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Commenting on FSMA* …made easy
*Food Safety Modernization Act
November 4, 2013
Why This Webinar
• To assist growers in commenting on FSMA
• Deadline for comments is 11 days away
• All growers will be affected, via the market
• FSMA is complex; focus on key concerns
Today’s Topics
• Quick overview of FSMA rules
• Key areas of concern
• Elements of a strong comment
• How to submit comments
• FSMA info resources
• Your questions
FSMA Overview
• Law passed 2011, then rulemaking
• Two draft rules affect growers most
‘Produce Safety’ rule = farms
‘Preventative Controls’ rule = facilities
• Farms can also be a ‘mixed operation’
• Comment deadline: November 15, 2013
• Several years to final rule, implementation
Produce Safety Rule
• Personnel Qualifications, Training, Health and Hygiene: Subparts C, D
• Agricultural Water: Subpart E
• Biological Soil Amendments: Subpart F
• Domesticated and Wild Animals: Subpart I
• Equipment, Tools, Buildings, Sanitation: Subpart L
• Alternatives & Variances: Multiple Subparts
http://www.fda.gov/Food/guidanceregulation/FSMA/ucm334552.htm
Preventative Controls
Rule
• Written food safety plan, including:
• A hazard analysis
• Controls: process, allergens, sanitation, recall
• Monitoring procedures
• Corrective actions that would be used
• Verification activities
• Recordkeeping
Key areas of concern photo: http://gutschurch.com/
• These have been identified by the folks hosting this webinar but are not ‘official’ positions.
• Presented as short statements to help you develop comments – but use your own words!
• Slides will be posted so you can review later
• There are many more issues – these are addressed in the resources listed at the end.
Concerns Relevant to Both Rules:
Produce Safety and Preventative Controls
The definition of food should be changed. Only annual sales of fresh produce should be used to determine the $500,000 threshold for exemption from FSMA for local food -- not sales of all human and animal foods.
Otherwise, many small-scale produce farms that also grow and sell other kinds of food will have to comply with FSMA even though they sell very little produce. Some of these farms will decide to stop growing produce because of the cost of compliance.
Oversight of ‘Exempt’ Farms
Small farms and processors that are exempt from, or not covered by FSMA will be at a disadvantage in the marketplace. They may also have difficulty obtaining liability coverage.
State agencies of agriculture should be clearly authorized and funded to develop scale-appropriate food safety certification programs for farms and processors that are exempt from or not covered by FSMA.
Concerns Relevant to the Produce Safety Rule
Sales Threshold for FSMA Small farms that sell most of their product to wholesale markets will bear unreasonable financial and management burdens to comply with FSMA.
The threshold for a farm to be covered by FSMA should be increased from $25,000 in annual sales to $100,000. Farms with under $100,000 in sales, as well as those exempted by the Tester amendment (under $500,000 in ‘direct’ food sales) should be regulated by state-run food safety programs.
Agricultural Water
Weekly testing of surface water used for irrigation presents a large expense and is not proven to reduce risk. By the time lab results come back, they may not represent actual E. coli in water to be used. Also, there is insufficient data to support using recreational water standards for irrigation, especially when water is applied many weeks before harvest.
Ag water testing should be limited to 3 times per year, to be consistent with GAPs.
Biological Soil Amendments
The proposed 9 month wait after manure application until crop harvest means that manure must be applied in the year prior to crop production. This will lead to water pollution and loss of nutrients. Many growers will seek to avoid using manure and this will increase costs to use compost and bagged fertilizers to meet crop nutrient requirements.
The manure waiting period should be changed to 120 days until harvest, to be consistent with the National Organic Program and GAPs.
Personnel Training
Requiring formal training of a supervisor who will then train for all farm personnel as they are hired is not practical for small and medium size farms.
Training for farm employees on these farms is achievable with simple written materials that describe basic standards for hygiene, sanitation and operating procedures. These should be posted at the farm and be required reading for all employees.
Concerns Relevant to Preventative Controls Rule
photo: http://gapersblock.com
Co-Packing or Holding Produce
Washing, packing and/or holding produce from other farms that are in compliance with FSMA or another accredited food safety program should not put farms under the Preventative Controls rule as it will create unreasonable costs for compliance.
If produce delivered from the other farms is in labeled containers and its end use is recorded, it will be traceable even if co-mingled during washing, packing or holding.
Cooperative Marketing
Cooperative marketing or aggregation of produce from a variety of farms that are in compliance with FSMA or another accredited food safety program should not come under the processing rule as this would limit efforts to build strong local and regional food systems.
If produce from all farms is in labeled containers, and its end use is recorded, it will be traceable by lot even if co-mingled or processed.
