Comment to FDA: Mark Schonbeck

From the federal docket, a thoughtful comment mindful of the needs of smaller diversified farms by consultant Mark Schonbeck to the FDA. From the docket:


Division of Dockets Management (11F A-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
Dear FDA Staff:

Thank you for the opportunity to submit comments on Docket No. FDA-2008-N-0455, Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables: Request for Comments and for Scientific Data and Information, otherwise known as Good Agricultural ractices (GAPs) and Good Manufacturing Practices (GMPs). I am a researcher in sustainable vegetable production practices, a consultant for small scale diversified organic and ecological
family farms that produce vegetables and fruits, and a regular consumer of fresh produce. I attended a GAPs Meeting sponsored by the United Fresh Research and Education Foundation in Herndon, VA on Feb. 24-25, 2009, at which produce industry stakeholders discussed the questions outlined in the September 2, 2008 Docket announcement, and developed recommendations for FDA's current revision of the GAPs/GMPs guidance. There was a wide consensus that microbial food safety is a significant issue; that all producers of fresh fruits and vegetables should be encouraged to develop and implement a Food Safety Plan based on the GAPs; and that food safety and record keeping procedures can and should be scale-ppropriate, and thus affordable and practical for the small-scale diversified farm as well as larger scale operations. In addition, there was wide agreement that GAPs guidance any future regulations must be science based and targeted at known or likely significant risks. Finally a concern was expressed by small and large scale farmers alike that individual buyers and private third-party auditing firms are imposing extreme arid sometimes conflicting requirements on their producers, often in a competitive effort to see who can offer the consumer the "safest" product. In addition to adding considerably to production costs, some of these requirements deter good ecological farming practices to conserve and improve soils and protect water and wildlife resources. I would like especially to comment on several aspects of the GAPs guidelines and how they might be updated and clarified to address several concerns that have arisen in the development of the Leafy Greens Marketing Agreements in CA and AZ, and the recently implemented Tomato Regulation in the State of Florida; and that will likely arise in future commodity-specific marketing agreements or produce safety regulations. The current Leafy Greens Marketing Agreements (LGMA) mandate a 30ft wide bare soil buffer between leafy greens. fields and cattle grazing land, and measures to exclude wildlife from production fields . Many private auditing firms implement "super metrics" that go far beyond this to require farmers to remove all vegetation from buffers 100 ft or more in widtli, between production fields and either grazing lands or lands to which wildlife have access. Farmers have also destroyed hedgrows and woodlands adjacent to fields, or between fields and streams in order to meet buyers' and auditors' requirements, based on a belief that any access of wildlife of any form to these fields carries a significant foodborne pathogen risk. These requirements are counterproductive on three counts . First, bare soil "buffers" increase risks of hemmorhagic E. coli (e.g. 0157:H7) and other virulent foodborne pathogens entering produce fields in runoff waters or windblown dust from cattle feedlots or grazing lands. There is some evidence that the source of E. coli 0157 :H7 in the 2006 California spinach outbreak might have been dust blown from cattle operations into leafy greens crops; and vegetated buffers such as windbreaks and hedgerows are known to reduce dust movement into fields (Benbrook, 2007; Richardson, 2008). Grasslands and wetlands can effectively filter E. coli and other pathogens out of runoff water, with as little as six feet of buffer reducing microbial populations 70-99% (Knox et al, 2007; Tate et al., 2005); without such vegetation, rainwater can rapidly distribute the pathogens (Meadows, 2007). Second, the LGMA and the "super-metrics" demanded by some leafy greens buyers and third party auditors seem to assign uniform value to the risks posed by wildlife and domestic livestock.Studies indicate that cattle are the primary source and carrier of dangerous strains of E. coli; that cattle in large feedlots or concentrated animal feeding operations (CAFOs) shed higher numbers than grazing cattle ; and that deer and other wildlife carry much lower numbers of E. coli (Hussein, 2007; Stuart et al., 2006; Diez-Gonzales et al., 1998). Finally, maintenance of bare soil zones and destruction of wildlife habitat run counter to the basic principles of sustainable farming systems, and may contradict USDA Natural Resources Conservation Service (NRCS) or state conservation programs in which many farmers participate to protect soil, water quality and other natural resources (Stuart et al, 2006). In California's Central Coastal region, a majority of growers managing 140,000 acres have removed conservation practices for water quality and wildlife habitat (RCD of Monterey County, 2007). In addition, the USDA National Organic Program (NOP) mandates farming practices that protect and improve soil quality. Bare soil is especially prone to water and wind erosion as well as rapid loss of organic matter and soil life, factors which lead to severe soil degradation. It is vital that any commodity marketing agreements aimed at food safety based on GAPs guidelines identify and address the points of highest risk for each commodity, and that the benefits as well as possible risks related to wildlife habitat, vegetated buffers and other ecological farming practices be taken into account. For example, fresh-cut bagged greens are inherently much riskier than bunched greens or lettuce cut as whole heads, as the former create a favorable environment for pathogens growth. A vegetated buffer consisting of trees, shrubs and perennial grasses may harbor wildlife, yet greatly attenuate greater risks from dust or runoff from neighboring livestock operations . In all cases, risk assessments must be science based to the greatest extent practical, and be ,updated periodically as new research findings accrue . On a related topic, the GAPs guidelines recommend careful management of livestock manures, which has been interpreted in the LGMA and other proposed agreements to mandate the exclusion of all manure from production fields altogether. Again, this runs counter to basic principles of sustainable production, as a great volume of research over the past century has shown that judicious use of composted or aged manures is essential for maintaining the high soil microbial diversity and biological activity that is vital to soil quality, and thus the quality and yield of produce grown thereon. High populations and diversity of beneficial soil microorganisms have been shown to shorten the half life of human as well as plant pathogens in the soil (Van Gruggen, 1995; Johannessen et. al, 2005). Thus the objectives of food safety and of long term sustainability of our agricultural soils and faming systems can and must be pursued in ways that are mutually compatible and even synergistic: Specific recommendations for the FDA GAPS Guide:

