The Produce Safety Rule “establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption.” – The Food and Drug Administration

The 2011 Food Safety Modernization Act (FSMA) is considered to be “the most sweeping reform of our food safety laws in more than 70 years,” according to the Food and Drug Administration.

produceThe motivation behind the broad legislation was two-fold: to increase public concern over the nation’s food supply and—at the time—proliferous outbreaks, and to address demands from stakeholders to supplement responsive food safety processes with preventative mechanisms.

The Produce Safety Rule is one of seven major rules under the FSMA that is currently being implemented by the government. The rule is designed to establish minimum scientific safety standards for the growing, holding, harvesting, and packing of produce. The statute includes imported produce, in addition to U.S. domestic fruit and vegetable supply.

The rule includes the majority of sellers, growers, packers and processes—all of whom have a two- to four-year compliance deadline. The deadline is determined by the scale of business operations. Qualified exemptions include operations that, for the previous three years, have earned $25,000 or less from produce sales.

Provisions of the Rule

Among the more important requirements of the rule are the new water quality standards and water testing procedures. For example, certain water samples taken must not contain any detectable E. coli bacteria, including “water used for washing hands during and after harvest, water used on food-contact surfaces, water used to directly contact produce (including to make ice) during or after harvest, and water used for sprout irrigation.”

The law requires that untreated surface water be tested more frequently. The rationale for the change is that surface water is particularly vulnerable to environmental conditions and other external influences. In order to calculate the “microbial water quality profile,” water samples are tested using two values: geometric mean (GM) and statistical threshold (STV). GM is used to determine the “tendency” of water quality. STV is used as a numerical representation of the amount of water variability (e.g. E. coli levels after a certain adverse event, such as heavy rainfall).

produceIn addition, the application of raw manure as a soil additive is currently undergoing a “risk assessment” and research on the appropriate number of days between initial application and harvesting. The FDA is calling for compliance with United States Department of Agriculture (USDA) guidelines, which require a minimum amount of time—between 90 to 120 days—before crops can be harvested after raw manure is applied.

Limit standards have been set on detectable amounts of bacteria in manure product, as well. Manure samples are used to test for bacteria such as Listeria monocytogenes, Salmonella, E. Coli (O157:H7 strain), and fecal coliforms. Composting standards considered scientifically valid are recommended by the FDA, as proper application of these standards “minimizes the potential for contact with produce during and after application.”

Moreover, new regulations are in effect that are meant to prevent the contamination of sprouts. Statistically, contaminated sprouts are one of the leading causes of foodborne illness outbreaks, including cases of severe food poisoning. Statistics published on the FDA website note the following data between 1996 and 2014: 43 outbreaks, 2,405 illnesses, 171 hospitalizations, and three deaths.

Suppliers are required to implement an actionable plan to prevent the origination of microbes “into or onto seeds…used for sprouting, in addition to treating seeds or beans that will be used for sprouting.” Water testing is now a requirement for each production cycle of sprouts. Tests that are taken during each production cycle must demonstrate a negative result for certain types of pathogens. Additional testing is required to ascertain the absence of Listeria monocytogenes and other Listeria species in areas used for “growing, harvesting, packing, and holding” of produce. Compliance with statutes that govern the harvesting of sprouts is shorter than that for other products, with a limit of one to three years.

The final rule drafted involves compliance with statutes for farms that “rely on grazing animals (such as livestock) or working animals for various purposes.” Farmers are required to manage areas where livestock are grazed to ensure that produce is not harvested in areas where contamination is possible.

In some instances, farmers must perform additional assessments during the growing season in order to ensure that compliance is maintained. Should evidence surface that demonstrates potential contamination, measures must be taken to identify any affected area. Specifics involving assessment requirements are currently being evaluated by the FDA. During this interval, farmers and other producers are provided with supplementary material to ensure safe harvesting procedures when livestock are involved.

Other points outlined in the Produce Safety Rule of the FSMA include: worker training; health and hygiene; and sanitary practices involving equipment, tools, and buildings.

Currently, the FDA is working with producers and associated organizations, including the United Fresh Produce Association and the Produce Marketing Association, to assist with education and compliance efforts.