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52–575 PDF 2009

HEARING TO REVIEW FEDERAL FOOD SAFETY 

SYSTEMS AT THE U.S. DEPARTMENT OF 

AGRICULTURE

HEARING

BEFORE THE

SUBCOMMITTEE ON 

LIVESTOCK, DAIRY, AND POULTRY

OF THE

COMMITTEE ON AGRICULTURE 

HOUSE OF REPRESENTATIVES

ONE HUNDRED ELEVENTH CONGRESS

FIRST SESSION

APRIL 23, 2009

Serial No. 111–10

(

Printed for the use of the Committee on Agriculture 

agriculture.house.gov 

COMMITTEE ON AGRICULTURE 

COLLIN C. PETERSON, Minnesota, Chairman 

TIM HOLDEN, Pennsylvania, 

Vice Chairman 

MIKE MCINTYRE, North Carolina 

LEONARD L. BOSWELL, Iowa 

JOE BACA, California 

DENNIS A. CARDOZA, California 

DAVID SCOTT, Georgia 

JIM MARSHALL, Georgia 

STEPHANIE HERSETH SANDLIN, South 

Dakota 

HENRY CUELLAR, Texas 

JIM COSTA, California 

BRAD ELLSWORTH, Indiana 

TIMOTHY J. WALZ, Minnesota 

STEVE KAGEN, Wisconsin 

KURT SCHRADER, Oregon 

DEBORAH L. HALVORSON, Illinois 

KATHLEEN A. DAHLKEMPER, 

Pennsylvania 

ERIC J.J. MASSA, New York 

BOBBY BRIGHT, Alabama 

BETSY MARKEY, Colorado 

FRANK KRATOVIL, JR., Maryland 

MARK H. SCHAUER, Michigan 

LARRY KISSELL, North Carolina 

JOHN A. BOCCIERI, Ohio 

EARL POMEROY, North Dakota 

TRAVIS W. CHILDERS, Mississippi 

WALT MINNICK, Idaho 

———

FRANK D. LUCAS, Oklahoma, Ranking 

Minority Member 

BOB GOODLATTE, Virginia 

JERRY MORAN, Kansas 

TIMOTHY V. JOHNSON, Illinois 

SAM GRAVES, Missouri 

MIKE ROGERS, Alabama 

STEVE KING, Iowa 

RANDY NEUGEBAUER, Texas 

K. MICHAEL CONAWAY, Texas 

JEFF FORTENBERRY, Nebraska 

JEAN SCHMIDT, Ohio 

ADRIAN SMITH, Nebraska 

ROBERT E. LATTA, Ohio 

DAVID P. ROE, Tennessee 

BLAINE LUETKEMEYER, Missouri 

GLENN THOMPSON, Pennsylvania 

BILL CASSIDY, Louisiana 

CYNTHIA M. LUMMIS, Wyoming 

PROFESSIONAL STAFF

ROBERT L. LAREW, Chief of Staff 

ANDREW W. BAKER, Chief Counsel 

APRIL SLAYTON, Communications Director 

NICOLE SCOTT, Minority Staff Director 

SUBCOMMITTEE ON LIVESTOCK, DAIRY, AND POULTRY

DAVID SCOTT, Georgia, Chairman 

JIM COSTA, California 

STEVE KAGEN, Wisconsin 

FRANK KRATOVIL, JR., Maryland 

TIM HOLDEN, Pennsylvania 

LEONARD L. BOSWELL, Iowa 

JOE BACA, California 

DENNIS A. CARDOZA, California 

BETSY MARKEY, Colorado 

WALT MINNICK, Idaho 

———

RANDY NEUGEBAUER, Texas, Ranking 

Minority Member 

BOB GOODLATTE, Virginia 

MIKE ROGERS, Alabama 

STEVE KING, Iowa 

K. MICHAEL CONAWAY, Texas 

ADRIAN SMITH, Nebraska 

DAVID P. ROE, Tennessee 

CHANDLER GOULE, Subcommittee Staff Director 

(II) 

(III)

C O N T E N T S 

Page 

Neugebauer, Hon. Randy, a Representative in Congress from Texas, opening 

statement .............................................................................................................. 2

Scott, Hon. David, a Representative in Congress from Georgia, opening statement ...................................................................................................................... 1

WITNESSES

Almanza, Alfred V., Administrator, Food Safety and Inspection Service, U.S. 

Department of Agriculture, Washington, D.C. .................................................. 3

Prepared statement .......................................................................................... 4

Response to submitted question ...................................................................... 76

Boyle, J. Patrick, President and CEO, American Meat Institute, Washington, 

D.C. ........................................................................................................................ 20

Prepared statement .......................................................................................... 22

Reagan, Ph.D., James O. ‘‘Bo’’, Senior Vice President—Research, Education 

and Innovation, National Cattlemen’s Beef Association; Chairman, Beef 

Industry Food Safety Council, Washington, D.C. .............................................. 35

Prepared statement .......................................................................................... 36

Appell, Jill, Past President, National Pork Producers Council; Pork Producer, 

Appell’s Pork Farms, Inc., Altona, IL ................................................................. 43

Prepared statement .......................................................................................... 44

Krushinskie, Dr. Elizabeth A., Director of Quality Assurance and Food Safety, 

Mountaire Farms, Inc., Millsboro, DE; on behalf of National Chicken Council ........................................................................................................................... 49

Prepared statement .......................................................................................... 50

Rybolt, Ph.D., Michael L., Director, Scientific and Regulatory Affairs, National Turkey Federation, Washington, D.C. ..................................................... 52

Prepared statement .......................................................................................... 54

Gibber, Elliot P., President, Deb-El Foods; Chairman, Further Processors 

Division, United Egg Association, Elizabeth, NJ .............................................. 57

Prepared statement .......................................................................................... 59

Carpenter, Barry L., CEO, National Meat Association, Oakland, CA ................ 62

Prepared statement .......................................................................................... 63

SUBMITTED MATERIAL

Pacelle, Wayne, President and CEO, Humane Society of the United States, 

submitted letter .................................................................................................... 75 

(1)

HEARING TO REVIEW FEDERAL FOOD

SAFETY SYSTEMS AT THE U.S. 

DEPARTMENT OF AGRICULTURE 

THURSDAY, APRIL 23, 2009

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON LIVESTOCK, DAIRY, AND POULTRY, 

COMMITTEE ON AGRICULTURE, 

Washington, D.C. 

The Subcommittee met, pursuant to call, at 2:25 p.m., in Room 

1300 of the Longworth House Office Building, Hon. David Scott 

[Chairman of the Subcommittee] presiding. 

Members present: Representatives Scott, Costa, Boswell, Markey, 

Minnick, Neugebauer, Conaway, and Roe. 

Staff present: Claiborn Crain, Nathan Fretz, Alejandra GonzalezArias, Chandler Goule, Craig Jagger, Tyler Jameson, April Slayton, 

Rebekah Solem, Patricia Barr, John Goldberg, Pam Miller, Pete 

Thomson, and Jamie Mitchell. 

OPENING STATEMENT OF HON. DAVID SCOTT, A 

REPRESENTATIVE IN CONGRESS FROM GEORGIA 

The CHAIRMAN. This hearing of the Subcommittee on Livestock, 

Dairy, and Poultry to review Federal food systems in the United 

States Department of Agriculture, will come to order. I would like 

to give just a brief opening statement. I certainly appreciate everyone being here. The subject of today’s hearing, a review of Federal 

food safety systems at the USDA, is vital and it is very, very timely. It seems that we are perpetually bombarded with news about 

foodborne illnesses and outbreaks, and the debate over reforms of 

our food safety system as a whole, not just with respect to meat 

and seafood, is ramping up very quickly here in Congress. And as 

such, this Subcommittee, along with several others in both the 

House and the Senate, have begun to discuss in more detail what 

has been working with respect to our food, our safety system, and 

just as importantly, what has not been working. 

Food safety is a major concern for American families, and preventing foodborne illnesses has to be the primary focus for all of 

the government’s food safety agencies. It is no secret that opinions 

vary widely on these issues, and I suspect we will hear a range of 

views from the Members of this Subcommittee, as well as our witnesses on the issue at large. But I would assert that, with respect 

to the operations of the U.S. Department of Agriculture and the inspections and oversight conducted by the Food Safety and Inspection Service, the system is largely working. There, of course, reVerDate 0ct 09 2002 11:26 Oct 02, 2009 Jkt 041481 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 I:\DOCS\111-10\52575.TXT AGR1 PsN: BRIAN
2

main many challenges. We in Congress need to ensure that FSIS 

and USDA have the authorities, have the resources that they require to meet those challenges. However, for the largest part, I am 

very confident in the job they are doing and hope that all of our 

constituents are as well. 

Food safety is, of course, a farm to fork problem. At every step 

in the process from animal handling on the farm to handling and 

processing, and all the way to the dinner table, there are risks of 

contamination. We all have to do our part to prevent foodborne illnesses. However, industry in conjunction with public sector partners on the Federal, state, and local levels, such as our nation’s 

public institutions of higher learning, are constantly developing 

new technologies and techniques that are improving food safety at 

every step in the process. 

So, I look forward to our discussion today, and our continued discussion in this Congress over ways we can improve our food safety 

system. I anticipate that even though many of us may have differing ideas of what directions we should take in reform this Subcommittee, and indeed the full Agriculture Committee, will continue its tradition of working together across party lines to develop 

solutions that incorporate everyone’s ideas that we can all be comfortable with. And now I will entertain an opening statement from 

our distinguished Ranking Member. 

OPENING STATEMENT OF HON. RANDY NEUGEBAUER, A 

REPRESENTATIVE IN CONGRESS FROM TEXAS 

Mr. NEUGEBAUER. Well, thank you, Chairman Scott, for calling 

today’s hearing to review the Federal food safety systems in the 

United States Department of Agriculture. At the opening of the full 

Committee hearing on April 2, Chairman Peterson announced his 

intent to drive food safety legislation. While most of the current 

food safety ideas being discussed center around the activities of the 

Food and Drug Administration, I believe it is important to closely 

examine the programs as conducted under the Federal Meat Inspection Act and the Poultry Products Inspection Act. Mr. Chairman, I am confident that observers and participants in today’s 

hearing would be interested in knowing our thoughts about how 

food safety legislation might affect livestock producers, meat and 

poultry processors, retailers, and consumers. 

Producers in my district are increasingly asking me about the 

food safety debate here in Washington and what changes it might 

bring to the food system. My district includes one of the largest cattle feeding areas in the country, several large dairy operations, as 

well as numerous small farmers who sell products at the local markets. All of them could be affected by changes from the new food 

safety legislation. From our witnesses today, I anticipate that Subcommittee Members will gain a greater understanding of our Federal food safety system, which will equip us to respond to specific 

proposals which will actually help inform our understanding of how 

programs at FDA differ from those at USDA. 

The better our understanding of the current system, the better 

our ability to weigh proposed changes. I appreciate that we will be 

taking testimony from the Administrator of the Food Safety and Inspection Service, and from witnesses speaking on behalf of both 

3

packers and producers. In my view, these witnesses are especially 

qualified to tell us what is working, what is not, and what challenges should be addressed as we proceed in this public policy discussion. Again, Mr. Chairman, thank you for having today’s hearing. I look forward to the testimony of our witnesses and the dialogue during the questions. 

The CHAIRMAN. Thank you very much, Mr. Neugebauer. Now the 

chair will request that other Members submit their opening statements for the record so the witnesses may begin their testimony, 

and to ensure that there is ample time for questions. We would like 

to welcome all our witnesses to the table. First, we have on our 

panel one, we have Mr. Alfred V. Almanza, Administrator, Food 

Safety and Inspection Service for the United States Department of 

Agriculture in Washington, D.C. Mr. Almanza, you may begin. 

STATEMENT OF ALFRED V. ALMANZA, ADMINISTRATOR, FOOD 

SAFETY AND INSPECTION SERVICE, U.S. DEPARTMENT OF 

AGRICULTURE, WASHINGTON, D.C. 

Mr. ALMANZA. Chairman Scott, Ranking Member Neugebauer, 

and Members of the Subcommittee, thank you for inviting me to 

appear before you today at this hearing to review Federal food safety systems at the United States Department of Agriculture. I am 

Al Almanza, Administrator of the Food Safety and Inspection Service at USDA, and I appreciate the interest that the full Committee 

and this Subcommittee has expressed in improving the nation’s 

food safety system. FSIS is responsible for the verification of food 

safety systems producing meat, poultry, and processed egg products, and for ensuring the equivalency of the countries shipping 

these products to the United States. 

Our agency has a long tradition of food inspection and in the 

mid-1990s transitioned to a HACCP environment, in which an individual establishment is responsible for designing and maintaining 

its food safety system. Under our HACCP environment, the agency’s responsibilities include verifying that the establishment has effectively identified hazard points in its system and has deployed 

steps to prevent and mitigate risks. Only then has the product 

from that establishment earned the mark of inspection from USDA, 

which is a symbol to the consumer that the product is safe and 

wholesome. FSIS similarly requires the food safety systems of other 

nations exporting to the United States to have an equivalent system. Importing nations must provide us with the assurances that 

their system has met our standards. 

I have submitted written testimony for the record which provides 

a great deal of detail about how FSIS operates. It describes our efforts to improve our inspection process and our public health infrastructure, which is designed to identify problems before they occur. 

But for my oral testimony today, I would like to focus on the broader issue of the current state of our nation’s food safety system. 

President Obama and Secretary Vilsack have clearly expressed a 

willingness to tackle food safety, and they are to be commended for 

taking on this difficult and challenging issue. This is a priority 

from the top and FSIS welcomes the challenge. We need to take a 

look at the risk posed by different food products and the performance of the establishments that manufacture those food products. 

4

At FSIS, we have been tasked to look at all of our regulations 

and administrative actions, inter-agency coordination, the way we 

work with state and local partners, and our coordination with foreign governments. In addition, we are reviewing our strengths and 

weaknesses and will provide suggestions on these areas needing 

improvement. An important part of the FSIS inspection role is 

verification that industry is following its food safety plan. This is 

intensive, and this is how we ensure we are holding ourselves accountable to our food safety responsibilities. 

Through internal management controls, we can identify if we are 

not meeting the mark and where there might be data gaps. Moreover, our Public Health Information System will help us identify 

sooner if we start falling behind and help us improve our accountability. We also need to ask hard questions about what level of 

verification of food safety systems is appropriate for different kinds 

of foods, what roles are appropriate for the different agencies involved in food safety, and if a uniform approach on import safety 

is needed. These questions need to be viewed through the prism of 

public health protection and risk assessment and management. 

But, we don’t need to start from scratch. There has been much 

learned about our current system as well as those of other countries. The GAO has repeatedly studied how our trading partners 

ensure food safety, most recently in 2008. It is clear that GAO believes that the expertise of other nations can provide insight on 

how to improve our own food safety system. 

FSIS welcomes the keen interest of Congress, our stakeholders, 

and the public in food safety. President Obama has formed the 

Food Safety Working Group and has charged both Secretary 

Vilsack and the Secretary of Health and Human Services with 

leading this effort aimed at making our systems more uniform, consistent, and effective. We support this pledge to strengthen and enhance our nation’s food safety system. Based on my more than 30 

years serving in the field for FSIS, I believe this agency is up for 

the challenge. 

Chairman Scott, Ranking Member Neugebauer, and Members of 

the Subcommittee, thank you again for allowing me the opportunity to be here today to discuss our current food safety system 

and future enhancements. I look forward to your questions. 

[The prepared statement of Mr. Almanza follows:]

PREPARED STATEMENT OF ALFRED V. ALMANZA, ADMINISTRATOR, FOOD SAFETY AND

INSPECTION SERVICE, U.S. DEPARTMENT OF AGRICULTURE, WASHINGTON, D.C. 

Chairman Scott, Ranking Member Neugebauer, and Members of the Subcommittee, thank you for inviting me to appear before you today at this hearing to 

review Federal food safety systems at the U.S. Department of Agriculture (USDA). 

Food safety is a priority for this Administration and this agency. I commend the 

President and Secretary Vilsack for taking on this difficult issue and making review 

of the current state of our food safety system a top priority. I also appreciate this 

Subcommittee and the full House Agriculture Committee exploring how FSIS regulates products under its jurisdiction and the larger issue of the nation’s food safety 

system. 

There is much we can draw from as we engage in this food safety dialogue. Many 

experts have studied our current system in the U.S. and that of other countries. We 

don’t need to start from scratch; there are many lessons learned that can and should 

be considered as part of this open discussion. 

As we embark on this dialogue, we all need to look at the various levels of risk 

posed by different food products, and the different performance of the establishVerDate 0ct 09 2002 11:26 Oct 02, 2009 Jkt 041481 PO 00000 Frm 00008 Fmt 6633 Sfmt 6621 I:\DOCS\111-10\52575.TXT AGR1 PsN: BRIAN
5

ments that manufacture those food products, for the entire food supply. We also 

need to ask hard questions about what level of inspection is appropriate for different 

kinds of foods, what roles are appropriate for the different agencies involved in food 

safety, and how we approach uniformity in import safety. These questions should 

be viewed through the prism of public health protection and risk assessment and 

management. 

We will support Secretary Vilsack’s pledge to strengthen and enhance our nation’s 

food safety system. He has tasked us to look at all of our regulations and administrative actions, inter-agency coordination, the way we work with state and local 

partners, and our coordination with foreign governments. In addition, we will review 

our strengths and weaknesses and provide suggestions on areas needing enhancement. We welcome your interest and this hearing today and look forward to working 

with you and all of our stakeholders. 

Who We Are and What We Do to Ensure Food Safety 

FSIS is the inspection agency within the U.S. Department of Agriculture with a 

focus on public health. It is responsible for ensuring that the nation’s commercial 

supply of meat, poultry, and processed egg products is safe, secure, wholesome, and 

accurately labeled and packaged, whether those products are domestic or imported. 

We administer and enforce the Federal Meat Inspection Act, the Poultry Products 

Inspection Act, the Egg Products Inspection Act, portions of the Agricultural Marketing Act, the Humane Methods of Slaughter Act, and the regulations that implement these laws. 

Our mission is to protect the public health. Since our long-standing statutes were 

established, our inspection process has evolved into a dynamic preventative system 

designed to address problems before they occur. However, there is always room for 

enhancement and we are always open to improvement. Mindful of our finite resources, we have to measure and attack risk, hazards, or inadequate performance 

to know where we can best focus our attention. In order to efficiently and effectively 

protect the public health, we at FSIS recognize that all food doesn’t necessarily 

carry the same risk, and all plants do not operate the same way. 

The high volume and the high-risk nature of the products that FSIS inspects demand an in-plant inspection presence, which is not only required by law, but is necessary to protect consumers. For this reason, the agency employs over 9,500 people, 

including around 7,800 full-time in-plant and other front-line personnel protecting 

the public health in approximately 6,200 federally-regulated establishments nationwide. Our statutes require us to be present for all slaughter operations and we inspect each processing establishment once per shift per day. Inspection personnel 

perform approximately nine million food safety and 1.5 million food defense 

verification procedures annually at these plants. In Fiscal Year (FY) 2008, FSIS personnel inspected about 50 billion pounds of livestock carcasses, about 59 billion 

pounds of poultry carcasses, and about 4.3 billion pounds of processed egg products. 

Additionally, FSIS personnel inspected 3.3 billion pounds of imported meat and 

poultry products at our borders. 

In addition to in-plant personnel in federally-inspected establishments, FSIS employs a number of other field personnel, such as laboratory technicians and investigators. Program investigators conduct surveillance, investigations, and other oversight activities at food warehouses, distribution centers, retail stores, and other 

businesses operating in commerce that store, handle, distribute, transport, and sell 

meat, poultry, and processed egg products to the consuming public. These in-commerce businesses do not operate under grants of inspection and are not inspected 

on a daily basis by FSIS. However, the agency verifies that FSIS-regulated products 

moving in consumer distribution channels continue to be safe and wholesome. 

Since 2000, the Hazard Analysis and Critical Control Point (HACCP) system, an 

internationally recognized method for the identification and control of hazards, has 

been required for all meat and poultry plants. Plants are responsible for identifying 

the hazards in the products they produce and determining how to minimize contamination at each step of their process. Our responsibility is to verify that plants 

are following their own food safety or HACCP plans. 

In late 2001, FSIS began an additional level of surveillance through food safety 

assessments (FSAs), further strengthening public health. These FSAs, carried out 

by highly trained scientific personnel, look thoroughly at the design of the plant’s 

food safety plan as verification that an establishment has fully assessed the relevant 

hazards and put in place controls or preventive measures that are effective. This 

more intensive review, now to be done on a routine basis, provides valuable data 

for the agency to analyze and can lead to major changes or refinements in agency 

policy. FSIS has committed to conducting routine FSAs in every plant every 4 years. 

6

Additional FSAs will be conducted as needed, for example, following positive pathogen sample results or products implicated in forborne illness outbreaks. 

Our policies at FSIS are rooted in science and based on data. Through sciencebased initiatives and efforts to continue to strengthen our infrastructure, FSIS 

works to prevent adulterated food from reaching the consumer. In 2008, FSIS personnel tested about 21,300 ready-to-eat product and environmental samples using 

risk-based criteria for Listeria and approximately 49,000 raw product samples for 

E. coli O157:H7 in ground beef and Salmonella in raw meat and poultry. To analyze 

these samples, FSIS has three labs, and supports 25 Food Emergency Response Network (FERN) labs. FERN consists of Federal, state, and local governmental laboratories, which are responsible for protecting the U.S. food supply from intentional biological, chemical, and radiological contamination. 

All products under FSIS’ jurisdiction receive the USDA mark of inspection after 

inspectors confirm its safety and wholesomeness. This is one of our most powerful 

tools in protecting the public health. Denying the mark of inspection due to insanitation or a lack of process control, for example, closes down a regulated establishment and effectively prevents the production of potentially adulterated food. 

Making the Best Use of Our Data 

In order to improve upon our preventative system of identifying the inherent risks 

of different food products and establishments, we must continue to evolve towards 

an even more science-based, data driven inspection system. This depends on building a comprehensive and integrated strategic approach to managing data. FSIS has 

long recognized this need, which has also been recognized by the Office of the Inspector General (OIG), the Government Accountability Office (GAO), Congress and 

our stakeholders. Before and since its December 2007 audit, we have been working 

closely with the OIG to strengthen our data collection and analysis capabilities. 

FSIS has enhanced data integration through data sharing, mining, reporting, and 

analysis within and across FSIS programs and other agencies. FSIS’ improvements 

include forming the Data Analysis and Integration Group (DAIG) and the Data Coordinating Committee (DCC). The DAIG is a staff dedicated to conducting data analysis and ensuring that agency data analyses are consistent, of high quality, relevant 

to FSIS’ mission and business processes, and fully integrated into ongoing decisionmaking. The DCC has members from each FSIS program office who serve as liaisons between the DAIG and the program offices. More specifically, DCC members 

coordinate the analysis of data to ensure that data is not duplicated, that data is 

used efficiently, and that analysis done in one part of the agency is available to inform the work done in other parts of the agency and other food safety partners. 

FSIS works closely with other Federal, state, and local agencies, which have a 

role in keeping the U.S. food supply safe, to coordinate food safety and food defense 

activities, including risk assessment and risk management. For example, the agency 

has a liaison to the Centers for Disease Control and Prevention (CDC) and uses 

data from the PulseNet system to monitor foodborne illness-causing bacteria; coordinates with Custom and Border Protection (CBP) to monitor product imported to the 

United States; and frequently interacts with the U.S. Food and Drug Administration 

(FDA) on mutual food safety and food defense issues. These are only a few examples. We also recognize the importance of uniform and consistent Federal food safety 

requirements for our state and local partners. 

In addition, FSIS utilizes AssuranceNet, a web-based system of management controls that pull inspection and laboratory data from the agency’s data warehouse. We 

have been creating analysis plans for directives and notices, conducting peer reviews 

of data analyses, soliciting input from stakeholders, and developing a consistent set 

of tools for conducting data analysis. In all these efforts to evolve our data management system, we are pleased with the support we’ve been given by the Administration and Congress in recognition of providing support for our information technology 

infrastructure enhancements. 

Public Health Information System 

FSIS has been working on a number of actions related to data integration and 

analysis and enhancements to the agency’s inspection program and many are nearing completion. The most significant initiative is the development of a Public Health 

Information System (PHIS) which will integrate the agency’s data systems to provide a comprehensive, fully automated system that will allow FSIS to more quickly 

and accurately identify trends, including vulnerabilities in food safety systems, and 

thus allow us to more efficiently and effectively protect public health. 

In order to satisfy the OIG’s recommendation for external review, FSIS asked the 

National Academy of Sciences (NAS) to review FSIS data initiatives in order to ensure that agency decisions are science-based and data driven. Three studies have 

7

already been undertaken by NAS. FSIS will review the input from NAS and determine whether and how to incorporate appropriate changes into PHIS. 

PHIS will integrate FSIS data sources, improve data quality and reporting consistency, enhance management controls, and ensure more efficient and effective use 

of FSIS data to inform inspection activities and develop policies that protect public 

health. This enhanced dynamic system will be a flexible, user friendly, and webbased application that replaces many of FSIS’ legacy systems built with older technology (e.g., the Performance-Based Inspection System), automates paper-based 

business processes (e.g., export certification), and can be modified to accommodate 

changing needs. 

PHIS will also revolutionize how FSIS collects and analyzes information about domestic and international food safety systems that produce FSIS-regulated products 

so that the agency can better identify food safety risks before they result in outbreaks or recalls. Using multiple FSIS data sources, analysts will be able to identify 

trends and anomalies from test results and inspection findings. 

Further, using the Predictive Analytics component of the Public Health Information System, FSIS will be able to monitor all establishment and import/export data 

points in near real time and alert the agency to anomalies, such as a large number 

of incomplete inspection activities or high rates of noncompliance in an establishment. In addition, PHIS will support automated algorithms and decision criteria for 

consistent direction of inspection activities and reporting of inspection results. 

