established to generate a total revenue amount 
under subsection (a). 
‘‘(2) TOTAL
REVENUE
AMOUNT.—Not later 
than September 1, 2009, the Secretary shall trans-
mit to the Congress the total revenue amount under 
paragraph (1) and how such amount was calculated. 
‘‘(3) ANNUAL
FEE
SETTING.—The Secretary 
shall, not later than 60 days before the start of each 
fiscal year that begins after September 30, 2009, es-
tablish, for the next fiscal year, registration fees 
under subsection (a) based on the total revenue 
amount applicable under paragraph (1). 
‘‘(c) ADJUSTMENTS.— 
‘‘(1) INFLATION ADJUSTMENT.—For fiscal year 
2011 and subsequent fiscal years, the revenues es-
tablished under subsection (b)(1) shall be adjusted 
by the Secretary 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; U.S. city average) 
for the 12-month period ending June 30 pre-
ceding the fiscal year for which fees are being 
established; 
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‘‘(B) the total percentage change for the 
previous fiscal year in basic pay under the Gen-
eral Schedule in accordance with section 5332 
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. 
The adjustment made each fiscal year under this 
subsection shall be added on a compounded basis to 
the sum of all adjustments made each fiscal year 
after fiscal year 2009 under this subsection. 
‘‘(2) WORKLOAD
ADJUSTMENT.—For fiscal 
year 2011 and subsequent fiscal years, after the fee 
revenues established under subsection (b)(1) are ad-
justed for a fiscal year for inflation in accordance 
with paragraph (1), the fee revenues shall be ad-
justed further for such fiscal year to reflect changes 
in the workload of the Secretary for inspections and 
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related activities described in subsection (a). With 
respect to such adjustment: 
‘‘(A) The adjustment shall be determined 
by the Secretary based on a weighted average 
of the change in the total amount of inspections 
and related activities described in subsection 
(a). The Secretary shall publish in the Federal 
Register the fee revenues and fees resulting 
from the adjustment and the supporting meth-
odologies. 
‘‘(B) Under no circumstances shall the ad-
justment result in fee revenues for a fiscal year 
that are less than the fee revenues for the fiscal 
year established under subsection (b)(1), as ad-
justed for inflation under paragraph (1). Any 
adjustment for changes in inspections and re-
lated activities described in subsection (a) made 
in setting fees and revenue amounts for fiscal 
year 2011 or any subsequent year may not re-
sult in the total workload adjustment being 
more than 2 percentage points higher than it 
would have been in the absence of the adjust-
ment for changes in inspections and related ac-
tivities. 
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‘‘(C) The Secretary shall contract with an 
independent accounting firm to study the ad-
justment for changes in inspections and related 
activities described in subsection (a) applied in 
setting fees and revenue amounts for fiscal year 
2011 and to make recommendations, if war-
ranted, for future changes in the methodology 
for calculating the adjustment. After review of 
the recommendations, the Secretary shall, if 
warranted, make appropriate changes to the 
methodology, and the changes shall be effective 
for each of fiscal years 2012 through 2014. The 
Secretary shall not make any adjustment for 
changes in inspections and related activities de-
scribed in subsection (a) for any fiscal year 
after 2011 unless such study has been com-
pleted. 
‘‘(3) RENT AND RENT-RELATED COST ADJUST-
MENT.—For fiscal year 2012 and each subsequent 
fiscal year, the Secretary shall, before making ad-
justments under paragraphs (1) and (2), decrease 
the fee revenue amount established under subsection 
(b)(1) if actual costs paid for rent and rent-related 
expenses for the preceding fiscal year are less than 
estimates made for such year in fiscal year 2008. 
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Any reduction made under this paragraph shall not 
exceed the amount by which such costs fall below the 
estimates made in fiscal year 2008 for such fiscal 
year, and shall not exceed $11,721,000 for any fiscal 
year. 
‘‘(4) FINAL
YEAR
ADJUSTMENT.—For fiscal 
year 2014, the Secretary may, in addition to adjust-
ments under paragraphs (1), (2), (3), and (5), fur-
ther increase the fee revenues and fees established in 
subsection (b) if such an adjustment is necessary to 
provide for not more than 3 months of operating re-
serves of carryover user fees for inspections de-
scribed in subsection (a) for the first 3 months of 
fiscal year 2015. If such an adjustment is necessary, 
the rationale for the amount of the increase shall be 
contained in the annual notice establishing fee reve-
nues and fees for fiscal year 2014. If the Secretary 
has carryover balances for such inspections in excess 
of 3 months of such operating reserves, the adjust-
ment under this paragraph shall not be made. 
‘‘(5) COST ESTIMATE ADJUSTMENT.—For fiscal 
year 2011 and subsequent fiscal years, the Secretary 
by notice, published in the Federal Register, shall— 
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‘‘(A) provide an estimate of the amount of 
the total increases described in subsection (a) 
for such fiscal year; and 
‘‘(B) after making adjustments under 
paragraphs (1), (2), and (3), adjust the reve-
nues established under subsection (b)(1) to be 
equal to such amount. 
‘‘(6) LIMIT.—The total amount of fees charged, 
as adjusted under this subsection, for a fiscal year 
may not exceed the total increases described in sub-
section (a) for such fiscal year. 
‘‘(d) WAIVERS.—The Secretary shall waive the fee 
under this section with respect to any facility that is a 
small business, as defined by the Secretary. 
‘‘(e) 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 the fiscal year 2010 (excluding the 
amount of fees appropriated for such fiscal year) 
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multiplied by the adjustment factor applicable to the 
fiscal year involved. 
‘‘(2) AUTHORITY.—If the Secretary does not 
assess fees under subsection (a) during any portion 
of a fiscal year because of paragraph (1) and if at 
a later date in such fiscal year the Secretary may as-
sess such fees, the Secretary may assess and collect 
such fees, without any modification in the rate, for 
registration under section 415 at any time in such 
fiscal year. 
‘‘(f) 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
APPROPRIATION 
ACTS.— 
‘‘(A) IN
GENERAL.—The fees authorized 
by this section— 
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‘‘(i) shall be retained in each fiscal 
year in an amount not to exceed the 
amount specified in appropriation Acts, or 
otherwise made available for obligation, for 
such fiscal year; and 
‘‘(ii) shall only be collected and avail-
able to defray increases in the costs of in-
specting establishments registered under 
section 415 and related activities to ensure 
compliance by such establishments with the 
requirements of this Act relating to food 
(including increases in such costs for an 
additional number of full-time equivalent 
positions in the Department of Health and 
Human Services to be engaged in such in-
spections and for management of informa-
tion, and the acquisition, maintenance, and 
repair of information technology resources) 
over such costs, excluding costs paid from 
fees collected under this section, for fiscal 
year 2009 multiplied by the adjustment 
factor. 
‘‘(B) COMPLIANCE.—The Secretary shall 
be considered to have met the requirements of 
subparagraph (A)(ii) in any fiscal year if the 
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costs funded by appropriations and allocated for 
inspections described in subsection (a)— 
‘‘(i) are not more than 3 percent 
below the level specified in subparagraph 
(A)(ii); or 
‘‘(ii)(I) are more than 3 percent below 
the level specified in subparagraph (A)(ii), 
and fees assessed for the fiscal year fol-
lowing the subsequent fiscal year are de-
creased by the amount in excess of 3 per-
cent by which such costs fell below the 
level specified in such subparagraph; and 
‘‘(II) such costs are not more than 5 
percent below the level specified in such 
subparagraph. 
‘‘(3) AUTHORIZATION
OF
APPROPRIATIONS.— 
For each of the fiscal years 2010 through 2014, 
there is authorized to be appropriated for fees under 
this section an amount equal to the total revenue 
amount determined under subsection (b)(1) for the 
fiscal year, as adjusted or otherwise affected under 
subsection (c) and paragraph (4) of this subsection. 
‘‘(4) OFFSET.—If the sum of the cumulative 
amount of fees collected under this section for the 
fiscal years 2010 through 2013 and the amount of 
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fees estimated to be collected under this section for 
fiscal year 2014 exceeds the cumulative amount ap-
propriated under paragraph (3) for the fiscal years 
2010 through 2013, the excess shall be credited to 
the appropriation account of the Food and Drug Ad-
ministration as provided in paragraph (1), and shall 
be subtracted from the amount of fees that would 
otherwise be authorized to be collected under this 
section for fiscal year 2014. 
‘‘(g) 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. 
‘‘(h) CONSTRUCTION.—This section may not be con-
strued to require that the number of full-time equivalent 
positions in the Department of Health and Human Serv-
ices, for officers, employers, and advisory committees not 
engaged in inspections described in subsection (a), be re-
duced to offset the number of officers, employees, and ad-
visory committees so engaged. 
