S. 425 (111th): Food Safety and Tracking Improvement Act

111th Congress, 2009–2010. Text as of Feb 12, 2009 (Introduced).

Status & Summary | PDF | Source: GPO

II

111th CONGRESS

1st Session

S. 425

IN THE SENATE OF THE UNITED STATES

February 12, 2009

introduced the following bill; which was read twice and referred to the Committee on Agriculture, Nutrition, and Forestry

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to provide for the establishment of a traceability system for food, to amend the Federal Meat Inspection Act, the Poultry Products Inspections Act, the Egg Products Inspection Act, and the Federal Food, Drug, and Cosmetic Act to provide for improved public health and food safety through enhanced enforcement, and for other purposes.

1.

Short title; table of contents

(a)

Short title

This Act may be cited as the Food Safety and Tracking Improvement Act.

(b)

Table of contents

The table of contents for this Act is as follows:

Sec. 1. Short title; table of contents.

TITLE I—Traceability of food

Sec. 101. Traceability of food.

TITLE II—Enforcement and recall for meat, poultry, and food

Sec. 201. Food safety enforcement for meat and meat food products.

Sec. 202. Food safety enforcement for poultry and poultry food products.

Sec. 203. Notification, nondistribution, and recall of adulterated or misbranded eggs and egg products.

Sec. 204. Notification, nondistribution, and recall of adulterated or misbranded articles of food.

I

Traceability of food

101.

Traceability of food

The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended—

(1)

in section 301, by inserting at the end the following:

(oo)

The failure to comply with any requirement of section 414A (relating to the traceability of food).

; and

(2)

in chapter IV, by inserting after section 414 the following:

414A.

Traceability of food

(a)

Establishment of system

Not later than 3 years after the date of the enactment of this section, the Secretary shall establish a traceability system described in subsection (b) for all stages of manufacturing, processing, packaging, and distribution of food.

(b)

Description of system

The traceability system required by subsection (a) shall require each article of food shipped in interstate commerce to be identified in a manner that enables the Secretary to retrieve the history, use, and location of the article through a recordkeeping and audit system, a secure, online database, or registered identification.

(c)

Records

(1)

In general

The Secretary may require that each person required to identify an article of food pursuant to subsection (b) maintain accurate records, as prescribed by the Secretary, regarding the purchase, sale, and identification of the article.

(2)

Access

Each person described in paragraph (1) shall, at all reasonable times, on notice by a duly authorized representative of the Secretary, allow the representative to access each place of business of the person to examine and copy the records described in paragraph (1).

(3)

Duration

Each person described in paragraph (1) shall maintain records as required under this subsection for such period of time as the Secretary prescribes.

(d)

False information

No person shall falsify or misrepresent to any other person or to the Secretary, any information as to any location at which any article of food was held.

(e)

Alteration or destruction of records

No person shall, without authorization from the Secretary, alter, detach, or destroy any records or other means of identification prescribed by the Secretary for use in determining the location at which any article of food was held.

(f)

Advisory committee

(1)

In general

In order to assist the Secretary in implementing the traceability system under subsection (a), the Secretary shall convene an advisory committee (referred to in this subsection as the Committee).

(2)

Membership

The Committee shall consist of 13 members appointed by the Secretary which shall include—

(A)

an equitable number of food safety and tracking technology experts, representatives of the food industry, and consumer advocates; and

(B)

officials from the Center for Food Safety and Applied Nutrition and the Office of Regulatory Affairs of the Food and Drug Administration and the Agriculture Marketing Service of the Department of Agriculture.

(3)

Chairperson

The Secretary shall appoint a Chairperson of the Committee.

(4)

Meeting

The Committee shall convene not later than 180 days after the date of enactment of this section and periodically thereafter at the call of the Chairperson.

(5)

Report of Committee

(A)

In general

Not later than 1 year after the date of enactment of this section, the Committee shall submit to the Secretary and the Office of the Commissioner a report that describes the recommendations regarding the most practicable approach to providing for the traceability of food, including the most efficient means of implementing the traceback of contaminated foods.

(B)

Considerations

In developing the report under subparagraph (A), the Committee shall consider the following approaches to providing for the traceability of food:

(i)

A national database or registry operated by the Food and Drug Administration.

(ii)

Electronic records identifying each prior sale, purchase, or trade of the food and its ingredients, and establishing that the food and its ingredients were grown, prepared, handled, manufactured, processed, distributed, shipped, warehoused, imported, and conveyed under conditions that ensure the safety of the food. The records should include an electronic statement with the date of, and the names and addresses of all parties to, each prior sale, purchase, or trade, and any other information as appropriate.