PHIS will streamline the agency’s export program by automating paper-based 

processes, including establishment applications for approval for export, applications 

for export certificates, and the issuance of export certificates. The system will enable 

an automated edit-check capability to ensure certificates properly reflect a foreign 

country’s import requirements. The new system will allow FSIS to verify the effectiveness of foreign food safety systems and enable the advance receipt and 

verification of electronic foreign health certificates associated with arriving foreign 

shipments certified by a foreign government. 

PHIS will also automate FSIS processes for auditing the inspection programs of 

foreign countries exporting meat, poultry, and processed egg products to the United 

States. This will also serve to allow the agency to provide greater oversight to countries that stand out because of import findings or inconsistencies in their programs, 

allowing us to spend less time and resources performing our annual audits of countries that consistently meet our regulatory requirements and more time auditing 

those that do not. 

Since 2002, FSIS has actively participated in the International Trade Data System initiative, and is working closely with the Department of Homeland Security’s 

(DHS) CBP to ensure an electronic interface between PHIS and CBP’s Automated 

Commercial Environment. This long overdue initiative, when completed, will give us 

a greater level of confidence in the safety of imports and the food safety systems 

of foreign countries deemed equivalent by providing real-time exchange of import 

data between the importing community, CBP, and FSIS to ensure that appropriate 

inspections are performed and enforcement actions are taken. 

We have also provided broadband computer connections to most inspection program personnel in the field so that they are linked to a near real-time data communications infrastructure. This improved access is vital for agency personnel who are 

collecting data in the field, because it will allow them to spend more of their time 

on inspection activities. 

FSIS is leveraging USDA enterprise data centers to host the new PHIS and other 

major systems to ensure that they are readily available and are using current data. 

In addition to using a primary USDA enterprise data center, a second, geographically separate, failsafe enterprise data center will be used to ensure a consistently 

reliable system in case of disaster or disruptions in the primary facility. The agency 

is also continuing to further secure its infrastructure to protect its data and systems. 

Imports 

FSIS ensures the safety of imported meat, poultry and processed egg products 

through a three-part approach. First, FSIS establishes the initial equivalence of the 

meat, poultry, or processed egg inspection system of a country that wishes to export 

to the United States. Second, as I mentioned, we verify continuing equivalence of 

the foreign system through annual audits. Finally, FSIS import inspectors perform 

re-inspection of shipments of meat, poultry, and processed egg products at the border, including statistically-based random sampling that is intended to verify the effectiveness of the foreign inspection system. 

This country-to-country approach to food safety is an efficient and effective means 

to ensure the safety of imported products and illustrates that our trading partners’ 

8

governments have appropriately invested in and exercised control of their food safety infrastructure. PHIS will also connect with participating foreign governments, 

which will enable electronic certification of shipments to the United States. This is 

an important additional control for import safety. 

Equivalence is the foundation for our system of import safety. The equivalence 

principle recognizes that an exporting country can employ different sanitary measures than the U.S. to address food safety hazards if the country can objectively demonstrate that its safety measures achieve the same level of public health protection 

as the measures used by the United States for its meat, poultry, and processed egg 

products. 

Once the imported product enters this country, FSIS’ field force of program investigators provide ongoing surveillance of product in commerce to protect the public 

from illegally imported and smuggled meat, poultry, and processed egg products. 

We take great pride in FSIS’ equivalence system for imported food under its jurisdiction. By working with the government of each foreign trading partner, rather 

than individual establishments, we can ensure that imported products under FSIS’ 

jurisdiction meet standards that provide the same level of protection as that provided by FSIS inspection of domestic products. Further, we can use resources more 

efficiently and effectively when working with our counterparts in other countries. 

Fighting Foodborne Pathogens 

Earlier, I hinted at some of the steps that FSIS has taken to tackle foodborne 

pathogens, and I’d like to elaborate on that a little. FSIS works in collaboration with 

CDC, FDA and state and local public health partners to investigate foodborne illness cases and outbreaks. One specific collaborative effort is FoodNet (the 

Foodborne Diseases Active Surveillance Network), a part of the Emerging Infections 

Program at the Centers for Disease Control. FSIS worked in conjunction with CDC, 

FDA, and epidemiologists and public health laboratories in several states to establish FoodNet in 1996. FoodNet conducts active surveillance of foodborne diseases, 

case-control studies to identify risk factors for acquiring foodborne illness, and surveys to assess medical and laboratory practices related to foodborne illness diagnosis. It also provides estimates of foodborne illness and sources of specific diseases 

that are usually found in the United States and interprets these trends over time. 

FSIS uses the data that are generated to analyze the effectiveness of its Pathogen 

Reduction/Hazard Analysis and Critical Control Point (PR/HACCP) rule and other 

regulatory actions, as well as to develop public education initiatives. 

FoodNet data are used by the agencies that are involved to evaluate progress toward meeting the Healthy People 2010 and Healthy People 2020 national objectives 

for foodborne infections. FSIS and FDA are co-lead agencies responsible for the HP 

2010 food safety objectives. Of the infections tracked in this category, most, but not 

all, are transmitted by food vehicles, including drinking water, and many are transmitted by foods not regulated by FSIS. We recognize that the most recent surveillance data on foodborne disease outbreaks from the Centers for Disease Control 

shows that progress toward Healthy People 2010 objectives has plateaued, and that 

the incidence of the most common foodborne illnesses has changed very little over 

the past 3 years. This is troubling to us, and we believe the report points to the 

need for better information about which foods contain pathogens that are sources 

of infection. 

We have taken many aggressive actions to combat E. coli O157:H7. For example, 

we now have more targeted routine testing, we are testing more ground beef components, we refined the testing method, and we have released draft compliance guidelines for industry. We have also held several public meetings to discuss the challenges posed by E. coli O157:H7 and to work on solutions with industry, including 

small plants, consumers, and other public health partners. Those discussions have 

helped us begin developing directives and policies to address our new steps for the 

future. 

We are also pleased to report that we have seen improvement in the data trends 

as a result of the Salmonella initiative and verification testing programs. Furthermore, FSIS is analyzing the data on Salmonella and Campylobacter contamination 

from a recently completed microbiological baseline study of broiler carcasses and deciding how to proceed based on that data. 

We have implemented policies to control Listeria monocytogenes (Lm) in ready-toeat (RTE) products. The agency has a zero tolerance policy for this pathogen in RTE 

products and FSIS requires that establishments producing RTE products address 

Lm through a written program, such as their HACCP plan or Sanitation Standard 

Operating Procedures, or other prerequisite programs. 

FSIS scientists continue to stay abreast of new developments in the area of microbial food safety and inform agency management of potential policy implications. 

9

I do want to be clear that our routine Salmonella testing data is not a measure 

of true national prevalence—that is why we conduct periodic baseline studies. We 

have completed a new broiler baseline study, from which we plan to estimate national prevalence data. Our intent is to continue to drive down human illness rates, 

to drive down percent positive rates in verification samples, and to reduce the national prevalence of Salmonella as estimated by baseline studies. However, without 

accurate data attributing illness to specific foods, defining meaningful performance 

objectives remains challenging for regulators. Attribution is absolutely critical. 

Recalls 

Recalls are the last weapon that FSIS uses to combat foodborne illness and protect public health. The purpose of a recall is to remove meat or poultry from commerce as quickly as possible when FSIS has reason to believe it is adulterated or 

misbranded. Just as we approach preventing a recall in a proactive way, FSIS is 

also proactive in overseeing recalls once they become necessary. 

I cannot stress enough that, even though recalls are voluntary actions, they are 

the result of active oversight and intervention by our agency. Moreover, we are open 

to any ideas that will strengthen our food safety system recall process. 

The agency issues recall information as quickly as possible to the public, stakeholders and public health partners. Also, we have begun translating more of the recall releases into Spanish. Individuals can subscribe to receive automatic e-mail notification of recall updates, including press releases, directly from FSIS’ website at 

www.fsis.usda.gov, as well as RSS (Really Simple Syndication) feeds. 

After the recall occurs, FSIS conducts effectiveness checks to ensure that consignees have received notice of the recall and are making reasonable efforts to retrieve and destroy the recalled product or return it to the recalling firm. Upon compliance, the recalling firm is officially notified by letter that the recall is completed, 

and no further action is expected. 

Last year, in order to improve the effectiveness of a recall, FSIS also began to 

make available to the public a list of retail establishments that have likely received 

products subject to the recall. FSIS believes this information helps consumers lower 

their risk of foodborne illness by providing more information that may assist them 

in identifying recalled products. Interested individuals can also subscribe on the 

FSIS website to get e-mail alerts about the retail distribution lists. 

Training and Education 

FSIS can only achieve its public health, food safety, and food defense missions 

with a well-prepared workforce; therefore, training is one of our top priorities. 

Through scientific and technical training that reflects the agency’s science-based approach to food safety and food defense, we can accomplish this. FSIS has made a 

number of improvements in employee training, thereby increasing workforce capability and advancing our public health goals. In addition, FSIS training is accredited 

by the International Association for Continuing Education and Training, qualifying 

our training programs to award continuing education units (CEUs) to participants 

who successfully complete courses. 

FSIS has made substantial progress in improving its workforce training program. 

Some key milestones demonstrating improvement include establishing a new curriculum based on food safety and public health; implementing training as a condition of employment; launching a comprehensive management, leadership and development program based on the Office of Personnel Management’s competencies to 

meet the need for succession planning; introducing a regular process to provide 

training that coincides with the issuance of key agency policies; building capacity 

for follow up training and education through distance learning; achieving greater 

flexibility with training contracts; establishing regional training bringing courses 

closer the worksite; and evaluating the effectiveness of training through pre and 

post testing. 

We also recognize the importance of partnering with industry by sharing our 

training materials and conducting training and education sessions for industry and 

inspection personnel in the same room together. This approach keeps industry current on our training methods and materials and leads to greater compliance by industry through a better understanding of the Federal requirements. 

The best asset that FSIS has is a dedicated workforce. With FSIS being the largest Federal employer of veterinarians, the agency has developed new recruitment 

and retention strategies to retain those employees who have a passion for food safety and public health and to attract others to join us in protecting the public health. 

As a result of our efforts, agency in-plant personnel vacancy rates are declining. At 

the end of FY 2008, FSIS had more in-plant inspection personnel than at any time 

since 2001. Even with these strategies, the future of the workforce will need a high 

10

degree of technical and analytical skills in order to address emerging pathogens and 

problems. 

Where We Go From Here 

Mr. Chairman and Members of the Subcommittee, President Barack Obama and 

Secretary Tom Vilsack have clearly expressed a willingness to tackle food safety and 

they are to be commended again for taking on this difficult and challenging issue. 

This is a priority from the top, and FSIS is up to the challenge. 

For its part, FSIS will continue along the lines I’ve described here today—to improve its public health infrastructure designed to address problems before they 

occur. 

But that is not enough. The President and the Secretary have laid a challenge 

before us, and we need to engage in the dialogue now opened to take a look at the 

risk posed by different food products, and the performance of the establishments 

that manufacture those food products, for the entire food supply. We also need to 

ask hard questions about what level of inspection is appropriate for different kinds 

of foods, what roles are appropriate for the different agencies involved in food safety, 

and if a uniform approach on import safety is needed. The President has established 

a Food Safety Working Group to conduct a thorough review of food safety systems. 

There has been much written about our current system, as well as those of other 

countries. The GAO has repeatedly studied how our trading partners ensure food 

safety, most recently in 2008. It is clear that GAO believes that the experiences of 

nations such as Canada, the European Union, Germany, Ireland, Japan, the Netherlands, and the United Kingdom can provide insight on how to improve our own food 

safety system. 

FSIS recognizes the keen interest of Congress, our stakeholders, and the public 

in food safety. We support the President’s pledge to strengthen and enhance our nation’s food safety system. Based on my more than 30 years serving out in the field 

for FSIS, I believe this agency is up for the challenge. 

Chairman Scott, Ranking Member Neugebauer, and Members of the Subcommittee, thank you again for allowing me the opportunity to be here today to discuss our current food safety system and future enhancements. I look forward to your 

questions.

The CHAIRMAN. Thank you very much, Mr. Almanza, and we will 

now start our questioning. I am going to yield my time, and give 

some time to Mr. Boswell, who has to catch a flight. You are recognized, Mr. Boswell, for 5 minutes. 

Mr. BOSWELL. Thank you, Mr. Chairman. I appreciate you being 

here to share with us today. A couple of things that are on my 

mind. Recently, I was involved with a trip to Vietnam, which you 

are probably aware of, looking facilities over, and it just brings to 

mind during our full Committee hearing on food safety a few weeks 

ago, we asked the witnesses about catfish. Dr. Murano, former 

Under Secretary of Food Safety for USDA, explained that catfish 

is a muscle meat, and she expects that FSIS will apply the same 

food safety principles to catfish as the agency does to meat and 

poultry. 

So my question is do you agree with Dr. Murano’s assessment of 

catfish, and will FSIS be applying the same food safety principles 

to catfish as to meat and poultry? 

Mr. ALMANZA. Yes, sir. I don’t have any reason to believe that 

we would not. 

Mr. BOSWELL. Okay. Thank you. Does catfish fit well in a 

HACCP-based system? 

Mr. ALMANZA. Yes, sir. It does fit perfectly into the HACCP principle type of inspection. 

Mr. BOSWELL. Okay. Thank you. And what are the differences 

between what will be FSIS’ HACCP, that is a lot of letters, for catfish and the HACCP system that is currently in place for other seafood? 

11

Mr. ALMANZA. Well, most importantly, we would provide daily inspection as we do with meat and poultry inspection, which is a continuous presence in each establishment. 

Mr. BOSWELL. Thank you. The recent farm bill mandated that 

catfish inspection be transferred from FDA to your agency. Where 

are you in the implantation process, and do you think that FSIS 

should inspect all seafood products? 

Mr. ALMANZA. Currently, the catfish inspection is in rulemaking, 

and in response to your second question, that is something that 

would probably be decided at a level much higher than mine. 

Mr. BOSWELL. Well, I appreciate that, and thank you for being 

with us today, and we will look forward to our continuing dialogue 

on this subject. 

Mr. ALMANZA. Thank you. 

Mr. BOSWELL. Thank you, Mr. Chairman. I yield back. 

The CHAIRMAN. Thank you. The chair will now recognize the 

Ranking Member, Mr. Neugebauer, for 5 minutes. 

Mr. NEUGEBAUER. Thank you, Mr. Chairman. Thank you for 

holding this hearing. Mr. Almanza, in your tenure at USDA, has 

any company ever refused a request to recall a product? 

Mr. ALMANZA. Not that I am aware of. 

Mr. NEUGEBAUER. Under a mandatory recall system, favored by 

some, if food is recalled on the basis of adulteration should the government require first to prove that the product is adulterated or 

should the recall just go ahead and happen? 

Mr. ALMANZA. Well, first of all, for it to be in a Class I recall situation, it would have to be adulterated for us to engage in a recall, 

yes, sir. 

Mr. NEUGEBAUER. Can you kind of walk me through the process 

of, once you perceive there is a problem, what your agency does to 

interact under that scenario of a product that is thought to be adulterated? 

Mr. ALMANZA. Okay, sure. What we do is we have a recall committee, and it is comprised of different parts of our agency. We look 

at what occurred within the facility, what the product is, whether 

the risk is an imminent risk. So, we kind of look at all the different 

facets to what the product is and the adulterant or whatever. It 

may be something else. It may be something that just affects its 

usability, and so the recall committee goes through a process to determine whether or what caused the recall. Obviously, if it is an 

adulterated product that would then be a Class I recall and all the 

product would be recalled. 

Mr. NEUGEBAUER. And how do you determine the scope of that 

recall? 

Mr. ALMANZA. Well, it just depends on what products were affected by—if it is just, for example, if it is ground beef and we have 

determined that it is adulterated, then we would go back to the 

producer and get the records of where the product was distributed, 

and then recall it from there. 

Mr. NEUGEBAUER. One of the things that I am hearing from 

some of the people in processing is that, increasingly, the agency 

is dealing with them on a directive basis rather than coming out 

with rulemaking, and having a comment period. They are concerned that normal policies are not being followed in the sense that 

12

when the agency is taking a change in direction that you are kind 

of circumventing due process. What would your response to that 

be? 

Mr. ALMANZA. I would say that we have—‘‘transitioned’’ is probably a good word—into adapting to different things that are occurring within the industry. For example, when we first started with 

HACCP, HACCP was new. We implemented it, and certainly we 

knew that it would not be elastic and things have occurred. The industry has adjusted to some of the things that we have done. And 

so it has been an adjustment period in my opinion for both, for the 

industry and for us as regulators. 

Mr. NEUGEBAUER. Do you think that it can be done better? 

Mr. ALMANZA. Oh, absolutely. Yes, sir. 

Mr. NEUGEBAUER. Well, the concern I have is a lot of times in 

the government we tend to start trying to be the sheriff instead of 

working with the industry, who probably have an equal amount of 

expertise in that process. I think what everybody is interested in 

is food safety, both the people that are involved in the production 

and processing of food. And when we leave them out of that process, I don’t think we would get a better result. So, I would hope 

that in the future that we would get back to looking to the industry 

to come to the table, coming up with a rulemaking process that allows input into that, instead of the agency being the person that 

believes that they know what is best for the food safety, because 

we miss 50 percent or more of the knowledge base in that process. 

I have to tell you I was extremely disappointed that we have 

moved away from that kind of activity. With that, Mr. Chairman, 

I yield back. 

The CHAIRMAN. All right. Thank you, Mr. Neugebauer. Mr. 

Almanza, let me ask you this question. GAO says that there are 

a total of 15 agencies collectively administering 30 laws related to 

food safety, though primarily they fall under FSIS and FDA jurisdiction. My question is does inspection work when there is more 

than one government entity responsible for food safety?. 

Mr. ALMANZA. Does it work? I think it works. What I think we 

need to get to is we need to look at risk, public health and food 

safety, and let that be the driver and have a more uniform system. 

When you look at product risk and you look at a risk ranking of 

where different products stand in a risk ranking, that is probably 

the key for the level of inspection, the amount of inspection, the intensity of inspection because it doesn’t really matter, in my opinion, 

the number. It is the uniformity of how the inspection is applied. 

The CHAIRMAN. Tell us what do you mean by high risk products, 

what is that? 

Mr. ALMANZA. I think that there are different products that have 

a higher risk to cause foodborne illness. 

The CHAIRMAN. Could you give us some examples? 

Mr. ALMANZA. Well, there are some that the current things that 

we have had with E. coli, with ground beef, some of the Listeria 

monocytogenes outbreaks and some Salmonella outbreaks. When 

you start looking at the products that are involved in some of those 

situations then there would be some higher level of risk to those 

rather than say some canned products that carry minimal risk. 

The CHAIRMAN. So you are saying beef is a high risk product? 

13

Mr. ALMANZA. I wouldn’t say across the board it is, no, sir. There 

are certain products derived from some beef not beef as a whole. 

The CHAIRMAN. Poultry? 

Mr. ALMANZA. With poultry, there is some Salmonella but that 

is raw poultry, and so you have to look at the different food products, depending on where the risks that are involved with producing it, the risks that are involved with manufacturing it, and 

so on. 

The CHAIRMAN. So the risk is not the product as much as the 

processes that product goes through. I guess what I am trying to 

get at, what makes it the high risk product, that beef and poultry 

are not generally high risk, at what point, where in the chain do 

they become high risk? 

Mr. ALMANZA. Well, that is something that needs to be looked at, 

because, obviously, the federally inspected establishments or the 

regulated establishments, they do everything within their power to 

create a safe and wholesome product. Once it gets beyond them 

then they don’t have any control over what occurs, say at the market. If some of those products are used for purposes that they 

weren’t intended to be used for then it creates a higher risk. So, 

the whole risk ranking needs to look at the process, the production, 

and how the products are handled beyond their control. 

The CHAIRMAN. What about seafood, is that——

Mr. ALMANZA. We currently do not have seafood. That would be 

FDA, but I really don’t know that. 

The CHAIRMAN. Have you ever been aware of oysters being a 

high risk food? 

Mr. ALMANZA. I know what I read in the paper about them but 

that is about it, sir. 

The CHAIRMAN. It would be helpful for the Committee if we could 

get more information on how high risk products are designated at 

what point, where is it, because you have, certainly, in your testimony spoke very emphatically about high risk products. 

Mr. ALMANZA. Right. 

The CHAIRMAN. And, we certainly need to know a definition of 

that, at what point in the chain do they become high risk, what are 

they. We need to know what and where they are in the chain, and 

whether or not we should inspect them on a continuous basis, 

which I might ask you once we identify who and what they are, 

would we need to then put a more continuous inspection process 

on them? 

Mr. ALMANZA. Yes, sir. There is currently a Food Safety Working 

Group that has been comprised of us and FDA, and they are looking at those types of things. I think it would be very helpful to 

have someone do a risk ranking of all products and that way we 

would be able to determine. Today I can tell you, do we over-inspect some products? Yes, we do. Do we under-inspect some products? I don’t know the answer to that, but I can tell you that we 

have a daily presence and we are at every federally-inspected establishment every single day and every single animal that is 

slaughtered is inspected. So, I understand what you are saying and 

we can certainly get back to you with information that we have on 

that. 

14

The CHAIRMAN. That would be very helpful if we could get a 

ranking on that. And say, when you said there that someone 

should do that ranking, would that someone be USDA? 

Mr. ALMANZA. Well, that is certainly something that, perhaps, 

the Food Safety Working Group could do or have it tasked out to 

be done. 

The CHAIRMAN. All right. Thank you very much. My time has expired. We will now go to Representative Roe. 

Mr. ROE. Thank you, Mr. Chairman. First of all, the food in this 

country is safe. I want the people to understand that there are 

some problems, but I go to a restaurant and eat or out to the cafeteria and eat here at the House. It is a safe product that we have. 

And no one is any more interested in that than the producers. They 

have a tremendous vested interest, and of course we are going to 

hear from that on the next panel. You may not know the answer 

to this, but how many foodborne illness deaths are there in the 

United States per year, do you know? 

Mr. ALMANZA. No, sir, I do not know that. 

Mr. ROE. We probably could get that. I think it would give us 

some idea of how many foodborne outbreaks we are talking about. 

How big is the problem before you go at it with an atomic bomb, 

how big of a problem is it, so if we could find out that information. 

You mentioned several of the Salmonella and E. coli and so forth, 

but if we could know that, that is important. And to dovetail a little bit what the Chairman was saying is it a problem when you 

have multiple agencies inspecting food or is it clear division of 

labor? You know I am a physician and if you have this one inspecting you over here, and there are different rules each time you don’t 

know exactly how to behave as a producer. And I agree with the 

Ranking Member that there is a tremendous amount of expertise 

sitting right behind you. 

Mr. ALMANZA. Oh, absolutely, and we meet with the industry 

once a month. We have industry meetings where the industry 

comes in and we meet with them. We go over some of the current 

issues that are occurring, some of the publications, some of the notices, some of the directives that we are going to issue. Can we do 

a better job of getting their input? I agree, yes, I think we can. One 

interesting thing that I would like to say is I used to work for the 

industry before I came to work for FSIS, so I understand their role, 

and certainly when I sit—I was talking about the risk ranking, I 

didn’t mean to imply that there was some enormous risk—but in 

order to have a uniform system for inspection, I would say that 

there has to be a risk ranking on something, and you base it on 

foodborne illnesses. 

I mean there has to be a number of things that come into play. 

It is not going to be just because somebody gets ill somewhere the 

risk goes up. I mean you have to take certain things into consideration, was the product cooked properly and things of that nature. 

Mr. ROE. Sure. Back again to the question of multiple agencies, 

could you speak to that? 

Mr. ALMANZA. Well, as I said, when you look at single agencies 

or multiple agencies, that is certainly something that is going to be 

decided above my level. But I will say that priority number one is 

going to be food safety, and certainly risk in how different products 

15

are regulated and how they are inspected. In particular, I think of 

food safety as being a strong component of that when you look at 

how those three things come together. When you build a uniform 

system it doesn’t really matter whether it is one agency or multiple 

agencies, it just has to be a uniform way of doing it based on risk. 

Mr. ROE. I think where I am coming from is, and looking at the 

producers back there, I remember it is kind of amusing, but the 

government does an examination of our hospitals—well, they go 

into one of our hospitals and have us tear the whole bathroom out 

and fix it and then the state comes back and says fix it back like 

it was. And I wonder if when you have multiple agencies—that was 

a great question the Chairman asked—is that a real problem. 

Maybe you are not in a position, it sounds like, to answer that 

question, but I think that is one we ought to look at. I tried to understand, I read all of this how it is inspected and it is confusing 

at best. 

Mr. ALMANZA. Well, FSIS has a daily presence in every single establishment, and we inspect every single animal that is slaughtered. In processing facilities we have an inspector that goes to the 

facility and performs specific tasks every single day. That is our 

system of inspection. So if we look at risk, and I am talking about 

in a broad sense—and I am not talking about just meat, poultry, 

and eggs—but if you look at risk associated with products then you 

will start having a better idea of whether it is better to have a single food safety agency or multiple agencies. I won’t be able to make 

that decision. It certainly would be above my level. 

Mr. ROE. Thank you, Mr. Chairman. 

The CHAIRMAN. The gentleman from California, Mr. Costa. 

Mr. COSTA. Thank you, Mr. Chairman, for holding this important 

hearing as it relates to food safety. Obviously, American consumers 

care very much about the safety of their food that they consume. 

I want to thank Congressman Markey for deferring. I am trying to 

get back to California. I have a number of questions, so let us get 

to the quick of it here, Mr. Almanza. 

Mr. ALMANZA. Yes, sir. 

Mr. COSTA. First of all, any time you have a new Administration 

coming in and you have the transition, you have the acting assistants and so forth, and so on, and, obviously, until the new team 

gets confirmed and in place—I do want to be focused that the folks 

that are acting directors, acting assistant secretaries—so that you 

are not in a position where they are promulgating regulations without the appropriate time and input until everybody gets their feet 

on the ground. You are not doing anything like that? 

