On-Farm Produce Safety Standards Rule FDA FSMA on-Farm Produce Safety Standards Rule Click here to download rules For farmers who don’t qualify for the Tester-Hagan exemption or whose exemption is revoked, the proposed produce safety rules cover every aspect of growing and harvesting crops, including worker training, hygiene, domestic livestock, wildlife, and buildings and equipment. There are three problems that underlie almost all of the provisions: The agency has failed to provide a sound scientific basis for many of the requirements, choosing instead to take an extremely risk-averse approach. Farmers are allowed to establish alternatives for some of the requirements, such as those dealing with biological soil amendments and water, but only after going through the expense of conducting or finding research and testing. In other words, in many cases, the farmers must do the FDA’s job in order to continue using farming methods that have been used for decades or even centuries. All of these provisions carry record keeping requirements. The sheer volume of records that will need to be maintained will swamp many small and mid-size farmers. Such farmers do not have administrative staff to handle paperwork, nor do they have the time to manage extensive paperwork in addition to the long hours involved in farming. The proposed rules repeatedly use phrases such as “appropriate measures,” “minimize the risk,” “periodically,” and “reason to believe.” These terms are ambiguous. In practice, farmers will be subject to fines if a field inspector has a different interpretation, even if that farmer has taken good faith steps to comply with the law. Thus, the proposed rule creates significant uncertainty and risk for producers. Substantively, two sections of the proposed rule appear to pose the greatest problems for farmers: the requirements relating to biological soil amendments and water. The section on domestic livestock and wildlife also has significant potential to cause problems for diversified and sustainable farmers. Biological soil amendments biological-soil-amendmentThe proposed regulation on biological soil amendments poses one of the greatest threats to sustainable producers. The use of a wide range of biological soil amendments, from manure to different types of compost, is integral to raising produce with chemical-free methods. While producers in some parts of the country have reasonable access to vegetation-based composts (which will not be strictly regulated under the proposed rules), animal-product-based composts are the primary option for sustainable producers in large parts of the country. In the preamble to the proposed rule, the agency recognizes that the risk of pathogens may be different in a diversified system with competitive microflora, as compared to a chemical system with little diversity. The agency’s proposed rule, however, entirely fails to take this fact into account and views all microbiology as a risk. Even fully treated compost requires a 45-day waiting period between application and harvest. For untreated compost (raw manure or partially composted materials), the FDA requires a 9-month waiting period between application and harvest. This significantly limits, if not destroys, farmers’ ability to use manure as part of growing crops. Yet manure is a proven low-risk fertilizer on organic farms. USDA’s regulations for certified organic producers allow farms to use raw manure for fertilizer if it is applied three to four months prior to crop harvest (depending on the method of application), and there have been no reported outbreaks due to this practice, to our knowledge. In addition, FDA’s proposed rule treats all of the following soil amendments as if they were raw manure: Compost made without specific heating periods (farmers often refer to this as “static composting,” but the FDA has defined that term differently); Vermicompost or worm castings; Compost teas with any additives, even simple molasses or kelp meal; Any compost that does not meet the precise methods and testing requirements specified in the rule. The practical effect of the proposed rule is to allow synthetic chemicals to be easily used, while making the use of many natural soil amendments difficult or even impossible for many farmers. Water requirements farm-barn-waterFDA considers water to be “agricultural water” if it is intended to or likely to contact produce or food-contact surfaces. This includes water that is directly applied to the harvestable portion of a crop, water used for preparing crop sprays, and water used for washing or cooling harvested produce. Generally, the proposed agricultural water standards require farmers to ensure that agricultural water is “safe” and “of adequate sanitary quality for its intended use.” A farmer would not be required to test his/her agricultural water if he or she: Uses water from public water systems and has public water system results or certificates of compliance; or Treats the water according to the water treatment requirements (see below). Otherwise, farmers are required to test any agricultural water they use. FDA is proposing standards based on testing for generic E. coli. Generic E. coli is not a pathogen or disease-causing organism, but is considered a proxy for fecal contamination. FDA is proposing two numerical standards for testing: No detectible E. coli present per 100 ml of water: This standard would apply to water used for an activity during and after harvest, water used to make agricultural teas, and water used in sprout irrigation. No more than 235 colony forming units (CFUs) generic E. coli per 100 ml for a single water sample, and a rolling geometric mean of five samples of no more than 126 CFU per 100 ml: This standard would apply to water used for growing activities that directly contact the harvestable portion of the crop. The frequency of testing would be based on the source of the water. The most stringent testing frequencies apply to untreated surface water: If the untreated surface water is from a source where a “significant quantity of runoff” is likely to drain into it (e.g., a river or lake), then a farmer must test the water at least every seven days during the growing season. If the untreated surface water is from a source where underground aquifer water is transferred to a surface water containment in a way that minimizes runoff drainage into the containment (e.g., on-farm constructed water reservoir), then a farmer must test the water at least once each month during the growing season. For areas such as Texas and the south, the growing season can extend throughout the year, requiring 52 water tests each year if surface water is used. Since the testing must be done at an approved lab, the