‘‘(ee) If it is imported or offered for import by an 
importer or a customs broker or filer not duly registered 
under section 801(r).’’. 
(3) REGISTRATION.—Section 801, as amended 
by sections 109 and 136, is amended by adding at 
the end the following: 
‘‘(r) REGISTRATION OF IMPORTERS AND CUSTOMS 
BROKERS AND FILERS.— 
‘‘(1) IMPORTERS.— 
‘‘(A) REGISTRATION.—The Secretary shall 
require an importer of food— 
‘‘(i) to be registered with the Sec-
retary in a form and manner specified by 
the Secretary; and 
‘‘(ii) consistent with section 911, to 
submit appropriate unique facility identi-
fiers as a condition of registration. 
‘‘(B) GOOD
IMPORTER
PRACTICES.—The 
maintenance of registration under this para-
graph is conditioned on compliance with good 
importer practices. Good importer practices 
shall include the verification of good manufac-
turing practices and preventive controls of the 
importer’s foreign suppliers, as applicable. 
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‘‘(2) CUSTOMS
BROKERS
AND
FILERS.—The 
Secretary shall require a customs broker or filer, 
with respect to the importation of food— 
‘‘(A) to be registered with the Secretary in 
a form and manner specified by the Secretary; 
and 
‘‘(B) consistent with section 911, to submit 
appropriate unique facility identifiers as a con-
dition of registration. 
‘‘(3) SUSPENSION OF REGISTRATION.— 
‘‘(A) IN
GENERAL.—Registration under 
this subsection is subject to suspension upon a 
finding by the Secretary, after notice and an 
opportunity for an informal hearing, of— 
‘‘(i) a violation of this Act; or 
‘‘(ii) the making of an inaccurate or 
incomplete statement or submission of in-
formation relating to the importation of 
food, drugs, or devices. 
‘‘(B) REQUEST.—The importer, customs 
broker, or filer whose registration is suspended 
may request that the Secretary vacate the sus-
pension of registration when such importer, 
customs broker, or filer has corrected the viola-
tion that is the basis for such suspension. 
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‘‘(C) VACATING OF SUSPENSION.—If the 
Secretary determines that adequate reasons do 
not exist to continue the suspension of a reg-
istration, the Secretary shall vacate such sus-
pension. 
‘‘(4) CANCELLATION OF REGISTRATION.— 
‘‘(A) IN GENERAL.—Not earlier than 10 
days after providing the notice under subpara-
graph (B), the Secretary may cancel a registra-
tion that the Secretary determines was not up-
dated in accordance with this section or other-
wise contains false, incomplete, or inaccurate 
information. 
‘‘(B) NOTICE
OF
CANCELLATION.—Can-
cellation shall be preceded by notice to the im-
porter, customs broker, or filer of the intent to 
cancel the registration and the basis for such 
cancellation. 
‘‘(C) TIMELY UPDATE OR CORRECTION.— 
If the registration for the importer, customs 
broker, or filer is updated or corrected no later 
than 7 days after notice is provided under sub-
paragraph (B), the Secretary shall not cancel 
such registration. 
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‘‘(5) EXEMPTIONS.—The Secretary, by notice 
published in the Federal Register— 
‘‘(A) shall establish an exemption from the 
requirements of this subsection for importations 
for personal use; and 
‘‘(B) may establish other exemptions from 
the requirements of this subsection.’’. 
(4) REGULATIONS.—Not later than 24 months 
after the date of the enactment of this Act, the Sec-
retary of Health and Human Services shall promul-
gate the regulations required to carry out section 
801(r). 
(5) EFFECTIVE DATE.—The amendments made 
by this subsection shall take effect on the date that 
is 24 months after the date of enactment of this Act. 
(b) FEE.—Subchapter C of chapter VII (21 U.S.C. 
379f et seq.) as added and amended by sections 101 and 
108, is amended by adding at the end the following: 
‘‘PART 7—IMPORTERS OF FOOD 
‘‘SEC. 744. IMPORTERS OF FOOD. 
‘‘(a) IMPORTERS.—The Secretary shall assess and 
collect an annual fee for the registration of an importer 
of food under section 801(r). 
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‘‘(b) CUSTOMS BROKERS AND FILERS.—The Sec-
retary shall assess and collect an annual fee for the reg-
istration of a customs broker or filer under section 801(r). 
‘‘(c) AMOUNT OF FEE.— 
‘‘(1) BASE AMOUNTS.—For fiscal year 2010, 
the Secretary shall, subject to paragraph (4), deter-
mine the amount of the fees under this section for 
importers, customs brokers, and filers. 
