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Food Safety and Inspection
Service United States Department of Agriculture Washington, D.C. 20250-3700 |
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Food Safety and Inspection
Service United States Department of Agriculture Washington, D.C. 20250-3700 |
Remarks delivered by Carol M. Seymour, Assistant Deputy Administrator, District Enforcement Operations, before the HACCP Implementation Meeting, December 16, 1997, Washington, DC
Thank you for coming today. At this point we would like to turn our attention to the topic of enforcement of the HACCP regulations and explain the concepts that underlie the approach that FSIS intends to take. The formal remarks will cover about 20 minutes, and then we will be happy to receive your comments and answer your questions.
The conceptual shift embodied in HACCP, in which industry must assume its proper responsibility for food safety, enhances the importance of an effective enforcement program. Last year, as FSIS introduced Sanitation SSOP’s and other components of the pathogen reduction regulations, we described new concepts for enforcement that would complement the rule and provide the level of public confidence necessary to accomplish a fundamental shift in approach to food safety. We also described how the new organization of FSIS and the changing roles of inspectors and compliance officers would support effective implementation of the rule and allow both FSIS and the regulated industry to focus on their respective responsibilities for ensuring that food is safe. As we move toward the January 1998 HACCP implementation date for large plants, it is useful to review these concepts, assess how they have been applied in the past months, and consider what adjustments will be both possible and appropriate as plants implement HACCP.
The first new concept to consider is the changing roles of the regulated industry and the inspection and compliance functions of FSIS. While the Pathogen Reduction and HACCP regulations provide enormous flexibility for the industry to develop and implement innovative measures for producing safe foods, they also impose clear and unequivocal responsibilities for preventing contamination by pathogens and other hazardous substances. This clearly defined role for the industry—accountability for food safety—was accompanied by a change in the roles of inspectors and compliance officers—to verify industry practices and to take enforcement actions when plants’ control systems fail to meet regulatory requirements.
Another concept introduced by the regulations is the linkage between a plant’s ability to control processes and the eligibility of products to bear the marks of inspection. Under traditional inspection, the finding that product is not adulterated—and thus eligible for the mark of USDA inspection—is based on FSIS inspectors examining products for evidence of contamination. Under the new regulatory framework, this finding will be made based on FSIS concluding that sanitation and process control systems operated by plants are preventing adulteration. If products are not produced under appropriate control systems, as evidenced by the production or distribution of unsafe products or by continuing system failures attributable to the same root cause, FSIS will act to withhold the mark of inspection until plants can assure both corrective and preventive actions are in place and effective.
A third concept that provides for clear understanding of new enforcement processes is the changing significance of plant actions to address deficiencies that are detected by inspectors or plants. The traditional inspection program was based on the concept that inspectors find deficiencies and plants correct them. This "find and fix" mentality did little to encourage preventive measures, because it created the perception that it was only necessary to remedy the problems that inspectors found. Under the new system, plants are responsible for finding deficiencies and for using the information they gain when they check their systems to strengthen preventive process controls. As a result, plant actions to detect and assess deficiencies to determine their causes are viewed as evidence of proper functioning control systems. FSIS verification includes a review of these actions through observation and records review to determine whether systems are functioning. Thus, as long as plants maintain their systems properly—including detecting, documenting and correcting deficiencies—there is no need for FSIS to take enforcement action. By contrast, a pattern of the same or similar deficiencies occurring again and again will lead FSIS to conclude that the plant does not have in place the required process controls. This type of deficiency is very serious and leaves the agency little choice but to withhold the marks of inspection.
A fourth concept has to do with how FSIS uses its resources to hold plants accountable for ensuring the safety of foods they produce. The new FSIS organization integrates inspection monitoring resources and enforcement resources into a unified District structure and assigns new roles to FSIS compliance officers. In the past, compliance officers were primarily responsible for products in distribution channels and generally contacted inspected plants only when following up on violations that involved product that had already been distributed in commerce. The new organization enables FSIS to use the training and expertise of compliance offices to assist inplant inspectors in documenting failures of plant control systems and helps to ensure appropriate due process when enforcement actions are needed. A team approach to enforcement actions also helps ensure that actions are consistent and fair and that plants receive appropriately documented notice of violations and an opportunity to comply with the regulations. Through close integration of resources, FSIS can respond quickly to situations in which plant operations have been interrupted and determine whether corrections have been effective or whether suspension of inspection is warranted.
A related concept emphasized as we introduced the new regulations last year involves the rights of plants to receive notice of alleged violations and the right to appeal agency actions. FSIS believes that appeals of legitimate disagreements are both necessary and appropriate. Plants are encouraged to appeal inspector findings at the earliest point in the process. Some plant officials may dispute findings but let them go unchallenged until an enforcement action based on the findings is under way. Similarly, plants may disregard inspector findings which they mistakenly believe are erroneous, allowing needed corrections to be delayed unnecessarily.
Last year we solicited comments and promised to consider revising our supplementary rules of practice. Obviously, we have not issued new rules, but we do plan to have a proposal soon. In the meantime, we will continue to apply existing rules and provide actual notice of proceedings and appeal channels as needed when bringing administrative complaints.
Since January 1997, FSIS has undertaken a systematic process to enforce requirements for developing and maintaining sanitation SSOP’s, monitoring generic E. coli, and assuring compliance with "zero fecal tolerance" standards. Similar enforcement protocols have also been developed to be applied in other regulatory contexts such as preparation of fermented sausages as data sets are completed, adherence to Salmonella performance standards. As new regulatory initiatives are developed, these enforcement protocols are likely to become the standard model for FSIS enforcement actions for plant non-compliance.
