U.S. GOVERNMENT PUBLISHING OFFICE

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SAFETY OF THE U.S. FOOD SUPPLY: CONTINUING 

CONCERNS OVER THE FOOD AND DRUG ADMINISTRATION’S FOOD-RECALL PROCESS 

HEARING 

BEFORE THE

SUBCOMMITTEE ON OVERSIGHT AND 

INVESTIGATIONS 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED FIFTEENTH CONGRESS 

SECOND SESSION 

JANUARY 19, 2018 

Serial No. 115–93 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

GREG WALDEN, Oregon 

Chairman 

JOE BARTON, Texas 

Vice Chairman 

FRED UPTON, Michigan 

JOHN SHIMKUS, Illinois 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

LARRY BUCSHON, Indiana 

BILL FLORES, Texas 

SUSAN W. BROOKS, Indiana 

MARKWAYNE MULLIN, Oklahoma 

RICHARD HUDSON, North Carolina 

CHRIS COLLINS, New York 

KEVIN CRAMER, North Dakota 

TIM WALBERG, Michigan 

MIMI WALTERS, California 

RYAN A. COSTELLO, Pennsylvania 

EARL L. ‘‘BUDDY’’ CARTER, Georgia 

JEFF DUNCAN, South Carolina 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

DORIS O. MATSUI, California 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

PETER WELCH, Vermont 

BEN RAY LUJA ́ N, New Mexico 

PAUL TONKO, New York 

YVETTE D. CLARKE, New York 

DAVID LOEBSACK, Iowa 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California 

RAUL RUIZ, California 

SCOTT H. PETERS, California 

DEBBIE DINGELL, Michigan 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

GREGG HARPER, Mississippi 

Chairman 

H. MORGAN GRIFFITH, Virginia 

Vice Chairman 

JOE BARTON, Texas 

MICHAEL C. BURGESS, Texas 

SUSAN W. BROOKS, Indiana 

CHRIS COLLINS, New York 

TIM WALBERG, Michigan 

MIMI WALTERS, California 

RYAN A. COSTELLO, Pennsylvania 

EARL L. ‘‘BUDDY’’ CARTER, Georgia 

GREG WALDEN, Oregon (ex officio) 

DIANA DEGETTE, Colorado 

Ranking Member 

JANICE D. SCHAKOWSKY, Illinois 

KATHY CASTOR, Florida 

PAUL TONKO, New York 

YVETTE D. CLARKE, New York 

RAUL RUIZ, California 

SCOTT H. PETERS, California 

FRANK PALLONE, JR., New Jersey (ex 

officio) 

(II) 

(III) 

C O N T E N T S 

Page 

Hon. Gregg Harper, a Representative in Congress from the State of Mississippi, opening statement ................................................................................. 1 

Prepared statement .......................................................................................... 3 

Hon. Diana DeGette, a Representative in Congress from the State of Colorado, opening statement ...................................................................................... 4 

Hon. Greg Walden, a Representative in Congress from the State of Oregon, 

opening statement ................................................................................................ 6 

Prepared statement .......................................................................................... 7 

Hon. Frank Pallone, Jr., a Representative in Congress from the State of 

New Jersey, opening statement .......................................................................... 8 

Prepared statement .......................................................................................... 9 

Hon. Michael C. Burgess, a Representative in Congress from the State of 

Texas, prepared statement .................................................................................. 49 

WITNESSES

Gloria L. Jarman, Deputy Inspector General for Audit Services, Office of 

Inspector General, Department of Health and Human Services ..................... 11 

Prepared statement .......................................................................................... 13 

Answers to submitted questions ......................................................................

Douglas W. Stearn, Acting Deputy Director for Regulatory Affairs, Center 

for Food Safety and Applied Nutrition, and Director, Office of Enforcement 

and Import Operations, Office of Regulatory Affairs, Food and Drug Administration, Department of Health and Human Services ..................................... 23 

Prepared statement .......................................................................................... 25 

Answers to submitted questions 1 ................................................................... 62 

SUBMITTED MATERIAL

Subcommittee memorandum .................................................................................. 50 

1Mr. Stearn did not answer submitted questions for the record by the time 

of printing. 

(1) 

SAFETY OF THE U.S. FOOD SUPPLY: CONTINUING CONCERNS OVER THE FOOD AND 

DRUG ADMINISTRATION’S FOOD-RECALL 

PROCESS 

FRIDAY, JANUARY 19, 2018 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, 

COMMITTEE ON ENERGY AND COMMERCE, 

Washington, DC. 

The subcommittee met, pursuant to call, at 10:00 a.m., in room 

2123, Rayburn House Office Building, Hon. Gregg Harper (chairman of the subcommittee) presiding. 

Members present: Representatives Harper, Griffith, Brooks, Collins, Walberg, Costello, Carter, Walden (ex officio), DeGette, Schakowsky, Castor, Tonko, and Pallone (ex officio). 

Staff present: Jennifer Barblan, Chief Counsel, Oversight and Investigations; Ray Baum, Staff Director; Jordan Davis, Director of 

Policy and External Affairs; Ali Fulling Legislative Clerk, Oversight and Investigations, Digital Commerce and Consumer Protection; Brittany Havens, Professional Staff Member, Oversight and 

Investigations; Jennifer Sherman, Press Secretary; Alan Slobodin, 

Chief Investigative Counsel, Oversight and Investigations; Jacquelyn Bolen, Minority Professional Staff Member; Evan Gilbert, 

Minority Press Assistant; Christopher Knauer, Minority Oversight 

Staff Director; Miles Lichtman, Minority Policy Analyst; Kevin 

McAloon, Minority Professional Staff Member; Tim Robinson, Minority Chief Counsel; and Andrew Souvall, Minority Director of 

Communications, Member Services, and Outreach. 

OPENING STATEMENT OF HON. GREGG HARPER, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MISSISSIPPI 

Mr. HARPER. The subcommittee convenes this hearing entitled 

‘‘Safety of the U.S. Food Supply: Continuing Concerns Over the 

Food and Drug Administration’s Food-Recall Process.’’ Disease outbreaks from tainted food are an ongoing public health challenge. 

The Centers for Disease Control estimates that each year, one in 

six Americans, 48 million people, get sick from foodborne illnesses, 

128,000 are hospitalized, and 3,000 die. 

The number of multistate food illness outbreaks is increasing, affecting greater numbers of Americans. And the number of vulnerable people, older and immune-compromised individuals, is growing. The threat of foodborne illness persists even though we have 

2 

gotten better at detecting and investigating outbreaks. And 

through the implementation of the Hazard Analysis and Critical 

Control Point rules over the last two decades, CDC trend data indicates major reductions in the incidents of foodborne disease. Yet 

the problem remains significant. 

When contaminated food reaches store shelves, the FDA is a 

public’s last line of defense. The FDA needs to be able to quickly 

and effectively help remove dangerous foods from commerce and 

protect consumers. In 2010, Congress gave FDA more power to recall tainted food. The FDA Food Safety Modernization Act, FSMA, 

was enacted to provide FDA with the authority to mandate a food 

recall. 

In addition to this law, previous audits by both the HHS, Office 

of Inspector General, and the Government Accountability Office 

made recommendations to FDA to improve its food-recall program. 

How has FDA performed with food recalls in recent years with the 

new law and these recommendations? Over the last 2 years, the 

HHS OIG looked at this question, and last month released a report 

that contains findings and recommendations for FDA. 

The OIG report looked at 30 voluntary food recalls overseen by 

FDA between October of 2012 and May of 2015. The FDA has used 

its mandatory recall authority only two times since the enactment 

of FSMA, and not at all over the last 4 years. In some cases, the 

FDA was slow to evaluate health hazards. It took FDA an average 

of 47 days to complete an evaluation after learning of a planned 

or in-progress food recall. 

The OIG found that FDA was woefully slow in starting recalls. 

The average length before a recall began, once FDA knew of the 

safety issue, was 57 days. The report also raises questions about 

the FDA’s ability to cope with uncooperative companies. 

In one case involving a dietary supplement company, it took 10 

months after FDA issued a warning letter about unlisted ingredients before the firm finally pulled the product. In another case, a 

recall of nut butter began more than 5 months after the FDA had 

traced the Salmonella outbreak to the source facility. There were 

14 illnesses in 11 States during that time. 

A series of recalls of cheese products contaminated with Listeria 

took 81 days to complete, nine people got sick, including one infant 

who died, and two fetal losses linked to illness. During that time, 

the firm owner lied to the FDA, saying that the firm would suspend the manufacturing and distribution of cheese. However, the 

owner, despite knowing that the product tested positive for Listeria, continued to allow the product to be distributed. The owner 

later pleaded guilty to FDA crimes and went to prison. Justice was 

done, but FDA needed to find a way to detect such deception sooner. 

The OIG also found that FDA did not have a reliable system for 

accessing the recall initiation date, or the date FDA became aware 

of potentially hazardous food products. More than a third of the recalls reviewed had the wrong initiation date entered into FDA’s 

electronic data system, called the Recall Enterprise System. 

The electronic data system also did not include when FDA first 

found out about the suspect food products. Worse, FDA does not 

collect sufficient or accurate data so that the agency can measure 

3 

its performance to tell whether their food-recall performance is improving. 

In addition to the OIG findings, the FDA told committee staff in 

a briefing that there are concerns about the turn-around time it 

takes to get test results from FDA labs that are used to make an 

evaluation of the seriousness of the food hazard. 

To ensure the FDA labs are performing properly, FDA needs to 

provide independent funding and permanent staff to its Office of 

Laboratory Science and Safety. This office has not been fully stood 

up and has been unable to inspect FDA labs. FDA should follow 

the example of the CDC. The CDC’s Office of Lab Science and Safety has dedicated funding and permanent staff to oversee CDC’s 

own labs. 

The enactment of FSMA provided FDA mandatory recall authority and imposed more legal obligations on food manufacturers and 

distributors. FDA has the tools, but the OIG’s findings and FDA’s 

own assessments, show that the FDA needs to reform itself to get 

this right. I’m heartened that the FDA commissioner has recognized that even just a handful of problematic recalls are too many, 

because lives are at stake. 

I’m also glad that the Commissioner has announced that FDA is 

looking at ways to improve the timeliness and scope of information 

provided to the public about FDA-regulated food recalls. 

I welcome and thank the witnesses and look forward to their testimony. 

[The prepared statement of Mr. Harper follows:] 

PREPARED STATEMENT OF HON. GREGG HARPER

The subcommittee convenes this hearing entitled ‘‘Safety of the U.S. Food Supply: 

Continuing Concerns Over the Food and Drug Administration’s Food-Recall Process.’’ 

Disease outbreaks from tainted food are an ongoing public health challenge. The 

Centers for Disease Control (CDC) estimates that each year one in six Americans— 

48 million people—get sick from foodborne illness, 128,000 are hospitalized, and 

3,000 die. The number of multistate food illness outbreaks is increasing, affecting 

greater numbers of Americans. And the number of vulnerable people, older and immune-compromised individuals, is growing. 

The threat of foodborne illness persists, even though we have gotten better at detecting and investigating outbreaks. And through the implementation of the Hazard 

Analysis and Critical Control Point (HACCP) rules over the last two decades, CDC 

trend data indicates major reductions in the incidence of foodborne disease. Yet the 

problem remains significant. 

When contaminated food reaches store shelves, the FDA is the public’s last line 

of defense. The FDA needs to be able to quickly and effectively help remove dangerous foods from commerce and protect consumers. In 2010, Congress gave FDA 

more power to recall tainted food. The FDA Food Safety Modernization Act (FSMA) 

was enacted to provide FDA with the authority to mandate a food recall. In addition 

to this law, previous audits by both the HHS Office of Inspector General (OIG) and 

the Government Accountability Office (GAO) made recommendations to FDA to improve its food-recall program. 

How has FDA performed with food recalls in recent years with the new law and 

these recommendations? Over the last 2 years, the HHS OIG looked at this question 

and last month released a report that contains findings and recommendations for 

FDA. 

The OIG report looked at 30 voluntary food recalls overseen by FDA between October 2012 and May 2015. The FDA has used its mandatory recall authority only 

two times since the enactment of FSMA and not at all over the last 4 years. In some 

cases, the FDA was slow to evaluate health hazards. It took FDA an average of 47 

days to complete an evaluation after learning of a planned or in-progress food recall. 

4 

The OIG found that FDA was woefully slow in starting recalls. The average 

length before a recall began once FDA knew of the safety issue was 57 days. 

The report also raises questions about the FDA’s ability to cope with uncooperative companies. In one case involving a dietary supplement company, it took 10 

months after FDA issued a warning letter about unlisted ingredients before the firm 

finally pulled the product. In another case, a recall of nut butter began more than 

5 months after the FDA had traced the Salmonella outbreak to the source facility. 

There were 14 illnesses in 11 States during that time. 

A series of recalls of cheese products contaminated with Listeria took 81 days to 

complete. Nine people got sick, including one infant who died and two fetal losses 

linked to illness. During that time, the firm owner lied to the FDA, saying that the 

firm would suspend the manufacturing and distribution of cheese. However, the 

owner, despite knowing that the product tested positive for Listeria, continued to 

allow the product to be distributed. The owner later pleaded guilty to FDA crimes 

and went to prison. Justice was done, but FDA needed to find a way to detect such 

deception sooner. 

The OIG also found that FDA did not have a reliable system for accessing the 

recall initiation date or the date FDA became aware of potentially hazardous food 

products. More than a third of the recalls reviewed had the wrong initiation date 

entered into FDA’s electronic data system, called the Recall Enterprise System 

(RES). The electronic data system also did not include when FDA first found out 

about the suspect food products. Worse, FDA does not collect sufficient or accurate 

data so that the agency can measure its performance to tell whether their food-recall performance is improving. 

In addition to the OIG findings, FDA told committee staff in a briefing that there 

are concerns about the turnaround time it takes to get test results from FDA labs 

that are used to make an evaluation of the seriousness of the food hazard. To ensure 

the FDA labs are performing properly, FDA needs to provide independent funding 

and permanent staff to its Office of Laboratory Science and Safety. This office has 

not been fully stood up and has been unable to inspect FDA labs. FDA should follow 

the example of the CDC. The CDC’s Office of Lab Science and Safety has dedicated 

funding and permanent staff to overseeing CDC’s own labs. 

The enactment of the FSMA provided FDA mandatory recall authority and imposed more legal obligations on food manufacturers and distributors. FDA has the 

tools, but the OIG’s findings and FDA’s own assessments show that the FDA needs 

to reform itself to get this right. 

I am heartened that the FDA Commissioner has recognized that even just a handful of problematic recalls are too many, because lives are at stake. I am also glad 

that the Commissioner has announced that FDA is looking at ways to improve the 

timeliness and scope of information provided to the public about FDA-regulated 

food-recalls. 

I welcome and thank the witnesses, and look forward to their testimony. 

Mr. HARPER. I’ll now recognize the ranking member, Ms. 

DeGette, for the purpose of her opening statement. 

OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF COLORADO 

Ms. DEGETTE. Thank you so much, Mr. Chairman. As you know, 

food safety is not a new issue for this committee. Many of the challenges that we’re going to hear about today are the same issues 

that we’ve dealt with over the past decade. All of those examples 

you mentioned were brought up in hearings in front of this committee. 

For example, we held a hearing in 2008 on a major Salmonella 

outbreak that infected over 1,300 people in 43 States. As that case 

illustrated, we lacked basic controls over food recalls, including 

traceability. FDA and CDC originally identified tomatoes as the 

likely cause of the outbreak, but later on they found out it was because of jalapenos. 

Now, this was frustrating to all of us because lives were at stake. 

The Federal response was slow and inefficient, and yet that case 

5 

demonstrated that the response is not as simple as just pulling off 

all the suspected products from the shelves, because an entire industry should be devastated. 

When we had these hearings where we thought it was the tomatoes, the tomato industry was absolutely devastated at that time, 

and it turned out that the problem wasn’t even tomatoes, but 

jalapenos. So it was clear then, as it is now, that the FDA needs 

the ability to respond to a multitude of different situations that 

pose risks to the public health. 

As you noted, Mr. Chairman, in response to incidents like that, 

we passed the FDA Food Safety Modernization Act in 2011, and 

many of the Members on this committee worked in a bipartisan 

way on that bill. It gave the FDA more tools to prevent and to respond to outbreaks, including, critically, new authority to issue 

mandatory recall orders and requirements for manufacturing firms 

to have recall plans in place. 

But now, 7 years after we pass the law, the Office of Inspector 

General has a new report that points to some of the same issues 

that we’ve been worrying about in this committee for years. Despite 

the progress that we’ve made, here we find ourselves. 

OIG found that, despite more power to oversee manufacturing 

firms that produce potentially hazardous food, FDA is not doing 

enough to monitor firms during a recall. Sometimes there have 

been long delays in getting firms to recall all of their affected product, or even to provide the FDA with basic information. 

In addition to insufficient oversight of firms, FDA has also weaknesses in its own recall responses. For example, it’s critical for the 

public to understand the risk that a food product may present. But 

OIG found that FDA was sometimes slow to evaluate the health 

hazard posed by a contaminated product. 

This is not to say that these cases are easy and the answer’s always crystal clear. The FDA is dealing with many recalls every 

year, each of which presents its own challenges and complexities. 

That being said, I do think there’s more the FDA can do to improve 

the food safety system. 

OIG’s report presents multiple recommendations for FDA, such 

as improving its policies and procedures for managing recalls and 

monitoring firms. However, I’d like to hear more from OIG about 

what specific meaningful steps it thinks FDA should take. A few 

more procedure documents and guidance manuals are not enough. 

We need to know what actually needs to change to help better protect the American public. 

As FDA continues to implement provisions of FSMA, the committee needs to hear how the law is working, what more the FDA 

needs to do, and how Congress can help. I’d like to take a moment 

of personal privilege, if I may. I just saw the former chairman of 

the committee walk into the room, Bart Stupak, and Congressman 

Stupak was one of the key players in enactment of this food safety 

legislation. Welcome. We’re glad to have here you. I’m sorry that 

we’re still talking about this 7 years later. 

With that, Mr. Chairman, I yield back. 

Mr. HARPER. The gentlelady yields back. And I would also like 

to welcome Mr. Stupak for his attendance today. It’s great to see 

you back, and wish you the best. Now the Chair would recognize 

6 

the chairman of the full committee, Mr. Walden, for the purpose of 

an opening statement. 

OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF OREGON 

Mr. WALDEN. Thank you, Mr. Chairman. And, Bart, good to see 

you again. I enjoyed serving with you when we did all that oversight work, and it’s good to see you here. 

You know, I take this issue very personally. In February of 2009, 

this subcommittee held hearings on nationwide outbreaks of Salmonella-related illnesses linked to products from the Peanut Corporation of America. One of the witnesses at that hearing was 

Peter Hurley from Wilsonville, Oregon. 

When Peter’s then 3-year-old son, Jake, became sick, doctors recommended they give him his favorite food just to encourage him to 

eat. Well, Jake’s favorite food was Austin brand peanut butter 

crackers. Tragically, that turned out to be the very thing that was 

poisoning him. When Oregon State officials tested the crackers, 

three of the six packages contained peanut butter contaminated by 

Salmonella. 

Jake became ill because Stewart Parnell, the CEO of PCA, knew 

that the peanut products were contaminated with Salmonella when 

he told the plant manufacturer to, quote, ‘‘turn them loose.’’ At that 

same hearing, I confronted Mr. Parnell with this container, and I 

asked him whether he was willing to take the lid off and eat any 

of these products now, since he was so cavalier about turning it 

loose on little kids like Jake to eat. He refused, of course, citing his 

5th Amendment rights. 

Thankfully, Jake overcame his illness, and it was great to see 

him last year. He’s now a young teenager. He and his dad came 

back to visit us. More than 600 people in 44 States were sickened. 

And, unlike Jake, nine people died. As a result, Mr. Parnell is currently serving a 28-year sentence in prison for his actions. 

Now, while this case of PCA is the exception and not the rule, 

fortunately, foodborne illnesses remain a major concern. Chairman 

Harper just ran through those numbers. Each year, 48 million people are sick and 3,000 die from foodborne illnesses. Federal oversight of food safety has been on the Government Accountability Office’s high-risk list since 2007. 

And just in the past few months, dozens of people in the United 

States and Canada were infected and two have died from what appears to be an E. coli contamination related to leafy greens. So 

we’re here today to check in on the Food and Drug Administration 

and their work to protect the Nation’s food supply chain and ensure health and safety for all Americans. 

