Preparing for the Implementation of a Routine Inspection Program in Colorado
Nicole K. Berzins, MS
Environmental Protection Specialist
Colorado Department of Public Health and Environment
Division of Environmental Health and Sustainability
International Food Protection Training Institute (IFPTI)
2014 Fellow in Applied Science, Law, and Policy: Fellowship in Food Protection
Abstract
Recently, Colorado took steps to develop a routine inspection program of wholesale manufacturing firms. This proactive approach by the state is consistent with the overall preventive approach of the Food Safety Modernization Act (FSMA); however, in order for the new routine inspection program to be most effective, input from the firms being inspected is needed. This study analyzed the responses to questions posed during two focus group sessions representing a range of wholesale manufacturing operations: 1) larger firms with significant business experience and with access to local or county health departments, and 2) smaller operations with less business experience and with limited or no access to local or county health departments. Focus group participants were asked a series of questions related to regulatory guidance and information, and a content analysis of the focus group discussions was conducted. A majority of participants from both focus groups felt it was difficult to understand regulatory language, and was confused by local and state requirements. Various sources of guidance and information were mentioned, but most participants indicated these sources were not helpful. Based on the focus group discussions, there is a need for more effective outreach efforts on the part of local and state regulatory bodies. Enhancing these outreach efforts will better prepare wholesale manufacturing operations in Colorado for the state’s new routine inspection program, and will help these firms become FSMA-compliant.
Key terms: Colorado Department of Public Health and Environment, information, industry partnership, integrated food safety system (IFSS), routine inspection program, support, wholesale manufacturing operations
Background
Illness and hospitalizations related to foodborne illness continues to be a concern in Colorado, especially since the multistate outbreak of listeriosis caused by cantaloupes from the state. The outbreak caused 147 illnesses, including 40 in Colorado (CDC 2012). Colorado currently inspects just 25% of the registered food manufacturing firms in the state, either through Food and Drug Administration (FDA) contract inspections, food defense inspections, or inspections resulting from complaints, recalls, certificate of free-sale requests, and firms found to be in noncompliance from previous FDA inspections. However, the Colorado Department of Public Health and Environment (CDPHE) is in the beginning phases of developing a routine inspection program for wholesale manufacturing operations in the state, a plan that mirrors the proactive approach to food safety taken by the Food Safety Modernization Act (FSMA). Successful implementation of the routine inspection program, however, requires study of how wholesale manufacturing operations feel they can best benefit from the state program.
Problem Statement
It is not known what type of support wholesale manufacturing firms in Colorado would like a routine state inspection program to provide them.
Research Questions
1. How do wholesale manufacturing operators in Colorado obtain information related to food safety requirements?
2. What types of support do wholesale manufacturing operators in Colorado want from state regulatory bodies?
Methodology
Individuals representing wholesale manufacturing operators were invited to participate in two focus groups where the individuals could share perspectives and opinions related to the types of regulatory support that would benefit their operations. Two focus groups were conducted involving a total of twenty-two (22) participants. Focus Group 1 represented 12 larger wholesale manufacturing firms with direct access to local or county health offices. Focus Group 2 represented 10 smaller wholesale manufacturing firms located in parts of the state where access to county health offices was limited or unavailable. Participants in Group 2 generally represented firms in more rural and remote locations in the state. The firms represented by the focus groups had business experience ranging from more than twenty years to less than one year.
Each focus group consisted of 45 to 60 minutes of questions and answers, along with conversation, all of which was recorded. A qualitative analysis of the focus group transcripts was conducted to determine the frequency by which certain concepts and ideas were raised.
Specific questions for the focus groups included, but were not limited to the following:
1. How do operators know about regulatory requirements in Colorado?
2. How do operators prepare for state inspections?
3. How do operators find information pertaining to regulatory requirements?
4. What was most helpful or not helpful about the information found?
5. What support do industry partners most want and need in order to best comply with regulatory requirements?
Results
A majority of focus group participants - regardless of having access to local or country health departments - indicated confusion concerning local and state regulatory requirements, and difficulty with understanding regulatory language. Additionally, a handful of participants indicated that having access to third-party auditors - consultants from non-regulatory agencies - was insufficient in helping the participants understand food safety regulatory requirements (see Figure 1).
Over 85% of the twenty-two participants indicated a desire for a supportive approach to regulating wholesale manufacturing operators, i.e., having CDPHE provide operators with guidance, information, and other regulatory support to assist with regulatory compliance. However, focus group participants representing firms with less than five years of experience indicated they had no idea that CDPHE offices could provide support on various aspects of their business, or that firms could reach out to CDPHE for assistance with, for example, label reviews.
When asked how regulatory information is obtained, the most common responses from the focus group participants included “other manufacturers” and “industry customers,” suggesting that wholesale manufacturing firms in Colorado are looking to non-regulatory bodies for assistance and guidance. Additionally, participants who indicated receiving information from regulatory bodies such as FDA and CDPHE felt that the information was not very helpful.
