I
105TH CONGRESS
1ST SESSION
H. R. 3070
To amend the Federal Food, Drug, and Cosmetic Act to provide for improved
public health and food safety through enhanced enforcement, and for
other purposes.
IN THE HOUSE OF REPRESENTATIVES
NOVEMBER 13, 1997
Mr. PALLONE (for himself, Mr. BROWN of Ohio, Mr. STUPAK, Ms. ESHOO,
and Ms. DELAURO) introduced the following bill; which was referred to
the Committee on Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
provide for improved public health and food safety
through enhanced enforcement, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Food Safety Enforce-
ment Enhancement Act of 1997’’.
SEC. 2. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND
COSMETIC ACT.
(a) IN GENERAL.—The Federal, Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.) is amended by add-
ing after section 413 the following new sections:
‘‘SEC. 414. NOTIFICATION AND RECALL.
‘‘(a) NOTICE TO SECRETARY OF ADULTERATION OR
MISBRANDING.—Any person (other than a household
consumer or other individual who is the intended
consumer of an article of food) that has a reasonable basis
for believing that any article of food introduced into or
in interstate commerce, or held for sale (whether or not
the first sale) after shipment in interstate commerce, may
be adulterated or misbranded shall immediately notify the
Secretary, in such manner and by such means as the Sec-
retary may by regulation prescribe, of the identity and lo-
cation of such article.
‘‘(b) RECALL AND CONSUMER NOTIFICATION.—
‘‘(1) VOLUNTARY
PROCEDURES.—If the Sec-
retary finds, upon such notification or otherwise,
that any article of food is adulterated or misbranded
when introduced into or while in interstate com-
merce or while held for sale (whether or not the first
sale) after shipment in interstate commerce and
there is a reasonable probability that such article, if
consumed, would present a threat to public health,
manner prescribed by the Secretary, the Secretary
shall, by order, require, as the Secretary deems nec-
essary, such person to—
‘‘(A) immediately cease distribution of
such article,
‘‘(B) immediately notify all persons—
‘‘(i) producing, manufacturing, pack-
ing, processing, preparing, treating, pack-
aging, distributing, or holding such article,
or
‘‘(ii) to which such article has been
distributed, transported, or sold,
to immediately cease distribution of such arti-
cle, or
‘‘(C) immediately take the actions specified
in both subparagraphs (A) and (B).
‘‘(3) NOTIFICATION
OF
CONSUMERS
BY
SEC-
RETARY.—The Secretary shall, as the Secretary
deems necessary, provide notice to consumers to
whom such article was, or may have been, distrib-
uted.
‘‘(c) HEARING ON ORDER.—The Secretary shall pro-
vide any person subject to an order under subsection (b)
with an opportunity for a 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.—
‘‘(1) AMENDMENT OF ORDER.—If, after provid-
ing opportunity for a hearing under subsection (c),
the Secretary determines that there is a reasonable
probability that the article that is the subject of an
order under subsection (b), if consumed, presents a
threat to public health, the Secretary, as the Sec-
retary deems necessary, may—
‘‘(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 Sec-
retary describing the progress of the recall, and
‘‘(D) provide notice to consumers to whom
such article was, or may have been, distributed.
‘‘(2) VACATION OF ORDER.—If, after such a
hearing, 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 in this section shall be in addition to and not
exclusive of other remedies that may be available.
‘‘SEC. 418. CIVIL PENALTIES.
‘‘(a) IN GENERAL.—
‘‘(1) ACTS
SUBJECT
TO
PENALTY; PENALTY
AMOUNT.—Any person that commits an act prohib-
ited by section 301 with respect to food may be as-
sessed a civil penalty by the Secretary of not more
than $100,000 for each such act. Each such act and
each day during which such act continues shall be
a separate offense.
‘‘(2) NOTICE AND HEARING.—No penalty shall
be assessed by the Secretary under this section un-
less such person is given notice and opportunity for
a hearing on the record before the Secretary in ac-
cordance with sections 554 and 556 of title 5, Unit-
ed States Code.
‘‘(3) OTHER REQUIREMENTS.—The amount of
such civil penalty shall be assessed by the Secretary
by written order, taking into account the gravity of
the violation, degree of culpability, size and type of
business, and any history of prior offenses; and may
be reviewed only as provided in subsection (b).
‘‘(b) JUDICIAL REVIEW.—An order assessing a civil
penalty under subsection (a) shall be final and conclusive
unless the person files, within 30 days from the effective
date of the order, an application for judicial review in the
Court of Appeals of the United States for the circuit in
which such person resides or has its principal place of
business or in the United States Court of Appeals for the
District of Columbia Circuit by filing a notice of appeal
in such court and by simultaneously sending a copy of
such notice by certified mail to the Secretary. The Sec-
retary shall promptly file in such court a certified copy
of the record upon which such penalty was assessed. The
findings of the Secretary shall be set aside only if found
to be unsupported by substantial evidence on the record
as a whole.
‘‘(c) COLLECTION ACTIONS.—If any person fails to
pay an assessment of a civil penalty after it has become
a final and unappealable order, or after the appropriate
court of appeals has entered final judgment in favor of
the Secretary, the Secretary shall refer the matter to the
Attorney General, who shall institute a civil action to re-
cover the amount assessed in an appropriate district court
of the United States. In such collection action, the validity
and appropriateness of the Secretary’s order imposing the
civil penalty shall not be subject to review.
‘‘(d) PENALTIES PAID INTO TREASURY.—All pen-
alties collected under authority of this section shall be paid
into the Treasury of the United States.
‘‘(e) SECRETARY’S DISCRETION TO PROSECUTE.—
Nothing in this Act shall be construed as requiring the
Secretary to report for prosecution, or for the institution
of libel or injunction proceedings, violations of this Act
whenever the Secretary believes that the public interest
will be adequately served by assessment of civil penalties.
‘‘(f) REMEDIES NOT EXCLUSIVE.—The remedies
provided in this section shall be in addition to and not
exclusive of other remedies that may be available.’’.
(b) CONFORMING AMENDMENT; PROHIBITED ACT.—
Section 301 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 331) is amended by adding at the end the fol-
lowing new subsection:
‘‘(x) The failure or refusal to comply with an order
issued under section 414(b)(2) or 414(d).’’.
SEC. 3. WHISTLEBLOWER PROTECTION.
(a) IN GENERAL.—No employee or other person may
be harassed, prosecuted, held liable, or discriminated
against in any way because that person—
(1) has commenced, caused to be commenced,
or is about to commence a proceeding, testified or is
about to testify at a proceeding, or assisted or par-
ticipated or is about to assist or participate in any
manner in such a proceeding or in any other action
to carry out the purposes, functions, or responsibil-
ities of the Federal Food, Drug, and Cosmetic Act,
or of the Department of Agriculture; or
(2) is refusing to violate or assist in violation
of law, rule, or regulation.
(b) PROCEDURES AND PENALTIES.—The process and
procedures with respect to prohibited discrimination under
subsection (a) shall be governed by the applicable provi-
sions of section 31105 of title 49, United States Code,
unless the party bringing an action under this subsection
chooses alternative dispute resolution procedures such as
mediation or arbitration.
(c) BURDENS OF PROOF.—The legal burdens of proof
with respect to prohibited discrimination under subsection
(a) shall be governed by the applicable provisions of sec-
tions 1214 and 1221 of title 5, United States Code.
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