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; certifi-
cations. 
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 INTEN-
TIONAL 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 (di-
rectly or through grants or contracts) provide for re-
search on the development of tests and sampling 
methodologies, for use in inspections of food under 
this section— 
‘‘(A) whose purpose is to determine wheth-
er food is adulterated by reason of being con-
taminated with microorganisms, chemical tox-
ins, or pesticide chemicals or related residues; 
and 
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‘‘(B) whose results are available not later 
than approximately 60 minutes after the ad-
ministration of the tests. 
‘‘(2) PRIORITY.—In providing for research 
under paragraph (1), the Secretary shall give pri-
ority 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 great-
est priority given to the development of such tests 
that the Secretary determines would be useful in de-
tecting the intentional adulteration of food. In pro-
viding for research under paragraph (1), the Sec-
retary shall under the preceding sentence give pri-
ority to conducting research on the development of 
tests for detecting the presence in food of the patho-
gens E. coli, salmonella, cyclospora, cryptosporidium, 
hepatitis A, or listeria, the presence in or on food of 
pesticide chemicals and related residues, the pres-
ence in or on food of chemical toxins, and the pres-
ence in or on food of such other pathogens or sub-
stances as the Secretary determines to be appro-
priate, including any pathogen or substance that the 
Secretary determines is a candidate for use to inten-
tionally adulterate food. The Secretary shall estab-
lish the goal of developing, by the expiration of the 
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3-year period beginning on the date of the enact-
ment of the this subsection, tests under paragraph 
(1) for each of the pathogens and substances receiv-
ing 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 re-
ferred 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 sub-
section. 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 Adminis-
trator of the Environmental Protection Agency. The 
Secretary shall with respect to such research coordi-
nate the activities of the Department of Health and 
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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 IM-
PORTED 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: 
‘‘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. 
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‘‘(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 90 percent for carrying out sec-
tion 801 with respect to food, other than 
research under section 801(p). In expend-
ing 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 inspec-
tions to detect the intentional adulteration 
of food. 
‘‘(ii) The Secretary shall reserve not 
more than 10 percent for carrying out re-
search under section 801(p). 
‘‘(C) 
LABORATORY
TESTING.—In 
this 
paragraph, the term ‘costs of carrying out sec-
tion 801’ with respect to food being imported or 
offered for import includes the costs of labora-
tory testing of such food, including laboratory 
personnel costs. 
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‘‘(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 $50 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 
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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 2008, 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-
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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 2008 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 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 sub-
section (f)(3) for the fiscal years involved; 
‘‘(B) the amounts appropriated under sec-
tion 801B(f)(3) for such fiscal years; and 
‘‘(C) 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-
sess such fees, the Secretary may assess and collect 
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such fees, without any modification in the rate of 
the fees, at any time in such fiscal year notwith-
standing 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 ex-
penses appropriation account without fiscal year lim-
itation to such appropriation account for salaries 
and expenses with such fiscal year limitation. The 
sums transferred shall be available solely for car-
rying 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 
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‘‘(B) shall only be collected and available 
for the purpose specified in subsection (a)(2). 
‘‘(3) AUTHORIZATION OF APPROPRIATIONS; AL-
LOCATIONS 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 appro-
priation account of the Food and Drug Administra-
tion as provided in paragraph (1), and shall be sub-
tracted from the amount of fees that would other-
wise be authorized to be collected under this section 
pursuant to appropriation Acts for a subsequent fis-
cal year. 
‘‘(g) COLLECTION OF UNPAID FEES.—In any case 
where the Secretary does not receive payment of a fee as-
sessed 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. 
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‘‘(h) CONSTRUCTION.—This section may not be con-
strued as requiring that the number of full-time equivalent 
positions in the Department of Health and Human Serv-
ices, 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’ ap-
plicable 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 IM-
PORTED DRUG SAFETY. 
Chapter VIII of the Federal Food, Drug, and Cos-
metic 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.— 
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‘‘(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 rev-
enue 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 de-
tect the intentional adulteration or mis-
branding of drugs; and 
‘‘(ii) inspections of good manufac-
turing practices conducted abroad. 
‘‘(C) 
LABORATORY
TESTING.—In 
this 
paragraph, the term ‘costs of carrying out sec-
tion 801’ with respect to drugs being imported 
or offered for import includes the costs of lab-
oratory testing of such drugs, including labora-
tory personnel costs. 
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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 2008, 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-
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tion 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 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 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 sub-
section (f)(3) for the fiscal years involved; 
‘‘(B) the amounts appropriated under sec-
tion 801A(f)(3) for such fiscal years; and 
‘‘(C) 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-
sess such fees, the Secretary may assess and collect 
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such fees, without any modification in the rate of 
the fees, at any time in such fiscal year notwith-
standing 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 ex-
penses appropriation account without fiscal year lim-
itation to such appropriation account for salaries 
and expenses with such fiscal year limitation. The 
sums transferred shall be available solely for car-
rying 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). 
