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




                               before the



                             FIRST SESSION


                              MAY 22, 2013


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Senate                               House

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


                  SETH D. HARRIS, Department of Labor
              FRANCISCO J. SANCHEZ, Department of Commerce
     NISHA DESAI BISWAL, U.S. Agency for International Development

                    Lawrence T. Liu, Staff Director

                 Paul B. Protic, Deputy Staff Director


                             CO N T E N T S



Brown, Hon. Sherrod, a U.S. Senator from Ohio; Chairman, 
  Congressional-Executive Commission on China....................     1
Schuchat, M.D., [RADM, USPHS], Anne, Assistant Surgeon General, 
  U.S. Public Health Service; Acting Director, Center for Global 
  Health, Centers for Disease Control and Prevention [CDC].......     3
Solomon, D.V.M., M.P.H., Steven M., Associate Director for Global 
  Operations and Policy, Office of Global Regulatory Operations 
  and Policy, U.S. Food and Drug Administration..................     4
Turner, Jennifer, Director, China Environment Forum, Woodrow 
  Wilson Center..................................................    13
Huang, Yanzhong, Senior Fellow for Global Health, Council on 
  Foreign Relations; Associate Professor and Director, Center for 
  Global Health Studies, Seton Hall University...................    15
Corbo, Tony, Senior Lobbyist, the Food Program, Food & Water 
  Watch..........................................................    17

                          Prepared Statements

Schuchat, M.D., [RADM, USPHS], Anne..............................    26
Solomon, D.V.M., M.P.H., Steven M................................    29
Turner, Jennifer.................................................    33
Huang, Yanzhong..................................................    38
Corbo, Tony......................................................    40

Brown, Hon. Sherrod..............................................    52
Prepared Statement of Hon. Christopher Smith, a U.S. 
  Representative from New Jersey; Cochairman, Congressional-
  Executive Commission on China..................................    53

                       Submission for the Record

Written Statement Submitted for the Record by Elizabeth Economy, 
  C.V. Starr Senior Fellow and Director for Asia Studies, Council 
  on Foreign Relations...........................................    55



                        WEDNESDAY, MAY 22, 2013

                                       Commission on China,
                                                    Washington, DC.
    The hearing was convened, pursuant to notice, at 10:20 
a.m., in room 562, Dirksen Senate Office Building, Senator 
Sherrod Brown, Chairman, presiding.


    Chairman Brown. The Congressional-Executive Commission on 
China will come to order.
    Thank you for attending this timely hearing. I look forward 
to hearing the distinguished panelists, whom I will introduce 
in a moment, for being here to raise awareness about this 
important public health topic.
    There are three new Members of the House of Representatives 
that have been appointed to the Commission: Congressman Frank 
Wolf, a long-time Virginia Republican; also Congressman Robert 
Pittenger and Congressman Mark Meadows will be joining. I hope 
the remaining appointments from both parties in both Houses 
will be made soon.
    In recent months, the world has once again been reminded 
just how closely our health and safety is tied to the People's 
Republic of China. The current bird flu outbreak has claimed 36 
lives and has spread to Taiwan. The discovery of 20,000 dead 
pigs floating in Shanghai and rat meat being passed off as lamb 
have renewed concerns about the safety of China's food exports.
    Pollution in Beijing and other cities' industrial areas in 
China especially have reached what most would consider 
intolerable levels. This spring marks the height of the SARS 
crisis of a decade ago which took 774 lives and touched nearly 
every corner of the globe.
    The risk to Americans has increased since we expanded trade 
relations with China without both providing for mechanisms to 
ensure safe imports and without assigning responsibility where 
it belongs in many cases, and without properly equipping our 
safety agencies with tools to ensure safe food.
    In 2001 when China entered the World Trade Organization 
[WTO], the total amount of Chinese goods exported to the United 
States was slightly in excess of $100 billion. A decade-plus 
later, that number has reached a staggering $426 billion, much 
of that food and pharmaceutical components.
    From 2001 to 2012, China's food exports to the United 
States reportedly tripled. Between 2003 and 2011, the volume of 
pet food exports from China to the United States grew 85-fold.
    Americans might be surprised today to learn just how much 
of their food, drugs, and pet food are made in China. Some 80 
percent of our tilapia, 50 percent of our apple juice, and 30 
percent of our garlic come from the People's Republic of China.
    This increased reliance on China has had grave 
consequences. We know six years ago 149 Americans died after 
taking heparin, a widely used blood thinner linked to 
contaminants from Chinese workshops. Thousands of U.S. pets 
have died as a result of tainted treats from China.
    Part of the problem is that some of our companies are all 
too willing to take advantage of China's lax safety standards, 
creating a playing field not level for our homegrown producers, 
putting our public health at risk without the responsibility 
that these corporations should take.
    Just as important has been China's failure to provide its 
citizens basic rights. Chinese citizens lack the political 
freedom to elect officials responsive to their concerns. There 
is no free press to help bring these problems to public light. 
There are no independent courts to ensure officials and 
companies follow the law. And there is no free civil society to 
sustain long-term advocacy on consumer's or public health's 
behalf. The costs of the current Chinese system are clear, both 
to the Chinese people and to consumers who buy products made, 
manufactured, and/or grown in China.
    Without meaningful and effective pressure from their own 
citizens, Chinese officials still too often choose secrecy over 
openness and accountability. Congress must also give close 
examination to our government agencies responsible for safe 
drugs and food and products and to the rules of international 
trade agreements to ensure we do not lower standards.
    It is in some sense a perfect storm. It is the Chinese 
Government and society unwilling or unable to deal with these 
problems. It is U.S. regulatory agencies--understaffed and 
over-worked in many cases--that simply cannot reach into a 
country of 1.3 billion people and do what they need to do. And 
it's American corporations willing to profit but not willing to 
take full responsibility, or in some cases even partial 
responsibility, for what they are bringing into this country.
    I look forward to the testimony of our witnesses. 
Cochairman Smith will be here we think in a few minutes, but 
obviously we will get started. I will introduce the two 
    Dr. Anne Schuchat is an Assistant Surgeon General of the 
U.S. Public Health Service, and Director of CDC's National 
Center for Immunization and Respiratory Diseases. She has 
extensive experience with China. She worked there on the SARS 
emergency response, where she headed a team at the World Health 
Organization's [WHO] China Office. She served as a visiting 
professor for the Beijing Centers for Disease Prevention and 
Control. She has made important contributions to prevention of 
infectious disease in children and has authored and co-authored 
more than 180 articles, book chapters, and reviews. Welcome, 
Dr. Schuchat.
    Dr. Steve Solomon is Associate Director for Global 
Operations and Policy in the Office of Global Regulatory 
Operations and Policy, and Acting Deputy Associate Commissioner 
for Regulatory Affairs for the U.S. Food and Drug 
Administration [FDA]. He has worked at the FDA for more than 
two decades in various capacities, including in the Center for 
Veterinary Medicine as a veterinary medical reviewer, and 
within the Office of Regulatory Affairs.
    Dr. Schuchat, if you would go first and keep your comments 
to more or less five minutes. Thanks.

                        PREVENTION [CDC]

    Dr. Schuchat. Thank you, Senator Brown. I am really pleased 
to be able to update on how CDC's collaborations in China are 
protecting the health of Americans while protecting the health 
of China's own citizens.
    CDC and China have been collaborating for about 30 years on 
public health priorities of global importance. We focused that 
collaboration on technical assistance and capacity building and 
we work with local, State, provincial, and national public 
health institutes.
    A sign of the strength of our collaboration is that the 
Chinese have designated these public health institutes CDCs. 
The phrase ``CDC'' has no meaning in Chinese, but it is their 
attempt to model their program after what we do here in the 
United States.
    Some of our signature programs in collaboration with the 
Chinese include the Global Disease Detection Center [GDD] and 
the Field Epidemiology Training Programs [FETP]. These efforts 
are aimed at training staff to become strong epidemiologists 
and on carrying out priority infectious disease and emergent 
threat investigations.
    The GDD and FETP sites have trained many individuals, 
including 100 of China's top epidemiologists. They have, 
together, investigated over 500 outbreaks to try to rapidly 
assess situations and bring disease under control.
    Another milestone in the collaborations between the CDC and 
China is the influenza work that we have done together since 
the late 1980s. A milestone was accomplished in October 2010 
when the Chinese National Influenza Center became the fifth 
World Health Organization international reference center for 
influenza. China is the only one of those five international 
reference centers that occurs in a lower/middle income country 
and is really providing huge information and collaboration to 
the rest of the world.
    As you mentioned, 10 years ago I was in Beijing during the 
SARS epidemic there and I have personally seen a huge change in 
the capacity and transparency of my counterparts in China. This 
is most evident in their response to the H7N9 influenza threat 
that is ongoing.
    As you mentioned, since March this new strain of influenza 
has been identified in China. They rapidly reported the full 
genetic sequence of this new influenza strain and took 
intensive efforts to understand the problem and try to bring it 
under control.
    There have been 131 cases reported so far. The last several 
weeks we haven't seen new cases, primarily we believe related 
to their closing down live bird markets, although some of the 
improvements may be due to seasonality of these viruses. We are 
not at all out of the woods with that particular strain, but we 
think the transparency and collaboration was very good for 
their response.
    Another sign of their improved capacity is their expansion 
of their influenza work. They have increased from some 90 
clinical sites looking for influenza-like illness to over 500. 
They have increased from 60-some labs that could characterize 
influenza to over 400 labs all around the country, and the 
sophistication of their work in influenza is much greater.
    We think the investments that the U.S. Government has been 
making in China through the CDC have been catalytic. With about 
a $10 million budget that we provide, they are putting over $10 
billion into their public health system. We strongly believe 
this is helping Americans.
    In some ways China has become a model for other emerging 
economies in developing countries, as we see that over 80 
percent of countries around the world have not yet met their 
requirements for the international health regulations that were 
beefed up after the SARS epidemic so that all countries would 
be more transparent and more able to rapidly respond to health 
threats and communicate them elsewhere.
    We think China has made great strides in improving their 
public health systems and they have become increasingly 
collaborative with the U.S. CDC and other countries.
    We are very grateful for the support that we have been 
getting to strengthen global disease detection around the 
world, including in China, to help keep Americans healthy and 
safe and we think that the world is continuing to be 
challenging. Microbes are constantly changing. We need to 
continue these investments to stay ahead of them.
    Thank you.
    Chairman Brown. Thank you very much, Dr. Schuchat.
    Dr. Solomon?
    [The prepared statement of Dr. Schuchat appears in the 


