FSMA Market Manager Comment Template.docx



Food Safety Modernization ActFarmers Market Manager Commenting Template 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 – Get informed and determine how you may be affected by the rules. Read FMC’s summary of how the rules will impact farmers markets and vendors here. Step 2 – Customize the comment below! There are guiding questions to help you tell your story. These questions are highlighted in yellow. Enter your information, and then remove the yellow highlight. Get additional information about each of the issues here: . Feel free to include in your comment letter whichever issues below are most important to you – all 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 and for mailing a comment, here: (). Step 4 – Spread the word! Ask your vendors, customers, non-profit partners and neighboring farmers markets to submit comments too! Comment templates are available for farmers here and customers here. Please also share this flowchart with direct-marketing farms to help them understand if they will be affected by the rules. 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 Administration5630 Fishers Lane, Rm. 1061Rockville, MD 20582Re: Preventive Controls Rule: FDA-2011-N-0920, Produce Standards Rule: FDA-2011-N-0921 I am a ____ [farmers market manager, board member, volunteer…], at [ XX Farmers Market] in [City], [State]. [Include general information on your market – number and variety of vendors and customers, days open, events offered, when was it founded, etc.]Food safety is of upmost importance to the success of my market. As a direct-marketing operation, our farmers and vendors thrive on the reputation that they cultivate with customers. 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 at the market, regulations you adhere to, etc.], and our vendors [add food safety practices that your farmers and vendors take]. These steps allow us to offer our community fresh, local food, while encouraging and advancing sustainable farming practices. Like many farmers markets across the country, the [name of your market] Farmers Market offers these significant services to our community with limited resources and low overhead. As written, the proposed Food Safety Modernization Act rules will have dramatic negative consequences for my market and the farmers and customers who depend on it. On behalf of my market, I ask that the FDA make the following changes to the proposed rules: Clarify in the Preventive Controls Rule that farmers markets, CSAs, roadside stands, and other direct-to-consumer vendors fall under the definition of a “retail food establishment” and 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. My market currently operates with a budget of [$XX] per year, with X number of paid employees and X volunteers. Our staff is paid [$XX] per hour. If we were subject to the Preventive Controls Rule, the increased costs of compliance would be a substantial burden on our operation. In addition, a farmers market is fundamentally NOT a facility but a retail food establishment where customers can purchase produce directly from farmers. [How would additional registration requirements and fees affect your market? Would you be able to absorb increased compliance costs? Would you have to cut programming, staff, or add additional fundraisers?]. 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. [Do any of your farmers operate on multiple sites? Is it common for your farmers to harvest, pack or hold produce at their farm or off-farm? How about multiple farmers sharing a resource such as a cold storage facility? Tell the FDA about it. How does your market define ‘farm?’]Include a fuller range of low-risk on-farm processing activities in the final Preventive Control 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.Value-added foods such as pickles, baked goods, syrups and oils are big sellers at farmers markets. These goods provide an important revenue stream that has become integral to the livelihood of our farmers. [Include examples from your market – who’s your biggest value-added vendor? What percentage of your vendors offer value-added products? Which value-added products are customer favorites, and what would happen if your market no longer had them available?] FDA’s proposed rules fail to include additional activities that are already considered low-risk by many state Cottage Food laws. These set the standards for safe value-added processing, and the FDA’s new rules should reflect, rather than negate those regulations. [If your state has a Cottage Food law, mention it here. What’s covered in your state’s regulations?]If the Preventive Controls Rule overrides existing Cottage Food laws, small home-based food businesses may face significantly increased regulation when they seek to expand their businesses to meet demand (and potentially move beyond their home-based activities). 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. Specifically: for all coverage determinations, FDA should base thresholds on sales of food actually regulated by the rules: either “covered produce” under the Produce Rule, or “covered human food” under the Preventive Controls rule. 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.[Do you estimate that any of your produce vendors gross more than $500,000 in agricultural products other than produce, such as grains or dairy? What effect would it have on your market if these vendors opted out of selling produce at your market?]Consider that 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 by selling strawberries at a farmers market, their strawberry patch would be subject to the most stringent industrial-scale produce rules, even if they only sell $15,000 worth of strawberries. This would make it prohibitively expensive for them to start such a side venture. Find ways to decrease the costs of compliance with the new rules, especially for small and very small farms. Specifically, FDA should provide flexibility for farms and food businesses by including environmental and product testing in guidance for public comment, not the regulations. 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. USDA estimates that the average net farm income nationally is 10 percent of total sales. This data indicates that farms with less than $250,000 in annual sales will be spending 60 percent of their profits complying with the new rules. As a result of these costs, FDA anticipates that some farmers will go out of business, fewer people will start to farm, and more farmers will have to seek off-farm jobs—all of which will contribute to a stagnation in the growth of sustainable farming and local food initiatives.[How would it affect your market if some farmers and facilities go out of business and fewer people start farming? Do you estimate that any of your produce vendors gross between $25,000 and $250,000? Would any be in risk of going out of business if they needed to spend six percent of their annual gross sales on testing, equipment and other compliance measures?]The estimated costs of compliance to food processors could exceed $28,000 annually. How would that affect the ability of vendors with processed foods to sell at your market? Would they be able to absorb the costs? ]I ask you to ensure that new regulations do not put safe farms out of business. Local food initiatives like farmers markets need to be supported and encouraged. Do not place unnecessary burdens on farmers who are already working against the odds to bring fresh fruits and vegetables to people who need them. Thank you for providing farmers, food businesses, and the public with another opportunity to comment on the proposed rules. Sincerely,[Full name, business name, city and state, email address] ................
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