Food Safety Modernization Act – 2014 REPROPOSAL

Farmers Market Vendor Commenting Guidance

Make Your Voice Heard: Submit a Comment to FDA Today!

Deadline December 15th!

The Food and Drug Administration will accept comments submitted online or through the mail. You can use the sample materials below to get started! It is important to personalize your comment – FDA will read every single submission, and unique comments have the most impact.

Step 1 – Determine how you may be affected by the rules – any farmer who grows fresh produce that is eaten raw, wants to grow such produce, or processes food for people may be affected. Read FMC’s summary of how the rules will impact farmers markets and vendors at

Step 2 – Customize the comment below! There are guiding questions in the highlighted areas to help you tell your story effectively to FDA. Get additional details about each of the issues at . You can pick and choose which issues to include in your letter and comment on. Feel free to include all issues or just a few.

Step 3 – Submit your comment in TWO places – to the Produce Rule () and to the Preventive Controls Rule (). This is important because these issues affect both rules. You can get extra help, along with instructions for using regulations.gov and for mailing a comment, here: ().

Step 4 – Spread the word! Ask your farmer neighbors, customers, and business partners to submit comments too! You can also spread the word by sharing social media posts from FMC’s facebook page or NSAC’s facebook page.

COMMENT TEMPLATE:

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Rm. 1061

Rockville, MD 20582

Re: Preventive Controls Rule: FDA-2011-N-0920, Produce Standards Rule: FDA-2011-N-0921

I am a ____ [farmer, entrepreneur, processor…]. What is the name and location of your farm/food business? What do you grow or produce? How long have you been in operation? Where do you sell your products and how do you already ensure their safety?]

I am writing because I am concerned about the impact that FDA’s re-proposed FSMA rules will have on [my farm / business operation, my direct-to-consumer sales, the practices I use on my farm, other farmers in my community, the farms that I buy food from, etc… If you commented on the first draft, say so!]. Our short supply chain—straight from farmer to consumer—reduces risks, and eases traceability. To ensure food safety, we [outline your current food safety practices, regulations you adhere to, etc.].

I ask you to ensure that new regulations do not put safe farms and processors out of business, harm farmers’ soil, water, and wildlife conservation efforts, or shut down the growth of local and regional healthy food systems!

As written, the proposed Food Safety Modernization Act rules may have dramatic negative consequences for my business and the direct-marketing outlets I sell at. On behalf of [farm/business name] I ask that the FDA make the following changes to the proposed rules:

Comments Specific to the Proposed Preventive Controls Rule:

  1. Clarify that farmers markets, Community Supported Agriculture farms (CSAs), roadside stands, and other direct-to-consumer vendors fall under the definition of a “retail food establishment”, are not facilities that must register with FDA and, therefore, are not subject to the Preventive Controls Rule. Without this clarification, farmers markets and direct-to-consumer farms that do light processing activities could be subject to inappropriate, excessive regulations designed for industrial food facilities.

Help FDA understand why this matters: if you operate a CSA, farmers market, or farm stand, you need to comment on this issue!

  • Do you sell food as part of a CSA, farmers market, or other direct-to-consumer outlet?
  • Do you do minimal processing or have off-site drop off locations? What measures do you already take to ensure the safety of this food?
  • How might being subject to additional regulation and fees as a facility impact your operation?Would you be able to absorb increased compliance costs?
  1. Include a fuller range of low-risk on-farm processing activities in the final Preventive Control regulations. Farmers adding value to their crops through low-risk on-farm processing should not be subject to the same regulations as high-risk processors. The Preventive Controls Rule includes a good initial list of low-risk processing activities done on-farm, but fails to include additional activities that are already considered low-risk by many states. Existing state Cottage Food laws set the standards for safe value-added processing, and the FDA’s new regulations should reflect, rather than negate those regulations.
    Low-risk activities should include:

●Acidifying, pickling, and fermenting low-acid fruits and vegetables made in compliance with existing Good Manufacturing Practices

