agent shall have access to the information re-
quired to be maintained under section 414(d) 
for food that is manufactured, processed, 
packed, or held at the facility. 
‘‘(F) If the facility is located outside of the 
United States, the name, address, and emer-
gency contact information for a United States 
agent. 
‘‘(G) The unique facility identifier of the 
facility, as specified under section 911. 
‘‘(H) Such additional information per-
taining to the facility as the Secretary may re-
quire by regulation. 
The registrant shall notify the Secretary of any 
change in the submitted information not later than 
30 days after the date of such change, unless other-
wise specified by the Secretary.’’. 
(3) SUSPENSION AND CANCELLATION AUTHOR-
ITY.—Section 415(a) (21 U.S.C. 350d(a)), as 
amended by paragraphs (1) and (2), is further 
amended by adding at the end the following: 
‘‘(5) SUSPENSION OF REGISTRATION.— 
‘‘(A) IN
GENERAL.—The Secretary may 
suspend the registration of any facility reg-
istered under this section for a violation of this 
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Act that could result in serious adverse health 
consequences or death to humans or animals. 
‘‘(B) NOTICE
OF
SUSPENSION.—Suspen-
sion of a registration shall be preceded by— 
‘‘(i) notice to the facility of the intent 
to suspend the registration; and 
‘‘(ii) an opportunity for an informal 
hearing, as defined in guidance or regula-
tions issued by the Secretary, concerning 
the suspension of such registration for 
such facility. 
‘‘(C) REQUEST.—The owner, operator, or 
agent in charge of a facility whose registration 
is suspended may request that the Secretary va-
cate the suspension of registration when such 
owner, operator, or agent has corrected the vio-
lation that is the basis for such suspension. 
‘‘(D) 
VACATING
OF
SUSPENSION.—If, 
based on an inspection of the facility or other 
information, the Secretary determines that ade-
quate reasons do not exist to continue the sus-
pension of a registration, the Secretary shall va-
cate such suspension. 
‘‘(6) CANCELLATION OF REGISTRATION.— 
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‘‘(A) IN GENERAL.—Not earlier than 10 
days after providing the notice under subpara-
graph (B), the Secretary may cancel a registra-
tion that the Secretary determines was not up-
dated in accordance with this section or other-
wise contains false, incomplete, or inaccurate 
information. 
‘‘(B) NOTICE
OF
CANCELLATION.—Can-
cellation shall be preceded by notice to the facil-
ity of the intent to cancel the registration and 
the basis for such cancellation. 
‘‘(C) TIMELY UPDATE OR CORRECTION.— 
If the registration for the facility is updated or 
corrected no later than 7 days after notice is 
provided under subparagraph (B), the Sec-
retary shall not cancel such registration. 
‘‘(7) REPORT TO CONGRESS.—Not later than 
March 30th of each year, the Secretary shall submit 
to the Congress a report, based on the registrations 
on or before December 31 of the previous year, on 
the following: 
‘‘(A) The number of facilities registered 
under this section. 
‘‘(B) The number of such facilities that are 
domestic. 
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‘‘(C) The number of such facilities that are 
foreign. 
‘‘(D) The number of such facilities that 
are high-risk. 
‘‘(E) The number of such facilities that are 
low-risk. 
‘‘(F) The number of such facilities that 
hold food.’’. 
(c) REGISTRATION FEE.—Chapter VII (21 U.S.C. 
371 et seq.) is amended by adding at the end of sub-
chapter C the following: 
‘‘PART 6—FEES RELATING TO FOOD 
‘‘SEC. 743. FACILITY REGISTRATION FEE. 
‘‘(a) IN GENERAL.— 
‘‘(1) ASSESSMENT
AND
COLLECTION.—Begin-
ning in fiscal year 2010, the Secretary shall assess 
and collect an annual fee for the registration of a fa-
cility under section 415. 
‘‘(2) PAYABLE DATE.—A fee under this section 
shall be payable— 
‘‘(A) for a facility that was not registered 
under section 415 for the preceding fiscal year, 
on the date of registration; and 
‘‘(B) for any other facility— 
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‘‘(i) for fiscal year 2010, not later 
than the sooner of 90 days after the date 
of the enactment of this part or December 
31, 2009; and 
‘‘(ii) for a subsequent fiscal year, not 
later than December 31 of such fiscal year. 
‘‘(b) FEE AMOUNTS.— 
‘‘(1) IN GENERAL.—The registration fee under 
subsection (a) shall be— 
‘‘(A) for fiscal year 2010, $1,000; and 
‘‘(B) for fiscal year 2011 and each subse-
quent fiscal year, the fee for fiscal year 2010 as 
adjusted under subsection (c). 
‘‘(2) ANNUAL
FEE
SETTING.—The Secretary 
shall, not later than 60 days before the start of fis-
cal year 2011 and each subsequent fiscal year, es-
tablish, for the next fiscal year, registration fees 
under subsection (a), as described in paragraph (1). 
‘‘(c) INFLATION ADJUSTMENT.—For fiscal year 2011 
and each subsequent fiscal year, the fee amount under 
subsection (b) shall be adjusted by the Secretary by notice, 
published in the Federal Register, to reflect the greater 
of— 
‘‘(1) the total percentage change that occurred 
in the Consumer Price Index for all urban con-
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sumers (all items; U.S. city average) for the 12- 
month period ending June 30 preceding the fiscal 
year for which fees are being established; 
‘‘(2) the total percentage change for the pre-
vious fiscal year in basic pay under the General 
Schedule in accordance with section 5332 of title 5, 
United States Code, as adjusted by any locality- 
based comparability payment pursuant to section 
5304 of such title for Federal employees stationed in 
the District of Columbia; or 
‘‘(3) the average annual change in the cost, per 
full-time equivalent position of the Food and Drug 
Administration, of all personnel compensation and 
benefits paid with respect to such positions for the 
first 5 years of the preceding 6 fiscal years. 
The adjustment made each fiscal year under this sub-
section shall be added on a compounded basis to the sum 
of all adjustments made each fiscal year after fiscal year 
2010 under this subsection. 
