[House Hearing, 108 Congress]
[From the U.S. Government Publishing Office]
IMPLEMENTATION OF THE FOOD SECURITY PROVISIONS OF THE PUBLIC HEALTH
SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT
=======================================================================
HEARING
before the
SUBCOMMITTEE ON HEALTH
of the
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED EIGHTH CONGRESS
SECOND SESSION
__________
JUNE 25, 2004
__________
Serial No. 108-114
__________
Printed for the use of the Committee on Energy and Commerce
Available via the World Wide Web: http://www.access.gpo.gov/congress/
house
__________
U.S. GOVERNMENT PRINTING OFFICE
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------------------------------
COMMITTEE ON ENERGY AND COMMERCE
JOE BARTON, Texas, Chairman
W.J. ``BILLY'' TAUZIN, Louisiana JOHN D. DINGELL, Michigan
RALPH M. HALL, Texas Ranking Member
MICHAEL BILIRAKIS, Florida HENRY A. WAXMAN, California
FRED UPTON, Michigan EDWARD J. MARKEY, Massachusetts
CLIFF STEARNS, Florida RICK BOUCHER, Virginia
PAUL E. GILLMOR, Ohio EDOLPHUS TOWNS, New York
JAMES C. GREENWOOD, Pennsylvania FRANK PALLONE, Jr., New Jersey
CHRISTOPHER COX, California SHERROD BROWN, Ohio
NATHAN DEAL, Georgia BART GORDON, Tennessee
RICHARD BURR, North Carolina PETER DEUTSCH, Florida
ED WHITFIELD, Kentucky BOBBY L. RUSH, Illinois
CHARLIE NORWOOD, Georgia ANNA G. ESHOO, California
BARBARA CUBIN, Wyoming BART STUPAK, Michigan
JOHN SHIMKUS, Illinois ELIOT L. ENGEL, New York
HEATHER WILSON, New Mexico ALBERT R. WYNN, Maryland
JOHN B. SHADEGG, Arizona GENE GREEN, Texas
CHARLES W. ``CHIP'' PICKERING, KAREN McCARTHY, Missouri
Mississippi, Vice Chairman TED STRICKLAND, Ohio
VITO FOSSELLA, New York DIANA DeGETTE, Colorado
STEVE BUYER, Indiana LOIS CAPPS, California
GEORGE RADANOVICH, California MICHAEL F. DOYLE, Pennsylvania
CHARLES F. BASS, New Hampshire CHRISTOPHER JOHN, Louisiana
JOSEPH R. PITTS, Pennsylvania TOM ALLEN, Maine
MARY BONO, California JIM DAVIS, Florida
GREG WALDEN, Oregon JANICE D. SCHAKOWSKY, Illinois
LEE TERRY, Nebraska HILDA L. SOLIS, California
MIKE FERGUSON, New Jersey CHARLES A. GONZALEZ, Texas
MIKE ROGERS, Michigan
DARRELL E. ISSA, California
C.L. ``BUTCH'' OTTER, Idaho
JOHN SULLIVAN, Oklahoma
Bud Albright, Staff Director
James D. Barnette, General Counsel
Reid P.F. Stuntz, Minority Staff Director and Chief Counsel
______
Subcommittee on Health
MICHAEL BILIRAKIS, Florida, Chairman
RALPH M. HALL, Texas SHERROD BROWN, Ohio
FRED UPTON, Michigan Ranking Member
JAMES C. GREENWOOD, Pennsylvania HENRY A. WAXMAN, California
NATHAN DEAL, Georgia EDOLPHUS TOWNS, New York
RICHARD BURR, North Carolina FRANK PALLONE, Jr., New Jersey
ED WHITFIELD, Kentucky BART GORDON, Tennessee
CHARLIE NORWOOD, Georgia ANNA G. ESHOO, California
Vice Chairman BART STUPAK, Michigan
BARBARA CUBIN, Wyoming ELIOT L. ENGEL, New York
JOHN SHIMKUS, Illinois GENE GREEN, Texas
HEATHER WILSON, New Mexico TED STRICKLAND, Ohio
JOHN B. SHADEGG, Arizona DIANA DeGETTE, Colorado
CHARLES W. ``CHIP'' PICKERING, LOIS CAPPS, California
Mississippi CHRIS JOHN, Louisiana
STEVE BUYER, Indiana BOBBY L. RUSH, Illinois
JOSEPH R. PITTS, Pennsylvania JOHN D. DINGELL, Michigan,
MIKE FERGUSON, New Jersey (Ex Officio)
MIKE ROGERS, Michigan
JOE BARTON, Texas,
(Ex Officio)
(ii)
C O N T E N T S
__________
Page
Testimony of:
Cady, John R., President and CEO, National Food Processors
Association................................................ 28
Clarke, Roger, Williams and Clarke Company................... 33
Crawford, Lester M., Acting Commissioner, Food and Drug
Administration............................................. 5
French, David, Senior Vice President, Government Relations,
International Foodservice Distributors Association......... 37
Sauceda, Cathy, Director, Special Enforcement Division, U.S.
Customs and Border Protection.............................. 11
Saunders, R. Douglas, Chair, Association of Food and Drug
Officials (AFDO) Food Security Task Force, accompanied by
Betsy Woodward, Special Advisor to the AFDO Board of
Directors.................................................. 46
Stout, Susan M., Vice President of Federal Affairs, Grocery
Manufacturers of America................................... 42
Additional material submitted for the record:
Cady, John R., President and CEO, National Food Processors
Association, letter dated August 9, 2004, enclosing
response for the record.................................... 60
French, David, Senior Vice President, Government Relations,
International Foodservice Distributors Association, letter
dated August 9, 2004, enclosing response for the record.... 63
Stout, Susan M., Vice President of Federal Affairs, Grocery
Manufacturers of America, letter dated August 9, 2004,
enclosing response for the record.......................... 65
Ronan, Patrick, Assistant Commissioner for Legislation, Food
and Drug Administration, Department of Health and Human
Services:
Letter dated October 7, 2004, to Hon. Michael Bilirakis,
enclosing response for the record...................... 68
Letter dated September 13, 2004, to Hon. John D. Dingell,
enclosing response for the record...................... 77
(iii)
IMPLEMENTATION OF THE FOOD SECURITY PROVISIONS OF THE PUBLIC HEALTH
SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT
----------
FRIDAY, JUNE 25, 2004
House of Representatives,
Committee on Energy and Commerce,
Subcommittee on Health,
Washington, DC.
The subcommittee met, pursuant to notice, at 9:34 a.m., in
room 2123, Rayburn House Office Building, Hon. Michael
Bilirakis (chairman) presiding.
Members present: Representatives Bilirakis, Shimkus, Brown,
Stupak, Green, and Capps.
Staff present: Nandan Kenkeremath, majority counsel; Jeremy
Allen, policy coordinator; Ryan Long, majority professional
staff; Michael Abraham, legislative clerk; Edith Holleman,
minority counsel; and Voncille Hines, minority professional
staff.
Mr. Bilirakis. I am going to call this hearing to order.
Mr. Brown, as I understand it, is on his way. So he will
probably be here before I finish up.
This morning we will hold our second hearing this year on
Homeland Security programs within this committee's
jurisdiction. In May, we held a legislative hearing focused on
ways to improve H.R. 3266, the Faster and Smarter Funding for
First Responders Act, a bill originally drafted by the Select
Committee on Homeland Security. Subsequent to our hearing,
changes were made to that legislation to address the concerns
this committee had with the legislation, which we supported.
Today, however, we will be focusing on the implementation
of one of the most important pieces of legislation this
committee has produced over the past several years. The Public
Health Security and Bioterrorism Preparedness and Response Act
of 2002 represents Congress' bipartisan response to the dire
threat caused by biological, chemical, and radiological
weapons. This law has gone a long way toward improving our
ability to prevent an attack of this nature. This hearing will
focus on the food safety provisions contained in the act.
Congress provided the Food and Drug Administration with new
authority to ensure the safety of our food supply.
Specifically, the new law requires the registration of food
processors, the prior notification of proposed food imports,
the establishment and maintenance of records, and new
administrative food detention authority. The FDA published two
interim final rules on October 10 of last year to implement
these provisions.
I am pleased that Dr. Lester Crawford, the Acting
Commissioner of the FDA, is here to discuss these regulations
with us this morning. It is always a pleasure to welcome you to
our subcommittee, sir.
These rules are designed to help domestic and foreign food
establishments minimize the risk that food under their control
could be subject to intentional contamination.
The rules were implemented on December 12, 2003, but, as I
am sure Dr. Crawford will point out, FDA has asked its
inspectors to flexibly enforce while affected establishments
and traders become accustomed to the new system. I am also
interested in learning more about the extended education
program here and abroad to inform participants along the farm
to table continuum about the new requirements.
I am also glad that Ms. Cathy Sauceda, the Director of the
Special Enforcement Division of the U.S. Bureau of Customs and
Border Protection, is here. Your insight of course into the
collaboration between FDA and Customs should prove valuable,
and we certainly welcome you here this morning.
As we work to fine-tune our Nation's ability to respond to
attacks on our homeland, I am very interested in how different
agencies interact. While we can do great things when agencies
with differing expertise work together, I want us all to remain
vigilant in ensuring that duplication of efforts doesn't result
in wasted resources.
Finally, I am pleased that our second panel contains a
number of affected stakeholders. I know that the food
processing and distribution industry have worked closely with
Congress and with the FDA to ensure that the 2002 Bioterrorism
Prevention Act is properly implemented. I am aware of your
testimony that some of you do have concerns, and I am
interested in hearing them. And I would hope, by the way, Dr.
Crawford, at this point I realize--I know that you have to
leave, and we will let you go just as soon as you have to
leave, about 10:30. But if you could have someone from your
office stay in the audience so they might take notes as we
listen to these affected stakeholders, it could really be
helpful. Thank you.
Open dialog between all interested parties is critical to
the success of the law. This is an important hearing, and I
want to once again--we worked late last night, to well after
midnight, and so I think people will be streaming in little by
little. But in any case, that is the reason we have hardly
anyone else here. But I do want to thank you again for joining
us this morning. And, with that, I am very happy to yield to
the ranking member for an opening statement. He looks pretty
good for having been up that late.
Mr. Brown. Thanks, Mr. Chairman.
Food security provisions of the 2002 bioterrorism law
recognize the very real challenge of food import security, and
they give the FDA the tools to meet that challenge. The task
before you and for us is a challenging one, to be sure.
Protecting the food supply of a country as big and open as the
United States from the threat of bioterrorism is a difficult
proposition. Fifteen percent of vegetables consumed in the U.S.
are imported, 40 percent of the food we eat, 55 percent of the
seafood that we consume. In all, we import 5 million shipments
of food every year under FDA's jurisdiction. The challenge we
face is a serious one but not insurmountable.
The 2002 law gives FDA powerful new legal tools. It
requires foreign facilities that are in America's food chain to
register with the FDA, requires importers to give FDA prior
notice before shipment arrives, requires that businesses in our
food chain maintain records necessary to permit effective
trace-backs in an emergency, allows detention of a shipment if
FDA believes it may pose a threat, and allows FDA to disbar
companies with a track record of noncompliance.
FDA has received hundreds of millions of dollars in
additional appropriations to implement the new law, and FDA has
used these resources to both beef up technology, improve
systems, and hire hundreds of new field agents, lab analysts,
criminal investigators, and other professionals who can put
these new security protections into effect. So I say one of the
strengths of the 2002 act is its flexibility. The law gives FDA
significant discretion in key areas to ensure that requirements
like facility registration and prior notice are tailored to
provide maximum protection for the public and minimum
compliance burden for industry.
Industry has raised some concerns about the actual
implementation. These are serious considerations, and as this
hearing demonstrates, Congress is serious about getting the
implementation with you right.
But let me be clear. The 2002 act gives FDA ample
flexibility to address legitimate concerns. I stand ready to
work with industry to improve the system within the framework
of current law, And I look forward to the testimonies of our
witnesses.
Mr. Bilirakis. I thank the gentleman, and I would now yield
to the gentleman from Illinois, Mr. Shimkus.
Mr. Shimkus. Thank you, Mr. Chairman.
And I guess one of the few conferences that I was ever to
be able to be a part of was this one, and so I am here with
great interest to hear how the legislation and actually the
implementation is moving forward.
We have a great food safety program here in this country.
The concerns of the world are still prevalent and very evident.
I, like many, will want to ensure that, as best as possible,
that we are maintaining that food safety supply without that
now that very dangerous opportunity of destroying the small
businesses that will become overwhelmed by the bureaucratic
efforts to maintain them in this new environment. I think there
is great concern. The more government we have to have to
intervene to protect, really, the bigger the organizations have
to be and the larger staffs and the more legal advice and the
more clerks to comply. And that is good in major corporations
of large sizes, but as we say so much here in Washington, it is
the smaller institutions, sole proprietorships, and the
partnerships and stuff that people who are trying to administer
and make the country grow are also trying to do those other
areas. And this area is even more challenging with the safety
implications of what we are talking about.
So that is my concern, and I think that will be raised by
other members. I look forward to hearing this, and I thank you
for your attendance. And, Mr. Chairman, I yield back the
balance of my time.
Mr. Bilirakis. I thank the gentleman.
Does Mr. Stupak have an opening statement?
Mr. Stupak. I will waive, Mr. Chairman.
Mr. Bilirakis. Thank you, sir.
[Additional statement submitted for the record follows:]
Prepared Statement of Hon. Joe Barton, Chairman, Committee on Energy
and Commerce
Thank you Mr. Chairman for holding this hearing. I would also like
to thank our witnesses for agreeing to testify about this important
subject.
The terrorist attacks of September 11, 2001, and the subsequent
anthrax attack on the Capitol transformed our understanding of the
threats facing our nation. We have been forced to assess the risks of
unconventional attacks that were previously un-imagined. We have also
identified frightening vulnerabilities that could be used to threaten
the safety of millions of Americans.
One area of particular concern that was identified after 9-11 was
the vulnerability associated with a possible terrorist threat to our
food supply. Under the leadership of this Committee, Congress responded
to this threat by passing the Public Health Security and Bioterrorism
Preparedness and Response Act.
The new law will protect our food supply by broadening the FDA's
authority to better track and prevent potential food adulteration and
to give the agency more information about the food supply. The new law
authorizes FDA to register food processors, require advance
notification on imports and impound suspicious shipments.
The new law will require continuing collaboration between industry,
the regulating agencies, and Congress in order to allow the successful
implementation of the new requirements.
This hearing will provide a forum to discuss implementation of the
Act up to this point, and allow for comments on how best to proceed
forward. I am pleased to hear that the FDA has been receptive to
industry suggestions on how to implement the Bioterrorism Act. I also
want to learn the status of current efforts to register food processors
in order to ensure a seamless transition to the new regulatory
structure that is slated to begin in August.
Congress, the Administration, and industry have an obligation to
continue to work together to balance the economic demands for the free
flow of commerce while securing our nations food supply. This hearing
will provide us with an opportunity to review all of our efforts to
date and determine what more needs to be done. Thank you again Mr.
Chairman for holding this important hearing and I yield back the
balance of my time.
Mr. Bilirakis. Let us go right into the panel then.
The first panel consists of, as I have already indicated,
Dr. Lester Crawford, as the Acting Commissioner of the FDA, and
Ms. Cathy Sauceda, Director of the Special Enforcement Division
with U.S. Customs and Border Protection.
I am going to set the clock to 5 minutes, but by all means,
if you haven't completed your statement, please continue on.
Don't worry about the time.
Dr. Crawford, we will start off with you. Thank you, sir.
Your written statements of course are a part of the record, so
we would hope you would complement and supplement those. And
the written opening statements of all members of the
subcommittee, without objection, will be made a part of the
record.
Please proceed, sir.
STATEMENTS OF LESTER M. CRAWFORD, ACTING COMMISSIONER, FOOD AND
DRUG ADMINISTRATION; AND CATHY SAUCEDA, DIRECTOR, SPECIAL
ENFORCEMENT DIVISION, U.S. CUSTOMS AND BORDER PROTECTION
Mr. Crawford. Thank you very much. It is a pleasure to be
here, and I appreciate the invitation, Mr. Chairman, members of
the subcommittee. I am also pleased to be here with my
colleague Cathy Sauceda from Customs and Border Protection.
Thank you very much for all you have done to help us in this
effort and to work together.
Thank you for this opportunity to discuss FDA's actions to
implement the food safety provisions in the Public Health
Security and Bioterrorism Preparedness and Response Act of
2002. I wish to thank the members of this subcommittee for your
leadership in enacting this landmark legislation. The
Bioterrorism Act has provided us with significant new tools to
protect the Nation's food supply against the threat of
intentional contamination and other food-related emergencies.
FDA regulates 80 percent of the Nation's food supply,
everything we eat except for meat, poultry, and certain egg
products. FDA's responsibility extends to live food animals and
to animal feed.
Since the Bioterrorism Act was signed into law just over 2
years ago, FDA has been working hard to implement this law
effectively and efficiently. Section 305 of this act requires
registration of foreign and domestic food facilities that
manufacture, process, pack, or hold food for consumption by
humans or animals in the United States. FDA will have for the
first time a roster of foreign and domestic food facilities
that provide food for American consumers. In the event of a
potential or actual terrorist incident or an outbreak of food-
borne illness, the registration information will help FDA to
quickly identify, locate, and notify the facilities that may be
affected. On October 10, 2003, FDA and CBP jointly published an
interim final regulation to implement the registration
requirement.
Section 307 of the act requires submission to FDA of prior
notice of food, including animal feed, that is imported or
offered for import into the United States. This advance
information enables FDA, working closely with CBP, to more
effectively target inspections at the border to ensure the
safety of imported foods before they move into the U.S.
On October 10, 2003, FDA and CBP jointly published an
interim final regulation to implement this provision. Since
this rule became effective on December 12 last, we have
processed approximately 4 million prior notice submissions. We
recently reopened and extended the public comment period on
this rule through July 13, 2004.
Last December, CBP and FDA issued a compliance policy guide
that explains our intention to focus initially on educating
affected firms and individuals about the new requirement while
gradually phasing in enforcement. This phase-in period will end
August 12, at which time routine enforcement will begin.
This week, FDA, with CBP concurrence, announced that we
would continue our policy of focusing on education for certain
noncommercial shipments until the final rule is published. We
took this action in response to concerns about different kinds
of noncommercial shipments such as household goods that contain
food items and shipments by individuals sent through
international mail or express carriers for noncommercial
purposes.
Section 306 of the Bioterrorism Act authorizes FDA to have
access to certain records when FDA has a reasonable belief that
an article of food is adulterated and presents a threat of
serious adverse health consequences or death to humans or
animals.
On May 9 of last year, FDA published a proposed rule to
implement this section. We intend to issue a final rule in the
near future. When finalized, the recordkeeping regulations will
help FDA track and contain foods that pose a serious threat.
Section 314 of the act authorizes FDA to commission other
Federal officers and employees to conduct examinations and
investigations. FDA and CBP have signed a memorandum of
understanding to commission CBP officers to conduct
investigations and examinations on FDA's behalf.
I am pleased to report, Mr. Chairman, that some 8,100 CBP
officials have been commissioned and trained in FDA activities.
This collaboration significantly strengthens our ability to
secure the border while ensuring the movement of legitimate
trade.
Section 303 of the Bioterrorism Act gives FDA new authority
to administratively detain any article of food for which FDA
has credible evidence or information that the food presents a
threat of serious adverse health consequences or death to
humans or animals. On June 4 of this year, FDA published a
final rule that included expedited procedures for perishable
foods as well as procedures describing how FDA will detain an
article of food and the process for appealing a detention
order.
Thank you very much for having me here. I look forward to
comments and questions. Thank you, sir.
[The prepared statement of Lester M. Crawford follows:]
Prepared Statement of Lester M. Crawford, Acting Commissioner, Food and
Drug Administration
INTRODUCTION
Good morning, Chairman Bilirakis and Members of the Subcommittee. I
am Dr. Lester M. Crawford, Acting Commissioner of the Food and Drug
Administration (FDA or the Agency), which is part of the Department of
Health and Human Services (HHS or the Department). I am pleased to be
here today with my colleague, Ms. Cathy Sauceda from Customs and Border
Protection (CBP) in the Department of Homeland Security (DHS). Thank
you for this opportunity to discuss FDA's actions to implement the food
safety provisions in Title III, Subtitle A--Protection of Food Supply--
in the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (Bioterrorism Act). I wish to thank the Members of
this Subcommittee for your leadership in enacting this landmark
legislation. This legislation represents the most fundamental
enhancement to our food safety authorities in many years. As you know,
it provided us with significant new tools to protect the nation's food
supply against the threat of intentional contamination and other food-
related emergencies. Implementing these new authorities has been a top
priority for FDA.
In my testimony today, I will first provide some background on HHS'
food safety responsibilities. Then, I will describe the many actions
FDA has taken to implement the food safety provisions in the
Bioterrorism Act.
HHS' FOOD SAFETY RESPONSIBILITIES
FDA is the Federal agency that regulates 80 percent of the nation's
food supply(everything we eat except for meat, poultry, and certain egg
products, which are regulated by our partners at the United States
Department of Agriculture (USDA). FDA's responsibility extends to live
food animals and animal feed. FDA is also responsible for ensuring that
human drugs, human biological products, medical devices, and
radiological products as well as veterinary drugs are safe and
effective, and that cosmetics are safe. In addition, FDA is responsible
for assuring that the health consequences of foods and medicines are
accurately and honestly represented to the public, so that they can be
used as effectively as possible to protect and improve the public
health.
While FDA has the lead responsibility within HHS for ensuring the
safety of food products, the Centers for Disease Control and Prevention
(CDC) within HHS has an important complementary and non-regulatory
public health role. As the lead Federal agency for conducting disease
surveillance, CDC monitors the occurrence of illness in the U.S.
attributable to the entire food supply. The disease surveillance
systems coordinated by CDC, in which FDA participates, provide an
essential early-information network to detect dangers in the food
supply and to reduce foodborne illness. In addition, these systems can
be used to indicate new or changing patterns of foodborne illness.
Because CDC detects and investigates outbreaks of foodborne illness
through its networks, CDC is able to alert FDA and USDA about
implicated food products associated with an outbreak and works closely
with the agencies to take protective public health action. In keeping
with its agency mission, CDC also identifies, evaluates, and offers
expert scientific opinion on the effectiveness of foodborne disease
prevention strategies.
FDA contributes to the Foodborne Diseases Active Surveillance
Network (FoodNet), the principal foodborne disease component of CDC's
Emerging Infections Program (EIP). FoodNet is a collaborative activity
of CDC, FDA, the Food Safety and Inspection Service of USDA, and ten
EIP sites, (California, Colorado, Connecticut, Georgia, New York,
Maryland, Minnesota, Oregon, Tennessee, and New Mexico). Through this
active surveillance system, these sites actively seek out information
on foodborne illnesses identified by clinical laboratories, collect
information from patients about their illnesses, and conduct
investigations to determine which foods are linked to specific
pathogens. This surveillance system provides important information
about changes over time in the burden of foodborne diseases. These data
help public health and food safety agencies evaluate the effectiveness
of current food safety initiatives and develop future food safety
activities. FDA provides both monetary support and technical expertise
to the program.
In addition, just as FDA works with Federal, state, and local food
safety counterparts, CDC works extensively with Federal, state, and
local health departments to build their epidemiology, laboratory, and
environmental health expertise in foodborne disease surveillance and
outbreak response. All of these collaborations draw on and apply the
unique expertise within HHS to address significant and emerging
challenges to our food supply.
IMPLEMENTATION OF SUBTITLE A OF TITLE III OF THE BIOTERRORISM ACT
Subtitle A of Title III of the Bioterrorism Act provides the
Secretary of Health and Human Services with new authorities to protect
the nation's food supply against the threat of intentional
contamination and other food-related emergencies. FDA is responsible
for implementing these provisions. These new authorities improve our
ability to act quickly in responding to a threatened or actual
terrorist attack, as well as other food-related emergencies. Since this
legislation was signed into law just over two years ago, FDA has been
working hard to implement this law effectively and efficiently.
Throughout this process, FDA has enjoyed close cooperation from our
colleagues at CBP.
Registration of Food Facilities
Section 305 of the Bioterrorism Act requires registration of
foreign and domestic food facilities that manufacture, process, pack,
or hold food for consumption by humans or animals in the U.S.. Thanks
to this provision, FDA will have, for the first time, a roster of
foreign and domestic food facilities that provide food for American
consumers. In the event of a potential or actual terrorist incident or
an outbreak of foodborne illness, the registration information will
help FDA to quickly identify, locate, and notify the facilities that
may be affected.
On October 10, 2003, FDA and CBP jointly published an interim final
regulation to implement the registration requirement. This regulation
became effective on December 12, 2003. We have provided two public
comment periods that allowed a total of 105 days for interested parties
to comment on certain provisions in the interim final rule. We
currently intend to publish the final rule in the spring of 2005 after
considering all the timely comments we have received.
FDA's electronic registration system became operational on October
16, 2003, which allowed facilities almost two months to register with
FDA before the regulation became effective. We worked hard to develop
an electronic system that is easy to use. The system is available 24
hours a day, seven days a week, to anyone with access to the Internet.