Mr. ALMANZA. No, sir. 

Mr. COSTA. And you don’t have any inclination that that is going 

to be taking place? 

Mr. ALMANZA. No, sir. 

Mr. COSTA. Food safety, obviously the key to that is risk assessment and risk management, and USDA has, generally, a very good 

track record over decades on beef and poultry. But you reference 

in your testimony food safety assessments that you conduct every 

4 years. Could you give the Committee a bit more detail of what 

goes on in a food safety assessment, who conducts the reassessVerDate 0ct 09 2002 11:26 Oct 02, 2009 Jkt 041481 PO 00000 Frm 00019 Fmt 6633 Sfmt 6601 I:\DOCS\111-10\52575.TXT AGR1 PsN: BRIAN
16

ments, what sort of training these personnel receive to ensure that 

they can perform the evaluations quickly? 

Mr. ALMANZA. Yes, sir. We have what we call EIAOs—we are full 

of acronyms at FSIS—which are Enforcement Investigation Analysis Officers, that are put through a 4 week course down in College 

Station. What they do is they are trained to analyze data and to 

look at the food safety systems within an establishment, and to be 

able to make determinations whether their risks are identified 

and——

Mr. COSTA. Assessing the risks so you can make the proper determination on the management? 

Mr. ALMANZA. Yes, sir. 

Mr. COSTA. On that point, the data obviously is important that 

you collect and that it be empirical in nature and not be influenced 

subjectively, at least from my perspective. Could you share with 

the Committee what you are doing to ensure that there is quality 

and consistency in that sense and empirical data issues? 

Mr. ALMANZA. Well, the EIAOs, they are all trained in the same 

manner. In fact, we just had a new enhanced training session for 

our EIAOs to be able to do it in a very uniform manner, whether 

it be in Virginia or whether it be clear across the country in California. We want a uniform way of food safety. 

Mr. COSTA. Absolutely. I have significant beef and dairy in my 

area in the San Joaquin Valley, and we have a number of facilities 

there that deal with both dairy beef as well as beef cattle. In that 

sense, how do you determine or ascertain that the science-based 

data is consistently collected and properly analyzed from California 

to Georgia and everywhere in between? 

Mr. ALMANZA. Through the training that those EIAOs get, Congressman, what we have done is we have all of them put through 

the same 4 week training class, and then we have also just finished 

the ninth class of updating them in the enhanced methods of food 

safety assessments. 

Mr. COSTA. Okay. I don’t have much time left. I want to go quickly. Obviously, as we look, and I have legislation on food safety 

things and part of it is patterned after what we have done with the 

USDA on fresh foods and vegetables, but one of the things is that 

we have a uniform nationwide goal standard and that that goal 

standard be also applied to food that is imported from other parts 

of the world. Under your agency the equivalency requirements with 

foreign governments, and not individual companies seeking to export product to the U.S., do you believe the system is effective? 

Mr. ALAMANZA. Yes, I do. 

Mr. COSTA. Why do you think you prefer this instead of company 

specific equivalency? 

Mr. ALAMANZA. Why do I believe——

Mr. COSTA. As opposed to—I mean my understanding is you prefer this to a company specific equivalency. 

Mr. ALAMANZA. Oh, okay. Because when you deal government to 

government, actually what you have done is the government takes 

from the foreign government, takes a responsibility in assuring 

that the products that they are going to be certifying to be shipped 

to the United States are equivalent to what we require in the 

United States. 

17

Mr. COSTA. All right. My time has expired, but I want to thank 

Congresswoman Markey for deferring, and I want to thank the 

Chairman for holding this important hearing. I have a number of 

other questions that I will submit not only for this gentleman but 

also for the second panel, and keep on continuing doing the good 

work you are doing. 

The CHAIRMAN. Thank you very much, Mr. Costa. We will now 

hear from the gentlewoman from Colorado, Ms. Markey. 

Ms. MARKEY. Yes. Thank you, Mr. Chairman, for holding this 

hearing, and I also want to echo Congressman Roe’s statement that 

we do have a safe food supply, generally, in this country. We can 

always work on doing better. But I want to talk a little bit as well 

about imported food, because there is, of course, a lot of concern 

about products that are imported from other countries. Do you feel 

that the risk is greater for imported foods as opposed to inspecting 

foods grown or processed in this country, and what also do you feel 

are—you mentioned some of the steps that are taken to ensure 

safety of imported products, but do you feel that there are any 

weaknesses at all? For instance, do you feel like you have enough 

resources, staff to adequately inspect foods that are imported from 

other countries? 

Mr. ALMANZA. Okay. Your first question, do I believe that there 

is a higher risk? I don’t necessarily believe, for the products that 

we regulate, that there is a higher risk because of the type of inspection that we provide for those products. We do 100 percent reinspection of products that are imported that are meat, poultry, 

and processed eggs, so when we have that system, and we are continuously monitoring the system at the different ports, I feel confident that we minimize that risk. As far as your second question, 

can we do better? Certainly, I think we can do better. I think that 

we currently have adequate staff for the products that we are receiving. I know that as other countries are asking to be eligible to 

export to the United States and perhaps there would be an increase then we may need some additional inspection personnel, but 

at the time I think we are perfectly fine. 

Ms. MARKEY. Let me just follow up with another question. You 

talked a little bit about recalls, but can you explain how FSIS handles a recall, what are the steps? 

Mr. ALMANZA. Well, when we have an occurrence what we do is 

we form a recall committee from within the agency, different parts 

of the agency, to look at different parts of what was the risk or 

what occurred that is going to be necessitating a recall. Is it an allergen, is it an adulterant, those things are weighed before the 

agency decides to contact the establishment or the producer to decide whether there will be a recall or not. 

Ms. MARKEY. Thank you, Mr. Chairman. 

The CHAIRMAN. Thank you. Ranking Member Neugebauer. 

Mr. NEUGEBAUER. Let me ask you just a couple of questions, Mr. 

Almanza. What is the status of HACCP with eggs? 

Mr. ALMANZA. We are trying to move that forward but I can submit for the record some information on that. I don’t know exactly 

where we stand on it right now. 

Mr. NEUGEBAUER. But you will submit that for the record to the 

Committee? 

18

Mr. ALMANZA. Yes, sir. 

Mr. NEUGEBAUER. Thank you so much. In your testimony, excuse 

me, you discussed the importance of looking at risk earlier, as we 

discussed, and the need to ask questions about the level of inspection that is necessary for different foods. As FSIS works through 

this process, do you see a need to change any of FSIS’ underlying 

statutes so that the agency can effectuate the changes it determines are necessary? 

Mr. ALMANZA. I think it is a little bit early in the process to 

make that determination. As I said earlier, if there is a risk ranking for all products, I think once we have a good gauge on that, 

then we would be able to answer that adequately. 

Mr. NEUGEBAUER. As you discussed, for FSIS to establish meaningful performance objectives, the agency needs accurate data attributing illnesses to specific foods. What needs to happen research, 

funding or otherwise, for this to be accomplished? What agency 

should be responsible for making this happen? 

Mr. ALMANZA. One of the things that we are currently working 

on is our new Public Health Information System and when we put 

that in place, we are going to move from a passive system, PBIS, 

to a more real time system which is in my opinion one of the most 

exciting things to come along. Being a former inspector and being 

able to look at the data that is generated in the field because there 

are different facets to this system, for example, there will be a facet 

that provides what we call Predictive Analytics. There will be facets to it where we will be able to see trends within an establishment within a part of the country, and then also as a nation if 

something is going wrong we will be able to detect those, hopefully, 

before any outbreaks. It is just a system that I believe is going to 

move us way into the—it would be kind of like riding a horse to 

driving a car in my opinion. 

Mr. NEUGEBAUER. And the agency to make this happen would be 

the USDA? 

Mr. ALMANZA. Yes, sir. 

Mr. NEUGEBAUER. As you mentioned, one of FSIS’ goals is to conduct food safety assessments in each plant at least every 4 years. 

Are you on a pace to meet that goal and what is FSIS learning by 

carrying out these assessments? 

Mr. ALMANZA. Yes, we are on pace to accomplishing a food safety 

assessment every 4 years, and what are we learning? We are getting a lot of good information from within the establishments, what 

is occurring within establishments both good and what is wrong. I 

think that it is a good tool for the agency to be able to have data 

on every federally-inspected establishment. 

The CHAIRMAN. Okay. Thank you very much. The gentleman 

from Texas, Mr. Conaway, would you have any questions at this 

time? 

Mr. CONAWAY. Just a bit of a follow-up there. As you are doing 

these assessments on each of these plants and you come across 

things that are not working and things that are violations or whatever, do you have some sort of a communication tool to broadcast 

throughout the system of regulated plants to say, these are things 

we are seeing going on, make sure you are not doing them at your 

19

plant, that would take advantage of whatever information you are 

gaining when you do these reviews? 

Mr. ALMANZA. If we see a trend in that, we certainly communicate that to the industry in meetings that we have with the industry on a monthly basis. 

Mr. CONAWAY. When you say industry, do you mean industry 

representatives or everybody—how many plants are there? 

Mr. ALMANZA. About 6,200. 

Mr. CONAWAY. So you wouldn’t have all 6,200 plants represented 

at each meeting? 

Mr. ALMANZA. No, sir, but we have industry representatives that 

we meet with. 

Mr. CONAWAY. Any thoughts of having some sort of an e-mail 

blast system where all 6,200 would have e-mail addresses that you 

would have that you could send that information going out directly 

to them rather than through representatives? 

Mr. ALMANZA. We have an outreach office that communicates directly with our small and very small producers, and if we were to 

see something like that certainly that would be within the realm 

of possibility, yes, sir. 

Mr. CONAWAY. To set that up or that you have already got one 

in place that you could use? 

Mr. ALMANZA. We have one in place that we can use. 

Mr. CONAWAY. So you have e-mail addresses on all 6,200? 

Mr. ALMANZA. I don’t know that every 6,200, but I would say the 

vast majority. 

Mr. CONAWAY. Okay. Have you had occasion to come across immediate information, some immediate concern across the system, 

where you had broadcast it? 

Mr. ALMANZA. Not that I know of. 

Mr. CONAWAY. Okay. Thank you, Mr. Chairman. 

The CHAIRMAN. Thank you. How do you feel, Mr. Almanza, how 

do you feel about third party audits? Is there an appropriate role 

for third party audits by the industry? 

Mr. ALMANZA. I think certainly that is a useful tool. I don’t think 

that it is a substitute for Federal oversight or Federal inspection, 

but it is a useful tool. 

The CHAIRMAN. All right. Let me just ask you one more interesting question. What about imports? We import some of our food 

products, and there has been a lot of concern about products from 

other countries. How does FSIS ensure the safety of imported food 

products? 

Mr. ALMANZA. Okay. When products are imported into the 

United States, we have inspectors that are at each of the ports. 

First, there is a database that they access to make sure that the 

country that the product is coming from is an approved country. 

Second, they have to check and make sure that the product, the 

specific product, that is coming in is one of the products that that 

country is eligible to export to the United States. Then, third, they 

do an inspection of the load before it enters into the country. 

The CHAIRMAN. Thank you. Just one final question I have. The 

President has put together a Food Safety Working Group. How do 

you assess its performance so far? 

20

Mr. ALMANZA. It is early. They have had a couple of meetings. 

I have been able to sit down in a couple of them. I think it is very 

progressive. It is something that will move the mark, and it certainly should gain some support because it is something that will 

help us get to where we need to get to. 

The CHAIRMAN. How would you—you are in a unique position 

here. It might be good to end this on a grading system. How would 

you grade our food safety program in this country, A, B, C, D? 

Mr. ALMANZA. I could only speak for meat, poultry, and egg products, and I would give it an A+ as far as safety, the safety of the 

products. Like I said, I used to work for the industry and certainly 

working for FSIS, it will be 31 years May 5, and I have seen a lot, 

but our meat, poultry, and egg products that we regulate, I think 

an A+. 

The CHAIRMAN. On that very positive note, we will end your 

presentation, and thank you very much. We will now have the second panel to come forward. 

Mr. ALMANZA. Thank you. 

The CHAIRMAN. I certainly want to thank you, our second panel, 

and welcome you to our Committee. Let me very briefly introduce 

our second panel, a very distinguished panel, I might add. First, we 

have Mr. J. Patrick Boyle, President and CEO of the American 

Meat Institute here in Washington, D.C. Thank you for coming. Dr. 

James ‘‘Bo’’ Reagan, Senior Vice President, Research, Education 

and Innovation, National Cattlemen’s Beef Association here in 

Washington. Ms. Jill Appell, pork producer, Appell’s Pork Farms, 

Inc., Past President of the National Pork Producers Council, 

Altona, Illinois. Dr. Elizabeth Krushinskie, Director of Quality Assurance and Food Safety, Mountaire Farms, Inc., on behalf of the 

National Chicken Council, Millsboro, Delaware. Dr. Michael Rybolt, 

Director, Scientific and Regulatory Affairs, National Turkey Federation in Washington. Mr. Elliot P. Gibber, President, Deb-El 

Foods, on behalf of United Egg Association’s Further Processors Division, Elizabeth, New Jersey. And Mr. Barry L. Carpenter, Chief 

Executive Officer, National Meat Association, Oakland, California. 

Welcome to all of you. Thank you very much. We will begin with 

you, Mr. Boyle. 

STATEMENT OF J. PATRICK BOYLE, PRESIDENT AND CEO, 

AMERICAN MEAT INSTITUTE, WASHINGTON, D.C. 

Mr. BOYLE. Thank you very much, Mr. Chairman, Members of 

the Committee. AMI appreciates the opportunity to provide perspective and, hopefully, some insight into our nation’s food safety 

inspection system for meat and poultry products. Food safety is the 

Institute’s number one priority and for the past 10 years has been 

addressed by AMI members in a non-competitive manner by sharing best practices and new technologies amongst themselves to improve food safety for the good of the industry and of our customers. 

Today, I would like to highlight some of the significant food safety 

improvements in meat and poultry products and the important role 

USDA plays in overseeing them. The Committee will note that I 

have a PowerPoint presentation to accompany my remarks and a 

technical expert on my right. 

21

First, the meat and poultry industry supports a strong Federal 

inspection system, and we have a very strong system. Eight thousand employees of FSIS inspect approximately 6,200 domestic meat 

and poultry operations, and an additional 2,000 Federal employees 

with FSIS provide supervision and support services at a total cost 

of more than $1 billion a year. Plants processing animals are inspected during all hours a plant is operating. Plants processing 

meat and poultry products are inspected at least on a daily basis. 

For imported meat and poultry products Federal law requires the 

foreign countries inspection system to be the equivalent of our U.S. 

meat and poultry inspection system. Thirty-three foreign countries 

are currently approved to ship products to the U.S. and each foreign inspection system is audited annually. 

All meat and poultry products arriving at our borders also are 

subject to re-inspection and laboratory analysis. Seventy-five import inspectors conduct these activities at 150 official import establishments. More than a decade ago, FSIS and the industry embraced a major shift in the approach to food safety programs by 

adopting the principles of prevention embodied in HACCP. In fact, 

in 1993, it was the American Meat Institute that formally petitioned USDA for such a mandate. FSIS oversight does not stop 

with HACCP regulations. FSIS assures processes are scientifically 

validated. Teams of expert auditors conduct periodic in-depth food 

safety reviews, which can take days or weeks to complete and may 

involve extensive microbiological sampling of a plant’s environment 

and its finished products. 

Annually, FSIS conducts more than 80,000 microbiological tests 

to verify the production processes are under control. These tests 

are in addition to the several million microbiological tests the industry does each year. In addition to process control programs, the 

plan is required to have written standard sanitization operating 

procedures that prescribe how the operating environment will be 

maintained in a sanitary condition. We clearly have a strong intensive Federal meat and poultry inspection system, but it is important to recognize only the industry can produce safe food, and we 

have been making noteworthy progress. 

Since 2000, the industry has reduced the prevalence of E. coli 

O157:H7 in ground beef by 45 percent to less than 1⁄2 percent. The 

prevalence of Listeria monocytogenes in ready-to-eat meat and poultry products has been reduced by 74 percent to less than 4⁄10 of 1 

percent. We have seen similar improvement in the incidents of 

foodborne illness reported by the CDC. Since 2000, illnesses caused 

by E. coli O157:H7 are down by 40 percent and listeriosis is down 

by ten percent with much of the improvement actually occurring 

before 2000, the years that were not captured in this graph. And 

we have not had a single product recall associated with an outbreak of listeriosis over the past 6 years. 

As Congress considers various bills to reform FDA oversight a 

variety of additional regulatory authorities are being proposed, I 

would like to address three of them. First, microbiological performance standards. AMI believes that they can be a useful tool, if 

properly constructed, to achieve a public health objective and are 

scientifically based to measure food safety. Our experience with 

FSIS performance standards show us that some of them have 

22

worked and some of them have not. Second, civil money penalties: 

AMI believes very severe penalties are already in place for meat 

and poultry plants. For example, FSIS can detain and seize adulterated products in commerce, as well as retain product at the 

plant, thereby preventing it from entering commerce. 

Federal inspectors also have the authority to shut down a plant 

at a moment’s notice if food safety violations are identified. More 

serious violations can result in Federal inspectors being withdrawn 

from the plant and the resulting closure of the business, and plant 

management can be criminally prosecuted for food safety violations. It is difficult to comprehend how additional civil money penalties would improve meat and poultry safety. And, finally, Mr. 

Chairman, mandatory recall authority: AMI believes such authority 

is needlessly redundant. Industry has every incentive to remove 

contaminated product from the marketplace to reduce potential liability, and the detention and seizure authority of FSIS provides 

the agency with more than sufficient leverage to compel a so-called 

voluntary recall. In short, the concept of mandatory recall is a solution in search of a problem. Thank you very much for the opportunity to appear today, and I look forward to answering any of your 

questions. 

[The prepared statement of Mr. Boyle follows:]

PREPARED STATEMENT OF J. PATRICK BOYLE, PRESIDENT AND CEO, AMERICAN MEAT

INSTITUTE, WASHINGTON, D.C. 

Good afternoon, Mr. Chairman, Ranking Member, and Members of the Subcommittee. Thank you for allowing me the opportunity to appear before this Subcommittee. My name is Patrick Boyle and I am the President and CEO of the American Meat Institute (AMI). AMI has provided service to the nation’s meat and poultry industry—an industry that employs more than 500,000 individuals and contributes more than $100 billion in sales to the nation’s economy—for more than 100 

years. 

AMI’s 200 members include the nation’s most well-known meat and poultry food 

manufacturers. Collectively, they produce 90 percent of the beef, pork, veal and 

lamb food products and 75 percent of the turkey food products in the U.S. AMI’s 

membership is extremely diverse, ranging from large, publicly traded companies 

that employ thousands to very small companies with as few as two employees. Indeed, more than half of AMI’s members are small, family-owned businesses employing fewer than 100 individuals. We have one member company with just three employees. These companies operate, compete, sometimes struggle, and mostly thrive 

in one of the toughest, most competitive and certainly the most scrutinized sectors 

of our economy: meat and poultry packing and processing. 

AMI appreciates the opportunity to provide perspective and hopefully insight into 

our nation’s food safety inspection system for meat and poultry products. Food safety is the Institute’s number one priority. Each year, the AMI Board of Directors establishes priorities to direct the Institute. Food safety has topped the list for the 

past decade. In 1999, food safety was made a non-competitive issue by the organization which provided top management commitment to share best practices and new 

technology to improve food safety for the good of the industry. 

We all know that food safety has been in the news and because of that publicity 

a common refrain heard in Washington and other venues is that the U.S. food safety 

regulatory system is broken and has failed the American people. Indeed, a great 

deal of attention has been devoted to what is wrong and the changes needed to assure us that the food we consume is safe. Although some of the criticism may be 

warranted, a closer look at our meat and poultry food safety systems yields a different conclusion. 

lllnesses associated with meat and poultry consumption have declined. Nearly one 

billion meals are consumed each day in the United States without incident (slide 

1). For context, human illness statistics published by the Centers for Disease Control and Prevention show that the pathogens most commonly associated with meat 

and poultry make up only a fraction of the total foodborne illnesses and deaths in 

23

the U.S. (slide 2). These statistics are not provided to minimize each and every illness, hospitalization, or death associated with food consumption, but to put the risk 

into proper context. 

Is the sky falling—no, but most rational individuals still believe that food safety 

can be improved. I would like to discuss with you today some of the real improvements the meat and poultry industry has made and the important role government 

oversight plays in assuring that the industry meets its responsibility to produce safe 

food. 

First, the meat and poultry industry supports a strong Federal oversight system—

and we have a strong system. The approximately 8,000 employees of USDA’s Food 

Safety and Inspection Service (FSIS) inspect approximately 6,300 domestic meat 

and poultry operations and an additional 2,000 Federal employees provide supervision and support services, at a total cost of more than $1 billion. Plants processing 

animals are inspected during all hours the plant is operating. Plants preparing meat 

and poultry products are inspected at least daily. (Slide 3). 

For imported meat and poultry products, Federal law requires the foreign country’s inspection system to be equivalent to the U.S. system. Thirty-three foreign 

counties are currently approved to ship products to the U.S. and each foreign inspection system is audited annually. All meat and poultry products arriving at our borders also are subject to reinspection and are routinely inspected and sampled for 

laboratory analysis. Seventy-five import inspectors conduct these activities at 150 

official import establishments. (Slide 4). 

Another comment often heard is that the food safety system must be preventative. 

We agree. More than a decade ago FSIS and the industry embraced a major shift 

in the approach to food safety programs by adopting the principles of prevention embodied in the Hazard Analysis and Critical Control Point, or HACCP. In fact, in 

1993 AMI petitioned USDA to mandate the implementation of HACCP in federally 

inspected plants in an effort to modernize the meat and poultry food safety inspection system. (Slide 5). 

Mandatory HACCP provides a framework for identifying potential hazards and 

implementing measures to control those potential hazards during the production 

process. The process is continually monitored to assure that critical food safety 

standards are met. Pre-planned corrective actions are prescribed if critical limits are 

not met. Records are kept and available to FSIS inspectors for review and procedures are established to verify that the system is working properly. 

FSIS oversight does not stop there. FSIS assures processes are scientifically validated. Teams of expert auditors conduct periodic in-depth food safety reviews to 

complement the activities performed by the FSIS inspectors permanently stationed 

at the plant. These food safety assessments, or FSAs, can take days or weeks to 

complete and may involve extensive microbiological sampling of the environment 

and product. (Slide 6). 

During the course of a year, FSIS conducts more than 80,000 microbiological tests 

to verify that federally inspected establishments’ production processes are under 

control. FSIS conducts these verification tests in addition to the several million 

microbiological tests the industry does each year. (Slide 7). 

There is no finished product testing regime, however, that can guarantee that food 

products are pathogen-free or that they can be mishandled and remain safe to eat. 

Finished product testing is an important tool because it can show that process controls are effective and working, but it cannot eliminate every risk to a meaningful 

degree of certainty. 

In addition to process control programs, the plant is required to have written 

standard sanitation operating procedures that prescribe how the operating environment will be maintained in a sanitary condition. FSIS monitors plant sanitation before operations begin and while the plant is operating. Any deficiencies noted require immediate corrective action and failure to react appropriately can result in the 

plant being shut down by FSIS officials until the deficiencies are corrected. (Slide 

8). 

We have a strong Federal meat and poultry inspection system, but it is important 

to recognize only the industry can produce safe food. Although food processors and 

handlers can minimize risks through the use of systems discussed above and other 

good management practices, there can be no absolute certainty that all food products are free from all risks. Notwithstanding that caveat, progress has been and is 

being made. 

Specifically, government data show a decline in pathogen prevalence on meat and 

poultry products. Since 2000, the industry has reduced the prevalence of E. coli 

O157:H7 in ground beef by 45 percent to less than 1⁄2 percent. (Slide 9). The prevalence of Listeria monocytogenes in ready-to-eat products has been reduced by 74 percent to less than 0.4 percent. (Slide 10). We have seen similar improvement in the 

24

incidence of foodborne illness reported by the Centers for Disease Control and Prevention. In that regard, since 2000, illnesses caused by E. coli O157:H7 are down 

by 40 percent and listeriosis is down by ten percent with much of the improvement 

occurring before 2000. (Slides 11–12). 

A question often debated is whether microbiological performance standards are 

needed to improve public health. To answer that question, it is instructive to look 

at the existing Salmonella performance standards that are codified in the meat and 

poultry regulations. 

Since the performance standards were promulgated, the prevalence of Salmonella

in chicken is down by 58 percent, in pork it is down by 68 percent, and in ground 

beef it is down by 64 percent. (Slides 13–15). Looking at these numbers one might 

conclude the Salmonella performance standards are a great success. Of significance, 

however, is the fact that the incidence of foodborne illness associated with Salmonella has actually increased slightly over the same time period. (Slide 16). 

One might ask whether microbiological performance standards are a useful tool? 

The answer is they can be if properly constructed to achieve a public health objective and if they are scientifically based to measure whether food is safe and not injurious to public health. Conversely, I would suggest that a performance standard 

based solely on achieving an arbitrary outcome that yields no public health benefit 

is inappropriate. 

As the food safety debate heats up, some Congressional Members and others have 

called for enhancing the enforcement powers of the inspection agencies, including 

civil monetary penalties and other sanctions. For meat and poultry plants, however, 

very severe penalties already are in place. 

Specifically, FSIS can detain and seize adulterated products in commerce, as well 

as retain product at the plant thereby preventing it from entering commerce. Federal inspectors also have the authority to shut down a plant at a moment’s notice 

if food safety violations such as insanitary conditions are identified. More serious 

violations can result in Federal inspectors being withdrawn from the plant, which 

results in the plant not being able to operate. And, plant management can be criminally prosecuted for food safety violations. It is difficult to comprehend how additional remedial penalties would improve food safety. 