‘‘(i) ANNUAL FISCAL REPORTS.—Beginning with fis-
cal year 2011, not later than 120 days after the end of 
each fiscal year for which fees are collected under this sec-
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tion, the Secretary shall prepare and submit to the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives 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. 
‘‘(j) DEFINITION.—In this section, the term ‘adjust-
ment 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.’’. 
(c) CONTENTS OF REGISTRATION.—Paragraph (2) of 
section 415(a) (21 U.S.C. 350d(a)) is amended by striking 
‘‘containing information’’ and all that follows and insert-
ing the following: ‘‘containing information that identifies 
the following: 
‘‘(A) The name, address, and emergency 
contact information of each facility engaged in 
manufacturing, processing, packing, or holding 
food for consumption in the United States that 
the registrant operates. 
‘‘(B) The primary purpose and business 
activity of each such facility, including the dates 
of operation if the facility is seasonal. 
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‘‘(C) The general food category (as listed 
under section 170.3(n) of title 21, Code of Fed-
eral Regulations, or as the Secretary may other-
wise designate for purposes of evaluating poten-
tial threats to food protection) of any food man-
ufactured, processed, packed, or held at each 
such facility. 
‘‘(D) All trade names under which each 
such facility conducts business related to food. 
‘‘(E) The name, address, and 24-hour 
emergency contact information of the United 
States distribution agent for each such facility, 
which agent shall maintain information on the 
wholesale and retail distribution of food. 
The registrant shall notify the Secretary of any 
change in the products, function, or legal status of 
each such facility (including cessation of business ac-
tivities) not later than 30 days after the date of such 
change.’’. 
(d) SUSPENSION AUTHORITY.—Section 415(a) (21 
U.S.C. 350d(a)), as amended by subsection (c), 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-
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istered under this section, including the facility 
of an importer— 
‘‘(i) for violation of this Act that could 
result in serious adverse health con-
sequences or death to humans or animals; 
or 
‘‘(ii) if the facility, or an employee of 
the facility, delays or limits an inspection, 
or refuses to permit entry or inspection, by 
the Secretary under this Act. 
‘‘(B) NOTICE
AND
OPPORTUNITY
FOR 
HEARING.—Before suspending the registration 
of a facility under this paragraph, the Secretary 
shall provide notice to a registrant of an intent 
to suspend the registration and provide the reg-
istrant with an opportunity for an informal 
hearing. The Secretary may issue a written 
order of suspension following the hearing, if the 
Secretary finds that a violation described in 
subparagraph (A) has occurred. 
‘‘(C) 
REINSTATEMENT.—A 
registration 
that is suspended under this section may be re-
instated pursuant to criteria published by the 
Secretary in the Federal Register and on a pub-
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lic website of the Food and Drug Administra-
tion. 
‘‘(D) APPEAL.—Any registrant whose reg-
istration is suspended under this section may 
appeal that action in any appropriate district 
court of the United States.’’. 
(e) EFFECTIVE DATES.— 
(1) FEES.— 
(A) EFFECTIVE DATE.—The Secretary of 
Health and Human Services shall first impose 
the fee established under section 741 of the 
Federal Food, Drug, and Cosmetic Act, as 
added by subsection (b)(2), for fiscal years be-
ginning with fiscal year 2010. 
(B) SUNSET
DATE.—Section 741 of the 
Federal Food, Drug, and Cosmetic Act, as 
added by subsection (b)(2), does not authorize 
the assessment or collection of a fee for reg-
istration under section 415 of such Act (21 
U.S.C. 360) occurring after fiscal year 2014. 
(2) MODIFICATION OF REGISTRATION FORM.— 
Not later than 30 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 
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Cosmetic Act (21 U.S.C. 350d) to comply with the 
amendments made by subsection (c). 
(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 60 days after the 
date of the enactment of this Act. 
SEC. 102. HAZARD ANALYSIS, RISK-BASED PREVENTIVE 
CONTROLS, AND FOOD SAFETY PLAN. 
(a) PROHIBITED ACT.—Section 301 (21 U.S.C. 331) 
is amended by adding at the end the following: 
‘‘(oo) The operation of a facility that manufactures, 
processes, packs, transports, or holds food for consump-
tion in the United States if the owner, operator, or agent 
in charge of such facility is not in compliance with sections 
418 and 418A.’’. 
(b) REQUIREMENTS.—Chapter IV (21 U.S.C. 341 et 
seq.) is amended by adding at the end the following: 
‘‘SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVEN-
TIVE CONTROLS. 
‘‘(a) IN GENERAL.—The owner, operator, or agent 
in charge of a facility shall, in accordance with this sec-
tion, evaluate the hazards that could affect food manufac-
tured, processed, packed, transported, or held by such fa-
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cility, identify and implement preventive controls to sig-
nificantly minimize, prevent, or eliminate the occurrence 
of such hazards, monitor the performance of such controls, 
and maintain records of such monitoring. 
‘‘(b) HAZARD ANALYSIS.—The owner, operator, or 
agent in charge of a facility shall identify and evaluate 
known or reasonably foreseeable hazards that may be as-
sociated with the facility, including— 
‘‘(1) biological, chemical, physical, and radio-
logical hazards, natural toxins, pesticides, drug resi-
dues, decomposition, parasites, allergens, and unap-
proved food and color additives; 
‘‘(2) hazards that occur naturally, may be unin-
tentionally introduced, or may be intentionally intro-
duced, including by acts of terrorism; and 
‘‘(3) relevant hazards identified under section 
419. 
‘‘(c) PREVENTIVE CONTROLS.— 
‘‘(1) IN
GENERAL.—The owner, operator, or 
agent in charge of a facility shall identify, imple-
ment, and validate preventive controls, including at 
critical control points, if any, to significantly mini-
mize, prevent, or eliminate hazards identified in the 
hazard analysis conducted under subsection (b). 
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‘‘(2) SPECIFIC
PRODUCT
TYPES.—The Sec-
retary may establish by regulation or guidance addi-
tional preventive controls under this section for spe-
cific product types to prevent intentional or uninten-
tional contamination throughout the supply chain. 
‘‘(d) MONITORING OF EFFECTIVENESS.—The owner, 
operator, or agent in charge of a facility shall monitor the 
effectiveness of the preventive controls implemented under 
subsection (c). 
‘‘(e) CORRECTIVE ACTIONS.—The owner, operator, 
or agent in charge of a facility shall establish procedures 
that the facility will implement if the preventive controls 
implemented under subsection (c) are found to be ineffec-
tive through monitoring under subsection (d). 
‘‘(f) VERIFICATION.—The owner, operator, or agent 
in charge of a facility shall verify that— 
‘‘(1) the preventive controls implemented under 
subsection (c) have been validated as adequate to 
control the hazards identified under subsection (b); 
‘‘(2) the owner, operator, or agent is conducting 
monitoring in accordance with subsection (d); and 
‘‘(3) the owner, operator, or agent is taking ef-
fective corrective actions under subsection (e). 
‘‘(g) RECORD KEEPING.—The owner, operator, or 
agent in charge of a facility shall maintain, for not less 
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than 2 years, records documenting the monitoring and 
verification of the effectiveness of the actions described in 
subsections (a) through (f). 
‘‘(h) REQUIREMENT TO REANALYZE.—Each owner, 
operator, or agent in charge of a facility shall— 
‘‘(1) conduct a reanalysis under subsection 
(b)— 
‘‘(A) whenever there is a reasonable poten-
tial for a new hazard or a significant increase 
in a previously identified hazard; 
‘‘(B) not less frequently than once every 2 
years; and 
‘‘(C) if the Secretary determines it to be 
appropriate for the protection of the public 
health; and 
‘‘(2) revise the preventive controls under sub-
section (c) to significantly minimize, prevent, or 
eliminate such hazard or document the basis for the 
conclusion that no such revision is needed. 
‘‘(i) DEFINITIONS.—For purposes of this section: 
‘‘(1) CRITICAL
CONTROL
POINT.—The term 
‘critical control point’ means a point, step, or proce-
dure in a food process at which control can be ap-
plied and is essential to prevent or eliminate a food 
safety hazard or reduce it to an acceptable level. 
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‘‘(2) FACILITY.—The term ‘facility’ means a 
domestic facility or a foreign facility that is required 
to register under section 415. 
‘‘(3) 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 have em-
ployed to significantly minimize, prevent, or elimi-
nate the hazards identified under the hazard anal-
ysis conducted under subsection (a) and that are 
consistent with the current scientific understanding 
of safe food manufacturing, processing, packing, 
transporting, or holding at the time of the analysis. 
Those procedures, practices, and processes may in-
clude the following: 
‘‘(A) Sanitation procedures for food con-
tact surfaces and utensils and food-contact sur-
faces of equipment. 
