[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 1534 Introduced in Senate (IS)]








109th CONGRESS
  1st Session
                                S. 1534

 To reduce the risk to the food supply from intentional contamination, 
                        and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 28, 2005

 Mr. Durbin (for himself and Mr. Akaka) introduced the following bill; 
  which was read twice and referred to the Committee on Agriculture, 
                        Nutrition, and Forestry

_______________________________________________________________________

                                 A BILL


 
 To reduce the risk to the food supply from intentional contamination, 
                        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; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Safe and Secure 
Food Act of 2005''.
    (b) Table of Contents.--

Sec. 1. Short title; table of contents.
                         TITLE I--FOOD SECURITY

                 Subtitle A--Department of Agriculture

Sec. 101. Food security for meat and meat food products.
Sec. 102. Food security for poultry and poultry food products.
Sec. 103. Food security for eggs and egg products.
Sec. 104. Confidentiality of information.
                Subtitle B--Food and Drug Administration

Sec. 111. Food security for food products.
                     Subtitle C--Inspector Training

Sec. 121. Inspector training for food security.
                       TITLE II--RECALL AUTHORITY

                 Subtitle A--Department of Agriculture

Sec. 201. Food safety enforcement for meat and meat food products.
Sec. 202. Food safety enforcement for poultry and poultry food 
                            products.
Sec. 203. Food safety enforcement for eggs and egg products.
Sec. 204. Liability.
                Subtitle B--Food and Drug Administration

Sec. 211. Food safety enforcement for food.
Sec. 212. Liability.
                        TITLE III--IMPORTED FOOD

Sec. 301. Imported food.
             TITLE IV--RISK ASSESSMENT INFORMATION SHARING

Sec. 401. Risk assessment information sharing.

                         TITLE I--FOOD SECURITY

                 Subtitle A--Department of Agriculture

SEC. 101. FOOD SECURITY FOR MEAT AND MEAT FOOD PRODUCTS.

    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 
        415; and
            (2) by inserting after section 410 (21 U.S.C. 679a) the 
        following:

``SEC. 411. FOOD SECURITY.

    ``(a) In General.--The Secretary, in consultation with the 
Secretary of Health and Human Services, shall promulgate regulations 
that require persons to implement procedures to prevent both 
unintentional and intentional contamination of meat and meat food 
products at establishments covered by this Act.
    ``(b) Scope of Regulations.--The regulations shall require a person 
responsible for an establishment covered by this Act to implement 
security procedures for the entire establishment, as determined by the 
Secretary, including--
            ``(1) developing a security plan that addresses the 
        specific vulnerabilities of the establishment;
            ``(2) developing an emergency response plan for the 
        establishment;
            ``(3) securing establishment boundaries;
            ``(4) providing guards, alarms, and outside lighting, as 
        necessary;
            ``(5) performing background checks before hiring new 
        personnel;
            ``(6) limiting access to the establishment;
            ``(7) accounting for missing stock;
            ``(8) implementing mail-handling procedures; and
            ``(9) such other security procedures as the Secretary 
        determines to be necessary to prevent unintentional or 
        intentional contamination of meat and meat food products.
    ``(c) Training of Field Inspectors.--The Secretary shall provide 
training for field inspectors of the Food Safety and Inspection Service 
to monitor the implementation of the regulations described in 
subsection (a).''.

SEC. 102. FOOD SECURITY FOR POULTRY AND POULTRY FOOD PRODUCTS.

    (a) In General.--The Poultry Products Inspection Act (21 U.S.C. 451 
et seq.) is amended--
            (1) by redesignating sections 26 through 29 as sections 31 
        through 34 and moving those sections to the end of that Act;
            (2) by redesignating section 30 as section 26; and
            (3) by inserting after section 26 (as redesignated by 
        paragraph (2)) the following:

``SEC. 27. FOOD SECURITY.

    ``(a) In General.--The Secretary, in consultation with the 
Secretary of Health and Human Services, shall promulgate regulations 
that require persons to implement procedures to prevent both 
unintentional and intentional contamination of poultry and poultry food 
products at establishments covered by this Act.
    ``(b) Scope of Regulations.--The regulations shall require a person 
that is responsible for an establishment covered by this Act to 
implement security procedures for the entire establishment, as 
determined by the Secretary, including--
            ``(1) developing a security plan that addresses the 
        specific vulnerabilities of the establishment;
            ``(2) developing an emergency response plan for the 
        establishment;
            ``(3) securing establishment boundaries;
            ``(4) providing guards, alarms, and outside lighting, as 
        necessary;
            ``(5) performing background checks before hiring new 
        personnel;
            ``(6) limiting access to the establishment;
            ``(7) accounting for missing stock;
            ``(8) implementing mail-handling procedures; and
            ``(9) such other security procedures as the Secretary 
        determines to be necessary to prevent unintentional or 
        intentional contamination of poultry and poultry food products.
    ``(c) Training of Field Inspectors.--The Secretary shall provide 
training for field inspectors of the Food Safety and Inspection Service 
to monitor the implementation of the regulations described in 
subsection (a).''.
    (b) Conforming Amendments.--Section 5(c)(1) of the Poultry Products 
Inspection Act (21 U.S.C. 454(c)(1)) is amended in the first sentence--
            (1) by striking ``, by thirty days prior to the expiration 
        of two years after enactment of the Wholesome Poultry Products 
        Act,''; and
            (2) 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 27 through 30''.

SEC. 103. FOOD SECURITY FOR EGGS AND EGG PRODUCTS.

    The Egg Products Inspection Act (21 U.S.C. 1031 et seq.) is 
amended--
            (1) by redesignating sections 27 through 29 as sections 31 
        through 33, respectively;
            (2) by inserting after section 26 (21 U.S.C. 1054) the 
        following:

``SEC. 27. FOOD SECURITY.

