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•AMDT. NO. 4805 
(c) PRODUCT TRACING SYSTEM.—The Secretary, in 
consultation with the Secretary of Agriculture, shall, as 
appropriate, establish within the Food and Drug Adminis-
tration a product tracing system to receive information 
that improves the capacity of the Secretary to effectively 
and rapidly track and trace food that is in the United 
States or offered for import into the United States. Prior 
to the establishment of such product tracing system, the 
Secretary shall examine the results of applicable pilot 
projects and shall ensure that the activities of such system 
are adequately supported by the results of such pilot 
projects. 
(d) ADDITIONAL RECORDKEEPING REQUIREMENTS 
FOR HIGH-RISK FOODS.— 
(1) IN GENERAL.—In order to rapidly and ef-
fectively identify recipients of a food to prevent or 
mitigate a foodborne illness outbreak and to address 
credible threats of serious adverse health con-
sequences or death to humans or animals as a result 
of such food being adulterated under section 402 of 
the Federal Food, Drug, and Cosmetic Act or mis-
branded under section 403(w) of such Act, not later 
than 2 years after the date of enactment of this Act, 
the Secretary shall publish a notice of proposed rule-
making to establish recordkeeping requirements, in 
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•AMDT. NO. 4805 
addition to the requirements under section 414 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 350c) and subpart J of part 1 of title 21, 
Code of Federal Regulations (or any successor regu-
lations), for facilities that manufacture, process, 
pack, or hold foods that the Secretary designates 
under paragraph (2) as high-risk foods. The Sec-
retary shall set an appropriate effective date of such 
additional requirements for foods designated as high 
risk that takes into account the length of time nec-
essary to comply with such requirements. Such re-
quirements shall— 
(A) relate only to information that is rea-
sonably available and appropriate; 
(B) be science-based; 
(C) not prescribe specific technologies for 
the maintenance of records; 
(D) ensure that the public health benefits 
of imposing additional recordkeeping require-
ments outweigh the cost of compliance with 
such requirements; 
(E) be scale-appropriate and practicable 
for facilities of varying sizes and capabilities 
with respect to costs and recordkeeping bur-
dens, and not require the creation and mainte-
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•AMDT. NO. 4805 
nance of duplicate records where the informa-
tion is contained in other company records kept 
in the normal course of business; 
(F) minimize the number of different rec-
ordkeeping requirements for facilities that han-
dle more than 1 type of food; 
(G) to the extent practicable, not require a 
facility to change business systems to comply 
with such requirements; 
(H) allow any person subject to this sub-
section to maintain records required under this 
subsection at a central or reasonably accessible 
location provided that such records can be made 
available to the Secretary not later than 24 
hours after the Secretary requests such records; 
(I) include a process by which the Sec-
retary may issue a waiver of the requirements 
under this subsection if the Secretary deter-
mines that such requirements would result in 
an economic hardship for an individual facility 
or a type of facility; 
(J) be commensurate with the known safe-
ty risks of the designated food; 
(K) take into account international trade 
obligations; 
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•AMDT. NO. 4805 
(L) not require— 
(i) a full pedigree, or a record of the 
complete previous distribution history of 
the food from the point of origin of such 
food; 
(ii) records of recipients of a food be-
yond the immediate subsequent recipient of 
such food; or 
(iii) product tracking to the case level 
by persons subject to such requirements; 
and 
(M) include a process by which the Sec-
retary may remove a high-risk food designation 
developed under paragraph (2) for a food or 
type of food. 
(2) DESIGNATION OF HIGH-RISK FOODS.— 
(A) IN GENERAL.—Not later than 1 year 
after the date of enactment of this Act, and 
thereafter as the Secretary determines nec-
essary, the Secretary shall designate high-risk 
foods for which the additional recordkeeping re-
quirements described in paragraph (1) are ap-
propriate and necessary to protect the public 
health. Each such designation shall be based 
on— 
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•AMDT. NO. 4805 
(i) the known safety risks of a par-
ticular food, including the history and se-
verity of foodborne illness outbreaks attrib-
uted to such food, taking into consider-
ation foodborne illness data collected by 
the Centers for Disease Control and Pre-
vention; 
(ii) the likelihood that a particular 
food has a high potential risk for micro-
biological or chemical contamination or 
would support the growth of pathogenic 
microorganisms due to the nature of the 
food or the processes used to produce such 
food; 
(iii) the point in the manufacturing 
process of the food where contamination is 
most likely to occur; 
(iv) the likelihood of contamination 
and steps taken during the manufacturing 
process to reduce the possibility of con-
tamination; 
(v) the likelihood that consuming a 
particular food will result in a foodborne 
illness due to contamination of the food; 
and 
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•AMDT. NO. 4805 
(vi) the likely or known severity, in-
cluding health and economic impacts, of a 
foodborne illness attributed to a particular 
food. 