We are also providing technical assistance to persons who need help
with the registration process. The electronic system will provide the
facility with its registration number nearly instantaneously upon
successful completion of the registration process. While facilities are
not required to register electronically, FDA strongly encourages
facilities to use the electronic system to register. Although it will
take longer for facilities that register by mail to receive their
registration numbers, registration by paper also is relatively easy to
accomplish. As of June 24, 2004, 208,277 facilities have registered.
This includes 98,896 domestic and 109,381 foreign facilities.
Our goal has been to phase-in enforcement of the registration rule
in a manner that ensures a smooth transition with minimal effect on
commerce. Last December, FDA published two Compliance Policy Guides
that stated our intention to focus initially on educating industry
about how to comply with the new registration requirement. For domestic
facilities, FDA expects it typically would discover a registration
violation during a routine inspection and would enforce the
registration provision as appropriate in each situation. Circumstances
that could merit regulatory action include a continuing failure to
register or a threat to the food supply associated with food from an
unregistered facility. In addition, FDA may consider the failure to
register as an additional charge in an enforcement action that is based
on other statutory violations. Regarding foreign facilities, Section
305 states that food from a foreign facility that is required to
register, but has not done so, must be held at the port of entry until
the facility is registered. Accordingly, FDA is enforcing the
registration requirement for manufacturers and shippers through the
prior notice interim final rule, which I will discuss in a moment. In
most cases, the failure of a facility, domestic or foreign, to be
registered is a violation that can be readily corrected. As mentioned
above, electronic registration may be accomplished with minimal effort.
Thus, the ability to remedy a failure to register is relatively
straightforward for both domestic and foreign facilities.
Prior Notice of Imported Food Shipments
Section 307 of the Bioterrorism Act requires the submission to FDA
of prior notice of food, including animal feed, that is imported or
offered for import into the U.S. This advance information enables FDA,
working closely with CBP, to more effectively target inspections at the
border to ensure the safety of imported foods before they move into the
U.S. On October 10, 2003, FDA and CBP jointly published an interim
final rule to implement this provision. This regulation became
effective on December 12, 2003. We recently reopened and extended the
public comment period on the Prior Notice Interim Final Rule for an
additional 60 days. Comments will be accepted through July 13, 2004.
Interested parties will have had a total of 165 days to comment on the
provisions. We currently intend to publish the final rule in March
2005. Since December 2003, we have been receiving approximately 150,000
notifications each week about articles of food being imported or
offered for import into the U.S.
FDA and CBP worked collaboratively to ensure the new regulations
promote a coordinated strategy for border protection. Thanks to this
collaboration, prior notice may be submitted electronically either by
licensed brokers using CBP's Automated Commercial System (ACS) or by
anyone using FDA's Prior Notice System Interface. FDA's and CBP's
systems are linked together. Regardless of which system a submitter
uses to transmit the prior notice to FDA, the notices submitted are
reviewed in the same timeframes and in accordance with the same
procedures.
Based on FDA's current assessment, the timeframes in the interim
final rule for submitting prior notice are the least amount of time
that FDA needs to meet our statutory responsibility to receive, review,
and respond to the prior notice submission. They take into account
different modes of transportation. The regulations require prior notice
at least two hours in advance of arrival by land via road, at least
four hours in advance of arrival by air or land via rail, and at least
eight hours in advance of arrival by water. The staggered prior notice
submission timeframes allow FDA reviewers to expedite their review of
shipments with shorter transport times without negatively affecting the
review times of shipments with longer transport times.
FDA and CBP are committed to further increasing integration of our
agencies' respective advance notice requirements with a goal of: (1)
achieving a uniform, integrated system; (2) building on current
operational procedures; and (3) implementing the law with minimal
disruption to current entry practices. Toward this goal, on April 4,
2004, FDA and CBP issued a plan, ``Joint FDA-CBP Plan for Increasing
Integration and Assessing the Coordination of Prior Notice
Timeframes.'' The plan describes the process by which FDA and CBP
intend to increase integration and examine whether we could amend the
timeframe requirements in FDA's prior notice interim final rule to be
the same as those in CBP's advance electronic information rule. The
plan was issued with an initial 30-day comment period, which FDA has
extended for an additional 60-day period that ends July 13, 2004.
Although the interim final rules became effective December 12,
2003, FDA and CBP issued a Compliance Policy Guide that explains our
intention to focus initially on educating affected firms and
individuals about the new prior notice requirement while gradually
phasing in enforcement of the prior notice interim final rule. This
phase-in period will end August 12, 2004, at which time full
enforcement will begin.
While we cannot physically inspect every shipment, it is important
to note that every shipment that contains FDA-regulated products that
is entered for consumption or warehouse storage through CBP's ACS is
electronically reviewed by FDA's Operational and Administrative System
for Import Support to determine if the shipment meets identified
criteria for physical examination or sampling and analysis or warrants
other review by FDA personnel. This electronic screening allows FDA to
concentrate its limited inspection resources on high-risk shipments
while allowing low-risk shipments to proceed into commerce.
With the new prior notice requirement, specific information
mandated by the Bioterrorism Act must be submitted to FDA before the
imported food arrives in the U.S. This not only allows the electronic
system to review and screen the shipments for potential serious threats
to health (intentional or otherwise) before food arrives in the U.S.,
but it also allows FDA staff to review prior notices of those products
flagged by the systems as presenting the most significant risk and
determine whether the shipment should be held for further
investigation. FDA worked very closely with CBP in developing this
screening system.
In addition, FDA has been actively working with the analysts at
CBP's National Targeting Center to utilize their Automated Targeting
System as an additional tool to enhance the Agency's ability to focus
attention on those imported foods that may pose a serious threat to
public health. We anticipate that the use of FDA's and CBP's screening
systems will enable both agencies to effectively target shipments
posing the greatest risk in order to further focus our border
inspection efforts.
In developing the interim final rules to implement the registration
and prior notice requirements, FDA carefully considered all the
comments received during the public comment periods and strived to
develop provisions that were consistent with the Bioterrorism Act and
that achieve its objectives while minimizing the impact on trade to the
extent feasible. FDA and CBP have conducted extensive domestic and
foreign outreach to explain the rules to consumers and the food
industry. FDA has been commended by numerous parties throughout the
world for what many describe as an unprecedented level of outreach.
Administrative Detention
Section 303 of the Bioterrorism Act gives FDA new authority to
administratively detain any article of food for which the Agency has
credible evidence or information that the food presents a threat of
serious adverse health consequences or death to humans or animals. This
authority is self-executing and provides an added measure to ensure the
safety of the nation's food supply. Section 303 also requires FDA to
provide by regulation procedures for instituting on an expedited basis
certain enforcement actions against perishable foods subject to a
detention order. On June 4, 2004, FDA published a final rule to
implement this section. The rule includes procedures for detaining an
article of food, expedited procedures for detaining perishable foods,
and the process for appealing a detention order.
Maintenance and Inspection of Records for Foods
Section 306 of the Bioterrorism Act authorizes FDA to have access
to certain records when the Agency has a reasonable belief that an
article of food is adulterated and presents a threat of serious adverse
health consequences or death to humans or animals. It authorizes the
Secretary to publish regulations to establish requirements regarding
the establishment and maintenance, for not longer than two years, of
records by persons (excluding farms and restaurants) who manufacture,
process, pack, transport, distribute, receive, hold, or import food. On
May 9, 2003, FDA published a proposed rule to implement this section.
We have received approximately 200 comment letters that we have
carefully considered. We intend to issue a final rule in the near
future. When finalized, the recordkeeping regulation will enhance FDA's
ability to track and contain foods that pose a threat of serious
adverse health consequences or death to American consumers from
accidental or deliberate contamination of food.
Authority to Commission Other Federal Officials to Conduct Inspections
Section 314 of the Bioterrorism Act authorizes the Secretary to
commission other Federal officers and employees to conduct examinations
and investigations. Pursuant to this new authority, FDA and CBP have
signed a Memorandum of Understanding to commission CBP officers to
conduct examinations on FDA's behalf at ports where FDA may not
currently have staff or to augment FDA staff in the enforcement of
FDA's prior notice requirements. This unprecedented FDA-CBP
collaboration significantly strengthens our ability to secure the
border while ensuring the movement of legitimate trade. In accordance
with this new authority, FDA has already commissioned over 8,150 CBP
officers. The Agency will continue to explore use of this authority
with other agencies as a tool to further improve efficiencies.
Authority to Mark Articles Refused Admission into U.S.
Section 308 authorizes the Secretary to require the marking of
refused food (other than food required to be destroyed). This provision
is intended to prevent unsafe foods that have been refused entry into
the U.S. from entering U.S. markets via the practice of ``port
shopping.'' This is a practice by which importers send goods that have
been refused entry at one port to a different port in the hope of
obtaining admission for the refused goods. Obviously, this practice
puts American consumers at risk. Before passage of the Bioterrorism
Act, FDA had published a proposed rule to require the marking of
refused food. This proposal was withdrawn in light of the new and
additional statutory requirements. We are considering a new rulemaking
to implement Section 308.
Protection Against Adulteration of Food
Section 302 of the Bioterrorism Act contains numerous provisions
intended to increase protection against adulteration of food. One of
the requirements in this section is for the Secretary to give high
priority to increasing the number of inspections of food offered for
import. Thanks to a fiscal year 2002 supplemental appropriation, FDA
received counterterrorism funds that enabled us to hire additional
staff, most of whom were hired to address food safety issues, primarily
at the border. With these additional employees, we have more than
doubled the number of ports that have an FDA presence from 40 to 90
ports. We have increased by more than six-fold the number of food
examinations at the border.
In compliance with another requirement in this section, on October
16, 2003, we submitted a report to Congress, ``Testing for Rapid
Detection of Adulteration of Food,'' about the research that is
underway to develop tests and sampling methodologies to rapidly detect
adulterated food. FDA has commenced more than 90 different research
projects to develop tests and sampling methodologies to increase the
detection of adulterated food. A number of the research projects are
designed specifically to develop tests suitable for inspections of
foods at ports of entry. For example, commercially available test kits
are currently being analyzed for a variety of food matrices to evaluate
their suitability for use in the field at ports of entry. We are in the
process of preparing the second annual report on our research
activities.
Also pursuant to a requirement in Section 302, HHS provided a
report to Congress on assessments of the threat of the intentional
adulteration of food.
CONCLUSION
In conclusion, thanks to the new authorities provided by the
Bioterrorism Act along with HHS' other food safety activities, the
nation's food safety system is stronger than ever before. As you might
imagine, it has been a tremendous undertaking for FDA to implement the
provisions in the Bioterrorism Act in such a short period of time. We
are proud of our accomplishments and will continue our efforts to
implement the Bioterrorism Act in an efficient and effective manner. We
are thankful to Congress for these new authorities that will serve to
bolster the safety of our food supply.
In addition to the new authorities provided to us in the
Bioterrorism Act, I would like to briefly mention some other activities
in which FDA has been involved to ensure the safety and security of our
nation's food supply. We have enhanced coordination with our partners
in Federal, state, and local governments, academia, and industry. To
minimize the risk that food will be subject to tampering or other
malicious actions, we have issued guidance for the food industry on the
security measures it may take. We are also working with DHS to carry
out our Sector-Specific Agency responsibilities under Homeland Security
Presidential Directive 7/Critical Infrastructure Identification,
Prioritization, and Protection for food other than meat, poultry, and
egg products. FDA has embarked on an ambitious research agenda
throughout the Agency to address potential terrorist threats. To
increase laboratory surge capacity, FDA has worked closely with CDC and
USDA to expand the Laboratory Response Network by establishing the Food
Emergency Response Network. Through this aggressive and collaborative
program, FDA has made significant progress in strengthening the safety
and security of the nation's food supply.
Thank you for this opportunity to discuss our efforts to implement
the food safety provisions of the Bioterrorism Act. I look forward to
continuing to work with you and would be pleased to respond to any
questions.
Mr. Bilirakis. Thank you, Dr. Crawford. And I did not
intend to speed up your testimony there.
Ms. Sauceda.
STATEMENT OF CATHY SAUCEDA
Ms. Sauceda. Yes, sir. Good morning. Thank you, sir. Good
morning, Mr. Chairman, other members of the subcommittee. I am
Cathy Sauceda, and I am the Director of Special Enforcement
with Customs and Border Protection, the Department of Homeland
Security. I am pleased to be here with Dr. Crawford, Acting
Commissioner of the Food and Drug Administration.
I want to thank you for this opportunity to discuss Customs
and Border Protection's actions to implement the food safety
provisions of the PublicHealth Security and Bioterrorism
Preparedness Act of 2002, or what we call the Bioterrorism Act.
This legislation presented a significant opportunity to
enhance protection of our imported food supply chain against
the threat of intentional contamination and other food-related
emergencies while challenging us to facilitate the movement of
legitimate goods. Meeting this balance between safety and
facilitation has been a top goal for Customs and Border
Protection.
In my testimony today, I will first provide some background
on Customs and Border Protection's responsibilities, and then
describe some of the key actions that CBP has taken to
implement the food safety provisions of the act and ensure that
legitimate trade is facilitated.
The primary mission of Customs and Border Protection is
detecting and preventing terrorists and terrorist weapons
entering the United States. As the single border security
agency, Customs and Border Protection has twin goals: To secure
America's borders while facilitating the flow of legitimate
trade and travel.
With respect to the Bioterrorism Act, CBP has worked in
concert with the Food and Drug Administration to detect and
intercept violator shipments by providing personnel with
experience in targeting and CBP officers to perform BTA-related
work in over 300 ports of entry.
Joint targeting and training in our automated targeting
system and use of our automated commercial system to meet the
regulatory submission requirements for the prior notice that
was required under the act has been undertaken. Use of our
automated broker interface as part of our automated commercial
system allows the trade to meet timely prior notice
requirements without having to enter prior notice data into two
different systems, which would be the Food and Drug
Administration's PNSI system and CBP's ACS. Using ACS also
ensured that these new requirements would be less likely to
disrupt the flow of trade.
As part of the joint targeting, Customs and Border
Protection and FDA are collocated at CBP's National Targeting
Center, where FDA has established their Prior Notice Center. A
jointly developed scoring rule set for FDA which enables them
to use CBP's automated targeting system has been developed and
is being continuously refined. By working together to define
and determine risk, FDA can more readily identify anomalies in
food importations and concentrate efforts in areas of high
risk.
Cooperative agency efforts also allow CBP and FDA to
perform joint targeting so goods will not be inspected twice,
once for FDA and once for CBP, for terrorism.
In addition, we have worked, as Dr. Crawford says, with the
FDA to commission some 8,000 Customs and Border Protection
officers to take action on behalf of FDA in a 24 by 7 mode.
This commissioning allows FDA to assert a 24 by 7 presence to
enforce the act at all ports when FDA staffing is either
limited or nonexistent. This 24 by 7 presence at all ports
allowed FDA to lessen the prior notice timeframe stated in the
notice of proposed rulemaking to 8 hours by vessel, 4 hours by
air and rail, and 2 hours by truck, which is listed in the
interim final rule.
Recognizing the impact on the trade and the possibility of
having ports literally closed due to the failure to comply with
this legislation, Customs and Border Protection has worked
diligently with the Food and Drug Administration and
independently on outreach programs both domestically and
internally. We trained our Customs and Border Protection
attaches, and we, independently and with FDA, went to Europe,
South America, Central America, and Mexico to conduct outreach
to train our customers. Special care has been taken to ensure
that our immediate neighbors, Canada and Mexico, have been
included in the training and operational discussions,
addressing their concerns to the extent possible, while still
remaining in compliance with the law.
Our efforts to ensure that legitimate trade would not be
compromised led us in cooperation with FDA to apply a phased-in
approach to enforcement. This phased-in approach started on
December 12, the date of the implementation of the act, 2003,
and is progressing through four phases that started with
informed compliance and is moving toward full enforcement on
August 13.
We are currently in phase three of the enforcement plan.
For the first time, in phase three, shipments were refused for
failure to file prior notice. Despite this, there has been very
minimal disruption in the trade as our efforts in outreach have
been successful. Only 2,479 shipments have been found to be not
in compliance since June 4.
During the phased-in approach, we have continued our
outreach in addition to jointly issuing the compliance guide
explaining the four phases of increasing enforcement and
possible consequences of noncompliance. As we move closer to
full enforcement, we will continue to refine procedures,
identify, and correct systemic or logical problems, and address
legitimate trade concerns with compliance of the act. We will
continue to work with FDA in improving their target ability and
to coordinate timeframes with those listed in CBP's advanced
electronic role.
I would like to thank you for this opportunity to discuss
our efforts and implementation of the food safety provisions of
the Bioterrorism Act. I looked forward to continuing to work
with you, and would be pleased to respond to any questions.
[The prepared statement of Cathy Sauceda follows:]
Prepared Statement of Cathy Sauceda, Director, Special Enforcement,
Customs and Border Protection
Good morning, Chairman Bilirakis and Members of the Subcommittee. I
am Cathy Sauceda, Director of Special Enforcement, Customs and Border
Protection (CBP), which is part of the Department of Homeland Security
(DHS). I am pleased to be here today with Dr. Lester M. Crawford,
D.V.M., PH.D., Acting Commissioner of the FDA.
Thank you for this opportunity to discuss CBP's actions to
implement the food safety provisions in Title III, Subtitle A--
Protection of Food Supply--included in the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act).
This legislation presented a significant opportunity to enhance
protection of our imported food supply chain against the threat of
intentional contamination and other food-related emergencies, while
challenging us to facilitate the movement of legitimate goods without
causing undue delays and economic hardship. Meeting this balance
between safety and trade has been a top priority for CBP.
In my testimony today, I will first provide some background on
CBP's responsibilities. Then, I will describe the many actions taken by
CBP to implement the food safety provisions of the Act and ensure the
facilitation of legitimate trade.
The primary mission of Customs and Border Protection is detecting
and preventing terrorists and terrorist weapons from entering the
United States. As the single border security agency, CBP has twin
goals: to secure America's borders while facilitating the flow of
legitimate trade and travel. With respect to the Bioterrorism Act, CBP
has worked in concert with FDA to detect and intercept violative
shipments by providing personnel with expertise in targeting and CBP
officers to perform BTA related work at more than 300 ports of entry.
Joint targeting and training in the use of our Automated Targeting
System (ATS), and use of our Automated Commercial System (ACS) to meet
the regulatory submission requirements for Prior Notice as required
under the Act was undertaken. Use of our Automated Broker Interface
(ABI), a part of ACS, allows the trade to timely meet the Prior notice
requirements without having to enter Prior Notice information into two
electronic systems (FDA's PNSI and CBP's ACS). Using ACS also ensured
that these new requirements would be less likely to disrupt the flow of
legitimate trade. We have jointly enhanced both of our systems, ACS and
OASIS, the FDA automated system, to accommodate the new user
requirements as required to meet the statute.
As part of the joint targeting, CBP and FDA are co-located at CBP's
National Targeting Center, where FDA has established their Prior Notice
Center. A jointly developed scoring rule set for FDA which enables them
to use CBP's Automated Targeting System has been developed and is
continuously being refined. By working together to define and determine
the risk, FDA can more readily identify anomalies in food importations
and concentrate resources in areas of risk. Cooperative agency efforts
also allows CBP and FDA to perform joint targeting so goods will not be
inspected twice--once for each agency for the purpose of prevention of
terrorism.
In addition, we have worked with FDA to Commission over 8,000 CBP
officers to take action on behalf of the FDA under the Act. This
commissioning allows FDA to assert a 24 X 7 presence to enforce the Act
at all ports, even when FDA staffing is limited or non-existent. This
24 X 7 presence at all ports allowed FDA to lessen the Prior Notice
timeframes stated in the Notice of Proposed Rulemaking to 8 hours by
vessel, 4 hours by air or rail and 2 hours by truck as stated in the
Interim Final Rule.
Recognizing the impact on the trade and the possibility of having
ports literally closed due to failure to comply with this legislation,
CBP has worked diligently both with the FDA and independently on an
outreach program, both domestically and internationally. We trained CBP
attaches as to the requirements of the Act, which allowed them to
conduct training in their respective foreign countries. These sessions
supplemented additional presentations that were given by CBP to
governmental and trade associations throughout Europe, Asia, and South
America. Special care has been taken to ensure that our immediate
neighbors, Canada and Mexico, have been included in the training and
operational discussions, addressing their concerns to the extent
possible while still complying with the law. Presentations have been
given to various domestic trade organizations such as the Pacific Coast
Counsel, who is also here to speak, and we have formed a joint task
force with the National Customs and Brokers Association (NCBFAA), who
are also in attendance.
Our efforts to ensure that legitimate trade would not be
compromised led us, in cooperation with the FDA, to apply a ``phased
in'' approach to enforcement. This phased in enforcement started on
December 12, 2003 (the implementation date required under the
Bioterrorism Act) and is progressing through four phases that started
with informed compliance and is moving towards full enforcement on
August 13, 2004.
We are currently in Phase III of the enforcement plan. For the
first time, shipments were refused for failure to file Prior Notice.
Despite this, there has been minimal disruption in trade as our efforts
in outreach programs were rewarded.
During the phased in approach we have continued our outreach,
publishing pamphlets in English, Spanish and French for the traveling
public, jointly issuing a Compliance Guide explaining the four phases
of increasing enforcement and the possible consequences for failing to
meet the requirements under the statute. In addition, we have issued an
internal and public version of mitigation guidelines for the issuance
of penalties.
As we move closer to full enforcement we will continue to refine
procedures, identify and correct systemic or logistical problems and
address legitimate trade concerns with regard to the Act. We will
continue to work with the FDA in improving their targeting ability so
as to coordinate its timeframes with those in CBP's Advance Electronic
Rule. This will lead to more accurate targeting of possible high threat
shipments, thus ensuring the safety of imported food while
simultaneously not acting as a barrier to trade.
Thank you for this opportunity to discuss our efforts to implement
the food safety provisions of the Bioterrorism Act. I look forward to
continuing to work with you and would be pleased to respond to any
questions.
Mr. Bilirakis. Thank you very much, Ms. Sauceda. I will
start off the questioning. There is a long list of questions,
and as per usual we submit them to our witnesses and then they
respond in writing. So we would hope you would do that in a
timely fashion.
I am just going to focus on one. Ms. Sauceda and Dr.
Crawford, take us to the border--to a border. There are a
number of means whereby manufacturers, researchers, plain
people, ships bringing in, you know, containers, et cetera, et
cetera, bring in food to this country. Take a couple of those
of your choosing, and explain to us exactly what happens, sort
of a step-by-step process in terms of how you coordinate with
FDA. You know, the interaction--apparently both of you have
indicated that the interaction of your two agencies works well,
and I am very happy to hear that. We don't always get that
information. But sort of take us through something like a--pick
an illustration, if you will, and take us through step by step.
Ms. Sauceda. Speaking on our land border, which is my main
area of expertise, now with the filing of prior notice, FDA
becomes aware, as does Customs and Border Protection, in
advance of the arrival of the shipment of the goods. If those
goods are determined to be suspicious, then those goods are
actually held at the border location, they are not allowed to
proceed. Both FDA and CBP will become aware at the same time
that these are violated goods that will be held. The
determination is made jointly by Customs and Border Protection
and FDA at a Customs headquarters office here in Washington
where they are collocated.
Mr. Bilirakis. Excuse me. You know in advance that these
goods are coming?
Ms. Sauceda. Yes.
Mr. Bilirakis. Might there be any instances of that type of
volume where you would not know in advance?
Ms. Sauceda. No. Under the prior notice rule, we will have
the--the only way we would not know in advance is if someone
tried to make an entry without following the proper paperwork.
But assuming they are in compliance, we would know in advance.
Jointly, we determine that we will inspect the goods. Jointly,
we, CBP, look to see if we have a need to inspect while at the
same time FDA has a need to inspect. We contact the ports of
entry so that they are very aware, they are aware the goods are
coming, and we--both agencies meet these goods as they arrive
at the location and we do our inspections. That could also
include the Customs inspections for x-rays, dogs, any other
type of activity. And we both clear the goods, one examination,
and then we would allow the goods to proceed. Or, if we needed
to send it to some kind of a facility for examination, under
the Bioterrorism Act of course it has to go to a secure
facility and can't go to the owners or importers' premises. But
FDA and CBP know the whole time what is happening to the goods,
and we know when the goods are in compliance and when the goods
are allowed to be released.
Mr. Bilirakis. All right. Now, under what type of instances
might you be sort of suspicious at the outset and feel that a
better examination is required? Would it be based on the
particular organization that is bringing the goods in or their
history, that sort of thing? Where they maybe have initiated
from?
Ms. Sauceda. Prior to December 12, the actual
implementation, CBP and FDA took their best and brightest
targeters and all the intelligence that we had through FDA's
system and through our intelligence and our system, including
what we know of importers, what we know of suspicious
countries, and all the types of items that go together to
confirm a risk. And we put all of that into what we call a rule
set. And when those criteria come up in a shipment, maybe it is
a first-time importer, maybe it is--we have always had problems
with bottled water from Turkey, for example. The system sees
that and kicks it out and says, wait a minute, this is a
shipment that perhaps we need to look at.
And then, of course, there is always human intervention;
that we see something, it doesn't look right, and then we go
ahead and target it for examination.
Mr. Bilirakis. I am sorry, Dr. Crawford. Did you have
something you wanted to add?
Mr. Crawford. Just that we also from time to time, as Ms.
Sauceda well knows, receive tips or information that it is
given to us, and we consider those also.
