In the Senate of the United States, 
December 19, 2010. 
Resolved, That the bill from the House of Representa-
tives (H.R. 2751) entitled ‘‘An Act to accelerate motor fuel 
savings nationwide and provide incentives to registered own-
ers of high polluting automobiles to replace such automobiles 
with new fuel efficient and less polluting automobiles.’’, do 
pass with the following 
AMENDMENTS: 
Strike all after the enacting clause and insert the 
following: 
SECTION 1. SHORT TITLE; REFERENCES; TABLE OF CON-
TENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘FDA Food Safety Modernization Act’’. 
(b) REFERENCES.—Except as otherwise specified, 
whenever in this Act an amendment is expressed in terms 
of an amendment to a section or other provision, the ref-
erence shall be considered to be made to a section or other
† HR 2751 EAS 
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 Act is as follows: 
Sec. 1. Short title; references; table of contents. 
TITLE I—IMPROVING CAPACITY TO PREVENT FOOD SAFETY 
PROBLEMS 
Sec. 101. Inspections of records. 
Sec. 102. Registration of food facilities. 
Sec. 103. Hazard analysis and risk-based preventive controls. 
Sec. 104. Performance standards. 
Sec. 105. Standards for produce safety. 
Sec. 106. Protection against intentional adulteration. 
Sec. 107. Authority to collect fees. 
Sec. 108. National agriculture and food defense strategy. 
Sec. 109. Food and Agriculture Coordinating Councils. 
Sec. 110. Building domestic capacity. 
Sec. 111. Sanitary transportation of food. 
Sec. 112. Food allergy and anaphylaxis management. 
Sec. 113. New dietary ingredients. 
Sec. 114. Requirement for guidance relating to post harvest processing of raw oys-
ters. 
Sec. 115. Port shopping. 
Sec. 116. Alcohol-related facilities. 
TITLE II—IMPROVING CAPACITY TO DETECT AND RESPOND TO 
FOOD SAFETY PROBLEMS 
Sec. 201. Targeting of inspection resources for domestic facilities, foreign facili-
ties, and ports of entry; annual report. 
Sec. 202. Laboratory accreditation for analyses of foods. 
Sec. 203. Integrated consortium of laboratory networks. 
Sec. 204. Enhancing tracking and tracing of food and recordkeeping. 
Sec. 205. Surveillance. 
Sec. 206. Mandatory recall authority. 
Sec. 207. Administrative detention of food. 
Sec. 208. Decontamination and disposal standards and plans. 
Sec. 209. Improving the training of State, local, territorial, and tribal food safety 
officials. 
Sec. 210. Enhancing food safety. 
Sec. 211. Improving the reportable food registry. 
TITLE III—IMPROVING THE SAFETY OF IMPORTED FOOD 
Sec. 301. Foreign supplier verification program. 
Sec. 302. Voluntary qualified importer program. 
Sec. 303. Authority to require import certifications for food. 
Sec. 304. Prior notice of imported food shipments. 
Sec. 305. Building capacity of foreign governments with respect to food safety. 
Sec. 306. Inspection of foreign food facilities.
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Sec. 307. Accreditation of third-party auditors. 
Sec. 308. Foreign offices of the Food and Drug Administration. 
Sec. 309. Smuggled food. 
TITLE IV—MISCELLANEOUS PROVISIONS 
Sec. 401. Funding for food safety. 
Sec. 402. Employee protections. 
Sec. 403. Jurisdiction; authorities. 
Sec. 404. Compliance with international agreements. 
Sec. 405. Determination of budgetary effects. 
TITLE I—IMPROVING CAPACITY 
TO PREVENT FOOD SAFETY 
PROBLEMS 
SEC. 101. INSPECTIONS OF RECORDS. 
(a) IN GENERAL.—Section 414(a) (21 U.S.C. 350c(a)) 
is amended— 
(1) by striking the 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 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:
† HR 2751 EAS 
‘‘(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 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,
† HR 2751 EAS 
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 
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. 102. 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’’;
† HR 2751 EAS 
(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 
that has submitted a registration under paragraph 
(1) shall submit to the Secretary a renewal registra-
tion containing the information described in para-
graph (2). The Secretary shall provide for an abbre-
viated registration renewal process for any registrant 
that has not had any changes to such information 
since the registrant submitted the preceding registra-
tion 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 registration 
shall contain an assurance that the Secretary 
will be permitted to inspect such facility at the 
times and in the manner permitted by this 
Act.’’;
† HR 2751 EAS 
(B) by redesignating subsections (b) and (c) 
as subsections (c) and (d), respectively; and 
(C) by inserting after subsection (a) the fol-
lowing: 
‘‘(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 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
† HR 2751 EAS 
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.— 
‘‘(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-
† HR 2751 EAS 
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-
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
† HR 2751 EAS 
‘‘(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.’’. 