‘‘(B) Supervisor, manager, and employee 
hygiene training. 
‘‘(C) An environmental monitoring pro-
gram to verify the effectiveness of pathogen 
controls. 
‘‘(D) An allergen control program. 
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‘‘(E) A recall contingency plan. 
‘‘(F) Good manufacturing practices. 
‘‘(G) Supplier verification activities. 
‘‘SEC. 418A. FOOD SAFETY PLAN. 
‘‘(a) IMPLEMENTATION OF FOOD SAFETY PLAN.— 
‘‘(1) IN GENERAL.—Before a facility (as de-
fined in section 418(i)) introduces or delivers for in-
troduction into interstate commerce any shipment of 
food, the owner, operator, or agent in charge of the 
facility shall develop and implement a written food 
safety plan (in this section referred to as a ‘food 
safety plan’). 
‘‘(2) CONTENTS.—The food safety plan shall in-
clude each of the following elements: 
‘‘(A) The hazard analysis conducted under 
section 418. 
‘‘(B) A description of the preventive con-
trols being implemented under section 418(c), 
including any those for specific product types 
under section 418(c)(2). 
‘‘(C) Validation that such preventive con-
trols are effective to reduce, control, or elimi-
nate such hazard. 
‘‘(D) A description of monitoring of such 
preventive controls being implemented, includ-
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ing sampling and testing relating to the control 
of hazards where appropriate to verify that the 
controls are effective. 
‘‘(E) A description of the record keeping 
being conducted, including evidence of correc-
tive actions, sampling and testing records, mon-
itoring and verification records, and validation 
records. 
‘‘(F) A description of established proce-
dures for the recall of articles of food, whether 
voluntarily or when required under section 422. 
‘‘(G) A description of established proce-
dures for the trace back of articles of food, 
whether voluntarily or when required under sec-
tion 403(g). 
‘‘(H) A description of established proce-
dures to ensure a safe and secure supply chain 
for the ingredients or components used in mak-
ing the food produced, processed, packed, trans-
ported, or held by such facility. 
‘‘(I) A description of established proce-
dures to implement the science-based perform-
ance standards issued under section 419. 
‘‘(b) INSPECTION OF FOOD SAFETY PLAN IN COURSE 
OF FACILITY INSPECTION.—In the course of a facility in-
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spection under section 704, the Secretary shall conduct 
a review of the food safety plan to ensure the plan meets 
relevant requirements of section 418, this section, and sec-
tion 419 and is adequate to protect the public health.’’. 
(c) GUIDANCE OR REGULATIONS.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this subsection as 
the ‘‘Secretary’’) shall issue guidance or promulgate 
regulations to establish science-based minimum 
standards for conducting a hazard analysis, docu-
menting hazards, implementing preventive controls, 
and documenting the implementation of the preven-
tive controls under sections 418 and 418A of the 
Federal Food, Drug, and Cosmetic Act (as added by 
subsection (b)). 
(2) CONSIDERATION.—In issuing guidance or 
promulgating regulations under this section, the Sec-
retary shall consider the capacity of small busi-
nesses. 
(d) NO EFFECT ON HACCP AUTHORITIES.—Noth-
ing in the amendments made by this section limits the au-
thority 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.) to revise, issue, 
or enforce product and category-specific regulations, such 
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as the Seafood Hazard Analysis Critical Controls Points 
Program, the Juice Hazard Analysis Critical Control Pro-
gram, and the Thermally Processed Low-Acid Foods 
Packaged in Hermetically Sealed Containers standards. 
(e) EFFECTIVE DATE.— 
(1) GENERAL RULE.—The amendments made 
by this section shall take effect 18 months after the 
date of the enactment of this Act. 
(2) EXCEPTIONS.—Notwithstanding paragraph 
(1)— 
(A) the amendments made by this section 
shall apply to a small business (as defined by 
the Secretary) after the date that is 2 years 
after the date of the enactment of this Act; and 
(B) the amendments made by this section 
shall apply to a very small business (as defined 
by the Secretary) after the date that is 3 years 
after the date of the enactment of this Act. 
SEC. 103. PERFORMANCE STANDARDS. 
Chapter IV (21 U.S.C. 341 et seq.), as amended by 
section 102, is further amended by adding at the end the 
following: 
‘‘SEC. 419. PERFORMANCE STANDARDS. 
‘‘The Secretary shall, not less frequently than every 
2 years, review and evaluate epidemiological data and 
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other appropriate sources of information, including re-
search under section 113 of the Food and Drug Adminis-
tration Globalization Act of 2009, to identify the most sig-
nificant food-borne contaminants and the most significant 
resulting hazards, and shall issue, through guidance or by 
regulation, science-based performance standards (which 
may include action levels) to significantly minimize, pre-
vent, or eliminate the occurrence of such hazards. Such 
standards shall be applicable to products and product 
classes and shall not be specific to an individual facility.’’. 
SEC. 104. SAFETY STANDARDS FOR FRESH PRODUCE. 
(a) PROHIBITED ACT.—Section 301 (21 U.S.C. 331), 
as amended by sections 102 and 103, is amended by add-
ing at the end the following: 
‘‘(pp) The production or harvesting of produce not 
in accordance with minimum standards as provided by 
regulation under section 419A(a) or a variance issued 
under section 419A(e).’’. 
(b) STANDARDS.—Chapter IV (21 U.S.C. 341 et 
seq.), as amended by sections 102 and 103, is amended 
by adding at the end the following: 
‘‘SEC. 419A. STANDARDS FOR PRODUCE SAFETY. 
‘‘(a) STANDARDS.—The Secretary shall establish by 
regulation science-based minimum standards for the safe 
production and harvesting of those types of fruits and 
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vegetables that are raw agricultural commodities for which 
the Secretary has determined that such standards mini-
mize the risk of serious adverse health consequences or 
death. 
‘‘(b) CONTENTS.—The regulations under subsection 
(a)— 
‘‘(1) shall 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 fruits and 
vegetables that are raw agricultural commod-
ities; and 
‘‘(B) to provide reasonable assurances that 
the produce is not adulterated under section 
402; 
‘‘(2) shall include, with respect to growing, har-
vesting, packing, sorting, and storage operations, 
minimum standards for safety; 
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‘‘(3) shall include standards addressing manure 
use, water quality, employee hygiene, sanitation and 
animal control, temperature controls, and nutrients; 
‘‘(4) may include standards for such other ele-
ments as the Secretary determines necessary to 
carry out subsection (a); 
‘‘(5) shall provide a reasonable period of time 
for compliance, taking into account the needs of 
small businesses for additional time to comply; and 
‘‘(6) shall provide for coordination of education 
and enforcement activities by State and local offi-
cials, as designated by the Governors of the respec-
tive States. 
‘‘(c) PRIORITIZATION.—The Secretary shall prioritize 
the implementation of the regulations under subsection (a) 
for specific fruits and vegetables that are raw agricultural 
commodities and have been associated with food-borne ill-
ness outbreaks. 
‘‘(d) ENFORCEMENT.—The Secretary may coordinate 
with the Secretary of Agriculture and shall 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) GUIDANCE; RULEMAKING.— 
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(1) GUIDANCE.—Not later than 1 year after 
the date of enactment of this Act, the Secretary 
shall publish, after consultation with the Secretary 
of Agriculture and representatives of State depart-
ments of agriculture, updated good agricultural 
practices and guidance for the safe production and 
harvesting of specific types of fresh produce. 
(2) PROPOSED RULEMAKING.— 
(A) IN GENERAL.—Not later than 1 year 
after the date of the enactment of this Act, the 
Secretary, in consultation with the Secretary of 
Agriculture and representatives of State depart-
ments of agriculture, shall publish a notice of 
proposed rulemaking under section 419A of the 
Federal Food, Drug, and Cosmetic Act, as 
added by subsection (b). 
(B) PUBLIC INPUT.—During the comment 
period on the notice of proposed rulemaking 
under subparagraph (A), the Secretary shall 
conduct not less than 3 public meetings in di-
verse geographical areas of the United States to 
provide persons in different regions an oppor-
tunity to comment. 
(3) FINAL REGULATION.—Not later than 1 year 
after the close of the comment period for the pro-
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posed rulemaking under paragraph (2), the Sec-
retary shall adopt a final regulation under section 
419A of the Federal Food, Drug, and Cosmetic Act, 
as added by subsection (b). 
(d) NO EFFECT ON HACCP AUTHORITIES.—Noth-
ing in the amendments made by this section limits the au-
thority 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.) 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 Pro-
gram, and the Thermally Processed Low-Acid Foods 
Packaged in Hermetically Sealed Containers standards. 
SEC. 105. RISK-BASED INSPECTION. 
