IIB 
111TH CONGRESS 
1ST SESSION H. R. 2749 
IN THE SENATE OF THE UNITED STATES 
AUGUST 3, 2009 
Received; read twice and referred to the Committee on Health, Education, 
Labor, and Pensions 
AN ACT 
To amend the Federal Food, Drug, and Cosmetic Act to 
improve the safety of food in the global market, and 
for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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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. 
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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— 
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(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 
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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 
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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 
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receives and distributes non-alcohol food provided such 
food is received and distributed— 
(1) in a prepackaged form that prevents any di-
rect human contact with such food; and 
(2) in amounts that constitute not more than 5 
percent of the overall sales of such facility, as deter-
mined by the Secretary of the Treasury. 
(c) RULE OF CONSTRUCTION.—This section shall not 
be construed to exempt any food, apart from distilled spir-
its, wine, and malt beverages, as defined in section 211 
of the Federal Alcohol Administration Act (27 U.S.C. 
211), from the requirements of this Act and the amend-
ments made by this Act. 
TITLE I—FOOD SAFETY 
Subtitle A—Prevention 
SEC. 101. CHANGES IN REGISTRATION OF FOOD FACILI-
TIES. 
(a) MISBRANDING.—Section 403 (21 U.S.C. 343) is 
amended by adding at the end the following: 
‘‘(z) If it was manufactured, processed, packed, or 
held in a facility that is not duly registered under section 
415, including a facility whose registration is canceled or 
suspended under such section.’’. 
(b) ANNUAL REGISTRATION.— 
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(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 
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‘‘(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; 
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‘‘(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.’’. 
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(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-
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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 
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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 
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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 if the Secretary determines that— 
‘‘(i) the registration was not updated 
in accordance with this section or other-
wise contains false, incomplete, or inac-
curate information; or 
‘‘(ii) the required registration fee has 
not been paid within 30 days after the date 
due. 
‘‘(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: 
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‘‘(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: 
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‘‘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). 
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‘‘(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- 
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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. 
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‘‘(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. 
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‘‘(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. 
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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, 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-
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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, 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— 
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‘‘(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. 
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‘‘(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. 
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‘‘(B) ALTERNATIVE CONTROLS.—Such reg-
ulation or guidance shall allow the owner, oper-
ator, or agent of a facility to implement an al-
ternative preventive control to one established 
by the Secretary, provided that, in response to 
a request by the Secretary, the owner, operator, 
or agent can present to the Secretary data or 
other information sufficient to demonstrate that 
the alternative control effectively addresses the 
hazard, including meeting any applicable per-
formance standard. 
‘‘(C) 
LIMITATION.—Subparagraph 
(B) 
shall not apply to any preventive control de-
scribed in subparagraph (A), (B), or (E) of 
subsection (i)(2). 
‘‘(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 verification shows that such controls were ineffective. 
‘‘(e) CORRECTIVE ACTIONS.—The owner, operator, 
or agent of a facility shall establish and implement proce-
dures to ensure that, if the preventive controls under sub-
section (c) are not fully implemented or are not found ef-
fective— 
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‘‘(1) no affected product from such facility en-
ters commerce; 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 system of preventive controls identified 
under subsection (c) has been validated as scientif-
ically and technically sound so that, if such system 
is implemented, the hazards identified in the hazard 
analysis under subsection (b)(3) will be prevented, 
eliminated, or reduced to an acceptable level; 
‘‘(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) REQUIREMENT.—The owner, operator, or 
agent of a facility shall— 
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‘‘(A) review the evaluation under sub-
section (b) for the facility and, as necessary, re-
vise the hazard analysis under subsection (b)(3) 
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 hazard 
analysis; and 
‘‘(iii) if the Secretary determines that 
it is appropriate to protect public health; 
and 
‘‘(B) whenever there is a change in the 
hazard analysis, revise the preventive controls 
under subsection (c) for the facility as nec-
essary to ensure that all hazards that are rea-
sonably likely to occur are prevented, elimi-
nated, or reduced to an acceptable level, or doc-
ument the basis for the conclusion that no such 
revision is needed. 
‘‘(2) NONDELEGATION.—Any revisions ordered 
by the Secretary under this subsection shall be or-
dered by the Secretary or an official designated by 
the Secretary. An official may not be so designated 
unless the official is the director of the district 
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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. 
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‘‘(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-
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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-
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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.— 
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(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. 
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(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-
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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 
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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. 
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‘‘(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. 
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‘‘(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-
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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-
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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, 
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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 
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(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 
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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 
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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: 
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‘‘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-
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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-
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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). 
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(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. 
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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. 
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‘‘(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); 
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‘‘(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— 
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‘‘(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— 
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(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— 
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(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 
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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-
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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 
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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. 
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‘‘(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.— 
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‘‘(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 
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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.— 
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(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 
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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-
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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.— 
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‘‘(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-
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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. 
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‘‘(C) PILOT PROJECTS.—Before issuing a 
proposed regulation under this subsection, the 
Secretary shall conduct 1 or more pilot projects 
in coordination with 1 or more sectors of the 
food industry to explore and evaluate tracing 
systems for food. The Secretary shall coordinate 
with the Secretary of Agriculture in conducting 
pilot projects with respect to farms under this 
subsection. 
‘‘(3) REGULATION.— 
‘‘(A) IN GENERAL.—Taking into account 
information obtained through information gath-
ering under paragraph (2), the Secretary shall 
issue regulations establishing a tracing system 
that enables the Secretary to identify each per-
son who grows, produces, manufactures, proc-
esses, packs, transports, holds, or sells such 
food in as short a timeframe as practicable but 
no longer than 2 business days. 
‘‘(B) SCOPE OF REGULATION.—The Sec-
retary may include in the regulations estab-
lishing a tracing system— 
‘‘(i) the establishment and mainte-
nance of lot numbers; 
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‘‘(ii) a standardized format for pedi-
gree information; and 
‘‘(iii) the use of a common nomen-
clature for food. 
‘‘(C) COORDINATION REGARDING FARM IM-
PACT.—In issuing regulations under this para-
graph that will impact farms, the Secretary— 
‘‘(i) shall coordinate with the Sec-
retary of Agriculture; and 
‘‘(ii) take into account the nature of 
the impact of the regulations on farms. 
‘‘(4) EXEMPTIONS AND LIMITATIONS.— 
‘‘(A) DIRECT SALES BY FARMS.—Food is 
exempt from the requirements of this sub-
section if such food is— 
‘‘(i) produced on a farm; and 
‘‘(ii) sold by the owner, operator, or 
agent in charge of such farm directly to a 
consumer or to a restaurant or grocery 
store. 
‘‘(B) FISHING VESSELS.—Food is exempt 
from the requirements of this subsection if such 
food is produced through the use of a fishing 
vessel as defined in section 3(18) of the Magnu-
son-Stevens Fishery Conservation and Manage-
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ment Act until such time as the food is sold by 
the owner, operator, or agent in charge of such 
fishing vessel. 
‘‘(C) GRAINS
AND
SIMILARLY
HANDLED 
COMMODITIES.— 
‘‘(i) LIMITATION
ON
EXTENT
OF 
TRACING.—In addition to the exemption 
under subparagraph (A), any tracing sys-
tem established under this subsection with 
regard to any grain or similarly handled 
commodity shall be limited to enabling the 
Secretary to identify persons who received, 
processed, packed, transported, distributed, 
held, or sold the grain or similarly handled 
commodity from the initial warehouse op-
erator that held the grain or similarly han-
dled commodity for any period of time to 
the ultimate consumer. 
‘‘(ii) DEFINITIONS.—In this subpara-
graph: 
‘‘(I) The term ‘grain or similarly 
handled commodity’ means wheat, 
corn, grain sorghum, barley, oats, 
rice, wild rice, rye, soybeans, legumes, 
sugar cane, sugar beets, sunflower 
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seed, 
rapeseed, 
canola, 
safflower, 
flaxseed, mustard seed, crambe, ses-
ame seed, camelina, cottonseed, cocoa 
beans, grass hay, and honey. The 
term may include any other com-
modity as determined by the Sec-
retary in coordination with the Sec-
retary of Agriculture. 
‘‘(II) The term ‘warehouse oper-
ator’ has the meaning given that term 
in section 2 of the United States 
Warehouse Act (7 U.S.C. 241), except 
that the term also includes any person 
or entity that handles or stores agri-
cultural products for other persons or 
entities or, in the case of a coopera-
tive, handles or stores agricultural 
products for its members, as deter-
mined by the Secretary in coordina-
tion with the Secretary of Agriculture. 
‘‘(D) EXEMPTION OF OTHER FOODS.—The 
Secretary may by notice in the Federal Register 
exempt a food or a type of facility, farm, or res-
taurant from, or modify the requirements with 
respect to, the requirements of this subsection 
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if the Secretary determines that a tracing sys-
tem for such food or type of facility, farm, or 
restaurant is not necessary to protect the public 
health. 
‘‘(E) RECORDKEEPING
REGARDING
PRE-
VIOUS
SOURCES
AND
SUBSEQUENT
RECIPI-
ENTS.—For a food or person covered by a limi-
tation or exemption under subparagraph (B), 
(C), or (D), the Secretary shall require each 
person who produces, receives, manufactures, 
processes, packs, transports, distributes, or 
holds such food to maintain records to identify 
the immediate previous sources of such food 
and its ingredients and the immediate subse-
quent recipients of such food. 
‘‘(F) RECORDKEEPING
BY
RESTAURANTS 
AND GROCERY STORES.—For a food covered by 
an exemption under subparagraph (A), res-
taurants and grocery stores shall keep records 
documenting the farm that was the source of 
the food. 
‘‘(G) RECORDKEEPING BY FARMS.—For a 
food covered by an exemption under subpara-
graph (A), farms shall keep records, in elec-
tronic or non-electronic format, for at least 6 
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months documenting the restaurant or grocery 
store to which the food was sold.’’. 
SEC. 108. REINSPECTION AND FOOD RECALL FEES APPLI-
CABLE TO FACILITIES. 
(a) IN GENERAL.—Part 6 of subchapter C of chapter 
VII (21 U.S.C. 371 et seq.), as added by section 101(c), 
is amended by adding at the end the following: 
‘‘SEC. 743A. REINSPECTION AND FOOD RECALL FEES APPLI-
CABLE TO FACILITIES. 
‘‘(a) IN GENERAL.—The Secretary shall assess and 
collect fees from each entity in a fiscal year— 
‘‘(1) that— 
‘‘(A) during such fiscal year commits a vio-
lation of any requirement of this Act relating to 
food, including any such requirement relating to 
good manufacturing practices; and 
‘‘(B) because of such violation, undergoes 
additional inspection by the Food and Drug Ad-
ministration; or 
‘‘(2) during such fiscal year is subject to a food 
recall. 
‘‘(b) AMOUNT OF FEES.—The Secretary shall set the 
amount of the fees under this section to fully cover the 
costs of— 
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‘‘(1) in the case of fees collected under sub-
section (a)(1), conducting the additional inspections 
referred to in such subsection; and 
‘‘(2) in the case of fees collected under sub-
section (a)(2), conducting food recall activities, in-
cluding technical assistance, follow-up effectiveness 
checks, and public notifications, during the fiscal 
year involved. 
