[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]
EXAMINING THE IMPLEMENTATION OF THE FOOD SAFETY MODERNIZATION ACT
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED THIRTEENTH CONGRESS
SECOND SESSION
__________
FEBRUARY 5, 2014
__________
Serial No. 113-116
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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COMMITTEE ON ENERGY AND COMMERCE
FRED UPTON, Michigan
Chairman
RALPH M. HALL, Texas HENRY A. WAXMAN, California
JOE BARTON, Texas Ranking Member
Chairman Emeritus JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky FRANK PALLONE, Jr., New Jersey
JOHN SHIMKUS, Illinois BOBBY L. RUSH, Illinois
JOSEPH R. PITTS, Pennsylvania ANNA G. ESHOO, California
GREG WALDEN, Oregon ELIOT L. ENGEL, New York
LEE TERRY, Nebraska GENE GREEN, Texas
MIKE ROGERS, Michigan DIANA DeGETTE, Colorado
TIM MURPHY, Pennsylvania LOIS CAPPS, California
MICHAEL C. BURGESS, Texas MICHAEL F. DOYLE, Pennsylvania
MARSHA BLACKBURN, Tennessee JANICE D. SCHAKOWSKY, Illinois
Vice Chairman JIM MATHESON, Utah
PHIL GINGREY, Georgia G.K. BUTTERFIELD, North Carolina
STEVE SCALISE, Louisiana JOHN BARROW, Georgia
ROBERT E. LATTA, Ohio DORIS O. MATSUI, California
CATHY McMORRIS RODGERS, Washington DONNA M. CHRISTENSEN, Virgin
GREGG HARPER, Mississippi Islands
LEONARD LANCE, New Jersey KATHY CASTOR, Florida
BILL CASSIDY, Louisiana JOHN P. SARBANES, Maryland
BRETT GUTHRIE, Kentucky JERRY McNERNEY, California
PETE OLSON, Texas BRUCE L. BRALEY, Iowa
DAVID B. McKINLEY, West Virginia PETER WELCH, Vermont
CORY GARDNER, Colorado BEN RAY LUJAN, New Mexico
MIKE POMPEO, Kansas PAUL TONKO, New York
ADAM KINZINGER, Illinois JOHN A. YARMUTH, Kentucky
H. MORGAN GRIFFITH, Virginia
GUS M. BILIRAKIS, Florida
BILL JOHNSON, Ohio
BILLY LONG, Missouri
RENEE L. ELLMERS, North Carolina
_____
Subcommittee on Health
JOSEPH R. PITTS, Pennsylvania
Chairman
MICHAEL C. BURGESS, Texas FRANK PALLONE, Jr., New Jersey
Vice Chairman Ranking Member
ED WHITFIELD, Kentucky JOHN D. DINGELL, Michigan
JOHN SHIMKUS, Illinois ELIOT L. ENGEL, New York
MIKE ROGERS, Michigan LOIS CAPPS, California
TIM MURPHY, Pennsylvania JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee JIM MATHESON, Utah
PHIL GINGREY, Georgia GENE GREEN, Texas
CATHY McMORRIS RODGERS, Washington G.K. BUTTERFIELD, North Carolina
LEONARD LANCE, New Jersey JOHN BARROW, Georgia
BILL CASSIDY, Louisiana DONNA M. CHRISTENSEN, Virgin
BRETT GUTHRIE, Kentucky Islands
H. MORGAN GRIFFITH, Virginia KATHY CASTOR, Florida
GUS M. BILIRAKIS, Florida JOHN P. SARBANES, Maryland
RENEE L. ELLMERS, North Carolina HENRY A. WAXMAN, California (ex
JOE BARTON, Texas officio)
FRED UPTON, Michigan (ex officio)
(ii)
C O N T E N T S
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Page
Hon. Joseph R. Pitts, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 1
Prepared statement........................................... 2
Hon. Marsha Blackburn, a Representative in Congress from the
State of Tennessee, opening statement.......................... 3
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 4
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 5
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 6
Hon. Fred Upton, a Representative in Congress from the State of
Michigan, prepared statement................................... 56
Witnesses
Michael R. Taylor, Deputy Commissioner for Foods and Veterinary
Medicine, Food and Drug Administration, Department of Health &
Human Services................................................. 7
Prepared statement........................................... 11
Answers to submitted questions............................... 58
EXAMINING THE IMPLEMENTATION OF THE FOOD SAFETY MODERNIZATION ACT
----------
WEDNESDAY, FEBRUARY 5, 2014
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:00 a.m., in
room 2322 of the Rayburn House Office Building, Hon. Joe Pitts
(chairman of the subcommittee) presiding.
Members present: Representatives Pitts, Burgess, Shimkus,
Murphy, Blackburn, Gingrey, Lance, Guthrie, Griffith,
Bilirakis, Ellmers, Walden, Barton, Upton (ex officio),
Pallone, Dingell, Capps, Matheson, Green, Butterfield, Barrow,
Christensen, and Waxman (ex officio).
Staff present: Matt Bravo, Professional Staff Member;
Noelle Clemente, Press Secretary; Brad Grantz, Policy
Coordinator, Oversight and Investigations; Sydne Harwick,
Legislative Clerk; Carly McWilliams, Professional Staff Member,
Health; Chris Sarley, Policy Coordinator, Environment and the
Economy; John Stone, Counsel, Health; Ziky Ababiya, Democratic
Staff Assistant; Eric Flamm, Democratic FDA Detailee; Elizabeth
Letter, Democratic Assistant Press Secretary; and Karen Nelson,
Democratic Deputy Staff Director, Health.
Mr. Pitts. The Chair will recognize himself for an opening
statement.
OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
According to the Centers for Disease Control, 48 million
Americans, or one in six, will become ill from a foodborne
disease each year. One hundred and twenty-eight thousand people
will require hospitalization, and 3,000 will lose their lives
as a result. Sadly, many of these diseases and deaths could
have been prevented if proper safety precautions had taken
place on the farm, in processing facilities, and while
transporting foods.
The Food Safety Modernization Act (FSMA), the most far-
reaching reform of the Food and Drug Administration's food
safety authority since the 1930s, was signed into law in
January 2011. The law tasked FDA with issuing major regulations
covering such topics as preventative controls for human food
and animal feed, produce safety, foreign supplier verification,
accreditation of third-party auditors, intentional
adulteration, and sanitary transportation, among others.
I am particularly interested in the sanitary transportation
proposal released last Friday. Since mid-2011, I have been
following stories about commercial food trucks without proper
refrigeration carrying perishable foods along our Nation's
highways at dangerously high temperatures, and a subsequent
investigation by the Indiana State Police. Perhaps Deputy
Commissioner Taylor can speak to how the proposed rule would
address situations like this.
I would like to commend Mr. Taylor for his outreach efforts
and dialogue with all parts of the food supply chain prior to
the release of these proposed rules and also for extending
comment periods on issues unique to certain sectors of the
industry, such as farmers. This conversation must continue.
I believe the success of FSMA's implementation will rest on
a flexible regulatory structure that, one, encourages an
efficient, risk-based approach to food safety, and two,
acknowledges that a one-size-fits-all, overly burdensome model
simply will not fit such a vast and diverse food supply chain
such as ours.
In issuing its proposed regulations, FDA has released
compliance cost estimates that differ significantly with
outside estimates, and I would be interested in learning about
the assumptions and methodology the agency used to arrive at
these figures.
Additionally, over the last few years, many parts of the
food industry have voluntarily made progress toward preventing
foodborne illness, and I would hope FDA would not punish these
good actors as it seeks to bring the rest of the industry up to
standard.
I would also ask Mr. Taylor for a commitment to work with
industry, particularly with respect to inspections, after the
final regulations go into effect. A collaborative, rather than
adversarial, relationship with industry will yield greater
compliance and ultimately further our goal of making the U.S.
food supply the safest it can be.
Finally, while we need to finalize FSMA's regulations in a
timely manner, I am concerned by the court-ordered deadline of
June 30, 2015. These regulations are too important to be rushed
through without proper thought and consideration.
I would like to welcome Mr. Taylor and thank him for
appearing before us today. I look forward to his testimony.
[The prepared statement of Mr. Pitts follows:]
Prepared statement of Hon. Joseph R. Pitts
According to the Centers for Disease Control, 48 million
Americans (or one in six) will become ill from a foodborne
disease each year. One hundred twenty-eight thousand people
will require hospitalization, and 3,000 will lose their lives
as a result.
Sadly, many of these diseases and deaths could have been
prevented if proper safety precautions had taken place on the
farm, in processing facilities, and while transporting foods.
The Food Safety Modernization Act (FSMA), the most far-
reaching reform of the Food and Drug Administration's food
safety authority since the 1930s, was signed into law in
January 2011.
The law tasked FDA with issuing major regulations covering
such topics as preventative controls for human food and animal
feed, produce safety, foreign supplier verification,
accreditation of third party auditors, intentional
adulteration, and sanitary transportation, among others.
I am particularly interested in the sanitary transportation
proposal, released last Friday. Since mid-2011, I've been
following stories about commercial food trucks--without proper
refrigeration--carrying perishable foods along our Nation's
highways at dangerously high temperatures, and a subsequent
investigation by the Indiana State Police.
Perhaps Deputy Commissioner Taylor can speak to how the
proposed rule would address situations like this.
I would like to commend Mr. Taylor for his outreach efforts
and dialogue with all parts of the food supply chain prior to
the release of these proposed rules and also for extending
comment periods on issues unique to certain sectors of the
industry, such as farmers. This conversation must continue.
I believe the success of FSMA's implementation will rest on
a flexible regulatory structure that (1) encourages an
efficient, risk-based approach to food safety, and (2)
acknowledges that a one-size-fits-all, overly burdensome model
simply will not fit such a vast and diverse food supply chain
such as ours.
In issuing its proposed regulations, FDA has released
compliance cost estimates that differ significantly with
outside estimates, and I would be interested in learning about
the assumptions and methodology the agency used to arrive at
these figures.
Additionally, over the last few years, many parts of the
food industry have voluntarily made progress toward preventing
foodborne illness, and I would hope FDA would not punish these
good actors as it seeks to bring the rest of the industry up to
standard.
I would also ask Mr. Taylor for a commitment to work with
industry--particularly with respect to inspections--after the
final regulations go into effect. A collaborative, rather than
adversarial, relationship with industry will yield greater
compliance and ultimately further our goal of making the U.S.
food supply the safest it can be.
Finally, while we need to finalize FSMA regulations in a
timely manner, I am concerned by the court-ordered deadline of
June 30, 2015. These regulations are too important to be rushed
through without proper thought and consideration.
I would like to welcome Mr. Taylor and thank him for
appearing before us today, and I look forward to his testimony.
Mr. Pitts. At this time I will yield the remainder of my
time to Ms. Blackburn.
OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TENNESSEE
Mrs. Blackburn. And we do welcome you and are pleased that
you are here. Thank you so much for taking the time to be here
and for giving us the opportunity to talk with you and look at
the FSMA and a look at food safety and the FDA and the
responsibilities that exist by regulations, the guidance
documents that affect the wide array of individuals and
industries that are associated with our Nation's food supply.
Everyone wants a secure food supply, and they don't want it to
be burdensome and cumbersome and difficult, and they want some
certainty in the process.
Since January 2013, the agency has issued a number of
proposed rules and received a significant amount and number of
comments. We hope we have the opportunity to review some of
this with you today and look forward to making certain that we
are all moving in the right direction for food security.
I yield back.
Mr. Pitts. The Chair thanks the gentlelady and now
recognizes the ranking member, Mr. Pallone, for 5 minutes.
OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. Thank you, Chairman Pitts, and thank you, Mr.
Taylor, for being here today.
I appreciate the opportunity to check in with the Food and
Drug Administration on its implementation of the FDA Food
Safety Modernization Act, or FSMA. With the passage of FSMA 3
years ago, Congress gave FDA new tools to shift the food safety
system from one that reacts and responds to food safety
incidents to one that prevents them.
