H. R. 2751 
One Hundred Eleventh Congress 
of the 
United States of America 
AT THE SECOND SESSION 
Begun and held at the City of Washington on Tuesday, 
the fifth day of January, two thousand and ten 
An Act 
To amend the Federal Food, Drug, and Cosmetic Act with respect to the safety 
of the food supply. 
Be it enacted by the Senate and House of Representatives of 
the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; REFERENCES; TABLE OF CONTENTS. 
(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 reference shall be considered 
to be made to a section or other provision of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). 
(c) TABLE OF CONTENTS.—The table of contents for this 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 facilities, 
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.
H. R. 2751—2 
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. 
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 believes is likely to be affected 
in a similar manner, is’’; 
(2) by inserting ‘‘, and to any other article of food that 
the Secretary reasonably believes is likely to be affected in 
a similar manner,’’ after ‘‘relating to such article’’; 
(3) by striking the last sentence; and 
(4) by inserting at the end the following: 
‘‘(2) USE OF OR EXPOSURE TO FOOD OF CONCERN.—If the 
Secretary believes that there is a reasonable 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 per-
son (excluding farms and restaurants) who manufactures, proc-
esses, packs, distributes, receives, holds, or imports such article 
shall, at the request of an officer or employee duly designated 
by the Secretary, permit such officer or employee, upon presen-
tation of appropriate credentials and a written notice to such 
person, at reasonable times and within reasonable limits and 
in a reasonable manner, to have access to and copy all records 
relating to such article and to any other article of food that 
the Secretary reasonably believes is likely to be affected in 
a similar manner, that are needed to assist the Secretary 
in determining whether there is a reasonable probability that 
the use of or exposure to the food will cause serious adverse 
health consequences or death to humans or animals. 
‘‘(3) APPLICATION.—The requirement under paragraphs (1) 
and (2) applies to all records relating to the manufacture, 
processing, packing, distribution, receipt, holding, or importa-
tion of such article maintained by or on behalf of such person
H. R. 2751—3 
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 inspection under paragraph (1) or (2) 
of section 414(a) applies, subject to’’. 
SEC. 102. REGISTRATION OF FOOD FACILITIES. 
(a) UPDATING OF FOOD CATEGORY REGULATIONS; BIENNIAL REG-
ISTRATION
RENEWAL.—Section 415(a) (21 U.S.C. 350d(a)) is 
amended— 
(1) in paragraph (2), by— 
(A) striking ‘‘conducts business and’’ and inserting ‘‘con-
ducts 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 deter-
mined appropriate by the Secretary, including by guidance’’ 
after ‘‘Code of Federal Regulations’’; 
(2) by redesignating paragraphs (3) and (4) as paragraphs 
(4) and (5), respectively; and 
(3) by inserting after paragraph (2) the following: 
‘‘(3) BIENNIAL REGISTRATION RENEWAL.—During the period 
beginning on October 1 and ending on December 31 of each 
even-numbered year, a registrant that has submitted a registra-
tion under paragraph (1) shall submit to the Secretary a 
renewal registration containing the information described in 
paragraph (2). The Secretary shall provide for an abbreviated 
registration renewal process for any registrant that has not 
had any changes to such information since the registrant sub-
mitted the preceding registration or registration renewal for 
the facility involved.’’. 
(b) SUSPENSION OF REGISTRATION.— 
(1) IN
GENERAL.—Section 415 (21 U.S.C. 350d) is 
amended— 
(A) in subsection (a)(2), by inserting after the first 
sentence the following: ‘‘The 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.’’; 
(B) by redesignating subsections (b) and (c) as sub-
sections (c) and (d), respectively; and 
(C) by inserting after subsection (a) the following: 
‘‘(b) SUSPENSION OF REGISTRATION.— 
‘‘(1) IN GENERAL.—If the Secretary determines that food 
manufactured, processed, packed, received, or held by a facility 
registered under this section has a reasonable probability of 
causing serious adverse health consequences or death to 
humans or animals, the Secretary may by order suspend the 
registration of a facility— 
‘‘(A) that created, caused, or was otherwise responsible 
for such reasonable probability; or 
‘‘(B)(i) that knew of, or had reason to know of, such 
reasonable probability; and 
‘‘(ii) packed, received, or held such food.
H. R. 2751—4 
‘‘(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 Secretary and the registrant, on the actions required for 
reinstatement of registration and why the registration that 
is subject to suspension should be reinstated. The Secretary 
shall reinstate a registration if the Secretary determines, based 
on evidence presented, that adequate grounds do not exist 
to continue the suspension of the registration. 
‘‘(3) POST-HEARING CORRECTIVE ACTION PLAN; VACATING OF 
ORDER.— 
‘‘(A) CORRECTIVE
ACTION
PLAN.—If, after providing 
opportunity for an informal hearing under paragraph (2), 
the Secretary determines that the suspension of registra-
tion remains necessary, 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 review such plan 
not later than 14 days after the submission of the corrective 
action plan or such other time period as determined by 
the Secretary. 