Mr. Bilirakis. All right. Now, you know, in coming in, I
guess maybe we have all made mistakes from overseas trips
bringing in, oh, I don't know, maybe some figs or an apple or
something of that nature. And obviously, if you report that, it
is confiscated. And that was done for reasons other than
concerns of terrorism and what not, obviously, in those days.
Has that slacked off a little bit because of more emphasis
being put into homeland security, if you will?
Ms. Sauceda. The emphasis of just taking goods from
passengers?
Mr. Bilirakis. Routine, yeah. The routine check for foods
coming in, which was for health purposes and what not.
Ms. Sauceda. The Department of Agriculture is still very
much involved, and they regulate many of the items that come
in. The Bioterrorism Act is not concerned necessarily with
personal shipments brought in by the traveler. But still, if a
passenger brings in a mango or brings in some kind of food that
is prohibited by them, they would still be asked to abandon the
goods or I guess return them back to the country of export.
Mr. Bilirakis. But your resources have not been shifted to
any large degree from the one to the other, to put more
emphasis on the homeland security, as far as you know?
Ms. Sauceda. Well, generally, in these locations the
parties that are detecting this are the same parties that are
clearing them from Immigration. So they are really doing multi-
functions on this passenger at the same time.
Mr. Bilirakis. Thank you.
Dr. Crawford, anything you wanted to add?
Mr. Crawford. No. The Animal and Plant Health Inspection
Service continues, and I believe their strength has actually
even increased some. I do not know whether the confiscation of
things like sausages and whatever that are brought in has
increased or decreased. But we can communicate with them and
get that for the record, if you would like.
Mr. Bilirakis. No, that is okay. I think you would know.
Mr. Brown to inquire.
Mr. Brown. Dr. Crawford, the prior notice requirement took
effect last December. And even though you won't be enforcing
them--my understanding--enforcing the requirement for another
couple of months, you I would guess have some idea after 6
months of operation as to how it is going. And I would like, if
possible--I don't expect answers to this today, but if in
writing you could get us some statistics on how the program is
working.
Mr. Crawford. We will.
Mr. Brown. Okay. Thank you. How many shipments reach ports
of entry without prior notice, how many prior notice
submissions have simple clerical errors that could result in a
shipment being turned back, how many are prior notice
submissions complete except for the manufacturer's registration
number, and how these and other numbers have changed, if folks
have gotten used to the new system? If you could get us that.
Mr. Crawford. Absolutely.
[The following was received for the record:]
Q: How many shipments reach ports of entry without prior notice?
A: A recent review of entry data from Customs and Border
Protection's Automated Commercial System (ACS) during the week of June
27 through July 3 shows that prior notice was not submitted for 625
food items. This represents less than 0.5% of a total of 128,829 food
items entered through ACS for which prior notice should have been
submitted.
Q: How many prior notice submissions have simple clerical errors
that could result in a shipment being turned back?
A: At the present time, we are operating in a period of enforcement
discretion in which shipments are generally not being refused for
failure to submit a complete and accurate prior notice. Thus, FDA has
not been turning back shipments due to simple clerical errors. After
this transition period, submitters will have the opportunity to correct
faulty data submissions, including those resulting from clerical
errors, because both the ACS and FDA's Prior Notice System Interface
will not accept a submission until all required fields are completed.
If, however, a shipment is refused because of inaccurate prior notice,
the person may resubmit the prior notice instead of exporting the
shipment.
Q: How many prior notice submissions are complete except for the
manufacturer's registration number?
A: Based on a snapshot of activity in July, approximately 13% of
prior notice submissions in ACS contain no registration information
(i.e., name, address, and registration number associated with the
article of food) and approximately 3% contain a registration number
that is not on file at FDA.
Q: How have these and other numbers changed as folks have gotten
used to the new system?
A: The percentage of shipments entered through ACS that contain all
the required data fields has increased from 49% in January to 78% in
July. We expect the completeness of the prior notice submissions to
continue to improve as people gain experience with the system and as we
near the period of increased enforcement.
Mr. Brown. I want to shift gears slightly, and I know the
substance of this hearing and I appreciate your being here. And
I am troubled by the--and this was not really on your watch,
although it is beginning to be--troubled by the increased
politicization of what I think once was the finest, perhaps the
finest agency in the Federal Government. And it started 2 or 3
years ago, when I remember in this subcommittee and in a
meeting prior to that--and, again, this is not your fault or
under your watch. But the FDA, top people at the FDA came in,
and in a presentation to us about safety, about what I thought
was about the FDA's major charge, safety, protecting the
public, talked about their pride--in leading off their
presentation, their pride in the fact that the U.S. drug
industry now has a higher percentage of the world market than
ever before, how we were going to together increase that. Which
is a good thing, but not the charge of the FDA.
And now I am further troubled by two other more recent
events. One is during the reimportation legislation the fact
that the FDA actually lobbied Members of Congress--which I
thought was illegal; it is certainly untoward--and then now the
sort of continued scare tactic FDA is putting out to the
American public that drugs from Canada are or could be
potentially contaminated, as if there are new stories in the
front page of the French, French and Germans and Japanese and
Israelis and Canadians dropping dead on the streets from
contaminated drugs. You know, we are safely importing food for
Yemen and Iran and places that State Department says that
clearly are more troubling places, and yet we can't seem to
safely--the FDA, some of your spokespeople seem to say we can't
safely import prescription drugs from Canada.
My question is that, rhetorical and otherwise.
And also, I would like--if the FDA is going to continue to
say these drugs aren't safe, if you would begin to give us some
names of people who have been harmed by contaminated drugs. I
do know that Jeffrey Truitt, the FDA--not the FDA; sometimes I
get them mixed up too often anymore--PhRMA's--I apologize for
that, bit of a cheap shot, but unfortunately there seems to be
more leaning that way in this agency. But PhRMA's top
spokesperson, made a statement to a paper in my hometown that
15 percent of drugs coming from--this is passed through a
reporter saying this. Either 15 percent of drugs imported from
Canada or imported overall were counterfeit, which is the term
he used, which is misleading, which I believe means not FDA
approved. But nonetheless.
can--but if these statements are going to keep coming from
the FDA, we would like to see real specific cases. Are there
any?
Mr. Crawford. We have very little in the way of adverse
reactions or deaths from Canada or any other country that
exports to the U.S.
Mr. Brown. Very little, or none?
Mr. Crawford. Very little. From time to time there is a
reaction of some sort or another. We also have reactions from
U.S. produced drugs. However, we can provide you what
information we have. But as you know, we are in the business of
preventing these kinds of events from taking place. And FDA is
required, as you also well know, by law to go and conduct
inspections at any plant that is going to be producing drugs
for the U.S. market, wherever it is. So obviously we have more
comfort with drugs that are produced and remain in the United
States. That is sort of natural.
And I would also say that we still have the pride in FDA. I
haven't--I have been at FDA four different times, but I mostly
in my career have been elsewhere. But as you know and as you
indicated, around the world and here in the United States this
is a very respected agency. We must maintain that integrity and
respect. And I appreciate your comments about that, and we will
provide what we have.
Mr. Brown. Thank you.
[The following was received for the record:]
Question (paraphrased): Is FDA aware of deaths resulting from the
importation of prescription drugs?
Answer: First, we want to emphasize that FDA is unable to ensure
the safety and effectiveness of drugs imported by individuals from
other countries. It is FDA's goal to prevent death or serious injury
from adverse reactions to marketed drugs to the greatest extent
possible, and we have not waited for deaths to occur before expressing
our strong concern about the importation of medications outside of the
regulatory system established by Congress in the Food, Drug, and
Cosmetic Act.
FDA remains concerned about the public health implications of
unapproved prescription drugs obtained from entities seeking to profit
by getting around U.S. legal standards for drug safety and
effectiveness. Many drugs shipped to U.S. consumers by foreign sellers
that are purported to be the same as FDA-approved prescription drugs
are, in fact, of unknown quality. Consumers are thus exposed to a
number of potential risks, such as expired, subpotent, contaminated or
counterfeit product, the wrong or a contraindicated product, an
incorrect dose, or medication unaccompanied by adequate directions for
use. The labeling of the drug may not be in English and therefore
important information regarding safe use and side effects may not be
available to the consumer.
These concerns are amplified by the experience with state programs
that facilitate access to Canadian prescription drugs. Recent research
by the state of Minnesota pointed out significant problems related to
purchasing non-FDA approved pharmaceuticals from Canadian pharmacies.
Minnesota State health officials observed Canadian pharmacies engaging
in problematic practices during a single, voluntary, pre-announced
``visit.'' The officials noted dozens of safety problems, such as:
1. Several pharmacies used unsupervised technicians, not trained
pharmacists, to enter medication orders and to try to clarify
prescription questions;
2. One pharmacy had its pharmacists review 100 new prescriptions or 300
refill prescriptions per hour, a volume so high as to make it
impossible to assure safety;
3. One pharmacy failed to label its products, instead it shipped the
labels unattached in the same shipping container, even to
patients who received multiple medications in one shipment; and
4. Drugs requiring refrigeration were being shipped un-refrigerated
with no evidence that the products would remain stable.
At least one of the Canadian pharmacies visited by Minnesota health
officials dispensed many drugs that apparently were not even of
Canadian origin, and many of the drugs were obtained from prescriptions
that had been written and rewritten across multiple Canadian provinces.
These types of systematic safety problems would generally be clear
regulatory violations that would not be tolerated under the
comprehensive system of Federal and state regulation of drug safety in
the U.S.
Similar problems have become evident in the operation of the state
of Wisconsin's Prescription Drug Resource Center. In reviewing the
reports submitted by the three Canadian pharmacies linked to the
Wisconsin website, the Pharmacy Society of Wisconsin has identified
serious breaches of the agreements under which the pharmacies
participate in the state program. The Society found that of the 765
prescriptions dispensed by the pharmacies, 316 (over 41%) violated the
state agreements. Specifically, 127 of the dispensed drugs were
products not approved by FDA or available in the U.S., while 189 of the
drugs were products not authorized by the state program. In six
instances, the pharmacies improperly sent drugs requiring refrigeration
through the mail. Additionally, one of the Canadian pharmacies advised
the state that it intended to obtain drugs from a European supplier,
even though that was specifically prohibited by its agreement.
Responding to these reports, the Wisconsin Department of Health and
Family Services sent letters to the three pharmacies on April 27, 2004
ordering them to cease these prohibited practices, however, these
problems have not abated. In reaction to these reports, the executive
director of the Wisconsin Pharmacy Society, the professional
association representing licensed pharmacy practitioners in the state,
concluded that ``no one in Wisconsin has any real idea what these
Canadian businesses are doing.''
Significant safety issues surfaced when representatives of New
Hampshire Governor Craig Benson visited the Canadian Internet pharmacy
known as CanadaDrugs.com, located in Winnipeg, Manitoba. The ``terms of
service'' for CanadaDrugs.com requires purchasers to agree that they
``will not be liable for damages arising from personal injury or
death'' from the use of drugs sold by the pharmacy. Under this
practice, the consumer has no recourse for injuries arising from the
use of drugs from this shipper. Additionally, the website allows
patients to send in their prescriptions by fax, when the practice is
illegal under the law in New Hampshire and other states.
FDA is generally unable to quantify adverse events from imported
prescription drugs for a number of reasons. First, the adverse event
reporting system in the U.S. is not geared towards distinguishing
between foreign or domestically obtained drugs. Second, there is a
natural reluctance on the part of patients or their representatives to
report adverse effects of drugs that were obtained outside of the
normal, legal channels.
While FDA has not attempted to quantify the number of deaths or
serious injuries resulting from imported prescription drugs, we are
keenly aware of testimony provided to as many as three Congressional
committees by numerous families who have suffered the loss of loved
ones as a result of taking prescription medications obtained through
the Internet or foreign sources.
Mr. Bilirakis. The Chair recognizes Mr. Shimkus.
Mr. Shimkus. Thank you, Mr. Chairman, and I appreciate my
colleague from Ohio's concerns. That is a current political and
policy debate. But I know that our Oversight and Investigations
Subcommittee has held hearings on that issue and I know Jim
Greenwood actually has bottles labeled as if it was in the
United States and stuff. And I kind of used some of that
oversight investigation in my discussion of that issue that we
are talking about. It is not just--it may be dilution of drug,
it may be not the proper instructions, it could be again,
dosage, labeling, and use and handling and other things that
may not be just the empirical aspects of the drugs. So--but it
is something that we need to continue to get a handle on.
I want to now follow up with a question on this prior
notice stuff that--and to you, Dr. Crawford, in the information
the person filing the prior notice has to supply includes
shipper and manufacturing details such as manufacturer's FDA
registration number. But there are many cases where this
information is not available. How will manufacturers and
research laboratories be able to submit prior notices to get
samples of food into the United States when that information
needed to file a prior notice cannot be obtained?
Mr. Crawford. Well, what we have tried to do with this
registration number is we have tried to link the registration
provisions of the act with the prior notice provisions. And one
thing that helps us a great deal in FDA is if there is a
registration number. Because if the number is there and we can
check very quickly to see if it is valid, electronically, then
we know that they are registered. If the number--if we didn't
use the numbering system or numerical system, we would be--we
would not have improved our surveillance at all because we
would be back into the old days of trying to look at what the
address in France, Germany, or wherever it was, and wondering
if they were people that we didn't need to check. And so we
would be detaining shipments that we did not need to detain,
and it would be time consuming and we might miss something
because of that. So this gives us efficiency and it also links
these two provisions together. But there are----
Mr. Shimkus. We understand that. I mean, that is the
presupposition of the question. So if they don't, then what are
we going to do about it? Or, I mean, are they not going to be
able to submit?
Mr. Crawford. There are people that, there is like a gray
market and there is also a market where people buy substances
from manufacturers and then ship them without the permission of
the manufacturer. And there is always this kind of trade going
on. We have been working with CBP to try to improve this
situation and make sure that we don't impede trade because of
this particular kind of circumstance. There are also goods that
are returned to the U.S. after they leave the U.S., and some of
these are foods that are sold at Costco and stuff like that. So
we may need to come back to the Congress with some suggestions
of our experience at some point and say to you that maybe we
need some help.
Mr. Shimkus. Let me briefly ask one more. There are
facilities exempted in the act and in the FDA's regulation from
registration. Should other types of facilities be exempted
also?
Mr. Crawford. Well, I think we would like to have a little
more experience with that. I think that Congress got it right.
However, in the practicality of policing the borders we may
come up with some new categories. And also, as you know, trade
changes all the time. Since 1994 and the World Trade
Organization treaty, food trade has increased about fivefold in
the United States, as I believe the chairman mentioned. So over
the years it could be that niches develop that aren't covered
and don't need to be covered, and then we can exempt them. We
are open-minded about that.
Mr. Shimkus. I think that the testimony is there is
estimated 400,000 facilities that need to be registered with
the agency. Have they in fact been registered. Why are so many
facilities not yet in compliance?
Mr. Crawford. We estimated, based on the best information
we had, that there would be around 400,000 that needed to
register. Not that many have registered so far. So it could be
that we overestimated the number of facilities. However, we are
continuing on our outreach program to help them register, and
we have a hotline that is open to help them.
Mr. Shimkus. Thank you.
Mr. Chairman, I think this speaks to the importance of this
hearing, and probably a need to return in the appropriate time
when some of these questions can be answered. I yield back.
Mr. Bilirakis. Well, we hear the bells ringing. We have got
a problem here. I was hoping we could finish up with this panel
before 10:30, because I know Dr. Crawford--again, he is willing
to stay if need be.
Bart, you have 8 minutes, according to the rules. Gene, you
have 5 minutes. If you plan to take virtually all of the time,
I guess the only thing I can do is break.
Mr. Stupak. I would probably take all of my time.
Mr. Bilirakis. Okay. Well, we have more than one vote,
apparently. So, forgive me, but I guess that is the only thing
we can do. All right. We will break until, I don't know what we
are talking about here, probably about 15, 20 minutes. Okay.
Assuming it is only two votes at the most.
[Brief recess.]
Mr. Bilirakis. Is Ms. Capps prepared to inquire at this
point in time?
Mrs. Capps. Thank you, Mr. Chairman. And I apologize, I was
on the floor during your testimony. But I do have some
questions that I was hoping I would could ask of FDA.
On page 9 of your testimony, you state that with the new
prior notice requirement, specific information mandated by the
Bioterrorism Act must be submitted to FDA before the imported
food arrives in the United States.
I wonder if you could be--list some specific information to
which you refer and provide citations to this statute.
Mr. Crawford. Yes. I can do that for the record; but let me
just summarize what we are looking for. That is, we are looking
to see whether or not they have registered with FDA, and that
would be manifest by a registration number. And then we are
also matching them with CBP toward a list to see whether or not
we have any information about the firm that might cause us to
be suspicious about it. And also, we are very interested, as
you would know, of the origin of the shipment. And we need also
at that point to know where it came from--not just where it was
manufactured, but where it came from and where it is going. It
is called ``one up and one back'' rule.
And then my experience in working with FDA off and on for
30 years is that if they don't know where it came from, they
don't know where it is going, then we don't need it.
Mrs. Capps. And this is an ongoing and well understood
policy?
Mr. Crawford. It is, yes, and we maintain a hotline for
shippers 24 hours a day, 7 days a week, which is called a prior
notice center. So they are well aware of how to communicate
with us. And it is working, I think, very well indeed.
Mrs. Capps. So you feel that there is great both knowledge
of the regulations and compliance with it?
Mr. Crawford. Yes.
Mrs. Capps. It is a smooth--it hasn't really--9/11 and all
of these implementations have not really delayed or caused
serious problems?
Mr. Crawford. Correct. What some people were worried about
was long backups at the border, and we have not had that,
absolutely have not had that.
Mrs. Capps. That is good. Whether or not there was a 9/11,
that is good information to have.
If I could turn to section 307 of the act, which
establishes the prior notice of the--and in doing so lists
several items that the notice must contain. It doesn't mention
or require that the registration numbers specified in section
305 for food facilities be required in the prior notification.
And I will go on and then you can comment any way you would
like. It appears to be the case that the interim final rule on
prior notification requires a registration number because FDA
believes it is helpful to achieve the purpose of the act and it
is not being required because the statute says so. Am I
understanding this correctly?
Mr. Crawford. You are correct. That statute does not call
for a registration number. We believe it--well, we know that it
is useful to us.
Mrs. Capps. A registration number?
Mr. Crawford. Yes, because that is really the only way we
know that they have registered, unless we take their address
and so forth and check it, and that might cause backups at the
border. So we think it is an efficient way to do business, but
it is not called for by the statute.
Mrs. Capps. So do you think it should be?
Mr. Crawford. I think it is a tool that we cannot do
without and do our job, and that is up for the Congress to
decide.
Mrs. Capps. Well, that is why this hearing is going on, and
I certainly would hope that you feel that that is a good reason
for you to be here so that you can let us know. How do you know
something works until you try it for a while?
Mr. Crawford. Absolutely.
Mrs. Capps. And this is one area, it wouldn't be hard to
require it, right?
Mr. Crawford. No, it would not be.
Mrs. Capps. So that is one thing I am taking note of.
Mr. Crawford. Thank you.
Mrs. Capps. Maybe just try to do one more since I have
another minute.
In some of the testimony that will be presented for the
second panel, there is an indication that FDA needs to step
up--you need to step up your education efforts to be sure that
industry properly understands what constitutes prior
notification. It didn't sound like that was a need from you.
But if we are going to be hearing that in the second panel, I
would like to give you a chance to respond. Some of this must
wait for a final rule, clearly, but can you tell us what you
are doing now and what you plan to do when this rule is final?
In other words, what can we anticipate?
Thank you.
Mr. Crawford. I have had the privilege of reading some of
that testimony, and assuming they stick to the testimony, I
think I can answer that.
Mrs. Capps. Thank you.
Mr. Crawford. I believe that what the witnesses are
probably calling for is a continuing education program, an
outreach program. Prior to the implementation of the rule, we
did considerable outreach in the United States. But also we
visited or had group regional meetings with 80 countries, and
these are the primary ones that ship food to the U.S. Those
were done outside of this country and also here. But the
temptation is, is that once it starts you might not need to do
that again. But that is wrong. FDA needs to continue its
outreach and its education programs on an ongoing basis. In the
past, as you know, with some of our food safety rules like
HACCP and the low acid canned foods and some things like that,
we have at some point delegated with FDA oversight to third-
party organizations to continue that. And I think that is now
beginning. We use organizations like the Food and Drug
Institute, National Food Processors Association, and others,
that we work carefully with. And I think, I think we must be
held accountable for continuing that. Whoever is sitting in my
position, it ought to continue.
Mrs. Capps. One quick thing. Is this a burden? I mean, do
you have staff for it? We all get a little lax sometimes, and
we think we have done our job and we move on and we find that
there are new players, and just as you have mentioned.
Mr. Crawford. We can do it. As you know, we have an
exquisitely balanced set of resources, is the nicest way to put
it. But we are committed to doing this, and we can get it done.
Mrs. Capps. Thank you.
Mr. Crawford. Thank you.
Mr. Bilirakis. Mr. Stupak for 8 minutes.
Mr. Stupak. Thank you, Mr. Chairman.
Dr. Crawford, since you have to go, let me try to get a
couple questions in before you have to leave here. Does the FDA
have a goal for the percentage of the import shipments it would
like to inspect?
Mr. Crawford. Actually, that is based on a risk assessment.
We have this computer program and we also have our people on
the ground now, and we have also commissioned CBP people. So
there is no percentage that we are striving toward. Some
shipments we are going to need to inspect more than others. It
is based on what our concerns are. Others would be less. So
there is no percentage that we are shooting for.
Mr. Stupak. Well, what is the actual percentage of
inspections you are doing then?
Mr. Crawford. Of food shipments?
Mr. Stupak. Yes, sir.
Mr. Crawford. Around 2 percent.
Mr. Stupak. So you are doing 2 percent. So is your goal 4
percent? 10 percent?
Mr. Crawford. We have no goal. It is based on the risk. And
if we believe that on a given day everything needs to be
inspected, then that would be 100 percent. And some days----
Mr. Stupak. How are you going to do it? If you are doing 2
percent, and if some day your goal is 100 percent, how are you
going to do it? You are going to use people all over the place,
which is impossible to do.
Mr. Crawford. We just slow them down, and we comb through
and we get extra help. We can--as you know, we have
commissioned CBP, and we also can commission other agencies.
Mr. Stupak. If you just slow them down, why don't you slow
them down now and do more than 2 percent of actual inspections?
Mr. Crawford. Because, based on risk assessments, we don't
believe that it is indicated that we do that. We don't think
the risk is there to do 100 percent.
Mr. Stupak. Risk from terrorism, or risk from human health?
Mr. Crawford. Both. We treat them the same. We believe that
if we are extremely concerned about terrorism, we will do a
better job of general food safety. And I think that has turned
out to be the case. And the bill, the act has helped us with
that to focus ourselves. So I think the two go hand in hand.
Mr. Stupak. Well, let us go to the act for a minute.
Because long-term, the rules, the final rules on facility
registration and prior notice narrow the definition of food to
exclude food contact materials such as packaging. While the
legal analysis is interesting, it omits any consideration, much
less discussion, of the basic purpose of the Bioterrorism Act,
which is to protect Americans from intentional food
contamination. Acts of terrorism certainly could be carried out
via tampering with the food contact materials which in turn
contaminate food that is consumed.
Given the act that the act is designed to address, can you
comment on whether you may reconsider this decision and go back
to the definition contained in the proposed regulation? My
question is not whether or not you can support a definition,
whether you should adopt it and given the purposes of the act.
Mr. Crawford. Well, we can provide for the record our
experiences and also an analysis of what we think the risks are
from food packaging materials. And----
Mr. Stupak. But isn't your experience basically none, zip,
zilch? You haven't had that concern until after 9/11. Are you
trying to tell me you have had material contact problems since
9/11?
Mr. Crawford. No.
Mr. Stupak. And you didn't have any prior to?
Mr. Crawford. No. We have had material contact problems
since FDA started.
Mr. Stupak. How much is that?
Mr. Crawford. The relative risk is very, very small. We can
give you an analysis based on decade by decade, something like
that. But it is very small indeed.
Mr. Stupak. Well, when you look at a shipment, do you look
for pesticide use?
Mr. Crawford. If there is a country that has a history of
pesticide concern.
Mr. Stupak. Let's say Mexico.
Mr. Crawford. We do a sampling of product that comes in
from Mexico on a random basis to check for pesticides.
Mr. Stupak. Do you hold that vehicle there then until that
inspection is done?
Mr. Crawford. No, we do not. We let them go.
Mr. Stupak. You let them go. Then how do you recall them
then?
Mr. Crawford. We have a record now, thanks to the
Bioterrorism Act, of where the product is going. We also have
it identified so we can issue a recall after the fact.
Mr. Stupak. When a shipment comes in, when a shipment comes
in and they say--and correct me if I am wrong. But if it is
coming up from Mexico and they are sending a number of trucks
up, do you inspect every one of those trucks containing that
shipment?
Mr. Crawford. We do not.
Mr. Stupak. And if there are six trucks, you might check
one out of six?
Mr. Crawford. It could be that many. Yeah. It depends on
what the risk analysis shows, I mean, what our concerns are at
that present time. We may check all six of them if we have
reason to do so.
