FDA, USDA Plan to Streamline Produce Safety Rules For Farmers

Two federal agencies have agreed to work jointly in order to better coordinate produce safety rules for farmers. 

The U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) announced an agreement on June 5, which they say will streamline produce safety requirements, including the alignment of the USDA Harmonized Good Agricultural Practices Audit Program (H-GAP) and the FDA’s Food Safety Modernization Act (FSMA) Produce Safety Rule.

According to the announcement, aligning the two rules will allow farmers to use the H-GAP rule to assess their food safety practices to gauge whether they are prepared to meet the Produce Safety Rule requirements.

FDA Commissioner Scott Gottlieb indicated that FDA and USDA staff are working together to develop auditor and user manuals that will align the two rules, to reduce duplicitous burdens on farmers.

“For the purposes of this activity, ‘alignment’ means that — while the two programs are not identical — the relevant technical components in the FSMA Produce Rule are (1) covered in the USDA AMS H-GAPs Program; and (2) the market access audit requirements utilized in the USDA AMS H-GAPs Program are aligned with the food safety goals of the FSMA Produce Rule,” Gottlieb wrote in a June 5 letter to USDA Secretary Sonny Perdue.

Gottlieb noted that while meeting the H-GAP requirements will be a guide for farmers, that will not be a substitute for FDA or state regulatory inspections.

The effort comes amid concerns over produce safety, highlighted by a recent E. Coli food poisoning outbreak linked to romaine lettuce, which has killed at least five people.

In addition, the outbreak has sickened at least 197 people in 35 states; 89 of which required hospitalization, according to the latest report from the U.S. Centers for Disease Control and Prevention (CDC). At least 26 people have developed hemolytic uremic syndrome (HUS), a serious type of kidney failure linked to food poisoning.

The illnesses have been tracked back to romaine lettuce grown in the Yuma, Arizona and CDC investigators warn that some may still be in stores, restaurants and people’s homes.

The CDC estimates that roughly 48 million Americans are sickened by foodborne illnesses each year, causing around 130,000 hospitalizations and 3,000 deaths. Foodborne illnesses, E. coli especially are easily transmitted by consuming, touching, drinking, or by some sort of physical transfer of the bacteria.