[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]
JOINT HEARING ON IMPORT SAFETY
=======================================================================
HEARING
before the
SUBCOMMITTEE ON TRADE
of the
COMMITTEE ON WAYS AND MEANS
U.S. HOUSE OF REPRESENTATIVES
ONE HUNDRED TENTH CONGRESS
FIRST SESSION
__________
OCTOBER 4, 2007
__________
Serial No. 110-61
__________
Printed for the use of the Committee on Ways and Means
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49-993 WASHINGTON : 2009
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COMMITTEE ON WAYS AND MEANS
CHARLES B. RANGEL, New York, Chairman
FORTNEY PETE STARK, California JIM MCCRERY, Louisiana
SANDER M. LEVIN, Michigan WALLY HERGER, California
JIM MCDERMOTT, Washington DAVE CAMP, Michigan
JOHN LEWIS, Georgia JIM RAMSTAD, Minnesota
RICHARD E. NEAL, Massachusetts SAM JOHNSON, Texas
MICHAEL R. MCNULTY, New York PHIL ENGLISH, Pennsylvania
JOHN S. TANNER, Tennessee JERRY WELLER, Illinois
XAVIER BECERRA, California KENNY HULSHOF, Missouri
LLOYD DOGGETT, Texas RON LEWIS, Kentucky
EARL POMEROY, North Dakota KEVIN BRADY, Texas
STEPHANIE TUBBS JONES, Ohio THOMAS M. REYNOLDS, New York
MIKE THOMPSON, California PAUL RYAN, Wisconsin
JOHN B. LARSON, Connecticut ERIC CANTOR, Virginia
RAHM EMANUEL, Illinois JOHN LINDER, Georgia
EARL BLUMENAUER, Oregon DEVIN NUNES, California
RON KIND, Wisconsin PAT TIBERI, Ohio
BILL PASCRELL, JR., New Jersey JON PORTER, Nevada
SHELLEY BERKLEY, Nevada
JOSEPH CROWLEY, New York
CHRIS VAN HOLLEN, Maryland
KENDRICK MEEK, Florida
ALLYSON Y. SCHWARTZ, Pennsylvania
ARTUR DAVIS, Alabama
Janice Mays, Chief Counsel and Staff Director
Brett Loper, Minority Staff Director
______
SUBCOMMITTEE ON TRADE
SANDER M. LEVIN, Michigan, Chairman
JOHN S. TANNER, Tennessee WALLY HERGER, California
JOHN B. LARSON, Connecticut JERRY WELLER, Illinois
EARL BLUMENAUER, Oregon RON LEWIS, Kentucky
BILL PASCRELL, JR., New Jersey KEVIN BRADY, Texas
SHELLEY BERKLEY, Nevada THOMAS M. REYNOLDS, New York
JOSEPH CROWLEY, New York KENNY HULSHOF, Missouri
CHRIS VAN HOLLEN, Maryland
KENDRICK MEEK, Florida
______
SUBCOMMITTEE ON OVERSIGHT
JOHN LEWIS, Georgia, Chairman
JOHN S. TANNER, Tennessee JIM RAMSTAD, Minnesota
RICHARD E. NEAL, Massachusetts ERIC CANTOR, Virginia
XAVIER BECERRA, California JOHN LINDER, Georgia
RON KIND, Wisconsin DEVIN NUNES, California
BILL PASCRELL, JR., New Jersey PAT TIBERI, Ohio
JOSEPH CROWLEY, New York
Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public
hearing records of the Committee on Ways and Means are also published
in electronic form. The printed hearing record remains the official
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C O N T E N T S
__________
Page
Advisory of September 27, 2007 announcing the hearing............ 00
WITNESSES
Warren H. Maruyama, General Counsel, Office of the U.S. Trade
Representative................................................. 7
The Honorable Daniel Baldwin, Assistant Commissioner, Office of
International Trade, U.S. Customs and Border Protection,
Department of Homeland Security................................ 11
William James, DVM, MPH, Deputy Assistant Administrator for the
Office International Affairs, Food Safety and Inspection
Service, Department of Agriculture............................. 15
Steven M. Solomon, DVM, MPH, Deputy Director, Office of Regional
Operations, Office of Regulatory Affairs, Food and Drug
Administration, Department of Health and Human Services,
Rockville, Maryland............................................ 20
Marc J. Schoem, Director of Recalls and Compliance, U.S. Consumer
Product Safety Commission, Bethesda, Maryland.................. 37
______
Mark R. Berman, Chairman and Chief Executive Officer, Rockland
Industries, Inc., Baltimore, Maryland.......................... 52
Jean Halloran, Director of Food Policy Initiatives, Consumers
Union, Yonkers, New York....................................... 63
John Connelly, President, National Fisheries Institute, McLean,
Virginia....................................................... 68
John A. Williams, Executive Director, Southern Shrimp Alliance,
Tarpon Springs, Florida........................................ 73
Chris Knox, Vice President, Vest Inc., Los Angeles, California... 83
Craig Thorn, Partner, DTB Associates LLP......................... 90
The Honorable Cal Dooley, President and Chief Executive Officer,
Grocery Manufacturers Association and former Representative in
Congress from the State of California.......................... 98
SUBMISSIONS FOR THE RECORD
AdvaMed, statement............................................... 121
Airport Duty Free Stores, statement.............................. 123
American Academy of Pediatrics, statement........................ 124
AmeriSci Group, letter........................................... 129
Catfish Farmers of America, Indianola, MS, statement............. 132
Underwriters Laboratories, statement............................. 134
JOINT HEARING ON IMPORT SAFETY
----------
THURSDAY, OCTOBER 4, 2007
U.S. House of Representatives,
Committee on Ways and Means,
Subcommittee on Trade,
Washington, DC.
The Subcommittees met, pursuant to notice, at 10:05 a.m.,
in Room 2128, Rayburn House Office Building, Hon. John Lewis
[Chairman of the Subcommittee on Oversight] and Hon. Sander
Levin [Chairman of the Subcommittee on Trade] presiding.
[The advisory announcing the hearing follows:]
ADVISORY
FROM THE
COMMITTEE
ON WAYS
AND
MEANS
SUBCOMMITTEE ON OVERSIGHT
CONTACT: (202) 225-6649
FOR IMMEDIATE RELEASE
September 27, 2007
TR-6
Levin and Lewis Announce a Joint
Hearing on Import Safety
Ways and Means Trade Subcommittee Chairman Sander M. Levin (D-MI)
and Oversight Subcommittee Chairman John Lewis (D-GA) today announced
that the Subcommittees will hold a joint hearing on import safety. The
hearing will take place on Thursday, October 4, in the main Committee
hearing room, 1100 Longworth House Office Building, beginning at 10:00
a.m.
In view of the limited time available to hear witnesses, oral
testimony at this hearing will be heard from invited witnesses only.
However, any individual or organization not scheduled for an oral
appearance may submit a written statement for consideration by the
Subcommittees or for inclusion in the printed record of the hearing.
FOCUS OF THE HEARING:
This hearing will focus on the mechanisms and legal authorities
under current law for ensuring the safety of food and consumer products
imported into the United States. The hearing will examine how these
mechanisms and authorities are functioning, what problems may exist
with respect to each mechanism or authority, and what improvements are
needed. The hearing will look into the role of the U.S. Customs and
Border Protection (CBP) and CBP's coordination with the Food and Drug
Administration (FDA), the Food Safety Inspection Service (FSIS) and the
Consumer Product Safety Commission (CPSC) at the ports of entry. In
addition, the hearing will address the application of sanitary and
phytosanitary measures in the United States and overseas and the
consistency of those measures with the World Trade Organization (WTO)
rules.
BACKGROUND:
Recent incidents of contaminated food, unsafe toys, and other
products have led to an examination of the United States regulatory
framework for ensuring that imports meet U.S. public health, product
safety, and consumer protection standards. The ability of U.S.
Government regulators to identify and take action to prohibit the
importation of the unsafe imports is a critical part of the inquiry.
Last year, the United States imported 1.9 trillion of goods. A
growing portion of the American food supply is provided through
imports. For example, in 2005, more than 84 percent of all fish and
seafood was imported. Each day, 25,000 shipments of food are imported.
Similarly, Americans use and depend on imported products for
virtually every aspect of daily life, from toys to appliances. In 2006,
China was the largest supplier of imported toys, producing 86 percent
of toys played with by American children.
The United States has a complex structure at the ports of entry to
process imports and monitor compliance with American safety standards.
The composition of the President's Interagency Working Group on Import
Safety illustrates the multifaceted, multi-agency dimension of the
system. The Working Group is comprised of members from the following
departments, agencies, and Executive Office divisions: Health and Human
Services, State, Treasury, Justice, Agriculture, Commerce,
Transportation, Homeland Security, Management and Budget, United States
Trade Representative, Environmental Protection and the Consumer Product
Safety Commission.
The CBP, a component of the Department of Homeland Security, is the
primary border agency and the starting point for ensuring the safety of
all imports. In the area of food and product safety, CBP must
coordinate with a host of agencies, including the Department of Health
and Human Services and its Food and Drug Administration, the Department
of Agriculture's Food Safety and Inspection Service, and the Consumer
Product Safety Commission.
The Trade and Oversight Subcommittees are focused on providing CBP
with proper authority and appropriate enforcement tools for ensuring
import safety.
DETAILS FOR SUBMISSION OF WRITTEN COMMENTS:
Please Note: Any person(s) and/or organization(s) wishing to submit
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noted above.
Chairman LEWIS. Good morning.
The hearing is now called to order. Today the Subcommittee
on Oversight and Subcommittee on Trade review import safety.
This is the first hearing that I have had the pleasure of
cochairing with my good friend from Michigan that I've known
for many years, Chairman Levin.
It is unfortunate that the first opportunity that we have
had to work together is to discuss the really terrible,
terrible embarrassment to our country. It seems that
practically every week there's another product or food recall
announcement. Let me be clear, I believe that some of our
agencies have suffered by severe staff cuts and under-funding
in recent budget years. I continue to strongly support
increasing the funding for food and product safety standards
and enforcement.
Many of my colleagues co-signed a letter we sent to a
appropriator to increase funding for the Consumer Product
Safety Commission. You need to choose the resources, the staff,
and the authority to protect all American consumers.
I do not understand why it is so difficult to find a
single, clear source that agencies use to share recall
information with American consumers. Don't--sat that is, I've
sat with myself and I've tried to go through all of the website
and all of the links. It is a mess. It is very confusing. I do
not understand why a consumer cannot easily go to a single
source and learn exactly what toys are safe for their children,
what food is safe to eat, what beds are safe to sleep in, and
what medicines won't heal them.
Inspecting and stopping harmful products at the border is
common sense. It saves us from the headaches of tracking
defective products that are already in stores and homes; it is
a nightmare. We need to return to being proactive and not
reactive.
The creativity and ingenuity of the American people is what
made our country a great and powerful force. Our social and
economic movements have been a driving force in developing
labor, human rights, safety, and quality standards. We have
framed a debate, not just here at home, but all over the world.
It has not always been easy. It has not always been pretty, and
there is always much more to be done, but we have made progress
and there is still more progress to be made. America pushed the
envelope, pushed the debate, and opened doors.
In the 1970s safety was a priority of the Federal
Government. It was understood through the 1980s and much of the
1990s that the American consumer expected nothing less of being
the best. At some point, some place, we lost our way. The scrap
and test system has got to go. Flawed, defective products
should not continue to be a nightmare for American consumers.
In a global world we have the right to know who, what,
when, where, why, and how of all these items we use. Talking,
working together, and sharing information is not hard. We can
do better, and we must do better. I look forward to the
witnesses' testimony, thank each of you for being here this
morning.
Now it is my pleasure to recognize the distinguished
Chairman of the Subcommittee on Trade----
Chairman LEVIN. Let Ramstad go and then I'll go.
Chairman LEWIS. To recognize my Ranking Member, my good
friend Mr. Ramstad from the great state of Minnesota.
Mr. RAMSTAD. Well, I thank both chairmen for yielding time
and also for calling this hearing on the safety of our imports.
Also want to thank Chairman Levin, Ranking Member Herger, and
Chairman Lewis for their work on product safety. Obviously
very, very timely and important topic.
The United States consumes almost $2 trillion each year in
goods, and of course many sectors of our food market, like fish
and seafood, are overwhelmingly comprised of imports. Obviously
these imports raise our standards of living as they provide us
with fresh fruits and vegetables during the winter months, and
try growing fruits and vegetables in Minnesota during February.
So, we certainly are well aware of the importance of imports in
terms of food. Also, imports provide consumers access to
products that simply aren't grown or raised or made
domestically. So, imports, obviously, are an important part of
our--not only of our trade, but of our quality of life.
Having said that, however, American consumers obviously
need to know that the food and products they purchase are safe.
That should be axiomatic and certainly I don't think there's
any disagreement as to that caveat.
I look forward today, Mr. Chairman, to hearing how our
various Federal agencies are working to improve the inspection
and safety of our imports, and how private industry can partner
with these agencies to better improve these processes. After
all, it's the importers as well as the consumers who have the
most to lose if these safety issues aren't adequately
addressed.
With that, Mr. Chairman, I yield back the balance of my
time.
Chairman LEWIS. Thank you very much, Mr. Ramstad. Now I'm
pleased to recognize----
Chairman LEVIN. I'd just like to say that I'll speak and
then Herger--yeah, go ahead.
Chairman LEWIS. Now I'm pleased to recognize the
distinguished Chairman of the Subcommittee on Trade, a
gentleman I've known for many years, Mr. Levin from the state
of Michigan.
Chairman LEVIN. Well, thank you, thank you. You might say
many decades.
Chairman LEWIS. Many decades.
Chairman LEVIN. How pleased we are to be joining your
Subcommittee, Mr. Lewis and Mr. Ramstad. I think that the two
Subcommittees clearly have an important role to play here. I'll
be very brief, Mr. Chairman.
Expanded trade is here to stay. Globalization is here to
stay, but there's a critical issue and that is, how much we
need to shape the terms of expanded trade, how much we need to
act upon it or simply let it happen. Essentially I think what's
happened in recent months is an illustration of the need for us
to not only welcome expanded trade, but be vigilant about its
terms, its content, and its course, to have an active role in
shaping its course. There are some who essentially say, ``just
let it happen,'' but I think for the consumers of this
country--they're saying that we have to do better than that.
We welcome all of you who are here from various agencies. I
think everybody here realizes that you come here with some
constraints. You're part of an administration, in most cases,
but we do hope that you'll be as straightforward as you can be
because we need to know where the gaps are and how we fill
those gaps, because our constituents expect nothing less.
So, I yield back and the balance of my time, and I guess I
yield to Mr. Herger to take as much time as he would like.
Mr. HERGER. Thank you very much, Chairman Levin and
Chairman Lewis.
Americans have the right to know that all the products they
buy, whether imported toys or U.S.-grown spinach and beef, are
safe and healthy. We have seen several recent cases where the
products bought by American consumers were not safe. In most
cases, our system was able to catch these products before
significant harm was done. Unfortunately in some cases the
system was not. We need to carefully review the procedures we
have in place to ensure the safety and health of American
consumers.
I look forward to hearing from the Administration on the
steps it takes to ensure the safety of domestic and imported
products. I also would like to hear how the Administration is
seeking to enhance cooperation, excuse me--cooperation among
the many Federal agencies responsible for product safety,
especially the role of Customs and Border Protection officers
at our ports.
I also want to examine today all aspects of ensuring the
safety of the products Americans buy, whether foreign or
domestic. As the recent recalls of U.S. agriculture products
attest, and just this morning of white chocolate, this is not
just an import issue. The Administration is obviously taking
this issue seriously with the formation of the President's
Interagency Working Group on Import Safety. I'd like to hear
from the witnesses about the Working Group's initial report and
on what additional recommendations it will be making.
We must also realize that we cannot rely on border
inspections alone to ensure the safety of the products we
import. It is neither financially nor logistically feasible to
inspect every product imported into the country, nor would a
hundred percent inspection guarantee safety. Rather, we need to
work with producers throughout the supply chain, importers, and
foreign governments to ensure that all necessary steps are
taken to ensure the products they produce and ship are safe.
I believe we need a risk-based system that is flexible
enough to deal with the thousands of different types of
products purchased by Americans. The best system for ensuring
the safety of seafood is not necessarily the best system for
ensuring the safety of furniture. A one-size-fits-all approach
will not provide the most effective safety system for the
American consumer.
I also want to take this opportunity to point out that our
trade agreements do not force the United States to lower its
standards. In fact, our trade agreements allow us to raise the
safety standards of our trading partners because the burden is
on them to prove that the products exported to the United
States meet all safety requirements.
Several pieces of legislation would impose new user fees to
pay for increased inspections. Before we impose any new user
fees, I'd like to know whether such fees would actually improve
safety and whether they would unduly burden trade and increase
cost on consumers. Americans rely on imports. Whether it is
affordable toys, fresh fruit and vegetables in the winter, or
tropical products that do not grow in the United States, we
should resist the temptation to use unscientific restrictions
simply to limit imports in the name of health and safety.
Shutting off or severely limiting imports is not the
answer. We need a risk-based system that pushes out our borders
and ensures the safety of products through the entire supply
chain, from farm to factory to the final consumer.
I look forward to the testimony. Thank you, Mr. Chairman.
Chairman LEWIS. Thank you very much, Mr. Herger, for your
statement. Would any other Member like to make an opening
statement?
[No response.]
Now we will hear from our witnesses. I ask that each of you
limit your testimony to 5 minutes. Without objection your
entire statement will be included to the record. I will have
all of the witnesses give their statements, and then the
Members will ask questions of the entire panel.
It is now my pleasure and delight to introduce our first
witness, Mr. Warren Maruyama, the General Counsel of the Office
of the United States Trade Representative. Thank you, sir, for
being here.
STATEMENT OF WARREN H. MARUYAMA, GENERAL COUNSEL, OFFICE OF THE
U.S. TRADE REPRESENTATIVE
Mr. MARUYAMA. Chairman Lewis, Chairman Levin, and Members
of the Committee, it is a privilege to be here today to discuss
with you an issue of priority for every American household:
ensuring the safety of imported foods and consumer goods.
USTR does not have direct regulatory responsibility, but
the safety of the American consumer is paramount for us, just
like it is for every other U.S. government agency.
Under WTO rules and our Free Trade Agreements, the United
States has a right to determine the appropriate level of health
and safety protection for any product that is sold here. All of
our FTA's allow the United States, on the basis of a science-
based risk assessment, to apply appropriate measures to
safeguard life and health, as long as they do not arbitrarily
discriminate against imports. From the beginning, the GATT and
the WTO have recognized that nothing in trade agreements should
prevent parties from adopting legitimate measures to protect
human health, animal or plant life or health.
Accordingly, no foreign country can make us accept unsafe
products or force us to lower high U.S. safety standards. We
set our safety standards; not them. All imported food products,
including meat and poultry, seafood, dairy products, beverages,
and fruit and processed fruits and vegetables must meet the
same stringent food safety standards that apply to foods
produced in the United States.
Of course, we have a right to inspect imported foods at our
borders to determine if they are safe. U.S. inspectors review
import records, assisted by a computerized statistical sampling
system. Products are reviewed based on probable risk and given
special scrutiny based on heightened risk, For example, the
U.S. Food and Drug Administration recently inspected Chinese
seafood imports, determined that certain fish and shellfish
were being treated with unapproved antibiotics and food
additives, and immediately detained imports of these items into
this country until their safety could be assured.
At the same time, there are unprecedented challenges to
ensuring that America's food supply continues to be one of the
safest in the world and that American consumers continue to
have full confidence in the foods they eat, the medicines they
take, and the toys their children play with.
First, despite progress in food safety and important
advances in pathogen testing technology, recent outbreaks of
food-borne illness and the discovery of contaminated food and
feed products, involving both imported products from abroad and
products grown or manufactured in this country, underscore the
vital importance of continuing to improve and adapt our
systems, technologies, and strategies.
A second challenge is the unprecedented growth in trade
flows. Last year nearly $2 trillion of imported goods entered
the United States. Trade flows continue to grow, and many
experts believe that trade volumes could triple by 2015. The
expansion of trade has brought our consumers the benefits of
winter vegetables from Latin America; innovative, life-saving
medical discoveries from Europe and Japan; and low-cost shoes,
toys, and apparel from Asia, but the increase also means that
there are more imported goods crossing our borders. While 20
years ago most food and beverage products were imported from
Canada or Western Europe, today we import food products from
just about every corner of the world. This means that American
consumers have access to an unprecedented array of dietary
choices, but with this choice has come new challenges to
ensuring appropriate adherence to U.S. safety standards in
products shipped from 150-plus countries.
Finally, America is a major exporter of beef, pork and
poultry, grains and oilseeds, processed foods, medical devices,
cars, and a host of other products that are subject to foreign
safety requirements. So, if we were to deviate from science-
and risk-based regulation and erect protectionist barriers to
trade in the guise of consumer safety, U.S. exports would be
vulnerable to mirror restrictions, and some of our trading
partners would be only too happy to oblige.
This is a critically important issue for American
agriculture. Overall U.S. agricultural exports are up from 50.7
billion in Fiscal Year 2000 to a projected 79 billion in Fiscal
Year 2007. The growth in United States agriculture has occurred
as a result of both the multilateral 1994 Uruguay round
Agreement on Agriculture and our FTA's. Because of NAFTA,
Canada and Mexico have emerged as the top two export markets
for American agriculture.
Moreover, much of the recent growth in U.S. farm exports is
coming from emerging markets, while exports to traditional
high-income markets, like the European Union and Japan, have
stagnated. As a result, the share of U.S. farm and food exports
destined from emerging markets has climbed from 30 percent
during the early nineties to 43 percent in 2006. China and
Mexico now account for a quarter of U.S. farm imports, nearly
triple their share in 1990. Exports to China alone are now
nearly equal to exports to Europe. I don't need to explain to
the Subcommittee how easy it is for foreign countries to lock
out American farm imports through spurious sanitary and
phytosanitary measures, just as they have been known to
restrict, for example, U.S. manufactured goods through
protectionist barriers that are dressed up as legitimate
passenger safety or regulatory standards.
At the direction of the President, Health and Human
Services Secretary Leavitt is chairing an Interagency Import
Safety Working Group that is engaged in a top-to-bottom review
of the U.S. import safety system. Secretary Leavitt has made
clear that he's prepared to take a fresh look at each and every
aspect of our system and that nothing is sacred.
Mr. Chairman, the benefits of international trade are wide-
ranging, yet these benefits bring with them new and complex
responsibilities for government and the private sector, for
U.S. and foreign producers, American growers--okay.
Mr. Chairman, the U.S. food safety system is the import--is
one of the safest in the world. We at USTR look forward to
working with you to keep it that way. Thank you for inviting me
to testify today on these critical issues.
[The prepared statement of Mr. Maruyama follows:]
Prepared Statement of Warren H. Maruyama, General Counsel,
Office of the U.S. Trade Representative
Chairman Levin, Chairman Lewis, and Members of the Committee, it is
a privilege to be here to today to discuss an issue of priority for
every American--ensuring the safety of imported foods and consumer
goods.
USTR does not have direct regulatory responsibility, but the safety
of the American consumer is paramount for us, just like it is for every
other U.S. government agency.
Under the World Trade Organization (WTO) rules and our Free Trade
Agreements (FTAs), the United States has a right to determine the
appropriate level of health and safety protection for any product that
is sold in the United States. All of our FTAs allow the United States,
on the basis of a science-based assessment of specific risk, to apply
appropriate measures to safeguard life and health, so long as our
requirements do not arbitrarily discriminate against imports. From the
beginning, the General Agreement on Tariffs and Trade (GATT) and WTO
have recognized that nothing in trade agreements should prevent parties
from adopting legitimate measures to protect human, animal, or plant
life or health.
Accordingly, no foreign country can make us accept unsafe products,
or force us to lower high U.S. safety standards. We set our safety
standards. All imported food products, including meat and poultry,
seafood, dairy products, beverages, and fresh and processed fruits and
vegetables must meet the same stringent food safety standards that
apply to foods produced in the United States.
And, of course, we have a unilateral right to inspect imported
foods at our borders to determine if they are safe. U.S. inspectors
review import records, assisted by a computerized statistical sampling
system. Products are reviewed based on their probable risk and given
special scrutiny based on heightened risk. For example, under the U.S.
Food and Drug Administration's (FDA's) recent seafood safety measures,
FDA inspected Chinese seafood imports, determined that certain fish and
shellfish were being treated with unapproved antibiotics and food
additives, and immediately detained imports of these items into the
United States until the safety of those products could be assured.
At the same time, there are unprecedented new challenges to
ensuring that America's food supply continues to be one of the safest
in the world, so that American consumers continue to have full
confidence in the foods they eat, the medicines they take, and the toys
their children play with.
First, despite progress in the areas of food safety and important
advances in pathogen testing technology, recent outbreaks of food-borne
illness and the discovery of contaminated food and feed products--
involving both imported products from abroad and products grown or
manufactured in this country--underscore the vital importance of
continuing to improve and adapt our systems, technologies, and
strategies to a rapidly changing and growing global economy.
A second challenge is the unprecedented growth in trade flows. Last
year, nearly $2 trillion of imported goods entered the United States.
Trade flows continue to grow, and many experts believe that volumes
could triple by 2015. The expansion of trade has brought our consumers
the benefits of fresh winter vegetables from Latin America, innovative
life-saving medical discoveries from Europe and Japan, and low-cost
shoes, toys, and apparel from Asia, but the increase also means that
there are more imported goods entering our borders. And while 20 years
ago, most food and beverage products were imported from Canada or
Western Europe, today we import food products from just about every
corner of the world. This means that American consumers have access to
an unprecedented array of dietary choices, but with this choice has
come new challenge to ensuring appropriate adherence to U.S. safety
standards in products shipped from 150-plus countries from around the
globe.
Finally, America is a major exporter--of beef, pork and poultry,
grains and oilseeds, processed foods, medical devices, cars, and a host
of other products that are subject to foreign safety requirements. So
if we were to move away from science and risk-based regulation, and
erect protectionist barriers to trade unchecked by WTO and FTA rules in
the guise of consumer safety, U.S. exports would be highly vulnerable
to mirror restrictions, and some of our trading partners would be only
too happy to oblige.
This is a critically important issue for American agriculture.
Overall, U.S. agricultural exports are up from $50.7 billion in FY 2000
to a projected $79 billion in FY 2007. The growth in United States
agriculture has occurred as a result of both the multilateral 1994
Uruguay Round Agreement on Agriculture, which created new market access
opportunities for American farmers and ranchers and our FTAs. In 2006,
U.S. agricultural exports to markets covered by FTAs reached $26
billion, about 38 percent of total U.S. agricultural exports, compared
to just $255 million, or about one-half of one percent of total U.S.
agricultural exports in 1986. Because of NAFTA, Canada and Mexico have
emerged as the top two export markets for American agriculture.
Moreover, much of the recent growth in U.S. farm exports is coming from
emerging markets, while exports to our traditional high-income markets
like the European Union and Japan have stagnated. As a result, the
share of U.S. farm and food exports destined for emerging markets
climbed from 30 percent during the early 1990s to 43 percent in 2006.
China and Mexico now account for a quarter of U.S. farm exports, nearly
triple their share in 1990. Exports to China alone are now nearly equal
to exports to Europe. I don't need to explain to this Subcommittee how
easy it is for foreign countries to lock out American farm exports
through spurious sanitary and phytosanitary measures, just as they have
been known to cynically restrict, for example, U.S. manufactured goods
through protectionist barriers that are dressed up as legitimate
passenger safety or regulatory standards.
At the direction of the President, Health and Human Services
Secretary Leavitt is chairing an inter-agency Import Safety Working
Group that is engaged in a top-to-bottom review of the U.S. import
safety system for food, drugs, devices, and other consumer products. On
September 10, 2007, Secretary Leavitt submitted an interim report to
the President. The report urges a fundamental shift in strategic
emphasis from traditional border-based inspections and interventions to
a comprehensive ``life cycle'' strategy that focuses on identifying and
managing risks through every step of the product life cycle--building
safety into products from the very beginning of the supply chain. Such
a strategy will require working with foreign producers, U.S. importers,
and U.S. retailers to build safety into design, manufacturing, and
distribution processes, backed up by government and private sector
verifications, certifications, and border inspections. The focus should
be on managing risk, using the best of science and technology, and best
practices from the private sector, and governments around the world.
The Working Group is currently working on a follow-up report that will
contain specific recommendations for implementing such an approach and
ensuring that the American public continues to have full confidence
that our system is one of the safest in the world.
Conclusion
The benefits of international trade are wide-ranging, yet these
benefits bring with them new and complex challenges--for government and
the private sector; for U.S. and foreign producers, growers, retailers,
importers, and consumers; and ultimately for Congress and the Executive
Branch. The American public properly has high expectations for the
safety of the food they eat and the products they and their children
use. The U.S. food supply is one of the safest in the world due to the
cooperation and active participation of all stakeholders--farmers,
industry, exporters, importers, and consumers--in protecting the entire
U.S. food chain. We at USTR look forward to working with you to keep it
that way. Thank you for inviting me to testify today on these critical
issues.
Chairman LEWIS. That each member of the panel to try to
limit your statement to 5 minutes. Your entire statement will
be added to the record. This is a very important issue; we want
to get your full statement in if at all possible.
Our next witness is from the United States Customs and
Border Protection. I am pleased to welcome the Honorable Daniel
Baldwin, the Assistant Commissioner of the Office of
International Trade. Welcome.
STATEMENT OF THE HONORABLE DANIEL BALDWIN, ASSISTANT
COMMISSIONER, OFFICE OF INTERNATIONAL TRADE, U.S. CUSTOMS AND
BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY
Mr. BALDWIN. Thank you, Chairman Lewis, Chairman Levin, and
Members of the Subcommittee.
I'm pleased to appear before you today to discuss the
actions we are taking at Customs and Border Protection to
ensure the safety of imported products. My name is Daniel
Baldwin. I am the Assistant Commissioner of the Office of
International Trade at CBP. My office holds the responsibility
of formulating CBP's trade policy, developing programs, and
enforcing U.S. import laws.
The recent increase and discoveries of tainted consumer
products is an issue that falls within the purview of my
office. In response to recent dangers found in some imported
apparel, pet food ingredients, toys, seafood, and other
products, the President issued an executive order establishing
an Interagency Working Group on Import Safety. That working
group, chaired by Health and Human Services Secretary Leavitt,
is comprised of senior officials from 12 Federal departments
and agencies, each with a unique and critical import safety
responsibility.
CBP is actively participating in the Working Group and has
assigned a senior manager to work full time with the group. She
and other CBP staff assisted with the development of the
Strategic Framework for Continual Improvement in Import Safety
released on September 10th. That strategic framework developed
by the working group consists of three organizing principles:
prevention, intervention, and response. Within these three
principles, the Working Group has targeted six building blocks
for further action.
In recent years CBP has worked extensively to coordinate
activities and enforcement actions with other government
agencies, such as USDA and HHS. As the guardian of our Nation's
borders, CBP has broad authority to interdict imports at the
ports of entry. We identify, target, and interdict high-risk
shipments using our data along with information from other
agencies. It is important to note that long before the recent
headlines CBP had been working with agencies such as the
Consumer Product Safety Commission on identifying and
interdicting products such as flammable children's sleepwear
and other products that present a danger to our citizens.
CBP has several tools to interdict potentially unsafe
imports. In my testimony today, I'd like to highlight two of
these tools that CBP can utilize to interdict unsafe imports:
first, CBP qualified personnel, and second, CBP targeting
methodology.
As I noted, CBP often coordinates with other agencies to
interdict and seize unsafe imports. Action under CBP purview
takes place at the frontline. Our diverse workforce on the
frontline enables CBP to mount rapid and effective responses by
utilizing the specialized expertise of CBP officers,
agriculture specialists, import specialists, international
trade specialists, and laboratory technicians. Each of these
CBP functions can work together to gather intelligence,
establish targeting criteria, gather and test samples, and
report on results.
The second tool, our targeting efforts. We're able to use
various targeting mechanisms to ensure the compliance of
products imported into the United States. These mechanisms are
specifically designed to incorporate the safety concerns of
other agencies in identifying high-risk imports. CBP currently
uses the Automated Targeting System, Automated Manifest System,
and the Automated Commercial System. CBP uses these three
systems to target high-risk cargo, screen inbound merchandise,
and process import entries.
There are a couple of key tenets of the Import Safety
Working Group that CBP fully supports. First, the Working Group
has noted a major challenge related to the need for inter-
operability. The International Trade Data System, or ITDS, is a
key component to improve safety and to improve systems inter-
operability. The recently enacted Security and Accountability
For Every, or SAFE, Port Act of 2006 established a requirement
of electronic interface for all Federal agencies that monitor
or control the movement of imported products in domestic
commerce.
The Working Group has taken a strong step toward
establishing inter-operable computer systems. On September
10th, the OMB circulated a directive to heads of departments
and agencies participating in the Working Group, requiring that
each designate a representative to coordinate their agency's
involvement in ITDS. We at CBP believe that this will maximize
the functionality of ITDS and will re-energize the effort to
build inter-operable systems. Requiring additional government
agencies to participate in ITDS marks a strong first step in
improving safety.
The Working Group has established a sound framework for
further exploration of ways to improve safety of our American
imports. The Working Group has highlighted the need to shift
from reliance on a ``snapshot'', where unsafe products are
simply interdicted at the border, to a cost-effective,
prevention-focused ``video'' model that identifies targets, and
those critical points in the import life cycle where the risk
of unsafe products is greatest and verifies the safety of
products at those most important phases.
CBP remains committed to partnering with our Federal
agencies in order to refine our targeting skills and increase
our coordination and collaboration of government personnel, and
to ensure the prevention of contaminated and dangerous products
from entering the United States.
I thank you for the opportunity to testify, and I'm happy
to field any questions.
[The prepared statement of Mr. Baldwin follows:]
Prepared Statement of The Honorable Daniel Baldwin,
Assistant Commissioner, Office of International Trade,
U.S. Customs and Border Protection,
Department of Homeland Security
INTRODUCTION
Mr. Chairman and Members of the Subcommittee, I am pleased to
appear before you today to discuss the actions we are taking at Customs
and Border Protection (CBP) within the Department of Homeland Security,
to ensure the safety of imported products. My name is Dan Baldwin and I
am the Assistant Commissioner in the Office of International Trade at
U.S. Customs and Border Protection. My office holds the responsibility
of formulating CBP's trade policy, developing programs, and enforcing
U.S. import laws.