‘‘(d) LIMITATIONS.— 
‘‘(1) IN GENERAL.—Fees under subsection (a) 
shall be refunded for a fiscal year beginning after 
fiscal year 2010 unless appropriations for salaries 
and expenses of the Food and Drug Administration 
for such fiscal year (excluding the amount of fees 
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appropriated for such fiscal year) are equal to or 
greater than the amount of appropriations for the 
salaries and expenses of the Food and Drug Admin-
istration for fiscal year 2010 (excluding the amount 
of fees appropriated for such fiscal year) multiplied 
by the adjustment factor applicable to the fiscal year 
involved. 
‘‘(2) AUTHORITY.—If the Secretary does not 
assess fees under subsection (a) during any portion 
of a fiscal year because of paragraph (1) and if at 
a later date in such fiscal year the Secretary may as-
sess such fees, the Secretary may assess and collect 
such fees, without any modification in the rate, for 
registration under section 415 at any time in such 
fiscal year. 
‘‘(3) ADJUSTMENT
FACTOR.—In this sub-
section, the term ‘adjustment factor’ applicable to a 
fiscal year is the Consumer Price Index for all urban 
consumers (all items; United States city average) for 
October of the preceding fiscal year divided by such 
Index for October 2009. 
‘‘(e) 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 
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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 of food safety activities. 
‘‘(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. 
‘‘(f) COLLECTION OF UNPAID FEES.—In any case 
where the Secretary does not receive payment of a fee as-
sessed under subsection (a) within 30 days after it is due, 
such fee shall be treated as a claim of the United States 
Government subject to subchapter II of chapter 37 of title 
31, United States Code. 
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‘‘(g) CONSTRUCTION.—This section may not be con-
strued to require that the number of full-time equivalent 
positions in the Department of Health and Human Serv-
ices, for officers, employers, and advisory committees not 
engaged in food safety activities, be reduced to offset the 
number of officers, employees, and advisory committees so 
engaged. 
‘‘(h) ANNUAL FISCAL REPORTS.—Beginning with 
fiscal year 2011, not later than 120 days after the end 
of each fiscal year for which fees are collected under this 
section, the Secretary shall prepare and submit to the 
Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, 
Labor, and Pensions of the Senate a report on the imple-
mentation of the authority for such fees during such fiscal 
year and the use, by the Food and Drug Administration, 
of the fees collected for such fiscal year. 
‘‘(i) DEFINITIONS.—In this section: 
‘‘(1) The term ‘costs of food safety activities’ 
means the expenses incurred in connection with food 
safety activities for— 
‘‘(A) officers and employees of the Food 
and Drug Administration, contractors of the 
Food and Drug Administration, advisory com-
mittees, and costs related to such officers, em-
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ployees, and committees and to contracts with 
such contractors; 
‘‘(B) laboratory capacity; 
‘‘(C) management of information, and the 
acquisition, maintenance, and repair of tech-
nology resources; 
‘‘(D) leasing, maintenance, renovation, and 
repair of facilities and acquisition, maintenance, 
and repair of fixtures, furniture, scientific 
equipment, and other necessary materials and 
supplies; and 
‘‘(E) collecting fees under this section and 
accounting for resources allocated for food safe-
ty activities. 
‘‘(2) The term ‘food safety activities’ means ac-
tivities related to compliance by facilities registered 
under section 415 with the requirements of this Act 
relating to food (including research related to and 
the development of standards (such as performance 
standards and preventive controls), risk assessments, 
hazard analyses, inspection planning and inspec-
tions, third-party inspections, compliance review and 
enforcement, import review, information technology 
support, test development, product sampling, risk 
communication, and administrative detention).’’. 
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(d) TRANSITIONAL PROVISIONS.— 
(1) FEES.—The Secretary of Health and 
Human Services shall first impose the fee estab-
lished under section 743 of the Federal Food, Drug, 
and Cosmetic Act, as added by subsection (c), for 
fiscal years beginning with fiscal year 2010. 
(2) MODIFICATION OF REGISTRATION FORM.— 
Not later than 180 days after the date of the enact-
ment of this Act, the Secretary of Health and 
Human Services shall modify the registration form 
under section 415 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 350d) to comply with the 
amendments made by this section. 
(3) APPLICATION.—The amendments made by 
this section, other than subsections (b)(2) and (c), 
shall take effect on the date that is 30 days after 
the date on which such modified registration form 
takes effect, but not later than 210 days after the 
date of the enactment of this Act. 
(4) SUNSET DATE.—Section 743 of the Federal 
Food, Drug, and Cosmetic Act, as added by sub-
section (c), does not authorize the assessment or col-
lection of a fee for registration under section 415 of 
such Act (21 U.S.C. 360) occurring after fiscal year 
2014. 
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SEC. 102. HAZARD ANALYSIS, RISK-BASED PREVENTIVE 
CONTROLS, AND FOOD SAFETY PLAN. 
(a) ADULTERATED FOOD.—Section 402 (21 U.S.C. 
342) is amended by adding at the end the following: 
‘‘(j) If it has been manufactured, processed, packed, 
transported, or held under conditions that do not meet the 
requirements of sections 418 and 418A.’’. 
(b) REQUIREMENTS.—Chapter IV (21 U.S.C. 341 et 
seq.) is amended by adding at the end the following: 
‘‘SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVEN-
TIVE CONTROLS. 
‘‘(a) IN GENERAL.—The owner, operator, or agent 
of a facility shall, in accordance with this section— 
‘‘(1) conduct a hazard analysis (or more than 
one if appropriate); 
‘‘(2) identify, implement, and validate effective 
preventive controls; 
‘‘(3) monitor preventive controls; 
‘‘(4) institute corrective actions when moni-
toring shows that preventive controls have not been 
properly implemented or were ineffective; 
‘‘(5) conduct verification activities; 
‘‘(6) maintain records of monitoring, corrective 
action, and verification; and 
‘‘(7) reanalyze for hazards. 