FSMA provided the first major overhaul of Federal food
safety laws since the 1930s, and it was enacted at a time when
the public health challenges of an evolving domestic and global
food supply chain were evident in a series of foodborne illness
outbreaks and contamination incidents, and I am proud to have
worked with my colleagues, Mr. Dingell and Mr. Waxman and Ms.
DeGette, on food safety legislation that emphasizes a
prevention and risk-based approach to food safety from farm to
table, both for domestic and imported food, and ultimately to
have supported the passage of FSMA. Food safety is and should
be a bipartisan issue, and I hope we in this committee will
continue to do what we can to support progress in the
modernization of our food safety system.
We have seen in the last year the rollout of many
significant parts of the law, including proposed rules for
major framework elements such as produce safety standards,
preventive controls, and oversight of food imports. I
appreciate the work FDA has done in engaging with stakeholders
and incorporating public input into the development of these
proposed rules. However, I continue to urge FDA to enact final
FSMA rules as expeditiously as possible because the safety of
U.S. consumers' food supply should not be put at risk.
In addition, the passage of FSMA did not end our work on
protecting the public health from foodborne threats. There are
48 million Americans every year who get sick from foodborne
illnesses, as estimated by the Centers for Disease Control and
Prevention, and there are still several thousand deaths each
year attributed to foodborne disease.
In order to ensure that the safety benefits of FSMA will be
fully realized, Congress must provide adequate resources to the
FDA for implementation. The Congressional Budget Office
estimated that the law could require $1.4 billion over 5 years
to roll out, but the agency has received only a fraction of
that in resource increases, not to mention the impacts of
sequester.
The food import user fee and food facility registration and
inspection user fee proposed in the President's budget could
also substantially support the implementation of the modern,
effective food safety system envisioned in FSMA. I support the
idea of utilizing such food-related user fees, which I believe
can benefit both industry and government by reducing foodborne
illnesses and the associated costs, which can be significant.
The estimated overall economic total of outbreaks is almost $80
billion annually.
With the health and safety of the American public at risk,
we can't leave the job only half done by not adequately funding
FDA to fully implement this important law.
And again, thank you, Mr. Chairman, and I yield back.
Mr. Pitts. The Chair thanks the gentleman and now
recognizes the vice chairman of the subcommittee, Dr. Burgess,
5 minutes for an opening statement.
OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS
Mr. Burgess. Well, thank you, Mr. Chairman, and I
appreciate, Mr. Taylor, you being here with us this morning and
your willingness to discuss the implementation of the Food
Safety Modernization Act and the shifting focus of food safety
from reaction to prevention.
I must say, I am concerned that some of the rhetoric and
initial goals for the process have not been matched by the
proposed rules that have been released. The Food and Drug
Administration did have substantial interaction with
stakeholders initially but it seems that the rulemaking process
was only prompted to completion by actions in the courts.
Therefore, I am concerned that stakeholder comments were not
adequately addressed in the proposed rulemaking. We should
encourage the Food and Drug Administration to implement the
Food Safety Modernization Act through a scientific and risk-
based approach that addresses the needs and concerns of the
companies that the laws affect.
Many companies and industries in the food supply system
have been proactive and have implemented innovative
methodologies to address the changing landscape of the food
supply system. Companies should continue to identify
microbiological and chemical hazards and implement preventive
controls to effectively mitigate risk. We should promote an
environment that encourages innovation and moves away from a
one-size-fits-all regulation. And let me just say, as we sit
here now over 3 years since the Food Safety Modernization Act
was signed into law, I think it is significant that we are
having this meeting, this hearing in February of this year.
Look, we all know what is going to happen when the weather
heats up. We are going to have an outbreak. I don't know of
what. I don't know where it will occur. But you have seen it, I
have seen it through several years on this committee. We will
be talking about salmonella, we will be talking about E. coli.
I would like to know what is going to be different this year
than has happened in previous years. What are you doing
proactively with the new tools you have in the Food Safety
Modernization Act that are going to allow us to perhaps predict
and prevent but at least mitigate the damage from these
outbreaks that we all know will occur. And Mr. Pallone talked
about the fact that the Food Safety Modernization Act was
necessary, the first time it had been undertaken in decades. It
was necessary because of the evolving nature of the global risk
that was presented to our food supply, and as a consequence we
both know that that evolving of the global risk has not
changed. It has not diminished since the signing into law of
the Food Safety Modernization Act. So if anything, it is even
more critical this February than it was five Februarys ago or
10 Februarys ago. Our food supply system varies greatly across
the United States. Certainly, a one-size-fits-all approach
cannot address the needs of U.S. food suppliers effectively. I
hope we can continue to work with your agency and the
stakeholders to ensure that the food supply system has the
flexibility needed to allow the industry to tailor their
programs to their unique product needs while also ensuring the
highest food safety benefits for all consumers.
Thank you, Mr. Chairman, for the recognition. I will yield
back to you.
Mr. Pitts. The Chair thanks the gentleman and now recognize
the ranking member of the full committee, Mr. Waxman, for 5
minutes for an opening statement.
OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mr. Waxman. Thank you very much, Mr. Chairman.
In December 2010, Congress passed the most significant
overhaul of FDA's oversight of food safety since passage of the
Food, Drug, and Cosmetic Act in 1938. The FDA Food Safety
Modernization Act, FSMA, we call it, represents a fundamental
shift in how FDA approaches food safety, focusing on prevention
instead of reaction.
It requires food facilities to develop procedures to
prevent food contamination and to take corrective actions when
contamination is discovered. It requires FDA to establish
standards for the safe production and harvesting of fruits and
vegetables. It mandates increased FDA inspections for both
domestic and foreign facilities and gives FDA access to records
relating to food safety. It gives FDA mandatory recall
authority and improves its ability to detain unsafe food, and
it gives FDA better tools to oversee the safety of imports. It
encourages FDA to work with other Federal, State, local, and
foreign agencies to more efficiently achieve food safety goals.
It is an ambitious law, even just on an administrative
level. It requires FDA to prepare more than 50 regulations,
guidances, reports, and studies in a short timeframe. Already,
FDA has published proposed versions of the seven most important
regulations. Given their complexity, their need to fit together
and complement each other, and the breadth of their reach,
these regulations were not easy to develop. Their release is an
accomplishment for which FDA should be proud.
But now, of course, FDA must finalize them. I recognize the
political pressure put on the agency to delay and re-propose. I
also recognize the importance of ensuring that the regulations
are workable and that they appropriately address the wide range
of activities that they cover. But American consumers need FDA
to act without further delay.
We all have heard the statistics. According to the Centers
for Disease Control, every year 48 million Americans get sick,
128,000 are hospitalized, and 3,000 die from foodborne
diseases. The goal of the law is to substantially lower those
numbers. American consumers will not get its full benefits
until the rules are all finalized, and that is why FDA needs to
finalize them as quickly as the agency can.
Mr. Chairman, I thank you for holding this hearing. It will
be good to get an update from FDA on how the implementation of
this extensive legislation is going. I hope FDA will also share
with us the impact the current lack of user fees is having, or
is likely to have, on its ability to fully implement the law
and protect public health. I would prefer that we fully fund
FDA through appropriations. However in today's political
environment, that is not going to happen.
Enhancing food safety is in everyone's interest,
Republicans and Democrats, consumers, farmers, and
manufacturers. We should be doing everything we can to give FDA
the resources it needs to make full use of its new authorities
under the Food Safety Modernization Act.
Mr. Chairman, I look forward to the testimony. I want to
apologize in advance. There is another subcommittee meeting
simultaneously with this one, and I may not be here for the
full opportunity to hear the testimony. I will try to get back
for questions.
I yield back the balance of my time.
Mr. Pitts. The Chair thanks the gentleman.
On our panel today, we have Mr. Michael Taylor, Deputy
Commissioner, Food and Veterinary Medicine, U.S. Food and Drug
Administration. Thank you for coming. Your written testimony
will be made part of the record. You will have 5 minutes to
summarize.
At this time, the Chair recognizes Mr. Taylor for 5 minutes
for an opening statement.
STATEMENT OF MICHAEL R. TAYLOR, DEPUTY COMMISSIONER FOR FOODS
AND VETERINARY MEDICINE, FOOD AND DRUG ADMINISTRATION,
DEPARTMENT OF HEALTH & HUMAN SERVICES
Mr. Taylor. Thank you very much, Mr. Chairman, and good
morning, Chairman Pitts, Ranking Member Pallone and members of
the subcommittee, and first thank you for convening this
hearing and giving us an opportunity to discuss the
implementation of the Food Safety Modernization Act.
As you know, food safety is a fundamental public health
concern and it is a topic on which the public does have high
expectations, and unfortunately, as many of you have noted
already, too many Americans get sick every year, too many go to
the hospital and too many die due to foodborne illness, and the
costs are high, estimated as high as $77 billion just in the
costs associated directly with foodborne illness.
We will never have a zero-risk food supply, Mr. Chairman,
but as the statements have indicated, most foodborne illnesses
are in fact preventable. By preventing foodborne illness, we
can improve public health, reduce medical costs and avoid
costly disruptions of the food system, and with food imports
having risen many-fold over the last 2 decades, we need a
strategy that also addresses the complexities and challenges of
food safety in today's global food system.
Fortunately, Mr. Chairman, FSMA provides us with that
strategy. It is a risk-based prevention strategy that builds on
what the food industry and food safety experts have learned
works to prevent harmful contamination and reduce foodborne
illness. FSMA recognizes the primary responsibility and
capability of those who produce food to make it safe. It calls
on FDA to issue regulations aimed at ensuring practical steps
are taken throughout the farm-to-table system, as you have
indicated, addressing produce safety, processing facilities,
transport, and so forth.
FSMA also provides FDA new inspection mandates and
enforcement tools that we can use to help ensure high rates of
compliance with FSMA's new standards, which is how we will
achieve the food safety and economic benefits that motivated
FSMA's enactment, getting high rates of compliance with the
rules once they are issued.
One of FSMA's most important themes and one that we at FDA
take very much to heart is partnership. FSMA directs us to work
with CDC to improve foodborne illness surveillance, with the
Departments of Agriculture and Homeland Security to help get
our standards right, and, very importantly, with our State,
local, territorial, tribal and foreign government partners to
support and oversee implementation of FSMA standards. In fact,
the centerpiece of FSMA is the mandate to work with the States
and our other partners to build a national integrated food
safety system that will enable us to achieve our food safety
goals more effectively and efficiently. We eagerly embrace
these governmental partnerships in doing our work.
We also believe strongly in partnership with the food
industry and our consumer stakeholders. Our partnership
approach has been demonstrated so far by the extensive outreach
we have done to all segments of the food safety community
domestically and internationally, both before and after issuing
the proposed rules that FSMA mandates. We have benefited
enormously from innumerable public meetings, dialog sessions
and webinars with individual groups and dozens of farm and
plant tours, where my colleagues and I have learned firsthand
how food safety can be achieved on a practical basis across the
great diversity of our food system. We are committed to
sustaining this partnership and dialog approach throughout the
implementation of FSMA.
As you know, Mr. Chairman, and as you have already
acknowledged, we have issued seven major rulemaking proposals
mandated by FSMA, and when they are final, they will provide
the framework for systematically building in prevention
measures across the food system, again, produce safety,
preventive controls, the things that you have pointed out.
I would be happy to answer questions about any of these
rules, of course, but I want to highlight just very briefly
some points about the proposals on produce safety and
preventive controls which we published in January of 2013.