NATIONAL TRADE STRATEGY
As a general rule CBP has not targeted imports based on import
safety criteria alone. Pursuant to our twin goals of fostering
legitimate trade and travel while securing America's borders, CBP has
developed a National Trade Strategy to help our agency successfully
fulfill our trade facilitation and trade enforcement mandate. CBP trade
enforcement focuses on the collection of import duties and the
enforcement of trade laws. Our National Trade Strategy is based upon
six Priority Trade Initiatives (PTI). These PTI's are: Antidumping and
Countervailing Duty, Intellectual Property Rights, Textiles and Wearing
Apparel, Revenue, Agriculture, and Penalties. Under the terms of our
trade prioritization strategy we focus CBP resources in our efforts to
address areas of key trade importance.
In recent years, CBP has worked extensively to coordinate
activities and enforcement actions with USDA and HHS, and in particular
the FDA. As the guardian of our Nation's borders, CBP has broad
authority to interdict imports at the Port of Entry. We identify,
target, and interdict high-risk shipments using our data along with
information from other agencies. For instance, we frequently interact
with USDA and FDA on questions regarding food enforcement action, as
those departments house the subject matter expertise on food and
agriculture admissibility standards. CBP enforces safety regulations by
relying on the statutory authority of other Federal agencies with the
specific mandate of safety issues. It is important to note, also, that
long before the recent headlines CBP had been working with agencies
such as the Consumer Product Safety Commission (CPSC) on identifying
and interdicting products such as flammable children's sleepwear and
other products that present a danger to our citizens.
As the value and volume of our imports continue to grow, CBP
recognizes the challenges we face in maintaining safe and secure
imports. To meet these challenges, President Bush issued Executive
Order 13439 on July 18, 2007, establishing an Interagency Working Group
on Import Safety (Working Group). The Working Group, chaired by Health
and Human Services Secretary Michael O. Leavitt, is comprised of senior
officials from 12 Federal departments and agencies, each with unique
and critical import safety responsibilities. The review was ordered by
the President to ensure that our work with the private sector and
foreign counterparts would be comprehensive and effective in promoting
the safety of imported products.
CBP is actively participating in the Working Group and has assigned
a senior manager to work full time with the group. She and other CBP
staff assisted with the development of the ``Strategic Framework for
Continual Improvement in Import Safety'' released by Secretary Leavitt
on September 10, 2007.
The Strategic Framework developed by the Working Group is a risk-
based approach and consists of three Organizing Principles: 1)
Prevention, 2) Intervention, and 3) Response Within these three
principles the Working Group has targeted six Building Blocks for
further Administration action. Some of these Building Blocks
specifically focus on enhancing current CBP capabilities and programs.
CBP CAPABILITIES
CBP has several tools to interdict potentially unsafe imports. In
my testimony today, I would like to highlight two of these tools that
CBP can utilize in order to interdict unsafe imports: CBP Personnel and
CBP Targeting.
PERSONNEL
CBP maintains a diverse workforce that works to assist, detect and
interdict imports that may be harmful to the health of the American
public. For instance, CBP Officers and CBP Agriculture Specialists
receive specific training on ag/bio-terror incidents. We currently have
the ability to deploy more than 18,000 CBP Officers, 2,000 Agricultural
Specialists, and 1,000 Import Specialists in response to emerging
threats to American consumers. Furthermore, CBP's Laboratory and
Scientific Services (LSS) maintains seven separate laboratories around
the country, with a 24/7 technical reach back center and employs
approximately 220 chemists, biologists, engineers, and forensic
scientists.
Our workforce enables CBP to mount rapid and effective responses by
utilizing the specialized expertise of CBP Officers, Agriculture
Specialists, Import Specialists, International Trade Specialists, and
Laboratory Technicians. Within existing authorities, each of these CBP
occupations can work together to gather intelligence, establish target
criteria, gather and test samples, and analyze and report results.
TARGETING
In addition to our skilled workforce, CBP uses various targeting
mechanisms to ensure the compliance of products imported into the U.S.
These mechanisms are specifically designed to incorporate the safety
concerns of other agencies in identifying high-risk imports.
One of the systems used is CBP's Automated Targeting System (ATS).
ATS, which is based on algorithms and rules, is a flexible, constantly
evolving system that integrates enforcement and commercial databases.
ATS is the system through which we process advance manifest information
to detect anomalies and ``red flags,'' and determine which cargo is
``high risk'' and should be scrutinized at the port of arrival. ATS is
essential to CBP's ability to target high-risk cargo entering the
United States.
Another system CBP uses is the Automated Manifest System, which
provides us with advance cargo information to be used for targeting and
screening of all imported merchandise. This advance information allows
CBP to identify shipments of interest in advance of arrival. By
identifying shipments early, CBP is better able to focus resources on
those shipments that may be of concern, prevent their introduction into
the commerce and ensure appropriate coordination with other regulatory
agencies.
The Automated Commercial System (ACS), CBP's automated system of
record for entry processing and cargo clearance, allows us to screen
for additional food and agricultural risks. The majority of the
targeting criteria present in this system are used to prevent the
introduction of contamination, pests, or diseases.
In addition to these CBP automated systems, CBP maintains the
National Targeting Center (NTC). The NTC is the facility at which
personnel from a number of government agencies are co-located to review
advance cargo information on all inbound shipments. At the NTC, CBP
personnel are able to quickly coordinate with personnel from other
Federal agencies such as the FDA, Food Safety and Inspection Service
(FSIS), and Animal Plant Health Inspection Service (APHIS) to target
high-risk food shipments.
Furthermore, the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (know as the Bioterrorism Act, or
BTA) authorized FDA to receive prior information to target shipments of
food for humans or animals prior to arrival. The Bioterrorism Act gave
CBP the opportunity to assist FDA with the prior notice requirements.
CBP worked in concert with FDA to augment an existing automated
interface to institute a prior-notice reporting requirement with
minimal disruption to the trade. In addition, under the Bioterrorism
Act, we worked with FDA to commission over 8,000 CBP officers to take
action on behalf of the FDA. This commissioning allows FDA to assert a
24/7 presence to enforce the Act at all ports.
A major challenge we face in our operations is the need for
interoperability. Interoperability is the ability of one system to
communicate with another. Too often, we build sophisticated data
systems without ensuring the systems' ability to interface with one
another. We need to finalize implementation of interoperable data
systems, already under development, that facilitate the exchange of
relevant product information among parties within the global supply
chain to ensure import safety.
Government agencies should share the information they collect about
activities occurring along the global supply chain to prevent,
identify, mitigate, and respond to product safety hazards.
Manufacturers test products to ensure that they comply with relevant
performance and safety standards; government agencies inspect and test
products to ensure that they meet regulatory requirements associated
with public health, environmental safety, and consumer protection.
Marketplace recalls are conducted to remove faulty or unsafe products
from commerce. Information about these activities is often collected
and recorded, and should be shared among individual actors in the
import life cycle or aggregated and analyzed as a whole.
Information technology has improved the availability and exchange
of information on imported products. The import entry process is one
area where information technology is being used to improve the exchange
of import supply chain information. Throughout most of U.S. history, a
revenue-centric import system focused largely on the collection of
customs duties on imported goods. In the post-9/11 environment,
however, government and industry have recognized the need to expand the
focus of the import system to encompass security and safety.
The International Trade Data System (ITDS) is a key component to
improve systems interoperability. The recently enacted Security and
Accountability for Every (SAFE) Port Act of 2006 established a
requirement for an electronic interface among all Federal agencies that
monitor or control the movement of imported products in domestic
commerce. The ITDS will create a single-window environment in which
importers, transportation carriers, and government agencies can
exchange information on imported products. When fully implemented, ITDS
will facilitate the processing of legitimate import transactions,
improve how imported products are identified and classified, strengthen
entry screening capabilities, and help to target inspection resources
to areas of greatest risk.
CONCLUSION
The Working Group has set out a sound framework for developing
specific ways to improve the safety of American imports, and we are
assisting the Working Group in developing a follow-on Action Plan. The
Working Group has highlighted the need to shift from reliance on
``snapshots'' wherein unsafe products are simply interdicted at the
border, to a cost-effective, prevention-focused ``video'' model that
identifies and targets those critical points in the import life cycle
where the risk of unsafe products is greatest and verifies the safety
of products at those important phases.
CBP remains committed to partnering with other Federal agencies in
order to refine our targeting skills and increase coordination of
government personnel and to ensure the prevention of contaminated and
dangerous products from entering the U.S.
Chairman LEWIS. Thank you very much.
Our third witness, I'm pleased to welcome William James
from the Department of Agriculture, Food Safety and Inspection
Service. He is a deputy assistant administrator for the Office
of International Affairs.
Welcome, Mr. James.
STATEMENT OF WILLIAM JAMES, D.V.M., M.P.H., DEPUTY ASSISTANT
ADMINISTRATOR FOR THE OFFICE OF INTERNATIONAL AFFAIRS, FOOD
SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE
Mr. JAMES. Chairman Lewis and Chairman Levin, Members of
the Subcommittee, thank you for the opportunity to provide
testimony to you on behalf of USDA's Food Safety and Inspection
Service.
FSIS is the USDA public health regulatory agency
responsible for ensuring that the Nation's commercial supply of
meat, poultry, and egg products is safe, wholesome, and
properly labeled. I am here today to discuss FSIS procedures
for ensuring the safety of the imported food for which we have
responsibility. In fiscal year 2006, the imported food FSIS
oversees accounted for nearly 4 billion pounds of meat and
poultry from 29 of the 33 eligible countries, and about 6
million pounds of egg products from Canada presented for import
re-inspection at U.S. ports and borders.
FSIS employs a comprehensive three-part system for imports.
This system consists of establishing the initial equivalence of
the meat inspection system of a country wishing to export to
the U.S., verifying continuing equivalence of foreign systems
through audits, and providing 100 percent re-inspection, with a
few exceptions, when products enter the country.
Equivalence is the foundation for our system of imports. It
recognizes that an exporting country can provide an appropriate
level of sanitary protection, even though the measures employed
to achieve this protection may be different from those at home.
FSIS begins the process of determining equivalence by
analyzing the country's meat or poultry regulatory system with
a document analysis to assess whether the country has laws,
regulations, and the infrastructure to support an equivalent
system. The document review focuses on a country's practices in
five risk areas: sanitation, animal disease, slaughter and
processing, residues, and enforcement. If the document review
is satisfactory, we then move to on-site review, in which an
FSIS audit team evaluates all aspects of a country's inspection
program including individual establishments and laboratories.
The second part of our system is verifying continuing
equivalence through audits. Once a country is determined to
have a system equivalent to the U.S., that country is
responsible for ensuring that all facilities exporting to the
United States employ standards equivalent to those of the U.S.
To verify that this is happening, FSIS conducts annual audits
of foreign food safety systems through on-site visits by FSIS
personnel. Again, these include certified establishments,
laboratories, and a review of government controls.
Finally, the last major part of our system is verifying
continuing equivalence of foreign systems through re-inspection
at the border. Every shipment of meat, poultry, or egg products
entering the United States must be presented to an FSIS
inspector at a FSIS import establishment. Initial checks
include documentation, transportation damage, and proper
labeling.
FSIS also performs intensive, random re-inspection on
approximately 10 percent of shipments of meat, poultry, and egg
products. These re-inspection tests include product
examinations, microbiological analysis for pathogens, and/or
tests for chemical residues. Acceptable products are marked as
``Inspected and Passed'' and released into commerce. Non-
compliant products are rejected, marked as ``Refused Entry,''
and either destroyed or returned to the originating country.
More intensive re-inspection is automatically applied to future
shipments of products from the foreign establishment when
product fails re-inspection.
In addition to import re-inspection personnel, FSIS
currently employs 23 Import Surveillance Liaison Officers who
are charged with identifying, tracking, and detaining
ineligible, illegal, or smuggled product. These ISLO's work
closely with other governmental agencies, including Customs and
Border Protection. Access to Customs and Border Protection's
Automated Commercial Environment Database has provided FSIS a
more targeted approach to identifying and controlling
ineligible entries of amenable product closer to the entry
point, rather than after its release into commerce. The Agency
and other Federal partners are working to become fully
integrated with that system, an effort that will eventually
lead to a linkage of all inspection border control data systems
among all Federal agencies involved in imports.
Now, in addition to our three-part approach, the Agency is
also focused on protecting against accidental or intentional
food contamination. Through vulnerability assessments we have
been able to seek out ways to strengthen our system, and
through comprehensive training, which is shared with our food
defense partners, we are better able to prevent and respond to
any potential threats to the food supply.
Finally, USDA is working closely with the Interagency
Working Group on Import Safety chaired by Health and Human
Services Secretary Mike Leavitt. The framework offered by the
Working Group in September outlines an approach to food safety
and imports based upon the principles of prevention,
intervention, and response, supporting USDA's longstanding
approach to the issue.
In conclusion, at FSIS we believe that our approach to
ensuring the safety of imported meat, poultry, and egg products
is the best system in the world. This is due to our three-part,
rigorous approach to determining equivalence, the continuous
evaluation of that equivalence to ensure that it is maintained,
and our vigilant surveillance of food products entering the
country.
Mr. Chairman and all Members of the Subcommittee, I would
like to thank you for this opportunity to explain the important
process that FSIS employs in protecting consumers by assuring
the safety of imported food products.
[The prepared statement of Mr. James follows:]
Prepared Statement of William James, DVM, MPH,
Deputy Assistant Administrator for the Office International Affairs,
Food Safety and Inspection Service, Department of Agriculture
Mr. Chairman and Members of the Subcommittee, I am Dr. William
James of the Office of International Affairs at the United States
Department of Agriculture's Food Safety and Inspection Service.
The Food and Safety and Inspection Service is the USDA public
health regulatory agency responsible for the administration of laws and
regulations that are designed to ensure that the Nation's commercial
supply of meat, poultry, and egg products is safe, wholesome, and
properly labeled. I am here today to discuss FSIS' procedures for
ensuring the safety of the imported food for which we have
responsibility. In FY 2006, the imported food FSIS oversees accounts
for nearly four billion pounds of meat and poultry from 29 of the 33
eligible countries; and about six million pounds of egg products from
Canada presented for import re-inspection at U.S. ports and borders.
FSIS employs a comprehensive three part system for imports. This
system consists of:
Establishing the initial equivalence of the meat
inspection system of a country wishing to export to the United States;
Verifying continuing equivalence of foreign systems
through audits; and
Providing 100 percent re-inspection, with a few
exceptions, when products enter the country.
Establishing Equivalence
Equivalence is the foundation for our system of imports. It
recognizes that an exporting country can provide an appropriate level
of sanitary protection, even though the measures employed to achieve
this protection may be different from the measures applied here at
home.
FSIS has always insisted on the opportunity to assess foreign
inspection systems before those nations can export to the United
States. This prior review is mandated by Federal Meat Inspection Act
(FMIA) and the Poultry Products Inspection Act (PPIA), which provided
that a foreign system be the same as the U.S. system before the foreign
product could be admitted. Later, that standard was adjusted to one of
equivalency when the United States adopted the Agreement on the
Application of Sanitary and Phytosanitary Measures, or SPS Agreements,
as part of the Final Act of the Uruguay Round of Multilateral Trade
Negotiations, signed in 1994.
Any country may apply to be evaluated for equivalence by submitting
a request to FSIS. While the importing country maintains the sovereign
right to maintain any level of protection that it deems appropriate to
diminish food safety hazards within its borders, a country wishing to
export to the United States still has the burden of proving that its
system is equivalent.
FSIS begins the process of determining equivalence by analyzing the
country's meat or poultry regulatory system with a document analysis to
assess whether the country has laws, regulations, and an infrastructure
to support an equivalent system.
The document review focuses on a country's practices in five risk
areas: sanitation, animal disease, slaughter and processing, residues,
and enforcement. FSIS uses the document review to ensure that the
critical points within these risk areas are addressed with respect to
those standards, activities, resources, and enforcement mechanisms
inherent in the U.S. regulatory system.
If the document review is satisfactory, the process of determining
equivalence then moves to on-site review. During an on-site review, an
FSIS audit team evaluates all the aspects of a country's inspection
program, from the headquarters of the inspection system to regional
offices and local offices, and ultimately to individual establishments
within the country and to laboratories that will be testing product
destined for the United States. We are seeking to assure that the
country's inspection program is, in fact, what the documentation
claims.
The FSIS process for announcing initial equivalence determinations
for foreign countries is transparent. When FSIS makes an initial
equivalence determination, a proposed rule is published in the Federal
Register setting forth the determination and the reasons for the
determination. After a comment period, FSIS reviews all comments
submitted on the proposal, and as appropriate, publishes a final rule
to add the country as eligible to export meat, poultry or egg products
to the United States.
Verifying Continuing Equivalence through Audits
The second part of our system to ensure the safety of FSIS-
regulated imports is to verify continuing equivalence through audits.
Once a country is determined to have a system equivalent to the United
States, that country is responsible for ensuring that all facilities
exporting to the United States employ standards equivalent to those
contained in the FMIA and PPIA. To verify that this is happening, FSIS
conducts annual audits of foreign food safety systems and procedures
through on-site visits by FSIS personnel, including certified
establishments, laboratories and a review of government controls. In
the fiscal year that has just concluded, FSIS' audit of all countries
that are eligible to export and are actively exporting to the United
States included 145 establishments, 39 laboratories, and 86 government
offices. Final audits are posted on the FSIS Website.
Verifying Continuing Equivalence through Re-inspection at the Border
Finally, the last part of our system for ensuring the safety of
FSIS-regulated imports is verifying the continuing equivalence of
foreign systems through re-inspection at the border. Every shipment of
meat, poultry, or egg products that enters the United States must be
presented to an FSIS inspector at one of the approximately 140 official
FSIS import establishments strategically located at major ocean ports
of entry and land border crossings. These initial checks for such
matters as documentation, evidence of tampering, transportation damage
and proper labeling, are to ensure that the product originated in an
approved country and was produced in an eligible establishment. This
process is assisted by FSIS' Automated Import Information System
(AIIS), a database that schedules re-inspection tasks and stores the
results of the re-inspection from each point in the process.
FSIS also performs intensive random re-inspection on approximately
10 percent of shipments of meat, poultry, and egg products. These re-
inspection tasks include product examinations, microbiological analysis
for pathogens, and/or a test for chemical residues. Acceptable products
are marked as ``inspected and passed'' and released into commerce. Non-
compliant products are rejected, marked as ``Refused Entry,'' and
either destroyed or returned to the originating country. More intensive
re-inspection is automatically applied to future shipments of product
from the foreign establishment when product fails re-inspection.
In addition to import re-inspection personnel, FSIS currently
employs twenty-three Import Surveillance Liaison Officers (ISLOs) who
are charged with identifying, tracking, and detaining ineligible,
illegal, or smuggled product. These ISLOs work with other agencies,
including Customs and Border Protection (CBP), USDA's Animal and Plant
Health Inspection Service (APHIS), the Food and Drug Administration
(FDA), and the U.S. Fish and Wildlife Service, as well as brokers and
importers at U.S. ports of entry. Access to Customs and Border
Protection's Automated Commercial Environment (ACE) database has
provided FSIS a more targeted approach to identifying and controlling
ineligible entries of amenable product closer to the entry point,
rather than after its release into commerce. In FY 2005, prior to the
FSIS' use of the ACE system, the amount of ineligible product removed
from commerce was just over 36 thousand pounds. In FY 2006, this amount
increased to 1.6 million pounds, and so far in FY 2007, over 1.9
million pounds have been identified, destroyed, or redirected to FSIS
for re-inspection.
While FSIS currently has limited access to CBP's ACE system, the
Agency and other key Federal partners are working to become fully
integrated with that system. This effort will eventually lead to a
linkage of all inspection and border control data systems among all
Federal agencies involved in imports.
In other areas, FSIS has also worked with CBP's National Targeting
Center to develop rules for targeting high-risk FSIS-regulated
shipments that enter the country. This included a two-month pilot
program in 2006 in which 3,229 shipments were screened at two separate
ports using the proposed rule sets.
Food Defense
Our three-part approach to imports is supplemented by our critical
food defense efforts to protect against accidental or intentional food
contamination.
To this end, the Agency performs vulnerability assessments for
imported food and, potentially, for food that has illegally entered the
U.S. market. These vulnerability assessments seek out ways to
strengthen our food import system. Armed with these vulnerability
assessments, the Agency conducts workshops to increase awareness of
food defense issues among our international trading partners. These
have included, in the past, the G-8 countries, Mexico, and the Asian
Pacific Economic Council. Through the G-8 Working Group, FSIS is
developing a joint exercise to prepare for the possibility of needing
to respond to an intentional food contamination incident.
FSIS inspectors engage in comprehensive and ongoing training and
education efforts in order to fulfill their role in preventing and
responding to any potential threats to the food supply. Coordinated
food defense awareness training is conducted in locations nationwide in
conjunction with our food defense partners, which are government-wide
but specifically include the Department of Homeland Security (DHS), the
Department of Health and Human Services (HHS), other USDA agencies, as
well as state and local food defense partners.
FSIS is working jointly with FDA on the continued development of
the Food Emergency Response Network (FERN) with other national, State,
and local laboratories to provide ongoing surveillance and monitoring
of food and to prepare for emergency response stemming from a food
illness outbreak, intentional contamination, or even a hoax.
FSIS is participating in a consortium of lab networks developed by
DHS. This integrated consortium ensures coordination among Federal and
State partners focused on food and agriculture. This consortium will
ensure consistency of methods development and the reporting and sharing
of lab results between Federal and State partners.
FSIS has also developed and distributed model food security plans
for use in import establishments to aid them in the development of a
Food Defense Plan. Further, while Import Inspectors conduct their
regular re-inspection at import facilities, their activities include
efforts aimed at protecting consumers from intentional attacks on the
food supply, and include facility checks to identify, among other
things, suspicious activities in product re-inspection or port areas,
evidence of product tampering, or signs that a facility's water supply
may have been compromised. The specific procedures performed change by
increasing and decreasing according to the threat level.
Interagency Working Group on Import Safety
Mr. Chairman and Members of the committee, I have discussed how the
imported food products USDA regulates are currently inspected. But USDA
is also working closely with the Interagency Working Group on Import
Safety established by the President in July.
The President formed this working group which is chaired by Health
and Human Services Secretary Mike Leavitt to ensure that we are doing
everything we can to promote the safety of imported products. The
mission is simple but critical, and that is to conduct an across-the-
board review of import safety, including reviewing safety procedures in
exporting countries, by U.S. importers, and by Federal, State, and
local governments, and to provide recommendations to the President to
promote the safety of imported products.
In September, the Working Group issued a strategic framework for
ensuring the safety of imported products. This framework outlines a
risk-based approach that includes the principles of prevention (prevent
harm in the first place); intervention (intervene when risks are
identified); and response (respond rapidly after harm has occurred).
The framework supports USDA's long-standing approach to evaluating and
verifying the ability of foreign food safety systems to ensure the
safety of meat, poultry, and egg products exported to the United
States.
The next step in advancing the framework will be the Working
Group's mid-November release of an implementation action plan. The
action plan will provide specific short- and long-term recommendations
for import safety improvements and will reflect stakeholder input
received through several outreach activities conducted over the past
two months, as well as from a public meeting held on October 1 at USDA
headquarters here in Washington.
Conclusion
At FSIS, we believe that our approach to ensuring the safety of
imported meat, poultry, and egg products is the best system in the
world. This is due to our three-part rigorous approach of determining
equivalence; the continuous evaluation of that equivalence to ensure
that it is maintained; and our vigilant surveillance of food product
entering the country.
Mr. Chairman and all Members of the Subcommittee, I would like to
thank you for this opportunity to explain the important process that
FSIS employs in protecting consumers by assuring the safety of imported
food products.
Chairman LEWIS. Thank you very much, Mr. James.
I am pleased to welcome our next witness, Steven Solomon
from the Food and Drug Administration, the Deputy Director of
the Office of Regional Operation. Welcome.
STATEMENT OF STEVEN M. SOLOMON, D.V.M., M.P.H., DEPUTY
DIRECTOR, OFFICE OF REGIONAL OPERATIONS, OFFICE OF REGULATORY
AFFAIRS, FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND
HUMAN SERVICES, ROCKVILLE, MARYLAND
Mr. SOLOMON. Thank you and good morning, Mr. Chairman and
Members of the Committee. I am Dr. Steve Solomon with the
Office of Regulatory Affairs of the U.S. Food and Drug
Administration. I'm pleased to be here with my colleagues from
other Federal agencies which share responsibilities for
imported products. Thank you for the opportunity to discuss the
important issues related to the safety of imported products.
FDA regulates everything Americans eat, except for meat,
poultry, and processed egg products, which are regulated by our
partners at the Department of Agriculture. FDA is also
responsible for human drugs and biological products, medical
devices, radiological products, and animal drugs are safe and
effective. I assure you that FDA is committed to ensuring that
the Nation's supply of food, drugs, and other FDA-regulated
products continue to be as safe as possible.
In recent years, FDA has done a great deal to detect and
prevent both unintentional and deliberate contamination of
imported products, but we continue to face significant
challenges. Recent incidents involving unsafe imported products
underscore the need to enhance our product safety strategies by
targeting out resources to projects having the potential for
causing harm public health. We're looking to accomplish this by
broadening our knowledge and applying enhanced risk-based
criteria to the entire life cycle of imported products.
Recently FDA Commissioner Andrew von Eschenbach has
appointed Dr. David Acheson to the new position of Assistant
Commissioner for Food Protection to provide leadership with
strategic and substantive food safety and food defense matters.
Dr. Acheson is coordinating development of a new strategy which
will enhance our food safety and food defense systems by
addressing the changes in global food distribution and
identifying our most critical needs.
FDA's goal is to ensure a comprehensive and robust food
safety and food defense program that focuses on a proactive
prevention strategy of building safety in from the start; risk-
based intervention to ensure that preventive controls are
effective; and rapid response when contaminated food or feed is
detected or where there is potential for harm to humans or
animals. The new food protection strategy, which we expect to
announce in the near future, will provide risk-based farm-to-
table approach using sound science that integrates food safety
and food defense efforts on both imported and domestic
products.
You've already heard about the Interagency Working Group on
Import Safety. Secretary Leavitt and Commissioner von
Eschenbach have traveled extensively throughout the United
States during the past few months, visiting ports of entry and
reviewing import operations in the field. The insights that
they gained on the review helped shape the strategic framework
that was released by the Working Group on September 10th.
The report outlined an approach that, like the food
protection strategy, is based on the organizing principles of
prevention, intervention, and response. The strategic framework
recognizes that we must find new ways to protect American
consumers and continue to improve the safety of imports. It
identifies the need to shift from the current model, that
relies on snapshots at the border to interdict unsafe products,
to the prevention focused model that identifies and targets
those steps on the life cycle of imported products where the
risk of unsafe products are greatest. This risk-based,
prevention-focused model will verify the safety of products at
those important phases of product life cycle and help ensure
that safety is built into the products before they reach our
borders.
This past Monday the Work Group held a public meeting to
receive input from stakeholders and received comment on actions
the public and private sector can take to promote the safety of
imported products. By mid-November, the Working Group will
present an action plan to the President. The plan will reflect
the public comment and lay out roadmap with short- and long-
term recommendations.
I want to touch quickly on our interactions with U.S.
Customs and Border Protections. We collaborate on a continual
basis at the Nation's port of entry and FDA's Prior Notice
Center, which is co-located with CBP's National Targeting
Center.
With respect to well-publicized issues with the safety of
imported products from China, FDA is conducting a series of
meetings with Chinese officials to negotiate a memorandum of
agreement aimed at creating a framework to help assure the
safety, quality, and effectiveness of products exported from
China to the United States. The frame is also aimed to increase
cooperation and sharing between the regulatory bodies of the
two nations with the goal of strengthening China's regulatory
process. Negotiations are ongoing with a goal of finalizing an
agreement by year's end.
Ensuring safety of imported products is a significant task,
but I want to assure you that FDA is diligently working to
efficiently and effectively use the resources and authorities
we've been provided by Congress to help protect American
consumers.
Thank you for the opportunity to discuss FDA's activities
to enhance the safety of imported products. I'd be happy to
answer any questions.
[The prepared statement of Mr. Solomon follows:]
Prepared Statement of Steven M. Solomon, DVM, MPH, Deputy Director,
Office of Regional Operations, Office of Regulatory Affairs,
Food and Drug Administration, Department of Health and Human Services,
Rockville, Maryland
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Chairman LEWIS. Thank you, Dr. Solomon.
Our next witness is from the United States Consumer Product
Safety Commission. Please welcome Marc Schoem, the Director of
Recalls and Compliance. Welcome.
STATEMENT OF MARC J. SCHOEM, DIRECTOR OF RECALLS AND
COMPLIANCE, U.S. CONSUMER PRODUCT SAFETY COMMISSION, BETHESDA,
MARYLAND
Mr. SCHOEM. Good morning, Mr. Chairman and Members of the
Committee. Thank you for the opportunity to testify.
My name is Marc Schoem. I'm the Deputy Director of the
Office of Compliance at the U.S. Consumer Product Safety
Commission. CPSC is responsible for protecting the public from
unreasonable risk of injury and death associated with more than
15,000 different consumer products. It is appropriate that the
CPSC testify before this Committee today because increasingly
the products under CPSC's jurisdiction are manufactured
overseas and imported into the United States.
CPSC's Office of Compliance conducts product recalls and
engages in other enforcement activities, and we undertake both
routine and targeted surveillance and sampling of imported
products at U.S. ports of entry.
We work in close cooperation with Customs and Border
Protection. In a memorandum of understanding signed in 1990,
the Commission and CBP established a working relationship for
the cooperative enforcement of the provisions of our statutes
dealing with imported products. This agreement recognizes a
number of activities to be taken between the two agencies. This
includes product sampling, personnel access, joint inspections,
and screening and testing of consumer products. The 1990 M.O.U.
is complemented by another one signed in 2002 to establish
procedures and guidelines for the exchange of information.
CPSC is also a participating government agency in Customs'
Automated Commercial Environment, or ACE. ACE acts as--allows
CPSC staff with necessary security clearance to analyze records
of incoming consumer products more efficiently and to target
shipments before they can be distributed into commerce. CPSC's
early experience with using the ACE system is encouraging, and
in the case center will provide us with better data about
incoming product shipments at an earlier point in the process.
This information allows us to more precisely focus our port
inspection activities on those products that might provide a
safety problem, thus allowing CPSC to be more effective.
One example of the success we have had using ACE and why we
are now incorporating ACE into our ongoing surveillance and
enforcement activities is a seizure of a large shipment of
fireworks earlier this year. We were able to investigate the
firm's import history through the ACE system and, working with
Customs and Border Protection, we flagged that company's
entries nationwide for investigation. We discovered that the
company was importing very dangerous and heavily overloaded
fireworks disguised as consumer fireworks. Not only were we
able to prevent these products from entering commerce, but the
company's owner is now facing criminal charges.
Our work with Customs is part of our multi-pronged approach
to increase surveillance and enforcement, to meet the challenge
of identifying unsafe imported products. In recent years about
2/3 of all U.S. product recalls have involved imported
products, and that number appears to be growing. The large
majority of these recalled products came from China. During the
last year, working in cooperation with Customs, we have
conducted surveillance and sample collections at numerous ports
around the country in an effort to identify unsafe products.
CPSC has targeted toys being imported where a foreign
manufacturer had been the subject of previous CPSC violation
for leaden paint violation. We've also looked at various
electrical products and recreational vehicles where we had a
concern. Additionally, CPSC is working with Customs' labs at
various ports and we're conducting training sessions with
Customs personnel so they can assist us in detecting lead in
toys. These are just a few of the most recent examples where
our joint efforts have and will continue to result in enhanced
safety for the American public. We have also been fortunate in
that we have hired a number of former Customs agents as CPSC
field investigators, and through their past Customs experience
and knowledge they have been working closely in their former
ports in an effort to strengthen our cooperation and cross-
train staff.
We, of course, recognize that the most effective deterrent
from having unsafe products brought into the U.S. is at its
source, so we are also working closely with our Chinese
government counterparts. The work plans we entered into with
the Chinese government outlined specific cooperative actions to
be taken by them and us to improve the safety of consumer
products exported from China to the United States. This is a
significant achievement, and the ACE system is an important
tool in verifying Chinese compliance with their agreement to
weed out toys with lead paint before they are shipped to the
United States.
Mr. Chairman and Committee Members, I have been with CPSC
for 33 years and, as you can see, consumer product safety is
never a completed task but always an ongoing process of
research, standards development, enforcement, public education,
and international engagement. The Commission is determined to
make certain that imported consumer products meet the same high
standards that we require of products manufactured in the
United States.
Thank you again for the opportunity to testify, and I look
forward to answering your questions.
[The prepared statement of Mr. Schoem follows:]
Prepared Statement of Marc J. Schoem, Director of Recalls and Compliance
,
U.S. Consumer Product Safety Commission, Bethesda, Maryland
Good Morning, Mr. Chairmen and Members of the Committee.
Thank you for the opportunity to testify today on the subject of
import safety. My name is Marc Schoem, and I am the Deputy Director of
the Office of Compliance and Field Operations at the U.S. Consumer
Product Safety Commission (CPSC) which is charged with protecting the
public from unreasonable risks of injury and death associated with more
than 15,000 types of consumer products. It is appropriate that the CPSC
testify before the committee today because increasingly, products under
CPSC's jurisdiction are manufactured overseas and imported into the
United States.
The CPSC is a small, independent and bipartisan Federal commission.
Since its beginnings in 1973, CPSC's work has contributed substantially
to the decline in the rates of death and injury related to the use of
consumer products. We estimate that injuries and deaths associated with
the use of these products under our jurisdiction have declined by
almost one-third over this time.
While we are proud of the agency's achievements over the years,
there is still much work to be done. In addition to ever more
technologically complex products arriving in the marketplace, and
changes in the way that consumers purchase goods and receive
information, an unprecedented surge of imports presents the agency with
new challenges. Later in my testimony, I will outline the initiatives
and methods that the CPSC is using to meet this challenge, but first I
would like to discuss CPSC's relationship with Customs and Border
Protection (CBP) which I know is of particular interest to this
Committee.
