The U.S. Food and Drug Administration’s Proposed Produce Rule is a substantively defective product. It’s not a question of the difficulty and costs of compliance and enforcement or of farm size or a commodity’s inherent safety – although these are important issues. The case I want to present is that FDA made seriously wrong choices on too many issues: irrigation water standards; biological inputs such as compost, radiological and chemical hazards; sprout production and fresh-cut production; epidemiological data and economic analysis. Like other hazardous and defective products, the Proposed Rule should be recalled. Today’s column is about irrigation water. Here is the relevant section of the Proposed Rule for testing water: “Article 112.44 (c) When agricultural water is used during growing activities for covered produce (other than sprouts) using a direct water application method you must test the quality of water in accordance with one of the appropriate analytical methods in subpart N. If you find that there is more than 235 colony forming units (CFU) (or most probable number (MPN), as appropriate) generic E. coli per 100 mL for any single sample or a rolling geometric mean (n=5) of more than 126 CFU (or MPN, as appropriate) per 100 mL of water, you must immediately discontinue use of that source of agricultural water and/or its distribution system for the uses described in this paragraph. Before you may use the water source and/or distribution system again for the uses described in this paragraph, you must either re-inspect the entire agricultural water system under your control, identify any conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food-contact surfaces, make necessary changes, and retest the water to determine if your changes were effective; or treat the water in accordance with the requirements of § 112.43.” I hope that’s clear. Farmers are supposed to be able to follow the Food Safety Modernization Act without being forced to hire consultants or private certifiers. Note that there are precise and enforceable – and, as we shall see, useless – metric standards such as “126 CFU per 100 ml” (in a rolling geometric mean) of generic E. coli. The problem is that the generic E. coli standard is completely uncorrelated with the human pathogens of concern that have caused produce outbreaks and recalls such as E. coli O157:H7 and Salmonella. Worse, it has been shown to be uncorrelated with these human pathogens in actual production of leafy greens and other produce in numerous published studies, including by researchers from USDA and UC Davis, for California production, and by other researchers across the country. The largest data set, however, is from a California fresh-cut processor whom I interviewed as part of writing a comment on the Rule. For more than six years, they have tested about 2 million pounds of produce a week, as well as the farm inputs used to grow those 2 million pounds. They tested both for specific human pathogens, such as Salmonella and O157:H7 E. coli, and for generic E. coli, which is required for members of the California Leafy Green Handlers Marketing Agreement (CA LGMA). Their summary: the generic E. coli standard can be exceeded without human pathogens being present, and it can be met when human pathogens are actually present in high quantities. It is not a useful standard for produce safety. Trevor Suslow, in a Pew Issue Brief (1), described the origins of this standard and accurately predicted its increased use: “A limited, and arguably outdated, set of indicators of fecal contamination has been used by the fresh produce industry to assess the suitability of water used in preharvest crop production up to the point of harvest. Many regional GAP and CSG systems have relatively recently adopted EPA recreational water quality criteria for establishing action thresholds, in the absence of actual risk-based data based on irrigation water…. As internal and external pressure is exerted for national standards, a simple approach has been to adopt these EPA criteria.” The standard the FDA proposes to enforce on farmers, as federal regulation, is derived from a now-superseded U.S. Environmental Protection Agency (EPA) analysis and recommendation to state and tribal health authorities for recreational water. The EPA criteria were developed for a different purpose than produce safety and in a different context. This recommendation, and its successor published in the Congressional Record in November 2012 (2), is designed to prevent an excessive number of gastrointestinal illnesses for swimmers, such as 32 illnesses per thousand persons swimming in an ocean or fresh water body of water. The choice of generic E. coli (one of two standards to be met) is based on the actual correlations between epidemiological data on illnesses after swimming and measured indicator organisms. Generic E. coli  (along with Enterococci) had the most robust correlation with actual GI illnesses for fresh-water recreational use out of all the indicators of (mainly) human fecal contamination that were looked at. Looking at the update 2012 EPA Recreational Water Quality Criteria (3) and consistent with the previous standard: “Viruses are thought to be the etiologic agent responsible for most of the GI illnesses that are contracted in recreational waters impacted by sources of human fecal contamination….” Generic E. coli bacteria are used as an indicator of fecal contamination to correlate with largely viral GI illnesses, not for identifying the bacterial pathogens that have caused most produce outbreaks, serious illnesses or deaths (nor with more serious viral illnesses). The original group to adopt the recreational swimming standard and generic E. coli as the indicator species and metric was the CA LGMA. They had their own reasons and context for this choice. One was that, for all its problems, they found that using other bacterial indicators of  fecal contamination were actually worse standards. Generic E. coli was the best of a bad lot of indicators, for their purposes. To my surprise, I found on interview that there has never been a study of the