117 
$6,436,000 shall remain available until September 30, 
2015; ‘‘Botanic Garden’’, $13,834,000, of which $1,505,000 
shall remain available until September 30, 2015; and ‘‘Cap-
itol Visitor Center’’, $22,771,000. In addition, notwith-
standing section 1101, $40,000,000, to remain available 
until expended, shall be available under ‘‘Architect of the 
Capitol, House Office Buildings’’ for a payment to the 
House Historic Buildings Revitalization Trust Fund. 
SEC. 2908. (a) Notwithstanding section 1101, the level 
for ‘‘Government Accountability Office, Salaries and Ex-
penses’’ shall be $558,430,000. 
(b) Notwithstanding section 1101, the amount applica-
ble under the first proviso under the heading ‘‘Government 
Accountability Office, Salaries and Expenses’’ in the Legis-
lative Branch Appropriations Act, 2010 (Public Law 111– 
68) shall be $9,400,000, the amount applicable under the 
second proviso under such heading shall be $3,100,000, and 
the amount applicable under the third proviso under such 
heading shall be $7,000,000. 
CHAPTER 10—MILITARY CONSTRUCTION, 
VETERANS AFFAIRS, AND RELATED AGENCIES 
SEC. 3001. Notwithstanding section 1101, the level for 
each of the following accounts of the Department of Defense 
for projects and activities included in the most recently sub-
mitted future years defense program or that are necessary
118 
to support overseas contingency operations shall be as fol-
lows: ‘‘Military Construction, Army’’, $4,885,000,000; 
‘‘Military Construction, Navy and Marine Corps’’, 
$3,517,000,000; 
‘‘Military 
Construction, 
Air 
Force’’, 
$1,592,000,000; ‘‘Military Construction, Defense-Wide’’, 
$3,095,000,000; ‘‘Military Construction, Army National 
Guard’’, $874,000,000; ‘‘Military Construction, Air Na-
tional Guard’’, $177,000,000; ‘‘Military Construction, 
Army Reserve’’, $318,000,000; ‘‘Military Construction, 
Navy Reserve’’, $62,000,000; ‘‘Military Construction, Air 
Force Reserve’’, $8,000,000; ‘‘Family Housing Construc-
tion, Army’’, $92,000,000; ‘‘Family Housing Construction, 
Navy and Marine Corps’’, $186,000,000; ‘‘Family Housing 
Construction, Air Force’’, $78,000,000; and ‘‘Family Hous-
ing Construction, Defense-Wide’’, $0. Within 45 days of the 
enactment of this section, the Department of Defense shall 
submit a project-level expenditure plan for fiscal year 2011 
for the accounts funded in this section. 
SEC. 3002. Notwithstanding section 1111, of the total 
amount specified in section 3001 for ‘‘Military Construc-
tion, Army’’, ‘‘Military Construction, Air Force’’, and 
‘‘Military Construction, Defense-Wide’’, $1,257,000,000 for 
Overseas Deployments and Other Activities is designated as 
an emergency requirement and necessary to meet emergency 
needs pursuant to sections 403(a) and 423(b) of S. Con.
119 
Res. 13 (111th Congress), the concurrent resolution on the 
budget for fiscal year 2010. 
SEC. 3003. Notwithstanding section 1101, the level for 
each of the following accounts of the Department of Defense 
for projects and activities authorized by law shall be as fol-
lows: ‘‘North Atlantic Treaty Organization Security Invest-
ment Program’’, $259,000,000; ‘‘Homeowners Assistance 
Fund’’, $17,000,000; ‘‘Chemical Demilitarization Construc-
tion, Defense-Wide’’, $125,000,000; ‘‘Department of Defense 
Base Closure Account 1990’’, $360,000,000; and ‘‘Depart-
ment 
of 
Defense 
Base 
Closure 
Account 
2005’’, 
$2,354,000,000. 
SEC. 3004. Notwithstanding any other provision of 
this Act, the following provisions included in title I of divi-
sion E of Public Law 111–117 shall not apply to funds 
appropriated by this Act: the first, second, and last pro-
visos, and the set-aside of $350,000,000, under the heading 
‘‘Military Construction, Army’’; the first and last provisos 
under the heading ‘‘Military Construction, Navy and Ma-
rine Corps’’; the first, second, and last provisos under the 
heading ‘‘Military Construction, Air Force’’; the second, 
third, fourth, and last provisos under the heading ‘‘Military 
Construction, Defense-Wide’’; the first, second, and last pro-
visos, and the set-aside of $30,000,000, under the heading 
‘‘Military Construction, Army National Guard’’; the first,
120 
second, and last provisos, and the set-aside of $30,000,000, 
under the heading ‘‘Military Construction, Air National 
Guard’’; the first, second, and last provisos, and the set- 
aside of $30,000,000, under the heading ‘‘Military Con-
struction, Army Reserve’’; the first, second, and last pro-
visos, the set-aside of $20,000,000, and the set-aside of 
$35,000,000, under the heading ‘‘Military Construction, 
Navy Reserve’’; the first, second, and last provisos, and the 
set-aside of $55,000,000, under the heading ‘‘Military Con-
struction, Air Force Reserve’’; the proviso under the heading 
‘‘Family Housing Construction, Army’’; the proviso under 
the heading ‘‘Family Housing Construction, Navy and Ma-
rine Corps’’; the proviso under the heading ‘‘Family Hous-
ing Construction, Air Force’’; the proviso under the heading 
‘‘Family Housing Construction, Defense-Wide’’; and the 
proviso under the heading ‘‘Chemical Demilitarization 
Construction, Defense-Wide’’. 
SEC. 3005. Section 129 of division E of Public Law 
111–117 shall not apply in fiscal year 2011. 
SEC. 3006. Notwithstanding any other provision of 
this Act, the following provisions included in title IV of di-
vision E of Public Law 111–117 shall not apply to funds 
appropriated by this Act: the proviso under ‘‘Military Con-
struction, Army’’; and the proviso under ‘‘Military Con-
struction, Air Force’’.
121 
SEC. 3007. Notwithstanding any other provision of 
law, funds made available to the Department of Defense by 
this chapter may be obligated and expended to carry out 
planning and design and military construction projects not 
otherwise authorized by law. 
SEC. 3008. Notwithstanding any other provision of 
law, funds made available to ‘‘North Atlantic Treaty Orga-
nization Security Investment Program’’ by this chapter 
may be obligated and expended for purposes of section 2806 
of title 10, United States Code, and sections 2501 and 2502 
of the National Defense Authorization Act for Fiscal Year 
2010 (Public Law 111–84). 
SEC. 3009. Notwithstanding section 1101, the level for 
‘‘Department of Veterans Affairs, Departmental Adminis-
tration, 
General 
Operating 
Expenses’’ 
shall 
be 
$2,546,276,000, of which not less than $2,148,776,000 shall 
be for the Veterans Benefits Administration. 
SEC. 3010. Notwithstanding section 1101, the level for 
‘‘Department of Veterans Affairs, Departmental Adminis-
tration, 
Information 
Technology 
Systems’’ 
shall 
be 
$3,162,501,000. 
SEC. 3011. Notwithstanding section 1101, the level for 
‘‘Department of Veterans Affairs, Departmental Adminis-
tration, 
Construction, 
Major 
Projects’’ 
shall 
be 
$1,151,036,000. Within 30 days of the enactment of this sec-
122 
tion, the Department shall submit to the Committees on Ap-
propriations of the House of Representatives and the Senate 
a spending plan for fiscal year 2011 at a level of detail 
below the account level. 
SEC. 3012. Notwithstanding section 1101, the level for 
‘‘Department of Veterans Affairs, Departmental Adminis-
tration, 
Construction, 
Minor 
Projects’’ 
shall 
be 
$467,700,000. 
SEC. 3013. Notwithstanding section 1101, the level for 
‘‘Department of Veterans Affairs, Departmental Adminis-
tration, Grants for Construction of State Extended Care 
Facilities’’ shall be $85,000,000. 
SEC. 3014. Notwithstanding any other provision in 
this Act, sections 230, 231, and 232 of division E of Public 
Law 111–117 shall not apply in fiscal year 2011. 
SEC. 3015. Notwithstanding section 1101, the level for 
‘‘Department of Defense—Civil, Cemeterial Expenses, 
Army, Salaries and Expenses’’, shall be $50,340,000. 
SEC. 3016. Notwithstanding section 1101, the level for 
‘‘Armed Forces Retirement Home, Trust Fund’’, shall be 
$71,200,000, of which $2,000,000 shall be for renovation of 
physical plants. 
SEC. 3017. (a) Of the funds appropriated in division 
E of Public Law 111–117, the following amounts which be-
came available on October 1, 2010, are hereby rescinded
123 
from the following accounts of the Department of Veterans 
Affairs in the amounts specified: ‘‘Medical services’’, 
$1,015,000,000; 
‘‘Medical 
support 
and 
compliance’’, 
$145,000,000; and ‘‘Medical facilities’’, $145,000,000. 
(b) An additional amount is appropriated to the fol-
lowing accounts of the Department of Veterans Affairs in 
the amounts specified, to remain available until September 
30, 2012: ‘‘Medical services’’, $1,015,000,000; ‘‘Medical sup-
port and compliance’’, $145,000,000; and ‘‘Medical facili-
ties’’, $145,000,000. 
SEC. 3018. Amounts provided to the Department of 
Veterans Affairs for ‘‘Medical services’’, ‘‘Medical support 
and compliance’’, ‘‘Medical facilities’’, ‘‘Construction, 
minor projects’’, and ‘‘Information technology systems’’ for 
fiscal year 2011 shall be available, through the date speci-
fied by section 1106 of this Act: (1) for transfer to the Joint 
Department of Defense-Department of Veterans Affairs 
Medical Facility Demonstration Fund, established by sec-
tion 1704 of Public Law 111–84, and (2) for operations 
of the integrated Captain James A. Lovell Federal Health 
Care Center, consisting of the North Chicago Veteran Af-
fairs Medical Center, and Navy Ambulatory Care Center, 
and supporting facilities designated as a combined Federal 
medical facility as described by section 706 of Public Law 
110–417.
124 
SEC. 3019. Such sums as may be deposited to the Med-
ical Care Collections Fund pursuant to section 1729A of 
title 38, United States Code, for health care provided at 
the Captain James A. Lovell Federal Health Care Center 
shall also be available: (1) for transfer to the Joint Depart-
ment of Defense-Department of Veterans Affairs Medical 
Facility Demonstration Fund, established by section 1704 
of Public Law 111–84, and (2) for operations of the inte-
grated Captain James A. Lovell Federal Health Care Cen-
ter, consisting of the North Chicago Veteran Affairs Medical 
Center and Navy Ambulatory Care Center, and supporting 
facilities designated as a combined Federal medical facility 
as described by section 706 of Public Law 110–417. 
CHAPTER 11—STATE, FOREIGN OPERATIONS, 
AND RELATED PROGRAMS 
SEC. 3101. For purposes of this chapter, the term ‘‘di-
vision F of Public Law 111–117’’ means the Department 
of State, Foreign Operations, and Related Programs Appro-
priations Act, 2010 (division F of Public Law 111–117). 
SEC. 3102. Notwithstanding section 1101, the level for 
each of the following accounts shall be as follows: ‘‘Adminis-
tration of Foreign Affairs, Diplomatic and Consular Pro-
grams’’, $8,971,529,000; ‘‘Administration of Foreign Af-
fairs, Civilian Stabilization Initiative’’, $35,000,000; 
‘‘International Organizations, Contributions to Inter-
125 
national Organizations’’, $1,575,430,000; ‘‘International 
Organizations, Contributions for International Peace-
keeping Activities’’, $2,105,000,000; ‘‘International Com-
missions, International Boundary and Water Commission, 
United States and Mexico, Construction’’, $26,900,000; 
‘‘International Commissions, International Fisheries Com-
missions’’, $51,000,000; ‘‘Related Agency, Broadcasting 
Board of Governors, Broadcasting Capital Improvements’’, 
$6,875,000; ‘‘Related Programs, United States Institute of 
Peace’’, $44,050,000, which shall not be used for construc-
tion activities; ‘‘United States Agency for International De-
velopment, Funds Appropriated to the President, Civilian 
Stabilization Initiative’’, $15,000,000; ‘‘United States 
Agency for International Development, Funds Appro-
priated to the President, Capital Investment Fund’’, 
$173,000,000; ‘‘Bilateral Economic Assistance, Funds Ap-
propriated to the President, International Fund for Ire-
land’’, $15,000,000; ‘‘Bilateral Economic Assistance, Funds 
Appropriated 
to 
the 
President, 
Democracy 
Fund’’, 
$115,000,000, of which $68,500,000 shall be made available 
for the Human Rights and Democracy Fund of the Bureau 
of Democracy, Human Rights and Labor, Department of 
State, and $46,500,000 shall be made available for the Of-
fice of Democracy and Governance of the Bureau for Democ-
racy, Conflict, and Humanitarian Assistance, United
126 
States Agency for International Development; ‘‘Bilateral 
Economic Assistance, Funds Appropriated to the President, 
Assistance for Europe, Eurasia and Central Asia’’, 
$709,000,000; ‘‘Bilateral Economic Assistance, Department 
of the Treasury, Debt Restructuring’’, $56,000,000; ‘‘Multi-
lateral Assistance, Funds Appropriated to the President, 
International Development Association’’, $1,235,000,000; 
‘‘Multilateral Assistance, Funds Appropriated to the Presi-
dent, Contribution to the Inter-American Development 
Bank’’, $21,000,000; ‘‘Multilateral Assistance, Funds Ap-
propriated to the President, Contribution to the African De-
velopment Fund’’, $150,000,000; ‘‘International Security 
Assistance, Department of State, Nonproliferation, Anti- 
terrorism, 
Demining 
and 
Related 
Programs’’, 
$740,000,000; ‘‘International Security Assistance, Depart-
ment of State, Peacekeeping Operations’’, $305,000,000; 
‘‘International Security Assistance, Funds Appropriated to 
the President, International Military Education and 
Training’’, $107,000,000; ‘‘International Security Assist-
ance, Funds Appropriated to the President, Pakistan Coun-
terinsurgency Capability Fund’’, $700,000,000, which shall 
remain available until September 30, 2012, and shall be 
available to the Secretary of State under the terms and con-
ditions provided for this Fund in Public Law 111–32 and 
Public Law 111–212; and ‘‘International Security Assist-
127 
ance, Funds Appropriated to the President, Foreign Mili-
tary Financing Program’’, $5,440,000,000, of which not less 
than $3,000,000,000 shall be available for grants only for 
Israel and $1,300,000,000 shall be available for grants only 
for Egypt and $300,000,000 shall be available for assistance 
for Jordan: Provided, That the dollar amount in the fourth 
proviso under the heading ‘‘International Security Assist-
ance, Funds Appropriated to the President, Foreign Mili-
tary Financing Program’’ in division F of Public Law 
111–117 shall be deemed to be $789,000,000 for the purpose 
of applying funds appropriated under such heading by this 
Act. 
SEC. 3103. Notwithstanding section 1101, the dollar 
amount in the seventh proviso under the heading ‘‘Bilateral 
Economic Assistance, Funds Appropriated to the President, 
Economic Support Fund’’ in division F of Public Law 
111–117 shall be deemed to be $200,000,000 for the purpose 
of applying funds appropriated under such heading by this 
Act: Provided, That the ninth through the fourteenth pro-
visos under the heading ‘‘Bilateral Economic Assistance, 
Funds Appropriated to the President, Economic Support 
Fund’’ in division F of Public Law 111–117 shall not apply 
to assistance for Afghanistan under this Act: Provided fur-
ther, That the dollar amount in section 7042(f)(1) in divi-
128 
sion F of Public Law 111–117 shall be deemed to be 
$550,400,000. 
SEC. 3104. Notwithstanding section 1101, the level for 
each of the following accounts shall be $0: ‘‘Administration 
of Foreign Affairs, Buying Power Maintenance Account’’ 
and ‘‘Multilateral Assistance, Funds Appropriated to the 
President, Contribution to the Asian Development Fund’’. 
SEC. 3105. (a) In addition to amounts otherwise made 
available in this Act, $12,000,000 is appropriated for ‘‘Bi-
lateral Economic Assistance, Funds Appropriated to the 
President, Economic Support Fund’’ for activities specified 
in section 7071(j) of division F of Public Law 111–117. 
(b) For purposes of the amount made available by this 
Act for ‘‘Export-Import Bank of the United States, Admin-
istrative Expenses’’, project specific transaction costs, in-
cluding direct and indirect costs incurred in claims settle-
ments, and other costs for systems infrastructure directly 
supporting transactions, shall not be considered adminis-
trative expenses. 
(c) Of the unobligated balances available from funds 
appropriated under the heading ‘‘Export and Investment 
Assistance, Export-Import Bank of the United States, Sub-
sidy Appropriation’’ in the Department of State, Foreign 
Operations, and Related Programs Appropriations Act, 
2009 (division H, Public Law 111–8) and under such head-
129 
ing in prior Acts making appropriations for the Depart-
ment of State, foreign operations, and related programs, 
$160,000,000 is rescinded. 
SEC. 3106. (a) Notwithstanding any other provision 
of this Act, the dollar amounts under paragraphs (1) 
through (4) under the heading ‘‘Administration of Foreign 
Affairs, Diplomatic and Consular Programs’’ in division 
F of Public Law 111–117 shall not apply to funds appro-
priated by this Act: Provided, That the dollar amounts to 
be derived from fees collected under paragraph (5)(A) under 
such heading shall be ‘‘$1,702,904’’ and ‘‘$505,000’’, respec-
tively. 
(b) Notwithstanding any other provision of this Act, 
the following provisions in division F of Public Law 111– 
117 shall not apply to funds appropriated by this Act: 
(1) Section 7034(l). 
(2) Section 7042(a), (b)(1), (c), and (d)(1). 
(3) In section 7045: 
(A) The first sentence of subsection (c). 
(B) The first sentence of subsection (e)(1). 
(C) The first sentence of subsection (f). 
(D) Subsection (h). 
(4) Section 7070(b).
130 
(5) The third proviso under the heading ‘‘Ad-
ministration of Foreign Affairs, Civilian Stabiliza-
tion Initiative’’. 
(6) The fourth proviso under the heading ‘‘Bilat-
eral Economic Assistance, Funds Appropriated to the 
President, Assistance for Europe, Eurasia and Cen-
tral Asia’’. 
SEC. 3107. (a) Section 1115(d) of Public Law 111– 
32 is amended by striking ‘‘October 1, 2010’’ and inserting 
‘‘October 1, 2011’’. 
(b) Section 824(g)(2)(A) of the Foreign Service Act of 
1980 (22 U.S.C. 4064(g)(2)(A)) is amended by striking 
‘‘October 1, 2010’’ and inserting ‘‘October 1, 2011’’. 
(c) Section 61(a)(2) of the State Department Basic Au-
thorities Act of 1956 (22 U.S.C. 2733(a)(2)) is amended by 
striking ‘‘October 1, 2010’’ and inserting ‘‘October 1, 2011’’. 
(d) Section 625(j)(1)(B) of the Foreign Assistance Act 
of 1961 (22 U.S.C. 2385(j)(1)(B)) is amended by striking 
‘‘October 1, 2010’’ and inserting ‘‘October 1, 2011’’. 
(e) Section 1(b)(2) of the Passport Act of June 4, 1920 
(22 U.S.C. 214(b)(2)) is amended by striking ‘‘September 
30, 2010’’ and inserting ‘‘September 30, 2011’’. 
(f) The authority provided by section 1334 of the For-
eign Affairs Reform and Restructuring Act of 1998 (22
131 
U.S.C. 6553) shall remain in effect until September 30, 
2011. 
(g) Section 404(b)(2)(B)(vi) of the Foreign Relations 
Authorization Act, Fiscal Years 1994 and 1995 (22 U.S.C. 
287e note) is amended by striking ‘‘calendar year 2010,’’ 
and inserting ‘‘calendar years 2010 and 2011,’’. 
(h) The Foreign Operations, Export Financing, and 
Related Programs Appropriations Act, 1990 (Public Law 
101–167) is amended— 
(1) in section 599D (8 U.S.C. 1157 note)— 
(A) in subsection (b)(3), by striking ‘‘and 
2010’’ and inserting ‘‘2010, and 2011’’; and 
(B) in subsection (e), by striking ‘‘2010’’ 
each place it appears and inserting ‘‘2011’’; and 
(2) in section 599E (8 U.S.C. 1255 note) in sub-
section (b)(2), by striking ‘‘2010’’ and inserting 
‘‘2011’’. 
SEC. 3108. (a) The second proviso under the heading 
‘‘International Security Assistance, Department of State, 
Peacekeeping Operations’’ in division F of Public Law 
111–117 shall be applied by substituting the following: 
‘‘Provided further, That up to $55,918,000 may be used to 
pay assessed expenses of international peacekeeping activi-
ties in Somalia, except that up to an additional 
$35,000,000 may be made available for such purpose subject
133 
$36,000,000 may be made available for the United 
States share of an increase in the resources of the 
Fund for Special Operations of the Inter-American 
Development Bank in furtherance of providing debt 
relief to Haiti in view of the Cancun Declaration of 
March 21, 2010.’’. 
(e)(1) Section 7046(a) of division F of Public Law 
111–117 shall be applied to funds appropriated by this Act 
by substituting ‘‘$453,995,000’’ for the dollar amount. 
(2) The dollar amount in the sixteenth proviso under 
the heading ‘‘Bilateral Economic Assistance, Funds Appro-
priated to the President, Economic Support Fund’’ in divi-
sion F of Public Law 111–117 shall be deemed to be 
‘‘$195,000,000’’. 
(3) The dollar amount in the seventh proviso of the 
first paragraph under the heading ‘‘International Security 
Assistance, Funds Appropriated to the President, Foreign 
Military Financing Program’’ in division F of Public Law 
111–117 shall be deemed to be ‘‘$44,500,000’’ for the pur-
pose of applying funds appropriated under such headings 
by this Act. 
(f) The second proviso of section 7081(d) of division 
F of Public Law 111–117 is amended to read as follows: 
‘‘: Provided further, That funds appropriated under title 
III of this Act for tropical forest programs shall be used
134 
for purposes including to implement and enforce section 
8204 of Public Law 110–246, shall not be used to support 
or promote the expansion of industrial scale logging into 
primary tropical forests, and shall be subject to prior con-
sultation with, and the regular notification procedures of, 
the Committees on Appropriations’’. 
SEC. 3109. (a) Subsections (b) through (e) of this sec-
tion shall apply to funds appropriated by this Act in lieu 
of section 7076 of division F of Public Law 111–117. 
(b) LIMITATION.—None of the funds appropriated or 
otherwise made available by this Act under the headings 
‘‘Economic Support Fund’’ and ‘‘International Narcotics 
Control and Law Enforcement’’ may be obligated for assist-
ance for Afghanistan until the Secretary of State, in con-
sultation with the Administrator of the United States Agen-
cy for International Development (USAID), certifies and 
reports to the Committees on Appropriations that— 
(1) The Government of Afghanistan is— 
(A) demonstrating a commitment to reduce 
corruption and improve governance, including 
by investigating, prosecuting, sanctioning and/or 
removing corrupt officials from office and to im-
plement financial transparency and account-
ability measures for government institutions and
135 
officials (including the Central Bank) as well as 
to conduct oversight of public resources; 
(B) taking significant steps to facilitate ac-
tive public participation in governance and 
oversight; and 
(C) taking credible steps to protect the 
internationally recognized human rights of Af-
ghan women. 
(2) There is a unified United States Government 
anti-corruption strategy for Afghanistan that is ade-
quately funded, and is being implemented in conjunc-
tion with relevant Afghan authorities. 