Another subject of some controversy is mandatory recall. The cry for mandatory 

recall ignores a simple fact: Industry has every incentive to remove contaminated 

product from the marketplace to reduce potential liability. Experience shows us that 

the speed with which contaminated meat and poultry product is removed from the 

market will not improve with mandatory recall. In most cases, meat and poultry 

products are recalled within hours after a problem is discovered. And industry cooperation to execute recalls has been excellent. (Slide 17). 

To date, no meat company has ever refused to conduct a warranted recall and in 

the highly unlikely event such a circumstance ever were to occur, the previously 

mentioned threat of FSIS product detention and seizure, coupled with the agency’s 

ability to directly inform the public not to consume the product because the company refused to recall the affected product, not to mention the ramifications for the 

company at the producing plant, is more than sufficient leverage for FSIS. To my 

knowledge, such a situation has never occurred. In short, the concept of mandatory 

recall is a solution in search of a problem. 

Let me conclude with some suggestions on what will improve food safety.

(1) With respect to government inspection programs the focus must be on systems designed and implemented to protect public health. Inspection activities 

that do not have a direct impact on public health waste scarce resources and 

divert attention from issues of public health importance.

(2) Continual improvement of preventive process control systems is needed. 

Mandatory HACCP and SSOP that focus on prevention versus detection is critical and the rigor of the control system should be proportional to the public 

health risk.

(3) Government agencies must be fully funded to help assure the safety of domestically produced and imported food.

(4) Resources should be allocated based on the public health risk posed by a 

particular food and the control measures that are used during the manufacturing and distribution process to control such risk.

(5) Objective and achievable food safety standards that are scientifically determined to measure whether the food is safe, not adulterated, and non-injurious 

to public health are needed. Food safety standards must be based on quantifiable, measurable criteria and have a direct impact on public health.

25

(6) The U.S. must assure that such standards are compatible with internationally recognized standards, such as Codex Alimentarius, to protect the health of 

consumers, ensure fair trade practices, and promote the coordination of food 

standards development by the international community.

(7) Efforts should be focused on conducting a more thorough analysis to identify 

how and why a foodborne disease outbreak occurred. Each government agency 

involved in investigations of foodborne disease outbreaks or product recalls 

should be required to report the reasons such incidents occurred and those reports should focus on how the food product was harvested, processed, distributed, prepared, and consumed to provide detailed information that will assist 

food handlers in preventing future occurrences.

(8) Rigorous government inspection and testing is needed to verify that consumer-ready products are safe. Test results should be performed under accepted 

sampling and analytical protocols and should meet objective food safety standards. Testing to determine the adequacy of process control at interim points 

during harvesting, manufacturing, and distribution should be conducted by the 

industry.

(9) Establishment of a public-private partnership to design and implement a 

comprehensive research program to improve food safety is needed. The research 

program should be directed by a board of qualified food safety experts from government, academia, and industry. The program should focus on developing risk 

mitigation and intervention strategies to prevent foodborne disease outbreaks.

Let me provide some parting thoughts. It is indisputable that producing safe food 

is good for customers and good for business. To that end, the meat and poultry industry has been working to meet the challenge of continuously improving the safety 

of the products produced, but the job is not done. Industry pledges to cooperate with 

all parties to ensure that the U.S. maintains the safest meat and poultry supply in 

the world. 

Thank you for the opportunity to testify before the Subcommittee today. I am 

happy to answer any questions that Members may have regarding my testimony 

and the food safety system for meat and poultry products.

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The CHAIRMAN. Thank you very much. Dr. Reagan. 

STATEMENT OF JAMES O. ‘‘BO’’ REAGAN, PH.D., SENIOR VICE 

PRESIDENT—RESEARCH, EDUCATION AND INNOVATION,

NATIONAL CATTLEMEN’S BEEF ASSOCIATION; CHAIRMAN, 

BEEF INDUSTRY FOOD SAFETY COUNCIL, WASHINGTON, D.C. 

Dr. REAGAN. Chairman Scott, Ranking Member Neugebauer, and 

Members of the Committee, I am Bo Reagan and I serve as Senior 

Vice President of Research, Education and Innovation for the National Cattlemen’s Beef Association. I also have the privilege of 

serving as the Chairman of the Beef Industry Food Safety Council, 

which is also referred to as BIFSCo. I am also a member of NCBA. 

I appreciate the opportunity to testify today with regard to the beef 

industry’s role in producing the most affordable, nutritious and 

safest food supply in the world. 

I would like to start out by emphasizing that everyone plays an 

important role in the safety of food. All beef is subject to strict government oversight, and everyone who plays a role in the production 

chain is committed to producing safe beef and beef products. Every 

meat processing facility undergoes daily, ongoing USDA inspections. FSIS inspectors are in the meat processing plants daily performing their inspection duties, as well as reviewing the HACCP 

plans. HACCP, as you well know, stands for Hazard Analysis Critical Control Points, but it is important for you to note that these 

plans were proactively developed by the food industry as a method 

to identify potential hazards, and then to identify methods of preventing them. 

In 1996, FSIS enacted a rule requiring HACCP plans for all beef 

processing facilities. This program has been very successful as it focuses on the process controls rather than testing as a means to protect human health. You cannot test your way to safety so you must 

focus on the processes and the controls that are in place to reduce 

potential hazards. On the research promotion and education side of 

the beef industry in my role at NCBA, I had the privilege to oversee our beef safety research, consumer education, as well as development of new beef products. Throughout the years, our beef industry and USDA have created partnerships in the beef safety research. This collaboration effort is vital as USDA and the industry 

are able to leverage our dollars and utilize the science expertise of 

not only the folks in NCBA, but also in USDA’s Agricultural Research Service to ensure that safety challenges and knowledge gaps 

are being properly addressed. 

It is imperative that USDA continues and increases ARS funding 

for food safety research. In order to achieve the goal of food safety, 

we have to understand the science of pathogens and the interventions that may be used to control them or their environment. As 

the food safety policy discussions continue, we encourage Congress 

to work with FSIS to focus on the resources needed to effectively 

implement the science and risk-based regulations that are currently in place. But, just as important is the need for employee 

training and communication of any new regulatory changes so that 

there is not any confusion or misinterpretation of the law. 

We realize that communicating regulatory changes to personnel 

throughout the country is a challenge, but this area is a concern 

36

for the beef industry. With regards to small and very small operations, there is a greater need of information and resources from 

USDA to be provided for these businesses. We encourage USDA to 

continue and increase their outreach efforts to these small businesses. Last, but not least, consumers will always play an important role to ensure the safety of their food. The beef industry has 

created numerous resources such as the safeandsavory160.com for 

consumers where they can go and learn more about the proper 

storage, handling, and cooking of beef and beef products. 

Any assistance that the Federal Government can provide to ensure the consumers learn more about their important role in food 

safety and the education resources that are available, that would 

be very appreciated. Since 1993 our cow producers have invested 

more than $27 million of their own funds in beef safety research, 

and the beef industry as a whole invests more than $350 million 

each year in ensuring the safety of beef and beef products. Above 

all, safety is a non-competitive issue for our industry and the industry has committed a broad coordinated effort to solve pathogen 

issues by developing industry wide science and risk-based strategies to address safety challenges. 

Many thanks for the opportunity to be with you today, and I look 

forward to having the opportunity to answering questions that you 

might have. 

[The prepared statement of Dr. Reagan follows:]

PREPARED STATEMENT OF JAMES O. ‘‘BO’’ REAGAN, PH.D., SENIOR VICE PRESIDENT— RESEARCH, EDUCATION AND INNOVATION, NATIONAL CATTLEMEN’S BEEF

ASSOCIATION; CHAIRMAN, BEEF INDUSTRY FOOD SAFETY COUNCIL, WASHINGTON, D.C. 

Chairman Scott, Ranking Member Neugebauer, and Members of the Committee, 

my name is Bo Reagan and I am the Senior Vice President of Research, Education 

and Innovation for the National Cattlemen’s Beef Association (NCBA) which oversees beef safety research, consumer education and the development of new beef 

products. I’m the Chairman of the Beef Industry Food Safety Council (BIFSCo), and 

also a member of NCBA. I appreciate the opportunity to testify today about the beef 

industry’s role in producing the most affordable, nutritious and safest food supply 

in the world. 

As you know, The Beef Checkoff assesses a $1 per head fee for every beef animal 

sold. The Checkoff is managed by USDA and the Cattlemen’s Beef Board (CBB). 

NCBA is the largest contractor of The Beef Checkoff and manages education, promotion and research priorities relating to beef and beef products funded by the 

Checkoff. In addition to NCBA’s Checkoff activities, we also have a policy division 

in Washington, D.C. that is not funded by The Beef Checkoff. The policy office 

works closely with NCBA members to represent their views in the legislative and 

regulatory bodies of our government. 

I would like to take a few minutes to share some of the background about the 

beef industry’s commitment to beef safety. The beef industry focus research on a variety of pathogens and two pathogens of particular interest to the beef industry are 

Salmonella and E. coli which are commonly found in the gastrointestinal tracts of 

humans and animals. Most strains do not cause illness, however, in 1993 E. coli 

O157:H7 became a research priority after an illness outbreak in the Pacific Northwest was linked to ground beef. 

In light of the outbreak, the research focus was placed on where the most impact 

could be accomplished and the research investment was made at the processing 

plant level—post harvest. At that time approximately 800,000 head of cattle were 

processed at about 35 processing facilities. The research resulted in multiple interventions being developed by industry, accepted by the government and implemented 

in the beef industry over a 10 year period. 

In 1996, USDA’s Food Safety and Inspection Service enacted a rule requiring 

HACCP (Hazard Analysis Critical Control Point) plans for all beef processing plants. 

It is important to note that HACCP plans were pro-actively developed by the food 

37

industry as a method to identify the potential hazards and then prevent them. The 

following year BIFSCo was formed to coordinate a broad effort to solve pathogen 

issues, focus on research and consumer education. Representatives from all segments of the beef industry belong to BIFSCo and work together under the founding 

principles that safety is a non-competitive issue to develop industry-wide, sciencebased strategies to address safety challenges, particularly E. coli O157:H7.

In the late 1990s, the live animal or pre-harvest area became the focus of research 

in an effort to collect data about the ecology of E. coli O157:H7. We needed to know 

more about the relationship between the pathogen and the live animal to develop 

interventions that could be used pre-harvest and to continue improving post-harvest 

interventions and their efficacy. By developing this knowledge, technologies were 

discovered that could affect the shedding and prevalence of E. coli in live animals. 

Projects funded by The Beef Checkoff serves an important role in testing the effectiveness of new technologies including vaccines, sodium chlorate, direct fed 

microbials and neomycin, all of which reduce the prevalence of pathogens in live 

animals. 

The current research program focuses on building the knowledge base of E. coli 

O157:H7 and Salmonella by identifying the where, why and how it survives from 

pre- to post-harvest. We are also taking into consideration the impact of production 

practices, processing systems and interventions and the possible development of resistance between the pathogens and interventions. NCBA continues to evaluate how 

to optimize food safety systems not only for the current safety challenges but also 

for any potential future challenges. 

It is important to note that everyone plays an important role in the safety of 

food. All beef is subject to strict government oversight and everyone who plays a 

role in the production chain is committed to producing safe beef products. Every 

meat processing facility undergoes on-going USDA inspection, which includes review 

of their HACCP plans. Consumers also play an important role in food safety and 

should always follow the food handling, cooking and storage steps that are essential 

in preventing foodborne illness. 

America’s beef producers and our partners will continue to dedicate significant 

time and resources to reduce the incidence of pathogens. Cattle producers’ top priority is to produce the safest and highest quality beef in the world. This has been 

consistent throughout our industry’s history and in our long-term efforts to continually improve our knowledge and ability to raise healthy cattle. To date, cattle producers have invested more than $27 million since 1993 in beef safety research, and 

the industry as a whole spends approximately $350 million every year on beef safety. Above all, safety is a non-competitive issue for the beef industry. 

Our producers believe that it is the responsibility of our government to give the 

industry the various tools needed to keep our food safe and reduce pathogens including E. coli O157:H7 in beef products. Interventions, both pre- and post-harvest are 

vital parts of a system of hurdles in beef production and processing. There is not 

a ‘‘silver-bullet’’ for a common intervention application and because of the multi-hurdle approach it is not necessary that there be one. 

Beef packing plants and processers vary in size as well as in design, and nearly 

100 percent of beef establishments use one or more of the safety interventions the 

beef industry has helped research, implement and validate. These interventions 

have been accepted by USDA and include hide washes, hand-held steam vacuums, 

spray washes, organic acid sprays and irradiation. In addition to the use of interventions, NCBA also believes that processing establishments should make an ardent 

effort to minimize the threat of foodborne illness and increase pathogen control 

through continual process improvements. 

It is essential that all safety programs be based on science, have a strong research 

foundation, focus on industry application and be communicated to the appropriate 

sector to implement. NCBA has worked diligently to find pre- and post-harvest 

interventions to decrease as much as possible, the potential load of bacterial pathogens in beef products. Currently, there are a variety of processing aids the industry 

may use to eliminate E. coli O157:H7 but microbial contamination continues to be 

an obstacle to overcome and the cattle industry remains committed to further reducing and eliminating the presence of E. coli O157:H7 in beef products. 

In terms of food safety, there is still work that needs to be done to accomplish 

the public health goals established for 2010. These goals include reducing the national incidence of Salmonella, E. coli O157:H7, Campylobacter and Listeria to 50% 

38

1 Healthy people 2010 objectives: draft for public comment. Office of Public Health and 

Science. Washington: U.S. Department of Health and Human Services, September 15, 1998. 

of their 1997 incidence.1 In order to meet and exceed the 2010 goals proven sciencebased technologies will need to be utilized. As well, NCBA consistently strives to 

work with all of our partners to research new science-based technologies and interventions that will continually contribute to the safety and quality of our products. 

With the current budget and economic situation facing our country, there has 

never been a more important time for our government and the beef industry to work 

together to achieve the common goal of beef safety. Throughout the years, there 

have been several opportunities for the beef industry and USDA to create a partnership on beef safety research. This collaborative effort is vital as USDA and the industry are able to leverage dollars and utilize the scientific expertise of USDA’s Agricultural Research Service’s (ARS) scientists to ensure safety challenges and knowledge gaps are being addressed proactively. Every year, the Checkoff funds and 

NCBA manages several ARS food safety research projects. Some of the projects have 

included the prevalence monitoring of pathogens from gate to plate, pre- and postharvest intervention development, methodology improvements in accuracy and basic 

research on the genetics of pathogens. It is essential for the industry to utilize 

USDA personnel at meetings and workshops to ensure that we are working towards 

the same goal. It is common for the beef industry to invite USDA personnel to provide feedback when we are developing safety initiatives and programs to make sure 

that we are on target. For example, BIFSCo hosts an annual safety summit, E. coli

workshops, and ‘‘think tank’’ meetings to address safety challenges, where USDA 

personnel are invited and often attend. 

NCBA and BIFSCo will continue to proactively develop educational programs to 

disseminate food safety information from USDA to the beef industry and consumers. 

BIFSCo noticed a lack of training tools regarding the N60 sampling method which 

prevented standardized application across all of the beef industry. BIFSCo created 

a training video which provides a visual tool for companies to use and it accompanies written best practices, a how-to guide, for the N60 sampling method which 

are available to the public at www.bifsco.org. N60 has been accepted as the industry 

standard for sampling, and BIFSCo has worked with FSIS to have the video and 

best practices document distributed to 675 federally inspected facilities. 

Every year The Beef Checkoff funds a variety of research focused on consumers 

in order to assess their knowledge of beef safety. The research found that a substantial number of consumers did not properly handle and cook ground beef products. 

Since everyone plays an important role in beef safety NCBA developed Safe and Savory at 160 to emphasize the steps consumers should take to ensure food safety in 

their homes. Consumers can find tips and tools about safe food storage, handling 

and preparation, instructional videos and new burger recipes online at 

www.safeandsavory160.com.

NCBA supports the establishment of realistic food safety objectives designed to 

protect public health to the maximum extent possible. It is important that the objectives be based on sound science with the realistic understanding that even under 

the best science-based operating procedures achieving zero is not possible. NCBA 

encourages FSIS to incorporate the objectives of existing regulatory programs, including HACCP and the Pathogen Reduction Act, which focus on process controls 

rather than testing as a means to protect public health. 

However, utilizing science-based principles and validating interventions used 

throughout the process effectively control the associated risks of E. coli O157:H7. 

NCBA will continue the industry-wide collaboration efforts to educate consumers, 

the beef industry and regulatory authorities about science-based strategies that are 

realistic and can be utilized in raw beef production to reduce food safety risks. 

As Congress continues to discuss food safety we encourage you to work with 

USDA’s Food Safety and Inspection Service (FSIS) and the regulated industries to 

achieve the common goal of food safety. It’s essential that policymakers and regulators have a working knowledge and understanding of the industry and the processes it uses to produce safe beef products. The knowledge base is crucial so regulations do not become burdensome, be impractical or too costly for the industry to 

apply. 

Also, it is important for Congress to focus on the resources FSIS needs to effectively implement the science- and risk-based regulations that are already in place. 

It is imperative for USDA to increase ARS funding of food safety research. In order 

to achieve the goal of food safety, we have to understand the science of the pathogen 

and interventions that may be used to control not only the pathogen but also the 

environment. 

39

We encourage USDA to work with industry when planning educational or outreach events. This will help to ensure the necessary information is presented in a 

manner where attendees can easily understand the concepts and we encourage the 

use of interactive or ‘‘hands-on’’ demonstrations. Just as important is the need for 

employee training and the communication of any new regulatory changes to FSIS 

inspectors in the field so that there is not any confusion or misinterpretation of the 

law. We realize that communicating regulatory changes to personnel throughout the 

country is a challenge, but this is an area of concern for the beef industry that needs 

to be addressed. With regards to small and very small operations, there is a greater 

need of information and resources from USDA to be provided for these small businesses to utilize. BIFSCo has developed a series of ‘‘Best Practice’’ documents for 

the beef industry and several are targeted for the small and very small operations 

to use. We will continue our outreach to small and very small plants with educational materials and encourage USDA to place a stronger focus on communicating 

and providing information to these small businesses. 

Last, consumers will always play an important role to ensure that their food is 

safe. The beef industry has numerous resources for consumers to access to learn 

more about proper storage, handling and cooking of beef products. Any assistance 

the Federal Government could provide to ensure consumers are aware of these resources or know how to utilize them would be appreciated. The beef industry remains committed to safety, however, imposing new rules or regulations that are not 

based on science, risk assessments and industry application will only hinder food 

safety efforts. 

Another area of concern for beef producers is the misconception that an animal 

identification program is a necessary component for food safety. Animal identification programs are tools to help monitor and trace in the event of an animal health 

emergency. Animal ID systems do not enhance food safety, nor were they ever intended to. In addition, animal ID systems do not prevent animal disease; they are 

only a tool to help contain them. Producers currently utilize animal identification 

for herd management, genetic improvement and as a positive tool for their operations’ marketing program. 

In closing, the beef industry will continue our multiple-hurdle approach to address 

food safety. It is imperative for our government to use sound science when evaluating the effectiveness of pre- and post-harvest interventions and programs to address food safety concerns. Science-based intervention and management strategies 

coupled with safe food handling techniques, will help our industry reach its goal of 

providing a safe, high-quality product for the consumer. The beef industry cannot 

afford for the government to have an unscientific mis-step that removes or limits 

valuable interventions as options for the industry to utilize for beef safety. 

I appreciate the opportunity to testify today about the beef industry’s role in food 

safety. I have attached some background information on the beef industry and beef 

safety which you may find helpful. We look forward to working with you in the future.

40

ATTACHMENT 1


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ATTACHMENT 2


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ATTACHMENT 3


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The CHAIRMAN. Thank you, Dr. Reagan. Ms. Appell. 

STATEMENT OF JILL APPELL, PAST PRESIDENT, NATIONAL 

PORK PRODUCERS COUNCIL; PORK PRODUCER, APPELL’S 

PORK FARMS, INC., ALTONA, IL 

Ms. APPELL. Good afternoon, Chairman Scott, Ranking Member 

Neugebauer, and Members of the Subcommittee. My name is Jill 

Appell, and I am a pork producer from Altona, Illinois and past 

President of the National Pork Producers Council. I am pleased to 

present the pork industry’s views on food safety. NPPC is an association of 43 state pork producer organizations and voice of the 

pork industry in Washington. Nationwide, more than 67,000 pork 

producers generate $34 billion of gross national product and support 550,000, mostly rural, jobs. They provide 20 billion pounds of 

safe and nutritious pork annually. Producing safe pork begins on 

the farm, and pork producers have a long history of enhancing the 

safety of their products. 

The industry developed the Pork Quality Assurance® Program in 

1989 and refined it in 2007. The program identifies practices that 

are potential food safety hazards and minimizes the risk through 

producer education. Many major packers require PQA Plus® certification as a condition for sale. Last year, the industry launched the 

We Care program which stresses ethical principles including promoting animal well-being, producing safe food, and protecting public health. Fundamental to an effective Federal food safety system 

is adequate funding and enough personnel, including inspectors, to 

protect public health. Pork producers support increased public 

funding to improve all food safety operations. In particular, they 

urge Federal agencies to improve compensation for veterinarians. 

In addition, food safety agencies must have policies based on sound 

science. 

For the most part, USDA’s Food Safety and Inspection Service 

does a good job. Recently, we were pleased that FSIS advised its 

veterinarians and inspectors on how to handle fatigued pigs, although consistencies in applying the guidelines still persist. There 

is always room for improvement. Responses to animal or to human 

health events must be coordinated better, and protocols for reporting and sharing foodborne illness information should be consistent. 

Communication on all levels should be improved to quickly address 

problems. Another area that clearly needs improvement is plant 

closings. Recently, FSIS has shut plants because one pig was handled improperly. As a result, hundreds of pigs en route to the plant 

were left on trailers for hours. We need guidelines to ensure an appropriate response to animal welfare issues in plants. 

The pork industry also supports full funding for both the National Antimicrobial Resistance Monitoring System, NARMS, which 

monitors antimicrobial resistance on the farm, in the meat case, 

and in human foodborne illness, and the Collaboration in Animal 

Health and Food Safety Epidemiology, CAHFSE, which monitors 

bacteria on farms and in plants. Pork producers also make the following specific recommendations: link food safety objectives to public health outcomes rather than arbitrary targets; improve food 

safety communication among state and Federal public health officials and the industry; encourage FSIS, veterinarians and inspecVerDate 0ct 09 2002 11:26 Oct 02, 2009 Jkt 041481 PO 00000 Frm 00047 Fmt 6633 Sfmt 6601 I:\DOCS\111-10\52575.TXT AGR1 PsN: BRIAN
44

tors to apply the guidelines for fatigued pigs consistently; fully 

fund programs that monitor antimicrobial resistance; require FSIS 

to follow its procedures for testing pork for antibiotic residues; base 

best handling practices for processing facilities on science; establish 

proportional responses to animal welfare issues that might arise at 

processing facilities; improve the ability of FSIS and FDA to maintain the workforce necessary to carry out inspections that ensure 

the safety of food. 

Pork producers have an obligation to produce a safe product, and 

we are committed to continuous improvement to ensure a safe food 

supply. We need the nation’s food safety agencies to work in partnership to meet that shared obligation. Mr. Chairman, thank you 

for allowing NPPC to present its views on food safety, and I look 

forward to any questions. 

[The prepared statement of Ms. Appell follows:]

PREPARED STATEMENT OF JILL APPELL, PAST PRESIDENT, NATIONAL PORK

PRODUCERS COUNCIL; PORK PRODUCER, APPELL’S PORK FARMS, INC., ALTONA, IL 

Introduction 

The National Pork Producers Council (NPPC) is an association of 43 state pork 

producer organizations and serves as the voice in Washington, D.C., of America’s 

67,000 pork producers. 

The U.S. pork industry represents a significant value-added activity in the agriculture economy and the overall U.S. economy. In 2008, it marketed more than 110 

million hogs, and those animals provided total gross receipts of $15 billion. Overall, 

an estimated $21 billion of personal income and $34.5 billion of gross national product are supported by the U.S. hog industry. Iowa State University economists Dan 

Otto and John Lawrence estimate that the U.S. pork industry is directly responsible 

for the creation of nearly 35,000 full-time equivalent jobs and helps generate an additional 515,000 indirect, mostly rural, jobs. 

The U.S. pork industry today provides about 20 billion pounds of safe, wholesome 

and nutritious meat protein to consumers worldwide. 

Like many other segments of the U.S. economy, the pork industry has suffered 

through some tough economic times over the past 18 months. Last year, U.S. pork 

producers lost an average of $22 on each hog marketed, and it has been estimated 

that the industry, as a whole, has lost between $3 billion and $3.5 billion in equity 

since September 2007. 

The industry’s one bright spot has been exports, which have helped temper U.S. 

pork producers’ losses. In 2008, the United States exported 2.05 million metric tons, 

or 4.4 billion pounds, of pork valued at nearly $5 billion. Last year was the 17th 

consecutive year of record pork exports. 

America’s pork producers have been dedicated to maintaining and enhancing the 

quality and safety of U.S. pork for decades. Pork producers are committed to continuous improvement of production practices, including animal care and welfare, and 

in implementing on-farm practices that safeguard animals and the public health 

while producing wholesome and affordable pork products for consumers around the 

world. 

Last year, the pork industry renewed its commitment to continuous improvement 

by launching the ‘‘We Care’’ program, which includes Ethical Principles for U.S. 

Pork Producers. Producing safe food is one of the important principles. Pork producers are committed to using production practices, managing animal health and 

managing technology to produce safe pork. 

Pork Is a Safe Protein 

Producing safe, wholesome pork products is a continuum that begins on the farm. 

Pork producers work in collaboration with their veterinarians to design herd health 

programs, which promote healthy hogs and, in turn, produce safe pork. These programs may include diagnostics for determining the best time to vaccinate for diseases or the best time to use antibiotics for preventing a disease outbreak. The 

health management plans also may include information on ventilation of the barns, 

balanced feed rations and parasite control. The herd health management programs 

have been created and tailored to each production system and often to individual 

farms. 

