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Top 10 Fixes and Fails in FDA’s Revised Draft Food Safety Rules

November 12, 2014


Around this time last year, we published a list of the Top 10 reasons for farmers, consumers, and organizations to weigh in on FDA’s proposed food safety rules.  Since then, FDA has released its revised approach on several key issues in the proposed rules – essentially a second draft – and is giving farmers, consumers, and the organizations that work with them a second opportunity to weigh in.

Based on our analysis of the revised proposed rules, it’s clear that FDA heard us last year; these revised rules contain many positive changes to address the impact these new food safety rules will have on sustainable food and farms.  But they didn’t fix everything.

Here we’re revisiting last year’s big issues (in no particular order) and looking at how they fare the second time around.  Did FDA fix the issues like farmers, eaters, and others in the sustainable agriculture community recommended?  Or did they fail, which means there’s more work to be done?

FSMA Top 10 Graphic

1. They’re too expensive.  The rules could make it harder for small and mid-sized farms and food businesses to make a profit, and could keep beginners from starting to farm.

FAIL – FDA has added additional expensive requirements – like increased testing and verification measures – that will increase costs for food businesses, farmers, and ultimately consumers.

As a result of the high costs of compliance for both the Produce and Preventive Controls Rules, 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 to keep farming.  Costs will be significant for farmers of all sizes but most acutely felt by small and mid-size growers – FDA’s numbers show that growers with sales up to $500,000 will spend 4-6% of their gross revenue to comply with proposed on-farm regulations.  The average net income for farmers nationally was 10% of sales in 2011;  so for small farms subject to the rules, FSMA could consume more than half of those modest profits.  These figures are essentially unchanged by the revised language.   Learn more about the costs of compliance issue under the Produce Rule and Preventive Controls Rule.

2. They treat farmers unfairly.

FIX – FDA’s initial proposed rules raised serious concerns that FDA could take away the modified requirements that certain farms and food businesses selling directly to consumers were eligible for, and subject them to the full weight of the regulations, without notice or an opportunity to respond to the situation, and without a way to regain a qualified status once revoked.  The proposed rules now specify actions FDA must take before withdrawing a farmer’s qualified exemption, as well as alternative actions FDA may take before turning to withdrawal.  And they have established a process to regain a qualified status that has been withdrawn.

FAIL – The process is not consistent across the rules, and FDA still has not defined key terms (like what it means for conduct or conditions to be “material” to food safety), which makes FDA’s enforcement of this provision unclear.  Learn more about the modified requirements and the process for withdrawing and reinstating a qualified exemption in the Produce Rule and Preventive Controls Rule.

3. They will reduce access to fresh, healthy food.  Local food distributors like food hubs could close, and new food businesses would not launch.

FIX – FDA’s original proposed definition of “farm” failed to capture the reality of what farms do, and risked inappropriately regulating farms as food facilities.  FDA has improved the definition of “farm” to recognize the common practice of farms packing and holding products from other farms, and has added some needed clarity to activities that are considered farming, packing, or holding activities.

FAIL – The farm definition is still inaccurate and fails to capture additional realities of modern-day farming (like farms spread across multiple parcels of land, or jointly controlled packing operations), which could subject farmers to unnecessary and burdensome regulations designed for large food facilities.  This could make it significantly harder for farmers – especially farmers working together through innovative efforts like cooperative packing and holding – to get fresh produce into local schools, hospitals, grocery stores, and markets, undermining important public health goals.  Learn more about the “farm” versus “facility” issue.

4. They make it harder for farms to diversify.

In both proposed 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 scale and other factors, 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.  If FDA’s definitions are not clear and reasonable, start-up operations – like a farmer making jam from her fruit, a food hub helping get healthy local food into schools, or a mid-sized grain or dairy farmer looking to diversify into fresh fruits and vegetables – could be regulated well beyond their risk, and with compliance costs too high for them to stay in business.

FIX – FDA has made some improvements to the way it determines who is covered by the rules, and to what extent, by changing some eligibility thresholds to be based on calculations of produce sales (under the Produce Rule) and human food (under the Preventive Controls Rule). “All produce” is an improvement from “all food” but it still will be hard for mid-sized farmers to diversify into fresh produce without excessive regulation.

FAIL – FDA still fails to make coverage determinations 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.   Learn more about the all food vs. covered food issue.