    ``(a) In General.--The Secretary, in consultation with the 
Secretary of Health and Human Services, shall promulgate regulations 
that require persons to implement procedures to prevent both 
unintentional and intentional contamination of eggs and egg products at 
establishments covered by this Act.
    ``(b) Scope of Regulations.--The regulations shall require a person 
that is responsible for an establishment covered by this Act to 
implement security procedures for the entire establishment, as 
determined by the Secretary, including--
            ``(1) developing a security plan that addresses the 
        specific vulnerabilities of the establishment;
            ``(2) developing an emergency response plan for the 
        establishment;
            ``(3) securing establishment boundaries;
            ``(4) providing guards, alarms, and outside lighting, as 
        necessary;
            ``(5) performing background checks before hiring new 
        personnel;
            ``(6) limiting access to the establishment;
            ``(7) accounting for missing stock;
            ``(8) implementing mail-handling procedures; and
            ``(9) such other security procedures as the Secretary 
        determines to be necessary to prevent unintentional or 
        intentional contamination of eggs and egg products.
    ``(c) Training of Field Inspectors.--The Secretary shall provide 
training for field inspectors of the Food Safety and Inspection Service 
to monitor the implementation of the regulations described in 
subsection (a).''.

SEC. 104. CONFIDENTIALITY OF INFORMATION.

    Section 1770(d) of the Food Security Act of 1985 (7 U.S.C. 2276(d)) 
is amended--
            (1) in paragraph (11), by striking ``or''; and
            (2) by adding at the end the following:
            ``(13) section 411 of the Federal Meat Inspection Act;
            ``(14) section 31 of the Poultry Products Inspection Act; 
        or
            ``(15) section 27 of the Egg Products Inspection Act.''.

                Subtitle B--Food and Drug Administration

SEC. 111. FOOD SECURITY FOR FOOD PRODUCTS.

    (a) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 341 et seq.) is amended by adding at the end the 
following:

``SEC. 416. FOOD SECURITY.

    ``(a) In General.--The Secretary, in consultation with the 
Secretary of Agriculture, shall promulgate regulations that require 
persons to implement procedures to prevent both unintentional and 
intentional contamination of food at domestic facilities covered by 
this Act.
    ``(b) Scope of Regulations.--The regulations shall--
            ``(1) direct food inspectors to check for the safety and 
        security of food during an inspection of a domestic facility; 
        and
            ``(2) require a person that is responsible for a domestic 
        facility to implement security procedures for the entire 
        domestic facility, as determined by the Secretary, including--
                    ``(A) developing a security plan that addresses the 
                specific vulnerabilities of the facility;
                    ``(B) developing an emergency response plan for the 
                facility;
                    ``(C) securing establishment boundaries;
                    ``(D) providing guards, alarms, and outside 
                lighting, as necessary;
                    ``(E) performing background checks before hiring 
                new personnel;
                    ``(F) limiting access to the facility;
                    ``(G) accounting for missing stock;
                    ``(H) implementing mail-handling procedures; and
                    ``(I) such other security procedures as the 
                Secretary determines to be necessary to prevent 
                unintentional or intentional contamination of food.
    ``(c) Training of Field Inspectors.--The Secretary shall provide 
training for field inspectors of the Food and Drug Administration to 
monitor the implementation of the regulations described in subsection 
(a).
    ``(d) Protection of Information.--Information furnished under the 
regulations described in subsection (a) shall not be disclosed under 
section 552 of title 5, United States Code (commonly known as the 
Freedom of Information Act).
    ``(e) Definition.--In this section, the term `domestic facility' 
has the meaning given that term under section 415(b)(2).''.

                     Subtitle C--Inspector Training

SEC. 121. INSPECTOR TRAINING FOR FOOD SECURITY.

    (a) In General.--Not later than 180 days after the date of 
enactment of this Act, the Secretary of Agriculture, in consultation 
with the Secretary of Health and Human Services, shall develop, 
publish, and initiate implementation of a joint training program for 
individuals who perform inspections with respect to the food security 
regulations promulgated pursuant to the amendments made by this title.
    (b) Continuing Training.--As part of the training program 
implemented under subsection (a), the Secretary of Agriculture and the 
Secretary of Health and Human Services shall require individuals 
described in subsection (a) to meet training and retraining 
requirements, as determined by the Secretaries, at least once every 2 
years.

                       TITLE II--RECALL AUTHORITY

                 Subtitle A--Department of Agriculture

SEC. 201. 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 by adding after section 411 (as added by section 101) 
the following:

``SEC. 412. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR 
              MISBRANDED ARTICLES.

