‘‘(E) The number of such facilities that are 
low-risk. 
‘‘(F) The number of such facilities that hold 
food. 
‘‘(8) LIMITATION ON DELEGATION.—The author-
ity 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 Director for the Center 
for Food Safety and Applied Nutrition, 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 subchapter C 
the following: 
‘‘PART 6—FEES RELATING TO FOOD 
‘‘SEC. 743. FACILITY REGISTRATION FEE. 
‘‘(a) IN GENERAL.— 
‘‘(1) ASSESSMENT AND COLLECTION.—Beginning 
in fiscal year 2010, the Secretary shall assess and col-
lect an annual fee for the registration of a facility 
under section 415. 
‘‘(2) PAYABLE DATE.—A fee under this section 
shall be payable— 
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‘‘(A) for a facility that was not registered 
under section 415 for the preceding fiscal year, 
on the date of registration; and 
‘‘(B) for any other facility— 
‘‘(i) for fiscal year 2010, not later than 
the sooner of 90 days after the date of the 
enactment of this part or December 31, 
2009; and 
‘‘(ii) for a subsequent fiscal year, not 
later than December 31 of such fiscal year. 
‘‘(b) FEE AMOUNTS.— 
‘‘(1) IN GENERAL.—The registration fee under 
subsection (a) shall be— 
‘‘(A) for fiscal year 2010, $500; and 
‘‘(B) for fiscal year 2011 and each subse-
quent fiscal year, the fee for fiscal year 2010 as 
adjusted under subsection (c). 
‘‘(2) ANNUAL
FEE
SETTING.—The Secretary 
shall, not later than 60 days before the start of fiscal 
year 2011 and each subsequent fiscal year, establish, 
for the next fiscal year, registration fees under sub-
section (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 
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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 sub-
section (b)(1) shall be adjusted by the Secretary by notice, 
published in the Federal Register, to reflect the greater of— 
‘‘(1) the total percentage change that occurred in 
the Consumer Price Index for all urban consumers 
(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 previous 
fiscal year in basic pay under the General Schedule 
in accordance with section 5332 of title 5, United 
States Code, as adjusted by any locality-based com-
parability 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. 
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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 2010 
under this subsection. 
‘‘(d) LIMITATIONS.— 
‘‘(1) IN
GENERAL.—Fees under subsection (a) 
shall be refunded for a fiscal year beginning after fis-
cal year 2010 unless appropriations for salaries and 
expenses of the Food and Drug Administration for 
such fiscal year (excluding the amount of fees appro-
priated for such fiscal year) are equal to or greater 
than the amount of appropriations for the salaries 
and expenses of the Food and Drug Administration 
for fiscal year 2010 (excluding the amount of fees ap-
propriated for such fiscal year) multiplied by the ad-
justment factor applicable to the fiscal year involved. 
‘‘(2) AUTHORITY.—If the Secretary does not as-
sess 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 assess 
such fees, the Secretary may assess and collect such 
fees, without any modification in the rate, for reg-
istration under section 415 at any time in such fiscal 
year. 
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‘‘(3) ADJUSTMENT FACTOR.—In this subsection, 
the term ‘adjustment factor’ applicable to a fiscal 
year is the Consumer Price Index for all urban con-
sumers (all items; United States city average) for Oc-
tober of the preceding fiscal year divided by such 
Index for October 2009. 
‘‘(e) CREDITING AND AVAILABILITY OF FEES.— 
‘‘(1) IN GENERAL.—Fees authorized under sub-
section (a) shall be collected and available for obliga-
tion only to the extent and in the amount provided 
in advance in appropriations Acts. Such fees are au-
thorized to remain available until expended. Such 
sums as may be necessary may be transferred from 
the Food and Drug Administration salaries and ex-
penses appropriation account without fiscal year lim-
itation to such appropriation account for salaries and 
expenses with such fiscal year limitation. 
‘‘(2) 
COLLECTIONS
AND
APPROPRIATIONS 
ACTS.—The fees authorized by this section— 
‘‘(A) shall be retained in each fiscal year in 
an amount not to exceed the amount specified in 
appropriation Acts, or otherwise made available 
for obligation, for such fiscal year; and 
‘‘(B) shall only be collected and available to 
defray the costs of food safety activities. 
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‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For 
each of fiscal years 2010 through 2014, there are au-
thorized 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 defray the 
costs of food safety activities in order to solicit the 
views of the regulated industry, consumers, and other 
interested stakeholders. 
‘‘(f) COLLECTION
OF UNPAID FEES.—In any case 
where the Secretary does not receive payment of a fee as-
sessed under subsection (a) within 30 days after it is due, 
such fee shall be treated as a claim of the United States 
Government subject to subchapter II of chapter 37 of title 
31, United States Code. 
‘‘(g) CONSTRUCTION.—This section may not be con-
strued to require that the number of full-time equivalent 
positions in the Department of Health and Human Serv-
ices, for officers, employees, and advisory committees not 
engaged in food safety activities, be reduced to offset the 
number of officers, employees, and advisory committees so 
engaged. 
‘‘(h) ANNUAL FISCAL REPORTS.—Beginning with fis-
cal year 2011, not later than 120 days after the end of each 
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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 Pen-
sions of the Senate a report on the implementation 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 committees, 
and costs related to such officers, employees, and 
committees and to contracts with such contrac-
tors; 
‘‘(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 equip-
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ment, and other necessary materials and sup-
plies; and 
‘‘(E) collecting fees under this section and 
accounting for resources allocated for food safety 
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 stand-
ards and preventive controls), risk assessments, haz-
ard analyses, inspection planning and inspections, 
third-party inspections, compliance review and en-
forcement, import review, information technology sup-
port, test development, product sampling, risk com-
munication, and administrative detention).’’. 