●Baking activities involving grain products

●Roasting grains for animal feed

●Extracting oils from seeds

●Extracting virgin olive oil

●Making molasses from sugarcane and sugar beets

●Making syrups from sorghum, rice, and malted barley

Help FDA understand why this matters:

  • What percentage of your sales are value-added products? What percentage are direct-to-consumer?
  • Do you process your own fresh produce using any of the low-risk methods below? If so, which ones?
  • Are there processing activities already regulated at the state or county level for food safety?
  • If the Preventive Controls Rule overrode existing state or county regulations, how would the additional regulation impact your business?
  1. Remove the onsite audit requirement from the supplier verification program and remove this program from the Preventive Controls rules. 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. Supplier audits are an increasingly common practice in the marketplace for farms looking to access wholesale markets. However, in FSMA, Congress explicitly prohibited FDA from requiring third parties to verify or audit compliance with the rules.

FDA must follow the law and remove the onsite audit requirement from the supplier verification program. FDA should also remove the supplier verification program from the Preventive Controls rules. FDA must ensure flexibility for farms and food businesses, and that produce farms subject to the Produce Rule are not subject to multiple and duplicative compliance requirements.
Help FDA understand why this matters: if you are a small processor, or you sell raw produce to processors or wholesalers – and/or if are already GAP-certified – you need to comment on this issue!

  • Do you already sell produce to wholesalers or facilities?
  • If so, do they already require an audit or something other certification scheme?
  • If not, does the cost of acquiring such a certification prevent you from accessing those markets?
  • Have you otherwise voluntarily obtained market certification (e.g. 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?
  1. Decrease the cost of compliance with the new rules, especially for small and very small farms.FDA’s own analysis of the cost of implementing the new rules found that very small farms (with annual sales of $25,000-$250,000) will spend six percent of their annual gross sales on testing, equipment and other compliance measures. As a result of the high costs of compliance, FDA anticipates 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. FDA should specifically provide flexibility for farms and food businesses by including environmental and product testing in guidance for public comment, not the regulations.
    Help FDA understand why this matters: if you process fresh produce for sale or sell raw produce to a facility, you need to comment on this issue!
  • Processors: How will costs of compliance that could exceed $28,000 annually impact your operation? Will you be able to absorb these costs?
  • 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?
  • If you are a farm that does on-farm processing, will you have compliance costs from both the Produce Rule and Preventive Controls Rule?
  • 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.

Comments Covering Both the Reproposed Produce Rule and the Reproposed Preventive Controls Rule:

  1. Clarify the difference between a farm and a facility using common sense and risk-based distinctions that have clear connections to promoting food safety. Specifically: (1) The FDA should clarify the “farm” definition to ensure that farmer-operated businesses that engage in “farm” activities—growing, harvesting, packing, or holding raw agricultural commodities—are considered farms. (2) FDA should remove the phrase “in one general physical location” from the farm definition, to reflect the modern-day reality that farms are not always contiguous, and that farms may include structures in different locations or on different parcels of land

Help FDA understand why this matters: if you are part of a food hub, multi-farm CSA, or any other shared farm produce aggregation efforts (including co-ops), you need to comment on this issue!

  • Is your farm made up of a single parcel, or multiple parcels? Are they contiguous or not?
  • Do you have packinghouse or other farm structures located on different parcels of land?
  • Do you aggregate agricultural products at a food hub? If yes, are you a farmer and partial (or sole) owner of the food hub? Is the food hub located on your farm, on another farm, or elsewhere?
  • Do you cooperatively own any of your farm buildings, including a food hub or pack house? If yes, is it located on your farm or someone else’s?
  • How do you manage risks in your separate farm buildings?
  • If you pack and hold agricultural products on your farm and off your farm, do you treat the activity differently? Do you think they pose different risks or the same risks?
  1. Base all calculations used to determine whether and to what extent a farm or food business is covered under the rules on sales of what the rules regulate. 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 (A farm or food business could be subject to the full rule; the full rule but with extended compliance timelines; modified requirements; or be 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. However, none of these calculations are based on sales of what the rule actually regulates. This lack of clarity and consistency across the rules will only further confuse implementation and compliance for two already-confusing rules.