As you know, the proposed rule on produce safety would
require farms covered by the produce rule, and it is a targeted
set of farms, to follow certain standards aimed at preventing
microbiological contamination of fresh produce. The proposal on
preventive controls would require facilities to have a written
plan in place to do modern preventive controls, have plans in
place, verify that those controls are working. These proposals
are grounded in practices that many in the food industry are
already following, but as we seek to create a level playing
field of standards through regulation, we fully anticipated
that a number of challenging issues would arise, and that is
why we have emphasized outreach and dialog and that is why we
have received over 15,000 comments on the produce safety
proposal and over 7,000 on preventive controls. As I say, we
have learned a lot through this process. That is why in
December we announced that we intend to publish and seek
further comment on revised rule language regarding certain key
provisions in the produce and preventive control rules on which
our thinking has evolved. Through this process, we are
confident that we can issue final rules that improve public
health protections while minimizing undue burden on farmers and
food processors.
We also recognize that FSMA will only be as effective as
its on-the-ground implementation of the final rules after they
are issued. Our implementation strategy includes partnering
with other governments to ensure appropriate and efficient
oversight and compliance but also a concerted effort prior to
enforcement to facilitate compliance through education,
technical assistance and regulatory guidance.
Now, before closing, Mr. Chairman, I must note the
importance of finding the resources that FDA will need to
implement FSMA in a way that achieves its important food safety
and economic goals and meets the expectations of our many
stakeholders. We have adequate resources now to issue the
required regulations and conduct the mandated number of
domestic inspections, and we will continue efforts to make the
best use of the resources we have, but simply put, we cannot
achieve FDA's vision of a modern food safety system and a safer
food supply without a significant increase in resources. Last
May, Secretary Sebelius submitted to Congress a report
outlining the resources needed to adequately implement FSMA
including resources needed to retrain FDA and State inspectors,
provide training and technical assistance to small- and medium-
sized farmers and processors, build the Federal-State
partnership and, very importantly, implement the new import
safety system mandated by Congress.
The import need is particularly acute, Mr. Chairman. We
import 50 percent of our fresh fruit and 20 percent of our
vegetables, and imported food shipments have increased from
about 400,000 per year in the early 1990s to nearly 12 million
today, but clearly, our resources have not kept up with this
incredible expansion of food imports. The need to improve
import oversight was demonstrated once again in 2013 by
significant outbreaks of foodborne illness involving the
hepatitis A virus linked to pomegranate seeds from Turkey and
the cyclospora parasite linked to produce from Mexico. Congress
was right in mandating a new import safety system, which is
needed to protect consumers and provide a level playing field
for U.S. producers and processors, but we cannot do what FSMA
mandates without the resources it takes to build the new import
system.
We are grateful, of course, for the resources we have been
given through the 2014 appropriation process, which will be
helpful in the near term, but I would also note that the
President's 2014 budget request included a proposal for
authority to collect two fees that would also go a long way
toward helping us meet our food safety obligations under FSMA
while also, we think, providing benefits for the affected
industry and our State partners. One would address a
registration fee for facilities that are registered with FDA.
The second would be an import user fee, a minimal amount per
entry that would provide resources to fulfill the food safety
purpose of FSMA and also provide greater efficiency and
predictability for importers. We look forward, of course, to
working with you on those.
I want to close, Mr. Chairman, and I appreciate the
indulgence in going over the time, by just saying how gratified
my colleagues at FDA and I have been by the strong expressions
of support we continue to receive from our industry and
consumer stakeholders and from the members of this committee
for moving forward in implementing FSMA. It is important to get
it right, and it is important to get it done, and with an
undertaking of this complexity, we know there will always be
challenging issues, but we are confident that this
collaborative approach that we have taken, pursuing this
approach, we can resolve issues in a way that is good for food
safety and workable across our amazingly productive and diverse
food system. I look forward to your questions, Mr. Chairman.
[The prepared statement of Mr. Taylor follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pitts. Thank you. I will begin the questioning and
recognize myself for 5 minutes for that purpose.
Mr. Taylor, as I said in my opening statement, I have been
waiting for FDA's sanitary transportation rule for some time
since we passed the Sanitary Food Transportation Act. I have
continued to hear some real horror stories about drivers
turning off their refrigerator units to cut cost, and I called
on the agency to expedite its efforts to address these serious
problems. Can you briefly comment on the agency's recent
proposal and what it will do to ensure food is safely
transported from its producer or manufacturer to our local
retailers?
Mr. Taylor. Certainly, Mr. Chairman. We do consider the
safe transport element of FSMA to be an important part of the
farm-to-table prevention strategy. Our science tells us that
this is not the highest risk part of the food system by any
means. We have fairly limited experience in recent years with
outbreaks associated with transport. There have been
historically major outbreaks. The Schwan's ice cream outbreak
in the 1990s made 220,000 people sick by virtue of inadequate
sanitizing of trucks. But the rule that we have proposed under
the FSMA mandate will ensure that there is clarity of
responsibility among those who are shipping product, that is,
who have produced a product and are seeking to have it shipped
to a customer, those who are actually transporting the product
and those who are receiving it, clarity of responsibilities for
ensuring that the right practices are taken across that
transport part of the food system including where it is
appropriate and necessary to protect the safety of food that
refrigeration is maintained.
And so we have focused in on the core elements that we
think are important in transport. We think we have got a
practical system that will provide us clarity of
responsibility. Again, many in the industry are already doing
these things but we will fill in, I think, importantly this
part of the farm-to-table system.
Mr. Pitts. Thank you. There are a number of unique issues
related to the inspection of seafood processing facilities and
imports from abroad. Can you please comment on the various
programs FDA has in place to oversee our global seafood supply
as well as recent improvements made to these systems.
Mr. Taylor. Certainly, Mr. Chairman. Back in 1996,
actually, FDA issued so-called HACCP regulations, essentially
preventive control regulations for seafood processing
facilities, both in the United States and overseas, for
facilities shipping product to the United States, and this is
the modern approach to preventive controls that FSMA has
mandated for the entire food supply and that we are working to
implement, and so we have a long history of implementing modern
preventive controls for seafood. We do import 80 percent of our
seafood, and so the oversight of imports is a crucial part of
the system. The system includes responsibility for the importer
to verify, have some verification from the foreign supplier
that they are implementing modern preventive controls, but we
also prioritize in our foreign inspection program seafood
facilities because we do want to verify that these modern
preventive controls are being implemented and we target
facilities based upon information we know about where potential
hazards might be.
We also have, under the existing law, the authority to stop
product when it comes into the country. This is a reactive
system, and it is not the prevention system that we will
ultimately have when FSMA is implemented, but we have strong
authority. We have used it frequently with respect to seafood
to detain product from facilities or even from countries where
we have repeated violations of issues like animal drug resides
or other matters of concern from a food safety standpoint.
So we have a solid program. We will continue to work to
improve it but it is based upon the modern principles that now
FSMA is mandating comprehensively.
Mr. Pitts. Thank you. The committee appreciates the
agency's efforts in this regard and is committed to ensuring
that unnecessary and duplicative programs do not hamper such
efforts. Provisions added to the Farm Bill at the last minute
expanding the Department of Agriculture's catfish program would
do just that. I agree with GAO and others that while doing
nothing to improve safety, this program is a waste of taxpayer
dollars and would increase compliance costs across the seafood
industry.
Understanding the complexity of the issues involved and the
diversity of those impacted, I appreciate the agency's
extension of comments, particularly with respect to the produce
and preventive control rules. Can you comment on whether the
court-ordered deadline to finalize these major rules has
hindered your agency's ability to continue what I consider an
essential dialog with the regulated community?
Mr. Taylor. Mr. Chairman, we don't feel that the deadlines
have hindered that dialog. The deadlines are a challenge, but
we are organized and focusing our efforts to meet those
deadlines. We believe we can do it. We think our ability to
reopen the comment period for comment on some of the key issues
of concern will advance the process, but we will have to be
very efficient and work very hard to meet those deadlines, but
we are committed to doing it.
Mr. Pitts. The Chair thanks the gentleman and now
recognizes the ranking member, Mr. Pallone, 5 minutes for
questions.
Mr. Pallone. Thank you, Mr. Chairman, and I want to thank
you, Mr. Taylor, for coming here today. I know that Congress
gave FDA a big job to do when we passed FSMA, so I wanted to
ask you to give us a sense of the scope and diversity of the
new responsibilities that FDA is directed to undertake in about
a minute or so.
Mr. Taylor. Just from a practical matter, it is really
about creating comprehensively a new system of prevention. It
is a new food safety system beginning with what happens on
farms where we have never regulated for produce safety before
going all the way through processing and transport and then
recognizing that we have to manage global supply chains, so it
is an entirely new import oversight system. So it is a massive
undertaking. If you just read the law and count up the
deiliverables, as I think you indicated, it is a huge task and
it is requiring us to mobilize everything we have got now and
to figure out, you know, and be very clear about the resources
that we will need to carry it forward to successful
implementation.
Mr. Pallone. Thanks. I touched in my opening statement, I
said that CDC estimates that 48 million Americans get sick,
128,000 are hospitalized and 3,000 die each year from foodborne
illnesses, and these numbers show that this is a serious
problem that can be devastating for families.
Let me ask you two questions. What are the impacts on
consumers who contract a foodborne illness and how will FSMA
benefit consumers and reduce the burden of foodborne illness?
Mr. Taylor. Mr. Chairman, some people think that foodborne
illness is just an upset stomach, and many of those 48 million
cases are transitory illnesses, but they do add up to a big
public health burden in and of themselves, but many foodborne
illnesses are devastating, lifetime damaging experiences.
People lose organ function. People's lives are changed forever
and incurring not only great suffering on their part but
medical costs, and then 3,000 people die. So it is more than a
transitory stomachache.
And again, the whole idea here is to build in the practical
preventive measures that can stop E. coli and salmonella and
other pathogens that can make people sick from getting into the
food system and doing that in the most practical but systematic
way possible, and by doing that, again, we are not going to
eliminate foodborne illness but we can substantially reduce
these illnesses and benefit consumers. These illnesses are
largely preventable, and I think what people expect is that we
do everything we reasonably can to prevent them, and I think
that FSMA is the mandate and the system to do that.
Mr. Pallone. Well, I am going to get into the resources
issue because you mentioned that, and that is obviously very
relevant.
FSMA gives FDA many new tools to use to improve the safety
of the food supply. However, I am concerned that you will have
a hard time making full use of them without added resources.
The agency's report to Congress last April on domestic capacity
building to implement FSMA mentions there is a gap in funding
needed to fully implement the law and it briefly discussed how
the authority to generate new user fee revenues would be used
for food safety, and as you know, the food safety bill that the
House passed in 2009 did include facility registration and
importer fees to increase resources.
Would you just comment on what the food-related fees
proposed in the President's fiscal year 2014 budget would be
used for if Congress gave FDA the authority to collect them,
and how would the absence of user fee revenue affect the
agency's ability to continue to implement FSMA?
Mr. Taylor. So there are two fees, as I mentioned. One is a
facility registration fee. Those resources would be focused on
improving inspection and being sure that our inspection force
is trained and prepared to work under the new modern preventive
system, so training for inspectors would be a big part of that.
Those resources could also be used to support the Federal-State
partnership. We think we can be more effective working closely
with State partners who already conduct some inspections for
us. They need their own training and capacity building.
The import fee would really be the key to building the new
import system. We are mandated to establish this foreign
supplier verification program requirement but that puts us in
the position, which we want to be in, of auditing complex
supply chain management systems. We need a whole different
training and orientation of a frontline workforce. We need
staff to do that work in addition to actually checking product
coming in at the port of entry, and then very importantly,
Congress, I think, wisely mandates us to be much more present
overseas, to work with foreign governments, to do more foreign
inspections, to see that preventive measures are being taken
offshore. So it is really building that new import system that
the import fee would be crucial for.
Mr. Pallone. All right. Thanks so much. I still have a few
minutes.
The chairman mentioned the catfish, and I would like to
know, has FDA found catfish to be a high-risk food and can you
describe for us the system FDA has in place for fish and
seafood safety and whether FDA has found that catfish pose
unique or special risk warranting special oversight?