‘‘(2) ADJUSTMENT.—For fiscal year 2011 and 
subsequent fiscal years, the fees established pursu-
ant to paragraph (1) shall be adjusted by the Sec-
retary by notice, published in the Federal Register, 
for a fiscal year to reflect the greater of— 
‘‘(A) the total percentage change that oc-
curred in the Consumer Price Index for all 
urban consumers (all items; United States city 
average), for the 12-month period ending June 
30 preceding the fiscal year for which fees are 
being established; 
‘‘(B) the total percentage change for the 
previous fiscal year in basic pay under the Gen-
eral Schedule in accordance with section 5332 
of title 5, United States Code, as adjusted by 
any locality-based comparability payment pur-
suant to section 5304 of such title for Federal 
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employees stationed in the District of Columbia; 
or 
‘‘(C) the average annual change in the 
cost, per full-time equivalent position of the 
Food and Drug Administration, of all personnel 
compensation and benefits paid with respect to 
such positions for the first 5 years of the pre-
ceding 6 fiscal years. 
‘‘(3) COMPOUNDED
BASIS.—The adjustment 
made each fiscal year pursuant this subsection shall 
be added on a compounded basis to the sum of all 
adjustments made each fiscal year after fiscal year 
2010 under this subsection. 
‘‘(4) 
COLLECTIONS
AND
APPROPRIATIONS 
ACTS.— 
‘‘(A) IN
GENERAL.—The fees authorized 
by this section— 
‘‘(i) shall be retained in each fiscal 
year in an amount not to exceed the 
amount specified in appropriation Acts, or 
otherwise made available for obligation, for 
such fiscal year; and 
‘‘(ii) shall only be collected and avail-
able to cover the costs associated with reg-
istering importers, customs brokers, and 
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filers under section 801(r) and with ensur-
ing compliance with good importer prac-
tices respecting food. 
‘‘(B) LIMIT.—The total amount of fees 
charged, as adjusted under paragraphs (2) and 
(3), for a fiscal year may not exceed the total 
costs described in subparagraph (A)(ii) for such 
fiscal year.’’. 
(c) INSPECTION.—Section 704 (21 U.S.C. 374), as 
amended by sections 105, is amended by adding at the 
end the following: 
‘‘(i) IMPORTERS, BROKERS, AND FILERS.—Every 
person engaged in the importing, brokering for import, or 
filing for import of any food shall, upon request of an offi-
cer or employee designated by the Secretary, permit such 
officer or employee at all reasonable times to inspect the 
facilities of such person and have access to, and to copy 
and verify, any related records.’’. 
SEC. 206. UNIQUE IDENTIFICATION NUMBER FOR FOOD FA-
CILITIES, IMPORTERS, CUSTOM BROKERS, 
AND FILERS. 
Chapter IX (21 U.S.C. 391 et seq) is amended by 
adding at the end the following: 
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‘‘SEC. 911. UNIQUE FACILITY IDENTIFIER. 
‘‘(a) REGISTRATION OF FACILITY OR ESTABLISH-
MENT.—A person required to register a facility pursuant 
to section 415 shall submit, at the time of registration, 
a unique facility identifier for the facility or establishment. 
‘‘(b) REGISTRATION OF IMPORTERS, CUSTOM BRO-
KERS, AND FILERS.—A person required to register pursu-
ant to section 801(r) shall submit, at the time of registra-
tion, a unique facility identifier for the principal place of 
business for which such person is required to register 
under section 801(r). 
‘‘(c) GUIDANCE.—The Secretary may, by guidance, 
specify the unique numerical identifier system to be used 
to meet the requirements of subsections (a) and (b) and 
the form, manner, and timing of a submission under such 
subsections. In the absence of a specification by the Sec-
retary, a Dunn & Bradstreet Universal Numbering System 
(DUNS) number shall be used as the required numerical 
identifier for purposes of such subsections. 
‘‘(d) IMPORTATION.—An article of food imported or 
offered for import shall be refused admission unless the 
appropriate unique facility identifiers, as specified by the 
Secretary, are provided for such article.’’. 
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SEC. 207. PROHIBITION AGAINST DELAYING, LIMITING, OR 
REFUSING INSPECTION. 
(a) ADULTERATION.—Section 402 (21 U.S.C. 342), 
as amended by section 102(a), 103(a), and 104(a), is 
amended by adding at the end the following: 
‘‘(m) If it has been produced manufactured, proc-
essed, packed, or held in any farm, factory, warehouse, 
or establishment and the owner, operator, or agent of such 
farm, factory, warehouse, or establishment, or any agent 
of a governmental authority in the foreign country within 
which such farm, factory, warehouse, or establishment is 
located, delays or limits an inspection, or refuses to permit 
entry or inspection, under section 414 or 704.’’. 
(b) FOREIGN INSPECTIONS.—Section 704(a)(1) (21 
U.S.C. 374(a)(1)), as amended by section 106(c), is 
amended— 
(1) in the first sentence, by inserting ‘‘, includ-
ing any such food factory, warehouse, or establish-
ment whether foreign or domestic,’’ after ‘‘factory, 
warehouse, or establishment’’. 
