I
105TH CONGRESS
2D SESSION
H. R. 4080
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
safety of food from foreign countries.
IN THE HOUSE OF REPRESENTATIVES
JUNE 18, 1998
Mr. DINGELL (for himself, Mr. BROWN of Ohio, Mr. STUPAK, Mr. PALLONE,
Mr. WAXMAN, Mr. MARKEY, Mr. BOUCHER, Mr. MANTON, Mr. GORDON,
Ms. FURSE, Mr. RUSH, Mr. KLINK, Mr. WYNN, Mr. GREEN, Ms. MCCAR-
THY of Missouri, and Ms. DEGETTE) introduced the following bill; which
was referred to the Committee on Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with
respect to the safety of food from foreign countries.
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 1998’’.
SEC. 2. ADDITIONAL AUTHORITIES OF FOOD AND DRUG AD-
MINISTRATION REGARDING 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 follow-
ing 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) 
commercially 
distributed 
within 
the
United States; or
‘‘(C) 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 the person or persons preparing,
packing, holding, manufacturing, or processing the
food involved cooperate with the Secretary in inspec-
tions regarding the food that are conducted by the
Secretary (including inspections conducted in foreign
countries).
‘‘(B) Whether the person or persons have a his-
tory of failing to comply with applicable provisions
of this Act regarding food.
‘‘(C) Whether the food (as a particular type of
product) has such a history.
‘‘(D) Whether there is such a history with re-
spect to a particular foreign country.
‘‘(E) 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.
‘‘(F) Whether the foreign country permits the
Secretary to conduct within the country inspections
regarding food.
‘‘(G) Such other factors as the Secretary deter-
mines to be appropriate.
‘‘(3)(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 sub-
stances as the Secretary determines to be appropriate.
‘‘(4) 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.
‘‘(5) The Secretary shall give high priority to increas-
ing significantly, relative to fiscal year 1998, the number
of inspections under this section, including the testing of
imported food for pesticide and microbial contamination,
that are conducted with respect to food at ports of entry
into the United States.
‘‘(6)(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, 1999, and subse-
quent reports shall be submitted annually thereafter.’’.
(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:
‘‘(aa)(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(aa) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331(aa)), 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. 3. RESEARCH ON TESTING TECHNIQUES FOR USE IN
INSPECTIONS OF FOOD SAFETY.
Section 801 of the Federal Food, Drug, and Cosmetic
Act, as amended by section 2(a), is amended in subsection
(c) by adding at the end the following paragraph:
‘‘(7)(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.
‘‘(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. The Secretary shall establish the
goal of developing, by the expiration of the three-year pe-
riod beginning on the date of the enactment of the Im-
ported Food Safety Act of 1998, tests under subparagraph
(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, 1999, 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
with the Secretary of Agriculture (acting through the
Food Safety Inspection Service of the Department of Agri-
culture) in carrying out the program.
‘‘(E) Of the amounts reserved under section
801A(a)(2)(B)(ii) for a fiscal year for carrying out the
program of research under subparagraph (A), the Sec-
retary shall make available not less than 50 percent for
making awards of grants or contracts to private entities
to conduct such research.’’.
SEC. 4. USER FEES REGARDING INSPECTIONS OF FOOD
SAFETY.
Chapter VIII of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 381 et seq.) is amended by inserting
after section 801 the following section:
‘‘USER FEES REGARDING FOOD SAFETY
‘‘SEC. 801A. (a) IN GENERAL.—
‘‘(1) ASSESSMENT.—Beginning in fiscal year
1999, the Secretary shall in accordance with this
section assess and collect fees on food imported into
the United States.
‘‘(2) PURPOSE OF FEES.—
‘‘(A) IN GENERAL.—The purpose of fees
under paragraph (1) is to defray increases in
the costs of the resources allocated for carrying
out section 801 with respect to food over the
costs of carrying out such section with respect
to food in fiscal year 1998 multiplied by the ad-
justment factor. Increases referred to in the
preceding sentence include increases in such
costs for an additional number of full-time
equivalent positions in the Department of
Health and Human Services to be engaged in
carrying out such section.
‘‘(B) ALLOCATIONS
BY
SECRETARY.—Of
the total fee revenues collected under paragraph
(1) for a fiscal year, the Secretary shall reserve
and expend amounts in accordance with the fol-
lowing:
‘‘(i) The Secretary shall reserve not
less than 50 percent for carrying out sec-
tion 801 with respect to food, other than