‘‘(B) VACATING OF ORDER.—Upon a determination by 
the Secretary that adequate grounds do not exist to con-
tinue 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 facility subject to the order or modify the order, 
as appropriate. 
‘‘(4) EFFECT OF SUSPENSION.—If the registration 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 otherwise introduce food from such facility into 
interstate or intrastate commerce in the United States. 
‘‘(5) REGULATIONS.— 
‘‘(A) IN
GENERAL.—The Secretary shall promulgate 
regulations to implement this subsection. The Secretary 
may promulgate such regulations on an interim final basis. 
‘‘(B) REGISTRATION REQUIREMENT.—The Secretary may 
require that registration under this section be submitted 
in an electronic 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 beginning on the earlier of— 
‘‘(A) the date on which the Secretary issues regulations 
under paragraph (5); or 
‘‘(B) 180 days after the date of enactment of the FDA 
Food Safety Modernization Act. 
‘‘(7) NO DELEGATION.—The authority conferred by this sub-
section to issue an order to suspend a registration or vacate 
an order of suspension shall not be delegated to any officer 
or employee other than the Commissioner.’’. 
(2) SMALL ENTITY COMPLIANCE POLICY GUIDE.—Not later 
than 180 days after the issuance of the regulations promulgated
H. R. 2751—5 
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 lan-
guage 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 registration has been 
suspended under such section)’’ after ‘‘section 415’’. 
(c) CLARIFICATION OF INTENT.— 
(1) RETAIL
FOOD
ESTABLISHMENT.—The Secretary shall 
amend the definition of the term ‘‘retail food establishment’’ 
in section in 1.227(b)(11) of title 21, Code of Federal Regulations 
to clarify that, in determining the primary function of an 
establishment or a retail food establishment under such section, 
the sale of food products directly to consumers by such 
establishment and the sale of food directly to consumers by 
such retail food establishment include— 
(A) the sale of such food products or food directly 
to consumers by such establishment at a roadside stand 
or farmers’ market where such stand or market is located 
other than where the food was manufactured or processed; 
(B) the sale and distribution of such food through a 
community supported agriculture program; and 
(C) the sale and distribution of such food at any other 
such direct sales platform as determined by the Secretary. 
(2) DEFINITIONS.—For purposes of paragraph (1)— 
(A) the term ‘‘community supported agriculture pro-
gram’’ 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 regu-
lation); and 
(B) the term ‘‘consumer’’ does not include a business. 
(d) CONFORMING AMENDMENTS.— 
(1) Section 301(d) (21 U.S.C. 331(d)) is amended by 
inserting ‘‘415,’’ after ‘‘404,’’. 
(2) Section 415(d), as redesignated by 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 CON-
TROLS. 
(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 PREVENTIVE CON-
TROLS. 
‘‘(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 implement preventive controls 
to significantly minimize or prevent the occurrence of such hazards 
and provide assurances that such food is not adulterated under 
section 402 or misbranded under section 403(w), monitor the 
performance of those controls, and maintain records of this moni-
toring as a matter of routine practice.
H. R. 2751—6 
‘‘(b) HAZARD ANALYSIS.—The owner, operator, or agent in charge 
of a facility shall— 
‘‘(1) identify and evaluate known or reasonably foreseeable 
hazards that may be associated with the facility, including— 
‘‘(A) biological, chemical, physical, and radiological haz-
ards, natural toxins, pesticides, drug residues, decomposi-
tion, parasites, allergens, and unapproved food and color 
additives; and 
‘‘(B) hazards that occur naturally, or may be uninten-
tionally introduced; and 
‘‘(2) identify and evaluate hazards that may be intentionally 
introduced, including by acts of terrorism; and 
‘‘(3) develop a written analysis of the hazards. 
‘‘(c) PREVENTIVE CONTROLS.—The owner, operator, or agent in 
charge of a facility shall identify and implement preventive controls, 
including at critical control points, if any, to provide assurances 
that— 
‘‘(1) hazards identified in the hazard analysis conducted 
under subsection (b)(1) will be significantly minimized or pre-
vented; 
‘‘(2) any hazards identified in the hazard analysis conducted 
under subsection (b)(2) will be significantly minimized or pre-
vented and addressed, consistent with section 420, as 
applicable; and 
‘‘(3) the food manufactured, processed, packed, or held by 
such facility will not be adulterated under section 402 or mis-
branded 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 described 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 com-
merce if the owner, operator or agent in charge of such facility 
cannot ensure that the affected food is not adulterated under 
section 402 or misbranded under section 403(w). 