(3) Funds will be programmed to support and 
strengthen the capacity of Afghan public and private 
institutions and entities to reduce corruption and to 
improve transparency and accountability of national, 
provincial and local governments, such as— 
(A) the High Office of Oversight; 
(B) the Control and Audit Office; 
(C) the Afghan Criminal Justice Task 
Force; 
(D) the Afghan Judicial Security Unit; 
(E) the Anti-Corruption Tribunal, and the 
Attorney General’s Anti-Corruption Unit;
136 
(F) the training and mentoring of judicial 
personnel; 
(G) the training and mentoring of Afghan 
Government personnel in financial management, 
budgeting, and independent oversight of public 
funds; and 
(H) Afghan civil society organizations and 
media institutions that play an important role 
in government oversight. 
(4) Representatives of Afghan national, provin-
cial or local governments, local communities and civil 
society organizations, as appropriate, will be con-
sulted and participate in the design of programs, 
projects, and activities, including participation in 
implementation and oversight, and the development of 
specific benchmarks to measure progress and out-
comes. 
(5) Funds will be used to train and deploy addi-
tional United States Government direct-hire per-
sonnel to improve monitoring and control of assist-
ance to ensure that funds are used for the intended 
purpose and do not support illicit and/or corrupt ac-
tivities. 
(6) A framework and methodology is being uti-
lized to assess national, provincial, local and sector
137 
level fiduciary risks relating to public financial man-
agement of United States Government assistance. 
(c) DIRECT GOVERNMENT-TO-GOVERNMENT ASSIST-
ANCE.— 
(1) Funds appropriated or otherwise made avail-
able by this Act for assistance for Afghanistan may 
not be made available for direct government-to-gov-
ernment assistance unless the Secretary of State cer-
tifies to the Committees on Appropriations that the 
relevant Afghan implementing agency has been as-
sessed and considered qualified to manage such funds 
and the Government of the United States and the 
Government of Afghanistan have agreed, in writing, 
to clear and achievable goals and objectives for the use 
of such funds, and have established mechanisms with-
in each implementing agency to ensure that such 
funds are used for the purposes for which they were 
intended: Provided, That the Secretary of State 
should suspend any direct government-to-government 
assistance to an implementing agency if the Secretary 
has credible information of misuse of such funds by 
any such agency: Provided further, That any such as-
sistance shall be subject to prior consultation with, 
and the regular notification procedures of, the Com-
mittees on Appropriations.
138 
(2) Funds appropriated or otherwise made avail-
able by this Act for assistance for Afghanistan may 
be made available as a United States contribution to 
the Afghanistan Reconstruction Trust Fund (ARTF) 
unless the Secretary of State determines and reports 
to the Committees on Appropriations that the World 
Bank Monitoring Agent of the ARTF is unable to 
conduct its financial control and audit responsibil-
ities due to restrictions on security personnel by the 
Government of Afghanistan. 
(d) ASSISTANCE FOR OPERATIONS.— 
(1) Funds appropriated under the headings 
‘‘Economic Support Fund’’ and ‘‘International Nar-
cotics Control and Law Enforcement’’ in this Act that 
are available for assistance for Afghanistan— 
(A) shall be made available, to the max-
imum extent practicable, in a manner that em-
phasizes the participation of Afghan women, and 
directly improves the security, economic and so-
cial well-being, and political status, and protects 
the rights of, Afghan women and girls and com-
plies with sections 7062 and 7063 of division F 
of Public Law 111–117, including support for 
the Afghan Independent Human Rights Commis-
139 
sion, the Afghan Ministry of Women’s Affairs, 
and women-led nongovernmental organizations; 
(B) may be made available for a United 
States contribution to an internationally-man-
aged fund to support the reconciliation with and 
disarmament, demobilization and reintegration 
into Afghan society of former combatants who 
have renounced violence against the Government 
of Afghanistan: Provided, That funds may be 
made available to support reconciliation and re-
integration activities only if— 
(i) Afghan women are participating at 
national, provincial and local levels of gov-
ernment in the design, policy formulation 
and implementation of the reconciliation or 
reintegration process, and such process up-
holds steps taken by the Government of Af-
ghanistan to protect the internationally rec-
ognized human rights of Afghan women; 
and 
(ii) such funds will not be used to sup-
port any pardon or immunity from pros-
ecution, or any position in the Government 
of Afghanistan or security forces, for any 
leader of an armed group responsible for
140 
crimes against humanity, war crimes, or 
other violations of internationally recog-
nized human rights. 
(C) may be made available for a United 
States contribution to the North Atlantic Treaty 
Organization/International Security Assistance 
Force Post-Operations Humanitarian Relief 
Fund; and 
(D) should be made available, notwith-
standing any provision of law that restricts as-
sistance to foreign countries, for cross border sta-
bilization and development programs between Af-
ghanistan and Pakistan or between either coun-
try and the Central Asian republics. 
(2) Programs and activities funded under titles 
III and IV of this Act that provide training for for-
eign police, judicial, and military personnel shall ad-
dress, where appropriate, gender-based violence. 
(3) The authority contained in section 1102(c) of 
Public Law 111–32 shall continue in effect during fis-
cal year 2011 and shall apply as if included in this 
Act. 
(4) The Coordinator for Rule of Law at the 
United States Embassy in Kabul, Afghanistan shall
141 
be consulted on the use of all funds appropriated by 
this Act for rule of law programs in Afghanistan. 
(5) None of the funds made available by this Act 
may be used by the United States Government to 
enter into a permanent basing rights agreement be-
tween the United States and Afghanistan. 
(6) The Secretary of State, after consultation 
with the USAID Administrator, shall submit to the 
Committees on Appropriations not later than 45 days 
after enactment of this Act, and prior to the initial 
obligation of funds, a detailed spending plan for as-
sistance for Afghanistan which shall include clear and 
achievable goals, benchmarks for measuring progress, 
and expected results: Provided, That such plan shall 
not be considered as meeting the notification require-
ments under section 7015 of division F of Public Law 
111–117 or under section 634A of the Foreign Assist-
ance Act of 1961. 
(7) Any significant modification to the scope, ob-
jectives, or implementation mechanisms of United 
States assistance programs in Afghanistan shall be 
subject to prior consultation with, and the regular no-
tification procedures of, the Committees on Appro-
priations, except that the prior consultation require-
142 
ment may be waived in a manner consistent with sec-
tion 7015(e) of division F of Public Law 111–117. 
(e) OVERSIGHT.— 
(1) The Special Inspector General for Afghani-
stan Reconstruction, the Inspector General of the De-
partment of State and the Inspector General of 
USAID, shall jointly develop and submit to the Com-
mittees on Appropriations within 45 days of enact-
ment of this Act a coordinated audit and inspection 
plan of United States assistance for, and civilian op-
erations in, Afghanistan. 
(2) Of the funds appropriated in this Act under 
the heading ‘‘Economic Support Fund’’ for assistance 
for Afghanistan, $3,000,000 shall be transferred to, 
and merged with, funds made available under the 
heading ‘‘Office of Inspector General’’ in title I of this 
Act, for increased oversight of programs in Afghani-
stan and shall be in addition to funds otherwise 
available 
for 
such 
purposes: 
Provided, 
That 
$1,500,000 shall be for the Special Inspector General 
for Afghanistan Reconstruction. 
(3) Of the funds appropriated in this Act under 
the heading ‘‘Economic Support Fund’’ for assistance 
for Afghanistan, $1,500,000 shall be transferred to, 
and merged with, funds appropriated under the head-
143 
ing ‘‘Office of Inspector General’’ in title II of this 
Act for increased oversight of programs in Afghani-
stan and shall be in addition to funds otherwise 
available for such purposes. 
(f) MODIFICATION TO PRIOR PROVISIONS.— 
(1) Section 1004(c)(1)(C) of Public Law 111– 
212 is amended to read as follows: 
‘‘(C) taking credible steps to protect the inter-
nationally recognized human rights of Afghan 
women.’’. 
(2) Section 1004(d)(l) of Public Law 111–212 is 
amended to read as follows: 
‘‘(1) Afghan women are participating at na-
tional, provincial and local levels of government in 
the design, policy formulation and implementation of 
the reconciliation or reintegration process, and such 
process upholds steps taken by the Government of Af-
ghanistan to protect the internationally recognized 
human rights of Afghan women; and’’. 
(3) Section 1004(e)(1) of Public Law 111–212 is 
amended to read as follows: 
‘‘(1) based on information available to the Sec-
retary, the Independent Electoral Commission has no 
members or other employees who participated in, or 
helped to cover up, acts of fraud in the 2009 presi-
144 
dential election in Afghanistan, and the Electoral 
Complaints Commission is a genuinely independent 
body with all the authorities that were invested in it 
under Afghan law as of December 31, 2009; and’’. 
SEC. 3110. In addition to amounts otherwise made 
available by this Act, $100,000,000, to remain available 
until expended, is appropriated for payment as a contribu-
tion to a global food security fund by the Secretary of the 
Treasury. 
SEC. 3111. (a) CONTRIBUTION TO THE ASIAN DEVEL-
OPMENT BANK.—In addition to amounts otherwise made 
available by this Act, $106,586,000, to remain available 
until expended, is appropriated for payment to the Asian 
Development Bank by the Secretary of the Treasury for the 
United States share of the paid-in portion of the increase 
in capital stock. 
(b) LIMITATION ON CALLABLE CAPITAL SUBSCRIP-
TIONS.—The United States Governor of the Asian Develop-
ment Bank may subscribe without fiscal year limitation to 
the callable capital portion of the United States share of 
such capital stock in an amount not to exceed 
$2,558,048,769. 
(c) AMENDMENT.—The Asian Development Bank Act 
(22 U.S.C. 285 et seq.), is amended by adding at the end 
the following:
145 
‘‘NINTH REPLENISHMENT 
‘‘SEC. 33. (a) The United States Governor of the Bank 
is authorized to contribute, on behalf of the United States, 
$461,000,000 to the ninth replenishment of the resources of 
the Fund, subject to obtaining the necessary appropriations. 
‘‘(b) In order to pay for the United States contribution 
provided for in subsection (a), there are authorized to be 
appropriated, without fiscal year limitation, $461,000,000 
for payment by the Secretary of the Treasury. 
‘‘FIFTH CAPITAL INCREASE 
‘‘SEC. 34. (a) Subscription Authorized. 
‘‘(1) The United States Governor of the Bank 
may subscribe on behalf of the United States to 
1,104,420 additional shares of the capital stock of the 
Bank. 
‘‘(2) Any subscription by the United States to 
capital stock of the Bank shall be effective only to 
such extent or in such amounts as are provided in ad-
vance in appropriations Acts. 
‘‘(b) Authorization of Appropriations— 
‘‘(1) In order to pay for the increase in the 
United States subscription to the Bank provided for 
in subsection (a), there are authorized to be appro-
priated, 
without 
fiscal 
year 
limitation, 
$13,323,173,083, for payment by the Secretary of the 
Treasury.
146 
‘‘(2) Of the amount authorized to be appro-
priated under paragraph (1)— 
‘‘(A) $532,929,240 is authorized to be ap-
propriated for paid in shares of the Bank; and 
‘‘(B) $12,790,243,843 is authorized to be 
appropriated for callable shares of the Bank, for 
payment by the Secretary of the Treasury.’’. 
CHAPTER 12—TRANSPORTATION, AND HOUSING 
AND URBAN DEVELOPMENT, AND RELATED 
AGENCIES 
SEC. 3201. Notwithstanding section 1101, the level for 
‘‘Department of Transportation, Federal Aviation Admin-
istration, Operations’’ shall be $9,542,983,000, of which 
$4,559,000,000 shall be derived from the Airport and Air-
way Trust Fund, of which no less than $7,473,299,000 shall 
be for air traffic organization activities; no less than 
$1,253,020,000 shall be for aviation regulation and certifi-
cation activities; not to exceed $15,237,000 shall be avail-
able for commercial space transportation activities; not to 
exceed $113,681,000 shall be available for financial services 
activities; not to exceed $100,428,000 shall be available for 
human resources program activities; not to exceed 
$341,977,000 shall be available for region and center oper-
ations and regional coordination activities; not to exceed 
$196,063,000 shall be available for staff offices; and not to
147 
exceed $49,278,000 shall be available for information serv-
ices. 
SEC. 3202. The amounts included under the heading 
‘‘Department of Transportation, Federal Aviation Admin-
istration, Grants-in-Aid for Airports (Liquidation of Con-
tract Authorization)’’ in division A of Public Law 111–117 
shall be applied to funds appropriated by this Act by sub-
stituting ‘‘$3,550,000,000’’ for ‘‘$3,000,000,000’’. 
SEC. 3203. Notwithstanding section 1101, the level for 
‘‘Department of Transportation, Federal Highway Admin-
istration, Surface Transportation Priorities’’ shall be $0. 
SEC. 3204. Notwithstanding section 1101, no funds are 
provided for activities described in section 122 of title I of 
division A of Public Law 111–117. 
SEC. 3205. Of the amount made available for ‘‘Depart-
ment of Transportation, Motor Carrier Safety Grants, (Liq-
uidation of Contract Authorization), (Limitation on Obli-
gations), (Highway Trust Fund)’’ for the commercial driv-
er’s license information system modernization program, 
$3,000,000 shall be made available for audits of new en-
trant motor carriers to carry out section 4107(b) of Public 
Law 109–59, and 31104(a) of title 49, United States Code, 
and $5,000,000 shall be made available for the commercial 
driver’s license improvements program to carry out section 
31313 of title 49, United States Code.
148 
SEC. 3206. Notwithstanding section 1101, the level for 
‘‘Department of Transportation, Federal Railroad Admin-
istration, Safety and Operations’’ shall be $176,950,000. 
SEC. 3207. Notwithstanding section 1101, the level for 
‘‘Department of Transportation, Federal Railroad Admin-
istration, Capital Assistance for High Speed Rail Corridors 
and 
Intercity 
Passenger 
Rail 
Service’’ 
shall 
be 
$1,000,000,000. 
SEC. 3208. Notwithstanding section 1101, the level for 
‘‘Department of Transportation, Maritime Administration, 
Operations and Training’’ shall be $155,750,000, of which 
$11,240,000 shall remain available until expended for 
maintenance and repair of training ships at State Mari-
time Academies, and of which $15,000,000 shall remain 
available until expended for capital improvements at the 
United States Merchant Marine Academy, of which 
$59,057,000 shall be available for operations at the United 
States Merchant Marine Academy, and of which $6,000,000 
shall remain available until expended for the Secretary’s 
reimbursement of overcharged midshipmen fees for aca-
demic years 2003–2004 through 2008–2009 and such action 
shall be final and conclusive. 
SEC. 3209. Notwithstanding section 1101, the level for 
each of the following accounts under the heading ‘‘Depart-
ment of Transportation, Pipeline and Hazardous Materials
149 
Safety Administration’’ shall be as follows: ‘‘Operational 
Expenses (Pipeline Safety Fund)’’, $21,496,000; ‘‘Haz-
ardous Materials Safety’’, $39,098,000, of which $1,699,000 
shall remain available until September 30, 2013; and 
‘‘Pipeline Safety (Pipeline Safety Fund) (Oil Spill Liabil-
ity Trust Fund)’’, $106,919,000, of which $18,905,000 shall 
be derived from the Oil Spill Liability Trust Fund and 
shall remain available until September 30, 2013, and of 
which $88,014,000 shall be derived from the Pipeline Safety 
Fund, of which $47,332,000 shall remain available until 
September 30, 2013. 
SEC. 3210. Notwithstanding section 1101, section 186 
of title I of division A of Public Law 111–117 shall not 
apply to fiscal year 2011. 
SEC. 3211. Notwithstanding section 1101, the level for 
‘‘Department of Housing and Urban Development, Per-
sonnel Compensation and Benefits, Housing’’ shall be 
$390,885,000. 
SEC. 3212. Notwithstanding section 1101, the level for 
‘‘Department of Housing and Urban Development, Per-
sonnel Compensation and Benefits, Office of the Govern-
ment National Mortgage Association’’ shall be $14,000,000. 
SEC. 3213. Notwithstanding section 1101, the level for 
‘‘Department of Housing and Urban Development, Public 
and Indian Housing, Tenant-Based Rental Assistance’’
150 
shall be $14,863,998,000, to remain available until ex-
pended, shall be available on October 1, 2010 (in addition 
to the $4,000,000,000 previously appropriated under such 
heading that will become available on October 1, 2010), and 
notwithstanding 
section 
1109, 
an 
additional 
$4,000,000,000, to remain available until expended, shall 
be available on October 1, 2011: Provided, That of the 
amounts available for such heading, $16,993,998,000 shall 
be for activities specified in paragraph: (1) and 
$145,000,000 shall be for activities specified in paragraph 
(2) under such heading of division A of Public Law 111– 
117: Provided further, That of the amounts made available 
for activities under paragraph; (2) under such heading of 
division A of Public Law 111–117, $25,000,000 shall be 
available to provide tenant protection assistance, not other-
wise provided under this paragraph, to residents residing 
in low-vacancy areas and who may have to pay rents great-
er than 30 percent of household income, as the result of: 
(1) the maturity of a HUD-insured, HUD-held or section 
202 loan that requires the permission of the Secretary prior 
to loan payment; (2) the expiration of a rental assistance 
contract for which the tenants are not eligible for enhanced 
voucher or tenant protection assistance under existing law; 
or (3) the expiration of affordability restrictions accom-
panying a mortgage or preservation program administered
151 
by the Secretary: Provided further, That such tenant protec-
tion assistance made available under the previous proviso 
may be provided under the authority of section 8(t) of the 
United States Housing Act of 1937 (42 U.S.C. 1937f(t)): 
Provided further, That the Secretary shall issue guidance 
to implement the previous two provisos, including but not 
limited to requirements for defining eligible at-risk house-
holds, within 120 days of the enactment of this Act. 
SEC. 3214. The seventh proviso in paragraph (1) 
under the heading ‘‘Department of Housing and Urban De-
velopment, Public and Indian Housing, Tenant-Based 
Rental Assistance’’ in division A of Public Law 111–117 
shall be applied in fiscal year 2011 by inserting before the 
colon at the end the following: ‘‘; (5) for one-time adjust-
ments of renewal funding for public housing agencies in re-
ceivership with approved fungibility plans for calendar 
year 2009 as authorized in section 11003 of the Consoli-
dated Security, Disaster Assistance, and Continuing Ap-
propriations Act, 2009 (Public Law 110–329); or (6) to ad-
just allocations for public housing agencies to prevent ter-
mination of assistance to families receiving assistance 
under the disaster voucher program, as authorized by chap-
ter 9 of title I of division B of Public Law 109–148 under 
the heading ‘Tenant-Based Rental Assistance’ ’’.
152 
SEC. 3215. Notwithstanding section 1101, the level for 
‘‘Department of Housing and Urban Development, Commu-
nity Planning and Development, Community Development 
Fund’’ shall be $4,255,000,000, of which $3,990,000,000 
shall be for carrying out the community development block 
grant program under title I of the Housing and Community 
Development Act of 1974, as amended: Provided, That none 
of the funds made available by this section for such account 
may be used for grants for the Economic Development Ini-
tiative or Neighborhood Initiatives activities. 
SEC. 3216. Notwithstanding section 1101, the level for 
‘‘Department of Housing and Urban Development, Commu-
nity Planning and Development, Homeless Assistance 
Grants’’ shall be $2,055,000,000. 
SEC. 3217. Notwithstanding section 1101, the level for 
‘‘Department of Housing and Urban Development, Housing 
Programs, Project-Based Rental Assistance’’ shall be 
$8,882,328,000, to remain available until expended, shall 
be available on October 1, 2010 (in addition to the 
$393,672,000 previously appropriated under such heading 
that became available on October 1, 2010), and, notwith-
standing section 1109, an additional $400,000,000, to re-
main available until expended, shall be available on October 
1, 2011: Provided, That of the amounts available for such 
heading, $8,950,000,000 shall be for activities specified in
153 
paragraph (1) under such heading of division A of Public 
Law 111–117 and $326,000,000 shall be available for ac-
tivities specified in paragraph (2) under such heading in 
such public law. 
SEC. 3218. Notwithstanding section 1101, the level for 
‘‘Department of Housing and Urban Development, Housing 
Programs, Energy Innovation Fund’’ shall be $0. 
SEC. 3219. The heading ‘‘Department of Housing and 
Urban Development, Housing Program, Other Assisted 
Housing Programs, Rental Housing Assistance’’ shall be 
applied by inserting ‘‘, or extensions of up to one year for 
expiring contracts,’’ after ‘‘for amendments to contracts’’. 
SEC. 3220. Notwithstanding section 1101, the level 
under the heading ‘‘Department of Housing and Urban De-
velopment, Housing Programs, Rent Supplement (Rescis-
sion)’’ shall be $40,060,000. 
SEC. 3221. Notwithstanding section 1101, the level for 
‘‘Department of Housing and Urban Development, Federal 
Housing Administration, Mutual Mortgage Insurance Pro-
gram Account’’ for administrative contract expenses shall 
be $221,125,000. 
SEC. 3222. The first proviso in the first paragraph 
under the heading ‘‘Department of Housing and Urban De-
velopment, Federal Housing Administration, General and 
Special Risk Program Account’’ in division A of Public
154 
Law 111–117 shall be applied in fiscal year 2011 by sub-
stituting ‘‘$20,000,000,000’’ for ‘‘$15,000,000,000’’. 
SEC. 3223. Notwithstanding section 1101, the level for 
‘‘Department of Housing and Urban Development, Manage-
ment and Administration, Working Capital Fund’’ shall be 
$228,500,000. 
SEC. 3224. Notwithstanding section 1101, the level for 
‘‘Related Agencies, National Railroad Passenger Corpora-
tion, Office of Inspector General, Salaries and Expenses’’ 
shall be $19,496,000. 
SEC. 3225. Notwithstanding section 1101, the level 
under the heading ‘‘Related Agencies, United States Inter-
agency Council on Homelessness, Operating Expenses’’ shall 
be $3,930,000. 
SEC. 3226. Section 209 of the McKinney-Vento Home-
less Assistance Act (42 U.S.C. 11319) is repealed. 
SEC. 3227. Unobligated balances of funds made avail-
able for obligation under 23 U.S.C. 320, section 147 of Pub-
lic Law 95–599, section 9(c) of Public Law 97–134, section 
149 of Public Law 100–17, and sections 1006, 1069, 1103, 
1104, 1105, 1106, 1107, 1108, 6005, 6015, and 6023 of Pub-
lic Law 102–240 are permanently rescinded. In addition, 
the unobligated balance available on September 30, 2011, 
under section 1602 of the Transportation Equity Act for 
the 21st Century (Public Law 105–178) for each project for
155 
which less than 10 percent of the amount authorized for 
such project under such section has been obligated is perma-
nently rescinded. In addition, of the amounts authorized 
for fiscal years 2005 through 2009 in section 1101(a)(16) 
of the Safe, Accountable, Flexible, Efficient Transportation 
Equity Act: A Legacy for Users (Public Law 109–59) to 
carry out the high priority projects program under section 
117 of title 23, United States Code, that are not allocated 
for projects described in section 1702 of such Act, 
$8,190,335 are permanently rescinded. 
DIVISION B—SURFACE 
TRANSPORTATION EXTENSION 
SEC. 4001. SHORT TITLE; RECONCILIATION OF FUNDS. 
(a) SHORT TITLE.—This division may be cited as the 
‘‘Surface Transportation Extension Act of 2010, Part II’’. 
(b) RECONCILIATION OF FUNDS.—The Secretary of 
Transportation shall reduce the amount apportioned or al-
located for a program, project, or activity under this divi-
sion in fiscal year 2011 by amounts apportioned or allo-
cated pursuant to the Surface Transportation Extension 
Act of 2010 for the period beginning on October 1, 2010, 
and ending on December 31, 2010.
