U.S.-China Sign 5 Year Agreement on Food and Feed Safety (Affects Pet Food, Vegetable Protein, Aquaculture, Etc.)

(The agreement was signed in advance of the third session of the U.S.-China Strategic Economic Dialogue⁴. At the same time, HHS and AQSIQ signed a similar agreement on drugs and medical devices. See future issues of ITT for a BP summary of the agreement on drugs and medical devices. See today's ITT, 07121320 for BP summary of the outcomes from the latest meeting of the U.S.-China Joint Commission on Commerce and Trade (JCCT).)

Agreement Initially Covers Pet Food, Vegetable Protein, Aquaculture, Etc.

The agreement will be implemented in a phased approach, beginning with the following products which have high import refusal rates and associated risk:

pet food/pet treats of plant origin or animal origin;

ingredients of food and feed (i.e. vegetable proteins such as wheat gluten and rice protein) (See ITT's Online Archives or 05/01/07 news, 07050105, for BP summary of the Food and Drug Administration's (FDA's) detention of vegetable protein products from China for animal or human use.);

all aquaculture farming products other than molluscan shellfish (See ITT's Online Archives or 07/02/07 news, 07070210, for BP summary of the FDA's retention of certain farm-raised Chinese fish and seafood) ; and

low-acid canned products or acidified food.

After evaluation of the outcomes of these programs, the list of covered products can be expanded to include additional covered products.

China to Issue Certificates for Shipments That Meet HHS/FDA Requirements

If AQSIQ determines that a shipment of the four covered product categories for export to the U.S. meets HHS/FDA requirements, it will issue a certificate that contains a unique identifying number and attests that the shipment meets HHS/FDA requirements. The exporter should provide the certificate's identifying number to the importer of record or to any intermediate party responsible for transmitting entry filing information to the importer of record in the U.S.

AQSIQ shall immediately revoke a certificate of any such shipment if it determines that it does not meet HHS/FDA requirements. AQSIQ may base a revocation of a certificate on inspection or testing results or any other information that comes to the attention of Chinese or U.S. authorities to indicate that the product does not meet HHS/FDA requirements. AQSIQ shall notify HHS/FDA of any revocation within three calendar days of the revocation.

Work to develop electronic or other secure system. To avoid counterfeiting of certificates or the falsification of information, within sixty calendar days of the date of entry into force of the agreement, AQSIQ and HHS/FDA will designate technical experts to work together to develop the technological capabilities to implement a secure electronic system or other secure means to transmit certificate and to receive information.

Possible future third-party testing/certification. The Parties may discuss in the future amending the agreement to reflect the role of recognized third party testing and certification in promoting product safety.

China to Register/Monitor Establishments That Meet HHS/FDA Requirements

The agreement states that with regard to the covered products for shipment to the U.S., China's AQSIQ will ensure it registers only establishments that meet HHS and FDA requirements. Among other things, AQSIQ must monitor each registered establishment and conduct annual inspections to ensure that they continue to meet HHS/FDA requirements.

Establishments have 3 days to notify AQSIQ of contamination, etc. AQSIQ will require its registered establishments to notify AQSIQ within three calendar days of detection of any failure to meet HHS/FDA requirements or of any contamination, major defect, or any other safety concern with regard to a covered product for export to the U.S. AQSIQ will transmit any such notification to HHS/FDA within three calendar days of the time it receives the notification. HHS/FDA shall transmit such notification to the U.S. Department of Homeland Security's Customs and Border Protection as appropriate.

Mutually Agreed U.S. Audits of Registration Program, Etc.

Upon agreement by both Parties, AQSIQ shall facilitate periodic audits or reviews of the AQSIQ registration program by HHS/FDA.

In addition, the agreement provides that HHS/FDA may request AQSIQ to conduct an investigation regarding any covered products exported from the customs territory of China that HHS/FDA has reason to believe may pose a health or safety risk to public health or safety of U.S. citizens.

AQSIQ shall respond to HHS/FDA within three calendar days of receipt of such a request and shall promptly conduct a thorough investigation.

¹On the last day of the five-year period, and of each subsequent five-year period, the Agreement shall automatically be renewed for another five-year period, unless either Party notifies the other Party that it wishes to terminate the Agreement. In addition, either Party may terminate the Agreement upon sixty calendar days' written notice to the other Party.

²"Food" is defined as articles under the jurisdiction of both Parties that are used for food or drink for humans, including articles used for components of any such article.

³"Feed" is defined as articles under the jurisdiction of both Parties that are used for food or drink for animals other than humans, including articles used for components of such article and including vitamins or herbs meant to supplement the diet not regulated as drugs. Feed includes feed ingredients, feed additives, and feed that contains veterinary drugs, whether processed, semi-processed, or raw.

⁴According to the U.S. Trade Representative, the SED is a forum designed to provide an overarching discussion of ongoing bilateral economic issues, cross-cutting issues, and long-term strategic challenges.

U.S.-China Agreement on the Safety of Food and Feed (dated 12/11/07) available at http://globalhealth.gov/news/agreements/ia121107b.html

Fact Sheet on the agreement (dated 12/11/07) available at http://www.hhs.gov/news/facts/foodfeed.html