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FDA’s Draft Guidance: How to Comply with the FSMA Produce Safety Rule

April 11, 2019


radishes being washed MI credit lindsey scalera
FDA’s Draft Guidance provides insight into the Produce Safety Rule, but some questions still remain. Photo Credit: Lindsey Scalera

The Food Safety Modernization Act’s Produce Safety Rule is complex. There are still questions about how it will be enforced for the first time and the required actions and tools farms need to comply. Some of these questions might be answered by the U.S. Food and Drug Administration’s (FDA) Draft Guidance on the Produce Safety Rule, a look at FDA’s current thinking on how the rule will be enforced, but some questions still remain unanswered.

It’s important to note that the document is only draft guidance. This means that FDA is likely to change what is in the document after considering the public’s input. Final Guidance or a new Draft Guidance document may answer additional questions. With that in mind, it is critical to let FDA know what outstanding questions you might have by submitting a comment on the Draft Guidance. You should also let FDA know how this Guidance applies to your operation or the farm operations your organization works with around food safety compliance.

The Draft Guidance is available here.

This post provides an overview of the Draft Guidance, including information about what areas to consider commenting on before the comment period closes on April 22, 2019.  The National Sustainable Agriculture Coalition (NSAC) also encourages reviewing the guidance to determine what information might be helpful for you, specifically, or the operations you are working with around Produce Safety Rule compliance.

Overview of What’s In and What’s Out

The Draft Guidance provides information and examples about most provisions of the Produce Safety Rule. Chapter one discusses how farms can determine whether or not they are required to comply with the Produce Safety Rule. Chapters two and three describe worker training, health and hygiene, and provide several ideas about what topics farms might want to cover during worker trainings on food safety. FDA’s current thinking on applying Biological Soil Amendments of Animal Origin (BSAAOs), which include compost with animal manure or byproducts and animal manure applied to the soil, monitoring for animal contamination, reducing contamination at the growing, harvest, packing and holding stages, ensuring clean tools, equipment, and buildings, and keeping all required records are in chapters four, five, six, seven, and eight, respectively.

NSAC is disappointed the Draft Guidance failed to provide additional information about Subpart R –Withdrawal of Qualified Exemption and Subpart Q – Compliance and Enforcement. While FDA recently released a three page handout for farmers about inspections, three pages cannot sufficiently answer farmers’ questions about inspections. We posed several unanswered inspection related questions in our post on The FSMA Produce Safety Rule: An Inspection Preview.

FDA’s “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need to Know About the FDA Regulation: Guidance for Industry Small Entity Compliance Guide” (“Small Entity Guide”) does provide some information about withdrawing a qualified exempt status, but it fails to describe what actions or food safety risks might cause FDA to withdraw a farm’s qualified exempt status. There is also no guidance on Subpart E – Agricultural Water because FDA has postponed the requirements of this subpart while they consider revisions to the rule. At this time, farms are not required to comply with the requirements within Subpart E until January 26, 2022 for large farms, January 26, 2023 for small farms, and January 26, 2024 for very small farms.

Key Takeaways

As you read through the Draft Guidance, it is important to understand  that “should” simply means “recommended, but not required” throughout the Draft Guidance document. If the Draft Guidance states, for example, that farms should include several topics in their worker training, this does not mean farms are required to include every single item in that list in their worker training. Instead, farms should consider what subjects should be included that are relevant for their workers and farm.

There are details in the guidance that provide clarity for farms about how to comply with the Produce Safety Rule. For example, with regard to record keeping, FDA states that any treated BSAAOs from a third party only require an annual documentation, such as a Certificate of Conformance.

FDA also describes how often growers should monitor for animal contamination by stating that if wild animal occurrence is noticed weekly, then it’s expected that the grower monitor for those animals weekly; and if animal occurrence is seasonal, then there should be monitoring for those animals when they generally show up seasonally.

NSAC appreciates FDA providing details, including those described above, in the Draft Guidance that help all stakeholders, including farmers, educators, and inspectors, understand the steps farms should take to comply with the Produce Safety Rule.

