I
107TH CONGRESS
1ST SESSION
H. R. 3075
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
safety of food from foreign countries, including detecting the intentional
adulteration of food.
IN THE HOUSE OF REPRESENTATIVES
OCTOBER 10, 2001
Mr. DINGELL (for himself, Mr. BROWN of Ohio, Mr. WAXMAN, Mr. MARKEY,
Mr. BOUCHER, Mr. TOWNS, Mr. PALLONE, Mr. GORDON, Mr. DEUTSCH,
Mr. STUPAK, Mr. WYNN, Mr. GREEN of Texas, Ms. MCCARTHY of Mis-
souri, Mr. STRICKLAND, Mrs. CAPPS, and Mr. DOYLE) introduced the fol-
lowing bill; which was referred to the Committee on Energy and Com-
merce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with
respect to the safety of food from foreign countries,
including detecting the intentional adulteration of food.
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 ‘‘Imported Food Safety
Act of 2001’’.
SEC. 2. FINDINGS.
The Congress finds as follows:
(1) The Food and Drug Administration (FDA)
has confirmed that the number of produce-related
foodborne illness outbreaks in the United States has
increased in recent years.
(2) Imported food poses a special problem for
FDA in its efforts to guarantee the health and safe-
ty of the food American consumers eat. While FDA
has the ability to inspect and test food produced in
the United States at every stage of production, dis-
tribution, and sale, FDA may have access to im-
ported food for only a matter of hours at the inter-
national border, and it cannot trace back beyond the
border the origin of imported food believed to be re-
sponsible for outbreaks of foodborne illnesses.
(3) FDA data demonstrate that the pesticide
violation rate for imported food entering the United
States is nearly three time as great as for domesti-
cally produced food.
(4) FDA says its resources to deal with im-
ported food safety are limited. The General Account-
ing Office reported that between 1992 and 1997, the
number of imported food entries increased by more
than 200 percent, from 1.1 million to 2.7 million. At
the same time, FDA inspection of imported food has
fallen from an estimated 8 percent in fiscal year
1992 to 1.7 percent in fiscal year 1997.
(5) FDA confirms that there is a critical need
for rapid, accurate methods to detect, identify, and
quantify pathogens. For example, FDA can identify
only about half of the approximately 400 pesticides
for which the Environmental Protection Agency has
established tolerances. In addition, FDA says its
method for detecting hepatitis A on shellfish is inef-
fective for strawberries, and its method for detecting
cyclospora on raspberries is also ineffective.
(6) FDA lacks statutory authority to maintain
physical custody of imported foods until the admissi-
bility of the food has been determined, creating a
critical need for pathogen detection tests that will
produce real-time results while imported food is still
before FDA inspectors at the international border.
(7) The Secretary of Health and Human Serv-
ices has said that protecting the Nation’s food sup-
ply from imported food that has been intentionally
adulterated is a priority that should be addressed.
SEC. 3. ADDITIONAL AUTHORITIES OF FOOD AND DRUG AD-
MINISTRATION REGARDING IMPORTED FOOD
SAFETY.
(a) REQUIREMENT FOR PRIOR APPROVAL OF SEC-
RETARY FOR COMMERCIAL DISTRIBUTION AND RELATED
ACTIVITIES.—Section 801 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381) is amended—
(1) by striking ‘‘(b) Pending decision’’ and in-
serting ‘‘(b)(1) Pending decision’’, and by redesig-
nating subsection (c) as paragraph (2) of subsection
(b); and
(2) by inserting after subsection (b) the fol-
lowing subsection:
‘‘(c)(1) Food entering the United States shall not,
without the prior approval of the Secretary, be—
‘‘(A) transferred from the control of the person
who held control when the food entered the United
States;
‘‘(B) transported within the United States;
‘‘(C) commercially distributed within the United
States; or
‘‘(D) removed from its intact state, with respect
to the manner in which the food was packed for
transport.
‘‘(2) In determining whether to grant approval under
paragraph (1), the Secretary shall consider the following:
‘‘(A) Whether there is a reasonable basis for be-
lieving that the food involved may have been inten-
tionally adulterated.
‘‘(B) Whether the person or persons preparing,
packing, holding, manufacturing, or processing the
food cooperate with the Secretary in inspections re-
garding the food that are conducted by the Sec-
retary (including inspections conducted in foreign
countries).
‘‘(C) Whether the person or persons have a his-
tory of failing to comply with applicable provisions
of this Act regarding food.
‘‘(D) Whether the food (as a particular type of
product) has such a history.
‘‘(E) Whether there is such a history with re-
spect to a particular foreign country.
‘‘(F) Whether the system of regulating food
maintained in the foreign country provides at least
the same level of protection as domestic laws that
affect the safety of the food supply.
‘‘(G) Whether the foreign country permits the
Secretary to conduct within the country inspections
regarding food.
‘‘(H) Such other factors as the Secretary deter-
mines to be appropriate.
