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•AMDT. NO. 4805 
‘‘(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 
inserting ‘‘$113,500,000 for fiscal year 2011’’; 
(B) in subparagraph (B) by striking 
‘‘$1,040,091,250 for the period beginning Octo-
ber 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 
inserting ‘‘$51,500,000 for fiscal year 2011’’; 
(D) in subparagraph (D) by striking 
‘‘$416,625,000 for the period beginning Octo-
ber 1, 2010 and ending December 31, 2010,’’ 
and inserting ‘‘$1,666,500,000 for fiscal year 
2011’’; 
(E) in subparagraph (E) by striking 
‘‘$246,000,000 for the period beginning Octo-
ber 1, 2010 and ending December 31, 2010,’’ 
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•AMDT. NO. 4805 
and inserting ‘‘$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 
inserting ‘‘$133,500,000 for fiscal year 2011’’; 
(G) in subparagraph (G) by striking 
‘‘$116,250,000 for the period beginning Octo-
ber 1, 2010 and ending December 31, 2010,’’ 
and inserting ‘‘$465,000,000 for fiscal year 
2011’’; 
(H) in subparagraph (H) by striking 
‘‘$41,125,000 for the period beginning October 
1, 2010 and ending December 31, 2010,’’ and 
inserting ‘‘$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 
inserting ‘‘$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 
inserting ‘‘$26,900,000 for fiscal year 2011’’; 
(K) in subparagraph (K) by striking 
‘‘$875,000 for the period beginning October 1, 
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•AMDT. NO. 4805 
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 
inserting ‘‘$25,000,000 for fiscal year 2011’’; 
(M) in subparagraph (M) by striking 
‘‘$116,250,000 for the period beginning Octo-
ber 1, 2010 and ending December 31, 2010,’’ 
and inserting ‘‘$465,000,000 for fiscal year 
2011’’; and 
(N) in subparagraph (N) by striking 
‘‘$2,200,000 for the period beginning October 
1, 2010 and ending December 31, 2010,’’ and 
inserting ‘‘$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-
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•AMDT. NO. 4805 
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 
(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) 
received sufficient funds in fiscal year 2010, or a 
previous fiscal year, to carry out the purpose for 
which the project or activity was authorized, the 
Secretary may not allocate any amounts under para-
graph (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.’’. 
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•AMDT. NO. 4805 
SEC. 537. AMENDMENTS TO SAFETEA–LU. 
(a) CONTRACTED
PARATRANSIT
PILOT.—Section 
3009(i)(1) of SAFETEA–LU (119 Stat. 1572) is amend-
ed by striking ‘‘2010, and for the period beginning Octo-
ber 1, 2010, and ending December 31, 2010’’ and insert-
ing ‘‘2011’’. 
(b) PUBLIC-PRIVATE
PARTNERSHIP
PILOT
PRO-
GRAM.—Section 3011 of SAFETEA–LU (49 U.S.C. 5309 
note; 119 Stat. 1588) is amended— 
(1) in subsection (c)(5) by striking ‘‘2010 and 
the period beginning October 1, 2010, and ending 
December 31, 2010’’ and inserting ‘‘2011’’; and 
(2) in subsection (d) by striking ‘‘2010, and for 
the period beginning October 1, 2010, and ending 
December 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 insert-
ing ‘‘September 30, 2011’’. 
(d) OBLIGATION
CEILING.—Section 3040(7) of 
SAFETEA–LU (119 Stat. 1639) is amended to read as 
follows: 
‘‘(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.’’. 
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•AMDT. NO. 4805 
(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 
(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 
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•AMDT. NO. 4805 
or other provision of the Federal Food, Drug, and Cos-
metic 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. 
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 fa-
cilities, 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 
safety 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. 
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•AMDT. NO. 4805 
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. 
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 
following: ‘‘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 reason-
ably believes is likely to be affected in a similar man-
ner, 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 
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•AMDT. NO. 4805 
(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 consequences or death to humans or animals, 
each person (excluding farms and restaurants) who 
manufactures, processes, packs, distributes, receives, 
holds, or imports such article shall, at the request of 
an officer or employee duly designated by the Sec-
retary, permit such officer or employee, upon presen-
tation of appropriate credentials and a written notice 
to such person, at reasonable times and within rea-
sonable 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 simi-
lar manner, that are needed to assist the Secretary 
in determining whether there is a reasonable prob-
ability that the use of or exposure to the food will 
cause serious adverse health consequences or death 
to humans or animals. 