(B) LIST OF HIGH-RISK FOODS.—At the 
time the Secretary promulgates the final rules 
under paragraph (1), the Secretary shall pub-
lish the list of the foods designated under sub-
paragraph (A) as high-risk foods on the Inter-
net website of the Food and Drug Administra-
tion. The Secretary may update the list to des-
ignate new high-risk foods and to remove foods 
that are no longer deemed to be high-risk foods, 
provided that each such update to the list is 
consistent with the requirements of this sub-
section and notice of such update is published 
in the Federal Register. 
(3) PROTECTION
OF
SENSITIVE
INFORMA-
TION.—In promulgating regulations under this sub-
section, the Secretary shall take appropriate meas-
ures to ensure that there are effective procedures to 
prevent the unauthorized disclosure of any trade se-
cret or confidential information that is obtained by 
the Secretary pursuant to this section, including 
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•AMDT. NO. 4805 
periodic risk assessment and planning to prevent un-
authorized release and controls to— 
(A) prevent unauthorized reproduction of 
trade secret or confidential information; 
(B) prevent unauthorized access to trade 
secret or confidential information; and 
(C) maintain records with respect to access 
by any person to trade secret or confidential in-
formation maintained by the agency. 
(4) PUBLIC INPUT.—During the comment pe-
riod in the notice of proposed rulemaking under 
paragraph (1), the Secretary shall conduct not less 
than 3 public meetings in diverse geographical areas 
of the United States to provide persons in different 
regions an opportunity to comment. 
(5) RETENTION OF RECORDS.—Except as oth-
erwise provided in this subsection, the Secretary may 
require that a facility retain records under this sub-
section for not more than 2 years, taking into con-
sideration the risk of spoilage, loss of value, or loss 
of palatability of the applicable food when deter-
mining the appropriate timeframes. 
(6) LIMITATIONS.— 
(A) FARM-TO-SCHOOL PROGRAMS.—In es-
tablishing requirements under this subsection, 
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•AMDT. NO. 4805 
the Secretary shall, in consultation with the 
Secretary of Agriculture, consider the impact of 
requirements on farm-to-school or farm-to-insti-
tution programs of the Department of Agri-
culture and other farm-to-school and farm-to- 
institution programs outside such agency, and 
shall modify the requirements under this sub-
section, as appropriate, with respect to such 
programs so that the requirements do not place 
undue burdens on farm-to-school or farm-to-in-
stitution programs. 
(B) IDENTITY-PRESERVED
LABELS
WITH 
RESPECT TO FARM SALES OF FOOD THAT IS 
PRODUCED AND PACKAGED ON A FARM.—The 
requirements under this subsection shall not 
apply to a food that is produced and packaged 
on a farm if— 
(i) the packaging of the food main-
tains the integrity of the product and pre-
vents subsequent contamination or alter-
ation of the product; and 
(ii) the labeling of the food includes 
the name, complete address (street ad-
dress, town, State, country, and zip or 
other postal code), and business phone 
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•AMDT. NO. 4805 
number of the farm, unless the Secretary 
waives the requirement to include a busi-
ness phone number of the farm, as appro-
priate, in order to accommodate a religious 
belief of the individual in charge of such 
farm. 
(C) FISHING VESSELS.—The requirements 
under this subsection with respect to a food 
that is produced through the use of a fishing 
vessel (as defined in section 3(18) of the Mag-
nuson-Stevens Fishery Conservation and Man-
agement Act (16 U.S.C. 1802(18))) shall be 
limited to the requirements under subparagraph 
(F) until such time as the food is sold by the 
owner, operator, or agent in charge of such 
fishing vessel. 
