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FDA Produce Inspections

Food Safety Modernization Act / Regulation / Food Safety

The Produce Safety Rule: Preparing for Routine FDA Inspections


We all know that 2018 was not a great year for farmers and growers in the United States. From romaine lettuce to pre-cut melons, we witnessed several foodborne disease outbreaks linked to the produce industry, triggering huge nationwide recalls. At least 800 people were sickened or hospitalized from multiple E. coli  outbreaks linked to romaine lettuce alone.

For farmers and regulators, reducing the number of food safety incidents remains a priority. If you operate a business that grows and sells fresh produce (fruits and vegetables), you should ensure your business complies with the provisions of the  Produce Safety rule for which FDA inspections start in Spring 2019.

The Produce Safety rule is part of the Food Safety Modernization Act and also affects those who pack or hold fresh produce. In the words of the FDA, the Produce Safety rule, “establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption.”

The rule outlines key safety requirements in the following six major areas:

  • Agricultural water - includes water quality and testing standards, in particular, to detect possible contamination with fecal matter.

  • Biological soil amendments - includes standards and requirements for raw manure and stabilized compost used in the growing of produce.

  • Sprouts - includes standard treatments for sprouts and specifies testing requirements to prevent contamination with dangerous microbes, especially Listeria monocytogenes.

  • Domesticated and wild animals - includes standards to prevent potential contamination of produce by contact with farm animals and requirements for contaminated produce.

  • Worker training and health and hygiene - includes safety and produce-handling best practices for farm workers and supervisors

  • Equipment, tools and buildings - includes sanitary practices and requirements for equipment, holding and packing spaces.

Compliance and FDA inspection dates

Major compliance dates for businesses subject to the Produce Safety rule arrived on January 26, 2018 and January 28, 2019 for large and small farms, respectively. The size classification is based on the volume of annual sales. Large farms sell an average of more than $500,000 a year in produce. Small farms have sold an average of more than $250,000 but not more than $500,000 a year in produce over the past three years, on a rolling basis.

Inspections for large farms are scheduled to start in Spring 2019, while those for small farms will start in Spring 2020. If your business is covered by the rule, now is the time to be proactive and prepare for potential inspections.

Not all the rules may apply

Understanding the rules which apply to your business is the first step towards a successful inspection. While some businesses may be exempt from all the rules, one or several parts of the rule may be applicable to other businesses. To ensure adequate training and education, the FDA has provided resources for farmers and stakeholders in the produce industry ahead of inspections.

  • The produce safety page links to all resources relevant to the FSMA final rule on produce safety. These will help you identify the rules that apply to your business.

  • The produce safety inspections page features all resources relevant to inspections. This will help you prepare for the actual inspections.

  • The draft guidance provides recommendations for subparts of the produce safety rule.

Preparing for a successful inspection

Complying with regulations (old and new) is difficult without a robust safety and traceability system. The Produce Safety rule specifies several compulsory records that you must keep and maintain, including documentation for treatment of seeds or beans for sprouting, water testing and worker training. FoodLogiQ’s software solutions make it easier to meet FSMA requirements and be regulatory compliant.  With FoodLogiQ’s Manage + Monitor, you can manage key documents and food safety plans in the cloud, streamlining your supplier documentation.

To learn how FoodLogiQ solutions can ease your regulatory compliance, request a demo.

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Posted by Katy Jones on Mar 15, 2019 9:23:48 AM

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