[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]
THE ROLE AND PERFORMANCE OF FDA IN ENSURING FOOD SAFETY
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
SECOND SESSION
__________
MAY 6, 2010
__________
Serial No. 111-118
Printed for the use of the Committee on Energy and Commerce
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COMMITTEE ON ENERGY AND COMMERCE
HENRY A. WAXMAN, California, Chairman
JOHN D. DINGELL, Michigan JOE BARTON, Texas
Chairman Emeritus Ranking Member
EDWARD J. MARKEY, Massachusetts RALPH M. HALL, Texas
RICK BOUCHER, Virginia FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey CLIFF STEARNS, Florida
BART GORDON, Tennessee NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois ED WHITFIELD, Kentucky
ANNA G. ESHOO, California JOHN SHIMKUS, Illinois
BART STUPAK, Michigan JOHN B. SHADEGG, Arizona
ELIOT L. ENGEL, New York ROY BLUNT, Missouri
GENE GREEN, Texas STEVE BUYER, Indiana
DIANA DeGETTE, Colorado GEORGE RADANOVICH, California
Vice Chairman JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California MARY BONO MACK, California
MICHAEL F. DOYLE, Pennsylvania GREG WALDEN, Oregon
JANE HARMAN, California LEE TERRY, Nebraska
TOM ALLEN, Maine MIKE ROGERS, Michigan
JANICE D. SCHAKOWSKY, Illinois SUE WILKINS MYRICK, North Carolina
CHARLES A. GONZALEZ, Texas JOHN SULLIVAN, Oklahoma
JAY INSLEE, Washington TIM MURPHY, Pennsylvania
TAMMY BALDWIN, Wisconsin MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas MARSHA BLACKBURN, Tennessee
ANTHONY D. WEINER, New York PHIL GINGREY, Georgia
JIM MATHESON, Utah STEVE SCALISE, Louisiana
G.K. BUTTERFIELD, North Carolina
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
DORIS O. MATSUI, California
DONNA M. CHRISTENSEN, Virgin
Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
JERRY McNERNEY, California
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
PETER WELCH, Vermont
Subcommittee on Oversight and Investigations
BART STUPAK, Michigan, Chairman
BRUCE L. BRALEY, Iowa GREG WALDEN, Oregon
Vice Chairman Ranking Member
EDWARD J. MARKEY, Massachusetts ED WHITFIELD, Kentucky
DIANA DeGETTE, Colorado MIKE FERGUSON, New Jersey
MIKE DOYLE, Pennsylvania TIM MURPHY, Pennsylvania
JANICE D. SCHAKOWSKY, Illinois MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas
DONNA M. CHRISTENSEN, Virgin
Islands
PETER WELCH, Vermont
GENE GREEN, Texas
BETTY SUTTON, Ohio
JOHN D. DINGELL, Michigan (ex
officio)
C O N T E N T S
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Page
Hon. Bart Stupak, a Representative in Congress from the State of
Michigan, opening statement.................................... 1
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 3
Prepared statement........................................... 6
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 11
Hon. Robert E. Latta, a Representative in Congress from the State
of Ohio, opening statement..................................... 12
Prepared statement........................................... 13
Hon. Joe Barton, a Representative in Congress from the State of
Texas, prepared statement...................................... 87
Witnesses
Michael R. Taylor, Deputy Commissioner for Foods, Food and Drug
Administration; Accompanied by Steven M. Solomon, Assistant
Commissioner for Compliance Policy, Office of Regulatory
Affairs, Food and Drug Administration.......................... 16
Prepared statement........................................... 19
Answers to submitted questions............................... 90
Lisa Shames, Director, Agriculture and Food Safety, Government
Accountability Office.......................................... 37
Prepared statement........................................... 39
Jodi Nudelman, Regional Inspector General for Evaluation and
Inspections, Region II, Health and Human Services Office of
Inspector General.............................................. 63
Prepared statement........................................... 65
THE ROLE AND PERFORMANCE OF FDA IN ENSURING FOOD SAFETY
----------
THURSDAY, MAY 6, 2010
House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 2 p.m., in room
2123, Rayburn House Office Building, Hon. Bart Stupak (chairman
of the subcommittee) presiding.
Present: Representatives Stupak, Christensen, Dingell (ex
officio), Waxman (ex officio), Burgess, and Latta.
Staff Present: Phil Barnett, Staff Director; Bruce Wolpe,
Senior Advisor; Eric Flamm, FDA Detailee; Dave Leviss, Chief
Oversight Counsel; Stacia Cardille, Counsel; Erika Smith,
Professional Staff Member; Scott Schloegel, Investigator; Ali
Neubauer, Special Assistant; Derrik Franklin, HHS-OIG Detailee;
Karen Lightfoot, Communications Director, Senior Policy
Advisor; Elizabeth Letter, Special Assistant; Mitchell Smiley,
Special Assistant; Melissa Bartlett, Minority Counsel, Health;
Kevin Kohl, Minority Professional Staff Member; Ruth Saunders,
Minority Detailee; and Alan Slobodin, Chief Counsel, Oversight.
OPENING STATEMENT OF HON. BART STUPAK, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Stupak. This meeting will come to order.
Today we have a hearing entitled, ``The Role and
Performance of FDA in Ensuring Food Safety.''
The chairman, ranking member, and chairman emeritus will be
recognized for a 5-minute opening statement. Other members of
the subcommittee will be recognized for a 3-minute opening
statement. I will begin.
Today's hearing will mark the 12th hearing of the Oversight
and Investigations Subcommittee since January 2007 regarding
food safety issues. We have examined an E. coli outbreak traced
to tainted spinach, melamine-contaminated pet food, and the
industry practice of intentional exposure of meat and seafood
to carbon monoxide, among other inquiries. During this
Congress, the subcommittee has held hearings on a salmonella
outbreak associated with peanut products manufactured by the
Peanut Corporation of America; and actions and obligations of
food manufacturers and retailers that purchased tainted food
products; and the safety of bottled water.
Today, we will continue our oversight role and performance
in the food safety system by considering two reports. The first
is a Government Accountability Office report entitled, ``Food
Safety: Agencies Need to Address Gaps in Enforcement and
Collaboration to Enhance Safety of Imported Foods.''
GAO found that, despite the efforts and actions of the
three Federal agencies that share jurisdiction over imported
food--U.S. Customs and Border Protection, the U.S Department of
Ag's Food Safety and Inspection Service, and the U.S. Food and
Drug Administration--there are gaps in the enforcement and
collaboration that could allow high-risk foods to enter
domestic commerce without assurance that products are safe.
Specifically, the GAO found: the three agencies failed to
collaborate and to share food-related data effectively; FDA's
authority to ensure importer compliance is limited; the
agencies lacked the ability to assign unique identification
numbers for importing firms; and CBP faces challenges managing
inbound shipments.
The second report, ``FDA Inspections of Domestic Food
Facilities,'' was issued by the Department of Health and Human
Services, Office of the Inspector General. The report
identifies a number of challenges confronting FDA in
safeguarding domestically produced food.
OIG found that, on an average, FDA inspects only 24 percent
of domestic food facilities annually and that the number of
inspections declined from 2004 to 2008. The report also found
that FDA has not inspected 56 percent of the food facilities
under its jurisdiction during the past 5 years.
The inspector general found that, and I quote, ``When
violations were identified, FDA did not routinely take swift
and effective action to ensure that these violations were
remedied,'' end of quote. Additionally, the report found that
some companies who had violations at their facilities
significant enough to warrant regulatory action refused to
grant FDA inspectors access to their official records.
I am interested in learning more about these two reports
and what proactive steps the GAO and inspector general believes
FDA could be taking to ensure the safety of our Nation's food
supply. I am also interested in hearing from FDA on the recent
steps it has taken to reinvigorate its focus on food safety and
to improve and enhance food safety oversight.
The work of this subcommittee, coupled with the work of the
Health Subcommittee and the full committee on food safety,
culminated the introduction and passage of H.R. 2749, the Food
Safety Enhancement Act, which passed the House of
Representatives on July 30th, 2009.
The provisions contained in H.R. 2749 would address several
concerns raised by GAO. For example, Section 204 of the bill
requires all food importers to register with FDA annually,
comply with good importer practices, and pay a registration fee
of $500 in order to ship food to the United States. Section 206
requires that registered facilities have a unique facility
identifier or they will not be allowed to import food into the
country. I am interested in hearing from our witnesses how H.R.
2749 could help address the concerns raised in the two reports
before us today.
Our witnesses today include the authors of the two reports.
Lisa Shames is the director of the agriculture and food safety
at the Government Accountability Office. Jodi Nudelman is the
regional inspector general for evaluation and inspections for
Region II at the U.S. Department of Health and Human Services,
Office of Inspector General.
Joining them on the panel will be Mike Taylor, FDA deputy
commissioner for foods, and Steve Solomon, deputy assistant
commissioner for compliance policy, from the Food and Drug
Administration.
The members of this subcommittee were the first to sound
the alarm on the weaknesses of our food safety system. I look
forward to hearing from our witnesses today about progress that
has been made since we began pushing for reform more than 3
years ago and about the weaknesses that remain until we have an
effective food safety bill enacted into law.
