I
107TH CONGRESS
2D SESSION
H. R. 5230
To amend the Federal Meat Inspection Act, the Poultry Products Inspection
Act, and the Federal Food, Drug, and Cosmetic Act to provide for
improved public health and food safety through enhanced enforcement,
and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
JULY 25, 2002
Ms. RIVERS (for herself and Ms. DEGETTE) introduced the following bill;
which was referred to the Committee on Agriculture, and in addition to
the Committee on Energy and Commerce, for a period to be subsequently
determined by the Speaker, in each case for consideration of such provi-
sions as fall within the jurisdiction of the committee concerned
A BILL
To amend the Federal Meat Inspection Act, the Poultry
Products Inspection Act, and the Federal Food, Drug,
and Cosmetic Act to provide for improved public health
and food safety through enhanced enforcement, and for
other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Safe And Fair En-
forcement and Recall for Meat, Poultry, and Food Act’’
(SAFER Meat, Poultry, and Food Act).
SEC. 2. FOOD SAFETY ENFORCEMENT FOR MEAT AND MEAT
FOOD PRODUCTS.
(a) IN GENERAL.—The Federal Meat Inspection Act
(21 U.S.C. 601 et seq.) is amended—
(1) by redesignating section 411 (21 U.S.C.
680) as section 414; and
(2) by inserting after section 410 (21 U.S.C.
679a) the following:
‘‘SEC. 411. NOTIFICATION, NONDISTRIBUTION, AND RECALL
OF ADULTERATED OR MISBRANDED ARTI-
CLES.
‘‘(a) NOTIFICATION TO SECRETARY OF VIOLATION.—
‘‘(1) IN
GENERAL.—A person (other than a
household consumer) that has reason to believe that
any carcass, part of a carcass, meat, or meat food
product of cattle, sheep, swine, goats, horses, mules,
or other equines (referred to in this section as an
‘article’) transported, stored, distributed, or other-
wise handled by the person is adulterated or mis-
branded shall, as soon as practicable, notify the Sec-
retary of the identity and location 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.—
‘‘(1) VOLUNTARY ACTIONS.—On receiving noti-
fication under subsection (a) or by other means, if
the Secretary finds that an article is adulterated or
misbranded and that there is a reasonable prob-
ability that human consumption of the article would
present a threat to public health (as determined by
the Secretary), the Secretary shall provide all appro-
priate persons (as determined by the Secretary),
that transported, stored, distributed, or otherwise
handled the article with an opportunity—
‘‘(A) to cease distribution of the article;
‘‘(B) to notify all persons that transport,
store, distribute, or otherwise handle the article,
or to which the article has been transported,
sold, distributed, or otherwise handled, to cease
immediately distribution of the article;
‘‘(C) to recall the article; or
‘‘(D) in consultation with the Secretary, to
provide notice of the finding of the Secretary to
all consumers to which the article was, or may
have been, distributed.
‘‘(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
shall, by order, require, as the Secretary determines
to be necessary, the person—
‘‘(A) to cease immediately distribution of
the article; and
‘‘(B) to make immediately the notification
described in paragraph (1)(B).
‘‘(3) NOTICE TO CONSUMERS.—The Secretary
shall, as the Secretary determines to be necessary,
provide notice of the finding of the Secretary under
paragraph (1) to consumers to which the article was,
or may have been, distributed.
‘‘(4) NONDISTRIBUTION
BY
NOTIFIED
PER-
SONS.—A person that transports, stores, distributes,
or otherwise handles the article, or to which the arti-
cle has been transported, sold, distributed, or other-
wise handled, and that is notified under paragraph
(1)(B) or (2)(B) shall cease immediately distribution
of the article.
‘‘(5) AVAILABILITY
OF
RECORDS
TO
SEC-
RETARY.—Each appropriate person referred to in
paragraph (1) that transported, stored, distributed,
or otherwise handled an article shall make available
to the Secretary information necessary to carry out
this subsection, as determined by the Secretary,
regarding—
‘‘(A) persons that transport, store, dis-
tribute, or otherwise handle the article; and
‘‘(B) persons to which the article has been
transported, sold, distributed, or otherwise han-
dled.
‘‘(c) INFORMAL HEARINGS ON ORDERS.—
‘‘(1) IN GENERAL.—The Secretary shall provide
a person subject to an order under subsection (b)
with an opportunity for an informal hearing (in ac-
cordance with such rules or regulations as the Sec-
retary shall prescribe) on—
‘‘(A) the actions required by the order; and
‘‘(B) any reasons why the article 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 an informal hearing under
subsection (c), the Secretary determines that there is
a reasonable probability that human consumption of
‘‘SEC. 412. 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 title I 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 401), has committed a will-
ful violation or repeated violations of this Act (including
a regulation promulgated under this Act).
‘‘(b) DENIAL OR SUSPENSION OF INSPECTION PEND-
ING HEARING.—The Secretary may deny or suspend in-
spection under title I, 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
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.
‘‘(d) REMEDIES NOT EXCLUSIVE.—The remedies au-
thorized by this section shall be in addition to any other
remedies that may be available.
‘‘SEC. 413. 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;
‘‘(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.
‘‘(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 title I of the person
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.’’.
(b) CONFORMING AMENDMENTS.—
(1) Section 1 of the Federal Meat Inspection
Act (21 U.S.C. 601) is amended by adding at the
end the following:
‘‘(w) PERSON.—The term ‘person’ means any indi-
vidual, partnership, corporation, association, or other busi-
ness unit.’’.
