(3) develop efficient, rapid, and sensitive meth-
ods for determining and detecting the presence of con-
taminants in food products; 
(4) determine the sources of contamination of 
food and food products, including critical points of 
risk for fresh produce and other raw agricultural 
commodities; 
(5) develop consumption data with respect to 
food products; 
(6) draw upon research and educational pro-
grams that exist at the State and local level; 
(7) utilize the DNA matching system and other 
processes to identify and control pathogens; 
(8) address common and emerging zoonotic dis-
eases; 
(9) develop methods to reduce or destroy patho-
gens before, during, and after processing; 
(10) analyze the incidence of antibiotic resist-
ance as it pertains to the food supply and evaluate 
methods to reduce the transfer of antibiotic resistance 
to humans; and 
(11) conduct other research that supports the 
purposes of this Act. 
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Subtitle C—Response 
SEC. 131. PROCEDURES FOR SEIZURE. 
Section 304(b) (21 U.S.C. 334(b)) is amended by in-
serting ‘‘and except that, with respect to proceedings relat-
ing to food, Rule G of the Supplemental Rules of Admiralty 
or Maritime Claims and Asset Forfeiture Actions shall not 
apply in any such case, exigent circumstances shall be 
deemed to exist for all seizures brought under this section, 
and the summons and arrest warrant shall be issued by 
the clerk of the court without court review in any such case’’ 
after ‘‘in any such case shall be tried by jury’’. 
SEC. 132. ADMINISTRATIVE DETENTION. 
(a) AMENDMENTS.—Section 304(h) (21 U.S.C. 334(h)) 
is amended— 
(1) in paragraph (1)(A), by striking ‘‘credible 
evidence or information indicating’’ and inserting 
‘‘reason to believe’’; 
(2) in paragraph (1)(A), by striking ‘‘presents a 
threat of serious adverse health consequences or death 
to humans or animals’’ and inserting ‘‘is adulterated, 
misbranded, or otherwise in violation of this Act’’; 
(3) in paragraph (2), by striking ‘‘30’’ and in-
serting ‘‘60’’; 
(4) in paragraph (3), by striking the third sen-
tence; and 
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(5) in paragraph (4)(A) by striking the terms 
‘‘five’’ and ‘‘five-day’’ and inserting ‘‘fifteen’’ and 
‘‘fifteen-day’’, respectively. 
(b) REGULATIONS.—The Secretary shall issue regula-
tions or guidance to implement the amendments made by 
this section. 
(c) EFFECTIVE DATE.—The amendments made by this 
section shall take effect 180 days after the date of the enact-
ment of this Act. 
SEC. 133. QUARANTINE AUTHORITY FOR FOODS. 
(a) PROHIBITED ACT.—Section 301 (21 U.S.C. 331), 
as amended by sections 110 and 111, is amended by adding 
at the end by adding the following: 
‘‘(qq) The violation of a quarantine under section 
304(i).’’. 
(b) IN GENERAL.—Section 304 (21 U.S.C. 334) is 
amended by adding at the end the following: 
‘‘(i) QUARANTINE OF GEOGRAPHIC LOCATION.— 
‘‘(1) AUTHORITY TO QUARANTINE.—If the Sec-
retary determines that there is credible evidence or in-
formation that an article of food presents an immi-
nent threat of serious adverse health consequences or 
death to humans or animals, the Secretary may quar-
antine any geographic area within the United States 
where the Secretary reasonably believes such food is 
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located or from which such food originated. The au-
thority to quarantine includes prohibiting or restrict-
ing the movement of food or of any vehicle being used 
or that has been used to transport or hold such food 
within the geographic area. Any quarantine under 
this paragraph shall be no greater than is appro-
priate, as determined by the Secretary, to protect the 
public health. 
‘‘(2) NOTIFICATION
PROCEDURES.—Before any 
quarantine action is taken in any State under this 
subsection, the Secretary shall notify an appropriate 
official of the State affected and shall issue a public 
announcement of— 
‘‘(A) the Secretary’s findings that support 
the quarantine action; 
‘‘(B) the area affected by the intended quar-
antine action; 
‘‘(C) the reasons for the intended quar-
antine action; and 
‘‘(D) where practicable, an estimate of the 
anticipated duration of the quarantine. 