We are fortunate that today's hearing was prompted by the
HHS and GAO reports rather than another widespread food
outbreak like we saw with the spinach in 2007, peppers in 2008,
and peanut butter in 2009. But make no mistake about it:
Without legislative action, it is not a matter of if but when
more lives will be put at risk by another outbreak. We cannot
afford to put off action any longer.
Mr. Burgess, opening statement, please?
OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS
Mr. Burgess. I thank the chairman for the recognition.
And I am pleased to join you and the other members on the
committee as we convene this hearing on the role of the Food
and Drug Administration to ensure food safety for the American
public. Food safety reform is relatively controversial, yet a
critical issue, competing for attention with a long list of
domestic priorities.
Last July, in a bipartisan fashion, the House passed food
safety legislation. I supported the legislation because, while
historically the performance of the FDA has been questioned, I
felt this was partly a result of inadequate tools.
But the enduring role of the Food and Drug Administration
today still remains a very complex question. The House
legislation did not address the future progress of future
inspection and whether or not it is the proper role of both the
Food and Drug Administration and the United States Department
of Agriculture to continue their bifurcated jurisdiction over
food. We heard, for instance, that a food such as pizza if it
has only cheese on it is wholly the province of the Food and
Drug Administration, whereas if it has pepperoni as well, it is
in the province of the U.S. Department of Agriculture.
One thing is crystal-clear without controversy: The future
of the FDA should not be as a reactive body dictated by the
events of yesterday, but rather an effective and efficient,
proactive agency preventing the emergencies of tomorrow.
And I agree wholeheartedly with the chairman of this
subcommittee when he says it is not a question of if but when.
Because, as we were coming into the room for this hearing
today, across the newswire from the Columbus Dispatch, Federal
health officials will come to Columbus this weekend to help
determine what is responsible for a three-State E. coli
outbreak that has sickened at least seven people there. So, as
we see, even tomorrow's headlines today are being covered in
this committee.
It is important for the Food and Drug Administration as
well as the industry to work cooperatively to reduce the number
of and help prevent food-borne illnesses and contamination
before the tainted products are able to enter the markets.
The Food and Drug Administration should make maximum use of
information technologies for risk assessment, but it has come
to my attention and the attention of the committee that the
Food and Drug Administration has delayed the rollout of the
promising new system, PREDICT. PREDICT uses a variety of
assessments to rank food import shipments according to risk.
The system is currently in use in New York and Los Angeles, but
the nationwide deployment was recently postponed indefinitely
because of technical problems.
And this is not the first time that we have heard of the
failure of the Food and Drug Administration to keep pace with
changes in technology. From the failures of the 510(k) medical
device process to the backlog of new drug applications to the
entire portfolio of food issues, the Food and Drug
Administration regulates fully 25 percent of all government
activity, yet the Food and Drug Administration remains
technologically in the 1990s. This is why scientific innovation
and information technology must play a central role in the
prevention and the strategic analysis that is essential to a
successfully functioning Food and Drug Administration.
We are going to hear from four witnesses today, including
two from the agency itself. And although much has been said
about the past limitations of the agency and the uptick in
funding shortfalls from a year ago, I do not believe that it is
simply a resource question and that simply increasing the
resources of the Food and Drug Administration will solve the
problems outlined before us today. After numerous hearings, we
have learned that simply providing more money to FDA will not,
by itself, result in a safer food supply.
From our agricultural imports to domestic manufacturing,
the Food and Drug Administration must streamline the process
and internal controls to identify high-risk products and
manufacturers before tainted goods are able to enter the food
supply. While continuing to collaborate with their counterparts
at the USDA and the Customs and Border Protection, the Food and
Drug Administration internal communications between Washington
and their regional offices at home and abroad must be
increased. Communication may not create the perfect system, but
it will create a more reliable and a more efficient one.
I am also interested in an update of the issues that still
hinder work of the FDA and any new ideas you may have to foster
innovation to improve the agency as a whole. As Commissioner
Hamburg recently said, it is simply not possible for FDA to
inspect our way to safety.
Congress must advocate for an all-of-the-above approach in
addressing food safety solutions. We must support and advocate
for the FDA to continue to advocate for risk-based approaches
to the inspection and testing processes, as well as support
improvements to modernize scientific standards, safety
controls, and information technology.
While these update reports from the Government
Accountability Office and from Health and Human Services
Inspector General are helpful, their reports do not change the
conversation regarding this domestic priority. Food safety is
important. Food safety legislation has passed the House. Food
safety is now awaiting Senate action.
So I hope today's hearing is not just to continue to put
pressure on the Senate to act for food safety. It is my
understanding that the Senate is already planning to vote on
this issue as soon as the Financial Services bill is finished.
I hope, instead, we also ask questions about whether the
progress and the evolution of food safety requires more
advancements than red-tape bureaucracy than the government will
logically allow.
I would like to thank the chairman again, and I look
forward to the testimony of our witnesses and to our questions.
I will yield back.
[The prepared statement of Mr. Burgess follows:]
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[GRAPHIC] [TIFF OMITTED] T6573A.002
[GRAPHIC] [TIFF OMITTED] T6573A.003
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[GRAPHIC] [TIFF OMITTED] T6573A.005
Mr. Stupak. Thank you, Mr. Burgess.
Mr. Waxman, full committee chairman, opening statement
please, sir?
OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mr. Waxman. Thank you very much, Mr. Chairman. I want to
commend you for calling this important hearing and to examine
the role of FDA in protecting the Nation's food supply.
Today we are going to hear from two reports, one from GAO,
the other from HHS Inspector General, about the FDA
performance. These two reports tell a story of an agency that
is trying to keep the food supply safe but needs new
authorities, more effective tools, and increased funding to
meet its obligation.
In GAO's report, it found that FDA needs to coordinate its
enforcement efforts better with other agencies. For example,
FDA and Customs and Border Protection should be able to work
together to assign a unique identification number to firms that
import our food. This is currently not the case. In fact, there
are some that have more than three identifiers, and GAO found
one firm had 75. These multiple identifiers make it more
difficult for FDA to track foods that are imported.
GAO also questioned whether FDA's current penalties are
sufficient to keep an importer from violating FDA requirements.
The OIG report focused on FDA's inspection of domestic food
facilities. They found that FDA inspected only 24 percent of
food facilities each year between 2004 and 2008. The number of
FDA inspections declined during that time, even as the number
of facilities increased. Over the course of 5 years, FDA failed
to inspect 56 percent of facilities that were subject to its
authority and only inspected an additional 14 percent.
These two reports are very disturbing. It is a similar
story to what we heard last year. We were told in the two
hearings on salmonella outbreak in peanut butter that sickened
over 700 people--and the investigators revealed executives at
the Peanut Corporation of America knew their peanuts were
testing positive for salmonella, but they chose to ship the
tainted food anyway.
Many of the concerns raised in these two reports and in the
wake of the salmonella outbreak are addressed by the Food
Safety Enhancement Act of 2009, which the House passed on a
bipartisan basis. The legislation contains critical fixes. I am
pleased that we are holding this important hearing. I hope the
Senate will act soon and we will have this new legislation in
place. And I hope we will see, through the efforts of
legislation and oversight, a more comprehensive food safety
regimen at FDA.
Thank you for holding the hearing. I yield back my time.
Mr. Stupak. Thank you, Mr. Chairman.
Mr. Latta for 3 minutes?
We will try to get them in.
OPENING STATEMENT OF HON. ROBERT E. LATTA, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF OHIO
Mr. Latta. Well, thank you very much, Mr. Chairman and
Ranking Member Burgess.
First of all, thanks for holding this subcommittee hearing
on the Food and Drug Administration ensuring food safety. And
it is also an honor being recently appointed on the Energy and
Commerce Committee, and I look forward to working with you on
the important issues that come before the Oversight and
Investigations Subcommittee.
Instances of contaminated food products are a serious
concern for the public. Just last week, the FDA announced that
contaminated materials were used in production of several lots
of pediatric Tylenol products. About 1,500 lots of the bottled
products are currently being recalled. Furthermore, as the
percentage of U.S. food supply imported from foreign countries
increases and bioterrorism continues to be a threat, food
safety is a critically important issue.
Last summer, the House debated H.R. 2749, the Food Safety
Enhancement Act, and it is expected that the Senate will soon
take action on the legislation.
I represent the largest agricultural district in the State
of Ohio and am a member of the House Agriculture Committee. I
believe that H.R. 2749 did not adequately address the concerns
of the agricultural community, nor was it referred to the
Agriculture Committee at that time for any hearings.
Additionally, the Congressional Budget Office estimates that
H.R. 2749 will authorize $2.314 billion over fiscal years 2010
through 2014 and that it will take $3.5 billion for the FDA to
administer the new regulatory activities under the legislation
at that time.
The spending level authorized by H.R. 2749 is of grave
concern, especially when the September 2009 GAO report found
that gaps in enforcement and collaboration currently undermine
food safety efforts among Customs and Border Patrol, the FDA,
and USDA's Food and Safety Inspection Service. Furthermore, the
same report indicates there is a lack of information sharing
between the FDA and States during a recall, which impedes
States' efforts to quickly remove contaminated food.
The safety and security of the Nation's food supply is of
utmost importance; however, with 15 Federal agencies already
administering at least 30 Federal laws concerning food safety,
I am concerned of the prospect of an increased size in the
bureaucracy, budget, and statutory authority for the FDA when
improvements in communication, collaboration, and technology
have been recommended by the GAO.
