I 
111TH CONGRESS 
1ST SESSION 
H. R. 999 
To amend the Federal Food, Drug, and Cosmetic Act to improve food safety. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 11, 2009 
Mr. ROSKAM (for himself and Mr. KIRK) 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 to 
improve food safety. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Keeping America’s 
Food Safe Act of 2009’’. 
SEC. 2. CERTIFICATION OF PRIVATE LABORATORIES AND 
SAMPLING SERVICES. 
(a) AMENDMENT.—Chapter IV of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amend-
ed by adding at the end the following: 
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‘‘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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‘‘(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.—Paragraph (1) does not apply if the Sec-
retary determines that the certification process de-
scribed in subsection (d) is not needed for the Sec-
retary’s evaluation of whether the facility’s or coun-
try’s standards for food safety, inspection, labeling, 
and consumer protection are at least equivalent 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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‘‘(B) 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, ensuring that the 
food products intended for export to the United 
States are safe for human consumption, and 
not adulterated or misbranded. 
‘‘(e) AGREEMENTS WITH FOREIGN NATIONS.—Any 
certification of a foreign country under subsection (d)(2) 
shall— 
‘‘(1) require the foreign country to promptly no-
tify the Secretary of any violations affecting the 
safety of food products exported or intended for ex-
port to the United States; 
‘‘(2) provide for such activities (whether in the 
foreign country or at the port of entry during impor-
tation) by the Secretary, including analysis, testing, 
and sampling, at such stages in the growth or har-
vest of food, or in the processing or handling of food 
products, as the Secretary considers appropriate to 
ensure that the foreign 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 
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‘‘(3) provide for reciprocity with respect to the 
treatment of food imports and exports between the 
United States and the foreign country. 
‘‘(f) DOCUMENTATION.—The Secretary shall provide 
to the Congress annual documentation demonstrating the 
Secretary’s confidence in the standards of any foreign fa-
cility or country for which the Secretary has made a deter-
mination under paragraph (2) of subsection (c). 
‘‘(g) REVOCATION
OF CERTIFICATION.—The Sec-
retary may, with respect to a foreign facility or foreign 
country, revoke a certification under subsection (d) if— 
‘‘(1) food from the foreign facility or foreign 
country is linked to an outbreak of human illness; 
‘‘(2) the Secretary determines that the foreign 
facility or foreign country is no longer meeting the 
requirements described in subsection (d); or 
‘‘(3) United States officials are not allowed to 
conduct such audits and investigations as may be 
necessary to carry out this section. 
‘‘(h) DURATION OF CERTIFICATION.—Each certifi-
cation under subsection (d) shall be for a period of not 
more than 5 years. 
‘‘(i) INSPECTION; INDEPENDENT AUDITS.— 
‘‘(1) AUTHORIZATION.—In determining whether 
to issue a certification under subsection (d) or re-
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voke a certification under subsection (g), the Sec-
retary is authorized to— 
‘‘(A) inspect foreign facilities to ensure 
compliance with the food safety standards de-
scribed in subsection (a); and 
‘‘(B) consider independent audits, product 
test data, and other relevant information gen-
erated by the facility, importer, or foreign coun-
try involved. 
‘‘(2) RENEWAL OF CERTIFICATION.—The Sec-
retary shall audit foreign countries and foreign fa-
cilities at least every 5 years to ensure the continued 
compliance with the standards set forth in this sec-
tion. 
‘‘(j) ENFORCEMENT.—The Secretary is authorized 
to— 
‘‘(1) deny importation of food from any foreign 
country that does not permit United States officials 
to enter the foreign country to conduct such audits 
and inspections as may be necessary to fulfill the re-
quirements of this section; 
‘‘(2) deny importation of food from any foreign 
country or foreign facility that does not consent to 
an investigation by the Secretary when food from 
that foreign country or foreign facility is linked to 
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a food-borne illness outbreak or is otherwise found 
to be adulterated or mislabeled; and 
‘‘(3) promulgate rules and regulations to carry 
out the purposes of this section, including setting 
terms and conditions for the destruction of products 
that fail to meet the standards of this Act. 