‘‘(c) CREDITING AND AVAILABILITY OF FEES.— 
‘‘(1) IN GENERAL.—Fees authorized under sub-
section (a) shall be collected and available for obliga-
tion only to the extent and in the amount provided 
in advance in appropriations Acts. Such fees are au-
thorized to remain available until expended. Such 
sums as may be necessary may be transferred from 
the Food and Drug Administration salaries and ex-
penses appropriation account without fiscal year lim-
itation to such appropriation account for salaries 
and expenses with such fiscal year limitation. 
‘‘(2) 
COLLECTIONS
AND
APPROPRIATIONS 
ACTS.—The fees authorized by this section— 
‘‘(A) shall be retained in each fiscal year in 
an amount not to exceed the amount specified 
in appropriation Acts, or otherwise made avail-
able for obligation, for such fiscal year; and 
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‘‘(B) shall only be collected and available 
to defray the costs referred to in subsection (b). 
‘‘(3) AUTHORIZATION
OF
APPROPRIATIONS.— 
For each of fiscal years 2010 through 2014, there 
are authorized to be appropriated for fees under this 
section such sums as may be necessary. 
‘‘(d) WAIVER.—The Secretary shall waive and, if ap-
plicable, refund the amount of any fee collected under this 
section from an entity as a result of a food recall that 
the Secretary determines was inappropriately ordered.’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply to additional inspections and 
food recall activities occurring after the date of the enact-
ment of this Act. 
SEC. 109. CERTIFICATION AND ACCREDITATION. 
(a) MISBRANDING.— 
(1) IN
GENERAL.—Section 403 (21 U.S.C. 
343), as amended by section 101(a), is amended by 
adding at the end the following: 
‘‘(aa) If it is part of a shipment offered for import 
into the United States and such shipment is in violation 
of section 801(q) (requiring a certification of compliance 
for certain food shipments).’’. 
(2) EFFECTIVE DATE.—The amendment made 
by paragraph (1) shall apply to shipments offered 
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for import on or after the date that is 3 years after 
the date of the enactment of this Act. 
(b) CERTIFICATION
OF
COMPLIANCE
FOR
IM-
PORTS.—Chapter VIII (21 U.S.C. 381 et seq.) is amend-
ed— 
(1) in section 801(a), as amended by section 
107(b), by inserting after the third sentence the fol-
lowing: ‘‘If such article is food being imported or of-
fered for import into the United States and is not 
in compliance with the requirement of subsection (q) 
(relating to certifications of compliance with this 
Act), then such article shall be refused admission.’’; 
(2) in the second sentence of section 801(b), by 
striking ‘‘the fourth sentence’’ and inserting ‘‘the 
fifth sentence’’; and 
(3) by adding at the end of section 801 the fol-
lowing: 
‘‘(q) CERTIFICATIONS CONCERNING IMPORTED ARTI-
CLES.— 
‘‘(1) IN GENERAL.— 
‘‘(A) REQUIREMENT.—The Secretary may 
require, as an additional condition of granting 
admission to an article of food being imported 
or offered for import into the United States, 
that a qualified certifying entity provide a cer-
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tification that the article complies with require-
ments of this Act as specified by the Secretary 
if— 
‘‘(i) for food imported from a par-
ticular country, territory, or region, the 
Secretary finds, based on scientific, risk- 
based evidence, that the government con-
trols in such country, territory, or region 
are inadequate to ensure that the article is 
safe and that certification would assist the 
Secretary in determining whether to refuse 
to admit such article under subsection (a); 
‘‘(ii) for a type of food for which there 
is scientific evidence that there is a par-
ticular risk associated with the food that 
presents a threat of serious adverse health 
consequences or death, the Secretary finds 
that certification would assist the Sec-
retary in determining whether to refuse to 
admit such article under subsection (a); or 
‘‘(iii) for an article imported from a 
particular country or territory, there is an 
agreement between the Secretary and the 
government of such country or territory 
providing for such certification. 
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‘‘(B) FORM OF CERTIFICATION.—A certifi-
cation under subparagraph (A) may take the 
form of a statement that the article or the facil-
ity or farm that manufactured, processed, 
packed, held, grew, harvested, sorted, or trans-
ported the article, as the case may be, complies 
with requirements of this Act as specified by 
the Secretary, or any other form as the Sec-
retary may specify, including a listing of cer-
tified facilities or other entities. The Secretary 
may require that the certification include addi-
tional information regarding compliance. 
‘‘(C) 
ADEQUATE
GOVERNMENT
CON-
TROLS.— 
‘‘(i) PROCESS.—Before requiring a 
certification under clause (ii) of subpara-
graph (A) with respect to a food, the Sec-
retary shall establish a process by which a 
country or territory may demonstrate that 
its government controls are adequate to 
ensure that such food exported from its 
territory to the United States is safe. 
‘‘(ii) 
DEMONSTRATION.—The 
Sec-
retary shall not require a certification 
under clause (ii) of subparagraph (A) for 
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a food exported from a country or terri-
tory, if that country or territory has dem-
onstrated, pursuant to the process estab-
lished by the Secretary under clause (i), 
that its government controls are adequate 
to ensure that such food exported from its 
territory to the United States is safe. 
‘‘(D) NOTICE OF CANCELLATION OR SUS-
PENSION OF CERTIFICATION.—As a condition 
on acceptance of certifications from a qualified 
certifying entity, the Secretary shall require the 
qualified certifying entity to notify the Sec-
retary whenever the qualified certifying entity 
cancels or suspends the certification of any fa-
cility or other entity included in a listing under 
subparagraph (B). 
‘‘(E) CONSISTENCY WITH INTERNATIONAL 
OBLIGATIONS.—The Secretary shall apply this 
paragraph consistently with United States obli-
gations under international agreements. 
‘‘(2) QUALIFIED
CERTIFYING
ENTITY.—For 
purposes of this subsection, the term ‘qualified certi-
fying entity’ means— 
‘‘(A) an agency or a representative of the 
government of the country from which the arti-
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cle originated, as designated by such govern-
ment or the Secretary; or 
‘‘(B) an individual or entity determined by 
the Secretary or an accredited body recognized 
by the Secretary to be qualified to provide a 
certification under paragraph (1). 
‘‘(3) NO CONFLICTS OF INTEREST.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
issue regulations to ensure that any qualified 
certifying entity and its auditors are free from 
conflicts of interest. In issuing these regula-
tions, the Secretary may rely on or incorporate 
international certification standards. 
‘‘(B) 
REGULATIONS.—Such 
regulations 
shall require that— 
‘‘(i) the qualified certifying entity 
shall have a committee or management 
structure for safeguarding impartiality; 
‘‘(ii) conflict of interest policies for a 
qualified certifying entity and auditors act-
ing for the qualified certifying entity shall 
be written; 
‘‘(iii) the qualified certifying entity 
shall not be owned, operated, or controlled 
by a producer, manufacturer, processor, 
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packer, holder, supplier, or vendor of any 
article of the type it certifies; 
‘‘(iv) the qualified certifying entity 
shall not have any ownership or financial 
interest in any product, producer, manu-
facturer, processor, packer, holder, supplier 
or vendor of the type it certifies; 
‘‘(v) no auditor acting for the quali-
fied certifying entity (or spouse or minor 
children) shall have any significant owner-
ship or other financial interest regarding 
any product of the type it certifies; 
‘‘(vi) the qualified certifying entity 
shall— 
‘‘(I) obtain and maintain annual 
declarations from all personnel who 
may be directly involved in the per-
formance of audits as to whether they 
do or do not have direct financial in-
terests in any producer, manufacturer, 
processor, packer, holder, supplier, or 
vendor of foods, and a list of any such 
companies in which they do have fi-
nancial interests or by which they 
were employed in the past year; and 
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‘‘(II) when an auditor is assigned 
to audit a facility, require that indi-
vidual to affirm that he or she has no 
financial interest in the company that 
owns or operates that facility and was 
not employed by that facility in the 
previous year; 
‘‘(vii) neither the qualified certifying 
entity nor any of its auditors acting for the 
qualified certifying entity shall participate 
in the production, manufacture, processing, 
packing, holding, promotion, or sale of any 
product of the type it certifies; 
‘‘(viii) neither the qualified certifying 
entity nor any of its auditors shall provide 
consultative services to any facility cer-
tified by the qualified certifying entity, or 
the owner, operator, or agent in charge of 
such a facility, unless the qualified certi-
fying entity has procedures in place, ap-
proved by the Secretary, to ensure separa-
tion of functions between auditors pro-
viding consultative services and auditors 
providing certification services under this 
subsection; 
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‘‘(ix) no auditors acting for the quali-
fied certifying entity shall participate in an 
audit of a facility they were employed by 
within the last 12 months; 
‘‘(x) fees charged or accepted shall 
not be contingent or based upon the report 
made by the qualified certifying entity or 
any personnel involved in the audit proc-
ess; 
‘‘(xi) neither the qualified certifying 
entity nor any of its auditors shall accept 
anything of value from anyone in connec-
tion with the facility being audited other 
than the audit fee; 
‘‘(xii) the qualified certifying entity 
shall not be owned, operated, or controlled 
by a trade association whose member com-
panies operate facilities that it certifies; 
‘‘(xiii) the qualified certifying entity 
and its auditors shall be free from any 
other conflicts of interest that threaten im-
partiality; 
‘‘(xiv) the qualified certifying entity 
and its auditors shall sign a statement at-
testing to compliance with the conflict of 
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interests requirements under this para-
graph; and 
‘‘(xv) the qualified certifying entity 
shall ensure that any subcontractors that 
might be used (such as laboratories and 
sampling services) provide similar assur-
ances, except that it shall not be a viola-
tion of this subsection to the extent such 
subcontractors perform additional nutri-
tional testing services unrelated to the test-
ing under this subsection. 
‘‘(C) DEFINITIONS.—In this paragraph: 
‘‘(i) The term ‘anything of value’ in-
cludes gifts, gratuities, reimbursement of 
non-audit-related expenses, entertainment, 
loans, or any other form of compensation 
in cash or in kind. 
‘‘(ii) The term ‘direct financial inter-
est’ does not include any ownership of mu-
tual funds that have a financial interest in 
a company. 
‘‘(4) RENEWAL
AND
REFUSAL
OF
CERTIFI-
CATIONS.—The Secretary shall— 
‘‘(A) require that, to the extent applicable, 
any certification provided by a qualified certi-
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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) ON-SITE AUDITS.—In evaluating whether 
an accreditation body meets, or continues to meet, 
the standards for recognition under this subsection, 
or whether to accept certifications from a qualified 
certifying entity, the Secretary may— 
‘‘(A) observe on-site audits of qualified cer-
tifying entities by such accreditation body; or 
‘‘(B) for any facility that is certified by a 
qualified certifying entity, upon request of an 
officer or employee designated by the Secretary 
and upon presentation of appropriate creden-
tials, at reasonable times and within reasonable 
limits and in a reasonable manner, conduct an 
on-site audit of the facility, which shall include 
access to, and copying and verification of, any 
related records. 
‘‘(6) ELECTRONIC SUBMISSION.—The Secretary 
shall provide, in coordination with the Commissioner 
responsible for Customs and Border Protection, for 
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the electronic submission of certifications under this 
subsection. 
‘‘(7) NO
LIMIT
ON
AUTHORITY.—This sub-
section shall not be construed to limit the authority 
of the Secretary to conduct random inspections of 
imported articles or facilities of importers, issue im-
port alerts for detention without physical examina-
tion, require submission to the Secretary of docu-
mentation or other information about an article im-
ported or offered for import, or to take such other 
steps as the Secretary deems appropriate to deter-
mine the admissibility of imported articles.’’. 
