2014_11-FSMACompost, water, wildlife, costs to farmers and processors – some good changes were made in the FDA’s latest revisions to the Food Safety Modernization Act, but there is still a LOT that needs to change!

As currently proposed, the rules will:

  • Squash local food: the proposed rules unfairly burden local and regional food innovations and limit opportunities for family farmers to launch and grow their businesses
  • Undermine sustainability: the proposed rules make it harder for farmers to use sustainable methods to protect soil, water and wildlife.
  • Raise costs: the proposed rules impose major expenses on small farms and food businesses and lack fairness, clarity, and consistency.

The National Sustainable Agriculture Coalition (NSAC) has done an incredible job of putting together info that will help you figure out if you’ll be affected by the proposed rules, highlight the top changes, and explain in-depth the various issue areas.

Click here for a summary of the top 10 fixes and fails in this update.

Click here for a flowchart that can help you identify if you’ll be affected by the Produce Rule, Preventive Controls Rule, or BOTH.

Click here for in-depth information on each of the major changes you might want to comment on.

Click here for info on how to make comments to the FDA: Due by December 15th!

If you have a story about how these rules will impact your farm, PLEASE consider sharing your story!  Showing real-life impacts is the most helpful way to make decision-makers understand the implications of your actions.  NSAC is collecting stories to share with the media around the country.  Click here to share your story.


Although all of these issues have the potential to impact Montana’s farmers, there are a key few that we’re most concerned about.  We recommend you read through all of the key issue areas on NSAC’s website (see link above), but here are a few we’re most concerned about in rough order of importance (much of the info below comes from NSAC’s work):

Ag Water: PR

Background: While many farmers in Montana have switched a portion or all of their watering to drip irrigation, many still use direct water application through pivots, hand lines, etc.  The revised PR added some flexibility to the water standard but it is still requiring that farmers adhere to a “recreational” water quality standard that is totally unnecessary and is still including costly, unscientific standards like overly burdensome water testing requirements.  Here’s an example from NSAC: A farmer who uses water from a stream on his property to irrigate his fields (though not using drip or furrow irrigation) would be required to first take at least 20 samples over a minimum two year period to develop a water quality profile for each water source, and then verify the profile with 5 samples annually. Every 10 years, the farmer would have to re-establish a 20-sample baseline.   FDA may allow the farmer to rely on some past test results, but in certain instances where there is a significant change in water quality, FDA may require all new samples, even if the source of the problem is outside the farmer’s control.

Ask: FDA should not overly burden farmers to test and address water quality issues outside of their control.  FDA should take a risk- and science-based approach to determine an appropriate water quality standard and should defer finalizing a numeric standard until a full risk assessment is completed.  Any numeric standard should be in guidance, not the regulations.  FDA should reduce the frequency of testing and should provide the farmer with the flexibility to determine the number of tests needed to establish a baseline.

Thresholds for Eligibility: Produce Rule (PR) and Preventive Controls Rule (PCR)

Background: FDA originally proposed that it would determine whether a farm qualified for an exemption based on their sales of all food.  They’ve since updated it to be based on sales of total produce, but not all produce is covered under the regulations.

Ask: In the Produce Rule, only covered produce should count towards the threshold for eligibility and in the Preventive Controls Rule, only covered product should count.

Illegal Onsite Audit Requirement (Supplier Verification Program): PCR

Background: FDA is requiring facilities to make their suppliers have and pay for onsite audits (explicitly prohibited by Congress) – separate from and in addition to any requirements the farm would be subject to under the Produce Rule or under existing programs like GAP.

Ask: FDA must comply with Congress’s intent and remove the onsite audit requirement. FDA should remove the supplier verification program entirely from the regulations.

Excessive Costs of Environmental and Product Testing: PCR

Background: The proposed rules include significant requirements for facilities to complete environmental and product testing – like taking samples of work surfaces and products and testing them for pathogens.  Here’s an example from NSAC: For a small facility (under 20 employees) preparing raw salads for sale, the new environmental monitoring provision alone is estimated to cost $2,891 annually. The product testing provision would cost an additional $12,000 annually just for the testing – for facilities that also have to hold products while waiting for test results, FDA estimates the total costs of testing and holding to be over $28,000 annually. These provisions impose significant added burden on facilities, and the farmers that supply them, particularly for those producing multiple crops and food products.

Ask: FDA must find ways to decrease the costs of compliance, especially for small farms and facilities.  FDA should take a flexible approach to environmental monitoring and product testing and should only include them in guidance, not regulations.

Direct-to-Consumer Marketing: PCR

Background: Although Congress clearly instructed the FDA to clarify that CSA drops, farmers markets, and other direct-to-consumer marketing strategies are not “facilities” (and therefore, not subject to preventive controls rules), the proposed rules fail to make that clarification.

Ask: Clarify that CSAs, roadside stands, farmers markets, and other direct-to-consumer vendors fall under the definition of a “retail food establishment” and thus are not facilities that must register with the FDA and are not subject to the Preventive Controls Rule.  Also, FDA must issue the separate rule defining “retail food establishments” immediately and allow sufficient time for public review and comment.

Conservation Practices: PR

Background: The original rules had the potential to make it difficult, if not illegal, to enact on-farm conservation practices that provide pollinator and wildlife habitat, encourage grazing as part of crop rotation, and more.  Now the rules are better in that they now say that “nothing in the regulations require covered farms” to remove conservation practices, but a good rule should encourage conservation practices!

Ask: FDA should state that farmers are encouraged to use conservation practices and should include requirements to train personnel on how conservation practices support food safety goals.

Farm/Facility Definitions: PR and PCR

Background: Figuring out whether your operation is a “farm” or “facility” is one of the most confusing parts of the rule.  For example, “drying grapes to make raisins is a farm activity, but slicing applies into rings and then drying them is no longer a farm activity.” (NSAC)

Ask: The FDA should clarify the “farm” definition to ensure that it is clear and concise and to ensure that farmer operated and controlled businesses (like WMGC) that engage in “farm” activities, including packing or holding raw commodities, are farms, regardless of whether the “farm” activities are “on-farm” or “off-farm.”  Also, FDA should remove the phrase “in one general physical location” from the farm definition since farms are not always contiguous and structures may be in different locations.

Manure and Compost: PR

Background: The FDA re-aligned their compost rules with the National Organic Program and has deferred finalizing the standard for 5-10 years while it conducts a thorough risk assessment.  This is a good thing, but we need to ensure that farmers stay a part of that discussion and research.

Ask: Involve producers in this ongoing process!

Paperwork and Recordkeeping Requrements: PR and PCR

Background: FDA is requesting comments on whether farms that pack and hold ag products for other farms should retain records and if so, for how long.  For example, if there is a produce drop site on your arm, you might be required to retain records, invoices, or packing slips for each transaction.

Ask: Records should be limited to those kept in the ordinary course of business.  NSAC recommends that FDA should require farms to retain, for no more than one year, a 1 up-1 down record (i.e. where it came from and where it went), such as an invoice.

Thoughts? What are your biggest concerns?  Stories of how this will impact your farm?