At the CPSC we accomplish our mission by executing five Federal
statutes, namely the Consumer Product Safety Act, the Federal Hazardous
Substances Act, the Flammable Fabrics Act, the Poison Prevention
Packaging Act, and the Refrigerator Safety Act.
As noted, I am the Deputy Director of CPSC's Office of Compliance
and Field Operations. In addition to conducting product recalls and
engaging in other enforcement activities, staff from my office
undertake both routine and targeted surveillance and sampling of
imported products at U.S. ports of entry, working in close cooperation
with CBP which is charged with front line responsibility at the border
for enforcing our statutes.
In a Memorandum of Understanding (MOU) signed in 1990, the CPSC and
CBP established a working relationship for the cooperative enforcement
of the provisions of our statutes dealing with imported products. This
agreement identifies a number of activities to be taken between the two
agencies including sampling, personnel access, joint inspections,
screening and testing of consumer products.
This MOU was complemented by another signed in 2002 to establish
procedures and guidelines for the exchange of information, including
access by CPSC staff to CBP's current System of Record, ACS. This
agreement also provided reimbursement to CBP for its expenses in
procuring and maintaining the necessary equipment and developing the
appropriate software and programming.
The CPSC is also a participating government agency in CBP's
Automated Commercial Environment (ACE). As you know, ACE is the new CBP
processing system which is supported by the International Trade Data
System (ITDS). ACE allows CPSC staff to analyze records of incoming
consumer products more efficiently and to identify potentially non-
complying shipments before they can get into the stream of commerce.
CPSC's early experience with using the ACE system is encouraging
and indicates that it will provide us with better data at an earlier
point in the process so that our port inspection activities can be more
precisely targeted and thus more effective.
An example of the successes we expect to have as we incorporate
further into the ACE system was a seizure conducted earlier this year
of a particularly large shipment of illegal fireworks that were being
brought into the country for the Fourth of July holiday. CPSC staff had
been able to investigate the firm's import history through the ACE
system and, working with CBP, to flag all of that particular company's
entries nationwide for investigation.
We discovered that the company was importing very dangerous and
heavily overloaded fireworks devices disguised as consumer fireworks.
The company's owner is now facing criminal charges. Sometimes
government agencies are criticized for not working together. In this
instance, CPSC, CBP, and the Bureau of Alcohol, Tobacco, Firearms and
Explosives worked together closely to identify and seize dangerous
products that had the potential to kill consumers.
Currently, additional CPSC staff are processing through appropriate
security clearances to qualify for access to ACE. As their numbers grow
and staff gains experience with the system, we expect many more good
results like this one.
Enforcement at the port works best when it is simple and straight
forward. For example, products that are subject to mandatory standards
under the CPSA must be refused admission unless they are accompanied by
a certificate of compliance. In this regard, CPSC's authorizing
committees are considering changes to our statutes, and I am hopeful
that any changes made by Congress recognize the importance of having a
certification enforcement system that is simple and straight forward to
enforce.
CPSC's cooperative work with CBP is an important part of the
increased surveillance and enforcement effort we are conducting as one
part of our multi-pronged approach to meet the challenge of assuring
the safety of imported products for American consumers. In recent
years, about two-thirds of all U.S. product recalls have been of
imported products, and that number is growing annually. The large
majority of those products are manufactured in China.
Historically, CPSC had not actively engaged in international
activities. However, in 2004, recognizing the continuous and
significant increase in the number of imported consumer products
entering the American marketplace from China, our CPSC Chairman
traveled to that country. That was the first step toward a formal
relationship between the CPSC and the General Administration of Quality
Supervision, Inspection and Quarantine (AQSIQ), our counterpart agency
in China, and it resulted in the signing of a Memorandum of
Understanding (MOU) between our two nations later that year.
In 2005, at the first U.S.-Sino Product Safety Summit, the CPSC
signed an Action Plan on Consumer Product Safety with AQSIQ. The Action
Plan outlined specific cooperative actions to be taken by CPSC and
AQSIQ to improve the safety of consumer products: training; technical
assistance; a mechanism to provide for ``urgent consultation'' when
necessary; information exchanges; and the creation of Working Groups to
address issues in four priority areas--fireworks, lighters, electrical
products and toys.
At the beginning of this year, CPSC staff identified and
communicated to our Chinese counterparts specific problems and proposed
actions to address these problems with respect to each of the four
product categories covered by the Working Groups. In May 2007, I
traveled to China with CPSC's Acting Chairman, Nancy Nord, and a
delegation of top CPSC officials for in-depth discussions of the issues
identified by this process. I was privileged to Chair two of the
Working Groups.
This hard work culminated last month at the second U.S.-Sino
Product Safety Summit held here in Washington between the CPSC and our
Chinese counterpart agency, AQSIQ. At the Summit, the CPSC reached an
important agreement with AQSIQ, under which China will immediately
implement a plan to eliminate the use of lead paint on Chinese
manufactured toys exported to the United States. The Chinese government
is working to make sure there is no lead in the paint through stepped
up inspections of U.S. destined toys and a registration system for
paint suppliers.
China also agreed to broad cooperation with the CPSC in the four
major product areas mentioned above. In each of the four work plans,
China has agreed to cooperate with the CPSC to ensure that its
producers understand and comply with U.S. safety standards for all of
their exports to the United States. The work plans provide a roadmap to
improve the safety of these products through five main avenues:
First, in cooperation with the CPSC, AQSIQ has agreed to increase
its inspections of products destined for the U.S. and to undertake
other activities to ensure that exports meet all applicable safety
standards.
Second, AQSIQ, again in full cooperation and participation with the
CPSC, will expand the knowledge and understanding of U.S. product
safety standards among Chinese manufacturers and exporters.
Third, the CPSC and AQSIQ have agreed to various technical
personnel exchanges and training activities to ensure full and mutual
understanding of our respective laws and systems, including product
testing methodologies.
Fourth, the two countries have respectively agreed to establish
regular and systematic exchanges of information about emerging product
safety issues, including monthly discussions of recall follow-up
activities and trends.
Fifth, AQSIQ has agreed to specific steps to assist the CPSC in
tracing products with identified safety problems to those Chinese firms
involved in their manufacture, distribution and export. This will
enable both of our agencies to address safety issues more quickly and
effectively as they arise.
This is a significant achievement, and while it is in China's
economic interest to enforce U.S. safety standards, CPSC staff will
nonetheless be following up to assure that the Chinese government fully
implements this commitment.
In this regard, the ACE system will be an important tool in
verifying Chinese compliance. ACE access, coupled with data research
and analysis support from CBP, has already given us the ability to
assess recent industry and Chinese claims that they were making
immediate efforts to insure that toys containing lead paint were not
being shipped. Previously, CPSC staff had limited ability to track
entries from specific foreign manufacturers.
Another prong of CPSC's initiative on import safety is our work
with the private sector, both here in the U.S. as well as in China, to
educate Chinese manufacturers and exporters not only of the content of
U.S. product safety standards, but also the importance of adhering to
those standards, including adhering to consensus or what we commonly
call ``voluntary'' standards.
As part of our plan to address this problem, the CPSC has published
the Handbook for Manufacturing Safer Consumer Products underscoring our
message that safety must be designed and built into consumer products
in conformance with safety systems planned, established and implemented
at the direction of executive management. The Handbook presents a
comprehensive systematic approach to manufacturing safe products and
has been published in Chinese and distributed throughout China.
The CPSC has also facilitated the translation of the summary
provisions of nearly 300 U.S. mandatory and voluntary consumer product
safety standards into Chinese to assist Chinese manufacturers in
understanding what U.S. product safety standards require when
manufacturing various products.
Additionally, I am one of a number of CPSC staff who have conducted
industry-specific safety seminars and retail and vendor training
seminars in China. Staff has conducted a number of other safety
training activities in China dealing with toy safety, electrical
product safety, fireworks safety and a supplier safety seminar for
retailers.
Finally, the CPSC is undertaking conversations with specific
industry groups to encourage testing and certification programs.
Mr. Chairmen, consumer product safety is never a completed task but
always an ongoing process of research, standards development,
enforcement, public education and international engagement. In that
regard, the CPSC is determined to make certain that imported consumer
products meet the same high standards that we require of products
manufactured in America and that the products American families bring
into their homes and playgrounds are safe and sound.
Thank you again for the opportunity to testify today, and I look
forward to answering your questions.
Chairman LEWIS. Thank you very much--each one of you, on
behalf of all of the Members--for your testimony.
At this time I will open the panel for question. I ask that
each Member follow their 5 minutes rule. If each witness will
respond with short and concise answers, all Members should have
an opportunity to ask questions.
Let me just start off here, and any of you may want to
respond. There are many people, citizens all around our
country, who don't have access to nor know how to use the
Internet. They've never seen a computer, and so many people
tend to rely on what they see on television, hear on the radio,
or what they read in the newspaper. But it's very hard and very
difficult for many of our citizens, for many consumers, to get
the details. What steps do you take that the details of these
recalls reach the larger community, reach the larger segment of
our society? People who live in all corners, the towns and
villages and hamlets of America?
Mr. SCHOEM. At CPSC we have a number of programs that we
offer to reach people at the grassroots level. One is our
N.S.N., our Neighborhood Safety Network, where we disseminate
information to various groups at the state and regional and
local level, and we them to then multiply--use the multiplier
effect and transfer it down to grassroots level. We also
maintain one of the original 800 toll-free numbers in addition
to our Internet site for people to access us.
Chairman LEWIS. Thank you.
Mr. SOLOMON. FDA does understand the importance of trying
to get outreach and people to have the information. We do put
information on the Internet, but we also send out press
releases, work with the press to get messages out there. We
also have public affairs specialists that work in our district
offices that work in the local, that work on the local
community level to try and get messages out, particularly for
recalls or other actions that are more locally based.
We also translate many of these, for significant actions,
into other languages to try make sure we get the message to the
right community.
Chairman LEWIS. Thank you. Yes, sir?
Mr. JAMES. At Food Safety and Inspection Service we get the
word out to the news media and state and local public health
officials to share with the public. We also issue press
releases related to recalls and post that information on the
FSIS website. We also have a hotline with an 800 number that
people can call into, 1-888-MPHOTLINE. It's open from 10:00 to
4:00 each day, and we have on our website an AskKaren.gov
question and answer area where questions can be submitted and
answered.
Chairman LEWIS. Thank you.
Mr. BALDWIN. I think that CBP will actually rely more on
the FSIS, the FDA, the CPSC to actually carry out the message
and work with them, with our public affairs office, to get the
message out. Of course, most of the contact we'll have will be
with the American consumers when they're actually entering the
country or leaving the country.
Mr. MARUYAMA. Mr. Chairman, USTR is not involved in direct
regulation. On the other hand, in terms of our trade agreements
we have a very active press operation and we try and get the
word out through media: print, radio, and TV Thank you.
Chairman LEWIS. You know, when you visit a mall or a
grocery store, I have never seen anything posted in a shopping
mall or the window of a store saying that ``this product been
recalled, beware.'' Is anything like that or do you make public
service announcement or have notice print in local newspapers
and neighborhood papers or in small town papers or community
bulletins?
Mr. SCHOEM. When the Consumer Product Safety Commission has
a recall, we develop a corrective action plan with the
recalling company that includes a number of different
notification elements: a joint press release, a recall poster
that is posted at the retail store. We work with retailers to
try to get ideal placement of those posters. Often times
they're at the service counter or in the aisle where the
product was sold, but we are working with a number of retailers
now on some new, electronic ideas that would be visually
displayed where retailers and shoppers would be able to see
them a little more clearly.
Depending upon the risk presented by the particular product
under recall, it may very well include advertisements in
newspapers, and a number of companies have done that. We also
require posting of the recall on the company's website and it's
also on CPSC's website.
Chairman LEWIS. Well, thank you very much. My time is
expired, and maybe you can respond on another Member's time. I
turn to the Subcommittee on Oversight Ranking Member, Mr.
Ramstad, for a question.
Mr. RAMSTAD. Thank you, Mr. Chairman.
Dr. Solomon, I'd like to ask you a question. I know in July
the FDA announced that by the end of this year our country and
China would sign a memorandum of understanding on food safety.
What aspects of food safety issues will this address, and to
what extent would this allow the FDA to certify the
effectiveness of the Chinese system?
Mr. SOLOMON. We are in the negotiation of process with
them. There's actually two groups within China. One was the
Chinese state FDA, which is handles medical products, and the
other is the AQSIQ, which is their General Administration of
Quality, Supervision, Inspection and Quarantine. We're looking
to get assurance from them about their inspections programs,
about their registration programs, and certification programs.
The AQSIQ is a body which controls imports and exports leaving
China. We want to get confidence in that system, build
confidence in it, by working with them, understanding what
their registration means, understanding what testing they do,
understanding what certification programs would be associated
with that, to help assure that the product coming in the United
States is safe.
Mr. RAMSTAD. Based on your preliminary discussions and any
investigations that are ongoing, are you convinced that the
process, the inspection programs, the Chinese inspection
programs, will be transparent in this process?
Mr. SOLOMON. That's part--we're in negotiations, and that's
part of the process is--we want to make sure that there's the
ability to audit and examine exactly what's going on so we
develop confidence in such a system.
Mr. RAMSTAD. Are you on schedule to sign the memorandum of
understanding on food safety by the end of the year or has that
been delayed?
Mr. SOLOMON. We're hoping that it's still on track. We had
very fruitful meetings in the past couple weeks, and we're
hoping that a delegation will be returning to the United States
shortly.
Mr. RAMSTAD. I just think for the safety, and I'm sure you
agree, safety and confidence of the American consumers, they
certainly deserves nothing less than the certification that the
Chinese system is effective, given the imports from China.
I want to ask another question of either Dr. Solomon or Dr.
James or for that matter any of the distinguished panelists
before us. Have any of your agencies ever had to lower safety
standards because of Free Trade Agreements to which the United
States is a party? Have you ever been in that situation?
Mr. SOLOMON. FDA is a regulatory public health agency and
we've never been in that situation.
Mr. RAMSTAD. Dr. James?
Mr. JAMES. The Food Safety and Inspection Service is also a
public health regulatory agency; we have not had to reduce our
food safety standards through any Free Trade Agreement. The
Free Trade Agreements have always protected our authority to
maintain our own high standards.
Mr. RAMSTAD. Any other Members to testify?
Mr. SCHOEM. To my knowledge, CPSC has never reduced any of
its standards for a trade issue.
Mr. RAMSTAD. Thank you very much. That confirms what many
of us believe and believe to be the case, and I appreciate it--
your going on the record, and I yield back the balance of my
time.
Chairman LEWIS. Thank you. Now I turn to the Chairman of
the Subcommittee on Trade, Mr. Levin, for his questions.
Chairman LEVIN. Thank you very much and, Mr. Ramstad, I'm
glad you asked that question, and I think the answer is the
correct one. But I must say, if people are watching this, I
don't think our constituents have received from you any sense
of urgency. I'd like to say to our distinguished USTR
representative just the following if I might, Mr. Maruyama.
On page three you say, ``So, if we are to move away from
science and risk-based regulation, and erect protectionist
barriers to trade unchecked by WTO and FTA rules in the guise
of consumer safety, U.S. exports would be highly vulnerable to
mirror restrictions, and some of our trading partners would be
only too happy to oblige.'' I think in a sense that's for straw
man for this hearing, if I might say so. There's nobody
suggesting that we move away from science-based procedures, no
one.
In fact, the question among our constituents is this: are
science-based procedures being followed? When they see all of
these recalls and this bevy of activity in terms of recalls,
they wonder, ``Where is the science and where is it being
applied?'' So, let me just ask, as I understand it there was a
2003 memorandum between FDA and CBP You know we use these
initials, and maybe we should not. FDA, I guess I should ask
Dr. Solomon this, agreed to provide appropriate training for
commissioned CBP officers to allow them to conduct FDA
examinations and investigations. How many of these 8,000
officers have actually received training? Do you know?
Mr. SOLOMON. All the officers have received a training
program from FDA That specific commissioning authority was
granted by Congress under the Bioterrorism Act, and the
specific provisions of that agreement related to bioterrorism
in significant imports that may come in, where we need to have
enhanced capacity by using CBP.
Chairman LEVIN. All of them have received their training?
Mr. SOLOMON. My understanding is that they have been
trained on understanding how to do FDA examinations and
sampling if that capacity was needed.
Chairman LEVIN. I'm not sure what that means. Why don't you
submit for the record a complete statement about that?
Mr. SOLOMON. We'd be glad to.
Chairman LEVIN. So, let me ask you, each of you, USTR
perhaps isn't involved with this, and I know it may not be
possible for you to answer but try: do you and your agencies
have enough personnel to carry out adequate functions in terms
of safety of products and agricultural goods? Would you tell us
today that there is adequate personnel in each of your agencies
to do this?
Mr. SOLOMON. I guess I'll start. In the plans I highlighted
during my testimony, which is a food protection strategy, and
also in the Import Working Group that's being led by the
Secretary, there's going to be further discussions about what's
needed to implement these activities. So I would suggest that
that would be the venue that would be used to be able to talk
further about resources.
Chairman LEVIN. What are you advising? I mean, everybody's
kind of using the inter-agency function as a rationale for not
saying very much as to what will come out. What are you
advising the Interagency Committee as to the adequacy of
personnel?
Mr. SOLOMON. Our position is personnel is one element of
the program, but the other elements of the program include a
lot of other activities that need to be used to enhance import
safety. This includes better risk-based targeting products,
using the whole life cycle, information technology, the whole
gamut of information----
Chairman LEVIN. Personnel assistance----
Mr. SOLOMON. One issue.
Chairman LEVIN. Okay, on that one issue is there adequate
personnel today?
Mr. SOLOMON. If we had more personnel, we could do more
activities.
Chairman LEVIN. My time's up. Maybe you'd like that you
don't have to answer it. Anybody want to in thirty seconds like
to say yes or no? Yes.
Mr. BALDWIN. I would like to offer one thought. You had
mentioned the Bioterrorism Act and the commissioning of 8,000
officers in support of FDA. I think our records show that as of
September 2007 over 9,900 CBP officers have been trained and I
think that counts for attrition and new hires since the B.T.A.
So, I think we're well on pace in answering your first
question.
Second, I think that also points out, though, a critical
component that I know is being discussed in the Interagency
Work Group, and that is not necessarily focusing so much on
plussing up resources, but leveraging existing resources across
the Agency. I would offer that there's an important distinction
between coordination among agencies and collaboration among
agencies, so that the B.T.A. effort, where you actually have
CBP officers commissioned to do FDA work, has turned out to be
a very positive experience. I'm hoping we can play off of that.
Chairman LEVIN. Okay, my time is up.
Chairman LEWIS. Thank you, Mr. Levin. Now I turn to the
Subcommittee on Trade Ranking Member, Mr. Herger, for his
question.
Mr. HERGER. Thank you, Mr. Lewis. For Mr. Maruyama and then
perhaps Dr. Solomon, a number of bills introduced require or
encourage the Administration to establish equivalency
agreements with foreign governments before allowing foreign
producers to export to the United States. Could you tell me,
how necessary is it for the United States to establish
equivalency agreements on food safety with our major trading
partners? I'm referring to other than our existing agreements
on meat, poultry, and eggs.
Mr. MARUYAMA. Well, I think this question is primarily for
USDA and FDA, but our Free Trade Agreements allow us to request
equivalency from foreign governments. So, far that's been very
much of a, I would say, one-way proposition. We used it to get
access to a lot of markets in Latin America and other countries
where we've gotten FTA's. They've had somewhat greater
difficulty establishing equivalency in our markets. We can ask
for equivalency. The USDA system for meat, poultry, and eggs is
built around equivalency. The FDA has taken a somewhat
different approach.
Mr. HERGER. Dr. Solomon?
Mr. SOLOMON. Thank you for the question. As you're probably
aware, FSIS regulates around 20 percent of the food supply and
FDA has around 80 percent of the food supply. Equivalency is a
complex issue when you try and talk about all the different
products that FDA regulates. The important question is ensuring
the safety coming in. I'm not certain that equivalency is the
only way to get that, because many of our trading partners that
are willing to beat FDA standards, that are expected to come in
and provide certification to those standards, which may not
be--no equivalency for what they're doing domestically in those
countries.
Mr. HERGER. Okay, Dr. Solomon, just--H.R. 3610 would
restrict imports of food and agricultural products only to
those ports that have an FDA lab. Could you tell me, is such a
restriction necessary to ensure for safety of the U.S. imports
and what would the practical effect be on trade?
Mr. SOLOMON. FDA currently has 13 laboratories. Not all of
those laboratories are located at ports of entry. It's not an
essential requirement to do a laboratory analysis on every
entry. The risk-based criteria that are being talked about by
the President's Working Group and the Food Protection Plan
involves a number of strategies, and sampling is only one of
those aspects of it. In today's era, when we need to collect
samples, those samples can be collected from many locations,
sent by delivery systems and sent to laboratories, the critical
piece of the laboratory piece is having the capacity to run the
samples, trying to run the samples using the most rapid
techniques and using the right standards and appropriate
methodologies.
Mr. HERGER. Dr. James, would you like to comment on this?
Mr. JAMES. FSIS has 140 import houses in proximity to
seaports and border crossings on our coasts and on the borders
with Mexico and Canada. They represent about 33 major ports of
entry through which meat and poultry enter, and we have three
laboratories: one in Athens, Georgia; one in St. Louis,
Missouri; one in Alameda, California, and our history has
demonstrated that this system and arrangement has worked quite
well for ensuring the food safety mission that we have.
Mr. HERGER. Thank you. Thank you, Mr. Chairman.
Chairman LEWIS. Thank you very much. I now turn to Mr.
Pascrell for his question.
Mr. PASCRELL. Thank you, Mr. Chairman. Mr. Chairman, I ask
these questions in honor of Eduardo Arias, the gentleman of
Panama who discovered in tube of toothpaste from where he was
working that the toothpaste contained diethylene glycol, which
is used in antifreeze, and would set off a worldwide review of
what is happening. Mr. Chairman, the road to hell is paved with
antonyms all over the place.
My first question is with Mr. Solomon. Mr. Solomon, in the
last panel today Cal Dooley will testify. He's one of the
persons that will be testifying in the next panel. He said the
following, and I would like your reaction.
He said, ``The FDA resources have not kept pace with the
demand posed by rising imports and current food safety
challenges. To meet these needs, Congress must provide new
funds to dramatically improve FDA's analytical testing
capabilities, to increase and better target inspections
conducted by FDA, to obtain realtime test results, and to
enhance communications during crisis events. With additional
resource that are well deployed, FDA should be much better
positioned to find any remaining needles before they cross the
border and enter into U.S. commerce. Would you give me a brief
response to that, please?''
Mr. SOLOMON. Those comments are very much in line with the
President's Import Work Group. We need to use the best science,
we need to target inspections at the best locations----
Mr. PASCRELL. But what about the part about more resources
so you can do your job?
Mr. SOLOMON. That report highlights that among other
things. Resources is a critical issue.
Mr. PASCRELL. So, you believe there should be more
resources?
Mr. SOLOMON. The--resources is one of the answers----
Mr. PASCRELL. Why haven't there been more resources before
this report? We just discovered that FDA doesn't have enough
people and enough resources to do its job? Is that what you're
telling us?
Mr. SOLOMON. We've, using risk-based approaches to try and
target the best products to ensure the safety----
Mr. PASCRELL. Mr. Solomon, let's use an acronym for a
second. I asked--the Food Safety Inspector's System, and Import
Safety Inspectors are therefore--a 4 billion, there's only--how
many inspectors are there to inspect 4 billion pounds of
imported meat? How many inspectors?
Mr. SOLOMON. That's for FSIS, not USDA.
Mr. PASCRELL. Mr.--Dr. James.
Mr. JAMES. We have about 77 import inspectors and about 23
import surveillance liaison officers who are responsible for
performing this part of our food safety----
Mr. PASCRELL. So, you have 77 inspectors at points of entry
throughout the entire country, sir?
Mr. JAMES. Yes, sir.
Mr. PASCRELL. How does this compare with the number 5 or 10
years ago?
Mr. JAMES. It is approximately the same.
Mr. PASCRELL. How much more meat do we import than we did 5
years ago, 10 years ago?
Mr. JAMES. The levels of imported product have remained
fairly stable over the last few years.
Mr. PASCRELL. Doctor--the last few years?
Mr. JAMES. Yes, sir. I can't go back 5 years in my head.
Mr. PASCRELL. Mr. Solomon, why is the FDA relying on 8,000
inspectors, officers, to conduct its examinations? Does this
mean that the FDA has some staffing shortfalls? Do you think
overall you're adequately staffed in all realms to help
maximize the safety of the American consumer? Do you believe
there are enough inspectors out there to protect the American
consumer today?
Mr. SOLOMON. The Administration has asked in Fiscal Year
2008 for additional fundings in the area of 6.5----
Mr. PASCRELL. So, you don't think there are enough
inspectors out there to protect the American consumer?
Mr. SOLOMON. Part of those funds would go for more
inspectors that we requested, as well as the other, needed
improvements in import safety.
Mr. PASCRELL. Mr. Chairman, thank you for holding this
Committee today. The American people deserve better than what
they've been getting, not only from the President, but from the
Congress of the United States. The funding is inadequate, the
number of inspectors is inadequate. This is an absolute
disgrace, that we have to rely on people who don't even work
for us to bring to our attention what's in our product that's
coming into this country. That's unacceptable, and I don't
sense urgency here. I don't sense urgency, so we'll have
another Work Study Group, I'm sure. I yield back.
Chairman LEWIS. Thank you very much for your questions. Now
we recognize the gentleman from New York, Mr. Reynolds, for his
question.
Mr. REYNOLDS. I thank the Chairman and I thank also
Chairman Levin for holding the hearing, along with our Ranking
Members. I've listened very carefully to some of my colleagues
today, but I have an interest in bigger picture.
As we refer to the Working Group and as admirable that
Secretary Leavitt has tried to convene this, I just look at how
much you've handed off to each other, haven't answered the
question. I mean, we've got a tremendous opportunity here.
We're using two Subcommittees of Ways and Means to convene a
hearing that just has five from the government. We have 12
departments, 34 governmental agencies, and 20 Committees within
the Congress that have oversight.
While we're addressing that, the stats are so clear, the
growth of imports--and we're reading our concerns on whether it
be food, or most recently toys and Fisher-Price, headquartered,
which is a Mattel company, in my region of the State of New
York--it brings us back to looking at how are we going to make,
first, the government have this Working Group have a common
approach of how we standardize what our expectation and
performance will be on imports, before just start throwing cash
at fixing the problem in each of the 34 governmental agencies
and 12 departments?
Second, the one of the things I've asked the Speaker of the
House to look at is, in the spirit of what we've done of her
desire among Members of Congress to look at a select Committee
in Global Warming--I think with this type of challenge we've
had here, I call upon her to convene some way, that we have 20
Committees and Subcommittees of the Congress on a relatively
simple page of trying to do our job both in oversight and then
trying to make some decisions as to what the investment needs
to be for the government to do its job.
We see how the expertise in each of the five of you is, you
defer whatever our question is to your particular department
and how your agency chooses to address import safety. While the
Working Group has been an umbrella to say we're going to
advance to tie this down, I think that part of what the
Congress needs to do is work at achieving some comprehensive
collaboration that works in what our public policy should be in
a uniformity of import safety, and also begin to get our own
house in order--how we actually have some oversight
jurisdiction on it, because it spreads across 20 different
Committees of the Congress.
And--one of the things maybe one of you may want to take on
is, do you truly expect the Working Group to be the cure-all
for advising both the coordination of the Administration on
import safety, as well as, how we can do our job both in
oversight or looking at some codification of things the
Congress may have to do to better help you do your job, in
addition to any consideration of taxpayer money? Anybody want
to take that?
[No response.]
Your silence is deafening. Just, as I say, as a Republican
I made this very clear, that if you think this is a partisan
problem you're out of your mind. I hope you'll go back to your
respective agencies and have--just one quarter of you are here
on import safety. There's three quarters of the government not
here that has oversight of this and responsibilities to do your
job. We need both in the wakeup call, I think, of the Congress
that we have to have a comprehensive approach. We need to see
results of a Working Groups that's providing direction for both
the government and what we need from this Congress.
I thank the gentleman.
Chairman LEWIS. Thank you very much. Mr. Becerra of
California is now recognized for his question.
Mr. BECERRA. Thank you, Mr. Chairman, and thank you to the
witnesses. We appreciate your testimony.
Let me concur with the gentleman from New York and his
comments. Obviously, we want to make sure that when we give you
a dollar it will be used efficiently, and so perhaps the most
important thing is to have this Working Group report back
quickly to us and tell us how we can extract as much efficiency
out of all of these agencies that are charged with this
oversight capacity to provide the safety and well-being of
Americans as we continue in this mode of importing and
exporting food.
I think it's worth noting that in a 10-year period from
1996 to 2006 we doubled the number of imports of agricultural
and seafood products into this country, from some $39 billion
to close to $78 billion. Today, 92 percent of all fresh and
frozen seafood consumer by Americans in this country is
imported. Today, 52 percent of all the grapes that we eat in
this country are imported, and it would surprise folks from the
State of Washington to know that today 75 percent of all the
apple juice we drink here in America comes from a different
country.
If that's the case, then we have to make sure that we're
getting product that is grown as safely as we would expect to
grow it for our own people in this country. So I hope you took
some notes as Congressman Reynolds as speaking, because this is
not a partisan issue. This is a--clearly an issue that must be
addressed ``bipartisanly'', and so we do need to find out what
we can do with all of your agencies and the moneys that you're
getting and the people you have in place.
I would urge you to make sure that when you come back to us
you've told us what you've done to your budget and to your
operating procedures that make it very clear that you don't
take this as just another day's work on the job, that you're
going to do something differently. Because there is a problem.
The President has identified it as a problem, we here in
Congress have, I know you have, and so have the American
public. So what we need to see is that you all come back with
some serious changes to the way you operate.
I do believe you need more resources. Sometimes you're
strapped by the economic considerations that the Office of
Management and Budget places on you, but I do believe you have
to be serious with this issue and deal with it in a serious way
with OMB. So, when OMB says, ``You've got to meet a budget,''
you're letting OMB know if you can, and if you can't you have
to be honest with them and say, ``With the budget you're
telling us we have to live under, we will not be able to
provide the American people with the safety you expect.''
So, when you come back to us with a number, and we will ask
you what your 2008 request is, this ``2008 request'' is for
your budget, and specifically with those issues that deal with
inspection and safety, please make sure you can justify what
you've requested. Because you've been put on notice here, I
think, today, that we will want to know that you're doing
things differently.
So I don't really have a question because I think the
questions have somewhat been asked. I don't want to put you on
the spot to tell me how much more you're going to put down for
more resources to do inspections, how many more personnel
you're going to hire tomorrow--we'll give you that time. We
don't need this to become a witch hunt. We don't need this to
become an issue where we try to claim victory for getting some
success or point fingers to where it didn't happen, but please
get back to us. Show us that you've taken seriously what the
American public has told us, and that is that we've got to
ensure that what they're going to eat, what our kids are going
to play with, will be safe. So I hope that that charge is
something that you all will continue to work on as diligently
as you can, and we very much thank you for your time here.
Mr. Chairman, with that I will yield back unless anyone
else on the panel has any particular questions or comments.
[No response.]
Thank you, Mr. Chairman.
Chairman LEWIS. Thank you very much. The gentleman from
Missouri, Mr. Hulshof, is now recognized.
Mr. HULSHOF. Thank you, Mr. Chairman. I know we're in the
midst of votes, and so I'll try to yield back some time.
I applaud the passion from the gentleman from New Jersey
who spoke earlier. I know the prime focus of this hearing has
been centering on--centered on food and product safety because
of the very high-profile recalls we've seen of late. For the
life of me, Mr. Chairman, I can't understand--and I'm not here
to detonate a bomb here among us, but for the life of me I
can't understand why a majority of Congress is hell bent on
allowing the importation of pharmaceuticals. Dumbing down or
allowing the easy importation of drugs that could be
counterfeited, I think that should be a red flag for all of us,
and yet it seems we are hell bent--``we'' collectively, because
I don't support it--hell bent on Congress trying to allow the
importation of drugs from places across the planet. That's just
an editorial comment, sir.
Dr. James, I'm tempted to inquire about the USDA's position
about equivalency of inspection systems within interstate
commerce, because I know that's been the subject of some
interesting discussion of late, but that's not the subject of
this hearing. But I do want to inquire--there are annual audits
of foreign food safety systems, I think that's in your
testimony, correct?
Mr. JAMES. That is correct.
Mr. HULSHOF. So, once a year?
Mr. JAMES. Yes, sir. The regular routine is to go once a
year.
Mr. HULSHOF. Then on-site visits--I assume these are
announced visits by USDA into another country, to allow you on
the premises and then do you correct your battery of tests? Is
that a fair assessment?
Mr. JAMES. Yes, sir. That is correct. We arrange to have
our people met and conducted on their assessments of plants,
laboratories, and government oversight, through audits and
visual observations of the systems in place and through
checking of records back over a period of time.
Mr. HULSHOF. Is there any concern on USDA's part that some
foreign entity, knowing of the impending inspection, suddenly--
while they may have been cutting corners for the previous nine
months, in the three months coming up to the inspection that
suddenly they try to get their act in order? Is there anything
that we should be--that you're concerned about that we should
be concerned about? Or are annual audits sufficient in USDA's
view?
Mr. JAMES. We believe our annual audits are an important
part of the entire system, which as I described earlier
consists of an initial determination of equivalence, the annual
audits, and then the port of entry re-inspections that we
perform. Altogether, they get the job done. We believe our
auditors are sufficiently trained to review oversight and
records to review whether or not what they are seeing while
they are on-site is reflective of the history of those plants.
Mr. HULSHOF. We're really running short on time on the
floor. Mr. Chairman, I appreciate it. Final quick comment: Mr.
Maruyama, thank you for including in your statement how easy it
is, and I'm paraphrasing but it's on page four for people to
look at, how easy it is for foreign countries to lock out our
farm exports through ``spurious sanitary and phytosanitary
measures, just as they have cynically restricted,'' again, your
terms and I agree with this, by the way, ``U.S. manufactured
goods through protectionist barriers dressed up as safety and
regulatory standards.''
Finally, Mr. Baldwin, perhaps you may want to do this in
written form, again because our time is short on the floor. ``A
later witness is concerned about port chopping.'' That is--I
mean, can you give me a 10-second--is that a concern from your
point of view?