Mr. Chairman, I thank you for this opportunity. I look
forward to hearing the testimony from the witnesses on the
panel today. And I yield back.
[The prepared statement of Mr. Latta follows:]
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[GRAPHIC] [TIFF OMITTED] T6573A.007
Mr. Stupak. Thank you, Mr. Latta. Good to have you on
board. Look forward to working with you.
Mrs. Christensen for 3 minutes, please?
Mrs. Christensen. Thank you. I will try to be shorter than
that.
Every year, 300,000 people in this country are hospitalized
and 5,000 die after consuming contaminated food or beverages.
So thank you, Chairman Stupak and Ranking Member Burgess, for
following up on this issue.
It is very important that we explore the weaknesses in the
food safety network and the coordination, or lack of it,
between CBP, FSIS, and FDA, as well as any new authorities
these agencies might need. So I just look forward to hearing
the testimony of our witnesses and to working with the
subcommittee and the larger committee to address the gaps in
our food safety system.
And thank you, Chairman Stupak, once again, for holding
this hearing on this issue that is really vital to the safety
and health of everyone who lives in this country.
Mr. Stupak. Well, thank you.
And we have 2 minutes left to vote. We have a series of
votes. There are four votes, plus a motion to recommit. So we
are going to stand in recess until 3:15.
So this committee will be in recess until 3:15.
[Recess.]
Mr. Stupak. The committee will come to order.
Mr. Dingell, do you have an opening statement, sir?
Mr. Dingell. Mr. Chairman, I will dispense with my opening
statement. I thank you.
Mr. Stupak. Very good.
Then that concludes the opening statements by members of
the subcommittee. I call our first panel.
On our first panel we have Mr. Michael Taylor, deputy
commissioner for foods with the Food and Drug Administration;
accompanying him is Mr. Steven Solomon, assistant commissioner
for compliance policy at the Food and Drug Administration; Lisa
Shames, director of agriculture and food safety at the
Government Accountability Office; and Ms. Jodi Nudelman,
regional inspector general for evaluation and inspections for
the Health and Human Services Office of Inspector General.
We welcome you all.
It is the policy of this subcommittee to take all testimony
under oath. Please be advised that you have the right, under
the rules of the House, to be advised by counsel during your
testimony. Do you wish to be represented by counsel?
Everyone is shaking their head ``no,'' so I will take it as
no.
Please then rise, raise your right hand, and take the oath.
[Witnesses sworn.]
Mr. Stupak. Let the record reflect the witnesses replied in
the affirmative.
You are now under oath.
We are going to begin with your opening statement of 5
minutes, please. If you would like to submit a longer statement
for the record, it would be accepted.
Mr. Taylor, shall we start with you?
TESTIMONY OF MICHAEL R. TAYLOR, DEPUTY COMMISSIONER FOR FOODS,
FOOD AND DRUG ADMINISTRATION, ACCOMPANIED BY STEVEN M. SOLOMON,
ASSISTANT COMMISSIONER FOR COMPLIANCE POLICY, OFFICE OF
REGULATORY AFFAIRS, FOOD AND DRUG ADMINISTRATION; LISA SHAMES,
DIRECTOR, AGRICULTURE AND FOOD SAFETY, GOVERNMENT
ACCOUNTABILITY OFFICE; JODI NUDELMAN, REGIONAL INSPECTOR
GENERAL FOR EVALUATION AND INSPECTIONS, REGION II, HEALTH AND
HUMAN SERVICES OFFICE OF INSPECTOR GENERAL
TESTIMONY OF MICHAEL R. TAYLOR
Mr. Taylor. Yes, sir.
Good afternoon, Mr. Chairman, Ranking Member Burgess, and
members of the subcommittee. I am pleased to be here today with
my colleague, Dr. Steven Solomon, and to have this chance to
talk with the committee about FDA's food safety program.
I also want to really thank you, Mr. Chairman, as well as
Chairman Dingell, Chairman Waxman, and all the members of the
committee, for your leadership in passing the Food Safety
Enhancement Act, which we do hope will soon go to conference
with the bill now pending in the Senate.
As you know, food safety is an important priority for the
Obama administration. Soon after taking office, the President
established a Food Safety Working Group which brought together
experts from all Federal agencies with responsibilities related
to food safety.
In its July 2009 report, the working group recognized the
challenges posed by a rapidly changing and globalized food
supply and the need to shift our focus to preventing food
safety problems throughout the system. The working group also
recognized the importance of inspections, recommending that the
government prioritize crucial inspection and enforcement
activity, build on and enhance State and local food safety
efforts, and utilize better data to guide these efforts and
evaluate their outcomes.
In August of 2009, Commissioner Margaret Hamburg created my
office, the Office of Foods, to lead a unified FDA foods
program and to enhance FDA's ability to meet today's challenges
in food safety. We recently launched the One Mission, One
Program initiative, which involves over 100 experts from
throughout FDA who are addressing topics crucial to the future
success of the foods program and the implementation of the
anticipated new legislation. This includes an inspection and
compliance strategy group that is looking hard at the way we
conduct inspections.
FDA's food safety inspections have focused traditionally on
identifying sanitation, manufacturing, and product
contamination problems in food facilities and gathering
evidence of regulatory violations for use in possible
enforcement cases. These efforts have contributed significantly
to food safety over the years, but the preventive control
requirements and other new tools provided by H.R. 2749 would
greatly enhance the ability of FDA investigators and FDA
inspections to protect public health.
We will, of course, continue to act to remove contaminated
food from commerce, but our focus will shift from collecting
evidence of food safety problems after they have occurred to
ensuring that food companies are doing what is necessary to
prevent problems in the first place.
Our goal needs to be high rates of compliance with the
prevention-oriented standards envisioned by H.R. 2749. And to
achieve this, we envision our investigators conducting a wider
array of inspection activities than is common today and
targeting those activities in ways that get the maximum
compliance and public health bang for the buck.
The recent Office of Inspector General report on domestic
inspections is a useful snapshot of FDA's food safety system as
it has existed in recent years. OIG has identified areas of
opportunity for enhancing FDA's enforcement authority, and FDA
has already addressed many of the issues noted in the report.
For instance, improving the speed and predictability of
follow-up to inspections and strengthening the agency's
enforcement program are top agency goals. Last August,
Commissioner Hamburg announced six initiatives to ensure that
enforcement actions taken by the agency are swift, aggressive,
and will have a positive impact on public health.
FDA appreciates OIG's recognition of the gaps in the
agency's inspection authority, and we support their legislative
recommendations. These include the use of civil monetary
penalties for FD&C Act violations related to food and the
authority provided in Section 106 of H.R. 2749 for routine
access to all records bearing on whether a food may be in
violation of the act.
The GAO report of September 2009 raised some important
issues relating to the safety of imported food. The agency
agrees with many of GAO's recommendations, and we are working
to incorporate them into both short-term and long-term
initiatives.
The report looked at FDA's new PREDICT system for targeting
import shipments. This technology, which is deployed in Los
Angeles and New York, will improve import screening and
targeting to better prevent the entry of unsafe foods and
expedite the entry of non-violative foods. A pilot test of the
prototype system showed that PREDICT works to target shipments
that are more likely to be found violative when examined by
FDA.
FDA has encountered problems with rolling out PREDICT
nationwide due to difficulties with incorporating it into the
agency's outdated IT infrastructure, which is now undergoing
major upgrades. These problems have delayed the full deployment
of PREDICT, but we will continue to move forward as
expeditiously as possible, with full roll-out anticipated by
the end of the year. And we will continue to evaluate and
strengthen PREDICT as the project progresses.
FDA was encouraged that GAO recognized the importance of
new legislative authorities as a key to strengthening FDA's
oversight of imported foods. In accordance with GAO's
recommendations, FDA is working with Congress to obtain
authority for civil money penalties and to acquire the use of a
unique identifier by food facilities, both of which are
provided by H.R. 2749.
The House bill will provide other valuable tools for
ensuring that importers reliably verify--and this is really
important--reliably verify that the foods they import are
produced in accordance and compliance with the same prevention-
oriented standards that we would make applicable to foods
produced in the United States. We all know that for our food
safety system to be effective, prevention must begin at the
point of production, not at the port of entry.
Mr. Chairman, protecting our Nation's food supply remains a
top priority for FDA and the administration. We really are at a
historic moment for food safety in the United States. As we
work collaboratively to improve our authorities, our practices,
and our policies, it will enable us to meet the food safety
challenges of the 21st century. And we appreciate the support
of this committee and look forward to working with you in the
future.
Thank you.
[The prepared statement of Mr. Taylor follows:]
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Mr. Stupak. Thank you.
Mr. Solomon, do you have anything to add?
Mr. Solomon. No, thank you.
Mr. Stupak. Ms. Shames, would you like to do an opening
statement?
TESTIMONY OF LISA SHAMES
Ms. Shames. Yes, thank you.
Chairman Stupak, Ranking Member Burgess, and members of the
subcommittee, I am pleased to be here today to discuss FDA's
oversight of imported food.
Effective FDA oversight is critical to public health. About
60 percent of fresh fruits and vegetables and 80 percent of
seafood are imported.
