Michelle A. Smith
Center for Food Safety and Applied Nutrition (HFS-317)
Food and Drug Administration
5100 Paint Branch Pkwy.
College Park, MD 20740-3835
July 23, 2010
RE: FDA Docket No. FDA-2010-N-0085, “Preventive Controls for Fresh Produce; Request for Comments”
Dear Ms. Smith,
The Organic Trade Association (OTA) would like to thank the Food and Drug Administration for this opportunity to provide information and share our views to help inform the development of safety standards for fresh produce at the farm and packing house and strategies and cooperative efforts to ensure compliance.
OTA is a not-for-profit 501(c)(6) trade association representing over 1200 organic businesses across the supply chain in the US and Canada. OTA strongly supports improvements in food safety and supports the preventive approach taken by this notice.
OTA has three main concerns regarding this regulation. 1) We understand this is rulemaking focuses on prevention of contamination, but we would like to stress that this regulation should be consistent with 7 CFR 205 (the National Organic Program), including not requiring the use of any prohibited materials or practices. 2) We would like to avoid duplicative efforts where possible, including recordkeeping and inspection. Organic agriculture is the most highly regulated system of agricultural production in the U.S., and the USDA-accredited verification system, especially its recordkeeping and inspection requirements, should be recognized and considered by FDA when drafting rules requiring similar features. 3) We would like to note that issues may vary according to production method and scale, and urge FDA to be cautious when considering one-size-fits-all regulations.
Finally, we note that USDA’s Agricultural Marketing Service is also engaging in efforts regarding the safety of fresh produce, and we provide for the record OTA’s position on the organic agricultural system and food safety.
OTA’s main concern is that safety standards and ensuring compliance not conflict with, or provide any undue burden on, organic farmers. Organic agriculture relies on diverse agroecological factors for pest and weed control, and some food safety process controls that might be suitable for differently managed operations might not be suitable for operations which rely on a diverse agroecological system; for example, systems including mixed crop and livestock operations.
To that end, OTA recommends that any risk management assessment system allow for management of farms for both conservation purposes and food safety (sometimes called “co-management”). In particular, regulations should not conflict with the goals or practices of farmers complying with the conservation requirements of the Endangered Species Act, the programs of USDA’s Natural Resource Conservation Service or National Organic Program.
OTA cautions against unnecessary duplication of effort in order for farmers to comply. For example, we hope FDA recognizes the existence of farms which grow multiple fruit and vegetable crops and so need a way to comply with general guidance from FDA without having to satisfy all the requirements of multiple guidance documents for specific crops. A prevention-based system should be able to be based on principles that would hold true for any crop, with at most general categories sufficing for guidance rather than a growing list of crop-specific guidance.
OTA has encouraged AMS’ Inspection Service to provide food safety training for inspectors used by organic accredited certifying agents so they may inspect or audit on USDA’s behalf (Section 970.14, definition of Inspection Service). Similarly, OTA suggests that any FDA food safety verification procedures for organic farmers be developed in conjunction with USDA-accredited certifying agents for the National Organic Program in order to reduce duplication of effort and the burden on producers.
Production methods and scale
The National Organic Program rule (7 CFR 205) requires that organic farm production practices maintain or improve the natural resources of the operation, including soil, water, wetlands, woodlands and wildlife.(1) The definition of organic farming within that rule (7 CFR 205.2) is:
Organic production. A production system that is managed in accordance with the Act and regulations in this part to respond to site-specific conditions by integrating cultural, biological, and mechanical practices that foster cycling of resources, promote ecological balance, and conserve biodiversity (emphasis added).
OTA notes that diversified farming systems with well-managed soils, vegetated buffers, and high levels of biodiversity are very much compatible with safe food, and through a balanced ecological system providing environmental services such as filtering and buffering, serve to enhance and promote the goal of food safety. The conservation and restoration of grasses and wetlands that filter pathogens, and the promotion of diverse soil microorganisms that are antagonistic to these pathogens, increase the safety of food. Audit metrics should target the areas of greatest risk, and those risks should be based on sound science, especially including ecological science (including soil ecology).
OTA notes that organic farmers “feed the soil” with cover crops and compost and aid beneficial microorganisms by not using acidic fertilizers or toxic fumigants. This is very important for food safety in organic operations since research shows pathogenic E. coli declines more rapidly in soils with a large diversity of microorganisms as opposed to sterile soils due to antagonistic interactions with indigenous life in the soil.(2)
Thus OTA is confident that the agroecological approach of organic agricultural systems can result in operations that are among the most safe possible, and we ask FDA to take this science and these systems into consideration when drafting any guidance or regulation.
