[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3075 Introduced in House (IH)]
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 Missouri, Mr.
Strickland, Mrs. Capps, and Mr. Doyle) 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 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 Representatives 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 safety 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, distribution, and sale, FDA may have access to
imported food for only a matter of hours at the international
border, and it cannot trace back beyond the border the origin
of imported food believed to be responsible 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 domestically produced food.
(4) FDA says its resources to deal with imported food
safety are limited. The General Accounting 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
ineffective 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 admissibility 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 Services has said
that protecting the Nation's food supply from imported food
that has been intentionally adulterated is a priority that
should be addressed.
SEC. 3. ADDITIONAL AUTHORITIES OF FOOD AND DRUG ADMINISTRATION
REGARDING IMPORTED FOOD SAFETY.
(a) Requirement for Prior Approval of Secretary 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 inserting
``(b)(1) Pending decision'', and by redesignating subsection
(c) as paragraph (2) of subsection (b); and
(2) by inserting after subsection (b) the following
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 believing
that the food involved may have been intentionally adulterated.
``(B) Whether the person or persons preparing, packing,
holding, manufacturing, or processing the food cooperate with
the Secretary in inspections regarding the food that are
conducted by the Secretary (including inspections conducted in
foreign countries).
``(C) Whether the person or persons have a history 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 respect 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 determines to be
appropriate.
``(3) If under paragraph (2)(A) the Secretary determines that there
is a reasonable basis for believing that a shipment of food may have
been intentionally adulterated, the following applies:
``(A) The Secretary shall take custody of the shipment.
``(B) The Secretary may not subsequently provide approval
under paragraph (1) for the shipment unless, on the basis of
tests of the shipment, the Secretary determines that the food
is not adulterated.
``(C) The Secretary shall require for purposes of
subparagraph (A) 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
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 destruction 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 permit the Secretary to conduct within the
country inspections 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 Secretary 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 pathogens or
substances as the Secretary determines to be appropriate.
``(C) If the Secretary of State determines that the government of a
foreign country has supported or otherwise 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 intentionally adulterated and is intended to be so imported or
offered, then the Secretary shall by order provide that, thereafter,
any 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 determined appropriate by the Secretary.
``(B) If the Secretary determines that food imported or offered for
import into the United States has been intentionally 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 determined appropriate by the Secretary.
``(6) The Secretary shall by regulation provide for the marking of
any shipment of food that has been denied approval 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 determines that such action is necessary for the Secretary to
carry out this subsection effectively.''.
(b) Criminal Penalties.--
(1) Acting without approval of secretary.--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 section 801
regarding the disposition of food that for purposes 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 labeling that identifies the country or countries in
which the food was grown, prepared, packed, manufactured, or processed,
except that this paragraph does not apply to food offered for retail
sale by restaurants or other eating establishments.''.
(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 INSPECTIONS OF IMPORTED
FOOD SAFETY; MAINTAINING PUBLIC CONFIDENCE; REPORTS 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 increasing
significantly, relative to fiscal year 2001, 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, with the greatest
priority given to inspections to detect the intentional adulteration of
food.
``(B) In carrying out subparagraph (A), the Secretary shall provide
for such numbers and types of food inspections 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 statistical confidence that the shipments have not
been intentionally 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 number of inspections and
tests that were conducted under this section with respect to food
during the preceding fiscal year, and the extent to which such number
is an increase 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 sampling food for
purposes of inspections under this section, including the testing of
imported food for pesticide and microbial contamination, and the levels
of confidence associated with the methodologies.
``(D) The first report under subparagraph (A) shall be submitted
not later than December 1, 2002, and subsequent reports shall be
submitted annually thereafter.''.
SEC. 5. RESEARCH ON TESTING TECHNIQUES FOR USE IN INSPECTIONS OF
IMPORTED FOOD SAFETY; PRIORITY REGARDING DETECTION OF
INTENTIONAL 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 development of tests and
sampling methodologies, for use in inspections 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 residues; 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 research 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 useful
in detecting the intentional adulteration of food.
