August 20, 2015
RAC, PS2 and ITSC Colleagues:
Here is a copy of PFI’s comment to FDA in response to FDA’s issuance of Draft Guidance related to the Voluntary Qualified Importer Program (VQIP). Thanks to those of you who provided input. The comment, submitted yesterday via regulations.gov, incorporates your input as well as consultation with AFIA, GMA and NGFA.
Our main points are the following: First, we urge FDA to consider a pre-arrival clearance mechanism for VQIP foods. Second, we recommend that VQIP be foreign facility-specific instead of imported food-specific. Similarly, we recommend that VQIP participants be able to import any foods from an appropriately certified foreign supplier (as opposed to having to specify which foods will be imported). We indicate that, absent these and other changes to VQIP, pet food makers and ingredient suppliers are unlikely to enlist in the program.
On a separate note, I received word from a FDA official/former colleague this past Tuesday that FDA will issue the preventive controls final rules for human and animal food on Tue, 1 Sep. I will share more information as it becomes available.
Finally, last Thu (13 Aug), PFI joined AFIA, NGFA and NRA in a meeting with the Office of Management and Budget (OMB) to reiterate a few concerns we still have regarding the FSMA animal food rule. Our focus during this conversation with OMB was on the costs of implementation and PFI’s main point was that FDA’s calculation of FSMA implementation costs a) is at odds with industry calculations and b) does not appear to take into account resources expended since 2007, well in advance of FSMA regulations but in preparation for their finalization and implementation. We also thanked FDA (CVM joined the meeting via teleconference) for their openness and willingness to engage with animal food stakeholders during the rulemaking process.