‘‘SEC. 418. FOOD SAFETY LABORATORIES AND SAMPLING 
SERVICES. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) FOOD
SAFETY
LABORATORY.—The term 
‘food safety laboratory’ means an establishment that 
analyzes or tests samples of imported food to ensure 
the safety of such food. 
‘‘(2) SAMPLING SERVICE.—The term ‘sampling 
service’ means an establishment that collects sam-
ples of an imported food. 
‘‘(b) CERTIFICATION REQUIREMENT.— 
‘‘(1) IN GENERAL.—Any entity that is a food 
safety laboratory or a sampling service shall submit 
to the Secretary an application for certification. 
Upon review, the Secretary may grant or deny cer-
tification to the food safety laboratory or sampling 
service. 
‘‘(2) CERTIFICATION
STANDARDS.—The Sec-
retary shall establish criteria and methodologies for 
the evaluation of an application for certification sub-
mitted under paragraph (1). Such criteria shall in-
clude the requirements that a food safety laboratory 
or sampling service— 
‘‘(A) be accredited as being in compliance 
with standards set by the International Organi-
zation for Standardization; 
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‘‘(B) agree to permit the Secretary to con-
duct an inspection of the facilities of the food 
safety laboratory or sampling service and the 
procedures of such facilities before making a 
certification determination; 
‘‘(C) agree to permit the Secretary to con-
duct routine audits of the facilities to ensure 
ongoing compliance with accreditation and cer-
tification requirements; 
‘‘(D) submit with such application a fee es-
tablished by the Secretary in an amount suffi-
cient to cover the cost of application review, in-
cluding inspection; and 
‘‘(E) agree to submit to the Secretary, in 
accordance with the process established, the re-
sults of tests conducted by such food safety lab-
oratory or sampling service on behalf of an im-
porter. 
‘‘(c) SUBMISSION
OF TEST RESULTS.—The Sec-
retary shall establish a process by which a food safety lab-
oratory or sampling service certified under this section 
shall submit to the Secretary the results of all tests con-
ducted by such food safety laboratory or sampling service 
on behalf of an importer. 
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‘‘(d) CERTIFICATION OF IMPORTERS FOR TESTING 
AND SAMPLING OWN PRODUCTS.—An importer shall not 
be federally certified for the purposes of analyzing, testing, 
or sampling its own food products for import unless the 
Secretary establishes a process under this section by which 
an importer can become certified for such purposes.’’. 
(b) ENFORCEMENT.—Section 303(f) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)) is 
amended— 
(1) by redesignating paragraphs (5), (6), and 
(7) as paragraphs (7), (8), and (9), respectively; 
(2) by inserting after paragraph (4) the fol-
lowing: 
‘‘(5) An importer (as such term is used in section 
418) shall be subject to a civil penalty in an amount not 
to exceed $1,000,000 if such importer knowingly engages 
in the falsification of test results submitted to the Sec-
retary by a food safety laboratory or sampling service cer-
tified under section 418. 
‘‘(6) A food safety laboratory or sampling service cer-
tified under section 418 shall be subject to a civil penalty 
in an amount not to exceed $1,000,000 for knowingly sub-
mitting to the Secretary false test results under section 
418.’’. 
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(3) in paragraph (2)(C), by striking ‘‘paragraph 
(5)(A)’’ and inserting ‘‘paragraph (7)(A)’’; 
(4) in paragraph (7), as so redesignated, by 
striking ‘‘paragraph (1), (2), (3), or (4)’’ each place 
it appears and inserting ‘‘paragraph (1), (2), (3), 
(4), (5), or (6)’’; 
(5) in paragraph (8), as so redesignated, by 
striking ‘‘paragraph (5)(A)’’ and inserting ‘‘para-
graph (7)(A)’’; and 
(6) in paragraph (9), by striking ‘‘paragraph 
(6)’’ each place it appears and inserting ‘‘paragraph 
(8)’’. 
SEC. 3. FOREIGN CERTIFICATION AND EQUIVALENCY. 
(a) AMENDMENT.—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. CERTIFICATION OF FOOD IMPORTERS. 
‘‘(a) IN GENERAL.—Not later than 2 years after the 
date of enactment of this section, the Secretary shall es-
tablish a certification program in accordance with this sec-
tion to ensure that food imported into the United States 
meets the food safety standards applied to food produced 
in the United States. 
‘‘(b) CERTIFICATION STANDARD.—A foreign facility 
or foreign country requesting a certification to import food 
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to the United States shall demonstrate, in a manner deter-
mined appropriate by the Secretary, that food produced 
under the supervision of the foreign facility or foreign 
country has met standards for food safety, inspection, la-
beling, and consumer protection that are at least equiva-
lent to standards applicable to food produced in the 
United States. In determining whether standards are so 
equivalent, the Secretary shall consider— 
‘‘(1) the potential for health, sanitary, environ-
mental, or other conditions within the foreign coun-
try involved to adversely affect the safety of food 
products exported from such nation; and 
‘‘(2) how well the food safety programs of the 
foreign country function to minimize any adverse ef-
fects on such safety. 
‘‘(c) REQUIREMENT OF CERTIFICATION FOR IMPORT-
ING.— 
‘‘(1) IN GENERAL.—Except as provided in para-
graph (2), 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 ef-
fect under subsection (d)(1); or 
‘‘(B) a certification for such country in ef-
fect under subsection (d)(2). 
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‘‘(2) EQUIVALENCY
DETERMINATION
BY
SEC-
RETARY.—Notwithstanding paragraph (1), the Sec-
retary shall have authority, to determine that the 
certification process under subsection (d) is not 
needed for the Secretary’s understanding of the fa-
cility’s or country’s standards for food safety, in-
spection, labeling, and consumer protection for food 
imported to the United States to be at least equiva-
lent to standards applicable to food produced in the 
United States. 
‘‘(d) CERTIFICATION.— 
‘‘(1) 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 ana-
lytical methods to ensure compliance with all the 
food safety standards described in subsection (a) to 
import such food. 
‘‘(2) FOREIGN
COUNTRY.—A foreign country 
may obtain a certification by the Secretary stating 
that— 
‘‘(A) the country has in effect and is en-
forcing food safety standards at least as protec-
tive of food safety as the standards applicable 
to food in the United States; and 
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