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Colorado Industry Perception of Manufactured Food Regulatory Program Standards

Laura Van Wagenen-Birdsill
Wholesale Food and Recall Program Coordinator
Colorado Department of Public Health and Environment, Division of Environmental Health and Sustainability (CDPHE-DEHS)
International Food Protection Training Institute (IFPTI)
2012 Fellow in Applied Science, Law, and Policy: Fellowship in Food Protection

Abstract

The Manufactured Food Regulatory Program Standards (MFRPS) are a set of standards developed by the FDA, in collaboration with state food agencies, as a guide for continuous improvement for state regulatory food manufacturing programs. The Colorado Department of Public Health and Environment (CDPHE) elected to enroll in the MFRPS in 2008. The initial program assessment occurred in December 2011. One of the gaps identified was in the area of regulatory foundation.  Initial assessment determined that some of Colorado’s laws, regulations, and authorities are not equivalent to those of the FDA. This research explores Colorado food manufacturers’ perceptions about CDPHE inspection uniformity and equivalency as well as the agency’s participation in the MFRPS, and any impact on industry outreach and education activities.

Background

The United States Food and Drug Administration (FDA) partnered with state food agencies to develop the Manufactured Foods Regulatory Program Standards (MFRPS). MFRPS establishes a single, uniform, equivalent, risk-based state and federal manufactured regulatory food safety system.  The MFRPS is comprised of ten component standards for the critical elements of a viable manufactured foods regulatory program.  Key requirements of MFRPS are that states perform an initial assessment to identify any gaps with the MFRPS and use this information to articulate and implement program improvement plans, which are monitored and audited by the FDA.

The Colorado Department of Public Health and Environment (CDPHE) enrolled in the MFRPS in 2008.  FDA completed Colorado’s 18-month Program Assessment Verification Audit (PAVA) in December 2011.  CDPHE’s self- assessment of Colorado’s manufactured foods regulatory program identified gaps and inconsistencies with Standard 1, Regulatory Foundation, equivalence with Federal laws and regulations.

Based on Colorado’s PAVA, Colorado’s current wholesale food regulations are not equivalent to all parts of 21 Code of Federal Regulations (21 CFR) governing food manufacturing.  Colorado currently incorporates by reference nearly all of 21 CFR, Part 110, Current Good Manufacturing Practices in Manufacturing, Packaging, and Holding Human Food.  However, Colorado adopted requirements referenced in the 1998 edition of 21 CFR, Part 110 and therefore are significantly out of date.  Additionally, Colorado’s wholesale food regulatory program does not have the direct statutory authority to enforce sections of 21 CFR governing thermally processed, low acid canned foods, acidified foods, hazard analysis critical control point (HACCP) systems, or seafood (21 CFR Parts 113, 114, 120, 123).  Colorado regulatory staff may enforce these provisions only when acting as a commissioned agent under the state food contract with the FDA.

As a result of the program assessment findings, Colorado has made a commitment to the FDA to work to improve Colorado’s regulatory foundation to achieve equivalency and alignment with the most current parts of 21 CFR pertaining to manufacturing, packing, and holding human food.  In order for Colorado to make these improvements, the Colorado Wholesale Food Regulations Current Good Manufacturing Practice in Manufacturing, Packing or Holding Human Food must be updated.  Colorado’s state statute requires stakeholder involvement for such regulatory changes.

Problem Statement

Colorado’s wholesale food regulations are not equivalent to all parts of 21 CFR governing food manufacturing. There is expressed concern from CDPHE managers that non-equivalency and non-uniformity may adversely impact the quality of inspections. In addition, current education and outreach to Colorado food manufacturers may be inadequate and/or ineffective.

Research Questions

  1. What are the perceptions of representatives of food manufacturing companies registered in Colorado regarding the uniformity of regulatory inspections conducted in Colorado?
  2. What are the perceptions of representatives of food manufacturing companies registered in Colorado regarding the equivalency of regulatory inspections conducted by Colorado Department of Public Health and Environment to inspections conducted by the United Stated Food and Drug Administration?
  3. What are the perceptions of representatives of food manufacturing companies registered in Colorado regarding the impacts of Colorado Department of Public Health and Environment participation in the MFRPS on industry outreach and education?

Methodology

A ten-item electronic survey was administered to a representative sample of Colorado food manufacturing companies using a web-based survey program. The purpose of the survey was to gauge food manufacturing company representatives’ perceptions about the uniformity and equivalence of Colorado’s regulatory inspections among Colorado wholesale food inspection staff as well as inspections of similar types of food manufacturers performed by FDA.  The survey also gauged food manufacturing company representatives’ perceptions of the impacts Colorado’s enrollment in the MFRPS could have on outreach and education.  Additionally, the survey collected basic information about the size of the firm, baseline awareness of the MFRPS, and participation in industry organizations.

The survey was sent to 711 wholesale manufacturers in the State of Colorado registered with CDPHE. Survey recipients had approximately two weeks to complete and submit the electronic survey. Responses to the survey were blind, so that no individual firm could be identified.

Results

Ninety-one surveys were completed, for a response rate of 12.8%The following demographic information was collected in survey question number one, Firm size based on gross annual sales?: Very Small ($0-15,000); Small ($15,001-50,000); Medium ($50,001-150,000); Large (over 150,001).  The Colorado Revised Statute for wholesale food defines these categories for firm registration requirements.  The survey respondent break down was as such: 34 Very Small; 14 Small; 14 Medium; 29 Large.

Approximately 68% of the 91 respondents agreed or strongly agreed that inspections by Colorado inspectors were uniformly conducted.  When data was analyzed to compare Colorado inspection equivalency to FDA inspections, approximately 41% of industry agreed or strongly agreed (Figure 1).

Approximately 56% of the 91 respondents agreed or strongly agreed that state involvement in the MFRPS would have a positive impact on education and outreach to stakeholders (Figure 2).  Approximately 30% of the respondents that agreed or strongly agreed were registered as small and very small manufacturing operations.

Conclusions

The results of this study indicate that the survey respondents, representing food manufacturing companies registered in Colorado, perceive regulatory inspections by CDPHE to be uniform.  Results of the data indicate that the respondents may perceive equivalence in inspections conducted by Colorado state inspectors and those conducted by FDA.  However, further study on this topic may be needed.

The study showed that the survey respondents, representing food manufacturing companies registered in Colorado perceive a positive impact on outreach and education due to their companies’ involvement in the MFRPS.

Recommendations

Improving Colorado’s regulatory foundation to comply with standard 1 of the MFRPS regulatory foundation may significantly change the specific content of Colorado’s laws, regulations and authorities as well as the application by Colorado inspection staff. For these reasons,  the perceptions of food manufacturing company representatives about regulatory expectations,  uniformity, and equivalent application of food safety requirements, may need to be reassessed after full implementation of improvement plans to achieve conformance with the standards has been completed.  Additionally, Colorado should develop and implement a plan to actively engage a larger representation of the food manufacturing industry leadership and management in Colorado through education and outreach.

Acknowledgements

I want to extend my sincere thanks and gratitude to Steve Steinhoff, my IFPTI mentor and his moral support.  I wish to also thank the staff and subject matter experts at IFPTI for this unforgettable and enriching experience.  To my cohort fellows, I thank you for your support and patience through all my unforeseen injuries and health hurdles.  I must also thank the CDPHE for their support.