The Secretary is not required to make such announce-
ment by publication in the Federal Register, but may 
use a newspaper, radio or television, the Internet, or 
any reasonable means to make such announcement. 
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‘‘(3) NONDELEGATION.—The authority to quar-
antine under this subsection is limited to the Com-
missioner of Food and Drugs, the Principal Deputy 
Commissioner, and the Associate Commissioner for 
Regulatory Affairs of the Food and Drug Administra-
tion.’’. 
SEC. 134. CRIMINAL PENALTIES. 
Section 303(a) (21 U.S.C. 333) is amended— 
(1) in paragraph (1), by striking ‘‘Any’’ and in-
serting ‘‘Except as provided in paragraph (2) or (3), 
any’’; and 
(2) by adding at the end the following: 
‘‘(3) Notwithstanding paragraph (1), any person who 
knowingly violates paragraph (a), (b), (c), (k), or (v) of sec-
tion 301 with respect to any food that is misbranded or 
adulterated shall be imprisoned for not more than 10 years 
or fined in accordance with title 18, United States Code, 
or both.’’. 
SEC. 135. CIVIL PENALTIES FOR VIOLATIONS RELATING TO 
FOOD. 
(a) IN GENERAL.—Paragraph (2) of section 303(f) (21 
U.S.C. 331 et seq.) is amended to read as follows: 
‘‘(2)(A) Any person who violates a provision of section 
301 relating to food shall be subject to a civil penalty for 
each such violation of not more than— 
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‘‘(i) $20,000 in the case of an individual, not to 
exceed $50,000 in a single proceeding; and 
‘‘(ii) $250,000 in the case of any other person, 
not to exceed $1,000,000 in a single proceeding. 
‘‘(B) Any person who knowingly violates a provision 
of section 301 relating to food shall be subject to a civil 
penalty for each such violation of not more than— 
‘‘(i) $50,000 in the case of an individual, not to 
exceed $100,000 in a single proceeding; and 
‘‘(ii) $500,000 in the case of any other person, 
not to exceed $7,500,000 in a single proceeding. 
‘‘(C) Each violation described in subparagraph (A) or 
(B) and each day during which the violation continues shall 
be considered to be a separate offense.’’. 
(b) EFFECTIVE DATE.—The amendment made by sub-
section (a) applies to violations committed on or after the 
date of the enactment of this Act. 
SEC. 136. IMPROPER IMPORT ENTRY FILINGS. 
(a) PROHIBITED ACTS.—Section 301 (21 U.S.C. 331), 
as amended by sections 110, 111, and 133, is amended by 
adding at the end the following: 
‘‘(rr) The submission of information relating to food 
that is required by or under section 801 that is inaccurate 
or incomplete. 
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‘‘(ss) The failure to submit information relating to food 
that is required by or under section 801.’’. 
(b) DOCUMENTATION FOR IMPORTS.—Section 801 (21 
U.S.C. 381), as amended by section 109, is amended by 
adding at the end the following: 
‘‘(q) DOCUMENTATION.— 
‘‘(1) SUBMISSION.—The Secretary may require 
by regulation or guidance the submission of docu-
mentation or other information for articles of food 
that are imported or offered for import into the 
United States. 
‘‘(2) FORMAT.—A regulation or guidance under 
paragraph (1) may specify the format for submission 
of the documentation or other information.’’. 
TITLE II—MISCELLANEOUS 
SEC. 201. FOOD SUBSTANCES GENERALLY RECOGNIZED AS 
SAFE. 
Section 409 (21 U.S.C. 348) is amended by adding 
at the end the following: 
‘‘Substances Generally Recognized as Safe 
‘‘(k)(1) Not later than 60 days after the date of receipt 
by the Secretary, after the date of the enactment of this sub-
section, of a determination that a substance is a GRAS food 
substance, the Secretary shall post notice of such determina-
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tion and the supporting scientific justifications on the Food 
and Drug Administration’s public Web site. 
