The undersigned organizations, farms, food businesses, and consumers jointly submit these comments on the Tester-Hagan provisions, also referred to as the qualified exemptions, in the proposed rules under the Food Safety Modernization Act (FSMA).
The Tester-Hagan provisions are vital for protecting vulnerable, small-scale producers that are providing safe, healthy food for their local communities. With the rapidly growing interest in locally produced food, this protection is in the best interest of consumers as well as the farmers and food businesses.
The Tester-Hagan provisions exempt small-scale, direct-marketing farmers and facilities from some of the new requirements imposed under FSMA, specifically the new on-farm produce safety standards and the hazard analysis and risk-based preventative controls (HARPC) requirements. Since the provisions are largely the same in both rules, we will refer to farmers and/or facilities jointly as “producers” unless the comment refers to only one in particular.
Despite the many groups and individuals who urged FDA to implement the Tester-Hagan provision fairly and in a way that fulfills the intent of the law, the agency’s new proposed rules still do not do so.
The proposed rules still fail to provide due process for producers before revoking their exemption. The proposed rules also still impose unnecessary and hasty deadlines for compliance that will effectively shut down any producer whose exemption is revoked. While we recognize and support the agency’s decision to provide a mechanism for the qualified exemption to be re-instated, this provision will do little good if small farms and artisan food producers are forced out of business by a too-hasty or erroneous decision to revoke their exemption and too-short deadlines for compliance.
The proposed rules also still base the size requirements for qualifying for the Tester-Hagan exemption on all the food sold by the producer. Yet the FDA is directed to regulate only certain foods under FSMA, and that the same scope should be applied to the exemption.
Moreover, the FDA has added a new provision in the proposed Hazard Analysis and Risk-Based Preventative Controls (HARPC) rule that could undermine the Tester-Hagan exemption by requiring that facilities conduct a “supplier program.” Not only will the supplier program impose significant costs on the businesses who are subject to it, but it could indirectly impose requirements on, and create barriers for, those farmers and producers who are supposed to be exempt from the HARPC rule under the Tester-Hagan exemption.
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