(a) RISK-BASED INSPECTION SCHEDULE.— 
(1) 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 by one or more officers duly designated 
by the Secretary at a frequency determined pursuant to 
a risk-based schedule. 
‘‘(2) The Secretary shall establish such risk-based 
schedule not later than 18 months after the date of the 
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enactment of this subsection and may subsequently revise 
such schedule in accordance with this section. 
‘‘(3) Such risk-based schedule shall provide for a fre-
quency of inspections commensurate with the risk pre-
sented by the facility, but in no case shall inspections of 
a facility occur less than once every 4 years beginning on 
the date of the facility’s initial registration pursuant to 
section 415. 
‘‘(4) In determining the appropriate frequency of in-
spection, the Secretary shall consider— 
‘‘(A) the type of food manufactured, processed, 
packed, or held at the facility; 
‘‘(B) the compliance history of the facility; 
‘‘(C) whether the facility is certified by a certi-
fying agent accredited pursuant to section 420(a); 
and 
‘‘(D) such other factors as the Secretary deter-
mines by guidance to be relevant to assessing the 
risk presented by the facility.’’. 
(2) FACILITIES
ALREADY
REGISTERED.—In 
section 704(h)(3) of the Federal Food, Drug, and 
Cosmetic Act, as added by paragraph (1), the term 
‘‘initial registration pursuant to section 415’’ means, 
with respect to a facility that is registered pursuant 
to section 415 of such Act as of the date of the en-
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actment of this Act, the first annual registration of 
the facility pursuant to such section 415 that occurs 
on or after such date of enactment. 
(3) REPORTS ON RISK-BASED INSPECTIONS OF 
FOOD FACILITIES.— 
(A) INITIAL REPORT.—Not later than 18 
months after the date of the enactment of this 
Act, the Secretary of Health and Human Serv-
ices shall submit a report to the Committee on 
Energy and Commerce of the House of Rep-
resentatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate 
describing the risk-based inspection schedule es-
tablished under section 704(h)(2) of the Fed-
eral Food, Drug, and Cosmetic Act, as added 
by paragraph (1). Such report shall include a 
description of the frequency of inspections for 
different classes of risk, the number of facilities 
in each class, and an estimate of the projected 
5-year costs of implementing such inspection 
schedule. 
(B) 
SUBSEQUENT
REPORTS.—Annually 
after the submission of the report required by 
subparagraph (A), the Secretary shall submit a 
report to the Congress on— 
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(i) the number of foreign and domes-
tic facilities inspected under the risk-based 
inspection schedule established under sec-
tion 704(h)(2) of the Federal Food, Drug, 
and Cosmetic Act, as added by paragraph 
(1), in the preceding 12 months; and 
(ii) the costs of implementing the risk- 
based inspection schedule for the preceding 
12 months. 
(b) FOOD OFFERED FOR IMPORT.—The third sen-
tence of subsection (a) of section 801 (21 U.S.C. 381) is 
amended by inserting ‘‘or (4) such article is food that has 
been processed, packed, or held at a facility that is in vio-
lation of section 301(f) (prohibiting the delay or limitation 
of an inspection, or the refusal to permit entry or inspec-
tion, under section 704),’’ before ‘‘then such article shall 
be refused admission’’. 
SEC. 106. ACCESS TO RECORDS. 
(a) RECORDS
INSPECTION.—Section 414(a) (21 
U.S.C. 350c) is amended— 
(1) by striking ‘‘If the Secretary has a reason-
able belief that an article of food is adulterated and 
presents a threat of serious adverse health con-
sequences or death to humans or animals, each’’ and 
inserting ‘‘Each’’; 
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(2) by striking the term ‘‘such article’’ the first 
place such term appears and inserting ‘‘an article of 
food’’; 
(3) by striking ‘‘and a written notice to such 
person’’; and 
(4) by striking ‘‘and presents a threat of seri-
ous adverse health consequences or death to humans 
or animals’’ and inserting ‘‘, misbranded, or other-
wise in violation of this Act’’; and 
(b) CONFORMING AMENDMENT.—Section 704(a)(1) 
(21 U.S.C. 374(a)(1)) is amended by striking ‘‘when the 
Secretary has a reasonable belief that an article of food 
is adulterated and presents a threat of serious adverse 
health consequences or death to humans or animals’’ and 
inserting ‘‘bearing on whether such food is adulterated, 
misbranded, or otherwise in violation of this Act’’. 
SEC. 107. TRACEABILITY OF FOOD. 
(a) FARM AND RESTAURANT RECORDS.— 
(1) INSPECTION.—Section 414(a) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
350c(a)), as amended by section 106, is amended by 
striking ‘‘(excluding farms and restaurants)’’. 
(2) 
MAINTENANCE
OF
RECORDS.—Section 
414(b) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 350c(b)), as amended by section 106, is 
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amended by striking ‘‘(excluding farms and res-
taurants)’’. 
(b) STANDARDIZED ELECTRONIC FORMAT.—Section 
414 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 350c(a)), as amended by section 106 and sub-
section (a), is amended— 
(1) in subsection (a), by striking ‘‘in any for-
mat (including paper and electronic formats) and’’; 
and 
(2) in subsection (b), by adding at the end the 
following: ‘‘The Secretary shall require such persons 
to maintain such records in a standardized electronic 
format.’’. 
(c) IDENTIFICATION OF SOURCE OF RAW AGRICUL-
TURAL PRODUCTS.—Section 403 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 343) is amended by 
adding at the end the following: 
‘‘(z) If it is a raw agricultural product, unless each 
commercial shipment of the product contains information 
enabling the Secretary to identify— 
‘‘(1) the grower of the product; 
‘‘(2) the lot on which the product was produced; 
‘‘(3) the harvesting and packing dates of the 
product; and 
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‘‘(4) any other information determined appro-
priate by the Secretary to facilitate identification of 
the source of raw agricultural products.’’. 
(d) STUDY.—Not later than 2 years after the date 
of the enactment of this Act, the Commissioner of Food 
and Drugs shall— 
(1) complete a study on the effectiveness of 
technologies for determining the source of raw agri-
cultural products; and 
(2) submit a report to the Congress on the re-
sults of such study. 
SEC. 108. REINSPECTION FEE APPLICABLE TO FACILITIES. 
(a) IN GENERAL.—Part 5 of subchapter C of chapter 
VII (21 U.S.C. 371 et seq.), as added by section 
101(b)(2), is further amended by adding at the end the 
following: 
‘‘SEC. 741A. REINSPECTION FEE APPLICABLE TO FACILI-
TIES. 
‘‘(a) IN GENERAL.—The Secretary shall assess and 
collect fees from each facility (as defined in section 
415(b)) that— 
‘‘(1) during such fiscal year, commits a viola-
tion of any requirement of this Act relating to food, 
including any such requirement relating to good 
manufacturing practices; and 
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‘‘(2) because of such violation, undergoes addi-
tional inspection by the Food and Drug Administra-
tion. 
‘‘(b) AMOUNT OF FEES.—The Secretary shall set the 
amount of the fees under this section to fully defray the 
costs of conducting the additional inspections referred to 
in subsection (a)(2). 
‘‘(c) USE OF FEES.—The Secretary shall make all 
of the fees collected pursuant to this section available sole-
ly to pay for the costs of additional inspections referred 
to in subsection (a)(2).’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply to additional inspections occur-
ring after the date of the enactment of this Act. 
SEC. 109. CERTIFICATION OF FOOD FACILITIES. 
(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 420(b)(5) (requiring a certification to accom-
pany 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) ACCREDITATION OF CERTIFYING AGENTS; CER-
TIFICATION OF LABORATORIES AND ACCREDITATION OF 
LABORATORY CERTIFYING AGENTS.—Chapter IV (21 
U.S.C. 341 et seq.), as amended by sections 102(b), 103, 
and 104, is amended by adding at the end the following: 
‘‘SEC. 420. ACCREDITATION OF CERTIFYING AGENTS. 
‘‘(a) ACCREDITATION AS CERTIFYING AGENT.— 
‘‘(1) IN GENERAL.—Beginning not later than 2 
years after the date of the enactment of this section, 
the Secretary shall establish and implement an ac-
creditation system under which a foreign govern-
ment, a State or regional food authority, a foreign 
or domestic cooperative that aggregates the products 
of growers or processors, and any other third party 
that the Secretary determines appropriate, may re-
quest to be accredited as a certifying agent to certify 
facilities as meeting the applicable requirements of 
this Act. 