45

Keeping pigs healthy is not only the right thing to do, but it is also important 

for producing safe pork. Dr. Scott Hurd of Iowa State University demonstrated that 

when pigs have been sick during their life, those pigs will have a greater presence 

of food pathogens on carcasses. This study reinforces the importance of using all of 

the tools available to protect the health of animals. 

Overarching Concepts 

Ensuring that our food is safe is the purview of 15 different agencies; the principle 

agencies are the U.S. Department of Agriculture’s Food Safety Inspection Service 

(FSIS), which oversees meat and poultry processing facilities, and the U.S. Department of Health and Human Service’s Food and Drug Administration (FDA), which 

regulates food other than meat and poultry but also has jurisdiction over animal 

feed and veterinary products. 

U.S. pork producers believe there are fundamental elements to an efficient and 

effective food safety system. First, the U.S. food safety system needs adequate public 

funding. U.S. pork producers support increased Federal appropriations to finance 

improvements in all food safety operations. Food safety functions are a broad benefit 

to society; these functions are not something reserved just for the food industry. So, 

U.S. pork producers oppose the imposition on processing facilities of registration 

fees, user fees or re-inspection fees. (The latter could create a powerful incentive for 

inspectors to seek out food safety violations where there may not be any.) The cost 

of any such fees is likely to be passed on to pork producers and consumers at a time 

when they can least afford it. 

U.S. pork producers also believe that our food safety system needs adequate numbers of trained personnel, including inspectors, to accomplish the goal of protecting 

public health. FSIS has a staff of 8,000 employees to oversee 6,300 domestic facilities; FDA has 1,900 employees to oversee 13,600 domestic facilities. In Fiscal Year 

2008, FSIS sought to employ 1,134 veterinarians but had only 968 veterinarians. 

Of that number, 466 or 48 percent are eligible to retire in the next 5 years. This 

will be a significant hit to FSIS’s work force. A recent report from the Government 

Accountability Office found that FSIS has a vacancy rate for veterinarians of up to 

35 percent. 

The future of an effective American food safety system hinges on having adequate 

personnel in processing facilities. U.S. pork producers support the American Veterinary Medical Association’s call for Federal agencies to improve compensation packages, including better salaries, to help recruit and retain veterinarians. 

In addition to adequate funding and personnel, food safety regulatory agencies 

must have policies and procedures based on sound science and ones that help industry produce safe products. For the most part, the agency charged with the safety 

of pork and other meat and poultry products, FSIS, meets those criteria and does 

a good job. 

What FSIS Does Well 

FSIS is built on an inspection-based model. FSIS veterinarians and inspectors are 

in plants to allow them to operate. FSIS also has adequate enforcement authority. 

Establishments subject to the Federal Meat Inspection Act are required to notify 

USDA of the amount, origin and destination of any adulterated or misbranded meat 

product they believe has entered the food supply. That requirement is the regulatory 

equivalent of mandatory recall; FSIS can seize and detain affected product if a company refuses to conduct a voluntary recall. To date, no company has refused an 

FSIS recall. 

A critical piece to protecting public health is preventing foodborne illness before 

it happens. The Hazard Analysis Critical Control Point or Pathogen Reduction/

HACCP system that is used in U.S. meat and poultry plants provides a preventive 

approach to food safety. Mandatory HACCP creates the framework for strong food 

safety controls. HACCP assures that processes in pork plants are monitored by industry and includes a sound system for verification by inspection. Thousands of 

microbiological tests are run in pork plants annually. Written sanitary programs 

also are in place in every pork plant; FSIS verifies these plans before a plant can 

operate. A recall of meat or poultry is viewed as a failure in the system to prevent 

a potential hazard. However, when a product is identified as being a risk and is 

quickly pulled from the market, it could also be viewed as a successful culmination 

of a process that is designed to protect public health. 

While some may view FSIS’s treatment of imports as overly critical, FSIS truly 

has a system for handling imports that protects U.S. agriculture. The laws and regulations of an importing country must be determined by USDA to be equivalent to 

those of the United States. The country’s processing facilities are then inspected by 

FSIS personnel before a product can be shipped into the U.S. Inspections are conVerDate 0ct 09 2002 11:26 Oct 02, 2009 Jkt 041481 PO 00000 Frm 00049 Fmt 6633 Sfmt 6621 I:\DOCS\111-10\52575.TXT AGR1 PsN: BRIAN
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ducted of establishments, laboratories and the inspection process itself in the importing country. Finally, all product entering the U.S. is subject to re-inspection by 

FSIS upon importation at the border. 

Collaboration with other agencies is another task that FSIS does well. When FSIS 

veterinarians and inspectors find lesions for reportable diseases, such as tuberculosis, for example, they submit samples and notify USDA’s Animal and Plant 

Health Inspection Service (APHIS) veterinarians to conduct tracebacks to farms 

where animals originated. APHIS veterinarians then work with state veterinarians 

to visit farms and conduct the appropriate testing and tracebacks to other farms. 

Early last year, there were inconsistencies in how FSIS veterinarians and inspectors inspected fatigued pigs at plants. During the transport of pigs to harvesting facilities, some pigs become fatigued. ‘‘Fatigue’’ is a temporary condition in pigs without obvious injury, trauma or disease. They fall behind their contemporaries as they 

are being moved and may refuse to take multiple steps. Most fatigued pigs recover 

if rested. FSIS does not record the number of fatigued pigs. However, data from 

FSIS show that 0.8 to 1 percent of the roughly 110 million hogs marketed in the 

U.S. each year become non-ambulatory from fatigue or injury during transport or 

shortly after unloading. Fatigued pigs also pose no threat to food safety. There is 

no scientific evidence that pigs harbor or can become infected with BSE (Bovine 

Spongiform Encephalopathy). During the outbreak of BSE in England in the mid 

1990s, pigs were fed BSE-infected bovine brain material and showed no evidence of 

any type of Transmissible Spongiform Encephalopathy (TSE) disease over the 2 to 

7 year period in the study. This evidence from Great Britain and research conducted 

by USDA’s Agricultural Research Service (ARS) demonstrated that pigs are resistant to BSE following oral exposure with large doses of infected material. No case 

of naturally-acquired TSE has ever been demonstrated in pigs. 

FSIS did an extensive look at the science on fatigued pigs and issued a questionand-answer guidance to its veterinarians and inspectors on how fatigued pigs should 

be handled and inspected. This guidance was made available on February 9, 2009. 

U.S. pork producers encourage FSIS veterinarians and inspectors to apply the 

guidelines consistently across the industry. 

Areas for Improvement 

Responding to any animal health or human health event needs to be a coordinated effort between Federal and state governments, as well as industry. Some 

states have excellent health departments with good protocols in place for collecting 

and sharing information on foodborne illnesses with the Federal Government. But 

this is not the case for all 50 states. Because of inconsistencies across states and 

a lack of communication, food recalls, for example, have been slowed. U.S. pork producers believe there needs to be consistency across states on the protocols for reporting and sharing information with the Federal Government on foodborne illnesses. 

We also believe that communication needs to be better among state public health 

officials, Federal public health officials and the industry so that problems can be 

quickly identified and addressed. There also should be a concerted effort by USDA 

and HHS to communicate better with each other. These improvements in communication and coordination will help recalls be carried out in a timely manner and 

will provide more safeguards for safe food. 

A specific area that needs to be addressed is how FSIS handles plant closings. 

U.S. pork producers have an obligation to handle pigs humanely during the loading 

and unloading of trucks as they are moved to market. Our partners in the plant 

have the same obligation in the holding pens and the stunning area. However, situations have arisen recently where one pig in a plant is handled inhumanely, the 

plant is shut down and hundreds of pigs en route to the plant—or at the plant but 

still on trucks—are not allowed to be unloaded. U.S. pork producers strongly agree 

that pigs should be humanely handled at all times, but shutting down a plant for 

an inhumane action against one pig can leave hundreds of pigs on trailers for hours, 

resulting in pig deaths. The U.S. meat packing industry uses a ‘‘just-in-time’’ delivery system, meaning U.S. pork producers’ transporters are given a window of time 

to arrive at the plant with their load. If producers do not hear from the plant, pigs 

are loaded to meet the scheduled arrival time at the plant. Shutting down a plant 

for an inhumane handling situation is part of an old regulation that does not recognize the changes in the U.S. pork industry. This is an operational issue at FSIS that 

affects producers, and it calls for the development of guidelines that ensure an appropriate, proportional response to animal welfare issues in plants. 

Funding for vital food safety monitoring programs is another area that can and 

should be addressed. 

The National Antimicrobial Resistance Monitoring System (NARMS) was established in 1996 as a collaborative effort between the FDA Center for Veterinary MedVerDate 0ct 09 2002 11:26 Oct 02, 2009 Jkt 041481 PO 00000 Frm 00050 Fmt 6633 Sfmt 6621 I:\DOCS\111-10\52575.TXT AGR1 PsN: BRIAN
47

icine (CVM), USDA and the Centers for Disease Control and Prevention (CDC). 

NARMS is funded through FDA appropriations and is an important tool used to 

monitor antimicrobial resistance in selected enteric bacteria on the farm, in the 

meat case and in human foodborne illness. The ultimate goal of NARMS is to prolong the lifespan of approved antibiotics by promoting responsible use and to identify areas for more investigation. The U.S. pork industry has supported NARMS 

since its creation and supports the full funding of NARMS. 

The Collaboration in Animal Health and Food Safety Epidemiology (CAHFSE) is 

another project that the U.S. pork industry has supported. It is a joint effort among 

three agencies of USDA: APHIS, ARS and FSIS. The mission is to enhance overall 

understanding of bacteria that pose a food-safety risk by monitoring these bacteria 

at the farm and plant levels over time and correlating any change with on-farm animal health or antimicrobial use. The pork industry was the first food animal group 

to cooperate in the development of the CAHFSE program. CAHFSE has not received 

any money for the last 2 fiscal years. It provides important surveillance data and 

is unlike any other surveillance program. The U.S. pork industry supports the full 

funding of the CAHFSE program. 

Concerns With Legislative Proposals 

A number of food safety bills propose granting FSIS and FDA authority to order 

food off the market if it poses a serious health risk and a company refuses a voluntary recall. U.S. pork producers believe that such mandatory recall authority is 

unnecessary. The regulatory agencies have tools for removing products from commerce and for taking enforcement action if a company refuses a recall. Furthermore, 

under the 2008 Farm Bill, establishments subject to the Federal Meat Inspection 

Act are required to notify USDA of the amount, origin and destination of any adulterated or misbranded meat product they believe has entered the food supply. U.S. 

pork producers oppose mandatory recall authority unless it is limited to situations 

posing very serious health risks and gives processors the opportunity to issue their 

own recall first. The voluntary system has worked well in removing unsafe products 

from the market in a timely manner. Mandatory recall authority could undermine 

today’s cooperative arrangement between government and the food industry. 

Currently, there are performance standards for acceptable levels of some pathogens on pork. There is some talk of expanding the standards to a host of additional 

pathogens. These standards must be correlated to public health outcomes not based 

on arbitrary baselines, as was the case for Salmonella. The Salmonella performance 

standards for pork—and other meat and poultry commodities—were created in the 

early 2000s with the intention of adjusting them as necessary after processing facilities fully implemented HACCP. HACCP decreased Salmonella counts on pork by 55 

percent between 2000 and 2007. Yet the number of cases of salmonellosis in humans 

rose five percent during that same period. 

U.S. pork producers believe that creating arbitrary performance standards is not 

beneficial to the U.S. pork industry or its consumers. Food safety objectives linked 

to public health outcomes is a better approach for safeguarding consumers from 

foodborne illnesses from meat and poultry products. Further, the use of food safety 

objectives is more in line with international objectives as outlined by the Codex 

Alimentarius.

Expanding on-farm inspections also may be considered during debate on various 

food safety bills. The U.S. pork industry opposes such an expansion. U.S. pork producers have worked over the years to develop a working relationship with USDA’s 

APHIS veterinarians. APHIS has the infrastructure and relationships with producers to address on-farm animal health issues. U.S. pork producers do not believe 

that on-farm authority should be extended beyond what currently exists. 

U.S. Pork Industry’s Commitment To Safe Food 

While the Federal Government plays a vital role in keeping our food supply safe, 

the first line of defense is producers themselves. The U.S. pork industry has a long 

history of not only producing safe food but developing and implementing programs 

and policies that have ensured and enhanced the safety of pork. 

The U.S. pork industry in 1989 developed the Pork Quality Assurance® program, 

a producer education and certification program to reduce the risk of violative animal 

health product residues in pork. 

The program, better known as PQA®, was modeled after HACCP programs used 

by food manufacturers to ensure the safety of food products but customized for onfarm use. PQA® was designed to identify the practices with potential to result in 

a food safety hazard and minimize this potential risk through producer education 

on relevant on-farm practices. 

48

The success of the program was demonstrated by significant producer participation, customer acceptance and, more importantly, a measurable reduction in the instances of violative residues in pork. The program was revised repeatedly—approximately every 5 years—with updated content taken from new scientific knowledge, 

to address the evolving industry and changing production practices. In the mid1990s, for example, the program added content to help producers care for their animals in a manner that promotes animal well-being. 

In 2007, PQA® evolved into PQA Plus® to reflect increasing customer and consumer interest in the way food animals are raised. PQA Plus® was built as a continuous improvement program. The PQA Plus® program focuses on food safety and animal well-being. The food safety element includes practices that minimize physical, 

chemical or biological hazards that might cause injury to consumers. The program 

also includes an on-farm assessment where animal well-being and elements of food 

safety good production practices are assessed. Our producers are told that food safety is not optional. Many major pork packers require PQA Plus® certification as a 

condition of sale. 

The industry will continue to change and modify PQA Plus® as new technologies 

and science become available. U.S. pork producers know their businesses better 

than anyone and have the flexibility to make changes to their practices and programs to improve the safety of their product. 

U.S. pork producers do not believe the Federal Government should develop industry standards for two reasons:

1. As it did for the PQA® and PQA Plus® programs, the U.S. pork industry 

brings industry experts around the table to design industry programs. This 

gives producers ownership of the programs, and that facilitates participation 

and compliance.

2. Government-developed production standards would be harder to change and 

could not respond quickly to new technologies and science. 

Industry Efforts Have Worked 

U.S. pork producers’ long-standing commitment to producing safe and wholesome 

pork product has paid dividends. For example, FSIS since 1996 has routinely tested 

sows, boars and stags, show pigs, roaster pigs and market hogs for various antibiotic 

residues, and since then the total number of residue violations has been reduced by 

nearly 50 percent. For each year, the overall violative residue percentage has not 

risen above 0.35 percent and was as low as 0.13 percent. The U.S. pork industry 

supports FSIS in following the processes and procedures that it has in place for testing and monitoring for antibiotic residues in pork. 

As another example, FSIS established Salmonella performance standards for market hog carcasses. When the standards were set, there was an 8.7 percent prevalence of Salmonella on carcasses. Following several years of testing, that percentage 

fell to an industry average of 2.8 percent in 2007. In 2008, the percentage of pork 

carcasses with Salmonella was 3.4, 2.9, 2.0 and 2.0 percent, respectively, for each 

quarter of the year. 

Summary of Recommendations 

With producing safe food as one of its top priorities, the U.S. pork industry will 

continue to adopt and adapt practices and programs that improve the safety of our 

nation’s food supply. America’s food producers need the Federal Government to be 

a partner in this effort. To that end, the U.S. pork industry makes the following 

recommendations for improving the U.S. food safety system:

• Establish food safety objectives linked to public health outcomes.

• Improve communication about food safety issues among state public health officials, Federal public health officials and the industry.

• Encourage FSIS veterinarians and inspectors to apply the guidelines for fatigued pigs consistently across the industry.

• Fully fund NARMS and CAHFSE.

• Require FSIS to follow its processes and procedures for testing pork for antibiotic residues.

• Base best handling practices and inspections for processing facilities on science.

• Establish, with input from all stakeholders, proportional responses to animal 

welfare issues that arise at processing facilities.

• Improve the ability of FSIS and FDA to hire and maintain the work force necessary to carry out inspections that ensure the safety of food. 

49

Summary 

The U.S. pork industry has an obligation to produce a safe, wholesome product 

for domestic and international consumers, and that obligation is shared by Federal 

regulatory agencies. The burden of safe food cannot be placed solely on the shoulders of industry. U.S. pork producers are committed to continuous improvement; 

they are also committed to maintaining the safest food supply in the world.

The CHAIRMAN. Thank you. Dr. Krushinskie. 

STATEMENT OF DR. ELIZABETH A. KRUSHINSKIE, DIRECTOR 

OF QUALITY ASSURANCE AND FOOD SAFETY, MOUNTAIRE 

FARMS, INC., MILLSBORO, DE; ON BEHALF OF NATIONAL 

CHICKEN COUNCIL 

Dr. KRUSHINSKIE. Thank you, Mr. Chairman, and Members of 

the Committee. My name is Elizabeth Krushinskie. I am the Director of Quality Assurance and Food Safety for Mountaire Farms, 

Inc. in Millsboro, Delaware. I have worked on quality assurance 

and food safety issues in various capacities within the poultry industry for over 15 years. I am pleased to testify today on behalf of 

the National Chicken Council. NCC is the national trade association representing the country’s broiler producing and processing industry. This afternoon, I would like to share with you information 

about the regulatory framework that governs the poultry industry 

and the success that our industry, in partnership with the government, has had in ensuring the safety of the food we produce. 

The broiler chicken industry has always taken very seriously its 

obligation to produce safe, wholesome, high quality products. One 

of the basic reasons chicken is the most popular meat in America 

is the trust and confidence consumers have in the food safety of our 

products. The U.S. chicken industry’s track record is unmatched 

with more than 37 billion pounds of chicken having been processed 

in 2008, and a per capita consumption of 85 pounds per person. 

The success of our brand names depends upon consumer confidence, something we strive to earn every day. Our industry is 

continually investing in research and development of the most effective and advanced food processing technology and food processing systems, which is why U.S. consumers enjoy the safest and 

most abundant food supply in the world. 

In addition, the poultry industry is subject to strict regulation by 

USDA’s Food Safety and Inspection Service. All plants producing 

poultry products operate under continuous inspection by FSIS. No 

poultry product may enter interstate commerce if it has not been 

produced under inspection. FSIS may suspend operations of a facility or detain product when food safety concerns arise. And, imported meat and poultry products are not permitted into the U.S. 

commerce unless produced under standards equivalent to those established by FSIS and applied to domestically produced products. 

Companies violating FSIS regulations are subject to severe administrative sanctions and criminal penalties. 

All poultry plants follow detailed food safety plans that are designed by the plants to address potential food safety hazards that 

may occur in the processing of their products. The Hazard Analysis 

and Critical Control Points System was developed and voluntarily 

implemented by the food industry more than 4 decades ago. Under 

HACCP, plants analyze their production systems, identify all potential physical, biological and chemical hazards that may occur, 

50

and adopt controls to prevent or reduce those hazards that are reasonably likely to occur in processing. In 1996, FSIS made HACCP 

mandatory, but the industry had already relied upon HACCP principles to ensure food safety. 

In addition to HACCP, FSIS requires plants to adopt and follow 

sanitation standard operating procedures or SSOPs to reduce the 

likelihood that harmful bacteria will contaminate finished product. 

FSIS also sets pathogen reduction performance standards for Salmonella that poultry plants must meet for certain raw poultry 

products, and verifies that plants are meeting the standards. In reviews of the effectiveness of HACCP and the performance standards, FSIS has reported that the vast majority, in fact, nearly all, 

broiler plants are complying with the Salmonella performance 

standards, and that Salmonella prevalence, in most product categories, is lower since HACCP implementation than in baseline 

studies conducted before implementation. 

In 2006, the agency began posting industry performance categories to highlight how well the industry was doing in meeting the 

Salmonella standards, and these data reveal remarkable improvements. Between the first quarter of 2006 and the 4th quarter of 

2008, the percent of broiler establishments operating at the category I performance level, that is, achieving Salmonella prevalence 

levels averaging less than ten percent, increased from 35.5 percent 

of plants to 82 percent. The key to success with HACCP has been 

industry’s commitment to food safety. FSIS mandates HACCP 

plans and verifies compliance with the plans, but it is the plants 

that conduct hazard analyses and adopt and implement controls to 

address potential food safety hazards. 

The role of government is to ensure that plants have effective 

plans and comply with applicable regulations governing their implementation. It is not government’s responsibility to second guess 

a plant’s hazard analyses or controls determined to be appropriate 

for a specific product or establishment. It is critically important 

that each plant has the flexibility to tailor its HACCP system to 

its unique circumstances. This has been paramount to the success 

of the poultry industry in addressing potential food safety hazards. 

To be clear, poultry products are subject to stringent regulation, 

and FSIS has a broad arsenal of enforcement authority. Yet, the 

poultry industry’s success in making safe and wholesome products 

has been achieved by the industry working in cooperation with 

FSIS to reduce potential food safety hazards and, thereby, ensure 

consumer safety. I would like to thank you for the opportunity to 

speak today. 

[The prepared statement of Dr. Krushinskie follows:]

PREPARED STATEMENT OF DR. ELIZABETH A. KRUSHINSKIE, DIRECTOR OF QUALITY

ASSURANCE AND FOOD SAFETY, MOUNTAIRE FARMS, INC., MILLSBORO, DE; ON

BEHALF OF NATIONAL CHICKEN COUNCIL

Good morning. My name is Elizabeth Krushinskie. I am Director of Quality Assurance and Food Safety at Mountaire Farms, Inc. in Millsboro, Delaware, and have 

worked on quality assurance and food safety issues in various capacities within the 

poultry industry for over 15 years. I am pleased to testify today on behalf of the 

National Chicken Council. NCC is the national trade association representing the 

country’s broiler producing and processing industry. This morning, I would like to 

share with you information about the regulatory framework that governs the poulVerDate 0ct 09 2002 11:26 Oct 02, 2009 Jkt 041481 PO 00000 Frm 00054 Fmt 6633 Sfmt 6621 I:\DOCS\111-10\52575.TXT AGR1 PsN: BRIAN
51

try industry and the success that our industry, in partnership with the government, 

has had in ensuring the safety of the food we produce. 

The broiler chicken industry has always taken very seriously its obligation to 

produce safe, wholesome, high quality products. One of the basic reasons chicken 

is the most popular meat in America is the trust and confidence consumers have 

in the food safety of our products. The U.S. chicken industry’s track record is unmatched with more than 37 billion pounds of chicken having been processed in 2008 

and a per capita consumption of 85 pounds. The success of our brand names depends upon consumer confidence, something we strive to earn every day. Our industry is continually investing in research and development of the most effective and 

advanced food processing technology and food safety systems, which is why U.S. 

consumers enjoy the safest and most abundant food supply in the world. 

In addition, the poultry industry is subject to strict regulation by USDA’s Food 

Safety and Inspection Service (FSIS). All plants producing poultry products operate 

under continuous inspection by FSIS. No poultry product may enter interstate commerce if it has not been produced under inspection. FSIS may suspend operations 

of a facility or detain product when food safety concerns arise. And, imported meat 

and poultry products are not permitted entry into U.S. commerce unless produced 

under standards equivalent to those established by FSIS and applied to domestically 

produced products. Companies violating FSIS regulations are subject to severe administrative sanctions and criminal penalties. 

All poultry plants follow detailed food safety plans that are designed by the plants 

to address potential food safety hazards that may occur in the processing of their 

products. The Hazard Analysis and Critical Control Points (HACCP) system was developed and voluntarily implemented by the food industry more than 4 decades ago. 

Under HACCP, plants analyze their production systems, identify all potential physical, biological and chemical hazards that may occur, and adopt controls to prevent 

or reduce those hazards that are reasonably likely to occur in processing. In 1996, 

FSIS made HACCP mandatory, but the industry had already relied upon HACCP 

principles to ensure food safety. 

In addition to HACCP, FSIS requires plants to adopt and follow written Sanitation Standard Operating Procedures (SSOPs) to reduce the likelihood that harmful 

bacteria will contaminate finished product. FSIS also sets pathogen reduction performance standards for Salmonella that poultry plants must meet for certain raw 

poultry products, and verifies that plants are meeting the standards. 

In reviews of the effectiveness of HACCP and the performance standards, FSIS 

has reported that the vast majority of plants are complying with the Salmonella

performance standards and that Salmonella prevalence, in most product categories, 

is lower since HACCP implementation than in baseline studies conducted before implementation. In 2006, the agency began posting industry performance categories to 

highlight how well the industry was doing in meeting the Salmonella standards, 

and these data reveal remarkable improvements. Between the first quarter of 2006 

and the fourth quarter of 2008, the percent of broiler establishments operating at 

the category I performance level—achieving Salmonella prevalence levels averaging 

less than 10%—increased from 35.5% to 82%. 

The key to success with HACCP has been industry’s commitment to food safety. 

FSIS mandates HACCP plans and verifies compliance with the plans, but it is the 

plants that conduct hazard analyses and adopt and implement controls to address 

potential food safety hazards. The role of government is to ensure that plants have 

effective plans and comply with applicable regulations governing their implementation; it is not government’s responsibility to second guess a plant’s hazard analyses 

or controls determined to be appropriate for a specific product or establishment. It 

is critically important that each plant has the flexibility to tailor its HACCP system 

to its unique circumstances. This has been paramount to the success of the poultry 

industry in addressing potential food safety hazards. 

To be clear, poultry products are subject to stringent regulation, and FSIS has a 

broad arsenal of enforcement authority. Yet, the poultry industry’s success in making safe and wholesome products has been achieved by the industry working in cooperation with FSIS to reduce potential food safety hazards and, thereby, ensure 

consumer safety. 

I am aware that the Congress is currently considering several bills to modernize 

the nation’s food safety laws. To the best of my knowledge, none of these bills would 

expand FSIS regulatory authority. Since FSIS regulation is already pervasive, the 

agency does not need more power. And I am not here to discuss what authority 

might be appropriate for the Food and Drug Administration in its regulation of 

other foods. 

