Corrections after FDA and Wisconsin Manufactured Food Inspections Show Comparable Compliance Rates
Skya Murphy
Program and Policy Analyst
Wisconsin Department of Agriculture, Trade and Consumer Protection
International Food Protection Training Institute (IFPTI)
2017 Fellow in Applied Science, Law, and Policy: Fellowship in Food Protection
Author Note
Skya Murphy, Program and Policy Analyst-Adv, Wisconsin Department of Agriculture, Trade & Consumer Protection.
This research was conducted as part of the International Food Protection Training Institute’s Fellowship in Food Protection, Cohort VI.
Correspondence concerning this article should be addressed to Skya Murphy,
Wisconsin Department of Agriculture, Trade & Consumer Protection, 2811 Agriculture Dr., P.O. Box 8911, Madison, WI 53708-8911, Email: Skya.Murphy@wisconsin.gov
Abstract
Comparable regulatory inspections are a critical component of establishing an Integrated Food Safety System (IFSS) in the state of Wisconsin. Compliance effects of inspections performed by U.S. Food and Drug Administration (FDA) and Wisconsin Department of Agriculture, Trade and Consumer Protection (WDATCP) at manufactured food plants in Wisconsin were compared by analyzing rates of correction of violations between inspections. Inspectional outcomes documented in FDA and WDATCP reports compared with the subsequent inspection reports showed comparable regulatory outcomes. The average rate of correction of violations following a routine inspection was not significantly different between WDATCP and FDA. Analysis of uncorrected violations shows room for improvement in following up on the violations noted by the other agency, agencies’ coordinating timing of inspections, and methods used to achieve compliance. The results of this study are evidence of integration and show continued mutual reliance on each other’s inspections is warranted.
Background
An Integrated Food Safety System (IFSS) can address the hazards of foodborne illness and injury more effectively than independently operating regulatory agencies with similar goals (National Food Safety System Project Outbreak Coordination and Investigation Workgroup, 2001; Partnership for Food Protection, 2013; Partnership for Food Protection, 2014). The IFSS concept asserts that by adopting the same best practices, using the same quality standards, and conducting ongoing quality assurance and quality improvement, federal and state manufactured food regulatory programs should be able to rely on each other to effectively and efficiently achieve compliance outcomes and protect public health.
The Wisconsin Department of Agriculture, Trade and Consumer Protection (WDATCP) was formally recognized for adopting regulatory best practices and quality assurance procedures in 2014, when the U.S. Food and Drug Administration (FDA) Office of Operations Audit Staff found WDATCP in full conformance with the Manufactured Food Regulatory Program Standards (FDA, 2016). Also in 2014, WDATCP recognized FDA as achieving comparable regulatory outcomes when WDATCP began counting FDA manufactured food inspections towards the WDATCP workload. Mutual agreement of comparable regulatory effect forms the basis for the Minneapolis District FDA and WDATCP’s current joint implementation of the Partnership for Food Protection’s (PFP) best practices for Local Federal/State Planning and Coordination of Field Operations and Training (PFP, 2013) as part of a Pilot Mutual Reliance Project in the state of Wisconsin. WDATCP has been inspecting on behalf of the FDA under contract for over 30 years, and WDATCP manufactured food inspections are conducted by sanitarians that have received at least 40 hours of FDA classroom training. WDATCP sanitarians are regularly audited to FDA performance standards while performing inspections. However, the agencies’ programs vary, thus a direct comparison of inspectional findings’ effects on firms acting to address violations is warranted to confirm or refute comparability in firms’ future compliance with the law.