As an organization with a diverse membership, OTA notes that a disproportionate burden of implementing this approach may well fall on small and medium-sized operations,(3) and the approach should reflect this reality as FDA moves to implement preventive controls. For example, AMS’ proposed Section 970.66, verification audits, refers to its Section 970.9, the definition of “good agricultural and handling practices,” which cites the FDA’s “Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables.” OTA believes that this guide provides an appropriate level of specificity regarding outcomes without being overly prescriptive as to methods, an approach we believe is best for small and medium-sized operations.
USDA’s Agricultural Marketing Service efforts
We note that USDA’s Agricultural Marketing Service (AMS) is also working on preventive controls for leafy greens through the LGMA and hereby request that FDA coordinate its efforts with AMS. OTA has noted its concerns regarding the effects of certain practices in California under the California Leafy Green Marketing Agreement in our comments to AMS,(4) which seem in opposition to conservation and biodiversity, prior to the proposal if any similar practices under this Agreement. Clearly there are higher-risk species and lower-risk species, and diversified farms may not be culpable generators of food borne illnesses as much as passive vectors of external causes,(5) for which leafy green growers should not have to carry the burden.
Regarding the applicability of 21 CFR 110 to this effort, OTA requests that a clear line be drawn between post-harvest handling (for example, the rinsing of leafy greens) and processing. This could require FDA to answer more detailed questions that are asked in the current notice, but the results would protect farmers who are not processors from having to comply with regulations that were not intended for farms.
Also relevant to the current comment, OTA’s comments to AMS regarding the National Leafy Greens Marketing Agreement included the following answers to AMS questions (AMS questions are in italic):
What specific problems or issues should be addressed by such a marketing program?
OTA has two primary concerns about such a marketing program: First, it should not impose any requirements that would conflict with National Organic Program regulations or the requirements of the underlying statute, the Organic Foods Production Act of 1990, particularly with respect to use of disinfectant substances. Second, it should not prescribe practices that would lead to reduced biodiversity on participating farms, such as elimination of hedgerows and reduction of soil microbial populations. Evidence suggests that maintaining a diverse population of soil organisms is an effective means of keeping potential human pathogens in check.
Would Best Practices based upon FDA guidelines be the best criteria for regulation of leafy green handling, or are there other criteria available that might better meet the industry's needs?
We strongly urge that such a program be based on performance standards, using objective metrics for outcomes such as routine microbiological monitoring. While such testing protocols would not be part of the organic practices, organic producers meet food safety requirements in addition to meeting National Organic Program standards, and could perform reasonable monitoring in addition to the documentation required under the NOP. AMS could provide oversight for such a quality monitoring regime based on the model of its own Qualified Through Verification Program, including auditing of Good Agricultural Practices/Good Handling Practices (GAP/GHP).
Which specific leafy green commodities should be included under the program's handling regulations?
We suggest that this program be limited to leafy green commodities that are prepared and sold in a form intended to be consumed in the same condition, for instance without additional cooking, by the final consumer. For example, fresh cut salad mix should be covered, but not greens that are commonly cooked such as kale or swiss chard.
What are potential obstacles to the implementation of such a marketing program? For example, would distance make it impractical for the committee to meet frequently? Might regional subcommittees be appointed to meet more frequently and consider local matters for presentation at annual national committee meetings?
We do not know of specific obstacles to implementation, such as those suggested in the docket.
What are the potential costs associated with the implementation of such a program, including changes to current production and handling procedures, assessments, and audits?
Such a program would clearly incur costs to producers, including additional employee time, costs of monitoring, and audits. We would urge AMS to minimize such costs wherever possible, for example by requiring less expensive routine microbiological monitoring methods, and by use of risk based protocols that permit initial screening followed by more intensive testing if indicated. We also suggest that funding be sought for technical assistance to producers to gain knowledge about compliance with such a program, as well as education for producers in improved production methods. (Such training has been offered when other programs have been implemented by USDA.)
How would a marketing program complement, duplicate, or conflict with any other existing programs, such as state food safety regulations?
In addition to remaining consistent with the NOP, such a program would also be consistent with GMPs and GAPs, HACCP, Federal procurement requirements, and federal, state and private food safety programs.
Are there other issues and/or suggestions about such a marketing program?
One serious issue that should be considered is the question of imported leafy green products. We believe that a significant volume of such products could enter the U.S. from both Canada and Mexico, which could potentially put domestic producers at a disadvantage if they have to meet standards that are not required of foreign competitors.
OTA notes that the National Organic Program is the only instance in federal law or regulation where the use of manure is regulated. Stringent rules govern the application of uncomposted manure to land used to produce organic crops, and leafy greens cannot be harvested less than 120 days after an application of uncomposted manure. Requirements for composted manures provide additional pathogen reduction measures. We suggest that compliance with the NOP with regard to use of animal manure, combined with a microbiological monitoring program for preharvest produce, is sufficient to assure consumers of the safety of ready to eat leafy greens.