SEC. 110. TESTING BY ACCREDITED LABORATORIES. 
(a) PROHIBITED ACT.—Section 301 (21 U.S.C. 331) 
is amended by adding at the end the following: 
‘‘(uu) The violation of any requirement of section 714 
(relating to testing by accredited laboratories).’’. 
(b) LABORATORY ACCREDITATION.—Subchapter A of 
chapter VII (21 U.S.C. 371 et seq.) is amended by adding 
at the end the following: 
‘‘SEC. 714. TESTING BY ACCREDITED LABORATORIES. 
‘‘(a) IN GENERAL.— 
‘‘(1) REQUIREMENT.—Whenever analytical test-
ing of an article of food is conducted as part of testi-
mony for the purposes of section 801(a), or for such 
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other purposes as the Secretary deems appropriate 
through regulation or guidance, such testing shall be 
conducted by a laboratory that— 
‘‘(A) is accredited, for the analytical meth-
od used, by a laboratory accreditation body that 
has been recognized by the Secretary; and 
‘‘(B) samples such article with adequate 
controls for ensuring the integrity of the sam-
ples analyzed. 
‘‘(2) INDEPENDENCE OF LABORATORY.— 
‘‘(A) CERTAIN TESTS.—Tests required for 
purposes of section 801(a) or in response to a 
finding of noncompliance by the Secretary shall 
be conducted by a laboratory independent of the 
person on whose behalf such testing is con-
ducted and analyzed. 
‘‘(B) CERTAIN PRODUCTS.—The Secretary 
may require that testing for certain products 
under paragraph (1) be conducted by a labora-
tory independent of the person on whose behalf 
such testing is conducted. 
‘‘(b) RECOGNITION OF LABORATORY ACCREDITATION 
BODIES.—The Secretary shall establish and implement a 
program for the recognition, based on standards the Sec-
retary deems appropriate, of laboratory accreditation bod-
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ies that accredit laboratories to perform analytical testing 
for the purposes of this section. The Secretary shall issue 
regulations or guidance to implement this program. 
‘‘(c) ONSITE AUDITS.—In evaluating whether an ac-
creditation body meets, or continues to meet, the stand-
ards for recognition under subsection (b), the Secretary 
may— 
‘‘(1) observe onsite audits of laboratories by 
such accreditation bodies; or 
‘‘(2) for any laboratory that is accredited by 
such accreditation body under this section, upon re-
quest of an officer or employee designated by the 
Secretary and upon presentation of appropriate cre-
dentials, at reasonable times and within reasonable 
limits and in a reasonable manner, conduct an onsite 
audit of the laboratory, which shall include access to, 
and copying and verification of, any related records. 
‘‘(d) PUBLICATION OF LIST OF RECOGNIZED AC-
CREDITATION BODIES.—The Secretary shall publish and 
maintain on the public Web site of the Food and Drug 
Administration a list of accreditation bodies recognized by 
the Secretary under subsection (b). 
‘‘(e) NOTIFICATION OF ACCREDITATION OF LABORA-
TORY.—An accreditation body that has been recognized 
pursuant to this section shall promptly notify the Sec-
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retary whenever it accredits a laboratory for the purposes 
of this section and whenever it withdraws or suspends 
such accreditation. 
‘‘(f) ADVANCE NOTICE.—Whenever analytical testing 
is conducted pursuant to subsection (a), the person on 
whose behalf the testing is conducted shall notify the Sec-
retary before any sample of the article is collected. Such 
notice shall contain information the Secretary determines 
is appropriate to identify the article, the location of the 
article, and each laboratory that will analyze the sample 
on the person’s behalf. 
‘‘(g) CONTENTS
OF
LABORATORY
PACKAGES.— 
Whenever analytical testing is conducted pursuant to sub-
section (a), the laboratory conducting such testing shall 
submit, directly to the Secretary— 
‘‘(1) the results of all analyses conducted by the 
laboratory on each sample of such article; and 
‘‘(2) all information the Secretary deems appro-
priate to— 
‘‘(A) determine whether the laboratory is 
accredited by a recognized laboratory accredita-
tion body; 
‘‘(B) identify the article tested; 
‘‘(C) evaluate the analytical results; and 
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‘‘(D) determine whether the requirements 
of this section have been met. 
‘‘(h) EXIGENT
CIRCUMSTANCES.—The Secretary 
may waive the requirement of subsection (a)(1)(A) (relat-
ing to analytical methods) on a laboratory or method basis 
due to exigent or other circumstances. 
‘‘(i) FEDERAL LABORATORY TESTING.—If Customs 
and Border Protection laboratory testing concludes that 
an article of food is adulterated or misbranded, the Sec-
retary shall consider and utilize as appropriate the testing 
results issued by the Customs and Border Protection lab-
oratories in making a decision about the admissibility of 
the product. 
‘‘(j) NO LIMIT ON AUTHORITY.—Nothing in this sec-
tion shall be construed to limit— 
‘‘(1) the ability of the Secretary to review and 
act upon information from the analytical testing of 
food (including under this section), including deter-
mining the sufficiency of such information and test-
ing; or 
‘‘(2) the authority of the Secretary to conduct, 
require, or consider the results of analytical testing 
pursuant to any other provision of law.’’. 
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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: 
‘‘(vv)(1) The failure to notify the Secretary in viola-
tion of section 420(a). 
‘‘(2) The failure to comply with any order issued 
under section 420.’’. 
(b) NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED FOOD.—Chapter IV 
(21 U.S.C. 341 et seq.), as amended by sections 102, 103, 
and 104, is amended by adding at the end the following: 
‘‘SEC. 420. NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED FOOD. 
‘‘(a) NOTIFICATION, NONDISTRIBUTION, AND RE-
CALL OF ADULTERATED OR MISBRANDED FOOD.— 
‘‘(1) IN GENERAL.—A responsible party as that 
term is defined in section 417(a)(1) or a person re-
quired to register under section 801(s) that has rea-
son to believe that an article of food when intro-
duced into or while in interstate commerce, or while 
held for sale (regardless of whether the first sale) 
after shipment in interstate commerce, is adulter-
ated or misbranded in a manner that presents a rea-
sonable probability that the use or consumption of, 
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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 serious 
adverse health consequences or death to humans or ani-
mals, the Secretary shall have the authority to issue an 
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order requiring any person who distributes such article to 
immediately cease distribution of such article. 
‘‘(d) ACTION FOLLOWING ORDER.—Any person who 
is subject to an order under subsection (c) shall imme-
diately cease distribution of such article and provide notifi-
cation as required by such order, and may appeal within 
24 hours of issuance such order to the Secretary. Such 
appeal may include a request for an informal hearing and 
a description of any efforts to recall such article under-
taken voluntarily by the person, including after a request 
under subsection (b). Except as provided in subsection (f), 
an informal hearing shall be held as soon as practicable, 
but not later than 5 calendar days, or less as determined 
by the Secretary, after such an appeal is filed, unless the 
parties jointly agree to an extension. After affording an 
opportunity for an informal hearing, the Secretary shall 
determine whether the order should be amended to require 
a recall of such article. If, after providing an opportunity 
for such a hearing, the Secretary determines that inad-
equate grounds exist to support the actions required by 
the order, the Secretary shall vacate the order. 
‘‘(e) ORDER TO RECALL.— 
‘‘(1) AMENDMENT.—Except as provided under 
subsection (f), if after providing an opportunity for 
an informal hearing under subsection (d), the Sec-
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retary determines that the order should be amended 
to include a recall of the article with respect to 
which the order was issued, the Secretary shall 
amend the order to require a recall. 
‘‘(2) CONTENTS.—An amended order under 
paragraph (1) shall— 
‘‘(A) specify a timetable in which the recall 
will occur; 
‘‘(B) require periodic reports to the Sec-
retary describing the progress of the recall; and 
‘‘(C) provide for notice, including to indi-
viduals as appropriate, to persons who may be 
affected by the recall. 
In providing for such notice, the Secretary may 
allow for the assistance of health professionals, State 
or local officials, or other individuals designated by 
the Secretary. 
‘‘(3) NONDELEGATION.—An amended order 
under this subsection shall be ordered by the Sec-
retary or an official designated by the Secretary. An 
official may not be so designated unless the official 
is the director of the district under this Act in which 
the article involved is located, or is an official senior 
to such director. 
‘‘(f) EMERGENCY RECALL ORDER.— 
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‘‘(1) IN GENERAL.—If the Secretary has cred-
ible evidence or information that an article of food 
subject to an order under subsection (c) presents an 
imminent threat of serious adverse health con-
sequences or death to humans or animals, the Sec-
retary may issue an order requiring any person who 
distributes such article— 
‘‘(A) to immediately recall such article; and 
‘‘(B) to provide for notice, including to in-
dividuals as appropriate, to persons who may be 
affected by the recall. 
‘‘(2) ACTION FOLLOWING ORDER.—Any person 
who is subject to an emergency recall order under 
this subsection shall immediately recall such article 
and provide notification as required by such order, 
and may appeal within 24 hours after issuance such 
order to the Secretary. An informal hearing shall be 
held within as soon as practicable but not later than 
5 calendar days, or less as determined by the Sec-
retary, after such an appeal is filed, unless the par-
ties jointly agree to an extension. After affording an 
opportunity for an informal hearing, the Secretary 
shall determine whether the order should be amend-
ed pursuant to subsection (e)(1). If, after providing 
an opportunity for such a hearing, the Secretary de-
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termines that inadequate grounds exist to support 
the actions required by the order, the Secretary shall 
vacate the order. 
‘‘(3) NONDELEGATION.—An order under this 
subsection shall be issued by the Commissioner of 
Food and Drugs, the Principal Deputy Commis-
sioner, or the Associate Commissioner for Regu-
latory Affairs of the Food and Drug Administration. 
‘‘(g) NOTICE TO CONSUMERS AND HEALTH OFFI-
CIALS.—The Secretary shall, as the Secretary determines 
to be necessary, provide notice of a recall order under this 
section to consumers to whom the article was, or may have 
been, distributed and to appropriate State and local health 
officials. 
‘‘(h) SAVINGS CLAUSE.—Nothing contained in this 
section shall be construed as limiting— 
‘‘(1) the authority of the Secretary to issue an 
order to cease distribution of, or to recall, an article 
under any other provision of this Act or the Public 
Health Service Act; or 
‘‘(2) the ability of the Secretary to request any 
person to perform a voluntary activity related to any 
article subject to this Act or the Public Health Serv-
ice Act.’’. 
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(c) ARTICLES SUBJECT
TO REFUSAL.—The third 
sentence of subsection (a) of section 801 (21 U.S.C. 381), 
as amended by section 107(b), is amended by inserting 
‘‘or (5) such article is subject to an order under section 
420 to cease distribution of or recall the article,’’ before 
‘‘then such article shall be refused admission’’. 
(d) EFFECTIVE DATE.—Sections 301(vv)(1) and 420 
of the Federal Food, Drug, and Cosmetic Act, as added 
by subsections (a) and (b), shall apply with respect to arti-
cles of food as of such date, not later than 1 year after 
the date of the enactment of this Act, as the Secretary 
of Health and Human Services shall specify. 
SEC. 112. REPORTABLE FOOD REGISTRY; EXCHANGE OF IN-
FORMATION. 