156 
TITLE I—FEDERAL-AID 
HIGHWAYS 
SEC. 4101. EXTENSION OF FEDERAL-AID HIGHWAY PRO-
GRAMS. 
(a) IN GENERAL.—Section 411 of the Surface Trans-
portation Extension Act of 2010 (Public Law 111–147; 124 
Stat. 78) is amended— 
(1) by striking ‘‘the period beginning on October 
1, 2010, and ending on December 31, 2010’’ each 
place it appears (except in subsection (c)(2)) and in-
serting ‘‘fiscal year 2011’’; 
(2) in subsection (a) by striking ‘‘December 31, 
2010’’ and inserting ‘‘September 30, 2011’’; 
(3) in subsection (b)(2) by striking ‘‘1⁄4 of’’; 
(4) in subsection (c)— 
(A) in paragraph (2)— 
(i) by striking ‘‘1⁄4 of’’; and 
(ii) by striking ‘‘the period beginning 
on October 1, 2010, and ending on Decem-
ber 31, 2010,’’ and inserting ‘‘fiscal year 
2011’’; 
(B) in paragraph (4)— 
(i) in subparagraph (A)(ii) by striking 
‘‘, except that during such period obliga-
tions subject to such limitation shall not ex-
157 
ceed 1⁄4 of the limitation on obligations in-
cluded in an Act making appropriations for 
fiscal year 2011’’; and 
(ii) in subparagraph (B)(ii)(II) by 
striking 
‘‘$159,750,000’’ 
and 
inserting 
‘‘$639,000,000’’; and 
(C) by striking paragraph (5); 
(5) in subsection (d)— 
(A) by striking ‘‘1⁄4 of’’ each place it ap-
pears; and 
(B) in paragraph (2)(A)— 
(i) in the matter preceding clause (i) 
by striking ‘‘apportioned under sections 
104(b) and 144 of title 23, United States 
Code,’’ and inserting ‘‘specified in section 
105(a)(2) of title 23, United States Code 
(except the high priority projects pro-
gram),’’; and 
(ii) in clause (ii) by striking ‘‘appor-
tioned under such sections of such Code’’ 
and inserting ‘‘specified in such section 
105(a)(2) (except the high priority projects 
program)’’; and 
(6) in subsection (e)(1)(B) by striking ‘‘1⁄4’’.
158 
(b) ADMINISTRATIVE EXPENSES.—Section 412(a)(2) 
of the Surface Transportation Extension Act of 2010 (Pub-
lic Law 111–147; 124 Stat. 83) is amended— 
(1) by striking ‘‘$105,606,250’’ and inserting 
‘‘$422,425,000’’; and 
(2) by striking ‘‘the period beginning on October 
1, 2010, and ending on December 31, 2010’’ and in-
serting ‘‘fiscal year 2011’’. 
TITLE II—NATIONAL HIGHWAY 
TRAFFIC 
SAFETY 
ADMINIS-
TRATION, 
FEDERAL 
MOTOR 
CARRIER 
SAFETY 
ADMINIS-
TRATION, AND ADDITIONAL 
PROGRAMS 
SEC. 4201. EXTENSION OF NATIONAL HIGHWAY TRAFFIC 
SAFETY ADMINISTRATION HIGHWAY SAFETY 
PROGRAMS. 
(a) CHAPTER 4 HIGHWAY SAFETY PROGRAMS.—Sec-
tion 2001(a)(1) of SAFETEA–LU (119 Stat. 1519) is 
amended by striking ‘‘and $58,750,000 for the period begin-
ning on October 1, 2010, and ending on December 31, 
2010.’’ and inserting ‘‘and $235,000,000 for fiscal year 
2011.’’. 
(b) HIGHWAY SAFETY RESEARCH
AND DEVELOP-
MENT.—Section 2001(a)(2) of SAFETEA–LU (119 Stat.
159 
1519) is amended by striking ‘‘and $27,061,000 for the pe-
riod beginning on October 1, 2010, and ending on December 
31, 2010.’’ and inserting ‘‘and $108,244,000 for fiscal year 
2011.’’. 
(c) OCCUPANT PROTECTION INCENTIVE GRANTS.—Sec-
tion 2001(a)(3) of SAFETEA–LU (119 Stat. 1519) is 
amended by striking ‘‘and $6,250,000 for the period begin-
ning on October 1, 2010, and ending on December 31, 
2010.’’ and inserting ‘‘and $25,000,000 for fiscal year 
2011.’’. 
(d) SAFETY BELT PERFORMANCE GRANTS.—Section 
2001(a)(4) of SAFETEA–LU (119 Stat. 1519) is amended 
by striking ‘‘and $31,125,000 for the period beginning on 
October 1, 2010, and ending on December 31, 2010.’’ and 
inserting ‘‘and $124,500,000 for fiscal year 2011.’’. 
(e) STATE TRAFFIC SAFETY INFORMATION SYSTEM IM-
PROVEMENTS.—Section 2001(a)(5) of SAFETEA–LU (119 
Stat. 1519) is amended by striking ‘‘and $8,625,000 for the 
period beginning on October 1, 2010, and ending on Decem-
ber 31, 2010.’’ and inserting ‘‘and $34,500,000 for fiscal 
year 2011.’’. 
(f) ALCOHOL-IMPAIRED DRIVING COUNTERMEASURES 
INCENTIVE
GRANT
PROGRAM.—Section 2001(a)(6) of 
SAFETEA–LU (119 Stat. 1519) is amended by striking 
‘‘and $34,750,000 for the period beginning on October 1,
160 
2010, and ending on December 31, 2010.’’ and inserting 
‘‘and $139,000,000 for fiscal year 2011.’’. 
(g) 
NATIONAL
DRIVER
REGISTER.—Section 
2001(a)(7) of SAFETEA–LU (119 Stat. 1520) is amended 
by striking ‘‘and $1,029,000 for the period beginning on 
October 1, 2010, and ending on December 31, 2010.’’ and 
inserting ‘‘and $4,116,000 for fiscal year 2011.’’. 
(h) HIGH VISIBILITY ENFORCEMENT PROGRAM.—Sec-
tion 2001(a)(8) of SAFETEA–LU (119 Stat. 1520) is 
amended by striking ‘‘and $7,250,000 for the period begin-
ning on October 1, 2010, and ending on December 31, 
2010.’’ and inserting ‘‘and $29,000,000 for fiscal year 
2011.’’. 
(i) MOTORCYCLIST SAFETY.—Section 2001(a)(9) of 
SAFETEA–LU (119 Stat. 1520) is amended by striking 
‘‘and $1,750,000 for the period beginning on October 1, 
2010, and ending on December 31, 2010.’’ and inserting 
‘‘and $7,000,000 for fiscal year 2011.’’. 
(j) CHILD SAFETY AND CHILD BOOSTER SEAT SAFETY 
INCENTIVE GRANTS.—Section 2001(a)(10) of SAFETEA– 
LU (119 Stat. 1520) is amended by striking ‘‘and 
$1,750,000 for the period beginning on October 1, 2010, and 
ending on December 31, 2010.’’ and inserting ‘‘and 
$7,000,000 for fiscal year 2011.’’.
161 
(k) ADMINISTRATIVE EXPENSES.—Section 2001(a)(11) 
of SAFETEA–LU (119 Stat. 1520) is amended by striking 
‘‘and $6,332,000 for the period beginning on October 1, 
2010, and ending on December 31, 2010.’’ and inserting 
‘‘and $25,328,000 for fiscal year 2011.’’. 
SEC. 4202. EXTENSION OF FEDERAL MOTOR CARRIER SAFE-
TY ADMINISTRATION PROGRAMS. 
(a) MOTOR
CARRIER
SAFETY
GRANTS.—Section 
31104(a)(7) of title 49, United States Code, is amended by 
striking ‘‘$52,679,000 for the period beginning on October 
1, 2010, and ending on December 31, 2010.’’ and inserting 
‘‘$209,000,000 for fiscal year 2011.’’. 
(b) 
ADMINISTRATIVE
EXPENSES.—Section 
31104(i)(1)(G) of title 49, United States Code, is amended 
by striking ‘‘$61,036,000 for the period beginning on Octo-
ber 1, 2010, and ending on December 31, 2010.’’ and insert-
ing ‘‘$244,144,000 for fiscal year 2011.’’. 
(c) 
GRANT
PROGRAMS.—Section 
4101(c) 
of 
SAFETEA–LU (119 Stat. 1715) is amended— 
(1) in paragraph (1)— 
(A) by striking ‘‘and’’ after ‘‘2009,’’; and 
(B) by striking ‘‘and $6,301,000 for the pe-
riod beginning on October 1, 2010, and ending 
on December 31, 2010’’ and inserting ‘‘and 
$25,000,000 for fiscal year 2011’’;
162 
(2) 
in 
paragraph 
(2) 
by 
striking 
‘‘and 
$8,066,000 for the period beginning on October 1, 
2010, and ending on December 31, 2010’’ and insert-
ing ‘‘and $32,000,000 for fiscal year 2011’’; 
(3) 
in 
paragraph 
(3) 
by 
striking 
‘‘and 
$1,260,000 for the period beginning on October 1, 
2010, and ending on December 31, 2010’’ and insert-
ing ‘‘and $5,000,000 for fiscal year 2011’’; 
(4) 
in 
paragraph 
(4) 
by 
striking 
‘‘and 
$6,301,000 for the period beginning on October 1, 
2010, and ending on December 31, 2010’’ and insert-
ing ‘‘and $25,000,000 for fiscal year 2011’’; and 
(5) in paragraph (5) by striking ‘‘and $756,000 
for the period beginning on October 1, 2010, and end-
ing on December 31, 2010’’ and inserting ‘‘and 
$3,000,000 for fiscal year 2011’’. 
(d) HIGH-PRIORITY ACTIVITIES.—Section 31104(k)(2) 
of title 49, United States Code, is amended by striking ‘‘and 
$3,781,000 for the period beginning on October 1, 2010, and 
ending on December 31, 2010’’ and inserting ‘‘and 
$15,000,000 for fiscal year 2011’’. 
(e) NEW ENTRANT AUDITS.—Section 31144(g)(5)(B) 
of title 49, United States Code, is amended by striking 
‘‘(and up to $7,310,000 for the period beginning on October 
1, 2010, and ending on December 31, 2010)’’.
163 
(f) COMMERCIAL DRIVER’S LICENSE INFORMATION 
SYSTEM
MODERNIZATION.—Section 
4123(d)(6) 
of 
SAFETEA–LU (119 Stat. 1736) is amended by striking 
‘‘$2,016,000 for the period beginning on October 1, 2010, 
and ending on December 31, 2010.’’ and inserting 
‘‘$8,000,000 for fiscal year 2011.’’. 
(g) OUTREACH AND EDUCATION.—Section 4127(e) of 
SAFETEA–LU (119 Stat. 1741) is amended by striking 
‘‘and 2010’’ and all that follows before ‘‘to carry out’’ and 
inserting ‘‘2010, and 2011’’. 
(h) GRANT PROGRAM FOR COMMERCIAL MOTOR VEHI-
CLE OPERATORS.—Section 4134(c) of SAFETEA–LU (119 
Stat. 1744) is amended by striking ‘‘2009, 2010, and 
$252,000 for the period beginning on October 1, 2010, and 
ending on December 31, 2010,’’ and inserting ‘‘2011’’. 
(i) 
MOTOR
CARRIER
SAFETY
ADVISORY
COM-
MITTEE.—Section 4144(d) of SAFETEA–LU (119 Stat. 
1748) is amended by striking ‘‘December 31, 2010’’ and in-
serting ‘‘September 30, 2011’’. 
(j) WORKING GROUP FOR DEVELOPMENT OF PRAC-
TICES AND PROCEDURES TO ENHANCE FEDERAL-STATE 
RELATIONS.—Section 4213(d) of SAFETEA–LU (49 
U.S.C. 14710 note; 119 Stat. 1759) is amended by striking 
‘‘December 31, 2010’’ and inserting ‘‘September 30, 2011’’.
164 
SEC. 4203. ADDITIONAL PROGRAMS. 
(a) HAZARDOUS MATERIALS RESEARCH PROJECTS.— 
Section 7131(c) of SAFETEA–LU (119 Stat. 1910) is 
amended by striking ‘‘through 2010’’ and all that follows 
before ‘‘shall be available’’ and inserting ‘‘through 2011’’. 
(b) DINGELL-JOHNSON SPORT FISH RESTORATION 
ACT.—Section 4 of the Dingell-Johnson Sport Fish Restora-
tion Act (16 U.S.C. 777c) is amended— 
(1) in subsection (a) by striking ‘‘For each of fis-
cal years 2006’’ and all that follows before paragraph 
(1) and inserting the following: ‘‘For each of fiscal 
years 2006 through 2011, the balance of each annual 
appropriation made in accordance with the provi-
sions of section 3 remaining after the distributions for 
administrative expenses and other purposes under 
subsection (b) and for multistate conservation grants 
under section 14 shall be distributed as follows:’’; and 
(2) in subsection (b)(1)(A) by striking the first 
sentence and inserting the following: ‘‘From the an-
nual appropriation made in accordance with section 
3, for each of fiscal years 2006 through 2011, the Sec-
retary of the Interior may use no more than the 
amount specified in subparagraph (B) for the fiscal 
year for expenses for administration incurred in the 
implementation of this Act, in accordance with this 
section and section 9.’’.
165 
(c) SURFACE TRANSPORTATION PROJECT DELIVERY 
PILOT PROGRAM.—Section 327(i)(1) of title 23, United 
States Code, is amended by striking ‘‘6 years after’’ and 
inserting ‘‘7 years after’’. 
(d) IMPLEMENTATION OF FUTURE STRATEGIC HIGH-
WAY RESEARCH PROGRAM.—Section 510 of title 23, United 
States Code, is amended by adding at the end the following: 
‘‘(h) IMPLEMENTATION.—Notwithstanding any other 
provision of this section, the Secretary may use funds made 
available to carry out this section for implementation of 
research products related to the future strategic highway re-
search program, including development, demonstration, 
evaluation, and technology transfer activities.’’. 
TITLE III—PUBLIC 
TRANSPORTATION PROGRAMS 
SEC. 4301. ALLOCATION OF FUNDS FOR PLANNING PRO-
GRAMS. 
Section 5305(g) of title 49, United States Code, is 
amended by striking ‘‘2010, and for the period beginning 
October 1, 2010, and ending December 31, 2010,’’ and in-
serting ‘‘2011’’. 
SEC. 4302. SPECIAL RULE FOR URBANIZED AREA FORMULA 
GRANTS. 
Section 5307(b)(2) of title 49, United States Code, is 
amended—
166 
(1) in the paragraph heading by striking ‘‘2010, 
AND THE PERIOD BEGINNING OCTOBER 1, 2010, AND 
ENDING DECEMBER 31, 2010’’ and inserting ‘‘2011’’; 
(2) in subparagraph (A) by striking ‘‘2010, and 
the period beginning October 1, 2010, and ending De-
cember 31, 2010,’’ and inserting ‘‘2011,’’; and 
(3) in subparagraph (E)— 
(A) in the subparagraph heading by strik-
ing ‘‘2010 AND DURING THE PERIOD BEGINNING 
OCTOBER
1, 2010, AND
ENDING
DECEMBER
31, 
2010’’ and inserting ‘‘2011’’; and 
(B) in the matter preceding clause (i) by 
striking ‘‘In fiscal years 2008 through 2010, and 
during the period beginning October 1, 2010, 
and ending December 31, 2010,’’ and inserting 
‘‘In each of fiscal years 2008 through 2011’’. 
SEC. 4303. ALLOCATING AMOUNTS FOR CAPITAL INVEST-
MENT GRANTS. 
Section 5309(m) of title 49, United States Code, is 
amended— 
(1) in paragraph (2)— 
(A) in the paragraph heading by striking 
‘‘2010 AND OCTOBER 1, 2010, THROUGH DECEM-
BER 31, 2010’’ and inserting ‘‘2011’’;
167 
(B) in the matter preceding subparagraph 
(A) by striking ‘‘2010, and during the period be-
ginning October 1, 2010, and ending December 
31, 2010,’’ and inserting ‘‘2011’’; and 
(C) in subparagraph (A)(i) by striking 
‘‘2010, and $50,000,000 for the period beginning 
October 1, 2010, and ending December 31, 
2010,’’ and inserting ‘‘2011’’; 
(2) in paragraph (6)— 
(A) in subparagraph (B) by striking ‘‘2010, 
and $3,750,000 shall be available for the period 
beginning October 1, 2010, and ending December 
31, 2010,’’ and inserting ‘‘2011’’; and 
(B) in subparagraph (C) by striking ‘‘2010, 
and $1,250,000 shall be available for the period 
beginning October 1, 2010 and ending December 
31, 2010,’’ and inserting ‘‘2011’’; and 
(3) in paragraph (7)— 
(A) in subparagraph (A)— 
(i) by striking ‘‘(A) FERRY BOAT SYS-
TEMS.—’’ and all that follows through ‘‘(i) 
FISCAL
YEAR
2006
THROUGH
2010.— 
$10,000,000 shall be available in each of fis-
cal years 2006 through 2010’’ and inserting 
the following:
168 
‘‘(A) FERRY BOAT SYSTEMS.—$10,000,000 
shall be available in each of fiscal years 2006 
through 2011’’; 
(ii) by striking clause (ii); 
(iii) by redesignating subclauses (I) 
through (VIII) as clauses (i) through (viii), 
respectively, and moving the text of such 
clauses 2 ems to the left; and 
(iv) by inserting a period at the end of 
clause (iv) (as so redesignated); 
(B) by striking subparagraph (B)(vi) and 
inserting the following: 
‘‘(vi) 
$13,500,000 
for 
fiscal 
year 
2011.’’; 
(C) in subparagraph (C) by striking ‘‘, and 
during the period beginning October 1, 2010, 
and ending December 31, 2010,’’; 
(D) in subparagraph (D) by striking ‘‘, and 
not less than $8,750,000 shall be available for the 
period beginning October 1, 2010, and ending 
December 31, 2010,’’; and 
(E) in subparagraph (E) by striking ‘‘, and 
$750,000 shall be available for the period begin-
ning October 1, 2010, and ending December 31, 
2010,’’.
169 
SEC. 4304. APPORTIONMENT OF FORMULA GRANTS FOR 
OTHER THAN URBANIZED AREAS. 
Section 5311(c)(1)(F) of title 49, United States Code, 
is amended to read as follows: 
‘‘(F) $15,000,000 for fiscal year 2011.’’. 
SEC. 4305. APPORTIONMENT BASED ON FIXED GUIDEWAY 
FACTORS. 
Section 5337 of title 49, United States Code, is amend-
ed— 
(1) in subsection (a), in the matter preceding 
paragraph (1), by striking ‘‘2010’’ and inserting 
‘‘2011’’; and 
(2) by striking subsection (g). 
SEC. 4306. AUTHORIZATIONS FOR PUBLIC TRANSPOR-
TATION. 
(a) FORMULA AND BUS GRANTS.—Section 5338(b) of 
title 49, United States Code, is amended— 
(1) by striking paragraph (1)(F) and inserting 
the following: 
‘‘(F) $8,360,565,000 for fiscal year 2011.’’; 
and 
(2) in paragraph (2)— 
(A) in subparagraph (A) by striking 
‘‘$28,375,000 for the period beginning October 1, 
2010, and ending December 31, 2010,’’ and in-
serting ‘‘$113,500,000 for fiscal year 2011’’;
170 
(B) in subparagraph (B) by striking 
‘‘$1,040,091,250 for the period beginning October 
1, 2010, and ending December 31, 2010,’’ and 
inserting ‘‘$4,160,365,000 for fiscal year 2011’’; 
(C) in subparagraph (C) by striking 
‘‘$12,875,000 for the period beginning October 1, 
2010, and ending December 31, 2010,’’ and in-
serting ‘‘$51,500,000 for fiscal year 2011’’; 
(D) in subparagraph (D) by striking 
‘‘$416,625,000 for the period beginning October 
1, 2010 and ending December 31, 2010,’’ and in-
serting ‘‘$1,666,500,000 for fiscal year 2011’’; 
(E) in subparagraph (E) by striking 
‘‘$246,000,000 for the period beginning October 
1, 2010 and ending December 31, 2010,’’ and in-
serting ‘‘$984,000,000 for fiscal year 2011’’; 
(F) in subparagraph (F) by striking 
‘‘$33,375,000 for the period beginning October 1, 
2010 and ending December 31, 2010,’’ and in-
serting ‘‘$133,500,000 for fiscal year 2011’’; 
(G) in subparagraph (G) by striking 
‘‘$116,250,000 for the period beginning October 
1, 2010 and ending December 31, 2010,’’ and in-
serting ‘‘$465,000,000 for fiscal year 2011’’;
171 
(H) in subparagraph (H) by striking 
‘‘$41,125,000 for the period beginning October 1, 
2010 and ending December 31, 2010,’’ and in-
serting ‘‘$164,500,000 for fiscal year 2011’’; 
(I) 
in 
subparagraph 
(I) 
by 
striking 
‘‘$23,125,000 for the period beginning October 1, 
2010 and ending December 31, 2010,’’ and in-
serting ‘‘$92,500,000 for fiscal year 2011’’; 
(J) in subparagraph (J) by striking 
‘‘$6,725,000 for the period beginning October 1, 
2010 and ending December 31, 2010,’’ and in-
serting ‘‘$26,900,000 for fiscal year 2011’’; 
(K) in subparagraph (K) by striking 
‘‘$875,000 for the period beginning October 1, 
2010 and ending December 31, 2010,’’ and in-
serting ‘‘$3,500,000 for fiscal year 2011’’; 
(L) in subparagraph (L) by striking 
‘‘$6,250,000 for the period beginning October 1, 
2010 and ending December 31, 2010,’’ and in-
serting ‘‘$25,000,000 for fiscal year 2011’’; 
(M) in subparagraph (M) by striking 
‘‘$116,250,000 for the period beginning October 
1, 2010 and ending December 31, 2010,’’ and in-
serting ‘‘$465,000,000 for fiscal year 2011’’; and
172 
(N) in subparagraph (N) by striking 
‘‘$2,200,000 for the period beginning October 1, 
2010 and ending December 31, 2010,’’ and in-
serting ‘‘$8,800,000 for fiscal year 2011’’. 
(b) 
CAPITAL
INVESTMENT
GRANTS.—Section 
5338(c)(6) of title 49, United States Code, is amended to 
read as follows: 
‘‘(6) $2,000,000,000 for fiscal year 2011.’’. 
(c) RESEARCH
AND UNIVERSITY RESEARCH CEN-
TERS.—Section 5338(d) of title 49, United States Code, is 
amended— 
(1) in paragraph (1)— 
(A) in the matter preceding subparagraph 
(A) by striking ‘‘$17,437,500 for the period be-
ginning October 1, 2010, and ending December 
31, 2010’’ and inserting ‘‘$69,750,000 for fiscal 
year 2011’’; and 
(B) in subparagraph (A) by striking ‘‘fiscal 
year 2009’’ and inserting ‘‘each of fiscal years 
2009, 2010, and 2011’’; 
(2) in paragraph (2)(A)— 
(A) in clauses (i), (ii), and (iii) by striking 
‘‘2009’’ and inserting ‘‘2011’’; and
173 
(B) in clauses (v), (vi), (vii), and (viii) by 
striking ‘‘and 2009’’ and inserting ‘‘through 
2011’’; and 
(3) by striking paragraph (3) and inserting the 
following: 
‘‘(3) FUNDING.—If the Secretary determines that 
a project or activity described in paragraph (2) re-
ceived sufficient funds in fiscal year 2010, or a pre-
vious fiscal year, to carry out the purpose for which 
the project or activity was authorized, the Secretary 
may not allocate any amounts under paragraph (2) 
for the project or activity for fiscal year 2011, or any 
subsequent fiscal year.’’. 