5. They will over-regulate local food. The rules could consider farmers markets, roadside stands, and community-supported agriculture programs “manufacturing facilities” subject to additional regulation.

FAIL – Congress clearly instructed FDA to clarify that Community Supported Agriculture (CSAs), farmers markets, and other direct-to-consumer businesses are not facilities subject to heavy regulation under the Preventive Controls Rule, and FDA continues to drag its feet in doing so.  FDA’s failure to provide clarification on this topic causes instability in the local food sector because the impacts of these rules on direct-to-consumer businesses remain unknown, particularly whether these farm-based businesses could be subject to substantial and costly additional regulations as facilities.  Learn more about the direct-to-consumer marketing issue in the Preventive Controls Rule.

6. They treat pickles like a dangerous substance by not protecting low-risk processing activities done by smaller farms and processors.

UNKNOWN – When Congress passed FSMA, it explicitly recognized that farmers adding value to their crops through low-risk value-added processing should not be subject to the same regulations as high-risk processing activities by large corporations.  The original proposed Preventive Controls Rule included a good initial list of such low-risk processing activities, but FDA failed to include additional activities like making pickles and salsa that are already considered low-risk by many states.  FDA did not address this issue in the reproposal, so we don’t know if they plan to fix the issue or not.

7. They make it nearly impossible to use natural fertilizers like manure or compost and conflict with the National Organic Program standards.  Farmers will be pushed to use chemicals instead of natural fertilizers.

FIX – FDA aligned the compost application interval with National Organic Program (NOP) standards, and they are taking a science- and risk-based approach to understanding and regulating raw manure, rather than finalizing the originally proposed interval that would have conflicted with NOP standards and made it effectively impossible for farmers to use manure.

FAIL – Despite aligning the compost interval with the NOP standard, the revised rule still retains some unscientific requirements for what is considered acceptable compost processes, which could make it harder for farmers to use compost on their farms.  Learn more about the manure and compost issue in the Produce Rule.

8. They require excessive water testing on farms.

FAIL – The water standard is still based on an inappropriate recreational water quality standard and requires excessive testing frequencies that are costly and unnecessary.  Learn more about the agricultural water issue in the Produce Rule.

9. They could harm wildlife and degrade our soil and water.

FIX – FDA has clarified that the rules do not require farmers to harm endangered species, exclude animals from outdoor growing areas, destroy animal habitat, or otherwise clear farm borders.

FAIL – This language still doesn’t go far enough to encourage sustainable conservation practices that enhance food safety.  Learn more about FSMA’s impact on conservation measures.

10. Bonus: there’s still time to turn these FAILS into FIXES!

The public comment period on FSMA is open until December 15! We still have time to tell FDA why these issues are so important and fix the problems before the rules are finalized.

We’ve developed materials to help farmers, food businesses, and consumers get informed and take action today:


Categories: Food Safety


12 responses to “Top 10 Fixes and Fails in FDA’s Revised Draft Food Safety Rules”

  1. […] learned a bit about the potential issues from the National Sustainable Agriculture Coalition, which has analyzed the draft rules. After […]

  2. Suzanne Zipperer says:

    As a small farmer, I am concerned about further inhibiting my production and expansion with more food safety regulations. I take food safety very seriously and accept the liability for my product. The statistics show that food related illnesses come from farms infrequently. People should be more concerned with washing their hands after going to the toilet – a practice that seems to be going out of fashion. We do not need stricter regulations. Let us handle this locally.

    I also wonder why there is so much concern for safe food handling by US farmers and so little attention paid to food imports. You do not even require Country of Origin on food products. Just because that spice packet mixed in China is dried and cannot spoil, does not mean it is safe.

    Food safety lies in keeping chemical pesticides and antibiotics out of our food system. Yet repeatedly these things are left to slide.

    Go back to the drawing board with these regulations.

    Suzanne Zipperer
    Manitowoc Wisconsin

  3. Dave Fisher says:

    I am a small scale farmer and food processor and some of these proposed regulations will cripple the local producers and unbalance the market even more so than it already is.
    It is my belief that it is our right to grow and sale our own food. My standers are much higher than alot of these so called regulations for public safety it seems to me this is a ploy to benefit profit margins of large faceless AG conglomerates huge chemical and gmo seed producers. The bottom line is being threatened by the move to local foods.
    If we are forced out of the market thru regulations the consumer will have no options.Capitalism and free trade is based on offering superior products and letting the consumers decide who succeeds or fails not using lobbyist and legislators to control the market.This has been done in the past just look at Hemp,Electric Cars and Solar Power
    Safety is paramount in all my processing practices not due to some regulation or agency but the sense of pride you get from feeding people and its just good business one bad apple can spoil the whole basket.
    Vegetables ,meats, and fruits produced in a sustainable manner without harmful chemical pesticides and fertilizers non- gmo seeds and preservatives will not make us rich by no means but it will let us make a living.

