Background On The Issues With FDA’s Proposed FSMA Rules
And Questions To Help Farmers & Food Businesses Personalize Their Letters
1. Issue: Definition of a “Farm”
Background: “Farms” are excluded from having to do a Hazard Analysis and Risk-Based Preventive Controls (HARPC) plan, but the FDA’s definition of what is a farm is very narrow. For example, under FDA’s proposed definition, farms that do value-added activities will be subject to both the regulations for farms and the HARPC requirements.
The FDA did make some improvements from its first proposal, recognizing that simply packing or holding raw agricultural commodities from multiple farms should not require the farms to do a HARPC. However, since FDA is defining “farm” as an establishment “under one ownership in one general physical location,” many farms and food hubs could still get caught having to do a HARPC.
If you’re farm is in multiple locations or you are part of a food hub, multi-farm CSA, co-op, or any other multi-farm produce aggregation efforts, be sure to add personalized facts to explain how this issue will impact you:
• Is your farm made up of multiple parcels that aren’t right next to each other?
• Do you have packinghouse or other farm structures located on different parcels of land?
• Are you part of a food hub that aggregates products from multiple farms? Is the hub owned by one or more farmers? Is the food hub located on a farm property or elsewhere?
• Do you cooperatively own any of your farm buildings, including a food hub or packing house? If yes, is it located on your farm or someone else’s?
• If you pack and hold agricultural products both on your farm and off your farm, do you treat the activity differently? Do you think they pose different risks or the same risks?
2. Issue: Calculating Sales
In both rules, FDA determines whether and to what extent a farm or food business is subject to regulation based partly on a calculation of sales. Depending on sales, a farm or food business could have extended time for complying, be partially exempt, or fully exempt. Certain sales thresholds are calculated based on all food sales, others are based on produce sales, and still others on human food sales.
But the FDA doesn’t regulate livestock or meat. And the produce safety rule doesn’t cover dairy, eggs, or grain crops. Moreover, produce that is rarely eaten raw (such as potatoes) also are not covered by the produce safety rule. So why should sales of these items be include in any of these calculations? The FDA’s rules should look at the sales of what the rules actually regulate.
The inconsistent definitions will make it harder to determine how a farmer or facility should be characterized, and unnecessarily impose requirements on some producers who should be exempt.
If you are a diversified operation (raising produce as well as dairy, grain, eggs, livestock, etc, or selling value-added products), be sure to personalize your comments with facts about your situation:
• Do you grow a mix of produce that would be covered under the Produce Rule and produce that wouldn’t (i.e. produce that normally isn’t eaten raw)? Would it be easy for you to keep track of the sales from each category if FDA were to measure sales only based on “covered produce”?
• If you are a diversified farmer that raises produce, do you gross more than $500,000 in agricultural products other than produce (like grains, meat, eggs, or dairy)? How do your produce sales compare to your non-produce sales?
• If it means the difference between being exempt and not being exempt, will you avoid diversifying your farm and/or increasing your income from non-produce items?
Are you an on-farm processor or food hub? Do you gross more than $1,000,000 in total food sales? How much of that is in sales of food for humans versus food for animals (such as grains)?
3. Issue: Tester-Hagan Qualified Exemption for Local Farms and Food Businesses
The Tester-Hagan provision exempts farmers and facilities that gross less than $500,000 annually and who sell more than half their products directly to consumers or local retailers & restaurants, from the major requirements under the produce safety and HARPC rules. In the final negotiations over the Tester-Hagan exemption, Congress gave FDA authority to remove the exemption from individual farmers and facilities and subject them to the full weight of the regulations if there is a genuine food safety problem. Despite many comments in the first round of proposed rules, the new proposed rules still leave farmers largely at the mercy of local FDA personnel’s discretion, without normal due process protections.
You can read more detail about this issue in the sign on letter at http://bit.ly/sign-the-tester-hagan-letter. Whether you are submitting your own individual comments or not, you are invited to sign on to the joint letter in defense of the Tester-Hagan exemption.
