One of the most controversial elements of the Food Safety Modernization Act was the so-called Tester amendment. It remains a fire starter even today.
There is some speculation that one reason the Office of Management and Budget is taking so long to publish regulations relating to the FSMA is trying to get a better handle on how the exemption for small farms and facilities might apply to foreign entities, since global trade law prohibits discrimination of foreign versus domestic supply in safety regulations. Whether that speculation about the delay in FDA rulemaking is founded or not, I can't say.
I posed a question to the Fresh Produce Industry Discussion Group about the Tester amendment:
Great discussion on both sides of the issue from several thoughtful members.
The issue of how the Tester language would apply to imports was raised - and answered - during the debate over the FSMA.
From a FAQ published by the Western Organization of Resource Councils, a propoent of the language, said this:
Q: Will the amendments open the doors to imports that threaten public health?
A: The Tester-Hagan amendments will improve the safety of our food supply, not hurt it. First, by protecting small, local food producers, the amendments encourage decentralized domestic production instead of reliance on imports. Second, the amendments will not weaken S. 510’s provisions on imports.
The direct farm-to-consumer exemption simply will not apply to importers, who sell their products through long supply chains.
The exemption for small-scale processors only applies to businesses that gross under $500,000 annually, an amount that would not allow large-scale importers to qualify. Large importers who purchase from small companies to consolidate business will still have to comply with the bill’s requirements, including addressing any risks that may derive from their supplies. Moreover, the small business exemption only applies to the requirements of Sections 103 and 204, which involve developing written plans and keeping records.
These paperwork requirements are not the primary or best means for addressing contaminated imported food. For companies importing their products into the U.S., the key public health protection will be on-site inspections and inspections at the border. Exempting small US farms and facilities from S. 510 allows FDA to use its limited resources on inspecting the large facilities (both domestic and foreign) that pose the greater risk to public health.
TK: When the FDA does finally publish the produce safety rule and the foreign supplier verification regulation, considerable attention will be directed to the issue of if and how the Tester language will apply to foreign farms and facilities.
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