Mr. BALDWIN. I would say that's always a top concern,
particularly on issues like seafood. I know that we were
immediately concerned that, because there were restrictions
being imposed on one country of origin, that there might be
other opportunities for transshipment, either through a foreign
port of export or a U.S. port of import.
Mr. HULSHOF. I think what I'd like to do, Mr. Chairman,
maybe is follow up with a written inquiry again, because time
is drawing short. But I appreciate that short answer, and thank
you for the time, Mr. Chairman.
Chairman LEWIS. I thank the gentleman. As you well know, we
have a series of votes on the floor and I will suggest, I don't
think any of the Members here have any questions at this time,
maybe dismiss. Thank you for your testimony, thank you for
taking the time to be here.
We're going to recess the Committee until after the vote. I
believe we have about five, 5 minutes vote--six votes. So, it
could be a little time, and we ask that the next panel be
patient.
[Recess.]
Chairman LEWIS. The hearing will now resume. Let me thank
members of this panel for being so patient. Sorry that we had
to take so much time to cast a few votes. I really thank you
for taking the time to remain.
Now we will here from our second panel witnesses. I ask
that each of you limit your testimony to 5 minutes. Without
objection, your entire statement will be included in the
record. I will have all of the witnesses to give their
statements and then the Members will ask questions of the
panel.
It is now my pleasure to introduce our first witness, Mark
Berman, the Chairman and chief executive officer of Rockland
Industries.
I thank you for being here, Mr. Berman.
STATEMENT OF MARK R. BERMAN, CHAIRMAN, ROCKLAND INDUSTRIES,
INC., BALTIMORE, MARYLAND
Mr. BERMAN. Thank you. Thank you, Chairman Lewis and Levin
and that Member of the Subcommittee for the opportunity to
testify about the safety of imported textiles. My name is Mark
Berman. I am CEO of Rockland Industries, one of the remaining
textile manufacturers in the U.S. I am testifying on behalf of
Rockland, but also as a concerned citizen about an under-
publicized and unregulated public health risk. That risk comes
from the hazardous chemical formaldehyde, found at dangerous
levels in textiles imported from China. Formaldehyde can cause
cancer, serious respiratory disease and other health problems.
Although you may not recognize Rockland, you have probably
come into contact with some of our products. We make the
blackout window covering fabrics that are found in almost every
hotel and motel room in the U.S. In fact, we export those
products to 90 countries.
Because of the time limit, I can only touch on some major
points, but there is a more complete discussion in my written
submission.
Most textiles are full of chemicals. They give fabrics
color, permanent press, fire retardancy and many other
features. A textile trade group has identified 146 dangerous
chemicals used in textile manufacturing that are subject to
regulation someplace in the world. One of the worst is
formaldehyde.
Only three years ago, the international cancer research
agency found formaldehyde to be a human carcinogen, raising its
determination from its previous evaluation is only possible.
The EPA and OSHA also recognize it as a carcinogen. Exposure
can cause allergy symptoms and repeated exposures can cause
asthma. Children are more susceptible than adults. This is the
stuff in the FEMA trailers and that has poisoned the pet food.
It is, however, a very useful chemical. Formaldehyde-
containing resins impart permanent press, shrinkage control and
vibrant colors to apparel fabrics and home use textiles. In the
case of coated fabrics like our blackout, formaldehyde produces
durability.
The formaldehyde content of textiles is not regulated in
the U.S. However, since 1988, OSHA has regulated formaldehyde
exposure in the work place, including drapery sewing rooms,
hotel rooms, warehouses and retail stores. OSHA requires that
products containing 1,000 parts per million or more have a
health warning label including the words, potential cancer
hazard.
As a result of the OSHA regs, new chemicals were formulated
with much lower levels of formaldehyde. The amount of
formaldehyde in U.S.-made fabrics fell dramatically. Since
1988, formaldehyde in textiles has been off the radar screen in
the U.S. The current generations of buyers who Rockland deals
with at the major retail chains are not aware of formaldehyde
as an issue. They are interested in price. The old, high-
formaldehyde chemical technology still used in China is
significantly cheaper than low-level formaldehyde chemicals.
We first became aware of safety problems with Chinese
textiles in the international market. Since 2003, we have
tested every sample of foreign-made blackout we could obtain.
However, it was not in March of this year that we began to see
these products in the U.S. market.
Of the 44 different products we had tested at an
independent lab, 24 or 55 percent had formaldehyde levels high
enough to require the OSHA cancer warning label, with amounts
ranging to over 3,000 parts per million. A summary of the test
results is in my written testimony.
While most of the samples were made in China, Pakistan,
Turkey and Poland also produce dangerous textiles. OSHA work
place and EPA environmental regulation of formaldehyde does not
protect consumers against exposure from imported fabrics. This
problem is one for the Consumer Product Safety Commission under
the Federal Hazardous Substances Act.
Currently, the CPSC requires warning labels on household
products containing 10,000 parts per million or more of
formaldehyde. Textiles do not contain that amount of
formaldehyde.
In 1973, the CPSC took the position that formaldehyde in
textiles was not covered by the Hazardous Substances Act.
However, the 10,000 part per million standard and CPSC position
was set before the medical research connecting formaldehyde
with cancer, or the growing international consensus among
developed nations and, ironically, China, that direct
regulation of formaldehyde content in textiles is necessary to
protect the health of their citizens.
At least eight foreign countries, including China, have
adopted specific limits. They are summarized in my written
testimony.
Formaldehyde is undeniably dangerous, yet consumer exposure
coming from apparel and home fabrics is unregulated. Limits on
the formaldehyde content of textiles are needed. The structure
for regulating and enforcement is already in place through the
CPSC and the Hazardous Substances Act. Limits could be set
through appropriate rulemaking.
Customs could require importers to submit samples for
testing at Customs labs before the containers arrived, with the
importers required to pay for the tests. Industry self-
regulation through voluntary standards would not effectively
protect the public. I know firsthand the pressures that the big
retailers put on their suppliers for ever lower prices.
Considering the major cost advantage of using high
formaldehyde-level chemicals, I wouldn't want my family's
safety to be at the discretion of some unknown supplier being
squeezed by a retailer.
Thank you.
[The prepared statement of Mr. Berman follows:]
Prepared Statement of Mark R. Berman, Chairman and Chief
Executive Officer, Rockland Industries, Inc., Baltimore, Maryland
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Chairman LEWIS. Our next witness is from the Consumers
Union. I am pleased to welcome Jean Halloran, the director of
food policy initiatives. Thank you for being here.
STATEMENT OF JEAN HALLORAN, DIRECTOR OF FOOD POLICY
INITIATIVES, CONSUMERS UNION, YONKERS, NEW YORK
Ms. HALLORAN. Thank you for inviting me and for this
opportunity to testify on what has become a serious crisis in
import safety.
Almost daily, we are hearing new reports of safety problems
with imported food, toys and other products, including pet food
from China, seafood from China, and 20 million toys
manufactured in China. Just last week, one million cribs made
in China were recalled due to design and construction defects
that caused babies to strangle.
This raises an obvious question of how did we get into this
situation? We see two causes to the problem. One is that two of
the most important Federal agencies that the public relies on
to ensure that everything in our marketplace is safe, the Food
and Drug Administration and the Consumer Product Safety
Commission, have not kept up with globalization. In fact, quite
the opposite.
Congress has repeatedly cut the budget of the CPSC so that
it now has half the employees that it had when it opened its
doors in 1973. It only has 15 inspectors to police the millions
of toys coming into the country and, according to the New York
Times, has exactly one full-time toy tester.
The FDA is equally hamstrung. Today, it inspects less than
1 percent of the food imports entering the country and is
present at less than half of the over 300 ports where food can
enter. This has led to a phenomenon known as port shopping. If,
in fact, you have a product that doesn't make it through an FDA
inspector, you can try another port, where perhaps nobody will
be watching.
In the absence of adequate FDA and CPSC capacity, Customs
and Border Protection becomes the fall-back consumer protection
agency at the borders. However, as the previous speakers noted,
they have problems coordinating with other agencies and their
databases cannot connect with, for example, USDA's database.
Overall, Consumers Union recommends that Congress consider
a number of steps to address these problems. It should man date
a major increase in the border inspection staffs, which could
be paid for through user fees on imports, for CPSC and FDA
products. It should require FDA and CPSC to establish federally
supervised systems for independent third party certification of
imports to certify them to U.S. standards. It should give USDA
and FDA explicit authority to recall contaminated food and it
should end the USDA policy of secrecy about the identity of
retail out lets involved in meat recalls. This is especially a
problem and one which could address the fact that many people
who don't have computers need to know about recalls.
A rule to do this is currently stuck at OMB as far as I
have been informed.
They should strengthen FDA and CPSC overall. If FDA only
inspects U.S. facilities once every 10 years, in the United
States, then it's difficult to demand more of the Chinese.
Especially under WTO rules.
The second major cause of our import problems lies in our
trade policy. I also sit on a State Department advisory
Committee on trade. For many years, I have seen that our trade
policy proceeds with blinders on toward just one goal: That of
gaining access for U.S. companies to foreign markets, with
little consideration of the impact on the domestic marketplace.
Our trade policy has to take a more holistic approach. One
change that would be important would be to pass H.R. 3204,
which would open up the trade Committees, the advisory
Committees that advise the U.S. Trade Representative.
Another would be that Congress should examine for its
pending trade agreements and delete provisions like Chapter 11.
Other is that the State Department, the USTR and Department
of Agriculture should be directed to give attention to
counterfeiting problems not just of CDs, but on safety issues
like counterfeiting of the Underwriters Laboratory logo.
Congress should also ensure that, where trade negotiators
seek harmonization of standards, they always seek to harmonize
up and not down. In the case of mad cow disease, we have tried
to persuade Japan to harmonize down, rather than the other way
around.
Congress should investigate whether WTO rules may hamper
the ability of Federal agencies to protect the public and, if
so, address the problem. For example, just the kind of risk-
based enforcement to FDA did on seafood could be challenged
because trade rules prohibit countries from imposing stricter
standards on one country than another.
Thank you very much.
[The prepared statement of Ms. Halloran follows:]
Prepared Statement of Jean Halloran, Director of
Food Policy Initiatives, Consumers Union, Yonkers, New York
Thank you for the opportunity to testify today on what has become a
serious crisis in import safety. My name is Jean Halloran and I am
Director of Food Policy Initiatives for Consumers Union, non-profit
publisher of Consumer Reports.
Almost daily, we are hearing new reports of safety problems with
imported food, toys, cribs and other consumer products. In the spring,
we discovered that pet food imported from China contained wheat flour
that was contaminated with melamine. According to one veterinarian
website, thousands of pets may have died as a result.\1\ In June, the
FDA put five types of farmed-raised fish and seafood from China under a
``detain and test'' order, due to repeated findings that the fish
contained chemicals banned from seafood in the United States.\2\
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\1\ Dahlberg, Carrie Peyton, ``Vets Survey: Pet Deaths Have
Soared'' Sacramento Bee, April 10, 2007.
\2\ FDA News, ``FDA Detains Imports of Farm-Raised Chinese Seafood;
Products Have Repeatedly Contained Potentially Harmful Residues,'' June
28, 2007.
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Over the summer, more than 20 million toys manufactured in China
were recalled because of lead paint and other hazards, despite the fact
that lead paint was banned on toys in the U.S. thirty years ago.\3\
Just last week, one million cribs made in China were recalled due to
design and construction defects that could cause babies to strangle.
The cribs are believed responsible for the deaths of two infants.\4\
---------------------------------------------------------------------------
\3\ Newman, Andrew Adam, ``What's a Parent to Do?'' The New York
Times, September 29, 2007, p. C1.
\4\ News from CPSC, ``About 1 Million Simplicity Cribs Recalled Due
To Failures Resulting in Infant Deaths'', September 21, 2007.
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This raises the obvious question, how did we get in this situation?
Why do we suddenly seem to be inundated with unsafe and substandard
products? Many of the most well publicized examples are coming from
China, but they are not the only source. In 2003, 555 people became
sick and at least 3 died from hepatitis A in green onions imported from
Mexico.\5\ There have also been recalls of millions of pieces of
children's jewelry made in India that contained large amounts of
lead.\6\
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\5\ V Dato et al., Hepatitis A Outbreak Associated with Green
Onions at a Restaurant--Monaca, Pennsylvania, 2003, 52 MMWR 1155-57
(2003)
\6\ News from CPSC, ``CPSC Announces Recall of Metal Toy Jewelry
Sold in Vending Machines,'' March 1, 2006.
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We see two causes of the problem. One is that two of the most
important Federal agencies that the public relies on to ensure that
everything in our marketplace is safe--the Food and Drug Administration
and the Consumer Product Safety Commission--have not kept up with the
globalization of the marketplace. In fact, while new demands on their
expertise have arisen, these agencies have experienced budget cutbacks.
In addition, Customs and Border Protection, which also plays an
extremely important role, is not being utilized in the best possible
way to address threats to consumer safety.
The second problem lies with the direction that Congress and the
Executive Branch have given to our trade policy, which has largely
ignored the problems of unsafe and hazardous imported products. I would
like to discuss both of these problems and how we can remedy them.
First, in recent years, imports have skyrocketed, especially from
China. The value of all imports increased by 67 percent between 2000
and 2006.\7\ This has proceeded to such an extent that now 80 percent
of all toys sold in the United States are imported from China.\8\
Likewise, 83 percent of the seafood we eat is imported, 21 percent of
that total from China, much of the rest from other developing countries
in Asia and Latin America.\9\ Of all the food we consume, 13 percent is
imported.\10\
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\7\ Interagency Working Group on Import Safety, Protecting American
Consumers Every Step of the Way, September 10, 2007.
\8\ Wenske, Paul, ``Toy recalls fuel criticism of consumer safety
agency,'' Kansas City Star, August 15, 2007.
\9\ Food and Water Watch, Import Alert, July 2007, available at
www.foodandwaterwatch.org.
\10\ Bridges, A. ``Imported food rarely inspected,'' USA Today,
April 16, 2007.
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While these imports pose new safety challenges to both importers
and all regulatory agencies, FDA and CPSC, in particular, have not kept
pace with this new challenge. In fact, quite the opposite. Congress has
repeatedly cut the budget of the CPSC so that it now has half the
number of employees it had when it opened in 1978. It now has 15
inspectors to police the millions of toys and consumer products coming
into the country at hundreds of entry points. And, according to the New
York Times, it has only one full-time toy tester, named Bob.\11\
---------------------------------------------------------------------------
\11\ Lipton, Eric, ``Safety Agency Faces Scrutiny Amid Changes'',
New York Times, September 2, 2007.
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The FDA is equally hamstrung. Today, it inspects less than one
percent of food imports entering the country. There are over 300 ports
(many landlocked) where food can enter.. At the peak of its funding,
there were FDA inspectors stationed at only 90 of them, and the number
of inspectors has dropped since then.\12\ This has led to a phenomenon
known as ``port shopping.'' Indeed, if a shipment of seafood is
rejected by FDA inspectors at one port because it has begun to
decompose, there is nothing at all to prevent the importer from trying
another port where FDA simply may not be present.
---------------------------------------------------------------------------
\12\ Testimony of Caroline Smith DeWaal, House Energy and Commerce
Committee, Subcommittee on Oversight and Investigations, Import
Inspection Failures and What Must Be Done, July 17, 2007.
---------------------------------------------------------------------------
In the absence of adequate FDA and CPSC capacity, Customs and
Border Protection becomes the fallback consumer protection agency at
the borders. In fact, when FDA issued its ``detain and test'' order for
Chinese seafood in June, CPB appeared with FDA to discuss how it would
be implemented. Until recently, however, little was being done to
coordinate these fragmented inspection efforts, or to determine if
there could be efficiencies developed through better coordination and
communication. The Report to the President of the Interagency Working
Group on Import Safety identified ``siloed systems'' and in particular
the inability of CPB and USDA's data bases on imports to connect with
each other, as problems that needed to be addressed.\13\
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\13\ Interagency Working Group on Import Safety, Protecting
American Consumers Every Step of the Way, September 10, 2007.
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It is essential that we prevent chemical and nuclear threats that
might be hidden in shipments coming across our borders. But food can
also be a vehicle for doing serious damage to the health of the U.S.
population. So far, the health threats we have found in food seem to be
the result of neglect, carelessness, or greed. But deliberate
contamination could also occur. The CPB, FDA, CPSC, and the U.S. Dept
of Agriculture must coordinate better, and get the resources they need
to protect the borders.
Overall, Consumers Union recommends that Congress consider three
steps to address these problems:
1. Mandate a major increase in the border inspection staffs at both
CPSC and FDA. One way to raise the funds to cover this would be through
user fees on imports.
2. Require FDA and CPSC to establish federally supervised systems
for independent third party certification of imports, and require that
those imports be certified to meet U.S. safety standards.
3. Give USDA and FDA explicit authority to recall contaminated
food; currently all recalls are voluntary.
The second major cause of the import problems we are currently
seeing lies with our trade policy. I also sit on the State Department
Advisory Committee on International Economic Policy and Trade, and work
closely with sister consumer organizations in other countries who
belong to Consumers International. For many years, U.S. trade policy,
at the direction of Congress and the Executive Branch, has proceeded
with blinders on towards just one goal--that of gaining U.S. companies
access to markets in other countries--with little consideration to the
impact on the domestic economy or marketplace. That approach to trade
policy needs to change. Our current trade policy has had profound
effects on life in the United States. Our toy manufacturing industry,
for example, has disappeared. Congress has begun to think about looking
at the impact of trade agreements on labor standards and the
environment. We must also, however, look at how trade agreements affect
the safety of the products we give to our children, eat for breakfast,
feed our dogs and cats, and sleep on. Unless we look more closely at
the impact our trade policy has on safety issues, our quality and
standard of living will decrease, rather than increase as it can and
should do. Our trade policy has to take a more holistic approach.
Consumers Union would like to make several recommendations as a way
to begin to improve our trade policy.
1. A simple, yet important change would be to broaden the many
advisory committees that provide the marching instructions to the U.S.
Trade Representative, to include representatives of consumer,
environment, and labor organizations and the general public. Currently
those advisory committees include only representatives of the business
community. A bill to do this, H.R. 3204 was recently introduced by
Representative Chris Van Hollen and was referred to this committee.
2. Congress should examine the four pending trade agreement, past
trade agreements, and any new agreements negotiated in the future to
determine whether they adequately protect the right of Federal, State
and local governments to protect the safety of their citizens. One type
of provision that should not be included in such agreements is the
``Chapter 11'' agreement that is part of NAFTA. This provision allows
companies who invest in another country, and whose profits are damaged
by a foreign regulatory action, to be compensated for their loss. This
probably sounded good in the context of possible nationalization of
American investments in telecom infrastructure or oil fields in foreign
countries. However, one must always consider how such provisions will
work when they are turned around and applied at home. A Canadian
company operating funeral parlors in Mississippi sought compensation
under NAFTA when new state regulatory actions forced it to end certain
anti-competitive and predatory business practices. The case was
dismissed, but only because the company had reorganized as a U.S.
corporation, and was thus no longer eligible for a claim as a foreign
investor.\14\ Our negotiators should request from others only those
things we would be happy to have others requested from us.
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\14\ Public Citizen, NAFTA's Threat to Sovereignty and Democracy:
The Record of NAFTA Chapter 11 Investor-State Cases 1994-2005, February
2005.
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3. Our trade policy and our trade negotiators in the State Dept,
USTR, and U.S. Dept of Agriculture, should be directed by Congress to
give attention not just to copyright and counterfeiting problems that
cut into U.S. company profits, but also to the counterfeiting of
safety-related labeling. I have been at many meetings where I have
heard how hard the U.S. is working to address exporter's problems with
counterfeit CDs in foreign countries. We also think counterfeiting of
consumer products is a problem. However I have never heard much talk
about working hard to address the problem of counterfeiting of the
Underwriters Laboratory logo. This is an extremely serious safety
problem, one that can result in serious injury or death to a consumer
who buys a defective electrical product. Yet although there are
numerous State Dept and USTR initiatives on intellectual property, and
enforcement of copyright related to movies and CDs, I am aware of no
such efforts on this important safety-related counterfeiting issue.
4. Congress should ensure that where trade negotiators seek
harmonization of standards, they seek to harmonize up, and not down.
Where our standards are lower than another country's, we should always
see how we can improve, not try to force or encourage others to reduce
their protection. For example, the U.S. has been involved in a
protracted trade dispute with South Korea and Japan about exports of
our beef. Japan has stricter standards than we do about testing for mad
cow disease--every animal over the age of twenty months is required to
be tested at slaughter. We only test about a tenth of a percent of U.S.
cattle that die or are slaughtered. One simple solution to our trade
problem with Japan would have been to allow U.S. companies who export
to Japan to test the cows they slaughter for that market. However, the
USDA has actually forbidden one company, Creekstone, from taking that
step.\15\ Indeed, the government appears to be trying to deepen the
divide between us and Japan by opening our border further to Canadian
cattle and beef, which have had significantly more cases of mad cow
disease than U.S. cattle.\16\ To us this seems like the wrong approach
to solving trade disputes.
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\15\ Reynolds, George, ``Private BSE Testing on Hold Following
Appeal,'' Food Production Daily-USA, May 31, 2007.
\16\ Consumers Union News Release,'' Consumers Union Calls on USDA
to Continue Ban on Beef from Canada,'' March 12, 2007, available at
www.consumersunion.org.
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5. Congress should investigate whether WTO rules may hamper the
ability of Federal regulatory agencies to protect the public, and if
so, address the issue. It is important that all trade agreements, and
our trade policy in general, allows for targeted, risk-based
enforcement actions against products from particular countries when
warranted. WTO trade rules in general provide that one country cannot
impose stricter, or differing safety standards on products of other
countries than it imposes on its domestic production. In the area of
food safety, this may pose a number of dilemmas. As noted previously,
our agencies are seriously understaffed. If agencies see a greater
incidence of violations in products from a particular area--as they
recently did with seafood from China--it is important that they
continue to be able to target such problem areas for increased
inspection and testing. In addition, many U.S. food regulations are
actually in the form of guidance, which is not mandatory, but which is
widely followed by U.S. industry nevertheless. It may be necessary for
such guidance to become regulation, so that other countries are
obligated to conform under WTO rules.
In sum, in recent years, while imports have ballooned, regulatory
capacity has shrunk. Our regulatory capacity must be overhauled to meet
the import challenge. In addition, our trade policy must be more
holistic, and trade agreements must be designed with protection of
product safety in mind. Thanks you for considering these issues.
Chairman LEWIS. Thank you very much.
I am pleased to welcome John Connelly, the president of the
National Fisheries Institute. Welcome.
STATEMENT OF JOHN CONNELLY, PRESIDENT, NATIONAL FISHERIES
INSTITUTE, MCLEAN, VIRGINIA
Mr. CONNELLY. Thank you, Mr. Chairman, Mr. Levin and--
excuse me--Chairman Levin, and Mr. Herger.
NFI represents the seafood community in the U.S., from
water to table. We have large domestic producers in Alaska,
Pacific Northwest and in places like New England. We also
represent importers, processors and the shops that sell us
seafood at the local restaurant and grocery store.
Fish is a unique product. Just today, there was another
major study that was announced encouraging Americans to eat
fish, especially young women, to eat fish at least two to three
times per week. At a time when half of the people in this room,
half of the people on the dais, half the people behind the dais
and half the people listening behind me, will die of heart
disease, doctors and dietitians are encouraging Americans to
eat seafood because of it's positive health benefits,
particularly the omega 3s.
Americans have heard that message and we are eating seafood
at record levels. But where does our seafood come from?
U.S. seafood--excuse me--U.S. fisheries are very well
managed. About four in five are deemed sustainable by the
fisheries scientists in the Department of Commerce. But with
that sustainability comes a cap on how much fish U.S. fishermen
can actually catch. Simply put, demand, because of the health
benefits of seafood, has outstripped supply, because of the
U.S. insistence on a sustainable fishery system.
So, now we import about 80 percent of seafood into this
country. That is actually a good thing, because it allows
families in Michigan or in Georgia or in Minnesota to enjoy the
same health benefits as somewhere on the upper east side of New
York City.
The vast majority of seafood imports remain safe. There is
not a documented case of seafood imports causing a health
situation. That said, the seafood import system is not perfect,
as evidenced by recent news and press accounts from China.
NFI supports FDA's zero tolerance for the use of
unauthorized antibiotics. We also supported FDA's imposition of
an import alert on China in June of this year.
While China has not caused an immediate health scare
regarding seafood, the import alert was an important shot
across the bow of China to make sure they stop any practice
that is illegal in the U.S.
NFI supports several concepts to strengthen the food safety
system here, to create a targeted, more risk-based approach to
imports particularly. First, on the import side, we believe it
should be more difficult to become a food importer into the
U.S. That's right, we are looking for more regulatory oversight
of FDA on our business. FDA should create a certification
system for importers that goes beyond the current passive
model.
On the export side, NFI believes exporting countries should
be required to certify any company exporting food to the U.S.
as being in compliance and in good standing with their food
safety laws.
As has been mentioned before, NFI strongly supports a
significant increase in FDA resources on both the personnel
side and in the infrastructure. By doing so, we believe that we
can shine a spotlight on those countries or companies that have
exhibited a problem, while at the same time rewarding the good
companies and countries that do things well.
As an example of how industry and government can work
together, in 2005, Vietnam had--the FDA had found out that
Vietnam had a number of companies using fluoroquinolone, an
unauthorized antibiotic. NFI travelled to Vietnam to encourage
both the companies and government to take action. Subsequently,
Vietnam banned that product, conducted a significant
educational system out in their farm communities. They began
100 percent testing for fluoroquinolones and had swift and sure
punishment for anyone misusing that product.
The results have been impressive. In 2006 and 2007, to
date, there have been zero shrimp imports from Vietnam with
testing positive for antibiotics. There have been zero basa or
tra, a kind of Chinese--excuse me--Vietnamese catfish, testing
positive for antibiotics. That is a good example of industry
and government working together.
We do think there is significant opportunity for the U.S.
to take a holistic approach, where FDA can work much more
closely with CBP and other government agencies in order to
extend the resources that FDA has.
We look for ward to the discussion with the Committee and
Congress more broadly in this debate.
[The prepared statement of Mr. Connelly follows:]
Prepared Statement of John Connelly, President,
National Fisheries Institute, McLean, Virginia
Good Morning, Chairman Levin, Chairman Lewis and Members of the
Subcommittees. I appreciate the opportunity to testify today on the
issue of import safety and the work the American seafood industry is
doing to ensure that consumers who depend on fish and seafood as part
of a healthy diet and lifestyle enjoy the safest products possible. I
plan to focus my testimony today on three areas: 1) current food safety
practices and regulations designed to protect consumers; 2) specific
examples of the seafood community working collaboratively with our
trading partners to ensure safe seafood imports; and 3) several key
principles and recommendations that Congress should consider when
developing a risk-based system for food protection. On this final
point, I understand that several legislative and industry plans for
food safety have been proposed in recent months; however I feel that
our industry principles take a uniquely progressive approach to working
with government on these important matters.
For more than 60 years, the National Fisheries Institute (NFI) has
been the Nation's leading advocacy organization for the seafood
industry. NFI's members provide American families with the variety of
sustainable seafood essential to a healthy diet. Our member companies
represent every element of the industry--from oyster farmers off
Connecticut's shores to fish processors in Minnesota to retail and
restaurant chains from Maine to California. From responsible
aquaculture, to a marketplace supporting free trade, to ensuring
consumers have the facts on the health benefits of fish and shellfish,
NFI and its members support and promote sound public policy based on
scientific research.
It is imperative to understand the importance of seafood to a
healthy diet. As more Americans die from heart and related diseases,
the consistent message from public health officials is that we should
all be eating more seafood--at least twice per week. Fish is, without
question, the protein choice that provides essential omega-3s and other
nutrients that doctors and dieticians recommend we take advantage of.
Americans have heard that health message and seafood consumption is at
record levels.
Domestic fisheries provide excellent products, and NFI is proud to
represent the vast majority of the value and volume of domestic
producers. Because the U.S. does a very good job managing our Nation's
fishery resources, we are limited in our supply. Wild capture fisheries
are unlike land based agriculture, where farmers can just plant
additional acres of crops. Fishermen are limited in the number of fish
they can catch. And we simply cannot produce enough seafood for the
demand created for such a healthy product.
Imports are an essential and helpful way to ensure Americans enjoy
the benefits of seafood. Approximately 1,000 U.S. firms are in the
business of importing fish and shellfish and top imports included
shrimp, salmon, tilapia, pollock and tuna. U.S. seafood companies, many
of which are small, family-owned enterprises, import fish from more
than 130 nations, including Canada, Iceland, Thailand, China, Ecuador,
Chile and Mexico.
Consumer confidence is essential to the retailers and restaurants
that provide meals to American families. Consumers must have faith that
the government and private sector have worked together to ensure the
meals they eat are safe. As a result, and because much of our supply is
from overseas the seafood community places exceptional emphasis on the
safety of the imported seafood supply.
Seafood remains one of the safest foods produced--whether domestic
or imported. In fact, there have been no illnesses reported as a result
of imported seafood that has been properly handled, stored and
prepared. However, as evidenced by recent positive test results for
unauthorized antibiotics and substances in a few select seafood
imports, it is apparent that our Nation's system is not perfect. There
is more that we--the seafood community and government--can and should
do to protect consumers.
The cornerstone of a strong food safety program is a strong Food
and Drug Administration. NFI has, since the beginning of this Congress,
supported enhanced funding for FDA's Center for Food Safety and Applied
Nutrition (CFSAN) and development of a risk-based system of food
protection. A primary goal for the FDA should be to reduce points at
which food safety challenges can occur, at both the exporter and
importer level. FDA should develop a preventative approach that
prevents problems at their source, rather than at U.S. borders.
Importantly, FDA should seek to work with other agencies, like the
Custom and Border Protection, to identify areas of cooperation and
coordination, in order to maximize the effectiveness of all Federal
Government agencies.
NFI supports a risk-based approach to import inspections. We should
``reward the good'' and shine a spotlight on those not adhering to our
requirements. We should focus the bulk of FDA's resources on imports
from foreign companies or countries that do not have a strong record of
safe and secure shipments to the U.S. Further, NFI supports the
creation of a program to certify private labs that could work under FDA
authority where importers of record could pay for expedited
inspections. This would help reduce the level of backup at our Nation's
ports and also free up FDA's public labs for testing of the riskier
shipments.
NFI has a long history of working collaboratively with Federal
officials to ensure the wholesomeness of seafood products, including
being early supporters and adopters of the Hazard Analysis and Critical
Control Point (HACCP) concept. HACCP is the foundation of our
comprehensive program for seafood safety and is a cost-effective,
prevention-focused ``video'' model that identifies and targets those
critical points in the import life cycle where the risk of unsafe
products is greatest and verifies the steps are in place to avoid
problems. It is an essential strategy to prevent unsafe products from
entering the United States.''
Current regulatory requirements have been in place for almost 10
years for controlling the safety of imported seafood products. To
summarize, the current regulatory requirements for importers of seafood
products are as follows:
Every importer of fish and fishery products is required to have and
implement written verification procedures for ensuring that the
products that they offer for import into the United States were
processed in accordance with the Seafood HACCP and sanitation
requirements.
Importers are required to have product specifications that are
designed to ensure that the product is not adulterated as defined by
the Federal Food, Drug, and Cosmetic Act.
FDA requires seafood importers to take affirmative steps and
maintain records to ensure that products being offered for entry are
actually produced under controls that meet U.S. Seafood HACCP
regulations.
The purpose of the affirmative steps is to assure that overseas
processors have and implement HACCP when necessary. Importers have
several options suggested by FDA for the affirmative steps:
Obtain foreign processor HACCP and sanitation monitoring
records for each lot.
Obtain either a continuing or lot-by-lot certificate from
the foreign government inspection authority or competent third party
certifying that the product was processed in accordance with the HACCP
regulations.
Regularly inspect the supplier's processing facilities to
ensure that the product is processed in accordance with the HACCP
regulation.
Maintain a copy of the processor's HACCP plan along with
a written guarantee that the product is processed in accordance with
the regulations.
Periodically test the imported seafood products and
maintain a written guarantee that product is processed in accordance
with the regulation.
Importer affirmative action steps are a cost-effective method for
providing the ``video'' of preventive controls, a key component of the
strategic framework for continual improvement in import safety.
Requiring importers to be the ``eyes'' in the field, so to speak, to
ensure that the exporting companies understand and follow U.S.
regulations, allows FDA to perform ``snap shot'' risk-based inspections
at the ports. This preventative approach identifies and controls
problems at the source, rather than at U.S. borders.
As an example of the effectiveness of addressing safety concerns at
the source, I would like to highlight how our industry dealt directly
with a notable food safety situation in Vietnam. In 2005, the FDA
placed two shippers of Vietnamese basa on detention without physical
examination status due to residues of fluoroquinolone (FQ) antibiotics
found in shipments exported to the U.S. Following the alert, NFI
immediately communicated our concern with the U.S. FDA, the Vietnamese
government, and most importantly, the Vietnamese exporting companies.
We explained the need to: 1) prohibit unauthorized antibiotics for use
in fish farming as dictated by market countries; 2) develop an
education campaign for farmers and processors about the antibiotics
ban; and 3) develop an in-country testing system; and 4) implement
swift and sure punishment for violators. NFI met with the FDA to
explain our industry-to-industry work and encouraged them to adopt
parallel government discussions. NFI also sent a delegation to Vietnam
to speak directly to a major aquaculture conference to express the need
to adhere to U.S. regulations for commodities exported to this country.
In October of 2005, Vietnam announced a ban on use of antibiotics and
began a comprehensive testing program for all seafood exported to the
U.S. Results have shown a near complete success in ensuring Vietnamese
seafood is not tainted with unauthorized antibiotics.
NFI's work in Vietnam illustrates how industry and FDA can work
together to send the message that complying with U.S. regulations for
products shipped into this country is imperative if exporters intend to
maintain a positive relationship with their American customers.
NFI's specific recommendations for an enhanced food import program
include:
Require FDA to certify food importers: FDA should
register food importers, after ensuring the company has the training
and management expertise to understand and adhere to food safety laws.
This proposal would align the U.S. with a Canadian approach to seafood
imports.
Require foreign countries to certify exporters: Foreign
governments' food safety agencies should certify that food processors
intending to export to the U.S. adhere to applicable safety regulations
established by the exporter country's competent food safety agency.