(d) TRANSITIONAL PROVISIONS.— 
(1) FEES.—The Secretary of Health and Human 
Services shall first impose the fee established under 
section 743 of the Federal Food, Drug, and Cosmetic 
Act, as added by subsection (c), for fiscal years begin-
ning 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 
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Services shall modify the registration form under sec-
tion 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 subsection 
(c), does not authorize the assessment or collection of 
a fee for registration under section 415 of such Act 
(21 U.S.C. 360) occurring after fiscal year 2014. 
SEC. 102. HAZARD ANALYSIS, RISK-BASED PREVENTIVE 
CONTROLS, FOOD SAFETY PLAN, FINISHED 
PRODUCT TEST RESULTS FROM CATEGORY 1 
FACILITIES. 
(a) HAZARD ANALYSIS, RISK-BASED PREVENTIVE 
CONTROLS, FOOD SAFETY PLAN.— 
(1) ADULTERATED
FOOD.—Section 402 (21 
U.S.C. 342) is amended by adding at the end the fol-
lowing: 
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‘‘(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 fol-
lowing: 
‘‘SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVEN-
TIVE CONTROLS. 
‘‘(a) IN GENERAL.—The owner, operator, or agent of 
a facility shall, in accordance with this section— 
‘‘(1) conduct a hazard analysis (or more than 
one if appropriate); 
‘‘(2) identify, implement, and validate effective 
preventive controls; 
‘‘(3) monitor preventive controls; 
‘‘(4) institute corrective actions when— 
‘‘(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.— 
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‘‘(1) IN
GENERAL.—The owner, operator, or 
agent of a facility shall evaluate whether there are 
any hazards, including hazards due to the source of 
the ingredients, that are reasonably likely to occur in 
the absence of preventive controls that may affect the 
safety, wholesomeness, or sanitation of the food manu-
factured, 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, al-
lergens, and unapproved food and color addi-
tives; and 
‘‘(B) hazards that occur naturally, may be 
unintentionally introduced, or may be inten-
tionally introduced, including by acts of ter-
rorism. 
‘‘(2) IDENTIFIED BY THE SECRETARY.—The Sec-
retary may, by regulation or guidance, identify haz-
ards that are reasonably likely to occur in the absence 
of preventive controls. 
‘‘(3) HAZARD ANALYSIS.—The owner, operator, 
or agent of a facility shall identify and describe the 
hazards evaluated under paragraph (1) or identified 
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under paragraph (2), to the extent applicable to the 
facility, in a hazard analysis. 
‘‘(c) PREVENTIVE CONTROLS.— 
‘‘(1) IN
GENERAL.—The owner, operator, or 
agent of a facility shall identify, implement, and vali-
date effective preventive controls to prevent, eliminate, 
or reduce to acceptable levels the occurrence of any 
hazards 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 preventive 
controls for specific product types to prevent in-
tentional 
or 
unintentional 
contamination 
throughout the supply chain. The owner, oper-
ator, or agent of a facility shall implement any 
preventive controls identified by the Secretary 
under this paragraph. 
‘‘(B) ALTERNATIVE CONTROLS.—Such regu-
lation 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 re-
quest by the Secretary, the owner, operator, or 
agent can present to the Secretary data or other 
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information sufficient to demonstrate that the al-
ternative control effectively addresses the hazard, 
including meeting any applicable performance 
standard. 
‘‘(C) LIMITATION.—Subparagraph (B) shall 
not apply to any preventive control described 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 procedures 
to ensure that, if the preventive controls under subsection 
(c) are not fully implemented or are not effective— 
‘‘(1) no product from such facility enters com-
merce; and 
‘‘(2) appropriate action is taken to reduce the 
likelihood of recurrence of the implementation failure. 
‘‘(f) VERIFICATION.—The owner, operator, or agent of 
a facility shall ensure that— 
‘‘(1) the preventive controls identified under sub-
section (c) have been validated as adequate to control 
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the hazards identified in the hazard analysis under 
subsection (b)(3); 
‘‘(2) the facility is conducting monitoring in ac-
cordance with subsection (d); 
‘‘(3) the facility is taking effective corrective ac-
tions under subsection (e); and 
‘‘(4) the preventive controls are effectively pre-
venting, eliminating, or reducing to an acceptable 
level the occurrence of identified hazards, including 
through the use of environmental and product testing 
programs and other appropriate means. 
‘‘(g) REQUIREMENT TO REANALYZE AND REVISE.— 
‘‘(1) REQUIREMENT.—The owner, operator, or 
agent of a facility shall— 
‘‘(A) review the evaluation under subsection 
(b) for the facility and, as necessary, revise 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 process 
or product that could affect the hazard 
analysis; and 
‘‘(iii) if the Secretary determines that 
it is appropriate to protect public health; 
and 
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‘‘(B) whenever there is a change in the haz-
ard analysis, revise the preventive controls under 
subsection (c) for the facility as necessary to en-
sure that all hazards that are reasonably likely 
to occur are prevented, eliminated, or reduced to 
an acceptable level, or document the basis for the 
conclusion that no such revision is needed. 