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•AMDT. NO. 4805 
‘‘(3) APPLICATION.—The requirement under 
paragraphs (1) and (2) applies to all records relating 
to the manufacture, processing, packing, distribu-
tion, receipt, holding, or importation of such article 
maintained 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 414 when’’ and all that follows through 
‘‘subject to’’ and inserting ‘‘section 414, when the stand-
ard for records inspection under paragraph (1) or (2) of 
section 414(a) applies, subject to’’. 
SEC. 6102. REGISTRATION OF FOOD FACILITIES. 
(a) UPDATING OF FOOD CATEGORY REGULATIONS; 
BIENNIAL 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 cat-
egories as determined appropriate by the Sec-
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•AMDT. NO. 4805 
retary, including 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.— 
During the period beginning on October 1 and end-
ing on December 31 of each even-numbered year, a 
registrant that has submitted a registration under 
paragraph (1) shall submit to the Secretary a re-
newal registration containing the information de-
scribed in paragraph (2). The Secretary shall pro-
vide for an abbreviated registration renewal process 
for any registrant that has not had any changes to 
such information since the registrant submitted the 
preceding registration or registration renewal for the 
facility involved.’’. 
(b) SUSPENSION OF REGISTRATION.— 
(1) IN
GENERAL.—Section 415 (21 U.S.C. 
350d) is amended— 
(A) in subsection (a)(2), by inserting after 
the first sentence the following: ‘‘The registra-
tion shall contain an assurance that the Sec-
retary will be permitted to inspect such facility 
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•AMDT. NO. 4805 
at the times and in the manner permitted by 
this Act.’’; 
(B) by redesignating subsections (b) and 
(c) as subsections (c) and (d), respectively; and 
(C) by inserting after subsection (a) the 
following: 
‘‘(b) SUSPENSION OF REGISTRATION.— 
‘‘(1) IN GENERAL.—If the Secretary determines 
that food manufactured, processed, packed, received, 
or held by a facility registered under this section has 
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 in-
formal 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 
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•AMDT. NO. 4805 
by the Secretary 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 reg-
istration if the Secretary determines, based on evi-
dence presented, that adequate grounds do not exist 
to continue the suspension of the registration. 
‘‘(3) POST-HEARING CORRECTIVE ACTION PLAN; 
VACATING OF ORDER.— 
‘‘(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 reg-
istrant to submit a corrective action plan to 
demonstrate how the registrant plans to correct 
the conditions found by the Secretary. The Sec-
retary shall review such plan not later than 14 
days after the submission of the corrective ac-
tion plan or such other time period as deter-
mined by the Secretary. 
‘‘(B) VACATING OF ORDER.—Upon a de-
termination by the Secretary that adequate 
grounds do not exist to continue the suspension 
actions required by the order, or that such ac-
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•AMDT. NO. 4805 
tions should be modified, the Secretary shall 
promptly vacate the order and reinstate the reg-
istration of the facility 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 facil-
ity, or otherwise introduce food from such facility 
into interstate 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 
regulations on an interim final basis. 
‘‘(B) REGISTRATION REQUIREMENT.—The 
Secretary may require that registration under 
this section be submitted in an electronic for-
mat. Such requirement may not take effect be-
fore the date that is 5 years after the date of 
enactment of the FDA Food Safety Moderniza-
tion Act. 
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•AMDT. NO. 4805 
‘‘(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 con-
ferred by this subsection to issue an order to sus-
pend a registration or vacate an order of suspension 
shall not be delegated to any officer or employee 
other than the Commissioner.’’. 
(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 re-
quired under such section. 
(3) IMPORTED
FOOD.—Section 801(l) (21 
U.S.C. 381(l)) is amended by inserting ‘‘(or for 
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•AMDT. NO. 4805 
which a registration 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 
determining the primary function of an establish-
ment or a retail food establishment under such sec-
tion, the sale of food products directly to consumers 
by such establishment and the sale of food directly 
to consumers by such retail food establishment in-
clude— 
(A) the sale of such food products or food 
directly 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 
program; and 
(C) the sale and distribution of such food 
at any other such direct sales platform as deter-
mined by the Secretary. 
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•AMDT. NO. 4805 
(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 
regulation); and 
(B) the term ‘‘consumer’’ does not include 
a business. 