I was glad to see the FDA Commissioner, Scott Gottlieb, showed 

his commitment to improving food safety in our Nation with yesterday’s announcement that the FDA will accelerate the release of information about problematic products before they may officially be 

classified as recall items. We look forward to hearing from the FDA 

today about what plans and benchmarks it’s developed to fully implement the law and address the recommendations from the OIG. 

We also look forward to the FDA implementing the other expert 

recommendations to provide proper funding and permanent staff to 

7 

the FDA office that oversees the FDA labs, which do play a critical 

role in food recalls. 

I thank the HHS OIG for testifying today and commend its work 

with both the recent report in December as well as the Early Alert 

it issued to FDA in June of 2016. This recent work builds on the 

past work done by the OIG, most notably two reports related to 

food recalls that were released in 2009 and 2011. 

While the reports from 2009 and 2011 were issued prior to the 

Food Safety Modernization Act, many of the recommendations in 

the recent December report are similar, if not the same as they 

were in 2009 and 2011. 

Further, the GAO raised concerns about FDA’s food-recall process in 2012. And while FDA says that it’s addressed many of the 

findings of the recent OIG report, it is troubling that many of the 

recommendations from almost a decade ago stand today, despite 

the additional authority given to the FDA through FSMA in 2010. 

Today’s hearing will give us a good opportunity for FDA to share 

specific plans to address the recommendations made by the OIG, 

including the timeframe in which we can expect these changes to 

be implemented. I don’t see Dr. Burgess, I know he was looking for 

some time. If anyone else would like the remainder of my time— 

if not, I will yield back to the chairman so we can proceed with the 

hearing. 

And I also have another hearing I have to go to, so I’ll be in and 

out of this one. Thank you again for the good work you do. I know 

we’re on the same team to try to and make sure Americans can 

trust their food is safe to eat. With that, I yield back. 

[The prepared statement of Mr. Walden follows:] 

PREPARED STATEMENT OF HON. GREG WALDEN

Thank you, Mr. Chairman, for holding this important hearing. 

I take this issue very personally. In February 2009, this subcommittee held a 

hearing on the nationwide outbreak of Salmonella-related illnesses linked to products from the Peanut Corporation of America (PCA). One of the witnesses at that 

hearing was Peter Hurley, from Wilsonville, Oregon. When Peter’s then 3-year-old 

son, Jake, became sick, doctors recommended that they give him his favorite foods 

to encourage him to eat. Well, Jake’s favorite food was Austin brand peanut butter 

crackers—which turned out to be the very thing that was poisoning him. When Oregon State officials tested the crackers, three of the six packages contained peanut 

butter contaminated by Salmonella. 

Jake became ill because Stewart Parnell, the CEO of PCA, knew that the peanut 

products were contaminated with Salmonella when he told the plant manager to 

‘‘Turn them loose.’’ At that same hearing, I confronted Mr. Parnell with this container of products. I asked him whether he would be willing to take the lid off and 

eat any of these products now, since he was so cavalier about turning it loose on 

little kids like Jake. He declined to answer, citing the Fifth Amendment. 

Thankfully, Jake overcame his illness, and it was great to see him, now a young 

teenager, and his dad during a visit to DC last year. More than 600 other people 

in 44 States were sickened. Nine people died. As a result, Mr. Parnell is currently 

serving a 28-year sentence for his action. 

While the case of PCA is the exception, and not the rule, foodborne illness remains a major concern. Chairman Harper just ran through the numbers—each year 

48 million people become sick and 3,000 die from foodborne diseases. Federal oversight of food safety has been on the Government Accountability Office’s high-risk list 

since 2007. 

And just in the past few months, dozens of people in the United States and Canada have been infected and two have died from what appears to be E. coli-contaminated leafy greens. We are here today to check in on the Food and Drug AdministraVerDate Mar 15 2010 11:46 Jan 08, 2019 Jkt 037690 PO 00000 Frm 00011 Fmt 6633 Sfmt 6633 I:\115THCONGRESS\115X93FDARECALLSAWAITSTEARNQFRR\115X93FDARECALLSPD
8 

tion (FDA) and their work to protect the Nation’s food supply chain and ensure the 

health and safety of Americans. 

I was glad to see that FDA Commissioner Gottlieb showed his commitment to improving food safety in our Nation with yesterday’s announcement that the FDA will 

accelerate the release of information about problematic products before they may officially be classified as recalled items. We look forward to hearing from FDA today 

about what plans and benchmarks it has developed to fully implement the law and 

address the recommendations from the OIG. We also look forward to FDA implementing other expert recommendations to provide proper funding and permanent 

staff to the FDA office that oversees the FDA labs, which play a critical role in food 

recalls. 

I thank the HHS OIG for testifying today and commend its work with both the 

recent report in December, as well as the Early Alert it issued to FDA in June 2016. 

This recent work builds on past work done by the OIG, most notably two reports 

related to food recalls that were released in 2009 and 2011. 

While the reports from 2009 and 2011 were issued prior to the Food Safety Modernization Act (FSMA), many of the recommendations in the recent December report 

are similar, if not the same, as they were in the 2009 and 2011 reports. Further, 

the GAO also raised concerns about FDA’s food-recall process in 2012. While FDA 

says that it has addressed many of the findings in the recent OIG report, it is troubling that many of the recommendations from almost a decade ago stand today despite the additional authority given to the FDA through FSMA in 2010. 

Today’s hearing will be a great opportunity for FDA to share specific plans to address the recommendations made by the OIG, including the timeframe in which we 

can expect these changes to be implemented. 

I welcome our witnesses and look forward to their testimony. 

Mr. HARPER. Thank you, Mr. Chairman. Now the Chair will recognize the ranking member of the full committee, Mr. Pallone, for 

purposes of an opening statement. 

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY 

Mr. PALLONE. Thank you, Mr. Chairman. This committee has a 

long history of overseeing food safety. Over the last decade, we’ve 

had multiple hearings examining the Food and Drug Administration’s oversight of food recalls and the agency’s authority to protect 

the Nation’s food supply. 

FDA plays a critical role. In fiscal year 2017 alone, FDA oversaw 

more than 3,600 recalls, and this is no small task, but we have 

seen cases that exposed weaknesses in FDA’s ability to respond to 

these threats. For example, as already mentioned, in 2007 a committee investigation into a Salmonella outbreak identified serious 

flaws in our food safety network. 

In 2010, the committee found that FDA had limited authority to 

ensure compliance and did not always take swift action when needed. Witnesses repeatedly told this committed that FDA lacked sufficient authority to address weaknesses in our food safety system, 

and that’s why Congress passed the FDA Food Safety Modernization Act, or FSMA, in 2011, and FSMA significantly reformed 

FDA’s overall approach to food safety and gave FDA new authorities to strengthen the food-recall process. 

For instance, FDA now has the ability to mandate recall when 

a product poses a serious adverse health consequence. This is a significant tool because we’ve seen cases of manufacturing firms reluctant to cooperate with the FDA. And thanks to FSMA, firms are 

also now required to have recall plans in place to help prepare before contamination occurs. 

9 

FSMA provided these new tools, but it’s up to FDA to make sure 

they are being put to good use, and that’s why this hearing is so 

important. We need to hear about how FDA is implementing 

FSMA, and whether things have improved since we passed the law. 

A recent Office of Inspector General report shed some light on that 

question and suggests that FDA still may not always adequately 

oversee food recalls. 

The Inspector General reported that FDA did not always effectively monitor firms during a recall, such as ensuring that firms 

initiate the recalls promptly. And some of the cases highlighted in 

the report are particularly troubling. For example, between 2012 

and 2014, as was mentioned, nut butter contaminated with Salmonella sickened 14 people in 11 States. FDA identified the source 

of the outbreak in March of 2014, but the products were not fully 

recalled until August of that year, 165 days later. 

The Inspector General also cited a series of recalls of cheese 

products that were contaminated with Listeria and led to one infant’s death and two lost pregnancies. And I know everyone on this 

committee will argue that even one fatality is far too many. So, 

while we should recognize that these issues are complex and every 

recall poses a unique challenge, these findings demonstrate that 

FDA must exercise judicious yet forceful oversight when the 

public’s health is at risk. 

And so I look forward to hearing how FDA is implementing 

FSMA and what challenges remain to protect our Nation’s food 

supply. I don’t think anyone else wants my time, so I’ll yield back, 

Mr. Chairman. 

[The prepared statement of Mr. Pallone follows:] 

PREPARED STATEMENT OF HON. FRANK PALLONE, JR. 

This committee has a long history of overseeing food safety. Over the last decade, 

we have held multiple hearings examining the Food and Drug Administration’s 

oversight of food recalls and the agency’s authority to protect the Nation’s food supply. 

FDA plays a critical role—in fiscal year 2017 alone, FDA oversaw more than 3,600 

recalls. This is no small task, but we have seen cases that exposed weaknesses in 

FDA’s ability to respond to these threats. 

For example, in 2007, a committee investigation into a Salmonella outbreak identified serious flaws in our food safety network. In 2010, the committee found that 

FDA had limited authority to ensure compliance and did not always take swift action when needed. 

Witnesses repeatedly told this committee that FDA lacked sufficient authority to 

address weaknesses in our food safety system. That’s why Congress passed the FDA 

Food Safety Modernization Act (FSMA) in 2011. FSMA significantly reformed FDA’s 

overall approach to food safety and gave FDA new authorities to strengthen the 

food-recall process. 

For instance, FDA now has the ability to mandate a recall when a product poses 

a risk of serious adverse health consequences. This is a significant tool because we 

have seen cases of manufacturing firms reluctant to cooperate with FDA. Thanks 

to FSMA, firms are also now required to have recall plans in place to help prepare 

before a contamination occurs. 

FSMA provided these new tools, but it is up to FDA to make sure they are being 

put to good use. That’s why this hearing is so important—we need to hear about 

how FDA is implementing FSMA and whether things have improved since we 

passed it into law. 

A recent Office of Inspector General report sheds some light on that question and 

suggests that FDA still may not always adequately oversee food recalls. The Inspector General reported that FDA did not always effectively monitor firms during a recall, such as ensuring that firms initiate the recalls promptly. 

10 

Some of the cases highlighted in the report are particularly troubling. For example, between 2012 and 2014, nut butter contaminated with Salmonella sickened 14 

people in 11 States. FDA identified the source of the outbreak in March of 2014, 

but the products were not fully recalled until August of that year, 165 days later. 

The Inspector General also cited a series of recalls of cheese products that were 

contaminated with Listeria and led to one infant’s death and two lost pregnancies. 

I know everyone on this committee will agree that even one fatality is too many. 

While we should recognize that these issues are complex and every recall poses 

a unique challenge, these findings demonstrate that FDA must exercise judicious 

yet forceful oversight when the public’s health is at risk. 

I look forward to hearing how FDA is implementing FSMA and what challenges 

remain to protect our Nation’s food supply. 

I yield back. 

Mr. HARPER. The gentleman yields back. I ask unanimous consent that the Members’ written opening statements be made part 

of the record. And, without objection, they will be entered into the 

record. 

I’d now like to introduce our panel of witnesses for today’s hearing. Today we have Ms. Gloria Jarmon, who is the Deputy Inspector General of Audit Services for the Office of Inspector General at 

HHS. We welcome you today. And Mr. Douglas Stearn, the Director of the Office of Enforcement and Import Operations in the Office of Regulatory Affairs at the FDA. Welcome to you both, and 

thank you for being here today to help and to provide testimony. 

And we look forward to the opportunity to discuss the FDA’s foodrecall process. 

You are aware that the committee is holding an investigative 

hearing, and when so doing, it has the practice of taking testimony 

under oath. Do you have any objection to testifying under oath? 

Mr. STEARN. No, sir. 

Ms. JARMON. [No verbal response.] 

Mr. HARPER. Both witnesses have indicated no. The Chair then 

advises you that, under the rules of the House and the rules of the 

committee, you’re entitled to be accompanied by counsel. Do you 

desire to be accompanied by counsel during your testimony today? 

Mr. STEARN. No, sir. 

Ms. JARMON. [No verbal response.] 

Mr. HARPER. Both witnesses have indicated no. In that case, if 

you would, please rise and raise your right hand, and I will swear 

you in. 

Do you swear that the testimony you’re about to give is the 

truth, the whole truth, and nothing but the truth? 

Mr. STEARN. I do. 

Ms. JARMON. I do. 

Mr. HARPER. Thank you. And you may both be seated. You’re 

now under oath and subject to the penalties set forth in Title 18, 

Section 1001 of the United States Code. You may now give a 5- 

minute summary of your written testimony. And we will recognize 

Ms. Jarmon first for your testimony. 

11 

STATEMENTS OF GLORIA L. JARMON, DEPUTY INSPECTOR 

GENERAL FOR AUDIT SERVICES, OFFICE OF INSPECTOR 

GENERAL, DEPARTMENT OF HEALTH AND HUMAN SERVICES, AND DOUGLAS W. STEARN, ACTING DEPUTY DIRECTOR 

FOR REGULATORY AFFAIRS, CENTER FOR FOOD SAFETY 

AND APPLIED NUTRITION, AND DIRECTOR, OFFICE OF ENFORCEMENT AND IMPORT OPERATIONS, OFFICE OF REGULATORY AFFAIRS, FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES 

STATEMENT OF GLORIA L. JARMON 

Ms. JARMON. Good morning, Chairman Harper, Ranking Member 

DeGette, and other members of the subcommittee. I am Gloria 

Jarmon, Deputy Inspector General, Audit Services, Office of Inspector General, U.S. Department of Health and Human Services. I appreciate the opportunity to appear before you today. 

Conducting audits, evaluations, and inspections aimed at food 

safety is a priority for OIG and remains key to our mission of protecting the health and safety of the American people. I’m here 

today to discuss our recently published audit report on the food-recall process at the Food and Drug Administration and our recommendations for improving that process. 

This audit reviewed documentation for 30 recalls, which were 

judgmentally selected from the 1,557 food recalls reported to FDA 

between October 2012 and May 4, 2015. For the 30 recalls we reviewed, we found that FDA’s food-recall process was not always effective and efficient in ensuring the Nation’s food supply. Specifically, we identified deficiencies in FDA’s oversight of recall initiation, FDA’s monitoring of recalls, and the recall information captured and maintained in the FDA’s recall data system. 

My testimony today focuses on key aspects of these three findings and OIG’s recommendations to FDA for improving its food-recall process. First, our review of FDA’s oversight of firm initiator 

recalls determined that FDA cannot always ensure that firms initiated recalls promptly and did not always evaluate health hazards 

in a timely manner. 

To improve FDA’s oversight of recall initiation, we recommended 

that FDA establish set internal timeframes for discussing the possibility of a voluntary recall with a firm and initiating the use of 

its mandatory recall authority. In addition, we recommended that 

FDA take several specific actions aimed at ensuring that health 

hazard evaluations are completed in a timely manner. 

Second, our audit also identifies several deficiencies in FDA’s 

monitoring of firm initiator recalls. Specifically, we found that FDA 

did not always issue audit checks at the appropriate level, complete 

audit checks as assigned, and collect timely and complete status reports from recalling firms. To improve FDA’s monitoring of recalls, 

we recommended that FDA take steps to ensure that audit checks 

are assigned at the level specified in the audit program and that 

product distribution lists are complete and accurate. 

It takes specific actions to help ensure that audit checks are completed in a timely manner and implement procedures for requesting status reports of initiation of a recall and follow up with firms 

that do not provide timely or complete status reports. 

12 

Third, our review of FDA’s recall data system determined that 

FDA did not always track key recall data and maintain accurate 

recall data. To help ensure the completeness and accuracy of data 

in the data systems and give FDA staff involved in managing recalls access to information about key events, we recommended, 

among other things, that FDA consider adding to its recall data 

system, or another FDA system, a field for the date FDA learns of 

a potentially hazardous product, and clarify the definition of recall 

initiation date in its policies and procedures, and ensure a consistent understanding of recall initiation date among recall personnel. 

In FDA’s comments on our report, it agreed with our conclusion 

that it needs to help ensure that recalls are initiated promptly in 

all circumstances. FDA said it will continue to consider the results 

of our audit as it moves forward to operate its SCORE team, which 

stands for Strategic Coordinated Oversight of Recall Execution. 

This SCORE initiative was developed to establish set timeframes, 

expedite decision making to recall cases forward, and improve electronic recall data. 

We appreciate the steps that FDA has taken, as well as the steps 

it plans to take, to address the vulnerabilities we identified during 

our audit. OIG work has demonstrated ways for FDA to improve 

its oversight of the food-recall process, and we will continue to 

work with the FDA and Congress to help ensure the safety of the 

Nation’s food supply. 

Again, thank you for the opportunity to testify this morning, and 

I’m happy to answer your questions. 

[The prepared statement of Ms. Jarmon follows:] 

13 


res:tin10!11Y Before the United States House 

Committee on Energy and Commerce 

Subcommittee on 

19,2018 

9:00a.m. 

Location: 2123 Rayburn House Office Building 
14 


Testimony of Gloria L. Jarmon 

Deputy Inspector General for Audit Services 

U.S. Department of Health and Human Services, Office oflnspector General 

Good morning, Chairman Harper, Ranking Member DeGette, and Members of the 

Subcommittee. I am Gloria Jarmon, Deputy Inspector General for Audit Services for the Office 

oflnspector General (OIG), U.S. Department of Health and Human Services. I appreciate the 

opportunity to appear before you to discuss our recently published audit report on the food-recall 

process at the Food and Drug Administration (FDA) and our recommendations for improving 

that process. 

Food recalls are critical to preventing people from consuming food that may be harmful. Prior 

OIG reviews have focused on FDA oversight offood recalls and inspections offood facilities. 1 

The FDA Food Safety Modernization Act gave FDA new statutory authority, including the 

authority to order mandatory food recalls. Our recent audit, released at the end of December 

2017, was aimed at determining whether FDA is fulfilling its responsibility to safeguard the 

Nation's food supply now that it has mandatory recall authority.2 

This audit reviewed documentation for 30 recalls, including 23 Class I and 7 Class II recalls, 

which were judgmentally selected from the 1,557 food recalls reported to FDA between October 1 

2012, and May 4, 2015. In a Class I recall, there is a reasonable probability that the use of or 

exposure to the product could cause serious adverse health consequences or death. In a Class II 

recall, the use of or exposure to a product may cause temporary or medically reversible adverse 

health consequences or the probability of serious adverse health consequences or death is remote. 

Because we selected a judgmental sample, the results are informative about deficiencies in 

FDA's food-recall oversight process but are not representative of the full population of FDA 

recalls. For the 30 food recalls we reviewed, we found that FDA's food-recall process was not 

always effective and efficient in ensuring the safety of the Nation's food supply. Specifically, 

we identified deficiencies in: 

• FDA's oversight of recall initiation, 

• FDA's monitoring of recalls, and 

• the recall information captured and maintained in FDA's electronic Recall Enterprise 

System (RES). 

1 Review of the Food and Drug Administration's Monitoring of Pet Food Recalls (A-01-07-01503, August 2009). 

Available online at https://oig.hhs.gov/oas/reports/region 1/1070 1503.pdf. Review of the Food and Drug 

Administration's Monitoring of Imported Food Recalls (A-01-09-0 1500, June 2011 ). Available online at 

https://oig.hhs.gov/oas/reports/regionl0/10901500.pdf. Challenges Remain in FDA's Inspections of Domestic Food 

Facilities (OEI-02-14-00420, September 2017). Available online at https:l/oig.hhs.gov/oeilreports/oei-02-14-

00420.pdf. 

2 The Food and Drug Administration's Food-Recall Process Did Not Always Ensure the Safety of the Nation's Food 

Supply (A-0 1-16-01502, December 2017). Available online at https:l/oig.hhs.gov/oas/reports/region 111160 1502.pdf. 

Committee on Energy and Commerce, Subcommittee on Oversight and Investigations 

January 19, 2018 
15 


My testimony today focuses on key aspects of these three findings and OIG's recommendations 

to FDA for improving its food-recall process. I will also highlight some of the actions that FDA 

officials told us that they took in response to the Early Alert of Significant Preliminary Findings 

(early alert) we issued in June 2016, in advance of the audit report. That early alert notified FDA 

that preliminary evidence suggested it did not have policies and procedures in place to ensure 

firms initiated food recalls promptly. According to FDA, our review and early alert were 

catalysts to major changes by FDA to strengthen its oversight of the food-recall process and its 

enforcement strategies. Although progress appears to have been made, more is needed to protect 

the Nation's food supply. 

