(1) improve sanitation and food safety practices
in the processing of food products;
(2) develop improved techniques for the mon-
itoring of food and inspection of food products;
(3) develop efficient, rapid, and sensitive meth-
ods for determining and detecting the presence of
contaminants in food products;
(4) determine the sources of contamination of
food and food products with contaminants; and
(5) develop consumption data with respect to
food products.
(b) CONTRACT AUTHORITY.—The Secretary is au-
thorized to enter into contracts and agreements with any
State, university, other government agencies or other per-
sons to carry out the activities under this section.
TITLE III—ENFORCEMENT
SEC. 301. 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 con-
sumer or other individual who is the intended consumer
of an article of food) that has a reasonable basis for believ-
ing 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 or otherwise in violation of the Consumer
Food Safety Act of 1998 shall immediately notify the Sec-
retary, 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 notification under subsection (a)
or otherwise, that any article of food is adulterated
or misbranded 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 there is a reasonable probability that
such article, if consumed, would present a threat to
public health, as determined by the Secretary, the
Secretary shall provide the appropriate persons (in-
cluding the manufacturers, importers, distributors,
or retailers) with an opportunity to—
‘‘(A) cease distribution of such article;
‘‘(B) 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 imme-
diately cease distribution of such article;
‘‘(C) recall such article;
‘‘(D) provide, in consultation with the Sec-
retary, notice to consumers to whom such arti-
cle was, or may have been, distributed; or
‘‘(E) take any combination of the above
measures, as appropriate in the circumstances.
‘‘(2) PRE-HEARING ORDER TO CEASE DISTRIBU-
TION AND GIVE NOTICE.—If such person refuses to
or does not voluntarily cease distribution, make noti-
fication, recall such article, or provide notice to con-
sumers, as applicable, within the time and in the
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 imme-
diately cease distribution of such article; 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. 415. CIVIL PENALTIES.
‘‘(a) IN GENERAL.—
‘‘(1) ACTS
SUBJECT
TO
PENALTY; PENALTY
AMOUNT.—Any person that commits an act that vio-
lates this Act with respect to food or the Consumer
Food Safety Act of 1998 may be assessed a civil
penalty by the Secretary of not more than $100,000
for each such act. Each such act and each day dur-
ing which such act continues shall be a separate of-
fense.
‘‘(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,
United 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