- Author: Shermain Hardesty
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: firstname.lastname@example.org. 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
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 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 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: email@example.com. I would like to incorporate them (without identifying the source) into my response to the FDA.
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