For the record, OTA would like to place on the record our position on the organic agricultural system and food safety:
All products that are marketed and sold as “certified organic” in the United States must meet the requirements of the Organic Foods Production Act of 1990 (OFPA).(6) This statute, Title XXIII of the Food, Agriculture, Conservation and Trade Act of 1990 (the Farm Bill), required the U.S. Department of Agriculture (USDA) to published regulations governing the entire system of organic production and processing. The regulations cover crops and livestock on the farm and any processing and handling of products to create a far-reaching and innovative set of regulations. Organic producers and handlers are also required to comply with all local, state and federal laws and regulations.
Organic refers to how farm products are grown, processed and handled, and use of the term organic on the label of a food or beverage product denotes that it meets or exceeds U.S. national organic standards. Organic producers and processors must adhere to rigorous growing and processing standards, and farms and processors must have their organic system plans and their facilities inspected at least annually by an agent of the USDA, an accredited certification agent. There are 98 accredited certification agencies in operation globally.
All certified organic farms and production facilities are registered with the U.S. Department of Agriculture, and USDA accredits third party certifiers to the National Organic Standard/Program.
As labeling terms, organic and natural are not interchangeable.
As noted, all applicable local, state and federal requirements for food safety are followed on organic farms and processing facilities, additionally, there are some unique processes required in organic farming and manufacturing that could assist in consideration of food safety legislation:
There are some unique perspectives and points of organic farming and manufacturing that deserve consideration when food safety legislation is being crafted.
• The organic system is built on third-party certification, audit trails/traceability and inspections.
• The organic regulation includes a process to review and approve or disapprove new materials, processes and methods as they come to market.
• Organic compliance begins on the farm, and any processing or handling must maintain that integrity all the way through the food chain to the consumer.
• Manure use on organic farms is strictly regulated by the organic standards to substantially minimize the potential for contamination of crops.
• Organic farms build healthy soils without the use of toxic and persistent pesticides and chemical fertilizers, and without the use of sewage sludge.
The organic industry takes food safety seriously and embraces Congressional and Agency efforts and their intended outcome of a safer food supply.
As a certified process, the organic food industry is uniquely positioned to respond to food safety requirements in ways that are not in effect in other food sectors. The organic foods industry has legally mandated safeguards that contribute to food safety for consumers, including full food product traceability, accountability of food production methods, and strict controls on known potential sources of food contamination such as manure and toxic, synthetic pesticide residues. Organic producers and handlers are already familiar with planning, regulatory oversight, third-party certification, and independent inspections. Certified organic growers follow strict guidelines for organic food production and, as with all food producers, they must comply with local, state and federal food safety and health standards. Familiarity with these requirements positions the organic sector well in terms of complying with future efforts to improve food safety systems in the U.S.
The organic certification system allows all producers and processors, small and large, the flexibility to maintain traceability records appropriate to the type and scale of operation, i.e. manually or electronically. The record keeping system is outlined in the organic system plan. Independent third-party onsite inspections verify each of these organic system plans and their implementation annually, thus providing excellent accountability.
Ultimately, regardless of scale or type of farming operation, every operation must understand and addresses its specific on-farm risks.
1) All organic farmers and processors are registered with the U.S.D.A.
As required by the National Organic Program regulation subsection §205.100 – What has to be certified, each production or handling operation or specific portion of a production or handling operation that produces or handles organic products must be certified according to the provisions of the certification section. Certification agents are accredited by the U.S.D.A.
2) Third-party oversight. All organic producers and handlers are subject to oversight by third-party certifiers accredited by the U.S.D.A.
As required by the general requirements for certification subsection §205.400 – Any entity seeking to maintain organic certification must comply with “the act” and establish and implement, and update annually an organic production and/or handling system plan that is submitted to an accredited certifier.
3) Inspections of organic operations. All organic producers and handlers are subject to initial and annual on-site inspections. Additionally certifiers may conduct additional announced or unannounced inspections to determine compliance with the governing organic standards. As required by the general requirements for certification subsection §205.403 – On site inspections.
4) Organic farmers and processors are required by law to maintain records that allow “one up, one down” traceability for all inputs and for all sales. Authorized entities, accredited certifiers, maintain and have access to full chain traceability.
As required by the National Organic Program regulation sub-section §205.103– recordkeeping, all certified operations must maintain records pertaining to the production, harvesting and handling of agricultural products intended to be sold as organic. Records must document all activities and transactions in sufficient detail to be audited and must be maintained for a minimum of five years. Records must be made available for inspection (announced or unannounced) by representatives of the Secretary of Agriculture, applicable State program’s governing official, or the certifying agent. From field to fork, every entity in the supply chain or in the stream of commerce must maintain an audit trail that permits full traceability and accountability.