(d) ADMINISTRATION.—Section 5338(e)(6) of title 49, 
United States Code, is amended to read as follows: 
‘‘(6) $98,911,000 for fiscal year 2011.’’. 
SEC. 4307. AMENDMENTS TO SAFETEA–LU. 
(a) 
CONTRACTED
PARATRANSIT
PILOT.—Section 
3009(i)(1) of SAFETEA–LU (119 Stat. 1572) is amended 
by striking ‘‘2010, and for the period beginning October 1, 
2010, and ending December 31, 2010’’ and inserting 
‘‘2011’’. 
(b) PUBLIC-PRIVATE
PARTNERSHIP
PILOT
PRO-
GRAM.—Section 3011 of SAFETEA–LU (49 U.S.C. 5309 
note; 119 Stat. 1588) is amended—
174 
(1) in subsection (c)(5) by striking ‘‘2010 and 
the period beginning October 1, 2010, and ending De-
cember 31, 2010’’ and inserting ‘‘2011’’; and 
(2) in subsection (d) by striking ‘‘2010, and for 
the period beginning October 1, 2010, and ending De-
cember 31, 2010’’ and inserting ‘‘2011’’. 
(c) ELDERLY INDIVIDUALS AND INDIVIDUALS WITH 
DISABILITIES PILOT PROGRAM.—Section 3012(b)(8) of 
SAFETEA–LU (49 U.S.C. 5310 note; 119 Stat. 1593) is 
amended by striking ‘‘December 31, 2010’’ and inserting 
‘‘September 30, 2011’’. 
(d) 
OBLIGATION
CEILING.—Section 
3040(7) 
of 
SAFETEA–LU (119 Stat. 1639) is amended to read as fol-
lows: 
‘‘(7) $10,507,752,000 for fiscal year 2011, of 
which not more than $8,360,565,000 shall be from the 
Mass Transit Account.’’. 
(e) PROJECT
AUTHORIZATIONS
FOR
NEW
FIXED 
GUIDEWAY
CAPITAL
PROJECTS.—Section 
3043 
of 
SAFETEA–LU (119 Stat. 1640) is amended— 
(1) in subsection (b), in the matter preceding 
paragraph (1), by striking ‘‘2010, and for the period 
beginning October 1, 2010, and ending December 31, 
2010,’’ and inserting ‘‘2011’’; and
175 
(2) in subsection (c), in the matter preceding 
paragraph (1), by striking ‘‘2010, and for the period 
beginning October 1, 2010, and ending December 31, 
2010,’’ and inserting ‘‘2011’’. 
(f) ALLOCATIONS
FOR NATIONAL RESEARCH
AND 
TECHNOLOGY PROGRAMS.—Section 3046 of SAFETEA–LU 
(49 U.S.C. 5338 note; 119 Stat. 1706) is amended— 
(1) in subsection (b) by striking ‘‘or period’’; 
(2) by striking subsection (c) and inserting the 
following: 
‘‘(c) ADDITIONAL APPROPRIATIONS.—The Secretary 
shall allocate amounts appropriated pursuant to section 
5338(d) of title 49, United States Code, for national re-
search and technology programs under sections 5312, 5314, 
and 5322 of such title for fiscal years 2010 and 2011, in 
amounts equal to the amounts allocated for fiscal year 2009 
under each of paragraphs (2), (3), (5), (6), and (8) through 
(25) of subsection (a).’’; and 
(3) in subsection (d)— 
(A) by striking ‘‘2009’’ and inserting 
‘‘2010’’; and 
(B) by striking ‘‘2010’’ and inserting 
‘‘2011’’.
176 
SEC. 4308. LEVEL OF OBLIGATION LIMITATIONS. 
(a) 
HIGHWAY
CATEGORY.—Section 
8003(a) 
of 
SAFETEA–LU (2 U.S.C. 901 note; 119 Stat. 1917) is 
amended— 
(1) in paragraph (6) by striking ‘‘for the period 
beginning on October 1, 2009, and ending on Sep-
tember 30, 2010,’’ and inserting ‘‘for fiscal year 
2010,’’; and 
(2) by striking paragraph (7) and inserting the 
following: 
‘‘(7) for fiscal year 2011, $42,469,970,178.’’. 
(b) MASS TRANSIT CATEGORY.—Section 8003(b) of 
SAFETEA–LU (2 U.S.C. 901 note; 119 Stat. 1917) is 
amended— 
(1) in paragraph (6) by striking ‘‘for the period 
beginning on October 1, 2009, and ending on Decem-
ber 31, 2010,’’ and inserting ‘‘for fiscal year 2010,’’; 
and 
(2) by striking paragraph (7) and inserting the 
following: 
‘‘(7) for fiscal year 2011, $10,338,065,000.’’. 
TITLE IV—EXTENSION OF 
EXPENDITURE AUTHORITY 
SEC. 4401. EXTENSION OF EXPENDITURE AUTHORITY. 
(a) HIGHWAY TRUST FUND.—Section 9503 of the In-
ternal Revenue Code of 1986 is amended—
177 
(1) by striking ‘‘December 31, 2010 (January 1, 
2011, in the case of expenditures for administrative 
expenses)’’ in subsections (b)(6)(B) and (c)(1) and in-
serting ‘‘October 1, 2011’’; 
(2) by striking ‘‘the Surface Transportation Ex-
tension Act of 2010’’ in subsections (c)(1) and (e)(3) 
and inserting ‘‘the Surface Transportation Extension 
Act of 2010, Part II’’; and 
(3) by striking ‘‘January 1, 2011’’ in subsection 
(e)(3) and inserting ‘‘October 1, 2011’’. 
(b) SPORT FISH RESTORATION AND BOATING TRUST 
FUND.—Section 9504 of the Internal Revenue Code of 1986 
is amended— 
(1) by striking ‘‘Surface Transportation Exten-
sion Act of 2010’’ each place it appears in subsection 
(b)(2) and inserting ‘‘Surface Transportation Exten-
sion Act of 2010, Part II’’; and 
(2) by striking ‘‘January 1, 2011’’ in subsection 
(d)(2) and inserting ‘‘October 1, 2011’’. 
(c) EFFECTIVE DATE.—The amendments made by this 
section shall take effect on December 31, 2010.
178 
DIVISION C—AIRPORT AND 
AIRWAY EXTENSION 
SEC. 5001. SHORT TITLE. 
This division may be cited as the ‘‘Airport and Airway 
Extension Act of 2010, Part IV’’. 
SEC. 5002. EXTENSION OF TAXES FUNDING AIRPORT AND 
AIRWAY TRUST FUND. 
(a) FUEL
TAXES.—Subparagraph (B) of section 
4081(d)(2) of the Internal Revenue Code of 1986 is amended 
by striking ‘‘December 31, 2010’’ and inserting ‘‘September 
30, 2011’’. 
(b) TICKET TAXES.— 
(1) 
PERSONS.—Clause 
(ii) 
of 
section 
4261(j)(1)(A) of the Internal Revenue Code of 1986 is 
amended by striking ‘‘December 31, 2010’’ and insert-
ing ‘‘September 30, 2011’’. 
(2) 
PROPERTY.—Clause 
(ii) 
of 
section 
4271(d)(1)(A) of such Code is amended by striking 
‘‘December 31, 2010’’ and inserting ‘‘September 30, 
2011’’. 
(c) EFFECTIVE DATE.—The amendments made by this 
section shall take effect on January 1, 2011.
179 
SEC. 5003. EXTENSION OF AIRPORT AND AIRWAY TRUST 
FUND EXPENDITURE AUTHORITY. 
(a) IN GENERAL.—Paragraph (1) of section 9502(d) 
of the Internal Revenue Code of 1986 is amended— 
(1) by striking ‘‘January 1, 2011’’ and inserting 
‘‘October 1, 2011’’; and 
(2) by inserting ‘‘or the Airport and Airway Ex-
tension Act of 2010, Part IV’’ before the semicolon at 
the end of subparagraph (A). 
(b) CONFORMING AMENDMENT.—Paragraph (2) of sec-
tion 9502(e) of such Code is amended by striking ‘‘January 
1, 2011’’ and inserting ‘‘October 1, 2011’’. 
(c) EFFECTIVE DATE.—The amendments made by this 
section shall take effect on January 1, 2011. 
SEC. 5004. EXTENSION OF AIRPORT IMPROVEMENT PRO-
GRAM. 
(a) AUTHORIZATION
OF APPROPRIATIONS.—Section 
48103(8) of title 49, United States Code, is amended to read 
as follows: 
‘‘(8) $3,700,000,000 for fiscal year 2011.’’. 
(b) PROJECT GRANT AUTHORITY.—Section 47104(c) of 
such title is amended by striking ‘‘December 31, 2010,’’ and 
inserting ‘‘September 30, 2011,’’.
180 
SEC. 5005. EXTENSION OF EXPIRING AUTHORITIES. 
(a) Section 40117(l)(7) of title 49, United States Code, 
is amended by striking ‘‘January 1, 2011.’’ and inserting 
‘‘October 1, 2011.’’. 
(b) Section 44302(f)(1) of such title is amended— 
(1) by striking ‘‘December 31, 2010,’’ and insert-
ing ‘‘September 30, 2011,’’; and 
(2) by striking ‘‘March 31, 2011,’’ and inserting 
‘‘December 31, 2011,’’. 
(c) Section 44303(b) of such title is amended by strik-
ing ‘‘March 31, 2011,’’ and inserting ‘‘December 31, 2011,’’. 
(d) Section 47107(s)(3) of such title is amended by 
striking ‘‘January 1, 2011.’’ and inserting ‘‘October 1, 
2011.’’. 
(e) Section 47115(j) of such title is amended by strik-
ing ‘‘fiscal years 2004 through 2010, and for the portion 
of fiscal year 2011 ending before January 1, 2011,’’ and 
inserting ‘‘fiscal years 2004 through 2011,’’. 
(f) Section 47141(f) of such title is amended by strik-
ing ‘‘December 31, 2010.’’ and inserting ‘‘September 30, 
2011.’’. 
(g) Section 49108 of such title is amended by striking 
‘‘December 31, 2010,’’ and inserting ‘‘September 30, 2011,’’. 
(h) Section 161 of the Vision 100—Century of Avia-
tion Reauthorization Act (49 U.S.C. 47109 note) is amend-
ed by striking ‘‘fiscal year 2009 or 2010, or in the portion
181 
of fiscal year 2011 ending before January 1, 2011,’’ and 
inserting ‘‘fiscal year 2009, 2010, or 2011’’. 
(i) Section 186(d) of such Act (117 Stat. 2518) is 
amended by striking ‘‘for fiscal years ending before October 
1, 2010, and for the portion of fiscal year 2011 ending be-
fore January 1, 2011,’’ and inserting ‘‘for fiscal years end-
ing before October 1, 2011,’’. 
(j) The amendments made by this section shall take 
effect on January 1, 2011. 
DIVISION D—FOOD SAFETY 
SEC. 6001. SHORT TITLE; REFERENCES; TABLE OF CON-
TENTS. 
(a) SHORT TITLE.—This division may be cited as the 
‘‘FDA Food Safety Modernization Act’’. 
(b) REFERENCES.—Except as otherwise specified, 
whenever in this division an amendment is expressed in 
terms of an amendment to a section or other provision, the 
reference shall be considered to be made to a section or other 
provision of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.). 
(c) TABLE OF CONTENTS.—The table of contents for 
this division is as follows: 
DIVISION D—FOOD SAFETY 
Sec. 6001. Short title; references; table of contents. 
TITLE I—IMPROVING CAPACITY TO PREVENT FOOD SAFETY 
PROBLEMS 
Sec. 6101. Inspections of records.
182 
Sec. 6102. Registration of food facilities. 
Sec. 6103. Hazard analysis and risk-based preventive controls. 
Sec. 6104. Performance standards. 
Sec. 6105. Standards for produce safety. 
Sec. 6106. Protection against intentional adulteration. 
Sec. 6107. Authority to collect fees. 
Sec. 6108. National agriculture and food defense strategy. 
Sec. 6109. Food and Agriculture Coordinating Councils. 
Sec. 6110. Building domestic capacity. 
Sec. 6111. Sanitary transportation of food. 
Sec. 6112. Food allergy and anaphylaxis management. 
Sec. 6113. New dietary ingredients. 
Sec. 6114. Requirement for guidance relating to post-harvest processing of raw 
oysters. 
Sec. 6115. Port shopping. 
Sec. 6116. Alcohol-related facilities. 
TITLE II—IMPROVING CAPACITY TO DETECT AND RESPOND TO 
FOOD SAFETY PROBLEMS 
Sec. 6201. Targeting of inspection resources for domestic facilities, foreign facili-
ties, and ports of entry; annual report. 
Sec. 6202. Laboratory accreditation for analyses of foods. 
Sec. 6203. Integrated consortium of laboratory networks. 
Sec. 6204. Enhancing tracking and tracing of food and recordkeeping. 
Sec. 6205. Surveillance. 
Sec. 6206. Mandatory recall authority. 
Sec. 6207. Administrative detention of food. 
Sec. 6208. Decontamination and disposal standards and plans. 
Sec. 6209. Improving the training of State, local, territorial, and tribal food safe-
ty officials. 
Sec. 6210. Enhancing food safety. 
Sec. 6211. Improving the reportable food registry. 
TITLE III—IMPROVING THE SAFETY OF IMPORTED FOOD 
Sec. 6301. Foreign supplier verification program. 
Sec. 6302. Voluntary qualified importer program. 
Sec. 6303. Authority to require import certifications for food. 
Sec. 6304. Prior notice of imported food shipments. 
Sec. 6305. Building capacity of foreign governments with respect to food safety. 
Sec. 6306. Inspection of foreign food facilities. 
Sec. 6307. Accreditation of third-party auditors. 
Sec. 6308. Foreign offices of the Food and Drug Administration. 
Sec. 6309. Smuggled food. 
TITLE IV—MISCELLANEOUS PROVISIONS 
Sec. 6401. Funding for food safety. 
Sec. 6402. Employee protections. 
Sec. 6403. Jurisdiction; authorities. 
Sec. 6404. Compliance with international agreements. 
Sec. 6405. Determination of budgetary effects.
183 
TITLE I—IMPROVING CAPACITY 
TO PREVENT FOOD SAFETY 
PROBLEMS 
SEC. 6101. INSPECTIONS OF RECORDS. 
(a) IN GENERAL.—Section 414(a) (21 U.S.C. 350c(a)) 
is amended— 
(1) by striking the subsection heading and all 
that follows through ‘‘of food is’’ and inserting the fol-
lowing: ‘‘RECORDS INSPECTION.— 
‘‘(1) ADULTERATED FOOD.—If the Secretary has 
a reasonable belief that an article of food, and any 
other article of food that the Secretary reasonably be-
lieves is likely to be affected in a similar manner, is’’; 
(2) by inserting ‘‘, and to any other article of 
food that the Secretary reasonably believes is likely to 
be affected in a similar manner,’’ after ‘‘relating to 
such article’’; 
(3) by striking the last sentence; and 
(4) by inserting at the end the following: 
‘‘(2) USE OF OR EXPOSURE TO FOOD OF CON-
CERN.—If the Secretary believes that there is a rea-
sonable probability that the use of or exposure to an 
article of food, and any other article of food that the 
Secretary reasonably believes is likely to be affected in 
a similar manner, will cause serious adverse health
184 
consequences or death to humans or animals, each 
person (excluding farms and restaurants) who manu-
factures, processes, packs, distributes, receives, holds, 
or imports such article shall, at the request of an offi-
cer or employee duly designated by the Secretary, per-
mit such officer or employee, upon presentation of ap-
propriate credentials and a written notice to such 
person, at reasonable times and within reasonable 
limits and in a reasonable manner, to have access to 
and copy all records relating to such article and to 
any other article of food that the Secretary reasonably 
believes is likely to be affected in a similar manner, 
that are needed to assist the Secretary in determining 
whether there is a reasonable probability that the use 
of or exposure to the food will cause serious adverse 
health consequences or death to humans or animals. 
‘‘(3) 
APPLICATION.—The 
requirement 
under 
paragraphs (1) and (2) applies to all records relating 
to the manufacture, processing, packing, distribution, 
receipt, holding, or importation of such article main-
tained by or on behalf of such person in any format 
(including paper and electronic formats) and at any 
location.’’. 
(b) CONFORMING AMENDMENT.—Section 704(a)(1)(B) 
(21 U.S.C. 374(a)(1)(B)) is amended by striking ‘‘section
185 
414 when’’ and all that follows through ‘‘subject to’’ and 
inserting ‘‘section 414, when the standard for records in-
spection under paragraph (1) or (2) of section 414(a) ap-
plies, subject to’’. 
SEC. 6102. REGISTRATION OF FOOD FACILITIES. 
(a) UPDATING OF FOOD CATEGORY REGULATIONS; BI-
ENNIAL REGISTRATION RENEWAL.—Section 415(a) (21 
U.S.C. 350d(a)) is amended— 
(1) in paragraph (2), by— 
(A) striking ‘‘conducts business and’’ and 
inserting ‘‘conducts business, the e-mail address 
for the contact person of the facility or, in the 
case of a foreign facility, the United States agent 
for the facility, and’’; and 
(B) inserting ‘‘, or any other food categories 
as determined appropriate by the Secretary, in-
cluding by guidance’’ after ‘‘Code of Federal 
Regulations’’; 
(2) by redesignating paragraphs (3) and (4) as 
paragraphs (4) and (5), respectively; and 
(3) by inserting after paragraph (2) the fol-
lowing: 
‘‘(3) BIENNIAL REGISTRATION RENEWAL.—Dur-
ing the period beginning on October 1 and ending on 
December 31 of each even-numbered year, a registrant
187 
a reasonable probability of causing serious adverse 
health consequences or death to humans or animals, 
the Secretary may by order suspend the registration 
of a facility— 
‘‘(A) that created, caused, or was otherwise 
responsible for such reasonable probability; or 
‘‘(B)(i) that knew of, or had reason to know 
of, such reasonable probability; and 
‘‘(ii) packed, received, or held such food. 
‘‘(2) HEARING ON SUSPENSION.—The Secretary 
shall provide the registrant subject to an order under 
paragraph (1) with an opportunity for an informal 
hearing, to be held as soon as possible but not later 
than 2 business days after the issuance of the order 
or such other time period, as agreed upon by the Sec-
retary and the registrant, on the actions required for 
reinstatement of registration and why the registration 
that is subject to suspension should be reinstated. The 
Secretary shall reinstate a registration if the Sec-
retary determines, based on evidence presented, that 
adequate grounds do not exist to continue the suspen-
sion of the registration. 
‘‘(3) POST-HEARING CORRECTIVE ACTION PLAN; 
VACATING OF ORDER.—
188 
‘‘(A) CORRECTIVE ACTION PLAN.—If, after 
providing opportunity for an informal hearing 
under paragraph (2), the Secretary determines 
that the suspension of registration remains nec-
essary, the Secretary shall require the registrant 
to submit a corrective action plan to demonstrate 
how the registrant plans to correct the conditions 
found by the Secretary. The Secretary shall re-
view such plan not later than 14 days after the 
submission of the corrective action plan or such 
other time period as determined by the Sec-
retary. 
‘‘(B) VACATING OF ORDER.—Upon a deter-
mination by the Secretary that adequate grounds 
do not exist to continue the suspension actions 
required by the order, or that such actions should 
be modified, the Secretary shall promptly vacate 
the order and reinstate the registration of the fa-
cility subject to the order or modify the order, as 
appropriate. 
‘‘(4) EFFECT OF SUSPENSION.—If the registra-
tion of a facility is suspended under this subsection, 
no person shall import or export food into the United 
States from such facility, offer to import or export 
food into the United States from such facility, or oth-
189 
erwise introduce food from such facility into inter-
state or intrastate commerce in the United States. 
‘‘(5) REGULATIONS.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
promulgate regulations to implement this sub-
section. The Secretary may promulgate such reg-
ulations on an interim final basis. 
‘‘(B) REGISTRATION
REQUIREMENT.—The 
Secretary may require that registration under 
this section be submitted in an electronic format. 
Such requirement may not take effect before the 
date that is 5 years after the date of enactment 
of the FDA Food Safety Modernization Act. 
‘‘(6) APPLICATION
DATE.—Facilities shall be 
subject to the requirements of this subsection begin-
ning on the earlier of— 
‘‘(A) the date on which the Secretary issues 
regulations under paragraph (5); or 
‘‘(B) 180 days after the date of enactment 
of the FDA Food Safety Modernization Act. 
‘‘(7) NO DELEGATION.—The authority conferred 
by this subsection to issue an order to suspend a reg-
istration or vacate an order of suspension shall not 
be delegated to any officer or employee other than the 
Commissioner.’’.
190 
(2) 
SMALL
ENTITY
COMPLIANCE
POLICY 
GUIDE.—Not later than 180 days after the issuance of 
the regulations promulgated under section 415(b)(5) 
of the Federal Food, Drug, and Cosmetic Act (as 
added by this section), the Secretary shall issue a 
small entity compliance policy guide setting forth in 
plain language the requirements of such regulations to 
assist small entities in complying with registration 
requirements and other activities required under such 
section. 
(3) IMPORTED FOOD.—Section 801(l) (21 U.S.C. 
381(l)) is amended by inserting ‘‘(or for which a reg-
istration has been suspended under such section)’’ 
after ‘‘section 415’’. 
(c) CLARIFICATION OF INTENT.— 
(1) RETAIL
FOOD
ESTABLISHMENT.—The Sec-
retary shall amend the definition of the term ‘‘retail 
food establishment’’ in section 1.227(b)(11) of title 21, 
Code of Federal Regulations to clarify that, in deter-
mining the primary function of an establishment or 
a retail food establishment under such section, the sale 
of food products directly to consumers by such estab-
lishment and the sale of food directly to consumers by 
such retail food establishment include—
191 
(A) the sale of such food products or food di-
rectly to consumers by such establishment at a 
roadside stand or farmers’ market where such 
stand or market is located other than where the 
food was manufactured or processed; 
(B) the sale and distribution of such food 
through a community supported agriculture pro-
gram; and 
(C) the sale and distribution of such food at 
any other such direct sales platform as deter-
mined by the Secretary. 
(2) DEFINITIONS.—For purposes of paragraph 
(1)— 
(A) the term ‘‘community supported agri-
culture program’’ has the same meaning given 
the term ‘‘community supported agriculture 
(CSA) program’’ in section 249.2 of title 7, Code 
of Federal Regulations (or any successor regula-
tion); and 
(B) the term ‘‘consumer’’ does not include a 
business. 
(d) CONFORMING AMENDMENTS.— 
(1) Section 301(d) (21 U.S.C. 331(d)) is amend-
ed by inserting ‘‘415,’’ after ‘‘404,’’.
192 
(2) Section 415(d), as redesignated by subsection 
(b), is amended by adding at the end before the period 
‘‘for a facility to be registered, except with respect to 
the reinstatement of a registration that is suspended 
under subsection (b)’’. 
SEC. 6103. HAZARD ANALYSIS AND RISK-BASED PREVEN-
TIVE CONTROLS. 
(a) IN GENERAL.—Chapter IV (21 U.S.C. 341 et seq.) 
is amended by adding at the end the following: 
‘‘SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVEN-
TIVE CONTROLS. 
‘‘(a) IN GENERAL.—The owner, operator, or agent in 
charge of a facility shall, in accordance with this section, 
evaluate the hazards that could affect food manufactured, 
processed, packed, or held by such facility, identify and im-
plement preventive controls to significantly minimize or 
prevent the occurrence of such hazards and provide assur-
ances that such food is not adulterated under section 402 
or misbranded under section 403(w), monitor the perform-
ance of those controls, and maintain records of this moni-
toring as a matter of routine practice. 
