SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Food Safety Enhance-
ment Act of 2009’’. 
SEC. 2. TABLE OF CONTENTS. 
The table of contents of this Act is as follows: 
Sec. 1. Short title. 
Sec. 2. Table of contents. 
Sec. 3. References. 
Sec. 4. Rules of construction. 
Sec. 5. USDA exemptions. 
Sec. 6. Alcohol-related facilities. 
TITLE I—FOOD SAFETY 
Subtitle A—Prevention 
Sec. 101. Changes in registration of food facilities. 
Sec. 102. Hazard analysis, risk-based preventive controls, food safety plan, fin-
ished product test results from category 1 facilities. 
Sec. 103. Performance standards. 
Sec. 104. Safety standards for produce and certain other raw agricultural com-
modities. 
Sec. 105. Risk-based inspection schedule. 
Sec. 106. Access to records. 
Sec. 107. Traceability of food. 
Sec. 108. Reinspection and food recall fees applicable to facilities. 
Sec. 109. Certification and accreditation. 
Sec. 110. Testing by accredited laboratories. 
Sec. 111. Notification, nondistribution, and recall of adulterated or misbranded 
food. 
Sec. 112. Reportable food registry; exchange of information. 
Sec. 113. Safe and secure food importation program. 
Sec. 114. Infant formula. 
Subtitle B—Intervention 
Sec. 121. Surveillance. 
Sec. 122. Public education and advisory system. 
Sec. 123. Research. 
Subtitle C—Response 
Sec. 131. Procedures for seizure. 
Sec. 132. Administrative detention. 
Sec. 133. Authority to prohibit or restrict the movement of food. 
Sec. 134. Criminal penalties. 
Sec. 135. Civil penalties for violations relating to food. 
Sec. 136. Improper import entry filings. 
TITLE II—MISCELLANEOUS 
Sec. 201. Food substances generally recognized as safe.
Sec. 202. Country of origin labeling. 
Sec. 203. Exportation certificate program. 
Sec. 204. Registration for commercial importers of food; fee. 
Sec. 205. Registration for customs brokers. 
Sec. 206. Unique identification number for food facilities, importers, and cus-
tom brokers. 
Sec. 207. Prohibition against delaying, limiting, or refusing inspection. 
Sec. 208. Dedicated foreign inspectorate. 
Sec. 209. Plan and review of continued operation of field laboratories. 
Sec. 210. False or misleading reporting to FDA. 
Sec. 211. Subpoena authority. 
Sec. 212. Whistleblower protections. 
Sec. 213. Extraterritorial jurisdiction. 
Sec. 214. Support for training institutes. 
Sec. 215. Bisphenol A in food and beverage containers. 
Sec. 216. Lead content labeling requirement for ceramic tableware and 
cookware. 
SEC. 3. REFERENCES. 
Except as otherwise specified, whenever in this Act 
an amendment is expressed in terms of an amendment to 
a section or other provision, the reference shall be consid-
ered to be made to a section or other provision of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.). 
SEC. 4. RULES OF CONSTRUCTION. 
(a) Nothing in this Act or the amendments made by 
this Act shall be construed to prohibit or limit— 
(1) any cause of action under State law; or 
(2) the introduction of evidence of compliance 
or noncompliance with the requirements of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 
et seq.). 
(b) Nothing in this Act or any amendment made by 
this Act shall be construed to—
(1) alter the jurisdiction between the Secretary 
of Agriculture and the Secretary of Health and 
Human Services, under applicable statutes and regu-
lations; 
(2) limit the authority of the Secretary of 
Health and Human Services to issue regulations re-
lated to the safety of food under— 
(A) the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 301 et seq.) as in effect on the 
day before the date of the enactment of this 
Act; or 
(B) the Public Health Service Act (42 
U.S.C. 301 et seq.) as in effect on the day be-
fore the date of the enactment of this Act; or 
(3) impede, minimize, or affect the authority of 
the Secretary of Agriculture to prevent, control, or 
mitigate a plant or animal health emergency, or a 
food emergency involving products regulated under 
the Federal Meat Inspection Act (21 U.S.C. 601 et 
seq.), the Poultry Products Inspection Act (21 
U.S.C. 451 et seq.), or the Egg Products Inspection 
Act (21 U.S.C. 1031 et seq.). 
SEC. 5. USDA EXEMPTIONS. 
(a) USDA-REGULATED PRODUCTS.—Food is exempt 
from the requirements of this Act to the extent that such
food is regulated by the Secretary of Agriculture under 
the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), 
the Poultry Products Inspection Act (21 U.S.C. 451 et 
seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 
et seq.). 
(b) LIVESTOCK AND POULTRY.—Livestock and poul-
try that are intended to be presented for slaughter pursu-
ant to the regulations by the Secretary of Agriculture 
under the Federal Meat Inspection Act or the Poultry 
Products Inspection Act are exempt from the require-
ments of this Act. A cow, sheep, or goat that is used for 
the production of milk is exempt from the requirements 
of this Act. 