‘‘(f) VERIFICATION.—The owner, operator, or agent in charge 
of a facility shall verify that— 
‘‘(1) the preventive controls implemented under subsection 
(c) are adequate to control the hazards identified under sub-
section (b); 
‘‘(2) the owner, operator, or agent is conducting monitoring 
in accordance with subsection (d); 
‘‘(3) the owner, operator, or agent is making appropriate 
decisions about corrective actions taken under subsection (e); 
‘‘(4) the preventive controls implemented under subsection 
(c) are effectively and significantly minimizing or preventing 
the occurrence of identified hazards, including through the 
use of environmental and product testing programs and other 
appropriate means; and
H. R. 2751—7 
‘‘(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 nonconformance material to food 
safety, the results of testing and other appropriate means of 
verification under subsection (f)(4), instances when corrective 
actions were implemented, and the efficacy of preventive controls 
and corrective actions. 
‘‘(h) WRITTEN PLAN AND DOCUMENTATION.—The owner, oper-
ator, or agent in charge of a facility shall prepare a written plan 
that documents and describes the procedures used by the facility 
to comply with the requirements of this section, including analyzing 
the hazards under subsection (b) and identifying the preventive 
controls adopted under subsection (c) to address those hazards. 
Such written plan, together with the documentation described in 
subsection (g), shall be made promptly available to a duly authorized 
representative of the Secretary upon oral or written request. 
‘‘(i) REQUIREMENT TO REANALYZE.—The owner, operator, or 
agent in charge of a facility shall conduct a reanalysis under sub-
section (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 increase in a previously identified hazard or not 
less frequently than once every 3 years, whichever is earlier. Such 
reanalysis shall be completed and additional preventive controls 
needed to address the hazard identified, if any, shall be imple-
mented 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, 
results from the Department of Homeland Security biological, chem-
ical, radiological, or other terrorism risk assessment. 
‘‘(j) EXEMPTION FOR SEAFOOD, JUICE, AND LOW-ACID CANNED 
FOOD FACILITIES SUBJECT TO HACCP.— 
‘‘(1) IN GENERAL.—This section shall not apply to a facility 
if the owner, operator, or agent in charge of such facility is 
required to comply with, and is in compliance with, 1 of the 
following standards and regulations with respect to such 
facility: 
‘‘(A) The Seafood Hazard Analysis Critical Control 
Points Program of the Food and Drug Administration. 
‘‘(B) The Juice Hazard Analysis Critical Control Points 
Program of the Food and Drug Administration. 
‘‘(C) The Thermally Processed Low-Acid Foods Pack-
aged in Hermetically Sealed Containers standards of the 
Food and Drug Administration (or any successor stand-
ards). 
‘‘(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
H. R. 2751—8 
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 SUBJECT TO SEC-
TION 419.—This section shall not apply to activities of a facility 
that are subject to section 419. 
‘‘(l) MODIFIED REQUIREMENTS FOR QUALIFIED FACILITIES.— 
‘‘(1) QUALIFIED FACILITIES.— 
‘‘(A) IN GENERAL.—A facility is a qualified facility for 
purposes of this subsection if the facility meets the condi-
tions under subparagraph (B) or (C). 
‘‘(B) VERY SMALL BUSINESS.—A facility is a qualified 
facility under this subparagraph— 
‘‘(i) if the facility, including any subsidiary or affil-
iate of the facility, is, collectively, 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 affiliates, collec-
tively, of any entity of which the facility is a sub-
sidiary or affiliate. 
‘‘(ii) AVERAGE
ANNUAL
MONETARY
VALUE.—This 
clause applies if— 
‘‘(I) during the 3-year period preceding the 
applicable calendar year, the average annual 
monetary value of the food manufactured, proc-
essed, packed, or held at such facility (or the collec-
tive 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, proc-
essed, packed, or held at such facility (or the collec-
tive average annual monetary value of such food 
at any subsidiary or affiliate, as so described) sold 
by such facility (or collectively by any such sub-
sidiary or affiliate) to all other purchasers during 
such period; and 
‘‘(II) the average annual monetary value of 
all food sold by such facility (or the collective aver-
age annual monetary value of such food sold by 
any subsidiary or affiliate, as described in clause 
(i)) during such period was less than $500,000, 
adjusted for inflation. 
‘‘(2) EXEMPTION.—A qualified facility— 
‘‘(A) shall not be subject to the requirements under 
subsections (a) through (i) and subsection (n) in an 
applicable calendar year; and 
‘‘(B) shall submit to the Secretary—
H. R. 2751—9 
‘‘(i)(I) documentation that demonstrates that the 
owner, operator, or agent in charge of the facility has 
identified potential hazards associated with the food 
being produced, is implementing preventive controls 
to address the hazards, and is monitoring the preven-
tive controls to ensure that such controls are effective; 
or 
‘‘(II) documentation (which may include licenses, 
inspection reports, certificates, permits, credentials, 
certification by an appropriate agency (such as a State 
department of agriculture), or other evidence of over-
sight), as specified by the Secretary, that the facility 
is in compliance with State, local, county, or other 
applicable non-Federal food safety law; and 
‘‘(ii) documentation, as specified by the Secretary 
in a guidance document issued not later than 1 year 
after the date of enactment of this section, that the 
facility is a qualified facility under paragraph (1)(B) 
or (1)(C). 