I do want to stress, however, that adequate funding for FDA is an essential first 

step toward food safety modernization. FDA has operated with less than adequate 

52

funding for too many years. Giving FDA more regulatory power would be useless 

without first adequately funding the agency. 

And, although adequate funding is crucial to the effectiveness of any regulatory 

agency, user fees are not the answer. Congress should continue to fund regulatory 

agencies through appropriations. User fees have been proposed for FDA activities 

such as sampling of imported foods, recall effectiveness checks, and investigations 

of potential sources of contamination. Over the years, there have been various proposals to fund FSIS inspection through similar user fees imposed on the meat and 

poultry industries. Each time such a proposal has been considered, it has been rejected because these activities are central to the government’s role in enforcing the 

law; they are government activities, not voluntary services for which companies receive commercial benefits. 

In short, the chicken industry has done a very good job at producing safe, wholesome, high quality foods. The industry is continually developing new interventions 

and related technologies, and refining its food safety systems, to enhance food safety. Although FSIS regulation is strict, it has been industry’s commitment to cooperating with the government by complying with those regulations but independently 

seeking new and more effective ways to produce products that consumers can enjoy 

and trust. 

Thank you for this opportunity to testify this morning. I would be pleased to respond to questions or supplement my statement as may be useful to the Committee.

The CHAIRMAN. Thank you very much. Dr. Rybolt. 

STATEMENT OF MICHAEL L. RYBOLT, PH.D., DIRECTOR,

SCIENTIFIC AND REGULATORY AFFAIRS, NATIONAL TURKEY 

FEDERATION, WASHINGTON, D.C. 

Dr. RYBOLT. Good afternoon, Chairman Scott, Ranking Member 

Neugebauer, and Members of the Subcommittee, my name is Michael Rybolt, and I am the Director for Scientific and Regulatory 

Affairs for the National Turkey Federation. NTF, which represents 

more than 99 percent of the U.S. turkey industry, greatly appreciates the opportunity to be here today. Food safety is the turkey 

industry’s priority, and our members agreed years ago that food 

safety is an issue on which they would cooperate, not compete. Federal inspection of meat and poultry products has undergone a revolution of sorts in the last 13 years, and the collaborative efforts of 

industry and USDA have resulted in some notable accomplishments. 

The turning point was the HACCP rule in 1996. As previously 

discussed, HACCP created a system by which companies designed 

food safety plans aimed at identifying the points in production 

where food safety hazards are likely to occur, and then devising 

processes to control those hazards. Further, the establishments 

were required to have programs for ensuring they maintain the 

highest level of sanitary conditions in their facilities, also known as 

SSOPs. The current statute also requires that FSIS provide continuous bird-by-bird inspection in order for the mark to be applied to 

poultry products before being distributed in commerce. This requires FSIS inspectors to visually inspect each and every turkey 

carcass to determine if the carcasses are fit for human consumption. 

In addition, FSIS also ensures facilities are operating in a sanitary environment by verifying that their SSOPs are effective. The 

regulation also requires that the establishment develop, implement 

and maintain written food safety program I mentioned a moment 

ago. Under HACCP, an establishment monitors its processes and 

determines if critical limits are met and, if not, the establishment 

enacts certain corrective action. These actions help ensure the 

53

product safety and prevents an unsafe product from entering commerce. The establishment maintains records of its actions and 

makes all those available to FSIS inspectors. This includes establishment of microbial testing. As part of the HACCP rule, FSIS 

also promulgated pathogen performance standards for each product 

class and conducts its own microbial testing to ensure the establishment is meeting these standards. 

The results of the standards speak for themselves, as previously 

outlined, but virtually all product classes subject to FSIS Salmonella verification testing are at or below half of their respective 

performance standards. If an establishment fails to demonstrate 

that it has produced safe and wholesome products for human consumption, FSIS has the authority to suspend inspection, which virtually shuts the plant down. No meat or poultry plant can ship 

product that has not been afforded the opportunity of inspection, 

therefore, a suspension of inspection is a severe enforcement tool 

that FSIS has. 

In the unfortunate event that unsafe product has been shipped 

into commerce, establishments have historically worked with FSIS 

and voluntarily issued a product recall. Congress, in the 2008 Farm 

Bill, made a significant adjustment to this process, however. Upon 

completion of the new regulations, which FSIS is working on, any 

establishment that has reason to believe adulterated product or 

misbranded products has been shipped into commerce will be required to notify USDA regarding the affected products. Should an 

establishment fail to issue a voluntary recall, FSIS does have the 

legal authority to seize and detain the affected products. However, 

I am not aware of any situation where a meat and poultry plant 

has failed to do so. 

Meat and poultry inspection is truly collaborative and FSIS is in 

the plant continuously. In this relationship the existing enforcement tools of suspension, product seizure, and in severe situations 

criminal penalties, are meaningful and appropriate. Changes to the 

inspection statute is something that does not happen often, and 

should the political will arise to make such a change, Congress 

should focus its energy on writing legislation to ensure the problem 

never arises. HACCP is arguably one of the most advanced, 

science-based food inspection programs in the world and has helped 

ensure the safety of meat and poultry products produced. However, 

it is not perfect, and it didn’t get developed overnight. 

I bring this up only to caution that any such changes to the existing laws or regulations should be done carefully and all due diligence should be exercised. Any changes to the existing statute 

should be done with a scalpel rather than an axe to ensure that 

the current level of inspection is not compromised. As science and 

technology improves, it is highly plausible that the food safety inspection process would and should improve as well. Congress 

should not be so prescriptive that they stifle innovation and prevent modifications to the inspection process that are deemed appropriate. For example, some have called for the law to mandate 

HACCP plans, but what if 15 years from now a new food safety 

program more advanced than HACCP emerges? The Secretary 

would then be limited to either ignoring those advancements or reVerDate 0ct 09 2002 11:26 Oct 02, 2009 Jkt 041481 PO 00000 Frm 00057 Fmt 6633 Sfmt 6601 I:\DOCS\111-10\52575.TXT AGR1 PsN: BRIAN
54

quiring a new system to be used in addition to HACCP. However, 

this does not mean that Congress should not consider changes. 

Currently, FSIS has embarked on further refining its inspection 

process using science, risk, and other appropriate data. The agency 

has been working to utilize risk in determining how to dedicate its 

inspection resources. In today’s economic environment, it is only 

prudent that the government and industry focus its resources towards processes and products that are deemed to be more risky. 

FSIS’ efforts to date offer instructive lessons for anyone interested 

in food safety. All food safety systems should be designed to manage and reduce risk to the food supply. Congress may want to consider giving FSIS expanded authority to allocate inspection resources according to risk, so that the inspectors are focused most 

closely to those tasks which will have the biggest impact on food 

safety. For example, establishment employees could be allowed to 

share bird-by-bird inspection duties, working under and with the 

close supervision of FSIS staff. Such a system would permit inspection resources to be shifted to inspection processes that have a 

measurable public health outcome. 

There have been numerous comments regarding the current performance standards and the effect they have on public health. The 

performance standards have had a notable effect on the incidence 

of pathogens on the products and arguably affected public health. 

Today, the meat and poultry industry as a whole has less than half 

the Salmonella incidence allowed under the standard, so one would 

expect a marked decrease in foodborne illnesses. However, the recent CDC report indicates that we are at a plateau in foodborne illness. Whether this is attributable to issues outside of FSIS is unclear, but it does underscore the need for the next generation of 

performance standards to be developed with appropriate attribution data so that the standards have a measurable public health 

outcome. Thank you, Mr. Chairman. I will answer any questions. 

[The prepared statement of Dr. Rybolt follows:]

PREPARED STATEMENT OF MICHAEL L. RYBOLT, PH.D., DIRECTOR, SCIENTIFIC AND

REGULATORY AFFAIRS, NATIONAL TURKEY FEDERATION, WASHINGTON, D.C. 

Good afternoon Chairman Scott, Ranking Member Neugebauer, and Members of 

the Subcommittee. My name is Dr. Michael Rybolt and I am the Director for Scientific and Regulatory Affairs for the National Turkey Federation, and I staff the 

Federation’s Technical & Regulatory Committee, which oversees all food safety activities for the Federation. NTF, which represents more than 99 percent of the U.S. 

turkey industry, greatly appreciates the opportunity to provide comments today. 

The men and women of the U.S. turkey industry raise more than 260 million turkeys, with an average live weight of 28 pounds per bird. After processing, this yields 

nearly 6 billion pounds of safe, wholesome and nutritious turkey products for American consumers. Food safety is the industry’s top priority and our members agreed, 

years ago, that food safety is an issue on which they would cooperate, not compete. 

Virtually all turkey products purchased in supermarkets are branded—when you 

put your name on the package, you put your reputation on the line. Our members’ 

future success is directly linked to customer confidence in turkey products. 

Federal inspection of turkey and other meat and poultry products has undergone 

a revolution of sorts in the last 13 years, and the collaborative efforts of industry 

and USDA have resulted in some notable accomplishments. Both the government 

and industry have shown they are capable of implementing new food safety programs and a modern, science-based inspection system within the framework of inspection statutes that date back to 1906. Work remains to be done on all sides, as 

we will discuss momentarily, and there could be a role for Congress to play in this 

process. But, the mind set that has been established in both the regulators and the 

55

regulated has created a foundation for the continuing modernization of the meat 

and poultry inspection. 

The turning point was the Pathogen Reduction/Hazard Analysis Critical Control 

Point (HACCP) regulation USDA promulgated in 1996 and began implementing in 

meat and poultry plants in 1998. The HACCP rule recognized that naturally occurring pathogens in raw meat and poultry products had surpassed animal diseases—

the focus of the existing statutes—as the primary public health challenge. It created 

a system by which companies designed food safety plans aimed at identifying the 

points in production where food safety hazards are likely to occur and then devising 

processes to control those hazards. Further, the establishments were required to 

have programs for ensuring they maintain the highest sanitary conditions in their 

facility, Sanitation Standard Operating Procedures (SSOPs). 

HACCP and SSOPs have yielded significant results, as demonstrated by FSIS’ 

pathogen testing data but it is important to understand exactly what inspection 

looks like today under the HACCP system. 

Today, turkey and all other meat and poultry products are produced under the 

daily inspection of USDA’s Food Safety and Inspection Service (FSIS). Current statue requires that FSIS provide continuous bird-by-bird (or carcass by carcass) inspection in order for the mark of inspection to be applied and product distributed in 

commerce. This daily bird-by-bird inspection requires that FSIS inspectors visually 

inspect each and every turkey carcass that is processed and to determine if the carcasses are wholesome and fit for human consumption. This concept dates back to 

the 1906 laws. 

In addition to the carcass inspection, FSIS also ensures that the establishment 

is operating in a sanitary environment, by verifying the SSOPs are effective. Further, the regulations governing the processing of turkey carcasses require that establishments develop, implement and maintain the written food safety program I 

mentioned a moment ago. These last two aspects of inspection are directly attributable to the 1996 HACCP rule. 

Operating under HACCP, an establishment is responsible for its processes and for 

ensuring the safety of the products it produces. HACCP and SSOPs have moved the 

inspection process from the command-and-control system of the past, to a more preventative system for which the establishment is in control, while FSIS ensures compliance with the regulations and the establishment’s own food safety program. 

Under HACCP, an establishment monitors its processes and determines if critical 

limits are met and if not, the establishment enacts certain corrective actions. The 

corrective actions help ensure the products safety and prevent unsafe product from 

entering commerce. The establishment maintains records of its actions and makes 

all the records available to the FSIS inspectors, which includes establishment microbiological testing. 

In the current inspection environment, FSIS doesn’t rely solely on visual carcass 

inspection, plant records or even testing to ensure safe product is being produced. 

As part of the HACCP final rule, FSIS promulgated pathogen performance standards for each product class and conducts product sampling and microbiological testing to ensure that the establishment is meeting these standards. The results of the 

performance standards speak for themselves. Since 1996, the incidence of Salmonella on meat and poultry products has dropped significantly. Virtually all product classes subjected to the FSIS Salmonella verification testing are at or below half 

of their respective performance standards. The turkey industry’s own data, which 

is blinded and complied by NTF, demonstrates that the current incidence of Salmonella on whole turkey carcasses is about six percent, less than half the standard. 

Enforcement 

Under existing law and regulation, if an establishment fails to demonstrate that 

is has produced safe and wholesome products for human consumption, FSIS has the 

authority to suspend inspection, which virtually shuts the plant down. No meat or 

poultry plant can ship product that has not been afforded the opportunity of inspection, therefore a suspension of inspection is a severe enforcement tool that FSIS has 

at its disposal. 

In the unfortunate event that unsafe or unwholesome product has been shipped 

into commerce, a establishments historically have worked with FSIS and voluntarily 

issued a product recall. Congress, in the 2008 Farm Bill, made a significant adjustment to this process. Upon completion of implementing regulations, any establishment that has reason to believe adulterated or misbranded products have been 

shipped into commerce will be required to notify USDA regarding the type, amount, 

origin and destination of the product. Should an establishment fail to issue a voluntary recall, FSIS does have the legal authority to seize and detain the affected 

product. It also has the authority, which it has exercised in the past, to issue a pubVerDate 0ct 09 2002 11:26 Oct 02, 2009 Jkt 041481 PO 00000 Frm 00059 Fmt 6633 Sfmt 6621 I:\DOCS\111-10\52575.TXT AGR1 PsN: BRIAN
56

lic health alert. I am not aware of any situation where a meat or poultry plant has 

failed to issue a recall. In an era where most meat and poultry products are branded, and corporate identities and reputations are tied to the quality of those products, 

the recall and news release remains, perhaps, the most powerful enforcement tool 

of all. 

If Congress considers modernizing the inspection statutes, it must resist the 

temptation to add new enforcement authorities simply for the sake of appearing to 

‘‘be tough.’’ Meat and poultry inspection is truly collaborative, and FSIS is in the 

plant continuously. In this relationship, the existing enforcement tools of inspection 

suspension, product seizure and, in severe instances, criminal penalties are meaningful and appropriate. 

And, has been proven now by Administrations of both parties, news releases, public posting of pathogen testing results and other incentives have led to a dramatic 

enhancement of the food safety system. 

Changing the inspection statutes is something that does not happen often, and 

should the political will arise to make such changes, does Congress want to focus 

its energy on writing legislation to punish companies after a food safety problem has 

occurred, or would it be better to craft legislation that helps ensure a problem never 

arises in the first place? 

Modernization 

HACCP is arguably one of the most advanced, science-based food inspection programs in the world and has helped enhance the safety of the meat and poultry products produced in the United States. However, it is not perfect and did not get developed or implemented overnight. During the implementation period, FSIS hosted numerous public meetings across the country and provided countless supporting documents to help the regulated entities come into compliance with the new requirements. The process was phased-in based on plant size. Today, all federally inspected 

meat and poultry establishments now have a HACCP plan in place. 

I bring this up to only caution that any such changes to the existing laws and 

regulations should be done carefully and all due diligence should be exercised. Any 

changes to the existing statue should be done with a scalpel, not an axe, to ensure 

that the current level of inspection is not compromised. 

When the existing laws were passed, no one knew of HACCP. As science and technology improves, it is highly plausible that the food safety inspection process would 

and should be improved as well. Changes should not be so prescriptive that they 

stifle innovation and prevent the Secretary of Agriculture from making modifications to the inspection process that are deemed appropriate. For example, some have 

called for the law to be amended so that HACCP plans are required by statute. But, 

what if 15 years from now, a food safety program more advanced than HACCP 

emerges? The Secretary by statute would be limited to either ignoring the advance 

or requiring the new system be used in addition to HACCP, creating a needless 

strain on FSIS and company resources. Congress should be careful not to replace 

a 103 year old Act with one that becomes obsolete in 15 or 20 years. 

However, that does not mean that Congress should not consider changes. 

Currently, FSIS has embarked on further refining its inspection process using 

science, risk and other appropriate data. The agency has been working to utilize 

risk in determining how to best utilize its inspection resources. In today’s economic 

environment, it is only prudent that the government and industry focus more of its 

limited resources toward processes and products that are deemed to be more risky, 

from a public health outcome. This clearly is the way of the future—FSIS’ efforts 

to date offers instructive lessons for anyone interested in food safety. All food safety 

systems should be designed to manage and reduce risk to the food supply. Congress 

may want to consider giving FSIS expanded authority to allocate inspection resources according to risk so that inspectors are focused most closely on those tasks 

which will have the biggest impact on food safety. For example, establishment employees could be allowed to share bird-by-bird inspection duties, working with and 

under the close supervision of FSIS staff. Such a system would permit inspection 

resources to be shifted to inspection processes that have a measurable public health 

outcome. 

There have been numerous comments regarding the current performance standards and the affect these have had on public health. Please bear in mind that the 

existing standards were not created because they led to a specific, identifiable public 

health outcome. They were created as a baseline measure of the existing industry 

performance, in 1996, at controlling the incidence of naturally occurring pathogens 

on raw meat and poultry products. The performance standards have had a demonstrable affect on the incidence of pathogens on the products and arguably affected 

public health in the early years of their existence. Today, the meat and poultry inVerDate 0ct 09 2002 11:26 Oct 02, 2009 Jkt 041481 PO 00000 Frm 00060 Fmt 6633 Sfmt 6621 I:\DOCS\111-10\52575.TXT AGR1 PsN: BRIAN
57

dustry as a whole has less than half the pathogen incidence allowable under the 

standards, so one would expect a marked decrease in foodborne illnesses. However, 

the recent CDC report indicates that we are at a ‘‘plateau’’ in foodborne illnesses. 

Whether this is attributable to issues outside FSIS’ and the meat and poultry industry’s control is unclear, but it does underscore the need for the next generation of 

performance standards to be developed with appropriate attribution data so that the 

standards have a measurable public health outcome. 

In closing, it should be reiterated that the U.S. meat and poultry supply is one 

of the safest in the world. However, the turkey industry recognizes changes could 

and should be made to further protect the consuming public. As the food safety reform debate moves to the forefront of the Congressional agenda, any changes that 

are enacted should ensure demonstrable improvements in food safety and that a 

measurable public health outcome is achieved. 

Mr. Chairman and other Members of the Subcommittee, again, let me thank you 

for allowing the National Turkey Federation the opportunity to provide this testimony today. The number one goal of the U.S. turkey industry is to provide safe, 

wholesome, nutritious quality products at an affordable cost to the consumer. All of 

the food safety activities discussed previously have allowed the turkey industry to 

meet its goal. Thank you very much and I will be happy to answer any questions.

The CHAIRMAN. Thank you very much. Mr. Gibber. 

STATEMENT OF ELLIOT P. GIBBER, PRESIDENT, DEB-EL 

FOODS; CHAIRMAN, FURTHER PROCESSORS DIVISION, 

UNITED EGG ASSOCIATION, ELIZABETH, NJ 

Mr. GIBBER. Thank you, Mr. Chairman, and Members of the 

Committee. My name is Elliot Gibber, and I am President of DebEl Food Products in Elizabeth, New Jersey. I also serve as Chairman of the United Egg Association’s Further Processors Division. 

Our members produce liquid, frozen, and dried egg products used 

in the food manufacturing, food service, and retail sector. Of all the 

eggs produced in the United States, about 2⁄3 are sold as shell eggs 

to grocery stores, restaurants, and institutions. The other 1⁄3 of the 

egg supply is used by our egg products industry. As further processors, we are regulated by the Food Safety and Inspection Service 

like the meat and poultry industry. Shell egg producers are regulated by the Food and Drug Administration and USDA’s Agricultural Marketing Service. 

We are proud of producing safe, wholesome, and nutritious products. FSIS maintains a continuous presence in our plants where 

eggs are broken for processing. FSIS regulations mandate that all 

egg products be pasteurized to ensure that pathogens such as Salmonella are eliminated. As a result of these stringent requirements 

since mandatory inspection began in 1970 there has never been an 

outbreak of foodborne illness associated with pasteurized egg products. That is not to say there is never Salmonella present in a pasteurized product. Our own laboratories and USDA do occasionally 

find it, but intensive sampling and test and hold policies allow us 

to keep suspect products from entering commerce or immediately 

stop the distribution. 

We have a good relationship with FSIS and would like to commend the agency for its professionalism and responsibility. I do believe there are few ways that FSIS could do its job even better, and 

would like to mention some of them. First, FSIS should issue a 

HACCP regulation for the egg products industry. FSIS has sole responsibility for our industry since 1995, and has long since implemented HACCP regulations for meat and poultry, but not for egg 

products. We understand the proposed rule is virtually complete. 

58

We hope the Committee will urge FSIS to move ahead. A HACCP 

regulation will permit more flexibility while giving our industry additional responsibility to ensure safe product. 

Second, FSIS needs to apply inspection requirements in a rational manner. In response to meat and poultry issues that were raised 

last year by another Congressional Committee, FSIS has recently 

decided to increase inspection of egg product plants that are already being inspected 8 to 16 hours a day. The additional inspection will be costly to us and to taxpayers. If it would result in food 

safety benefit the added cost would be worth it, but, in fact, the additional inspection is not for potential hazardous operations like 

breaking eggs. Inspectors have always been present when that occurs and always should be. Now FSIS has plans to have an inspector literally sit and watch a few containers per hour being filled 

with dry egg whites even though the product was inspected previously, and cannot be shipped to a customer until it is inspected 

again. 

One of our customers told us they may incur 100 hours or more 

of overtime each week so an inspector can continuously observe the 

sealed room where dry egg products is heat treated for at least 7 

days. I hope this inspector brings plenty of reading material. Clearly, this is an over reaction and is not the best deployment of our 

resources. An inspector who sits and watches a sealed room for 7 

days is not available for other infinitely more important food safety 

work. We hope you will encourage FSIS to rethink these policies. 

A third area of improvement for FSIS lies in the way it makes policy. We have seen official directives which do not go through public 

comment procedures. Whether the policies are significant or not, 

they should have been issued as proposed regulations. 

Even when the use of a less formal directive is justified, we have 

seen the failure to consult with industry in advance that has sometimes led to ill-considered policies. A little advanced consultation 

with us, and, yes, with the consumers and the public too, would 

pay dividends and make better policies. Let me conclude with two 

broad policy areas where we believe FSIS’ current systems is appropriate and should be maintained. First, we support the laws and 

regulations that require that egg products only be imported from 

countries with food safety systems equivalent to ours. Second, we 

believe that FSIS is appropriately housed in the Department of Agriculture. We do not support moving FSIS to a different cabinet Department. 

The expertise, institutional memory, and experience within 

USDA, and within this Committee, should not be lightly discarded. 

Our group has not taken a formal position for or against a single 

food safety agency, but we do not want to see any change that 

would deprive this Committee of its jurisdiction, or disrupt the food 

safety functions that FSIS generally carries out very well. Thank 

you for the opportunity to testify. I will be glad to answer your 

questions at the appropriate time. 

[The prepared statement of Mr. Gibber follows:]

59

PREPARED STATEMENT OF ELLIOT P. GIBBER, PRESIDENT, DEB-EL FOODS; CHAIRMAN, 

FURTHER PROCESSORS DIVISION, UNITED EGG ASSOCIATION, ELIZABETH, NJ 

Good morning Mr. Chairman, Mr. Neugebauer and Members of the Subcommittee. My name is Elliot Gibber and I am the President of Deb-El Foods, in 

Elizabeth, New Jersey. We are a mid-sized egg products operation and employ 160 

people in New Jersey and New York. 

I appreciate the opportunity to testify on behalf of United Egg Association 

(UEA)—Further Processors Division. UEA members produce about 80% of all the 

liquid, frozen and dried egg products in the United States. UEA is a trade association whose activities include efforts to assure the continued safety of the foods we 

produce for U.S. and foreign consumers. 

Food Safety in the Egg Products Industry 

I thank the Subcommittee for holding a hearing on the safety of egg products, red 

meat and poultry produced in the United States. The several reported incidents of 

contamination in both domestic and imported foods over the last few years have legitimately raised concerns in the Congress and with consumers and the food industry itself. 

I would like to begin with two significant points about regulation of the egg industry in this country. First, unlike most other food produced here, the Food and Drug 

Administration (FDA) and the United States Department of Agriculture (USDA) 

share responsibility for the safety of shell eggs. On the other hand, USDA alone regulates the processing of liquid, frozen and dried egg products through the Food Safety and Inspection Service (FSIS). Second, unlike many other agricultural commodities, USDA regulations mandate pasteurization of all processed egg products in compliance with prescribed protocols to assure the destruction of pathogens. 

The egg products industry uses almost 1⁄3 of the shell eggs produced by U.S. egg 

farms. We produce the various egg products that are used in food service, institutions and food manufacturing. Our presence in the retail sector is growing. Our industry, working with government, has made gigantic strides in improving the safety 

of our products. These improvements began some 4 decades ago. 

Until the last quarter of the 20th century, our businesses primarily processed surplus table egg production and those qualities of eggs that were unsuitable for table 

use. Then, the demand for egg products began growing at a pace faster than traditional shell egg production. At the same time, we recognized the demand from our 

customers for consistent high-quality products and greater consumer expectations of 

safe foods. Today, the majority of eggs used in our industry come from egg-laying 

flocks dedicated to egg products production. In fact, over half of the eggs used in 

egg products move directly from the hen house to the processing plant where they 

are broken and processed the same day they are laid. 

Our industry was concerned with food safety long before it became the issue it 

is today. In the 1940s the USDA and industry worked together to create a voluntary 

egg products inspection program. It was under that program that industry and the 

Agricultural Research Service developed reliable methods for pasteurization of egg 

products and in 1965, USDA began requiring pasteurization as part of their voluntary inspection program. 

Mandatory Egg Products Inspection 

By 1970, about 75% of the egg products produced in the United States were under 

continuous USDA inspection. That same year, Congress enacted the Egg Products 

Inspection Act, which required continuous inspection of all egg products manufacturing. The majority of our industry strongly supported that legislation and worked 

with Congress to develop the necessary legislative language. Among other things, 

the Act has resulted in legal requirements that all egg products processed in the 

United States undergo pasteurization. 