(c) USDA-REGULATED FACILITIES.—A facility is ex-
empt from the requirements of this Act to the extent such 
facility is regulated as an official establishment by the Sec-
retary of Agriculture under the Federal Meat Inspection 
Act, the Poultry Products Inspection Act, or the Egg 
Products Inspection Act or under a program recognized 
by the Secretary of Agriculture as at least equal to Fed-
eral regulation under the Federal Meat Inspection Act, the 
Poultry Products Inspection Act, or the Egg Products In-
spection Act. 
(d) FARMS.—A farm is exempt from the require-
ments of this Act to the extent such farm raises animals
from which food is derived that is regulated under the 
Federal Meat Inspection Act, the Poultry Products In-
spection Act, or the Egg Products Inspection Act. 
SEC. 6. ALCOHOL-RELATED FACILITIES. 
(a) IN GENERAL.—With the exception of the amend-
ments made by section 101(a) and (b) and section 113 
of this Act, nothing in this Act, or the amendments made 
by this Act, shall be construed to apply to a facility that— 
(1) under the Federal Alcohol Administration 
Act (27 U.S.C. 201 et seq.) or chapter 51 of subtitle 
E of the Internal Revenue Code of 1986 (26 U.S.C. 
5291 et seq.) is required to obtain a permit or to 
register with the Secretary of the Treasury as a con-
dition of doing business in the United States; and 
(2) under section 415 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 350d), as 
amended by this Act, is required to register as a fa-
cility because such facility is engaged in manufac-
turing, processing, packing, or holding 1 or more al-
coholic beverages. 
(b) LIMITED RECEIPT AND DISTRIBUTION OF NON- 
ALCOHOL FOOD.—Subsection (a) shall not apply to a fa-
cility engaged in the distributing of any non-alcohol food, 
except that subsection (a) shall apply to a facility de-
scribed in paragraphs (1) and (2) of subsection (a) that
(1) DEFINITION OF FACILITY.—Paragraph (1) 
of section 415(b) (21 U.S.C. 350d(b)) is amended to 
read as follows: 
‘‘(1)(A) The term ‘facility’ means any factory, 
warehouse, or establishment (including a factory, 
warehouse, or establishment of an importer) that 
manufactures, processes, packs, or holds food. 
‘‘(B) Such term does not include farms; private 
residences of individuals; restaurants; other retail 
food establishments; nonprofit food establishments 
in which food is prepared for or served directly to 
the consumer; or fishing vessels (except such vessels 
engaged in processing as defined in section 123.3(k) 
of title 21, Code of Federal Regulations, or any suc-
cessor regulations). 
‘‘(C)(i) The term ‘retail food establishment’ 
means an establishment that, as its primary func-
tion, sells food products (including those food prod-
ucts that it manufactures, processes, packs, or 
holds) directly to consumers (including by Internet 
or mail order). 
‘‘(ii) Such term includes— 
‘‘(I) grocery stores; 
‘‘(II) convenience stores; 
‘‘(III) vending machine locations; and
‘‘(IV) stores that sell bagged feed, pet 
food, and feed ingredients or additives 
over-the-counter directly to consumers and 
final purchasers for their own personal ani-
mals. 
‘‘(iii) A retail food establishment’s primary 
function is to sell food directly to consumers if 
the annual monetary value of sales of food 
products directly to consumers exceeds the an-
nual monetary value of sales of food products to 
all other buyers. 
‘‘(D)(i) The term ‘farm’ means an operation in 
one general physical location devoted to the growing 
and harvesting of crops, the raising of animals (in-
cluding seafood), or both. 
‘‘(ii) Such term includes— 
‘‘(I) such an operation that packs or holds 
food, provided that all food used in such activi-
ties is grown, raised, or consumed on such farm 
or another farm under the same ownership; 
‘‘(II) such an operation that manufactures 
or processes food, provided that all food used in 
such activities is consumed on such farm or an-
other farm under the same ownership;
‘‘(III) such an operation that sells food di-
rectly to consumers if the annual monetary 
value of sales of the food products from the 
farm or by an agent of the farm to consumers 
exceeds the annual monetary value of sales of 
the food products to all other buyers; 
‘‘(IV) such an operation that manufactures 
grains or other feed stuffs that are grown and 
harvested on such farm or another farm under 
the same ownership and are distributed directly 
to 1 or more farms for consumption as food by 
humans or animals on such farm; and 
‘‘(V) a fishery, including a wild fishery, an 
aquaculture operation or bed, a fresh water 
fishery, and a saltwater fishery. 
‘‘(iii) Such term does not include such an oper-
ation that receives manufactured feed from another 
farm as described in clause (ii)(IV) if the receiving 
farm releases the feed to another farm or facility 
under different ownership. 
‘‘(iv) The term ‘harvesting’ includes washing, 
trimming of outer leaves of, and cooling produce. 
‘‘(E) The term ‘consumer’ does not include a 
business.’’.
(2) REGISTRATION.—Section 415(a) (21 U.S.C. 
