(B) identify appropriate industry and regu-
latory approaches to minimize hazards in the 
food supply; and 
(C) assess the public health environment 
for emerging diseases, including zoonosis, for 
their risk of appearance in the United States 
food supply. 
(2) COMPONENTS OF ANALYSIS.—The analysis 
under subsection (b)(1) may include— 
(A) a comparison of the safety of commer-
cial processing with the health hazards associ-
ated with food that is harvested for recreational 
or subsistence purposes and prepared non-
commercially; 
(B) a comparison of the safety of food that 
is domestically processed with the health haz-
ards associated with food that is processed out-
side the United States; 
(C) a description of contamination origi-
nating from handling practices that occur prior 
to or after the sale of food to consumers; and 
(D) use of comparative risk assessments. 
SEC. 302. PUBLIC EDUCATION AND ADVISORY SYSTEM. 
(a) PUBLIC EDUCATION.— 
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(1) IN GENERAL.—The Administrator, in co-
operation with private and public organizations, in-
cluding the cooperative extension services and build-
ing on the efforts of appropriate State and local en-
tities, shall establish a national public education pro-
gram on food safety. 
(2) REQUIREMENTS.—The program shall pro-
vide— 
(A) information to the public regarding 
Federal standards and best practices and pro-
motion of public awareness, understanding, and 
acceptance of those standards and practices; 
(B) information for health professionals— 
(i) to improve diagnosis and treatment 
of food-related illness; and 
(ii) to advise individuals at special 
risk for food-related illnesses; and 
(C) such other information or advice to 
consumers and other persons as the Adminis-
trator determines will promote the purposes of 
this Act. 
(b) HEALTH ADVISORIES.—The Administrator, in 
consultation with other Federal departments and agencies 
as the Administrator determines necessary, shall work 
with the States and other appropriate entities— 
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(1) to develop and distribute regional and na-
tional advisories concerning food safety; 
(2) to develop standardized formats for written 
and broadcast advisories; 
(3) to incorporate State and local advisories 
into the national public education program estab-
lished under subsection (a); and 
(4) to present prompt, specific information re-
garding foods found to pose a threat to the public 
health. 
SEC. 303. RESEARCH. 
(a) IN GENERAL.—The Administrator shall conduct 
research to carry out this Act, including studies to— 
(1) improve sanitation and food safety practices 
in the processing of food; 
(2) develop improved techniques to monitor and 
inspect food; 
(3) develop efficient, rapid, and sensitive meth-
ods to detect contaminants in food; 
(4) determine the sources of contamination of 
contaminated food; 
(5) develop food consumption data; 
(6) identify ways that animal production tech-
niques could improve the safety of the food supply; 
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(7) draw upon research and educational pro-
grams that exist at the State and local level; 
(8) utilize the DNA matching system and other 
processes to identify and control pathogens; 
(9) address common and emerging zoonotic dis-
eases; 
(10) develop methods to reduce or destroy 
harmful pathogens before, during, and after proc-
essing; 
(11) 
analyze 
the 
incidence 
of 
antibiotic 
resistence as it pertains to the food supply and de-
velop new methods to reduce the transfer of anti-
biotic resistance to humans; and 
(12) conduct other research that supports the 
purposes of this Act. 
(b) CONTRACT AUTHORITY.—The Administrator may 
enter into contracts and agreements with any State, uni-
versity, Federal Government agency, or person to carry 
out this section. 
TITLE IV—ENFORCEMENT 
SEC. 401. PROHIBITED ACTS. 
It is prohibited— 
(1) to manufacture, introduce, deliver for intro-
duction, or receive into interstate commerce any food 
that is adulterated, misbranded, or otherwise unsafe; 
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(2) to adulterate or misbrand any food in inter-
state commerce; 
(3) for a food establishment or foreign food es-
tablishment to fail to register under section 202, or 
to operate without a valid registration; 
(4) to refuse to permit access to a food estab-
lishment for the inspection and copying of a record 
as required under section 205(h); 
(5) to fail to establish or maintain any record 
or to make any report as required under section 
205(h); 
(6) to refuse to permit entry to or inspection of 
a food establishment as required under section 205; 
(7) to fail to provide to the Administrator the 
results of a testing or sampling of a food, equip-
ment, or material in contact with contaminated food 
under section 205(i); 
(8) to fail to comply with a provision, regula-
tion, or order of the Administrator under section 
202, 203, 204, or 208; 
(9) to slaughter an animal that is capable for 
use in whole or in part as human food at a food es-
tablishment processing any such food for commerce, 
except in compliance with the food safety law; 
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(10) to transfer food in violation of an adminis-
trative detention order under section 402 or to re-
move or alter a required mark or label identifying 
the food as detained; 
(11) to fail to comply with a recall or other 
order under section 403; or 
(12) to otherwise violate the food safety law. 
