Abstract: The safety of produce and its production has come under scrutiny as the results of repeated and serious outbreaks of foodborne illness. Environmental health standards for sanitation, personal hygiene, water, and soil quality during farming operations are now recognized as critical for the safety of produce. Public health and rregulatory initiatives targeting produce are underway in Florida, California, and other jurisdictions as a result of numerous outbreaks of E. coli O157:H7 and Salmonella. The California Senate last year approved three bills designed to implement tougher food safety rules for growers and handlers of spinach and other leafy greens. In addition, the California Department of Food and Agriculture (CDFA) is administering a voluntary California Leafy Greens Marketing Agreement (Marketing Agreement) requiring Good Agricultural Practices (GAP). Florida is regulating tomato safety through the Department of Agriculture and Consumer Services (DACS). Environmental health practitioners have many of the skills needed to address the challenge of regulating on-farm food safety. State public health agencies are applying public health protection programs to farms and the role of the sanitarian/environmental health specialist is essential.
Environmental Health on the Farm
The safety of produce depends on many environmental health factors from the farm to the consumer’s plate. For example, intensive farming of leafy green vegetables occurs in the Salinas Valley on the central coast of California. In this location, farms are subject to flooding from the polluted Salinas River and its tributaries. One major source of pollution in the basin is the surface water run off from the valley’s extensive cattle operations. In addition to polluted water, reservoirs of pathogens include workers, cattle, manure, and wildlife. Once produce is contaminated, pathogens are difficult to remove. Modern distribution and processing systems contribute to the rapid and wide dispersion of contamination if it occurs. There is also a high demand for fresh-cut (processed) produce at the retail level. High demand has increased the amount of processed produce in the marketplace and the numbers of people potentially exposed to farm pathogens. These factors, mostly related to the environment crops are grown in, are causing large and numerous outbreaks of foodborne illness. Experts now recognize the farm as a critical link in the safety of the nation’s food supply and environmental health professionals are now at work in this area.
Following environmental health standards in farming is a new concept. Traditionally, environmental health programs have not focused on produce safety on the farm, but legislatures are now considering laws and rules to stop the spread of disease through produce, as they have done in the past with milk, seafood and meat. Environmental health programs at all levels must expand to confront the risks to public health posed by human health hazards originating in the farming environment.
Recent Produce Outbreaks
In 2006, produce-borne E coli O157:H7 in spinach and lettuce, and Salmonella in tomatoes, caused several well-publicized and serious outbreaks. In the spinach outbreak, contaminated produce eventually reached 26 states and caused over 200 cases and at least 3 deaths. California leafy greens caused a total of 22 reported outbreaks in the last 12 years, and the Salinas Valley was the source of produce in nine of them. The “Investigation of an Escherichia coli O157:H7 Outbreak Associated with Dole Prepackaged Spinach”, released March 21, 2007, may be the first investigation to link a produce-borne pathogen to a specific US farm. Close on the heels of the spinach outbreak, investigators traced California grown lettuce to 2 outbreaks E coli O157:H7 at two national taco chains. In 2008 the US experienced one of its worst outbreaks of salmonella through contaminated produce with both peppers and tomatoes associated with illnesses.
California’s Proposed Regulations and Voluntary Programs
California legislatures are seeking to make the California Department of Health the regulator of mandatory on-farm food safety under a series of bills sponsored by state Sen. Dean Florez A competing industry level program is already in place, and it is questionable whether the bills have strong industry support. The voluntary program is an industry effort supported by the California Department of Food and Agriculture (CDFA). Most of the largest produce growers in California this March signed on to the “California Leafy Greens Marketing Agreement” (Marketing Agreement) allowing the CDFA to conduct GAP (Good Agricultural Practices) inspections on farms, packinghouses and processing plants,. With 99% of produce grown in California under the Marketing Agreement, and inspections and audits occurring, farms will more consistently apply Good Agricultural Practices. However, there is skepticism about the sufficiency of voluntary controls alone. If we experience another large outbreak with leafy greens, calls will undoubtedly arise again for public health agencies to intervene.
Weakness in the Buyer Driven Food Safety Model
FDA first published a “Draft Guidance for Industry; Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables” in 1998, and in March of 2007 issued a “Final Draft” form. The Guide met with general approval by agriculture, but compliance still remains “non-binding”. Industry at some level has adopted the guidance, but compliance is not uniform and we continue to see significant outbreaks involving fruits and vegetables. The FDA also published the “Commodity Specific Food Safety Guidelines for the Lettuce and Leafy Greens Supply Chain.-1st Edition” in 2006and a second edition in February of 2007. This guidance also lacks the force of regulations, and how well the supply chain follows FDA guidance is unknown. For these reasons, many feel there is a need for a specific body of rules that all must follow.
