[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]





 
                    PET TREATS AND PROCESSED CHICKEN FROM
            CHINA: CONCERNS FOR AMERICAN CONSUMERS AND PETS

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

                                HEARING

                               BEFORE THE 

              CONGRESSIONAL-EXECUTIVE COMMISSION ON CHINA

                    ONE HUNDRED THIRTEENTH CONGRESS

                             SECOND SESSION

                               __________

                             JUNE 17, 2014

                               __________

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              CONGRESSIONAL-EXECUTIVE COMMISSION ON CHINA

                    LEGISLATIVE BRANCH COMMISSIONERS

Senate

                                     House

SHERROD BROWN, Ohio, Chairman        CHRIS SMITH, New Jersey, 
CARL LEVIN, Michigan                 Cochairman
DIANNE FEINSTEIN, California         FRANK WOLF, Virginia
JEFF MERKLEY, Oregon                 ROBERT PITTENGER, North Carolina
                                     MARK MEADOWS, North Carolina
                                     TIM WALZ, Minnesota
                                     MARCY KAPTUR, Ohio
                                     MICHAEL HONDA, California

                     EXECUTIVE BRANCH COMMISSIONERS

              NISHA DESAI BISWAL, U.S. Department of State

                    Lawrence T. Liu, Staff Director

                 Paul B. Protic, Deputy Staff Director

                                  (ii)
                             CO N T E N T S

                              ----------                              

                               Statements

                                                                   Page
Opening Statement of Hon. Sherrod Brown, a U.S. Senator from 
  Ohio; Chairman, Congressional-Executive Commission on China....     1
Smith, Hon. Christopher, a U.S. Representative from New Jersey; 
  Cochairman, Congressional-Executive Commission on China........     2
Engeljohn, Daniel L., Assistant Administrator, Office of Field 
  Operations, Food Safety and Inspection Service, U.S. Department 
  of Agriculture.................................................     5
Forfa, Tracey, Deputy Director, Center for Veterinary Medicine, 
  Food and Drug Administration...................................     7
Kennedy, Shaun, Director, Food System Institute, LLC; Adjunct 
  Associate Professor, Department of Veterinary Population 
  Medicine, College of Veterinary Medicine, University of 
  Minnesota......................................................    24
Lovera, Patty, Assistant Director, Food & Water Watch............    26
D'Urso, Christopher J., Graduating Senior, Law & Public Service 
  Learning Center, Colts Neck High School, Colts Neck, NJ........    28

                                APPENDIX
                          Prepared Statements

Engeljohn, Daniel L..............................................    40
Forfa, Tracey....................................................    41
Kennedy, Shaun...................................................    45
Lovera, Patty....................................................    49
D'Urso, Christopher J............................................    61

Brown, Hon. Sherrod..............................................    64
Smith, Hon. Christopher Smith....................................    66

                       Submission for the Record

Testimony Submitted for the Record by Terry Safranek, 
  Representing Animal Parents Against Pet Treats Made in China...    66

                  Questions and Answers for the Record

Forfa, Tracey....................................................    69


                 PET TREATS AND PROCESSED CHICKEN FROM



            CHINA: CONCERNS FOR AMERICAN CONSUMERS AND PETS

                              ----------                             
TUESDAY, JUNE 17, 2014




                            Congressional-Executive
                                       Commission on China,
                                                    Washington, DC.
    The hearing was convened, pursuant to notice, at 3:38 p.m., 
in room 562 Dirksen Senate Office Building, Senator Sherrod 
Brown, Chairman, presiding.
    Also present: Representative Christopher Smith.

 OPENING STATEMENT OF HON. SHERROD BROWN, A U.S. SENATOR FROM 
  OHIO; CHAIRMAN, CONGRESSIONAL-EXECUTIVE COMMISSION ON CHINA

    Chairman Brown. I call this hearing to order.
    Thank you, Mr. Engeljohn, Ms. Forfa. I will introduce you 
in a moment. Thank you for joining us. I thank my Cochair, 
Congressman Smith, for being here and for his interest always 
in these issues that are important to our country on so many 
different levels.
    I'll do a brief opening statement and turn it to 
Congressman Smith, then we will proceed with the witnesses.
    I called this hearing to seek answers for American 
consumers, pet owners, farmers, and parents about the safety of 
pet treats and processed chicken and animal feed from the 
People's Republic of China. Americans want to know where their 
food comes from and want to make sure that everything is being 
done to keep it safe.
    Sixty-two million households in this country have a pet. We 
raise 83 million dogs, 96 million cats. Many of us raise our 
animals almost like members of our families. That's why it's so 
troubling that we still do not know, seven years in, if you 
will, what's causing the deaths and illnesses of thousands of 
dogs.
    Just last month, the U.S. Food and Drug Administration 
[FDA] said the reports of illnesses had increased to 5,600 
pets, including 1,000 dog deaths and now 3 human illnesses. 
While no cause has been identified despite extensive studies, 
the illnesses may be linked to pet treats from China.
    Days later, major pet stores, Petco and PetSmart, announced 
they would be phasing out the sale of pet treats from China 
because of safety concerns they have and their customers have. 
Many of us remember the pet food scare and recalls of 2007, a 
result of melamine-tainted pet food from China.
    Given this, pet owners in Ohio and across America are 
rightfully concerned when they go to the store to buy treats 
and food for their pet. They face a difficult and confusing 
question, just like the ones our family faces for our dog, 
Franklin. If something says it's made in China, can we be 
assured that it's safe? If it says ``Made in the USA,'' what 
exactly does that mean? Is everything being done to keep pet 
treats safe?
    Last year, the U.S. Department of Agriculture [USDA] 
declared that China is eligible to export processed cooked 
chicken to the United States, paving the way for chicken 
sourced in the United States to be shipped to China for 
processing and sold back to American consumers.
    While no chicken has entered our shores yet, it's possible 
that very soon this processed chicken could end up on our 
dinner tables and in our school lunchrooms. Can we just trust 
our Chinese counterparts to enforce safety up to our own 
standards given China's poor enforcement of their own laws and 
rampant corruption?
    We know what we have learned over the last 100 years in our 
country, to rely on the regulatory system to produce safe food, 
safe drinking water, clean air, all other kinds of safe 
ingredients in our pharmaceutical system because we know that 
the role of government and consumer protection is so important 
and Americans by and large trust their government to do that. 
Will the label clearly indicate that the chicken was processed 
in China in some cases so Americans can make an informed 
choice?
    Finally, researchers are exploring a possible link between 
animal feed from China and the PEDv virus that has wiped out 
some 10 percent of our pig population. It's been a year and no 
definitive cause has been identified. Americans want and 
require better answers and clearer labels and the peace of mind 
that the foods we import from China are safe.
    I appreciate the FDA and USDA being here to shed more light 
on these issues to help American consumers better understand 
them. In the meantime, I urge the Chinese Government to fully 
cooperate with our agencies and to make significant 
improvements in their food safety system.
    I urge our FDA and USDA to continue devoting every effort 
in determining the cause of the pet illnesses and PEDv. I urge 
companies to ensure the highest safety standards and to put pet 
and human safety first. Finally, I would urge us in Congress to 
consider whether we need to update our own labeling 
requirements to take into account an increasingly globalized 
marketplace and supply chain and to ensure the public health of 
our citizens.
    Congressman Smith, welcome.

STATEMENT OF HON. CHRISTOPHER SMITH, A U.S. REPRESENTATIVE FROM 
 NEW JERSEY; COCHAIRMAN, CONGRESSIONAL-EXECUTIVE COMMISSION ON 
                             CHINA

    Representative Smith. Thank you very much, Chairman Brown. 
Thank you for calling this important hearing. I want to welcome 
our distinguished witnesses to this hearing on the important 
issue of the safety of our food products from China.
    This is the second hearing on food safety that the 
Commission has done in the past year, and I especially want to 
thank Chairman Brown and our very dedicated and professional 
staff for their work to raise awareness about this issue, as 
well as all other human rights, rule of law, and governance 
issues.
    The safety of food, feed, and drugs from China is a cause 
of real concern. American consumers are rightly anxious. We 
have pet treats that may have sickened and/or killed many pets 
across America. A virus may decimate 10 percent of American 
pigs, possibly from vitamins or feed from China. We have food 
products, including processed chicken, that may not have 
labeled as being made in China. In fact, it may have been 
labeled ``Made in America.''
    I want to thank Chris D'Urso for bringing this last issue 
to my attention. The maze of labels and labeling requirements 
called ``Country of Origin Labeling'' [COOL] makes it difficult 
for American consumers to make reasoned choices about the foods 
they eat and those foods that they feed to their pets.
    Christopher D'Urso is one of the most outstanding young men 
that I have encountered. Not only did he achieve a perfect SAT 
score and ranked number one in his class, but his record of 
public service at such a young age is extraordinarily rare.
    Last year we met and he brought information to me and to my 
staff, and to the Commission staff, about his research and 
findings regarding Origin of Labeling laws for the United 
States. The thoroughness and the level of understanding in such 
a complex and international issue was indeed impressive.
    Having researched this issue since 2012, he pointed to the 
inadequacies of many of our current laws. In fact, consumers 
have the right to know the country of origin of products, 
especially when they eat those products. I believe his future 
contributions will be significant.
    On the issue of food safety, both Chinese and American 
consumers share serious concerns about food products made in 
China. I know I look, but again, we don't always know that what 
we're looking at is actually the truth. We really hope there 
can be more cooperation, accountability, and transparency in 
the future.
    This past week was Food Safety Awareness Week in China. 
China's food industry has faced a real crisis of confidence 
over the past seven years. Despite government efforts, the 
number of scandals continue to grow: Meat that glows in the 
dark; exploding watermelons; 40 tons of bean sprouts containing 
antibiotics; rice contaminated with heavy metals; mushrooms 
soaked with bleach; and pork so filled with stimulants that 
athletes were told not to eat them, because they would test 
positive for banned substances. All on top of the melamine-
tainted milk powder that sickened some 300,000 children in 
2007. As we all know, the World Health Organization [WHO] has 
said that melamine can cause kidney failure, bladder and kidney 
stones, and even may be a carcinogen.
    In response to that scandal, China passed its first ever 
food safety law. Nevertheless, we all know well that there is 
often a gap between what Chinese law says and what is enforced. 
China is still struggling to keep its food supply healthy.
    The Chinese Government is trying to crack down, we are 
told, recently closing some 5,000 food-producing businesses and 
arresting over 2,000 people. But experts on food safety say a 
needlessly complex bureaucracy and fierce determination to turn 
a profit means there will continue to be food safety scares and 
a Chinese public wary about its own supply.
    While we think that this issue would have been solved 
already if China transferred resources to food safety from 
censoring the Internet and cracking down on free speech and 
political dissent. Unfortunately, the government still seems to 
want safe pork but a silent public.
    There is a direct connection between better human rights 
conditions in China and food safety. While China has had 
unprecedented economic growth for decades, it lags behind in 
ensuring the rights of its citizens and in developing 
transparency, official accountability and rule of law, things 
it certainly needs to tackle like the issue of food safety.
    Transparency is absolutely necessary for any government to 
protect the health and well-being of citizens and to 
effectively manage problems related to food and drug safety. 
Remember the secrecy about the SAARS? Free speech and free 
press and freedom of association would allow crusading 
journalists in civil society to expose health scandals and work 
toward open solutions.
    Those who try to skirt the law for profit would be exposed 
and citizens could work together with their government to 
ensure better and healthier food and water. A free press and 
muckraking journalists and novelists like Upton Sinclair--who 
we all recall wrote ``The Jungle'' about unsanitary meat, and 
it led to the Pure Food and Drug Act of 1906, that eventually 
morphed through legislation into the FDA--certainly helped to 
bring better food safety to the United States.
    It may be tempting to say that China is on a learning curve 
that will eventually produce better food safety. But they need 
journalists, they need people who can speak out, use the 
Internet, and expose what is happening.
    Let me conclude by saying U.S. trade policy must put health 
and safety of U.S. consumers and their pets as its top 
priority. Safety before profits is the message that has to be 
sent to producers, processors, and manufacturers.
    If U.S. inspections are blocked or delayed for any reason, 
we should consider swiftly pulling products from shelves. In 
addition, the United States must tell authorities in China that 
they are held accountable for implementing and enforcing laws 
on food and drug safety.
    The United States should be negotiating as part of its 
diplomatic relations better and smarter inspections, again, 
transparency in the food and drug supply chain, and closer 
collaboration between our food safety experts. Our labeling of 
food and feed products must be clear so that consumers know 
what they are buying and from whom, and where it comes from.
    Last, the United States must continue to make human rights 
a top priority of U.S.-China relations, free speech, and an 
active civil society will do much more to ensure safer food and 
expose corruption.
    I yield back, and I thank you.
    Chairman Brown. Thank you, Congressman Smith.
    Dr. Daniel Engeljohn is the Assistant Administrator at the 
Food Safety and Inspection Service, Office of Field Operations, 
U.S. Department of Agriculture, responsible for oversight of 
the risk management policies for food safety and animal welfare 
conducted by nearly 7,800 employees and approximately 6,000 
meat and poultry processing and import facilities. He served as 
scientific spokesperson on food safety strategies. Dr. 
Engeljohn, welcome.
    Tracy Forfa is the Deputy Director of the Center for 
Veterinary Medicine at the Food and Drug Administration. The 
center regulates the manufacture and distribution of drugs and 
food additives given to animals, both food derived and 
companion. She's been with the Center for Veterinary Medicine 
since 2002. Prior to her appointment, she helped support FDA's 
mission for working on external dispute resolution to blood 
banking.
    She is a graduate of Wooster College, just 30 miles from 
where I grew up. Ms. Forfa, thank you for joining us.
    Dr. Engeljohn, if you would present your testimony. Thank 
you.

      STATEMENT OF DANIEL L. ENGELJOHN, PH.D., ASSISTANT 
  ADMINISTRATOR, OFFICE OF FIELD OPERATIONS, FOOD SAFETY AND 
       INSPECTION SERVICE, U.S. DEPARTMENT OF AGRICULTURE

    Mr. Engeljohn. Thank you, Chairman Brown and Cochairman 
Smith, members of the Commission. I am Dr. Daniel Engeljohn 
with the USDA's Food Safety Inspection Service [FSIS], Office 
of Field Operations. I am pleased to appear before you today to 
explain the current state of U.S. regulatory oversight of 
poultry exported from the People's Republic of China for human 
food.
    Let me take some time to explain FSIS's mandate. By law, 
FSIS is required to examine and inspect all slaughtered and 
processed livestock and poultry, as well as all processed egg 
products produced for use in commerce for human consumption.
    Our inspectors and veterinarians monitor the health of the 
animals brought to slaughter and ensure that livestock are 
treated humanely. They are also responsible for collecting the 
samples that our scientists analyze for the presence of 
pathogens and illegal drug residues.
    These dedicated men and women are on the front lines 
nationwide, ensuring that the regulations and directives are 
backed by scientific evidence to ensure that meat, poultry, and 
processed egg products in commerce are safe and wholesome.
    FSIS also regulates all imported meat, poultry, and 
processed egg products intended for use as human food through a 
three-step process. First, before FSIS-regulated products can 
enter the country, the agency determines whether the food 
safety regulatory system of any country that wishes to export 
to the United States is equivalent to our own inspection 
system. Second, once FSIS finds a foreign system to be 
equivalent, FSIS then re-inspects eligible product from that 
country at U.S. points of entry.
    During fiscal year 2013, FSIS personnel inspected 
approximately 3 billion pounds of meat and poultry products 
presented for import from 28 actively exporting foreign 
countries, as well as about 10 million pounds of processed egg 
products. Third, FSIS evaluates an exporting country's food 
safety system on an ongoing basis. Each year, FSIS reviews any 
changes in the foreign country's food safety system.
    Let me now explain, briefly, where we are in the process 
for China, a process that began in 2004 and, with their request 
for on-site FSIS audits, we began the process for looking at 
poultry processing and slaughter in their system.
    First, the United States is not importing any chicken that 
was slaughtered in China. The March 2013 audit by FSIS found 
that China's poultry slaughter system was not equivalent to 
that of the United States.
    Then second, FSIS reaffirmed in August 2013 that China's 
poultry processing inspection system is equivalent to that in 
the United States. This means that chickens slaughtered here in 
the United States or in another country whose poultry system is 
equivalent to that in the United States could be sent to China 
for processing and then re-exported to the United States.
    The only chicken currently permitted to be imported from 
China is processed chicken from approved sources. FSIS, in 
coordination with USDA's Animal and Plant Health Inspection 
Service [APHIS], also currently requires that all processed 
chicken products from China be fully cooked.
    China has provided a list of four plants it has certified 
as eligible to export processed chicken to the United States. 
However, before any processed chicken can be exported to the 
United States, a proper export health certificate must be 
developed by China and approved by FSIS and APHIS.
    This certificate must demonstrate that the poultry is 
sourced from the United States or from another country that has 
an equivalent system as in the United States, and then must 
also certify that the poultry was cooked to a proper 
temperature, among other things.
    We received a draft of this certificate earlier this month 
and, when it is approved, China will then be able to determine 
when to begin shipping products from plants certified to export 
processed poultry to the United States.
    The agency does not have any information about how much 
processed poultry, if any, is expected to ship from China once 
certification is up and running. In addition to carrying out a 
proper certificate, a product must be properly labeled.
    We are well aware of the consumer concerns regarding this 
matter. Under Title 9 of the Code of Federal Regulations, 
immediate containers of poultry products imported into the 
United States must bear labels showing the name of the country 
of origin.
    Because processed poultry product from China must be 
cooked, FSIS believes that it is unlikely that the product 
would be repacked or further processed in this country, 
therefore, we believe that consumers would likely be able to 
determine from the label that they are purchasing product from 
China.
    If the product were to be repacked or further processed in 
the United States, it would not include information that such 
product was from China but it would be repacked or processed 
under FSIS inspection.
    The dedicated men and women of FSIS work every day for a 
common and extremely important goal of preventing food-borne 
illness. We take our mission seriously and understand the 
important role of ensuring the safety of the nation's food 
supply, whether domestic or from foreign establishments.
    Thank you for your continued support and the opportunity to 
report on the work we do to protect public health.
    Chairman Brown. Thank you, Dr. Engeljohn.
    Ms. Forfa, welcome.

 STATEMENT OF TRACEY FORFA, J.D., DEPUTY DIRECTOR, CENTER FOR 
     VETERINARY MEDICINE, U.S. FOOD AND DRUG ADMINISTRATION