    Dr. Solomon. Good morning, Chairman Brown. I am Dr. Steve 
Solomon, Associate Director for Global Operations and Policy at 
the Food and Drug Administration [FDA]. Thank you for the 
opportunity to be here today to discuss FDA's efforts to help 
ensure global product safety and quality, and our work related 
to China.
    Sweeping economic and technological changes have 
revolutionized international trade over the last several 
decades, creating a truly global marketplace. Food and medical 
products and their ingredients and components are increasingly 
sourced from abroad. The number of FDA-regulated import 
shipments has more than tripled compared to a decade ago to 28 
million entry lines in fiscal year 2012.
    Americans benefit greatly from this global sourcing of 
products. For example, U.S. consumers have access to a wide 
variety of fruits and vegetables year round, regardless of the 
domestic growing season, as well as access to drugs and 
    At the same time, this rapid globalization of commerce 
poses challenges. Some products entering the United States are 
made or grown in countries that lack the necessary regulatory 
oversight to ensure their safety.
    Greater numbers of suppliers, more complex products, and 
intricate, multi-national supply chains can introduce safety 
risks. Public health challenges associated with globalization 
have manifested themselves in products or ingredients from 
    As you mentioned, Chinese suppliers of heparin substituted 
a lower cost adulterated raw ingredient in their shipments to 
U.S. drug makers, causing severe allergic reactions and deaths. 
In another instance, melamine was added to vegetable protein in 
China and then used as an ingredient in pet foods made in the 
United States, which sickened and killed dogs and cats in the 
United States.
    FDA recognizes that enhanced protection of the American 
public depends increasingly on our ability to reach beyond U.S. 
borders and to engage with other government regulatory 
counterparts as well as with industry and international 
    To address the challenges, FDA is utilizing a variety of 
engagement strategies. For example, FDA's international offices 
help to build strong partnerships with our foreign counterparts 
by providing enhanced opportunity for cooperation and capacity 
building. We now have a permanent FDA presence in 12 foreign 
posts in 9 countries, including China.
    The agency electronically screens all imports using an 
automated risk-based system to determine if shipments meet 
identified criteria for physical examination, analytical 
testing, or other review. This system allows FDA to focus its 
resources on those imports that are most likely to pose a 
danger while at the same time facilitating entry of lower risk 
    FDA recognizes the need to engage in effective regulatory 
cooperation with our global partners. FDA is working 
strategically with a range of countries, including China, to 
provide information and training to strengthen the regulatory 
capacity of our trading partners. In addition to these 
activities, FDA is implementing significant new authorities 
provided by Congress that will help ensure the safety of 
imported products.
    The FDA Food Safety Modernization Act enhances our ability 
to focus on preventing rather than reacting to food safety 
problems. It provides modernized tools to enhance the safety of 
both domestic and foreign food. For example, importers will 
have explicit responsibility to verify that their foreign 
suppliers have adequate preventive controls in place to ensure 
that the food they produce is safe.
    Last year, Congress granted FDA other important new 
authorities with the passage of the Food and Drug 
Administration Safety and Innovation Act, which focuses on 
improving the safety and integrity of the drug supply chain. 
FDA is working hard to implement these new laws.
    Let me turn to some specifics on China. As the number of 
products imported from China has increased, so have the 
challenges. FDA is taking several actions in response to these 
challenges. FDA currently has 13 officers posted in 3 locations 
in China: Beijing, Shanghai, and Guangzhou.
    The mission of FDA's China Office is to strengthen, 
monitor, and help safeguard the safety, quality, and 
effectiveness of FDA-regulated products produced in China for 
export to the United States. FDA's China Office works to 
fulfill this mission through collaborating and capacity 
building with Chinese regulatory counterparts, academia, and 
non-governmental partners; reaching out to regulated Chinese 
firms to enhance compliance with FDA's standards; and 
conducting inspections of facilities that manufacture FDA-
regulated goods.
    To protect American consumers from potentially unsafe 
imported products, we utilize various regulatory controls. For 
example, when FDA finds a problem with a product, producer, or 
importer, FDA issues an import alert. There are currently 74 
active FDA import alerts that include firms based in China. 
Under these import alerts, producers' products may be detained 
at the border and may be refused admission into U.S. commerce 
unless the importer is able to demonstrate that the products 
are in compliance with all FDA laws and regulations.
    There are currently nine country-wide import alerts for 
China, including one for milk products and another for 
vegetable protein from China because of the presence of 
    While regulated industry has the primary responsibility to 
produce safe products, it is important that governments provide 
meaningful and robust regulatory oversight. FDA is working with 
China to help them improve their regulatory systems and to 
educate them on the new standards being implemented by FDA.
    On both fronts, here in the United States and in China, FDA 
is pursuing a comprehensive strategy to enhance the safety and 
quality of imported products and establish an effective global 
product safety net.
    I am happy to answer any questions you may have.
    [The prepared statement of Dr. Solomon appears in the 
    Chairman Brown. Thank you, Dr. Solomon.
    Dr. Schuchat, let's start with you. You used terms like 
``sophistication is greatly improved,'' ``China's public health 
system is becoming a model for others''--understanding the 
limits of that--and that they ``answer health threats much 
better.'' Is that primarily applied to those dealing with 
infectious disease outbreaks, like avian flu.
    Would you apply that to the issue of manufacturing, 
production, and growing in the pharmaceutical supply chain or 
the supply chain for pet food or any of those other issues, 
that they have greatly improved?
    Dr. Schuchat. Thank you for that question because I did not 
mean to imply the industrial changes or the supply chain 
issues. I am really speaking of their ability to rapidly 
detect, investigate, and respond to primarily infectious 
disease threats, but other unknown issues.
    They did a very nice job recently looking at a problem with 
sudden unexplained deaths that had been occurring in one part 
of the country in Yunnan, and they were able to characterize 
the threat and figured out that it was related to consumption 
of a new species of mushroom. So that was not an infectious 
disease, but a toxic problem, but this is really the 
investigatory response capacity.
    They have also put a lot of resources into improving the 
sophistication of their laboratory detection so they can do 
these sophisticated whole genome sequences. It was really 
impressive how they sequenced the new influenza strains and 
posted them immediately, which permitted the global community, 
the scientific community, to develop new diagnostic tests so 
that others could figure out whether they had the same 
influenza strain, and also to help get us a jump on the 
candidate vaccine/virus development so that if we would ever 
need a vaccine for this particular influenza strain we were 
further along.
    Chairman Brown. It is very different from a decade ago when 
you were there.
    Dr. Schuchat. Incredibly different. Incredibly different.
    Chairman Brown. The habit of authoritarian governments is, 
at least from my experience all over the world, denial of a 
problem first and then deflection of criticism, this did not 
happen here, do not blame us, or whatever. I mean, that is 
maybe human nature, too. What have you seen with transparency 
in China now on disease outbreaks like this?
    Dr. Schuchat. Yes. Sure. Yes. I think that the Chinese 
really suffered during SARS. There was global humiliation, 
there was loss of life, there were huge economic losses. I do 
think that they tried to learn from that in terms of 
aggressively investing in their public health capacity.
    They have become more transparent in dealing with these 
outbreaks and communicating about them. One of the things we 
have done with the U.S. CDC collaboration is help with training 
on risk communication. The culture of ``don't talk about what 
is going on until everything is finished,'' it takes a long 
time to break that kind of culture. Risk communication is a 
technique we use in emergency response to tell people as much 
as we know as soon as we know it and try to sustain credibility 
rather than covering up.
    This is important in public health and something that we 
are helping them get better at. There is still work to do 
there, but I do think that in more recent outbreaks they have 
been much more cooperative. They have invited WHO in, they have 
invited international experts in, to open the books to them and 
really share what is going on. So I would say that they have 
learned from their catastrophe, but like most countries there 
is more work to do.
    Chairman Brown. I remember a decade-plus ago when there was 
an earthquake in Taiwan. The Beijing Government did not give 
World Health authorities permission to go into Taiwan because 
of the peculiar political dynamics of our relations in Western 
and other countries' relationship with the PRC and Taiwan, that 
the Chinese did not give permission for 24 hours or something. 
Has that been an issue with Taiwan here on bird flu?
    Dr. Schuchat. I am not aware of it being an issue. I am not 
    Chairman Brown. The transparency with China has also been 
with Taiwan, that you can see?
    Dr. Schuchat. Yes. I probably do not know enough to answer 
    Chairman Brown. Okay.
    One other question. Talk to me about the central 
government's coordination with local governments on these 
issues, something that has more often than not been a problem.
    Dr. Schuchat. Yes. This is a challenging issue in many 
countries, frankly including our own. But I think the 
strength--the provinces are different. Some are quite strong, 
some do rely more on the central government. I think that it is 
probably a continuum, how well the coordination works. We work 
with all levels. Our primary counterpart is the national level, 
China CDC.
    But I think that there is recognition from some of these 
really horrible outbreaks of how important coordination is and 
how lives depend on it. Here in the United States we exercise--
we use local and State health departments. We work together on 
exercising emergency response and coordination. I think in 
China they have enough multi-provincial outbreaks that show the 
benefit of working together.
    We have been supporting some expansion of their food-borne 
disease surveillance so that they can do what we do here, 
fingerprinting the strains of salmonella and recognizing the 
multi-jurisdictional outbreaks. Those are important health 
issues to identify but they also strengthen the need to work 
across jurisdictions. So we think that with their continuing 
investments in a public health capacity and even this food-
borne disease surveillance expansion, they will get more 
practice working effectively across jurisdictions.
    Chairman Brown. Thank you, Dr. Schuchat.
    Dr. Solomon, contrast the progress of 10 years in Dr. 
Schuchat's comments and what you know about that with the 
progress in 10 years on industrial supply chain, whether it is 
lead-based paint on toys or other contaminants, whether it is 
the pharmaceutical supply chain, whether it is pet food or any 
other kind of food. Contrast the 10 years of progress they have 
made on the infectious disease side with those questions, if 
you would.
    Dr. Solomon. I think the analogy generally works that they 
have been on a trajectory to improve their regulatory systems. 
Clearly, the events of heparin and melamine damaged the product 
name for ``Made in China'' and caused significant new thinking 
among their regulators and some changes in their regulatory 
systems that we continue to see today.
    I think 2007 and 2008 were kind of key years when melamine 
and heparin took place and when we signed agreements on both 
the pharmaceutical side and on the food side with the General 
Administration of Quality Supervision Inspection and 
Quarantine, the AQSIQ, who is responsible for food and feed 
    So our relationship is very different today from when 
melamine took place. We wanted to conduct inspections at that 
point in time. There were issues trying to get into China to 
conduct those investigations, versus now where we have people 
stationed in Beijing that have regular meetings, monthly 
meetings, at the deputy director level.
    Chairman Brown. You said Beijing, Shanghai, Guangzhou. U.S. 
FDA posts. What does that mean in terms of size and resources?
    Dr. Solomon. Correct.
    There are currently 13 folks stationed in China, 8 are U.S. 
citizens, 5 are foreign Chinese nationals.
    Chairman Brown. Among the three or at each of the three?
    Dr. Solomon. Among all three.
    Chairman Brown. Okay. What is their training?
    Dr. Solomon. The folks based in Beijing are mostly policy 
analysts that are working directly with the central government. 
The folks in Guangzhou are food inspectors. The folks in 
Shanghai are drug inspectors. You may be aware that there is 
additional funding in the FY 2013 budget of $10 million where 
we are going to be expanding the number of inspectors, so we 
are adding seven new food inspectors and nine new drug 
inspectors to that list.
    Chairman Brown. The figures that I have been told is we, 
the FDA, inspect 2.3 percent of imported food internationally. 
China's number is higher or lower than that?
    Dr. Solomon. China's number of what we do physical 
inspections on is around double of what we do generally with 
products from around the world.
    Chairman Brown. Around the world. And that is understanding 
USDA's [U.S. Department of Agriculture] jurisdiction is 
different from FDA. That is only FDA?
    Dr. Solomon. That is only FDA products.
    Chairman Brown. So that is--I forget. One does poultry and 
meat, the other does fruits and vegetables.
    Dr. Solomon. USDA regulates poultry and beef.
    Chairman Brown. Poultry and beef. You do fruits and 
vegetables and other processed foods?
    Dr. Solomon. That's correct.
    Chairman Brown. And you do dog treats and pet food?
    Dr. Solomon. We do.
    Chairman Brown. Okay. Whether that is meat-based or not?
    Dr. Solomon. That's correct.
    Chairman Brown. Okay.
    This is an unfair question but I'm going to ask it. Rate 
China's regulators, U.S. regulators as interacting with Chinese 
products that come here, come to the United States, and U.S. 
importers, on a scale of 1 to 10, each of them in two 
categories, 10 years ago and today.
    So on a scale of 1 to 10, how did U.S. regulators do in 
terms of regulating products? It could be toys, could be food, 
could be pharmaceuticals coming from China to the United 
States. How did U.S. regulators--give me a rating there. Give 
me a rating on Chinese regulators and what they did, and 
improvements or not they made. Give me a relative number. Then 
U.S. companies over, say, from 10 years ago and today. That is 
fairly complicated and unfair, but I ask it anyway.
    Dr. Solomon. So let me try and approach it. I think 
everyone is paying more attention and I think a lot of it has 
to do with FDA increasing the standards. So the FDA Food Safety 
Modernization Act is a profound change in food safety laws that 
is going to increase the safety of imported products and puts 
new burdens on importers.
    So there is a foreign supplier verification program, not 
yet implemented but was part of the FDA Food Safety 
Modernization Act, but regulations will be proposed that places 
the burden on the importer to ensure that back in China, or any 
other part of the world, that produce is grown under safe 
conditions and that there is preventive controls at the 
manufacturing facilities.
    Similarly, the FDA Safety and Innovation Act is changing--
    Chairman Brown. Wait. I know, I am going to keep 
interrupting. I apologize. How do you ensure that importers are 
being faithful and truthful--truthful, I guess, more than 
faithful--in verifying the safety of their foreign supplier?
    So how do you ensure that a U.S. company that was bringing 
in toys where there were issues of lead-based paints, or a 
pharmaceutical company that relies on Chinese small companies 
to give them their ingredients, how do you ensure that the U.S. 
importer is being truthful about the Chinese producer?
    Dr. Solomon. So it's a variety of means that take place to 
try and oversee it. So the supply chain, as you have stated, is 
very complex. So we work on improvements with the Chinese 
regulators on their oversight, building capacity with them. We 
conduct inspections of the highest risk facilities. We monitor 
the importers.
    We have a system that has been in place called the PREDICT 
System that uses sophisticated algorithms to look at the 
importers' information and try to verify the veracity. Has this 
importer traditionally only brought in one product and all of a 
sudden they are declaring that the product is a different 
    When the foreign supplier verification program comes into 
place, we will be conducting more inspections of the importers, 
to ensure that they have to have the demonstrated records to 
show that the product produced, foreign or domestic products, 
products from other countries, was based on the preventive 
controls or the produce regulations that apply both 
domestically and to foreign producers.
    So it is a complex myriad of systems. This algorithm in 
PREDICT is why we target more product from certain areas than 
others because it is using risk-based criteria that allows us 
to put our resources to examine products that pose the greatest 
    Chairman Brown. Okay. Thank you.
    If there were a similar kind of problem of deaths from 
heparin in this country, and I do not want to be an alarmist 
but just the size of everything, the size of China, you would 
use the term ``intricate international supply chain,'' so 
something bad will happen here. Some people, pets or somebody 
will be sickened because of something coming from China again. 
I mean, that is no matter how well we do it, I assume. I guess 
you could make that assumption.
    If something comparable and as horrible as heparin happened 
again, something that large, what would be our government's 
response in terms of liability for the importer, in terms of 
what we do with the regulatory apparatus. What would actually 
be the response based on the new law you talked about and based 
on our apparently learning something over the last decade?
    Dr. Solomon. So a direct result of the heparin episode was 
to pass, last July, the FDA Safety and Innovation Act.
    Chairman Brown. Right.
    Dr. Solomon. That additionally puts more burdens on the 
U.S. companies here to make sure that they have quality 
management systems in place that go back to their supply 
    Chairman Brown. And you are seeing that now? You are seeing 
these companies putting better traceability, trace-back on 
their supply chain, even into the smallest Chinese village?
    Dr. Solomon. They are spending more attention on it. They 
are on a trajectory. It has got a long ways to go, but private 
industry is paying more attention back to their supply chain. 
These laws are not in effect yet, but they have clearly seen 
the results from heparin and they have seen the intention of 
Congress and FDA to enact these controls.
    So we are trying to improve the quality of information, 
risk-based approaches to it, and there are new enforcement 
tools that Congress gave us. So if we are not allowed to be 
able to conduct an inspection in China, now those products are 
not allowed into the United States.
    Chairman Brown. Okay.
    If that happens, if the companies are in fact doing due 
diligence and something bad happens, are there liability 
questions? Are there liability issues for those companies? I 
mean, would we see those companies pay a penalty for not doing 
what they were supposed to do, which they should have done with 
heparin, having a traceability, a trace-back mechanism?
    Dr. Solomon. So civil liability, I would leave to others. 
But from an FDA perspective, we have increased penalties. So 
for example, if there is counterfeiting of products, under the 
new FDA Safety and Innovation Act there are now increased 
penalties for counterfeiting of products.
    Chairman Brown. What are those penalties?
    Dr. Solomon. There are new sentencing guidelines that have 
been put in place to allow that sentencing for criminal 
activities of counterfeiting are now more stringent than they 
were before.
    Chairman Brown. Would that be U.S. executives of those 
companies that----
    Dr. Solomon. That would be the responsible party for that 
    Chairman Brown. So if a U.S. toy manufacturer brings in 
products with a high concentration of lead-based paint, it is 
possible executives would go to jail?
    Dr. Solomon. Once again, we need to look at the details of 
specific cases, but there are criminal penalties that are in 
place for counterfeiting or criminal activities.
    Chairman Brown. Okay. You never did give--but I know 
because I kept interrupting you--me numbers. Let me ask that a 
different way, the question--the more obnoxious question I 
asked a minute ago. If Chinese regulators--I will try to do it 
this way.
    If Chinese regulators were a 5 on a scale of 1 to 10, 10 
years ago, what would they be now? If U.S. regulators were a 5 
on a scale of 1 to 10, 10 years ago, what would they be now? If 
U.S. companies, on their corporate responsibility and 
traceability, track-back, were a 5 on a scale of 1 to 10, 10 
years ago, what would each of them be today?
    Dr. Solomon. It is tough to sort of categorize, as I am 
sure you appreciate, kind of each company. They are all on a 
trajectory to try and improve those pieces. FDA is improving 
its relationship. There are issues in relation to the central 
government in China and the relationships to the provincial and 
local governments, not unlike issues in the United States where 
we spend a lot of time investing in and developing an 
integrated national food safety system.
    We spend a lot of efforts trying to work with our State, 
local, regulatory, and public health counterparts, exercising 
our response teams, putting new standards in places. They have 
a long ways to go in trying to build that type of integrated 
system, but the central government is putting new laws into 
place, they are investing more resources, they are better 
understanding our new standards and requirements. There is a 
lot of learning that still needs to take place.
    They spend a lot of time and effort focusing on testing of 
products. We believe the better approach is understanding 
manufacturing processes and controls, the process needs to be 
day-in and day-out controlled, so we are working with them to 
try and enhance their understanding that their laboratories are 
fairly sophisticated and can do a lot of analytical testing. 
But the answer is not just laboratory testing and analytical 
testing of products, but also ensuring that the processes are 
controlled to produce safe products.
    Chairman Brown. Okay.
    I recognize your challenge. I know there is enough anti-
government sentiment in both chambers of this body, and 
sometimes it is certainly unfair, that when you think about the 
challenge of inspecting products in a country of 1.3 billion, 
let alone in a country of 300 million, the challenges there, 
and when we are not willing to devote very many resources 
relative in terms of dollars appropriations to expect so much 
of you.
    Let me pose one question. My wife and I--our children are 
grown--about a year and a half ago bought a dog we named 
Franklin, named after my favorite President, if that tells you 
something about my politics. My daughter said it is finally the 
son we always wanted, but that is a whole other story. Would 
you recommend that we not buy dog food for Franklin made in 
    Dr. Solomon. So I think most dog food is--very little dog 
food is made----
    Chairman Brown. Or pet treats. Let me ask, any of 
Franklin's diet. Would you buy none of it in China?
    Dr. Solomon. So the safety----
    Chairman Brown. Or do you not like dogs. Do you like dogs?
    Dr. Solomon. I do. I am a veterinarian and I am a pet 
    Chairman Brown. That does not mean you like dogs because 
you are a veterinarian. I know some doctors who do not like 
people that much.
    Chairman Brown. I know politicians that don't like people 
that much. Okay. Start again.
    Dr. Solomon. So, pet treats are not a necessary part of a 
dog's diet. It's not part of a necessary, balanced diet that 
they need to have, so I don't feed them to my dog because they 
are an unnecessary part of their diet.
    Chairman Brown. And you didn't let your children have candy 
    Chairman Brown. All right. Thank you both for joining us. 
We will call up the next panel.
    Welcome. I'd like to introduce the three panelists and then 
hear their statements, then we'll go to questions. My 
understanding is Congressman Smith is voting. His arrival is, 
we hope, still imminent.
    Dr. Jennifer Turner is director of the China Environment 
Forum at the Woodrow Wilson Center and a noted expert on 
China's environmental energy issues. Her current projects 
include an initiative uncovering how energy is impacting water 
in China, research and exchanges on U.S.-China energy and 
climate cooperation, and meetings and research examining 
environmental impact of Chinese investment overseas. She is 
also editor of the Wilson Center's journal, the China 
Environment Series. Dr. Turner, welcome.
    Dr. Yanzhong Huang is a Senior Fellow for Global Health at 
the Council on Foreign Relations and Associate Professor and 
Director of the Center for Global Health Studies at the John C. 
Whitehead School of Diplomacy and International Relations at 
Seton Hall. Dr. Huang has written extensively on global health 
and public health in China, and U.S. relations with China. His 
articles and op-eds have appeared in the New York Times and 
Foreign Affairs. He has a new book titled, ``Governing Health 
in Contemporary China.'' Welcome, Dr. Huang.
    Tony Corbo is Senior Lobbyist for the Food Program at Food 
& Water Watch, responsible for food-related legislative and 
regulatory issues that come before the Senate and the House and 
the executive branch. Mr. Corbo has extensive organizing 
experience, having directed major public employee 
representation campaigns in several States. Thank you for doing 
that. My daughter did that for a living for a number of years.
    Dr. Turner?


    Ms. Turner. Thank you for inviting me. I am looking forward 
to those hard questions later on.
    I am sitting in Liz Economy's place, initially, here, but 
she and I agree on a lot of things so I think hopefully you 
will get some of the same or similar stories.
    The Chinese Central Government is not known for its 
transparency. We recall not too long ago--I think you list 
history--in 1994 doing my dissertation work on Chinese water 
policy implementation, the most benign government documents 
were secret. Today, happily in my work at the Wilson Center, 
there is a lot of access. It is very exciting. I get to gather 
lots of data and work with organizations in China focused on 
solutions to energy and environmental problems. So there has 
been a lot of changes over the last 10, 12 years.
    Another big change in the past few years. The Chinese 
public is demanding more openness around pollution issues, a 
big change from when I was first in China. After decades of 
these laws and targets to clean up the environment, the Chinese 
public actually believes they have a right to a clean 
environment. With the Internet, they are starting to have tools 
to actually demand and put voice to these kinds of claims.
    They do not just have to march out onto the street; in 
fact, a lot of these urbanites--and they are the ones who do 
tend to have the voice--are finding that they can be quite 
effective, at least in some more recent cases like the smog 
that was blanketing Beijing which has been going on for several 
    Over these past few years we have seen Chinese netizens who 
started to put pressure and successfully demand that Beijing 
start measuring small particulate pollution and also use 
standards that are closer to the United States. They did not 
really like that their standard said ``fair'' when the U.S. 
standard said ``hazardous, run inside.''
    Another good change that really has also encouraged the 
public to demand information is that in 2008 the Ministry of 
Environmental Protection passed an open environmental 
information measure that said you have a right to ask for this 
information. It is a new tool. It does not always work--not too 
    But then most recently in a case that did not work that has 
made the headlines, and I think that is striking, the Chinese 
news media actually criticized the Ministry of Environmental 
Protection for not disclosing the soil pollution survey. The 
survey probably has lots of not-so-happy information about soil 
quality in China.
    The Ministry of Environmental Protection said, ``Well, no, 
it is a state secret,'' then they changed their mind and said, 
``Well, no, it is incomplete data, we will disclose it when we 
get better.''
    But I actually think one of the real reasons they are not 
quite ready to disclose it is that they do not have the laws 
and regulations to really deal with soil pollution. What are 
the standards? What is the compensation? So if you release this 
information, the public's demand is going to say, ``Well, what 
do we do? '' We do not have the tools yet.
    So it is an example that I talk a little bit more about in 
my written testimony, about how you have these new open 
information--transparency, public right to participate, but 
these mechanisms and tools do not always work when other parts 
of the environmental governance system are incomplete.
    On the good news side, Liz and I both talk about Ma Jun, an 
environmental activist who has used government data to create 
online water and air pollution databases. It has gotten the 
attention of not just the Chinese Government, but international 
and Chinese businesses, sparking a kind of greening of supply 
chains so instead of going to the government and saying you 
need to enforce this, going directly to the companies--often 
that are owned by the government--to actually naming and 
shaming so they do enforce.
    Taking his transparency work even further, Ma Jun has 
started working with the Natural Resources Defense Council in 
2009 to create a Pollution Information Transparency Index. It 
ranked 113 cities on how well they were disclosing information. 
They were not doing it very well, but what's interesting, they 
were able to keep going back and gathering this information, 
doing this index, and it is becoming more of kind of an 
education for the city officials and how the city officials are 
saying, ``Oh, this is a tool that we can use,'' because the 
city officials, they, too, are blanketed with this smog and it 
is affecting their health. So again, kind of institutions in 
    Public interest lawsuits are also a work in progress. In 
2007, we started seeing lawyers and non-governmental 
organizations [NGOs] trying to bring pollution cases in the 
public interest, that they were not injured themselves but 
because the Songhua River was polluted, or more recently 
cadmium tailings were dumped in a rural community in Hunan 
province, highly toxic. What is striking is that in a 2011 case 
two Chinese NGOs, independent NGOs, were actually able to bring 
the case to court because Hunan had provisions that granted 
them the standing.
    Now, as of January this year there is standing for NGOs and 
other organizations that want to bring public interest 
lawsuits, but as you mentioned in your introduction the 
judiciary is not necessarily that independent. Local courts do 
not maybe want to take this giant pollution case if it is a 
company that is giving a lot of tax to the local government.
    China has created another institution-in-waiting, these 
environmental law courts. There are about 90 of them. They have 
not been taking that many hard-hitting cases yet so there is 
some speculation, now that there are actually rules on the book 
that NGOs have standing, that maybe these environmental courts 
could really start turning into something more effective.
    I will wrap up. There are lots of NGOs, research 
organizations, and the U.S. EPA [Environmental Protection 
Agency] working with China on some of these open information 
and transparency laws and regulations, trying to help to build 
the capacity. And I think because the Chinese Government is 
seeing--well, because they cannot see because of the smog--that 
the pollution problems are costing the economy. A lot of people 
in my network are seeing that there is more opening to working 
with China on these issues.
    So I am going to halt there, and I am looking forward to 
your questions.
    Chairman Brown. Thank you, Doctor.
    Dr. Huang, welcome.
    [The prepared statement of Ms. Turner appears in the 


    Mr. Huang. Thank you, Senator Brown, for inviting me, I am 
honored to be here again. Ten years ago, I testified in the 
same place on China's SARS crisis, so I am glad to be back.
    Today I am going to talk about China's public health 
hazards, especially in regard to its handling of public health 
emergencies of international concern, such as the H7N9 
outbreak. Dr. Schuchat has already spoken about how China is 
becoming more transparent and also more collaborative in 
sharing disease-related information and risk communication, so 
I am not going to repeat what she said.
    I think it would be useful for us to ask the following 
question: Is China's move toward greater transparency in 
disease-related information sharing and risk communication 
    I have a very mixed answer to that question. On one hand, 
the government has built up its capacity in responding to 
disease outbreaks. It is overall compliant with the 
International Health Regulations, the international law that 
requires governments to report public health emergencies of 
international concern in a timely and accurate manner.
    On the other hand, I also found that the central-local gap 
in epidemiology and laboratory capacities, that is, their 
capacity to correctly and swiftly identify emerging infections, 
could be a major challenge--especially when the gap is coupled 
with an authoritarian political structure. The gap could 
contribute to sustained coverups, under-reporting or even 
misreporting at the sub-national level, as we saw in 2009 
during the H1N1 pandemic.
    Also, when health is increasingly viewed as a high politics 
issue on the government agenda, the response to public health 
emergencies can potentially be hijacked by domestic political 
considerations. This we also saw in 2009 during the H1N1 
pandemic. H1N1 happened at a time when China was about to 
celebrate the 60th anniversary of the founding of the People's 
Republic of China. The government did not want to ruin the 
party, and the socio-political stability became such a dominant 
concern for the government leaders and that contributed to the 
lingering coverup of the fatality cases of H1N1. So if you look 
at the H7N9 outbreak, one of the reasons behind greater 
transparency was that there were not that many significant 
political events overlapping at the same time as the outbreak.
    Also, I think it is worth pointing out that China still 
does not have robust civil society organizations participating 
in the process of disease reporting, even though the 
International Health Regulations, revised in 2005, 
legitimatized the non-governmental actors' role in disease 
surveillance. Indeed, the number and size of health-related 
NGOs in China remain very small and a vast majority of them are 
heavily dependent upon international donors for support. Few 
NGOs, if any, work on public health emergencies, and most of 
them are focused on one area: HIV/AIDS prevention and control.
    So in that sense I am not that optimistic about improved 
transparency and open communication in future outbreaks. In 
fact, if you look at the H7N9 outbreak, what worries me is not 
whether China is going to be more transparent or not. What 
worries me is the prospect of overreaction to a disease 
    As I previously mentioned, when health becomes a high 
politics issue and the government attaches so much importance 
on the disease outbreak, it could lead to a bandwagon effect at 
the local level in policy implementation. The local leaders 
will try to become ``more Catholic than the Pope,'' so to 
speak, which could trigger the dynamics that lead to government 
overreaction, potentially compromising individual privacy and 
human rights in China. We actually saw this happen in 2009; for 
example, the father of the second confirmed H1N1 case had to 
publicly apologize for his son being sick on government TV.
    Chairman Brown. Thank you, Dr. Huang.
    Mr. Corbo?
    [The prepared statement of Mr. Huang appears in the 