‘‘(b) HAZARD ANALYSIS.—The owner, operator, or 
agent in charge of a facility shall—
193 
‘‘(1) identify and evaluate known or reasonably 
foreseeable hazards that may be associated with the 
facility, including— 
‘‘(A) biological, chemical, physical, and ra-
diological hazards, natural toxins, pesticides, 
drug residues, decomposition, parasites, aller-
gens, and unapproved food and color additives; 
and 
‘‘(B) hazards that occur naturally, or may 
be unintentionally introduced; and 
‘‘(2) identify and evaluate hazards that may be 
intentionally introduced, including by acts of ter-
rorism; and 
‘‘(3) develop a written analysis of the hazards. 
‘‘(c) PREVENTIVE CONTROLS.—The owner, operator, or 
agent in charge of a facility shall identify and implement 
preventive controls, including at critical control points, if 
any, to provide assurances that— 
‘‘(1) hazards identified in the hazard analysis 
conducted under subsection (b)(1) will be significantly 
minimized or prevented; 
‘‘(2) any hazards identified in the hazard anal-
ysis conducted under subsection (b)(2) will be signifi-
cantly minimized or prevented and addressed, con-
sistent with section 420, as applicable; and
196 
section (f)(4), instances when corrective actions were imple-
mented, and the efficacy of preventive controls and correc-
tive actions. 
‘‘(h) WRITTEN
PLAN
AND
DOCUMENTATION.—The 
owner, operator, or agent in charge of a facility shall pre-
pare a written plan that documents and describes the proce-
dures used by the facility to comply with the requirements 
of this section, including analyzing the hazards under sub-
section (b) and identifying the preventive controls adopted 
under subsection (c) to address those hazards. Such written 
plan, together with the documentation described in sub-
section (g), shall be made promptly available to a duly au-
thorized representative of the Secretary upon oral or written 
request. 
‘‘(i) REQUIREMENT TO REANALYZE.—The owner, op-
erator, or agent in charge of a facility shall conduct a rea-
nalysis under subsection (b) whenever a significant change 
is made in the activities conducted at a facility operated 
by such owner, operator, or agent if the change creates a 
reasonable potential for a new hazard or a significant in-
crease in a previously identified hazard or not less fre-
quently than once every 3 years, whichever is earlier. Such 
reanalysis shall be completed and additional preventive 
controls needed to address the hazard identified, if any, 
shall be implemented before the change in activities at the
197 
facility is operative. Such owner, operator, or agent shall 
revise the written plan required under subsection (h) if such 
a significant change is made or document the basis for the 
conclusion that no additional or revised preventive controls 
are needed. The Secretary may require a reanalysis under 
this section to respond to new hazards and developments 
in scientific understanding, including, as appropriate, re-
sults from the Department of Homeland Security biological, 
chemical, radiological, or other terrorism risk assessment. 
‘‘(j) EXEMPTION FOR SEAFOOD, JUICE, AND LOW-ACID 
CANNED FOOD FACILITIES SUBJECT TO HACCP.— 
‘‘(1) IN GENERAL.—This section shall not apply 
to a facility if the owner, operator, or agent in charge 
of such facility is required to comply with, and is in 
compliance with, 1 of the following standards and 
regulations with respect to such facility: 
‘‘(A) The Seafood Hazard Analysis Critical 
Control Points Program of the Food and Drug 
Administration. 
‘‘(B) The Juice Hazard Analysis Critical 
Control Points Program of the Food and Drug 
Administration. 
‘‘(C) The Thermally Processed Low-Acid 
Foods Packaged in Hermetically Sealed Con-
198 
tainers standards of the Food and Drug Admin-
istration (or any successor standards). 
‘‘(2) 
APPLICABILITY.—The 
exemption 
under 
paragraph (1)(C) shall apply only with respect to 
microbiological hazards that are regulated under the 
standards for Thermally Processed Low-Acid Foods 
Packaged in Hermetically Sealed Containers under 
part 113 of chapter 21, Code of Federal Regulations 
(or any successor regulations). 
‘‘(k) EXCEPTION FOR ACTIVITIES OF FACILITIES SUB-
JECT TO SECTION 419.—This section shall not apply to ac-
tivities of a facility that are subject to section 419. 
‘‘(l) MODIFIED REQUIREMENTS FOR QUALIFIED FA-
CILITIES.— 
‘‘(1) QUALIFIED FACILITIES.— 
‘‘(A) IN GENERAL.—A facility is a qualified 
facility for purposes of this subsection if the fa-
cility meets the conditions under subparagraph 
(B) or (C). 
‘‘(B) VERY SMALL BUSINESS.—A facility is 
a qualified facility under this subparagraph— 
‘‘(i) if the facility, including any sub-
sidiary or affiliate of the facility, is, collec-
tively, a very small business (as defined in
199 
the regulations promulgated under sub-
section (n)); and 
‘‘(ii) in the case where the facility is a 
subsidiary or affiliate of an entity, if such 
subsidiaries or affiliates, are, collectively, a 
very small business (as so defined). 
‘‘(C) LIMITED ANNUAL MONETARY VALUE OF 
SALES.— 
‘‘(i) IN
GENERAL.—A facility is a 
qualified facility under this subparagraph 
if clause (ii) applies— 
‘‘(I) to the facility, including any 
subsidiary or affiliate of the facility, 
collectively; and 
‘‘(II) to the subsidiaries or affili-
ates, collectively, of any entity of which 
the facility is a subsidiary or affiliate. 
‘‘(ii) AVERAGE
ANNUAL
MONETARY 
VALUE.—This clause applies if— 
‘‘(I) during the 3-year period pre-
ceding the applicable calendar year, 
the average annual monetary value of 
the 
food 
manufactured, 
processed, 
packed, or held at such facility (or the 
collective average annual monetary
200 
value of such food at any subsidiary or 
affiliate, as described in clause (i)) 
that is sold directly to qualified end- 
users during such period exceeded the 
average annual monetary value of the 
food manufactured, processed, packed, 
or held at such facility (or the collec-
tive average annual monetary value of 
such food at any subsidiary or affil-
iate, as so described) sold by such facil-
ity (or collectively by any such sub-
sidiary or affiliate) to all other pur-
chasers during such period; and 
‘‘(II) the average annual mone-
tary value of all food sold by such fa-
cility (or the collective average annual 
monetary value of such food sold by 
any subsidiary or affiliate, as de-
scribed in clause (i)) during such pe-
riod was less than $500,000, adjusted 
for inflation. 
‘‘(2) EXEMPTION.—A qualified facility— 
‘‘(A) shall not be subject to the requirements 
under subsections (a) through (i) and subsection 
(n) in an applicable calendar year; and
201 
‘‘(B) shall submit to the Secretary— 
‘‘(i)(I) 
documentation 
that 
dem-
onstrates that the owner, operator, or agent 
in charge of the facility has identified po-
tential hazards associated with the food 
being produced, is implementing preventive 
controls to address the hazards, and is mon-
itoring the preventive controls to ensure 
that such controls are effective; or 
‘‘(II) documentation (which may in-
clude licenses, inspection reports, certifi-
cates, permits, credentials, certification by 
an appropriate agency (such as a State de-
partment of agriculture), or other evidence 
of oversight), as specified by the Secretary, 
that the facility is in compliance with 
State, local, county, or other applicable 
non-Federal food safety law; and 
‘‘(ii) documentation, as specified by the 
Secretary in a guidance document issued 
not later than 1 year after the date of enact-
ment of this section, that the facility is a 
qualified facility under paragraph (1)(B) or 
(1)(C). 
‘‘(3) WITHDRAWAL; RULE OF CONSTRUCTION.—
203 
‘‘(ii) a restaurant or retail food estab-
lishment (as those terms are defined by the 
Secretary for purposes of section 415) 
that— 
‘‘(I) is located— 
‘‘(aa) in the same State as 
the qualified facility that sold the 
food to such restaurant or estab-
lishment; or 
‘‘(bb) not more than 275 
miles from such facility; and 
‘‘(II) is purchasing the food for 
sale directly to consumers at such res-
taurant or retail food establishment. 
‘‘(C) CONSUMER.—For purposes of subpara-
graph (B), the term ‘consumer’ does not include 
a business. 
‘‘(D) SUBSIDIARY.—The term ‘subsidiary’ 
means any company which is owned or con-
trolled directly or indirectly by another com-
pany. 
‘‘(5) STUDY.— 
‘‘(A) IN GENERAL.—The Secretary, in con-
sultation with the Secretary of Agriculture, shall
204 
conduct a study of the food processing sector reg-
ulated by the Secretary to determine— 
‘‘(i) the distribution of food production 
by type and size of operation, including 
monetary value of food sold; 
‘‘(ii) the proportion of food produced 
by each type and size of operation; 
‘‘(iii) the number and types of food fa-
cilities co-located on farms, including the 
number and proportion by commodity and 
by manufacturing or processing activity; 
‘‘(iv) the incidence of foodborne illness 
originating from each size and type of oper-
ation and the type of food facilities for 
which no reported or known hazard exists; 
and 
‘‘(v) the effect on foodborne illness risk 
associated with commingling, processing, 
transporting, and storing food and raw ag-
ricultural 
commodities, 
including 
dif-
ferences in risk based on the scale and dura-
tion of such activities. 
‘‘(B) SIZE.—The results of the study con-
ducted under subparagraph (A) shall include the 
information necessary to enable the Secretary to
205 
define the terms ‘small business’ and ‘very small 
business’, for purposes of promulgating the regu-
lation under subsection (n). In defining such 
terms, the Secretary shall include consideration 
of harvestable acres, income, the number of em-
ployees, and the volume of food harvested. 
‘‘(C) SUBMISSION
OF
REPORT.—Not later 
than 18 months after the date of enactment the 
FDA Food Safety Modernization Act, the Sec-
retary shall submit to Congress a report that de-
scribes the results of the study conducted under 
subparagraph (A). 
‘‘(6) NO
PREEMPTION.—Nothing in this sub-
section preempts State, local, county, or other non- 
Federal law regarding the safe production of food. 
Compliance with this subsection shall not relieve any 
person from liability at common law or under State 
statutory law. 
‘‘(7) NOTIFICATION TO CONSUMERS.— 
‘‘(A) IN GENERAL.—A qualified facility that 
is exempt from the requirements under sub-
sections (a) through (i) and subsection (n) and 
does not prepare documentation under para-
graph (2)(B)(i)(I) shall—
206 
‘‘(i) with respect to a food for which a 
food packaging label is required by the Sec-
retary under any other provision of this 
Act, include prominently and conspicuously 
on such label the name and business address 
of the facility where the food was manufac-
tured or processed; or 
‘‘(ii) with respect to a food for which 
a food packaging label is not required by 
the Secretary under any other provisions of 
this Act, prominently and conspicuously 
display, at the point of purchase, the name 
and business address of the facility where 
the food was manufactured or processed, on 
a label, poster, sign, placard, or documents 
delivered contemporaneously with the food 
in the normal course of business, or, in the 
case of Internet sales, in an electronic no-
tice. 
‘‘(B) NO
ADDITIONAL
LABEL.—Subpara-
graph (A) does not provide authority to the Sec-
retary to require a label that is in addition to 
any label required under any other provision of 
this Act.
207 
‘‘(m) AUTHORITY WITH RESPECT TO CERTAIN FACILI-
TIES.—The Secretary may, by regulation, exempt or modify 
the requirements for compliance under this section with re-
spect to facilities that are solely engaged in the production 
of food for animals other than man, the storage of raw agri-
cultural commodities (other than fruits and vegetables) in-
tended for further distribution or processing, or the storage 
of packaged foods that are not exposed to the environment. 
‘‘(n) REGULATIONS.— 
‘‘(1) IN GENERAL.—Not later than 18 months 
after the date of enactment of the FDA Food Safety 
Modernization Act, the Secretary shall promulgate 
regulations— 
‘‘(A) to establish science-based minimum 
standards for conducting a hazard analysis, doc-
umenting hazards, implementing preventive con-
trols, and documenting the implementation of 
the preventive controls under this section; and 
‘‘(B) to define, for purposes of this section, 
the terms ‘small business’ and ‘very small busi-
ness’, taking into consideration the study de-
scribed in subsection (l)(5). 
‘‘(2) COORDINATION.—In promulgating the regu-
lations under paragraph (1)(A), with regard to haz-
ards that may be intentionally introduced, including
208 
by acts of terrorism, the Secretary shall coordinate 
with the Secretary of Homeland Security, as appro-
priate. 
‘‘(3) CONTENT.—The regulations promulgated 
under paragraph (1)(A) shall— 
‘‘(A) provide sufficient flexibility to be prac-
ticable for all sizes and types of facilities, includ-
ing small businesses such as a small food proc-
essing facility co-located on a farm; 
‘‘(B) comply with chapter 35 of title 44, 
United States Code (commonly known as the 
‘Paperwork Reduction Act’), with special atten-
tion to minimizing the burden (as defined in sec-
tion 3502(2) of such Act) on the facility, and col-
lection of information (as defined in section 
3502(3) of such Act), associated with such regu-
lations; 
‘‘(C) acknowledge differences in risk and 
minimize, as appropriate, the number of sepa-
rate standards that apply to separate foods; and 
‘‘(D) not require a facility to hire a consult-
ant or other third party to identify, implement, 
certify, or audit preventative controls, except in 
the case of negotiated enforcement resolutions
209 
that may require such a consultant or third 
party. 
‘‘(4) RULE OF CONSTRUCTION.—Nothing in this 
subsection shall be construed to provide the Secretary 
with the authority to prescribe specific technologies, 
practices, or critical controls for an individual facil-
ity. 
‘‘(5) REVIEW.—In promulgating the regulations 
under paragraph (1)(A), the Secretary shall review 
regulatory hazard analysis and preventive control 
programs in existence on the date of enactment of the 
FDA Food Safety Modernization Act, including the 
Grade ‘A’ Pasteurized Milk Ordinance to ensure that 
such regulations are consistent, to the extent prac-
ticable, with applicable domestic and internationally 
recognized standards in existence on such date. 
‘‘(o) DEFINITIONS.—For purposes of this section: 
‘‘(1) CRITICAL CONTROL POINT.—The term ‘crit-
ical control point’ means a point, step, or procedure 
in a food process at which control can be applied and 
is essential to prevent or eliminate a food safety haz-
ard or reduce such hazard to an acceptable level. 
‘‘(2) FACILITY.—The term ‘facility’ means a do-
mestic facility or a foreign facility that is required to 
register under section 415.
210 
‘‘(3) PREVENTIVE CONTROLS.—The term ‘preven-
tive controls’ means those risk-based, reasonably ap-
propriate procedures, practices, and processes that a 
person knowledgeable about the safe manufacturing, 
processing, packing, or holding of food would employ 
to significantly minimize or prevent the hazards iden-
tified under the hazard analysis conducted under sub-
section (b) and that are consistent with the current 
scientific understanding of safe food manufacturing, 
processing, packing, or holding at the time of the 
analysis. Those procedures, practices, and processes 
may include the following: 
‘‘(A) Sanitation procedures for food contact 
surfaces and utensils and food-contact surfaces of 
equipment. 
‘‘(B) Supervisor, manager, and employee 
hygiene training. 
‘‘(C) An environmental monitoring pro-
gram to verify the effectiveness of pathogen con-
trols in processes where a food is exposed to a po-
tential contaminant in the environment. 
‘‘(D) A food allergen control program. 
‘‘(E) A recall plan.
211 
‘‘(F) Current Good Manufacturing Practices 
(cGMPs) under part 110 of title 21, Code of Fed-
eral Regulations (or any successor regulations). 
‘‘(G) Supplier verification activities that re-
late to the safety of food.’’. 
(b) GUIDANCE DOCUMENT.—The Secretary shall issue 
a guidance document related to the regulations promulgated 
under subsection (b)(1) with respect to the hazard analysis 
and preventive controls under section 418 of the Federal 
Food, Drug, and Cosmetic Act (as added by subsection (a)). 
(c) RULEMAKING.— 
(1) PROPOSED RULEMAKING.— 
(A) IN GENERAL.—Not later than 9 months 
after the date of enactment of this Act, the Sec-
retary of Health and Human Services (referred 
to in this subsection as the ‘‘Secretary’’) shall 
publish a notice of proposed rulemaking in the 
Federal Register to promulgate regulations with 
respect to— 
(i) activities that constitute on-farm 
packing or holding of food that is not 
grown, raised, or consumed on such farm or 
another farm under the same ownership for 
purposes of section 415 of the Federal Food,
212 
Drug, and Cosmetic Act (21 U.S.C. 350d), 
as amended by this Act; and 
(ii) activities that constitute on-farm 
manufacturing or processing of food that is 
not consumed on that farm or on another 
farm under common ownership for purposes 
of such section 415. 
(B) CLARIFICATION.—The rulemaking de-
scribed under subparagraph (A) shall enhance 
the implementation of such section 415 and clar-
ify the activities that are included as part of the 
definition of the term ‘‘facility’’ under such sec-
tion 415. Nothing in this Act authorizes the Sec-
retary to modify the definition of the term ‘‘facil-
ity’’ under such section. 
(C) SCIENCE-BASED
RISK
ANALYSIS.—In 
promulgating regulations under subparagraph 
(A), the Secretary shall conduct a science-based 
risk analysis of— 
(i) specific types of on-farm packing or 
holding of food that is not grown, raised, or 
consumed on such farm or another farm 
under the same ownership, as such packing 
and holding relates to specific foods; and
213 
(ii) specific on-farm manufacturing 
and processing activities as such activities 
relate to specific foods that are not con-
sumed on that farm or on another farm 
under common ownership. 
(D) AUTHORITY WITH RESPECT TO CERTAIN 
FACILITIES.— 
(i) IN GENERAL.—In promulgating the 
regulations under subparagraph (A), the 
Secretary shall consider the results of the 
science-based risk analysis conducted under 
subparagraph (C), and shall exempt certain 
facilities from the requirements in section 
418 of the Federal Food, Drug, and Cos-
metic Act (as added by this section), includ-
ing hazard analysis and preventive controls, 
and the mandatory inspection frequency in 
section 421 of such Act (as added by section 
6201), or modify the requirements in such 
sections 418 or 421, as the Secretary deter-
mines appropriate, if such facilities are en-
gaged only in specific types of on-farm 
manufacturing, 
processing, 
packing, 
or 
holding activities that the Secretary deter-
214 
mines to be low risk involving specific foods 
the Secretary determines to be low risk. 
(ii) LIMITATION.—The exemptions or 
modifications under clause (i) shall not in-
clude an exemption from the requirement to 
register under section 415 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
350d), as amended by this Act, if applica-
ble, and shall apply only to small businesses 
and very small businesses, as defined in the 
regulation 
promulgated 
under 
section 
418(n) of the Federal Food, Drug, and Cos-
metic Act (as added under subsection (a)). 
(2) FINAL
REGULATIONS.—Not later than 9 
months after the close of the comment period for the 
proposed rulemaking under paragraph (1), the Sec-
retary shall adopt final rules with respect to— 
(A) activities that constitute on-farm pack-
ing or holding of food that is not grown, raised, 
or consumed on such farm or another farm 
under the same ownership for purposes of section 
415 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 350d), as amended by this Act; 
(B) activities that constitute on-farm manu-
facturing or processing of food that is not con-
215 
sumed on that farm or on another farm under 
common ownership for purposes of such section 
415; and 
(C) the requirements under sections 418 and 
421 of the Federal Food, Drug, and Cosmetic 
Act, as added by this Act, from which the Sec-
retary may issue exemptions or modifications of 
the requirements for certain types of facilities. 
(d) SMALL ENTITY COMPLIANCE POLICY GUIDE.—Not 
later than 180 days after the issuance of the regulations 
promulgated under subsection (n) of section 418 of the Fed-
eral Food, Drug, and Cosmetic Act (as added by subsection 
(a)), the Secretary shall issue a small entity compliance 
policy guide setting forth in plain language the require-
ments of such section 418 and this section to assist small 
entities in complying with the hazard analysis and other 
activities required under such section 418 and this section. 
(e) PROHIBITED ACTS.—Section 301 (21 U.S.C. 331) 
is amended by adding at the end the following: 
‘‘(uu) The operation of a facility that manufactures, 
processes, packs, or holds food for sale in the United States 
if the owner, operator, or agent in charge of such facility 
is not in compliance with section 418.’’. 
(f) NO EFFECT ON HACCP AUTHORITIES.—Nothing 
in the amendments made by this section limits the author-
216 
ity of the Secretary under the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 301 et seq.) or the Public Health Serv-
ice Act (42 U.S.C. 201 et seq.) to revise, issue, or enforce 
Hazard Analysis Critical Control programs and the Ther-
mally Processed Low-Acid Foods Packaged in Hermetically 
Sealed Containers standards. 
(g) DIETARY SUPPLEMENTS.—Nothing in the amend-
ments made by this section shall apply to any facility with 
regard to the manufacturing, processing, packing, or hold-
ing of a dietary supplement that is in compliance with the 
requirements of sections 402(g)(2) and 761 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 342(g)(2), 379aa– 
1). 
(h) UPDATING GUIDANCE RELATING TO FISH AND 
FISHERIES PRODUCTS HAZARDS
AND CONTROLS.—The 
Secretary shall, not later than 180 days after the date of 
enactment of this Act, update the Fish and Fisheries Prod-
ucts Hazards and Control Guidance to take into account 
advances in technology that have occurred since the pre-
vious publication of such Guidance by the Secretary. 
(i) EFFECTIVE DATES.— 
(1) GENERAL RULE.—The amendments made by 
this section shall take effect 18 months after the date 
of enactment of this Act.
217 
(2) FLEXIBILITY FOR SMALL BUSINESSES.—Not-
withstanding paragraph (1)— 
(A) the amendments made by this section 
shall apply to a small business (as defined in the 
regulations promulgated under section 418(n) of 
the Federal Food, Drug, and Cosmetic Act (as 
added by this section)) beginning on the date 
that is 6 months after the effective date of such 
regulations; and 
(B) the amendments made by this section 
shall apply to a very small business (as defined 
in such regulations) beginning on the date that 
is 18 months after the effective date of such regu-
lations. 
SEC. 6104. PERFORMANCE STANDARDS. 
(a) IN GENERAL.—The Secretary shall, in coordina-
tion with the Secretary of Agriculture, not less frequently 
than every 2 years, review and evaluate relevant health data 
and other relevant information, including from toxi-
cological and epidemiological studies and analyses, current 
Good Manufacturing Practices issued by the Secretary re-
lating to food, and relevant recommendations of relevant 
advisory committees, including the Food Advisory Com-
mittee, to determine the most significant foodborne contami-
nants.
218 
(b) GUIDANCE DOCUMENTS
AND REGULATIONS.— 
Based on the review and evaluation conducted under sub-
section (a), and when appropriate to reduce the risk of seri-
ous illness or death to humans or animals or to prevent 
adulteration of the food under section 402 of the Federal 
Food, Drug, or Cosmetic Act (21 U.S.C. 342) or to prevent 
the spread by food of communicable disease under section 
361 of the Public Health Service Act (42 U.S.C. 264), the 
Secretary shall issue contaminant-specific and science- 
based guidance documents, including guidance documents 
regarding action levels, or regulations. Such guidance, in-
cluding guidance regarding action levels, or regulations— 
(1) shall apply to products or product classes; 
(2) shall, where appropriate, differentiate be-
tween food for human consumption and food intended 
for consumption by animals other than humans; and 
(3) shall not be written to be facility-specific. 
(c) NO DUPLICATION OF EFFORTS.—The Secretary 
shall coordinate with the Secretary of Agriculture to avoid 
issuing duplicative guidance on the same contaminants. 
