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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 |
Key Facts: HACCP Final Rule
Revised January 1998
The Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems; Final Rule embodies a conceptual shift in enforcement that requires industry assume its proper responsibility for food safety. This conceptual shift enhances the importance of an effective enforcement program. In 1997, as FSIS introduced Sanitation Standard Operating Procedures (SSOPs) and other components of the pathogen reduction regulations, new concepts for enforcement were formulated by FSIS that complement the rule and provide the level of public confidence necessary to accomplish this fundamental shift in the approach to food safety.
To 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, FSIS was reorganized and the roles of inspectors and compliance officers were changed.
The first new concept addresses the changing roles of the regulated industry and the inspection and compliance functions of FSIS. The Pathogen Reduction and HACCP regulations provide enormous flexibility for the industry to develop and implement innovative measures for producing safe foods. The regulations also impose clear and unequivocal responsibilities for food safety by preventing contamination by pathogens and other hazardous substances. Consequently, the roles of inspectors and compliance officers have changed to those of verification of industry practices and taking enforcement actions when a plant’s control systems fail to meet regulatory requirements.
Second, there is a linkage between a plant’s ability to control processes and the eligibility of products to bear the marks of inspection. The new regulatory framework is based on FSIS’s strong belief that sanitation and process control systems operated by plants prevent 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, 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 is the changing significance of plant actions to address deficiencies that are detected by inspectors or plants. Plants are responsible for finding deficiencies and for using the information they gain when they check their systems to strengthen preventive process controls. FSIS verification includes a review of these actions through observation and records review. 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 will lead FSIS to conclude that the plant does not have in place the required process controls, leaving the Agency little choice but to withhold the marks of inspection.
The fourth concept addresses how FSIS uses its resources for ensuring the safety of foods produced by inspected plants. The new FSIS organization integrates inspection monitoring resources and enforcement resources into a unified District structure. This new organization enables FSIS to use the training and expertise of compliance officers to assist other inspectors in documenting failures of plant control systems. It helps to ensure appropriate due process when enforcement actions are needed. This team approach will ensure that actions are consistent and fair and that plants receive appropriately documented notice of violations, as well as an opportunity to comply with the regulations. Through close integration of resources, FSIS can respond quickly to noncompliance situations in the plants.
A related concept 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.
Since January 1997, FSIS has undertaken a systematic process to enforce requirements for developing and maintaining SSOPs, verification of 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.
Although there are numerous variations depending on the particular circumstances, the protocol for enforcement actions includes the following general steps:
1. Inspectors-in-charge (IIC’s), through a Non-compliance Report, provide notice to plants when requirements of the regulations are not being met.
2. 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.
3. The District office sends a compliance officer to the plant to further document the situation.
The plant is encouraged to respond quickly, either by appeal or by preventive or corrective actions.
Continued noncompliance will demonstrate that the plant does not fully appreciate the need to be accountable for their process controls. District Offices have provided plants with guidance on what is necessary to avoid a continued suspension of inspection. Further failure to address the causes of the noncompliance can result in the issuance of a Notice of Suspension covering all or parts of a plant’s operations. If the plant will not or cannot come into compliance, inspection might be withdrawn.
Another concept concerns the growing importance of truthful and accurate record keeping by meat and poultry plants. Plants need records to verify that their control measures have worked and that their products are safe and wholesome. Inspectors rely upon both "hands on" observations and reviews of plant records to assess whether systems are functioning properly to produce safe products. Plants that maintain false or deceptive records to avoid inspection oversight are in jeopardy of criminal prosecution, and priority will be given to these cases.
These enforcement actions 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 allowing 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.
On January 12, 1998, FSIS published its Proposed Rules of Practice in the Federal Register as part of FSIS’s ongoing efforts to consolidate, streamline, and clarify the meat and poultry product inspection regulations. These proposed rules are intended to supplement existing rules of practice. They will more clearly spell out the responsibilities of a plant regarding refusal, suspension, or withdrawal of inspection services when the Agency determines that a plant’s HACCP or SSOP systems are inadequate or ineffective, or a plant is not meeting the Salmonella pathogen reduction performance standards, or is not complying with generic E. coli testing requirements.
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