G/SPS/N/USA/2765  
 
8 June 2015  
(15-2974)  Page: 1/2  
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION 
1. Notifying Member: UNITED STATES OF AMERICA 
If applicable, name of local government involved:   
2. Agency responsible: US Food and Drug Administration (FDA) 
3. Products covered (provide tariff item  number(s) as specified in national 
schedules deposited with the WTO; IC S numbers should be provided in 
addition, where applicable): Human and animal food – HS Codes: 04, 07, 08, 09, 10, 
11, 12, 15, 16, 17, 18, 19, 20, 21, 22 
4. Regions or countries likely to be affected , to the extent relevant or practicable: 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document: Draft Guidance for Industry on the Voluntary Qualified 
Importer Program for Food Importers and Guidelines in Consideration of the Burden of the Voluntary Qualified Importer Program Fee Amounts on Small Business; Availability 
 
Language(s): English  Number of pages: 5 
http://www.gpo.gov/fdsys/pkg/FR- 2015-06-05/pdf/ 2015-13706.pdf  
http://members.wto.org/crnattachments/2015/SPS/USA/15_2271_00_e.pdf  
6. Description of content: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry  on the Voluntary Qualified Importer Program 
(VQIP) for importers of human or animal food. The draft guidance describes VQIP, which 
provides for expedited review and importation of food offered for importation by importers who voluntarily agree to participate in the program. The draft guidance 
describes the eligibility criteria for, and benefits of, participation in VQIP. The draft 
guidance also provides information on submitting an application for VQIP participation, obtaining a facility certification for the foreign supplier of a food imported under VQIP, the VQIP user fee, conditions that might result in the revocation of VQIP eligibility, and 
criteria for reinstatement of eligibility. FDA is issuing the draft guidance in accordance 
with the Federal Food, Drug, and Cosmetic Act (FD&C Act). 
FDA recognizes that there is significant international interest in how it is implementing 
the Food Safety Modernization Act of 2010 and as a result has elected to notify this 
action even though this notification is not an obligation under Article 7/Annex B of the WTO SPS Agreement. 
7. Objective and rationale: [X] food safety, [ ] animal health, [ ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [ ] protect territory from 
other damage from pests.   G/SPS/N/USA/2765 
 
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  8. Is there a relevant international st andard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text)   
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] International Plant Protection Convention (e.g. ISPM number)    
[X] None 
Does this proposed regulation conform to the relevant international standard?   
[ ] Yes   [ ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language (s) in which these are available: 
Section 302 of FDA Food Safety Modernization Act as notified to the WTO SPS 
Committee as G/SPS/N/USA/2156 (available in English) 
10. Proposed date of adoption (dd/mm/yy) : Not applicable 
Proposed date of publication (dd/mm/yy) : Not applicable 
11. Proposed date of entry into force: [ ] Six months from date of publication , 
and/or  (dd/mm/yy) : To be determined. 
[ ] Trade facilitating measure   
12. Final date for comments: [ ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Although you may comment on any guidance at 
any time, to ensure that FDA considers your comments on this draft guidance before it 
completes a final version of the guidance, submit either electronic or written comments 
on the draft guidance by 19 August 2015. 
Agency or authority designated to hand le comments: [ ] National Notification 
Authority, [ ] National Enquiry Point.  Address, fax number and e-mail address 
(if available) of other body:  
Submit electronic comments on the draft guidance, including comments regarding the 
proposed collection of information, to http://www.regulations.gov . Submit written 
comments on the draft guidance, including comments regarding the proposed collection 
of information, to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 
13. Text(s) available from: [X] National Notifi cation Authority, [ ] National Enquiry 
Point. Address, fax number and e-mail address (if available) of other body:   
United States SPS National Notification  Authority, USDA Foreign Agricultural  
Service, International Regulations and Standards Division (IRSD), Stop 1014, 
Washington D.C. 20250; Tel: +(1 202) 720 1301; Fax: +(1 202) 720 0433; E-mail: 
us.spsenquirypoint@fas.usda.gov  
Text is also available in the Federal Register, Vol. 80, No. 108, Page 32136 or at: 
http://www.gpo.gov/fdsys/pkg/FR- 2015-06-05/pdf/ 2015-13706.pdf