On November 13, 2015, the US Food and Drug Administration (FDA) issued a final rule addressing the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, a rule first proposed by the FDA in January 2013. The final rule aims to minimize the risk of adverse health consequences from consumption of contaminated produce and focuses on biological hazards in the following routes of contamination: (1) Agricultural Water; (2) Biological Soil Amendments; (3) Domesticated and Wild Animals; (4) Sprouts; (5) Worker Training and Health and Hygiene; and (6) Equipment, Tools, and Buildings.
The final rule does not apply to produce that is not a raw agricultural commodity or that the FDA has identified as rarely consumed raw (e.g., asparagus, peanuts, coffee beans, eggplant). Food grains, produce used for personal consumption, and commercially processed produce that adequately reduces the presence of pathogens are also exempt.
The final rule provides for certain qualified exemptions and modified requirements where (1) the farm has food sales averaging less than $500,000 per year during the previous three years and (2) the farm’s sales to a qualified end-user (i.e., a consumer, restaurant, or retail food establishment located in the same state or not more than 275 miles away) exceed sales to all others combined during the previous three years.
The final rule establishes two microbial water quality criteria, both of which are intended to address the potential for fecal contamination and use E. coli as an indicator.
- The microbial water quality criterion of zero detectable generic E. coli applies where there is a foreseeable risk of fecal contamination that could be transferred directly to covered produce (e.g., water on food-contact surfaces or water used for hand washing during and after harvest). The final rule establishes that such contaminated water be immediately discontinued and corrective action taken. When implementing corrective action, covered farms have some flexibility. For example, a covered farm may choose to re-inspect its entire affected agricultural water system, treat the water, or use the water for another permitted purpose.
- The microbial water quality criterion of specified geometric mean (GM) and statistical threshold (STV) values covers agricultural water directly applied to covered produce (other than sprouts) during growing activities. The FDA envisions that covered farms will use the two criteria as waste management tools to assist covered farms in developing a long-term strategy for tracking the safety and quality of their agricultural water over time. Where agricultural water does not meet the specified criteria, corrective action is required no later than the following year. Covered farms may continue to use agricultural water that does not initially satisfy these criteria while implementing corrective action. For example, covered farms may allow time for potentially dangerous microbes to die off using time intervals (either between last irrigation and harvest or harvest and end of storage) or appropriately treat the water.
Biological Soil Amendments
The final rule requires that a biological soil amendment of animal origin be handled, conveyed, and stored in a manner and location to ensure that it does not become a potential source of contamination to covered produce, food-contact surfaces, areas used for covered activities, water sources, and water distribution systems. The final rule expands the acceptable processes for treatment of biological soil amendments, permitting processes other than composting so long as these processes meet the microbial standards explicitly outlined in the final rule.
The final rule further prohibits the use of human waste for growing covered produce, with a limited exception for sewage sludge biosolids used in accordance with certain regulatory requirements.
Domesticated and Wild Animals
The final rule eliminates the proposed requirement for an adequate waiting period between grazing and harvesting. However, the FDA encourages covered farms to voluntarily implement a waiting period between grazing and harvesting, in particular where there is a reasonable probability that grazing animals will contaminate covered produce.
The FDA acknowledges the longstanding practice of cultivating covered produce and grazing animals on the same soil. The final rule adds new language clarifying that covered farms are not required to take measures to exclude animals from growing areas or otherwise destroy animal habitats. During the growing season (prior to harvest), and under only those circumstances where there is a reasonable probability that grazing animals, working animals, and animal intrusion may contaminate covered produce, covered farms must visually assess all relevant areas used for covered activity. Where evidence of potential contamination is found (e.g., significant quantities of animals, amounts of animal excreta, or crop destruction), the covered farm must evaluate whether the covered produce can be harvested.
Because sprouts have been frequently associated with foodborne illness outbreaks, the final rule establishes standards specific to sprouts. The final rule outlines requirements applicable to seeds and beans used to grow sprouts and further requires testing both spent sprout irrigation water and the growing, harvesting, packing, and holding environment for Listeria and L. monocytogenes, both of which commonly contaminate sprouts. The final rule implements an additional layer of protection, prohibiting batches of sprouts from entering commerce unless the results of testing of spent sprout irrigation water or sprouts is negative for certain pathogens.
In addition to the testing requirements, sprout farms establish and implement written environmental monitoring and corrective action plans. The FDA envisions that these plans will enable sprout farms to consider likely contamination scenarios in advance, thus ensuring a more streamlined response.
Worker Training and Health and Hygiene
The FDA acknowledges the critical role that agricultural workers play in farming operations, but also recognizes that bacteria, viruses, and parasites are frequently transmitted from person to food. All personnel who contact covered produce and food-contact surfaces receive training when hired, before participating in the growing, harvesting, packing, or holding of covered produce (or at least once annually), and on a periodic basis for refresher training. The final rule provides flexibility for how personnel are qualified to perform their assigned duties (i.e., through a combination of education, on-the-job training, or work experience).
The final rule requires that covered farms instruct their personnel to notify supervisors if they have (or believe they might have) certain specified health conditions. The FDA expects covered farms will remove infected employees from operations that may result in contamination of covered produce or food-contact surfaces. The final rule mandates other hygienic practices, such as thorough hand washing; removing or covering hand jewelry; and not eating, chewing gum, or using tobacco products in areas devoted to covered activities.
Visitors must also be made aware of the covered farm’s policies and procedures for personal hygiene and the potential for contamination from ill or infected visitors. Covered farms have flexibility in choosing whether to post visitor rules or choose to voluntarily establish a policy that visibly ill visitors may not enter specific areas of the farm.
Equipment, Tools, and Buildings
The final rule outlines the accepted practices for storing and maintaining equipment tools to protect against contamination from pests, which can carry human pathogens. The FDA enables substantial flexibility in this area, permitting covered farms to store equipment either indoors or outdoors, provided the equipment is routinely checked for pests. Covered farms must also inspect, maintain, and clean all food-contact surfaces of equipment and tools used in covered activities. Sanitation is required only when necessary and appropriate.
Buildings must allow sufficient space for storing equipment and materials, although the FDA does not specify the precise amount of space needed for storage. Covered farms must also implement measures to prevent contamination in the farm’s buildings, considering the potential for contamination both through floors, walls, ceilings, fixtures, ducts, or pipes and through drip or condensate.
The final rule establishes for the first time scientifically based standards for ensuring safe produce grown for human consumption. To ensure compliance with this final rule, companies will encounter additional overhead costs associated with implementing proper oversight, testing, and training. As the agency left much of the proposed rule intact, hopefully companies have already begun to implement the requirements. For those who haven’t already begun implementation, compliance dates for some covered farms begin as early as one year following the effective date of this final rule. The final rule is scheduled to be published in the Federal Register on November 27, 2015, and will become effective 60 days following its publishing.
*Blake Walsh is admitted only in Tennessee. Her practice is supervised by principals of the firm admitted in the District of Columbia.