Inspections and compliance strategies of the two agencies are similar but distinct. When violations are observed during a routine inspection, both agencies verbally communicate violative findings, or inspectional observations about objectionable conditions to the establishment during an interview with the most responsible person onsite and require that the establishment come into compliance. After an establishment is inspected by WDATCP or FDA and found to have significant or critical violations, the firm is subject to a series of progressively more stringent compliance activities. Both agencies provide written summaries of significant objectionable conditions, which could trigger further compliance. FDA notes and communicates inspectional observations to the firm differently (FDA Investigations Operations Manual, 2016) and does not rely as heavily on re-inspections as WDATCP (personal observation). FDA observations not considered as significant are described narratively in the establishment inspection report and discussed verbally with management upon conclusion of the onsite inspection. When more significant observations, which may result in a compliance action (warning letter), are found, they are communicated to the firm using an FDA 483 form, the notice of inspection observations; the FDA 483 form is given to the firm at the conclusion of the inspection (FDA Investigations Operations Manual, 2016). Firms are encouraged to submit a written response detailing corrections to the observations contained in the 483 form. The WDATCP strategy is also to combine a discussion of inspectional findings at the conclusion of the inspection with written warnings, but WDATCP does not routinely suggest that the firm prepare a written response documenting corrections (WDATCP Inspection Procedures). Another difference with FDA is that WDATCP procedure is to provide the all violative observations in written form whether or not further compliance is warranted.
If further compliance is warranted, in the case of WDATCP, compliance may entail an onsite follow-up or re-inspection, a warning letter, and the payment of a fee for another inspection to ascertain the correction of violations observed. Sanitarians that observe critical, significant, numerous or repeat violations warn establishments of ensuing re-inspections upon conclusion of their violative routine inspection, and a follow-up visit to the firm is a near certainty given critical violations at a firm. In contrast, the FDA investigator does not determine by the end of the inspection that a repeat site visit, accompanied by a re-inspection fee, will follow (FDA Investigations Operations Manual, 2016). FDA inspections generally involve longer time spent in the establishment, and may involve a longer delay between the conclusion of the inspection and the receipt of written inspectional findings in narrative form. WDATCP provides complete written findings in narrative format to the firm within one week of concluding the inspection, whether violations were found or not.
Table 1 summarizes some of the differences and similarities in inspectional procedures and first steps to following up violative routine inspections. The differences in the inspectional and compliance approaches between the two agencies validates the question, are WDATCP and FDA equally effective in achieving their desired effect of inspected establishments correcting the violations their inspection staff observes and communicates during routine inspections?
Table 1
Summary of FDA (FDA 2016) and WDATCP Inspectional Procedures (WDATCP 2007-2016) for Firms with Violative Inspectional Findings Found During Routine Inspections
Problem Statement
The effect of a regulatory inspection on a firm’s future compliance with the law may be different depending on whether FDA or WDATCP does the inspection.
Research Question
1. Is the compliance rate of violations corrected following manufactured food inspections in Wisconsin affected by which agency did the inspection?
Methodology
The rate of correction of violations following FDA and WDATCP inspections was used to measure the effectiveness of the inspection in encouraging future compliance. This rate was defined as the percentage of violations corrected between inspections, as documented in inspection reports from manufactured food firms inspected by FDA and WDATCP since 2014, where at least one violation of 21 CFR 101, 110, 113, 114, 120, or 123, (GPO e-CFR 2017) or equivalent WDATCP provision, was noted. The number of violations that went uncorrected between inspections was also tabulated and analyzed. Time between inspections and compliance follow up activities was recorded for each set of inspection reports analyzed.
To control for two additional factors that may affect degree of compliance—low risk categorization, and Grade A status—manufactured food establishments categorized as low-risk by both agencies (i.e., warehouses), and those that are subject to more frequent “Grade A” dairy plant inspections, were excluded from this analysis.
To calculate degree of corrections, at least one violation must have been noted, and there must have been a subsequent inspection with which to compare. Thus, once the Grade A inspections and low-risk inspections had been eliminated, initial inspections for analysis were selected from those inspections conducted in 2014 or 2015 for which there was at least one violation, and which had received a subsequent routine inspection.
In order to generate a valid interagency comparison, the average degree of compliance that WDATCP achieves between routine inspections of manufactured food facilities, without an intervening FDA inspection was estimated. Estimation was done by analyzing 40 randomly-selected pairs of consecutive WDATCP routine inspections of manufactured food facilities. For the comparison with the FDA, 40 FDA establishment inspection reports from establishments that had received a subsequent routine inspection were randomly chosen and included in the sample if at least one violation was noted. In each case, a random number generator (random.org) was used to select 80 reports such that if an inspection report randomly selected did not qualify for the sample, the report could be replaced by another randomly selected report until 40 initial inspections completed by the FDA were selected and paired with 40 subsequent inspections. Thirty-nine of the subsequent inspections were completed by WDATCP, and one was completed by FDA.