(d) CONFORMING AMENDMENTS.— 
(1) Section 301(d) (21 U.S.C. 331(d)) is 
amended by inserting ‘‘415,’’ after ‘‘404,’’. 
(2) Section 415(d), as redesignated by sub-
section (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: 
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•AMDT. NO. 4805 
‘‘SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVEN-
TIVE CONTROLS. 
‘‘(a) IN GENERAL.—The owner, operator, or agent 
in charge of a facility shall, in accordance with this sec-
tion, evaluate the hazards that could affect food manufac-
tured, processed, packed, or held by such facility, identify 
and implement preventive controls to significantly mini-
mize or prevent the occurrence of such hazards and pro-
vide assurances that such food is not adulterated under 
section 402 or misbranded under section 403(w), monitor 
the performance of those controls, and maintain records 
of this monitoring as a matter of routine practice. 
‘‘(b) HAZARD ANALYSIS.—The owner, operator, or 
agent in charge of a facility shall— 
‘‘(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 
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•AMDT. NO. 4805 
‘‘(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 imple-
ment 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 signifi-
cantly minimized or prevented; 
‘‘(2) any hazards identified in the hazard anal-
ysis conducted under subsection (b)(2) will be sig-
nificantly minimized or prevented and addressed, 
consistent with section 420, as applicable; and 
‘‘(3) the food manufactured, processed, packed, 
or held by such facility will not be adulterated under 
section 402 or misbranded under section 403(w). 
‘‘(d) MONITORING OF EFFECTIVENESS.—The owner, 
operator, or agent in charge of a facility shall monitor the 
effectiveness of the preventive controls implemented under 
subsection (c) to provide assurances that the outcomes de-
scribed in subsection (c) shall be achieved. 
‘‘(e) CORRECTIVE ACTIONS.—The owner, operator, 
or agent in charge of a facility shall establish procedures 
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•AMDT. NO. 4805 
to ensure that, if the preventive controls implemented 
under subsection (c) are not properly implemented or are 
found to be ineffective— 
‘‘(1) appropriate action is taken to reduce the 
likelihood of recurrence of the implementation fail-
ure; 
‘‘(2) all affected food is evaluated for safety; 
and 
‘‘(3) all affected food is prevented from entering 
into commerce if the owner, operator, or agent in 
charge of such facility cannot ensure that the af-
fected food is not adulterated under section 402 or 
misbranded under section 403(w). 
‘‘(f) VERIFICATION.—The owner, operator, or agent 
in charge of a facility shall verify that— 
‘‘(1) the preventive controls implemented under 
subsection (c) are adequate to control the hazards 
identified under subsection (b); 
‘‘(2) the owner, operator, or agent is conducting 
monitoring in accordance with subsection (d); 
‘‘(3) the owner, operator, or agent is making 
appropriate decisions about corrective actions taken 
under subsection (e); 
‘‘(4) the preventive controls implemented under 
subsection (c) are effectively and significantly mini-
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•AMDT. NO. 4805 
mizing or preventing the occurrence of identified 
hazards, including through the use of environmental 
and product testing programs and other appropriate 
means; and 
‘‘(5) there is documented, periodic reanalysis of 
the plan under subsection (i) to ensure that the plan 
is still relevant to the raw materials, conditions, and 
processes in the facility, and new and emerging 
threats. 
‘‘(g) RECORDKEEPING.—The owner, operator, or 
agent in charge of a facility shall maintain, for not less 
than 2 years, records documenting the monitoring of the 
preventive controls implemented under subsection (c), in-
stances of nonconformance material to food safety, the re-
sults of testing and other appropriate means of verification 
under subsection (f)(4), instances when corrective actions 
were implemented, and the efficacy of preventive controls 
and corrective 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 pro-
cedures used by the facility to comply with the require-
ments of this section, including analyzing the hazards 
under subsection (b) and identifying the preventive con-
trols adopted under subsection (c) to address those haz-
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•AMDT. NO. 4805 
ards. Such written plan, together with the documentation 
described in subsection (g), shall be made promptly avail-
able to a duly authorized representative of the Secretary 
upon oral or written request. 
‘‘(i) REQUIREMENT TO REANALYZE.—The owner, 
operator, or agent in charge of a facility shall conduct a 
reanalysis 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 sig-
nificant increase in a previously identified hazard or not 
less frequently than once every 3 years, whichever is ear-
lier. Such reanalysis shall be completed and additional pre-
ventive controls needed to address the hazard identified, 
if any, shall be implemented before the change in activities 
at the 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 reanaly-
sis under this section to respond to new hazards and devel-
opments in scientific understanding, including, as appro-
priate, results from the Department of Homeland Security 
biological, chemical, radiological, or other terrorism risk 
assessment. 
