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Title IV — Enforcement

S. 1995 · 116th Congress · Jun 26, 2019 · Lineage

IV Enforcement

Sec. 401 Prohibited acts

It shall be unlawful—
(1)
for a person—
(A)
to manufacture, introduce, deliver for introduction, or receive into interstate commerce any food that is adulterated, misbranded, or otherwise unsafe;
(B)
to adulterate or misbrand any food in interstate commerce;
(C)
to refuse to permit access to a food facility for the inspection and copying of a record as required under section 205(g);
(D)
to fail to establish or maintain any record or to make any report as required under section 205(g);
(E)
to refuse to permit entry to or inspection of a food facility as required under section 205;
(F)
to fail to provide to the Administrator the results of a testing or sampling of a food, equipment, or material in contact with contaminated food under section 205(g)(1)(B);
(G)
to fail to comply with an applicable provision of, or a regulation or order of the Administrator under, section 202, 204, or 208;
(H)
to slaughter an animal that is capable for use in whole or in part as human food at a food facility processing any such food for commerce, except in compliance with the food safety law;
(I)
to fail to comply with a recall or other order under section 402; or
(J)
to otherwise violate the food safety law; and
(2)
for a food facility or foreign food facility to fail to register under section 202, or to operate without a valid registration.

Sec. 402 Mandatory recall authority

(a)
Voluntary procedures— If the Administrator determines that there is a reasonable probability that an article of food (other than infant formula) is adulterated or misbranded and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals, the Administrator shall provide to the owner, operator, or agent in charge of the facility that created, caused, or was otherwise responsible for that article of food an opportunity to cease distribution and recall that article of food in a manner and within a time period determined by the Administrator.
(b)
Prehearing Order To Cease Distribution and Give Notice—
(1)
In general— If the owner, operator, or agent in charge of a facility refuses to, or does not voluntarily, cease distribution or recall an article of food in the manner and within the time period determined by the Administrator under subsection (a), the Administrator may by order require, as the Administrator determines to be necessary—
(A)
that owner, operator, or agent—
(i)
to immediately cease distribution of that article of food; and
(ii)
as applicable, to immediately notify all persons manufacturing, processing, packing, transporting, distributing, receiving, holding, or importing and selling that article of food; and
(B)
any person to which that article of food has been distributed, transported, or sold, to immediately cease distribution of that article of food.
(2)
Required additional information—
(A)
In general— If an article of food covered by a recall order issued under paragraph (1) has been distributed to a warehouse-based, third-party logistics provider without providing such provider sufficient information to know or reasonably determine the precise identity of the article of food covered by a recall order that is in its possession, the notice provided by the owner, operator, or agent of a facility under paragraph (1)(A)(ii) shall include such information as is necessary for the warehouse-based, third-party logistics provider to identify the article of food.
(B)
Rules of construction— Nothing in this paragraph shall be construed—
(i)
to exempt a warehouse-based, third-party logistics provider from the requirements of food safety law; or
(ii)
to exempt a warehouse-based, third-party logistics provider from being the subject of a mandatory recall order.
(3)
Determination to limit areas affected— If the Administrator requires an owner, operator, or agent in charge of the facility to cease distribution under paragraph (1)(A)(i) of an article of food identified under subsection (a), the Administrator may limit the size of the geographic area and the markets affected by such cessation if such limitation would not compromise the public health.
(c)
Hearing on order— The Administrator shall provide the owner, operator, or agent in charge of the facility subject to an order under subsection (b) with an opportunity for an informal hearing, to be held as soon as possible, but not later than 2 days after the issuance of the order, on the actions required by the order and on why the article that is the subject of the order should not be recalled.
(d)
Post-Hearing Recall Order and Modification of Order—
(1)
Amendment of order— If, after providing opportunity for an informal hearing under subsection (c), the Administrator determines that removal of the applicable article of food from commerce is necessary, the Administrator shall, as appropriate—
(A)
amend the order to require recall of such article or other appropriate action;
(B)
specify a timetable in which the recall shall occur;
(C)
require periodic reports to the Administrator describing the progress of the recall; and
