[House Hearing, 115 Congress]
[From the U.S. Government Publishing Office]


 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
                           
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]                           


      Printed for the use of the Committee on Energy and Commerce

                        energycommerce.house.gov


                               __________
                               

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                    COMMITTEE ON ENERGY AND COMMERCE

                          GREG WALDEN, Oregon
                                 Chairman

JOE BARTON, Texas                    FRANK PALLONE, Jr., New Jersey
  Vice Chairman                        Ranking Member
FRED UPTON, Michigan                 BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois               ANNA G. ESHOO, California
MICHAEL C. BURGESS, Texas            ELIOT L. ENGEL, New York
MARSHA BLACKBURN, Tennessee          GENE GREEN, Texas
STEVE SCALISE, Louisiana             DIANA DeGETTE, Colorado
ROBERT E. LATTA, Ohio                MICHAEL F. DOYLE, Pennsylvania
CATHY McMORRIS RODGERS, Washington   JANICE D. SCHAKOWSKY, Illinois
GREGG HARPER, Mississippi            G.K. BUTTERFIELD, North Carolina
LEONARD LANCE, New Jersey            DORIS O. MATSUI, California
BRETT GUTHRIE, Kentucky              KATHY CASTOR, Florida
PETE OLSON, Texas                    JOHN P. SARBANES, Maryland
DAVID B. McKINLEY, West Virginia     JERRY McNERNEY, California
ADAM KINZINGER, Illinois             PETER WELCH, Vermont
H. MORGAN GRIFFITH, Virginia         BEN RAY LUJAN, New Mexico
GUS M. BILIRAKIS, Florida            PAUL TONKO, New York
BILL JOHNSON, Ohio                   YVETTE D. CLARKE, New York
BILLY LONG, Missouri                 DAVID LOEBSACK, Iowa
LARRY BUCSHON, Indiana               KURT SCHRADER, Oregon
BILL FLORES, Texas                   JOSEPH P. KENNEDY, III, 
SUSAN W. BROOKS, Indiana             Massachusetts
MARKWAYNE MULLIN, Oklahoma           TONY CARDENAS, California
RICHARD HUDSON, North Carolina       RAUL RUIZ, California
CHRIS COLLINS, New York              SCOTT H. PETERS, California
KEVIN CRAMER, North Dakota           DEBBIE DINGELL, Michigan
TIM WALBERG, Michigan
MIMI WALTERS, California
RYAN A. COSTELLO, Pennsylvania
EARL L. ``BUDDY'' CARTER, Georgia
JEFF DUNCAN, South Carolina

                                 7_____

              Subcommittee on Oversight and Investigations

                       GREGG HARPER, Mississippi
                                 Chairman
H. MORGAN GRIFFITH, Virginia         DIANA DeGETTE, Colorado
  Vice Chairman                        Ranking Member
JOE BARTON, Texas                    JANICE D. SCHAKOWSKY, Illinois
MICHAEL C. BURGESS, Texas            KATHY CASTOR, Florida
SUSAN W. BROOKS, Indiana             PAUL TONKO, New York
CHRIS COLLINS, New York              YVETTE D. CLARKE, New York
TIM WALBERG, Michigan                RAUL RUIZ, California
MIMI WALTERS, California             SCOTT H. PETERS, California
RYAN A. COSTELLO, Pennsylvania       FRANK PALLONE, Jr., New Jersey (ex 
EARL L. ``BUDDY'' CARTER, Georgia        officio)
GREG WALDEN, Oregon (ex officio)

                                  (ii)
                                  
                                  
                             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

----------
\1\ Mr. Stearn did not answer submitted questions for the record 
  by the time of printing.

 
 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 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 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.
    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 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 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 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 Administration 
(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.
    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.
    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 food-recall 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.

 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.
    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:]
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    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 registration 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:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    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 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?
    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.
    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 
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 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 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 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.
    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 contamination 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?
    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.
    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.
    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 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.
    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?
    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----
    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.
    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.

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