My testimony today will focus on three key issues: FDA's
overseas inspections of imported food; gaps in import
enforcement; and statutory authorities that could further help
FDA.
First, regarding the inspections: The number of FDA's
overseas inspections has fluctuated since 2001. As shown in
Table 1, annual inspections ranged from 95 to 153 out of an
estimated 189,000 foreign firms. These inspections were
conducted in 56 countries, mostly in Mexico. FDA conducted 46
inspections in China during this time frame.
To augment these inspections, FDA has opened offices in
China, Costa Rica, and India and plans to open more in Mexico,
Chile, the Middle East, along with the European Union.
In addition, PREDICT, a risk-based computer program is to
assist FDA inspectors flag higher-risk food shipments. As Mr.
Taylor said, a pilot test of PREDICT was promising. PREDICT
nearly doubled the percentage of field examinations that
resulted in violations. However, FDA told us that PREDICT's
nationwide roll-out has been delayed, primarily because of
technical problems.
Second, we identified several gaps in enforcement that
could allow food with safety violations to enter U.S. commerce.
One gap is that FDA has limited authority to assess civil
penalties on violators. Importers post a monetary bond for
shipments to provide assurance that they meet U.S.
requirements. However, even though the bond may be up to three
times the value of the shipment, this sum may be negligible for
a large importer. An unscrupulous importer may consider
forfeiting the bond as a part of the cost of doing business.
FDA agreed with our recommendation that it seek authority to
assess penalties. We note that H.R. 2749 provides for assessing
penalties.
A second gap is the lack of unique identification numbers.
Importers get computer-generated ID numbers from FDA. Because
importers may provide their names and addresses slightly
differently for each shipment, multiple identifiers are
generated. FDA officials told us that firms have, on average,
three unique identifiers, and one firm had 75. In addition,
foreign firms are to register with FDA and are assigned a
registration number, as well. FDA told us that there may be
duplicate registration numbers, as well. FDA agreed with our
recommendation to pursue the use of specific identifiers. H.R.
2749 also provides for such a unique identifier system.
A third gap is that FDA does not share product distribution
lists with States during a food recall because the information
is considered commercially confidential. State officials told
us that, without this information, they lose time removing
recalled food from grocery shelves. FDA agreed with our
recommendation to find ways to share information to the States.
On a positive note, one gap we found appears to be
resolved. We were told that FDA now receives the arrival time
of imported food shipments. This can help FDA coordinate any
further review for high-risk imports.
Finally, we have made several recommendations that would
help FDA improve food safety oversight. GAO has called for
mandatory food recall authority. Currently, food recalls are
voluntary, and FDA has no authority to compel companies to
recall contaminated foods except for infant formula. Other
government agencies that regulate other products, such as toys
or car tires, have recall authority and have had to use it when
companies did not cooperate.
FDA should also strengthen its oversight of food
ingredients determined to be generally recognized as safe, or
GRAS. Companies may conclude a substance is GRAS without FDA's
approval and even without its knowledge because companies are
not required to inform FDA. FDA generally agreed with our
recommendation that it develop a strategy to require companies
to provide basic information about their GRAS determinations
and, in view of emerging science, to conduct reconsiderations
of GRAS ingredients.
We also recommended that FDA seek any statutory authority
that the agency determines it needs to implement our
recommendations.
And, lastly, FDA agreed with our recommendation that it
seek authority to issue regulations for preventive controls for
high-risk food. As Mr. Taylor said, FDA already has regulations
for preventive controls for seafood and juice which require
firms to analyze safety hazards and implement plans to address
those hazards. FDA officials told us that issuing regulations
for preventive controls might be one of the most important
things that they can do to enhance the oversight of fresh
produce.
We note that H.R. 2749 contains provisions that address
mandatory recall, GRAS ingredients, and preventive controls.
In conclusion, a substantial volume of our food supply is
imported. Our work has shown that FDA could strengthen its
oversight of imported food and close gaps in its enforcement by
assessing penalties, developing unique identifiers, and sharing
information with State agencies. Additional statutory
authorities to conduct a mandatory recall and to establish
preventive controls could further help FDA's food safety.
Mr. Chairman, this concludes my prepared statement, and I
would be happy to answer any questions that you or other
members of the subcommittee may have. Thank you.
[The prepared statement of Ms. Shames follows:]
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Mr. Stupak. Thank you.
Ms. Nudelman, your opening.
TESTIMONY OF JODI NUDELMAN
Ms. Nudelman. Good afternoon, Chairman Stupak, Ranking
Member Burgess, and other members of the subcommittee. I am
Jodi Nudelman, regional inspector general in New York for the
U.S. Department of Health and Human Services Office of
Inspector General. I appreciate the opportunity to appear
before you today to discuss our most recent review of FDA's
food inspections program.
FDA's inspections are an important tool for ensuring food
safety. Recent outbreaks, however, such as the salmonella
outbreak caused by peanuts in 2009, have raised questions about
FDA's inspection process and its ability to protect the
Nation's food supply.
Our most recent review focused on FDA's inspections of
domestic food facilities. In brief, our review found that more
than half of food facilities went 5 or more years without an
inspection. We also found that the number of FDA inspections is
going down, even as the number of food facilities is going up.
In 2004, FDA inspected over 17,000 facilities. In 2008, this
number dropped to fewer than 15,000. The number of high-risk
facilities inspected also declined during this time. If FDA
does not routinely inspect food facilities, it cannot be sure
that these facilities are complying with the law and that the
food they handle is safe.
Our review also found that FDA's inspectors are identifying
fewer violations in food facilities. During an inspection, an
inspector may find violations of FDA's regulations or laws.
Based on the nature of the violations, he or she may assign the
facility a classification. In the most severe cases, the
inspector will assign the facility an OAI classification, which
means ``official action is indicated.'' Between 2004 and 2008,
the number of facilities that received OAI classifications
dropped from about 600 to less than 300.
Most commonly, facilities received OAI classifications for
unsafe practices and unsanitary conditions in the facility.
These classifications resulted from violations such as food not
being adequately refrigerated or evidence of rodent
infestation. We also found that nearly three-quarters of the
facilities that received OAI classifications had a history of
violations. Even more concerning, half of these facilities had
been cited for the exact same violation in a prior inspection.
Further, our report found that FDA did not always take
swift and effective action to remedy the violations. When a
facility receives an OAI, FDA should consider taking some type
of regulatory action. In the year that we studied, FDA took
regulatory action against 46 percent of the facilities that
received OAIs. For the remaining, FDA either lowered the
classification or took no regulatory action.
Moreover, for a third of the facilities with OAIs, FDA did
not take additional steps to ensure that the violations were
corrected. This means that FDA did not reinspect these
facilities in a timely manner or review any other evidence to
determine whether the violations were corrected.
Based on these findings, we made six recommendations to
FDA. We recommended that FDA increase the frequency of its
inspections, especially its high-risk inspections; provide
additional guidance about when to lower OAIs; take appropriate
action against facilities with OAIs; ensure that violations are
corrected; seek the authority to access facilities' records
during an inspection; and, finally, consider seeking the
authority to impose civil penalties through administrative
proceedings.
In conclusion, our report identified significant weaknesses
in FDA's inspections program. We found that many food
facilities go without routine inspections. We also found that,
when FDA finds violations, it does not always take swift and
effective action to ensure that the violations are remedied.
Taken together, our findings demonstrate that more needs to be
done to protect public health and to ensure that FDA has the
necessary tools to keep food safe.
This concludes my testimony, and I welcome your questions.
[The prepared statement of Ms. Nudelman follows:]
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Mr. Stupak. Thank you.
And thank you to all the witnesses for your testimony.
And let me just apologize. We got tied up on the floor. I
thought we would be back by 3:15. It was about a half-hour
later. You never know what happens when you get to the floor.
We will now move to questions.
Mr. Taylor, let me ask you this. The FDA announced a
lettuce recall today. Freshway Foods is doing a voluntary
recall of shredded romaine lettuce with a use on date by May
12th--or use on or before May 12th. I guess three people have
been hospitalized.
In the trace-back, do we have any idea of where that
romaine is originating from?
Mr. Taylor. Our understanding of the investigation so far
is it came from a production site in Arizona, in Yuma, Arizona,
where this company had its growing operations. We don't know
the cause of contamination, but we do know that there was
product contaminated, people got sick. And so this recall is
highly appropriate to protect the public health.
Mr. Stupak. Is the lettuce strictly grown in Arizona, or is
it mixed with lettuce from Mexico, as we have seen in the past?
Mr. Taylor. Well, this is romaine that is grown just in
Arizona. And it is sold to institutions in a bulk sort of form,
is the general way in which this product is distributed.
Mr. Stupak. If I remember correctly, when we were out in
California, you were there with us, and we were doing some of
the farming there. And I thought Arizona and California had a
very good trace-back method. You could almost tell from what
field it came from. Would you care to comment on this in the
matter of this case?
Mr. Taylor. Well, in this case, once we had the company
identified, there was not a problem getting back to the source
of production.
Mr. Stupak. OK. So the production field produced right
there, and you don't know if it is in machinery or whether it
was the growing site.
Mr. Taylor. We don't know--yes, we are investigating, we
are back at the farm investigating the cause, so that
investigation goes on. But, as you know, there can be multiple
vectors, avenues for getting this kind of contamination into an
open field where product is growing.