(D) COMMINGLED
RAW
AGRICULTURAL 
COMMODITIES.— 
(i) LIMITATION ON EXTENT OF TRAC-
ING.—Recordkeeping requirements under 
this subsection with regard to any commin-
gled raw agricultural commodity shall be 
limited to the requirements under subpara-
graph (F). 
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•AMDT. NO. 4805 
(ii) DEFINITIONS.—For the purposes 
of this subparagraph— 
(I) the term ‘‘commingled raw 
agricultural commodity’’ means any 
commodity that is combined or mixed 
after harvesting, but before proc-
essing; 
(II) the term ‘‘commingled raw 
agricultural commodity’’ shall not in-
clude types of fruits and vegetables 
that are raw agricultural commodities 
for which the Secretary has deter-
mined that standards promulgated 
under section 419 of the Federal 
Food, Drug, and Cosmetic Act (as 
added by section 6105) would mini-
mize the risk of serious adverse health 
consequences or death; and 
(III) 
the 
term 
‘‘processing’’ 
means operations that alter the gen-
eral state of the commodity, such as 
canning, cooking, freezing, dehydra-
tion, milling, grinding, pasteurization, 
or homogenization. 
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•AMDT. NO. 4805 
(E) EXEMPTION OF OTHER FOODS.—The 
Secretary may, by notice in the Federal Reg-
ister, modify the requirements under this sub-
section with respect to, or exempt a food or a 
type of facility from, the requirements of this 
subsection (other than the requirements under 
subparagraph (F), if applicable) if the Sec-
retary determines that product tracing require-
ments for such food (such as bulk or commin-
gled ingredients that are intended to be proc-
essed to destroy pathogens) or type of facility 
is not necessary to protect the public health. 
(F) RECORDKEEPING
REGARDING
PRE-
VIOUS
SOURCES
AND
SUBSEQUENT
RECIPI-
ENTS.—In the case of a person or food to which 
a limitation or exemption under subparagraph 
(C), (D), or (E) applies, if such person, or a 
person who manufactures, processes, packs, or 
holds such food, is required to register with the 
Secretary under section 415 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
350d) with respect to the manufacturing, proc-
essing, packing, or holding of the applicable 
food, the Secretary shall require such person to 
maintain records that identify the immediate 
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•AMDT. NO. 4805 
(ii) the sale is made by the owner, op-
erator, or agent in charge of such farm di-
rectly to a consumer or grocery store. 
(7) NO IMPACT ON NON-HIGH-RISK FOODS.— 
The recordkeeping requirements established under 
paragraph (1) shall have no effect on foods that are 
not designated by the Secretary under paragraph (2) 
as high-risk foods. Foods described in the preceding 
sentence shall be subject solely to the recordkeeping 
requirements under section 414 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 350c) and sub-
part J of part 1 of title 21, Code of Federal Regula-
tions (or any successor regulations). 
(e) EVALUATION AND RECOMMENDATIONS.— 
(1) REPORT.—Not later than 1 year after the 
effective date of the final rule promulgated under 
subsection (d)(1), the Comptroller General of the 
United States shall submit to Congress a report, 
taking into consideration the costs of compliance 
and other regulatory burdens on small businesses 
and Federal, State, and local food safety practices 
and requirements, that evaluates the public health 
benefits and risks, if any, of limiting— 
(A) the product tracing requirements 
under subsection (d) to foods identified under 
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•AMDT. NO. 4805 
paragraph (2) of such subsection, including 
whether such requirements provide adequate as-
surance of traceability in the event of inten-
tional adulteration, including by acts of ter-
rorism; and 
(B) the participation of restaurants in the 
recordkeeping requirements. 
(2) 
DETERMINATION
AND
RECOMMENDA-
TIONS.—In conducting the evaluation and report 
under paragraph (1), if the Comptroller General of 
the United States determines that the limitations de-
scribed in such paragraph do not adequately protect 
the public health, the Comptroller General shall sub-
mit to Congress recommendations, if appropriate, re-
garding recordkeeping requirements for restaurants 
and additional foods, in order to protect the public 
health. 