(d) REVIEW.—The Secretary shall periodically review 
and revise, as appropriate, the guidance documents, includ-
ing guidance documents regarding action levels, or regula-
tions promulgated under this section.
219 
SEC. 6105. STANDARDS FOR PRODUCE SAFETY. 
(a) IN GENERAL.—Chapter IV (21 U.S.C. 341 et seq.), 
as amended by section 6103, is amended by adding at the 
end the following: 
‘‘SEC. 419. STANDARDS FOR PRODUCE SAFETY. 
‘‘(a) PROPOSED RULEMAKING.— 
‘‘(1) IN GENERAL.— 
‘‘(A) RULEMAKING.—Not later than 1 year 
after the date of enactment of the FDA Food 
Safety Modernization Act, the Secretary, in co-
ordination with the Secretary of Agriculture and 
representatives of State departments of agri-
culture (including with regard to the national 
organic program established under the Organic 
Foods Production Act of 1990), and in consulta-
tion with the Secretary of Homeland Security, 
shall publish a notice of proposed rulemaking to 
establish science-based minimum standards for 
the safe production and harvesting of those types 
of fruits and vegetables, including specific mixes 
or categories of fruits and vegetables, that are 
raw agricultural commodities for which the Sec-
retary has determined that such standards mini-
mize the risk of serious adverse health con-
sequences or death.
221 
tables that are raw agricultural commodities, in-
cluding small businesses and entities that sell di-
rectly to consumers, and be appropriate to the 
scale and diversity of the production and har-
vesting of such commodities; 
‘‘(B) include, with respect to growing, har-
vesting, sorting, packing, and storage operations, 
science-based minimum standards related to soil 
amendments, hygiene, packaging, temperature 
controls, animals in the growing area, and 
water; 
‘‘(C) consider hazards that occur naturally, 
may be unintentionally introduced, or may be 
intentionally introduced, including by acts of 
terrorism; 
‘‘(D) take into consideration, consistent 
with ensuring enforceable public health protec-
tion, conservation and environmental practice 
standards and policies established by Federal 
natural resource conservation, wildlife conserva-
tion, and environmental agencies; 
‘‘(E) in the case of production that is cer-
tified organic, not include any requirements that 
conflict with or duplicate the requirements of the 
national organic program established under the
222 
Organic Foods Production Act of 1990, while 
providing the same level of public health protec-
tion as the requirements under guidance docu-
ments, including guidance documents regarding 
action levels, and regulations under the FDA 
Food Safety Modernization Act; and 
‘‘(F) define, for purposes of this section, the 
terms ‘small business’ and ‘very small business’. 
‘‘(4) 
PRIORITIZATION.—The 
Secretary 
shall 
prioritize the implementation of the regulations under 
this section for specific fruits and vegetables that are 
raw agricultural commodities based on known risks 
which may include a history and severity of 
foodborne illness outbreaks. 
‘‘(b) FINAL REGULATION.— 
‘‘(1) IN GENERAL.—Not later than 1 year after 
the close of the comment period for the proposed rule-
making under subsection (a), the Secretary shall 
adopt a final regulation to provide for minimum 
science-based standards for those types of fruits and 
vegetables, including specific mixes or categories of 
fruits or vegetables, that are raw agricultural com-
modities, based on known safety risks, which may in-
clude a history of foodborne illness outbreaks.
223 
‘‘(2) FINAL REGULATION.—The final regulation 
shall— 
‘‘(A) provide for coordination of education 
and enforcement activities by State and local of-
ficials, as designated by the Governors of the re-
spective States or the appropriate elected State 
official as recognized by State statute; and 
‘‘(B) include a description of the variance 
process under subsection (c) and the types of per-
missible variances the Secretary may grant. 
‘‘(3) FLEXIBILITY
FOR
SMALL
BUSINESSES.— 
Notwithstanding paragraph (1)— 
‘‘(A) the regulations promulgated under this 
section shall apply to a small business (as de-
fined in the regulation promulgated under sub-
section (a)(1)) after the date that is 1 year after 
the effective date of the final regulation under 
paragraph (1); and 
‘‘(B) the regulations promulgated under this 
section shall apply to a very small business (as 
defined in the regulation promulgated under sub-
section (a)(1)) after the date that is 2 years after 
the effective date of the final regulation under 
paragraph (1). 
‘‘(c) CRITERIA.—
224 
‘‘(1) IN
GENERAL.—The regulations adopted 
under subsection (b) shall— 
‘‘(A) set forth those procedures, processes, 
and practices that the Secretary determines to 
minimize the risk of serious adverse health con-
sequences or death, including procedures, proc-
esses, and practices that the Secretary determines 
to be reasonably necessary to prevent the intro-
duction of known or reasonably foreseeable bio-
logical, chemical, and physical hazards, includ-
ing hazards that occur naturally, may be unin-
tentionally introduced, or may be intentionally 
introduced, including by acts of terrorism, into 
fruits and vegetables, including specific mixes or 
categories of fruits and vegetables, that are raw 
agricultural commodities and to provide reason-
able assurances that the produce is not adulter-
ated under section 402; 
‘‘(B) provide sufficient flexibility to be 
practicable for all sizes and types of businesses, 
including small businesses such as a small food 
processing facility co-located on a farm; 
‘‘(C) comply with chapter 35 of title 44, 
United States Code (commonly known as the 
‘Paperwork Reduction Act’), with special atten-
225 
tion to minimizing the burden (as defined in sec-
tion 3502(2) of such Act) on the business, and 
collection of information (as defined in section 
3502(3) of such Act), associated with such regu-
lations; 
‘‘(D) acknowledge differences in risk and 
minimize, as appropriate, the number of sepa-
rate standards that apply to separate foods; and 
‘‘(E) not require a business to hire a con-
sultant or other third party to identify, imple-
ment, or certify compliance with these proce-
dures, processes, and practices, except in the case 
of negotiated enforcement resolutions that may 
require such a consultant or third party; and 
‘‘(F) permit States and foreign countries 
from which food is imported into the United 
States to request from the Secretary variances 
from the requirements of the regulations, subject 
to paragraph (2), where the State or foreign 
country determines that the variance is necessary 
in light of local growing conditions and that the 
procedures, processes, and practices to be fol-
lowed under the variance are reasonably likely to 
ensure that the produce is not adulterated under 
section 402 and to provide the same level of pub-
226 
lic health protection as the requirements of the 
regulations adopted under subsection (b). 
‘‘(2) VARIANCES.— 
‘‘(A) REQUESTS FOR VARIANCES.—A State 
or foreign country from which food is imported 
into the United States may in writing request a 
variance from the Secretary. Such request shall 
describe the variance requested and present in-
formation demonstrating that the variance does 
not increase the likelihood that the food for which 
the variance is requested will be adulterated 
under section 402, and that the variance pro-
vides the same level of public health protection as 
the requirements of the regulations adopted 
under subsection (b). The Secretary shall review 
such requests in a reasonable timeframe. 
‘‘(B) APPROVAL OF VARIANCES.—The Sec-
retary may approve a variance in whole or in 
part, as appropriate, and may specify the scope 
of applicability of a variance to other similarly 
situated persons. 
‘‘(C) DENIAL
OF
VARIANCES.—The Sec-
retary may deny a variance request if the Sec-
retary determines that such variance is not rea-
sonably likely to ensure that the food is not adul-
230 
on such label the name and business address 
of the farm where the produce was grown; 
or 
‘‘(ii) with respect to a food for which 
a food packaging label is not required by 
the Secretary under any other provision of 
this Act, prominently and conspicuously 
display, at the point of purchase, the name 
and business address of the farm where the 
produce was grown, on a label, poster, sign, 
placard, or document delivered contempora-
neously with the food in the normal course 
of business, or, in the case of Internet sales, 
in an electronic notice. 
‘‘(B) NO
ADDITIONAL
LABEL.—Subpara-
graph (A) does not provide authority to the Sec-
retary to require a label that is in addition to 
any label required under any other provision of 
this Act. 
‘‘(3) WITHDRAWAL; RULE OF CONSTRUCTION.— 
‘‘(A) IN GENERAL.—In the event of an ac-
tive investigation of a foodborne illness outbreak 
that is directly linked to a farm subject to an ex-
emption under this subsection, or if the Sec-
retary determines that it is necessary to protect
231 
the public health and prevent or mitigate a 
foodborne illness outbreak based on conduct or 
conditions associated with a farm that are mate-
rial to the safety of the food produced or har-
vested at such farm, the Secretary may withdraw 
the exemption provided to such farm under this 
subsection. 
‘‘(B) RULE OF CONSTRUCTION.—Nothing in 
this subsection shall be construed to expand or 
limit the inspection authority of the Secretary. 
‘‘(4) DEFINITIONS.— 
‘‘(A) QUALIFIED END-USER.—In this sub-
section, the term ‘qualified end-user’, with re-
spect to a food means— 
‘‘(i) the consumer of the food; or 
‘‘(ii) a restaurant or retail food estab-
lishment (as those terms are defined by the 
Secretary for purposes of section 415) that 
is located— 
‘‘(I) in the same State as the farm 
that produced the food; or 
‘‘(II) not more than 275 miles 
from such farm.
232 
‘‘(B) CONSUMER.—For purposes of subpara-
graph (A), the term ‘consumer’ does not include 
a business. 
‘‘(5) NO
PREEMPTION.—Nothing in this sub-
section preempts State, local, county, or other non- 
Federal law regarding the safe production, harvesting, 
holding, transportation, and sale of fresh fruits and 
vegetables. Compliance with this subsection shall not 
relieve any person from liability at common law or 
under State statutory law. 
‘‘(6) LIMITATION OF EFFECT.—Nothing in this 
subsection shall prevent the Secretary from exercising 
any authority granted in the other sections of this 
Act. 
‘‘(g) CLARIFICATION.—This section shall not apply to 
produce that is produced by an individual for personal con-
sumption. 
‘‘(h) EXCEPTION FOR ACTIVITIES OF FACILITIES SUB-
JECT TO SECTION 418.—This section shall not apply to ac-
tivities of a facility that are subject to section 418.’’. 
(b) SMALL ENTITY COMPLIANCE POLICY GUIDE.—Not 
later than 180 days after the issuance of regulations under 
section 419 of the Federal Food, Drug, and Cosmetic Act 
(as added by subsection (a)), the Secretary of Health and 
Human Services shall issue a small entity compliance pol-
233 
icy guide setting forth in plain language the requirements 
of such section 419 and to assist small entities in complying 
with standards for safe production and harvesting and 
other activities required under such section. 
(c) PROHIBITED ACTS.—Section 301 (21 U.S.C. 331), 
as amended by section 6103, is amended by adding at the 
end the following: 
‘‘(vv) The failure to comply with the requirements 
under section 419.’’. 
(d) NO EFFECT ON HACCP AUTHORITIES.—Nothing 
in the amendments made by this section limits the author-
ity of the Secretary under the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 301 et seq.) or the Public Health Serv-
ice Act (42 U.S.C. 201 et seq.) to revise, issue, or enforce 
product and category-specific regulations, such as the Sea-
food Hazard Analysis Critical Controls Points Program, 
the Juice Hazard Analysis Critical Control Program, and 
the Thermally Processed Low-Acid Foods Packaged in Her-
metically Sealed Containers standards. 
SEC. 6106. PROTECTION AGAINST INTENTIONAL ADULTERA-
TION. 
(a) IN GENERAL.—Chapter IV (21 U.S.C. 341 et seq.), 
as amended by section 6105, is amended by adding at the 
end the following:
234 
‘‘SEC. 420. PROTECTION AGAINST INTENTIONAL ADULTERA-
TION. 
‘‘(a) DETERMINATIONS.— 
‘‘(1) IN GENERAL.—The Secretary shall— 
‘‘(A) conduct a vulnerability assessment of 
the food system, including by consideration of 
the Department of Homeland Security biological, 
chemical, radiological, or other terrorism risk as-
sessments; 
‘‘(B) consider the best available under-
standing of uncertainties, risks, costs, and bene-
fits associated with guarding against intentional 
adulteration of food at vulnerable points; and 
‘‘(C) determine the types of science-based 
mitigation strategies or measures that are nec-
essary to protect against the intentional adulter-
ation of food. 
‘‘(2) LIMITED DISTRIBUTION.—In the interest of 
national security, the Secretary, in consultation with 
the Secretary of Homeland Security, may determine 
the time, manner, and form in which determinations 
made under paragraph (1) are made publicly avail-
able. 
‘‘(b) REGULATIONS.—Not later than 18 months after 
the date of enactment of the FDA Food Safety Moderniza-
tion Act, the Secretary, in coordination with the Secretary
235 
of Homeland Security and in consultation with the Sec-
retary of Agriculture, shall promulgate regulations to pro-
tect against the intentional adulteration of food subject to 
this Act. Such regulations shall— 
‘‘(1) specify how a person shall assess whether 
the person is required to implement mitigation strate-
gies or measures intended to protect against the in-
tentional adulteration of food; and 
‘‘(2) specify appropriate science-based mitigation 
strategies or measures to prepare and protect the food 
supply chain at specific vulnerable points, as appro-
priate. 
‘‘(c) APPLICABILITY.—Regulations promulgated under 
subsection (b) shall apply only to food for which there is 
a high risk of intentional contamination, as determined by 
the Secretary, in consultation with the Secretary of Home-
land Security, under subsection (a), that could cause serious 
adverse health consequences or death to humans or animals 
and shall include those foods— 
‘‘(1) for which the Secretary has identified clear 
vulnerabilities (including short shelf-life or suscepti-
bility to intentional contamination at critical control 
points); and 
‘‘(2) in bulk or batch form, prior to being pack-
aged for the final consumer.
236 
‘‘(d) EXCEPTION.—This section shall not apply to 
farms, except for those that produce milk. 
‘‘(e) DEFINITION.—For purposes of this section, the 
term ‘farm’ has the meaning given that term in section 
1.227 of title 21, Code of Federal Regulations (or any suc-
cessor regulation).’’. 
(b) GUIDANCE DOCUMENTS.— 
(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of this Act, the Secretary of 
Health and Human Services, in consultation with the 
Secretary of Homeland Security and the Secretary of 
Agriculture, shall issue guidance documents related to 
protection against the intentional adulteration of 
food, including mitigation strategies or measures to 
guard against such adulteration as required under 
section 420 of the Federal Food, Drug, and Cosmetic 
Act, as added by subsection (a). 
(2) CONTENT.—The guidance documents issued 
under paragraph (1) shall— 
(A) include a model assessment for a person 
to use under subsection (b)(1) of section 420 of 
the Federal Food, Drug, and Cosmetic Act, as 
added by subsection (a);
237 
(B) include examples of mitigation strate-
gies or measures described in subsection (b)(2) of 
such section; and 
(C) specify situations in which the examples 
of mitigation strategies or measures described in 
subsection (b)(2) of such section are appropriate. 
(3) LIMITED DISTRIBUTION.—In the interest of 
national security, the Secretary of Health and 
Human Services, in consultation with the Secretary 
of Homeland Security, may determine the time, man-
ner, and form in which the guidance documents 
issued under paragraph (1) are made public, includ-
ing by releasing such documents to targeted audi-
ences. 
(c) PERIODIC REVIEW.—The Secretary of Health and 
Human Services shall periodically review and, as appro-
priate, update the regulations under section 420(b) of the 
Federal Food, Drug, and Cosmetic Act, as added by sub-
section (a), and the guidance documents under subsection 
(b). 
(d) PROHIBITED ACTS.—Section 301 (21 U.S.C. 331 
et seq.), as amended by section 6105, is amended by adding 
at the end the following: 
‘‘(ww) The failure to comply with section 420.’’.
238 
SEC. 6107. AUTHORITY TO COLLECT FEES. 
(a) FEES FOR REINSPECTION, RECALL, AND IMPORTA-
TION ACTIVITIES.—Subchapter C of chapter VII (21 U.S.C. 
379f et seq.) is amended by adding at the end the following: 
‘‘PART 6—FEES RELATED TO FOOD 
‘‘SEC. 743. AUTHORITY TO COLLECT AND USE FEES. 
‘‘(a) IN GENERAL.— 
‘‘(1) PURPOSE AND AUTHORITY.—For fiscal year 
2010 and each subsequent fiscal year, the Secretary 
shall, in accordance with this section, assess and col-
lect fees from— 
‘‘(A) the responsible party for each domestic 
facility (as defined in section 415(b)) and the 
United States agent for each foreign facility sub-
ject to a reinspection in such fiscal year, to cover 
reinspection-related costs for such year; 
‘‘(B) the responsible party for a domestic 
facility (as defined in section 415(b)) and an 
importer who does not comply with a recall 
order under section 423 or under section 412(f) 
in such fiscal year, to cover food recall activities 
associated with such order performed by the Sec-
retary, including technical assistance, follow-up 
effectiveness checks, and public notifications, for 
such year;
239 
‘‘(C) each importer participating in the vol-
untary qualified importer program under section 
806 in such year, to cover the administrative 
costs of such program for such year; and 
‘‘(D) each importer subject to a reinspection 
in such fiscal year, to cover reinspection-related 
costs for such year. 
‘‘(2) DEFINITIONS.—For purposes of this sec-
tion— 
‘‘(A) the term ‘reinspection’ means— 
‘‘(i) with respect to domestic facilities 
(as defined in section 415(b)), 1 or more in-
spections conducted under section 704 subse-
quent to an inspection conducted under 
such provision which identified noncompli-
ance materially related to a food safety re-
quirement of this Act, specifically to deter-
mine whether compliance has been achieved 
to the Secretary’s satisfaction; and 
‘‘(ii) with respect to importers, 1 or 
more examinations conducted under section 
801 subsequent to an examination con-
ducted under such provision which identi-
fied noncompliance materially related to a 
food safety requirement of this Act, specifi-
240 
cally to determine whether compliance has 
been achieved to the Secretary’s satisfaction; 
‘‘(B) the term ‘reinspection-related costs’ 
means all expenses, including administrative ex-
penses, incurred in connection with— 
‘‘(i) arranging, conducting, and evalu-
ating the results of reinspections; and 
‘‘(ii) assessing and collecting reinspec-
tion fees under this section; and 
‘‘(C) the term ‘responsible party’ has the 
meaning given such term in section 417(a)(1). 
‘‘(b) ESTABLISHMENT OF FEES.— 
‘‘(1) IN
GENERAL.—Subject to subsections (c) 
and (d), the Secretary shall establish the fees to be col-
lected under this section for each fiscal year specified 
in subsection (a)(1), based on the methodology de-
scribed under paragraph (2), and shall publish such 
fees in a Federal Register notice not later than 60 
days before the start of each such year. 
‘‘(2) FEE METHODOLOGY.— 
‘‘(A) FEES.—Fees amounts established for 
collection— 
‘‘(i) under subparagraph (A) of sub-
section (a)(1) for a fiscal year shall be based 
on the Secretary’s estimate of 100 percent of
241 
the costs of the reinspection-related activi-
ties (including by type or level of reinspec-
tion activity, as the Secretary determines 
applicable) described in such subparagraph 
(A) for such year; 
‘‘(ii) under subparagraph (B) of sub-
section (a)(1) for a fiscal year shall be based 
on the Secretary’s estimate of 100 percent of 
the costs of the activities described in such 
subparagraph (B) for such year; 
‘‘(iii) under subparagraph (C) of sub-
section (a)(1) for a fiscal year shall be based 
on the Secretary’s estimate of 100 percent of 
the costs of the activities described in such 
subparagraph (C) for such year; and 
‘‘(iv) under subparagraph (D) of sub-
section (a)(1) for a fiscal year shall be based 
on the Secretary’s estimate of 100 percent of 
the costs of the activities described in such 
subparagraph (D) for such year. 
‘‘(B) OTHER CONSIDERATIONS.— 
‘‘(i) VOLUNTARY QUALIFIED IMPORTER 
PROGRAM.—In establishing the fee amounts 
under subparagraph (A)(iii) for a fiscal 
year, the Secretary shall provide for the
242 
number of importers who have submitted to 
the Secretary a notice under section 806(c) 
informing the Secretary of the intent of 
such importer to participate in the program 
under section 806 in such fiscal year. 
‘‘(ii) CREDITING OF FEES.—In estab-
lishing the fee amounts under subparagraph 
(A) for a fiscal year, the Secretary shall 
provide for the crediting of fees from the 
previous year to the next year if the Sec-
retary overestimated the amount of fees 
needed to carry out such activities, and con-
sider the need to account for any adjust-
ment of fees and such other factors as the 
Secretary determines appropriate. 
‘‘(iii) PUBLISHED
GUIDELINES.—Not 
later than 180 days after the date of enact-
ment of the FDA Food Safety Moderniza-
tion Act, the Secretary shall publish in the 
Federal Register a proposed set of guidelines 
in consideration of the burden of fee 
amounts on small business. Such consider-
ation may include reduced fee amounts for 
small businesses. The Secretary shall pro-
vide for a period of public comment on such
243 
guidelines. The Secretary shall adjust the fee 
schedule for small businesses subject to such 
fees only through notice and comment rule-
making. 
‘‘(3) USE OF FEES.—The Secretary shall make 
all of the fees collected pursuant to clause (i), (ii), 
(iii), and (iv) of paragraph (2)(A) available solely to 
pay for the costs referred to in such clause (i), (ii), 
(iii), and (iv) of paragraph (2)(A), respectively. 
‘‘(c) LIMITATIONS.— 
‘‘(1) IN
GENERAL.—Fees under subsection (a) 
shall be refunded for a fiscal year beginning after fis-
cal year 2010 unless the amount of the total appro-
priations for food safety activities at the Food and 
Drug Administration for such fiscal year (excluding 
the amount of fees appropriated for such fiscal year) 
is equal to or greater than the amount of appropria-
tions for food safety activities at the Food and Drug 
Administration for fiscal year 2009 (excluding the 
amount of fees appropriated for such fiscal year), 
multiplied by the adjustment factor under paragraph 
(3). 
‘‘(2) AUTHORITY.—If—
244 
‘‘(A) the Secretary does not assess fees under 
subsection (a) for a portion of a fiscal year be-
cause paragraph (1) applies; and 
‘‘(B) at a later date in such fiscal year, 
such paragraph (1) ceases to apply, 
the Secretary may assess and collect such fees under 
subsection (a), without any modification to the rate 
of such fees, notwithstanding the provisions of sub-
section (a) relating to the date fees are to be paid. 
‘‘(3) ADJUSTMENT FACTOR.— 
‘‘(A) IN GENERAL.—The adjustment factor 
described in paragraph (1) shall be the total per-
centage change that occurred in the Consumer 
Price Index for all urban consumers (all items; 
United States city average) for the 12-month pe-
riod ending June 30 preceding the fiscal year, 
but in no case shall such adjustment factor be 
negative. 
‘‘(B) COMPOUNDED BASIS.—The adjustment 
under subparagraph (A) made each fiscal year 
shall be added on a compounded basis to the sum 
of all adjustments made each fiscal year after fis-
cal year 2009. 
‘‘(4) LIMITATION
ON
AMOUNT
OF
CERTAIN 
FEES.—
245 
‘‘(A) IN
GENERAL.—Notwithstanding any 
other provision of this section and subject to sub-
paragraph (B), the Secretary may not collect fees 
in a fiscal year such that the amount collected— 
‘‘(i) under subparagraph (B) of sub-
section (a)(1) exceeds $20,000,000; and 
‘‘(ii) under subparagraphs (A) and (D) 
of subsection (a)(1) exceeds $25,000,000 
combined. 
‘‘(B) EXCEPTION.—If a domestic facility 
(as defined in section 415(b)) or an importer be-
comes subject to a fee described in subparagraph 
(A), (B), or (D) of subsection (a)(1) after the 
maximum amount of fees has been collected by 
the Secretary under subparagraph (A), the Sec-
retary may collect a fee from such facility or im-
porter. 
