Juice incident may spur action by government for cleanrooms in food processing
By Myron Struck and Kathleen Vail
It was a sobering moment for Greg Steltenpohl. As the 42-year-old chairman of Odwalla Inc., Steltenpohl wowed Wall Street with his mission to promote social and environmental endeavors as part of his company`s manufacturing goal of producing consumer beverages. Odwalla had been touted as the Ben & Jerry`s of the juice industry. Revenues and public interest was up, and the Half Moon Bay, CA-based company was riding the high wave.
But in November 1996, Steltenpohl was far from home, in Greeley, CO, watching Chad and Christy Gimmestad bury their only child, 16-month-old Anna. She had died after the toddler drank from a batch of Odwalla apple juice infested by E. coli, a toxic bacteria. Sixty others, many of them children, became severely ill.
“I`m not trying to sound like an altruist, because there certainly is a business rationale to making sure your product is safe,” he later told USA Today. Steltenpohl recalled $3.8 million in apple juice products, then spent $1 million to improve his manufacturing capabilities. Although he wasn`t required to, Steltenpohl also chose to add a cleanroom.
Odwalla made the improvements as part of its effort to implement the critical safety measures that the Food and Drug Administration intends to require for the rest of the fresh juice industry under the Hazard Analysis and Critical Control Program, or HACCP.
“As a company, we have learned a lot and are proud of the world-class HACCP program we have developed,” Steltenpohl said in a statement. “HACCP is expensive and time consuming, but it`s also our responsibility. We strongly urge the other companies in this industry to begin work, with the FDA`s guidance, on developing their own plans for HACCP.”
Clinton launches new initiative
President Bill Clinton reflected back on Odwalla`s plight in his Jan. 25, 1997, radio message to the nation when he announced a new, nationwide food safety initiative.
“Nothing is more important … than seeing to it that Americans live in a world with clean air, safe food, pure water,” Clinton said. “That`s why I was so concerned by what happened [in Colorado]. Apple juice contaminated with a deadly strain of E. Coli bacteria reached supermarket shelves. More than a dozen children, some as young as 2, were hospitalized, and one child died.”
While Clinton was ready to use the Odwalla incident as a peg for a national food safety initiative, the Food and Drug Administration has been reluctant to take follow-up regulatory steps requiring cleanroom technology to be part of the manufacturing mode du jour. The Food Safety Initiative that was launched first brought together disparate federal agencies with stake in food production and handling: Agriculture Secretary Dan Glickman, Health and Human Services Secretary Donna E. Shalala and Environmental Protection Agency Administrator Carol M. Browner.
Joint approach sought
“Recognizing that food safety is not simply a responsibility of the federal government, the President directed us to work with consumers, producers, industry, states, universities and the public to identify additional ways to improve food safety through government and private sector action, including public-private partnerships,” the three cabinet members said in a joint statement. The Food Safety Initiative, they said in a message to the food processing industry, “reflects the current thinking of our food safety experts. But we recognize that you and other constituencies may identify other issues or approaches that should be included in the initiative. We encourage you, then, not only to think critically about the [initiative], but to bring other issues that you may have [forward]. This is only the beginning of the process.”
While President Clinton called for using “cutting-edge technology to keep our food safe and to protect our children from deadly bacteria,” the Food Safety Initiative plan adopted a more cautious approach — calling only for the continued expansion of HACCP.
National Food Processors Association Vice President Dane Bernard was quoted as saying in one report that the new government approach spells out the industry requirements for food safety much more clearly than before.
“The industry`s response has been mixed,” Bernard said. “Any change can cause upset. And, yes, these new regulations will cost, and yes, those costs will be passed on to consumers.”
Where the contamination comes from
The Food Safety Initiative takes the approach that foods may become contaminated “during processing due to malfunctioning or improperly sanitized equipment,” among other problems, such as rodent and insect infestations, misuse of cleaning materials or improper storage.
