Author: Dr. Lauren Gwin, Small Farms Program, Oregon State University
Publish Date: Spring 2014
Add a note to your summer “to-do” list: “Weigh in on FSMA. Again.”
In January, the U.S. Food and Drug Administration (FDA) announced it will revise and then allow another round of public comment on elements of two key Food Safety Modernization Act (FSMA) rules: Produce Safety and Preventive Controls for Human Food. This was welcome news to tens of thousands of farmers and others who had many concerns about the proposed rules and submitted comments during the first round of rulemaking last fall.
FDA expects to publish revised rule language for specific parts of the two rules early this summer, followed by a public comment period. While the summer is a bad time of year for farmers to focus on anything but farming and marketing, we encourage you to learn about and weigh in on the revisions and will do what we can to help.
What will be revised?
FDA only plans to revise and offer alternative approaches for key provisions that raised the most concern: water quality standards and testing, standards for the use of raw manure and compost, animal grazing and animal intrusion, certain requirements related to “mixed-use” facilities, and procedures for the withdrawal of qualified exemptions.
In mid-March, the Agency offered what is effectively a “sneak peak” at the new alternatives they are considering. In response to concerns about the environmental impacts of the proposed rules, FDA will prepare an Environmental Impact Statement (EIS). The first step is “scoping”: making sure they have a full list of topics the EIS must address.
In a Federal Register notice about the public scoping period for the EIS (which ends on April 18) FDA outlined new alternatives for the standards related to water, manure and compost, animal grazing/intrusion, and even the $25,000 threshold for farms to be covered by FSMA at all.
For example, regarding the microbial standard for agricultural water, a new potential alternative is “a flexible water quality standard that allows for adjustment to a specified microbial quality standard based on mitigation steps that occur after application of agricultural water and prior to consumption.” As an example, FDA points to a World Health Organization guideline that differs for leaf crops and root crops.
Regarding the interval required for application of raw manure and compost, a new potential alternative is to use the National Organic Program application intervals.
These and other new alternatives are laid out in Table 1 of the Federal Register notice, which you can find here. [Scroll down to “Tables,” under “Table of Contents,” and click on “Table 1.”]
This Federal Register notice is not, by any means, FDA’s official announcement of the new alternatives it is considering. But it is a preview of things to come. We will keep you posted and offer analysis of the revisions as they become clearer and official.