(iii)

Standardized tracking numbers on all shipments. These numbers would identify the country of origin, the unique facility registration number, date of production, and lot number (if applicable).

(iv)

Recall performance standards for each food or commodity type.

(v)

Safeguards for the combining, repacking, or otherwise mixing of items of food, particularly fresh produce.

(vi)

Other approaches that enable the reliable tracking of food and food products.

(g)

Authorization of appropriations

For the purpose of carrying out this section, there is authorized to be appropriated $40,000,000 for the period of fiscal years 2010 through 2012.

.

II

Enforcement and recall for meat, poultry, and food

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—

(1)

by redesignating section 411 (21 U.S.C. 680) as section 414; and

(2)

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

411.

Notification, nondistribution, and recall of adulterated or misbranded articles

(a)

Notification to secretary of violation

(1)

In general

A person (other than a household consumer) that has reason to believe that any carcass, part of a carcass, meat, or meat food product of an amenable species (referred to in this section as an article) transported, stored, distributed, or otherwise handled by the person is adulterated or misbranded shall, as soon as practicable, notify the Secretary of the identity and location of the article.

(2)

Manner of notification

Notification under paragraph (1) shall be made in such manner and by such means as the Secretary may require by regulation.

(b)

Recall and consumer notification

(1)

Voluntary actions

On receiving notification under subsection (a) or by other means, if the Secretary finds that an article is adulterated or misbranded and that there is a reasonable probability that human consumption of the article would present a threat to public health (as determined by the Secretary), the Secretary shall provide all appropriate persons (as determined by the Secretary), that transported, stored, distributed, or otherwise handled the article with an opportunity—

(A)

to cease distribution of the article;

(B)

to notify all persons that transport, store, distribute, or otherwise handle the article, or to which the article has been transported, sold, distributed, or otherwise handled, to cease immediately distribution of the article;

(C)

to recall the article;

(D)

in consultation with the Secretary, to provide notice of the finding of the Secretary to all consumers to which the article was, or may have been, distributed; or

(E)

to notify State and local public health officials.

(2)

Mandatory actions

If the appropriate person referred to in paragraph (1) does not carry out the actions described in that paragraph with respect to an article within the time period and in the manner prescribed by the Secretary, the Secretary—

(A)

shall require the person—

(i)

to immediately cease distribution of the article; and

(ii)

to immediately make the notification described in paragraph (1)(B); and

(B)

may take control or possession of the article.

(3)

Notice to consumers and health officials

The Secretary shall, as the Secretary determines to be necessary, provide notice of the finding of the Secretary under paragraph (1) to consumers to which the article was, or may have been, distributed and to appropriate State and local public health officials.

(4)

Nondistribution by notified persons

A person that transports, stores, distributes, or otherwise handles the article, or to which the article has been transported, sold, distributed, or otherwise handled, and that is notified under paragraph (1)(B) or (2)(B) shall cease immediately distribution of the article.

(5)

Availability of records to secretary

Each appropriate person referred to in paragraph (1) that transported, stored, distributed, or otherwise handled an article shall make available to the Secretary information necessary to carry out this subsection, as determined by the Secretary, regarding—

(A)

persons that transport, store, distribute, or otherwise handle the article; and

(B)

persons to which the article has been transported, sold, distributed, or otherwise handled.

(c)

Informal hearings on orders

(1)

In general

The Secretary shall provide a person subject to an order under subsection (b) with an opportunity for an informal hearing (in accordance with such rules or regulations as the Secretary shall prescribe) on—

(A)

the actions required by the order; and

(B)

any reasons why the article that is the subject of the order should not be recalled.

(2)

Timing of hearings

The Secretary shall hold a hearing under paragraph (1) as soon as practicable, but not later than 2 business days, after the date of issuance of the order.

(d)

Post-hearing recall orders

(1)

Amendment of orders

If, after providing an opportunity for an informal hearing under subsection (c), the Secretary determines that there is a reasonable probability that human consumption of the article that is the subject of an order under subsection (b) presents a threat to public health, the Secretary may, as the Secretary determines to be necessary—

(A)

amend the order under subsection (b)—

(i)

to require recall of the article or other appropriate action; and

(ii)

to specify a timetable during which the recall shall occur;

(B)

require periodic reports to the Secretary describing the progress of the recall;

(C)

provide notice of the recall to consumers to which the article was, or may have been, distributed; or

(D)

take any combination of actions described in subparagraphs (A) through (C).