Our Food Safety Record 

Before implementation of mandatory inspection in 1971, foodborne illnesses were 

sometimes associated with consumption of liquid, frozen and dried egg products. 

Salmonella was and remains the pathogen of primary concern in our industry. Since 

1971, we are not aware of a single outbreak of salmonellosis in humans attributed 

to pasteurized egg products. That is a claim that few industries can make. 

That is not to say that Salmonella is never present in a pasteurized egg product. 

Our laboratories and USDA laboratories infrequently find Salmonella in a sample 

of tested product. However, intensive sampling coupled with company test-and-hold 

policies for many of our products prevent suspect products from entering marketing 

channels and/or result in immediate action to stop their distribution. 

60

Imports 

As is the case for red meat and poultry, only egg products produced in a foreign 

country maintaining an inspection system equivalent to ours may be imported into 

this country. I believe that it is indicative of the strength of our system that only 

one country—Canada—currently meets this high standard. Over the years, some 

countries have tried, without success, to achieve equivalency. Many others have 

dropped the idea after learning what they must do to meet our high safety standard. 

Much to the chagrin of our industry, in at least one instance, USDA took the position that an interested foreign country did not need to bring all of its facilities up 

to our standard. That is, the country was told it could export products to the U.S. 

if it could get even one plant approved. After years of trying, the potential exporting 

country has yet to receive USDA approval of a single plant. 

We do have concerns over imported food and feed ingredients that we need. Certain feed ingredients are only available from countries such as China. Some of the 

minor ingredients used in our egg products are only commercially available from 

other countries. Our industry is not comprised of multi-national corporations that 

can afford a presence in these supplying countries. Like just about all other consumers in the United States, we depend on the Federal Government to help assure 

the safety of imported consumer goods. While this Subcommittee’s jurisdiction may 

be limited in this area, I urge the Congress to take swift and effective action to improve our import inspection programs and give greater scrutiny to imported food. 

Single Food Safety Agency 

United Egg Association has not taken a position on a single food safety agency 

as some members of the Administration and Congress have suggested. We do, however, have several concerns over the practicality of these proposals. The obvious example of the Department of Homeland Security does provide a lesson in how things 

can go wrong when reorganizing government. As you are aware, that reorganization 

resulted in a loss of institutional knowledge previously available to agriculture and 

a lessened priority for agriculture issues. 

In 1995, a Congressionally mandated reorganization of food safety activities at 

USDA resulted in the Department moving the egg products inspection program from 

the Agricultural Marketing Service to the Food Safety and Inspection Service. This 

move placed all major food safety functions at USDA into one agency. Yet, this relatively non-complicated move with one Department of the Federal Government created challenges that still exist, at least in part, today. Certain efficiencies were lost, 

institutional knowledge was lost forever, chains of command were confused, and 

mid-level employees became unsure of their responsibilities. In this instance, the bureaucracy of a vastly larger program swallowed a relatively small program. 

We cannot support any restructuring of food safety responsibilities that would reduce the jurisdiction of this Committee. Mr. Chairman, your Committee represents 

the critical experience, understanding and institutional knowledge of agriculture, 

and, more specifically, food safety programs for egg products, red meat and poultry. 

My intent here is not to flatter the Subcommittee Members. Our experience dictates 

that we speak up on this issue now or suffer the consequences later. 

HACCP 

I would like to ask the Subcommittee to encourage USDA to proceed with plans 

to implement a mandatory Hazard Analysis and Critical Control Point (HACCP) 

program for egg products. The Department implemented these programs for red 

meat and poultry more than a decade ago. The previously referenced move of the 

egg products inspection program and subsequent higher priorities for FSIS have delayed publication of a proposed egg products HACCP rule. But after nearly 15 years, 

it does not seem unreasonable to ask that FSIS publish a proposed rule for public 

comment. 

As opposed to the current, outdated ‘‘command-and-control’’ regulatory structure, 

our membership has long recognized the need for HACCP programs to better assure 

the safety of our products. Accordingly, our members have implemented these programs based on the best information, training and professional support available, 

but without regulatory guidance from USDA. 

These HACCP programs meet our customers’ expectations and we believe that 

they will meet any standard set by USDA. However, the lack of a HACCP-based 

inspection program has resulted in an unnecessarily complicated regulatory burden 

on our companies. To a lesser but important extent, we are concerned that our trading partners can use lack of a national HACCP program for egg products as one 

more non-tariff trade barrier. 

We also recognize that compliance with an eventual USDA program will inevitably require some changes in our existing voluntary programs. The longer mandaVerDate 0ct 09 2002 11:26 Oct 02, 2009 Jkt 041481 PO 00000 Frm 00064 Fmt 6633 Sfmt 6621 I:\DOCS\111-10\52575.TXT AGR1 PsN: BRIAN
61

tory HACCP is delayed the greater likelihood of changes being required along with 

the associated costs of such changes. 

HACCP is recognized as the ‘‘gold standard’’ for food safety. We believe it will result in an even safer food supply and ask the Committee’s help in encouraging FSIS 

to move quickly on a HACCP regulation. 

Engage With FSIS 

FSIS uses a system of official directives to communicate new or revised policy to 

the regulated industry and the agency’s inspection staff. Over the last few years, 

this system has too frequently worked as rule-making without an opportunity for 

comment. These directives can carry changes in policy to improve or better assure 

the safety of products regulated by FSIS. Unfortunately, such policy making sometimes occurs in a vacuum without an opportunity for input from the industry. 

The agency has invited us to comment on directives after they are finalized, but 

as a matter of departmental policy does not seek comment in the formulation stage. 

This has resulted in policy that is based on limited information or perhaps without 

full understanding of industry practices. We believe that for the best and most efficient food safety program, the regulatory agency needs to engage the industry in 

policymaking. Some contemplated policies need to be discussed through rule-making 

where consumer advocates, industry and other interested parties all have a chance 

to comment. 

I respectfully request that the Subcommittee ask USDA to seek input from industry and, when appropriate, other interested parties as the Department considers 

policy changes. 

Expanded Inspection Coverage 

Last year, during a hearing conducted by another House Committee, FSIS was 

criticized for the limited inspection coverage it was providing to certain red meat 

and poultry further processing operations that do not involve slaughter. In responding to that criticism, the agency increased the frequency of inspections at these ‘‘patrol plants,’’ some of which were being inspected less frequently than weekly. 

In further response to that oversight hearing, the agency recently decided to increase inspection in egg products further processing operations that were already receiving inspection a minimum of 8 hours and often 16 hours or more during at least 

5 days of each week. We estimate that this expansion will require that the agency 

hire an additional 30 or more inspectors to regulate an industry that consists of less 

than 80 processing plants. 

In many instances, the cost of this additional coverage will be charged to our 

members as overtime and in other cases, taxpayers will bear the burden. In just 

about every instance, there is no food safety justification for the additional coverage. 

Plants have never been able to perform critical functions such as egg breaking—

which is somewhat analogous to slaughter—without an inspector on duty. Other 

processes could continue on a limited basis after the end of an inspector’s tour of 

duty with the understanding the process was always subject to an unannounced surveillance inspection. 

Some egg driers produce only a few hundred pounds of product each hour. Now 

even plants where that is the only process occurring on third shifts or on weekends 

will pay for an inspector to literally sit and watch a few containers being filled each 

hour. The only human intervention in these operations is to close a filled box or 

drum and replace it with an empty container. Keep in mind that the product going 

into those containers was produced from previously inspected liquid product and the 

final product cannot be shipped until the inspector has an opportunity to inspect 

it. 

In the worst example I have heard to date, one company was told that they could 

incur 100 or more hours of overtime each week so that an inspector can continuously observe a sealed room where dried product is heat-treated for at least 7 days. 

I hope that inspector likes to read. If the Subcommittee had a lot of time, I could 

offer other similar examples. 

The Department has, after almost 38 years of operating a highly successful inspection program, found a legal technicality that their attorneys believe justifies this 

expansion of inspection coverage. Perhaps they can use legal language to justify imposing this additional burden on the regulated industry and taxpayers. 

However, it makes no sense from a food safety or practical standpoint. It did not 

make sense 38 years ago, and certainly does not make sense now, particularly considering our food safety record and the many improvements in automated process 

control. At a time when FDA is inspecting some very complex food processing operations once every 10 years, we believe that the Subcommittee may want to consider 

if USDA is making the best use of resources. 

62

Conclusion 

Mr. Chairman, I appreciate the strong interest of Members of this Subcommittee 

in improved safety of our food supply. Every person in our nation should be interested in improved food safety. At the same time, I appreciate the opportunity to explain the measures already in place that continue to assure that the United States 

has the safest egg products in the world. 

Thank you, Mr. Chairman.

The CHAIRMAN. Thank you. Mr. Carpenter. 

STATEMENT OF BARRY L. CARPENTER, CEO, NATIONAL MEAT 

ASSOCIATION, OAKLAND, CA 

Mr. CARPENTER. Chairman Scott, Ranking Member Neugebauer, 

Members of the Subcommittee, thank you for the opportunity to 

testify. The National Meat Association has over 500 members, and 

has served the interests of the meat packing industry since 1946. 

Our members are committed to safe food and high quality production. NMA provides regulatory and technical assistance as well as 

Pathogen Reduction and HACCP support and education to our 

members. We provide a network for all segments of the industry 

to come together through workshops, conferences, and ad hoc meetings. While NMA represents establishments of all sizes, my testimony will focus on small plants. Approximately 25 percent of our 

general members are federally inspected facilities with less than 20 

employees. My prepared testimony discusses the evolution of 

HACCP implementation for small establishments, and the FSIS 

and industry outreach for those plants. 

For my oral testimony, I will discuss what I see as strengths of 

FSIS in this area, as well as those areas where I see a need for 

improvement. NMA believes that overall FSIS has done a good job 

protecting public health given the outdated nature of the statute 

under which it operates. The agency has implemented HACCP and 

conducted routine verification testing in all establishments where 

they have oversight. Being able to successfully implement these 

programs in all establishments whether they employ 500 employees or one employee was not an easy task. 

FSIS has conducted significant outreach and has allowed the outreach to evolve as the industry’s needs have changed from implementation to design. When NMA and others have called on FSIS 

to partner on outreach needs, FSIS has responded promptly. FSIS 

used to provide information through hard copy materials but now 

uses hands-on workshops, web-casts, podcasts, and even Twitter. 

Not all establishments have successfully implemented well-designed HACCP plans and FSIS has instituted a solid infrastructure 

to continuously support those establishments, especially to continue to evolve in a more risk-based system with measurable public 

health outcomes. FSIS already conducts the majority of its pathogen sampling in a risk-based fashion based on sampling data it has 

collected over time. 

We encourage FSIS to continue to strengthen the quality of the 

data it collects so that it can base more of its inspection activities 

and policies on this data; continue towards a risk-based system, including reassignment of inspection resources and inspection tasks. 

FSIS has demonstrated successes over the last several years with 

a risk-based approach as the foundation, and these successes could 

be a model for the entire food safety system. Food safety should be 

63

less about which agency is inspecting the food and more about the 

risk profiles posed by different food products, and the performance 

of the establishments that manufacture those food products. 

We also believe that any proposed changes should be sustainable 

well into the future. I refer here to the example of HACCP and the 

evolution of small plant outreach programs. We encourage you to 

avoid making any legislative changes so prescriptive that evolution 

cannot occur within a regulatory context. We believe that continuous training is essential for FSIS employees, and while significant 

improvements have been made in this area, we believe this is an 

area in which FSIS cannot rest on its laurels. For continuous 

progress to occur, the agency’s commitment to training must be 

sustained. As the processes and techniques for effective food safety 

assistance evolve and become more sophisticated the need for consistent implementation will be paramount. 

Finally, I will close with a thought on communications. We 

strongly encourage the agency to communicate with all constituents during the early stages of policy development. If stakeholders 

can be included in the process from the beginning, then all stakeholders benefit. New policies must consider the realities of production and add value to the overall food safety initiative. Further, 

interactive implementation in small phases would be a huge benefit, especially to the small and very small plants. 

In summary, FSIS has done a good job with the small and very 

small plant outreach program. This has allowed successful implementation of HACCP. Most notably, the agency has allowed the 

program to evolve when the needs of the establishments evolve. 

Moving forward, we are hopeful that any future changes be evolutionary in nature, risk-based with measurable public health outcomes as their focus. NMA believes that through our collective efforts the small and very small plants can continue to be an integral 

part of a safe and plentiful food supply. I am pleased to answer any 

questions. 

[The prepared statement of Mr. Carpenter follows:]

PREPARED STATEMENT OF BARRY L. CARPENTER, CEO, NATIONAL MEAT

ASSOCIATION, OAKLAND, CA 

Introduction 

Chairman Scott, Ranking Member Neugebauer, and Members of the Subcommittee, I am Barry Carpenter, Chief Executive Officer of the National Meat Association (NMA), headquartered in Oakland, California. NMA has over 500 members, and has served the interests of the meat packing industry since 1946. Our 

members are committed to safe food, high-quality production, and most remarkably 

to each other. NMA provides regulatory and technical assistance as well as Pathogen Reduction (PR) and Hazard Analysis Critical Control Point (HACCP) support 

and education to our members. Consultants tap into our networking resources; and 

academics and educators utilize our information services and weekly newsletter and 

website. We provide a network for all segments of the industry to come together 

through our offices, (in California and Washington), workshops, conferences, conventions, and ad hoc meetings. 

While NMA represents establishments of all sizes, as well as equipment manufacturers, consultants, educators, and others, my testimony will focus on small plants. 

Approximately 25 percent of our general members are federally inspected facilities 

with less than 20 employees. We recognize that there are many issues regarding 

food safety right now, and believe that is why it is important for there to be such 

a diverse panel of experts testifying today. I will discuss the evolution of PR/HACCP 

implementation for small establishments, the Food Safety and Inspection Service 

(FSIS) outreach for small and very small plants, and industry outreach. Finally, I 

64

will discuss what I see as strengths of FSIS in this area, as well as those areas 

where I see a need for improvement. I will be happy to answer questions on this 

topic, as well as more broad scale questions at the conclusion of my testimony. 

Implementation of PR/HACCP 

FSIS published the final rule for PR/HACCP Rule in 1996. In January 1997 all 

establishments, regardless of size were required to implement Sanitation Standard 

Operating Procedures (SSOPs). However, FSIS recognized that HACCP implementation would be more difficult for small plants and provided a phased implementation 

process. FSIS utilized the definition of the Small Business Administration when 

considering plant size. That is, they considered:

Large: 500 or more employees.

Small: 10–499 employees, unless annual sales total less than $2.5 million.

Very small: Fewer than ten employees, or annual sales of less than $2.5 million.

Further, to meet the requirements of the Small Business Regulatory Enforcement 

Act of 1996, FSIS implemented the Small and Very Small Plant Outreach Program, 

specifically tailored to these plants. FSIS focused on ensuring that these establishments had the resources that were needed to successfully implement a HACCP 

plan. Generic HACCP plans were provided, workshops were presented, and materials were provided to these facilities including examples of how to implement a 

HACCP plan that met the basic regulatory requirements. FSIS established a 

HACCP Hotline at the Technical Service Center in Omaha, NE to respond to 

HACCP technical and implementation questions from industry and FSIS personnel. 

The Hotline doubled the number of staff to ‘‘gear up’’ for implementation at small 

establishments, as they had received over 16,000 calls during the first year when 

large establishments had implemented HACCP. The hours of operation were consistent with the needs of both coasts, and 24 hour coverage was available. NMA 

members often asked our staff to join them on these calls to ensure they understood 

the responses and could best utilize the information they were provided. Additionally, FSIS conducted 20 nationwide meetings in preparation for the small plant implementation—hosting over 1,700 participants. It was these types of activities, and 

the commitment of the industry taking advantage of the FSIS resources, that led 

to successful implementation of HACCP by all segments of the industry, both 

large and small. It is important to note that virtually none of the small and very 

small plants had employees with experience or training in process controls or 

HACCP principles. This transition was very frightening and traumatic for plant 

owners and their employees. A major factor leading to the successful implementation of HACCP was the constructive interaction among FSIS, NMA and our members. 

Evolution of FSIS’ Outreach 

Once everyone had implemented HACCP, FSIS established a new position, the 

Enforcement and Investigation Analysis Officer to review the actual design of the 

HACCP plan. It was at this point, that FSIS recognized the needs of the small and 

very small plants had evolved. While small plants had implemented HACCP, those 

plans were not all well validated or well designed food safety systems. So in 2005, 

FSIS worked with small and very small plant operators to reassess their HACCP 

plans and enhance the design of their food safety systems. NMA and our members 

participated in outreach sessions held by FSIS in Montana, Pennsylvania, Massachusetts, and California. These sessions produced a healthy dialogue about what updates FSIS needed in their outreach strategy. The feedback suggested FSIS needed 

to gear the outreach toward the scientific basis for the HACCP plan; shifting the 

focus from the execution to the design of the plans. Further, the International 

HACCP Alliance, of which NMA is a charter member, hosted a strategic meeting 

in December 2005, to assist FSIS in determining the needs of small and very small 

plants and how best to meet those needs. In response to this meeting FSIS developed an Implementation Plan for all eight of its Program Areas to take actions to 

meet the most current needs of the small and very small plants. 

FSIS has since established a stand alone outreach office focused on this effort, the 

Office of Outreach, Employee Education and Training. FSIS has moved to conducting Regulatory Education Sessions, the closest the agency has come to joint 

training, by allowing both agency and industry personnel to participate. The agency 

has developed several podcasts on key issues, and has begun issuing a Small Plant 

Newsletter on important topics. Most recently the agency has begun ‘‘hands-on’’ 

workshops for small and very small plants. 

65

NMA Outreach 

On many occasions, the National Meat Association has partnered with FSIS to 

meet the needs of its members with small and very small establishments. Further, 

based on the premise that food safety should not be a competitive issue in the industry, NMA has included many of our large establishment representatives to assist 

with these type programs. I will point out a few examples of current programs NMA 

has hosted in which FSIS has very willingly participated.

• Humane Conference Call—agency representatives, NMA, academia, industry 

consultants—June 2008.

• Humane Handling Conference Call—with agency representative, NMA and industry consultants—March 2008.

• Export Verification—agency representatives, NMA, academia, industry consultants—June 2008.

• E. coli Notices—NMA, agency representatives, academia, industry consultants—

October 2007. 

What FSIS has Done Well 

NMA believes that overall FSIS has done a remarkable job protecting public 

health, given the outdated nature of the statutes under which it is operating. The 

agency has implemented SSOPs, HACCP and conducted routine verification testing 

in all establishments for which they have oversight. Being able to successfully implement these programs in all establishments, whether they employ 500 employees 

or one employee was not an easy task. FSIS has conducted significant outreach, and 

has allowed the outreach to evolve as the industries needs evolved. As the industry 

needs have changed from those of implementation to design, FSIS resources followed suit. When NMA (and others) have called upon FSIS to partner in outreach 

needs, FSIS has responded promptly. As the resources that people need change, so 

has FSIS. FSIS used to rely primarily on the telephone and hard copy materials, 

but now uses, hands-on workshops, web-casts, podcasts, and even Twitter. 

What Can Be Improved? 

Now that all establishments have successfully implemented well-designed HACCP 

plans, and FSIS has instituted a solid infrastructure to continuously support those 

establishments, inspection should continue to evolve to a more risk-based system 

with measurable public health outcomes. FSIS already conducts the majority of its 

pathogen sampling in a risk-based fashion, based on sampling data it has collected 

over time. We encourage FSIS to continue to strengthen the quality of data it collects so that it can base more of its inspection activities and policies on this data 

and continue to move more fully towards a risk-based system, including reassignment of inspection resources and inspection tasks. FSIS has demonstrated successes 

over the last several years with a risk-based approach as the foundation, and these 

successes could be a model for the entire food safety system. Food safety should be 

less about which agency is inspecting the food, and more about the risk profiles 

posed by different food products, and the performance of the establishments that 

manufacture those food products. 

We also believe that any proposed changes should be such that they can be sustained well into the future. I refer here to the example of PR/HACCP and the evolution of the small plant outreach program. We would encourage you to not make 

any legislative changes so prescriptive that evolution cannot occur within a regulatory context. 

We believe that continuous training is essential for FSIS employees. And while 

significant improvements have been made in this area, we believe this is an area 

in which FSIS cannot rest on its laurels. For continuous progress to occur the agency’s commitment to training must be sustained. As the processes and techniques for 

effective food safety systems evolve and become more sophisticated the need for consistent implementation will be paramount. 

Finally, I would close with a thought on communications. We would encourage the 

agency to communicate with all constituents during the developmental phase of policy development. Once a policy is developed it is too late. If stakeholders can be 

brought in early in the process, then all stakeholders benefit, including the agency. 

New policies must consider the realities of production and add value to the overall 

food safety initiative. Further, interactive implementation would be a huge benefit, 

especially to the small and very small plants. We would encourage open communication at all stages throughout the process of policy development. And interactive implementation in small phases so that everyone understands each step before moving 

on to the next. 

66

Summary 

In summary, FSIS has done a remarkable job with their small and very small 

plant outreach program. This has allowed successful implementation of PR/HACCP, 

a preventive system for the reduction of food safety issues in meat and poultry 

plants. Most notably, the agency has allowed the program to evolve with the needs 

of these establishments. Moving forward, we are hopeful that any future changes 

are also evolutionary in nature, risk-based with measurable public health outcomes 

as their focus. NMA believes through our collective efforts the small and very small 

plants can continue to be an integral part a safe, efficient and plentiful meat supply. 

I now will be happy to answer any questions.

The CHAIRMAN. Thank you very much, and thank each of you for 

your testimony. They have been very, very informative and will go 

a long way in helping us. We in Congress, and this Administration, 

are determined, of course, to keep our food safe for our country and 

the world. Certainly, we cannot do it without you, and we are 

grateful for your time and for the testimony that you have given. 

We will now open it up for questions. I have a few. Let me start, 

first of all, with Dr. Krushinskie, if I may. Something you said really grabbed me and I wanted to make sure that it was accurate. You 

gave a data, a piece of data, that referred to the amount of chicken 

that we consume individually. Would you repeat that? How much 

chicken does each person in the United States consume? 

Dr. KRUSHINSKIE. In 2008, Mr. Chairman, the per capita consumption of chicken is 85 pounds, the number one meat. 

The CHAIRMAN. Each person consumes 85 pounds of chicken. 

Dr. KRUSHINSKIE. Per year. 

The CHAIRMAN. That is great, especially for my State of Georgia. 

As you know, we are the poultry capital of the world. Let me ask 

you just a couple of questions, if I can, about the poultry. Can you 

explain what sanitation standard operating procedures SSOPs and 

pathogen reduction performance standards for Salmonella are and 

how they differ from HACCP? 

Dr. KRUSHINSKIE. All right. We have several regulations that are 

in the Title 9 Code of Federal Regulations. One is section 417, 

which addresses HACCP regulations, which details how analyses 

are established, process flow is identified, and the corrective actions and preventive measures that are taken if there are deficiencies. Regulation 416 address sanitation, the sanitary operating 

procedures, SOPs, and the sanitation standard operating procedures are SSOPs. Those are broken into two categories. One consists of the facility, also, the walls, the floors, the integrity of the 

roof, things like that, potable water, et cetera, and the other would 

be operational sanitation so that is keeping product clean, keeping 

it off the floor, not piling up on equipment, et cetera, or employee 

hygiene, hand washing, hair nets. 

We have what we consider to be good manufacturing practices 

which address jewelry, employee hygiene, hand washing, wearing 

smocks, all that kind of—all the parameters that produce a clean 

operating environment. 

The CHAIRMAN. And how does FSIS verify that a poultry plant 

is following its HACCP and SSOPs and pathogen reduction performance standards for Salmonella? 

Dr. KRUSHINSKIE. All right. We have, as you know, we have both 

a veterinarian, typically inspector in charge, or IIC, on each operating shift plus a number of inspectors that work for them, and 

67

part of their inspection responsibility is the individual inspection of 

carcasses going down the line. But an additional responsibility is 

to do two things, to verify that we are operating according to the 

plans that we have written so we are doing what we say we are 

going to do. They come and visually observe that we are either taking checks, that we are handling product appropriately, that we are 

not piling up meat on the floor, et cetera. They also verify our 

records, and they do a record review periodically, actually very frequently, but it is assigned by a computer-generated system so they 

will perhaps look at certain aspects each day. By the end of some 

window of time they have evaluated all the records. 

The CHAIRMAN. If this process is sufficient in doing the job, no 

changes need be made? 

Dr. KRUSHINSKIE. I think it is sufficient. I think that actually we 

believe that we probably are overly regulated or not so much really 

regulated, but having inspectors on-site 24 hours while you are 

processing is probably a little bit excessive. We take a lot of pride 

and responsibility for devising these operating programs, process 

control programs, as well as sanitation programs, implementing 

them and monitoring them ourselves, so we take a lot of that responsibility. I am not sure that today it is necessary to have USDA 

inspection in the plant at all times. 

The CHAIRMAN. I see. Now the beef industry has what is known 

as Beef Checkoff funds, and does the poultry industry have something similar to the Beef Checkoff funds? They don’t? 

Dr. KRUSHINSKIE. No, we do not. We support a couple of different 

trade associations, National Chicken Council, National Turkey Federation, and U.S. Poultry and Egg Association are the three primary associations, and those are all through voluntary dues. 

The CHAIRMAN. Okay. Well, thank you. I will now turn to the 

Ranking Member, Mr. Neugebauer. 

Mr. NEUGEBAUER. Thank you, Mr. Chairman. Mr. Boyle, would 

you kind of highlight the differences between USDA food inspection 

and FDA food inspection, and kind of talk about the differences? 