(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 in 1.227(b)(11) of title
† HR 2751 EAS 
21, Code of Federal Regulations to clarify that, in de-
termining the primary function of an establishment 
or a retail food establishment under such section, the 
sale of food products directly to consumers by such es-
tablishment and the sale of food directly to consumers 
by such retail food establishment include— 
(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
† HR 2751 EAS 
(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,’’. 
(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. 103. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE 
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-
† HR 2751 EAS 
‘‘(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 
‘‘(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 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 failure; 
‘‘(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 affected 
food is not adulterated under section 402 or mis-
branded under section 403(w).
† HR 2751 EAS 
‘‘(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 ap-
propriate decisions about corrective actions taken 
under subsection (e); 
‘‘(4) the preventive controls implemented under 
subsection (c) are effectively and significantly mini-
mizing or preventing the occurrence of identified haz-
ards, 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), instances of non-
† HR 2751 EAS 
conformance material to food safety, the results of testing 
and other appropriate means of verification under sub-
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
† HR 2751 EAS 
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 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.
† HR 2751 EAS 
‘‘(C) The Thermally Processed Low-Acid 
Foods Packaged in Hermetically Sealed Con-
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-
† HR 2751 EAS 
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, 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
† HR 2751 EAS 
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-
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—
† HR 2751 EAS 
‘‘(A) shall not be subject to the requirements 
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 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
† HR 2751 EAS 
qualified facility under paragraph (1)(B) or 
(1)(C). 
‘‘(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 qualified facility sub-
ject to an exemption under this subsection, or if 
the Secretary determines that it is necessary to 
protect the public health and prevent or mitigate 
a foodborne illness outbreak based on conduct or 
conditions associated with a qualified facility 
that are material to the safety of the food manu-
factured, processed, packed, or held at such facil-
ity, the Secretary may withdraw 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 Secretary. 
‘‘(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 facil-
ity.
† HR 2751 EAS 
‘‘(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 
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.
† HR 2751 EAS 
‘‘(5) STUDY.— 
‘‘(A) IN GENERAL.—The Secretary, in con-
sultation with the Secretary of Agriculture, shall 
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.
† HR 2751 EAS 
‘‘(B) SIZE.—The results of the study con-
ducted under subparagraph (A) shall include the 
information necessary to enable the Secretary to 
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
† HR 2751 EAS 
does not prepare documentation under para-
graph (2)(B)(i)(I) shall— 
‘‘(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
† HR 2751 EAS 
any label required under any other provision of 
this Act. 
‘‘(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).
† HR 2751 EAS 
‘‘(2) COORDINATION.—In promulgating the regu-
lations under paragraph (1)(A), with regard to haz-
ards that may be intentionally introduced, including 
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,
† HR 2751 EAS 
certify, or audit preventative controls, except in 
the case of negotiated enforcement resolutions 
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.
† HR 2751 EAS 
‘‘(2) FACILITY.—The term ‘facility’ means a do-
mestic facility or a foreign facility that is required to 
register under section 415. 
‘‘(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.
† HR 2751 EAS 
‘‘(E) A recall plan. 
‘‘(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,
† HR 2751 EAS 
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
† HR 2751 EAS 
(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 
201), 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-
† HR 2751 EAS 
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-
† HR 2751 EAS 
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-
† HR 2751 EAS 
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.
† HR 2751 EAS 
(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. 104. 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.
† HR 2751 EAS 
(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.
† HR 2751 EAS 
SEC. 105. STANDARDS FOR PRODUCE SAFETY. 
(a) IN GENERAL.—Chapter IV (21 U.S.C. 341 et seq.), 
as amended by section 103, 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.