(a) REPORTABLE FOOD REGISTRY.—Section 417 (21 
U.S.C. 350f) is amended— 
(1) in subsection (a)(1), by striking ‘‘means a 
person’’ and all that follows through the end of 
paragraph (1) and inserting the following: ‘‘means— 
‘‘(A) a person who submits the registration 
under section 415(a) for a food facility that is 
required to be registered under section 415(a), 
at which such food is manufactured, processed, 
packed, or held; 
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‘‘(B) a person who owns, operates, is an 
agent of, or is otherwise responsible for such 
food on a farm (as such term is defined in sec-
tion 1.227(b)(3) of title 21, Code of Federal 
Regulations, or successor regulations) at which 
such food is produced for sale or distribution in 
interstate commerce; 
‘‘(C) a person who owns, operates, or is an 
agent of a restaurant or other retail food estab-
lishment (as such terms are defined in section 
1.227(b)(11) and (12), respectively, of title 21, 
Code of Federal Regulations, or successor regu-
lations) at which such food is offered for sale; 
or 
‘‘(D) a person that is required to register 
pursuant to section 801(s) with respect to im-
portation of such food.’’; 
(2) in subsection (b), by adding at the end the 
following: 
‘‘(3) REPORTING
BY
FARMS, RESTAURANTS, 
AND RETAIL FOOD ESTABLISHMENTS.—In addition 
to the electronic portal described in paragraph (1), 
the Secretary shall make available alternative means 
of reporting under this section with respect to farms, 
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restaurants, and other retail food establishments 
with limited ability for such reporting.’’; 
(3) in subsection (d)(1)— 
(A) in the matter preceding subparagraph 
(A), by inserting ‘‘following a timely review of 
any reasonably available data and information,’’ 
after ‘‘reportable food,’’; 
(B) in subparagraph (A), by striking 
‘‘and’’ at the end; 
(C) by redesignating subparagraph (B) as 
subparagraph (C); and 
(D) by inserting after subparagraph (A) 
the following: 
‘‘(B) submit, with such report, through the 
electronic portal, documentation of results from 
any sampling and testing of such article, includ-
ing— 
‘‘(i) analytical results from testing of 
such article conducted by or on behalf of 
the responsible party under section 418, 
418A, 419, 419A, or 714; 
‘‘(ii) analytical results from testing 
conducted by or on behalf of such respon-
sible party of a component of such article; 
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‘‘(iii) analytical results of environ-
mental testing of any facility at which such 
article, or a component of such article, is 
manufactured, processed, packed, or held; 
and 
‘‘(iv) any other information the Sec-
retary determines is necessary to evaluate 
the adulteration of such article, any com-
ponent of such article, any other article of 
food manufactured, processed, packed or 
held in the same manner as, or at the 
same facility as, such article, or any other 
article containing a component from the 
same source as a component of such arti-
cle; and’’; and 
(4) in subsection (e)— 
(A) in paragraph (1), by inserting ‘‘if the 
responsible party is required to register’’ after 
‘‘415(a)(3)’’; and 
(B) by adding at the end the following: 
‘‘(12) Such additional information as the Sec-
retary deems appropriate.’’. 
(b) EXCHANGE OF INFORMATION.—Section 708 (21 
U.S.C. 379) is amended— 
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(1) by striking ‘‘The Secretary’’ and inserting 
‘‘(a) The Secretary’’; and 
(2) by adding at the end the following: 
‘‘(b)(1)(A) The Secretary may provide to any Federal 
agency acting within the scope of its jurisdiction any infor-
mation relating to food that is exempt from disclosure pur-
suant to subsection (a) of section 552 of title 5, United 
States Code, by reason of subsection (b)(4) of such sec-
tion, or that is referred to in section 301(j) or 415(a)(4). 
‘‘(B) Any such information provided to another Fed-
eral agency shall not be disclosed by such agency except 
in any action or proceeding under the laws of the United 
States to which the receiving agency or the United States 
is a party. 
‘‘(2)(A) In carrying out this Act, the Secretary may 
provide to a State or local government agency any infor-
mation relating to food that is exempt from disclosure pur-
suant to section 552(a) of title 5, United States Code, by 
reason of subsection (b)(4) of such section, or that is re-
ferred to in section 301(j) or 415(a)(4). 
‘‘(B) Any such information provided to a State or 
local government agency shall not be disclosed by such 
agency. 
‘‘(3) In carrying out this Act, the Secretary may pro-
vide to any person any information relating to food that 
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is exempt from disclosure pursuant to section 552(a) of 
title 5, United States Code, by reason of subsection (b)(4) 
of such section, if the Secretary determines that providing 
the information to the person is appropriate under the cir-
cumstances and the recipient provides adequate assur-
ances to the Secretary that the recipient will preserve the 
confidentiality of the information. 
‘‘(4) In carrying out this Act, the Secretary may pro-
vide any information relating to food that is exempt from 
disclosure pursuant to section 552(a) of title 5, United 
States Code, by reason of subsection (b)(4) of such sec-
tion, or that is referred to in section 301(j)— 
‘‘(A) to any foreign government agency; or 
‘‘(B) any international organization established 
by law, treaty, or other governmental action and 
having responsibility— 
‘‘(i) to facilitate global or regional harmo-
nization of standards and requirements in an 
area of responsibility of the Food and Drug Ad-
ministration; or 
‘‘(ii) to promote and coordinate public 
health efforts, 
if the agency or organization provides adequate as-
surances to the Secretary that the agency or organi-
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zation will preserve the confidentiality of the infor-
mation. 
‘‘(c) Except where specifically prohibited by statute, 
the Secretary may disclose to the public any information 
relating to food that is exempt from disclosure pursuant 
to section 552(a) of title 5, United States Code, by reason 
of subsection (b)(4) of such section, if the Secretary deter-
mines that such disclosure is necessary to protect the pub-
lic health. 
‘‘(d) Except as provided in subsection (e), the Sec-
retary shall not be required to disclose under section 552 
of title 5, United States Code, or any other provision of 
law any information relating to food obtained from a Fed-
eral, State, or local government agency, or from a foreign 
government agency, or from an international organization 
described in subsection (b)(4), if the agency or organiza-
tion has requested that the information be kept confiden-
tial, or has precluded such disclosure under other use limi-
tations, as a condition of providing the information. 
‘‘(e) Nothing in subsection (d) authorizes the Sec-
retary to withhold information from the Congress or pre-
vents the Secretary from complying with an order of a 
court of the United States. 
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‘‘(f) This section shall not affect the authority of the 
Secretary to provide or disclose information under any 
other provision of law.’’. 
(c) CONFORMING AMENDMENT.—Section 301(j) (21 
U.S.C. 331(j)) is amended by striking ‘‘or to the courts 
when relevant in any judicial proceeding under this Act,’’ 
and inserting ‘‘to the courts when relevant in any judicial 
proceeding under this Act, or as specified in section 708,’’. 
SEC. 113. SAFE AND SECURE FOOD IMPORTATION PRO-
GRAM. 
Chapter VIII (21 U.S.C. 381 et seq.) is amended by 
adding at the end the following: 
‘‘SEC. 805. SAFE AND SECURE FOOD IMPORTATION PRO-
GRAM. 
‘‘(a) IN GENERAL.—The Secretary may establish by 
regulation or guidance in coordination with the Commis-
sioner responsible for Customs and Border Protection a 
program that facilitates the movement of food through the 
importation process under this Act if the importer of such 
food— 
‘‘(1) verifies that each facility involved in the 
production, manufacture, processing, packaging, and 
holding of the food is in compliance with the food 
safety and security guidelines developed under sub-
section (b) with respect to such food; 
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‘‘(2) ensures that appropriate safety and secu-
rity controls are in place throughout the supply 
chain for such food; and 
‘‘(3) provides supporting information to the 
Secretary. 
‘‘(b) GUIDELINES.— 
‘‘(1) DEVELOPMENT.—For purposes of the pro-
gram established under subsection (a), the Secretary 
shall develop in consultation with the Commissioner 
responsible for Customs and Border Protection safe-
ty and security guidelines applicable to the importa-
tion of food taking into account, to the extent appro-
priate, other relevant Federal programs, such as the 
Customs-Trade Partnership Against Terrorism (C- 
TPAT) programs under section 211 of the Security 
and Accountability for Every Port Act of 2006. 
‘‘(2) FACTORS.—Such guidelines shall take into 
account the following factors: 
‘‘(A) The personnel of the person import-
ing the food. 
‘‘(B) The physical and procedural safety 
and security of such person’s food supply chain. 
‘‘(C) The sufficiency of preventive controls 
for food and ingredients purchased by such per-
son. 
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‘‘(D) Vendor and supplier information. 
‘‘(E) Other programs for certification or 
verification by a qualified certifying entity used 
by the importer. 
‘‘(F) Such other factors as the Secretary 
determines necessary.’’. 
SEC. 114. INFANT FORMULA. 
(a) MISBRANDING.—Section 403 (21 U.S.C. 343), as 
amended by sections 101(a) and 109(a), is amended by 
adding at the end the following: 
‘‘(bb) If it is a new infant formula and— 
‘‘(1) it is not the subject of a registration made 
pursuant to section 412(c)(1)(A); 
‘‘(2) it is not the subject of a submission made 
pursuant to section 412(c)(1)(B), or 
‘‘(3) at least 90 days have not passed since the 
making of such registration or of such submission to 
the Secretary.’’. 
(b) REQUIREMENTS.—Section 412 (21 U.S.C. 350a) 
is amended— 
(1) in subsection (c)(1)(B), by striking ‘‘(c)(1)’’ 
at the end and inserting ‘‘(d)(1), subject to sub-
section (d)(2)(B)’’; 
(2) in subsection (d)(1)— 
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(A) by striking ‘‘and’’ at the end of sub-
paragraph (C); 
(B) by striking the period at the end of 
subparagraph (D) and inserting ‘‘, and’’; and 
(C) by adding at the end the following: 
‘‘(E) information on any new ingredient in 
accordance with paragraph (2)(A).’’; 
(3) in subsection (d), by redesignating para-
graphs (2) and (3) as paragraphs (3) and (4), re-
spectively; and 
(4) by inserting after paragraph (1) of sub-
section (d) the following: 
‘‘(2)(A) The description of any new infant formula 
required under paragraph (1) shall include, for any new 
ingredient for use in the formula— 
‘‘(i) a citation to a prior approval by the Sec-
retary of the new ingredient for use in infant for-
mula under section 409; 
‘‘(ii) a citation to or information showing a 
prior consideration of the new ingredient for use in 
infant formula under any program established by the 
Secretary for the review of ingredients used in food; 
or 
‘‘(iii) for a new ingredient that is not a food ad-
ditive or a color additive, information equivalent to 
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that provided under any program established by the 
Secretary for the review of ingredients used in food. 
‘‘(B) If the information submitted under subpara-
graph (A) is the information described in clause (iii) of 
such subparagraph, the 90 day period provided by sub-
section (c)(1)(B) shall not commence until the Secretary 
has completed review of the information submitted under 
such clause and has provided the submitter notice of the 
results of such review.’’. 
Subtitle B—Intervention 
SEC. 121. SURVEILLANCE. 
(a) DEFINITION
OF FOOD-BORNE ILLNESS OUT-
BREAK.—In this section, the term ‘‘food-borne illness out-
break’’ means the occurrence of 2 or more cases of a simi-
lar illness resulting from the ingestion of a food. 