    ``(a) Notification to Secretary of Violation.--
            ``(1) In general.--A person (other than a household 
        consumer) that has reason to believe that any carcass, part of 
        a carcass, meat, or meat food product of cattle, sheep, swine, 
        goats, horses, mules, or other equines (referred to in this 
        section as an `article') transported, stored, distributed, or 
        otherwise handled by the person is adulterated or misbranded 
        shall, as soon as practicable, notify the Secretary of the 
        identity and location of the article.
            ``(2) Manner of notification.--Notification under paragraph 
        (1) shall be made in such manner and by such means as the 
        Secretary may require by regulation.
    ``(b) Recall and Consumer Notification.--
            ``(1) Voluntary actions.--On receiving notification under 
        subsection (a) or by other means, if the Secretary finds that 
        an article is adulterated or misbranded and that there is a 
        reasonable probability that human consumption of the article 
        would present a threat to public health (as determined by the 
        Secretary), the Secretary shall provide all appropriate persons 
        (as determined by the Secretary), that transported, stored, 
        distributed, or otherwise handled the article with an 
        opportunity--
                    ``(A) to cease distribution of the article;
                    ``(B) to notify all persons that transport, store, 
                distribute, or otherwise handle the article, or to 
                which the article has been transported, sold, 
                distributed, or otherwise handled, to cease immediately 
                distribution of the article;
                    ``(C) to recall the article; or
                    ``(D) in consultation with the Secretary, to 
                provide notice of the finding of the Secretary to all 
                consumers to which the article was, or may have been, 
                distributed.
            ``(2) Mandatory actions.--If the appropriate person 
        referred to in paragraph (1) does not carry out the actions 
        described in that paragraph with respect to an article within 
        the time period and in the manner prescribed by the Secretary, 
        the Secretary shall, by order, require, as the Secretary 
        determines to be necessary, the person--
                    ``(A) to cease immediately distribution of the 
                article; and
                    ``(B) to make immediately the notification 
                described in paragraph (1)(B).
            ``(3) Notice to consumers.--The Secretary shall, as the 
        Secretary determines to be necessary, provide notice of the 
        finding of the Secretary under paragraph (1) to consumers to 
        which the article was, or may have been, distributed.
            ``(4) Nondistribution by notified persons.--A person that 
        transports, stores, distributes, or otherwise handles the 
        article, or to which the article has been transported, sold, 
        distributed, or otherwise handled, and that is notified under 
        paragraph (1)(B) or (2)(B) shall cease immediately distribution 
        of the article.
            ``(5) Availability of records to secretary.--Each 
        appropriate person referred to in paragraph (1) that 
        transported, stored, distributed, or otherwise handled an 
        article shall make available to the Secretary information 
        necessary to carry out this subsection, as determined by the 
        Secretary, regarding--
                    ``(A) persons that transport, store, distribute, or 
                otherwise handle the article; and
                    ``(B) persons to which the article has been 
                transported, sold, distributed, or otherwise handled.
    ``(c) Informal Hearings on Orders.--
            ``(1) In general.--The Secretary shall provide a person 
        subject to an order under subsection (b) with an opportunity 
        for an informal hearing (in accordance with such rules or 
        regulations as the Secretary shall prescribe) on--
                    ``(A) the actions required by the order; and
                    ``(B) any reasons why the article that is the 
                subject of the order should not be recalled.
            ``(2) Timing of hearings.--The Secretary shall hold a 
        hearing under paragraph (1) as soon as practicable, but not 
        later than 2 business days, after the date of issuance of the 
        order.
    ``(d) Post-Hearing Recall Orders.--
            ``(1) Amendment of orders.--If, after providing an 
        opportunity for an informal hearing under subsection (c), the 
        Secretary determines that there is a reasonable probability 
        that human consumption of the article that is the subject of an 
        order under subsection (b) presents a threat to public health, 
        the Secretary may, as the Secretary determines to be 
        necessary--
                    ``(A) amend the order under subsection (b)--
                            ``(i) to require recall of the article or 
                        other appropriate action; and
                            ``(ii) to specify a timetable during which 
                        the recall shall occur;
                    ``(B) require periodic reports to the Secretary 
                describing the progress of the recall; or
                    ``(C) provide notice of the recall to consumers to 
                which the article was, or may have been, distributed.
            ``(2) Vacation of orders.--If, after providing an 
        opportunity for an informal hearing under subsection (c), the 
        Secretary determines that adequate grounds do not exist to 
        continue the actions required by the order, the Secretary shall 
        vacate the order.
    ``(e) Remedies Not Exclusive.--The remedies authorized by this 
section shall be in addition to any other remedies that may be 
available.

``SEC. 413. 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. 414. CIVIL PENALTIES.

    ``(a) In General.--
            ``(1) Assessment.--The Secretary may assess against a 
        person that commits a serious violation (as defined by the 
        Secretary by regulation) of this Act (including a regulation 
        promulgated or order issued under this Act) a civil penalty for 
        each violation of not more than $100,000.
            ``(2) Separate offenses.--Each violation and each day 
        during which the violation continues shall be considered to be 
        a separate offense.
            ``(3) Notice and opportunity for hearing.--The Secretary 
        shall not assess a civil penalty under this section against a 
        person unless the person is given notice and opportunity for a 
        hearing on the record before the Secretary in accordance with 
        sections 554 and 556 of title 5, United States Code.
            ``(4) Determination of civil penalty amount.--The amount of 
        a civil penalty under this section--
                    ``(A) shall be assessed by the Secretary by written 
                order, taking into account--
                            ``(i) the gravity of the violation;
                            ``(ii) the degree of culpability of the 
                        person;
                            ``(iii) the size and type of the business 
                        of the person; and
                            ``(iv) any history of prior offenses by the 
                        person under this Act; and
                    ``(B) shall be reviewed only in accordance with 
                subsection (b).
    ``(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.--Upon referral of a 
        matter under paragraph (1), the Attorney General shall bring a 
        civil action to recover the amount of the civil penalty in 
        United States district court.
            ``(3) Scope of review.--In a civil action under paragraph 
        (2), the validity and appropriateness of the order of the 
        Secretary assessing the civil penalty shall not be subject to 
        review.
    ``(d) Refusal or Withdrawal of Inspection Pending Payment.--If a 
person fails to pay the amount of a civil penalty after the order 
assessing the civil penalty has become a final order, the Secretary may 
refuse to provide or withdraw inspection under title I of the person 
until the civil penalty is paid or until the Secretary directs 
otherwise.
    ``(e) Penalties in Lieu of Other Actions.--Nothing in this Act 
requires the Secretary to report for prosecution, or for the 
commencement of an action, any violation of this Act in any case in 
which the Secretary believes that the public interest will be 
adequately served by the assessment of a civil penalty under this 
section.
    ``(f) Remedies Not Exclusive.--The remedies authorized by this 
section shall be in addition to any other remedies that may be 
available.''.
    (b) Criminal Penalties.--
            (1) Assaulting, resisting, or impeding certain persons.--
        Section 405 of the Federal Meat Inspection Act (21 U.S.C. 675) 
        is amended--
                    (A) in the first sentence, by striking ``not more 
                than $5,000'' and inserting ``under title 18, United 
                States Code,''; and
                    (B) in the second sentence, by striking ``not more 
                than $10,000'' and inserting ``under title 18, United 
                States Code,''.
            (2) Violations.--Section 406 of the Federal Meat Inspection 
        Act (21 U.S.C. 676) is amended--
                    (A) by striking ``of not more than $1,000,'' and 
                inserting ``under title 18, United States Code,''; and
                    (B) by striking ``of not more than $10,000,'' and 
                inserting ``under title 18, United States Code,''.
    (c) Conforming Amendments.--
            (1) Section 1 of the Federal Meat Inspection Act (21 U.S.C. 
        601) is amended by adding at the end the following:
    ``(w) Person.--The term `person' means any individual, partnership, 
corporation, association, or other business unit.''.
            (2) The Federal Meat Inspection Act (21 U.S.C. 601 et seq.) 
        is amended--
                    (A) by striking ``person, firm, or corporation'' 
                each place it appears and inserting ``person'';
                    (B) by striking ``persons, firms, and 
                corporations'' each place it appears and inserting 
                ``persons''; and
                    (C) by striking ``persons, firms, or corporations'' 
                each place it appears and inserting ``persons''.

