I 
111TH CONGRESS 
1ST SESSION H. R. 2749 
To amend the Federal Food, Drug, and Cosmetic Act to improve the safety 
of food in the global market, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 8, 2009 
Mr. DINGELL (for himself, Mr. WAXMAN, Mr. PALLONE, Mr. STUPAK, Ms. 
DEGETTE, and Ms. SUTTON) introduced the following bill; which was re-
ferred to the Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
improve the safety of food in the global market, and 
for other purposes. 
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 ‘‘Food Safety Enhance-
ment Act of 2009’’. 
SEC. 2. TABLE OF CONTENTS. 
The table of contents of this Act is as follows: 
Sec. 1. Short title. 
Sec. 2. Table of contents. 
Sec. 3. References. 
Sec. 4. Rule of construction. 
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TITLE I—FOOD SAFETY 
Subtitle A—Prevention 
Sec. 101. Changes in registration of food facilities. 
Sec. 102. Hazard analysis, risk-based preventive controls, and food safety plan. 
Sec. 103. Performance standards. 
Sec. 104. Safety standards for fresh produce and certain other raw agricultural 
commodities. 
Sec. 105. Risk-based inspection schedule. 
Sec. 106. Access to records. 
Sec. 107. Traceability of food. 
Sec. 108. Reinspection and food recall fees applicable to facilities. 
Sec. 109. Certification and accreditation. 
Sec. 110. Testing by accredited laboratories. 
Sec. 111. Notification, nondistribution, and recall of adulterated or misbranded 
food. 
Sec. 112. Reportable food registry; exchange of information. 
Sec. 113. Safe and secure food importation program. 
Sec. 114. Infant formula. 
Subtitle B—Intervention 
Sec. 121. Public health assessment system. 
Sec. 122. Public education and advisory system. 
Sec. 123. Research. 
Subtitle C—Response 
Sec. 131. Procedures for seizure. 
Sec. 132. Administrative detention. 
Sec. 133. Quarantine authority for foods. 
Sec. 134. Criminal penalties. 
Sec. 135. Civil penalties for violations relating to food. 
Sec. 136. Improper import entry filings. 
TITLE II—MISCELLANEOUS 
Sec. 201. Treatment of carbon monoxide used to preserve color of meat, poultry 
products, or seafood as color additive. 
Sec. 202. Food substances generally recognized as safe. 
Sec. 203. Country of origin labeling; disclosure of source of ingredients. 
Sec. 204. Exportation certificate program. 
Sec. 205. Registration for commercial importers of food; fee. 
Sec. 206. Unique identification number for food facilities, importers, custom 
brokers, and filers. 
Sec. 207. Prohibition against delaying, limiting, or refusing inspection. 
Sec. 208. Dedicated foreign inspectorate. 
Sec. 209. Plan and review of continued operation of field laboratories. 
Sec. 210. False or misleading reporting to FDA. 
Sec. 211. Subpoena authority. 
Sec. 212. Whistleblower protections. 
Sec. 213. Extraterritorial jurisdiction. 
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SEC. 3. REFERENCES. 
Except as otherwise specified, whenever in this Act 
an amendment is expressed in terms of an amendment to 
a section or other provision, the reference shall be consid-
ered to be made to a section or other provision of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.). 
SEC. 4. RULE OF CONSTRUCTION. 
Nothing in this Act or the amendments made by this 
Act shall be construed to prohibit or limit— 
(1) any cause of action under State law; or 
(2) the introduction of evidence of compliance 
or noncompliance with the requirements of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 
et seq.). 
TITLE I—FOOD SAFETY 
Subtitle A—Prevention 
SEC. 101. CHANGES IN REGISTRATION OF FOOD FACILI-
TIES. 
(a) MISBRANDING.—Section 403 (21 U.S.C. 343) is 
amended by adding at the end the following: 
‘‘(z) If it was manufactured, processed, packed, or 
held in a facility that is not duly registered under section 
415, including a facility whose registration is canceled or 
suspended under such section.’’. 
(b) ANNUAL REGISTRATION.— 
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(1) IN GENERAL.—Section 415(a) (21 U.S.C. 
350d(a)) is amended— 
(A) in the first sentence of paragraph 
(1)— 
(i) by striking ‘‘require that’’ and in-
serting ‘‘require that, on or before Decem-
ber 31 of each year,’’; and 
(ii) by striking ‘‘food for consumption 
in the United States’’ and inserting ‘‘food 
for consumption in the United States or 
for export from the United States’’; 
(B) in subparagraphs (A) and (B) of para-
graph (1), by inserting ‘‘and pay the registra-
tion fee required under section 743’’ after ‘‘sub-
mit a registration to the Secretary’’ each place 
it appears; 
(C) in the first sentence of paragraph (2), 
by inserting ‘‘in electronic format’’ after ‘‘sub-
mit’’; and 
(D) in paragraph (4), by inserting after 
the first sentence the following: ‘‘The Secretary 
shall remove from such list the name of any fa-
cility that fails to reregister in accordance with 
this section, that fails to pay the registration 
fee required under section 743, or whose reg-
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