FDA's Oversight of Food Recalls 

A recall is a firm's3 removal or correction of a marketed product that FDA considers to be in 

violation of the Federal Food, Drug and Cosmetic Act (FD&C Act) and against which FDA 

would initiate a legal action (e.g., seizure). When FDA learns about a potentially hazardous 

product, FDA may discuss the possibility of a recall with a firm without specifically requesting a 

recall. If the firm decides to recall the product, the firm's action is considered a voluntary recall. 

When a firm promptly initiates a voluntary product recall, FDA does not need to take further 

action to initiate the recall. 

If a firm fails to voluntarily recall the product, or FDA determines that the recall is ineffective, 

FDA may take appropriate regulatory action. One action that FDA may consider is a mandatory 

recall. To use its mandatory recall authority, FDA must determine that there is a reasonable 

probability that the food is adulterated under section 402 of the FD&C Act or misbranded under 

section 403(w) of the FD&C Act and that it will cause serious adverse health consequences or 

death to humans or animals.4 FDA's mandatory recall procedures require it to complete a Health 

Hazard Evaluation (HHE), a tool used by FDA to evaluate the health hazard presented by a 

product, classify a recall, and assess a firm's recall strategy, before using its mandatory recall 

authority.5 

Deficiencies in FDA's Oversight of Recall Initiation 

Our review ofFDA's oversight of firm-initiated recalls determined that FDA (I) could not 

always ensure that firms initiated recalls promptly and (2) did not always evaluate health hazards 

in a timely manner. 

'Finns are generally individuals or entities responsible for the product's manufacture and distribution. 

4 Section 206 of the FSMA, P.L. No. 111-353 (enacted January 4, 2011), amending and adding section 423 to the 

Federal Food, Drug, and Cosmetic Act. 

5 Mandatory Food Recalls, document number ORA-OEI0.055, version 1.1, dated December 27, 2012. 

Committee on Energy and Commerce, Subcommittee on Oversight and Investigations 

January 19,2018 2 
16 


FDA Could Not Always Ensure That Firms Initiated Recalls Promptly 

We found that FDA could not always ensure that firms initiated recalls promptly because FDA 

did not have adequate procedures to ensure that firms take prompt and effective action in 

initiating voluntary recalls. 

For the 30 recalls that we reviewed, initiation of the recall occurred anywhere from 9 days before 

to 303 days after FDA learned that the product was potentially hazardous. Firms initiated these 

recalls an average of 57 days (with a median of29 days) after FDA learned of the potential 

hazard. For example, one firm did not initiate a Class I recall of an adulterated dietary 

supplement until 303 days after receiving a warning letter from FDA stating that the product was 

adulterated. In that case, FDA and the firm disagreed about whether the supplement was lawful. 

We found that FDA had not established risk-based internal timeframes for reaching certain 

milestones in the recall process, such as when FDA recall staff should request that firms 

voluntarily recall their products, which delayed it from taking further action in some recalls. For 

instance, when firms were reluctant to voluntarily initiate timely recalls, delays were more likely, 

and FDA's food-recall initiation process could not ensure the efficiency and effectiveness of 

food recalls. If FDA had established risk-based internal time frames, it might have identified 

reluctant firms earlier in the food-recall process and taken appropriate action to protect public 

health. 

FDA Did Not Always Evaluate Health Hazards in a Timely Manner 

FDA uses an HHE to evaluate the health hazard presented by a product, classify a recall, and 

assess a firm's recall strategy. If a product is identical or similar to a previously classified 

recalled product, a precedent HHE may be used. FDA was unable to rely on a precedent HHE 

for 14 of the 30 recalls that we audited. In those 14 recalls, completion of the HHE ranged from 

8 working days before FDA learned of a planned or in-progress recall to 209 working days after 

learning of a planned or in-progress recall. On average, FDA took 47 working days (with a 

median of27 working days) to complete the HHEs associated with these 14 recalls. 

We found that FDA did not complete some HHEs in a timely manner for several reasons. One 

reason was that FDA district staff located throughout the country did not always submit a recall 

alert about a planned or in-progress food recall to the RES within the timeframe outlined in its 

procedures. These recall alerts trigger the initiation of the HHE process. According to FDA's 

Regulatory Procedures Manual (RPM), a recall alert should be submitted as soon as possible, but 

preferably within 24 hours of the district learning of a planned or in-progress recall. For the 30 

recalls that we audited, FDA district staff submitted the recall alert an average of 34 days after 

learning of a planned or in-progress recall. 

Without a timely HHE, FDA could not send out to firms timely notification letters with FDA's 

formal written assessment of the firms' recall strategy and any suggested strategy revisions or 

request periodic status reports. Furthermore, without a timely HHE, FDA could not establish 

whether there was a reasonable probability that the product would cause serious adverse health 

consequences or death. Because FDA must establish this reasonable probability in order to 

Committee on Energy and Commerce, Subcommittee on Oversight and Investigations 

January 19,2018 
17 


exercise its mandatory recall authority, FDA was not always in a position to determine whether it 

should order a mandatory food recall. 

Key GIG Recommendations for Improving FDA's Oversight of Recall Initiation 

To improve FDA's oversight of recall initiation, we recommended that FDA establish set 

timeframes for: 

• discussing the possibility of a voluntary recall with a firm and 

• initiating the use of its mandatory recall authority after it has made the determination that 

the legal standard for use of that authority has been met and a firm is not willing to 

voluntarily conduct a recall. 

In addition, we recommended that FDA take several specific actions aimed at ensuring that 

HHEs are completed in a timely manner. 

Deficiencies in FDA's Monitoring of Recalls 

We identified several deficiencies in FDA's monitoring of firm-initiated recalls. Specifically, we 

found that FDA did not always (1) issue audit check assignments at the appropriate level, 

(2) complete audit checks in accordance with its procedures, and (3) collect timely and complete 

status reports from recalling firms. 

FDA Did Not Always Issue Audit Check Assignments Consistent With the Level in the Proposed 

Audit Program 

FDA monitoring district staff should establish a proposed audit program for monitoring a recall, 

which should include a timetable for reviewing the recall status and the level and type of audit 

checks. A recall "audit check" is a visit, telephone call, or letter (or a combination thereof) from 

an FDA district office to a consignee (anyone who received, purchased, or used the product 

being recalled) of a recalled product intended to verify that the consignee has been notified of the 

recall and has taken appropriate action. Depending on the audit check level, district offices 

should contact a certain percentage of consignees. FDA relies on the recalling firm to provide it 

with a distribution list of consignees that received the recalled product. 

For 8 of the 27 recalls in our audit that required audit checks, FDA assigned fewer audit checks 

to its district offices than were called for by the audit check level in the proposed audit program. 

For example, in one Class I recall, the audit program proposed audit check Level A, which 

required the district offices to contact all 19 of the domestic consignees that received the recalled 

product, but FDA assigned audit checks for only 12 consignees. 

FDA did not always assign audit checks consistent with the audit check levels in the audit plan 

because oversight of FDA's recall coordinators was insufficient, and the consignee distribution 

lists that FDA obtained from recalling firms were not always complete or accurate. Because 

Committee on Energy and Commerce, Subcommittee on Oversight and Investigations 

January 19,2018 4 
18 


fewer audit checks were assigned than were required by the audit check level, there was an 

increased risk that consignees were not aware of the recall and recall instructions. 

FDA Did Not Always Complete Audit Checks in Accordance With Its Procedures 

We found that FDA did not always complete audit checks in accordance with timeframes set out 

in its procedures. As a result, FDA could not ensure that consignees took timely, appropriate 

action to remove harmful products from retail stores and from other points in the distribution 

chain. FDA's RPM states that FDA should normally assign audit checks to its district offices 

within I 0 days of the firms' recall communication with consignees. The RPM states that the 

district office should consider the audit check assignments "high priority" and complete them 

within I 0 days of assignment, if possible. In certain cases, FDA can use State agencies and 

third-party contractors to conduct audit checks. 

For 5 of the 30 recalls in our audit, FDA determined that audit checks were not required. For 21 

of the remaining 25 recalls that required audit checks, FDA did not complete the audit checks 

within the timeframes set out in its procedures. On average, the audit checks for these 21 recalls 

took 118 days (with a median of69 days) to complete from the time of the firms' first recall 

communication. In one case, FDA did not complete the final audit check related to a Class I 

recall of a mislabeled product until547 days after the firm first notified its consignees of the 

recall. Three of the 18 audit checks that FDA conducted for this recall were conducted more 

than 300 days after the firm issued the recall communication. This means that the mislabeled 

product was still on the shelves of three retail stores, and consumers remained at risk. 

For all 21 recalls that did not have audit checks completed in a timely manner, we noted that 

FDA did not obtain assistance from State agencies or third-party contractors to help complete the 

audit checks. We also found that communication among the FDA staff conducting audit checks, 

recall coordinators, and district offices was not always effective in ensuring that audit checks 

were completed in a timely manner. In addition, none of FDA's data systems could be used to 

assist staff with tracking the status of audit checks. As a result, FDA could not ensure that 

consignees took timely, appropriate action and removed harmful products from the market. 

FDA Did Not Always Collect Timely and Complete Status Reports From Recalling Firms 

FDA should request periodic status reports from recalling firms so that FDA can monitor and 

assess the progress of a recall. Status reports should contain specific information, including the 

number and results of the firm's effectiveness checks. Effectiveness checks help firms and FDA 

verify that all known, affected consignees have received notification about a recall and have 

taken appropriate action. 

FDA did not always collect timely status reports. For 11 of the 30 recalls covered by our audit, 

FDA either did not request or did not collect status reports. For the remaining 19 recalls, the 

average number of days for FDA to collect the first status report was 143 days (with a median of 

122 days and range of 14 to 605 days) after the recall was initiated. In addition, when FDA 

collected status reports, they were not always complete. Of the 19 recalls in which FDA 

Committee on Energy and Commerce, Subcommittee on Oversight and Investigations 

January 19, 2018 
19 


obtained at least 1 status report, we found that status reports associated with 5 recalls did not 

contain complete effectiveness check information. 

In one Class I recall that we audited, FDA did not officially request status reports from the 

recalling firm until 57 days after the recall was initiated and did not receive a status report until 

605 days after the recall was initiated. There was not any evidence that FDA followed up with 

the firm about the status report in that time frame, and, in addition to being untimely, the status 

report that FDA received did not contain information about the number and results of the firm's 

effectiveness checks. 

FDA's procedures to collect timely and complete status reports from recalling firms were 

inadequate because they did not require staff to request status reports at the time a recall was 

initiated. In addition, FDA did not always follow up with firms when status reports were not 

provided, were provided late, or were incomplete. Without obtaining timely and complete status 

reports from a recalling firm, FDA could not adequately monitor the progress and effectiveness 

of the recall and assess whether additional action was necessary to protect the public. 

Key 0/G Recommendations for Improving FDA's Monitoring of Recalls 

To improve FDA's monitoring of recalls, we recommended that FDA: 

• take steps to ensure that audit checks are assigned at the level specified in the audit 

program and to ensure the completeness and accuracy of consignee distribution lists, 

• take specific actions to help ensure that audit checks are completed in a timely manner,6 

and 

• implement procedures for requesting status reports at the initiation of a recall and follow 

up with firms that do not provide timely or complete status reports. 

Deficiencies in FDA's Electronic Recall Enterprise System 

Our review of FDA's electronic recall data system determined that FDA did not always (I) track 

key recall data and (2) maintain accurate recall data. 

FDA Did Not Always Track Key Recall Data in RES 

FDA uses RES, an electronic data system, to help manage recalls. RES also provides a central, 

searchable database that FDA can use to track information, generate reports about recall 

activities, and disseminate those reports. 

We found that RES did not have a field for tracking all information necessary for FDA to 

effectively monitor recall activities and assess the timeliness of recalls. Specifically, RES did 

6 Specifically, we recommended that FDA increase its use of third parties to perform audit checks, strengthen 

internal communication during the audit check process, and improve the ability ofFDA information systems to track 

and monitor the status of audit checks. 

Committee on Energy and Commerce, Subcommittee on Oversight and Investigations 

January 19,2018 6 
20 


not track the date that FDA learned a product was potentially hazardous. Therefore, FDA could 

not use RES to measure the amount of time between the date FDA learned that a product was 

potentially hazardous and the date a firm initiated a voluntary recall. 

For example, in a Class I recall involving hazelnuts contaminated with Salmonella, FDA learned 

that the hazelnuts were potentially hazardous on December 2, 2012. The firm initiated the recall 

on May 2, 2013. However, because the RES did not have a field for the date that FDA first 

learned the product was potentially hazardous, FDA could not use the RES to calculate that it 

took the firm !51 days to initiate the recall after FDA first learned the product was potentially 

hazardous. 

FDA staff documented the date that FDA learned a product was potentially hazardous only in the 

recall files. FDA officials stated that tracking this date for all recalls would be time consuming 

and difficult because the date may be located in different FDA systems or obtained from sources 

outside of FDA. However, without tracking this date in the RES, FDA could not effectively 

identify and respond to firms that were not prompt in recalling food products that FDA was 

aware presented a risk to public health. 

FDA Did Not Always Maintain Accurate Recall Data 

FDA did not always enter accurate recall initiation dates in the RES. The RES User Manual 

defines the recall initiation date as the "date that the recall action was initiated by a company." 

However, for 11 of the 30 recalls we sampled, we determined that the recall initiation date in 

RES was off by an average of 16 days (with a median of 4 days). The inaccurate recall initiation 

dates ranged from 1 day before the initiation date inputted into the RES to 89 days after. 

For example, in a Class I recall involving undeclared allergens in a dietary supplement, June 5, 

2013, was entered as the recall initiation date. Based on a review of the recall file, however, we 

determined that recall was not initiated until the firm began notifying its consignees of the recall 

on September 2, 2013. The initiation date in the RES was incorrect by approximately 3 months 

(89 days). 

FDA's RES User Manual did not clearly define the term "recall initiation date" and, therefore, 

FDA staff input other dates into the RES. In the Class I recall discussed above, the recall 

coordinator explained that she entered the date the firm started discussing a possible recall as the 

recall initiation date. In addition, FDA did not have a data quality assurance process to help 

ensure that RES data were both accurate and complete. 

Without an accurate recall initiation date documented in the RES, FDA could not use the RES to 

determine the length oftime it took a firm to initiate a recall. As a result, FDA did not have 

assurance that the data in the RES were accurate and that the RES was reporting correct 

information. 

Committee on Energy and Commerce, Subcommittee on Oversight and Investigations 

January 19, 2018 7 
21 


Key OIG Recommendations for Improving the Completeness and Accuracy of FDA's Electronic 

Data Systems 

To help ensure the completeness and accuracy of data in its data systems and give FDA staff 

involved in managing recalls access to information about key events, we recommended that 

FDA: 

• consider adding to RES or another FDA system a field for the date FDA learns of a 

potentially hazardous product, 

• establish performance measures for the amount of time between the date FDA learns of a 

potentially hazardous product and the date a firm initiates a voluntary recall, 

• clarifY the definition of"recall initiation date" in its policies and procedures and ensure a 

consistent understanding of "recall initiation date" among recall personnel, and 

• develop and implement a data quality assurance process to ensure that the RES contains 

accurate information. 

FDA Initiatives to Improve the Food-Recall Process 

In response to our early alert, FDA informed us of several changes it had taken to improve the 

way it manages and oversees food recalls. 

In April2016, FDA established a team of senior FDA leaders charged with making decisions 

during the most challenging and high-risk food-recall cases. This team is called SCORE, which 

stands for Strategic Coordinated Oversight of Recall Execution. According to FDA, SCORE has 

reviewed and directed a large number of operations in the most difficult cases that FDA has 

faced since we issued our early alert, and has made a difference in ensuring that FDA acts 

quickly to investigate and reduce consumer exposure to potentially harmful foods on the market. 

In September 2016, FDA's Office of Regulatory Affairs (ORA) designed and implemented a 

plan to audit ORA's recall program across all regulated product areas. ORA described the 

program as a "quality system recall audit plan" that provides for both "traditional auditing and 

continuous monitoring of the recall program." 

Finally, in December 2016, ORA completed a project charter that implemented a recall strategic 

plan. According to FDA, this plan is designed to identifY strategic priorities that optimize FDA's 

policies and procedures regarding the recall of FDA-regulated products that pose a public health 

risk. 

While we have not had the opportunity to assess the impact of these changes, we are encouraged 

by the proactive steps that FDA has taken to improve the food-recall process. 

Committee on Energy and Commerce, Subcommittee on Oversight and Investigations 

January 19,2018 
22 


Conclusion 

In its comments on our report, FDA agreed with our conclusion that it needs to help ensure that 

recalls are initiated promptly in all circumstances and said that it will consider the results of our 

review as it continues to operate the SCORE initiative. Among other things, FDA stated that it is 

initiating a new quality system audit process and a plan to provide early notice to the public and 

more guidance to staff. We appreciate the steps FDA has taken as well as the steps it plans to 

take to address the vulnerabilities we identified during our audit. 

We also appreciate the Subcommittee's interest in our audit and thank you for the opportunity to 

testifY on ways for FDA to improve its oversight of the food-recall process. Conducting audits, 

evaluations, and inspections aimed at food safety is a priority for OJG and remains key to our 

mission of protecting the health and safety of the American people. Since FY 2015, OIG has 

increased its efforts to oversee FDA by (I) assessing FDA's implementation of new authorities, 

(2) monitoring existing FDA programs, (3) reviewing FDA's readiness to address new threats to 

public health and safety, and (4) investigating FDA's administration and fraud, waste, and abuse. 

OIG will continue to work with FDA and Congress to help ensure the safety of the Nation's food 

supply. 

I look forward to answering your questions. 

Committee on Energy and Commerce, Subcommittee on Oversight and Investigations 

January 19,2018 9 
23 

Mr. HARPER. Thank you, Ms. Jarmon. The Chair will now recognize Mr. Stearn for 5 minutes for the purposes of a summary of his 

written testimony. Thank you and welcome. 

STATEMENT OF DOUGLAS W. STEARN 

Mr. STEARN. Thank you, sir. Good morning, Chairman Harper, 

Ranking Member DeGette, and members of the subcommittee. I am 

Douglas Stearn, Director of Enforcement and Import Operations in 

the Office of Regulatory Affairs and the Acting Deputy Director for 

Regulatory Affairs for the Center for Food Safety and Applied Nutrition. 

We appreciate the opportunity to provide you with information 

about how we oversee recalls of FDA-regulated products. FDA is 

committed to continuously improving our practices to ensure that 

food recalls are initiated, overseen, and completed promptly and effectively to best protect consumers. 

In this regard, we appreciate the Office of Inspector General’s 

focus on this subject. I would like to thank the committee for the 

opportunity to report on major changes FDA has made in response 

to OIG’s investigation. When we learn about a food in the marketplace that may be unsafe, we must act quickly to keep people from 

getting sick or being harmed. 

FDA has authority to act in a variety of ways, but often the fastest and most efficient way to ensure unsafe foods are recalled 

quickly is to work directly with the involved companies while simultaneously providing the public with timely, accurate information that they can act on, making sure FDA has effective recall 

practices in place, and we take immediate action to address unsafe 

foods are high priorities for the agency. 

FDA has wide-ranging oversight responsibilities. In the foods 

areas, FDA is responsible for oversight and regulation of more than 

300,000 registered food facilities and more than 12 million lines of 

imported food products per year. FDA is also responsible for overseeing industry recalls of food products. In the most recent fiscal 

year, FDA oversaw more than 3,600 food product recalls. 

The recent OIG review of a selected group of 30 food recalls initiated between 2012 and 2015 found some unacceptable delays in the 

removal of food from the market. This group included a number of 

challenges, including criminal behavior from a firm that hid critical 

information; new technology used to link clinical samples to their 

source; and key questions about how broad a recall should be. 

One of the most significant steps FDA has taken was in April 

2016. FDA established a team of senior leaders charged with reviewing complex or unusual food safety situations and determining 

the proper action to address the problem. SCORE, the Strategic Coordinated Oversight of Recall Execution, meets at least weekly and 

makes decisions about what actions to take. 

SCORE has made a difference in addressing complicated, challenging, and unusual incidents. The team has been involved in 

cases that range from lead contamination of a dietary supplement, 

Salmonella contamination of powdered milk, E. coli O157:H7 in soy 

nut butter, to Listeria in hummus, soft cheese, and smoked fish. 