350d(a)) is amended— 
(A) in the first sentence of paragraph 
(1)— 
(i) by striking ‘‘require that’’ and in-
serting ‘‘require that, on or before Decem-
ber 31 of each year,’’; and 
(ii) by striking ‘‘food for consumption 
in the United States’’ and inserting ‘‘food 
for consumption in the United States or 
for export from the United States’’; 
(B) in subparagraphs (A) and (B) of para-
graph (1), by inserting ‘‘and pay the registra-
tion fee required under section 743’’ after ‘‘sub-
mit a registration to the Secretary’’ each place 
it appears; 
(C) in the first sentence of paragraph (2), 
by inserting ‘‘in electronic format’’ after ‘‘sub-
mit’’; and 
(D) in paragraph (4), by inserting after 
the first sentence the following: ‘‘The Secretary 
shall remove from such list the name of any fa-
cility that fails to reregister in accordance with 
this section, that fails to pay the registration 
fee required under section 743, or whose reg-
istration is canceled by the registrant, canceled 
by the Secretary in accordance with this sec-
tion, or suspended by the Secretary in accord-
ance with this section.’’. 
(3) CONTENTS OF REGISTRATION.—Paragraph 
(2) of section 415(a) (21 U.S.C. 350d(a)), as 
amended by paragraph (1), is amended by striking 
‘‘containing information’’ and all that follows and in-
serting the following: ‘‘containing information that 
identifies the following: 
‘‘(A) The name, address, and emergency 
contact information of the facility being reg-
istered. 
‘‘(B) The primary purpose and business 
activity of the facility, including the dates of op-
eration if the facility is seasonal. 
‘‘(C) The general food category (as defined 
by the Secretary by guidance) of each food 
manufactured, processed, packed, or held at the 
facility. 
‘‘(D) All trade names under which the fa-
cility conducts business related to food. 
‘‘(E) The name, address, and 24-hour 
emergency contact information of the United 
States distribution agent for the facility, which
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 1011. 
‘‘(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.’’. 
(4) 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
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.—
‘‘(A) The number of facilities registered 
under this section. 
‘‘(B) The number of such facilities that are 
domestic. 
‘‘(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. 
‘‘(8) LIMITATION
ON
DELEGATION.—The au-
thority conferred by this subsection to issue an order 
to suspend a registration or cancel a registration 
shall not be delegated to any officer or employee 
other than the Commissioner of Food and Drugs, 
the Principal Deputy Commissioner, the Associate 
Commissioner for Regulatory Affairs, or the Direc-
tor for the Center for Food Safety and Applied Nu-
trition, of the Food and Drug Administration.’’. 
(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— 
‘‘(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, $500; 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). 
‘‘(3) 
MAXIMUM
AMOUNT.—Notwithstanding 
paragraph (1), a person who owns or operates mul-
tiple facilities for which a fee must be paid under 
this section for a fiscal year shall be liable for not 
more than $175,000 in aggregate fees under this 
section for such fiscal year. 
‘‘(c) INFLATION ADJUSTMENT.—For fiscal year 2011 
and each subsequent fiscal year, the fee amount under 
subsection (b)(1) shall be adjusted by the Secretary by no-
tice, 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-
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 
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 
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. 
‘‘(4) PUBLIC MEETINGS.—For each fiscal year, 
the Secretary shall hold a public meeting on how 
fees collected under this section will be used to de-
fray the costs of food safety activities in order to so-
licit the views of the regulated industry, consumers, 
and other interested stakeholders. 
‘‘(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.
‘‘(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, employees, 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-
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).’’.
(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.
SEC. 102. HAZARD ANALYSIS, RISK-BASED PREVENTIVE 
CONTROLS, FOOD SAFETY PLAN, FINISHED 
PRODUCT TEST RESULTS FROM CATEGORY 1 
FACILITIES. 
(a) HAZARD ANALYSIS, RISK-BASED PREVENTIVE 
CONTROLS, FOOD SAFETY PLAN.— 
(1) 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.’’. 
(2) 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 and implement effective preventive 
controls; 
‘‘(3) monitor preventive controls; 
‘‘(4) institute corrective actions when—
‘‘(A) monitoring shows that preventive con-
trols have not been properly implemented; or 
‘‘(B) monitoring and verification show that 
such controls were ineffective; 
‘‘(5) conduct verification activities; 
‘‘(6) maintain records of monitoring, corrective 
action, and verification; and 
‘‘(7) reanalyze for hazards. 
‘‘(b) IDENTIFICATION OF HAZARDS.— 
‘‘(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 or that 
may be unintentionally introduced.
‘‘(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 
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 and implement effec-
tive preventive controls to prevent, eliminate, or re-
duce to acceptable levels the occurrence of any haz-
ards identified in the hazard analysis under sub-
section (b)(3). 
‘‘(2) IDENTIFIED BY THE SECRETARY.— 
‘‘(A) 
ESTABLISHMENT.—The 
Secretary 
may establish by regulation or guidance preven-
tive controls for specific product types to pre-
vent unintentional contamination throughout 
the supply chain. The owner, operator, or agent 
of a facility shall implement any preventive con-
trols identified by the Secretary under this 
paragraph.
under this Act in which the facility involved is lo-
cated, or is an official senior to such director. 
‘‘(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 
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 to the type of facility or food: 
‘‘(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. 
‘‘(G) Other procedures, practices, and 
processes established by the Secretary under 
subsection (c)(2). 
