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Regulations Requiring Domestic, Foreign Food Facilities To Register With FDA Finalized
The US Food and Drug Administration (FDA) this week published a final rule that amends its regulations that require domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the US to register with FDA.
FDA said these amendments to its food facility registration rules will further enhance its capabilities with respect to responding to food safety issues and, in addition, provide the agency with information that it can use to focus and better utilize its limited inspection resources.
This final rule is part of FDA’s implementation of the Food Safety Modernization Act (FDA). Section 102 of FSMA amends section 415 of the Food, Drug, & Cosmetic Act by requiring that certain additional information be included in facility registrations.
Specifically, FSMA requires that registrations for domestic food facilities are required to contain the email address for the contact person of the facility, and registrations for foreign food facilities are required to contain the email address of the US agent for the facility.
Further, the FSMA provides that food facilities required to register with FDA must renew their registrations with the agency every two years, betwen October 1 and December 31 of each even-numbered year, by submitting registration renewals to FDA. And the FSMA provides that all food facility registrations are required to contain an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the Food, Drug, & Cosmetic Act.
These FSMA amendments were self-implementing and became effective upon enactment of FSMA. These amendments are included in this final rule to codify the provisions in 21 CFR part 1, subpart H.
In addition, the FSMA authorizes FDA to require that all food facility registrations be submitted to FDA in an electronic format; however, that requirement cannot take effect before the date that is five years after the date of enactment (i.e., January 4, 2016).
FDA is implementing this provision of the final rule. However, the agency is delaying the date for mandatory electronic registration until January 4, 2020.
Further, FDA is including a waiver request provision in the rule to allow a registrant to submit a written request to FDA that explains why it is not reasonable to submit the registration, registration renewal, update, or cancellation to FDA electronically, or to explain why it is not reasonable to provide the email address of the owner, operator, or agent in charge of the facility.
FDA is also making changes to improve the utility of the food facility registration database; specifically, the agency is making changes to: require certain additional data elements in food facility registrations (e.g.. Send me more information