If you are a farmer or food business who may be eligible for this exemption, be sure to personalize your comments with facts about your situation:
• Would you be able to come into compliance with the proposed rules within 60 days? 120 days? Or would that put you out of business?
• What type of documentation do you keep as a normal part of your business about your farming or production food safety practices, that could be used to respond to a notice from FDA that it was considering revoking your exemption because of unsafe practices?
4. Agricultural Water
The Produce Rule includes costly, unscientific standards for irrigation water, including water testing and treatment requirements. The agency is using the recreational water standard, which was developed to prevent gastrointestinal illness in swimmers. It was never meant to apply to irrigation management and does not account for the fact that microorganisms die off rapidly in the interval between irrigation and harvest.
Moreover, the presence of generic e. coli does not mean that pathogens are present; and, conversely, the absence of generic e. coli does not mean that the water is free from pathogens. Thus, setting the standard for irrigation water to test at a low level of generic e. coli imposes major costs on farmers without necessarily protecting for food safety.
No one knows how implementing this standard would affect American produce farming, but evidence suggests that a very significant percentage of surface waters would fail the test – forcing farmers to switch to groundwater (if that is even an option in their area), bear significant cost to chemically treat their water, or simply go out of business.
If you irrigate on your farm in any way, be sure to personalize your comments with facts about your situation:
• Where do you get your irrigation water? Do you have multiple sources? How many? (Each source will be subject to testing requirements independently)
• Do you test your water? If yes, what do you test for, how often do you test, what method do you use to test, and what does testing cost you?
• Given what you know about your water sources, how many tests do you think are necessary to establish a baseline of your water quality – namely, to determine what its normal quality is? How many tests would you need to do annually to verify that nothing has changed with your water?
• If you don’t test your water, what do you do to monitor the quality of your water?
5. Manure and Compost
FDA has made very significant changes to its approach on manure and compost, compared to the first round of proposed regulations. For compost that meets FDA’s standards, it is proposing that there will be no waiting period in between application and harvest, matching the National Organic Program’s guidelines. On manure (which, using FDA’s definitions, would also include such things as vermicompost, static compost, and many compost teas), the agency is deferring a decision until it has conducted a risk assessment.
These are significant improvements! But whether or not the regulations that the agency adopts in the future are truly risk-based or not will depend in large part on how its risk assessment is conducted.
If you use compost, compost teas, or manure on your farm, be sure to personalize your comments with facts about your situation:
• Do you use biological soil amendments of animal origin on your farm? If yes, what kind(s)? This would include compost, manure, vermicompost, compost tea, bone meal, etc.
• If you use manure, is it fresh, aged, composted, or put through some other process?
• If you make compost, what process do you use?
• How do you apply raw and/or composted manure on your field(s), and at what times of year?
• What are some of the greatest barriers to your access to and use of hot composted manure?
6. Domestic Livestock
The Produce Rule places arbitrary restrictions on integrating grazing animals into farm fields.
If you have livestock on your farm, be sure to personalize your comments with facts about your situation:
• What livestock do you have on your farm?
• Do you use livestock as working animals in your produce fields? What measures do you already take to avoid contamination of the crops by manure when you do so? What measures would be reasonable – and which ones would be infeasible?
• Do you graze livestock in your fields? What would be a reasonable waiting period in between grazing and harvest of the produce, based on your farm practices?
• Would a 9-month waiting period between grazing a field and harvest be practical for your farm? What would be a practical waiting period between grazing and harvest?
7. Conservation Measures
The Produce Rule fails to promote on-farm conservation practices that help protect our soil, water, and wildlife habitat and places arbitrary restrictions on integrating grazing animals into farm fields. Without explicit support in the rules, conservation practices like planting native plant buffers as bee habitat that are a win-win for conservation and food safety could be discouraged or, worse yet, forcefully removed
If you use any conservation practices on your farm or graze animals in your produce fields, be sure to personalize your comments with facts about your situation:
• Do you use conservation practices on your farm? What kind? Have those practices helped you address a food safety issue?
• Have you had to remove conservation practices to comply with industry or buyer food safety requirements?