‘‘(2) 
QUALIFICATIONS
OF
CERTIFYING 
AGENTS.—Prior to accrediting an third party as a 
certifying agent under paragraph (1), the Secretary 
shall perform such reviews and audits of the training 
and qualifications of auditors used by the third 
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party, and conduct such reviews of internal systems 
and such other investigation of the third party, as 
the Secretary deems necessary to determine whether 
the third party— 
‘‘(A) meets the requirements of this sec-
tion; and 
‘‘(B) is qualified to evaluate the compli-
ance of a facility with the applicable require-
ments of this Act. 
‘‘(3) LIMITATION
OF
ACCREDITATION.—The 
Secretary may limit the accreditation under para-
graph (1) of a certifying agent to the certification of 
facilities that produce, manufacture, process, or hold 
only specified food products (or categories of food 
products). 
‘‘(4) PERFORMANCE OF AUDITS AND RENEWAL 
OF ACCREDITATION.—The Secretary shall audit the 
performance of certifying agents on a periodic basis, 
but not less than every 4 years, for the purpose of 
renewing the accreditation of such agents. 
‘‘(5) WITHDRAWAL
OF
ACCREDITATION.—The 
Secretary— 
‘‘(A) may withdraw accreditation under 
paragraph (1) from a certifying agent if— 
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‘‘(i) a facility certified by the agent is 
linked to an outbreak of human or animal 
illness; or 
‘‘(ii) the Secretary finds that the 
agent no longer meets the requirements for 
accreditation; and 
‘‘(B) shall withdraw accreditation under 
paragraph (1) from a certifying agent if the 
Secretary finds that the certifying agent has re-
fused to allow the Secretary to conduct such 
audits and investigations as may be necessary 
to ensure continued compliance with the re-
quirements of this section. 
‘‘(6) PUBLICATION
OF
LIST
OF
CERTIFYING 
AGENTS.—The Secretary shall publish and maintain 
on the website of the Food and Drug Administration 
a current list of certifying agents accredited under 
this section, including— 
‘‘(A) each such agent’s name and location; 
and 
‘‘(B) any other information deemed nec-
essary by the Secretary. 
‘‘(b) ADDITIONAL REQUIREMENTS APPLICABLE TO 
CERTIFYING AGENTS.—As conditions of accreditation 
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under subsection (a), a certifying agent shall agree to the 
following: 
‘‘(1) 
AUDIT
REQUIREMENTS.—A 
certifying 
agent shall not certify a facility unless the certifying 
agent has— 
‘‘(A) conducted an on-site audit of the fa-
cility, which shall be unannounced for a domes-
tic facility; 
‘‘(B) reviewed the facility’s food safety 
plan under section 418A to ensure the plan 
meets applicable requirements of this Act and is 
adequate to protect the public health; 
‘‘(C) prepared an audit report in a form 
and manner designated by the Secretary; and 
‘‘(D) conducted any other review, analysis, 
or testing determined by the Secretary to be ap-
propriate for determining such facility’s compli-
ance with the applicable requirements of this 
Act. 
‘‘(2) ACCESS TO REPORTS AND RECORDS.—A 
certifying agent shall provide to the Secretary, upon 
request— 
‘‘(A) a copy of any audit report prepared 
under paragraph (1)(C); 
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‘‘(B) any records relating to corrective ac-
tions planned or taken by the audited facility; 
and 
‘‘(C) any other records related to— 
‘‘(i) the certification or decertification 
of a facility; 
‘‘(ii) compliance of a facility with the 
requirements of this Act; or 
‘‘(iii) the accreditation of the certi-
fying agent. 
‘‘(3) CONFLICTS OF INTEREST.— 
‘‘(A) IN
GENERAL.—A certifying agent 
shall— 
‘‘(i) not have an ownership, manage-
ment, or other financial interest in any fa-
cility to be certified by the certifying agent 
or in such facility’s suppliers or vendors; 
‘‘(ii) 
have 
procedures 
to 
ensure 
against the use, in carrying out audits of 
a facility under this section, of any officer 
or employee who has a financial conflict of 
interest regarding such facility; and 
‘‘(iii) have written conflict of interest 
policies that include prompt disclosure to 
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the Secretary of all conflicts or potential 
conflicts of interest. 
‘‘(B) REGULATIONS.—Not later than 18 
months after the date of the enactment of this 
section, the Secretary shall promulgate regula-
tions to implement the requirements of sub-
paragraph (A). Such regulations shall include a 
structure, including timing and public disclo-
sure, for fees paid by facilities to certifying 
agents. 
‘‘(4) DECERTIFICATION OF FACILITIES.—A cer-
tifying agent shall decertify a facility if the certi-
fying agent, after providing a reasonable opportunity 
for corrective action, finds that the facility no longer 
meets the applicable requirements of this Act. 
‘‘(5) REQUIRED CERTIFICATION OF IMPORTS.— 
A certifying agent shall issue a written and elec-
tronic certification to accompany each shipment of-
fered for import into the United States containing 
food that was manufactured, processed, packed, or 
held by a facility certified by the agent, subject to 
requirements set forth by the Secretary. 
‘‘(6) RISKS TO PUBLIC HEALTH.—If, at any 
time during an audit, an auditor of a certifying 
agent finds a condition at a facility that could cause 
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or contribute to illness or injury to an individual 
consuming an article of food manufactured, proc-
essed, packed, or held by the facility, the certifying 
agent shall immediately notify the Secretary of the 
identity of the facility and such condition. 
‘‘(c) FALSE
OR MISLEADING STATEMENTS.—For 
purposes of section 301(q)(2), any statement or represen-
tation made by an employee or agent of a facility to an 
auditor of a certifying agent or a certifying agent is 
deemed to be a report required by or under this Act. 
‘‘(d) DEFINITIONS.—In this section: 
‘‘(1) The term ‘certifying agent’ means a third 
party accredited as a certifying agent pursuant to 
subsection (a)(1). 
‘‘(2) The term ‘facility’ means a facility re-
quired to be registered under section 415. 
‘‘SEC. 421. CERTIFICATION OF LABORATORIES; ACCREDITA-
TION OF LABORATORY CERTIFYING AGENTS. 
‘‘(a) IN GENERAL.—Not later than 2 years after the 
date of the enactment of this section, the Secretary shall 
establish a program for the certification of laboratories for 
the purpose of conducting sampling and testing of food 
to ensure compliance with the requirements of this Act. 
‘‘(b) STANDARDS.—Not later than 18 months after 
the date of the enactment of this section, the Secretary 
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shall develop standards to certify laboratories under this 
section. Such standards shall include— 
‘‘(1) standards for sampling and analytical pro-
cedures; 
‘‘(2) training and qualification levels for indi-
viduals who conduct the analyses; 
‘‘(3) standards for internal quality systems; and 
‘‘(4) any other standards determined appro-
priate by the Secretary. 
‘‘(c) ACCREDITATION OF THIRD PARTIES AS LAB-
ORATORY CERTIFYING AGENTS.— 
‘‘(1) IN GENERAL.—The Secretary may estab-
lish an accreditation system under which third par-
ties, as determined appropriate by the Secretary, 
may request to be accredited as a laboratory certi-
fying agent to certify laboratories as meeting the ap-
plicable requirements of this Act. 
‘‘(2) APPLICATION OF REQUIREMENTS RELAT-
ING TO QUALIFICATIONS OF AGENTS, PERFORMANCE 
OF AUDITS AND RENEWAL OF ACCREDITATION, AND 
WITHDRAWAL OF ACCREDITATION.—The provisions 
of paragraphs (2), (4), and (5), other than para-
graph (5)(A)(i), of section 420(a) shall apply to the 
accreditation of laboratory certifying agents with re-
spect to laboratories in the same manner as such 
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provisions apply to the accreditation of certifying 
agents with respect to facilities. 
‘‘(3) APPLICATION
OF
ADDITIONAL
REQUIRE-
MENTS.—The provisions of paragraphs (1) (other 
than subparagraph (B) and other than the require-
ment under subparagraph (A) that an audit be un-
announced), (2), (3), and (4) of section 420(b) shall 
apply to laboratory certifying agents under this sub-
section with respect to laboratories in the same man-
ner as such provisions apply to the certifying agents 
with respect to facilities. 
‘‘(4) LABORATORY
CERTIFYING
AGENT
DE-
FINED.—In this section, the term ‘laboratory certi-
fying agent’ means a third party accredited as a lab-
oratory certifying agent under this subsection. 
‘‘(d) PUBLICATION OF LIST OF CERTIFYING AGENTS 
AND CERTIFIED LABORATORIES.—The provisions of para-
graph (6) of section 420(a) shall apply to third parties 
accredited as laboratory certifying agents under sub-
section (c) and to laboratories certified under subsection 
(a) in the same manner as such provisions apply to third 
parties accredited as certifying agents under such section. 