Mr. Taylor. Certainly, the reason we issued the HACCP
rules, the preventive control rules for seafood, is because
seafood, if not handled properly, can present concerns, but
within the seafood universe, we actually think catfish is on
the lower end of the spectrum of potential risk. It is not sold
in a form that is ready to eat. Smoked product, for example, is
more risky. It is not consumed raw, generally, and we don't
have a history of outbreaks associated with catfish.
Mr. Pallone. All right. Thanks again.
Mr. Pitts. The Chair thanks the gentleman and now
recognizes the gentleman from Illinois, Mr. Shimkus, 5 minutes
for questions.
Mr. Shimkus. Thank you, Mr. Chairman, and welcome, Mr.
Taylor.
So in the full committee and our various subcommittees, it
is amazing how some things reoccur, so my discussion is going
to be--I am going to use the term ``recycling'', but as we have
found in other sectors, we force ink producers to throw away
ink instead of bringing them back through the process because
of rules and regulations. As we heard yesterday, we force
electronic manufacturers to throw away their boards instead of
recycling them because of rules and regulations.
So this is the first question. In the process of
commodities that are already safe for human consumption that
goes through the process in the front end, and let us just take
barley that is going to go into production of adult beverage--
beer. Then it goes through the process but then there is always
obviously the remaining ingredients after the process has
occurred. Many times that then is used in animal feed issues.
Now, a concern is developing that if in this process then FDA
then forces that end-use muck that has been used in animal feed
to then go through another inspection process to see if it is
safe for the feed processing and animal feed, then you will do
the same thing that we did with ink and the same thing we do
with computer boards. We will then add an additional burden in
disposal and then we will take away a commodity product for
food processes. That is a concern. Can you speak to that?
Mr. Taylor. Sure, Mr. Shimkus. We are aware of this issue,
and of course, we have proposed a preventive controls rule for
human food facilities and a preventive control rule for animal
feed and animal food facilities based on the same principles
that the law lays out, but there are differences in the way in
which human and animal feed need to be handled for safety
purposes, so we have two separate rules. But they have to fit
together and they have to work in a way that does not disrupt
this practice. We are very aware of this relationship between
human food and animal food production, and we don't see any
reason from a food safety standpoint to disrupt that at all,
and based on the comments that we are getting and will get on
this, I think we can harmonize these rules and avoid the
concern that you are raising. I am confident about that.
Mr. Shimkus. OK. You understand the concerns, and our basic
premise is, if the entry point is safe for humans,
understanding you have got to figure out the endpoint and the
processes, but it should be safe for animal feed for the most
part.
Mr. Taylor. Yes. And the system is all about being risk-
based and it is about not duplicating effort, and so there are
any number of ways in which we are being very careful to be
sure that we are getting the control we need but not having
duplicative controls.
Mr. Shimkus. But you don't know of any record in that
process of animal feed through that processes has caused any
human health indications? There has been no report to anybody
that there has been any incident?
Mr. Taylor. I am not aware of it sitting here. If others
are, we will put that in the record.
Mr. Shimkus. And I don't think there is either, and that is
the point of the debate.
Mr. Taylor. Thank you.
Mr. Shimkus. I appreciate it.
Let me also then go to--there is a great deal of
variability in food products and processes, as you know.
Therefore, a successful testing program is tailored to a
specific circumstance related to each product in manufacturing
operation. How will the regulation be written to assure that
testing is risk-based and not prescriptive, very similar to the
other previous question but this is really just in the initial
phase.
Mr. Taylor. That is very important. I think we all know
from long experience that certain kinds of testing programs and
certain kinds of facilities can be important to verifying the
controls are working. Peanut butter processing facilities, for
example, where salmonella in the environment can contaminate
peanut butter and cause a significant problem. Most companies
undertake so-called environmental monitoring testing of the
environment to verify that the sanitation and other measures
are preventing the presence of that pathogen.
But it is also well understood that those testing programs
have to be based upon the particular risk considerations, the
processing systems and the products in that particular
facility. There is no one-size-fits-all solution, and I think
if we are agreeing on anything across the board, one-size-fits-
all doesn't work on any dimension really here.
Mr. Shimkus. I think that is what we find out in our
committee, and going back to the hearing yesterday on another
subject, risk-based is where we need to be, and really, the
private sector, if you evaluate their testing processes and you
find that it adequately does the test, the concern is,
government will be prescriptive and they will say test it this
way where we know that the industry has already got a pretty
good process of ensuring safety and efficacy.
Mr. Taylor. If I may, just really briefly, I mean we know
there are firms that have invented the standard of care, if you
will, or have programs that are in place and are doing the
right thing and in fact go beyond what we would end up
mandating. We have to have rules that are flexible enough to
not disrupt those ongoing processes while also setting a
standard of care that is clear and implantable by those who
aren't there yet and who FSMA is intended to bring up to an
appropriate standard. So that is the balance we need to strike
in the final rules.
Mr. Shimkus. Thank you very much.
Thank you, Mr. Chairman.
Mr. Pitts. The Chair thanks the gentleman and now
recognizes Mr. Matheson, 5 minutes for questions.
Mr. Matheson. Well, thank you, Mr. Chairman. I appreciate
the committee holding this hearing. I think this is a good
thing for Congress after it passes a law to take a look at how
it is being implemented. I think that is something we ought to
do a lot of in Congress across all committees, so I do
appreciate this hearing.
Mr. Taylor, I have heard some concerns raised, and this may
have been covered a little bit before but I am going to ask you
again anyway. I have heard concerns raised about the language
in the proposed rule on the preventive controls. Some have
raised a concern that the use of the phrase ``reasonably likely
to occur'' in the rule is different than the Congressional
intent, which would be ``reasonably foreseeable'' that is in
the law, that is the term. Can you talk about these concerns,
the validity of these concerns, what these different--you know,
to me, these are two different sets of language, and I don't
know want to get into semantics, but sometimes it matters, so
can you talk about that, about what that means?
Mr. Taylor. Sure, and we don't need to go into a lot of
detail to sort of get what is the central important point. It
is one that we were just discussing. Concern really rises from
folks whose systems are advanced, they are established, they
are clearly achieving the sort of prevention that FSMA is
about, and we want to be sure that we don't use language and
rules that would create a concern about forcing change in those
practices that don't make a practical difference for food
safety, and we have had a lot of dialog with industry
stakeholders, particularly on this point, and we think there is
a way to solve this and manage this so that we achieve the
purpose that I just recited. We need flexibility for them but a
standard that we can implement and enforce where needed for
those who aren't there yet.
Mr. Matheson. So to the extent you have heard concerns
raised about this, you are trying to work with stakeholders
right now to figure out a way to----
Mr. Taylor. Absolutely. We have very active dialog. This is
a solvable issue.
Mr. Matheson. That is great.
The next question I would ask is, the law asks for an
increase in the number of domestic food facility inspections.
Do you have any indication of how many inspectors that is going
to take and what the costs are going to be for this?
Mr. Taylor. Well, I think one of the things that is
fortunate is that with the increases that have happened over
the last few years, we feel that we have the number of people
we need to meet that domestic inspection frequency mandate, so
that is a part of FSMA where we think we can hit the number.
What we don't have is the resources right now to retrain and
reequip those inspectors to work in this sort of modern
preventive controls environment where we want to be focusing on
the public health outcome and not just a checklist of
regulatory requirements. So we need that, and then----
Mr. Matheson. Do you have those resources, by the way?
Mr. Taylor. We don't have that, and that is the kind of
additional funding that we need in order to implement FSMA
successfully to really get the full modernization benefit that
FSMA is about.
Mr. Matheson. Do you have a sense about what that gap might
be?
Mr. Taylor. I will stick with the request in the
President's budget and it included about $225 million in fees,
which would go a long way towards closing the FSMA funding gap.
The total FSMA funding gap that Secretary Sebelius recited to
Congress in the spring of last year was $400 to $450 million
above our 2012 base. We took a step back in 2013. We took a
step forward in 2014. We still have a sizable gap.
Mr. Matheson. Do you plan to use third parties to conduct
some of your inspections?
Mr. Taylor. No, sir. We will partner with State governments
and other governmental partners on inspection. We do see the
value of working to strengthen the private audit system that
the industry has developed over the last number of years, and
the law itself, as you know, mandates that we establish an
accredited third-party certification program for certain import
oversight purposes that are fairly narrow and targeted, but we
would not ever think of private audits as a substitute for our
inspection.
Mr. Matheson. For the ones that are not domestic, for the
ones overseas, how is that third-party system implemented so
far? How is that going?
Mr. Taylor. The way in which Congress has prescribed that
accredited third-party auditors be involved in certifying the
safety of imports is in two situations. One is, as part of the
so-called voluntary qualified importer program, which is the
expedited entry system for people who are going the extra mile,
that would include an accredited third-party audit of the
foreign facility. We also have the authority to mandate an
accredited third-party audit for particular high-risk
situations, but those are the specific uses for which the
accredited third-party audit is in the law.
Mr. Matheson. All right. Well, thank you for your answers,
and Mr. Chairman, I will yield back.
Mr. Pitts. The Chair thanks the gentleman and now
recognizes the chair emeritus of the full committee, Mr.
Barton, 5 minutes for questions.
Mr. Barton. Mr. Chairman, thank you. I am going to yield my
time to Mr. Walden of Oregon.
Mr. Walden. I thank the chairman emeritus, and I thank the
chairman for holding this hearing, and Mr. Taylor, it is good
to see you again. I have appreciated the meetings that we have
had with you and your team and your openness to taking a look
at how some of the ag practices actually occur on the ground
and may be in disconnect with the original rules, and I
appreciate your coming out to the Northwest and bringing your
folks to meet with a lot of our growers out there, especially
on the east side of my district with the onion growers who
actually are having their annual conference about now and to
witness firsthand how irrigation works and the kill step in
growing onions and the safety of how they do it, so I was
really pleased you were open, you listened, you pulled back the
regs that would have been in conflict and moved forward, so I
commend you for that, and I hope the science that our OSU lab
produced out there on this issue involving onions was helpful.
I sense that it was in your decision-making.
My question relates to, as you go about redrafting the
rules and what interactions you might be having with farmers
and ranchers out in the West, certainly in districts like mine,
and as you write these new rules, obviously that continued
communication is important to the extent it is allowed under
your rulemaking process.
Mr. Taylor. Thank you, Mr. Walden. The trip to your
district was just a great learning experience for all of us,
and we appreciate the hospitality that you and your colleagues
there showed us.
But yes, when we reopened the comment period and proposed
alternative language on certain key provisions, there will be
at that point an opportunity to have not only written comments
but to engage directly with people who will have perspectives
on what we have re-proposed, and we will be re-proposing on the
water standard including the standard itself and the testing
regime that we propose, so there will be interest, no doubt, in
your community. We look forward to whatever dialog would be
useful. And the research that is going on in Oregon at the
University is helpful work, and we are collaborating closely
there, and I think we can address the concerns that we heard
about out there.
Mr. Walden. And as you know, there was some language in the
Farm Bill that dealt with some of these issues around the rules
in terms of the economics and I think in terms of the science
as well. Obviously it is critical that we get a science-based
set of rules that actually work in the real world. I know when
I was out and met with our onion growers, toured around, as you
and your team did at another time. They were just pointing out
how from field to field you could have radically different
readings for no real reason that is even manageable, and
meanwhile I think one of the growers told me they have been
growing onions there for a hundred years and never had an
outbreak of salmonella, and they bagged I don't know how many
millions of bag every year. I thought that was a pretty big
sample size if you were going to do a statistical analysis of
risk, and so I appreciate your pulling back on those rules. It
is just essential whether it is there or our cherry and pear
and apple growers or blueberry growers that we get this right
and not upend them. And of course, they have concerns about
imported foods, do they meet the same ag practices we are
putting on American farmers and we ought to be careful. None of
us wants spoiled food. None of us wants the illnesses. I
actually helped lead some of the investigations into Peanut
Corporation of America but that was a case where they did
things that were against the law to begin with, and they are
paying a very severe penalty, as they should, for their
actions. So we want to make sure we have got this balance right
between safety of our food supply that allows for productive
agriculture to continue in a way that works.
