WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/1873 
25 September 2008  
 (08-4528) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
 
NOTIFICATION 
 
1. Member to Agreement notifying:  UNITED STATES
  
If applicable, name of local government involved:     
2. Agency responsible:  US Food and Drug Administration 
3. Products covered (provide tariff item numb er(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where applicable):  Animals and food derived from animals 
4. Regions or countries likely to be affected, to the extent relevant or practicable :  All 
trading partners exporting geneti cally engineered animals or foods derived from such animals 
to the United States. 
5. Title, language and number of pages of the notified document:  Guidance for Industry;  
Regulation of Genetically Engineered Animals Containing Heritable rDNA  Constructs;  Draft 
Guidance (available in English, 25 pages) 
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 Description of content:  The draft guidance is intended to clarify FDA's requirements and 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draft guidance describes how the new animal drug provisions of the Federal Food, Drug, and 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 anim als and their FDA-regula ted products, including 
FDA's intent to exercise enforcement discre tion regarding requirem ents for certain GE 
animals.  
This draft guidance, when finali zed, will represent the FDA's curr ent thinking on the topic.  It 
does not create or confer any rights for or on an y person and does not operate to bind FDA or 
the public.  An alternative method may be used as long as it satisfies the requirements of 
applicable statutes  and regulations. 
It provides recommendations on how to comply w ith existing requirements,  but does not itself 
create any new obligations or requirem ents. Under existing law and implementing 
regulations, all foods from GE anim als, and with a few exceptions, all GE animals have to be 
approved prior to import, inters tate movement or marketing because they are considered to 
contain 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. 
7. Objective and rationale:  [ X ] food safety, [ X ] animal health,  [   ] plant protection, 
[ X ] protect humans from animal/plant pest or disease,  [   ] protect territory from other damage from pests    G/SPS/N/USA/1873 
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  8. International standard, guideline or recommendation:  
[ X ] Codex Alimentarius Commission, [   ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention, [   ] None  
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:  Codex Alimentarius Commission:  Guideline for 
the Conduct of Food Safety Assessment of F oods Derived from Recombinant-DNA Animals ;  
in ALINORM 08/31/34, Appendix II;  ( ftp://ftp.fao.org/codex/Alinorm08/al31_34e.pdf
).  The 
information recommended for review for food safe ty in the draft guidance is consistent with 
the information recommended for review in the Codex Guideline. 
9. Relevant documents and language (s) in which these are available:   Notice of Availability:  
US Federal Register, 73 FR 54407, 19 September 2008;  
http://www.fda.gov/OHRMS/DOC KETS/98fr/E8-21917.htm  
Guidance Information:  http://www.fda.gov/cv m/GEAnimals.htm  (available in English) 
10. Proposed date of adoption:  The final Guidance will be issued after FDA has reviewed all 
comments it receives during the 60-day commen t period and has made any revisions to the 
guidance as warranted.  
11. Proposed date of entry into force:  Because guidances in the Unit ed States do not create any 
requirements or obligations, ther e is no "entry into force". 
12. Final date for comments:  18 November 2008 
Agency or authority designated to handle comments:  [   ] National notification 
authority, [ X ] National enquiry point, or  address, fax number and E-mail address (if 
available) of other body: 
Submit written or electronic comments identi fied as Docket No. FDA-2008-D-0394, by any 
of the following methods: 
• Federal eRulemaking Portal:  http://www.regulations.gov    Follow the instructions for 
submitting comments. 
Submit written submissions in the following ways: 
• Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]:  Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. 
Instructions:  All submissions received must include the agency name and docket number for 
this rulemaking.  All objections received  will be posted without change to 
http://www.fda.gov/ohrms /dockets/default.htm  
Complete text can be also be found on the Internet at  
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 ba ckground 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.  G/SPS/N/USA/1873 
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  13. Texts available from:  [ X ] National notificati on authority, [   ] Na tional enquiry point, 
or address, fax number and E-mail address (if available) of other body: 
United States SPS National Notification Aut hority, USDA Foreign Agricultural Service, 
International Regulations and Standards Division (IRSD), Stop 1027, Washington D.C. 
20250;  Tel:  +(1 202) 720 1301;  Fax:  +(1 202) 720 0433;  E-mail:  
us.spsenquirypoint@fas.usda.gov