‘‘(3) HAZARD THAT IS REASONABLY LIKELY TO 
OCCUR.—A food safety hazard that is reasonably 
likely to occur is one for which a prudent person 
who, as applicable, manufactures, processes, packs, 
transports, or holds food, would establish controls 
because experience, illness data, scientific reports, or 
other information provides a basis to conclude that 
there is a reasonable possibility that the hazard will 
occur in the type of food being manufactured, proc-
essed, packed, transported, or held in the absence of 
those controls. 
‘‘SEC. 418A. FOOD SAFETY PLAN. 
‘‘(a) IN GENERAL.—Before a facility (as defined in 
section 418(i)) introduces or delivers for introduction into 
interstate commerce any shipment of food, the owner, op-
erator, or agent of the facility shall develop and implement 
a written food safety plan (in this section referred to as 
a ‘food safety plan’). 
‘‘(b) CONTENTS.—The food safety plan shall include 
each of the following elements: 
‘‘(1) The hazard analysis and any reanalysis 
conducted under section 418. 
‘‘(2) A description of the preventive controls 
being implemented under subsection 418(c), includ-
ing those to address hazards identified by the Sec-
retary under subsection 418(b)(2). 
‘‘(3) A description of the procedures for moni-
toring preventive controls. 
‘‘(4) A description of the procedures for taking 
corrective actions. 
‘‘(5) A description of verification activities for 
the preventive controls, including validation that the 
system of controls, if implemented, will prevent, 
eliminate, or reduce to an acceptable level the identi-
fied hazards, review of monitoring and corrective ac-
tion records, and procedures for determining wheth-
er the system of controls as implemented is effec-
tively preventing, eliminating, or reducing to an ac-
ceptable level the occurrence of identified hazards, 
including the use of environmental and product test-
ing programs. 
‘‘(6) A description of the facility’s record-
keeping procedures. 
‘‘(7) A description of the facility’s procedures 
for the recall of articles of food, whether voluntarily 
or when required under section 422. 
‘‘(8) A description of the facility’s procedures 
for tracing the distribution history of articles of 
food, whether voluntarily or when required under 
section 414. 
‘‘(9) A description of the facility’s procedures to 
ensure a safe and secure supply chain for the ingre-
dients or components used in making the food man-
ufactured, processed, packed, transported, or held by 
such facility. 
‘‘(10) A description of the facility’s procedures 
to implement the science-based performance stand-
ards issued under section 419.’’. 
(3) GUIDANCE OR REGULATIONS.—
(A) 
IN
GENERAL.—The 
Secretary 
of 
Health and Human Services (referred to in this 
subsection as the ‘‘Secretary’’) shall issue guid-
ance or promulgate regulations to establish 
science-based standards for conducting a haz-
ard analysis, documenting hazards, identifying 
and implementing preventive controls, and doc-
umenting the implementation of the preventive 
controls, including verification and corrective 
actions under sections 418 and 418A of the 
Federal Food, Drug, and Cosmetic Act (as 
added by paragraph (2)). 
(B) 
INTERNATIONAL
STANDARDS.—In 
issuing guidance or regulations under subpara-
graph (A), the Secretary shall review inter-
national hazard analysis and preventive control 
standards that are in existence on the date of 
the enactment of this Act and relevant to such 
guidelines or regulations to ensure that the pro-
grams under sections 418 and 418A of the Fed-
eral Food, Drug, and Cosmetic Act (as added 
by paragraph (2) are consistent, to the extent 
the Secretary determines practicable and appro-
priate, with such standards.
(C) AUTHORITY WITH RESPECT TO CER-
TAIN FACILITIES.—The Secretary may, by regu-
lation, exempt or modify the requirements for 
compliance under this section and the amend-
ments made by this section with respect to fa-
cilities that are solely engaged in— 
(i) the production of food for animals 
other than man or the storage of packaged 
foods that are not exposed to the environ-
ment; or 
(ii) the storage of raw agricultural 
commodities for further distribution or 
processing. 
(D) 
SMALL
BUSINESSES.—The 
Sec-
retary— 
(i) shall consider the impact of any 
guidance or regulations under this section 
on small businesses; and 
(ii) shall issue guidance to assist small 
businesses in complying with the require-
ments of this section and the amendments 
made by this section. 
(4) NO EFFECT ON EXISTING HACCP AUTHORI-
TIES.—Nothing in this section or the amendments 
made by this section limits the authority of the Sec-
retary 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 
Hermetically Sealed Containers standards. 
(5) CONSIDERATION.—When implementing sec-
tions 418 and 418A of the Federal Food, Drug, and 
Cosmetic Act, as added by paragraph (2), the Sec-
retary may take into account differences between 
food intended for human consumption and food in-
tended for consumption by animals other than man. 
(6) EFFECTIVE DATE.— 
(A) GENERAL
RULE.—The amendments 
made by subsection (a) and this subsection 
shall take effect 18 months after the date of the 
enactment of this Act. 
(B) EXCEPTIONS.—Notwithstanding sub-
paragraph (A)— 
(i) the amendments made by sub-
section (a) and this subsection shall apply
ject to good manufacturing practices regulations docu-
menting the presence of contaminants in food in the pos-
session or control of such facility posing a risk of severe 
adverse health consequences or death. 