‘‘(2) NONDELEGATION.—Any revisions ordered 
by the Secretary under this subsection shall be ordered 
by the Secretary or an official designated by the Sec-
retary. 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 offi-
cial 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 do-
mestic facility or a foreign facility that is required to 
be registered under section 415. 
‘‘(2) PREVENTIVE CONTROLS.—The term ‘preven-
tive controls’ means those risk-based procedures, prac-
tices, and processes that a person knowledgeable about 
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the safe manufacturing, processing, packing, trans-
porting, 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 sci-
entific understanding of safe food manufacturing, 
processing, packing, transporting, or holding at the 
time of the analysis. Those procedures, practices, and 
processes shall include the following, as appropriate: 
‘‘(A) Sanitation procedures and practices. 
‘‘(B) Supervisor, manager, and employee 
hygiene training. 
‘‘(C) Process controls. 
‘‘(D) An allergen control program to mini-
mize potential allergic reactions in humans from 
ingestion of, or contact with, human and animal 
food. 
‘‘(E) Good manufacturing practices. 
‘‘(F) Verification procedures, practices, and 
processes for suppliers and incoming ingredients, 
which may include onsite auditing of suppliers 
and testing of incoming ingredients. 
‘‘(G) Other procedures, practices, and proc-
esses established by the Secretary under sub-
section (c)(2). 
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‘‘(3) HAZARD THAT IS REASONABLY LIKELY TO 
OCCUR.—A food safety hazard that is reasonably like-
ly to occur is one for which a prudent person who, 
as applicable, manufactures, processes, packs, trans-
ports, or holds food, would establish controls because 
experience, illness data, scientific reports, or other in-
formation provides a basis to conclude that there is 
a reasonable possibility that the hazard will occur in 
the type of food being manufactured, processed, 
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, oper-
ator, 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), including 
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those to address hazards or conditions identified by 
the Secretary 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, review 
of monitoring and corrective action records, and pro-
cedures for determining whether the preventive con-
trols are effectively preventing, eliminating, or reduc-
ing to an acceptable level the occurrence of identified 
hazards or conditions, including the use of environ-
mental and product testing programs. 
‘‘(6) A description of the facility’s recordkeeping 
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 ingredi-
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ents or components used in making the food manufac-
tured, processed, packed, transported, or held by such 
facility. 
‘‘(10) A description of the facility’s procedures to 
implement the science-based performance standards 
issued under section 419.’’. 
(3) GUIDANCE OR REGULATIONS.— 
(A) IN GENERAL.—The Secretary of Health 
and Human Services (referred to in this sub-
section as the ‘‘Secretary’’) shall issue guidance 
or promulgate regulations to establish science- 
based standards for conducting a hazard anal-
ysis, documenting hazards, identifying and im-
plementing preventive controls, and documenting 
the implementation of the preventive controls, in-
cluding 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 guide-
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lines or regulations to ensure that the programs 
under sections 418 and 418A of the Federal 
Food, Drug, and Cosmetic Act (as added by 
paragraph (2)) are consistent, to the extent the 
Secretary determines practicable and appro-
priate, with such standards. 
(C) AUTHORITY WITH RESPECT TO CERTAIN 
FACILITIES.—The Secretary may, by regulation, 
exempt or modify the requirements for compli-
ance under this section and the amendments 
made by this section with respect to facilities 
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 processing. 
(D) SMALL BUSINESSES.—The Secretary— 
(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-
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ments of this section and the amendments 
made by this section. 
(4) NO EFFECT ON EXISTING HACCP AUTHORI-
TIES.—Nothing in this section or the amendments 
made by this section limits the authority of the Sec-
retary under the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 301 et seq.) or the Public Health Serv-
ice 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 regula-
tions, such as the Seafood Hazard Analysis Critical 
Controls Points Program, the Juice Hazard Analysis 
Critical Control Program, and the Thermally Proc-
essed 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 intended 
for consumption by animals other than man. 
(6) EFFECTIVE DATE.— 
(A) GENERAL
RULE.—The amendments 
made by subsection (a) and this subsection shall 
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take effect 18 months after the date of the enact-
ment of this Act. 
(B) EXCEPTIONS.—Notwithstanding sub-
paragraph (A)— 
(i) the amendments made by subsection 
(a) and this subsection 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 
(ii) the amendments made by sub-
section (a) and this subsection 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. 
(b) FINISHED PRODUCT TEST RESULTS FROM CAT-
EGORY 1 FACILITIES.— 
(1) ADULTERATION.—Section 402 (21 U.S.C. 
342), as amended by subsection (a), is amended by 
adding at the end the following: 
‘‘(k) If it is manufactured or processed in a facility 
that is in violation of section 418B.’’. 
(2) REQUIREMENTS.—Chapter IV (21 U.S.C. 
341 et seq.) is amended by adding at the end the fol-
lowing: 
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‘‘SEC. 418B. FINISHED PRODUCT TEST RESULTS FROM CAT-
EGORY 1 FACILITIES. 
‘‘(a) AUTHORITY.—Beginning on the date specified in 
subsection (c), the Secretary shall require, after public no-
tice and an opportunity for comment, the submission to the 
Secretary of finished product test results by the owner, oper-
ator, or agent of each category 1 facility subject to good 
manufacturing practices regulations documenting the pres-
ence of contaminants in food in the possession or control 
of such facility posing a risk of severe adverse health con-
sequences or death. 