‘‘(3) If under paragraph (2)(A) the Secretary deter-
mines that there is a reasonable basis for believing that
a shipment of food may have been intentionally adulter-
ated, the following applies:
‘‘(A) The Secretary shall take custody of the
shipment.
‘‘(B) The Secretary may not subsequently pro-
vide approval under paragraph (1) for the shipment
unless, on the basis of tests of the shipment, the
Secretary determines that the food is not adulter-
ated.
‘‘(C) The Secretary shall require for purposes
of subparagraph (A) that proof be presented that
the shipment has been tested for the presence of mi-
crobial pathogens and pesticide chemicals or related
residues, and for such other pathogens or substances
as the Secretary determines to be appropriate.
‘‘(D) If the Secretary determines that the food
is adulterated, the Secretary shall cause the destruc-
tion of the food not later than 30 days thereafter.
‘‘(4)(A) If the system of regulating food maintained
in a foreign country does not provide at least the same
level of protection as domestic laws that affect the safety
of the food supply, or if the foreign country does not per-
mit the Secretary to conduct within the country inspec-
tions regarding food, the Secretary shall deny approval
under paragraph (1) for all food prepared, packed, held,
manufactured, or processed in the foreign country, except
as provided in subparagraph (B).
‘‘(B) In the case of a foreign country with respect
to which approval under paragraph (1) has been denied
under subparagraph (A), a shipment of food prepared,
packed, held, manufactured, or processed in the foreign
country may be granted approval under such paragraph
if the Secretary receives proof satisfactory to the Secretary
that food in the shipment is not adulterated. The Sec-
retary shall require for purposes of the preceding sentence
that proof be presented that the shipment has been tested
for the presence of microbial pathogens and pesticide
chemicals or related residues, and for such other patho-
gens or substances as the Secretary determines to be ap-
propriate.
‘‘(C) If the Secretary of State determines that the
government of a foreign country has supported or other-
wise aided or abetted one or more acts of international
terrorism, such country shall be considered to be a foreign
country to which subparagraph (A) applies. Subparagraph
(B) does not apply with respect such a foreign country.
‘‘(5)(A) If the Secretary determines that a person has
intentionally adulterated food that is imported or offered
for import into the United States, or has aided or abetted
the intentional adulteration of food that is so imported or
offered, or has prepared, packed, held, manufactured, or
processed the food knowing that the food has been inten-
tionally adulterated and is intended to be so imported or
offered, then the Secretary shall by order provide that,
thereafter, any food prepared, packed, held, manufac-
tured, or processed by such person may not be imported
into the United States. Such an order may be modified
or terminated, as determined appropriate by the Sec-
retary.
‘‘(B) If the Secretary determines that food imported
or offered for import into the United States has been in-
tentionally adulterated, but that a person who prepared,
packed, held, manufactured, or processed such food did
not know of the adulteration, the Secretary may by order
provide that, for a period not exceeding 180 days, food
prepared, packed, held, manufactured, or processed by
such person may not be imported into the United States.
Such an order may be modified or terminated, as deter-
mined appropriate by the Secretary.
‘‘(6) The Secretary shall by regulation provide for the
marking of any shipment of food that has been denied ap-
proval under paragraph (1) in a manner making it readily
apparent that the food has been refused admission into
the United States.
‘‘(7) The Secretary may limit the ports of entry into
the United States through which food, or particular foods
or food products, or food from particular points of origin
or with particular chains of distribution, is authorized to
be imported or offered for import if the Secretary deter-
mines that such action is necessary for the Secretary to
carry out this subsection effectively.’’.
(b) CRIMINAL PENALTIES.—
(1) ACTING
WITHOUT
APPROVAL
OF
SEC-
RETARY.—Section 301 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 331) is amended by
adding at the end the following:
‘‘(bb)(1) In the case of food, the carrying out of any
act in violation of section 801(c)(1).’’.
(2) FAILURE TO DISPOSE OF FOODS DENIED
ENTRY.—Section 301(bb) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331(bb)), as
added by paragraph (1), is amended by adding at
the end the following:
‘‘(2) The failure to comply with an order under sec-
tion 801 regarding the disposition of food that for pur-
poses of such section has been refused admission or denied
the approval of the Secretary.’’.
(3) FAILURE TO PROVIDE COUNTRY-OF-ORIGIN
LABELING FOR CERTAIN FOODS.—Section 403 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
343) is amended by adding at the end the following:
‘‘(t) If it is a food intended for human consumption,
it is grown, prepared, packed, manufactured, or processed
in a foreign country, and it fails, at the time the food is
offered for retail sale, to bear or be accompanied by label-
ing that identifies the country or countries in which the
food was grown, prepared, packed, manufactured, or proc-
essed, except that this paragraph does not apply to food
offered for retail sale by restaurants or other eating estab-
lishments.’’.
(c) CONFORMING AMENDMENT.—Section 801 of the
Federal Food, Drug, and Cosmetic Act, as amended by
subsection (a), is amended in subsection (b)(2) by striking
‘‘subsection (b)’’ and inserting ‘‘paragraph (1)’’.