‘‘(b) IDENTIFICATION OF HAZARDS.— 
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‘‘(1) IN
GENERAL.—The owner, operator, or 
agent of a facility shall evaluate whether there are 
any hazards, including hazards due to the source of 
the ingredients, that are reasonably likely to occur 
in the absence of preventive controls that may affect 
the safety, wholesomeness, or sanitation of the food 
manufactured, processed, packed, transported, or 
held by the facility, including— 
‘‘(A) biological, chemical, physical, and ra-
diological hazards, natural toxins, pesticides, 
drug residues, filth, decomposition, parasites, 
allergens, and unapproved food and color addi-
tives; and 
‘‘(B) hazards that occur naturally, may be 
unintentionally introduced, or may be inten-
tionally introduced, including by acts of ter-
rorism. 
‘‘(2) IDENTIFIED
BY
THE
SECRETARY.—The 
Secretary may, by regulation or guidance, identify 
hazards that are reasonably likely to occur in the ab-
sence of preventive controls. 
‘‘(3) HAZARD ANALYSIS.—The owner, operator, 
or agent of a facility shall identify and describe the 
hazards evaluated under paragraph (1) or identified 
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under paragraph (2), to the extent applicable to the 
facility, in a hazard analysis. 
‘‘(c) PREVENTIVE CONTROLS.— 
‘‘(1) IN
GENERAL.—The owner, operator, or 
agent of a facility shall identify, implement, and vali-
date effective preventive controls to prevent, elimi-
nate, or reduce to acceptable levels the occurrence of 
any hazards identified in the hazard analysis under 
subsection (b)(3). 
‘‘(2) IDENTIFIED
BY
THE
SECRETARY.—The 
Secretary may establish by regulation or guidance 
preventive controls for specific product types to pre-
vent intentional or unintentional contamination 
throughout the supply chain. The owner, operator, 
or agent of a facility shall implement any preventive 
controls identified by the Secretary under this para-
graph. 
‘‘(d) MONITORING.—The owner, operator, or agent of 
a facility shall monitor the implementation of preventive 
controls under subsection (c) to identify any circumstances 
in which the preventive controls are not fully implemented 
or were ineffective, including through the use of environ-
mental and product testing programs, as appropriate. 
‘‘(e) CORRECTIVE ACTIONS.—The owner, operator, 
or agent of a facility shall establish and implement proce-
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dures to ensure that, if the preventive controls under sub-
section (c) are not fully implemented or are not effective— 
‘‘(1) no product from such facility enters com-
merce; and 
‘‘(2) appropriate action is taken to reduce the 
likelihood of recurrence of the implementation fail-
ure. 
‘‘(f) VERIFICATION.—The owner, operator, or agent 
of a facility shall ensure that— 
‘‘(1) the preventive controls identified under 
subsection (c) have been validated as adequate to 
control the hazards identified in the hazard analysis 
under subsection (b)(3); 
‘‘(2) the facility is conducting monitoring in ac-
cordance with subsection (d); 
‘‘(3) the facility is taking effective corrective ac-
tions under subsection (e); and 
‘‘(4) the preventive controls are effectively pre-
venting, eliminating, or reducing to an acceptable 
level the occurrence of identified hazards, including 
through the use of environmental and product test-
ing programs and other appropriate means. 
‘‘(g) REQUIREMENT TO REANALYZE AND REVISE.— 
‘‘(1) HAZARD ANALYSIS.—The owner, operator, 
or agent of a facility shall review the evaluation 
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under subsection (b) for the facility and, as nec-
essary, revise the hazard analysis under subsection 
(b)(3) for the facility not less than every 2 years. 
‘‘(2) PREVENTIVE
CONTROLS.—If there is a 
change that could affect the hazard analysis for a 
facility under subsection (b)(3) or if the Secretary 
determines that it is appropriate to protect public 
health, the owner, operator, or agent of the facility 
shall revise the preventive controls under subsection 
(c) for the facility to ensure that all hazards that are 
reasonably likely to occur are prevented, eliminated, 
or reduced to an acceptable level, or document the 
basis for the conclusion that no such revision is 
needed. 
‘‘(h) RECORDKEEPING.—The owner, operator, or 
agent of a facility shall maintain, for not less than 2 years, 
records documenting the activities described in subsections 
(a) through (g). 
‘‘(i) DEFINITIONS.—For purposes of this section: 
‘‘(1) FACILITY.—The term ‘facility’ means a 
domestic facility or a foreign facility that is required 
to be registered under section 415. 
‘‘(2) PREVENTIVE CONTROLS.—The term ‘pre-
ventive controls’ means those risk-based procedures, 
practices, and processes that a person knowledgeable 
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about the safe manufacturing, processing, packing, 
transporting, or holding of food would employ to 
prevent, eliminate, or reduce to an acceptable level 
the hazards identified in the hazard analysis under 
subsection (b)(3) and that are consistent with the 
current scientific understanding of safe food manu-
facturing, processing, packing, transporting, or hold-
ing at the time of the analysis. Those procedures, 
practices, and processes shall include the following, 
as appropriate: 
‘‘(A) Sanitation procedures and practices. 
‘‘(B) Supervisor, manager, and employee 
hygiene training. 
‘‘(C) Process controls. 
‘‘(D) An allergen control program to mini-
mize potential allergic reactions in humans 
from ingestion of, or contact with, human and 
animal food. 
‘‘(E) Good manufacturing practices. 
‘‘(F) Verification procedures, practices, 
and processes for suppliers and incoming ingre-
dients, which may include onsite auditing of 
suppliers and testing of incoming ingredients. 
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‘‘(G) Other procedures, practices, and 
processes established by the Secretary under 
subsection (c)(2). 
‘‘(3) REASONABLY
LIKELY
TO
OCCUR.—The 
term ‘reasonably likely to occur’ means a hazard for 
which a prudent person who, as applicable, manufac-
tures, processes, packs, transports, or holds food 
would establish controls because experience, illness 
data, scientific reports, or other information provide 
a basis to conclude that there is a reasonable possi-
bility that, in the absence of those controls, the haz-
ard will occur in the type of food being manufac-
tured, processed, packed, transported, or held. 