SEC. 402. FOOD DETENTION, SEIZURE, AND CONDEMNA-
TION. 
(a) ADMINISTRATIVE DETENTION OF FOOD.— 
(1) EXPANDED
AUTHORITY.—The Adminis-
trator shall have authority under section 304 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
334) to administratively detain and seize any food 
that the Administrator has reason to believe is un-
safe, is adulterated or misbranded, or otherwise fails 
to meet the requirements of the food safety law. 
(2) DETENTION AUTHORITY.—If, during an in-
spection conducted in accordance with section 205 or 
208, an officer, employee, or agent of the Adminis-
tration making the inspection has reason to believe 
that a domestic food, imported food, or food offered 
for import is unsafe, is adulterated or misbranded, 
or otherwise fails to meet the requirements of this 
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Act, the officer or employee may order the food de-
tained. 
(3) PERIOD OF DETENTION.— 
(A) IN GENERAL.—A food may be detained 
for a reasonable period, not to exceed 20 days, 
unless a longer period, not to exceed 30 days, 
is necessary for the Administrator to institute a 
seizure action. 
(B) PERISHABLE
FOOD.—The Adminis-
trator shall provide by regulation for procedures 
to institute a seizure action on an expedited 
basis with respect to perishable food. 
(4) SECURITY OF DETAINED FOOD.— 
(A) IN GENERAL.—A detention order— 
(i) may require that the food be la-
beled or marked as detained; and 
(ii) shall require that the food be re-
moved to a secure facility, if appropriate. 
(B) FOOD
SUBJECT
TO
AN
ORDER.—A 
food subject to a detention order shall not be 
transferred by any person from the place at 
which the food is removed, until released by the 
Administrator or until the expiration of the de-
tention period applicable under the order, 
whichever occurs first. 
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(C) DELIVERY OF FOOD.—This subsection 
does not authorize the delivery of a food in ac-
cordance with execution of a bond while the ar-
ticle is subject to the order. 
(b) APPEAL OF DETENTION ORDER.— 
(1) IN GENERAL.—A person who would be enti-
tled to be a claimant for a food subject to a deten-
tion order if the food were seized under section 304 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 334), may appeal the order to the Adminis-
trator. 
(2) ACTION
BY
THE
ADMINISTRATOR.—Not 
later than 5 days after an appeal is filed under para-
graph (1), the Administrator, after providing an op-
portunity for an informal hearing, shall confirm, 
modify, or terminate the order involved. 
(3) FINAL
AGENCY
ACTION.—Confirmation, 
modification, or termination by the Administrator 
under paragraph (2) shall be considered a final 
agency action for purposes of section 702 of title 5, 
United States Code. 
(4) TERMINATION.—The order shall be consid-
ered to be terminated if, after 5 days, the Adminis-
trator has failed— 
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(A) to provide an opportunity for an infor-
mal hearing; or 
(B) to confirm, modify, or terminate the 
order. 
(5) EFFECT OF INSTITUTING COURT ACTION.— 
If the Administrator initiates an action under sec-
tion 302 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 332) or section 304(a) of that Act 
(21 U.S.C. 334(a)), the process for the appeal of the 
detention order shall terminate. 
(c) CONDEMNATION OF FOOD.— 
(1) IN GENERAL.—After confirming a detention 
order, the Administrator may order the food con-
demned. 
(2) DESTRUCTION
OF
FOOD.—Any food con-
demned shall be destroyed under the supervision of 
the Administrator. 
(3) RELEASE OF FOOD.—If the Administrator 
determines that, through reprocessing, relabeling, or 
other action, a detained food can be brought into 
compliance with this Act, the food may be released 
following a determination by the Administrator that 
the relabeling or other action as specified by the Ad-
ministrator has been performed. 
(d) TEMPORARY HOLDS AT PORTS OF ENTRY.— 
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(1) IN GENERAL.—If an officer or qualified em-
ployee of the Administration has reason to believe 
that a food is unsafe, is adulterated or misbranded, 
or otherwise fails to meet the requirements of this 
Act, and the officer or qualified employee is unable 
to inspect, examine, or investigate the food when the 
food is offered for import at a port of entry into the 
United States, the officer or qualified employee shall 
request the Secretary of Homeland Security to hold 
the food at the port of entry for a reasonable period 
of time, not to exceed 24 hours, to enable the Ad-
ministrator to inspect or investigate the food as ap-
propriate. 