When asked what types of support operators need in order to best comply with food safety regulatory requirements, similar topics emerged from both focus groups. Having an “inspection checklist” regarding the inspection process, along with having access to user-friendly websites, newsletters, or brochures, was determined to be most supportive, especially among the firms that did not have dedicated quality assurance staff. Other means of support included training sessions on food safety, guidance on federal, state, and local food safety regulations (to clarify jurisdictional issues), and training or guidance on Hazard Analysis and Critical Control Points (HACCP). Participants representing firms with lesser business experience, however, specifically mentioned a need for a “start-up business packet” (see Figure 3).
Conclusions
This research addresses the perspective of wholesale manufacturing operators in Colorado regarding regulatory information and guidance, along with an insight as to the types of information and guidance needed to help firms better prepare for the routine inspection program that will soon be implemented in the state. Although the research findings are limited to comments from twenty-two individuals representing a variety of wholesale manufacturing firms in the state, the researcher has drawn the following conclusions.
Food safety regulatory information is difficult to understand and often confusing, and having access to a third-party auditor may not be sufficient to help firms understand food safety regulations and requirements.
Wholesale manufacturing operations in Colorado, especially smaller operations with less experience, may be unaware that CDPHE can provide regulatory assistance and guidance.
Wholesale manufacturing operations in Colorado may be turning to non-regulatory bodies such as other manufacturers and industry customers for information and assistance related to food safety regulations and requirements. Additionally, information currently being obtained from regulatory bodies (FDA, CDPHE) may not be helpful.
Wholesale manufacturing firms may prefer to receive regulatory guidance and assistance through specific formats such as newsletters, websites, checklists, and informational packets, especially for firms with no dedicated quality assurance staff.
These conclusions suggest that, from an industry perspective, there is a need for an increased role by CDPHE, along with local and county regulatory bodies, as the routine inspection program undergoes implementation across the state.
Recommendations
Based on the conclusions drawn from the research findings, the following recommendations should be considered.
This research should be expanded to capture information from a wider group of participants. This expansion can be done by conducting additional focus groups, or by developing an electronic survey that can be sent out to the manufacturer database(s). The research should also be expanded to include additional sectors in Colorado such as retail food establishments and produce growers.
CDPHE should form partnerships with agencies from other states in the process of implementing a similar routine inspection program. Such interstate partnerships can allow for information-sharing, and can help prevent Colorado from operating within a vacuum.
CDPHE should create a new staff position of public information officer. This individual (or these individuals) would be tasked primarily with building partnerships between CDPHE and local/county health offices, and bringing feedback to CDPHE on regulatory issues from the local or county level. The public information officer(s) should also help inform manufacturing operations of the routine inspection program, especially smaller operations with limited access to local or county offices.
Baseline data should be established regarding the number of reported foodborne illnesses within the state, along with data on the number of violations found during inspections. Establishing the baseline will help CDPHE gauge the effectiveness of the routine inspection program over the coming years.
CDPHE should determine the current level of information accessible to wholesale food manufactures and, based on those findings, create updated guidance documents, training, and additional outreach material to assist firms in becoming “inspection ready.”
Finally, CDPHE should develop stronger partnerships with other state regulatory agencies that have an impact on wholesale food manufacturing operations in the state. Potential state agency partners include the Secretary of State, the Colorado Department of Revenue, and/or the Colorado Department of Agriculture.
Acknowledgments
I would like to express my gratitude to the following people: the International Food Protection Training Institute (IFPTI) for the opportunity to participate in the Fellowship and bring this message to those involved with developing new routine inspection programs in Colorado and across the U.S; my supervisor, Mrs. Susan Parachini, Colorado Department of Environmental Health and Environment, for unwavering support and encouraging me to ask hard questions; Dr. Paul Dezendorf for his passion in helping the IFPTI Fellows succeed; the Cohort IV Fellows for their unwavering support and friendship; Dr. Joanne Brown for her support and confidence; the Colorado food manufacturers that dedicated their time and partnership in gathering my research data; and last, but certainly not least, my husband, Mr. Samuel Schiller, for his support and encouragement.
References
Krueger, R.A. & Casey, M.A. (2009). Focus groups: A practical guide for applied research (4th ed.). Thousand Oaks, CA: Sage.
Stewart, D.W., Shamdasani, P.N., & Rook, D.W. (2007). Focus groups: Theory and practice (2nd ed.). Thousand Oaks, CA: Sage.
U.S. Centers for Disease Control and Prevention. (2012). Multistate outbreak of listeriosis linked to whole cantaloupes from Jensen Farms, Colorado. http://www.cdc.gov/listeria/outbreaks/cantaloupes-jensen-farms/082712/