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.
