In written comments submitted to the Food and Drug Administration regarding voluntary submission of facility profiles, IDFA commended the agency’s willingness to use a voluntary process, but said the proposed scope of information to be collected is overly broad and should be scaled back.
This spring, FDA announced plans to modify the food facility registration process as a part of its implementation of the Food Safety Modernization Act. The agency proposed that companies submit on a voluntary basis a "facility profile" with operational details about their plants so the agency can prepare for inspections in advance, reduce inspection times and create a database of products, hazards and preventive controls. FDA said the type of information the profile would gather included the type of facility, products and hazards, and preventive control measures associated with those products. The voluntary profile also would ask about food safety training, facility size, operational schedule and number of employees.
“FDA would both reduce the burden on industry and enhance the quality, utility and clarity of the information collection were it to narrow the scope of information requested,” IDFA said in its written comments. “In particular, we recommend that FDA scale back the amount and type of information requested to include only information regarding facility type, size, operating schedule and products.”
FDA plans to use the information in the voluntary submission to determine whether a facility is high risk or non-high risk and to help determine inspection frequency for each type. The agency would use the searchable database when a problem occurred with certain foods or controls to target inspections to facilities at increased risk.
For more information, contact Clay Detlefsen, IDFA vice president of regulatory affairs at firstname.lastname@example.org.