‘‘(3) WITHDRAWAL; RULE OF CONSTRUCTION.— 
‘‘(A) IN GENERAL.—In the event of an active investiga-
tion of a foodborne illness outbreak that is directly linked 
to a qualified facility subject to an exemption under this 
subsection, or if the Secretary determines that it is nec-
essary 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 manufactured, processed, packed, 
or held at such facility, the Secretary may withdraw the 
exemption provided to such facility under this subsection. 
‘‘(B) RULE
OF
CONSTRUCTION.—Nothing in this sub-
section 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 facility. 
‘‘(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 establishment (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 establishment; or 
‘‘(bb) not more than 275 miles from such 
facility; and 
‘‘(II) is purchasing the food for sale directly 
to consumers at such restaurant or retail food 
establishment. 
‘‘(C) CONSUMER.—For purposes of subparagraph (B), 
the term ‘consumer’ does not include a business. 
‘‘(D) SUBSIDIARY.—The term ‘subsidiary’ means any 
company which is owned or controlled directly or indirectly 
by another company.
H. R. 2751—10 
‘‘(5) STUDY.— 
‘‘(A) IN GENERAL.—The Secretary, in consultation with 
the Secretary of Agriculture, shall conduct a study of the 
food processing sector regulated by the Secretary to deter-
mine— 
‘‘(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 facilities co- 
located on farms, including the number and proportion 
by commodity and by manufacturing or processing 
activity; 
‘‘(iv) the incidence of foodborne illness originating 
from each size and type of operation 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 
agricultural 
commodities, 
including differences in risk based on the scale and 
duration of such activities. 
‘‘(B) SIZE.—The results of the study conducted 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 regulation under subsection (n). In defining such terms, 
the Secretary shall include consideration of harvestable 
acres, income, the number of employees, and the volume 
of food harvested. 
‘‘(C) SUBMISSION OF REPORT.—Not later than 18 months 
after the date of enactment the FDA Food Safety Mod-
ernization Act, the Secretary shall submit to Congress a 
report that describes the results of the study conducted 
under subparagraph (A). 
‘‘(6) NO PREEMPTION.—Nothing in this subsection preempts 
State, local, county, or other non-Federal law regarding the 
safe production of food. Compliance with this subsection shall 
not relieve any person from liability at common law or under 
State statutory law. 
‘‘(7) NOTIFICATION TO CONSUMERS.— 
‘‘(A) IN GENERAL.—A qualified facility that is exempt 
from the requirements under subsections (a) through (i) 
and subsection (n) and does not prepare documentation 
under paragraph (2)(B)(i)(I) shall— 
‘‘(i) with respect to a food for which a food pack-
aging label is required by the Secretary 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 pack-
aging 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
H. R. 2751—11 
food was manufactured or processed, on a label, poster, 
sign, placard, or documents delivered contempora-
neously with the food in the normal course of business, 
or, in the case of Internet sales, in an electronic notice. 
‘‘(B) NO ADDITIONAL LABEL.—Subparagraph (A) does 
not provide authority to the Secretary to require a label 
that is in addition to any label required under any other 
provision of this Act. 
‘‘(m) AUTHORITY WITH RESPECT TO CERTAIN FACILITIES.—The 
Secretary may, by regulation, exempt or modify the requirements 
for compliance under this section with respect to facilities that 
are solely engaged in the production of food for animals other 
than man, the storage of raw agricultural commodities (other than 
fruits and vegetables) intended for further distribution or proc-
essing, or the storage of packaged foods that are not exposed to 
the environment. 
‘‘(n) REGULATIONS.— 
‘‘(1) IN GENERAL.—Not later than 18 months after the date 
of enactment of the FDA Food Safety Modernization Act, the 
Secretary shall promulgate regulations— 
‘‘(A) to establish science-based minimum standards for 
conducting a hazard analysis, documenting hazards, imple-
menting 
preventive 
controls, 
and 
documenting 
the 
implementation of the preventive controls under this sec-
tion; and 
‘‘(B) to define, for purposes of this section, the terms 
‘small business’ and ‘very small business’, taking into 
consideration the study described in subsection (l)(5). 
‘‘(2) COORDINATION.—In promulgating the regulations 
under paragraph (1)(A), with regard to hazards that may be 
intentionally introduced, including by acts of terrorism, the 
Secretary shall coordinate with the Secretary of Homeland 
Security, as appropriate. 