    Ms. Forfa. Good afternoon, again. Chairman Brown, 
Cochairman Smith, thank you. I am Tracey Forfa, Deputy Director 
of the Center for Veterinary Medicine at the Food and Drug 
Administration [FDA], and I really appreciate the opportunity 
to be here today to update you on FDA's investigation into 
reported illnesses in pets that have consumed jerky pet treats.
    As of last month, we had received approximately 4,800 such 
reports, including 1,800 since we did an update in October of 
last year. The reports received involved illnesses in more than 
5,600 dogs, 24 cats, 3 humans, and sadly, involved more than 
1,000 canine deaths. Most of the reported cases involved 
chicken, duck, or sweet potato jerky products imported from 
China.
    Unfortunately, to date FDA has not been able to identify a 
specific cause for the reported illnesses or deaths, despite an 
intensive scientific investigation. Getting to the bottom of 
this problem is definitely a priority for FDA and the agency is 
continuing its comprehensive investigation.
    This ongoing global investigation is complex and involves a 
wide variety of experts. We have collaborated with our 
colleagues in academia and industry, and have reached out to 
the pet firms in the United States to enlist their help and 
share data with them.
    We are updating veterinarians and pet owners as we receive 
information on our Web site, and we have a Web page dedicated 
specifically to issues related to jerky pet treats.
    Our last major update, as you know, was last month. This 
information has been further disseminated to veterinarians by 
various groups, including the American Veterinary Medical 
Association.
    The 4,800 reports that we have received cover many sizes 
and ages of dogs and include multiple breeds. About 60 percent 
of the reports we receive are for gastrointestinal illnesses 
and about 30 percent relate to kidney or urinary issues. The 
remaining 10 percent of cases involve a variety of other 
symptoms, including convulsions, tremors, hives, and skin 
irritation.
    We had a surge of complaints after we published, in October 
of last year, an update. The agency has determined that about 
25 percent of those 1,800 cases were historic, which means 
illnesses occurred several months or even years previously. The 
remaining cases were more recent, but may or may not have 
received veterinary attention.
    Of the new cases that we have received since October, we 
have identified about 125 well-documented cases which we are 
further investigating. We continue to correspond with owners 
and veterinarians of these pets to track their progress and 
obtain test samples when they're available.
    We also are working with state and university diagnostic 
laboratories to collect 250 jerky treat samples that are 
connected to consumer-related complaints, plus more than 200 
retail samples that we've obtained on our own, and we've 
performed more than 1,000 tests on these samples.
    This has included intensive testing for numerous 
contaminants, as well as examining composition of jerky pet 
treats to verify that they actually do contain the ingredients 
listed on the label and do not contain ingredients that are not 
listed.
    In addition to this work, we have held regular meetings 
with the Chinese Administration of Quality, Supervision, 
Inspection, and Quarantine [AQSIQ] about the jerky pet treat 
issue.
    In April 2012, we conducted inspections of several 
facilities in China that manufacture jerky pet treats for 
export. We selected these firms specifically because the jerky 
products they manufacture were associated with the highest 
number of reports of pet illnesses.
    These inspections provided valuable information on these 
firms' jerky pet treat manufacturing operations, including 
ingredients, raw materials, as well as manufacturing equipment, 
heat treatment, packaging, quality control, sanitation, and 
product testing.
    Although these inspections helped identify additional areas 
for investigation, we found no evidence indicating that these 
firms' jerky pet treats are associated with illnesses.
    As a follow-up to those inspections we sent a delegation to 
China to express our concerns about the complaints we continue 
to receive. As a result, FDA and Chinese authorities agreed to 
expand investigation of jerky pet treats.
    In addition to sharing our epidemiological findings, we 
have initiated a scientific collaboration with the Chinese and 
have taken other steps to identify the root cause of the 
illnesses. We also have hosted Chinese scientists at our 
veterinary research facility to further scientific cooperation.
    Thank you again for this opportunity to describe our 
ongoing efforts to determine a definitive cause. If our 
investigation leads to identification of any particular jerky 
pet treat ingredient or contaminant that is associated with 
these illnesses, we intend to act quickly to notify the public 
and take steps as appropriate to ensure that these affected 
products are promptly removed from the market.
    In the meantime, we encourage consumers to continue to 
check our Web site for updates and we continue to remind pet 
owners that jerky pet treats are not necessary for a pet's 
healthy diet, so eliminating them will not harm pets since 
commercially produced pet food contains all the ingredients 
that pets need.
    Thank you very much again for having me today.
    Chairman Brown. Thank you, Ms. Forfa, very much.
    My first set of questions will go to Dr. Engeljohn and then 
I'll turn it over to Congressman Smith. Then my second round 
will be with Ms. Forfa.
    I think the American public is pretty confused about what 
labels mean and what exactly does ``Made in the USA'' mean; 
what does it mean when there is no country-of-origin label on a 
product? Let me get to that in a second.
    It appears the assertion of processed chicken being labeled 
as from China hinges on the assumption that it has to be cooked 
in China, and cooked chicken coming over from China is not 
likely to be repackaged or further processed here in the United 
States.
    So my question is this. This box of chicken mac-and-cheese 
says it's a product--this one says ``Made in USA.'' This says 
``Made in the USA.'' The question is, is it possible that 
cooked chicken from China could end up--and this one doesn't 
say any country of origin, correct? This one has no country of 
origin.
    So does this, if it says ``Made in USA,'' mean always that 
the chicken was neither raw chicken nor--well, does it mean 
it's neither raw chicken nor packaged chicken nor processed 
chicken coming from China? If it says ``Made in the USA,'' can 
you be confident that it wasn't here, then sent back to China, 
then here or does this always mean the supply chain is entirely 
made in the United States, it's entirely within the United 
States?
    Mr. Engeljohn. Okay. So thank you for the question. On 
issues related to the meat or poultry products that you 
referenced, without looking at that box, I'm not real sure if 
that's a product that is regulated by my agency, from the 
perspective that if there's more than 2 percent poultry in 
that, as an example, then it would be regulated by my agency.
    But on the issue of COOL, if it's a COOL-related policy, 
then that would be a policy that is administered by the 
Agricultural Marketing Service at USDA and not my agency. But 
the products that are contained within that statutory provision 
would be for covered commodities, which are generally just 
whole muscle cuts and ground meat. So with regard to processed 
meat products, they would not be covered by the COOL-related 
labeling to begin with.
    In terms of voluntary labeling in terms of what that would 
mean, we don't have criteria that we use to set a basis for 
made in the United States.
    Chairman Brown. So what does that mean in terms of, if 
someone goes to the store and gets this chicken mac-and-cheese 
and it does say USDA on it, inspected, does this mean when I 
buy this at the local Heinen's in Cleveland that I will know 
that none of this came from China, that none of it was either 
processed in China or the raw chicken came from China? It 
sounds from your answer that I don't have, and you don't have, 
confidence that that's the case.
    Mr. Engeljohn. Yes. I don't believe that that statement 
would fully cover the issue of product that may have come in, 
that may be a small portion that might be contained within that 
overall product.
    Chairman Brown. So what's the use of a product that says 
``Product of USA? '' What's the use of that kind of label? What 
does that label tell us then?
    Mr. Engeljohn. Yes. I think on a product such as that it 
would be the majority of ingredients in there would be from 
confirmed sources that were either slaughtered or processed 
within the United States. So it would be a majority, but I 
don't believe that you could identify that there would be no 
ingredients from another country, particularly if it was from 
another country that had an equivalent system because once it 
comes into the domestic system it becomes a U.S. product.
    Chairman Brown. Equivalent USDA/FDA regimen of consumer 
protection.
    Mr. Engeljohn. Yes.
    Chairman Brown. Okay. Of food safety.
    This box, which is chicken fettucine, has no country of 
origin label at all. What does that tell the consumer when she 
or he sees that?
    Mr. Engeljohn. Again, in terms of--if it's a question about 
whether or not the----
    Chairman Brown. Excuse me. It presumably has well over 2 
percent of the ingredients that are chicken.
    Mr. Engeljohn. Right. So the COOL labeling, the country of 
origin labeling, would not be applicable to a product such as 
that. Again, for the meat products that would be covered, it 
would be whole-muscle cuts or ground products, they would not 
be processed products. So in this case, that would contain a 
mixture of processed products.
    Chairman Brown. I mean, the issue I'm trying to get at is 
not what technically falls in the jurisdiction of FDA or USDA 
or some other regulatory body. The question is what message 
does it send to American consumers about our food safety 
system? The question about the chicken mac-and-cheese, you talk 
about just the whole issue of how much or what percent of 
imported--perhaps imported chicken, processed chicken, might 
have.
    We know from several years ago most of the drug heparin 
came from U.S. sources, but there were contaminants that came 
from China that caused people to die. So the percentages, while 
they may matter in statute and they may matter to regulators 
and to Members of the House or Senate perhaps, ultimately if 
they contaminate the food that someone ingests, that's 
fundamentally the issue.
    So go back to this chicken fettucine, since there's no 
country of origin labeling. What would you suggest we do on 
something like this?
    Mr. Engeljohn. So on products such as that--and again, the 
manufacturer of that product can choose whether or not they put 
in place a control program for the source ingredients that 
would be used in that product.
    If they had the type of evidence to demonstrate that the 
source could be verified through a third party, as an example, 
a claim such as ``Made in the USA'' or some specific artifact 
such as that on the label then could be verified and that could 
be on the label.
    Without there being a designation on that product, it could 
simply mean that the manufacturer did not source those 
materials and have verification for it, so it may or may not be 
completely from a product that is slaughtered, produced, and 
processed within the United States. It really does matter 
whether or not in this case the manufacturer has chosen to use 
ingredients and then seek a labeling claim for that.
    At USDA, for the labeling of that product, it's a prior 
approval system for which we will look for the evidence that 
the manufacturer would submit to verify whether or not the 
ingredients are, in fact, verifiable.
    Chairman Brown. You spoke of equivalency of other food 
safety regulatory systems. I think most Americans would have 
confidence in a product processed in Canada because I think 
most Americans, or a number of Americans actually go to Canada 
to buy their prescription drugs, for instance, believing that 
the Canadian system of FDA, of regulatory safety for 
pharmaceuticals, is more or less equivalent to ours.
    Understanding that, I wanted to ask about the audit that 
found China's poultry processing inspections system equivalent 
to ours in light of China's well-documented poor food safety 
record and corruption problems.
    In terms of the audit that USDA conducted to make this 
determination, talk to us about how rigorous it was, how we can 
be assured that Chinese officials played it straight during 
that audit process.
    Mr. Engeljohn. So, thank you on that question related to 
the audits. Actually, there were multiple audits that we 
conducted in China over the course of several years, originally 
back in 2004 when we started the process, and then again when 
we more recently reaffirmed that process.
    As I had mentioned, we do rely upon the documentation the 
country submits to us to demonstrate that they have laws and 
regulations in place that are equivalent to the laws and 
regulations that we have at USDA for the products we regulate 
domestically. That's the first stage.
    The second stage would be an actual on-site audit of their 
system where we would send auditors from the United States into 
the facilities that China would elect to demonstrate that their 
system is set up to be able to produce product in an equivalent 
manner as we do in the United States.
    So our auditors from the United States would be there for 
an extended period of time, observing the slaughter of the 
animals and the processing of the animals if it's a slaughter 
equivalence audit, or in the case where it was the processed 
products then it was to look to ensure that the ingredients 
that were being used from a poultry perspective were from the 
United States or from an approved source, and then observe the 
actual fabrication and processing of that product along with 
the records.
    With that, then they looked at the evidence that the 
country had for the microbiological tests and chemical tests 
that they would have conducted on that product. That serves as 
one basis in which we observed what is happening. We also 
assessed the laboratory procedures to ensure that their 
capability is such that they can discern the pathogens and 
chemical residues that we have a concern about.
    Once we determine that the country has demonstrated that 
they're able to meet our expectations, which is the case for 
China on processed poultry, then they go through the rulemaking 
process and add them to our Federal regulations. We're at that 
final stage now on the process side where we've gone back since 
there was a period of time in which China was not actively 
seeking an approval for equivalence and they administered a new 
food safety law.
    So we went back to reaffirm their process, that their new 
laws were still designed to meet the same equivalent outcome as 
what we have in the United States. So we observed, again. So 
that was another observation actually in the processing 
facilities where they were producing it.
    Chairman Brown. And I want to ask you about the equivalency 
of raw chicken in a minute. But are you confident then, do you 
have some certainty that you do those inspections, you go 
through the rulemaking process, you think they're doing their 
processing in an equivalent sort of way to the way we do it--
are you confident that without USDA, without ongoing USDA 
inspections and U.S. inspectors at the right places in China, 
at these facilities in China, that they will continue to meet 
those standards?
    Mr. Engeljohn. Yes. We're confident due to the process of 
our government relationship and our ongoing dialogue with the 
government officials that they're maintaining the inspection 
system that they in essence redesigned in order to meet the 
U.S. requirements.
    I would add that on top of that the FSIS import 
requirements would be that we do have a point of entry 
reinspection requirement in which 100 percent of the shipments 
that come in from China are reinspected for a variety of issues 
related to proper labeling, proper certificates, condition of 
the products, the box count, and that the labeling is proper.
    Then for new countries such as China that would be coming 
on board, we would have an intensified import reinspection 
where we would do more thorough inspections, including 
collecting samples for drug residues and for microbiological 
pathogens.
    So the combination of having evidence that they have an 
inspection system which they redesigned, which they would 
continuously provide us information about how well that system 
is operating and the evidence that they have to demonstrate 
that, as well as the evidence that they have of training their 
employees and maintaining the competence of that system, the 
re-inspection serves as an important check on whether or not we 
find issues of concern that then we would go back and follow up 
with China.
    So I think we have a system in place that has worked well 
for the 28 other countries that are actively exporting to this 
country and that process is ongoing. So once they had been 
deemed equivalent, we do have a process in place where we would 
reaffirm that over time.
    Chairman Brown. Let me switch to the raw chicken. As you 
noted, China was not granted equivalency status for its poultry 
slaughter system and cannot export, as a result, raw chicken to 
the United States, at least not yet. Is China requesting 
another audit? If so, when might that occur and how close was--
if you'd give us your thoughts on how close China was to 
equivalency. Where did they fall short and how difficult will 
it be for them to correct that?
    Mr. Engeljohn. So there are a couple of issues. I'll 
explain the process. The slaughter process, in and of itself, 
is one for which the domestic system for slaughter in China was 
different--considerably different--than it is for the domestic 
system in the United States.
    So the process in which the establishments that China 
identified for the agency to audit required them to modify 
substantially the procedures that they would be using there in 
order to have equivalent procedures.
    So I would say that the issues related to whether or not 
they're close to meeting our expectations for slaughter were, 
they were close to hitting the mark on that. We did respond 
with our concerns and they've responded back with their 
corrective measures for how they would address our concerns. 
They have not yet requested an audit for us to come back and 
look, although we expect that that would happen fairly soon.
    Once we would go back, and if we were to determine that 
they are in fact capable of having an equivalent system, then 
that would start our rulemaking process where we would go 
through the process of putting out a Federal Register proposed 
rule to add China to our list of countries deemed eligible to 
ship slaughtered poultry to the United States.
    Chairman Brown. Let me interrupt for a second. Does any 
country that gets on that list, the eligibility list if you 
will, ever get off it as a result of a changed practice or not 
living up to the standards that it committed to and promised 
and practiced?
    Mr. Engeljohn. What I would say is that there are countries 
that don't actively export, for reasons--either they've chosen 
because of the degree of difficulty or just the market access.
    Chairman Brown. If they continue to export, they continue 
to live up to that standard. At least that's been the evidence 
so far.
    Mr. Engeljohn. That's right. So if they're on the list, but 
if they've been off from the list for a period of time then we 
would go back and reaffirm our understanding about their 
system. But removing a country, we have not, to my knowledge, 
removed it completely.
    Chairman Brown. And I know I interrupted your answer, but I 
want to get to one thing. I've taken a lot of time and I want 
Congressman Smith to certainly have his time.
    If raw chicken from China is approved for export here, if 
you go through that process and you found equivalency, if it's 
exported from China and imported into the United States it's 
processed in the United States, what will the label say? Will 
it say country of origin China or will it say ``Made in the 
USA,'' or let's say neither of those things?
    Mr. Engeljohn. Okay. So I would like to just add that, in 
addition to the FSIS requirements for equivalency there is an 
animal health issue that has to be dealt with for our Animal 
and Plant Health Inspection Service, which at the moment is one 
of the reasons why poultry cannot be--even if FSIS were to move 
forward with this portion of the rulemaking, there's still the 
issue of dealing with the animal disease, and in this case 
avian influenza, that has to be addressed. It's the reason why 
cooked poultry only can come in from China.
    But having said that and if those issues were resolved, 
then if product coming in from China is a raw poultry product 
it would fit the expectations for a whole muscle cut that COOL 
regulations would define right now that would require labeling. 
But the fact that the product is produced in a certified 
establishment in China would also identify the establishment 
name and number on the product, so it would be identified as a 
product of China.
    Once that product then came into the United States and is 
put into the domestic system, if it didn't go directly to 
retail and was used as an ingredient in product that is being 
manufactured domestically, then it becomes domestic product and 
it would not bear the labeling of ``Made in China.''
    Chairman Brown. But I assume that you're comfortable with 
that because you are comfortable with the fact that the raw 
chicken at this point, once it's certified, is in fact 
equivalent and safe.
    Mr. Engeljohn. We move forward with our determination that 
there's an equivalent system and it's based upon a totality of 
information that we believe would, in fact, demonstrate that 
the country is capable of ongoing inspecting of that product 
and producing it safely to meet the expectations of the United 
States, then with our reinspection requirements, providing an 
added measure of looking for issues of concern.
    So if we had reason to believe that there were chemicals or 
drugs used on products that perhaps are not used in the United 
States, if we were aware of that, then we would likely build 
that into our re-inspection procedures at the port of entry and 
look for it there, as well as querying the government to 
provide us evidence as to whether or not there are drugs or 
other compounds used that likely are not deemed to be safe in 
the United States.
    Chairman Brown. Let me go a slightly different place then 
turn it over to Congressman Smith. You talked about facilities 
where there will be inspections for either the raw or processed 
chicken in China. I ran a hearing about five years ago on the 
sort of supply chain for pharmaceuticals in China and that the 
ingredients were made or the ingredients would often come from 
sort of mom-and-pop operations all over villages, all over this 
country of 1.3 billion people in an area more or less the size 
of the 48 contiguous states in the United States.
    What is the reach of this? Roughly how many facilities do 
you or would you inspect, would you need to inspect in China 
for either the processed or the raw chicken to make our food 
supply safe?
    Mr. Engeljohn. With regard to the FSIS equivalence process, 
we would be focused solely on the slaughter or processing 
facilities. So the other facilities producing other ingredients 
that might be used would not be part of the review of FSIS.
    However, what we would ask and have evidence from the 
Chinese Government for would be evidence that the ingredients 
to be used in the meat or poultry products, that we would find 
to be in line with export to the United States and would need 
to come from sources that are approved for food use and have in 
place, in essence, evidence to suggest and demonstrate that 
that ingredient is in fact safe for that use.
    Chairman Brown. So how many of those facilities are there, 
the slaughtering facilities?
    Mr. Engeljohn. Well, presently there are four 
establishments that China has identified that, if and when they 
begin exporting to the United States----
    Chairman Brown. All of it would come through those four?
    Mr. Engeljohn. They would only come from those four 
facilities at this time. Should China choose to put in place an 
inspection system in additional facilities, then they would 
identify what they have done to ensure that those facilities 
meet our expectations. FSIS then would have the opportunity, 
should we choose to go and conduct audits in those facilities, 
we certainly could do so, but we rely upon the government to 
tell us which facilities. But right now, only four.
    Chairman Brown. So those inspections at the place where you 
found equivalence with the food, but the processing, chicken 
processing, how many of those facilities are there? It's not 
those four. It would be different facilities, right?
    Mr. Engeljohn. Yes. China has a large number of 
establishments but they have only put forward four for which 
they have----
    Chairman Brown. For the raw chicken.
    Mr. Engeljohn. For the processing and----
    Chairman Brown. Oh. Processing and----
    Mr. Engeljohn. Yes.
    Chairman Brown. The processing and raw poultry.
    Mr. Engeljohn. For right now it's just processed poultry, 
is what we're focused upon because that's where they have, in 
fact, identified that they have put in place inspection systems 
demonstrated to meet our expectations.
    Chairman Brown. Okay. Okay. Thank you. Sorry I took so 
long.
    Representative Smith. Thank you very much, Mr. Chairman.
    Thank you for your testimony and for your insights. Let me 
just ask you, Dr. Engeljohn, how many of the other 28 countries 
are democracies, how many are dictatorships?
    Mr. Engeljohn. I'm sorry, I don't know the answer to that 
question.
    Representative Smith. Could you name some of the countries?
    Mr. Engeljohn. Certainly. So for the--I would just--are you 
interested in the countries that have approved sources for 
poultry, as an example, and others?
    Representative Smith. Primarily. What we're looking at is, 
and you've said it several times today, that we're relying on 
government. We rely on the government's documentation on site. 
When we're dealing with a democracy, obviously there's 
transparency, there's whistleblowers.
    I mean, what happens if a Chinese employee or someone 
anywhere in the chain of command over there blows the whistle? 
Does he or she go to jail or do they get a promotion? 
Whistleblowers are sometimes not well heeded anywhere else 
either, but they play an absolutely important role, and 
bloggers and journalists who also do whistleblowing. The people 
inside the factory or the slaughterhouse, what happens? Have 
there been any instances where there has been a whistleblower 
who is Chinese?
    Mr. Engeljohn. If I may, I'll answer the question about the 
countries eligible to ship poultry to the United States with 
equivalent systems that are actively doing so; so Canada, 
Chile, France, Great Britain, Hong Kong, and Israel. Then 
Australia and New Zealand are approved to do so, but only for 
ratites, so it's a very specific type of poultry. Then Mexico 
and China are the two presently that are listed in our 
regulations for processed poultry.
    Representative Smith. So from that list it would appear 
that the only dictatorship is China. As Chairman Brown and I 
and our Commission has documented, especially through the 
annual human rights report that comes out, the word of the 
Chinese Government is usually not trustworthy. I have found 
very few instances in my 44 years as a Member of Congress where 
I took on face value just about anything the government said, 
whether it be about political prisoners or any other situation.
    There's always, every time, laced in there a whole drill of 
misinformation and lies and deceit. If that's the modus 
operandi for how they deal with all things related to democracy 
and human rights, it's not a stretch to say if we rely on them 
for documentation, that's an Achilles heel that is huge. Would 
you agree?
    Mr. Engeljohn. Well, it does present a huge dilemma. I 
would say though that our on-site audits and our ongoing re-
inspection at ports of entry into the United States provide us 
additional levels of safety concerns that we can have oversight 
over, and then we do respond to the press.
    We respond to issues that we hear about of concern that 
might be ongoing anyplace around the world and in terms of 
whether or not we need to step up a particular re-inspection 
activity or we need to go back and conduct audits to 
investigate a particular issue.
    Representative Smith. When you do an audit, what kind of 
access do we have to the plant or the processing facility? Is 
it immediate or do we have to give advance notice? Is it 
unfettered? Do the people who go speak fluent Chinese? Are they 
able to talk to workers without that worker being retaliated 
against, or do we look at paper?
    Mr. Engeljohn. Okay. So we have reciprocal response between 
other countries coming to the United States and auditing our 
system versus us going to other countries, so we do have 
advanced notification when we are going there.
    Representative Smith. How far in advance?
    Mr. Engeljohn. Well, it's typically far enough in advance 
to be able to arrange travel, get visas, and those types of 
things approved. So we do have to go through that process for 
countries where visas are required.
    Representative Smith. How long does it usually take?
    Mr. Engeljohn. I would say usually 60 days in advance.
    Representative Smith. Sixty days?
    Mr. Engeljohn. In order to plan that type of audit or visit 
that we would need to make.
    Representative Smith. So if there is some compelling 
information, we don't have people either in the Embassy who 
will be mobilized immediately to go check this out or someone 
who could get there, get the visa for whatever reason, and just 
get there for an on-site inspection where you don't get a 
Potemkin Village?
    Mr. Engeljohn. So what I would say is we're fortunate in 
that, as an example, in China where we do have a presence, USDA 
does have a staff that is present there, interacting with the 
government, and does have access throughout the country.
    When we do go into a country we have translators with us 
and we do have access to the facilities as we would here. A 
facility that is receiving the grant of inspection is required 
to give us full access to all the records and presence whenever 
we need to be there.
    Representative Smith. Could the records be falsified that 
they get to look at?
    Mr. Engeljohn. They could be. They could be here as well. 
So our process is----
    Representative Smith. Well, here they can be prosecuted. 
Here they can be prosecuted in a court where the judicial 
system, despite its flaws, is above board.
    Mr. Engeljohn. Yes. And our auditors, as an example, when 
they do go and look at in-country as well as the documentation 
that we require the country to submit annually, are looking 
very thoroughly at the records to see whether or not there is 
the potential for evidence of falsification. Again, we do have 
some cross-checks in that we can test for microorganisms and 
pathogens in order to have additional confidence to what we 
would find.
    Representative Smith. How many inspectors and personnel are 
dedicated to these Chinese products? How many people are we 
talking about?
    Mr. Engeljohn. In China? I'm sorry.
    Representative Smith. No, for the whole--your operation. 
How often do they actually get deployed to China to do 
inspections?
    Mr. Engeljohn. Okay. Generally speaking, again, we have a 
presence. The U.S. Department of Agriculture [USDA] has a 
presence there in terms of permanent staff that is located in-
country, and APHIS, our sister agency at USDA, as well has a 
staff there. When FSIS sends a team in-country it's usually a 
team perhaps of 6 to 10 individuals, all with differing 
expertise, whether it be microbiology, veterinary medicine, 
epidemiology, policy, those types of things.
    So it's a team of diverse subject matter experts that are 
there for an extended period of time. They are with translators 
who will be translating for the U.S. Government, not Chinese 
employees but U.S. Government-sanctioned interpreters.
    Representative Smith. Has there ever been a situation where 
you didn't have enough people in the pool where the 6 to 10 
were deployed and others had to wait in order to do an 
inspection or did you get that few of requests.
    Mr. Engeljohn. An agency such as ours with roughly 7,800 
employees and very dedicated staff of professionals, we have 
the resources that we need to put it together.
    Representative Smith. So the pull-down in personnel comes 
from that larger group?
    Mr. Engeljohn. That's right.
    Representative Smith. Do they have specialized training in 
dealing with audits that could be easily falsified?
    Mr. Engeljohn. Yes. Our auditors are specifically trained 
as auditors. Then the subject matter experts that join them are 
there with their subject matter expertise.
    Representative Smith. Well, I raise this in part because 
even when we were talking about groups like Apple Computer, 
auditors were paid to falsify and then to give a clean bill of 
health to the corporation that everything's just fine, gulag 
labor, slave labor type conditions are not occurring when 
certain products are being made. I mean, this is the land of 
disinformation.
    Unless somebody is very adept at looking and asking--and 
again, maybe you did answer it even here, but do you know of 
any instance where a whistleblower came forward who happened to 
be a Chinese man or woman, who came forward and said this 
product is adulterated, this, if you will, Omega-3 fish oil is 
nothing but adulterated, this honey has been filled with 
something other than honey even though it says Grade A Clover, 
or whatever. Do you have any instance where whistleblowers came 
forward?
    Mr. Engeljohn. Not for issues relating to FSIS products, 
no.
    Representative Smith. If you hear of something, if you 
could let us know because it would be nice to know what happens 
to that person. Do they get prosecuted, taken out in the back 
and put into a van? Because again, this is a dictatorship. I 
can't stress that enough, in terms of my sense.
    I mean, I am working on the whole false solution that when 
we're talking about gulag labor we started with Bush One, 
carried into Clinton, carried right up to this day where 
Customs would be able to check out whether or not something was 
being made with gulag labor, which we know it does.
    I was actually in Beijing Prison Number 1 right after 
Tiananmen Square in 1991, so a couple of years later, and they 
were making Jellies socks and shoes for export. And only 
because we literally took with us the Jellies socks were we 
able to get an import ban on those gulag-made goods.
    I'm sure the records were great. That stuff was showing up 
all over in the United States. Jellies shoes were big for 
little girls at the time. But only because we had--we have 
Customs people who are supposed to be doing this and they're 
like the Maytag repairman.
    So if it happens in this realm, I don't know why it 
wouldn't happen in the food or the pet realm where there are 
huge profits to be made if you can cut corners, and corruption 
obviously moves higher in dictatorships than it does when you 
have checks and balances. So, just some thoughts on that.
    Let me ask you, if I could, Mr. Assistant Administrator, 
can any chicken processed in China end up in school lunches or 
other Federal meal programs? And would you clarify why the USDA 
believes that processed poultry from China would not be 
repackaged or further processed in the United States? And if 
any of it was, would it require labels saying ``Processed in 
China? ''
    Mr. Engeljohn. Okay. I would answer that. The questions on 
the school lunch program are handled by our Agricultural 
Marketing Service and our Food and Nutrition Service at USDA, 
so for more specific information we certainly can get 
information back to you on that.
    Representative Smith. Thank you, for the record.
    Mr. Engeljohn. But with regard to product requirements, I 
can tell you that for the National School Lunch Program, the 
Agricultural Marketing Service does buy only American product. 
So for that purpose, products sourced from China would not meet 
those expectations.
    The question though about, why do we believe product would 
likely not be repackaged, the issue being that product would be 
coming from the United States, Chile, or Canada, one of the 
approved countries to slaughter the poultry, go to China, be 
processed, come back here in consumer-ready packaging. So it 
would be coming back as cooked consumer-ready product.
    The likelihood of that being then taken and rounded up and 
added to other products domestically, we think, is a low 
likelihood. It could happen, but we think that that likely 
would not be the case. As such, that product would be available 
in the marketplace for the consumer to see that it is made in 
China.
    Representative Smith. I have one last question.
    Several years ago I chaired a landmark hearing on 
censorship on the Internet. We had Google, Microsoft, Cisco, 
and Yahoo! all testify. I swore them all in. They all said how 
they were just following the Chinese law, leaving it all up to 
the Chinese to tell us what they could censor and what they 
should not, and wouldn't tell any of us at the hearing what 
they were doing, words like the Dalai Lama and all the other 
things that were excised when you did a Google search, or any 
other search, there.
    The Internet is so heavily censored. How does a Chinese 
person--again, going back to this idea that, can we trust 
anything this government says? I wish we could. I really wish 
they were trading partners rather than adversaries, as they are 
around the world, particularly in Africa.
    So if you could, the Internet. If somebody went and blogged 
tomorrow that poultry processing plant A, B, or C is a huge 
problem and this is why, what would happen?
    Mr. Engeljohn. I did say--again, we're pre--given final 
approval in terms of moving forward with the equivalence 
process in China. But I think any information like that is what 
we do assess. We hear reports of issues of concern.
    If we knew that one of the facilities that was deemed to be 
certified by China was one of those plants that a consumer in 
China were to identify, it would cause us to look into and be 
concerned about that and likely be part of questions that we 
would ask the Chinese Government and then be part of an audit 
process if and when we do go back to China, which we would 
expect to do.
    Representative Smith. Thank you.
    Chairman Brown. Thank you. There is a vote expected at 4:45 
on our side, so I will ask Ms. Forfa questions for maybe 10 
minutes and then if you complete your discussion with her you 
can go to the next panel. But we'll work that out.
    Ms. Forfa, give us an update on PEDv and where you see it 
going, when you think you will know enough to get to the bottom 
of this? If you would just give us a progress update.
    Ms. Forfa. Sure. So we are continuing our investigation and 
we are working with our counterparts in the Canadian foods 
inspection authority as well as our counterparts at USDA, 
APHIS, on the investigation. I don't have any definitive idea 
when that investigation will be closed, but we do continue to 
pursue that actively.
    Chairman Brown. Okay. Do you feel like, as you've pursued 
this and figured this out and made some progress in doing that, 
is there a system in place to catch this in the future before 
something like this can happen?
    Ms. Forfa. Without knowing and certainly identifying a 
definitive cause of the outbreak--this particular virus was 
found in the 1970s in Britain, so it's been around for a while. 
My experts tell me that it is fairly widespread globally and so 
the investigation will be complex. So we just need to do a real 
scientific study and do some trace-back and figure out if we 
can identify the source.
    Chairman Brown. Let me talk about visas and FDA. My 
understanding is the FDA is increasing inspectors in China but 
that China is holding up visas for those inspectors. Vice 
President Biden brought this issue up with the Chinese in 
December. What kind of progress have we seen?
    Ms. Forfa. We have made progress. Things have been moving 
forward since Vice President Biden was there in December of 
last year. We are moving to get those visas in place and 
increase our presence in our China office, which we have found 
very helpful.
    Chairman Brown. Is the progress sufficient? Are you 
satisfied that you have gotten enough visas or are you just 
saying it's better than it was?
    Ms. Forfa. We are moving forward.
    Chairman Brown. Sounds like a fairly low bar that satisfies 
you.
    Ms. Forfa. I think we are encouraged by the progress that's 
being made.
    Chairman Brown. So it is a low bar. Okay.
    Talk about labor. This is a--got to love this product. It's 
called ``Happy Hips,'' and it's got glucosamine and chondroitin 
for your dog's joints, apparently. It says natural with added 
glucosamine, chondroitin, and vitamin E. No grain, corn, wheat, 
soy, or fillers. Treatment for adult dogs. American flag on it, 
``Made in the USA.''
    Now, given our current labeling laws, they can put this on 
here. My question is, could this also include a relatively 
small amount that includes vitamins or other additives from 
China and still put the label--slap the American flag on there 
and say ``Made in the USA? ''
    Ms. Forfa. We don't have primary labeling authority for 
country of origin, that's Customs and Border Protection that 
actually has the primary requirement for labeling. We require 
that manufacturers put on their labeling the ingredients and 
then the name and their place of business.
    Chairman Brown. So there is some traceability there.
    Ms. Forfa. Yes.
    Chairman Brown. And if someone from that agency were 
sitting in that third chair, would--let me back up. Do you know 
enough about this sort of larger system than your, not to imply 
narrow, but narrower authority here? Do you know enough to be 
able to describe or to be able to say definitively that all 
these ingredients come from the United States?
    Ms. Forfa. I would be happy to get back to you on that.
    Chairman Brown. So I mean, I know in response to some of 
the issues with pet treats, with dogs getting sick, with dogs 
dying in some cases, with not yet always proving what happened 
but the fear that some pet owners have, that I know of pet 
owners who now buy things only with an American flag or only 
``Made in the USA.'' But you're not willing to definitely say 
that every ingredient in here in fact comes from the United 
States?
    Ms. Forfa. I will be happy to get back to you. I will be 
happy to look into that and get back to you on that.
    Chairman Brown. Okay. Okay.
    Ms. Forfa. I'm always reluctant to give definitives.
    Chairman Brown. No, I understand that. Last question, if I 
could. I understand that FDA works with the Centers for Disease 
Control and Prevention [CDC] on the pet treats issue. Talk to 
me about the coordination and information sharing. Are you 
satisfied with that?
    Ms. Forfa. Certainly. I'd be happy to, actually. This is a 
rather unique situation because normally we don't have a CDC-
type infrastructure for pet-related illnesses. We did reach out 
to our colleagues at CDC and ask them for help in doing a case 
control study and helping us with some of our epidemiologic 
work.
    They are currently working on a case-control study for us 
where they are calling pet owners whose dogs had reported cases 
of illnesses and comparing those to those controls, controls 
they picked in similar geographic areas where no pet illnesses 
were reported.
    This was done just recently and we don't have the results 
back yet, but we are very grateful to our colleagues at CDC for 
their willingness to--they came up and met with us--and for 
undertaking this case-control study with us.
    Chairman Brown. Okay. Last question. I am, in a couple of 
minutes, going to turn it over to Congressman Smith.
    There's a common perception that pet food treats are not 
fairly regulated here, and less so in China. I think from 
Congressman Smith's opening statement about Upton Sinclair and 
``The Jungle,'' I think that people in this country, except 
those who think government has no role in anything, are pretty 
satisfied that we do a pretty good job in this country with our 
food supply, with our pharmaceutical supply, and with water and 
generally issues around what we eat and what we breathe, and 
what we drink.
    How much is--if in fact this is--did come entirely from the 
United States, if all the ingredients in Happy Hips came from 
the United States, should people be confident that we inspect 
well enough our own facilities and make sure that these 
products are in fact safe for pets?
    Ms. Forfa. We consider pet food--while it has some 
differences, we consider it very similar to food. It needs to 
have ingredients, it needs to be properly labeled, so we work 
very hard to ensure that the American pet food supply is safe.
    Chairman Brown. But you still couldn't answer the question, 
that this pet food, if this is entirely from the United States, 
that every ingredient is in fact from the United States. You 
can't assure us of that until you get back to us, though?
    Ms. Forfa. Correct.
    Chairman Brown. Okay. All right. Thank you.
    Ms. Forfa. Thank you.
    Chairman Brown. Mr. Smith?
    Representative Smith [presiding]. Thank you very much, Mr. 
Chairman.
    Just briefly--I do have a lot of questions but I'll submit 
some more for the record--just on the visa delay, how many 
visas have been delayed or denied?
    Ms. Forfa. That, I will have to get back to you on.
    [The information appears in the appendix.]
    Representative Smith. Because again, I would share the 
concern with my good friend and colleague Chairman Brown. Not 
only is that a low bar, it should be a red flag. I mean, what 
are they hiding? Why are they unwilling? I mean, I can't get a 
visa to go there, at least not recently, because of human 
rights work. But for people to be coming in to do your vital 
mission to protect American end consumers as well as those who 
have pets, that raises a lot of questions.
    Let me ask you, Doctor, if I could. Shaun Kennedy is the 
director of the Food System Institute at the University of 
Minnesota. In his testimony he talks about, if the problem is 
low-level contamination and cumulative doses are the reasons 
for the illness, it could unfortunately take much more time to 
figure out. Whether for human or for animal food, there are 
more of those for chronic toxicity than with acute toxicity.
    This becomes even more important for both infants and pets, 
who tend to have the same limited sets of foods over time so 
that a low level of contamination in the treats, sometimes not 
considered an acute health risk, could lead to chronic illness 
with a steady dose of treats over time.
    How do you screen that out, long-term cumulative dosing of 
toxic substances that get into either an infant or a person's 
system, or a pet? Who's looking for that?
    Ms. Forfa. Many of the illnesses that we've seen are acute.
    Representative Smith. Right.
    Ms. Forfa. And so we have an incredible team working on 
this. We have epidemiologists, toxicologists, veterinary 
researchers, including the woman who was able to crack the 
melamine code in 2007. So we have put all of our experts on 
this and we've screened for a number of things that would cause 
the types of illnesses we've seen, including salmonella, 
metals, markers of irradiation, pesticides, antibiotics, anti-
virals, molds, rodenticides, nephrotoxins, because the 
illnesses of most concern to us are the kidney issues.
    So we're particularly focused on nephrotoxins and any other 
chemical or poisonous compounds that we can think of that would 
cause these types of illness patterns that we've seen. We have 
also reached out through a wide network that we've developed to 
private universities and laboratories and our state 
counterparts to make sure that we have all of the laboratory 
expertise that we possibly can to screen for everything that 
they can think of. So I'm confident that while we haven't found 
a definitive cause, we are covering the waterfront to the best 
of our ability.
    Representative Smith. And can you assure us that there's a 
robust surveillance on long-term toxicity?
    Ms. Forfa. While on the animal side we don't have the same 
sort of surveillance system that we do on the human side 
through the Centers for Disease Control and state public health 
partners, since melamine we have instituted a number of 
reporting portals, including a pet food reporting portal and a 
number of other reporting tools for veterinarians to be able to 
get the information to us so that we can do our own 
surveillance work.
    Representative Smith. Now, is China shipping processed 
chicken to other nations?
    Mr. Engeljohn. Yes.
    Representative Smith. Are they concerned about the 
inadequate slaughter and the process that's involved?
    Mr. Engeljohn. I'm not aware of the requirements other 
countries have with regard to their equivalency type process 
for countries.
    Representative Smith. Okay. If I were shipping to any 
countries like in Europe where they might have a heightened 
concern about food safety?
    Mr. Engeljohn. I don't have specifics on that, but we 
certainly can follow up and let you know what we can find out.
    Representative Smith. Okay.
    Representative Smith. Just one thought. I chaired a hearing 
on Nigeria not so long ago on counterfeit products, 
pharmaceuticals and the like. Many of our witnesses came in and 
held up one that was made as a counterfeit to an American 
product that said ``Made in America'' but was made in China, 
and one product after another--I don't know if it applied to 
chicken, processed chicken, but again the idea that a country 
that so mistreats its own people with its human rights abuse, 
and lacks transparency to the nth degree--can it be counted on 
to come clean on ensuring that products are what they say they 
are and have been processed the way they ought to have been 
processed? It's a very threshold question but one that I 
struggle with.
    I am out of my questions, but I think we need to move on. 
So I guess I'll just thank you both. Look forward to hearing 
back from you on some of the questions that you need some 
further elaboration on, but thank you again for your work. 
Appreciate it.
    Ms. Forfa. Thank you.
    Representative Smith. I'd like to now welcome to the 
witness table our second panel.
    [Pause.]
    Representative Smith. I'd like to introduce our very 
distinguished panel, panel two, beginning with Shaun Kennedy, 
who is Director of the Food System Institute and an adjunct 
associate professor in the Department of Veterinary Population 
Medicine at the University of Minnesota's College of Veterinary 
Medicine.
    Previously, Professor Kennedy was an associate professor 
with Food Systems at the University of Minnesota, where he also 
served as director of the National Center for Food Production 
and Defense.
    Then we'll hear from Patty Lovera, who is the assistant 
director of Food & Water Watch and runs the organization's food 
policy team. Before joining Food & Water Watch, Ms. Lovera was 
the deputy director of the energy and environment program at 
Public Citizen, and a researcher at the Center for Health, 
Environment and Justice.
    Then we'll hear from Christopher D'Urso, who is a consumer 
advocate and graduating senior at the Law & Public Service 
Learning Center at Colts Neck High School in Colts Neck, and as 
I indicated earlier he has actually provided extraordinarily 
useful information to my staff and me. He really is an advocate 
for revamping country of origin labeling laws, and he's been 
doing that since 2012.
    So Professor Kennedy, if you could begin.

