Regulations Dominate Contamination Control in the Food Industry
By Kathleen R. Vail and Myron Struck
Ninety years ago, a 28-year-old novelist, backed by a Socialist weekly publication, spent much of his time in the scum-filled back alleys of the stockyards and slaughterhouses of Chicago researching a novel. Upton Sinclair`s work, The Jungle, became a top seller for generations and set off the first wave of federal reform of sanitary food processing in U.S. history. The truths in the novel prompted federal legislation by President Theodore Roosevelt (the Meat Inspection Act) and turned many Americans into vegetarians.
Over the years, government regulation in many areas of the contamination control industry has become more complex, as the industrial, technological, space and automated revolutions have eclipsed industry. But not so with the meat and poultry industry.
The new regulations
With a stroke of a pen, and some administrative footwork at the U.S. Department of Agriculture, that era is ending. On July 6, President Clinton announced on his weekly Saturday radio address that a plethora of new federal ground rules would dominate the contamination control requirements of the meat and poultry industry. “For all our technological advances, the way we inspect meat and poultry had not changed in 90 years,” Clinton said. “Even though we know that killers like salmonella can only be seen with a microscope, inspectors were still checking on meat and poultry by look, touch, smell.” The Centers for Disease Control and Prevention estimate there may be from six to 10 million illnesses, as well as some 4,000 deaths recorded annually, due to food contamination.
Days after Clinton`s address, U.S. Agriculture Secretary Dan J. Glickman told the American Convention of Meat Processors at its annual convention in Louisville, KY, that the era of neglect in Washington has changed and the protection of the food supply is emerging as a cornerstone issue for the federal government in the 1990s. “The end result will be saved lives and a healthier America,” Glickman said. “Nothing else I`ve done as Secretary of Agriculture can hold a candle to what we`ve achieved together.”
Expanding HACCP
The achievement is based on the expansion of the Hazard Analysis and Critical Control Points (HACCP) system. The system, which is billed by Glickman and Clinton as a “significant shift” in strategy, is opening the door to vast new business opportunities in the field of contamination control. With the development of the computer chip, scientists have long come to believe that a clean environment can lead to purer manufacturing and production processes. As the layers on silicon wafers became thinner and more susceptible to contamination or marring, the environment in which they were conceived needed to become cleaner. The government is now saying the same has become true of the meat and poultry industry.
Oversight of food-processing contamination is shared by the Agriculture Department`s Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA), part of the U.S. Department of Health and Human Services` Public Health Service. The USDA oversees meat and poultry producers. The FDA oversees the rest of the industry, including seafood producers and other food processors.
Launched a decade ago, HACCP was designed to ensure safety in low-acid canned foods. The seafood industry adopted it in 1995. Under the HACCP system, the government is aiming to get out of micromanagement of the private sector. Instead, HACCP calls for industries to set their own purity standards, with the oversight of inspectors and the input of private sector leaders. “Inspectors won`t be there to play regulatory `gotcha`,” Glickman contends. “Our prime concern will be the end result–bringing everyone to the same high standard of safety. How you get there is up to you.” For meat and poultry producers, the plan began with a new round of standards that went into effect in September 1996. Those rules will be phased in slowly, and most packers will have up to three years to comply.
Stopping contamination
Glickman says this “systems-based” approach involves industry developing a plan to end food-processing contamination in the workplace, be it a poultry processing plant or a beef slaughterhouse. The standards are designed to be flexible and tailored to specific industry needs, yet open to clear auditing and review.
Within the poultry processing industry, for example, nearly half of all chicken products processed have salmonella in them, a bacteria that could be lethal if the product is not properly cooked. On the other hand, many other foods have only minor amounts of potentially dangerous bacteria and require less stringent government oversight and controls. The HACCP system is designed to let industry come up with the best practices to bring down contamination levels while remaining competitive. “We`re challenging every meatpacking plant in America to do scientific tests or take other safety precautions at every step of production,” Clinton said. “Companies will have to improve their sanitation procedures. All too often, food is contaminated because simple sanitary rules are not followed.”
All plants must develop, adopt and implement a HACCP plan for each of their processes. Under HACCP, plant owners identify critical control points during their processes where hazards such as microbial contamination can occur, establish controls to prevent or reduce those hazards, and maintain records documenting that the controls are working as intended. Plants will be required to develop HACCP plans based on seven principles articulated by the National Advisory Committee on Microbiological Criteria on Foods: hazard analysis; critical control point identification; establishment of critical limits; monitoring procedures; corrective actions; record-keeping; and verification procedures.
