‘‘(f) ADVANCE NOTICE.—Whenever analytical testing 
is conducted pursuant to subsection (a), the person on whose 
behalf the testing is conducted shall notify the Secretary be-
fore any sample of the article is collected. Such notice shall 
contain information the Secretary determines is appro-
priate 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.—When-
ever analytical testing is conducted pursuant to subsection 
(a), the laboratory conducting such testing shall submit, di-
rectly 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 ac-
credited by a recognized laboratory accreditation 
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) (relating to 
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analytical methods) on a laboratory or method basis due 
to exigent or other circumstances. 
‘‘(i) 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: 
‘‘(pp)(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: 
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‘‘SEC. 420. NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED FOOD. 
‘‘(a) NOTIFICATION, NONDISTRIBUTION, AND RECALL 
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(r) that has reason 
to believe that an article of food when introduced into 
or while in interstate commerce, or while held for sale 
(regardless of whether the first sale) after shipment in 
interstate commerce, is adulterated or misbranded in 
a manner that presents a reasonable probability that 
the use or consumption of, or exposure to, the article 
(or an ingredient or component used in any such ar-
ticle) will cause a threat of serious adverse health con-
sequences or death to humans or animals shall, as 
soon as practicable, notify the Secretary of the iden-
tity 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 request 
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 voluntarily— 
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‘‘(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 ad-
verse health consequences or death to humans or animals, 
the Secretary shall have the authority to issue an order re-
quiring any person who distributes such article to imme-
diately cease distribution of such article. 
‘‘(d) ACTION FOLLOWING ORDER.—Any person who is 
subject to an order under subsection (c) shall immediately 
cease distribution of such article and provide notification 
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 undertaken voluntarily 
by the person, including after a request under subsection 
(b). Except as provided in subsection (f), an informal hear-
ing 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 parties joint-
ly agree to an extension. After affording an opportunity for 
an informal hearing, the Secretary shall determine whether 
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the order should be amended to require a recall of such arti-
cle. If, after providing an opportunity for such a hearing, 
the Secretary determines that inadequate 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 
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local officials, or other individuals designated by the 
Secretary. 
‘‘(3) 
NONDELEGATION.—An 
amended 
order 
under this subsection shall be ordered by the Secretary 
or an official designated by the Secretary. An official 
may not be so designated unless the official is the di-
rector of the district under this Act in which the arti-
cle involved is located, or is an official senior to such 
director. 
‘‘(f) EMERGENCY RECALL ORDER.— 
‘‘(1) IN GENERAL.—If the Secretary has a rea-
sonable belief that an article of food subject to an 
order under subsection (c) presents an imminent 
threat of serious adverse health consequences or death 
to humans or animals, the Secretary may issue an 
order requiring any person who distributes such arti-
cle— 
‘‘(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 
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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 cal-
endar 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 deter-
mine whether the order should be amended pursuant 
to subsection (e)(1). If, after providing an oppor-
tunity for such a hearing, the Secretary determines 
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 Regulatory 
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 sec-
tion to consumers to whom the article was, or may have 
been, distributed and to appropriate State and local health 
officials. 
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‘‘(h) SAVINGS CLAUSE.—Nothing contained in this sec-
tion 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 Service 
Act.’’. 
(c) ARTICLES SUBJECT TO REFUSAL.—The third sen-
tence 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 arti-
cle shall be refused admission’’. 
(d) EFFECTIVE DATE.—Sections 301(pp)(1) and 420 
of the Federal Food, Drug, and Cosmetic Act, as added by 
subsections (a) and (b), shall apply with respect to articles 
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. 
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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 para-
graph (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; 
‘‘(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 section 
1.227(b)(3) of title 21, Code of Federal Regula-
tions, or successor regulations) at which such 
food is produced for sale or distribution in inter-
state 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 regula-
tions) at which such food is offered for sale; or 
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‘‘(D) a person that is required to register 
pursuant to section 801(r) with respect to impor-
tation of such food.’’; 
(2) in subsection (b), by adding at the end the 
following: 
‘‘(3) REPORTING BY RESTAURANTS AND RETAIL 
FOOD
ESTABLISHMENTS.—In addition to the elec-
tronic portal described in paragraph (1), the Sec-
retary shall make available alternative means of re-
porting under this section with respect to restaurants 
and other retail food establishments with limited abil-
ity 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 
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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; 
‘‘(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 compo-
nent 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 article; and’’; 
and 
(4) in subsection (e)— 
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(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— 
(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 section, 
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 informa-
tion relating to food that is exempt from disclosure pursu-
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ant to section 552(a) of title 5, United States Code, by rea-
son of subsection (b)(4) of such section, or that is referred 
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 
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 infor-
mation to the person is appropriate under the cir-
cumstances and the recipient provides adequate assurances 
to the Secretary that the recipient will preserve the con-
fidentiality 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 section, 
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 hav-
ing responsibility— 
‘‘(i) to facilitate global or regional harmoni-
zation of standards and requirements in an area 
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of responsibility of the Food and Drug Adminis-
tration; or 
‘‘(ii) to promote and coordinate public 
health efforts, 
if the agency or organization provides adequate assur-
ances to the Secretary that the agency or organization 
will preserve the confidentiality of the information. 
