(i) may require that the food be la-
beled or marked as detained; and 
(ii) shall require that the food be re-
moved to a secure facility, if appropriate. 
(B) FOOD
SUBJECT
TO
AN
ORDER.—A 
food subject to a detention order under this 
subsection shall not be transferred by any per-
son from the place at which the food is re-
moved, until released by the Administrator or 
until the expiration of the detention period ap-
plicable under the order, whichever occurs first. 
(C) DELIVERY OF FOOD.—This subsection 
does not authorize the delivery of a food in ac-
cordance with execution of a bond while the ar-
ticle is subject to the order. 
(b) APPEAL OF DETENTION ORDER.— 
(1) IN GENERAL.—A person who would be enti-
tled to be a claimant for a food subject to a deten-
tion order under subsection (a) if the food were 
seized under section 304 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 334), may appeal the 
order to the Administrator. 
(2) ACTION
BY
THE
ADMINISTRATOR.—Not 
later than 5 days after an appeal is filed under para-
graph (1), the Administrator, after providing an op-
VerDate Nov 24 2008 
03:56 Feb 08, 2009
Jkt 079200
PO 00000
Frm 00088
Fmt 6652
Sfmt 6201
E:\BILLS\H875.IH
H875
smartinez on PROD1PC64 with BILLS
portunity for an informal hearing, shall confirm, 
modify, or terminate the order involved. 
(3) FINAL
AGENCY
ACTION.—Confirmation, 
modification, or termination by the Administrator 
under paragraph (2) shall be considered a final 
agency action for purposes of section 702 of title 5, 
United States Code. 
(4) TERMINATION.—A detention order under 
subsection (a) shall be considered to be terminated 
if, after 5 days, the Administrator has failed— 
(A) to provide an opportunity for an infor-
mal hearing; or 
(B) to confirm, modify, or terminate the 
order. 
(5) EFFECT OF INSTITUTING COURT ACTION.— 
If the Administrator initiates an action under sec-
tion 302 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 332) or section 304(a) of that Act 
(21 U.S.C. 334(a)) for a food subject to a detention 
order under subsection (a), the process for the ap-
peal of the detention order with respect to such food 
shall terminate. 
(c) CONDEMNATION OF FOOD.— 
VerDate Nov 24 2008 
03:56 Feb 08, 2009
Jkt 079200
PO 00000
Frm 00089
Fmt 6652
Sfmt 6201
E:\BILLS\H875.IH
H875
smartinez on PROD1PC64 with BILLS
(1) IN GENERAL.—After confirming a detention 
order, the Administrator may order the food con-
demned. 
(2) DESTRUCTION
OF
FOOD.—Any food con-
demned shall be destroyed under the supervision of 
the Administrator. 
(3) RELEASE OF FOOD.—If the Administrator 
determines that, through reprocessing, relabeling, or 
other action, a detained food can be brought into 
compliance with this Act, the food may be released 
following a determination by the Administrator that 
the relabeling or other action as specified by the Ad-
ministrator has been performed. 
(d) TEMPORARY HOLDS AT PORTS OF ENTRY.— 
(1) IN GENERAL.—If an officer or qualified em-
ployee of the Administration has reason to believe 
that a food is unsafe, is adulterated or misbranded, 
or otherwise fails to meet the requirements of this 
Act, and the officer or qualified employee is unable 
to inspect, examine, or investigate the food when the 
food is offered for import at a port of entry into the 
United States, the officer or qualified employee shall 
request the Secretary of Homeland Security to hold 
the food at the port of entry for a reasonable period 
of time, not to exceed 24 hours, to enable the Ad-
VerDate Nov 24 2008 
03:56 Feb 08, 2009
Jkt 079200
PO 00000
Frm 00090
Fmt 6652
Sfmt 6201
E:\BILLS\H875.IH
H875
smartinez on PROD1PC64 with BILLS
ministrator to inspect or investigate the food as ap-
propriate. 
(2) REMOVAL TO SECURE FACILITY.—The Ad-
ministrator shall work in coordination with the Sec-
retary of Homeland Security to remove a food held 
in accordance with paragraph (1) to a secure facility 
as appropriate. 
(3) PROHIBITION ON TRANSFER.—During the 
period in which food is held, the food shall not be 
transferred by any person from the port of entry 
into the United States, or from the secure facility to 
which the food has been removed. 
(4) 
DELIVERY
IN
ACCORDANCE
WITH
A 
BOND.—The delivery of the food in accordance with 
the execution of a bond while the food is held is not 
authorized. 
(5) PROHIBITION ON REEXPORT.—A food found 
unfit for human or animal consumption shall be pro-
hibited from reexport without further processing to 
remove the contamination and reinspection by the 
Administration. 