Mr. Stupak. Right. It was for romaine that was used by the
May 12th. Today is May 6th. How long has this investigation
been going on?
Mr. Taylor. The first cases go back to--the first onset of
illness goes back to April 6th. But it has been only in the
last week or 10 days that we became aware of this. There is
that lag factor between people first becoming ill and it
getting reported.
Mr. Stupak. Right.
Mr. Taylor. And we found yesterday a positive sample of
lettuce, which really confirmed the epidemiological hypothesis
that this product was responsible for the problem. So there was
actually a very swift recall response once the evidence fell
into place.
Mr. Stupak. And I take it Freshway Foods has been
cooperative, no problems there?
Mr. Taylor. They have worked closely and responded very
quickly when the evidence came into place.
Mr. Stupak. OK.
Ms. Nudelman, let me ask you this. I am looking at page 10
of your report. That is where you start with Table 1, food
facilities inspected by the FDA, fiscal year 2004 through 2008.
And I think you testified the average of the inspections were
about 24 percent of all the places inspected. Correct?
Ms. Nudelman. Yes.
Mr. Stupak. Now, the one that struck me was, in 2004 you
had 59,305 facilities should be inspected; by 2008, it has
grown to 67,819. If my math is correct, that is about 8,514 new
facilities in less than 5 years.
How is the FDA going to keep up with more and more
facilities without the resources?
Ms. Nudelman. I think that is a good question. I mean,
clearly we document the number of facilities has grown and, at
the same time, the number of inspections has declined.
I think the other important factor in this is the number of
high-risk inspections that are completed. And that is one way
to target resources and target----
Mr. Stupak. Right. Well, if we jump to the next table, that
is Table 2, which is the high-risk facilities inspected by the
FDA and, again, through the same years, 2004 to 2008. You have
had, again, more high-risk facilities come online, about 565,
if my math is correct here. The number of inspections has
actually dropped from 77 percent to 63 percent.
Any correlation during that period of time from 2004 to
2008, how many inspectors did the FDA have? Did the number of
inspectors go down?
Ms. Nudelman. That is correct. And this is one of the
things that FDA talked about in terms of the reason why there
was a decline in the number of high-risk inspections as well as
the number of overall inspections.
Mr. Stupak. Let me go to your next chart on page 12, again,
number of inspections per facility between 2004 and 2008. I
take it facilities inspected more than three times, there is 21
percent of them, were probably the greater or high-risk foods.
Ms. Nudelman. I am not positive about that. That makes
sense to me, but I am not--I can look at that in a little bit
more detail for you.
Mr. Stupak. All right.
Let me go to the bottom of page 14. In your report, you
were talking about the FDA OAI classifications--refused to
grant FDA officials access to their records. Most of the
facilities had a history of violations. Then you say the FDA
does not have statutory authority to require food facilities to
provide access to these records.
Do you know if the FDA ever received those records in these
four or five cases?
Ms. Nudelman. In the reports that we looked at, that was
for 2008, and it just documented clearly the types of records
that they did not receive. I don't know. And maybe FDA has a
better sense of that.
Mr. Stupak. Yes, I was going to ask Mr. Taylor.
Any comment on that? Do you know if they ever received
those records?
Mr. Taylor. We got what we felt was a satisfactory
resolution. Dr. Solomon can walk you through the details of
each one. It varied from case to case. But, in some cases, we
went ahead and got injunctions to solve the problem or took
other forms of enforcement action. And if you would like, we
can put----
Mr. Stupak. Sure. Just quickly, if you could just tell us
what would happen on those.
Mr. Solomon. In one of those cases, we actually used the
authority under the Bioterrorism Act, 414, to meet that
threshold to have to request those records. Obviously, that
delayed us.
In two of the other cases, we conducted an injunction in
order to try and get those records and requesting others for--
--
Mr. Stupak. Injunction would stop them from doing what,
shipping their product?
Mr. Solomon. We were able to stop them from shipping
product, and, at the same time, we used that consent decree
that was signed to go to the suppliers there and get the
information that we needed to control the product.
Mr. Stupak. OK. So you went to the supplier to find out
what the facility was doing?
Mr. Solomon. Correct.
Mr. Stupak. OK.
Mr. Solomon. So these were longer processes that took us to
try and get the records that were needed.
Mr. Stupak. Sure. OK.
My time is up. Mr. Burgess for questions?
Mr. Burgess. Just staying with that concept for a minute,
Mr. Taylor and Mr. Solomon, on the food safety bill that we
passed out of this committee that is now awaiting activity over
in the Senate, there is a provision for emergency recall, which
I think you referenced, Mr. Solomon, as part of the
bioterrorism defense. But, still, it is a voluntary recall
under the bill that we passed.
Is that your understanding, as well?
Mr. Solomon. We don't currently have mandatory recall
authority, which is part of the Food Safety Enhancement Act.
Mr. Burgess. And after the passage of this legislation, is
that a deficiency that you feel will be corrected? Or will you
still be relying on the emergency provisions of the
Bioterrorism Act to have that emergency provision?
Mr. Solomon. We could use all the tools available, and we
would use that mandatory recall authority if that was necessary
in order to effectuate getting product removed from the market.
Mr. Taylor. If I may add, the bill, 2749, would also give
us routine records access, so the company would be obligated to
provide the records we need to conduct an investigation and to
find and discover the problems and solve the problems.
Mr. Burgess. Mr. Taylor, congratulations on your new post--
--
Mr. Taylor. Thank you, sir.
Mr. Burgess [continuing]. I think, I hope, for you.
How many people currently work in your office?
Mr. Taylor. Well, in my immediate Office of Foods, it is a
very small staff of about 15 people. But we really work within
the overall foods program. There is the Center for Food Safety
and Applied Nutrition, the Center for Veterinary Medicine, and
then the large field force. So, you know, there are upwards of
5,000 people in the foods program.
But this new office that the commissioner created is a
small leadership office, essentially.
Mr. Burgess. OK. Do you plan on expanding it?
Mr. Taylor. The immediate office will grow slightly, but
the last thing we want to do is to try to manage the program
from the Office of Foods. We have great management teams and
people throughout the foods program and these organizations,
and our job is to lead and to unify and elevate their work
within the FDA.
Mr. Burgess. So, you just referenced the Center for
Veterinary Medicine. Those directors report to you, as well?
Mr. Taylor. Yes, sir. The director of the Center for
Veterinary Medicine reports to me, as does the director of the
Center for Food Safety and Applied Nutrition.
Mr. Burgess. At this point, are you considering merging the
Center for Food Safety as well as the Center for Veterinary
Medicine?
Mr. Taylor. We have no plans to merge the organizations. We
are looking at how we manage this program in a unified way and
how we can be sure that we are really able to empower the
people in these organizations to accomplish the things they are
setting out to accomplish. And so we are looking at how we
manage the program, but we have no plan for mergers at this
point.
Mr. Burgess. Let me just ask you a couple of questions
about PREDICT since that has come up in your testimony as well
as the testimony of the GAO. It holds promise, correct?
Mr. Taylor. Yes, sir.
Mr. Burgess. But there were problems.
Mr. Taylor. Yes.
Mr. Burgess. And those problems were related to the status
of the IT systems that are surrounding it?
Mr. Taylor. Yes, sir. Really--and I am not the IT expert on
the case, but it is really a function of the aging IT
infrastructure, the servers, the basic equipment that supports
the IT system.
And so what happened, in lay terms, is a combination of
things. You put this whole new application onto the system,
which put extra demand on the system. And it was happening at
about the time that we have grown our field workforce. We have
been able, with resources Congress has provided over the last
couple of years, to hire additional inspectors and other people
in our field force.
So that combination of extra demands on an aging IT
infrastructure resulted in slowdowns and some, you know,
servers going down. And the IT people realized that that aging
infrastructure could not support the new system.
But, again, with resources Congress has provided, we are
making the investments to upgrade that infrastructure. So, you
know, that upgrade and the imperative to test that carefully
and be sure that when we do implement--you know, that is
pushing back implementation. But we hope to roll out PREDICT
nationwide by the end of the year. That is our goal.
Mr. Burgess. You anticipated my question. But I was going
to ask you, you have developed a strategic plan for dealing
with the deficiencies in the IT architecture?
Mr. Taylor. Yes, sir. We have the--you know, upgrades are
being made; it is being tested. You know, we will test the
PREDICT system before we make it operational. But the IT folks
are confident that we will have the infrastructure to support
this and, you know, make it serve the function that we know it
can, which will really be much better targeting of imports.
Mr. Burgess. So when we have this hearing a year from now,
you will be able to report to me----
Mr. Taylor. I will be here, yes----
Mr. Burgess [continuing]. Satisfactorily that it has been
up and running for 6 months and it is targeted and in the right
place?
Mr. Taylor. That is our absolute aspiration and goal. We
are working hard to achieve it. And we welcome coming back and
giving that answer.
Mr. Burgess. You can understand the frustration of people
who--you know, we are requiring every physician's office across
the country to make great investments in information
technology, and our own FDA, which is our premiere Federal
agency that handles 25 cents out of every Federal dollar, at
least domestically, has been unable to meet its own challenge.
Clearly, we have to get our own house in order before we
can be too critical of other people who have been slow in that
regard, as well.
