"OUNCE OF PREVENTION" IS CURING U.S. FOOD ILLS

Processors and importers must use FDA's new hazard analysis system

Helen Gillespie

An overhaul of the nation's food safety regulations has been under way since 1993. Now, scientific technology will play a greater role in food safety inspection methods and preventive controls. New safety standards for seafood, meat, and poultry products have replaced archaic methods used since the early 1900s, and more measures are under review.

Of critical significance to this regulatory push is the recognition that microbial contamination, particularly in the form of new pathogens, is the greatest concern in food safety. Bacteria such as E. coli and Salmonella enteritidis are more widespread - the number of FDA-regulated products recalled for life-threatening microbial contamination has increased fivefold, from seventy-nine in 1988 to 378 in 1995 (1).

According to a 1994 report, foodborne microbial pathogens cause an estimated 6.5 to 33 million illnesses and up to 9,000 deaths annually, and hospital stays cost at least $3 billion annually. The estimated total costs of foodborne illness are at least $5.6 billion (2).

With the expansion of the global marketplace into new sectors, the food industry has likewise grown, both in the amount of domestic food manufactured and in the number and kinds of foods imported. Finally, the resource constraints under which the US Food and Drug Administration (FDA) and state and local agencies now operate have severely affected the government's ability to perform safety inspections. FDA inspections have decreased from 21,000 per year in 1981 to 5,000 per year in 1996, meaning that FDA is now inspecting food processing plants, on average, once every ten years.

To offset these inspection constraints, the new regulations require food processors to take responsibility for preparing safe food and monitoring their own processes. In particular, the processors are expected to use a Hazard Analysis Critical Control Points (HACCP, generally pronounced "hassip") system that identifies the areas where food could become contaminated during production processes and then monitors targeted control points to prevent such risks.

"Fifty years ago standard methods were virtually nonexistent," stated John H. Silliker, research scientist and founder of Silliker Laboratories, at the 111th AOAC International Annual Meeting in San Diego, CA, in September 1997. "Individual laboratories or analysts had a quasi-proprietary attitude toward their procedures. The number of known foodborne pathogens has increased and, fortunately, validated methods have evolved. Increased international trade, together with domestic programs, such as the HACCP and the Pathogen Reduction Program, require that these methods be utilized by competent laboratories, using statistically sound sampling plans related to the hazard severity."

WHAT IS A HACCP?
First used by the food industry in the production of safe food for US astronauts, HACCP techniques have been used successfully for processing low-acid canned foods for many years. The HACCP regulations being launched are part of the Hazard Analysis Critical Control Points and Pathogen Reduction Rule, which is, in turn, part of the overall Food Safety Initiative launched in 1993.

In 1995, FDA issued the final rule on 21 CFR Part 123, which governs the implementation of the seafood HACCP that became effective 18 December 1996. In July 1996, the US Department of Agriculture (USDA) issued similar rules for the meat and poultry industry. On 26 August 1997, these rules were followed by the announcement that fruit and vegetable juice producers must initiate a HACCP program. Fruit and vegetable producers and importers are also now receiving attention.

The new rules work side by side with existing regulations. Under HACCP, FDA's role is to verify that HACCP programs are effective, but not to define what elements a HACCP must contain. Verification involves on-site evaluations of the firm's HACCP system to determine whether all significant hazards are being properly controlled through preventive measures.

A HACCP system varies from plant to plant and product to product. It is preventive in nature, rather than dependent on end-product testing. It identifies and monitors critical points in the production process to prevent contamination where it is most likely to occur. These critical control points are tested for contaminants using microbiological detection techniques.

Once critical control points are determined, the organization then designs safety steps to prevent or detect errors and deal with problems before product safety is compromised. In-process testing is used, where samples are pulled from the production line and tested against specifications. If all samples fall within specifications, the lot or batch is approved. If any samples are outside specifications, more samples may be tested and corrective action can be taken.

DEVELOPING A PROGRAM
There are seven key steps defined by FDA that a producer or importer should take when developing a HACCP plan (see sidebar). Of these steps, the most important is to conduct a hazard analysis to determine whether there are food safety hazards that must be controlled. If such hazards do not exist, then a HACCP plan is not necessary. If there are food safety hazards that must be controlled, then the food processor must have and implement a HACCP plan. FDA will expect to review the food processor's written hazard analysis in either case.

Often the hardest part is defining a true hazard as opposed to a theoretical hazard. Likelihood of occurrence is the deciding point, so a risk assessment should be performed.

