Need for a State Internal Auditing Tool - Using Standards Established by the National Shellfish Sanitation Program
Julie Henderson
Virginia Department of Health, Division of Shellfish Sanitation
International Food Protection Training Institute
2010 Fellow in Applied Science, Law and Policy: Fellowship in Food Protection
Abstract
This project involved an assessment of the existing National Shellfish Sanitation Program (NSSP) implementation practices to determine a potential need for an auditing tool for states to internally assess their program’s compliance with the NSSP guidelines. To determine this need, a qualitative content analysis was conducted to examine whether the Manufactured Food Regulatory Program Standards could be an appropriate model used to identify gaps and ensure equivalency. The documents examined in this qualitative review included the NSSP Model Ordinance, the 2010 Manufactured Food Regulatory Program Standards, and a federal report issued by the U.S. Office of the Inspector General regarding greater accountability of the U. S. Food and Drug Administration (FDA) oversight of state food inspections. The results of this study indicate that state shellfish authorities vary significantly in their ability to comply with the NSSP and the implementation of the Model Ordinance.
Background
The Virginia Division of Shellfish Sanitation (DSS) participates in the NSSP, which is a federal, state, and shellfish industry cooperative program. The partial purpose of this program is to develop shellfish standards as a Model Ordinance and to ensure cooperation and uniformity of state shellfish programs. Within the NSSP, state shellfish authorities have the primary role of implementing and enforcing these standards. The FDA provides oversight and technical guidance to the states. One of the responsibilities of the FDA is to conduct biennial evaluations of state shellfish authorities in order to ensure compliance with the NSSP.
In order for shellfish industries to engage in interstate commerce, the state in which the industry resides must participate in and be a member of the Interstate Shellfish Sanitation Conference, or the ISSC (Interstate Shellfish Sanitation Conference, 2007). The state shellfish authorities and the shellfish industries must conform to the NSSP administered by the FDA through a Memorandum of Understanding (MOU) with the ISSC (U.S. Food and Drug Administration, 2011). The ISSC is comprised of representatives from the shellfish industry; state shellfish authorities; the FDA Shellfish, Seafood, and Aquaculture Branch; and various federal experts from the Centers for Disease Control and Prevention (CDC), the National Oceanic and Atmospheric Administration (NOAA), and the Environmental Protection Agency (EPA). The ISSC gives the primary responsibility for the sanitary control of shellfish to the states (Interstate Shellfish Sanitation Conference, 2007). The standards set forth in the NSSP ensure that the harvest, processing, and shipping of shellfish is conducted in a manner that maintains the safety and quality of shellfish. The state shellfish authorities conduct inspections of shellfish processors and handlers, and issue certificates to those processors and handlers that meet adopted standards.
As required in the ISSC and FDA MOU, the FDA conducts biennial evaluations of state shellfish authorities, which include assessments of the states’ shellfish processor/shipper inspection programs to assess whether the states are ensuring industry compliance with the NSSP (U.S. Food and Drug Administration, 2011).
The FDA instituted the Manufactured Food Regulatory Program Standards (MFRPS) in 2008 in order to establish a uniform foundation for the design and management of state programs responsible for the regulation of food plants (U.S. Department of Health and Human Services, 2010). The elements of the standards describe the best practices of an exemplary regulatory program. The FDA’s institution of standards are intended to assist states in identifying problem areas in most need of additional attention, to provide information needed to justify maintenance or an increase in program budgets, and to lead to innovations in program implementation and administration (Center for Food Safety and Applied Nutrition, 2011). The MFRPS recommends that states conduct internal audits of their regulatory food programs and submit improvement plans to the FDA. The improvement plans are intended to assist the FDA in conducting state audits and in improving regulatory programs (Brown, 2000).