cost of the test would be increased by the expense and inconvenience of shipping the samples or driving significant distances each week to take the samples to the nearest accredited lab. The cost of such testing would be several thousand dollars per year for each water source used. It would be logical to allow the frequency of testing to be reduced if the water source consistently meets the standards during some initial period of time. Yet the proposed rules make no such provision, requiring weekly testing forever, with no end, for surface water. For other water sources, such as ground water, FDA is proposing that farmers test at the beginning of each growing season, and every three months thereafter during the growing season. The proposed rules require that the farmer “immediately discontinue” the use of a source of water if it does not meet the tests for generic E. coli. If the problem cannot be addressed through changes to the water system, the farmer would be required to treat the water with an antimicrobial compound. Any chemical used to treat water would need to be registered with the Environmental Protection Agency and – as FDA acknowledges – no chemicals have been approved for such use! FDA assumes that this issue will be addressed and a new registered product created before farmers must comply with the water standards. If not, farmers would be forced to either stop irrigating or find alternative water sources (which may or may not be possible). In addition, the proposed standards require a farmer to inspect his/her agricultural water system at the beginning of a growing season. In that inspection, a farmer must identify conditions that may result in hazards contaminating produce through water, and take into consideration: The nature of each agricultural water source (e.g., ground water or surface water); The extent of the farmer’s control over each source; The degree of protection of each source; Use of adjacent or nearby land; and The likelihood of hazards being introduced in the water by a farm upstream. Domestic livestock and wildlife livestock-lambThe standards for domestic and wild animals provide extreme discretion to FDA inspectors and officials, and leave farmers largely guessing as to what they have to do to comply. For example, if there is a reasonable probability that domesticated animals that graze in fields will contaminate covered produce, then the proposed standards require an “adequate waiting period” between grazing and harvest. The regulations do not specify a length of time that FDA considers an adequate waiting period, but the preamble to the regulations states that FDA “would not expect” the waiting period to exceed nine months; this is the same interval that FDA proposes between the application of raw manure and harvest, and it effectively forces a farmer to abandon using that section of his property for the growing season. Yet the FDA gives no guidance as to what shorter period may be acceptable. Similarly, if there is a reasonable probability that working animals will contaminate covered produce, then FDA requires a farmer to take “measures” to prevent the introduction of foreseeable hazards such as animal feces, but the agency does not specify what those measures would be. The FDA is clearly trying to avoid the criticisms that have been leveled at the Leafy Green Marketing Agreement. In the preamble, the agency states that it does “not intend for proposed §112.11 to suggest that you would need to take measures to exclude animals from outdoor growing areas, to destroy animal habitats near your outdoor growing areas, to clear farm borders around outdoor growing areas or drainages, or to take any action that would violate applicable environmental laws or regulations.” Yet nowhere does FDA explain what measures the farmers should take to meet the vague standards in the proposed rule, and it would be difficult to comply with a strict interpretation of those standards without taking at least some such measures. Among other issues, the rules fail to recognize a critical distinction between machine harvesting crops and hand harvesting them. A machine cannot discriminate between a live animal, animal feces, and a vegetable plant; as a result, the presence of livestock or wildlife on large-scale farms that use machine harvesting poses a significantly different level of risk than on a small-scale farm that uses hand labor. Combined with the proposed rule on animal-based soil amendments, this section poses significant problems for diversified farms that integrate produce and animal production, a key part of which is adding animal excreta to the soil. These diversified farms are efficient, both biologically and economically, yet they would be hard-pressed to comply with the proposed rules. Even ignoring the out-of-pocket expense, many of their methods simply could not be brought into compliance. These farms have not been shown to pose a high risk of foodborne illnesses in practice, and they are being penalized based on fear-based assumptions rather than data. Until the 1950s, most farms in the U.S. were diversified small farms that had both livestock and crop production. Yet the agency ignores the proven track record of this type of farming, creating damaging limitations on the presence of both domestic livestock and wildlife on the farm. Overstating the benefits FDA estimated that the benefits from the produce safety rule would be over $1 billion. In making this claim, however, the FDA significantly overestimated the number of foodborne illnesses attributed to produce. The FDA relied heavily on a single study that developed a multiplier to try to account for the number of foodborne illnesses that occur each year but are not reported. Yet FDA then used that multiplier in a way that was inconsistent with the study, further inflating the estimates. It is important to recognize how speculative all of these multipliers are. In the time period examined by FDA, there were only 4,293 illnesses actually reported from raw produce other than sprouts. FDA’s series of assumptions led to an estimate of 2,314,715 illnesses from such products. In other words, FDA estimated that there were more than five hundred times as many unreported illnesses as there are reported illnesses. Only with this extreme guesswork was FDA able to claim significant benefits from the proposed rule. The costs would destroy many farms family-farmIn contrast to the speculative and overstated benefits from the proposed rule, FDA’s estimates of the costs are extremely conservative, and yet still very concerning. According to FDA’s own analysis, the annual costs of compliance would be: $4,697 for very small farms (average annual food sales under $250,000) $12,972 for