SEC. 403. NOTIFICATION AND RECALL. 
(a) NOTICE TO ADMINISTRATOR OF VIOLATION.— 
(1) IN GENERAL.—A person that has reason to 
believe that any food introduced into or in interstate 
VerDate Nov 24 2008 
03:56 Feb 08, 2009
Jkt 079200
PO 00000
Frm 00091
Fmt 6652
Sfmt 6201
E:\BILLS\H875.IH
H875
smartinez on PROD1PC64 with BILLS
commerce, or held for sale (whether or not the first 
sale) after shipment in interstate commerce, may be 
in violation of the food safety law shall immediately 
notify the Administrator of the identity and location 
of the food. 
(2) MANNER
OF
NOTIFICATION.—Notification 
under paragraph (1) shall be made in such manner 
and by such means as the Administrator may re-
quire by regulation. 
(b) RECALL AND CONSUMER NOTIFICATION.— 
(1) VOLUNTARY
ACTIONS.—If the Adminis-
trator determines that food is in violation of the food 
safety law when introduced into or while in inter-
state commerce or while held for sale (whether or 
not the first sale) after shipment in interstate com-
merce and that there is a reasonable probability that 
the food, if consumed, would present a threat to 
public health, as determined by the Administrator, 
the Administrator shall give the appropriate persons 
(including the manufacturers, importers, distribu-
tors, or retailers of the food) an opportunity to— 
(A) cease distribution of the food; 
(B) notify all persons— 
(i) processing, distributing, or other-
wise handling the food to immediately 
VerDate Nov 24 2008 
03:56 Feb 08, 2009
Jkt 079200
PO 00000
Frm 00092
Fmt 6652
Sfmt 6201
E:\BILLS\H875.IH
H875
smartinez on PROD1PC64 with BILLS
cease such activities with respect to the 
food; or 
(ii) to which the food has been distrib-
uted, transported, or sold, to immediately 
cease distribution of the food; 
(C) recall the food; 
(D) in conjunction with the Administrator, 
provide notice of the finding of the Adminis-
trator— 
(i) to consumers to whom the food 
was, or may have been, distributed; and 
(ii) to State and local public health of-
ficials; or 
(E) take any combination of the measures 
described in this paragraph, as determined by 
the Administrator to be appropriate in the cir-
cumstances. 
(2) MANDATORY
ACTIONS.—If a person re-
ferred to in paragraph (1) refuses to or does not 
adequately carry out the actions described in that 
paragraph within the time period and in the manner 
prescribed by the Administrator, the Administrator 
shall— 
(A) have authority to control and possess 
the food, including ordering the shipment of the 
VerDate Nov 24 2008 
03:56 Feb 08, 2009
Jkt 079200
PO 00000
Frm 00093
Fmt 6652
Sfmt 6201
E:\BILLS\H875.IH
H875
smartinez on PROD1PC64 with BILLS
(i) to consumers to whom the food 
was, or may have been, distributed; and 
(ii) to State and local public health of-
ficials; and 
(B) provide notice to the public of the 
names and addresses of retail locations at 
which recalled food products were available for 
sale. 
(4) NONDISTRIBUTION
BY
NOTIFIED
PER-
SONS.—A person that processes, distributes, or oth-
erwise handles the food, or to which the food has 
been distributed, transported, or sold, and that is 
notified under paragraph (1)(B) or (2)(B) shall im-
mediately cease distribution of the food. 
(5) AVAILABILITY
OF
RECORDS
TO
ADMINIS-
TRATOR.—Each person referred to in paragraph (1) 
that processed, distributed, or otherwise handled 
food shall make available to the Administrator infor-
mation necessary to carry out this subsection, as de-
termined by the Administrator, regarding— 
(A) persons that processed, distributed, or 
otherwise handled the food; and 
(B) persons to which the food has been 
transported, sold, distributed, or otherwise han-
dled. 
VerDate Nov 24 2008 
03:56 Feb 08, 2009
Jkt 079200
PO 00000
Frm 00095
Fmt 6652
Sfmt 6201
E:\BILLS\H875.IH
H875
smartinez on PROD1PC64 with BILLS
(c) INFORMAL HEARINGS ON ORDERS.— 
(1) IN GENERAL.—The Administrator shall pro-
vide any person subject to an order under subsection 
(b) with an opportunity for an informal hearing, to 
be held as soon as practicable but not later than 2 
business days after the issuance of the order. 
(2) SCOPE
OF
THE
HEARING.—In a hearing 
under paragraph (1), the Administrator shall con-
sider the actions required by the order and any rea-
sons why the food that is the subject of the order 
should not be recalled. 