Mr. Stupak. See, my concern, in Michigan we had the
outbreak there in 1997, just strawberries found to have 18.4
percent violation of illegal level of pesticides. If you are
only checking 2 percent, and we know strawberries have about 18
percent, we are not catching very many.
Mr. Crawford. Well, I think using the Bioterrorism Act and
making it work, we are going to get better and better at that
because we will know better about what we are doing. The key to
finding this is not, in my view, the percentage of tests that
you do, but the wisdom of the tests that you pull off. I mean,
you have to know what you are doing, and you can't test safety
into the food. But if you believe that the food is
contaminated, you should hold it up and test it and take
whatever action you need to take. Like, for instance, the green
onions that we just picked up from Mexico.
Mr. Stupak. Well, my concern, when you take a look at FDA
inspections, domestic and imports, have steadily decreased.
From 1981, you had 21,000 inspections. By 1996, you are down to
5,000. And you are telling me you are at 2,000 now. If those
inspections continue to go down but the threat level is up, you
have changed the definition that we had in the Bioterrorism Act
and you made it narrower, and you are telling me you are doing
2 percent but you can't give me what an ideal goal is, that is
based upon threat assessment. I guess I am really skeptical
that anything is going to change here.
Mr. Crawford. Well, the number of inspections actually is
12,000 now, and--but inspections again are not the way to do
it. For example, with the cantaloupe situation that you are
aware of, we decided that--you know, testing is not the only
thing we have at hand. But in the event of an outbreak, it is
not the thing we use. What we do is we require the detention
without physical examination. For example, every load of
cantaloupes that came in were detained. And we are doing
something similar now with onions because we are back in the
onion season from Mexico, and that is like a 100 percent hold
and evaluate.
Mr. Stupak. So this inspection, the quality of it would
depend upon what your inspectors feel may be the threat at the
time.
Mr. Crawford. The totality of what we have to use,
including laboratory analysis, testing and so forth.
Mr. Stupak. Let me go to Ms. Sauceda. You peaked my
interest when you said you are using experienced people. My
concern is, before you all merged together when they had the
big thing, Immigration and Border Patrol and others and
Customs, there is a thing called--other than full-time
employees. And these employees have some--at least 5 years,
some as much as 20 years working the border are being forced to
compete with permanent full-time CBP officer positions.
Shouldn't these people who have a lot of experience on a border
be given priority or preferential consideration for permanent
positions in your Agency?
Ms. Sauceda. Sir, I don't have an answer for you at this
time, but I would like to answer your question for the record.
Mr. Stupak. Let me ask you this then, last year, right
around labor day, you claim you ran out of money so you laid
people off at the ports. My State of Michigan, which borders
Canada, Port Huron, Detroit, Sault St. Marie, were all laid
off. What happens then to the inspections if you are laying
people off because you run out of money before the end of the
fiscal year?
Mr. Bilirakis. Very brief answer, although it is a very
significant question.
Ms. Sauceda. Sir, I will have to answer that question for
the record.
Mr. Bilirakis. Without objection, you will submit that
information.
Mr. Green, Dr. Crawford has to be gone by 11, to inquire
for 5 minutes.
Mr. Green. Thank you, Mr. Chairman.
I would like to ask my full statement be placed into the
record.
This question is for either witness. I have a district in
Houston and, in my opening statement, talked about how I have
both the Port of Houston and the Intercontinental Airport. And
we have both air cargo and a big container port.
And I know Congressman Stupak found out about 2 percent of
the imports are being inspected. That is basically close to
what our percentage is for containers. It is for general cargo.
And I have been there with my Border Patrol agents or formerly
Customs agents before. And the food safety imports are a
concern, and I know the statistics.
Who performs these inspections for the Border Patrol and
Customs? Is it actually Customs and Border Patrol agents that
perform the food safety inspections on the docks?
Ms. Sauceda. The actual personnel in many cases that are
located at the borders are CBP personnel which now include the
legacy Agriculture persons and legacy Customs personnel. And I
certainly don't want to misspeak here, but some 90 ports of
entry, there are additional Food and Drug representatives co-
located. So it is a very joint effort.
As far as inspections are conducted for the Bioterrorism
Act, part of the commissioning we have done is cross-training
on FDA, sampling, examination, invoice detections and anomalies
where we can inspect for FDA where they are not located. So we
do have a coordinated effort. But the principal party at the
border location is the combined unit of CBP officers, which
constitutes the legacy Immigration and the legacy CBP.
Mr. Green. Legacy USDA officers, I guess, for food
inspection?
Ms. Sauceda. That is legacy Agriculture.
Mr. Green. Dr. Crawford, do you have anything else to add
to that?
Mr. Crawford. I do not.
Mr. Green. Ms. Sauceda , we have been contacted by a number
of the former USDA workers at the Port of Houston who have been
moved to DHS and specifically Customs. And while port security
is certainly part of their job, these workers have been trained
specifically in plant, animal and food safety, and yet they
claim they are being asked to carry weapons and engage in port
security, which they haven't been trained for.
And it is unusual because, typically, every Texan wants to
carry a gun anyway, particularly legally. But there is a
problem. I am concerned that our ports may be secured by these
folks that, again, they are the legacy USDA employees without
the proper training for the protection, like carrying a
firearm. And second, these workers, if they are being diverted
sometimes, because I know in earlier days under INS, oftentimes
the naturalization side would lose folks because they had to do
the Border Patrol issue and not Customs at that time. And I
understand the need for cross-training.
I just want to make sure, one, they are trained--USDA
legacy officers are trained. But also, would they be diverted
from food safety inspections to do, you know, for example, our
container cargo that may not be food-inspection related? And if
you could comment on those developments.
Ms. Sauceda. Sir, I do know we have extensive training
undergoing, being undertaken. We have training for the new
agriculture inspector position and the one-face-at-the-border
training, which includes all of the cross-training. I am not an
expert in that area, so I will make sure we get an answer for
you for the record.
Mr. Green. Other question we have, industry has expressed
concerns about prior notice system and the different
requirements imposed by FDA and Customs. And while we
understand that it always takes time to iron out the details
when you have a new process that we have gone into the last
couple of years, that enforcement date is rapidly approaching.
Can you talk about the steps you have taken to harmonize the
two prior notice systems as compared to--you know, it would
have to be completed by August, I believe. I know it is both
agencies.
Ms. Sauceda. One of the most significant things that did
happen was between the proposed rule or the notice of proposed
rulemaking and the interim rule, where the timeframes went from
noon the day before the date of arrival in the February rule to
8 hours for vessel, 4 hours for air and rail and 2 hours for
truck. FDA published--and I am not certain of the exact date, I
believe it was in March--that discussed that we will be
analyzing the timeframes to try to be consistent with the
tradeout timeframes for us, which is 24 hours by vessel, 4 by
air, 2 by rail and 1 by truck. And we will begin that analysis
once we get a complete handle of the compliance of the act,
which will begin on August 13.
So I believe we fully anticipate FDA beginning August 13
trying to reduce the timeframes to the extent possible while
allowing FDA to complete their mission of being able to stop
violative shipments.
Mr. Crawford. We would share that analysis with the
committee and give a staff briefing if you would like.
Mr. Green. I think that would be helpful. I know my time is
over, and I have other questions, and we will submit those.
Mr. Bilirakis. I would say to the Members of the panel, we
have talked about possibly holding a gathering with these good
people, not a formal hearing, but sitting down around a table
where we could accomplish a lot more in a more informal way.
Dr. Crawford and Ms. Sauceda , thank you very much for
being here today. I am sorry with what our schedules are like
here, just kind of terrible, but not a good way to operate, but
thank you very much. We appreciate it. And please respond to
the questions that we have sent to you.
As the next panel comes forward I want to take this
opportunity to recognize a very important member of my staff,
and that is Jeremy Allen. I am sure that all of you know that
Jeremy is my health policy coordinator on the Energy and
Commerce Committee. He is leaving my office next week. That is
something that is one of the hazards up here. I guess the
Energy and Commerce Committee is a breeding ground or certainly
a training ground for people to better themselves downtown.
But I would like to take a moment to thank him for his
extraordinary work, both for me and for the committee. He has
worked for me off and on for the past 5 years. And during that
time, he has been instrumental in passing historic legislation
such as the Children's Health Act, the Organ Donation and
Recovery Improvement Act and, especially, more recently the
Medicare Prescription Drug Improvement Modernization Act. These
are better laws because of Jeremy's hard work.
I wish him all the best in his future endeavors, including
his wedding next month, and I know that he will be a great
success because he is hard-working, diligent, extremely
intelligent and really a fine, nice person.
So Jeremy, while your success is clearly my loss and this
committee's loss, we all wish you good luck. And we will miss
you.
Thank you for joining us in that.
The second panel consists of Mr. John Cady, President and
CEO of National Food Processors Association; Mr. Roger Clarke,
Williams and Clarke Company; Mr. David French, Senior Vice
President, Government Relations, for the International
Foodservice Distributors; Ms. Susan M. Stout, Vice President of
Federal Affairs, Grocery Manufacturers of America; and Mr. Dick
Saunders, Program Manager, Office of Dairy and Foods, VA
Department of Agriculture and Consumer Services--Virginia
Department of Agriculture and Consumer services.
Welcome.
As I am sure many of you know--most of you, if not all of
you--your written statement is a part of the record. We will
set the clock to 5 minutes, and, hopefully, you will be able to
stay within that timeframe.
STATEMENTS OF JOHN R. CADY, PRESIDENT AND CEO, NATIONAL FOOD
PROCESSORS ASSOCIATION; ROGER CLARKE, WILLIAMS AND CLARKE
COMPANY; DAVID FRENCH, SENIOR VICE PRESIDENT, GOVERNMENT
RELATIONS, INTERNATIONAL FOODSERVICE DISTRIBUTORS ASSOCIATION;
SUSAN M. STOUT, VICE PRESIDENT OF FEDERAL AFFAIRS, GROCERY
MANUFACTURERS OF AMERICA; AND R. DOUGLAS SAUNDERS, CHAIR,
ASSOCIATION OF FOOD AND DRUG OFFICIALS (AFDO) FOOD SECURITY
TASK FORCE, ACCOMPANIED BY BETSY WOODWARD, SPECIAL ADVISOR TO
THE AFDO BOARD OF DIRECTORS
Mr. Cady. Thank you, Mr. Chairman.
My name is John Cady, and I am President and Chief
Executive Officer of the National Food Processors Association.
We serve as the $500-billion food and beverage industry's voice
on scientific and public policy issues involving food safety,
food security, nutrition, technical and regulatory matters and
consumer affairs.
We supported the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002. And to assure broad
industry input on FDA regulatory proposals, we have provided
comments to the Food and Drug Administration on behalf of our
375 member companies as well as leading the food industry's
coalition in Bioterrorism Act regulations. FDA has adopted a
number of the industry's recommendations, so my comments today
focus on remaining industry concerns about FDA's rules for
registration of food facilities, prior notice of imported food
shipments and the establishment, maintenance and availability
of records.
FDA has reported that about half of approximately 400,000
domestic and foreign facilities subject to the registration
requirement have registered. This calls for more outreach in
the form of guidelines and clarifications from FDA to educate
the regulated industry about the registration requirements.
While FDA has clarified that certain facilities are exempt from
registration, such as private residences that hold food for
distribution to consumers, we believe additional facility
exemptions are warranted, including facilities that hold food
as an incidental part of their businesses.
FDA's December 2003 Compliance Policy Guide allows that,
under limited circumstances, unregistered facilities will have
the opportunity to come into compliance before enforcement
action is taken. This worthwhile enforcement policy fosters
industry awareness and compliance with the registration
requirement and should be maintained until greater overall
compliance is achieved.
The major problem posed by FDA's interim final rules for
prior notice of imported food shipments concerns the inability
of industry to import research and development samples into the
United States. Small quantities of food products are frequently
purchased at retail and foreign countries to evaluate against
comparable U.S. products or to determine the potential for
producing a similar product in the United States. Under the
rule, these research and development samples will not be
allowed into the United States because the purchaser has no
practical way of securing the registration number of the
foreign manufacturing facility, which FDA requires in the prior
notice. This is a requirement, by the way, that is not mandated
in the Bioterrorism Act.
This places U.S. companies at a competitive disadvantage
and encourages the relocation of research and development
activities to Canada, for example, where imported samples are
not restricted. NFPA urges FDA to just require the name and
address of the foreign manufacturer on the prior notice as in
the case when individuals in foreign countries send purchased
products to individuals, not companies, in the United States.
Another issue is the fact that FDA and Customs' prior
notice requirements differ. Full enforcement of FDA's prior
notice requirements will begin in mid-August this year before
FDA and Customs' requirements are harmonized. We have asked FDA
and Customs to accelerate these harmonization efforts.
While FDA's final rule on records has not been issued, I
want to highlight some issues raised in our comments on the
proposed rule. The proposed rule requires detailed information
for each lot of production made at the company. FDA does not
define a production lot. However, one definition is, all the
products marked with the same unique code which may reflect the
time and place of production and character of the food. The
size and composition of production lots vary based on
particular processes, operations and needs of each food
company. While lot coding is widely used by the industry, it is
not mandated for all products.
Our concern is that FDA's proposed lot-level recordkeeping
poses serious technical and operational problems for
collecting, maintaining and tracking the detailed information
FDA is seeking. For example, as products are distributed, it is
not possible, in many instances, to keep track of exact lot
codes of the products that go to an individual store or to
customers. Once in the distribution system, it cannot be
guaranteed that a given lot of production will stay together or
even the shipments of like food products will be from the same
production lot. Also, the ability to precisely identify the
sources of each ingredient that go into a given lot cannot be
guaranteed.
It is our understanding that retail inventory and stocking
records do not rely on production lot codes. Today, product
recalls normally involve removal of all potential affected
products rather than selective removal based on product lot
codes. NFPA has urged FDA to abandon the requirement for lot-
level information and records.
As FDA has acknowledged, the Agency understands that
companies may only be able to identify a subset of all possible
ingredient sources rather than a specific source. This FDA
acknowledgment embodied in the proposed regulation should
become a requirement and be applied to all ingredients and
products. FDA's proposal would also require companies to
produce documentation to identify the sources and recipients of
food ingredients of products within 4 hours of an FDA request
during a work week and within 8 hours of a request on weekends
or holidays.
NFPA has suggested that FDA's review and interpretation of
documentation should not be the criteria for taking needed
action to address a terrorism incident. We have suggested that
24 hours is a more appropriate timeframe for producing
documentation. Rather it is the immediate action by FDA on the
incident that should occur. The paper review can come later.
In conclusion, I want to acknowledge FDA's efforts in
seeking the industry's input in developing these regulations
and the Agency's willingness to incorporate suggestions to
strengthen and improve the new requirements.
However, as an industry, we do have the concerns that I
have covered today. There is the need for FDA to address these
issues in a timely way in order to achieve industry and FDA's
common goal of reaching full compliance as soon as possible.
Thank you, sir for the opportunity to comment on this
important subject.
[The prepared statement of John R. Cady follows:]
Prepared Statement of John R. Cady, President and CEO, National Food
Processors Association
Mr. Chairman, my name is John Cady, and I am President and Chief
Executive Officer of the National Food Processors Association. NFPA is
the largest trade association representing the food and beverage
industry in the United States and worldwide, serving as the industry's
voice on scientific and public policy issues involving food safety,
food security, nutrition, technical and regulatory matters and consumer
affairs.
NFPA supported the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (Bioterrorism Act) and has
participated in the development of implementing regulations by
providing comments to the Food and Drug Administration (FDA) on behalf
of our member companies as well as by leading the food industry's
coalition on the Bioterrorism Act regulations to assure broad industry
input on FDA's regulatory proposals. FDA has responded to many of the
recommendations from industry to make the implementing regulations more
effective and workable for industry compliance. For example, in the
interim final rule for prior notice of imported foods, FDA decreased
the times during which a prior notice can be filed to better reflect
current business practices and to better harmonize FDA requirements
with those of U.S. Customs and Border Protection (CBP). FDA has also
committed to determine if closer harmonization with CBP's prior notice
requirements is possible. In the facility registration interim final
rule, FDA reduced the amount of mandatory information that must be
provided so that emphasis is placed on collecting information most
relevant to meeting the provisions of the Bioterrorism Act and reducing
the need for updating information that would be of minimal benefit.
The remainder of my comments today focus on remaining industry
concerns about FDA's implementation of the Bioterrorism Act's
provisions for the registration of food facilities; prior notice of
imported food shipments; and the establishment, maintenance and
availability of records.
Registration of Food Facilities
FDA estimates that there are approximately 400,000 domestic and
foreign facilities subject to the registration requirement. FDA's
latest compliance report on registration, however, indicates that only
about 200,000 facilities have registered. While FDA may have over
estimated the number of facilities that are subject to the registration
requirement, a large number of facilities and companies may be unaware
that they must register with FDA. More effort is needed to inform the
regulated industry of the registration requirements, including
additional guidance from FDA on what facilities do not need to
register. FDA's current approach to clarifying facility registration
requirements includes posting on their web site responses to questions
raised by industry. NFPA has asked, for example, about the need to
register facilities that hold food as an incidental part of their
business, such as facilities that hold food for stocking on-site
vending machines or facilities dedicated to consumer testing of food
products. While FDA has provided guidance exempting certain facilities
from registration, such as private residences that hold food for
subsequent distribution to consumers, we believe additional exemptions
are warranted. FDA's guidance and interpretation of the rule has been
slow in coming and needs to be provided in a more timely manner to
facilitate proper industry response.
FDA issued a compliance policy guide for facility registration in
December 2003 that under limited circumstances gives regulated
facilities that have not registered the opportunity to come into
compliance before enforcement action is taken. This enforcement
approach fosters industry awareness of and compliance with the
requirement to register. The existing enforcement policy should remain
in effect until it is clear that the majority of the regulated
facilities are in compliance.
Prior Notice of Imported Food Shipments
The major problem posed by FDA's interim final rule for prior
notice of imported food shipments concerns the inability of industry to
import research and development samples.
Our members have informed us that small quantities of food products
are frequently purchased at retail in foreign countries to evaluate
against comparable U.S. products or to determine the potential for
producing a similar product in the United States. For these research
and development samples, the U.S. manufacturer has no practical way of
securing the registration number of the facility in which the products
were produced. However, under FDA's rule the registration number of the
facility at which a product is produced must be included in the prior
notice to bring the product into the country, a requirement that is not
mandated in the Bioterrorism Act. Without an alternative means of
identifying the manufacturer of the foreign product, research and
development samples will be denied entry to the United States, thus
eliminating what our members indicate is a valuable tool for evaluating
U.S. products and new product development. This places U.S. companies
at a competitive disadvantage and encourages the relocation of research
and development activities to Canada, for example, where import of
samples is not restricted.
Also, FDA and CBP prior notice requirements are not the same. As I
noted previously, FDA did change the minimum time during which a prior
notice must be filed and efforts are underway to determine if the FDA
and CBP prior notice requirements can be more closely aligned. However,
FDA and CBP have indicated that full enforcement of FDA's prior notice
requirements will begin in mid-August of this year, before prior notice
requirements are harmonized. Also, CBP programs, which allow approved
low risk carriers and manufacturers facilitated entry into the United
States, will not be available for shipments that consist of or include
food. In other words, by mid-August, a single, harmonized federal
system for providing prior notice for imports of food will not be in
place. Any food imported into the United States will be held at the
border until a prior notice is provided that meets FDA's requirements,
even if CBP requirements have been satisfied. FDA and CBP are urged to
accelerate harmonization efforts and to move as quickly as possible to
a single prior notice system.
Establishment, Maintenance and Availability of Records
While FDA's final rule for the establishment and maintenance of
records has not been issued, I want to highlight key issues raised in
NFPA's comments on the proposed rule. FDA proposed allowing existing
documentation to be used to satisfy the records requirements, if the
required information is provided. NFPA agrees with this approach, which
takes advantage of existing record keeping systems.
The proposed rule would require companies to have information
describing products and identifying sources of ingredients and
recipients of products available for each lot of product with the
caveat that this level of detailed information would be required where
feasible. FDA has indicated that its interpretation of ``where
feasible'' will essentially mean that all packaged food processors
would be required to have detailed information on ingredient sources
and product recipients for each lot of production. While FDA does not
define what it considers to be a lot of production, we assume this
means each set of product that has the same identification code or was
produced during a given time period. Due to the nature of product
distribution, particularly direct store delivery, this requirement
would be either impractical or extremely costly to meet. As products
are distributed, it is not possible in many instances to keep track of
the exact lot codes of the products that go to individual stores or
customers using existing records. One NFPA member indicated that to
keep lot level information would potentially cost millions of dollars
for them alone. Equally significant is the fact that lot level
information would likely be immaterial in the event product needed to
be removed from the market. At retail, it is our understanding that
inventory records are not kept based on the lot code of the products.
Similarly, product recalls normally involve removal of all potentially
affected products, rather than selected removal based on lot codes.
NFPA has urged FDA to abandon the requirement that companies maintain
all required information at the lot level and to require information to
be available on the sources and recipients of ingredients or products
at the most precise level practicable for the particular food
production in question. For example, for certain ingredients or
products, such as bulk flour or juice, FDA acknowledges that a company
may only be able to identify a subset of all possible sources rather
than the precise suppliers or sources. This degree of flexibility
should be allowed for all ingredients and products.
FDA's proposal would also require companies to produce
documentation to identify the sources and recipients of food
ingredients or products within four hours of an FDA request during the
workweek and within eight hours of an FDA request on weekends or
holidays. If the most significant need, as FDA indicates in its
proposal, is access to information to identify the immediate previous
sources and subsequent recipients of products and ingredients, then
producing records under the deadlines specified should not be the
priority. NFPA has suggested that FDA rely on the most readily
available information from the companies involved, which may include
information from knowledgeable company staff. FDA review and
interpretation of documentation should not be a condition of taking
needed action to address a terrorism incident. NFPA has suggested 24
hours is a more appropriate time period for producing documentation.
Conclusion
In conclusion, I want to acknowledge FDA's efforts in seeking
industry's input in developing these regulations and the Agency's
willingness to incorporate suggestions to strengthen and improve the
new requirements and to ensure that they are both effective and
achievable in meeting the objectives of the Bioterrorism Act. Thank you
for the opportunity to comment on this very important issue.
Mr. Bilirakis. Thank you, sir.
Is someone in here from FDA taking notes? So you are being
heard, Mr. Cady.
Mr. Clarke.
STATEMENT OF ROGER CLARKE
Mr. Clarke. Mr. Chairman, I would like to thank yourself
and the committee for the opportunity to address this body.
And I represent multiple associations, mainly the Customs
Brokers Associations, both regional and national. The Customs
Brokers, as a little bit of background, is probably the front
line in the Bioterrorism Act as far as transmitting data into
the systems. 80 percent of all data being transmitted will be
done by Customs brokers at the Customs and Border Protection
Automated Commercial System Automated Broker Interface.
Basically, we are the ones who are dealing with the actual
information and getting it into the Agency. The requirements
under Section 307 of the Bioterrorism Act, prior notice, has
been expanded by the Agency to include vast amounts of data to
be transmitted far beyond the seven data elements that are
required by the bill itself.
Customs and Border Protection and Food and Drug have done
outreach programs to the commerce and to the trade in the
overall aspect of the bill itself, but they have been, we feel,
a little bit negligent in the area of specific training in the
details of the prior notice functions. As a good example, to
give a timeframe of what amount of data is being transmitted on
a simple shipment that I deal with, the requirements to
transmit the data to Food and Drug required 934 separate
transmissions for one imported shipment. And part of that is
because of the convoluted amount of data that is required by
Food and Drug.
A good example: You have a shipment of tuna coming in. Food
and Drug requires it broken out by specific size of tuna, even
though that product is from the same manufacturer, the same
product. Again, it requires separate transmissions based on the
size of the container. We do not feel that as a security issue
of protecting the public health on a prior notice basis would
require that level of detail. Customs and Border Protection is
reviewing every single shipment that is coming into the
country.
Under the Container Security Initiative, 24-hour prior to
loading of any cargo coming into the United States, that data
is transmitted into Customs and Border Protection. We feel Food
and Drug could utilize that information in supplement to the
prior notice.
We also feel that prior notice could be linked to the entry
process versus the arrival process. The Law Registry refers to
importation into the United States. Many of the unique problems
encountered in the operational side of the bill or the prior
notice interim rules relates to the timing of the actual
arrival. If it was shifted to the arrival of the cargo based on
entry versus based on time of arrival, many of the operational
problems would be resolved.
As I mentioned before, there is a mass confusion, and we
feel amongst not only the brokerage industry but against the
importing industry on the fact of what exact details are
actually needed in the transmission and the actual relief
required. A good example would be, part of the transmission--
would be the flag of the vessel. A lot of time and resources
are devoted to find that one piece of information when in fact
it has no bearing on the admissibility of the cargo itself
under the Bioterrorism Act.
Just to briefly summarize some of the areas that we feel
have some real serious concerns. There is no validation being
done on the data that is being transmitted in. We have no
feedback from either Agency whether that data is correct or
not. We only get confirmation that the data has been
transmitted.
There is a mismatch between the data bases that are being
used. The registration data base, which is confidential in the
Food and Drug Administration, is compared to the data base that
is being used in the Customs and Border Protection, which is an
18-year-old data base and very corrupted. Industry has no way
of altering that or changing that or amending it.