(f) FARMS.— 
(1) REQUEST
FOR
INFORMATION.—Notwith-
standing subsection (d), during an active investiga-
tion of a foodborne illness outbreak, or if the Sec-
retary determines it is necessary to protect the pub-
lic health and prevent or mitigate a foodborne illness 
outbreak, the Secretary, in consultation and coordi-
nation with State and local agencies responsible for 
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•AMDT. NO. 4805 
food safety, as appropriate, may request that the 
owner, operator, or agent of a farm identify poten-
tial immediate recipients, other than consumers, of 
an article of the food that is the subject of such in-
vestigation if the Secretary reasonably believes such 
article of food— 
(A) is adulterated under section 402 of the 
Federal Food, Drug, and Cosmetic Act; 
(B) presents a threat of serious adverse 
health consequences or death to humans or ani-
mals; and 
(C) was adulterated as described in sub-
paragraph (A) on a particular farm (as defined 
in section 1.227 of chapter 21, Code of Federal 
Regulations (or any successor regulation)). 
(2) MANNER OF REQUEST.—In making a re-
quest under paragraph (1), the Secretary, in con-
sultation and coordination with State and local agen-
cies responsible for food safety, as appropriate, shall 
issue a written notice to the owner, operator, or 
agent of the farm to which the article of food has 
been traced. The individual providing such notice 
shall present to such owner, operator, or agent ap-
propriate credentials and shall deliver such notice at 
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•AMDT. NO. 4805 
reasonable times and within reasonable limits and in 
a reasonable manner. 
(3) DELIVERY OF INFORMATION REQUESTED.— 
The owner, operator, or agent of a farm shall deliver 
the information requested under paragraph (1) in a 
prompt and reasonable manner. Such information 
may consist of records kept in the normal course of 
business, and may be in electronic or nonelectronic 
format. 
(4) LIMITATION.—A request made under para-
graph (1) shall not include a request for information 
relating to the finances, pricing of commodities pro-
duced, personnel, research, sales (other than infor-
mation relating to shipping), or other disclosures 
that may reveal trade secrets or confidential infor-
mation from the farm to which the article of food 
has been traced, other than information necessary to 
identify potential immediate recipients of such food. 
Section 301(j) of the Federal Food, Drug, and Cos-
metic Act and the Freedom of Information Act shall 
apply with respect to any confidential commercial in-
formation that is disclosed to the Food and Drug 
Administration in the course of responding to a re-
quest under paragraph (1). 
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•AMDT. NO. 4805 
(5) RECORDS.—Except with respect to identi-
fying potential immediate recipients in response to a 
request under this subsection, nothing in this sub-
section shall require the establishment or mainte-
nance by farms of new records. 
(g) NO LIMITATION ON COMMINGLING OF FOOD.— 
Nothing in this section shall be construed to authorize the 
Secretary to impose any limitation on the commingling of 
food. 
(h) SMALL ENTITY COMPLIANCE GUIDE.—Not later 
than 180 days after promulgation of a final rule under 
subsection (d), the Secretary shall issue a small entity 
compliance guide setting forth in plain language the re-
quirements of the regulations under such subsection in 
order to assist small entities, including farms and small 
businesses, in complying with the recordkeeping require-
ments under such subsection. 
(i) FLEXIBILITY FOR SMALL BUSINESSES.—Notwith-
standing any other provision of law, the regulations pro-
mulgated under subsection (d) shall apply— 
(1) to small businesses (as defined by the Sec-
retary in section 6103, not later than 90 days after 
the date of enactment of this Act) beginning on the 
date that is 1 year after the effective date of the 
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•AMDT. NO. 4805 
final regulations promulgated under subsection (d); 
and 
(2) to very small businesses (as defined by the 
Secretary in section 6103, not later than 90 days 
after the date of enactment of this Act) beginning 
on the date that is 2 years after the effective date 
of the final regulations promulgated under sub-
section (d). 
(j) ENFORCEMENT.— 
(1) PROHIBITED
ACTS.—Section 301(e) (21 
U.S.C. 331(e)) is amended by inserting ‘‘; or the vio-
lation of any recordkeeping requirement under sec-
tion 6204 of the FDA Food Safety Modernization 
Act (except when such violation is committed by a 
farm)’’ before the period at the end. 
(2) IMPORTS.—Section 801(a) (21 U.S.C. 
381(a)) is amended by inserting ‘‘or (4) the record-
keeping requirements under section 6204 of the 
FDA Food Safety Modernization Act (other than 
the requirements under subsection (f) of such sec-
tion) have not been complied with regarding such ar-
ticle,’’ in the third sentence before ‘‘then such article 
shall be refused admission’’. 