Question 9: Would it be useful to enhance the coverage of [environmental assessments] in the GAPs/GMPs Guide?
Yes, the GAPs/GMPs Guide can offer additional guidance in evaluating both potential
hazard points and benefits of a farm's production system, in relation to known or likely hazards in its surroundings . Guidance should be offered in assessing:" hazards such as proximity to livestock farming operations and especially CAFOs, and factors such as topography, prevailing winds, runoff patterns, and vegetation present between the
livestock area and fruit/vegetable production fields ; and " current or potential mitigation strategies such as grassed or other vegetative buffers to intercept dust or runoff, grassed waterways to divert and filter runoff, and soil quality enhancement through organic or ecological production systems. The Guide should also provide some practical science-based guidelines for the safe use of livestock manures, especially those produced on-site on diversified crop-livestock farms; to replenish and maintain soil fertility. Measures such as maintaining adequate vegetated buffers between manure storage/composting areas and production fields and preventing or diverting runoff; utilizing manures at time of cover crop planting (four to six months prior to the next harvest of fresh produce); manure composting or aging; and a minimum interval between manure that has not been hot-composted (> 131 °F for 15 days) and produce harvest, can be recommended. The National Organic Program mandates a 120 day interval . These recommendations should be refined as additional research into manure composting and management, and effects on populations of harmful and beneficial soil microbes is completed. Because responsible use of on-farm manure is one of the most effective and ecologically sound methods of maintaining soil fertility and microbiological diversity, the Guide should mandate ;that small diversified farms not be required to exclude all manure use from their fruit and vegetable fields . The hazards posed by declining soil productivity resulting from not recycling composted animal wastes back onto the land may include obesity, malnutrition and even hunger as the quantity and quality of fresh produce available to the American consumer diminishes . These factors must be weighed in determining the best food safety practices on the farm.

Question 11 : Could/should the GAPs/GMPs Guide do more to ident fy, address and possibly mitigate unintended environmental consequences of food safety measures?
Yes, the Guide should address these issues . A farm's food safety plan must be compatible with the farm's current or future practices aimed at protecting and improving environmental quality including water, soil and air resources; as well as wildlife habitat and hedgerow plantings that enhance crop pest control by harboring natural enemies of pests. For example, the maintenance of bare-soil buffers around production fields should be discouraged as counterproductive to food safety (as discussed above) as well as farmworker safety (dust inhalation), farmland productivity, soil quality and environmental quality. The Guide should provide examples of practices that mitigate both food safety hazards and environmental impacts, such as vegetated buffers around production fields . Guidance related to wildlife management in and around production fields should be linked to an impartial scientific assessment of the risks (or lack of risks) posed by different wildlife species in a given region, and should help the grower evaluate the benefits as well as risks of wildlife habitat in proximity to production fields, rather than giving a blanket recommendation for its removal.

Question 12: Are there existing regulatory requirements . . . that should be taken into consideration when updating this guidance to reduce the risk of microbial contamination of fresh produce?
Yes. A significant and growing percentage of fruit and vegetable farmers in the United States are becoming USDA Certified Organic, and others are following the USDA standards without undergoing formal certification. GAPs Guidance for organic producers should be harmonized with the National Organic Standards, and should not conflict with requirements that organic farmers continue to improve their soil's organic matter and to conserve biodiversity on their farms (National Organic Program, 2009). Many farms also participate in NRCS or state level programs aimed at conserving natural resources including soil, water quality, native plants and wildlife . GAPs guidance should be worded in a way that encourages farmers to continue participating in these programs, and should recommend that farmers not take measures, such as ineffective and erosion-prone bare-soil buffers, or wildlife habitat destruction, that defeat the purpose of conservation programs without adding materially to the microbiological safety of produce .

Finally; GAPs guidelines should address the needs of small scale diversified farms that grow as many as 20-40 different fruit and vegetable crops. The guide should recommend that record keeping requirements focus on documenting that the farm has identified and mitigated priority potential food safety hazards. Record keeping requirements should not force the small-scale farmer to conduct tests and keep detailed records on each crop and harvest, a task that would be financially and logistically infeasibie, and shut smaller farms out of the market. Even the large scale producers at the Feb., 2009 United Fresh meeting generally agreed that a small farm operated by an individual, couple or family without hired employees, and supplying local markets, might meet food safety goals through a simple Food Safety Plan, common sense cleanliness and sanitation, good manure management, and document compliance with a few pages of records per season. Thank you for the opportunity to submit these comments and recommendations on the revision of the FDA GAPs/GMPs Guide.


Sincerely,
Mark Schonbeck, Ph.D.
Consultant in Sustainable Agriculture