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88–496 PDF 2015

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 

Printed for the use of the Congressional-Executive Commission on China 

( 

Available via the World Wide Web: http://www.cecc.gov 

CONGRESSIONAL-EXECUTIVE COMMISSION ON CHINA 

LEGISLATIVE BRANCH COMMISSIONERS 

Senate House 

SHERROD BROWN, Ohio, Chairman 

CARL LEVIN, Michigan 

DIANNE FEINSTEIN, California 

JEFF MERKLEY, Oregon 

CHRIS SMITH, New Jersey, Cochairman 

FRANK WOLF, Virginia 

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) 

(III) 

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 

(1) 

PET TREATS AND PROCESSED CHICKEN FROM 

CHINA: CONCERNS FOR AMERICAN 

CONSUMERS AND PETS 

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. 

2 

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 ChairVerDate Mar 15 2010 09:40 Feb 04, 2015 Jkt 000000 PO 00000 Frm 00006 Fmt 6633 Sfmt 6633 U:\DOCS\88496.TXT DEIDRE
3 

man 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 comVerDate Mar 15 2010 09:40 Feb 04, 2015 Jkt 000000 PO 00000 Frm 00007 Fmt 6633 Sfmt 6633 U:\DOCS\88496.TXT DEIDRE
4 

plex 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. 

5 

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 

6 

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 onsite 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 illVerDate Mar 15 2010 09:40 Feb 04, 2015 Jkt 000000 PO 00000 Frm 00010 Fmt 6633 Sfmt 6633 U:\DOCS\88496.TXT DEIDRE
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ness. 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 veteriVerDate Mar 15 2010 09:40 Feb 04, 2015 Jkt 000000 PO 00000 Frm 00011 Fmt 6633 Sfmt 6633 U:\DOCS\88496.TXT DEIDRE
8 

narians 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 

9 

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 

10 

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 manufacVerDate Mar 15 2010 09:40 Feb 04, 2015 Jkt 000000 PO 00000 Frm 00014 Fmt 6633 Sfmt 6633 U:\DOCS\88496.TXT DEIDRE
11 

turer 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. 

12 

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 

13 

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. 

14 

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-andpop 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 

15 

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 

16 

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. 

17 

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. 

18 

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 apVerDate Mar 15 2010 09:40 Feb 04, 2015 Jkt 000000 PO 00000 Frm 00022 Fmt 6633 Sfmt 6633 U:\DOCS\88496.TXT DEIDRE
19 

proved 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 

20 

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. 

21 

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.] 

22 

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. 

23 

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. 

24 

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 

25 

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. 

26 

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 

27 

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 deVerDate Mar 15 2010 09:40 Feb 04, 2015 Jkt 000000 PO 00000 Frm 00031 Fmt 6633 Sfmt 6633 U:\DOCS\88496.TXT DEIDRE
28 

pends 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, poVerDate Mar 15 2010 09:40 Feb 04, 2015 Jkt 000000 PO 00000 Frm 00032 Fmt 6633 Sfmt 6633 U:\DOCS\88496.TXT DEIDRE
29 

tentially 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 

30 

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 

31 

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. 

32 

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 

33 

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 

34 

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. 

35 

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. 

36 

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. 

37 

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 

38 

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.] 

(39) 

A P P E N D I X 

40 

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-ofentry 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 

41 

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. 

42 

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 

43 

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 imVerDate Mar 15 2010 09:40 Feb 04, 2015 Jkt 000000 PO 00000 Frm 00047 Fmt 6601 Sfmt 6621 U:\DOCS\88496.TXT DEIDRE
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prove 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 investigaVerDate Mar 15 2010 09:40 Feb 04, 2015 Jkt 000000 PO 00000 Frm 00048 Fmt 6601 Sfmt 6621 U:\DOCS\88496.TXT DEIDRE
45 

tion, 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 

46 

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 

47 

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 readyto-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 readyto-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 multistate 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 

48 

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 

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stakeholders, from industry to authorities to the research community, the encouraging thing is we can. 


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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). 


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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 AgriVerDate Mar 15 2010 09:40 Feb 04, 2015 Jkt 000000 PO 00000 Frm 00066 Fmt 6601 Sfmt 6621 U:\DOCS\88496.TXT DEIDRE
63 

culture 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. 

64 

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. 

65 

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 alVerDate Mar 15 2010 09:40 Feb 04, 2015 Jkt 000000 PO 00000 Frm 00069 Fmt 6601 Sfmt 6621 U:\DOCS\88496.TXT DEIDRE
66 

ways 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. 

67 

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 thouVerDate Mar 15 2010 09:40 Feb 04, 2015 Jkt 000000 PO 00000 Frm 00071 Fmt 6601 Sfmt 6621 U:\DOCS\88496.TXT DEIDRE
68 

sands, 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 

69 

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 

70 

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? 

71 

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. 

Æ