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•AMDT. NO. 4805 
‘‘(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 stand-
ards 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-
tainers standards of the Food and Drug Ad-
ministration (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). 
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•AMDT. NO. 4805 
‘‘(k) EXCEPTION
FOR ACTIVITIES
OF FACILITIES 
SUBJECT TO SECTION 419.—This section shall not apply 
to activities 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 quali-
fied facility for purposes of this subsection if 
the facility meets the conditions under subpara-
graph (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 
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, collec-
tively, a very small business (as so de-
fined). 
‘‘(C) LIMITED ANNUAL MONETARY VALUE 
OF SALES.— 
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•AMDT. NO. 4805 
‘‘(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 af-
filiate. 
‘‘(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 
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-
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•AMDT. NO. 4805 
tive average annual monetary value of 
such food at any subsidiary or affil-
iate, as so described) sold by such fa-
cility (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 require-
ments under subsections (a) through (i) and 
subsection (n) in an applicable calendar year; 
and 
‘‘(B) shall submit to the Secretary— 
‘‘(i)(I) 
documentation 
that 
dem-
onstrates that the owner, operator, or 
agent in charge of the facility has identi-
fied potential hazards associated with the 
food being produced, is implementing pre-
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•AMDT. NO. 4805 
ventive controls to address the hazards, 
and is monitoring 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 enactment of this section, that the facil-
ity is a qualified facility under paragraph 
(1)(B) or (1)(C). 
‘‘(3) 
WITHDRAWAL; 
RULE
OF
CONSTRUC-
TION.— 
‘‘(A) IN GENERAL.—In the event of an ac-
tive investigation of a foodborne illness out-
break that is directly linked to a qualified facil-
ity subject to an exemption under this sub-
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•AMDT. NO. 4805 
section, or if the Secretary determines that it is 
necessary to protect the public health and pre-
vent or mitigate a foodborne illness outbreak 
based on conduct or conditions associated with 
a qualified facility that are material to the safe-
ty of the food manufactured, processed, packed, 
or held at such facility, the Secretary may with-
draw the exemption provided to such facility 
under this subsection. 
‘‘(B) RULE OF CONSTRUCTION.—Nothing 
in this subsection shall be construed to expand 
or limit the inspection authority of the Sec-
retary. 
‘‘(4) DEFINITIONS.—In this subsection: 
‘‘(A) AFFILIATE.—The term ‘affiliate’ 
means any facility that controls, is controlled 
by, or is under common control with another fa-
cility. 
‘‘(B) QUALIFIED
END-USER.—The term 
‘qualified end-user’, with respect 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 
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•AMDT. NO. 4805 
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 sub-
paragraph (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 conduct a study of the food processing 
sector regulated by the Secretary to deter-
mine— 
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•AMDT. NO. 4805 
‘‘(i) the distribution of food produc-
tion by type and size of operation, includ-
ing 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 
facilities 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 op-
eration 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, proc-
essing, transporting, and storing food and 
raw agricultural commodities, including 
differences in risk based on the scale and 
duration of such activities. 
‘‘(B) SIZE.—The results of the study con-
ducted under subparagraph (A) shall include 
the information necessary to enable the Sec-
retary to define the terms ‘small business’ and 
‘very small business’, for purposes of promul-
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•AMDT. NO. 4805 
gating the regulation under subsection (n). In 
defining such terms, the Secretary shall include 
consideration of harvestable acres, income, the 
number of employees, 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 
describes 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 
subsections (a) through (i) and subsection (n) 
and does not prepare documentation under 
paragraph (2)(B)(i)(I) shall— 
‘‘(i) with respect to a food for which 
a food packaging label is required by the 
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•AMDT. NO. 4805 
Secretary under any other provision of this 
Act, include prominently and conspicuously 
on such label the name and business ad-
dress of the facility where the food was 
manufactured 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 docu-
ments delivered contemporaneously with 
the food in the normal course of business, 
or, in the case of Internet sales, in an elec-
tronic notice. 
‘‘(B) NO
ADDITIONAL
LABEL.—Subpara-
graph (A) does not provide authority to the 
Secretary to require a label that is in addition 
to any label required under any other provision 
of this Act. 