(D)
provide notice to consumers to whom such article was, or may have been, distributed.
(2)
Vacating of order— If, after an informal hearing under subsection (c), the Administrator determines that adequate grounds do not exist to continue the actions required by the applicable order, or that such actions should be modified, the Administrator shall vacate the order or modify the order, as appropriate.
(e)
Rule regarding alcoholic beverages— The Administrator shall not initiate a mandatory recall or take any other action under this section with respect to any alcohol beverage until the Administrator has provided the Administrator of the Alcohol and Tobacco Tax and Trade Bureau with a reasonable opportunity to cease distribution and recall the alcohol beverage under the authority of the Administrator of the Alcohol and Tobacco Tax and Trade Bureau.
(f)
Cooperation and consultation— The Administrator shall work with State and local public health officials in carrying out this section, as appropriate.
(g)
Public notification— In conducting a recall under this section, the Administrator shall—
(1)
ensure that a press release is published regarding the recall, as well as alerts and public notices, as appropriate, in order to provide notification—
(A)
of the recall to consumers and retailers to whom the applicable article of food was, or may have been, distributed; and
(B)
that includes, at a minimum—
(i)
the name of the article of food subject to the recall;
(ii)
a description of the risk associated with such article; and
(iii)
to the extent practicable, information for consumers about similar articles of food that are not affected by the recall;
(2)
provide to the public a list of retail consignees receiving products for which there is determined to be a reasonable probability that eating the food will cause serious adverse health consequences or death to humans or animals; and
(3)
if available, publish on the internet website of the Administration an image of the article that is the subject of the press release described in paragraph (1).
(h)
No delegation— The authority conferred by this section to order a recall or vacate a recall order shall not be delegated to any officer or employee other than the Administrator.
(i)
Effect— Nothing in this section shall affect the authority of the Administrator to request or participate in a voluntary recall, or to issue an order to cease distribution or to recall under any other provision of the food safety law or under the Public Health Service Act (42 U.S.C. 201 et seq.).
(j)
Coordinated communication—
(1)
In general— To assist in carrying out the requirements of this subsection, the Administrator shall establish an incident command operation or a similar operation that will operate not later than 24 hours after the initiation of a mandatory recall or the recall of an article of food for which the use of, or exposure to, such article will cause serious adverse health consequences or death to humans or animals.
(2)
Requirements— To reduce the potential for miscommunication during recalls or regarding investigations of a foodborne illness outbreak associated with a food that is subject to a recall, each incident command operation or similar operation under paragraph (1) shall use regular staff and resources of the Administration to—
(A)
ensure timely and coordinated communication within the Administration, including enhanced communication and coordination between different agencies and organizations within the Administration;
(B)
ensure timely and coordinated communication from the Administration, including public statements, throughout the duration of the investigation and related foodborne illness outbreak;
(C)
identify a single point of contact within the Administration for public inquiries regarding any actions by the Administrator related to a recall;
(D)
coordinate with Federal, State, local, and Tribal authorities, as appropriate, that have responsibilities related to the recall of a food or a foodborne illness outbreak associated with a food that is subject to the recall, including notification of the Secretary of Agriculture and the Secretary of Education in the event such recalled food is a commodity intended for use in a child nutrition program (as defined in section 25(b) of the Richard B. Russell National School Lunch Act (42 U.S.C. 1769f(b))); and
(E)
conclude operations at such time as the Administrator determines appropriate.
(3)
Multiple recalls— The Administrator may establish multiple or concurrent incident command operations or similar operations in the event of multiple recalls or foodborne illness outbreaks.
(4)
Fees applicable to all facilities— Fees described in section 743 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–31) for not complying with a recall order are applicable to all food facilities under this Act as if—
(A)
the term responsible party means “owner, operator, or agent in charge of the facility”; and
(B)
references to section 423 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.350l) are references to section 402 of this Act.