Mr. Taylor. I understand.
Mr. Burgess. I am going to yield back to the chairwoman.
Mrs. Christensen [presiding]. Thank you, Mr. Burgess.
The chair is now really honored to recognize our chairman
emeritus, Mr. Dingell, for questions.
Mr. Dingell. Thank you, Madam Chairman. I commend you for
the way you are presiding, and I thank you for being
recognized.
I want to begin by commending Chairman Stupak and the
committee for this hearing. And I want to observe that this
committee has completed a rather remarkable piece of
legislation with regard to food safety that rests comfortably
in the arms of the United States Senate. As my old daddy used
to say, that is the place where good legislation goes to die.
Regrettably, the points made by the witness on behalf of
the GAO are very much on point. Her observation of the two
statutory methods that need to be added to the arsenal of FDA
are included in that legislation.
I know this is going to sound a little hostile to the
panel, but I want to begin by commending--and I want you to
understand, there is nothing hostile in these questions. But I
want to lay the framework of understanding how the events about
which we are surrounded affect what it is we are doing.
And I will start by observing that FDA, in 2008, inspected
153 foreign food facilities out of 189,000 such facilities
registered with FDA. That is, of course, only a small fraction
of the, in fact, number of worldwide sources of foods imported
to the United States. But we were able, in each of those years,
according to GAO, to investigate only a very small number of
the massive numbers of exporters into the United States.
I noted, with regard to China, FDA conducted 46 inspections
to China. China is one of the biggest exporters of food to the
United States. I observe that that is a country which sends us
melamine in milk products, mushrooms, vegetables, fish,
shellfish, and other food products that are contaminated,
dirty, filthy, or adulterated.
And, frankly, again, the legislation to which we address
ourselves sits over there in the Senate. That is a remarkable
piece of legislation which came out of this committee
unanimously with the full support of every single Member. And
the leadership of this subcommittee made it possible for that
legislation to move because of the way Mr. Stupak and the
members of the committee, including my colleagues on the
minority side, worked very hard to see to it that this
legislation had not only a proper flooring and support but also
a full justification.
Now, having said these things, I would like to make a quick
observation and then a question.
Since 2007, FDA has had two major outbreaks linked to
peanut butter, involving hundreds of illnesses and nine deaths.
That is out of about the 5,000 deaths that exist in this
country.
And now I would like to address the types of enforcement
action that have been taken against the companies. I would note
that the GAO asserts that additional authority to routinely
inspect records, detain food, subject violators to civil
penalties, subpoena witnesses to help stepped-up enforcement
efforts would be significantly helpful.
Am I correct in that, to my witnesses down there,
particularly you, Commissioner, and you, ma'am, from the GAO?
Mr. Taylor. Yes, sir. Those new authorities are crucial to
our doing our job.
Mr. Dingell. Now, I note FDA's budget anticipates hiring
129 new food and safety inspectors based on revenue from the
registration and reinspection fees in H.R. 2749.
What will happen, if you please, to its plans to hire these
129 new inspectors if these fees are not included in the bill
that the President signs as they are in the budget?
Mr. Taylor. We won't be able to hire those inspectors. And,
you know, we need more inspections to ensure the safety of
food.
Mr. Dingell. That means that the ongoing record of dismal
ability to investigate or to inspect food processors will
continue unabated.
Mr. Taylor. Yes, sir.
Mr. Dingell. Now, I note that the Peanut Corporation of
America recall, while it was still ongoing, one of the
companies that received the PCA product, Westco Fruit and Nut
Company, refused FDA access to important safety records and
refused to conduct a voluntary recall, and FDA seized the
product of the company.
Now, I note that we should address--in that instance, Food
and Drug would be able, had the legislation been passed, to use
the mandatory recall authority to remove products that are
already on the market. Is that not so?
Mr. Taylor. Yes, sir, that is correct.
Mr. Dingell. Now, how would such mandatory recall authority
result in a different outcome in the Westco case?
Mr. Taylor. Well, we could have directed that firm to
recall that product, to stop distribution, withdraw the product
from the market. We wouldn't have to have been in a lengthy
discussion and then have to go to court and get a judicial
intervention. We could have acted swiftly with those----
Mr. Dingell. In other words, all of this sawing of the air
would have to go on while people were dying of bad peanut
butter.
Mr. Taylor. Again, if we are delayed in removing product
from the market, people are at risk.
Mr. Dingell. Now, following the outbreak in the recall
first linked to tomatoes and later to jalapeno and serrano
peppers, the inspector general identified weaknesses in the
current one-up/one-down traceability system, including bad
record-keeping, lack of access to records, and firms that
didn't know about the requirements.
Has FDA's experience in other outbreaks confirmed flaws in
the one-up/one-down traceability?
Mr. Taylor. Yes, sir. I mean, that requires a lot of shoe
leather by FDA. It is an old-fashioned paper system,
essentially, when we have electronic alternatives, systems that
the industry itself is developing, that can get us this
information much more quickly.
Mr. Dingell. Now, how important is trace-back in containing
food-borne illness outbreaks?
Mr. Taylor. Trace-back is crucial. Once CDC identifies the
food vehicle, we then need to be able to go back to the source
of production so we can get to the root of the problem and
contain it. So it is really crucial to public health, as well
as to protecting the industry, to contain a problem so that the
industry, its own business, won't be disrupted any more than
need be.
Mr. Dingell. You can protect honest men and women in the
industry from unfair competition by scoundrels and rascals, but
you would also protect them against unsafe materials that could
enter into the products that they distribute. Isn't that right?
Mr. Taylor. Yes, sir. That is exactly it.
Mr. Dingell. Now, in your report--this is to Ms. Shames. In
your report, you state CBP's computer system does not notify
FDA when imported food shipments arrive at U.S. ports. It is
extremely important that these two agencies coordinate when it
comes to imported food. Do you agree with that?
Ms. Shames. We agree. We have been able to update that
information, and CBP has told us that now it does give FDA the
time of arrival. And this should help FDA in terms of
coordinating its inspections.
Mr. Dingell. What additional steps need to be taken by the
administration to fully address this concern?
Ms. Shames. We feel that CBP should continue to work
towards this effort to share time-of-arrival information with
USDA. That part of our recommendation has not yet been
implemented.
Mr. Dingell. Thank you.
Madam Chairman, you have been most kind to me with regard
to the time. I yield back the balance.
Mrs. Christensen. Thank you, Mr. Chairman.
I now recognize myself for 5 minutes of questions. And I
want to ask a question about information sharing, as well.
Ms. Shames, I would like to ask you about GAO's finding
that FDA does not always share product distribution information
with State regulators during a recall. If food needs to be
removed, FDA may not give State regulators important
information like which grocery stores and warehouses received
the recalled product.
FDA's inadequate coordination with States means that States
must duplicate FDA's efforts and track down the same
information. You found that public health--and I guess this is
a quote--may be at risk during the time it takes for the States
to independently track distribution information when a product
is found to be contaminated.
So my question, Ms. Shames: FDA's limited provision of
information to States during an outbreak seems illogical, so
what is the agency's rationale for withholding that
information?
Ms. Shames. FDA says that this information is commercially
confidential. And while we recognize that, we still recognize
the public need that the State agencies are often the ones that
are actually going into the grocery stores and removing the
contaminated product off of the shelf. What we recommended to
FDA and what FDA agreed to is that they would explore ways to
try to get comparable information to the State agencies.
I should note that USDA, the Food Safety and Inspection
Service, does give product name information to the States as a
way of trying to expedite any recall.
Mrs. Christensen. OK.
So, Mr. Taylor, so you have agreed, and you have the
authority to share that information with the States?
Mr. Taylor. We are able to share this information with
State officers who are commissioned by FDA. And to some extent
around the country we have actually commissioned State
officials to function as FDA officials, so we are able to do it
to that extent. But we do have legal constraints under the laws
that govern disclosure of information.
This is a strong feature of the legislation, H.R. 2749,
that this committee has passed, that the House has passed,
because it would explicitly authorize us to share information
with State officials, with other organizations, when necessary
to protect public health, and still protecting the confidences
of companies but getting the information in the hands of people
who need it to protect public health. And we enthusiastically
embrace that. We need that clear authority from Congress.
Mrs. Christensen. OK. Thank you. You answered the rest of
my question.
My next question is on monetary bonds and civil penalties.
I am concerned that FDA may not have sufficient authority to
keep an importer from violating food safety requirements. Under
our current system, the importing company maintains control
over their food shipments but is not allowed to release them
until FDA approves. Importers post a monetary bond with Customs
and Border Protection to guarantee the product will meet all
U.S. Requirements, including those of FDA.
At least, that is how the system is supposed to work. But
the GAO investigation found that FDA and Customs and Border
Protection officials do not believe that the bonding system
stops import firms from releasing their goods prior to FDA
approval. GAO found that many brokers and importers expect that
they will occasionally have to forfeit the monetary bond as
part of the cost of doing business.
So, again, my question to you, Ms. Shames, is: Why is the
current system of monetary bonds not a sufficient deterrent?
Ms. Shames. What we are seeking is for FDA to be able to
assess the civil penalties, to make it more of a deterrent for
unscrupulous importers who try to do that.
Mrs. Christensen. Is the amount of the bond adequate as a
deterrent, or does it need to----
Ms. Shames. FDA and CBP officials told us that they thought
that the amount of the bond really was insufficient.