(2)

Vacation of orders

If, after providing an opportunity for an informal hearing under subsection (c), the Secretary determines that adequate grounds do not exist to continue the actions required by the order, the Secretary shall vacate the order.

(e)

Remedies not exclusive

The remedies authorized by this section shall be in addition to any other remedies that may be available.

412.

Refusal or withdrawal of inspection of establishments

(a)

In general

The Secretary may, for such period, or indefinitely, as the Secretary considers necessary to carry out this Act, refuse to provide or withdraw inspection under title I with respect to an establishment if the Secretary determines, after opportunity for a hearing on the record is provided to the applicant for, or recipient of, inspection, that the applicant or recipient, or any person responsibly connected with the applicant or recipient (within the meaning of section 401), has committed a willful violation or repeated violations of this Act (including a regulation promulgated under this Act).

(b)

Denial or suspension of inspection pending hearing

The Secretary may deny or suspend inspection under title I, pending opportunity for an expedited hearing, with respect to an action under subsection (a), if the Secretary determines that the denial or suspension is in the public interest to protect the health or welfare of consumers or to ensure the effective performance of an official duty under this Act.

(c)

Judicial review

(1)

In general

A determination and order of the Secretary with respect to the refusal or withdrawal of inspection under this section shall be final unless, not later than 30 days after the effective date of the order, the affected applicant for, or recipient of, inspection—

(A)

files a petition for judicial review of the order; and

(B)

simultaneously sends a copy of the petition by certified mail to the Secretary.

(2)

Refusal or withdrawal of inspection pending review

Inspection shall be refused or withdrawn as of the effective date of the order pending any judicial review of the order unless the Secretary directs otherwise.

(3)

Venue; record

Judicial review of the order shall be—

(A)

in—

(i)

the United States court of appeals for the circuit in which the applicant for, or recipient of, inspection resides or has its principal place of business; or

(ii)

the United States Court of Appeals for the District of Columbia Circuit; and

(B)

on the record on which the determination and order are based.

(d)

Remedies not exclusive

The remedies authorized by this section shall be in addition to any other remedies that may be available.

413.

Civil Penalties

(a)

In general

(1)

Assessment

The Secretary may assess against a person that violates section 411 (including a regulation promulgated or order issued under that section) a civil penalty for each violation of not more than $100,000.

(2)

Separate offenses

Each violation and each day during which the violation continues shall be considered to be a separate offense.

(3)

Notice and opportunity for hearing

The Secretary shall not assess a civil penalty under this section against a person unless the person is given notice and opportunity for a hearing on the record before the Secretary in accordance with sections 554 and 556 of title 5, United States Code.

(4)

Determination of civil penalty amount

The amount of a civil penalty under this section—

(A)

shall be assessed by the Secretary by written order, taking into account—

(i)

the gravity of the violation;

(ii)

the degree of culpability of the person;

(iii)

the size and type of the business of the person; and

(iv)

any history of prior offenses by the person under this Act; and

(B)

shall be reviewed only in accordance with subsection (b).

(b)

Judicial review

(1)

In general

An order assessing a civil penalty against a person under subsection (a) shall be final unless the person—

(A)

not later than 30 days after the effective date of the order, files a petition for judicial review of the order in—

(i)

the United States court of appeals for the circuit in which the person resides or has its principal place of business; or

(ii)

the United States Court of Appeals for the District of Columbia Circuit; and

(B)

simultaneously sends a copy of the petition by certified mail to the Secretary.

(2)

Filing of copy of record

The Secretary shall promptly file in the court a certified copy of the record on which the order was issued.

(c)

Collection actions for failure To pay assessment

(1)

Referral to Attorney General

If a person fails to pay a civil penalty assessed under subsection (a) after the order assessing the civil penalty has become a final order, or after the court of appeals has entered final judgment in favor of the Secretary, the Secretary shall refer the matter to the Attorney General.

(2)

Action by Attorney General

The Attorney General shall bring a civil action to recover the amount of the civil penalty in United States district court.

(3)

Scope of review

In a civil action under paragraph (2), the validity and appropriateness of the order of the Secretary assessing the civil penalty shall not be subject to review.

(d)

Refusal or withdrawal of inspection pending payment

If a person fails to pay the amount of a civil penalty after the order assessing the civil penalty has become a final order, the Secretary may refuse to provide or withdraw inspection under title I of the person until the civil penalty is paid or until the Secretary directs otherwise.

(e)

Penalties in lieu of other actions

Nothing in this Act requires the Secretary to report for prosecution, or for the commencement of an action, any violation of section 411 in any case in which the Secretary believes that the public interest will be adequately served by the assessment of a civil penalty under this section.

