In early January, 2013 the FDA issued two sets of proposed regulations related to the Food Safety Modernization Act (FSMA) that could have significant impacts on farmers—small- and large-scale: the Produce Rule and Preventive Controls Rule for Human Food.  The deadline for comments has been extended twice; it appears that November 15, 2013 will be the final deadline.  Links and more information about submitting your comments to the FDA are below.

As I work on drafting my comments to submit to FDA about these proposed rules, it would helpful to get your input about the proposed rules. Please send your comments by November 8 to: shermain@primal.ucdavis.edu. Please share your thoughts about how the proposed rules would impact your farming operation.

Below, I have summarized some key provisions and provided links to other sources. I hope that you can take some time to review this information. FDA’s proposed rules could have a significant impact on your farming operation.

Proposed Rule on Preventive Controls for Human Food

Background

The Rule on Preventive Controls for Human Food (Preventive Controls Rule) proposes that firms have written plans in place to identify potential hazards, put in place steps to address them, verify that the steps are working, and outline how to correct any problems that arise. The Preventive Controls Rule would apply to facilities (including farms) that manufacture, process, pack or hold human food.  Specifically, the rule applies to farms that are considered to be a “farm mixed –type facility”. Such farms grow and harvest crops or raise animals, AND handle crops that are not grown, raised, or consumed on any farm they own, AND/OR they pack, process or hold food produced on their farms that is not consumed on any farm they own. 

The rule requires each facility covered by the rule to prepare and implement a written food safety plan, which would include the following: hazard analysis; risk-based preventive controls; monitoring procedures; corrective actions; verification; and recordkeeping.

These are some problems I see with the Proposed Rule on Preventive Controls:

Clarification is needed

The proposed Preventive Controls Rule includes provisions for exemptions and modified requirements. However, they are extremely difficult to understand. The relevant sections of the rule need to be clarified, as well as the associated guidance documents and educational materials.

Packing and Holding Activities should be explicitly exempt

Packing, sorting, grading and storing produce grown on the farm does not trigger the manufacturing/processing definition; however, these same activities involving produce grown on another farm classifies the farm as a “farm mixed-type facility”.   These low-risk activities should be explicitly exempted from the requirements of the proposed rule.

Community Support Agriculture (CSA)s, Farmers Markets and Farm Stands must be explicitly identified as retail food establishments

The Food Safety Modernization Act includes language that specifically instructs the FDA to amend the definition of a retail food establishment to include CSAs, farmers markets and roadside farm stands. Under pre-existing law, retail food establishments are not “facilities” anddo NOT have to register with the FDA (the definition of “facility” as used in FSMA comes from that used in the Bioterrorism Act). However, this amended definition is not included in the FDA’s Preventive Controls rule. The FSMA Facts document—I Have a Farm--Does the Proposed Preventive Controls Rule Affect Me? (http://www.fda.gov/downloads/Food/GuidanceRegulation/ FSMA/UCM365377.pdf) states:

“FDA intends[1] to amend the definition of “retail food establishment” to clarify that, in determining the primary function of an establishment, the sale of food products directly to consumers includes:

o   Sales of food to consumers at a roadside stand or farmer’s market and

o   Sale and distribution of food through a community –supported agriculture program.”

It is curious, nevertheless, that FDA did not simply include a similar statement in the proposed rule, despite the specific instructions in the FSMA. Furthermore, the word “intends” does not project the same level of certainty or commitment, as would a mandatory word such as “shall”.

Thus, CSAs and roadside stands that handle produce from another farm could be subject to the same manufacturing-related regulations as a large-scale fruit cannery; they would have to register with the FDA and comply with Hazard Analysis/Preventive Controls requirements. This vulnerability must be eliminated by including an amended definition of a retail food establishment within the proposed rule.

Key links regarding the Proposed Rule on Preventive Controls for Human Food:

Summary by FDA:http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM360735.pdf

Summary by National Sustainable Agriculture Coalition: http://sustainableagriculture.net/fsma/overview-and-background/what-is-the-preventive-controls-rule/

          Check out if it applies to you as a farmer: http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM365377.pdf

 Text of Proposed Rule: http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0920-0001

 Comment on the Proposed Preventive Controls Rule: (click on the blue box in the upper right- hand corner: http://www.regulations.gov/#!submitComment;D=FDA-2011-N-0920-0188

Please send your thoughts about how the proposed rules would impact your farming operation by November 8 to: shermain@primal.ucdavis.edu. I would like to incorporate them (without identifying the source) into my response to the FDA.