And this is something that we reported in an earlier report
back in 1998. So, well over a decade ago, we were hearing this
information from those agencies.
Mrs. Christensen. And your testimony stated that GAO
recommends that the FDA commissioner seek authority from
Congress to assess civil penalties. Can you elaborate? Why does
FDA need authority to assess the civil penalties?
Ms. Shames. Now it cannot do that; it relies on CBP for any
enforcement actions. And giving FDA this authority, again, we
feel, would be a deterrent for any unscrupulous importers.
Mrs. Christensen. So, Mr. Taylor, if FDA could impose civil
monetary penalties for violations of food safety requirements,
would that assist FDA in its mission?
Mr. Taylor. That would be a big help, to create more
accountability for importers.
There is another very important feature of the legislation,
though, that would require importers to register with us and to
meet requirements for their own practices in order to stay
registered, to stay in business as importers. So we would have
also the authority to de-register an importer.
So, again, it is critical that we enhance the
accountability of importers to play by the rules, essentially.
Mrs. Christensen. Is there authority needed to increase the
amount of the bond--well, that would be CBP.
Mr. Taylor. Right.
Mrs. Christensen. Yes. Thank you.
OK, I am out of time. So are we going to have a second--oh,
you are back.
I will recognize Mr. Burgess, Dr. Burgess, for a second
round of questioning.
Mr. Burgess. Thank you.
Mr. Taylor, approximately 13 million shipments of food
arrive in the U.S. Every year from foreign producers. And, of
course, the number is growing, as we have seen from all the
graphs.
There are numerous examples of foods that have been
problematic. We have heard about the melamine in the milk and
the problems with gluten and some of our pet food contamination
of a few years ago.
You have opened some stations overseas, the FDA has opened
some stations overseas. In addition to that--and the first
question is, have we opened enough? Have we done enough in that
regard?
And what other measures are we employing to increase or
enforce lax safety standards in other countries?
Mr. Taylor. Yes. You know, I think it is going to take a
combination of tools and efforts to ensure the safety of
imports.
Those foreign offices are--they are not inspection posts,
but they are critical posts for gathering intelligence about
what is happening in other countries, to explain our
requirements to foreign governments and to foreign firms.
But that is just one small piece of the toolkit. We do need
to do more inspections overseas, but we also need to hold the
importer accountable and see that they are policing their own
supply chain and being able to provide real assurances to us,
documented assurances, that they are producing products
overseas or sourcing their product from facilities that meet
our standards.
So it is going to take a combination of things. But it is
all about building more accountability into the supply chain,
all the way back to the point of production.
Mr. Burgess. And it would seem intuitive that the importer
would want that accountability in the supply chain, because,
after all, if their products are felt to be unsafe when they
get over here, their market share is going to suffer.
But is the FDA working with the importers directly in a
collaborative fashion, educational fashion, to try to get more
accountability on that end?
Mr. Taylor. We do work with the importer community. We have
issued guidance to the importer community on good importer
practices that we think they should observe to meet that
responsibility, to offer food only that meets our standards.
You know, some importers feel the accountability. They are
part of a supply chain. The major processor in this country
might be the importer, in some cases. But, in other cases,
importers don't have a stake in what happens to the food after
it passes from them, and so they lack accountability.
And so there is a real gap in the system, you know, if we
don't have systematic accountability on importers as a critical
part of the safety assurance system.
Mr. Burgess. So what can you do to impose that degree of
accountability if it may not exist naturally as part of the
marketplace?
Mr. Taylor. We need the passage of H.R. 2749. That is one
of the most critical elements of the legislation, to define
that accountability, to give us the authority to set the rules
that the importers need to play by in order to provide an
adequate assurance that the food that they are offering is
meeting our standards; again, backed up by our own ability to
go inspect, backed up by what foreign governments are doing,
backed up by a host of other checks.
But that importer accountability is really a linchpin of
the system. And it is lacking now as a really enforceable
matter. It is something we urge on the industry, but there is
no legal requirement for the importer to really take that
responsibility. They only run the risk that we will send the
food back. Or, you know, they may get it into the country under
a bond, and, as a cost of doing business, you know, some of
them, unscrupulous, will make a decision to let the product go.
So there is a lack of accountability in that part of the
system that H.R. 2749 would directly address.
Mr. Burgess. I have always felt that it really is necessary
to have some sort of a stop button that you guys can push in a
hurry if you need to, if we find that we have something coming
in that we really shouldn't.
Ms. Nudelman, let me just ask you a question. And I
apologize if Chairman Stupak has already covered this. But, in
the report, it found in fiscal year 2007 the FDA took no
regulatory action for 25 percent of facilities who received the
OAI classification.
Why would the FDA classify a facility as ``official action
indicated'' rather than one of the lesser classifications and
then take no action? What would be a possible--that seems
counterintuitive to me. What would be a possible rationale for
doing that?
Ms. Nudelman. Well, in some cases, if the facility agreed
to take action or promised to take action, then they did not
issue--they did not take any further regulatory action. That
was the most common response that we heard.
Mr. Burgess. And then how is the follow-up for that
overseen to ensure that, indeed, the voluntary action was taken
and the problem was corrected?
Ms. Nudelman. Well, that is one of the things we found. In
about 36 percent of the facilities, FDA didn't take any--didn't
reinspect to ensure that the correction was made or look at any
other evidence. So there is not always the follow-up.
Mr. Burgess. So that is still inherently a weak spot that
needs to be fixed.
Ms. Nudelman. Correct.
Mr. Burgess. Thank you, Mr. Chairman. I will yield back.
Mr. Stupak [presiding]. Mr. Dingell, did you have a
question or two on this second round here, please?
Mr. Dingell. Mr. Chairman, I will impose again briefly upon
your patience. And I want to thank for your courtesy to me. And
I also want to commend you for the series of hearings you have
held on these matters, because they have made it possible for
us to move forward in a very significant fashion to protect
people and to see that Food and Drug finally has the law and
the resources it needs to do its business.
Now, these questions are for Ms. Nudelman. There are
226,373 foreign food facilities registered with FDA. When the
inspector general looked at the domestic facilities registered
in 2009, it found 48 percent provide inaccurate information; 7
percent either fail to register or failed to cancel their
registrations; and 5 percent created multiple registrations.
Now, if domestic registrations are this prone to errors, in
your opinion, how reliable is the list of foreign facility
registrations?
Ms. Nudelman. The numbers that you cite are right on, and
it would make--I think it is even more challenging for foreign
facilities to have accurate information in the registry.
Mr. Dingell. Now, what can be done to help FDA improve the
accuracy of its registration lists? Obviously, more people;
obviously, more money; obviously, more inspections; obviously,
a better computer system.
Do they need, in addition to that, additional authority
under law to do the things that need to be done, to induce
better cooperation from the people who are supposed to
register? What has to be done, in your expert opinion?
Ms. Nudelman. I think there is a number of ways FDA can
improve the accuracy and the completeness of the information in
the registry. We make a recommendation to FDA to consider
seeking the authority to have facilities register on a more
routine basis. And that would allow the facilities to provide
updated information about the foods they handle and about
contact information.
Mr. Dingell. Thank you.
Now, Mr. Taylor, do you have a comment you would like to
make?
Mr. Taylor. Well, I think that suggestion that Ms. Nudelman
made is an excellent one. I think the requirement to have a
unique identifier is important. And I think the requirement for
the importer, as part of good importer practices, to be able to
vouch for the accuracy of the information, identifying the
foreign sources of supply, the foreign facilities from which
they are sourcing products for import--all of those, I think,
would really improve the reliability of the registration list.
And those are all addressed in the Food Safety Enhancement Act.
Mr. Dingell. Now, Ms. Shames, you have talked about the
ability to inspect. And, in your very excellent study, you
talked about the need for FDA to be able to do a better job of
getting the cooperation of Homeland Security and other
government agencies.
How could that best be done? Could that best be done by
having a memorandum of agreement between the agencies, a
memorandum of agreement required by congressional action, or by
some other mechanism whereby we could see to it that these two
very important agencies, or several very important agencies,
talk to each other so that they are able to use the advantages
that comes with having several different agencies enforcing
different laws but able to work together to address the
problems that concern us?
Now, what is your comment, please?
Ms. Shames. It will be a multifaceted solution to a very
complicated problem, and I wish I could tell you that there
will be a single step that could correct that. We found that at
the working level that the relationships between FDA and CBP
were oftentimes very cordial, that they were able to work
around, for example, not getting the time of arrival
information.
Mr. Dingell. Of course, that is a structural failure, is it
not?
Ms. Shames. Well, yes, in this case it was.
Mr. Dingell. And whose fault is that, the other agency or
is that the importer or the food broker or who?
Ms. Shames. Well, there are many players that are involved
in the oversight of food safety. FDA is one, and, as you noted,
CBP really is the first face for an importer. So one of the
challenges that we identified is CBP's own computer system,
that that system----
Mr. Dingell. And that's probably hopelessly out of date, as
is the Social Security computer system.
Ms. Shames. Well, there are hardware changes that would
have to be made, for example, for getting a unique identifier.
This is something that FDA feels it needs. We have certainly
identified that it's something that is very important, but CBP
told us that it would be difficult for its current system to do
it, and they really could not offer any sort of timeline of
when that might be done.