Plants will identify and evaluate food safety hazards that could affect the safety of their products and institute the controls necessary to prevent those hazards from occurring and to keep them within acceptable limits. HACCP systems will be required to cover those critical control points that affect product safety, as opposed to those related to economic adulteration and quality. Every meat and poultry product must be covered by a HACCP plan. Plants will be required to validate their own HACCP plans–that is, ensure they do what they were designed to do.
Verification (making sure the plan is adequate and working on a day-to-day basis) will be the responsibility of both industry and the FSIS. Industry will monitor and verify the performance of the controls in their HACCP plans and maintain records of this monitoring and verification. FSIS will evaluate the HACCP plan`s adequacy and successful operation as part of the inspection process. HACCP plans found by FSIS to be inadequate will have to be corrected or the plant will face regulatory action.
Beyond carcass-by-carcass inspection
Currently, FSIS carries out carcass-by-carcass inspection in slaughter plants, and this will continue under the new rules. However, FSIS will now examine current tasks related to carcass-by-carcass inspection and determine what changes should be made to improve inspection effectiveness and make inspection resources more productive. FSIS is developing 13 generic HACCP models for the major process categories that will be available in final form before plants must begin work on their HACCP plans. These generic models will serve only as illustrations rather than prescriptive blueprints for a specific HACCP plan.
The new USDA regulation has four parts. First, every plant must adopt and carry out its own HACCP plan that addresses all the significant hazards associated with its products. Second, every slaughter plant must regularly test carcasses for generic E.coli to verify the plant`s effectiveness in preventing and reducing fecal contamination. Fecal contamination is the major source of contamination from harmful bacteria like E.coli 0157:H7 and salmonella. Generic E.coli is the best microbial indicator of process control of fecal contamination.
Third, all slaughter plants and plants producing raw ground products must ensure that their salmonella contamination rate is below current “national baseline incidence.” This first-ever regulatory performance standard for a pathogen on raw meat and poultry will ensure real progress in reducing harmful bacteria. Fourth, as a foundation for HACCP, every plant must adopt and carry out a written plan for meeting its sanitation responsibilities. Effective sanitation in slaughter and processing plants is essential in preventing adulteration of meat and poultry products.
The HACCP system will be implemented first in larger meat and poultry plants, with 75 percent of slaughter production to be under HACCP-based process control and subject to salmonella performance standards within 15 months. Small plants have 30 months to comply with HACCP. Plants with fewer than 10 employees or less than $2.5 million in annual sales will have 42 months. The new rules apply to more than 6,200 slaughter and processing plants that operate under federal inspection. The same or equivalent requirements will apply to state-inspected meat and poultry plants and to foreign plants that export to the United States.
The General Accounting Office, which reviews and audits government policies, has looked at the new procedures and concluded the process was on the right track, but that there is no guarantee that food-poisoning incidents will be quickly reduced or eliminated. In a June, 1996 report to Congress, the GAO said: “The government`s role under HACCP will shift from mainly conducting physical inspections to assessing each plant`s safety system record keeping and its effectiveness.” Whether decreased inspections can result in safer food products remains to be seen, congressional auditors concluded. The report criticized the USDA for having too few resources committed to these issues. “When inspectors can reach sometimes more than a dozen plants in a day, they can only skim the surface,” the GAO said. “Serious hazards are missed.”
The GAO testified before Congress on the eve of the Clinton and Glickman announcements. Robert Robinson, the GAO`s director of food and agriculture issues, told the House Government Reform and Oversight Subcommittee on human Resources and Intergovernmental Relations that the “patchwork” of USDA approaches to contamination control still needs to be revamped. Robinson said the USDA`s HACCP requirements for seafood processors differ from an approach used by another part of the USDA for meat and poultry plants. “Because the frequency of inspection is based on the agencies` regulatory approach, some foods may be receiving too much attention, while other foods may not be receiving enough.”
The USDA`s solution, announced several weeks later, was expanded contamination control procedures and the enhancement of HACCP. Industry officials have estimated it will cost from $80 million to $100 million per year to implement these standards, a cost to be borne entirely by industry.
To implement the new HACCP program, the USDA has downsized to 18 regional field management offices that oversee food contamination issues. At the USDA`s headquarters, about half of the organizational units will be eliminated. Meanwhile, a new Office of Public Health and Science has been set up to act as a liaison between the USDA and public health agencies. In announcing the restructuring, Glickman said the unit is designed to upgrade the agencies` scientific capabilities in assessing how safe and clean modern food processing operations really are.