‘‘(2) Not later than 60 days after the date of receipt 
of a request under paragraph (1), the Secretary shall ac-
knowledge receipt of such request by informing the requester 
in writing of the date on which the request was received. 
‘‘(3) In this subsection, the term ‘GRAS food substance’ 
means a substance excluded from the definition of the term 
‘food additive’ in section 201(s) because such substance is 
generally recognized, among experts qualified by scientific 
training and experience to evaluate its safety, as having 
been adequately shown through scientific procedures (or, in 
the case of a substance used in food prior to January 1, 
1958, through either scientific procedures or experience 
based on common use in food) to be safe under the condi-
tions of its intended use.’’. 
SEC. 202. COUNTRY OF ORIGIN LABELING; DISCLOSURE OF 
SOURCE OF INGREDIENTS. 
(a) MISBRANDING.—Section 403 (21 U.S.C. 343), as 
amended by sections 101(a), 109(a), and 114(a), is amend-
ed by adding at the end the following: 
‘‘(cc) In the case of a processed food, if the labeling 
of the food fails to identify the country in which the final 
processing of the food occurs. 
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‘‘(dd) In the case of nonprocessed food, if the labeling 
of the food fails to identify the country of origin of the 
food.’’. 
(b) REGULATIONS.— 
(1) PROMULGATION.—Not later than 180 days 
after the date of the enactment of this Act, the Sec-
retary of Health and Human Services shall promul-
gate final regulations to carry out paragraphs (cc) 
and (dd) of section 403 of the Federal Food, Drug, 
and Cosmetic Act, as added by subsection (a). 
(2) RELATION TO OTHER REQUIREMENTS.—Reg-
ulations promulgated under paragraph (1) shall pro-
vide that labeling meets the requirements of para-
graphs (cc) and (dd) of section 403 of the Federal 
Food, Drug, and Cosmetic Act, as added by subsection 
(a), if— 
(A) in the case of a processed food, the label 
of the food informs the consumer of the country 
where the final processing of the food occurred in 
accordance with labeling requirements of the 
United States Customs and Border Protection; or 
(B) in the case of a nonprocessed food, the 
label of the food informs the consumer of the 
country of origin of the food in accordance with 
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labeling requirements of the Department of Agri-
culture. 
(c) EFFECTIVE DATE.—The requirements of para-
graphs (cc) and (dd) of section 403 of the Federal Food, 
Drug, and Cosmetic Act, as added by subsection (a), take 
effect on the date that is 2 years after the date of the enact-
ment of this Act. 
SEC. 203. EXPORTATION CERTIFICATE PROGRAM. 
Section 801(e)(4) (21 U.S.C. 381) is amended— 
(1) in the matter preceding clause (i) in sub-
paragraph (A)— 
(A) by inserting ‘‘from the United States’’ 
after ‘‘exports’’; and 
(B) by striking ‘‘a drug, animal drug, or 
device’’ and inserting ‘‘a food (including animal 
feed), drug, animal drug, or device’’; 
(2) in subparagraph (A)(i)— 
(A) by striking ‘‘in writing’’; and 
(B) by striking ‘‘exported drug, animal 
drug, or device’’ and inserting ‘‘exported food, 
drug, animal drug, or device’’; 
(3) in subparagraph (A)(ii)— 
(A) by striking ‘‘in writing’’; 
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(B) by striking ‘‘the drug, animal drug, or 
device’’ and inserting ‘‘the food, drug, animal 
drug, or device’’; and 
(C) by striking ‘‘the drug or device’’ and in-
serting ‘‘the food, drug, or device’’; 
(4) by redesignating subparagraph (B) as sub-
paragraph (C); 
(5) by inserting after subparagraph (A) the fol-
lowing: 
‘‘(B) For purposes of this paragraph, a certification 
by the Secretary shall be made on such basis and in such 
form (such as a publicly available listing) as the Secretary 
determines appropriate.’’; and 
(6) by adding at the end the following: 
‘‘(D) Notwithstanding subparagraph (C), if the Sec-
retary issues an export certification within the 20 days pre-
scribed by subparagraph (A) with respect to the export of 
food, a fee for such certification shall not exceed such 
amount as the Secretary determines is reasonably related 
to the cost of issuing certificates under subparagraph (A) 
with respect to the export of food. The Secretary may adjust 
this fee annually to account for inflation and other cost ad-
justments. Fees collected for a fiscal year pursuant to this 
subparagraph shall be credited to the appropriation account 
for salaries and expenses of the Food and Drug Administra-
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tion and shall be available in accordance with appropria-
tions Acts until expended, without fiscal year limitation. 