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•AMDT. NO. 4805 
SEC. 6205. SURVEILLANCE. 
(a) DEFINITION
OF FOODBORNE ILLNESS OUT-
BREAK.—In this Act, the term ‘‘foodborne illness out-
break’’ means the occurrence of 2 or more cases of a simi-
lar illness resulting from the ingestion of a certain food. 
(b) FOODBORNE
ILLNESS
SURVEILLANCE
SYS-
TEMS.— 
(1) 
IN
GENERAL.—The 
Secretary, 
acting 
through the Director of the Centers for Disease 
Control and Prevention, shall enhance foodborne ill-
ness surveillance systems to improve the collection, 
analysis, reporting, and usefulness of data on 
foodborne illnesses by— 
(A) coordinating Federal, State, and local 
foodborne illness surveillance systems, including 
complaint systems, and increasing participation 
in national networks of public health and food 
regulatory agencies and laboratories; 
(B) facilitating sharing of surveillance in-
formation on a more timely basis among gov-
ernmental agencies, including the Food and 
Drug Administration, the Department of Agri-
culture, the Department of Homeland Security, 
and State and local agencies, and with the pub-
lic; 
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•AMDT. NO. 4805 
(C) developing improved epidemiological 
tools for obtaining quality exposure data and 
microbiological methods for classifying cases; 
(D) augmenting such systems to improve 
attribution of a foodborne illness outbreak to a 
specific food; 
(E) expanding capacity of such systems, 
including working toward automatic electronic 
searches, for implementation of identification 
practices, including fingerprinting strategies, 
for foodborne infectious agents, in order to 
identify new or rarely documented causes of 
foodborne illness and submit standardized infor-
mation to a centralized database; 
(F) allowing timely public access to aggre-
gated, de-identified surveillance data; 
(G) at least annually, publishing current 
reports on findings from such systems; 
(H) establishing a flexible mechanism for 
rapidly initiating scientific research by academic 
institutions; 
(I) integrating foodborne illness surveil-
lance systems and data with other biosurveil-
lance and public health situational awareness 
capabilities at the Federal, State, and local lev-
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•AMDT. NO. 4805 
els, including by sharing foodborne illness sur-
veillance data with the National Biosurveillance 
Integration Center; and 
(J) other activities as determined appro-
priate by the Secretary. 
(2) WORKING
GROUP.—The Secretary shall 
support and maintain a diverse working group of ex-
perts and stakeholders from Federal, State, and 
local food safety and health agencies, the food and 
food testing industries, consumer organizations, and 
academia. Such working group shall provide the Sec-
retary, through at least annual meetings of the 
working group and an annual public report, advice 
and recommendations on an ongoing and regular 
basis regarding the improvement of foodborne illness 
surveillance and implementation of this section, in-
cluding advice and recommendations on— 
(A) the priority needs of regulatory agen-
cies, the food industry, and consumers for infor-
mation and analysis on foodborne illness and its 
causes; 
(B) opportunities to improve the effective-
ness of initiatives at the Federal, State, and 
local levels, including coordination and integra-
tion of activities among Federal agencies, and 
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•AMDT. NO. 4805 
among the Federal, State, and local levels of 
government; 
(C) improvement in the timeliness and 
depth of access by regulatory and health agen-
cies, the food industry, academic researchers, 
and consumers to foodborne illness aggregated, 
de-identified surveillance data collected by gov-
ernment agencies at all levels, including data 
compiled by the Centers for Disease Control 
and Prevention; 
(D) key barriers at Federal, State, and 
local levels to improving foodborne illness sur-
veillance and the utility of such surveillance for 
preventing foodborne illness; 
(E) the capabilities needed for establishing 
automatic electronic searches of surveillance 
data; and 
(F) specific actions to reduce barriers to 
improvement, implement the working group’s 
recommendations, and achieve the purposes of 
this section, with measurable objectives and 
timelines, and identification of resource and 
staffing needs. 
(3) AUTHORIZATION OF APPROPRIATIONS.—To 
carry out the activities described in paragraph (1), 
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•AMDT. NO. 4805 
there is authorized to be appropriated $24,000,000 
for each fiscal years 2011 through 2015. 
