(This is Part 1A of a five-part series on produce safety by Roy E. Costa, R.S., M.S., a registered professional sanitarian and founder/owner of Environ Health Associates Inc.  The series introduction was posted here on Feb. 10, 2015.) The purpose of this series on produce safety is to explain the nature of the produce industry from a food safety perspective and to explore the factors that give rise to the contamination of fresh fruits and vegetables. Most important, these articles identify areas of food safety management systems that need strengthening. This series is written for produce professionals, food safety practitioners and others who have an interest in learning about food safety in this rapidly changing and critically important arena. Food safety specialists will be needed in the coming years to assist a very large and diverse produce industry in deploying HACCP-based food safety programs. Knowledgeable practitioners are also needed to maintain the scientifically rigorous requirements of FDA’s new rules for produce under the Food Safety Modernization Act. Through this series, professionals who are familiar with HACCP in other food categories should gain valuable insights into the safe production of fresh produce and learn about produce industry operations. Fresh produce is grown in non-sterile, open environments subject to several avenues of contamination. If a fresh produce item becomes contaminated, disease-causing agents can persist and contaminate operating environments and further spread. While there are some recognized higher-risk commodities, such as sprouts, tomatoes, cantaloupe and leafy green vegetables, numerous fresh produce commodities may cause illness if exposed to environmental contamination. Therefore, ongoing and serious produce-associated outbreaks of illness continue in spite of best efforts, and produce safety has taken center stage in the national debate over how to improve the safety of our nation’s food supply. This series will explore the somewhat unique challenges of practicing food safety in agricultural settings. There are five installments planned in this series on food safety practices in the growing, harvesting, packing, processing and distribution of fresh produce items. The series begins with a discussion of food safety in packinghouse operations, a central point in the fresh produce supply chain. Packinghouse Operations A packinghouse essentially exists to provide a facility to package and preserve perishable agricultural products and prepare them for shipment. The services make the mass marketing of fruits and vegetables possible by applying final unit packaging, labeling and branding. While many products are still “field-packed,” consumer demand for fresh fruits and vegetables has created a greater need for centralized operations that allow for the production of larger quantities of products than in the past. Packing facilities evolved along with our modern transportation system as a means of coalescing agricultural products and facilitating their timely transport to population centers. Because the packinghouse is usually the first link in the supply chain after the farm, many packing operations evolved along with the farms with which they are closely associated. Packinghouse designs vary greatly from very simple structures, such as open sheds or barns, to more substantial buildings with enclosed mechanical packing lines, cooling equipment, and refrigerated storage and production areas. A packinghouse may purchase products from growers and sell them, or simply act as a storage and distribution hub (cross-dock operations). The operation may run year-round or only operate during the growing season, remaining dormant the rest of the year. A packing operation may only handle one type of product or handle a variety of products, or may be set up to handle a few similar items (carrots and onions). The farmers who grew and harvested the product may operate the packinghouse (a type of vertical integration), which may be located on the farm, or it may be an independently operated central point off the farm. In this case, several growers in a geographic area may utilize such packing and transportation services in a contractual arrangement with the owners of the packinghouse. Harvested products arrive in bulk and are typically “dumped” from the delivery vehicle or otherwise unloaded. In mechanized operations, conveyor belts and flumes move the incoming products to a mechanical packing line. Products often pass through a grading procedure to grade-out poor-quality units and are sized and sorted. Produce may be directly packed by hand into containers, or the mechanical packing line may facilitated the filling of containers with products, such as berries or grape tomatoes, dispensing products directly to the final unit package. After packaging and palletizing, hand labor, forklifts and pallet jacks are used to move products into storage. In addition to operational steps, such as receiving, grading, sorting, washing, packing, labeling, storing and shipping, packinghouses may also cool, trim, ripen (with ethylene gas), fumigate (rarely), colorize, and apply ice. “Repack” operations are specialized facilities used to recondition previously packaged products. In these types of operations, products are often graded and repackaged into new containers, then stored and shipped. Packaging includes bulk bins, boxes, cartons, clamshells, bags, and trays, and may also include value-added case-ready smaller portions of products. The facility may store packed products for extended periods and later ship them, or quickly ship them to maintain quality and freshness. Shipping may involve in-house vehicles, or contracted carriers, to move products to wholesale or retail markets, processors, or food