‘‘SEC. 418A. FOOD SAFETY PLAN. 
‘‘(a) IMPLEMENTATION OF FOOD SAFETY PLAN.— 
‘‘(1) IN GENERAL.—Before a facility (as de-
fined in section 418(i)) introduces or delivers for in-
troduction into interstate commerce any shipment of 
food, the owner, operator, or agent of the facility 
shall develop and implement a written food safety 
plan (in this section referred to as a ‘food safety 
plan’). 
‘‘(2) CONTENTS.—The food safety plan shall in-
clude each of the following elements: 
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‘‘(H) A description of the facility’s proce-
dures for tracing the distribution history of ar-
ticles of food, whether voluntarily or when re-
quired under section 414. 
‘‘(I) A description of the facility’s proce-
dures to ensure a safe and secure supply chain 
for the ingredients or components used in mak-
ing the food manufactured, processed, packed, 
transported, or held by such facility. 
‘‘(J) A description of the facility’s proce-
dures to implement the science-based perform-
ance standards issued under section 419.’’. 
(c) GUIDANCE OR REGULATIONS.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this subsection as 
the ‘‘Secretary’’) shall issue guidance or promulgate 
regulations to establish science-based standards for 
conducting a hazard analysis, documenting hazards, 
identifying and implementing preventive controls, 
and documenting the implementation of the preven-
tive controls, including verification and corrective ac-
tions under sections 418 and 418A of the Federal 
Food, Drug, and Cosmetic Act (as added by sub-
section (b)). 
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(2) CONSIDERATION.—In issuing guidance or 
promulgating regulations under this section, the Sec-
retary shall consider the impact of such guidance or 
regulations on small businesses. 
(d) NO EFFECT ON EXISTING HACCP AUTHORI-
TIES.—Nothing in this section or the amendments made 
by this section limits the authority of the Secretary under 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 
et seq.) or the Public Health Service Act (42 U.S.C. 201 
et seq.), as in effect on the day before the date of the 
enactment of this Act, to revise, issue, or enforce product- 
and category-specific regulations, such as the Seafood 
Hazard Analysis Critical Controls Points Program, the 
Juice Hazard Analysis Critical Control Program, and the 
Thermally Processed Low-Acid Foods Packaged in Her-
metically Sealed Containers standards. 
(e) EFFECTIVE DATE.— 
(1) GENERAL RULE.—The amendments made 
by this section shall take effect 18 months after the 
date of the enactment of this Act. 
(2) EXCEPTIONS.—Notwithstanding paragraph 
(1)— 
(A) the amendments made by this section 
shall apply to a small business (as defined by 
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the Secretary) after the date that is 2 years 
after the date of the enactment of this Act; and 
(B) the amendments made by this section 
shall apply to a very small business (as defined 
by the Secretary) after the date that is 3 years 
after the date of the enactment of this Act. 
SEC. 103. PERFORMANCE STANDARDS. 
(a) ADULTERATED FOOD.—Section 402 (21 U.S.C. 
342), as amended by section 102(a), is amended by adding 
at the end the following: 
‘‘(k) If it has been manufactured, processed, packed, 
transported, or held under conditions that do not meet the 
standards issued under section 419.’’. 
(b) REQUIREMENTS.—Chapter IV (21 U.S.C. 341 et 
seq.), as amended by section 102(b), is further amended 
by adding at the end the following: 
‘‘SEC. 419. PERFORMANCE STANDARDS. 
‘‘The Secretary shall, not less frequently than every 
2 years, review and evaluate epidemiological data and 
other appropriate sources of information, including re-
search under section 123 of the Food Safety Enhancement 
Act of 2009, to identify the most significant food-borne 
contaminants and the most significant resulting hazards. 
The Secretary shall issue, as soon as practicable, through 
guidance or by regulation, science-based performance 
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standards (which may include action levels) applicable to 
foods or food classes, as appropriate to minimize to an 
acceptable level, prevent, or eliminate the occurrence of 
such hazards. Such standards shall be applicable to foods 
and food classes.’’. 
(c) REPORT TO CONGRESS.—The Secretary of Health 
and Human Services shall submit to the Congress by 
March 30th of the year following each review under sec-
tion 419 of the Federal Food, Drug, and Cosmetic Act, 
as added by subsection (b), a report on the results of such 
review and the Secretary’s plans to address the significant 
food-borne hazards identified, or the basis for not address-
ing any significant food-borne hazards identified, includ-
ing any resource limitations or limitations in data that 
preclude further action at that time. 
SEC. 104. SAFETY STANDARDS FOR FRESH PRODUCE AND 
CERTAIN OTHER RAW AGRICULTURAL COM-
MODITIES. 
(a) ADULTERATED FOOD.—Section 402 (21 U.S.C. 
342), as amended by sections 102(a) and 103(a), is 
amended by adding at the end the following: 
‘‘(l) If it has been grown, harvested, packed, sorted, 
transported, or held under conditions that do not meet the 
standards established under section 419A.’’. 
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(b) STANDARDS.—Chapter IV (21 U.S.C. 341 et 
seq.), as amended by sections 102(b) and 103(b), is 
amended by adding at the end the following: 
‘‘SEC. 419A. SAFETY STANDARDS FOR PRODUCE AND CER-
TAIN OTHER RAW AGRICULTURAL COMMOD-
ITIES. 
‘‘(a) STANDARDS.—The Secretary shall establish by 
regulation science-based standards for the safe growing, 
harvesting, packing, sorting, transporting, and holding of 
raw agricultural commodities that— 
‘‘(1) are from a plant or a fungus; and 
‘‘(2) for which the Secretary has determined 
that such standards minimize the risk of serious ad-
verse health consequences or death to humans or 
animals. 