Also the PNSI, that is the Prior Notice System Interface by
Food and Drug, has some very serious concerns. In fact, it was
designed for very limited use, not for the mass amount of
commercial information being transmitted, and that is the main
backup system for the initial ABI system or automated broker
interface that we are using now to transmit data via Customs
and Border Protection. We have had two major shutdowns. Both
shut downs had demonstrated that the system is incapable of
handling it properly, timely, in the present form.
Again, as related earlier, the samples coming into the
United States do not pose a serious health threat when they are
going for laboratory analysis only, and that should be
addressed. Again, vast amounts of duplicate information, we
transmit not only the prior notice data, but the admissibility
data through Food and Drug. That is two separate admissions
with a large amount of duplicate information in addition to
duplicated indicated information being transmitted to Customs
and Border Protection.
We feel some of these fixes need to be done prior to the
August 12 implementation date. And we feel that consideration
should be given to expand that. The final or not the final but
the present comment period will end July 13, which only gives
30 days for the Agencies to make adjustments to the system
which we believe is flawed, and we have made comments to that
fact. And then, in fact, it is going to take time for industry
to make the same type of adjustments within their automated
systems. Again, by pushing back the implementation date, we
feel that will be a benefit for both the Agencies to do their
job better and mostly for industry to adjust properly.
I thank the committee for the time given to me to address
some of these concerns, and I will be willing to answer any
specific questions they may have. Thank you.
[The prepared statement of Roger Clarke follows:]
Prepared Statement of Roger Clarke, Williams and Clarke Co.
I. INTRODUCTION
Good morning. My name is Roger Clarke and it is an honor to
participate in this hearing today. I am here to represent a broad
cross-section of the U.S. importing public. My own company is Williams
Clarke Company, a licensed customs brokerage and OTI firm located in
Los Angeles, California, that handles a large number of food import
accounts. I am the Chair of the FDA Committee of the Pacific Coast
Council of Customs Brokers and Freight Forwarders Associations. The
Pacific Coast Council is the voice of the customs brokers, forwarders
and NVOCCs in California, Oregon and Washington, the nation's largest
international trade gateway.
I am also speaking today on behalf of the National Customs Brokers
and Forwarders Association of America, representing customs brokers and
forwarders nationwide; the Agriculture Ocean Transportation Coalition,
representing agriculture exporters and importers nationwide; the
Coalition of New England Companies for Trade; and the New England
Seafood Producers Association.
What these groups have in common is this: they all deal in food
imports covered by the Prior Notice provisions of the Bioterrorism Act,
and they each have concerns regarding how these provisions are being
implemented, and how they will impact legitimate food imports once full
enforcement begins.
II. BACKGROUND
To begin, allow me to say that the organizations I represent
support the intent of the Bioterrorism Act of 2002, which was to
protect our nation's food supply from the threat of bioterrorism. As
those who import food and process such imports, we are ready to do what
is necessary to achieve the objectives of the Act. Further, we
recognize that FDA has been given an enormous task in implementing the
food provisions of the Act, without significant additional resources.
We are pleased that FDA had the foresight to invite CBP to assist in
implementing and enforcing the Prior Notice provisions, and to utilize
the ABI/ACS system for submission of Prior Notice.
Despite the efforts of both FDA and CBP to develop and implement a
workable Prior Notice system, there are significant flaws with the
program that must be addressed before the final phase of enforcement
begins on August 12. We are concerned that if these issues are not
addressed, there is significant potential for legitimate food imports
to be stopped at the docks--an expensive exercise for the food
importer, and we believe a waste of precious FDA resources needed to
prevent bioterrorism.
III. WHAT NEEDS TO BE FIXED
Each of our industry associations has submitted comments to FDA
detailing the issues which we believe need to be addressed prior to
full enforcement. I will mention only a few of the major issues which
impact the ability of the food importing public to comply with the
objectives of the Act.
A. The FDA Prior Notice System Interface, PNSI, needs to be ramped
up to accommodate all Prior Notice submissions in case of ABI system
failure. As the Committee likely knows, the majority of Prior Notice
submissions are sent through the Customs ABI/ACS system. When this
system is down the PNSI system must be capable of handling all of the
overload. Currently PNSI is insufficiently robust to handle the volume
processed in ABI/ACS, and has built-in inefficiencies that render it
unsuitable for commercial use even when it is not under stress.
B. We have advocated that the Customs ABI/ACS system be
reprogrammed to accept 100% of all Prior Notice submissions so as to
eliminate the need for filers to operate in both PNSI and ABI/ACS.
Thus, we are very pleased that the new ``Independent Prior Notice''
program will allow filing of Prior Notice through ABI/ACS independent
of the Customs entry filing. However, as this program has just recently
unveiled, the importing public needs time to make the necessary
programming changes in order to avail itself of the program. We
encourage FDA to delay full enforcement until the new ``Independent
Prior Notice'' system is fully operational.
C. Safeguards are needed to protect the parties of interest from
unauthorized filing of Prior Notice on their behalf. To this end, FDA
could require those who submit Prior Notice to have power of attorney
to act on behalf of the party of interest, or could license submitters.
The current system does not protect against duplicate Prior Notice
filings, and could lead to confusion in an emergency situation.
D. The Prior Notice system should be revised to allow greater
ability to correct errors after the Prior Notice has been submitted--
even if the change occurs after the Prior Notice is due. For example,
often product changes hands on the water, or a sale falls through and
another importer is identified after the product has arrived in the
U.S. This is customary business practice. Under the current rule, it
wouldn't be possible to make the change without risking significant
penalties, or possibly even rejection of cargo. Again, we have a
suggestion that would address this problem as well.
E. Certain exemptions are needed for pre-purchase and trade samples
used exclusively for research and development or laboratory analysis,
and thus not for sale or distribution to the public; household goods
(personal effects and property) shipped to the U.S.; and unadulterated
U.S. exports that have been returned to the U.S.
F. The reporting timeframes for Prior Notice and CBP's Advance
Notice should be harmonized to mitigate the burden and expense on food
importers of meeting both requirements.
G. Congress should amend the Act to eliminate the requirement that
Prior Notice be submitted no earlier than 5 days before arrival in the
U.S. We cannot fathom the reasoning behind such a requirement. After
all, CBP is screening cargo data 24 hours prior to vessel loading at
the foreign port.
H. The Prior Notice system absolutely must be revised to assure
that the party who submits Prior Notice is notified immediately if the
product is refused entry due to Prior Notice violations. Currently only
the carrier, who has no ability nor incentive to resolve the refusal,
is notified.
I. We urge FDA to eliminate the existing requirement for separate
Prior Notice based on packaging and quantity. We do not believe there
is any security justification for imposing this costly and unnecessary
burden on the importing public.
J. Last, but certainly not least, FDA needs to provide further
education and guidance to the food import community prior to full
enforcement. FDA did a very effective job of providing training on the
basic structure of the Prior Notice system. But food importers have
questions related to practical application of the system to their
import operations, and are having difficulty getting answers. We
believe that it is clear that further clarification is needed. FDA must
find a way to reach out to the regulated public to provide the
education needed to assure greater compliance. This could be
accomplished through additional guidance documents, educational
seminars, web-based training, etc. FDA's own Compliance Policy Guide
states that such outreach would continue throughout the eight months
between implementation and full enforcement. Yet this has not occurred,
and we feel it is needed.
Again, these are just some of the revisions to the Prior Notice
program that we feel are needed to make it workable for those of us
involved in importing food into this country.
IV. OUR RECOMMENDATION TO CONGRESS AND FDA
As previously noted, we support the objective of safeguarding our
nation's food supply. We believe that the current Prior Notice system
could be modified in such a way that would maintain the safeguards
currently in place under the Act, while alleviating some of the burden
on the importing public, as well as on FDA and CBP.
Instead of requiring Prior Notice before arrival of the cargo in
the U.S., we believe that Prior Notice should be required prior to
release of the cargo by CBP. This means that product would not be
refused entry for lack of Prior Notice, but could never enter the
stream of U.S. commerce until FDA had received--and reviewed--the Prior
Notice submission. Since CBP already screens cargo manifest data to
assure that its physical presence poses no hazard to the U.S., it seems
that FDA's focus of assuring that food for consumption in the U.S. is
safe for people (and animals) could just as well be achieved by
assuring that no shipment is released for consumption until and unless
the Prior Notice requirement have been met. Until such time as the
cargo is released, it would (and, in fact, currently does) remain in
the continuous custody of CBP, thereby posing no threat to the
consuming public.
Such a mechanism would address several of the key concerns I have
already raised, such as problems where one cannot currently meet the
Prior Notice requirements through the ABI/ACS system for live entry
items, the need to harmonize FDA and CBP reporting timeframes, and the
current inability to make critical revisions to the Prior Notice after
cargo has arrived in the U.S. Under the system I have just described,
cargo wouldn't be refused entry for an unavoidable error--one would
simply re-file and await the requisite release by FDA (and CBP), with
no penalty. In effect, the penalty on the importer would be that the
cargo would be held until the proper Prior Notice were filed and
approved by FDA. The system would also capture cargo entering Foreign
Trade Zones, or moving under ``T&E''--if such cargo were subsequently
destined for domestic consumption one would need to file a
``Consumption Entry'' with Customs, and such entry would be contingent
upon review and approval of Prior Notice by FDA.
We highly encourage the Committee and the agencies to consider this
revision to make a more workable--and equally effective--Prior Notice
system. In fact, we believe this system would be significantly more
effective, since it would assure that FDA and CBP do not waste valuable
resources on enforcement actions against legitimate food imports that
pose no threat to the public.
V. ENFORCEMENT
I would like to make a few comments on the enforcement of the Prior
Notice provisions. First, we have been urging FDA to postpone full
enforcement until the final changes to the Prior Notice system are
made, AND the food import community is given both the time and guidance
needed to accommodate these changes. I think I can speak for the entire
food import community when I say we want to be in compliance, and we
don't want our cargo sitting on the docks, or in a General Order
warehouse because what we thought was a proper Prior Notice filing
turned out to be incorrect or inadequate. Until the program is
finalized--presumably sometime after July 13--we cannot be certain what
will be expected of us. What we do know is that we will need more than
30 days to understand the most recent changes and make the programming
revisions needed to accommodate the changes. Thus we are asking FDA to
postpone the final enforcement phase until 60-90 days after FDA
finalizes the Prior Notice System.
Second, since there will likely be glitches that appear only after
full enforcement, we encourage FDA not to finalize the Interim Final
Rule without providing additional opportunity for public comment. We
suggest that this final comment period begin 6 months after full
enforcement takes effect, and that the public be given a minimum of 60-
90 days to make its final comments on the system. This way we can be
sure to have a Prior Notice system that works for everyone.
Finally, with regard to the FDA's most recent guidance on
penalties, we have serious concerns that we hope the agency will
address:
1. Despite the fact that all administration of the Bioterrorism
regulations has been centralized within FDA Headquarters, to
the purposeful exclusion of the field offices, FDA has
announced that penalties will be determined at the Port level.
We feel this will lead to inconsistencies and ``port
shopping,'' and that penalties are best handled by Headquarters
as well.
2. We disagree with FDA's decision to penalize both the submitter and
the transmitter for an untimely filing.
3. Since many entries/importations have numerous Prior Notice
transmissions, an error on one of the transmissions could
generate numerous violations.
4. The first violation, option 1 amount is set at $500.00 for
inaccurate PN and treats all inaccuracy the same (clerical
error vs. misstatement of fact.
VI. CONCLUSION
I greatly appreciate the opportunity to provide input to the
Committee on implementation of Title III of the Bioterrorism Act. I
would like to close by emphasizing that we all are striving towards a
common goal--that of ensuring the safety of our food supply. We believe
this can be achieved without significant disruption to the trade if
certain key elements are revised to reflect common business practices.
We highly recommend that the Committee and the agencies consider our
proposal to condition release of cargo by CBP on receipt and approval
of Prior Notice by FDA. We strongly believe this would resolve many of
the issues that continue to plague the current Prior Notice system.
Finally, I would like to commend both FDA and CBP for their efforts to
implement this new program within a very tight timeframe, and with very
little additional resources. We recommend that the Committee, in
recognition of both the importance and scope of this new security
program, provide both agencies with the funding needed to meet the
intent of the Bioterrorism Act.
Thank you.
Mr. Bilirakis. Thank you very much, Mr. Clarke.
Mr. French.
STATEMENT OF DAVID FRENCH
Mr. French. Mr. Chairman and Members of the subcommittee, I
am David French, Senior Vice President of Government Relations
for the International Foodservice Distributors Association, and
I thank you for the opportunity to testify today on behalf of
IFDA's 130 broadline and specialty food service distributors.
IFDA strongly supports the purposes of the Bioterrorism
Act, and our members are committed to safeguarding the quality,
safety and integrity of the product that they distribute. IFDA
members operate more than 550 facilities and sell more than $75
billion worth of food and related products to restaurants and
institutions in the food-away-from-home business. The average
IFDA member has approximately $50 million in annual sales and
handles slightly more than 2 million cases of foodservice
product per year. Implementation of the food provisions of the
2002 law seems to be going very well.
But before I comment on what the FDA has done well, I want
to spend a moment discussing the looming threat of FDA's
recordkeeping rule, which we view as the most difficult and
burdensome of the regulations required by the Bioterrorism Act.
The interim final rule on record maintenance and inspection has
been delayed for several months. IFDA is hopeful that FDA has
been using this time to undertake a substantive rewrite of the
proposed rule because our industry has expressed many serious
reservations about the initial FDA proposal.
I would like to mention a few of the problems we saw in the
proposed rule. The Bioterrorism Act calls for firms to maintain
records of their transactions and to make these records
available to the FDA to assist in investigations. On its face,
these seem to be reasonably simple requirements. After all,
foodservice distributors typically retain records for at least
2 years. Food firms also routinely conduct voluntary recalls of
misbranded or adulterated food products, so all parts of the
food distribution business have experience with conducting
trace-back and trace-forward investigations. In fact, it is
common for our companies to practice mock recalls at the
request of their larger customers.
Unfortunately, rather than building on the existing systems
that food companies employ to keep track of product and conduct
recalls, the FDA proposed a rigid bureaucratic and one-size-
fits-all rule. If key elements of the proposal find their way
into the final rule, many of the companies in our industry will
be facing multimillion dollar information system upgrades that
will yield no significant improvement in the effectiveness of
food investigations and recalls. I would add that compliance is
a very serious matter insofar as failure to maintain the
required records or failure to provide access to these records
within the required timeframe subjects the company to civil and
criminal liability.
One element of the proposed rule that concerns us is the
requirement that companies retain the lot number or other
identifier for each article of food that they send or receive.
The requirement to record lot numbers is problematic for
foodservice distributors. Distributors handle food in pallets
and cases. A single pallet may contain food from multiple lots.
And the lot numbers often appear only on the individual food
packages. There is no government or industry standard for
location or presentation of lot numbers so they may appear on
product packages or on cases, may be embedded in the UPC code
or stand alone and may take a variety of forms. Most
importantly, lot numbers are not generally included on
invoices. In many cases, the requirement to record lot numbers
would mean the distributors must break open cases and search
for lot numbers to record. This is a key point and an issue
that has people in charge of logistics and operations very
worried.
Therefore, we have requested the FDA give companies
discretion to determine what is an appropriate identifier. Most
distributors track food by purchase order number. All foods
have a purchase order and a purchase order number. If a
manufacturer recalls a product, it is an easy matter to
determine a purchase order number, trace the product and remove
it from commerce.
Another significant concern involves the timeframe for
production of records. The proposed rule sets very short
timeframes within which companies are required to make records
available to FDA. As little as 4 hours is permitted if the
request is made during normal business hours. Moreover, it is
not entirely clear from the proposed rule when the clock will
begin to run.
Section 306 of the Bioterrorism Act makes failure to
produce records within this timeframe a prohibited act. Under
the Federal Food Drug and Cosmetic Act, a prohibited act is
criminal offense and company executives can be held personally
criminally liable. Given the serious consequences of
noncompliance, we view the imposition of a hard and fast 4-hour
timeframe as unreasonable. While these records can be retrieved
quickly in an emergency, a 4-hour deadline during normal
business hours will not always be feasible. And we question
whether imposition of criminal liability for a violation such
as this is appropriate.
We are also concerned that the FDA pay heed to the
legislative history regarding when it may obtain access to
records. Because the Bioterrorism Act gives FDA access to
highly sensitive commercial information, it is important that
the new records access authority be used appropriately. While
the Bioterrorism Act requires the FDA to take appropriate
measures to prevent unauthorized disclosure of trade secrets or
confidential information, the proposed rule did not address
this issue.
The FDA is now three-fourths of the way through the
rulemaking process. The interim final rules on registration and
prior notice and the final rule on administrative detention
have all been written. And the foodservice distribution
industry is generally pleased with the significant cooperation
and understanding that the FDA has shown in responding to the
industry's concerns. FDA has done an impressive job of
listening and responding to various workability issues raised
by numerous comments on the rulemaking process, and the Agency
should be commended for this.
In the brief experience that our companies have had with
these rules, they have reported very few supply disruptions or
concerns. Smooth implementation of the first three regulations
is due to several factors which have been summarized in my
written submission.
While we are generally pleased with the implementation of
the first three rules under the Bioterrorism Act, there are
some serious concerns with regard to the prior notice rule,
FDA's phasing in enforcement of the rule through Agency
discretion and educational outreach. As mentioned earlier, no
real education seems to be happening. While FDA is keeping
track of and posting data on a number of inadequate prior
notices, FDA is not telling industry why these prior notices
are deficient. We hope that FDA will step up its educational
efforts before full enforcement of the prior notice rule begins
on August 13.
In addition, our members are reporting significant problems
with FDA failing to make timely inspection decisions along the
Canadian border. Whether the problems are related to the
Bioterrorism Act or prior notice or simply a reflection of a
sizable number of new inexperienced inspection personnel on the
job, we have heard that many products imported from Canada are
not receiving timely decisions from FDA. In some cases, FDA
inspectors are taking an inordinate amount of time to decide
whether or not to sample imported product. As the legislative
history of the act makes clear, FDA review of prior notice
should not delay or unnecessarily disrupt the flow of commerce.
Mr. Bilirakis. Please summarize.
Mr. French. I am close to concluding, Mr. Chairman.
We understand that implementation involves a learning curve
for FDA as well as industry, and we hope that these delays will
disappear.
Thank you for the opportunity to present this statement,
and I am happy to answer any questions.
[The prepared statement of David French follows:]
Prepared Statement of David French, International Foodservice
Distributors Association
Mr. Chairman, Mr. Waxman, and members of the Committee, I am David
French, senior vice president of government relations for the
International Foodservice Distributors Association, and I thank you for
the opportunity to testify today regarding the Food and Drug
Administration's implementation of the food provisions of the
Bioterrorism Act of 2002. IFDA strongly supports the purposes of the
Bioterrorism Act, and our members are committed to safeguarding the
quality, safety, and integrity of the products that they distribute.
IFDA is a trade organization representing foodservice distributors
throughout the U.S., Canada, and internationally. IFDA's 130 members
include broadline and specialty foodservice distributors that supply
food and related products to restaurants and institutions in the ``food
away from home'' business. IFDA members operate more than 550
facilities, and sell more than $75 billion in food and related
products. The average IFDA member has approximately $50 million in
annual sales and handles slightly more than two million cases of
foodservice product per year. Formerly a division of Food Distributors
International, IFDA was established as an independent trade association
on January 1, 2003.
In general, I can report that the implementation of the food
provisions of the 2002 law has gone much more smoothly than expected.
But before I comment on what the FDA has done well, I want to spend a
moment discussing the looming threat of the FDA's recordkeeping rule.
The recordkeeping rule is generally viewed as the most difficult and
burdensome of the regulations required by the Bioterrorism Act.
As you know, the interim final rule on record maintenance and
record inspection has been delayed for several months. IFDA is hopeful
that the FDA has been using this time to undertake a substantive
rewrite of the proposed rule, because our industry has expressed many
serious reservations about the initial FDA proposal. I'd like to
briefly mention a few of the problems we saw in the proposed rule.
The Bioterrorism Act calls for food firms to maintain records of
their transactions for some length of time and to make these records
available to FDA to assist in trace back and trace forward
investigations. On its face, these seem to be reasonably simple
requirements. After all, foodservice distributors typically retain
records for at least two years. Food firms also routinely conduct
voluntary recalls of misbranded or adulterated food products, so all
parts of the food distribution business have experience with conducting
trace back and trace forward investigations.
Unfortunately, rather than building on the existing systems that
food companies employ to keep track of product and to conduct recalls,
the FDA proposed a rigidly bureaucratic and one-size-fits-all rule. If
key elements of the proposal find their way into the final rule, many
of the companies in our industry will be facing multi-million dollar
information system upgrades that will yield no significant improvement
in the effectiveness of food investigations and recalls. I would add
that compliance is a very serious matter insofar as failure to maintain
the required records, or failure to provide access to these records
within the required time frame, subjects a company to civil and
criminal liability.
One element of the proposed rule that concerns us is the
requirement that companies retain the lot number ``or other
identifier'' for each article of food that they send or receive. A
requirement to record lot numbers is problematic for foodservice
distributors. Distributors handle food in pallets and cases. A single
pallet may contain food from multiple lots, and the lot numbers often
appear only on the individual food packages. There is no government or
industry standard for location or presentation of lot numbers, so they
may appear on product packages or on cases, may be embedded in the UPC
code or stand alone, and may take a variety of forms. In many cases, a
requirement to record lot numbers would mean that distributors must
break open pallets and cases and search for the lot numbers to record.
This is a key point, and an issue that has the people in charge of
logistics and operations in IFDA member companies very worried.
Therefore, we have requested that FDA give companies considerable
discretion to determine what is an appropriate identifier. Most
distributors track food by purchase order number. All foods have a
purchase order and purchase order number. If a manufacturer recalls a
product or if it is necessary to trace a food shipment for any other
reason, it is an easy matter to determine a purchase order number,
trace the product, and remove it from commerce.
Another significant concern that the foodservice industry has
raised regarding the proposed rule involves the time frames for
production of required records. The proposed rule sets very short time
frames within which companies are required to make records available to
FDA in response to an official request--only four hours if the request
is made during normal business hours. Moreover, it is not entirely
clear from the proposed rule when the clock begins to run. Section 306
of the Bioterrorism Act makes failure to produce records within this
time frame a ``prohibited act.'' Under the Federal Food, Drug, and
Cosmetic Act, a ``prohibited act'' is a criminal offense, and company
executives can be held personally criminally liable.
Given the serious consequences of non-compliance, we view the
imposition of a hard-and-fast four-hour time frame as unreasonable.
While these records can be retrieved quickly in an emergency, a 4-hour
deadline during normal business hours (or an 8-hour deadline outside of
normal business hours), as proposed by FDA, is not feasible. IFDA
agrees that FDA must have quick access to records in the event of an
emergency. Imposition of criminal liability for violation of such a
short timeframe, however, is inappropriate. Instead, FDA should require
that records be made available in a reasonable period of time. As the
courts have been able to determine what constitutes reasonable times
and places for FDA inspection under FD&C Act section 704, so too can
the courts apply a reasonableness standard to the time frames for
records access.
A third concern we have deals with the circumstances of records
access. We are concerned that FDA pay heed to the legislative history
regarding when it may obtain access to records. According to one of the
sponsors of the Bioterrorism Act, John Shimkus (R-IL), FDA ``shall
ensure that adequate procedures are in place to ensure agency personnel
will not have access to records without a specific reason and need for
such access, and that possession of all copies of records will be
strictly controlled . . .'' Cong. Rec. E2388 (Dec. 20, 2001). Because
the Bioterrorism Act gives FDA access to highly sensitive commercial
information, it is important that the new records access authority be
used appropriately and not abused and that strong protection be put in
place to prevent inappropriate release of sensitive information. While
the Bioterrorism Act requires that FDA take appropriate measures to
prevent unauthorized disclosure of trade secret or confidential
information, the proposed rule did not address this issue.
The FDA is three-fourths of the way through the rulemaking process.
The interim final rules on registration and prior notice and the final
rule on administrative detention have all been written, and the
foodservice distribution industry is generally pleased with the
significant cooperation and understanding that the FDA has shown in
responding to the industry's concerns. FDA has done an impressive job
of listening and responding to various workability issues raised by
numerous comments during the rulemaking process, and the agency should
be commended for this.
In the brief experience that our companies have had with these
rules, they have reported very few supply disruptions or concerns.
Smooth implementation of the first three regulations is due to several
factors. First, in the case of the prior notice rule in particular, FDA
made a serious effort to address industry concerns raised during the
rulemaking and the interim final rule was far less onerous than the
proposed rule. Second, FDA has been phasing in enforcement of the prior
notice and registration rules, so implementation problems may become
more noticeable in the near future when full enforcement begins. Third,
the prior notice rule has little direct impact on foodservice
distributors, since with a few exceptions, foodservice firms do not
import product directly. Instead, they work with importers and brokers
who handle transactions with foreign suppliers. Importers may also be
keeping their inventories larger than usual in order to minimize
disruptions. Finally, firms in our industry, following FDA guidance,
generally work with known suppliers. These suppliers are likely to be
larger and more capable of working within the FDA rules.
While we are generally pleased with implementation of the first
three rules under the Bioterrorism Act, there are some serious
concerns. With regard to the prior notice rule, as previously
mentioned, FDA is phasing in enforcement of the rule. We are currently
in a period of enforcement discretion and educational outreach.
