[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 3267 Introduced in Senate (IS)]
110th CONGRESS
2d Session
S. 3267
To amend the Federal Meat Inspection Act, the Poultry Products
Inspection Act, the Egg 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 15, 2008
Mr. Brown 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, the Egg 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 of 2008'' or ``SAFER Meat, Poultry, and
Food Act of 2008''.
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;
``(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; 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 respect 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 notification
described in paragraph (1)(B); and
``(B) may take control or possession of the
article.
``(3) Notice to consumers and health officials.--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 and to appropriate State and local public health
officials.
``(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;
``(C) provide notice of the recall to consumers to
which the article was, or may have been, distributed;
or
``(D) take any combination of actions described in
subparagraphs (A) through (C).
``(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.
``(c) Judicial Review.--
``(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--
``(A) in--
``(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.
``(a) In General.--
``(1) Assessment.--The Secretary may assess against a
person that violates section 411 (including a regulation
promulgated or order issued under that section) 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).
``(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 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 section 411 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:
``(x) 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;
``(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; 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 respect 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 notification
described in paragraph (1)(B); and
``(B) may take control or possession of the
article.
``(3) Notice to consumers and health officials.--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 and to appropriate State and local health
officials.
``(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.
``(c) Judicial Review.--
``(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--
``(A) in--
``(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.
``(a) In General.--
``(1) Assessment.--The Secretary may assess against a
person that violates section 31 (including a regulation
promulgated or order issued under that section) 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).
``(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 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 section 31 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 EGGS AND EGG PRODUCTS.
The Egg Products Inspection Act is amended by inserting after
section 20 (21 U.S.C. 1049) the following:
``SEC. 20A. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR
MISBRANDED EGGS AND EGG PRODUCTS.
``(a) Notification to Secretary of Violation.--
``(1) In general.--A person (other than a household
consumer) that has reason to believe that any egg or egg
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;
``(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; 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 respect 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 notification
described in paragraph (1)(B); and
``(B) may take control or possession of the
article.
``(3) Notice to consumers and health officials.--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 and to appropriate State and local health
officials.
``(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. 20B. 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), 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.
``(c) Judicial Review.--
``(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--
``(A) in--
``(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. 20C. CIVIL PENALTIES.
``(a) In General.--
``(1) Assessment.--The Secretary may assess against a
person that violates section 20A (including a regulation
promulgated or order issued under that section) 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).
``(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 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 section 20A 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. 5. 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:
``(oo)(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;
``(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 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 respect 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 notification
described in paragraph (1)(B); and
``(B) may take control or possession of the
article.
``(3) Notice to consumers and health officials.--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 and to appropriate State and local health
officials.
``(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 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.
``(a) In General.--
``(1) Assessment.--The Secretary may assess against a
person that commits an act prohibited by section 301(oo) 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).
``(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 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.
``(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.--
``(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
section 301(oo) 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.''.
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