March 2012: The FDA's Latest Ruling is Effective Immediately. Should You be Worried?
The FDA published an Interim Final Rule (IFR) this week, that is effective immediately. It expands the scope of the records that the FDA (or its agents) can demand from a grower/shipper/retailer. Here's what you need to know:
- From the time of an official request, you must make information available as soon as possible. The deadline is within 24 hours.
- Records can be requested from up to 2 years in the past. This makes reliable electronic storage a necessity of any traceability program.
- The FDA must be able to identify the immediate previous sources (one-back) and immediate subsequent recipients of food (one-up) based on your records.
- The FDA can now request records for food that is not directly subject to a recall. It also can request food that it has "reasonable belief" of contamination. The FDA can also require copies of "complaint and adverse event records" and recall records in addition to your traceability information.
- The FDA can only request access to information. However, the penalty for denying access can be pretty stiff. The FDA can:
- Suspend your facility's registration, preventing you from importing, exporting or selling food
- Detain or seize the food
- Issue a mandatory recall order for the food (for which you may be charged)
- Initiate civil or criminal action
Here's the good news:
If you use the HarvestMark PTI solution, you're compliant with trace back requirements. The HarvestMark secure servers also take care of your data storage, back up, and failover needs. Even better, HarvestMark makes all of your packers' data automatically available on one platform, even if they are not integrated into your ERP system. Finally, any product complaints received using the HarvestMark feedback feature are securely stored for fast reporting for the FDA or otherwise.
If you've implemented the HarvestMark Hybrid Pallet Tag solution, you are also compliant with the trace-forward aspect of this new rule. Given a date range, Lot number, or pallet ID number, the HarvestMark solution returns the required information instantly from a secure web portal or our iPad app.
Have a question about the rule or Hybrid Pallet Tag? Contact us by email give us a call at 650.264.6200.
Here's the full text of the IFR for your reference.
The Return on Investment of PTI Compliance Just Got Better
There's been a lot of hand waving about the ROI (or lack thereof) from PTI compliance from various corners of the industry. Until recently, it's been focused on the benefits of quick response to a recall. However one of our customers, JemD Farms, is now leveraging data captured by their HarvestMark PTI solution into insights that drive sales and profits. JemD Farms provides a great example of the real insights that the HarvestMark PTI solution can deliver, even before retailers are scanning cases at DCs.
Each day, the HarvestMark system brings together production and traceability data from across JemD’s farms and distribution centers to provide users with on-demanddashboards that deliver insights about production and in-transit product. Using a PC or an iPad, JemD users can see the volume of inbound product by packer, identify the origin of any lot, and analyze historic production trends. Using these HarvestMark business intelligence tools, JemD Farms provides their sales desks with several days advanced notice of inbound product, allowing teams to optimize their sales motions, support adplanning, and give retailers better product visibility.
As Adrian Abbott, Director of Operations at JemD Farms points out, “We’ve been committed to PTI from the outset, but viewed it as pure cost. Using the HarvestMark business intelligence tools, we’re able to capture enterprise value from our traceability program.”
For more information on how HarvestMark has helped JemD realize value through traceability, read the JemD press release.