Proposed Rule: Good Manufacturing Practices and Hazard Analysis and Risk Based Preventive Controls for Human Food.
This is another proposed rule of the Food Safety Modernization Act which will affect some packinghouses, specifically operations that qualified for the FDA Food Facility Registration. Farms are exempt from this rule IF they grow and harvest produce in one general location, do not pack product from other farms and do not cut into the consumable portion of the product.
Much like the produce rule there are exemptions for the preventive controls rule based on total food sales for an operation annually. Remember that “total food sales” includes receipts for human or animal food sales – including chewing gum! Non-food item receipts should not be included in this total amount including Christmas trees, carving pumpkins, hay rides, corn mazes etc.
What farm operations who were required to register with the FDA are exempt?
1. If 51% or more of your total food sales are made directly to the consumer AND your operation brings in less than $500,000 of total food sales receipts annually
2. Any farm that qualifies as a very small business. “Very small business” has yet to be defined and comments to the FDA on the definition are strongly encouraged. Currently there are three definition options:
a. Option 1 – Average annual sales of less than $250,000
b. Option 2 – Average annual sales of less than $500,000
c. Option 3 – Average annual sales of less than $1,000,000
3. If your operation qualifies as a “very small business” and your activities qualify as “Low Risk” which could include: re-packing intact fruits and vegetables, grinding/milling/cracking/crushing grains
Unlike the FSMA Produce Rule the Preventive Controls Rule does require qualifying farms to have a written food safety plan in place.
This plan would need to include:
• Written hazard analysis
• Written preventive controls
• Written procedures, and the frequency with which they are to be performed, for monitoring the implementation of the preventive controls
• Written corrective action procedures
• Written verification procedures
• Written recall plan
More information on the proposed Preventive Controls rule can be found at the FDA FSMA website, and includes a fact sheet and Q&A documents. http://www.fda.gov/Food/guidanceregulation/FSMA/ucm334115.htm
The comment period for this proposed rule is open until September 16, 2013.