SEC. 4. SIGNIFICANT INCREASES IN FREQUENCY OF IN-
SPECTIONS OF IMPORTED FOOD SAFETY;
MAINTAINING 
PUBLIC 
CONFIDENCE; 
RE-
PORTS TO CONGRESS.
Section 801 of the Federal Food, Drug, and Cosmetic
Act, as amended by section 3(a), is amended in subsection
(c) by adding at the end the following paragraphs:
‘‘(8)(A) The Secretary shall give high priority to in-
creasing significantly, relative to fiscal year 2001, the
number of inspections under this section, including the
testing of imported food for pesticide and microbial con-
tamination, that are conducted with respect to food at
ports of entry into the United States, with the greatest
priority given to inspections to detect the intentional adul-
teration of food.
‘‘(B) In carrying out subparagraph (A), the Secretary
shall provide for such numbers and types of food inspec-
tions at ports of entry into the United States as will, in
the determination of the Secretary, be sufficient for the
public to have confidence that food imported into the
United States has not been intentionally adulterated. For
purposes of the preceding sentence, the Secretary shall
provide for the testing of samples of food from shipments
in order to determine whether there is a high level of sta-
tistical confidence that the shipments have not been inten-
tionally adulterated.
‘‘(9)(A) The Secretary shall submit to the Congress
periodic reports describing the activities of the Secretary
under this section with respect to the safety of food.
‘‘(B) Each report under subparagraph (A) shall, for
each port of entry into the United States, specify the num-
ber of inspections and tests that were conducted under
this section with respect to food during the preceding fis-
cal year, and the extent to which such number is an in-
crease over the number of such inspections specified for
such port in the preceding report under subparagraph (A).
‘‘(C) Each report under subparagraph (A) shall state
the statistical methodologies used by the Secretary in sam-
pling food for purposes of inspections under this section,
including the testing of imported food for pesticide and
microbial contamination, and the levels of confidence asso-
ciated with the methodologies.
‘‘(D) The first report under subparagraph (A) shall
be submitted not later than December 1, 2002, and subse-
quent reports shall be submitted annually thereafter.’’.
SEC. 5. RESEARCH ON TESTING TECHNIQUES FOR USE IN
INSPECTIONS OF IMPORTED FOOD SAFETY;
PRIORITY REGARDING DETECTION OF INTEN-
TIONAL ADULTERATION.
Section 801 of the Federal Food, Drug, and Cosmetic
Act, as amended by section 4, is amended in subsection
(c) by adding at the end the following paragraph:
‘‘(10)(A) The Secretary shall (directly or through
grants or contracts) provide for research on the develop-
ment of tests and sampling methodologies, for use in in-
spections of food under this section—
‘‘(i) whose purpose is to determine whether food
is adulterated by reason of being contaminated with
microorganisms or pesticide chemicals or related res-
idues; and
‘‘(ii) whose results are available not later than
approximately 60 minutes after the administration
of the tests.
‘‘(B) In providing for research under subparagraph
(A), the Secretary shall give priority to conducting re-
search on the development of tests that are suitable for
inspections of food at ports of entry into the United
States, with the greatest priority given to the development
of such tests that the Secretary determines would be use-
ful in detecting the intentional adulteration of food.
‘‘(C)(i) In providing for research under subparagraph
(A), the Secretary shall under subparagraph (B) give pri-
ority to conducting research on the development of tests
for detecting the presence in food of the pathogens E. coli,
salmonella, cyclospora, cryptosporidium, hepatitis A, or
listeria, the presence in or on food of pesticide chemicals
and related residues, and the presence in or on food of
such other pathogens or substances as the Secretary deter-
mines to be appropriate, including any pathogen or sub-
stance that the Secretary determines is a candidate for
use to intentionally adulterate food. The Secretary shall
establish the goal of developing, by the expiration of the
three-year period beginning on the date of the enactment
of the Imported Food Safety Act of 2001, tests under sub-
paragraph (A) for each of the pathogens and substances
receiving priority under the preceding sentence.
‘‘(ii) The Secretary shall submit to the Congress peri-
odic reports describing the progress that has been made
toward the goal referred to in clause (i) and describing
plans for future research toward the goal. Each of the re-
ports shall provide an estimate by the Secretary of the
amount of funds needed to meet such goal, and shall pro-
vide a determination by the Secretary of whether there
is a need for further research under this paragraph. The
first such report shall be submitted not later than March
1, 2002, and subsequent reports shall be submitted semi-
annually after the submission of the first report until the
goal is met.
‘‘(D) The Secretary shall carry out the program of
research under subparagraph (A) in consultation with the
Director of the Centers for Disease Control and Preven-
tion, the Director of the National Institutes of Health, and
the Administrator of the Environmental Protection Agen-
cy. The Secretary shall with respect to such research co-
ordinate the activities of the Department of Health and
Human Services. The Secretary shall in addition consult