IB 
Union Calendar No. 130 
111TH CONGRESS 
1ST SESSION H. R. 2749 
[Report No. 111–234] 
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 
JULY 29, 2009 
Reported with an amendment, committed to the Committee of the Whole 
House on the State of the Union, and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on June 8, 2009] 
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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. 
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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. Rules of construction. 
Sec. 5. USDA exemptions. 
Sec. 6. Alcohol-related facilities. 
TITLE I—FOOD SAFETY 
Subtitle A—Prevention 
Sec. 101. Changes in registration of food facilities. 
Sec. 102. Hazard analysis, risk-based preventive controls, food safety plan, fin-
ished product test results from category 1 facilities. 
Sec. 103. Performance standards. 
Sec. 104. Safety standards for produce and certain other raw agricultural com-
modities. 
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. Surveillance. 
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. 
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Sec. 135. Civil penalties for violations relating to food. 
Sec. 136. Improper import entry filings. 
TITLE II—MISCELLANEOUS 
Sec. 201. Food substances generally recognized as safe. 
Sec. 202. Country of origin labeling; disclosure of source of ingredients. 
Sec. 203. Exportation certificate program. 
Sec. 204. Registration for commercial importers of food; fee. 
Sec. 205. Registration for customs brokers and filers; fee. 
Sec. 206. Unique identification number for food facilities, importers, custom bro-
kers, 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. 
Sec. 214. Support for training institutes. 
Sec. 215. Bisphenol A in food and beverage containers. 
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 considered 
to be made to a section or other provision of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). 
SEC. 4. RULES OF CONSTRUCTION. 
(a) Nothing in this Act or any amendment 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 Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). 
(b) Nothing in this Act or any amendment made by 
this Act shall be construed to— 
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(1) alter the jurisdiction between the Secretary of 
Agriculture and the Secretary of Health and Human 
Services, under applicable statutes and regulations; 
(2) limit the authority of the Secretary of Health 
and Human Services to issue regulations related to 
the safety of food under— 
(A) the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 301 et seq.) as in effect on the 
day before the date of the enactment of this Act; 
or 
(B) the Public Health Service Act (42 
U.S.C. 301 et seq.) as in effect on the day before 
the date of the enactment of this Act; or 
(3) impede, minimize, or affect the authority of 
the Secretary of Agriculture to prevent, control, or 
mitigate a plant or animal health emergency, or a 
food emergency involving products regulated under 
the Federal Meat Inspection Act (21 U.S.C. 601 et 
seq.), the Poultry Products Inspection Act (21 U.S.C. 
451 et seq.), or the Egg Products Inspection Act (21 
U.S.C. 1031 et seq.). 
SEC. 5. USDA EXEMPTIONS. 
(a) USDA-REGULATED PRODUCTS.—Food is exempt 
from the requirements of this Act if such food is regulated 
by the Secretary of Agriculture under the Federal Meat In-
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spection Act, the Poultry Products Inspection Act, or the 
Egg Products Inspection Act. 
(b) USDA-REGULATED FACILITIES.—A facility is ex-
empt from the requirements of this Act if such facility is 
regulated exclusively as an official establishment by the Sec-
retary of Agriculture under the Federal Meat Inspection 
Act, the Poultry Products Inspection Act, or the Egg Prod-
ucts Inspection Act. 
(c) FARMS.—A farm is exempt from the requirements 
of this Act to the extent such farm raises animals from 
which food is derived that is regulated under the Federal 
Meat Inspection Act, the Poultry Products Inspection Act, 
or the Egg Products Inspection Act. 
SEC. 6. ALCOHOL-RELATED FACILITIES. 
(a) IN GENERAL.—With the exception of the amend-
ments made by section 101(a) and (b) and section 113 of 
this Act, nothing in this Act, or the amendments made by 
this Act, shall be construed to apply to a facility that— 
(1) under the Federal Alcohol Administration 
Act or chapter 51 of subtitle E of the Internal Rev-
enue Code, is required to obtain a permit or to reg-
ister with the Secretary of the Treasury as a condi-
tion of doing business in the United States; and 
(2) under section 415 of the Federal Food, Drug, 
and Cosmetic Act, as amended by this Act, is required 
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