H. R. 2751—39 
that receives and distributes non-alcohol food, provided such food 
is received and distributed— 
(1) in a prepackaged form that prevents any direct human 
contact with such food; and 
(2) in amounts that constitute not more than 5 percent 
of the overall sales of such facility, as determined by the Sec-
retary of the Treasury. 
(c) RULE OF CONSTRUCTION.—Except as provided in subsections 
(a) and (b), this section shall not be construed to exempt any 
food, other than alcoholic beverages, as defined in section 214 
of the Federal Alcohol Administration Act (27 U.S.C. 214), from 
the requirements of this Act (including the amendments made 
by this Act). 
TITLE II—IMPROVING CAPACITY TO DE-
TECT AND RESPOND TO FOOD SAFETY 
PROBLEMS 
SEC. 201. TARGETING OF INSPECTION RESOURCES FOR DOMESTIC 
FACILITIES, FOREIGN FACILITIES, AND PORTS OF ENTRY; 
ANNUAL REPORT. 
(a) TARGETING
OF
INSPECTION
RESOURCES
FOR
DOMESTIC 
FACILITIES, FOREIGN FACILITIES, AND PORTS OF ENTRY.—Chapter 
IV (21 U.S.C. 341 et seq.), as amended by section 106, is amended 
by adding at the end the following: 
‘‘SEC. 421. TARGETING OF INSPECTION RESOURCES FOR DOMESTIC 
FACILITIES, FOREIGN FACILITIES, AND PORTS OF ENTRY; 
ANNUAL REPORT. 
‘‘(a) IDENTIFICATION AND INSPECTION OF FACILITIES.— 
‘‘(1) IDENTIFICATION.—The Secretary shall identify high- 
risk facilities and shall allocate resources to inspect facilities 
according to the known safety risks of the facilities, which 
shall be based on the following factors: 
‘‘(A) The known safety risks of the food manufactured, 
processed, packed, or held at the facility. 
‘‘(B) The compliance history of a facility, including 
with regard to food recalls, outbreaks of foodborne illness, 
and violations of food safety standards. 
‘‘(C) The rigor and effectiveness of the facility’s hazard 
analysis and risk-based preventive controls. 
‘‘(D) Whether the food manufactured, processed, 
packed, or held at the facility meets the criteria for priority 
under section 801(h)(1). 
‘‘(E) Whether the food or the facility that manufac-
tured, processed, packed, or held such food has received 
a certification as described in section 801(q) or 806, as 
appropriate. 
‘‘(F) Any other criteria deemed necessary and appro-
priate by the Secretary for purposes of allocating inspection 
resources. 
‘‘(2) INSPECTIONS.— 
‘‘(A) IN GENERAL.—Beginning on the date of enactment 
of the FDA Food Safety Modernization Act, the Secretary 
shall increase the frequency of inspection of all facilities.
H. R. 2751—40 
‘‘(B) DOMESTIC HIGH-RISK FACILITIES.—The Secretary 
shall increase the frequency of inspection of domestic facili-
ties identified under paragraph (1) as high-risk facilities 
such that each such facility is inspected— 
‘‘(i) not less often than once in the 5-year period 
following the date of enactment of the FDA Food Safety 
Modernization Act; and 
‘‘(ii) not less often than once every 3 years there-
after. 
‘‘(C) DOMESTIC
NON-HIGH-RISK
FACILITIES.—The Sec-
retary shall ensure that each domestic facility that is not 
identified under paragraph (1) as a high-risk facility is 
inspected— 
‘‘(i) not less often than once in the 7-year period 
following the date of enactment of the FDA Food Safety 
Modernization Act; and 
‘‘(ii) not less often than once every 5 years there-
after. 
‘‘(D) FOREIGN FACILITIES.— 
‘‘(i) YEAR 1.—In the 1-year period following the 
date of enactment of the FDA Food Safety Moderniza-
tion Act, the Secretary shall inspect not fewer than 
600 foreign facilities. 
‘‘(ii) SUBSEQUENT YEARS.—In each of the 5 years 
following the 1-year period described in clause (i), the 
Secretary shall inspect not fewer than twice the 
number of foreign facilities inspected by the Secretary 
during the previous year. 
