[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3610 Introduced in House (IH)]
110th CONGRESS
1st Session
H. R. 3610
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
safety of food and drugs imported into the United States, and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 20, 2007
Mr. Dingell (for himself, Mr. Pallone, and Mr. Stupak) 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 and drugs imported into the United States, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Food and Drug
Import Safety Act of 2007''.
(b) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Research on testing techniques for use in inspections of
imported food safety; priority regarding
detection of intentional adulteration.
Sec. 3. User fees regarding inspections of imported food safety.
Sec. 4. User fees regarding inspections of imported drug safety.
Sec. 5. Authority to restrict food importation to specific ports of
entry.
Sec. 6. Country of origin labeling.
Sec. 7. Safe and secure food importation program.
Sec. 8. Civil penalties.
Sec. 9. Continued operation of field laboratories.
Sec. 10. Recall authority.
Sec. 11. Inspection and other standards; applicability, enforcement;
certifications.
Sec. 12. Regulations on adequate testing of processed food.
Sec. 13. Records of interstate shipment.
Sec. 14. Labeling requirement for meat, poultry products, and seafood
that contain carbon monoxide.
SEC. 2. 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 (21 U.S.C.
381) is amended by adding at the end the following:
``(p) Research on Testing Techniques for Use in Inspections of
Imported Food Safety.--
``(1) In general.--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--
``(A) whose purpose is to determine whether food is
adulterated by reason of being contaminated with
microorganisms, chemical toxins, or pesticide chemicals
or related residues; and
``(B) whose results are available not later than
approximately 60 minutes after the administration of
the tests.
``(2) Priority.--In providing for research under paragraph
(1), 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. In providing for research
under paragraph (1), the Secretary shall under the preceding
sentence 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, the presence in or on
food of chemical toxins, 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 3-year period beginning on
the date of the enactment of the this subsection, tests under
paragraph (1) for each of the pathogens and substances
receiving priority under the preceding sentence.
``(3) Periodic reports.--The Secretary shall submit to the
Congress periodic reports describing the progress that has been
made toward the goal referred to in paragraph (1) 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 subsection. The first such report
shall be submitted not later than March 1, 2008, and subsequent
reports shall be submitted semiannually after the submission of
the first report until the goal is met.
``(4) Consultation.--The Secretary shall carry out the
program of research under paragraph (1) 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 and Inspection
Service of the Department of Agriculture) in carrying out the
program.''.
SEC. 3. USER FEES REGARDING INSPECTIONS OF IMPORTED FOOD SAFETY.
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:
``user fees regarding food safety
``Sec. 801A. (a) In General.--
``(1) Assessment.--Beginning in fiscal year 2008, 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 the costs of carrying out
section 801 with respect to food over the costs of
carrying out such section with respect to food in
fiscal year 2007 multiplied by the adjustment factor.
Fees under paragraph (1) may be used to pay for
overseas inspection with respect to food by the
Department of Health and Human Services.
``(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 90 percent for carrying out section 801
with respect to food, other than research under
section 801(p). 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 10 percent for carrying out research under
section 801(p).
``(C) Laboratory testing.--In this paragraph, the
term `costs of carrying out section 801' with respect
to food being imported or offered for import includes
the costs of laboratory testing of such food, including
laboratory personnel costs.
``(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 $50 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 2008,
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
2008 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 2008 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;
``(B) the amounts appropriated under section
801B(f)(3) for such fiscal years; and
``(C) 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 $500,000,000 for each of the fiscal years 2008 through
2012.
``(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 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 2007.''.
SEC. 4. USER FEES REGARDING INSPECTIONS OF IMPORTED DRUG SAFETY.
Chapter VIII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
381 et seq.), as amended by section 3, is further amended by inserting
after section 801A the following:
``user fees regarding drug safety
``Sec. 801B. (a) In General.--
``(1) Assessment.--Beginning in fiscal year 2008, the
Secretary shall in accordance with this section assess and
collect fees on drugs imported into the United States.
``(2) Purpose of fees.--
``(A) In general.--The purpose of fees under
paragraph (1) is to defray the costs of carrying out
section 801 with respect to drugs over the costs of
carrying out such section with respect to drugs in
fiscal year 2007 multiplied by the adjustment factor.
Fees under paragraph (1) may be used to pay for
overseas inspection with respect to drugs by the
Department of Health and Human Services.
``(B) Priority.--In expending the fee revenue
amounts collected under paragraph (1), the Secretary
shall give priority to--
``(i) inspections conducted at ports of
entry into the United States, with the greatest
priority given to inspections to detect the
intentional adulteration or misbranding of
drugs; and
``(ii) inspections of good manufacturing
practices conducted abroad.
``(C) Laboratory testing.--In this paragraph, the
term `costs of carrying out section 801' with respect
to drugs being imported or offered for import includes
the costs of laboratory testing of such drugs,
including laboratory personnel costs.
