```

[Senate Hearing 110-172]
[From the U.S. Government Publishing Office]

                                                        S. Hrg. 110-172
 
                  EXAMINE THE CURRENT PET FOOD RECALL 

=======================================================================

                                HEARING

                                before a

                          SUBCOMMITTEE OF THE

            COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE

                       ONE HUNDRED TENTH CONGRESS

                             FIRST SESSION

                               __________

                            SPECIAL HEARING

                     APRIL 12, 2007--WASHINGTON, DC

                               __________

         Printed for the use of the Committee on Appropriations

  Available via the World Wide Web: http://www.gpoaccess.gov/congress/
                               index.html
                               __________

                     U.S. GOVERNMENT PRINTING OFFICE

37-883 PDF                 WASHINGTON DC:  2007
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                      COMMITTEE ON APPROPRIATIONS

                ROBERT C. BYRD, West Virginia, Chairman
DANIEL K. INOUYE, Hawaii             THAD COCHRAN, Mississippi
PATRICK J. LEAHY, Vermont            TED STEVENS, Alaska
TOM HARKIN, Iowa                     ARLEN SPECTER, Pennsylvania
BARBARA A. MIKULSKI, Maryland        PETE V. DOMENICI, New Mexico
HERB KOHL, Wisconsin                 CHRISTOPHER S. BOND, Missouri
PATTY MURRAY, Washington             MITCH McCONNELL, Kentucky
BYRON L. DORGAN, North Dakota        RICHARD C. SHELBY, Alabama
DIANNE FEINSTEIN, California         JUDD GREGG, New Hampshire
RICHARD J. DURBIN, Illinois          ROBERT F. BENNETT, Utah
TIM JOHNSON, South Dakota            LARRY CRAIG, Idaho
MARY L. LANDRIEU, Louisiana          KAY BAILEY HUTCHISON, Texas
JACK REED, Rhode Island              SAM BROWNBACK, Kansas
FRANK R. LAUTENBERG, New Jersey      WAYNE ALLARD, Colorado
BEN NELSON, Nebraska                 LAMAR ALEXANDER, Tennessee

                  Terrence E. Sauvain, Staff Director
                  Bruce Evans, Minority Staff Director
                                 ------                                

     Subcommittee on Agriculture, Rural Development, Food and Drug 
                  Administration and Related Agencies

                     HERB KOHL, Wisconsin, Chairman
TOM HARKIN, Iowa                     ROBERT F. BENNETT, Utah
BYRON L. DORGAN, North Dakota        THAD COCHRAN, Mississippi
DIANNE FEINSTEIN, California         ARLEN SPECTER, Pennsylvania
RICHARD J. DURBIN, Illinois          CHRISTOPHER S. BOND, Missouri
TIM JOHNSON, South Dakota            MITCH McCONNELL, Kentucky
BEN NELSON, Nebraska                 LARRY CRAIG, Idaho
JACK REED, Rhode Island              SAM BROWNBACK, Kansas

                           Professional Staff

                             Galen Fountain
                        Jessica Arden Frederick
                             Dianne Preece
                      Fitzhugh Elder IV (Minority)
                       Stacey McBride (Minority)
                        Graham Harper (Minority)
                         Brad Fuller (Minority)

                         Administrative Support

                             Renan Snowden

                            C O N T E N T S

                              ----------                              
                                                                   Page

Opening Statement of Senator Herb Kohl...........................     1
Statement of Senator Robert F. Bennett...........................     2
Statement of Senator Richard J. Durbin...........................     3
Statement of Stephen F. Sundlof, D.V.M., Ph.D., Director, Center 
  for Veterinary Medicine, Food and Drug Administration..........     5
    Prepared Statement of........................................     7
Product on Retail Shelves........................................     9
Growing Recall...................................................     9
Recall list......................................................     9
Identifying Recalled Product.....................................    10
Feed Inspections.................................................    10
Monitoring Animal Population.....................................    11
Public Relations.................................................    12
Human Food.......................................................    13
Reporting Requirements...........................................    13
Legal Authorities................................................    14
Inspections......................................................    15
FDA Resources....................................................    16
Recall List......................................................    16
Information to Public............................................    17
Contaminated Food on the Market..................................    19
Import Screening System..........................................    19
CDC Interaction..................................................    20
Regulation for Pet Food Industry.................................    20
Statement of Claudia A. Kirk, Associate Professor of Medicine and 
  Nutrition, University of Tennessee College of Veterinary 
  Medicine.......................................................    21
    Prepared Statement of........................................    22
Statement of Dr. Elizabeth Hodgkins, Veterinarian................    24
    Prepared Statement of........................................    26
Statement of Eric Nelson, President, American Association of Feed 
  Control Officials..............................................    27
    Prepared Statement of........................................    29
Statement of Duane Ekedahl, Executive Director, Pet Food 
  Institute......................................................    30
    Prepared Statement of........................................    32
Prepared Statement of Hon. Rosa L. DeLauro, U.S. Representative 
  From Connecticut...............................................    45

                  EXAMINE THE CURRENT PET FOOD RECALL

                              ----------                              

                        THURSDAY, APRIL 12, 2007

        U.S. Senate, Subcommittee on Agriculture, Rural 
            Development, Food and Drug Administration, and 
            Related Agencies, Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 2 p.m., in room SD-192, Dirksen 
Senate Office Building, Hon. Herb Kohl (chairman) presiding.
    Present: Senators Kohl, Byrd, Durbin, and Bennett.

                 opening statement of senator herb kohl

    Senator Kohl. At this time, we'll proceed with this 
hearing.
    We appreciate everyone coming on such short notice to 
discuss an issue that is of great concern to pet owners all 
across our country.
    On March 16, Menu Foods began recalling dog and cat foods 
produced at their facilities in Kansas and New Jersey. Their 
recall covered products made between December 3, 2006, and 
March 6, 2007. It has since been expanded to nearly 100 brands. 
Though this comprises only a portion of all the pet food in 
commercial channels, it is, indeed, a very serious issue to the 
owners of the 60 million dogs and 70 million cats all across 
the United States. Just about every American household with a 
pet is cognizant of this problem, and many are extremely 
concerned.
    While the FDA maintains that there have been approximately 
16 animal deaths attributable to this problem, other reports 
are more troubling. Banfield, the largest pet hospital network 
in the country suggests that up to 39,000 animals have gotten 
sick, and others estimate as many as 3,500 pets have likely 
died. Since the outbreak began, FDA has received over 13,000 
complaints from consumers, more than double the number they 
receive usually on all topics during an entire year. And that 
number keeps growing. People are confused. They don't know what 
is safe and what is not safe, and they have seen the recall 
expand several times now.
    Unfortunately, the FDA web site has inadvertently 
exacerbated that bewilderment. As of Monday, a page titled FDA 
Update and Synopsis stated that, quote, ``all the contaminated 
wheat gluten has been traced.'' But, a few clicks away, in a 
``Frequently Asked Questions'' section, the FDA states, quote, 
``We are still tracing the contaminated wheat gluten.'' So, 
obviously, pet owners can get two very different ideas, 
depending upon where they click.
    FDA's public assurances have failed to provide adequate 
confidence to pet owners. Each time the recall is expanded, 
they wonder, ``What's next? Is the FDA confident that this 
recall will not grow? When we will get the all-clear signal? 
And what assurances can the FDA give us with 100 percent 
confidence?''
    So, those are my key questions to our first panel. We need 
to insist that pet owners have the right information, from this 
point on. That is our central task today. Let us present 
exactly what we know in a way that I could understand if I were 
a dog owner in Appleton, Wisconsin, trying to navigate this 
huge recall.
    For many in America, pets are more than just companions, 
they are members of the family. They go out of their way to 
ensure their pet's health and happiness, often buying the most 
expensive dog or cat food on the shelf. So, when they do all of 
these things and their pet gets sick or dies for no apparent 
reason, not only is there guilt and sadness, people rightfully 
feel angry and fearful. They trust that the products on the 
store shelves will be safe for their pets, and feel betrayed 
when they are not. So, we need to make some progress in 
addressing these concerns today.
    We've gathered a good group of witnesses. Our first panel 
will include Dr. Stephen Sundlof, the director of the FDA 
Center for Veterinary Medicine, and Dr. Steve Solomon, the head 
of the FDA's field operations. They are very busy with this 
recall, and so we appreciate their taking time to join us.
    On the second panel, we will have Dr. Elizabeth Hodgkins, a 
veterinarian and director of the All About Cats, Wellness 
Center in California, and Dr. Claudia A. Kirk, Associate 
Professor of Medicine and Nutrition at the University of 
Tennessee College of Veterinary Medicine. Both of these 
witnesses have worked for the pet food industry, as well as 
their current positions. Also on the second panel we will have 
Dr. Duane Ekedahl, Executive Director of the Pet Food 
Institute, and Mr. Eric Nelson, a feed specialist with the 
Wisconsin Department of Agriculture, Trade, and Consumer 
Protection. Mr. Nelson is also the president of the American 
Association of Feed Control Officers, the group who help set 
the standards for animal feed.
    We'd like to thank all of the witnesses in advance, and we 
look forward to their testimony and their questions.
    And now I would like to turn this microphone over to the 
ranking member on this Committee, Senator Bennett.

                 statement of senator robert f. bennett

    Senator Bennett. Thank you very much, Mr. Chairman. And 
thank you for your prompt action in calling the hearing. I 
think it's very important, as you say, that people get an 
assurance of where we are.
    The products that have been recalled comprise a very small 
percentage of the total amount of pet food, roughly 1 percent, 
but that statistic is of no comfort to those who feel their 
pets are at risk, and we need to know, and hope to find out at 
this hearing, whether there is any chance that that 1 percent 
will grow. And I'd like to know how lethal that 1 percent 
really is, because 1 percent still is an awful lot of animals 
and an awful lot of companions, as you say. For many people, a 
pet is an important part of the family.
    The FDA has reacted swiftly to this incident, and we're 
glad of that. But I welcome Dr. Sundlof here, and look forward 
to what he has to tell us.
    Thank you.
    Senator Kohl. Thank you very much, Senator Bennett.
    Senator Durbin.

                 statement of senator richard j. durbin

    Senator Durbin. I want to thank Chairman Kohl and Senator 
Bennett. I called Chairman Kohl, over the Easter break and 
asked him if he would consider this hearing and he said yes, 
and we moved very quickly.
    We want to thank the witnesses, who came here on short 
notice, because I think they feel, as we do, that this is a 
matter of great urgency.
    There are two reasons why I've asked for this hearing. The 
first is because I know what pets mean to the lives of so many 
people. More than 60 percent of U.S. households own pets. 
That's more than 68 million households. Someone once said, 
``Old age means realizing you'll never own all the dogs you 
wanted to.'' Well, we love our cats and dogs and other pets. 
They give us uncompromising love and loyalty. But we owe them 
loving care in return.
    Unfortunately, with this recall we've been tracking over 
the last several weeks, many Americans are losing their cats 
and dogs to contaminated pet food. Many more are worried about 
what to feed their animals. The numbers are in dispute. The 
Food and Drug Administration suggests only 16 reported animal 
deaths due to poisoning, but other sources are in the hundreds, 
sometimes thousands. State Veterinary Medical Association 
reports significantly higher totals. Michigan reports 38 animal 
deaths; Oregon, 35. If these numbers are consistent with 
veterinarians around the country, we're looking at the 
possibility of hundreds of dead pets, maybe more.
    Most recently, Banfield Pet Hospital, the largest pet 
veterinary practice in the United States, with more than 615 
veterinary hospitals, shared data with the FDA that showed a 
30-percent increase in kidney failure among cats during the 3 
months that the contaminated food was sold. The Vet Information 
Network, linking 30,000 vets, recently did a survey of 1,400 
members, found a third reported at least one incident, and 
estimated that between 5 and 10,000 pets may have fallen ill 
from eating contaminated food, and 1 to 2,000 may have died.
    There are still many unknowns in this situation. The FDA 
investigation is ongoing. And, due to the nature of the 
contamination, we'll probably never have a definitive tally. 
The FDA also has not confirmed the source of the contamination. 
There is an association between the substance melamine and the 
pet deaths, according to FDA. That chemical is used in 
fertilizer in China, and in plastics and industrial products in 
the United States. We also don't know why a batch of Chinese 
wheat gluten was contaminated with this chemical, and, perhaps 
most importantly, we don't know why the recall unfolded so 
slowly while contaminated pet food sat on the shelves or made 
its way into the dishes of dogs and cats in homes across 
America. I think it's important we have this public hearing to 
clarify what we know, what we need to know, why this happened, 
and the steps we should take to make sure it never happens 
again.
    And that takes me to the second reason why I have asked for 
this hearing. What is the connection between E. coli on spinach 
and contaminated pet food? Unfortunately, it's the same broken 
food safety system: too many agencies--12 to 15 different 
Federal agencies--with the responsibility for food safety. Too 
many laws--up to 30 different laws with different standards--
some calling for daily inspections, others, annual inspections, 
some, much different. Too many committees on Capitol Hill that 
have jurisdiction because of all these different agencies. Too 
many special interest groups.
    What we clearly need, and Congresswoman Rosa DeLauro and I 
have been pushing for it, and will continue to, is one single 
food safety issue--agency for human food, for pet food, driven 
by science, not by politics or tradition. I think that's the 
only way we're going to get to the bottom of this, ultimately.
    What disturbs me about this incident is that it confirms, 
yet again, that pet food, as well as human food, is at risk, 
because of the gaps in the system of regulation and inspections 
that govern our food industry in America today. There are 
significant health implications to this broken system: illness, 
death, lost economic activity, and healthcare costs.
    Dr. Sundlof, who will testify today from the FDA, implied 
so much when he was quoted, more than a week ago, and here's 
what he said, after looking at the pet food contamination, ``In 
this case, we're going to have to look at this after the dust 
settles and determine if there's something from a regulatory 
standpoint that we could have done differently to prevent this 
incident from occurring.''
    There are three areas, in particular, I am concerned about. 
I hope we get into them today. First, timing. Menu Foods, the 
pet food manufacturer involved, first noticed a potential 
problem on February 20, 2007. The company has reported that, on 
this date, it first started noticing test animals were getting 
sick and refusing to eat their product. How long did the 
company wait to notify the Food and Drug Administration? Almost 
3\1/2\ weeks. They notified the Food and Drug Administration on 
March 15, 2007, after the contaminated food products for pets 
obviously were spread across this country. Why did it take so 
long? In the meantime, other companies were selling tainted 
products. And the supplier wasn't aware that it had provided 
wheat gluten contaminated with melamine. I think that companies 
that unnecessarily delay reporting and endanger human and 
animal health should face penalties, severe penalties.
    Second, I'm concerned by media reports that have stated the 
Emporia Kansas facility, where many of these products were 
made, had never been inspected. It appears that there is a 
limited Federal presence in this area. We rely on a patchwork 
of State inspection systems and voluntary compliance.
    I want to know what this patchwork looks like. I want to 
know if the FDA needs to standardize a set of processes, 
practices, and inspection systems to make sure our pets are 
protected.
    I also think we need more data and better reporting. Blogs 
and nonprofit web sites have sprouted up as the best way to 
share information on this contamination. It's a voluntary 
effort of pet owners that is spreading more information quickly 
than our Government. The Federal Government ought to be 
harnessing this power by ensuring that State veterinarians, or 
even pet owners, could comment and alert the FDA of 
contaminations in a more timely manner. If sites like 
Veterinary Information Network and PetConnection.com can do 
this, so can our Federal Government.
    There are a lot of questions asked, and we need answers. 
That's why we're here today, to learn who's inspecting pet food 
manufacturing plants, what goes into that food, and whether we 
need to update a food safety system to protect pets and human 
health.
    I thank the witnesses for being here, and I thank you, 
again, Mr. Chairman.
    Senator Kohl. We thank you, Senator Durbin.
    And now, we'd like to call our first two witnesses, Dr. 
Sundlof and Dr. Solomon, to step forward and give us their 
testimony.
    Dr. Sundlof, thank you so much. We'll start with you.
STATEMENT OF STEPHEN F. SUNDLOF, D.V.M., Ph.D., 
            DIRECTOR, CENTER FOR VETERINARY MEDICINE, 
            FOOD AND DRUG ADMINISTRATION
ACCOMPANIED BY DR. STEVEN SOLOMAN, OFFICE OF REGULATORY 
            AFFAIRS
    Dr. Sundlof. Thank you, Mr. Chairman, for the opportunity 
to appear today at this hearing.
    With me is Dr. Steve Solomon, from FDA's Office of 
Regulatory Affairs, who has been the lead in the field part of 
the investigation. And he will be helping me answer some of the 
questions on the mechanics of the investigation.
    As a pet owner and a veterinarian, I recognize how 
important pets are to many Americans, and I offer my sympathies 
to the pet owners whose pets have become ill or died due to 
this pet food contamination.