                       FOOD & WATER WATCH

    Mr. Corbo. Senator Brown, my name is Tony Corbo and I am 
the senior lobbyist for the Food Program at the not-for-profit 
consumer advocacy organization, Food & Water Watch. We were 
founded in November 2005. Prior to that, we were part of Public 
Citizen and one of your staffers had to deal with my rants down 
the hall on a continual basis because we were neighbors.
    We currently represent some 500,000 members and supporters 
on a variety of issues affecting the food and seafood we eat 
and the water we drink. We commend you and your leadership for 
holding this hearing, and thank you for inviting us to share 
our views.
    Food & Water Watch has been interested in the issue of 
Chinese food safety just about from our organization's 
inception because it was on November 23, 2005, that USDA's Food 
Safety and Inspection Service [FSIS] proposed a regulation that 
would list the People's Republic of China as a country eligible 
to export poultry products to the United States.
    To be able to do that, FSIS would have had to have found 
China to have an equivalent food safety system to that of the 
United States. In reviewing the audits conducted by FSIS 
personnel, we were perplexed why FSIS was moving forward. Some 
of the poultry plants they visited had serious sanitation 
issues, and in many of the plants there were no government 
inspectors present. The poultry was being inspected and passed 
for its safety by company-paid employees.
    What also seemed problematic to us was the fact that China 
was ground zero for several outbreaks of highly pathogenic H5N1 
avian influenza that affected hundreds of thousands of birds in 
China, and it also killed a number of Chinese citizens. The 
Chinese Government had kept secret some of the early outbreaks 
of this animal disease.
    Most of the comments that FSIS received on the proposed 
rule were in opposition, including comments filed by Food & 
Water Watch. Ironically, the only comments that were filed in 
support of the proposed rule came from Chinese entrepreneurs 
who proclaimed the safety of their poultry.
    In April 2006, FSIS finalized the rule but placed some 
restrictions on what could be exported to the United States. 
China was not authorized to slaughter its own poultry to export 
to the United States, instead the poultry it exported to the 
United States had to be cooked and raw poultry had to originate 
from approved sources.
    At the time of the rule, the only approved sources were the 
United States and Canada. So North American poultry slaughter 
facilities could send raw product to China for cooking so that 
it could be exported back to the United States.
    We discovered through documents we received through a 
Freedom of Information Act request that the Animal and Plant 
Health Inspection Service [APHIS] at USDA was very concerned 
about the lack of transparency displayed by the Chinese 
Government of the avian influenza outbreaks in that country, so 
APHIS wanted to ensure that we were not importing poultry meat 
from sick birds.
    China never certified any of its plants to export under the 
April 2006 rule because they were interested in exporting their 
own poultry products to the United States. Congress eventually 
took action and prohibited FSIS from moving forward with 
implementing any regulation that would permit the importation 
of poultry products from China.
    China eventually filed a WTO--World Trade Organization--
complaint that was eventually sustained, but even before the 
final WTO ruling was published the congressional ban was lifted 
in 2010. China was very slow to invite FSIS back to renew the 
audit process. The most recent audit took place in March of 
this year. We still have not imported any poultry meat for 
human consumption.
    In the meantime, the number of Chinese food exports that 
fall under the jurisdiction of the Food and Drug Administration 
has skyrocketed, to the point where 80 percent of the tilapia 
we are consuming in the United States is imported from China, 
nearly two-thirds of the apple juice we consume in the United 
States is imported from China, over half of the codfish we 
consume in the United States is imported from China, and about 
a third of the mushrooms we consume, yes, is also imported from 
    Unlike FSIS, the FDA does not have the same regulatory 
apparatus to recognize exporting countries' food safety systems 
before they can export. While the Congress passed, and 
President Obama signed into law, the Food Safety Modernization 
Act that contains provisions that enhance FDA's ability to 
regulate the safety of imported food, that law has not been 
fully implemented.
    So our primary line of defense at FDA for food imports, for 
food products imported under its jurisdiction, is port of entry 
inspection. In good years, FDA conducts inspections of about 2 
percent of imported food products.
    Now, I want to get back to the chicken issue to expose some 
holes in our regulatory system. While poultry for human 
consumption is regulated by USDA, if those poultry products, as 
you have already pointed out, are turned into pet food they 
fall under FDA's jurisdiction. While China has been waiting for 
a green light to export their poultry to the United States for 
human consumption, it discovered that it could still export 
poultry meat to the United States if it were turned into pet 
    Over the past decade, the volume of imported pet food from 
China has increased 85-fold. In 2007, FDA started to receive 
reports from dog owners that their pets were getting sick from 
consuming chicken jerky treats imported from China.
    The FDA has issued several warnings to pet owners, urging 
them not to feed their dogs Chinese jerky treats. As pets 
actually died and more got sick from eating these products, 
several Members of Congress, including you, Senator Brown, 
called on the FDA to conduct physical inspections of the 
Chinese pet food manufacturing facilities.
    In March and April 2012, FDA conducted inspections of those 
facilities in China. When FDA inspectors asked that they be 
able to take samples of those products for analysis in FDA 
labs, the Chinese Government refused.
    FDA was able to stop the importation of pet treats from one 
of those plants it visited because of falsification of records. 
That plant claimed that it had been importing industrial grade 
glycerin from Malaysia to make its pet treats instead of food 
grade glycerin. We suspect that the Chinese pet food 
manufacturer did that to avoid paying higher tariffs.
    When FDA inspectors visited that Malaysian ingredients 
manufacturer in August 2012, they were able to take samples of 
the plant's products so that they could be tested in FDA labs. 
FDA was eventually able to confirm that food grade glycerin was 
actually being used in those pet treats.
    To this day, we still do not know why these pets are dying 
and getting ill from imported pet treats from China. Certain 
products have been recalled because the New York State 
Department of Agricultural Markets found that some of the pet 
treats imported from China contained residues of antibiotics 
that were not approved here in the United States.
    There have been numerous food safety scandals in China. The 
melamine situation and the infant formula is the most 
notorious. China, as has already been pointed out, does not 
have a free and independent consumer movement that can 
challenge the government's actions, or inaction, on food safety 
issues. As the volume of imports continues to increase in this 
country, we really do need to give our regulatory agencies the 
tools and the resources to ensure that these products are safe 
for Americans to eat.
    Thank you very much.
    [The prepared statement of Mr. Corbo appears in the 
    Chairman Brown. Thank you, Mr. Corbo. Thank you very much 
for your testimony, all three of you.
    Dr. Turner, if we conclude that things are improving in the 
regulatory, environmental, and public health, with many 
exceptions but are generally going the right way, do you find 
that--you talked about state-owned enterprises in one sentence 
in your testimony--do you find that their behavior is better or 
worse than private companies in China than the whole? Can you 
make a judgment like that?
    Ms. Turner. No, I think that is very difficult.
    Chairman Brown. Where do you see the improvements in 
production, in manufacturing, and among companies? Where are 
the improvements and where are they least likely to improve, or 
is there least evidence of improvement?
    Ms. Turner. Well, I mean, it is a work in progress. I mean, 
we do have cases where either the environmental watchdogs call 
out a company that is polluting or the citizens themselves go 
to the streets. Also, cases you probably heard were actually--
the people don't actually--when I was in Zhejiang province, 
actually the farmers went and ripped the factory apart with 
their own hands. So, that factory was closed.
    But the challenge is that sometimes when there are 
protests, cities--urbanites used the open information to 
condemn a factory that is polluting, it is NIMBY [not in my 
backyard], and then these factories pack up and they move 
further inland, where the economies are not as rich and the 
likelihood of protest maybe is less, or sometimes the protest 
cycle starts again.
    It is really hard to say. When I talk about Ma Jun and some 
of these other NGOs that Liz and I mentioned, they are still 
not huge in number but they have been trying to work to use the 
Internet to kind of highlight these kinds of problems within 
the industry and we are starting to see some other NGOs 
developing in the provinces to try to follow Ma Jun's example 
of using open information, creating networks of volunteers to 
put pressure on companies and working with local governments.
    So I mean right now I don't--I mean, that's an excellent 
question about where we see the trends of who is improving. I 
think that you could see that on the East Coast in the 
developed areas because even the governments themselves are 
wanting to move the dirty industries out, so sometimes they're 
closed and sometimes they just move.
    Chairman Brown. The environmental movement, such as it is, 
I assume is more likely in the cities. There are more people, 
there is more education, there is more pollution. But you are 
seeing the origins of some protests and environmental movement 
in smaller communities?
    Ms. Turner. I mean, a few years back when the Public 
Security Bureau was reporting public protests, that in that 
number they were including mass protests in rural areas. We 
don't know the actual total number these days, but you do get 
Chinese news media reports talking about protests in rural 
areas and those often turn quite violent. The urban ones tend 
to be a little bit more peaceful, power numbers, and it's all 
on YouTube.
    Again, they are in the cities and the government is 
concerned about that. I think that that is an area where that 
is--you know, mind the gap. That while urbanites are able--you 
know, again, even when the Chinese--like in the Beijing example 
with the smog, where now Beijing is--in the country they are 
starting to measure PM2.5, their standards, and they are 
starting to say, ``Okay, coal-fired powerplants are going to 
have to reduce their PM2.5, empowering the Ministry of 
Environmental Protection to regulate them.
    I mean, there are a lot of positive changes. But as this is 
happening, China's energy consumption is still growing like 
gangbusters and so a lot of that is coal. So even as China 
makes these improvements, you are not going to see an overnight 
improvement of quality.
    So there are some questions. Liz talked about in her 
testimony about the central government being a little unsure 
where to go on this whole transparency issue, because while 
they do start taking some steps the actual progress on really 
cleaning up the environment could take a long time, again, even 
if you started now.
    Chairman Brown. Are Chinese companies, state-owned or 
otherwise, that invest in Africa or in the developing world 
generally, are they more environmentally responsible or are 
they less environmentally responsible where they invest outside 
the People's Republic of China than inside?
    Ms. Turner. Thanks for asking that question. We have 
actually been doing a series of meetings over the last couple 
of years, so we call it complex connections, looking at Chinese 
overseas investment. It really is a mixed bag. There are some, 
Friends of the Earth, Heritage Foundation that are looking at 
these Chinese investments, come and relate stories to me that 
some Chinese companies that are concerned about their global 
profile are starting to make decisions to be cleaner and 
    But then you do have instances--let's think about 
agricultural investments overseas. Okay. Take two steps back. 
Big companies like the oil companies, the extractive industries 
that have a global name, they might be more concerned about 
working on their environmental profile.
    We are starting to see though it's a new trend of 
provincial-level companies going out and making investments in 
the agricultural sector. These are much smaller, not as much 
transparency. Their names probably change every few weeks. So 
there is no one really necessarily minding the shop on how a 
lot of, particularly these smaller companies are doing 
    But I'm happy to say that there is more transparency and 
engagement, a lot of international--you know, the World 
Resources Institute, NRDC, and others, the Nature Conservancy, 
Conversation International, are working and talking to Chinese 
companies and government about this whole question of Chinese 
overseas investment and their footprint. So, they are talking.
    Chairman Brown. Okay. Thank you.
    Dr. Huang, you were pretty vigorously nodding your head 
when she was talking about demonstrations, sometimes violent, 
in smaller communities. What were you thinking?
    Mr. Huang. I think in a way it reflects the response toward 
the environmental pollution problems in China. It reflects the 
part of this process in emerging Chinese civil society in a way 
that is similar to what was going on in Japan in the 1960s and 
early 1970s. The citizens' movement there actually forced the 
government to make concessions, to start to take environmental 
problems seriously.
    I hope that China would follow Japan's path in that regard. 
While the situation in China today seems much worse if you look 
at the PM2.5 level, I do hope there is a solution to the 
    Chairman Brown. You said, since you're not that optimistic, 
but let me ask you a sort of broader question. In the 1970s, I 
think, maybe early 1980s, there were some cracks in Soviet 
authoritarianism when a group of scientists and other citizens 
began to protest about Lake Baikal, one of the largest bodies 
of fresh water in the world, the deepest lake, where the 
Soviets had put a lot of paper mills, and in Siberia where 
there were not a lot of people living, some, people without 
much power, the central government. Some say that was sort of 
one of the first cracks in the Soviet system in terms of a 
democracy movement. Does the environmental movement sort of 
lead the way in China on human rights, on democracy?
    Mr. Huang. Jennifer probably knows more than I do about 
this. I do think that the environment-oriented NGOs are 
actually the most active part of the civil society in China. If 
you compare them with health NGOs, certainly they are more 
active, and they are also more effective in a way. But if you 
compare them with their Russian counterparts, the difference is 
indeed large.
    We do see examples of public intellectuals, such as Hewei 
Fang and Li Chengpeng, who were very outspoken. But overall, I 
don't see that that many Chinese intellectuals--university 
professors, for example--are a part of the process.
    In a way, I think that might be related to the government's 
efforts since 1989 to co-opt intellectuals by improving their 
living conditions and aiming to make them happy, which made 
them less willing to speak out against the government.
    Chairman Brown. Okay. Thank you, Dr. Huang.
    Mr. Corbo, you talked about the implementation of the new 
food safety law being incomplete. What are the most important 
things that Congress should do? What are the most important 
parts that are not yet implemented and what should Congress do 
to make sure that they are? What do you suggest to us? You are 
an organizer, so you ought to know that.
    Mr. Corbo. Yes. Well, we've tried. The major rules have 
been stuck in the Office of Management and Budget [OMB] for an 
inordinate amount of time. Now, two of the rules did manage to 
get out, the one that deals with preventive controls in 
processing and then the produce rules, but the comment periods 
have been extended.
    When the law was passed, Congress set statutory deadlines 
that the major regulations, the produce rule, the preventive 
controls rule, the foreign supplier verification program needed 
to be implemented by July 4, 2012.
    Here we are in May 2013 and those rules have not been 
implemented. As a matter of fact, the foreign supplier 
verification rule that got sent over to OMB by FDA, I believe 
it was November 2011, is still there. It has not come out in 
proposed form. I know that a number of Members of Congress have 
sent communications to the Office of Management and Budget to 
release those rules.
    We just are perplexed as to why they are stuck there. I 
mean, FDA does need the regulatory apparatus in order to deal 
with this ever-increasing flow of imports. FDA cannot keep up 
with the volume and so those rules that were outlined have to 
be implemented and we have to get the comment period going.
    Chairman Brown. Other than poultry, what foods and drugs 
from China pose the greatest threat to Americans' health?
    Mr. Corbo. Well, I've talked to various former FDA 
inspectors and they think that the medical devices we import 
and the drugs we import pose a greater risk because of the fact 
that we really do not have a handle on the manufacturing 
practices in China.
    Food is our expertise and we are concerned. We are 
concerned about the safety of the food that is coming into this 
country. This pet treat thing is something that we originally 
were not going to get involved in. It just happened by pure 
accident that last year, after coming back from a meeting at 
USDA asking them what is the status of the poultry exports from 
China for human consumption, then when I got back to the office 
all of a sudden I saw this alert from FDA warning pet owners 
not to feed their pets Chinese jerky treats, chicken jerky 
treats, that set us on the path to find out what was going on 
here. How was this product getting in?
    Chairman Brown. Thank you, Mr. Corbo.
    Dr. Turner, thank you. Dr. Huang, thank you. Mr. Corbo, 
thank you. We will have--I would like to enter Cochairman 
Smith's statement and Elizabeth Economy's statement also into 
the record. If any commission members have questions of you, we 
will get them to you quickly. Please answer them within a week.
    Thank you again for being here. The Commission hearing is 
adjourned. Thank you all.
    [The prepared statement of Cochairman Smith appears in the 
    [The prepared statement of Elizabeth Economy appears in the 
    [Whereupon, at 11:22 a.m., the hearing was concluded.]
                            A P P E N D I X


                          Prepared Statements


             Prepared Statement of RADM Anne Schuchat, M.D.

                              may 22, 2013
    Thank you, Senator Brown, Representative Smith and distinguished 
members of the Commission. It is a pleasure to appear before you 
representing the U.S. Centers for Disease Control and Prevention (CDC), 
one of the Nation's leading health protection agencies and an operating 
division of the Department of Health and Human Services. Throughout its 
history, CDC and its local, national, and international partners have 
worked to detect, respond to and prevent global health security 
threats. Today I would like to focus on how CDC's collaborations with 
China help to protect Americans' health and well-being, while 
supporting China's efforts to protect the health of its own citizens.
                      cdc's global health efforts
    CDC's global health mission is to protect and improve health 
globally through science, policy, and evidence-based public health 
action. CDC works in global health to protect the people of the United 
States; prevent disease; contribute to stable, productive societies; 
and save lives worldwide. CDC achieves its global health mission by 
leveraging its core technical strengths and partnerships. The Agency's 
world-class capacity to respond to disease outbreaks and other public 
health emergencies, our staff on the ground in approximately 55 
countries, and our peer-to-peer working relationships with Ministries 
of Health, enables CDC to be on the scene early in events of public 
health concern. CDC strives not only to implement programs around the 
world to improve health, but also to build sustainable in-country 
capacity, institutions, partnerships, and systems to address global 
public health issues.
                              cdc in china
    China is an important geopolitical and public health partner for 
the United States. CDC and the Chinese government have collaborated on 
public health priorities that affect China, the United States, and the 
global community for more than 30 years. CDC focuses its work in China 
on emerging and re-emerging infectious diseases, immunization, non-
communicable diseases, emergency preparedness, laboratory systems 
development, epidemiology training, communications, and public health 
workforce development.
    CDC's work in China is conducted through partnerships with Chinese 
public health institutions at the national, provincial and local level, 
as well as Chinese academic institutions and non-governmental 
organizations. In addition, the CDC works with American companies, 
foundations and universities as well as multilateral organizations such 
as the World Health Organization (WHO) to achieve our public health 
goals in China. CDC's collaborative projects across China have built 
strong bilateral relationships between China and the United States, and 
also help to shape China's own multilateral and bilateral engagements 
on global health. A sign of the strength of these collaborations is 
China's decision to designate their district, provincial, and national 
public health institutes ``CDCs''.
    Since the early 1990s CDC has had at least one technical staff 
member assigned to China, and the earliest assignees worked on birth 
defects and immunization. In 2003, China was the epicenter for the 
global outbreak of Severe Acute Respiratory Syndrome, or SARS. 
Disruption in travel, trade, and local economies led to over 30 billion 
dollars in economic losses to affected countries. China and the world 
suffered from the initial lack of transparency and delays in 
confronting their epidemic. They subsequently invested heavily in 
improving their public health infrastructure, which helped them host 
the 2008 Olympics in Beijing and contributed to their effective 
response to the 2009 H1N1 influenza pandemic. Thus far, their efforts 
in the 2013 H7N9 case have demonstrated tremendous advancements.
    CDC's Global AIDS Program office in China was established in 2003-
2004 with funding from the U.S. President's Emergency Plan for AIDS 
Relief (PEPFAR). CDC works closely with the Chinese national response 
to HIV/AIDS, led by the National Center for AIDS/STD Prevention and 
Control at the Chinese Center for Disease Control and Prevention (China 
CDC). The Chinese government provides funding for anti-retroviral 
treatment for all eligible patients, while CDC provides technical 
assistance on guideline and policy development; innovative approaches 
to care, treatment and prevention; strategic information; and 
laboratory systems development. The collaboration relies on a data-
driven, evidence-based approach to prevent and control HIV, especially 
in high-risk groups.
    Although CDC began influenza collaboration with China in the late 
1980s, the Memorandum of Understanding on Emerging and Re-emerging 
Infectious Diseases between the U.S. Department of Health and Human 
Services (HHS) and the Chinese Ministry of Health helped formalize the 
relationship on infectious Diseases. In 2004 CDC established a 
cooperative agreement with China CDC in response to the emergence of 
human infections of avian influenza H5N1 virus. Since then, US CDC and 
China CDC cooperative agreements have improved China's influenza 
surveillance network and also strengthened influenza response capacity 
at all levels.
    CDC's Global Disease Detection (GDD) program works to identify and 
contain infectious disease outbreaks before they spread globally. The 
China GDD program began in 2005 to strengthen China's national capacity 
to detect and respond to emerging threats, building on lessons learned 
from the response to the Severe Acute Respiratory Syndrome (SARS) 
emergency. I was in China to assist WHO with the SARS response in 2003, 
and have seen the extraordinary progress in their public health 
response and capacity since then.
    CDC first established the Field Epidemiology Training Program, to 
train ``disease detectives'' to lead investigations and effective 
responses to public health threats. Through this effort, more than 100 
of China's top epidemiologists are now able to respond to health 
emergencies in China. China's FETP began with a focus on tuberculosis 
(TB), and expanded to include laboratory capacity, foodborne disease, 
healthcare associated infections, hepatitis, non-communicable disease, 
and public health emergency response. FETP staff from China and the 
United States has helped conduct approximately 500 outbreak 
investigations since 2003.
    Our partnership with China also now supports critical public health 
priorities in other countries, including Chinese staff participation in 
the CDC-WHO Stop Transmission Of Polio (STOP) missions, further 
enabling China to fulfill its goal of becoming a global health response 
    The close collaboration between the United States and China CDC has 
yielded important results, including the designation of the Chinese 
National Influenza Center in October 2010 as one of five WHO 
Collaborating Centers for Reference and Research on Influenza--the only 
such Center in a low or middle-income country. In addition, together we 
have made positive strides in the capacity of the Chinese to respond to 
public health emergencies as demonstrated by the 2011 response to an 
outbreak of polio in China's Xinjiang province, which was caused by a 
poliovirus imported from Pakistan. China's immediate and effective 
response was described as ``a true model response'' by WHO.
    China's large population and strong capacity to conduct 
sophisticated research has facilitated key studies that answer 
questions of global import. Research conducted in China by CDC with 
Chinese collaborators provided critical data that supported the 
decision of the U.S. Food and Drug Administration in 1996 to require 
all United States manufacturers of enriched cereal grain products to 
fortify those products with folic acid. As a result of this decision, 
the rates of spina bifida and other serious birth defects of the brain 
and spine have decreased significantly in the United States and in 
other countries that have implemented similar policies. Furthermore, 
continued collaboration with the Chinese using the original research 
infrastructure developed for the original study has allowed CDC to 
answer questions about the safety of the United States folic acid 
fortification program. Currently, plans are underway to initiate 
additional research using this collaborative platform to evaluate the 
potential of folic acid consumption during pregnancy to reduce 
childhood cancer. China is also implementing one of the largest 
community trials of salt reduction and hypertension management, which 
has the potential to have impact on heart disease and stroke 
                        avian influenza a (h7n9)
    Right now in China, authorities have moved aggressively to limit 
the spread of avian influenza A (H7N9). This strain had never been 
detected in humans until March of this year. The government in China is 
working to monitor the illness, share information quickly and intervene 
aggressively. The support provided by CDC through our cooperative 
agreements for influenza has emphasized the integration of virologic 
and epidemiologic surveillance in the interest of obtaining the most 
complete picture possible of influenza activity. CDC's technical 
collaboration with China over the past decade has contributed to the 
ability of Chinese laboratory scientists to rapidly sequence the genome 
of multiple viral isolates of avian influenza A (H7N9), and post 
sequence data promptly for others to see. China has shown expertise and 
transparency during the avian influenza A (H7N9) response both in terms 
of epidemiologic information-sharing with global public agencies, as 
well as timely health communications to the public. These collaborative 
efforts are essential to the health security of both the American and 
Chinese people. The Chinese public health capacity is now greatly 
improved and our information about the evolving situation is much more 
complete than was the case with SARS 10 years ago.
    For instance, the number of influenza like illness (ILI) sentinel 
surveillance sites in China has increased from 92 in 2005 to 554 in 
2013, greatly expanding the geographic reach and representativeness of 
their surveillance network. The number of network labs capable of 
testing for influenza has grown from 63 to 409. China has also enhanced 
the complexity of laboratory tests done for characterization of 
influenza viruses. With these expansions comes a much greater 
contribution to the ability to monitor influenza activity globally, 
contribute viruses to the WHO Global Influenza Surveillance and 
Response System and to detect outbreaks and unusual cases of 
respiratory infection. The improved global network has not only 
strengthened China's preparedness, but also aided the global public 
health community with the detection of unusual respiratory disease 
activity and the early detection of avian influenza A (H7N9). The 
bottom-line with avian influenza A (H7N9) is that China continues to 
collaborate with the CDC and has welcomed United States collaboration.
                     global health security threats
    We believe the sustained support for our work in China directly 
protects Americans. Unfortunately, over 80 percent of countries around 
the world still lack the essential resources and sufficient health 
infrastructure to detect, assess, notify, and respond to public health 
emergencies of international concern.
    CDC helps promote compliance and coordination for the United States 
and WHO member states, and supports WHO member states with limited 
resources to develop and fully implement essential detection and 
control capacities. CDC's global health resources support countries to 
fulfill these commitments by strengthening networks of laboratories, 
surveillance systems, and training programs in field epidemiology, 
laboratory science, and risk communication.
    CDC strives to address global health security threats 
comprehensively through activities that work on multiple, complementary 
levels by detecting threats early; responding effectively; to 
containing disease outbreaks; communicating risks; and preventing 
avoidable catastrophes by working with other USG agencies to ensure the 
global food, drug, and medical device supply is safe. CDC partners with 
governments to improve the safety and security of their laboratories 
and other facilities that work with dangerous organisms to prevent the 
intentional or unintentional release of disease agents.
    China has been an engaged partner in efforts to strengthen global 
health security, and CDC's partnership has led the Chinese government 
to make significant investments in their own capacity to detect and 
respond to health threats. However, most of the world has not made 
these commitments or reached China's level of capacity, and United 
States leadership is needed to protect Americans and the world.
                  conclusion: the value of partnership
    China has been an important partner to align short-and long-term 
United States strategic, economic and health protection interests. The 
recent experience with avian influenza A (H7N9) has thus far shown that 
strategic investments in human capacity can yield important impacts on 
illness prevented and lives saved. In addition, continued deployment 
and expansion of resources on the ground will ensure U.S. leverage in 
Global Health Security as China rapidly expands its public health 
assets, with support from both domestic resources and other 
international partners. China has choices among its numerous 
international partnerships influencing the development of burgeoning 
public health system. The United States' continued involvement will 
ensure influence at critical points in China public health security 
development. Given the interconnectedness of global travel and trade, 
the rise of emerging and re-emerging disease threats, and the potential 
for deadly pathogens or products to be inadvertently or intentionally 
released, continued investment in technical assistance and broader 
partnership with China and the world remain strategically important for 
United States interests and global public health.