small farms (average annual food sales under $500,000) $30,566 for large farms (average annual food sales over $500,000) The actual costs are likely to be much greater, as explained next. The FDA severely underestimates the costs of the rule by assuming that small and very small farms (under $500,000 per year) only operate for 3 months per year, and only harvest, pack, or hold produce for 45 days out of the year; the agency estimates that large farms (over $500,000 per year) operate only 6 months per year and harvest, pack, or hold produce only 90 days. This is simply false for many farms in many parts of the country. With respect to the costs of the new limitations on the use of manure, compost teas, and composts, the FDA assumes that the cost is nothing more than switching to purchasing treated compost, since that is the “minimum cost alternative.” Yet what if the treated compost that is available in the area is of poor quality? What if the farmer uses compost teas for foliar applications, which is impossible to do with compost? The costs that are imposed by the restrictions on biological soil amendments are far more complex and far-reaching than is reflected by FDA’s analysis. With respect to the provisions for agricultural water, the FDA’s cost estimates appear to be based on wishful thinking. There are no antimicrobials currently approved for treating agricultural water, which means it would be impossible for farmers to treat their irrigation water currently in a way that complies with the regulations. The FDA is simply assuming that there will be treatment options developed and approved by EPA before the rules go into effect. If not, the FDA acknowledges that farmers who rely on water that does not meet the standards will have to stop irrigating or buy water from public water supplies, although the agency’s cost estimates do not address the high cost of these outcomes. FDA’s over-estimate of the benefits and under-estimate of the costs of the proposed rules means that the costs of the rule will exceed any benefits. Moreover, there will be significant indirect costs, in the form of discouraging new farmers, as well as favoring chemical methods of agriculture over sustainable methods. The restrictions on biological soil amendments, alone, could force sustainable farmers who are not protected by the Tester-Hagan exemption to switch to chemicals or go out of business. Preventative Controls and the HARPC Rule Click here to download the FDA document Click here to download rules As with the produce safety rule, producers who sell less than $500,000 of food annually and who sell more than half of that directly to consumers or local restaurants and retailers are exempt from the Preventative Controls requirements under the Tester-Hagan amendment. Even under the Tester-Hagan exemption, though, processors will still have to register with the FDA (which was required even before FSMA, under the 2002 Bioterrorism Act), and provide documentation that they are complying with any applicable state and local laws. The documentation could be as simple as sending in a copy of one’s commercial kitchen license or mobile food vending permit. In addition, “retail food establishments,” defined as businesses that sell 100% directly to consumers, are also exempt. The FDA is proposing an additional exemption for “very small businesses,” and is considering three possible definitions of this term: gross annual sales of under $250,000, under $500,000, or under $1 million. For processors who don’t qualify for the exemption or whose exemption is revoked, the Preventative Controls rule requires that any business that packs, holds, processes, or manufactures food creates a hazard analysis and risk-based preventative control (HARPC) plan. homemade-picklesThis encompasses a large number of low-risk activities that farms, food hubs, and cooperative produce distributors normally conduct, such as packing fruits and vegetables, milling grains, and making maple or sorghum syrups. A few, very limited on-farm post-harvest activities are exempt, but only on the farm’s own produce. All of the following would be subject to the HARPC requirements: Two farms running a joint CSA and handling each other’s produce; A farm that stores food from any other farm or producer (even if they do no processing); and All sorts of “food hubs” that distribute food from multiple local producers. In effect, FDA treats a legal event—the change in the possession of a crop—as a safety hazard, despite all scientific evidence to the contrary. In addition, even many low-risk activities conducted by a farm on its own produce would be subject to the rule, such as dehydrating fruits and vegetables or making jam. A business subject to the Preventive Controls rule must conduct a “hazard analysis” of all its operations to identify potential food safety threats and steps to control them. The plan must incorporate: Hazard analysis of potential risks that could affect food safety; Science-based preventive controls designed to prevent or mitigate identified hazards; Monitoring procedures; Corrective actions to address a problem when discovered; Verification annually that the plan is working as intended; and Recordkeeping of monitoring procedures. Estimates of the costs of such plans indicate that they can cost thousands of dollars, up to $20,000, for a small operation in the first year. The rule then requires annual “verification” that the plan is working, with records of this verification process and its findings. The scope and complexity of the paperwork that will be required is daunting for both on-farm and off-farm processors. In the early 1990s, similar HACCP requirements led to many small- and mid-scale slaughterhouses having to shut their doors. The FDA’s proposed rule has the potential to put an end to many of the exciting innovations taking place right now with local food hubs, community processing facilities, and the other infrastructure so vital to re-establishing local food systems. An additional concern is that the proposed rule references “supplier verification” as an element of a food safety program. Given how some state regulations have already been applied, this could mean that a regulated facility would not be able to purchase food or ingredients from farms and facilities that are exempt from some federal regulations (such as those protected by the Tester-Hagan exemption). Thus, for example, a food hub with gross sales of more than $1 million might find itself unable to source produce from small, local farms. The Preventative Controls rule does not require this, but it does lay the foundation for such a step.
Posted on: Mon, 04 Nov 2013 13:26:40 +0000
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