‘‘(d) CREDITING AND AVAILABILITY OF FEES.—Fees 
authorized under subsection (a) shall be collected and avail-
able for obligation only to the extent and in the amount 
provided in appropriations Acts. Such fees are authorized 
to remain available until expended. Such sums as may be 
necessary may be transferred from the Food and Drug Ad-
ministration salaries and expenses account without fiscal 
year limitation to such appropriation account for salaries
246 
and expenses with such fiscal year limitation. The sums 
transferred shall be available solely for the purpose of pay-
ing the operating expenses of the Food and Drug Adminis-
tration employees and contractors performing activities as-
sociated with these food safety fees. 
‘‘(e) COLLECTION OF FEES.— 
‘‘(1) IN GENERAL.—The Secretary shall specify 
in the Federal Register notice described in subsection 
(b)(1) the time and manner in which fees assessed 
under this section shall be collected. 
‘‘(2) COLLECTION
OF
UNPAID
FEES.—In any 
case where the Secretary does not receive payment of 
a fee assessed under this section within 30 days after 
it is due, such fee shall be treated as a claim of the 
United States Government subject to provisions of 
subchapter II of chapter 37 of title 31, United States 
Code. 
‘‘(f) ANNUAL REPORT TO CONGRESS.—Not later than 
120 days after each fiscal year for which fees are assessed 
under this section, the Secretary shall submit a report to 
the Committee on Health, Education, Labor, and Pensions 
of the Senate and the Committee on Energy and Commerce 
of the House of Representatives, to include a description 
of fees assessed and collected for each such year and a sum-
247 
mary description of the entities paying such fees and the 
types of business in which such entities engage. 
‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—For fis-
cal year 2010 and each fiscal year thereafter, there is au-
thorized to be appropriated for fees under this section an 
amount equal to the total revenue amount determined under 
subsection (b) for the fiscal year, as adjusted or otherwise 
affected under the other provisions of this section.’’. 
(b) EXPORT CERTIFICATION FEES FOR FOODS AND 
ANIMAL FEED.— 
(1) AUTHORITY
FOR
EXPORT
CERTIFICATIONS 
FOR
FOOD, 
INCLUDING
ANIMAL
FEED.—Section 
801(e)(4)(A) (21 U.S.C. 381(e)(4)(A)) is amended— 
(A) in the matter preceding clause (i), by 
striking ‘‘a drug’’ and inserting ‘‘a food, drug’’; 
(B) in clause (i) by striking ‘‘exported 
drug’’ and inserting ‘‘exported food, drug’’; and 
(C) in clause (ii) by striking ‘‘the drug’’ 
each place it appears and inserting ‘‘the food, 
drug’’. 
(2) CLARIFICATION OF CERTIFICATION.—Section 
801(e)(4) (21 U.S.C. 381(e)(4)) is amended by insert-
ing after subparagraph (B) the following new sub-
paragraph:
248 
‘‘(C) For purposes of this paragraph, a certification 
by the Secretary shall be made on such basis, and in such 
form (including a publicly available listing) as the Sec-
retary determines appropriate.’’. 
(3) LIMITATIONS
ON
USE
AND
AMOUNT
OF 
FEES.—Paragraph (4) of section 801(e) (21 U.S.C. 
381(e)) is amended by adding at the end the fol-
lowing: 
‘‘(D) With regard to fees pursuant to subparagraph 
(B) in connection with written export certifications for 
food: 
‘‘(i) Such fees shall be collected and available 
solely for the costs of the Food and Drug Administra-
tion associated with issuing such certifications. 
‘‘(ii) Such fees may not be retained in an 
amount that exceeds such costs.’’. 
SEC. 6108. NATIONAL AGRICULTURE AND FOOD DEFENSE 
STRATEGY. 
(a) DEVELOPMENT AND SUBMISSION OF STRATEGY.— 
(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of this Act, the Secretary of 
Health and Human Services and the Secretary of Ag-
riculture, in coordination with the Secretary of 
Homeland Security, shall prepare and transmit to the 
relevant committees of Congress, and make publicly
250 
(A) the National Incident Management Sys-
tem; 
(B) the National Response Framework; 
(C) the National Infrastructure Protection 
Plan; 
(D) the National Preparedness Goals; and 
(E) other relevant national strategies. 
(b) COMPONENTS.— 
(1) IN GENERAL.—The strategy shall include a 
description of the process to be used by the Depart-
ment of Health and Human Services, the Department 
of Agriculture, and the Department of Homeland Se-
curity— 
(A) to achieve each goal described in para-
graph (2); and 
(B) to evaluate the progress made by Fed-
eral, State, local, and tribal governments to-
wards the achievement of each goal described in 
paragraph (2). 
(2) GOALS.—The strategy shall include a de-
scription of the process to be used by the Department 
of Health and Human Services, the Department of 
Agriculture, and the Department of Homeland Secu-
rity to achieve the following goals:
251 
(A) PREPAREDNESS
GOAL.—Enhance the 
preparedness of the agriculture and food system 
by— 
(i) conducting vulnerability assess-
ments of the agriculture and food system; 
(ii) mitigating vulnerabilities of the 
system; 
(iii) improving communication and 
training relating to the system; 
(iv) developing and conducting exer-
cises to test decontamination and disposal 
plans; 
(v) developing modeling tools to im-
prove event consequence assessment and de-
cision support; and 
(vi) preparing risk communication 
tools and enhancing public awareness 
through outreach. 
(B) 
DETECTION
GOAL.—Improve 
agri-
culture and food system detection capabilities 
by— 
(i) identifying contamination in food 
products at the earliest possible time; and 
(ii) conducting surveillance to prevent 
the spread of diseases.
252 
(C) EMERGENCY RESPONSE GOAL.—Ensure 
an efficient response to agriculture and food 
emergencies by— 
(i) immediately investigating animal 
disease outbreaks and suspected food con-
tamination; 
(ii) preventing additional human ill-
nesses; 
(iii) organizing, training, and equip-
ping animal, plant, and food emergency re-
sponse teams of— 
(I) the Federal Government; and 
(II) State, local, and tribal gov-
ernments; 
(iv) designing, developing, and evalu-
ating training and exercises carried out 
under agriculture and food defense plans; 
and 
(v) ensuring consistent and organized 
risk communication to the public by— 
(I) the Federal Government; 
(II) State, local, and tribal gov-
ernments; and 
(III) the private sector.
253 
(D) RECOVERY
GOAL.—Secure agriculture 
and food production after an agriculture or food 
emergency by— 
(i) working with the private sector to 
develop business recovery plans to rapidly 
resume agriculture, food production, and 
international trade; 
(ii) conducting exercises of the plans 
described in subparagraph (C) with the goal 
of long-term recovery results; 
(iii) rapidly removing, and effectively 
disposing of— 
(I) contaminated agriculture and 
food products; and 
(II) infected plants and animals; 
and 
(iv) decontaminating and restoring 
areas affected by an agriculture or food 
emergency. 
(3) EVALUATION.—The Secretary, in coordina-
tion with the Secretary of Agriculture and the Sec-
retary of Homeland Security, shall— 
(A) develop metrics to measure progress for 
the evaluation process described in paragraph 
(1)(B); and
254 
(B) report on the progress measured in sub-
paragraph (A) as part of the National Agri-
culture and Food Defense strategy described in 
subsection (a)(1). 
(c) LIMITED DISTRIBUTION.—In the interest of na-
tional security, the Secretary of Health and Human Serv-
ices and the Secretary of Agriculture, in coordination with 
the Secretary of Homeland Security, may determine the 
manner and format in which the National Agriculture and 
Food Defense strategy established under this section is made 
publicly available on the Internet Web sites of the Depart-
ment of Health and Human Services, the Department of 
Homeland Security, and the Department of Agriculture, as 
described in subsection (a)(1). 
SEC. 6109. FOOD AND AGRICULTURE COORDINATING COUN-
CILS. 
The Secretary of Homeland Security, in coordination 
with the Secretary of Health and Human Services and the 
Secretary of Agriculture, shall within 180 days of enact-
ment of this Act, and annually thereafter, submit to the 
relevant committees of Congress, and make publicly avail-
able on the Internet Web site of the Department of Home-
land Security, a report on the activities of the Food and 
Agriculture Government Coordinating Council and the
255 
Food and Agriculture Sector Coordinating Council, includ-
ing the progress of such Councils on— 
(1) facilitating partnerships between public and 
private entities to help coordinate and enhance the 
protection of the agriculture and food system of the 
United States; 
(2) providing for the regular and timely inter-
change of information between each council relating 
to the security of the agriculture and food system (in-
cluding intelligence information); 
(3) identifying best practices and methods for 
improving the coordination among Federal, State, 
local, and private sector preparedness and response 
plans for agriculture and food defense; and 
(4) recommending methods by which to protect 
the economy and the public health of the United 
States from the effects of— 
(A) animal or plant disease outbreaks; 
(B) food contamination; and 
(C) natural disasters affecting agriculture 
and food. 
SEC. 6110. BUILDING DOMESTIC CAPACITY. 
(a) IN GENERAL.— 
(1) INITIAL REPORT.—The Secretary, in coordi-
nation with the Secretary of Agriculture and the Sec-
256 
retary of Homeland Security, shall, not later than 2 
years after the date of enactment of this Act, submit 
to Congress a comprehensive report that identifies 
programs and practices that are intended to promote 
the safety and supply chain security of food and to 
prevent outbreaks of foodborne illness and other food- 
related hazards that can be addressed through preven-
tive activities. Such report shall include a description 
of the following: 
(A) Analysis of the need for further regula-
tions or guidance to industry. 
(B) Outreach to food industry sectors, in-
cluding through the Food and Agriculture Co-
ordinating Councils referred to in section 6109, 
to identify potential sources of emerging threats 
to the safety and security of the food supply and 
preventive strategies to address those threats. 
(C) Systems to ensure the prompt distribu-
tion to the food industry of information and 
technical assistance concerning preventive strate-
gies. 
(D) Communication systems to ensure that 
information about specific threats to the safety 
and security of the food supply are rapidly and 
effectively disseminated.
257 
(E) Surveillance systems and laboratory 
networks to rapidly detect and respond to 
foodborne illness outbreaks and other food-related 
hazards, including how such systems and net-
works are integrated. 
(F) Outreach, education, and training pro-
vided to States and local governments to build 
State and local food safety and food defense ca-
pabilities, 
including 
progress 
implementing 
strategies developed under sections 6108 and 
6205. 
(G) The estimated resources needed to effec-
tively implement the programs and practices 
identified in the report developed in this section 
over a 5-year period. 
(H) The impact of requirements under this 
Act (including amendments made by this Act) 
on certified organic farms and facilities (as de-
fined in section 415 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 350d)). 
(I) Specific efforts taken pursuant to the 
agreements authorized under section 421(c) of 
the Federal Food, Drug, and Cosmetic Act (as 
added by section 6201), together with, as nec-
258 
essary, a description of any additional authori-
ties necessary to improve seafood safety. 
(2) BIENNIAL REPORTS.—On a biennial basis 
following the submission of the report under para-
graph (1), the Secretary shall submit to Congress a 
report that— 
(A) reviews previous food safety programs 
and practices; 
(B) outlines the success of those programs 
and practices; 
(C) identifies future programs and prac-
tices; and 
(D) includes information related to any 
matter described in subparagraphs (A) through 
(H) of paragraph (1), as necessary. 
(b) RISK-BASED ACTIVITIES.—The report developed 
under subsection (a)(1) shall describe methods that seek to 
ensure that resources available to the Secretary for food 
safety-related activities are directed at those actions most 
likely to reduce risks from food, including the use of preven-
tive strategies and allocation of inspection resources. The 
Secretary shall promptly undertake those risk-based actions 
that are identified during the development of the report as 
likely to contribute to the safety and security of the food 
supply.
259 
(c) CAPABILITY
FOR LABORATORY ANALYSES; RE-
SEARCH.—The report developed under subsection (a)(1) 
shall provide a description of methods to increase capacity 
to undertake analyses of food samples promptly after collec-
tion, to identify new and rapid analytical techniques, in-
cluding commercially available techniques that can be em-
ployed at ports of entry and by Food Emergency Response 
Network laboratories, and to provide for well-equipped and 
staffed laboratory facilities and progress toward laboratory 
accreditation under section 422 of the Federal Food, Drug, 
and Cosmetic Act (as added by section 6202). 
(d) INFORMATION TECHNOLOGY.—The report devel-
oped under subsection (a)(1) shall include a description of 
such information technology systems as may be needed to 
identify risks and receive data from multiple sources, in-
cluding foreign governments, State, local, and tribal govern-
ments, other Federal agencies, the food industry, labora-
tories, laboratory networks, and consumers. The informa-
tion technology systems that the Secretary describes shall 
also provide for the integration of the facility registration 
system under section 415 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 350d), and the prior notice system 
under section 801(m) of such Act (21 U.S.C. 381(m)) with 
other information technology systems that are used by the
260 
Federal Government for the processing of food offered for 
import into the United States. 
(e) AUTOMATED RISK ASSESSMENT.—The report de-
veloped under subsection (a)(1) shall include a description 
of progress toward developing and improving an automated 
risk assessment system for food safety surveillance and allo-
cation of resources. 
(f) TRACEBACK
AND SURVEILLANCE REPORT.—The 
Secretary shall include in the report developed under sub-
section (a)(1) an analysis of the Food and Drug Adminis-
tration’s performance in foodborne illness outbreaks during 
the 5-year period preceding the date of enactment of this 
Act involving fruits and vegetables that are raw agricul-
tural commodities (as defined in section 6201(r) (21 U.S.C. 
321(r)) and recommendations for enhanced surveillance, 
outbreak response, and traceability. Such findings and rec-
ommendations shall address communication and coordina-
tion with the public, industry, and State and local govern-
ments, as such communication and coordination relates to 
outbreak identification and traceback. 
(g) BIENNIAL FOOD SAFETY AND FOOD DEFENSE RE-
SEARCH PLAN.—The Secretary, the Secretary of Agri-
culture, and the Secretary of Homeland Security shall, on 
a biennial basis, submit to Congress a joint food safety and 
food defense research plan which may include studying the
261 
long-term health effects of foodborne illness. Such biennial 
plan shall include a list and description of projects con-
ducted during the previous 2-year period and the plan for 
projects to be conducted during the subsequent 2-year pe-
riod. 
(h) EFFECTIVENESS OF PROGRAMS ADMINISTERED BY 
THE DEPARTMENT OF HEALTH AND HUMAN SERVICES.— 
(1) IN GENERAL.—To determine whether existing 
Federal programs administered by the Department of 
Health and Human Services are effective in achieving 
the stated goals of such programs, the Secretary shall, 
beginning not later than 1 year after the date of en-
actment of this Act— 
(A) conduct an annual evaluation of each 
program of such Department to determine the ef-
fectiveness of each such program in achieving 
legislated intent, purposes, and objectives; and 
(B) submit to Congress a report concerning 
such evaluation. 
(2) CONTENT.—The report described under para-
graph (1)(B) shall— 
(A) include conclusions concerning the rea-
sons that such existing programs have proven 
successful or not successful and what factors con-
tributed to such conclusions;
262 
(B) include recommendations for consolida-
tion and elimination to reduce duplication and 
inefficiencies in such programs at such Depart-
ment as identified during the evaluation conduct 
under this subsection; and 
(C) be made publicly available in a publi-
cation entitled ‘‘Guide to the U.S. Department of 
Health and Human Services Programs’’. 
(i) UNIQUE IDENTIFICATION NUMBERS.— 
(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of this Act, the Secretary, act-
ing through the Commissioner of Food and Drugs, 
shall conduct a study regarding the need for, and 
challenges associated with, development and imple-
mentation of a program that requires a unique iden-
tification number for each food facility registered 
with the Secretary and, as appropriate, each broker 
that imports food into the United States. Such study 
shall include an evaluation of the costs associated 
with development and implementation of such a sys-
tem, and make recommendations about what new au-
thorities, if any, would be necessary to develop and 
implement such a system. 
(2) REPORT.—Not later than 15 months after the 
date of enactment of this Act, the Secretary shall sub-
263 
mit to Congress a report that describes the findings 
of the study conducted under paragraph (1) and that 
includes any recommendations determined appro-
priate by the Secretary. 
SEC. 6111. SANITARY TRANSPORTATION OF FOOD. 
(a) IN GENERAL.—Not later than 18 months after the 
date of enactment of this Act, the Secretary shall promul-
gate regulations described in section 416(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 350e(b)). 
(b) FOOD TRANSPORTATION STUDY.—The Secretary, 
acting through the Commissioner of Food and Drugs, shall 
conduct a study of the transportation of food for consump-
tion in the United States, including transportation by air, 
that includes an examination of the unique needs of rural 
and frontier areas with regard to the delivery of safe food. 
SEC. 6112. FOOD ALLERGY AND ANAPHYLAXIS MANAGE-
MENT. 
(a) DEFINITIONS.—In this section: 
(1) EARLY CHILDHOOD EDUCATION PROGRAM.— 
The term ‘‘early childhood education program’’ 
means— 
(A) a Head Start program or an Early 
Head Start program carried out under the Head 
Start Act (42 U.S.C. 9831 et seq.);
264 
(B) a State licensed or regulated child care 
program or school; or 
(C) a State prekindergarten program that 
serves children from birth through kindergarten. 
(2) ESEA DEFINITIONS.—The terms ‘‘local edu-
cational agency’’, ‘‘secondary school’’, ‘‘elementary 
school’’, and ‘‘parent’’ have the meanings given the 
terms in section 9101 of the Elementary and Sec-
ondary Education Act of 1965 (20 U.S.C. 7801). 
(3) SCHOOL.—The term ‘‘school’’ includes pub-
lic— 
(A) kindergartens; 
(B) elementary schools; and 
(C) secondary schools. 
(4) SECRETARY.—The term ‘‘Secretary’’ means 
the Secretary of Health and Human Services. 
(b) ESTABLISHMENT OF VOLUNTARY FOOD ALLERGY 
AND ANAPHYLAXIS MANAGEMENT GUIDELINES.— 
(1) ESTABLISHMENT.— 
(A) IN GENERAL.—Not later than 1 year 
after the date of enactment of this Act, the Sec-
retary, in consultation with the Secretary of 
Education, shall— 
(i) develop guidelines to be used on a 
voluntary basis to develop plans for indi-
265 
viduals to manage the risk of food allergy 
and anaphylaxis in schools and early child-
hood education programs; and 
(ii) make such guidelines available to 
local educational agencies, schools, early 
childhood education programs, and other 
interested entities and individuals to be im-
plemented on a voluntary basis only. 
(B) APPLICABILITY OF FERPA.—Each plan 
described in subparagraph (A) that is developed 
for an individual shall be considered an edu-
cation record for the purpose of section 444 of the 
General Education Provisions Act (commonly re-
ferred to as the ‘‘Family Educational Rights and 
Privacy Act of 1974’’) (20 U.S.C. 1232g). 
(2) CONTENTS.—The voluntary guidelines devel-
oped by the Secretary under paragraph (1) shall ad-
dress each of the following and may be updated as the 
Secretary determines necessary: 
(A) Parental obligation to provide the 
school or early childhood education program, 
prior to the start of every school year, with— 
(i) documentation from their child’s 
physician or nurse—
266 
(I) supporting a diagnosis of food 
allergy, and any risk of anaphylaxis, if 
applicable; 
(II) identifying any food to which 
the child is allergic; 
(III) describing, if appropriate, 
any prior history of anaphylaxis; 
(IV) listing any medication pre-
scribed for the child for the treatment 
of anaphylaxis; 
(V) detailing emergency treatment 
procedures in the event of a reaction; 
(VI) listing the signs and symp-
toms of a reaction; and 
(VII) assessing the child’s readi-
ness for self-administration of prescrip-
tion medication; and 
(ii) a list of substitute meals that may 
be offered to the child by school or early 
childhood education program food service 
personnel. 
(B) The creation and maintenance of an in-
dividual plan for food allergy management, in 
consultation with the parent, tailored to the 
needs of each child with a documented risk for
268 
(G) The authorization and training of 
school or early childhood education program per-
sonnel to administer epinephrine when the nurse 
is not immediately available. 
(H) The timely accessibility of epinephrine 
by school or early childhood education program 
personnel when the nurse is not immediately 
available. 
(I) The creation of a plan contained in each 
individual plan for food allergy management 
that addresses the appropriate response to an in-
cident of anaphylaxis of a child while such child 
is engaged in extracurricular programs of a 
school or early childhood education program, 
such as nonacademic outings and field trips, 
before- and after-school programs or before- and 
after-early child education program programs, 
and school-sponsored or early childhood edu-
cation program-sponsored programs held on 
weekends. 
(J) Maintenance of information for each 
administration of epinephrine to a child at risk 
for anaphylaxis and prompt notification to par-
ents.
269 
(K) Other elements the Secretary determines 
necessary for the management of food allergies 
and anaphylaxis in schools and early childhood 
education programs. 
(3) RELATION TO STATE LAW.—Nothing in this 
section or the guidelines developed by the Secretary 
under paragraph (1) shall be construed to preempt 
State law, including any State law regarding whether 
students at risk for anaphylaxis may self-administer 
medication. 
(c) SCHOOL-BASED FOOD ALLERGY MANAGEMENT 
GRANTS.— 
(1) IN
GENERAL.—The Secretary may award 
grants to local educational agencies to assist such 
agencies with implementing voluntary food allergy 
and anaphylaxis management guidelines described in 
subsection (b). 
(2) APPLICATION.— 
(A) IN GENERAL.—To be eligible to receive 
a grant under this subsection, a local edu-
cational agency shall submit an application to 
the Secretary at such time, in such manner, and 
including such information as the Secretary may 
reasonably require.
270 
(B) CONTENTS.—Each application sub-
mitted under subparagraph (A) shall include— 
(i) an assurance that the local edu-
cational agency has developed plans in ac-
cordance with the food allergy and anaphy-
laxis management guidelines described in 
subsection (b); 
(ii) a description of the activities to be 
funded by the grant in carrying out the 
food allergy and anaphylaxis management 
guidelines, including— 
(I) how the guidelines will be car-
ried out at individual schools served by 
the local educational agency; 
(II) how the local educational 
agency will inform parents and stu-
dents of the guidelines in place; 
(III) how school nurses, teachers, 
administrators, and other school-based 
staff will be made aware of, and given 
training on, when applicable, the 
guidelines in place; and 
(IV) any other activities that the 
Secretary determines appropriate;
271 
(iii) an itemization of how grant funds 
received under this subsection will be ex-
pended; 
(iv) a description of how adoption of 
the guidelines and implementation of grant 
activities will be monitored; and 
(v) an agreement by the local edu-
cational agency to report information re-
quired by the Secretary to conduct evalua-
tions under this subsection. 
(3) USE
OF
FUNDS.—Each local educational 
agency that receives a grant under this subsection 
may use the grant funds for the following: 
(A) Purchase of materials and supplies, in-
cluding limited medical supplies such as epi-
nephrine and disposable wet wipes, to support 
carrying out the food allergy and anaphylaxis 
management guidelines described in subsection 
(b). 
(B) In partnership with local health depart-
ments, school nurse, teacher, and personnel 
training for food allergy management. 
(C) Programs that educate students as to 
the presence of, and policies and procedures in
272 
place related to, food allergies and anaphylactic 
shock. 
(D) Outreach to parents. 
(E) Any other activities consistent with the 
guidelines described in subsection (b). 
(4) DURATION OF AWARDS.—The Secretary may 
award grants under this subsection for a period of not 
more than 2 years. In the event the Secretary con-
ducts a program evaluation under this subsection, 
funding in the second year of the grant, where appli-
cable, shall be contingent on a successful program 
evaluation by the Secretary after the first year. 
