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?
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.
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 And they have established a process to regain a qualified status that has been withdrawn.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.
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.
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.
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.
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.
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.
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.
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.
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