        Prepared Statement of Steven M. Solomon, D.V.M., M.P.H.

                              may 22, 2013
    Good Morning, Chairman Brown, Co-Chairman Smith, and Members of the 
Commission. I am Dr. Steven Solomon, Associate Director for Global 
Operations and Policy in the Office of Global Regulatory Operations and 
Policy 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 efforts to ensure 
global product safety and quality and our work related to China.
    FDA is responsible for protecting the public health by helping to 
ensure the safety, effectiveness, and security of human and veterinary 
drugs, vaccines and other biological products for human use, and 
medical devices. The Agency also is responsible for the safety and 
security of our nation's food supply, cosmetics, dietary supplements, 
products that emit electronic radiation, and for regulating tobacco 
products. Imported products must meet the same standards as those 
produced domestically.
    In my testimony today, I will discuss the challenges of an 
increasingly globalized marketplace, describe FDA's actions to 
safeguard the global supply chain, and discuss FDA's activities related 
to China.
                      challenges of globalization
    Sweeping economic and technological changes have revolutionized 
international trade over the last several decades, creating a truly 
global marketplace for goods and services. Accounting for 20 to 25 
percent of all U.S. consumer spending, products regulated by FDA are a 
substantial component of this global economy. Food and medical 
products, and their ingredients and components--products that directly 
and profoundly affect the health and welfare of the U.S. public--are 
increasingly sourced from abroad. Today, FDA-regulated products 
originate from more than 200 countries and territories and pass through 
more than 300 U.S. ports. The number of FDA-regulated shipments has 
more than tripled from 8 million import entry lines per year a decade 
ago to 28 million entry lines in Fiscal Year (FY) 2012. In FY 2013, 
entry lines are anticipated to reach 34 million. By way of background, 
the Agency tracks import shipments using entry lines. An entry line 
means each portion of a shipment that is listed as a separate item on 
an entry document. As trade increases and U.S. consumers continue to 
demand global products, FDA's ability to ensure the safety and quality 
of these imported products will depend on its execution of a myriad of 
global engagement strategies.
    Americans benefit greatly from global sourcing of products. For 
example, U.S. consumers can choose from a wide variety of fruits and 
vegetables year round, regardless of the domestic growing season. Ten 
to fifteen percent of all food consumed by U.S. households is imported. 
Approximately 50 percent of fresh fruits, 20 percent of fresh 
vegetables, and 80 percent of seafood consumed in the U.S. are 
imported. Health professionals can also draw on drugs and medical 
devices developed anywhere in the world, if they have been approved for 
use in the United States. Approximately 40 percent of finished drugs in 
the United States come from overseas, as well as more than 50 percent 
of all medical devices. Approximately 80 percent of the manufacturers 
of active pharmaceutical ingredients are located outside the United 
    This rapid globalization of commerce poses challenges. For example, 
some products entering the United States are made or grown in countries 
that lack the necessary regulatory oversight to ensure their safety. 
Greater numbers of suppliers, more complex products, and intricate 
multinational supply chains can introduce risks to product safety and 
quality. These factors also provide more opportunities for intentional 
or unintentional adulteration and exposure to contaminated products for 
consumers. I will discuss below the ways in which FDA is pursuing a 
comprehensive strategy to enhance the safety of imported products and 
establish effective global partnerships.
    Many of the challenges associated with globalization manifest 
themselves in China. Historically, FDA has been faced with several 
public health threats related to imports from China. These include 
Chinese suppliers of heparin (a critical drug to prevent blood clots), 
who substituted a lower-cost, adulterated raw ingredient in their 
shipments to U.S. drug makers, causing deaths and severe allergic 
reactions. Other examples involved the addition of melamine to pet food 
made in China, which sickened and killed cats and dogs in the United 
States, and the presence of animal drug residues in seafood raised 
through aquaculture from China.
    FDA's success in protecting the American public depends 
increasingly on its ability to reach beyond U.S. borders and engage 
with its government regulatory counterparts in other nations, as well 
as with industry and regional and international organizations, to 
encourage the implementation of science-based standards to ensure the 
quality and safety of products before they reach our country. FDA is 
working with its many partners to enhance responsibility and oversight 
for safety and quality throughout the supply chain.
                  safeguarding the global supply chain
    To address the challenges described above and strengthen 
protections for American consumers, FDA is utilizing a variety of 
engagement strategies, in collaboration with our many partners. Our 
efforts are in line with the 2012 U.S. National Strategy for Global 
Supply Chain Security, which emphasizes a layered, risk-based approach 
to achieving global supply chain systems that are secure, efficient, 
and resilient. In 2011, FDA released its report, Pathway to Global 
Product Safety and Quality, which outlines the Agency's strategy to 
transform itself from a predominantly domestically-focused Agency to 
one that is fully prepared for a complex, globalized regulatory 
environment. I would like to discuss just a few of the activities we 
are pursuing as part of this strategy.
    International Offices and Foreign Posts. FDA's international 
offices and posts help to build strong partnerships with our foreign 
counterparts by providing enhanced opportunities for cooperation and 
capacity building. They also expand our knowledge base and provide a 
platform for inspection of foreign facilities. We now have a permanent 
FDA presence overseas in 12 foreign posts in nine countries. Our 
overseas employees are located in China, India, Latin America, Europe, 
the Middle East, and South Africa.
    Risk-based Monitoring of Imported Products. While FDA does not have 
sufficient resources to physically inspect all imported shipments, even 
if we had such resources, physically inspecting all imports would be 
neither practical nor strategic. However, the Agency electronically 
screens all imports using an automated risk-based system to determine 
if shipments meet identified criteria for physical examination or other 
review. To enhance our ability to target high-risk products, FDA 
developed the Predictive Risk-based Evaluation for Dynamic Import 
Compliance Targeting application, or PREDICT. This is a sophisticated 
screening system that uses intelligence from many sources--such as 
intrinsic product risks, past inspection results, intelligence data, 
and even information about such threats as extreme weather that could 
spoil a shipment--to provide the entry reviewer with risk scores on 
every import line. PREDICT utilizes information sources that include 
FDA and U.S. Customs and Border Protection (CBP) data, as well as data 
collected from our foreign offices, foreign regulatory counterparts, 
other federal agencies, and our state counterparts. It also utilizes 
risk analyses we receive through agreements with academic institutions 
and international organizations. As we continue to increase data 
sharing with state, federal, and foreign government partners, as well 
as private partners, we will continue to incorporate more information 
into PREDICT. This system allows FDA to focus its resources on those 
imports that are most likely to pose a danger, while at the same time 
facilitating entry of low-risk products. FDA, the United States 
Department of Agriculture (USDA), and the Department of Homeland 
Security have also developed improved systems for monitoring for the 
potential of economically-motivated adulteration, which uses CBP and 
trade data.
    Technical Cooperation and Capacity Building. FDA recognizes the 
need to engage in effective regulatory cooperation with our global 
partners. The capacities of governments to manage, assess, and regulate 
products within increasingly complex supply chains are a fundamental 
factor affecting product safety and efficacy. FDA is working 
strategically with a range of countries to provide information, tools, 
training, and exchange programs that contribute to building or 
strengthening regulatory capacity of our trading partners. I will 
describe later in my testimony some of our collaborations with Chinese 
government officials.
    Implementing Major New Laws. In addition to these activities, FDA 
is implementing significant new authorities provided by Congress that 
will help ensure the safety of imported products.

         The FDA Food Safety Modernization Act (FSMA). FSMA, 
        the most sweeping reform of our food safety laws in more than 
        70 years, creates a modern food safety system. The new 
        authorities increase FDA's ability to focus on preventing, 
        rather than reacting to, food safety threats, share information 
        with public health and regulatory counterparts, and make 
        informed, risk-based decisions.

    Earlier this year, FDA published for comment two proposed rules 
that would establish science-based standards for the prevention of 
foodborne illnesses--one on safe growing and handling practices for 
produce and another on prevention practices in facilities that process, 
handle, and store human food. These standards, when finalized, will 
apply to both domestic and foreign firms.
    FSMA also provides other new tools to hold imported food to the 
same standards as domestic foods. For the first time, once the 
regulations are in place, importers will have explicit responsibility 
to verify that their foreign suppliers have adequate preventive 
controls in place to ensure that the food they produce is safe. The law 
also provides an incentive for importers to take additional food safety 
measures by directing FDA to establish a voluntary program through 
which imported food shipments may receive expedited review for 
importers that have taken certain measures to ensure the safety of the 
food they import. In addition, FSMA directs FDA to develop a 
comprehensive plan to expand the technical, scientific, and regulatory 
food safety capacity of foreign governments and their industries. One 
component of the plan is to address training of foreign governments and 
food producers on U.S. requirements for food safety.

         The Food and Drug Administration Safety and Innovation 
        Act (FDASIA). With the passage of FDASIA last year, Congress 
        granted FDA important new authorities, reauthorized human drug 
        and device user fees, and authorized new user fees for generic 
        human drugs and biosimilar biologics. These authorities and 
        fees are intended to maintain a predictable and efficient 
        review process for medical products, provide incentives for 
        developing new antibacterial and antifungal drugs, combat drug 
        shortages, and enhance the Agency's efforts to ensure that 
        American consumers have more timely access to safe, high-
        quality, and affordable medicines.

    Title VII of FDASIA focuses on improving the safety and integrity 
of drugs imported into, and sold in, the United States. The new 
authority increases FDA's ability to collect and analyze data to enable 
risk-informed decision-making, advance risk-based approaches to 
facility evaluation, partner with foreign regulatory authorities to 
leverage resources through information-sharing and recognition of 
foreign inspection, and drive safety and quality throughout the supply 
chain through the use of strengthened tools. For example, the law 
requires foreign and domestic companies to provide complete information 
on threats to the security of the drug supply chain and improves 
current registration and listing information, making sure FDA has 
accurate and up-to-date information about foreign and domestic 
    The new authorities provided by FSMA and FDASIA align with the 
strategies outlined in the Pathway report. Both FSMA and FDASIA promote 
collaboration with global regulatory partners, utilizing data systems 
to facilitate information-sharing and risk analytics and leveraging the 
efforts of our regulatory and public health partners. We are working 
hard to implement both of these important laws.
                    fda activities related to china
    Nowhere is the shift toward a global marketplace more evident than 
in U.S. trade with China. China is the source of a large and growing 
volume of imported foods, drugs, and ingredients. During FY 2007-2012, 
the total number of shipments of FDA-regulated products from China 
increased from approximately 1.3 million entry lines to 4.5 million 
lines. Of the 4.5 million lines arriving from China in FY 2012, 67 
percent were drugs and devices, and 6 percent were human food products. 
Three percent of our imported food, 8 percent of animal food, and 5 
percent of drugs and biologics come from China.
    As the number of products imported from China has increased, so 
have the challenges. There are currently 74 active FDA Import Alerts 
that include firms located in China. Forty of the Import Alerts concern 
food products. These alerts signal FDA investigators at the U.S. border 
to pay special attention to a particular product, or a range of 
products from a particular country, producer, shipper, or importer. 
Under these Import Alerts, products may be detained at the border and 
may be refused admission into U.S. commerce unless the importer is able 
to demonstrate that the products are in compliance with all laws and 
regulations. There are currently nine country-wide Import Alerts for 
China. For example, in September 2008, FDA became aware of thousands of 
infant illnesses in China associated with the consumption of infant 
formula reported to contain melamine. To keep these products out of the 
country and protect American consumers, the Agency issued an Import 
Alert for milk and milk products from China because of the presence of 
melamine. In addition, FDA continues to find residues of several animal 
drugs in shipments of aquacultured seafood products from China. As a 
result, FDA has imposed a country-wide Import Alert on all farm-raised 
catfish, basa, shrimp, dace, and eel from China.
    FDA is taking several actions in response to these challenges. FDA 
has 13 officers posted in three locations in China: Beijing, Shanghai, 
and Guangzhou. This includes eight U.S. civil servants and five Chinese 
staff. The mission of FDA's China Office is to strengthen the safety, 
quality, and effectiveness of FDA-regulated products produced in China 
for export to the United States. FDA's China Office works to fulfill 
this mission through:

         Collaborating, capacity-building, and confidence-
        building with Chinese regulatory counterparts at the central, 
        provincial, and municipal level;
         Reaching out to regulated Chinese firms that wish to 
        export their products to the United States to enhance 
        understanding of and compliance with FDA standards;
         Monitoring and reporting on conditions, trends, and 
        events that could affect the safety and effectiveness of FDA-
        regulated products exported to the United States;
         Conducting inspections at facilities that manufacture 
        FDA-regulated goods;
         Increasing the knowledge base and understanding of key 
        stakeholders about FDA regulations and science-based approaches 
        to strengthen product safety, quality, and effectiveness; and
         Working closely with other relevant offices within the 
        U.S. Embassy and Consulates in China, such as the Foreign 
        Commercial Service of the Department of Commerce, the Foreign 
        Agricultural Service of USDA, and the Centers for Disease 
        Control and Prevention of HHS.

    Food and animal feed exported from China are regulated by the 
General Administration of Quality, Supervision, Inspection, and 
Quarantine (AQSIQ). This food-export system is separated from China's 
system for regulating its domestic food supply. On the domestic side, 
the Ministry of Agriculture has responsibility for primary food 
production, and the China Food and Drug Administration (CFDA) has 
responsibility for food processing, food in retail circulation, and 
restaurants. Until March 2013, these responsibilities had been held by 
three different ministries within the Chinese Government. FDA, through 
efforts led by its China Office, has established active working 
relationships with the food safety agencies in Beijing and will 
continue to work with key stakeholders in China to strengthen the 
safety of food exported to the United States by encouraging the 
implementation of science-based standards. On the human drug side, 
domestic drugs and certain exported drugs are regulated by the CFDA. 
Domestically, AQSIQ and the Ministry of Agriculture share 
responsibility for the regulation of animal drugs, animal feed, and 
feed ingredients.
    I would now like to provide some examples of our collaborations 
with Chinese government officials.
    In mid-April, FDA met with CFDA in Washington to discuss the 
substantive collaboration between FDA and CFDA across more than a dozen 
topic areas. While much of the strengthening of our relationship with 
CFDA has come through day-to-day collaboration between FDA's China 
Office and CFDA officials in Beijing, there are other significant ties 
in multiple areas across our agencies, such as:

         A working group on economically-motivated adulteration 
        (the fraudulent substitution of a substance in a product to 
        increase value or reduce production costs for the purposes of 
        economic gain) meets on a regular basis by video, linking 
        Washington-based experts with CFDA's key decision-makers.
         Experts from FDA's Center for Devices and Radiological 
        Health now meet regularly with their counterparts from CFDA 
        under the auspices of the International Medical Devices 
        Regulatory Forum, as China has recently joined the Forum.
         FDA and CFDA collaborate closely under the auspices of 
        the World Health Organization's Working Group for Member States 
        on Substandard, Spurious, Falsely-Labeled, Falsified and 
        Counterfeit Medicines. FDA and CFDA inspectors regularly 
        observe one another's inspections.
         On May 21, 2013, FDA and CFDA co-hosted a workshop to 
        enhance our collaboration in the fight against Internet-based, 
        illegal distribution of adulterated drugs.

    Other examples include:

         Between 2010 and 2012, FDA held a series of workshops 
        on good clinical practices for Chinese inspectors who inspect 
        sites that conduct trials to support the development of 
        pharmaceuticals. Prior to the workshops, CFDA had few well-
        trained inspectors able to conduct inspections of clinical 
        research sites. FDA's training in this area helped CFDA to 
        establish its national clinical research inspectorate. FDA 
        regularly invites these CFDA inspectors to observe Agency 
        clinical research inspections in China to continue to enhance 
        CFDA's understanding of FDA requirements.
         At the request of CFDA, FDA's China Office and Office 
        of Criminal Investigations worked with U.S. Internet-hosting 
        companies to shut down 16 Chinese-language websites that 
        illegally sold unapproved medical products through servers 
        located in the United States.
         In 2012, CFDA provided to FDA's China Office a list of 
        Chinese pharmaceutical firms against which CFDA had taken 
        regulatory action because of their failure to comply with 
        relevant standards for good manufacturing practices. From the 
        list, FDA identified 61 firms that had shipped products to the 
        United States and targeted these firms as priorities for 
         FDA's country-wide Import Alert on five species of 
        aquaculture fish has been in place since 2007, yet FDA 
        continues to find positive samples of illegal drugs and 
        additives from Chinese aquaculture products shipped to the 
        United States. In November 2012 and May 2013, FDA and AQSIQ 
        held workshops for members of Chinese industry to address 
        concerns regarding aquaculture practices for fish farms. These 
        workshops have significantly enhanced FDA's understanding of 
        China's oversight system for aquaculture products, and have 
        provided Chinese industry with a clearer understanding of FDA's 
        requirements and practices.
    Thank you for the opportunity to describe some of FDA's actions to 
address the challenges of an increasingly globalized marketplace and to 
discuss our work in China. FDA is pursuing a comprehensive strategy to 
enhance the safety of imported products and establish an effective 
global safety net.
    Firms always have the primary responsibility to produce safe 
products, but it is important that governments provide meaningful and 
robust regulation. FDA is working with China to help them improve their 
regulatory system and to educate them on the new standards being 
implemented in our regulatory system.
    I am happy to answer any questions you may have.