(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 foodborne illness outbreak re-
sponse and containment. 
(B) Accelerate foodborne 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 
safety and defense resources and reduce the in-
cidence of foodborne illness. 
(E) Share information on a timely basis 
among public health and food regulatory agen-
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•AMDT. NO. 4805 
cies, with the food industry, with health care 
providers, and with the public. 
(F) Strengthen the capacity of State and 
local agencies to achieve the goals described in 
section 6108. 
(2) REVIEW.—In developing of the strategies 
required by paragraph (1), the Secretary shall, not 
later than 1 year after the date of enactment of the 
FDA Food Safety Modernization Act, complete a re-
view of State and local capacities, and needs for en-
hancement, 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. 
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•AMDT. NO. 4805 
(d) FOOD SAFETY CAPACITY BUILDING GRANTS.— 
Section 317R(b) of the Public Health Service Act (42 
U.S.C. 247b–20(b)) is amended— 
(1) by striking ‘‘2002’’ and inserting ‘‘2010’’; 
and 
(2) by striking ‘‘2003 through 2006’’ and in-
serting ‘‘2011 through 2015’’. 
SEC. 6206. MANDATORY RECALL AUTHORITY. 
(a) IN GENERAL.—Chapter IV (21 U.S.C. 341 et 
seq.), as amended by section 6202, is amended by adding 
at the end the following: 
‘‘SEC. 423. MANDATORY RECALL AUTHORITY. 
‘‘(a) VOLUNTARY PROCEDURES.—If the Secretary 
determines, based on information gathered through the re-
portable food registry under section 417 or through any 
other means, that there is a reasonable probability that 
an article of food (other than infant formula) is adulter-
ated under section 402 or misbranded under section 
403(w) and the use of or exposure to such article will 
cause serious adverse health consequences or death to hu-
mans or animals, the Secretary shall provide the respon-
sible party (as defined in section 417) with an opportunity 
to cease distribution and recall such article. 
‘‘(b) PREHEARING ORDER TO CEASE DISTRIBUTION 
AND GIVE NOTICE.— 
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•AMDT. NO. 4805 
‘‘(1) IN GENERAL.—If the responsible party re-
fuses to or does not voluntarily cease distribution or 
recall such article within the time and in the manner 
prescribed by the Secretary (if so prescribed), the 
Secretary may, by order require, as the Secretary 
deems necessary, such person to— 
‘‘(A) immediately cease distribution of 
such article; and 
‘‘(B) as applicable, immediately notify all 
persons— 
‘‘(i) manufacturing, processing, pack-
ing, transporting, distributing, receiving, 
holding, or importing and selling such arti-
cle; and 
‘‘(ii) to which such article has been 
distributed, transported, or sold, to imme-
diately cease distribution of such article. 
‘‘(2) REQUIRED ADDITIONAL INFORMATION.— 
‘‘(A) IN GENERAL.—If an article of food 
covered by a recall order issued under para-
graph (1)(B) has been distributed to a ware-
house-based third-party logistics provider with-
out providing such provider sufficient informa-
tion to know or reasonably determine the pre-
cise identity of the article of food covered by a 
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•AMDT. NO. 4805 
recall order that is in its possession, the notice 
provided by the responsible party subject to the 
order issued under paragraph (1)(B) shall in-
clude such information as is necessary for the 
warehouse-based third-party logistics provider 
to identify the food. 
‘‘(B) RULES OF CONSTRUCTION.—Nothing 
in this paragraph shall be construed— 
‘‘(i) to exempt a warehouse-based 
third-party logistics provider from the re-
quirements of this Act, including the re-
quirements in this section and section 414; 
or 
‘‘(ii) to exempt a warehouse-based 
third party logistics provider from being 
the subject of a mandatory recall order. 
‘‘(3) DETERMINATION
TO
LIMIT
AREAS
AF-
FECTED.—If the Secretary requires a responsible 
party to cease distribution under paragraph (1)(A) 
of an article of food identified in subsection (a), the 
Secretary may limit the size of the geographic area 
and the markets affected by such cessation if such 
limitation would not compromise the public health. 
‘‘(c) HEARING ON ORDER.—The Secretary shall pro-
vide the responsible party subject to an order under sub-
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•AMDT. NO. 4805 
section (b) with an opportunity for an informal hearing, 
to be held as soon as possible, but not later than 2 days 
after the issuance of the order, on the actions required 
by the order and on why the article that is the subject 
of the order should not be recalled. 