‘‘(3) CONTENT.—The regulations promulgated under para-
graph (1)(A) shall— 
‘‘(A) provide sufficient flexibility to be practicable for 
all sizes and types of facilities, including small businesses 
such as a small food processing facility co-located on a 
farm; 
‘‘(B) comply with chapter 35 of title 44, United States 
Code (commonly known as the ‘Paperwork Reduction Act’), 
with special attention to minimizing the burden (as defined 
in section 3502(2) of such Act) on the facility, and collection 
of information (as defined in section 3502(3) of such Act), 
associated with such regulations; 
‘‘(C) acknowledge differences in risk and minimize, as 
appropriate, the number of separate standards that apply 
to separate foods; and 
‘‘(D) not require a facility to hire a consultant or other 
third party to identify, implement, 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 facility.
H. R. 2751—12 
‘‘(5) REVIEW.—In promulgating the regulations under para-
graph (1)(A), the Secretary shall review regulatory hazard anal-
ysis and preventive control programs in existence on the date 
of enactment of the FDA Food Safety Modernization Act, 
including the Grade ‘A’ Pasteurized Milk Ordinance to ensure 
that such regulations are consistent, to the extent practicable, 
with applicable domestic and internationally-recognized stand-
ards in existence on such date. 
‘‘(o) DEFINITIONS.—For purposes of this section: 
‘‘(1) CRITICAL CONTROL POINT.—The term ‘critical control 
point’ means a point, step, or procedure in a food process 
at which control can be applied and is essential to prevent 
or eliminate a food safety hazard or reduce such hazard to 
an acceptable level. 
‘‘(2) FACILITY.—The term ‘facility’ means a domestic facility 
or a foreign facility that is required to register under section 
415. 
‘‘(3) PREVENTIVE CONTROLS.—The term ‘preventive controls’ 
means those risk-based, reasonably appropriate 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 
identified 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, prac-
tices, 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 program to verify 
the effectiveness of pathogen controls in processes where 
a food is exposed to a potential contaminant in the environ-
ment. 
‘‘(D) A food allergen control program. 
‘‘(E) A recall plan. 
‘‘(F) Current Good Manufacturing Practices (cGMPs) 
under part 110 of title 21, Code of Federal Regulations 
(or any successor regulations). 
‘‘(G) Supplier verification activities that relate to the 
safety of food.’’. 
(b) GUIDANCE DOCUMENT.—The Secretary shall issue a guid-
ance document related to the regulations promulgated under sub-
section (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 Secretary of Health 
and Human Services (referred to in this subsection as 
the ‘‘Secretary’’) shall publish a notice of proposed rule-
making in the Federal Register to promulgate regulations 
with respect to— 
(i) activities that constitute on-farm packing or 
holding of food that is not grown, raised, or consumed
H. R. 2751—13 
on such farm or another farm under the same owner-
ship for purposes of section 415 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 350d), as amended 
by this Act; and 
(ii) activities that constitute on-farm manufac-
turing 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 described under 
subparagraph (A) shall enhance the implementation of such 
section 415 and clarify the activities that are included 
as part of the definition of the term ‘‘facility’’ under such 
section 415. Nothing in this Act authorizes the Secretary 
to modify the definition of the term ‘‘facility’’ under such 
section. 
(C) SCIENCE-BASED RISK ANALYSIS.—In promulgating 
regulations under subparagraph (A), the Secretary shall 
conduct a science-based risk analysis of— 
(i) specific types of on-farm packing or holding 
of food that is not grown, raised, or consumed on 
such farm or another farm under the same ownership, 
as such packing and holding relates to specific foods; 
and 
(ii) specific on-farm manufacturing and processing 
activities as such activities relate to specific foods that 
are not consumed 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 Cosmetic Act (as added by 
this section), including 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 determines appropriate, if such 
facilities are engaged only in specific types of on-farm 
manufacturing, processing, packing, or holding activi-
ties that the Secretary determines to be low risk 
involving specific foods the Secretary determines to 
be low risk. 
(ii) LIMITATION.—The exemptions or modifications 
under clause (i) shall not include 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 applicable, and shall apply 
only to small businesses and very small businesses, 
as defined in the regulation promulgated under section 
418(n) of the Federal Food, Drug, and Cosmetic Act 
(as added under subsection (a)). 
(2) FINAL REGULATIONS.—Not later than 9 months after 
the close of the comment period for the proposed rulemaking 
under paragraph (1), the Secretary shall adopt final rules with 
respect to—
H. R. 2751—14 
(A) 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 pur-
poses of section 415 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 350d), as amended by this Act; 
(B) 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; 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 Secretary 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 Federal Food, Drug, and Cos-
metic Act (as added by subsection (a)), the Secretary shall issue 
a small entity compliance policy guide setting forth in plain lan-
guage the requirements of such section 418 and this section to 
assist small entities in complying with the hazard analysis and 
other activities required under such section 418 and this section. 
(e) PROHIBITED ACTS.—Section 301 (21 U.S.C. 331) is amended 
by adding at the end the following: 
‘‘(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 authority of the Sec-
retary under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
301 et seq.) or the Public Health Service Act (42 U.S.C. 201 et 
seq.) to revise, issue, or enforce Hazard Analysis Critical Control 
programs and the Thermally Processed Low-Acid Foods Packaged 
in Hermetically Sealed Containers standards. 