(f)

Remedies not exclusive

The remedies authorized by this section shall be in addition to any other remedies that may be available.

.

(b)

Conforming amendments

(1)

Section 1 of the Federal Meat Inspection Act (21 U.S.C. 601) is amended by adding at the end the following:

(x)

Person

The term person means any individual, partnership, corporation, association, or other business unit.

.

(2)

The Federal Meat Inspection Act (21 U.S.C. 601 et seq.) is amended—

(A)

by striking person, firm, or corporation each place it appears and inserting person;

(B)

by striking persons, firms, and corporations each place it appears and inserting persons; and

(C)

by striking persons, firms, or corporations each place it appears and inserting persons.

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.) is amended by adding at the end the following:

32.

Notification, nondistribution, and recall of adulterated or misbranded articles

(a)

Notification to secretary of violation

(1)

In general

A person (other than a household consumer) that has reason to believe that any poultry or poultry product (referred to in this section as an article) transported, stored, distributed, or otherwise handled by the person is adulterated or misbranded shall, as soon as practicable, notify the Secretary of the identity and location of the article.

(2)

Manner of notification

Notification under paragraph (1) shall be made in such manner and by such means as the Secretary may require by regulation.

(b)

Recall and consumer notification

(1)

Voluntary actions

On receiving notification under subsection (a) or by other means, if the Secretary finds that an article is adulterated or misbranded and that there is a reasonable probability that human consumption of the article would present a threat to public health (as determined by the Secretary), the Secretary shall provide all appropriate persons (as determined by the Secretary), that transported, stored, distributed, or otherwise handled the article with an opportunity—

(A)

to cease distribution of the article;

(B)

to notify all persons that transport, store, distribute, or otherwise handle the article, or to which the article has been transported, sold, distributed, or otherwise handled, to cease immediately distribution of the article;

(C)

to recall the article;

(D)

in consultation with the Secretary, to provide notice of the finding of the Secretary to all consumers to which the article was, or may have been, distributed; or

(E)

to notify State and local public health officials.

(2)

Mandatory actions

If the appropriate person referred to in paragraph (1) does not carry out the actions described in that paragraph with respect to an article within the time period and in the manner prescribed by the Secretary, the Secretary—

(A)

shall require the person—

(i)

to immediately cease distribution of the article; and

(ii)

to immediately make the notification described in paragraph (1)(B); and

(B)

may take control or possession of the article.

(3)

Notice to consumers and health officials

The Secretary shall, as the Secretary determines to be necessary, provide notice of the finding of the Secretary under paragraph (1) to consumers to which the article was, or may have been, distributed and to appropriate State and local health officials.

(4)

Nondistribution by notified persons

A person that transports, stores, distributes, or otherwise handles the article, or to which the article has been transported, sold, distributed, or otherwise handled, and that is notified under paragraph (1)(B) or (2)(B) shall cease immediately distribution of the article.

(5)

Availability of records to secretary

Each appropriate person referred to in paragraph (1) that transported, stored, distributed, or otherwise handled an article shall make available to the Secretary information necessary to carry out this subsection, as determined by the Secretary, regarding—

(A)

persons that transport, store, distribute, or otherwise handle the article; and

(B)

persons to which the article has been transported, sold, distributed, or otherwise handled.

(c)

Informal hearings on orders

(1)

In general

The Secretary shall provide a person subject to an order under subsection (b) with an opportunity for an informal hearing (in accordance with such rules or regulations as the Secretary shall prescribe) on—

(A)

the actions required by the order; and

(B)

any reasons why the article that is the subject of the order should not be recalled.

(2)

Timing of hearings

The Secretary shall hold a hearing under paragraph (1) as soon as practicable, but not later than 2 business days, after the date of issuance of the order.

(d)

Post-hearing recall orders

(1)

Amendment of orders

If, after providing an opportunity for an informal hearing under subsection (c), the Secretary determines that there is a reasonable probability that human consumption of the article that is the subject of an order under subsection (b) presents a threat to public health, the Secretary may, as the Secretary determines to be necessary—

(A)

amend the order under subsection (b)—

(i)

to require recall of the article or other appropriate action; and

(ii)

to specify a timetable during which the recall shall occur;

(B)

require periodic reports to the Secretary describing the progress of the recall; or

(C)

provide notice of the recall to consumers to which the article was, or may have been, distributed.

(2)

Vacation of orders

If, after providing an opportunity for an informal hearing under subsection (c), the Secretary determines that adequate grounds do not exist to continue the actions required by the order, the Secretary shall vacate the order.

