—I 
111TH CONGRESS 
1ST SESSION 
H. R. 759 
To amend the Federal Food, Drug, and Cosmetic Act to improve the safety 
of food, drugs, devices, and cosmetics in the global market, and for 
other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JANUARY 28, 2009 
Mr. DINGELL (for himself, Mr. STUPAK, and Mr. PALLONE) 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 the safety of food, drugs, devices, and cosmetics 
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; REFERENCES; TABLE OF CON-
TENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Food and Drug Administration Globalization Act of 
2009’’. 
(b) REFERENCES TO THE FEDERAL FOOD, DRUG, 
AND COSMETIC ACT.—Except as otherwise specified, 
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whenever in this Act an amendment is expressed in terms 
of an amendment to a section or other provision, the ref-
erence 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.). 
(c) TABLE OF CONTENTS.—The table of contents of 
this Act is as follows: 
Sec. 1. Short title; references; table of contents. 
Sec. 2. Relationship to State law. 
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. 
Sec. 105. Risk-based inspection. 
Sec. 106. Access to records. 
Sec. 107. Traceability of food. 
Sec. 108. Reinspection fee applicable to facilities. 
Sec. 109. Certification of food facilities. 
Sec. 110. Safe and secure food importation program. 
Subtitle B—Intervention 
Sec. 111. Public health assessment system. 
Sec. 112. Public education and advisory system. 
Sec. 113. Research. 
Sec. 114. Notification, nondistribution, and recall of adulterated or misbranded 
articles of food. 
Subtitle C—Response 
Sec. 121. Administrative detention. 
Sec. 122. Civil penalties relating to food. 
Sec. 123. Failure to consent to investigation. 
Subtitle D—Miscellaneous 
Sec. 131. Labeling requirement for meat, poultry products, and seafood that 
contain carbon monoxide. 
Sec. 132. Food substances generally recognized as safe. 
Sec. 133. Country of origin labeling; disclosure of source of ingredients. 
Sec. 134. New food and animal feed export certification fee to improve the abil-
ity of United States firms to export their products. 
TITLE II—DRUG AND DEVICE SAFETY 
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Sec. 201. Registration of producers of drugs and devices; applicable fee. 
Sec. 202. Inspection of producers of drugs and active pharmaceutical ingredi-
ents. 
Sec. 203. Documentation for admissibility of drug imports. 
Sec. 204. Drug supply quality and safety. 
Sec. 205. Delay, limitation, or denial of inspection. 
Sec. 206. Country of origin labeling. 
Sec. 207. Nondistribution and recall of adulterated or misbranded drugs. 
Sec. 208. Destruction of adulterated, misbranded or counterfeit articles offered 
for import. 
Sec. 209. Administrative detention of drugs that appear to violate the law. 
Sec. 210. Penalties regarding counterfeit drugs. 
Sec. 211. Civil money penalties for violative drugs and devices and improper 
import entry filings. 
Sec. 212. Human generic drug application and supplement fees to cover pre- 
approval inspection costs. 
TITLE III—COSMETIC SAFETY 
Sec. 301. Registration of cosmetic establishments. 
Sec. 302. Cosmetic and ingredient statements. 
Sec. 303. Serious and unexpected adverse event reports for cosmetics. 
Sec. 304. Good manufacturing practices for cosmetics. 
Sec. 305. Authorization of appropriations. 
Sec. 306. Effective date. 
TITLE IV—MISCELLANEOUS 
Sec. 401. Registration for commercial importers of food, drugs, devices, and 
cosmetics; fee. 
Sec. 402. Unique identification number for food, drug, and device facilities and 
establishments. 
Sec. 403. Prohibition against delaying or limiting inspection. 
Sec. 404. Dedicated foreign inspectorate. 
Sec. 405. Continued operation of field laboratories. 
Sec. 406. False or misleading reporting to FDA. 
Sec. 407. Subpoena authority. 
Sec. 408. Whistleblower protections. 
SEC. 2. RELATIONSHIP TO STATE LAW. 
This Act and the amendments made by this Act may 
not be construed as modifying or otherwise affecting any 
action or the liability of any person (as defined in section 
201 of the Federal Food, Drug, and Cosmetic Act) under 
the law of any State. 
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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 or is in violation of section 741 (requiring payment 
of a fee for such registration).’’. 
(b) ANNUAL REGISTRATION AND PAYMENT OF REG-
ISTRATION FEE.— 
(1) IN GENERAL.—Section 415(a) (21 U.S.C. 
350d(a)) is amended— 
(A) in the first sentence of paragraph (1), 
by inserting ‘‘annually’’ after ‘‘be registered’’; 
(B) in paragraph (1), by inserting ‘‘and 
pay the registration fee required under section 
741’’ after ‘‘submit a registration to the Sec-
retary’’ each place it appears in subparagraphs 
(A) and (B); and 
(C) 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 
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this section and shall treat such removal as a 
suspension of the facility’s registration.’’. 
(2) REGISTRATION
FEE.—Chapter VII (21 
U.S.C. 371 et seq.) is amended— 
(A) by redesignating sections 741 and 742 
as sections 744 and 745, respectively; and 
(B) by adding at the end of subchapter C 
the following: 
‘‘PART 5—FEES RELATING TO FOOD 
‘‘SEC. 741. FACILITY REGISTRATION FEE. 
‘‘(a) IN GENERAL.—The Secretary shall assess and 
collect a fee for a facility registration under section 415 
to 
defray 
increases 
(as 
described 
in 
subsection 
(f)(2)(A)(ii)) in the costs of inspecting establishments reg-
istered under section 415 and for related activities to en-
sure compliance by such establishments with the require-
ments of this Act relating to food (including increases in 
such costs for management of information, and the acqui-
sition, maintenance, and repair of information technology 
resources). 
‘‘(b) FEE REVENUE AMOUNTS.— 
‘‘(1) IN
GENERAL.—For each of fiscal years 
2010 through 2014, fees under subsection (a) shall, 
except as provided in subsections (c), (e), and (f), be 
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