Unfortunately, no real education is happening. While FDA is keeping
track of and posing data on the number of inadequate prior notices it
receives, FDA is not telling industry why these prior notices are
deficient. We hope that FDA will step up its educational efforts before
full enforcement of the prior notice rule begins on August 13.
In addition, our members are reporting significant problems with
FDA failing to make timely inspection decisions along the Canadian
border. It is not clear whether this problem is related to the
Bioterrorism Act and prior notice or simply a reflection of a sizable
number of new, inexperienced inspectional personnel on the job; but we
have heard that many products imported from Canada are not receiving
timely decisions from FDA. In some cases, FDA investigators are taking
an inordinate amount of time to decide whether or not to sample
imported product. As the legislative history of the Bioterrorism Act
makes clear, FDA review of prior notice ``should not delay or
unnecessarily disrupt the flow of commerce.'' Cong. Rec. E2389 (Dec.
20, 2001). We understand that implementation involves a learning curve
for FDA as well as industry, and we hope that these delays will
disappear.
Thank you for the opportunity to present this statement, and I am
happy to take any questions.
Mr. Bilirakis. Thank you very much for your statement.
Ms. Stout.
STATEMENT OF SUSAN M. STOUT
Ms. Stout. Good morning Mr. Chairman.
I am Susan Stout. I am Vice President of Federal Affairs of
the Grocery Manufacturers of America. We are led by a Board of
42 chief executive officers, and GMA is the world's largest
association of food, beverage and consumer product companies.
With U.S. sales of more than $500 billion, GMA members employ
more than 2.5 million workers in all 50 States.
The subcommittee hearing today is timely and a useful
review of where things stand 2 years following enactment of the
Bioterrorism Act. Thus far, FDA, as you know, has issued final
regulations on detention, interim final rules on registration
and prior notice and a proposed rule on recordkeeping. The FDA
has been accessible and open to suggestions to improve the
workability of these regulations from those who have to make
the regulations work, the food industry.
No regulation is ever perfect, and I am not suggesting that
the FDA's bioterrorism regulations are perfect. The food
industry has been concerned about the provision for prior
notice of imported foods from the beginning of this process.
When FDA issued proposed regulations to implement prior notice
in February 2003, our worst fears were realized. That proposal
would have been costly, duplicative, unworkable and likely to
have led to lines at the U.S. entry points that would have
rivaled those at airport security checkpoints.
GMA's comments on the proposed prior notice regulations
discussed all of the problems with the FDA proposal and made
suggestions for improvements. To its credit, the interim final
regulation that FDA issued on October 10, 2003 did address most
of the egregious workability problems, but we don't know
whether the prior notice system will work.
Let me explain what I mean by that. FDA has properly
provided for a period of time after publication of the interim
final rule for itself, Customs and Border Protection and the
food industry to become educated about the requirements and to
implement systems to enable compliance. This educational phase
is scheduled to conclude in the middle of August, at which time
full enforcement begins. We do not believe that anyone can
confidently predict what will happen when full enforcement does
begin.
However, although companies have been submitting prior
notices since last December, FDA has provided little if any
feedback on deficiencies of specific notices. Companies can
only guess what problems might have occurred. Additionally,
FDA's own data show that more than one-third of prior notices
submitted as recently as this April were deemed incomplete. If
FDA were now fully enforcing the requirement, more than 50,000
notices per week would be ineffective and the food covered by
those notices denied entry into the United States.
Another troubling issue with prior notice relates to the
FDA imposed requirement that all prior notices contain the
facility registration number where the food was produced. In
some instances, it is not possible to satisfy this requirement,
yet FDA has not provided a solution. This requirement is
particularly problematic for trade and product samples.
Congress intended prior notice to assist the FDA in
allocating resources to examine and inspect potentially high-
risk shipments of food. FDA's limited resources should not be
spent examining food product samples that are not for public
consumption or retail sale and clearly do not present major
food security issues. Easing this burden for product samples
would have to ensure that food companies, in order to conduct
their testing, do not have to relocate the product analysis
facilities outside of the United States. FDA must provide some
relief.
The second rulemaking of particular concern is
recordkeeping. Under the Bioterrorism Act, FDA is authorized to
require the maintenance of records of food to show the
immediate person from whom the food was received and the
immediate person to whom the food was distributed. These
records are intended to assist FDA in tracing the movement of
food in the event of a serious problem involving that food.
FDA has proposed to require food companies to maintain
records that include lot or production codes for product
delivered to the retail stores. GMA has vigorously objected to
this proposed requirement as contributing nothing to food
security while being incredibly time-consuming and burdensome.
We have urged FDA to remove this requirement from the
recordkeeping regulation. I have inserted a copy of our
comments on this subject in my testimony.
The delivery of food to retail stores occurs in various
ways. A growing number of our food companies use so-called
direct-store delivery. In direct-store delivery, the food
manufacturer delivers product to the retailer, restocks the
shelf, replacing older product with new, using company vehicles
and company employees. I am sure you have seen the GMA company
trucks at your local grocery stores. If there is a problem with
the particular food, the manufacturer will move all of the
potentially offending food, not just a specific lot or code
amount from distribution until the magnitude and scope of the
problem is determined. Retailers will do exactly the same
thing.
We very much hope that in the final recordkeeping
regulation, FDA will remove this ill advised and unnecessary
proposed requirement for lot and production codes.
Thank you, Mr. Chairman.
[The prepared statement of Susan M. Stout follows:]
Prepared Statement of Susan M. Stout, Vice President, Federal Affairs,
Grocery Manufacturers of America
Mr. Chairman and Members of the Subcommittee, I am grateful for the
opportunity to participate this morning in this important hearing.
GMA is the world's largest association of food, beverage and
consumer product companies. Led by a board of 42 Chief Executive
Officers, GMA applies legal, scientific, and political expertise from
its more than 140 member companies to vital public policy issues
affecting its membership. The association also leads efforts to
increase productivity, efficiency and growth in the food, beverage and
consumer products industry. With U.S. sales of more than $500 billion,
GMA members employ more than 2.5 million workers in all 50 states.
A little over two years ago, Congress passed the Public Health
Security and Bioterrorism Preparedness and Response Act. GMA worked
closely with the Members and staff of this Subcommittee and the full
Energy & Commerce Committee to ensure that the additional authorities
provided to Federal regulators were well considered and likely to
contribute to increased food security, and not merely increased burdens
on the food industry. The Subcommittee's hearing today is a timely and
useful review of where things stand two years after enactment.
Before turning to the Bioterrorism Act I want to briefly mention an
important GMA program--Project Vigilance. Ensuring the security of the
food supply is the responsibility of the food industry as well as the
government. Project Vigilance encompasses our actions immediately
following September 11th to help assure the security of food, beverages
and consumer products. Included with my testimony is a description of
the program.
The Bioterrorism Act requires FDA to undertake numerous
rulemakings. Specifically, FDA was required to develop regulations on
food facility registration, administrative detention, prior notice of
imported foods, and recordkeeping. I intend to spend the bulk of my
testimony discussing issues related to prior notice and recordkeeping.
Before turning to those two subjects, however, I want to share with the
Subcommittee a general observation about the development of these
regulations by FDA to implement the Bioterrorism Act.
Thus far, FDA has issued final regulations on detention and interim
final rules on registration and prior notice. The final regulation on
recordkeeping is expected soon. Throughout all of these rulemaking
proceedings, the FDA staff has been accessible, open to suggestions to
improve the regulations, and willing to address issues in the
regulations to improve workability. No regulation is ever perfect and I
am not suggesting that FDA's bioterrorism regulations are perfect. But,
FDA is certainly to be commended for the process that it has used to
develop these regulations and for its willingness to modify proposed
regulations based on comments from those who have to make the
regulations work--the food industry.
Throughout the development of the Bioterrorism Act, the food
industry was most concerned about the provision for prior notice of
imported foods. Our concerns were based on unease about the burden on
importers, questions about integration of the FDA requirements with
those of the U.S. Customs and Border Protection, and, ultimately, the
effects on the cost and availability of food if the prior notice
requirements impeded the importation of food. When FDA issued proposed
regulations to implement the prior notice requirement in February of
2003, our worst fears were realized. That proposal would have been
costly, duplicative, unworkable, and quite likely to have led to lines
at the various entry points through which food enters the United States
that rivaled those at airport security check points.
GMA's comments on the proposed prior notice regulations discussed
all of the problems with the FDA proposal and made suggestions to
improve the prior notice system. To its credit, the interim final
regulation that FDA issued on October 10, 2003, addressed most of the
most egregious problems with the proposal--the time frames for
submission of the notice were shortened, coordination with Customs was
enhanced, and numerous other ``workability'' issues were solved. But,
we don't yet know whether the prior notice system will work. Let me
explain.
FDA has properly provided for a period of time after publication of
the interim final rule for itself, Customs and Border Protection and
the food industry (including food manufacturers, importers, and persons
involved in the transportation and distribution of food) to become
educated about the requirements and to implement systems to enable them
to comply. Currently, this ``educational'' phase is scheduled to
conclude in the middle of August; FDA and CBP will then commence full
enforcement.
We do not believe that anyone can confidently predict what will
happen when full enforcement begins. First, although companies have
been submitting prior notices since last December, FDA has provided
little if any feedback on deficiencies in specific notices. Companies
can only guess what problems might have occurred. Second, FDA's own
data show that more than one-third of prior notices submitted as
recently as April were deemed ``incomplete.'' (``Compliance Summary
Information: Prior Notice,'' April 1, 2004; updated May 2004. U.S. Food
and Drug Administration). If FDA were now fully enforcing the
requirement, more than 50,000 notices per week would be ineffective and
the food covered by those notices denied entry into the United States.
One of the most troubling issues with prior notice relates to the
FDA-imposed requirement that all prior notices contain the facility
registration number of the facility where the food was produced. In
some instances, it is not possible to satisfy this requirement, yet FDA
has not provided a solution. The requirement to provide the
registration number in a prior notice is a particular problem for trade
and product samples. U.S. food companies routinely import samples for
analysis and review. Some of these samples are products distributed by
the company overseas, while others are samples of competitor's products
or samples of food or food ingredients made by foreign companies who
would like to do business with the U.S. company. When the samples are
intra-company, the registration number can be obtained, but the burden
to submit a prior notice, individually, for every one of these products
is excessive. Further, when the sample is a competitor's product,
access to the registration number is ordinarily not possible. In
addition, if the sample is from a company not doing business in the
United States, the company is not required to register its facilities
and thus does not have a facility registration number.
FDA must provide some relief for the importation of samples. The
routine importation of small quantities of food product samples simply
does not present major food security issues. Prior notice is intended
to assist FDA in allocating resources to examine and inspect
potentially high risk shipments of food. We do not believe that FDA
should devote its limited resources to the routine examination of food
product samples. Easing the prior notice burden for product samples
would help to ensure that food companies do not have to relocate
product analysis facilities outside the United States (to avoid the
expense and hassle of filing notices for every sample or dealing with
the problem of filing notices where registration numbers are not
available). FDA should develop a category for which a registration
number is not required such as sample products that will not be
consumed by the general public or that are not intended for retail
sale.
The second rulemaking of particular concern is recordkeeping. Under
the Bioterrorism Act, FDA is authorized to require the maintenance of
records of food to show the immediate person from whom the food was
received and the immediate person to whom the food was distributed.
These records are intended to assist FDA in tracing the movement of
food in the event of a serious problem involving that food. FDA issued
proposed recordkeeping regulations on May 9, 2003. Final regulations
are expected to be published soon.
In the recordkeeping proposal, FDA proposed to require that food
companies maintain records that included lot or production codes for
product delivered to retail stores. GMA has vigorously objected to this
proposed requirement as contributing nothing to food security while
being incredibility time consuming and burdensome. We have urged FDA to
remove this requirement from the recordkeeping regulation. A copy of
GMA's comments is included with my testimony.
The delivery of food to retail stores occurs in various ways. A
growing number of food companies use so-called direct store delivery.
In direct store delivery, the food manufacturer delivers product to the
retailer using company vehicles and employees. You have all seen GMA's
member company trucks at your local grocery store--these are direct
store companies. The delivery employees not only deliver the food to
the store, but restock the shelves--removing older product and
replacing it with new. It would be virtually impossible for these
employees to capture the lot or production code on each bottle or can
of beverage or each container of snack foods as they stock the shelf.
Importantly, this information is of little value to FDA. If there
is a problem with a particular food, the manufacturer will remove all
of the potentially offending food from distribution until the magnitude
and scope of the problem is determined. Retailers will do the same.
Thus, knowing that a particular product of concern with a particular
lot number was delivered to a specific retailer is not only extremely
difficult to obtain, but of little value.
We very much hope that in the final recordkeeping regulation FDA
will remove the ill-advised proposed requirement for lot and production
codes.
Mr. Chairman and Members of the Subcommittee, we welcome your
oversight. With the consolidation of the USDA Animal Plant and
Inspection Services and Customs from Treasury into the Department of
Homeland Security, our companies have been experiencing delays,
inconsistent enforcement of rules and confusion at the ports of entry.
With the implementation of the bioterrorism regulations, we are
concerned that these problems will increase. Additional resources may
be needed at the borders and we encourage your continued oversight.
I would be pleased to respond to any questions you may have. Again,
GMA thanks the Subcommittee for convening these hearings.
Mr. Bilirakis. Thank you very much, Ms. Stout.
Mr. Saunders, please proceed.
STATEMENT OF R. DOUGLAS SAUNDERS
Mr. Saunders. Thank you, Mr. Chairman.
Although I am an employee of the Virginia Department of
Agriculture and Consumer Services, I am here today as a
representative of the Board of Directors of the Association of
Food and Drug Officials.
For 108 years, AFDO has served as a major voice for food
safety officials in the United States and Canada. AFDO proudly
represents State and local government food safety officials at
public meetings or briefings where consensus opinions or
official comments are presented on a host of food safety and
security issues.
Today more than ever, there is a call for unity among
health officials in government and all levels and the need to
coordinate all available food safety and security resources,
particularly those at the integral nodes of our detection
system. From that perspective, we would like to offer the
following comments relative to the Bioterrorism Act.
AFDO fully supports the FDA as they implement regulations
under the Bioterrorism Act. Prior notification of incoming
shipments of imported foods and registration of food
establishments are absolutely imperative if we are to have any
ability at all to effectively control the movement or
distribution of foods that are suspected of being compromised
through acts of terrorism. We believe that such requirements
provide the basis for having greater control of suspect foods
and will enhance the capability to more quickly detect
nonintentional or intentional adulteration and facilitate
immediate removal of suspect food from the channels of
commerce.
Early detection and rapid response are essential elements
to defend the integrity of our food supply. Prior notification
and establishment of registration can only improve those
elements. However, we also believe that these components of the
Bioterrorism Act must be augmented by additional measures. With
imported foods, FDA must do more. The concept of evaluating the
safety of imported foods solely at one of the 400 border points
is inadequate in our view. FDA needs to move back the borders
to the manufacturing site and perform inspections of those food
establishments to significantly enhance our ability to detect,
detain and ultimately remove from commerce intentionally
adulterated foods.
Currently, such inspections only take place with respect to
low-acid canned foods. This authority must be expanded to cover
all food manufacturers located outside of our borders that ship
the food products into the United States. In addition, FDA must
work closer with State and local government agencies relative
to imported foods that are distributed domestically.
Some may suggest that imported foods are a regulatory
concern for Federal Agencies alone. These individuals would be
wrong. Once imported food gets through the scrutiny of our
Federal partners, they become primarily the concern of State
and local regulatory agencies. Many States report recalls of
imported foods, and the food seizures and embargoes are
commonplace for issues that include undeclared allergens,
unapproved color additives, undeclared preservatives and
pathogens. FDA must develop a means for obtaining this
information and utilizing it where appropriate to institute
import alerts.
FDA must also consider how to best use State and local
laboratory resources as well. The recordkeeping requirements
provided by the Bioterrorism Act certainly improves the
likelihood that effective trace-backs, trace-forwards or
recalls will be facilitated in the event of a terrorist attack
against our food supply. Improved trace-back, trace-forward or
recall capabilities will significantly enhance the expeditious
tracking and removal activities of the FDA when adulteration is
detected. It must be noted, however, that, historically, trace-
back or trace-forward activities are usually performed by State
food safety agencies. It is safe to assume that with the
limited resources that are available to the FDA, most trace-
back and trace-forward activities will continue to be performed
by the States in cooperation with FDA.
Administrative detention is a tool that FDA has needed for
many years and a tool that will provide immediate results when
it becomes necessary to prevent further distribution of suspect
food products. Prior to the granting of this authority by
Congress, FDA had to request States to detain, seize or embargo
food products when suspect food products were encountered.
Through cooperative agreements, FDA has utilized the State's
detention authority for many years.
Because the Bioterrorism Act contains the specific
requirements when FDA can utilize administrative detention, it
will still be necessary for FDA to maintain these cooperative
agreements with the States to ensure that suspect foods that do
not meet the Federal definition but are still of considerable
concern relative to adulteration continue to be legally
restrained. Consequently, through the FDA's new detention
authority and through continuing cooperative agreements between
FDA and the States, the nationwide network of detention
capabilities will be substantially strengthened.
For as long as FDA has existed, the cooperative
relationship between the FDA and State and local food safety
agencies have worked very effectively in protecting our
Nation's food supply. These coordinated activities have led to
a maximized utilization of Federal, State and local food safety
and security resources while eliminating the duplication of
food protection activities.
Through these cooperative efforts, State and local food
safety agencies have been able to supplement the food safety
and security activities of the FDA. In 2002, AFDO conducted a
survey of State activities that showed that, during 2001, State
programs performed more than 2.5 million inspections of food
establishments, more than 3,000 food-borne illness
investigations and investigation of over 46,000 consumer
complaints, response to over 2,800 emergencies, more than
128,000 enforcement actions, and collection and analysis of
over 328,000 food samples.
Based on these figures, more than 80 percent of the food
safety and security activities in the United States are
performed at the State or local levels. Consequently, it is
clear that State and local food safety programs provide the
major portion of the shields that must be in place to detect
any sort of terrorist act. With the increasing threat of
terrorist activities against the food supply, it is paramount
that this cooperative and highly integrated State, local and
Federal food safety and security system be maintained and
strengthened for the deterrence, prevention and detection of
terrorist activities.
With that focus, AFDO would like to call attention to a
piece of Federal legislation that threatens----
Mr. Bilirakis. Summarize it though, please.
Mr. Saunders. H.R. 2699, the National Uniformity For Food
Act of 2003, as presently cast undermines our Nation's whole
bio-surveillance system by preempting and invalidating many of
the State and local food safety laws and regulations that
provide the necessary authority for State and local agencies to
operate food safety and security programs.
We feel that you need to be aware of our concerns with
respect to that legislation and that the cost to the FDA to
replace the infrastructure and food safety and security
activities currently accomplished at State and local levels is
estimated to exceed $500 million.
In conclusion, the Bioterrorism Preparedness and Response
Act of 2002 is an immeasurably important and necessary law that
further solidifies our Nation's food safety and security system
by providing FDA with much needed and long overdue authorities.
However, the new FDA authorities can only remain effective if
these cooperative relationships between the FDA and State and
local food and safety security programs can be maintained and
improved. Consequently, for the effectiveness of the
Bioterrorism Act to be fully realized, it is absolutely
imperative that our current food safety and security programs
at all levels remain fully functional and active.
Once again, thank you very much for the opportunity to
provide these comments.
[The prepared statement of R. Douglas Saunders follows:]
Prepared Statement of R. Douglas Saunders, Chair, Food Security Task
Force, and Betsy Woodward, Special Advisor to the Board of Directors,
Association of Food and Drug Officials
Mr. Chairman, and members of the Committee, I am here today as a
representative of the Board of Directors and a past president of the
Association of Food and Drug Officials (AFDO), to provide testimony on
the importance of the Bioterrorism Preparedness and Response Act of
2002 (hereinafter referred to as the Bioterrorism Act). I would like to
thank you for this opportunity to share the perspective of AFDO on an
issue that is so vital to the protection of the food and agriculture
critical infrastructure of our nation.
For 108 years, AFDO has served as a major voice for food safety
officials in the United States and Canada. AFDO proudly represents
state and local government food safety officials at public meetings or
briefings where consensus opinions or official comments are presented
on a host of food safety and security issues. Today, more than ever,
there is a call for unity among health officials in government at all
levels and the need to coordinate all available food safety and
security resources, particularly those at the sentinel nodes of our
detection system. From that perspective, we would like to offer the
following comments relative to the Bioterrorism Act.
With respect to the four major issues addressed by the Bioterrorism
Act, AFDO fully supports the U.S. Food and Drug Administration (FDA) as
they implement regulations to address those provisions. Specifically,
those provisions include:
Prior notification of imported foods coming into the United States;
Registration of food establishments;
Record keeping to ensure effectiveness of tracebacks, traceforwards
and recall activities; and
Administrative detention of food products.
Prior notification of incoming shipments of imported foods and
registration of food establishments are absolutely imperative if we are
to have any ability at all to effectively control the movement or
distribution of foods that are suspected of being compromised through
acts of terrorism. We believe that such requirements provide the basis
for having greater control of suspect foods and will enhance the
capability to more quickly detect non-intentional or intentional
adulteration and facilitate immediate removal of suspect foods from the
channels of commerce. Early detection and rapid response are essential
elements to defend the integrity of our food supply. Prior notification
and establishment registration can only improve those elements.
However, we also believe that these components of the bioterrorism act
must be augmented by additional measures. With imported foods, FDA must
do more. The concept of evaluating the safety of imported foods solely
at one of the 400 border points is inadequate, in our view. FDA needs
to move back the borders to the manufacturing site and perform
inspections of these food establishments to significantly enhance our
ability to detect, detain, and ultimately remove from commerce
intentionally adulterated foods. Currently, such inspections only take
place with respect to low-acid canned foods. This authority must be
expanded to cover all food manufacturers located outside of our borders
that ship food products into the United States.
In addition, FDA must work closer with State and Local government
agencies relative to imported foods that are distributed domestically.
Some may suggest that imported foods are a regulatory concern for
federal agencies alone. These individuals would be wrong. Once imported
foods get through the scrutiny of our federal partners, they become
primarily the concern of State and Local regulatory agencies. Many
states report recalls, and food seizures or embargoes are commonplace
for issues that include undeclared allergens, unapproved color
additives, undeclared preservatives, and pathogens. FDA must develop a
means for obtaining this information and utilizing it, where
appropriate, to institute import alerts. FDA must also consider how to
best use State and Local laboratory resources, as well.
The recordkeeping requirements provided by the Bioterrorism Act
certainly improve the likelihood that effective tracebacks,
traceforwards, or recalls will be facilitated in the event of a
terrorist act against our food supply. Improved traceback,
traceforward, or recall capabilities will significantly enhance the
expeditious tracking and removal activities of the FDA when
adulteration is detected. It must be noted, however, that historically,
traceback or traceforward activities are usually performed by State
food safety agencies. It is safe to assume that with the limited
resources that are available to the FDA, most traceback and
traceforward activities will continue to be performed by the States, in
cooperation with the FDA.
Administrative detention is a tool that FDA has needed for many
years, and a tool that will provide immediate results when it becomes
necessary to prevent further distribution of suspect food products.
Prior to granting of this authority by Congress, FDA had to request
States to detain, seize or embargo food products when suspect food
products were encountered. Through cooperative agreements, FDA has
utilized the States' detention authority for many years. Because the
Bioterrorism Act contains specific requirements that define when FDA
can utilize administrative detention, it will still be necessary for
FDA to maintain these cooperative agreements with the States to ensure
that suspect foods that do not meet the Federal definition but are
still of considerable concern relative to adulteration, continue to be
legally restrained. Consequently, through the FDA's new detention
authority, and through continuing cooperative agreements between FDA
and the States, the nationwide network of detention capabilities will
be substantially strengthened.
For as long as FDA has existed, the cooperative relationships
between the FDA and State and Local food safety agencies have worked
very effectively in protecting our nation's food supply. These
coordinated activities have led to a maximized utilization of Federal,
State and Local food safety and security resources, while eliminating
the duplication of food protection activities. Through these
cooperative efforts, State and Local food safety agencies have been
able to supplement the food safety and security activities of the FDA.
In 2002, AFDO conducted a survey of state activities which showed that
during 2001, state programs performed:
More than 2.5 million inspections of food establishments;
More than 3,000 foodborne illness investigations;
Investigation of over 46,000 consumer complaints;
Response to over 2,800 emergencies or disasters involving food
products;
More than 128,000 enforcement actions, including, but not limited to,
embargos, seizures and stop sales; injunctions; criminal
prosecutions; warning letters; informal hearings; and food
recalls; and,
Collection and analyses of over 328,000 food samples, including more
than 252,000 microbiological samples.
Based on these figures, more than 80% of the food safety and
security activities in the United States are performed at the State or
Local levels. Consequently, it is clear that State and Local food
safety programs provide the major portion of the shields that must be
in place to detect any sort of terrorist act. With the increasing
threat of terrorist activities against our food supply, it is paramount
that this cooperative and highly integrated Federal, State and Local
food safety and security system be maintained and strengthened for the
deterrence, prevention and detection of terrorist activities. With that
focus in mind, AFDO would like to call attention to a piece of Federal
legislation that threatens to eviscerate this system. The ramifications
of this bill, intended or not, will dissolve our nation's biodefense
capabilities.
