[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




                  U.S. GOVERNMENT PRINTING OFFICE
49-993                    WASHINGTON : 2009
-----------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Printing 
Office  Internet: bookstore.gov Phone: toll free (866) 512-1800; DC area 
(202) 512-1800 Fax: (202) 512-2104  Mail: Stop IDCC, Washington, DC 
20402-0001


                      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 
version. Because electronic submissions are used to prepare both 
printed and electronic versions of the hearing record, the process of 
converting between various electronic formats may introduce 
unintentional errors or omissions. Such occurrences are inherent in the 
current publication process and should diminish as the process is 
further refined.


                            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 
for the hearing record must follow the appropriate link on the hearing 
page of the Committee website and complete the informational forms. 
From the Committee homepage, http://waysandmeans.house.gov, select 
``110th Congress'' from the menu entitled, ``Hearing Archives'' (http:/
/waysandmeans.house.gov/Hearings.asp?congress=18). Select the hearing 
for which you would like to submit, and click on the link entitled, 
``Click here to provide a submission for the record.'' Once you have 
followed the online instructions, completing all informational forms 
and clicking ``submit'' on the final page, an email will be sent to the 
address which you supply confirming your interest in providing a 
submission for the record. You MUST REPLY to the email and ATTACH your 
submission as a Word or WordPerfect document, in compliance with the 
formatting requirements listed below, by close of business Thursday, 
October 18, 2007. Finally, please note that due to the change in House 
mail policy, the U.S. Capitol Police will refuse sealed-package 
deliveries to all House Office Buildings. Those filing written 
statements who wish to have their statements distributed to the press 
and interested public at the hearing can follow the same procedure 
listed above for those who are testifying and making an oral 
presentation. For questions, or if you encounter technical problems, 
please call (202) 225-1721.
      

FORMATTING REQUIREMENTS:

      
    The Committee relies on electronic submissions for printing the 
official hearing record. As always, submissions will be included in the 
record according to the discretion of the Committee. The Committee will 
not alter the content of your submission, but we reserve the right to 
format it according to our guidelines. Any submission provided to the 
Committee by a witness, any supplementary materials submitted for the 
printed record, and any written comments in response to a request for 
written comments must conform to the guidelines listed below. Any 
submission or supplementary item not in compliance with these 
guidelines will not be printed, but will be maintained in the Committee 
files for review and use by the Committee.
      
    1. All submissions and supplementary materials must be provided in 
Word or WordPerfect format and MUST NOT exceed a total of 10 pages, 
including attachments. Witnesses and submitters are advised that the 
Committee relies on electronic submissions for printing the official 
hearing record.
      
    2. Copies of whole documents submitted as exhibit material will not 
be accepted for printing. Instead, exhibit material should be 
referenced and quoted or paraphrased. All exhibit material not meeting 
these specifications will be maintained in the Committee files for 
review and use by the Committee.
      
    3. All submissions must include a list of all clients, persons, 
and/or organizations on whose behalf the witness appears. A 
supplemental sheet must accompany each submission listing the name, 
company, address, telephone and fax numbers of each witness.
      
    Note: All Committee advisories and news releases are available on 
the World Wide Web at http://waysandmeans.house.gov
      
    The Committee seeks to make its facilities accessible to persons 
with disabilities. If you are in need of special accommodations, please 
call 202-225-1721 or 202-226-3411 TTD/TTY in advance of the event (four 
business days notice is requested). Questions with regard to special 
accommodation needs in general (including availability of Committee 
materials in alternative formats) may be directed to the Committee as 
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

[GRAPHIC] [TIFF OMITTED] 49993A.001

[GRAPHIC] [TIFF OMITTED] 49993A.002

[GRAPHIC] [TIFF OMITTED] 49993A.003

[GRAPHIC] [TIFF OMITTED] 49993A.004

[GRAPHIC] [TIFF OMITTED] 49993A.005

[GRAPHIC] [TIFF OMITTED] 49993A.006

[GRAPHIC] [TIFF OMITTED] 49993A.007

[GRAPHIC] [TIFF OMITTED] 49993A.008

[GRAPHIC] [TIFF OMITTED] 49993A.009

[GRAPHIC] [TIFF OMITTED] 49993A.010

[GRAPHIC] [TIFF OMITTED] 49993A.011

[GRAPHIC] [TIFF OMITTED] 49993A.012

[GRAPHIC] [TIFF OMITTED] 49993A.013

[GRAPHIC] [TIFF OMITTED] 49993A.014


                                 

    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

[GRAPHIC] [TIFF OMITTED] 49993A.015

[GRAPHIC] [TIFF OMITTED] 49993A.016

[GRAPHIC] [TIFF OMITTED] 49993A.017

[GRAPHIC] [TIFF OMITTED] 49993A.018

[GRAPHIC] [TIFF OMITTED] 49993A.019

[GRAPHIC] [TIFF OMITTED] 49993A.020

[GRAPHIC] [TIFF OMITTED] 49993A.021

[GRAPHIC] [TIFF OMITTED] 49993A.022

[GRAPHIC] [TIFF OMITTED] 49993A.023


                                 

    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \13\ Interagency Working Group on Import Safety, Protecting 
American Consumers Every Step of the Way, September 10, 2007.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \14\ Public Citizen, NAFTA's Threat to Sovereignty and Democracy: 
The Record of NAFTA Chapter 11 Investor-State Cases 1994-2005, February 
2005.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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'').
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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/.
---------------------------------------------------------------------------
    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
[GRAPHIC] [TIFF OMITTED] 49993A.029

[GRAPHIC] [TIFF OMITTED] 49993A.030

[GRAPHIC] [TIFF OMITTED] 49993A.031

[GRAPHIC] [TIFF OMITTED] 49993A.032

[GRAPHIC] [TIFF OMITTED] 49993A.033


                                 

    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

[GRAPHIC] [TIFF OMITTED] 49993A.034

[GRAPHIC] [TIFF OMITTED] 49993A.035

[GRAPHIC] [TIFF OMITTED] 49993A.036

[GRAPHIC] [TIFF OMITTED] 49993A.037

[GRAPHIC] [TIFF OMITTED] 49993A.038

[GRAPHIC] [TIFF OMITTED] 49993A.039

[GRAPHIC] [TIFF OMITTED] 49993A.040

[GRAPHIC] [TIFF OMITTED] 49993A.041

[GRAPHIC] [TIFF OMITTED] 49993A.042

[GRAPHIC] [TIFF OMITTED] 49993A.043

[GRAPHIC] [TIFF OMITTED] 49993A.044


                                 

    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:]
    [GRAPHIC] [TIFF OMITTED] 49993A.045
    
    [GRAPHIC] [TIFF OMITTED] 49993A.046
    
    [GRAPHIC] [TIFF OMITTED] 49993A.047
    
    [GRAPHIC] [TIFF OMITTED] 49993A.048
    

                                 

    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.
---------------------------------------------------------------------------
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.

                                  
