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Docket No. FDA-2008-N-0455
Division of Dockets Management (HFA-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 Practices (GAPs) and Good Manufacturing Practices (GMPs). I am the Policy Coordinator for the Northeast Organic Farming Association Interstate Council (NOFA-IC), representing the seven state NOFA organizations: NOFA-NY, NOFA-VT, NOFA-NH, NOFA-MASS, NOFA-RI, NOFA-CT and NOFA-NJ.

Started in 1972, NOFA is one of the oldest organic farming groups in the country. NOFA membership consists of farmers, gardeners and consumers concerned with food quality and sustainable agriculture as well as health, energy use and environmental stewardship. Our farming members tend to be locally-based, small-scale sustainable and certified organic farmers who market directly to consumers through Farmers Markets, Community Supported Agriculture (CSA) programs and Roadside Stands as well as through small scale wholesale markets such as restaurants and farm to school programs.

Food safety is a paramount concern at all levels of production. While a single contamination event in the large-scale, centralized food production and distribution system can put tens of thousands of consumers at risk over a multi-state area, fresh produce contamination can occur at all farming scales from industrial to local. Importantly, however, appropriate risk management and mitigation precepts are not a one-size-fits-all remedy. And while no growers are exempt, effective food safety parameters must be fair, scaleable (with an understanding of resource limitations,) science-based and product-appropriate.

Further, the recently reported 2007 Agricultural Census shows significant growth in the number of new, highly diversified small-scale farms all across the country. Coupled with an increase in localized markets and mounting consumer interest in locally grown food there is an expansion of Farmers Markets, CSAs, farm stands, restaurants and school programs featuring local produce. Local farmers are playing an increasingly important role in the food system. Research shows that access to fresh fruit and vegetables is a major contributor to community health. Therefore, any procedures under consideration by the FDA must be affordable, small-business friendly and practical for the small-scale diversified farm as well as larger scale operations.

To these ends, NOFA has helped establish the "Leafy Greens Working Group" -- a consortium of organic and sustainable farming organizations from Maine to Florida working in collaboration with food safety experts and specialists around the country to develop and deliver HAACP-based on-farm food safety training to this underserved small farmer demographic. Experience shows that these growers respond best to peer education, preventive scale-appropriate parameters and voluntary, non-regulatory initiatives.

In this regard, NOFA is also concerned that individual wholesale buyers and private third-party auditing firms are imposing extreme and sometimes conflicting requirements on their producers, often in response to perceived legal liability - and with their own proprietary interests at heart. For smaller farmers these non-appropriately scaled mandates add inordinately to production costs, with the potential to put them out of business. NOFA strongly recommends that any clarifications and updates to the GAPs Guidelines address these important scale differences and that implementation remains completely voluntary.

Also worrisome is the industry response to the 2006 E coli 0157:H7 outbreak on spinach that resulted in the California-based Leafy Greens Marketing Agreement (LGMA.) Many of these requirements reverse and actually preclude tried and true ecological farming practices that conserve and improve soils and protect water and wildlife resources. Moreover, these misguided requirements totally run counter to the renewed emphasis by USDA's National Organic Program (NOP) requiring certified organic farmers to amplify beneficial biodiversity provisions in their organic farm plan. Further, the NOP has long had some food safety measures firmly in place - such as requiring produce traceability via a documented audit trail as well as stringent manure use and composting regulations.

In this case, while the GAPs guidelines recommend careful management of livestock manures, the LGMA has interpreted this to mandate the total exclusion of all manure from production fields. This runs counter to basic principles of organic and sustainable production. A great volume of research 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 as well as enhanced yields and nutritional quality of produce. Further, high populations of diverse 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). FDA's food safety objectives must therefore be compatible with long-proven sustainable organic farming practices.

Maintenance of bare soil zones and destruction of wildlife habitat also 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). These untenable dictates of the LGMA are coming under greater public and scientific scrutiny as a result and have no place in FDA GAPs guidance.

Finally, in addition to the above research citations, NOFA also endorses the following specific recommendations made by researcher Mark Schonbeck, Ph.D., a consultant in sustainable agriculture and a member of the NOFA-led Leafy Greens Working Group:

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 (>131F 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 identify, 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 infeasible, 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 Guide.

Steve Gilman
NOFA-IC Policy Coordinator


Benbrook, C. 2007. Unfinished business: Preventing E coli 0157 outbreaks in leafy greens. Critical Issue Report (June). The Organic Center.

Diez-Gonzales, F., T.R. Callaway, M.G. Kizoulis and J.B. Russell. 1998. Grain feeding and the dissemination of acid-resistant Eschericia coli from cattle. Science 281: 1666-1668.

Hussein, H. 2007. Prevalence and pathogenicity of Shiga toxin-producing Escherichia coli in beef cattle and their products. Journal of Animal Science 85 (March).

Johannessen, G.S., G.B. Bengtsson, B.T. Heiser, S. Bredholt, Y. Wasteson and L.M. rorvik. 2005. Potential uptake of Escherichia coli 0157:H7 from organic manure into crisphead lettuce. Applied and Environmental Microbiology 71(5): 2221-2225.

Knox, A.K., K.W. Tate, R.A. Dahlgren and E.R. Atwill. 2007. Management reduces E. coli in irrigated pasture runoff. California Agriculture 61, no. 4.

Meadows, M. 2007. How the FDA works to keep produce safe. FDA Consumer (March/Apil).

National Organic Program. 2009.

Richardson, L. 2008. GAP metrics a work in progress. California Farmer (March).

Resource Conservation District of Monterey County, CA. 2007. A growers survey: reconciling food safety and environmental protection. August.

Stuart, D., C. Sherman and M. Brown. 2006. food safety versus environmental protection on the Central California Coast: exploring the science behind an apparent conflict. UCSC, The Center for Agroecology and Sustainable Food Systems. Research brief #10, fall.

Tate, K., R. Atwill, M. Pereria, A. K. Knox and R. Dahlgren. 2006. Significant Eschericia coli attenuation by vegetative buffers on annual grasslands. Journal of Environmental Quality 35.

Van Bruggen, A.H.C. 1995. Plant disease severity in high-input compared to reduced-input and organic farming systems. Plant disease 79: 976-984.

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