In addition to facilitating recalls and import alerts for the detention of products entering the U.S., SCORE helped expedite the regVerDate Mar 15 2010 11:46 Jan 08, 2019 Jkt 037690 PO 00000 Frm 00027 Fmt 6633 Sfmt 6633 I:\115THCONGRESS\115X93FDARECALLSAWAITSTEARNQFRR\115X93FDARECALLSPD
24 

istration suspension of two food facilities, actions that prohibit food 

distribution after recall. In addition to SCORE, FDA has put in 

place several additional procedural changes. Last year, after a comprehensive review of our recall process, we developed a new strategic plan to improve recall management. The plan helps to standardize how FDA assesses a company’s recall efforts, establishes 

monitoring of recall activities, provides additional training and 

guidance to our staff to monitor and assess recall effectiveness, and 

increases the timeliness and amount of recall information provided 

to the public. 

The procedural changes FDA has completed since the OIG investigation establish a monthly monitoring system and regular audits, 

improve recall recommendations and recall audit check assignments, expand third-party recall audit checks, improve the pathway for foreign suppliers to provide information about recalls to 

FDA, and create a set of best practices for our State partners. 

FDA will continue to implement additional changes that will continue to improve how we protect the public through the recall process and through consumer messages. FDA has improved its recall 

classification process and now averages 13 to 15 days, down dramatically from a year earlier. 

Furthermore, the agency is focused on providing more information to consumers in a number of ways. We now publicize recalls 

prior to classification. Yesterday, we released a draft guidance to 

improve public awareness in additional recall areas. And the Commissioner also announced a way to share additional information 

with consumers during recalls, such as specific stores where recalled food may have been sold. 

FDA is also currently pursuing major initiatives that have implications for the oversight of recalls in the future. The Food Safety 

Modernization Act shifts the focus of the food safety system from 

responding to contamination to preventing it and will change how 

companies prevent and respond to food safety issues. 

In addition, FDA field operations have recently undergone a reorganization to meet today’s challenges by specializing recall coordinators and other FDA staff. 

Thank you for the opportunity to discuss FDA’s recall processes. 

I would be happy to answer any questions you may have. 

[The prepared statement of Mr. Stearn follows:] 

25 


STATEMENT OF 

DOUGLAS W. STEARN, J.D. 

ACTING DEPUTY DIRECTOR FOR REGULATORY AFFAIRS 

CENTER FOR FOOD SAFETY AND APPLIED NUTRITION AND 

DIRECTOR OF THE OFFICE OF ENFORCEMENT AND IMPORT OPERATIONS 

OFFICE OF REGULATORY AFFAIRS 

FOOD AND DRUG ADMINISTRATION 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

BEFORE THE 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS 

COMMITTEE ON ENERGY AND COMMERCE 

U.S. HOUSE OF REPRESENTATIVES 

"SAFETY OF THE U.S. FOOD SUPPLY: CONTINUING CONCERNS OVER THE 

FOOD AND DRUG ADMINISTRATION'S FOOD RECALL PROCESS" 

JANUARY 19, 2018 

FOR RELEASE ONLY UPON DELIVERY 
26 


INTRODUCTION 

Good morning, Chairman Harper, Ranking Member DeGette, and members of the 

Subcommittee. I am Douglas Steam, director of the Office of Enforcement and Import 

Operations in the Office of Regulatory Affairs of the U.S. Food and Drug Administration (FDA 

or the Agency) within the Department of Health and Human Services. Currently, I am serving as 

the acting deputy director for regulatory affairs at the Center for Food Safety and Applied 

Nutrition within FDA. I am also the co-chair of the Strategic Coordinated Oversight of Recall 

Execution {SCORE). 

We appreciate the opportunity to provide you with information about how we oversee recalls of 

FDA-regulated products that can harm consumers. FDA is committed to continuously improving 

our policies and practices to ensure that food recalls are initiated, overseen, and completed 

promptly and effectively to best protect consumers. In this regard, we appreciate the Office of 

Inspector General's {OIG's) focus on this subject and would like to thank the committee for the 

opportunity to report on major changes FDA has made in response to OIG's investigation. 

When we learn about a food in the marketplace that may be unsafe, we must act quickly to keep 

people from getting sick or being harmed. Iffoodbome illness has already occurred, we also 

must act quickly to keep more people from becoming ill. FDA has authority to act in a variety of 

ways, but often the fastest and most efficient way to ensure unsafe foods are recalled quickly is 

by working directly with the involved companies while simultaneously providing the public with 

timely, accurate information that they can act on. Making sure FDA has effective recall practices 

in place, and that we take immediate action to address unsafe foods, are high priorities of the 

Agency. Our recall authorities- and how we deploy them are a cornerstone of our vital 

consumer protection mission. 

ROLES OF INDUSTRY AND FDA IN CONDUCTING RECALLS 

FDA has wide-ranging oversight responsibilities. In the foods area, FDA is responsible for 

inspecting more than 88,000 domestic registered food facilities that manufacture, process, pack, 

or hold food. In addition to domestic food facilities, FDA is also responsible for ensuring the 

safety of food imported from the more than 212,000 registered foreign food facilities, producing 

more than 12 million food commodity import occurrences into the United States in fiscal year 

2016. In addition to inspections of those food facilities, FDA is responsible for overseeing the 

industry's recall of food products that present a risk of injury or gross deception or are otherwise 

violative. In recent years, FDA has overseen thousands of food recalls annually. In FY 2017 

alone, FDA oversaw more than 3,600 product recalls. 
27 


Until the FDA Food Safety Modernization Act (FSMA) was signed into law in 2011, with the 

exception of infant formula, food recalls were defined as voluntary actions that were dependent 

on manufacturers and distributors to effectively discharge their recall responsibilities. Recalls 

were considered exclusively as voluntary alternatives to court actions against non-compliant 

firms that FDA might otherwise initiate. FDA's role in this voluntary process was to monitor 

recalls and assess the adequacy of firms' efforts so that the Agency could take additional action 

when necessary. Subpart C of Part 7 of FDA's regulations (Title 21, Code of Federal 

Regulations, Sections 7.40-59) governs the voluntary product recalls, and FDA also has 

published guidance for recalling firms (see https://wwwfda.gov/Safety/Recalls/ 

IndustryGuidance/ucml29259.htm). FDA's guidance on voluntary recalls describes actions that 

FDA and the industry can take to carry out their respective recall responsibilities. The underlying 

premise of this guidance is that firms producing and marketing FDA-regulated products assume 

a responsibility to timely remove violative products from the marketplace when removal is 

necessary to protect the public health. 

Under FSMA, FDA has authority to mandate a recall of a food product when FDA determines 

that there is a reasonable probability that an article of food is adulterated under section 402 of the 

Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) and/or is misbranded under 

section 403(w) of the FD&C Act and where there is a reasonable probability that the use of or 

exposure to such food would cause serious adverse health consequences or death to humans or 

animals. In May 2015, FDA issued guidance explaining the mandatory recall provision. (See 

https:/lwwwfda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatorylriformation/ 

ucm445428.htm.) We believe FDA's mandatory recall authority has played an important role in 

motivating firms to initiate voluntary recalls. When the firm does not take the appropriate 

actions, FDA can initiate use of the mandatory recall authority, which it has done on two 

occasions. 

The cooperation and transparency of industry are critical in ensuring that violative products are 

promptly and effectively removed from the marketplace. FDA urges recalling firms to notify the 

Agency as soon as they determine a recall is appropriate. In addition, registered food facilities 

are required to report to FDA through the Reportable Food Registry when there is a reasonable 

probability that the use of, or exposure to, an article offood (applies to all FDA-regulated 

categories of food and feed, except dietary supplements and infant formula) will cause serious 

adverse health consequences or death to humans or animals. In many other cases, inspectional 

findings, sampling results, or other information in the Agency's possession leads to discussions 

with firms that can result in a firm's decision to recall a product. FDA typically asks firms to 

provide information to the Agency about the recall, including the reason for the recall, how the 

problem occurred, the extent of the problem, how and when the firm discovered the problem, 

where the product was distributed, and any consumer or supplier complaints. 

2 
28 


Recalling firms and FDA generally work collaboratively to develop a recall strategy or to review 

the firm's existing recall strategy. The recall strategy allows FDA to determine the steps it must 

take to address the specific circumstances, which may include making certain that all products 

that need to be recalled are, in fact, recalled; helping to locate the product subject to the recall; 

assisting to identify the cause of the problem; and checking associated firms or products to 

determine if the problem could be more widespread. FDA uses information it learns during 

recalls to help prevent future problems and to identify similar problems if they arise in the future. 

Throughout the course of the recall, it is the firm's responsibility to determine whether the recall 

is progressing satisfactorily by performing effectiveness checks. These checks help to verify that 

all known, affected consignees have received notification about a recall and have taken 

appropriate action. At the same time, FDA conducts "audit checks" to assess the effectiveness of 

a firm's recall efforts. 

Even though the firm recalling the product may publicize its recall, FDA will further publicize a 

recall when it believes the public needs to be alerted about a serious hazard. Notifying the news 

media is an effective way to inform large numbers of people that a widely distributed product has 

been recalled. FDA also provides notifications about all recalls of FDA-regulated products in its 

weekly FDA Enforcement Report. (See https:/!www.accessdatafda.gov/scripts!ires/index.cfm.) 

FDA WORK WITH FIRMS DURING RECALLS 

FDA is committed to working with recalling firms whenever possible to facilitate the orderly and 

prompt removal of a violative product from the marketplace, and has a variety of mechanisms in 

place to achieve this goal. FDA has field recall coordinators located throughout the country to act 

as the point of contact for a recalling firm and to assist firms with a recall. The recall 

coordinators provide a recalling firm with information about the recall process and are available 

to work closely with the firm throughout the course of the recall. For example, recall 

coordinators assist the firm in determining an appropriate recall strategy, review the recalling 

firm's notification letter to customers affected by the recall, and coordinate the appropriate 

destruction, reconditioning, or disposition of the recalled product. 

In addition, FDA has developed "model" press releases available for use by recalling firms that 

need to issue press releases to inform the public about a recall. These model press releases help 

ensure that all appropriate information about the recalled product is accurately and appropriately 

conveyed to the public. Further, FDA encourages recalling firms to consult with their local recall 

coordinators before issuing press releases. 

3 
29 


To assist firms in communicating their recall actions, and to help ensure that the public is 

informed, FDA posts firms' press releases on the Agency's website. FDA will also post photos 

of the recalled food product if provided by the firm. The use of product photographs for food 

recalls has also proven successful and useful to consumers. 

FDA'S COMMITMENT TO IMPROVING RECALL PROCESSES, DISCLOSURE, AND 

EXECUTION 

The recent OIG review of a judgmental sample of thirty food recalls initiated between 2012 and 

20 15 found some unacceptable delays in the removal of food from the market. As noted in the 

report, these were among the most complex recalls FDA deals with, and these recalls presented 

unique challenges, including: criminal behavior from a firm that hid critical information from the 

Agency; using new technology that links information from outbreaks to facilities; and putting 

information together from disparate sources to determine the appropriate expansion of a recall 

once an initial lot of contaminated food has been recalled. These are the types of challenges we 

are committed to addressing. Since the time period examined in this report, we have taken- and 

continue to take- OIG's recommendations seriously, and FDA leadership worked quickly to put 

in place measures to address the proposals that OIG outlined. 

One of the most significant steps FDA has taken was in April2016, by establishing a team of 

senior leaders charged with reviewing complex or unusual food safety situations and determining 

the proper action to address the problem if it is not clear. The team meets at least weekly and 

makes recommendations about what actions to take and how to make sure they occur. 

This team of senior leaders, called SCORE, which stands for "Strategic Coordinated Oversight 

of Recall Execution," has made a remarkable difference in addressing more complicated, 

challenging, or unusual incidents. SCORE has been involved in various disparate cases including 

lead contamination of a dietary supplement, Salmonella contamination of powdered milk, E. coli 

0157:H7 in soy nut butter, and Listeria in hummus, soft cheese, and smoked fish. In addition to 

facilitating recalls and import alerts for the detention of products entering the United States, 

SCORE initiated or helped to expedite the process for suspending the registration of two food 

facilities, actions that block the facilities' ability to distribute food to the marketplace. 

In addition to the establishment of SCORE, FDA has put in place several additional procedural 

and policy changes. Last year, after a comprehensive review of our recall process, we developed 

a new strategic plan that outlines actions to improve FDA's recall management. The plan helps 

to standardize how FDA assesses a company's recall efforts, establishes monitoring of the 

4 
30 


Agency's recall activities, provides additional training and guidance to our staff involved in 

recall efforts so they can properly monitor and assess the effectiveness of a recall, and increases 

the timeliness and amount of recall information provided to the public. 

The changes FDA has completed regarding its internal procedures since the OIG investigation 

include the following: 

• Established a monthly monitoring system that indicates to field personnel when a recall 

activity appears to be slower. 

• Completed a baseline audit of recalls in each district indicating the timeliness of each 

step throughout the recall process that provides a basis for field management to address 

untimely performance or challenges. 

Revised procedures to clarify when FDA may informally recommend that a firm cease 

distribution of, or recall a violative product to improve efficiency in processing cases. 

(See Regulatory Procedures Manual (RPM) 7-5-1.) 

• Updated FDA's Recall Audit Check Report and its instructions to ensure better 

documentation of recall audit checks, which is necessary to document the receipt of 

recalled product and notification of the recall, as well as the appropriate disposal of the 

product as instructed in the recall notification. (See IOM Exhibit 7-3.) 

• Expanded our third-party recall audit check contract to increase the number of recall 

audit checks performed. 

• Added fields in the Recall Enterprise System, FDA's internal recall database, to allow 

for more complete evaluation of recall time lines, including the Recall Determination 

Date, the Recall Audit Check Assignment Date, and the Recall Audit Check Completion 

Date to provide a greater ability to monitor open recalls to ensure that the recall is 

completed and terminated more promptly. 

• Created a central location and enhanced communications to foreign firms and 

governments to ensure that FDA initiates the oversight of recalls originally initiated by 

foreign suppliers. 

• Created a set of best practice recommendations for States to facilitate communication 

and coordination of recall activities in response to a Class I recall or a recall related to an 

outbreak. 

5 
31 


In addition to the list above, the Agency anticipates implementing additional revisions, 

procedural enhancements, and new policies that will continue to improve how we protect the 

public through the recall process and in our communications to consumers. 

FDA has also improved its recall classification process, speeding it up by enhancing our tracking 

of individual cases throughout the classification process, cross-training employees, and utilizing 

cross-trained employees during surge periods. As a result of a change that began in fiscal year 

2017, FDA now averages 13-15 days to classify food and cosmetic recalls from the recall 

recommendation, down from 79 days only a year earlier. FDA intends to continue efforts to 

further shorten this time period. 

IMPLICATIONS FOR FOOD RECALL PROCESSES FROM OTHER FDA CHANGE 

INITIATIVES 

FDA is also currently pursuing major initiatives that have implications for how the Agency 

oversees its recall functions into the future. Over the last several years, the Agency has been 

focused on finalizing and implementing FSMA, the most sweeping reform of food safety laws in 

almost 70 years, which shifts the focus of the U.S. food safety system from responding to 

contamination to preventing it. One of the preventative measures FSMA addresses concerns how 

firms conduct recalls. As part of the FSMA regulation on preventive controls for human food, 

where a hazard analysis identifies a need for a preventive control, the facility must have a written 

recall plan that includes procedures to notifY consignees, to notify the public when necessary, to 

conduct effectiveness checks, and to appropriately dispose of recalled product. In addition, FDA 

field operations in the Office of Regulatory Affairs have recently undergone a reorganization to 

meet the challenges of keeping pace with the scientific innovation, globalization, and increasing 

breadth and complexity of regulated products, as well as new legal authorities. With ORA's 

program alignment, FDA field staff now specialize in specific FDA-regulated product areas. 

Among the FDA field staff who have become specialized are the recall coordinators responsible 

for working with firms on food recalls, as noted above. These field staff are developing deeper 

knowledge of FDA's food safety standards, food inspections, and regulatory tools applicable to 

food, and a closer relationship with the Center for Food Safety and Applied Nutrition. 

CONCLUSION 

Thank you for the opportunity to discuss FDA's recall process. I would be happy to answer any 

questions you may have. 

6 
32 

Mr. HARPER. Thank you very much, Mr. Stearn, for your summary of your testimony. At this time, the Members will each have 

5 minutes to ask questions of you, and I’ll recognize myself for that 

purpose. And I’ll start with you, if I may, Mr. Stearn, to ask you 

some questions. 

The Office of Inspector General and the Government Accountability Office, in previous audit reports dating back to 2009, has 

raised concerns about the FDA’s monitoring of food recalls, such as 

verifying to make sure that retail grocery stores know about the recalls and the products have been removed from their shelves. Yet 

the December 2017 report from OIG finds that monitoring recalls 

is still a problem for FDA. 

Why is this still a problem? And why should the subcommittee 

believe that the FDA is going to get it right this time? 

Mr. STEARN. Thank you for your question, sir. I answer it a number of ways. First, I would say, we do take this issue seriously. I’ve 

outlined in my testimony today, and in greater form in my written 

testimony, a number of actions that we have already taken, and 

those included those that I just outlined in terms of establishing 

a group of senior leaders and audit process and additional procedures. 

I would say, too, that the oversight of the food safety system is 

a large-scale enterprise, and we are actively working on FSMA implementation, which is the overall solution that we think will bend 

this curve in terms of food safety, and it is something that we have 

been in great dialogue with with all of the other places in the food 

safety system. 

Mr. HARPER. I think it would be safe to say that a goal of FDA, 

through its implementation of FSMA, is to reduce the incidents of 

foodborne illness in the United States. Is that fair to say? 

Mr. STEARN. Yes, sir. 

Mr. HARPER. Is that FDA goal documented somewhere, and is 

there a timeframe? 

Mr. STEARN. Well, I think, in terms of the HHS initiatives and 

agency initiatives, there is language that speaks to that. I can say, 

as somebody who is involved in FSMA implementation myself—I 

am on the steering committee—it is something that we are driven 

to do, we have timeframes. At the same time, we think it’s really 

important to get things right. We don’t want to have to reverse 

back if we get a standard that’s not correct. And we are actively 

out implementing a lot of the provisions of FSMA, inspections have 

started in a number of areas, the rules have been written, and so 

forth. So we have a lot of actions that have been taken place. 

Mr. HARPER. Does the FDA view improvements to its food-recall 

process as part of achieving this public health goal? 

Mr. STEARN. We do. 

Mr. HARPER. And are you satisfied that you’re putting the 

metrics in place where we can actually do a quantitative view of 

what your improvement and process is going to be? 

Mr. STEARN. Yes, sir. We’ve taken a number of things to create 

more metrics and standards. We have an audit process in the steps 

that I’ve outlined which tracks during recalls the steps in between 

each of the, sort of, critical control points, each of the steps that 

take place, and we do think that that’s important. There’s always 

33 

more we can do, and some of these issues can be complicated, but 

we do think that that’s important. 

Mr. HARPER. I know that the public expects, you know, not to 

maybe do it that day, but the timeframe, that you’ve got to shrink 

that. Do you believe that you’re in the process to do that? To reduce greatly the number of days that it takes to complete this process when there is a recall? 

Mr. STEARN. We do. 

Mr. HARPER. OK. Ms. Jarmon, if I can ask you a few questions. 

What deficiency identified in the report does the HHS OIG view is 

the most serious, and why? 

Ms. JARMON. As you know, there were several deficiencies identified, but we feel like it’s so important that there’s better control 

over the oversight of firm’s initiation of food recalls, and that the 

health hazard evaluations are done sooner. We have several examples in our report where Health Hazard Evaluations weren’t done 

until, you know, in some cases over 100 days. I think, on average, 

57 days. And it’s so important that that’s done so that there’s better information that FDA would have about what the harm is of 

the products. We think that’s the most important. 

Mr. HARPER. The OIG report stated that this review was conducted to determine whether FDA is fulfilling its responsibility and 

safeguarding the Nation’s food supply now, now that it has the authority to conduct mandatory recalls. 

Does the OIG see any evidence that the mandatory recall authority has been helpful to FDA’s ability to carry out its mission to protect the U.S. food supply? 

