123 
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 of-
fense.’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (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: 
‘‘(xx) The submission of information relating to food 
that is required by or under section 801 that is inaccurate 
or incomplete. 
‘‘(yy) The failure to submit information relating to 
food that is required by or under section 801.’’.
124 
(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: 
‘‘(r) 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. When developing any regulation or 
guidance in accordance with this paragraph, to the 
extent that the collection of documentation or other 
information involves Customs and Border Protection 
efforts or resources, the Secretary shall consult with 
Customs and Border Protection. 
‘‘(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 re-
ceipt by the Secretary, after the date of the enactment
125 
of this subsection, of a determination that a substance is 
a GRAS food substance, the Secretary shall post notice 
of such determination and the supporting scientific jus-
tifications 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 re-
quester in writing of the date on which the request was 
received. 
‘‘(3) In this subsection, the term ‘GRAS food sub-
stance’ 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 proce-
dures (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 conditions of its intended use.’’. 
SEC. 202. COUNTRY OF ORIGIN LABELING. 
(a) MISBRANDING.—Section 403 (21 U.S.C. 343), as 
amended by sections 101(a), 109(a), and 114(a), is 
amended by adding at the end the following:
126 
‘‘(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. 
‘‘(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.— 
Regulations promulgated under paragraph (1) shall 
provide that labeling meets the requirements of 
paragraphs (cc) and (dd) of section 403 of the Fed-
eral 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 country of origin 
marking requirements of the United States 
Customs and Border Protection; or
127 
(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 
labeling requirements of the Department of Ag-
riculture. 
(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 
enactment 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)—
128 
(A) by striking ‘‘in writing’’; 
(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 
inserting ‘‘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 
prescribed 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 ad-
just this fee annually to account for inflation and other 
cost adjustments. Fees collected for a fiscal year pursuant
130 
and 202, is amended by adding at the end the fol-
lowing: 
‘‘(ee) If it is imported or offered for import by an 
importer not duly registered under section 801(s).’’. 
(3) REGISTRATION.—Section 801, as amended 
by sections 109 and 136, is amended by adding at 
the end the following: 
‘‘(s) 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 1011, to sub-
mit appropriate unique facility identifiers as a 
condition of registration. 
‘‘(2) GOOD IMPORTER PRACTICES.—The main-
tenance of registration under this subsection is con-
ditioned on compliance with good importer practices 
in accordance with the following: 
‘‘(A) The Secretary, in consultation with 
Customs and Border Protection, shall promul-
gate regulations to establish good importer 
practices that specify the measures an importer
131 
shall take to ensure imported food is in compli-
ance with the requirements of this Act. 
‘‘(B) The measures under subparagraph 
(A) shall ensure that the importer of a food— 
‘‘(i) has adequate information about 
the food, its hazards, and the requirements 
of this Act applicable to such food; 
‘‘(ii) has adequate information or pro-
cedures in place to verify that both the 
food and each person that produced, man-
ufactured, processed, packed, transported, 
or held the food, including components of 
the food, are in compliance with the re-
quirements of this Act; and 
‘‘(iii) has adequate procedures in 
place to take corrective action, such as the 
ability to appropriately trace, withhold, 
and recall articles of food, if a food im-
ported by the importer is not in compliance 
with the requirements of this Act. 
‘‘(C) In promulgating good importer prac-
tices regulations, the Secretary may, as appro-
priate— 
‘‘(i) incorporate certification of com-
pliance under section 801(q) and participa-
132 
tion in the safe and secure food importa-
tion program under section 805; and 
‘‘(ii) take into account differences 
among importers and the types of imports, 
including based on the level of risk posed 
by the imported food. 
‘‘(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 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 
Secretary 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 reg-
133 
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 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 provided under subparagraph (B), the Sec-
retary 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
134 
‘‘(B) may establish other exemptions from 
the requirements of this subsection.’’. 
(4) REGULATIONS.—Not later than 36 months 
after the date of the enactment of this Act, the Sec-
retary of Health and Human Services in consulta-
tion with the Commissioner responsible for Customs 
and Border Protection shall promulgate the regula-
tions required to carry out section 801(s) of the 
Federal Food, Drug, and Cosmetic Act, as added by 
paragraph (3). In establishing the effective date of 
a regulation promulgated under section 801(s), the 
Secretary shall, in consultation with the Commis-
sioner responsible for Customs and Border Protec-
tion, as appropriate, provide a reasonable period of 
time for importers of food to comply with good im-
porter practices, taking into account differences 
among importers and the types of imports, including 
based on the level of risk posed by the imported 
food. 
(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:
135 
‘‘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(s). 
‘‘(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 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