‘‘(E) RELIANCE ON FEDERAL, STATE, OR LOCAL INSPEC-
TIONS.—In meeting the inspection requirements under this 
subsection for domestic facilities, the Secretary may rely 
on inspections conducted by other Federal, State, or local 
agencies under interagency agreement, contract, memo-
randa of understanding, or other obligation. 
‘‘(b) IDENTIFICATION AND INSPECTION AT PORTS OF ENTRY.— 
The Secretary, in consultation with the Secretary of Homeland 
Security, shall allocate resources to inspect any article of food 
imported into the United States according to the known safety 
risks of the article of food, which shall be based on the following 
factors: 
‘‘(1) The known safety risks of the food imported. 
‘‘(2) The known safety risks of the countries or regions 
of origin and countries through which such article of food is 
transported. 
‘‘(3) The compliance history of the importer, including with 
regard to food recalls, outbreaks of foodborne illness, and viola-
tions of food safety standards. 
‘‘(4) The rigor and effectiveness of the activities conducted 
by the importer of such article of food to satisfy the require-
ments of the foreign supplier verification program under section 
805. 
‘‘(5) Whether the food importer participates in the voluntary 
qualified importer program under section 806. 
‘‘(6) Whether the food meets the criteria for priority under 
section 801(h)(1).
H. R. 2751—41 
‘‘(7) Whether the food or the facility that manufactured, 
processed, packed, or held such food received a certification 
as described in section 801(q) or 806. 
‘‘(8) Any other criteria deemed necessary and appropriate 
by the Secretary for purposes of allocating inspection resources. 
‘‘(c) INTERAGENCY AGREEMENTS WITH RESPECT TO SEAFOOD.— 
‘‘(1) IN GENERAL.—The Secretary of Health and Human 
Services, the Secretary of Commerce, the Secretary of Homeland 
Security, the Chairman of the Federal Trade Commission, and 
the heads of other appropriate agencies may enter into such 
agreements as may be necessary or appropriate to improve 
seafood safety. 
‘‘(2) SCOPE OF AGREEMENTS.—The agreements under para-
graph (1) may include— 
‘‘(A) cooperative arrangements for examining and 
testing seafood imports that leverage the resources, 
capabilities, and authorities of each party to the agreement; 
‘‘(B) coordination of inspections of foreign facilities to 
increase the percentage of imported seafood and seafood 
facilities inspected; 
‘‘(C) standardization of data on seafood names, inspec-
tion records, and laboratory testing to improve interagency 
coordination; 
‘‘(D) coordination to detect and investigate violations 
under applicable Federal law; 
‘‘(E) a process, including the use or modification of 
existing processes, by which officers and employees of the 
National Oceanic and Atmospheric Administration may be 
duly designated by the Secretary to carry out seafood 
examinations and investigations under section 801 of this 
Act or section 203 of the Food Allergen Labeling and Con-
sumer Protection Act of 2004; 
‘‘(F) the sharing of information concerning observed 
non-compliance with United States food requirements 
domestically and in foreign nations and new regulatory 
decisions and policies that may affect the safety of food 
imported into the United States; 
‘‘(G) conducting joint training on subjects that affect 
and strengthen seafood inspection effectiveness by Federal 
authorities; and 
‘‘(H) outreach on Federal efforts to enhance seafood 
safety and compliance with Federal food safety require-
ments. 
‘‘(d) COORDINATION.—The Secretary shall improve coordination 
and cooperation with the Secretary of Agriculture and the Secretary 
of Homeland Security to target food inspection resources. 
‘‘(e) FACILITY.—For purposes of this section, the term ‘facility’ 
means a domestic facility or a foreign facility that is required 
to register under section 415.’’. 