                Prepared Statement of Jennifer L. Turner

                              may 22, 2013

Seeing Through the Smog? Pushing for Pollution Information Transparency 
             and Environmental Public Interest Law in China

    In the 36 years since opening up to the world, China's economy is 
still booming and it is easy to talk in superlatives about the 
country--fastest growing economy, largest and most populated cities, 
tallest dams, biggest consumer of coal, and the list goes on. China's 
rapid economic growth has lifted millions out of poverty and promoted 
wealth in the country, but at a major cost to the environment. China is 
now burdened with some of the dirtiest air and water in the world. 
There remain huge unknown threats in terms of soil quality, 
biodiversity losses, and long-term impacts of pollution on the public's 
health. The Chinese government has long acknowledged the growing litany 
of environmental woes and passed countless laws and regulations, but 
enforcement remains a key obstacle.
    Since the mid-1980s, Chinese government and research institutes 
have actively engaged with bilateral and multilateral aid agencies as 
well as U.S. environmental NGOs, universities, foundations, and 
research institutes to address China's pollution and other 
environmental challenges. This international engagement has assisted 
Chinese policymakers in drafting and passing environmental and clean 
energy laws, regulations and standards, and led to joint researches 
between Chinese and international institutes. International 
organizations also have helped train and empower Chinese environmental 
policymakers, lawyers, judges, journalists, researchers, and NGOs to 
work on public participation, open information, and other environmental 
governance issues. For example, Vermont Law School, Natural Resources 
Defense Council, and the American Bar Association have all worked with 
the Chinese NGO Center for Legal Assistance for Pollution Victims to 
train Chinese judges, lawyers and local officials on public hearings 
for environmental impact assessments and public interest law cases. 
Over the last three decades, U.S. environmental NGOs have played a 
pivotal role in creating new kinds of cooperation and dialogues around 
environmental problems, forging long-lasting partnerships among Chinese 
and U.S. researchers, NGOs, and government agencies.
    As the Chinese government has passed new laws and measures on 
environmental information transparency and public participation, the 
growing cohort of Chinese environmental journalists, lawyers, 
researchers and activists have gained more political space in which to 
operate and are placing greater bottom-up pressure on the government to 
improve China's weak enforcement of environmental laws and regulations. 
The expansion of ``green'' laws and the increasing accessibility to 
information on environmental issues in China has paved the path for a 
growing national consciousness rallying around the right to a clean 
environment, and Chinese citizens are increasingly willing to petition, 
complain, and protest the worsening environmental quality.
    Below is a brief overview of some emerging trends of transparency, 
public participation, and public interest lawsuits around environmental 
issues in China. While there are many encouraging developments, 
ultimately these new policy tools are but one part of what needs to be 
larger environmental governance reforms in China.
                   demands for pollution information
    In recent years, Northern China has witnessed major air pollution 
incidents. But the smog that blanketed Beijing and much of northern 
China in December 2012 and the early months of 2013 was particularly 
severe and worrying for government and citizens alike. During this 
time, pollution levels for fine particulate matter (PM2.5) rose two, 
three or sometimes four times beyond the emergency level of 250 
micrograms per cubic meter. Chinese citizens broadcasted their 
frustration with the smog through social media and some Chinese NGOs 
rented out personal air quality monitors to have citizens then post the 
registered ``hazardous'' readings online alongside official government 
air quality reports that listed the air pollution as ``fair'' or 
``moderate.'' Through these public awareness campaigns, Chinese online 
citizens (netizens) successfully advocated for the central government 
to adopt PM2.5 standards that match those being tweeted by the U.S. 
Embassy in Beijing. Greenpeace China and Beijing University School of 
Health issued a timely study that reported 8,600 early deaths from 
PM2.5 in Beijing, Xi'an, Guangdong and Shanghai in 2012. The Chinese 
news media was highly critical of the government's failure to lessen 
the, literally, choking pollution. The public's extensive criticism 
online and harsh news media reporting were effective in prompting the 
government to make some of the following policy changes:

         China's State Council mandated rapid deployment of 
        PM2.5 monitoring and issued real-time data to the public. As of 
        January 2013 a total of 496 monitoring sites have been set up 
        in the 74 Chinese cities and the central government aims that 
        all prefecture-level cities establish urban air quality 
        monitoring program by 2016.\1\
         The 12th Five-Year Plan for Energy Development, which 
        came out in January 2013 introduced a noteworthy and 
        unprecedented pollution control policy target. Specifically, 
        energy producers are required to cut small particulate 
        emissions (PM2.5) by 30 percent over the next five years. Coal-
        fired powerplants and oil companies will now be targeted for 
        stricter regulation.
         To improve the city's dismal air quality, the Beijing 
        Development and Reform Commission announced a new round of 
        targets to cut coal use, capping coal use at 15 million tons a 
        year by 2015, the end of the 12th Five-Year Plan period, which 
        represents a 60-percent drop from the city's 2010 use.
         The central government announced plans to upgrade 
        vehicle fuels quality and tighten auto emission standards.
         The smog incident catalyzed a new dialogue in China 
        about how to evaluate local officials for actual environmental 
        improvements, whereas in the past, they were recognized for 
        installing pollution control equipment, even though the 
        equipment may not be operating.

    While Chinese government agencies have long issued ambitious 
statements addressing pollution, the difference in the latest air 
pollution case is that the general public, NGOs and the news media were 
more vigilant and willing to demand environmental information and 
accountability from officials, widely expressing and sharing their 
discontent online. A recent Shanghai Jiao Tong University survey of 
3,400 Chinese citizens across 34 cities revealed that more than three-
quarters of the respondents would be willing to protest against 
polluting industries.\2\ Nearly 80 percent believed environmental 
protection should be a higher priority than economic development. \3\
         successes and failures in using open information tools
An NGO's Success . . .
    A growing number of Chinese NGOs are using open information 
measures and Internet ``naming and shaming'' as tools to pressure 
polluting industries and inattentive government agencies to halt 
pollution. Ma Jun, China's leading water pollution activist and founder 
of the NGO Institute for Public and Environmental Affairs (IPE), is 
perhaps the leader in using open information measures to motivate 
better environmental performance from governments and companies. In 
2006, drawing on publically available information of polluters, IPE 
created online water and air pollution databases and publicized a list 
of polluters now numbered more than 125,000. A broad range of 
stakeholders--particularly international and Chinese companies--use 
these databases as a tool to monitor the environmental quality and 
suppliers' performance in China. International and Chinese companies 
who request audits to clear their names off of his well-publicized 
website often work with IPE's Green Choice Alliance--a group of 30 
grassroots Chinese green NGOs who help oversee audits of the companies. 
The Alliance has motivated hundreds of factories with poor pollution 
records to publicly disclose their work plans to clean up their 
    Taking his transparency work a step further, in 2009, Ma Jun's NGO 
began working with a U.S. NGO, the Natural Resources Defense Council, 
to create a pollution information transparency index (PITI), which 
examines and ranks government performance in disclosing environmental 
information and respond to public appeals in 113 cities. The index is 
not intended to be solely a finger pointing exercise, but rather to 
help educate and motivate city officials to view information 
transparency as a valuable tool in promoting better environmental 
. . . and a Lawyer's Failed Attempt
    Lawyers too are working to uncover poor environmental performance 
and test China's 2008 Open Environmental Information Measures, which 
gave citizens the right to request pollution information from 
government and industry. Soil pollution is a quieter environmental 
crisis facing China that only recently made headlines after Beijing 
lawyer Dong Zhengwei unsuccessfully applied to access data on the 2006 
national soil pollution survey, conducted by the Ministries of 
Environment and Land Resources. Ministry of Environmental Protection 
(MEP) declined Dong's request citing the survey results as a ``state 
secret.'' At least three state-run newspapers (People's Daily, China 
Daily, and Xinhua) criticized China's environmental authorities for 
arguing that soil pollution data is a ``state secret'' and thus not fit 
for public consumption.
    Dong subsequently pressed for an administrative review from MEP; 
but on May 8, 2013, the lawyer received MEP's administrative review 
decision that he still could not receive the information. The MEP 
justified the denial stating that the survey's information on soil 
pollution was only a general overview of the situation with more 
studies underway, and once the MEP completed its investigation it would 
release the results to the public.
    China currently lacks the laws, regulations and standards that 
could guide MEP in requiring clean up and assigning liability, a gap 
that also could explain some of MEP's hesitancy in releasing what could 
be very unsettling information on soil quality. Thus, without 
legislation of action, the open information measures end up being 
simply an institution in waiting.
    Although the ministries of environment and land and resources have 
not fully released the national soil survey results, researchers around 
China began publishing sobering articles on the scope of the problem. A 
Nanjing Agricultural University study hypothesized that up to 10 
percent of China's rice may be contaminated with cadmium, identifying 
rice from Hunan, Guizhou, and Guangxi Zhuang Autonomous Region as being 
potentially the most heavily contaminated. China's oldest environmental 
NGO, Friends of Nature, released its Annual Report on Environment 
Development of China on April 11, 2013 which highlighted the growing 
challenge of soil pollution. This report cited Chinese studies that 
found 12.1 percent of China's farmland is polluted to some degree with 
heavy metals. The report also indicates that China is already suffering 
direct economic losses caused by pollution in agricultural lands, which 
leads to reduced grain production and raises public questions of food 
safety. Few NGOs have focused on soil quality and food safety; so 
shining a light on this area could help raise this issue's profile on 
the policy agenda. Thanks to the latest round of discussion on and off 
line about China's soil pollution, the country is now expecting a new 
oil pollution prevention and control law in three years.\4\
   taking it to the streets--protest as participation of last resort
    The Chinese Public Security Bureau no longer publishes the exact 
numbers on environmental pollution protests, but in a recent lecture on 
the social impact of pollution problems organized by the Standing 
Committee of the National People's Congress, Yang Chaofei, the vice-
chairman of the Chinese Society for Environmental Sciences, stated that 
the number of environmental mass incidents has grown an average of 29 
percent annually from 1996 to 2011.\5\ Yang noted particularly that 
pollution incidents involving dangerous chemicals and heavy metal 
pollution have risen since 2010. Chinese news media frequently report 
on protests, particularly urbanites whose protests against polluting 
factories have led to closures and sometimes halted planned projects. 
For example, earlier this year when an environmental activist in 
Kunming learned about plans for constructing a refinery and 
petrochemicals base near Kunming to process oil from Myanmar, he 
started disseminating leaflets condemning the planned project. His 
efforts ultimately sparked a major protest in the city on May 17, 2013, 
which prompted Kunming's mayor to meet with the protestors and promise 
the local government would take their opinions into account in the 
city's ruling on the project.
    While the growing number of pollution protests indicates a 
citizenry keen on demanding their right to a clean environment, many 
protests are ultimately more a symptom of China's environmental 
governance problem and will not, at least in the near term, solve the 
nation's pollutions. If, for example, the Chinese public was actively 
involved in environmental impact assessment hearings (as is required by 
law) many protests could have been avoided. Without a formal channel to 
learn of large infrastructure projects such as construction of 
incineration plants and oil refineries, the public is left with little 
choice but to protest when they learn about the project. Another 
weakness of protests is that the often ``Not In My Backyard (NIMBY)'' 
protests do not stop polluting behavior, but simply move it. There are 
numerous examples of dirty factories which face campaigns online and on 
the streets in east coast urbanities simply move the set-up to a poorer 
inland community where the cycle of pollution and protest may begin 
again. This, most notably, occurred after the 2007 PX protests in the 
city of Xiamen where city authorities moved a planned PX facility 30 
miles inland.\6\
                 potential of public interest law cases
    November 13, 2005 witnessed one of the biggest environmental 
disasters in China's modern history. An explosion occurred at a 
PetroChina chemical plant in China's northwestern Jilin Province, 
spilling 100 tons of benzene into the Songhua River and creating a 
toxic slick stretching over 80 kilometers into the Amur River in 
Russia. On behalf of the endangered species and the polluted river, a 
group of Chinese lawyers filed a lawsuit against the subsidiary of 
PetroChina responsible for the spill, inaugurating a new era in Chinese 
environmental activism: seeking legal recourse for environmental harm 
through a public interest case. Though the court eventually dismissed 
the Songhua River Case, because it did not recognize animals and 
ecosystems having legal standing as plaintiffs, the case sparked a 
legal and policy discussion about how such cases could become a 
valuable tool to strengthen China's poor enforcement of pollution 
control laws and regulations. In August 2012, Article 55 of China's 
Civil Procedure Law was amended to create effective space for 
environmental public interest litigation that might have even allowed 
for the Songhua River case to receive standing.
    The amendments to Article 55 of China's Civil Procedure Law grant 
the right to statutorily approved authorities and relevant 
organizations to initiate lawsuits against polluters on behalf of the 
public interest. In other words, the plaintiff does not need to show 
personal injury or loss from the pollution. This is the first time a 
Chinese national law recognizes public interest litigation. Another 
notable amendment, to China's Civil Procedure Law, allows non-judicial 
experts to challenge the opinion of judicial appraisers and aid Chinese 
court in fact finding, a move that opens up the court to new 
stakeholders. Because there are a limited number of judicial appraisers 
(judicial experts) in China, allowing non-judicial experts for 
testimony will effectively widen the pool to environmental experts and 
potentially increase the speed of the cases.
    In 2011 two independent Chinese NGOs--Friends of Nature and 
Chongqing Green Volunteer Association--tested the public interest law 
by bringing a public interest law case against a mining company that 
illegally dumped 5,000 tons of chromium tailings next to a reservoir in 
western Yunnan. The toxic runoff severely contaminated the water and 
killed livestock and crops in nearby villages.\7\
    Chinese courts often shun large pollution cases, yet the Yunnan 
court accepted the NGO plaintiffs in this case because of a provincial 
law that granted the NGOs' legal standing. The local environmental 
protection bureau also joined as a plaintiff, which greatly facilitated 
the compiling of evidence. Moreover, the NGOs successfully catalyzed 
considerable news media reporting on the case. Wang Canfa, founder of 
the Center for Legal Assistance for Pollution Victims, was quoted 
saying that this case was a good start for the public interest lawsuits 
in China. He considered this case as helpful in shaping the Civil 
Procedure Law Amendments.\8\
    Robert Percival, a professor at University of Maryland Carey School 
of Law, explained at a November 29, 2012 meeting at the Woodrow Wilson 
Center that while China amended Article 55 of its Civil Procedure Law 
to allow for public interest suits, many questions still remain, 
particularly regarding precisely who can serve as a public interest 
plaintiff. Ultimately, the major challenge faced by those wishing to 
raise public interest suits is the courts' unwillingness to accept such 
cases, especially if the company in question serves as a major source 
of local tax revenue.
    These new rules under Article 55 are encouraging developments that 
indicate a growing space for public interest law and greater 
involvement of NGOs in environmental advocacy. However, the Article 55 
rules have yet to be tested in a large high profile case and will 
likely need more guidance from either the legislators or the courts to 
be fully applied. There are currently six to ten public interest 
environmental law cases that NGOs and lawyers are working on in China, 
which indicates an appetite to experiment with this new tool.
    The smoggy air devouring Beijing is one prominent example of how 40 
years of double-digit economic growth has exacted a huge environmental 
cost on China. The Chinese government's own data highlight the growing 
costs: the Chinese Academy of Environmental Planning (a research 
institute under the Ministry of Environmental Protection) reported in 
March 2013 that environmental degradation cost the country about $230 
billion in 2010, or 3.5 percent of China's GDP. This is three times 
higher than MEP's estimate of pollution costs in 2004.\9\ The growing 
costs of environmental degradation and the government's own inability 
to enforce existing laws will be one of the greatest challenges for 
China moving forward.
    It is important for China to keep opening political space that 
allows grassroots groups, lawyers, and the general public to push for 
transparency, open information and public interest law cases, for these 
tools can create effective pressure for better environmental 
performance by the government and industry. However, in the long run 
there are many vital political reforms that China must make to truly 
strengthen environmental enforcement--such as creating a completely 
independent judiciary and empowering the Ministry of Environmental 
Protection. Alex Wang, a UC Berkeley researcher, argues that to 
substantially improve environmental performance by local governments 
China needs to establish hard targets for environmental quality 
outcomes against which officials at the province and sub-provincial 
levels are held strictly accountable.\10\
    Pressing pollution problems that threaten China's economy have 
motivated Chinese policymakers to explore creative reforms in pollution 
control, clean energy laws, and regulations. Such experimentation has 
made environmental protection one of the most progressive policy and 
legal advocacy areas in China, particularly in terms of prioritizing 
open information, encouraging public participation, creating and 
setting up special courts, and granting political space for NGOs. Many 
international groups have conducted research and pilot projects that 
have helped build the capacity of Chinese regulators, NGOs, and 
researchers to develop these bottom-up regulatory tools. Of relevance 
for today's testimony, the U.S. EPA, Vermont Law School, Natural 
Resources Defense Council, American Bar Association, and other NGOs 
have been active in creating exchanges and conducting trainings in 
environmental information transparency, public participation, and 
public interest law. Such work strengthens China's environmental 
governance, which could help reduce pollution, better protect the 
health of Chinese citizens, and the products they consume. Cleaner 
skies over China also could lower the growing problem of air pollution 
from China impacting neighboring countries and the western coast of the 
United States.
    Additionally, as the Chinese government improves environmental 
governance regulations and encourages stronger public and government 
watchdogs, Chinese companies will come under greater pressure to obey 
pollution control laws. Forcing Chinese companies to internalize the 
costs of pollution could raise the cost of products produced in China 
and potentially help level the playing field with international 
companies that have already been doing a better job in pollution 
                             * * * * * * *

    \1\ Xinhua. (2013, January 1). ``74 Chinese cities release real-
time PM2.5 data.'' China Daily. http://www.chinadaily.com.cn/china/
    \2\ Brian Spegele. (2013, May 17). ``Behind Chinese Protests, 
Growing Dismay at Pollution.'' The Wall Street Journal.
    \3\ Survey: Govt needs to focus more on environment http://
    \4\ Caijing. (2013, May 27). ``China will issue soil pollution 
prevention law within 3 years.'' http://www.cfen.com.cn/web/meyw/2013-
    \5\ Jennifer Duggan. (2013, 16 May). ``Kunming pollution protest is 
tip of rising Chinese environmental activism.'' The Guardian. http://
    \6\ Brian Spegel. (2013, May 17).
    \7\ Story of illegally dumped chromium in China wins environmental 
press award. http://www.guardian.co.uk/environment/2012/apr/11/
    \8\ Xinhua. (2012, May 24). ``Lawsuit demands 10 mln yuan for 
pollution victims.'' China.org.cn.http://www.china.org.cn/environment/
    \9\ Edward Wong. (2013, March 29). ``Cost of Environmental Damage 
in China Growing Rapidly Amid Industrialization.'' The New York Times. 
    \10\ Alex Wang. (February 8, 2013). ``Airpocolypse Now: China's 
Tipping Point?'' Green Leap Forward. www.greenlapforward.com/2013/02/

