Was the Reportable Food Registry (RFR) notified to World Trade Organization's Committee for Sanitary and Phytosanitary Measures (WTO SPS)?
On September 8, 2009, FDA implemented the RFR (Section 417 of the Food, Drug and Cosmetic Act), and the prohibited act provisions of the FD&C Act related to the Registry became effective on that date. Draft guidance was developed (Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007) and was notified to WTO SPS Committee in July 2009, with an addendum for the final guidance notified in September 2009.
When and how will the registry interface with Europe's Rapid Alert System for Food and Feed (RASFF), with the World Health Organization's INFOSAN (The International Food Safety Authorities Network), and with the International Health Regulations (IHRs)?
The RFR, RASFF, INFOSAN, and IHRs serve different purposes. The United States will continue to communicate with RASFF, INFOSAN, and the IHRs by established processes. There are no immediate plans to interface RFR with these programs. RASFF is intended to be an effective tool to exchange information about measures taken responding to serious risks detected in relation to food or feed. INFOSAN disseminates important global food safety information, and the IHRs are intended to help the international community prevent and respond to acute public health risks that have the potential to cross borders and threaten people worldwide.
What has the United States done to inform all the foreign firms that are currently shipping to the United States?
FDA notified foreign Embassies located in Washington, DC, about the RFR and invited them to attend the three public workshops prior to opening the electronic portal. The Department of State delivered a cable to notify Agricultural Attachés, State and Commerce Officers at all U.S. Embassies to ask them to notify the foreign regulatory counterparts and the industry in their region or country. FDA presented outreach to member countries of the World Trade Organization's Committee on Sanitary and Phytosanitary Measures to provide information and respond to questions on the RFR. The guidance documents have been translated into French, Spanish and Chinese.
Where is the RFR’s electronic portal located on the internet?
The electronic portal can be accessed at the Reportable Food Registry for Industry web page.
Where can I find out more information about the RFR?
FDA’s September 2009 guidance document discussing the RFR (Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007). In May 2010, FDA published a draft Edition 2 of this guidance document, including new draft Q&As specific to foreign facilities. This draft guidance provides answers to questions of international interest such as:
- Do the requirements of the Reportable Food Registry apply to foreign human food/animal food producers?
- Does FDA work with foreign governments when it receives a reportable food report about an imported or exported food?
- May a foreign public health official submit a reportable food report?