Violations in each report were counted according to the initial report author’s grouping or itemization of violations. Whether or not the report author of the subsequent inspection report made reference to the prior report used in this analysis, violations were counted as corrected as long as they were not listed as observations or violations in the subsequent report. Variables measured in this analysis are listed in Table 2.
Table 2
Comparison of Means, Confidence Intervals, and Proportions of Further Compliance of FDA Followed by WDATCP (FDA) and WDATCP Followed by WDATCP (WDATCP) Routine Inspections
Results
Comparison of the rate of compliance achieved as number of corrected violations divided by total number of observed violations revealed no significant difference in compliance rate between the two agencies. The mean rate for compliance after an FDA inspection was 0.82 ± .08, and the rate after a WDATCP inspection was 0.86±.08 (margin of error at 95% confidence). A paired t-test comparison showed no significant difference in the means (two-tailed p <0.47). Further examination of the average number of violations per establishment, and the percentage of FDA-inspected firms that received a notice of adverse inspectional observations (483 form) or a followed-inspection or re-inspection reveal striking similarities (Table 2). One of the more prominent differences between the two sets of inspections was the average number of days elapsed between inspections. The minimum days between the initial FDA inspection and the subsequent WDATCP inspection was seven, with a range of 682 days between inspections, while the minimum interval between an initial WDATCP inspection and later WDATCP inspection was 128, with a range of 634 days. There were 54 total uncorrected violations, 34 were initially detected by FDA and 20 were initially detected by WDATCP.
Figure 1. Comparison of total numbers of violations detected and corrected.
Three hundred violations were found and communicated to firms during the initial inspections (146 during 40 inspections by FDA, and 154 during 40 inspections by WDATCP). The subsequent inspections of these firms found a total of 329 new violations (328 during 79 inspections by WDATCP and one during one FDA inspection). Thus, though 82-86% of violations were corrected between inspections, caution should be used in concluding that this compliance rate demonstrated full compliance was achieved in the establishments that corrected all previous violations.
Conclusions
The results of this study show comparable compliance outcomes following routine inspections done by the FDA and WDATCP. There was no significant difference in the average compliance rates achieved by the two agencies. This finding supports the validity of mutual reliance on each other’s inspections, demonstrates regulatory equivalency, and documents the emerging Integrated Food Safety System in Wisconsin.
The chief interagency similarity in communicating inspectional findings and expectation of corrections with a firm’s management is the exit interview. This study’s findings serve to emphasize the importance of the exit interview.
The majority of reports analyzed did not explicitly reference the other agency’s report even the other agency’s inspection was the most recently-conducted routine inspection. Only six WDATCP reports made explicit reference to the preceding FDA report, and none of the FDA reports explicitly referenced the most recent routine WDATCP inspection unless the inspection was completed under FDA contract.
Recommendations
The results of this study support four recommendations.
1. First, and most broadly, this study shows that WDATCP and FDA should continue the practices that resulted in the comparable compliance rates shown here. To maintain current levels of integration, both agencies should continue to adhere to current inspection, training, and auditing systems. In particular, the exit interview should continue to be emphasized as the primary way to convey inspection observations and required corrections.
2. The second recommendation has to do with the FDA practice of recommending that firms respond to violative findings in writing to the FDA. The efficacy of this approach is supported by the equivalent compliance rates occurring after FDA form 483 receipt and WDATCP re-inspections. The fact that comparable compliance rates were achieved by both agencies, but only WDATCP made return establishment visits to verify corrections, suggests that perhaps adopting this FDA strategy could improve efficiency of WDATCP resource use. The FDA recommends firms submit written proof of corrective action, in response to violations listed on the FDA form 483. Using this method of documenting compliance could allow WDATCP to reduce the resources WDATCP uses conducting re-inspections while achieving similar compliance rates. In order to save resources and lessen inspection fees charged to the establishments that qualify for re-inspection, WDATCP could implement a requirement that firms submit a written response to WDATCP warnings advising of further compliance action. If the response is satisfactory, WDATCP could forestall re-inspection and save inspectional resources.
