT/ACC/CGR/27/Add.1 
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  - General Comments on Animal and Plant Health Legislation 
Question 4 We appreciate the opportunity to provide commen ts on Montenegro’s animal and plant health 
legislation.  We are pleased with the legislatio n related to food safety, and look forward to 
reviewing the implementing legislation.  Ou r concern rests primarily with the Ordinance 
on Bovine Spongiform Encephalopathy (BSE).   
BSE Guidance:  Montenegro, under its Ordinanc e on BSE, does not allow live animals and a 
variety of beef and beef products from countries  that have had occurrences of BSE.  However, 
the OIE Terrestrial Animal Health Code (OIE Co de) clearly states that trade in such products 
can occur.   
The OIE Code aims to assure th e sanitary safety of international trade in animals and their 
products.  This assurance is achieved through th e detailing of health measures to be used by the 
veterinary services or other competent author ities of importing and exporting countries in 
establishing health regulations for the safe importation of animals and animal products. 
On 22 May 2007, the OIE adopted the recommendation that the United States be recognised as 
a "controlled" risk country with regard to BSE.   This OIE controlled risk classification 
provides an objective international definition of the science-based mitigation measures that the United States should follow to effectively manage any BSE risk.  The United States regulatory controls in place since January  2004 are consistent with th ose identified by the OIE and 
sufficient to permit the United States beef and beef  products from cattle of all ages to be traded 
safely in accordance with international guidelines.  Article 2.3.13.11 of the OIE Code provides 
the following guidelines for the certification of f resh meat and meat products from cattle from 
controlled risk countries, zones, or compartments: 
- The cattle from which fresh meat and meat products were derived passed ante-mortem 
and post-mortem inspections; 
- The cattle from which fresh meat and meat products are derived were not subjected to a 
stunning process, prior to slaughter, with a device injecting compressed air or gas into 
the cranial cavity, or to a pithing process; and 
- The fresh meat and meat products were produced and handled in a manner which 
ensures that such products do not contain a nd are not contaminated with specified risk 
materials as defined in items 1 and 2 of Article 2.3.13.14 of the OIE Code, or mechanically separated meat from the s kull and vertebral column from cattle over 
30 months of age. 
Ordinance on Undertaking the Measures to Prevent Introduction of the Animal Infectious 
Disease Bovine Spongiform Encephalopathy (BSE) in the Republic of Montenegro 
(OG RM 23/2005): 
1. Article 1 and 2:  We are concerned th at the law on BSE is inconsistent with 
OIE standards.  While imports of beef a nd beef products may be banned from any 
countries that have had occurrences of BSE,  Montenegro’s BSE law overstates the OIE 
position by banning all beef and beef produc ts.  Is there an exception for controlled risk 
countries? 
2. Article 2, paragraph 3:  Does Montenegro  allow for risk assessments conducted by the 
OIE for countries that have submitted dossiers? WT/ACC/CGR/27/Add.1 
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  3. Article 4, paragraph 10:  Montenegro i ndicates that meat is acceptable only from 
animals under 24 months of age that have been tested for BSE.  Is this 100 per cent testing?  Requiring testing at 100 per cent is inconsistent with OIE guidelines and may serve as a barrier to trade. 
4. Article 7, paragraph 2:  What is the basi s for requiring trace-back of animals to the 
mothers?  Is traceability to the herds sufficient? 
5. Exhibit 1:  Please explain why both OIE negligible and controlled risk countries are 
listed in category 1. 
Answer:
 
The Ordinance on Undertaking the Measures to Prev ent Introduction of Animal Infectious Decease 
Bovine Spongiform Encephalopathy (BSE) in the Republic of Montenegro (RM Official 
Gazette No.23/05) will be amended in accordance with OIE standards and recommendations by the 
end of February 2008 and subsequently s ubmitted to the Working Party for review. 
 
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