(2) REMOVAL TO SECURE FACILITY.—The Ad-
ministrator shall work in coordination with the Sec-
retary of Homeland Security to remove a food held 
in accordance with paragraph (1) to a secure facility 
as appropriate. 
(3) PROHIBITION ON TRANSFER.—During the 
period in which the food is held, the food shall not 
be transferred by any person from the port of entry 
into the United States, or from the secure facility to 
which the food has been removed. 
(4) 
DELIVERY
IN
ACCORDANCE
WITH
A 
BOND.—The delivery of the food in accordance with 
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the execution of a bond while the food is held is not 
authorized. 
(5) PROHIBITION ON REEXPORT.—A food found 
unfit for human or animal consumption shall be pro-
hibited from reexport without further processing to 
remove the contamination and reinspection by the 
Administration. 
SEC. 403. NOTIFICATION AND RECALL. 
(a) NOTICE TO ADMINISTRATOR OF VIOLATION.— 
(1) IN GENERAL.—A person 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 the food safety law shall immediately 
notify the Administrator 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 Administrator may re-
quire by regulation. 
(b) RECALL AND CONSUMER NOTIFICATION.— 
(1) VOLUNTARY
ACTIONS.—If the Adminis-
trator determines that food is in violation of the food 
safety law when introduced into or while in inter-
state commerce or while held for sale (whether or 
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not the first sale) after shipment in interstate com-
merce and that there is a reasonable probability that 
the food, if consumed, would present a threat to 
public health, as determined by the Administrator, 
the Administrator shall give the appropriate persons 
(including the manufacturers, importers, distribu-
tors, or retailers of the food) an opportunity to— 
(A) cease distribution of the food; 
(B) notify all persons— 
(i) processing, distributing, or other-
wise handling the food to immediately 
cease such activities with respect to the 
food; or 
(ii) to which the food has been distrib-
uted, transported, or sold, to immediately 
cease distribution of the food; 
(C) recall the food; 
(D) in conjunction with the Administrator, 
provide notice of the finding of the Adminis-
trator— 
(i) to consumers to whom the food 
was, or may have been, distributed; and 
(ii) to State and local public health of-
ficials; or 
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(E) take any combination of the measures 
described in this paragraph, as determined by 
the Administrator to be appropriate in the cir-
cumstances. 
(2) MANDATORY
ACTIONS.—If a person re-
ferred 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 Administrator, the Administrator 
shall— 
(A) have authority to control and possess 
the food, including ordering the shipment of the 
food from the food establishment to the Admin-
istrator— 
(i) at the expense of the food estab-
lishment; or 
(ii) in an emergency (as determined 
by the Administrator), at the expense of 
the Administration; and 
(B) by order, require, as the Administrator 
determines to be necessary, the person to imme-
diately— 
(i) cease distribution of the food; and 
(ii) notify all persons— 
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(I) processing, distributing, or 
otherwise handling the food to imme-
diately cease such activities with re-
spect to the food; or 
(II) if the food has been distrib-
uted, transported, or sold, to imme-
diately cease distribution of the food. 
(3) NOTIFICATION TO CONSUMERS BY ADMINIS-
TRATOR.—The Administrator shall, as the Adminis-
trator determines to be necessary, provide notice of 
the finding of the Administrator under paragraph 
(1)— 
(A) to consumers to whom the food was, or 
may have been, distributed; and 
(B) to State and local public health offi-
cials. 
(4) NONDISTRIBUTION
BY
NOTIFIED
PER-
SONS.—A person that processes, distributes, or oth-
erwise 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 im-
mediately cease distribution of the food. 
(5) AVAILABILITY
OF
RECORDS
TO
ADMINIS-
TRATOR.—Each person referred to in paragraph (1) 
that processed, distributed, or otherwise handled 
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food shall make available to the Administrator infor-
mation necessary to carry out this subsection, as de-
termined by the Administrator, 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 han-
dled. 
(c) INFORMAL HEARINGS ON ORDERS.— 
(1) IN GENERAL.—The Administrator shall pro-
vide 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 Administrator shall con-
sider the actions required by the order and any rea-
sons 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 pro-
viding an opportunity for an informal hearing under 
subsection (c), the Administrator determines that 
there is a reasonable probability that the food that 
is the subject of an order under subsection (b), if 
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consumed, would present a threat to the public 
health, the Administrator, as the Administrator de-
termines 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 Admin-
istrator describing the progress of the recall; 
and 
(D) provide notice of the recall to con-
sumers to whom the food was, or may have 
been, distributed. 
(2) VACATION OF ORDERS.—If, after providing 
an opportunity for an informal hearing under sub-
section (c), the Administrator determines that ade-
quate grounds do not exist to continue the actions 
required by the order, the Administrator shall vacate 
the order. 
(e) REMEDIES NOT EXCLUSIVE.—The remedies pro-
vided in this section shall be in addition to, and not exclu-
sive of, other remedies that may be available. 
SEC. 404. INJUNCTION PROCEEDINGS. 
(a) JURISDICTION.—The district courts of the United 
States, and the United States courts of the territories and 
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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 injunc-
tion 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. 405. CIVIL AND CRIMINAL PENALTIES. 
(a) CIVIL SANCTIONS.— 
(1) CIVIL PENALTY.— 
(A) IN GENERAL.—Any person that com-
mits an act that violates the food safety law (in-
cluding a regulation promulgated or order 
issued under a Federal food safety law) may be 
assessed a civil penalty by the Administrator of 
not more than $10,000 for each such act. 
(B) SEPARATE
OFFENSE.—Each act de-
scribed in subparagraph (A) and each day dur-
ing which that act 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 
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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 pen-
alty 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.—The order may 
be reviewed only in accordance with subsection 
(c). 
(b) CRIMINAL SANCTIONS.— 
(1) IN GENERAL.—Except as provided in para-
graphs (2) and (3), a person that knowingly pro-
duces or introduces into commerce food that is un-
safe or otherwise adulterated or misbranded shall be 
imprisoned for not more than 1 year or fined not 
more than $10,000, or both. 
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(2) SEVERE VIOLATIONS.—A person that com-
mits a violation described in paragraph (1) after a 
conviction of that person under this section has be-
come final, or commits such a violation with the in-
tent to defraud or mislead, shall be imprisoned for 
not more than 3 years or 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 deliv-
ered in interstate commerce any food, if the re-
ceipt, 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 in-
formation 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 pur-
chased or received the food; and 
(iii) copies of all documents pertaining 
to the delivery of the food to that person; 
or 
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(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 mean-
ing 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 effec-
tive date of the order, files a petition for judi-
cial review of the order in the United States 
court of appeals for the circuit in which that 
person resides or has its principal place of busi-
ness or the United States Court of Appeals for 
the District of Columbia; and 
(B) simultaneously serves a copy of the pe-
tition 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. 
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(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 
(b) has entered final judgment in favor of the Ad-
ministrator, the Administrator shall refer the matter 
to the Attorney General, who shall institute in a 
United States district court of competent jurisdic-
tion a civil action to recover the amount assessed. 
(2) LIMITATION ON REVIEW.—In a civil action 
under paragraph (1), the validity and appropriate-
ness of the order of the Administrator assessing the 
civil penalty shall not be subject to judicial review. 
(e) PENALTIES PAID INTO ACCOUNT.—The Adminis-
trator— 
(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— 
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(A) to carry out enforcement activities 
under food safety law; or 
(B) to provide assistance to States to in-
spect retail commercial food establishments or 
other food or firms under the jurisdiction of 
State food safety programs. 
(f) DISCRETION OF THE ADMINISTRATOR TO PROS-
ECUTE.—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 pro-
vided in this section may be in addition to, and not exclu-
sive of, other remedies that may be available. 
SEC. 406. PRESUMPTION. 
In any action to enforce the requirements of the food 
safety law, the connection with interstate commerce re-
quired for jurisdiction shall be presumed to exist. 
SEC. 407. WHISTLEBLOWER PROTECTION. 
(a) IN GENERAL.—No Federal employee, employee of 
a Federal contractor or subcontractor, or any individual 
employed by a company (referred to in this section as a 
‘‘covered individual’’), may be discharged, demoted, sus-
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pended, threatened, harassed, or in any other manner dis-
criminated against, because of any lawful act done by the 
covered individual to— 
(1) provide information, cause information to be 
provided, or otherwise assist in an investigation re-
garding any conduct that the covered individual rea-
sonably believes constitutes a violation of any law, 
rule, or regulation, or that the covered individual 
reasonably believes constitutes a threat to the public 
health, when the information or assistance is pro-
vided to, or the investigation is conducted by— 
(A) a Federal regulatory or law enforce-
ment agency; 
(B) a Member or committee of Congress; 
or 
(C) a person with supervisory authority 
over the covered individual (or such other indi-
vidual who has the authority to investigate, dis-
cover, or terminate misconduct); 
(2) file, cause to be filed, testify, participate in, 
or otherwise assist in a proceeding or action filed or 
about to be filed relating to a violation of any law, 
rule, or regulation; or 
(3) refused to violate or assist in the violation 
of any law, rule, or regulation. 
VerDate Aug 31 2005 
03:44 Feb 24, 2007
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