Tom O'Brien, Produce Marketing Association
Tom O'Brien, Produce Marketing Association

As 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.

Are there traceability requirements in the produce rule?

No. Traceability proposals will come later in a proposal on recordkeeping.

The recordkeeping components in the proposed produce rule are not traceability proposals. Before traceability proposals can be made, FDA must report on a traceability pilot project. It was completed last June, and its report to Congress on the findings is still pending.

Until FDA’s final traceability requirements are released, existing U.S. traceability regulations requiring many companies to trace products one step forward and one step back per the Bioterrorism Act of 2002 remain in force.

What now?

No changes need to be made now. Instead, educate yourself and assess how this proposal will affect your business, then let FDA know your thoughts through the comments process.

To help you understand the rule, PMA has made a wide range of tools and information openly available through its FSMA Resource Center.

Of note, summaries of the proposed produce rule and the proposed preventive controls rule can be found there to help you understand the potential impact on your operation.

However, it is important that all companies continue to develop and update robust food safety programs, even as this regulatory process plays out.

Our industry and your company cannot afford to put food safety on hold pending final regulations and enforcement timelines, some of which will be up to six years from the date of the final rule.

Consumer confidence in our industry and its products are essential to our success, and demonstrable food safety is a key component to building that confidence.

Several years from now FDA will enforce final rules developed from these proposals and comments.

Dialogue among stakeholders and with your trade associations will help provide FDA with comments by the May 16 deadline to ensure all final rules incorporate the highest level of food safety to protect consumers in ways practical and efficient for industry members across the supply chain.

Tom O’Brien is the Washington, D.C., representative of the Newark, Del.-based Produce Marketing Association.

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