Managing food safety in retail food establishments through the implementation of active managerial controls Janet Stetzer, CLS, RS

Montana Department of Public Health and Human Services, Helena, Montana

Problem Statement

Restaurant-acquired foodborne illness is a major public health concern in the United States. The Centers for Disease Control and Prevention (CDC) estimates the number of annual cases of foodborne illness to be 76 million, resulting in more than 300,000 hospitalizations and 5,000 deaths. Periodic inspection of retail food establishments has not succeeded in achieving a measurable decrease in foodborne illness or its observed risk factors. Figure 1 illustrates the national percentages of five identified causes of foodborne outbreaks from 1988 to 1992. Figure 2 illustrates the percentage of observations of these risk factors found to be out of control during a study of retail food establishments by the US Food and Drug Administration (FDA). Holding temperatures, the most common contributors to foodborne illness, were found to be out of control in over 60% of observations, confirming that current inspection methods are not successfully eliminating the causes of foodborne illness.

Figure 1

Causes of Outbreaks 1988-1992

40 35 30 25 20 15 10 5 0 Improper Holding Temperature Poor Employee Hygiene Inadequate Cooking Contamination

Risk Factor Violation

Unsafe Sources Figure 2

Occurence of Risk Factor Violations

70 60 50 40 30 20 10 0 Hot and Cold Holding Time & Temperatures Employee Hygiene Cooking Temperatures Contamination Prevention Food From Approved Sources

Risk Factor

Behavior Over Time

Observed Risk factor Violations Ability of operators to self-regulate Cooperation between inspectors and operators Reliance on periodic routine inspections TIME

Causal Loop Diagrams and Applicable Archetypes

The primary archetype identified in the Montana Food Safety program is “Shifting the Burden”. The program relies on the “quick fix” of periodic inspection and correction to eliminate the precursors to foodborne illness. The ability of periodic inspection programs alone to achieve food safety remains inconclusive. As emphasis continues to be placed on the policeman role of inspectors, less education is provided to operators and less opportunity exists for them to develop their abilities to self-regulate. Educating operators on food safety and assisting them in developing systems of controls within their establishments has been shown by a retrospective cohort study of the Minneapolis Announced Inspection Program and by an Environmental Health Specialists (EHS-Net) study to achieve sustainable improvement in food safety, as evidenced by a reduction in precursors to foodborne illness. This approach is consistent with the growing trend for preventative action in the form of Active Managerial Control in restaurants to identify and control potential hazards specific to the operation of their establishment.

Training of operators will require a commitment by inspectors and will initially be time consuming. However, as operators begin to self regulate and monitor their own processes, the time burden on inspectors will be decreased.

* A second archetype, a “Fix that Fails”, reinforces the reliance on inspections at the expense of education. Establishments are licensed by the state and the license fees, which are collected by the state, are disbursed to local health departments based on inspection performance. Funds are disbursed per completed inspection. This system has not produced a measurable increase in the number of inspections completed, nor in a reduction in the occurrence of precursors to foodborne illness. Because inspectors are paid per inspection, a logical strategy is to complete as many of the easiest inspections as possible before initiating the more time-consuming inspections. The result is less attention paid to the highest-risk establishments and is exactly opposite of the desired outcome. The inevitable side affect of this system is a subordinate status for local sanitarians and subsequent deteriorating relationships between state and local staff.

SHIFTING THE BURDEN FIXES THAT FAIL

I have to find all these violations and get them corrected before I leave.

Improvements are sustained Inspectors and operators work as a team

This is my business. Finally I am in control!

I’m not going to do his job for him. He’s the inspector. Let him fix it.

Reliance on inspection to assure safety and eliminate precursors to foodborne illness.

B

Risk factors for foodborne illness

B

Control of risk factors by operators (

Active Managerial Control) Regulators and operators view inspectors as ‘police’. Operators turn over control to inspectors. Inspectors do not attempt to educate operators .

R

Improvements are temporary. Need for Inspectors and multiple operators inspections. work as Less time adversaries.

available for education.

These operators have to start taking more responsibility I can’t be here everyday. They make the same mistakes.

If they do enough inspections, they will eliminate the precursors

Occurrence of precursors to foodborne illness.

B

Reliance on inspection to assure safety and eliminate precursors to foodborne illness. License fee distribution based on number of inspections performed.

R

Pressure to reach inspection quotas. High-risk establishments are neglected. Education is minimal .

I don’t have time to educate operators today!

I’ll do all of the quick easy inspections first - that way I get more money.

Results

This project seeks to achieve more than simple process modifications. It seeks to change Montana’s food safety culture: the way we look at ourselves and at our peers and partners. The success of this project demands that both inspectors and operators abandon their traditional roles and embrace the FDA concept of Active Managerial Control that states, “Ultimate responsibility for the development and maintenance of effective food safety systems lies with the management of institutional foodservice, restaurant and retail food store operations.” State and local health departments must embrace the opportunity to empower operators and to provide them with education and technical assistance. As the obvious FDA “Gold Standard” for the management of food safety, it is appropriate and rational for the State of Montana to adopt these principles as their preferred approach to food safety. Several important prerequisites to the implementation of Active Managerial Control are already in place. Next steps will include the marketing of the program to health departments and industry, the training of inspectors and operators, and the evaluation of results achieved by the pilot programs. This program will proceed incrementally, as the thousands of retail food establishments in Montana are approached in order of their assigned risk rating. It can be expected that not every operator will be willing or able to fully implement Active Managerial Controls, although the approach will be welcomed by most. When the program is fully implemented, we anticipate: • a decrease in the number of risk factor violations, • improved cooperation between operators and regulators, • improved relationships between the state program and local health departments, • a more competent workforce, • a more efficient and cost-effective environmental health delivery system, • improved public health

ESSENTIAL SERVICES ADDRESSED

Evaluate Develop policies

Inform, educate, empower Access Assure competent workforce

Mobilize community partnerships

Literature

The Fifth Discipline,

Senge P, Kleiner A, Roberts C, Ross RB, Smith BJ. Currency Doubleday; 1994.

U.S. Food and Drug Administration  Management of Food Safety Practices, 2005 Food Code  Measuring the Effectiveness of the Nation’s Food Service and Retail Food Protection System  Draft Voluntary National Retail Food Regulatory Program Standards  FDA Report on the Occurrence of Foodborne Illness Risk Factors (2004)  Report of the FDA Retail Food Program Database of Foodborne Illness Risk Factors  Managing Food Safety:, 2006  Prevention is Key to Avoiding Foodborne Illness Outbreaks National Environmental Health Association  Beneficial effects of implementing an announced restaurant inspection program, 2007 U.S. Centers for Disease Control and Prevention  CDC Health Protection Goals  A National Strategy to revitalize Environmental Public Health Services  Environmental Health Competency Project U.S. Department of Health and Human Services  Healthy People 2010  Public Health in America

Mary Simmons, MA

Supervisor Environmental Health Montana Public Health

Anne Weber, MS

Chief, Laboratory Services Montana Public Health

Bradley E. Tufto

FDA Retail Food Specialist, Pacific Region Spokane Resident Post

Acknowledgements

LCDR Gary W. Carter, MPH, RS, CIH Mentor

Environmental Health Officer Billings Area Indian Health Service

Christine Cox, RS/REHS

Retail Food Program Manager Montana Public Health

Jerry Cormier, RS/CPO

Eastern Montana Field Office Montana Public Health

Jennifer L. Pinnow, RS/REHS

Assistant Director Environmental Health Yellowstone City-County Health