                  Prepared Statement of Yanzhong Huang

                              may 22, 2013

          Coping with Public Health Hazards in Post-SARS China

    In the past decade, multiple disease outbreaks have emerged in 
China, including the SARS epidemic in 2002 to 2003, the H5N1 (``bird 
flu'') outbreak in 2005 to 2006, the hand, food and mouth disease 
(HFMD) outbreak in 2008, and the H1N1 (``swine flu'') pandemic in 2009. 
In the spring of 2013, the emergence of a new strain of bird flu (H7N9) 
in China has once again raised global concern over pandemic risks. As 
of May 17, a total of 131 laboratory-confirmed H7N9 cases and 36 deaths 
had been reported in at least 10 provinces/municipalities.\1\
    Additionally, in recent months, the concern over environmentally-
driven public health hazards in China has grown. The off-the-chart 
level of PM2.5--the most harmful types of toxic smog--in north China in 
January, the reports of the existence of nearly 400 ``cancer villages'' 
--areas where pollution has contributed to unusually high rates of 
cancer--in February, and the discovery of about 20,000 pigs floating 
down Huangpu River in Shanghai in March all prove how the public 
awareness (and the severity) of these environmental-health concerns are 
                   improving government transparency
    In addressing the H7N9 outbreak, the Chinese government has, 
overall, been quite transparent. The health authorities updated 
information on the infection cases and fatalities on a regular and 
timely basis, and the National Health and Family Planning Commission 
(NHFPC), the successor to the Ministry of Health, also shared 
information about the disease with Taiwan, Hong Kong, the World Health 
Organization (WHO) as well as the U.S. Centers for Disease Control and 
Prevention (CDC). The central and local health authorities quickly 
unveiled plans involving medical and non-medical interventions to 
contain the spread of the virus. The government also acted promptly to 
calm speculation about the possible linkage between H7N9 and the dead 
pigs in Shanghai. While questions were raised on why it took three 
weeks for the health authorities to publicize the first cases, it 
appears that this had more to do with the difficulties of isolating a 
novel strain of the virus rather than being a deliberate cover-up.
    The government openness and transparency over H7N9 prevention and 
control has been accompanied by increased cooperation with the 
international community. Within a week of the outbreak, China shipped 
the virus samples to WHO reference laboratories for proper 
identification and development of vaccines. The NHFPC also invited WHO 
experts to visit areas affected by the virus. The H7N9 samples sent 
from China enabled the U.S. CDC to develop diagnostic kits and a 
vaccine for the virus in case it spread to America. As noted by a 
senior CDC official, the information exchange with China has been 
``almost in real time.'' \2\ Indeed, since SARS, the U.S. CDC has been 
in regular contact with its Chinese counterparts.
    The improving government transparency in the H7N9 outbreak is in 
sharp contrast to its response in the initial stage of the 2003 SARS 
epidemic, which was characterized by cover up and inaction.\3\ It is, 
of course, not the first time since the SARS crisis that the government 
is forthcoming about public health hazards. Drawing on lessons learned 
in the SARS debacle and driven by the revised International Health 
Regulations or IHR (2005), China has made tremendous investments in 
building core capacities to detect, assess, notify, and respond to 
public health emergencies. It has managed to construct the largest 
infectious disease surveillance and reporting system in the world and 
put in place a legal framework that aims to release disease-related 
information in a timely, accurate, and comprehensive manner. During the 
2009 H1N1 pandemic, for example, the government swung into action from 
the very onset of the virus, and health authorities drummed up 
awareness of the dangers of the virus to make sure all intervention 
measures were widely broadcast and updates about the disease were 
regularly disseminated. The efforts to create a more open and 
transparent image can also be identified in areas beyond addressing 
public health emergencies. In January 2013, China began to release 
real-time, online data on PM2.5 in 74 major cities, and in the 
following month, admitted to the existence of ``cancer villages.'' This 
was considered a small but significant step because up until very 
recently, the Chinese government avoided making a connection between 
pollution and disease.
             is the move toward transparency irreversible?
    The move toward growing transparency is by no means a linear or 
irreversible one. As indicated in Anhui province's handling of HFMD in 
2008 and Shanghai's efforts to identify the causative agent of H7N9, 
most localities in China still do not have the capability to correctly 
and swiftly identify emerging infectious diseases. Critical central-
local gaps in epidemiological and laboratory capacities, when coupled 
with an authoritarian political structure, may contribute to sustained 
cover-up, underreporting, or misreporting at the sub-national level. 
Moreover, as health is increasingly viewed as a ``high politics'' issue 
on government agenda, government response to public health emergencies 
can be hijacked by domestic political deliberations. As the 20th 
Anniversary of the Tiananmen crackdown (June 4) and the 60th 
anniversary of the founding of PRC (October 1) were around the corner 
during the 2009 H1N1 pandemic, for example, social-political stability 
became the dominant concern of government leaders, which led to 
lingering cover-up, underreporting, and delayed reporting of cases and 
    But in the meantime, technological revolution and the revised IHR 
have generated additional incentives for openness and transparency in 
coping with public health hazards in China. The Internet-based disease 
reporting system launched in the wake of SARS, for example, has enabled 
hospitals and township health centers to directly report suspected 
disease outbreaks to central health authorities. Furthermore, the 
revised IHR, by legitimizing the role of non-state actors in disease 
reporting, have broadened the space of disease surveillance beyond the 
duty of the sovereign states.
                       the role of civil society
    To be sure, the government today continues to impose various 
constraints on civil society's engagement in surveillance and response 
capacity building. Not only does the number and size of health-related 
NGOs in China remain small, but vast majority of them are heavily 
dependent upon international donors for support. Few NGOs work on 
addressing public health emergencies and most of them are focused on 
HIV/AIDS prevention and control. As the 2008 HFMD outbreak and the 2009 
H1N1 pandemic have demonstrated, in the absence of effective NGO 
participation in risk communication and policy implementation, upward 
and downward information flows could be hindered, and the state could 
have too much leeway to violate the privacy and human rights of its 
citizens when responding to public health emergencies.\5\
    That said, a civil society facilitated by the spread of social 
media is increasingly having its voices heard and its action felt in 
China's policy process. To the extent that short text messages were 
widely used by the Chinese during the SARS epidemic to exchange disease 
related information, during the H7N9 outbreak Chinese people have 
increasingly turned to microblogs or Weibo for receiving and spreading 
such information. Popular posts written by leading public intellectuals 
such as Li Chengpeng and entrepreneurs such as Ma Yun can potentially 
force the Chinese government to take public health-related concerns and 
criticisms more seriously. But such ``online vigilantism'' also runs 
the risk of taking on a life of its own by ``reaching a foregone 
conclusion without the benefit of a full investigation,'' \6\ which may 
not lead to effective, accurate risk communication. In the H7N9 
outbreaks, for instance, the almost real-time disease alerts through 
social media and mainstream media outlets sent mixed signals on the 
nature of the virus in question. Also, the narrowing of time for 
response and alert could compromise government capacity to undertake 
effective measures for disease containment. Eager to come up with 
solutions to calm an anxious public, the government treatment and 
prevention guides advised the use of traditional medicines even though 
their effectiveness remained unknown and some had been found to cause 
serious adverse reactions.
  how can the united states promote transparency and openness in china
    Despite its opaque and often exclusive policy process, global 
players and norms do have a role to play in China's domestic health 
governance.\7\ Given the potential economic, social-political, even 
security implications of infectious disease outbreaks, it is in the 
interest of both the United States and China to collaborate closely in 
building disease surveillance and response capacities in China. As a 
global health leader, the United States should continue encouraging 
China to promote transparency and openness. In addition to cooperating 
with central health authorities in China, the U.S. CDC should consider 
shifting more resources to improve surveillance capacity at the 
subnational level. Also, while the United States should continue to 
provide financial and technical support to health-related NGOs in 
China, more attention and resources should be given to cultivating 
civil society groups that promote awareness, transparency and capacity 
building in addressing public health emergencies. Through deft use of 
social media, the United States could also play a critical role in 
elevating some ``latent'' public health problems (e.g., cancer 
villages) on the governmental agenda. In 2008, the U.S. Embassy began 
to monitor Beijing's air quality level using a devise atop its 
building. By following the Embassy's Twitter feed, Beijing residents 
became aware how serious the problem was. The growing awareness forced 
the Chinese government to become more transparent on the issue of air 
pollution. It began releasing figures on PM2.5 in early 2012.
                             * * * * * * *
    \1\ World Health Organization, Human infection with avian influenza 
A(H7N9) virus - update, May 17, 2013, at http://www.who.int/csr/don/
    \2\ Christina Larson, ``CDC Races to Create a Vaccine for China's 
Latest Bird Flu Strain,'' BusinessWeek, April 10, 2013, at 
    \3\ Yanzhong Huang, ``Implications of SARS Epidemic for China's 
Public Health Infrastructure and Political System,'' Testimony before 
the Congressional-Executive Commission on China Roundtable on SARS, May 
12, 2003.
    \4\ Yanzhong Huang, Governing Health in Contemporary China (London 
and New York: Routledge, 2013), esp. chapter 4.
    \5\ Ibid.
    \6\ ``Why Is a 1995 Poisoning Case the Top Topic on Chinese Social 
Media?'' A ChinaFile Coversation, May 7, 2013. Available at http://
    \7\ Yanzhong Huang, ``China and Global Health Governance,'' Indiana 
University Research Center for Chinese Politics & Business, Working 
Paper #26, May 2012.

                    Prepared Statement of Tony Corbo

                              may 22, 2013
    Chairman Brown, Co-Chairman Smith and members of the Commission. My 
name is Tony Corbo, and I am the Sr. Lobbyist for the Food Program at 
Food & Water Watch, a nonprofit consumer advocacy organization. We were 
founded in November 2005 and our mission is to ensure that our food, 
water and fish are safe, accessible and sustainably produced. We 
currently represent some 500,000 members and supporters. Thank you for 
the opportunity to present testimony on this important topic.
    The United States is increasingly reliant on imported food. The 
U.S. Government Accountability Office (GAO) reports that from 2000 
through 2011, the percentage of food consumed in the United States that 
was imported rose from 9 percent to over 16 percent, and food imports 
increased by an average of 10 percent each year for seven years.\1\ 
According to the U.S. Department of Agriculture's (USDA) Economic 
Research Service, the food groups with the highest share of imports are 
fresh fish and shellfish (85 percent in 2009) and fruits and nuts (38 
percent in 2009).\2\
    China is a growing supplier of the United States' food imports. 
China is the largest agricultural economy in the world and one of the 
biggest agricultural exporters.\3\ It is the world's leading producer 
of many foods Americans eat: apples, tomatoes, peaches, potatoes, 
garlic, sweet potatoes, pears, peas--the list goes on and on.\4\ It is 
also a leading producer of many of the inputs used to make processed 
food, for example ascorbic acid, or vitamin C, producing about 80 
percent of the world supply.\5\
    But the poorly controlled expansion of China's economy has often 
been fueled by excess pollution, treacherous working conditions, and 
dangerous foods and products that pose significant risks to consumers 
in China and worldwide. China's food manufacturers often found to cut 
corners and substitute dangerous ingredients to boost sales.
    Food safety problems in China have been making headlines around the 
world for quite a while, especially after several rounds of publicity 
concerning contamination of foods with a chemical, normally used to 
make plastic, called melamine. The chemical has been intentionally 
added to different food products in China, usually to try to 
artificially increase the nitrogen content in attempt to pass tests for 
protein levels.
    In 2007, the U.S. Food and Drug Administration (FDA) received 
reports of 17,000 pet illnesses, including 4,000 dog and cat deaths, 
believed to be the result of melamine contamination in imported Chinese 
gluten used to make pet food.\6\ Sixty million packages of pet food 
were recalled in the United States.\7\ The potential health impacts 
were not necessarily limited to pet food, however, because some of the 
melamine-contaminated pet food was redirected to hog farms. Thousands 
of hogs that ate the contaminated food were put to death in an effort 
to keep melamine-contaminated meat from entering the food supply.\8\ 
But the FDA and USDA still allowed 56,000 hogs that ate melamine-
tainted pet food to be processed into pork, which was then sold at 
    By 2008, the FDA had identified melamine in imported wheat gluten 
and rice protein from China (used in pet food), prompting rejections of 
44 percent and 32 percent of these products, respectively.\10\ While 
the FDA stopped these shipments, pet food imports from China continued 
to rise and reached 79 million pounds in 2010.\11\
    Pet food turned out to be only the tip of the melamine iceberg. 
Because melamine was widely used in China to adulterate dairy products 
such as milk powder, processed food products including candy, hot 
cocoa, flavored drinks and, most tragically, infant formula contained 
the chemical.\12\ An infant formula scandal erupted just before the 
2008 Beijing Olympics and ultimately an estimated 300,000 infants and 
children in China were sickened by melamine; more than 12,000 were 
hospitalized.\13\ At least six children died.\14\
    Melamine-tainted milk was also exported worldwide. The New Zealand-
based food company Fonterra became caught up in the melamine scandal 
through a joint venture with the Chinese dairy company Sanlu that was 
implicated in the melamine crisis.\15\ The scandal played out across 
the globe, ending up in the food supplies of companies including Mars, 
Unilever, Heinz, Cadbury and Yum! Brands, Inc. (which owns Pizza Hut, 
KFC, Taco Bell and other fast food chains).\16\
    While the melamine crisis may be the most widely covered Chinese 
food safety scandal, unfortunately it was not an isolated incident. 
International media sources routinely cover food safety problems 
originating in China, ranging from widespread smuggling of products 
like honey to avoid tariffs and food safety restrictions,\17\ 
mislabeled products ``transshipped'' through another country but 
produced in China,\18\ and importing countries discovering violations 
of pesticide or other food safety regulations.
    A 2013 report by a food industry analyst found that among reported 
food violations in Chinese products, the most frequent cause was 
pesticides, followed by pathogen contamination. The report cited 32 
pesticides found in laboratory testing of Chinese foods, mostly in 
produce, fruit and spices and noted that ``economically motivated 
adulteration'' is a persistent issue in food production in China.\19\
    These food safety problems have not gone unnoticed by consumers in 
the United States or China. After more than a decade of increased food 
imports from China, U.S. consumers are extremely wary, with one 2011 
poll revealing that participants picked China 81 percent of the time 
when asked to choose two countries they perceived as having the least 
food safety oversight.\20\ Chinese consumers are not much more 
confident about their domestic food supply. A 2011 survey found that 
food safety is a major concern for almost 70 percent of Chinese 
consumers \21\ and there are regular reports of Chinese tourists 
emptying store shelves in other countries in search of infant formula 
not produced in China.
    One tool that U.S. consumers do have is labeling. Thanks to federal 
labeling requirements, country of origin labeling is required for beef, 
pork, lamb, chicken, goat meat, wild and farm-raised fish and 
shellfish, perishable agricultural commodities (fruits and vegetables), 
peanuts, pecans, ginseng, and macadamia nuts. But these labeling rules 
do not apply to processed forms of these foods, and the USDA's 
definition of processing is far too broad, which excludes many foods 
from the labeling requirement. The U.S. rules for labeling meat have 
also been challenged at the World Trade Organization (WTO), resulting 
in a process of revising the rules that is ongoing.
                      u.s. food imports from china
    After joining the World Trade Organization in 2001, China's food 
exports to the United States tripled to 4.1 billion pounds of food in 
2012.\22\ In addition to Chinese firms exporting to the United States, 
U.S. food and agribusiness companies have capitalized on China's cheap 
labor costs and weak regulations, hoping to sell to a growing class of 
Chinese consumers and export to the United States.
    Total U.S. food imports from China fell during the economic 
recession, but over the past four years, imports have increased by 
about 250 million pounds, a 7 percent increase from 2009 to 2012.\23\ 
Fruits and vegetables (primarily frozen and processed) make up most of 
the U.S. imports from China, amounting to 1.6 billion pounds and 41 
percent of imported food products. 1.2 billion pounds of fresh, frozen 
and processed fish and seafood products made up about a third of 
imports (30 percent).\24\
    Most Chinese exports to the United States are fruits and vegetables 
that can be harvested and processed with lower labor costs in China 
than elsewhere,\25\ undercutting U.S. farmers. As the world's largest 
apple producer, for example, China's apple juice concentrate exports 
supply a growing share of America's apple juice. By 2007, half the 
garlic Americans ate was grown in China, although that figure fell to 
31 percent in 2011 as the recession and falling dollar dampened import 
demand.\26\ Before China entered the WTO, the United States produced 
about 70 percent of the garlic Americans consumed.\27\ Over the past 
decade, imports of Chinese garlic more than quadrupled, while U.S. 
garlic cultivation dropped by a third.\28\
    The millions of pounds of imports from China represent a 
considerable portion of the food eaten by U.S. consumers. For example, 
in 2011:

         Eighty percent of the tilapia Americans ate came from 
        the 382.2 million pounds of imports from China.
         The United States imported 367 million gallons of 
        apple juice from China, amounting to almost half (49.6 percent) 
        of U.S. consumption.
         The 70.7 million pounds of cod imported from China 
        amounted to just more than half (51 percent) of U.S. 
         The 217.5 million pounds of imported garlic was 31.3 
        percent of U.S. consumption.
         The 39.3 million pounds of frozen spinach represented 
        11 percent of U.S. consumption. (For more import quantities, 
        see chart in Appendix I.)

