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  1. From a Global Perspective

FDA’s Unwavering Commitment to Our Public Health Mission: Reflections on the 30th Anniversary of a Defining Public Health Moment

January 10, 2020

By Anna Abram, Judith A. McMeekin and Vanessa Burrows

Every day, FDA colleagues work tirelessly in pursuit of our mission to protect and promote the public health. Today, we remember two colleagues that we lost in service of this mission on January 10, 1990, when they were tragically killed in a plane crash in the Andes while on an inspection tour of Chile’s fruit-growing regions.

The deaths of John Harty Jr., director of FDA’s international affairs staff, and Patrick Pouzar, director of the investigations branch in the Nashville district office, were a very sad consequence of what had been a contentious and highly-publicized incident of product tampering that resulted in a potential threat to American consumers, millions of dollars in losses for Chilean exporters and a lawsuit against the FDA.

John Harty Jr., director of FDA’s international affairs staff, and Patrick Pouzar, director of the investigations branch in the Nashville district office

Patrick J. Pouzar and John F. Harty Jr.

The year before, in March 1989, an individual telephoned the U.S. Embassy in Chile, on three separate occasions, warning that fruit being exported to the U.S. and Japan would be intentionally adulterated. Those calls prompted FDA to step up inspections of Chilean fruit entering the Port of Philadelphia, the entry point for 80 percent of all imported Chilean fruit in 1989. Since FDA investigators didn’t know what kind of fruit had been targeted or on which ship, they set up a sampling schedule to look for any irregularities. The first cargo to be inspected was from the Almeria Star, which was carrying some 364,000 boxes of fruit in her holds. Out of 12,000 representative boxes of fruit examined from that ship, inspectors found three punctured grapes at the top of one box. The crate was sent to an FDA lab, which identified trace amounts of cyanide in two of the damaged grapes.

Unfortunately, this was not the first case of product tampering for FDA. The agency had confronted cyanide in Tylenol capsules in 1982; pins, needles and other objects added to Girl Scout cookies in 1983; glass fragments found in Gerber fruit juice products in 1984; and poisoned unprocessed chocolate milk in 1986.

In a press release issued on March 13, 1989, FDA stated that it had “found and confirmed traces of cyanide in a small sample of seedless red grapes from Chile and, as a result, is detaining all grapes and other fruit from that country and is urging that they be withdrawn from the U.S. market.” In addition, it advised consumers to “check the source of any fresh, non-citrus fruit and not to eat any Chilean fruit" that they had on hand.

FDA then set about implementing a program of inspections and tests to return Chilean fruit to U.S. markets. Any Chilean fruit in the hands of importers, wholesalers and retailers already released to the U.S. market was to be destroyed. Fruit still in Chile was subjected to increased security, as well as inspections and lab tests. Finally, Chilean fruit at U.S. docks, or in transit to the U.S., received increased visual inspection, and all suspicious-looking fruit was subjected to laboratory testing. By the time this heightened inspection at U.S. ports of entry had ended in mid-April, FDA had “inspected and cleared” more than 9 million crates of Chilean fruit. No other tampered fruit was ever found related to this incident, but FDA’s decisive action emphasized the important role our import inspection plays in protecting the public from unsafe products that FDA regulates, including foods.

Mr. Harty, a 20-year veteran at FDA, served as the principal liaison between the Agency and Chile throughout this incident. He traveled to Chile in 1990 with Mr. Pouzar at the request of the Chilean government to review the steps that Chile had taken to ensure the safety of fruit products exported to the U.S. “Their mission was an important one,” recalled then Associate Commissioner for Regulatory Affairs Ronald Chesemore. “Not only did it illustrate our desire to cooperate fully with the Chilean government, it also allowed us to add another safety measure into our import review program to assure the quality of fruit products entering our country.”

Sadly, shortly after take-off from Copiapo Chamonate Airport, the small plane carrying Mr. Harty and Mr. Pouzar crashed. Three other people, an official from the Chilean Exports Association, a Chilean Exporters Association executive, and the pilot, also died in the incident. There were no survivors.

Mr. Harty was 48 at the time. Mr. Pouzar, another 20-year-plus veteran at FDA, was 49. To honor their sacrifice, both men were posthumously awarded the Secretary of Health and Human Service’s Recognition Award “for stalwart, stellar service to all of mankind.” As an enduring memory of the two men, two permanent memorials were established -- the John F. Harty, Jr. Memorial Library in the New England District Office where “Jack,” as he was called, started his FDA career and the Patrick J. Pouzar Investigator of the Year Award, presented annually to an FDA field investigator who has made “substantial contributions in protecting consumers and enhancing public health by maximizing compliance of FDA-regulated products and minimizing risk associated with those products.”

In 1992, about 2,500 Chilean fruit growers and exporters and several American importers filed a lawsuit in the U.S. District Court for the Eastern District of Pennsylvania against the federal government for $212 million, arguing that FDA’s lab results had been faulty. A year later, Judge Herbert J. Hutton ruled that FDA was not responsible for Chile’s financial losses. "The actions were clearly in furtherance of the F.D.A.'s statutory mission to protect the American public from adulterated food," he said.

These events underscore the critical role FDA plays in the lives of our fellow citizens - from assuring the safety and efficacy of the medical products patients depend on, to the safety of the food we feed our families. The portfolio of products FDA is responsible for accounts for 20 cents of every dollar spent by U.S. consumers. The breadth and impact of this portfolio is impressive, and the trust placed in FDA to fulfill our public health mission, humbling. Thirty years have passed since the tragic loss of our FDA colleagues, Mr. Harty and Mr. Pouzar; yet, the dedication and commitment to protecting the American people lives on, demonstrated in the daily actions of FDA officials in furtherance of our vital public health mission.

Anna Abram is FDA's Deputy Commissioner for Policy, Legislation, and International Affairs
Judith A. McMeekin is FDA's Acting Associate Commissioner for Regulatory Affairs
Vanessa Burrows is an FDA Historian