Threshold For Full Compliance With Preventative Controls Rule
photo: New England Apple Association
Very Small Businesses under $1 million pose a small food safety risk and they cannot afford the cost of full compliance with the preventative control rule.
Very Small Businesses (only subject to modified preventative control requirements) should be defined as those with less than $1 million in total annual sales of fresh produce and processed food, not annual sales of all food.
Elements of a Strong Comment
photo: http://grade2mk.global2
• Describe your food business and the role it plays in the local / regional food economy.
• Give specific examples of how the proposed rule would affect your farm and what problem it poses for your business (finances, operations, markets)
• Offer alternative solutions that could work for your operation- it is important to not complain but make thoughtful and practical suggestions.
• If there are aspects of the rule you like, be sure to share those too.
Comment Nuts and Bolts
• Prepare a word document ahead of time
• Paste in or upload comment on FDA website(s)
• Remember, comment on each rule separately
• Comments are part of the public record
• Do not wait to the last minute
Where to Submit Comments:
Produce Safety Rule:
http://www.regulations.gov/#!submitComment;D=FDA-2011-N-0921-0199
Preventative Controls Rule:
http://www.regulations.gov/#!submitComment;D=FDA-2011-N-0920-0188
Send a copy to your congressional reps, so they know of your concerns.
FSMA Info Resources • FDA's website:
http://www.fda.gov/Food/GuidanceRegulation/FSMA
• National Sustainable Agriculture Coalition: http://sustainableagriculture.net/fsma
• University of New Hampshire Cooperative Extension: http://extension.unh.edu/Food-Safety-Modernization-Act-FSMA
• New England Farmers Union: http://www.newenglandfarmersunion.org/food-safety-modernization-act
Questions?
Type in the chat box now…
sample
comments are next
are we having fun yet?
photo: http://www.farhanadhalla.com
Sales Threshold for FSMA: (for a farm with food sales of $25,000 to $100,000) We are beginning farmers with a small diversified farm, who have been farming for XX years. Although our annual gross sales are now $XX,XXX, our business is growing and we will surpass that soon. We would like to expand our wholesale markets but cannot plan to do so if it means we must then comply with the Produce Safety rule even though our business is quite small. The costs would be prohibitive. We believe the threshold for farms under the modified exemptions category should be moved from $25,000 to $100,000 and that we should be regulated by our state agency of agriculture.
Agricultural Water Testing: (for a farm using surface water for irrigation) I run a vegetable operation that uses overhead irrigation on XX acres of fields as needed during a 24 week growing season. We draw water from a farm pond and two locations on a stream. Assuming 12 weeks of irrigation, 3 tests per week and $50 per test for analysis and overnight shipping, my annual cost would be $1800. If it requires 1 hour to sample and mail the tests each week that is an additional 36 hours or $720 in labor cost, adding $2500 to my operating expenses. This is a lot of money for a procedure that is not backed by scientific consensus to reduce food safety risk. Please change the Produce Safety rule to require water testing 3 times/year, as with GAPs.
Biological Soil Amendments: (for farms that apply raw or partially composted manure) My certified organic vegetable is on XX acres. Using manure from nearby dairy farms helps me get low cost nutrients and organic matter, and it helps my neighbors manage their manure. I spread manure in the spring prior to planting to make the most nutrients available to my crops and to allow 120 days to harvest so I comply with the organic standards. I cannot spread manure before April 1 under Vermont’s Accepted Agricultural Practices. I cannot apply manure the year before since there are crops in place. Since I cannot use chemical fertilizers I would have to buy compost as a source of nutrients, costing me at least $XXXX more per year. Please change the Produce Safety from a 9 month to 120 day wait after manure application, to align with both NOP and GAPs.
Personnel Training (for farms with any employees) I own and operate a diversified produce farm with $XXXX in annual gross food sales. I employ an average of XX part-time field hands each season, some of whom are students or others that work just a few weeks. I can’t afford to continually and individually train every worker on food safety procedures. For a farm my size, an economically appropriate solution would be to have a set of written basic standards for hygiene and sanitation that each employee is required to read, and to post standard operating procedures at all work stations. These standards should be based on the current requirements in conventional USDA GAPs that growers are familiar with.
Co-Packing or Holding Produce (for farms that hold or pack produce from other farms) Our farm buys and sells fresh produce from other farms in order to fill orders and maintain consistent supply so we can access wholesale markets. In a practical sense, we do not process food, but simply hold or co-pack clearly labeled produce and ship it to customers. If all farms that provide produce though this co-packing chain are held to FSMA regulations, and all the produce is tracked, then we should not be required to comply with the Preventative Controls rule. That rule would impose significant management costs on our farm and force us to abandon our cooperative marketing, which will negatively impact the local food system.
THE END
