- 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: Shermain Hardesty
How can I begin to describe the draft regulations for the Food Safety Modernization Act (FSMA)?
On January 4, 2013, FDA came out with two sets of proposed rules, stating that comments from the public are due by May 16, 2013. One set of proposed rules relates to processed foods and the other one to produce. There are three additional sets of proposed rules yet to come; they are related to: imported produce and other foods; accreditation of third-party auditors in other countries; and preventive controls at animal food facilities that are similar to those proposed for human foods. For now, I am limiting my commentary to the produce-related rules.
This proposal applies to the produce industry (including farmers) and is called the Standards for Growing, Harvesting, Packing and Holding of Produce for Human Consumption Proposed Rule (144 pages); it focuses on areas of risk for fruit and vegetable production, including agricultural water; biological soil amendments; health and hygiene; domesticated and wild animals; and equipment, tools and buildings.
The FDA estimated that 1.75 million cases of foodborne illness would be prevented annually by this regulation, with an annual benefit of $1.04 billion. They estimated that compliance with the proposed rule will cost domestic farms $459.6 million. The estimated average annual cost for very small farms (less than $250,000 in annual revenues) is $4,697, $12,972 for small farms (between $250,000 and $500,000 in annual revenues) and $30,566 for large farms.
Reading through the proposed rules is not a simple process. I suggest starting with the published summary, which is available at:
http://www.fda.gov/Food/FoodSafety/FSMA/ucm334114.htm?source=govdelivery
Small farms would be eligible for the qualified exemption; they must meet all of the following conditions during the 3-year period preceding the applicable calendar year:
1. Their average annual revenues were less than $500,000 (adjusted for inflation);
2. Their average annual revenues from products sold directly to consumers, stores and restaurants exceeded the average annual revenues of the farm’s sales to all other buyers;
3. Their direct market sales occurred in the same state as the farm, or within 275 miles of the farm (whichever is greater); and
4. The name and complete business address of the farm where the produce was grown are conspicuously displayed at the point of purchase, if the produce is not otherwise labeled.
I will be back with more information regarding the FSMA’s proposed rule for produce by the end of February.
Shermain Hardesty, shermain@primal.ucdavis.edu
- Author: Shermain Hardesty
Small-scale growers can get reimbursed for part of their food safety audit, testing, or training expenses.
California’s Department of Food and Agriculture (CDFA) has a reimbursement program to assist specialty crop producers with the cost of first time food safety audits, informational assessments, water and/or soil testing, and training regarding Good Agricultural Practices (GAPs). Small-scale growers can be reimbursed for up to $200 for these expenses.
To request a reimbursement, growers should download the application form, complete it, and mail it to CDFA as indicated on the form. Only completed applications with original signatures will be processed. Funds are available on a first come, first serve basis until the funds are depleted, or July 31, 2013.
- Author: Brenda Dawson
For consumers, the effects of food safety practices can seem simple, though critically important: You’re either sick from the food you eat or you’re not.
But for producers, food safety comes in many shades of risk at many critical points in their business operations: water testing, worker hygiene, harvest techniques, postharvest cooling and storage, previous land use, wildlife and more.
To help small-scale farmers better plan for food safety concerns, several UC Cooperative Extension farm advisors are being trained in food safety audits and are planning food safety workshops. The project is led by Shermain Hardesty and Richard Molinar of the Small Farm Program, with funding from the UC Division of Agriculture and Natural Resources.
The group is beginning to offer workshops for farmers in eight regions of California.
Why now?
New FDA regulations are being developed for the Food Safety Modernization Act that will affect food producers, among others. The act includes an exemption for farms whose annual sales were less than $500,000 on average during the last three years, with the majority of their product sold directly to consumers, farmers markets and restaurants within the state or within a 275-mile radius.
"Even though it exempts many small farmers, the Food Safety Modernization Act says the exempt producers would still need to comply with any food safety regulations from state and local governments," Hardesty said.
Trevor Suslow, UC Cooperative Extension specialist in food safety at UC Davis, has said that the FDA can withdraw the exemption with cause.
“Whether or not the exemption will hold, I think, is incumbent on everybody,” he said.
He expects the regulations will be implemented in tiers, with smaller farms having three years to comply once the regulations are final.
Even without regulations in place, more buyers — including packinghouses, retailers and at least one certified organic distributor — are requiring farmers to meet food safety standards. Insurance companies are also, in some instances, cancelling policies or hiking rates for small farmers who have not documented their food safety practices, according to Hardesty.
Many farmers who work with large packinghouses, sell to major distributors or are members of a commodity-specific commission have already established their food safety practices to adhere to standards of their industries.
But smaller farmers who grow multiple crops or who aren't part of a commission may still be looking for food safety guidance, which these workshops aim to provide.
"Most of the growers I work with are exempt, but even so, they are very concerned about how it will affect them," said Cindy Fake, one of the UC Cooperative Extension farm advisors who is part of the project and works in Placer and Nevada counties. "There is a lot of awareness of what is coming down the line."
Food safety basics
The workshops will include presentations about food safety as it relates to regulatory and business trends, previous land use, workers, water, wildlife, waste, soils, harvest, transportation, traceability and farm mapping. What should a farmer do with all this information?
“First and foremost, farmers should have some sort of food safety manual, a written food safety manual for their individual farm,” explained Richard Molinar, UC Cooperative Extension farm advisor in Fresno County. “And then if they want or need to be certified, that’s a second step with a third-party auditor.”
In his session, Suslow examined the link between fresh produce, outbreaks and illnesses. Leafy greens, melons and tomatoes have been associated with a combined 65 percent of produce-related outbreaks, between 1996 and 2009.
He listed key areas of food safety for all farming and shipping:
- Water: pre-harvest and postharvest
- Workers: hygiene and training
- Waste: manure and compost
- Wildlife: intrusion and fecal
- Recordkeeping
- Traceability
Food safety programs, he explained, depend on multiple hurdles to help prevent biological, chemical and physical hazards from entering food, surviving, growing and persisting.
Cold chain management is one critical aspect of postharvest food safety. Bacteria can double in a very short period of time if cold chain management is neglected.
“In just a few hours, you can go from something that won’t affect most of us to something that would make you sick,” Suslow said.
Workshops
Food safety workshops for this project will be held in multiple regions around the state. The first such workshop, scheduled for April 12 in Santa Rosa, has already sold out.
Registration is available for the next food safety workshop, May 3 in Stockton. The workshop is free to attend, though pre-registration is required.
Additional workshops will be planned by UC Cooperative Extension farm advisors participating in the project, who are located in Lake, Sonoma, San Joaquin, Placer, Nevada, Santa Clara, Fresno, Ventura and San Diego counties.
All food safety workshops associated with this project will be included on the Small Farm Program's calendar as well.
Some additional resources, recommended by farm advisors on this project:
- Creating a food safety manual:
- California small farm food safety manual from UC Cooperative Extension
- On Farm Food Safety project is part of Familyfarmed.org and can help farmers create a customized food safety plan. Suslow was a technical advisor to this project, along with a national team of stakeholders and specialists.
- Good Agricultural Practices Food Safety Plan template from Penn State Extension
- Books from UC ANR:
- Small Farm Handbook includes a chapter on postharvest handling and safety of perishable crops
- Organic Vegetable Production Manual includes a chapter on postharvest handling for organic vegetable crops
- Free publications from UC authors (PDFs)
- Postharvest chlorination
- Water Disinfection: A practical approach to calculating dose values for preharvest and postharvest applications
- Postharvest Handling for Organic Crops
Back to the newsletter: Find more Small Farm News articles from our Vol 1. 2012 edition.