‘‘(m) AUTHORITY WITH RESPECT TO CERTAIN FA-
CILITIES.—The Secretary may, by regulation, exempt or 
modify the requirements for compliance under this section 
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•AMDT. NO. 4805 
with respect to facilities that are solely engaged in the pro-
duction of food for animals other than man, the storage 
of raw agricultural commodities (other than fruits and 
vegetables) intended 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, 
documenting hazards, implementing preventive 
controls, 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 reg-
ulations under paragraph (1)(A), with regard to haz-
ards that may be intentionally introduced, including 
by acts of terrorism, the Secretary shall coordinate 
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•AMDT. NO. 4805 
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 
practicable for all sizes and types of facilities, 
including small businesses such as a small food 
processing 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 
section 3502(2) of such Act) on the facility, and 
collection of information (as defined in section 
3502(3) of such Act), associated with such reg-
ulations; 
‘‘(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 con-
sultant or other third party to identify, imple-
ment, certify, or audit preventative controls, ex-
cept in the case of negotiated enforcement reso-
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•AMDT. NO. 4805 
lutions that may require such a consultant or 
third party. 
‘‘(4) RULE
OF
CONSTRUCTION.—Nothing in 
this subsection shall be construed to provide the Sec-
retary with the authority to prescribe specific tech-
nologies, practices, or critical controls for an indi-
vidual facility. 
‘‘(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 
practicable, with applicable domestic and inter-
nationally recognized standards in existence on such 
date. 
‘‘(o) DEFINITIONS.—For purposes of this section: 
‘‘(1) CRITICAL
CONTROL
POINT.—The term 
‘critical control point’ means a point, step, or proce-
dure in a food process at which control can be ap-
plied and is essential to prevent or eliminate a food 
safety hazard or reduce such hazard to an accept-
able level. 
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•AMDT. NO. 4805 
‘‘(2) FACILITY.—The term ‘facility’ means a 
domestic facility or a foreign facility that is required 
to register under section 415. 
‘‘(3) PREVENTIVE CONTROLS.—The term ‘pre-
ventive controls’ means those risk-based, reasonably 
appropriate procedures, practices, and processes that 
a person knowledgeable about the safe manufac-
turing, processing, packing, or holding of food would 
employ to significantly minimize or prevent the haz-
ards identified under the hazard analysis conducted 
under subsection (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 con-
tact surfaces and utensils and food-contact sur-
faces of equipment. 
‘‘(B) Supervisor, manager, and employee 
hygiene training. 
‘‘(C) An environmental monitoring pro-
gram to verify the effectiveness of pathogen 
controls in processes where a food is exposed to 
a potential contaminant in the environment. 
‘‘(D) A food allergen control program. 
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•AMDT. NO. 4805 
‘‘(E) A recall plan. 
‘‘(F) Current Good Manufacturing Prac-
tices (cGMPs) under part 110 of title 21, Code 
of Federal Regulations (or any successor regu-
lations). 
‘‘(G) Supplier verification activities that 
relate to the safety of food.’’. 
(b) GUIDANCE DOCUMENT.—The Secretary shall 
issue a guidance document related to the regulations pro-
mulgated under subsection (b)(1) with respect to the haz-
ard 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 Secretary of Health and Human Services 
(referred to in this subsection as the ‘‘Sec-
retary’’) shall publish a notice of proposed rule-
making 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 
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•AMDT. NO. 4805 
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; 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 pur-
poses of such section 415. 
(B) CLARIFICATION.—The rulemaking de-
scribed under subparagraph (A) shall enhance 
the implementation of such section 415 and 
clarify the activities that are included as part of 
the definition of the term ‘‘facility’’ under such 
section 415. Nothing in this Act authorizes the 
Secretary to modify the definition of the term 
‘‘facility’’ 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 an-
other farm under the same ownership, as 
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•AMDT. NO. 4805 
such packing and holding relates to spe-
cific foods; and 
(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 CER-
TAIN 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 Cosmetic Act (as added by this sec-
tion), including hazard analysis and pre-
ventive controls, and the mandatory in-
spection 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 determines appro-
priate, if such facilities are engaged only in 
specific types of on-farm manufacturing, 
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•AMDT. NO. 4805 
processing, packing, or holding activities 
that the Secretary determines 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 Fed-
eral Food, Drug, and Cosmetic Act (21 
U.S.C. 350d), as amended by this Act, if 
applicable, 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 Cosmetic 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 sec-
tion 415 of the Federal Food, Drug, and Cos-
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•AMDT. NO. 4805 
metic Act (21 U.S.C. 350d), as amended by 
this Act; 
(B) activities that constitute on-farm man-
ufacturing or processing of food that is not con-
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 Cos-
metic Act, as added by this Act, from which the 
Secretary may issue exemptions or modifica-
tions of the requirements for certain types of 
facilities. 
