[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



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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

                              ----------                              
                                                                   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:]
    
    
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    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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