This program would be similar to the European Union approach to food
imports.
Strengthen FDA with more resources: Increase FDA CSFAN
funding by at least $200 million, to be used for more personnel and
information technology.
Develop common standards among countries: Through Codex
Alimentarius, (the inter governmental group responsible for
establishing food safety and labeling protocols) the U.S. should seek
harmonized food safety and labeling laws among food trading partners.
Require FDA to certify labs: FDA should certify labs
capable of sampling and testing food in accordance with FDA guidelines
and Good Laboratory Practices.
Enable third party testing of food imports: Using FDA-
certified labs and operating under an FDA-sampling plan, enables
increased testing of imports to be conducted. Importantly, these third
party labs are not replacing existing essential government jobs, but
adding an additional layer of testing capability for FDA. FDA should
use private sector labs to conduct testing, as recommended by a GAO
report.
Develop rapid test kits: Seafood companies are examining
means to dramatically increase testing of food at its source, either
domestically or overseas. FDA should support these efforts.
Alternatively, NFI does not support:
Fee for service: Industry fees for government services
are perceived as a conflict of interest. The U.S. cannot ``inspect its
way'' to food safety. Rather, inspections should be targeted at
countries or companies that have exhibited problems. Companies that
adhere to laws and rules should be rewarded with streamlined importing
requirements.
Restricting food imports to certain ports: Ninety percent
of seafood shipments enter through 14 ports and only 5 of those ports
are associated with an FDA lab designed to test food. Dock workers in
nine port cities could no longer be employed to off load seafood in
nine cities if this were proposal were enacted.
Country of origin labeling for imported seafood. The
seafood industry already labels seafood under country of origin
requirements for Customs and Border Protection and the U.S. Department
of Agriculture. A third agency labeling requirement (under FDA) will
simply confuse the consumer and will do nothing to improve food safety.
None of the current food safety proposals address the notion of
``certifying'' importers. Because it is unique, this concept deserves
special mention. Seafood imports follow the 80:20 rule--80 percent of
the seafood imported into the U.S. is imported by about 20 percent of
the importers. Therefore about 80 percent of the seafood importers are
what we would consider as ``infrequent'' importers. This is why NFI and
its members support the registration and certification of importers. We
feel that it is essential that importers recognize, understand, and
adhere to the applicable laws and regulations associated with ensuring
the safety of seafood products. Importer registration and certification
would provide FDA with additional regulatory tools to establish a risk-
based import inspection system by enabling the agency perform targeted
inspections and surveillance sampling and issue import alerts when
warranted. Even with more resources for FDA, a concept which we
strongly support, the agency will need additional regulatory tools to
prioritize import inspections.
Americans enjoy seafood because it is good for them and they can
enjoy a variety of meals, both at home and dining out. Because
consumers must trust those that sell them fish, the seafood industry
has long been a leader in food safety. We rely on a healthy and secure
global supply chain to meet the growing demand for fishery products
here at home. As the debate regarding the safety of imports moves
forward, NFI looks forward to working with the Committee to address
ways Congress can help make the government side of the food safety
system as solid.
Chairman LEWIS. Thank you very much, Mr. Connelly for your
testimony.
I'm pleased to welcome our next witness, John Williams from
the Southern Shrimp Alliance, the executive director. Welcome.
STATEMENT OF JOHN A. WILLIAMS, EXECUTIVE DIRECTOR, SOUTHERN
SHRIMP ALLIANCE, TARPON SPRINGS, FLORIDA
Mr. WILLIAMS. Thank you, Chairman Levin, Chairman Lewis,
good afternoon. My name is John Williams. I am the executive
director of the Southern Shrimp Alliance, and I appreciate the
opportunity to testify on the need to significantly improve
this country's safety program for imported seafood.
The American public is gravely concerned that the seafood
imports they consume may not be safe and our Federal Government
is not taking necessary steps to safeguard the health and
safety of its people. Consumers have a right to be concerned.
The FDA's imported food safety regime is broken, it is lax,
ineffective and dangerous. Weak FDA enforcement coupled with
stringent import safety regimes and other major seafood
importing markets encourages diversions of unsafe shrimp
imports to the United States. As a result, the United States
has become a magnet for contaminated shrimp imports.
For example, the E.U. has refused to allow Cambodian
seafood exports into the E.U. market because of severe
deficiencies in Cambodia's food safety system. At the same
time, 99 percent of Cambodia's shrimp exports came to the
United States.
Earlier this year, the E.U. banned seafood exports from
Pakistan. As exports of seafood to the E.U. dwindled to
nothing, Pakistan's exports of shrimp to the United States
surged to record highs.
A look at the import seafood safety system used by the
E.U., Japan, Canada and the USDA demonstrates the deficiencies
of the FDA's model which relies solely on point of entry
inspections of only 1 percent of imported seafood products.
The E.U. inspects and certifies exporting countries and
individual exporters prior to a product's entry into the E.U.
The E.U. inspects 20 percent of all seafood imports at its
borders and conducts on-site inspections of foreign facilities.
Japan has a strict risk-based system with a 25 percent
inspection rate on shrimp imports and also imposes
certification requirements.
Canada imposes a minimum standard inspection rate of 15
percent for all imported seafood products and strict licensing
requirements for importers.
For USDA regulated food imports, equivalence is a
prerequisite for imports. The USDA conducts foreign on-site
inspections and inspects every import at the port of entry.
These examples and trade statistics demonstrate a direct cause
and effect relationship. Market closures and restrictions on
imports by major importing countries directly result in the
diversion of contaminated products to the United States.
Further, the FDA's import enforcement failures largely render
Customs unable to assist in assuring the safety to seafood
imports.
As the U.S. shrimp industry has witnessed firsthand,
despite limited resources, Customs aggressively addresses the
unlawful activities of U.S. importers. Customs implemented an
enhanced continuous bonding requirement to ensure the duties on
shrimp imports were collected. Customs uncovered importers
schemes to circumvent the antidumping order by transshipping
Chinese shrimp through Indonesia and falsely labeling Chinese
shrimp as dusted shrimp. Customs can and should play an
important role in ensuring the safety of imported food. The
implementation of a true equivalence based food safety system
like the USDA and the E.U. would require the FDA to certify
that an exporting country's food safety laws are at least
equivalent to our country's. Customs would be able to evaluate
whether a particular product was shipped from an approved
exporter located in an approved country. In addition, customs
should be given the authority to quarantine imports of high-
risk products and products from high-risk countries or high-
risk producers. Once quarantined, import shipments that are
found to violate U.S. food safety standards should either be
destroyed by Customs or, in limited circumstances, redispatched
after being marked by Customs with the words, United States
refused entry.
Importer interests consistently thwart improvement of U.S.
food safety laws by arguing that such improvements would be
protectionist and might violate the U.S. international trade
obligations. Such assertions are simply incorrect. The FDA's
oversight of imported food lags substantially behind that
employed in other countries and the USDA. Any improvement in
the FDA's regulatory authority would, at most, simply bring the
U.S. in line with international best practices.
Moreover, as the FDA has recognized, article 20 of the GATT
provides that a nation may adopt or enforce any measure
necessary to protect human, animal or plant health. Thus, the
improvement of FDA's imported seafood safety program would be
consistent with our international trade obligations.
Seafood importers have fought tooth and nail to prevent
improvement of the regulation of safety of seafood imports.
These importers are more interested in minimizing their cost
than in protecting consumers. Voluntary programs undertaken by
importers have been ineffective and that is why you have called
us here today.
Most like the National Fisheries Institute proposal to mark
contaminated products with invisible ink, importers voluntary
programs might as well have been written in invisible ink.
Multiple reports from a variety of government agencies have
repeatedly made clear that the FDA's oversight of seafood
imports is woefully inadequate. We urge Congress to take this
opportunity to fix this problem and not be distracted by the
self-interested empty promises that have been repeatedly made
by seafood importers.
In closing, there comes a time when common sense must
prevail and Americans' consumer health cannot be negotiated
through trade agreements or the bottom line of importers. Thank
you.
[The prepared statement of Mr. Williams follows:]
Prepared Statement of John A. Williams, Executive Director,
Southern Shrimp Alliance, Tarpon Springs, Florida
Chairmen Levin and Lewis and Members of the Committee on Ways and
Means, Trade and Oversight Subcommittees, my name is John Williams and
I am the Executive Director of the Southern Shrimp Alliance (``SSA''. I
appreciate the opportunity to testify on the need to significantly
improve this country's safety program for imported seafood.
The SSA, founded in 2002, is a non-profit alliance of the hard-
working men and women of the U.S. shrimp industry. We are the national
voice for shrimp fishermen and processors in eight states: Alabama,
Florida, Georgia, Louisiana, Mississippi, North Carolina, South
Carolina, and Texas. In addition to defending and advancing the
interests of the domestic industry, the SSA is committed to preserving
the safety and integrity of the Nation's shrimp supply.
The American public is gravely concerned that the imported seafood
products they consume may not be safe and that the Federal Government
is not taking necessary steps to safeguard the health and safety of its
people. An examination of the food safety regimes of major food
importing countries including the European Union (``EU''), Japan, and
Canada make clear that stringent import systems can be effective in
protecting food supplies while facilitating trade in safe products.\1\
In stark contrast, the U.S. Food and Drug Administration (``FDA'')
relies solely on point-of-entry inspection of one percent of imported
seafood products as the first and last line of defense.\2\ As a result
of the FDA's lax enforcement, there is a direct cause and effect
between market closures or restrictions on imports into other major
importing countries and the diversion of contaminated products to the
United States.
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\1\ A detailed explanation of the substantial differences between
the FDA's regulatory program on seafood imports and the systems
employed by other major seafood importing countries and the USDA are
provided in the SSA's written submission to the President's Interagency
Working Group on Import Safety. The SSA's submission can be obtained
from our web-site, www.shrimpalliance.com.
\2\ FDA's Imported Seafood Safety Program Shows Some Progress, But
Further Improvements are Needed, U.S. General Accounting Office, Report
to Congressional Requesters, GAO-04-246, p. 3 (2004) (``2004 GAO FDA
Report''); Diminished Capacity: Can the FDA Assure the Safety and
Security of the Nation's Food Supply--Part 2, Hearing before the
Subcomm. on Oversight and Investigations of the H. Comm. on Energy and
Commerce, 110th Cong., p. 2 (July 17, 2007) (Statement of David Nelson,
Senior Investigator) (``David Nelson Testimony'').
---------------------------------------------------------------------------
In short, the imported food safety program administered by the FDA
is lax, ineffective and dangerous. Particularly with seafood imports,
the FDA has largely abdicated its responsibility to ensure the safety
of such imports.
A comparison of the FDA's regulatory oversight over imported
seafood with the oversight of imported seafood in the EU, Japan, and
Canada and even the U.S. Department of Agriculture's (``USDA'')
oversight of imported meat, poultry, and egg products makes clear the
deficiencies in the FDA's program. Because the FDA inspects only
approximately 1 percent of all seafood imports,\3\ imports contaminated
with harmful drug residues, pesticides, salmonella, and common filth
enter the United States virtually undetected. The FDA does not require
that seafood be imported from countries that administer food safety
laws that are at least equivalent to our own and instead relies heavily
on seafood importers to guarantee the safety of the products that they
bring into this market.
---------------------------------------------------------------------------
\3\ Id.
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There is a stark contrast between the FDA's model and the
regulatory models employed in the EU, Japan, and Canada: The EU
guarantees equivalence by conducting on-site inspections and certifying
exporting countries and individual exporters prior to importation of a
product. Stringent follow-up inspections are conducted both at the EU's
border (currently 20 percent of seafood products are inspected) and
regularly at the foreign exporters' facilities.\4\ Japan has a strict
risk-based system that is reinforced by high inspection rates
(currently 25 percent for shrimp imports), as well as certification
requirements and significant penalties for noncompliance.\5\ Canada
imposes a minimum standard inspection rate of 15 percent for all
imported seafood products and strict licensing requirements for
importers.\6\
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\4\ See EU Import Conditions for Seafood and Other Fishery
Products, Directorate-General of Health and Consumer Protection,
European Commission (``EU Import Conditions'').
\5\ See Handbook for Agricultural and Fishery Products Import
Regulations, Japan External Trade Organization (Dec. 2005) (``JETRO
Handbook for Import of Fishery Products'').
\6\ See Guide to Canadian Regulatory Requirements and Examination
Procedures for Imported Fish, Canadian Food Inspection Agency; L.
Ababouch, G. Gandini & J. Ryder, Causes of Detentions and Rejections in
International Fish Trade, Food and Agriculture Organization of the
United Nations, FAO Fisheries Technical Paper 473, pp. 21-22 (2005)
(``2005 FAO Fisheries Paper'').
In addition, Canada conducts ``specialized testing'' at a rate of
``5 to 15 percent, depending on the product history and nature of the
product.'' 2005 FAO Fisheries Paper at p. 22.
---------------------------------------------------------------------------
For USDA-regulated food imports, equivalence of food safety laws is
a prerequisite for import into the United States. The USDA verifies the
equivalence of laws through foreign on-site inspections and the USDA
inspects every import at the port of entry.\7\
---------------------------------------------------------------------------
\7\ See Process for Evaluating the Equivalence of Foreign Meat and
Poultry Food Regulatory Systems, Food Safety Inspection Service, United
States Department of Agriculture, p. 2 (Oct. 2003) (``USDA Equivalence
Guide'').
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On Monday of this week, the SSA submitted comments and presented
testimony at a public hearing before the President's Interagency
Working Group on Import Safety (``Interagency Working Group'') that
were highly critical of the FDA's regulation of seafood imports. I note
with particular interest that the opening comments to that public
meeting made by the Acting Secretary of Agriculture, Chuck Conner,
underscored the immense gulf between the USDA's approach to ensuring
the safety of imported food products and that of the FDA's. Secretary
Conner noted that the USDA's approach to imported food safety relied on
three keystones: prevention, early intervention, and rapid response to
problems.\8\ He explained that the USDA begins its implementation of
these keystone principles ``with a thorough analysis of each country's
food laws and inspection systems to determine initial equivalents with
our own safety procedures.'' \9\ Secretary Conner added that the USDA
continues with ``on-site audits of each country's food safety system to
ensure equivalence is maintained as well.'' \10\ Secretary Conner
further observed that a USDA Food Safety and Inspection Service
(``FSIS'') inspector conducts a port-of-entry investigation on imports
of all meat, poultry, and egg products coming into the United States
and that ``[a]bout 10 percent of our imports of meat, poultry, and egg
products as well are subjected to more intense inspection that includes
microbiological analysis for pathogens.'' \11\
---------------------------------------------------------------------------
\8\ Hearing before the Interagency Working Group on Import Safety
(Oct. 1, 2007) (Statement of Chuck Connor, Acting Secretary of
Agriculture).
\9\ Id.
\10\ Id.
\11\ Id.
---------------------------------------------------------------------------
In fact, in its own publications, the USDA contrasts the rigors of
its imported food safety program with the comparative laxity of the
FDA's. In one passage of a recent USDA publication, the agency stresses
that the:
FDA relies solely on point-of-entry inspection. FSIS, on the other
hand, works collaboratively with the importing establishment's
government and uses a three-part process to verify that other
countries' regulatory systems for meat, poultry and egg products are
equivalent to that of the U.S. and that products entering the U.S. are
safe and wholesome.\12\
---------------------------------------------------------------------------
\12\ Importing Meat, Poultry & Egg Products into the United States,
USDA Food Safety and Inspection Service, (Dec. 2003) (``USDA Import
Guidelines'') (emphasis added).
---------------------------------------------------------------------------
The September 10, 2007 report issued by the Interagency Working
Group further underscored the fundamental disparities of our food
safety laws. Specifically, the report noted that:
[I]n 2006, [Customs] intercepted 45 containers with chicken,
chicken parts, pork and meat products being smuggled into the U.S. as
frozen seafood. These meat products were prohibited entry into the U.S.
because they were from a country that was not approved by USDA to
export them to the U.S.\13\
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\13\ Protecting American Consumers Every Step of Way: A strategic
framework for continued improvement in import safety, A Report to the
President, Interagency Working Group on Import Safety at p. 9 (Sept.
10, 2007) (``Import Safety Report'') (emphasis added).
---------------------------------------------------------------------------
This example is important for three reasons. First, seafood
products routinely enter the United States from countries that the USDA
does not permit to export meat, poultry, or egg products because the
agency has determined that those countries do not maintain food safety
laws equivalent to our own.\14\ Second, even where seafood imports
enter the United States from countries that do not administer U.S.-
equivalent food safety laws, the chances that the FDA will inspect a
shipment of imported seafood are so low that importers believe that
they can bring in containers filled with meat products, label it as
seafood, and enter the product into the United States with no one the
wiser. Third, the FDA did not discover that these 45 containers were
mislabeled as seafood. The Federal Agency that uncovered an importer's
blatant attempt to circumvent our food safety laws was U.S. Customs and
Border Protection (``Customs'').
---------------------------------------------------------------------------
\14\ Large seafood exporting countries to the United States, such
as Thailand, Ecuador, and Vietnam, are not certified to export USDA-
regulated products. See Eligible Foreign Establishments, USDA Food
Safety and Inspection Service.
---------------------------------------------------------------------------
One consequence of the FDA's failure to implement an equivalence-
based safety program for imported seafood is that it makes it extremely
difficult for Customs to assist in ensuring the safety of seafood
imports. In a system based on verified equivalence, only food imports
from approved producers in approved countries can enter the United
States. Evaluating whether both the country and producer are accurately
disclosed in import entry documentation is exactly the type of activity
that Customs officials are trained to undertake.
The U.S. shrimp industry has witnessed firsthand the aggressive
nature with which Customs works to address unlawful activities of U.S.
importers and the agency does so with extremely limited resources.
Three examples of Customs' actions with respect to the antidumping
orders on shrimp demonstrate the agency's initiative.
First, after the imposition of the antidumping orders on shrimp,
Customs' National Targeting and Analysis Group noted substantial shifts
in import patterns that suggested transshipment of shrimp to circumvent
high tariffs imposed on shrimp from China and Customs worked quickly to
counteract the circumvention. Officials with Immigration and Customs
Enforcement in Singapore visited plants in Indonesia identified by the
National Targeting and Analysis Group and confirmed that three
Indonesian exporters were labeling Chinese shrimp as Indonesian shrimp
to circumvent the antidumping orders. Customs found that 54 different
importers were responsible for bringing in over $58 million in
mislabeled shrimp product to avoid payment of 65 million in antidumping
duties.\15\ Last Friday, the agency announced that it has already
successfully recovered over $2.2 million of the $65 million in
antidumping duties owed on these entries.\16\
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\15\ Declaration of Bruce W. Ingalls, Chief of the Debt Management
Branch in the Revenue Division of the Office of Finance, National
Fisheries Institute, Inc. v. United States, Court No. 05-00683 (Mar. 9,
2006). According to CBP officials, importer members of the National
Fisheries Institute were responsible for ``approximately 50 percent''
of the volume of this transshipped shrimp. Id. at p. 4.
\16\ ``U.S. Customs and Border Protection Collects More Than $2.2
Million in Underpaid Antidumping Duty on Chinese Shrimp'' Press
Release. U.S. Customs and Border Protection (Sep. 28, 2007).
---------------------------------------------------------------------------
Second, the domestic industry quickly became aware that many U.S.
importers were abusing an ill-conceived exclusion to the antidumping
orders granted by the U.S. Department of Commerce (``Commerce''). In
the first of many baffling decisions that the agency has taken to
weaken the trade relief that the U.S. shrimp industry is entitled to
under our trade laws, Commerce carved so-called ``dusted'' shrimp out
of the scope of the orders.\17\ Shortly after the exclusion was
granted, massive volumes of purportedly ``dusted'' shrimp from China
flooded the U.S. market. The SSA challenged Commerce's decision in
Federal court and that appeal is ongoing. At the same time, we
approached Customs with evidence that Chinese shrimp entering our
market duty-free as ``dusted'' shrimp was not, in fact, ``dusted''
shrimp. Customs listened to the domestic industry's concerns, developed
an enforcement plan, and then went about stopping importers from
abusing the system. Public information indicates that Chinese
``dusted'' shrimp imports significantly declined once Customs began
inspecting these shipments.\18\
---------------------------------------------------------------------------
\17\ See, e.g., Certain Frozen and Canned Warmwater Shrimp from
India, 70 Fed. Reg. 5147, 5148 (Feb. 1, 2005) (Amended Final
Determination of Sales at Less Than Fair Value and Antidumping Duty
Order).
\18\ See Urner Barry's Foreign Trade Data (Seafood Import Data
Online) available at http://ftd.urnerbarry.com/.
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Third, after problems collecting duties on previous antidumping
orders on food imports, Customs learned from the experience and
implemented an enhanced continuous bonding requirement to ensure that
the full amount of antidumping duties owed on shrimp imports were
collected. After complaints from importers, Customs adjusted the
enhanced continuous bond to allow for an individualized review of an
importer's condition and the agency ably balanced concerns about
preserving the integrity of the antidumping orders with the impact on
importers.
The SSA understands that Customs is the primary agency responsible
for U.S. border enforcement and that the agency's first priority is to
detect and prevent terrorists and terrorist weapons from entering our
country. Nevertheless, despite this overwhelming priority and limited
resources, Customs officials at the ports, in headquarters, and in
specialized field offices have expended significant effort to ensure
that the U.S. shrimp industry receives the full benefit of the trade
relief it fought hard to achieve. And as importers have developed new
schemes to circumvent the antidumping duties, like transshipping
Chinese shrimp through other countries besides Indonesia, we are
confident that the agency will listen to our concerns.
For this reason, the SSA believes that Customs can and should play
a critical role in ensuring the safety of imported food over which the
FDA has jurisdiction. As an initial matter, Customs' import database,
the Automated Commercial Environment, maintains real-time data of
import shipments, which has been used by the USDA to (1) determine
whether shipments arrive from ineligible sources, (2) monitor ports of
entry and importers of rejected shipments, and (3) track rejected or
suspect shipments from the time of entry until Customs determines
whether to detain or redeliver the shipment. The FDA, however, does not
use this database in the same manner as the USDA. Moreover, the FDA's
lax enforcement efforts have hindered Customs' ability to properly
safeguard the Nation from contaminated food imports. For example, in
reviewing the FDA's administration of its food safety program, the U.S.
Government Accountability Office (``GAO'') found that it takes an
average of 348 days for the FDA to notify port-of-entry Customs
officials of a rejected import shipment.\19\
---------------------------------------------------------------------------
\19\ 2004 GAO FDA Report at p. 5.
---------------------------------------------------------------------------
Further, an equivalence-based food safety program would allow
Customs to evaluate whether a particular product was, in fact, shipped
from an approved exporter. In addition, Customs should be given the
authority to quarantine imports of high-risk products, or products from
high-risk countries or high-risk producers. Once quarantined, import
shipments that are found to violate U.S. food safety standards should
be destroyed by Customs unless the importer can meet the following
requirements within 45 days of notification of destruction: (1) if the
adulterated shipment is bound for a third country, the third-country
food safety agency must first notify the FDA of its acceptance before
the rejected shipment is released; and (2) rejected shipments should be
conspicuously marked by Customs as ``United States Refused Entry.''
In any event, the FDA's failure to employ the significant resources
of Customs--resources that include an office that deals specifically
with agricultural products as one of Customs' priority trade issues--is
indicative of the agency's seeming unwillingness to take advantage of
available resources that would allow U.S. agencies to focus resources
where the risks are greatest. For example, on a weekly basis the EU
publishes lists of imported food products that have been found to be
violative of EU food safety standards. Japan and Canada go a step
further and publish lists of food products refused entry into the
country, the reasons for the refusal, and the name of the exporter.\20\
These resources help identify where problems may be concentrated. A
review of the EU's lists indicates that there have been continued
disconcerting findings of banned antibiotics in shrimp and prawn
exports from India to the EU. A review of Japan and Canada's refusal
lists provides information on the specific exporters of shrimp from
Vietnam that have had continued problems with the nitrofurans and
chloramphenicol in their shrimp. In addition, both the EU and the USDA
publish the results and findings of their on-site verifications of the
food safety systems employed in foreign countries.
---------------------------------------------------------------------------
\20\ The EU's RASFF system refusals are also available online but
do not disclose the name of the exporter responsible for the refused
product.
---------------------------------------------------------------------------
Taken together, these resources provide a useful warning system for
existing food safety problems and an early warning system for food
safety problems that are just beginning to appear over the horizon.
There is little indication, however, that the FDA pays much attention
to any of this material. Seafood exports from Vietnam, for instance,
present a significant food safety risk. With the exception of the
United States, every major export market for Vietnamese seafood
products has acted to address food safety problems with Vietnamese
seafood exports.
Canada: From 2003 to 2005, Canada imposed a country-wide alert and
implemented a 100 percent inspection policy on seafood exports from
Vietnam after Vietnamese seafood products repeatedly tested positive
for chloramphenicol.\21\ In July 2006, the governments of Vietnam and
Canada reached a bilateral agreement whereby the government of Vietnam
committed to inspecting and certifying that seafood exports to Canada
were free of antibiotics.\22\ Vietnamese exports not accompanied by a
certification are subject to 100 percent testing by Canadian officials;
and, to insure compliance, Canadian officials continue to test even
some of those exports that are accompanied by certificates.\23\
---------------------------------------------------------------------------
\21\ ``Removal of the Country Import Alert for Chloramphenicol in
Aquacultured Fish Products from Vietnam,'' Press Release, Canadian Food
Inspection Agency (Sept. 30, 2005).
\22\ Arrangement Concerning the Inspection and Certification of
Aquaculture Fish and Fish Products Exported from Vietnam to Canada for
Drug Residues, Canadian Food Inspection Agency and the Vietnamese
National Fisheries Quality Assurance and Veterinary Directorate of the
Vietnam Ministry of Fisheries (Jul. 17, 2006).
\23\ Id.
---------------------------------------------------------------------------
Japan: Beginning in December 2006, Japan began testing 100 percent
of all Vietnamese shrimp exports because of repeated positive tests for
chloramphenicol.\24\ Vietnam agreed to certify 100 percent of their
shrimp exports to Japan.\25\ However, even with the certification
system established, Japan continued to find banned antibiotics in
Vietnamese shrimp imports and has threatened a complete ban of
Vietnamese shrimp products unless the problem is resolved.\26\
---------------------------------------------------------------------------
\24\ ``NAFIQAVED declares three reasons for unsafe seafood,''
Vietnam Economy (Dec. 15, 2006).
\25\ Id.
\26\ ``VASEP asks Minister to declare emergency as Japan threatens
to halt Vietnamese shrimp exports,'' Seafood News (July 9, 2007).
---------------------------------------------------------------------------
Russia: Press reports indicate that Russia banned the import of
Vietnamese seafood after conducting an on-site inspection in March
2007, citing problems with food safety standards.\27\ Russia requires
exporters to meet Russian food safety standards and provide quality
assurance from the exporting country's government.\28\ Russian
officials conducted follow-up inspections of twenty seafood processing
facilities in July 2007 and mid-September 2007 and, recently, announced
that thirteen of these facilities--and only these thirteen--would be
approved to export seafood to Russia.\29\ These exporters were selected
from nearly two hundred companies that applied for inspections from the
visiting Russian authorities.\30\
---------------------------------------------------------------------------
\27\ ``Russia names 11 qualified Vietnamese seafood exporters,''
Thanhnien News (Aug. 20, 2007).
\28\ ``Fisheries face tough export rules,'' Viet Nam News (Jan. 27,
2007) (``Fisheries Face Tough export rules'').
\29\ ``More seafood processors win Russian import license,''
Vietnam Economy (Sep. 18, 2007).
\30\ Fisheries face tough export rules.
---------------------------------------------------------------------------
European Union: In 2007, the EU conducted an on-site inspection of
Vietnamese seafood processors and the food safety system administered
by the Vietnamese government.\31\ The findings of the EU officials
conducting the inspection help to explain why every major seafood
importing market, besides the United States, is taking action to
address Vietnamese seafood exports. Specifically, the EU's final report
observed:
---------------------------------------------------------------------------
\31\ Final Report of a Mission Carried Out to Vietnam from 24
January to 1 February 2007 in order to Evaluate the Control of Residues
and Contaminants in Live Animals and Animal Products, Including
Controls on Veterinary Medicinal Products, European Commission, Health
& Consumer Protection Directorate--General, Directorate Food and
Veterinary Office, DG(SANCO)/2007/7322--MR Final, p. 5 (Feb. 2007).
---------------------------------------------------------------------------
The ongoing detections of veterinary drug residues in exported
consignments tested at EU border inspection posts raise concerns on the
effectiveness of residues controls which are weakened by the general
availability of drugs without prescription, the limited scope of
official testing, the capacity of the laboratory network, and, in some
cases, insufficient follow-up.\32\
---------------------------------------------------------------------------
\32\ Id. at p. 14.
---------------------------------------------------------------------------
Thus, the EU's report noted that valid concerns existed regarding
the ability of the Vietnamese government and its seafood producers to
prevent the export of seafood with harmful contaminants because drugs--
including antibiotics--are widely available without the need for a
prescription, and the limited scope of the government's ability to test
and follow-up on problems.
EU officials also determined that shrimp found to contain
antibiotics were not exported to the EU, but neither were the
contaminated shrimp destroyed,\33\ leaving open the possibility that it
was exported to other markets with less stringent enforcement (like the
United States). The EU's finding is all the more troubling given the
recent comments of Huynh Thi Thanh Giang, the Deputy Director General
of An Giang Seafood Import-Export Company, a large Vietnamese exporter
of seafood, in the Vietnamese press. Mrs. Giang noted that products
rejected from importing countries ``cannot be consumed domestically''
and that ``[t]he only way for enterprises to minimise losses when
products are discovered as containing antibiotics, according to Mrs.
Giang, is to look for easier-to-please markets.'' \34\ As between
Canada, the EU, Japan, and the United States, the ``easier-to-please
market'' is the United States.
---------------------------------------------------------------------------
\33\ Id. at p. 9.
\34\ ``Unsafe Seafood Exports: No Solutions?,'' Vietnam Economy
(source: Sai Gon Tiep thi) (July 27, 2007).
2
---------------------------------------------------------------------------
Markets in the EU, Japan, Canada, and the United States account for
roughly 90 percent of Vietnam's average annual 268 million pounds of
shrimp exports. At the same time that every other major market for
Vietnamese shrimp has expressed concerns about the safety of the
country's seafood products and has taken action to rectify these
problems, the United States, which receives approximately one-third of
Vietnam's shrimp exports, has taken no significant action.
In fact, while every other major market has found repeated
shipments of Vietnamese shrimp tainted with banned antibiotics, a
review of the FDA's import refusals indicates that the agency did not
refuse a single shipment of Vietnamese shrimp based on the presence of
antibiotics in the past year.\35\ At the same time, a comparison of the
Vietnamese exporters that have had seafood products refused from the
Canadian and Japanese markets with the lists of Vietnamese exporters of
seafood to the United States (available through a subscription service)
demonstrates that many of these exporters continue to ship to the
United States unabated.\36\
---------------------------------------------------------------------------
\35\ Import Refusal Reports for OASIS By Industry, U.S. Food and
Drug Administration (Jan. 2007--Aug. 2007).
\36\ See Urner Barry's Foreign Trade Data (Seafood Import Data
Online) available at http://ftd.urnerbarry.com/.
---------------------------------------------------------------------------
At least since 2003, the FDA has had active knowledge of Vietnam's
pervasive use of chloramphenicol in aquaculture. At that time the FDA
recognized, in a letter sent in response to Citizens Petitions
regarding chloramphenicol in crabmeat, that ``there is abundant
evidence that chloramphenicol is still in widespread use abroad,
particularly in Southeast Asia.'' \37\ Specifically, the FDA detailed a
meeting it had with its Vietnamese counterparts, where:
---------------------------------------------------------------------------
\37\ Letter from the U.S. Food and Drug Administration to Olsson,
Frank, and Weeda, P.C., Re: 02P-0321, p. 22 (Jul. 29, 2003) (``FDA
Chloramphenicol Decision'').
---------------------------------------------------------------------------
[D]uring a March 5, 2003 meeting with Vietnam [and the FDA],
Vietnamese government officials reported that they continue to have
problems with chloramphenicol being used in the production of shrimp in
their country, and they have acknowledged the use of chloramphenicol in
shrimp farming.\38\
---------------------------------------------------------------------------
\38\ Id. at p. 11 (emphasis added).
---------------------------------------------------------------------------
Despite this explicit knowledge and the continued, current findings
of antibiotics in Vietnamese shrimp in other markets, the FDA has yet
to issue a country-wide import alert on Vietnamese shrimp imports. As a
result, Vietnam is now the third largest exporter of shrimp to the
United States.\39\
---------------------------------------------------------------------------
\39\ U.S. Census Bureau, IM-145, U.S. General Imports (July 2007).
---------------------------------------------------------------------------
The significant amount of shrimp imports that the U.S. received
from Cambodia between 2004 and 2006 provide another example of how the
FDA has largely ignored or paid little attention to the food safety
concerns voiced by equivalent agencies in other major seafood importing
markets. Cambodia cannot export seafood to the EU. In a bid to obtain
access to the EU market, Cambodia invited EU authorities to conduct an
on-site investigation of seafood processing plants in the country in
2005. The EU officials found that (1) Cambodian regulatory officials
did not have the legal authority to perform checks of facilities for
food safety compliance; (2) processing facilities with ``very poor
hygiene situation''; and (3) worse, Cambodia's entire process of
certifying the food safety of export shipments was a sham.\40\
---------------------------------------------------------------------------
\40\ See Final Report of a Mission Carried Out in Cambodia from 19
to 30 September 2005: For the Assessment of the Conditions of
Production of Fishery Products Intended to be Exported to the European
Union, European Commission, Health & Consumer Protection Directorate-
General, Directorate F--Food and Veterinary Office, DG(SANCO)/7765-
2005-MR (Oct. 2005) (``EU Report on Cambodian Fishery Products'').
---------------------------------------------------------------------------
Specifically, EU officials reported that Cambodian officials
providing certifications as to the safety and fitness of exported
seafood ``could not have the knowledge of, and could not have the
possibility to ascertain and verify the matters they are certifying,
which is against the international standards in the field of
certification.'' \41\ Based on these findings, the EU continued to
prohibit Cambodian seafood exports from entering the EU market.
---------------------------------------------------------------------------
\41\ Id. at p. 8.