``(3) Amount of fee; collection.--A fee under paragraph (1)
shall be assessed on each line item of drugs, 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 $1000 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 drugs 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 2008,
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 drugs (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
2008 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 2008 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;
``(B) the amounts appropriated under section
801A(f)(3) for such fiscal years; and
``(C) 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 drugs.
``(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 $300,000,000 for each of the fiscal years 2008 through
2012.
``(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
drugs 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 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 2007.''.
SEC. 5. AUTHORITY TO RESTRICT FOOD IMPORTATION TO SPECIFIC PORTS OF
ENTRY.
Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
381), as amended by section 2, is further amended by adding at the end
the following:
``(q) Authority To Restrict Food Importation to Specific Ports of
Entry.--
``(1) In general.--The Secretary shall restrict the
importation of all food to ports of entry that are located in a
metropolitan area with a laboratory of the Food and Drug
Administration for testing such food.
``(2) Waiver.--The Secretary may waive the requirement of
paragraph (1) and authorize the importation of food to a port
of entry not described in such paragraph if the Secretary
certifies that--
``(A) the importation of such food through such
port will not increase the probability that such food
will cause serious, adverse health consequences or
death; or
``(B) there is a reasonable probability that the
type food involved will not cause serious, adverse
health consequences or death.
``(3) Implementation.--The Secretary shall implement this
subsection beginning not later than 5 years after the date of
the enactment of this subsection.''.
SEC. 6. COUNTRY OF ORIGIN LABELING.
(a) Food.--Section 403 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 343) is amended by adding at the end the following:
``(z) If the labeling of the food fails to identify the country of
origin of the food.''.
(b) Drugs and Devices.--Section 502 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the
following:
``(y) If it is a drug or device and its labeling fails to identify
the country of origin of the drug or device.''.
(c) Regulations.--Not later than 180 days after the date of the
enactment of this Act, the Secretary shall promulgate final regulations
to carry out sections 403(z) and 502(y) of the Federal Food, Drug, and
Cosmetic Act, as added by subsections (a) and (b), respectively.
(d) Effective Date.--The requirements of sections 403(z) and 502(y)
of the Federal Food, Drug, and Cosmetic Act, as added by subsections
(a) and (b), respectively, take effect on the date that is 180 days
after the date of the enactment of this Act.
SEC. 7. SAFE AND SECURE FOOD IMPORTATION PROGRAM.
Chapter VIII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
381 et seq.) is amended by adding at the end the following:
``SEC. 805. SAFE AND SECURE FOOD IMPORTATION PROGRAM.
``(a) In General.--Beginning not later than 2 years after the date
of the enactment of this section, the Secretary shall establish by
regulation and carry out a program under which--
``(1) persons importing food into the United States
voluntarily agree to abide by the food safety and security
guidelines developed under subsection (b); and
``(2) the Secretary agrees to expedite the movement of such
food through the inspection process.
``(b) Guidelines.--
``(1) Development.--For purposes of the program established
under subsection (a), the Secretary shall develop safety and
security guidelines applicable to the importation of food.
``(2) Factors.--The guidelines developed under paragraph
(1) shall take into account the following factors:
``(A) The personnel of the person importing the
food.
``(B) The physical and procedural safety and
security of such person's food supply chain.
``(C) The sufficiency of access controls for food
and ingredients purchased by such person.
``(D) The need for tracking and maintaining records
on food and ingredients purchased by such person or
moved through the supply chain.
``(E) Documentation processing through such
person's supply chain.
``(F) Access by the Secretary to such person's
business records for review.
``(G) Vendor and supplier information.
``(H) Such other factors as the Secretary
determines necessary.''.
SEC. 8. CIVIL PENALTIES.
Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
333) is amended--
(1) by redesignating subsection (g) (relating to civil
penalties) as subsection (f): and
(2) in subparagraph (A) of paragraph (2) of subsection (f),
as so redesignated, by striking ``Any person who introduces''
and all that follows through the end of the subparagraph and
inserting the following: ``Any person who introduces into
interstate commerce or delivers for introduction into
interstate commerce an article of food that is adulterated
within the meaning of section 402(a)(2)(B) shall be subject to
a civil money penalty of--
``(i) not more than $50,000 in the case of any
individual and $250,000 in the case of any other person
for such introduction or delivery, not to exceed
$500,000 for all such violations adjudicated in a
single proceeding; or
``(ii) notwithstanding clause (i), if such person
is the manufacturer or the importer of the food, not
more than $100,000 in the case of any individual and
$500,000 in the case of any other person for such
introduction or delivery, not to exceed $1,000,000 for
all such violations adjudicated in a single
proceeding.''.
SEC. 9. CONTINUED OPERATION OF FIELD LABORATORIES.
