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; ICS 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Title of the notified document: Draft Guidance for Industry on the Voluntary Qualified Importer Program for Food Importers and Guidelines in Consideration of the Burden of the Voluntary Qualified Importer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Description of content: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry on the Voluntary Qualified Importer Program (VQIP) for importers of human or animal food. The draft guidance describes VQIP, which provides for expedited review and importation of food offered for importation by importers who voluntarily agree to participate in the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 The draft guidance describes the eligibility criteria for, and benefits of, participation in VQIP. The draft guidance also provides information on submitting an application for VQIP participation, obtaining a facility certification for the foreign supplier of a food imported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 FDA is issuing the draft guidance in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).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.  

8.

Is there a relevant international standard? 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 handle 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 Notification 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