‘‘(b) CONSIDERATIONS.—The Secretary shall require 
submissions under subsection (a)— 
‘‘(1) as the Secretary determines feasible and 
appropriate; and 
‘‘(2) taking into consideration available data 
and information on the potential risks posed by the 
facility. 
‘‘(c) BEGINNING DATE.—The date specified in this 
subsection is the sooner of— 
‘‘(1) the date of completion of the pilot projects 
and feasibility study under subsections (d) and (e); 
and 
‘‘(2) the date that is 2 years after the date of 
the enactment of this section. 
‘‘(d) PILOT PROJECTS.—The Secretary shall conduct 
2 or more pilot projects to evaluate the feasibility of col-
lecting positive finished product testing results from cat-
egory 1 facilities, including the value and feasibility of re-
porting corrective actions taken when positive finished 
product test results are reported to the Secretary.
‘‘(e) FEASIBILITY STUDY.—The Secretary shall as-
sess the feasibility and benefits of the reporting by facili-
ties subject to good manufacturing practices regulations 
of appropriate finished product testing results from cat-
egory 1 facilities to the Secretary, including the extent to 
which the collection of such finished product testing re-
sults will help the Secretary assess the risk presented by 
a facility or product category. 
‘‘(f) LIMITATIONS.—Nothing in this section shall be 
construed— 
‘‘(1) to require the Secretary to mandate test-
ing or submission of test results that the Secretary 
determines would not provide useful information in 
assessing the potential risk presented by a facility or 
product category; or 
‘‘(2) to limit the Secretary’s authority under 
any other provisions of law to require any person to 
provide access, or to submit information or test re-
sults, to the Secretary, including the ability of the 
Secretary to require field or other testing and to ob-
tain test results in the course of an investigation of 
a potential food-borne illness or contamination inci-
dent.
‘‘(g) DEFINITION.—In this section, the term ‘cat-
egory 1 facility’ means a category 1 facility within the 
meaning of section 704(h).’’. 
(c) FOOD DEFENSE.— 
(1) ADULTERATION.—Section 402(j), as added 
by subsection (a), is amended by striking ‘‘and 
418A’’ and inserting ‘‘, 418A, or 418C’’. 
(2) REQUIREMENTS.—Chapter IV (21 U.S.C. 
341 et seq.), as amended, is further amended by 
adding at the end the following: 
‘‘SEC. 418C. FOOD DEFENSE. 
‘‘(a) IN GENERAL.—Before a facility (as defined in 
section 418(i)) introduces or delivers for introduction into 
interstate commerce any shipment of food, the owner, op-
erator, or agent of the facility shall develop and implement 
a written food defense plan (in this section referred to as 
a ‘food defense plan’). 
‘‘(b) CONTENTS.—The food defense plan shall in-
clude each of the following elements: 
‘‘(1) A food defense assessment to identify con-
ditions and practices that may permit a hazard that 
may be intentionally introduced, including by an act 
of terrorism. This assessment shall evaluate proc-
essing security, cybersecurity, material security (in-
cluding ingredients, finished product, and pack-
aging), personnel security, storage security, shipping 
and receiving security, and utility security. 
‘‘(2) A description of the preventive measures 
being implemented as a result of such assessment to 
minimize the risk of intentional contamination. 
‘‘(3) A description of the procedures to check 
for and identify any circumstances in which the pre-
ventive measures are not fully implemented or were 
ineffective. 
‘‘(4) A description of the procedures for taking 
corrective actions to ensure that when preventive 
measures have not been properly implemented or 
have been ineffective, appropriate action is taken— 
‘‘(A) to reduce the likelihood of recurrence 
of the failure; and 
‘‘(B) to assess the consequences of the fail-
ure. 
‘‘(5) A description of evaluation activities for 
the preventive measures, including a review of 
records provided for under paragraph (6) and proce-
dures to periodically test the effectiveness of the 
plan. 
‘‘(6) A description of the facility’s record-keep-
ing procedures, including records documenting im-
plementation of the procedures under paragraphs 
(3), (4), and (5). 
‘‘(c) HAZARD.—For purposes of this section, the 
term ‘hazard that may be intentionally introduced, includ-
ing by an act of terrorism’ means a hazard for which a 
prudent person who, as applicable, manufactures, proc-
esses, packs, transports, or holds food, would establish 
preventive measures because the hazard has been identi-
fied by a food defense assessment by application of— 
‘‘(1) a targeting assessment tool recommended 
by the Secretary by guidance; or 
‘‘(2) a comparable targeting assessment tool. 
‘‘(d) FOOD DEFENSE HAZARDS IDENTIFIED BY THE 
SECRETARY.— 
‘‘(1) ESTABLISHMENT.—The Secretary may es-
tablish by regulation or guidance preventive meas-
ures for specific product types to prevent intentional 
contamination throughout the supply chain. The 
owner, operator, or agent of a facility shall imple-
ment any preventive measures identified by the Sec-
retary under this paragraph. 
‘‘(2) ALTERNATIVE MEASURES.—Such regula-
tion or guidance shall allow the owner, operator, or 
agent of a facility to implement an alternative pre-
ventive measure to one established by the Secretary,
provided that, in response to a request by the Sec-
retary, the owner, operator, or agent can present to 
the Secretary data or other information sufficient to 
demonstrate that the alternative measure effectively 
addresses the hazard. 