(2) in the third sentence, by inserting ‘‘, includ-
ing any food factory, warehouse, establishment, or 
consulting laboratory whether foreign or domestic,’’ 
after ‘‘factory, warehouse, establishment, or con-
sulting laboratory’’. 
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SEC. 208. DEDICATED FOREIGN INSPECTORATE. 
Section 704 (21 U.S.C. 374), as amended by sections 
105 and 205, is amended by adding at the end the fol-
lowing: 
‘‘(j) DEDICATED
FOREIGN
INSPECTORATE.—The 
Secretary shall establish and maintain a corps of inspec-
tors dedicated to inspections of foreign food facilities. This 
corps shall be staffed and funded by the Secretary at a 
level sufficient to enable it to assist the Secretary in 
achieving the frequency of inspections for food facilities 
as described in this Act.’’. 
SEC. 209. PLAN AND REVIEW OF CONTINUED OPERATION 
OF FIELD LABORATORIES. 
(a) SUBMISSION OF PLAN.—Not later than 90 days 
before the Secretary terminates or consolidates any lab-
oratory, district office, or the functions (including the in-
spection and compliance functions) of any such laboratory 
or district office, specified in subsection (b), the Secretary 
shall submit a reorganization plan to the Comptroller Gen-
eral of the United States, the Committee on Energy and 
Commerce of the House of Representatives, and the Com-
mittee on Health, Education, Labor, and Pensions of the 
Senate. 
(b) SPECIFIED LABORATORIES AND OFFICES.—The 
laboratories and offices specified in this subsection are the 
following: 
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(1) Any of the 13 field laboratories responsible 
for analyzing food that were operated by the Office 
of Regulatory Affairs of the Food and Drug Admin-
istration as of January 1, 2007. 
(2) Any of the 20 district offices of the Food 
and Drug Administration with responsibility for food 
safety functioning as of January 1, 2007. 
(c) CONGRESSIONAL
REVIEW.—A reorganization 
plan described in subsection (a) is deemed to be a major 
rule (as defined in section 804(2) of title 5, United States 
Code) for purposes of chapter 8 of such title. 
SEC. 210. FALSE OR MISLEADING REPORTING TO FDA. 
(a) IN GENERAL.—Section 301(q)(2) (21 U.S.C. 
331(q)(2)) is amended by inserting after ‘‘device’’ the fol-
lowing: ‘‘or food’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply to submissions made on or after 
the date of the enactment of this Act. 
SEC. 211. SUBPOENA AUTHORITY. 
(a) PROHIBITED ACT.—Section 301(f) is amended by 
inserting before the period ‘‘or the failure or refusal to 
obey a subpoena issued pursuant to section 311’’. 
(b) AMENDMENT.—Chapter III (21 U.S.C. 331 et 
seq.) is amended by adding at the end the following: 
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100 
‘‘SEC. 311 EXERCISE OF SUBPOENA AUTHORITY. 
‘‘(a) IN GENERAL.—For the purpose of— 
‘‘(1) any hearing, investigation, or other pro-
ceeding respecting a violation of a provision of this 
Act relating to food; 
‘‘(2) any hearing, investigation, or other pro-
ceeding to determine if a person is in violation of a 
specific provision of this Act relating to food; or 
‘‘(3) any other matter relative to the Commis-
sioner’s jurisdiction over food under this Act, the 
Public Health Service Act, or the Federal Anti-Tam-
pering Act, 
the Commissioner may issue subpoenas requiring the at-
tendance and testimony of witnesses and the production 
of records and other things. 
‘‘(b) TIMING OF COMPLIANCE.—When the Commis-
sioner deems that immediate compliance with a subpoena 
issued under this section is necessary to address a threat 
of serious adverse health consequences or death, the sub-
poena may require immediate production. 
‘‘(c) SERVICE OF SUBPOENA.— 
‘‘(1) IN GENERAL.—Subpoenas of the Commis-
sioner shall be served by a person authorized by the 
Commissioner by delivering a copy thereof to the 
person named therein or by certified mail addressed 
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101 
to such person at such person’s last known dwelling 
place or principal place of business. 
‘‘(2) CORPORATIONS AND OTHER ENTITIES.— 
Service on a domestic or foreign corporation, part-
nership, unincorporated association, or other entity 
that is subject to suit under a common name may 
be made by delivering the subpoena to an officer, a 
managing or general agent, or any other agent au-
thorized by appointment or by law to receive service 
of process. 
‘‘(3) PERSON
OUTSIDE
U.S. JURISDICTION.— 
Service on any person not found within the terri-
torial jurisdiction of any court of the United States 
may be made in any manner as the Federal Rules 
of Civil Procedure prescribe for service in a foreign 
nation. 