service operations. Finally, finished products may be directly picked up by customers in their own trucks. Food Safety Regulation and Oversight In the world of agriculture, food safety is a relatively new concept. Whereas food safety in red meat and poultry production has a 100-year history, it is only since 1998, when FDA published its FDA Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables, that food safety has been a focus of the produce industry. USDA has had a close working relationship with the produce industry and sets quality standards (grades) for many types of produce and also has developed produce food safety standards (USDA-GAP) adopted by many local operations. In some jurisdictions, such as Florida, state departments of agriculture have programs to regulate aspects of the produce industry, but most farms have had very little, if any, food safety regulatory oversight. Due to the vacuum left by the absence of consistent and effective food safety regulations, the produce industry itself has developed best practices and self-regulation frameworks with the assistance of third-party auditing firms. Third parties develop standards and codes of practice in cooperation with industry and government authorities. The foundation for third-party standards are the guidance documents previously mentioned and a growing number of commodity-specific standards. These new standards are evolving in the industry; they are made up of commodity-focused quasi-governmental rules that spell out the requirements for Good Agricultural Practices (GAP), such as the California Leafy Greens Marketing Agreement, the Western Growers Association guidance for the melon industry, and the Florida Tomato GAP rule. Many primary producers are practicing voluntary compliance with guidance documents, but a large segment of the produce industry remains largely unregulated. The FDA Food Safety and Modernization Act of 2011 (FSMA) promises significant changes to food safety requirements but is yet to be implemented in produce. FSMA has been on a political roller coaster since its inception, and uncertainty and controversy still surround the rules. Many observers question whether FDA can even carry out its mission. However, FDA has entered into agreements with state departments of agriculture, and local agencies may be able to provide the needed manpower. Thanks to pressure from the world’s largest retailers, there has been movement to adopt various sets of buyer-driven voluntary standards, and today, most major produce operations, both foreign and domestic, have some type of food safety program in place. While many operations are participating, sizable portions of the U.S. produce industry remain without any food safety oversight. Firms that directly sell to food service or to smaller local and regional grocers and direct sales from farmers to consumers (farmers markets, u-pick, etc.) often lack oversight. Current Good Manufacturing Practices Packinghouses differ from “processors” (to be covered in a later article) in that a packinghouse does not significantly alter the form of the product. If products are physically altered, the requirements for processing then apply. Processing standards regarding Current Good Manufacturing Practices have been established under FDA for many years, but packinghouses have not been so regulated, and safety practices in this setting are still evolving. While food safety for the packinghouse traditionally begins when products arrive at the loading dock, the volume of incoming materials makes assessing the condition of products difficult at that point. Products arriving from growing operations may contain pesticide residues, residues of soil and foreign matter, and, occasionally, harmful microbes. Grading procedures are necessary to remove what is visibly unacceptable due to decay or damage, but of course harmful microorganisms go undetected. Personal hygiene is a key food safety issue whenever workers come in contact with produce, such as during grading, sorting and packing. The risk of contamination from a worker is dependent on how much handling is required and the nature of the product (e.g., whether it has an inedible peel or rind), or is cooked before consumption. Packinghouse operations that repack previously packaged product need to devote special attention to personal hygiene since excessive handling in such packing operations increases the risk of hand-to-food transmission, as well as cross-contamination. Well-designed and adequately supplied bathroom and hand-washing facilities in efficient locations and sufficient numbers are needed to reduce handling risks in all packinghouses. The failure to properly locate and maintain hand-washing facilities and bathrooms is a common problem and is often the result of poor planning and design. The poor design problem is the result of two missing elements: the lack of mandated or recommended plan reviews by qualified building officials and the lack of available design criteria for packinghouse facilities. Although the buyer’s standards often specify the number and location requirements for hygiene facilities, there are many existing structures without proper utilities, making after-the-fact corrections problematic. In seasonal operations, even portable toilets and portable sinks may be used. Such facilities usually lack warm water and constant maintenance is needed to maintain cleanliness, prevent wastewater spills and avoid exceeding the capacity of holding tanks, and to maintain supplies of water, soap, and other needed personal hygiene items. While workers, the production environment, and equipment can directly contaminate, or cross-contaminate products during production, perhaps the major food safety issue in packing operations involves the use of process-water.