``(C)(i) In providing for research under subparagraph (A), the
Secretary shall under subparagraph (B) give priority 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 determines to be
appropriate, including any pathogen or substance 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 subparagraph (A) for each
of the pathogens and substances receiving priority under the preceding
sentence.
``(ii) The Secretary shall submit to the Congress periodic 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 reports shall provide an estimate by the Secretary of the
amount of funds needed to meet such goal, and shall provide 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
semiannually 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 Prevention, the Director of the National Institutes
of Health, and the Administrator of the Environmental Protection
Agency. The Secretary shall with respect to such research coordinate
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
Agriculture) in carrying out the program.
``(E) Of the amounts reserved under section 801B(a)(2)(B)(ii) for a
fiscal year for carrying out the program of research under subparagraph
(A), the Secretary shall make available not less than 50 percent for
making awards of grants or contracts to private entities to conduct
such research.''.
SEC. 6. RECALL AUTHORITY REGARDING IMPORTED FOOD.
Chapter VIII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
381 et seq.) is amended by inserting after section 801 the following
section:
``recall authority regarding imported food
``Sec. 801A. (a) In General.--If the Secretary determines that
there is a reasonable basis for believing that food imported into the
United States has been intentionally adulterated, the following
applies:
``(1) The Secretary shall issue an order requiring the
appropriate persons (including importers, distributors, or
retailers) to immediately cease distribution of the food.
``(2) In the case of a food to which an order under
subparagraph (A) applies, the provisions of paragraphs (1) and
(2)(A) of section 518(e) regarding an informal hearing, and
amending an order of the Secretary to require a recall, apply
with respect to the food to the same extent and in the same
manner as such provisions apply with respect to devices.
``(b) Infant Formula.--With respect to the recall of infant
formula, section 412(e) applies in lieu of subsection (a) of this
section.''.
SEC. 7. USER FEES REGARDING INSPECTIONS OF IMPORTED FOOD SAFETY.
Chapter VIII of the Federal Food, Drug, and Cosmetic Act, as
amended by section 6 of this Act, is amended by inserting after section
801A the following section:
``user fees regarding food safety
``Sec. 801B. (a) In General.--
``(1) Assessment.--Beginning in fiscal year 2002, 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 2001
multiplied by the adjustment 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 following:
``(i) The Secretary shall reserve not less
than 50 percent for carrying out section 801
with respect to food, other than research under
subsection (c)(10) of such section. In
expending the amount so reserved, the Secretary
shall give priority to inspections conducted at
ports of entry into the United States, with the
greatest priority given to inspections to
detect the intentional adulteration of food.
``(ii) The Secretary shall reserve not more
than 50 percent for carrying out research under
section 801(c)(10).
``(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 regulation. 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 liability 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 section 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 Secretary (and as adjusted shall be published
in the Federal Register) to reflect the greater of--
``(A) the total percentage change that occurred
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 employees stationed in the District of
Columbia.
``(2) Annual fee adjustment.--Not later than 60 days after
the end of each fiscal year beginning after fiscal year 2002,
the Secretary, subject to not exceeding the maximum fee amount
specified in subsection (a)(3), shall adjust the amounts that
otherwise 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 future costs incurred by the Secretary in carrying out
section 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
2002 unless the amount appropriated for salaries and expenses
of the Food and Drug Administration for such fiscal year is
equal to or greater than the amount appropriated for salaries
and expenses of the Food and Drug Administration for fiscal
year 2002 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 subsection
(f)(3) for the fiscal years involved; and
``(B) the amounts appropriated under section 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 assess such fees, the Secretary may
assess and collect such fees, without any modification in the
rate of the fees, at any time in such fiscal year
notwithstanding the provisions of subsection (a)(3) relating to
the time at which fees are to be paid.
``(f) Crediting and Availability of Fees.--
``(1) In general.--Fees collected for a fiscal year
pursuant to subsection (a) shall be credited to the
appropriation account for salaries and expenses of the Food and
Drug Administration and shall be available in accordance with
appropriation Acts until expended without fiscal year
limitation. Such sums as may be necessary may be transferred
from the Food and Drug Administration salaries and expenses
appropriation account without fiscal year limitation to such
appropriation account for salaries and expenses with such
fiscal year limitation. The sums transferred shall be available
solely for carrying out section 801 with respect to food, and
the sums are subject to allocations under subsection (a)(2)(B).