‘‘(b) CONSIDERATIONS.—The Secretary shall require 
submissions under subsection (a)— 
‘‘(1) as the Secretary determines feasible and ap-
propriate; 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. 
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‘‘(d) PILOT PROJECTS.—The Secretary shall conduct 
2 or more pilot projects to evaluate the feasibility of col-
lecting positive finished product testing results from cat-
egory 1 facilities, including the value and feasibility of re-
porting corrective actions taken when positive finished 
product test results are reported to the Secretary. 
‘‘(e) FEASIBILITY STUDY.—The Secretary shall assess 
the feasibility and benefits of the reporting by facilities sub-
ject to good manufacturing practices regulations of appro-
priate finished product testing results from category 1 fa-
cilities to the Secretary, including the extent to which the 
collection of such finished product testing results will help 
the Secretary assess the risk presented by a facility or prod-
uct category. 
‘‘(f) LIMITATIONS.—Nothing in this section shall be 
construed— 
‘‘(1) to require the Secretary to mandate testing 
or submission of test results that the Secretary deter-
mines would not provide useful information in assess-
ing the potential risk presented by a facility or prod-
uct category; or 
‘‘(2) to limit the Secretary’s authority under any 
other provisions of law to require any person to pro-
vide access, or to submit information or test results, 
to the Secretary, including the ability of the Secretary 
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to require field or other testing and to obtain test re-
sults in the course of an investigation of a potential 
food-borne illness or contamination incident. 
‘‘(g) DEFINITION.—In this section, the term ‘category 
1 facility’ means a category 1 facility within the meaning 
of section 704(h).’’. 
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 iden-
tify the most significant food-borne contaminants and the 
most significant resulting hazards. The Secretary shall 
issue, as soon as practicable, through guidance or by regula-
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tion, science-based performance standards (which may in-
clude action levels) applicable to foods or food classes, as 
appropriate, to minimize to an acceptable level, prevent, 
or eliminate the occurrence of such hazards. Such standards 
shall be applicable to foods and food classes. 
‘‘(b) LIST OF CONTAMINANTS.—Following each review 
under subsection (a), the Secretary shall publish in the Fed-
eral Register a list of food-borne contaminants that have 
the greatest adverse impact on public health. In deter-
mining whether a particular food-borne contaminant 
should be added to such list, the Secretary shall consider 
the number and severity of illnesses and the number of 
deaths associated with the foods associated with such con-
taminants. 
‘‘(c) 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 enactment 
of this section, or issued under this section, shall remain 
in effect until revised or revoked by the Secretary.’’. 
(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 section 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 
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hazards identified, or the basis for not addressing any sig-
nificant food-borne hazards identified, including any re-
source limitations or limitations in data that preclude fur-
ther action at that time. 
SEC. 104. SAFETY STANDARDS FOR PRODUCE AND CERTAIN 
OTHER RAW AGRICULTURAL COMMODITIES. 
(a) ADULTERATED FOOD.—Section 402 (21 U.S.C. 
342), as amended by sections 102 and 103(a), is amended 
by adding at the end the following: 
‘‘(m) If it has been grown, harvested, processed, packed, 
sorted, transported, or held under conditions that do not 
meet the standards established under section 419A.’’. 
(b) STANDARDS.—Chapter IV (21 U.S.C. 341 et seq.), 
as amended by sections 102(b) and 103(b), is amended by 
adding at the end the following: 
‘‘SEC. 419A. SAFETY STANDARDS FOR PRODUCE AND CER-
TAIN OTHER RAW AGRICULTURAL COMMOD-
ITIES. 
‘‘(a) STANDARDS.—The Secretary shall establish by 
regulation scientific and risk-based standards for the safe 
growing, harvesting, processing, packing, sorting, trans-
porting, and holding of those types of raw agricultural com-
modities— 
‘‘(1) that are from a plant or a fungus; and 
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‘‘(2) for which the Secretary has determined that 
such standards are reasonably necessary to minimize 
the risk of serious adverse health consequences or 
death to humans or animals. 
‘‘(b) CONTENTS.—The regulations under subsection 
(a)— 
‘‘(1) may set forth such procedures, processes, 
and practices as the Secretary determines to be rea-
sonably necessary— 
‘‘(A) to prevent the introduction of known 
or reasonably foreseeable biological, chemical, 
and physical hazards, including hazards that 
occur naturally, may be unintentionally intro-
duced, or may be intentionally introduced, in-
cluding by acts of terrorism, into raw agricul-
tural commodities that are from a plant or a 
fungus; and 
‘‘(B) to provide reasonable assurances that 
such commodity is not adulterated under section 
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; 
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‘‘(3) may include standards addressing manure 
use, water quality, employee hygiene, sanitation and 
animal control, and temperature controls, as the Sec-
retary 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, watershed- 
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 determines 
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to be equivalent to those established under paragraph 
(1). 
‘‘(c) ENFORCEMENT.—The Secretary may coordinate 
with the Secretary of Agriculture and may contract and 
coordinate with the agency or department designated by the 
Governor of each State to perform activities to ensure com-
pliance with this section.’’. 
(c) TIMING.— 
(1) PROPOSED RULE.—Not later than 18 months 
after the date of enactment of this Act, the Secretary 
of Health and Human Services shall issue a proposed 
rule to carry out section 419A of the Federal Food, 
Drug, and Cosmetic Act, as added by subsection (b). 