Because industry with or without mandatory rules must still supply a safe product, the produce industry has been operating a self-regulating “buyer-driven” food safety system. Although buyers value the safety of products, economic realities may limit the strength of this voluntary approach. There is no requirement for buyers to be so food safety conscious that they constrict the supply of produce that they rely on, and price must always be a major factor in a buying decision.
Strengthening the Buyer Driven Food Safety Model through Regulation
In the absence of a regulatory presence, third party auditing firms together with management and the buyers themselves provide the oversight in the buyer-driven model. Third party auditors unlike their regulatory counterparts “inspectors”, do not approve suppliers, enforce standards or decide what products enter commerce. Third party audits provide an assessment of compliance with one of several voluntary food safety standards generally based on FDA guidance documents. While there is much interplay and coordination between the two sectors, third parties act independently of government.
The current trend is for the major wholesale buyers, Albertsons, Wal-Mart, McDonalds, Publix Markets, and other large food retailers to request a third party audit of a produce supplier as a condition of approval. The model needs strengthening because while audits may be thorough and the audit findings comprehensive, as previously explained, buyers make decisions based on factors other than audit results. In the end, the final decision to select or reject a produce supplier rests with the buyer and his needs at the time. Buyers evaluate audit criteria, but also base decisions partly on quality, quantity, and the economics of supply and demand. A complimentary regulatory program would strengthen this model.
While it seems logical that the federal government should administer the program, the State Departments of Health or Agriculture are in a better position than federal agencies to regulate produce. FDA reports it cannot move swiftly enough to meet the current challenges in regulating the nation’s produce supply and questions whether its own regulations will work (7). USDA currently does not have any jurisdiction over on-farm food safety, and experts agree that federal laws would take years to put into place.
Proposed Mandatory State Rules-“The California Produce Safety Action Plan”
In February, 2007, California Senator Dean Florez, introduced “The California Produce Safety Action Plan”, a package of senate bills designed to bring mandatory rules to California produce growing operations for the first time. These bills are in response to the deadly E. coli O157:H7 outbreaks that have hurt the leafy green industry in California. “After 22 E. coli outbreaks associated with leafy greens, we know that market forces have not been strong enough to bring reform to the leafy green industry”, Florez said, during his remarks to the California senate. “For years” he explained, “the federal government through the FDA has been left to writing open letters practically begging the industry to act. None of it has worked” he added, “it’s time that government does its job.” While these bills met with opposition and are struggling to move forward, the structure of the bills provides valuable insight into how environmental health regulations can be structured.
Bills introduced by Sen. Flores in California
The first bill, SB 200, allows the California Department of Health Services (DHS) the authority to effectively manage and protect the public safety in the event of an E. coli outbreak. It includes the authority to-
• Recall, and
• Destroy infected produce
SB 200 also creates the Leafy Green Inspection Program at DHS. Inspectors will inspect farms under this program. DHS inspectors will have the authority to conduct their own investigations and take action to protect public health, including the quarantine of produce.
SB 201 mandates the application of GAP. DHS will act as the gatekeeper and create regulations for the industry to follow.
SB 201 also requires DHS to develop Hazard Analysis and Critical Control Point Plans (HACCP) systems for leafy greens and requires growers to develop a plan for each growing location and to keep records.
SB 202 requires the creation of a trace-back system. This system will require product coding to identify the source of the product all the way to the specific farm where it was grown.
Produce Inspection Duties
If such rules come into practice the regulator tasked with seeking compliance must acquire a high level skill specific to farming operations. The regulator must validate the management controls in place, verify the effectiveness of GAP application, and be able to identify or estimate levels of contamination.
The roles of the inspector would include auditing records, making visual inspections, ensuring farmers meet GAP standards, and performing tests. Specific duties might include:
· Testing of water
· Testing of soil
· Testing of produce
· Prohibiting use of raw manure
· Prohibiting the use of creek water for irrigation
· Prohibiting the use of portable toilets in the fields themselves
· Maintaining buffer zones around various hazards
· Overseeing composting operations
· Approving grazing land set backs
· Septic tank installation approval
· Evaluating Concentrated Animal Feeding Operations (CAFO) set backs
· Testing water sources (ponds / creeks / lakes / rivers, etc.)
