the article that is the subject of an order under sub-
section (b) presents a threat to public health, the 
Secretary may, as the Secretary determines to be 
necessary— 
‘‘(A) amend the order under subsection 
(b)— 
‘‘(i) to require recall of the article or 
other appropriate action; and 
‘‘(ii) to specify a timetable during 
which the recall shall occur; 
‘‘(B) require periodic reports to the Sec-
retary describing the progress of the recall; or 
‘‘(C) provide notice of the recall to con-
sumers to which the article was, or may have 
been, distributed. 
‘‘(2) VACATION OF ORDERS.—If, after providing 
an opportunity for an informal hearing under sub-
section (c), the Secretary determines that adequate 
grounds do not exist to continue the actions required 
by the order, the Secretary shall vacate the order. 
‘‘(e) REMEDIES NOT EXCLUSIVE.—The remedies au-
thorized by this section shall be in addition to any other 
remedies that may be available. 
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‘‘SEC. 32. REFUSAL OR WITHDRAWAL OF INSPECTION OF 
ESTABLISHMENTS. 
‘‘(a) IN GENERAL.—The Secretary may, for such pe-
riod, or indefinitely, as the Secretary considers necessary 
to carry out this Act, refuse to provide or withdraw inspec-
tion under this Act with respect to an establishment if the 
Secretary determines, after opportunity for a hearing on 
the record is provided to the applicant for, or recipient 
of, inspection, that the applicant or recipient, or any per-
son responsibly connected with the applicant or recipient 
(within the meaning of section 18(a)), has committed a 
willful violation or repeated violations of this Act (includ-
ing a regulation promulgated under this Act). 
‘‘(b) DENIAL OR SUSPENSION OF INSPECTION PEND-
ING HEARING.—The Secretary may deny or suspend in-
spection under this Act, pending opportunity for an expe-
dited hearing, with respect to an action under subsection 
(a), if the Secretary determines that the denial or suspen-
sion is in the public interest to protect the health or wel-
fare of consumers or to ensure the effective performance 
of an official duty under this Act. 
‘‘(c) JUDICIAL REVIEW.— 
‘‘(1) IN GENERAL.—A determination and order 
of the Secretary with respect to the refusal or with-
drawal of inspection under this section shall be final 
unless, not later than 30 days after the effective 
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date of the order, the affected applicant for, or re-
cipient of, inspection— 
‘‘(A) files a petition for judicial review of 
the order; and 
‘‘(B) simultaneously sends a copy of the 
petition by certified mail to the Secretary. 
‘‘(2) REFUSAL
OR
WITHDRAWAL
OF
INSPEC-
TION PENDING REVIEW.—Inspection shall be refused 
or withdrawn as of the effective date of the order 
pending any judicial review of the order unless the 
Secretary directs otherwise. 
‘‘(3) VENUE; RECORD.—Judicial review of the 
order shall be— 
‘‘(A) in— 
‘‘(i) the United States court of ap-
peals for the circuit in which the applicant 
for, or recipient of, inspection resides or 
has its principal place of business; or 
‘‘(ii) the United States Court of Ap-
peals for the District of Columbia Circuit; 
and 
‘‘(B) on the record on which the deter-
mination and order are based. 
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‘‘(d) REMEDIES NOT EXCLUSIVE.—The remedies au-
thorized by this section shall be in addition to any other 
remedies that may be available. 
‘‘SEC. 33. CIVIL PENALTIES. 
‘‘(a) IN GENERAL.— 
‘‘(1) ASSESSMENT.—The Secretary may assess 
against a person that violates this Act (including a 
regulation promulgated or order issued under this 
Act) a civil penalty for each violation of not more 
than $100,000. 
‘‘(2) SEPARATE
OFFENSES.—Each violation 
and each day during which the violation continues 
shall be considered to be a separate offense. 
‘‘(3) NOTICE
AND
OPPORTUNITY
FOR
HEAR-
ING.—The Secretary shall not assess a civil penalty 
under this section against a person unless the person 
is given notice and opportunity for a hearing on the 
record before the Secretary in accordance with sec-
tions 554 and 556 of title 5, United States Code. 