Again, I thank you for listening to us and actually coming
out on the ground, and I hope that as we go forward with those
rules that there will plenty of time for our folks that are
going to have to abide by them to have full input.
Mr. Taylor. Absolutely. We are working toward the same
goal, and we will get there by working together, so we look
forward to that.
Mr. Walden. Thank you. Mr. Chairman, I yield back to the
Chair.
Mr. Pitts. The Chair thanks the gentleman and now
recognizes the ranking member emeritus of the full committee,
Mr. Dingell, 5 minutes for questions.
Mr. Dingell. [Inaudible.] It is important and, as a matter
of fact, urgent, and I am pleased that the subcommittee is
conducting proper oversight of this important law. This is the
way oversight should work. The Food Safety Modernizationn Act
was a strong bipartisan response to the globalization of our
food supply and to the numerous tainted food products coming in
from abroad. It is clear that FDA needed new, innovative
authority to ensure the safety of imported foods. It also
needed money and personnel to do its job. FSMA was a
significant step forward, but we have a lot of work left to do.
The CDC estimates 48 million people get sick from foodborne
illness each year. Furthermore, 128,000 people are hospitalized
and 3,000, at least, die. Although we are not going to get
these numbers down to zero, we must continue to focus on
improving food safety in this country, particularly that which
comes in from abroad. While FSMA represents a significant
increase in authority for the FDA, Congress has only solved
half the problem.
We also need to give FDA the resources it needs to fully
implement FSMA and to create a proper, adequate 21st century
food safety program.
Mr. Taylor, I request that you answer these questions yes
or no. Does FDA have the resources in money and personnel it
needs to properly implement the Food Safety Modernization Act?
Yes or no.
Mr. Taylor. No, sir.
Mr. Dingell. I would appreciate it if you would submit to
us a proper survey of what you need in the way of money to
accomplish this purpose.
The Obama administration's fiscal year 2014 budget request
included $59 million in food facility registration fees and
inspection fees, and $166 million in food import fees to help
fund food safety activity. Does FDA continue to support user
fees to pay for FSMA? Yes or no.
Mr. Taylor. Yes, Mr. Dingell.
Mr. Dingell. Congress gave FDA a big job to do but clearly
not enough money to do it right. I would note that the House-
passed version of FSMA contained user fees that would have
helped solve the problem, but this provision did not make it
into the final version of the legislation. Many stakeholders
continue to have concerns both about the timing and the
substance of FSMA regulations. I would posit that these issues
may not have been a problem if we had done the right thing
early on and given the FDA the resources that they needed.
Today, we find FDA under court-ordered deadline to finish
all FSMA regulations by June 2015. Do you have the money to do
that?
Mr. Taylor. Yes.
Mr. Dingell. You do?
Mr. Taylor. To get the regulations issued, yes, sir.
Mr. Dingell. All right. Passage of FSMA was the product of
collaboration between industry, consumer groups and the agency,
and I think the industry deserves accommodations for the fine
work they did on that matter from start to finish. I hope that
this process will continue as FDA moves forward with the
finalizing of these critical regulations.
Next question. Mr. Taylor, will FDA commit to working with
all stakeholders in considering public comments as the agency
works to meet the June 2015 deadline for issuing final
regulations? Yes or no.
Mr. Taylor. Yes, absolutely.
Mr. Dingell. Now, one critical part of FSMA is increased
inspections of both foreign and domestic food facilities, and
FDA will need to hire more inspectors to properly do the job,
and I happen to think that we desperately need more inspection
of foreign producers and more scrutiny and surveillance of
foreign producers and others who enter the food supply chain.
Is that a correct assumption?
Mr. Taylor. Yes, that oversight is important.
Mr. Dingell. Now, FDA will need to hire more inspectors to
properly do the job. Is that right?
Mr. Taylor. Yes.
Mr. Dingell. And you are going to have to have some more
for overseas?
Mr. Taylor. Yes. We have the resources for domestic but not
for overseas inspection.
Mr. Dingell. Does FDA have the resources to meet the hiring
targets set by FSMA? Yes or no.
Mr. Taylor. Yes, for----
Mr. Dingell. You do?
Mr. Taylor. No, no, no.
Mr. Dingell. You do not have those resources?
Mr. Taylor. Those targets in the law, we do not have the
resources to meet them.
Mr. Dingell. I don't want the record obfuscated on this
matter. Will you submit, please, a detailed response for the
record including the resources you need and how many FTEs, or
full-time equivalent employees FDA needs to hire?
Mr. Taylor. Yes, we will.
Mr. Dingell. And how many do you plan to hire?
Mr. Taylor. Well, our plan will be the function of the
resources we get, and we will lay that out in the response.
Mr. Dingell. Submit for the record, if you please.
Mr. Taylor. Yes, sir.
Mr. Dingell. FSMA also contains some exciting new
authorities that are already in place and are protecting the
American people including mandatory recall of tainted food
products. That is a new authority to the agency. Is it working?
Mr. Taylor. Yes.
Mr. Dingell. Does it need change?
Mr. Taylor. It works. We don't think it needs changed.
Mr. Dingell. Has FDA exercised a mandatory recall authority
under FSMA? Yes or no.
Mr. Taylor. Yes. We have initiated the process twice. The
firms have wisely voluntarily recalled once we invoked the
mandatory authority.
Mr. Dingell. They didn't fight you on the recall?
Mr. Taylor. No, sir. That is the power of this authority.
Mr. Dingell. Are you comfortable that the authority is
sufficiently sweeping and adequate to carry out your
responsibilities there?
Mr. Taylor. Yes, within the food part of FDA.
Mr. Dingell. Food?
Mr. Taylor. Yes.
Mr. Dingell. Now, you do not have the authority with regard
to pharmaceuticals, do you?
Mr. Taylor. That is correct.
Mr. Dingell. And how about other things like devices,
knees, hips?
Mr. Taylor. You are leading me out of my territory, Mr.
Dingell, but there are gaps in FDA's authority on the medical
products side with respect to mandatory recall.
Mr. Dingell. I want to thank you for this. I believe that
mandatory recall is a useful tool in any emergency and should
be expanded to the other areas that we have just been talking
about in the agency's jurisdiction.
Now, FDA has a large task ahead of it, and as the agency
works toward final implementation of FSMA, I urge the agency to
move quickly during the rulemaking process while continuing to
engage in a collaborative process with the stakeholders because
working with the stakeholders will be the way that you will get
their support, their wisdom, and the ability to do your job
better.
Mr. Taylor. Thank you, sir.
Mr. Dingell. Mr. Chairman, you have been most courteous in
giving me extra time, for which I thank you.
Mr. Pitts. The Chair thanks the gentleman and now
recognizes the vice chair of the subcommittee, Dr. Burgess, 5
minutes for questions.
Mr. Burgess. Thank you, Mr. Chairman. As I was listening to
that exchange with Chairman Dingell, it took me back to the
heady days when he took the gavel from Mr. Barton, and in fact,
if you look back at that time, the budget for the Food and Drug
Administration was about $1 billion and today it is more than
that. Is that a fair statement?
Mr. Taylor. Yes.
Mr. Burgess. It is about two and a half times that amount?
Mr. Taylor. In budget authority, yes.
Mr. Burgess. So----
Mr. Taylor. That is for the agency as a whole, not for the
food side of things.
Mr. Burgess. Correct. But even with the sequester, the Food
and Drug Administration received from Congress an increase of
nearly $100 million over the amount provided in fiscal year
2013, and in fact, you got several million dollars over the
agency's budget request. Is that not a true statement?
Mr. Taylor. We got what we asked for on food safety to
implement FSMA, yes.
Mr. Burgess. OK. So nearly a billion dollars, $900 million,
was targeted to the food and safety network. Is that correct?
Mr. Taylor. Yes, sir.
Mr. Burgess. So Mr. Dingell was talking to you about the--
he wanted some detail on the resources that you think you might
need. I guess that means resources in addition to that $900
million was what he was asking for, but can you provide us the
accounting of how the $900 million has been spent so far that
was targeted to the Center for Food Safety and Applied
Nutrition?
Mr. Taylor. We can do that. Just to be clear, that $900
million you are referring to is total funding for all food-
related activities at FDA. We have certainly deployed a huge
part of that to FSMA implementation but those resources also
cover what we do in food additive regulation, in nutrition,
dietary supplements, you know, a range of other programs that
we are responsible for. That is not all for implementing the
Food Safety Modernization Act, but we can certainly provide you
that information.
Mr. Burgess. Could you provide us that with a level of
detail so we would be able to--the key here is discernment.
Chairman Dingell asked you for what you might need in the
future but I would like to know what is being given and what is
being spent and how it is being spent currently.
Mr. Taylor. Yes, indeed.
Mr. Burgess. Let me ask you, because he brought up the
issue of foreign suppliers, the scrutiny of foreign producers,
I think, was the terminology he used. How are you organized or
structured to make certain that there is that fairness that he
was talking about, that we are not discriminating against local
producers that are advancing foreign producers at the expense
of local producers?
Mr. Taylor. Sure. So the answer to that is being able to
implement the full FSMA import toolkit that we have been given
to create this new import oversight system. The foundation for
it is the foreign supplier verification program requirement,
which makes the importer accountable for having a plan through
which they can document that they know where their product is
coming from, their imported product, and they can verify in an
appropriate way based upon risk that the proper controls have
been implemented at the foreign supplier point. That private
sector responsibility for supply chain management is the
foundation for this new import system and it is much more
preventive and, again, reliant on industry. It will work,
though, to the extent that first we can have people who are
trained and we have adequate numbers of people to check that
those systems really mean something, that they are not just
words on a page, so verifying that those audit systems are
working----
Mr. Burgess. And I think that is the key because we
certainly heard through hearing after hearing after hearing in
2007 and 2008 and on into 2009 about where the problems
existed, and there were imports that were coming in that had no
business coming in. Are we better prepared today to deal with
those problems?
Mr. Taylor. Well, we are building a system that will enable
us to be prepared.
Mr. Burgess. But we are not there yet.
Mr. Taylor. No, we are not there yet. I mean, again, I
think there is--you know, FSMA has stimulated a heightened
recognition and reflects a heightened recognition as well
across the food system that we need to be improving how we
manage supply chains globally as well as domestically, but FSMA
won't fulfill its purpose until we not only have the
regulations promulgated but until we can actually verify that
the system is working. And again, Congress----
Mr. Burgess. My time is running out. What are the barriers
to promulgating those regulations right now?
Mr. Taylor. It is just a lot of work, a lot of issues, but
we are deploying the people to do that. You know, that is our
priority, is to get those rules done.
Mr. Burgess. But when this legislation was passed by
Congress in 2010, the promise was that we were going to prevent
these problems that had been happening with such alarming
regularity that we were going to protect the American people,
that the FDA had not been able to keep up with the effects of
globalization but that was going to change. When can we tell
people to expect that change we can believe in to have
happened?
Mr. Taylor. FSMA will fulfill its purpose when we are able
to implement it, and it is not just the rules. It is the
ability to oversee the rules. So it is a process that over the
next several years will have the benefit that you seek but it
is not an overnight process to build a modern food safety
system for this century.
Mr. Burgess. Several years, meaning it could be a decade?
Mr. Taylor. I think it won't be that long before you will
have rules in place and the ability for us to verify that those
rules are being implemented if we get the resources.
Mr. Burgess. I hope not, because a decade actually would be
2020. That would be the 10 years from the passage of the Food
Safety Modernization Act.
Mr. Taylor. I understand. Yes, sir.