‘‘(b) CONTENTS.—The regulations under subsection 
(a)— 
‘‘(1) may set forth such procedures, processes, 
and practices as the Secretary determines to be rea-
sonably necessary— 
‘‘(A) to prevent the introduction of known 
or reasonably foreseeable biological, chemical, 
and physical hazards, including hazards that 
occur naturally, may be unintentionally intro-
duced, or may be intentionally introduced, in-
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cluding by acts of terrorism, into raw agricul-
tural commodities that are from a plant or a 
fungus; and 
‘‘(B) to provide reasonable assurances that 
such commodity is not adulterated under sec-
tion 402; 
‘‘(2) may include, with respect to growing, har-
vesting, packing, sorting, transporting, and storage 
operations, minimum standards for safety as the 
Secretary determines to be reasonably necessary; 
‘‘(3) may include standards addressing manure 
use, water quality, employee hygiene, sanitation and 
animal control, and temperature controls, as the 
Secretary determines to be reasonably necessary; 
‘‘(4) may include standards for such other ele-
ments as the Secretary determines necessary to 
carry out subsection (a); 
‘‘(5) shall provide a reasonable period of time 
for compliance, taking into account the needs of 
small businesses for additional time to comply; and 
‘‘(6) may provide for coordination of education 
and enforcement activities. 
‘‘(c) ENFORCEMENT.—The Secretary may coordinate 
with the Secretary of Agriculture and may contract and 
coordinate with the agency or department designated by 
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the Governor of each State to perform activities to ensure 
compliance with this section.’’. 
(c) TIMING.— 
(1) PROPOSED
RULE.—Not later than 18 
months after the date of enactment of this Act, the 
Secretary of Health and Human Services shall issue 
a proposed rule to carry out section 419A of the 
Federal Food, Drug, and Cosmetic Act, as added by 
subsection (a). 
(2) FINAL RULE.—Not later than 3 years after 
such date, the Secretary of Health and Human 
Services shall issue a final rule under such section. 
(d) NO EFFECT ON EXISTING HACCP AUTHORI-
TIES.—Nothing in this section or the amendments made 
by this section limits the authority of the Secretary under 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 
et seq.) or the Public Health Service Act (42 U.S.C. 201 
et seq.), as in effect on the day before the date of the 
enactment of this Act, to revise, issue, or enforce product- 
and category-specific regulations, such as the Seafood 
Hazard Analysis Critical Controls Points Program, the 
Juice Hazard Analysis Critical Control Program, and the 
Thermally Processed Low-Acid Foods Packaged in Her-
metically Sealed Containers standards. 
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(e) UPDATE EXISTING GUIDANCE.—Not later than 
one year after the date of the enactment of this Act, the 
Secretary of Health and Human Services shall update the 
guidance document entitled ‘‘Guidance For Industry: 
Guide To Minimize Microbial Food Safety Hazards For 
Fresh Fruits And Vegetables’’ (issued on October 26, 
1998) in accordance with this section and the amendments 
made by this section. 
SEC. 105. RISK-BASED INSPECTION SCHEDULE. 
(a) IN GENERAL.—Section 704 (21 U.S.C. 374) is 
amended by adding at the end the following: 
‘‘(h)(1) Each facility registered under section 415 
shall be inspected— 
‘‘(A)(i) by one or more officers duly designated 
under section 702 or other statutory authority by 
the Secretary; 
‘‘(ii) for domestic facilities, by a Federal, State, 
or local official recognized by the Secretary under 
paragraph (2); or 
‘‘(iii) for foreign facilities, by an agency or a 
representative of a country that is recognized by the 
Secretary under paragraph (2); and 
‘‘(B) at a frequency determined pursuant to a 
risk-based schedule. 
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‘‘(2) For purposes of paragraph (1)(A), the Sec-
retary— 
‘‘(A) may recognize Federal, State, and local of-
ficials and agencies and representatives of foreign 
countries as meeting standards established by the 
Secretary for conducting inspections under this Act; 
and 
‘‘(B) may limit such recognition to inspections 
of specific commodities or food types. 
‘‘(3) The risk-based schedule under paragraph (1)(B) 
shall be implemented beginning not later than 18 months 
after the date of the enactment of this subsection. 
‘‘(4) Such risk-based schedule shall provide for a fre-
quency of inspections commensurate with the risk pre-
sented by the facility and shall be based on the following 
categories and inspection frequencies: 
‘‘(A) CATEGORY 1.—A category 1 food facility 
is a high-risk facility that manufactures or processes 
food, including any facility that manufactures or 
processes raw products of animal origin (including 
fish and fisheries products) or other foods as des-
ignated by the Secretary. The Secretary shall ran-
domly inspect a category 1 food facility at least 
every 6 to 18 months. 
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‘‘(B) CATEGORY 2.—A category 2 food facility 
is a low-risk facility that manufactures or processes 
food or a facility that packs or labels food. The Sec-
retary shall randomly inspect a category 2 facility at 
least every 18 months to 3 years. 
‘‘(C) CATEGORY 3.—A category 3 food facility 
is a facility that holds food. The Secretary shall ran-
domly inspect a category 3 facility at least every 3 
to 4 years. 
‘‘(5) The Secretary— 
‘‘(A) may, by guidance, modify the types of 
food facilities within a category under paragraph 
(4); 
‘‘(B) may alter the inspection frequencies speci-
fied in paragraph (4) based on the need to respond 
to foodborne illness outbreaks and food recalls; and 
‘‘(C) may inspect a facility more frequently 
than the inspection frequency provided by paragraph 
(4). 
‘‘(6) In determining the appropriate frequency of in-
spection, the Secretary shall consider— 
‘‘(A) the type of food manufactured, processed, 
packed, or held at the facility; 
‘‘(B) the compliance history of the facility; 
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‘‘(C) whether the facility importing food is cer-
tified by a qualified certifying entity in accordance 
with section 801(p); and 
‘‘(D) such other factors as the Secretary deter-
mines by guidance to be relevant to assessing the 
risk presented by the facility.’’. 