H.R. 2699, the National Uniformity for Food Act of 2003, as
presently cast, undermines our nation's whole biosurveillance system by
preempting and invalidating many of the State and Local food safety
laws and regulations that provide the necessary authority for State and
Local agencies to operate food safety and security programs. The pre-9/
11 concept embodied in this bill is very much out of line with current
threats that confront our food safety and security system. Preempting
and invalidating State and Local food safety and security activities
will lead to serious ramifications that will be difficult, if not
impossible, for our nation to recover from. Specifically, FDA's ability
to detect, much less respond, to acts of terrorism will be severely
hampered. The cost to the FDA to replace the infrastructure and food
safety and security activities currently accomplished at the State and
Local levels is estimated to exceed $500,000,000. Our current food
safety and security system will be significantly disrupted for many
years to come, and our inability to track suspected acts of intentional
adulteration will be exploited by those who seek to do harm to our
nation. Passage of H.R. 2699, in its current form, which would
invalidate State and Local food safety laws and regulations, will
effectively eliminate our nation's food biosecurity shields, and will
undermine our whole, food safety and biosurveillance capability.
In conclusion, the Bioterrorism Preparedness and Response Act of
2002 is an immeasurably important and necessary law that further
solidifies our nation's food safety and security system by providing
FDA with much needed, and long overdue authorities, and it ensures the
continuing, cooperative efforts of State and Local agencies. However,
these new FDA authorities can only remain effective if these
cooperative relationships between the FDA and State and Local food
safety and security programs can be maintained and improved.
Consequently, for the effectiveness of the Bioterrorism Act to be fully
realized, it is absolutely imperative that our current food safety and
security programs at all levels remain fully functional and active, and
that we continue to seek ways in which we can strengthen this highly
integrated and cooperative system.
Once again, thank you for this opportunity to provide our comments.
Mr. Bilirakis. Thank you Mr. Saunders.
First, I would say, in 5-plus minutes, I know it is very
difficult or impossible to present your point of views
adequately. And so, you know, I truly invite you to complement
your oral remarks and your written statement with any
additional comments to us.
We all want the same thing, I like to think, and that is
concern for the health and safety of our fellow Americans. And
if we are going to make any mistakes, if we are going to err,
it should be on the side of health and safety, I would think.
At the same time, we ought to be concerned about
reasonableness and practicality and that sort of thing. What do
you expect from the Congress? What do you expect from us? Mr.
Cady?
Mr. Cady. Well, I think legislation that was passed is now
getting to the point where the rubber meets the road. And while
we have worked very closely with FDA and I think we have made
great progress in terms of looking at their regulations and
they have been forthright in dealing with industry on this, but
I think it is an opportunity for us to be able to inform you as
to how this legislation is progressing in terms of
implementation.
And now, we are reaching some of the areas where
practicality, in terms of doing commerce, are being affected,
and I think each of us in our own way has explained what that
is.
Mr. Bilirakis. And you have all done a great job,
particularly in a short period of time.
Mr. Cady. We are dealing with the regulatory process, and
we just want FDA to reconsider a lot of the areas that we
raised today, I believe, and to see if there are workable ways
to achieve what needs to be achieved without affecting commerce
in a manner that is not only not economical, but is just
unreasonable in some areas.
Mr. Bilirakis. You would suggest, what, a delay in the full
enforcement date?
Mr. Cady. I think the enforcement date is going to be an
interesting day. And we have talked about percents of
inspections this morning. And I think we really--it hasn't
happened yet. And if we are worried about it now, I am not sure
what is going to happen on the 12th or the 13th. I am not sure
we need a time postponement here, but as I talk with Secretary
Thompson and FDA Commissioner McClellan at the time and I said,
you know, on the 13th, we can't have all of the trucks in the
world stopped at the border.
The food industry has got to continue. And I think it is a
matter of using common sense and practical approaches trying to
get through the first months of this new process and procedure.
It has got to start some time, Mr. Chairman.
And I just think it behooves FDA to understand that a
practical approach and common sense is going to be the way they
enforce this in the beginning.
Mr. Bilirakis. You said it well.
Do you all have something very significant to add to it.
Mr. Clarke. I would like to add that August 12, the penalty
phase of the Bioterrorism Act is also being implemented. And I
think the Agencies ought to devote more resources to protecting
the citizens of the United States rather than being an
enforcement Agency in penalty situations.
There has been little feedback coming back to the
industries on really how the system is working, what its flaws
are, how to address it. We all have concerns that, come August
12, there could be serious impact economically and physically
on our infrastructure. Can we say categorically this will
happen? No. But we are assuming, without some feedback from the
Agencies on where our problems lie and how to address them,
there is no way we can address those in an adequate time before
August 12.
We would ask the Congress to consider postponing the August
12 penalty phase of it, at least until such time as industry
can adjust to the proper requirements based on our hope of an
advanced educational program.
As far as brokers are concerned, being the front line, we
are finding a lot of operational programs that are not being
addressed properly.
Mr. Bilirakis. Is there--forgive me for interrupting, is
there a specific date? Might you not come back?
Mr. Clarke. We would like to see the program put into
effect so we have feedback for a 6-month period and then open
it up again for another 60-to 90-day comment period by trade.
We want to work with the Agencies as best as we can.
The system itself right now is slightly flawed. It is not
something that needs to be thrown out and started over. We need
to make sure this isn't going to impede international trade and
defeat the very purpose that it was put into.
Mr. Bilirakis. As I understand it, the staffs, Mr. Ford
from the other side and on down from our side and I am not even
going to try to pronounce his name, have been working really
earnestly on this together to have a meeting of the minds. I
would hope that we are not talking here an either/or kind of a
thing, as I said earlier to Mr. Brown, that there must be
something in between that can be done, that can be helpful and,
at the same time, be consistent with our concern, all of our
concerns, regarding the health and safety of our consumers.
Having said that, I yield to Mr. Brown.
Mr. Brown. Thank you, Mr. Chairman.
Testimony from a number of you mentioned concerns with the
prior notice requirement. Couple of them certainly sounded like
they could be addressed administratively.
Mr. Clarke, if I could start with you. You mentioned, under
current regulations, if a shipment is refused entry because of
a problem with prior notice submission, FDA informs the carrier
about the problem and not the person who submitted the prior
notice. Looks to me like the law is silent on the question of
whom should be informed. I don't know whether FDA has made the
right call on that, but it sounds like that is an example of an
issue that could be addressed administratively. Is it true that
we could resolve that?
Mr. Clarke. Yes, that is correct. Just the comment that I
put in there of switching the date from arrival to entry would
solve many of these operational problems, and it is something
the committee may wish to consider. It does not jeopardize the
security of the cargo. It is under Customs and Border
Protection's full authority. Cargo cannot move forward, entry
cannot be made.
Again, it does alleviate some of the penalty situations and
devote more resources to actually looking at the goods and
determining what is admissible and not admissible, rather than
trying to penalize legitimate food importers.
Mr. Brown. Mr. Cady, give me your read, if you would. FDA
requires that a prior notice submission include the
registration number for the facility that produced the product.
This goes beyond what the law requires. Would you give us your
comments on that and the ability for the Agency?
Mr. Cady. We are talking, I think, about registration
numbers, companies registering obviously. If I could say about
the 400,000 facility number that we have talked about at this
point--I think that is a high number--and as FDA has gone
through these regulations and exempted certain facilities, I
think that number becomes lower.
And so, not knowing what the final number is, I do believe
though we need to obviously have more education and overt
action on the part of the Agency relative to making sure that
companies know they have to register, and that is going to take
time, sir.
Now, as far as the lot production number for traceability
or whatever use we were talking about earlier, today, as I
stated, you know, when we have a problem with a product, let us
say it is, I don't know, a carrot product, as an example, you
go in and remove all of those--all of the product itself. You
don't look at lot numbers or purchase order numbers. You take
it all off the shelf when there is a potential issue or a known
issue. That is an easy way to do it and it is an awful lot
more--it is a quicker way, I should say, to do it.
And the statute does--the statute does give manufacturers
flexibility relative to how to account for these products. Now,
again, the lot product is not the way to do it, the way in
which FDA has proposed because, as my friend down the road here
said, the lots get mixed up--not mixed up, they are just--
yesterday's production is combined with tomorrow's production.
It is all put on a truck that stops and drops off potato chips
someplace. They are all commingled, and it is not an efficient
way to pull something back. So I think that there are ways to
do it, and we have a good system in effect right now for
recalls, and I think FDA ought to be using that as the premise
of their actions, sir.
Mr. Brown. Thank you, Mr. Chairman.
Mr. Bilirakis. Mr. Shimkus.
Mr. Shimkus. Thank you, Mr. Chairman.
I appreciate this hearing because it addresses, I think, a
lot of the concerns that many of us had moving into this
debate, homeland security and bioterrorism and food safety
issues, and then how to expeditiously move product to
processing to stores to tables and in a manner in which we know
is safe and sound, but also still efficient.
And what I am hearing, I think is that there is still an
unknown, what is going to happen in August. Is it safe to say
that--and, of course, when there is an unknown, that raises
stress, because we might not have problems, but we could very
well, because I am hearing there is a lack of communication as
far as what is going to be expected and what are, from the FDA,
especially with this and some of the things I mentioned in the
opening statement. Am I on the right track here?
Ms. Stout. If I could jump in here, I think the problem we
are trying to get at the interim final rules on prior notice,
the comment period closes July 13. The enforcement period
starts mid-August. But if FDA is going to listen to any of the
concerns that we have voiced in this, until they issue the
final regulation, which isn't inspected until next year some
time, we have no relief.
And some of the things that they are doing--Mr. Brown asked
the question here--the statute that was passed by Congress does
not require that a registration number accompany a prior
notice. That is a step beyond that the FDA has gone to and that
is creating problems for us because, in many instances, that is
not available.
Mr. Clarke. Along those same lines, I would like to add,
the way the regulations have been promulgated, it is based on
individual transmission for each line item that is being
transmitted into FDA. If you have a shipment coming in across
the border with multiple line items, any one of those items
could basically stop that shipment going forward. We do not
have information coming back from the Agencies, either Food and
Drug or Customs, in an adequate form for us to address if there
is a problem or if there is not a problem. That has to be
addressed before they can go into a final phase.
Mr. Shimkus. Did anyone address the issue of the
perishability of products and the time sensitiveness of going
across the border?
Mr. French. What we have experienced in some border
crossings involves the FDA's indicating that they would like to
sample product or taking their time to make a sampling
decision. And when you are dealing with perishable product that
has been slowing the process of crossing.
Mr. Shimkus. I know, in homeland security aspects, I know
what we are trying to do with immigration issues is push our
perimeter out. If we can get a good certification and
evaluation of the processing facility that is going to be
imported from, then, in essence, label that product as safe
once it leaves, then you should be able to expeditiously move
it through the border crossing. Is that what I am hearing?
Mr. French. I believe FDA guidance that predates 9/11
suggested that companies that are purchasing product know their
suppliers and that measure of assurance, knowing who you are
buying from, is certainly one of those things.
Ms. Stout. That is one of the things that GMA has done. We
have sister trade associations around the world, and we have
been telling them, from the beginning, ``Heads up, this is
coming. This is what you are going to need to do to comply. You
have to register. You can't get in the country.''
You talked about the perishable. One of the things--and I
think it has to do with the resource issue--is that there is a
Customs inspector at the border at all times. There is not an
FDA inspector. And what we are running into is, some of our
products that are coming in--and an example is yeast, which
doesn't stay a long time. If it arrives, you know, at 7 o'clock
on a Friday night at the Canadian-American border and Customs
allows it in because the prior notice is complete but he can't
release it until an FDA inspector approves it and that may not
be until noon on Monday, that truck of yeast is gone.
Mr. Clarke. We are experiencing a situation, if you are
using the Food and Drug prior notice system interface which has
limited capacity, there is no direct link between that system
and the custom system as far as the inspection arrival of the
cargo. A hard copy piece of paper has to be presented by the
carrier to the Customs inspector at that time, circumventing
all automated systems that are in place. It is not a very
effective system and needs to be revised and looked at.
Mr. Cady. If I could add one thing, sir. In teaching the
regulations as they stand today around the world, our
organization has found--I mean if you go to Thailand and go to
Singapore and Vietnam and a lot of people that bring food into
this country, you have to understand what they are thinking and
what they are trying to understand. They don't know if they
have to register, and we are trying to explain it to them. They
don't understand the border issues they are going to run into.
And for fresh product that is coming in overnight, seafood,
et cetera, it presents a huge problem not only from a
communications perspective, but more of an understanding
perspective. So the industry has taken on an awful lot of this
in terms of going out and educating different suppliers and
partners around the world so this commerce thing that we have
is going to continue to flow when this all goes into effect.
And I think that is something very important.
One other thing that I could clarify, Mr. Brown's question
if I could, just a second, on prior notice, is that the
Bioterrorism Act doesn't require that. And more importantly,
FDA needs to look at how do we make this system work
efficiently and effectively right away. And the prior notice
does not add to that. And in many cases, we can't find the
registration numbers and the information needed to put on the
prior notice certification, especially from countries outside
of ours.
Mr. Shimkus. I want to thank the chairman for holding this
hearing.
I hope the FDA kept their staffer here. And I would
encourage them to get the stakeholders together, and let us
resolve some of these conflicts, and I yield back.
Mr. Bilirakis. Hopefully it can be solved among you. Let's
see.
Mr. Green.
Mr. Green. Thank you, Mr. Chairman. And again, I appreciate
you calling the hearing.
Mr. Clarke, your testimony expressed concerns about the
prior notice requirements and specifically the 5-day
requirement. The law actually says that prior notice can occur
more than 5 days and in advance, and the notice most be
received within that 5-day window. Does that clarification in
the law have any impact on the timing or your concerns about
the timing?
Mr. Clarke. The way the systems have been developed,
though, it is impractical to do it 5 days prior because of the
Customs and Borders protection requirements of transmission of
entries. The only alternative you have to do that is to go
through the interface system within the Food and Drug, which
has been proven to be very ineffective and very time-consuming.
Mr. Green. Well, do you think we need to change at all then
to----
Mr. Clarke. There is no risk of security that we can see by
extending that date beyond the 5-day requirement. In fact,
through the Customs Container Security Initiative, they are
actually screening merchandise and gaining information 24 hours
prior to the cargo being loaded on its conveyance to the United
States, which in turn gives them an even more adequate chance
to look at cargo and determine what is admissible and not
admissible.
Along the same line, there has to be some coordination and
harmonization between the two Agencies. A lot of data that is
being transmitted under that phase of security could also be
utilized by Food and Drug and making a prior determination on
spot checking, whatever needs to be done to protect the
consumer.
Mr. Green. Well, and I agree, and like I said, with an
international port and air cargo, it is important we have as
much coordination as we can. And that is why we might need to
look at changing the statutory law that gives them that
ability, along with other things that at our hearings and other
hearings we will have.
Mr. Saunders, your testimony indicates that more than 80
percent of the food safety activities are formed at the State
and local level, and we learned from our first panel that only
about 2 percent of the food imports are actually inspected, and
these inspections are based on the risk assessments. And from
your perspective, representing both State and local officials,
are you satisfied with the level of inspection at our borders?
And other than increased Federal, State and local coordination,
what can the Federal Government do to ensure that the food
safety entering our harbors? And have you shared your views
with the FDA and Customs? And I will just give a side line,
being to the border--in Texas--a number of times with Mexico, I
have found that our State border inspectors have a great deal
of information to share. And I would hope there is only about a
50-foot separation between them and Customs in some cases. I
would hope that there would be that information-sharing between
the local and State.
Mr. Saunders. There is significant information-sharing
between the local and States and the Federal partners. You
know, as far as the 2 percent coverage that the Federal
Government is able to provide with respect to imports now, AFDO
has believed for some time that that is not adequate and that
there are ways to deal with that.
Some suggestions that have been made are for the FDA to
focus more on import issues and rely on the States and
localities to handle the domestic issues. There are things,
such as memorandums of understanding with other countries, as I
mentioned during my presentation, some foreign inspections of
food establishments by FDA, and I think there are certainly
other ways that those issues could be addressed so that there
is a greater oversight of the products that are coming across
our borders.
Mr. Green. Okay. Now, I think, from the first panel and
knowing what is happening in my own area, I think a lot of that
is being done, but, again, hopefully, it could be systemic and
not just in certain ports, or it would be all through the--all
around the country.
Mr. Saunders. Yes, sir.
Mr. Green. Mr. Chairman, I appreciate the time.
Mr. Bilirakis. Mrs. Capps.
Mr. Clarke. Might I add to that just one brief comment to
that also? We have a layered approach to the security in this
United States. We have Customs and Border Protection, who are
doing quite a good job of screening cargo coming in through
risk analysis. Even though you may say 2 percent is only being
looked at, technically every single piece of merchant cargo
coming into the United States, whether it be food products or
consumer products, is actually being screened by Customs and
Border Protection under the risk-analysis procedures.
Mr. Green. And Mr. Chairman, I know I have taken my time,
but I know that is true with the container for general cargo,
too, that you are using the law enforcement techniques. You
know, we are doing it. But I think our goal is to increase
those percentages.
Mr. Cady. Mr. Chairman, Mr. Green, if I could just say one
thing. We have--we talk about the borders and things come into
the borders, but remember, we do a lot of food production
within this country. And there are food safety systems in
effect and food security systems in effect that compliment the
border and the FDA and the AFDO and all the rest of the
inspectors that we deal with.
And these food safety and food security systems, we spend
millions and millions of dollars on ourselves protecting our
brands and our food so there is a lot being done by the
industry itself in addition to what these regulations----
Mr. Bilirakis. Can you share some of that information with
us?
Mr. Cady. I will be happy to, sir, and can I provide that
for the record for you?
Mr. Bilirakis. Yes. If you could provide that for the
record for us we would appreciate that very much.
Mr. Cady. Be happy to do so sir.
Mr. Bilirakis. Thank you.
Mrs. Capps.
Mrs. Capps. I thank you, Mr. Chairman.
And according to your testimony, Mr. Saunders, the H.R.
7699--2699, sorry, whichever it is, 2699 would have quite an
impact on State food and safety regulations and even on our
Nation's efforts to secure our food supply. This is the
National Uniformity For Food Act.
In my home State of California, as you may well be aware,
we have very vigorous food safety and labeling laws which leads
me to be very concerned about this legislation, and from your
testimony, it sounds like this bill, if enacted into law, would
really gut California safety laws. Is that true? And would you
comment briefly?
Mr. Saunders. AFDO has been following that legislation for
quite some time, and we have done an awful lot with respect to
trying to educate States and localities about the language in
that legislation. We have met with attorneys who have reviewed
the legislation. We have had numerous States--and I believe the
most recent count there were 12, are 12 States--that have had
their attorneys look at that legislation. And they have all
agreed that there are some very gray areas in that legislation
that could have a very negative impact on these States and
localities' abilities to operate effective food safety and
security programs.
Ms. Capps. Well, you also, to make it more national in
scope, I would like you to expand on the kind of comments that
you made around the fact that this would be a national--it
would be costly to our Nation in effect because of the
interconnection between the State and Federal regulations. I
guess on how much--it simply said that the Federal Government
kind of relies on the States' enforcement, and therefore,
enacting this law would have--would affect our national budget
as well.
Mr. Saunders. Yes, we believe that it would. We--there is a
very cooperative integrated food safety and security system in
this country that involves Government Agencies at all levels.
And that system has been in place for years. It has been
improved upon for years, and if the States and localities lose
their authority to enforce their laws and regulations,
particularly with respect to adulteration--and when we are
talking about terrorism that is what we are talking about--then
the Federal Government is in a position to where they may have
to pick that amount of work up.
And based on the survey that we have done and the amount of
work that the States and localities are able to perform, it has
been estimated that it could cost the Federal Government $500
million to replace the infrastructure that already exists among
States and localities and to perform the number of inspections
that they currently perform.
Mr. Bilirakis. Would the gentlelady yield?
Mrs. Capps. I will yield. But let me understand, that you
see a direct connection to our terrorism readiness--I mean,
this bill is about security. And if we enacted the law, this
bill into law, and didn't make up for the cost, then we would
be jeopardizing our national security in food safety.
Mr. Saunders. Yes, ma'am.
Ms. Capps. I am going yield to the chairman.
Mr. Bilirakis. Let me just ask, Mr. Saunders, have you made
an effort to communicate with the authors of that legislation?
Mr. Saunders. Yes, sir.
Mr. Bilirakis. You have?
Mr. Saunders. Yes, sir.
Mr. Bilirakis. And have you discussed this with them and
your concerns?
Mr. Saunders. Yes, sir.
Mr. Bilirakis. AFDO's concerns? You have? So they are aware
of them?
Mr. Saunders. Yes, sir.
Mr. Cady. Could I just add something, and then I would like
to defer to my compatriot here, Ms. Stout?
Ms. Capps. Surely.
Mr. Cady. From the National Processors' perspective, we
have reviewed that legislation pretty in depth. And we don't
see the concerns that AFDO has expressed on that particular
part of the issue, on that particular part of the bill.
Mrs. Capps. Which part? Excuse me, because there are a few
different standards.
Mr. Cady. Well, I think there is a statement, ma'am, that
talks about, if the uniformity bill were to pass, that it would
destroy--or I am not sure the adjective being used--but it
would essentially----
Ms. Capps. Would impact.
Mr. Cady. Adversely, the State authorities relative to
their position.
Mrs. Capps. Right. But if one set of regulations is more
stringent and in depth or however you want to describe it and
there is a laxness or a lowering of the standards, it is going
to be----
Mr. Cady. Well, I don't think the standards are lowered.
Mrs. Capps. Well, then you disagree.
Mr. Cady. We disagree. But I would like to have Susan talk
about that.
Ms. Stout. Yes, if I just may comment. I mean, this H.R.
2699, if you read the legislation, it does not have any effect
at all on any State food inspection programs. It does not have
any effect on any enforcement authorities enjoyed by the
Federal, State or local.
The GMA has reached out since 1998, communicating with
those who had concerns about the issue, including AFDO. We--
there are many changes that were made to the provision, at
their request, to make sure that, once the bill is enacted,
there is a nice seamless cohesion that takes place. There is no
cost to the----
Mrs. Capps. Excuse me?
Mr. Bilirakis. The gentlelady's time is expired.
But look. That is a separate piece of legislation. It will
be subject to hearings. We will have the opportunity to go into
the pros and cons and that sort of thing. I don't think we need
to go any further.
Mrs. Capps. Well, I just want to--I know I have used my
time, but I did yield to you.
Mr. Bilirakis. Well, I took about 20 seconds. But go ahead.
Mrs. Capps. The Federal Government often looks at States
differently than States do, and I think, in the House, we sort
of try to juggle those sometimes competing, hopefully not
competing, interests, and I would--I believe we need to have
further discussion in this area.
Mr. Bilirakis. And we don't--I don't think we should be
predeciding on some of these things either. That is what
hearings are all about.
The gentlelady's time has expired.
All time has expired.
I want to thank you. I would ask, maybe, one final question
if I may. As against delaying the enforcement date from August
12 to a later date, is it--would it be reasonable--and I don't
want to take 5 minutes on this--but would it be reasonable--and
maybe you want to respond in writing--would it be reasonable
to--so there are some areas where maybe enforcement, immediate
enforcement, August 13 enforcement could or might take place,
and other areas that possibly maybe should remain in the
flexible enforcement category. Very, very quickly, though,
because I don't want to take much time on that.
Mr. Clarke. Yes, that is a possibility. But, again, the
systems that are in place do not give us that luxury to have
that. It requires, to be coming in on October 12, edits to be
turned on, systems to be shopped, shipments to be stopped at
that date, and I am not sure the Agencies have the capability
of extending, on a partial basis, either all or nothing. But
the Agencies themselves would have to address that.
Ms. Stout. I also think, Mr. Chairman, it would be
incredibly helpful if the Agencies could give us feedback on
what the problem has been with the prior notices that have been
submitted and have been----
Mr. Bilirakis. The Agency is right behind you.
Ms. Stout. They have been terrific.
Mr. Cady. Mr. Chairman, I think the thing that would be
most helpful would be to, perhaps, not implement the penalty
phase. I think that is probably the most important thing at
this point because of the need for understanding and, as I said
earlier, the need for a practical implementation of this.
The Agency and the Department of HHS have assured us, me,
that they will have a practical commonsense implementation. It
needs to start, but they need to be flexible until they,
themselves, understand what the impact of these regulations are
going to be on their workload as well as on commerce and the
Agencies' ability to do something. So I think those two
things--I don't think you win anything by pushing it down the
road 6 months. But I do think flexibility, which the Agency
does have, can be utilized and the penalty phase perhaps
implemented at a later date.
Mr. Bilirakis. Thank you, Mr. Cady.
Mr. Brown, anything further?
All right. This hearing--again, as I said earlier, any
further ideas or suggestions or recommendations or whatever, we
always will welcome them. It is important, the more information
we have available, the better job that we can do if we do
directly get involved as far as this area is concerned. Thank
you. The hearing is adjourned.
[Whereupon, at 12:03 p.m., the subcommittee was adjourned.]
