I
107TH CONGRESS
1ST SESSION
H. R. 3184
To amend the Federal Food, Drug, and Cosmetic Act to add provisions
regarding protecting the United States food supply.
IN THE HOUSE OF REPRESENTATIVES
OCTOBER 30, 2001
Ms. DELAURO introduced the following bill; which was referred to the
Committee on Energy and Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
add provisions regarding protecting the United States
food supply.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Protecting the Food
Supply from Bioterrorism Act’’.
SEC. 2. REGISTRATION OF PROCESSORS AND IMPORTERS.
(a) REGISTRATION.—
(1) IN GENERAL.—Any facility engaged in proc-
essing or handling food products for consumption in
the United States, including any facility of an im-
porter, shall be registered with the Secretary. To ob-
tain the registration—
(A) for a domestic facility not described in
subparagraph (B), the owner, operator, or
agent in charge of the facility shall submit an
application to the Secretary; and
(B) for a facility of an importer, or for a
foreign facility, the importer seeking to import
the food product processed or handled in the fa-
cility shall submit the application.
(2) APPLICATION.—
(A) IN
GENERAL.—The applicant shall
submit the application to the Secretary in such
manner and containing such information as the
Secretary shall prescribe.
(B) SUBMISSION.—The applicant shall
submit the application as provided for by the
Secretary.
(C) CONTENTS.—In the case of an applica-
tion submitted for a foreign facility, the appli-
cation shall contain, at a minimum, such infor-
mation as the Secretary may require dem-
onstrating that the facility, and the foreign na-
tion involved, will permit inspections described
in this title.
(3) PROCEDURE.—Upon receipt and review of a
completed application described in paragraph (1),
the Secretary shall issue to the applicant a certifi-
cate of registration unless the Secretary finds that
there is good cause for denial of the application. The
Secretary shall promptly notify the applicant of the
denial, include in the notification a written expla-
nation of the reasons for such denial, and provide an
opportunity for a hearing or reapplication upon re-
quest.
(4) LIST.—The Secretary shall compile and
maintain an up-to-date list of facilities that are reg-
istered under this section.
(b) SUSPENSION OF REGISTRATION.—
(1) BASIS.—The registration of a facility, in-
cluding the facility of an importer, may be sus-
pended immediately by the Secretary for—
(A) failure to permit access to the facility
for inspection under this Act;
(B) violation of a food safety law, includ-
ing a regulation issued under a food safety law,
concerning the facility, in a case in which the
Secretary determines that such suspension is
likely to prevent a significant risk of adverse
health consequences; or
(C) conviction of the applicant or reg-
istrant in any Federal or State court of—
(i) any felony relating to food, wheth-
er or not the felony is based upon the ac-
quisition, handling, or distribution of adul-
terated or misbranded food; or
(ii) more than 1 violation of any law
relating to food, whether or not the viola-
tion involves any fraud in connection with
transactions in food.
(2) IMPACT.—No person may introduce a food
product into interstate commerce, or offer a food
product for import into the United States, from a
facility with a suspended registration.
(3) REINSTATEMENT.—Any registration sus-
pended under paragraph (1) may be reinstated
whenever the Secretary determines that the suspen-
sion is no longer necessary.
(c) EXEMPTION AUTHORITY.—The Secretary may by
regulation exempt classes of facilities from the require-
ments of subsection (a) if the Secretary determines that
the registration of such facilities is not needed for effective
enforcement of a food safety law.
(d) DEFINITIONS.—In this section:
(1) FACILITY.—The term ‘‘facility’’ includes
any factory, warehouse, or establishment (including
a factory, warehouse, or establishment of an im-
porter), that handles or processes food.
(2) SECRETARY.—The term ‘‘Secretary’’ means
the Secretary of Health and Human Services.
SEC. 3. ENFORCEMENT AUTHORITIES.
(a) DETENTION.—Chapter III of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331 et seq.) is amend-
ed by inserting after section 304 the following:
‘‘SEC. 304A. ADMINISTRATIVE DETENTION.
‘‘Any food that the Secretary reasonably believes may
be adulterated or misbranded when introduced into or
while in interstate commerce, or while held for sale
(whether or not the first sale) after shipment in interstate
commerce, may be detained and held by the Secretary for
not more than 20 days, pending action regarding such
food under sections 302 or 304. During such 20-day pe-
riod, such food shall not be moved by any person (other
than the Secretary) from the place at which such food was
seized until the Secretary authorizes a release.’’.
(b) RECORDS.—Chapter IV of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amend-
ed by inserting after section 404 the following:
‘‘SEC. 404A. RECORDS.