‘‘(d) POST-HEARING RECALL ORDER AND MODIFICA-
TION OF ORDER.— 
‘‘(1) AMENDMENT OF ORDER.—If, after pro-
viding opportunity for an informal hearing under 
subsection (c), the Secretary determines that re-
moval of the article from commerce is necessary, the 
Secretary shall, as appropriate— 
‘‘(A) amend the order to require recall of 
such article or other appropriate action; 
‘‘(B) specify a timetable in which the recall 
shall occur; 
‘‘(C) require periodic reports to the 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) VACATING OF ORDER.—If, after such hear-
ing, the Secretary determines that adequate grounds 
do not exist to continue the actions required by the 
order, or that such actions should be modified, the 
Secretary shall vacate the order or modify the order. 
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•AMDT. NO. 4805 
‘‘(e) RULE REGARDING ALCOHOLIC BEVERAGES.— 
The Secretary shall not initiate a mandatory recall or take 
any other action under this section with respect to any 
alcohol beverage until the Secretary has provided the Alco-
hol and Tobacco Tax and Trade Bureau with a reasonable 
opportunity to cease distribution and recall such article 
under the Alcohol and Tobacco Tax and Trade Bureau 
authority. 
‘‘(f) COOPERATION AND CONSULTATION.—The Sec-
retary shall work with State and local public health offi-
cials in carrying out this section, as appropriate. 
‘‘(g) PUBLIC NOTIFICATION.—In conducting a recall 
under this section, the Secretary shall— 
‘‘(1) ensure that a press release is published re-
garding the recall, as well as alerts and public no-
tices, as appropriate, in order to provide notifica-
tion— 
‘‘(A) of the recall to consumers and retail-
ers to whom such article was, or may have 
been, distributed; and 
‘‘(B) that includes, at a minimum— 
‘‘(i) the name of the article of food 
subject to the recall; 
‘‘(ii) a description of the risk associ-
ated with such article; and 
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•AMDT. NO. 4805 
‘‘(iii) to the extent practicable, infor-
mation for consumers about similar arti-
cles of food that are not affected by the re-
call; 
‘‘(2) consult the policies of the Department of 
Agriculture regarding providing to the public a list 
of retail consignees receiving products involved in a 
Class I recall and shall consider providing such a list 
to the public, as determined appropriate by the Sec-
retary; and 
‘‘(3) if available, publish on the Internet Web 
site of the Food and Drug Administration an image 
of the article that is the subject of the press release 
described in paragraph (1). 
‘‘(h) NO DELEGATION.—The authority conferred by 
this section to order a recall or vacate a recall order shall 
not be delegated to any officer or employee other than the 
Commissioner. 
‘‘(i) EFFECT.—Nothing in this section shall affect the 
authority of the Secretary to request or participate in a 
voluntary recall, or to issue an order to cease distribution 
or to recall under any other provision of this Act or under 
the Public Health Service Act. 
‘‘(j) COORDINATED COMMUNICATION.— 
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•AMDT. NO. 4805 
‘‘(1) IN GENERAL.—To assist in carrying out 
the requirements of this subsection, the Secretary 
shall establish an incident command operation or a 
similar operation within the Department of Health 
and Human Services that will operate not later than 
24 hours after the initiation of a mandatory recall 
or the recall of an article of food for which the use 
of, or exposure to, such article will cause serious ad-
verse health consequences or death to humans or 
animals. 
‘‘(2) REQUIREMENTS.—To reduce the potential 
for miscommunication during recalls or regarding in-
vestigations of a foodborne illness outbreak associ-
ated with a food that is subject to a recall, each inci-
dent command operation or similar operation under 
paragraph (1) shall use regular staff and resources 
of the Department of Health and Human Services 
to— 
‘‘(A) ensure timely and coordinated com-
munication within the Department, including 
enhanced communication and coordination be-
tween different agencies and organizations with-
in the Department; 
‘‘(B) ensure timely and coordinated com-
munication from the Department, including 
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•AMDT. NO. 4805 
public statements, throughout the duration of 
the investigation and related foodborne illness 
outbreak; 
‘‘(C) identify a single point of contact 
within the Department for public inquiries re-
garding any actions by the Secretary related to 
a recall; 
‘‘(D) coordinate with Federal, State, local, 
and tribal authorities, as appropriate, that have 
responsibilities related to the recall of a food or 
a foodborne illness outbreak associated with a 
food that is subject to the recall, including noti-
fication of the Secretary of Agriculture and the 
Secretary of Education in the event such re-
called food is a commodity intended for use in 
a child nutrition program (as identified in sec-
tion 25(b) of the Richard B. Russell National 
School Lunch Act (42 U.S.C. 1769f(b)); and 
‘‘(E) conclude operations at such time as 
the Secretary determines appropriate. 