(b) ANNUAL REPORT.—Section 1003 (21 U.S.C. 393) is amended 
by adding at the end the following: 
‘‘(h) ANNUAL REPORT REGARDING FOOD.—Not later than Feb-
ruary 1 of each year, the Secretary shall submit to Congress a 
report, including efforts to coordinate and cooperate with other 
Federal 
agencies 
with 
responsibilities 
for 
food 
inspections, 
regarding— 
‘‘(1) information about food facilities including—
H. R. 2751—42 
‘‘(A) the appropriations used to inspect facilities reg-
istered pursuant to section 415 in the previous fiscal year; 
‘‘(B) the average cost of both a non-high-risk food 
facility inspection and a high-risk food facility inspection, 
if such a difference exists, in the previous fiscal year; 
‘‘(C) the number of domestic facilities and the number 
of foreign facilities registered pursuant to section 415 that 
the Secretary inspected in the previous fiscal year; 
‘‘(D) the number of domestic facilities and the number 
of foreign facilities registered pursuant to section 415 that 
were scheduled for inspection in the previous fiscal year 
and which the Secretary did not inspect in such year; 
‘‘(E) the number of high-risk facilities identified pursu-
ant to section 421 that the Secretary inspected in the 
previous fiscal year; and 
‘‘(F) the number of high-risk facilities identified pursu-
ant to section 421 that were scheduled for inspection in 
the previous fiscal year and which the Secretary did not 
inspect in such year. 
‘‘(2) information about food imports including— 
‘‘(A) the number of lines of food imported into the 
United States that the Secretary physically inspected or 
sampled in the previous fiscal year; 
‘‘(B) the number of lines of food imported into the 
United States that the Secretary did not physically inspect 
or sample in the previous fiscal year; and 
‘‘(C) the average cost of physically inspecting or sam-
pling a line of food subject to this Act that is imported 
or offered for import into the United States; and 
‘‘(3) information on the foreign offices of the Food and 
Drug Administration including— 
‘‘(A) the number of foreign offices established; and 
‘‘(B) the number of personnel permanently stationed 
in each foreign office. 
‘‘(i) PUBLIC AVAILABILITY OF ANNUAL FOOD REPORTS.—The Sec-
retary shall make the reports required under subsection (h) avail-
able to the public on the Internet Web site of the Food and Drug 
Administration.’’. 
(c) ADVISORY COMMITTEE CONSULTATION.—In allocating inspec-
tion resources as described in section 421 of the Federal Food, 
Drug, and Cosmetic Act (as added by subsection (a)), the Secretary 
may, as appropriate, consult with any relevant advisory committee 
within the Department of Health and Human Services. 
SEC. 202. LABORATORY ACCREDITATION FOR ANALYSES OF FOODS. 
(a) IN GENERAL.—Chapter IV (21 U.S.C. 341 et seq.), as 
amended by section 201, is amended by adding at the end the 
following: 
‘‘SEC. 422. LABORATORY ACCREDITATION FOR ANALYSES OF FOODS. 
‘‘(a) RECOGNITION OF LABORATORY ACCREDITATION.— 
‘‘(1) IN GENERAL.—Not later than 2 years after the date 
of enactment of the FDA Food Safety Modernization Act, the 
Secretary shall— 
‘‘(A) establish a program for the testing of food by 
accredited laboratories; 
‘‘(B) establish a publicly available registry of accredita-
tion bodies recognized by the Secretary and laboratories
H. R. 2751—43 
accredited by a recognized accreditation body, including 
the name of, contact information for, and other information 
deemed appropriate by the Secretary about such bodies 
and laboratories; and 
‘‘(C) require, as a condition of recognition or accredita-
tion, as appropriate, that recognized accreditation bodies 
and accredited laboratories report to the Secretary any 
changes that would affect the recognition of such accredita-
tion body or the accreditation of such laboratory. 
‘‘(2) PROGRAM
REQUIREMENTS.—The program established 
under paragraph (1)(A) shall provide for the recognition of 
laboratory accreditation bodies that meet criteria established 
by the Secretary for accreditation of laboratories, including 
independent private laboratories and laboratories run and oper-
ated by a Federal agency (including the Department of Com-
merce), State, or locality with a demonstrated capability to 
conduct 1 or more sampling and analytical testing methodolo-
gies for food. 