    The recall hit very close to home for me, as I have two 
dogs. And when we learned of the recall, I was feeding one of 
the products on the recall list. FDA's investigation has been 
very aggressive and comprehensive. We've been working on this, 
day and night, since we learned of this. At this time, we have 
no evidence whatsoever that any of the affected wheat gluten 
has gotten into the human food supply. And that's been 
consistent throughout the investigation. However, we are 
continuing to investigate and confirm the safety of human and 
pet food. We are leaving no stone unturned.
    Our first priority was to limit the risk of animal injury 
and death related to pet food contamination. We worked to 
quickly identify the scope of the problem, to ensure that 
manufacturer removed potentially contaminated products from the 
market, and to inform consumers not to feed their pets the 
recalled product. FDA's Office of Crisis Management activated 
FDA's Emergency Operations Center, which works seamlessly with 
a number of offices, including the Center for Veterinary 
Medicine, the district offices, FDA headquarters, the 
laboratories that were instrumental in identifying the 
melamine, the public affairs Office and the Office of 
International Programs, to alert our trading partners.
    Within 24 hours of learning, from Menu Foods, of the 
problem, FDA investigators were on site at the Emporia Kansas 
plant, searching for the source of contamination. FDA sent 
samples of wheat gluten to our Forensics Chemistry Center in 
Cincinnati, and, using advanced analytical techniques, the FDA 
scientists identified the presence of melamine within 24 hours 
of receiving a pet food sample from FDA's field staff.
    We then identified the importer and the initial distributor 
of the contaminated wheat gluten. Our investigation also 
identified the Chinese supplier. FDA has asked the Chinese 
Government to participate in this investigation. FDA issued an 
import alert on wheat gluten by the Chinese supplier to assure 
that contaminated product does not enter U.S. commerce. At this 
time, we are also sampling 100 percent of import shipments of 
wheat gluten from China and from the Netherlands. China and the 
Netherlands are the source of most of the wheat gluten imported 
into the United States.
    Ten FDA district offices have inspected manufacturing and 
distribution facilities, and five field laboratories have 
analyzed wheat gluten in pet food samples. More than 400 FDA 
employees across the country have been involved in the 
investigation, sample analysis, communication, management, and 
have taken numerous calls from consumers and veterinarians who 
reported potential illness involving their pets.
    These events give you an understanding of the thoroughness 
of the FDA's investigation, and we promptly identified the 
source, the importer, its supplier, and the parties directly 
receiving the suspect material, wheat gluten, which was 
contaminated with melamine.
    To ensure the success of the pet food recall, FDA is 
working with the recalling firms and with our many public 
health partners. We are communicating with the 50 State 
Departments of Agriculture, health authorities, veterinarians, 
and the Association of American Feed Control Officials.
    FDA is also conducting recall-effectiveness audits. These 
audits will ensure that the manufacturers and other recalling 
firms remove all recalled products from the pet food supply 
chain, and that retailers remove all recalled products from 
store shelves. This is one of the largest pet food recalls in 
history, if not the largest. However, according to the Pet Food 
Institute, the product recall currently represents less than 1 
percent of all dog and cat food on the market. This indicates 
that consumers have access to an ample supply of pet food. We 
appreciate the extraordinary cooperation of our Federal and 
State partners, health authorities, veterinarians, the news 
media, the American public, and others who have supported this 
investigation. We also appreciate the prompt action and 
cooperation of the firms who voluntarily initiated recalls and 
continued support of other distributors and retailers affected 
by the recall.

                           prepared statement

    The cooperation and coordination of all the professionals 
who worked with the FDA to respond to this contamination 
incident enhanced the FDA's ability to respond in the moment, 
to focus on the public health issue at hand, and to help ensure 
the safety of America's pet food.
    Thank you.
    [The statement follows:]

        Prepared Statement of Stephen F. Sundlof, D.V.M., Ph.D.

Introduction
    Mr. Chairman, I am Stephen F. Sundlof, Director of the FDA Center 
for Veterinary Medicine. Joining me today is Dr. Steven Solomon, Deputy 
Director for the Office of Regional Operations, for FDA's Office of 
Regulatory Affairs. Thank you for the opportunity to appear at today's 
hearing to discuss the recent contamination of pet food. As a pet 
owner, and as a veterinarian, I recognize how important pets are to 
many Americans. I offer my sympathy to pet owners whose pets have 
become ill or died due to contaminated pet food.
    The recall hit very close to home for me, as I have two dogs of my 
own. At the time that FDA first learned of the contamination, I was 
feeding my dogs one of the ``cuts and gravy'' dog foods on the recall 
list.
    FDA is conducting a thorough investigation of the pet food 
contamination. During the past four weeks we have aggressively worked 
to identify the source and scope of the contamination, to assure the 
removal of all contaminated products from the supply chain and store 
shelves, and to keep the public informed. At this point, we believe we 
have identified the source, the importer, its supplier, and all of the 
parties directly receiving the suspect material--wheat gluten 
contaminated with melamine.
    In addition to responding to the pet-related dynamic of this 
situation, we actively investigated any potential risk to the human 
food supply. At this time, we have no evidence to suggest that any of 
the imported wheat gluten contaminated with melamine entered the human 
food supply. As an added precaution, however, we have asked the Centers 
for Disease Control and Prevention to use its surveillance network to 
monitor for signs of human illness, such as increased renal failure, 
that could indicate contamination of the human food supply.
Background on FDA Regulation of Pet Food
    The pet food industry is responsible for adherence to good 
manufacturing practices. FDA conducts risk-based inspections targeted 
toward products that pose the greatest risks to public health. However, 
inspections cannot identify every potential contaminant and are only 
one aspect of our work to detect and contain problem such as this. In 
addition, it is important for all participants in the production and 
distribution process to maintain the highest standards for safety to 
protect the American consumer, whether that consumer is human or 
animal. As with human food safety, FDA recognizes that we need to use 
strong science capable of identifying both the sources of risk and 
effective control measure. To that end, FDA is working to develop a 
risk-based Animal Feed Safety System that describes how animal feed 
should made, distributed, and used. The Animal Feed Safety System is 
designed to minimize risks to humans and animals from unsafe animal 
feed.
Scope of the Pet Food Recall
    To date, manufacturers have voluntarily recalled more than 100 
brands of dog and cat food across the nation. Manufacturers 
participating in the recall of pet food products include: Menu Foods, 
Hill's Pet Nutrition, P&G Pet Care, Nestle Purina PetCare Company, Del 
Monte Pet Products, and Sunshine Mills. The importer, ChemNutra, has 
also recalled the raw ingredient, wheat gluten. Although this is one of 
the largest pet food recalls in history, according to the Pet Food 
Institute, a trade association representing pet food manufacturers, the 
product recalled currently represents less than one percent of all dog 
and cat food on the market. This indicates that consumers have access 
to an ample supply of pet food to meet the needs of their pets. 
Nonetheless, we recognize the serious risks that the contaminated pet 
food represents to pets that consume this food, which is why we are 
devoting the resources needed to assure the success of the 
investigation and the pet food recall.
    To ensure the success of the pet food recall, FDA is working with 
the recalling firms and with our many public health partners. We are 
cooperating with the 50 state departments of agriculture, health 
authorities, veterinarians, the Association of American Feed Control 
Officials. FDA is also conducting recall effectiveness audits to ensure 
manufacturers and other recalling firms remove the recalled product 
from the pet food supply chain.
Investigation of Pet Food Contamination
    FDA's investigation has been aggressive and comprehensive. As soon 
as FDA received word of a problem with pet foods, our first priority 
was to limit the risk of animal injury and death related to 
contamination. We worked to quickly identify the scope of the problem, 
to ensure that the manufacturer removed potentially-contaminated 
products from the market, and to inform consumers not to feed their 
animals the recalled products.
    FDA began a large-scale investigation. Within 24 hours of learning 
from Menu Foods of the problem, our investigators were on-site at the 
Menu Foods Emporia, Kansas plant searching for the source of 
contamination. FDA sent samples of wheat gluten to our Forensic 
Chemistry Center (FCC) in Cincinnati, and within 24 hours the FCC 
scientists confirmed the presence of melamine in samples taken from the 
pet food and wheat gluten. In addition, FDA's Office of Crisis 
Management activated FDA's Emergency Operations Center, which has 
worked seamlessly with FDA's Center for Veterinary Medicine, district 
offices, headquarters, labs, public affairs and office of international 
programs.
    More than 400 FDA employees in all 20 district offices have taken 
calls from consumers and veterinarians who reported illnesses 
potentially associated with the contaminated pet food. FDA received 
more than 12,000 reports during the past four weeks, which is more than 
twice the number of complaints that our consumer compliant coordinators 
typically receive in a year. Additionally, ten FDA district offices 
have inspected manufacturing and distribution facilities and five field 
laboratories have analyzed samples.
    To ensure consumers awareness of the contamination, FDA 
participated in six on-camera broadcast interviews, answered hundreds 
of inquiries from media outlets across the world and conducted five 
media briefings with 75 to 100 reporters. To keep consumers up to date 
on the recalled pet foods, FDA continues to give background phone 
interviews and updates to broadcast media.
    A review of records allowed FDA to identify the importer and 
initial distributor of the contaminated wheat gluten. Through our 
investigation, FDA determined the Chinese supplier, Xuzhou Anying 
Biologic Technology Development Company. FDA has asked the Chinese 
government to participate in the investigation. To prevent 
manufacturers from using contaminated wheat gluten in pet food and to 
assess how widespread the melamine contamination of wheat gluten is, 
FDA issued an import alert regarding the supplier from China. Under 
FDA's import alert, we are detaining all wheat gluten imported from 
Xuzhou Anying Biologic Technology Development Company to assure that 
contaminated product does not enter U.S. commerce. We also initiated an 
import sampling assignment. This assignment requires 100 percent 
sampling of import shipments of wheat gluten from China and from the 
Netherlands, which is known to source some of its wheat gluten from 
China.
    To understand how the contamination affected dogs and cats, FDA 
scientists, in conjunction with academia and industry, are reviewing 
blood and tissue samples of affected animals to understand how wheat 
gluten contaminated with melamine contributed to the pet illnesses. We 
are also working with data from Banfield Pet Hospital, (a nationwide 
network of veterinary hospitals), the Veterinary Information Network, 
Poison Control Centers, universities, and other organizations to assess 
the number of cats and dogs affected by the contaminated wheat gluten. 
This is a collaborative partnership providing FDA access to information 
and helping FDA deliver essential health communications about the 
safety of pets.
Closing
    This investigation has been a massive effort drawing from many 
parts of the FDA and will continue until we are completely satisfied 
that the cause has been determined, the scope identified, and full and 
complete corrective action is initiated and effective. Thousands of 
dedicated professionals across the country are working to respond to 
this contamination. We will continue to monitor the ongoing recalls to 
ensure that they are effective and to support the safety of all food 
and animal feed in the United States. We will also promptly inform the 
public of any additional findings from the investigation on the recent 
outbreak of cat and dog illness.
    We appreciate the extraordinary cooperation of our Federal and 
State partners, health authorities, veterinarians, the news media, the 
American public, and others who have supported this investigation. We 
also appreciate the prompt action and cooperation of the firms who 
voluntarily initiated recalls and the continued support of other 
distributors and retailers affected by the recall. The cooperation and 
coordination of all of the professionals in this contamination incident 
enhanced FDA's ability to respond in the moment, to focus on the public 
health issue at hand, and help ensure the safety of America's pet food.

    Senator Kohl. Do you have a statement, at this time, Dr. 
Solomon.
    Dr. Solomon. No sir, thank you.
    Senator Kohl. Thank you.

                       PRODUCT ON RETAIL SHELVES

    Dr. Sundlof and Dr. Solomon, a few hours ago FDA put out a 
press release saying that there may still be some contaminated 
product on store shelves, and reminding retailers to remove it. 
And so, consumers cannot just trust that their retailer has 
removed all the bad product. What should consumers do, Dr. 
Sundlof?
    Dr. Sundlof. Thank you, Mr. Chairman.
    Well, we recognize that all of the recall audits have not 
been completed at this date. We have inspectors, both at the 
State level and the Federal level, out in the actual retail 
stores, checking to make sure that, in fact, the product is 
recalled. And we know that there's not 100 percent of the 
product off the shelf. So, we advise consumers to go back to 
our web site and make sure that, if they bought a product, that 
appears on that recall list, that they do not feed their pet 
with this recalled product.

                             GROWING RECALL

    Senator Kohl. Is the FDA confident, Dr. Sundlof, that the 
recall, at this point, will not grow to yet more products?
    Dr. Sundlof. Mr. Chairman, we are still deep into the 
investigation. We continue to identify small shipments of wheat 
gluten that may have gotten into the pet food. We continue to 
follow every lead that we have. We know where all the shipments 
went, at this point. But we're trying to account for it on a 
pound-by-pound basis, and sometimes they don't always--
reconcile. So, we're trying to reconcile all of the products so 
that we can make that final determination, that we have 
effectively covered all products.
    Senator Kohl. You're not at that point yet?
    Dr. Sundlof. We are not at that point yet.
    Senator Kohl. So, it's possible that there may be yet 
additional recall products?
    Dr. Sundlof. That's a possibility.
    Senator Kohl. All right. And you don't know when we will 
get the all-clear.
    Dr. Sundlof. No. I can't say that. I'll ask Dr. Solomon if 
he has better information.
    Dr. Solomon. No, as we've described before, this is a very 
active and ongoing investigation. We're following a lot of 
leads. We're doing a lot of testing of products. There's been 
hundreds of samples that have been tested. When we find 
additional positive samples, we immediately go out, find out 
where those samples were from, contact the firm, and work to 
get those products off the market.

                              RECALL LIST

    Senator Kohl. If consumers want to know which products are 
on the recall list, they can check your web site? Every last 
product on the recall list at any moment is on the web site. Is 
that correct?
    Dr. Sundlof. That's correct.
    Senator Kohl. And if consumers go into the store and have 
any concerns about whether or not all banned products have been 
removed, then, what, they should check very carefully with the 
proprietors in the store to be sure that they've removed all 
banned product?
    Dr. Sundlof. Well, that would be one step. But the final 
assurance is to actually check the product against the list on 
the web site.
    Senator Kohl. On the web site.
    Dr. Sundlof. Yes.
    Senator Kohl. Thank you so much.
    Dr. Solomon. If I could just add to Dr. Sundlof's comment, 
in that we did a blitz activity of 400 audit checks, and we 
found a high rate of compliance. But as Dr. Sundlof said, some 
of the products were still on the market. When we brought that 
to the retailers attention, they immediately removed it. We 
then have asked our State regulatory counterparts to assist us 
in making sure they can go out there, using the same audit 
forms and the same procedures, to continue to try and make sure 
this----
    Senator Kohl. Okay.
    Dr. Solomon [continuing]. Get the product is off the 
market.

                      IDENTIFYING RECALLED PRODUCT

    Senator Kohl. Before I turn this over to Senator Bennett, I 
just want to go back to your efforts on the recall work that 
you're doing. You've said that you're not able to state, at 
this point, with certainty, that all the recall has occurred. 
Are you totally confident, or very, very confident, that you're 
way, way over, and close to 90 to 100 percent through that 
process of identifying all recalled product?
    Dr. Sundlof. Yes, I think that's a fair statement. We've 
been able to track all the shipments, basically from China, 
throughout the distribution chain. Where we are still finding 
some issues is on individual portions of shipments getting 
diverted to other places. But based on the information that we 
have, including the Banfield data, and they've indicated that 
the number of animals that seem to be affected has peaked and 
is now going down. So, we believe that the recall has been very 
effective in preventing further illness and death in pets. And 
we believe that we've gotten the vast, vast majority off of the 
market, but we are not going to leave any of those stones 
unturned. We're really going to follow every lead that we have.
    Senator Kohl. Thank you.
    Senator Bennett.
    Senator Bennett. Thank you, Mr. Chairman.

                            FEED INSPECTIONS

    Dr. Sundlof, I understand that there are inspections of 
animal feed manufacturers, including firms that manufacture pet 
food, done by States, as well as by the FDA. Is that correct?
    Dr. Sundlof. That is correct.
    Senator Bennett. Okay. Are you satisfied that the division 
of responsibility between the FDA and the States will assure 
the safety of the animal feed supply?
    Dr. Sundlof. Yes. It's a very good partnership. We've had 
this partnership for many, many years with the States. Dr. 
Solomon has worked directly with the States, and I'd like to 
have him speak to the relationship between FDA and our State 
partners.
    Dr. Solomon. Thank you, Dr. Sundlof.
    We do work very closely with our State counterparts. We do 
work with the American Association of Feed Control Officials, 
and directly with the State departments of agriculture, State 
departments of health. We work with them through several 
different mechanisms, we have 34 States that work with us 
directly under contract and some States prefer other mechanisms 
to work with us, so we have partnerships and cooperative 
agreements with other States to try and enhance our activities. 