 STATEMENT OF SHAUN KENNEDY, DIRECTOR, FOOD SYSTEM INSTITUTE, 
  LLC; ADJUNCT ASSOCIATE PROFESSOR, DEPARTMENT OF VETERINARY 
POPULATION MEDICINE, COLLEGE OF VETERINARY MEDICINE, UNIVERSITY 
                          OF MINNESOTA

    Mr. Kennedy. Thank you, Cochairman Smith, for the 
introduction. And thank you, Chairman Brown and the members of 
the Commission, for the opportunity to speak to you today about 
the current concerns of the safety of the food and feed system 
and how we might be able to make it safer.
    As a proud owner of Storm, an Aussiedoodle, the pet treat 
problem is personally troubling. That the treats are chicken 
jerky raises concerns over USDA's designation of China as an 
equal-to country for processed poultry.
    The potential of the ongoing PEDv outbreak in swine may be 
attributable to feed is another example of uncertain food risk. 
Among many possible solutions to these food system concerns are 
demands for increased inspection and country-of-origin labeling 
[COOL]. Before addressing either I'd like to provide a bit of 
context around our food and agriculture system.
    It is often hard to conceptualize how global our food 
system really is. In the first four months of this year, we 
imported food from more than 179 new countries, totaling $48 
billion and 26 million tons. Focusing on consumer-oriented 
foods, we imported $23.5 billion and 11 million tons. That's 75 
pounds per person, or over half a pound a day. We are always 
eating food that comes from around the world, from over 88,000 
domestic and 116,000 foreign facilities.
    Figuring out the origin of each ingredient in a meal is a 
significant challenge, but where it could come from is easier. 
If your lunch is a cheeseburger, French fries, and milk, the 
last two are fairly easy. We're a big producer of milk and 
French fries, importing either from only a few countries, 
mostly Canada, although the vitamins in milk are mostly 
imported. The cheeseburger is more of a challenge, as it 
components last year contained 75 or more individual 
ingredients that are imported from over 55 countries, providing 
billions of possible combinations of country of origin.
    Sources may change several times a year. Ingredients also 
may be commingled in entirely different ways at different 
times. Clearly, accurate and informative COOL is thus a 
challenge.
    The only reasonable option might be to provide the 
information on something like a QR [quick response] code for 
access to details that cannot be reasonably provided on the 
label. Whatever the solution, there is an additional expense. 
The scale and complexity also contributes to the challenge of 
ensuring our food is safe and how we can figure out when things 
go wrong.
    As you heard with the pet treats, no causative agent has 
been identified. Without knowing what is causing the illness, 
and thus no means of screening products, firms and authorities 
have limited options. Purina has moved to a dedicated, direct 
supply chain in China for its pet treat production to better 
ensure their safety, but until the cause of illness is known, 
even that may not be enough.
    When the cause of illness is known, inspection and testing 
have limited utility in protecting public health. Inspections 
have many benefits, including ensuring that the food safety 
system design meets all the requirements. They do not, however, 
provide assurance of no food-borne illness risk. That would 
require 100 percent inspection of every step and that is simply 
not achievable.
    Under the Food Safety Modernization Act [FSMA], facilities 
have to be inspected every three to five years and it is 
already well beyond the resources currently available to FDA. 
Even annual inspections would not ensure the safety of any 
specific food.
    Similarly, for product testing to provide 100 percent 
assurance of safety would require testing all servings of the 
product, leaving very little to actually eat. Product testing 
is still an important part of an effective food safety plan and 
it provides monitoring of the food safety system. You first 
have to know what to test for and how you're going to test and, 
for pet treats, we don't yet know.
    With this ongoing concern, granting ``equal to'' status for 
processed poultry from China may seem odd, but that does not 
mean the consumer is going to be exposed to dramatically new 
food-borne illness threats from processed poultry in China. 
Since 2010, there have been five multi-state food-borne illness 
outbreaks associated with U.S. poultry, so there is already 
some level of food-borne illness risk.
    One of the absolute best poultry plants I have ever 
conducted an audit on was actually in China. That facility's 
food safety system was driven primarily by its company 
standards and customer expectations, and that is very common. 
So while there is some baseline risk of illness due to 
consumption of food from any country, the real answer lies in 
the specific food systems, the visibility firms have of them, 
and how they are managed.
    While not yet confirmed, feed has been strongly implicated 
in PEDv. Testing, however, has not confirmed feed is a source 
of any outbreak or that there is broad contamination of feed. 
With PEDv it's not just the animal that eats the feed that gets 
sick, but also those it infects, so given PEDv's low infected 
dose, low sporadic contamination of the feed or its packaging 
could spread the virus broadly. So even a robust testing 
strategy capable of detecting low levels of virus in every 
batch could not match the effective sampling strategy of 
feeding tens of thousands of pigs where only a few of the 
servings would have to be contaminated.
    To summarize, until the cause of the pet illness is 
understood, import inspections and recalls provide no assurance 
of safety. Even when the source is understood, it will still be 
more effective for firms to manage their supply chains to 
mitigate continued exposure.
    As is the case for domestic sourcing with appropriate due 
diligence, importers will have the ability to maintain the 
safety of the proposed processing of poultry products from 
China. If the feed system is proven to be the means by which 
PEDv is spread, sampling and testing of feed and feed 
ingredients will be a necessary but insufficient means of 
protecting the swine industry.
    COOL is not as simple as it sounds, but technology-based 
solutions make it more realistic. In each case, supply chain 
visibility is a key part. While the overall food and 
agriculture system does a remarkable job of safely feeding us, 
we should do better. For effective partnerships across 
stakeholders, the encouraging thing is, we can.
    I thank you for your time.
    Representative Smith. Professor Kennedy, thank you very 
much for your testimony and for your longer statement, which 
went into even greater detail. I appreciate it.
    Without objections, all of your longer statements will be 
made a part of the record, but please feel free to use as much 
of it as you would like.
    [The prepared statement of Professor Kennedy appears in the 
appendix.]
    Representative Smith. Ms. Lovera?