Problem Statement
A principal goal of state shellfish authorities is to prevent foodborne disease and conduct plant inspections to enhance shellfish safety by ensuring that all facilities adhere to a set of uniform standards for processing and handling practices. An inspection system is most effective when the standards are uniform, consistently applied, and focused on identifying characteristics known to affect shellfish safety. The FDA conducts biennial evaluations of state shellfish authorities, which include assessments of the states’ shellfish industry inspection programs. FDA State Shellfish Specialists conduct the evaluations using a risk-based approach to determine compliance status (FDA Shellfish Compliance Program FY2011). The evaluation report provided to the state shellfish authority is intended to provide general information and to focus on the accuracy of state inspection findings. These evaluations, however, are not intended to focus on identifying gaps in the state plant program or on implementing best practices (Paul Distefano, Office of Food Safety, Division of Food Safety, FDA, personal communication, January, 2011). To address these concerns, this study investigated (1) the existing internal auditing tools necessary to ensure compliance with the NSSP’s Model Ordinance and (2) whether the FDA Manufactured Food Regulatory Program Standards (MFRPS) is an appropriate model for a state shellfish authority auditing tool.
Methodology
A qualitative content analysis was performed to address specific research questions that examined the efficacy of an assessment and whether the Manufactured Food Regulatory Program Standards should be considered an appropriate model used to identify gaps and to ensure equivalency. The documents examined in this review included the NSSP Model Ordinance, the 2010 Manufactured Food Regulatory Program Standards, and a federal report issued by the U.S. Office of the Inspector General regarding greater accountability of the FDA oversight of state food inspections.
Results
The content analysis has indicated that the Office of Evaluation and Inspections (OEI) within the Office of the Inspector General in their June 2000 report, FDA Oversight of State Food Firm Inspections, assessed the FDA’s oversight of food firm inspections conducted by states (FDA Oversight of State Food Firm Inspections: A Call for Greater Accountability). This report concluded the following: states vary significantly in their capacities to conduct inspections due to enforcement authorities, inspection authorities and regulations, inspector education and training, and time spent on inspections; the FDA evaluations focus on the accuracy of inspection findings but give little attention to how state inspectors draw conclusions; and the FDA rarely seeks input from external sources, such as public meetings, to evaluate a state’s performance. The report also recommended that the FDA provide proactive disclosure of state evaluations and provide information from varied external sources on state inspection performance.
State shellfish authorities vary significantly in their ability to comply with the NSSP and their implementation of the Model Ordinance. States’ current abilities to comply with the Regulatory Foundation, Standard 1—which would require the authorities to have the legal authority and regulatory provisions to perform inspections and gather evidence, collect samples, and take enforcement actions under state laws—are limited. Out of thirty-five states that are members of the ISSC, only three states have the current Model Ordinance as regulation. Five states have an older version of the Model Ordinance as regulation, and the other twenty-seven states have implemented limited regulations that require certification and the use of the Model Ordinance as a guide.
The goals of facility inspections are to ensure sanitary processing environments that protect public health, to ensure compliance with federal guidelines (Good Food Manufacturing Practices and HACCP), and to provide technical advice on routine problems, as well as to coordinate with universities and state and federal agencies to help industry solve emerging issues. State shellfish authorities vary, however, in their capacities to conduct inspections due to the varying agencies in which the programs are administered. The state inspection programs are currently administered through departments of public health, agriculture and consumer services, environmental conservation, natural resources, and marine resources. Of the thirty-five states that are members of the ISSC, twenty states are under the framework of public health agencies, nine states operate under departments of agriculture, and the remaining six other states are within departments of natural or marine resources.
Newly-hired State Shellfish Specialists are required by the NSSP Model Ordinance to attend shellfish courses and to undergo an initial standardization prior to performing independent inspections (Interstate Shellfish Sanitation Conference, 2007). The State Shellfish Specialist standardizations expire every five years and require inspections with a State Standardization Officer. The Training Program, Standard 2 points out that there is no formal mechanism for periodic training after standardization, nor a means of determining how periodic training might affect the inspection program.