(2) FINAL RULE.—Not later than 3 years after 
such date, the Secretary of Health and Human Serv-
ices 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 Anal-
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ysis Critical Control Program, and the Thermally Processed 
Low-Acid Foods Packaged in Hermetically Sealed Con-
tainers standards. 
(e) UPDATE EXISTING GUIDANCE.—Not later than 1 
year after the date of the enactment of this Act, the Sec-
retary 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 ac-
cordance with this section and the amendments made by 
this section. 
SEC. 105. RISK-BASED INSPECTION SCHEDULE. 
(a) IN GENERAL.—Section 704 (21 U.S.C. 374) is 
amended by adding at the end the following: 
‘‘(h)(1) Each facility registered under section 415 shall 
be inspected— 
‘‘(A)(i) by one or more officers duly designated 
under section 702 or other statutory authority by the 
Secretary; 
‘‘(ii) for domestic facilities, by a Federal, State, 
or local official recognized by the Secretary under 
paragraph (2); or 
‘‘(iii) for foreign facilities, by an agency or a 
representative of a country that is recognized by the 
Secretary under paragraph (2); and 
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‘‘(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 Sec-
retary for conducting inspections under this Act; and 
‘‘(B) may limit such recognition to inspections 
of specific commodities or food types. 
‘‘(3) The risk-based schedule under paragraph (1)(B) 
shall be implemented beginning not later than 18 months 
after the date of the enactment of this subsection. 
‘‘(4) Such risk-based schedule shall provide for a fre-
quency of inspections commensurate with the risk presented 
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 category 
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 Secretary 
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shall randomly inspect a category 2 facility at least 
every 18 months to 3 years. 
‘‘(C) CATEGORY 3.—A category 3 food facility is 
a facility that holds food. The Secretary shall ran-
domly inspect a category 3 facility at least every 5 
years. 
‘‘(5) The Secretary— 
‘‘(A) may, by guidance, modify the types of food 
facilities within a category under paragraph (4); 
‘‘(B) may alter the inspection frequencies speci-
fied in paragraph (4) based on the need to respond 
to food-borne illness outbreaks and food recalls; 
‘‘(C) may inspect a facility more frequently than 
the inspection frequency provided by paragraph (4); 
‘‘(D) beginning 6 months after submitting the re-
port 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 Sec-
retary’s recommendations in such report; and 
‘‘(ii) after such publication, implement the 
adjustments; and 
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‘‘(E) except as provided in subparagraphs (B) 
and (C), may not alter the inspection frequency speci-
fied in paragraph (4)(A) for category 1 food facilities. 
‘‘(6) In determining the appropriate frequency of in-
spection, the Secretary shall consider— 
‘‘(A) the type of food manufactured, processed, 
packed, or held at the facility; 
‘‘(B) the compliance history of the facility; 
‘‘(C) whether the facility importing or offering 
for import into the United States food is certified by 
a qualified certifying entity in accordance with sec-
tion 801(p); and 
‘‘(D) such other factors as the Secretary deter-
mines by guidance to be relevant to assessing the risk 
presented by the facility.’’. 
(b) REPORTS ON RISK-BASED INSPECTIONS OF FOOD 
FACILITIES.— 
(1) ANNUAL REPORT.—Not later than December 
31 of each year, the Secretary of Health and Human 
Services shall submit a report to the Committee on 
Energy and Commerce of the House of Representa-
tives and the Committee on Health, Education, 
Labor, and Pensions of the Senate describing— 
(A) the number of foreign and domestic fa-
cilities, by risk category, inspected under the 
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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 adjust-
ments 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 the fol-
lowing— 
(A) the nature of the food products being 
processed, stored, or transported; 
(B) the manner in which food products are 
processed, stored, or transported; 
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(C) the inherent likelihood that the products 
will contribute to the risk of food-borne illness; 
(D) the best available evidence concerning 
reported illnesses associated with the foods proc-
essed, 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.—Each person who pro-
duces, manufactures, processes, packs, transports, 
distributes, receives, or holds an article of food in 
the United States or for import into the United 
States shall, at the request of an officer or em-
ployee duly designated by the Secretary, permit 
such officer or employee, upon presentation of 
appropriate credentials, at reasonable times and 
within reasonable limits and in a reasonable 
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manner, to have access to and copy all records 
relating 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 sec-
tion 418 or 418A. 
‘‘(B) SCOPE
OF
RECORDS.—The require-
ment under subparagraph (A) applies to all 
records relating to the production, manufacture, 
processing, packing, transporting, distribution, 
receipt, holding, or importation of such article 
maintained by or on behalf of such person in 
any format (including paper and electronic for-
mats) and at any location. 
‘‘(C) IMMEDIATE
AVAILABILITY
WITH
NO-
TICE.—Records not required to be made avail-
able immediately on commencement of an in-
spection under subparagraph (A) shall nonethe-
less be made available immediately on com-
mencement of such an inspection if, by a reason-
able time before such inspection, the Secretary by 
letter to the person identifies the records to be 
made available during such inspection. 
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‘‘(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 ar-
ticle of food presents a threat of serious adverse 
health consequences or death to humans or ani-
mals, the Secretary may require each person who 
manufactures, processes, packs, transports, dis-
tributes, 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 rea-
sonably practicable, after receiving written no-
tice (including by notice served personally and 
outside normal business hours to an agent iden-
tified under subparagraph (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 Secretary, 
as soon as reasonably practicable after receiving 
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written notice of such requirement, the food safe-
ty plan, supporting information relied on by the 
facility to select the preventive controls to in-
clude 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 Secretary 
under subparagraph (A) or (B) are available in 
electronic format, such records shall be submitted 
electronically unless the Secretary specifies other-
wise in the notice under such subparagraph.’’. 
