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88–567 PDF 2014

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 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

RALPH M. HALL, Texas 

JOE BARTON, Texas 

Chairman Emeritus 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

Vice Chairman 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

CORY GARDNER, Colorado 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

HENRY A. WAXMAN, California 

Ranking Member 

JOHN D. DINGELL, Michigan 

FRANK PALLONE, JR., New Jersey 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

BRUCE L. BRALEY, Iowa 

PETER WELCH, Vermont 

BEN RAY LUJAN, New Mexico 

PAUL TONKO, New York 

JOHN A. YARMUTH, Kentucky 

SUBCOMMITTEE ON HEALTH

JOSEPH R. PITTS, Pennsylvania 

Chairman 

MICHAEL C. BURGESS, Texas 

Vice Chairman 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

MIKE ROGERS, Michigan 

TIM MURPHY, Pennsylvania 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

CATHY MCMORRIS RODGERS, Washington 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

RENEE L. ELLMERS, North Carolina 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

JOHN D. DINGELL, Michigan 

ELIOT L. ENGEL, New York 

LOIS CAPPS, California 

JANICE D. SCHAKOWSKY, Illinois 

JIM MATHESON, Utah 

GENE GREEN, Texas 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

HENRY A. WAXMAN, California (ex officio) 

(II) 

(III) 

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 

(1) 

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 thirdVerDate Mar 15 2010 15:18 Sep 29, 2014 Jkt 037690 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 F:\113-116 FOOD SAFETY ACT JKT REQ 9-25-14\113-116 FOOD SAFETY ACT PENDING
2 

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, riskbased approach to food safety, and two, acknowledges that a onesize-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. 

3 

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. 

4 

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. 

5 

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 

6 

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 

7 

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 farmVerDate Mar 15 2010 15:18 Sep 29, 2014 Jkt 037690 PO 00000 Frm 00011 Fmt 6633 Sfmt 6633 F:\113-116 FOOD SAFETY ACT JKT REQ 9-25-14\113-116 FOOD SAFETY ACT PENDING
8 

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 safeVerDate Mar 15 2010 15:18 Sep 29, 2014 Jkt 037690 PO 00000 Frm 00012 Fmt 6633 Sfmt 6633 F:\113-116 FOOD SAFETY ACT JKT REQ 9-25-14\113-116 FOOD SAFETY ACT PENDING
9 

ty 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 onthe-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 

10 

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 farmto-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. 

29 

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 

30 

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 manageVerDate Mar 15 2010 15:18 Sep 29, 2014 Jkt 037690 PO 00000 Frm 00034 Fmt 6633 Sfmt 6633 F:\113-116 FOOD SAFETY ACT JKT REQ 9-25-14\113-116 FOOD SAFETY ACT PENDING
31 

ment 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 

32 

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, riskbased 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 

33 

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 

34 

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. 

35 

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 

36 

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. 

37 

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. 

38 

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 AdminisVerDate Mar 15 2010 15:18 Sep 29, 2014 Jkt 037690 PO 00000 Frm 00042 Fmt 6633 Sfmt 6633 F:\113-116 FOOD SAFETY ACT JKT REQ 9-25-14\113-116 FOOD SAFETY ACT PENDING
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tration 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 

40 

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 impleVerDate Mar 15 2010 15:18 Sep 29, 2014 Jkt 037690 PO 00000 Frm 00044 Fmt 6633 Sfmt 6633 F:\113-116 FOOD SAFETY ACT JKT REQ 9-25-14\113-116 FOOD SAFETY ACT PENDING
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menting 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 supVerDate Mar 15 2010 15:18 Sep 29, 2014 Jkt 037690 PO 00000 Frm 00045 Fmt 6633 Sfmt 6633 F:\113-116 FOOD SAFETY ACT JKT REQ 9-25-14\113-116 FOOD SAFETY ACT PENDING
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ply—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? 

43 

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 

44 

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. 

45 

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 

46 

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 

47 

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 

48 

down. It is my understanding that if you are a farmer who is growing fruits and vegetables and you are selling directly to the enduse 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 

49 

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. 

50 

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. 

51 

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. 

52 

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 AssociaVerDate Mar 15 2010 15:18 Sep 29, 2014 Jkt 037690 PO 00000 Frm 00056 Fmt 6633 Sfmt 6633 F:\113-116 FOOD SAFETY ACT JKT REQ 9-25-14\113-116 FOOD SAFETY ACT PENDING
53 

tion 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—— 

54 

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. 

55 

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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