Dueling Produce Safety Standards Highlight Void Left by Lack of FDA Regulation

Contact: James Moore, 703.739.2424 x106


Washington, DC - 05/07/2009 - A side-by-side analysis of a variety of produce safety standards shows significant variations in guidance given fruit and vegetable growers in what steps they need to take to minimize microbial contamination in light of the lack of federal rules.

Since the U.S. Food and Drug Administration (FDA) issued its voluntary produce safety guidance 11 years ago, a number of organizations and one state have stepped into the regulatory void and adopted their own standards for the growing and harvesting of fresh produce (fruits and vegetables intended to be consumed raw). Some standards are general in nature, and others are commodity specific.

The Produce Safety Project, an initiative of The Pew Charitable Trusts at Georgetown University, analyzed six standards, including FDA’s 1998 Good Agricultural Practices (GAP) guidance document. The analysis shows that FDA’s guidance lacks many of the criteria found in newer standards.  FDA announced late last year that it intends to update its GAPs guidance document, but it will remain voluntary and no timetable for the update has been announced.

“The failure of the past Administration to let FDA move toward a 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. This is why it’s critical for Dr. Peggy Hamburg to be confirmed as FDA commissioner and be on the job as soon as possible.”

In 1997, the Clinton Administration’s “Food Safety Initiative” identified the safety of fresh produce as a priority, and the FDA followed up in 1998 with its guidance to industry on ways to minimize microbial contamination during the growing, harvesting and packing of fresh fruits and vegetables.

In 2007, in the wake of the outbreak of E. coli O157:H7 associated with bagged spinach, the FDA unsuccessfully sought permission from the Bush administration to develop mandatory produce-safety standards.

“It’s not a surprise that virtually every piece of food safety legislation introduced in the last Congress and re-introduced in this Congress calls on FDA to do its job on produce safety,” said Sandra Eskin, PSP deputy director, who produced the side-by-side analysis. “Both consumers and industry want the public health protection of science-based standards that can minimize the risk of foodborne illness from foods that are a vitally important part of a healthy diet.”

Among the criteria missing in the 1998 FDA guidance but addressed in the others:

  • Microbial standards and sampling and testing 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)
Among the differences between standards:

  • 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 procedures used.
  • Distance 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 are:

  • Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables: issued by FDA in 1998
  • 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)
  • Food Safety Leadership Council On-Farm Produce Standards, finalized in 2007 by a group of large retailers/buyers.
  • GLOBALGAP – a series of integrated standards, developed in 2007 and used by growers around the world.
  • 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.
  • 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.
Pew is no longer active in this line of work, but for more information visit the Produce Safety Project's Web site, or visit the Produce Safety Project on PewHealth.org.

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