(b) REPORTS
ON RISK-BASED INSPECTIONS
OF 
FOOD FACILITIES.— 
(1) ANNUAL REPORT.—Not later than Decem-
ber 31 of each year, the Secretary of Health and 
Human Services shall submit a report to the Com-
mittee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate describ-
ing— 
(A) the number of foreign and domestic fa-
cilities, by risk category, inspected under the 
risk-based inspection schedule established under 
section 704(h) of the Federal Food, Drug, and 
Cosmetic Act, as added by subsection (a), in 
the preceding 12 months; and 
(B) the costs of implementing the risk- 
based inspection schedule for the preceding 12 
months. 
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(2) THIRD-YEAR
REPORT.—Not later than 3 
years after the date of the enactment of this Act, the 
Secretary of Health and Human Services shall sub-
mit a report to the Committee on Energy and Com-
merce of the House of Representatives and the Com-
mittee on Health, Education, Labor, and Pensions 
of the Senate describing recommendations on the 
risk-based inspection schedule under section 704(h) 
of the Federal Food, Drug, and Cosmetic Act, as 
added by subsection (a), including recommendations 
for— 
(A) adjustments to the timing of the 
schedule and other ways to increase the effi-
ciency of inspections in order to enable the 
Food and Drug Administration to conduct more 
inspections; and 
(B) other methods to contribute to assur-
ing the safety of food. 
SEC. 106. ACCESS TO RECORDS. 
(a) RECORDS INSPECTION.—Subsection (a) of section 
414 (21 U.S.C. 350c) is amended to read as follows: 
‘‘(a) RECORDS INSPECTION.—Each person who pro-
duces, manufactures, processes, packs, transports, distrib-
utes, receives, or holds an article of food in the United 
States or for import into the United States shall, at the 
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request of an officer or employee duly designated by the 
Secretary, permit such officer or employee, upon presen-
tation of appropriate credentials, at reasonable times and 
within reasonable limits and in a reasonable manner, to 
have access to and copy all records relating to such article 
bearing on whether the food is adulterated, misbranded, 
or otherwise in violation of this Act, including all records 
collected or developed to comply with section 418 or 418A. 
The requirement under the preceding sentence applies to 
all records relating to the production, manufacture, proc-
essing, packing, transporting, distribution, receipt, hold-
ing, or importation of such article maintained by or on 
behalf of such person in any format (including paper and 
electronic formats) and at any location.’’. 
(b) REGULATIONS CONCERNING RECORDKEEPING.— 
(1) AMENDMENT.—Subsection (b) of section 
414 (21 U.S.C. 350c) is amended to read as follows: 
‘‘(b) 
REGULATIONS
CONCERNING
RECORD-
KEEPING.—The Secretary, in consultation and coordina-
tion, as appropriate, with other Federal departments and 
agencies with responsibilities for regulating food safety, 
may by regulation establish requirements regarding the es-
tablishment and maintenance, for not longer than 3 years, 
of records by persons who produce, manufacture, process, 
pack, transport, distribute, receive, or hold food in the 
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United States or for import into the United States. The 
Secretary shall take into account the size of a business 
in promulgating regulations under this section. The Sec-
retary may require such persons to maintain such records 
in a standardized electronic format.’’. 
(2) APPLICATION.—The Secretary of Health 
and Human Services shall promulgate revised regu-
lations to implement section 414(b) of the Federal 
Food, Drug, and Cosmetic Act , as amended by this 
subsection. Section 414(b) of the Federal Food, 
Drug, and Cosmetic Act and regulations thereunder, 
as in effect on the day before the date of the enact-
ment of this Act, shall apply to acts and omissions 
occurring before the effective date of such revised 
regulations. 
(c) CONFORMING AMENDMENTS.—Section 704(a)(1) 
(21 U.S.C. 374(a)(1)) is amended— 
(1) in the first sentence— 
(A) by inserting ‘‘farm,’’ before ‘‘factory’’ 
each place it appears; and 
(B) by inserting ‘‘produced,’’ before ‘‘man-
ufactured’’; 
(2) in the second sentence— 
(A) by striking ‘‘(excluding farms or res-
taurants)’’; 
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(B) by inserting ‘‘produces,’’ before ‘‘man-
ufactures’’; 
(C) by inserting ‘‘receives,’’ before ‘‘holds’’; 
(D) by striking ‘‘described in section 414’’ 
and inserting ‘‘described in or required under 
section 414’’; and 
(E) by striking ‘‘when the Secretary has a 
reasonable belief that an article of food is adul-
terated and presents a threat of serious adverse 
health consequences or death to humans or ani-
mals’’ and inserting ‘‘bearing on whether such 
food is adulterated, misbranded, or otherwise in 
violation of this Act, including all records col-
lected or developed to comply with section 418 
or 418A’’; and 
(3) in the fourth sentence— 
(A) by striking ‘‘the preceding sentence’’ 
and inserting ‘‘either of the preceding two sen-
tences’’; and 
(B) by inserting ‘‘recipes for food,’’ before 
‘‘financial data,’’. 
SEC. 107. TRACEABILITY OF FOOD. 
(a) PROHIBITED ACT.—Section 301(e) (21 U.S.C. 
331(e)) is amended by inserting ‘‘, the violation of any 
requirement of the food tracing system under section 
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414(c);’’ before ‘‘or the refusal to permit access to or 
verification or copying of any such required record’’. 
(b) IMPORTS.—Section 801(a) (21 U.S.C. 381(a)) is 
amended by inserting ‘‘or (4) the requirements of section 
414 have not been complied with regarding such article,’’ 
before ‘‘then such article shall be refused admission’’. 
(c) PRODUCT TRACING FOR FOOD.—Section 414 (21 
U.S.C. 350c), as amended by section 106, is amended— 
(1) by redesignating subsections (c) and (d) as 
subsections (d) and (e), respectively; and 
(2) by inserting after subsection (b) the fol-
lowing: 
‘‘(c) TRACING SYSTEM FOR FOOD.— 
‘‘(1) IN GENERAL.—The Secretary shall by reg-
ulation establish a tracing system for food that is lo-
cated in the United States or is for import into the 
United States. Such regulations shall require each 
person who produces, manufactures, processes, 
packs, transports, or holds such food— 
‘‘(A) to maintain the full pedigree of the 
origin and previous distribution history of the 
food; 
‘‘(B) to link that history with the subse-
quent distribution history of the food; 
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‘‘(C) to establish and maintain a system 
for tracing the food that is interoperable with 
the systems established and maintained by 
other such persons; and 
‘‘(D) to use a unique identifier for each fa-
cility owned or operated by such person for 
such purpose, as specified under section 911. 