For all coverage determinations, FDA should base thresholds on sales on food actually regulated by the rules: either “covered produce” under the Produce Rule, or “covered human food” under the Preventive Controls rule
Help FDA understand why this matters: if you grow both COVERED produce and NON-COVERED produce or are otherwise diversified or integrated (dairy, grain, livestock, etc) you need to comment on this section!Remember, If a farmer has over $500,000 in sales of produce that isn’t covered by the Produce Rule – like winter squash, pumpkins, and root vegetables like turnips – and wants to diversify with a small u-pick strawberry patch, that patch would be subject to the most stringent industrial-scale produce rules, even if they only sell $15,000 worth of strawberries, which would make it prohibitively expensive for them to start such a side venture.

  • Do you have a variety of income streams from farming? What are they?
  • Do you grow a mix of produce that would be covered under the Produce Rule and produce that wouldn’t? 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”?
  • Are you an on-farm processor or food hub? Do you gross more than $1,000,000 in food sales (including processed foods, produce, grain, dairy, etc)? How much of that is in sales of processed foods versus other types of foods?
  • Are you interested in diversifying into produce usually consumed raw? How would meeting the full Produce Rule standards for this produce affect your ability to diversify?
  1. Make the exemption withdrawal process consistent between the Produce and Preventive Controls Rules, and clearly state the individualized nature of a withdrawal determination in the withdrawal notice or order. FDA has broad authority to take away the qualified exemptions (modified requirements) certain farmers and facilities are eligible for and subject them to the full weight of the regulations if they think there is a food safety problem on the farm. The revised rules include a way for farmers and food businesses to regain their qualified exempt status if it has been taken away. However,FDA should still ensure that both rules follow a clear and consistent process. It should also include – in both the initial notice of intent to withdraw and the withdrawal order itself – facts specific to the business that holds the qualified exemption, to ensure that each withdrawal is made on an individualized basis and that the farmer or facility has a meaningful opportunity to rectify the situation.
    Help FDA understand why this matters: if you are a farmer or food business who may be eligible for an exemption or modified rule requirements as a direct marketer, you need to comment on this issue!
  • Do you think the circumstances under which FDA can take away your exempt status are clear? Does the process seem reasonable and fair?
  • What type of facts should FDA include in an initial notice of intent to withdraw an exemption? What type of evidence of a problem should FDA include in a withdrawal order?
  • What type of documentation do you regularly keep that could be used to appeal a withdrawal order?
  • Should produce farmers have 60 or 120 days to come into compliance with the full Produce Rule if their exemption is taken away?
  • Do you support FDA’s decision to allow you to regain your exempt status in case it is withdrawn?

Comments Specific to the Proposed Produce Rule:

  1. Take a science- and risk-based approach to agricultural water that provides clarity and flexibility to allow farmers to respond to specific risks in their water systems, and defer finalizing a numeric water quality standard until a full risk assessment is completed. The Produce Rule includes costly, unscientific standards for irrigation water – including water testing and treatment requirements. Any numeric water quality standard should be in guidance, not regulations, to provide an ongoing mechanism to adjust the standard to reflect new science.

Additionally:

  • FDA should reduce the frequency of testing. As currently proposed, the testing frequencies are overly burdensome, lack scientific justification, and will impose great costs on farmers to repeatedly test the quality of water that will remain impaired for reasons beyond their control.
  • For water sources that are outside the farmer’s control and consistently exceed the standard, or water sources that are controlled and consistently satisfy the standard, FDA should provide the farmer with the flexibility to determine the number of tests needed to establish a baseline and characterize the water quality profile of the source.
  • FDA should align with the USDA GAPs standard, and limit testing frequencies to three samples per growing season.

Help FDA understand why this matters: If you irrigate on your farm in any way, you need to comment on this issue!