† HR 2751 EAS 
‘‘(B) DETERMINATION
BY
SECRETARY.— 
With respect to small businesses and very small 
businesses (as such terms are defined in the regu-
lation promulgated under subparagraph (A)) 
that produce and harvest those types of fruits 
and vegetables that are raw agricultural com-
modities that the Secretary has determined are 
low risk and do not present a risk of serious ad-
verse health consequences or death, the Secretary 
may determine not to include production and 
harvesting of such fruits and vegetables in such 
rulemaking, or may modify the applicable re-
quirements of regulations promulgated pursuant 
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 
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 vege-
† HR 2751 EAS 
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
† HR 2751 EAS 
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.
† HR 2751 EAS 
‘‘(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.—
† HR 2751 EAS 
‘‘(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-
† HR 2751 EAS 
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, certify, compliance with these procedures, 
processes, and practices, except in the case of ne-
gotiated enforcement resolutions that may re-
quire 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-
† HR 2751 EAS 
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-
† HR 2751 EAS 
terated under section 402 and is not reasonably 
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 revoke 
a variance if the Secretary determines that 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 requirements 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 department des-
ignated 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 con-
sultation with the Secretary of Agriculture, represent-
† HR 2751 EAS 
atives of State departments of agriculture, farmer 
representatives, and various types of entities engaged 
in the production and harvesting or importing of 
fruits and vegetables that are raw agricultural com-
modities, including small businesses, updated good 
agricultural practices and guidance for the safe pro-
duction and harvesting of specific types of fresh 
produce under this section. 
‘‘(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 regarding 
the guidance described in paragraph (1) for persons 
in different regions who are involved in the produc-
tion and harvesting of fruits and vegetables that are 
raw agricultural commodities, including persons that 
sell directly to consumers and farmer representatives, 
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 prac-
ticable for all sizes and types of facilities, includ-
† HR 2751 EAS 
ing small businesses such as a small food proc-
essing 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 calendar 
year if— 
‘‘(A) during the previous 3-year period, the 
average annual monetary value of the food sold 
by such farm directly to qualified end-users dur-
ing 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 Sec-
retary under any other provision of this 
Act, include prominently and conspicuously
† HR 2751 EAS 
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 documents delivered contem-
poraneously 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
† HR 2751 EAS 
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.
† HR 2751 EAS 
‘‘(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-
† HR 2751 EAS 
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 103, 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. 106. PROTECTION AGAINST INTENTIONAL ADULTERA-
TION. 
(a) IN GENERAL.—Chapter IV (21 U.S.C. 341 et seq.), 
as amended by section 105, is amended by adding at the 
end the following:
† HR 2751 EAS 
‘‘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
† HR 2751 EAS 
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.
† HR 2751 EAS 
‘‘(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);
† HR 2751 EAS 
(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 105, is amended by adding 
at the end the following: 
‘‘(ww) The failure to comply with section 420.’’.
† HR 2751 EAS 
SEC. 107. 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;
† HR 2751 EAS 
‘‘(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-
† HR 2751 EAS 
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
† HR 2751 EAS 
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
† HR 2751 EAS 
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) RECOUPMENT.—In estab-
lishing the fee amounts under subpara-
graph (A)(iii) for the first 5 fiscal 
years after the date of enactment of 
this section, the Secretary shall include 
in such fee a reasonable surcharge that 
provides a recoupment of the costs ex-
pended by the Secretary to establish 
and implement the first year of the 
program under section 806. 
‘‘(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.
† HR 2751 EAS 
‘‘(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 
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
† HR 2751 EAS 
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— 
‘‘(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,
† HR 2751 EAS 
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.— 
‘‘(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-
† HR 2751 EAS 
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 
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
† HR 2751 EAS 
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-
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’’;
† HR 2751 EAS 
(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: 
‘‘(C) For purposes of this paragraph, a cer-
tification by the Secretary shall be made on such 
basis, and in such form (including a publicly 
available listing) as the Secretary determines ap-
propriate.’’. 
(3) LIMITATIONS ON THE 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 sub-
paragraph (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 
Administration 
associated 
with 
issuing such certifications.
† HR 2751 EAS 
‘‘(ii) Such fees may not be retained in 
an amount that exceeds such costs for the 
respective fiscal year.’’ 
SEC. 108. 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 
available on the Internet Web sites of the Department 
of Health and Human Services and the Department 
of Agriculture, the National Agriculture and Food De-
fense Strategy. 
(2) IMPLEMENTATION PLAN.—The strategy shall 
include an implementation plan for use by the Secre-
taries described under paragraph (1) in carrying out 
the strategy. 