(b) REGULATIONS CONCERNING RECORDKEEPING.— 
(1) AMENDMENT.—Subsection (b) of section 414 
(21 U.S.C. 350c) is amended to read as follows: 
‘‘(b) REGULATIONS CONCERNING RECORDKEEPING.— 
The Secretary, in consultation and coordination, as appro-
priate, with other Federal departments and agencies with 
responsibilities for regulating food safety, may by regula-
tion establish requirements regarding the establishment and 
maintenance, for not longer than 3 years, of records by per-
sons who produce, 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 
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under this section. The only distribution records which may 
be required of restaurants under this subsection are those 
showing the restaurant’s suppliers and subsequent distribu-
tion other than to consumers.’’. 
(2) APPLICATION.—The Secretary of Health and 
Human Services shall promulgate revised regulations 
to implement section 414(b) of the Federal Food, 
Drug, and Cosmetic Act, as amended by this sub-
section. 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 enactment of 
this Act, shall apply to acts and omissions occurring 
before the effective date of such revised regulations. 
(c) CONFORMING AMENDMENTS.—Section 704(a)(1) 
(21 U.S.C. 374(a)(1)) is amended— 
(1) in the first sentence— 
(A) by inserting ‘‘farm,’’ before ‘‘factory’’ 
each place it appears; and 
(B) by inserting ‘‘produced,’’ before ‘‘manu-
factured’’; 
(2) in the second sentence— 
(A) by striking ‘‘(excluding farms and res-
taurants)’’; 
(B) by inserting ‘‘produces,’’ before ‘‘manu-
factures’’; 
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(C) by inserting ‘‘receives,’’ before ‘‘holds’’; 
(D) by striking ‘‘described in section 414’’ 
and inserting ‘‘described in or required under 
section 414’’; and 
(E) by striking ‘‘when the Secretary has a 
reasonable belief that an article of food is adul-
terated and presents a threat of serious adverse 
health consequences or death to humans or ani-
mals’’ and inserting ‘‘bearing on whether such 
food is adulterated, misbranded, or otherwise in 
violation of this Act, including all records col-
lected or developed to comply with section 418 or 
418A’’; and 
(3) in the fourth sentence— 
(A) by striking ‘‘the preceding sentence’’ 
and inserting ‘‘either of the preceding two sen-
tences’’; and 
(B) by inserting ‘‘recipes for food,’’ before 
‘‘financial data,’’. 
SEC. 107. TRACEABILITY OF FOOD. 
(a) PROHIBITED ACT.—Section 301(e) (21 U.S.C. 
331(e)) is amended by inserting ‘‘, the violation of any re-
quirement 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’’. 
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(b) IMPORTS.—Section 801(a) (21 U.S.C. 381(a)) is 
amended by inserting ‘‘or (4) the requirements of section 
414 have not been complied with regarding such article,’’ 
before ‘‘then such article shall be refused admission’’. 
(c) PRODUCT TRACING FOR FOOD.—Section 414 (21 
U.S.C. 350c), as amended by section 106, is amended— 
(1) by redesignating subsections (c) and (d) as 
subsections (d) and (e), respectively; and 
(2) by inserting after subsection (b) the fol-
lowing: 
‘‘(c) TRACING SYSTEM FOR FOOD.— 
‘‘(1) IN GENERAL.—The Secretary shall by regu-
lation 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 history 
of a food that are, or may be, used by mem-
bers of different sectors of the food industry, 
including technologies and methodologies to 
enable each person who produces, manufac-
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tures, processes, pack, transports, or holds a 
food to— 
‘‘(I) maintain the full pedigree of 
the origin and previous distribution 
history of the food; 
‘‘(II) link that history with the 
subsequent distribution of the food; 
‘‘(III) establish and maintain a 
system for tracing the food that is 
interoperable with the systems estab-
lished and maintained by other such 
persons; and 
‘‘(IV) use a unique identifier for 
each facility owned or operated by such 
person for such purpose, as specified 
under section 911; and 
‘‘(ii) to the extent practicable, assess— 
‘‘(I) the costs and benefits associ-
ated with the adoption and use of such 
technologies; 
‘‘(II) the feasibility of such tech-
nologies for different sectors of the food 
industry; and 
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‘‘(III) whether such technologies 
are compatible with the requirements 
of this subsection. 
‘‘(B) PUBLIC MEETINGS.—Before issuing a 
proposed regulation under this subsection, the 
Secretary shall conduct not less than 2 public 
meetings in diverse geographical areas of the 
United States to provide persons in different re-
gions an opportunity to provide input and infor-
mation to the Secretary. 
‘‘(C) PILOT
PROJECTS.—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. 
‘‘(3) REGULATION.—Taking into account infor-
mation obtained through information gathering under 
paragraph (2), the Secretary shall issue regulations 
establishing a tracing system that enables the Sec-
retary to identify each person who grows, produces, 
manufactures, processes, packs, transports, holds, or 
sells such food in as short a timeframe as practicable 
but no longer than 2 business days. The Secretary 
may include in such regulation— 
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‘‘(A) the establishment and maintenance of 
lot numbers; 
‘‘(B) a standardized format for pedigree in-
formation; and 
‘‘(C) the use of a common nomenclature for 
food. 
