All domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. must register with the U.S. Food and Drug Administration (FDA), according to the new Food Safety Modernization Act (FSMA).
Registering any time between Oct. 1 and Dec. 31 will keep food companies in compliance with FSMA, according to FDA. Renewal registrations are required every two years in even-numbered years.
There’s been a registration requirement for food manufacturers under the 2002 Bioterrorism Act since Dec. 12, 2003. The FSMA appears to be casting wider net, however. And now registrations can be cancelled for food safety violations.
With FSMA’s start-up regulatory packages held up at the White House, and FDA not doing much talking, some food industry sources are wary about the deadlines that are now approaching.
Florida-based ScoringAg, a pision of Scoring System Inc. which offers full-chain traceability and archiving systems for FSMA compliance, decided to fill that vacuum by sending its clients an email newsletter with some tips in question and answer form. A few excerpts:
Q. What is a food/feed facility?
A. A food facility includes any factory, warehouse (course grain/hay storage, drying or grain cleaning or mixing or conditioning facility) or establishment that manufactures, (mills, or feed grinding/mixing operation) or processes, packs, or holds (bin storage) food or feed. Manufacturing/processing activities include making food (feed or rations) chopping from one or more ingredients, or synthesizing, preparing, treating, modifying, or manipulating food or feed crops or ingredients.
On-farm washing, trimming off outer leaves, and cooling produce are considered part of harvesting and would not require classification as a facility if done on the same day as harvesting. If you hold the harvest in a storage/cooler or warehouse you are a facility.
Q. Which farms are required to register as food facilities with FDA?
A. If you grow it, store it, pack it, ship it.
Farms must register as food facilities with the Food and Drug Administration if they manufacture, process, pack, or hold food/feed beyond what is considered harvesting.
Farmers might be eligible for exemption under the so-called Tester Amendment, named for the Montana senator who sponsored it. That will depend on how FDA defines direct marketing.
And, according to Scoring Systems Inc., there is a long list of activities that will be counted as manufacturing and processing. It’s offering its consultants to help business people with questions as are many others with help the food industry interrupt what’s coming from FDA.© Food Safety News