(2) The Federal Meat Inspection Act (21
U.S.C. 601 et seq.) is amended—
(A) by striking ‘‘person, firm, or corpora-
tion’’ each place it appears and inserting ‘‘per-
son’’;
(B) by striking ‘‘persons, firms, and cor-
porations’’ each place it appears and inserting
‘‘persons’’; and
(C) by striking ‘‘persons, firms, or corpora-
tions’’ each place it appears and inserting ‘‘per-
sons’’.
SEC. 3. FOOD SAFETY ENFORCEMENT FOR POULTRY AND
POULTRY FOOD PRODUCTS.
The Poultry Products Inspection Act (21 U.S.C. 451
et seq.) is amended—
(1) in the first sentence of section 5(c)(1) (21
U.S.C. 454(c)(1))—
(A) by striking ‘‘, by thirty days prior to
the expiration of two years after enactment of
the Wholesome Poultry Products Act,’’; and
(B) by striking ‘‘sections 1–4, 6–10, and
12–22 of this Act’’ and inserting ‘‘sections 1
through 4, 6 through 10, 12 through 22, and
31 through 33’’; and
(2) by adding at the end the following:
‘‘SEC. 31. NOTIFICATION, NONDISTRIBUTION, AND RECALL
OF ADULTERATED OR MISBRANDED ARTI-
CLES.
‘‘(a) NOTIFICATION TO SECRETARY OF VIOLATION.—
‘‘(1) IN
GENERAL.—A person (other than a
household consumer) that has reason to believe that
any poultry or poultry product (referred to in this
section as an ‘article’) transported, stored, distrib-
uted, or otherwise handled by the person is adulter-
ated or misbranded shall, as soon as practicable, no-
tify the Secretary of the identity and location 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.—
‘‘(1) VOLUNTARY ACTIONS.—On receiving noti-
fication under subsection (a) or by other means, if
the Secretary finds that an article is adulterated or
misbranded and that there is a reasonable prob-
ability that human consumption of the article would
present a threat to public health (as determined by
the Secretary), the Secretary shall provide all appro-
priate persons (as determined by the Secretary),
that transported, stored, distributed, or otherwise
handled the article with an opportunity—
‘‘(A) to cease distribution of the article;
‘‘(B) to notify all persons that transport,
store, distribute, or otherwise handle the article,
or to which the article has been transported,
sold, distributed, or otherwise handled, to cease
immediately distribution of the article;
‘‘(C) to recall the article; or
‘‘(D) in consultation with the Secretary, to
provide notice of the finding of the Secretary to
all consumers to which the article was, or may
have been, distributed.
‘‘(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
shall, by order, require, as the Secretary determines
to be necessary, the person—
‘‘(A) to cease immediately distribution of
the article; and
‘‘(B) to make immediately the notification
described in paragraph (1)(B).
‘‘(3) NOTICE TO CONSUMERS.—The Secretary
shall, as the Secretary determines to be necessary,
provide notice of the finding of the Secretary under
paragraph (1) to consumers to which the article was,
or may have been, distributed.
‘‘(4) NONDISTRIBUTION
BY
NOTIFIED
PER-
SONS.—A person that transports, stores, distributes,
or otherwise handles the article, or to which the arti-
cle has been transported, sold, distributed, or other-
wise handled, and that is notified under paragraph
(1)(B) or (2)(B) shall cease immediately distribution
of the article.
‘‘(5) AVAILABILITY
OF
RECORDS
TO
SEC-
RETARY.—Each appropriate person referred to in
paragraph (1) that transported, stored, distributed,
or otherwise handled an article shall make available
to the Secretary information necessary to carry out
this subsection, as determined by the Secretary,
regarding—
‘‘(A) persons that transport, store, dis-
tribute, or otherwise handle the article; and
‘‘(B) persons to which the article has been
transported, sold, distributed, or otherwise han-
dled.
‘‘(c) INFORMAL HEARINGS ON ORDERS.—
‘‘(1) IN GENERAL.—The Secretary shall provide
a person subject to an order under subsection (b)
with an opportunity for an informal hearing (in ac-
cordance with such rules or regulations as the Sec-
retary shall prescribe) on—
‘‘(A) the actions required by the order; and
‘‘(B) any reasons why the article 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 an informal hearing under
subsection (c), the Secretary determines that there is
a reasonable probability that human consumption of
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.
‘‘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
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.
‘‘(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;
‘‘(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.
‘‘(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
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:
‘‘(gg)(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) fol-
lowing any hearing requested under section 311(c);
or
‘‘(B) an amended order issued under section
311(d)(1).’’.
(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.—
‘‘(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; or
‘‘(D) in consultation with the Secretary, to
provide notice of the finding of the Secretary to
all consumers to which the article was, or may
have been, distributed.
‘‘(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
shall, by order, require, as the Secretary determines
to be necessary, the person—
‘‘(A) to cease immediately distribution of
the article; and
‘‘(B) to make immediately the notification
described in paragraph (1)(B).
‘‘(3) NOTICE TO CONSUMERS.—The Secretary
shall, as the Secretary determines to be necessary,
provide notice of the finding of the Secretary under
paragraph (1) to consumers to which the article was,
or may have been, distributed.
‘‘(c) HEARINGS ON ORDERS.—
‘‘(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
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 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
‘‘(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).
‘‘(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.
‘‘(4) 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.—
‘‘(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.
‘‘(f) REMEDIES NOT EXCLUSIVE.—The remedies au-
thorized by this section shall be in addition to any other
remedies that may be available.’’.
Æ