effectiveness of the LGMA in preventing outbreaks. I suspect the same is true for the related GAPS programs. FDA itself never reported conducting an assessment of the efficacy of any of these programs before adopting their metrics or standards as models. It never even got to the level of evaluating the context, role and effectiveness of the irrigation water standard. It gets a little worse. A USDA team reviewed “Irrigation Waters as a Source of Pathogenic Microorganisms in Produce” in 2011 (4). They found: “Despite the general belief that irrigation water poses a potential source of pathogens in food-borne outbreaks, there are relatively few confirmed cases in the USA.” Most of the surface waters of the United States will fail the generic E. coli standard either persistently, predictably during certain times of the year or intermittently. This is a problem for most farmers who want to irrigate. Due to the peculiarities of the proposed rule, however, farmers using buried drip for irrigation and their own controlled wells as a source of irrigation will have an easier time complying. Commercial bulb onion producers were among the first to comment on the irrigation standards (5). One production and irrigation region in Oregon and Idaho, which produces about 20 percent of U.S. onions, would have to cease onion production under the metrics of this rule (6). The possibility of generic E. coli levels in irrigation water stopping irrigation and therefore killing a crop would prevent farmers from ever receiving a production loan, long before even considering “treating” the water of a 750,000-acre irrigation system. On the other side of the country, in Pennsylvania, an interesting two-year study of smaller farms with multiple types of surface-water sources for irrigation found that many farms would fail the generic E. coli tests, although O157:H7 and Salmonella were not detected and while Salmonella could be found occasionally when irrigation water would have passed the tests. It also showed that how samples were chilled and iced for transport to an accepted laboratory could greatly affect results and, therefore, consequences of the testing (7). The problems with surface-water irrigation, identified in early comments, are one of the two reasons that FDA now has called for a full environmental review (EIS) rather than stating the Proposed Rule is categorically exempt (8). The concern is not with the standards, however. Instead, FDA anticipates that so many farmers will switch to well irrigation, despite the expense, that it may affect the status of fragile aquifers. When the basic standard itself is problematic, all the rest of the regulatory requirements around that standard look very strange. Farmers will have to follow a sampling program that tells them how often they should test using a meaningless standard. They will have to document that they have sampled according to the frequency protocols for the meaningless standard. They will also have to document the results of their useless sampling so they can demonstrate to an inspecting authority that their irrigation water passed the meaningless standard. There are very exact protocols that must be followed. Overall compliance costs (not just for irrigation) are a high percentage of operating profits, but failing the meaningless standards for irrigation could be economically devastating. FDA added an extra (and almost sadistic) twist. Farmers can be faced with an entire crop being lost because they have to stop irrigating when irrigation water fails the standard. They have the option of treating their irrigation water with a chemical to kill pathogens. This chemical must, however, be EPA-approved for treatment of irrigation water. There are no such EPA-approved chemicals. There are no EPA standards for testing chemicals to be used to kill pathogens in irrigation water. EPA has no plans, currently, to develop such a standard. A chemical that can kill human pathogens could also wreak havoc with soil microbial ecosystems, farm by farm, in entire irrigation systems and across the nation. FDA’s solution is to delay implementation of the irrigation-water standard by two years. My conclusion on irrigation-water regulation is that FDA will be bankrupting farmers, driving them out of business, preventing new farmers from entering, and shipping produce production out of the United States, and without enhancing food safety. What we will get, instead, is food-safety theater. References: (1) Trevor V. Suslow. Standards for Irrigation and Foliar Contact Water. Produce Safety Project Issue Brief. An Initiative of the Pew Charitable Trusts at Georgetown University, 2010. (2) Environmental Protection Agency. 2012 Recreational Water Quality Criteria. Federal Register, Vol. 77, No. 230; Thursday, November 29, 2012, Notices (pages 71191-71192). Notice of availability and recommendations. (3) Environmental Protection Agency. Recreational Water Quality Criteria (RWQC). Office of Water 820-F-12-058. 2012. (4) Yakov Pechepsky, et al. Irrigation Waters as a Source of Pathogenic Microorganisms in Produce: A Review. Advances in Agronomy, Vol. 113 pp 73-138. 2011. (5) National Onion Association. Comment from the Dry Onion Industry Regarding FDA’s Proposed Rules… (Docket No. FDA-2011-N-0921). Docket for the Proposed Produce Safety Rule, Comments, May 2013. (6) Sean Ellis. “Water Quality Rules Unleash Flood of Fear: Proposed regulations could bring an end to PNW onion crop.” Capital Press [Agricultural Newspaper]. Updated: Saturday, July 06, 2013, 12:11 AM. (7) Audrey Draper. Microbial survey of Pennsylvania water used for specialty crop irrigation and development of sampling, handling and shipping procedures for surface water testing. MS Thesis, Food Science, Pennsylvania State University. December, 2012. (8) Department of Health and Human Services, Federal Drug Administration. Notice of Intent to Prepare an Environmental Impact Statement for the Proposed Rule, Standards for Growing, Harvesting, Packing and Holding of Produce for Human Consumption. Federal Register, Vol. 78, No. 160. Monday, August 19, 2013 (pages 50358-50359). Proposed Rules.  

