| S 2803 IS
107th CONGRESS
2d Session
S. 2803
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 SENATE OF THE UNITED
STATES
July 26, 2002
Mr. HARKIN (for himself and
Mr. CONRAD) introduced the following bill; which was read twice and referred
to the Committee on Agriculture, Nutrition, and Forestry
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 Representatives of the United States of America in
Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as
the `Safe and Fair Enforcement 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 ARTICLES.
`(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 otherwise handled by
the person is adulterated or misbranded shall, as soon as practicable,
notify 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 notification under subsection (a) or by other means, if the
Secretary finds that an article is adulterated or misbranded and that there
is a reasonable probability that human consumption of the article would
present a threat to public health (as determined by the Secretary), the
Secretary shall provide all appropriate 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 respect 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 PERSONS- A person that transports, stores, distributes, or otherwise
handles the article, or to which the article has been transported, sold,
distributed, or otherwise handled, and that is notified under paragraph
(1)(B) or (2)(B) shall cease immediately distribution of the article.
`(5) AVAILABILITY OF RECORDS
TO SECRETARY- 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, distribute, or otherwise handle the article; and
`(B) persons to which the
article has been transported, sold, distributed, or otherwise handled.
`(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 accordance with such rules or regulations
as the Secretary 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 providing 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 subsection (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 Secretary describing the progress of the recall; or
`(C) provide notice of the
recall to consumers to which the article was, or may have been, distributed.
`(2) VACATION OF ORDERS-
If, after providing an opportunity for an informal 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 authorized by this section shall be in addition to any other
remedies that may be available.
`SEC. 412. REFUSAL OR WITHDRAWAL
OF INSPECTION OF ESTABLISHMENTS.
`(a) IN GENERAL- The Secretary
may, for such period, or indefinitely, as the Secretary considers necessary
to carry out this Act, refuse to provide or withdraw inspection 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 person responsibly
connected with the applicant or recipient (within the meaning of section
401), has committed a willful violation or repeated violations of this
Act (including a regulation promulgated under this Act).
`(b) DENIAL OR SUSPENSION
OF INSPECTION PENDING HEARING- The Secretary may deny or suspend inspection
under title I, pending opportunity for an expedited hearing, with respect
to an action under subsection (a), if the Secretary determines that the
denial or suspension is in the public interest to protect the health or
welfare of consumers or to ensure the effective performance of an official
duty under this Act.
`(1) IN GENERAL- A determination
and order of the Secretary with respect to the refusal or withdrawal 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 recipient 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 INSPECTION 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--
`(i) the United States court
of appeals 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 Appeals for the District of Columbia Circuit; and
`(B) on the record on which
the determination and order are based.
`(d) REMEDIES NOT EXCLUSIVE-
The remedies authorized by this section shall be in addition to any other
remedies that may be available.
`SEC. 413. CIVIL PENALTIES.
`(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 HEARING- 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 sections
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).
`(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 effective date of the order, files a petition for judicial review
of the order in--
`(i) the United States court
of appeals for the circuit in which the person resides or has its principal
place of business; or
`(ii) the United States
Court of Appeals 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 Secretary 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 penalty 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 district court.
`(3) SCOPE OF REVIEW- In
a civil action under paragraph (2), the validity and appropriateness 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 provide 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 authorized 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 individual, partnership, corporation, association, or other business
unit.'.
(2) The Federal Meat Inspection
Act (21 U.S.C. 601 et seq.) is amended--
(A) by striking `person,
firm, or corporation' each place it appears and inserting `person';
(B) by striking `persons,
firms, and corporations' each place it appears and inserting `persons';
and
(C) by striking `persons,
firms, or corporations' each place it appears and inserting `persons'.
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 ARTICLES.
`(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, distributed, or otherwise handled by the person is adulterated
or misbranded shall, as soon as practicable, notify 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 notification under subsection (a) or by other means, if the
Secretary finds that an article is adulterated or misbranded and that there
is a reasonable probability that human consumption of the article would
present a threat to public health (as determined by the Secretary), the
Secretary shall provide all appropriate 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 respect 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 PERSONS- A person that transports, stores, distributes, or otherwise
handles the article, or to which the article has been transported, sold,
distributed, or otherwise handled, and that is notified under paragraph
(1)(B) or (2)(B) shall cease immediately distribution of the article.
`(5) AVAILABILITY OF RECORDS
TO SECRETARY- 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, distribute, or otherwise handle the article; and
`(B) persons to which the
article has been transported, sold, distributed, or otherwise handled.
`(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 accordance with such rules or regulations
as the Secretary 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 providing 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
subsection (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 Secretary describing the progress of the recall; or
`(C) provide notice of the
recall to consumers to which the article was, or may have been, distributed.
`(2) VACATION OF ORDERS-
If, after providing an opportunity for an informal 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 authorized 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 period, or indefinitely, as the Secretary considers necessary
to carry out this Act, refuse to provide or withdraw inspection 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 person
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 (including a regulation promulgated under this Act).
`(b) DENIAL OR SUSPENSION
OF INSPECTION PENDING HEARING- The Secretary may deny or suspend inspection
under this Act, pending opportunity for an expedited hearing, with respect
to an action under subsection (a), if the Secretary determines that the
denial or suspension is in the public interest to protect the health or
welfare of consumers or to ensure the effective performance of an official
duty under this Act.
`(1) IN GENERAL- A determination
and order of the Secretary with respect to the refusal or withdrawal 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 recipient 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 INSPECTION 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--
`(i) the United States court
of appeals 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 Appeals for the District of Columbia Circuit; and
`(B) on the record on which
the determination and order are based.
`(d) REMEDIES NOT EXCLUSIVE-
The remedies authorized by this section shall be in addition to any other
remedies that may be available.
`SEC. 33. CIVIL PENALTIES.
`(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 HEARING- 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 sections
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).
`(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 effective date of the order, files a petition for judicial review
of the order in--
`(i) the United States court
of appeals for the circuit in which the person resides or has its principal
place of business; or
`(ii) the United States
Court of Appeals 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 Secretary 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 penalty 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 district court.
`(3) SCOPE OF REVIEW- In
a civil action under paragraph (2), the validity and appropriateness 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 provide 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 authorized 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 ARTICLES OF FOOD.
(a) PROHIBITED ACTS- Section
301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended
by adding at the end the following:
`(gg)(1) The failure to
notify the Secretary in violation 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 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 ARTICLES 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 introduced into or while in interstate commerce, 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 shall, as soon as practicable,
notify 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 notification under subsection (a) or by other means, if the
Secretary finds that an article of food when introduced into or while in
interstate commerce, 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 (as determined
by the Secretary), the Secretary shall provide all appropriate persons
(including the manufacturer, importer, 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 distributed, transported, or sold, 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 respect 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.
`(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 providing an opportunity for a hearing under subsection (c),
the Secretary determines that an article of food when introduced into or
while in interstate commerce, 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 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 Secretary describing the progress of the recall; or
`(C) provide notice of the
recall to consumers 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 authorized by this section shall be in addition to any other
remedies that may be available.
`SEC. 312. CIVIL PENALTIES RELATING
TO FOODS.
`(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 individual; 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 HEARING- 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 sections
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).
`(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 effective date of the order, files a petition for judicial review
of the order in--
`(i) the United States court
of appeals for the circuit in which the person resides or has its principal
place of business; or
`(ii) the United States
Court of Appeals 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 Secretary 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 penalty 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 district court.
`(3) SCOPE OF REVIEW- In
a civil action under paragraph (2), the validity and appropriateness 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 injunction 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 authorized by this section shall be in addition to any other
remedies that may be available.'.
END
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