The important component here is that when they're working under 
contract or in partnership with us, they're following the same 
sets of guidance; they're following the same procedures for 
inspections; they're getting training at the same place that 
the FDA investigators are getting training; their work 
products, their inspections, are reviewed by the FDA, they're 
put into the FDA database. So, we see this as a good leveraging 
opportunity.
    Senator Bennett. Well, yeah, but what prompts you to 
conduct inspections through contracts with a State agency, or 
to conduct your own inspection? What is the tipping point that 
says, ``This one we use with contracts, and this we say, Let's 
use an FDA inspector'' ?
    Dr. Solomon. Thank you for that question.
    We solicit to the States and offer them the opportunity to 
work under contract. For some States, that's a good opportunity 
to increase their revenues and to be able to support the 
infrastructure in their program. Many of the States conduct 
programs under their own activities, so it's a good opportunity 
to avoid redundancy, by having one person going there. We're 
trying to avoid that the State may go in there under their own 
authorities, FDA go under their separate authorities. And this 
ensures, by working with a contract arrangement, they're 
working under the same standards, they're following the Food, 
Drug, and Cosmetic Act, and those reports are all reported into 
a central database and evaluation.

                      MONITORING ANIMAL POPULATION

    Senator Bennett. Okay. Now, Dr. Sundlof, you've heard the 
suggestion that there needs to be an organization like the CDC 
to monitor the health of the animal population. You're 
familiar, obviously, with what's done at USDA and FDA, and now 
the States. Do you have an opinion on the CDC proposal?
    Dr. Sundlof. Thank you, Senator.
    Certainly, an organization like the CDC brings a lot of 
good expertise. We've been having very good success for----
    Senator Bennett. Have you used them in this investigation?
    Dr. Sundlof. We've been in touch with them, and I've been 
assured by the CDC that whatever help we need, they would be 
willing to provide. So, those contacts have already been made.
    There is a society out there in the veterinary community 
that deals with a lot of the same kinds of issues. There's 
professional societies. One of them is called the American 
Association of Veterinary Laboratory Diagnosticians. They 
represent the scientific experts in the diagnostic labs that 
deal with animal diseases in all of the States. We are working 
with them to develop criteria by which we determine whether or 
not the illness in the animal is actually related to the pet 
food.
    And one of the questions we continuously get is, How many 
animals have been impacted? Before we can really answer that 
question definitively, we need to define, What are the criteria 
that would cause us to make that definitive connection?
    Senator Bennett. But let me get back to my question, 
though. Is the CDC proposal a good idea? I'm glad to hear the 
details of how you're working with----
    Dr. Sundlof. Yes.
    Senator Bennett [continuing]. Them, and how helpful they 
are.
    Dr. Sundlof. It's----
    Senator Bennett. And I'm glad to know that they were 
helpful here.
    Dr. Sundlof. Yes. It's----
    Senator Bennett. But we're talking in terms of policy. Do 
you think that's a good idea?
    Dr. Sundlof. It's certainly something that we should 
consider. I certainly don't see any downside to that. I would 
say that this is the first time we've really needed the 
firepower to deal with an investigation this big. In the past, 
we have not really had the need for that. This is an 
exceptional case. And I don't know if one exceptional case 
would justify that. But it's certainly something that we will 
be looking into as we continue with this.

                            PUBLIC RELATIONS

    Senator Bennett. One of the CDC responsibilities--or 
activities, I guess, better way to put it--with respect to any 
kind of finding is the fairly widespread public relations 
program. Now, the Chairman and Senator Durbin have both 
referred to some difficulties, in terms of the public relations 
aspect of the pet food outbreak. How do you feel the FDA has 
managed that issue, of making information available to pet 
owners?
    Dr. Sundlof. Well, we made the decision, early on, that we 
were going to get information out as quickly as possible, 
recognizing that we were in the midst of an early 
investigation, that the facts were going to change over time, 
that we were going to discover things that we hadn't 
anticipated before. But we felt that it was important to let 
the public know what we were doing, so that they could have as 
much confidence as possible, recognizing that they had to 
understand, also, that we did not know the full extent of the 
recall at the time. And we recognize that there was a lot of 
confusion. We didn't have all the answers, ourselves. So, it 
was, for us, a matter of either waiting until we had all of the 
information that we thought was necessary, or going out, when 
we learned new information. And we decided to take the latter 
approach.
    Senator Bennett. Yeah, I think that's probably right, that 
you tell the truth at the time, even if it's not as complete as 
you might like.
    One last quick question. Are the pet food companies 
required to notify you when they come across safety problems?
    Dr. Sundlof. Yes, they are.
    Senator Bennett. I see.
    Thank you.
    Senator Kohl. Thank you very much, Senator Bennett.
    Senator Durbin.
    Senator Durbin. Thank you very much.

                               HUMAN FOOD

    Dr. Sundlof, you said, ``No evidence that contaminated 
wheat gluten is in the human food supply.''
    Dr. Sundlof. That's correct.
    Senator Durbin. I'd like to ask you, because there was a 
report of concern that a batch of wheat gluten with the same 
lot number as the contaminated wheat gluten was introduced into 
the food-human-food manufacturing process, and then pulled 
after it had been processed into retail items. Are you aware of 
this?
    Dr. Sundlof. I'm going to defer to Dr. Solomon.
    Dr. Solomon. Thank you, Senator, for that question.
    The agency is committing a lot of resources to this, and 
there's 400 very dedicated people doing analysis, tracing back, 
tracing forward, doing inspections, investigations. In the 
thoroughness to look at that, we identified wheat gluten 
shipments from different manufacturers.
    The wheat gluten that's contaminated all came in from the 
Xuzhou Anying company. We've looked at some other large wheat 
gluten importers, and, by happenstance, found that there was a 
similar lot number to some of the contaminated. There's nothing 
unique about the lot number. The lot number was simply the date 
that the product was manufactured.
    In our concern about tracing that forward, only because a 
different manufacturer in China, or a different source in 
China, but the same lot number, we took additional steps to go 
out and test that wheat gluten with--the same lot number, and 
to test the product that that was made from, and advised the 
company to hold that product until those tests were completed. 
We did those tests very rapidly. All those tests were negative. 
All the wheat gluten from other suppliers has all tested 
negative, to date.
    Senator Durbin. Good.

                         REPORTING REQUIREMENTS

    Dr. Sundlof, you said that there is a requirement, for 
companies that discover contaminated pet food, to report to the 
FDA. And what is the timeline of that requirement?
    Dr. Sundlof. Well, anytime that they believe that they have 
a problem, they are supposed to notify us, and especially if 
they are--determined that they need to recall product. They 
need to notify us immediately. But it is up to the pet food 
company to determine when they believe they have a problem that 
is sufficient enough to notify the FDA.
    Senator Durbin. What is the penalty for failure to report 
on a timely basis?
    Dr. Sundlof. I will have to get back to you on that. I 
don't know the answer.
    [The information follows:]

    When injuries or illnesses are associated with FDA regulated 
products, the reporting process and requirements differ by the 
commodity area. Patients or consumers are never required to report to 
the FDA, but often do through formal (e.g. Consumer Complaint Report) 
or informal/indirect means (e.g. through a pharmacist or health care 
provider). In some circumstances, when health care providers receive 
information about illness or injury attributed to an FDA regulated 
product, reports may be filed with the FDA through the MedWatch system. 
In some cases such a report is mandatory. For example, hospitals, 
nursing homes, and certain other user facilities are required to report 
to FDA deaths that may be associated with medical devices.
    Manufacturers of FDA regulated products have a greater 
responsibility to alert FDA of problems associated or potentially 
associated with their products. For example, in the area of 
prescription human drugs and prescription and over the counter animal 
drugs, drug sponsors are required to submit information about adverse 
drug experiences. These reporting requirements apply to sponsors of new 
animal drugs that are used in animal feeds. Licensed medicated feed 
mills are also required to report certain adverse event information to 
FDA. Manufacturers of medical devices are required to file ``Medical 
Device Reports'' when they have reason to believe that a medical device 
may have caused or contributed to serious injury or death or has 
malfunctioned in a way that, if it recurred, would be likely to cause 
or contribute to serious injury or death. Medical device manufacturers 
are also generally required to notify FDA when they initiate a 
correction or removal of a medical device to reduce a risk to health 
posed by the device or to remedy a violation that may present a risk to 
health. Biological product manufacturers, in addition to reporting 
adverse experience information, are also required to file ``Biological 
Product Deviation Reports'' with FDA when they become aware that a 
deviation from current good manufacturing practice or from other 
requirements, or an unexpected or unforeseeable event, may affect a 
distributed, licensed product s safety, purity, or potency. Recent 
legislation will mandate, effective December 2007, that manufacturers 
of non-prescription drugs and dietary supplements report serious 
adverse events to the FDA relating to those types of products.
    Reporting of injuries or illnesses is generally not mandatory for 
food, although responsible manufacturers typically report such 
information to FDA in the interest of public health. One exception, as 
noted above, is the recently-enacted requirements for dietary 
supplements. When manufacturers fail to submit reports that are 
required by statute, a prohibited act charge may be appropriate (e.g. 
21 USC 331(e)). The acts and the causing of the acts subjects persons 
to the penalty provisions of 21 USC 333 and the injunction provisions 
of 21 USC 332. There are also fines of up to $250,000 provided for by 
18 USC 3571.

    Senator Durbin. I wish you would. And would you consider 
reporting 3 weeks after the discovery of contamination of pet 
food, or suspicion of contamination of pet food, to be timely?
    Dr. Sundlof. Well, it depends--I can't answer for what the 
company knew and when the company knew it and if they put that 
together and said, ``We have a problem with our pet food''--I 
just don't know. But certainly we would hope that as soon as 
they felt that they had a problem, that they would report to us 
immediately.
    Senator Durbin. Would you agree that their failure to 
report contaminated pet food increased the likelihood that pets 
across America, and maybe Canada, as well, would be in danger?
    Dr. Sundlof. Well, I think any delay would result in 
increased illness and death, yes.

                           LEGAL AUTHORITIES

    Senator Durbin. And could you tell me, does the Food and 
Drug Administration have the legal authority for mandatory 
recall of contaminated product?
    Dr. Sundlof. We don't have that mandatory authority. We 
have other measures that we can use to make sure that 
contaminated product doesn't get into the market, such as the 
seizure of product, if we need to go that far. But, in this 
case, all of the manufacturers that we've dealt with have 
voluntarily recalled product.
    Senator Durbin. After you announced the danger in their 
product?
    Dr. Sundlof. After Menu Foods announced their recall, all 
of the other companies that knew that they had products that 
came through Menu Foods recalled their product.

                              INSPECTIONS

    Senator Durbin. Has the Food and Drug Administration 
established basic standards for the State inspection of pet 
food processing facilities?
    Dr. Sundlof. Again, I'm going to defer to Dr. Solomon.
    Dr. Solomon. As I said before, when they're done under 
contract agreement, partnership agreement, cooperative 
agreement, then they're following the same exact processes and 
procedures. Most States are actually working to--or, have 
adopted the Food, Drug, and Cosmetic Act, so they're working 
off the same standards. And the Association for Feed Control 
Officials can talk some more about their standards that they've 
put into place.
    Senator Durbin. In my callow youth, I was working, summers, 
earning enough money to go to college, in a meatpacking 
facility in East St. Louis, Illinois. It was a pork-producing 
facility, and it had a section known as ``Dog Food.'' I don't 
need to tell you what ended up in the dog food section. But at 
that plant, we had USDA, Department of Agriculture, inspectors 
on the scene every minute of every day that the plant was in 
operation to make certain that the products that left that 
plant were wholesome. I don't know what happened to the raw 
materials of dog food after it left the plant, but at least 
until that point, it was subject to daily inspection.
    I've taken a look at your report of FDA, of the frequency 
of your inspection of pet food facilities, and it leaves 
something to be desired. Would you tell me, on average, how 
often the Food and Drug Administration inspects pet food 
processing facilities in the United States?
    Dr. Sundlof. I can't give you a statistic. I can tell you 
how many pet food establishments we've inspected since 
beginning of fiscal year 2004. I think it's on the order of 661 
pet food establishments that we have inspected. I will say that 
most of those were for BSE, mad cow, inspections, because the 
pet food manufacturers, as well as other feed manufacturers, 
are responsible for complying with those regulations. But there 
have been many that were for other reasons. Some of them were 
just routine, routine inspections, others were for cause, where 
we found a problem; for instance, last year we had a problem 
with aflatoxin in the dog food. But, over the past 3\1/2\ 
years, we have inspected approximately 30 percent of all of the 
pet food manufacturers in the United States.
    Senator Durbin. Less than one-third of the pet food 
processing facilities have been inspected once--some as many as 
three times--but once in the last 3\1/2\ years.
    Dr. Sundlof. That's correct.
    Senator Durbin. Do you think that's an adequate inspection 
to protect the quality and wholesomeness and safety of pet food 
products?
    Dr. Sundlof. Well, the way that we try and adjust our 
inspections, we look at it, at a risk basis, so we try and get 
to the most risky products first, including human food and pet 
food. We're obviously very concerned about mad cow disease, so 
we spend a lot of our activities inspecting those facilities 
that potentially manufacture feed that could result in BSE.
    Petfood is in fact, traditionally, has been a very safe 
product, and we find few problems with pet food. This is quite 
disturbing, in this case, because this is so unusual, and we're 
dealing with a substance that we had never encountered before. 
So, given the limited resources that the FDA does have for 
inspections, we really try and make sure that we hit those 
plants that pose the greatest risk. And so, in this case, we 
probably didn't inspect, because we felt that these companies 
were in compliance. And when we did go in and inspect the Menu 
Foods, in Emporia, Kansas, after we learned of the recall, we 
did an inspection, and they passed the FDA inspection.

                             FDA RESOURCES

    Senator Durbin. I am sorry that Commissioner von Eschenbach 
could not come today--we invited him, and his schedule did not 
allow his participation in this hearing because I would like to 
ask questions about the resources of the FDA. I will concede 
it's an important agency with limited resources and a lot of 
very important responsibilities, but I think what's happened 
with pet food contamination is an indication that we are not 
dedicating the most basic resources to this endeavor. And we've 
seen the outcome.

                              RECALL LIST

    The last point I'll make to you--or I'll ask you, Have you 
gone to your web site to try to find out which pet food is 
contaminated?
    Dr. Sundlof. Yes.
    Senator Durbin. And did you have any difficulty?
    Dr. Sundlof. I admit I did.
    Senator Durbin. I did, too. This is hard to follow. We've 
got to do a lot better than this, because what we have here, 
click-ons go to press releases for different companies. And so, 
if you are someone who's buying pet foods and want to go to the 
store, you have to work your way through every single press 
release to figure out all of the dangerous products. And, as 
has been mentioned, you're adding contaminated products to the 
list even today.
    Dr. Sundlof. Right.
    Senator Durbin. Can I suggest to the Food and Drug 
Administration that someone ought to spend a few minutes, go 
through your web site and put it in a user-friendly, petowner-
friendly format, so that people can be warned if there's a 
product out there that they've left on their shelves that might 
be dangerous?
    Dr. Sundlof. Point well taken, Senator.
    Senator Durbin. Thank you.
    Senator Kohl. Thank you, Senator Durbin, and Senator Byrd.
    Senator Byrd. Thank you. Thank you, Mr. Chairman.
    I thank you, Mr. Chairman and Senator Bennett and my 
Senator here from Illinois, where Mayor Daley used to be the 
mayor. And I was a good, close friend of Mayor Daley.
    With reference to the ongoing confusion and heartache 
caused by the recent recall of several brands of pet food, I am 
reminded of a poem that has always meant so much to me. It 
begins with this stanza, ``All things bright and beautiful, All 
creatures great and small, All things wise and wonderful, The 
Lord God made them all.'' I didn't write that poem. That poem 
was written by Cecil F. Alexander, and it comes from ``Hymns 
for Little Children,'' dated 1848. Now, I don't go back quite 
that far.
    There is a special relationship between pets and people. My 
little dog is a Shih Tzu. They were lapdogs. They were trained 
to be lapdogs in the palace in Tibet, China. And my wife, who 
is no longer right here where you can see her, saw this dog 
coming one day, and Erma said, ``Here comes trouble.'' And that 
has been my little dog's name ever since.
    For many Americans, their pets are not just dogs or cats, 
but are, instead, viewed as members of the family. I'm talking, 
because I know. I'm one of those people. I can tell you a lot 
about great dogs in history. Harry Truman, the former 
President, said, ``If you want a friend in Washington, get a 
dog''--or ``buy a dog.''
    Dogs, in particular, have, over time, earned the title 
``man's best friend.'' The relationship between a dog and his 
master represents unselfish, unselfish love, trust, and 
loyalty. As a pet owner and a dog lover, I have joined with 
millions of my fellow Americans in anxiously hoping that I had 
not poisoned my pet, my dog, with a special snack or a serving 
of food.
    Our pets are our companions, our soul mates, and our hedge 
against emotional turmoil. It is well known that pets assist 
emotional stability, mental health and well-being for millions 
of Americans.