The threats from contamination range from salmonella, a microbial pathogen that can cause diarrhea and systemic infections and may be fatal to susceptible persons, to campylobacter, a bacterium that is frequently identified as a cause of acute infectious diarrhea. Other potentially dangerous contaminants in food include the infamous E. coli O157:H7, a particularly dangerous type of bacterium that causes hemorrhagic colitis; parasitic protozoan Cryptosporidium parvum and toxoplasma gondii; and Norwalk virus. Each earned separate mention as a target of concern in the presidential initiative.
Stepping back
The current system of protecting food avoids the question of using cleanrooms for any purposes. Food processing, for foods other than meat, poultry, and egg products (except shell eggs), is regulated by the Food and Drug Administration. Most other food products are regulated by the Agriculture Department. Waterborne contamination is monitored by the Environmental Protection Agency. Each entity is focused on using the best, state-of-the-art technology without demanding a specific methodology.
While industry is happy with having discretion, that is also an area where the problems emerge. The FDA has cut back on its inspection teams at the same time, and there has been a quantum growth in food processing facilities. Food imports are booming too, making pricey, special international fare a potential health risk. Meanwhile, the federal government and state governments have increasingly limited resources available to monitor food safety.
The Food Safety Initiative is designed to focus attention on the most critical, or risky, problem areas and allow industry to adopt government sanctioned HACCP guidelines to resolve the problems. A central area of concern to the initiative focuses on the limitations of bioscience in controlling contaminants. “Foodborne pathogens are increasingly overcoming time-tested controls, such as heating and refrigeration, and are developing new virulence and new ways to evade our immune defenses,” the Food Safety Initiative report states. According to the initiatives` study team assessment, the current thinking is that effective control of foodborne pathogens requires that “prevention be targeted at high-risk foods and at high-risk points in their production and distribution.” The study says that “interventions ideally are guided by risk assessment, for which all too often we have insufficient data. Research is needed to support HACCP implementation, to enable verification that critical control points in HACCP systems are working, and to target the data gaps that hamper risk assessment.”
Food safety targets
To amplify the current bioscience limitations, a set of challenges has been brought forward by the Food Safety Initiative agency team, including the goal of developing improved detection methods, greater understanding of antimicrobial resistance and antibiotic drug resistance, and the increased use of prevention techniques.
In this area, the door may be open to the adaptation of cleanroom technologies, but, as in the case of Odwalla, they may be voluntary rather than mandated. The targeted areas under study include:
Develop new disinfection methods and equipment and systems modifications for processing and production plants, and wholesale and retail outlets.
Develop new methods of surface decontamination of fruits, vegetables, meat, poultry.
Develop heat-based and/or other disinfection methods for seafood, meat, eggs, produce, and animal feeds.
Develop new methods to reduce or eliminate contaminants from animals and plants before slaughter or harvest.
In each area, the government could come in and solidify an argument that using cleanrooms, or a particular technology, is the best way to meet current safety guidelines, or attain an HACCP goal. So far, it hasn`t.
“Scientists and other food safety experts have concluded that the most effective and efficient mechanism for assuring that food processors identify and control hazards that could threaten food is the application of the HACCP concept of built-in preventive controls,” the Food Safety Initiative report states.
Step one: The seafood industry
The FDA has begun to implement HACCP for the seafood industry, and the Agriculture Department is overseeing the implementation of HACCP for the meat and poultry industry. The government is also working on a rule for egg processing plants.
“If HACCP is to be an effective program for ensuring that food processors have modern, state-of-the-art food safety procedures in effect, FDA must improve its inspection capabilities, so that the highest risk food plants (such as seafood) are inspected at least once per year,” the report states. “To maximize the joint federal/state role in inspections, development of new partnerships with the states may be considered, that focus on coordinating the inspection coverage and preventing duplication of effort.”
It`ll take money
In May, Vice President Al Gore — who has played ring-leader in the effort to shape the program — followed up on the presidential declaration and the Food Safety Initiative by announcing a five-point strategy and calling for $43.2 million in new funding. That money, now under review on Capitol Hill, would include $8.5 million that would be used by the FDA to expand the HACCP. The latest plan continued to push the edges, with Gore calling on increased development of “preventive techniques” as part of the initiative.