‘‘(e) REQUIREMENT TO REASSESS AND REVISE.— 
‘‘(1) REQUIREMENT.—The owner, operator, or 
agent of a facility shall— 
‘‘(A) review the food defense assessment 
under subsection (b)(1) for the facility and, as 
necessary, revise the food defense assessment 
under subsection (b)(1) for the facility— 
‘‘(i) not less than every 2 years; 
‘‘(ii) if there is a change in the proc-
ess or product that could affect the food 
defense assessment; and 
‘‘(iii) if the Secretary determines that 
it is appropriate to protect public health; 
and 
‘‘(B) whenever there is a change in the 
food defense assessment, revise the preventive 
measures under subsection (b)(2) for the facil-
ity as necessary to ensure that for all hazards 
identified, the risk is minimized, or document
(3) PROHIBITION.—Section 301(j) (21 U.S.C. 
331(j)) is amended by inserting after ‘‘entitled to 
protection’’ the following: ‘‘or a food defense plan, or 
any information derived from such a plan, under 
section 418C’’. 
SEC. 103. PERFORMANCE STANDARDS. 
(a) ADULTERATED FOOD.—Section 402 (21 U.S.C. 
342), as amended by section 102, is amended by adding 
at the end the following: 
‘‘(l) 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. 
‘‘(a) PERFORMANCE STANDARDS.—The Secretary 
shall, not less frequently than every 2 years, review and 
evaluate epidemiological data and other appropriate 
sources of information, including research 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 regu-
lation, science-based performance 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 stand-
ards shall be applicable to foods and food classes. Notwith-
standing the timelines set forth in this paragraph, the Sec-
retary shall as appropriate establish such science-based 
performance standards for identified contaminants as nec-
essary to protect the public health. 
‘‘(b) LIST OF CONTAMINANTS.—Following each re-
view under subsection (a), the Secretary shall publish in 
the Federal Register a list of food-borne contaminants 
that have the greatest adverse impact on public health. 
In determining whether a particular food-borne contami-
nant should be added to such list, the Secretary shall con-
sider the number and severity of illnesses and the number 
of deaths associated with the foods associated with such 
contaminants. 
‘‘(c) SAMPLING PROGRAM.—In conjunction with the 
establishment of a performance standard under this sec-
tion, the Secretary may make recommendations to indus-
try for conducting product sampling. 
‘‘(d) REVOCATION BY SECRETARY.—All performance 
standards of the Food and Drug Administration applicable 
to foods or food classes in effect on the date of the enact-
ment of this section, or issued under this section, shall
remain in effect until revised or revoked by the Sec-
retary.’’. 
(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 PRODUCE AND CERTAIN 
OTHER RAW AGRICULTURAL COMMODITIES. 
(a) ADULTERATED FOOD.—Section 402 (21 U.S.C. 
342), as amended by sections 102 and 103(a), is amended 
by adding at the end the following: 
‘‘(m) If it has been grown, harvested, processed, 
packed, sorted, transported, or held under conditions that 
do not meet the standards established under section 
419A.’’. 
(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, in coordination 
with the Secretary of Agriculture, shall establish by regu-
lation scientific and risk-based food safety standards for 
the growing, harvesting, processing, packing, sorting, 
transporting, and holding of those types of raw agricul-
tural commodities— 
‘‘(1) that are a fruit, vegetable, nut, or fungus; 
and 
‘‘(2) for which the Secretary has determined 
that such standards are reasonably necessary to 
minimize the risk of serious adverse health con-
sequences 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-
cluding by acts of terrorism, into raw agricul-
tural commodities that are a fruit, vegetable, 
nut, or 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, processing, packing, sorting, transporting, 
and storage operations, 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; 
‘‘(6) may provide for coordination of education 
and enforcement activities; 
‘‘(7) shall take into consideration, consistent 
with ensuring enforceable public health protection, 
the impact on small-scale and diversified farms, and 
on wildlife habitat, conservation practices, water-
shed-protection efforts, and organic production 
methods; 
‘‘(8) may provide for coordination of education 
and training with other government agencies, univer-
sities, private entities, and others with experience 
working directly with farmers; and 
‘‘(9) may provide for recognition through guid-
ance of other existing publicly available procedures, 
processes, and practices that the Secretary deter-
mines to be equivalent to those established under 
paragraph (1). 
‘‘(c) EDUCATION AND COMPLIANCE.—The Secretary 
shall coordinate with the Secretary of Agriculture to pro-
vide for effective implementation of education and compli-
ance activities. The Secretary may contract and coordinate 
with the agency or department designated by 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 (b).
(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. 
(e) UPDATE EXISTING GUIDANCE.—Not later than 
1 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. 
‘‘(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. The Secretary shall randomly inspect a cat-
egory 1 food facility at least every 6 to 12 months. 
