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Majority of FDA-registered food facilities now outside the U.S.

A majority of the food facilities required to register with the U.S. Food and Drug Administration are now located outside of the United States.

Registrar Corp., based in Hampton, VA, says a response it received from FDA under a Freedom of Information Act (FOIA) request shows 207,655 food facilities were registered as of Jan. 1, 2016.  More than half — 120,822 — are outside of the United Sates.

USA_cutout_GRAPHIC_406x250All food facilities that manufacturer, process, pack or store food, beverages or dietary supplements for consumption in the U.S. are required to register with FDA.  The new data shows 86,773 of them, just less than 42 percent, are in the U.S.

However, U.S. facilities account for more than 80 percent of the food Americans eat. Food from foreign sources is enjoying rapid growth in the U.S., though.

In addition, spokesmen for Register say the number of registered food facilities reported in the FOIA document is significantly lower than the 300,539 found on FDA’s Food Facility Registration Statistics.  FDA says the difference exists because one facility can be listed multiple times in the agency’s  statistics if it is involved in more than one activity.

Registrar Corp., which consults with companies about FDA issues, says registration numbers have been fluctuating. For 2016 they are up 24 percent compared with 2015 registrations, which were down 14 percent compared with 2014. The data suggests food businesses are failing to renew their registrations, especially those located in the United States.

“In our experience, domestic facilities often fail to renew at all, or to renew on time, for a fairly simple reason: Unlike foreign facilities, U.S.-based manufacturers do not have to notify FDA prior to making a food shipment, whereas foreign facilities are required to file an FDA Prior Notice (which includes the manufacturer’s registration number) prior to arrival of a shipment of food into our ports of entry,” said David Lennarz, vice president of Registrar Corp.

“In essence, FDA has no way to ‘catch’ the U.S. firms who simply fail to renew,” Lennarz told Food Safety News. “They may be caught by FDA during random inspections, but we all know FDA, and its state partners only inspect a small percentage of facilities, and once you are no loner registered with FDA you would no longer exist in their inspectional database.”

Since Oct. 1, 2012, all domestic and foreign food facilities have been required to register with FDA under the Food Safety Modernization Act (FSMA). The annual registration period runs from Oct. 1 to Dec. 31, with renewals required every two years during even-numbered years.

Food manufacturers were first required to register with the federal government under  the 2002 Bioterrorism Act, which was adopted after the 9/11 attacks and took effect on Dec. 12, 2003.

Americans each annually consume about 2,000 pounds of food, according to USDA, and currently about 19 percent of that, roughly 390 pounds per person, comes from foreign sources. U.S. food imports have increased by about 300 percent since the North American Free Trade Agreement (NAFTA) was adopted.

In anticipation of continued growth of food imports, the FSMA of 2011 requires foreign and domestic food facilities to comply with the same safety standards.

The FSMA’s rules, now final, on foreign supplier verification and accreditation of third-party auditors are among the preventive tools FDA now has to make sure food imported to the U.S. is safe.

The Top 10 countries in terms of the the number of FDA registered food facilities they have are:

  1. United States 86,773
  2. Japan 13,941
  3. France 10,450
  4. Italy 10,125
  5. China 9,667
  6. Mexico 9,575
  7. Canada 6,690
  8. Spain 4,688
  9. Republic of Korea 3,921
  10. India 3,455

Registrar Corp. has published a list of all 207,655  FDA registrations by country here.

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