Annual burden hours

The US. Food and Drug Administration on March 13 put out notice asking for comments on the draft final guidance, the "Guide to Minimize Food Safety Hazards for Fresh-Cut Fruits and Vegetables"

From the notice:

Currently, the fresh-cut trade association estimates that there are 250 fresh-cut plants in operation in the United States. While most of the recent growth in the fresh-cut industry has been due to mergers between already existing firms, there are approximately 50 fresh-cut plants that did not exist in 2001. This implies that about 10 new firms are entering the fresh-cut industry each year. Many of the existing firms in the fresh-cut industry already make use of CGMP-related, recall, HACCP, and other activities. FDA estimates that the burden of this draft final fresh-cut guidance will fall on both existing and new firms entering the industry who may follow the recommendations in the guidance.


More from the notice:

A typical fresh-cut processing plant operates about 255 days per year. For an 8-hour shift, assuming the ingredients are received twice during that time, under the recommendations in the draft final guidance, there would be about 13 records kept (2 for inspecting incoming ingredients; 2 for inspecting the facility and production areas once every 4 hours; 3 records for equipment (maintenance, sanitation, and visual inspections for defects); one for calibrating equipment; 2 temperature recording audits (1 time for each of the 2 processing runs); and 3 microbiological audits (ingredients, food contact surfaces, and equipment)). Therefore, the annual frequency of recordkeeping for SOPs and SSOPs is calculated to be 3,315 times (255 x 13) per year per firm; 110 firms will be performing these activities to generate a total 364,650 records (3,315 x 110) annually, assuming all firms choose to follow the recommendations on keeping records. The total time to record observations for standard operating procedures and sanitary standard operating procedures maintaintenance is estimated to take 4 minutes or 0.067 hours per record, and the number of records maintained is 364,650. Therefore, the total annual burden in hours for 110 processors to maintain their SOP and SSOP records is approximately 24,432 hours.

TK: The FDA says that summing up all the requirements, the estimated one-time record keeping burden for firms that choose to follow the recommendations is 18,700 hours; the annual burden for firms, existing and new, is estimated to be 41,605 hours. That's a nifty $832,100 at $20 per hour. The cost of consumer confidence?