    When the FDA protects our pets, they, the FDA protects the 
health of millions of Americans. Vigilance for our best friends 
is vigilance for the health of human owners.
    I hope that this hearing will bring to light, Mr. Chairman, 
the cause of the recent pet deaths and what actions the Food 
and Drug Administration will take to ensure that we never have 
to face a similar problem in the future.
    May I ask a question, Mr. Chairman?
    Senator Kohl. Yes, you may ask questions. Go right ahead.

                         INFORMATION TO PUBLIC

    Senator Byrd. Dr. Sundlof, thank you for appearing before 
the subcommittee today. We appreciate the work being done by 
the FDA to get to the bottom of this situation. One of the most 
troubling aspects of this recall has been the lack of clear 
information for the public on what products were being 
recalled.
    This problem was compounded by the expanding number of 
items on the recall list. What are the criteria that are used 
by FDA to determine which items should be recalled? You don't 
have to answer that at the moment. Can we now be certain that 
all of the tainted products are on the recall list? Now, that--
my question--and are you under oath? Would you put this--would 
you mind putting him under oath?
    Senator Kohl. Would you stand and take the oath?
    Do you solemnly swear that the testimony you provide today 
shall be the truth, the whole truth, and nothing but?
    Dr. Sundlof. I do.
    Senator Kohl. We thank you.
    Senator Byrd. Thank you.
    Sir, I have asked the question. Would you please proceed to 
answer?
    Dr. Sundlof. Thank you, Senator.
    The way that we have added products to the recall list is 
that, when we trace the contaminated wheat gluten to different 
plants that are manufacturing pet food, if we find out that 
that pet food is manufactured with the contaminated wheat 
gluten, those products go on the recall list.
    Now, in addition to that we have found products when we 
traced out the contaminated wheat gluten, didn't find that they 
went into certain products. Where we have gotten information 
from veterinarians that pet food has made an animal sick, we 
have analyzed the pet food. If we find melamine in that pet 
food, then that pet food immediately goes on the recall list. 
And that's why it's coming in pieces. As we learn more, as we 
identify new products, we put them on the recall list, and we 
try and get the information out to the public immediately. We 
think that we've accounted for just about all of it, but we 
cannot make that statement, as an absolute, at this point. And 
we will continue to look, as we get information from 
veterinarians and from universities, where they believe that 
they've identified sick pets associated with the recall, we'll 
be analyzing product and making sure that it's safe. And if it 
isn't, we will recall it.
    Senator Byrd. Thank you.
    Now, Mr. Chairman, may I say to you and Senator Bennett, 
I--and this is not a preparation for political--what is--I'm 
not running until 2012.
    I haven't said I'm running again. The good Lord will 
determine that.
    Question number 2--may I?
    Senator Kohl. Go ahead.
    Senator Byrd. There seems to be a discrepancy in 
information coming from the FDA and media outlets regarding how 
many pets have suffered injury or death due to the contaminated 
food. Can you explain the difference in the reported incidents? 
And do you have confidence in the number of fatalities and 
injuries that you are reporting to this Committee today?
    Dr. Sundlof. Thank you, Senator.
    Senator, we don't have a good number for how many animals 
may have been sick--made ill or have died as a result of this. 
We are now up to almost 15,000 phone calls that have been 
received by the FDA. We now that other organizations are also 
receiving thousands of phone calls. At this point in the 
investigation, we're just trying to make sure that no other 
pets are affected by this. And once we are sure that all of the 
contaminated pet food is off the market, then we will go back 
and start looking through all these records, with the help of a 
lot of other people, and try and come up with what we assess as 
the true prevalence of disease that has been caused by this pet 
food.
    Senator Byrd. Thank you.

                    CONTAMINATED FOOD ON THE MARKET

    Question, if I may, Mr. Chairman and Senator Bennett. Do we 
know for certain how long tainted food products have been sold 
to the public?
    Dr. Sundlof. Well, we know when the wheat gluten came into 
the United States. And that's the product that's causing the 
disease. We traced that back to the beginning of November 19, 
2006.
    Senator Byrd. Third question, if I may, Mr. Chairman. I'm 
not going to impose on you or the committee or the people or 
the witnesses. But I am a pet owner.

                        IMPORT SCREENING SYSTEM

    Question three: Can you explain to the subcommittee what 
screening systems are deployed by the FDA to ensure that 
harmful substances, like contaminated wheat gluten, do not 
poison pet food products?
    Dr. Sundlof. Senator, the pet food manufacturers are 
required to produce food that is safe, that is wholesome, that 
does not contain contaminants, and that is properly labeled. 
That's what they're required, under the Food, Drug, and 
Cosmetic Act, to do. The pet food manufacturers are responsible 
for ensuring that the ingredients that they're purchasing to 
produce their pet food are free of contaminants. We inspect the 
pet food companies, on occasion, to determine whether or not 
they are complying.
    They are supposed to maintain records of the ingredients 
that they received. And those records contain information about 
the analysis of the products. In this case, we do know that the 
Xuzhou Anying company from China did supply records of analysis 
to the United States importer. They did test for a number of 
contaminants, including pesticides, or at least the certificate 
indicated that. They did not test for melamine, and melamine 
would not normally have been a substance that we would consider 
to be a contaminant. And we're still trying to understand why 
that is. But that's how the system worked. They system is 
supposed to work, that the manufacturers are responsible for 
producing a safe product, and they are supposed to have records 
that, when we go in and inspect, show us that they have 
exercised their due diligence in making sure that those 
ingredients are safe.
    Senator Byrd. Mr. Chairman and Mr.--Senator Bennett, I have 
imposed on the time here of all. I have some further questions, 
which I will leave with the chairman, and he will either ask 
the questions or have them answered for the record. But I would 
ask that that be taken care of.
    And I'm going to take about 1 more minute.
    Senator Durbin. We'll take care of it.
    Senator Kohl. Thank you, Senator Byrd.
    Senator Byrd. Can you hear him? He's telling me to leave.
    Senator Kohl. Most politely.
    Senator Byrd. In a nice way.
    Thank you, Mr. Chairman.
    Senator Kohl. You're a good man.
    Senator Byrd. Thank you.
    Senator Kohl. Thank you so much.

                            CDC INTERACTION

    Senator Durbin. Mr. Chairman, could I ask a question?
    Senator Kohl. Yes, go right ahead, Senator Durbin.
    Senator Durbin. Can I ask you what the involvement with the 
CDC was in this investigation of contaminated pet food? Have 
you asked for any surveillance by the Centers for Disease 
Control about renal failure or kidney failure in humans?
    Dr. Sundlof. In humans, yes. Yes, we have. And when we 
learned that the wheat gluten was the cause, and we didn't 
know, at the time, whether or not wheat gluten had made it into 
the human food supply, we asked CDC to put a special emphasis 
on looking at increased incidence of renal failure in people. 
We've determined that batch material did not go into human 
food.
    Senator Durbin. Is there any evidence or statistics to 
indicate an increased incidence of renal failure?
    Dr. Sundlof. Not that I'm aware of, but we'll have to get 
back with CDC and make sure that that's correct.

                    REGULATION FOR PET FOOD INDUSTRY

    Senator Durbin. If I could make one last point, Mr. 
Chairman.
    In a letter which your agency sent in reply to 
Congresswoman DeLauro and myself, you said, at one point, when 
I asked about FDA's overall regulatory posture with respect to 
the pet food industry, ``There is no requirement pet food 
products have premarket approval by the FDA; however, FDA 
ensures that the ingredients used in pet food are safe and have 
an appropriate function in pet food.''
    Now, it's clear to me that you didn't inspect this wheat 
gluten shipment that was included in Menu pet food sold in the 
United States. Is that correct?
    Dr. Sundlof. That's correct.
    Senator Durbin. So, when you make that statement, can I 
assume that it means, in generic terms, wheat gluten, as an 
ingredient, is a safe ingredient?
    Dr. Sundlof. Yes. Its just like in human food, if there is 
something added to the food, it has to be determined to be 
safe, or generally recognized as safe, yes.
    Senator Durbin. Thank you very much.
    Dr. Sundlof. Thank you.
    Senator Bennett. I have no further questions.
    Senator Kohl. We thank you so much for coming today. You've 
put a lot of light on the problem that we face, and we have 
confidence that you're going to get to the bottom--and the very 
bottom--in the very near future.
    And, with that, we are willing to let you go.
    Dr. Sundlof. Thank you very much, Mr. Chairman.
    Senator Kohl. We will now ask the second panel to step 
forward.
    We will hear from Dr. Kirk, Mr. Nelson, Dr. Hodgkins, and 
Mr. Ekedahl.
    Dr. Kirk.
STATEMENT OF CLAUDIA A. KIRK, ASSOCIATE PROFESSOR OF 
            MEDICINE AND NUTRITION, UNIVERSITY OF 
            TENNESSEE COLLEGE OF VETERINARY MEDICINE
    Dr. Kirk. Good afternoon. Thank you, Chairman Kohl and 
Committee members, for inviting me to participate this 
afternoon.
    Today, I'd like to address three key areas in my testimony. 
My concerns cover the safety and testing of U.S. food 
ingredients, pet food manufacturing oversight, tracking adverse 
health events in companion animals.
    First, safety and testing of ingredients. It's apparent 
that the U.S. food supply for pets and people is at risk for 
accidental toxin contamination and agroterrorism. The Menu Food 
contamination was caused by undetected toxins in an ingredient 
widely used in pet food manufacturing. Contributing to the 
scope of the problem is poor tracking of the contaminated 
ingredient within the marketplace.
    This begs the question, Can we prevent future ingredient 
contaminations? I doubt that we can prevent all contaminations. 
There are hundreds of thousands of toxins, many toxins yet to 
be identified, others difficult to detect, even with 
sophisticated testing methodology. Our ability to completely 
test all samples of every imported or transported ingredient 
seems infeasible. While regulatory oversight helps to protect 
foods produced within the U.S., global suppliers are not under 
the same level of regulatory scrutiny. In the Menu Food 
example, I do not believe melamine would have been detected by 
our standard screening processes. We screen for the expected, 
and that did not include melamine.
    Increased USDA and AFIS oversight, along with the ongoing 
Homeland Security measures, can improve food safety. However, 
research into more effective screening tools and access to 
specialized laboratories are warranted. Can we limit the 
exposure to contaminated ingredients? The Menu example 
highlights the lack of adequate tracking of our ingredient 
supply. Nearly a month after the suspected ingredient was 
identified, manufacturers continue to discover products with 
the banned ingredient. This represents an additional month of 
pet exposure to potentially toxic feeds. Tracking of 
ingredients from the point of origin to final disposition will 
facilitate rapid implementation of the total recall, and 
thereby limit further exposure.
    Second, pet food manufacturing oversight. I believe the pet 
food industry is under far greater regulatory oversight than 
has been portrayed by the media. While certain aspects of these 
regulations require self-monitoring, the regulations for 
product claims, nutritional adequacy, ingredient use, and 
animal testing as stringent, well defined, and, from my 
experience with the FDA, closely monitored. Most visitors to 
pet food manufacturing facilities are impressed by the degree 
of ingredient evaluation, product testing, research, and 
quality control provided voluntarily by these companies.
    While this level of self-monitoring is not uniform across 
all companies, in my experience most manufacturers are 
extremely diligent in their efforts directed toward product 
quality and animal health.
    Would more oversight prevent pet food contaminations? In 
some cases, yes. The FDA reports on Diamond and Go!Natural Pet 
Food recalls suggested inspections may have improved adherence 
to quality control and good manufacturing practices, thereby 
preventing those contaminations. It is unlikely, however, that 
additional oversight would have fully prevented the Menu Food 
contamination.
    Could more vigilant regulatory intervention help limit 
exposure? If it were mandatory for manufacturers to immediately 
report significant adverse events to its centralized regulatory 
agents, earlier investigative action and product withdrawals 
could occur. However, establishing reasonable criteria for when 
to alert regulators is difficult.
    Finally, I'd like to discuss tracking adverse events. 
Surveillance and centralized reporting by the CDC has helped to 
identify and contain food-borne diseases in people. There are 
no such surveillance and reporting services available for 
companion animals. Complaints of adverse events, whether for 
drugs or pet foods, are directed primarily to the 
manufacturers. Because Menu Food produced products for several 
companies, multiple brands were affected. No doubt, part of the 
delay in recognizing the problem stemmed from scattered reports 
to individual companies, and no clear pattern of cases could be 
identified to indicate there was a serious problem afoot.
    Additionally, the inability to capture data and identify 
the true scope of the problem has resulted in pet-owner 
distrust of government agencies and pet food manufacturers, 
alike. While some estimates of the magnitude of pet deaths are 
clearly exaggerated, the official reports of confirmed cases 
are unrealistically low. Those attempting to report cases have 
been frustrated by the inability to contact the FDA, due to the 
overwhelming volume of calls.
    What can we do to prevent--or to improve the safety and 
limit exposure to tainted pet foods? One solution is to 
establish a centralized site for veterinarians and consumers to 
report adverse events and catalog affected cases. Earlier 
detection, notification, and withdrawal of tainted products 
will help prevent ongoing exposure. Earlier consumer 
notification will alert veterinarians to evaluate pets for 
toxic exposure and preserve needed information to document that 
exposure. Tracking pet health provides the additional benefit 
of acting as a sentinel to our human food supply.

                           PREPARED STATEMENT

    Sadly, we will never know the true scope of the Menu 
problem. It is unlikely that owners of pets that were affected 
prior to the March 16 recall can prove their pet was a victim 
of the toxicity. The pet food labels are gone, and the pets 
have been laid to rest.
    Thank you for your attention.
    [The statement follows:]

                 Prepared Statement of Claudia A. Kirk

    Good afternoon, I would like to thank the Chairman Kohl and the 
committee members for inviting me to this hearing.
    Today I would like to address 3 key areas in my testimony. My 
concerns cover (1) the safety and testing of the U.S. food ingredients, 
(2) pet food manufacturing oversight, (3) and tracking of adverse 
health events in companion animals.
Safety and Testing of Ingredients
    It is apparent that the U.S. food supply for pets and people is at 
risk for accidental toxin contamination and agriterrorism. The Menu 
Foods contamination was caused by undetected toxins in an ingredient 
widely used in pet food manufacturing. Contributing to the scope of the 
problem was poor tracking of the contaminated ingredients within the 
market place.
            Can we Prevent Future Ingredient Contaminations?
    I doubt that we can prevent all contaminations. There are hundreds-
of-thousands of toxins. Many toxins are yet unknown and others are 
difficult to detect, even with sophisticated testing protocols. Our 
ability to completely test all samples of imported or transported 
ingredients is would seem infeasible. While regulatory oversight helps 
to protect foods produced within the United States, global suppliers 
are not under the same level of regulatory scrutiny. In the Menu Foods 
example, I do not believe melamine would have been detected by our 
standard screening processes. We screen for the expected--and that does 
not include melamine. Increased USDA and APHIS oversight along with 
ongoing homeland security measures can improve food safety. However, 
research into more effective screening tools and access to specialized 
laboratories are warranted.
            Can we Limit the Exposure to Contaminated Ingredients?
    The Menu example highlights the lack of adequate tracking of our 
ingredient supply. Nearly a month after the suspected ingredient was 
identified; manufacturers continue to discover products with the banned 
ingredient. This represents an additional month of pet exposure to 
potentially toxic foods. Tracking of ingredients from the point of 
origin to final disposition will facilitate the rapid implementation of 
a total recall and thereby limit further exposure.
Pet Food Manufacturing Oversight
    I believe the pet food industry is under far greater regulatory 
oversight than has been portrayed. While certain aspects of the these 
regulations require self-monitoring, the regulations for product 
claims, nutritional adequacy, ingredients use, and animal testing are 
stringent, well defined, and from my experience with the FDA, closely 
monitored. Most visitors to pet food manufacturing facilities are 
impressed by the degree of ingredient evaluation, product testing, 
research, and quality control provided voluntarily by the companies. 
While this level of self-monitoring is not uniform across all 
companies, in my experience most manufacturers are extremely diligent 
in their efforts directed toward product quality and animal health.
            Would More Oversight Prevent Pet Food Contaminations?
    In some cases, Yes. The FDA reports on Diamond and Go Natural pet 
food recalls suggest inspections may have improved adherence to quality 
control and good manufacturing practices, thereby preventing these 
contaminations. It is unlikely that additional oversight would have 
fully prevented the Menu Foods contamination.
            Could More Vigilant Regulatory Intervention Help to Limit 
                    Exposure?
    If it were mandatory for manufacturers to immediately report 
significant adverse events to a centralized regulatory agency, earlier 
investigative action and product withdraw could occur. However, 
establishing reasonable criteria for when to alert regulators could 
still be a challenge.
