David Gombas, United Fresh Produce Association
David Gombas, United Fresh Produce Association

Because imports account for a sizable portion of our nation’s fruit and vegetable supply the Food and Drug Administration’s newly released draft rules under the Food Safety Modernization Act promise to have an enormous effect on the safety of fresh produce.

The new proposed rules, released in late July, address foreign supplier verification and accreditation of third-party auditors, both of which are critical elements of our nation’s produce safety system.

With the release of the draft rule for imported foods, we have become increasingly concerned about FDA’s exemption for small farms.

United Fresh supports adherence to common food safety standards by all produce suppliers to help ensure a consistently high food safety standard for all fresh produce sold to U.S. consumers.

That precept about consistent standards is why we’ve objected to the exemption for small farms in the proposed rules. The FDA’s draft Produce Safety Rule would not cover farms that have an average annual value of food sold during the previous three-year period of $25,000 or less.

This small-farm exemption amounts to a loophole in the proposed regulatory framework of our food safety law — not just for farms in the U.S., but for the farms in other countries that export to our market.

On a global scale, especially with small farms being significantly more prevalent in other production regions, that’s a substantial portion of imported fresh produce that will be exempted from the regulation.

It’s a gap in FSMA’s effectiveness for domestic production. It’s an enormous breach of the FSMA standards for imported foods.

Like I’ve said before at industry conferences and in dialogue with FDA officials, pathogens don’t know what size operation they’re on.

Equal rules

Back in 2007, when the United Fresh board of directors advocated to the FDA for mandatory, risk-based, commodity-specific produce safety standards, the vision was to adopt standards that were applicable to all produce, grown domestically or imported.

That fundamental principle was what we advocated to Congress in support of the Food Safety Modernization Act.

Add to this the logistical challenge of ensuring the verification of third-party auditors around the world.

According to the draft rule, “a foreign government, agency of a foreign government, foreign cooperative, or any other third party may seek accreditation from a recognized accreditation body (or, where direct accreditation is appropriate, the FDA) to conduct food safety audits and to issue food and facility certifications.”

Accreditation of third-party auditors is critical to upholding consistent food safety standards for U.S. produce consumers, and it’s equally important for domestic fruit and vegetable production and production in all the countries that export to the U.S. market.

That’s a huge, complicated objective that could potentially involve numerous audit entities in multiple regions, so we’ve got to work with the FDA and industry partners to help ensure that the audit process is as efficient as possible.

Just as we’ve done with the FDA’s earlier rule proposals on produce safety and preventive controls, United Fresh is conducting a deliberative education and review process for the draft rules on imported foods and third-party auditor accreditation.

In the near future, United plans to host Web seminars on each of the proposed rules with FDA.

You’ll have a chance to go to the FDA offices and talk face to face with FDA staff during United’s Washington Public Policy Conference, Sept. 30 to Oct. 2.

Now that we finally have four proposed rules to consider, it will be an excellent opportunity to hear what FDA has been hearing about all four proposed rules and to share your comments with FDA.

David Gombas is senior vice president for food safety and technology for the Washington, D.C.-based United Fresh Produce Association.

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