FDA officials told GAO that they do not plan to meet the FSMA mandate because of funding, and they questioned the usefulness of conducting that many inspections.
A Government Accountability Office (GAO) follow-up study found FDA is not in a position to know what a sufficient number of foreign inspections is to go on and request a possible change in the mandate.
The agency is planning to conduct 1,200 foreign food inspections for the foreseeable future - below scenarios that might satisfy the FSMA mandate to increase inspections each year through 2016.
FSMA inspection mandate
Under FSMA, FDA is to inspect at least 600 foreign food facilities in 2011 and, for each of the next five years, at least twice the number of facilities inspected during the previous year.
FDA completed 1,002 foreign food inspections in 2011, 167% of the FSMA mandate. In 2012, FDA did 1,343 inspections, a 34% increase from the previous year’s number.
During 2013, FDA made 1,403 such inspections, a 4% increase from the previous year but also less than twice the previous year’s number.
The agency had done 1,323 inspections last year, which is more than planned but a decrease compared with the previous two years.
FDA estimated the average cost of a foreign inspection was $23,600, compared with $15,500 for a comparable domestic one.
However, it has not conducted an analysis to determine whether the number of inspections in the FSMA mandate or the lower number of inspections it is conducting is sufficient to ensure comparable safety of imported and domestic food, said GAO.
Without an analysis, FDA is not in a position to know the sufficient number of foreign inspections and potentially request a change.
GAO said it recommends FDA complete an analysis to determine the annual number of foreign food inspections that is sufficient to ensure comparable safety of imported and domestic food - something the agency agrees with.
Foreign office work
FDA created seven foreign offices to help prevent unsafe products from reaching US borders in 2008.
Two years later GAO examined these and found they faced challenges due to an increasing workload and other factors.
In the follow-up report, GAO looked at offices in Canada, China, and Mexico based on the volume of food imports, percentage refused at the border, and the number of food facility inspections for fiscal year 2013, among other factors.
The performance audit was from November 2013 to January 2015.
The US reliance on imported food as a percentage of all food consumed has grown from about 9% in 2000 to more than 16% in 2011.
About 91% of seafood eaten in the US was imported in 2011, said the National Marine Fisheries Service.
The US also imported $4.6bn in fresh vegetables and $3.1bn in fresh fruit (excluding bananas) from Mexico in 2013, according to the Office of the US Trade Representative
In 2010, FDA’s China Office completed 13 food inspections, and the India Office did none.
By 2013, the China Office completed 45 of FDA’s total 59 food inspections in China and the India Office completed all 20 FDA food inspections in India—about 5% of FDA’s total 1,415 inspections of foreign food facilities.
During 2014, the foreign offices completed 140 of FDA’s total 1,323 inspections of foreign food facilities—66 in China, 67 in India, and seven in Latin America.
Officials from the foreign offices gave examples when they had made contributions to determining the cause of outbreaks that led to illnesses and deaths in the US.
“The Europe Office credited new relationships with their Italian counterparts for providing information that helped link a 2012 outbreak of listeriosis, which sickened 22 people and resulted in four deaths in the US, to ricotta cheese imported from Italy.
“According to FDA officials, the office staff worked with Italian food safety authorities to investigate firms that could have caused the outbreak. The result of these efforts was a recall of some ricotta cheese, ending instances of illness and death in the US.”