Tracking Adverse Events
    Surveillance and centralized reporting provided by the CDC has 
helped to identify and contain food born disease in people. There are 
no such surveillance and reporting services available for companion 
animals. Complaints of adverse events, whether from drugs or pet foods, 
are directed primarily to manufacturers. Because Menu Foods produced 
products for several companies, multiple brands were affected. No 
doubt, part of the delay in recognizing the problem stemmed from 
scattered reports to individual companies and no clear pattern of cases 
to indicate a serious problem.
    Additionally, the inability to capture data and identify the true 
scope of the problem has resulted in pet owner distrust of government 
agencies and pet food manufacturers alike. While some estimates of the 
magnitude of pet deaths are clearly exaggerated, the official reports 
of confirmed cases are unrealistically low. Those attempting to report 
cases have been frustrated by the inability to contact the FDA due to 
the overwhelming volume of calls.
            What can we do to Improve the Safety of Pet Foods and Limit 
                    Exposure to Tainted Pet Foods?
    One solution is to establish a centralized site for veterinarians 
and consumers to report adverse events and catalog affected cases. 
Earlier detection, notification, and withdrawal of tainted products 
will help prevent ongoing exposure. Earlier consumer notification will 
alert veterinarians to evaluate pets for toxic exposure and preserve 
needed information to document such exposure. Tracking pet health 
provides the additional benefit of acting as a sentinel for the human 
food supply.
    Sadly, we will never know the true scope of the Menu problem. It is 
unlikely that owners of pets affected prior to the March 16th recall 
can prove their pet was a victim of toxicity. The pet food labels are 
long gone and their pets have been laid to rest.
    Thank you for your attention.

    Senator Kohl. Thank you very much, Dr. Kirk.
    Dr. Hodgkins.
STATEMENT OF DR. ELIZABETH HODGKINS, VETERINARIAN
    Dr. Hodgkins. Chairman Kohl, Senator Bennett, Senator 
Durbin, thank you all for asking me to speak this afternoon.
    I speak today not as a previous pet food company employee, 
but as a veterinarian with a deep concern for the health of my 
own pets, my many patients, and, indeed, dogs and cats 
everywhere. Notwithstanding the pet food industry's insistence 
that it is already stringently and adequately regulated, 
experience tells us otherwise. In the past 18 months alone, 
there have been no fewer than three national-level pet food 
recalls, including the most recent Menu Foods recall. Although 
the Federal Food, Drug, and Cosmetic Act requires that pet 
foods not be adulterated, the definition of which includes not 
containing any poisonous or deleterious substance, it is clear 
that breaches of this requirement are occurring at an alarming 
rate.
    The present pet food safety crisis is not an unfortunate 
aberration, but part of mounting evidence of a systemic 
breakdown in the commercial pet food safety assurances demanded 
by the pet-owning public.
    Pet foods carry both an implicit and an explicit guarantee 
of safety in the label statement that they carry, conferred by 
the American Association of Feed Control Officials, AAFCO. It 
is important to note that the sweeping safety and adequacy 
guarantees that are ubiquitous on pet food labels today cannot 
be found on any human food. No human food, whether it is fresh 
produce, meats, or commercially processed and packaged human 
consumables, is allowed to bear such broad guarantees of 
wholesomeness and nutritional completeness.
    The widely allowed, but inadequately substantiated, pet 
food AAFCO label guarantees are the fundamental flaw in the 
present system that has allowed adulterated ingredients 
repeatedly to enter the pet food supply chain. This flaw is 
also responsible for the proliferation of AAFCO statement 
labeled foods that are far from adequate for long-term feeding 
of pets as an exclusive diet.
    AAFCO label statement guarantees are not based on routine 
testing of individual ingredients by either the companies under 
whose brands those foods will be marketed or by the co-packers 
who may produce the foods for those companies at distant 
manufacturing plants. There is no systematic inspection of 
supplies--suppliers of these ingredients. Similarly, the 
nutritional adequacy guarantee explicit in this claim is not 
based on long-term feeding of guaranteed foods. The most 
rigorous testing protocol for a lifetime adequacy claim is 
based upon the feeding of a representative food, not each food, 
to a very small number of animals for a short period of time, 
only several months, at best. As long as no disastrous effects 
of the representative food are seen in these few test subjects 
over a very short period of time, the representative food will 
gain the right to carry this long-term adequacy claim, as will 
all of that company's related, but untested, foods.
    Unfortunately, because these label statements are 
ubiquitous and allow the pet food purchaser no way to 
differentiate between available commercial products, no company 
has any incentive to test and prove the quality of its foods 
beyond the bare minimums required for the AAFCO statement.
    Although the Federal Food, Drug, and Cosmetic Act requires 
that meaningful inspections of production facilities must 
occur, the increasing size of the industry has prevented this 
inspection process from keeping up with that growth. 
Governmental inspection of plants cannot solve the problem of 
adulterated ingredients, because of the sheer volume, variety, 
and sources of those ingredients. Increased facility 
inspections cannot prevent the marketing of foods with 
misleading claims, that they are nutritionally adequate for the 
long-term exclusive feeding of pets, since such scientific 
authentication must be proven in long-term clinical studies.
    The Federal Food, Drug, and Cosmetic Act already provides 
the framework for meaningful regulation of the pet food 
industry, without new laws and without a significant increase 
in the size of government. What we need now is stronger 
adherence to the simple, clear meaning of the act.
    To begin meaningful reform, I propose that the FDA adhere 
to the letter of the Federal Food, Drug, and Cosmetic Act that 
pet food labeling may not be false and misleading, by adopting 
a presumption that all safety and nutritional adequacy claims 
for pet food are disallowed. Petfoods could be marketed without 
claims, as is the case with almost all human foods, with 
consumers and veterinarians aware that the product carries no 
label claims for safety or nutritional adequacy.
    Thereafter, the pet food industry and FDA/AAFCO might well 
work out a system of honestly informative label statements that 
notify pet owners and veterinarians of the actual safety and 
adequacy testing to which each labeled food is subject. No 
implicit or explicit safety claims could be made without 
rigorous ingredient testing by the manufacturer and/or the 
ingredient supplier. No long-term nutritional adequacy claims 
could be made without long-term, well-controlled clinical 
studies proving that adequacy to genuine scientific standards.
    Conscientious manufacturers would undoubtedly rise to the 
occasion and properly test their ingredients and their finished 
foods themselves in order to gain the competitive advantage 
that honest, carefully allowed label claims would provide. The 
consumer would have a more informed choice of pet food quality, 
as indicated by truthful labels. Veterinarians would have far 
more meaningful guidance about what foods to recommend to their 
clients.

                           PREPARED STATEMENT

    There is no doubt that the present system of pet food 
regulation needs meaningful reform. This can be achieved as a 
first step by a ``truth in pet food labeling'' initiative that 
would stimulate America's best pet food-makers to provide and 
prove the quality and safety of their foods. This is no less 
than what pet owners desire and deserve, and what will be 
required to regain faltering public confidence in the industry.
    Thank you.
    [The statement follows:]

              Prepared Statement of Dr. Elizabeth Hodgkins

    Chairman Kohl, Senator Bennett, Members of the Subcomittee, I speak 
today not as a previous pet food company employee, but as a 
veterinarian with a deep concern for the health of my own pets, my many 
patients, and indeed, dogs and cats everywhere. Notwithstanding the pet 
food industry's insistence that it is already stringently and 
adequately regulated, experience tells us otherwise. In the past 16 
months alone, there have been no fewer than three national level pet 
food recalls, including the most recent Menu Foods recall. Although the 
Federal Food, Drug, and Cosmetic Act requires that pet foods not be 
``adulterated,'' the definition of which includes ``not containing any 
poisonous or deleterious substance,'' it is clear that breaches of this 
requirement are occurring at an alarming rate. The present pet food 
safety crisis is not an unfortunate aberration, but part of mounting 
evidence of a systematic breakdown in the commercial pet food safety 
assurances demanded by the pet owning public.
    Pet foods carry both an implicit and explicit guarantee of safety 
in the label statement that they carry conferred by the American 
Association of Feed Control Officials (AAFCO). It is important to note 
that the government guarantees that are ubiquitous on pet food labels 
today cannot be found on any human food. No human food, whether it is 
fresh produce, meats, or commercially processed and packaged human 
consumables is allowed to bear such sweeping, broad guarantees of 
wholesomeness and nutritional adequacy.
    These widely allowed, but poorly substantiated AAFCO label 
guarantees are the fundamental flaw in the present system that has 
allowed adulterated ingredients repeatedly to enter the pet food supply 
chain. This flaw is also responsible for the proliferation of AAFCO-
statement-labeled foods that are far from adequate for long-term 
feeding of pets, as an exclusive diet.
    AAFCO label statement guarantees are not based on routine testing 
of individual ingredients by either the companies under whose brands 
those foods will be marketed, or by the co-packers who oftentimes 
produce the foods for those companies at distant manufacturing plants. 
There is no inspection of suppliers of these ingredients. Similarly, 
the nutritional adequacy guarantee explicit in this claim is not based 
on long-term feeding of guaranteed foods. The most rigorous testing 
protocol for a lifetime adequacy claim is based upon the feeding of a 
representative food, not each food, to a very small number of animals 
for a short period of time, only several months at best. As long as no 
disastrous effects of the representative food are seen in these few 
test subjects, over a very short period of time, the representative 
food will gain the right to carry this long-term adequacy claim, as 
will all of that company's related, but untested foods. Because these 
label statements are ubiquitous and allow the pet food purchaser no way 
to differentiate between available commercial products, no company has 
any incentive to test and prove the quality of its foods beyond the 
bare minimums required for the AAFCO statement.
    Although the FFDCA requires that meaningful inspections of 
production facilities must occur, the rapidly increasing size of this 
industry has prevented this inspection process from keeping up with 
that growth. It is doubtful that governmental inspection of plants can 
solve the problem of adulterated ingredients because of the sheer 
volume, variety and sources of those ingredients. It is even more 
doubtful that increased facility inspections can prevent the marketing 
of foods with misleading claims that they are nutritionally adequate 
for the long-term feeding of pets, since such scientific authentication 
must be proven in long-term clinical studies.
    The Federal Food Drug and Cosmetic Act already provides the 
framework for meaningful regulation of the pet food industry without 
new laws and without a significant increase in the size of 
administrative government. What we need now is stronger adherence to 
the simple, clear meaning of the act. To begin meaningful reform of pet 
food regulation, I propose that AAFCO and FDA adhere to the letter of 
the FFDCA that food labeling may not be ``false or misleading'' by 
adopting a presumption that all safety and nutritional adequacy claims 
for pet food are disallowed. Under this presumption, pet foods could be 
marketed without claims, as is the case with almost all human foods, 
with pet food purchasers and veterinarians aware that the product 
carries no label claims for safety or nutritional adequacy.
    Thereafter, the pet food industry and FDA/AAFCO might well work out 
a system to allow honestly informative label statements that adequately 
notify pet owners and veterinarians of the actual safety testing and 
adequacy testing to which each labeled food is subject. No implicit or 
explicit safety claims could be made without rigorous ingredient 
testing by the manufacturer and/or the ingredient supplier. No long-
term nutritional adequacy claims could be made without long-term, well-
controlled clinical studies proving that adequacy, to genuine 
scientific standards.
    In such an environment, conscientious manufacturers would 
undoubtedly rise to the occasion and properly test their ingredients 
and their finished foods themselves in order to gain the competitive 
advantage that honest, carefully-allowed label claims would provide. 
The pet food purchaser would have a more informed choice of pet food 
quality, as indicated by truthful labels. Veterinarians would have far 
more meaningful guidance about what foods to recommend to their 
clients.
    There can be no doubt that the present system of pet food 
regulation is in need of meaningful reform. This reform can be 
achieved, as a first step, by a ``truth in pet food labeling 
initiative'' that would stimulate America's best pet food makers to 
provide and prove the quality and safety of their foods. This is no 
less than what pet owners desire and deserve, and what will be required 
to regain faltering public confidence in the industry.
    Thank you.

    Senator Kohl. Thank you, Dr. Hodgkins.
    Mr. Nelson.
STATEMENT OF ERIC NELSON, PRESIDENT, AMERICAN 
            ASSOCIATION OF FEED CONTROL OFFICIALS
    Mr. Nelson. I appear today as president of the Association 
of American Feed Control Officials. I would like to thank the 
Committee for the opportunity to provide testimony on this 
important issue.
    The safety of all animal feed, including pet food, is 
AAFCO's number one priority. I'm going to share some background 
on AAFCO, partnerships between States and FDA, and AAFCO's 
plans for added oversight of the animal feed industry.
    AAFCO is a international association, with members 
consisting largely of State feed-control officials responsible 
for the administration of State laws and rules, as well as 
portions of the Food, Drug, and Cosmetics Act, which pertain to 
the distribution of commercial feed and feed ingredients for 
livestock, poultry, and other animals, including pets. AAFCO 
counts as its members all 50 States, Canada, Puerto Rico, and 
Costa Rica.
    While AAFCO has no regulatory authority, it guides States 
through the development of model laws and regulations and 
program guidance tools, such as inspection and labeling guides. 
Individual States adopt those model elements, sometimes 
modifying them to meet local needs or issues. The AAFCO model 
pet food regulations have become the de facto national program 
for regulating the marketing of pet foods.
    While this current regulation primarily controls the 
formulation, distribution, and labeling of dog and cat foods, 
there are also safety components, since ingredients used in 
animal feeds must be defined by AAFCO. Part of the AAFCO 
definition process is a review of ingredients' safety and 
utility, as determined by FDA's Center for Veterinary Medicine, 
Division of Animal Feeds.
    Most States participate in partnership with FDA. States 
provide the--use the overarching authority of FDA to inspect 
and investigate feed manufacturers. FDA furnishes training and 
other support items, while States provide the manpower and 
coordination.
    In addition, FDA supports AAFCO in State programs through 
its scientific review activities, providing guidance and 
insight into technically sensitive issues. This guidance may 
include review of product labeling to determine suitability of 
label claims.
    Since the connection of animal feeds to BSE, AAFCO has 
directed its focus to the safety of animal feeds and the 
potential effects that unsafe feed may have on human health and 
animal health. The current system is focused primarily on 
postproduction controls, such as labeling, licensing, and 
marketing. However, AAFCO has identified gaps in this system. 
These gaps and their related risks would be best managed 
through controls on the processes used to produce and 
distribute animal feeds and feed ingredients wherever they 
occur.
    AAFCO has been working on their Model Feed Safety Program 
for several years. The intent of this model program is to 
provide regulatory direction and oversight for all 
manufacturers of animal feeds, including ingredient processors, 
livestock feed and pet food manufacturers, and manufacturers of 
feeds on farm. AAFCO's initial step was to provide guidance for 
self-regulation through quality assurance programs. However, 
AAFCO feels that simply guidance and self-regulation has not 
gone far enough to accomplish our goal of safe feed.
    Consequently, AAFCO has chosen to develop model process 
control regulations, which would be adopted and enforced by 
States. The areas addressed by the process controls include 
procedures to manage the receipt and storage of ingredients; 
responsibilities and training of personnel; processing; 
suitability and maintenance of facility and equipment; storage 
of finished products; testing of ingredients and finished 
products for contaminants and quality; and the transportation 
and distribution of both ingredients and finished products. 
These regulations would be enforced through product testing and 
inspection by State authority.
    It would be pure speculation to say that process controls 
would have prevented this terrible incident from happening. 
However, the intent of such process controls, as proposed by 
AAFCO, would be to do just that. The pet food industry and 
animal feed industry, as a whole, are very quality conscious 
and very responsive to known hazards. More needs to be done to 
identify the potential hazards, reduce their impact, and still 
provide affordable feeds and food.

                           PREPARED STATEMENT

    The status quo will not provide the security upon which our 
citizens rely. The reestablishment of consumer confidence is 
not going to happen overnight, and it will take great efforts 
by both the industry and those charged with their oversight. I 
encourage you to support FDA, AAFCO, and their State partners 
by ensuring that the necessary controls are developed, 
implemented, and funded for effective enforcement.
    Thank you.
    [The statement follows:]

                   Prepared Statement of Eric Nelson

    My name is Eric Nelson and I appear today as the President of the 
Association of American Feed Control Officials (AAFCO). I would like to 
thank the committee for the opportunity to provide testimony on this 
important issue. The safety of all animal feed, including pet food is 
AAFCO's number one priority. Strengthening both State and Federal feed 
control programs to address gaps in the current system has been 
paramount to our membership.
    I am going to share some background on AAFCO, partnerships between 
state and Federal agencies and AFFCO's plans for added oversight of the 
animal feed industry. AAFCO is an international association with 
membership consisting largely of state feed control officials 
responsible for the administration of state laws and rules, as well as 
portions of the Food, Drug and Cosmetic Act, which pertain to the 
distribution of commercial feed and feed ingredients for livestock, 
poultry and other animals, including pets. AAFCO counts as its members 
all 50 States, Canada, Puerto Rico, and Costa Rica.