‘‘(e) FOOD
TESTING
BY
CERTIFIED
LABORA-
TORIES.— 
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‘‘(1) IN GENERAL.—Beginning 3 years after the 
date of the enactment of this section, testing of food 
described in paragraph (2) shall be conducted only 
by Federal laboratories or by laboratories certified 
under subsection (a). 
‘‘(2) TESTING OF FOOD COVERED.—The testing 
of food described in this paragraph is testing of 
food— 
‘‘(A) conducted in support of an admission 
of an article of food under section 801; 
‘‘(B) conducted in support of a reoffer of 
food previously denied admission under section 
402(h); 
‘‘(C) conducted under an import alert that 
requires successive consecutive tests; 
‘‘(D) conducted to show compliance with 
an order of the Secretary; 
‘‘(E) conducted in support of an appeal of 
an order of the Secretary; or 
‘‘(F) as otherwise required to be conducted 
by the Secretary, as the Secretary deems appro-
priate. 
‘‘(3) ACCESS TO TESTING RESULTS.—The re-
sults of any testing of food described in paragraph 
(2) by a laboratory certified under this section shall 
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be promptly transmitted by such laboratory in elec-
tronic format to the Secretary. 
‘‘(f) FALSE
OR MISLEADING STATEMENTS.—For 
purposes of section 301(q)(2), as amended by section 406, 
any statement or representation made by an employee or 
agent of a laboratory to a laboratory certifying agent is 
deemed to be a report required by or under this Act.’’. 
(c) FEES.—Part 5 of subchapter C of chapter VII, 
as added by section 101(b) and amended by section 
108(a), is amended by adding at the end the following: 
‘‘SEC. 741B. CERTIFYING AGENT FEE. 
‘‘(a) IN GENERAL.—The Secretary shall assess and 
collect a fee for the accreditation of an entity as a certi-
fying agent under section 420(a) for the purpose of de-
fraying the costs of implementing the system established 
for such accreditation. 
‘‘(b) AMOUNT OF FEE.—The amount of a fee under 
this section shall be as determined by the Secretary. 
‘‘SEC. 741C. LABORATORY CERTIFYING AGENT ACCREDITA-
TION FEE. 
‘‘The Secretary shall assess and collect an annual fee, 
specified by the Secretary, for accreditation of laboratory 
certifying agents under section 421 for the purpose of de-
fraying the costs of the accreditation activities under such 
section.’’. 
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SEC. 110. 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.—Beginning not later than 2 years 
after the date of the enactment of this section, the Sec-
retary shall establish by regulation and carry out a pro-
gram under which the Secretary expedites the movement 
of food through the importation process under this Act 
if each facility involved in the production, manufacture, 
processing, packaging, and holding of the food— 
‘‘(1) is certified by a certifying agent accredited 
pursuant to section 420(a)(1); and 
‘‘(2) has agreed to abide by, and has been de-
termined by the Secretary to be in compliance with, 
the food safety and security guidelines developed 
under subsection (b) with respect to such food. 
‘‘(b) GUIDELINES.— 
‘‘(1) DEVELOPMENT.—For purposes of the pro-
gram established under subsection (a), the Secretary 
shall develop safety and security guidelines applica-
ble to the importation of food. 
‘‘(2) FACTORS.—Such guidelines shall take into 
account the following factors: 
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‘‘(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 access controls for 
food and ingredients purchased by such person. 
‘‘(D) Vendor and supplier information. 
‘‘(E) Such other factors as the Secretary 
determines necessary.’’. 
Subtitle B—Intervention 
SEC. 111. PUBLIC HEALTH ASSESSMENT SYSTEM. 
(a) ACTIVE SURVEILLANCE SYSTEM.—The Secretary 
of Health and Human Services (in this subtitle referred 
to as the ‘‘Secretary’’), acting through the Centers for 
Disease Control and Prevention, shall establish and imple-
ment an active surveillance system for food, based on a 
representative proportion of the population of the United 
States, to assess more accurately the frequency and 
sources of human illness in the United States associated 
with the consumption of food. 
(b) SAMPLING SYSTEM.— 
(1) IN GENERAL.—The Secretary shall establish 
and implement a sampling system under which the 
Secretary takes and analyzes samples of food prod-
ucts— 
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(A) to assist the Secretary in carrying out 
this Act and the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 301 et seq.); and 
(B) to more accurately assess the nature, 
frequency of occurrence, and amounts of con-
taminants in food products. 
(2) REQUIREMENTS.—Such sampling system 
shall provide— 
(A) statistically valid monitoring, including 
market-basket studies, on the nature, frequency 
of occurrence, and amounts of contaminants in 
food products available to consumers; and 
(B) at the request of the Secretary, such 
other information, including analysis of moni-
toring and verification samples, as the Sec-
retary determines may be useful in assessing 
the occurrence of contaminants in food prod-
ucts. 
(3) GUIDELINES.—Within 12 months after the 
date of the enactment of this Act, the Secretary 
shall establish guidelines for the sampling system 
under this subsection. 
(c) ASSESSMENT OF HEALTH HAZARDS.—Through 
the surveillance system under subsection (a) and the sam-
pling system under subsection (b), the Secretary shall 
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rank food categories based on their hazard to human 
health and identify appropriate industry and regulatory 
approaches to minimize hazards in the food supply. Such 
analysis may include— 
(1) the safety of commercial harvesting and 
processing, as compared with the health hazards as-
sociated with food products that are harvested for 
recreational or subsistence purposes and prepared 
noncommercially; 
(2) the safety of food products that are domes-
tically harvested and processed, as compared with 
the health hazards associated with food products 
that are harvested or processed outside the United 
States; 
(3) contamination originating from handling 
practices that occur prior to or after sale of food 
products to consumers; and 
(4) use of comparative risk assessments. 
SEC. 112. 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— 
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(1) information to the public regarding Federal 
standards and good practice requirements and pro-
motion of public awareness, understanding, and ac-
ceptance of such standards and requirements; 
(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 
(3) incorporate State and local advisories into 
the national public education program required 
under subsection (a). 
SEC. 113. RESEARCH. 
(a) IN GENERAL.—The Secretary shall conduct re-
search to assist in the implementation of this Act, includ-
ing studies to— 
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(1) improve sanitation and food safety practices 
in the processing of food products; 
(2) develop improved techniques for the moni-
toring of food and inspection of food products; 
(3) develop efficient, rapid, and sensitive meth-
ods for determining and detecting the presence of 
contaminants in food products; 
(4) determine the sources of contamination of 
food and food products with contaminants; 
(5) develop consumption data with respect to 
food products; 
(6) draw upon research and educational pro-
grams that exist at the State and local level; 
(7) utilize the DNA matching system and other 
processes to identify and control pathogens; 
(8) address common and emerging zoonotic dis-
eases; 
(9) develop methods to reduce or destroy patho-
gens before, during, and after processing; 
(10) analyze the incidence of antibiotic resist-
ance as it pertains to the food supply and develop 
new methods to reduce the transfer of antibiotic re-
sistance to humans; and 
(11) conduct other research that supports the 
purposes of this Act. 
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(b) CONTRACT AUTHORITY.—The Secretary is au-
thorized to enter into contracts and agreements with any 
State, university, government agency, or other person to 
carry out this section. 
SEC. 114. NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED ARTI-
CLES OF FOOD. 
(a) PROHIBITED ACTS.—Section 301 (21 U.S.C. 
331), as amended by sections 102 and 104, is amended 
by adding at the end the following: 
‘‘(qq)(1) The failure to notify the Secretary in viola-
tion of section 422(a). 
‘‘(2) The failure to comply with— 
‘‘(A) an order issued under section 422(b) fol-
lowing any hearing requested under section 422(c); 
or 
‘‘(B) an amended order issued under section 
422(d)(1).’’. 
(b) NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF
ADULTERATED
OR
MISBRANDED
ARTICLES
OF 
FOOD.—Chapter IV (21 U.S.C. 341 et seq.), as amended 
by sections 102(b), 104, and 108(c), is amended by adding 
at the end the following: 
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‘‘SEC. 422. NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED ARTI-
CLES OF FOOD. 
‘‘(a) NOTIFICATION TO SECRETARY OF VIOLATION.— 
‘‘(1) IN
GENERAL.—A person (other than a 
household consumer or other individual who is the 
intended consumer of an article of food) that has 
reason 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, if consumed, 
may result in illness or injury shall, as soon as prac-
ticable, notify the Secretary of the identity and loca-
tion 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. 
‘‘(b) RECALL AND CONSUMER NOTIFICATION.— 
‘‘(1) VOLUNTARY ACTIONS.—On receiving noti-
fication under subsection (a) or by other means of 
a suspected adulteration or misbranding of food, if 
the Secretary finds that an article of food when in-
troduced into or while in interstate commerce, or 
while held for sale (regardless of whether the first 
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‘‘(B) any reasons why the article of food 
that is the subject of the order should not be 
recalled. 
