International development and capacity building for the implementation of food safety regulations in produce: A focus on the Food Safety Modernization Act
Arteaga Arredondo, Gabriela Alejandra
On January 4th, 2011, and due to the re-occurrence of foodborne illness outbreaks linked to imported food, and market disturbance, The Food Safety Modernization Act (FSMA) was signed into law, becoming the most impactful modification on the food inspection system in the United States in the last 7 decades. This study focused on the Produce Safety Rule and the Preventive Controls Rule for Human Food, both part of the FSMA legal framework. The general objective of this study was to develop a systematized approach to address the requirements on the regulations established by FDA. The secondary objectives of this study to develop the mentioned approach, were to develop two diagnosis tools to evaluate the preparedness in regards to the Produce Safety Rule and the Preventive Controls Rule, and their respective validations in the Central and South American regions, and the Caribbean. A total of two diagnostic tools were generated, and the Produce Safety Rule Tool was validated in 11 countries. As a result of this validation, a needs assessment was developed per region with the most important needs detected at Subpart B which related to General Requirements, Subpart C on Personnel Qualifications and Training, Subpart D for Health and Hygiene, Subpart E which focuses on Agricultural water, Subpart N on Analytical Methods, and Subpart O for Records. This same methodology was applied to address the Preventive Controls Rule through a case study in Mexico, in a frozen-broccoli processing plant. The Preventive Controls Rule Tool was applied to assess the needs that the facility had in order to progress towards the preparedness level on this rule. The facility had a 55% of preparedness level at the beginning of the study and finished up with a 62% as a global score. The technical assistance offered to this facility was focused on Good Manufacturing Practices (GMPs), documentation, the development of a microbial profile of their complete process, and the validation of their elimination step, considered as the blanching process. Among the documents that were generated for the processing plant, a Food Safety Plan was developed for the facility. Additionally, the personnel received certificates of achievement as Preventive Controls Qualified Individuals, provided by the Food Safety Preventive Controls Alliance. In terms of the assistance related to microbiological status of the plant, the microbial profile showed that the area that needs more attention in regards of GMPs is the receiving and chopping areas. As a consequence of the microbial profile, the in-plant validation was performed using E. coli surrogates, which resulted in a significant reduction (P<0.05) of 5 log (CFU/g), validating the process as a killing step.