(e)

Remedies not exclusive

The remedies authorized by this section shall be in addition to any other remedies that may be available.

33.

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.

34.

Civil penalties

(a)

In general

(1)

Assessment

The Secretary may assess against a person that violates section 32 (including a regulation promulgated or order issued under that section) a civil penalty for each violation of not more than $100,000.

(2)

Separate offenses

Each violation and each day during which the violation continues shall be considered to be a separate offense.

(3)

Notice and opportunity for hearing

The Secretary shall not assess a civil penalty under this section against a person unless the person is given notice and opportunity for a hearing on the record before the Secretary in accordance with sections 554 and 556 of title 5, United States Code.

(4)

Determination of civil penalty amount

The amount of a civil penalty under this section—

(A)

shall be assessed by the Secretary by written order, taking into account—

(i)

the gravity of the violation;

(ii)

the degree of culpability of the person;

(iii)

the size and type of the business of the person; and

(iv)

any history of prior offenses by the person under this Act; and

(B)

shall be reviewed only in accordance with subsection (b).

(b)

Judicial review

(1)

In general

An order assessing a civil penalty against a person under subsection (a) shall be final unless the person—

(A)

not later than 30 days after the effective date of the order, files a petition for judicial review of the order in—

(i)

the United States court of appeals for the circuit in which the person resides or has its principal place of business; or

(ii)

the United States Court of Appeals for the District of Columbia Circuit; and

(B)

simultaneously sends a copy of the petition by certified mail to the Secretary.

(2)

Filing of copy of record

The Secretary shall promptly file in the court a certified copy of the record on which the order was issued.

(c)

Collection actions for failure To pay assessment

(1)

Referral to Attorney General

If a person fails to pay a civil penalty assessed under subsection (a) after the order assessing the civil penalty has become a final order, or after the court of appeals has entered final judgment in favor of the Secretary, the Secretary shall refer the matter to the Attorney General.

(2)

Action by Attorney General

The Attorney General shall bring a civil action to recover the amount of the civil penalty in United States district court.

(3)

Scope of review

In a civil action under paragraph (2), the validity and appropriateness of the order of the Secretary assessing the civil penalty shall not be subject to review.

(d)

Refusal or withdrawal of inspection pending payment

If a person fails to pay the amount of a civil penalty after the order assessing the civil penalty has become a final order, the Secretary may refuse to provide or withdraw inspection under this Act of the person until the civil penalty is paid or until the Secretary directs otherwise.

(e)

Penalties in lieu of other actions

Nothing in this Act requires the Secretary to report for prosecution, or for the commencement of an action, any violation of section 32 in any case in which the Secretary believes that the public interest will be adequately served by the assessment of a civil penalty under this section.

(f)

Remedies not exclusive

The remedies authorized by this section shall be in addition to any other remedies that may be available.

.

(b)

Conforming amendments

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 32 through 34; and

203.

Notification, nondistribution, and recall of adulterated or misbranded eggs and egg products

The Egg Products Inspection Act is amended by inserting after section 20 (21 U.S.C. 1049) the following:

20A.

Notification, nondistribution, and recall of adulterated or misbranded eggs and egg products

(a)

Notification to Secretary of violation

(1)

In general

A person (other than a household consumer) that has reason to believe that any egg or egg product (referred to in this section as an article) transported, stored, distributed, or otherwise handled by the person is adulterated or misbranded shall, as soon as practicable, notify the Secretary of the identity and location of the article.

(2)

Manner of notification

Notification under paragraph (1) shall be made in such manner and by such means as the Secretary may require by regulation.

(b)

Recall and consumer notification

(1)

Voluntary actions

On receiving notification under subsection (a) or by other means, if the Secretary finds that an article is adulterated or misbranded and that there is a reasonable probability that human consumption of the article would present a threat to public health (as determined by the Secretary), the Secretary shall provide all appropriate persons (as determined by the Secretary), that transported, stored, distributed, or otherwise handled the article with an opportunity—

(A)

to cease distribution of the article;

(B)

to notify all persons that transport, store, distribute, or otherwise handle the article, or to which the article has been transported, sold, distributed, or otherwise handled, to cease immediately distribution of the article;

(C)

to recall the article;

(D)

in consultation with the Secretary, to provide notice of the finding of the Secretary to all consumers to which the article was, or may have been, distributed; or

(E)

to notify State and local public health officials.

(2)

Mandatory actions

If the appropriate person referred to in paragraph (1) does not carry out the actions described in that paragraph with respect to an article within the time period and in the manner prescribed by the Secretary, the Secretary—

(A)

shall require the person—

(i)

to immediately cease distribution of the article; and

(ii)

to immediately make the notification described in paragraph (1)(B); and

(B)

may take control or possession of the article.