‘‘(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 5 
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 food-borne illness outbreaks and food recalls; and 
‘‘(C) may inspect a facility more frequently 
than the inspection frequency provided by paragraph 
(4); 
‘‘(D) beginning 6 months after submitting the 
report required by section 105(b)(2) of the Food 
Safety Enhancement Act of 2009, may— 
‘‘(i) publish in the Federal Register adjust-
ments to the inspection frequencies specified in 
subparagraphs (B) and (C) of paragraph (4) 
for category 2 and category 3 food facilities, 
which adjustments shall be in accordance with 
the Secretary’s recommendations in such re-
port; and 
‘‘(ii) after such publication, implement the 
adjustments; and 
‘‘(E) except as provided in subparagraphs (B) 
and (C), may not alter the inspection frequency 
specified in paragraph (4)(A) for category 1 food fa-
cilities. 
‘‘(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; 
‘‘(C) whether the facility importing or offering 
for import into the United States food is certified by 
a qualified certifying entity in accordance with sec-
tion 801(q); and 
‘‘(D) such other factors as the Secretary deter-
mines by guidance to be relevant to assessing the 
risk presented by the facility. 
‘‘(7) Before establishing or modifying the categoriza-
tion under paragraph (4) of any food facility or type of 
food facility, the Secretary shall publish a notice of the 
proposed categorization in the Federal Register and pro-
vide a period of not less than 60 days for public comment 
on the proposed categorization.’’. 
(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 fiscal year; and 
(B) the costs of implementing the risk- 
based inspection schedule for the preceding 12 
months. 
(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 adjustments to the timing of the schedule and 
other ways to improve the risk-based allocation of 
resources by the Food and Drug Administration. In 
making such recommendations, the Secretary shall 
consider—
(A) the nature of the food products being 
processed, stored, or transported; 
(B) the manner in which food products are 
processed, stored, or transported; 
(C) the inherent likelihood that the prod-
ucts will contribute to the risk of food-borne ill-
ness; 
(D) the best available evidence concerning 
reported illnesses associated with the foods 
processed, stored, held, or transported in the 
category of facilities; and 
(E) the overall record of compliance with 
food safety law among facilities in the category, 
including compliance with applicable perform-
ance standards and the frequency of recalls. 
SEC. 106. ACCESS TO RECORDS. 
(a) RECORDS ACCESS.—Subsection (a) of section 414 
(21 U.S.C. 350c) is amended to read as follows: 
‘‘(a) RECORDS ACCESS.— 
‘‘(1) RECORDS
ACCESS
DURING
AN
INSPEC-
TION.— 
‘‘(A) IN GENERAL.—Except as provided in 
paragraph (3), each person who manufactures, 
processes, packs, transports, distributes, re-
ceives, or holds an article of food in the United
States or for import into the United States 
shall, at the request of an officer or employee 
duly designated by the Secretary, permit such 
officer or employee, upon presentation of appro-
priate credentials, at reasonable times and with-
in reasonable limits and in a reasonable man-
ner, to have access to and copy all records re-
lating to such article bearing on whether the 
food may be adulterated, misbranded, or other-
wise in violation of this Act, including all 
records collected or developed to comply with 
section 418 or 418A. 
‘‘(B) SCOPE OF RECORDS.—The require-
ment under subparagraph (A) applies to all 
records relating to the manufacture, processing, 
packing, transporting, distribution, receipt, 
holding, or importation of such article main-
tained by or on behalf of such person in any 
format (including paper and electronic formats) 
and at any location. 
‘‘(C) IMMEDIATE AVAILABILITY WITH NO-
TICE.—Records not required to be made avail-
able immediately on commencement of an in-
spection under subparagraph (A) shall nonethe-
less be made available immediately on com-
mencement of such an inspection if, by a rea-
sonable time before such inspection, the Sec-
retary by letter to the person identifies the 
records to be made available during such in-
spection. Nothing in this
subparagraph shall 
be construed as permitting a person to refuse to 
produce records required under and in accord-
ance with subparagraph (A) due to failure of 
the Secretary to provide
notice under this 
paragraph. 
‘‘(2) ADDITIONAL
AUTHORITIES
TO
ACCESS 
RECORDS REMOTELY; SUBMISSION OF RECORDS TO 
THE SECRETARY.— 
‘‘(A) REMOTE ACCESS IN EMERGENCIES.— 
If the Secretary has a reasonable belief that an 
article of food presents a threat of serious ad-
verse health consequences or death to humans 
or animals, the Secretary may require each per-
son who manufactures, processes, packs, trans-
ports, distributes, receives, holds, or imports 
such article of food, or any article of food that 
the Secretary determines may be affected in a 
similar manner, to submit to the Secretary all 
records reasonably related to such article of 
food as soon as is reasonably practicable, after
receiving written notice (including by notice 
served personally and outside normal business 
hours to an agent identified under subpara-
graph (E) or (F) of section 415(a)(2)) of such 
requirement. 
‘‘(B) REMOTE
ACCESS
TO
RECORDS
RE-
LATED TO FOOD SAFETY PLANS.—With respect 
to a facility subject to section 418 and 418A, 
the Secretary may require the owner, operator, 
or agent of such facility to submit to the Sec-
retary, as soon as reasonably practicable after 
receiving written notice of such requirement, 
the food safety plan, supporting information re-
lied on by the facility to select the preventive 
controls to include in its food safety plan, and 
documentation of corrective actions, if any, 
taken under section 418(e) within the preceding 
2 years 
‘‘(C) ELECTRONIC
SUBMISSION.—If the 
records required to be submitted to the Sec-
retary under subparagraph (A) or (B) are avail-
able in electronic format, such records shall be 
submitted electronically unless the Secretary 
specifies otherwise in the notice under such sub-
paragraph.