(d) SMALL ENTITY COMPLIANCE POLICY GUIDE.— 
Not later than 180 days after the issuance of the regula-
tions promulgated under subsection (n) of section 418 of 
the Federal 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 
requirements 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: 
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•AMDT. NO. 4805 
‘‘(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-
ity of the Secretary under the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health 
Service Act (42 U.S.C. 201 et seq.) to revise, issue, or 
enforce Hazard Analysis Critical Control programs and 
the Thermally Processed Low-Acid Foods Packaged in 
Hermetically Sealed Containers standards. 
(g) 
DIETARY
SUPPLEMENTS.—Nothing 
in 
the 
amendments made by this section shall apply to any facil-
ity with regard to the manufacturing, processing, packing, 
or holding 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 
Products Hazards and Control Guidance to take into ac-
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•AMDT. NO. 4805 
count advances in technology that have occurred since the 
previous 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. 
(2) FLEXIBILITY
FOR
SMALL
BUSINESSES.— 
Notwithstanding 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 Cos-
metic 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 
regulations. 
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-
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•AMDT. NO. 4805 
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 con-
taminants. 
(b) GUIDANCE DOCUMENTS AND REGULATIONS.— 
Based on the review and evaluation conducted under sub-
section (a), and when appropriate to reduce the risk of 
serious 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 pre-
vent 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, including 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 in-
tended for consumption by animals other than hu-
mans; and 
(3) shall not be written to be facility-specific. 
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•AMDT. NO. 4805 
(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, in-
cluding guidance documents regarding action levels, or 
regulations promulgated under this section. 
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 ag-
riculture (including with regard to the national 
organic program established under the Organic 
Foods Production Act of 1990), and in con-
sultation with the Secretary of Homeland Secu-
rity, shall publish a notice of proposed rule-
making to establish science-based minimum 
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•AMDT. NO. 4805 
standards for the safe production and har-
vesting of those types of fruits and vegetables, 
including specific mixes or categories of fruits 
and vegetables, that are raw agricultural com-
modities for which the Secretary has deter-
mined that such standards minimize the risk of 
serious adverse health consequences or death. 
‘‘(B) DETERMINATION
BY
SECRETARY.— 
With respect to small businesses and very small 
businesses (as such terms are defined in the 
regulation promulgated under subparagraph 
(A)) that produce and harvest those types of 
fruits and vegetables that are raw agricultural 
commodities that the Secretary has determined 
are low risk and do not present a risk of serious 
adverse health consequences or death, the Sec-
retary may determine not to include production 
and harvesting of such fruits and vegetables in 
such rulemaking, or may modify the applicable 
requirements of regulations promulgated pursu-
ant to this section. 
‘‘(2) PUBLIC INPUT.—During the comment pe-
riod on the notice of proposed rulemaking under 
paragraph (1), the Secretary shall conduct not less 
than 3 public meetings in diverse geographical areas 
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•AMDT. NO. 4805 
of the United States to provide persons in different 
regions an opportunity to comment. 
‘‘(3) CONTENT.—The proposed rulemaking 
under paragraph (1) shall— 
‘‘(A) provide sufficient flexibility to be ap-
plicable to various types of entities engaged in 
the production and harvesting of fruits and 
vegetables that are raw agricultural commod-
ities, including small businesses and entities 
that sell directly to consumers, and be appro-
priate to the scale and diversity of the produc-
tion and harvesting of such commodities; 
‘‘(B) include, with respect to growing, har-
vesting, sorting, packing, and storage oper-
ations, science-based minimum standards re-
lated 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 
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•AMDT. NO. 4805 
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 Organic Foods Production Act of 
1990, while providing the same level of public 
health protection as the requirements under 
guidance documents, including guidance docu-
ments 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 busi-
ness’. 
‘‘(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 sever-
ity of foodborne illness outbreaks. 