Under the organizational structure envisioned by Glickman, staffers from the Public Health Service can be detailed to the USDA to work with food safety inspectors, potentially increasing the expertise the federal government can bring to bear on con tamination issues. The USDA is establishing what it calls “objective performance standards” for the safe production of cooked beef products, uncured meat products and some partially cooked poultry products. “These proposals reflect our strategy shift from a prescriptive command-and-control system of regulation that can stifle innovation to one that provides greater flexibility and responsibility to industry to produce safe products for consumers,” Glickman said.
To ensure that the new contamination program works, a second new rule will require manufacturers to consider federal standards when building a food-processing plant. The package of new standards is estimated to cost about $80 million to implement, according to one report. Overall, the contamination control industry is expected to spend $2.7 billion.
While HACCP is taking hold in the seafood, meat and poultry industries, the FDA has been testing the procedure with other food processors. Seven companies agreed to take part in a year-long pilot program to implement HACCP plans in certain of their products: Alto Dairy and hard cheese production; Campbell Soup Co. and salad dressing; The Earthgrains Co. and pan breads; ConAgra and flour; Hans Kissle Foods and quiche; Pillsbury and frozen dough; Ralston Foods and breakfast cereal.
The FDA`s role under HACCP is to verify that HACCP programs are effective and are being followed. Verification involves on-site evaluation of a firm`s HACCP system as documented by the firm`s HACCP records. The evaluation determines if all significant hazards are being properly controlled through preventive measures. Data submitted to the FDA during the pilot program will be considered confidential.
Food safety hazards to be controlled in the pilot program are physical objects such as glass and metal; chemicals like animal drug residues, cleaning compound residues, allergens, toxins and pesticides in packing materials, raw ingredients and shipping containers; and microbiological contaminants in post-cooked food and raw ingredients and storage. A central concept in using HACCP is to have employees trained in quality assurance. Most companies in the pilot program reported that their employees had little formal training in this area. HACCP also requires a team approach to quality assurance for contamination controls.
Upgrading QA programs
In June 1996, the FDA Center for Food Safety and Applied Nutrition released an interim report of observations and comments from participating companies. An important issue in developing a HACCP program, according to the report, was determining how HACCP should be integrated with existing quality assurance programs. One pilot participant commented: “HACCP is an important management tool and has been integrated into all phases of the operation. If every QA system outside of HACCP failed, we would still have a safe product. If HACCP failed, we would not. The other QA systems cannot support safety.”
Another company stated: “HACCP is really just a spin-off of a previously used control concept. With respect to controlling physical hazards, there is little difference from previously used controls, except that HACCP requires more stringent monitoring, documentation, and record review, as well as follow-up documentation.” Another firm reported: “We learned from the pilot that we did not have a clear document describing hazards. In the past, we relied on product specifications. Now, we are developing a hazard analysis document that clearly distinguishes and communicates to our plant employees the hazards that are being controlled.”
The training and addition of quality assurance personnel looms as one of the major new job opportunities within the food-processing industry. Another area is simple training of personnel in the procedures that need to be employed to meet HACCP standards. According to a report by the Center for Food Safety and Applied Nutrition, training manuals could be of major assistance. “One firm has a sophisticated corporate train-the-trainer-type program that provides different levels of HACCP training to employees depending upon their responsibilities,” the report states. “All employees receive at least a basic introduction to HACCP training.” Among the challenges: ensuring that training materials are available in the native language of the employees, and that a feedback system is in place for employees to spot and report problems.
As HACCP continues to be tested, food processors continue to be regulated by the FDA`s Current Good Manufacturing Practices (CGMPs) in Manufacturing, Packing or Holding Human Food. FDA plant inspectors ensure that companies are following these CGMPs. The schedule of inspections depends on the relative safety or danger of the product, according to Judy Foulke, a spokeswoman for the FDA. For example, bottled water plants, which are heavily regulated but have few instances of contamination, will be on an inspection schedule of once every four years. If companies aren`t following any part of the CGMP, government inspectors could require them to recall their products. In extreme cases, the FDA could petition the Justice Department to close the offending plant.
There is a set of overall CGMPs that covers personnel, plants and grounds, sanitary operations and facilities, equipment, processes and controls, and warehousing and distribution. For example, employees may not have open lesions if they come in contact with food; they must wear outer garments that protect against food contamination; they must wear gloves if they are handling food, and remove all unsecured jewelry and other objects that might fall into food, equipment or containers. n
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U.S. Agriculture Secretary Dan J. Glickman