So it's structural in terms of the many agencies that are
involved, but it also gets to the resources in terms of, you
know, the computer systems that it has in place as well as the
people.
Mr. Dingell. Thank you. Mr. Chairman, again, thank you for
your courtesy to me, and I want to remind everybody that you
and this subcommittee have had tremendous leadership in this
matter. I want to remind everybody that this committee, working
unanimously, together in a bipartisan fashion, has set out
legislation that would address the problems we now discuss
today, which reside comfortably in the United States Senate.
Thank you, Mr. Chairman.
Mr. Stupak. Well, hopefully the Senate will move that
legislation, get it to conference, and we can go from there.
Let me ask, Ms. Shames, about the unique identifier. How
can one firm have 75 different identifiers?
Ms. Shames. It can happen very inadvertently, when a
company registers for an import shipment, it may identify
itself one time as White, Incorporated. The second time the
company might identify itself as White Company. So it is
something that is done most of the time, very innocently, but
it means that there needs to be some sort of scrubbing of the
list to make sure that each company has a single----
Mr. Stupak. So the company enters its information on a
computer Web site so it is really the company that enters it,
which would then give it a number----
Ms. Shames. That's right.
Mr. Stupak [continuing]. Which could be unique on something
as simple as an address, a different address.
Ms. Shames. Yes.
Mr. Stupak. Does Customs and Border Patrol use unique
identifiers?
Ms. Shames. They do not, no. They also----
Mr. Stupak. Shouldn't they actually have access to it at
the same time? Shouldn't that company give it to Customs and
Border?
Ms. Shames. Ideally FDA and CBP and would have the same
unique identifier.
Mr. Stupak. Ideally, but reality is they don't, right?
Ms. Shames. Right.
Mr. Stupak. If we would limit the number of ports that food
could be imported into this country, would that help?
Ms. Shames. Well, that is an approach that USDA takes.
Mr. Stupak. Right, on meat products.
Ms. Shames. Well, that only USDA regulated imports come
from food systems that have or are equivalent to ours, only
through designated ports. USDA also goes and audits those
countries to make sure that their systems are comparable or
equivalent.
Mr. Stupak. Well, is that something we should look at? I
was going back to your chart number one that you had in here,
you know, you said 80 percent of our seafood comes from foreign
sources, I think she said 60 percent of our fruits and
vegetables. And they can come into basically any airport or any
trucking location on our border,correct?
Ms. Shames. That's true, yes. Stakeholders that we have
spoken to said that it would be difficult for FDA to really
replicate the same system that USDA has, because----
Mr. Stupak. I am not saying replicate it, but shouldn't you
limit the ports of entry? I mean, how can you control anything
if every airport and every truck crossing is basically a port
of entry for food or seafood?
Ms. Shames. Well, it's an approach that the European Union
has taken to limit the ports for its risk-based foods, so it
is--there are precedents for it.
Mr. Stupak. Any comments on that, Mr. Taylor, on either
unique identifiers or limit the number of ports?
Mr. Taylor. Yes. Again, from a consistent--an ease of
implementation by the regulatory agency, that's certainly
advantages to that. I think the challenge we face that is
different from the USDA is that, you know, we are dealing with
a much larger array of commodities coming from a much larger
volume of countries, there's a huge volume of trade.
And so I think there would be, you know, big practical
questions you would have to work through. I don't think anyone
wants to disrupt the trade in food, but we need to be sure it's
safe. And how do you do that? It's a really important question.
Mr. Stupak. Let me ask you this then, Mr. Taylor, you
mentioned the shipper's bond. What is the usual amount of a
bond? Does it depend on the product and the value?
Mr. Taylor. Typically three times the value of the
shipment.
Mr. Stupak. OK. You said many times the shipper will just
forego the bond.
Mr. Taylor. Again, our understanding is that some shippers,
you know, who have a large volume of business are willing to
just take that chance of letting a product go out into
commerce, even though it's still under bond, because, you know,
in the whole course of their business they don't get caught
very often or they aren't--there's not a problem that requires
that that product be brought back. And so, again, it's the cost
of doing business for some of these firms.
Mr. Stupak. Well, should we make it higher?
Mr. Taylor. I think you could try a higher bond. I mean, I
think the civil penalty approach is one part of it. I think the
importer accountability and the fact that an importer could
lose its registration under the Food Safety Enhancement Act
would be perhaps even stronger tools, you know, to make them
have really something really at stake for playing by the rules.
That's what we need to do.
Mr. Stupak. You know, Mr. Dingell pointed out, and I think
we have all pointed out that, you know, it's expensive to keep
our food supply safe and the agency needs inspectors, and I
think GAO report says, what, $16,000 per inspection at a food
facility. And the IG said that, and I am quoting now, The
decline in inspection is largely due to the significant decline
in staffing level that resulted from cuts.
And in the legislation that we have pending in the Senate,
the Food Safety Enhancement Act, we have an annual registration
fee of $500. These fees would be devoted towards funding a
variety of food safety activities. Any idea and what percentage
would go towards inspectors?
Mr. Taylor. Well, we would envision the fee revenue being
used to a significant degree to meet the inspection mandates,
or to at least contribute to meeting the inspection mandates in
the legislation. But we also have to invest those resources in
the tools for the inspectors and the scientific basis for what
they are doing, so it would be a mix of activities. And you
could also contribute to the import oversight.
So we would distribute it across a mix of activities to
meet the objectives of the statute.
Mr. Stupak. Well, under the Obama administration, did you
not receive a substantial increase in money for food safety in
the last year?
Mr. Taylor. The 2010 budget is, yes, is an increase over
2009, and there's an increase requested in 2011.
Mr. Stupak. Well, have you hired more inspectors?
Mr. Taylor. Yes, sir, the last 2 or 3 years of funding has
enabled our field force to add 6- or 700 inspectors, who are
completing their training, and we are going to be able to
increase our inspections because of that in the coming years.
So there has been that step up, you know, through the increases
we have gotten. It's not sufficient to meet the inspection
mandate in the legislation, but it's a step in the right
direction, which we appreciate.
Mr. Stupak. OK. Mr. Burgess, any questions?
Mr. Burgess. Yes. Just following up on that last line from
Mr. Stupak about the budget, did you, did the FDA receive any
money from the stimulus bill or the big health care bill that
we just passed?
Mr. Taylor. No--there was some money that went into HHS for
management matters related to FDA like comparative
effectiveness of pharmaceuticals, but there was not money that
directly affects the food program.
Mr. Burgess. Did the Obama administration seek funding for
the FDA in either one of these laws?
Mr. Taylor. Well, again, the stimulus money was about
immediate projects that could stimulate economic activity in
the near term and so that we----
Mr. Burgess. Mr. Taylor, we gave $10 billion to NIH. Are
you any less deserving than they are?
Mr. Taylor. We would never say----
Mr. Burgess. $10 billion to NIH. Now I love the guys at
NIH, but you are important too.
Mr. Taylor. Yes, sir, we agree with you.
Mr. Burgess. Well, do you know why the administration
didn't ask for additional funding for the FDA in either of
these laws?
Mr. Taylor. I would have to get back to you on that. I
don't personally--I wasn't involved in that.
Mr. Burgess. Well, and it's all well and good, just like
the Obama budget, and what great things are going to happen as
a result of it, but we are not going to pass a budget on the
floor of this House I don't think, unless Mr. Stupak knows
something that I don't know----
Mr. Stupak. It wouldn't be first time getting me wrong on
legislation.
Mr. Burgess. And certainly, we are not going to do any
appropriations bills before election day, so your level of
funding till some omnibus in the lame duck session, so are you
oK with that level of funding at this point?
Mr. Taylor. Well, again, we are going to need additional
resources to carry out the expectations of the Food Safety
Enhancement Act. Again, that's why the fee provision and that--
the registration fee provision in that law, that bill is very
important to us. We do need a stable, predictable and adequate
level of resources to meet the mandates in the legislation.
Mr. Burgess. Well, and I couldn't agree with you more and
that a stable, predictable source of funds is not just true for
you but true other agencies as well, but so far we seem to be
doing things in fits and starts. And you, in fact, got left out
of the fits and starts, unfortunately.
Mr. Chairman, you have been very indulgent. It has been a
long day. I am going to yield back the balance of my time.
Mr. Stupak. Thanks, Mr. Burgess. And as Mr. Dingell has
pointed out, you know, the Food Safety Act went through this
committee 51-0, and we appreciate our colleagues on the
Republican side of the aisle to help us provide a stable
funding source for that FDA through that $500 per facility
registration fee. That will provide the stable funding so we do
have the resources to get to it.
It's not just resources it's, information sharing. And
hopefully we can do that whether it's Customs and Border Patrol
or we get the PREDICT program worked out a little more so the
high risk foods we can identify.
Well, thank you and thank you to all of our witnesses.
Sorry about the delay there on the floor for a while. We
appreciate you staying with us and being here today.
That concludes all questioning. I want to thank all of our
witnesses for coming today and thank you for your testimony.
The rules of the committee provide that members have 10 days to
submit additional questions for the record. That concludes our
hearing. This meeting of the subcommittee is adjourned.
[Whereupon, at 4:58 p.m., the subcommittee was adjourned.]
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