The Food and Drug Administration has OK’d Daniella-brand mangoes to enter the U.S. following a 2012 salmonella outbreak traced to the company’s Mexican fruit, but the process did not include on-site testing by FDA inspectors because of “travel restrictions.”
FDA media affairs specialist Pat El-Hinnawy said the Los Mochis, Mexico, company Agricola Daniella was removed from an import alert list June 26. The list effectively bans companies from exporting to the U.S. until measures correcting problems have been met.
The FDA put the company’s mangoes on the “detention without physical examination” list in September 2012 because of a 15-state salmonella outbreak that ultimately sickened 127 people in the U.S., according to the Centers for Disease Control and Prevention. No deaths were linked to the fruit, but 33 people required hospitalization.
“In order to be removed from the import alert, the firm submitted documentation to FDA demonstrating that it had made all relevant corrections to overcome the appearance of adulteration. The agency reviewed the firm’s corrective actions and found them to be acceptable,” according to the FDA.
The State Department issued travel warnings because of drug-related violence in Mexico.
The FDA does not make a public announcement when a firm is removed from the import alert list, El-Hinnawy said. FDA officials did not provide details on what problems Agricola Daniella addressed.
“Throughout the case, FDA communicated directly with the firm to address the outbreak, including potential causes of the contamination,” according to a statement from FDA.
“The firm was proactive and identified potential routes of contamination. It took corrective action to overcome the import alert and help assure that future shipments would be in compliance with FDA requirements and regulations.”
Agricola Daniella director Daniel Ibarra said “FDA, never gives specific do’s and don’ts. What every company has to demonstrate is that your product is safe for consumption.”
He said the company invested “a lot of money in food safety equipment to have not only what is required but to have the most advanced system in food safety — Automated Control System.”
The company now has stainless steel equipment, improved records, scientific investigations and analysis of soil in its plantations and products, Ibarra said July 11.
“We met with FDA in person, we did a presentation of our improvements. We have certified all our crops, and our packing shed by more than two (food safety) companies.”
U.S. distributor selling Daniella mangoes again
Larry Nienkerk, founder and general manager of Splendid Products, Burlingame, Calif., said July 11 he had already received and shipped Daniella brand mangoes to U.S. customers. He said none of his customers refused the fruit.
“We are in our 18th year of working with this company and are very proud how they have handled the situation,” Nienkerk said. “They have food safety certifications and in recent days just got an impossibly high score of 98 on their field inspections.”
Splendid Products recalled about 250,000 9-pound boxes of Daniella mangoes in August 2012 after health officials in Canada, California and Washington state linked the fruit to salmonella outbreaks.
A string of recalls followed from other distributors, retailers and fresh-cut processors. The other distributors in the U.S. were Coast Citrus Distributors Inc. of San Diego, Food Source Inc. of Edinburg, Texas, and GM Produce Sales, Hidalgo, Texas, according to the FDA website. Calls to Coast Citrus seeking comment were not immediately returned.
At least 23 people in Canada were also reported sick with the same strain of salmonella after eating Agricola Daniella mangoes in summer 2012. The Vancouver-based distributor North American Produce Sales recalled the Daniella fruit two days before recalls began in the U.S.