Concerning: Regulator Preventive Controls Training for State Officials

Whereas, training is an integral part of human resource development and an instrument in developing employees to become more efficient and productive, and

Whereas, in support of a shared and common public health mission, FDA’s Office of Regulatory Affairs’ Office of Training Education and Development (OTED) provides training to state, local and tribal regulatory partners, and

Whereas, FDA has developed and delivers specific regulator training only for state officials who will be conducting independent and FDA contracted Food Safety Preventive Control inspections at regulated facilities to determine compliance with the requirements of the Food Safety Modernization Act (FSMA), and

Whereas, the current training plan for Preventive Controls regulators does not adequately meet demand, but also does not factor in regulator employee turnover, and

Whereas, FDA relies on these state contracted inspections to meet the mandates of FSMA, and

Whereas, AFDO has surveyed state food regulatory agencies to determine their willingness and ability to conduct FDA contracted Food Safety Preventive Control inspections at human and animal food manufacturing plants and what, if any, factors exist that influences their willingness and ability, and

Whereas, this AFDO survey resulted in 40 responses from 38 states (Agriculture & Health both responded for South Carolina and West Virginia), and it revealed a number of states were willing to consider doing some FDA contracted Food Safety Preventive Control inspections at human and animal food manufacturing plants although they wished to begin doing the inspections gradually, and

Whereas, the most commonly cited factors influencing state willingness and ability to conduct FDA contracted Food Safety Preventive Control inspections at human and animal food manufacturing plants was the lack of access to regulator training and staff resources (including how long the inspections take), and

Whereas, AFDO strongly supports the collaboration between FDA and the states to address FSMA mandates and challenges which include Food Safety Preventive Control inspections at human and animal food manufacturing plants, and

Whereas, such collaboration marks another milestone in the development of an Integrated Food Safety System (IFSS) which AFDO very strongly supports and promotes, therefore, be it

Resolved, that AFDO request FDA to work with AFDO to address those influencing factors listed in AFDO’s survey by identifying strategies to resolve these matters (i.e. using alternative training measures and employing triage or trigger based inspections), and be it further

Resolved, that AFDO recommend to FDA that they address the priorities for FDA contracted inspections over the next 5 years, so the states can develop their contract proposals accordingly, and be it further

Resolved, that AFDO requests an urgent need for FDA to develop and provide a management training course to allow for evaluating performance of state regulatory officials who will be conducting the independent Food Preventive Control inspections. Further, these management officials also must be able to explain the technical aspects of the inspections to the policy makers, legal affairs, professionals and respond to other stakeholder concerns.