‘‘(3) MULTIPLE RECALLS.—The Secretary may 
establish multiple or concurrent incident command 
operations or similar operations in the event of mul-
tiple recalls or foodborne illness outbreaks necessi-
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•AMDT. NO. 4805 
tating such action by the Department of Health and 
Human Services.’’. 
(b) SEARCH ENGINE.—Not later than 90 days after 
the date of enactment of this Act, the Secretary shall mod-
ify the Internet Web site of the Food and Drug Adminis-
tration to include a search engine that— 
(1) is consumer-friendly, as determined by the 
Secretary; and 
(2) provides a means by which an individual 
may locate relevant information regarding each arti-
cle of food subject to a recall under section 423 of 
the Federal Food, Drug, and Cosmetic Act and the 
status of such recall (such as whether a recall is on-
going or has been completed). 
(c) CIVIL
PENALTY.—Section 303(f)(2)(A) (21 
U.S.C. 333(f)(2)(A)) is amended by inserting ‘‘or any per-
son who does not comply with a recall order under section 
423’’ after ‘‘section 402(a)(2)(B)’’. 
(d) PROHIBITED ACTS.—Section 301 (21 U.S.C. 331 
et seq.), as amended by section 6106, is amended by add-
ing at the end the following: 
‘‘(xx) The refusal or failure to follow an order under 
section 423.’’. 
(e) GAO REVIEW.— 
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•AMDT. NO. 4805 
‘‘(2) CONTENTS.—Each application submitted 
under paragraph (1) shall include— 
‘‘(A) an assurance that the eligible entity 
has developed plans to engage in the types of 
activities described in subsection (a); 
‘‘(B) a description of the types of activities 
to be funded by the grant; 
‘‘(C) an itemization of how grant funds re-
ceived under this section will be expended; 
‘‘(D) a description of how grant activities 
will be monitored; and 
‘‘(E) an agreement by the eligible entity to 
report information required by the Secretary to 
conduct evaluations under this section. 
‘‘(c) LIMITATIONS.—The funds provided under sub-
section (a) shall be available to an eligible entity that re-
ceives a grant under this section only to the extent such 
entity funds the food safety programs of such entity inde-
pendently of any grant under this section in each year of 
the grant at a level equal to the level of such funding in 
the previous year, increased by the Consumer Price Index. 
Such non-Federal matching funds may be provided di-
rectly or through donations from public or private entities 
and may be in cash or in-kind, fairly evaluated, including 
plant, equipment, or services. 
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•AMDT. NO. 4805 
lieved to be in violation of any provision of this Act, 
or any order, rule, regulation, standard, or ban 
under this Act. 
‘‘(b) PROCESS.— 
‘‘(1) IN GENERAL.—A person who believes that 
he or she has been discharged or otherwise discrimi-
nated against by any person in violation of sub-
section (a) may, not later than 180 days after the 
date on which such violation occurs, file (or have any 
person file on his or her behalf) a complaint with the 
Secretary of Labor (referred to in this section as the 
‘Secretary’) alleging such discharge or discrimina-
tion and identifying the person responsible for such 
act. Upon receipt of such a complaint, the Secretary 
shall notify, in writing, the person named in the 
complaint of the filing of the complaint, of the alle-
gations contained in the complaint, of the substance 
of evidence supporting the complaint, and of the op-
portunities that will be afforded to such person 
under paragraph (2). 
‘‘(2) INVESTIGATION.— 
‘‘(A) IN
GENERAL.—Not later than 60 
days after the date of receipt of a complaint 
filed under paragraph (1) and after affording 
the complainant and the person named in the 
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