  STATEMENT OF PATTY LOVERA, ASSISTANT DIRECTOR, FOOD & WATER 
                             WATCH

    Ms. Lovera. Good afternoon. My name is Patty Lovera and I 
am the assistant director of Food & Water Watch, a nonprofit 
consumer advocacy organization. Thank you so much for the 
opportunity to present testimony on this important topic.
    The United States is increasingly reliant on imported food 
and China is a growing supplier of the food imports that are 
entering the U.S. China is the world's leading producer of many 
foods that Americans eat and it's also a leading producer of 
many of the inputs used to make processed food, and I discuss 
that in a lot more detail in my longer written testimony.
    But the poorly controlled expansion of China's economy is 
often fueled by excess pollution, treacherous working 
conditions, and dangerous foods and products that pose 
significant risk to consumers in China and worldwide.
    U.S. oversight of China's food processors has not remotely 
kept pace with the growth in these imports. Just as one 
example, the inspection rate that the Food and Drug 
Administration can maintain for imported food products means 
that less than 2 percent receive inspection.
    The list of products imported from China may soon grow, as 
the USDA is considering allowing processed poultry products to 
enter the United States from China. This is a process that has 
been going on for several years. We've had rounds of audits, as 
you just heard, many of which revealed significant problems in 
the food safety system in these plants. There's been a World 
Trade Organization complaint that's gone several rounds on 
this, and we've even seen congressional intervention to block 
these imports, we think for good reason.
    As we heard earlier in the earlier panel, the USDA has said 
that the inspection system of the Chinese Government for 
processed products is equivalent to ours, and so once the 
Chinese Government certifies those plants that they say are 
eligible, we could see these shipments begin.
    The chickens were supposed to come from approved sources, 
which would not be China, but places like the United States or 
Canada. But we are extremely concerned that without having USDA 
inspectors in these Chinese processing plants, it would be 
virtually impossible to verify that these products are made 
from birds from these approved sources.
    You heard a little bit in the first panel as well about 
relying on re-entry inspection and what happens at the border. 
While poultry products are not yet coming in from China, we are 
getting a lot of examples of the attacks that happen on that 
re-inspection system, whether it's products from Canada or 
other countries, and relying on that as a backstop makes us 
very, very nervous, as opposed to dealing with the real 
questions of whether the inspection system in the origin 
country is strong enough to start with.
    There are also concerns about the potential for processed 
poultry products from China to end up in school cafeterias. 
There are a few inter-related policies happening. While the 
National School Lunch program run by the USDA is supposed to 
source domestic product, much of the food that schools buy 
doesn't come through that program. They can go to the open 
market, to private vendors.
    They are supposed to look for U.S.-origin products to the 
maximum extent possible, but if the products don't have a label 
or schools have cost pressures that make them choose something 
else, we're afraid that that's a route for this Chinese origin 
product to end up in school cafeterias.
    There's also a definition problem about what a U.S. product 
is in the school lunch venue. If over 51 percent of the content 
in a very processed product, like a burrito, is from the United 
States, the other 49 percent doesn't have to be. So that's 
another avenue that we're worried about.
    To move on to the pet food issue, we think this is becoming 
a classic example of the transparency issues that we have heard 
about. In August 2012, the FDA published inspection reports 
that revealed that Chinese pet treat factories refused to allow 
U.S. inspectors to collect samples for independent analysis, 
and shortly after that we heard about the New York State 
Department of Agriculture and Markets doing their own testing 
and finding violative antibiotics that were not supposed to be 
used in poultry.
    So we have a lot more that we need to do on the safety 
front, but I do want to spend my last minute talking about what 
consumers see in the marketplace because I'm a consumer 
advocate.
    Representative Smith. Don't hurry.
    Ms. Lovera. Okay. We have a lot to do on safety. I put a 
lot of recommendations in my longer testimony about that. But 
at a minimum, in the day-to-day while we're dealing with these 
safety problems, consumers need accurate information so they 
can make good decisions for themselves, and they're not getting 
it. If we're talking about either pet treats or processed 
poultry products, there's a lot of loopholes combining to make 
it very hard for consumers to navigate this.
    So, despite a very long battle that we're still waging in 
the courts and at the World Trade Organization, we do have 
country of origin labeling for agricultural commodities like 
meats and poultry and fruits and vegetables, but that breaks 
down when we start to get into these processed foods because 
they're exempt from labeling requirements.
    The way that USDA has defined that exemption leaves a lot 
of foods uncovered, and we're very concerned that a lot of 
these processed poultry products could be uncovered. When we 
move on to pet treats, there is even less labeling for 
consumers to access.
    So we've heard a little bit about the varying ways it 
combines, but just because the definition of where a product's 
origin is depends on where it was substantially transformed, 
this could mean a low-value commodity being transformed into a 
more valuable processed product. That can determine the origin, 
which could be confusing for consumers if that commodity 
they're concerned about is chicken that comes from a place like 
China.
    So we have a long list of recommendations in my longer 
testimony, but I will pull out just a couple. We think that 
it's time to start over evaluating this process of whether 
China is equivalent to USDA in inspection. There's a lot more 
that FDA needs to be doing to deal with increasing food imports 
from China, and we're very concerned about one mandate that is 
happening, that they rely on third party certifications as 
opposed to FDA inspection.
    Then there is a lot that needs to be done for consumers to 
get better information. We need to fix these loopholes in 
country of origin labeling under the Farm Bill about what 
``processed'' means, and then we also need to bring in these 
other agencies, Customs and also the Federal Trade Commission, 
to figure out what coverage we have for these other processed 
foods.
    One example that we could look at is imported juice. There 
are special rules for juice because we're bringing in 
concentrate, blending it together here, and consumers do get 
more information about that because a policy was written to 
give people that origin information. So, we think that that is 
an avenue to explore.
    So, thank you.
    [The prepared statement of Ms. Lovera appears in the 
appendix.]
    Representative Smith. Thank you very much for your 
testimony and for your extensive recommendations at the end of 
it. I just read through it. It's excellent.
    Mr. D'Urso?

 STATEMENT OF CHRISTOPHER J. D'URSO, GRADUATING SENIOR, LAW & 
 PUBLIC SERVICE LEARNING CENTER, COLTS NECK HIGH SCHOOL, COLTS 
                            NECK, NJ

    Mr. D'Urso. Chairman Brown, Cochairman Smith, and 
distinguished members of the Commission, I am extremely 
grateful and honored to participate in this hearing.
    My efforts to promote revamping country of origin labeling 
[COOL] laws resulted from an unfortunate experience before 
Christmas 2011. After eating my family's pignoli cookies, I 
suffered from pine mouth, a bitter metallic taste that lasted 
for several days. I soon discovered this was caused by a 
cheaper, inedible species of pine nuts which are commonly 
substituted by unscrupulous Chinese companies. Upon examining 
the bag of pine nuts, I was shocked to learn it did not have 
COOL, and consequently investigated why this was the case.
    Under the Tariff Act of 1930 and the Farm Bills of 2002 and 
2008, food products, dietary supplements, and pharmaceuticals 
do not need to have COOL if they are made in the United States 
or imported and processed in the United States. Unfortunately, 
these laws do not explicitly define processing, which has been 
too broadly interpreted to potentially include roasting peanuts 
and mixing peas with carrots. Equally disturbing, chicken that 
is slaughtered in the United States can be exported to China 
for processing and subsequently re-exported to the United 
States as a nugget or soup, potentially without COOL. The 
Congressional Research Service estimates that only 11 percent 
of pork, 30 percent of beef, 39 percent of chicken, and 40 
percent of fruits and vegetables may be required to have COOL. 
The remainders are either produced in the United States or 
imported and processed in the United States. However, consumers 
will not know the reason. Regardless of the circumstances, all 
foods, dietary supplements, and pharmaceuticals should have 
COOL in order to protect consumer rights, public health, and 
American businesses.
    Primarily, consumers have the fundamental right to know 
information about products in order to make informed purchasing 
decisions. Increasing imports from countries such as China may 
pose significant safety concerns. Alarmingly, the FDA admits it 
``does not--nor will it--have the resources to adequately keep 
pace with the pressures of globalization.'' It inspects less 
than 1 percent of food shipments to the United States, and it 
admits that it would take nine years to inspect every high-
priority, foreign pharmaceutical facility just once. Thus, 
consumers are left vulnerable and are forced to protect 
themselves. This can be achieved through the use of COOL where 
consumers can avoid products from countries with known safety 
issues.
    Furthermore, consumers will pay more for products labeled 
``Made in the USA.'' In a study by Colorado State University, 
73 percent of consumers were willing to pay a 19 percent 
premium for USA-guaranteed steak, and a 24 percent premium for 
USA-guaranteed ground beef. Based on these findings, the 
University of Florida estimated that implementing COOL would 
increase annual profits by $900 million for the U.S. steak 
industry, and $3 billion for the U.S. ground beef industry.
    Unfortunately, this issue increasingly affects my 
generation as the world becomes globalized, moving toward one 
market where supply chains are exceedingly complex. 
Additionally, we thrive on having immediate access to 
information so that we can express our preferences, such as not 
purchasing products from countries with safety concerns, 
environmental issues, or human rights violations. Consequently, 
processing must be clearly defined by law and all products, 
both foreign and domestic, must have COOL.
    Thank you for your time.
    [The prepared statement of Mr. D'Urso appears in the 
appendix.]
    Representative Smith. Thank you very much for your 
recommendations and insights as well, and again for, a couple 
of years ago, providing me with some insights that I had not 
been privy to, particularly about the origin of labeling.
    Let me ask Ms. Lovera the first question, if I could. You 
talk about how the Bush administration pushed, as you put it, 
``public blessing of chicken.'' Thankfully, Congress didn't go 
along with that. Then you talk about how President Obama met 
with Hu Jintao, and shortly after this USDA announced new steps 
to be taken to honor China's request to export chicken to the 
United States.
    It was at that very meeting with Hu Jintao that I 
personally raised a number of concerns about Liu Xiaobo, the 
Nobel peace prize winner, which may seem like a disconnect at a 
hearing like this but it absolutely is connected because that's 
when Hu Jintao pretty much, and the President as well, just 
overlooked the whole human rights issue for the art of the 
deal, for more money and more trading, which if this was a 
democracy we'd all be breaking out the champagne bottle, but 
it's not.
    So I'm wondering what came out of that. Is that what 
unleashed the current situation that we find ourselves in with 
the push to issue new regulations? It seems like that is pretty 
much in the very near future. What do all of you think about 
the denial of visas for our people to go there and do their due 
diligence to try to protect American consumers? I think that's 
in the theater of the absurd category, when someone going over 
there as part of a trade mission, and this is obviously a 
safety inspection mission, is precluded their ability to even 
be physically present.
    Professor Kennedy, maybe you want to speak out a little bit 
further about this low-level contaminant issue, that you 
highlighted in your testimony? I think that's a really 
important issue that does not get the focus. I thank you for 
bringing that out in your testimony.
    Ms. Lovera, you pointed out too about the infant formula, 
which I raised--we all have raised--for years. Three hundred 
thousand infants were sickened by melamine, 12,000 were 
hospitalized, and at least 6 children were dead. But very often 
with chemicals it's not just the acute, it's the longer term.
    I wonder if anyone has tried to follow up on what happened 
to those 300,000 estimated children who were sickened, and 
especially those who were hospitalized. I mean, it seems to me 
that, again, underscoring the dangers here, it's not just 
short-term you get sick, you get salmonella or some other 
sickness. I've had it. I've had E. coli. It hurts you for 10 
days and then you're better after a combination of antibiotics.
    But some of these things obviously go deep into tissue and 
cause recurring, and maybe lifelong--we all know what mercury 
does. As you pointed out, the tilapia coming here--the number 
of pounds is huge. So if you could speak to some of those 
issues, and then I have some additional questions.
    Ms. Lovera. Sure. So for the first question about the 
process and the timeline of events for China's system being 
declared equivalent, we have always been very concerned that 
this was less about the standards in their system being held up 
to the standards in our system than it was about opening this 
market.
    In addition to the human rights issues that you've 
mentioned, which always seem to be a piece in the chess match 
of trade negotiations, we have been very concerned that this is 
happening at the same time that the U.S. beef industry is 
tremendously motivated to get the Chinese market opened to our 
beef, and we don't think that the timing is coincidental.
    So this is what worries us, when trade trumps everything 
else. As we enter this next phase where the United States is 
negotiating new trade agreements, across both oceans with the 
TPP or the TTIP, this is what concerns us. These are trade 
agreements that are about reducing barriers to trade, which is 
fancy language for standards.
    As consumers we need those standards. We need them to be 
set here, somewhere that's accountable to us as citizens. The 
Chinese food inspection system is not accountable to me as a 
U.S. citizen. I can't vote for them, I can't express that I 
think they're doing it wrong. We need to have confidence that 
we're using U.S. standards to judge what is safe to come in 
here and we worry a lot about that.
    This is a perfect example of what happens when that gets 
put aside and it's more about moving product to a better 
market. On the visas issue, it concerns us greatly. We think 
that accessibility and the transparency of that system was an 
issue in figuring out the melamine situation. There was a 
delay. We don't think that we can respond, the United States 
can't respond, to track down problems if there's this kind of 
hold-up.
    So again, it's a transparency issue and an accessibility 
issue about whether we're really going to be able to get there 
to figure out if there is a problem. On adulteration, with 
melamine as an example, this is something that folks who study 
China's food system bring up all the time. The jargon for it is 
economically motivated adulteration. The news media likes to 
call it food fraud.
    I mean, whatever you call it, it's about substitutions that 
are cheaper and health is not being considered when the 
substitutions are being made, but you're vulnerable to that in 
a supply chain that is very long with a lot of middle men.
    It was melamine in the milk powder, but then that got 
cracked down, but then we heard about some other product that 
was using scraps of leather, which has all kinds of metal 
contaminations, for derived protein, and you put that in the 
milk powders to try to beat the protein test. It just seems to 
be a recurring theme, in this market in particular. 
Substitutions that may not be safe do seem to be rampant and 
it's just one more reason we're very concerned about that being 
in the supply chain of food processors.
    Representative Smith. Professor?
    Mr. Kennedy. So first, relative to the point of visa 
denials to FDA, that is concerning that our officials are not 
able to get better access to these facilities. If you go back 
to the melamine contamination of wheat gluten that impacted 
pets here, the FDA was delayed in getting inspectors into China 
to take a look at the facilities involved because of just the 
relationship and the time required.
    Actually, a firm that I'm familiar with was able to get 
their own people into that facility much earlier because they 
had people on the ground in China that were available to do 
that, and that's what the goal of having the offices in China 
is, to have that ready access and the ability to get into those 
facilities. That requires someone to have a visa in order for 
us to get in.
    On the point about the process by which equivalency is 
being granted to China on processed poultry, and eventually 
being granted on poultry slaughter, as the Assistant 
Administrator outlined, this is basically a process that falls 
under our agreements with the WTO. So once we establish a 
specific food safety standard, we have to hold both foreign and 
domestic firms to that same standard.
    So if we are not comfortable with how that standard is 
deployed overseas, we have to find a way to rewrite it so that 
it is applicable to both overseas and domestic firms and our 
comfort level with those organizations.
    One of the challenges for doing the equivalency assessment 
is that it is a combination of a paperwork exercise and a 
limited amount of on-site inspection. So you go through a 
documentation review to make sure that the laws and regulations 
are the same as in their country as they are in our country, 
and that all of the requirements are the same.
    Then you go into a limited set of audits to confirm that 
their practices are actually consistent with that. They are 
never surprise audits. They are always announced audits. So, 
yes, there is always the opportunity for the receiving country 
to decide that they are going to show you their best four 
plants and see if they can get that through. It's going to be 
true in any country but it's obviously a concern in a place 
like China.
    But if we are not comfortable, we have to change how we 
regulate our own selves because it's going to change our status 
under the WTO if we make something more stringent for foreign 
manufacturers than we make it for ourselves.
    If you go to the whole question about chronic toxicity and 
how that comes about, and what are the concerns there, if you 
go back to melamine contamination of pet food, the pet deaths 
were not because they consumed one bowl of the melamine-
contaminated pet food and then got ill. They ate several, 
repeated doses of that material until they built up enough of 
the melamine to have melamine isocyanuric acid crystals 
accumulate in their kidneys and result in necrosis of the 
kidneys.
    So that kind of chronic toxicity can be something that will 
present as an acute illness, but it's actually due to the 
chronic accumulation of that material over time. It is 
particularly troublesome for pets and children, as I mentioned 
in my longer testimony, because they eat the same thing every 
day. So if there's a low level of contamination that we don't 
understand, it can lead to these problems. That could be why 
this is taking so long to figure out because it's not anything 
we've ever looked at.
    If you look at the report from FDA on what they've tested 
in the pet treats, it's probably the most expensive testing of 
contaminants in a food item that they've ever had to do and 
they still haven't figured out what it is because it's not 
something we're used to seeing. That's a continual problem.
    The point was just raised by Ms. Lovera about economically 
motivated adulteration, and that is obviously an ongoing 
concern with China and has been for some time. Let me first 
remind everyone that economically motivated adulteration, or 
food fraud, is not new. It is as old as food.
    The earliest food laws in Germany and in Egypt had to do 
with food fraud. Food fraud of protein products in the United 
States used to be a problem; it used to happen here, too. We 
substituted urea for protein in various products. So the 
Chinese are just going through a different series of 
substitutions a decade or two after we did the same thing.
    Food fraud is considered to, by the Grocery Manufacturers 
Association, lead to $10 to $15 billion worth of economic loss 
to the food industry and may have up to 10 percent of food on 
shelf not being exactly as labeled. So consumers have the 
challenge of knowing what something is even when people are 
trying to do the right thing, but it's even more challenging 
when someone is not trying to do the right thing.
    Then lastly on the whole question of the follow-up on China 
and the infant formula and what happened to those children over 
time, I'm not familiar with any studies that look at the long-
term health effects of those original 300,000 children that 
were sickened in that event so I don't know if anything has 
been done there.
    The only long-term exposure study that I'm aware of that 
has been done due to a food-borne illness contamination is 
actually related to an economically motivated adulteration of 
olive oil in Spain, which led to 700 deaths and thousands of 
chronic illnesses over time. That happened over 20 years ago 
and they're still monitoring the long-term health of those 
patients in that area of Spain, but that is only one of a 
large-scale contamination event that had chronic issues that 
I'm familiar with.
    Representative Smith. Mr. D'Urso, if I could ask you, as 
you testified, imported products that are processed in the 
United States are exempt from COOL. Who determines what 
constitutes processing, and can you explain how Customs and 
Border Protection and Agricultural Marketing Services define 
processing?
    Mr. D'Urso. Sure. Unfortunately, the processing exemption 
is not something that is explicitly explained in the COOL laws, 
so it would be determined by the regulations of the enforcing 
agencies. Customs and Border Protection enforces the Tariff Act 
of 1930 aspect, which covers most imports. The Agricultural 
Marketing Service of the USDA enforces the Farm Bills of 2002 
and 2008, which cover the agricultural commodities. 
Unfortunately, the two agencies have sometimes contradictory 
interpretations of the processing exemption, which leads to 
confusion and misinterpretation.
    Customs and Border Protection defines processing as any 
method which results in the substantial transformation of a 
product whereby it experiences a change in name, character or 
use, where Agricultural Marketing Service defines processing as 
any type of cooking, curing, mixing, smoking, or restructuring, 
as in emulsifying.
    Representative Smith. So there are contradictions?
    Mr. D'Urso. Yes, there are contradictions between the two.
    Representative Smith. In addition to the processing 
exemption, are there any areas of concern regarding COOL? As 
you testify before the Commission, do you have any suggestions 
or recommendations as to how to strengthen the COOL laws?
    Mr. D'Urso. Absolutely. There are two other major issues 
where COOL laws need to be strengthened. First, companies 
oftentimes use catch-all labels whereby a multitude of possible 
countries of origin are listed, and this should not be allowed. 
Similar to lot numbers and expiration dates where they are 
specifically printed for a given production batch, the same 
should be required of country of origin so that there is no 
doubt as to the actual country of origin.
    Second, as my generation becomes increasingly active with 
online shopping, online retailers in the United States should 
be required to disclose country of origin on the product 
listing Web page to inform consumers prior to purchase. 
Otherwise, consumers won't know country of origin until they 
receive the physical product.
    And as for my recommendations with the specific COOL laws, 
first, the definition--the same definition--of processing 
should be explicitly stated in the respective COOL laws for 
both Customs and Border Protection and Agricultural Marketing 
Service so that it's not open to interpretation and there are 
no conflicts or contradictions.
    In cases where production takes place in multiple 
countries, a product could be labeled as assembled in country X 
of components from country Y, or packaged in country X of 
components from country Y.
    Second, products made in the United States should be 
required to have COOL in order to prevent confusion as to 
whether a product was made in the United States or imported and 
processed in the United States. Such labeling will provide 
consumers with confidence and transparency in the products 
they're purchasing so that they can make educated decisions.
    Representative Smith. Thank you.
    Dr. Engeljohn mentioned that we rely on the government of 
China for so much of the information that we get, audits and 
the like, although we do our own, and that there's a 60-day 
lead time which is, as you Professor, just referenced in terms 
of advanced notice.
    I mean, you can even reconstruct the whole thing if you 
wanted to in the 60-day lead time, it seems to me. And 
whistleblowers, which I asked about. I wonder if you have any 
thoughts, any of you, on the need to protect whistleblowers if 
they do exist in China with regard to this.
    Ms. Lovera, you made a very important point about the 
school lunch program, to the maximum extent possible and the 
flexibility that local schools will have to buy things that 
have been made in China, chicken for example, that may be 
injurious to their students' health. How do we fix that?
    Ms. Lovera. Well, one thing that is extremely current is a 
provision in the House version of the agricultural 
appropriations for 2015 that would block importation of 
processed poultry for the school lunch program. It needs to be 
in the Senate version as well. It was, I think, the one thing 
they agreed on during that markup. But it's in the House 
version, so that's one particular piece of attention that's 
being paid to that school lunch issue.
    We're asking school food service directors who are dealing 
with a thousand other things to deal with this. It's a hot 
topic around here right now about how much flexibility they get 
to meet nutrition requirements. They have a lot to do and now 
we're going to have to ask them, if we start importing this 
product, to be on the look-out for this on a vendor list or 
something like that and getting the product in and off the back 
of the truck, and then it has a Chinese label on it, isn't 
going to be super helpful. They need it up front. It's just 
another thing they have to deal with.
    We don't think parents want this. There's a large petition, 
over 300,000 people, a bunch of groups have gathered this 
petition to say that people don't want this in school lunches. 
So I think it's a very fixable problem. That's a smaller scale. 
We would prefer USDA reevaluate the whole decision about 
bringing this product in, but at a minimum it doesn't belong in 
school lunches.
    Representative Smith. Thank you.
    Mr. Kennedy. So relative to the question of whistleblowers, 
I am similarly unaware of any particular whistleblower coming 
forward and reporting a problem in the food industry and there 
being any punishment or reward for that individual. There were 
bloggers related to the melamine incident. I do not know what 
happened to those bloggers in the melamine incident.
    There have been a lot of people in China protesting the 
subsequent failures of the Chinese industry and Chinese 
Government to protect them from fraudulent business practices 
and food safety events, and there have been no public 
prosecutions of any of those people who have protested that I'm 
aware of, but I couldn't speak to that specifically.
    Regarding the school lunch program, while many consumers 
obviously are concerned about the possibility of poultry from 
China ending up in the school lunch program, I think consumers 
would be surprised to realize that it's nearly impossible for 
us to have a school lunch program without some imported 
ingredients being used in that school lunch, and that there is 
a very high likelihood that some of those ingredients are from 
China already.
    Given how we source some of our products globally, it's 
nearly impossible to eat a domestically-only sourced meal 
because there are some things that we simply don't produce. 
Even when we import it from countries we may think are more 
consistent with our own regulatory system, because of the way 
things are labeled by economic value, as Ms. Lovera has 
referred to, it is not always transparent as to where it really 
came from.
    If you do a check on FATUS to see where we get citric acid 
from in the United States, we get it from China and we get it 
from Canada, 50 percent from China, 40 percent from Canada. 
Canada does not make citric acid, so we're getting Chinese 
citric acid through Canada.
    So if we want country of origin labeling it actually has to 
be something that is the provenance of the supply chain owners 
because they're the only ones that have the visibility of the 
supply chain back far enough to say where they actually got 
something. When they do that, sometimes they can't definitively 
tell you what one batch was. If you buy something like 
chocolate, chocolate is intentionally commingled with cocoa 
beans from different sources to get a particular flavor 
profile.
    They'll change that ratio based on the quality of the 
beans, so one day's production might have all four countries, 
one day's production might only have three countries. So it 
becomes complicated for companies to implement country of 
origin labeling unless they do a catchment of sources, we know 
it came from one of these four countries. But as Christopher 
D'Urso has said, some consumers will be frustrated by that.
    The solution I put forth in my written testimony was that 
we have to look at something other than labeling on the package 
because you can't get that level of complexity on the label 
that firms would be able to deploy. We need to look at 
technology solutions so that we can provide Internet access to 
the information they need to know about the product. In using a 
lot-code basis to link to that data you could do that.
    Representative Smith. Thank you.
    Thank you. I yield back.
    Chairman Brown [presiding]. Thank you, Mr. Smith. I 
appreciate that. I apologize again for having to have stepped 
out for half an hour.
    So first of all, I wanted to thank Dr. Engeljohn who is 
still in the room. It is unfortunately all too unusual for 
administration representatives to stay and listen to a 
citizen's panel and we noticed, obviously. Or you look a lot 
like him, the guy that was sitting up here earlier. So thank 
you for that. Congressman Smith knows, too. It doesn't really 
matter, the political party, the administration doesn't do that 
enough. So, thank you for staying and listening to them.
    I have in the last few minutes a question for two of you, 
starting with Mr. Kennedy. You mentioned, and I just heard you 
say kind of again in addition to your written testimony, that 
the hurdle of country of origin labeling is the scale and 
complexity of our entire food system with a single product, 
potentially including ingredients from many different 
countries. Your citric acid story was pretty interesting.
    Given consumers' desire for this information, how do you 
propose a feasible way of providing sort of better, more 
complete, more reliable, and more honest information to 
consumers? How do we build that better?
    Mr. Kennedy. So again, I think it goes back to looking to a 
technology-based solution to enable the firms to provide that 
information in a reasonably accessible form that they can 
reasonably maintain. If you are going to ask them to put it on 
the label, the label would have to be printed uniquely for 
every batch. That becomes cost prohibitive.
    They have to have some standards for labeling the rest of 
the material and labor, but more importantly if it is something 
that has 30, 40 ingredients, which many processed foods have, 
and those ingredients come from any one of 30 countries, where 
is the room on the label to actually list all of that in a way 
consumers could read it and utilize it?
    Whereas if the production code was linked to a database 
that they could access online and say, this is where it's from. 
You do this with those QR codes now when you want to see what 
the reviews are of a product or other information.
    So there are technology options that could make COOL more 
reasonably achievable and give consumers the level of 
information they want. At least the firms that I've talked 
with, their objection is not to wanting to make that 
information accessible to the public, it's that they don't 
always know how to do it if they have to put it on the label. 
It's simply a very significant logistic problem and the level 
of granularity will actually change how they have to process 
the foods in their system in order to comply. So it can be 
done.
    For some foods it becomes very difficult, but because of 
that I think we have to look to non-traditional solutions such 
as creative use of technology solutions to enable firms to do 
so, and look at their ability to gain visibility in the supply 
chain to deal with these problems, and many others.
    Chairman Brown. Ms. Lovera, I don't think you entirely 
agree with that. Give me your thoughts.
    Ms. Lovera. We hear that a lot as a group that's worked on 
country of origin labeling for a long time, and there is a 
spectrum of how complicated foods are. We hear from folks that 
are producing single-ingredient foods that they can't figure 
out country of origin labeling, and that argument we don't buy. 
So we've seen the meat industry attack this concept since it 
came up over a decade ago. So, there are solutions that we can 
figure out.
    If we're talking about the covered commodities that the 
Farm Bill language says that we have to label, ground beef was 
a sticking point for years and there was a compromise that was 
figured out. It doesn't get exactly where Christopher wants us 
to get but it says ``this may contain product from multiple 
countries'' because, whether or not consumers want to hear it, 
there may be lots of different animals in a vat or something 
that becomes ground beef, and it may come from multiple places, 
and that does shift.
    So as a compromise, all sides, including folks who hated 
country of origin labeling and folks who wanted it, came to 
that compromise in the 2002 Farm Bill and said you can do a 
shotgun label as a way to move this process forward.
    I do agree that we eat a lot of processed foods that have a 
long list of ingredients. My consumer advice to people is that 
if it has that many ingredients, maybe you don't need to eat it 
because you can't figure out where they all came from.
    But if people are going to keep eating them and we're going 
to keep making them, we can at least start by giving a little 
bit more information on the package. So one proposal we are 
very interested in is something called ``In-By-For,'' like, 
this was made in this country by this company for this company, 
if it's a subcontracting type of arrangement, which is often 
hidden from consumers. We think that matters because those are 
often still sold under iconic American brands.
    People may not realize that we've shifted that production 
to another country because it's cheaper, because it still says 
candy bar X that you used to buy when you were a kid when they 
made it in whatever State they made it in. So that's a start. 
They may not tell you where every coffee bean or piece of 
chocolate came from, but it could tell you who's doing it. That 
is a start and then we can get into other ideas about the 
various ingredients in a complicated processed food.
    Chairman Brown. Okay. That's very helpful, thank you.
    We're going to wrap up. Before adjourning I want to enter 
into the record a letter of testimony submitted by Terry 
Safranek representing Animal Parents Against Pet Treats Made in 
China. She lives in Brooklyn Heights, Ohio, a suburb of 
Cleveland. Without objection, I'd enter this into the record. 
Thank you, Chairman Smith.
    [The prepared statement of Ms. Sefranic appears in the 
appendix.]
    Chairman Brown. One comment and then I will close. This is 
incredible, just listening to any of the three of you or the 
other two, how complicated this is. If it's complicated to all 
of us who have actually put real time for a number of years 
into studying this, think how complicated it is obviously for 
American consumers. Ultimately when you think of a contaminated 
pharmaceutical and you think of the breadth and the depth and 
the reach of buying these products, and particularly, as 
Cochairman Smith said, in countries that are less than 
democracies or just countries that are so large there is no way 
to really inspect every little mom-and-pop operation making a 
pharmaceutical ingredient or contributing to the food supply. 
So then the cost to U.S. taxpayers when so much of the supply 
is so far flung around the globe, I know the solution to some 
is, with pet food, buy it if it says ``Made in the USA,'' 
although that doesn't always tell the whole story.
    But I think it's also the question of responsibility, that 
those companies that move their production from here to abroad 
and then sell the products back into the United States because 
it saves them money should have ultimate responsibility for the 
products they're sending in, where they came from, where the 
ingredients came from, where they were assembled, where they 
were put together, and what happened as they were shipped back 
to the United States. So I thank the three of you, thank the 
two that testified before. If Chairman Smith or I have any 
written questions, or other members of the Commission do, 
please get responses to us within a week, if you would be 
willing to do that.
    Commission adjourned. Thank you so much.
    [Whereupon, at 5:37 p.m. the hearing was adjourned.]
                            A P P E N D I X

