Important updates to the FSMA Water Rule - comments needed

Annalisa Hultberg, Extension Educator, food safety

On Dec 2nd, 2021 the FDA released the proposed revisions to Subpart E - Agricultural Water for the FMSA Produce Safety Rule. If you have attended a FSMA training in the past, you have learned about the previous rules for the use of agricultural water. After a long process of revision from the FDA, the agricultural water rule is now ready for comment from the public.  Read more about the proposed revisions from the FDA here.

Even if your farm might not be covered by the FSMA PSR, it is important to understand what the rule requires of growers, as the FSMA rule is industry standard and has implications for anyone that grows and sells fresh produce. 

Here are some key things to know about the proposed revisions to the ag water rule:

• The FDA said that they heard from a variety of stakeholders that certain pre-harvest microbial quality criteria and testing requirements in the previous rule were too difficult to understand, interpret, and implement.
  
  
• How is the proposed rule different? From the FDA: "The requirements in this proposed rule, if finalized, would replace the pre-harvest microbial quality criteria and testing requirements in the Produce Safety Rule with requirements for systems-based pre-harvest agricultural water assessments." 
  
  
• If finalized, farms covered by the Produce Safety Rule would be required to conduct an assessment of their pre-harvest agricultural water annually, and whenever a significant change occurs, to identify any conditions likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces.

• What water does this apply to? The FDA is only proposing changes to pre-harvest water, and is not proposing to change any requirements for harvest or postharvest uses of water. Generally pre-harvest water would be irrigation water, water used in crop sprays, and other field-uses of water that is applied before harvest.  Postharvest water, and water used in washing produce, cleaning tools, handwashing etc still must meet the standards in the previously published water rule and these standards did not change. 
  
  
• Enforcement discretion applies while the rulemaking process is completed and compliance dates are re-evaluated. That means that the existing provisions of Subpart E Agricultural Water will not be in effect until the rule making process is done.
  
  
  
  
  

All growers are encouraged to make comments on the proposed rule 

The FDA is seeking comments on the proposed ag water rule from growers and others who are impacted by the proposed rule. Electronic or written comments must be submitted on the proposed rule by April 5, 2022.  

Here are some guidelines for making comments on the proposed rule:

• First, read through FDA factsheets, and the full proposed rule. You can read the rule in this version, which is the three-column federal register format, or here in this PDF version.  Know that the majority of the beginning of the document contains background on the FDA's rationale for the proposed changes to the rule. The substantive changes to the rule begin on about page 46 of the PDF version.
• Then, go to the FDA Federal Register Docket to make comments.
• Reference the section number of the part that you are commenting on. For example, the section symbol might look like this §112.43 (a). Remember only Subpart E of the FSMA PSR is up for comment, so comments must be related to this subpart.
• Make your comments as specific as possible, and include what challenge the proposed rule might offer for your farm. Will it be difficult to implement? Expensive? Too time consuming? Offering these specific feedback to the FDA will help them determine how the proposed rule might need to be changed to meet the needs of produce growers and more easily implemented. 
• Offer suggestions or alternatives about what might work better for your farm, if something seems difficult to implement or understand.  For example, if you don't think it would be possible to meet a requirement of the proposed rule, indicate another example of how you might be able to reduce risk associated with agricultural water. 
• Keep comments professional and stick to the subject matter. 

If you have clarifying questions on the content of the rule, you can email the FDA at AgWater@fda.hhs.gov

Comments can be written and faxed to the FDA at (301)-827-6870 or mailed to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

In Minnesota, the Minnesota Department of Agriculture Produce Safety Program provides education and implementation on the FSMA. You can reach the PSP website here or by calling 651-539-3648 or emailing ProduceSafety.MDA@state.mn.us.