- 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: 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 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.
[1] Bold face font added.
- 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: 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
1st Year and Annual Average Impact of Produce Rule Compliance Costs
On Average Net Cash Farm Income by Farm Size
|
|
Very Small ($25,000-$249,999) |
Small ($250,0000-$499,999) |
Large ($500,000) & over |
|
Average Annual NCFI1 |
$11,305 |
$77,159 |
$933,189 |
|
Average Annual Cost per farm |
$4,697 |
$12,972 |
$30,566 |
|
Average 1st Year Cost per farm |
$8,260 |
$20,470 |
$38,133 |
|
|
|
|
|
|
NCFI – 1st Year Cost |
$6,608 |
$56,689 |
$895,056 |
|
NCFI – Annual Cost |
$3,046 |
$64,187 |
$902,623 |
|
|
|
|
|
|
1st year NCFI decrease (%) |
73.0 |
26.5 |
4.1 |
|
Average annual NCFI decrease (%) |
41.6 |
16.8 |
3.3 |
[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
- Author: Penny A. Leff
Turns out coffee can grow, quite successfully in California. We're happy to share this post and video by Katherine Spiers about Jay Ruskey, a Santa Barbara coffee grower who received the Pedro Ilic award in 2010.
- Author: Penny A. Leff
USDA Rural Development has published the Notice of Funds Availability (NOFA) for the Value Added Producer Grant (VAPG) program. The Application deadline is October 15th, 2012. In this program agricultural producers or producer groups may apply for either a feasibility study grant (maximum $100,000) or a working capital grant ($300,000 maximum). Eligible activities must be related to the processing and/or marketing of valued-added agricultural products.
There is a matching funds requirement of at least $1 for every $1 in grant funds provided by the Agency (matching funds plus grant funds must equal proposed total project costs.
Grants will be awarded competitively for either planning or working capital projects directly related to the processing and/or marketing of value-added products. Generating new products, creating and expanding marketing opportunities, and increasing producer income are the end goals. Applications that support aspects of regional strategic planning, cooperative development, sustainable farming, and local and regional food systems are encouraged. Proposals must demonstrate economic viability and sustainability in order to compete for funding.
For additional information and application procedures, visit the USDA website. http://www.rurdev.usda.gov/BCP_VAPG.html. The USDA Rural Development’s VAPG liaison for California is Karen Firestein; her office is in Davis and her contact information is: 530 792-5829, Karen.firestsein@ca.usda.gov.
- Author: Brenda Dawson
Calling all small-scale farmers and their supporters! Now is the season of awards and conferences in the agricultural world — and that goes for small-scale farmers too. At the moment, we are seeking nominations for the Pedro Ilic Awards, which honor dedication to small-scale farming.
Each year, the awards honor an educator and a farmer who embody characteristics that helped make Ilic a success.
Anyone can write a nomination. Take a look at the nomination form, which is now online. The deadline for nominations is Jan. 31.
The awards will be presented at the California Small Farm Conference, March 4-6 in Valencia.
This conference, which rotates location each year, is the state's premier gathering of small farmers, agricultural students, farmers market managers and others involved in the small-farm industry. The three-day educational conference includes day-long short courses and on-farm tours; 25 focused workshops; keynote addresses (Karen Ross! Farmer Hallie Muller! Chef Michel Nischan!) and many networking opportunities.
Presentations at the conference from University of California experts will address food safety, starting a new farm, agritourism, new technologies, farming with limited water, how to recognize snake-oil-like products, and many other topics. You may want to check out the full list of workshops to get a better sense of the practical approach this conference takes to farming.
Other conferences coming up that small-scale farmers may be interested to attend include:
Know of others that I missed? Please tell us about them in the comments. More events for small-scale farmers are on the Small Farm Program's calendar.
And in the meantime: Do you know an outstanding farmer or agricultural educator? Honor him or her with a nomination for the Pedro Ilic Award!