SEC. 202. FOOD SAFETY ENFORCEMENT FOR POULTRY AND POULTRY FOOD 
              PRODUCTS.

    (a) In General.--The Poultry Products Inspection Act (21 U.S.C. 451 
et seq.) (as amended by section 102) is amended by inserting after 
section 27 (as added by section 102(a)(3)) the following:

``SEC. 28. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR 
              MISBRANDED ARTICLES.

    ``(a) Notification to Secretary of Violation.--
            ``(1) In general.--A person (other than a household 
        consumer) that has reason to believe that any poultry or 
        poultry product (referred to in this section as an `article') 
        transported, stored, distributed, or otherwise handled by the 
        person is adulterated or misbranded shall, as soon as 
        practicable, notify the Secretary of the identity and location 
        of the article.
            ``(2) Manner of notification.--Notification under paragraph 
        (1) shall be made in such manner and by such means as the 
        Secretary may require by regulation.
    ``(b) Recall and Consumer Notification.--
            ``(1) Voluntary actions.--On receiving notification under 
        subsection (a) or by other means, if the Secretary finds that 
        an article is adulterated or misbranded and that there is a 
        reasonable probability that human consumption of the article 
        would present a threat to public health (as determined by the 
        Secretary), the Secretary shall provide all appropriate persons 
        (as determined by the Secretary), that transported, stored, 
        distributed, or otherwise handled the article with an 
        opportunity--
                    ``(A) to cease distribution of the article;
                    ``(B) to notify all persons that transport, store, 
                distribute, or otherwise handle the article, or to 
                which the article has been transported, sold, 
                distributed, or otherwise handled, to cease immediately 
                distribution of the article;
                    ``(C) to recall the article; or
                    ``(D) in consultation with the Secretary, to 
                provide notice of the finding of the Secretary to all 
                consumers to which the article was, or may have been, 
                distributed.
            ``(2) Mandatory actions.--If the appropriate person 
        referred to in paragraph (1) does not carry out the actions 
        described in that paragraph with respect to an article within 
        the time period and in the manner prescribed by the Secretary, 
        the Secretary shall, by order, require, as the Secretary 
        determines to be necessary, the person--
                    ``(A) to cease immediately distribution of the 
                article; and
                    ``(B) to make immediately the notification 
                described in paragraph (1)(B).
            ``(3) Notice to consumers.--The Secretary shall, as the 
        Secretary determines to be necessary, provide notice of the 
        finding of the Secretary under paragraph (1) to consumers to 
        which the article was, or may have been, distributed.
            ``(4) Nondistribution by notified persons.--A person that 
        transports, stores, distributes, or otherwise handles the 
        article, or to which the article has been transported, sold, 
        distributed, or otherwise handled, and that is notified under 
        paragraph (1)(B) or (2)(B) shall cease immediately distribution 
        of the article.
            ``(5) Availability of records to secretary.--Each 
        appropriate person referred to in paragraph (1) that 
        transported, stored, distributed, or otherwise handled an 
        article shall make available to the Secretary information 
        necessary to carry out this subsection, as determined by the 
        Secretary, regarding--
                    ``(A) persons that transport, store, distribute, or 
                otherwise handle the article; and
                    ``(B) persons to which the article has been 
                transported, sold, distributed, or otherwise handled.
    ``(c) Informal Hearings on Orders.--
            ``(1) In general.--The Secretary shall provide a person 
        subject to an order under subsection (b) with an opportunity 
        for an informal hearing (in accordance with such rules or 
        regulations as the Secretary shall prescribe) on--
                    ``(A) the actions required by the order; and
                    ``(B) any reasons why the article that is the 
                subject of the order should not be recalled.
            ``(2) Timing of hearings.--The Secretary shall hold a 
        hearing under paragraph (1) as soon as practicable, but not 
        later than 2 business days, after the date of issuance of the 
        order.
    ``(d) Post-Hearing Recall Orders.--
            ``(1) Amendment of orders.--If, after providing an 
        opportunity for an informal hearing under subsection (c), the 
        Secretary determines that there is a reasonable probability 
        that human consumption of the article that is the subject of an 
        order under subsection (b) presents a threat to public health, 
        the Secretary may, as the Secretary determines to be 
        necessary--
                    ``(A) amend the order under subsection (b)--
                            ``(i) to require recall of the article or 
                        other appropriate action; and
                            ``(ii) to specify a timetable during which 
                        the recall shall occur;
                    ``(B) require periodic reports to the Secretary 
                describing the progress of the recall; or
                    ``(C) provide notice of the recall to consumers to 
                which the article was, or may have been, distributed.
            ``(2) Vacation of orders.--If, after providing an 
        opportunity for an informal hearing under subsection (c), the 
        Secretary determines that adequate grounds do not exist to 
        continue the actions required by the order, the Secretary shall 
        vacate the order.
    ``(e) Remedies Not Exclusive.--The remedies authorized by this 
section shall be in addition to any other remedies that may be 
available.

``SEC. 29. 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. 30. CIVIL PENALTIES.