‘‘(3) INCREASING
THE
NUMBER
OF
QUALIFIED
LABORA-
TORIES.—The Secretary shall work with the laboratory accredi-
tation bodies recognized under paragraph (1), as appropriate, 
to increase the number of qualified laboratories that are eligible 
to perform testing under subparagraph (b) beyond the number 
so qualified on the date of enactment of the FDA Food Safety 
Modernization Act. 
‘‘(4) LIMITED
DISTRIBUTION.—In the interest of national 
security, the Secretary, in coordination with the Secretary of 
Homeland Security, may determine the time, manner, and form 
in which the registry established under paragraph (1)(B) is 
made publicly available. 
‘‘(5) FOREIGN LABORATORIES.—Accreditation bodies recog-
nized by the Secretary under paragraph (1) may accredit labora-
tories that operate outside the United States, so long as such 
laboratories meet the accreditation standards applicable to 
domestic laboratories accredited under this section. 
‘‘(6) MODEL LABORATORY STANDARDS.—The Secretary shall 
develop model standards that a laboratory shall meet to be 
accredited by a recognized accreditation body for a specified 
sampling or analytical testing methodology and included in 
the registry provided for under paragraph (1). In developing 
the model standards, the Secretary shall consult existing stand-
ards for guidance. The model standards shall include— 
‘‘(A) methods to ensure that— 
‘‘(i) appropriate sampling, analytical procedures 
(including rapid analytical procedures), and commer-
cially available techniques are followed and reports 
of analyses are certified as true and accurate; 
‘‘(ii) internal quality systems are established and 
maintained; 
‘‘(iii) procedures exist to evaluate and respond 
promptly to complaints regarding analyses and other 
activities for which the laboratory is accredited; and 
‘‘(iv) individuals who conduct the sampling and 
analyses are qualified by training and experience to 
do so; and 
‘‘(B) any other criteria determined appropriate by the 
Secretary.
H. R. 2751—44 
‘‘(7) REVIEW OF RECOGNITION.—To ensure compliance with 
the requirements of this section, the Secretary— 
‘‘(A) shall periodically, and in no case less than once 
every 5 years, reevaluate accreditation bodies recognized 
under paragraph (1) and may accompany auditors from 
an accreditation body to assess whether the accreditation 
body meets the criteria for recognition; and 
‘‘(B) shall promptly revoke the recognition of any 
accreditation body found not to be in compliance with the 
requirements of this section, specifying, as appropriate, 
any terms and conditions necessary for laboratories accred-
ited by such body to continue to perform testing as 
described in this section. 
‘‘(b) TESTING PROCEDURES.— 
‘‘(1) IN GENERAL.—Not later than 30 months after the date 
of enactment of the FDA Food Safety Modernization Act, food 
testing shall be conducted by Federal laboratories or non-Fed-
eral laboratories that have been accredited for the appropriate 
sampling or analytical testing methodology or methodologies 
by a recognized accreditation body on the registry established 
by the Secretary under subsection (a)(1)(B) whenever such 
testing is conducted— 
‘‘(A) by or on behalf of an owner or consignee— 
‘‘(i) in response to a specific testing requirement 
under this Act or implementing regulations, when 
applied to address an identified or suspected food safety 
problem; and 
‘‘(ii) as required by the Secretary, as the Secretary 
deems appropriate, to address an identified or sus-
pected food safety problem; or 
‘‘(B) on behalf of an owner or consignee— 
‘‘(i) in support of admission of an article of food 
under section 801(a); and 
‘‘(ii) under an Import Alert that requires successful 
consecutive tests. 
‘‘(2) RESULTS OF TESTING.—The results of any such testing 
shall be sent directly to the Food and Drug Administration, 
except the Secretary may by regulation exempt test results 
from such submission requirement if the Secretary determines 
that such results do not contribute to the protection of public 
health. Test results required to be submitted may be submitted 
to the Food and Drug Administration through electronic means. 
‘‘(3) EXCEPTION.—The Secretary may waive requirements 
under this subsection if— 
‘‘(A) a new methodology or methodologies have been 
developed and validated but a laboratory has not yet been 
accredited to perform such methodology or methodologies; 
and 
‘‘(B) the use of such methodology or methodologies 
are necessary to prevent, control, or mitigate a food emer-
gency or foodborne illness outbreak. 