‘‘(4) DETERMINATION
OF
CIVIL
PENALTY 
AMOUNT.—The amount of a civil penalty under this 
section— 
‘‘(A) shall be assessed by the Secretary by 
written order, taking into account— 
‘‘(i) the gravity of the violation; 
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‘‘(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 this Act; and 
‘‘(B) shall be reviewed only in accordance 
with subsection (b). 
‘‘(b) JUDICIAL REVIEW.— 
‘‘(1) IN GENERAL.—An order assessing a civil 
penalty against a person under subsection (a) shall 
be final unless the person— 
‘‘(A) not later than 30 days after the effec-
tive date of the order, files a petition for judi-
cial review of the order in— 
‘‘(i) the United States court of ap-
peals for the circuit in which the person re-
sides or has its principal place of business; 
or 
‘‘(ii) the United States Court of Ap-
peals for the District of Columbia Circuit; 
and 
‘‘(B) simultaneously sends a copy of the 
petition by certified mail to the Secretary. 
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‘‘(2) FILING OF COPY OF RECORD.—The Sec-
retary shall promptly file in the court a certified 
copy of the record on which the order was issued. 
‘‘(c) COLLECTION ACTIONS FOR FAILURE TO PAY 
ASSESSMENT.— 
‘‘(1) REFERRAL TO ATTORNEY GENERAL.—If a 
person fails to pay a civil penalty assessed under 
subsection (a) after the order assessing the civil pen-
alty has become a final order, or after the court of 
appeals has entered final judgment in favor of the 
Secretary, the Secretary shall refer the matter to the 
Attorney General. 
‘‘(2) ACTION
BY
ATTORNEY
GENERAL.—The 
Attorney General shall bring a civil action to recover 
the amount of the civil penalty in United States dis-
trict court. 
‘‘(3) SCOPE
OF
REVIEW.—In a civil action 
under paragraph (2), the validity and appropriate-
ness of the order of the Secretary assessing the civil 
penalty shall not be subject to review. 
‘‘(d) REFUSAL
OR WITHDRAWAL
OF INSPECTION 
PENDING PAYMENT.—If a person fails to pay the amount 
of a civil penalty after the order assessing the civil penalty 
has become a final order, the Secretary may refuse to pro-
vide or withdraw inspection under this Act of the person 
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until the civil penalty is paid or until the Secretary directs 
otherwise. 
‘‘(e) PENALTIES IN LIEU OF OTHER ACTIONS.— 
Nothing in this Act requires the Secretary to report for 
prosecution, or for the commencement of an action, any 
violation of this Act in any case in which the Secretary 
believes that the public interest will be adequately served 
by the assessment of a civil penalty under this section. 
‘‘(f) REMEDIES NOT EXCLUSIVE.—The remedies au-
thorized by this section shall be in addition to any other 
remedies that may be available.’’. 
SEC. 4. NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED ARTI-
CLES OF FOOD. 
(a) PROHIBITED ACTS.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend-
ed by adding at the end the following: 
‘‘(ii)(1) The failure to notify the Secretary in viola-
tion of section 311(a). 
‘‘(2) The failure to comply with— 
‘‘(A) an order issued under section 311(b) 
following any hearing requested under section 
311(c); or 
‘‘(B) an amended order issued under sec-
tion 311(d)(1).’’. 
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(b) NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED ARTICLES OF FOOD; 
CIVIL PENALTIES RELATING TO FOODS.—Chapter III of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331 
et seq.) is amended by adding at the end the following: 
‘‘SEC. 311. NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED ARTI-
CLES OF FOOD. 
‘‘(a) NOTIFICATION TO SECRETARY OF VIOLATION.— 
‘‘(1) IN
GENERAL.—A person (other than a 
household consumer or other individual who is the 
intended consumer of an article of food) that has 
reason to believe that an article of food when intro-
duced into or while in interstate commerce, or while 
held for sale (regardless of whether the first sale) 
after shipment in interstate commerce, is adulter-
ated or misbranded in a manner that, if consumed, 
may result in illness or injury shall, as soon as prac-
ticable, notify the Secretary of the identity and loca-
tion of the article. 