‘‘(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 determines 
that such disclosure is necessary to protect the public 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 organization 
has requested that the information be kept confidential, or 
has precluded such disclosure under other use limitations, 
as a condition of providing the information. 
‘‘(e) Nothing in subsection (d) authorizes the Secretary 
to withhold information from the Congress or prevents the 
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Secretary from complying with an order of a court of the 
United States. 
‘‘(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 a program that facilitates the move-
ment 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; 
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‘‘(2) ensures that appropriate safety and security 
controls are in place throughout the supply chain for 
such food; and 
‘‘(3) provides supporting information to the Sec-
retary. 
‘‘(b) GUIDELINES.— 
‘‘(1) DEVELOPMENT.—For purposes of the pro-
gram established under subsection (a), the Secretary 
shall develop safety and security guidelines applicable 
to the importation of food. 
‘‘(2) FACTORS.—Such guidelines shall take into 
account the following factors: 
‘‘(A) The personnel of the person importing 
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. 
‘‘(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 de-
termines necessary.’’. 
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SEC. 114. INFANT FORMULA. 
(a) MISBRANDING.—Section 403 of the Federal Food, 
Drug, and Cosmetic Act (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 it is not the 
subject of a letter from the Secretary provided pursuant to 
section 412(c)(1)(C).’’. 
(b) REQUIREMENTS.—Section 412 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 350a) is amended— 
(1) in subsection (b)(1), by adding at the end the 
following: ‘‘The quality factor requirements estab-
lished under this paragraph may include require-
ments for one or more clinical studies to demonstrate 
that the new infant formula supports normal physical 
growth of infants.’’; 
(2) in subsection (b)(4), by amending subpara-
graph (B) to read as follows: 
‘‘(B) Records required under subparagraph (A) with 
respect to an infant formula shall be retained for at least 
one year after the expiration of the shelf life of such infant 
formula. Such records shall be made available to the Sec-
retary for review and duplication upon request of the Sec-
retary.’’; 
(3) in subsection (c)(1)— 
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(A) in subparagraph (A), by striking ‘‘and’’ 
at the end; 
(B) in subparagraph (B), by striking 
‘‘(c)(1).’’ at the end and inserting ‘‘(d)(1), and’’; 
and 
(C) by adding at the end the following: 
‘‘(C) the Secretary has by letter informed such 
person that the registration requirements and the re-
quirements in subsection (d)(1) have been satisfied.’’; 
and 
(4) in subsection (d)(1), by striking subpara-
graphs (C) and (D) and inserting the following: 
‘‘(C) scientific evidence and other evidence, as 
identified in regulations promulgated by the Sec-
retary, that demonstrates that the infant formula sat-
isfies the requirements of subsection (b)(1), and, as 
demonstrated by the testing required under subsection 
(b)(3), that it satisfies the requirements of subsection 
(i), and 
‘‘(D) scientific evidence and other evidence, as 
identified in regulations promulgated by the Sec-
retary, that demonstrate that the processing of the in-
fant formula complies with the requirements of sub-
section (b)(2).’’. 
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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 similar 
illness resulting from the ingestion of a food. 
(b) FOOD-BORNE
ILLNESS
SURVEILLANCE
SYS-
TEMS.—The Secretary, acting through the Director of the 
Centers for Disease Control and Prevention, shall enhance 
food-borne illness surveillance systems to improve the collec-
tion, analysis, reporting, 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-
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 microbiological 
methods for classifying cases; 
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(4) augmenting such systems to improve attribu-
tion 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 institutions; 
(9) integrating food-borne illness surveillance 
systems and data with other biosurveillance and pub-
lic 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 CAPACITY 
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: 
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(A) Improve food-borne illness outbreak re-
sponse and containment. 
(B) Accelerate food-borne illness surveillance 
and outbreak investigation, including rapid 
shipment of clinical isolates from clinical labora-
tories to appropriate State laboratories, and con-
ducting more standardized illness outbreak inter-
views. 
(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 inci-
dence 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 of 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 sur-
vey with respect to— 
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(A) staffing levels and expertise available to 
perform food safety and defense functions; 
(B) laboratory capacity to support surveil-
lance, outbreak response, inspection, and enforce-
ment 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. 
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 pro-
gram 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 dietary 
choices; 
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(2) information to health professionals so that 
they may improve diagnosis and treatment of food-re-
lated illness and advise individuals whose health con-
ditions place them in particular risk; and 
(3) such other information or advice to con-
sumers and other persons as the Secretary determines 
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 
(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; 
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