Such fees shall be collected in each fiscal year in an amount 
equal to the amount specified in appropriations Acts for 
such fiscal year and shall only be collected and available 
for the costs of the Food and Drug Administration to cover 
the cost of issuing such certifications. Such sums as nec-
essary may be transferred from such appropriation account 
for salaries and expenses of the Food and Drug Administra-
tion without fiscal year limitation to such appropriation 
account for salaries and expenses with fiscal year limita-
tion.’’. 
SEC. 204. REGISTRATION FOR COMMERCIAL IMPORTERS OF 
FOOD; FEE. 
(a) REGISTRATION.— 
(1) PROHIBITIONS.—Section 301 (21 U.S.C. 
331), as amended by sections 110, 111, 133, and 136, 
is amended by adding at the end the following: 
‘‘(tt) The failure to register in accordance with section 
801(r).’’. 
(2) MISBRANDING.—Section 403 (21 U.S.C. 343) 
as amended by sections 101(a), 109(a), 114(a), and 
202(a), is amended by adding at the end the fol-
lowing: 
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‘‘(ee) If it is imported or offered for import by an im-
porter 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.— 
‘‘(1) REGISTRATION.—The Secretary shall re-
quire an importer 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. 
‘‘(2) GOOD IMPORTER PRACTICES.—The mainte-
nance of registration under this subsection is condi-
tioned on compliance with good importer practices. 
Good importer practices shall include the verification 
of good manufacturing practices and preventive con-
trols of the importer’s foreign suppliers, as applicable. 
‘‘(3) SUSPENSION OF REGISTRATION.— 
‘‘(A) IN GENERAL.—Registration under this 
subsection is subject to suspension upon a find-
ing by the Secretary, after notice and an oppor-
tunity for an informal hearing, of— 
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‘‘(i) a violation of this Act; or 
‘‘(ii) the knowing or repeated making 
of an inaccurate or incomplete statement or 
submission of information relating to the 
importation of food. 
‘‘(B) REQUEST.—The importer whose reg-
istration is suspended may request that the Sec-
retary vacate the suspension of registration when 
such importer has corrected the violation that is 
the basis for such suspension. 
‘‘(C) VACATING
OF
SUSPENSION.—If the 
Secretary determines that adequate reasons do 
not exist to continue the suspension of a registra-
tion, the Secretary shall vacate such suspension. 
‘‘(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 in-
formation. 
‘‘(B) NOTICE OF CANCELLATION.—Cancella-
tion shall be preceded by notice to the importer 
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of the intent to cancel the registration and the 
basis for such cancellation. 
‘‘(C) TIMELY UPDATE OR CORRECTION.—If 
the registration for the importer is updated or 
corrected no later than 7 days after notice is pro-
vided under subparagraph (B), the Secretary 
shall not cancel such registration. 
‘‘(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) of the Federal Food, Drug, and Cosmetic Act, 
as added by paragraph (3). 
(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. 
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110 
(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 col-
lect an annual fee for the registration of an importer of 
food under section 801(r). 
‘‘(b) AMOUNT OF FEE.— 
‘‘(1) BASE AMOUNTS.—The registration fee under 
subsection (a) shall be— 
‘‘(A) for fiscal year 2010, $500; and 
‘‘(B) for fiscal year 2011 and each subse-
quent fiscal year, the fee for fiscal year 2010 as 
adjusted under paragraph (2). 