‘‘(2) INFORMATION GATHERING.— 
‘‘(A) TRACING
TECHNOLOGIES.—Before 
issuing a proposed regulation under this sub-
section, the Secretary shall— 
‘‘(i) identify technologies for tracing 
the distribution history of a food that are, 
or may be, used by members of different 
sectors of the food industry; and 
‘‘(ii) to the extent practicable, as-
sess— 
‘‘(I) the costs and benefits associ-
ated with the adoption and use of 
such technologies; 
‘‘(II) the feasibility of such tech-
nologies for different sectors of the 
food industry; and 
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‘‘(III) whether such technologies 
are compatible with the requirements 
of this subsection. 
‘‘(B) PUBLIC MEETINGS.—Before issuing a 
proposed regulation under this subsection, the 
Secretary shall conduct not less than 2 public 
meetings in diverse geographical areas of the 
United States to provide persons in different re-
gions an opportunity to provide input and infor-
mation to the Secretary. 
‘‘(C) PILOT
PROJECTS.—The Secretary 
shall conduct 1 or more pilot projects in coordi-
nation with 1 or more sectors of the food indus-
try to explore and evaluate tracing systems for 
food. 
‘‘(3) ADDITIONAL AUTHORITY.—In establishing 
a tracing system for food, the Secretary shall re-
quire— 
‘‘(A) the establishment and maintenance of 
such additional information, including lot num-
bers, as the Secretary deems appropriate; 
‘‘(B) a standardized format for pedigree 
information; and 
‘‘(C) the use of a common nomenclature 
for food. 
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‘‘(4) EXEMPTIONS.— 
‘‘(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 restaurant. 
‘‘(B) OTHER FOODS.—The Secretary may 
by notice in the Federal Register exempt a food 
from the requirements of this subsection if the 
Secretary determines that a tracing system for 
such food is not necessary to protect the public 
health. 
‘‘(C) PREVIOUS
SOURCES
AND
SUBSE-
QUENT RECIPIENTS.—For a food covered by an 
exemption under subparagraph (B), the Sec-
retary shall require each person who produces, 
manufactures, processes, packs, transports, 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.’’. 
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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 facility (as defined in section 
415(b)) 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 
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‘‘(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) USE OF FEES.—The Secretary shall make all 
fees collected pursuant to this section available solely to 
pay for the costs referred to in subsection (b).’’. 
(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(p) (requiring a certification to accompany 
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. 
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(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 an article of food being imported or of-
fered for import into the United States is not in 
compliance with the requirement of subsection (p) 
(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: 
‘‘(p) CERTIFICATIONS CONCERNING IMPORTED ARTI-
CLES.— 
‘‘(1) IN GENERAL.— 
‘‘(A) REQUIREMENT.—The Secretary shall 
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 specified 
requirements of this Act if— 
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‘‘(i) for food imported from a par-
ticular country or region, based on the 
adequacy of government controls in such 
country or region or other information rel-
evant to such food, certification would as-
sist the Secretary in determining whether 
to refuse to admit such article under sub-
section (a); 
‘‘(ii) for a type of food that could pose 
a significant risk to health, certification 
would assist the Secretary in determining 
whether such article poses such risk; or 
‘‘(iii) for an article imported from a 
particular country, there is an agreement 
between the Secretary and the government 
of such country providing for such certifi-
cation. 
‘‘(B) CONTENTS
OF
CERTIFICATION.— 
Such certification shall include such informa-
tion regarding compliance as the Secretary may 
specify, and may be provided in the form of 
shipment-specific certificates, a listing of cer-
tified facilities or other entities, or in such other 
form as the Secretary may specify. 
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‘‘(C) 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 included in a listing under subparagraph 
(B). 
‘‘(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 to be qualified to provide a cer-
tification 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. 
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‘‘(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; 
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‘‘(vi) the qualified certifying entity 
shall maintain records pertaining to the fi-
nancial interests of the personnel involved 
in audits; 
‘‘(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; 
‘‘(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; 
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‘‘(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 also ensure that any subcontractors 
that might be used (such as laboratories 
and sampling services) provide similar as-
surances. 
‘‘(C) ANYTHING OF VALUE.—In this para-
graph, the term ‘anything of value’ includes 
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gifts, gratuities, reimbursement of expenses, en-
tertainment, loans, or any other form of com-
pensation in cash or in kind. 
‘‘(4) RENEWAL
AND
REFUSAL
OF
CERTIFI-
CATIONS.—The Secretary shall— 
‘‘(A) require that, to the extent applicable, 
any certification provided by a qualified certi-
fying entity be renewed by such entity at such 
times as the Secretary determines appropriate; 
and 
‘‘(B) refuse to accept any certification if 
the Secretary determines that such certification 
is no longer valid or reliable. 
‘‘(5) ELECTRONIC SUBMISSION.—The Secretary 
shall provide for the electronic submission of certifi-
cations under this subsection. 
‘‘(6) 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 
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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: 
‘‘(oo) 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.—Whenever analytical testing of 
an article of food is conducted as part of testimony for 
the purposes of section 801(a), or for other purposes as 
the Secretary deems appropriate, such testing shall be 
conducted by a laboratory that— 
‘‘(1) is independent of the person on whose be-
half such testing is conducted; 
‘‘(2) is accredited, for the analytical method 
used, by a laboratory accreditation body that has 
been recognized by the Secretary; and 
‘‘(3) samples such article, itself or through an 
independent third party, with adequate controls for 
ensuring the integrity of the samples analyzed. 
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‘‘(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) ON-SITE 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 on-site 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 on- 
site audit of the laboratory, which shall include ac-
cess 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 
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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; 
‘‘(2) all information the Secretary deems appro-
priate to— 
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‘‘(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)(2) (relating 
to 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.’’. 