  • Michael Bulger

    This piece fails to mention the fact that generic E. Coli testing is very inexpensive and can be done without sending water samples to a lab. You simply place about 100ml of water onto a petri dish with a growth medium (costs less than $5) and wait 24 hours. Then you count the now-colored E. Coli colonies. Since E. Coli is a measure of fecal contamination (poop), a high level of E. Coli colonies indication indicates that there is a greater likelihood that the water contains fecal-borne pathogens.

    Basically, FDA is saying that if the water has to much poop to swim in, then you can’t spray it on food.

  • Hydroman

    How are farmers suppose to treat suspected contaminated water? Chlorination? Yes, chlorination kills the pathogens but think about it. You are then applying chlorine to plants and soils. Soils full of humic acids and other organic material. What happens when you add chlorine to an organic molecule you ask??? You get a chlorinated organic compound which just happens to be carcinogenic. These chlorinated organic molecules are then uptaken by the plants and what do you have??? Does anyone (FDA included since they are making this rule) ever test for these compounds??? NO!!!!! I have taken this issue up with FDA and they choose (Despite glaring scientific proof from scientist at USGS, various univerisities, etc…) to ignore science and proceed.
    The policy makers there at FDA don’t have a clue!!!!

  • Mike_Mychajlonka_PhD

    Certainly, this topic is important and worthy of discussion. However, if you or anyone else is going to state that: ” . . . the generic E. coli standard is completely uncorrelated with the human pathogens of concern,” then I and, I think, others would like to see references to peer-reviewed scientific papers where the data that speak to this point are open for inspection. For example, UC Davis has published some of its data on a website ( and perhaps this is the very source you point to. However, I can find no mention that this work has undergone the scrutiny required of a scientific paper. Indeed, the only paper in your reference list (Item No. 4) is a review and not an original paper. Secondly, I can think of ways to process surface water so that it meets the standard and without the use of harmful sanitizers. Indeed, I think that chemical sanitizers have become something of a knee-jerk response to the issue of microbial contamination of any kind. I believe that better solutions are out there, waiting to be put to use.

  • farmber

    This is an Excellent piece that clearly shows how many of FDA’s proposed metrics are based on incomplete (at best) or highly unsubstantiated science.

    And under FDA’s proposed rules trajectory — this incomplete scientific snapshot will become set in stone as the law of the land — requiring all present and future generations of farmers to comply with expensive and erroneous metrics, even if new research quickly brings contrary information to light.

    Currently, for example, the world of microbiology is being turned on its head with new studies on the healthful benefits of beneficial microbes in the gut biome that may easily have counterparts in crop safety responses to positive interventions in the soil foodweb.

