For industry members, education and information about U.S. Food Safety Modernization Act
(FSMA) final rules, guidance and training opportunities are crucial. For PMA, it is critical that we persevere on our Issues Leadership work to assure these new regulations achieve their stated food safety objectives and are practical for our industry members to implement. It also means helping our members learn how to implement and comply with FSMA.
With those objectives in mind, here are some important updates on FSMA we’ve been working on this last quarter of 2016:
Voluntary Qualified Importer Program (VQIP) final guidance issued
The U.S. Food and Drug Administration’s (FDA) final VQIP guidance
delivered no surprises. This final guidance confirms participation in VQIP is voluntary and requires an annual fee; the last proposed application fee by FDA was $16,400 per annum for businesses. FDA will not refund the VQIP user fee for any reason—even if the firm’s application to participate in VQIP is denied by the agency, a point PMA requested clarification on in our comments on the draft VQIP guidance
PMA also urged FDA to consider allowing more than 200 participants in the first year of the VQIP program. While it is understandable the agency wants to implement this program in a systematic and increasing manner over time, it is imperative that some firms are not provided with unfair marketplace competitive advantage. Specifically, PMA requested clarification around what criteria will be used to determine which firms are allowed to participate, and which firms will be denied access to VQIP. Given that FDA clears 12 million line-entries to 88,000 consignees receiving food shipments each year, 200 participants in VQIP its first year will be infinitesimally small compared to the overall food import volume. Unfortunately, the final guidance issued does not indicate whether FDA will open the program to more than 200 participants. This remains a point of clarification PMA will continue to pursue on behalf of our members.
for imported foods is particularly important for the fresh fruit and vegetable industry as produce imports increasingly supplement the U.S. supply of horticultural crops and products. Nearly 50 percent of fresh fruit and 20 percent of vegetables are imported to the U.S. Presentation materials
from FDA’s recent webinar covering the final VQIP guidance help explain fundamentals of the program.
PMA hopes that the expedited entry brought about by VQIP will speed border crossings by reducing bottlenecks and facilitate international trade, while also providing buyers and consumers with assurances that produce entering the U.S. has been safely grown, packed, processed and held under standards that are comparable to produce that has been domestically grown, packed, processed or held.
Status of other FSMA guidances
There are many additional FSMA draft guidance documents important for industry implementation and compliance with the numerous final FSMA regulations still pending. However, three important FDA FSMA draft guidance documents for industry have already been published:
These FDA FSMA guidance documents are currently being reviewed by members of the PMA Science & Technology Committee in preparation to provide comments back to FDA regarding these draft guidance documents. It is unclear as to when other anticipated draft FDA guidance documents will be released. It is also unclear whether FSMA will repealed, amended or allowed to be finalized as currently formulated, as this will be determined by the next Congress and the new U.S. Presidential administration. The PMA Issues Leadership team will keep you abreast of the any breaking developments on FSMA implementation.
FSMA training schedule resource now available
We now offer one-stop shopping for PMA members who need mandatory FSMA training on the various implementing regulations that their businesses are subject to.
This FSMA training calendar
connects members with ongoing training courses they need for the Produce Safety Rule
and the Preventive Controls for Human Foods
, as well as sprout-specific training through the Sprout Safety Alliance. Training courses for other rules, such as the Foreign Supplier Verification Programs
, are currently under development and will be posted to the alliance websites and here as new course offerings become available.
If you’re aware of other produce-specific FSMA training available to the public useful to include in this calendar, please email Johnna Hepner
, PMA director of food safety & technology, so we can connect PMA members to these additional opportunities.