‘‘(a) IN GENERAL.—The Secretary shall promulgate
regulations requiring each factory, warehouse, or estab-
lishment in which food is manufactured, processed,
packed, or held for introduction into interstate commerce
to retain records to effect and monitor any recall author-
ized under this Act and to retain any other records reason-
ably bearing on food that is manufactured or held in the
facility that may be in violation of a Federal or State food
safety law. Such regulations shall require that the Sec-
retary have access to and be allowed to copy such records
at all times. It shall be unlawful for any person to fail
to retain such records or to fail to permit the Secretary
to inspect or copy such records.
‘‘(b) CONTENT.—The records retained under sub-
section (a) shall be maintained for a reasonable period of
time as determined by the Secretary. The records shall
include information concerning—
‘‘(1)(A) the origin, receipt, delivery, sale, move-
ment, holding, and disposition of food products, or
ingredients for food products, processed or handled
at the facility;
‘‘(B) the identity and amount of ingredients
used in the food involved;
‘‘(C) the processing or handling of food;
‘‘(D) the results of laboratory, sanitation, or
other quality control tests performed on the food or
in the facility; and
‘‘(E) consumer complaints concerning food or
the packaging of the food; and
‘‘(2) other matters reasonably related to wheth-
er food products processed or handled at the facility
may be in violation of a food safety law under this
Act.
‘‘(c) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to alter or amend in any way sec-
tion 301(j) of this Act or section 552 of title 5 or section
1995 of title 18, United States Code.’’.
(c) PENALTIES.—Section 303(g)(2)(A) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C.
333(g)(2)(A)) is amended by striking ‘‘402(a)(2)(B)’’ and
inserting ‘‘402’’.
(d) CROSS-UTILIZATION
OF INSPECTORS.—Section
702 of the Federal Food, Drug, and Cosmetic Act is
amended by inserting after the first sentence: ‘‘In the case
of food, the Secretary is additionally authorized to conduct
examinations and investigations for the purposes of this
Act through the officers and employees of the Department
of Agriculture, duly commissioned by the Secretary as an
officer of the Department of Health and Human Serv-
ices.’’.
(e) CLARIFICATION OF AUTHORITIES BASED ON EPI-
DEMIOLOGICAL EVIDENCE.—Section 402 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 342) is
amended—
(1) in subsection (a)—
(A) by striking ‘‘; or (7)’’ and inserting ‘‘;
(7)’’; and
(B) by striking ‘‘to section 409.’’ and in-
serting ‘‘to section 409; or (8) if the Secretary
declares such food to pose an immediate risk of
significant harm to public health or safety
based on epidemiological evidence, except that
the authority to make such declaration shall not
be delegated and the Secretary shall promptly
after such a declaration initiate a proceeding in
accordance with sections 554 and 556 of title 5,
United States Code, to affirm or withdraw the
declaration.’’.
SEC. 4. NOTIFICATION AND RECALL.
Chapter IV of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 341 et seq.) is amended by adding after
section 409 the following:
‘‘SEC. 409A. NOTIFICATION AND RECALL OF UNSAFE FOOD.
‘‘(a) NOTICE TO SECRETARY OF VIOLATION.—Any
person (other than a household consumer or other indi-
vidual who is the intended consumer of an article of food)
that has a reasonable basis for believing that any article
of food introduced into or in interstate commerce, or held
for sale (whether or not the first sale) after shipment in
interstate commerce, may be in violation of a food safety
law shall immediately notify the Secretary, in such manner
and by such means as the Secretary may by regulation
prescribe, of the identity and location of such article.
‘‘(b) RECALL AND CONSUMER NOTIFICATION.—
‘‘(1) VOLUNTARY
PROCEDURES.—If the Sec-
retary finds, on notification under subsection (a) or
otherwise, that any article of food is in violation of
a food safety law when introduced into or while in
interstate commerce or while held for sale (whether
or not the first sale) after shipment in interstate
commerce and there is a reasonable probability that
such article, if consumed, would present a threat to
public health, as determined by the Secretary, the
Secretary shall provide the appropriate persons (in-
cluding the manufacturers, importers, distributors,
or retailers of the article) with an opportunity to—
‘‘(A) cease distribution of such article;
‘‘(B) notify all persons—
‘‘(i) producing, manufacturing, pack-
ing, processing, preparing, treating, pack-
aging, distributing, or holding such article
to immediately cease such activities with
respect to such article; or
‘‘(ii) to which such article has been
distributed, transported, or sold, to imme-
diately cease distribution of such article;
‘‘(C) recall such article;
‘‘(D) provide, in consultation with the Sec-
retary, notice of the finding of the Secretary to
consumers to whom such article was, or may
have been, distributed; or
‘‘(E) take any combination of the above
measures, as determined by the Secretary to be
appropriate in the circumstances.