(g) DIETARY SUPPLEMENTS.—Nothing in the amendments made 
by this section shall apply to any facility with regard to the manu-
facturing, processing, packing, or holding of a dietary supplement 
that is in compliance with the requirements of sections 402(g)(2) 
and 761 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
342(g)(2), 379aa–1). 
(h) UPDATING GUIDANCE RELATING
TO FISH
AND FISHERIES 
PRODUCTS HAZARDS AND CONTROLS.—The Secretary shall, not later 
than 180 days after the date of enactment of this Act, update 
the Fish and Fisheries Products Hazards and Control Guidance 
to take into account advances in technology that have occurred 
since the previous publication of such Guidance by the Secretary. 
(i) EFFECTIVE DATES.— 
(1) GENERAL RULE.—The amendments made by this section 
shall take effect 18 months after the date of enactment of 
this Act. 
(2) FLEXIBILITY FOR SMALL BUSINESSES.—Notwithstanding 
paragraph (1)— 
(A) the amendments made by this section shall apply 
to a small business (as defined in the regulations promul-
gated under section 418(n) of the Federal Food, Drug, and 
Cosmetic Act (as added by this section)) beginning on the
H. R. 2751—15 
date that is 6 months after the effective date of such 
regulations; and 
(B) the amendments made by this section shall apply 
to a very small business (as defined in such regulations) 
beginning on the date that is 18 months after the effective 
date of such regulations. 
SEC. 104. PERFORMANCE STANDARDS. 
(a) IN GENERAL.—The Secretary shall, in coordination with 
the Secretary of Agriculture, not less frequently than every 2 years, 
review and evaluate relevant health data and other relevant 
information, including from toxicological and epidemiological studies 
and analyses, current Good Manufacturing Practices issued by the 
Secretary relating to food, and relevant recommendations of rel-
evant advisory committees, including the Food Advisory Committee, 
to determine the most significant foodborne contaminants. 
(b) GUIDANCE DOCUMENTS AND REGULATIONS.—Based on the 
review and evaluation conducted under subsection (a), and when 
appropriate to reduce the risk of serious illness or death to humans 
or animals or to prevent adulteration of the food under section 
402 of the Federal Food, Drug, or Cosmetic Act (21 U.S.C. 342) 
or to 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 guid-
ance documents, including guidance documents regarding action 
levels, or regulations. Such guidance, including guidance regarding 
action levels, or regulations— 
(1) shall apply to products or product classes; 
(2) shall, where appropriate, differentiate between food for 
human consumption and food intended for consumption by ani-
mals other than humans; and 
(3) shall not be written to be facility-specific. 
(c) NO DUPLICATION OF EFFORTS.—The Secretary shall coordi-
nate 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, including guidance docu-
ments regarding action levels, or regulations promulgated under 
this section. 
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 coordination with the Secretary of 
Agriculture and representatives of State departments of 
agriculture (including with regard to the national organic 
program established under the Organic Foods Production 
Act of 1990), and in consultation with the Secretary of 
Homeland Security, shall publish a notice of proposed rule-
making to establish science-based minimum standards for 
the safe production and harvesting of those types of fruits
H. R. 2751—16 
and vegetables, including specific mixes or categories of 
fruits and vegetables, that are raw agricultural commod-
ities for which the Secretary has determined that such 
standards minimize the risk of serious adverse health con-
sequences or death. 
‘‘(B) DETERMINATION BY SECRETARY.—With respect to 
small businesses and very small businesses (as such terms 
are defined in the regulation promulgated under subpara-
graph (A)) that produce and harvest those types of fruits 
and vegetables that are raw agricultural commodities that 
the Secretary has determined are low risk and do not 
present a risk of serious adverse health consequences or 
death, the Secretary may determine not to include produc-
tion and harvesting of such fruits and vegetables in such 
rulemaking, or may modify the applicable requirements 
of regulations promulgated pursuant to this section. 
‘‘(2) PUBLIC INPUT.—During the comment period on the 
notice of proposed rulemaking under paragraph (1), the Sec-
retary 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 applicable to 
various types of entities engaged in the production and 
harvesting of fruits and vegetables that are raw agricul-
tural commodities, including small businesses and entities 
that sell directly to consumers, and be appropriate to the 
scale and diversity of the production and harvesting of 
such commodities; 
‘‘(B) include, with respect to growing, harvesting, 
sorting, packing, and storage operations, science-based min-
imum standards related to soil amendments, hygiene, pack-
aging, temperature controls, animals in the growing area, 
and water; 
‘‘(C) consider hazards that occur naturally, may be 
unintentionally introduced, or may be intentionally intro-
duced, including by acts of terrorism; 
‘‘(D) take into consideration, consistent with ensuring 
enforceable public health protection, 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 certified organic, 
not include any requirements that conflict with or duplicate 
the requirements of the national organic program estab-
lished under the Organic Foods Production Act of 1990, 
while providing the same level of public health protection 
as the requirements under guidance documents, including 
guidance documents regarding action levels, and regula-
tions 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
H. R. 2751—17 
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 rulemaking under sub-
section (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 commodities, 
based on known safety risks, which may include a history 
of foodborne illness outbreaks. 