• How can FDA make these standards better support diversified farming systems and biodiversity?
8. Records and Record keeping
FDA is requesting comment on whether farms that pack and hold agricultural products from other farms should retain records, and if so, for how long.
If you pack or hold (store) agricultural products on your farm from other farms, be sure to personalize your comments with facts about your situation:
• Do you have an on-farm food hub that aggregates produce from multiple farms for distribution? If so, do you already keep records or documentation of that?
• What kind(s) of documents do you keep (e.g. handwritten, electronic, invoices, packing slips)? Where do you store them? How long do you keep them?
• What additional burden (in time or costs) will you face if FDA requires you to keep additional records of agricultural products from other farms that you are packing and holding?
9. Supplier Verification program
FDA is requiring manufacturing and processing facilities to implement supplier verification programs for certain foods, to provide assurances that the supplier is following any applicable food safety regulations. Under certain circumstances, FDA is directing the facility to require an onsite audit of the supplier.
If you are a small processor, or you sell raw produce to processors or wholesalers, be sure to personalize your comments with facts about your situation:
• Do you already sell produce to wholesalers or processors? If so, do they already require an audit or something other certification scheme?
• Have you looked into, or tried in the past, to sell produce to wholesalers or processors and been prevented from doing so because of the cost of the required audits or certifications?
• Have you obtained market certification (such as through USDA GAPs) in order to access certain markets? If so, what do you think of that process? What does it cost?
• Are you a food hub or a small-scale food processor? Do you currently have supplier verification measures in place? If so, what type? What do they cost? If not, why not?
• If you are a farmer or a food processor, do you think FDA should require additional compliance requirements (in addition to the Produce Rule) on produce farms through supplier verification measures?
10. Environmental and Product Testing
FDA’s latest proposed rules added a new requirement for facilities to conduct environmental and product testing, in addition to the paperwork requirements of a HARPC plan. This massively increases the likely costs – which will either need to be absorbed by the facility or placed on the farmers who provide the raw ingredients.
FDA has acknowledged that these requirements mean that some farmers and facilities will go out of business, fewer people will start to farm, and more farmers will have to seek off-farm jobs to keep farming! The estimated costs of compliance exceed $28,000 annually.
If you are a facility that purchases fresh produce, or a farmer who sells fresh produce to wholesalers or processors, be sure to personalize your comments with facts about your situation:
• How will estimated costs of compliance that exceed $28,000 annually impact your operation? Will you be able to absorb these costs?
• Farmers: Do you currently supply produce to a wholesaler or facility? If so, do they require product testing? If so, what does that cost you?
• Are you a small-scale processor or food hub? Do you currently do any product testing or environmental testing? If so, what does that cost you?
• Please share any cost data on food safety plans, HACCP/HARPC requirements, or other food safety practices that you have and are comfortable sharing with FDA.
11. Definition of “retail food establishment” and direct-to-consumer sales
The Bioterrorism Act of 2002 required that any business that holds, packs, or processes food must register as a “facility.” Both “farms” and “retail food establishments” are exempt from the requirement – and, thus, they are exempt from the new HARPC requirements for facilities under FSMA. But the key issue is how these terms are defined. Many farms would be classified as “facilities” under FDA’s definition, for making value-added products.
The FDA defined a “retail food establishment” as a business that sells the majority of its products directly to individual consumers (not including restaurants, retailers, or other businesses). But the regulation implies that the location of the sale must be at the same location as the business.
The Tester-Hagan amendment directed the FDA to clarify the definition to ensure that anyone who sells their products directly to consumers would be classified as a “retail food establishment,” even if the location of the sale isn’t at the place where the food was produced. In other words, producers who sell at farmers markets, or distribute through drop points, etc. would still be “retail food establishments” and not facilities subject to the extensive new regulations for food facilities.
FDA has failed to include this definition in its proposed regulations, despite the clear Congressional directive.
If you make value-added products and sell mostly to individual consumers, be sure to personalize your comments with facts about your situation:
• Do you operate a CSA, farmers market, or other direct-to-consumer outlet? Do you have off-site drop off locations?