‘‘(4) PROOF OF SERVICE.—A verified return by 
the person so serving the subpoena setting forth the 
manner of service, or, in the case of service by cer-
tified mail, the return post office receipt therefor 
signed by the person so served, shall be proof of 
service. 
‘‘(d) PAYMENT OF WITNESSES.—Witnesses subpoe-
naed under subsection (a) shall be paid the same fees and 
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102 
mileage as are paid witnesses in the district courts of the 
United States. 
‘‘(e) ENFORCEMENT.—In the case of a refusal to 
obey a subpoena duly served upon any person under sub-
section (a), any district court of the United States for the 
judicial district in which such person charged with refusal 
to obey is found, resides, or transacts business, upon ap-
plication by the Commissioner, shall have jurisdiction to 
issue an order compelling compliance with the subpoena 
and requiring such person to appear and give testimony 
or to appear and produce records and other things, or 
both. The failure to obey such order of the court may be 
punished by the court as contempt thereof. If the person 
charged with failure or refusal to obey is not found within 
the territorial jurisdiction of the United States, the United 
States District Court for the District of Columbia shall 
have the same jurisdiction, consistent with due process, 
to take any action respecting compliance with the sub-
poena by such person that such district court would have 
if such person were personally within the jurisdiction of 
such district court. 
‘‘(f) NONDISCLOSURE.—A United States district 
court for the district in which the subpoena is or will be 
served, upon application of the Commissioner, may issue 
an ex parte order that no person or entity disclose to any 
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103 
other person or entity (other than to an attorney to obtain 
legal advice) the existence of such subpoena for a period 
of up to 90 days. Such order may be issued on a showing 
that the records or things being sought may be relevant 
to the hearing, investigation, proceeding, or other matter 
and that there is reason to believe that such disclosure 
may result in— 
‘‘(1) furtherance of a potential violation under 
investigation; 
‘‘(2) endangerment to the life or physical safety 
of any person; 
‘‘(3) flight or other action to avoid prosecution 
or other enforcement remedies; 
‘‘(4) destruction of or tampering with evidence; 
or 
‘‘(5) intimidation of potential witnesses. 
An order under this subsection may be renewed for addi-
tional periods of up to 90 days upon a showing that any 
of the circumstances described in paragraphs (1) through 
(5) continue to exist. 
‘‘(g) RELATION TO OTHER PROVISIONS.—The sub-
poena authority vested in the Commissioner and the dis-
trict courts of the United States by this section is in addi-
tion to any such authority vested in the Commissioner or 
such courts by other provisions of law.’’. 
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104 
SEC. 212. WHISTLEBLOWER PROTECTIONS. 
Chapter IX (21 U.S.C. 391 et seq.), as amended by 
section 206, is amended by adding at the end the fol-
lowing: 
‘‘SEC. 912 PROTECTIONS FOR EMPLOYEES WHO REFUSE TO 
VIOLATE, OR WHO DISCLOSE VIOLATIONS OF, 
THIS ACT OR SECTION 351 OF THE PUBLIC 
HEALTH SERVICE ACT. 
‘‘(a) IN GENERAL.—No person who submits or is re-
quired under this Act or the Public Health Service Act 
to submit any information related to a food, or any officer, 
employee, contractor, subcontractor, or agent of such per-
son may discharge, demote, suspend, threaten, harass, or 
in any other manner discriminate against an employee in 
the terms and conditions of employment because of any 
lawful act done by the employee, including within the ordi-
nary course of the job duties of such employee— 
‘‘(1) to provide information, cause information 
to be provided, or otherwise assist in any investiga-
tion regarding any conduct which the employee rea-
sonably believes constitutes a violation of this Act, or 
any other provision of Federal law relating to the 
safety of a food, if the information or assistance is 
provided to, or an investigation stemming from the 
provided information is conducted by— 
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105 
‘‘(A) a Federal regulatory or law enforce-
ment agency; 
‘‘(B) any Member of Congress or any com-
mittee of Congress; or 
‘‘(C) a person with supervisory authority 
over the employee (or such other person work-
ing for the employer who has the authority to 
investigate, discover, or terminate the mis-
conduct); 
‘‘(2) to file, cause to be filed, testify, participate 
in, or otherwise assist in a proceeding filed, or about 
to be filed (with any knowledge of the employer), in 
any court or administrative forum relating to any 
such alleged violation; or 
‘‘(3) to refuse to commit or assist in any such 
violation. 
‘‘(b) ENFORCEMENT ACTION.— 
‘‘(1) IN GENERAL.—An employee who alleges 
discharge or other discrimination in violation of sub-
section (a) may seek relief in accordance with the 
provisions of subsection (c) by— 
‘‘(A) filing a complaint with the Secretary 
of Labor; or 
‘‘(B) if the Secretary of Labor has not 
issued a final decision within 210 days of the 
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