‘‘(4) EXEMPTIONS.— 
‘‘(A) DIRECT SALES BY FARMS.—Food is 
exempt from the requirements of this subsection 
if such food is— 
‘‘(i) produced on a farm or fishery (in-
cluding an oyster bed, a wild fishery, an 
aquaculture facility, a fresh water fishery, 
and a saltwater fishery); and 
‘‘(ii) sold by the owner, operator, or 
agent in charge of such farm or fishery di-
rectly to a consumer or to a restaurant or 
grocery store. 
‘‘(B) OTHER FOODS.—The Secretary may 
by notice in the Federal Register exempt a food 
or a type of facility, farm, or restaurant from, 
or modify the requirements with respect to, the 
requirements of this subsection if the Secretary 
determines that a tracing system for such food or 
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type of facility, farm, or restaurant is not nec-
essary to protect the public health. 
‘‘(C) PREVIOUS SOURCES AND SUBSEQUENT 
RECIPIENTS.—For a food covered by an exemp-
tion under subparagraph (B), the Secretary shall 
require each person who produces, manufactures, 
processes, packs, transports, or holds such food to 
maintain records to identify the immediate pre-
vious sources of such food and its ingredients 
and the immediate subsequent recipients of such 
food. 
‘‘(D) 
RESTAURANTS
AND
GROCERY 
STORES.—For a food covered by an exemption 
under subparagraph (A), restaurants and gro-
cery stores shall keep records documenting the 
farm that was the source of the food. 
‘‘(E) FARMS AND FISHERIES.—For a food 
covered by an exemption under subparagraph 
(A), farms and fisheries shall keep records, in 
electronic or non-electronic format, for at least 6 
months documenting the restaurant or grocery 
store to which the food was sold.’’. 
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SEC. 108. REINSPECTION AND FOOD RECALL FEES APPLICA-
BLE 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 col-
lect 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— 
‘‘(1) in the case of fees collected under subsection 
(a)(1), conducting the additional inspections referred 
to in such subsection; and 
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‘‘(2) in the case of fees collected under subsection 
(a)(2), conducting food recall activities, including 
technical assistance, follow-up effectiveness checks, 
and public notifications, during the fiscal year in-
volved. 
‘‘(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 available 
for obligation, for such fiscal year; and 
‘‘(B) shall only be collected and available to 
defray the costs referred to in subsection (b). 
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‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For 
each of fiscal years 2010 through 2014, there are au-
thorized 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 sub-
section (a) shall apply to additional inspections and food 
recall activities occurring after the date of the enactment 
of this Act. 
SEC. 109. CERTIFICATION AND ACCREDITATION. 
(a) MISBRANDING.— 
(1) IN GENERAL.—Section 403 (21 U.S.C. 343), 
as amended by section 101(a), is amended by adding 
at the end the following: 
‘‘(aa) If it is part of a shipment offered for import 
into the United States and such shipment is in violation 
of section 801(p) (requiring a certification to accompany 
certain food shipments).’’. 
(2) EFFECTIVE DATE.—The amendment made by 
paragraph (1) shall apply to shipments offered for 
import on or after the date that is 3 years after the 
date of the enactment of this Act. 
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(b) CERTIFICATION OF COMPLIANCE FOR IMPORTS.— 
Chapter VIII (21 U.S.C. 381 et seq.) is amended— 
(1) in section 801(a), as amended by section 
107(b), by inserting after the third sentence the fol-
lowing: ‘‘If an article of food being imported or of-
fered for import into the United States is not in com-
pliance with the requirement of subsection (p) (relat-
ing to certifications of compliance with this Act), then 
such article shall be refused admission.’’; 
(2) in the second sentence of section 801(b), by 
striking ‘‘the fourth sentence’’ and inserting ‘‘the fifth 
sentence’’; and 
(3) by adding at the end of section 801 the fol-
lowing: 
‘‘(p) CERTIFICATIONS CONCERNING IMPORTED ARTI-
CLES.— 
‘‘(1) IN GENERAL.— 
‘‘(A) REQUIREMENT.—The Secretary shall 
require, as an additional condition of granting 
admission to an article of food being imported or 
offered for import into the United States, that a 
qualified certifying entity provide a certification 
that the article complies with specified require-
ments of this Act if— 
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‘‘(i) for food imported from a par-
ticular country or region, based on the ade-
quacy of government controls in such coun-
try or region or other information relevant 
to such food, certification would assist the 
Secretary in determining whether to refuse 
to admit such article under subsection (a); 
‘‘(ii) for a type of food that could pose 
a significant risk to health, certification 
would assist the Secretary in determining 
whether such article poses such risk; or 
‘‘(iii) for an article imported from a 
particular country, there is an agreement 
between the Secretary and the government 
of such country providing for such certifi-
cation. 
‘‘(B) CONTENTS OF CERTIFICATION.—Such 
certification shall include such information re-
garding compliance as the Secretary may speci-
fy, and may be provided in the form of ship-
ment-specific certificates, a listing of certified fa-
cilities or other entities, or in such other form as 
the Secretary may specify. 