However, the Draft Guidance still lacks sufficient information on several key topics. For example, FDA provides no guidance on whether or not fruit sets are covered by the Produce Safety Rule based on when they are deemed “harvestable.” FDA also fails to provide additional guidance on how wax boxes can be reusable and still in compliance with the Produce Safety Rule. We hope FDA will continue to release educational materials that provide clarity for farmers on a number of Produce Safety Rule related compliance questions, and we look forward to working with FDA to provide additional clarity for farmers.

Submit a Comment to FDA

After speaking with stakeholders, NSAC identified several items that should be included, and others that should be changed, before the Final Guidance document on the Produce Safety Rule is released.

A draft comment template is available here to assist anyone interested in writing a comment on the Draft Guidance document.

Overall, if you see an item in the Guidance that you like, ask FDA to keep it in the Guidance. If you see a section of the Guidance that is concerning, tell FDA what they should change and where additional information would be helpful. Do you feel like your farm is not included in the Draft Guidance? Tell FDA how a situation might apply to your farm. What additional information would be helpful for your operation or the operations you work with?

Submit your comment here by copying and pasting or writing text directly in the comment box, or by uploading a file that includes your comment.

All comments are due by Monday, April 22, 2019 at midnight.

Specifically, NSAC’s comment template requests that commenters:

  • Ask FDA to change:
    • FDA should change their position on vermicomposting. Vermicomposting should be considered a proper treatment process under Subpart F of the Produce Safety Rule, which regulates the use of BSAAOs on produce farms covered by the rule. If FDA does not change their position, farms may not be able to realistically use vermicomposting to increase soil biodiversity and fertility where produce subject to the rule is grown.
  • Ask FDA to add:
    • FDA should draft new Guidance on Subpart Q, Compliance and Enforcement. The jurisdiction of who is and is not conducting inspections and enforcing the Produce Safety Rule in each state is complicated. NSAC discussed in a previous post several items around Produce Safety Rule on-farm inspections where stakeholders still remain in the dark. FDA should include Guidance on Produce Safety Rule inspections, so producers have a better understanding of what to expect when an inspector calls and shows up at their farm.  
    • The Draft Guidance should also include information for diversified farms with crop and livestock rotations. There are no clear examples or language in the Draft Guidance for farms about using a crop/ livestock rotation and how the co-location of grazing animals and produce will be evaluated under the Produce Safety Rule
    • Also, the Draft Guidance does not include examples specific to certified organic operations. Additional Guidance should be provided for farms expected to comply with both the National Organic Program standards and the Produce Safety Rule.
  • Ask FDA to keep:
    • FDA should keep all practical examples, including the language that allows farmers to estimate their annual sales if they do not yet have three years of sales records to prove an exemption or qualified exemption. Allowing projections of farms’ three years of annual sales to determine an exemption is both reasonable and realistic for beginning farmers.
    • FDA should also keep in the Draft Guidance language that affirms farms can continue to use porous materials such as wood, fabric, or foam if maintained and sanitized to prevent food safety risks.

What FDA wants to hear from you!

FDA is also requesting specific comments on several topics related to the Produce Safety Rule, including the following:

  • For equipment and tools intended to or likely to contact covered produce:
    • When acquiring equipment and tools, how do you engage with equipment and tool suppliers about the size, design, and construction of your buildings so that they can accommodate the equipment and tools?
    • What information or data can you provide about cleaning, sanitizing, and maintenance practices and procedures for equipment and tools that have wood, foam, or other porous or absorbent materials?
  • For domesticated and wild animals:
    • What data or information can you provide about factors or conditions that would affect the likelihood of contamination of covered produce by animals? Such factors include, for example, historical information and conditions on or near farms that influence animal habitats.

You can view the Draft Guidance here – remember that comments are due by April 22, 2019. NSAC urges farmers, individuals, and organizations to comment and provide additional information regarding what needs to be included in FDA’s Final Guidance document.


Categories: Food Safety


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