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‘‘(3) AUTHORIZATION OF APPROPRIATIONS; AL-
LOCATIONS 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 appro-
priation account of the Food and Drug Administra-
tion as provided in paragraph (1), and shall be sub-
tracted from the amount of fees that would other-
wise be authorized to be collected under this section 
pursuant to appropriation Acts for a subsequent fis-
cal year. 
‘‘(g) COLLECTION OF UNPAID FEES.—In any case 
where the Secretary does not receive payment of a fee as-
sessed 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 con-
strued as requiring that the number of full-time equivalent 
positions in the Department of Health and Human Serv-
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ices, 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’ ap-
plicable 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 im-
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portation 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 con-
sequences 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 sub-
section.’’. 
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 Fed-
eral 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.’’. 
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‘‘(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 fol-
lowing: ‘‘Any person who introduces into interstate 
commerce or delivers for introduction into interstate 
commerce an article of food that is adulterated with-
in the meaning of section 402(a)(2)(B) shall be sub-
ject 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 
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any other person for such introduction or deliv-
ery, not to exceed $1,000,000 for all such viola-
tions 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 Af-
fairs 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 Ad-
ministration 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 in-
spection functions of any such district office to 
any other district. 
(b) REPORT BY SECRETARY.— 
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(1) SUBMISSION.—The Secretary shall submit a 
reorganization plan involving the termination or con-
solidation of the laboratories, the district offices, or 
the functions of such district offices specified in sub-
section (a) to the Comptroller General, the Com-
mittee on Energy and Commerce of the House of 
Representatives, and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate. 
(2) CONSULTATION.—In preparing the reorga-
nization plan described in paragraph (1), the Sec-
retary 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 Com-
merce of the House of Representatives and the Committee 
on Health, Education, Labor, and Pensions of the Senate. 
(d) REORGANIZATION.— 
(1) CONGRESSIONAL REVIEW.—The reorganiza-
tion plan described in subsection (b) is deemed to be 
a major rule (as defined in section 804(2) of title 5, 
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United States Code) for purposes of chapter 8 of 
such title. 
(2) EFFECTIVE
DATE.—Notwithstanding sec-
tion 801(a)(3) of title 5, United States Code, the re-
organization 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 con-
sequences or death, the Secretary shall issue an 
order requiring the appropriate person (including 
the manufacturers, importers, distributors, or retail-
ers 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, 
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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 op-
portunity 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 Sec-
retary 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.’’. 
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SEC. 11. INSPECTION AND OTHER STANDARDS; APPLICA-
BILITY, 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; APPLICA-
BILITY, ENFORCEMENT; CERTIFICATIONS. 
‘‘(a) IN GENERAL.—Notwithstanding any other pro-
vision of law, all food that is offered for importation into 
the United States shall be subject to the food safety stand-
ards 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 inspec-
tions, sampling, and testing. 
‘‘(d) CERTIFICATIONS REGARDING FOREIGN FACILI-
TIES.— 
‘‘(1) REQUIREMENT.—No food shall be per-
mitted entry into the United States from a foreign 
facility in a foreign country unless there is— 
‘‘(A) a certification for such facility in ef-
fect under paragraph (2)(A); or 
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and shall revoke any certification if the Secretary 
determines that the foreign facility or foreign coun-
try 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 Sec-
retary, may include the inspection of foreign facili-
ties to ensure that the inspection program of the for-
eign 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 PROC-
ESSED 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: 
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‘‘SEC. 420. REGULATIONS ON ADEQUATE TESTING OF PROC-
ESSED FOOD. 
‘‘(a) IN GENERAL.—Not later than 2 years after the 
date of the enactment of the Food and Drug Import Safe-
ty Act of 2007, the Secretary shall by regulation require 
that, as good manufacturing practices, processed food un-
dergo testing to detect substances in the food that may 
render the food adulterated, including microbial patho-
gens, 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 insert-
ing ‘‘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, 
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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 poul-
try product within the meaning of the Poultry Prod-
ucts 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 addi-
tive’ shall include carbon monoxide under conditions 
of use that may impart, maintain, preserve, stabilize, 
fix, or otherwise affect the color of fresh meat, poul-
try products, or seafood, unless the label of such 
food bears, prominently and conspicuously in such 
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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 pre-
serve 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 prod-
uct 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 sub-
section (a)(1), the Secretary of Health and Human Serv-
ices finds, based on competent and reliable scientific evi-
dence, 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 estab-
lishing alternative labeling requirements that are shown 
to be adequate and effective in preventing consumer de-
ception and other harms related to the conditions of use 
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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. 
Æ 
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