• How might being subject to the requirements for a HARPC plan and other regulations as a “facility” impact your operation?
12. Definition of “very small businesses” in the facilities rule
In response to comments in the last round, FDA is defining “very small business” in the facilities rule as businesses that gross $1 million or less. “Very small businesses” that engage in only low-risk activities (as defined by FDA) will be exempt from having to develop a HARPC plan. In addition, those very small businesses that do have to develop a HARPC plan will have additional time to do so.
This is a very positive development and we need to submit comments in support to ensure that FDA stays with this position!
NEXT: Take action by submitting your comments to FDA!
Submit your letter online at: http://bit.ly/produce-rule and http://bit.ly/facilities-rule (submit a copy at both links)
Or mail to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20852
Sample Letter for Farmers or Facilities
Remember to personalize it and add information about your farm or business in the relevant sections!
Re: Preventive Controls Rule: FDA-2011-N-0920, Produce Standards Rule: FDA-2011-N-0921
I am a ____ [farmer, processor, food hub, member of a farmer co-op…].
[Personalize your comment at the beginning with a couple of sentences: What is the name and location of your farm or business? What do you grow/sell? How long have you been in operation? ]
I am writing because I am concerned about the impact that FDA’s re-proposed FSMA rules will have on [my farm / business, other farmers in my community, the farms that I buy raw produce from, etc.]. I urge you to change the proposed rules to ensure that they do not burden small farms and food businesses with unnecessary costs or ambiguous and vague requirements.
I am specifically concerned about the issues discussed below:
1. Definition of a “farm”: FDA should not classify “farms” as “facilities,” and thus impose additional regulations on them, unless there is a specific risk-based reason to do so, not simply because of legal technicalities or unrelated issues. Specifically:
* FDA should clarify the “farm” definition to ensure that farmer-operated businesses that engage in farming activities — growing, harvesting, packing, or holding raw agricultural commodities — are considered farms.
* FDA should remove the phrase “in one general physical location” from the farm definition, to reflect the fact that farms are not always contiguous and that farms may include structures in different locations or on different parcels of land; these aspects do not increase the risk of foodborne illness.
* FDA should remove the phrase “under one ownership” to reflect the fact that farmers may join together in food hubs and cooperatives to market their products without increasing the risk of foodborne illness.
2. How to calculate sales for determining the size of the farm or business: When Congress passed FSMA, it did not give FDA authority over all types of food. This rule creates a lower threshold for regulation of diversified farms by including ALL farm commodities, including livestock, grains, etc. as well as covered vegetable crops. In addition, FDA has already recognized that even some of the types of food within its jurisdiction should not be covered by the new rules.
These limitations on the scope of the FSMA rules should be reflected in the calculations of sales in determining whether and to what extent a farm or food business is covered under the rules. Thus, for all coverage determinations, FDA should base thresholds on sales of “covered produce” under the Produce Rule and “covered human food” under the Preventive Controls rule.
3. Qualified Exemptions under the Tester-Hagan amendment: FDA should implement the Tester-Hagan provisions in a manner that respects normal principles of due process and that doesn’t risk pushing a small-scale producer out of business with a too-hasty or erroneous decision to revoke their exemption and too-short deadlines for compliance.
I support the agency’s inclusion of a procedure to allow for re-instatement of the exemption. I urge the agency to make the following additional changes:
* Require that FDA include a specific statement of the reasons in the notice of revocation, so that the producer can respond to the specific issues of concern.
* Require FDA to have probable cause before initiating an investigation of an exempt farmer or food facility, and to present clear and convincing evidence for revoking the exemption.
* Provide appropriate time (at least 90 days) for producers to submit the facts and documentation showing that their exemption should not be withdrawn.
* Guarantee a hearing so that producers can present their case in person before having their exemption revoked.
* Provide the standard post-decision procedural protections, such as motion for reconsideration and a motion for stay.
* Specify that the reinstatement would occur within a reasonable period of time.