(a) In General.--Subject to subsections (b) and (d), the Secretary
of Health and Human Services (in this section referred to as the
``Secretary'') shall not--
(1) terminate any of the 13 field laboratories that were
operated by the Office of Regulatory Affairs of the Food and
Drug Administration as of January 1, 2007;
(2) consolidate any such laboratory with any other
laboratory;
(3) terminate any of the 20 district offices or any of the
inspection or compliance functions of any of the 20 district
offices of the Food and Drug Administration functioning as of
January 1, 2007; or
(4) consolidate--
(A) any such district office with an office in any
other district; or
(B) transfer any of the compliance or inspection
functions of any such district office to any other
district.
(b) Report by Secretary.--
(1) Submission.--The Secretary shall submit a
reorganization plan involving the termination or consolidation
of the laboratories, the district offices, or the functions of
such district offices specified in subsection (a) to the
Comptroller General, the Committee on Energy and Commerce of
the House of Representatives, and the Committee on Health,
Education, Labor, and Pensions of the Senate.
(2) Consultation.--In preparing the reorganization plan
described in paragraph (1), the Secretary shall consult with
personnel and unions to be affected by the plan.
(c) Report by GAO.--The Comptroller General shall study the cost
effectiveness of the reorganization plan described in subsection (b)
and its impact on the safety of food, drug, and other products
regulated under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301
et seq.) and the Public Health Service Act (42 U.S.C. 201 et seq.) and
report to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor, and
Pensions of the Senate.
(d) Reorganization.--
(1) Congressional review.--The reorganization plan
described in subsection (b) is deemed to be a major rule (as
defined in section 804(2) of title 5, United States Code) for
purposes of chapter 8 of such title.
(2) Effective date.--Notwithstanding section 801(a)(3) of
title 5, United States Code, the reorganization plan described
in subsection (b) shall take effect (unless disapproved under
section 802 of such title) on the date that is 180 days after
the date on which the Comptroller General submits the report
required by subsection (c).
SEC. 10. RECALL AUTHORITY.
Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
351 et seq.), as amended by section 6 of this Act, is amended by adding
at the end the following:
``SEC. 418. RECALL AUTHORITY.
``(a) Order To Cease Distribution.--
``(1) In general.--If the Secretary finds that a food may
cause serious, adverse health consequences or death, the
Secretary shall issue an order requiring the appropriate person
(including the manufacturers, importers, distributors, or
retailers of the food) to immediately cease distribution of the
food.
``(2) Informal hearing.--An order under paragraph (1) shall
provide the person subject to the order with an opportunity for
an informal hearing, to be held not later than 10 days after
the date of the issuance of the order, on the actions required
by the order and on whether the order should be amended to
require a recall of the food involved. If, after providing an
opportunity for such a hearing, the Secretary determines that
inadequate grounds exist to support the actions required by the
order, the Secretary shall vacate the order.
``(b) Order To Recall.--
``(1) In general.--If, after providing an opportunity for
an informal hearing under subsection (a)(2), the Secretary
determines that the order should be amended to include a recall
of the food with respect to which the order was issued, the
Secretary shall, except as provided in paragraphs (2) and (3),
amend the order to require a recall. The Secretary shall
specify a timetable in which the food recall will occur and
shall require periodic reports to the Secretary describing the
progress of the recall.
``(2) Certain actions.--An amended order under paragraph
(1) shall not include recall of a food from individuals.''.
SEC. 11. INSPECTION AND OTHER STANDARDS; APPLICABILITY, ENFORCEMENT;
CERTIFICATIONS.
Chapter IV of the Federal Food, Drug, and Cosmetic Act, as amended
by section 10 of this Act, is amended by adding at the end the
following:
``SEC. 419. INSPECTION AND OTHER STANDARDS; APPLICABILITY, ENFORCEMENT;
CERTIFICATIONS.
``(a) In General.--Notwithstanding any other provision of law, all
food that is offered for importation into the United States shall be
subject to the food safety standards applied to such food produced in
the United States.
``(b) Enforcement.--Any food that appears to not meet all the
standards referred to in subsection (a) shall be considered adulterated
and shall not be permitted entry into the United States.
``(c) Random Inspections.--The Secretary shall enforce this section
through appropriate random inspections, sampling, and testing.
``(d) Certifications Regarding Foreign Facilities.--
``(1) Requirement.--No food shall be permitted entry into
the United States from a foreign facility in a foreign country
unless there is--
``(A) a certification for such facility in effect
under paragraph (2)(A); or
``(B) a certification for such country under
paragraph (2)(B).
``(2) Certification.--
``(A) Foreign facility.--Each foreign facility
seeking to import food into the United States may
obtain a certification by the Secretary stating that
the facility maintains a program using reliable
analytical methods to ensure compliance with all the
standards referred to in subsection (a).