‘‘(2) PREHEARING ORDER TO CEASE DISTRIBU-
TION AND GIVE NOTICE.—If such appropriate person
refuses to or does not voluntarily cease distribution,
make notification, recall such article, or provide no-
tice to consumers, as applicable, within the time and
in the manner prescribed by the Secretary, the Sec-
retary shall, by order, require, as the Secretary de-
termines to be necessary, such person to—
‘‘(A) immediately cease distribution of
such article;
‘‘(B) immediately notify all persons—
‘‘(i) producing, manufacturing, pack-
ing, processing, preparing, treating, pack-
aging, distributing, or holding such article
to immediately cease such activities with
respect to such article; or
‘‘(ii) to which such article has been
distributed, transported, or sold, to imme-
diately cease distribution of such article; or
‘‘(C) immediately take the actions specified
in both subparagraphs (A) and (B).
‘‘(3) NOTIFICATION
OF
CONSUMERS
BY
SEC-
RETARY.—The Secretary shall, as the Secretary de-
termines to be necessary, provide notice of the find-
ing of the Secretary under paragraph (1) to con-
sumers to whom such article was, or may have been,
distributed.
‘‘(c) HEARING ON ORDER.—The Secretary shall pro-
vide any person subject to an order under subsection (b)
with an opportunity for a hearing, to be held as soon as
practicable but not later than 2 days after the issuance
of the order, on the actions required by the order and on
whether the article that is the subject of the order should
be recalled.
‘‘(d) POST-HEARING RECALL ORDER.—
‘‘(1) AMENDMENT OF ORDER.—If, after pro-
viding an opportunity for a hearing under subsection
(c), the Secretary determines that there is a reason-
able probability that the article that is the subject
of an order under subsection (b), if consumed, pre-
sents a threat to public health, the Secretary, as the
Secretary determines to be necessary, may—
‘‘(A) amend the order to require recall of
such article or other appropriate action;
‘‘(B) specify a timetable in which the recall
shall occur;
‘‘(C) require periodic reports to the Sec-
retary describing the progress of the recall; and
‘‘(D) provide notice of the recall to con-
sumers to whom such article was, or may have
been, distributed.
‘‘(2) VACATION OF ORDER.—If, after such a
hearing, the Secretary determines that adequate
grounds do not exist to continue the actions required
by the order, the Secretary shall vacate the order.
‘‘(e) REMEDIES NOT EXCLUSIVE.—The remedies
provided in this section shall be in addition to and not
exclusive of other remedies that may be available.’’.
SEC. 5. DEFINITIONS AND STANDARDS FOR FOOD.
Section 401 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 341 et seq.) is amended—
(1) by striking ‘‘Whenever in the judgment’’
and inserting ‘‘(a) Whenever in the judgment’’; and
(2) by adding at the end the following:
‘‘(b) The Secretary shall issue regulations that estab-
lish standards for process controls and tolerances for con-
taminants in food products as appropriate to assure that
food from both domestic and imported facilities are in
compliance with the requirements of food safety laws
under this Act.’’.
SEC. 6. STRENGTHENING IMPORT INSPECTIONS.
(a) ASSURING EQUIVALENT STANDARDS
FOR IM-
PORTS.—Section 402 of the Federal Food, Drug, and Cos-
metic Act is amended by adding at the end the following:
‘‘(h) If it is food that is offered for import into the
United States and has not been manufactured, processed,
packed or held under a system or conditions, or subject
to measures that meet the requirements of this Act, or
that otherwise achieve the level of protection required, as
determined by the Secretary, for such food manufactured,
processed, packed or held in the United States. In deter-
mining whether a system, conditions, or measures meet
the requirements of this Act or otherwise achieve the level
of protection required, the Secretary may consider whether
an officer or employee, duly designated by the Secretary
has requested, and has been refused, access to the estab-
lishment or location where such food was manufactured,
processed, packed or held for the purpose of inspection
(including sample collection), testing, or other relevant
procedures, at a reasonable time and in a reasonable man-
ner, and may deny the importation of such food from such
establishment or location on the basis of such refusal and
other relevant factors.’’.
(b) 
ADVANCE
NOTICE
REGARDING
IMPORTED
FOOD.—Chapter VIII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381 et seq.) is amended by add-
ing at the end the following:
‘‘SEC. 805. NOTICE REGARDING IMPORTED FOOD.
‘‘The Secretary of Health and Human Services, in
consultation with the Secretary of the Treasury, may re-
quire a manufacturer or importer of food imported or of-
fered for import into the United States to provide the Sec-
retary of Health and Human Services with advance notice
of such importation before such importation.’’.
SEC. 7. RESEARCH AND TRAINING AMENDMENTS TO THE
PUBLIC HEALTH SERVICE ACT.
Subpart 6 of title IV of the Public Health Service
Act (42 U.S.C. 285f et seq.) is amended by adding at the
end the following:
‘‘SEC. 
447C. 