(3)

Notice to consumers and health officials

The Secretary shall, as the Secretary determines to be necessary, provide notice of the finding of the Secretary under paragraph (1) to consumers to which the article was, or may have been, distributed and to appropriate State and local health officials.

(4)

Nondistribution by notified persons

A person that transports, stores, distributes, or otherwise handles the article, or to which the article has been transported, sold, distributed, or otherwise handled, and that is notified under paragraph (1)(B) or (2)(B) shall cease immediately distribution of the article.

(5)

Availability of records to secretary

Each appropriate person referred to in paragraph (1) that transported, stored, distributed, or otherwise handled an article shall make available to the Secretary information necessary to carry out this subsection, as determined by the Secretary, regarding—

(A)

persons that transport, store, distribute, or otherwise handle the article; and

(B)

persons to which the article has been transported, sold, distributed, or otherwise handled.

(c)

Informal hearings on orders

(1)

In general

The Secretary shall provide a person subject to an order under subsection (b) with an opportunity for an informal hearing (in accordance with such rules or regulations as the Secretary shall prescribe) on—

(A)

the actions required by the order; and

(B)

any reasons why the article that is the subject of the order should not be recalled.

(2)

Timing of hearings

The Secretary shall hold a hearing under paragraph (1) as soon as practicable, but not later than 2 business days, after the date of issuance of the order.

(d)

Post-hearing recall orders

(1)

Amendment of orders

If, after providing an opportunity for an informal hearing under subsection (c), the Secretary determines that there is a reasonable probability that human consumption of the article that is the subject of an order under subsection (b) presents a threat to public health, the Secretary may, as the Secretary determines to be necessary—

(A)

amend the order under subsection (b)—

(i)

to require recall of the article or other appropriate action; and

(ii)

to specify a timetable during which the recall shall occur;

(B)

require periodic reports to the Secretary describing the progress of the recall; or

(C)

provide notice of the recall to consumers to which the article was, or may have been, distributed.

(2)

Vacation of orders

If, after providing an opportunity for an informal hearing under subsection (c), the Secretary determines that adequate grounds do not exist to continue the actions required by the order, the Secretary shall vacate the order.

(e)

Remedies not exclusive

The remedies authorized by this section shall be in addition to any other remedies that may be available.

20B.

Refusal or withdrawal of inspection of establishments

(a)

In general

The Secretary may, for such period, or indefinitely, as the Secretary considers necessary to carry out this Act, refuse to provide or withdraw inspection under this Act with respect to an establishment if the Secretary determines, after opportunity for a hearing on the record is provided to the applicant for, or recipient of, inspection, that the applicant or recipient, or any person responsibly connected with the applicant or recipient (within the meaning of section 18), has committed a willful violation or repeated violations of this Act (including a regulation promulgated under this Act).

(b)

Denial or suspension of inspection pending hearing

The Secretary may deny or suspend inspection under this Act, pending opportunity for an expedited hearing, with respect to an action under subsection (a), if the Secretary determines that the denial or suspension is in the public interest to protect the health or welfare of consumers or to ensure the effective performance of an official duty under this Act.

(c)

Judicial review

(1)

In general

A determination and order of the Secretary with respect to the refusal or withdrawal of inspection under this section shall be final unless, not later than 30 days after the effective date of the order, the affected applicant for, or recipient of, inspection—

(A)

files a petition for judicial review of the order; and

(B)

simultaneously sends a copy of the petition by certified mail to the Secretary.

(2)

Refusal or withdrawal of inspection pending review

Inspection shall be refused or withdrawn as of the effective date of the order pending any judicial review of the order unless the Secretary directs otherwise.

(3)

Venue; record

Judicial review of the order shall be—

(A)

in—

(i)

the United States court of appeals for the circuit in which the applicant for, or recipient of, inspection resides or has its principal place of business; or

(ii)

the United States Court of Appeals for the District of Columbia Circuit; and

(B)

on the record on which the determination and order are based.

(d)

Remedies not exclusive

The remedies authorized by this section shall be in addition to any other remedies that may be available.

20C.

Civil penalties

(a)

In general

(1)

Assessment

The Secretary may assess against a person that violates section 20A (including a regulation promulgated or order issued under that section) a civil penalty for each violation of not more than $100,000.

(2)

Separate offenses

Each violation and each day during which the violation continues shall be considered to be a separate offense.