Ms. JARMON. We are encouraged by the progress that FDA has 

made. We see that there has been progress, but definitely more 

needs to be done, and maybe more time because a lot of the things, 

like Mr. Stearn mentioned, have been recently done and we haven’t 

had an opportunity to go back and assess the progress. But the fact 

that the team was set up of senior executives, the SCORE team, 

is a positive step. The fact that there is a strategic plan now for 

recalls is positive. And the fact that they have the audit plan, as 

Mr. Stearn mentioned, is also positive, and that yesterday they 

issued draft guidance for improving the recall process. And all of 

those things could possibly be related to this legislation, so we see 

it as steps in the right direction. 

Mr. HARPER. That’s right. Thank you very much for your testimony there. The Chair will now recognize Ranking Member 

DeGette for 5 minutes. 

Ms. DEGETTE. Thank you, Mr. Chairman. Ms. Jarmon, I’m encouraged to hear you say that—and Mr. Stearn, I also believe it’s 

true that the FDA is making efforts to improve their systems. The 

OIG’s recommendations largely relate to the FDA improving its 

policies, procedures, and guidance. Do you agree with that? 

Ms. JARMON. Yes. Many of them do relate to improving their 

policies and procedures and guidance, and initiating the processes 

sooner. We mentioned long delays. 

Ms. DEGETTE. OK. So I’m wondering, what more actionable steps 

do you think FDA should take to improve its recalls in addition to 

just improving the policies and procedures? You mentioned initiating the guidance sooner. Can you expand on that? 

34 

Ms. JARMON. Yes. I mentioned doing the Health Hazard Evaluations sooner, because in our report, one of the examples that the 

chairman mentioned earlier about the issue that we mentioned in 

our Early Alert from June 2016, one related to a cheese product 

and one related to nut butter for the period of time from the time 

that FDA became aware of the hazardous product in a time that 

the firm initiated the recall, and that’s just the initiation, more has 

to happen after that to get the products off the shelf. 

Ms. DEGETTE. Right. 

Ms. JARMON. For the nut better, that was 165 days. For the 

cheese, it was 81 days. In that period of time, while we aren’t specifically saying in our recommendations what the period of time 

should be, we believe it’s reasonable to expect less time than that. 

Ms. DEGETTE. The reason is, because if the food is contaminated, 

more people could be consuming it during that time. That is what 

Chairman Walden was talking about. 

Ms. JARMON. Yes. And more illnesses and possible deaths. 

Ms. DEGETTE. Yes. Mr. Stearn, what’s the agency’s response to 

this? 

Mr. STEARN. Well, I would say a couple of things. First, as I’ve 

outlined, we’ve changed a number of our procedures and policies. 

I will say, one of the issues underneath here is to make sure that 

a problem is understood and that a recall actually is solving the 

problem. 

The cheese recall that was mentioned, there were actually four 

different recall actions that took place during the course of that. 

So, you know, part of the question that gets to, you know, what action is taken, is that sufficient? One of the reasons that we put 

SCORE in place—and we feel that that’s really critical, and also, 

the specialization of the field staff, which has been going on for 

years—is that it’s important for people to have the technical expertise to make those judgments, and sometimes to order additional 

investigation because—— 

Ms. DEGETTE. Are you having difficulty getting people with the 

appropriate expertise? 

Mr. STEARN. Well, we’ve got to make sure that they’re at the 

table, and it gets more complicated. I mean, one of the things that 

happened during this period of time—in the nut butter recall, we 

started, for the first time, doing an entirely new technology, which 

is whole genome sequencing. We need people to understand that. 

We need people to understand, you know, the rules that have 

been mentioned in FSMA. And so the level of specialization and the 

level of understanding of the supply chain needs to be high. 

Ms. DEGETTE. I get it. 

Mr. STEARN. Yes. 

Ms. DEGETTE. Are you having difficulty attracting those people? 

Mr. STEARN. Well—— 

Ms. DEGETTE. Yes or no will work. 

Mr. STEARN. We have a number of great people in the agency, 

we’re always looking for more. 

Ms. DEGETTE. Would having a stable budget help in that situation? 

Mr. STEARN. A stable budget is helpful. 

35 

Ms. DEGETTE. OK. So one issue that, as I recall—we really 

talked a lot about before we passed the Act—was this issue of mandatory versus voluntary recall. And I’m wondering if you’re finding, 

because the agency has the ability to implement mandatory recall, 

if that’s helping expedite the voluntary recall process more? 

Mr. STEARN. We believe it is helpful for certain categories because there’s a certain point where we reach with a firm in our discussions, and the firm knowing that that power is there, does affect 

the result. 

Ms. DEGETTE. And have you noticed, since the Act passed, the 

number of mandatory recalls have gone up? 

Mr. STEARN. Well, what often happens, more often than not, it 

reaches this certain point and there is a voluntary recall. And, you 

know, a lot of the—so we do think that it has an impact by being 

there, and it’s usually in firms taking a voluntary recall, either because there’s a mandatory authority or because they know that 

there might be a communication from the agency. You know, those 

two things are actually drivers in the self-interest. 

Ms. DEGETTE. Nudging them along. 

Mr. STEARN. Yes. 

Ms. DEGETTE. So, you know, I really appreciate the OIG’s recommendations, and I appreciate the agency’s implementing them. 

If you think that there’s more authority this committee needs to 

give to the agency to bolster that, and if you think there’s more resources or stability of resources to do this hiring, let us know, because we—this is one of these bipartisan issues. We care deeply 

about the safety of our constituents. Thank you. I yield back. 

Mr. STEARN. Thank you. 

Mr. HARPER. The gentlelady yields back. The Chair will now recognize the vice chairman of the subcommittee, Mr. Griffith, for 5 

minutes. 

Mr. GRIFFITH. Thank you very much, Mr. Chairman. Mr. Stearn, 

I know you’re here doing the best you can and that you’re trying 

to make everything better, but there’s some real serious questions 

that I have related to a number of different things, but I’m going 

to start with the nut butter situation, because we just touched on 

a couple of those. 

One, you were talking about having the mandatory authority. If 

you look at the timeframe, which is Attachment A in the OIG report, if you look at the timetable there on their chart—it’s page 30 

of what I have, but you may have something different—you all exercised or let them know that you might use mandatory on August 

15th, and they voluntarily recalled on August 19th. So I think in 

response to Ms. DeGette’s question, it clearly works because you 

told them you were about to do it, and 4 days later, they were, like, 

‘‘OK, OK, we’ll do it voluntarily.’’ 

The problem I have is on two things that you said also in that 

regard. You said that part of the problem was the new technology, 

the whole genome sequencing. But when you look at the time 

chart, it raises all kinds of questions for me. So I want you to explain the whole genome in a minute. 

Mr. STEARN. All right. 

Mr. GRIFFITH. But here is the question that I have. There was 

enough information that something was going on that you all 

36 

opened up an investigation in February—late February, 6 weeks 

later, you actually, under using the older technology, matched an 

uncommon strain of Salmonella to that facility. That was on March 

24th. And connected it with some of the folks who had gotten sick. 

Nothing was done, apparently, at that point, there may have 

been some letters, I don’t know. But then, the whole genome sequencing was completed on May 12th. So the discussion that you 

want to make sure you’re doing the right thing and not disrupting, 

as Ms. DeGette said earlier, an entire industry with a recall that 

is not justified—you had that confirmation on May 12th. So May 

12th, June 12th, July 12th, August 12th, all went by, eventually 

3 months and a few days later you then threatened the mandatory 

recall. 

Mr. STEARN. Right. 

Mr. GRIFFITH. So the question is, the American people who are 

watching this, either live or later when they are having insomnia, 

are going to ask is, OK, we want to make sure we’re doing the 

right thing. Maybe you can justify, although there’s a question 

mark there between March 24th and May 12th. But once you’ve got 

the whole genome sequencing, and there’s no distinguishing between the Salmonella in the sick people and in your environmental, 

and I know I’m not using the scientific terms, but the sick people 

and in the nut butter, why didn’t you act then? 

Mr. STEARN. So there’s a number of issues that make this complicated, if I can go back a little bit. 

Mr. GRIFFITH. OK. 

Mr. STEARN. So there was a link under the PFGE pattern in 

March of 2014. It’s important to understand that a couple of 

things—— 

Mr. GRIFFITH. All right now, folks back home don’t know because—what is PFGE—— 

Mr. STEARN. This is pulsed-field gel electrophoresis. It helps link 

the clinical, that is, from the person, to what’s happening at the facility. 

Mr. GRIFFITH. Right. 

Mr. STEARN. It’s something that we used—been relying on for a 

while. It’s not perfect, because it’s more limited in the amount of 

information that—in terms of comparison of those organisms. And 

it shows that there’s a strong link between what those organisms 

actually are, because something like, you know—— 

Mr. GRIFFITH. And that’s what you linked up in March? 

Mr. STEARN. That is what we linked up in March. I will tell you 

that our expert analysis is that was not enough to show causation 

at that point. 

Mr. GRIFFITH. OK. 

Mr. STEARN. There was no link. And it was done differently than 

we usually do it. Usually there’s a food history that links—where 

they ask people, what did you eat? And they link that back. Then 

we look at the PFGE. That didn’t happen in this case. People did 

something new in this case. They went through some of the data 

bank, and they linked that up. They linked it up with PFGE, and 

they linked it up with whole genome sequencing. They’re very excited about that when that happened, because it does—and it actually has been something that we used that is linking up to this 

37 

database, and it’s something that really is very promising. But 

there were delays in this case, and I should say, first of all, I think 

we have done better in this case. 

I will tell you that when we did the whole genome sequencing, 

we did it for the environmentals in May. It was not until August 

that we linked it to the clinicals. And that was a delay in terms 

of doing that whole genome sequencing link, which was the trigger 

for that, you know, request for mandatory recall and the discussions with the firm that resulted in recall. 

There were things that I think could have been done differently 

in this case, but I do think it’s important to understand some of 

the complexities. This was not an obvious case on day one, and in 

fact, in a number of these cases, it’s not obvious on day one. It’s 

very important that we accelerate our own investigation. It’s important that firms have their own investigation and their own preventative models. 

But it was less than clear to the people who had that, you know, 

back in March because there were environmentals which were concerning, but the links to the clinicals were less than crystal clear. 

Like I said, it wasn’t supported at that time by the food histories. 

And the firm tested all their products, all the products were negative. So, you know, the firm testing was—the firm was pushing 

back on us with some of their own testing. 

The story’s a little bit more complicated, but at the same time, 

we take the OIG’s point in this, and we agree with it. We need to 

make sure this is—it’s not OK if it takes this long, even if it’s complicated. That’s why we have this approach in place where we feel 

we need to make sure that the agency leadership and the staff are 

prepared to, you know, know what’s a red flag and act on it to 

make sure we get to the right result as soon as possible. 

Mr. GRIFFITH. I appreciate it and yield back. 

Mr. HARPER. The gentleman yields back. The Chair will now recognize the gentlemen from New York, Mr. Tonko, for 5 minutes. 

Mr. TONKO. Thank you, Mr. Chair. This committee has repeatedly heard that FDA must manage food recalls more effectively. 

That is why Congress gave FDA new authorities under FSMA in 

2011. FDA has told us that it’s taking steps to improve that recall 

process. However, the OIG’s report finds that FDA’s data on food 

recall is often incomplete or inaccurate, which makes it difficult, if 

not impossible, to tell how things have improved since Congress 

gave the FDA new tools. 

For instance, FDA’s recall data system does not track key milestones, such as the date that FDA learned that a product was potentially hazardous. 

So, Ms. Jarmon, can you offer some insight about why those data 

are important and how incomplete data make it difficult for FDA 

to manage food recalls? 

Ms. JARMON. Yes. It’s very important that the data in their recall 

systems is complete and accurate. That way, they can—that’s key 

to monitoring the food recalls. And like we mentioned in our report, 

there was no data in there for when FDA became aware that an 

item was potentially hazardous. 

And so in some cases—so without having that date there, it’s not 

possible for them to determine how long it took them from the time 

38 

they became aware that the product was potentially hazardous 

until the time that the food-recall initiation occurred. And in some 

cases, some of the longer examples that we have, like one, which 

was a dietary supplement, where it was 303 days from the date 

that FDA became aware that their product was hazardous, and actually sent a warning letter to the firm, it was 303 days later 

when, in that case, the food-recall initiation occurred because that 

date wasn’t in the system. If you look at FDA system, it was 10 

days based on—because the dates in the system were not correct. 

Mr. TONKO. Uh-huh. 

Ms. JARMON. So it’s very important to make sure that the action 

is happening faster. 

Mr. TONKO. Right. And I thank you for that. And OIG points out 

that because FDA doesn’t record the date when it learns a product 

is potentially hazardous, FDA couldn’t determine, for instance, that 

it took a firm 151 days to actually initiate a recall of hazelnuts contaminated with Salmonella. FDA claims that it would be time consuming to track this information. 

Mr. Stearn, if FDA does not track milestones like this, how can 

you tell when firms are not moving swiftly enough to remove dangerous foods and when to take more aggressive action? 

Mr. STEARN. Thank you for your question, sir. We do think it’s 

important for the agency to record when there’s a critical hazardous step. There are a number of issues in terms of our systems 

and how they interlink. We have different systems for different 

purposes and what kind of information that can be in there. We 

take this point, we’re looking at trying to make sure that our procedures clarify and make sure that the records are correct when it 

has tipped over. And we’re going to continue to work on that. 

Mr. TONKO. Thank you. In addition to incomplete data, OIG also 

found that FDA did not always collect timely and complete status 

reports from firms during a recall. 

Ms. Jarmon, does that hinder FDA’s efforts to oversee the recalls, 

and how so? 

Ms. JARMON. Yes, because it’s important when—after the firm 

initiates the recall that the FDA is also monitoring what’s happening after that period of time, so that, of course, when the initiation first started, the products are still on the shelf. So in many 

cases, the firm is still testing effectiveness and verifying different 

things related to the product. And we found, in some cases, the status reports weren’t received over 100 days until after this process— 

the firm had been communicating their story, the recall. 

So it’s important that FDA continues to check on this status and 

monitor the firms when they’re in the recall process, and the status 

report is one way to do that. 

Mr. TONKO. Thank you. And, Mr. Stearn, does FDA agree that 

it needs to improve its collection of these status reports? If so, what 

steps do you think we should take? 

Mr. STEARN. Yes, it would be—well, let me say first that we 

would like to have better status reports. It is entirely a voluntary 

process, so—it’s right now and historically, and during this time, 

there’s no obligation for a firm to provide us status reports. And 

we do think that that will be improved through the implementation 

of the preventative control rule, which requires firms to have recall 

39 

plans. And so for the first time, FDA—there will be an obligation 

in terms of how they conduct their recalls. 

Third-party audits for recall audit checks we think are critical. 

We did have an extended discussion with OIG about that. We have 

expanded that program. That gives us a lot more flexibility, and it 

turns around our recall audit check process much faster. And we 

do think consumer notices are appropriate because it sort of jumps 

over the whole recall system and gets the message to where it 

needs to be. 

Mr. TONKO. Thank you very much. Mr. Chair, I yield back. 

Mr. HARPER. The gentleman yields back. The Chair will now recognize the gentlelady from Indiana, the distinguished chair of the 

Ethics Committee, Mrs. Brooks, for 5 minutes. 

Mrs. BROOKS. Thank you, Mr. Chairman. And thank you and the 

ranking member for holding this important oversight hearing 

today. As the committee is well aware, biodefense issues are something that I’ve been working on. Public health securities is a top 

priority as we look at how we oversee our food supply. It’s a security issue as well as to how it impacts a threat to our food system, 

that can be devastating. Much of our Nation’s corn, soy, and hog 

supply comes from my State of Indiana. And I know and believe 

that our Nation needs a stronger system of monitoring animal 

health, both for the threats to our Nation’s food supply, but also 

for potential outbreaks in the animal population that can mutate 

and jump to humans. 

And should a bad actor seek to affect our food supply, our system 

I’m not certain is equipped to quickly determine if it’s a foodborne 

illness naturally occurring or if it is manmade. And in the case of 

a bioterror attack, obviously, timely response is crucial but I know 

can be difficult. 

So with that, Mr. Stearn, I’m interested in FDA’s efforts to protect the U.S. food supply from bioterrorism or economically motivated adulteration, and what steps has the working group on economically motivated adulteration taken to improve protection of 

our food supply? And, more directly, so how would FDA, as we’re 

talking about these types of food recalls coming from manufacturers, but how would FDA respond if there could possibly be a terrorist attack? 

Mr. STEARN. Thank you, Ms. Brooks. There are a number of 

points I would make. First, there is, as part of FSMA, there’s an 

intentional adulteration rule in which firms are to look at their 

own risks related to potential intentional adulteration from other 

parties. So there’s one component. 

We do have a food defense group within FDA that monitors some 

of the intelligence and works with some of the intelligence to try 

to make sure that we’re able to monitor what’s coming in from outside of the country, largely, in terms of food defense. And we also 

believe that, you know, having a preventative food safety system 

generally allows for closer monitoring of what’s coming in and making sure that folks understand what’s happening in their own supply chains. And that’s the kind of danger that we’ve seen in some 

of these incidents that have happened historically, is that sometimes there’s something that happens in a supply chain, and it’s 

brought into the United States, and then we have an issue. 

40 

And the system that’s being created within FSMA helps to have 

people monitor what’s happening throughout the supply chain, 

which is, in part, also helpful to combat those issues. 

Mrs. BROOKS. I appreciate that, but now this is as of December 

2016, and here we are January 2018, the FDA—as of December 

2016, so I’m curious if something has changed—the FDA still 

hadn’t met a 2011 GAO recommendation to provide written advice 

to centers and offices on avenues to address economic adulteration. 

Has that changed? Has the FDA created a document that’s been 

used to meet GAO’s recommendation from 2011? 

Mr. STEARN. I think—I’m not aware of such a document. I do 

know that there was a group that looked at this issue, and they 

found it very challenging. I’ve spent some of my career at FDA 

looking at the heparin issue for several years. I worked with the 

committee on that. And there are a lot of different ways that this 

could happen. So I think, in large part, the answer that the agency 

is looking for is to look at standards that get applied throughout 

the supply chain, because the places that we’ve seen this enter, the 

places we’ve seen economically adulterated products coming in, it 

is usually where there is a lack of accountability within the supply 

chain, and that’s what we think is sort of the most effective strategy. 

Mrs. BROOKS. And you indicate that there are a lot of, obviously, 

strengthening our systems against bioterror, are incredibly complex, but can you talk with us about some of the impediments and 

challenges that your group and those who work in that group are 

experiencing, so we can help break down those impediments? 

Mr. STEARN. Coordination of intelligence can be a challenge. We 

do have a group that works with CBP at their counterterrorism 

center. And I would just say, just generally, that’s an issue, because a lot of coordination that needs to happen, and because it is 

secure information that can be a challenge. 

Mrs. BROOKS. I know, but we’ve been working on that since 9/ 

11. And it is now 16 years later. And so you’re saying that there’s 

still a challenge with your agency working with CBP on the supply 

chain? 

Mr. STEARN. What I would say is one of the issues that we deal 

with is to try to make sure the intelligence is where it needs to be. 

I’m not prepared to go probably any deeper than that at this point. 

I would say also the intentional adulteration rule is something that 

the agency has come out recently that does address that issue. 

Mrs. BROOKS. Thank you. 

I yield back. My time is up. 

Mr. HARPER. The gentlelady yields back. The Chair will now recognize the gentlelady from Florida, Ms. Castor, for 5 minutes. 

Ms. CASTOR. Well, thank you, Mr. Chairman and Ranking Member DeGette, for calling the hearing today. And thank you to our 

witnesses for the work that you’re doing. 

The issues we’re talking about today have serious real-world consequences, as a single contaminated food product can have devastating impacts across the country, depending on what it is and 

how it spreads. As an example, the OIG report cited a 2014 recall 

of cheese products contaminated with Listeria. That product conVerDate Mar 15 2010 11:46 Jan 08, 2019 Jkt 037690 PO 00000 Frm 00044 Fmt 6633 Sfmt 6633 I:\115THCONGRESS\115X93FDARECALLSAWAITSTEARNQFRR\115X93FDARECALLSPD
41 

tamination is particularly troubling because it led to one infant’s 

death and two lost pregnancies. 

According to OIG, 81 days elapsed it between FDA becoming 

aware of the adulterated product and the firm recalling all of the 

affected products. I understand that this case is particularly complex and FDA was even given misleading information from the 

firm. But I’d like to walk through this recall and try to shed some 

light on the lessons learned. 