‘‘(2) TIMING OF HEARINGS.—If a hearing is re-
quested under paragraph (1) with respect to an 
order, the Secretary shall hold the hearing as soon 
as practicable, but not later than 2 business days, 
after the date of issuance of the order. 
‘‘(d) POST-HEARING RECALL ORDERS.— 
‘‘(1) AMENDMENT OF ORDERS.—If, after pro-
viding an opportunity for a hearing (and a hearing 
if requested) under subsection (c), the Secretary de-
termines that an article of food when introduced into 
or while in interstate commerce, or while held for 
sale (regardless of whether the first sale) after ship-
ment in interstate commerce, is adulterated or mis-
branded in a manner that, if consumed, may result 
in illness or injury, the Secretary may, as the Sec-
retary determines to be necessary— 
‘‘(A) amend the order under subsection 
(b)(2)— 
‘‘(i) to require recall of the article or 
other appropriate action; and 
‘‘(ii) to specify a timetable during 
which the recall shall occur; 
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‘‘(B) require periodic reports to the Sec-
retary describing the progress of any such re-
call; and 
‘‘(C) provide notice of such a recall to con-
sumers to which the article was, or may have 
been, distributed. 
‘‘(2) VACATION OF ORDERS.—If, after providing 
an opportunity for a hearing (and a hearing if re-
quested) under subsection (c), the Secretary deter-
mines that adequate grounds do not exist to con-
tinue the actions required by the order, the Sec-
retary shall vacate the order. 
‘‘(e) REMEDIES NOT EXCLUSIVE.—The remedies au-
thorized by this section shall be in addition to any other 
remedies that may be available.’’. 
(c) EFFECTIVE DATE.—Sections 301(qq)(1) and 422 
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. 
Subtitle C—Response 
SEC. 121. ADMINISTRATIVE DETENTION. 
(a) IN GENERAL.—Section 304(h)(1)(A) (21 U.S.C. 
334(h)(1)(A)) is amended by— 
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(1) striking ‘‘credible evidence or information 
indicating’’ and inserting ‘‘reason to believe’’; and 
(2) striking ‘‘presents a threat of serious ad-
verse health consequences or death to humans or 
animals’’ and inserting ‘‘is adulterated or mis-
branded’’. 
(b) REGULATIONS.—Not later than 120 days after 
the date of enactment of this Act, the Secretary shall issue 
an interim final rule amending subpart K of part 1 of title 
21, Code of Federal Regulations, to implement the amend-
ment made by this section. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall take effect 180 days after the date of 
enactment of this Act. 
SEC. 122. CIVIL PENALTIES RELATING TO FOOD. 
(a) IN GENERAL.—Chapter III (21 U.S.C. 331 et 
seq.) is amended by adding after section 303 the following: 
‘‘SEC. 303A. CIVIL PENALTIES RELATING TO FOODS. 
‘‘(a) IN GENERAL.— 
‘‘(1) ASSESSMENT.—The Secretary may assess 
against a person that commits an act prohibited by 
section 301 with respect to an article of food a civil 
penalty for each such act of not more than— 
‘‘(A) $100,000, in the case of an indi-
vidual; and 
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‘‘(B) $500,000, in the case of any other 
person. 
‘‘(2) SEPARATE
OFFENSES.—Each prohibited 
act described in paragraph (1) and each day during 
which the act continues shall be considered to be a 
separate offense. 
‘‘(3) NOTICE
AND
OPPORTUNITY
FOR
HEAR-
ING.—The Secretary shall not assess a civil penalty 
under this section against a person unless the person 
is given notice and opportunity for a hearing on the 
record before the Secretary in accordance with sec-
tions 554 and 556 of title 5, United States Code. 
‘‘(4) DETERMINATION
OF
CIVIL
PENALTY 
AMOUNT.—The amount of a civil penalty under this 
section— 
‘‘(A) shall be assessed by the Secretary by 
written order, taking into account— 
‘‘(i) the gravity of the violation; 
‘‘(ii) the degree of culpability of the 
person; 
‘‘(iii) the size and type of the business 
of the person; and 
‘‘(iv) any history of prior offenses by 
the person; and 
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‘‘(B) shall be reviewed only in accordance 
with subsection (b). 
‘‘(b) JUDICIAL REVIEW.— 
‘‘(1) IN GENERAL.—An order assessing a civil 
penalty against a person under subsection (a) shall 
be final unless the person— 
‘‘(A) not later than 30 days after the effec-
tive date of the order, files a petition for judi-
cial review of the order in— 
‘‘(i) the United States court of ap-
peals for the circuit in which the person re-
sides or has its principal place of business; 
or 
‘‘(ii) the United States Court of Ap-
peals for the District of Columbia Circuit; 
and 
‘‘(B) simultaneously sends a copy of the 
petition by certified mail to the Secretary. 
‘‘(2) FILING OF COPY OF RECORD.—The Sec-
retary shall promptly file in the court a certified 
copy of the record on which the order was issued. 
‘‘(3) STANDARD OF REVIEW.—The findings of 
the Secretary relating to the order shall be set aside 
only if the findings are found to be unsupported by 
substantial evidence on the record as a whole. 
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‘‘(c) COLLECTION ACTIONS FOR FAILURE TO PAY 
ASSESSMENT.— 
‘‘(1) REFERRAL TO ATTORNEY GENERAL.—If a 
person fails to pay a civil penalty assessed under 
subsection (a) after the order assessing the civil pen-
alty has become a final order, or after the court of 
appeals has entered final judgment in favor of the 
Secretary, the Secretary may refer the matter to the 
Attorney General. 
‘‘(2) ACTION
BY
ATTORNEY
GENERAL.—The 
Attorney General shall bring a civil action to recover 
the amount of the civil penalty in United States dis-
trict court. 
‘‘(3) SCOPE
OF
REVIEW.—In a civil action 
under paragraph (2), the validity and appropriate-
ness of the order of the Secretary assessing the civil 
penalty shall not be subject to review. 
‘‘(d) PENALTIES DEPOSITED
IN TREASURY.—All 
amounts collected as civil penalties under this section shall 
be deposited in the Treasury of the United States and 
shall be available to cover costs of the Administration in 
carrying out food safety activities under this Act. 
‘‘(e) PENALTIES IN LIEU OF OTHER ACTIONS.— 
Nothing in this Act requires the Secretary to report for 
prosecution, or for the commencement of any libel or in-
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junction proceeding, any violation of this Act in any case 
in which the Secretary believes that the public interest will 
be adequately served by the assessment of a civil penalty 
under this section. 
‘‘(f) REMEDIES NOT EXCLUSIVE.—The remedies au-
thorized by this section shall be in addition to any other 
remedies that may be available.’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply to prohibited acts committed on 
or after the date of the enactment of this Act . 
SEC. 123. FAILURE TO CONSENT TO INVESTIGATION. 
Section 801 (21 U.S.C. 381) is amended by adding 
at the end the following: 
‘‘(p) The Secretary may deny importation of food, 
other than only for personal use, from any foreign country, 
or which is manufactured, processed, packed, or held by 
a facility (as defined in section 415), if the government 
of such country, or such facility, respectively, does not 
timely consent to an investigation by the Administration 
when food from that country or facility is linked to a food- 
borne illness outbreak or is otherwise found to be adulter-
ated or mislabeled.’’. 
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Subtitle D—Miscellaneous 
SEC. 131. LABELING REQUIREMENT FOR MEAT, POULTRY 
PRODUCTS, AND SEAFOOD THAT CONTAIN 
CARBON MONOXIDE. 
(a) LABELING REQUIREMENT.— 
(1) IN GENERAL.—Paragraph (t) of section 201 
(21 U.S.C. 321) is amended by adding at the end 
the following: 
‘‘(4) In the case of food that is meat within the mean-
ing of the Federal Meat Inspection Act, a poultry product 
within the meaning of the Poultry Products Inspection 
Act, or seafood (including all fresh or saltwater fish, 
molluscan shellfish, crustaceans, and other forms of 
aquatic animal life) intended for human consumption as 
food within the meaning of section 201(f) (referred to col-
lectively in this paragraph as ‘seafood’), the term ‘color 
additive’ shall include carbon monoxide under conditions 
of use that may impart, maintain, preserve, stabilize, fix, 
or otherwise affect the color of fresh meat, poultry prod-
ucts, or seafood, unless the label of such food bears, 
prominently and conspicuously in such place and in such 
manner as to render it likely to be read and understood 
by the ordinary person, the following statement to prevent 
consumer deception and serious risks to the public health: 
‘CONSUMER NOTICE: Carbon monoxide has been used 
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to preserve the color of this product. Do not rely on color 
or the ‘‘use or freeze by’’ date alone to judge the freshness 
of the product.’ ’’. 