(3)

Notice and opportunity for hearing

The Secretary shall not assess a civil penalty under this section against a person unless the person is given notice and opportunity for a hearing on the record before the Secretary in accordance with sections 554 and 556 of title 5, United States Code.

(4)

Determination of civil penalty amount

The amount of a civil penalty under this section—

(A)

shall be assessed by the Secretary by written order, taking into account—

(i)

the gravity of the violation;

(ii)

the degree of culpability of the person;

(iii)

the size and type of the business of the person; and

(iv)

any history of prior offenses by the person under this Act; and

(B)

shall be reviewed only in accordance with subsection (b).

(b)

Judicial review

(1)

In general

An order assessing a civil penalty against a person under subsection (a) shall be final unless the person—

(A)

not later than 30 days after the effective date of the order, files a petition for judicial review of the order in—

(i)

the United States court of appeals for the circuit in which the person resides or has its principal place of business; or

(ii)

the United States Court of Appeals for the District of Columbia Circuit; and

(B)

simultaneously sends a copy of the petition by certified mail to the Secretary.

(2)

Filing of copy of record

The Secretary shall promptly file in the court a certified copy of the record on which the order was issued.

(c)

Collection actions for failure To pay assessment

(1)

Referral to Attorney General

If a person fails to pay a civil penalty assessed under subsection (a) after the order assessing the civil penalty has become a final order, or after the court of appeals has entered final judgment in favor of the Secretary, the Secretary shall refer the matter to the Attorney General.

(2)

Action by Attorney General

The Attorney General shall bring a civil action to recover the amount of the civil penalty in United States district court.

(3)

Scope of review

In a civil action under paragraph (2), the validity and appropriateness of the order of the Secretary assessing the civil penalty shall not be subject to review.

(d)

Refusal or withdrawal of inspection pending payment

If a person fails to pay the amount of a civil penalty after the order assessing the civil penalty has become a final order, the Secretary may refuse to provide or withdraw inspection under this Act of the person until the civil penalty is paid or until the Secretary directs otherwise.

(e)

Penalties in lieu of other actions

Nothing in this Act requires the Secretary to report for prosecution, or for the commencement of an action, any violation of section 20A in any case in which the Secretary believes that the public interest will be adequately served by the assessment of a civil penalty under this section.

(f)

Remedies not exclusive

The remedies authorized by this section shall be in addition to any other remedies that may be available.

.

204.

Notification, nondistribution, and recall of adulterated or misbranded articles of food

(a)

Prohibited acts

Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following:

(pp)
(1)

The failure to notify the Secretary in violation of section 311(a).

(2)

The failure to comply with—

(A)

an order issued under section 311(b) following any hearing requested under section 311(c); or

(B)

an amended order issued under section 311(d)(1).

.

(b)

Notification, nondistribution, and recall of adulterated or misbranded articles of food; civil penalties relating to foods

Chapter III of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331 et seq.) is amended by adding at the end the following:

311.

Notification, nondistribution, and recall of adulterated or misbranded articles of food

(a)

Notification to secretary of violation

(1)

In general

A person (other than a household consumer or other individual who is the intended consumer of an article of food) that has reason to believe that an article of food when introduced into or while in interstate commerce, or while held for sale (regardless of whether the first sale) after shipment in interstate commerce, is adulterated or misbranded in a manner that, if consumed, may result in illness or injury shall, as soon as practicable, notify the Secretary of the identity and location of the article.

(2)

Manner of notification

Notification under paragraph (1) shall be made in such manner and by such means as the Secretary may require by regulation.

(b)

Recall and consumer notification

(1)

Voluntary actions

On receiving notification under subsection (a) or by other means, if the Secretary finds that an article of food when introduced into or while in interstate commerce, or while held for sale (regardless of whether the first sale) after shipment in interstate commerce, is adulterated or misbranded in a manner that, if consumed, may result in illness or injury (as determined by the Secretary), the Secretary shall provide all appropriate persons (including the manufacturer, importer, distributor, or retailer of the article) with an opportunity (as determined by the Secretary)—

(A)

to cease distribution of the article;

(B)

to notify all persons—

(i)

that produce, manufacture, pack, process, prepare, treat, package, distribute, or hold the article, to cease immediately those activities with respect to the article; or

(ii)

to which the article has been distributed, transported, or sold, to cease immediately distribution of the article;

(C)

to recall the article;

(D)

in consultation with the Secretary, to provide notice of the finding of the Secretary to all consumers to which the article was, or may have been, distributed and to appropriate State and local health officials; or

(E)

to notify State and local public health officials.