    While AAFCO has no regulatory authority, it guides States through 
the development of model laws and regulations and program guidance 
tools, such as inspection and labeling guides. Individual States adopt 
these model elements, sometimes modifying them to meet local needs or 
issues. The AAFCO model pet food regulations have become the de facto 
national program for regulating the marketing of pet foods. While this 
current regulation primarily controls the formulation, distribution and 
labeling of dog and cat foods, there are also safety components, since 
ingredients used in animal feeds must be defined by AAFCO. Part of the 
AAFCO definition process is a review of the ingredient's safety and 
utility as determined by FDA's Center for Veterinary Medicine's 
Division of Animal Feeds.
    Most States participate in partnership with FDA. States use the 
overarching authorities of FDA to inspect and investigate feed 
manufacturers:
  --for compliance with the medicated feed Good Manufacturing Practices 
        (GMPs),
  --for compliance with the (Bovine Spongiform Encephalopathy) BSE feed 
        ban to prevent the establishment and amplification of BSE in 
        the U.S. cattle herd,
  --and for incidents of feed adulteration.
    Thirty five States currently have formal agreements with FDA to 
inspect feed manufacturers using the highest risk category of feed 
additives (Type A/Category II drugs) and those manufacturers and animal 
production sites that provide feeds for ruminant animals. FDA furnishes 
training and other support items, while States provide the manpower and 
coordination.
    In addition, FDA supports AAFCO and State programs through its 
scientific review activities, providing guidance and insight into 
technically sensitive issues. This guidance may include review of 
product labeling to determine suitability. FDA also provides additional 
support to States in the evaluation of label claims that may have 
health effects other than nutrition.
    Since the connection of animal feeds to BSE, AAFCO has directed its 
focus to the safety of animal feeds and the potential effect that 
unsafe feeds may have on human and animal health. The current system, 
with the exception of medicated feed regulations, is focused primarily 
on post production controls, such as: labeling, licensing and 
marketing. However, AAFCO has identified gaps in this system. These 
gaps and their related risks would be best managed through controls on 
the processes used to produce, and distribute animal feed and feed 
ingredients wherever they occur.
    AAFCO has been working on their Model Feed Safety Program for 
several years. The intent of this Model Program is to provide 
regulatory direction and oversight for all manufacturers of animal 
feeds, including: ingredient processors, livestock feed and, pet food 
manufacturers and manufacturers of feeds on-farm. AAFCO's initial step 
was to encourage the production of safe feed by:
  --providing guidance to industry through a framework of best business 
        practices;
  --and supporting industry developed and implemented Quality Assurance 
        programs.
    However, AAFCO feels that this guidance and self-regulation process 
has not been fully adopted nor has it shown results indicating our goal 
was accomplished. Consequently, AAFCO has chosen to develop model 
process control regulations, which could be adopted and enforced by 
States. The areas addressed by the process controls include procedures 
to manage:
  --the receipt and storage of ingredients,
  --responsibilities and training of personnel,
  --ingredient processing,
  --suitability and maintenance of facilities and equipment,
  --storage of finished products,
  --testing of ingredients and finished products for contaminants and 
        quality, and
  --the transportation and distribution of both ingredients and 
        finished feed products.
    These regulations would be enforced through product testing and 
facility and record inspections by the State authority.
    It would be pure speculation to say that process controls would 
have prevented this terrible incident from happening. However, the 
intent of such process controls, as proposed by AAFCO, would be to do 
just that. The pet food industry and animal feed industry, as a whole, 
are quality conscious and very responsive to known hazards. More needs 
to be done to identify the potential hazards, reduce their impact and 
still provide affordable feeds and foods.
    The status quo will not provide the security upon which our 
citizens rely. The reestablishment of consumer confidence is not going 
to happen overnight and will take great efforts by both industry and 
those charged with their oversight. I encourage you to support FDA and 
their State partners by ensuring that the necessary controls are 
developed, implemented and enforced.

    Senator Kohl. Thank you, Mr. Nelson.
    Mr. Ekedahl.
STATEMENT OF DUANE EKEDAHL, EXECUTIVE DIRECTOR, PET 
            FOOD INSTITUTE
ACCOMPANIED BY DR. ANGELE THOMPSON, CHAIRMAN, NATIONAL 
            PET FOOD COMMISSION
    Mr. Ekedahl. Thank you, Mr. Chairman.
    My name is Duane Ekedahl. I'm the president of the Pet Food 
Institute.
    Hello. Thank you.
    My name is Duane Ekedahl. I'm the president of Pet Food 
Institute, which represents the manufacturers of cat and dog 
food in the United States.
    I have--our testimony has been submitted, and I'll just 
summarize it here for you, at this time, if that's all right.
    I think I entirely understand the urgency with which you 
approach this pet food recall. In our family, we have a 12-
year-old cat, Gus, and a 4-year-old dog, Sven. And I think I 
know where I stand in the family hierarchy. And I've got to 
tell you this, if anything happened to Gus or Sven, we would be 
devastated. And our heart goes out to those people who have 
been affected by this pet food recall. And I'm here to tell you 
that our industry intends to work with this Committee and with 
the Food and Drug Administration, as we have, and will continue 
to do, until this issue comes to a close.
    Pet foods are, in fact, very highly regarded in the 
marketplace. They rank among the top products in the 
supermarket shelves, in terms of respect by consumers. A Gallup 
poll, this week, said that consumers continue to have 
confidence in pet foods, in spite of the confusion in the 
marketplace, and they're confident that pet food manufacturers 
will do the right thing and make this right, and we're 
determined to do that, at any cost.
    Today, we're going to announce--we have announced the 
formation of the National Pet Food Commission, which brings 
together the best minds, authorities in the fields of 
veterinary medicine, toxicology, pet nutrition, and government 
regulators into a commission to examine how this happened, and 
what we can learn from it, to be sure it doesn't happen again. 
This was announced, as you might have seen, in early newspapers 
today. This announces the formation of this National Pet Food 
Commission.
    And with me, if I may, Mr. Chairman, is Dr. Angele 
Thompson, who has 26 years of cat and dog nutrition experience. 
And she--Dr. Thompson will be serving on the Commission, and 
serving as its chair, and she's here to answer any questions 
that you might have.
    Now, I must insist--and I think some people are surprised 
to know this; perhaps you're not--that pet foods are, indeed, a 
highly regulated product. They are perhaps the most regulated 
product on the supermarket shelf. You pick up a package of cat 
food or dog food, and you'll see more information on that 
package than you're likely to see on any other package--any 
other package in the stores. And these--this information is 
required by law. The nutrition declarations on those products 
must be substantiated--must be substantiated and proven. And 
they are verified, by the State--chemists in the various 
States, to meet the claims that are made on those labels. 
There's no other produce like that. And these are a complete 
nutrition requirement for the cat and dog--the complete 
requirement. All the requirements are present in that product, 
the results of years of nutrition research by the--by these 
companies.
    Pet foods are--they come under many of the same regulations 
of human foods. Pet food plants are inspected, often by the 
same people that inspect human foods. Pet food ingredients are 
subject to very exacting analysis when they come to the plant. 
Many pet food ingredients, that are also human food 
ingredients, receive even more analysis in pet foods because of 
the sensitivity, sometimes, of cats and dogs to certain foods. 
So, that's the system in which pet food companies operate. It 
is a highly regulated product. And there is not confusion in 
the label claims. The nutrition claims are very specific, the 
various life stages of the cat or dog specified on the product, 
meeting the State regulations.
    What about ingredients from overseas? Our association, 
represented by Nancy Cook and other industry officials and 
government regulators, are working with the World Health 
Organization, its Codex Feed Ingredient Task Force, working 
toward the establishment of international standards for 
feedstuffs. We think this is an important goal. We work with 
other organizations. It's a major commitment on our part.
    I'd like to close with one statement, one final point. 
There is--the numbers of fatalities of cats and dogs is all 
over the place. And a recent--a Banfield report, just this 
week, cited that during the past 3 weeks they've seen 237,000--
what--a little over 237,000 cats and dogs; and, of that group, 
there were five cats and one dog affected by products in the 
recall. That's in their recent press release. Now, five cats 
and one dog are five cats and one dog too many. But that does 
suggest that this industry acted very responsibly once they 
learned that this substance, melamine, which is a contaminant, 
a contaminant of wheat gluten--wheat gluten is not the issue; 
wheat gluten is used in human food more than in pet food--this 
contamination is the issue. And once the companies learned of 
the contamination, they acted promptly to remove the product 
from the marketplace, at considerable disruption to their 
operations.
    We think what we're hearing from the Food and Drug 
Administration is that this thing is fairly close to being sure 
that this--that the products are out of the system, and that 
that part of it's been done, and that the second phase of this 
is to examine what caused it--what caused this to happen. And 
our Commission will be working on helping and augmenting the 
FDA to get the facts out there as to what caused this 
contamination, and then to report to industry and to government 
its recommendations, the steps that can be taken to assure that 
we maintain the very high standards that exist today.

                           PREPARED STATEMENT

    So, we're very hopeful that this is close to being behind 
us, so that consumers can really select, with confidence, the 
products that they choose to feed their pets in the 
marketplace, because, as we know, cats and dogs are not just 
pets, they're family. We believe that very definitely.
    Thank you, Mr. Chairman.
    [The statement follows:]

                  Prepared Statement of Duane Ekedahl

    Mr. Chairman, members of the committee. Good afternoon. On behalf 
of the pet food industry, I wish to thank you for the opportunity to 
appear before this subcommittee to provide information and counsel and 
answer any questions that I can during this difficult time for 
America's pet owners. My wife and I have a Cockapoo dog, named Sven, 
and a Persian cat, named Gus, and our hearts go out to those affected 
these by foreign substances in pet food.
    Mr. Chairman, since the very first evidence surfaced that something 
might be wrong with some pet food, our industry has been working 
closely with the Food and Drug Administration to determine the cause 
and to reassure pet owners around the country. I am here today, as part 
of that continuing cooperation with authorities and officials, to 
answer any questions lawmakers have about the industry, how it is 
organized and how the industry in general responded to the situation 
that first came to our attention the afternoon of March 16. These 
recent weeks have been difficult ones for pet owners concerned and 
confused about the recall. The industry is working diligently with the 
FDA to determine how a basic food ingredient was adulterated with a 
substance our industry has never seen and never would have expected to 
find in our products.
    The industry is committed to working tirelessly to continue our 
efforts to keep America's pets safe and healthy.
    For nearly 50 years the Pet Food Institute has been the voice of 
U.S. pet food manufacturers, representing the companies that make 98 
percent of all dog and cat food in the United States. Our member 
companies are large and small and range from America's best known and 
oldest brands to small family owned companies. Our members make both 
dry and wet foods as well as biscuits and treats for America's 150 
million dogs and cats.
    Pet food has one of the highest consumer confidence ratings of any 
product in the grocery store today. Our recent polling, and that of 
Gallup, indicates consumers have confidence in the industry even in 
this time of confusion and concern. They have faith the industry will 
take the right steps in the coming weeks. We see our cooperation with 
Congress, and with FDA, as just one of those steps.
    Pet food is perhaps the most highly regulated product on store 
shelves. In addition to companies' own high standards and proprietary 
recipes that dictate appropriate levels of nutrition, vitamins, 
minerals and flavor, pet food manufacturers are governed by the U.S. 
Food & Drug Administration, the U.S. Department of Agriculture, as well 
as authorities in all 50 states.
  --Pet foods are required by law to provide on their labels more 
        information than most human foods, and must, in fact, guarantee 
        their nutritional information, unlike ``typical'' analyses for 
        human foods.
  --State Departments of Agriculture and Regulatory Agencies provide 
        standards and enforcement policies for the regulation of pet 
        foods resulting in safe foods, through an internationally 
        recognized and respected body of regulators, the Association of 
        American Feed Control Officials. That body's ``Official 
        Publication'', revised annually by them and widely distributed 
        among regulators and industry, is recognized by many countries 
        around the world as the leading authority in pet food 
        regulation.
  --Ingredients in pet food must be acceptable to State and Federal 
        authorities.
  --The same FDA employees who inspect human food facilities may also 
        inspect pet food plants.
  --Pet foods are wholesome and truthfully labeled and meet all FDA 
        requirements.
  --Pet food ingredients undergo significant testing for safety and 
        quality assurance including screening for mycotoxins (including 
        aflatoxin), bacteria (including Salmonella and E.coli) and 
        nutrient content. Furthermore the finished product is analyzed 
        to ensure appropriate nutrient levels, which include evaluation 
        of protein (including 12 amino acids), fat, fiber, vitamins, 
        and minerals for the appropriate stage of the pet's life.
    Despite all of these requirements, at the end of the day, no 
regulations are as stringent or standards as high as the ones the 
companies set for themselves. They do everything possible to ensure 
their products deliver on their brand promises. It just makes good 
business sense that happy pets and pet owners mean happy customers.
    With respect to the current recalls, neither the investigators nor 
the industry know the exact reason why animals were sickened. But while 
the FDA continues its investigation, the pet food industry is taking 
steps to examine and, if necessary, enhance the safety and security of 
the manufacturing process.
    To that end, today I want to announce that the Pet Food Institute 
has formed an industry-government partnership called the National Pet 
Food Commission. This Commission is composed of government officials, 
veterinarians, toxicologists and nutritionists who are committed to 
maintaining and enhancing the high standards we have set in this 
country. It will include such individuals as Dr. Angele Thompson, 
nationally known pet nutritionist, who will act as Chair; as well as 
Dr. Murl Bailey, Professor of Veterinary Medicine from Texas A&M 
University; Dr. Fran Kallfelz, Professor of Veterinary Medicine, 
Cornell University; Dr. Rod Noel, of the Indiana State Chemist's office 
and AAFCO; Randy Gordon, National Grain and Feed Association; 
Christopher Cowell, Chair of Pet Food Institute's Regulatory Affairs 
Committee, and an advisor from FDA's Center for Veterinary Medicine.
    The purpose of the new Commission is two-fold:
  --First, to investigate the cause of the current pet food recall.
  --Second, to recommend steps the industry and government should take 
        to further build on the safety and quality standards already in 
        place.
    At the conclusion of its work, the Commission will issue a report 
outlining its findings and offering its recommendations to industry and 
regulators. The details of this Commission, and ultimately our full 
report, will be posted to the PFI consumer website 
www.Petfoodreport.com
    Now, let me share PFI's actions with respect to the recalls. The 
association first became aware of the recall on Friday March 16 shortly 
after 2:00 PM EDT when a call came into our offices to an associate of 
PFI charged with member relations. Menu Foods called to alert us that 
in about an hour they were issuing a recall of 60 million containers of 
``in gravy'' pet food produced in two of their four plants. Upon 
confirmation of the scope of the recall, we e-mailed an alert to our 
Board of Directors and every one of our members explaining what we had 
been told. We were on the phone with members around the country seeking 
to determine if any other companies were seeing similar issues, but 
found none at that time.
    PFI members have since participated in frequent conference calls 
for updates on the status of the recall and have cooperated fully with 
FDA in its investigation. We do feel that if FDA had been able to 
specify earlier-on what ingredient was under investigation that we 
could have assisted them in finding and removing affected products from 
commerce in a more timely fashion.
    Much of the rest of the case is well known by people who have 
followed the headlines in recent weeks. The determination by the FDA is 
that melamine, a substance completely foreign to the pet food 
manufacturing process, was present in wheat gluten, an ingredient used 
widely in both human and pet foods. This is both a puzzle, because we 
don't know how it got there, and is also a reassurance in that we seem 
to be getting closer to a conclusion.
    Regardless of assertions to the contrary, pet food produced for the 
United States is among the most regulated products on store shelves 
today. But, this was not a problem we believe more regulations can fix, 
because it was outside the parameters of any known contamination. Our 
industry routinely tests ingredients for at least as many, and in many 
cases for more contaminants than done for human food because of the 
known sensitivity of pets to certain substances, such as aflatoxin.
    For instance, we use the same grains as used in human food. 
However, where testing requirements for human food may only search for 
aflatoxin, the pet food industry testing regularly includes those for 
fumonisin, vomitoxin, zearalanone and ochratoxin, as well as other 
mycotoxins or potential contaminants that do not affect people, but 
which do affect pets. This also holds true for many other ingredients.
    Make no mistake; the pet food industry feels the FDA has done a 
superb job handling this recall. But early on, when information 
surfaced about suspicious pet illnesses and deaths, the industry could 
have been a more valuable partner in the process sooner than it was 
allowed to be. At that point, the industry should have been allowed the 
same access to critical information, in the same timeframe, as was the 
news media. If the industry had access to the same information to which 
FDA was privy, we could have cross-referenced that with lot numbers, 
shipping information and other data that perhaps could have helped 
reduce the confusion the public felt because of multiple announcements. 
If you take one thing away from my remarks today, please understand 
this. The answer to this problem is not additional regulation, rather 
it is enhanced communication.
    The FDA's investigation is ongoing and has not yet reached any 
conclusions regarding how any foreign substances entered the process. 