``(2) Collections and appropriation acts.--The fees
authorized in subsection (a)--
``(A) shall be collected in each fiscal year in
accordance with subsections (a)(3) and (b); and
``(B) shall only be collected and available for the
purpose specified in subsection (a)(2).
``(3) Authorization of appropriations; allocations by
secretary.--Subject to paragraph (4) and subsection (c)(1),
there is authorized to be appropriated for fees under this
section $56,000,000 for each of the fiscal years 2002 through
2006.
``(4) Offset.--Any amount of fees collected for a fiscal
year under subsection (a) that exceeds the amount of fees
specified in appropriation Acts for such fiscal year shall be
credited to the appropriation account of the Food and Drug
Administration as provided in paragraph (1), and shall be
subtracted from the amount of fees that would otherwise be
authorized to be collected under this section pursuant to
appropriation Acts for a subsequent fiscal year.
``(g) Collection of Unpaid Fees.--In any case where the Secretary
does not receive payment of a fee assessed under subsection (a) within
30 days after it is due, such fee shall be treated as a claim of the
United States Government subject to subchapter II of chapter 37 of
title 31, United States Code.
``(h) Construction.--This section may not be construed as requiring
that the number of full-time equivalent positions in the Department of
Health and Human Services, for officers, employees, and advisory
committees not engaged in carrying out section 801 with respect to food
be reduced to offset the number of officers, employees, and advisory
committees so engaged.
``(i) Definition of Adjustment Factor.--For purposes of this
section, the term `adjustment factor' applicable to a fiscal year is
the lower of--
``(1) the Consumer Price Index for all urban consumers (all
items; United States city average) for April of the preceding
fiscal year divided by such Index for April 2001; or
``(2) the total of discretionary budget authority provided
for programs in categories other than the defense category for
the immediately preceding fiscal year (as reported in the
Office of Management and Budget sequestration preview report,
if available, required under section 254(c) of the Balanced
Budget and Emergency Deficit Control Act of 1985) divided by
such budget authority for fiscal year 2001 (as reported in the
Office of Management and Budget final sequestration report
submitted after the end of the 106th Congress, 2d Session).
The terms `budget authority' and `category' in subparagraph (B) are as
defined in the Balanced Budget and Emergency Deficit Control Act of
1985.''.
SEC. 8. ADDITIONAL FUNDING REGARDING DETECTION OF INTENTIONAL
ADULTERATION OF IMPORTED FOOD.
Chapter VIII of the Federal Food, Drug, and Cosmetic Act, as
amended by section 7 of this Act, is amended by inserting after section
801B the following:
``additional funding for detecting intentional adulteration of imported
food
``Sec. 801C. (a) Additional Authorization of Appropriations.--For
the purpose of carrying out the responsibilities of the Secretary under
sections 801 and 801A with respect to detecting the intentional
adulteration of food imported or offered for import into the United
States, including implementation of the plan developed by the Secretary
under subsection (b) of this section, there are authorized to be
appropriated such sums as may be necessary for each of the fiscal years
2002 through 2006. Such authorization is in addition to other
authorizations of appropriations that are available for such purpose.
``(b) Emergency Implementation Plan; Maintaining Public Confidence
Regarding Food Safety.--
``(1) In general.--Not later than 30 days after the date of
the enactment of the Imported Food Safety Act of 2001, the
Secretary shall submit to the Congress a plan for carrying out
the responsibilities of the Secretary that are described in
subsection (a).
``(2) Public confidence.--The plan under paragraph (1)
shall provide for such numbers and types of food inspections 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 plan shall provide for the testing of
samples of food in order to determine whether there is a high
level of statistical confidence that the food is not
intentionally adulterated.
``(3) Effective date.--With respect to the availability of
appropriations under subsection (a) to implement the plan
submitted to the Congress under paragraph (1), such plan takes
effect upon the expiration of the 30-day period beginning on
the date on which the plan is so submitted.''.
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