5) Organic is the only segment of agriculture that has rigorous national regulations regarding the application of manure on farms.
Organic food production is the only segment of the food industry where animal manure is strictly regulated as an input to agriculture for purposes of safety. The U.S. regulations for organic production impose strict requirements for the use of animal manure if it is used on the farm. The regulations require that raw animal manure must be composted unless it is applied to land used for a crop not intended for human consumption; or is incorporated into the soil not less than 120 days prior to the harvest of a product whose edible portion has direct contact with soil; or is incorporated into the soil not less than 90 days prior to the harvest of a product whose edible portion does not have direct contact with the soil surface or soil particles. See 7 CFR 205.203 (c) (1) and (2). The purpose of these restrictions is to substantially minimize the potential for contamination of organic crops by raw manure.
6) Compost made with animal manure must meet temperature, mixing, and time requirements to ensure its safety.
The requirements for making compost are well regulated and are designed to encourage soil health while minimizing risks to human health or the environment. The National Organic Program Rule defines compost (7 CFR 205.2) as follows:
Compost: The product of a managed process through which microorganisms break down plant and animal materials into more available forms suitable for application to the soil. Compost must be produced through a process that combines plant and animal materials with an initial Carbon:Nitrogen ratio of between 25:1 and 40:1. Producers using an in-vessel or static aerated pile system must maintain the composting materials at a temperature between 131 deg. F and 170 deg. F for 3 days. Producers using a windrow system must maintain the composting materials at a temperature between 131 deg. F and 170 deg. F for 15 days, during which time the materials must be turned a minimum of five times. The purpose of these requirements is to substantially minimize the ability of human pathogens to survive the composting process and pose a food safety problem with the organic crop.
7) Organic farmers are required to maintain or improve soil and water quality.
As required by the National Organic Program regulation subsection §205.200 - Production practices implemented in accordance with this subpart must maintain or improve the natural resources of the operation, including soil and water quality. Additionally, sub-section §205.203 soil fertility and crop nutrient management practice standard requires a producer must manage crop nutrients and soil fertility to maintain or improve soil organic matter content in a manner that does not contribute to contamination of crops, soil, or water by plant nutrients, pathogenic organisms, heavy metals, or residues of prohibited substances.
8) Organic production permits anti-microbial steps to be taken to lower pathogen contamination
Pasteurization, restricted use of chlorine and hydrogen peroxide, equipment sanitation, and other food safety practices are also utilized by organic food producers and handlers to assure the safety of organic foods. These processes are permitted under the National Organic Program.
9) Antibiotics are prohibited in livestock feed and routine organic health programs. Organic farms do not increase the risk of creating antibiotic resistant bacteria.
As required by the Organic Production and Handling Requirements sub-section §205.238 – Livestock healthcare practice standard, healthy living conditions and attentive care are considered first steps in the prevention of illness. Therefore, animals must not be overcrowded, and must be allowed periodic access to the outdoors and direct sunlight. Antibiotics are not used to treat organically raised animals in the United States, and if, for humane reasons, an animal must be treated with an antibiotic, then it is removed to a conventional herd, and not returned to organic status.
10) Organic livestock cannot be fed animal by-products, adding a layer of protection against the possibility of transmission of certain diseases.
This prohibition exceeds current non-organic rules which, for example, allow non-mammalian animal by-products to be fed to cattle and vice versa.
Steps taken to ensure regulatory compliance can be considered “organic control points” similar to the “critical control points” considered in hazard analysis. Some of these are detailed and directly transferable to food safety issues, such as the documentation of the non-use of prohibited materials and the plans for compost and manure management. With these systems and documentation protocols in place, the organic system offers an integrated process approach to preventive food safety practices that could stand as a national model for both farming and manufacturing operations. The organic process already contains many steps that contribute to food safety processes and it can be easily integrated into a more elaborate food safety system – especially in processing.
Thank you very much for your consideration.
1 See, for example, Sec. 205.200 General; Sec. 205.203 Soil fertility and crop nutrient management practice standard; and Sec. 205.205 Crop rotation practice standard.
2 Xiuping Jiang, J. Morgan, and M. P. Doyle. Fate of Escherichia coli O157:H7 in Manure-Amended Soil. Applied and Environmental Microbiology, May 2002, p. 2605–2609.
3 Hardesty, Shermain D., and Toko Kusunose. Growers Compliance Costs for the Leafy Greens Marketing Agreement and Other Food Safety Programs. UC Small Farms Program Research Brief, September, 2009.
4 See http://www.ota.com/pp/otaposition/frc/amsleafygreens.html.
5 California Department of Fish and Game, news release, Preliminary Results Find Less Than Half of One Percent Occurrences of E. coli O157:H7 in Wildlife in California Central Coast Counties, April 7, 2009.
6 7 U.S.C. 6501 et seq.