The FDA’s state shellfish authority evaluations determine trends and common deficiencies found during inspections and are not designed to identify specific weaknesses and gaps in the state shellfish authority’s implementation of the Model Ordinance, as identified in Standard 3, Inspection Program. FDA State Shellfish Specialists have a variety of expertise concerning the shellfish program that may not be specific to the plant program. FDA Specialists evaluate the state shellfish authorities for growing area, harvest enforcement, and the plants. Therefore, depending on the specialist, the state inspector may have more expertise than the evaluator on the specific program being evaluated (Paul Distefano, Office of Food Safety, Division of Food Safety, FDA, personal communication, January, 2011).
The Virginia Division of Shellfish Sanitation (DSS), for example, conducts an annual measurement by evaluating a developed work plan that includes individual performance reviews. The work plan projects the staff-hours expended in the program and the staff hours are compared to the previous year’s data (Dr. Robert Croonenberghs, Director, Virginia Department of Shellfish Sanitation, personal communication, December, 2010). This analysis is quantitative and does not assess the effectiveness of Virginia’s programs in protecting public health or Virginia’s ability to comply with the NSSP Model Ordinance.
The state evaluations are not communicated to the ISSC. The NSSP Evaluation Criteria Committee, which has been assigned the task of reviewing the FDA Shellfish Sanitation Plant Element Evaluation Criteria, reported an example of this lack of transparency. The committee has not been presented with a specific list of criteria that the state programs could not meet. The committee concluded during the 2009 ISSC Biennial Conference that the committee members were not clear whether the compliance criteria were too stringent or whether the state programs must be more diligent in applying the NSSP Model Ordinance criteria (Hickey, 2009). The FDA was to provide an interim report to the committee at the end of 2009 on the status of the pilot NSSP plant evaluation criteria; this report has not yet been submitted, however.
Conclusions
A state shellfish authority’s internal audit could be used to conduct an evaluation of a program’s ability to comply with the NSSP Model Ordinance. In addition, the FDA state shellfish authority evaluations, if reported to the ISSC, could help to discern if the Model Ordinance contains gaps that cause shellfish industry compliance issues and state shellfish authority implementation problems.
This ongoing study will hopefully result in the implementation of a National Shellfish Plant Program Standards Manual that could improve the ability of the Virginia Division of Shellfish Sanitation and other state shellfish authorities to ensure the safety of shellfish and subsequently reduce foodborne illnesses from shellfish consumption. Additionally, a draft National Shellfish Plant Program Standards Manual based on the MFRPS was developed for future use that could be used to assess the state shellfish authorities’ abilities to comply with the Model Ordinance.
Ideally, an internal audit conducted by a state shellfish authority would determine the cause of repeated common deficiencies and whether the deficiencies were possibly due to inadequate training for inspectors, inadequate implementation of regulations, or poor communication with the shellfish industry. The results of a self-assessment using standards provide a procedure for establishing a database that may be used to track the results of regulatory and industry efforts over time (Center for Food Safety and Applied Nutrition, 2011).
Though an assessment can be made of a state shellfish authority based on the number of foodborne illnesses, the assessment is not an accurate one, due to states having established that many shellfish-related illnesses go unreported. Diseases that are considered nationally notifiable may or may not be designated by a given state as reportable in the state. Disease reporting is currently mandated by legislation or regulation only at the state and local level (Centers for Disease Control and Prevention).Lack of outbreaks or single illnesses cannot be used to determine Standard 5 compliance alone. The CDC estimates that approximately 2,800 Vibrio parahaemolyticus illnesses each year are due to raw oyster consumption (Center for Food Safety and Applied Nutrition, 2005). The number of reported Vibrio illnesses attributed to a state shellfish authority determines current Model Ordinance post-harvest handling requirements (Interstate Shellfish Sanitation Conference, 2007). State-by-state comparison is difficult since states establish their own rules and procedures. Some states only report confirmed cases to CDC. States determine when and how to investigate illnesses and whether to use an active or passive system (Centers for Disease Control and Prevention).