‘‘(b) FINAL REGULATION.— 
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•AMDT. NO. 4805 
‘‘(1) IN GENERAL.—Not later than 1 year after 
the close of the comment period for the proposed 
rulemaking 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 
include a history of foodborne illness outbreaks. 
‘‘(2) FINAL REGULATION.—The final regulation 
shall— 
‘‘(A) provide for coordination of education 
and enforcement activities by State and local 
officials, as designated by the Governors of the 
respective 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 
permissible 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 
defined in the regulation promulgated under 
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•AMDT. NO. 4805 
subsection (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 
subsection (a)(1)) after the date that is 2 years 
after the effective date of the final regulation 
under paragraph (1). 
‘‘(c) CRITERIA.— 
‘‘(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 deter-
mines to be reasonably necessary to prevent the 
introduction of known or reasonably foreseeable 
biological, chemical, and physical hazards, in-
cluding hazards that occur naturally, may be 
unintentionally introduced, or may be inten-
tionally introduced, including by acts of ter-
rorism, into fruits and vegetables, including 
specific mixes or categories of fruits and vegeta-
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•AMDT. NO. 4805 
bles, that are raw agricultural commodities and 
to provide reasonable assurances that the 
produce is not adulterated 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-
tion to minimizing the burden (as defined in 
section 3502(2) of such Act) on the business, 
and collection of information (as defined in sec-
tion 3502(3) of such Act), associated with such 
regulations; 
‘‘(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 
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•AMDT. NO. 4805 
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, sub-
ject to paragraph (2), where the State or for-
eign country determines that the variance is 
necessary in light of local growing conditions 
and that the procedures, processes, and prac-
tices to be followed under the variance are rea-
sonably likely to ensure that the produce is not 
adulterated under section 402 and to provide 
the same level of public 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 information demonstrating that the 
variance does not increase the likelihood that 
the food for which the variance is requested will 
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•AMDT. NO. 4805 
be adulterated under section 402, and that the 
variance provides the same level of public health 
protection as the requirements of the regula-
tions adopted under subsection (b). The Sec-
retary shall review such requests in a reason-
able 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 
adulterated under section 402 and is not rea-
sonably likely to provide the same level of public 
health protection as the requirements of the 
regulation adopted under subsection (b). The 
Secretary shall notify the person requesting 
such variance of the reasons for the denial. 
‘‘(D) MODIFICATION OR REVOCATION OF A 
VARIANCE.—The Secretary, after notice and an 
opportunity for a hearing, may modify or re-
voke a variance if the Secretary determines that 
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•AMDT. NO. 4805 
such variance is not reasonably likely to ensure 
that the food is not adulterated under section 
402 and is not reasonably likely to provide the 
same level of public health protection as the re-
quirements of the regulations adopted under 
subsection (b). 
‘‘(d) ENFORCEMENT.—The Secretary may coordinate 
with the Secretary of Agriculture and, as appropriate, 
shall contract and coordinate with the agency or depart-
ment designated by the Governor of each State to perform 
activities to ensure compliance with this section. 
‘‘(e) GUIDANCE.— 
‘‘(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of the FDA Food Safety Mod-
ernization Act, the Secretary shall publish, after 
consultation with the Secretary of Agriculture, rep-
resentatives of State departments of agriculture, 
farmer representatives, and various types of entities 
engaged in the production and harvesting or import-
ing of fruits and vegetables that are raw agricultural 
commodities, including small businesses, updated 
good agricultural practices and guidance for the safe 
production and harvesting of specific types of fresh 
produce under this section. 
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•AMDT. NO. 4805 
‘‘(2) PUBLIC MEETINGS.—The Secretary shall 
conduct not fewer than 3 public meetings in diverse 
geographical areas of the United States as part of 
an effort to conduct education and outreach regard-
ing the guidance described in paragraph (1) for per-
sons in different regions who are involved in the pro-
duction and harvesting of fruits and vegetables that 
are raw agricultural commodities, including persons 
that sell directly to consumers and farmer represent-
atives, and for importers of fruits and vegetables 
that are raw agricultural commodities. 
‘‘(3) PAPERWORK REDUCTION.—The Secretary 
shall ensure that any updated guidance under this 
section will— 
‘‘(A) provide sufficient flexibility to be 
practicable for all sizes and types of facilities, 
including small businesses such as a small food 
processing facility co-located on a farm; and 
‘‘(B) acknowledge differences in risk and 
minimize, as appropriate, the number of sepa-
rate standards that apply to separate foods. 