Mr. Burgess. Thank you, Mr. Chairman. I will yield back.
Mr. Pitts. The Chair thanks the gentleman and now
recognizes the gentlelady from California, Ms. Capps, 5 minutes
for questions.
Mrs. Capps. Thank you, Mr. Chairman.
Commissioner Taylor, I thank you for your testimony, and I
am glad to be here today ensuring that the Food Safety
Modernization Act is and continues to be as effective as
possible. I understand that the FDA faces an immense scope of
responsibility in implementing the Food Safety Modernization
Act. You mentioned that FSMA will only be as effective as its
on-the-ground implementation, and I agree.
Agriculture is one of the primary economic drivers in my
district, and so these issues certainly hit close to home. Food
safety for fresh produce such as leafy greens is obviously
incredibly important. As you may know, following an earlier
food safety crisis in 2007, California leafy green growers,
many of them that are in my Congressional district, took it
upon themselves to raise the industry safety bar by creating
the California Leafy Green Products Handler Market Agreement--a
mouthful, LGMA for short.
Since its founding, LGMA has become a strong collaboration
between government and farming communities. They incorporate
science-based food safety practices and mandatory government
inspections in an effort to ensure safe leafy green products.
The LGMA has already been, for all intents and purposes,
verifying the leafy green industry's compliance with food
safety practices that meet or exceed the specific rules being
proposed under FSMA. Obviously we all want to make the
processes as efficient and effective as possible, ensuring high
standards without creating unnecessary redundancies. I just met
with the California Farm Bureau folks, a couple from my
district, just now. This is very much on their minds.
So my question to you: Can you tell me what the agency is
doing to collaborate with groups like LGMA in this process? How
will FDA work with industry to verify compliance with the new
FSMA laws?
Mr. Taylor. Thanks very much for the question. The Leafy
Green Marketing Agreement is a real demonstration of leadership
on that part of that industry, which has come about in response
to some of the outbreaks that were very costly and disruptive
for that industry, and the standards that they have put in
place and that they monitor themselves are very positive and
are standards that, as you say, will likely meet or exceed what
the Federal standards will be, and we certainly, as we think
about how we verify compliance with this broad range of
standards, absolutely want to cooperate with and place reliance
where appropriate on these private efforts to monitor and
verify and demonstrate that their product is being produced in
accordance with these standards.
So we meet with, we collaborate with the folks involved in
the Leafy Green Marketing Agreement. It is a very positive part
of progress on food safety, so we embrace it.
Mrs. Capps. So it is not like one person has the rules and
the other person is trying to comply, but you are all in it
together?
Mr. Taylor. Enormous dialog and recognizing that we want to
capitalize on what leaders in the industry have learned and
then, again, not disrupt those practices that are working just
out of some----
Mrs. Capps. Let me just push this a little further. Not
that I don't agree with what you are saying, but as you know,
unfortunately, contamination in our food supply repeatedly has
threatened the health of Americans over the years, and you
mentioned how costly it is to the industry as well. These
events have really initiated such fear in consumers,
considering the safety of our food supply--the very food that
is the best for us. So we need more of a win-win, and I think
that is behind this effort here, a bipartisan effort, to enact
the Food Safety Modernization Act.
Now, several years postenactment, how have we become more
prepared? Do you think we are in a position where we could not
just prevent but anticipate the next big outbreak? How will the
FDA be more effective in dealing with the next big food
contamination emergency?
Mr. Taylor. I think there are a couple of things. I
mentioned already that I think FSMA is part of a process where
we have been making progress in the private sector and through
collaboration between government and private sector to put in
place practices even as we anticipate FSMA being implemented,
and that is one way in which I think we are hopefully making
progress. We have also done a lot of work at FDA and with the
CDC to be better at detecting outbreaks earlier. We have
created a focused, specialized team at FDA to do early
detection of potential outbreaks, to respond more quickly, and
then importantly, to learn from outbreaks. And so we have
investigated, for example, the cantaloupe outbreak that killed
33 people associated with Listeria in cantaloupe. We did an
investigation of what the potential cause was, and then we have
been out collecting additional data to inform the cantaloupe
industry about measures that can and should be taken.
So there is a lot of work going on which will continue,
even as we get the regulations in place and are able to verify
that the practices that we are learning work are in fact being
implemented comprehensively, not just by the leaders but
comprehensively across the system.
Mrs. Capps. OK. Great. I will yield back.
Mrs. Blackburn [presiding]. The gentlelady yields back. Dr.
Murphy for 5 minutes.
Mr. Murphy. Thank you, and welcome here. We appreciate your
testimony. It is very enlightening.
I am wondering, the CDC a couple years ago said that there
was a reduced or different risk in foreign imported products
versus United States. Does that difference still exist?
Mr. Taylor. You know, the data that could be quantitative
about this are limited but CDC did report increases in
significant numbers of outbreaks associated with imports. And
so we know that food can be jeopardized, whether domestic or
imported, but imports are very much a public health concern.
Mr. Murphy. I am just curious then. Is there a difference
in seafood, meats, fruits, vegetables? Any categories in terms
of which are at higher risk, or does it vary?
Mr. Taylor. It varies across category, and again, CDC has
put out the best data on that, and again, I don't have time to
go into detail but we could provide that for the record.
Mr. Murphy. I appreciate that. Also, there have been
concerns that have been raised in some sectors in the public
about genetically modified organisms, genetically modified
foods. While some may have concerns of risk, are there
potentials that you are going to explore in the future with
regard to some modifications that would lead to reduced risk
for foodborne illnesses among some of these?
Mr. Taylor. Regrettably, I am recused from working on
matters related to genetically modified organisms, and so if
you don't mind, we will----
Mr. Murphy. That is fine. You had mentioned that you are
taking steps to inform some growers, some products of actions
that they can take to improve safety. I appreciate that. Are
you also providing technical assistance or support to them in
particular to help them comply with rules?
Mr. Taylor. That is a very important part of our strategy
and our plan. Even well before the rules are final, we have
created in collaboration with USDA and with the State
departments of Agriculture the Produce Safety Alliance at
Cornell University, which is all about developing training and
technical assistance materials for small growers. So this is
central to our strategy. Educate before you regulate is a
mantra that many of us are using.
Mr. Murphy. So you would have been working directly with
some of the growers and food manufacturers, listening and
communicating with them on those?
Mr. Taylor. Yes, through their organizations and directly
working with them.
Mr. Murphy. Thank you. When a product is linked to some
sort of outbreak and consumer confidence plummets, in many
cases the company that had nothing to do with the issue will
see sales of similar products decline, even though they are not
part of that. How does the Food Safety Modernization Act
address this to prevent some single outbreak from crippling a
whole sector of the agricultural industry?
Mr. Taylor. That is a very important point because that is
why many people in the industry are supporting this so strongly
because they can be affected by what others do. The fundamental
thing, of course, is to prevent these outbreaks as much as we
possibly can so you don't have the loss of consumer confidence
and market disruption, and FSMA will contribute to that
greatly.
The other piece, I think, is this effort to detect
outbreaks more quickly. The sooner we can detect an outbreak
and contain it, the less disruption there is, and so both of
these things, prevention and response, work together.
Mr. Murphy. Now, also in addition to what is being done
with growers, food processors, manufacturers, distribution,
grocery stores, et cetera, what is being done in terms of
public information campaigns to help all of us and our
households know what should be done at home in terms of food
storage, food preparation, what should be looked for in
products that could tip off ways that the food may be
containing some sort of illness?
Mr. Taylor. That is a really important question, and both
FDA and USDA have consumer education programs. They are fairly
modest in scale. We work with the Partnership for Food Safety
Education, which is a collaborative undertaking between
industry, consumers and government. We need to do more on
consumer education as part of the public health prevention
system in our mind, and one thing that has happened over the
last year or two has been an Ad Council campaign, for example,
that has tried to reach consumers through the advertising
media. But there is more to be done to really understand how
consumer education can be done in a way that does change
behavior and reduce risk. We can't depend on consumers to solve
the public health problem but they are part of the ability to
minimize risk, and we want to work in that as well.
Mr. Murphy. I hope so. I mean, I can't recall ever seeing
an ad of any kind that talks about some of these issues with
food safety.
Mr. Taylor. It is very limited.
Mr. Murphy. And yet we are the last part there. Other than
knowing, you know, if there is a bulging can, don't open it or
eat it, or look at the date on something or what most people do
is simply smell the milk, and if it smells bad, don't have it,
but other than that--I hope that that is an area because that
is an area of public outreach I think is essential for people
to know that.
Mr. Taylor. Agreed.
Mr. Murphy. All right. Thank you. I yield back.
Mr. Taylor. Thank you.
Mrs. Blackburn. The gentleman yields back. Mr. Green, 5
minutes.
Mr. Green. Thank you, Madam Chairman, and I thank the chair
and the ranking member of the committee for this hearing today.
Commissioner Taylor, I want to thank you for being here and for
your patience with us.
I have a district in Houston, in fact, the Port of Houston,
and so a few years ago I had the opportunity to be on the docks
with not only FDA inspectors but other inspectors for our food
safety, and in Texas, we have not only a number of ports that
bring in but we also have a huge land border that brings in
untold amount of foodstuff from Mexico. Ensuring that the roles
are effective in protecting public health and supporting
industry best practices is critical. I believe that two of the
most contentious rules you are developing are those
establishing prevention, preventive controls and produce safety
standards. It seems to have taken a long time for FDA to
release them, and in fact, it may only have been because of the
court order that you were able to release them when you did,
and since that release you have delayed the close of your
comment periods and announced you may be re-proposing parts of
each of them.
My question is, considering the foundation of these rules
are for establishing a preventive food safety program, can you
tell us why they have taken so long to develop their release? I
would hope that the proposed rules in working with the
stakeholders you realize you have gone back to the drawing
board, if that is part of it. But like my colleague from Texas,
Dr. Burgess, said, it has been 3 years since the law passed.
Can you describe the process you have gone through to develop
them including engagement of those stakeholders and explain
what makes them so contentious and can you explain their
importance to public health?
Mr. Taylor. Sure, sure, and I appreciate your impatience. I
have experienced it myself, and we are all working hard to get
this done as quickly as we can. We do think it is critical to
get it done right. We are really laying the foundation for the
next 50 years of successful food safety oversight in this
country, and I think we do have enormous momentum with the
seven proposals we have published since last January.
I think one reason it takes time is because these proposals
do have to work together, first of all. It is like putting a
puzzle together and there are a lot of complexities among the
provisions, but also we can't lose sight of the fact, and this
gets to the question of why there are--you know, we have had a
very vigorous dialog with people with different points of view.
We are building a new system that affects a lot of economic
activity and a lot of actors in our food system, and so
understandably, people have perspectives, they have information
that they want us to consider, and we feel obligated to and we
want to because it is how we will get a good set of rules that
will work for the long term. So we feel good about the dialog
we have had. We think the process has real momentum. We are
working to meet the court deadlines and balance these two
considerations of speed and ability to be sure everyone is
heard and we have got the best possible rules at the end of the
day.
Mr. Green. My other concern is improving foodborne illness
surveillance. It is a critical part of the Food Safety
Modernization Act. I have been told that foodborne illnesses
are woefully underreported and that the quality of reporting
varies dramatically by State. I would like to know what the FDA
is doing and planning to do to improve reporting of the
foodborne illnesses, and as part of your answer, could you
speak to what the FDA and CDC are doing to improve capacity at
the State and local level to detect and track outbreaks?
Mr. Taylor. The surveillance of foodborne illness, of
course, is CDC's responsibility, and they are charged in FSMA
with improving foodborne illness surveillance. As I indicated,
we work very closely with CDC on the early detection of
outbreaks but the ability to respond to outbreaks is very much
a function of what State health department capacity is because
most of the legwork in a foodborne illness outbreak is done by
State and local health departments, and they have suffered
their own budget cuts. So there is a real resource sort of
infrastructure problem in our ability to detect and oversee and
then estimate the frequency of foodborne illness, and again,
CDC manages that part of the food safety system but we are
dependent on it and place the importance on it as much as
anybody.