    Other Chinese exports include processed foods and food ingredients, 
products which most consumers purchase without considering where they 
came from. China is a leading supplier to the United States of 
ingredients like xylitol, used as a sweetener in candy, and sorbic 
acid, a preservative.\29\ China supplies around 85 percent of U.S. 
imports of artificial vanilla, as well as many vitamins that are 
frequently added to food products, like folic acid and thiamine.\30\ By 
2007, 90 percent of America's vitamin C supplements came from China, 
and by 2010, China supplied the United States with 88 million pounds of 
candy.\31\ The United States also imported 102 million pounds of 
sauces, including soy sauce; 81 million pounds of spices; 79 million 
pounds of dog and cat food; and 41 million pounds of pasta and baked 
goods from China in 2010.\32\
                u.s. regulation of chinese food imports
    U.S. oversight of Chinese food processors has not remotely kept 
pace with the growth in imports. Though the Food and Drug 
Administration prevented 9,000 unsafe Chinese products from entering 
the country between 2006 and 2010,\33\ it is not because of vigilant 
inspection at U.S. borders and ports. The agency's low inspection 
rate--less than 2 percent of imported produce, processed food and 
seafood \34\--almost guarantees that unsafe Chinese products are making 
their way into American grocery stores.
    Other importers of food from China have instituted more intensive 
testing regimes for Chinese imports. From 2004 to 2009, Japan tested 
between 15 and 18 percent of food products from China, and up to 38 
percent of frozen vegetables.\35\
    In 2007, the FDA's director of the Center for Food Safety and 
Applied Nutrition stated that the growing Chinese food exports have 
``outstretched and outgrown the regulatory system for imports in the 
U.S.'' \36\ During the melamine-tainted pet food crisis, it took the 
FDA one month to even identify their regulatory counterparts in 
    In 2007, China consented to allow FDA inspectors to be stationed in 
China, and the FDA opened its first office in 2008.\38\ However, the 
few FDA inspectors in China were overwhelmed by the sheer size of the 
nations's food production, including an estimated 1 million food-
processing companies.\39\ Between 2001 and 2008, the FDA inspected 46 
food firms in China--less than six a year.\40\ After the spate of 
import scandals, the FDA increased inspections, but still only 
conducted 13 food inspections in China from June 2009 to June 2010.\41\ 
In fiscal year 2012, FDA conducted 10 inspections of food facilities in 
China.\42\ Recently, the agency instituted a sampling program for 
Salmonella for pet food, pet treats and pet nutritional supplements, 
but only for domestic products.\43\ The new testing program does not 
cover imports, despite the large volume and troubled safety record of 
pet food and treats imported from China.
    Meat and poultry imports are the responsibility of the U.S. 
Department of Agriculture. Until 2009, FSIS conducted in-depth annual 
on-site audits of countries eligible to export meat, poultry and egg 
products to the United States. The department recently announced that 
in 2009 it made a major change to this system by ending annual visits 
to exporting countries, and instead starting to rely on a ``Self-
Reporting Tool'' for countries as a substitute to annual audit visits. 
With this change, USDA began conducting audit visits every three years 
instead of annually and the agency stopped the practice of publishing 
the audit results of individual foreign meat, poultry, egg plants that 
exported products to the United States. This weakening of oversight of 
foreign meat and poultry producers does not yet impact products from 
China, because the country has not yet been approved to ship these 
products to the United States. But China is in the process of being 
certified ``equivalent'' to U.S. meat inspection standards and 
therefore eligible to export products.
    The USDA's actions with regard to China's interest in exporting 
poultry products to the United States offers a telling example of how 
the pressure to increase trade can leave food safety concerns as a 
lower priority. Currently, the United States does not permit poultry 
imports from China. U.S. agribusinesses have invested heavily in 
Chinese chicken production and processing--both to feed Chinese 
consumers and as a future export platform to U.S. consumers--and they 
have been working to get USDA approval for Chinese poultry exports to 
the United States.
    In 2006, the USDA rapidly finalized China's request to begin 
exporting processed chicken to the United States the very same day as a 
visit from China's president.\44\ This action apparently prompted China 
to resume negotiations over lifting its ban on American beef, 
instituted in 2003 after the discovery of mad cow disease in the state 
of Washington.\45\
    Despite the Bush Administration's public blessing of Chinese 
chicken, the USDA's internal inspection reports of Chinese poultry 
facilities showed egregious food safety problems, including mishandling 
raw chicken throughout the processing areas, failing to perform E. coli 
and Salmonella testing, and routinely using dirty tools and 
equipment.\46\ As these internal reports emerged, Congress refused to 
implement the Bush Administration proposal, effectively maintaining a 
ban on Chinese poultry imports.\47\
    China contended the U.S. prohibition against chicken, produced in 
unsafe plants with insufficient inspection, was an illegal trade 
barrier. The World Trade Organization agreed in September 2010.\48\ The 
same month, China announced it would impose high tariffs on American 
chicken products for allegedly being priced too cheaply.\49\
    In January 2011, Chinese President Hu Jintao again visited the 
United States, cementing tens of billion of dollars in trade deals with 
the Obama Administration.\50\ Shortly after this visit, the USDA 
announced new steps it had taken to honor China's request to export 
chicken to the United States.\51\
    Currently, the USDA's Food Safety and Inspection Service is working 
through the steps to approve China as an exporter of poultry products 
to the United States, with the next step in the approval process 
expected to be completed in the fall. This process continues to 
proceed, even as the poultry sector in China is suffering mounting 
economic damage from a growing avian influenza outbreak.\52\
    The processed poultry products being considered for approval are 
supposed to be made in Chinese plants from birds that have been sent 
from ``approved'' sources, including the United States or Canada, but 
not China. But without stationing USDA inspectors in Chinese processing 
plants, it will be virtually impossible to verify that these products 
are made from birds from approved sources rather than Chinese 
                 organic and third party certification
    Organic products from China have not been immune from food safety 
concerns. Organic beans and berries imported from China have been 
rejected by the FDA for high pesticide levels, despite the fact that 
synthetic pesticides are not allowed under the USDA organic label.\53\ 
More recently, testing conducted by U.S. media outlets found pesticide 
contamination of an organic ginger product sold in the United 
    According to USDA's National Organic Program, from 1995 to 2006, 
the value of organic food exported from China rose from $300,000 to 
$350 million and vegetables, field crops and tea were China's largest 
organic exports.\55\ In 2006, there were 496 operations in China 
certified as meeting U.S. organic standards and by 2010 that number had 
risen to 649 operations.\56\
    In the United States, the USDA sets organic standards and third 
party certifiers are responsible for inspecting farms and food 
processors to ensure they are meeting the standards. In 2010, the USDA 
visited China to conduct an audit of four of the ten certifiers 
operating there. The agency reported that conditions ``pose challenging 
oversight duties and responsibilities for certifying agents operating 
in China. Additionally, the size of China's land mass and higher 
financial margins in the organic industry could pose potential for 
fraud, especially by those outside of the organic certification 
system.'' \57\
    In 2010, USDA banned one of the third party certifiers operating in 
China because the organization used Chinese government employees to 
inspect state-controlled farms.\58\ But the challenge of operating 
truly independent third party auditing or inspection operations in 
China is not isolated to organic certification.
    The FDA Food Safety Modernization Act, which became law in January 
2011, instructs the FDA to establish a reliable system of audits 
conducted by foreign governments or other third parties for imported 
foods. A 2012 GAO report outlines the significant obstacles to doing 
this.\59\ FDA has struggled in the past to oversee inspection 
activities conducted on contract to the agency by state 
governments,\60\ a task that should be much simpler than coordinating 
with third parties and foreign governments around the world. To build 
the infrastructure and IT system necessary to oversee third party 
certifiers in countries such as China, where third parties and even 
government agencies must be accredited by another government 
agency,\61\ seems like it will be an extraordinarily challenging 
project for the agency.
                       china's food safety system
    Chinese officials have readily acknowledged the country's food 
system as ``grim.'' \62\ The country's decentralized and overlapping 
regulatory system has not been able to address China's sprawling food-
processing industry. Repeated government efforts to reform food safety 
rules have so far failed to stem the tide of adulterated food. After a 
major food safety law from 2009 went into effect, a professor at the 
Chinese Academy of Governance stated that poor coordination between 
agencies, lackluster enforcement and inadequate government oversight 
hindered the enforcement of food safety laws.\63\ It remains to be seen 
if an overhaul of the food safety system, announced in 2012, will 
manage to coordinate efforts government-wide and tighten food safety 
    The situation for Chinese consumers can be more dire than what U.S. 
and other export customers face. China usually exports the highest-
quality food the country produces, leaving Chinese consumers vulnerable 
to the lower-quality products that remain.\65\
    Reports on food safety problems since 2009 yield a long list of 
problems in both the domestic food supply and exported products. One 
persistent trend is ``economically motivated adulteration,'' or what 
has been described as a culture of adulteration in China's agricultural 
sector.\66\ Melamine contamination in Chinese food continues to be a 
problem, with a crackdown on melamine in milk powder in 2010 resulting 
in 96 arrests and 26 public officials being fired \67\ and U.S. 
regulators finding high levels of melamine in a dog food shipment in 
January 2011.\68\ After increased attention to the problem of melamine, 
some Chinese dairy producers appear to have switched to a new protein 
adulterant that is even more difficult to detect--hydrolyzed leather 
protein made from scraps of animal skin.\69\
    Even veterinary drugs banned in China--such as clenbuterol, 
administered to animals to give them leaner meat and pinker skin--
remain widely used in China despite years of documented consumer 
illnesses from residues in meat and organs,\70\ and controversies over 
athletes avoiding meat for fear of testing positive for the performance 
enhancing drug.
    Honey from China has continued to be a source of controversy. 
Illegal antibiotics are commonly found in Chinese honey imports. China 
dominates the international honey market and became the largest U.S. 
honey source after joining the WTO, supplying more than 70 million 
pounds by 2006.\71\ For years, regulators had closely scrutinized 
Chinese honey for drug residues, including one that can be fatal.\72\ 
In 2010, the FDA seized large amounts of Chinese honey after finding 
illegal antibiotics.\73\
    Another trend is pesticide residues that remain on fruit, 
vegetables and processed foods when they enter the food supply. China 
is the world's largest pesticide producer and exporter.\74\ In 2010, 
Chinese authorities found a banned, highly toxic pesticide in cowpeas, 
a legume similar to black-eyed peas.\75\ China has largely failed to 
address illegal or dangerous chemical residues on food, evident in its 
weak maximum residue levels. The United States has established maximum 
residue levels (MRLs) for 77 pesticides used in garlic production and 
112 pesticides used in apples orchards; of these, China has only 2 and 
23 MRLs, respectively.\76\
    Since 2009, the Chinese government has made a point of making 
public displays of enforcing food safety rules, inspecting food 
facilities and punishing people connected with tainted food. News 
reports frequently reference millions of inspections of facilities and 
frequent ``crackdowns'' on particular products. A search of news 
reports reveals a variety of enforcement efforts:

         The scandal over melamine-contaminated infant formula 
        led to the execution of two people and prison terms for dairy 
        company executives.\77\
         In 2011, industry and commerce authorities reported 
        62,000 cases of substandard food, leading to 43,000 unlicensed 
        operations being shut down and 251 cases being sent to the 
        judicial system.\78\
         A 2011 crackdown on food safety violations resulted in 
        2,000 arrests and 4,900 businesses being closed.\79\
         The Chinese news agency Xinhua reported in June 2012 
        that authorities shut down 5,700 unlicensed food businesses and 
        discovered 15,000 cases of ``substandard food'' so far that 
         In early May 2013, news reports described a Chinese 
        government campaign to break up a fake meat operation, leading 
        to arrests of more than 900 people accused of passing off more 
        than $1 million of rat meat as mutton.\81\

    Ironically, the recent discovery of more than 7,000 dead pigs in 
the Huangpu River was actually described in some media reports as ``an 
encouraging step forward in Chinese public health,'' because it 
indicated that rather than sell diseased animals into the food supply, 
producers dumped them into the river instead.\82\
    But despite the concerted effort to show that the government is 
tough on food safety violators, problems persist. A small sample of 
recent food safety problems:

         In 2010, a scandal erupted over the use of food 
        coloring and bleach to plump up shriveled old peas so they 
        would appear fresh.\83\
         Authorities detected plasticizers, chemicals linked to 
        immune and reproductive system damage, in samples of a leading 
        brand of a common distilled white liquor.\84\
         Testing by Greenpeace of 18 varieties of tea found 
        that every sample contained at least three different kinds of 
        pesticides. 12 of the samples showed traces of banned 
         In September 2012, FDA refused 10 shipments of canned 
        mushrooms from China due to pesticide contamination, resulting 
        in the Chinese government halting exports of canned mushrooms 
        to the United States.\86\
         China Central Television reported in 2012 that testing 
        of preserved fruit from 16 different companies found excessive 
        pigments, bleaching agents and preservatives, as well as 
        incorrect expiration dates.\87\
         The Xinhua News Agency reported in 2012 that wholesale 
        vegetable dealers in Shandong province were found spraying 
        cabbages with formaldehyde, presumably to preserve them during 
        transport without refrigeration.\88\
         A 2012 report noted that fish vendors in Beijing were 
        using a chemical used for temporary dental fillings to 
        tranquilize fish during transport.\89\

    Another recurring theme is lack of transparency. China's food 
safety enforcement system lacks the transparency necessary to warn the 
public about dangerous products or deter dangerous food-processing 
practices. The USDA reports that the Chinese government zealously 
guards the food safety data it collects, making it difficult to 
impartially evaluate China's food safety performance.\90\ In 2010, some 
officials criticized regional authorities that publicized a widespread 
case of pesticide adulteration rather than obeying the ``unspoken 
rule'' of keeping food safety problems hidden from the public.\91\ The 
father of one child sickened by melamine-tainted milk powder was 
jailed, and eventually paroled, for his activism on the issue.\92\
    Lack of transparency is also evident in an ongoing problem with 
imported pet treats from China. Since 2007, thousands of American dogs 
have fallen ill or died after eating chicken jerky treats made in 
China. The FDA reports ``from 2003, when China first approached the 
USDA about poultry exports, to 2011, the volume of pet food exports 
(regulated by the FDA) to the United States from China has grown 85-
fold.'' \93\ In August 2012, four months after visiting Chinese 
processing plants that export pet treats to the United States, the FDA 
published inspection reports that revealed that the factories refused 
to allow U.S. inspectors to collect samples for independent 
analysis.\94\ Ultimately, testing done by the New York Department of 
Agriculture and Markets found contamination of some of the treats with 
residues of an undisclosed antibiotic, triggering voluntary recalls of 
the products by the manufacturer.\95\
                  imported pharmaceuticals from china
    While Food & Water Watch does not work on the safety of 
pharmaceuticals, we have been following some of the problems that have 
surfaced with the safety of imported drugs, particularly from China. In 
2011 testimony before the Senate Health, Education, Labor and Pensions 
Committee, the Government Accountability Office noted that the number 
of imported pharmaceuticals has more than doubled since 2002, with 
China and India leading that growth. FDA was only able to conduct 
inspections of a very small number of foreign drug facilities that 
export to the U.S.\96\ In 2007 and 2008, the FDA discovered that there 
was a large spike in the number of deaths of consumers who took the 
blood thinner heparin. Heparin is made from the intestines of pigs and 
because of the abundant supply of swine in China, it is the primary 
source for crude heparin for U.S. drug manufacturers.\97\ As a result 
of investigations conducted by the FDA and the Centers for Disease 
Control, it was discovered that some of the Chinese crude heparin was 
actually oversulfated chondroitin sulfate (OSCS). OSCS can easily be 
confused for heparin in routine product testing. OSCS does not confer 
the same medicinal benefits as heparin to patients who have to take the 
drug and it is a cheaper substance. The FDA estimates that as many as 
149 U.S. consumers died from the intentional economic adulteration of 
this drug.\98\ The Chinese government has never accepted responsibility 
for the contaminated heparin reaching our shores.
              u.s. policies to address unsafe food imports
    The WTO's Agreement on Agriculture has been a failure for farmers 
in the United States and has encouraged the growth of export platforms 
in places like China that benefit from low wages and weak regulatory 
standards, putting consumers around the world at risk. Congress and the 
Obama administration must revisit the current trade agenda to make 
public health, environmental standards and consumer safety the highest 
priorities when making decisions about trade policy. Specifically:

         The USDA should restart the process of determining if 
        China's poultry inspection system is equivalent to the U.S. 
        system and conduct an entirely new investigation before 
        allowing Chinese poultry products to be exported to the United 
         The USDA needs the resources to increase current 
        levels of inspection of imported meat and poultry. If Chinese 
        poultry products are approved for export to the United States, 
        the USDA should permanently assign inspection personnel to 
        China so that the exporting plants receive regular visits by 
        USDA inspectors.
         The FDA needs the resources to effectively inspect the 
        growing volume of food imports from China and other countries. 
        Congress and the Obama Administration must provide adequate 
        funding to the FDA to increase import inspections, and to 
        increase the rigor of those inspections to include testing for 
        pathogens and chemical, pesticide and drug residues, and to 
        increase inspection of processed food ingredients.
         The FDA needs the resources to conduct inspections in 
        food facilities in China, rather than relying on third-party 
        certifications of the safety practices used by exporting firms. 
        The use of third-party certifications in China has already been 
        shown to be questionable in the certification used for organic 
        products and in pilot projects on aquaculture conducted by the 
        FDA. This type of system should not be used as a substitute for 
        safety inspection by U.S. government inspectors.
         The USDA should close the loopholes in the current 
        country of origin labeling rules and expand them to processed 
        meats, fruits and vegetables. Congress should also require 
        mandatory country of origin labeling for foods not currently 
        covered by existing law, to require basic manufacturing 
        information about where, and by what company, processed foods 
        were produced.

    I would happy to answer any questions that you might have. Thank 
you, again, for inviting Food & Water Watch to contribute to this 
                                      U.S. Imports from China               Share of U.S. Consumption
---------------------------------       (Millions of Pounds)      ----------------------------------------------
                                 ---------------------------------                                       4-Year
          Food Product             2009    2010    2011     2012     2008     2009     2010     2011    Average
Tilapia                            288.3   349.5   318.5    382.2    73.2%    77.8%    78.7%    80.2%      77.5%
Apple Juice (Mil. Gall.)           451.4   463.7   342.0    367.0    69.0%    70.0%    72.3%    49.6%      65.2%
Cod                                 63.2    71.4    78.9     70.7    59.4%    50.0%    50.4%    51.0%      52.7%
Mushrooms, Processing               78.1    78.6    68.2     68,4    53.7%    42.7%    22.4%    17.8%      34.1%
Garlic, All Uses                   245.4   234.3   226.9    217.5    23.1%    22.8%    32.4%    31.3%      27.4%
Clams                               17.0    19.8    24.1     27.4     9.0%    12.7%    19.0%    23.5%      16.1%
Spinach, Frozen                     32.2    32.5    36.2     39.3    16.0%    21.5%    15.3%    11.0%      16.0%
Crab                                18.9    23.7    22.9     22.9    15.0%    10.4%    13.5%    14.3%      13.3%
Salmon                              71.4    88.1    86.4     72.7    10.8%    11.1%    14.4%    14.3%      12.7%
Peaches, Canned                     91.8   109.8    92.0     98.5    11.8%     9.1%     9.0%     8.1%       9.5%
Cauliflower, Processing             11.1     8.9     1.3      8.1    12.0%    14.6%     7.8%     0.9%       8.8%
Shrimp                              97.1   106.0    94.7     78.6     8.6%     7.8%     8.7%     7.3%       8.1%
Pineapples, Canned                  65.2    52.7    40.6     26.2     9.7%     8.7%     7.1%     5.8%       7.8%
Pears, Canned                       53.0    57.2    49.4     50.7     7.3%     7.0%     7.6%     8.1%       7.5%
Asparagus, Frozen                    1.4     1.1     0.8      0.2    10.7%    12.2%     3.4%     1.9%       7.1%
Catfish/Pangasius                   22.8    17.9    10.8      7.9     2.7%     1.6%    14.4%     5.6%       6.1%
Broccoli, Processed                 29.4    25.7    30,4     25.9     3.7%     4.9%     3.4%     3.7%       3.9%
Green Peas, Frozen                  16.6    20.4    10.3      5.7     4.2%     3.5%     4.2%     2.3%       3.5%
Cherries, Sweet, Canned              0.1     0.6     0.0      0.3     0.0%     1.9%     8.4%                3.4%
Onions, Dried                        5.5     4.3     2.8      3.1     5.9%     5.1%     0.9%     0.6%       3.1%
Apples, Canned                      32.4    18.7    17.4     31.9     2.5%     3.0%     1.8%     1.8%       2.3%
Canned Tuna                         18.6    17.6    40.7     52.5     0.0%     1.9%     2.1%     5.1%       2.3%
Pears, Fresh                        24.3    11.6    13.8     12.4     2.8%     2.5%     1.2%     1.5%       2.0%
Strawberries, Frozen                 7.1    10.8     9.1      5.7     1.2%     1.3%     0.0%     0.0%       0.6%
Mushroom, Fresh                     10.6    10.6    11.4     13.0     1.3%     1.4%     1.4%     1.4%       1.4%
Artichoke, All Uses                  3.5     2.1     2.4      1.4     1.6%     1.9%     0.5%     0.5%       1.1%
Sources: USDA FAS GATS database; USDA Economic Research Service. Vegetable and Melon Yearbook 2011 and Fruit and
  Tree Nut Outlook 2012; U.S. National Fisheries Institute. ``Top 10 Consumed Seafoods.'' 2012.


                             * * * * * * *


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initial equivalence audit carried out in China covering China's poultry 
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April 16, 2013.
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operating in China.'' Food Chemical News. June 21, 2010.
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NOP). ``2010 Organic Assessment of China.'' July 2011 at 3.
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    \61\ GAO (2012) at 19.
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Press. March 3, 2009.
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safety.'' Xinhua. February 25, 2010.
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News. June 18, 2012.
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safety Issues.'' Associated Press. May 23, 2007.
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IANS. January 13 2011.
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Recorded in OASIS for China. January 2011. Accessed March 2, 2011 with 
code 72BCT99.
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watching for toxic melamine and leather protein in milk.'' Associated 
Press. February 17, 2011.
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world, by commodity (quantity): China. Based on most recent data 
available, 2008. Accessed December 14, 2010.
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Schumer raises fuss.'' National Public Radio. June 11, 2010.
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pesticide consumption and pollution: with China as a focus.'' 
Proceedings of the International Academy of Ecology and Environmental 
Sciences. 2011. 1(2): 125-144.
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scandal.'' New York Times. March 2, 2010.
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Available at www.mrldatabase.com/. Accessed March 2011.
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Associated Press. September 16, 2010.
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January 10, 2012.
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Concerns Remain.'' Time. August 5, 2011.
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Mess.'' International Herald Tribune. June 21, 2012.
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million-dollar rat-meat ring.'' Reuters. May 3, 2013.
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Is Safe.'' New York Times. March 14, 2013.
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Daily, China. March 31, 2010.
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22, 2012.
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2012 at 1-2.
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formaldehyde.'' Associated Press. May 7, 2012.
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concerns.'' USDA Today. January 24, 2011.
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Treats.'' September 14, 2012. http://www.fda.gov/AnimalVeterinary/
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testing, reports show.'' NBCnews.com. August 22, 2012.
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January 9, 2013.
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Labor, and Pensions Committee. ``Drug Safety: FDA Faces Challenges 
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Member, House Energy and Commerce Committee, Food and Drug 
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  Prepared Statement of Hon. Sherrod Brown, a U.S. Senator From Ohio; 
         Chairman, Congressional-Executive Commission on China

                              may 22, 2013
    Thank you for attending this timely hearing. I'd like to thank the 
distinguished panelists for being here to help raise awareness about 
this important topic.
    I'd also like to welcome the newest members of the Commission, 
Congressman Frank Wolf, Congressman Robert Pittenger, and Congressman 
Mark Meadows, and hope that the remaining appointments to the 
Commission will be made soon.
    In recent months, the world has once again been reminded just how 
closely our health and safety is tied to China.
    The current bird flu outbreak has claimed 36 lives and has spread 
to Taiwan.
    The discovery of 20,000 dead pigs floating in Shanghai and rat meat 
being passed off as lamb have renewed concerns about the safety of 
China's food exports.
    Pollution in Beijing and other cities has reached intolerable 
    And this spring marks the height of the SARS crisis ten years ago, 
which took 774 lives and touched nearly every corner of the globe.
    The risk to Americans has increased since we expanded trade 
relations with China without both providing for mechanisms to ensure 
safe imports, and without properly equipping our safety agencies with 
tools to ensure safe food.
    In 2001, when China entered the World Trade Organization, the total 
amount of Chinese goods exported to the United States was $102 billion. 
In 2012, that number had reached a staggering $426 billion.
    From 2001 to 2012, China's food exports to the United States 
reportedly tripled.
    Between 2003 and 2011 the volume of pet food exports from China to 
the United States grew 85-fold.
    Americans today might be surprised to learn just how much of their 
food and drugs are made in China. Some 80 percent of our tilapia, 50 
percent of our apple juice, and 30 percent of our garlic comes from 
    This increased reliance on China has had grave consequences. In 
2007, 149 Americans died after taking Heparin, a widely used blood 
thinner, linked to contaminants from Chinese workshops. Thousands of 
U.S. pets have died as a result of tainted treats from China.
    Part of the problem is that some of our companies are all too 
willing to take advantage of China's lax safety standards, creating an 
un-level playing field for our home-grown producers.
    But just as important has been China's failure to provide its 
citizens basic rights.
    Chinese citizens lack the political freedom to elect officials 
responsive to their concerns.
    There is no free press to help bring problems to public light
    There are no independent courts to ensure officials and companies 
follow the law.
    And there is no free civil society to sustain long-term advocacy.
    The costs of the current Chinese system are clear both to the 
Chinese people and to consumers everywhere.
    Without meaningful and effective pressure from their own citizens, 
Chinese officials still too often choose secrecy over openness and 
    Congress must also give close examination to our agencies 
responsible for safe drugs, food, and products and to the rules of 
international trade agreements, to ensure we do not lower standards.
    I look forward to the testimony of our witnesses, and turn to 
Congressman Smith for his statement.

