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Oversight on Outbreak re: Government Accountability Office Responses

GAO report critical of USDA’s response to disease outbreaks:

  • USDA has the authority to implement response measures to animal disease outbreaks to limit economic, animal health, and food security consequences. On January 14, 2016, the Government Accountability Office (GAO), the independent investigative arm of Congress, publically released a report critical of the USDA’s response to outbreaks of emerging animal diseases.  GAO studied USDA’s response to two highly contagious diseases, referred to collectively as Swine Enteric Coronavirus Diseases (SECD), that caused the deaths of millions of pigs in the U.S. in 2013 and 2014.  GAO concluded that, although USDA took steps to improve its response following the 2013 outbreak, the Agency needs to implement additional measures to better prepare for emerging animal disease outbreaks.

  • When SECD were first identified in the U.S. in May 2013, USDA did not take regulatory action based, in part, on the fact that SECD is not known to pose a risk to any species other than swine, the disease is not lethal to all pigs, and a quarantine would have resulted in the euthanasia of large numbers of animals – because swine are often moved among different premises to accommodate their growth, many facilities are unable to humanely house pigs larger than they customarily handle.  GAO concluded that USDA’s failure to take swift regulatory action limited the Agency’s understanding of and ability to respond to the outbreak.

  • In 2014, USDA issued a federal order imposing reporting and planning requirements and provided financial assistance to states and producers.  The Agency also released draft guidance and a proposed list of animal diseases that must be reported by anyone with knowledge of the diseases.  While the GAO report praised these efforts, the report notes that USDA still needs to define and communicate key aspects of its approach for responding to emerging animal diseases, including when the agency will take a lead role, what the agency’s responsibilities will be, and examples of circumstances that may trigger actions such as euthanasia or quarantines.  USDA indicated that it intends to refine and expand the draft guidance to clarify these matters.  As is the case for food borne illness, USDA must engage in a difficult balancing act when determining how to respond to animal disease outbreaks – if the Agency implements restrictive measures to contain an outbreak before all facts are known, it may impose needless costs if the outbreak is later discovered to be low risk, but if the Agency waits to act until more is known, it may be giving a virulent, lethal disease time to spread.

© 2020 Keller and Heckman LLPNational Law Review, Volume VI, Number 15
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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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