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Systematic planning enhances the effectiveness of retail food regulatory programs.

A post-inspection compliance program is the system used by retail food regulatory agencies to deal with non-complying retail food operators who do not or will not correct code violations voluntarily. In most jurisdictions, this program is used against a relatively small portion (approximately 10-20 percent) of retail food operators. The system is typically used only when on-site resolution has failed and the operator refuses or fails to comply voluntarily with the recommendations, warnings and orders of the regulatory agency.

Despite the fact a post-inspection compliance program is used sparingly, it is important for a retail food regulatory agency to have a system in place that will deal effectively with non-complying operators. In fact, the overall effectiveness of a retail food protection program often hinges on the regulatory agency's ability to secure compliance with code requirements when violations are not "voluntarily" corrected through on-site resolution.

When a program planner is designing a post-inspection compliance program, he or she must consider all aspects of the retail food regulatory system. Special consideration should be given to the overall regulatory scheme for insuring food protection, the goals and objectives of the retail food regulatory program, and the interrelationships that exist among specific retail food law regulatory activities. The planner must understand the regulatory context in which a post-inspection compliance program operates and the possibilities and limitations provided by the overall regulatory scheme, including existing laws and regulations. In order to appreciate the "trees" (i.e., alternative compliance strategies), the planner first must see the "forest" or, in this case, the retail food regulatory system as a whole.

To aid the planner in formulating an effective compliance program, a "systems approach" to the planning, implementation and evaluation of the program is recommended. The systems approach allows the planner to consider the significant factors that influence program design and the ultimate success of a compliance program. Systems planning also aids the development of a compliance program that will function effectively within the context of the larger regulatory system.

The traditional systems approach for analyzing governmental operations and services, including regulatory systems, involves five interrelated factors that influence the nature, quantity and quality of the products of the system.

* environment

* input

* process

* output

* feedback

Environment

The environment consists of those external considerations, conditions and factors that facilitate, inhibit, or otherwise influence the organization and operation of the system. Regulatory systems and compliance programs are not developed in a vacuum and seldom represent the "best" or "ideal" approach to achieving public goals and providing services to reach those goals. Real-world governmental systems are the result of policy choices shaped by the interplay of a variety of entities and interests, including legislative bodies, regulated parties, the general public, and regulatory agency policy makers.

The environment defines what a planner can and cannot do and to a large degree what should be done. The range of choices available to the planner of a governmental program is limited by the policy decisions and compromises that have been made by others. The first step in the planning process is to identify and assess the impact of the environmental factors that affect the planner's range of choices in designing a program.

The environment includes laws and regulations. The law is embodied in statutes or ordinances, administrative rules or regulations, and court decisions and is clarified by opinions of the state attorney general and the regulatory agency counsel. The law sets the boundaries of regulatory agency action. Depending on the applicable law, the regulatory agency may or may not have discretion to fashion appropriate programs. If the law is too restrictive, the regulatory agency may need to seek new or amendatory legislation authorizing a program it desires to initiate.

The costs of a program, not only to the regulatory agency but also to the regulated industry and the general public, must be considered. Community demographics, or the characteristics of the jurisdiction and its citizens, frequently influence program design and operation. The number and distribution of residents in the jurisdiction served by a regulatory agency, the geographic area covered by a regulatory agency, the prevailing socioeconomic conditions of the area, and the type of governmental system within which the regulatory agency operates are examples of demographic variables that may affect program design. The local tradition and history of employing or not employing regulatory schemes to achieve social goals provide an indication as to whether, and what kinds of, new regulatory programs will be accepted by the general public, regulated industries, and governmental policy makers, including the regulatory agency itself.

The organization and structure of the governmental system within which the regulatory agency functions has a crucial impact on the kinds of programs that can be initiated. The internal organization and decision making procedures of the regulatory agency can either facilitate or inhibit innovative approaches and programs. Program choices are also influenced if external agencies must be involved, either in the approval of a new program or in its implementation.

Two additional environmental factors must be assessed. The nature of the regulated industry, including the number, type and location of regulated facilities and operations and the problems and risks presented by the industry, is a fundamental planning consideration. And finally, the need for regulatory action or non-action must be determined. The perceived need for regulatory action reflects the attitudes, preferences and influence of the general public, key public officials, and even the regulated industry concerning the necessity, type and scope of regulatory action. The demand for positive regulatory action can provide the impetus for new programs and support for their funding and implementation.

Input

The input for a regulatory system, which is acted on or processed and convened into output, includes the regulatory targets -- the specific facilities and operations of the regulated industry that are to be subject to action by the regulatory agency. In the public health context, the input could be facilities that pose a substantial risk to the health and well-being of the general public by their non-compliance. Goals and objectives for a program must be defined. The expectations for a program must be established in order to determine whether the program is successful, i.e., producing the intended outputs. A public health program will have goals and objectives to control, reduce, or eliminate the risks presented by the regulatory targets.