‘‘(c) REVIEW BY SECRETARY.—If food sampling and testing per-
formed by a laboratory run and operated by a State or locality 
that is accredited by a recognized accreditation body on the registry 
established by the Secretary under subsection (a) result in a State 
recalling a food, the Secretary shall review the sampling and testing
H. R. 2751—45 
results for the purpose of determining the need for a national 
recall or other compliance and enforcement activities. 
‘‘(d) NO LIMIT ON SECRETARIAL AUTHORITY.—Nothing in this 
section shall be construed to limit the ability of the Secretary 
to review and act upon information from food testing, including 
determining the sufficiency of such information and testing.’’. 
(b) FOOD EMERGENCY RESPONSE NETWORK.—The Secretary, in 
coordination with the Secretary of Agriculture, the Secretary of 
Homeland Security, and State, local, and tribal governments shall, 
not later than 180 days after the date of enactment of this Act, 
and biennially thereafter, submit to the relevant committees of 
Congress, and make publicly available on the Internet Web site 
of the Department of Health and Human Services, a report on 
the progress in implementing a national food emergency response 
laboratory network that— 
(1) provides ongoing surveillance, rapid detection, and surge 
capacity for large-scale food-related emergencies, including 
intentional adulteration of the food supply; 
(2) coordinates the food laboratory capacities of State, local, 
and tribal food laboratories, including the adoption of novel 
surveillance and identification technologies and the sharing 
of data between Federal agencies and State laboratories to 
develop national situational awareness; 
(3) provides accessible, timely, accurate, and consistent food 
laboratory services throughout the United States; 
(4) develops and implements a methods repository for use 
by Federal, State, and local officials; 
(5) responds to food-related emergencies; and 
(6) is integrated with relevant laboratory networks 
administered by other Federal agencies. 
SEC. 203. INTEGRATED CONSORTIUM OF LABORATORY NETWORKS. 
(a) IN GENERAL.—The Secretary of Homeland Security, in 
coordination with the Secretary of Health and Human Services, 
the Secretary of Agriculture, the Secretary of Commerce, and the 
Administrator of the Environmental Protection Agency, shall main-
tain an agreement through which relevant laboratory network mem-
bers, as determined by the Secretary of Homeland Security, shall— 
(1) agree on common laboratory methods in order to reduce 
the time required to detect and respond to foodborne illness 
outbreaks and facilitate the sharing of knowledge and informa-
tion relating to animal health, agriculture, and human health; 
(2) identify means by which laboratory network members 
could work cooperatively— 
(A) to optimize national laboratory preparedness; and 
(B) to provide surge capacity during emergencies; and 
(3) engage in ongoing dialogue and build relationships that 
will support a more effective and integrated response during 
emergencies. 
(b) REPORTING REQUIREMENT.—The Secretary of Homeland 
Security shall, on a biennial basis, submit to the relevant commit-
tees of Congress, and make publicly available on the Internet Web 
site of the Department of Homeland Security, a report on the 
progress of the integrated consortium of laboratory networks, as 
established under subsection (a), in carrying out this section.
H. R. 2751—46 
SEC. 204. ENHANCING TRACKING AND TRACING OF FOOD AND 
RECORDKEEPING. 
(a) PILOT PROJECTS.— 
(1) IN GENERAL.—Not later than 270 days after the date 
of enactment of this Act, the Secretary of Health and Human 
Services (referred to in this section as the ‘‘Secretary’’), taking 
into account recommendations from the Secretary of Agriculture 
and representatives of State departments of health and agri-
culture, shall establish pilot projects in coordination with the 
food industry to explore and evaluate methods to rapidly and 
effectively identify recipients of food to prevent or mitigate 
a foodborne illness outbreak and to address credible threats 
of serious adverse health consequences or death to humans 
or animals as a result of such food being adulterated under 
section 402 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 342) or misbranded under section 403(w) of such Act 
(21 U.S.C. 343(w)). 