3. Third, in order to increase integration and increase compliance rates, FDA and WDATCP should read and refer to the most recent inspection conducted, regardless of which agency conducted the last inspection. To truly inspect as one program, each agency would follow up on the other agency’s findings. More consistently referring to the other agency’s inspection findings and explicitly addressing a firm’s correction of the violations described therein could help detect and more adequately address chronic violations such as roof leaks and equipment repair issues that go uncorrected for two, three, or more regulatory inspections. A way of identifying these violations as “chronic” in reports could help flag accelerated compliance and trigger re-inspections by WDATCP.
4. The fourth recommendation is to continue to improve interagency inspection scheduling. Our Mutual Reliance goal is to space routine inspections by WDATCP and FDA at least five months apart. The occurrence of short intervals between routine inspections demonstrates room for improvement in the agencies’ mutual reliance goal of minimizing duplication of work. Efforts to communicate ongoing updates to work planning should continue; if FDA routinely requested the most recent routine inspection in preparation for their inspections, this could give WDATCP more advanced notice of ad hoc inspections while also improving compliance rates by facilitating following up on recent violations.
Acknowledgments
This research is in support of a Mutual Reliance Pilot Project between WDATCP and the Minneapolis District Office of the FDA. WDATCP conformance with the MFRPS in 2014 was made possible through a Cooperative Agreement with the FDA. I would like to acknowledge Ronesha Strozier, WDATCP Program and Policy Analyst who selected the sample of reports and amassed them for analysis. Dr. Steve Ingham, Division Administrator; Peter Haase, Bureau Director; and Troy Sprecker, Chief of Technical Services, of WDATCP; and Joel Hustedt, State Liaison, and Angela Kohls, Standards Implementation Staff of the FDA, who provided support, programmatic insight, and editorial review. Additionally, the research benefitted from the useful direction and guidance of IFPTI mentors, faculty, and staff, especially Joe Corby and Dr. Paul Dezendorf. I would also like to give a special thanks to each of the Cohort VI Fellows for their feedback and support.
References
FDA. (2016). Investigations Operations Manual. Retrieved from https://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM497756.pdf
FDA. (2016). Manufactured Food Regulatory Program Standards. Retrieved from https://www.fda.gov/downloads/ForFederalStateandLocalOfficials/ProgramsInitiatives/RegulatoryPrgmStnds/UCM523944.pdf
Levinson, D. (2010). Department of Health and Human Services Office of Inspector General. FDA Inspections of Domestic Food Facilities. Retrieved from https://oig.hhs.gov/oei/reports/oei-02-08-00080.pdf
National Food Safety System Project Outbreak Coordination and Investigation Workgroup. (2001). Retrieved from https://www.fda.gov/downloads/ForFederalStateandLocalOfficials/FoodSafetySystem/UCM143338.pdf
Partnership for Food Protection. (2013). Model for Local Federal/State Planning and Coordination of Field Operations and Training. Retrieved from https://www.fda.gov/downloads/ForFederalStateandLocalOfficials/ProgramsInitiatives/PartnershipforFoodProtectionPFP/UCM404722.pdf
Partnership for Food Protection. (2014). Partnership for Food Protection (PFP) Strategic Plan FY 2015 through FY 2020. Retrieved from https://www.fda.gov/downloads/ForFederalStateandLocalOfficials/FoodSafetySystem/PartnershipforFoodProtectionPFP/UCM423834.pdf
U.S. Code of Federal Regulations. Electronic Code of Federal Regulations. (2016). Retrieved from https://www.ecfr.gov/cgi-bin/ECFR?page=browse
WDATCP (2007-2016). Inspection Procedures. Internal Guidance Documents
Wisconsin Administrative Code. (2016). Retrieved from https://docs.legis.wisconsin.gov/code/admin_code