The resources required, such as staffing and funding, are an obvious consideration in program design. A program planner must prepare a realistic budget or financial plan as to the resource requirements for a program. Once resource demands are determined, the planner must ascertain whether the resources are available and whether they can be assigned to support the program. If the resources are not currently available, the planner must identify what additional resources are required and determine how to obtain the needed resources, perhaps through increased appropriations or fees or charges assessed against the regulated industry.

Related to resource requirements are the capabilities and competencies of the personnel who are to have a key role in a proposed program. The program must be within the capacity of the assigned personnel to implement. If the program requires skills and capabilities not possessed by the key participants, the planner must consider skill development through a training program, the employment of new personnel with the requisite competencies, or modification of the program to eliminate the requirement for the unattainable competencies.

Process

The process element, which is the heart of a system, converts system input into output. It is what most observers would consider to be the "program," the visible activities undertaken by the regulatory agency. The process consists of the methods and procedures for implementing a program and the key participants involved in carrying out the methods and procedures. The program planner must consider what is to be done and who is going to do it. A program plan must be prepared detailing the regulatory strategies to be employed, the specific tasks and activities for carrying out the strategies, the agencies and individuals responsible for implementing each task, and the timetable for completing each task. In addition, the information needed for completion of each task must be identified and provided, and areas for interagency coordination determined and appropriate cooperative arrangements made.

Output

The system output is the results or products of the processing of input. The output or performance of a regulatory system could be regulations, services or benefits to the public. In public health, the output of a regulatory system might be regulations designed to control the risk of illness or disease, risk-reduction services such as the inspection of food and drags, and improvements in the level of public health resulting from individual actions to eliminate certain health risks (e.g., proper handwashing to reduce microbial contaminants that can be transferred to food and food contact surfaces).

The output of a regulatory system can be measured in a number of ways:

* Public health impact -- The reduction of health risks or the increase in healthy or risk-controlled environments, conditions and operations due to actions and interventions of the system (e.g., reduction by 10 percent of disease and illness resulting from contaminated or adulterated meat and poultry products in a calendar year).

* Positive outcomes -- The extent to which the system or specific system actions achieve intended positive or successful outcomes (e.g., 99 percent of retail food service operators corrected all four and five demerit point items within 48 hours after an inspection).

* Achievement of goals and objectives -- The degree to which the system attains the specific objectives set for system performance (e.g., a program made 98.4 percent of the planned number of food service inspections during a calendar year).

* Activity or performance levels -- The number of actions taken by the system (e.g., a program conducted 412 food service inspections during a calendar year).

* Productivity -- The efficiency of the system in producing output, usually expressed by a rate calculated by dividing output (such as activities or successful outcomes) by input (such as level of effort or cost) (e.g., 3.2 food service inspections were conducted per inspector per day, or the cost of inspections was $157.00 per inspection).

Feedback

The output of a regulatory system serves as "feedback" to the environment and influences subsequent policy choices concerning the structure, management and operation of the system. The degree of success of a regulatory system affects future demand for regulatory action; a program that fails to achieve any appreciable improvement in public health or the performance objectives set for the program very likely will not receive support for continued funding and operation. If the cost of a program is considered excessive in relation to the benefits realized, the program may be modified or even abandoned.

Choosing the most suitable specific compliance strategies

The specific compliance strategies (e.g., informal conferences, administrative hearings, citations and court proceedings) that may be used in a jurisdiction are often dependent on a number of factors that do not relate to the effectiveness or efficiency of the strategy. For example, the tradition or history of using or not using court actions to achieve public health objectives may facilitate or inhibit the adoption of new court-related strategies. A regulatory system that previously has used court action or inspector-issued citations against environmental law or housing code violators may be more inclined to employ court action against retail food law violators.

The "systems approach" described earlier can also be used in analyzing each element of a typical system -- environment, input, process, output and feedback. A flow chart depicting these "system" elements for any formal compliance strategy is presented in Figure 2. A planner should attempt to answer the following questions when designing a new or modifying an existing post-inspection compliance program and evaluating alternative compliance strategies for inclusion in the program.

Compliance strategy environment

The environment for a compliance strategy consists of:

* Laws and regulations -- What are the applicable statutes, ordinances and regulations pertaining to the regulation of retail food facilities and operations? Are there any court decisions or opinions of the attorney general or regulatory agency legal counsel that have construed the law? What do the laws and regulations require? What discretionary action do they permit?

* Nature of the regulated industry -- How many retail food facilities operate in the jurisdiction ? Types of food operations? Location of the facilities? What public health risks and problems are presented by retail food operations?

* Costs of regulation -- How much will it cost to carry out the strategy? Is the cost reasonable for the probable benefits to be realized? Will funding for the strategy be approved?

* Community demographics -- What are the key demographic characteristics that will affect the use of the strategy ? Population size? Geographic area? Socioeconomic conditions? The local governmental system: Who adopts retail food law requirements? Who funds the regulatory agency? Who has approval authority over the compliance program?

* Tradition and history -- What other regulatory schemes have been adopted in the community? Has a specific compliance strategy been employed before? Was it successful? Was it accepted by the general public, key governmental officials (such as the local legislative body), and the regulated industry?