    ``(a) In General.--
            ``(1) Assessment.--The Secretary may assess against a 
        person that commits a serious violation (as defined by the 
        Secretary by regulation) of this Act (including a regulation 
        promulgated or order issued under this Act) a civil penalty for 
        each violation of not more than $100,000.
            ``(2) Separate offenses.--Each violation and each day 
        during which the violation continues shall be considered to be 
        a separate offense.
            ``(3) Notice and opportunity for hearing.--The Secretary 
        shall not assess a civil penalty under this section against a 
        person unless the person is given notice and opportunity for a 
        hearing on the record before the Secretary in accordance with 
        sections 554 and 556 of title 5, United States Code.
            ``(4) Determination of civil penalty amount.--The amount of 
        a civil penalty under this section--
                    ``(A) shall be assessed by the Secretary by written 
                order, taking into account--
                            ``(i) the gravity of the violation;
                            ``(ii) the degree of culpability of the 
                        person;
                            ``(iii) the size and type of the business 
                        of the person; and
                            ``(iv) any history of prior offenses by the 
                        person under this Act; and
                    ``(B) shall be reviewed only in accordance with 
                subsection (b).
    ``(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.--Upon referral of a 
        matter under paragraph (1), the Attorney General shall bring a 
        civil action to recover the amount of the civil penalty in 
        United States district court.
            ``(3) Scope of review.--In a civil action under paragraph 
        (2), the validity and appropriateness of the order of the 
        Secretary assessing the civil penalty shall not be subject to 
        review.
    ``(d) Refusal or Withdrawal of Inspection Pending Payment.--If a 
person fails to pay the amount of a civil penalty after the order 
assessing the civil penalty has become a final order, the Secretary may 
refuse to provide or withdraw inspection under this Act of the person 
until the civil penalty is paid or until the Secretary directs 
otherwise.
    ``(e) Penalties in Lieu of Other Actions.--Nothing in this Act 
requires the Secretary to report for prosecution, or for the 
commencement of an action, any violation of this Act in any case in 
which the Secretary believes that the public interest will be 
adequately served by the assessment of a civil penalty under this 
section.
    ``(f) Remedies Not Exclusive.--The remedies authorized by this 
section shall be in addition to any other remedies that may be 
available.''.
    (b) Criminal Penalties.--Section 12 of the Poultry Products 
Inspection Act (21 U.S.C. 461) is amended--
            (1) in the first sentence of subsection (a)--
                    (A) by striking ``not more than $1,000'' and 
                inserting ``under title 18, United States Code,''; and
                    (B) by striking ``not more than $10,000'' and 
                inserting ``under title 18, United States Code,''; and
            (2) in subsection (c)--
                    (A) in the first sentence, by striking ``not more 
                than $5,000'' and inserting ``under title 18, United 
                States Code,''; and
                    (B) in the second sentence, by striking ``not more 
                than $10,000'' and inserting ``under title 18, United 
                States Code,''.

SEC. 203. FOOD SAFETY ENFORCEMENT FOR EGGS AND EGG PRODUCTS.

    (a) In General.--The Egg Products Inspection Act (21 U.S.C. 1031 et 
seq.) is amended by inserting after section 27 (as added by section 
103) the following:

``SEC. 28. 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 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; or
                    ``(D) in consultation with the Secretary, to 
                provide notice of the finding of the Secretary to all 
                consumers to which the article was, or may have been, 
                distributed.
            ``(2) Mandatory actions.--If the appropriate person 
        referred to in paragraph (1) does not carry out the actions 
        described in that paragraph with respect to an article within 
        the time period and in the manner prescribed by the Secretary, 
        the Secretary shall, by order, require, as the Secretary 
        determines to be necessary, the person--
                    ``(A) to cease immediately distribution of the 
                article; and
                    ``(B) to make immediately the notification 
                described in paragraph (1)(B).
            ``(3) Notice to consumers.--The Secretary shall, as the 
        Secretary determines to be necessary, provide notice of the 
        finding of the Secretary under paragraph (1) to consumers to 
        which the article was, or may have been, distributed.
            ``(4) Nondistribution by notified persons.--A person that 
        transports, stores, distributes, or otherwise handles the 
        article, or to which the article has been transported, sold, 
        distributed, or otherwise handled, and that is notified under 
        paragraph (1)(B) or (2)(B) shall cease immediately distribution 
        of the article.
            ``(5) Availability of records to secretary.--Each 
        appropriate person referred to in paragraph (1) that 
        transported, stored, distributed, or otherwise handled an 
        article shall make available to the Secretary information 
        necessary to carry out this subsection, as determined by the 
        Secretary, regarding--
                    ``(A) persons that transport, store, distribute, or 
                otherwise handle the article; and
                    ``(B) persons to which the article has been 
                transported, sold, distributed, or otherwise handled.
    ``(c) Informal Hearings on Orders.--
            ``(1) In general.--The Secretary shall provide a person 
        subject to an order under subsection (b) with an opportunity 
        for an informal hearing (in accordance with such rules or 
        regulations as the Secretary shall prescribe) on--
                    ``(A) the actions required by the order; and
                    ``(B) any reasons why the article that is the 
                subject of the order should not be recalled.
            ``(2) Timing of hearings.--The Secretary shall hold a 
        hearing under paragraph (1) as soon as practicable, but not 
        later than 2 business days, after the date of issuance of the 
        order.
    ``(d) Post-Hearing Recall Orders.--
            ``(1) Amendment of orders.--If, after providing an 
        opportunity for an informal hearing under subsection (c), the 
        Secretary determines that there is a reasonable probability 
        that human consumption of the article that is the subject of an 
        order under subsection (b) presents a threat to public health, 
        the Secretary may, as the Secretary determines to be 
        necessary--
                    ``(A) amend the order under subsection (b)--
                            ``(i) to require recall of the article or 
                        other appropriate action; and
                            ``(ii) to specify a timetable during which 
                        the recall shall occur;
                    ``(B) require periodic reports to the Secretary 
                describing the progress of the recall; or
                    ``(C) provide notice of the recall to consumers to 
                which the article was, or may have been, distributed.
            ``(2) Vacation of orders.--If, after providing an 
        opportunity for an informal hearing under subsection (c), the 
        Secretary determines that adequate grounds do not exist to 
        continue the actions required by the order, the Secretary shall 
        vacate the order.
    ``(e) Remedies Not Exclusive.--The remedies authorized by this 
section shall be in addition to any other remedies that may be 
available.

``SEC. 29. 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. 30. CIVIL PENALTIES.