· Validating recall procedures
· Verifying trace back and trace forward systems
Florida Tomato Initiative
In Florida, enforceable standards are required in the tomato industry. Florida tomato growers successfully asked our state legislature for regulation. Under Florida Administrative Rule 5Q-6 these measures and inspections will begin this fall. "We want mandatory inspections to bring everybody that handles tomatoes in the state in the loop to comply with food safety," said Tony DiMare, vice president of Homestead-based DiMare companies, one of the state’s largest tomato growers in a story published recently in the Palm Beach Post. "We wanted to take a proactive approach and stay ahead of the curve". The importance of this initiative is underscored by the fact that although Florida was not shipping tomatoes during the early outbreak of this year, the Florida tomato industry lost millions due to fears of potential contamination
The law takes effect before the fall planting season and is under the auspices of inspectors with the State of Florida Department of Agriculture and Consumer Services.. While the largest tomato operations in the state see the advantage of regulation, many of the small and mid-sized growers will feel a serious impact due to new rules covering mandatory washing and temperature controls for products.
Environmental Professionals and Produce Regulations
Environmental health professionals have experience in most key areas important to produce safety. New regulations will require regulators to quickly assimilate knowledge about GAP and apply the principles of GAP to their inspection duties. The FDA guidance documents are a good place to start assimilating knowledge but understanding how the industry applies GAP will take some experience. Determining a grower’s compliance with GAP requires familiarity with Hazard Analysis Critical Control Point (HACCP), especially the process of validating and verifying HACCP systems at all levels of the produce supply chain. The produce industry is actively applying HACCP to growing, harvesting, packing and processing.
Regulators will evaluate and interpret microbial data. To assess the effectiveness of on-farm food safety programs regulators need working knowledge of basic microbiological sampling methods and testing procedures for products, water and soil. Sanitarians will also need to stay aware of current research and emerging scientific findings. They will take on the job of assisting in mitigation of microbiological hazards and need an understanding of how pathogens contaminate produce and how to assess risks. To ensure their own efforts are successful, regulators must base regulatory decisions on sound scientific evidence.
Throughout the history of public health, sanitarians have played an important part in food protection. With experience in so many key areas, environmental health professionals will undoubtedly make a valuable contribution to on-farm-food-safety through regulation. Public health regulation will enhance what the produce industry is doing now, improve its food safety record, and restore consumer confidence in a healthful and safe produce supply.
 “Investigation of an Escherichia coli O157:H7 Associated with Dole Prepackaged Spinach” California Department of Food and Agriculture. US Food and Drug Administration.
 “Food Safety Bills Face First Legislative Test“. Dean Florez. California State Senate.
 “California Leafy Greens Marketing Agreement“. California Department of Food and Agriculture.
 “Assessments Begin for Leafy Greens Marketing Agreement“ News Release. California Department of Food and Agriculture.. April 2, 2007.
 “Guidance for Industry; Guide to Minimize Microbial Food Safety Hazards of
Fresh-cut Fruits and Vegetables“: US Food and Drug Administration. Draft Final Guidance. March 2007. http://www.cfsan.fda.gov/~dms/prodgui3.html
 “Commodity Specific Food Safety Guidelines for the Lettuce and Leafy Greens Supply Chain.-1st Edition“. Produce Industry Publication. April 26, 2006.
 “FDAConsiders Safety Guidelines for Produce” CNBNC report
8-Tomato Growers Push for Regulation“. The Palm Beach Post. April 2, 2007.
My role as a sanitarian aside, the public deserves a safe food supply and industry must do all it can to protect us. Having worked in the safety of agriculture for the last 7 years I can tell you that there has been a lot of change but there is still a very long way to go. Contamination on farms with animal feces, the carrier of E coli and Salmonella, is sometimes very obvious. Water sources are not routinely tested. Worker health and hygiene while improving is still not where it should be. Industry has a shot at self-regulation, but if the produce industry wants to keep health regulators out of their business they need to police themselves a lot stronger than they are currently. The problem is that the need for food, demands in the market place and a shrinking agricultural supply are in the background of this picture. Government must step in not to penalize the industry but to bring basic standards to all operations, both large and small and assist in this effort. Undoubtedly industry self policing must continue, but a bolstering by the government with an effort to weed out the worst conditions is very important to strengthen self-policing. With advent of these very harmful microbes now well entrenched in the food supply a coordinate effort managed by government holds the best solution to protecting public health.