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


                          Prepared Statements

                              ----------                              


               Prepared Statement of Daniel L. Engeljohn

                             june 17, 2014
    Chairman Brown, Co-Chairman Smith, and members of the Commission, I 
am Dr. Dan Engeljohn, Assistant Administrator of USDA's Food Safety and 
Inspection Service's Office of Field Operations. I am pleased to appear 
before you today to explain the current state of U.S. regulatory 
oversight of poultry exported from the People's Republic of China (PRC) 
for human food.
                              our mission
    First, let me take some time to explain FSIS's mandate. By law, 
FSIS is required to examine and inspect all slaughtered and processed 
livestock and poultry, as well as all processed egg products produced 
for use in commerce for human consumption. Our inspectors and 
veterinarians monitor the health of the animals brought to slaughter 
and ensure that livestock are treated humanely. These inspectors also 
collect the samples that our scientists analyze for the presence of 
pathogens and illegal drug residues. These dedicated men and women are 
on the front lines nationwide enforcing regulations and directives 
backed by scientific evidence to ensure that meat, poultry, and 
processed eggs in commerce are safe and wholesome.
    FSIS also regulates all imported meat, poultry, and processed egg 
products intended for use as human food through a three part process:

         First, before FSIS-regulated products can enter the 
        country, the agency determines whether the food safety 
        regulatory system of any country that wishes to export to the 
        United States is equivalent to our own system.
         Second, once FSIS finds a foreign country's food 
        safety system to be equivalent, FSIS re-inspects eligible 
        products from that country at U.S. ports-of-entry. During FY 
        2013, FSIS personnel inspected approximately 3 billion pounds 
        of meat and poultry products presented for import by 28 
        actively exporting foreign countries, as well as about 10 
        million pounds of processed egg products.
         Third and finally, FSIS evaluates an exporting 
        country's food safety system on an ongoing basis. Each year, 
        FSIS reviews any changes in the foreign country's food safety 
        system.

    In addition, FSIS may conduct an in-country audit of the system and 
will review the country's performance in port-of-entry inspections. 
Based on these reviews, the Agency decides whether the country is 
maintaining equivalence, or whether additional Agency action is 
warranted. This performance-based approach allows FSIS to direct its 
resources to foreign food regulatory systems that potentially pose a 
risk to public health and makes our international program more 
consistent with the U.S. domestic inspection system. Our approach 
improves the linkage between port-of-entry re-inspection and on-site 
audits.
                          regulatory oversight
    Again, let me assure you that FSIS follows every mandate given the 
Agency to ensure that our food supply is safe. FSIS audits any foreign 
country that wishes to export meat, poultry, or processed egg products 
to the United States. A foreign country's inspection system must ensure 
that establishments preparing to export to the United States comply 
with requirements equivalent to those in the Federal Meat Inspection 
Act, the Poultry Products Inspection Act, the Egg Products Inspection 
Act, and in FSIS regulations. This is true for the PRC as it would be 
for any other country.
    As you know, pursuant to requirements in the fiscal year 2010 
Agriculture, Rural Development, Food and Drug Administration, and 
Related Agencies Appropriations Act (PL 111-80), the Agency is also 
required to provide Congress with detailed updates on China's request 
for equivalency every six months. However, let me explain briefly where 
we are in the process for the PRC--a process that began in 2004 with 
the PRC's request for on-site FSIS audits of its poultry processing and 
slaughter system.

         First, the United States is not importing any chicken 
        that was slaughtered in China. A March 2013 audit found China's 
        poultry slaughter system not equivalent to that in the United 
        States; and
         Second, FSIS reaffirmed in August 2013 that the PRC's 
        poultry processing inspection system is equivalent to that of 
        the United States. This means that chicken slaughtered in the 
        U.S. or another country whose poultry slaughter system has been 
        found by FSIS to be equivalent to the U.S. system could be sent 
        to China for processing and then exported to the United States.

    Again, the only chicken currently permitted to be imported from 
China is processed chicken from approved sources. FSIS, in coordination 
with USDA's Animal and Plant Health Inspection Service (APHIS), also 
currently requires that all processed chicken products from China be 
cooked.
    China has provided a list of four plants it has certified as 
eligible to export processed chicken to the United States. Before any 
processed chicken can be exported to the United States, a proper export 
health certificate must be developed by the PRC and approved by FSIS 
and APHIS. Such a certificate, a draft of which was submitted earlier 
this month, must demonstrate that the poultry is sourced from the 
United States or from a country with an inspection system for slaughter 
that is equivalent to that of the United States and that the poultry 
was cooked to a proper temperature, among other things. Once FSIS and 
APHIS approve a certificate, and that certificate is agreed to by the 
PRC, the PRC will then be able to determine when to begin shipping 
products from the plants certified to export processed poultry products 
to the United States. The Agency doesn't have any information about how 
much processed product it expects China to ship once certification is 
up and running.
    In addition to carrying a proper certificate, product must be 
properly labeled. Under Poultry Products Inspection Act regulations at 
9 CFR 381.205, immediate containers of poultry products imported into 
the United States for human consumption must bear a label showing the 
name of the country of origin. Because processed product from China 
must be cooked, FSIS believes that it is unlikely that the product 
would be repacked or further processed in this country. If a product is 
not repacked or further processed, the label would indicate that the 
product is from the PRC. If the product were to be repacked or further 
processed in the United States at an official establishment, it would 
not include information that such product was from the PRC, but it 
would be repacked or processed under FSIS inspection. However, I would 
like to emphasize again that our systems-based approach to equivalence 
is designed to assure Americans that the food safety systems of other 
countries that FSIS finds to be equivalent, including the PRC's, are 
effective.
    Of course, FSIS will also conduct annual on-site audits of the 
PRC's inspection system for processed poultry for at least the next 3 
years, as we would do for any country that has just been found to be 
equivalent.
                               conclusion
    The dedicated men and women of FSIS work every day toward a common 
and extremely important goal of preventing food-borne illness. We take 
our mission seriously and understand the importance of our roles in 
ensuring the safety of the nation's food supply--whether from domestic 
or from foreign establishments.
    Thank you for your continued support and the opportunity to report 
on the work we do to protect public health.
                                 ______
                                 