Due to the varying types of agencies that implement state shellfish programs, there are significant differences in the ways in which inspections are conducted, enforcement is implemented, training is fulfilled, outbreaks addressed, recalls conducted, and regulations promulgated. Standard 6 (Compliance and Enforcement Program) would help to ensure uniformity and equivalency among states.
Inclusion of the ISSC in reviewing the FDA evaluations, following Standard 7, Industry and Community Relations, would help to solicit feedback from industry, consumer, and other groups on the adequacy of state inspections (FDA Oversight of State Food Firm Inspections: A Call for Greater Accountability). Use of a National Shellfish Plant Program Standards Manual as an internal auditing tool is necessary as determined in Standard 9, Program Assessment. Development of a strategic improvement plan can only help a state shellfish authority’s ability to protect the health of consumers.
Recommendations
As a result of conducting this study, the following recommendations can be offered for consideration:
1. Submittal of a proposal at the 2011 Interstate Shellfish Sanitation Conference to develop a pilot audit to be used in the FDA state shellfish authorities’ plant program evaluations.
2. Development of a National Shellfish Plant Program Standards Manual, designed as an auditing tool for state shellfish authorities to use in the assessment of their inspection programs.
3. The Manual’s use, as a guide, of the Manufactured Food Regulatory Program Standards established by the U.S. Food and Drug Administration.
4. The Manual’s incorporation of the requirements set forth in the National Shellfish Sanitation Program Model Ordinance.
5. Public disclosure of the FDA state shellfish authority evaluations to be used as a comprehensive evaluation of states’ performances by the ISSC.
Acknowledgments
This project was initiated through participation in the International Food Protection Training Institute’s (IFPTI’s) 2010 Fellowship in Food Protection program. My IFPTI mentor, Dan Sowards, and co-Fellow, Lucus Pols, provided needed advice and invaluable suggestions throughout this project. The Office of Environmental Health Services and the Division of Shellfish Sanitation (specifically, Robert Hicks, OEHS Director, and Dr. Robert Croonenberghs, DSS Director) gave the support for the Fellowship program participation and the encouragement necessary to conduct this project. The Association of Food and Drug Officials (AFDO) deserves a thank you for AFDO’s promotion of IFPTI and for the organization’s sponsoring the IFPTI Fellows’ participation in the 2011 AFDO Annual Educational Conference. I also wish to thank Keith Skiles, Virginia DSS Growing Area Classification Chief, for his tireless editing efforts.
Corresponding Author:
Julie Henderson, Virginia Department of Health, Division of Shellfish Sanitation. Email: julie.henderson@vdh.virginia.gov
References
Brown, J. G. (2000). FDA oversight of state food firm inspections . Office of Inspector General, Department of Health and Human Services.
Center for Food Safety and Applied Nutrition. (2005). Quantitative risk assessment on the public health impact of pathogenic vibrio parahaemolyticus in raw oysters . U. S. Department of Heath and Human Services, Food and Drug Administration.
Center for Food Safety and Applied Nutrition. (2011). Voluntary national retail food regulatory program standards. U. S. Department of Health and Human Services, Food and Drug Administration.
Centers for Disease Control and Prevention. (n.d.). What data users should know about the National Notifiable Diseases Surveillance System. CDC.
FDA Oversight of state food firm inspections: A call for greater accountability. U.S. Food and Drug Administration, Office of Inspector General.
Hickey, M. (2009). NSSP Evaluation Criteria Committee Report . Interstate Shellfish Sanitation Conference Biennial Meeting.
Interstate Shellfish Sanitation Conference. (2007). Retrieved from http://www.issc.org/NSSP/Default.aspx
U.S. Department of Health and Human Services. (2010). Manufactured food regulatory program standards. Food and Drug Administration , Office of Regulatory Affairs .
U.S. Food and Drug Administration. (2011). Food and Drug Administration compliance program guidance manual. The Molluscan Shellfish Compliance Program.