. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/USA/420 
24 September 2008 
 (08-4482) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   UNITED STATES
 
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   Food and Drug Administration (FDA) (431) 
Name and address (including telephone and fax numbers, e-mail and web-site 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be  indicated if different from above:         
3. Notified under Article 2.9.2 [  X ], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:         
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable):   Genetically engineered 
animals and products obtained from genetically engineered animals 
(ICS 07.080. 65.020, 67.020) 
5. Title, number of pages and langua ge(s) of the notified document:   Guidance for Industry: 
Regulation of Genetically Engineered Anim als Containing Heritable rDNA Constructs
 (2 pages, English) 
6. Description of content:   The draft guidance is intended to clarify FDA’s requirements and 
recommendations for producers and developers of  genetically engineered (GE) animals.  
The draft guidance describes how the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act apply with respect  to GE animals and their FDA-regulated 
products, including FDA’s intent to exercise en forcement discretion regarding requirements 
for certain GE animals.   
This draft guidance, when finalized, will repr esent the FDA’s current thinking on the topic.  
It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.  An alternative met hod may be used as long as it satisfies the 
requirements of applicable statutes and regulations. 
 
The draft guidance expl ains how existing technical regula tions and conformance assessment 
procedures pertain to genetically engineer ed animals and their products, and provides 
recommendations on how to comply with t hose technical regulations and conformance 
assessment procedures. It does not create any new legal obligations or requirements. Under 
existing law and implementing regulations, all foods from GE  animals, and with a few 
exceptions, all GE animals have  to be approved prior to im port, interstate movement or 
marketing because they are considered to c ontain new animal drugs. The recombinant-DNA 
construct contained in the GE animal and intended to affect its structure or function is a new animal drug under US law.  G/TBT/N/USA/420 
Page 2  
 
  Note: FDA has issued a Notice of draft guidance that provides nonbinding 
recommendations on how to comply with existing FDA technical regulations and 
conformance assessment procedures. The guidance itself is neither a technical regulation nor a conformance assessment procedure. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of animal health 
8. Relevant documents:    
73 Federal Register (FR) 54407 19 September 2008; Title 21 Code of Federal Regulations 
(CFR) Part 10.115. 
 In addition, guidance information can be found at URL:  http://www.fda.gov/cvm/GEAnimals.htm
 
 
Complete text can also be found at URL:  
http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm   
and insert Docket No. FDA-2008-D-0394.     
For access to the docket to read background documents or comments received, go to 
http://www.fda.gov/ohrms/dockets/default.htm   
and insert the Docket No. FDA-2008-D-0394 into the “Search” box and follow the prompts.  
Will appear in the Federal Register when adopted.   
9. Proposed date of adoption:   
Proposed date of entry into force:   }To be determined 
10. Final date for comments:   18 November 2008 
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:   
Internet URLs: 
http://edocket.access.gpo.g ov/2008/E8-21917.htm 
http://edocket.access.gpo.gov/2008/pdf/E8-21917.pdf