Food Safety Modernization Act Produce Safety Rule

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.

Key elements of the new rule include:

Subpart C and D: Personnel qualifications and training, worker health and hygiene:

Farm workers (including supervisors) who handle covered produce and/or food contact surfaces must be trained on the importance of health and hygiene. Farms must take steps to prevent contamination of produce and food-contact surfaces by people who are sick. This includes instructing farm workers to notify their supervisors if there’s an issue with their health or hygiene that could compromise the safety of the produce.

Subpart E: Agricultural water, for production and post-harvest uses:

Requirements for agricultural water quality and testing are designed to detect contamination by feces, which may be accompanied by bacteria that cause disease.

The U.S. Food and Drug Administration is proposing to amend the agricultural water provisions of the produce safety regulation that covered farms have found complex and challenging to implement. This proposal would replace the microbial criteria and testing requirements for pre-harvest agricultural water for covered produce (other than sprouts). Under the proposed requirements, covered farms would be required to conduct pre-harvest agricultural water assessments once annually, and whenever a change occurs that increases the likelihood that a known or reasonably foreseeable hazard will be introduced into or onto produce or food contact surfaces. As part of their pre-harvest agricultural water assessments, these farms would be required to evaluate certain factors that could impact produce safety. The new provisions for systems-based agricultural water assessments are designed to be more feasible to implement across the wide variety of agricultural water systems, uses, and practices, while also being adaptable to future advancements in agricultural water quality science and achieving improved public health protection. These proposed revisions to the produce safety regulation, if finalized, would more comprehensively address a known route of microbial contamination that can lead to preventable foodborne illness that is a significant public health problem.

Resources:

• FSMA Proposed Rule on Agricultural Water
• Agricultural Water Assessment Fact Sheet
• Interactive Agricultural Water Assessment Builder
• Factors to Consider as Part of Agricultural Water Assessment
• Paper-based versions of the agricultural water assessment builder tool:
  • Agricultural Water Assessment Builder (English)
  • Constructor de Evaluación de Agua de Uso Agricola (Spanish)

Questions regarding the proposed rule may be directed to Kris Gasperic at the Indiana Department of Health by calling 317-233-8475. We will continue to communicate updates as they become available.

Subpart F: Biological soil amendments:

There are requirements for the use of biological soil amendments of animal origin, including manure and compost, which are added to soil to improve its ability to support plant growth. Meeting these requirements will help reduce the likelihood of potentially dangerous bacteria entering the food supply.

Subpart I: Domesticated and wild animals:

There are often animals on farms, such as livestock, and even wild animals, like deer. During harvest, farmers are required to take all reasonably necessary steps to identify potential contamination (including contamination by animals) and not harvest the affected produce. In some circumstances, farmers must also take steps to assess potential contamination by animals during the growing season, in anticipation of these requirements at harvest.

Subpart K: Growing, Harvesting, Packing and Holding Activities:

Farmers must be able to recognize contaminated produce in the field and know when not to harvest.  They are also required to separate covered produce from excluded produce, and handle covered produce in a manner that protects it from contamination. Packaging and food packing materials should also be considered during packing and holding activities.

Subpart L: Equipment, tools, buildings and sanitation:

Finally, there are standards related to equipment, tools and buildings to prevent problems, such as poor sanitation, from contaminating produce. Buildings covered by these requirements include greenhouses and germination chambers.

Subpart M: Sprout production:

Sprouts have been associated frequently with foodborne illness outbreaks. The final rule includes testing and other standards for producing sprouts to prevent contamination with dangerous microbes, such as Listeria monocytogenes.

Subpart O: Records, retention and accessibility:

Records that are required in other subparts must be complete, legible and kept for at least 2 years after the date the record was created.  They may be stored offsite if they can be retrieved and available onsite within 24 hours of request.  Records are required to document personnel training, water test results, water system inspection, cleaning/sanitizing of equipment and tools, and treatment of biological soil amendments of animal origin.  Records must also be kept to establish eligibility for a qualified exemption.

Subpart Q: Compliance and enforcement:

This subpart outlines provisions for education and enforcement of the Produce Safety Rule when produce is considered adulterated.

Subpart R: Withdrawal of qualified exemption:

IDOH may withdraw a farm’s qualified exemption in the event of an active investigation of a foodborne illness outbreak that is directly linked to your farm, or if IDOH determines that it is necessary in order to protect public health and prevent or mitigate a foodborne illness outbreak based on the conduct or conditions of the farm.