Mr. Stearn, FDA learned about the contamination on July 28th, 

then spent a month inspecting, testing samples, and requesting an 

update from the firm. You had previously mentioned that it’s always important that FDA accelerate its recalls. Could you give 

greater detail on this case? How could FDA have shortened that 

phase of the recall? 

Mr. STEARN. One thing I would point out, there were a number 

of different recall actions that took place. There were actually four 

different recall actions that the firm took, that Oasis took during 

the course of this time period that was referenced. The first was 

after—there was a positive sample where one of the firm’s cheese 

products, and in less than a week, there was a recall of that particular product. And then, also, FDA initiated an inspection of the 

facility. So we did act quickly to follow up with that. 

During the course of that inspection, there were environmental 

samples that were positive. We went in and did a lot of sampling 

in the firm. There were a number of things that were positive, and 

there was a frank discussion with the firm. After that, the firm 

made a series of promises. The firm actually—well, first, the firm 

said they would stop manufacturing. The firm also said that they 

would stop distribution until they had consulted with FDA. And 

the firm said that they would bring in an expert and to do additional testing. And the firm also committed to do a recall of some 

product—which they did initiate—that was implicated by the environmental testing positives. And so, you know, that happened. And 

then after that, the firm continued to manufacture at a certain 

point and did distribution. 

Ms. CASTOR. I also understand that, after FDA conducted its 

test, it received a brief letter from the firm on September 11th that 

reportedly ‘‘lacked significant supporting documentation.’’ But then 

the firm, as you said, distributed potentially adulterated products 

after that, but then FDA didn’t conduct another follow-up inspection until nearly a month later. Why didn’t FDA take swifter action 

after receiving the response from the firm on September 11th? 

Mr. STEARN. FDA believed the firm was not manufacturing at 

that time, based on what they said, and not distributing. I think 

that—I say that, at the same time, I say I think there’s more that 

FDA should have done in this case. And in some respects, it gets 

to the issue of a preventative mindset versus reacting. 

Ms. CASTOR. Because when FDA conducted its follow-up inspection on October 7th, it, again, found the presence of Listeria. And 

at this point, this was 45 days after FDA first learned about the 

contamination. However, it took the firm another 10 days before it 

voluntarily recalled all the potentially contaminated products. So at 

this point, what could FDA have done differently to either encourage or mandate a faster and fuller recall? 

42 

Mr. STEARN. So one of the things—and this gets back to you how 

some of these things can be complicated. The firm did act when 

FDA brought some sort of positive sample to it. They acted, they 

initially did a recall related to the first product sample. After there 

was an environmental, the firm made a series of promises which 

turned out to be lies, they were false. And we didn’t find out fully 

about that until going back on inspection. But, you know, the firm 

said a lot of things that would be the kinds of things that FDA 

would want to hear: ‘‘We’re going to stop manufacturing——’’ 

Ms. CASTOR. So if they are not truthful with you or they don’t 

follow through, how do we hold them accountable? 

Mr. STEARN. I would say a couple of things. First, it is important 

always to verify, even this firm’s recall activities should have been 

broader, there should have been a broader recall earlier. We had 

a product sample positive. We had environmental samples. We had 

bad practices that were documented in the firm. That is a pretty 

strong set. The firm made a lot of promises. The firm, I think, even 

given that, more should have occurred. 

Ms. CASTOR. But the accountability answered. 

Mr. STEARN. So in terms of it—one thing I would note is that the 

owner was prosecuted. FDA does have an office of criminal investigation, so that, I think, the deterrent message is important. And 

also, we need to verify. I mean one of the reasons, and OIG mentioned about recall audit checks and whatnot, it is very important 

that we do those to make sure those things happen. It is important 

that we have follow-up inspections to make sure what was promised gets done. So FDA has verification procedures it needs to use. 

And if it is a high-risk issue, like this one, we need to use them 

quickly. 

Ms. CASTOR. Thank you. I yield back. 

Mr. HARPER. The gentlelady yields back. The Chair will now recognize the gentleman from New York, Mr. Collins, for 5 minutes. 

Mr. COLLINS. Yes. I thank the chairman and the witnesses. Certainly, food safety is a universal concern, and this is not a partisan 

hearing at all. We’re genuinely trying to get to an understanding 

of what does happen. 

So let me back off just a little. We say there’s about 3,000 recalls 

a year, about 10 a day. Roughly how many of those are voluntary 

firm-initiated, and how many of those would be, you know, mandatory recalls driven by the FDA? 

Mr. STEARN. Virtually all are voluntary. 

Mr. COLLINS. That’s what I would expect. In the threat, certainly, the mandatory is there. So since these are voluntary, whether it is under pressure or not, how quickly does the FDA classify 

those as a class 1, 2, or 3? 

Mr. STEARN. So I think OIG referenced some of the earlier data, 

most recently we were doing that within 13 to 15 days in the food 

program. 

Mr. COLLINS. And I’m assuming that, if it is class 1, you know, 

that’s when somebody’s hitting the buzzer with the red lights and 

so forth, that you do a lot more detailed work, analysis, urgency 

for a class 1. 

Mr. STEARN. It is a red flag. 

43 

Mr. COLLINS. So roughly, how many class 1’s a year do we get 

versus 2 or 3? 

Mr. STEARN. I think it is in my written testimony. I would have 

to get back to you with the exact number. 

Mr. COLLINS. But, I mean, is it 10 percent or 80 percent class 

1? 

Mr. STEARN. It’s in between those two. So I don’t have the exact 

number. But I’d hesitate to give a number when I’m not sure, but 

it is in between those. So there is a significant proportion, but it 

is not the majority. 

Mr. COLLINS. So if it was 20 percent, that would be two a day, 

roughly? 

Now do you have the staff that, you know, is one person given 

oversight of that particular recall? You’ve got two every day that 

is class 1 voluntary recalls. Is that a team that goes to work, or 

a single person, or—— 

Mr. STEARN. We have recall coordinators that are throughout the 

country. One of things that we’ve done in our recent reorganization 

is we specialized that staff. So there are recall coordinators who 

interact with the firms. There are also other components that do 

other things that are related to recalls. But a lot of that is run by 

our field staff locally. 

Mr. COLLINS. So your inspectors are in these facilities every day? 

Mr. STEARN. Yes. 

Mr. COLLINS. Sometimes they literally have offices there. 

Mr. STEARN. Yes. 

Mr. COLLINS. And so we have to rely on the professional nature 

of the company itself. I’m thinking of the quality manual. You, I’m 

sure, are always reviewing the quality manuals. As you said, 

though, I was a little disturbed to see you don’t currently mandate 

a recall procedure or plan? With each company that you reduce, 

your inspectors are not auditing recall plans today? 

Mr. STEARN. Well, right now, recall plans—well, before the passage of FSMA and the implementation of preventative control rule, 

there was not any kind of mandate that a firm have a recall plan. 

Mr. COLLINS. That would be a concern. 

Mr. STEARN. So I will say when there is a recall, traditionally we 

will follow up, and that happened in these very cases, other cases 

that have traditionally happened where there is a recall. We do follow up with that on inspection, ordinarily in the next inspection to 

make sure, and we try to do that quickly to make sure that there’s 

some review of what occurred. 

The difference is, what’s the, you know, legal requirement, what 

standard do they have to do? I mean, we were talking about status 

reports. Do they have to do status reports? What do they have to 

do in a recall? FSMA helps standardize that. The firm has to plan, 

where there is a hazard, to make sure there’s some kind of plan 

to address recalls, in particular. Whereas before, it was more reactive. 

Mr. COLLINS. I mean, common sense, if you don’t have a plan, 

then it truly would be haphazard at best. So I would hope your inspectors who are in there every day are constantly making sure 

that T’s are being crossed, the I’s dotted. 

44 

Mr. STEARN. Thank you, Congressman. Related to your earlier 

question, I got a note. So we are about 1,200 products class 1 out 

of a little bit more than 3,600, so that’s roughly a third. 

Mr. COLLINS. That’s actually higher than I might have expected. 

Now, how often—I only have a few seconds left—does your lab 

do independent testing, or your labs versus relying on the company 

data to assess the risk? 

Mr. STEARN. So we do part of the things that you mentioned in 

some of these where we have a class—it’s where there’s a certain 

risk profile. If it hits a certain risk profile, we will do testing in 

the environment of that facility. In addition, if we have reason to, 

we have different types of surveillance testing. We have it at import and we have it in a domestic realm, and those all go off to our 

labs. So we do a lot of testing ourselves. Firms also have their own 

testing programs. 

Mr. COLLINS. Which you rely on, as well? 

Mr. STEARN. That is part of our oversight, is to look at what they 

are doing. 

Mr. COLLINS. My time’s expired. I appreciate your answers. I 

yield back, Mr. Chairman. 

Mr. HARPER. The gentleman yields back. The Chair will now recognize the gentleman from Pennsylvania, Mr. Costello, for 5 minutes. 

Mr. COSTELLO. Thank you, Mr. Chairman. 

Mr. Stern, as you know, the OIG report identified a number of 

deficiencies in the food-recall process. And I wanted to direct your 

attention to figure 1 that shows the days it took firms to initiate 

the recall after FDA learned a product was potentially hazardous, 

with specific reference to the new trucks research incident where 

it took 303 days to execute a recall after the warning letter was 

issued. 

First, is it correct that in this particular case, it was found the 

firm continued passing out free samples after receiving their letter? 

Mr. STEARN. I’m unsure about that specific fact. 

Mr. COSTELLO. Is that easily obtainable for you to provide us in 

short order? 

Mr. STEARN. I could. 

Mr. COSTELLO. I appreciate that. 

Are FDA actions, after a warning letter, typically delayed for 300 

days? 

Mr. STEARN. No. 

Mr. COSTELLO. How often, on average, or is it customary or within the realm of accessibility, for the FDA to take an enforcement 

action after issuing a warning letter? What’s the typical—— 

Mr. STEARN. There’s some variation by program, I would say ordinarily we go back within 6 months. In certain areas, clinical 

trials, for example, it tends to be longer because there has to be 

enough data to actually monitor what has occurred, but this is not 

what ordinarily happens or what we should expect. 

Mr. COSTELLO. Are the delays of a recall more of a problem with 

dietary supplement products? 

Mr. STEARN. I would say there are—this is a good—one of the 

issues that occurred here in these dietary supplements, there’s an 

ingredient, DMAA. There’s some controversy about that. There has 

45 

been some litigation related to that. And I could follow up with you 

in some ways, but I would just say where some of the issues are 

scientifically challenging, the firm did challenge some of the science 

about the safety of the ingredient in this case. 

Mr. COSTELLO. And then, final question on this line of thought: 

What lessons can you share that you’ve learned from the new 

trucks research case? 

Mr. STEARN. I would say overall, you know, in terms of the lessons, I think we would say it’s important for the agency leadership 

to look very closely, especially at high priority things that we’ve 

had at class 1, that is the kinds of things that have the highest 

risk. We need to do that prioritization, and we need to investigate, 

and we need to make sure that we have systems in place to act 

when that occurs. 

Mr. COSTELLO. Were systems in place at that time and were not 

followed, or were the systems incomplete or insufficient? 

Mr. STEARN. I think in this case, one of the issues that was related to the fact that this is not—the safety of DMAA, or the 

unsafety of DMAA, which the ingredient at issue there, is not—I 

will just say there’s a controversy or different ideas about that. 

And, you know, to some extent, we have to resolve that sometimes 

in the court system. 

Mr. COSTELLO. To the extent that a warning letter triggers the 

type of litigious activity surrounding the safety of a particular element, does that give it higher priority or does that add to the priority, or is that something within the systems that you have to address? 

Mr. STEARN. I think we need to prioritize. And your question is 

a fair one. If we have—there are a number of warning letters that 

come out. The agency has a lot of different issues. If it’s an issue 

that we find to be one that has potential harm to consumers, it’s 

a higher risk issue, we should make sure that that gets addressed. 

Mr. COSTELLO. Yes, because it strikes me that—I didn’t do this 

kind of work as an attorney, but if you were a GC for a company, 

if you have a product on the market, the product is doing well, you 

get an FDA letter that says, ‘‘This is a warning letter,’’ et cetera, 

et cetera, et cetera. Number one, I don’t think a company—I 

wouldn’t think many companies would put a product on the market 

that they felt was deadly or that would trigger that first tier—well, 

any tier, but particularly, that first tier. The question becomes, it 

is pretty reasonable or expectant to assume that you’re going to get 

a response that says, ‘‘Wrong, we’re going to take you to court’’ or 

‘‘This issue is going to be litigated.’’ And that should not freeze you 

up in terms of addressing what you identified as a potential health 

issue. So how—— 

Mr. STEARN. I would agree. 

Mr. COSTELLO. What do you do about that? 

Mr. STEARN. We need to make—again, I think, as is the kind of 

issue that you flagged, there may be disagreement. If it’s something that the agency finds is a threat to consumers, we have to 

prioritize that, and we need to make sure that we bring it forward. 

Mr. COSTELLO. Do you have sufficiently expansive regulatory authority in order to do that, or do you need statutory assistance? 

Mr. STEARN. We are not asking for any authorities today. 

46 

Mr. COSTELLO. Very good. I appreciate your answers. 

I yield back. 

Mr. HARPER. The gentleman yields back. The Chair will now recognize the gentlelady from Illinois, Ms. Schakowsky, for 5 minutes. 

Ms. SCHAKOWSKY. Thank you. I want to focus on FDA’s mandatory recall authority. So the OIG’s report describes some concerning 

contamination cases, and unfortunately it is not the first time we’re 

hearing about such outbreaks. In fact, this committee has been investigating FDA’s food safety efforts and recall practices for well 

over a decade. 

Over 7 years ago, FDA told the subcommittee that mandatory recall authority would help it remove dangerous products from the 

market more quickly. Congress then passed the FDA Food Safety 

Modernization Act, FSMA, which gave FDA this very authority and 

significantly reformed the agency’s ability to prevent and respond 

to outbreaks. Now we are here again discussing these issues. So I 

want to find out how this law is working. 

Mr. Stearn, overall, has FSMA helped FDA oversee food recalls, 

particularly regarding inspection resources. 

Mr. STEARN. Yes. 

Ms. SCHAKOWSKY. So you have had enough resources in order to 

do the job? 

Mr. STEARN. I believe we have enough resources within the—— 

Ms. SCHAKOWSKY. Here is then—Congress gave FDA this authority to help the agency respond to contaminated foods faster. However, the OIG reported that, between 2011 and 2016, FDA used 

that authority just twice. And just yesterday Commissioner Gottlieb stated, and I quote, ‘‘recall authorities and how we deploy 

them are a cornerstone of our vital consumer protection mission.’’ 

So Mr. Stearn, given that your recall authority is the cornerstone 

of the agency’s consumer protection mission, can you explain why 

FDA has only used its mandatory recall authority twice, or a few 

times, anyway? 

Mr. STEARN. Thank you for your question. 

First, I would say our goal is to remove the product from the 

marketplace if it’s unsafe—that we start with that as a precept. 

And, ordinarily, if a company is willing to do that, that’s going to 

be the fastest way to make sure that that gets done. 

Now we have a number of, as I mentioned earlier, we do think 

that mandatory recall is one of the things that when we get to a 

certain stage with a company, generally convinces that company to 

recall, if it’s the right thing, that it does play a role in the background in our discussions as well as some of the consumer communications that the agency uses. So I would say that’s really one of 

the things in the background, which is also to say there may be 

cases where it’s appropriate and we should be using it if other actions aren’t happening quickly enough. 

Ms. SCHAKOWSKY. So the FDA has to meet certain standards before it can invoke the mandatory recall authority. Is that correct? 

Mr. STEARN. That’s correct. 

Ms. SCHAKOWSKY. So are there difficulties in meeting that standard, or do you feel that having it there as threat is sufficient? Is 

that what you’re saying? 

47 

Mr. STEARN. Well, what I would say is a lot of issues get into 

the facts, there are some complexities about identification of products sometimes and the level of hazard within products. We ordinarily don’t have issues with firms when there is a pathogen in a 

particular lot of the product. A lot of the times that we have issues 

is, what about the other products made at that facility? That happened actually in the cheese recall we mentioned earlier. And what 

level of evidence is needed for that. So sometimes there is a question, a scientific or factual question about identification, the level 

of risk, and so forth. 

And so those are things that I think—again, back to why we 

have reacted to the OIG’s report the way that we have is that our 

centerpiece really is core, our centerpiece is to make sure that the 

leadership of the agency from different components, when there is 

a red flag, make sure we do whatever we need to do to get to the 

right answer quickly. When we get to the right answer, we believe 

we can make it happen quickly. 

Ms. SCHAKOWSKY. There is some concern that FSMA has not 

been fully implemented and enforced. Is there anything we can do 

to speed up that process? 

Mr. STEARN. We are actively working on FSMA implementation 

now. I’m very much engaged in that myself. And I don’t have anything today. I can bring that back to the agency if there’s anything 

else to add. 

Ms. SCHAKOWSKY. Thank you. I yield back. 

Mr. HARPER. The gentlelady yields back. The Chair will now recognize the gentleman from Georgia, Mr. Carter, for 5 minutes. 

Mr. CARTER. Thank you. And thank both of you for being here. 

This is obviously a very important subject, particularly for us in 

the State of Georgia. As you know, we had the unfortunate incident 

some years ago with the peanuts, and that’s still fresh in our 

minds. 

Mr. Stearn, let me ask you, when you released the updated guidance yesterday on accelerating the recall process, part of it included the FDA to step in if a company hadn’t sufficiently addressed a recall. How do you determine if they sufficiently addressed it or not? 

Mr. STEARN. Right. So the guidance yesterday we released talks 

about public warning and notification. It talks about when we 

think a company should issue a warning, and we describe how that 

should be done, and when FDA will issue public warnings, as well 

as some changes in notification. This goes back to the issue we 

were talking about earlier in terms of, you know, FDA has to get 

to the right answer in terms of evaluating the issue as soon as possible. So if we understand the issue, we think it’s best when we 

have a consistent message with a company that’s responsible. 

There’s not dueling messages, it’s clear and that’s what we—— 

Mr. CARTER. How often does that happen, that you have dueling 

messages? 

Mr. STEARN. I would say the overwhelming number of times we 

can get to the right answer, you know, in terms of our communications with a company. There are times where—and it’s not the 

usual case. 

Mr. CARTER. Is the right answer always your answer or—— 

48 

Mr. STEARN. I’m sorry? 

Mr. CARTER. Is the right answer always your answer, or does the 

company—— 

Mr. STEARN. Well, we do have a dialogue with companies, I 

mean, we do listen to them, and some companies have—I have 

been engaged in a number of technical conversations where a company has said things that have changed our minds, so that does 

happen. Sometimes we’re dealing with a company, though, where 

they don’t understand the problem. We need to get a message to 

consumers, and if they are not willing to do that, we have to be 

willing to do that. 

Mr. CARTER. If that is the case, sir, there are repercussions for 

that company? 

Mr. STEARN. So ordinarily, I mean, most of our recalls, the firm 

prepares a press release, we comment on that press release. We 

want to make sure it is actionable for consumers. If a firm will not 

or cannot do that, the FDA will, or if we think that it is appropriate even when a firm has done it, because we will have to reach 

a certain population or there’s a way to do it that we think is necessary, FDA will issue its own consumer communication. 

Mr. CARTER. You issue it, are there any penalties to the company? 

Mr. STEARN. Oh, to the company? No. 

Mr. CARTER. If you have to step in and you have to exert that 

energy, and you have to exert that authority, there ought to be 

ramifications. 

Mr. STEARN. Right. I do think—one of the things I go back to, 

which is not fully developed, but under the preventative control 

rule within FSMA, firms have to have their own recall plan, 

and—— 

Mr. CARTER. Is that approved by FDA? The recall plan? 

Mr. STEARN. Well, it is not formally approved. But it is, I say, 

when we go in, we have do have oversight responsibility, so they 

have some obligation to do it, and we could exercise some regulatory oversight if the firm did not act appropriately in that regard. 

Mr. CARTER. OK. Let me ask you, in December, the inspector 

general’s office of HHS released a report on food recall, the process. 

And understand when the FDA learned that a product was potentially hazardous, FDA stated that ‘‘tracking this data for all recalls 

would be time consuming and difficult, as the data may be located 

in different FDA systems or obtained from sources outside of FDA.’’ 

What kind of sources outside of FDA are you talking about? 