(5) LIMITATION ON GRANT FUNDING.—The Sec-
retary may not provide grant funding to a local edu-
cational agency under this subsection after such local 
educational agency has received 2 years of grant 
funding under this subsection. 
(6) MAXIMUM AMOUNT OF ANNUAL AWARDS.—A 
grant awarded under this subsection may not be 
made in an amount that is more than $50,000 annu-
ally. 
(7) PRIORITY.—In awarding grants under this 
subsection, the Secretary shall give priority to local 
educational agencies with the highest percentages of 
children who are counted under section 1124(c) of the
273 
Elementary and Secondary Education Act of 1965 
(20 U.S.C. 6333(c)). 
(8) MATCHING FUNDS.— 
(A) IN GENERAL.—The Secretary may not 
award a grant under this subsection unless the 
local educational agency agrees that, with respect 
to the costs to be incurred by such local edu-
cational agency in carrying out the grant activi-
ties, the local educational agency shall make 
available (directly or through donations from 
public or private entities) non-Federal funds to-
ward such costs in an amount equal to not less 
than 25 percent of the amount of the grant. 
(B) DETERMINATION OF AMOUNT OF NON- 
FEDERAL
CONTRIBUTION.—Non-Federal funds 
required under subparagraph (A) may be cash or 
in kind, including plant, equipment, or services. 
Amounts provided by the Federal Government, 
and any portion of any service subsidized by the 
Federal Government, may not be included in de-
termining the amount of such non-Federal funds. 
(9) ADMINISTRATIVE
FUNDS.—A local edu-
cational agency that receives a grant under this sub-
section may use not more than 2 percent of the grant
274 
amount for administrative costs related to carrying 
out this subsection. 
(10) PROGRESS AND EVALUATIONS.—At the com-
pletion of the grant period referred to in paragraph 
(4), a local educational agency shall provide the Sec-
retary with information on how grant funds were 
spent and the status of implementation of the food al-
lergy and anaphylaxis management guidelines de-
scribed in subsection (b). 
(11) 
SUPPLEMENT, 
NOT
SUPPLANT.—Grant 
funds received under this subsection shall be used to 
supplement, and not supplant, non-Federal funds and 
any other Federal funds available to carry out the ac-
tivities described in this subsection. 
(12) AUTHORIZATION
OF
APPROPRIATIONS.— 
There is authorized to be appropriated to carry out 
this subsection $30,000,000 for fiscal year 2011 and 
such sums as may be necessary for each of the 4 suc-
ceeding fiscal years. 
(d) VOLUNTARY NATURE OF GUIDELINES.— 
(1) IN GENERAL.—The food allergy and anaphy-
laxis management guidelines developed by the Sec-
retary under subsection (b) are voluntary. Nothing in 
this section or the guidelines developed by the Sec-
retary under subsection (b) shall be construed to re-
275 
quire a local educational agency to implement such 
guidelines. 
(2) EXCEPTION.—Notwithstanding paragraph 
(1), the Secretary may enforce an agreement by a 
local educational agency to implement food allergy 
and anaphylaxis management guidelines as a condi-
tion of the receipt of a grant under subsection (c). 
SEC. 6113. NEW DIETARY INGREDIENTS. 
(a) IN GENERAL.—Section 413 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 350b) is amended— 
(1) by redesignating subsection (c) as subsection 
(d); and 
(2) by inserting after subsection (b) the fol-
lowing: 
‘‘(c) NOTIFICATION.— 
‘‘(1) IN GENERAL.—If the Secretary determines 
that the information in a new dietary ingredient no-
tification submitted under this section for an article 
purported to be a new dietary ingredient is inad-
equate to establish that a dietary supplement con-
taining such article will reasonably be expected to be 
safe because the article may be, or may contain, an 
anabolic steroid or an analogue of an anabolic ster-
oid, the Secretary shall notify the Drug Enforcement 
Administration of such determination. Such notifica-
276 
tion by the Secretary shall include, at a minimum, 
the name of the dietary supplement or article, the 
name of the person or persons who marketed the prod-
uct or made the submission of information regarding 
the article to the Secretary under this section, and 
any contact information for such person or persons 
that the Secretary has. 
‘‘(2) DEFINITIONS.—For purposes of this sub-
section— 
‘‘(A) the term ‘anabolic steroid’ has the 
meaning given such term in section 102(41) of 
the Controlled Substances Act; and 
‘‘(B) the term ‘analogue of an anabolic ster-
oid’ means a substance whose chemical structure 
is substantially similar to the chemical structure 
of an anabolic steroid.’’. 
(b) GUIDANCE.—Not later than 180 days after the date 
of enactment of this Act, the Secretary shall publish guid-
ance that clarifies when a dietary supplement ingredient 
is a new dietary ingredient, when the manufacturer or dis-
tributor of a dietary ingredient or dietary supplement 
should provide the Secretary with information as described 
in section 413(a)(2) of the Federal Food, Drug, and Cos-
metic Act, the evidence needed to document the safety of new
277 
dietary ingredients, and appropriate methods for estab-
lishing the identify of a new dietary ingredient. 
SEC. 6114. REQUIREMENT FOR GUIDANCE RELATING TO 
POST-HARVEST PROCESSING OF RAW OYS-
TERS. 
(a) IN GENERAL.—Not later than 90 days prior to the 
issuance of any guidance, regulation, or suggested amend-
ment by the Food and Drug Administration to the National 
Shellfish Sanitation Program’s Model Ordinance, or the 
issuance of any guidance or regulation by the Food and 
Drug Administration relating to the Seafood Hazard Anal-
ysis Critical Control Points Program of the Food and Drug 
Administration (parts 123 and 1240 of title 21, Code of 
Federal Regulations (or any successor regulations), where 
such guidance, regulation, or suggested amendment relates 
to post-harvest processing for raw oysters, the Secretary 
shall prepare and submit to the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of Represent-
atives a report which shall include— 
(1) an assessment of how post-harvest processing 
or other equivalent controls feasibly may be imple-
mented in the fastest, safest, and most economical 
manner;
278 
(2) the projected public health benefits of any 
proposed post-harvest processing; 
(3) the projected costs of compliance with such 
post-harvest processing measures; 
(4) the impact post-harvest processing is expected 
to have on the sales, cost, and availability of raw oys-
ters; 
(5) criteria for ensuring post-harvest processing 
standards will be applied equally to shellfish imported 
from all nations of origin; 
(6) an evaluation of alternative measures to pre-
vent, eliminate, or reduce to an acceptable level the 
occurrence of foodborne illness; and 
(7) the extent to which the Food and Drug Ad-
ministration has consulted with the States and other 
regulatory agencies, as appropriate, with regard to 
post-harvest processing measures. 
(b) LIMITATION.—Subsection (a) shall not apply to the 
guidance described in section 6103(h). 
(c) REVIEW AND EVALUATION.—Not later than 30 
days after the Secretary issues a proposed regulation or 
guidance described in subsection (a), the Comptroller Gen-
eral of the United States shall—
279 
(1) review and evaluate the report described in 
subsection (a) and report to Congress on the findings 
of the estimates and analysis in the report; 
(2) compare such proposed regulation or guid-
ance to similar regulations or guidance with respect 
to other regulated foods, including a comparison of 
risks the Secretary may find associated with seafood 
and the instances of those risks in such other regu-
lated foods; and 
(3) evaluate the impact of post-harvest processing 
on the competitiveness of the domestic oyster industry 
in the United States and in international markets. 
(d) WAIVER.—The requirement of preparing a report 
under subsection (a) shall be waived if the Secretary issues 
a guidance that is adopted as a consensus agreement be-
tween Federal and State regulators and the oyster industry, 
acting through the Interstate Shellfish Sanitation Con-
ference. 
(e) PUBLIC ACCESS.—Any report prepared under this 
section shall be made available to the public. 
SEC. 6115. PORT SHOPPING. 
Until the date on which the Secretary promulgates a 
final rule that implements the amendments made by section 
308 of the Public Health Security and Bioterrorism Pre-
paredness and Response Act of 2002 (Public Law 107–188),
280 
the Secretary shall notify the Secretary of Homeland Secu-
rity of all instances in which the Secretary refuses to admit 
a food into the United States under section 801(a) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) 
so that the Secretary of Homeland Security, acting through 
the Commissioner of Customs and Border Protection, may 
prevent food refused admittance into the United States by 
a United States port of entry from being admitted by an-
other United States port of entry, through the notification 
of other such United States ports of entry. 
SEC. 6116. ALCOHOL-RELATED FACILITIES. 
(a) IN GENERAL.—Except as provided by sections 
6102, 6206, 6207, 6302, 6304, 6402, 6403, and 6404 of this 
Act, and the amendments made by such sections, nothing 
in this Act, or the amendments made by this Act, shall be 
construed to apply to a facility that— 
(1) under the Federal Alcohol Administration 
Act (27 U.S.C. 201 et seq.) or chapter 51 of subtitle 
E of the Internal Revenue Code of 1986 (26 U.S.C. 
5001 et seq.) is required to obtain a permit or to reg-
ister with the Secretary of the Treasury as a condi-
tion of doing business in the United States; and 
(2) under section 415 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 350d) is required to reg-
ister as a facility because such facility is engaged in
281 
manufacturing, processing, packing, or holding 1 or 
more alcoholic beverages, with respect to the activities 
of such facility that relate to the manufacturing, 
processing, packing, or holding of alcoholic beverages. 
(b) LIMITED RECEIPT AND DISTRIBUTION OF NON-
ALCOHOL FOOD.—Subsection (a) shall not apply to a facil-
ity engaged in the receipt and distribution of any non-
alcohol food, except that such paragraph shall apply to a 
facility described in such paragraph that receives and dis-
tributes nonalcohol food, provided such food is received and 
distributed— 
(1) in a prepackaged form that prevents any di-
rect human contact with such food; and 
(2) in amounts that constitute not more than 5 
percent of the overall sales of such facility, as deter-
mined by the Secretary of the Treasury. 
(c) RULE OF CONSTRUCTION.—Except as provided in 
subsections (a) and (b), this section shall not be construed 
to exempt any food, other than alcoholic beverages, as de-
fined in section 214 of the Federal Alcohol Administration 
Act (27 U.S.C. 214), from the requirements of this Act (in-
cluding the amendments made by this Act).
282 
TITLE II—IMPROVING CAPACITY 
TO DETECT AND RESPOND TO 
FOOD SAFETY PROBLEMS 
SEC. 6201. TARGETING OF INSPECTION RESOURCES FOR 
DOMESTIC FACILITIES, FOREIGN FACILITIES, 
AND PORTS OF ENTRY; ANNUAL REPORT. 
(a) TARGETING OF INSPECTION RESOURCES FOR DO-
MESTIC FACILITIES, FOREIGN FACILITIES, AND PORTS OF 
ENTRY.—Chapter IV (21 U.S.C. 341 et seq.), as amended 
by section 6106, is amended by adding at the end the fol-
lowing: 
‘‘SEC. 421. TARGETING OF INSPECTION RESOURCES FOR 
DOMESTIC FACILITIES, FOREIGN FACILITIES, 
AND PORTS OF ENTRY; ANNUAL REPORT. 
‘‘(a) IDENTIFICATION
AND INSPECTION
OF FACILI-
TIES.— 
‘‘(1) IDENTIFICATION.—The Secretary shall iden-
tify 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.
283 
‘‘(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 fa-
cility’s hazard analysis and risk-based preven-
tive controls. 
‘‘(D) Whether the food manufactured, proc-
essed, packed, or held at the facility meets the 
criteria for priority under section 801(h)(1). 
‘‘(E) Whether the food or the facility that 
manufactured, 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 appropriate 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 Moderniza-
tion Act, the Secretary shall increase the fre-
quency of inspection of all facilities. 
‘‘(B) DOMESTIC
HIGH-RISK
FACILITIES.— 
The Secretary shall increase the frequency of in-
spection of domestic facilities identified under
284 
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 thereafter. 
‘‘(C) DOMESTIC
NON-HIGH-RISK
FACILI-
TIES.—The Secretary shall ensure that each do-
mestic facility that is not identified under para-
graph (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 thereafter. 
‘‘(D) FOREIGN FACILITIES.— 
‘‘(i) YEAR 1.—In the 1-year period fol-
lowing the date of enactment of the FDA 
Food Safety Modernization Act, the Sec-
retary shall inspect not fewer than 600 for-
eign facilities.
285 
‘‘(ii) SUBSEQUENT YEARS.—In each of 
the 5 years following the 1-year period de-
scribed in clause (i), the Secretary shall in-
spect not fewer than twice the number of 
foreign facilities inspected by the Secretary 
during the previous year. 
‘‘(E) RELIANCE
ON
FEDERAL, STATE, OR 
LOCAL INSPECTIONS.—In meeting the inspection 
requirements under this subsection for domestic 
facilities, the Secretary may rely on inspections 
conducted by other Federal, State, or local agen-
cies under interagency agreements, contracts, 
memoranda of understanding, or other obliga-
tions. 
‘‘(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 accord-
ing 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.
286 
‘‘(3) The compliance history of the importer, in-
cluding with regard to food recalls, outbreaks of 
foodborne illness, and violations of food safety stand-
ards. 
‘‘(4) The rigor and effectiveness of the activities 
conducted by the importer of such article of food to 
satisfy the requirements of the foreign supplier 
verification program under section 805. 
‘‘(5) Whether the food importer participates in 
the voluntary qualified importer program under sec-
tion 806. 
‘‘(6) Whether the food meets the criteria for pri-
ority under section 801(h)(1). 
‘‘(7) Whether the food or the facility that manu-
factured, 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 allo-
cating inspection resources. 
‘‘(c) INTERAGENCY AGREEMENTS WITH RESPECT TO 
SEAFOOD.— 
‘‘(1) IN GENERAL.—The Secretary of Health and 
Human Services, the Secretary of Commerce, the Sec-
retary of Homeland Security, the Chairman of the 
Federal Trade Commission, and the heads of other
287 
appropriate agencies may enter into such agreements 
as may be necessary or appropriate to improve sea-
food safety. 
‘‘(2) SCOPE OF AGREEMENTS.—The agreements 
under paragraph (1) may include— 
‘‘(A) cooperative arrangements for exam-
ining 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, inspection 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 modi-
fication of existing processes, by which officers 
and employees of the National Oceanic and At-
mospheric Administration may be duly des-
ignated by the Secretary to carry out seafood ex-
aminations and investigations under section 801 
of this Act or section 203 of the Food Allergen 
Labeling and Consumer Protection Act of 2004;
288 
‘‘(F) the sharing of information concerning 
observed noncompliance 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 ef-
fectiveness by Federal authorities; and 
‘‘(H) outreach on Federal efforts to enhance 
seafood safety and compliance with Federal food 
safety requirements. 
‘‘(d) COORDINATION.—The Secretary shall improve co-
ordination and cooperation with the Secretary of Agri-
culture 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 February 1 of each year, the Secretary shall submit 
to Congress a report, including efforts to coordinate and
289 
cooperate with other Federal agencies with responsibilities 
for food inspections, regarding— 
‘‘(1) information about food facilities includ-
ing— 
‘‘(A) the appropriations used to inspect fa-
cilities registered 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 pursu-
ant 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 pursu-
ant to section 415 that were scheduled for inspec-
tion in the previous fiscal year and which the 
Secretary did not inspect in such year; 
‘‘(E) the number of high-risk facilities iden-
tified pursuant to section 421 that the Secretary 
inspected in the previous fiscal year; and 
‘‘(F) the number of high-risk facilities iden-
tified pursuant to section 421 that were sched-
290 
uled 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 phys-
ically 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 fis-
cal year; and 
‘‘(C) the average cost of physically inspect-
ing or sampling 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 estab-
lished; and 
‘‘(B) the number of personnel permanently 
stationed in each foreign office. 
‘‘(i) PUBLIC AVAILABILITY
OF ANNUAL FOOD RE-
PORTS.—The Secretary shall make the reports required
291 
under subsection (h) available to the public on the Internet 
Web site of the Food and Drug Administration.’’. 
(c) ADVISORY COMMITTEE CONSULTATION.—In allo-
cating inspection 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 Depart-
ment of Health and Human Services. 
SEC. 6202. LABORATORY ACCREDITATION FOR ANALYSES 
OF FOODS. 
(a) IN GENERAL.—Chapter IV (21 U.S.C. 341 et seq.), 
as amended by section 6201, is amended by adding at the 
end the following: 
‘‘SEC. 422. LABORATORY ACCREDITATION FOR ANALYSES 
OF FOODS. 
‘‘(a) RECOGNITION
OF
LABORATORY
ACCREDITA-
TION.— 
‘‘(1) IN GENERAL.—Not later than 2 years after 
the date of enactment of the FDA Food Safety Mod-
ernization Act, the Secretary shall— 
‘‘(A) establish a program for the testing of 
food by accredited laboratories; 
‘‘(B) establish a publicly available registry 
of accreditation bodies recognized by the Sec-
retary and laboratories accredited by a recog-
292 
nized 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 accreditation, as appropriate, that recognized 
accreditation bodies and accredited laboratories 
report to the Secretary any changes that would 
affect the recognition of such accreditation 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 accredi-
tation of laboratories, including independent private 
laboratories and laboratories run and operated by a 
Federal agency (including the Department of Com-
merce), State, or locality with a demonstrated capa-
bility to conduct 1 or more sampling and analytical 
testing methodologies for food. 
‘‘(3) INCREASING THE NUMBER OF QUALIFIED 
LABORATORIES.—The Secretary shall work with the 
laboratory accreditation bodies recognized under 
paragraph (1), as appropriate, to increase the num-
ber of qualified laboratories that are eligible to per-
293 
form testing under subsection (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 es-
tablished under paragraph (1)(B) is made publicly 
available. 
‘‘(5) FOREIGN
LABORATORIES.—Accreditation 
bodies recognized by the Secretary under paragraph 
(1) may accredit laboratories that operate outside the 
United States, so long as such laboratories meet the 
accreditation standards applicable to domestic labora-
tories accredited under this section. 
‘‘(6) MODEL
LABORATORY
STANDARDS.—The 
Secretary shall develop model standards that a lab-
oratory shall meet to be accredited by a recognized ac-
creditation body for a specified sampling or analyt-
ical testing methodology and included in the registry 
provided for under paragraph (1). In developing the 
model standards, the Secretary shall consult existing 
standards for guidance. The model standards shall in-
clude— 
‘‘(A) methods to ensure that—
294 
‘‘(i) appropriate sampling, analytical 
procedures (including rapid analytical pro-
cedures), and commercially available tech-
niques are followed and reports of analyses 
are certified as true and accurate; 
‘‘(ii) internal quality systems are es-
tablished 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 sam-
pling and analyses are qualified by train-
ing and experience to do so; and 
‘‘(B) any other criteria determined appro-
priate by the Secretary. 
‘‘(7) REVIEW OF RECOGNITION.—To ensure com-
pliance with the requirements of this section, the Sec-
retary— 
‘‘(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
295 
‘‘(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 condi-
tions necessary for laboratories accredited by 
such body to continue to perform testing as de-
scribed 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-Federal laboratories that 
have been accredited for the appropriate sampling or 
analytical testing methodology or methodologies by a 
recognized accreditation body on the registry estab-
lished by the Secretary under subsection (a)(1)(B) 
whenever such testing is conducted— 
‘‘(A) by or on behalf of an owner or con-
signee— 
‘‘(i) in response to a specific testing re-
quirement under this Act or implementing 
regulations, when applied to address an 
identified or suspected food safety problem; 
and
296 
‘‘(ii) as required by the Secretary, as 
the Secretary deems appropriate, to address 
an identified or suspected food safety prob-
lem; or 
‘‘(B) on behalf of an owner or consignee— 
‘‘(i) in support of admission of an ar-
ticle of food under section 801(a); and 
‘‘(ii) under an Import Alert that re-
quires 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 re-
sults 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 re-
quirements under this subsection if— 
‘‘(A) a new methodology or methodologies 
have been developed and validated but a labora-
tory has not yet been accredited to perform such 
methodology or methodologies; and
297 
‘‘(B) the use of such methodology or meth-
odologies are necessary to prevent, control, or 
mitigate a food emergency or foodborne illness 
outbreak. 
‘‘(c) REVIEW BY SECRETARY.—If food sampling and 
testing performed by a laboratory run and operated by a 
State or locality that is accredited by a recognized accredi-
tation 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 results for 
the purpose of determining the need for a national recall 
or other compliance and enforcement activities. 
‘‘(d) NO LIMIT ON SECRETARIAL AUTHORITY.—Noth-
ing 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 Agri-
culture, 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 there-
after, submit to the relevant committees of Congress, and 
make publicly available on the Internet Web site of the De-
partment of Health and Human Services, a report on the
298 
progress in implementing a national food emergency re-
sponse laboratory network that— 
(1) provides ongoing surveillance, rapid detec-
tion, 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 among 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 reposi-
tory for use by Federal, State, and local officials; 
(5) responds to food-related emergencies; and 
(6) is integrated with relevant laboratory net-
works administered by other Federal agencies. 
SEC. 6203. INTEGRATED CONSORTIUM OF LABORATORY 
NETWORKS. 
(a) IN GENERAL.—The Secretary of Homeland Secu-
rity, in coordination with the Secretary of Health and 
Human Services, the Secretary of Agriculture, the Secretary
299 
of Commerce, and the Administrator of the Environmental 
Protection Agency, shall maintain an agreement through 
which relevant laboratory network members, 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 re-
spond to foodborne illness outbreaks and facilitate the 
sharing of knowledge and information relating to ani-
mal health, agriculture, and human health; 
(2) identify means by which laboratory network 
members could work cooperatively— 
(A) to optimize national laboratory pre-
paredness; and 
(B) to provide surge capacity during emer-
gencies; and 
(3) engage in ongoing dialogue and build rela-
tionships that will support a more effective and inte-
grated response during emergencies. 
(b) REPORTING REQUIREMENT.—The Secretary of 
Homeland Security shall, on a biennial basis, submit to 
the relevant committees of Congress, and make publicly 
available on the Internet Web site of the Department of 
Homeland Security, a report on the progress of the inte-
grated consortium of laboratory networks, as established 
under subsection (a), in carrying out this section.
300 
SEC. 6204. 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 sec-
tion as the ‘‘Secretary’’), taking into account rec-
ommendations from the Secretary of Agriculture and 
representatives of State departments of health and ag-
riculture, shall establish pilot projects in coordination 
with the food industry to explore and evaluate meth-
ods to rapidly and effectively identify recipients of 
food to prevent or mitigate a foodborne illness out-
break and to address credible threats of serious ad-
verse health consequences or death to humans or ani-
mals 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 coordina-
tion with the processed food sector and 1 or more such 
pilot projects in coordination with processors or dis-
tributors of fruits and vegetables that are raw agricul-
tural commodities. The Secretary shall ensure that the 
pilot projects under paragraph (1) reflect the diver-
301 
sity 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 subsection (d). 
(3) REPORT.—Not later than 18 months after the 
date of enactment of this Act, the Secretary shall re-
port 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 coordina-
tion with the Secretary of Agriculture and multiple 
representatives of State departments of health and ag-
riculture, shall assess—
302 
(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 compat-
ible with the requirements of this subsection. 
(2) REQUIREMENTS.—To the extent practicable, 
in carrying out paragraph (1), the Secretary shall— 
(A) evaluate domestic and international 
product tracing practices in commercial use; 
(B) consider international efforts, including 
an assessment of whether product tracing re-
quirements developed under this section are com-
patible with global tracing systems, as appro-
priate; and 
(C) consult with a diverse and broad range 
of experts and stakeholders, including representa-
tives of the food industry, agricultural producers, 
and nongovernmental organizations that rep-
resent the interests of consumers. 
(c) PRODUCT TRACING SYSTEM.—The Secretary, in 
consultation with the Secretary of Agriculture, shall, as ap-