FDA Cannot Implement FDSA
As foretold (Article #1, Article #2) the Food and Drug Administration (FDA) recently released a report to Congress stating the agency cannot implement the Food Safety Modernization Act (FSMA) without additional funding. For FY 2011 & 2012 Congress provided FDA with an additional $100 million for implementation of the law that provides the most comprehensive reform of our food safety laws in more than 70 years. President Obama signed FSMA into law on January 4, 2011. The ideas behind FSMA are to ensure the safety of the U.S. food supply by shifting focus from responding to food contamination to preventing it.
FDA Shifting Focus From Responding to Food Contamination to Preventing It
In their report FDA said, “The promise of FSMA to reform food safety in the U.S. and to significantly reduce the burden of foodborne illness cannot be realized without additional funding. Taking into account the projected resource needs from the Congressional Budget Office and new funds appropriated from FY2010 through FY2012, FDA will need an additional $400 million to $450 million in funds added to its (budget) base(line), to make FSMA a fully successful initiative.”
10% -15% of all food consumed by U.S. households is imported from abroad
FDA also cited the impact of the lack of funding on FSMA’s more proactive inspections relating to imported foods. “For foreign inspections, FDA has increased its coverage to 1000 foreign food facilities in FY 2011 and 1200 foreign inspections in FY 2012. The agency does not expect to go significantly beyond that level in the foreseeable future. Reaching the goal of 19,200 foreign inspections called for by FSMA would require hundreds of millions of dollars in new funding, which the agency cannot realistically expect to receive.” Currently, between 10% and 15% of all food consumed each year by U.S. households is imported from abroad.
Now entities throughout the food supply chain, from production agriculture (field) to food services (fork) will be left in an uncertain regulatory abyss for the foreseeable future on the extent and depth of FDA’s inspections and enforcement that will be based upon if/how much money Congress can scratch up each year for FSMA implementation. Such regulatory uncertainties created from such massive reforms as FSMA will prove costly and drive up costs for industry and suppress hiring and investment.
So who will really end up paying for the FSMA implementation?
Consumers, through higher food costs passed along the supply chain.
The Senate continues debate on the Farm Bill the week of June 3. There are numerous amendments the Senate is considering including two that block or delay FSMA implementation. Specifically, an amendment offered by Senator Angus King (I-ME) delays FSMA implementation and requires FDA to study the impacts on farms by size and on local and regional production and markets.
An amendment offered by Senator Mike Crapo (R-ID) would block FDA from establishing standards for growing and handling fruits and vegetables that are eaten raw.
It remains uncertain if Senate Agriculture Chairwoman Debbie Stabenow (D-MI) will rule the amendments germane to the Farm Bill as FDA is an agency under the Department of Health and Human Services. The Senate Committee on Health, Education, Labor, & Pensions may want to review the proposed amendments.
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