FDA hasn't provided guidance for 11 years so now there are too many "standards"

A side-by-side analysis of a variety of produce standards shows significant variations in guidance given to fruit and vegetable growers regarding what steps to take to minimize microbial contamination in light of federal rules, says a report from the Produce Safety Project (PSP), an initiative of The Pew Charitable Trusts at Georgetown University.

Since FDA issued its voluntary produce safety guidance 11 years ago, a number of organizations have stepped into the regulatory void and adopted their own standards for the growth and harvest of fresh produce. Some standards are general in nature, and others are commodity specific, says the report.

The PSP analyzed six standards, including FDA’s 1998 Good Agricultural Practices (GAP) guidance document. The analysis revealed this guidance lacks many of the criteria found in newer standards. FDA announced late last year that it intends to update its GAP guidance, but it will remain voluntary, and no timetable for the update was announced.

“The failure of the past Administration to let FDA move toward mandatory and enforceable standards for produce has clearly created a void that others are trying to fill,” said Jim O’Hara, PSP director. “But FDA leadership is needed to determine sound science and make certain there is a level playing field,” he added.

In 1997, the Clinton Administration’s “Food Safety Initiative” identified the safety of fresh produce as a priority, and FDA followed up in 1998 with its guidance to minimize microbial contamination during the growing, harvesting and packing of fresh fruit and vegetables. In the wake of the 2007 E. coli outbreak associated with bagged spinach, FDA unsuccessfully sought permission from the Bush administration to develop mandatory produce safety standards.

The PSP analysis found the following criteria missing in the 1998 FDA guidance, but addressed in the other standards:

  • Microbial standards and sampling test protocols for irrigation water;
  • Consideration of prior use of growing land;
  • Microbial standards and sampling and testing protocol for manure;
  • Distance from concentrated animal feeding operations (CAFOs).

Differences among the standards discovered by PSP included the following:  

  • Three of the guides prohibit growing produce on flooded land without first taking steps to minimize contamination;
  • While all of the guides require sanitizing of equipment and tools, only one requires verification of the procures used;
  • Distances for toilets for field workers varies from general to specific;
  • Animal-control provisions vary, and one standard fails to address the issue at all.

The guidelines reviewed by PSP include the following:

  1. Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables issued by FDA in 1998.
  2. Code of Hygienic Practice for Fresh Fruits and Vegetables: adopted in 2003 by the Codex Alimentarius Commission, a body established by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO).
  3. Food Safety Leadership Council On-Farm Produce Standards, finalized in 2007 by a group of large retailers/buyers.
  4. GLOBALGAP, a series of integrated standards, developed in 2007 and used by growers around the world.
  5. Commodity Specific Food Safety Guidelines for the Production and Harvest of Lettuce and Leafy Greens, initially issued in 2007 and followed by the growers who signed the California Leafy Green Products Handler Marketing Agreement.
  6. Commodity Specific Food Safety Guidelines for the Fresh Tomato Supply Chain (Edition 1.0) and the Tomato Best Practices Manual. These two documents were incorporated into the Florida Tomato Rule, which implements legislation passed in the State of Florida in 2008.
More information can be found at PSP’s Web site: www.producesafetyproject.org.