Posted November 13, 2013
In October, the U.S. Food and Drug Administration (FDA) released the most recent revisions from the Office of Management and Budget (OMB) on proposed rules under the Food Safety Modernization Act (FSMA), prompting a negative response from consumer advocates according to a Food Safety News article available here. OMB review documents are available here.
The proposed rule for Foreign Supplier Verification Programs was changed significantly. In the original draft of the rule, the FDA planned to require on-site audits for foreign suppliers. OMB’s Office of Information and Regulatory Affairs (OIRA) offered two options in the alternative: “The first would require on-site audits for the most serious hazards while importers get to choose how to verify others. The second would allow the importer to choose the verification method for everything.”
OIRA also added an exemption to the rule for “very small importers” and “very small foreign suppliers” only requiring a written statement of compliance. FDA estimates that 59 percent of process food suppliers and 93 percent of raw produce suppliers would fit into this category.
Michael Patoka, policy analyst for the Center for Progressive Reform, said that OIRA’s changes “produce pretty gaping holes in the rules coverage and expose Americans to a greater risk of foodborne illness from imported foods.”
“Changes made by an agency to a rule while it is under review at OIRA may happen in response to comments or information from a wide range of stakeholders – including the public and agencies across the U.S. government (including the agency that drafted the rule),” according to an OMB spokesperson.
The public comment period for the proposed rules is scheduled to end Nov. 26, but a 60-extension will be announced soon.
For more information the Food Safety Modernization Act, please visit the National Agricultural Law Center here.
Share: