‘‘(C) PILOT PROJECTS.—Before issuing a 
proposed regulation under this subsection, the 
Secretary shall conduct 1 or more pilot projects 
in coordination with 1 or more sectors of the 
food industry to explore and evaluate tracing 
systems for food. The Secretary shall coordinate 
with the Secretary of Agriculture in conducting 
pilot projects with respect to farms under this 
subsection. 
‘‘(3) REGULATION.— 
‘‘(A) IN GENERAL.—Taking into account 
information obtained through information gath-
ering under paragraph (2), the Secretary shall 
issue regulations establishing a tracing system 
that enables the Secretary to identify each per-
son who grows, produces, manufactures, proc-
esses, packs, transports, holds, or sells such 
food in as short a timeframe as practicable but 
no longer than 2 business days. 
‘‘(B) SCOPE OF REGULATION.—The Sec-
retary may include in the regulations estab-
lishing a tracing system— 
‘‘(i) the establishment and mainte-
nance of lot numbers;
‘‘(ii) a standardized format for pedi-
gree information; and 
‘‘(iii) the use of a common nomen-
clature for food. 
‘‘(C) COORDINATION REGARDING FARM IM-
PACT.—In issuing regulations under this para-
graph that will impact farms, the Secretary— 
‘‘(i) shall coordinate with the Sec-
retary of Agriculture; and 
‘‘(ii) take into account the nature of 
the impact of the regulations on farms. 
‘‘(4) EXEMPTIONS AND LIMITATIONS.— 
‘‘(A) DIRECT SALES BY FARMS.—Food is 
exempt from the requirements of this sub-
section if such food is— 
‘‘(i) produced on a farm; and 
‘‘(ii) sold by the owner, operator, or 
agent in charge of such farm directly to a 
consumer or to a restaurant or grocery 
store. 
‘‘(B) FISHING VESSELS.—Food is exempt 
from the requirements of this subsection if such 
food is produced through the use of a fishing 
vessel as defined in section 3(18) of the Magnu-
son-Stevens Fishery Conservation and Manage-
ment Act until such time as the food is sold by 
the owner, operator, or agent in charge of such 
fishing vessel. 
‘‘(C) GRAINS
AND
SIMILARLY
HANDLED 
COMMODITIES.— 
‘‘(i) LIMITATION
ON
EXTENT
OF 
TRACING.—In addition to the exemption 
under subparagraph (A), any tracing sys-
tem established under this subsection with 
regard to any grain or similarly handled 
commodity shall be limited to enabling the 
Secretary to identify persons who received, 
processed, packed, transported, distributed, 
held, or sold the grain or similarly handled 
commodity from the initial warehouse op-
erator that held the grain or similarly han-
dled commodity for any period of time to 
the ultimate consumer. 
‘‘(ii) DEFINITIONS.—In this subpara-
graph: 
‘‘(I) The term ‘grain or similarly 
handled commodity’ means wheat, 
corn, grain sorghum, barley, oats, 
rice, wild rice, rye, soybeans, legumes, 
sugar cane, sugar beets, sunflower
seed, 
rapeseed, 
canola, 
safflower, 
flaxseed, mustard seed, crambe, ses-
ame seed, camelina, cottonseed, cocoa 
beans, grass hay, and honey. The 
term may include any other com-
modity as determined by the Sec-
retary in coordination with the Sec-
retary of Agriculture. 
‘‘(II) The term ‘warehouse oper-
ator’ has the meaning given that term 
in section 2 of the United States 
Warehouse Act (7 U.S.C. 241), except 
that the term also includes any person 
or entity that handles or stores agri-
cultural products for other persons or 
entities or, in the case of a coopera-
tive, handles or stores agricultural 
products for its members, as deter-
mined by the Secretary in coordina-
tion with the Secretary of Agriculture. 
‘‘(D) EXEMPTION OF OTHER FOODS.—The 
Secretary may by notice in the Federal Register 
exempt a food or a type of facility, farm, or res-
taurant from, or modify the requirements with 
respect to, the requirements of this subsection
if the Secretary determines that a tracing sys-
tem for such food or type of facility, farm, or 
restaurant is not necessary to protect the public 
health. 
‘‘(E) RECORDKEEPING
REGARDING
PRE-
VIOUS
SOURCES
AND
SUBSEQUENT
RECIPI-
ENTS.—For a food or person covered by a limi-
tation or exemption under subparagraph (B), 
(C), or (D), the Secretary shall require each 
person who produces, receives, manufactures, 
processes, packs, transports, distributes, or 
holds such food to maintain records to identify 
the immediate previous sources of such food 
and its ingredients and the immediate subse-
quent recipients of such food. 
‘‘(F) RECORDKEEPING
BY
RESTAURANTS 
AND GROCERY STORES.—For a food covered by 
an exemption under subparagraph (A), res-
taurants and grocery stores shall keep records 
documenting the farm that was the source of 
the food. 
‘‘(G) RECORDKEEPING BY FARMS.—For a 
food covered by an exemption under subpara-
graph (A), farms shall keep records, in elec-
tronic or non-electronic format, for at least 6
months documenting the restaurant or grocery 
store to which the food was sold.’’. 
SEC. 108. REINSPECTION AND FOOD RECALL FEES APPLI-
CABLE TO FACILITIES. 
(a) IN GENERAL.—Part 6 of subchapter C of chapter 
VII (21 U.S.C. 371 et seq.), as added by section 101(c), 
is amended by adding at the end the following: 
‘‘SEC. 743A. REINSPECTION AND FOOD RECALL FEES APPLI-
CABLE TO FACILITIES. 
‘‘(a) IN GENERAL.—The Secretary shall assess and 
collect fees from each entity in a fiscal year— 
‘‘(1) that— 
‘‘(A) during such fiscal year commits a vio-
lation of any requirement of this Act relating to 
food, including any such requirement relating to 
good manufacturing practices; and 
‘‘(B) because of such violation, undergoes 
additional inspection by the Food and Drug Ad-
ministration; or 
‘‘(2) during such fiscal year is subject to a food 
recall. 
‘‘(b) AMOUNT OF FEES.—The Secretary shall set the 
amount of the fees under this section to fully cover the 
costs of—
‘‘(1) in the case of fees collected under sub-
section (a)(1), conducting the additional inspections 
referred to in such subsection; and 
‘‘(2) in the case of fees collected under sub-
section (a)(2), conducting food recall activities, in-
cluding technical assistance, follow-up effectiveness 
checks, and public notifications, during the fiscal 
year involved. 
‘‘(c) CREDITING AND AVAILABILITY OF FEES.— 
‘‘(1) IN GENERAL.—Fees authorized under sub-
section (a) shall be collected and available for obliga-
tion only to the extent and in the amount provided 
in advance in appropriations Acts. Such fees are au-
thorized to remain available until expended. Such 
sums as may be necessary may be transferred from 
the Food and Drug Administration salaries and ex-
penses appropriation account without fiscal year lim-
itation to such appropriation account for salaries 
and expenses with such fiscal year limitation. 
‘‘(2) 
COLLECTIONS
AND
APPROPRIATIONS 
ACTS.—The fees authorized by this section— 
‘‘(A) shall be retained in each fiscal year in 
an amount not to exceed the amount specified 
in appropriation Acts, or otherwise made avail-
able for obligation, for such fiscal year; and
‘‘(B) shall only be collected and available 
to defray the costs referred to in subsection (b). 
‘‘(3) AUTHORIZATION
OF
APPROPRIATIONS.— 
For each of fiscal years 2010 through 2014, there 
are authorized to be appropriated for fees under this 
section such sums as may be necessary. 
‘‘(d) WAIVER.—The Secretary shall waive and, if ap-
plicable, refund the amount of any fee collected under this 
section from an entity as a result of a food recall that 
the Secretary determines was inappropriately ordered.’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply to additional inspections and 
food recall activities occurring after the date of the enact-
ment of this Act. 
SEC. 109. CERTIFICATION AND ACCREDITATION. 
(a) MISBRANDING.— 
(1) IN
GENERAL.—Section 403 (21 U.S.C. 
343), as amended by section 101(a), is amended by 
adding at the end the following: 
‘‘(aa) If it is part of a shipment offered for import 
into the United States and such shipment is in violation 
of section 801(q) (requiring a certification of compliance 
for certain food shipments).’’. 
(2) EFFECTIVE DATE.—The amendment made 
by paragraph (1) shall apply to shipments offered
for import on or after the date that is 3 years after 
the date of the enactment of this Act. 
(b) CERTIFICATION
OF
COMPLIANCE
FOR
IM-
PORTS.—Chapter VIII (21 U.S.C. 381 et seq.) is amend-
ed— 
(1) in section 801(a), as amended by section 
107(b), by inserting after the third sentence the fol-
lowing: ‘‘If such article is food being imported or of-
fered for import into the United States and is not 
in compliance with the requirement of subsection (q) 
(relating to certifications of compliance with this 
Act), then such article shall be refused admission.’’; 
(2) in the second sentence of section 801(b), by 
striking ‘‘the fourth sentence’’ and inserting ‘‘the 
fifth sentence’’; and 
(3) by adding at the end of section 801 the fol-
lowing: 
‘‘(q) CERTIFICATIONS CONCERNING IMPORTED ARTI-
CLES.— 
‘‘(1) IN GENERAL.— 
‘‘(A) REQUIREMENT.—The Secretary may 
require, as an additional condition of granting 
admission to an article of food being imported 
or offered for import into the United States, 
that a qualified certifying entity provide a cer-
tification that the article complies with require-
ments of this Act as specified by the Secretary 
if— 
‘‘(i) for food imported from a par-
ticular country, territory, or region, the 
Secretary finds, based on scientific, risk- 
based evidence, that the government con-
trols in such country, territory, or region 
are inadequate to ensure that the article is 
safe and that certification would assist the 
Secretary in determining whether to refuse 
to admit such article under subsection (a); 
‘‘(ii) for a type of food for which there 
is scientific evidence that there is a par-
ticular risk associated with the food that 
presents a threat of serious adverse health 
consequences or death, the Secretary finds 
that certification would assist the Sec-
retary in determining whether to refuse to 
admit such article under subsection (a); or 
‘‘(iii) for an article imported from a 
particular country or territory, there is an 
agreement between the Secretary and the 
government of such country or territory 
providing for such certification.
‘‘(B) FORM OF CERTIFICATION.—A certifi-
cation under subparagraph (A) may take the 
form of a statement that the article or the facil-
ity or farm that manufactured, processed, 
packed, held, grew, harvested, sorted, or trans-
ported the article, as the case may be, complies 
with requirements of this Act as specified by 
the Secretary, or any other form as the Sec-
retary may specify, including a listing of cer-
tified facilities or other entities. The Secretary 
may require that the certification include addi-
tional information regarding compliance. 
‘‘(C) 
ADEQUATE
GOVERNMENT
CON-
TROLS.— 
‘‘(i) PROCESS.—Before requiring a 
certification under clause (ii) of subpara-
graph (A) with respect to a food, the Sec-
retary shall establish a process by which a 
country or territory may demonstrate that 
its government controls are adequate to 
ensure that such food exported from its 
territory to the United States is safe. 
‘‘(ii) 
DEMONSTRATION.—The 
Sec-
retary shall not require a certification 
under clause (ii) of subparagraph (A) for
a food exported from a country or terri-
tory, if that country or territory has dem-
onstrated, pursuant to the process estab-
lished by the Secretary under clause (i), 
that its government controls are adequate 
to ensure that such food exported from its 
territory to the United States is safe. 
‘‘(D) NOTICE OF CANCELLATION OR SUS-
PENSION OF CERTIFICATION.—As a condition 
on acceptance of certifications from a qualified 
certifying entity, the Secretary shall require the 
qualified certifying entity to notify the Sec-
retary whenever the qualified certifying entity 
cancels or suspends the certification of any fa-
cility or other entity included in a listing under 
subparagraph (B). 
‘‘(E) CONSISTENCY WITH INTERNATIONAL 
OBLIGATIONS.—The Secretary shall apply this 
paragraph consistently with United States obli-
gations under international agreements. 
‘‘(2) QUALIFIED
CERTIFYING
ENTITY.—For 
purposes of this subsection, the term ‘qualified certi-
fying entity’ means— 
‘‘(A) an agency or a representative of the 
government of the country from which the arti-
cle originated, as designated by such govern-
ment or the Secretary; or 
‘‘(B) an individual or entity determined by 
the Secretary or an accredited body recognized 
by the Secretary to be qualified to provide a 
certification under paragraph (1). 
‘‘(3) NO CONFLICTS OF INTEREST.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
issue regulations to ensure that any qualified 
certifying entity and its auditors are free from 
conflicts of interest. In issuing these regula-
tions, the Secretary may rely on or incorporate 
international certification standards. 
‘‘(B) 
REGULATIONS.—Such 
regulations 
shall require that— 
‘‘(i) the qualified certifying entity 
shall have a committee or management 
structure for safeguarding impartiality; 
‘‘(ii) conflict of interest policies for a 
qualified certifying entity and auditors act-
ing for the qualified certifying entity shall 
be written; 
‘‘(iii) the qualified certifying entity 
shall not be owned, operated, or controlled 
by a producer, manufacturer, processor,
packer, holder, supplier, or vendor of any 
article of the type it certifies; 
‘‘(iv) the qualified certifying entity 
shall not have any ownership or financial 
interest in any product, producer, manu-
facturer, processor, packer, holder, supplier 
or vendor of the type it certifies; 
‘‘(v) no auditor acting for the quali-
fied certifying entity (or spouse or minor 
children) shall have any significant owner-
ship or other financial interest regarding 
any product of the type it certifies; 
‘‘(vi) the qualified certifying entity 
shall— 
‘‘(I) obtain and maintain annual 
declarations from all personnel who 
may be directly involved in the per-
formance of audits as to whether they 
do or do not have direct financial in-
terests in any producer, manufacturer, 
processor, packer, holder, supplier, or 
vendor of foods, and a list of any such 
companies in which they do have fi-
nancial interests or by which they 
were employed in the past year; and
‘‘(II) when an auditor is assigned 
to audit a facility, require that indi-
vidual to affirm that he or she has no 
financial interest in the company that 
owns or operates that facility and was 
not employed by that facility in the 
previous year; 
‘‘(vii) neither the qualified certifying 
entity nor any of its auditors acting for the 
qualified certifying entity shall participate 
in the production, manufacture, processing, 
packing, holding, promotion, or sale of any 
product of the type it certifies; 
‘‘(viii) neither the qualified certifying 
entity nor any of its auditors shall provide 
consultative services to any facility cer-
tified by the qualified certifying entity, or 
the owner, operator, or agent in charge of 
such a facility, unless the qualified certi-
fying entity has procedures in place, ap-
proved by the Secretary, to ensure separa-
tion of functions between auditors pro-
viding consultative services and auditors 
providing certification services under this 
subsection;
‘‘(ix) no auditors acting for the quali-
fied certifying entity shall participate in an 
audit of a facility they were employed by 
within the last 12 months; 
‘‘(x) fees charged or accepted shall 
not be contingent or based upon the report 
made by the qualified certifying entity or 
any personnel involved in the audit proc-
ess; 
‘‘(xi) neither the qualified certifying 
entity nor any of its auditors shall accept 
anything of value from anyone in connec-
tion with the facility being audited other 
than the audit fee; 
‘‘(xii) the qualified certifying entity 
shall not be owned, operated, or controlled 
by a trade association whose member com-
panies operate facilities that it certifies; 
‘‘(xiii) the qualified certifying entity 
and its auditors shall be free from any 
other conflicts of interest that threaten im-
partiality; 
‘‘(xiv) the qualified certifying entity 
and its auditors shall sign a statement at-
testing to compliance with the conflict of
interests requirements under this para-
graph; and 
‘‘(xv) the qualified certifying entity 
shall ensure that any subcontractors that 
might be used (such as laboratories and 
sampling services) provide similar assur-
ances, except that it shall not be a viola-
tion of this subsection to the extent such 
subcontractors perform additional nutri-
tional testing services unrelated to the test-
ing under this subsection. 
‘‘(C) DEFINITIONS.—In this paragraph: 
‘‘(i) The term ‘anything of value’ in-
cludes gifts, gratuities, reimbursement of 
non-audit-related expenses, entertainment, 
loans, or any other form of compensation 
in cash or in kind. 
‘‘(ii) The term ‘direct financial inter-
est’ does not include any ownership of mu-
tual funds that have a financial interest in 
a company. 
‘‘(4) RENEWAL
AND
REFUSAL
OF
CERTIFI-
CATIONS.—The Secretary shall— 
‘‘(A) require that, to the extent applicable, 
any certification provided by a qualified certi-
the electronic submission of certifications under this 
subsection. 
‘‘(7) NO
LIMIT
ON
AUTHORITY.—This sub-
section shall not be construed to limit the authority 
of the Secretary to conduct random inspections of 
imported articles or facilities of importers, issue im-
port alerts for detention without physical examina-
tion, require submission to the Secretary of docu-
mentation or other information about an article im-
ported or offered for import, or to take such other 
steps as the Secretary deems appropriate to deter-
mine the admissibility of imported articles.’’. 
SEC. 110. TESTING BY ACCREDITED LABORATORIES. 
(a) PROHIBITED ACT.—Section 301 (21 U.S.C. 331) 
is amended by adding at the end the following: 
‘‘(uu) The violation of any requirement of section 714 
(relating to testing by accredited laboratories).’’. 
(b) LABORATORY ACCREDITATION.—Subchapter A of 
chapter VII (21 U.S.C. 371 et seq.) is amended by adding 
at the end the following: 
‘‘SEC. 714. TESTING BY ACCREDITED LABORATORIES. 
‘‘(a) IN GENERAL.— 
‘‘(1) REQUIREMENT.—Whenever analytical test-
ing of an article of food is conducted as part of testi-
mony for the purposes of section 801(a), or for such
other purposes as the Secretary deems appropriate 
through regulation or guidance, such testing shall be 
conducted by a laboratory that— 
‘‘(A) is accredited, for the analytical meth-
od used, by a laboratory accreditation body that 
has been recognized by the Secretary; and 
‘‘(B) samples such article with adequate 
controls for ensuring the integrity of the sam-
ples analyzed. 
‘‘(2) INDEPENDENCE OF LABORATORY.— 
‘‘(A) CERTAIN TESTS.—Tests required for 
purposes of section 801(a) or in response to a 
finding of noncompliance by the Secretary shall 
be conducted by a laboratory independent of the 
person on whose behalf such testing is con-
ducted and analyzed. 
‘‘(B) CERTAIN PRODUCTS.—The Secretary 
may require that testing for certain products 
under paragraph (1) be conducted by a labora-
tory independent of the person on whose behalf 
such testing is conducted. 
‘‘(b) RECOGNITION OF LABORATORY ACCREDITATION 
BODIES.—The Secretary shall establish and implement a 
program for the recognition, based on standards the Sec-
retary deems appropriate, of laboratory accreditation bod-
ies that accredit laboratories to perform analytical testing 
for the purposes of this section. The Secretary shall issue 
regulations or guidance to implement this program. 
‘‘(c) ONSITE AUDITS.—In evaluating whether an ac-
creditation body meets, or continues to meet, the stand-
ards for recognition under subsection (b), the Secretary 
may— 
‘‘(1) observe onsite audits of laboratories by 
such accreditation bodies; or 
‘‘(2) for any laboratory that is accredited by 
such accreditation body under this section, upon re-
quest of an officer or employee designated by the 
Secretary and upon presentation of appropriate cre-
dentials, at reasonable times and within reasonable 
limits and in a reasonable manner, conduct an onsite 
audit of the laboratory, which shall include access to, 
and copying and verification of, any related records. 
‘‘(d) PUBLICATION OF LIST OF RECOGNIZED AC-
CREDITATION BODIES.—The Secretary shall publish and 
maintain on the public Web site of the Food and Drug 
Administration a list of accreditation bodies recognized by 
the Secretary under subsection (b). 
‘‘(e) NOTIFICATION OF ACCREDITATION OF LABORA-
TORY.—An accreditation body that has been recognized 
pursuant to this section shall promptly notify the Sec-
retary whenever it accredits a laboratory for the purposes 
of this section and whenever it withdraws or suspends 
such accreditation. 
‘‘(f) ADVANCE NOTICE.—Whenever analytical testing 
is conducted pursuant to subsection (a), the person on 
whose behalf the testing is conducted shall notify the Sec-
retary before any sample of the article is collected. Such 
notice shall contain information the Secretary determines 
is appropriate to identify the article, the location of the 
article, and each laboratory that will analyze the sample 
on the person’s behalf. 
‘‘(g) CONTENTS
OF
LABORATORY
PACKAGES.— 
Whenever analytical testing is conducted pursuant to sub-
section (a), the laboratory conducting such testing shall 
submit, directly to the Secretary— 
‘‘(1) the results of all analyses conducted by the 
laboratory on each sample of such article; and 
‘‘(2) all information the Secretary deems appro-
priate to— 
‘‘(A) determine whether the laboratory is 
accredited by a recognized laboratory accredita-
tion body; 
‘‘(B) identify the article tested; 
‘‘(C) evaluate the analytical results; and
‘‘(D) determine whether the requirements 
of this section have been met. 
‘‘(h) EXIGENT
CIRCUMSTANCES.—The Secretary 
may waive the requirement of subsection (a)(1)(A) (relat-
ing to analytical methods) on a laboratory or method basis 
due to exigent or other circumstances. 
‘‘(i) FEDERAL LABORATORY TESTING.—If Customs 
and Border Protection laboratory testing concludes that 
an article of food is adulterated or misbranded, the Sec-
retary shall consider and utilize as appropriate the testing 
results issued by the Customs and Border Protection lab-
oratories in making a decision about the admissibility of 
the product. 
‘‘(j) NO LIMIT ON AUTHORITY.—Nothing in this sec-
tion shall be construed to limit— 
‘‘(1) the ability of the Secretary to review and 
act upon information from the analytical testing of 
food (including under this section), including deter-
mining the sufficiency of such information and test-
ing; or 
‘‘(2) the authority of the Secretary to conduct, 
require, or consider the results of analytical testing 
pursuant to any other provision of law.’’.
SEC. 111. NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED FOOD. 
(a) PROHIBITED ACTS.—Section 301 (21 U.S.C. 
331), as amended by section 110, is amended by adding 
at the end the following: 
‘‘(vv)(1) The failure to notify the Secretary in viola-
tion of section 420(a). 
‘‘(2) The failure to comply with any order issued 
under section 420.’’. 
(b) NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED FOOD.—Chapter IV 
(21 U.S.C. 341 et seq.), as amended by sections 102, 103, 
and 104, is amended by adding at the end the following: 
‘‘SEC. 420. NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED FOOD. 
‘‘(a) NOTIFICATION, NONDISTRIBUTION, AND RE-
CALL OF ADULTERATED OR MISBRANDED FOOD.— 
‘‘(1) IN GENERAL.—A responsible party as that 
term is defined in section 417(a)(1) or a person re-
quired to register under section 801(s) that has rea-
son to believe that an article of food when intro-
duced into or while in interstate commerce, or while 
held for sale (regardless of whether the first sale) 
after shipment in interstate commerce, is adulter-
ated or misbranded in a manner that presents a rea-
sonable probability that the use or consumption of,
or exposure to, the article (or an ingredient or com-
ponent used in any such article) will cause a threat 
of serious adverse health consequences or death to 
humans or animals shall, as soon as practicable, no-
tify 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 or guidance. 
‘‘(b) VOLUNTARY RECALL.—The Secretary may re-
quest that any person who distributes an article of food 
that the Secretary has reason to believe is adulterated, 
misbranded, or otherwise in violation of this Act volun-
tarily— 
‘‘(1) recall such article; and 
‘‘(2) provide for notice, including to individuals 
as appropriate, to persons who may be affected by 
the recall. 
‘‘(c) ORDER TO CEASE DISTRIBUTION.—If the Sec-
retary has reason to believe that the use or consumption 
of, or exposure to, an article of food may cause serious 
adverse health consequences or death to humans or ani-
mals, the Secretary shall have the authority to issue an
order requiring any person who distributes such article to 
immediately cease distribution of such article. 
‘‘(d) ACTION FOLLOWING ORDER.—Any person who 
is subject to an order under subsection (c) shall imme-
diately cease distribution of such article and provide notifi-
cation as required by such order, and may appeal within 
24 hours of issuance such order to the Secretary. Such 
appeal may include a request for an informal hearing and 
a description of any efforts to recall such article under-
taken voluntarily by the person, including after a request 
under subsection (b). Except as provided in subsection (f), 
an informal hearing shall be held as soon as practicable, 
but not later than 5 calendar days, or less as determined 
by the Secretary, after such an appeal is filed, unless the 
parties jointly agree to an extension. After affording an 
opportunity for an informal hearing, the Secretary shall 
determine whether the order should be amended to require 
a recall of such article. If, after providing an opportunity 
for such a hearing, the Secretary determines that inad-
equate grounds exist to support the actions required by 
the order, the Secretary shall vacate the order. 
‘‘(e) ORDER TO RECALL.— 
‘‘(1) AMENDMENT.—Except as provided under 
subsection (f), if after providing an opportunity for 
an informal hearing under subsection (d), the Sec-
retary determines that the order should be amended 
to include a recall of the article with respect to 
which the order was issued, the Secretary shall 
amend the order to require a recall. 
‘‘(2) CONTENTS.—An amended order under 
paragraph (1) shall— 
‘‘(A) specify a timetable in which the recall 
will occur; 
‘‘(B) require periodic reports to the Sec-
retary describing the progress of the recall; and 
‘‘(C) provide for notice, including to indi-
viduals as appropriate, to persons who may be 
affected by the recall. 
In providing for such notice, the Secretary may 
allow for the assistance of health professionals, State 
or local officials, or other individuals designated by 
the Secretary. 
‘‘(3) NONDELEGATION.—An amended order 
under this subsection shall be ordered by the Sec-
retary or an official designated by the Secretary. An 
official may not be so designated unless the official 
is the director of the district under this Act in which 
the article involved is located, or is an official senior 
to such director. 
‘‘(f) EMERGENCY RECALL ORDER.—
‘‘(1) IN GENERAL.—If the Secretary has cred-
ible evidence or information that an article of food 
subject to an order under subsection (c) presents an 
imminent threat of serious adverse health con-
sequences or death to humans or animals, the Sec-
retary may issue an order requiring any person who 
distributes such article— 
‘‘(A) to immediately recall such article; and 
‘‘(B) to provide for notice, including to in-
dividuals as appropriate, to persons who may be 
affected by the recall. 
‘‘(2) ACTION FOLLOWING ORDER.—Any person 
who is subject to an emergency recall order under 
this subsection shall immediately recall such article 
and provide notification as required by such order, 
and may appeal within 24 hours after issuance such 
order to the Secretary. An informal hearing shall be 
held within as soon as practicable but not later than 
5 calendar days, or less as determined by the Sec-
retary, after such an appeal is filed, unless the par-
ties jointly agree to an extension. After affording an 
opportunity for an informal hearing, the Secretary 
shall determine whether the order should be amend-
ed pursuant to subsection (e)(1). If, after providing 
an opportunity for such a hearing, the Secretary de-
termines that inadequate grounds exist to support 
the actions required by the order, the Secretary shall 
vacate the order. 
‘‘(3) NONDELEGATION.—An order under this 
subsection shall be issued by the Commissioner of 
Food and Drugs, the Principal Deputy Commis-
sioner, or the Associate Commissioner for Regu-
latory Affairs of the Food and Drug Administration. 
‘‘(g) NOTICE TO CONSUMERS AND HEALTH OFFI-
CIALS.—The Secretary shall, as the Secretary determines 
to be necessary, provide notice of a recall order under this 
section to consumers to whom the article was, or may have 
been, distributed and to appropriate State and local health 
officials. 
‘‘(h) SAVINGS CLAUSE.—Nothing contained in this 
section shall be construed as limiting— 
‘‘(1) the authority of the Secretary to issue an 
order to cease distribution of, or to recall, an article 
under any other provision of this Act or the Public 
Health Service Act; or 
‘‘(2) the ability of the Secretary to request any 
person to perform a voluntary activity related to any 
article subject to this Act or the Public Health Serv-
ice Act.’’.
(c) ARTICLES SUBJECT
TO REFUSAL.—The third 
sentence of subsection (a) of section 801 (21 U.S.C. 381), 
as amended by section 107(b), is amended by inserting 
‘‘or (5) such article is subject to an order under section 
420 to cease distribution of or recall the article,’’ before 
‘‘then such article shall be refused admission’’. 
(d) EFFECTIVE DATE.—Sections 301(vv)(1) and 420 
of the Federal Food, Drug, and Cosmetic Act, as added 
by subsections (a) and (b), shall apply with respect to arti-
cles of food as of such date, not later than 1 year after 
the date of the enactment of this Act, as the Secretary 
of Health and Human Services shall specify. 
SEC. 112. REPORTABLE FOOD REGISTRY; EXCHANGE OF IN-
FORMATION. 
(a) REPORTABLE FOOD REGISTRY.—Section 417 (21 
U.S.C. 350f) is amended— 
(1) in subsection (a)(1), by striking ‘‘means a 
person’’ and all that follows through the end of 
paragraph (1) and inserting the following: ‘‘means— 
‘‘(A) a person who submits the registration 
under section 415(a) for a food facility that is 
required to be registered under section 415(a), 
at which such food is manufactured, processed, 
packed, or held;
100 
‘‘(B) a person who owns, operates, is an 
agent of, or is otherwise responsible for such 
food on a farm (as such term is defined in sec-
tion 1.227(b)(3) of title 21, Code of Federal 
Regulations, or successor regulations) at which 
such food is produced for sale or distribution in 
interstate commerce; 
‘‘(C) a person who owns, operates, or is an 
agent of a restaurant or other retail food estab-
lishment (as such terms are defined in section 
1.227(b)(11) and (12), respectively, of title 21, 
Code of Federal Regulations, or successor regu-
lations) at which such food is offered for sale; 
or 
‘‘(D) a person that is required to register 
pursuant to section 801(s) with respect to im-
portation of such food.’’; 
(2) in subsection (b), by adding at the end the 
following: 
‘‘(3) REPORTING
BY
FARMS, RESTAURANTS, 
AND RETAIL FOOD ESTABLISHMENTS.—In addition 
to the electronic portal described in paragraph (1), 
the Secretary shall make available alternative means 
of reporting under this section with respect to farms,
101 
restaurants, and other retail food establishments 
with limited ability for such reporting.’’; 
(3) in subsection (d)(1)— 
(A) in the matter preceding subparagraph 
(A), by inserting ‘‘following a timely review of 
any reasonably available data and information,’’ 
after ‘‘reportable food,’’; 
(B) in subparagraph (A), by striking 
‘‘and’’ at the end; 
(C) by redesignating subparagraph (B) as 
subparagraph (C); and 
(D) by inserting after subparagraph (A) 
the following: 
‘‘(B) submit, with such report, through the 
electronic portal, documentation of results from 
any sampling and testing of such article, includ-
ing— 
‘‘(i) analytical results from testing of 
such article conducted by or on behalf of 
the responsible party under section 418, 
418A, 419, 419A, or 714; 
‘‘(ii) analytical results from testing 
conducted by or on behalf of such respon-
sible party of a component of such article;
102 
‘‘(iii) analytical results of environ-
mental testing of any facility at which such 
article, or a component of such article, is 
manufactured, processed, packed, or held; 
and 
‘‘(iv) any other information the Sec-
retary determines is necessary to evaluate 
the adulteration of such article, any com-
ponent of such article, any other article of 
food manufactured, processed, packed or 
held in the same manner as, or at the 
same facility as, such article, or any other 
article containing a component from the 
same source as a component of such arti-
cle; and’’; and 
(4) in subsection (e)— 
(A) in paragraph (1), by inserting ‘‘if the 
responsible party is required to register’’ after 
‘‘415(a)(3)’’; and 
(B) by adding at the end the following: 
‘‘(12) Such additional information as the Sec-
retary deems appropriate.’’. 
(b) EXCHANGE OF INFORMATION.—Section 708 (21 
U.S.C. 379) is amended—
103 
(1) by striking ‘‘The Secretary’’ and inserting 
‘‘(a) The Secretary’’; and 
(2) by adding at the end the following: 
‘‘(b)(1)(A) The Secretary may provide to any Federal 
agency acting within the scope of its jurisdiction any infor-
mation relating to food that is exempt from disclosure pur-
suant to subsection (a) of section 552 of title 5, United 
States Code, by reason of subsection (b)(4) of such sec-
tion, or that is referred to in section 301(j) or 415(a)(4). 
‘‘(B) Any such information provided to another Fed-
eral agency shall not be disclosed by such agency except 
in any action or proceeding under the laws of the United 
States to which the receiving agency or the United States 
is a party. 
‘‘(2)(A) In carrying out this Act, the Secretary may 
provide to a State or local government agency any infor-
mation relating to food that is exempt from disclosure pur-
suant to section 552(a) of title 5, United States Code, by 
reason of subsection (b)(4) of such section, or that is re-
ferred to in section 301(j) or 415(a)(4). 
‘‘(B) Any such information provided to a State or 
local government agency shall not be disclosed by such 
agency. 
‘‘(3) In carrying out this Act, the Secretary may pro-
vide to any person any information relating to food that
104 
is exempt from disclosure pursuant to section 552(a) of 
title 5, United States Code, by reason of subsection (b)(4) 
of such section, if the Secretary determines that providing 
the information to the person is appropriate under the cir-
cumstances and the recipient provides adequate assur-
ances to the Secretary that the recipient will preserve the 
confidentiality of the information. 
‘‘(4) In carrying out this Act, the Secretary may pro-
vide any information relating to food that is exempt from 
disclosure pursuant to section 552(a) of title 5, United 
States Code, by reason of subsection (b)(4) of such sec-
tion, or that is referred to in section 301(j)— 
‘‘(A) to any foreign government agency; or 
‘‘(B) any international organization established 
by law, treaty, or other governmental action and 
having responsibility— 
‘‘(i) to facilitate global or regional harmo-
nization of standards and requirements in an 
area of responsibility of the Food and Drug Ad-
ministration; or 
‘‘(ii) to promote and coordinate public 
health efforts, 
if the agency or organization provides adequate as-
surances to the Secretary that the agency or organi-
105 
zation will preserve the confidentiality of the infor-
mation. 
‘‘(c) Except where specifically prohibited by statute, 
the Secretary may disclose to the public any information 
relating to food that is exempt from disclosure pursuant 
to section 552(a) of title 5, United States Code, by reason 
of subsection (b)(4) of such section, if the Secretary deter-
mines that such disclosure is necessary to protect the pub-
lic health. 
‘‘(d) Except as provided in subsection (e), the Sec-
retary shall not be required to disclose under section 552 
of title 5, United States Code, or any other provision of 
law any information relating to food obtained from a Fed-
eral, State, or local government agency, or from a foreign 
government agency, or from an international organization 
described in subsection (b)(4), if the agency or organiza-
tion has requested that the information be kept confiden-
tial, or has precluded such disclosure under other use limi-
tations, as a condition of providing the information. 
‘‘(e) Nothing in subsection (d) authorizes the Sec-
retary to withhold information from the Congress or pre-
vents the Secretary from complying with an order of a 
court of the United States.
106 
‘‘(f) This section shall not affect the authority of the 
Secretary to provide or disclose information under any 
other provision of law.’’. 
(c) CONFORMING AMENDMENT.—Section 301(j) (21 
U.S.C. 331(j)) is amended by striking ‘‘or to the courts 
when relevant in any judicial proceeding under this Act,’’ 
and inserting ‘‘to the courts when relevant in any judicial 
proceeding under this Act, or as specified in section 708,’’. 
SEC. 113. SAFE AND SECURE FOOD IMPORTATION PRO-
GRAM. 
Chapter VIII (21 U.S.C. 381 et seq.) is amended by 
adding at the end the following: 
‘‘SEC. 805. SAFE AND SECURE FOOD IMPORTATION PRO-
GRAM. 
‘‘(a) IN GENERAL.—The Secretary may establish by 
regulation or guidance in coordination with the Commis-
sioner responsible for Customs and Border Protection a 
program that facilitates the movement of food through the 
importation process under this Act if the importer of such 
food— 
‘‘(1) verifies that each facility involved in the 
production, manufacture, processing, packaging, and 
holding of the food is in compliance with the food 
safety and security guidelines developed under sub-
section (b) with respect to such food;
107 
‘‘(2) ensures that appropriate safety and secu-
rity controls are in place throughout the supply 
chain for such food; and 
‘‘(3) provides supporting information to the 
Secretary. 
‘‘(b) GUIDELINES.— 
‘‘(1) DEVELOPMENT.—For purposes of the pro-
gram established under subsection (a), the Secretary 
shall develop in consultation with the Commissioner 
responsible for Customs and Border Protection safe-
ty and security guidelines applicable to the importa-
tion of food taking into account, to the extent appro-
priate, other relevant Federal programs, such as the 
Customs-Trade Partnership Against Terrorism (C- 
TPAT) programs under section 211 of the Security 
and Accountability for Every Port Act of 2006. 
‘‘(2) FACTORS.—Such guidelines shall take into 
account the following factors: 
‘‘(A) The personnel of the person import-
ing the food. 
‘‘(B) The physical and procedural safety 
and security of such person’s food supply chain. 
‘‘(C) The sufficiency of preventive controls 
for food and ingredients purchased by such per-
son.
108 
‘‘(D) Vendor and supplier information. 
‘‘(E) Other programs for certification or 
verification by a qualified certifying entity used 
by the importer. 
‘‘(F) Such other factors as the Secretary 
determines necessary.’’. 
SEC. 114. INFANT FORMULA. 
(a) MISBRANDING.—Section 403 (21 U.S.C. 343), as 
amended by sections 101(a) and 109(a), is amended by 
adding at the end the following: 
‘‘(bb) If it is a new infant formula and— 
‘‘(1) it is not the subject of a registration made 
pursuant to section 412(c)(1)(A); 
‘‘(2) it is not the subject of a submission made 
pursuant to section 412(c)(1)(B), or 
‘‘(3) at least 90 days have not passed since the 
making of such registration or of such submission to 
the Secretary.’’. 
(b) REQUIREMENTS.—Section 412 (21 U.S.C. 350a) 
is amended— 
(1) in subsection (c)(1)(B), by striking ‘‘(c)(1)’’ 
at the end and inserting ‘‘(d)(1), subject to sub-
section (d)(2)(B)’’; 
(2) in subsection (d)(1)—
109 
(A) by striking ‘‘and’’ at the end of sub-
paragraph (C); 
(B) by striking the period at the end of 
subparagraph (D) and inserting ‘‘, and’’; and 
(C) by adding at the end the following: 
‘‘(E) information on any new ingredient in 
accordance with paragraph (2)(A).’’; 
(3) in subsection (d), by redesignating para-
graphs (2) and (3) as paragraphs (3) and (4), re-
spectively; and 
(4) by inserting after paragraph (1) of sub-
section (d) the following: 
‘‘(2)(A) The description of any new infant formula 
required under paragraph (1) shall include, for any new 
ingredient for use in the formula— 
‘‘(i) a citation to a prior approval by the Sec-
retary of the new ingredient for use in infant for-
mula under section 409; 
‘‘(ii) a citation to or information showing a 
prior consideration of the new ingredient for use in 
infant formula under any program established by the 
Secretary for the review of ingredients used in food; 
or 
‘‘(iii) for a new ingredient that is not a food ad-
ditive or a color additive, information equivalent to
110 
that provided under any program established by the 
Secretary for the review of ingredients used in food. 
‘‘(B) If the information submitted under subpara-
graph (A) is the information described in clause (iii) of 
such subparagraph, the 90 day period provided by sub-
section (c)(1)(B) shall not commence until the Secretary 
has completed review of the information submitted under 
such clause and has provided the submitter notice of the 
results of such review.’’. 
Subtitle B—Intervention 
SEC. 121. SURVEILLANCE. 
(a) DEFINITION
OF FOOD-BORNE ILLNESS OUT-
BREAK.—In this section, the term ‘‘food-borne illness out-
break’’ means the occurrence of 2 or more cases of a simi-
lar illness resulting from the ingestion of a food. 
(b) FOOD-BORNE
ILLNESS
SURVEILLANCE
SYS-
TEMS.—The Secretary of Health and Human Services (in 
this subtitle referred to as the ‘‘Secretary’’), acting 
through the Director of the Centers for Disease Control 
and Prevention, shall enhance food-borne illness surveil-
lance systems to improve the collection, analysis, report-
ing, and usefulness of data on food-borne illnesses by— 
(1) coordinating Federal, State, and local food- 
borne illness surveillance systems, including com-
plaint systems, and increasing participation in na-
111 
tional networks of public health and food regulatory 
agencies and laboratories; 
(2) facilitating sharing of findings on a more 
timely basis among governmental agencies, including 
the Food and Drug Administration, the Department 
of Agriculture, and State and local agencies, and 
with the public; 
(3) developing improved epidemiological tools 
for obtaining quality exposure data, and micro-
biological methods for classifying cases; 
(4) augmenting such systems to improve attri-
bution of a food-borne illness outbreak to a specific 
food; 
(5) expanding capacity of such systems, includ-
ing fingerprinting and other detection strategies for 
food-borne infectious agents, in order to identify new 
or rarely documented causes of food-borne illness; 
(6) allowing timely public access to aggregated, 
de-identified surveillance data; 
(7) at least annually, publishing current reports 
on findings from such systems; 
(8) establishing a flexible mechanism for rapidly 
initiating scientific research by academic institu-
tions;
112 
(9) integrating food-borne illness surveillance 
systems and data with other biosurveillance and 
public health situational awareness capabilities at 
the Federal, State, and local levels; and 
(10) other activities as determined appropriate 
by the Secretary. 
(c) IMPROVING FOOD SAFETY AND DEFENSE CAPAC-
ITY AT THE STATE AND LOCAL LEVEL.— 
(1) IN GENERAL.—The Secretary shall develop 
and implement strategies to leverage and enhance 
the food safety and defense capacities of State and 
local agencies in order to achieve the following goals: 
(A) Improve food-borne illness outbreak re-
sponse and containment. 
(B) Accelerate food-borne illness surveil-
lance and outbreak investigation, including 
rapid shipment of clinical isolates from clinical 
laboratories to appropriate State laboratories, 
and conducting more standardized illness out-
break interviews. 
(C) Strengthen the capacity of State and 
local agencies to carry out inspections and en-
force safety standards. 
(D) Improve the effectiveness of Federal, 
State, and local partnerships to coordinate food
113 
safety and defense resources and reduce the in-
cidence of food-borne illness. 
(E) Share information on a timely basis 
among public health and food regulatory agen-
cies, with the food industry, with health care 
providers, and with the public. 
(2) REVIEW.—In developing the strategies re-
quired by paragraph (1), the Secretary shall, not 
later than 1 year after the date of enactment of this 
Act, complete a review of State and local capacities, 
and needs for enhancement, which may include a 
survey with respect to— 
(A) staffing levels and expertise available 
to perform food safety and defense functions; 
(B) laboratory capacity to support surveil-
lance, outbreak response, inspection, and en-
forcement activities; 
(C) information systems to support data 
management and sharing of food safety and de-
fense information among State and local agen-
cies and with counterparts at the Federal level; 
and 
(D) other State and local activities and 
needs as determined appropriate by the Sec-
retary.
114 
SEC. 122. PUBLIC EDUCATION AND ADVISORY SYSTEM. 
(a) PUBLIC EDUCATION.—The Secretary, in coopera-
tion with private and public organizations, including the 
appropriate State entities, shall design and implement a 
national public education program on food safety. The 
program shall provide— 
(1) information to the public so that individuals 
can understand the potential impact and risk of 
food-borne illness, take action to reduce their risk of 
food-borne illness and injury, and make healthy die-
tary choices; 
(2) information to health professionals so that 
they may improve diagnosis and treatment of food- 
related illness and advise individuals whose health 
conditions place them in particular risk; and 
(3) such other information or advice to con-
sumers and other persons as the Secretary deter-
mines will promote the purposes of this Act. 
(b) HEALTH ADVISORIES.—The Secretary shall work 
with the States and other appropriate entities to— 
(1) develop and distribute regional and national 
advisories concerning food safety; 
(2) develop standardized formats for written 
and broadcast advisories; and
115 
(3) incorporate State and local advisories into 
the national public education program required 
under subsection (a). 
SEC. 123. RESEARCH. 
The Secretary shall conduct research to assist in the 
implementation of this Act, including studies to— 
(1) improve sanitation and food safety practices 
in the production, harvesting, and processing of food 
products; 
(2) develop improved techniques for the moni-
toring 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, including critical points of 
risk for fresh produce and other raw agricultural 
commodities; 
(5) develop consumption data with respect to 
food products; 
(6) draw upon research and educational pro-
grams that exist at the State and local level; 
(7) utilize the DNA matching system and other 
processes to identify and control pathogens;
116 
(8) address common and emerging zoonotic dis-
eases; 
(9) develop methods to reduce or destroy patho-
gens before, during, and after processing; 
(10) analyze the incidence of antibiotic resist-
ance as it pertains to the food supply and evaluate 
methods to reduce the transfer of antibiotic resist-
ance to humans; and 
(11) conduct other research that supports the 
purposes of this Act. 
Subtitle C—Response 
SEC. 131. PROCEDURES FOR SEIZURE. 
Section 304(b) (21 U.S.C. 334(b)) is amended by in-
serting ‘‘and except that, with respect to proceedings relat-
ing to food, Rule G of the Supplemental Rules of Admi-
ralty or Maritime Claims and Asset Forfeiture Actions 
shall not apply in any such case, exigent circumstances 
shall be deemed to exist for all seizures brought under this 
section, and the summons and arrest warrant shall be 
issued by the clerk of the court without court review in 
any such case’’ after ‘‘in any such case shall be tried by 
jury’’. 
SEC. 132. ADMINISTRATIVE DETENTION. 
(a) AMENDMENTS.—Section 304(h) (21 U.S.C. 
334(h)) is amended—
117 
(1) in paragraph (1)(A), by striking ‘‘credible 
evidence or information indicating’’ and inserting 
‘‘reason to believe’’; 
(2) in paragraph (1)(A), by striking ‘‘presents 
a threat of serious adverse health consequences or 
death to humans or animals’’ and inserting ‘‘is adul-
terated, misbranded, or otherwise in violation of this 
Act’’; 
(3) in paragraph (2), by striking ‘‘30’’ and in-
serting ‘‘60’’; 
(4) in paragraph (3), by striking the third sen-
tence; and 
(5) in paragraph (4)(A) by striking the terms 
‘‘five’’ and ‘‘five-day’’ and inserting ‘‘fifteen’’ and 
‘‘fifteen-day’’, respectively. 
(b) REGULATIONS.—The Secretary shall issue regula-
tions or guidance to implement the amendments made by 
this section. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall take effect 180 days after the date of 
the enactment of this Act.
118 
SEC. 133. AUTHORITY TO PROHIBIT OR RESTRICT THE 
MOVEMENT OF FOOD. 
(a) PROHIBITED ACT.—Section 301 (21 U.S.C. 331), 
as amended by sections 110 and 111, is amended by add-
ing at the end by adding the following: 
‘‘(ww) The violation of a prohibition or restriction 
under section 304(i).’’. 
(b) IN GENERAL.—Section 304 (21 U.S.C. 334) is 
amended by adding at the end the following: 
‘‘(i) AUTHORITY TO PROHIBIT OR RESTRICT THE 
MOVEMENT OF FOOD WITHIN A STATE OR PORTION OF 
A STATE.— 
‘‘(1) AUTHORITY
TO
PROHIBIT
OR
RESTRICT 
THE MOVEMENT OF FOOD.— 
‘‘(A) IN GENERAL.— 
‘‘(i) After consultation with the Gov-
ernor or other appropriate official of an af-
fected State, if the Secretary determines 
that there is credible evidence that an arti-
cle of food presents an imminent threat of 
serious adverse health consequences or 
death to humans or animals, the Secretary 
may prohibit or restrict the movement of 
an article of food within a State or portion 
of a State for which the Secretary has 
credible evidence that such food is located
119 
within, or originated from, such State or 
portion thereof. 
‘‘(ii) In carrying out clause (i), the 
Secretary may prohibit or restrict the 
movement within a State or portion of a 
State of any article of food or means of 
conveyance of such article of food, if the 
Secretary determines that the prohibition 
or restriction is a necessary protection 
from an imminent threat of serious adverse 
health consequences or death to humans or 
animals. 
‘‘(2) NOTIFICATION PROCEDURES.—Subject to 
paragraph (3), before any action is taken in a State 
under this subsection, the Secretary shall— 
‘‘(A) notify the Governor or other appro-
priate official of the State affected by the pro-
posed action; 
‘‘(B) issue a public announcement of the 
proposed action; and 
‘‘(C) publish in the Federal Register— 
‘‘(i) the findings of the Secretary that 
support the proposed action; 
‘‘(ii) a statement of the reasons for 
the proposed action; and
120 
‘‘(iii) a description of the proposed ac-
tion, including— 
‘‘(I) the area affected; and 
‘‘(II) an estimate of the antici-
pated duration of the action. 
‘‘(3) NOTICE AFTER ACTION.—If it is not prac-
ticable to publish in the Federal Register the infor-
mation required under paragraph (2)(C) before tak-
ing action under paragraph (1), the Secretary shall 
publish the information as soon as practicable, but 
not later than 10 business days, after commence-
ment of the action. 
‘‘(4) APPLICATION
OF
LEAST
DRASTIC
AC-
TION.—No action shall be taken under paragraph 
(1) unless, in the opinion of the Secretary, there is 
no less drastic action that is feasible and that would 
be adequate to prevent the imminent threat of seri-
ous adverse health consequences or death to humans 
or animals. 
‘‘(5) NONDELEGATION.—An action under para-
graph (1) may only be ordered by the Secretary or 
an official designated by the Secretary. An official 
may not be so designated unless the official is the 
Commissioner of Food and Drugs or the Principal 
Deputy Commissioner.
121 
‘‘(6) DURATION.—Fourteen days after the initi-
ation of an action under paragraph (1), and each 14 
days thereafter, if the Secretary determines that it 
is necessary to continue the action, the Secretary 
shall— 
‘‘(A) notify the Governor or other appro-
priate official of the State affected of the con-
tinuation of the action; 
‘‘(B) issue a public announcement of the 
continuation of the action; and 
‘‘(C) publish in the Federal Register the 
findings of the Secretary that support the con-
tinuation of the action, including an estimate of 
the anticipated duration of the action. 
‘‘(7) RULEMAKING.—The Secretary shall, con-
sistent with national security interests and as appro-
priate for known hazards, establish by regulation 
standards for conducting actions under paragraph 
(1), including, as appropriate, sanitation standards 
and procedures to restore any affected equipment or 
means of conveyance to its status prior to an action 
under paragraph (1).’’. 
SEC. 134. CRIMINAL PENALTIES. 
Section 303(a) (21 U.S.C. 333) is amended—
122 
(1) in paragraph (1), by striking ‘‘Any’’ and in-
serting ‘‘Except as provided in paragraph (2) or (3), 
any’’; and 
(2) by adding at the end the following: 
‘‘(3) Notwithstanding paragraph (1), any person who 
knowingly violates paragraph (a), (b), (c), (k), or (v) of 
section 301 with respect to any food that is misbranded 
or adulterated shall be imprisoned for not more than 10 
years or fined in accordance with title 18, United States 
Code, or both.’’. 
SEC. 135. CIVIL PENALTIES FOR VIOLATIONS RELATING TO 
FOOD. 
(a) IN GENERAL.—Paragraph (2) of section 303(f) 
(21 U.S.C. 331 et seq.) is amended to read as follows: 
‘‘(2)(A) Any person who violates a provision of 
section 301 relating to food shall be subject to a civil 
penalty for each such violation of not more than— 
‘‘(i) $20,000 in the case of an individual, 
not to exceed $50,000 in a single proceeding; 
and 
‘‘(ii) $250,000 in the case of any other 
person, not to exceed $1,000,000 in a single 
proceeding. 
‘‘(B) Any person who knowingly violates a pro-
vision of section 301 relating to food shall be subject
129 
to this subparagraph shall be credited to the appropriation 
account for salaries and expenses of the Food and Drug 
Administration and shall be available in accordance with 
appropriations Acts until expended, without fiscal year 
limitation. Such fees shall be collected in each fiscal year 
in an amount equal to the amount specified in appropria-
tions Acts for such fiscal year and shall only be collected 
and available for the costs of the Food and Drug Adminis-
tration to cover the cost of issuing such certifications. 
Such sums as necessary may be transferred from such ap-
propriation account for salaries and expenses of the Food 
and Drug Administration without fiscal year limitation to 
such appropriation account for salaries and expenses with 
fiscal year limitation.’’. 
SEC. 204. REGISTRATION FOR COMMERCIAL IMPORTERS 
OF FOOD; FEE. 
(a) REGISTRATION.— 
(1) PROHIBITIONS.—Section 301 (21 U.S.C. 
331), as amended by sections 110, 111, 133, and 
136, is amended by adding at the end the following: 
‘‘(zz) The failure to register in accordance with sec-
tion 801(s).’’. 
(2) MISBRANDING.—Section 403 (21 U.S.C. 
343) as amended by sections 101(a), 109(a), 114(a),