---------------------------------------------------------------------------
A review of Cambodia's export statistics between 2002 and 2006
indicates that, at the same time as the EU found that Cambodia's
processing plants had very poor hygiene and were accompanied by false
certifications to export markets, Cambodia exported over 22 million
pounds of shrimp to the world.\42\ Ninety-nine percent of that shrimp
was exported to the United States. U.S. import statistics show that
between 2004 and 2006, the United States imported 21.7 million pounds
of shrimp from Cambodia.\43\ Thus, while the EU refused to accept any
seafood products from Cambodia because of the dangers posed by these
products to consumers in the EU, substantial quantities freely entered
the United States.
---------------------------------------------------------------------------
\42\ ``Cambodian Exports to the United States: January 2002 to July
2007,'' Dialog TradStat (2007).
\43\ Id.
---------------------------------------------------------------------------
Despite the very significant and real risks posed by this country's
lax seafood import safety rules, invariably, whenever anyone calls for
significant improvement of our laws, certain parties argue that an
improvement of U.S. food safety laws would be ``protectionist'' and
potentially violative of this country's international trade
obligations. Such assertions are simply incorrect. The FDA's regulatory
oversight of imported seafood lags substantially behind those employed
in other countries (and the oversight of the USDA). Accordingly, any
improvement in the FDA's regulatory authority would, at most, simply
bring the U.S. in line with international best practices. Moreover, as
the FDA has previously recognized,\44\ Article XX of the General
Agreement on Tariffs and Trade (``GATT'') explains that nothing in the
GATT prevents a nation from adopting or enforcing any measure
``necessary to protect human, animal, or plant life or health. . . .''
\45\ Accordingly, the improvement of FDA's regulatory program related
to the safety of imported seafood would not be inconsistent with our
international trade obligations.
---------------------------------------------------------------------------
\44\ FDA Chloramphenicol Decision at p. 22.
\45\ General Agreement on Tariffs and Trade, Oct. 30, 1947, 61
Stat. A-11, 55 U.N.T.S. 194. User fees for import inspection are also
specifically allowed in our WTO commitments. Article VIII of the GATT
specifically contemplates and allows for fees to be charged for the
``analysis and inspection'' of imported goods so long as the fees are
``limited in amount to the approximate cost of services rendered and
shall not represent an indirect protection to domestic products or a
taxation of imports or exports for fiscal purposes.''
---------------------------------------------------------------------------
The bogus ``international obligation'' argument offered by
importing interests masks the true trade effects of our weak imported
seafood safety regulatory regime: the failure to effectively regulate
seafood imports creates irresistible incentives for exporters to ship
unsafe seafood products to the United States.
As trade statistics demonstrate, the incentives created by the FDA
for foreign producers to export unsafe products is not simply a matter
of conjecture. The consequence of stringent import regimes of other
major shrimp importing countries coupled with the FDA's lax enforcement
of U.S. food safety standards puts U.S. consumers at grave risk, as the
United States has become a magnet for unsafe and contaminated shrimp
imports. When other major importing markets take action against unsafe
seafood products, those products are diverted to the United States.
There is a direct cause and effect between market closures or
restrictions on imports in major importing countries and the diversion
of contaminated and likely contaminated products to the United States.
The fact that the United States' failure to implement a strong
safety program with regard to imported seafood creates incentives for
exporters to ship harmful product to this market is widely recognized.
In an op-ed piece published this summer in the New York Times, author
Taras Grescoe observed that ``if you're a shady seafood dealer trying
to unload a container of dodgy shrimp or tilapia, chances are 98 in 100
it will make it into the United States.'' \46\ Indeed, even the
organization representing U.S. seafood importing interests, the
National Fisheries Institute, has argued that foreign seafood packers
will ship to the market of least resistance.\47\ In opposing provisions
that would allow the FDA to destroy unsafe seafood imports, the
National Fisheries Institute argued that any such ``provision could
cause significant restraint of international trade because suppliers in
other countries may elect to avoid the U.S. marketplace rather than
face possible destruction of their product.'' \48\ It follows,
therefore, that because other major seafood importing markets have the
ability to destroy unsafe seafood imports while the National Fisheries
Institute has successfully opposed the FDA adopting any such authority,
suppliers in other countries elect to ship potentially unsafe product
to the U.S. marketplace rather than face possible destruction of their
product in other markets. Thus, the most disastrous consequence of the
FDA's inability to administer a meaningful seafood import safety
program is that the agency's regulatory failure acts as a magnet for
attracting unsafe imports to this country.
---------------------------------------------------------------------------
\46\ T. Grescoe, ``Catfish With a Side of Scombroid,'' New York
Times (July 15, 2007).
\47\ Letter from National Fisheries Institute to the U.S. Food and
Drug Administration, FDA Docket No. 2000N-1633 (May 14, 2001), p. 4
(claiming that ``U.S. food safety standards are, in many cases, more
restrictive than those of other countries.'') (``2001 National
Fisheries Institute Letter'').
\48\ Id.
---------------------------------------------------------------------------
Examples help to illustrate the trade effects of our weak imported
seafood safety regime. In November 2001, a routine on-site inspection
of Chinese production facilities by EU officials ``revealed serious
deficiencies of the Chinese residue control system and problems related
to the use of banned substances in the veterinary field.'' \49\ In
addition, EU border inspection officials found repeated shipments of
Chinese shrimp imports contaminated with chloramphenicol.\50\ As a
result, the EU banned all shrimp, honey, mollusks, rabbit and poultry
meat, and pet food imports from China in January 2002.\51\ Following a
30-month ban of Chinese shrimp imports, in July 2004, the EU agreed to
recertify Chinese shrimp imports only after the Chinese government
guaranteed that it would test 100 percent of Chinese shrimp exports
bound for the EU, and that it would ship only certified consignments
that met the EU's food safety standards.\52\
---------------------------------------------------------------------------
\49\ ``EU Standing Veterinary Committee agrees on suspension of
imports of products of animal origin from China,'' Press Release,
European Commission, IP/02/143 (Jan. 28, 2002).
\50\ Id.
\51\ Id.
\52\ ``EU eases food imports from China after significant
improvements in veterinary standards,'' Press Release, European
Commission, IP/04/943 (July. 16, 2004).
---------------------------------------------------------------------------
As a direct result of the EU's 30-month ban, shrimp exports from
China were diverted from the EU market and flooded the U.S. market. As
Chinese exports of shrimp to the EU fell, shrimp exports to the United
States exploded, leading to a 30 percent increase of Chinese shrimp
exports to the United States from 2002 to 2003.\53\ The influx of
Chinese shrimp imports began to abate only when the U.S. domestic
shrimp industry filed an antidumping petition to seek relief from these
dumped imports.
---------------------------------------------------------------------------
\53\ ``Chinese Exports to the United States: January 1999 to
January 2005,'' Dialog TradStat (2007).
---------------------------------------------------------------------------
More recently, in early 2007, the EU completed an on-site review of
seafood safety systems in Pakistan that revealed severe deficiencies in
the country's food safety oversight and controls.\54\ Based on these
findings, the EU decertified all seafood producers from Pakistan in
April 2007. In keeping with these actions, a review of export
statistics from Pakistan shows a substantial decline in monthly shrimp
exports from Pakistan to the EU, resulting in no reported exports of
shrimp to the EU in June 2007.\55\
---------------------------------------------------------------------------
\54\ See Final Report of a Follow-Up Mission Carried Out in
Pakistan from 22 to 26 January 2007: In Order to Evaluate the Control
Systems in Place Governing the Production of Fishery Products Intended
for Export to the European Union, European Commission, Health &
Consumer Protection Directorate--General, Directorate Food and
Veterinary Office, DG(SANCO)/2007-7298--MR Final (Jan. 2007) (``EU
Report on Pakistan'').
\55\ ``Pakistani Exports to the United States: July 2006 to July
2007,'' Dialog TradStat (2007).
---------------------------------------------------------------------------
At the same time, predictably, Pakistan's shrimp exports to the
United States skyrocketed in June 2007. The value of shrimp exports to
the United States from Pakistan in June 2007 was larger than the
monthly value of Pakistani shrimp exports to the United States in any
previous month since 2005 and more than twice the monthly average value
for Pakistani shrimp exports to the United States.\56\ Again, while the
EU has refused to accept shrimp products from Pakistan because of the
dangers posed by these products to consumers in the EU, significant
quantities have begun to enter the United States, apparently
unhindered, and will likely continue to be shipped to this country.
---------------------------------------------------------------------------
\56\ Id.
---------------------------------------------------------------------------
We understand that certain parties oppose implementation of an
effective and meaningful imported seafood safety program. We realize
that importers will fight against any oversight of their activities, as
they have for the last decade. Nevertheless, whatever empty promises
seafood importing interests make now--similar to promises made years
ago--and whatever political pressure they bring to bear to oppose
meaningful reform, they cannot change the fact that their rabid pursuit
of a greater profit has placed the consumer in unnecessary peril.
Changes necessary to ensure the safety of our food supply cannot be
derailed by importers' claims that their costs may increase under
meaningful regulations. Indeed, in the wake of revelations regarding
numerous imported food safety problems, U.S. consumers have made it
clear that they are willing to pay a bit more if it means they can be
assured of uncontaminated and safe food.\57\
---------------------------------------------------------------------------
\57\ ``You Are What They Eat,'' Consumer Reports (July 2007)
(``American consumers are willing to pay more for greater safety
guarantees. . . .'').
---------------------------------------------------------------------------
Our government must safeguard the quality and integrity of our
Nation's food supply. With imported shrimp, Americans cannot be sure
what it is they are eating. Farm-raised in crowded and dirty ponds,
with almost no quality control, imported shrimp develop in poor
sanitary conditions, in ponds with high feces concentrations, banned
antibiotics, and toxic chemicals.\58\ As a result, imported shrimp
often contain harmful antibiotics, pesticides, salmonella, and filth.
Consumers rely on the FDA to ensure that the imported seafood products
that reach U.S. shores are not so contaminated.\59\ Under current
circumstances, that reliance is misplaced. Extra profits for the few
cannot and must not come at the risk of the safety of the many.
---------------------------------------------------------------------------
\58\ See ``Shrimp's Success Hurts Asian Environment, Group Says,''
National Geographic News (Dec. 20, 2004) (discussing the Environmental
Justice Foundation's ``concerns over the levels of antibiotics,
disinfectants, fertilizers, pesticides, and other chemicals used by
shrimp farmers to maximize profits and combat disease.''); Global and
Local: Food Safety Around the World, Center for Science in the Public
Interest, pp. 14-16 (June 2005); ``Chicken from China?,'' Boston.com
(May 9, 2007) (``In China, some farmers try to maximize the output from
their small plots by flooding produce with unapproved pesticides,
pumping livestock with antibiotics banned in the United States, and
using human feces as fertilizer to boost soil productivity. But the
questionable practices don't end there: Chicken pens are frequently
suspended over ponds where seafood is raised, recycling chicken waste
as a food source for seafood, according to a leading food safety expert
who served as a Federal adviser to the Food and Drug Administration.'')
(emphasis added).
\59\ ``Fish Farming: Is it Safe for Humans and the Environment,''
17 CQ Researcher 27, p. 630 (July 27, 2007).
---------------------------------------------------------------------------
Thank you for allowing me to testify today. I am happy to respond
to any questions the Members of the Committee may have.
Chairman LEWIS. Thank you, Mr. Williams, for your
testimony.
Our next witness is Chris Knox, the vice president of Vest,
Inc. Welcome.
STATEMENT OF CHRIS KNOX, VICE PRESIDENT, VEST, INC., LOS
ANGELES, CALIFORNIA
Mr. KNOX. Thank you. Good afternoon. My name is Chris Knox
and I am vice president of sales and marketing for Vest
Incorporated, a domestic manufacturer of structural steel
tubing located in Los Angeles, California.
I am pleased to be here on behalf of our company and the
Committee on Pipe and Tube Imports, a non-profit trade
association which represents 38 producers nationwide.
This morning, I would like to offer my views about the
safety aspect of imports of steel tubing products from China. I
provide this information firsthand, as our company and many
others in the U.S. industry have confronted this safety problem
over the last few months. The examples I will share with you
will explain why this issue has a direct impact on the U.S.
consumer and why Congress and the appropriate Federal agencies
should take corrective actions to ensure that Chinese products
entering the U.S. meet our safety standards.
Like most in business, we take great pride in the quality
of products we make for our customers. These types of products
include rectangular structural tubing products used in the
construction of warehouses, mid-rise residential buildings
under 10 stories and other public buildings, including schools
and healthcare facilities. All these types of structures
require a certain high-strength steel to meet requirements for
construction. I could allude to the different types of specs
and metallurgical qualities that are required. But instead, I
will simply state in layman's terms that Vest and other U.S.
producers test their products to ensure that the product
specifications are met.
There is an international standards group, ASTM, that
establishes the bar for this testing. Once the product meets
these requirements, it becomes ASTM compliant.
As to structural tubing, the main specification is A-500
grade B, and it requires a minimum strength of 46,000 pounds
per square inch. To my knowledge, U.S. producers and foreign
producers previously selling in the U.S. market have always met
these standards. It is our responsibility.
However, we have learned by purchasing Chinese tubing from
independent steel service centers and having it tested by
independent laboratories, that significant quantities, as high
as 50 percent from some Chinese producers, have not met the
specifications, even though Chinese mills certify that they do.
A number of other U.S. producers located in various
geographical locations have performed similar testing with
similar results.
It is also important to note that China is our main
competitor today. Imports from China of all pipe and tube have
continued to soar. In 2006, a total of 2.1 million tons of type
and tube entered the U.S., up from a mere 128,000 in 2002.
Based on import data available through July, imports will grow
to about 2.8 million tons this year.
As to structural tubing, the product where we have observed
the most quality problems, China became the number two exporter
to the U.S. last year, but was the top foreign supplier in
July.
As I stated earlier, it is the normal course of business in
our industry to routinely perform a number of tests for
strength, durability and weld integrity before shipment to the
customer. If for some reason our product fails, it either
becomes scrap or is sold as secondary product. With regard to
imported materials, this responsibility is also placed on the
foreign producer.
It is important to note that the manufacturers must provide
detailed mill certifications to our service center customers,
who in turn provide them to their building contractor customers
to ensure that the engineering requirements are met. To us, it
appears that some Chinese producers are simply providing
fictitious mill certification.
Something must be done to ensure that these imports are
safe. If a weld on a product does not hold, the tube fails and
so might a roof section, or might a support section for a
pedestrian bridge. I also know that this safety problem has
expanded to scaffolding, a product which is also made from the
same products we produce.
This imported product has failed tests and has been
rejected by some U.S. companies. Unfortunately, there was an
accident involving the collapse of a scaffolding in southern
California this summer which is currently under investigation.
I would like to refer to the article entitled New Threat
From China, Shoddy Steel Imports, which appeared in the
September 7th edition of the Kiplinger Newsletter. As noted,
the article goes into detail about steel imports from China
failing and why fabricators and construction firms are more
than a little nervous about the implications of these safety
failures, because inferior high-strength steel could cause
catastrophic failures of buildings, pipelines and
transportation projects.
Unfortunately, these reports continue to grow.
We have raised this issue with Customs and Border
Protection was and the Federal Trade Commission. We have
provided test results and names of Chinese producers and
importers to the agencies to encourage them to intervene, to
ensure that the public safety is not compromised. To the
Members today, I would encourage you to take a serious look at
this issue and take the appropriate action to ensure that the
Customs Service can certify that products entering the U.S. are
indeed the product they claim to be.
I understand that Customs currently has only a few labs on
site at our Nation's top ports. I believe there should be
adequate resources directed by the agency to ensure that
testing can be done on site and the agency needs to have more
staff assigned at the ports to over see these activities.
In addition, legislation is needed to charge those
distributing unsafe products throughout our economy to be
personally accountable for the public safety.
I do hope that this Committee will be able to address this
issue and to direct the appropriate agencies to act quickly. To
date, there has been no official warning, advisory or recall of
unsafe building materials. Still, none of us ever wants to read
about a building collapse because of our failure to act.
Thank you.
[The prepared statement of Mr. Knox follows:]
Prepared Statement of Chris Knox, Vice President, Vest Inc.,
Los Angeles, California
[GRAPHIC] [TIFF OMITTED] 49993A.024
[GRAPHIC] [TIFF OMITTED] 49993A.025
[GRAPHIC] [TIFF OMITTED] 49993A.026
[GRAPHIC] [TIFF OMITTED] 49993A.027
[GRAPHIC] [TIFF OMITTED] 49993A.028
Chairman LEWIS. Thank you very much, Mr. Knox, for your
testimony.
Our next witness is Craig Thorn, a partner at DTB
Associates. Welcome, sir.
STATEMENT OF CRAIG THORN, PARTNER, DTP ASSOCIATES, LLP
Mr. THORN. Thank you Mr. Chairman, Members of the
Committee. I am here today to talk about U.S. obligations under
international agreements regarding the application of food
safety standards and other sanitary and phytosanitary measures.
The most important set of rules governing such measures are
found in the Agreement on the Application of Sanitary and
Phytosanitary Measures also known as the SPS agreement, which
was negotiated during the Uruguay round of trade negotiations.
The SPS agreement is a relatively simple collection of
rights and obligations. First and most fundamentally, it
explicitly recognizes the sovereign right of member countries
to impose measures that restrict trade in order to protect
health. Each country also has the right to determine its own
level of sanitary or phytosanitary protection, provided that
level of protection is appropriate to the risk concerned and to
apply that standard to imported products.
In return, member countries agree to base their SPS
measures on scientific principles, to ensure that they are
nondiscriminatory, and to refrain from imposing measures that
are more trade restrictive than necessary to achieve their
objective.
The agreement encourages countries to base their SPS
measures on international standards where those standards
exist. However, members are free to impose measures that result
in a higher level of protection than that afforded by the
international standard, as long as those measures are based on
sound science.
In cases where countries face a risk about which scientific
information is insufficient, that country is free under the
agreement to adopt a provisional, precautionary measure, based
on available information, provided it works to obtain
additional information it needs to make a more informed
decision within a reasonable period of time.
The SPS agreement has been a useful tool for U.S. exporters
of agricultural products. As tariffs and other conventional
trade barriers have been reduced or eliminated in recent years,
some countries have replaced those barriers with questionable
SPS restrictions, often in response to pressure from activists
or business interests. The SPS agreement is useful in such
cases because it establishes an objective standard of
legitimacy for SPS regulations.
U.S. trade officials have been able to use the leverage of
the SPS trade rules to challenge illegitimate measures and open
markets for U.S. exports.
Some have criticized SPS trade rules, claiming that they
force countries to accept unsafe products. I would like to list
some of the points these critics have made and respond to them
briefly.
First, some critics claim that the SPS agreement limits the
ability of U.S. regulators to set domestic safety standards. In
fact, the United States is free under the SPS agreement to
determine its own level of protection against food safety
risks, as long as that level of protection and the measures
used to reach it are scientifically defensible. The United
States can impose that standard on imported food and
agricultural products, provided the same standard is also
applied to domestic products.
I have never heard a regulator in the United States or any
other country make the claim that these rules adversely affect
a country's ability to protect its consumers.
A second claim, that the equivalence obligation under the
SPS agreement forces the United States to rely on foreign
regulatory systems to ensure the safety of imported food. This
claim is also unfounded. Nothing in the SPS agreement requires
countries to delegate the job of ensuring food safety to
foreign regulators. WTO members are obliged to recognize
foreign SPS measures as equivalent only if the exporting
country is able to demonstrate to the importing country
objectively that the measure meets the standards of the
importing country. The importing country is then free to
continue monitoring imports and to revoke an equivalency
determination if appropriate.
Criticism number three, the United States is vulnerable to
challenges under the SPS agreement if it changes its
regulations or acts to block unsafe imports. In actual fact, no
U.S. SPS measure has ever been challenged under the SPS
agreement. Indeed, there have been just six dispute settlement
panels under the agreement since it entered into force 12 years
ago.
One reason for the infrequency of cases is the degree of
latitude the agreement affords to domestic regulators.
Countries recognize that challenges are unlikely to be
successful--sorry, are likely to be successful only where
violations are particularly clear cut. The rulings in the cases
that we have seen thus far underscore that fact.
Finally, critics claim that U.S. free trade agreements,
bilateral free trade agreements, aggravate the problem by
facilitating imports from FTA partners. Now, it is true that
certain U.S. FTAs, including the four that are currently
awaiting congressional action, include a section on SPS
measures. However, those provisions simply affirm the rights
and obligations of both parties under the SPS agreement and
establish a standing Committee to assist in resolution of SPS-
related trade problems. The agreements do not confer additional
rights nor impose additional obligations. In other words, the
rules of the SPS agreement continue to govern trade between
parties to the FTA.
To be clear, I am not arguing that there is no need to
examine the U.S. system for ensuring the safety of food
imports. However, I believe that the problems and
vulnerabilities that have been identified are not the result of
constraints imposed by international trade rules. The United
States has plenty of latitude under those agreements to ensure
the safety of food imports. The only real constraints are the
amount of emphasis the FDA and USDA place on the issue and the
resources allocated by Congress.
Thank you.
[The prepared statement of Mr. Thorn follows:]
Prepared Statement of Craig Thorn, Partner, DTB Associates LLP
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Chairman LEWIS. Thank you very much for your testimony.
Our final witness is a good friend, wonderful friend,
former colleague of ours, the Honorable Cal Dooley, from the
great state of California. He is the president and chief
executive officer of the Grocery Manufacturers Association.
Welcome, Cal
STATEMENT OF THE HONORABLE CAL DOOLEY, PRESIDENT AND CHIEF
EXECUTIVE OFFICER, GROCERY MANUFACTURERS ASSOCIATION AND FORMER
REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA
Mr. DOOLEY. Well, thank you, Mr. Chairman. I am delighted
to be joining all of you and I really have the honor of
representing over 350 food, beverage and consumer products
companies that manufacture tens of thousands of products.
You know, every day, your constituents and our customers
throughout the country visit thousands of stores. Every time
they go in to one of the grocery stores, they see literally
100,000 different products. The member companies I represent
are very pleased and are very proud of the fact that the
overwhelming majority of those products are consumed by
consumers every day without posing any threat to the safety of
their families.
But we would acknowledge that, due to some of the recent
events, that there is more that we can do, and, in fact, can
institute some new practices, that can further enhance the
safety of the products that we are providing to consumers.
That is what led the Grocery Manufacturers Association to
issue a ``Commitment to Consumers: The Four Pillars of Food
Safety''. What we have introduced is a proposal to work in
partnership with the regulatory community and the Federal
Government, to have a public/private partnership where we can
enhance the safety of the food products. It is a proposal that
is based more on prevention rather than on inspection. We don't
believe it is possible to give FDA the resources it would need
to elevate the rate of inspection that you could, in fact,
markedly improve the safety food. A far better investment is
relying on the expertise and the capacity of the private sector
to do a better job on the prevention.
The way we do that is, is that we suggest that we should
develop a mandatory foreign supplier quality assurance program,
that would require any importer of record to have a defined
program that would be consistent with the guidance that would
be developed by FDA, that would ensure that we would have a
record of audits from a supplier of an ingredient or product
internationally, that we would maintain the track of that
product throughout the supply chain, that we would have testing
protocols that would be developed to ensure that that product
is, in fact, safe when it comes inside our borders.
We would also have a second pillar that would ensure that
we could provide an opportunity for suppliers and manufacturers
of products to go an additional step, to share additional
information with FDA that could give them greater confidence
that the products that they are providing consumers pose less
of a risk.
Our whole objective here is that, really, when you look at
the incidence of food safety problems in this country it is
like finding the needle in the haystack. What our objective is
on pillar one is to reduce the number of needles, the number of
problems that are in our food supply. The objective in the
number two is how do we reduce the size of the haystack so that
FDA can be targeting their inspection focus on those products
and those practices that could pose the greatest risk.
Our third pillar is really focused on the need for us to
invest in developing the capacity in some of the exporting
countries so that they can, in fact, have regulations that are
more consistent with those in the United States and also have
the ability to do a better job enforcing compliance with those
standards. This is something that both the private sector and
the public sector can commit and can do a better job of.
Our pillar four is one which is shared by all the
stakeholders of FDA, whether you are a patient advocacy group,
whether you are a consumer interest group, or whether you are a
food, a cosmetic manufacturer or pharmaceutical manufacturer.
We need to increase the funding for FDA. We are committed in,
the Coalition for a Better FDA, to try to double the funding of
FDA over the next five years.
You know, Mr. Thorn did an excellent job, I think, touching
on the issues related to whether or not we are in any way
constrained by enhancing the food safety programs in the United
States by our free trade agreements. That is absolutely not the
case in any instance. As long as we are applying an equivalent
standard to those products that are coming--from outside our
borders as well as to domestic products, we face no problems.
I just want to touch on a few concerns that we have with
some of the legislative proposals that have been introduced by
some of your colleagues in Congress. One is calling for user
fees for imported products. I would say that this is a proposal
that we have serious objections to. We have objections to it
because we have never seen a user fee that could be applied in
an equitable manner and that also wouldn't undermine the
credibility and the integrity of our inspection program.
We also think it might have some adverse and unintended
consequences. Just to give you an example of that, I brought in
two different food products. We have this one product, Madras
lentils, that is a product of India. I have another product
here which is a vegetarian chili, which is manufactured in
Napa, California, actually.
This product from India, if it was imported into the United
States, would pay one user fee of $50 a line item, under the
proposed legislation.
This product that was manufactured in the United States
could have included ingredients that might number as high as
20. If 10 of those ingredients were imported from outside the
borders of the United States, they would be paying a $50 line
item import fee on half the products that are in this. You
would actually be creating a perverse incentive for
manufacturers to manufacture a product in Mexico, or in Canada,
rather than in the United States with an application of a user
fee that would have these type of consequences.
So, I would just encourage certainly the Committee on Ways
and Means to be diligent when you see a user fee, which might
actually be construed as a tax, and should be under your
jurisdiction, about how we approach these.
In closing, I would just say that, you know, the member
companies I represent are absolutely committed to working in
partnership with you, with people at the FDA, to ensure that we
can, in fact, enhance the safety of the products that we are
providing to consumers. I thank you for the opportunity to
testify.
[The prepared statement of Mr. Dooley follows:]
Prepared Statement of The Honorable Cal Dooley, President and
Chief Executive Officer, Grocery Manufacturers Association and former
Representative in Congress from the State of California
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Chairman LEWIS. Thank you very much for your testimony this
morning. I thank each Member for your patience and for being
here and being willing to testify.
At this time, I will open the panel for questions. I ask
that each Member follow the 5-minute rule. If each witness will
respond with short and concise answers, all of the Members
should have the opportunity to ask questions.
Ms. Halloran, were you or any other consumer rights
advocate organization consulted by the interagency working
group on import safety? Did anyone get in touch with you or any
other group that you know and ask for your advice or ideas?
Ms. HALLORAN. Very late in the process, they had a meeting
with about a half dozen consumer groups. However, I didn't see
any evidence of our input in the report that they brought out.
We were very disappointed in the report because it was so vague
and general and really included no specifics about including
either resources or budgets to the agencies that need them,
just more about strategies and frame works.
Chairman LEWIS. Would any of you like to respond? If you
could recommend a single best action practice that the U.S.
Government should take to improve the safety of food and
product imports, what would it be? What recommendation would
you give?
Ms. HALLORAN. At this point, I think the best measure that
they could take without a budgetary impact, I mean, we need to
have more inspection, but we also need to have independent
third party certification and we need it to be required. That
applies to consumer products and food products. It needs to be
government supervised and that would allow us to have some
method for making sure that products coming into the country do
meet our standards and that the standards are being imposed in
the country of origin, not just at the border.
Chairman LEWIS. Anyone else care to respond?
Mr. DOOLEY. Yes, I will, Mr. Chairman. I guess people need
to step back and just look at who has the greatest vested
interest in insuring that their product is not going to pose a
safety risk to consumers? I mean, that company that has their
brand name on it is absolutely committed because any time there
is a recall or a problem that is a result of a food safety--
with their product out there, it has significant financial
impact.
All of our companies today that are acting responsible are
in fact employing third party audits that are ensuring that the
suppliers of their ingredients are, in fact, meeting some
standards that have been identified as providing that level of
safety that is appropriate.
So, that is where we think that FDA should be in a role
where they can cooperate with a private sector who is in fact
using audits that have some defined standards in order to meet
that higher level of certainty that these products won't pose a
risk.
Chairman LEWIS. Mr. Berman, in your view, why haven't OSHA
and the CPSC been more aggressive in their testing of textile
products containing dangerous substances or dangerous material?
Mr. BERMAN. Well, in the instance of OSHA, it is--consumer
protection is not within their jurisdiction; they are
protecting workers in the work place. They, in recent years,
have not had the budget to do proactive inspections within
plants. They--the effect that we have had since the OSHA
standards have been imposed in the U.S. has been indirect. The
fact that the work places had to meet the OSHA standards had a
carryover effect and products that were produced in the U.S.
were--had formaldehyde at safe levels for consumers. It is
since globalization that we have gone back a step.
The CPSC has the same problem. In each instance, they need
a complaint before they are going to take action. There is
nobody minding the store.
Chairman LEWIS. Are you suggesting that before they take
action, there must be a particular complaint? Must someone wait
to be harmed or something serious happen to a person before
someone takes some action?
Mr. BERMAN. Well, with respect to the formaldehyde in
textiles, there is no U.S. standard right now, so in that case,
you are going to have to wait for an actual harm. So, I think
really what needs to be done first is that there needs to be
some rulemaking and perhaps the CPSC should be empowered to do
some investigative work to determine the extent of the problem.
I only spoke about the products that we have actually
tested. But I know anecdotally from talking to other people in
the textile industry, that apparel is full--that is coming in
from China and other Asian countries is full of formaldehyde.
The same blankets that were recalled in Australia and New
Zealand are coming into the U.S. Formaldehyde is not the only
dangerous substance in products, in textile products coming to
the United States.
Friends who are in the stocking industry have tested
stockings where they are asked by the retailers, gee, why can't
you give us the same vibrant colors that we are getting from
India and Pakistan? After they test them, say said, it is
because they have formaldehyde binders putting the pigments--
holding the pigments on. We are not allowed to use high
formaldehyde in the United States.
So, it is a much bigger problem and it is one that I think
people are generally unaware of.
Chairman LEWIS. Well, thank you very much. I notice that my
time had expired, but I just wanted to suggest that the
Associated Press had an article on Sunday that noted the
Japanese may have the strictest food standards of anyplace in
the world and that the Chinese have approached Japan to help
address many of their standard issues.
I would like to enter this article into the record.
[The information follows:]
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Chairman LEWIS. Now I turn to the Subcommittee on Trade
Ranking Member, Mr. Herger, for his questions.
Mr. HERGER. Thank you very much, Mr. Chairman. I have a
question I would like to ask of both Mr. Connelly and Mr.
Dooley as you represent your organizations.
Mr. Dooley, it is great to see you back. Thank you for the
years of representing our common state of California. It is
good to see you doing so well in your life after Congress.
Thank you for testifying here.
I would like to follow up on some comments that you made in
your testimony. Could you describe the process that your member
companies use to ensure the safety of the products they produce
and import? How can the Federal government incorporate such
processes in its development of a strengthened food and safety
regime?
Mr. DOOLEY. Just this week, Monday and Tuesday, we held a
conference, a global sourcing conference, where we brought in
representatives of our companies to talk about some of the best
practices that they were employing today, and what we could do
to even enhance those best practices. That is what we are
suggesting should become mandatory and developed as FDA
guidance under our Pillar One.
What we would suggest that would be components of this, and
these are still in development, that you would have a
requirement that there would have to be a supplier audit that
would have to be done on site at the source where you are
procuring the ingredients or the products that you would be
importing into the United States. That that audit would have to
have certain standards that would have to be complied with. We
would also have provisions that would ensure that you would be
able to maintain the chain of custody for that product when it
came into the United States.
We would further suggest that there are going to be the
need to develop certain testing protocols for some products.
They wouldn't be necessarily uniform for every product you are
bringing in. But some testing protocols that would--could be
determined, you know, or could mitigate the risk of
contamination.
We are also considering further development in terms of
would we have the same requirement for the development of HACCP
plans that are currently in place for domestic products. So
there are a host of issues here that we know--some of which and
many of which are being employed today by the companies that
are utilizing the best practices. What we are suggesting, we
ought to mandate those to apply to all companies, all importers
of record, regardless of their size or what products they are
engaged in importing.
Mr. HERGER. Thank you. I think that makes a great deal of
sense. I think the idea that it is your name on this product,
and I think we get the best use of our dollars if we can have
those of you who are most affected to a great degree be the
ones that are helping to enforce this.
Mr. DOOLEY. Well, we would agree most heartily. We can
double the budget of FDA, and it is still going to have limited
resources. So, the challenge, I think, you face is, how do we
define that role of the private sector and the FDA so that FDA
can invest their capacity in a way that is going to make the
greatest difference.
We think that there is an appropriate inspection role for
FDA there. But this idea of them going into importing countries
and certifying their labs, you--when I was on and testified at
Energy and Commerce just last week, Dr. Acheson said there is
as many as maybe 400,000 facilities that are producing
ingredients and food products in China. Not all these are
importing in the United States. But the thought that you would
have FDA having the resources to go in to China and certify
100,000 facilities, it is just not feasible in terms of being
financially viable. That is where we think the private sector
has the better opportunity to do that effectively.
Mr. HERGER. Well, we obviously have to do both, but what is
important, I think the point that you are making is that we do
what we can do the most effectively from both parts of
government and the private sector.
Mr. Connelly, would you like to comment on the same
question?
Mr. CONNELLY. Interestingly, our organization came up with
an approach very much like Mr. Dooley's independently. Right
now there are inspections required of both domestic and
imported seafood under what's called HACCP. An importer has a
requirement to ensure that his export partner overseas follows
a HACCP plan.
We would go one step further, though, in a parallel program
to the GMA program and actually require certification of an
importer here in the U.S. My 16-year-old son is getting his
drivers license and he has done 40 hours of classroom work to
do that. He drove me down to Gonzaga this morning, which is
always exciting to have a 16-year-old drive you when he has his
permit.
But he will actually have more requirements placed on him
to get his drivers license than it does to become a food
importer. We think we should tighten up that requirement.
