S. 1534 (109th): Safe and Secure Food Act of 2005

109th Congress, 2005–2006. Text as of Jul 28, 2005 (Introduced).

Status & Summary | PDF | Source: GPO

II

109th CONGRESS

1st Session

S. 1534

IN THE SENATE OF THE UNITED STATES

July 28, 2005

(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.

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.

I

Food Security

A

Department of Agriculture

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:

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).

.

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:

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.

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:

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).

.

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.

.

B

Food and Drug Administration

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:

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).

.

C

Inspector Training

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.

II

Recall Authority

A

Department of Agriculture

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:

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.

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.

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.

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:

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.

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.

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,.

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:

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.

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.

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.

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.

B

Food and Drug Administration

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:

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.

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.

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).

.

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.

III

Imported Food

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.

IV

Risk Assessment Information Sharing

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)).