‘‘(2) FINAL REGULATION.—The final regulation shall— 
‘‘(A) provide for coordination of education and enforce-
ment activities by State and local officials, as designated 
by the Governors of the respective States or the appropriate 
elected State official as recognized by State statute; and 
‘‘(B) include a description of the variance process under 
subsection (c) and the types of permissible variances the 
Secretary may grant. 
‘‘(3) FLEXIBILITY FOR SMALL BUSINESSES.—Notwithstanding 
paragraph (1)— 
‘‘(A) the regulations promulgated under this section 
shall apply to a small business (as defined in the regulation 
promulgated under subsection (a)(1)) after the date that 
is 1 year after the effective date of the final regulation 
under paragraph (1); and 
‘‘(B) the regulations promulgated under this section 
shall apply to a very small business (as defined in the 
regulation promulgated under subsection (a)(1)) after the 
date that is 2 years after the effective date of the final 
regulation under paragraph (1). 
‘‘(c) CRITERIA.— 
‘‘(1) IN
GENERAL.—The regulations adopted under sub-
section (b) shall— 
‘‘(A) set forth those procedures, processes, and practices 
that the Secretary determines to minimize the risk of 
serious adverse health consequences or death, including 
procedures, processes, and practices that the Secretary 
determines to be reasonably necessary to prevent the 
introduction of known or reasonably foreseeable biological, 
chemical, and physical hazards, including hazards that 
occur naturally, may be unintentionally introduced, or may 
be intentionally introduced, including by acts of terrorism, 
into fruits and vegetables, including specific mixes or cat-
egories of fruits and vegetables, that are raw agricultural 
commodities and to provide reasonable assurances that 
the produce is not adulterated under section 402; 
‘‘(B) provide sufficient flexibility to be practicable for 
all sizes and types of businesses, including small businesses 
such as a small food processing facility co-located on a 
farm; 
‘‘(C) comply with chapter 35 of title 44, United States 
Code (commonly known as the ‘Paperwork Reduction Act’), 
with special attention to minimizing the burden (as defined 
in section 3502(2) of such Act) on the business, and collec-
tion of information (as defined in section 3502(3) of such 
Act), associated with such regulations;
H. R. 2751—18 
‘‘(D) acknowledge differences in risk and minimize, 
as appropriate, the number of separate standards that 
apply to separate foods; and 
‘‘(E) not require a business to hire a consultant or 
other third party to identify, implement, certify, compliance 
with these procedures, processes, and practices, except in 
the case of negotiated enforcement resolutions that may 
require such a consultant or third party; and 
‘‘(F) permit States and foreign countries from which 
food is imported into the United States to request from 
the Secretary variances from the requirements of the regu-
lations, 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, proc-
esses, and practices to be followed under the variance are 
reasonably likely to ensure that the produce is not adulter-
ated under section 402 and to provide the same level of 
public health protection as the requirements of the regula-
tions adopted under subsection (b). 
‘‘(2) VARIANCES.— 
‘‘(A) REQUESTS
FOR
VARIANCES.—A State or foreign 
country from which food is imported into the United States 
may in writing request a variance from the Secretary. 
Such request shall describe the variance requested and 
present information demonstrating that the variance does 
not increase the likelihood that the food for which the 
variance is requested will be adulterated under section 
402, and that the variance provides the same level of 
public health protection as the requirements of the regula-
tions adopted under subsection (b). The Secretary shall 
review such requests in a reasonable timeframe. 
‘‘(B) APPROVAL
OF
VARIANCES.—The Secretary 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 Secretary may deny 
a variance request 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 regulation adopted under sub-
section (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 regu-
lations 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 designated by the Gov-
ernor of each State to perform activities to ensure compliance 
with this section. 
‘‘(e) GUIDANCE.—
H. R. 2751—19 
‘‘(1) IN GENERAL.—Not later than 1 year after the date 
of enactment of the FDA Food Safety Modernization Act, the 
Secretary shall publish, after consultation with the Secretary 
of Agriculture, representatives of State departments of agri-
culture, farmer representatives, and various types of entities 
engaged in the production and harvesting or importing of fruits 
and vegetables that are raw agricultural commodities, including 
small businesses, updated good agricultural practices and guid-
ance for the safe production 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 
production 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 practicable for 
all sizes and types of facilities, including small businesses 
such as a small food processing facility co-located on a 
farm; and 
‘‘(B) acknowledge differences in risk and minimize, as 
appropriate, the number of separate standards that apply 
to separate foods. 