As discussed previously, each model is based upon a clear mandate that establishments implement control systems that assure food safety by preventing contamination and adulteration. FSIS inspection tasks and verification assessments are designed to measure how well plants prevent problems. FSIS assesses any problems that do arise in two ways. First, FSIS determines what, if any, action is needed to prevent shipment of adulterated products. Second, FSIS determines whether the plant control systems are adequate to allow continued use of the marks of Federal inspection. FSIS has stressed proper documentation of deficiencies for two reasons—first, so plants have adequate notice and opportunity to comply and, second, to establish the basis for enforcement measures if necessary to address systems failures.
Most enforcement actions to date have been effective in addressing plant problems at early stages, and thus it has not been necessary for FSIS to intervene to withhold the marks of inspection for any extended period. In many respects, these enforcement actions have been similar to those that have been in place for over 90 years. Inspectors use authority to retain and condemn contaminated products and reject or "tag" areas of the plant or pieces of equipment much like they always have. However, the new regulations call for steps that go beyond these product control actions to address plant systems, if the plants are failing to prevent reoccurring problems.
Although there are numerous variations depending on the particular circumstances, the protocol for enforcement actions includes the following general steps. First, inspectors in charge (IIC’s) through a Non-Compliance Report provide notice to plants when requirements of the regulations are not being met. Second, IIC’s are instructed to notify the plant management officials that the marks of inspection are being withheld from products and to contact the District Office. Third, the District office sends a compliance officer to the plant to further document the situation.
It is important to note that at this and any subsequent point in the process the plant is encouraged to quickly respond to the information that the IIC has provided about non-compliance. We expect that compliance officers should be on site within a few hours and have instructed them to complete their reports as soon as possible. Our experience to date has shown that these situations are resolved quickly, if plants are prepared to expeditiously file any appeals or present any proposed corrective or preventive actions to the District Office while this documentation is being completed.
The next step in the process is for the District Office, in conjunction with headquarters District Enforcement Operations, to review the compliance officer’s report and any written or oral information submitted by the plant. Typically, plants that have reached this point have not fully appreciated the need to be accountable for their process controls and ask FSIS to tell them what to fix. District Offices have provided plants with guidance on what is necessary to avoid a continued suspension of inspection by explaining that the plant should:
If plants are successful in addressing these matters, FSIS will issue a Notice of Suspension Held in Abeyance. In effect, this notice says that FSIS has concluded that the plant systems have failed, but that the plant has acknowledged the problem and developed a plan to prevent its reoccurrence. Typically, we have held these abeyances for several weeks or months, to verify that the proposed corrections and preventive measures are made and are effective. Once the verification occurs, plants are issued a warning letter to close out the file.
District Offices will issue a Notice of Suspension covering all or parts of a plant’s operations when the plant fails to respond or fails to adequately address the root causes of the non-compliance. At this point, plants may appeal or resubmit proposed action plans. Although, to date, none of the actions has progressed beyond this stage, the next step in the enforcement protocol would be a complaint to withdraw inspection. If the plant is making a good faith effort to correct problems, we would wait to file the complaint to withdraw inspection and keep the suspension in place. Otherwise, we would proceed with the complaint quickly -- as soon as we conclude that the matter cannot be resolved without a hearing before an administrative law judge.
Through mid November 1997, of the total 6,496 plants operating under Federal inspection, 6,480 plants had established a level of compliance that did not require an FSIS withholding or suspension action. FSIS opened 16 cases as a result of District Office findings that plants had failed to develop or maintain effective SSOP systems. Five cases were closed with a letter of warning after inspectors verified that the plant had completed corrective action or after the plant voluntarily stopped operations requiring Federal inspection. Eleven cases are now pending, with suspension of inspection held in abeyance. In none of these cases has it been necessary to file a complaint for withdrawal of inspection.
Numerous other situations are now under review, as the compliance and inspection team apply a pro-active approach. The pro-active approach involves a team assessment of documentation in plants that have begun to accumulate a history of non-compliance. FSIS is encouraging field managers to openly discuss these situations with plants and to gain commitment to avoid the continued pattern of sanitation and other deficiencies before enforcement actions are necessary.
Before closing these remarks on enforcement, we should turn our attention to another concept introduced last year which concerns the growing importance of truthful and accurate recordkeeping by meat and poultry plants. Adequate records are necessary for both the plant and inspector. Plants need records to verify that their control measures have worked and that their products are safe and wholesome, before deciding to ship them in commerce. Inspectors rely upon both "hands on" observations and reviews of plant records to assess whether systems are functioning properly. In the absence of adequate records, we cannot conclude that products are being produced safely -- that critical controls are functioning and performance standards are being met. Plants that maintain false or deceptive records to avoid inspection oversight are in jeopardy of criminal prosecution. FSIS enforcement activities, now and in the future, will give priority to cases involving incomplete or fraudulent records.
In closing, it is essential to stress that none of these enforcement actions is undertaken lightly. They represent an enormous drain on agency resources and potential market disruptions that affect not only the plant that is under scrutiny but also their suppliers and customers. However, the alternative of continuing to allow products to be produced without adequate food safety controls would have far more serious consequences. FSIS is committed to a systematic process, with adequate supervisory overview, to ensure that there is nationwide consistency and fairness to both plants and consumers. This process provides plants with notice of non-compliance that forms the basis for enforcement action, an opportunity to appeal and voice disagreements, and time to propose corrective actions before FSIS proceeds with the appropriate enforcement measures.
We hope that this discussion has been informative, and we would be happy to hear your comments and answer your questions.
For Further Information Contact:
FSIS Food Safety Education and Communications Staff
Public Outreach and Communications
Phone: (202) 720-9352
Fax: (202) 720-9063
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