                   Prepared Statement of Tracey Forfa

                             june 17, 2014
                              introduction
    Good afternoon, Chairman Brown, Co-Chairman Smith, and Members of 
the Commission. I am Tracey Forfa, Deputy Director of the Center for 
Veterinary Medicine (CVM) at the Food and Drug Administration (FDA or 
the Agency), which is part of the Department of Health and Human 
Services (HHS). Thank you for the opportunity to be here today to 
discuss FDA's investigation into reported illnesses in pets that 
consumed jerky pet treats.
    FDA has been receiving reports of pet illnesses associated with the 
consumption of jerky pet treats since 2007. As of May 1, 2014, FDA has 
received approximately 4,800 such reports, including 1,800 complaints 
received since FDA's website update in October 2013. The reports 
received involve illnesses in more than 5,600 dogs, 24 cats, three 
humans, and, sadly, more than 1,000 canine deaths. Most of the reported 
cases involve chicken, duck, or sweet potato jerky products imported 
from China. Unfortunately, to date, FDA has not been able to identify a 
specific cause for the reported illnesses or deaths despite an 
intensive scientific investigation. Getting to the bottom of this 
problem is a priority for FDA, and the Agency is continuing its 
comprehensive investigation into the potential cause of the pet 
illnesses.
    The ongoing global investigation is complex and includes a wide 
variety of experts at FDA, including toxicologists, epidemiologists, 
veterinary researchers, forensic chemists, microbiologists, field 
investigators, state research partners, and senior Agency officials. 
FDA has collaborated with our colleagues in academia and industry and 
has reached out to U.S. pet food firms to enlist their help and to 
share data involving this public health investigation. FDA is updating 
veterinarians and pet owners about the investigation regularly via the 
Agency's website and a webpage dedicated specifically to issues related 
to jerky treats. This information has been further disseminated to 
veterinarians by various groups, including the American Veterinary 
Medical Association (AVMA). Most recently, on May 16, 2014, CVM 
released an update entitled ``FDA Provides Latest Information on Jerky 
Pet Treat Investigation.'' CVM also has a webpage entitled ``FDA 
Progress Report on Ongoing Investigation into Jerky Pet Treats.'' In 
addition, the Agency will continue to remind pet owners that jerky pet 
treats are not necessary for pets to have a fully balanced diet, so 
eliminating them will not harm pets since commercially produced pet 
food contains all of the nutrients that pets need.
                         adverse event reports
    The 4,800 reports of pet illnesses received by FDA cover many sizes 
and ages of dogs, and multiple breeds. About 60 percent of the reports 
are for gastrointestinal illness and about 30 percent relate to kidney 
or urinary issues. Some dogs with kidney or urinary issues were 
diagnosed with Fanconi or Fanconi-like Syndrome, a rare kidney disease 
normally seen primarily in certain breeds as a genetic disease, 
although Fanconi can also be acquired following exposure to kidney 
toxins. Affected dogs were reported to involve a wide variety of 
breeds, which makes genetic Fanconi Syndrome unlikely. The background 
incidence of Fanconi Syndrome in dogs is currently unknown, but it 
appears to be increasingly reported in association with jerky treat 
ingestion. The remaining 10 percent of cases involve a variety of other 
symptoms, including convulsions, tremors, hives, and skin irritation.
    In October 2013, FDA published an update on the Agency's website 
which resulted in a surge of 1,800 adverse event reports received by 
FDA. The Agency has determined that about 25 percent of the 1,800 
reported cases were ``historic''; that is, the illnesses occurred 
several months or even years previously. The remaining cases were more 
recent, but may or may not have received veterinary attention. Of the 
new cases since October, the Agency has identified about 125 well-
documented cases for further investigation, and has continued to 
correspond with the owners and veterinarians of these pets to track 
their progress and to obtain test samples of blood, urine, feces, and 
tissue.
    In addition to the October 2013 website update, FDA reached out 
through the AVMA to solicit information about new or ongoing cases 
currently under veterinary care. This is a novel approach, and it 
resulted in the submission of tissue samples (blood, urine, feces, 
necropsy, etc.) from affected dogs that were associated with jerky pet 
treat exposure.
    FDA has also had the opportunity to perform post-mortem 
examinations on dogs suspected of having jerky-pet-treat-associated 
illnesses. As of May 1, 2014, the Agency completed 26 post-mortems on 
the samples submitted since October 2013. In half of the cases, the 
dogs' cause of death was due to a variety of other causes, such as 
widespread cancer, trauma or infections; in the remaining 13 cases, 11 
had kidney disease and two involved gastrointestinal disease. An exact 
causal relationship between these deaths and jerky pet treats has not 
been determined, but involvement of jerky pet treats has not been ruled 
out. We are exceptionally grateful to the owners who consented to allow 
FDA to perform post-mortem examinations of their beloved pets. We 
understand this is a difficult decision to make and sincerely 
appreciate the opportunity to learn more about the potential cause of 
their pets' deaths.
    Beginning in May 2014, FDA has partnered with the Centers for 
Disease Control and Prevention (CDC) to collaborate on a study of cases 
reported to FDA of sick dogs compared with ``controls'' (dogs that have 
not been ill). The goal of the study is to compare the foods eaten by 
the sick dogs (cases) to those eaten by the dogs that did not get sick 
(controls), in order to determine whether sick dogs are eating more 
jerky pet treats than healthy dogs.
    Investigators have identified about 100 cases of kidney illnesses 
in dogs reported to FDA to have occurred on or after July 1, 2013. The 
cases included dogs diagnosed with Fanconi or Fanconi-like illness, or 
dogs that were five years of age or younger and had kidney failure, 
regardless of jerky pet treat exposure. Cases were selected solely on 
this case definition and not on what food they consumed. Data collected 
during this investigation will allow Federal investigators to better 
understand what is making pets sick. The study is still ongoing, and 
FDA will share results when the study is completed.
                        pet food sample testing
    Since 2011, in concert with FDA's Veterinary Laboratory 
Investigation and Response Network (Vet-LIRN), which partners with 
state and university veterinary diagnostic laboratories, the Agency has 
collected approximately 250 jerky treat samples related to more than 
165 consumer-related complaints, plus more than 200 retail samples 
(unopened bags obtained from a store or shipment), and has performed 
more than 1,000 tests on these samples. In addition, the team at Vet-
LIRN ran more than 240 tests on historical samples (those received in 
2007-2011).
    FDA's Vet-LIRN program has included intensive testing for numerous 
contaminants such as: Salmonella; metals or elements such as arsenic; 
pesticides; antibiotics; antivirals; mold and toxins from mold testing; 
rodenticides; nephrotoxins such as ethylene glycol and melamine; and 
other chemicals and poisonous compounds. FDA's test results of jerky 
treat product samples for toxic metals, including tests for heavy 
metals, have been negative.
    Testing has also included measuring the composition of jerky pet 
treats to verify that they contain the ingredients listed on the label 
and do not contain ingredients that are not listed on the label. FDA is 
reaching out to private food testing laboratories for help with this 
work to better allow FDA to focus efforts on other aspects of the 
investigation. It is important to understand the composition of a 
product and its ingredients to determine where there might be a 
potential for problems to occur. For example, during a prior 
investigation involving contaminated pet food, FDA looked carefully at 
all the ingredients and it was later discovered that melamine was being 
used to raise the level of the protein in the products. Currently, FDA 
is investigating whether potentially contaminated glycerin could be a 
possible source of the reported illnesses in pets. FDA has tested a 
limited number of samples of glycerin obtained from inspections and is 
actively investigating new methodologies for analyzing glycerin for a 
variety of contaminants or impurities.
    Testing of jerky pet treats from China has revealed the presence of 
the drug amantadine in some samples containing chicken. These samples 
were from jerky pet treats that were sold a year or more ago. 
Amantadine is an antiviral medication that is FDA-approved for use in 
humans. It has also been used in an extra-label manner (using an 
approved drug in a way that is not listed on the label) in dogs for 
pain control, but FDA prohibited its use in poultry in 2006.
    FDA does not believe that amantadine contributed to the illnesses 
because the known side effects or adverse events associated with 
amantadine do not seem to correlate with the symptoms seen in the 
jerky-pet-treat-related cases. Amantadine, however, should not be 
present at all in jerky pet treats, and the Agency has notified the 
Chinese Administration of Quality Supervision, Inspection and 
Quarantine (AQSIQ) that the presence of amantadine in these products is 
an adulterant. Chinese authorities have assured FDA that they will 
perform additional screening and will follow up with jerky pet treat 
manufacturers. FDA has notified the U.S. companies that market jerky 
pet treats that were found positive for amantadine of this finding and 
is testing both imported and domestic jerky pet treats for amantadine 
and other antivirals. FDA is in the process of conducting a survey 
assignment of both domestic and imported jerky pet treats for 
amantadine, as well as other antivirals. Of the 41 samples analyzed 
thus far, only one has tested positive for antivirals.
    FDA's testing also found various antibiotic residues in chicken 
jerky pet treats, which were also found by the N.Y. State Department of 
Agriculture and Markets. Though FDA does not believe the presence of 
these residues contributed to the reported illnesses in jerky pet 
treats, they should not be present in the products. These findings led 
to the temporary removal from the market of two major brands of jerky 
pet treats.
                         interaction with china
    It was just over a year ago that FDA testified before this 
Commission about FDA's efforts to ensure global product safety and 
quality, particularly in our work related to China. China is the source 
of a large and growing volume of imported foods, drugs, and 
ingredients. Every product imported from abroad must meet the same 
standards as those produced here in the United States.
    Firms always have the primary responsibility to produce safe 
products, but it is important that governments provide meaningful and 
robust regulation to ensure public safety. FDA is continuing its work 
with Chinese officials to help them improve their regulatory system and 
educate them on the new standards that are being implemented in our 
regulatory system.
    FDA has held regular meetings with the Chinese authority, AQSIQ, 
about the jerky pet treat issue. These meetings have helped to ensure 
that AQSIQ is aware of U.S. requirements for pet food safety and to 
share information in support of FDA's investigation.
    In April 2012, FDA conducted inspections of several facilities in 
China that manufacture jerky pet treats for export to the United 
States. FDA selected these firms for inspection because the jerky 
products they manufacture have been associated with some of the highest 
numbers of pet illness reports in the United States. These inspections 
provided valuable information on these firms' jerky pet treat 
manufacturing operations, including the ingredients and raw materials 
used in manufacturing, as well as manufacturing equipment, the heat 
treatment of products, packaging, quality control, sanitation, and 
product testing. Although these inspections helped to identify 
additional areas that FDA may investigate, the Agency found no evidence 
indicating that these firms' jerky pet treats are associated with pet 
illnesses in the United States. FDA, however, did identify concerns 
about the record keeping practices of several of the inspected Chinese 
firms. In particular, one firm falsified receiving documents for 
glycerin, which is a common ingredient in jerky pet treats. As a result 
of the inspection, the Chinese AQSIQ informed FDA that it had seized 
products at that firm and suspended exports of the firm's products to 
the United States.
    As a follow-up to these inspections, FDA sent a delegation to China 
in April 2012 to express our concerns to AQSIQ about the complaints we 
continue to receive concerning jerky pet treat products imported from 
that country. As a result, FDA and AQSIQ agreed to expand the 
investigation of jerky pet treats. In addition to sharing our 
epidemiological findings with AQSIQ, FDA initiated a scientific 
collaboration, and has taken other steps to attempt to identify the 
root cause of the illness complaints. As noted, FDA and AQSIQ are 
meeting regularly to share findings and discuss further investigational 
approaches. FDA has also hosted Chinese scientists at the Agency's 
veterinary research facility to further scientific cooperation.
                       pet food safety in general
    Pet food safety in general continues to be a priority issue for 
FDA. In response to section 1002 of the Food and Drug Administration 
Amendments Act of 2007 (FDAAA), FDA established the Pet Food Early 
Warning Surveillance System. The goal of the surveillance system is to 
quickly identify contaminated pet food and illness outbreaks associated 
with pet food. The system uses data collected by two surveillance 
resources to collect information about pet-food-related problems: FDA's 
Consumer Complaint Reporting System (through the FDA District Consumer 
Complaint Coordinators) and the FDA-National Institutes of Health 
Safety Reporting Portal (SRP) (where consumers can submit complaints 
regarding adverse events in animals associated with the consumption of 
pet food). Information provided through these reporting mechanisms 
helps provide early detection of problems with pet food, enabling FDA 
to respond quickly to prevent or mitigate risks to people and animals.
    The SRP launched in May 2010, allowing the public to submit 
complaints electronically. Using the portal's pet food questionnaire, 
consumers can report possible adverse health effects associated with 
their pets' food. Veterinarians may also report pet food safety 
problems on behalf of their clients and provide valuable medical 
information. Within days of opening the SRP for pet food complaints, 
veterinarians identified a thiamine deficiency in a cat that only ate 
one brand of canned food and reported it through the SRP. FDA notified 
the manufacturer, which promptly initiated a recall.
    Another important safety surveillance tool is a new requirement, 
provided for in section 1005 of FDAAA, that manufacturers, processors, 
packers, and holders of human or animal food report to FDA if there is 
reasonable probability that an article of human or animal food will 
cause serious adverse health consequences or death to animals or 
humans. In conjunction with that requirement, section 1005 also 
required FDA to establish the Reportable Food Registry (RFR), an 
electronic portal to which such reports can be submitted. The intent of 
the registry is to help FDA better protect public health by tracking 
patterns of possible food and feed adulteration and to better target 
inspection resources. By providing early warning signals about 
potential health risks, it has increased the speed with which FDA, its 
state and local partners, and industry can remove hazards from the 
marketplace. For example, in 2011, a pet treat distribution company 
submitted a report to the RFR that their pig ear dog treats were 
contaminated with Salmonella. After FDA's investigation, two lots of 
the affected pet treats that had been distributed to 18 states were 
recalled.
    In addition, FDA uses a system called the Pet Event Tracking 
Network (PETNet) to share information about emerging pet-food-related 
illnesses and product defects. PETNet is a secure network launched in 
August 2011 that allows the exchange of information between FDA and 
other Federal and state regulatory agencies. Using the shared 
information, state and Federal agencies can work together to quickly 
determine what regulatory actions are needed to prevent or quickly 
limit adverse effects associated with pet food products.
    Finally, section 1002 of the FDAAA required FDA to establish 
processing standards for pet food. The process controls standards for 
pet food have been incorporated into the proposed rule, ``Current Good 
Manufacturing Practice and Hazard Analysis and Risk-Based Preventive 
Controls for Food for Animals,'' which, when finalized, will implement, 
for animal food, section 103 of the FDA Food Safety Modernization Act. 
The proposed rule, which issued on October 25, 2013, establishes 
requirements for the safe manufacturing, processing, packing, and 
holding of animal food to protect animals and humans from foodborne 
illness.
                               conclusion
    Thank you for the opportunity to describe FDA's ongoing efforts to 
determine a definitive cause of the reported pet illnesses associated 
with jerky pet treats. The Agency is devoting significant resources to 
actively investigate the problem and its origin. FDA continues to work 
in collaboration with a wide variety of experts, including our 
colleagues in academia and industry, our international counterparts, 
and Federal, state and university laboratories, on this investigation. 
If FDA's investigation leads to the identification of any particular 
jerky pet treat ingredient or contaminant that is associated with 
illnesses in pets, the Agency intends to act quickly to notify the 
public of its findings and take steps, as appropriate, to ensure the 
affected product is promptly removed from the market.
    FDA encourages consumers to check our website for updates on the 
ongoing investigation. As noted above, we will continue to remind pet 
owners that jerky pet treats are not necessary for a pet's healthy 
diet.
    I am happy to answer any questions you may have.
                                 ______
                                 

                  Prepared Statement of Shaun Kennedy

                             june 17, 2014
    Chairman Brown, Chairman Smith and distinguished members of the 
Commission, I would like to thank you for this opportunity to provide 
my perspective on current concerns with the safety of the food and feed 
system and potential steps to make it safer. I am the Director of the 
Food System Institute, LLC, a food system risk management and research 
firm and I have been focused on protecting our food system for years in 
prior positions as Director of the National Center for Food Protection 
and Defense, as Associate Professor of Food Systems in the Department 
of Veterinary Population Medicine at the University of Minnesota and as 
Vice President of Global Food and Beverage Research Development and 
Engineering for Ecolab.
    As is often the case, there are a number of ongoing public and 
animal health concerns that are related to potential food and feed 
contamination. The pet deaths that appear to be attributable to jerky 
treats imported from China have raised concerns among many that we are 
exposed to unknown risks due to imported food products and food 
ingredients. The most commonly identified type of treats are chicken 
jerky treats, which may also raise concern that the USDA's designation 
of China as an ``equal to'' country for processed poultry will expose 
consumers to additional unknown risks. The potential that the ongoing 
Porcine Epidemic Diarrhea virus (PEDv) outbreak in swine may be 
attributable, at least in part, to feed is another example of uncertain 
risk from food and feed. Among many possible solutions to these, and 
other, food system concerns are demands for increased regulatory 
inspection and clearer source labeling on consumers' packages, more 
commonly known as COOL or Country Of Origin Labeling. Before addressing 
either of those approaches, I would first like to provide a bit of 
context around our current food and agriculture system and what that 
implies for how either increased inspection or COOL could be 
effectively implemented.
    Everyone realizes that we are sustained by a global food and 
agriculture system, but it is often hard to conceptualize how global it 
really is. In the first four months of this year, January through 
April, we imported food and raw agricultural products from more than 
179 countries with a total value of over $48 billion and weighing over 
26 million metric tons. When we focus on food items classified as 
``consumer oriented'', which are products close to the form in which 
consumers would purchase them and not intermediate products like raw 
cocoa beans, we imported $23.5 billion and nearly 11 million metric 
tons of these products in the same four months. That is roughly 75 
pounds per person in the U.S. for the first four months of the year or 
over half a pound per day. So at a basic level, we are always eating 
foods that come from around the world as well as those from around the 
block, and that is something that has been steadily growing over the 
last decade. In 2004, our imports of ``consumer oriented'' products 
were only $12 billion and 8 million tons or about 56 pounds per person 
in the first four months of the year. Those imports come from a broad 
range of facilities, with over 6,800 USDA-FSIS approved domestic 
facilities and over 250 approved foreign facilities while over 81,000 
domestic and 115,000 firms are registered with the FDA to supply food 
to the U.S.
    A significant challenge any consumer faces is figuring out the 
origin of each ingredient in any particular meal, but it is easier to 
understand where it could have come from. If your lunch today was a 
cheeseburger, French fries and milk, the last two are fairly 
straightforward. We are a big producer of both fluid milk and frozen 
French fries, with only five countries exporting frozen French fries to 
the US and five countries exporting fluid milk. In both cases the 
dominant source is Canada. That doesn't necessarily mean that all 
components of these food items are domestically sourced, however, as 
Canada, Chile and Mexico have historically been exporters of salt to 
the U.S. that may be on the French Fries and the vitamins added to the 
milk are primarily imported from China and a few other countries. The 
cheeseburger is a bit more complicated as the bun, burger, cheese, 
tomato, lettuce, pickle, onion, ketchup, mustard and seasoning, ten 
consumer level items, can contain 75 or more individual ingredients. 
Last year those ingredients were imported to some degree from over 55 
countries. That means that, including domestic sourcing, the burger has 
billions of possible combinations of country of origin for its various 
ingredients.
    While any specific burger obviously has a dramatically smaller 
range of sourcing options, this simple lunch illustrates both the 
complexity of the food system and the hurdles of country of origin 
labeling. If it is winter, the lettuce and tomato are usually imported 
from Mexico and Central America. The ground beef is often a mix of 
domestic and imported sources, from Australia and other sources, to 
meet quality demands. The bun, ketchup, mustard and seasoning usually 
include imported ingredients from a number of countries, especially 
since many spices don't grow in our climate. While a company could 
verify what the country of origin was for each ingredient, under COOL 
the challenge becomes how to label and where to put this information? 
This is further complicated by the fact that sources, especially for 
seasonal ingredients, may change several times a year. Ingredients may 
also be comingled in entirely different ways in a relatively short time 
frame based on availability, cost or quality parameters. Clearly, 
accurate and informative labeling on country of origin is thus a 
challenge. With the increasing use of web based solutions, the only 
reasonable option might be to provide the information in something like 
a QR Code that you see on many consumer products that would take the 
consumer to a website for details that cannot be reasonably provided on 
the label. Whatever the solution, including the potential of reducing 
sourcing complexity to make COOL more easily achievable, there is an 
additional expense that would have to be added to the retail cost of 
the product, and consumers will ultimately bear the burden of the 
increased cost of foods reaching their table.
    The scale and complexity of the food system we depend on 
contributes significantly to the challenge of ensuring that our food is 
always safe and complicates our ability to rapidly figure out what has 
happened when something goes wrong. The pet deaths linked to pet treats 
from China illustrate these challenges. As a happy ``parent'' of Storm, 
an Aussie-doodle, the pet treat related deaths are personally 
troubling. Storm gets a little treat after our walk every night, so I 
have been following this ongoing concern closely. While the first cases 
were reported in 2007, no causative agent has yet been identified. This 
is even though FDA has conducted extensive testing of a broad range of 
treats, including treats provided by owners of pets who passed away, 
and no probable agent has been found. Without knowing what is causing 
the illnesses, and thus no means of screening products to ensure that 
they are safe, firms and authorities have limited options. Purina has 
moved to a dedicated, direct supply chain in China for its production 
of chicken pet treats. By controlling all aspects of production from 
hatching through slaughter and processing, Purina can better ensure the 
integrity and safety of their Chinese sourced chicken pet treats. Until 
we know what the cause of illness is, however, they don't have total 
assurance that this intensive effort has eliminated the potential for 
further illnesses.
    If the problem is a low-level contaminant where cumulative dose is 
the reason for the illnesses, it could unfortunately take much more 
time to figure out. There are more unknowns and uncertainties with 
respect to chronic versus acute toxicities, whether the food is 
intended for human or animal consumption. Chronic toxicity becomes even 
more important for both infants and pets who tend to have the same 
limited sets of foods over time so that a low level of contamination in 
the treats, something not considered an acute health risk, could lead 
to chronic illness with the steady dose of treats over time. 
Additionally, pets and infants also consume more food per pound of body 
weight than adults and often have a lower threshold for illness than 
adults.
    Regardless of whether the cause of illness was known, inspection 
and testing have limited utility in protecting public health for 
contaminants that are low-level and sporadic. Regulatory inspections 
and vendor audits have many benefits, including ensuring that the food 
safety system design meets regulatory or customer requirements. 
Inspections and audits also provide an awareness and education 
opportunity for all involved. They do not, however, provide an 
assurance of no probability of foodborne illness. If that were the 
case, there would never be an outbreak related to USDA inspected 
facilities since they have inspectors on site every day. In order to 
make sure that there are no deviations that could possibly lead to 
illness, it would require 100% inspection of every step from farm to 
table, and that is simply not achievable. Under the Food Safety 
Modernization Act (FSMA) the requirement is to inspect high-risk 
facilities at least every three years and other facilities every five 
years, and that is already well beyond the resources currently 
available to FDA. That is in part why third party audits are part of 
the FSMA framework, but even an annual inspection doesn't ensure that 
any individual food is safe.
    Similarly, for product testing to provide 100% assurance of no 
contamination would require testing of all servings of the product, 
leaving very little to actually eat. That is not to say that product 
testing isn't an important part of an effective food safety plan. 
Product testing provides a means of monitoring the food safety system 
to ensure that it is under control. The first step, however, is to know 
what to test for, and in the case of the pet treats that is still an 
unknown. Once you know what to test for, such as Salmonella in a meat 
or poultry product, you have to decide how you will test and what your 
sampling strategy will be. For example, for ready-to-cook poultry 
products the USDA requirement involves one sample per day over a fixed 
period of time period where an acceptable level is determined by having 
a prevalence of positive samples less than a predetermined performance 
standard. This testing approach can potentially be improved by 
quantifying the amount of contaminant in the product. This enumeration 
approach adds value because toxicity or infectivity is based on 
ingestion of a sufficient dose of pathogen. Consequently, knowing that 
one source or point in the system has infrequent, but significant or 
high level contamination can be far more valuable than knowing that all 
sources or points have low, infrequent contamination. This is 
especially the case for ready-to-cook products where some level of 
foodborne illness organisms is acceptable.
    Since the pet treats of concern are sourced from China there is 
heightened concern about the granting of ``equal to'' status for 
processed poultry from China that was approved last year. It is 
important to recognize that this was not a capricious decision by USDA, 
but instead the next step in a process that began a decade ago. Under 
the provisions of the World Trade Organization, a country can require 
any scientifically justifiable safety standards to protect its public 
so long as the requirements are equivalent for domestic and foreign 
firms. That is precisely what USDA has done, and it is why poultry 
slaughter in China is not yet granted ``equal to'' status as the 
Chinese regulatory system and facilities have not yet been found to be 
``equal to'' those in the U.S. That does not mean that consumers are 
going to be exposed to dramatically new foodborne illness threats when 
processed poultry from China begins arriving in the U.S. In the last 
four years there have been five multi-state foodborne illness outbreaks 
associated with U.S. poultry, so there is already some level of 
foodborne illness risk associated with poultry. I can tell you that one 
of the absolute best poultry plants I have every conducted an audit on 
was in China. That facility's food safety system was driven more by its 
company's standards and customer expectations than any regulatory 
requirements, and that is very common both domestically and overseas. 
While there may be some baseline risk of illness due to consumption of 
food from any of the more than 179 countries we import food from, as 
was the case for that Chinese poultry facility, the real answer lies in 
the specific food systems and how they are managed. That is one of the 
strong points of FSMA as it will require firms to ensure that their 
suppliers, wherever they are, are meeting FDA requirements and thus 
some level of importer/supplier information sharing, directly or 
through the exporter, will have to occur. In addition, firms need to go 
beyond that minimum to certify that their suppliers meet the unique 
requirements of the intended finished product, and most firms already 
do that.
    A different type of food and feed safety concern has been raised by 
the ongoing Porcine Epidemic Diarrhea Virus (PEDv) outbreak in the 
swine industry. Rabobank, a leading banking and financial firm focused 
on food and agriculture, has estimated that PEDv has impacted 60% of 
the U.S. sow heard and may reduce pork production by up to 7%. This 
would be the lowest pork production in the U.S. in over 30 years. While 
the pathway for PEDv spread to farms has not been confirmed, feed, or 
how the feed gets to the farm, has been strongly implicated. Swine 
transportation vehicles have also been identified as a potential 
source. Testing to date, however, has not been able to confirm that 
PEDv contaminated feed has been the source of any specific outbreak or 
that there is broad contamination of feed or feed ingredients with 
PEDv. This situation further illustrates the challenges of both testing 
as an intervention strategy and the current feed system complexity. 
Unlike the pet treat problem, with PEDv it is not just the animal that 
eats the feed that will get sick. Since an individual pig that gets ill 
can further spread the disease to others in its herd, it only takes a 
fraction of a herd to initially contract the virus for it to infect a 
large portion of the herd. Given that PEDv has a relatively low 
infective dose, it would thus only require low level, sporadic 
contamination of the feed, a feed ingredient or its packaging to spread 
the virus broadly. So even a robust testing strategy that was capable 
of detecting live virus at a very low level of every batch of feed 
could not match the effective sampling strategy of then providing the 
feed to tens of thousands of pigs where only a few of the servings 
would have to be contaminated for the virus to spread.
    Whether the source is a feed ingredient or ingredient packaging, 
finished feed or transportation of feed to farm that turns out to be 
the source of the outbreak, the scale and complexity of the feed system 
makes solving the problem a challenge. For example, there are over 
1,140 production-animal feed mills in the country so if the source is a 
feed ingredient, following a particular ingredient from its production 
to consumption and then matching that to geographic patterns of illness 
becomes very complicated. Just as is the case for almost every other 
final food product, there is no one place where all of the information 
on how the global food and agriculture system puzzle pieces fit 
together is maintained. Through their agreements with their suppliers, 
however, firms are in the best position to do this for their own 
products, regardless of what country they or their suppliers are 
located in. Supply chain visibility then becomes part of a firm's PEDv 
mitigation strategy.
    To summarize, the ongoing association of pet deaths with Chinese 
sourced animal treats is understandably raising concerns. Until the 
actual cause of the illnesses is understood, however, inspections upon 
import or product recalls provide no assurance of greater safety. Even 
when the source is understood, it will likely still be more effective 
for firms to manage their supply chains to mitigate continued exposure 
than to expect import testing to prevent entry of any possibly 
contaminated treats. While there are many who are concerned about the 
prospect of allowing poultry processed in China to gain entry into the 
U.S. market, the approval is fully consistent with the current laws, 
regulations and international agreements. There are already some very 
good poultry production facilities in China, so, as is the case for 
domestic sourcing, with appropriate due diligence importers will have 
the ability to maintain the safety of their poultry products sourced in 
China. For both domestically produced and foreign sourced poultry, 
especially ready to cook poultry, the food safety system could be 
further strengthened by including enumeration of potentially pathogenic 
bacteria to the current prevalence approach. If the feed system is 
proven to be the means by which PEDv is spread to swine herds, sampling 
and testing of feed and feed ingredients will be a necessary but 
insufficient means of protecting the swine industry. Testing can 
provide assurances that the system is behaving as intended, but first 
the system has to be designed so that the potential for contamination 
has been mitigated in the first place. In each case, a firm's supply 
chain visibility is an important part of the food and feed safety 
strategy.
    Ensuring that our food safety standards are met at every step from 
farm to consumer, pet or farm animal in the global food and agriculture 
system is a daunting challenge. While the enabling laws and regulations 
are different between the agencies within a country and between 
countries, they share to basic goal of preventing illness. On a day-to-
day basis the responsibility of achieving that goal is taken up 
primarily by the firms themselves, with the oversight and support of 
their local regulatory authorities, as they have the visibility and 
control of their supply chain and facilities to do so. While overall 
the food and agriculture system does a remarkable job of safely feeding 
us, we should do better. Through effective partnerships across 
stakeholders, from industry to authorities to the research community, 
the encouraging thing is we can.
                                 ______
                                 