* Provide at least one year for a previously exempt farmer or producer to come into compliance with the FSMA regulations after revocation. Large farms and manufacturers are given a year to come into compliance – requiring these small and micro-businesses to comply in a shorter time period would effectively drive them out of business.
4 Agricultural Water: As directed by Congress in FSMA, FDA needs to take a science- and risk-based approach to regulation. The proposed requirements for irrigation water do not do so.
* The water quality standard, based on recreational use, is both unnecessary and overly restrictive. The FDA should not set a numeric standard until it has conducted a risk assessment specifically for water for agricultural purposes.
* The requirements for testing need to be clarified, including the options for when a farmer may test less frequently or use water that exceeds the standard in accompaniment with a confusing time delay logarithm between irrigation and harvest. The current proposal is extremely confusing and will inevitably lead to both higher costs and violations for farmers who simply can’t figure out how to reasonably comply.
* FDA should reduce the frequency of testing, requiring no more than 3 samples per growing season. As currently proposed, the testing frequencies are overly burdensome, lack scientific justification, and will impose significant costs on farmers.
* FDA should provide farmers with the option to test for pathogens if a water source has exceeded the standards for generic e. coli, rather than having to treat or stop using the water, since the presence of generic e. coli does not mean that pathogens are present.
* I support the FDA’s proposal to allow a farmer to use testing by third parties to monitor his or her water sources. FDA should clarify what facts must be established, such as how far from the farm the third party samples may have been taken and still qualify.
5. Manure and Compost: I fully support FDA’s decision to require no waiting period in between application of compost and harvesting of the crop. I also support FDA’s decision to refrain from establishing a waiting period for the application of manure until further research is done.
As FDA moves forward with the research on the safety of manure applications (which, under FDA’s definitions, would also include applications of vermicompost, static compost, and most compost teas), FDA should provide for an advisory board that includes representatives of all types of agricultural production, including conventional, certified organic, and sustainable production. It is vital that working farmers be included in the process.
6. Domestic Livestock: FDA should not treat grazing like manure application and should not restrict diversified farmers through unrealistic intervals between grazing a field and harvest of a crop. The maximum waiting period should be 120 days, with the option for shorter waiting period if steps are taken to prevent or detect contamination of the crop, including the use of hand harvesting.
7. Conservation Measures: FDA should explicitly support important conservation measures, such as planting native plant buffers as bee habitat and using cover crops. Conservation measures support food safety and food security, and it is vital that the agency’s rules not discourage them.
8. Records and Recordkeeping Requirements: I urge the FDA to limit the recordkeeping requirements, particularly for farms that pack or hold produce from other farms, as follows:
* Accept records kept in the ordinary course of business that reflect the immediate buyer and/or seller, such as an invoice;
* Accept paper records, whether typed of handwritten (a requirement that record be kept electronically would be unnecessary, impose undue expense, and discriminate against those farmers who have no or limited access to technology);
* Require that the records be kept for no more than one year.
9. Supplier Verification Program: FDA should remove the supplier verification program from the HARPC rule. At a minimum, FDA should remove the onsite audit requirement from the supplier verification program. The FDA should also remove the provision that qualified farms or facilities provide written assurances that they meet federal requirements. The supplier verification program effectively imposes an entire second layer of regulation on produce farms who are supplying ingredients to wholesalers and processors, an unnecessary burden that is not authorized by FSMA.
10. Environmental and Product Testing: These provisions vastly increase the cost of the proposed rule and will drive many businesses out of business without necessarily improving food safety. FDA should drop these provisions entirely.
11. Definition of retail food establishments that sell direct to consumers: In the final regulations, FDA must clarify that CSAs, roadside stands, farmers markets, and other direct-to-consumer vendors fall under the definition of a “retail food establishment” and are not “facilities” that are subject to the Preventive Controls Rule. Specifically, FDA should issue the separate rulemaking on the retail food establishment clarification immediately, and extend the comment period on the currently proposed rules so that the impact of the proposed rules can be properly understood.
12. Very Small Business: I fully support the definition of “very small business” in the HARPC rule as a business that grosses $1 million or less annually.
[Full name, business name if you have one, city and state]
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