(d) POST-HEARING RECALL ORDERS.— 
(1) AMENDMENT
OF
ORDER.—If, after pro-
viding an opportunity for an informal hearing under 
subsection (c), the Administrator determines that 
there is a reasonable probability that the food that 
is the subject of an order under subsection (b), if 
consumed, would present a threat to the public 
health, the Administrator, as the Administrator de-
termines to be necessary, may— 
(A) amend the order to require recall of 
the food or other appropriate action; 
(B) specify a timetable in which the recall 
shall occur; 
VerDate Nov 24 2008 
03:56 Feb 08, 2009
Jkt 079200
PO 00000
Frm 00096
Fmt 6652
Sfmt 6201
E:\BILLS\H875.IH
H875
smartinez on PROD1PC64 with BILLS
(C) require periodic reports to the Admin-
istrator describing the progress of the recall; 
and 
(D) provide notice of the recall to con-
sumers to whom the food was, or may have 
been, distributed. 
(2) VACATION OF ORDERS.—If, after providing 
an opportunity for an informal hearing under sub-
section (c), the Administrator determines that ade-
quate grounds do not exist to continue the actions 
required by the order, the Administrator shall vacate 
the order. 
(e) REMEDIES NOT EXCLUSIVE.—The remedies pro-
vided in this section shall be in addition to, and not exclu-
sive of, other remedies that may be available. 
SEC. 404. INJUNCTION PROCEEDINGS. 
(a) JURISDICTION.—The district courts of the United 
States, and the United States courts of the territories and 
possessions of the United States, shall have jurisdiction, 
for cause shown, to restrain a violation of section 202, 
203, 204, 208, or 401 (or a regulation promulgated there-
under). 
(b) TRIAL.—In a case in which violation of an injunc-
tion or restraining order issued under this section also 
VerDate Nov 24 2008 
03:56 Feb 08, 2009
Jkt 079200
PO 00000
Frm 00097
Fmt 6652
Sfmt 6201
E:\BILLS\H875.IH
H875
smartinez on PROD1PC64 with BILLS
constitutes a violation of the food safety law, trial shall 
be by the court or, upon demand of the accused, by a jury. 
SEC. 405. CIVIL AND CRIMINAL PENALTIES. 
(a) CIVIL SANCTIONS.— 
(1) CIVIL PENALTY.— 
(A) IN GENERAL.—Any person that com-
mits an act that violates the food safety law (in-
cluding a regulation promulgated or order 
issued under the food safety law) may be as-
sessed a civil penalty by the Administrator of 
not more than $1,000,000 for each such act. 
(B) SEPARATE
OFFENSE.—Each act de-
scribed in subparagraph (A) and each day dur-
ing which that act continues shall be considered 
a separate offense. 
(2) OTHER REQUIREMENTS.— 
(A) WRITTEN ORDER.—The civil penalty 
described in paragraph (1) shall be assessed by 
the Administrator by a written order, which 
shall specify the amount of the penalty and the 
basis for the penalty under subparagraph (B) 
considered by the Administrator. 
(B) AMOUNT
OF
PENALTY.—Subject to 
paragraph (1)(A), the amount of the civil pen-
VerDate Nov 24 2008 
03:56 Feb 08, 2009
Jkt 079200
PO 00000
Frm 00098
Fmt 6652
Sfmt 6201
E:\BILLS\H875.IH
H875
smartinez on PROD1PC64 with BILLS
alty shall be determined by the Administrator, 
after considering— 
(i) the gravity of the violation; 
(ii) the degree of culpability of the 
person; 
(iii) the size and type of the business 
of the person; and 
(iv) any history of prior offenses by 
the person under the food safety law. 
(C) REVIEW OF ORDER.—The order may 
be reviewed only in accordance with subsection 
(c). 
(b) CRIMINAL SANCTIONS.— 
(1) OFFENSE
RESULTING
IN
SERIOUS
ILL-
NESS.—Notwithstanding section 303(a) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
333(a)), if a violation of any provision of section 301 
of such Act (21 U.S.C. 301) with respect to an adul-
terated or misbranded food results in serious illness, 
the person committing the violation shall be impris-
oned for not more than 5 years, fined in accordance 
with title 18, United States Code, or both. 
(2) OFFENSE RESULTING IN DEATH.—Notwith-
standing section 303(a) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 333(a)), if a violation 
VerDate Nov 24 2008 
03:56 Feb 08, 2009
Jkt 079200
PO 00000
Frm 00099
Fmt 6652
Sfmt 6201
E:\BILLS\H875.IH
H875
smartinez on PROD1PC64 with BILLS