‘‘(f) EXEMPTION FOR DIRECT FARM MARKETING.— 
‘‘(1) IN GENERAL.—A farm shall be exempt from the require-
ments 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 during such period exceeded 
the average annual monetary value of the food sold by 
such farm to all other buyers during such period; and 
‘‘(B) the average annual monetary value of all food 
sold during such period was less than $500,000, adjusted 
for inflation. 
‘‘(2) NOTIFICATION TO CONSUMERS.— 
‘‘(A) IN GENERAL.—A farm that is exempt from the 
requirements under this section shall— 
‘‘(i) with respect to a food for which a food pack-
aging label is required by the Secretary under any 
other provision of this Act, include prominently and 
conspicuously 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 pack-
aging 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 contemporaneously with the
H. R. 2751—20 
food in the normal course of business, or, in the case 
of Internet sales, in an electronic notice. 
‘‘(B) NO ADDITIONAL LABEL.—Subparagraph (A) does 
not provide authority to the Secretary to require a label 
that is in addition to any label required under any other 
provision of this Act. 
‘‘(3) WITHDRAWAL; RULE OF CONSTRUCTION.— 
‘‘(A) IN GENERAL.—In the event of an active investiga-
tion of a foodborne illness outbreak that is directly linked 
to a farm subject 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 ill-
ness outbreak based on conduct or conditions associated 
with a farm that are material to the safety of the food 
produced or harvested at such farm, the Secretary may 
withdraw the exemption provided to such farm under this 
subsection. 
‘‘(B) RULE
OF
CONSTRUCTION.—Nothing in this sub-
section shall be construed to expand or limit the inspection 
authority of the Secretary. 
‘‘(4) DEFINITIONS.— 
‘‘(A) QUALIFIED END-USER.—In this subsection, the term 
‘qualified end-user’, with respect to a food means— 
‘‘(i) the consumer of the food; or 
‘‘(ii) a restaurant or retail food establishment (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 pro-
duced the food; or 
‘‘(II) not more than 275 miles from such farm. 
‘‘(B) CONSUMER.—For purposes of subparagraph (A), 
the term ‘consumer’ does not include a business. 
‘‘(5) NO PREEMPTION.—Nothing in this subsection 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 consumption. 
‘‘(h) EXCEPTION FOR ACTIVITIES OF FACILITIES SUBJECT TO SEC-
TION 418.—This section shall not apply to activities of a facility 
that are subject to section 418.’’. 
(b) SMALL ENTITY COMPLIANCE POLICY GUIDE.—Not later than 
180 days after the issuance of regulations under section 419 of 
the Federal Food, Drug, and Cosmetic Act (as added by subsection 
(a)), the Secretary of Health and Human Services shall issue a 
small entity compliance policy guide setting forth in plain language 
the requirements of such section 419 and to assist small 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:
H. R. 2751—88 
SEC. 403. JURISDICTION; AUTHORITIES. 
Nothing in this Act, or an amendment made by this Act, shall 
be construed to— 
(1) alter the jurisdiction between the Secretary of Agri-
culture and the Secretary of Health and Human Services, under 
applicable statutes, regulations, or agreements regarding vol-
untary inspection of non-amenable species under the Agricul-
tural Marketing Act of 1946 (7 U.S.C. 1621 et seq.); 
(2) alter the jurisdiction between the Alcohol and Tobacco 
Tax and Trade Bureau and the Secretary of Health and Human 
Services, under applicable statutes and regulations; 
(3) limit the authority of the Secretary of Health and 
Human Services under— 
(A) the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.) as in effect on the day before the 
date of enactment of this Act; or 
(B) the Public Health Service Act (42 U.S.C. 301 et 
seq.) as in effect on the day before the date of enactment 
of this Act; 
(4) alter or limit the authority of the Secretary of Agri-
culture under the laws administered by such Secretary, 
including— 
(A) the Federal Meat Inspection Act (21 U.S.C. 601 
et seq.); 
(B) the Poultry Products Inspection Act (21 U.S.C. 
451 et seq.); 
(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 amendments made by the Agri-
cultural 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 securing the borders of the United 
States, managing ports of entry, or agricultural import and 
entry inspection activities. 
SEC. 404. COMPLIANCE WITH INTERNATIONAL AGREEMENTS. 
Nothing in this Act (or an amendment made by this Act) 
shall be construed in a manner inconsistent with the agreement 
establishing the World Trade Organization or any other treaty 
or international agreement to which the United States is a party. 
SEC. 405. DETERMINATION OF BUDGETARY EFFECTS. 
The budgetary effects of this Act, for the purpose of complying 
with the Statutory Pay-As-You-Go Act of 2010, shall be determined 
by reference to the latest statement titled ‘‘Budgetary Effects of 
PAYGO Legislation’’ for this Act, submitted for printing in the
H. R. 2751—89 
Congressional Record by the Chairman of the Senate Budget Com-
mittee, provided that such statement has been submitted prior 
to the vote on passage. 
Speaker of the House of Representatives. 
Vice President of the United States and
President of the Senate.