    ``(a) In General.--
            ``(1) Assessment.--The Secretary may assess against a 
        person that commits a serious violation (as defined by the 
        Secretary by regulation) of this Act (including a regulation 
        promulgated or order issued under this Act) a civil penalty for 
        each violation of not more than $100,000.
            ``(2) Separate offenses.--Each violation and each day 
        during which the violation continues shall be considered to be 
        a separate offense.
            ``(3) Notice and opportunity for hearing.--The Secretary 
        shall not assess a civil penalty under this section against a 
        person unless the person is given notice and opportunity for a 
        hearing on the record before the Secretary in accordance with 
        sections 554 and 556 of title 5, United States Code.
            ``(4) Determination of civil penalty amount.--The amount of 
        a civil penalty under this section--
                    ``(A) shall be assessed by the Secretary by written 
                order, taking into account--
                            ``(i) the gravity of the violation;
                            ``(ii) the degree of culpability of the 
                        person;
                            ``(iii) the size and type of the business 
                        of the person; and
                            ``(iv) any history of prior offenses by the 
                        person under this Act; and
                    ``(B) shall be reviewed only in accordance with 
                subsection (b).
    ``(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.--Upon referral of a 
        matter under paragraph (1), the Attorney General shall bring a 
        civil action to recover the amount of the civil penalty in 
        United States district court.
            ``(3) Scope of review.--In a civil action under paragraph 
        (2), the validity and appropriateness of the order of the 
        Secretary assessing the civil penalty shall not be subject to 
        review.
    ``(d) Refusal or Withdrawal of Inspection Pending Payment.--If a 
person fails to pay the amount of a civil penalty after the order 
assessing the civil penalty has become a final order, the Secretary may 
refuse to provide or withdraw inspection under this Act of the person 
until the civil penalty is paid or until the Secretary directs 
otherwise.
    ``(e) Penalties in Lieu of Other Actions.--Nothing in this Act 
requires the Secretary to report for prosecution, or for the 
commencement of an action, any violation of this Act in any case in 
which the Secretary believes that the public interest will be 
adequately served by the assessment of a civil penalty under this 
section.
    ``(f) Remedies Not Exclusive.--The remedies authorized by this 
section shall be in addition to any other remedies that may be 
available.''.
    (b) Criminal Penalties.--Section 12 of the Egg Products Inspection 
Act (21 U.S.C. 1041) is amended--
            (1) in subsection (a)--
                    (A) by striking ``of not more than $5,000'' and 
                inserting ``under title 18, United States Code''; and
                    (B) by striking ``of not more than $10,000'' and 
                inserting ``under title 18, United States Code'';
            (2) in subsection (b)--
                    (A) by striking ``not more than $5,000'' and 
                inserting ``under title 18, United States Code''; and
                    (B) by striking ``not more than $10,000'' and 
                inserting ``under title 18, United States Code'';
            (3) by striking subsection (c);
            (4) in subsection (e), by striking ``paragraph (c) of this 
        section 12'' and inserting ``section 30''; and
            (5) by redesignating subsections (d) and (e) as subsections 
        (c) and (d), respectively.

SEC. 204. LIABILITY.

    This subtitle and the amendments made by this subtitle shall not 
affect the liability of any person under any provision of law as in 
effect before the application of this subtitle and the amendments made 
by this subtitle.

                Subtitle B--Food and Drug Administration

SEC. 211. FOOD SAFETY ENFORCEMENT FOR FOOD.

    (a) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 341 et seq.) (as amended by section 111) is amended by 
adding at the end the following:

``SEC. 417. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR 
              MISBRANDED FOOD.

    ``(a) Notice to Secretary of Violation.--
            ``(1) In general.--A person (other than a household 
        consumer or other individual who is the intended consumer of a 
        food) that has reason to believe that any food introduced into 
        or in interstate commerce, or held for sale (whether or not the 
        first sale) after shipment in interstate commerce, may be in 
        violation of this Act shall immediately notify the Secretary of 
        the identity and location of the food.
            ``(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.--If the Secretary determines that 
        food is in violation of the food safety law when introduced 
        into or while in interstate commerce or while held for sale 
        (whether or not the first sale) after shipment in interstate 
        commerce and that there is a reasonable probability that the 
        food, if consumed, would present a threat to public health, as 
        determined by the Secretary, the Secretary shall give the 
        appropriate persons (including the manufacturers, importers, 
        distributors, or retailers of the food) an opportunity to--
                    ``(A) cease distribution of the food;
                    ``(B) notify all persons--
                            ``(i) processing, distributing, or 
                        otherwise handling the food to immediately 
                        cease such activities with respect to the food; 
                        or
                            ``(ii) to which the food has been 
                        distributed, transported, or sold, to 
                        immediately cease distribution of the food;
                    ``(C) recall the food;
                    ``(D) in conjunction with the Secretary, provide 
                notice of the finding of the Secretary--
                            ``(i) to consumers to whom the food was, or 
                        may have been, distributed; and
                            ``(ii) to State and local public health 
                        officials; or
                    ``(E) carry out any combination of the measures 
                described in this paragraph, as determined by the 
                Secretary to be appropriate in the circumstances.
            ``(2) Mandatory actions.--If a person referred to in 
        paragraph (1) refuses to or does not adequately carry out the 
        actions described in that paragraph within the time period and 
        in the manner prescribed by the Secretary, the Secretary 
        shall--
                    ``(A) have authority to control and possess the 
                food, including ordering the shipment of the food from 
                the food establishment to the Secretary--
                            ``(i) at the expense of the food 
                        establishment; or
                            ``(ii) in an emergency (as determined by 
                        the Secretary), at the expense of the 
                        Administration; and
                    ``(B) by order, require, as the Secretary 
                determines to be necessary, the person to immediately--
                            ``(i) cease distribution of the food; and
                            ``(ii) notify all persons--
                                    ``(I) processing, distributing, or 
                                otherwise handling the food to 
                                immediately cease such activities with 
                                respect to the food; or
                                    ``(II) if the food has been 
                                distributed, transported, or sold, to 
                                immediately cease distribution of the 
                                food.
            ``(3) Notification to consumers by secretary.--The 
        Secretary shall, as the Secretary determines to be necessary, 
        provide notice of the finding of the Secretary under paragraph 
        (1)--
                    ``(A) to consumers to whom the food was, or may 
                have been, distributed; and
                    ``(B) to State and local public health officials.
            ``(4) Nondistribution by notified persons.--A person that 
        processes, distributes, or otherwise handles the food, or to 
        which the food has been distributed, transported, or sold, and 
        that is notified under paragraph (1)(B) or (2)(B) shall 
        immediately cease distribution of the food.
            ``(5) Availability of records to secretary.--Each person 
        referred to in paragraph (1) that processed, distributed, or 
        otherwise handled food shall make available to the Secretary 
        information necessary to carry out this subsection, as 
        determined by the Secretary, regarding--
                    ``(A) persons that processed, distributed, or 
                otherwise handled the food; and
                    ``(B) persons to which the food has been 
                transported, sold, distributed, or otherwise handled.
    ``(c) Informal Hearings on Orders.--
            ``(1) In general.--The Secretary shall provide any person 
        subject to an order under subsection (b) with an opportunity 
        for an informal hearing, to be held as soon as practicable but 
        not later than 2 business days after the issuance of the order.
            ``(2) Scope of the hearing.--In a hearing under paragraph 
        (1), the Secretary shall consider the actions required by the 
        order and any reasons why the food that is the subject of the 
        order should not be recalled.
    ``(d) Post Hearing Recall Orders.--
            ``(1) Amendment of order.--If, after providing an 
        opportunity for an informal hearing under subsection (c), the 
        Secretary determines that there is a reasonable probability 
        that the food that is the subject of an order under subsection 
        (b), if consumed, would present a threat to the public health, 
        the Secretary, as the Secretary determines to be necessary, 
        may--
                    ``(A) amend the order to require recall of the food 
                or other appropriate action;
                    ``(B) specify a timetable in which the recall shall 
                occur;
                    ``(C) require periodic reports to the Secretary 
                describing the progress of the recall; and
                    ``(D) provide notice of the recall to consumers to 
                whom the food 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 provided for in this 
section shall be in addition to, and not exclusive of, other remedies 
that may be available.