(2) EFFECTIVE DATE.—The amendment made 
by this subsection shall apply to food labeled on or 
after the date that is 30 days after the date of the 
enactment of this Act. 
(b) DISCRETIONARY AUTHORITY.—If, not earlier 
than 5 years after the effective date described in sub-
section (a)(2), the Secretary of Health and Human Serv-
ices finds, based on competent and reliable scientific evi-
dence, that the statement prescribed in section 201(t)(4) 
of the Federal Food, Drug, and Cosmetic Act is no longer 
required to prevent consumer deception and other harms, 
then the Secretary is authorized to issue regulations estab-
lishing alternative labeling requirements that are shown 
to be adequate and effective in preventing consumer de-
ception and other harms related to the conditions of use 
of carbon monoxide, including with respect to preventing 
any consumer deception or other harm that may result 
from the actual conditions of carbon monoxide use and 
its potential to impart a persistent color to meat, poultry 
products, or seafood described in such section through a 
reaction with natural pigment. 
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SEC. 132. 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 
of this subsection, of a request for a substance to be deter-
mined by the Secretary to be a GRAS food substance, the 
Secretary shall publish notice of such request in the Fed-
eral Register. 
‘‘(2) Not later than 90 days after the date of publica-
tion of a notice under paragraph (1), the Secretary shall 
determine whether the substance is a GRAS food sub-
stance. 
‘‘(3) A determination by the Secretary of whether a 
substance is a GRAS food substance shall be published 
in the Federal Register. 
‘‘(4) 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 substances used in food prior 
to January 1, 1958, through either scientific procedures 
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or experience based on common use in food) to be safe 
under the conditions of its intended use.’’. 
SEC. 133. COUNTRY OF ORIGIN LABELING; DISCLOSURE OF 
SOURCE OF INGREDIENTS. 
(a) FOOD.—Section 403 (21 U.S.C. 343), as amend-
ed by sections 101(a) and 108(b), is amended by adding 
at the end the following: 
‘‘(bb) In the case of a processed food if— 
‘‘(1) the labeling of the food fails to identify the 
country in which the final processing of the food oc-
curs; and 
‘‘(2) the website for the manufacturer of the 
food fails to identify the country (or countries) of or-
igin for each ingredient in the food. 
‘‘(cc) In the case of non-processed food if— 
‘‘(1) the labeling of the food fails to identify the 
country of origin of the food; and 
‘‘(2) the website for the original packer of the 
food fails to identify the country of origin for the 
food.’’. 
(b) REGULATIONS.—Not later than 180 days after 
the date of the enactment of this Act, the Secretary of 
Health and Human Services shall promulgate final regula-
tions to carry out paragraphs (bb) and (cc) of section 403 
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of the Federal Food, Drug, and Cosmetic Act, as added 
by subsection (a). 
(c) EFFECTIVE DATE.—The requirements of para-
graphs (bb) and (cc) 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. 134. NEW FOOD AND ANIMAL FEED EXPORT CERTIFI-
CATION FEE TO IMPROVE THE ABILITY OF 
UNITED STATES FIRMS TO EXPORT THEIR 
PRODUCTS. 
Part 5 of subchapter C of chapter VII (21 U.S.C. 
371 et seq.), as added by section 101(b) and amended by 
sections 108 and 109, is further amended by adding at 
the end the following: 
‘‘SEC. 741D. NEW FOOD AND ANIMAL FEED EXPORT CER-
TIFICATION FEE TO IMPROVE THE ABILITY 
OF UNITED STATES FIRMS TO EXPORT THEIR 
PRODUCTS. 
‘‘(a) IN GENERAL.—If the Secretary provides for the 
issuance of export certificates for foods and animal feeds 
in cases where exportation is restricted without such a cer-
tificate, the Secretary may impose a fee for the issuance 
of such a certificate. 
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‘‘(b) AMOUNT.—The amount of the fee under this 
section shall be an amount that is reasonably related to 
the cost of issuing such certificates. 
‘‘(c) USE OF FEES.—The Secretary shall make all 
of the fees collected pursuant to this section available sole-
ly to pay for the costs of issuance of such certificates.’’. 
TITLE II—DRUG AND DEVICE 
SAFETY 
SEC. 201. REGISTRATION OF PRODUCERS OF DRUGS AND 
DEVICES; APPLICABLE FEE. 
(a) REGISTRATION.— 
(1) MISBRANDING.—Paragraph (o) of section 
502 (21 U.S.C. 352) is amended by striking ‘‘in any 
State’’. 
(2) EFFECTIVE DATE.—The amendment made 
by paragraph (1) applies only with respect to reg-
istration under section 510 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360) occurring 
on or after the date of the enactment of this Act. 
(b) REGISTRATION FEE.— 
(1) MISBRANDING.—Paragraph (o) of section 
502 (21 U.S.C. 352), as amended by subsection 
(a)(2), is further amended by inserting after ‘‘not 
duly registered under section 510’’ the following: ‘‘or 
in violation of section 736C for failure to pay a fee’’. 
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(2) ESTABLISHMENT.—Part 2 of subchapter C 
of chapter VII (21 U.S.C. 379g et seq.) is amended 
by adding at the end the following: 
‘‘SEC. 736C. REGISTRATION FEE. 
‘‘(a) IN GENERAL.—Except as provided in subsection 
(b) of this section, the Secretary shall assess and collect 
an annual fee for registration under subsection (b), (c), 
(d), or (i) of section 510 to defray increases (as described 
in subsection (g)(2)(A)(ii)) in the costs of inspecting es-
tablishments registered under subsection (b), (c), (d), or 
(i) of section 510 to ensure compliance by such establish-
ments with the requirements of this Act relating to drugs 
or devices. 
‘‘(b) EXCEPTION.—The Secretary shall not assess or 
collect a fee under this section for registration of an estab-
lishment under section 510 on the basis of such establish-
ment’s manufacture, preparation, propagation, or proc-
essing of an excipient of a drug. 
‘‘(c) FEE REVENUE AMOUNTS.— 
‘‘(1) IN
GENERAL.—For each of fiscal years 
2010 through 2014, fees under subsection (a) shall, 
except as provided in subsections (d), (f), and (g), 
be established to generate a total revenue amount 
under subsection (a). 
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‘‘(2) TOTAL
REVENUE
AMOUNT.—Not later 
than September 1, 2010, the Secretary shall trans-
mit to the Congress the total revenue amount under 
paragraph (1) and how such amount was calculated. 
‘‘(3) ANNUAL
FEE
SETTING.—The Secretary 
shall, not later than 60 days before the start of each 
fiscal year that begins after September 30, 2009, es-
tablish, for the next fiscal year, registration fees 
under subsection (a)— 
‘‘(A) based on the total revenue amount 
applicable under paragraph (1); and 
‘‘(B) taking into consideration the dif-
ference in costs of inspections between foreign 
and domestic establishments. 
‘‘(d) ADJUSTMENTS.— 
‘‘(1) INFLATION ADJUSTMENT.—For fiscal year 
2011 and subsequent fiscal years, the revenues es-
tablished in subsection (c)(1) shall be adjusted by 
the Secretary 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; U.S. city average) 
for the 12-month period ending June 30 pre-
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ceding 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 
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. 
The adjustment made each fiscal year by this sub-
section will be added on a compounded basis to the 
sum of all adjustments made each fiscal year after 
fiscal year 2009 under this subsection. 
‘‘(2) WORKLOAD
ADJUSTMENT.—For fiscal 
year 2011 and subsequent fiscal years, after the fee 
revenues established in subsection (c)(1) are ad-
justed for a fiscal year for inflation in accordance 
with paragraph (1), the fee revenues shall be ad-
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justed further for such fiscal year to reflect changes 
in the workload of the Secretary for inspections de-
scribed in subsection (a). With respect to such ad-
justment: 
‘‘(A) The adjustment shall be determined 
by the Secretary based on a weighted average 
of the change in the total amount of inspections 
described in subsection (a). The Secretary shall 
publish in the Federal Register the fee revenues 
and fees resulting from the adjustment and the 
supporting methodologies. 
‘‘(B) Under no circumstances shall the ad-
justment result in fee revenues for a fiscal year 
that are less than the fee revenues for the fiscal 
year established in subsection (c)(1), as ad-
justed for inflation under paragraph (1). Any 
adjustment for changes in inspection activities 
made in setting fees and revenue amounts for 
fiscal year 2011 may not result in the total 
workload adjustment being more than 2 per-
centage points higher than it would have been 
in the absence of the adjustment for changes in 
inspection activities. 
‘‘(C) The Secretary shall contract with an 
independent accounting firm to study the ad-
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