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 Produce Rule

Background

• agricultural water;
• biological soil amendments;
• health and hygiene;
• domesticated and wild animals; and
• equipment, tools and buildings.

A farm may establish alternative standards to certain of the proposed rule’s requirements related to water and biological soil amendments of animal origin. However, the alternatives must be scientifically established to provide the same amount of protection as the requirement in the proposed rule without increasing the risk of adulteration.

The proposed Produce Rule would not apply to farms that have an average annual value of food sold during the previous 3-year period of $25,000 or less. Small farms above this sales limit would be eligible for the qualified exemption; to qualify they must meet all of the following conditions during the previous 3-year period preceding the applicable calendar year:

1. Average annual revenues from all farm sales (not just the covered produce crops) is less than $500,000 (adjusted for inflation);

2. Average annual revenues from products sold directly to consumers, retail food establishments and restaurants exceeded the average annual revenues of the farm’s sales to all other buyers; and

3. These direct sales occurred in the same state as the farm, or within 275 miles of the farm (whichever is the greater distance).

However, all farms, including exempt and qualified exempt small farms, must comply with the Produce Rule's labeling requirement (Section 112.6). Specifically, if a food packaging label is required on the food, the label must "...prominently and conspicuously display, at the point of purchase, the name and complete business address of the farm where the produce was grown." If a food packaging label is not required, the farm must "...prominently and conspicuously display, at the point of purchase, the name and complete business address of the farm where the produce was grown, on a label, poster, sign, placard, or documents delivered contemporaneously with the produce in the normal course of business, or, in the case of Internet sales, in an electronic notice." The complete business address must include the street address or post office box, city, state, and zip code.

These are some problems I see with the Proposed Produce Rule:

Agricultural Water Testing Requirements are burdensome and not based on science

 The FSMA called for rules developed based on “…science-based minimum standards”.  However, in its proposed Produce Rule, FDA states that “there is a lack of sufficient information to support a pathogen-based microbiological standard for water used in the production of produce…” (p.3563).  Given this fact, it seems inappropriate and very unreasonable that the proposed rule imposes weekly water testing requirements when surface water is used for irrigation during the growing season.  The proposed food safety standard is not risk-based; there is no science to support the testing for the presence of generic E. coli as an indicator of the risk of fecal contamination. 

FDA estimated that each water test costs $80 if the laboratory collects the water sample; this cost includes the laboratory’s travel, analysis, and collection costs. If the grower collects the sample, the estimated test cost rises to $94.60. Many smaller farmers in California have long growing seasons; a grower with a 30-week growing season could spend $2,400 per field for such testing, if he or she is fortunate enough to find a lab that will come out to the farm. 

Soil Amendment Requirements conflict with organic practices

The FSMA explicitly states that the proposed rules developed by FDA “…in the case of production that is certified organic, not include any requirements that conflict with or duplicate the requirements of the national organic program established under the Organic Foods Production Act of 1990…”. However, the proposed FDA rule for untreated manure requires that there is a minimum application interval between application and harvest of 9 months. This is much longer than the standards set by the USDA National Organic Program (NOP) of 90 or 120 days.  Similarly, the interval from application to harvest of treated manure in the proposed FDA rule is 45 days, while the NOP does not require an interval between application and harvest for manure treated by a composting process consistent with the NOP’s standards.

Compliance with the Proposed Produce Rule can be expensive

FDA estimated that compliance with the proposed Produce Rule will cost domestic farms $459.6 million annually.  The proposed Produce Rule challenges the financial viability of California’s small farms. According to the most recently published Census of Agriculture (2007), very small and small farms in California operate, on average, with very small margins.  As shown in Table A below, adding the estimated average first year cost to comply with the Produce Rule reduces the very small farm’s net cash farm income (NCFI) by 73.0%, and by 41.6% for the annual average. For a large farm, the average impact of the cost of complying with the Produce Rule on its NCFI is only a 4.1% loss for the first year and 3.3% for the annual average.

Table A

1^st Year and Annual Average Impact of Produce Rule Compliance Costs

On Average Net Cash Farm Income by Farm Size

[1] Source: USDA-National Agricultural Statistics Service. 2007 Census of Agriculture

Below are some key links for the proposed Produce Rule:

Summary  by FDA: http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM359258.pdf

Summary by National Sustainable Agriculture Coalition:

http://sustainableagriculture.net/fsma/overview-and-background/what-is-the-produce-rule/

Text of Proposed Rule:

http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM360734.pdf

          Comment on the proposed Produce Rule: (click on the blue box in the upper right-hand corner)

          http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0921-0199

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.

My following post will address the Proposed Rule on Preventive Controls for Human Food