(3) RESEARCH.—The strategy shall include a co-
ordinated research agenda for use by the Secretaries 
described under paragraph (1) in conducting research 
to support the goals and activities described in para-
graphs (1) and (2) of subsection (b).
† HR 2751 EAS 
(4) REVISIONS.—Not later than 4 years after the 
date on which the strategy is submitted to the relevant 
committees of Congress under paragraph (1), and not 
less frequently than every 4 years thereafter, the Sec-
retary of Health and Human Services and the Sec-
retary of Agriculture, in coordination with the Sec-
retary of Homeland Security, shall revise and submit 
to the relevant committees of Congress the strategy. 
(5) CONSISTENCY WITH EXISTING PLANS.—The 
strategy described in paragraph (1) shall be consistent 
with— 
(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—
† HR 2751 EAS 
(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: 
(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;
† HR 2751 EAS 
(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. 
(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
† HR 2751 EAS 
(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. 
(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—
† HR 2751 EAS 
(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 
(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
† HR 2751 EAS 
Homeland Security, and the Department of Agriculture, as 
described in subsection (a)(1). 
SEC. 109. 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 
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,
† HR 2751 EAS 
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. 110. BUILDING DOMESTIC CAPACITY. 
(a) IN GENERAL.— 
(1) INITIAL REPORT.—The Secretary, in coordi-
nation with the Secretary of Agriculture and the Sec-
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.
† HR 2751 EAS 
(B) Outreach to food industry sectors, in-
cluding through the Food and Agriculture Co-
ordinating Councils referred to in section 109, 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. 
(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 108 and 205.
† HR 2751 EAS 
(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 (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 201), together with, as nec-
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
† HR 2751 EAS 
(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. 
(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 202).
† HR 2751 EAS 
(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 
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
† HR 2751 EAS 
Act involving fruits and vegetables that are raw agricul-
tural commodities (as defined in section 201(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 
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,
† HR 2751 EAS 
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; 
(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-
† HR 2751 EAS 
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-
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. 111. 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
† HR 2751 EAS 
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. 112. 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.); 
(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;
† HR 2751 EAS 
(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-
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
† HR 2751 EAS 
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— 
(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;
† HR 2751 EAS 
(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 
anaphylaxis, including any procedures for the 
self-administration of medication by such chil-
dren in instances where— 
(i) the children are capable of self-ad-
ministering medication; and 
(ii) such administration is not prohib-
ited by State law. 
(C) Communication strategies between indi-
vidual schools or early childhood education pro-
grams and providers of emergency medical serv-
ices, including appropriate instructions for 
emergency medical response.
† HR 2751 EAS 
(D) Strategies to reduce the risk of exposure 
to anaphylactic causative agents in classrooms 
and common school or early childhood education 
program areas such as cafeterias. 
(E) The dissemination of general informa-
tion on life-threatening food allergies to school or 
early childhood education program staff, parents, 
and children. 
(F) Food allergy management training of 
school or early childhood education program per-
sonnel who regularly come into contact with chil-
dren with life-threatening food allergies. 
(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
† HR 2751 EAS 
school or early childhood education program, 
such as non-academic 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. 
(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
† HR 2751 EAS 
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. 
(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;
† HR 2751 EAS 
(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; 
(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-
† HR 2751 EAS 
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 
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
† HR 2751 EAS 
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 
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
† HR 2751 EAS 
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 
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
† HR 2751 EAS 
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-
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. 113. 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.—
† HR 2751 EAS 
‘‘(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-
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
† HR 2751 EAS 
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 
dietary ingredients, and appropriate methods for estab-
lishing the identify of a new dietary ingredient. 
SEC. 114. 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
† HR 2751 EAS 
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; 
(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
† HR 2751 EAS 
regulatory agencies, as appropriate, with regard to 
post harvest processing measures. 
(b) LIMITATION.—Subsection (a) shall not apply to the 
guidance described in section 103(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— 
(1) review and evaluate the report described in 
(a) and report to Congress on the findings of the esti-
mates 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 proc-
essing 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,
100 
† HR 2751 EAS 
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. 115. 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), the Secretary shall notify the Secretary of Homeland 
Security 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 Protec-
tion, may prevent food refused admittance into the United 
States by a United States port of entry from being admitted 
by another United States port of entry, through the notifica-
tion of other such United States ports of entry. 
SEC. 116. ALCOHOL-RELATED FACILITIES. 
