Food Safety

House Bill Calls for Single Food Safety Entity Under FDA


by Keith Loria

A new bill, introduced by Rep. Rosa DeLauro (D-Conn.) and Sen. Dick Durbin (D-Ill.), looks to create a single food safety agency under the department of Health and Human Services that would be responsible for keeping all food safe for market. The legislation, known as the Food Safety Administration Act, would ensure that a single, full-time, fully empowered expert leader oversees all aspects of FDA’s food program.

“Food safety is currently a second-class citizen at the FDA,” Rep. DeLauro says. “Right now, there are no food policy experts in charge of food safety at the FDA. That is unacceptable and contributes to a string of product contaminations and subsequent recalls that disrupt the supply chain, contribute to rising prices and, in many cases, result in consumer illness and death.”

Mitzi Baum, CEO of STOP Foodborne Illness, notes that in recent history, FDA has had seven commissioners, all of whom were medical professionals. “Naturally, their focus has been medical products; thus, the food program has not received the attention or leadership it requires,” she tells Food Quality & Safety. “As the focal point has been on drug and medical devices, which receive disproportionately more funding, it has become abundantly clear the food program needs to stand alone to remain focused on the ever-evolving food system, food safety, and its impact on public health.”

Baum notes that appointing a food safety expert in a leadership role to direct the entirety of the Food Safety Administration would provide accountability across the programs, deliver coordinated responses to crises, improve communication, accelerate decision-making processes, and create a new culture of food safety across the agency. “The benefits are wide ranging but, most importantly, the impact would be on public health,” she adds.

Thomas Gremillion, director of food policy for the Consumer Federation of America, says that the legislation would bring much-needed attention and resources to overseeing the 80% of the food supply currently under FDA’s jurisdiction. “More and more in recent years, FDA’s drug and medical device programs have come to overshadow food,” he tells FQ&S. “By moving the FDA food program units—the Center for Food Safety and Applied Nutrition (CFSAN), Center for Veterinary Medicine (CVM), and the Office of Regulatory Affairs (ORA)—under one roof, the Food Safety Administration administrator will be able to better manage resources and be held accountable to Congress.”

Additionally, the bill would also set mandatory inspection frequencies for certain high-risk facilities and, in particular, require inspections of infant formula manufacturers every six months, which will help to avoid a replay of the problems at Abbott Labs Sturgis facility.

FDA Announces Review of Foods Program

On July 19, FDA announced that the agency will conduct an independent evaluation of its Human Foods Program, including the Office of Food Response and Policy (OFPR), CFSAN, as well as relevant parts of the ORA.

“While America’s food supply is safe … the program has been stressed by the increasing diversity and complexity of the nation’s food systems and supply chain,” said Robert M. Califf, MD, FDA’s commissioner, in a statement. “Fundamental questions about the structure, function, funding, and leadership need to be addressed.”

A report on the review’s findings will be issued within 60 days.

Reprinted from Food Quality & Safety Magazine, August 2, 2022

“House Bill Calls for Single Food Safety Entity Under FDA – by Keith Loria

食品安全性を管轄する統一的な当局を創設するための法案が米国議会に提出されました。Rosa DeLauro下院議員(民主党・コネチカット州選出)とDick Durbin上院議員(民主党・イリノイ州選出)が発議したもので、市場で販売されるすべての食品の安全性を一手に所轄する機関を保健福祉省の下に設置しようとする内容です。「食品安全性管理法(Food Safety Administration Act)」と呼ばれていて、必要な権限を完全に与えられたフルタイムの専門的な指導者によって食品医薬品局(FDA)のすべての食品制度を監督することを目指しています。


非営利団体のSTOP Foodborne IllnessのMitzi Baum代表は、ここしばらくの間にFDAの長官を務めた7人はすべて医療の専門家だったと指摘しています。「当然ながら、歴代長官の関心は医療製品に向けられており、食品制度はあまり注目されず、必要な指導力もないままだった」と『Food Quality & Safety』誌の取材で語っています。「FDAの重点は医薬品と医療機器にあり、予算もはるかに多く割かれている。食品制度を独立させて、刻々と変化する食品供給体制、食品安全性、それが公衆衛生に及ぼす影響を見つめ続ける必要があることが明らかになってきた」。


現時点でFDAは食品供給の80%を監督していますが、この事業が真に必要としてきたリソースと注目を今回の法案がもたらすと、非営利団体のConsumer Federation of Americaで食品政策責任者を努めるThomas Gremillion氏は考えています。「FDAでは近年ますます医薬品と医療機器の制度が食品制度を脇へと押しやるようになってきた」と『Food Quality & Safety』誌の取材で語っています。「FDAの食品担当部局である食品安全・応用栄養センター(CFSAN)、獣医薬品センター(CVM)、規制問題局(ORA)をひとつ屋根の下に移すことで、食品安全性局の長官がリソースをより良く管理し、議会に対する説明責任を負うようになる」。




「米国の食品供給は安全だが、(中略)国の食品供給体制とサプライチェーンが多様化・複雑化するなかで、制度に圧力がかかっている」とFDA長官のRobert M. Califf医師は発表声明で語っています。「構造、機能、予算、指導力に関する根本的な質問に対応しなければならない」。


Food Quality & Safety』誌、202282日号より転載

House Bill Calls for Single Food Safety Entity Under FDA(米国議会に提出された食品安全性の機関創設をめぐる法案)、著:Keith Loria

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