‘‘(3) LIMITED RECORDS ACCESS ON FARMS.— 
‘‘(A) APPLICATION.—Paragraphs (1) and 
(2) do not apply with respect to farms, except 
as provided in this paragraph. 
‘‘(B) IN GENERAL.—A person who is the 
owner, operator, or agent of a farm (as defined 
in section 415) shall, at the request of an offi-
cer or employee duly designated by the Sec-
retary, permit such officer or employee, at rea-
sonable times and within reasonable limits and 
in a reasonable manner, to have access to and 
copy all records relating to an article of food 
produced, manufactured, processed, packed, or 
held on such farm as specified in paragraphs 
(1) and (2) if— 
‘‘(i) such article of food is a fruit, veg-
etable, nut, or fungus that is the subject of 
a standard issued under section 419A; or 
‘‘(ii) such article of food is the subject 
of an active investigation by the Secretary 
of a food borne illness outbreak and is not 
a grain or similarly handled commodity as 
defined in subsection (c)(4)(C)(ii). 
‘‘(C) RECORDS ACCESS ON FARMS PRIOR 
TO RULEMAKING.—
‘‘(i) IN GENERAL.—As soon as prac-
ticable after the enactment of this para-
graph, the Secretary shall, in coordination 
with the Secretary of Agriculture, identify 
1 or more fruits, vegetables, nuts, or fungi 
for which the Secretary shall have access 
to records on farms. Such identification 
shall be made by guidance, following notice 
and public comment. 
‘‘(ii) IDENTIFICATION OF RAW AGRI-
CULTURAL COMMODITIES.—The Secretary, 
in coordination with the Secretary of Agri-
culture, shall make the identification in 
clause (i), based on any past food borne ill-
ness outbreak attributed to the fruit, vege-
table, nut, or fungus— 
‘‘(I) in the United States and the 
risk that a similar outbreak could 
occur again in the United States; or 
‘‘(II) in a foreign country and 
the risk that a similar outbreak could 
occur in the United States. 
‘‘(iii) DURATION
OF
AUTHORITY.— 
The authority to have access to records for 
a fruit, vegetable, nut, or fungus under
this subparagraph shall begin on the date 
on which the Secretary identifies such 
fruit, vegetable, nut, or fungus under 
clause (i) and shall terminate on the effec-
tive date of a final rule issued by the Sec-
retary under section 419A. 
‘‘(iv) SCOPE OF RECORDS ACCESS.— 
In the guidance under clause (i), and for 
the period specified in clause (iii), the Sec-
retary, in coordination with the Secretary 
of Agriculture, shall determine the scope of 
the records to which the Secretary shall 
have access under this subparagraph. 
‘‘(D) RULE
OF
CONSTRUCTION.—This 
paragraph shall not be construed as limiting ac-
cess to any records authorized under— 
‘‘(i) this Act or the Public Health 
Service Act, as in effect on the day before 
the date of the enactment of this para-
graph; or 
‘‘(ii) regulations issued under such 
Acts on any date before the date of the en-
actment of this paragraph.’’. 
(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, 
shall by regulation establish requirements regarding the 
establishment and maintenance, for not longer than 3 
years, of records by persons who manufacture, process, 
pack, transport, distribute, receive, or hold food in the 
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 subsection. The 
Secretary shall consult with the Secretary of Agriculture 
in promulgating regulations with respect to farms under 
this subsection and shall take into account the nature of 
and impact on farms in promulgating such regulations. 
The only distribution records which may be required of 
restaurants under this subsection are those showing the 
restaurant’s suppliers and subsequent distribution other 
than to consumers.’’. 
(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 second sentence— 
(A) by striking ‘‘(excluding farms or res-
taurants)’’ and inserting ‘‘(excluding farms, ex-
cept as provided in section 414(a)(3))’’; 
(B) 
by 
inserting 
‘‘receives,’’ 
before 
‘‘holds’’; 
(C) by striking ‘‘described in section 414’’ 
and inserting ‘‘described in or required under 
section 414’’; and 
(D) 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 
(2) 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 
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. 
‘‘(2) INFORMATION GATHERING.— 
‘‘(A) TRACING
TECHNOLOGIES.—Before 
issuing a proposed regulation under this sub-
section, the Secretary shall— 
‘‘(i) identify technologies and meth-
odologies for tracing the distribution his-
tory of a food that are, or may be, used by 
members of different sectors of the food in-
dustry, including technologies and meth-
odologies to enable each person who pro-
duces, 
manufactures, 
processes, 
pack, 
transports, or holds a food to— 
‘‘(I) maintain the full pedigree of 
the origin and previous distribution 
history of the food; 
‘‘(II) link that history with the 
subsequent distribution of the food; 
‘‘(III) establish and maintain a 
system for tracing the food that is 
interoperable with the systems estab-
lished and maintained by other such 
persons; and 
‘‘(IV) use a unique identifier for 
each facility owned or operated by 
such person for such purpose, as spec-
ified under section 1011; 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 
‘‘(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.