[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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29-708 PDF WASHINGTON : 2019
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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:]
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
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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