(a) IN GENERAL.—Except as provided by sections 102, 
206, 207, 302, 304, 402, 403, and 404 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—
101 
† HR 2751 EAS 
(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 
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-AL-
COHOL FOOD.—Subsection (a) shall not apply to a facility 
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 distributes 
non-alcohol food, provided such food is received and distrib-
uted— 
(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.
102 
† HR 2751 EAS 
(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). 
TITLE II—IMPROVING CAPACITY 
TO DETECT AND RESPOND TO 
FOOD SAFETY PROBLEMS 
SEC. 201. TARGETING OF INSPECTION RESOURCES FOR DO-
MESTIC 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 106, 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
103 
† HR 2751 EAS 
of the facilities, which shall be based on the following 
factors: 
‘‘(A) The known safety risks of the food 
manufactured, processed, packed, or held at the 
facility. 
‘‘(B) The compliance history of a facility, 
including with regard to food recalls, outbreaks 
of foodborne illness, and violations of food safety 
standards. 
‘‘(C) The rigor and effectiveness of the 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-
104 
† HR 2751 EAS 
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 
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.—
105 
† HR 2751 EAS 
‘‘(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. 
‘‘(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 agreement, contract, 
memoranda of understanding, or other obliga-
tion. 
‘‘(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:
106 
† HR 2751 EAS 
‘‘(1) The known safety risks of the food imported. 
‘‘(2) The known safety risks of the countries or 
regions of origin and countries through which such 
article of food is transported. 
‘‘(3) The compliance history of the importer, 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.—
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† HR 2751 EAS 
‘‘(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 
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-
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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; 
‘‘(F) the sharing of information concerning 
observed non-compliance with United States food 
requirements domestically and in foreign nations 
and new regulatory decisions and policies that 
may affect the safety of food imported into the 
United States; 
‘‘(G) conducting joint training on subjects 
that affect and strengthen seafood inspection 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:
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‘‘(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 
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;
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‘‘(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-
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
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‘‘(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 
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. 202. LABORATORY ACCREDITATION FOR ANALYSES OF 
FOODS. 
(a) IN GENERAL.—Chapter IV (21 U.S.C. 341 et seq.), 
as amended by section 201, is amended by adding at the 
end the following: 
‘‘SEC. 422. LABORATORY ACCREDITATION FOR ANALYSES 
OF FOODS. 
‘‘(a) RECOGNITION
OF
LABORATORY
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—
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‘‘(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-
form testing under subparagraph (b) beyond the num-
ber 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
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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— 
‘‘(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—
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‘‘(A) shall periodically, and in no case less 
than once every 5 years, reevaluate accreditation 
bodies recognized under paragraph (1) and may 
accompany auditors from an accreditation body 
to assess whether the accreditation body meets 
the criteria for recognition; and 
‘‘(B) shall promptly revoke the recognition 
of any accreditation body found not to be in 
compliance with the requirements of this section, 
specifying, as appropriate, any terms and 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—
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‘‘(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 
‘‘(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—
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‘‘(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 
‘‘(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
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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 
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 between Federal 
agencies and State laboratories to develop national 
situational awareness; 
(3) provides accessible, timely, accurate, and 
consistent food laboratory services throughout the 
United States; 
(4) develops and implements a methods 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.
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(C) the Egg Products Inspection Act (21 
U.S.C. 1031 et seq.); 
(D) the United States Grain Standards Act 
(7 U.S.C. 71 et seq.); 
(E) the Packers and Stockyards Act, 1921 
(7 U.S.C. 181 et seq.); 
(F) the United States Warehouse Act (7 
U.S.C. 241 et seq.); 
(G) the Agricultural Marketing Act of 1946 
(7 U.S.C. 1621 et seq.); and 
(H) the Agricultural Adjustment Act (7 
U.S.C. 601 et seq.), reenacted with the amend-
ments made by the Agricultural Marketing 
Agreement Act of 1937; or 
(5) alter, impede, or affect the authority of the 
Secretary of Homeland Security under the Homeland 
Security Act of 2002 (6 U.S.C. 101 et seq.) or any 
other statute, including any authority related to se-
curing the borders of the United States, managing 
ports of entry, or agricultural import and entry in-
spection activities. 
SEC. 404. COMPLIANCE WITH INTERNATIONAL AGREE-
MENTS. 
Nothing in this Act (or an amendment made by this 
Act) shall be construed in a manner inconsistent with the