``SEC. 418. 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 
chapter, refuse to provide or withdraw inspection under this chapter 
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 (within the meaning under section 18 
of the Egg Products Inspection Act (21 U.S.C. 1047)) with the applicant 
or recipient, has committed a willful violation or repeated violations 
of this chapter (including a regulation promulgated under this 
chapter).
    ``(b) Denial or Suspension of Inspection Pending Hearing.--The 
Secretary may deny or suspend inspection under this chapter, pending 
the 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. 419. CIVIL PENALTIES.

    ``(a) In General.--
            ``(1) Assessment.--The Secretary may assess against a 
        person that commits a serious violation (as defined by the 
        Secretary by regulation) of section 417 (including a regulation 
        promulgated or order issued under such 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.--Upon referral of a 
        matter under paragraph (1), 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 chapter of the 
person until the civil penalty is paid or until the Secretary directs 
otherwise.
    ``(e) Penalties in Lieu of Other Actions.--Nothing in this Act 
requires the Secretary to report for prosecution, or for the 
commencement of an action, any violation of this chapter 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) 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:
    ``(hh)(1) The failure to notify the Secretary in violation of 
section 417(a).
    ``(2) The failure to comply with--
            ``(A) an order under section 417(b); or
            ``(B) an amended order issued under section 417(d)(1).''.

SEC. 212. LIABILITY.

    This subtitle and the amendments made by this subtitle shall not 
affect the liability of any person under any provision of law as in 
effect before the application of this subtitle and the amendments made 
by this subtitle.

                        TITLE III--IMPORTED FOOD

SEC. 301. IMPORTED FOOD.