* Organization and structure -- Who must be consulted within the regulatory agency? Who within the agency must approve the compliance program? Who must be consulted outside the agency? Who outside the agency must approve the program? What agencies and individuals are to be key participants in the compliance program? Will key participants work cooperatively and effectively together?

* Demand for compliance actions -- What do the general public, key government officials, the regulatory agency, and the retail food industry want the regulatory agency to do to obtain compliance with retail food laws? What kinds of compliance strategies will they accept? If acceptance is a problem, can they be convinced to support the compliance strategy?

Compliance strategy input

The input considerations for a compliance strategy are:

* Non-complying retail food facilities and operations -- How many and what types of regulated retail food facilities are found to be in violation of the existing retail food laws? Which violations are not being corrected as ordered by the regulatory agency? Which violations are not being corrected or reoccur even after one or more compliance actions have been taken? Why are violations not being corrected?

* Goals and objectives -- Have the overall goals and specific objectives of the regulatory agency's compliance program been specified? What are they? Are they being achieved? If not, why not?

* Resources -- What resources, such as personnel, are available currently for the compliance program? What additional resources will be required? Will additional resources be approved?

* Capabilities and competencies -- What are the skills and capabilities required for key personnel in the compliance program? Do the key personnel have the requisite skills and capabilities to perform their duties effectively? If not, can the situation be remedied by training, new personnel, or program redesign?

Compliance strategy process

The process function for a compliance strategy includes:

* Methods and procedures -- What specific strategy or combination of strategies will achieve the compliance program's goals and objectives after consideration of the environment and input constraints? What is the most effective and efficient manner of implementing an acceptable strategy? What are the information support needs for the program? What intra-agency and inter-agency cooperation and coordination is required?

* Key participants -- Who are the key participants in the compliance program? What will the duties be for each key participant? Will they accept their role in the program and perform their duties effectively?

Compliance strategy output

The intended products of every compliance strategy are 1) prompt compliance by non-complying retail food operators with the legal and regulatory agency requirements to ensure that an acceptable level of sanitation is achieved, and 2) the application of appropriate penalties against non-complying retail food operators to ensure that there is no repetition of non-compliance and that other retail food operators will be deterred from acts of non-compliance in the future.

The output of the application of a compliance strategy also contributes to the overall goals of the regulatory system and the post-inspection compliance sub-system: 1) reduce and maintain at an acceptable level the risk and incidence of foodborne-illness outbreaks; and 2) increase and maintain at an acceptable level the sanitation conditions of regulated retail food facilities and operations.

The output for a compliance strategy may include one or more of the following types of output:

* Public health impact -- What specific public health benefits are anticipated as a result of the compliance program and the specific compliance strategies to be employed: Reduction of risk of foodborne illness? General deterrence of code violations by the retail food industry? Specific deterrence of code violations by non-complying retail food operators who have been subjected to compliance actions by the program?

* Positive outcomes -- What specific improvements or beneficial outcomes are intended (e.g., 90 percent of initiated compliance actions produce a successful result, such as "compliance," "conviction," "closure," "suspension/revocation," or "voluntary destruction")?

* Achievement of goals and objectives -- What degree of accomplishment of program goals and objectives is intended (e.g., realize a 95 percent or higher level of achievement of compliance program objectives)?

* Performance levels -- What specific compliance program and strategy activities will be conducted (e.g., 250 reinspections or 30 administrative hearings)?

* Productivity -- How efficiently are the compliance program and strategies expected to be operated (e.g., $500.00 per administrative hearing or six personnel-hours per court case)?

Compliance strategy feedback

The output of each compliance approach also constitutes "feedback" to the environment; that is, the success or failure of the strategy in terms of inducing compliance or in applying appropriate penalties, as well as other factors such as cost, time, and perceived severity of penalties, influence whether the strategy will be continued, when and for whom it will be used, and what resources will be allocated in the program. Managers and planners must review the performance of a compliance program periodically and adjust or replace the strategy if it is not producing the intended output.

Conclusion

A post-inspection compliance program is a vital component of the overall retail food regulatory system. If properly executed, it provides the means to control the behavior of retail food code violators and induce them to comply with applicable retail food codes.

There are a number of compliance strategies available for consideration by the planner of a post-inspection program for responding to non-complying conditions at retail food facilities. However, the needs and requirements for successful implementation of the different strategies vary greatly.

The retail food regulatory program planner must be able to design a compliance program that will achieve program goals and objectives in an effective, efficient and acceptable manner. This requires careful analysis of the many internal and external factors that influence the ultimate success of the compliance program. The use of the systems approach will enable the planner to consider the significant factors that influence program design and the ultimate success of a compliance program, and to develop a compliance program that will function effectively within the context of a larger regulatory program.

David Z. McSwane, H.S.D., Indiana University School of Public and Environmental Affairs, Business/SPEA Bldg. 3025, 801 W. Michigan St., Indianapolis, IN 46202.
COPYRIGHT 1993 National Environmental Health Association
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Copyright 1993, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

Article Details
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Author:Mitter, Eric L.
Publication:Journal of Environmental Health
Date:Jul 1, 1993
Words:3182
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