‘‘(2) ADJUSTMENT.—For fiscal year 2011 and 
subsequent fiscal years, the fees established pursuant 
to paragraph (1) shall be adjusted by the Secretary 
by notice, published in the Federal Register, for a fis-
cal 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 
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30 preceding the fiscal year for which fees are 
being established; 
‘‘(B) the total percentage change for the pre-
vious fiscal year in basic pay under the General 
Schedule in accordance with section 5332 of title 
5, United States Code, as adjusted by any local-
ity-based comparability payment pursuant to 
section 5304 of such title for Federal 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 compensa-
tion and benefits paid with respect to such posi-
tions for the first 5 years of the preceding 6 fis-
cal 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 ad-
justments made each fiscal year after fiscal year 2010 
under this subsection. 
‘‘(4) WAIVER FOR IMPORTERS REQUIRED TO PAY 
REGISTRATION FEE.—In the case of a person who is 
required to pay both a fee under section 743 for reg-
istration of one or more facilities under section 415 
and a fee under this section for registration as an im-
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porter of food under section 801(r), the Secretary 
shall waive the fees applicable to such person under 
section 743 or the fee applicable to such person under 
this section. 
‘‘(c) CREDITING AND AVAILABILITY OF FEES.— 
‘‘(1) IN GENERAL.—Fees authorized under sub-
section (a) shall be collected and available for obliga-
tion only to the extent and in the amount provided 
in advance in appropriations Acts. Such fees are au-
thorized to remain available until expended. Such 
sums as may be necessary may be transferred from 
the Food and Drug Administration salaries and ex-
penses appropriation account without fiscal year lim-
itation to such appropriation account for salaries and 
expenses with such fiscal year limitation. 
‘‘(2) 
COLLECTIONS
AND
APPROPRIATIONS 
ACTS.—The fees authorized by this section— 
‘‘(A) 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 
‘‘(B) shall only be collected and available to 
cover the costs associated with registering im-
porters under section 801(r) and with ensuring 
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compliance with good importer practices respect-
ing food. 
‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For 
each of fiscal years 2010 through 2014, there are au-
thorized to be appropriated for fees under this section 
such sums as may be necessary.’’. 
(c) INSPECTION.—Section 704 (21 U.S.C. 374), as 
amended by section 105, is amended by adding at the end 
the following: 
‘‘(i) IMPORTERS.—Every person engaged in the im-
porting of any food shall, upon request of an officer or em-
ployee 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. 205. REGISTRATION FOR CUSTOMS BROKERS AND FIL-
ERS; FEE. 
(a) REGISTRATION.— 
(1) PROHIBITIONS.—Section 301(tt) (21 U.S.C. 
331), as added by section 204, is amended by insert-
ing ‘‘or 801(s)’’ after ‘‘801(r)’’. 
(2) MISBRANDING.—Section 403(ee) (21 U.S.C. 
343), as added by section 204, is amended— 
(A) by inserting ‘‘or a customs broker or 
filer’’ after ‘‘by an importer’’; and 
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(B) by inserting ‘‘or 801(s)’’ after ‘‘801(r)’’. 
(3) REGISTRATION.—Section 801, as amended by 
sections 109, 136, and 204, is amended by adding at 
the end the following: 
‘‘(s) REGISTRATION OF CUSTOMS BROKERS AND FIL-
ERS.— 
‘‘(1) REGISTRATION.—The Secretary shall re-
quire a customs broker or filer, with respect to the im-
portation 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. 
‘‘(2) SUSPENSION OF REGISTRATION.— 
‘‘(A) IN GENERAL.—Registration under this 
subsection is subject to suspension upon a find-
ing by the Secretary, after notice and an oppor-
tunity for an informal hearing, of— 
‘‘(i) a violation of this Act; or 
‘‘(ii) the knowing or repeated making 
of an inaccurate or incomplete statement or 
submission of information relating to the 
importation of food. 
