[Senate Hearing 110-172]
[From the U.S. Government Publishing Office]
S. Hrg. 110-172
EXAMINE THE CURRENT PET FOOD RECALL
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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
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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
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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
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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
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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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