The FDA has established standards related to produce in an effort to reduce the impact of foodborne illnesses among consumers. These standards to not apply to produce that is usually not consumed raw, grown for personal consumption, or not a raw agricultural product. Additionally, produce that goes through commercial processing techniques that adequately reduce contamination is eligible for exemption. The Final rule will publish in the Federal Register on November 27, 2015. The FDA has also issued a final environmental impact statement that will publish along with the rule.
These standards, implemented under the Food Safety Modernization Act (FSMA) (P.L. 111-353), are intended to address the situations in which produce can be contaminated with microorganisms of public health significance during growing, harvesting, packing, or holding. The FDA has made changes after considering public comments following the Proposed rule in January 2013 and the supplemental notice of proposed rulemaking issues in September 2014.
The rule establishes criteria for microbial water quality. No detectable generic E. coli are allowed when it is reasonably likely that dangerous microbes would be transferred to the produce. This includes water used: for washing hands, for rinsing food-contact surfaces, in direct contact with produce (including water used to make ice), and for sprout irrigation. If generic E. coli is detected, the water use must be discontinued and corrective actions implemented. For water that is applied directly to growing produce, the FDA has established geometric mean (GM) and statistical threshold values (STV) for the permissible amount of E. coli. The rule also establishes standards for testing untreated water.
At this time, the FDA considers adherence to the U.S. Department of Agriculture’s (USDA)’s National Organic Program standards for the application of raw manure as a soil amendment to be appropriate in minimizing the likelihood of contamination. The standards call for a 120-day interval between the application of this amendment and harvesting for crops in contact with soil, with a 90-day interval for crops not in contact. The agency is conducting extensive research on the risk of contamination and the number of days needed between application and harvesting.
Sprouts are particularly vulnerable to microbes and have been associated with outbreaks of bacteria. The rule contains standards specific to sprouts, such as preventing the transfer of microbes onto seeds used for sprouting and testing spent irrigation water for pathogens. The time frame for enforcing the standards for sprout operations will be shorter than for the other provisions of the rule.
Workers who are ill or infected must inform their supervisors of any health condition that may result in contamination. Visitors and workers must take measures to prevent contamination of produce and food-contact surfaces. Farm workers must be trained on health and hygiene. The rule includes standards related to sanitation of equipment, tools, and buildings. Farms that rely on grazing or working animals are required to identify and refrain from harvesting produce that is likely to be contaminated by these animals, similar to standards in place for intrusion by wild animals.
The FDA identified four standards in the rule that could potentially significantly impact the human environment. The FDA considered implementing different GM and STV for water applied to growing produce. It also considered a range of standards for the application intervals for untreated and treated biological soil amendments as well as how farms would respond to domesticated and wild animals and alternatives to the general provision establishing which farms would be covered under the rule.