(2)

Mandatory actions

If the appropriate person referred to in paragraph (1) does not carry out the actions described in that paragraph with respect to an article within the time period and in the manner prescribed by the Secretary, the Secretary—

(A)

shall require the person—

(i)

to immediately cease distribution of the article; and

(ii)

to immediately make the notification described in paragraph (1)(B); and

(B)

may take control or possession of the article.

(3)

Notice to consumers and health officials

The Secretary shall, as the Secretary determines to be necessary, provide notice of the finding of the Secretary under paragraph (1) to consumers to which the article was, or may have been, distributed and to appropriate State and local health officials.

(c)

Hearings on orders

(1)

In general

The Secretary shall provide a person subject to an order under subsection (b) with an opportunity for a hearing on—

(A)

the actions required by the order; and

(B)

any reasons why the article of food that is the subject of the order should not be recalled.

(2)

Timing of hearings

The Secretary shall hold a hearing under paragraph (1) as soon as practicable, but not later than 2 business days, after the date of issuance of the order.

(d)

Post-hearing recall orders

(1)

Amendment of orders

If, after providing an opportunity for a hearing under subsection (c), the Secretary determines that an article of food when introduced into or while in interstate commerce, or while held for sale (regardless of whether the first sale) after shipment in interstate commerce, is adulterated or misbranded in a manner that, if consumed, may result in illness or injury, the Secretary may, as the Secretary determines to be necessary—

(A)

amend the order under subsection (b)—

(i)

to require recall of the article or other appropriate action; and

(ii)

to specify a timetable during which the recall shall occur;

(B)

require periodic reports to the Secretary describing the progress of the recall; or

(C)

provide notice of the recall to consumers to which the article was, or may have been, distributed.

(2)

Vacation of orders

If, after providing an opportunity for a hearing under subsection (c), the Secretary determines that adequate grounds do not exist to continue the actions required by the order, the Secretary shall vacate the order.

(e)

Remedies not exclusive

The remedies authorized by this section shall be in addition to any other remedies that may be available.

312.

Civil penalties relating to foods

(a)

In general

(1)

Assessment

The Secretary may assess against a person that commits an act prohibited by section 301(pp) a civil penalty for each such act of not more than—

(A)

$100,000, in the case of an individual; and

(B)

$500,000, in the case of any other person.

(2)

Separate offenses

Each prohibited act and each day during which the act continues shall be considered to be a separate offense.

(3)

Notice and opportunity for hearing

The Secretary shall not assess a civil penalty under this section against a person unless the person is given notice and opportunity for a hearing on the record before the Secretary in accordance with sections 554 and 556 of title 5, United States Code.

(4)

Determination of civil penalty amount

The amount of a civil penalty under this section—

(A)

shall be assessed by the Secretary by written order, taking into account—

(i)

the gravity of the violation;

(ii)

the degree of culpability of the person;

(iii)

the size and type of the business of the person; and

(iv)

any history of prior offenses by the person; and

(B)

shall be reviewed only in accordance with subsection (b).

(b)

Judicial review

(1)

In general

An order assessing a civil penalty against a person under subsection (a) shall be final unless the person—

(A)

not later than 30 days after the effective date of the order, files a petition for judicial review of the order in—

(i)

the United States court of appeals for the circuit in which the person resides or has its principal place of business; or

(ii)

the United States Court of Appeals for the District of Columbia Circuit; and

(B)

simultaneously sends a copy of the petition by certified mail to the Secretary.

(2)

Filing of copy of record

The Secretary shall promptly file in the court a certified copy of the record on which the order was issued.

(3)

Standard of review

The findings of the Secretary relating to the order shall be set aside only if the findings are found to be unsupported by substantial evidence on the record as a whole.

(c)

Collection actions for failure To pay assessment

(1)

Referral to Attorney General

If a person fails to pay a civil penalty assessed under subsection (a) after the order assessing the civil penalty has become a final order, or after the court of appeals has entered final judgment in favor of the Secretary, the Secretary may refer the matter to the Attorney General.

(2)

Action by Attorney General

The Attorney General shall bring a civil action to recover the amount of the civil penalty in United States district court.

(3)

Scope of review

In a civil action under paragraph (2), the validity and appropriateness of the order of the Secretary assessing the civil penalty shall not be subject to review.

(d)

Penalties deposited in treasury

All amounts collected as civil penalties under this section shall be deposited in the Treasury of the United States.

(e)

Penalties in lieu of other actions

Nothing in this Act requires the Secretary to report for prosecution, or for the commencement of any libel or injunction proceeding, any violation of section 301(pp) 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.

.