Mr. STEARN. Well, we may get information, I mean, we work 

with States a lot, so sometimes States have their own—there’s a 

lot of State inspections that States may find a food safety issue 

that they communicate to us. Sometimes we have information that 

comes from foreign governments. Sometimes we have information 

that comes from third-party sources. 

Mr. CARTER. If that’s information that is concerning, is there a 

time when the State feels like the FDA needs to know this, they 

send you that information? 

Mr. STEARN. Yes, that happens. In fact, it happened in one of 

these cases. You know, we worked with Virginia. Virginia did some 

testing that kicked off the cheese recall we were discussing earlier. 

49 

Mr. CARTER. So you feel like you have all the information that 

you need? That’s the question, because I know you can’t make a decision until you’ve got all the information. 

Mr. STEARN. I think I would just say one of the challenges that 

we have—and I think it is a challenge—is that we deal with thousands of firms, and there are a lot of different food safety issues. 

These days, we are also getting information from different sources, 

and that, in fact, happened in these cases. And we need to find— 

we take the point, we need to find a way, it is part of the question 

is how, we need to find a way to make sure that we get all the relevant information in as soon as possible to make sure we get to the 

right answer. We take that point. 

I think, technically, there are some challenges, there are some 

challenges within our data systems, we have a lot of different ones. 

Mr. CARTER. Is there anything we can do to assist you with that? 

Mr. STEARN. I would have to take that back to the agency. 

Mr. CARTER. OK. Know that we are ready and willing. OK? 

Thank you for the work that you do. It is extremely important, 

both of you. Thank you very much. 

Mr. STEARN. Thank you, sir. 

Mr. CARTER. And I yield back. 

Mr. HARPER. The gentleman yields back. I want to thank you, 

Ms. Jarmon, and you, Mr. Stearn, to shed some light on where we 

are and recognizing the importance of this issue, and we appreciate 

you being here today. I remind Members that they have 10 business days to submit questions for the record. I ask that the witnesses agree to respond promptly to any questions that are submitted. 

With that, this subcommittee’s adjourned. 

[Whereupon, at 10:30 a.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 

PREPARED STATEMENT OF HON. MICHAEL C. BURGESS

Today we continue our examination of food safety—a matter which has been of 

interest to the American public ever since the publishing of Upton Sinclair’s ‘‘The 

Jungle’’ in 1906. The Food and Drug Administration’s (FDA) ability to ensure the 

safety of our food supply is an issue that affects every grocery store, restaurant, 

school, and home in America. 

The passage of the FDA Food Safety Modernization Act in December 2010 was 

a step in the right direction, giving FDA greater authority to regulate, inspect, and 

recall food when necessary. However, the recent report from the Office of Inspector 

General at the Department of Health and Human Services concluded that there is 

still work left to do. 

Mr. Chairman, thank you for holding this hearing. Also, thank you to our witnesses for being here today. I look forward to your testimony. 

I yield back. 

50 


E ~c U.S. HOUSE OF REPRESENTATIVES 

~ COMMITTEE ON ENERGY AND COMMERCE 

E$1.1795 

January 17, 2018 

TO: Members, Subcommittee on Oversight and Investigations 

FROM: Committee Majority Staff 

RE: Hearing entitled "Safety of the U.S. Food Supply: Continuing Concerns Over the 

Food and Drug Administration's Food-Recall Process." 

The Subcommittee on Oversight and Investigations will hold a hearing on Friday, 

January 19,2018, at 9:00a.m. in 2123 Rayburn House Office Building. The hearing is entitled 

"Safety of the U.S. Food Supply: Continuing Concerns Over the Food and Drug 

Administration's Food-Recall Process." 

This hearing will examine a December 2017 report by the U.S. Department of Health and 

Human Services (HHS) Office of Inspector General (OIG). The report identified a number of 

deficiencies in the U.S. Food and Drug Administration's (FDA) food recall process, including 

that FDA could not always ensure that firms initiated recalls promptly and that FDA did not 

always evaluate health hazards in a timely manner; issue audit check assignments at the 

appropriate level; complete audit checks in accordance with its procedures; collect timely and 

complete status reports from firms that have issued recalls; track key recall data in their 

electronic system; and maintain accurate recall data in the electronic data system. The purpose 

of the hearing is to determine the reasons for the identified deficiencies, to what extent the FDA 

Food Safety Modernization Act (FSMA) has improved FDA's oversight of food recalls since its 

passage in 2011, and what actions the FDA is taking to implement the report's recommendations 

or to address the deficiencies. 

I. WITNESSES 

• Gloria Jarmon, Deputy Inspector General for Audit Services, HHS Office of Inspector 

General; and, 

• Douglas Stearn, Office of Regulatory Affairs, Director, Office of Enforcement and 

Import Operations, Food and Drug Administration. 

II. BACKGROUND 

A. Estimates of health and economic impact from food borne illness 

In this decade, the Centers for Disease Control and Prevention (CDC) estimates that each 

year roughly one in six Americans (or 48 million people) gets sick, 128,000 are hospitalized, and 

3,000 die offoodborne illness.1 CDC data also show that the number of reported multistate 

1 CDC, Estimates ofFoodbome Illness in the U.S., available at https://www.cdc.gov/foodbomeburden/2011-

foodbome-estimates.htm I. 
51 


Majority Memorandum for January 19, 2018, Subcommittee on Oversight and Investigations 

Hearing 

Page2 

foodbome illness outbreaks is increasing over the past decade.2 According to the Government 

Accountability Office (GAO), this is notable because although multistate outbreaks make up a 

small proportion of total outbreaks, they affect greater numbers of people. 3 

Most who get sick from a foodbome illness will recover without any lasting effects; 

however, some individuals may suffer long-term health effects, such as kidney failure, chronic 

arthritis, or nerve damage.4 According to a May 2015 estimate from the U.S. Department of 

Agriculture's (USDA) Economic Research Service, the 15 most common foodbome pathogens 

together impose an economic burden related to foodbome illnesses, hospitalizations, and deaths 

in the United States of over $15.5 billion annually. 5 In 2015, FDA researchers estimated that 

health costs associated with foodborne illness are approximately $36 billion annually. 6 

In addition to the human health toll, foodborne illness outbreaks can impose high costs to 

industry from food recalls? A study published by the Grocery Manufacturers Association 

(GMA), surveying 36 GMA member companies, found that more than half had been affected by 

a product recall in the prior five years. 8 Based on the survey results, the four largest costs that 

companies face as a result of a recall are business interruption or lost profits; recall execution 

costs such as destroying and replacing recalled products; liability risk; and company or brand 

reputation damage. 

B. FDA authorities 

The Federal Food, Drug, and Cosmetic Act (FD&C Act) was passed by Congress in 1938 

and gives authority to the FDA to oversee the safety, of food, drugs, and cosmetics. The FD&C 

Act "requires FDA to safeguard the Nation's food supply, including dietary supplements, and 

ensure that all ingredients are safe."9 The FDA's Center for Food Safety and Applied Nutrition 

(CFSAN) and the FDA's Office of Regulatory Affairs (ORA) work together to oversee food 

recalls. The ORA district offices are responsible for overseeing recalls for any companies or 

2 CDC List of Selected Multistate Foodbome Outbreak Investigations, available at 

https://www.cdc.gov/foodsafety/outbreaks/multistate-outbreaks/outbreaks-list.html. 

3 U.S. GAO- High Risk: Improving Federal Oversight of Food Safety, (2017), available at 

htps://www .gao.gov/highrisk!improving_federal_ oversight_ food_ safety/why_ did _study. 4 Id 

5 U.S. Department of Agriculture, Economic Research Service, Economic Information Bulletin Number 140, 

Economic Burden ofFoodborne Illnesses Acquired in the United States, (May 2015), available at 

https://www.ers.usda.gov/webdocs/publications/4 3984152807 _ eib 140. pdf. 6 Travis Minor, et al., The Per Case and Total Annual Costs ofFoodborne Illness in the United States, 35 Risk 

Analysis 1125 (June 20 15), available at 

http://onlinelibrary. wiley.com/doi/1 0.1111/risa.l2316/abstract;jsessionid=BB 1 C19DE0558F076C9D49E994F582A 

30.f01t01. 

1 /d 

8 GMA, Covington & Burling, and Ernst & Young, Capturing Recall Costs: Measuring and Recovering the Losses, 

(2011), available at http://www.gmaonline.org/filemanager/images! gmapublications/Capturing_Recall_ Costs_ GMA _ Whitepaper _F!NAL.pdf. 9 Department of Health and Human Services Office of Inspector General, The Food and Drug Administration's 

Food-Recall Process Did Not Always Ensure the Safety of the Nation's Food Supply, (Dec. 2017), available at 

https://oig.hhs.gov/oas/reports/region llll601502.pdf. 
52 


Majority Memorandum for January 19,2018, Subcommittee on Oversight and Investigations 

Hearing 

Page 3 

"firms" where a recalling firm is located and therefore are responsible for providing guidance to 

the recalling firms and monitoring day-to-day activities related to the recalls. 

In January 2011, FSMA was signed into law. This law gives the Secretary ofHHS 

authority to conduct mandatory recalls and assess and collect fees related to food facility reinspections and food recall orders. FSMA "aims to ensure the U.S. food supply is safe by 

shifting the focus from responding to contamination to preventing it." 10 In order for FDA to use 

its mandatory recall authority, FDA must determine that there is a reasonable probability that the 

food is adulterated or misbranded and that it will cause serious adverse health consequences or 

death to humans or animals. To date, FDA has initiated the process to use its mandatory recall 

authority twice; once in February 2013 and once in November 2013. 11 

"A recall is a firm's removal or correction of a marketed product that FDA considers to 

be in violation of the FD&C Act and against which FDA would initiate a legal action (e.g., 

seizure)."12 Corrections may include repair, modification, adjustment, relabeling, destruction, or 

inspection of a product without its physical removal to some other location. 13 Food recalls are 

the most effective means of protecting public health when a widely consumed food product is 

either defective or potentially harmful. 14 

FDA completes a health hazard evaluation (HHE) for each recall, which is used to 

classify the recall and assess the firm's recall strategy. A recall may be classified as Class I, II, or 

III. In Class I recalls, there is a reasonable probability that the use of or exposure to a violative 

product will cause serious adverse health consequences or death. 15 In Class II recalls, the use of 

or exposure to a violative product may cause temporary or medically reversible adverse health 

consequences or the probability of serious adverse health consequences or death is remote. 16 In 

Class Ill recalls, the use of or exposure to a violative product is not likely to cause adverse health 

consequences. 17 

C. Recent audits before the 2017 OIG Report 

Prior to the 2017 report and the enactment of FSMA, OIG had issued two audits related 

to FDA food recalls. In 2009, the OIG reviewed the FDA's monitoring of pet food recalls. 18 

Among the deficiencies noted, the OIG found: FDA did not always follow its procedures in 

10 U.S. Food & Drug Administration, FDA Food Safety Modernization Act (FSMA), available at 

https://www.fda.gov/Food/GuidanceRegulation/FSMN. 

11 0 I G report, supra note 9. 12 ld. at 2. 13 GAO, Food Safety: FDA's Food Advisory and Recall Process Needs Strengthening, GA0-12-859, (July 2012), 

available at https://www.gao.gov/assets/600/593031.pdf. 14 OIG report, supra note 9 at l. 15 21 CFR § 7.3. 16 Id 

11 Id 18 Department of Health and Human Services Office oflnspector General, The Food and Drug Administration's 

Monitoring of Pet Food Recalls, A-01-07-01503, (Aug. 2009), available at 

https:/ /oig.hhs.gov /oas/reports/region 1/1 070 1503 .pdf. 
53 


Majority Memorandum for January 19, 2018, Subcommittee on Oversight and Investigations 

Hearing 

Page4 

overseeing three of the five recalls reviewed; FDA's procedures were not always adequate for 

monitoring large recalls; occasional lax adherence by FDA to its recall guidance and internal 

procedures and the inadequacy of some of those procedures; and limited FDA ability to ensure 

that contaminated pet food was promptly removed from retailers' shelves. 

In 2011, the OIG reviewed the FDA's monitoring of imported food recalls. 19 The OIG's 

review found that FDA's guidance for developing and implementing food recalls was not 

adequate to ensure the safety of the Nation's food supply because it was not enforceable. In 

addition, FDA did not always follow its own procedures for ensuring that the recall process 

operated efficiently and effectively. Among its observations, the OIG found that FDA did not 

always conduct timely and complete audit checks of consignees, or did not review recall 

strategies and promptly issue notification letters to firms conveying the review results and other 

essential instructions. 

The GAO also raised concerns about FDA's food recall process in 2012, noting that.FDA 

faced a number of communication challenges when advising the public about food recalls or 

outbreaks offoodborne illness.20 In addition, in 2017, the GAO continued to include federal 

oversight of food safety on the high-risk list.21 Improving federal oversight of food safety has 

been on GAO's high-risk list since 2007.22 

D. HHS OIG Early Alert 

The HHS OIG started its review of FDA's food-recall process in early 2015, with field 

work starting in April2015.23 In June 2016, HHS OIG issued an Early Alert memorandum to 

FDA on a preliminary finding from its ongoing audit. The early alert raised concerns that FDA 

did not have adequate policies and procedures to ensure that firms take prompt and effective 

action in initiating voluntary recalls."24 Two months earlier, the FDA established a team of 

senior leaders to make decisions in the most challenging food recall cases.25 The team is called 

SCORE (Strategic Coordinated Oversight of Recall Execution).26 FDA's hearing witness, 

Douglas Stearn, is a co-leader of SCORE. According to FDA, SCORE has reviewed and 

directed a large number of operations in the most difficult cases that FDA faced during the April 

2016- October 2017 time period.27 The agency believes SCORE has made a difference in 

"U.S. Department ofHealth and Human Services, Office ofinspector General, Review of The Food and Drug 

Administration's Monitoring of Imported Food Recalls, A-01-07-01503, (Aug. 2009), available at 

https://oig.hhs.gov /cas/reports/region I /1070 1503 .pdf. 20 U.S. Government Accountability Office, Food Safety: FDA's Food Advisory and Recall Process Needs 

Strengthening, GA0-12-589, (July 20 12), available at https://www.gao.gov/assets/600/59303l.pdf 21 U.S. Government Accountability Office, High Risk Series: Progress on Many High-Risk Areas, While Substantial 

Efforts Needed on Others, GA0-17-317, (Feb. 2017), available at https://www.gao.gov/assets/690/682765.pdf. 22 GAO, High-Risk Series: An Update, GA0-07-310, (Jan. 2007), available at 

https://www.gao.gov/assets/260/25595l.pdf. 

23 OIG Report, Appendix C: Audit Scope and Methodology, supra note 9 at 32. 24 OIG report, supra note 9. 25 FDA Comments (Oct. 6, 2017), Appendix J to HHS OIG Dec. 2017 report. 

26 !d. 

27 Id 
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Majority Memorandum for January 19,2018, Subcommittee on Oversight and Investigations 

Hearing 

Page 5 

ensuring that FDA acts quickly to investigate and reduce consumer exposure to potentially 

harmful foods on the market.28 FDA also has recently initiated a new quality systems audit 

process and a plan to provide earlier notice to the public and more guidance to staff.29 HHS OIG 

acknowledged that the Early Alert memorandum and its review spurred major changes in FDA's 

oversight of the process, but maintained the recommendations in the Early Alert memorandum in 

the report. 30 

E. HHS OIG December 2017 Report 

The HHS OIG audit covered 30 voluntary food recalls (23 Class I and seven Class II) 

')udgmentally" selected by the OIG from the 1,557 food recalls reported to FDA between 

October!, 2012, and May 4, 2015. The OIG focused on FDA's (I) oversight of firms' initiation 

of food recalls, (2) monitoring of firm-initiation of food recalls, and (3) maintenance of foodrecall data in the electronic recall data system. The OIG report found deficiencies in each of 

these areas. 

The OIG found: 31 

• FDA could not always ensure that firms initiated recalls promptly. The 30 voluntary 

recalls reviewed had a median of 29 days to initiate, with an average of 57 days. 

Initiation of these recalls ranged from nine days before to 303 days after FDA learned 

that the product was potentially hazardous. The timeliness of recalls depended on how 

quickly firms chose to respond to safety information, whether FDA and the firm disputed 

the lawfulness of a product, or whether the firm lied to FDA about suspending 

manufacture and distribution of a product. Recalls were not always initiated promptly 

because FDA did not have adequate procedures to ensure that firms take prompt and 

effective action in initiating voluntary recalls. 

• FDA did not always evaluate health hazards in a timely manner. For the 14 recalls that 

the OIG could evaluate for timeliness, the median working days to complete the HHE 

after learning of a planned or in-progress recall was 27 working days, with an average of 

47 days. There were three reasons for FDA not completing some HHEs in a timely 

manner: (I) FDA did not always follow the 24-hour timeframe in its procedures for 

submitting the recall alert to an electronic data system called the Recall Enterprise 

System (RES) after learning of a firm's decision to recall; (2) FDA sometimes had 

difficulties obtaining necessary information for decisions about the seriousness of the 

health hazard because the firm's lack of responsiveness or the firm's own difficulties 

obtaining information; and (3) FDA's interim mandatory recall procedures did not 

include factors to consider when determining the existence of a reasonable probability 

that a food would cause serious adverse health consequences or death. 

"Ed. 

29 Id. 

30 OJG report, supra note 9, at 4. 31 OIG report, supra note 9. 
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Majority Memorandum for January 19, 2018, Subcommittee on Oversight and Investigations 

Hearing 

Page6 

• FDA did not always issue audit check assignments consistent with the level of the 

proposed audit program. A recall "audit check" is a visit, telephone call, or letter from 

FDA staff to a consignee to verify that the consignee has been notified of the recall, and 

has taken appropriate action.32 For 19 of the 27 recalls, the FDA monitoring district 

office issued audit check assignments at the level of the proposed audit program. For the 

remaining eight recalls, fewer audit checks were issued than what was required for the 

level in the proposed program. FDA did not always issue audit checks at assigned levels 

or based on accurate distribution information because FDA recall coordinators (1) had 

insufficient oversight to ensure that the assignment was at the appropriate level or (2) 

obtained incomplete or inaccurate information from the firm. 

• FDA did not always complete audit checks in accordance with procedures. For 21 of the 

25 audit checks that were conducted in the OIG sample, FDA did not complete the last 

audit check within 20 days of issuance of the firm's recall communication. For these 21 

recalls, the median days for FDA to finish the audit check after the firm issued its recall 

communication was 69 days, with an average of 118 days. The OIG noted that FDA did 

not retain a third-party contractor to assist with audit checks despite limited staff 

resources. The OIG also observed that the FDA staff did not always provide regular 

updates to the recall coordinator and that the recall coordinators did not always follow up 

with district offices to ensure that audit checks were completed in a timely manner. None 

of the FDA data systems could be used to assist staff with tracking results of audit 

checks. 

• FDA did not always collect timely and complete status reports from recalling firms. For 

11 of the 30 recalls, FDA either did not request or collect status reports. For the 

remaining 19 recalls, the median days for FDA to collect the first status report was 122 

days, with an average of 143 days. In addition, for the 19 recalls in which at least one 

status report was provided, five did not contain complete effectiveness check 

information. FDA's procedure for collecting timely and complete status reports was 

inadequate because the procedures did not require staff to request status reports at the 

time the recall was initiated. FDA also did not always include the request for status 

reports in the recall notification letter or follow up with firms when the status reports 

were not provided, provided late, or were incomplete. 

• FDA did not track key recall data in the electronic recall enterprise system. FDA did not 

have established performance measures and indicators to track key milestones of the 

food-recall process, in accordance with federal internal control standards. In addition, the 

FDA RES data system did not track all information necessary for FDA to effectively 

monitor recall activities and assess the timeliness of recalls. For example, FDA could not 

use the RES to calculate that it took 151 days to initiate the recall of hazelnuts 

contaminated with Salmonella. 

32 FDA 2017 Investigations Operations Manual, chapter 7.3.2.1, available at 

https://www.fda.gov/downloads/ICECI/Inspections/IOMIUCMI23513.pdf. 
56 


Majority Memorandum for January 19, 2018, Subcommittee on Oversight and Investigations 

Hearing 

Page 7 

• FDA did not always maintain accurate recall data in the recall enterprise system. For II 

of the 30 recalls (3 7 percent), the RES contained an inaccurate recall initiation date, 

which was off by a median of four days and an average of 16 days. FDA's RES User 

Manual did not clearly define the term "recall initiation" date, and therefore, FDA staff 

input other dates into the RES. Finally, FDA did not have a data quality assurance 

process to help ensure that RES data was accurate and complete. 