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‘‘(B) REQUEST.—The customs broker or 
filer whose registration is suspended may request 
that the Secretary vacate the suspension of reg-
istration when such customs broker or filer has 
corrected the violation that is the basis for such 
suspension. 
‘‘(C) VACATING
OF
SUSPENSION.—If the 
Secretary determines that adequate reasons do 
not exist to continue the suspension of a registra-
tion, the Secretary shall vacate such suspension. 
‘‘(3) 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 in-
formation. 
‘‘(B) NOTICE OF CANCELLATION.—Cancella-
tion shall be preceded by notice to the customs 
broker or filer of the intent to cancel the registra-
tion and the basis for such cancellation. 
‘‘(C) TIMELY UPDATE OR CORRECTION.—If 
the registration for the customs broker or filer is 
updated or corrected no later than 7 days after 
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notice is provided under subparagraph (B), the 
Secretary shall not cancel such registration. 
‘‘(4) 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(s) of the Federal Food, Drug, and Cosmetic Act, 
as added by paragraph (3). 
(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) INSPECTION.—Section 704 (21 U.S.C. 374), as 
amended by sections 105 and 204, is amended by adding 
at the end the following: 
‘‘(j) BROKERS AND FILERS.—Every person engaged in 
the brokering for import or filing for import of any food 
shall, upon request of an officer or employee designated by 
the Secretary, permit such officer or employee at all reason-
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able 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 add-
ing at the end the following: 
‘‘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) or 801(s) shall submit, at the time 
of registration, a unique facility identifier for the principal 
place of business for which such person is required to reg-
ister under section 801(r) or 801(s). 
‘‘(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 sub-
sections. 
‘‘(d) IMPORTATION.—An article of food imported or of-
fered for import shall be refused admission unless the appro-
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priate unique facility identifiers, as specified by the Sec-
retary, are provided for such article.’’. 
SEC. 207. PROHIBITION AGAINST DELAYING, LIMITING, OR 
REFUSING INSPECTION. 
(a) ADULTERATION.—Section 402 (21 U.S.C. 342), as 
amended by sections 102, 103(a), and 104(a), is amended 
by adding at the end the following: 
‘‘(n) If it has been produced, manufactured, processed, 
packed, or held in any farm, factory, warehouse, or estab-
lishment and the owner, operator, or agent of such farm, 
factory, warehouse, or establishment, or any agent of a gov-
ernmental 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 amend-
ed— 
(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’’; and 
(2) in the third sentence, by inserting ‘‘, includ-
ing any food factory, warehouse, establishment, or 
consulting laboratory whether foreign or domestic,’’ 
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after ‘‘factory, warehouse, establishment, or consulting 
laboratory’’. 
SEC. 208. DEDICATED FOREIGN INSPECTORATE. 
Section 704 (21 U.S.C. 374), as amended by sections 
105, 204, and 205, is amended by adding at the end the 
following: 
‘‘(k) DEDICATED FOREIGN INSPECTORATE.—The Sec-
retary shall establish and maintain a corps of inspectors 
dedicated to inspections of foreign food facilities. This corps 
shall be staffed and funded by the Secretary at a level suffi-
cient 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 be-
fore the Secretary terminates or consolidates any labora-
tory, district office, or the functions (including the inspec-
tion and compliance functions) of any such laboratory or 
district office, specified in subsection (b), the Secretary shall 
submit a reorganization plan to the Comptroller General 
of the United States, the Committee on Energy and Com-
merce of the House of Representatives, and the Committee 
on Health, Education, Labor, and Pensions of the Senate. 
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(b) SPECIFIED LABORATORIES
AND OFFICES.—The 
laboratories and offices specified in this subsection are the 
following: 
(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 Administra-
tion 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 sub-
section (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 the following: ‘‘or the failure or 
refusal to obey a subpoena issued pursuant to section 311’’. 