‘‘(2) MANNER OF NOTIFICATION.—Notification 
under paragraph (1) shall be made in such manner 
and by such means as the Secretary may require by 
regulation. 
‘‘(b) RECALL AND CONSUMER NOTIFICATION.— 
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‘‘(1) VOLUNTARY ACTIONS.—On receiving noti-
fication under subsection (a) or by other means, if 
the Secretary finds that an article of food when in-
troduced into or while in interstate commerce, or 
while held for sale (regardless of whether the first 
sale) after shipment in interstate commerce, is adul-
terated or misbranded in a manner that, if con-
sumed, may result in illness or injury (as determined 
by the Secretary), the Secretary shall provide all ap-
propriate persons (including the manufacturer, im-
porter, distributor, or retailer of the article) with an 
opportunity (as determined by the Secretary)— 
‘‘(A) to cease distribution of the article; 
‘‘(B) to notify all persons— 
‘‘(i) that produce, manufacture, pack, 
process, prepare, treat, package, distribute, 
or hold the article, to cease immediately 
those activities with respect to the article; 
or 
‘‘(ii) to which the article has been dis-
tributed, transported, or sold, to cease im-
mediately distribution of the article; 
‘‘(C) to recall the article; 
‘‘(D) in consultation with the Secretary, to 
provide notice of the finding of the Secretary to 
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all consumers to which the article was, or may 
have been, distributed and to appropriate State 
and local health officials; or 
‘‘(E) to notify State and local public health 
officials. 
‘‘(2) MANDATORY ACTIONS.—If the appropriate 
person referred to in paragraph (1) does not carry 
out the actions described in that paragraph with re-
spect to an article within the time period and in the 
manner prescribed by the Secretary, the Secretary— 
‘‘(A) shall require the person— 
‘‘(i) to immediately cease distribution 
of the article; and 
‘‘(ii) to immediately make the notifica-
tion described in paragraph (1)(B); and 
‘‘(B) may take control or possession of the 
article. 
‘‘(3) NOTICE TO CONSUMERS AND HEALTH OF-
FICIALS.—The Secretary shall, as the Secretary de-
termines to be necessary, provide notice of the find-
ing of the Secretary under paragraph (1) to con-
sumers to which the article was, or may have been, 
distributed and to appropriate State and local health 
officials. 
‘‘(c) HEARINGS ON ORDERS.— 
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‘‘(1) IN GENERAL.—The Secretary shall provide 
a person subject to an order under subsection (b) 
with an opportunity for a hearing on— 
‘‘(A) the actions required by the order; and 
‘‘(B) any reasons why the article of food 
that is the subject of the order should not be 
recalled. 
‘‘(2) TIMING
OF
HEARINGS.—The Secretary 
shall hold a hearing under paragraph (1) as soon as 
practicable, but not later than 2 business days, after 
the date of issuance of the order. 
‘‘(d) POST-HEARING RECALL ORDERS.— 
‘‘(1) AMENDMENT OF ORDERS.—If, after pro-
viding an opportunity for a hearing under subsection 
(c), the Secretary determines that an article of food 
when introduced into or while in interstate com-
merce, or while held for sale (regardless of whether 
the first sale) after shipment in interstate commerce, 
is adulterated or misbranded in a manner that, if 
consumed, may result in illness or injury, the Sec-
retary may, as the Secretary determines to be nec-
essary— 
‘‘(A) amend the order under subsection 
(b)— 
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‘‘(i) to require recall of the article or 
other appropriate action; and 
‘‘(ii) to specify a timetable during 
which the recall shall occur; 
‘‘(B) require periodic reports to the Sec-
retary describing the progress of the recall; or 
‘‘(C) provide notice of the recall to con-
sumers to which the article was, or may have 
been, distributed. 