"The difference between a hazard and a risk is that just because you have a hazard doesn't mean you have a risk," stated William Jolly of the New Zealand MAF Regulatory Agency during the AOAC meeting. "Keep in mind that the difference between a drug and a poison is merely a dose. Because food safety is dependent on pre-harvest controls, this places much of the burden on the farmer rather than on the lab. Therefore, the producers or farmers should be educated in the chemistries of food safety."

This statement is particularly true in that critical control points can occur both inside and outside the processing plant, including the production of the raw materials that the food processor uses. These raw materials can have a significant impact on the safety of the end product, as evidenced by the 1996 E. coli incident in which Odwalla (Half Moon Bay, CA) fruit juices were contaminated not during processing, but by the apples used to make the juice.

Another area that may cause difficulty concerns the corrective actions that a processor must implement and verification records that must be maintained. FDA will expect to see records for such activities. The final important issue is determining how HACCP should be integrated with existing quality assurance programs. Generally, HACCP requires modification of the previous program but not something completely new, because the systems and controls are likely to be similar.

Although HACCP will require changes in food processing techniques to ensure that test results will be in line with requirements, education and training of the various participants throughout the food processing chain - from production to distribution - will play a key role.

Lack of compliance with HACCP requirements does not mean that FDA will automatically seize products produced under a deficient HACCP system. If FDA determines that a HACCP plan is unacceptable or inadequate, the food is considered adulterated. Deficiencies are then evaluated on a case-by-case basis, with the response dependent on the findings.

In deciding what regulatory action to take when noncompliance occurs, FDA will look at the likelihood that the deficiency could lead to a public health problem. Minor violations that are not likely to affect public health will probably result in verbal or written notification to plant management by the inspector. Warning letters, seizure, injunction, and prosecution will be used for more serious violations. In regard to clerical errors or errors in HACCP records, it is unlikely that the inspector will take regulatory action.

TO SIDEBAR: Steps In Developing A HACCP Plan

What is important to remember is that not only will the adequacy of HACCP plans and control points be evaluated, but also whether they are consistently implemented.

TAKING THE INITIATIVE
On 18 December 1996, FDA's seafood HACCP went into effect; it is estimated to prevent 20,000 to 60,000 seafood poisonings a year (3). It applies to all domestic commercial processors of seafood products, including repackers and warehouses. Imports also fall under the seafood HACCP, in that all overseas processors shipping product to the US must meet the same requirements. In addition, US importers are now required to develop and implement HACCP plans, which must include copies of the HACCP plans of their non-US processors. As a result, not only must importers have a domestic HACCP plan, but those plans must also describe what is being done to ensure that seafood products being brought into the US are in accordance with non-US processor HACCP plans. Importers will need to provide assurance that the non-US processor's HACCP plans were working effectively when the product was produced by obtaining third-party certification or HACCP or sanitation records.

On 26 August 1997, FDA announced a HACCP strategy to increase the safety of fresh juices - specifically, to eliminate the existence in fresh juice products of pathogenic microbes such as E. coli 0157:H7. Under this proposal, some or all food processors that manufacture juice products would be required to adopt HACCP safety programs. As an interim measure, FDA has recommended that in the absence of a validated HACCP plan, fresh juice companies should place warning labels on unpasteurized juice as a voluntary public health service to their customers. Once the fresh-juice HACCP proposal becomes final and manufacturers have adopted individual HACCP plans, the labeling requirements may be rescinded.

On 2 October 1997, the White House announced plans to extend the Food Safety Initiative to imported and domestic fruits and vegetables, with the goal of having a program in place within one year. In particular, the proposed legislation will require FDA to "halt imports of fruits, vegetables, or other food from any foreign country whose food safety systems and standards are not on par with those of the US. This legislation, which will be similar to existing law requiring the USDA to halt the importation of meat and poultry from such countries, will enable the FDA to prevent the importation of potentially unsafe foreign produce."

This initiative will provide enhanced FDA oversight for imported food, start the development of guidance on good agriculture and manufacturing practices, and ensure the improvement of monitoring and inspection activities abroad. Along with the import inspections, FDA will initiate a system for certifying and accrediting private laboratories, authorizing such accredited labs to test samples of food products for contaminants. The accredited labs would then provide the service to food processors wishing to demonstrate that their products meet applicable federal standards.

In the future, industry can expect to see more coordination between the government agencies involved in food safety as well as an enhanced infrastructure for foodborne illness surveillance and coordination. The emphasis on food safety continues to build momentum as more high-risk foods are included under the banner of the Food Safety Initiative. In the near term, HACCP regulations should be proposed for eggs and egg products. The HACCP system is the key to ensuring the ability of industry to address the regulations and satisfy the initiative.

REFERENCES

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