National Editor Tom KarstThe topic of the FDA (re)registration of food facilities is drawing some notice in the trade, since Oct. 1 marks the start of a new registration period. The FDA's page explaining the specifics of the registration process is found here.
Another FDA Frequently Asked Questions summary page talks of what new wrinkles the Food Safety Modernization Act brings to the registration process and is found here. Unfortunately, some guidance to the industry on registration of food facilities has been held up in rulemaking and is not yet available. What the FDA does say is found on the FAQ page.
Some excerpts from that page:
Frequently Asked Questions on Registration and Registration Renewal
IC.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.
IC.3.2 What are other key provisions relating to compliance?
The legislation provides FDA authority to suspend a facility’s registration under certain circumstances, which would prevent that facility from introducing any food into commerce in the U.S., including importing or exporting food into the U.S. It also provides more flexibility for FDA in using its administrative detention authority to keep potentially adulterated or misbranded products from entering the marketplace.
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.
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.
IC.3.15 Am I required to renew a food facility registration online?
No. Registrants can renew food facility registrations online or submit the paper Form 3537 by mail or fax. A business with multiple facilities may also register on a CD-ROM by mail. FDA encourages online registration as the least costly, quickest, and most efficient means for food facility registration. With online registration, a food facility must enter all of the required information before the system will accept the submission. After all required information has been entered, a registrant will receive confirmation of registration and a registration number. Paper registration is a more costly and less efficient process to supply FDA with registration information and to provide food facilities with their registration numbers. Further, paper registration may have a higher number of errors or omissions on the form, which may require additional time to complete the registration process.
IC.3.16 Why wait until October 1, 2012 to start the registration renewal process?
The FDA Food Safety Modernization Act (FSMA) mandates that all food facilities that are required to register must renew their registrations every other year during the period beginning on October 1st and ending on December 31st of each even-numbered year. The first registration renewal cycle will occur from October 1 to December 31, 2012.
IC.3.17 What changes were made to the “Guidance for Industry: Necessity of the Use of Food Product Categories in Registration of Food Facilities”? NEW
FDA updated this guidance document (see the new draft verion Draft Guidance for Industry: Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories) to specify additional food categories to be included as mandatory fields in the food facility registration form, as provided by section 102 of the FDA Food Safety Modernization Act (FSMA). The updated guidance notes that the list of additional food categories includes food categories that are currently included on the food facility registration form as optional fields, including food categories for animal consumption. This guidance also describes certain FSMA amendments to section 415(a) of the Federal Food, Drug, and Cosmetic Act, which provide that, when determined necessary by FDA “through guidance,” a registrant must submit a registration to FDA containing information necessary to notify FDA of the general food category (as identified in 21 CFR 170.3 or any other food categories, as determined appropriate by FDA, including by guidance) of any food manufactured, processed, packed, or held at such facility. This guidance was renamed “Guidance for Industry: Necessity of the Use of Food Categories in Food Facility Registration and Updates to Food Categories.”
IC.3.18 Why did FDA make changes to “Guidance for Industry: Necessity of the Use of Food Product Categories in Registration of Food Facilities”? NEW
FDA believes that information about the food categories of foods manufactured, processed, packed or held at food facilities is a key element to allow for rapid communications between FDA and facilities directly impacted by actual or potential bioterrorist attacks, other food-related emergencies, or food safety incidents. Information about the categories of food a facility handles currently assists FDA in conducting investigations and surveillance operations in response to food-related emergencies. These categories also enable FDA to quickly alert facilities potentially affected by such an incident if FDA receives information indicating the type of food affected. The proposed additional food categories enhance the agency’s ability to respond quickly and accurately to an actual or potential bioterrorist incident or other food-related emergency. See the updated guidance, Draft Guidance for Industry: Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories, for more information.
Guidance and Rules
Draft Guidance for Industry: Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories
FDA updated this guidance document to propose additional food categories to be included in the food facility registration form as mandatory fields, including food categories that are currently included on the food facility registration form as optional fields.
Upcoming Guidance for Industry on Food Facility Registration
Three other updated food facility registration guidance documents will be released later this year to further clarify the process.
TK: The FDA's suspended animation in reference to FSMA rulemaking is a disservice to the industry. More detail is needed to bring certainty to the process for all involved.