‘‘(C) NOTICE OF CANCELLATION OR SUSPEN-
SION OF CERTIFICATION.—As a condition on ac-
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ceptance of certifications from a qualified certi-
fying entity, the Secretary shall require the 
qualified certifying entity to notify the Secretary 
whenever the qualified certifying entity cancels 
or suspends the certification of any facility or 
other entity included in a listing under subpara-
graph (B). 
‘‘(2) QUALIFIED CERTIFYING ENTITY.—For pur-
poses of this subsection, the term ‘qualified certifying 
entity’ means— 
‘‘(A) an agency or a representative of the 
government of the country from which the article 
originated, as designated by such government 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 cer-
tification under paragraph (1). 
‘‘(3) NO CONFLICTS OF INTEREST.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
issue regulations to ensure that any qualified 
certifying entity and its auditors are free from 
conflicts of interest. 
‘‘(B) 
REGULATIONS.—Such 
regulations 
shall require that— 
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‘‘(i) the qualified certifying entity shall 
have a committee or management structure 
for safeguarding impartiality; 
‘‘(ii) conflict of interest policies for a 
qualified certifying entity and auditors act-
ing for the qualified certifying entity shall 
be written; 
‘‘(iii) the qualified certifying entity 
shall not be owned, operated, or controlled 
by a producer, manufacturer, processor, 
packer, holder, supplier, or vendor of any 
article of the type it certifies; 
‘‘(iv) the qualified certifying entity 
shall not have any ownership or financial 
interest in any product, producer, manufac-
turer, processor, packer, holder, supplier or 
vendor of the type it certifies; 
‘‘(v) no auditor acting for the qualified 
certifying entity (or spouse or minor chil-
dren) shall have any significant ownership 
or other financial interest regarding any 
product of the type it certifies; 
‘‘(vi) the qualified certifying entity 
shall maintain records pertaining to the fi-
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nancial interests of the personnel involved 
in audits; 
‘‘(vii) neither the qualified certifying 
entity nor any of its auditors acting for the 
qualified certifying entity shall participate 
in the production, manufacture, processing, 
packing, holding, promotion, or sale of any 
product of the type it certifies; 
‘‘(viii) neither the qualified certifying 
entity nor any of its auditors shall provide 
consultative services to any facility certified 
by the qualified certifying entity, or the 
owner, operator, or agent in charge of such 
a facility, unless the qualified certifying en-
tity has procedures in place, approved by 
the Secretary, to ensure separation of func-
tions between auditors providing consult-
ative services and auditors providing cer-
tification services under this subsection; 
‘‘(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 
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by the qualified certifying entity or any 
personnel involved in the audit process; 
‘‘(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 impar-
tiality; 
‘‘(xiv) the qualified certifying entity 
and its auditors shall sign a statement at-
testing to compliance with the conflict of in-
terests requirements under this paragraph; 
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 violation 
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of this subsection to the extent such sub-
contractors perform additional nutritional 
testing services unrelated to the testing 
under this subsection. 
‘‘(C) ANYTHING OF VALUE.—In this para-
graph, the term ‘anything of value’ includes 
gifts, gratuities, reimbursement of expenses, en-
tertainment, loans, or any other form of com-
pensation in cash or in kind. 
‘‘(4) RENEWAL
AND
REFUSAL
OF
CERTIFI-
CATIONS.—The Secretary shall— 
‘‘(A) require that, to the extent applicable, 
any certification provided by a qualified certi-
fying entity be renewed by such entity at such 
times as the Secretary determines appropriate; 
and 
‘‘(B) refuse to accept any certification if the 
Secretary determines that such certification is no 
longer valid or reliable. 
‘‘(5) ELECTRONIC SUBMISSION.—The Secretary 
shall provide for the electronic submission of certifi-
cations under this subsection. 
‘‘(6) NO LIMIT ON AUTHORITY.—This subsection 
shall not be construed to limit the authority of the 
Secretary to conduct random inspections of imported 
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articles or facilities of importers, issue import alerts 
for detention without physical examination, require 
submission to the Secretary of documentation or other 
information about an article imported or offered for 
import, or to take such other steps as the Secretary 
deems appropriate to determine the admissibility of 
imported articles.’’. 
SEC. 110. TESTING BY ACCREDITED LABORATORIES. 
(a) PROHIBITED ACT.—Section 301 (21 U.S.C. 331) 
is amended by adding at the end the following: 
‘‘(oo) The violation of any requirement of section 714 
(relating to testing by accredited laboratories).’’. 
(b) LABORATORY ACCREDITATION.—Subchapter A of 
chapter VII (21 U.S.C. 371 et seq.) is amended by adding 
at the end the following: 
‘‘SEC. 714. TESTING BY ACCREDITED LABORATORIES. 
‘‘(a) IN GENERAL.— 
‘‘(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 
other purposes as the Secretary deems appropriate 
through regulation or guidance, such testing shall be 
conducted by a laboratory that— 
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‘‘(A) is accredited, for the analytical method 
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 samples 
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 conducted 
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-
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. 
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‘‘(c) ONSITE AUDITS.—In evaluating whether an ac-
creditation body meets, or continues to meet, the standards 
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 Sec-
retary and upon presentation of appropriate creden-
tials, at reasonable times and within reasonable lim-
its 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 ACCREDI-
TATION BODIES.—The Secretary shall publish and main-
tain on the public Web site of the Food and Drug Adminis-
tration a list of accreditation bodies recognized by the Sec-
retary 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 Secretary 
whenever it accredits a laboratory for the purposes of this 
section and whenever it withdraws or suspends such accred-
itation. 
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