Mr. Green. Like my colleague, our chairman emeritus, I am
concerned about not having the resources to do your job, and is
this delay for the last 3 years now, is that because of some of
the lack of resources that Congress may not have applied?
Mr. Taylor. No, sir. I think the time it has taken is a
function of the complexity of the process, and we have deployed
our people and put great----
Mr. Dingell. [Inaudible.]
Mr. Green. I would be glad to yield.
Mr. Dingell. [Inaudible.]
Mr. Green. And I appreciate the Chair's patience. Sometimes
some of us support a unicameral Congress instead of having two
bodies.
Mrs. Blackburn. The gentleman yields back.
Mr. Taylor. Can I just clarify the point that I wanted to
make about this? By redeploying people within FDA and the
resources we have gotten from Congress, we can issue the
regulations. You know, we can put the rules on the books. Where
we are lacking resources and where the fees would be essential,
the additional resources, is in implementing the rules, and
that is where we get the food safety and economic benefit if we
implement the rules that are envisioned and intended to have
this modern preventive system. And that is where we have the
big funding gap for FSMA is the implementation of the rules
once they are promulgated.
Mrs. Blackburn. OK. The time for the gentleman from Texas
expired. I recognize myself for 5 minutes.
Mr. Taylor, we are all concerned about the implementation
and what that structure would look like, and of course, a risk-
based structure makes sense but I think that what we know is
that 1 percent of the domestically produced commodities account
for 95 percent of the illnesses, and those commodities should
clearly be the focus of any risk-based system, and I think that
part of our concern is why you have chosen to broadly regulate
commodities that have not been associated with human foodborne
illnesses.
Mr. Taylor. So let me give you a little bit of--this is in
the produce context, I think, and----
Mrs. Blackburn. Yes, it is.
Mr. Taylor. And do I have to respectfully say I am not sure
the basis for the 1 percent, 95 percent point, but I would be
happy to have dialog about that.
There is no question that there are some commodities that
have been more associated with significant outbreaks that we
have been able to detect and that CDC has reported than other
commodities. There is no question about that. One important
point is that our ability, as we have been discussing, to
detect illnesses and outbreaks is limited by lack of resources,
so there is greater underreporting of illnesses that occur.
What food safety experts recognize and what Congress
recognized in passing the law is that when it comes to produce,
if you don't pay attention to the quality of the water, the
safety of the water you put on the produce that people are
going to eat or you don't pay attention to the basic hygiene of
the workers handling the food, you know, if you don't pay
attention to what is happening when fertilizers are added that
can potentially be carriers of pathogens, you know, Congress
identified these basic vectors of possible contamination and
directed us to establish standards that are reasonably
necessary to prevent the introduction of reasonably foreseeable
hazards. So it is a prevention syndrome. It is not a response--
--
Mrs. Blackburn. Right, and I----
Mr. Taylor [continuing]. To outbreaks, you know, regime in
FSMA. And so that----
Mrs. Blackburn. I appreciate that, but talking to my
Tennessee farmers about the produce safety rule, they are very
concerned with the lack of flexibility. Now, I was pleased to
hear you tell Mr. Walden that you are going to do a revisit on
the water rules because you do have to take into account the
regional and the local water supply issues that are there, but
I think it is important, and I wish that you all would consider
the relative risk and the comparative benefits associated with
regulating some of these individual commodities. I will tell
you, some of the rules are a head scratcher, and I will give
you an example. Kale listed as a commodity and noted never
consumed raw.
Mr. Taylor. We learned through the comment process, and so
that----
Mrs. Blackburn. Well, I was going to offer to make a kale
salad for you, so I think it is interesting, those are the
things that you read and it causes you to wonder if those that
are writing these rules have ever set foot on a farm or if they
have ever been to a Farm Bureau dinner where everyone is
bringing their favorite dish and enjoyed some of these
wonderful items. So I hope that listening to the questions that
we are asking that it points up some of the things that we need
to be bringing to your attention.
Mr. Taylor. Sure.
Mrs. Blackburn. And through the comment period, we know
that you are going to come up with some of these.
I think that another thing, before my time expires, that I
want to highlight with you is the factors or standards that the
FDA used to establish its list of covered or exempt produce.
This is something that has been questioned is, how you all came
about those and what list would be regularly reviewed. So just
know that all of that is on our list and we are going to
continue to conduct oversight very carefully, and with that, I
will yield back the balance of my time, and Mr. Griffith, you
are recognized for 5 minutes.
Mr. Griffith. Thank you, Madam Chair.
Thank you for being here this morning. In the FSMA law,
Congress specified that facilities should identify reasonably
foreseeable hazards, but my understanding is, in the proposed
rules, the FDA is using ``reasonably likely to occur'' in the
proposed preventive controls use. This language is different
from law and forces the food industry to shift from focusing on
what will occur to what can occur. Does in fact FSMA use
``reasonably likely to occur'' as a basis to define the
threshold for determining preventive controls?
Mr. Taylor. That is not the term used in the statute. It
comes from our experience with HACCP preventive controls, but
again, we have heard a lot about this issue and I think we have
a way to address this.
Mr. Griffith. OK. And I just have to point out that, you
know, I would have got in trouble. I am not a food expert. I
was a lawyer by training. But my law school professors hammered
into us the big difference between the possibilities that an
expert witness might testify to or may testify to, and the
probability, which is a different thing, and I think that is
what people are concerned about. Any of us could be hit by a
meteor, they are out there, but that doesn't mean we need to be
taking evasive action when I cross the street from this
building to the next.
Mr. Taylor. Yes, sir.
Mr. Griffith. Likewise, if there is a probability, I do
need to be watching out for those cars that are coming down the
road.
Mr. Taylor. Understood.
Mr. Griffith. And so I do appreciate that.
Also I am concerned, I just want to make sure that I have
got this clear that, you know, I represent a rural area of the
country, and I want to make sure that all my small farmers
aren't getting into any kind of headaches and hassles that
would close them down. It is my understanding that if you are a
farmer who is growing fruits and vegetables and you are selling
directly to the end-use consumer, that unless you have sales of
$500,000 a year on average over 3 years, that you are not
covered by these rules. Is that correct?
Mr. Taylor. That's correct.
Mr. Griffith. All right, and I do appreciate that.
Likewise, for people that are canning vegetables, making
jams, or manufacturing honey for farmers markets and local
consumption, am I correct also that they would be exempt from
the preventive control rules?
Mr. Taylor. If they have sales below that $500,000
threshold, yes, sir.
Mr. Griffith. All right. Are there new requirements that
these smaller farmers or the farmers who are selling right at
their farm or at the roadside stand or at the farmers market
that they would have to meet in order to be in compliance with
FDA's implementation of FSMA?
Mr. Taylor. For produce growers who are exempt under this
provision, the only thing they are required to do--this is by
statute, by the law itself--is post information about their
location so that their direct-to-consumer customer can come
back to them if they have a problem.
Mr. Griffith. OK. And I appreciate that. I also will tell
you that I appreciated it very much in previous testimony when
you said that you all recognized that you can't have a one-
size-fits-all approach. That is very refreshing. A lot of
people are concerned both about that and about folks getting
carried away and suddenly we are shutting down the small farm
operations, and your testimony has made me feel better about
that, and I appreciate you being here, and with that, Madam
Chair, unless somebody wants my time, I will yield back.
Mr. Pitts. The Chair thanks the gentleman and now
recognizes the gentleman from Florida, Mr. Bilirakis, 5 minutes
for questions.
Mr. Bilirakis. Thank you very much. I appreciate it. I was
over at the other hearing.
Mr. Taylor, I just wanted to follow up on an earlier
question, I believe Chairman Shimkus asked this, about food
byproducts being used for animal food. In Florida, the citrus
industry sells orange peels, as you know, and oranges that have
fallen off the tree for animal feed. I think there are large
environmental and sustainability issues that FDA may be
overlooking.
If the proposed rule drives up the cost of byproducts
converted to animal feed chain, many small and midsized
manufacturers will abandon the production of feed ingredients
and send the byproducts and waste streams to landfills. This
increases the load on landfills and decreases the available
products for animal food feed, thereby increasing the cost.
So my question is, will the FDA perform an environmental
impact analysis before the final rule?
And again, I want to ask this as well: Can FDA quantify the
benefits of their proposal?
Mr. Taylor. Sure. So with respect to the environmental
impact statement, we are doing an environmental impact
statement on the produce rule, and so that will accompany and
parallel the rulemaking process and we will have that before
the final rule. But on the specific issue, it is not our
intent--and we are going to work hard based upon input we
received from the community to disrupt these established
practices of byproducts of human food production going into the
animal feed system. I mean, that is an important part for
reasons you have recited of our food system, so it is not our
intent and we don't think from a food safety standpoint that
would be necessary or appropriate.
So this is the kind of issue that arises during the
rulemaking where we get comments, and I think we will work to
harmonize the produce and preventive control rules to prevent
outcomes that just don't make common sense. I mean, we are
guided by common sense here, and I think this is an issue that
is very manageable within the FSMA regime.
Mr. Bilirakis. OK. Very good. Thank you. I will move on to
the next question.
With regard to cybersecurity, the proposed rule would
require all mandatory records to be made promptly available to
the FDA upon oral or written request. Is that correct?
Mr. Taylor. Yes.
Mr. Bilirakis. OK. If the FDA requires these records to be
submitted electronically and reviewed remotely, how will the
FDA validate that the requests are coming from authorized
representatives, and more importantly, can you guarantee that
the system will be safe from hackers or leaks?
Mr. Taylor. So the first point is, it is a work in progress
and we need to work with the industry to figure out how we
exchange information in a way that is most efficient for our
collective purpose of protecting food safety, and so this is
something we have to do in dialog with the industry including
with respect to electronic transfer of records.
To the extent that records are transferred electronically,
we absolutely have to protect the confidentiality of records
that are confidential business information, and we have a lot
of experience doing that with conventional records within our
food program. There is a lot of experience elsewhere in FDA
with electronic submission of data and the drug approval
system. So I commit to you, there is no lack of sensitivity to
the importance of protecting confidentiality of data. We have a
lot of experience doing it, and it is something we will work
with the industry to be sure we do right in this context as
well.
Mr. Bilirakis. Thank you. My last question, Mr. Taylor:
Florida has a significant number of beekeepers, as do other
States. The beekeepers and honey production industry, along
with others, have been victims of various illegal trade schemes
perpetrated mostly by Chinese exporters. As a result of these
trade challenges, a lot of adulterated products, such as honey,
have entered the United States undetected. While imports are
the responsibility of Customs and Border Protection, I
understand that, once adulterated products enter into the
stream of the U.S. commerce, it becomes the responsibility of
FDA. Is that correct?
Mr. Taylor. That is correct.
Mr. Bilirakis. OK. I would like to know what FDA is doing
to combat economically motivated adulteration, FDA's proposed
rule on ``mitigation strategies to protect food against
intentional adulteration'' did not include economically
motivated adulteration within that rule and FDA will address it
under a separate regulatory scheme. My question is, Could you
explain to me how FSMA changes FDA's enforcement authority with
respect to economic adulteration, and how it will improve FDA's
enforcement over economically adulterated products, such as
honey?
