FDA publishes Final Rule on Produce Safety

The rule covers agricultural water, biological soil amendments, sprouts, worker training, hygiene, equipment and more.


From FDA

The FDA Food Safety Modernization Act (FSMA) Produce Safety rule is now final. The 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.

Growers are encouraged to read the full text of the rules, visit the FDA's page at this link: http://goo.gl/4DpCCi

The rule has six key requirements, which are briefly covered below (more highlights are available at FDA's website): 

1. Agricultural Water

  • Water quality: The final rule adopts the general approach to water quality proposed in the supplemental rule, with some changes. The final rule establishes two sets of criteria for microbial water quality, both of which are based on the presence of generic E. coli, which can indicate the presence of fecal contamination.

2. Biological Soil Amendments

  • Raw Manure: The FDA is conducting a risk assessment and extensive research on the number of days needed between the applications of raw manure as a soil amendment and harvesting to minimize the risk of contamination. (A soil amendment is a material, including manure, that is intentionally added to the soil to improve its chemical or physical condition for growing plants or to improve its capacity to hold water.)
  • Stabilized Compost: Microbial standards that set limits on detectable amounts of bacteria (including Listeria monocytogenes, Salmonella spp., fecal coliforms, and E. coli 0157:H7) have been established for processes used to treat biological soil amendments, including manure. The rule includes two examples of scientifically valid composting methods that meet those standards. Stabilized compost prepared using either of these methods must be applied in a manner that minimizes the potential for contact with produce during and after application.

3. Sprouts 

  • The final rule includes new requirements to help prevent the contamination of sprouts, which have been frequently associated with foodborne illness outbreaks. Sprouts are especially vulnerable to dangerous microbes because of the warm, moist and nutrient-rich conditions needed to grow them.
  • Sprout operations will have less time to come into compliance with the rule than farms growing other produce. They will have one to three years to comply based on the size of their operation, with no additional time to meet the water requirements.

4. Domesticated and Wild Animals

  • The rule addresses concerns about the feasibility of compliance for farms that rely on grazing animals (such as livestock) or working animals for various purposes. It establishes the same standards for these animals as it does for intrusion by wild animals (such as deer or feral swine). Farmers are required to take all measures reasonably necessary to identify and not harvest produce that is likely to be contaminated. 

5. Worker Training and Health and Hygiene

  • Farm workers who handle covered produce and/or food-contact surfaces, and their supervisors, must be trained on certain topics, including the importance of health and hygiene.
  • Farm workers who handle covered produce and/or food contact surfaces, and their supervisors, are also required to have a combination of training, education and experience necessary to perform their assigned responsibilities. This could include training (such as training provided on the job), in combination with education, or experience (e.g., work experience related to current assigned duties).

6. Equipment, Tools and Buildings

  • The rule establishes standards related to equipment, tools and buildings to prevent these sources, and inadequate sanitation, from contaminating produce. This section of the rule covers, for example, greenhouses, germination chambers, and other such structures, as well as toilet and hand-washing facilities.
    o Required measures to prevent contamination of covered produce and food contact surfaces include, for example, appropriate storage, maintenance and cleaning of equipment and tools.
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