``(B) Foreign country.--A foreign country may
obtain a certification by the Secretary stating that--
``(i) the country has in effect and is
enforcing food safety standards at least as
protective of food safety as the standards
applicable to food in the United States; and
``(ii) the country has a program in effect
to monitor and enforce its food safety
standards with respect to food being exported
from such country to the United States.
``(3) Periodic review.--The Secretary shall periodically
review certifications under paragraph (2) and shall revoke any
certification if the Secretary determines that the foreign
facility or foreign country involved is no longer meeting the
requirements described in such paragraph.
``(4) Inspection.--The consideration of any application for
a certification under paragraph (2) and the review of any such
certification, by the Secretary, may include the inspection of
foreign facilities to ensure that the inspection program of the
foreign facility involved is meeting such standards.
``(5) Foreign facility.--In this subsection, the term
`foreign facility' means a foreign facility (as defined in
section 415(b)(3)) that is required to be registered under
section 415.
``(6) Effective date.--This subsection takes effect
beginning on the date that is 5 years after the date of the
enactment of the Food and Drug Import Safety Act of 2007.''.
SEC. 12. REGULATIONS ON ADEQUATE TESTING OF PROCESSED FOOD.
Chapter IV of the Federal Food, Drug, and Cosmetic Act, as amended
by section 11 of this Act, is amended by adding at the end the
following:
``SEC. 420. REGULATIONS ON ADEQUATE TESTING OF PROCESSED FOOD.
``(a) In General.--Not later than 2 years after the date of the
enactment of the Food and Drug Import Safety Act of 2007, the Secretary
shall by regulation require that, as good manufacturing practices,
processed food undergo testing to detect substances in the food that
may render the food adulterated, including microbial pathogens, toxic
chemicals, and such other substances as the Secretary determines to be
appropriate.
``(b) Review of Test Results.--Regulations under subsection (a)
shall require that the results of tests under such subsection be
provided to the Secretary upon demand.''.
SEC. 13. RECORDS OF INTERSTATE SHIPMENT.
Subsection (a) of section 703 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 373) is amended--
(1) by striking ``upon the request'' and inserting ``upon
the written or oral request''; and
(2) by striking ``, except that evidence obtained under
this section, or any evidence which is directly or indirectly
derived from such evidence, shall not be used in a criminal
prosecution of the person from whom obtained, and except that
carriers shall not be subject to the other provisions of this
Act by reason of their receipt, carriage, holding, or delivery
of food, drugs, devices, or cosmetics in the usual course of
business as carriers, except as provided in subsection (b)''.
SEC. 14. LABELING REQUIREMENT FOR MEAT, POULTRY PRODUCTS, AND SEAFOOD
THAT CONTAIN CARBON MONOXIDE.
(a) Labeling Requirement.--
(1) In general.--Paragraph (t) of section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(t)) is
amended by adding at the end the following new paragraph:
``(4) In the case of food that is meat within the meaning
of the Federal Meat Inspection Act, a poultry product within
the meaning of the Poultry Products Inspection Act, or seafood
(including all fresh or saltwater finfish, molluscan shellfish,
crustaceans, and other forms of aquatic animal life) intended
for human consumption as food within the meaning of section
201(f) of this Act (referred to collectively in this subsection
as `seafood'), the term `color additive' shall include carbon
monoxide under conditions of use that may impart, maintain,
preserve, stabilize, fix, or otherwise affect the color of
fresh meat, poultry products, or seafood, unless the label of
such food bears, prominently and conspicuously in such place
and in such manner as to render it likely to be read and
understood by the ordinary person, the following statement to
prevent consumer deception and serious risks to the public
health: `SAFETY NOTICE: Carbon monoxide has been used to
preserve the color of this product. Do not rely on color or the
``use or freeze by'' date alone to judge the freshness or
safety of the product. Discard any product with an unpleasant
odor, slime, or a bulging package.'''.
(2) Effective date.--The amendment made by this subsection
shall apply to food labeled on or after the date that is 30
days after the date of the enactment of this Act.
(b) Discretionary Authority.--If, not earlier than 5 years after
the effective date described in subsection (a)(1), the Secretary of
Health and Human Services finds, based on competent and reliable
scientific evidence, that the statement prescribed in section 201(t)(4)
of the Federal Food, Drug, and Cosmetic Act is no longer required to
prevent consumer deception and other harms, then the Secretary is
authorized to issue regulations establishing alternative labeling
requirements that are shown to be adequate and effective in preventing
consumer deception and other harms related to the conditions of use of
carbon monoxide, including with respect to preventing any consumer
deception or other harm that may result from the actual conditions of
carbon monoxide use and its potential to impart a persistent color to
meat, poultry products, or seafood described in such section through a
reaction with natural pigment.
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