    (a) Certification of Foreign Food Facilities.--Section 415 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) is amended by--
            (1) striking paragraphs (3) and (4) of subsection (a);
            (2) redesignating subsections (b) as subsection (d);
            (3) striking subsection (c);
            (4) inserting after subsection (a) the following:
    ``(b) Certification of Foreign Facilities and Governments.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of the Safe and Secure Food Act of 2005, a foreign 
        facility or foreign government that submits a registration to 
        import food to the United States under this section shall 
        request certification from the Secretary by demonstrating, in a 
        manner determined appropriate by the Secretary, that food 
        produced under the supervision of the foreign facility or 
        foreign government has met standards for food safety, 
        inspection, labeling, and consumer protection that are at least 
        equivalent to the standards applicable to food produced in the 
        United States.
            ``(2) Certification approval.--
                    ``(A) Request by foreign government.--Prior to 
                granting the certification request of a foreign 
                government, the Secretary shall review, audit, and 
                certify the food safety program of a requesting foreign 
                government (including all statutes, regulations, and 
                inspection authority) as at least equivalent to the 
                food safety program in the United States, as 
                demonstrated by the foreign government.
                    ``(B) Request by foreign facility.--Prior to 
                granting the certification request of a foreign 
                facility, the Secretary shall certify, based on an 
                onsite inspection, the food safety programs and 
                procedures of a requesting foreign facility as at least 
                equivalent to the food safety programs and procedures 
                of the United States.
            ``(3) Limitation.--A foreign government or foreign facility 
        approved by the Secretary to import food to the United States 
        under this section shall be certified to export only the 
        approved food products to the United States for a period not to 
        exceed 5 years.
            ``(4) Withdrawal of certification.--The Secretary may 
        withdraw certification of any food from a foreign government or 
        foreign facility--
                    ``(A) if such food is linked to an outbreak of 
                human illness;
                    ``(B) following an investigation by the Secretary 
                that finds that the foreign government programs and 
                procedures or foreign facility is no longer equivalent 
                to the food safety programs and procedures in the 
                United States; or
                    ``(C) following a refusal to allow United States 
                officials to conduct such audits and investigations as 
                may be necessary to fulfill the requirements under this 
                section.
            ``(5) Renewal of certification.--The Secretary shall audit 
        a foreign government or a foreign facility that imports food to 
        the United States every 5 years to ensure the continued 
        compliance with the standards set forth in this section.
            ``(6) Required routine inspection.--The Secretary shall 
        routinely inspect food before it enters the United States to 
        ensure that it is--
                    ``(A) safe for human consumption;
                    ``(B) labeled as required for food produced in the 
                United States; and
                    ``(C) otherwise meets requirements under the food 
                safety law.
            ``(7) Enforcement.--The Secretary--
                    ``(A) may deny importation of food from any foreign 
                government that does not permit United States officials 
                to enter the foreign country to conduct such audits and 
                inspections as may be necessary to fulfill the 
                requirements under this section;
                    ``(B) may deny importation of food from any foreign 
                government or foreign firm that does not consent to an 
                investigation by the Administration when food from that 
                foreign country or foreign firm is linked to a food-
                borne illness outbreak or is otherwise found to be 
                adulterated or mislabeled; and
                    ``(C) is authorized to promulgate rules and 
                regulations to carry out the purposes of this section, 
                including setting terms and conditions for the 
                destruction of products that fail to meet the standards 
                of this Act.
    ``(c) Administrative Requirements.--
            ``(1) Procedure.--
                    ``(A) Domestic facilities.--Upon the receipt of a 
                completed registration described in subsection (a)(1), 
                the Secretary shall notify the domestic facility of the 
                receipt of such registration and assign a registration 
                number to each registered domestic facility.
                    ``(B) Foreign facilities.--Upon the receipt of a 
                completed registration described in subsection (a)(1) 
                and a certification under subsection (b), the Secretary 
                shall notify the foreign facility of the receipt of 
                such registration and certification and assign a 
                registration number to each registered and certified 
                foreign facility.
            ``(2) List.--The Secretary shall maintain an up-to-date 
        list of domestic facilities that are registered and of foreign 
        facilities that are registered and certified under this 
        section. Such list and any registration or certification 
        documents submitted pursuant to this subsection shall not be 
        subject to disclosure under section 552 of title 5, United 
        States Code. Information derived from such list or registration 
        or certification documents shall not be subject to disclosure 
        under section 552 of title 5, United States Code, to the extent 
        that it discloses the identity or location of a specific 
        registered or certified person.''; and
            (5) by adding at the end the following:
    ``(e) Effect on Certain Foreign Facilities.--Foreign facilities 
maintaining a registration under this section on the day before the 
date of enactment of the Safe and Secure Food Act of 2005 shall submit 
a request for certification under subsection (b)(1) not later than 3 
years after the date of enactment of such Act.''.
    (b) In General.--Section 801 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381) is amended by adding at the end the 
following:
    ``(p)(1) The Secretary shall--
            ``(A) conduct an evaluation comparing the laws of the 
        United States with other countries with respect to the 
        inspection and security of food; and
            ``(B) promulgate regulations to--
                    ``(i) develop new methods of detecting contaminated 
                imported food;
                    ``(ii) increase coordination between Federal, 
                State, and local food safety officials with regard to 
                food safety and security;
                    ``(iii) direct food inspectors to check for the 
                safety and security of food during an inspection of a 
                foreign facility; and
                    ``(iv) require persons to implement procedures to 
                prevent the unintentional and intentional contamination 
                of food at foreign facilities covered by this Act.
    ``(2) The regulations promulgated under paragraph (1) shall require 
a person to implement security procedures for the entire foreign 
facility, as determined by the Secretary, including--
            ``(A) developing a security plan that addresses the 
        specific vulnerabilities of the facility;
            ``(B) developing an emergency response plan for the 
        facility;
            ``(C) securing establishment boundaries;
            ``(D) providing guards, alarms, and outside lighting, as 
        necessary;
            ``(E) performing background checks before hiring new 
        personnel;
            ``(F) limiting access to the facility;
            ``(G) accounting for missing stock;
            ``(H) implementing mail-handling procedures; and
            ``(I) such other security procedures as the Secretary 
        determines to be necessary to prevent unintentional or 
        intentional contamination of food.
    ``(3) In this subsection, the term `foreign facility' has the 
meaning given that term in section 415(b)(3).''.
    (c) Adulteration.--Section 402 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 342) is amended by adding at the end the 
following:
    ``(i) If it is food from a domestic or foreign facility (as those 
terms are defined in section 415(b)) that fails to comply with the 
regulations promulgated under section 416 or 801(p).''.
    (d) Conforming Amendment.--Section 801(l)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381(l)(1)) is amended by inserting 
``or that has not received a certification from the Secretary'' after 
``for which a registration has not been submitted to the Secretary''.

             TITLE IV--RISK ASSESSMENT INFORMATION SHARING

SEC. 401. RISK ASSESSMENT INFORMATION SHARING.

    (a) Coordination of Agencies.--The Secretary of Health and Human 
Services shall coordinate with the Secretary of Agriculture, the 
Secretary of Homeland Security, and the Director of the Centers for 
Disease Control and Prevention to--
            (1) assess the security risks to the food supply of the 
        United States; and
            (2) not later than 1 year after the date of enactment of 
        this Act, submit to Congress a report that--
                    (A) describes the assessment under paragraph (1);
                    (B) outlines measures to address any security risks 
                described in such assessment; and
                    (C) describes the costs of addressing such security 
                risks.
    (b) Coordination With Undersecretary for Science and Technology.--
            (1) In general.--The Secretary of Health and Human Services 
        shall coordinate with the Undersecretary of Science and 
        Technology of the Department of Homeland Security with respect 
        to entities awarded grants relating to food safety under 
        section 307(b) of the Homeland Security Act of 2002 (6 U.S.C. 
        187(b)).
            (2) Information sharing.--The Undersecretary of Science and 
        Technology shall grant access to the Secretary of Health and 
        Human Services with respect to information and data gathered at 
        entities awarded grants relating to food safety under section 
        307(b) of the Homeland Security Act of 2002 (6 U.S.C. 187(b)).
                                 <all>