Sec. 403 Injunction proceedings

(a)
Jurisdiction— The district courts of the United States, and the United States courts of the territories and possessions of the United States, shall have jurisdiction, for cause shown, to restrain a violation of section 202, 203, 204, 207, or 401 (or a regulation promulgated under that section).
(b)
Trial— In a case in which violation of an injunction or restraining order issued under this section also constitutes a violation of the food safety law, trial shall be by the court or, upon demand of the accused, by a jury.

Sec. 404 Civil and criminal penalties

(a)
Civil sanctions—
(1)
Civil penalty—
(A)
In general— Any person that violates section 401 may be assessed a civil penalty by the Administrator of not more than $250,000 for each violation.
(B)
Separate offense— Each violation described in subparagraph (A) and each day during which that violation continues shall be considered a separate offense.
(2)
Other requirements—
(A)
Written order— The civil penalty described in paragraph (1) shall be assessed by the Administrator by a written order, which shall specify the amount of the penalty and the basis for the penalty under subparagraph (B) considered by the Administrator.
(B)
Amount of penalty— Subject to paragraph (1)(A), the amount of the civil penalty shall be determined by the Administrator, after considering—
(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 the food safety law.
(C)
Review of order— A written order under subparagraph (A) may be reviewed only in accordance with subsection (c).
(b)
Criminal sanctions—
(1)
In general— Except as provided in paragraphs (2) and (3), a person that violates subparagraph (A) or (B) of section 401(1) shall be imprisoned for not more than 1 year, fined not more than $10,000, or both.
(2)
Severe violations— A person that commits a violation described in paragraph (1) after a conviction of that person under this section has become final, or commits such a violation with the intent to defraud or mislead, shall be imprisoned for not more than 3 years, fined not more than $100,000, or both.
(3)
Exception— No person shall be subject to the penalties of this subsection—
(A)
for having received, proffered, or delivered in interstate commerce any food, if the receipt, proffer, or delivery was made in good faith, unless that person refuses to furnish (on request of an officer or employee designated by the Administrator)—
(i)
the name, address, and contact information of the person from whom that person purchased or received the food;
(ii)
copies of all documents relating to the person from whom that person purchased or received the food; and
(iii)
copies of all documents pertaining to the delivery of the food to that person; or
(B)
if that person establishes a guaranty signed by, and containing the name and address of, the person from whom that person received in good faith the food, stating that the food is not adulterated or misbranded within the meaning of this Act.
(c)
Judicial review—
(1)
In general— An order assessing a civil penalty under subsection (a) shall be a final order 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 court of appeals of the United States for the judicial circuit in which that 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 serves a copy of the petition by certified mail to the Administrator.
(2)
Filing of record— Not later than 45 days after the service of a copy of the petition under paragraph (1)(B), the Administrator shall file in the court a certified copy of the administrative record upon which the order was issued.
(3)
Standard of review— The findings of the Administrator relating to the order shall be set aside only if found to be unsupported by substantial evidence on the record as a whole.
(d)
Collection Actions for Failure To Pay—
(1)
In general— If any person fails to pay a civil penalty assessed under subsection (a) after the order assessing the penalty has become a final order, or after the court of appeals described in subsection (c) has entered final judgment in favor of the Administrator, the Administrator shall refer the matter to the Attorney General, who shall institute in a district court of the United States of competent jurisdiction a civil action to recover the amount assessed.
(2)
Limitation on review— In a civil action under paragraph (1), the validity and appropriateness of the order of the Administrator assessing the civil penalty shall not be subject to judicial review.
(e)
Penalties paid into account— The Administrator—
(1)
shall deposit penalties collected under this section in an account in the Treasury; and
(2)
may use the funds in the account, without further appropriation or fiscal year limitation—
(A)
to carry out enforcement activities under food safety law; or
(B)
to provide assistance to States to inspect retail commercial food establishments or other food or firms under the jurisdiction of State food safety programs.
(f)
Discretion of the Administrator To Prosecute— Nothing in this Act requires the Administrator to report for prosecution, or for the commencement of an action, the violation of the food safety law in a case in which the Administrator finds that the public interest will be adequately served by the assessment of a civil penalty under this section.
(g)
Remedies not exclusive— The remedies provided in this section may be in addition to, and not exclusive of, other remedies that may be available.

Sec. 405 Presumption

In any action to enforce the requirements of the food safety law, the connection with interstate commerce required for jurisdiction shall be presumed to exist.

Sec. 406 Whistleblower protection

Section 1013 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 399d) shall apply with respect to any violation of, or any act or omission an employee reasonably believes to be a violation of, any provision of this Act to the same extent and in the same manner as that section applies with respect to a violation of, or any act or omission an employee reasonably believes to be a violation of, any provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

Sec. 407 Administration and enforcement

(a)
In general— For the efficient administration and enforcement of the food safety law, the provisions (including provisions relating to penalties) of sections 6, 8, 9, and 10 of the Federal Trade Commission Act (15 U.S.C. 46, 48, 49, and 50) (except subsections (c) through (h) of section 6 of that Act (15 U.S.C. 46)), relating to the jurisdiction, powers, and duties of the Federal Trade Commission and the Attorney General to administer and enforce that Act, and to the rights and duties of persons with respect to whom the powers are exercised, shall apply to the jurisdiction, powers, and duties of the Administrator and the Attorney General in administering and enforcing the provisions of the food safety law and to the rights and duties of persons with respect to whom the powers are exercised, respectively.
(b)
Inquiries and actions—
(1)
In general— The Administrator, in person or by such agents as the Administrator may designate, may prosecute any inquiry necessary to carry out the duties of the Administrator under the food safety law in any part of the United States.
(2)
Powers— The powers conferred by sections 9 and 10 of the Federal Trade Commission Act (15 U.S.C. 49, 50) on the United States district courts may be exercised for the purposes of this chapter by any district court of the United States of competent jurisdiction.

Sec. 408 Citizen civil actions

(a)
Civil actions— A person may commence a civil action against—
(1)
a person that violates a regulation (including a regulation establishing a performance standard), order, or other action of the Administrator to ensure the safety of food; or
(2)
the Administrator (in his or her capacity as the Administrator), if the Administrator fails to perform an act or duty to ensure the safety of food that is not discretionary under the food safety law.
(b)
Court—
(1)
In general— The action shall be commenced in the district court of the United States for the judicial district in which the defendant resides, is found, or has an agent.
(2)
Jurisdiction— The court described in paragraph (1) shall have jurisdiction, without regard to the amount in controversy or the citizenship of the parties, to enforce a regulation (including a regulation establishing a performance standard), order, or other action of the Administrator, or to order the Administrator to perform the act or duty.
(3)
Damages— The court described in paragraph (1) may—
(A)
award damages, in the amount of damages actually sustained; and
(B)
if the court determines it to be in the interest of justice, award the plaintiff the costs of suit, including reasonable attorney’s fees, reasonable expert witness fees, and penalties.
(c)
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.