‘‘(f) EXEMPTION FOR DIRECT FARM MARKETING.— 
‘‘(1) IN
GENERAL.—A farm shall be exempt 
from the requirements under this section in a cal-
endar year if— 
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•AMDT. NO. 4805 
‘‘(A) during the previous 3-year period, the 
average annual monetary value of the food sold 
by such farm directly to qualified end-users 
during such period exceeded the average annual 
monetary value of the food sold by such farm 
to all other buyers during such period; and 
‘‘(B) the average annual monetary value of 
all food sold during such period was less than 
$500,000, adjusted for inflation. 
‘‘(2) NOTIFICATION TO CONSUMERS.— 
‘‘(A) IN GENERAL.—A farm that is exempt 
from the requirements under this section 
shall— 
‘‘(i) with respect to a food for which 
a food packaging label is required by the 
Secretary under any other provision of this 
Act, include prominently and conspicuously 
on such label the name and business ad-
dress 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 
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•AMDT. NO. 4805 
and business address of the farm where 
the produce was grown, on a label, poster, 
sign, placard, or document delivered con-
temporaneously with the food in the nor-
mal 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 
Secretary to require a label that is in addition 
to any label required under any other provision 
of this Act. 
‘‘(3) 
WITHDRAWAL; 
RULE
OF
CONSTRUC-
TION.— 
‘‘(A) IN GENERAL.—In the event of an ac-
tive investigation of a foodborne illness out-
break that is directly linked to a farm subject 
to an exemption under this subsection, or if the 
Secretary determines that it is necessary to pro-
tect the public health and prevent or mitigate 
a foodborne illness outbreak based on conduct 
or conditions associated with a farm that are 
material to the safety of the food produced or 
harvested at such farm, the Secretary may 
withdraw the exemption provided to such farm 
under this subsection. 
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•AMDT. NO. 4805 
‘‘(B) RULE OF CONSTRUCTION.—Nothing 
in this subsection shall be construed to expand 
or limit the inspection authority of the Sec-
retary. 
‘‘(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. 
‘‘(B) CONSUMER.—For purposes of sub-
paragraph (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, har-
vesting, holding, transportation, and sale of fresh 
fruits and vegetables. Compliance with this sub-
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•AMDT. NO. 4805 
section 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 exer-
cising 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 
consumption. 
‘‘(h) EXCEPTION
FOR ACTIVITIES
OF FACILITIES 
SUBJECT TO SECTION 418.—This section shall not apply 
to activities 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 Cos-
metic Act (as added by subsection (a)), the Secretary of 
Health and Human Services shall issue a small entity 
compliance policy guide setting forth in plain language the 
requirements of such section 419 and to assist small enti-
ties in complying with standards for safe production and 
harvesting and other activities required under such sec-
tion. 
(c) PROHIBITED ACTS.—Section 301 (21 U.S.C. 
331), as amended by section 6103, is amended by adding 
at the end the following: 
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•AMDT. NO. 4805 
‘‘(vv) The failure to comply with the requirements 
under section 419.’’. 
(d) NO EFFECT ON HACCP AUTHORITIES.—Noth-
ing in the amendments made by this section limits the au-
thority of the Secretary under the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public 
Health Service Act (42 U.S.C. 201 et seq.) to revise, issue, 
or enforce product and category-specific regulations, such 
as the Seafood Hazard Analysis Critical Controls Points 
Program, the Juice Hazard Analysis Critical Control Pro-
gram, and the Thermally Processed Low-Acid Foods 
Packaged in Hermetically Sealed Containers standards. 
SEC. 6106. PROTECTION AGAINST INTENTIONAL ADULTER-
ATION. 
(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: 
‘‘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 biologi-
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•AMDT. NO. 4805 
cal, chemical, radiological, or other terrorism 
risk assessments; 
‘‘(B) consider the best available under-
standing of uncertainties, risks, costs, and ben-
efits associated with guarding against inten-
tional 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 adul-
teration of food. 
‘‘(2) LIMITED DISTRIBUTION.—In the interest 
of national security, the Secretary, in consultation 
with the Secretary of Homeland Security, may deter-
mine the time, manner, and form in which deter-
minations made under paragraph (1) are made pub-
licly available. 
‘‘(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 
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— 
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•AMDT. NO. 4805 
ment of Agriculture, and the Department of Home-
land Security to achieve the following goals: 
(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 
decision 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 
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(III) the private sector. 
(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— 
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