Mr. BOYLE. They are quite substantial. One of the graphics that 

I put up during my testimony summarized the differences between 

FSIS and FDA. Off the top of my head, FSIS is responsible for 

about 6,200 plants. They have about 8,000 inspectors to provide 

that service. FDA conversely is responsible for about 136,000 facilities. I believe they have 1,900 staff. A lesser amount of them would 

be field inspectors. And the budget disparities are the reason that 

the inspection intensities are so disparate as well. FSIS is appropriated about $1.1 billion a year, FDA, about $650 million. 

One of the other major differences is that for our plants that are 

slaughtering animals that inspection presence is continuous. If the 

inspector is late, we don’t start on time. And it is somewhat of a 

misnomer or misleading to say there is an inspector on-site when 

we are slaughtering animals and processing meat and poultry. Depending upon the size of the plant, the volume of product that is 

produced therein, the number of inspectors could rise to as many 

as a dozen per shift, so it is not just a inspector in these large high 

volume plants. There are multiple inspectors stationed throughout 

the facilities during our hours of operation. 

68

Mr. NEUGEBAUER. Well, I am glad you—and I would like to leave 

that chart up because when that popped up, I was a little bit 

shocked at the disparity of allocation of resources where FDA is obviously looking at multiple times more facilities with fewer people 

and less resources. Should that concern us? 

Mr. BOYLE. Well, we are relatively satisfied with the level of 

oversight that we have under FSIS. As I mentioned in my testimony, the core reform in the last 15 years has been the mandate 

that HACCP programs be incorporated into our plants. It was the 

American Meat Institute that petitioned USDA to impose that 

mandate, because our member companies had discovered on their 

own that HACCP was the most effective way to ensure the integrity of the process and the safety of the product. 

I would note that many of the bills that have been introduced in 

this Congress to reform FDA oversight, their sector of the food industry, a common component in all of those proposals is a HACCP 

like mandate. 

Mr. NEUGEBAUER. And maybe Dr. Reagan has referred to this as 

well, but it appears from what I hear you all say the HACCP program kind of revolutionized the industry to a great degree, and 

that a great deal of improvement in the results of food safety occurred by the implementation of that. Is that correct? 

Mr. BOYLE. I think it is a fair observation to say that it took our 

process controls to a new level. The pathogen incidence data I cited 

from FSIS will show that the incidence is lower for E. coli and Listeria and Salmonellas as well, but more importantly the foodborne 

illnesses associated with at least E. coli and Listeria have decreased over the last 9 years. It is not true with Salmonella even 

though our incidents in the plants have gone down dramatically. 

Mr. NEUGEBAUER. So if I am reading that right, and if we were 

kind of looking at how we best distribute our assets, one, maybe 

you or Dr. Reagan said, we can’t test our way to safety here, that 

we have to kind of look at the process and look at the technology, 

I guess, new technologies and new science. So, are we better off investing more of our resources in the process of how the product is 

brought into and through the process. The testing obviously is a 

random way to determine how well we are monitoring the front 

end. Am I headed in the right direction on that? 

Mr. BOYLE. I think you are absolutely correct, Congressman. I 

will give you an example that involves controlling Listeria in our 

ready-to-eat meat and poultry products. About 7 years ago, FSIS 

proposed a new Listeria control regulation that categorizes readyto-eat products into three categories. The first are the plants that 

have the Listeria testing and sampling control programs in place. 

All plants had to do that under the regulations. But if a plant also 

has a secondary intervention to control Listeria, such as using certain ingredients that inhibit the growth of Listeria in the formulation of the products, that is a plant in a different category that has 

greater controls for Listeria. And there is a third category, some plants have actually invested 

in high pressure pasteurization post packaging, so there are three 

hurdles in that operation to reduce and control Listeria, and the 

agency is then able to allocate its inspection resources based upon 

the relative risk, not high risk, Mr. Chairman, but the relative risk 

69

of the products in those various plants, and the result has been 

very successful. We have not had a Listeria-related foodborne illness recall since 2003. 

Mr. NEUGEBAUER. Thank you, Mr. Chairman. 

The CHAIRMAN. The gentleman from Idaho, Mr. Minnick. 

Mr. MINNICK. Mr. Chairman, members of the panel, my bias is 

that between the trial lawyers bar and the appetite of media for 

anything sensational that 98 percent, at least, of the producing entities—all but the fly by night or here and there, here today and 

gone tomorrow—have plenty of incentive to self inspect to standards that ensure that there is almost no possibility of a serious incident reaching the retail consumer. What I would like to ask each 

of the heads of the processing organizations represented here is 

what is the one thing that the FSIS could do, or not do, or modify 

that would most improve the cost effectiveness of your self inspection programs? 

Mr. BOYLE. Congressman, I just cited what would be my example, the development of regulation in that case, Listeria control for 

ready-to-eat products that recognizes relative risk, recognizes multiple interventions of different ways to control and ensure the absence of Listeria in the product. It incentivizes industry to go the 

extra mile, if you will, in exchange for a little bit of regulatory relief allowing the agency to focus on relatively higher risk products. 

More regulations crafted along those lines would be very positive. 

Mr. MINNICK. I appreciate that very much, sir. I am interested 

in what the producers, whether they agree with you or whether 

they think there is something else that you could do, or not do, that 

would improve the cost effectiveness of their self-regulatory procedures. 

Dr. REAGAN. I think what we can do there, one of the concerns 

that we have, and I mentioned it in my testimony, was that as we 

look at inspection, one of the most critical things that we have 

there is having everybody educated. As we are looking at best practices whether you have FSIS there or whether you have your own 

plant people there that are overlooking that, it is very important 

that those people are knowledgeable about what they are looking 

for. A real good example that we talked about, small and very 

small plants, we worked our—our Beef Industry Food Safety Council, we decided that one of the best education tools that needed to 

be developed at the time was what we call the N60 video we use. 

N60 is a process by which we pull samples from beef combos which 

are used in making ground beef. Through observations and talking 

with a number of people, we learned that we had a lot of our plant 

people that did not know how to utilize that procedure to get the 

greatest results from it. In visiting with Mr. Almanza, he was concerned that we should also have something like that as an education tool for the inspectors. So, our group went and got together, 

we invested the money to develop that video. We sent it out to all 

of our members to all the plants. 

We also provided a little under 700 copies of that to Mr. Almanza 

so that he could get it out to the folks in the small and very small 

plants. From our standpoint we think that something that is very 

critical is to have people, whether they are plant people or whether 

they are FSIS people, they need to know what their job is. They 

70

need to know how to use the tools that we have available to enhance safety. And from our standpoint this is probably the greatest 

thing that could be done. That would be the greatest investment 

of our dollars in our opinion. 

Mr. MINNICK. Could each of the other three producer agencies 

quickly—the one thing could FSIS could do or not do that would 

most enhance your self-regulatory activities? 

Dr. KRUSHINSKIE. Speaking for the broiler industry, there are 

kind of two pieces to that. One is that we believe that we can be 

successful doing our own sorting of carcasses in line with the 

HACCP inspection models project, the HIMP model. I am not sure 

if you are familiar with that but it is taking the FSIS inspection 

staff off line and utilizing their expertise in more technical areas 

than simply inspecting carcasses. We are very strong supporters of 

the HIMP model. Second, I would like to see more true collaborative efforts, technically, with scientific technical dialogue between 

the industry experts and the FSIS decision makers, policy makers. 

We would like to encourage them to use the rulemaking process 

and to have open, transparent dialogue and conversation on rules 

rather than making some administrative decisions unilaterally. 

Mr. MINNICK. I will leave it to the Chairman to decide whether 

he would like the other two producers to answer the question. 

The CHAIRMAN. I will give the gentleman an additional 5 minutes to pursue his questions. 

Ms. APPELL. Thank you. For the pork industry, we would like to 

make sure that the focus is on food safety. I know that right now 

some of the focus is on the animal welfare, although we are not 

saying that we don’t want the animal welfare taken into consideration, but it is very important that the focus be on the food safety. 

And in addition to that, we would like to make sure that there is 

communication between the Federal and the state health associations when there is some kind of outbreak so that the situation can 

be remedied and rectified very rapidly. We think that communication needs to be improved. 

Dr. RYBOLT. I would just echo what Dr. Krushinskie has stated, 

and then just add to that that as the agency looks to modernize or 

Congress directs FSIS to modernize the inspection process to make 

sure they take risk into account, because ultimately that will provide incentives and answer your question for the industry. 

Mr. GIBBER. The egg industry, first, FSIS should issue the 

HACCP regulations for the egg products industry. It has been sitting around for many years and it is time to move that to the next 

level, and the next piece should be risk-based inspection rather 

than having a man sit outside a hot room or an inspector sit outside a hot room for product that can’t move for 7 days, sitting there 

watching the thermometer which is all recorded. It seems to be 

both a waste of time and energy for people. 

Mr. MINNICK. Thank you, Mr. Chairman. I yield back the balance 

of my time. Excuse me. I apologize. 

Mr. CARPENTER. The one thing that FSIS could do is—they need 

to work closely with the industry to design a risk-based system 

that will use process controls to make the decisions they make on 

food safety. That would focus their resources and their efforts, and 

71

it would have a tremendous impact on the overall food safety position. 

Mr. MINNICK. I thank all of you. I yield back my time. 

The CHAIRMAN. Mr. Carpenter, let me just pursue that because 

the one operative word in this whole hearing beyond the word safety is risk, and in your testimony and just now you talked about it. 

Give us an idea of what you believe a risk-based system should entail. 

Mr. CARPENTER. I think the first thing you have to do is you 

have to evaluate the products and the uses of the products. When 

you look at the manufacturers of those products, look at the redundancy of controls to eliminate and restrict those potential health 

hazards. As you move forward with the process, and to use an example, if you are taking a product that is a ready-to-eat product, 

the risk associated with that and the potential for future intervention to protect the—to control the food safety of the product are 

very minimal, as opposed to a raw product which, yes, will have 

been through some interventions to minimize microbial loads and 

things like that. But, you can expect there is likely to be additional 

food safety processes that happen to that product, so you have to 

look at things like the status of the product, how it is going to be 

used to determine what that risk might be. 

The CHAIRMAN. How do you think high risk facilities should be 

identified and how long should they be kept in that high risk status? 

Mr. CARPENTER. I think you have to start out with a documented 

food safety plan in those facilities which lay out and have done the 

research to determine where their risks are, where the control 

points need to be to control those risks. Once you have designed 

that process then you have to, from a specialty perspective, you 

need to come in and look and see how effective those systems have 

been, do some validation of those systems and verify that they in 

fact are working. As you do that and find out the results of those 

tests and those verifications then you can assess just what the 

risks are and what you need to do and what additional steps need 

to be in place. But, the key component is doing a risk assessment 

so you know where the risks are and where you need to have controls in your process to eliminate those risks. 

The CHAIRMAN. Let me just ask—thank you very much, Mr. Carpenter. I mentioned earlier about a working group, Food Safety 

Working Group, that President Obama has put together. May I ask 

if any of you have been consulted by this group since it has been 

put together? 

Mr. BOYLE. Mr. Chairman, actually when the President announced the Food Safety Working Group, we sent him a letter commending him for that initiative and volunteering to be available to 

participate in any way that the White House would deem appropriate. Effective today, we have not heard back though. 

The CHAIRMAN. Well, that is good information for us to hear. We 

will certainly see if that situation might not be rectified. You all 

have a wealth of knowledge. As I mentioned earlier, this food safety program is extraordinarily important to the American people 

and we need this input. So thank you. I am glad that we got that 

72

out of the way. Ranking Member Neugebauer, do you want to ask 

a few questions? I had a couple more but I will come back later. 

Mr. NEUGEBAUER. Thank you, Mr. Chairman. You know, if you 

have been listening to some of the discussion and seen some of the 

bills that have been introduced about food safety some people have 

advocated one agency to kind of oversee all of the food safety issue. 

I would be interested to just kind of quickly down the row what 

your thoughts are on that. Mr. Boyle. 

Mr. BOYLE. I must apologize for turning on my microphone 

again. Our view is that the current FSIS system is working quite 

effectively. There are some challenges on the FDA side. Congress 

is in the process of addressing those. I think we would support 

where we are at FSIS currently. 

Mr. NEUGEBAUER. Okay. Dr. Reagan. 

Dr. REAGAN. We would support that as well, NCBA opposes the 

creation of a single food agency, but I would go on to say that it 

would be feasible to enhance the effectiveness of the existing system to improve food safety. I think we have a lot of great people 

out there on both sides. I think you would need to carefully select 

those folks. Any changes would certainly need to be science based. 

The main thing that you would not want to do is to create a system 

that would be so overburdened with so many people in it, and so 

many people to report to, that you could not run it efficiently like 

we have seen with some agencies and Homeland Security. 

Mr. NEUGEBAUER. Ms. Appell. 

Ms. APPELL. The pork industry does not have an official position 

on whether there should be a single agency or not, but what we 

are concerned about is that wherever it is located that it is efficient 

and does a good job and protects our food supply. And while there 

are discussions going on, we would like to have a seat at the table 

so that we can participate. 

Mr. NEUGEBAUER. I concur with a seat at the table. Dr. 

Krushinskie. 

Dr. KRUSHINSKIE. On behalf of the poultry industry, we are interested in seeing what decisions made by Congress and Senate on 

this issue. Personally, I think that the expertise that is housed in 

the U.S. Department of Agriculture for food-animal production 

should remain with the U.S. Department of Agriculture. I am 

somewhat concerned about FSIS inspection of the food-animal industry being under the auspices completely of Health and Human 

Services. 

Mr. NEUGEBAUER. Dr. Rybolt. 

Dr. RYBOLT. I think the devils are in the detail. You know, moving the boxes around just to move them around doesn’t really make 

sense or changing the address. We would fear, that any changes 

that are made would compromise the accomplishments that we 

have discussed here today, over the last few years since HACCP 

has been implemented, et cetera, so I guess the real answer is the 

devil is in the details. 

Mr. NEUGEBAUER. Mr. Gibber. 

Mr. GIBBER. Our industry is not in favor of whether it is one 

agency or not. However, out industry is concerned, as we have 

heard before, about throwing out people who have expertise and 

knowledge and understanding of an industry for a new group that 

73

is not really clear on it, and the threat and the danger that that 

brings. 

Mr. NEUGEBAUER. Mr. Carpenter. 

Mr. CARPENTER. Yes. The National Meat Association is satisfied 

with the way FSIS operates. With that said, we recognize there is 

always need for continuous improvement, and we encourage them 

to keep doing that. The debate over a single food safety agency is, 

certainly, secondary. The first thing we need to do is we need to 

determine what is the best way to do food safety and what the best 

process controls are and how to accomplish that, and then when 

you design the system then determine how to manage it. 

Mr. NEUGEBAUER. The last question is a yes or no question. Several of the food safety bills before Congress would direct the FDA 

to regulate on-farm production practices. Do you agree or disagree? 

Mr. BOYLE. Can I offer we don’t have a position? 

Mr. NEUGEBAUER. That is what we do. 

Mr. BOYLE. And so do we. 

Dr. REAGAN. No. 

Ms. APPELL. No. 

Dr. KRUSHINSKIE. No. 

Dr. RYBOLT. No. 

Mr. GIBBER. No. 

Mr. CARPENTER. No. 

Mr. NEUGEBAUER. Thank you. I appreciate that. Mr. Chairman, 

I apologize. I am going to have to leave the panel now. These have 

been great witnesses. Thanks for holding this hearing. We learned 

a lot today, and I think the witnesses all did say something that 

is important right here. At least, what we want to be doing is not 

focusing on the politics here, but focusing on the results and whatever is in the best interest of the American people to continue, and 

I use the word continue, to provide the safest, most highest quality 

food in the world. That is our objective, and I think we are accomplishing that. I think possibly there are some things that we can 

work with the industry and accentuate the positives and plug up 

a few of the holes, but thanks for holding this hearing. 

The CHAIRMAN. Well, thank you, Ranking Member, and I 

couldn’t have stated it better than your eloquent closing statement 

here. We certainly want to thank each and every one of you. As I 

mentioned, this is an extraordinarily important issue. Nothing 

could be more important than our food safety of the American people. We have had some scares with Salmonella with our peanuts 

and so forth, but we are on our way. We have some competent experts in this area that we will be drawing upon, and we will continue to have a dialogue with you as we move forward. Please leave 

knowing that we are partners in this process, going forward, and 

we value your input and the time that you have taken to come and 

give your testimony to us today. Thank you very much. The witnesses are dismissed, and the hearing is adjourned. 

[Whereupon, at 4:25 p.m., the Subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 

74

75

SUBMITTED LETTER OF WAYNE PACELLE, PRESIDENT AND CEO, HUMANE SOCIETY OF

THE UNITED STATES

April 30, 2009

Hon. COLLIN C. PETERSON,

Chairman,

Committee on Agriculture;

Hon. DAVID SCOTT,

Chairman,

Subcommittee on Livestock, Dairy, and Poultry, 

U.S. House of Representatives, 

Washington, D.C.

RE: Public hearing to review Federal food safety systems at the U.S. Department 

of Agriculture

Dear Chairmen Peterson and Scott:

On behalf of the Humane Society of the United States (HSUS), the country’s largest animal protection organization, and our more than 11 million supporters nationwide, I thank the Subcommittee on Livestock, Dairy, and Poultry for convening a 

public hearing to review the U.S. Department of Agriculture’s (USDA’s) food safety 

systems, and I submit this letter for inclusion in the April 23 hearing record. 

Despite repeated assurances by several of the hearing’s witnesses that their industries are committed to producing safe, wholesome product, consumer confidence 

in the safety of the nation’s food supply has fallen ‘‘significantly,’’ as reported by the 

Center for Food Integrity. In fact, fewer than 20 percent of those Americans surveyed ‘‘strongly agreed that government agencies are doing a good job ensuring the 

safety of the food we eat,’’ and U.S. consumers have greater concern about food safety than about the war in Iraq or global warming.1

Though the relationships amongst animal handling and care, animal welfare, and 

food safety are complex, scientific data have shown that mistreatment of farm animals can result in greater public health risk.2 According to the Pew Commission on 

Industrial Farm Animal Production, for example, ‘‘[p]ractices that restrict natural 

motion, such as sow gestation crates, induce high levels of stress in the animals and 

threaten their health, which in turn may threaten human health.’’ 3 A 2007 study 

conducted by Oklahoma State University and funded by the American Farm Bureau 

Federation found that 78 percent of Americans believe that ‘‘animals raised under 

high standards of care will produce safer and better tasting meat,’’ 4 yet Americans 

are losing confidence that ‘‘U.S. meat is derived from humanely treated animals.’’ 5

The approval of ballot initiatives in Arizona, California, and Florida further validates the principle that the public is concerned about the humane treatment of animals raised for food and considers several widespread, conventional confinement 

practices to be unacceptable. 

Despite the public’s well-justified and related concerns about farm animal welfare 

and food safety, since 2007, the Government Accountability Office (GAO) has classified the food safety oversight provided by the Food Safety and Inspection Service 

(FSIS) of the USDA as a ‘‘high risk’’ government program in need of significant reform. In its January 2009 High Risk Series Report to Congress, GAO expressed concern that in 2008, FSIS vacancy rates in some areas were as high as 22 percent.6

In 2008, GAO Director of Natural Resources and the Environment, Lisa Shames, 

testified before Congress regarding these long-standing shortcomings: ‘‘USDA faces 

resource challenges that may make it difficult for it to enforce HMSA [Humane 

Methods of Slaughter Act] and ensure the safety of the food supply. Although 

USDA’s budget for food safety-related activities has increased since 1988, staffing 

for these activities has declined from its highest level in 1995.’’ 7 Finally, USDA’s 

own Office of the Inspector General recently determined that ‘‘an inherent vulnerability exists that [HMSA] violations can occur and not be detected because FSIS 

does not have sufficient staffing levels to provide continuous surveillance of all operating areas within and around a slaughter establishment at all times.’’ 8

To provide higher welfare for animals raised for meat, eggs, and dairy products, 

and to better protect the safety of the nation’s food supply, serious reforms are needed, including: USDA should immediately develop a significantly improved oversight 

system to ensure that agency inspectors are observing live animals when they first 

arrive at slaughter facilities and as they are offloaded and handled in pens and 

chutes, and that the inspectors are acting to avert violations of the HMSA and regulations pursuant to that law, as well as regulations regarding nonambulatory animals. Additionally, USDA should stop excluding chickens, turkeys, and other farmed 

76

birds—who constitute approximately 95 percent of all land animals slaughtered for 

food domestically (nine billion birds per year)—from the HMSA’s protections. 

According to testimony delivered by FSIS Administrator Almanza, emphasis 

should be placed on those food products with higher levels of risk. The HSUS is in 

full agreement. One need only look to information supplied to the public by the U.S. 

Centers for Disease Control and Prevention (CDC) to determine which foodstuffs 

pose significant risk of harboring foodborne pathogens. An estimated 76 million 

cases of foodborne disease occur annually in the United States, and three of the four 

most commonly recognized foodborne infections—those caused by the bacteria 

Campylobacter, Salmonella, and E. coli O157:H7—are linked to animal products. 

Campylobacter ‘‘live in the intestines of healthy birds, and most raw poultry meat 

has Campylobacter on it.’’ Salmonella ‘‘can spread to humans via a variety of different foods of animal origin.’’ E. coli O157:H7 ‘‘has a reservoir in cattle and other 

similar animals. Human illness typically follows consumption of food or water that 

has been contaminated with microscopic amounts of cow feces.’’ 9

Immediate and serious reform is needed within Federal food safety systems. Reorganization of Federal oversight functions, an infusion of new resources, more effective use of current resources, and a series of new policies are in order, and we look 

forward to working with the Committee in advancing these reforms in order to promote food safety and provide better treatment of animals. Thank you for the opportunity to submit comments on these important issues. 

Sincerely,

WAYNE PACELLE,

President and CEO. 

References 1The Center for Food Integrity. 2008. Consumer trust in the food system: research study highlights. 2See: Greger M. 2007. The long haul: risks associated with livestock transport. 

Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science 5(4):301–11; 

Greger M. 2008. Amyloid fibrils: potential food safety implications. INTERNATIONAL

JOURNAL OF FOOD SAFETY NUTRITION AND PUBLIC HEALTH 1(2):103–15; An HSUS 

Report: Food Safety Concerns with the Slaughter of Downed Cattle at 

www.hsus.org/web-files/PDF/farm/hsus-food-safety-concerns-with-the-slaughter-ofdowned-cattle.pdf. 3Pew Commission on Industrial Farm Animal Production. 2008. Putting meat on 

the table: industrial farm animal production in America. Executive summary, p. 13. 

www.ncifap.org/limages/PCIFAPSmry.pdf. 4Lusk J.L., Norwood F.B., and Prickett R.W. 2007. Consumer preferences for farm 

animal welfare: results of a nationwide telephone survey. Oklahoma State University 

Department of Agricultural Economics. Working paper drafted August 17. 5The Center for Food Integrity, op. cit. 6 High Risk Series: An Update. GAO–09–271. Washington D.C. (Jan. 2009) 

www.gao.gov/new.items/d09271.pdf. In addition, in February 2008, the National 

Advisory Committee on Meat and Poultry Inspection expressed its ‘‘concerns with 

the current time constraints on inspection personnel and whether or not these duties can be accomplished within those limitations. FSIS must ensure that human 

resources are adequate to efficiently perform these tasks.’’ www.fsis.usda.gov/

OPPDE/NACMPI/Feb2008/EstablSyslReport.pdf. 7 Humane Methods of Handling and Slaughter: Public Reporting on Violations 

Can Identify Enforcement Challenges and Enhance Transparency. GAO–08–686T. 

Washington, D.C. (April 17, 2008). www.gao.gov/new.items/d08686t.pdf. 8 U.S. Department of Agriculture, Audit Report: Evaluation of FSIS Management 

Controls Over Pre-Slaughter Activities, Report No. 24601–0007–KC (Nov. 2008). 

www.usda.gov/oig/webdocs/24601-07-KC.pdf. 9 U.S. Centers for Disease Control and Prevention. Foodborne illness: frequently 

asked questions. www.cdc.gov/ncidod/dbmd/diseaseinfo/

foodborneinfectionslg.htm.

SUBMITTED QUESTION

Response from Alfred V. Almanza, Administrator, Food Safety and Inspection Service, U.S. Department of Agriculture 

Question. It would be helpful for the Committee if we could get more information 

on how high risk products are designated, at what point, and where is it, because 


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you have certainly in your testimony spoke very emphatically about high risk products. 

I think we certainly need to know a definition of that, and what point in the chain 

do they become high risk, what are they, because we need to know what and where 

they are in the chain and whether or not we should inspect them on a continuous 

basis, which I might ask you once we identify who and what they are, would we 

need to then put a more continuous inspection process on them? 

It would be helpful if we could get a ranking on all products and would USDA 

be the one to rank. 

Answer. High-risk products are food products that are the most likely to be contaminated, and therefore, the most likely to be associated with foodborne illness. To 

my knowledge, the government has never conducted a comprehensive examination 

of all food categories and ranked them according to risk. However, I believe this is 

an idea that warrants serious consideration. We need to look at the various levels 

of risk posed by different food products; the differing performance of the establishments that manufacture those food products, as well as the handling during storage 

and distribution. Moreover, we need to ask hard questions, such as: what level of 

inspection is appropriate for each food category, what roles are appropriate for the 

different agencies that are responsible for food safety, and how do we achieve uniformity in assessing food safety? In addition, I would add that the criteria to determine risk would have to be science-based. 

On March 14, 2009, the President created a Food Safety Working Group, cochaired by Secretary of Agriculture Tom Vilsack and Health and Human Services 

Secretary Kathleen Sebelius. Staff at all stakeholder agencies, including USDA’s 

Food Safety and Inspection Service and HHS’ Food and Drug Administration and 

Centers for Disease Control and Prevention, are already meeting regularly to discuss how producers, processors, retailers, consumers and all levels of government 

can work collaboratively to make the food we eat as safe as it can be. Among the 

issues that the working group will likely discuss is the ranking by risk of products 

across the food supply.

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