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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: 
‘‘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(r) 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, 
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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 adverse 
health consequences or death to humans or animals, the 
Secretary shall have the authority to issue an order requir-
ing any person who distributes such article— 
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‘‘(1) to immediately cease distribution of such 
article; and 
‘‘(2) to immediately notify any person to whom 
the article was distributed of the order. 
In providing for notice under paragraph (2), the Secretary 
may, as appropriate, allow such notice to be provided with 
the assistance of health care professionals, State or local 
health officials, or other persons designated by the Sec-
retary. 
‘‘(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, if granted, shall be held within 10 
business 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 wheth-
er the order should be amended to require a recall of such 
article. If, after providing an opportunity for such a hear-
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ing, the Secretary determines that inadequate grounds 
exist to support the actions required by the order, the Sec-
retary 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. 
‘‘(f) EMERGENCY RECALL ORDER.— 
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‘‘(1) IN GENERAL.—If the Secretary has a rea-
sonable belief that an article of food subject to an 
order under subsection (c) presents a threat of seri-
ous adverse health consequences or death to humans 
or animals, the Secretary may issue an order requir-
ing 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, if 
granted, shall be held within 10 business 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 in-
formal hearing, the Secretary shall determine wheth-
er the order should be amended pursuant to sub-
section (e)(1). If, after providing an opportunity for 
such a hearing, the Secretary determines that inad-
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equate grounds exist to support the actions required 
by the order, the Secretary shall vacate the order. 
‘‘(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’’. 
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(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 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; 
‘‘(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; 
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‘‘(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(r) with respect to im-
portation of such food.’’; 
(2) in subsection (d)(1)— 
(A) in the matter preceding subparagraph 
(A)— 
(i) by inserting ‘‘information reason-
ably available to’’ after ‘‘after’’; and 
(ii) by striking ‘‘determines’’ and in-
serting ‘‘indicates’’; 
(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, 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 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 
(3) 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 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-
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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 
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— 
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‘‘(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-
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-
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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. 
‘‘(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 
movement of food through the importation process under 
this Act if the importer of such food— 
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‘‘(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; 
‘‘(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 safety and security guidelines applica-
ble to the importation of food. 
‘‘(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. 
‘‘(D) Vendor and supplier information. 
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‘‘(E) Such other factors as the Secretary 
determines necessary.’’. 
SEC. 114. INFANT FORMULA. 
(a) MISBRANDING.—Section 403 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 343) as amend-
ed 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 es-
tablished under this paragraph may include require-
ments for one or more clinical studies to dem-
onstrate that the new infant formula supports nor-
mal physical growth of infants.’’; 
(2) in subsection (b)(4), amend subparagraph 
(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-
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retary for review and duplication upon request of the Sec-
retary.’’; 
(3) in subsection (c)(1)— 
(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 
requirements in subsection (d)(1) have been satis-
fied.’’; 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 
satisfies the requirements of subsection (b)(1), and, 
as demonstrated by the testing required under sub-
section (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 demonstrates that the processing of the 
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infant formula complies with the requirements of 
subsection (b)(2).’’. 
Subtitle B—Intervention 
SEC. 121. PUBLIC HEALTH ASSESSMENT SYSTEM. 
(a) SURVEILLANCE
SYSTEM.—The Secretary of 
Health and Human Services (in this subtitle referred to 
as the ‘‘Secretary’’) shall build upon the existing surveil-
lance system for food, based on a representative propor-
tion of the population of the United States, to assess the 
frequency and sources of human illness in the United 
States associated with the consumption of food. 
(b) SAMPLING AND ASSESSMENT.— 
(1) IN GENERAL.—The Secretary shall utilize, 
as appropriate, samples of food collected and ana-
lyzed by, or on behalf of, the Secretary in carrying 
out the Secretary’s duties under this Act and the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
301 et seq.) and may collect and analyze additional 
samples of food to assess the nature, frequency of 
occurrence, and amounts of contaminants in food. 
(2) REQUIREMENTS.—Assessment by the Sec-
retary under this section may employ, in the Sec-
retary’s discretion, statistically valid monitoring, in-
cluding market-basket studies, on the nature, fre-
quency of occurrence, and amounts of contaminants 
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in food available to consumers, and at the request of 
the Secretary such other information as the Sec-
retary determines may be useful. 
(c) PUBLIC AVAILABILITY OF ASSESSMENT.—To the 
extent it does not impede the ability of the United States 
to protect against terrorist threats and other intentional 
attacks against the food supply, the Secretary may make 
publicly available, by posting on the Web site of the De-
partment of Health and Human Services, the results of 
any assessment conducted under this section. To the ex-
tent feasible with the data and information available, the 
assessment may rank food categories based on their haz-
ard to human health and may address— 
(1) the safety of commercial harvesting and 
processing, as compared with the health hazards as-
sociated with food products that are harvested for 
recreational or subsistence purposes and prepared 
noncommercially; 
(2) the safety of food products that are domes-
tically harvested and processed, as compared with 
the health hazards associated with food products 
that are harvested or processed outside the United 
States; and 
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(3) contamination originating from handling 
practices that occur prior to or after sale of food 
products to consumers. 
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 reduce their risk of foodborne illness and injury 
and make healthy dietary 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 
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(3) incorporate State and local advisories into 
the national public education program required 
under subsection (a). 
SEC. 123. RESEARCH. 
(a) IN GENERAL.—The Secretary shall conduct re-
search to assist in the implementation of this Act, includ-
ing studies to— 
(1) improve sanitation and food safety practices 
in the 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; 
(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; 
(8) address common and emerging zoonotic dis-
eases; 
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(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 develop 
new methods to reduce the transfer of antibiotic re-
sistance to humans; and 
(11) conduct other research that supports the 
purposes of this Act. 
(b) CONTRACT AUTHORITY.—The Secretary is au-
thorized to enter into contracts and agreements with any 
State, university, government agency, or other person to 
carry out this section. 
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’’. 
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