‘‘(k) FOREIGN FACILITY.—In this section, the term 
‘foreign facility’ means a foreign facility (as defined in sec-
tion 415(b)(3)) that is required to be registered under sec-
tion 415.’’. 
(b) TRANSITIONAL PROGRAM.—Not later than 180 
days after the date of enactment of this Act, the Secretary 
shall promulgate regulations to establish a transitional 
food safety import review program, with minimal disrup-
tion to commerce, that shall be in effect until the date 
of implementation of the food import certification program 
under section 805 of the Federal Food, Drug, and Cos-
metic Act, as added by subsection (a) of this section. 
SEC. 4. INFORMATION CLEARINGHOUSES. 
Chapter IV of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 341 et seq.), as amended by section 2 of 
this Act, is amended by adding at the end the following: 
‘‘SEC. 419. INFORMATION CLEARINGHOUSES. 
‘‘(a) WEBSITE ON FOOD SAFETY ISSUES.— 
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‘‘(1) IN GENERAL.—The Secretary, in consulta-
tion with the Secretary of Agriculture, shall develop 
and maintain a Website with public information 
that— 
‘‘(A) provides information on Federal food 
standards and best practice requirements for 
food preparation; 
‘‘(B) assists health professionals to im-
prove their ability— 
‘‘(i) to diagnose and treat food-related 
illness; and 
‘‘(ii) to advise individuals whose 
health conditions place them at particular 
risk; and 
‘‘(C) promotes the public awareness of food 
safety issues. 
‘‘(2) RESOURCES.—The Secretary shall utilize 
the resources of the Food and Drug Administration 
and the Centers for Disease Control and Prevention 
to carry out this subsection. 
‘‘(b) WEBSITE ON SCHOOL CURRICULA REGARDING 
FOOD SAFETY.—The Secretary, in consultation with the 
Secretary of Education, shall develop and maintain a 
Website to provide the public with appropriate information 
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on developing school curriculum regarding food safety 
issues.’’. 
SEC. 5. WHISTLEBLOWER PROTECTION. 
Chapter IV of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 341 et seq.), as amended by sections 2 
and 4 of this Act, is amended by adding at the end the 
following: 
‘‘SEC. 420. WHISTLEBLOWER PROTECTION. 
‘‘(a) PROHIBITION.—No employee or other person 
may be harassed, prosecuted, held liable, or discriminated 
against in any way because that person— 
‘‘(1) has commenced, caused to be commenced, 
or is about to commence a proceeding, testified or is 
about to testify at a proceeding, or assisted or par-
ticipated or is about to assist or participate in any 
manner in such a proceeding or in any other action 
to carry out the purposes, functions, or responsibil-
ities of this Act; or 
‘‘(2) is refusing to violate or assist in violation 
of this Act. 
‘‘(b) PROCEDURES.—The process and procedures 
with respect to prohibited discrimination under subsection 
(a) shall be governed by the applicable provisions of sec-
tion 31105 of title 49, United States Code, unless the 
party bringing an action under this subsection chooses al-
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ternative dispute resolution procedures such as mediation 
or arbitration. 
‘‘(c) BURDENS OF PROOF.—The legal burdens of 
proof with respect to prohibited discrimination under sub-
section (a) shall be governed by the applicable provisions 
of sections 1214 and 1221 of title 5, United States 
Code.’’. 
SEC. 6. REPORTABLE FOOD REGISTRY. 
(a) RESPONSIBLE PARTIES.—Paragraph (1) of sec-
tion 417(a) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 350f(a)) is amended to read as follows: 
‘‘(1) RESPONSIBLE PARTY.—The term ‘respon-
sible party’, with respect to an article of food, means 
a person that— 
‘‘(A) submits the registration under section 
415(a) for a food facility that is required to 
register under section 415(a), at which such ar-
ticle of food is manufactured, processed, 
packed, or held; or 
‘‘(B) is an establishment that analyzes or 
tests samples of food for consumption in the 
United States to ensure the safety of such 
food.’’. 
(b) INDIVIDUAL ANALYSIS OR TEST.—Subsection (d) 
of section 417 of the Federal Food, Drug, and Cosmetic 
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