  4. Jerri Cook says:

    As a small-scale organic producer, I am in favor of reasonable regulations that protect both my consumers and me. I’ve found that most people who are opposed to regulation are opposed to any and all regulation, which is disappointing.

  5. […] and much more. Please get educated, check out the National Sustainable Agriculture Coalition’s list and then take action, go to the FDA website and make your voice […]

  6. Dave Fisher says:

    I think public safety and sustainability are two of the most important things to food producers and farmers.Profit is not what motivates us if so we would not choose farming or processing for a living.However the huge farming business,chemical producers, and GMO seed producers not so much.The movement to more localized food production and processing may be cutting into those profits so Que the lobbyist and legislators.I for one think it is my right to grow and sell food.If the small local farmers are regulated out of the market consumers will have no options but to buy and consume whats on the shelf.

  7. […] addition, the National Sustainable Agriculture Coalition (NSAC) has posted its analysis of “The Top 10 Fixes and Fails in FDA’s Revised Draft Food Safety Rules.” Also, NSAC and others will host a public webinar, “The Food Safety Modernization Act: […]

  8. […] Because of this feedback, the FDA went back to the drawing board and re-drafted these regulations. This is the current situation we all find ourselves in and once again it is time to take action. Some adverse provisions of the two rules were revised or removed completely, illustrating that the FDA listened and responded to some of the concerns of commenters. However, too many of those adverse provisions remain such as definitions of farms vs. facilities that would require many small farms to be regulated out of proportion to their operation’s food safety risk, costly water testing criteria that are not rooted in science, other costly regulatory burdens on the modest profits of small farmers, and lack of clarity about impractical impositions on small processers and farmers’ markets to name a few. If you’re interested, you can read more on what’s been fixed and what is still detrimental to small farms and local food systems in this National Sustainable Agriculture Coalition article on top FSMA fixes and fails. […]

  9. […] Click here for a summary of the top 10 fixes and fails in this update. […]

  10. Joan Ribbons RN says:

    I agree with what a small scale farmer (Dave Fisher) said: “I am a small scale farmer and food processor and some of these proposed regulations will cripple the local producers and unbalance the market even more so than it already is.
    It is my belief that it is our right to grow and sale our own food. My standers are much higher than alot of these so called regulations for public safety it seems to me this is a ploy to benefit profit margins of large faceless AG conglomerates huge chemical and gmo seed producers. The bottom line is being threatened by the move to local foods.
    If we are forced out of the market thru regulations the consumer will have no options.Capitalism and free trade is based on offering superior products and letting the consumers decide who succeeds or fails not using lobbyist and legislators to control the market.This has been done in the past just look at Hemp,Electric Cars and Solar Power
    Safety is paramount in all my processing practices not due to some regulation or agency but the sense of pride you get from feeding people and its just good business one bad apple can spoil the whole basket.
    Vegetables ,meats, and fruits produced in a sustainable manner without harmful chemical pesticides and fertilizers non- gmo seeds and preservatives will not make us rich by no means but it will let us make a living.”
    I grow my own veggies and fruit and trust my local gardeners/farmers to provide me with local, safe and nutritious foods that I don’t grow. As a registered nurse I encourage all pregnant women to eat only organic foods and parents to feed only organic food to their children. This is important to support a healthy life, and a healthy environment.
    I feel that we all can learn to protect out environment when we learn to protect ourselves first. Please read and share this article which sums it all up better than I could: ‘Nutritional Updates for Nurses’ by Patricia Bratianu, RN, PhD, RH-AHG .
    Good health is not an accident, it takes knowledge, so I pass this article on to everyone, especially the FDA who I trust to serve us well.
    Yours, Joan Ribbons, RN and small town Family Farmer

  11. […] National Sustainable Agriculture Coalition has compiled a list of its top 10 concerns and how the revised draft food-safety rules fix and/or fail the situation […]

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