As a result of these findings, the OIG issued 14 recommendations to FDA. The OIG 

recommended that FDA: 

• Establish set timeframes, through its SCORE initiative, for FDA to (I) discuss the 

possibility of a voluntary recall with a firm and (2) initiate its use of its mandatory recall 

authority; 

• Include in its recall audit plan a step to monitor when the recall alert was submitted to the 

RES, and if appropriate, take steps to encourage submission of the recall audit plan to the 

RES as soon as possible; 

• Finalize its interim mandatory recall procedures and consider issuing guidance for FDA 

staff on factors that should be considered in determining a reasonable probability that a 

food could cause a serious adverse health consequence or death; 

• Ensure, through its recall audit plan, that audit checks are issued at the level specified in 

the FDA audit program; 

• Develop procedures to ensure FDA uses complete and accurate distribution lists when 

assigning audit checks; 

• Increase the use of third-party audits through its recall strategic plan; 

• Ensure through its recall audit plan that FDA audit checks follow procedures; 

• Improve audit check tracking and monitoring using the RES or another FDA system; 

• Implement procedures to request status reports at the initiation of the recall and ensure 

follow-up with firms that do not provide timely or complete status reports; 

• Develop a policy for defining and a procedure for identifying retrospectively the date that 

FDA learns of a potentially hazardous product; 

• Establish performance measures for the length of time between the date FDA learns of a 

potentially hazardous product and the date a firm initiates a voluntary recall; 

• Clarify the definition of "recall initiation date" in its policies and procedures; 
57 


Majority Memorandum for January 19, 2018, Subcommittee on Oversight and Investigations 

Hearing 

PageS 

• Develop and implement a data quality assurance process to ensure that the RES contains 

accurate information; and 

• Consider the results of the OIG review when implementing recent SCORE initiatives. 

F. FDA comments 

FDA agreed with the OIG's conclusion that it needed to help ensure that recalls are 

initiated promptly in all circumstances and said that it will consider the results of the OIG review 

as it "continues to operate the SCORE team." FDA also described actions it took in response to 

the OIG's June 2016 Early Alert. Although FDA has claimed that the OIG's recall sample was 

an "extreme outlier," FDA Commissioner Scott Gottlieb has stated that "[e]venjust a handful of 

problematic recalls are too many, because lives are at stake.'m Dr. Gottlieb also stated that the 

FDA agreed that in some situations identifying the retail stores not just the food manufacturer 

and distributor would help, and the agency is looking into the collection and release of this 

information.34 In addition to the issues identified by the OIG, the FDA through its SCORE 

initiative is also identifying approaches for improving the timeliness of its food recall process. 

Although there have been only two mandatory recalls since FSMA was enacted, the FDA 

told bipartisan committee staff that it believed the mandatory recall authority improved FDA's 

leverage during recall discussions with firms and was helpful to industry response since the law 

provided a legal foundation for the firm's role in recalls.35 FDA also told staff that the FDA 

laboratories, primarily ORA laboratories, provide sample-testing that can be part and a critical 

component of the HHE.36 However, FDA acknowledged that there are issues with turnaround 

time in getting test results from the labs. 37 

Regarding oversight of training, scientific capability, and safety of labs, the FDA, partly 

in response to the Oversight and Investigations Subcommittee's April2016 hearing on federal 

select agents,38 established the FDA Office of Laboratory Science and Safety (OLSS). In 

accordance with the recommendations of an external federal working group and the model 

followed by the CDC, the OLSS is located in the Office of FDA Commissioner with the OLSS 

Director being a direct report to the Commissioner. However, FDA is not yet completely 

following the working group recommendation and the CDC model because it has not established 

33 FDA Commissioner Scott Gottlieb, "FDA: We're working to protect consumers," USA Today (Jan. 2, 2018), 

available at https:/ /www.usatoday .com/story/opinion/20 18/0 1/02/fda-working-protect -consumers-editorialsdebates/1 09104418/. 34 !d. 

35 FDA briefing with bipartisan Committee staff, Jan. 12, 2018. FDA staff also stated that FDA is not requesting 

additional authority. 36 !d. 

37 /d. 38 How Secure Are U.S. Bioresearch Labs? Preventing the Next Safety Lapse, Hearing before the House Energy and 

Commerce Subcommittee on Oversight and Investigations (April20, 2016), available at 

https://energycommerce.house.gov/hearings/how-secure-are-us-bioresearch-labs-preventing-next-safety-lapse/. 
58 


Majority Memorandum for January 19,2018, Subcommittee on Oversight and Investigations 

Hearing 

Page 9 

a dedicated and independent source of funding for OLSS and a permanent staff for OLSS.39 

Instead, OLSS is being supported by funding from the FDA Centers and relies temporarily on 

detailees for staffing. FDA is still working to establish the long-term funding for OLSS. As a 

result, it appears that the FDA OLSS has not conducted any GAO-recommended40 annual 

inspections of the FDA labs during the last two years.41 

III. ISSUES 

The following issues may be examined at the hearing: 

• What is FDA doing to ensure that recalls are initiated promptly? 

• How does FDA plan to improve the audit check process? 

• How does FDA plan to better track and maintain accurate recall data in their electronic 

data system? 

• What impact has FSMA had on the FDA food-recall process? 

• How does the HHS OIG plan to follow-up in its next audit to determine whether the FDA 

has implemented the OIG recommendations and is making progress with the food-recall 

process? 

IV. STAFF CONTACTS 

If you have any questions regarding the hearing, please contact Alan Slobodin, Brittany 

Havens, or Jen Barbian of the Committee staff at (202) 225-2927. 

39 Email from FDA Office of Legislative Affairs to Committee Staff, (Aug. 30, 2017), ("In FY 2017, OLSS 

recruited 19 individuals through temporary detail assignments and contract support, but did not hire any permanent 

FTEs .... Absent a direct appropriation for OLSS in FY 2018, OLSS will not be funded through a central source, 

and instead FDA will identify an appropriate method to utilize funding Congress provides the agency to support the 

lab safety program. One possibility being considered is allocating costs across FDA Centers based on the level of 

support OLSS will provide to their lab programs."). 40 U.S. Government Accountability Office, High-Containment Laboratories: Comprehensive and Up-to-Date 

Policies and Stronger Oversight Mechanisms Needed to Improve Safety, GA0-16-305, (March 2016), available at 

https://www.gao.gov/assets/680/675925.pdf. 

41 Email from FDA Office of Legislative Affairs to Committee Staff, December 6, 2017 ("Regarding annual 

inspections, which are currently performed by FDA Centers and ORA, FDA is providing a standardized process to 

support this work. To further strengthen the process, OLSS intends to conduct audits of the inspection reports being 

produced by the centers."). 
59 


GREG WALDEN, OREGON 

CHAIRMAN 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

ONE HUNDRED FIFTEENTH CONGRESS 

~ongrtss of tbt llnittb ~tatts 

J!)ouse of l\epresentatibes 

COMMITIEE ON ENERGY AND COMMERCE 

2125 RAYBURN HousE OFFICE BuiLDING 

WASHINGTON, DC 20515-6115 

Ms. Gloria Jannon 

Deputy Inspector General 

Audit Services 

Office oflnspector General 

Department of Health and Human Services 

330 Independence Avenue, S.W. 

Washington, DC 20201 

Dear Ms. Jarmon: 

Majority (202} 225-2927 

Minority ~202} 225-3641 

February 7, 2018 

Thank you for appearing before the Subcommittee on Oversight and Investigations on January 

19, 2018, to testify at the hearing entitled "Safety of the U.S. Food Supply: Continuing Concerns Over the 

Food and Drug Administration's Food-Recall Process." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open for ten business days to permit Members to submit additional questions for the record, which are 

attached. The format of your responses to these questions should be as follows: (I) the name of the 

Member whose question you are addressing, (2) the complete text of the question you are addressing in 

bold, and (3) your answer to that question in plain text. 

To fucilitate the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on Wednesday, February 21,2018. Your responses should be 

mailed to Ali Fulling, Legislative Clerk, Committee on Energy and Commerce, 2125 Rayburn House 

Office Building, Washington, DC 20515 and e-mailed in Word format to Ali.Fulling@mail.house.gov. 

Thank you again for your time and effort preparing and delivering testimony before the 

Subcommittee. 

Sincerely, 

&, 

Greg~ Chairman 

Subcommittee 011 Oversight and Investigations 

cc: The Honorable Diana DeGette, Ranking Member, Subcommittee on Oversight and Investigations 

Attachment 
60 


Gloria L. Jarmon, Deputy Inspector General for Audit Services, Office of Inspector General, 

U.S. Department of Health and Human Services, response to questions for the record following "Safety of 

the U.S. Food Supply: Continuing Concerns Over the Food and Drug Administration's Food-Recall 

Process." 

U.S. House Subcommittee on Oversight and Investigations, Committee on Energy and Commerce 

"Safety of the U.S. Food Supply: Continuing Concerns Over the Food and Drug Administration's 

Food-Recall Process" 

January 19, 2018 

Questions for the Record 

The Honorable Gregg Harper 

l. What was the total number of voluntary Class I food recalls reported to FDA between 

October 1, 2012, and May 4, 2015- i.e. the timeframe in which you picked the sample of 

recalls in which you focnsed on in the OIG's report? 

There were 679 voluntary class I food recalls during our timeframe. In addition, there were 121 food 

recalls that were not yet classified as of the time we received data from FDA. A portion of these 121 food 

recalls would likely have been classified as class I. 

The Honorable Michael C. Burgess 

1. Technology and data are revolutionizing many businesses and markets throughout our 

society and economy, but in order to take advantage of their power, we need to ensure that 

the data being shared is accurate. The HHS OIG report highlights that FDA's data 

collection and sharing has been hindering timely and effective food recalls. What steps is 

FDA taking to improve its data input and collection and to incentivize companies to share 

information in a timely manner? 

We defer to FDA to address steps being taken in response to our report. FDA has 6 months after OIG 

issues the final report to provide a management decision on all open recommendations. If FDA has 

completed action on a recommendation, it should provide evidence to OIG to review. OIG then reviews 

the update and determines whether the recommendation should be closed. In some instances in which 

new processes and procedures are put in place, OIG conducts a followup audit to determine whether the 

action taken has adequately addressed the finding. 
61 


2. The HHS OIG report outlines concerns surrounding the inaccuracy or incompleteness of 

information that companies provide to the FDA. Specifically, in a nut butter product case 

involving a Salmonella contamination, the firm was reluctant to provide FDA with 

information necessary to complete the Health Hazard Evaluation (HHE). To what extent 

can FDA engage with these companies to incentivize them to provide correct information in 

a timely manner? Are companies aware they are providing FDA with faulty information, or 

do you anticipate that their method of data collection is flawed? 

Our report focused on FDA's oversight of the food recall process. As such, we reviewed FDA's recall 

records and interviewed relevant FDA staff. We found that FDA may request additional information 

from a firm if FDA identifies inconsistencies in the firm's information. However, FDA generally relies 

on the information that recalling firms provide. We did not conduct site visits at recalling firms or 

interview recalling firms' personnel to discuss what information the firms provide to FDA during a recall 

or whether that information is complete and accurate. Therefore, we cannot determine whether recalling 

firms are aware that they are providing FDA with faulty information or whether their data collection 

methods are flawed. 

We note that sections 414(a) and 701(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as 

amended by section 101 the FDA Food Safety Modernization Act, authorize FDA to access and copy 

records relating to certain harmful foods. Section 10-4 of FDA's Regulatory Procedures Manual 

describes the authority, criteria, and procedure for inspecting records under these sections. Firms may not 

refuse to permit access to or copying of records requested under section 414 of the FD&C Act (section 

301(e) of the FD&C Act). 

3. You outlined in your written testimony that the methodology ofthis review included a 

sample of thirty FDA food recalls between a three-year period. How were these thirty 

recalls selected for review? 

a. Do you feel they are an accurate sample of the issues noted in your testimony? 

Our audit covered 30 voluntary food recalls (23 Class I and 7 Class II) judgmentally selected from the 

1,557 food recalls reported to FDA between October 1, 2012, and May 4, 2015. We selected recalls 

based on risk factors related to the timing of the recall and other risk factors. Timing-related risk factors 

included how long it took to initiate the recall, when the firm began notifying its distribution chain of the 

recall, when the firm issued a press release, how long it took to classify the recall, how long it took to 

complete the recall, and how long it took to terminate the completed recall. Other risk factors included 

the level of FDA's involvement in the initiation of the recall (i.e., firm-initiated, State-initiated, or FDAinitiated), the scope of the recall (i.e., depth of recall, number of consignees, number of days the product 

was manufactured, and number of days the product was distributed), the reason for the recall, the 

classification of the recall, and media coverage. 

The 30 recalls selected for review are an accurate sample of the issues noted in our testimony. Because 

we selected a judgmental sample, the sample results are informative about deficiencies in FDA's foodrecall oversight process, but may not be representative of the full population of FDA recalls. 

2 
62 

[Mr. Stearn did not answer submitted questions for the record by 

the time of printing.] 


GREG WALDEN, OREGON 

CHAIRMAN 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

Mr. Douglas Stearn 

Director 

ONE HUNDRED FIFTEENTH CONGRESS 

(:ongrt55 of tbt Wntttb ~tatts 

j.!}ouse of l\epnsentattbes 

COMMITIEE ON ENERGY AND COMMERCE 

2125 RAYBURN House OFFICE BuiLDING 

WASHINGTON, DC 20515-6115 Majority (202) 225--2927 

Minority i202) 225--3641 

February 7, 2018 

Office of Enforcement and Import Operations 

Office of Regulatory Affairs 

U.S. Food and Drug Administration 

12420 Parklawn Drive 

Rockville, MD 20857 

Dear Mr. Stearn: 

Thank you for appearing before the Subcommittee on Oversight and Investigations on January 

!9, 2018, to testify at the hearing entitled "Safety of the U.S. Food Supply: Continuing Concerns Over the 

Food and Drug Administration's Food-Recall Process." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open for ten business days to permit Members to submit additional questions for the record, which are 

attached. The format of your responses to these questions should be as follows: (I) the name of the 

Member whose question you are addressing, (2) the complete text of the question you are addressing in 

bold, and (3) your answer to that question in plain text. 

To facilitate the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on Wednesday, February21, 2018. Your responses should be 

mailed to Ali Fulling, Legislative Clerk, Committee on Energy and Commerce, 2125 Rayburn House 

Office Building, Washington, DC 20515 and e-mailed in Word format to Ali.Fulling@mail.house.gov. 

Thank you again for your time and effmt preparing and delivering testimony before the 

Subcommittee. 

Sincerely, 

&, 

Greg'ltr 

Chairman 

Subcommittee on Oversight and Investigations 

cc: The Honorable Diana DeGette, Ranking Member, Subcommittee on Oversight and Investigations 

Attachment 
63 


Attachment-Additional Questions for the Record 

The Honorable Gregg Harper 

1. How many foodrecalls did FDA issue last year? 

a. What about over the past 3 years? 

2. What was the total number of voluntary Class I food recalls reported to FDA for each of the last 

three fiscal years? 

a. How many mandatory Class I food recalls in each of the last three fiscal years? 

3. What is the average time it takes FDA to initiate a Class I food recall? 

4. Are food recalls taking the appropriate length of time to initiate and complete? 

a. If not, what needs to be done to speed up the process? 

5. In O!G's June 2016 Early Alett, the OIG concluded that FDA should set timeframes for FDA to 

request a voluntary recall and for firms to initiate the voluntary recall. OIG still included that 

recommendation in this report. Why didn't FDA do that after the Early Alert in June 20 16? 

a. Has FDA since implemented that recommendation? If yes, how and when? If not, does 

FDA plan to and is there a timeframe? 

6. What kinds of tests do FDA labs conduct in support of a food- related recall? What are the 

estimated number of samples tested by FDA labs each year? 

7. Do most of these laboratory tests take place in FDA's Office of Regulatory Affairs (ORA) labs or 

FDA's labs in its Center for Food Safety? 

8. How long does it take for FDA laboratories to conduct the test once the food aJTives in the 

laboratory? 

9. Does FDA have concerns about the tumaround time in getting test results from the labs? 

10. Does FDA collect information from the labs such as the type of test, date sample received, date 

test completed, date notification of recall was issued etc.? 

a. If so, does FDA look at this information, and if so, has FDA assessed the timeliness of 

FDA lab testing and communication of the results? What does it show over the past year? 

11. How long does it take the FDA to issue a recall notice once the laboratory testing has been 

concluded? 

12. Are there specific validated test protocols at FDA to support the testing to evaluate health hazards 

in a food recall? How does FDA know it is getting valid test results from its labs? 

13. When were these testing protocols developed and by whom? 
64 


14. How many new protocols have FDA developed and validated to stay abreast of advancement in 

science and to reduce the time line for testing results? 

15. The case involving contaminated products from the Peanut Corporation of America, the subject 

of a February 2009 hearing before this Subcommittee, showed that FDA will occasionally 

confront a lawless or uncooperative company in a food safety investigation. The OIG report 

highlights cases where the FDA's recall process was impeded or delayed by uncooperative or 

dishonest companies. One case that comes to mind, Oasis Brands, involved cheese products 

contaminated with listeria, and the owner continued to have his company ship cheese with listeria 

even though he had told, and therefore misled the FDA, about suspending deliveries. Some 

recalls were delayed up to 81 days in pa1t because of this deception. What can FDA investigators 

do to detect lying and deception sooner? 

16. According to the O!G report, an adulterated dietary supplement product was not recalled until 

303 days after a warning letter was issued because the FDA and the company disagreed about the 

lawfulness of the product. If the FDA is the umpire and is calling the balls and strikes on what is 

considered a lawful product, how is it that a company can stall the FDA by a continued dispute on 

lawfulness when lives are at stake? 

17. Is there any initiative at FDA to reduce the enforcement delays after sending a waming letter? If 

so, what are they? 

The Honorable Michael C. Burgess 

1. Technology and data are revolutionizing many businesses and markets throughout our society and 

economy, but in order to take advantage of their power, we need to ensure that the data being 

shared is accurate. The HHS OIG report highlights that FDA's data collection and sharing has 

been hindering timely and effective food recalls. What steps is FDA taking to improve its data 

input and collection and to incentivize companies to share information in a timely manner? 

2. The HHS OIG repmt outlines concerns surrounding the inaccuracy or incompleteness of 

information that companies provide to the FDA. Specifically, in a nut butter product case 

involving a Salmonella contamination, the firm was reluctant to provide FDA with information 

necessary to complete the Health Hazard Evaluation (HHE). To what extent can you engage with 

these companies to incentivize them to provide correct information in a timely manner? Are 

companies aware they are providing you wiih faulty information, or do you anticipate that their 

method of data collection is flawed? 

3. Communication of recalls is important for the local public health officials on the ground 

investigatin·g cases and making necessary interventions. How are recall notifications disseminated 

to local health officials? Is this data filtered to be applicable to the region/district or only 

nationwide recall notifications? 

4. FDA Commissioner Gottlieb released a statement on December 26, 2017 stating that he wants 

FDA to "do even more to make sure that consumers have the information they need to avoid 

hazardous products that are the subject of recalls or seek assistance if they may have been 

exposed to a recall food product." What steps is FDA taking, or planning to take, to ensure 

adequate communication with and awareness among consumers during a recall? 

2 
65 

Æ 


Tile Honorable Frank Pallone, Jr. 

1. FDA is still in the process of implementing key provisions of FSMA through regulations, 

including a requirement that firms in certain instances have recall plans in place. In order to 

realize the full potential of FSMA as Congress intended, these regulations must be implemented 

and enforced without delay. When will these regulations be fully implemented and enforced? 

2. What can be done to expedite the process of implementing and enforcing these regulations? 

3. In 2016, FDA established the Strategic Coordinated Oversight of Recall Execution (SCORE) 

initiative. Mr. Stearn's testimony indicated that SCORE is comprised of FDA senior leaders who 

make decisions during patticularly complex or unusual food recall cases. How many recalls has 

the SCORE initiative handled, and what was the nature of these recalls (including the recall 

classification)? 

4. Mr. Stearn's testimony indicated that one of the changes FDA has implemented since the OIG 

review was a new monthly monitoring system that indicates when a recall appears to be going 

slowly. What steps does FDA take when it determines that a recall is going slowly?