FOOD 
SECURITY 
RESEARCH 
INITIATIVE
THROUGH DIRECTOR OF NATIONAL INSTI-
TUTES OF HEALTH.
‘‘(a) EXPANSION, INTENSIFICATION, AND COORDINA-
TION OF ACTIVITIES.—
‘‘(1) IN GENERAL.—The Director of NIH, in
consultation with the Joint Institute for Food Safety
Research, and other agencies as appropriate, shall
coordinate, expand, and intensify their programs
concerning food-borne illness, including food-borne
illnesses potentially associated with terrorism.
‘‘(b) CENTERS OF EXCELLENCE.—
‘‘(1) IN GENERAL.—The Director of NIH shall
award grants and contracts to public or nonprofit
private entities to pay all or part of the costs of
planning, establishing, improving, and providing
basic operating support for centers of excellence for
research into and training in food-borne illness, in-
cluding food-borne illnesses potentially associated
with terrorism.
‘‘(2) POLICIES.—A grant or contract awarded
under paragraph (1) shall be entered into an accord-
ance with policies established by the Director of
NIH.
‘‘(3) USE OF FUNDS.—Funds awarded under
this subsection may be used for—
‘‘(A) the development of diagnostic tech-
niques that are capable of rapidly detecting and
identifying agents of food-borne illness, includ-
ing food-borne illnesses that are potentially as-
sociated with terrorism; and
‘‘(B) clinical training, including training
for allied health professionals, continuing edu-
cation for health professionals and allied health
professions personnel, and information pro-
grams for the public with respect to food-borne
illness, including food-borne illness potentially
associated with terrorism.
‘‘(c) COORDINATION WITH OTHER INSTITUTES.—
The Director of NIH shall coordinate the activities under
this section with similar activities conducted by other na-
tional research institutes, centers, and agencies of the Na-
tional Institutes of Health, the Food and Drug Adminis-
tration, and other agencies to the extent that such insti-
tutes, centers, and agencies have responsibilities that are
related to food-borne illness, including food-borne illness
potentially associated with terrorism.
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There
is authorized to be appropriated to carry out this section,
$50,000,000 for fiscal year 2002, and such sums as may
be necessary for subsequent fiscal years.’’.
SEC. 8. SURVEILLANCE AND INFORMATION GRANTS AND
AUTHORITIES.
Title III of the Public Health Service Act (42 U.S.C.
241 et seq.) is amended by inserting after section 317P
the following:
‘‘SEC. 317Q. FOOD SAFETY GRANTS.
‘‘(a) IN GENERAL.—The Secretary may award food
safety grants to States to expand the number of States
participating in Pulsenet, the Foodborne Diseases Active
Surveillance Network, and other networks to enhance Fed-
eral, State, and local food safety efforts.
‘‘(b) USE OF FUNDS.—Funds awarded under this
section shall be used by States to assist such States in
meeting the costs of establishing and maintaining the food
safety surveillance, technical and laboratory capacity need-
ed to participate in Pulsenet, Foodborne Diseases Active
Surveillance Network, and other networks to enhance Fed-
eral, State, and local food safety efforts.
‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There
is authorized to be appropriated to carry out this section,
$40,000,000 for fiscal year 2002, and such sums as may
be necessary for subsequent fiscal years.
‘‘SEC. 317R. SURVEILLANCE OF ANIMAL AND HUMAN
HEALTH.
‘‘(a) IN GENERAL.—The Secretary, through the
Commissioner of the Food and Drug Administration, the
Director of the Centers for Disease Control and Preven-
tion, and the Secretary of Agriculture, shall develop and
implement a plan for coordinating the surveillance for
zoonotic disease and human disease.
‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—There
is authorized to be appropriated to carry out this section,
such sums as may be necessary.
‘‘SEC. 317S. INFORMATION RESOURCES FOR HEALTH PRO-
FESSIONALS.
‘‘(a) IN GENERAL.—The Secretary, through the Di-
rector of the Centers for Disease Control may establish,
or, may enter into contracts to establish hotlines, informa-
tion technology systems, or other information resources to
assist and educate health professionals in the diagnosis
and detection of illnesses caused by bioterrorism, including
food-borne bioterrorism.
‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—There
is authorized to be appropriated to carry out this section,
$10,000,000 for fiscal year 2002, and such sums as may
be necessary for subsequent fiscal years.’’.
SEC. 9. DEFINITIONS.
Chapter II of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321 et seq.) is amended by adding at the
end the following:
‘‘(kk) The term ‘contaminant’ includes a bacterium,
a chemical contaminant, a natural toxin, a virus, a para-
site, and a physical hazard, that when found on or in food
can cause human illness or injury.
‘‘(ll) The term ‘process’ means the commercial har-
vesting, preparation, manufacture, or transportation of a
food product.’’.
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