“This administration is using the most modern science and a common-sense approach to increase the safety of our nation`s food supply and protect the public health,” said Gore.
By expanding the concept of HACCP, Gore`s announcement moved the government closer to specific involvement in cleanroom technology, where appropriate, as a control device for potential food contamination. In HACCP, the manufacturer is called upon to develop a plan to identify points where contamination is likely to occur.
Under HACCP-based regulatory programs, there is a delineation of responsibilities between industry and regulatory agencies: Industry has the primary responsibility for the safety of the food it produces and distributes; the government`s principle role is to verify that industry is carrying out its responsibility, and to initiate appropriate regulatory action if necessary.
The Gore strategy suggests new research initiatives to “develop preventive technologies, ranging from new production techniques, to disinfection and food-processing techniques to reduce levels of pathogens.” To achieve its goal, the government plans to select one, or more, specific foodborne pathogens and develop a risk assessment. Then, the goal is to find out how food can become contaminated during production, processing and distribution, and recommend solutions.
The first measure of how industry-based controls under HACCP are working will be told next year, since seafood processing will be the first major industry component to come under its regulatory control in December. Meat and poultry will be covered by HACCP requirements by 2000, depending on the size of the facility.
Myron Struck and Kathleen Vail are freelance writers specializing in regulatory issues. They are based in Alexandria, VA.
Congressional legislation could impact medical devices
A bill working its way through Congress could have some impact on the way good manufacturing practices are used by the private sector to manufacture medical devices and might result in new Food and Drug Administration requirements.
The bill, S. 830, passed the Senate this summer after prolonged debate. It calls for changes in the oversight of manufacturing processes and facilities under the FDA`s purview.
“Innovations are sought to reduce impurities, increase yield, reduce the complexity and time required for manufacture, eliminate equipment, automate procedures, increase stability and otherwise to improve the drug and reduce its cost,” according to a Senate report on section 614 of the legislation.
Currently, the government imposed strict standards on industry not to change approved manufacturing processes for the pharmaceutical and biotechnology industries without sanction.
Under current law, the FDA requires a supplemental application from the manufacturer for manufacturing changes. For biologic products, the FDA generally requires additional testing. In both cases, improvements to manufacturing processes could be delayed due to government red tape.
The Senate report on the bill — titled the Food and Drug Administration Modernization and Accountability Act of 1997 — acknowledges that the impact of the FDA policy on the pharmaceutical and biotechnology industry “has been substantial,” and in some cases resulted in U.S. industries taking their work abroad, where the requirements are more attuned to making rapid manufacturing changes.
“The development of new technology, the public health and pocketbook have all suffered,” the Senate report states.
Under the new legislation, still facing House consideration this fall, limitations will be placed on the kind of manufacturing changes that require supplemental applications to those that would “adversely affect” the identity, strength, quality, purity, and potency of a drug.
The FDA has the responsibility to draft new federal rules that would outline which types of manufacturing changes can be “made at will,” with only a notation in an annual report to the FDA, and which require more extensive documentation or approval. The changes, under the Senate version of the bill, will go into effect 24 months after approval, giving industry and the FDA time to draft and implement the rules and a chance for industry to respond.
Another section of the bill (Sect. 601) addresses minor modifications to a manufacturing process, specifically calling on the FDA to “permit developmental changes in devices (including manufacturing changes) in response to information collected” during the investigation of good manufacturing processes.
In a December, 1996, article published in FDA Consumer, an in-house publication of the agency, the director of the center for devices and radiological health admitted that there were too many delays and foot-dragging in medical device reform. The director, D. Bruce Burlington, M.D., said that the FDA retains the requirement to ensure that medical devices are “safe and effective,” and the emphasis of the self-imposed reform of the process is focused on the use of good manufacturing processes. — KV & MS