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

                              may 22, 2013
    Welcome to our distinguished witness to this hearing on the 
important issues of food and drug safety, public health, and the 
environment in China. I also want to thank the staff of this commission 
for their work to raise awareness about these three issues, as well as 
other human rights, rule of law, and governance issues.
    Problems in the areas of food and drug safety, public health, and 
the environment deserve greater attention, research, and action; they 
affect countless people inside and outside of China. We hope to raise 
the visibility of these issues and that the Chinese government will 
respond in action, as well as words, to address the concerns of Chinese 
citizens and of all peoples who may be affected by imports of unsafe 
Chinese foods and drugs, by harmful pollution originating in China, or 
by public health crisis that take root in China.
    While China has had impressive economic growth for decades, it lags 
behind in ensuring the rights of its citizens, and in developing 
transparency, official accountability, the rule of law, things it 
sourly needs to tackle these three issues.
    Transparency is absolutely necessary for any government to protect 
the health of its citizens and to effectively manage problems related 
to food and drug safety, and public and environmental health. 
Therefore, it is unfortunate that it took about three weeks for Chinese 
health officials to make public information about the recent outbreak 
of bird flu.
    It is also unfortunate that authorities continue to deny citizens 
information on the levels of soil contamination across the country, 
despite media and citizen requests for that information. Soil 
contamination has led to high levels of cadmium in at least 44 percent 
of the rice in at least one southern province. Authorities revealed the 
names of 8 brands which had been affected only after widespread 
criticism in the media and online regarding officials' original 
statement that it was ``not convenient to reveal'' the names of the 
brands. It is unconscionable for authorities to put the health of 
Chinese citizens at risk by withholding this information to protect the 
images of the government and specific companies.
    In the past few months, over 20,000 pig carcasses have floated down 
rivers near Shanghai, but the Chinese government claims that there is 
no harm done to food or water quality. It is hard to get to the truth 
because central authorities are trying to control media coverage of 
these developments, telling journalists not to travel to locations to 
investigate. Keeping the media, citizens, and groups in the dark 
exacerbates food safety, health, and pollution problems.
    The list of food and drug safety problems in China is long and 
continues to grow. Some of the glaring problems over the last few years 
include toxic preserved fruit, baby formula and milk tainted with 
melamine, and produce contaminated by pesticides, just to name a few. 
94 million people in China become ill annually from food-borne 
diseases, and over 8,000 of these people die.
    These safety problems affect Americans. Between 2006 and 2010, U.S. 
officials prevented some 9,000 unsafe Chinese products from entering 
the United States. Chinese authorities' attempts to reign in the 
problems have not worked. Major corruption scandals in the food and 
drug agencies over the last few years indicate the top-down 
accountability systems are not working.
    The health of women due to the tragic forced abortions conducted 
under the coercive one-child policy which has been covered under 
previous hearings continues to cause tremendous pain and suffering both 
physical and emotional for millions.
    Chinese leaders continue to make commitments to improve food and 
drug safety at some future date, but when people are getting sick and 
dying, patience is no longer possible.
    Authorities in China need to be held accountable for implementing 
and enforcing laws the food and drug safety, public health, and 
environmental sectors. One of the ways to do that is to have authentic 
public oversight. Unfortunately, Chinese authorities continue to limit 
the growth of authentic civil society and citizen and group 
participation in policymaking and oversight processes is still very 

                       Submission for the Record


 Written Statement Submitted for the Record by Elizabeth Economy, C.V. 
 Starr Senior Fellow and Director for Asia Studies, Council on Foreign 

                              may 22, 2013

                China's Environmental Governance Crisis

    The Chinese government has traditionally placed limited value on 
transparency. Neither the political values of the Communist Party nor 
the institutional processes of the government inherently support 
sharing of information between the state and society or within the 
state itself. Recently, for example, the government announced that the 
results of a soil contamination survey indicated that 10 percent of all 
Chinese soil was contaminated with heavy metals and other pollutants. 
Yet it refused to release any further information on the grounds that 
the survey was a ``state secret.'' \1\ Transparency in China is 
unpredictable and episodic.
    \1\ Christina Larson, ``Soil Pollution Is a State Secret in 
China,'' Bloomberg BusinessWeek, February 25, 2013, 
    Nonetheless, within the past five years or so, the Chinese people 
have begun to demand greater transparency on issues that directly 
affect their well-being, such as the environment. Non-governmental 
organizations and the Internet increasingly bring the type of 
transparency that the people desire, sometimes working with, but more 
often working around, the country's formal political institutions.
                  to what extent is china forthcoming?
    The Chinese government does transmit some environmental 
information. The Ministry of Environmental Protection publishes an 
annual report with nationwide statistics on a range of issues, 
including water and air pollution, wastewater treatment, and land 
degradation. There is also a 2008 law designed to ensure that citizens 
have access to government information on environmental data. More 
recently, Beijing announced an initiative requiring that local 
governments above the county level inform the Ministry of Water 
Resources about construction projects in order to prevent salt water 
intrusion into strategic water reserves.\2\
    \2\ Elizabeth Economy, ``The environment,'' in Handbook of China's 
Governance and Domestic Politics, ed. Chris Ogden, (New York, NY: 
Routledge, 2012), 199-209.
    Yet passing laws and announcing initiatives on transparency are not 
the same as actually implementing them. In 2005, the predecessor to the 
Ministry of Environmental protection, the State Environmental 
Protection Agency (SEPA), launched the Green GDP campaign, a project 
designed to calculate the costs of environmental degradation and 
pollution to local economies and provide a basis for evaluating the 
performance of local officials. Several provincial leaders balked, 
however, worried that the numbers would reveal the extent of the damage 
suffered by the environment under their leadership. SEPA's partner in 
the campaign, the National Bureau of Statistics (NBS), also undermined 
the effort by announcing that it did not possess the tools to do Green 
GDP accounting accurately, and that in any case it did not believe 
officials should be evaluated on such a basis. After releasing a 
partial report in September 2006, the NBS refused to release its 
subsequent findings. While the initiative appeared to lay dormant for a 
number of years, in 2013, following an air pollution crisis in Beijing 
and other Chinese cities, the China Daily published a piece calling for 
a renewed effort toward adopting a Green GDP, asserting, ``It is 
generally believed that it is not technical limits but local 
governments that have prevented such data from being released. Such 
data releases might affect the promotion prospects of local officials. 
It is clear that if China wants to press on with the uphill task, it 
must first reshuffle its performance assessment methods for government 
officials.'' \3\ The message is unequivocal: until local cadres are 
held accountable for the environment by the central government, the 
green implementation gap will remain.
    \3\ China Daily, ``Green GDP needed,'' February 27, 2013, http://
    A similar problem with implementation plagues other government 
initiatives. The two most established formal mechanisms--public 
participation in the review of environmental impact assessments (EIAs) 
and the citizen complaint system--are only spottily implemented. With 
regard to public participation in EIAs, as Chinese scholars have noted, 
there are a number of limitations: only a small percentage of projects 
are subjected to compulsory public participation; the timing and 
duration of engaging the public is short; the method of selecting those 
who can participate is often biased; and the amount of information 
actually disclosed is often quite limited in an effort to prevent 
social unrest.\4\
    \4\ Yuhuan Zhang, Xiaowen Liu, Yunjun Yu, Guojian Bian, Yu Li, and 
Yingxian Long, ``Challenge of Public Participation in China's EIA 
Practice,'' (paper presented at the 32nd annual meeting of the 
International Association for Impact Assessment, Porto, Portugal, May 
27-June 1, 2012).
    Chinese citizens also have the right to engage the system through a 
formal complaint system: writing letters to local environmental 
protection bureaus complaining of air, water, and waste pollution. 
According to the 2010 Environmental Statistical Yearbook, in 2010, 
there were over 700,000 such complaints.\5\ During the 11th Five-Year 
Plan, the Ministry of Environmental Protection, itself, received 
300,000 petitions on environmental matters. But resolution of these 
issues remains difficult. All told, there were only 980 administrative 
court cases about environmental impact assessments and only thirty 
criminal cases from 2006 to 2010. It is estimated that not even 1 
percent of environmental disputes are resolved in court.\6\
    \5\ Ministry of Environmental Protection, ``2010 Environmental 
Statistical Yearbook [2010 Nian Huanjing Tongji Nianbao],'', http://
    \6\ Feng Jie and Wang Tao, ``Officials struggling to respond to 
China's year of environmental protests,'' China Dialogue, June 12, 
2012, http://www.chinadialogue.net/article/show/single/en/5438-
how much freedom do chinese people have to monitor and report on these 
                  issues and advocate for enforcement?
    If Beijing does not rigorously implement and enforce its 
environmental laws and regulations, Chinese non-governmental 
organizations (NGOs) and the Chinese people stand ready to intervene. 
Chinese environmental NGOs are at the forefront of pushing for greater 
transparency and disclosure. The Institute for Public Environment, 
headed by former journalist Ma Jun, for example, is renowned for its 
work in exposing multinationals whose supply chains often include 
small-scale factories that are violating environmental regulations. 
Once Ma uncovers a wrongdoing, he contacts the multinational and offers 
to work with it to get its environmental house in order. If the firm is 
unresponsive, he will use the Chinese media to shame the company into 
compliance. Greenpeace Beijing similarly applied the threat of media 
exposure to elicit change from large corporations, and successfully 
campaigned to persuade the supermarket group Metro to stop buying and 
selling Asia Pulp and Paper's rainforest-destroying paper products in 
    At the same time, some of the most challenging work in terms of 
bringing transparency to the environmental system is pursued on the 
legal front. Wang Canfa's Centre for Legal Assistance to Pollution 
Victims (CLAPV) is one of the very few resources for Chinese citizens 
who want to use a legal channel to pursue an environmental case. Over 
the past ten years, CLAPV has handled over 200 environmental lawsuits 
for pollution victims. In many instances, the media are an important 
ally in the NGO's fight for environmental protection, helping to shame 
polluters, uncover environmental abuse, and highlight environmental 
successes. Still, merely gaining access to the data to enable a case to 
be brought to trial remains a significant hurdle for many environmental 
    Beginning in 2009, Ma Jun also partnered with the U.S. NGO the 
Natural Resources Defense Council to launch an annual transparency 
index, which ``ranks the performance of 113 major Chinese cities in 
complying with environmental disclosure requirements.'' \7\ To 
accomplish this, they are using the 2008 law mandating transparency 
that Beijing, itself, could not effectively implement. While many 
cities still refuse to release the data--even though it is required by 
law--some Chinese officials have become fans of greater transparency as 
result of the NGO's work. One official from Hunan Province People's 
Congress uses his Weibo account to ``name and shame'' polluters, 
leading one named company to put in place new environmental clean-up 
    \7\ Barabara Finamore, Wang Yan, Wu Qi, and Christine Xu, ``A Step 
Forward for Environmental Transparency in China,'' National Resources 
Defense Council Staff Switchboard Blog, March 29, 2013, 
    \8\ Ibid.
    The advent of the Internet has further contributed to the ability 
of the Chinese people to apply bottom-up pressure for change, and has 
provided an unprecedented level of transparency in the environmental 
system, resulting in Internet petitions, water pollution maps 
demarcating polluting factories, and pictures of polluted sites or 
protesting Chinese. Urban residents also have become skilled at using 
the Internet and mobile phone text messaging to organize environmental 
    In one celebrated case, the Internet became a lightning rod for 
coalescing public opinion against local government regulations and 
resulted in a change in policy. On December 5-6, 2011, smog forced the 
cancellation of almost 700 flights at Beijing Capital Airport and 
ignited a media firestorm. The Beijing Municipal Bureau of 
Environmental Protection had reported the air pollution on December 5 
as ``light.'' \9\ However, the U.S. Embassy in Beijing, which had been 
Tweeting air quality numbers for several months, recorded the pollution 
level as `beyond index.' There were important differences in the 
pollutants on which Beijing reported (PM10) and those on 
which the U.S. Embassy reported (PM2.5 and ozone), and how 
each rated air quality, with the United States supporting tougher 
standards and metrics. Under pressure from China's online citizens, or 
netizens, the local Beijing environmental officials agreed to revamp 
their system by 2016 to report on additional pollutants. Yet that did 
not satisfy local residents. Real estate billionaire Pan Shiyi 
conducted an online poll and discovered that 91 percent of the more 
than 40,000 respondents believed that the government should immediately 
match the U.S. Embassy's reporting quality. One month later Beijing 
started to report on its air quality with the same statistical measures 
as the U.S. Embassy (albeit only from one site in the city). Moreover, 
on March 1, 2012, Beijing announced that it would extend its air 
pollution monitoring network to all major cities including Shanghai, 
Chongqing, and Tianjin in 2012, as well as incorporating 113 additional 
cities in 2013.\10\ By 2015, China plans to have all medium-to-large 
cities monitoring and reporting on their PM2.5 levels. Even 
China's official news agency, Xinhua, commented that social networking 
sites such as Weibo played an important role in spurring central 
leaders to take action on the issue.\11\
    \9\ Lousia Lim, ``Clean Air A `Luxury' In Beijing's Pollution 
Zone,'' NPR.org, December 7, 2011, http://www.npr.org/2011/12/07/
    \10\ Xinhua, ``PM2.5 in air quality standards, positive response to 
net campaign,'' March 1, 2013, http://news.xinhuanet.com/english/china/
    \11\ Elizabeth Economy, ``The environment,'' in Handbook of China's 
Governance and Domestic Politics, ed. Chris Ogden.
    Occasionally, even the government has begun to take advantage of 
the Internet to garner support for particular initiatives. For example, 
in the highly contentious South-North Water Transfer Project, netizens 
on the nationalistic and popular ``Strengthening the Nation'' online 
forum generally support the project, with some even arguing that 
cutting of the Yarlung Tsangpo river would not only help solve China's 
water shortage problems but also ``force India to compromise over 
disputed territory by controlling their water flow.'' \12\ At the same 
time, the Ministry of Water Resources, which does not support the third 
leg of the project, used the Internet to publish a series of articles 
less supportive of the project. Discussion on the project on their 
website was largely negative, with some referring to Western sources 
such as Jared Diamond and a movie about the National Parks Service to 
support their cause for why the project should not move forward.
    \12\ Strengthening the Nation Blog, ``Make the Brahmaputra River 
Flow into the Yangtze, the Distance Will Be the Smallest and the 
Benefits Will Be the Largest [Yin Yalucangbujiang Zhi Shuiru Changjiang 
Zhi Yuan, Juli Zuidian Xiaoyi Zuigao]'', February 8, 2009, http://
    The Internet also serves as an organizational tool for Chinese 
citizens to spread information regarding protests. The lack of an 
effective institutional mechanism for the Chinese people to participate 
in the environmental policy-making process or to get redress through 
the legal system has translated into a vibrant environmental protest 
movement in China. When citizens' concerns are not addressed 
satisfactorily, they turn to protest to make their voices heard, either 
via the Internet or on the street. The environment has now surpassed 
illegal land expropriation as the leading source of social unrest in 
the China.\13\
    \13\ Bloomberg News, ``Chinese Anger Over Pollution Becomes Main 
Cause of Social Unrest,'' March 6, 2013, http://www.bloomberg.com/news/
    In some cases, protests are virtual via the Internet. In late 2010, 
Chinese netizens broke the story of a significant environmental 
disaster in Jilin province, where thousands of barrels of pollutants 
had been dumped into a water source by a local chemical plant. In the 
ten days that it took Chinese officials to admit to the disaster, 
thousands of citizens were informed of the cover-up via the Internet. 
They responded by purchasing a massive amount of bottled water and 
angrily denouncing the government's inaction. It was only after the 
citizens refused to believe the official stories that the government 
finally acknowledged the disaster and handed out free bottles of water 
to those in the afflicted areas.\14\ Similarly, a year earlier in 
Guangzhou, online transparency caused a reversal in local government 
policy. Middle class-led protests over a planned incinerator were 
picked up by young online netizens, who then spread the news through 
social media websites. Even though the activists themselves were not 
affected by the plans, they wanted the word to get out. Once enough 
citizens became involved, the government agreed to halt the project 
until a full environmental assessment was completed.\15\
    \14\ Elizabeth Economy and Jared Mondschein, ``China: the New 
Virtual Political System,'' CFR.org (April 2011), http://www.cfr.org/
    \15\ Malcolm Moore, ``China's middle-class rise up in environmental 
protest,'' The Telegraph, November 23, 2009, http://
    Even more threatening to authorities is the potential for 
environmental protest to spread from one city to another. In July 2012, 
for example, protests broke out in the southwestern province of 
Sichuan, where citizens of the small city of Shifang were upset by a 
planned molybdenum copper plant. The facility would be a $1.64 billion 
project funded by the Sichuan Hongda Company,\16\ but residents of 
Shifang, led by students and joined by others from nearby towns and 
cities, feared that the plant would have a negative impact on the 
environment and their health.\17\ The state-supported Global Times 
estimated that several thousand protestors took part in the 
protests,\18\ which turned violent, forcing the police to use tear gas 
and stun grenades to disperse the crowds.\19\ Thirteen protestors were 
injured \20\ and another twenty-seven were detained during the 
protests, of which six were formally charged.\21\ On the third day of 
demonstrations, local officials announced that the project would be 
    \16\ Brian Spegele, ``Planned China Metals Plant Scrapped,'' Wall 
Street Journal, July 3, 2012, http://online.wsj.com/article/
    \17\ BBC, ``China factory construction halted amid violent 
protests,'' July 3, 2012, http://www.bbc.co.uk/news/world-asia-china-
    \18\ Ibid.
    \19\ Spegele, ``Planned China Metals Plant Scrapped.''
    \20\ BBC, ``China factory construction halted amid violent 
    \21\ Caixin Online, ``Timeline of Shifang Protests,'' July 5, 2012, 
    \22\ Ibid.
    Later that month, inspired by Internet reports of the Shifang 
protest, thousands of protesters took to the streets in Qidong, a 
coastal city in the province of Jiangsu, to challenge a pipeline that 
would discharge waste into the sea and potentially pollute a nearby 
fishery, as well as contaminate drinking water.\23\ Worried that 
wastewater originating from the Japan's Oji Paper Company in Nantong 
city would not be cleaned properly, a thousand or more protestors 
(Reuters reported there were about 1,000,\24\ while the Asahi Shimbum 
estimated 10,000 \25\) damaged government buildings, cars, and property 
on July 27.\26\ Some demonstrators clashed with police, and at least 
one police car was overturned; hundreds of police arrived later in the 
day to protect government offices.\27\ Fourteen people plead guilty to 
encouraging the riot in which dozens of police were injured; the local 
Communist party chief was stripped half-naked; and protestors caused 
more than $20,000 of damage.\28\
    \23\ Jane Perlez, ``Waste Project Is Abandoned Following Protests 
in China,'' The New York Times, July 28, 2012, http://www.nytimes.com/
    \24\ John Ruwitch, ``China cancels waste project after protests 
turn violent,'' Reuters, July 28, 2012, http://www.reuters.com/article/
    \25\ Bloomberg News, ``Chinese City Halts Waste Project After 
Thousands Protest,'' July 29, 2012, http://www.bloomberg.com/news/2012-
    \26\ Ibid.
    \27\ Ibid.
    \28\ Associated Press, ``Chinese protesters plead guilty after 
water pollution riot in Qidong,'' January 21, 2013, http://
    Public transparency may have reached a new high in May 2013, when 
Kuming, the capital city of the southwestern province of Yunnan, was 
rocked by protests over plans by China National Petroleum Corporation 
(CNPC) and the Yuntianhua Group to build a refinery in a nearby city of 
Anning. Kunming's mayor Li Wenrong took the unusual step of announcing 
that the government would cancel the project if ``most of our citizens 
say no to it.'' \29\ In essence, Li was inviting a public referendum on 
the project.
    \29\ Xinhua, ``Public opinion decisive in Kunming's controversial 
chemical project: mayor,'' May 10, 2013, www.globaltimes.cn/content/
    In virtually every instance of environmental protest in urban 
areas, local governments respond by acceding to the demands of the 
protestors. According to Ma Jun, director of the Institute of Public 
Environment in Beijing, ``The next leadership of China is going to face 
a challenge on these environmental issues, which the previous 
leadership had not seen so strongly for thirty years. For the first 
time, some local officials have begun to call us to learn more about 
how these situations are handled in other countries--they really worry 
about becoming the next protest targets.'' \30\
    \30\ Christina Larson, ``Protests in China Get a Boost From Social 
Media,'' Bloomberg BusinessWeek, October 29, 2012, http://
    The Chinese government appears at a loss as to how to manage the 
growing push from below for greater environmental transparency. 
Ignoring the people's demands comes with a high price: growing societal 
discontent and rising numbers of mass protests. Thus far, the 
leadership appears willing to pay the cost. However, the long-term 
effects--both on the environment and the leaders' own legitimacy--will 
only continue to grow.

    * The Council on Foreign Relations takes no institutional positions 
on policy issues and has no affiliation with the U.S. government. All 
statements of fact and expressions of opinion contained herein are the 
sole responsibility of the author.