In October of 2019 the FDA held a public meeting to discuss A New Era of Smarter Food Safety. Many ideas, concepts and agendas were introduced but for this article, I want to focus on just one. How implementation would be regulated.
The meeting opened with remarks from Frank Yiannas, a food safety expert serving as FDA Deputy Commissioner of Office of Food Policy and Response. “We’re going to build on the progress that we’ve made implementing the Food Safety Modernization Act….. In FSMA congress anticipated the need for enhanced tracking and tracing of certain foods. And part of the work the FDA will do in modernizing food traceability will come through rulemaking under the development that’s required in this section 204 of the law. It requires FDA to designate certain foods for which additional records are needed.”
So what is FSMA? FSMA stands for Food Safety Modernization Act, and congress passed it back in 2011, handing the FDA quite of bit of regulatory power. I’ll link the text of the bill, as well as the FDA’s meeting at the bottom if you would like to read through it yourself. Frank Yiannas mentioned the section regarding recordkeeping as a way to usher in changes, so today I wanted to lay some ground work by answering a couple of questions. First, what type of record keeping is already required? (linked in previous article with the FDA’s Guidance, will also link down below) and second, who is required to keep these records?
What type of records are already required? A farmer needs records of every crop grown, with variety names, as well as each of their growing locations with specific identifiers like field numbers, geographical markers, or GPS coordinates. Date and times when each crop is harvested, what growing location it came from, what tools were used to harvest, then what holding/packing/cleaning facility it went to and if applicable, what transport vehicles were used. The farmer also needs to keep records with dates and times of how all of the tools, equipment, transport vehicles and buildings are cleaned and sanitized. With these, cleaning methods used for each and concentrations of said cleaning and sanitizing solutions. Then within a decent amount of time, although decent amount isn’t defined, all of these activities must be signed off by an approved supervisor or personnel. If a farmer composts their own soil amendments of biological origin (manure, eggshells worm castings, or other animal origins), they will also need detailed records of the composting process. Date and time when the process was started, materials used, carbon to nitrogen ratio, and location of the compost. Date and time records for every temp reading, and every time the pile is turned. Date of every time moisture is added and PH readings, if an insulating layer is added, and then dates of when the composting process is finished and when curing is complete. Records of training personnel are also required, but luckily they aren’t nearly as stringent. The FDA says to keep all these records for two years from the last date entered for that season.
Now we know what records are required, let’s find out who is required to keep them. Down below, you will find a link titled RCR, Rarely Consumed Raw produce. If what a farmer grows and/or sells is not on this list, then they are subject to these record keeping requirements. Keep in mind the FDA has the freedom to alter this list as they see fit. The other determining factor is the size of a farmers business, Large Farm, Small Business, or Very Small Business.
Large Farm: on a rolling basis, the average annual monetary value of produce sold during the previous three years is more than 500k.
Small Business: on a rolling basis, the average annual monetary value of produce sold during the previous three year period is more than 250k but not more than 500k.
Very Small Business: on a rolling basis, the average annual monetary value of produce sold during the previous three year period is more than 25k but no more than 250k.
There are “qualified exemptions” offered if a majority of sales are direct to consumer, as well as a few other criteria that can be found in the guidance draft. This is their one leg in the door to complete control of our food system and diets; but more on that with the next installment.