Re-registration of food facilities

FSMA (Food Safety  Modernization Act) is the new act signed by President Obama on Jan. 4th, 2012 so that it "enables FDA to better protect public health by strengthening the food safety system".  It amends the Section 415 of the Federal Food, Drug, and Cosmetics Act. It requires food production facilities, foreign or internal,  to register with FDA.

A comprehensive FAQ serve as a guide for facilities can be found in the FDA website at http://www.fda.gov/Food/FoodSafety/FSMA/ucm314178.htm. To a Vietnam packer, the most important work to do is to reregister his facility, which by this law once every 2 even years, starting from 2012 on. The time to register is from Oct 1 to Dec 31. Below are some items in this FAQ.

C.3.1 When does a facility need to start biennial re-registration if it is required to register with FDA under FDCA §415? 

FSMA amended FDCA §415 to provide that facilities required to register will have to re-register every 2 years, during the period beginning on October 1 and ending on December 31 in even numbered years. This will first occur in October-December 2012.

[This one is the most important one already mentioned above]

IC.3.3 What is FDA’s authority to suspend the registration of a food facility?
Section 415(b) of the Federal Food Drug and Cosmetic Act, as amended by the Food Safety Modernization Act Title 1, Section 102, for the first time explicitly provides FDA the authority to suspend by order the registration of a facility registered under section 415 in certain circumstances involving food manufactured, processed, packed, received or held by a registered facility that has a reasonable probability of causing serious adverse health consequences or death to humans or animals. FDA did not previously have a process for suspending the registration of a food facility in such circumstances.

[This is a new FDA right that can be executed when a facility register: it can suspend the registration based on the information it has about a facility].

IC.3.6 What is the effect of such a suspension?
If the registration of a facility is suspended, no person shall import or export food into the United States, offer to import or export food into the United States, or otherwise introduce food into interstate or intrastate commerce in the United States from such facility. This important authority will further help the FDA assure the safety and security of our nation’s food supply.

[This item explain what the effect if such suspension is issued to a particular facility: no shipment can be allowed to ship to the US].

IC.3.12 Does the Food Safety Modernization Act require a food facility to submit additional information to FDA in order for the facility to receive a food facility registration number?
Yes. Section 102 of FSMA amends section 415(a)(2) of the Federal Food, Drug, and Cosmetic Act by requiring food facilities to submit registrations to FDA containing additional information. Specifically, registrations are required to contain the e-mail address for the contact person of the facility, or for a foreign facility, the email address of the United States agent for the facility, and an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. Additionally, if determined necessary by FDA, registrations are required to contain information regarding other applicable food categories, as determined appropriate by FDA, for foods manufactured/processed, packed, or held at registering facilities.

[New registration requires additional information such as the email address of the contact person of the facility, its United States agent, and an assurance that FDA will be permitted to inspect the facility].

IC.3.13 Will food facilities already registered with FDA under section 415 of the FD&C Act be required to renew their registrations during the October 1 – December 2012 registration renewal period? 
Yes. All facilities that are required to register must renew their registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year. The first registration renewal cycle will be held from October 1 to December 31, 2012. Registrants are required to submit registrations to FDA containing the new information added by section 102 of FSMA. As new requirements and guidance go into effect related to facility registration renewal, FDA will post the information on this FSMA website. For more information on Food Facility Registration, please visit the FDA’s Food Facility Registration page.

[And to the facility already registered with FDA it is required to register by this new law.]

Above are some most important information for the reregistration of your facility with FDA this year. Be ready to register when time comes.