Only when we have this information can we make an accurate and informed 
decision about the best course of action going forward. It is our 
commitment that the members of the National Pet Food Commission will 
bring their considerable experience to bear and work to give pet owners 
peace of mind that every reasonable and possible safeguard is in place 
to protect pets in this country.
    In regards to the use of imported ingredients and the regulations 
in place that govern them, Pet Food Institute staff participates in 
both the U.S. government delegation led by FDA for the World Health 
Organization's CODEX Alimentarius Commission's Animal Feeding Task 
Force; and in the Agricultural Trade Advisory Committee (ATAC) for USDA 
and USTR. The CODEX Task Force works to establish uniform standards for 
feedstuffs around the world, and educates member states about the 
necessity of reducing and where possible, eliminating contaminants that 
pose a danger to human or animal health.
    The pet food industry is very concerned about the health of pets 
and strives to do the very best job it can to protect it at all times. 
The vast majority of pet food was never affected by the recall. 
According the Banfield Veterinary Hospital group which has been working 
with FDA, of the 237,844 pets seen by them since the onset of this 
issue, 5 cats and 1 dog have been shown to be tragically affected by 
products included in this recall.
    This is far fewer animals than the public has been led to believe, 
while the very responsible pet food industry has incurred significant 
disruption of its operations while taking extraordinary steps to 
prevent any further loss of life to pets.
    Mr. Chairman, the industry is dedicated to supporting the health of 
dogs and cats, and will continue to cooperate fully as we move forward. 
There is every reason for consumers to feel confident in the products 
we produce.
    I want to thank you again, Mr. Chairman, for this opportunity to 
testify before you today. I am happy to answer any questions you may 
have to the best of my ability.

    Senator Kohl. Thank you, Mr. Ekedahl.
    Before we proceed to questions, again, I'd like to thank 
the members of the FDA who appeared here today. And we know you 
have a conference call coming up, for which you may have to 
leave at any point. And whenever you have to leave, we 
understand.
    Mr. Nelson, you spoke at length about AAFCO's Model Safety 
Feed Program and its goals. How long has this AAFCO program 
been working? How long have you been working on this program? 
And why don't you think that these strictest self-regulations 
have been fully adopted?
    Mr. Nelson. We started the process of developing the Model 
Feed Safety Program in 2001. Like I said, initially we 
developed best business practices for companies to adopt and to 
use to evaluate their own quality assurance programs. And there 
has been some--you know, some adoption of that. Clearly, not 
enough. At that point, we decided to move on to actually 
develop model regulations, because the--with--outside of the 
medicated feed good manufacturing practices, there are very 
little process controls available for enforcement of the 
industry.
    Senator Kohl. Do you think you would have had more success 
if the FDA had mandated these regulations?
    Mr. Nelson. FDA actually is working on a similar--you know, 
a parallel path right now with their Animal Feed Safety System 
Program, which, of course--you know, that would be Federal--it 
would be a Federal program, as well, but I think, you know, 
process controls are--give it an ability to pinpoint problems 
in a quicker manner and potentially limit types of actions, 
like recalls, like this.
    Senator Kohl. Thank you.
    Dr. Kirk, we know that you previously worked as a research 
scientist for a pet food company that used the Menu Foods plant 
located in Kansas. We know that one of the things that people 
are learning and being surprised about is that so many brands 
of pet food were made at the very same plant. Can you talk us 
through how that works? Are they really all very much the same?
    Dr. Kirk. Thank you, Senator Kohl.
    The products can be very much the same if they've been 
contracted to the--to Menu Labs, and the nutritionists are 
providing their formulas. However, the products can be vastly 
different. For example, major manufacturers will come in and 
essentially rent plant time, because the equipment that is 
available at Menu is unique to the industry, in terms of making 
formed meat chunks. So, a major manufacturer, kind of like 
Coke, will protect their formula, come in with their own 
ingredients, generally, and manufacture their own product over 
a short period of time. And they'll bear no similarity to some 
of the other products. So, the--they can be vastly different or 
remarkably the same.
    Senator Kohl. Well, what we read is that many people are 
not very comfortable, to say the least, with the pet foods that 
are being sold in stores today. What advice would you give 
these pet owners? Should they try to cook their own pet food? 
And what should they do if they are as concerned as they are 
and, nevertheless, have to find food for their pets?
    Dr. Kirk. Certainly, we've received a number of those very 
questions from our own clientele. As a veterinary nutritionist, 
we have numerous calls, and calls for recipe and formulation 
individually for dogs and cats. Generally, I don't normally 
recommend people cook for their dogs and cats, just because the 
consistency of the product and their ability to provide a 
balanced diet over a prolonged period of time seems to wane. I 
feel that the products that are on the market now are generally 
safe, since the recall. I've added an extra caveat that's not 
necessarily popular, that, in the short period of time while 
we're still trying to determine whether all the wheat gluten 
has been removed, that the consumer check the actual label and 
the ingredient list to determine whether wheat gluten is used. 
And that's been my current recommendation for my clients.
    Senator Kohl. That's a good point. Thank you.
    Dr. Hodgkins, in talking about the AAFCO label guarantees 
on pet food, you say that they are not based on routine testing 
of individual ingredients. Could you give us a little bit more 
thinking on that, expand on what you said?
    Dr. Hodgkins. Yes, Senator, thank you.
    I think the current situation illustrates a very good 
example of that, that, in fact, ingredients are not being 
tested individually before they're incorporated in pet food, 
and wheat gluten would not be the only one. I think the 
regulators in the room would agree that every ingredient batch 
that comes from overseas or from local suppliers is not tested. 
That would be a daunting task, I realize. But my concern, as 
underscored in my testimony, about the implicit and explicit 
safety claim on the pet food label, would lead consumers to 
believe that it is. I think that we can only ask human beings, 
whether we're dealing with our own food or we're dealing with 
our pet's food, we can only ask a certain level of perfection 
from human beings. And I understand that. But I do believe that 
there is an unwarranted sense of safety in a pet food label 
that contains an AAFCO guarantee. And there is an issue of 
fairness to the pet food purchaser here, in my view. Are people 
led to believe that their pet foods are safer than they really 
are, safer than they can be, perhaps? And do we need to 
reexamine how we label pet food so that they, in fact, tell the 
consumer what to expect?
    Senator Kohl. Following up on that, in this case melamine 
does not appear to be an ingredient that ever would have been 
tested for. So, how do you think the situation could have been 
prevented?
    Dr. Hodgkins. That's correct. I do not believe that--
melamine might now be on a list. In my fantasy world, where pet 
food manufacturers--the better pet food manufacturers who wish 
to access safety claims might very well test for melamine, 
going in the future. And, as time goes on, perhaps they would 
add additional substances to the already substantial list--
aflatoxin, E. coli, salmonella, all of those things--so that 
list can become more safe, and more complete over time. But 
today we do know that melamine would not have been checked for, 
2 months, 3 months ago. But a pet food label that identifies 
those foods that undergo no safety testing at all, versus those 
foods that are at least undergoing safety testing that is as 
comprehensive at the time as is humanly possible, is more fair 
to pet owners. I have the same concern that the subcommittee 
has about wrapping up this investigation and making sure that 
all of the food is out of the marketplace, no more pets are 
exposed to this particular toxicity, but I am personally a good 
deal more interested in going forward and fixing what is a 
sieve of safety inadequacy assurances. And that is my focus.
    Senator Kohl. Thank you.
    Mr. Ekedahl, we have heard, and will continue to hear, that 
the pet food on the grocery shelves now is safe, but that there 
are plenty of available options. But the recall continues to 
expand--that's the point I'm making--which obviously shakes 
consumer confidence. What can you say to consumers to reassure 
them? Have companies not affected by this recall done 
additional testing to be certain that their products are safe?
    Mr. Ekedahl. Yes. I'd like--on the matter of safety, I'd 
like to cite what Dr. Sundlof said here just a few minutes ago. 
Pet foods are safe. And it's because of the safety record of 
pet foods that their resources are applied elsewhere, as 
necessary. So, the safety issue with pet foods is something--
and the consumer sees that. The consumer has a very high 
confidence level in pet food products. As to what the consumers 
can do now, I think it's been said that there are many products 
out there that are safe. The list of recalled products is very 
clear. Retailers have to be vigilant in getting their product 
off the shelves. Industry has pretty well gotten that--those 
products back and out of circulation, out of distribution. I 
think that part of it, FDA suggests, is pretty much resolved.
    So, there are many, many safe products on the market, and 
the consumer is really in a position--and the retailers--to 
assure that the products they select for their pets are safe 
products.
    Senator Kohl. Thank you.
    Senator Bennett.
    Senator Bennett. Thank you very much, Mr. Chairman.
    Dr. Hodgkins, I'm interested in your proposal to take 
labels off and then let the marketplace see the cream of the 
manufacturers rise to the top as they put their own labels on, 
under the watchful eye of the FDA to make sure that they don't 
put a false label on. Have I accurately summarized what you're 
recommending?
    Dr. Hodgkins. I believe so, Chairman, yes.
    Senator Bennett. Okay.
    And, Mr. Ekedahl, your folks are in the business. Would 
they feel that would be--that would, in fact, create a 
competitive advantage for some of the better manufacturers, and 
help the consumers?
    Mr. Ekedahl. I think there's a level playing field out 
there. I think consumers have very clear declarations as to the 
level of nutrition in that product, like no other product. 
We're always open to something that would improve the system, 
but we think we have, now, a system that works. These are 
really remarkable products. They're tested. They're tested by 
State chemists. We supply products to the highest requirements 
of every State. Our products meet the requirements of every 
State.
    Senator Bennett. So, I think what I'm hearing you say is 
that there would probably be no--probably be no changes on the 
part of those who manufacture pet food if the labeling 
situation went in the direction that Dr. Hodgkins has 
described.
    Mr. Ekedahl. I think the companies manufacture to the 
highest requirement out there, and that's what they will do. 
They'll have to do that.
    Senator Bennett. So, their labels would be sufficient--
would be roughly equivalent to each other. Her complaint is 
that the labels are all the same now, and, therefore, 
meaningless. And if I hear what you're saying, they would put 
their own labels on, and they would all be roughly equivalent, 
because they think they would stay at the same level they are 
now.
    Mr. Ekedahl. The labels really are not equivalent. It's a 
very, very competitive marketplace, and companies are able to 
describe to the consumer the advantages that they perceive in 
their products. They each have their own nutrition theories, 
their own research, and they are providing products on the 
marketplace, and that is described in their products and in 
their advertising.
    Senator Bennett. All right. I will disappoint you both by 
saying that, when we had dogs and cats, and we had a multitude 
of both throughout our family career before I came to 
Washington, I never read the label. I would go to the grocery 
story, and I would buy what the dog was used to eating, and I 
would continue to buy that same thing. And I can't tell you 
what advertising move me in one direction or another, or one 
label or another. Fortunately, all the dogs and the cats 
survived just fine. So----
    Dr. Kirk, would you--you were asked by the chairman to walk 
through one process--would you walk through another process for 
me, the process of typical screening of both suppliers and 
products?
    Dr. Kirk. Yes, thank you very much, Senator Bennett.
    I certainly can't speak to all companies' process. I can 
speak to the process I used when qualifying an ingredient. We 
would source ingredients from suppliers that we felt were 
reputable and that had a history within our company of 
providing consistent, high-quality ingredients. We would 
inspect the quality--the analysis statement. And, on that 
statement, it would not only describe the nutrient content, but 
the degree of toxin testing, which included microbial 
contamination, antibiotics, other contaminants, including heavy 
metals, aflatoxins or mycotoxins. An ingredient that we would 
suspect could be contaminated with something else--for example, 
fish--would go through additional heavy-metal screening and 
evaluation for rancidity, because those products can go rancid. 
We would have to test three different lots, three different 
shipments, and a large quantity of sampling from each 
individual shipment, so that would essentially be nine samples, 
and to evaluate not only product batch-to-batch consistency, 
but overall safety and nutritional quality. That would occur 
before we would ever agree to put that new ingredient into a 
product.
    Senator Bennett. Now, the FDA requires that Hazard Analysis 
and Critical Control Points, which I understand in the trade is 
called HACCP--we always have to acronyze--create acronyms for 
everything in government--the FDA requires that the HACCP 
systems be in place for some human foods. Would you think that 
HACCP plans required for the pet food industry would be a good 
idea?
    Dr. Kirk. That certainly is out of the scope of my 
expertise, but certainly there were those particular plans 
implemented within the plant that I was involved with; and 
truck-side testing, as well as testing throughout the 
manufacturing process was, indeed, employed.
    Senator Bennett. Would any of the other witnesses at the 
panel want to comment on whether or not HACCP systems in place 
for human food be a good idea or a bad idea?
    Mr. Nelson. If I may address the----
    Senator Bennett. Surely.
    Mr. Nelson. Committee, actually I believe right now some 
components of the pet food industry do require HACCP plans--
low-acid canning covers pet food too, if I'm not mistaken. The 
process controls that AAFCO has been developing are essentially 
ones that would be put together on known hazards, suspected 
hazards, of individual plant, based off of what type of 
activities they do. Very similar to HACCP, people tend to try 
to shy away from that word, because of, maybe, you know, 
expense nor a lack of expertise on some of those people. But 
that's the type of process controls that we're looking at, 
similar items.
    Senator Bennett. Would you agree with Mr. Ekedahl, that the 
industry is highly regulated?
    Mr. Nelson. I think the industry is highly regulated, on a 
postproduction process. Product labeling, we've talked about--
you've talked about several questions here. Requirements, most 
of the rules or regulations that deal with product labeling 
restrict labeling. The required labeling is probably about a 2-
square-inch panel on the side of the bag. The other information 
is advertising----
    Senator Bennett. Sure.
    Mr. Nelson [continuing]. And consumer information that is 
highly regulated by AAFCO and FDA to make sure it's true and 
not misleading.
    Senator Bennett. Dr. Kirk and Dr. Hodgkins, would you agree 
with Mr. Ekedahl, that this is highly regulated?
    Dr. Kirk. I would agree that a large number of aspects are 
highly regulated, as I described in my testimony. Certain other 
areas are self-monitored.
    Senator Bennett. I see.
    Dr. Hodgkins. The industry has a great deal of regulation. 
If you look at the layers, there's a whole bunch of stuff 
happening and a whole lot of groups of people involved. It's 
not effectively regulated. As I outlined in my statement, we 
don't have products that are as safe as the labels suggest, or 
as safe, perhaps, as we want them to be. And we certainly do 
not have adequacy testing that confirms that a pet can remain 
on the food for 6 months, 6 years, 2 decades, and not suffer 
harm. And there are examples in our own experience with pet 
foods that suggest that this is the case.
    Senator Bennett. Okay. Did you want a final rebuttal, Mr. 
Ekedahl, before I----
    Mr. Ekedahl. Yeah, I'm fine with it. I know--I can simply 
tell you that cats and dogs are living longer, healthier lives 
than ever before, and it's the nutrition in the product, and 
it's veterinary care. Better than ever before.
    Senator Bennett. Thank you very much.
    Senator Kohl. Thanks, Senator Bennett.
    Senator Durbin.
    Senator Durbin. Mr. Nelson, one thing I'm not clear on. Who 
funds the American Association of Feed Control Officials?
    Mr. Nelson. It's self-funding through publication of the 
official publication of AAFCO.
    Senator Durbin. So, who pays for the publications?
    Mr. Nelson. The industry, State officials, our department 
buys those for all field agents.
    Senator Durbin. So, some of your funding comes from the 
industry that you are involved with, correct?
    Mr. Nelson. Industry--actually, AAFCO is a fairly open 
process. Membership is limited to people who have actual charge 
of enforcing feed regulations. The industry does provide, you 
know, advisors, of a lack of a better term----
    Senator Durbin. What----
    Mr. Nelson [continuing]. And they come in and work with us 
on developing regulations. One of the paramount focuses of 
AAFCO is, we want to develop regulations that are understood 
and accepted by the industry.
    Senator Durbin. So, what percentage of your budget for your 
association comes from the industry that you are overseeing?
    Mr. Nelson. Oh, boy, I would have to get back to you on 
that. I really don't know.
    The association--we hold, you know, several meetings a 
year, we have one employee. So, our--you know, our budget is 
not----
    Senator Durbin. You have one employee?
    Mr. Nelson. One employee. She's the assistant secretary/
treasurer.
    Senator Durbin. And that employee is----
    Mr. Nelson. Everyone else is volunteer.
    Senator Durbin [continuing]. Is determining the nutritional 
safety of all the pet foods in America?
    Mr. Nelson. Well, it's done on a volunteer basis, through 
committees. And actually, the AAFCO----
    Senator Durbin. We know all about committees.
    Mr. Nelson. No, all--well, the AAFCO nutritional statement 
that's required on product labeling is a statement of 
nutritional adequacy. There is no implication to safety.
    Senator Durbin. That's a point I wanted to make. First, 
before I hold up this can of dog food, let me say, it is not on 
the recall list, it does not include wheat gluten. I am not 
suggesting that there is anything wrong with this brand or this 
can that I'm holding up. I've got to say that for Jack 
Danforth.
