The Food and Drug Administration reported on its progress with food safety initiatives May 23, stopping short of saying many requirements of the Food Safety Modernization Act are unfunded mandates for the agency and its state and local counterparts.
In a statement accompanying a report to Congress, FDA deputy commissioner for foods Michael Taylor said the FSMA cannot be implemented without additional funding.
Taylor reminded lawmakers that the Congressional Budget Office estimated the first five years would require at least $583 million more than FDA’s 2010 base budget by 2015. That estimate did not include investments in technology, federal-state integration and a new import system.
Taylor“Rules can be written but they can’t be implemented effectively and efficiently with current funding,” Taylor wrote in his preamble to the report, acknowledging that Congress added $100 million to the FDA’s base budget in fiscal years 2011 and 2012.
“We estimate that FDA will need an additional $400 million to $450 million in funds added to its FY 2012 base to make FSMA a fully successful initiative. The President’s 2014 budget proposal, if enacted, would make a significant contribution to funding FSMA implementation.”
Budget increases in recent years have “almost permitted FDA to return to its inspection level of a decade ago domestically,” according to the report, but to meet the FSMA mandates for inspections of foreign food facilities “substantial additional funds will be necessary.”
The number of required inspections and the lack of modern technology to analyze data make it impossible for FDA to meet the FSMA requirements, especially when foreign facilities are included, according to the report.
The FDA estimates there are 22,325 high-risk food manufacturing facilities in the U.S., which include some fresh produce operations. The agency estimates there are 150,000 produce growers in the U.S.
The FSMA requires FDA to inspect all high-risk operations at least once in the first five years after the 2011 enactment of the Act. According to the report the FDA will have completed those domestic high-risk inspections in three years.
However, reaching the goal of 19,200 foreign inspections mandated by the FSMA would “require hundreds of millions of dollars in new funding, which the agency cannot realistically expect to receive,” according to the report. The FDA says 50% of fresh fruits and 20% of fresh vegetables consumed in the U.S. are imported.
Agency applauds produce industry traceability efforts
Traceability mandates will also be impossible to meet without more money, according to the FDA report.
“FDA cannot be in the position of requiring or approving a specific tracing system or systems,” according to the report. “The produce industry has appropriately taken a leadership role with instituting several initiatives to improve tracing produce through the supply chain; however, there is inconsistent adoption by industry.”
Those initiatives have improved response times during produce-related outbreaks, according to the report, but data collected during outbreaks cannot be used efficiently because of antiquated information technology at the federal, state and local levels.
“Significant challenges exist in tracing produce and other foods in an outbreak,” according to the report. “There are several reasons for this including drastic cuts in state and local budgets.”
Even if the FDA and state and local agencies had enough money for current technology, there are other roadblocks.
“FDA is limited by statute in its ability to share certain types of information even with our state and local partners. … legislative changes to our ability to share critical information during an emergency may be necessary” the report states.