Darren S. HigginsTom O'Brien, Produce Marketing AssociationAs the dust settles after the U.S. Food and Drug Administration’s announcement of the Food Safety Modernization Act proposed rules on produce safety and preventive controls, Produce Marketing Association members are asking questions as numerous as there are pages in the published proposals.
Because the produce proposal is foremost in many industry members’ minds, I’ll address some questions PMA members have asked most pertaining to this rule.
Other proposals, such as the preventive controls rule and future proposals on import issues, third-party accreditation, and record keeping (including traceability), will demand your attention as well.
Perhaps the most important element to understand is that FDA’s proposals are just that — proposals.
Preceding the final rule is the current comment period, which closes May 16.
This is a critical time in the rulemaking process. Assess the proposals’ impact on your operation. Discuss with your colleagues what in the proposals works and what does not work.
Raise concerns and potential solutions to FDA through the comment process or to your association, such as PMA, which will then provide comment to FDA on members’ behalf.
What qualifies as an exemption?
Produce typically cooked or that undergoes a kill step would be excluded.
Remaining exemptions would be determined by the average annual value of all food — not only fruits and vegetables — from a particular farm, based on a rolling three-year average.
Farms with an average annual food value of $25,000 or less would be exempt. A “qualified exemption” would exist for farms with an annual food value of $500,000, where at least half the receipts came from sales directly to consumers or to restaurants or retail within the same state or within 275 miles.
Does the proposed rule apply to imports?
Would the proposed produce rule require written food safety plans?
What would it require?
In the proposal, FDA defined specific targets for critical food safety components.
Those components include water intended or likely to contact produce; personnel qualifications, training, health; biological soil amendments of animal origin; domesticated and wild animals in the growing area; and equipment, tools, building and sanitation.
The proposal would require that a grower comply with and be able to demonstrate compliance with those targets.
The rule also proposes some recordkeeping requirements: what records must be kept, how long they must be kept, where they must be kept, and how they must be produced when required.