(2) CONTENT.—The Secretary shall conduct 1 or more pilot 
projects under paragraph (1) in coordination with the processed 
food sector and 1 or more such pilot projects in coordination 
with processors or distributors of fruits and vegetables that 
are raw agricultural commodities. The Secretary shall ensure 
that the pilot projects under paragraph (1) reflect the diversity 
of the food supply and include at least 3 different types of 
foods that have been the subject of significant outbreaks during 
the 5-year period preceding the date of enactment of this Act, 
and are selected in order to— 
(A) develop and demonstrate methods for rapid and 
effective tracking and tracing of foods in a manner that 
is practicable for facilities of varying sizes, including small 
businesses; 
(B) develop and demonstrate appropriate technologies, 
including technologies existing on the date of enactment 
of this Act, that enhance the tracking and tracing of food; 
and 
(C) inform the promulgation of regulations under sub-
section (d). 
(3) REPORT.—Not later than 18 months after the date of 
enactment of this Act, the Secretary shall report to Congress 
on the findings of the pilot projects under this subsection 
together with recommendations for improving the tracking and 
tracing of food. 
(b) ADDITIONAL DATA GATHERING.— 
(1) IN GENERAL.—The Secretary, in coordination with the 
Secretary of Agriculture and multiple representatives of State 
departments of health and agriculture, shall assess— 
(A) the costs and benefits associated with the adoption 
and use of several product tracing technologies, including 
technologies used in the pilot projects under subsection 
(a); 
(B) the feasibility of such technologies for different 
sectors of the food industry, including small businesses; 
and 
(C) whether such technologies are compatible with the 
requirements of this subsection. 
(2) REQUIREMENTS.—To the extent practicable, in carrying 
out paragraph (1), the Secretary shall—
H. R. 2751—47 
(A) evaluate domestic and international product tracing 
practices in commercial use; 
(B) consider international efforts, including an assess-
ment of whether product tracing requirements developed 
under this section are compatible with global tracing sys-
tems, as appropriate; and 
(C) consult with a diverse and broad range of experts 
and stakeholders, including representatives of the food 
industry, agricultural producers, and nongovernmental 
organizations that represent the interests of consumers. 
(c) PRODUCT TRACING SYSTEM.—The Secretary, in consultation 
with the Secretary of Agriculture, shall, as appropriate, establish 
within the Food and Drug Administration a product tracing system 
to receive information that improves the capacity of the Secretary 
to effectively and rapidly track and trace food that is in the United 
States or offered for import into the United States. Prior to the 
establishment of such product tracing system, the Secretary shall 
examine the results of applicable pilot projects and shall ensure 
that the activities of such system are adequately supported by 
the results of such pilot projects. 
(d) ADDITIONAL RECORDKEEPING REQUIREMENTS FOR HIGH RISK 
FOODS.— 
(1) IN GENERAL.—In order to rapidly and effectively identify 
recipients of a food to prevent or mitigate a foodborne illness 
outbreak and to address credible threats of serious adverse 
health consequences or death to humans or animals as a result 
of such food being adulterated under section 402 of the Federal 
Food, Drug, and Cosmetic Act or misbranded under section 
403(w) of such Act, not later than 2 years after the date 
of enactment of this Act, the Secretary shall publish a notice 
of proposed rulemaking to establish recordkeeping require-
ments, in addition to the requirements under section 414 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350c) 
and subpart J of part 1 of title 21, Code of Federal Regulations 
(or any successor regulations), for facilities that manufacture, 
process, pack, or hold foods that the Secretary designates under 
paragraph (2) as high-risk foods. The Secretary shall set an 
appropriate effective date of such additional requirements for 
foods designated as high risk that takes into account the length 
of time necessary to comply with such requirements. Such 
requirements shall— 
(A) relate only to information that is reasonably avail-
able and appropriate; 
(B) be science-based; 
(C) not prescribe specific technologies for the mainte-
nance of records; 
(D) ensure that the public health benefits of imposing 
additional recordkeeping requirements outweigh the cost 
of compliance with such requirements; 
(E) be scale-appropriate and practicable for facilities 
of varying sizes and capabilities with respect to costs and 
recordkeeping burdens, and not require the creation and 
maintenance of duplicate records where the information 
is contained in other company records kept in the normal 
course of business;