    Since this overextended rule may not be not withdrawn as Daniel Cohen proposes — FDA should receive reams of Comments from a wide group of farmers (and eaters looking to protect our localized food supplies) that the metrics as presented should be Totally Scraped in favor of a GUIDANCES approach (with public comment input) where state-of-the-art scientific advances can be updated as we go along…

    • Michael Bulger

      Actually, what has been very clear throughout the rule-making process has been that FDA is drafting rules that will be very flexible so that new research can be applied to the regulations. FDA officials have not been shy about repeating this point.

      There are opportunities for variances and all farms are welcome to submit research demonstrating the effectiveness of whatever methods they are using to ensure food safety. The rules contain very few “set in stone” parameters, and those that do exist are open to change.

      Finally, the FDA was directed by Congress to write rules, not guidances. But you must remember: most farms will have one type of an exemption or another. So, in practice, these rules will serve only as guidance for the overwhelming majority of fruit and vegetable growers.

      • farmber

        These rules are “flexible” in name only — and only for those who have the muscle to flex them…

        While FDA touts rule flexibility, they also publicly acknowledge the weakness of the questionable metrics they have come up with — and say their hope is this situation will stimulate more viable clarification and research from Others. Cute.

        But their cumbersome variances scenario actually shifts yet another burden onto the backs of the farmers who are least able to navigate the convoluted processes that will actually provide acceptable research to actually change the rules — all the while remaining in compliance with the bad metrics until that actually happens. Big Ag, on the other hand is already well versed at laying down some Land Grant dollars here and there to produce studies saying what they want (like “toxic pesticides are Good for you.”)

        And another problem lurking in the background in this time of extreme budget cuts is that FDA’s capacity — and actual “flexibility” is questionable. Right now they are even way behind in keeping up with the requirement to publicly post the already-submitted Comments, for example, and that’s an easy lift. Having the ability to actually change regulatory language somewhere down the line after these rules are finalized is something else again…

        • Michael Bulger

          “Small Ag” is generally exempt from these rules. In fact, the overwhelming majority of farms will not be required to comply with the requirements. Weakening the draft rules is weakening regulations on the growers who put the most food into commerce and generate the most money in sales.

          • farmber

            But “exempted farms” are still fully subject to FDA oversight and they can have their exemptions quickly removed under FDA’s Withdrawal of Exemptions powers for suspicion (by an inspector quite possibly not familiar with farms and farming) of not complying with the instituted metrics — with no clear path back to reinstatement. In fact, by not having to keep certain records and meet other paperwork requirements, the “exempted” farms may not have the proof FDA requires for reinstatement. All in all a lengthy bureaucratic process and a nightmare for small businesses.

            Guidances are a much more flexible model to match oversight to evolving scientifically-valid metrics.

          • Michael Bulger

            Congress mandated rules, not guidances. But in any case, exempt farms aren’t required to carry out the activities covered farms have to keep records on. So your hypothetical example of an exemption withdrawal doesn’t hold water. Each comment you submit seems to have another example of you misunderstanding FSMA and/or the draft rules.

  • Donna Lynn Browne

    Excellent article and to the point! And Mike B. the tests maybe cheap but when a farmer can no longer use his water source he is out of business , period. The science is there and we need to use it! not try to placate people who just want to ‘feel’ good by installing guess work standards. Believe me you the FDA will be getting comments from me! That said, I think the FDA is trying to do their best! This is not an easy thing to tackle by any means and it is up to all of us to let them know, give them specific examples, sitsuations and guidance. Send in your comments!!! Your friendly Food Safety Microbiologist, Donna Lynn

    • Michael Bulger

      So, the alternative that you propose is to allow contaminated water to be used on ready-to-eat produce?

      • farmber

        Organic standards require the use of non-contaminated water sources. But why should the farmer be the one to have to bear the costs of monitoring society’s water pollution problems — or from the crop losses due to not being able to use public water sources?

        Rules that require the farmer to be financially responsible for monitoring upstream pollution are inherently unfair — and benefit polluters who routinely externalize their cleanup and environmental costs.

        Of course, irrigation water containing factory chemical and farm nutrients/pesticides are by definition not covered under the proposed rules, only microbial contamination is deemed unsafe and must be tested — what kind of food safety is that?

        And for public entities — if a municipality periodically discharges untreated sewage (along with the industrial waste stream), for example –THEY should be the ones required to build super-adequate facilities and to pay for testing and remediation downstream.