It’s hard to believe, but many of my colleagues and I have now been working on food safety issues for well over four years, at least since the Food Safety Modernization Act (FSMA) began to move through Congress in early 2009. Throughout that time the road has been twisting and bumpy, with victories and losses along the way, but now the moment of truth has arrived. In just a few weeks, on November 15, the Food and Drug Administration (FDA) will close the comment period on proposed new rules that would greatly affect many of the farmers who are doing the right thing. It’s anyone’s guess right now what will finally come out as a result.
When I talk about the “right thing” I really mean that many farmers at PASA and elsewhere have been working to develop balanced systems of production that prioritize health-building practices from the soil up, and short food supply chains that promote transparency by selling to local and regional markets as much as possible. Such strategies are the embodiment of both common sense and current science, since they maximize the health of the whole system while also minimizing risk through reduction of handling, storage, transportation and other factors associated with longer supply chains. The urgent challenge now before us is that the FDA is preparing to implement food safety rules for tomorrow’s farms based on yesterday’s science.
There is so much at stake in this current rulemaking process that I could hardly overstate the case. However, the proper approach for us to take is not one of panic, but of constructive action instead. That has been our goal all along in working with partners across the country through the National Sustainable Agriculture Coalition (NSAC), and it remains the most critical factor as the final weeks of the comment period approach. Our greatest need is for farmers in particular to write informed comments to the FDA that reflect experiences on the farm and in the marketplace, bolstered by a strong commitment to public health and the new science of sustainable systems that is just beginning to emerge.
Here is just a sampling of the issues that will need to be addressed by thoughtful comments to the FDA by the November 15 deadline:
Prevention vs. Reaction – FSMA intended that the FDA would take a more proactive approach to keeping the food supply safe, by working with farmers and processors before problems occur instead of waiting for a crisis. It is important that we support this concept, and point out to the FDA that this is exactly what sustainable farmers have been doing all along. Representatives of industrial agriculture are always quick to suggest that consolidation of agricultural resources and concentration of production are solutions to food safety and security problems. But we know different, and need to vigorously defend the stance that widespread diversification of properly scaled farms serving local and regional markets is the strategy that reduces risk the most by far. In other words, we are in favor of developing risk-based regulations that acknowledge the inherently lower risk of more sustainable production systems.
Farm vs. Facility – There is much confusion in the proposed rules about the definitions of “farm” and “facility,” which is not helped by the fact that the definition of a farm contains the words “a farm is a facility that…” in it, as a result of the Bioterrorism Act of 2002. This is a critical point for several reasons, chief among them being the necessity of facilities to register with the FDA and to potentially be regulated by both the Produce and Preventive Controls sets of rules being developed. There is also the potential for all facilities to have to pay inspection fees in the future. The FDA is asking for comment on the idea that perhaps all farms should register anyway, and we already know there are consumer advocacy organizations out there who favor this approach. We must insist on clear definitions that give plenty of leeway for legitimate farms to conduct farm-like activities, like actually helping each other with hauling and storage of products, without tripping over an unseen and ill-understood wire that makes them facilities.
Exemptions – Much has been said about various exemptions contained in the proposed rules, and many farmers have been lulled into believing the rules will not affect them because they are exempt. It’s just not that simple, which should surprise no one. All of the potential “exemptions” (quotation marks should probably be employed anytime the word is used), are complicated by the requirement that the value of “all food” produced on a farm, including commodities for processing elsewhere, hay and all other products consumed by livestock or humans, is used in calculating exemption status.
This means for instance that even a relatively small conventional farm that is diversifying to serve local markets will quite possibly not qualify for any exemption at all. In the much heralded Tester-Hagan Exemptions contained in the rules, there is also a “material conditions” clause that allows FDA to withdraw an exemption if, in their sole judgment, a risky situation exists on a farm or facility. Also, there is no mention about how, if ever, an exemption can be restored if lost, or to whom such a lost exemption would accrue. And then there are modified requirements applied in the case of most exemptions; hence the necessity of taking all discussion of exempt farms and facilities with a significant grain of salt.
Manure, Water & Wildlife – Once taken for granted that farms were meant to operate in harmony with nature, the industrialization of agriculture has pretty much disabused us of such sentimental notions. The proposed FSMA rules take a very nuanced, but ill-considered approach to the topics of manure, water, wildlife and other environmental concerns that may affect the safety of food.
For instance, applying manure to any field would mean not harvesting a crop from that field for 9 months, and some circumstances could require weekly testing of water sources. Interactions with wildlife are also not adequately dealt with in the rules. In nearly every case the farmer is held responsible to mitigate the potential negative effects of natural systems on food safety, with very little acknowledgement as to how such systems actually can contribute to the safety of food, viability of the farm and quality of the environment. This is one general area where farmers must weigh in with comments based on their personal experience. There is more to be lost here than meets the eye for sure, and we cannot give in to the notion that a safe and abundant food supply is inherently contrary to natural systems.
Where’s the Science? – Throughout the proposed FSMA rules one thing is very clear: the scientific data used to support them is thin at best and absent in many cases. Some of the economic impact projections seem made up to support the cause (and even fail in doing so); the instructions for water testing are based on recreational water standards; manure and compost procedures seem based on irrational fears more than actual science; and the entire process has been totally devoid of any acknowledgement that balanced systems might actually require the infusion of healthy bacteria, as opposed to just the “search and destroy” approach to pathogens.
This strategy is totally unacceptable for a rulemaking process, especially when advances in science are rapidly developing, and an entire revolution in the way we look at health, nutrition and food safety may be in the immediate offing. Farmers, and those who support them, must speak loudly with an insistence on the use of science, on gauging food safety regulations and enforcement based on proven risk, and on using “guidance documents” as opposed to regulations to contain the use of metrics that may change more often than federal rulemaking can reasonably accommodate. Science has always been our friend in the sustainable agriculture community, coupled with the indigenous knowledge and experience of our farmers, and we must now insist that such a dual approach is paramount for success in managing food safety concerns.
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The above areas of concern are only the tip of the iceberg when it comes to understanding and responding to the issues contained in the proposed rules under FSMA. Those working most closely on the rules have, as a group, digested literally thousands of pages of material so that farmers and interested consumers have a fighting chance of being able to weigh in with thoughtful and effective comments themselves. Expressions of frustration and fear sent to FDA may affect the process to some extent, but will not be nearly as helpful as the comments that come from experience and at least cursory research on the relevant issues.
To that end, members and staff of NSAC have developed a FSMA Action Center with abundant (though abbreviated) information and clear instructions on how to make public comment, which can be accessed at http://sustainableagriculture.net/fsma/. You can also access more information elsewhere on this blog, http://writetofarm.com, including several articles on FSMA and sustainable agriculture perspectives on food safety.
Both of these websites offer a chance to sign up for updates, and both would be good to share with your family, friends, customers and other associates, so they may participate as well. The important thing is to make comments early and often to FDA, on either or both rules as necessary, by the deadline of November 15, 2013. The future of our farms and food systems may depend on your informed and focused efforts right now!