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The FDA has extended the comment period for the new rules to September 16 for two new proposed rules for the implementation of the Food Safety Modernization Act. They give new power to the FDA to revoke exemptions from burdensome regulations that the Act gives to facilities and small farmers whose annual local food sales are less than $500,000.
It allows FDA to revoke the exemption if a foodborne illness outbreak might possibly be linked to the farm, even if there is no proof that the farm is the cause of the outbreak, and even though there may not be an immediate threat to public health. There is no formal hearing process in which to contest the decision—and no way to re-qualify for the exemption. In addition, the proposed rules discriminate against small farmers and food producers who wish to diversify. The rules now say that all foods sold by farmer or food processor fall under the $500,000 cap, instead of just the food that is under the FDA’s jurisdiction and therefore subject to the FSMA.
Write to the FDA and ask the agency to create a clear and justifiable standard for revoking the exemption for small farms and facilities, not the vague language that is currently used; allow for due process to contest the decision; provide a pathway to re-qualify for the Tester-Hagan exemption; and limit the definition of food in the $500,000 sales ceiling to those products under the jurisdiction of the FSMA and the FDA.
Please personalize and add your own comments if you have time!
Dear [Decision Maker],
Sincerely,[Your Name] [Your Address] [City, State ZIP]