(b) FOOD-BORNE
ILLNESS
SURVEILLANCE
SYS-
TEMS.—The Secretary of Health and Human Services (in 
this subtitle referred to as the ‘‘Secretary’’), acting 
through the Director of the Centers for Disease Control 
and Prevention, shall enhance food-borne illness surveil-
lance systems to improve the collection, analysis, report-
ing, and usefulness of data on food-borne illnesses by— 
(1) coordinating Federal, State, and local food- 
borne illness surveillance systems, including com-
plaint systems, and increasing participation in na-
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tional networks of public health and food regulatory 
agencies and laboratories; 
(2) facilitating sharing of findings on a more 
timely basis among governmental agencies, including 
the Food and Drug Administration, the Department 
of Agriculture, and State and local agencies, and 
with the public; 
(3) developing improved epidemiological tools 
for obtaining quality exposure data, and micro-
biological methods for classifying cases; 
(4) augmenting such systems to improve attri-
bution of a food-borne illness outbreak to a specific 
food; 
(5) expanding capacity of such systems, includ-
ing fingerprinting and other detection strategies for 
food-borne infectious agents, in order to identify new 
or rarely documented causes of food-borne illness; 
(6) allowing timely public access to aggregated, 
de-identified surveillance data; 
(7) at least annually, publishing current reports 
on findings from such systems; 
(8) establishing a flexible mechanism for rapidly 
initiating scientific research by academic institu-
tions; 
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(9) integrating food-borne illness surveillance 
systems and data with other biosurveillance and 
public health situational awareness capabilities at 
the Federal, State, and local levels; and 
(10) other activities as determined appropriate 
by the Secretary. 
(c) IMPROVING FOOD SAFETY AND DEFENSE CAPAC-
ITY AT THE STATE AND LOCAL LEVEL.— 
(1) IN GENERAL.—The Secretary shall develop 
and implement strategies to leverage and enhance 
the food safety and defense capacities of State and 
local agencies in order to achieve the following goals: 
(A) Improve food-borne illness outbreak re-
sponse and containment. 
(B) Accelerate food-borne illness surveil-
lance and outbreak investigation, including 
rapid shipment of clinical isolates from clinical 
laboratories to appropriate State laboratories, 
and conducting more standardized illness out-
break interviews. 
(C) Strengthen the capacity of State and 
local agencies to carry out inspections and en-
force safety standards. 
(D) Improve the effectiveness of Federal, 
State, and local partnerships to coordinate food 
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safety and defense resources and reduce the in-
cidence of food-borne illness. 
(E) Share information on a timely basis 
among public health and food regulatory agen-
cies, with the food industry, with health care 
providers, and with the public. 
(2) REVIEW.—In developing the strategies re-
quired by paragraph (1), the Secretary shall, not 
later than 1 year after the date of enactment of this 
Act, complete a review of State and local capacities, 
and needs for enhancement, which may include a 
survey with respect to— 
(A) staffing levels and expertise available 
to perform food safety and defense functions; 
(B) laboratory capacity to support surveil-
lance, outbreak response, inspection, and en-
forcement activities; 
(C) information systems to support data 
management and sharing of food safety and de-
fense information among State and local agen-
cies and with counterparts at the Federal level; 
and 
(D) other State and local activities and 
needs as determined appropriate by the Sec-
retary. 
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SEC. 122. PUBLIC EDUCATION AND ADVISORY SYSTEM. 
(a) PUBLIC EDUCATION.—The Secretary, in coopera-
tion with private and public organizations, including the 
appropriate State entities, shall design and implement a 
national public education program on food safety. The 
program shall provide— 
(1) information to the public so that individuals 
can understand the potential impact and risk of 
food-borne illness, take action to reduce their risk of 
food-borne illness and injury, and make healthy die-
tary choices; 
(2) information to health professionals so that 
they may improve diagnosis and treatment of food- 
related illness and advise individuals whose health 
conditions place them in particular risk; and 
(3) such other information or advice to con-
sumers and other persons as the Secretary deter-
mines will promote the purposes of this Act. 
(b) HEALTH ADVISORIES.—The Secretary shall work 
with the States and other appropriate entities to— 
(1) develop and distribute regional and national 
advisories concerning food safety; 
(2) develop standardized formats for written 
and broadcast advisories; and 
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(3) incorporate State and local advisories into 
the national public education program required 
under subsection (a). 
SEC. 123. RESEARCH. 
The Secretary shall conduct research to assist in the 
implementation of this Act, including studies to— 
(1) improve sanitation and food safety practices 
in the production, harvesting, and processing of food 
products; 
(2) develop improved techniques for the moni-
toring of food and inspection of food products; 
(3) develop efficient, rapid, and sensitive meth-
ods for determining and detecting the presence of 
contaminants in food products; 
(4) determine the sources of contamination of 
food and food products, including critical points of 
risk for fresh produce and other raw agricultural 
commodities; 
(5) develop consumption data with respect to 
food products; 
(6) draw upon research and educational pro-
grams that exist at the State and local level; 
(7) utilize the DNA matching system and other 
processes to identify and control pathogens; 
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(8) address common and emerging zoonotic dis-
eases; 
(9) develop methods to reduce or destroy patho-
gens before, during, and after processing; 
(10) analyze the incidence of antibiotic resist-
ance as it pertains to the food supply and evaluate 
methods to reduce the transfer of antibiotic resist-
ance to humans; and 
(11) conduct other research that supports the 
purposes of this Act. 
Subtitle C—Response 
SEC. 131. PROCEDURES FOR SEIZURE. 
Section 304(b) (21 U.S.C. 334(b)) is amended by in-
serting ‘‘and except that, with respect to proceedings relat-
ing to food, Rule G of the Supplemental Rules of Admi-
ralty or Maritime Claims and Asset Forfeiture Actions 
shall not apply in any such case, exigent circumstances 
shall be deemed to exist for all seizures brought under this 
section, and the summons and arrest warrant shall be 
issued by the clerk of the court without court review in 
any such case’’ after ‘‘in any such case shall be tried by 
jury’’. 
SEC. 132. ADMINISTRATIVE DETENTION. 
(a) AMENDMENTS.—Section 304(h) (21 U.S.C. 
334(h)) is amended— 
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(1) in paragraph (1)(A), by striking ‘‘credible 
evidence or information indicating’’ and inserting 
‘‘reason to believe’’; 
(2) in paragraph (1)(A), by striking ‘‘presents 
a threat of serious adverse health consequences or 
death to humans or animals’’ and inserting ‘‘is adul-
terated, misbranded, or otherwise in violation of this 
Act’’; 
(3) in paragraph (2), by striking ‘‘30’’ and in-
serting ‘‘60’’; 
(4) in paragraph (3), by striking the third sen-
tence; and 
(5) in paragraph (4)(A) by striking the terms 
‘‘five’’ and ‘‘five-day’’ and inserting ‘‘fifteen’’ and 
‘‘fifteen-day’’, respectively. 
(b) REGULATIONS.—The Secretary shall issue regula-
tions or guidance to implement the amendments made by 
this section. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall take effect 180 days after the date of 
the enactment of this Act. 
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SEC. 133. AUTHORITY TO PROHIBIT OR RESTRICT THE 
MOVEMENT OF FOOD. 
(a) PROHIBITED ACT.—Section 301 (21 U.S.C. 331), 
as amended by sections 110 and 111, is amended by add-
ing at the end by adding the following: 
‘‘(ww) The violation of a prohibition or restriction 
under section 304(i).’’. 
(b) IN GENERAL.—Section 304 (21 U.S.C. 334) is 
amended by adding at the end the following: 
‘‘(i) AUTHORITY TO PROHIBIT OR RESTRICT THE 
MOVEMENT OF FOOD WITHIN A STATE OR PORTION OF 
A STATE.— 
‘‘(1) AUTHORITY
TO
PROHIBIT
OR
RESTRICT 
THE MOVEMENT OF FOOD.— 
‘‘(A) IN GENERAL.— 
‘‘(i) After consultation with the Gov-
ernor or other appropriate official of an af-
fected State, if the Secretary determines 
that there is credible evidence that an arti-
cle of food presents an imminent threat of 
serious adverse health consequences or 
death to humans or animals, the Secretary 
may prohibit or restrict the movement of 
an article of food within a State or portion 
of a State for which the Secretary has 
credible evidence that such food is located 
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within, or originated from, such State or 
portion thereof. 
‘‘(ii) In carrying out clause (i), the 
Secretary may prohibit or restrict the 
movement within a State or portion of a 
State of any article of food or means of 
conveyance of such article of food, if the 
Secretary determines that the prohibition 
or restriction is a necessary protection 
from an imminent threat of serious adverse 
health consequences or death to humans or 
animals. 
‘‘(2) NOTIFICATION PROCEDURES.—Subject to 
paragraph (3), before any action is taken in a State 
under this subsection, the Secretary shall— 
‘‘(A) notify the Governor or other appro-
priate official of the State affected by the pro-
posed action; 
‘‘(B) issue a public announcement of the 
proposed action; and 
‘‘(C) publish in the Federal Register— 
‘‘(i) the findings of the Secretary that 
support the proposed action; 
‘‘(ii) a statement of the reasons for 
the proposed action; and 
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‘‘(iii) a description of the proposed ac-
tion, including— 
‘‘(I) the area affected; and 
‘‘(II) an estimate of the antici-
pated duration of the action. 
‘‘(3) NOTICE AFTER ACTION.—If it is not prac-
ticable to publish in the Federal Register the infor-
mation required under paragraph (2)(C) before tak-
ing action under paragraph (1), the Secretary shall 
publish the information as soon as practicable, but 
not later than 10 business days, after commence-
ment of the action. 
‘‘(4) APPLICATION
OF
LEAST
DRASTIC
AC-
TION.—No action shall be taken under paragraph 
(1) unless, in the opinion of the Secretary, there is 
no less drastic action that is feasible and that would 
be adequate to prevent the imminent threat of seri-
ous adverse health consequences or death to humans 
or animals. 
‘‘(5) NONDELEGATION.—An action under para-
graph (1) may only be ordered by the Secretary or 
an official designated by the Secretary. An official 
may not be so designated unless the official is the 
Commissioner of Food and Drugs or the Principal 
Deputy Commissioner. 
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‘‘(6) DURATION.—Fourteen days after the initi-
ation of an action under paragraph (1), and each 14 
days thereafter, if the Secretary determines that it 
is necessary to continue the action, the Secretary 
shall— 
‘‘(A) notify the Governor or other appro-
priate official of the State affected of the con-
tinuation of the action; 
‘‘(B) issue a public announcement of the 
continuation of the action; and 
‘‘(C) publish in the Federal Register the 
findings of the Secretary that support the con-
tinuation of the action, including an estimate of 
the anticipated duration of the action. 
‘‘(7) RULEMAKING.—The Secretary shall, con-
sistent with national security interests and as appro-
priate for known hazards, establish by regulation 
standards for conducting actions under paragraph 
(1), including, as appropriate, sanitation standards 
and procedures to restore any affected equipment or 
means of conveyance to its status prior to an action 
under paragraph (1).’’. 
SEC. 134. CRIMINAL PENALTIES. 
