I
106TH CONGRESS
1ST SESSION
H. R. 830
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
safety of food from foreign countries.
IN THE HOUSE OF REPRESENTATIVES
FEBRUARY 24, 1999
Mr. DINGELL (for himself, Mr. BROWN of Ohio, Mr. STUPAK, Mr. PALLONE,
Mr. WAXMAN, Mr. MARKEY, Mr. BOUCHER, Mr. GORDON, Mr. DEUTSCH,
Mr. RUSH, Mr. KLINK, Mr. WYNN, Mr. GREEN of Texas, Ms. MCCARTHY
of Missouri, Ms. DEGETTE, Mr. BARRETT of Wisconsin, Mrs. CAPPS, Mr.
BONIOR, and Mr. SERRANO) introduced the following bill; which was re-
ferred 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 1999’’.
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.
SEC. 3. 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 1999, 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, 2000, 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. 4. 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 3(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 1999, 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, 2000, 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. 5. 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
2000, 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 1999 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
research under subsection (c)(7) of such
section. In expending the amount so re-
served, the Secretary shall give priority to
inspections conducted at ports of entry
into the United States.
‘‘(ii) The Secretary shall reserve not
more than 50 percent for carrying out re-
search under section 801(c)(7).
‘‘(3) AMOUNT
OF
FEE; COLLECTION.—A fee
under paragraph (1) shall be assessed on each line
item of food, as defined by the Secretary by regula-
tion. The amount of the fee shall be based on the
number of line items, and may not exceed $20 per
line item, notwithstanding subsection (b). The liabil-
ity for the fee constitutes a personal debt due to the
United States, and such liability accrues on the date
on which the Secretary approves the food under sec-
tion 801(c)(1). The Secretary may coordinate with
and seek the cooperation of other agencies of the
Federal Government regarding the collection of such
fees.
‘‘(b) TOTAL FEE REVENUES.—The total fee revenues
collected under subsection (a) for a fiscal year shall be
the amount appropriated under subsection (f)(3).
‘‘(c) ADJUSTMENTS.—
‘‘(1) INFLATION
ADJUSTMENT.—With respect
to the amount of total fee revenues referred to in
subsection (b), the amount authorized in subsection
(f)(3) for a fiscal year shall be adjusted by the Sec-
retary (and as adjusted shall be published in the
Federal Register) to reflect the greater of—
‘‘(A) the total percentage change that oc-
curred during the preceding fiscal year in the
Consumer Price Index for all urban consumers
(all items; U.S. city average); or
‘‘(B) the total percentage change for such
fiscal year in basic pay under the General
Schedule in accordance with section 5332 of
title 5, United States Code, as adjusted by any
locality-based comparability payment pursuant
to section 5304 of such title for Federal em-
ployees stationed in the District of Columbia.
‘‘(2) ANNUAL
FEE
ADJUSTMENT.—Not later
than 60 days after the end of each fiscal year begin-
ning after fiscal year 2000, the Secretary, subject to
not exceeding the maximum fee amount specified in
subsection (a)(3), shall adjust the amounts that oth-
erwise would under subsection (a) be assessed as
fees during the fiscal year in which the adjustment
occurs so that the total revenues collected in such
fees for such fiscal year equal the amount applicable
pursuant to subsection (b) for the fiscal year.
‘‘(d) FEE WAIVER OR REDUCTION.—The Secretary
shall grant a waiver from or a reduction of a fee assessed
under subsection (a) where the Secretary finds that the
fee to be paid will exceed the anticipated present and fu-
ture costs incurred by the Secretary in carrying out sec-
tion 801 with respect to food (which finding may be made
by the Secretary using standard costs).
‘‘(e) ASSESSMENT OF FEES.—
‘‘(1) LIMITATION.—Fees may not be assessed
under subsection (a) for a fiscal year beginning after
fiscal year 2000 unless the amount appropriated for
salaries and expenses of the Food and Drug Admin-
istration for such fiscal year is equal to or greater
than the amount appropriated for salaries and ex-
penses of the Food and Drug Administration for fis-
cal year 2000 multiplied by the adjustment factor
applicable to the fiscal year involved, except that in
making determinations under this paragraph for the
fiscal years involved there shall be excluded—
‘‘(A) the amounts appropriated under sub-
section (f)(3) for the fiscal years involved; and
‘‘(B) the amounts appropriated under sec-
tion 736(g) for such fiscal years.
‘‘(2) AUTHORITY.—If the Secretary does not
assess fees under subsection (a) during any portion
of a fiscal year because of paragraph (1) and if at
a later date in such fiscal year the Secretary may as-