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Exemptions in FSMA Rules Under Study

Almond Board of California staff continue to plow through the two rules proposed under the Food Safety Modernization Act that are titled:

  1. Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety Rule)
  2. Current Good Manufacturing Practices and Hazard Analysis and Risk-Based Preventive Controls for Human Food (GMPs and Preventive Controls)

Recent efforts have focused on a better understanding of “who’s in and who’s out,” according to the proposed exemptions within both rules. Although the proposed exemptions are fairly straightforward, there is much that is left to interpretation. To complicate things somewhat, certain size-of-operation exemptions apply to both growers and handlers; however, the size-of-operation (number of employees, or annual sales) limits proposed are not necessarily the same for growers and handlers. Below is a summary chart of the proposed exemptions, showing whom they may apply to:

Proposed Exemptions
Exemption applies to:
Notes
Produce Safety Rule (affects growers)
Preventive Controls Rule (affects handlers/huller shellers)
Qualified Exemption: Average annual sales less than $500,000 and at least 1/2 of those sales being direct (within same state or 275 miles)
Yes
Yes
Modified requirements apply if exempt
Very small businesses (qualified facilities):
Option 1 - Less than $250,000
Option 2 - Less than $500,000
Option 3 - Less than $1,000,000
No
Yes
Modified requirements apply if exempt
Low-risk, on-farm and low-risk, mixed-type activities performed by small business defined as <500 employees
N/A
Yes
Small and very small on-farm businesses conducting these low risk activities would be exempt from most of the rule's requirements

Low-risk activities would be defined for the exemption, including the specific foods to which they relate (such as re-packing intact fruit and vegetables, or grinding/milling/cracking/crushing grains

Per FDA: The key is that facilities must be "on farm." Note that shelling is considered part of harvesting if done on a farm's own RACs
Low-risk, on-farm and low-risk, mixed-type activities performed by very small business (see monetary thresholds above)
N/A
Yes
Farms or mixed-type facility with annual sales <$25,000
Yes
No
Produce that receives commercial processing "kill" step Yes No Per FDA: The farm would have to keep documentation of the identity of the recipient that performs the commercial processing

Handlers will be affected by the Preventive Controls rules. Even if a handler qualifies for an exemption, Good Manufacturing Practices will apply and other modified requirements may be required.

In the coming weeks, we will continue to review the proposed rules and work with industry to formulate fact-based comments. We welcome your input in this process. Please contact Tim Birmingham to provide input.

Please note: Growers and handlers should review the rules individually and consult with expert counsel for the specific needs of their own operations.

Definitions:
Farm: A facility in one general location devoted to the growing and harvesting of crops. Washing, trimming of outer leaves of, and cooling produce are considered part of harvesting. The term “farm” includes a facility that packs or holds food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership.

Farm mixed-type facility: An establishment that grows and harvests crops or raises animals and may conduct other activities within the farm definition, but that also conducts activities that trigger the section 415 registration regulations.

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