 [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]         
                                 

              Prepared Statement of Christopher J. D'Urso

                             june 17, 2014
                              introduction
    According to President John F. Kennedy in his ``Special Message to 
the Congress on Protecting the Consumer Interest'', ``If the consumer 
is unable to choose on an informed basis, then his dollar is wasted, 
his health and safety may be threatened, and the national interest 
suffers'' (Kennedy). Unfortunately, this key tenet of consumer rights 
has been undermined by weak country of origin labeling (COOL) laws. 
Under the Tariff Act of 1930 and the Farm Bills of 2002 and 2008, 
imported products must be clearly labeled with country of origin. 
However, these laws contain a disturbing exemption which has been 
exploited and misconstrued by businesses: any imported product that is 
processed in the U.S. is not required to have COOL. Consequently, the 
majority of products remain unlabeled (Jurenas). As imports continue to 
increase, these inadequate laws not only compromise the consumer's 
right to know but also pose a threat to the public health and economy 
of the U.S. Thus, COOL must be required for all food products (defined 
as both human and pet), pharmaceuticals, and dietary supplements.
                     issues with current cool laws
    The aforementioned COOL laws do not define what constitutes 
processing. Thus, U.S. Customs and Border Patrol, which enforces the 
Tariff Act for pharmaceuticals and dietary supplements, has broadly 
defined processing to be any method which results in the substantial 
transformation of a product whereby the product experiences a change in 
name, character, or use (Country of Origin Marking). On the other hand, 
the Agricultural Marketing Service (AMS), which enforces the Farm Bills 
for food products, has defined processing to be any type of cooking, 
curing, mixing, smoking, or restructuring (e.g. emulsifying and 
extruding). The interpretations of these agencies are highly 
subjective, loosely defined, and possibly contradictory. For instance, 
AMS has broadly construed their interpretation of processing to include 
mixing peas with carrots, roasting peanuts or pecans, and breading meat 
(Jurenas). Equally disturbing, chicken that is slaughtered in the U.S. 
can be exported to China for processing and subsequently re-exported to 
the U.S. as a nugget or soup without COOL (Strom). As a result of such 
loose standards, only 11% of pork, 30% of beef, 39% of chicken, and 40% 
of fruits and vegetables may be required to have COOL (Jurenas). The 
balances are either produced in the U.S. or imported and processed in 
the U.S. However, consumers will not know which is the reason. 
Therefore, Secretary of Agriculture Tom Vilsack has acknowledged that 
COOL exemptions ``may be too broadly drafted'' (qtd. in Jurenas).
                          imports to the u.s.
    Compounding the issue of weak COOL laws, imports in 
pharmaceuticals, dietary supplements, and foods have reached all-time 
highs and are rapidly increasing. In the U.S. pharmaceutical industry, 
growth in the prescription drug market has flattened and the rate of 
return on pharmaceutical investments has dropped to just above the cost 
of capital. Coupled with demand for lower-cost products, these trends 
have caused a relocation of production to less developed nations such 
as China and India where the cost of formulation of an active 
pharmaceutical ingredient (API) can be 15-40% cheaper. Consequently, 
imports of pharmaceuticals increased by 13% annually from 2004 to 2011. 
Especially distressing, 10-15% of all food, including 60% of fruits and 
vegetables and 80% of seafood are imported (Pathway). As imports 
continue to rise so does the need for explicitly defining exemptions 
and strengthening COOL laws.
                        consumers' right to know
    Weak COOL laws significantly undermine the right of consumers to be 
informed and make educated decisions. President Kennedy recognized this 
inalienable right as part of the Consumer Bill of Rights he presented 
in his Special Message to the Congress on Protecting the Consumer in 
1962 (Kennedy). These rights were later codified in the United Nations 
Guidelines for Consumer Protection which affirm the consumer's right to 
``adequate information to enable them to make informed choices 
according to individual wishes and needs'' (Guidelines). Without strong 
COOL laws, consumers are stripped of their right to know and thus their 
ability to avoid products from countries with poor quality or 
workmanship, inadequate safety regulations, human rights violations, or 
environmental concerns.
                   safety and public health concerns
    Weak COOL laws place American public health at undue risk. 
According to the Food and Drug Administration (FDA), imports from 
developing countries such as China are increasing faster than imports 
from developed countries. Specifically, China is expected to see a 40% 
increase in exports by 2020 and 9% annual growth in food exports 
between 2010 and 2020 (Pathway). Unfortunately, China suffers from 
lower quality standards and compliance, lack of government oversight 
and regulation, and inadequate or inconsistent testing procedures. 
According to Dr. Peter Ben Embarek, food safety expert with the World 
Health Organization, ``[Chinese food safety inspectors have] no clue 
what are the major food-borne diseases that need to be addressed or 
what are the major contaminants in the food process''. Dr. Embarek 
elaborates that China uses a long-discredited method of randomly 
sampling and testing products (qtd. in LaFraniere). Furthermore, the 
U.S. Department of Agriculture notes that ``refusals of food shipments 
from China suggest recurring problems with filth, unsafe additives . . 
. and veterinary drug residues'' (Gale and Buzby).
    Alarmingly, the FDA inspects only 1% of foreign shipments destined 
for the U.S. (Gale and Buzby). Equally distressing, the FDA admits that 
it ``does not--nor will it--have the resources to adequately keep pace 
with the pressures of globalization''. Specifically, it does not have 
sufficient resources to fully inspect foreign facilities, and it is 
impossible for them to meet the recommendations of the Government 
Accountability Office. In fact, the FDA has only inspected 1.5% of 
Chinese seafood processors selling to the U.S. At the current rate, it 
would take nine years for the FDA to inspect every high-priority, 
foreign pharmaceutical facility just once (Pathway).
    Without FDA oversight and inspection, consumers are left vulnerable 
and are forced to protect themselves. This can be achieved through the 
use of COOL where consumers can avoid products from countries with 
known health and safety issues. Additionally, COOL provides 
traceability which may make it easier to address recalls and mitigate 
outbreaks of food-borne illnesses. For instance, COOL could have been 
implemented to combat the outbreak of mad cow disease in 2003-2005 
since consumers would have had the information to avoid Canadian meat 
(Jurenas).
                            economic impact
    Weak COOL laws may cause consumers to unknowingly purchase foreign 
products. Consequently, U.S. companies may lose business, American jobs 
may be eliminated, tax revenues may be reduced, dependency on imports 
may increase, and the U.S. trade imbalance may be exacerbated. On the 
other hand, U.S. companies will benefit from strengthened COOL laws 
since consumers will be more likely to purchase products labeled Made 
in USA. For example, a Florida Department of Agriculture and Consumer 
Services survey revealed 62% of consumers would purchase a product 
labeled Made in USA (VanSickle, et al.). As a result of the 
implementation of COOL in 2008, Canadian hog imports decreased 31% in 
the first year while Canadian and Mexican cattle imports decreased 10% 
each year from 2007 to 2009 (Jurenas).
    Equally important, consumers may also be willing to pay a premium 
for products labeled Made in USA. In a study published by Colorado 
State University, 73% of consumers were willing to pay a 19% premium 
for ``USA Guaranteed'' steak and a 24% premium for ``USA Guaranteed'' 
ground beef due to safety concerns regarding imported beef, a strong 
desire to support U.S. producers, or beliefs that U.S. beef is of 
higher quality (Umberger, et al.). Based on these findings, the 
University of Florida estimated that implementing COOL would increase 
annual profits by $900 million for the U.S. steak industry and $3 
billion for the U.S. ground beef industry (VanSickle, et al.). 
Similarly, in a study by The Boston Consulting Group, 80% of consumers 
were willing to pay 10-60% more for a variety of products labeled Made 
in USA even when imported products were cheaper (U.S. and Chinese 
Consumers). In another study published by Colorado State University, 
consumers were also willing to pay an increase in taxes of $183.77 per 
year to support mandatory COOL (Loureiro and Umberger). As a result of 
strong consumer preference for products labeled Made in USA, 
strengthened COOL laws will bestow undeniable benefits on American 
businesses and the economy.
                        international trade laws
    Despite charges of protectionism, the World Trade Organization 
(WTO) has recently affirmed the right of countries to mandate COOL, 
especially for food products. Under Article IX of the General Agreement 
on Tariffs and Trade, WTO members are allowed to adopt laws requiring 
COOL to protect consumers (General Agreement). This provision was the 
subject of a WTO dispute in November 2009 when Canada and Mexico 
challenged U.S. COOL laws as unfairly discriminating against their 
products, causing their hog exports to the U.S. to decline (Jurenas). 
The Appellate Body ruled that mandatory COOL does not violate the 
Technical Barriers to Trade (TBT) Agreement. According to the Appellate 
Body, it did not matter if COOL laws ``have a detrimental impact on 
imports''. Instead, the determining factor is if COOL laws ``stem 
exclusively from a regulatory distinction rather than reflecting 
discrimination against the group of imported products''. Based on this 
reasoning, the Appellate Body ruled that U.S. COOL laws needed to be 
rewritten since ``COOL's recordkeeping and verification requirements . 
. . impose a burden on upstream producers and processors that is 
disproportionate to the level of origin information conveyed to 
consumers'' (qtd. in Ray and Schaffer). Originally, the labeling 
requirements at issue were weak since they did not require the 
disclosure of where the meat was born, raised, and slaughtered. As a 
result of this ruling, the U.S. was forced to enact stronger laws that 
required the explicit statement of where the aforementioned stages or 
steps occurred (Ray and Schaffer).
                               conclusion
    Incontrovertibly, weak COOL laws not only undermine consumer rights 
but also pose a threat to the U.S. public health and economy. Current 
laws do not require domestic products or imported products that are 
processed in the U.S. to have COOL. These exclusions have been too 
broadly construed to exempt the majority of imported foods, 
pharmaceuticals, and dietary supplements. As imports of these products 
continue to increase, strong COOL laws are vital now more than ever 
before. Strong COOL laws preserve consumer rights by enabling people to 
make informed purchasing decisions. Additionally, strong COOL laws 
safeguard the public health by allowing consumers to avoid potentially 
unsafe imports and by providing vital traceability. Furthermore, strong 
COOL laws will confer irrefutable benefits to American companies as a 
result of consumer preference and willingness to pay premiums for 
products labeled Made in USA. Despite charges of protectionism, the WTO 
has repeatedly affirmed the rights of countries to enforce COOL laws.
    Unfortunately, the broad and inconsistent interpretations of 
exemptions to COOL laws increasingly affect my generation as the world 
becomes globalized, moving toward one market where supply chains are 
exceedingly complex. Moreover, my generation thrives on having 
immediate access to information so that we can express our preferences 
such as not purchasing products from countries with safety issues, 
human rights violations, or environmental concerns. Consequently, the 
processing exemption to mandatory COOL must be explicitly and 
objectively defined by law in order to eliminate loopholes, room for 
interpretation, and possible contradictions. Equally important, all 
food products, pharmaceuticals, and dietary supplements, both foreign 
and domestic, must be required to have COOL.
                              works cited
    ``Country of Origin Marking.'' Electronic Code of Federal 
Regulations. U.S. Government Printing Office, n.d. Web. 2 Jun. 2014.
    Gale, Fred and Jean C. Buzby. ``Imports from China and Food Safety 
Issues.'' Economic Research Service. United States Department of 
Agriculture, Jul. 2009. Web. 2. Jun. 2014.
    ``General Agreement on Tariffs and Trade.'' World Trade 
Organization. World Trade Organization, Jul. 1986. Web. 14. Jul. 2013.
    Jurenas, Remy. ``Country-of-Origin Labeling for Food.'' 
Congressional Research Service. Library of Congress, 4 Jul. 2010. Web. 
1 Jun. 2013.
    Kennedy, John F. ``Special Message to the Congress on Protecting 
the Consumer Interest.'' The American Presidency Project. The Regents 
of the University of California, n.d. Web. 19 Jul. 2013.
    LaFraniere, Sharon. ``In China, Fear of Fake Eggs and `Recycled' 
Buns.'' The New York Times. The New York Times Company, 7 May 2011. 
Web. 14 Jul. 2013.
    Loureiro, Maria, and Wendy Umberger. ``Estimating Consumer 
Willingness to Pay for Country-of-Origin Labeling.'' Journal of 
Agricultural and Resource Economics 28.2 (2003): 287-301. Web. 1 Jun. 
2013.
    ``Pathway to Global Product Safety and Quality.'' U.S. Food and 
Drug Administration. U.S. Department of Health and Human Services, 7 
Jul. 2011. Web. 1 Jun. 2013.
    Ray, Daryll, and Harwood Schaffer. ``COOL Itself is Not Ruled 
Illegal by WTO but Finds Label Wording to Be a Problem.'' Agricultural 
Policy Analysis Center. The University of Tennessee, 22 Mar. 2013. Web. 
19 Jul. 2013.
    Strom, Stephanie. ``Chinese Chicken Processors Are Cleared to Ship 
to U.S.'' The New York Times. The New York Times Company, 30 Aug. 2013. 
Web. 30 Aug. 2013.
    Umberger, Wendy, et al. ``Country-of-Origin Labeling of Beef 
Products: U.S. Consumers' Perceptions.'' Journal of Food Distribution 
Research 34.3 (2003): 103-116. Web. 1 Jun. 2013.
    ``United Nations Guidelines for Consumer Protection.'' United 
Nations Sustainable Development Knowledge Platform. United Nations, 
2003. Web. 1 Jul. 2013.
    ``U.S. and Chinese Consumers Willing to Pay More for Made in USA 
Products.'' The Boston Consulting Group. The Boston Consulting Group, 
15 Nov. 2012. Web. 19 Jul. 2013.
    VanSickle, John, et al. ``Country of Origin Labeling: A Legal and 
Economic Analysis.'' Institute for Agriculture and Trade Policy. 
Institute for Agriculture and Trade Policy, May 2003. Web. 1 Jun. 2013.
                                 ______
                                 

  Prepared Statement of Hon. Sherrod Brown, a U.S. Senator From Ohio; 
         Chairman, Congressional-Executive Commission on China

                              june 17, 2014
    We have called this hearing to seek answers for American consumers, 
pet owners, farmers, and parents about the safety of pet treats, 
processed chicken, and animal feed from China.
    Americans want to know where their foods come from and want to make 
sure that everything is being done to keep it safe.
    Sixty-two million households in this country have a pet. They are 
raising 83 million dogs and 96 million cats just like members of their 
family.
    That's why it's so troubling that seven years on, we still do not 
know what's causing the deaths and illnesses of thousands of dogs. Just 
last month, the FDA said that reports of illnesses had increased to 
5,600 pets, including 1,000 dog deaths, and now three human illnesses. 
While no cause has been identified despite extensive study, the 
illnesses may be linked to pet treats from China.
    Days later, major pet stores Petco and Petsmart announced they 
would be phasing out the sale of pet treats from China out of safety 
concerns.
    Many of us still remember the pet food scare and recalls of 2007, 
the result of melamine-tainted pet food from China.
    Given this, pet owners in Ohio and across America are rightfully 
concerned. When they go to the store to buy treats and food for their 
pet, they face difficult and confusing questions, just like the ones 
our family faces for our dog Franklin.
    If something says it's made in China, can we be assured that it is 
safe? If it says it's made in the USA, what exactly does that mean? Is 
everything being done to keep pet treats safe?
    Last year, the USDA declared that China is eligible to export 
processed, cooked chicken to the United States, paving the way for 
chicken sourced in the United States to be shipped to China for 
processing and then sold back to American consumers.
    While no such chicken has entered our shores yet, it's possible 
that very soon this processed chicken could end up on our dinner tables 
and in our school lunchrooms.
    Can we trust our Chinese counterparts to enforce safety up to our 
own standards, given China's poor enforcement of their own laws and 
rampant corruption? Will the label clearly indicate that the chicken 
was processed in China, so Americans can make an informed choice?
    And finally, researchers are exploring a possible link between 
animal feed from China and the Porcine Epidemic Diarrhea Virus (PEDv) 
that has wiped out some 10 percent of our pig population. It's been a 
year and no definitive cause has been identified.
    Americans want and require better answers, clearer labels, and the 
peace of mind that the foods we import from China are safe.
    I appreciate the FDA and USDA being here to shed more light on 
these issues and to help American consumers better understand them.
    In the meantime, I would urge the Chinese government to fully 
cooperate with our agencies and to make significant improvements in 
their food safety system.
    And I would urge our FDA and USDA to continue devoting every effort 
to determining the cause of the pet illnesses and PEDv.
    I urge companies to ensure the highest safety standards and to put 
pet and human safety first.
    Finally, I would also urge us in Congress to consider whether we 
need to update our labeling requirements to take into account an 
increasingly globalized marketplace and to ensure the public health of 
our citizens.
                                 ______
                                 

  Prepared Statement of Hon. Christopher Smith, a U.S. Representative 
  From New Jersey; Cochairman, Congressional-Executive Commission on 
                                 China