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(b) AMENDMENT.—Chapter III (21 U.S.C. 331 et seq.) 
is amended by adding at the end the following: 
‘‘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, the Public Health Service Act, or the Federal 
Anti-Tampering Act, relating to food; or 
‘‘(2) any hearing, investigation, or other pro-
ceeding to determine if a person is in violation of a 
specific provision of this Act, the Public Health Serv-
ice Act, or the Federal Anti-Tampering Act, relating 
to food, 
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 per-
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son named therein or by certified mail addressed 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, partner-
ship, 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 authorized by 
appointment or by law to receive service of process. 
‘‘(3) PERSON
OUTSIDE
U.S. JURISDICTION.— 
Service on any person not found within the territorial 
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 serv-
ice. 
‘‘(d) PAYMENT OF WITNESSES.—Witnesses subpoenaed 
under subsection (a) shall be paid the same fees and mileage 
as are paid witnesses in the district courts of the United 
States. 
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‘‘(e) ENFORCEMENT.—In the case of a refusal to obey 
a subpoena duly served upon any person under subsection 
(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 application 
by the Commissioner, shall have jurisdiction to issue an 
order compelling compliance with the subpoena and requir-
ing 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 jurisdic-
tion of the United States, the United States District Court 
for the District of Columbia shall have the same jurisdic-
tion, consistent with due process, to take any action respect-
ing compliance with the subpoena 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 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 
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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 district 
courts of the United States by this section is in addition 
to any such authority vested in the Commissioner or such 
courts by other provisions of law. 
‘‘(h) NONDELEGATION.—The authority to issue a sub-
poena under this section is limited to the Secretary or an 
official designated by the Secretary. An official may not 
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be so designated unless the official is the director of the dis-
trict under this Act in which the article involved is located, 
or is an official senior to such director.’’. 
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 following: 
‘‘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 person 
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 ordinary 
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 
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provided to, or an investigation stemming from the 
provided information is conducted by— 
‘‘(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 working 
for the employer who has the authority to inves-
tigate, discover, or terminate the misconduct); 
‘‘(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 dis-
charge or other discrimination in violation of sub-
section (a) may seek relief in accordance with the pro-
visions of subsection (c) by— 
‘‘(A) filing a complaint with the Secretary 
of Labor; or 
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‘‘(B) if the Secretary of Labor has not 
issued a final decision within 210 days of the fil-
ing of the complaint and there is no showing 
that such delay is due to the bad faith of the 
claimant, or within 90 days after receiving a 
final decision or order from the Secretary, bring-
ing an action at law or equity for de novo re-
view in the appropriate district court of the 
United States, which court shall have jurisdic-
tion over such action without regard to the 
amount in controversy, and which action shall, 
at the request of either party to such action, be 
tried by the court with a jury. 
‘‘(2) PROCEDURE.— 
‘‘(A) IN
GENERAL.—Any action under 
paragraph (1) shall be governed under the rules 
and procedures set forth in section 42121(b) of 
title 49, United States Code. 
‘‘(B) EXCEPTION.—Notification in an ac-
tion under paragraph (1) shall be made in ac-
cordance with section 42121(b)(1) of title 49, 
United States Code, except that such notification 
shall be made to the person named in the com-
plaint and to the employer. 
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‘‘(C) BURDENS
OF
PROOF.—An action 
brought under paragraph (1)(B) shall be gov-
erned by the legal burdens of proof set forth in 
section 42121(b) of title 49, United States Code. 
‘‘(D) STATUTE OF LIMITATIONS.—An action 
under paragraph (1) shall be commenced not 
later than 180 days after the date on which the 
violation occurs. 
‘‘(c) REMEDIES.— 
‘‘(1) IN GENERAL.—An employee prevailing in 
any action under subsection (b)(1) shall be entitled to 
all relief necessary to make the employee whole. 
‘‘(2) ISSUANCE OF ORDER.—If, in response to a 
complaint filed under subsection (b)(1), the Secretary 
of Labor or the district court, as applicable, deter-
mines that a violation of subsection (a) has occurred, 
the Secretary or the court shall order the person who 
committed such violation— 
‘‘(A) to take affirmative action to abate the 
violation; 
‘‘(B) to— 
‘‘(i) reinstate the complainant to his or 
her former position together with compensa-
tion (including backpay); and 
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