Section 303(a) (21 U.S.C. 333) is amended— 
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(1) in paragraph (1), by striking ‘‘Any’’ and in-
serting ‘‘Except as provided in paragraph (2) or (3), 
any’’; and 
(2) by adding at the end the following: 
‘‘(3) Notwithstanding paragraph (1), any person who 
knowingly violates paragraph (a), (b), (c), (k), or (v) of 
section 301 with respect to any food that is misbranded 
or adulterated shall be imprisoned for not more than 10 
years or fined in accordance with title 18, United States 
Code, or both.’’. 
SEC. 135. CIVIL PENALTIES FOR VIOLATIONS RELATING TO 
FOOD. 
(a) IN GENERAL.—Paragraph (2) of section 303(f) 
(21 U.S.C. 331 et seq.) is amended to read as follows: 
‘‘(2)(A) Any person who violates a provision of 
section 301 relating to food shall be subject to a civil 
penalty for each such violation of not more than— 
‘‘(i) $20,000 in the case of an individual, 
not to exceed $50,000 in a single proceeding; 
and 
‘‘(ii) $250,000 in the case of any other 
person, not to exceed $1,000,000 in a single 
proceeding. 
‘‘(B) Any person who knowingly violates a pro-
vision of section 301 relating to food shall be subject 
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to a civil penalty for each such violation of not more 
than— 
‘‘(i) $50,000 in the case of an individual, 
not to exceed $100,000 in a single proceeding; 
and 
‘‘(ii) $500,000 in the case of any other 
person, not to exceed $7,500,000 in a single 
proceeding. 
‘‘(C) Each violation described in subparagraph 
(A) or (B) and each day during which the violation 
continues shall be considered to be a separate of-
fense.’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) applies to violations committed on or after 
the date of the enactment of this Act. 
SEC. 136. IMPROPER IMPORT ENTRY FILINGS. 
(a) PROHIBITED ACTS.—Section 301 (21 U.S.C. 
331), as amended by sections 110, 111, and 133, is 
amended by adding at the end the following: 
‘‘(xx) The submission of information relating to food 
that is required by or under section 801 that is inaccurate 
or incomplete. 
‘‘(yy) The failure to submit information relating to 
food that is required by or under section 801.’’. 
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(b) DOCUMENTATION FOR IMPORTS.—Section 801 
(21 U.S.C. 381), as amended by section 109, is amended 
by adding at the end the following: 
‘‘(r) DOCUMENTATION.— 
‘‘(1) SUBMISSION.—The Secretary may require 
by regulation or guidance the submission of docu-
mentation or other information for articles of food 
that are imported or offered for import into the 
United States. When developing any regulation or 
guidance in accordance with this paragraph, to the 
extent that the collection of documentation or other 
information involves Customs and Border Protection 
efforts or resources, the Secretary shall consult with 
Customs and Border Protection. 
‘‘(2) FORMAT.—A regulation or guidance under 
paragraph (1) may specify the format for submission 
of the documentation or other information.’’. 
TITLE II—MISCELLANEOUS 
SEC. 201. FOOD SUBSTANCES GENERALLY RECOGNIZED AS 
SAFE. 
Section 409 (21 U.S.C. 348) is amended by adding 
at the end the following: 
‘‘Substances Generally Recognized as Safe 
‘‘(k)(1) Not later than 60 days after the date of re-
ceipt by the Secretary, after the date of the enactment 
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of this subsection, of a determination that a substance is 
a GRAS food substance, the Secretary shall post notice 
of such determination and the supporting scientific jus-
tifications on the Food and Drug Administration’s public 
Web site. 
‘‘(2) Not later than 60 days after the date of receipt 
of a request under paragraph (1), the Secretary shall ac-
knowledge receipt of such request by informing the re-
quester in writing of the date on which the request was 
received. 
‘‘(3) In this subsection, the term ‘GRAS food sub-
stance’ means a substance excluded from the definition of 
the term ‘food additive’ in section 201(s) because such 
substance is generally recognized, among experts qualified 
by scientific training and experience to evaluate its safety, 
as having been adequately shown through scientific proce-
dures (or, in the case of a substance used in food prior 
to January 1, 1958, through either scientific procedures 
or experience based on common use in food) to be safe 
under the conditions of its intended use.’’. 
SEC. 202. COUNTRY OF ORIGIN LABELING. 
(a) MISBRANDING.—Section 403 (21 U.S.C. 343), as 
amended by sections 101(a), 109(a), and 114(a), is 
amended by adding at the end the following: 
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‘‘(cc) In the case of a processed food, if the labeling 
of the food fails to identify the country in which the final 
processing of the food occurs. 
‘‘(dd) In the case of nonprocessed food, if the labeling 
of the food fails to identify the country of origin of the 
food.’’. 
(b) REGULATIONS.— 
(1) PROMULGATION.—Not later than 180 days 
after the date of the enactment of this Act, the Sec-
retary of Health and Human Services shall promul-
gate final regulations to carry out paragraphs (cc) 
and (dd) of section 403 of the Federal Food, Drug, 
and Cosmetic Act, as added by subsection (a). 
(2) RELATION
TO
OTHER
REQUIREMENTS.— 
Regulations promulgated under paragraph (1) shall 
provide that labeling meets the requirements of 
paragraphs (cc) and (dd) of section 403 of the Fed-
eral Food, Drug, and Cosmetic Act, as added by 
subsection (a), if— 
(A) in the case of a processed food, the 
label of the food informs the consumer of the 
country where the final processing of the food 
occurred in accordance with country of origin 
marking requirements of the United States 
Customs and Border Protection; or 
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(B) in the case of a nonprocessed food, the 
label of the food informs the consumer of the 
country of origin of the food in accordance with 
labeling requirements of the Department of Ag-
riculture. 
(c) EFFECTIVE DATE.—The requirements of para-
graphs (cc) and (dd) of section 403 of the Federal Food, 
Drug, and Cosmetic Act, as added by subsection (a), take 
effect on the date that is 2 years after the date of the 
enactment of this Act. 
SEC. 203. EXPORTATION CERTIFICATE PROGRAM. 
Section 801(e)(4) (21 U.S.C. 381) is amended— 
(1) in the matter preceding clause (i) in sub-
paragraph (A)— 
(A) by inserting ‘‘from the United States’’ 
after ‘‘exports’’; and 
(B) by striking ‘‘a drug, animal drug, or 
device’’ and inserting ‘‘a food (including animal 
feed), drug, animal drug, or device’’; 
(2) in subparagraph (A)(i)— 
(A) by striking ‘‘in writing’’; and 
(B) by striking ‘‘exported drug, animal 
drug, or device’’ and inserting ‘‘exported food, 
drug, animal drug, or device’’; 
(3) in subparagraph (A)(ii)— 
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(A) by striking ‘‘in writing’’; 
(B) by striking ‘‘the drug, animal drug, or 
device’’ and inserting ‘‘the food, drug, animal 
drug, or device’’; and 
(C) by striking ‘‘the drug or device’’ and 
inserting ‘‘the food, drug, or device’’; 
(4) by redesignating subparagraph (B) as sub-
paragraph (C); 
(5) by inserting after subparagraph (A) the fol-
lowing: 
‘‘(B) For purposes of this paragraph, a 
certification by the Secretary shall be made on 
such basis and in such form (such as a publicly 
available listing) as the Secretary determines 
appropriate.’’; and 
(6) by adding at the end the following: 
‘‘(D) Notwithstanding subparagraph (C), if the Sec-
retary issues an export certification within the 20 days 
prescribed by subparagraph (A) with respect to the export 
of food, a fee for such certification shall not exceed such 
amount as the Secretary determines is reasonably related 
to the cost of issuing certificates under subparagraph (A) 
with respect to the export of food. The Secretary may ad-
just this fee annually to account for inflation and other 
cost adjustments. Fees collected for a fiscal year pursuant 
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to this subparagraph shall be credited to the appropriation 
account for salaries and expenses of the Food and Drug 
Administration and shall be available in accordance with 
appropriations Acts until expended, without fiscal year 
limitation. Such fees shall be collected in each fiscal year 
in an amount equal to the amount specified in appropria-
tions Acts for such fiscal year and shall only be collected 
and available for the costs of the Food and Drug Adminis-
tration to cover the cost of issuing such certifications. 
Such sums as necessary may be transferred from such ap-
propriation account for salaries and expenses of the Food 
and Drug Administration without fiscal year limitation to 
such appropriation account for salaries and expenses with 
fiscal year limitation.’’. 
SEC. 204. REGISTRATION FOR COMMERCIAL IMPORTERS 
OF FOOD; FEE. 
(a) REGISTRATION.— 
(1) PROHIBITIONS.—Section 301 (21 U.S.C. 
331), as amended by sections 110, 111, 133, and 
136, is amended by adding at the end the following: 
‘‘(zz) The failure to register in accordance with sec-
tion 801(s).’’. 
(2) MISBRANDING.—Section 403 (21 U.S.C. 
343) as amended by sections 101(a), 109(a), 114(a), 
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and 202, is amended by adding at the end the fol-
lowing: 
‘‘(ee) If it is imported or offered for import by an 
importer not duly registered under section 801(s).’’. 
(3) REGISTRATION.—Section 801, as amended 
by sections 109 and 136, is amended by adding at 
the end the following: 
‘‘(s) REGISTRATION OF IMPORTERS.— 
‘‘(1) REGISTRATION.—The Secretary shall re-
quire an importer of food— 
‘‘(A) to be registered with the Secretary in 
a form and manner specified by the Secretary; 
and 
‘‘(B) consistent with section 1011, to sub-
mit appropriate unique facility identifiers as a 
condition of registration. 
‘‘(2) GOOD IMPORTER PRACTICES.—The main-
tenance of registration under this subsection is con-
ditioned on compliance with good importer practices 
in accordance with the following: 
‘‘(A) The Secretary, in consultation with 
Customs and Border Protection, shall promul-
gate regulations to establish good importer 
practices that specify the measures an importer 
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tion in the safe and secure food importa-
tion program under section 805; and 
‘‘(ii) take into account differences 
among importers and the types of imports, 
including based on the level of risk posed 
by the imported food. 
‘‘(3) SUSPENSION OF REGISTRATION.— 
‘‘(A) IN
GENERAL.—Registration under 
this subsection is subject to suspension upon a 
finding by the Secretary, after notice and an 
opportunity for an informal hearing, of— 
‘‘(i) a violation of this Act; or 
‘‘(ii) the knowing or repeated making 
of an inaccurate or incomplete statement 
or submission of information relating to 
the importation of food. 
‘‘(B) REQUEST.—The importer whose reg-
istration is suspended may request that the 
Secretary vacate the suspension of registration 
when such importer has corrected the violation 
that is the basis for such suspension. 
‘‘(C) VACATING OF SUSPENSION.—If the 
Secretary determines that adequate reasons do 
not exist to continue the suspension of a reg-
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istration, the Secretary shall vacate such sus-
pension. 
‘‘(4) CANCELLATION OF REGISTRATION.— 
‘‘(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 im-
porter of the intent to cancel the registration 
and the basis for such cancellation. 
‘‘(C) TIMELY UPDATE OR CORRECTION.— 
If the registration for the importer is updated 
or corrected no later than 7 days after notice 
is provided under subparagraph (B), the Sec-
retary shall not cancel such registration. 
‘‘(5) EXEMPTIONS.—The Secretary, by notice 
published in the Federal Register— 
‘‘(A) shall establish an exemption from the 
requirements of this subsection for importations 
for personal use; and 
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‘‘(B) may establish other exemptions from 
the requirements of this subsection.’’. 