Those companies, like our members, that spend time in Latin
America, spend time in Asia, ensuring that their partners do
the right things, should be rewarded. We think having a list of
certified importers is one step toward that. We think it also
will help FDA identify those companies that import a lot or
import a little and then they can target their resources
appropriately.
Mr. HERGER. I thank you have much.
Chairman LEWIS. Now I turn to the Chairman of the
Subcommittee on Trade, Mr. Levin, for questions.
Chairman LEVIN. Well, as you know, we have a vote and I'm
sorry I had to leave the room for a bit.
I know an issue is the balance between the public and the
private sectors. I just want to say--let me just ask you how
many of you watched the interagency process up to now are
optimistic about the results? Are all of you? Ms. Halloran, you
are not?
Ms. HALLORAN. As I mentioned just a moment ago, we are very
disappointed.
Chairman LEVIN. All right, I'll read the record.
Anybody else? Yes.
Mr. DOOLEY. Yes, Mr. Chairman, we are optimistic that the
interagency working group is going to offer suggestions that
are going to provide a road map for us to enhance a level of
products that we are importing. There is going to be a lot of
work that is going to continue to be done. We are looking at
this as--there is not a short-term, quick fix solution out
there. This is something that we are going to have to continue
to work on over an extended period of time.
Chairman LEVIN. All right. But let me just say my reaction
to the first panel was there did not seem a sense of urgency. I
know that nothing will be done completely short term. But if
the status quo or anything close to it remains and there is
another or a rather explosive event--I don't mean militarily--
the public will lose still more patience with us. It wouldn't
take much more to diminish the impatience of the public.
I think it has been a useful hearing. You haven't had a
chance to----
Mr. HULSHOF. I've got a couple of quick questions if I
might.
Chairman LEWIS. The gentleman, my friend and colleague from
Missouri is recognized, Mr. Hulshof.
Mr. HULSHOF. Thank you, Mr. Chairman. I am beginning to
think that there is a conspiracy afoot that just as I begin to
get to my questions, that the votes are being called. So, let
me be directly to the point.
Ms. Halloran, can you point to any instance where a free
trade agreement has required the United States to relax its
safety standards? The reason for my question is, the previous
panel had representatives from the U.S. Trade Representative,
Department of Homeland Security, U.S. Department of
Agriculture, the Food and Drug Administration and the U.S.
Product Safety Commission and none of those individuals could
ever point to an instance where we had--the United States had
to relax any part of its inspection regime. Do you differ with
their opinions?
Ms. HALLORAN. Our concern is--we do have--that has--that
has not happened, but many things have given us concern. One
is, for example, a challenge under NAFTA that was brought by a
Canadian corporation under Chapter 11.
Mr. HULSHOF. I am familiar with your testimony. So that has
been part of the record.
Ms. HALLORAN. Right.
Mr. HULSHOF. Go ahead.
Ms. HALLORAN. But we are more concerned about the--our
concern about the equivalence part of the trade rules is that
many of the rules in the U.S. are--are guidance, they are
voluntary standards. We have companies who voluntarily have
good performance so we haven't had a need to regulate and put
out rules.
For example, on formaldehyde, we don't have a formaldehyde
problem. So we don't have regulations. As a result, we can
require equivalence, but that doesn't get us anywhere in terms
of the foreign companies. We can't force on them standards that
are adhered to by custom and voluntarily here.
Mr. HULSHOF. Right. I appreciate that. I would point for
the record, Mr. Chairman, we won the case under which--that is
cited by Ms. Halloran that was brought.
You also suggest that we should harmonize up, and you give
as an example, rightly so, this protracted dispute that we have
had, for instance, with beef to Japan.
I would point out again for the record, Japan's herd is
four-and-a-half million animals. We slaughter 36 million
animals annually in the United States. Yet there is a 500
percent higher BSE tests in Japan than in the United States.
Yet you seem to take the USDA to task for not allowing private
companies to do BSE tests. In fact, how do you square that
inconsistency, because you want more rigorous standards and yet
the private companies providing BSE tests don't have as
rigorous a test as USDA, do they?
Ms. HALLORAN. The U.S. companies supplying the Japanese
market wished to use exactly the test that USDA uses when it
conducts tests.
Mr. HULSHOF. Okay.
Ms. HALLORAN. USDA refused to license them or to allow them
to use it to meet the demand of the Japanese customers.
Mr. HULSHOF. Final question, because again, once again,
time is short on the vote, I noted your concern with for
instance counterfeiting Underwriter Laboratories labels. Does
the consumer union of which you represent here today, have you
all expressed a similar concern about the importation of
pharmaceuticals or counterfeiting of pharmaceuticals coming
into this country?
Ms. HALLORAN. I don't believe we have a position on that.
Mr. HULSHOF. Thank you Mr. Chairman.
Chairman LEWIS. I thank the gentleman.
I would like to take the opportunity just to thank each and
every one of you for your participation, for being here and
being so patient. The Oversight and Subcommittee on Trades
appreciate hearing your views on how we can improve import
safety.
Is there any other business to come before the
Subcommittees?
There being no further business, this hearing is now
adjourned.
Thank you very much.
[Whereupon, at 1:27 p.m., the Subcommittees were
adjourned.]
[Submissions for the Record follow:]
Statement of AdvaMed
We thank the Committee for holding this Hearing today on Import
Safety. AdvaMed represents over 1,600 of the world's leading medical
technology innovators and manufacturers of medical devices, diagnostic
products and medical information systems. Our members are devoted to
the development of new technologies that allow patients to lead longer,
healthier, and more productive lives. Together, our members manufacture
nearly 90 percent of the $86 billion in life-enhancing healthcare
technology products purchased annually in the United States, and nearly
50 percent of the $220 billion in medical technology products purchased
globally. Exports in medical devices and diagnostics totaled $25.5
billion in 2005, and imports were $23.7 billion. The medical technology
industry directly employs about 350,000 workers in the U.S.
The medical technology industry is fueled by intensive competition
and the innovative energy of small companies--firms that drive very
rapid innovation cycles among products, in many cases leading new
product iterations every 18 months. Accordingly, our U.S. industry
succeeds most in fair, transparent global markets where products can be
adopted on their merits, and intellectual property rights are
protected. We strongly support the Administration's effort to expand
market access for U.S. products abroad through the World Trade
Organization (WTO) negotiations and new free trade agreements (FTAs),
as well as oversight of market access barriers in countries with which
we have strong trade relationships. In addition, we believe U.S.
participation in trade agreements is most effective when provisions are
enforced.
Import Safety
AdvaMed believes ensuring the safety and effectiveness of medical
technology is a shared responsibility between government, industry and
users--wherever the product is designed and manufactured. Government
establishes and enforces the laws and regulations intended to provide
patients with medical technology that is as safe as possible and
functions as intended. Manufacturers have the obligation to make
products and establish quality management systems that comply with
these laws and regulations. Both parties have an interest in promoting
public confidence in the medical technologies used in healthcare
delivery.
U.S. Food and Drug Administration (FDA) regulations governing the
sale of medical devices in the U.S. are recognized around the world as
providing U.S. patients high quality medical devices. Any medical
device sold in the U.S.--including all imported medical devices or
devices made with components produced overseas--will have undergone a
review and approval process by the FDA, including inspections of the
manufacturing facilities for higher-risk products. Medical devices also
are subject to FDA's post-market surveillance requirements. While
AdvaMed members are confident in the safety of their own products, the
U.S. Government has much better access to information to assess whether
medical devices being imported into the U.S. meet FDA requirements. We
welcome measures that will ensure consistency in the requirements
applied in practice to domestically-produced and imported medical
devices.
We believe that communication between governments, involving
industry in the process, is very important. AdvaMed has developed good
working relations with key regulatory agencies in many countries. Our
approach with both foreign governments and industry is to seek ways to
improve information on best practices, communication and appropriate
regulatory systems.
Over the years, AdvaMed and its members have conducted--and
continue to conduct--seminars and training programs for government
officials on best regulatory practices. By improving understanding of
international best practices, we believe the safety and effectiveness
of medical devices--along with patient access to those technologies--
will be enhanced world wide.
Information Sharing
Under U.S. regulations, the medical technology industry is required
to provide FDA information to assist in its enforcement of regulatory
requirements. Such information includes pre-market evidence, which
enables FDA to evaluate the safety and effectiveness of a product
before it is sold in the U.S. The industry also provides FDA
considerable post-market information, including adverse event reports
and notice of significant changes in product design or manufacture, and
is subject to ongoing facility inspections.
The U.S. FDA has access to more information on the U.S. medical
technology industry than any other regulatory agency in the world has
on its industry. Some of this information is business sensitive and
confidential. In the right hands, necessary information can help ensure
unsafe products do not reach patients and/or that appropriate and
timely corrective action may be taken by industry and government.
In the wrong hands, this same information can prevent safe products
from improving patients' lives and be used to block market access.
Regulators in other countries who either do not understand, or do not
want to understand, or react inappropriately to, the meaning of FDA's
information can cite it to unfairly deny access for U.S. medical
devices. Many other countries use industrial policy to foster exports
and discourage imports. We ask that U.S. Government officials recognize
these imbalances--regarding the extent of information available, the
understanding of regulatory data, and/or the differences in available
resources--in FDA compared to the rest of the world when determining
information sharing arrangements between governments.
In particular, we make the following recommendations.
FDA should provide information to foreign governments
only to the extent it receives comparable information in return. Since
the task of the Interagency Working Group's activities is to determine
ways to protect Americans from unsafe imports, U.S. negotiators should
focus on defining the information foreign governments are willing to
provide the U.S., and respond accordingly.
FDA should provide foreign authorities safety information
only on the specific medical technology products that are actually sold
in the other country's market. Information on other products, which
might be similar to products sold in another country, could be
misunderstood and/or misused--e.g., as an inappropriate excuse to deny
access.
If information on specific products sold in a foreign
country is shared with foreign authorities, FDA should ensure that the
information is used appropriately for safety reasons, which might
require training for foreign regulators and/or conditions for denying
access to any future data if conditions are not met.
If FDA provides foreign authorities information on a
situation labeled a ``recall'' in the U.S., that term should not be
used with foreign authorities unless a product is being removed from
the U.S. market. No other country uses the term ``recall'' for the
broad range of actions, characterized by FDA as ``recalls.'' While the
Global Harmonization Task Force (GHTF) term ``field safety corrective
action'' would be most appropriate, an alternative would be for FDA to
simply describe the action taken, without labeling the action a
``recall.''
FDA inspection reports should not be shared with foreign
authorities without obtaining a company's approval. Such reports
contain sensitive and confidential information. Many countries'
regulatory systems are still evolving, and their inexperience with FDA
inspections could cause them to over-react. Even if confidential
information is redacted from FDA submissions, a foreign government is
likely to require the U.S. firm to provide all information as a
condition for sales.
Appropriate Regulatory Systems
The GHTF provides excellent guidance documents, with strong
emphasis on quality management systems and international standards, as
the basis on which to develop regulations for medical devices. The
U.S., Europe, Japan, Canada and Australia are founding members of the
GHTF and make use of GHTF guidance documents. Many countries outside of
the GHTF membership are developing their own regulatory systems for
medical devices and tend to rely inappropriately on regulations for
pharmaceuticals and type testing, instead of quality management
systems. The result is that some countries' regulations and actions do
not reflect best international practices and cannot control safety and
effectiveness as well as appropriate medical device regulations based
on a quality management systems approach. In addition, some foreign
regulations often impose more stringent regulatory procedures on
imported products--which can be effectively blocked at the border--than
on domestic products.
FDA should press for a quality system approach as the basis for
medical device regulation and the elimination of type testing,
especially testing that is redundant and unnecessary. Foreign
countries' resources could be better used for developing a modern
regulatory framework than being expended on outdated, costly and
inappropriate procedures. This approach would be consistent with the
Interagency Working Group's recommendation to use a ``video'' instead
of a ``snapshot'' to evaluate imports. Such an approach to assessing
and controlling imports, from design to post-market surveillance
coupled with a risk management philosophy across the product life
cycle, are well-established principles in the medical device sector
(FDA quality systems regulation and international medical device
quality management systems standard ISO 13485). We support their
broader application throughout the supply chain. This approach would
also encourage international regulatory harmonization.
We recommend that U.S. and foreign governments, in cooperation with
U.S. and foreign industry, launch an initiative to assist other
countries interested in improving their regulatory regimes for medical
technology. This initiative could focus on greater reliance on the
quality management systems approach, international standards and
perfecting post-market surveillance systems.
Conclusion
AdvaMed and its members strongly endorse government regulations
that promote the safety and effectiveness of medical technology in the
U.S. and abroad. It is in the best interest of patients, clinicians,
and our industry that only the highest quality of medical technology is
allowed to be placed on the market in any country. We have made
recommendations which we believe will achieve these objectives without
imposing barriers delaying or preventing U.S. medical technology from
entering other countries.
Statement of Airport Duty Free Stores
The International Association of Airport Duty Free Stores is
pleased to submit these comments for the record of your October 4, 2007
joint Subcommittee hearing on Import Safety.
IAADFS represents operators of airport duty free stores. Our
members import a narrow range of products for sale duty-free to
travelers exiting the United States. Strict government regulations
apply to our operations to ensure that only ticketed passengers
traveling to a foreign destination may purchase products in a duty free
store. As a further precaution, items purchased in a duty free store
cannot be carried out of the store by the traveler, but instead must be
delivered directly to the departing aircraft at a point of no return.
As such, the products never enter the stream of U.S. commerce.
As the Committee exercises its jurisdiction over the serious issue
of import product safety, we encourage you to remain aware of its
impact on the import process, including the very unique environment of
airport duty free stores. Legislation should reflect the fact that:
Products sold in a duty-free store never enter U.S.
commerce. The products are imported, held in a highly regulated customs
bonded warehouse that is subject to stringent security standards, and
sold only to passengers leaving the U.S., as described above.
The duty-free industry was subject to rigorous security
and accounting procedures long before the Nation became concerned about
terrorist threats or unsafe products. These procedures were established
initially to protect the revenue of the U.S. Treasury, but now serve to
assure protection against security or safety concerns, as well. The
government recognized the need to facilitate personal purchases by
individual travelers crossing international boundaries. Therefore, the
law creates the framework for U.S. duty-free stores to sell imported
products duty- and tax-free to these individual travelers leaving U.S.
soil. However, in return, virtually every aspect of a duty free store's
operation--from import to export--is subject to the highest regulatory
requirements to make certain these products do not enter U.S. commerce
but are sold for export only.
Products sold in duty fee stores are low-risk products.
They tend to be high-end luxury items. The range of food products is
very narrow and includes items such as expensive chocolates or gourmet
packaged food. The supply chain is also very secure, with CBP
regulating and overseeing each movement within the U.S.
With the volume of imports at an all-time high, it does not make
sense to devote scarce FDA or other agency resources to this highly
regulated niche of low-risk, imported products that never enter the
stream of U.S. commerce. We therefore urge the committee to apply any
new import safety rules to products ``imported for consumption in the
U.S.''
Similarly, any product safety legislation should also provide a
narrow exclusion for products brought back to the U.S. by returning
citizens and U.S. residents under the personal use allowances (Chapter
98 of the Harmonized Tariff System). There would be no purpose served
by subjecting individual Americans bringing back small personal use
quantities, purchased during their travels overseas, to the fees,
rules, restrictions and penalties that may apply to commercial
importers.
Thank you for the opportunity to submit these comments and please
let me know if you require additional information and/or have any
questions.
Statement of American Academy of Pediatrics
The American Academy of Pediatrics (AAP), a non-profit professional
organization of 60,000 primary care pediatricians, pediatric medical
sub-specialists, and pediatric surgical specialists dedicated to the
health, safety, and well-being of infants, children, adolescents, and
young adults, appreciates this opportunity to submit testimony for the
record of this hearing on import safety.
The American Academy of Pediatrics commends the Subcommittees on
Trade and Oversight for this effort to pay long-overdue attention to
the safety of imported products. The AAP supports initiatives to
increase staff and funding for regulatory agencies, give them more
tools to police the marketplace, and require manufacturers and sellers
of products to pursue safety more zealously.
The safety of imported products has special implications for
children's health. In 2006, the United States imported to close $2
trillion worth of goods. A substantial percentage of these imports were
food that was consumed by children and their families and products for
use by or with children. China is the largest producer of imported
children's toys, responsible for manufacturing 86 percent of all toys
sold in the United States.
In recent months, public attention has focused on the safety of
children's products after a wave of recalls of popular children's toys
by the Consumer Product Safety Commission (CPSC). Recalls have been
issued for toys that violated standards for lead paint as well as those
that posed choking, strangulation, fall, and entrapment hazards. It is
vitally important that the U.S. set and enforce strong standards to
ensure parents that the products used by and with their children are
safe. Manufacturers should be held accountable for ensuring that their
product designs are sound and do not present a foreseeable safety
hazard. In addition, the government should set strict standards for
acceptable lead content in children's products.
Lead is Ubiquitous in Our Environment
Lead is a soft, heavy and malleable metal that occurs naturally in
trace amounts throughout the environment. Due to its abundance and easy
workability, it has been used for thousands of years in plumbing,
production of glass and crystal, and manufacture of ammunition.\1\ Its
toxicity was recognized by the Romans\2\ and documented during the
twentieth century, as its increasingly widespread use led to
unprecedented levels of occupational and environmental lead
poisoning.\3\ By 1970, science had demonstrated conclusively that lead
could cause both acute poisoning as well as a wide range of long-term
human health consequences.3,4 Since then, hundreds of
studies have shown that the body has no use for lead, and that a
``normal'' blood lead level is zero. Because of its widespread use,
lead has been concentrated in the environment where it poses a serious
threat to children's health. Furthermore, because it cannot be
identified easily, even when present in high amounts in paint, dust, or
dirt, children can be exposed in their homes and schools and at play
without our knowledge. It is an ``invisible'' poison.
Low Levels of Lead Can Cause Serious Effects
Damage done by small amounts of lead may be hard to measure and
even harder to understand. Most children who accumulate lead in their
body do not have any physical symptoms, but low lead levels cause a
wide array of negative effects, including cognitive, motor, behavioral,
and physical harm.\5\
There is no ``safe'' level of lead exposure. The developing embryo,
fetus, and child grow and change rapidly. If, during this period of
change, the fetus or child is exposed to a poison of some kind,
development can be impacted negatively. These ``critical windows of
exposure'' are specific periods of development during which the embryo
or fetus is undergoing some process (such as the development of arms
and legs between days 22 and 36 of pregnancy, when thalidomide damages
their development.6,7) There are many other examples of this
effect, including tobacco smoke and behavioral effects, and alcohol and
fetal alcohol syndrome. The critical period associated with harm from
lead poisoning is brain and nervous system development, which begins in
early pregnancy and continues until at least age 3 years.\8\
The vulnerability of children to lead poisoning during development
of their brain and nervous system has been amply demonstrated, and the
literature is very consistent. On average, children whose blood lead
levels (BLLs) rise from 10 to 20 mcg/dL lose two to three IQ points.
More recent studies have shown an even greater impact on IQ of BLLs
under 10 mcg/dL. Key studies reported a loss of 4 to 7 IQ points in
children whose lead levels rose from 1 mcg/dL to 10 mcg/
dL.9,10 These studies suggest that ``low'' levels of
exposure--meaning BLLs less than 10 mcg/dL--cause proportionately
greater harm than higher levels. The effects of lead on health do not
stop once the child reaches age 6 years. A recent study found that in a
group of 7-year old children exposed to lead before the age of 3 years,
IQ was more closely related to blood lead at age 7 years than past
blood lead at age 5 or peak blood lead at approximately age 2
years.\11\
Another important lasting effect of lead exposure is on behavior,
with higher rates of behavioral problems reported in teens and adults
exposed to lead during childhood. Children with elevated lead are more
likely to have problems with attention deficit, reading disabilities,
and to fail to graduate from high school.\12\ Investigators have
identified associations between lead exposure and increased aggression,
commission of crime and antisocial or delinquent
behaviors.13-16 Studies have suggested that several nations
which began reducing lead exposure aggressively in the 1970s
experienced corresponding decreases in crime rates two to three decades
later.\16\ Other effects include abnormal balance, poor eye-hand
coordination, longer reaction times, and sleep
disturbances.12,17,18
The loss of a few IQ points or a small increase in the proportion
of children with behavioral problems in the population of U.S. children
has marked impacts on educational needs and future potential.\19\ Since
lead exposure is a population-wide risk, even relatively low levels of
exposure can affect large numbers of children. This means that more
children need special education, there are fewer gifted children, and
over time, the average IQ of the entire population falls.
Lead Poses a Serious Threat Hazard to Children At Every Level of
Exposure and Every Stage of Development
Lead is easily absorbed by ingestion or inhalation. The most common
route of exposure of children is through ingestion, usually by putting
hands and other objects in their mouth. Both hand-to-mouth exploration
and playing on floors are typical behaviors for children, especially
younger children. Studies using videos to record oral behaviors of
young children report hand or object in mouth activities 20 or more
times per hour.20,21 If the dirt on their hands or the dust
on the floor contains lead, every one of those activities delivers a
dose of lead.
Another significant difference between children and adults is in
the rate of their metabolisms. Children have significantly faster
metabolisms, which means that they breathe faster and ingest
proportionately more food and water.\22\ This difference means that in
similar environments, children are exposed to a greater extent to
contaminants than adults. Since children absorb 5 to 50 percent of any
lead they ingest (compared to adults, who absorb 10-15 percent),\23\
they are at high risk of lead poisoning every time they are exposed.
Once lead enters the body it remains there for years. Lead is
similar to calcium from the elemental perspective. This means that our
bodies ``see'' lead as calcium, absorb it into blood and then store it
in bone. These stores of lead can be released years later, when bone
changes occur or demands on calcium stores are made.\24\ Another
consequence of storing lead in bone is that exposures separated by
months or years have an additive effect on the body's burden of lead
and can exert effects over decades. Acquisition of lead in the body
even in small amounts (i.e., amounts that result in BLLs less than 10
mcg/dL) contribute to this accumulation of lead. This means that
commonly encountered blood lead concentrations have lasting negative
effects.
Another consequence of this accumulation of lead in bone is the
exposure of the fetus to lead by the mothers. Women exposed to lead
during childhood may have significant stores of lead in their bones. If
they do not consume adequate calcium during pregnancy, their bones
release calcium as the fetus grows. As the calcium is released, lead is
released as well. This lead can be transferred to the fetus--exposing
the fetus' developing brain and nervous system at a critical time.
Fetal exposure from this route has been demonstrated to cause
measurable decreases in IQ.\25\
Sources of Children's Exposure to Lead
The most common source of lead exposure today is lead paint, found
in older housing stock. As paint wears off, it contaminates the dust
that clings to surfaces, toys and the fingers of children. Other
sources of lead exposure include contaminated soil, traditional or folk
medicines, and certain types of dishes. In recent years, however,
parents have found a new source of anxiety regarding lead exposure:
children's toys and other products, particularly those imported from
China.
These concerns are justified. Since July 2006, the CPSC has issued
at least 11 recalls affecting more than 6.7 million units of children's
toy jewelry due to excessive lead content. Since 1998, CPSC has issued
at least 29 recalls involving 157,962,000 pieces of toy jewelry due to
high lead levels. Other products recalled during that time due to lead
contamination include game pieces, candles, sidewalk chalk, and art
kits. Consumers are acutely aware of recent recalls of popular toys
found to contain lead paint, including Thomas the Tank Engine, Mattel's
Barbie, and Fisher-Price's Dora the Explorer toys. The risk of harm to
children from these toys is real: in 2006, a 4-year-old Minnesota boy
died after ingesting a small Reebok shoe charm that was later found to
be 99.1 percent lead.\26\ The charm he ingested dissolved in his
stomach, releasing the lead into his bloodstream.
Lead Must Be Removed from Toys and Other Children's Products
The American Academy of Pediatrics has consistently urged the
Consumer Product Safety Commission (CPSC), the Environmental Protection
Agency (EPA), and other agencies to take aggressive, proactive steps to
minimize children's exposure to lead. The addition of lead to jewelry
or toys is not in any way central or even necessary to the function or
purpose of the product. For example, manufacturers add lead to jewelry
to give it more weight or heft, rather than using a more expensive but
safer metal. None of these factors represent a compelling rationale for
including a poisonous substance in a product specifically designed for
use by children.
The range of products covered by a ban on lead content must also be
considered carefully. ``Children's product'' must be defined broadly
enough to cover the full range of items capable of causing a serious
hazards--not just toys or ``toy'' jewelry but also durable products
such as furniture (cribs, strollers, high chairs, etc.) and products
meant for the care of children (bath seats, gates, etc.). One of the
first pediatric deaths attributed to lead paint was a child who chewed
on the railing of his crib--in 1913.\4\
Finally, legislation should cover products meant or designed for
use by or with children at least up through the age of 12. Children are
susceptible to neurological damage from lead exposure throughout the
development of their brain and nervous system. Their long ``shelf
life,'' or the period of time over which they can be exposed to and
accumulate lead in their bodies, means that every exposure should be
eliminated or minimized to prevent future harms. Finally, toys meant
for older children often find their way into the hands of younger
siblings and other small children, posing a hazard to these children
outside the object's target audience.
Federal Lead Standards
Federal agencies use a variety of standards for unacceptable lead
content. This issue is complicated by the fact that lead uptake varies
depending upon the route of exposure (ingestion, inhalation, skin
contact, etc.) In considering existing guidelines, it is critical to
bear in mind that many were set before research demonstrated the
harmful effects of lead at low levels. There is no known safe level of
lead exposure; as a result, exposure to lead below these levels should
not be considered ``safe.''
In 1978, the Consumer Product Safety Commission banned
the manufacture of paint containing more than 0.06 percent lead by
weight on interior and exterior residential surfaces, toys, and
furniture.
Based on that standard for lead paint, the CPSC's current
voluntary standard prohibits toy jewelry to contain more than 0.06
percent lead by weight. The standard further requires manufacturers to
test for the ``accessibility'' of lead, although surface accessibility
may be irrelevant if an item is small enough to be ingested.
The EPA requires water provided by public utilities to
contain no more than 15 parts per billion of lead. The 1986 Safe
Drinking Water Act Amendments banned the use of lead in public drinking
water distribution systems and limited the lead content of brass used
for plumbing to 8 percent.
The EPA set guidelines for lead contamination of dust,
limiting levels called ``safe'' to below 40 mcg/ft \2\ for floors.\27\
It is important to note that this is not a health-based standard; an
estimated 20 percent of children exposed to floor dust lead levels at
40 mcg/ft \2\ will have a blood lead level above 10 mcg/dL.\28\
In response to reports of lead contamination in candies
likely to be consumed frequently by small children, the Food and Drug
Administration (FDA) set a maximum lead level of 0.1 parts per million
(ppm). FDA has set different levels for other products; for example,
dairy product solids may contain lead at no more than 0.5 ppm.\29\
The FDA recommends a limit on children's lead intake in
food to no more than 6 mcg/day. It is important to note that this is
not a health-based standard; this limit is roughly equivalent to the
amount of lead that would be expected to lower IQ by 1 point.
FDA regulates lead content in cosmetics; for example, the
colorant manganese violet may contain lead at no more than 20 ppm.\30\
Airborne lead is regulated by EPA as a ``criteria
pollutant'' under the Clean Air Act. The National Ambient Air Quality
Standard for lead is 1.5 mcg/m\3\, maximum arithmetic mean averaged
over a calendar quarter.
Both the National Institute for Occupational Safety and
Health and the Occupational Safety and Health Administration set
permissible limits for lead exposure in the workplace, but these
guidelines are designed for adults and not appropriate for children.
Recommendations
To protect the health of our Nation's children, the CPSC must be
given the tools it needs to fulfill its mission. In particular,
nonessential uses of lead, especially in products to which children may
be exposed, must be prohibited. The American Academy of Pediatrics
recommends the following:
The CPSC should require all products intended for use by
or in connection with children to contain no more than trace amounts of
lead.
The Academy recommends defining a ``trace'' amount of
lead as no more than 40 ppm, which is the upper range of lead in
uncontaminated soil.\31\ This standard would recognize that
contamination with minute amounts of lead in the environment may occur
but can be minimized through good manufacturing practices.
``Children's product'' should be defined in such a way as
to ensure it will cover the wide range of products used by or for
children. This standard should cover toys intended for use by or with
children under the age of 12 years.
The limit on lead content must apply to all components of
the item or jewelry or other small parts that could be swallowed, not
just the surface covering.
Legislation or regulations should limit the overall lead
content of an item, rather than only limiting lead content of its
components. A single product may contain numerous components that could
cumulatively contain a dangerous level of lead.
The CPSC must be funded adequately. The President
requested a budget of $63.2 million for CPSC in Fiscal Year 2008, which
would require the agency to cut an additional 19 employees. This budget
is insufficient to even allow the agency to continue current programs,
much less expand its efforts. At its founding, the CPSC budget was $39
million. If the budget had kept pace with inflation, it would be $138.2
million today, more than double its requested allocation.
An appropriately qualified CPSC chair must be nominated
and approved in a timely fashion. The CPSC has been without a voting
quorum of commissioners since January 2007, meaning it cannot take many
regulatory, enforcement and other actions. The President's recent
nominee to chair the commission withdrew from consideration after a
public outcry regarding his qualifications.
The authority of the agency to issue mandatory recalls
and provide full information to consumers must be strengthened.
Conclusion
Our government can and must do more to ensure the safety of
imported products, particularly those intended for use by or with
children. A strong standard for lead content must also be set, since
there is no known ``safe'' level of lead for children.32,33
No study has determined a blood lead level that does not impair child
cognition. Since any measurable lead level causes lasting harm,
prevention of exposure is the only treatment.\34\ Lead exposure is an
important, unnecessary, and preventable poisoning.
The American Academy of Pediatrics appreciates this opportunity to
submit testimony for the record of this hearing on import safety. If
the AAP may be of further assistance, please contact our Washington,
D.C. office.
References
1. Chemistry: WebElements Periodic Table. http://
www.webelements.com/webelements/elements/text/Pb/key.html. Accessed
March 31, 2004.
2. Lead Poisoning and Rome. http://itsa.ucsf.edu/:snlrc/
encyclopedia_romana/wine/leadpoisoning.html. Accessed March 31.
3. Markowitz G, Rosner D. ``Cater to the children'': the role of
the lead industry in a public health tragedy, 1900-1955. Am J Public
Health. 2000;90(1):36-46.
4. Warren C. Brush With Death: A Social History of Lead Poisoning.
Baltimore, MD: Johns Hopkins University Press; 2000.
5. Bellinger D. Lead. Pediatrics. 2004;113(4 (Supplement)):1016-
1022.
6. Brent R. Environmental causes of human congenital malformations:
the pediatrician's role in dealing with these complex clinical problems
caused by a multiplicity of environmental and genetic factors.
Pediatrics. 2004;113(4 (Supplement)):957-968.
7. Sadler TW. Langman's Medical Embryology. 6th ed. Baltimore, MD:
Williams & Wilkins; 1990.
8. Mendola P, Selevan SG, Gutter S, Rice D. Environmental factors
associated with a spectrum of neurodevelopmental deficits. Ment Retard
Dev Disabil Res Rev. 2002;8(3):188-197.
9. Canfield RL, Henderson CR, Jr., Cory-Slechta DA, Cox C, Jusko
TA, Lanphear BP. Intellectual impairment in children with blood lead
concentrations below 10 microg per deciliter. N Engl J Med.
2003;348(16):1517-1526.
10. Lanphear BP, Hornung R, Khoury J, et al. Low-level
environmental lead exposure and children's intellectual function: an
international pooled analysis. Environ Health Perspect. Jul
2005;113(7):894-899.
11. Chen A, Dietrich KN, Ware JH, Radcliffe J, Rogan WJ. IQ and
blood lead from 2 to 7 years of age: are the effects in older children
the residual of high blood lead concentrations in 2-year-olds? Environ
Health Perspect. 2005;113(5):597-601.
12. Centers for Disease Control and Prevention. Managing Elevated
Blood Lead Levels Among Young Children: Recommendations from the
Advisory Committee on Childhood Lead Poisoning Prevention. Atlanta, GA:
Centers for Disease Control and Prevention.; 2002.
13. Dietrich KN, Ris MD, Succop PA, Berger OG, Bornschein RL. Early
exposure to lead and juvenile delinquency. Neurotoxicol Teratol. Nov-
Dec 2001;23(6):511-518.
14. Ris MD, Dietrich KN, Succop PA, Berger OG, Bornschein RL. Early
exposure to lead and neuropsychological outcome in adolescence. J Int
Neuropsychol Soc. Feb 2004:261-270.
15. Burns JM, Baghurst PA, Sawyer MG, McMichael AJ, Tong SL.
Lifetime low-level exposure to environmental lead and children's
emotional and behavioral development at ages 11-13 years. The Port
Pirie Cohort Study. Am J Epidemiol. Apr 15 1999;149(8):740-749.
16. Nevin R. Understanding international crime trends: the legacy
of preschool lead exposure. Environ Res. 2007;104(3):315-336.
17. Bhattacharya A, Shukla R, Dietrich KN, Bornschein RL. Effect of
early lead exposure on the maturation of children's postural balance: a
longitudinal study. Neurotoxicol Teratol. 2006;28(3):376-385.
18. Chiodo LM, Covington C, Sokol RJ, et al. Blood lead levels and
specific attention effects in young children. Neurotoxicol Teratol. Apr
21 2007.
19. Bellinger DC. What is an adverse effect? A possible resolution
of clinical and epidemiological perspectives on neurobehavioral
toxicity. Environ Res. 2004;95(3):394-405.
20. Reed KJ, Jimenez M, Freeman NC, Lioy PJ. Quantification of
children's hand and mouthing activities through a videotaping
methodology. J Expo Anal Environ Epidemiol. 1999;9(5):513-520.
21. Ko S, Schaefer PD, Vicario CM, Binns HJ. Relationships of video
assessments of touching and mouthing behaviors during outdoor play in
urban residential yards to parental perceptions of child behaviors and
blood lead levels. J Expo Sci Environ Epidemiol. 2007;17(1):47-57.
22. Plunkett LM TD, Rodricks JV,. Differences between adults and
children affecting exposure assessment. In: Guzelian PS HC, Olin SS,,
ed. Similarities and Differences Between Children and Adults:
Implications for Risk Assessment. Washington, DC: ILSI Press; 1992:79-
94.