‘‘(2) VACATION OF ORDERS.—If, after providing 
an opportunity for a hearing under subsection (c), 
the Secretary determines that adequate grounds do 
not exist to continue the actions required by the 
order, the Secretary shall vacate the order. 
‘‘(e) REMEDIES NOT EXCLUSIVE.—The remedies au-
thorized by this section shall be in addition to any other 
remedies that may be available. 
‘‘SEC. 312. CIVIL PENALTIES RELATING TO FOODS. 
‘‘(a) IN GENERAL.— 
‘‘(1) ASSESSMENT.—The Secretary may assess 
against a person that commits an act prohibited by 
section 301 with respect to an article of food a civil 
penalty for each such act of not more than— 
‘‘(A) $100,000, in the case of an indi-
vidual; and 
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‘‘(B) $500,000, in the case of any other 
person. 
‘‘(2) SEPARATE
OFFENSES.—Each prohibited 
act and each day during which the act continues 
shall be considered to be a separate offense. 
‘‘(3) NOTICE
AND
OPPORTUNITY
FOR
HEAR-
ING.—The Secretary shall not assess a civil penalty 
under this section against a person unless the person 
is given notice and opportunity for a hearing on the 
record before the Secretary in accordance with sec-
tions 554 and 556 of title 5, United States Code. 
‘‘(4) DETERMINATION
OF
CIVIL
PENALTY 
AMOUNT.—The amount of a civil penalty under this 
section— 
‘‘(A) shall be assessed by the Secretary by 
written order, taking into account— 
‘‘(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; and 
‘‘(B) shall be reviewed only in accordance 
with subsection (b). 
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‘‘(b) JUDICIAL REVIEW.— 
‘‘(1) IN GENERAL.—An order assessing a civil 
penalty against a person under subsection (a) shall 
be final unless the person— 
‘‘(A) not later than 30 days after the effec-
tive date of the order, files a petition for judi-
cial review of the order in— 
‘‘(i) the United States court of ap-
peals for the circuit in which the person re-
sides or has its principal place of business; 
or 
‘‘(ii) the United States Court of Ap-
peals for the District of Columbia Circuit; 
and 
‘‘(B) simultaneously sends a copy of the 
petition by certified mail to the Secretary. 
‘‘(2) FILING OF COPY OF RECORD.—The Sec-
retary shall promptly file in the court a certified 
copy of the record on which the order was issued. 
‘‘(3) STANDARD OF REVIEW.—The findings of 
the Secretary relating to the order shall be set aside 
only if the findings are found to be unsupported by 
substantial evidence on the record as a whole. 
‘‘(c) COLLECTION ACTIONS FOR FAILURE TO PAY 
ASSESSMENT.— 
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‘‘(1) REFERRAL TO ATTORNEY GENERAL.—If a 
person fails to pay a civil penalty assessed under 
subsection (a) after the order assessing the civil pen-
alty has become a final order, or after the court of 
appeals has entered final judgment in favor of the 
Secretary, the Secretary may refer the matter to the 
Attorney General. 
‘‘(2) ACTION
BY
ATTORNEY
GENERAL.—The 
Attorney General shall bring a civil action to recover 
the amount of the civil penalty in United States dis-
trict court. 
‘‘(3) SCOPE
OF
REVIEW.—In a civil action 
under paragraph (2), the validity and appropriate-
ness of the order of the Secretary assessing the civil 
penalty shall not be subject to review. 
‘‘(d) PENALTIES DEPOSITED
IN TREASURY.—All 
amounts collected as civil penalties under this section shall 
be deposited in the Treasury of the United States. 
‘‘(e) PENALTIES IN LIEU OF OTHER ACTIONS.— 
Nothing in this Act requires the Secretary to report for 
prosecution, or for the commencement of any libel or in-
junction proceeding, any violation of this Act in any case 
in which the Secretary believes that the public interest will 
be adequately served by the assessment of a civil penalty 
under this section. 
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‘‘(f) REMEDIES NOT EXCLUSIVE.—The remedies au-
thorized by this section shall be in addition to any other 
remedies that may be available.’’. 
Æ 
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