(4) REGULATIONS.—Not later than 36 months 
after the date of the enactment of this Act, the Sec-
retary of Health and Human Services in consulta-
tion with the Commissioner responsible for Customs 
and Border Protection shall promulgate the regula-
tions required to carry out section 801(s) of the 
Federal Food, Drug, and Cosmetic Act, as added by 
paragraph (3). In establishing the effective date of 
a regulation promulgated under section 801(s), the 
Secretary shall, in consultation with the Commis-
sioner responsible for Customs and Border Protec-
tion, as appropriate, provide a reasonable period of 
time for importers of food to comply with good im-
porter practices, taking into account differences 
among importers and the types of imports, including 
based on the level of risk posed by the imported 
food. 
(5) EFFECTIVE DATE.—The amendments made 
by this subsection shall take effect on the date that 
is 24 months after the date of enactment of this Act. 
(b) FEE.—Subchapter C of chapter VII (21 U.S.C. 
379f et seq.) as added and amended by sections 101 and 
108, is amended by adding at the end the following: 
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‘‘PART 7—IMPORTERS OF FOOD 
‘‘SEC. 744. IMPORTERS OF FOOD. 
‘‘(a) IMPORTERS.—The Secretary shall assess and 
collect an annual fee for the registration of an importer 
of food under section 801(s). 
‘‘(b) AMOUNT OF FEE.— 
‘‘(1) BASE
AMOUNTS.—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 paragraph (2). 
‘‘(2) ADJUSTMENT.—For fiscal year 2011 and 
subsequent fiscal years, the fees established pursu-
ant to paragraph (1) shall be adjusted by the Sec-
retary by notice, published in the Federal Register, 
for a fiscal year to reflect the greater of— 
‘‘(A) the total percentage change that oc-
curred in the Consumer Price Index for all 
urban consumers (all items; United States city 
average), for the 12-month period ending June 
30 preceding the fiscal year for which fees are 
being established; 
‘‘(B) the total percentage change for the 
previous fiscal year in basic pay under the Gen-
eral Schedule in accordance with section 5332 
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of title 5, United States Code, as adjusted by 
any locality-based comparability payment pur-
suant to section 5304 of such title for Federal 
employees stationed in the District of Columbia; 
or 
‘‘(C) 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 pre-
ceding 6 fiscal years. 
‘‘(3) COMPOUNDED
BASIS.—The adjustment 
made each fiscal year pursuant this subsection shall 
be added on a compounded basis to the sum of all 
adjustments made each fiscal year after fiscal year 
2010 under this subsection. 
‘‘(4) WAIVER
FOR
IMPORTERS
REQUIRED
TO 
PAY REGISTRATION FEE.—In the case of a person 
who is required to pay both a fee under section 743 
for registration of one or more facilities under sec-
tion 415 and a fee under this section for registration 
as an importer of food under section 801(s), the 
Secretary shall waive the fees applicable to such per-
son under section 743 or the fee applicable to such 
person under this section. 
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‘‘(c) CREDITING AND AVAILABILITY OF FEES.— 
‘‘(1) IN GENERAL.—Fees authorized under sub-
section (a) shall be collected and available for obliga-
tion only to the extent and in the amount provided 
in advance in appropriations Acts. Such fees are au-
thorized to remain available until expended. Such 
sums as may be necessary may be transferred from 
the Food and Drug Administration salaries and ex-
penses appropriation account without fiscal year lim-
itation to such appropriation account for salaries 
and expenses with such fiscal year limitation. 
‘‘(2) 
COLLECTIONS
AND
APPROPRIATIONS 
ACTS.—The fees authorized by this section— 
‘‘(A) shall be retained in each fiscal year in 
an amount not to exceed the amount specified 
in appropriation Acts, or otherwise made avail-
able for obligation, for such fiscal year; and 
‘‘(B) shall only be collected and available 
to cover the costs associated with registering 
importers under section 801(s) and with ensur-
ing compliance with good importer practices re-
specting food. 
‘‘(3) AUTHORIZATION
OF
APPROPRIATIONS.— 
For each of fiscal years 2010 through 2014, there 
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are authorized to be appropriated for fees under this 
section such sums as may be necessary.’’. 
(c) INSPECTION.—Section 704 (21 U.S.C. 374), as 
amended by section 105, is amended by adding at the end 
the following: 
‘‘(i) IMPORTERS.—Every person engaged in the im-
porting of any food shall, upon request of an officer or 
employee designated by the Secretary, permit such officer 
or employee at all reasonable times to inspect the facilities 
of such person and have access to, and to copy and verify, 
any related records.’’. 
SEC. 205. REGISTRATION FOR CUSTOMS BROKERS. 
(a) REGISTRATION.— 
(1) 
PROHIBITIONS.—Section 
301(zz) 
(21 
U.S.C. 331), as added by section 204, is amended 
by inserting ‘‘or 801(t)’’ after ‘‘801(s)’’. 
(2) MISBRANDING.—Section 403(ee) (21 U.S.C. 
343), as added by section 204, is amended— 
(A) by inserting ‘‘or a customs broker’’ 
after ‘‘by an importer’’; and 
(B) 
by 
inserting 
‘‘or 
801(t)’’ 
after 
‘‘801(s)’’. 
(3) REGISTRATION.—Section 801, as amended 
by sections 109, 136, and 204, is amended by add-
ing at the end the following: 
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‘‘(t) REGISTRATION OF CUSTOMS BROKER.— 
‘‘(1) REGISTRATION.—The Secretary shall re-
quire a customs broker, with respect to the importa-
tion of food— 
‘‘(A) to be registered with the Secretary in 
a form and manner specified by the Secretary; 
and 
‘‘(B) consistent with section 1011, to sub-
mit appropriate unique facility identifiers as a 
condition of registration. 
‘‘(2) CANCELLATION OF REGISTRATION.— 
‘‘(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 cus-
toms broker of the intent to cancel the registra-
tion and the basis for such cancellation. 
‘‘(C) TIMELY UPDATE OR CORRECTION.— 
If the registration for the customs broker is up-
dated or corrected no later than 7 days after 
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notice is provided under subparagraph (B), the 
Secretary shall not cancel such registration. 
‘‘(3) NOTIFICATION.—The Secretary shall no-
tify the Commissioner responsible for Customs and 
Border Protection whenever the Secretary cancels a 
registration under this subsection. 
‘‘(4) EXEMPTIONS.—In consultation with the 
Commissioner responsible for Customs and Border 
Protection, the Secretary, by notice published in the 
Federal Register— 
‘‘(A) shall establish an exemption from the 
requirements of this subsection for importations 
for personal use; and 
‘‘(B) may establish other exemptions from 
the requirements of this subsection. 
‘‘(5) CIVIL PENALTIES.—Notwithstanding any 
other provision in this Act, a customs broker who 
violates section 301 because of a violation of section 
403(ee), or who violates section 301(xx), 301(yy), or 
301(zz), shall not be subject to a civil penalty under 
section 303(f)(2).’’. 
(4) REGULATIONS.—Not later than 24 months 
after the date of the enactment of this Act, the Sec-
retary of Health and Human Services, in consulta-
tion with the Commissioner responsible for Customs 
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and Border Protection, shall promulgate the regula-
tions required to carry out section 801(t) of the 
Federal Food, Drug, and Cosmetic Act, as added by 
paragraph (2). 
(5) EFFECTIVE DATE.—The amendments made 
by this subsection shall take effect on the date that 
is 24 months after the date of enactment of this Act. 
(b) INSPECTION.—Section 704 (21 U.S.C. 374), as 
amended by sections 105 and 204, is amended by adding 
at the end the following: 
‘‘(j) BROKERS.—Every customs broker required to be 
registered with the Secretary shall, upon request of an of-
ficer or employee designated by the Secretary, permit such 
officer or employee at all reasonable times to inspect the 
facilities of such person and have access to, and to copy 
and verify, any related records.’’. 
SEC. 206. UNIQUE IDENTIFICATION NUMBER FOR FOOD FA-
CILITIES, IMPORTERS, AND CUSTOM BRO-
KERS. 
Chapter X (21 U.S.C. 391 et seq) is amended by add-
ing at the end the following: 
‘‘SEC. 1011. UNIQUE FACILITY IDENTIFIER. 
‘‘(a) REGISTRATION OF FACILITY OR ESTABLISH-
MENT.—A person required to register a facility pursuant 
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to section 415 shall submit, at the time of registration, 
a unique facility identifier for the facility or establishment. 
‘‘(b) REGISTRATION OF IMPORTERS AND CUSTOM 
BROKERS.—A person required to register pursuant to sec-
tion 801(s) or 801(t) shall submit, at the time of registra-
tion, a unique facility identifier for the principal place of 
business for which such person is required to register 
under section 801(s) or 801(t). 
‘‘(c) GUIDANCE.—The Secretary may, by guidance, 
and, with respect to importers and customs brokers, in 
consultation with the Commissioner responsible for Cus-
toms and Border Protection, specify the unique numerical 
identifier system to be used to meet the requirements of 
subsections (a) and (b) and the form, manner, and timing 
of a submission under such subsections. Development of 
such guidelines shall take into account the utilization of 
existing unique identification schemes and compatibility 
with customs automated systems, such as integration with 
the Automated Commercial Environment (ACE) and the 
International Trade Data System (ITDS), and any suc-
cessor systems. 
‘‘(d) IMPORTATION.—An article of food imported or 
offered for import shall be refused admission unless the 
appropriate unique facility identifiers, as specified by the 
Secretary, are provided for such article.’’. 
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SEC. 207. PROHIBITION AGAINST DELAYING, LIMITING, OR 
REFUSING INSPECTION. 
(a) ADULTERATION.—Section 402 (21 U.S.C. 342), 
as amended by section 102, 103(a), and 104(a), is amend-
ed by adding at the end the following: 
‘‘(n) If it has been produced, manufactured, proc-
essed, packed, or held in any farm, factory, warehouse, 
or establishment and the owner, operator, or agent of such 
farm, factory, warehouse, or establishment, or any agent 
of a governmental authority in the foreign country within 
which such farm, factory, warehouse, or establishment is 
located, delays or limits an inspection, or refuses to permit 
entry or inspection, under section 414 or 704.’’. 
(b) FOREIGN INSPECTIONS.—Section 704(a)(1) (21 
U.S.C. 374(a)(1)), as amended by section 106(c), is 
amended— 
(1) in the first sentence, by inserting ‘‘, includ-
ing any such food factory, warehouse, or establish-
ment whether foreign or domestic,’’ after ‘‘factory, 
warehouse, or establishment’’; and 
(2) in the third sentence, by inserting ‘‘, includ-
ing any food factory, warehouse, establishment, or 
consulting laboratory whether foreign or domestic,’’ 
after ‘‘factory, warehouse, establishment, or con-
sulting laboratory’’. 
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SEC. 208. DEDICATED FOREIGN INSPECTORATE. 
Section 704 (21 U.S.C. 374), as amended by sections 
105, 204, and 205, is amended by adding at the end the 
following: 
‘‘(k) DEDICATED FOREIGN INSPECTORATE.—The 
Secretary shall establish and maintain a corps of inspec-
tors dedicated to inspections of foreign food facilities. This 
corps shall be staffed and funded by the Secretary at a 
level sufficient to enable it to assist the Secretary in 
achieving the frequency of inspections for food facilities 
as described in this Act.’’. 