    This is Alpo, made by Ralston Purina. And there is a 
statement on the back of the label, which says, ``Purina Alpo 
Classic Chunky With Beef is formulated to meet the nutritional 
levels established by the AAFCO Dog Food Nutrient Profiles for 
Growth and Maintenance of Dogs.'' Is that a pretty common 
statement/declaration made----
    Mr. Nelson. It's the absolute----
    Senator Durbin [continuing]. For AAFCO?
    Mr. Nelson [continuing]. Required statement, yes.
    Senator Durbin. So, what you are talking about when you say 
that AAFCO is interested in safety, is nutritional safety.
    Mr. Nelson. Nutritional adequacy. Safety, long-term 
effects--you know, individual animals are going to be--they're 
individuals----
    Senator Durbin. So, this doesn't mean that any ingredient 
in this can is not contaminated.
    Mr. Nelson. No. And, actually, the--all ingredients used in 
animal feed, including pet foods, have to be defined by AAFCO. 
And there's a definition process, and FDA has--there's AAFCO 
investigators. I'm one of them. And we look at items. And 
typically they're nonfood items. These are things that come as 
byproducts and----
    Senator Durbin. And so, is it fair to say that, if I look 
at the long list of ingredients--I won't read them, but the 
AAFCO employee, or committees, have taken a look at those 
ingredients and decided this is nutritionally sound, in your 
opinion, for feeding dogs?
    Mr. Nelson. That's correct.
    Senator Durbin. Okay. So, when the word ``safety'' is used, 
that's what you're talking about. You're not talking about 
whether the plant that produced it is safe. You're not talking 
about whether the ingredients in the can are safe. You're just 
talking about, in general terms, these ingredients, fed to a 
dog, are nutritionally safe.
    Mr. Nelson. When I've been talking about safety, I am 
talking about prevention of the contamination of adulteration 
outside of the formulation of the product.
    Senator Durbin. But AAFCO makes no inspection of pet food-
producing facilities, is that correct?
    Mr. Nelson. Our member States do. Wisconsin does inspect 
pet food manufacturers.
    Senator Durbin. But not your association.
    Mr. Nelson. Not my association.
    Senator Durbin. Okay. Fair enough.
    Let me, if I could--Mr. Ekedahl, I think you've, kind of, 
used a term, which I'm going to challenge. And several people 
on the panel have agreed with it. And I'll tell you why I'm 
challenging it. You referred to dog food--pet food as a 
``highly regulated product.'' Mr. Nelson was very clear in his 
statement that ``AAFCO has no regulatory authority,'' and I 
quote him. Is that correct, Mr. Nelson?
    Mr. Nelson. Right.
    Senator Durbin. Okay. We've been told by the FDA that there 
is no premarket approval of this product sold to consumers. We 
know that there's no regular inspection of the facilities that 
make these products. What we are told is that 30 percent of 
these facilities will be inspected once or twice over a 3\1/2\ 
year period. We also know that there is no penalty for failure 
of a company, like Menu, to report if they know that their food 
is contaminated. At least we're going to check into that, but 
it appears they waited 3 weeks, and I haven't heard of a 
penalty being assessed.
    We know that there is no Government authority to recall a 
contaminated product. We know that there was no mandatory State 
inspection standards established by the Food and Drug 
Administration across the United States. We know that the 
claims being made on the label here about this dog food are 
beyond the claims that can made about human food. And we are 
told, at least Dr. Hodgkins has told us, that it's questionable 
as to whether or not a company that makes a contaminated pet 
food has to report to anyone about adverse events in a timely 
fashion, whether a dog has died or dogs are dying.
    When I go through that long list of things, it's hard to 
conclude this is a ``highly regulated product.'' What is it 
about this product that I have missed?
    Mr. Ekedahl. Well, your first point, really, is that AAFCO 
is not a regulatory body. That's absolutely correct. It's not a 
regulatory body. But the members of AAFCO are regulators in 
their States, in each of the States. And they're not supported 
by industry, they are, typically, employees of the State 
Departments of Agriculture.
    Senator Durbin. Agriculture.
    Mr. Ekedahl. That's right. And they have the responsibility 
for these products in their States.
    Senator Durbin. And does each State have the same standards 
for inspecting?
    Mr. Ekedahl. Yeah. And that's the purpose of AAFCO, is to 
develop a model----
    Senator Durbin. So----
    Mr. Ekedahl [continuing]. That applies to all the States. 
Now, all States haven't adopted the model.
    Senator Durbin. Okay. And, in this case, in Emporia, 
Kansas, we're told, there was never an inspection. So, does 
that mean the Kansas AAFCO inspection standard requires no 
inspection of production facilities?
    Mr. Ekedahl. That--those inspections would be FDA 
inspections.
    Senator Durbin. No, but----
    Mr. Ekedahl. Yeah----
    Senator Durbin [continuing]. We've just been told by the 
FDA----
    Mr. Ekedahl. The plant----
    Senator Durbin [continuing]. That those----
    Mr. Ekedahl [continuing]. Plant facility--of the facility 
would be----
    Senator Durbin. But the FDA has told us what the 
inspections amount to.
    Mr. Ekedahl. Yeah.
    Senator Durbin. Thirty percent of the facilities over a 
3\1/2\ year period of time are inspected once or twice?
    Mr. Ekedahl. But there--but there are very specific rules 
and protocols established by FDA with respect to assuring the 
safety in those plants. And companies take that very seriously. 
I mean, if you fail with that, you fail. There's a big price to 
pay for that.
    Senator Durbin. But they never show up. They come and 
inspect 30 percent of the plants over a 3\1/2\ year period of 
time?
    Mr. Ekedahl. Well, the system suggests that you don't have 
to have a cop standing at your shoulder to do the right thing 
and to produce a good product, because the marketplace will 
deal with that.
    Senator Durbin. Well, the marketplace has dealt with it, 
and a lot of consumers across America aren't going to buy Menu 
pet food for a long time. That's how the marketplace deals with 
it, because there are animals that died as a result of this pet 
food. That's how the marketplace responds.
    Mr. Ekedahl. Well, that was a contamination that came in--a 
foreign contamination of an ingredient that--all the regulation 
in the world would not--would not really have captured that----
    Senator Durbin. The point--what I'm----
    Mr. Ekedahl [continuing]. That foreign substance in an 
ingredient.
    Senator Durbin. All right, let's go to that point. We are 
increasing our importation of foreign agricultural products. I 
think it's----
    Mr. Ekedahl. Right.
    Senator Durbin [continuing]. Some $7 billion a year. So, do 
you have confidence that the next shipment of wheat gluten from 
anywhere around the world is not going to be contaminated?
    Mr. Ekedahl. No, wheat gluten--you know, there's 100-
percent examination of wheat gluten coming from either China or 
The Netherlands, which are the two largest suppliers of that 
product. Yeah, I----
    Senator Durbin. Excuse me, 100 percent inspection?
    Mr. Ekedahl. Inspection of the product coming in now--of 
wheat gluten coming in now. That's----
    Senator Durbin. You're saying that every shipment of wheat 
gluten into the United States from China is being inspected?
    Mr. Ekedahl. By FDA, yeah.
    Senator Durbin. For----
    Mr. Ekedahl. That's what they've said, yes.
    Senator Durbin. Is that since this contamination of pet 
foods?
    Mr. Ekedahl. Yes.
    Senator Durbin. Okay.
    Mr. Ekedahl. That's right. So, I think we're comfortable 
with wheat gluten. Wheat gluten, from one plant in China that 
contaminated that product, is the problem. Not wheat gluten. 
It's the contaminant that got into wheat gluten.
    Senator Durbin. I understand.
    Mr. Ekedahl. Adulterating of food substances is serious--a 
serious offense. And that happened.
    Senator Durbin. Let me go, specifically. Do you think--is 
Menu one of your----
    Mr. Ekedahl. Yes.
    Senator Durbin [continuing]. Clients companies? Do you 
think that they met the standard of care for pet owners across 
America by failing to report their suspicion of contaminated 
pet food for 3 weeks?
    Mr. Ekedahl. I have no direct knowledge of the timing----
    Senator Durbin. I'll tell you the timing.
    Mr. Ekedahl [continuing]. Of that situation.
    Senator Durbin. I can read it to you. Believe me, it was 3 
weeks, from the first notification or the first suspicion at 
Menu until they reported to the Food and Drug Administration 
that the product was dangerous. Do you think that that is the 
standard of care which pet food manufacturers should live up 
to?
    Mr. Ekedahl. I don't know that that is a standard, no. I 
don't know the facts in that case. I can tell you that once the 
melamine was determined to be the suspected agent, and once 
companies were made aware of the fact that that found their way 
to their plants, those products were recalled at once.
    Senator Durbin. They were----
    Mr. Ekedahl. That was a very responsible thing to do, for 
the----
    Senator Durbin. Now, wait a minute. Now, wait a minute. 
Let's get the record straight. Menu waited more than 3 weeks 
after finding out that the dogs wouldn't eat their food and 
were getting sick. They waited 3 weeks before they reported it 
to the FDA. The FDA, within 48 hours, recalled 95 products, or 
at least announced that they should be recalled.
    Mr. Ekedahl. Yeah.
    Senator Durbin. So, the FDA made a timely decision, once 
being notified by Menu. But Menu waited 3 weeks, or more. Now, 
let's----
    Mr. Ekedahl. I----
    Senator Durbin [continuing]. Make sure the record's 
straight on that.
    Mr. Ekedahl. Well, that's----
    Senator Durbin. And I'm asking you about Menu.
    Mr. Ekedahl. I don't have the facts on Menu, Senator. I 
don't have----
    Senator Durbin. I'd think----
    Mr. Ekedahl [continuing]. Have the direct information.
    Senator Durbin [continuing]. Before you came to the 
hearing, you would have the facts.
    Mr. Ekedahl. Well, I think that's a matter between Menu and 
FDA. I do not--we do not have the direct information as to the 
circumstances surrounding that--the timing of that recall.
    Senator Durbin. Mr. Chairman, let me say I think Dr. 
Hodgkins is onto the right suggestion. We need more timely 
reporting of anything that's suspicious so we can take a look 
quickly, before damage is done to pets, or even to humans. In 
this case, that was one of the fears. We have expanded the law 
for adverse-event reporting to the Food and Drug Administration 
for a number of things, including dietary supplements.
    I think, clearly, we need to expand and strengthen this law 
so that companies, whether it's Menu, in Canada, or other 
companies, know they have a responsibility--a corporate 
responsibility--to their customers to respond in a timely 
fashion, any adverse event so that there can be a reaction, an 
appropriate reaction, perhaps a recall of product.
    Thank you very much, Mr. Chairman.
    Senator Kohl. Dr. Kirk, can you explain how a plant, such 
as Menu, prevents cross-contamination as it moves from one 
product processing to another's product processing?
    Dr. Kirk. I cannot specifically speak to how Menu prevents 
cross-contamination, but I can speak to the individual plant 
with which I worked, and that is that, generally, a run of 
ingredients, of dummy ingredients, would essentially wash out 
the line, and then the line would be hand-cleaned to remove 
product and product contamination between the next product run. 
So, it's very standard to clean the line, where ingredients are 
going to be mixed and batched and cooked and bagged.
    Senator Kohl. And is it your expectation that all plants 
proceed in this manner?
    Dr. Kirk. No, it's not. And I personally have found, you 
know, Kibbles 'n Bits in my, you know, Cat Chow occasionally, 
so certainly those do pop up here and there. But, in general, I 
would expect that most of the major manufacturers do clean the 
lines between major shifts and changes in formulas.
    Senator Kohl. Any comment from any other panelist on the 
danger in this procedure as they move from one brand name to 
the other, in terms of----
    Yes, sir, Mr. Nelson.
    Mr. Nelson. May I address the Committee?
    Cleanout or cross-contamination is actually an item that is 
covered in detail by both State and Federal inspectors when 
they do medicated feed manufacturing. And it's actually--it's 
each individual system. So, it's a complicated process. But 
there is no requirement for that in current regulations, about 
clean outs between production, other than medicated feeds.
    Senator Kohl. There is no current requirement? Say it 
again.
    Mr. Nelson. There is no current requirement for the clean 
out of equipment prior to manufacturing other feeds, other than 
medicated feeds.
    Senator Kohl. All right.
    Yes, Dr. Hodgkins.
    Dr. Hodgkins. This would be an important consideration, 
just as we are concerned about peanut contamination for people 
who have allergies to peanuts. I'm sure plants that handle 
peanuts have to be very careful about either not manufacturing 
any other types of products or being very clean. Certainly, 
food allergies occur in dogs and cats, as well, and there are 
even products that are marketed for allergic pets and pets 
allergic to certain ingredients. So, this would be an important 
consideration. And it is a concern that there is a laxity in 
the amount of regulation that looks at that particular problem.
    Senator Kohl. Yes. Thank you.
    Any other comments or questions from Senator Durbin? 
Comments from the members of the panel?
    The subcommittee has received a statement from the 
Honorable Rosa L. DeLauro which will be placed in the hearing.
    [The statement follows:]

 Prepared Statement of Hon. Rosa L. DeLauro, U.S. Representative From 
                              Connecticut

    Mr. Chairman, I want to commend you for calling this hearing and 
thank you very much for the opportunity to present testimony.
    The recent pet food recall has raised very serious questions about 
the safety, not only of our food, but of our pets as well. It is very 
unfortunate that not even the family pet is immune from the food safety 
problems that are plaguing our country. In response to the letter that 
Senator Durbin and I sent to the FDA, Mr. Chairman, the agency claims 
that it is not ignoring its responsibility in the pet food area. 
However, to the many Americans who have lost their pets to contaminated 
foods, the initial evidence would suggest that the FDA is failing its 
responsibilities to protect pets from unsafe food as much as it is 
failing to protect American consumers.
    As Senator Durbin has stated, the FDA's response to this situation 
has been tragically slow, and pet owners deserve answers. The 
uncertainty about which foods have been recalled and what is safe to 
feed their pets has gone on far too long. I want to know how often pet 
food manufacturing plants are being inspected, and whether we need to 
force the FDA to modernize its regulations to protect our pets.
    Early in the process, I also was troubled by FDA's underreporting 
the number of pets affected by the contaminated foods. At one point, 
the agency reported that only 16 pets had died when in fact, the number 
was significantly higher than that.
    And of course, I do not have to remind you Mr. Chairman that the 
FDA has no authority to mandate recalls and instead relies on 
information submitted by companies. We saw yesterday how problematic 
this arrangement can be when Menu Foods admitted that a ``clerical 
error'' caused the company to overlook a shipment of potentially 
contaminated wheat gluten from one of its plants in the United States 
to one in Canada. This gap delayed a recall of some cat food made in 
Canada.
    We are all aware of the disturbing statistics related to imported 
foods. The United States now imports far more foods than it exports, 
but there are fewer inspectors for imported foods. Currently, FDA 
inspects less than one percent of the food imported into this country 
that it is responsible for regulating. Also, the FDA does not require 
that exporting countries to have food safety regulatory structures that 
are equivalent to the U.S. standards. Given that the contaminated pet 
food appears to be connected to wheat gluten imported from China only 
heightens my concern about the agency's ability to inspect imported 
products. It is this aspect of the pet food recall crisis that I am 
particularly troubled about and intend to examine further in a follow-
up hearing before the House Agriculture Appropriations Subcommittee.
    It very well may be that FDA lacks the resources to adequately 
inspect pet food facilities and imported products. And this is an area, 
Mr. Chairman, where we could work together to make a direct impact.
    However, we also should examine whether this is a management issue. 
In its response letter, the FDA says it has not determined whether 
changes in current law or resources are necessary based on the pet food 
recall. I find it mind-boggling that this agency always refuses to even 
consider requesting additional authorities or resources to help it do 
its job. As we all know, that is unheard of in Washington.
    The FDA likes to demonstrate its commitment to food safety by 
pointing out that ``food'' is the first word in its name. However, its 
actions suggest otherwise, highlighting the need for legislation that 
would create a single food safety agency--a bill that Senator Durbin 
and I have worked on for quite a long time now, Mr. Chairman.
    I look forward to FDA's analysis of their oversight of pet food 
manufacturing facilities and the final report on the actions that the 
agency took once the crisis finally ends. I think it will play a key 
role as we determine the best steps to take in moving forward.
    Thank you again, Mr. Chairman for allowing me to present testimony 
at this hearing and I look forward to continuing to work with you on 
this issue.

                         CONCLUSION OF HEARING

    Senator Kohl. Well, we thank you all for being here today. 
This is obviously a really important topic. It's very timely 
and something of concern to people all across our country. And 
your coming here today has helped us a lot to shine the light 
on the problem, and also, hopefully, to look for answers and 
solutions as quickly as possible.
    Thank you so much.
    [Whereupon, at 4:01 p.m., Thursday, April 12, the hearing 
was concluded, and the subcommittee was recessed, to reconvene 
subject to the call of the Chair.]

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