23. United State Environmental Protection Agency. Review of the
National Ambient Air Quality Standards for Lead: Exposure Analysis
Methodology and Validation. Washington, DC: Air Quality Management
Division, Office of Air Quality Planning and Standards, U.S.
Environmental Protection Agency; 1989.
24. O'Flaherty EJ. A physiologically based kinetic model for lead
in children and adults. Environ Health Perspect. 1998;106 Suppl 6:1495-
1503.
25. Schnaas L, Rothenberg SJ, Flores MF, et al. Reduced
intellectual development in children with prenatal lead exposure.
Environ Health Perspect. 2006;114(5):791-797.
26. Centers for Disease Control and Prevention. Death of a child
after ingestion of a metallic charm--Minnesota, 2006. MMWR.
2006;55(12):340-341.
27. Federal Register. Part III, Environmental Protection Agency.
Lead; Identification of Dangerous Levels of Lead: Final Rule.
2001;66:1206-1240.
28. Lanphear BP, Weitzman M, Winter NL, et al. Lead-contaminated
house dust and urban children's blood lead levels. Am J Public Health.
1996;86(10):1416-1421.
29. Food and Drug Administration. GRAS affirmation petition GRP
1G0371. http://www.cfsan.fda.gov/:rdb/opa-g037.html.
30. U.S. Food and Drug Administration. 21CFR73.2775. http://
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?fr=73.2775.
31. Friedland A, Johnson A. Lead distribution and fluxes in a high-
elevation forest in northern Vermont. J Environ Qual. 1985;14:332-336.
32. American Academy of Pediatrics Committee on Environmental
Health. Lead exposure in children: prevention, detection, and
management. Pediatrics. 2005;116(4):1036-1046.
33. Centers for Disease Control and Prevention. Preventing Lead
Poisoning in Young Children. Atlanta: CDC; 2005.
34. Centers for Disease Control and Prevention. Preventing Lead
Exposure in Young Children: A Housing-Based Approach to Primary
Prevention of Lead Poisoning. Atlanta: CDC; 2004.
Statement of AmeriSci Group, Midlothian, Virginia
Chairmen and Levin and Lewis, and Members of the Subcommittees, I
am SiuMing Tomi Hong, Chief Executive Officer of the AmeriSci Group. I
appreciate the opportunity to present this statement on the critically
important issue of imported food and consumer product safety.
The AmeriSci Group is a U.S. company with over 20 years experience
in analytical testing of product, food and environmental safety as well
as crisis management. We routinely provide unbiased scientific data to
risk managers in both government and industry responsible for making
decisions that have a direct and immediate impact on public health and
safety, as well as the overall well being of American citizens.
Accredited by A2LA, AIHA, NVLAP/NIST, NELAC and several state agencies,
we believe we are well positioned to provide an objective evaluation
and to propose solutions to the current issues bearing on the safety of
imported food and consumer products.
As concerned scientists and citizens of this great Nation, we at
AmeriSci recognize that the current import safety climate, highlighted
most recently by concern over the safety of products from China, has
created an untenable level of uncertainty--uncertainty in the eyes of
the consumer, of course, but also in the eyes of manufacturers and
importers of food and other consumer goods. We also recognize that, if
left unresolved, the current climate could erode the trust of consumers
in the safety of all goods, not just those imported from China, as well
as in the government's ability to protect its citizens.
Loss of consumer confidence in product safety has the potential to
negatively affect domestic consumption and the economic well-being of
our Nation, this fact highlights the synergy--or balance--between
industry and commerce, science and government in providing a stable
commercial environment where consumers have access to goods they can
trust. This delicate balance, which has been able to deliver safe goods
to American consumers for the greater part of the last century, must be
maintained in today's global market place. We must recognize and
address the new risks associated with the expansion of supply chains
across geographic, cultural and national borders. Solutions for
restoring this balance must be the product of good science, effective
policymaking and a deep commitment to involve all stakeholders in the
solution.
In seeking a workable solution, we generally support the principles
and framework outlined in the September 10, 2007 Report to the
President of the President's Interagency Working Group on Import
Safety, in response to Executive Order 13439. In particular, we applaud
the Working Group's foresight in proposing that the solution focus on
``risks over the life cycle of'' imported goods. Congress also has a
significant role to play both by ensuring that these important issues
are addressed in a public forum and by passing legislation that
corrects gaps in the current law without imposing unnecessary costs and
burdens on importers and consumers which could stifle creative private
sector initiatives.
In seeking a viable and sustainable solution to the perceived
``inbalance'' in the present import safety arena, AmeriSci, like the
Working Group, believes that the solution will come from establishing
processes to assess risks at the source of the problem, not at the end
of the supply chain--namely, a preventive approach. We must assess all
potential risks at each tier of the supply chain and focus our efforts
on first eliminating the most egregious risks. The end goal must be to
create the necessary mechanisms that will allow risk assessment and
risk management professionals to actively engage with manufacturers and
importers in assessing and reducing risks along their supply chains.
At the same time, we believe there are four important areas that
have been overlooked and must be addressed as we develop the tools to
create such mechanisms:
1. Lack of Clear Standards. There is a lack of clarity of
standards in regard to health risks and testing methodologies among
U.S.-based companies and overseas manufacturing contractors and
subcontractors. For example, during his recent visit to Washington,
Vice Minister Wei from China's General Administration for Quality
Supervision, Inspection and Quarantine (AQSIQ) cited a situation where
AQSIQ was measuring lead in the surface paint on toys when, in fact,
the U.S. standard calls for measurement of the total lead content in
the finished product. This difference or breakdown in technical
information sharing continues to create challenges in the import safety
process.
2. Failure to Update and Communicate Standards. Many current
product safety standards were established decades ago, and have not
been updated to reflect current risk-based science and manufacturing
practices. For those standards that have been updated, the efficiency
of government communication of these standards to manufacturers and
exporters has been less than stellar, with significant lag times in the
conveyance of information through commercial channels and delays in
implementation of standards by producers. In addition, as new compounds
of toxicological concern are added to the product safety target lists,
the relevant information--such as compliance levels, testing methods
and so on--has, in some instances, never even been received by the
overseas contractors and subcontractors, leaving them to rely on an
outdated standard.
3. Understanding the Causes of Contamination. It is crucial that
we understand the underlying cause for the introduction of harmful
substances into consumer products. In our view, there are two principal
pathways for product contamination. The vast majority of cases result
from poorly defined and poorly communicated safety guidelines. This so-
called passive contaminant introduction, or PCI, into the supply chain
can be addressed through education of all stakeholders, as well as
through standards that address the most critical threats to health and
safety, and not just those which rise to the level of widespread media
coverage.
The second area of concern is active contaminant introduction
(ACI). We must recognize that unscrupulous producers or distributors
can exist along the supply chain, as demonstrated by the apparent
intentional introduction of melamine in the recent incident of pet food
contamination. In the highly competitive market of outsourcing, pricing
of goods has become the major source of competition. There are those
that will use substandard materials or even dispose of hazardous
materials in an effort to increase profit margins. This threat must not
be ignored. It has happened and it will happen again. Only systematic
testing at the source of manufacture as well as at high risk links
along the supply chain, will enable us to identify this threat before
it enters international channels of trade.
4. Contaminant Concentration. Stakeholders must review
concentration levels and develop effective compound target lists. For
example, the current U.S. standard for Lead in Toys, 600 mg/kg,
represents a value that is exceedingly high from a toxicological and
environmental standpoint. If, for example, another material such as
construction debris were determined to have a similar level of lead,
State and Federal hazardous waste disposal guidelines would mandate
additional studies, likely resulting in the material being declared
``hazardous,'' and too toxic for disposal in a landfill. In essence,
the current regulations tell American consumers that a toy containing
lead is too toxic to dispose in a landfill, but it is okay to give that
same toy to our children.
Additional concerns come about from the lack of broad-spectrum
heavy metals testing in consumer products. Although a significant
amount of media attention has driven numerous proposals for updating
Lead in Toys standards, far more toxic elements have received little to
no attention or review. For example, cadmium--an element having
toxicity approximately 5 times that of lead for some endpoints, is
occasionally found in colored plastics and rubber materials at levels
in excess of 1,000 mg/kg. Consequently, it is necessary to avoid the
very myopic focus solely on lead as the only hazard associated with
pigments/materials used in consumer products. Legislation may be
required to ensure that solutions are in place to correct these
deficiencies. Finally, I would like to discuss how so-called ``third
parties'' can contribute to successful resolution of the current
situation. While there has been much discussion of applying a private
sector 3rd party solution, it is essential that a distinction be made
between 3rd Party Testing versus 3rd Party Certification.
A 3rd Party Certifier provides the function of quality systems
oversight in the form of accreditation of a business operation,
ensuring that the performance is in conformance with an industry-
specific and/or international standard (e.g., ISO 17025, ISO 9002).
3rd Party Testing is performed by a 3rd Party Certifier-approved
testing facility, capable of generating an industry-recognized testing
report of compliance and conformance with manufacturing design
specifications and healthy & safety guidelines.
Although hundreds of domestic and foreign 3rd Party Testing
facilities are available for the ongoing evaluation and validation of a
variety of food and consumer products, there is currently no U.S.
agency or universally accepted not-for-profit organization providing
3rd Party Certification services for the toy industry.
AmeriSci already has the framework for a not-for-profit private
sector 3rd Party Certifying body in place. We will model the operation
of this accrediting body after other successful industry-specific
agencies such as the American Industrial Hygiene Association (AIHA) and
UL Corp. The added benefit of such an accrediting agency will be the
ongoing training and sharing of relevant procedural and compliance
standards information. This accrediting body will also provide
consulting and training services, which will prove especially helpful
for the small and mid-size manufacturers lacking the internal resources
to develop their own rigorous quality systems programs.
Through implementation of the improved communication and
coordination by our certification program, AmeriSci will be able to
coordinate improved import safety efforts through rigorous product
testing programs, development of standards & distribution of
information mutually agreed upon by CPSC and the product industry,
similar to FDA/USDA and EPA/OSHA models.
As an extension of our certification program for consumer products,
AmeriSci will facilitate the ongoing development of programs geared
toward restoring consumer confidence in the marketplace.
One of the extensions of the AmeriSci program associated with
consumer product safety will include the development of a ``Consumer
Product Safety Data Sheet'' (CPSDS). Drawing it's framework from
existing CPSC references and EPA's mandated Material Safety Data Sheets
(MSDS), this labeling program will provide a UPC barcode-specific
online database for all consumer products. This CPSDS database will be
inclusive of relevant product information and material specifications,
health and safety hazards, compliance certifications, recall
information, point of origin, etc. By allowing this information to be
freely available online, the end user will feel a greater sense of
awareness and accessibility to information about the products they
purchase. An addition critical benefit of this database is its ability
to maintain the confidential identity of sub-manufacturers in the
supply chain, allowing for traceability and rapid determination of root
causes in the event of product quality failures and recalls. In
summary, the benefits from implementation of the AmeriSci certification
programs are:
3rd Party Accreditation of manufacturers and producers
focusing at the production level
Rapid dissemination of relevant standards and compliance
information
3rd Party on-site quality assessment, sampling and
subsequent testing of products
Supply chain evaluation and monitoring
Consumer Product Safety Data Sheet generation,
cataloguing and distribution
The AmeriSci Group thanks the Subcommittees for their leadership
and commitment in the efforts of restoring consumer confidence and
improving imported product safety. You have our commitment to continue
to develop pathways and processes for increased consumer confidence in
the safety of imported products and goods.
Thank you for your consideration of our views.
Statement of Catfish Farmers of America, Indianola, Mississippi
Chairmen Levin and Lewis and Members of the Committee, thank you
for this opportunity to submit testimony to the Ways and Means
Subcommittees on Trade and Oversight. As a catfish farmer from Yazoo
City, Mississippi and President of the Catfish Farmers of America, I am
pleased to be able to provide a unique perspective on the safety of
seafood imports from Asia, specifically China and Viet Nam.
Catfish Farmers of America was established in 1968 to represent the
U.S. Farm-Raised Catfish industry, which is now the largest aquaculture
industry in the Nation. Based in Indianola, Miss., Catfish Farmers of
America represents catfish farmers, processors, feed mills, research
and other entities involved in the industry. The states of Mississippi,
Alabama, Arkansas and Louisiana account for 95 percent of commercial
catfish production in the United States. CFA has over 800 members,
located in more than 20 states. The U.S. catfish industry is a critical
component of the agricultural economy in many states and employs
thousands of workers--including family farmers--in a region that lacks
employment opportunities. This vertically integrated industry processed
well-over 600 million pounds of fish annually prior to the onslaught of
Asian imports. With the multiplier effects as provided by nationally
respected economists, the total economic value of our industry was
close to $3 billion annually.
The domestic farm-raised catfish industry is very transparent. By
that I mean U.S. farm-raised catfish which are raised for consumer
consumption can be traced throughout the production and marketing
chain. The U.S. catfish industry has employed rigorous protocols to
assure that any particular lot of catfish can be traced from the
consumer's plate all the way back to the production pond of origin and
every step along the way. The ponds are highly maintained and monitored
with only limited use of approved treatment regimes. The product that
we produce is antibiotic-free, safe and healthy.
The American people have grown to trust U.S. Farm-Raised Catfish,
and made it a part of their ``healthy diet''. Catfish is America's
sixth most popular seafood and seventy percent of this product is
consumed in restaurants. Furthermore, U.S. Catfish is the number one
aquaculture, or farmed fish in our country.
In recent years, the U.S. catfish industry has been seriously
threatened by imported frozen fish fillets from Asia. This problem
began with Vietnamese exporters flooding the market with unfairly
priced products falsely labeled as catfish. Our industry was so
seriously damaged by these trade practices, that in 2003, the U.S.
Department of Commerce and the International Trade Commission issued an
anti-dumping order against Vietnam.
However, even with tariffs in place, Vietnam continues to expand
its exports to the United States. China has now become a major exporter
of catfish. Beginning in 2004, China began to export limited quantities
of catfish to the United States, but in late 2006, Chinese export
volume surged dramatically. By the end of 2006 China had sent 14
million pounds of frozen fillets of catfish and catfish-like species to
the United States.
Catfish imports have increased by 600 percent over five years and
in the last year alone, there has been a 304 percent increase from
China. This import surge from China has continued into 2007 and by the
end of May this year, importers had brought into the U.S. market over
14.3 million pounds of Chinese catfish and like species, more than the
record volume they had imported in all of 2006. By the end of May,
Chinese imports had captured 18 percent of the market (up from only 4
percent for the same period in 2006, and only 2 percent for all of
2005).
The Chinese have made inroads by pricing their fish well below the
price of U.S. fillets and by employing banned antibiotics to sustain
their product artificially. On average, in 2006 Chinese frozen fillets
of catfish were brought into the U.S. market at prices that were about
33 percent below the price of domestically produced fillets. In 2007,
that differential has increased to over 39 percent. This price
differential is the result of not only the very low wage rates in
China, but also because the Chinese government has targeted aquaculture
as a growth sector. These factors, coupled with currency valuation
practices that are beneficial to exporters, along with China's lack of
enforcement of health and safety standards, has created an extremely
difficult situation for our industry.
As it has been widely reported, the Food and Drug Administration
(FDA) currently inspects less than 1 percent of all imports. As the
representative for the industry, I respectfully suggest the FDA will
never be capable of fully assuring the safety of imported catfish. By
its own admission, the FDA has repeatedly claimed that no amount of
appropriations can ever assure 100 percent inspection of imports. While
we commend the FDA for its issuance of the recent import alert on
seafood from China, that alert has been examined by other Committees in
the U.S. House of Representatives and U.S. Senate and has been found to
be inadequate in protecting the consumer. However, many states are
eager to take on the responsibility of inspecting imported catfish. CFA
believes a pilot program between state regulatory bodies and the FDA
allowing for state inspection of catfish would better protect the
consumer, while allowing for further examination of best practices at
the FDA by the Congress.
We believe that FDA should also work more closely with those
agencies that do monitor the ports of entry into this country. FDA's
own testimony shows that with over 365 ports of entry, the FDA does not
have the resources to be present at every point of entry, but Customs
and Boarder Protection (CBP) maintains a presence at those ports. CBP
has the resources and the database to help the FDA track shipments and
importers. In fact, the USDA works closely with CBP and its import
database on meat, poultry and egg shipments entering the United States,
while the FDA does not have a similar relationship. Coordination of FDA
and CBP will be a better use of FDA's limited resources while improving
consumer safety.
As has been said many times over the past few months, ``the U.S.
cannot inspect its way out'' of the food safety situation we are
currently facing. As an industry, we could not agree more. Despite the
efforts of domestic distributors to work with seafood exporting nations
such as Vietnam, these seafood exporting countries continue to use
unsafe and often dangerous farming practices when it comes to producing
catfish. Repeatedly, traces of antibiotics and carcinogens are found on
those shipments of catfish that the FDA is able to detain for
inspection. In fact, Japan and the EU continue to raise concerns about
the use of banned antibiotics and malachite green in Vietnamese seafood
despite the assurances from Vietnam and domestic distributors that such
substances are no longer being used in their seafood production. We
respectfully ask that Congress look to the import safety regimes of
other nations, such as the EU and Japan. In every instance, those
regimes demand that imported food meet equivalent safety standards to
those required of the domestic industry. Even our own USDA inspection
arm, the Food Safety and Inspection Service (FSIS) demands verification
that exporting countries' regulatory systems for meat, poultry and egg
products are equivalent to that of the U.S. and that products entering
the U.S. are safe and wholesome, yet the FDA does not require importing
countries of all other food products to meet a U.S. food safety
equivalent. We believe the FDA should work with FSIS to replicate their
import enforcement regimes at the FDA.
Consumer confidence in imported catfish will also increase with a
requirement of traceability. By that I mean tracing the product back to
its production pond of origin as we as domestic producers are able to
do. This will allow for greater control over the product and
elimination of those producers in the import market who are subjecting
the American people to unsafe catfish.
Furthermore, the American consumer deserves Country of Origin
Labeling in restaurants. As you well know, Federal law requires that
seafood sold in grocery stores be labeled by its country of origin, yet
there is no corresponding requirement for fish served in restaurants.
Applying this law to restaurants will better allow the consumer to make
educated choices about the foods they are consuming. It is by no means
a cure-all, but a recent poll sanctioned by the Catfish Institute
indicated that 96 percent of consumers want to know the origin of the
catfish that they consume in restaurants. Other national polls have
also made it resoundingly clear that U.S. consumers are demanding the
right to make informed decisions that the food they order is safe to
eat. We are not saying that fairly traded catfish should not be
imported, but that it needs to be raised in a manner which ensures a
safe product that is clearly labeled so that the consumer knows what
they are purchasing.
Chairmen Levin and Lewis and Members of the Committee, I thank you
for this opportunity to submit written testimony to your Subcommittees.
In this time of heightened food safety concerns, we ask that importers
of catfish play by the same rules that domestic producers must play by
in order to protect our industry and the American consumer. This can
only be accomplished with the proper support from Congress. I thank you
for your leadership on this issue.
Statement of Underwriters Laboratories
Underwriters Laboratories Inc. (UL) is pleased to submit testimony
for consideration by the Subcommittees on Oversight and Trade of the
full Committee on Ways and Means. This statement on import safety
issues addresses the important role government authorities, including
U.S. Customs and Border Protection (CBP) and Immigration and Customs
Enforcement (ICE), play in identifying dangerous and noncompliant
products at U.S. borders, seizing products, and bringing perpetrators
to justice. UL has worked closely with CBP and ICE for more than a
decade to identify and seize products bearing the UL Mark and also
prosecute offenders to the fullest extent of the law; our experiences
working to seize and destroy counterfeit products have shaped the
recommendations found in this testimony. UL is pleased to see increased
attention being given to product safety in the United States, and
believes that U.S. government support in this area will help focus
attention on identifying root causes of safety hazards recently
associated with certain imports, in addition to crafting proper
solutions. The remarks below highlight current product safety
challenges and their interaction with standards development and
certification issues. It is UL's hope that the committee will strongly
consider the recommendations of this submission.
I. Underwriters Laboratories in Brief
Underwriters Laboratories (UL) Inc. is an independent, not-for-
profit product safety certification organization that has been testing
products and writing safety standards for more than a century. It was
founded in 1894 with a mission of testing for public safety, as defined
by its Articles of Incorporation, and strives to ensure that public
health and safety is protected through its standards development
activities and product conformity assessment services. UL has developed
and maintains more than 1000 product-based Standards for Safety,
approximately 80 percent of which have achieved American National
Standards (ANS) status.\1\ UL is a global company, with more than 25
affiliates worldwide, serving more than 71,000 manufacturers in 104
countries. In 2006, UL evaluated over 19,000 different types of
products, ranging from electrical goods to fire protection equipment,
to medical devices and lasers. Food products and non-electrical toys
are not among the products that UL currently tests and certifies.
---------------------------------------------------------------------------
\1\ ANS is a designation conferred by the American National
Standards Institute (ANSI) upon standards submitted by ANSI-accredited
Standards Development Organizations (SDO). The ANS designation is
awarded after the opportunity for public review and comment, and a
certification by the SDO that due process was followed in the
development of the standard.
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The UL Anti-Counterfeiting Program
Recognizing that consumers, retailers, regulators, manufacturers
and distributors look to the UL Mark to determine if products comply
with relevant safety standards, UL established a team of professionals
dedicated to protecting UL's intellectual property. Since 1995, UL's
anti-counterfeiting team has worked with law enforcement and educated
customs officials globally about how to identify legitimate UL
certification Marks, as well as common elements of frequently
counterfeited products.
The cost of product counterfeiting is estimated at $500 billion
(USD) annually, or roughly 5 to 7 percent of global trade. Many of the
counterfeit products entering the global market can directly and
dramatically affect the safety of the people who use them. UL practices
a zero-tolerance policy regarding counterfeit UL Marks. UL does not
consent to the import, export or manipulation of seized merchandise
bearing a counterfeit UL Mark. When products with a counterfeit UL Mark
are discovered, they are confiscated and disposed of in compliance with
all applicable laws.
I. Product Safety Challenges
A. Adulterating Products After Certification
Recent import product safety incidents (e.g. food and toys) require
an examination of the current U.S. infrastructure to ensure import
compliance and consumer protection. It is important to note that food
and (non-electrical) toys are currently not required by any U.S.
government agency to be tested and certified by an independent
laboratory in order to be sold in the U.S. marketplace. While voluntary
standards for toys have been developed by the toy industry, and are
widely used today, the Consumer Product Safety Commission (CPSC) does
not require that toys be tested and certified by independent
laboratories. Therefore, the establishment of working programs
involving third-party certification for toys and other products may be
considered as a means to provide additional oversight for products that
the U.S. government deems as posing significant risks to consumers.
UL believes independent third-party testing and certification of
products is a proven model for mitigating potential hazards associated
with manufactured products. The UL certification process is a closed-
loop system, providing a ``video perspective'' of a product from design
to distribution, rather than a mere ``snap-shot.'' During the product
investigation phase, UL engineers thoroughly test and evaluate the
product to the relevant standards that apply to it. If the product
complies with the relevant standards, UL will authorize the
manufacturer to use the UL Mark. However, UL's engagement with the
product does not end there.
UL's rigorous Follow-Up Services (FUS) program is designed to
ensure ongoing compliance of products. UL will conduct an Initial
Product Inspection (IPI), or first inspection, at the manufacturer's
site for new manufacturers, and also for existing manufacturers when
they establish product certification in a new area. Manufacturers who
utilize the UL Mark also submit to unannounced factory inspections by
UL representatives, where product is pulled from the manufacturing line
and tested to make sure that production continues to comply with the
relevant standards. As part of the inspection, UL representatives will
verify that key elements of the certified product have not changed over
time, and that critical components of the product are also compliant
with the relevant standards.
The FUS program has been an effective tool for UL to identify and
address situations where manufacturers have altered their product
without notifying UL. In some cases, changes are made that may not
affect the overall safety of the product. However, as the certifier, UL
retains the right to evaluate product changes and make this
determination if the UL Mark is to be used. In other cases,
manufacturers have intentionally adulterated products after
certification was issued, in order to cut production costs and maximize
profits. Whether the adulteration of products is independently
orchestrated by manufacturers or carried out to satisfy the demands of
importers for cheaper products, the result often has a major impact on
the products' compliance to relevant safety standards.
UL's FUS program is one means for identifying non-compliant and
potentially dangerous products. In 2006, UL completed approximately
600,000 inspection visits in over 100 countries. UL also has a robust
Field Report System, whereby UL representatives investigate any claims
of noncompliance made by consumers, manufacturers, regulatory
authorities and others. If UL receives notification that a product
bearing the UL Mark is noncompliant or was involved with a safety
incident, action is taken to identify the root cause of the concern. UL
representatives will evaluate the product to determine whether the
issue is the result of unintentional or intentional practices at the
manufacturer's site, a flaw in the standard(s) applied to the product,
misapplication or misuse of the product in the field, or some other
cause. Once this evaluation is completed, UL takes steps to rectify the
problem, working closely with the stakeholders involved, including the
manufacturer, retailer, and regulatory authority. If necessary, UL will
issue a public notice, detailing potential hazards associated with the
product and any actions that are being taken to deal with them.
UL also has a proactive Market Surveillance program in place, which
involves UL representatives visiting various retail outlets throughout
the country each year, and searching the Internet, purchasing products
bearing UL Marks and testing them to verify compliance with the
appropriate requirements. UL's Market Surveillance program is an
effective tool to ensure that products remain compliant when they
actually reach consumers.
In some cases, UL has determined that enhanced programs are
necessary to ensure compliance for certain products. In recent years,
UL has implemented such programs for products such as decorative
lighting strings, and flexible cords. In the case of decorative
lighting strings, UL's Follow-Up Services Program over the years noted
frequent incidences of noncompliance, often because such products were
adulterated after certification to make them more cost effective to
produce. One common adulteration is to limit the amount of expensive
copper used in the wiring of the products, which causes the wire gauges
to be thinner than required in the product standards, in effect posing
significant fire hazards. After discovering these noncompliance trends,
UL put in place a ``two-strikes'' policy for these products. If a
manufacturer's product is found to be noncompliant two times after UL
certification is issued, UL will revoke the right of that manufacturer
to use the UL Mark. If UL finds that a manufacturer has willfully
counterfeited, UL will withdraw certification immediately and will
refuse to do business with that manufacturer ever again. It is perhaps
an uncommon industry practice to fire one's customers, but UL's
enhanced compliance programs are, in fact, designed to do just that if
a manufacturer is not acting in good faith or is generally ineffective
in maintaining production of compliant products over time.
B. Unbranded, Counterfeit Products in the U.S. Market
Another product safety challenge, beyond products that are
adulterated after they are tested and certified, is the proliferation
of unbranded and counterfeit products in the U.S. marketplace. Over the
years, UL has witnessed a significant and growing problem of
counterfeit goods (electrical products in particular) available for
sale in the U.S. marketplace. It is clear that counterfeiters can and
will penetrate the market with poor quality, noncompliant and hazardous
products that can endanger the lives and properties of U.S. consumers.
A good example is low-cost, high-volume extension cords that can
typically be purchased for under a dollar at discount stores across the
country. These counterfeit products can cause significant property
damage, casualties, even death. These types of counterfeit electrical
cords are dangerous because to properly conduct current, an electrical
cord requires wire of a certain thickness. Counterfeit extension cords
have copper wiring so thin that when electrical current is applied they
will eventually overheat, melt and potentially catch fire. It is worth
noting that CBP vigilance and awareness has been able to determine and
seize counterfeit extension cord wiring product and thousands of
similar cords. Fire suppression devices, such as fire sprinklers,
bearing counterfeit certification marks can also pose a severe health
and safety risk to the consumer because life safety is ultimately
undermined. Substandard components and shoddy manufacturing processes
add to the counterfeiters' profit margin while putting American
consumers at risk.
For over a decade, UL has worked-closely with U.S. Customs and
Border Protection (CBP) and Immigration and Customs Enforcement (ICE)
to identify and seize products bearing counterfeit UL Marks and also
prosecute offenders to the fullest extent of the law. Since 1995, more
than 1,500 seizures of counterfeit UL products have been made by CBP,
resulting in millions of counterfeit products being blocked from entry
into the commercial marketplace (a routine inspection at the San
Francisco International Airport by a CBP officer of five suitcases
containing ``undeclared'' goods revealed 1500 counterfeit circuit
breakers that posed a serious potential fire hazard). UL also
continually conducts training for CBP and ICE at key ports of entry
throughout the United States, and works closely with the Royal Canadian
Mounted Police (RCMP) in Canada.
While UL's Anti-counterfeiting Program, with support from CBP, ICE,
DOJ and other government and law enforcement agencies, has amassed
several success stories over the years combating counterfeiting
problems, additional resources for such groups is necessary in order to
continue this positive track-record. With national security concerns
such as terrorism stretching the resources and time of our import
safety authorities, it is important for the United States to maintain
its commitment to safeguarding the public from counterfeit products. UL
strongly recommends strengthening CBP with additional personnel,
training dollars, and stricter criminal and civil penalties for
counterfeiters, especially those that counterfeit third-party
certification marks. In the past, UL has observed a general decrease in
the number of dedicated CBP officers at U.S. ports, and would encourage
additional staff and resources to be stationed at these ports as a
deterrent to counterfeiters.
UL also supports measures that would help CBP keep pace with the
sophistication of counterfeiters. This means investing in training to
help CBP staff understand changing authentication technologies, and
investment in equipment to readily assess the authenticity of product
and certification marks. This will help CBP capture copies and look for
successfully duplicated security features. UL has supported increased
risk-based modeling in cargo screening for trafficking of counterfeit
goods, and UL supports technology-based solutions that make CBP
processes more streamlined and effective. It is important to note that
technology works to the benefit of counterfeiters as well: this is why
the hands-on inspection of cargo as it crosses our borders is still
vitally important.
In June 2007 the Coalition Against Counterfeiting and Piracy (CACP)
released a multi-faceted set of recommendations to further combat
counterfeit goods. The CACP, of which UL is a member, is a broad group
established to increase understanding and awareness of counterfeiting
and piracy issues by working with the legislative and executive
branches to drive greater government-wide efforts. In general, the CACP
proposals provide for an improved strategy, new legal tools and more
resources at the U.S. Department of Homeland Security and other
agencies and Federal entities across the spectrum to better address and
respond to counterfeit and pirated goods. Beyond what has been
mentioned above, as it relates to CBP and ICE, the CACP proposals call
for training and deploying a new cadre of CBP enforcement officials
whose primary responsibility is to protect against illegal importation
and smuggling of counterfeit and pirate goods. Other recommendations
include staffing and office improvements, such as increasing funding
for the CBP Fines, Penalties and Forfeitures (FPF) office as well as
other needed regulatory and statutory reforms to improve the collection
of civil fines imposed on importers of shipments of intercepted
counterfeit products. These and other recommendations will contribute
to stopping counterfeit goods and to the ultimate goal of increased
import product safety. UL urges the legislative adoption of these
proposals. UL also supports legislation entitled the ``Intellectual
Property Rights Enforcement Act'' (S. 522/H.R. 3578) introduced by
Senator Bayh and Representative Sherman. The legislation increases the
coordination among Federal agencies charged with intellectual property
rights enforcement, strengthens international enforcement, and calls
for the creation of a strategic plan to address intellectual property
theft.
C. Products Found to be Non-Compliant with Voluntary Standards
Mandatory product safety standards exist for a variety of
industries to protect the public from unsafe imports and non-compliant
product that may get shipped to U.S. ports. However, recent events have
shown that oftentimes products are not compliant with available U.S.
voluntary standards widely used by the industry.
The United States is unique to the world in many ways, including
the fact that it relies heavily on the private sector for voluntary
standards development, as well as product safety testing and
certification services. Under the auspices of the 1996 National
Technology Transfer and Advancement Act (NTTAA), U.S. government
agencies are encouraged to rely on voluntary consensus standards (VCS)
and conformity assessment practices whenever applicable and
appropriate. While our government generally has not driven the
standards development process, it has been an active participant and
partner. Federal, State, and local governments develop and issue
procurement specifications and mandatory codes, rules, and regulations.
The U.S. system, although decentralized, effectively serves the needs
of all stakeholders. It promotes comprehensive expertise by encouraging
participation of all public and private technical experts. Openness,
balance, consensus, and due process are the fundamental principles of
the American National Standards process.
Since the private sector drives standards development in the United
States, private bodies maintain ownership of the intellectual property
contained in most of the standards used in the U.S. marketplace. While
this has created challenges to forming one, central repository for
U.S.-based standards, private sector standards developers have strived
to make their standards readily available to users in the United
States, and abroad. All UL standards are available and easily
accessible on our public website. UL recently made all of its published
standards available to our customers, free of charge. UL also
formalized a memorandum of understanding (MOU) structure in 2006 to
provide UL standards, free of charge, to national standards bodies in
developing countries, to use in their committees and also reference in
their own national regulations.
UL and the U.S. Consumer Product Safety Commission (CPSC) have long
been partners in carrying out our common mission to safeguard the
public from product safety hazards. With regard to cooperation between
the CPSC and the CBP, UL would note the proposal offered by CPSC Acting
Chairman Nord entitled the ``Product Recall Information and Safety
Modernization'' (PRISM) proposal, address changes to the Commission's
original authorizing act. A specific PRISM proposal would further allow
CPSC to block non-complying imports into the United States. Currently,
CPSC can only block entry of products when imports do not meet
mandatory requirements. Under the PRISM proposal, CPSC or CBP could
block entry of imports failing to comply with certain voluntary
standards (upon which CPSC would formally rely). The provisions,
moreover, would require the importer to post a bond sufficient to cover
the cost of destroying confiscated shipments of product. UL commends
this provision, as it provides added incentives for better supply chain
management, and urges strengthening the cooperation between the CPSC
and CBP.
III. Conclusion
CBP and ICE officers are an important line of protection in the
fight against counterfeit and unsafe products. UL appreciates and
applauds the dedication of CBP and ICE to protecting the American
public and it is critically important to remain vigilant: while third-
party certification works for many industries, and vigorous follow-up
is able to catch a significant amount of non-compliant product, it is
crucial that port authorities be adequately resourced, staffed and have
strong tools to address counterfeit and unsafe products. CBP and ICE
must be adequately supported to sustain the fight against not only
terrorist activity, but also the more subtle threats of counterfeits
that ultimately jeopardize and undermine the American way of life. UL
would be pleased to remain a resource to the Committee on Ways and
Means on this and other matters of interest.