Mr. Taylor. Good but complicated question. We will be
addressing intentional adulteration for economic purposes in
the preventive controls rule. It is a challenge to do that,
because in that preventive controls framework, we don't want to
require the processor to control that which can't be
anticipated, whether it is reasonably likely to occur or
probable to occur, regardless of the language you use. We have
got to sort of focus on what we expect of processors. So we had
the melamine in pet food problem a number of years ago. It was
imports from China. You know, that sort of intentional
adulteration for economic purposes where you have got a past
history of that problem occurring we think can be addressed
through the preventive controls rule, but there is a whole
array of economic adulteration issues that are going to have to
be addressable through other means as a practical matter, and
so we do provide guidance about what is appropriate in certain
products. We take limited enforcement action within our
resources. If it is not a safety issue, it necessarily ranks
lower in our priorities in terms of deploying our inspection
and enforcement responses. But there are things we can do and
have done, and we know the concerns in the honey industry and
we have had dialog, and we look forward to working further.
Mr. Bilirakis. Just a follow-up, has FDA, is there a
national standard, have they created a national standard as far
as determining whether there is adulteration? If they have not,
why haven't they?
Mr. Taylor. Well, there is not a national standard of
identity that I think some people have asked us to establish
that we have not done to date. There are standards and we have
acted on if they are illegal pesticide residues or antibiotic
residues, which sometimes happens in honey. We have taken
action. We can take action under current law. We don't need any
new laws or regulations to take action there. It is more a
matter of being able to detect these and invest resources to do
the enforcement actions.
Mr. Bilirakis. Are you in favor of creating a national
standard?
Mr. Taylor. I think in concept, we see the usefulness of
it. Frankly, it is a priority and resource challenge for us,
and so we are looking at other ways to try to address this and
again welcome working with the industry.
Mr. Bilirakis. I really appreciate it. Thanks for the
testimony.
Mr. Pitts. The Chair thanks the gentleman.
Mr. Bilirakis. I yield back. Thank you.
Mr. Pitts. The Chair now recognizes the gentlelady from
North Carolina, Ms. Ellmers, 5 minutes for questions.
Mrs. Ellmers. Thank you, Mr. Chairman, and thank you, Mr.
Taylor, for being with us today.
I have a question about, as the rules are being implemented
and the scope and the breadth of the rules, to me it is
foreseeable that there may be some discrepancies, and I am
concerned, and I hope you can expand on the process that can
take place if a grower or producer is basically disputing or
disagrees with inspectors' conclusions or the interpretation of
the rules, will the FDA provide a centralized timely mechanism
for those growers or processors to appeal the FDA? I don't even
know. It may not have even gotten that far yet.
Mr. Taylor. Well, we are not to the point where we have
rules that we are enforcing but we are very sensitive to the
fact that in the produce arena, we are regulating on farms in a
way we haven't done before, and so we know we have to be sure
our people are especially trained to understand and work in the
farm environment, and we have to be very careful, particularly
in the early years, that we understand what the expectations
are, we have communicated that to growers, and then we make
consistent decisions when we do see problems, and so there
needs to be a process to connect that person who is on the farm
with the subject matter experts and others who can be sure we
make good, consistent decisions. The Commissioner announced
earlier this week some major changes in the way we work
internally within FDA to link, you know, our headquarter
centers and decision makers with our field force in a much more
vertically integrated way to address this very issue of, do we
have the right training, the right oversight and making the
right, consistent decisions. So it is something we are very
sensitive to as we look forward to implementing the produce
rules.
Mrs. Ellmers. Well, do you know, and are there plans for
basic comprehensive or directive as far as an appeal process?
Mr. Taylor. Sure. We already have processes in the chain of
command through our field organization but we think produce is
going to require some special vehicles. Again, we are going to
be implementing these produce rules in close collaboration with
States, and in fact, we envision that it is the State agencies
that would be the primary frontline interface with growers. We
expect to be on farms actually to a very limited extent. We
don't have the resources, and we think that the States have
real advantages in their local knowledge and expertise. So we
need to work with our State partners. We met with the National
Association of State Departments of Agriculture just earlier
this week and we are working hard with them to figure out how
we will be prepared to partner with them to do this work, so
there is a lot of work to do to put this implementing system in
place.
Mrs. Ellmers. So you do foresee it as a partnership rather
than a jurisdictional issue? Because I know we have run into
that problem before.
Mr. Taylor. It has to be. I mean, Congress has mandated
that we have a national integrated food safety system, has said
that we should work with State agencies on produce oversight in
particular. We are working hard to build that system. That is
the only way we will be successful, we think.
Mrs. Ellmers. Thank you, Mr. Taylor. I yield back the
remainder of my time.
Mr. Pitts. The Chair thanks the gentlelady and now
recognizes the gentleman from Kentucky, Mr. Guthrie, 5 minutes
for questions.
Mr. Guthrie. Thank you, Mr. Chairman, and thank you for
coming today.
I have a specific question that has been brought up in my
peculiar--not peculiar to my district--but my understanding is
that the proposed rule would apply to facilities that
manufacture, process, pack or even hold animal food so they
would be required to register it as a food facility under 415
of the Food, Drug, and Cosmetic Act if they fit that category,
my understanding is, so the question is distilleries. I know
alcohol is exempted from this particular section but the
byproducts, so they are not manufacturing food but they take
the corn, they take the mash and do their formula and distill
off the alcohol and then the remaining is actually good protein
corn because they use the best corn in the world, and so
farmers do buy that. And so the question is, would a distillery
that sells their--or any, you can do an ethanol plant, you can
sell their byproduct as animal food required to register under
415? And that is a concern they have.
Mr. Taylor. Yes, the registration requirement--I am turning
to my colleague because I don't want to give you the wrong
answer, and we know this is an issue in the FSMA
implementation, but the registration requirement was actually
established as a result of the Bioterrorism Act of 2002 and
regulations FDA issued back then, but it is significant for
FSMA because the requirement to implement preventive controls
applies to firms that are required to register under the
Bioterrorism Act, and so there is a lot of interaction there
and complexity, and frankly, I will have to get back to you on
whether the current provisions of our registration requirements
apply to the distillery that is producing the byproduct that is
going to animal feed.
Mr. Guthrie. Yes, they are selling the byproduct instead of
to discard it.
Mr. Taylor. Understood. But again, I think it is an issue
that has come up in the FSMA rulemaking: how does the
preventive control regime for animal feed apply to just that
sort of situation. So this is an issue we will have to resolve
in a practical way and again, the whole goal here is to achieve
the food safety goal without imposing regulation just for
regulation's sake, so we will have to figure out what the right
practical answer is to be sure that the animal feed safety
issue is being addressed in the most practical way.
Mr. Guthrie. Yes, I know it is very specific, so your
getting back to me is a fair very point.
Mr. Taylor. Yes, sir, we will do that.
Mr. Guthrie. Thank you.
Mr. Pitts. The Chair thanks the gentleman and now
recognizes the gentleman from Georgia, Dr. Gingrey, 5 minutes
for questions.
Mr. Gingrey. Mr. Chairman, thank you very much for holding
today's hearing. I would like to welcome our witness, Mr.
Michael Taylor, from the FDA.
Mr. Chairman, I understand that our witness served
yesterday as a panelist at one of the sessions of the 2014
National Association of State Departments of Agriculture winter
policy conference in Reston, Virginia, and the topic was very
similar to what we are discussing here at this hearing.
During the Q&A portion of that session, my home State of
Georgia Commissioner of Agriculture Mr. Gary Black pursued a
line of questioning where he felt he received incomplete
answers. I think it was just a lack of time, and I would like
simply to follow up on that line of questioning, Mr. Taylor, if
you don't mind.
When do you expect the produce and preventive control rules
to be finalized?
Mr. Taylor. No later, based upon the current court order,
than the end of June 2015. That is our current requirement
legally, and we are working to meet that.
Mr. Gingrey. At the end of 2015?
Mr. Taylor. End of June 2015. June 30, 2015, is the current
court deadline.
Mr. Gingrey. June 30, 2015, not the end of 2015. All right.
Now, these are kind of yes or no questions, and we can go
through them pretty quickly.
Mr. Taylor. Yes, sir.
Mr. Gingrey. Is the intent of the Food Safety Modernization
Act to ensure enhanced safety of all produce, both imported and
domestic, for American consumers?
Mr. Taylor. Yes.
Mr. Gingrey. Would you care to speculate what weight the
law places on imports versus domestic produce production? Is it
fair to say that it is 25 percent import versus 75 percent
domestic, or is it equal?
Mr. Taylor. Well, I think it is the same goal. We need to
have the same assurances about the safety of imported food that
we have about domestic food. When I think about where the
innovative breakthroughs and real shifts from where we have
been historically in regulation are coming, the import system
is very much novel. You know, we have experience with
preventive controls in processing facilities in this country
through meat and poultry HACCP systems, what we have done for
seafood, but it is a big, new departure to hold importers
accountable for managing foreign supply chains and to have FDA
mandated to be much more present overseas. So imports are a big
focus of the law. I would----
Mr. Gingrey. Excuse me, because I have to watch my time,
but really again, yes or no, is it correct that the current
proposed rule for produce is focused on domestic production?
Mr. Taylor. No, that is not correct. Those rules will apply
to domestic and foreign growers who are shipping food to the
United States.
Mr. Gingrey. When do you plan to offer a rule on imports
and will that rule mirror the proposed rule for domestic
production with respect to content and ultimate impact?
Mr. Taylor. So the proposed rule on produce safety applies
to foreign and domestic growers. The proposal we published in
the summer of last year on foreign supplier verification is the
central rule mandated by FSMA for strengthening oversight of
imports because that----
Mr. Gingrey. Let me cut right to the chase here. Can you
assure farmers in Georgia and across the country that they will
not be placed at a competitive disadvantage with importers once
both the domestic and import rules are finalized?
Mr. Taylor. That is absolutely our goal, and if we get the
resources to implement the import provisions of this law, we
can achieve that goal.
Mr. Gingrey. Well, that is reassuring.
Mr. Taylor, last question, but it is a longer one. Are you
familiar with what has been coined as the BASE--this is an
acronym--approach for produce safety under the Food Safety
Modernization Act that has been promoted by my State's
department of agriculture? Are you familiar with that?
Mr. Taylor. Not the acronym but----
Mr. Gingrey. B-A-S-E?
Mr. Taylor. Yes.
Mr. Gingrey. BASE puts States in the best position to
efficiently drive the program under Federal regulations,
thereby keeping hopefully the FDA off of American farms. Do you
believe that this approach has merit?
Mr. Taylor. Yes, and we are working--it is not that we will
never be on farms but as I said earlier, we want to partner
with State agriculture departments, health departments, those
who are involved in produce safety at the State level to be the
frontline, the primary frontline presence working with growers,
overseeing growers and verifying compliance. That is absolutely
the system that we are working to develop.
Mr. Gingrey. Well, again, that is quite reassuring, and as
I conclude, for those that might not know, BASE, the B
represents borders between countries, where Federal involvement
in produce safety begins at the borders and the ports of entry.
A represents the correct role for the FDA is to audit State
programs. S represents standards set across the entire country,
and lastly, E represents, and I think you just said that, Mr.
Taylor, represents education for State regulators. BASE puts
States in the best position to efficiently drive the program
under Federal regulations, thereby hopefully keeping the FDA
off of American farms.
So I am very pleased with your response, and I see my time
has elapsed so I will yield back.
Mr. Taylor. Thank you.
Mr. Gingrey. Thank you, Mr. Taylor.
Mr. Pitts. The Chair thanks the gentleman. That concludes
the questions of the members who are present. There are other
questions that members may have that we will send to you. I
hope you will respond promptly. I hope you understand, we have
a couple of subcommittee hearings going at the same time so
members have been in and out.
Mr. Taylor. Yes, sir.
Mr. Pitts. Thank you. And I remind members that they have
10 business days to submit questions for the record. They
should submit their questions by the close of business on
Thursday, February 20th.
Very important hearing, very important issues, very
informative. Thank you very much, Mr. Taylor.
Mr. Taylor. Thank you, Mr. Chairman.
Mr. Pitts. We look forward to continuing to work with you.
Without objection, the subcommittee is adjourned. Thank you
again.
[Whereupon, at 11:48 a.m., the subcommittee was adjourned.]
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