02.23.23

Durbin, DeLauro Continue To Urge FDA Commissioner Califf To Implement Reforms At The Agency’s Human Foods Program

While Califf announced FDA would implement some changes, the members continue to urge the agency to do more to prevent foodborne illnesses

WASHINGTON – U.S. Senate Majority Whip Dick Durbin (D-IL) and U.S. Representative Rosa DeLauro (D-CT) sent a follow-up letter to the Food and Drug Administration (FDA) Commissioner Dr. Robert Califf urging him to make critical reforms within FDA’s Human Foods Program.  Following the recent external evaluation and report by the Reagan-Udall Foundation, which outlined various flaws at FDA including their slow response to foodborne illness outbreaks, particularly with infant formula, and failure to properly implement the Food Safety Modernization Act (FSMA), Commissioner Califf stated FDA would make certain changes to address these issues.  

While Durbin and DeLauro applauded Califf’s previous statement, they once again urged him to do more to improve FDA’s responsiveness to foodborne illnesses.  The lawmakers cited specific examples on how to improve FDA, including by integrating the Office of Regulatory Affairs’ (ORA) food-related inspection responsibilities within FDA’s Human Foods Program.  Today’s letter follows a January 30th letter Durbin and DeLauro sent to FDA. 

“We are writing to follow up on our January 30, 2023, letter in which we called for specific reforms to be implemented at the Food and Drug Administration (FDA) to better ensure the safety of our nation’s food supply,” wrote Durbin and DeLauro.  “We were pleased to see your announcement last month that you would implement some of our recommendations, including the appointment of a Deputy Commissioner for Human Foods.  This is an important step, but we believe more can, and should be done.  Notably, we continue to encourage you to integrate the Office of Regulatory Affairs’ (ORA) food-related inspection responsibilities within the FDA’s Human Foods Program, as recommended by the Reagan-Udall Foundation’s report released in December 2022.”  

FSMA, which Durbin and DeLauro authored, required FDA to “increase the frequency of inspection[s]” at all food facilities.  The Congressional intent behind this legislation was clear, but ORA did not follow through.  In 2011, when FSMA was signed into law, ORA inspected 10,635 domestic food facilities.  A decade later, in 2021, only 4,535 domestic food facilities were inspected—nearly a 60 percent decrease, despite the fact that ORA received additional authorities and tools through FSMA.  In a 2017 report, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) found that ORA did not “always take action when it uncovered significant inspection violations.”  Even when ORA acted, the OIG found that it relied on “facilities to voluntarily correct the violations,” and did not “conduct timely follow-up inspections to ensure that facilities corrected significant inspection violations.” 

Durbin and DeLauro continued, “ORA’s work must be integrated within the Human Foods Program to ‘ensure that [the FDA’s] field work aligns with the foods program policies’ and to ‘facilitate the transformation of the inspectional service to the prevention model envisioned in [the] FSMA,’ according to the Reagan-Udall Foundation.  If we want to make real, tangible improvements to our nation’s food safety system, we must—at a minimum—find a way to increase and improve FDA’s facility inspection capabilities.  Given that ORA has demonstrated time and again it is not up to the task, change is needed.”

“We commend you for the initial steps you have taken to improve FDA’s food oversight program.  But additional, bold action is necessary, in line with the recommendations from the Reagan-Udall report,” the lawmakers concluded.

Every year, more than 48 million Americans are sickened, 128,000 are hospitalized, and 3,000 lose their lives because of some bacteria or virus in their food.  In 2011, FSMA was signed into law to transform the United States’ approach to foodborne illnesses.  FSMA requested FDA to be more proactive, not reactive, to foodborne illnesses to prevent outbreaks in the first place, and empowered FDA with new authorities, resources, and funding to accomplish this goal.  But, as outlined in the Reagan-Udall report, FDA has not made this shift, despite FSMA’s passage more than a decade ago.  The law further required FDA to promulgate several rules so that it would prevent rather than respond to foodborne outbreaks.  However, more than a handful of times, FDA has missed congressionally mandated deadlines to implement them.

In July, Durbin, DeLauro, and Senator Richard Blumenthal (D-CT) introduced the Food Safety Administration Act of 2022, legislation that would establish the Food Safety Administration, a single food safety agency responsible for ensuring the safety of our nation’s food supply.  This new agency would take over food safety responsibilities currently housed at FDA.  In the Reagan-Udall Foundation’s report, this proposal was included as their first option for structural reform at FDA.

Full text of today’s letter is available here and below:

February 23, 2023 

Dear Commissioner Califf:

 

            We are writing to follow up on our January 30, 2023, letter in which we called for specific reforms to be implemented at the Food and Drug Administration (FDA) to better ensure the safety of our nation’s food supply.  We were pleased to see your announcement last month that you would implement some of our recommendations, including the appointment of a Deputy Commissioner for Human Foods.  This is an important step, but we believe more can, and should be done.  Notably, we continue to encourage you to integrate the Office of Regulatory Affairs’ (ORA) food-related inspection responsibilities within the FDA’s Human Foods Program, as recommended by the Reagan-Udall Foundation’s report released in December 2022. 

            There are more than 81,000 domestic food facilities and 116,000 foreign food facilities registered with the FDA, which process most of the foods that Americans eat.  It is critical that ORA inspect these facilities.  But, for far too long, ORA has been asleep at the wheel. 

            The FDA Food Safety Modernization Act (FSMA) required FDA to “increase the frequency of inspection[s]” at all food facilities.  The Congressional intent behind this legislation was clear, but ORA did not follow through.  In 2011, when FSMA was signed into law, ORA inspected 10,635 domestic food facilities.  A decade later, in 2021, only 4,535 domestic food facilities were inspected—nearly a 60 percent decrease, despite the fact that ORA received additional authorities and tools through FSMA.   

Further, in a 2017 report, the Department of Health and Human Services Office of Inspector General (OIG) found that, in the rare instance that an inspection was conducted, ORA did not “always take action when it uncovered significant inspection violations.”  Even when ORA acted, the OIG found that it relied on “facilities to voluntarily correct the violations,” and did not “conduct timely follow-up inspections to ensure that facilities corrected significant inspection violations.”  This is unacceptable.  

            Your decision to allow ORA to maintain its food-related inspection responsibilities—despite its apparent inability to effectively carry out its regulatory duties—could result in the same dismal oversight and enforcement that Americans have been forced to live with over and over again.  

Please reconsider this decision.  ORA’s work must be integrated within the Human Foods Program to “ensure that [the FDA’s] field work aligns with the foods program policies” and to “facilitate the transformation of the inspectional service to the prevention model envisioned in [the] FSMA,” according to the Reagan-Udall Foundation.  If we want to make real, tangible improvements to our nation’s food safety system, we must—at a minimum—find a way to increase and improve FDA’s facility inspection capabilities.  Given that ORA has demonstrated time and again it is not up to the task, change is needed.

We commend you for the initial steps you have taken to improve FDA’s food oversight program.  But additional, bold action is necessary, in line with the recommendations from the Reagan-Udall report.  We look forward to hearing back from you on this important matter. 

Sincerely, 

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