[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.''.
                                 <all>