SEC. 209. PLAN AND REVIEW OF CONTINUED OPERATION 
OF FIELD LABORATORIES. 
(a) SUBMISSION OF PLAN.—Not later than 90 days 
before the Secretary terminates or consolidates any lab-
oratory, district office, or the functions (including the in-
spection and compliance functions) of any such laboratory 
or district office, specified in subsection (b), the Secretary 
shall submit a reorganization plan to the Comptroller Gen-
eral of the United States, the Committee on Energy and 
Commerce of the House of Representatives, and the Com-
mittee on Health, Education, Labor, and Pensions of the 
Senate. 
(b) SPECIFIED LABORATORIES AND OFFICES.—The 
laboratories and offices specified in this subsection are the 
following: 
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(1) Any of the 13 field laboratories responsible 
for analyzing food that were operated by the Office 
of Regulatory Affairs of the Food and Drug Admin-
istration as of January 1, 2007. 
(2) Any of the 20 district offices of the Food 
and Drug Administration with responsibility for food 
safety functioning as of January 1, 2007. 
(c) CONGRESSIONAL
REVIEW.—A reorganization 
plan described in subsection (a) is deemed to be a major 
rule (as defined in section 804(2) of title 5, United States 
Code) for purposes of chapter 8 of such title. 
SEC. 210. FALSE OR MISLEADING REPORTING TO FDA. 
(a) IN GENERAL.—Section 301(q)(2) (21 U.S.C. 
331(q)(2)) is amended by inserting after ‘‘device’’ the fol-
lowing: ‘‘, food,’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply to submissions made on or after 
the date of the enactment of this Act. 
SEC. 211. SUBPOENA AUTHORITY. 
(a) PROHIBITED ACT.—Section 301(f) is amended by 
inserting before the period ‘‘or the failure or refusal to 
obey a subpoena issued pursuant to section 311’’. 
(b) AMENDMENT.—Chapter III (21 U.S.C. 331 et 
seq.) is amended by adding at the end the following: 
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‘‘SEC. 311. EXERCISE OF SUBPOENA AUTHORITY. 
‘‘(a) IN GENERAL.—For the purpose of— 
‘‘(1) any hearing, investigation, or other pro-
ceeding respecting a violation of a provision of this 
Act, the Public Health Service Act, or the Federal 
Anti-Tampering Act, relating to food; or 
‘‘(2) any hearing, investigation, or other pro-
ceeding to determine if a person is in violation of a 
specific provision of this Act, the Public Health 
Service Act, or the Federal Anti-Tampering Act, re-
lating to food, 
the Commissioner may issue subpoenas requiring the at-
tendance and testimony of witnesses and the production 
of records and other things. 
‘‘(b) TIMING OF COMPLIANCE.—When the Commis-
sioner deems that immediate compliance with a subpoena 
issued under this section is necessary to address a threat 
of serious adverse health consequences or death, the sub-
poena may require immediate production. 
‘‘(c) SERVICE OF SUBPOENA.— 
‘‘(1) IN GENERAL.—Subpoenas of the Commis-
sioner shall be served by a person authorized by the 
Commissioner by delivering a copy thereof to the 
person named therein or by certified mail addressed 
to such person at such person’s last known dwelling 
place or principal place of business. 
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‘‘(2) CORPORATIONS AND OTHER ENTITIES.— 
Service on a domestic or foreign corporation, part-
nership, unincorporated association, or other entity 
that is subject to suit under a common name may 
be made by delivering the subpoena to an officer, a 
managing or general agent, or any other agent au-
thorized by appointment or by law to receive service 
of process. 
‘‘(3) PERSON
OUTSIDE
U.S. JURISDICTION.— 
Service on any person not found within the terri-
torial jurisdiction of any court of the United States 
may be made in any manner as the Federal Rules 
of Civil Procedure prescribe for service in a foreign 
nation. 
‘‘(4) PROOF OF SERVICE.—A verified return by 
the person so serving the subpoena setting forth the 
manner of service, or, in the case of service by cer-
tified mail, the return post office receipt therefor 
signed by the person so served, shall be proof of 
service. 
‘‘(d) PAYMENT OF WITNESSES.—Witnesses subpoe-
naed under subsection (a) shall be paid the same fees and 
mileage as are paid witnesses in the district courts of the 
United States. 
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‘‘(e) ENFORCEMENT.—In the case of a refusal to 
obey a subpoena duly served upon any person under sub-
section (a), any district court of the United States for the 
judicial district in which such person charged with refusal 
to obey is found, resides, or transacts business, upon ap-
plication by the Commissioner, shall have jurisdiction to 
issue an order compelling compliance with the subpoena 
and requiring such person to appear and give testimony 
or to appear and produce records and other things, or 
both. The failure to obey such order of the court may be 
punished by the court as contempt thereof. If the person 
charged with failure or refusal to obey is not found within 
the territorial jurisdiction of the United States, the United 
States District Court for the District of Columbia shall 
have the same jurisdiction, consistent with due process, 
to take any action respecting compliance with the sub-
poena by such person that such district court would have 
if such person were personally within the jurisdiction of 
such district court. 
‘‘(f) NONDISCLOSURE.—A United States district 
court for the district in which the subpoena is or will be 
served, upon application of the Commissioner, may issue 
an ex parte order that no person or entity disclose to any 
other person or entity (other than to an attorney to obtain 
legal advice) the existence of such subpoena for a period 
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of up to 90 days. Such order may be issued on a showing 
that the records or things being sought may be relevant 
to the hearing, investigation, proceeding, or other matter 
and that there is reason to believe that such disclosure 
may result in— 
‘‘(1) furtherance of a potential violation under 
investigation; 
‘‘(2) endangerment to the life or physical safety 
of any person; 
‘‘(3) flight or other action to avoid prosecution 
or other enforcement remedies; 
‘‘(4) destruction of or tampering with evidence; 
or 
‘‘(5) intimidation of potential witnesses. 
An order under this subsection may be renewed for addi-
tional periods of up to 90 days upon a showing that any 
of the circumstances described in paragraphs (1) through 
(5) continue to exist. 
‘‘(g) RELATION TO OTHER PROVISIONS.—The sub-
poena authority vested in the Commissioner and the dis-
trict courts of the United States by this section is in addi-
tion to any such authority vested in the Commissioner or 
such courts by other provisions of
law, or as is otherwise 
authorized by law. 
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‘‘(h) NONDELEGATION.—The authority to issue a 
subpoena under this section is limited to the Secretary or 
an official designated by the Secretary. An official may 
not be so designated unless the official is the director of 
the district under this Act in which the article involved 
is located, or is an official senior to such director.’’. 
SEC. 212. WHISTLEBLOWER PROTECTIONS. 
Chapter X (21 U.S.C. 391 et seq.), as amended by 
section 206, is amended by adding at the end the fol-
lowing: 
‘‘SEC. 1012 PROTECTIONS FOR EMPLOYEES WHO REFUSE 
TO VIOLATE, OR WHO DISCLOSE VIOLATIONS 
OF, THIS ACT. 
‘‘(a) IN GENERAL.—No person who submits or is re-
quired under this Act or the Public Health Service Act 
to submit any information related to a food, or any officer, 
employee, contractor, subcontractor, or agent of such per-
son may discharge, demote, suspend, threaten, harass, or 
in any other manner discriminate against an employee in 
the terms and conditions of employment because of any 
lawful act done by the employee, including within the ordi-
nary course of the job duties of such employee— 
‘‘(1) to provide information, cause information 
to be provided, or otherwise assist in any investiga-
tion regarding any conduct which the employee rea-
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sonably believes constitutes a violation of this Act, or 
any other provision of Federal law relating to the 
safety of a food, if the information or assistance is 
provided to, or an investigation stemming from the 
provided information is conducted by— 
‘‘(A) a Federal regulatory or law enforce-
ment agency; 
‘‘(B) any Member of Congress or any com-
mittee of Congress; or 
‘‘(C) a person with supervisory authority 
over the employee (or such other person work-
ing for the employer who has the authority to 
investigate, discover, or terminate the mis-
conduct); 
‘‘(2) to file, cause to be filed, testify, participate 
in, or otherwise assist in a proceeding filed, or about 
to be filed (with any knowledge of the employer), in 
any court or administrative forum relating to any 
such alleged violation; or 
‘‘(3) to refuse to commit or assist in any such 
violation. 
‘‘(b) ENFORCEMENT ACTION.— 
‘‘(1) IN GENERAL.—An employee who alleges 
discharge or other discrimination in violation of sub-
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section (a) may seek relief in accordance with the 
provisions of subsection (c) by— 
‘‘(A) filing a complaint with the Secretary 
of Labor; or 
‘‘(B) if the Secretary of Labor has not 
issued a final decision within 210 days of the 
filing of the complaint and there is no showing 
that such delay is due to the bad faith of the 
claimant, or within 90 days after receiving a 
final decision or order from the Secretary, 
bringing an action at law or equity for de novo 
review in the appropriate district court of the 
United States, which court shall have jurisdic-
tion over such action without regard to the 
amount in controversy, and which action shall, 
at the request of either party to such action, be 
tried by the court with a jury. 
‘‘(2) PROCEDURE.— 
‘‘(A) IN
GENERAL.—Any action under 
paragraph (1) shall be governed under the rules 
and procedures set forth in section 42121(b) of 
title 49, United States Code. 
‘‘(B) EXCEPTION.—Notification in an ac-
tion under paragraph (1) shall be made in ac-
cordance with section 42121(b)(1) of title 49, 
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United States Code, except that such notifica-
tion shall be made to the person named in the 
complaint, the employer, and the Commissioner 
of Food and Drugs. 
‘‘(C) BURDENS
OF
PROOF.—An action 
brought under paragraph (1)(A) or (1)(B) shall 
be governed by the legal burdens of proof set 
forth in section 42121(b) of title 49, United 
States Code. 
‘‘(D) STATUTE OF LIMITATIONS.—An ac-
tion under paragraph (1)(A) shall be com-
menced not later than 180 days after the date 
on which the violation occurs. 
‘‘(c) REMEDIES.— 
‘‘(1) IN GENERAL.—An employee prevailing in 
any action under subsection (b)(1) shall be entitled 
to all relief necessary to make the employee whole. 
‘‘(2) ISSUANCE OF ORDER.—If, in response to 
a complaint filed under paragraph (b)(1), the Sec-
retary of Labor or the district court, as applicable, 
determines that a violation of subsection (a) has oc-
curred, the Secretary or the court shall order the 
person who committed such violation— 
‘‘(A) to take affirmative action to abate 
the violation; 
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‘‘(1) the broad range of ceramicware types, in-
cluding traditional pottery, ornamental and decora-
tive ceramicware, cookware, and everyday dinner-
ware; 
‘‘(2) the safety of ceramicware that is aged or 
damaged; 
‘‘(3) the use of ceramicware in microwave 
ovens; 
‘‘(4) the storage of foods in ceramicware; 
‘‘(5) the use of home lead test kits by con-
sumers; 
‘‘(6) the use of ceramicware by children and 
women of childbearing age; and 
‘‘(7) issues that are especially relevant to sub-
populations of consumers who may preferentially use 
certain types of ceramicware made with lead.’’. 
Passed the House of Representatives July 30, 2009. 
Attest: 
LORRAINE C. MILLER, 
Clerk. 
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