                             june 17, 2014
    Thank you very much, Chairman Brown. Thank you for calling this 
important hearing. I want to welcome our distinguished witnesses to 
this hearing on the important issue of the safety of our food products 
from China.
    This is the second hearing on food safety that the Commission has 
done in the past year, and I especially want to thank Chairman Brown 
and our very dedicated and professional staff for their work to raise 
awareness about this issue, as well as all other human rights, rule of 
law, and governance issues.
    The safety of food, feed, and drugs from China are a cause of real 
concern. American consumers are rightly anxious. We have pet treats 
that may have sickened and/or killed many pets across America. A virus 
may decimate 10 percent of American pigs, possibly from vitamins or 
feed from China. We have food products, including processed chicken, 
that may not have labeled as being made in China. In fact, it may have 
been labeled ``Made in America.''
    I want to thank Chris D'Urso for bringing this last issue to my 
attention. The maze of labels and labeling requirements called Country 
of Origin Labeling makes it difficult for American consumers to make 
reasoned choices about the foods they eat and those foods that they 
feed to their pets.
    Christopher D'Urso is one of the most outstanding young men that I 
have encountered. Not only did he achieve a perfect SAT score and 
ranked number one in his class, but his record of public service at 
such a young age is extraordinarily rare.
    Last year we met and he brought information to me and to my staff, 
and to the Commission staff, about his research and findings regarding 
Origin of Labeling laws for the United States. The thoroughness and the 
level of understanding in such a complex and international issue was 
indeed impressive.
    Having researched this issue since 2012, he pointed to the 
inadequacies of many of our current laws. In fact, consumers have the 
right to know the country of origin products, especially when they eat 
those products. I believe his future contributions will be significant.
    On the issue of food safety, both Chinese and American consumers 
share serious concerns about food products made in China. I know I 
look, but again, we don't always know that what we're looking at is 
actually the truth. We really hope there can be more cooperation, 
accountability, and transparency in the future.
    This past week was food safety awareness week in China. China's 
food industry has faced a real crisis of confidence over the past seven 
years. Despite government efforts, the number of scandals continue to 
grow: Meat that glows in the dark; exploding watermelons; 40 tons of 
bean sprouts containing antibiotics; rice contaminated with heavy 
metals; mushrooms soaked with bleach; and pork so filled with 
stimulants that athletes were told not to eat them, they would test 
positive for banned substances. All on top of the melamine-tainted milk 
powder that sickened some 300,000 children in 2007. As we all know, the 
World Health Organization [WHO] has said that melamine can cause kidney 
failure, bladder and kidney stones, and even may be a carcinogenic.
    In response to that scandal, China passed its first ever food 
safety law. Nevertheless, we all know well that there is often a gap 
between what Chinese law says and what is enforced. China is still 
struggling to keep its food supply healthy.
    The Chinese government is trying to crack down, we are told, 
recently closing some 5,000 food-producing businesses and arresting 
over 2,000 people. But experts on food safety say a needlessly complex 
bureaucracy and fierce determination to turn a profit means there will 
continue to be food safety scares and a Chinese public wary about its 
own supply.
    While we think that this issue would have been solved already if 
China transferred resources to food safety from censoring the Internet 
and cracking down on free speech and political dissent, unfortunately, 
the government still seems to want safe pork but a silent public.
    There is a direct connection between better human rights conditions 
in China and food safety. While China has had unprecedented economic 
growth for decades, it lags behind in ensuring the rights of its 
citizens and in developing transparency, official accountability and 
rule of law, things it certainly needs to tackle like the issue of food 
safety.
    Transparency is absolutely necessary for any government to protect 
the health and well-being of citizens and to effectively manage 
problems related to food and drug safety. Remember the secrecy about 
the SAARS? Free speech and free press and freedom of association would 
allow crusading journalists in civil society to expose health scandals 
and work toward open solutions.
    Those who try to skirt the law for profit would be exposed and 
citizens could work together with their government to ensure better and 
healthier food and water. A free press and muckraking journalists and 
novelists like Upton Sinclair--who we all recall wrote The Jungle about 
unsanitary meat, and it led to the Pure Food and Drug Act of 1906, that 
eventually morphed through legislation into the FDA--certainly helped 
to bring better food safety to the United States.
    It may be tempting to say that China is on a learning curve that 
will eventually produce better food safety. But they need journalists, 
they need people who can speak out, use the Internet, and expose what 
is happening.
    Let me conclude by saying U.S. trade policy must put health and 
safety of U.S. consumers and their pets as its top priority. Safety 
before profits is the message that has to be sent to producers, 
processors, and manufacturers.
    If U.S. inspections are blocked or delayed for any reason, we 
should consider swiftly pulling products from shelves. In addition, the 
United States must tell authorities in China that they are held 
accountable for implementing and enforcing laws on food and drug 
safety.
    The United States should be negotiating as part of its diplomatic 
relations better and smarter inspections, again, transparency in the 
food and drug supply chain, and closer collaboration between our food 
safety experts. Our labeling of food and feed products must be clear so 
that consumers know what they are buying and from whom, and where it 
comes from.
    Last, the United States must continue to make human rights a top 
priority of U.S.-China relations, free speech, and an active civil 
society will do much more to ensure safer food and expose corruption.
    I yield back, and I thank you.

                       Submission for the Record

                              ----------                              


  Testimony Submitted for the Record by Terry Safranek, Representing 
            Animal Parents Against Pet Treats Made In China

                             june 17, 2014
    Chairman Brown, Co-Chairman Smith, and Members of the Commission. 
My name is Terry Safranek and I live in Brooklyn Heights, Ohio. I 
represent a group that I helped found called Animal Parents Against Pet 
Treats Made In China. We welcome this opportunity to make this 
statement today. We commend your leadership for holding this very 
important and timely hearing. I want to specifically thank Senator 
Brown for his dedication to this issue. I am so proud that he is my 
senator when I share with the group all of his actions, and how he has 
never given up or given in. They all call Senator Brown ``Our 
Senator''.
    One month ago Petco and PetSmart--the nation's two largest 
specialty pet stores--announced that they would stop selling pet treats 
made in China. The announcement came on the heels of the FDA's latest 
report on victims of jerky from China. Unfortunately, this announcement 
came two and half years too late for my buddy Sampson.
    In December of 2011, my little Sampson, a healthy, lively and 
hilarious fox terrier mutt was showing signs that he was not well. He 
seemed withdrawn, and his appetite was decreasing, and all he wanted 
was to drink water and urinate. His health rapidly decreased. We took 
him to the veterinarian 3 times in the next two weeks. Finally, blood 
tests revealed horrible results. Sampson was in acute renal failure. 
The Doc gave him intravenous fluids for 6 long, tormenting days. And 
then, the agonizing decision, the hardest, most heartbreaking decision. 
With my husband and children around us, I held my little buddy in my 
arms for the last time, as he was euthanized.
    One day during this time, I saw a local family on the news, holding 
up a bag of Waggin' Train Chicken Jerky Treats! Their dog had eaten 
them died of renal failure a few weeks earlier, and their new little 
puppy was fed leftovers from the same bag--and became ill right away. 
As soon as they stopped the treats, he recovered. I was floored. It was 
the exact same treat that Sam had eaten; it had been his new favorite, 
and I was giving him them as a treat for about a month. I'm sure that 
was the only major change in his diet.
    I went to the Waggin' Train comment boards, and there were hundreds 
of people furiously recounting their experience, begging for answers. 
Each of us was shocked to find we weren't alone, and the stories 
unmistakably similar. Shocked to find that the companies would accept 
no responsibility, even blamed US for overfeeding the treats! AS IF 
it's okay for a dog to be killed--by a treat!?
    It was there that I met the pet parents of Bella, Ginger, Sophie, 
Heidi, Sarge, Shelbie and Annie, who would become my colleagues in this 
fight to protect other pets from this danger. Together we formed Animal 
Parents Against Pet Treats Made In China (APAPTMIC), a Facebook group, 
and a place for victims to gather, to share their stories, investigate 
the issue and make change.
    Meeting all of these grieving pet parents made us realize how 
widespread the problem was. Each of these little ones suffered 
terribly, and we are devoted to being there to support their families, 
and help them to deal with the tragedy--and the overwhelming guilt at 
being a part of their senseless poisoning.
    Together our little group began a journey that would lead us down 
many paths--in which we were complete novices. What we thought would be 
simple, turned into a herculean task. In our naivety we thought that 
the FDA would see all of these victims, with a clear connection to 
jerky from China and issue a recall. Nothing could be further from what 
actually happened.
    Most disheartening of all, we learned that the warnings were there. 
Although the FDA has issued numerous cautions and alerts, they were 
unable to force a recall as they had not--still have not--identified 
the exact toxin. But is there a single toxin? Or is the issue a 
systemic one that is based in China? After all this time, and after ALL 
of the rigorous research, it is our conclusion that it is a systemic 
issue.
    During these last two and a half years, we have watched the deaths 
associated with imported jerky treats climb to the current number of 
over 1000. 1000 deaths! More than one beloved pet was dying a horrible, 
painful death every single day in this country. Official figures 
indicate that 5,600 dogs, 24 cats, and 3 humans have become sick from 
contaminated jerky treats made in China. And how many thousands, tens 
of thousands, or more have gone unreported. How many have never made 
the connection?
    We needed to raise awareness. We needed to figure out what we could 
do to STOP the senseless pet deaths caused by Chinese jerky. Not only 
has my group committed countless hours to research, we have rallied and 
lobbied for change that would bring about an end to the deaths and 
illnesses our pets have suffered because of these imported treats. Some 
of the actions we have taken include:

         Petitions targeting Nestle Purina, retailers and the 
        FDA.
         Letter writing campaigns to manufacturers, retailers, 
        veterinarians, media outlets and the FDA
         Became named plaintiffs in the nationwide Class Action 
        lawsuits
         Attended and presented at Congresswoman DeLauro's 
        Congressional Briefing on Chicken From China.
         Met with FDA representatives Tracey Forfa, Deputy 
        Director of the Center for Veterinary Medicine and Sharon 
        Natanblut, Senior Advisor for Strategic Communications and 
        Public Engagement, FDA Office of Foods and Veterinary Medicine.

    Although there had been no recall, we know that the FDA WAS making 
an effort. They weren't just publishing obscure warnings on their 
website. They enlisted the Veterinary Laboratory Investigation and 
Response Network (Vet-LIRN), the CVM, a network of veterinary labs and 
even NASA, but have yet to find a specific problem. We understand that 
many FDA officials were also genuinely frustrated. Bernadette Dunham, 
FDA's Director of the Center for Veterinary Medicine, refers to the 
investigation as ``One of the most elusive and mysterious outbreaks 
we've encountered''.
    In January 2013, the New York State Department of Agriculture & 
Markets (NYSDAM) found illegal antibiotic residue on the treats. This 
caused a ``voluntary withdrawal'' of three of the most consumed and 
most complained about brands: Nestle Purina's Waggin' Train and Canyon 
Creek Ranch (all varieties) and Del Monte's Milo's Kitchen (2 
varieties). We were cheered to know that, at long last the deaths and 
illnesses being reported to the FDA would decrease substantially. But 
it was still hard to understand why the FDA wasn't more aggressive, 
when there is clearly a link of jerky treats to pet illnesses. The 
anecdotal evidence seems overwhelming.
    We decided to tackle the problem that each and every victim we knew 
had faced: if only I had known what the FDA knew! Our dogs were dead or 
suffering chronic illness because we didn't know there was a problem.
    Perhaps the most important of our actions is the petition asking 
the FDA to implement Section 211 of the Food Safety Modernization Act 
(FSMA), called FDA: POST CONSUMER NOTICES WHERE WE CAN SEE THEM. The 
FDA has always claimed their hands are tied when it comes to warning 
consumers about reported products at the point of sale, but this is no 
longer true. In 2011, Congress finally enacted the Food Safety 
Modernization Act (FSMA) which explicitly gives the FDA this authority. 
But of course, it is never that simple. Ever since that time, the law--
which encompasses all food, for pets or humans--was sitting in of the 
Office of Management and Budget waiting for review.
    With just a simple piece of paper posted on store shelves, millions 
of American families can be spared the consequences of purchasing 
potentially dangerous products. We believe that the FDA has the 
responsibility to inform consumers of possible risks and we have the 
RIGHT to make informed decisions. A trip to the grocery store should 
not be deadly!
    We strongly believe that Section 211 of the FSMA needs to be 
implemented as quickly as possible. If only we would have been warned 
at point of sale, we might have been spared the many, many tears we 
have shed, grieving our lost dogs.
    Imagine our devastation when it was announced in March of 2014 that 
Nestle Purina was returning Waggin' Train--the most reported brand 
associated with complaints of illness and death, to the market. The 
product is STILL MADE IN CHINA. From the Waggin' Train website Q & A: 
``As we said back in January 2013, we planned to re-introduce products 
once we determined the best way to address the regulatory 
inconsistencies between countries that led to the voluntary 
withdrawal.'' What does that even mean? Did they simply get the rules 
changed? This is truly frightening.
    If we have learned anything, it is that consumers desperately need 
the protection of the US government against these multi-national mega-
corporations, whose ultimate loyalty is to profit. As consumers, we 
don't stand a chance without the weight of the government behind us.
    Since April of 2012, several nationwide class action lawsuits have 
been working their way through the courts. The first, largest and most 
visible is Adkins v. Nestle Purina PetCare Co. Two years later, an 
agreement was reached. Nestle Purina PetCare Co. agreed to create a 
$6.5 million settlement fund to compensate dog owners who claim that 
their animals were harmed by their jerky treats from China. As of this 
writing, this agreement has not yet been finalized, awaiting approval 
of the Court.
    The Quality Assurance and Quality Control stipulations in the 
agreement are a crucial part of the agreement. Enhanced labeling and 
testing, and holding these companies accountable for the health and 
safety of their customers is the goal. But all of this is just a small 
piece of a huge puzzle.
    In our stores and across the country, people are waking up to the 
risks of chicken from China. But not enough have the knowledge that 
they require to make an educated choice. This is why we are so 
passionate about strengthening the FDA and the FSMA. There are too many 
loopholes that allow hazards to reach our homes and families. This is 
our last line of defense!
    It seems that government rules and regulations are endless, so we 
are concentrating on the few that we feel would have avoided such 
needless suffering:

         IMPLEMENT FSMA SECTION 211 requiring warnings to be 
        prominently displayed in stores;
         AMEND FSMA SECTION 211 to include all retailers, not 
        just major chains;
         SPECIFY THAT WRITTEN WARNINGS must be displayed with 
        the affected product, not just at the cash register;
         EMPOWER the FDA to force a recall if there is a 
        reasonable probability that an article of food is adulterated;
         INCLUDE classes of products that have been identified 
        by the FDA to be injurious to human and/or animal health. If 
        the FDA is issuing advisories, cautions and warnings to 
        customers on their website, then we strongly believe that such 
        information should be broadcast as widely as possible. The 
        Chinese pet treats are a perfect example of such a class of 
        product.

    For myself, and on behalf of Animal Parents against Pet Treats Made 
in China, I want to sincerely thank The Congressional-Executive 
Commission on China for the important work you are doing, and allowing 
us to submit this statement. As a regular consumer, it's easy to get 
discouraged and start to feel hopeless and helpless. Then my spirit is 
renewed to know that we do have great representatives who are just as 
dedicated, and are ceaselessly working behind the scenes on our behalf.

    Terry Safranek, Brooklyn Heights, Ohio
    Tracey Bagatta, Center Moriches, NY
    Robin Pierre, Pine Bush, NY
    Kaly White, Akwesasne NY
    Steve Poponick, Latrobe, PA
    Raymond Parker, Knoxville,TN

                  Questions and Answers for the Record

                              ----------                              

  questions for cvm deputy director, tracey forfa, j.d. from chairman 
                                 brown
    Question. We understand that FDA has plans to increase its U.S. 
staff in China from 8 to 27 staff.
    Is 27 enough to ensure the safety of regulated food and drugs from 
China and if so how did FDA make this determination? Will this lead to 
an increase in food and drug inspections and by how much?
    Answer. The Food and Drug Administration's (FDA or the Agency) plan 
to increase staffing in the China office to 27 represents more than a 
three-fold increase. FDA is optimistic that the increased staffing will 
expand the Agency's capacity to detect and address risks for foods, 
drugs, and ingredients manufactured in China that are exported to the 
United States. It will enhance FDA's ability to ensure that Chinese 
manufacturers, processors, packers, and distributors institute measures 
to assure that foods, drugs, and ingredients imported into the United 
States are safe and meet FDA standards. At full staff, the Agency 
expects the number of food and drug inspections by in-country staff to 
increase by about 200 inspections annually. FDA expects to further 
assess the sufficiency of our capacity once the planned increases in 
staffing are in place.
    Until new staff members are brought in to the FDA China Office, FDA 
will continue to staff the office as well as conduct inspections in 
China through short-term trips made by FDA consumer safety officers 
(CSOs) based in the United States. This is in addition to our ongoing 
measures to ensure the safety of products offered for importation into 
the United States from China and other countries. For example, FDA 
electronically screens all imports using an automated risk-based system 
to determine if shipments meet identified criteria for physical 
examination or other review. FDA developed the Predictive Risk-based 
Evaluation for Dynamic Import Compliance Targeting application, or 
PREDICT, to enhance the Agency's ability to target high-risk products. 
This sophisticated screening system uses information from many 
sources--such as intrinsic product risks, past inspection results, 
intelligence data, and information about such threats as extreme 
weather that could spoil a shipment--to provide the entry reviewer with 
risk scores on every import line. This system allows FDA to focus its 
resources on those imports that are most likely to pose a danger.

    Question. Of the 19 new staff, have all of them received their 
visas and if not, why not?
    Answer. FDA is working to complete the hiring process for new staff 
for the China Office and is actively recruiting and interviewing staff 
to fill vacancies in the inspectorate, food policy, and supervisory 
staff there. The Agency expects to begin submitting several more visa 
applications in FY 2015.
    There are currently two visa applications pending with the Chinese 
Government for staff members who were hired for the FDA China Office in 
FY 2012 and FY 2013. In discussions connected with the December 2013 
visit to Beijing by Vice President Joe Biden, the Chinese Government 
assured FDA that it would begin granting visas for an increased number 
of U.S. food and drug CSOs stationed in China.

    Question. How many of the 19 new staff have already taken up their 
positions in China?
    Answer. As we indicated in our answer to the previous question, FDA 
is working to complete the hiring process for new staff for the China 
Office and is actively recruiting and interviewing staff to fill 
vacancies there.

    Question. Has the FDA faced any delays or other problems in 
obtaining visas for U.S. staff to go to China in 2014? If so, please 
describe the delays or other problems and what steps FDA is taking to 
address the issue?
    Answer. Since October 2012, there have been five visas delayed. 
Three of the FDA staff members who were waiting for visa approval have 
decided to pursue opportunities in other parts of the Agency, so there 
are currently two visas that are pending.
    As we stated in our response to Question 2, in addition to the two 
visas currently pending, FDA expects to begin submitting several more 
visa applications in FY 2015.
 question for cvm deputy director, tracey forfa, j.d. from cochairman 
                                 smith
    Question. Just on the visa delay, how many visas have been delayed 
or denied?
    Answer. Since October 2012, there have been five visas delayed. 
Three of the Food and Drug Administration (FDA or the Agency) staff 
members who were waiting for visa approval have decided to pursue 
opportunities in other parts of the Agency, so there are currently two 
visas that are pending. In the meantime, the FDA has been supplementing 
its China staff with FDA investigators on short-term (60-, 90-, or 120-
day) assignments. Many of the FDA investigators who have done short-
term assignments in China over the last two years are now applying to 
be posted in China for long-term assignments.
    In discussions connected with the December 2013 visit to Beijing by 
Vice President Joe Biden, the Chinese Government assured FDA that it 
would begin granting visas for an increased number of U.S. food and 
drug consumer safety officers (CSOs) stationed in China.
  additional question for the record for cvm deputy director, tracey 
                    forfa, j.d. from chairman brown
    Question. Do you know enough about the larger system to be able to 
say definitively that all of these ingredients [in Happy Hips treats 
which bear the label, ``Made in the USA''] are from the United States?
    Answer. As an initial matter, the product may be subject to 
labeling requirements imposed by the Department of Homeland Security's 
Customs & Border Protection (CBP). CBP has responsibility for 
implementing country-of-origin labeling requirements on certain food 
articles, including pet food. CBP requires country-of-origin labeling--
they call it ``marking''--on imported, foreign-origin food articles or 
their containers unless there is a ``substantial transformation'' of 
the food in the United States before it is distributed to the public. 
It is also my understanding that, in general, the origin of individual 
ingredients in a food product is not required to be marked on the food 
product if the ingredient undergoes substantial transformation in the 
manufacture of the food product.
    Even if CBP determines that, due to substantial transformation in 
the U.S., an imported ingredient in a food product does not need a 
foreign country-of-origin mark, it still might not be permissible to 
label the food product as ``Made in the USA'' if it has foreign 
ingredients. Under the Federal Food, Drug, and Cosmetic Act, a food is 
misbranded if its labeling is false or misleading. The Food and Drug 
Administration (FDA) would make such a determination regarding a ``Made 
in the USA'' statement on a label on a case-by-case basis, consulting 
as appropriate with CBP and the Federal Trade Commission, which 
regulates ``Made in the USA'' claims in advertising.
    FDA food labeling regulations also require that the label of a 
packaged food, including pet food, bear the name and place of business 
of the manufacturer, packer, or distributor. The statement of place of 
business must contain the street address (unless the firm's name and 
address are listed in a current city directory or telephone book); city 
or town; state (or country, if outside the United States); and zip code 
(or mailing code used in countries other than the United States). While 
there is no requirement that the label specifically identify the name 
and address of the food manufacturer, if the firm identified on the 
label is not the manufacturer of the food, the firm name must be 
accompanied by a qualifying phrase that states the firm's relationship 
to the product, e.g., ``manufactured for'' or ``distributed by.'' If an 
individual has questions about the country of origin of a particular 
product or its ingredients, that person may contact the company on the 
label to request information.

                                 [all]