[Additional material submitted for the record follows:]
National Food Processors Association
August 9, 2004
VIA Email
The Honorable Michael Bilirakis
Chairman
Subcommittee on Health
Committee on Energy and Commerce
U.S. House of Representatives
Washington, DC 20515-6115
Dear Chairman Bilirakis: I am writing to provide my responses to
the questions you transmitted in your July 26, 2004 letter, which
followed the June 25, 2004 hearing, ``Implementation of the Food
Security Provisions of the Public Health Security and Bioterrorism
Preparedness and Response Act.'' Please find my responses attached.
I again thank you for the opportunity to testify before the
Subcommittee. If you have any questions regarding the attached
responses to the Subcommittee's questions, please contact me.
Regards,
John R. Cady
Attachment
Response to Follow Up Questions
Question 1) I would like to ask each member of the panel what steps
their members have taken to help secure our food supply from
terrorists.
Response: The steps taken by members of the National Food
Processors Association (NFPA) to protect the food supply against
terrorist attack include renewed attention to existing food safety
measures and systems, such as Hazard Analysis and Critical Control
Point programs, Good Manufacturing Practices, product quality and
safety assurance programs, and ingredient/ingredient supplier
specifications and monitoring, that contribute to ensuring food
security has not been compromised. While each food company and facility
must tailor security measures to their unique situation, there are
clear trends in the actions being taken by NFPA members. As information
becomes available about possible threat agents, whether biological or
chemical, companies are evaluating how these agents may respond during
food processing and what measurement tools need to be developed for
rapid detection. Many companies are using relevant guidance, including
a manual prepared by NFPA and the Food Marketing Institute and general
guidance from federal agencies, to evaluate security vulnerabilities
with subsequent adoption of steps to mitigate or remove these
vulnerabilities. The types of actions include stringent access controls
to facilities, protocols for responding to suspected terrorist threats,
background checks as permitted on potential employees, and security
awareness training for employees. A growing number of companies are
pursuing formal security plans. NFPA is committed to helping in this
regard and is in a unique position among industry trade associations in
that a security and emergency response expert has been added to the
NFPA staff. The actions taken extend beyond security at company
facilities to include working with suppliers to ensure appropriate
security is in place throughout the supply chain. NFPA is facilitating
and encouraging information exchange among our members as we move
forward. However, specific plans and programs will continue to be kept
confidential to ensure security is not compromised.
In addition to the voluntary security initiatives taken by our
members, compliance with FDA's Bioterrorism Act rules is also a
priority. NFPA's members supported passage of the Act and continue to
recognize the importance implementation of the rules will have as part
of the needed industry/government partnership to enhance the security
of the U.S. food supply.
Question 2) I would like to ask the members of the panel about the
prior notice requirement, and whether you believe the system can be
fully operational by August, and what steps they would recommend to
make the system more workable.
Response: While NFPA believes functioning systems for receiving and
electronically evaluating prior notices will be operational by August,
concerns remain. The most recent FDA compliance summary released in May
2004 indicates that, as of April 2004, ``very few'' entries had no
prior notice. However, the FDA data shows there continues to be a large
percentage of the total of approximately 150,000 prior notices received
each month that would not be accepted under full enforcement of the
prior notice rule. FDA notes specific data elements most frequently
absent are carrier data and manufacturer's registration numbers. The
lack of carrier identity is most notable for arrivals by road, which
means shipments from Canada and Mexico. FDA's analysis concerns the
completeness of prior notices and does not include assessment of the
accuracy of the information provided, which makes it difficult to
determine what other clerical or processing problems may be occurring.
NFPA believes FDA's analysis indicates industry is making a good faith
attempt to comply with prior notice requirements. However, there is a
high likelihood of major disruptions at the Canadian and Mexican
borders if full enforcement begins in August.
NFPA's suggestions, which have been communicated in comments to
FDA, for steps that should be taken to make the system more workable
are:
1. The discretionary enforcement period should be extended to December
12, 2004 and targeted education programs should continue to
specifically address problems such as carrier data for cross
border trucks.
2. A solution must be identified to accommodate entry of samples for
research for which manufacturer's registration numbers cannot
be provided.
3. Time frames between Customs and Border Protection and FDA should be
integrated prior to the end of the discretionary enforcement
period.
4. The prior notice interface system should be simplified and better
technical assistance provided to submitters.
Question 3) Do you have a sense of what the registration compliance
rate is for your members?
Response: NFPA believes that all member company facilities that
clearly should be registered, such as processing facilities, have in
fact registered with FDA. NFPA advised member companies to register
facilities even if there was some uncertainty as to the applicability
of the registration requirement. It appears our members have responded
to this advice. NFPA continues to work with members to ensure
compliance, as FDA further refines its interpretation of the
registration rule, particularly with respect to facilities at which the
holding of food is a minor and incidental activity.
Question 4) What more can be done to educate industry on the need
to comply with the registration requirement?
Response: One of the most important steps FDA can and should take
in continuing to inform the industry about the facility registration
requirements is to respond in a timely way to questions that have been
posed to the Agency regarding the application of the rule. The response
needed from FDA is the timely update of the guidance provided in the
question and answers page that is published on the Agency's website.
This guidance helps companies directly as well as supports ongoing
education and assistance efforts such as those conducted by NFPA. While
FDA recently updated its facilities registration question and answer
document, only four questions were addressed during the six months
since the document was last updated. Many more questions remain.
NFPA also supports FDA's ongoing use of its current enforcement
policy, which emphasizes education, awareness, and allowing companies
to come into compliance, except in those instances when full
enforcement is needed. Under a flexible enforcement policy, FDA may be
able to identify sectors or categories of facilities that merit
targeted education efforts, either by the Agency or by industry. NFPA
anticipates a need for ongoing education efforts, particularly for
foreign facilities/companies.
Question 5) In your opinion how could the Food and Drug
Administration build upon companies' current record keeping regiments
and still meet the intent of the record-keeping requirement?
Response: The current record keeping regimens of food companies
should for the most part satisfy the intent of having ``one step
forward, one step back'' information available for the FDA under
circumstances where there is a threat to the food supply. Food
companies already have in place the ability to identify sources of food
and food ingredients in the event of a product tampering or product
recall. Within a company, business records (purchasing, sales and
distribution) as well as the manufacturing and inventory records are
sufficient to meet the requirements of the Act. We recommend that the
role for FDA be limited to verifying that food companies have
implemented such systems that reflect the nature of their businesses
and that food companies validate that such systems are functional and
effective. This verification and validation role for FDA will build
upon the food companies records systems and provide assurance that FDA
can obtain information quickly and efficiently to carry out
investigations in the most timely and comprehensive manner possible.
Question 6) Some have raised concerns that the lack of FDA
inspectors at every port 24 hours a day, seven days a week will lead to
shipments being unnecessarily delayed at the border. Do you believe the
December 2003 Memorandum of Understanding between the FDA and Customs
that allows Customs officials to inspect shipments when the FDA is not
present will eliminate this potential problem or are more steps
required?
Response: The MOU between FDA and Customs and Border Protection
(Customs) is critical to successful implementation of the prior notice
provisions of the Bioterrorism Act; every port must have adequate
coverage 24 hours a day, seven days a week. A larger concern is
potential back up consequences to shipments that are in compliance,
particularly to cross border truck traffic, when products are held or
diverted to secured storage. Accommodations must be made to move non-
compliant or questionable shipments quickly from traffic lanes. Like
Customs, FDA should facilitate trade for low-risk shippers.
Question 7) Your organizations have both raised concern over the
ability of companies to bring in competitive samples and how this
impacts the ability of companies to perform research and development in
the United States. Given that these products are usually bought at the
retail level your companies would not have access to the manufacturer
registration number. Have you voiced these concerns with the FDA, and
if so what has been their reaction?
Response: NFPA has shared industry concerns with FDA both through
written comments and in discussions with FDA officials. NFPA has
indicated that the statutory language allows FDA the authority to
provide an alternative solution that would identify the manufacturer
without the specific registration information. FDA has acknowledged
these concerns and has conveyed the view that: (1) FDA does not have
the statutory authority to provide an exception for samples; (2) FDA
requires the registration numbers to implement other provisions of the
Bioterrorism Act; and (3) samples could pose a ``risk.''
Question 8) Has either of your organizations provided the FDA
suggestions to address the problem of competitive sampling without
compromising the integrity of the registration and inspection system of
imported food products?
Response: Through comments filed on July 13, 2004, NFPA made the
following recommendation:
``Because the statute does not mandate a manufacturer's
registration number, a prior notice for food samples would be deemed
legally sufficient using any of the following alternative solutions:
FDA could provide an alternative prior notice in a simplified version
(that does not require manufacturer registration numbers) for
products that are shipped to the United States and not intended
for public consumption or sale;
The manufacturer's registration number could be replaced by other
identifying information such as the manufacturer's name and
address;
The manufacturer's registration number could be replaced by the
registration number of the importing manufacturer who is
ultimately responsible for the shipment and final use of the
product;
FDA could require registration numbers for either shipper or
manufacturer. This alternative would provide FDA with
information to enable enforcement of foreign facility
registration without imposing unnecessary and unobtainable
information burdens; it would also allow a U.S. manufacturer to
recall product to the United State when necessary without
unnecessarily registering a ``shipper'' or allow U.S. companies
to ship samples from sales offices abroad.
``At most, any of these alternatives would require only a simple
technology adjustment to identify a specific shipment category: samples
for research and development. The prior notice regulation could easily
be amended to accommodate this change merely by addressing food samples
as well as gifts in section 1.281(a)(6), to read as follows: If the
article of food is sent by an individual as a personal gift (e.g., for
non-business reasons) to an individual in the United States, or is
imported as a sample for research and development purposes, you may
provide the name and address of the firm that appears on the label
under 21 C.F.R. 101.5 instead of the name, address, and registration
number of the manufacturer.''
______
International Foodservice Distributors Association
August 9, 2004
The Honorable Michael Bilirakis
Chairman
Subcommittee on Health
Washington, DC 20515
Dear Mr.Chairman: Thank you for the opportunity to present
testimony before your panel on June 25, 2004, at the hearing titled:
``Implementation of the Food Security Provisions of the Public Health
Security and Bioterrorism Preparedness and Response Act.''
Attached you will find responses to your additional questions for
the record. Please feel free to contact me if you have any further
questions.
Thank you again for your consideration during my appearance before
the Subcommittee.
Sincerely,
David G. French
Senior Vice President, Government Relations
Attachment
Follow Up Questions
Question 1) I would like to ask each member of the panel what steps
their members have taken to help secure our food supply from
terrorists.
Answer: IFDA members consider the safety and security of their
products their most important responsibility. Companies in our industry
have taken a number of steps to safeguard facilities including (but not
limited to) fences, surveillance cameras, perimeter lighting, motion
detectors, card-controlled access points, background checks and photo
identification cards for employees. In addition, our companies strive
to purchase products from known suppliers.
Question 2) I would like to ask the members of the panel about the
prior notice requirement, and whether you believe the system can be
fully operational by August, and what steps they would recommend to
make the system more workable.
Answer: Our member companies have reported very few problems with
the prior notice requirement.
Question 3) How are recalls conducted in the foodservice industry?
How frequently do products need to be recalled?
Answer: Foodservice firms typically conduct one or two recalls per
month. A recall is conducted when a restaurant operator, a
manufacturer, or a distributor detects a health or safety issue.
Foodservice companies work with their supply chain partners to identify
the products involved and the dates the products were received and
shipped. Then, a distributor will manually check for lot numbers of
individual pallets and cases to verify that the correct products are
withdrawn from commerce. When there is any doubt regarding which
products are involved, companies err on the side of caution by
withdrawing more product than necessary.
Question 4) If lot numbers are not used to identify products, how
do operators and distributors know that they will remove the proper
items from commerce?
Answer: Distributors do not typically use lot numbers to track
product, because there is no standard format for lot number coding or
placement on products and cases. Also, many distributors receive
products on pallets that may contain four or more different lot
numbers. Instead, most distributors track products using purchase order
numbers. Lot numbers, however, can be useful in identifying specific
products to remove during a recall; but this process often requires
manual verification of lot numbers.
Question 5) Are UPC codes, or barcodes, used to track product?
Answer: Adoption of UPC codes is not widespread by foodservice
manufacturers. Recent product surveys have shown that less the eighty
percent of the cases in most foodservice warehouses carry a UPC code.
Barcodes are, however, very useful; and many distributors assign their
own internal system to products upon receipt so that these products can
be tracked and quickly located within the distributors' operations.
Question 6) Wal-Mart and the Pentagon have announced ambitious
plans to require their suppliers to use radio frequency identification
(RFID) tags to improve efficiency within their distribution channels.
What is the future of RFID in the foodservice distribution industry?
Answer: RFID is most likely the future for efficient warehouse and
logistics management, and the foodservice industry is enthusiastic
about the technology's promise. There are many hurdles to cross,
however, before RFID will be widely used within our industry. Cost of
the technology is one of the challenges. The chips are expensive,
costing roughly $0.55 each; so RFID presently offers the most promise
for high-value, low-volume products. Foodservice industry products,
however, are typically low-value and high-volume. The technology has
not yet been perfected, either. Tests of the current generation of
technology show a 95% ``read-rate.'' Since the cost of correcting
errors can be quite high, the foodservice industry strives for accuracy
rates that exceed 99.9%. As one example of the challenge of making RFID
work for our industry, readers have problems tracking tags through
metal and liquids, which are the packaging and contents of a large
number of food products. Until these bugs have been ironed out, it is
unlikely that most foodservice firms will experiment with the
technology. Finally, it is important to point out that Wal-Mart's
initiative will have little impact on foodservice distributors since
foodservice distribution and retail grocery distribution are separate
supply chains with few shared products.
Question 7) Mr. French, you said that the current time frame given
to companies to produce their records is too short. Why would companies
not be able to comply with the current time restraints? What would be a
more reasonable time frame?
Answer: Most companies can and do retrieve their records promptly,
but we remain concerned that the time is too short in view of the
potential penalties. In foodservice industry contractual arrangements,
for example, eight hours is the most common time allotted for record
retrieval.
Question 8) You mentioned your concerns with the Food and Drug
Administration's educational efforts on explaining why prior notices
are deficient. Do you have any suggestions on how FDA can improve in
educating industry on the information required and format of prior
notices?
Answer: It would be useful for FDA to communicate with prior notice
filers regarding what about their filed notices is deficient, and to do
so before the period of full enforcement begins. It is certainly
possible that prior notice filers, acting in good faith, but ignorance,
are making errors in their notices. Better information from FDA now
regarding deficiencies in filed prior notices will prevent needless and
burdensome compliance problems later. Also, we suggest that FDA reopen
the comment period on the prior notice rule after there has been a
period of active FDA/CBP enforcement. In this way, if there are
operational problems that arise once active enforcement begins, the
food import community and FDA/Customs will have a channel of
communication open to discuss and address these issues. This ``real
life'' experience will allow for informed comments on the true
workability of the prior notice rule. FDA would then issue a final
prior notice rule thereafter.
Question 9) Do you have a sense of what the registration compliance
rate is for your members?
Answer: We are not aware of any IFDA member that has failed to
register, nor are we aware of significant numbers of unregistered
companies among other foodservice industry firms. Since the
registration requirement was enacted, we have worked to educate our
members about the law. For example, IFDA staff members have presented
educational briefings at industry conferences to reach an audience
broader than our membership, and our association has invited senior FDA
officials to address industry meetings. Our association, however, only
represents the largest 130 companies of an industry that has been
estimated to be as large as 2500 firms.
Question 10) What more can be done to educate industry on the need
to comply with the registration requirement?
Answer: We have explored a variety of avenues to educate and inform
our industry about registration. Reopening the comment period after a
period of active enforcement might yield more information about non-
compliance and tools for reaching these firms.
Question 11) In your opinion how could the FDA build upon
companies' current record keeping regiments and still meet the intent
of the record-keeping requirement?
Answer: The goal of the record-keeping requirement is to enable the
FDA to quickly and efficiently manage a product recall. The law does
not require the FDA to reinvent the process, and there is no evidence
that the current system of voluntary, cooperative recalls has failed.
Question 12) Some have raised concerns that the lack of FDA
inspectors at every port 24 hours a day, seven days a week will lead to
shipments being unnecessarily delayed at the border. Do you believe the
December 2003 Memorandum of Understanding between the FDA and Customs
that allows Customs officials to inspected shipments when the FDA is
not present will eliminate this potential problem or are more steps
required?
Answer: It is too early too tell what problems will be experienced
when full and active enforcement is in effect. To date, our members
have reported few problems with imports. As discussed above, the
industry may benefit from an additional opportunity to submit comments
once there is experience with full enforcement.
______
Grocery Manufacturers of America
August 9, 2004
The Honorable Michael Bilirakis
Chairman
Subcommittee on Health
Committee on Energy and Commerce
2125 Rayburn House Office Building
Washington, DC 20515
Dear Chairman Bilirakis: Thank you again for the opportunity to
appear before the Subcommittee on Health on June 25, 2004, at the
hearing titled: ``Implementation of the Food Security Provisions of the
Public Health Security and Bioterrorism Preparedness and Response
Act.''
My answers to the additional Subcommittee questions are attached.
Please do not hesitate to contact me if you have additional questions
or needs on this issue. As I stated during the hearing, food security
is an all important issue to the Grocery Manufacturers of America and
we stand ready to assist your further actions in this area.
Thank you again.
Sincerely,
Susan M. Stout
Vice President, Federal Affairs
Grocery Manufacturers of America Response to Follow Up Questions
Question 1) I would like to ask each member of the panel what steps
their members have taken to help secure our food supply from
terrorists.
Response: With over 140 members, GMA is sure you appreciate that we
can't provide an exhaustive list of all the steps our members have
taken. In general, they have revisited their physical security programs
for plants, warehouses and other facilities; reviewed and upgraded
where necessary traditional food safety, GMP and HACCP programs, from
receipt of raw materials through processing, packaging and
distribution; and have reemphasized employee screening and relations
with suppliers, distributors and customers. Our members have also
worked through GMA in at least three areas. First, in November 2001 GMA
established Project Vigilance which collected from and provided to
members best practices in the area of food defense and security.
Second, with FMI (Food Marketing Institute), GMA has established Food
Elert, a password-protected web-based system with which security
experts from food manufacturers and food retailers can better
communicate with each other in emergencies, and which GMA uses to
provide information from DHA, FDA and USDA in a restricted way to
members' food security experts alone. Lastly, at our members' request,
GMA has been actively engaged in the Food Industry ISAC since February
2002, and more recently in the development of the Food and Agriculture
Sector with DHA, FDA and USDA.
Question 2) I would like to ask the members of the panel about the
prior notice requirement, and whether you believe the system can be
fully operational by August, and what steps they would recommend to
make the system more workable.
Response: GMA has grave concerns about results if the prior notice
system becomes fully operational in August of 2004. Although FDA has
operated the prior notice system since December in an ``educational''
mode, companies that submit prior notices have not received from FDA
specific feedback on notices. Thus, it is difficult, if not
impossible--even for a company that is most dedicated to compliance--to
know whether the prior notices that it has submitted over the last
eight months comply with FDA's requirements and expectations. We are
concerned that if full compliance begins in August, companies will only
then learn about problems with prior notice and products will be denied
entry. We suggest that FDA extend the educational phase of prior notice
compliance and create a mechanism to provide feedback to prior notice
submitters that is specific individual notices.
Question 3) Stout, what are the biggest problems you envision with
the prior notice rule?
Response: The biggest problems with the prior notice rule will flow
from FDA's insistence, at least thus far, on requiring the facility
registration number to be a part of prior notices. As I explained in my
testimony, registration numbers are not always available to persons
legitimately importing products. For example, many GMA member companies
routinely import samples--competitor's products or potential new
ingredients--produced in facilities where the registration number is
either not available or where the facility is not required to register.
Requiring the registration number as part of prior notice--something
that the Congress did not specify--will impede importation of samples
and create a powerful incentive for companies to relocate R&D
facilities to locations outside the United States. FDA could easily
solve this problem by eliminating the requirement for the registration
number for shipments of samples and in other instances in which it is
not reasonably available.
Question 4) What are you most concerned about with regard to record
keeping?
Response: FDA has proposed to require that lot or production codes
be included in records to be maintained under the recordkeeping
regulation. It is neither practicable nor necessary for records to
include lot or production code information. When foods are delivered to
retailers, the delivery persons do not have the capability to capture
the lot or production code information as store shelves are stocked and
restocked. Moreover, this information is not reasonably needed by
manufacturers or by FDA. If problems arise with a product that
necessitates its removal from distribution, manufacturers and retailers
will remove all products, not just the product with the offending lot
or production codes. It is simply more efficient to remove all of a
product from distribution than to laboriously review the lot or
production code on each product and to remove only those at issue. FDA
should eliminate the requirement for lot or production codes as part of
the bioterrorism recordkeeping regulation.
Question 5) Are FDA and Customs doing a good job of coordinating
with one another?
Response: Coordination between FDA and Customs is markedly
improved. There is still ample room for improved coordination. In
addition, there remain some instances in which FDA prior notice
requirements and Customs notice requirements are not compatible. The
agencies should work to eliminate those inconsistencies.
Question 6) Do you have a sense of what the registration compliance
rate is for your members?
Response: GMA is confident that its members are fully aware of the
registration requirement and in compliance with it. GMA has devoted
considerable resources to providing educational materials and advice to
its members on registration and other bioterrorism requirements.
Question 7) What more can be done to educate industry on the need
to comply with the registration requirement?
Response: It is difficult to suggest specific educational
initiatives that would be likely to increase the registration rate
without the benefit of an analysis of the registration database as
compared to what FDA expected. We understand that far fewer facilities
have registered than was assumed would be the case, but we do not know
whether that is because the initial assumptions were faulty or because
there are large numbers of facilities that are subject to the
registration requirement, but which remain unregistered.
Question 8) In your opinion how could the FDA build upon companies'
current record keeping regiments [sic] and still meet the intent of the
record-keeping requirement?
Response: Under the FDA recordkeeping proposal, companies would be
able to continue to use existing recordkeeping systems so long as those
systems capture the information required by FDA. If FDA were to
eliminate the requirement for lot or production codes, we are confident
that GMA member companies will be able to comply with the recordkeeping
requirements without great difficulty.
Question 9) Some have raised concerns that the lack of FDA
inspectors at every port 24 hours a day, seven days a week will lead to
shipments being unnecessarily delayed at the border. Do you believe the
December 2003 Memorandum of Understanding between the FDA and Customs
that allows Customs officials to inspected shipments when the FDA is
not present will eliminate this potential problem or are more steps
required?
Response: If FDA is able to train adequately the Customs personnel
who will inspect when an FDA inspector is not available, we believe
that most problems will be eliminated. Absent considerable additional
resources for FDA to hire and train more inspectors, we believe that
the 2003 MOU is the only practical way to address the problem. It is
important that both FDA and Customs understand that prompt review of
products offered for importation is critical to the food industry and
to consumers who rely on the availability of a wide variety of food.
Question 10) Your organizations have both raised concern over the
ability of companies to bring in competitive samples and how this
impacts the ability of companies to perform research and development in
the United States. Given that these products are usually bought at the
retail level your companies would not have access to the manufacturer
registration number. Have you voiced these concerns with the FDA, and
if so what has been their reaction?
Response: GMA has provided FDA with a detailed description of its
concerns with the requirement for registration numbers for prior
notices that cover competitive samples. We have also discussed the
matter on several occasions with FDA representatives. As of yet, we
have received no indication that FDA is favorably disposed.
Question 11) Has either of your organizations provided the FDA
suggestions to address the problem of competitive sampling without
compromising the integrity of the registration and inspection system of
imported food products?
Response: GMA has provided FDA with a very specific suggestion to
address the competitive sample problem, without compromising the
integrity of the registration and inspection system for imported foods.
We have suggested to FDA that they permit a prior notice to indicate
that: (1) the product to be imported is a sample; (2) the registration
number is not available; and, (3) the product is destined for an R&D
facility. We have further suggested to FDA that it would be entirely
appropriate for FDA to increase the likelihood of inspection and
examination of products covered by a prior notice where the products
are characterized as ``samples.'' Moreover, FDA could well impose a
quantity limit on sample importations in order to further ensure that
the characterization of a shipment as containing samples is not abused.
More generally, we do not agree with FDA that requiring the
registration number is always an important element of prior notice or
that FDA can rely on the fact that a person who has a facility
registration number is a legitimate importer. Some facility
registration numbers will become known, either through carelessness or
something more nefarious. FDA should no more assume that possession of
a registration number indicates legitimacy than any law enforcement
officer should assume that knowing a social security number is proof of
one's identity.
Additional comments for the record:
GMA would like to take the occasion of responding to the
Committee's supplemental questions to take strong exception to the
testimony from representatives of the Association of Food and Drug
Officials (``AFDO'') concerning H.R. 2699, which would provide for
national uniformity in food labeling and safety regulation. AFDO
asserts, without any basis in fact, that the uniformity legislation
would undermine efforts to ensure the security of the food supply. Not
only were these comments outside the scope of the hearing, but also,
they were blatantly false. To the extent that the uniformity
legislation has any bearing on food security, it will help to enhance
food security. One of the challenges of homeland security is to apply
the available resources of government and the private sector in the
most efficient fashion possible. Requiring that the states enforce the
same requirements as those established by FDA--which is what the
uniformity legislation would do--is consistent with that principle. It
is wasteful and not consistent with food security to have inconsistent
requirements at the federal and state levels. Food safety and food
security require that all regulators enforce a consistent set of
requirements.
______
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