I 
111TH CONGRESS 
1ST SESSION H. R. 1332 
To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
safety of the food supply. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 5, 2009 
Mr. COSTA (for himself, Mr. PUTNAM, Mr. PETERSON, Mr. DEAL of Georgia, 
Mr. CARDOZA, Mr. BARTON of Texas, Mr. FARR, Mr. SHIMKUS, Mr. 
ENGEL, Mr. RADANOVICH, Mr. THOMPSON of California, Mr. TERRY, Mr. 
SALAZAR, Mr. BOSWELL, Ms. HERSETH SANDLIN, Mr. WALDEN, Mr. 
CUELLAR, Mr. KAGEN, Mr. SCOTT of Georgia, Ms. ROS-LEHTINEN, Mr. 
BURGESS, and Mr. BACA) introduced the following bill; which was re-
ferred to the Committee on Energy and Commerce, and in addition to 
the Committee on Agriculture, for a period to be subsequently determined 
by the Speaker, in each case for consideration of such provisions as fall 
within the jurisdiction of the committee concerned 
A BILL 
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 Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; REFERENCES; TABLE OF CON-
TENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Safe Food Enforcement, Assessment, Standards, and 
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Targeting Act of 2009’’ or as the ‘‘Safe FEAST Act of 
2009’’. 
(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 construed 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 of 
this Act is as follows: 
Sec. 1. Short title; references; table of contents. 
TITLE I—GENERAL FOOD PROVISIONS 
Sec. 101. Inspection of records during food-related emergencies. 
Sec. 102. Registration of food facilities. 
Sec. 103. Mandatory recall authority. 
Sec. 104. Hazard analysis and risk-based preventive controls. 
Sec. 105. Performance standards. 
Sec. 106. Standards for the safety of fruits and vegetables. 
Sec. 107. Targeting of inspection resources for domestic facilities, foreign facili-
ties, and ports of entry; annual report. 
Sec. 108. Administrative detention of food. 
Sec. 109. National agriculture and food defense strategy. 
Sec. 110. Food and Agriculture Coordinating Councils. 
Sec. 111. Authority to collect fees. 
TITLE II—DETECTION AND SURVEILLANCE 
Sec. 201. Recognition of laboratory accreditation for analyses of foods. 
Sec. 202. Integrated consortium of laboratory networks. 
Sec. 203. Building domestic capacity. 
Sec. 204. Enhancing traceback and recordkeeping. 
Sec. 205. Surveillance. 
TITLE III—SPECIFIC PROVISIONS FOR 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. Review of a regulatory authority of a foreign country. 
Sec. 306. Building capacity of foreign governments with respect to food. 
Sec. 307. Inspection of foreign food facilities. 
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Sec. 308. Third-party accreditation of qualified auditors and audit agents. 
Sec. 309. Jurisdiction; authorities. 
TITLE I—GENERAL FOOD 
PROVISIONS 
SEC. 101. INSPECTION OF RECORDS DURING FOOD-RE-
LATED EMERGENCIES. 
(a) IN GENERAL.—Section 414 (21 U.S.C. 350c) is 
amended— 
(1) by redesignating subsections (b), (c), and 
(d) as subsections (c), (d), and (e), respectively; and 
(2) by inserting after subsection (a) the fol-
lowing: 
‘‘(b) RECORDS
INSPECTIONS
DURING
FOOD-RE-
LATED EMERGENCIES.—If the Secretary has a reasonable 
belief that an article of food presents a threat of serious 
adverse health consequences or death to humans or ani-
mals, during a food-related emergency, the Secretary— 
‘‘(1) may have access to and copy all records 
relating to such article of food in the same manner 
and for the same purpose as described in subsection 
(a); and 
‘‘(2) shall, from each person (excluding farms 
and restaurants) who manufactures, processes, 
packs, distributes, receives, holds, or imports an ar-
ticle of food related to the article of food referred to 
under paragraph (1) (such as an article of food pro-
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duced on the same manufacturing line or any other 
article of food that the Secretary reasonably believes 
is likely to be affected in a similar manner) at the 
request of an officer or employee duly designated by 
the Secretary, have permission for such officer or 
employee, upon presentation of appropriate creden-
tials and a written notice to such person, at reason-
able times and within reasonable limits and in a rea-
sonable manner, to have access to and copy all 
records relating to such article that are needed to 
assist the Secretary in determining whether the food 
presents a threat of serious adverse health con-
sequences or death to humans or animals.’’. 
(b) CONFORMING AMENDMENTS.— 
(1) Section 301(e) (21 U.S.C. 331(e)) is 
amended 
by 
striking 
‘‘414(b)’’ 
and 
inserting 
‘‘414(c)’’. 
(2) Section 704(a)(1) (21 U.S.C. 374(a)(1)) is 
amended 
by 
striking 
‘‘414(d)’’ 
and 
inserting 
‘‘414(e)’’. 
SEC. 102. REGISTRATION OF FOOD FACILITIES. 
(a) UPDATING OF FOOD CATEGORY REGULATIONS; 
BIENNIAL REGISTRATION RENEWAL.—Section 415(a) (21 
U.S.C. 350d(a)) is amended— 
(1) in paragraph (2), by— 
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(A) striking ‘‘conducts business and’’ and 
inserting ‘‘conducts business, the e-mail address 
for the contact person of the facility, and’’; and 
(B) inserting ‘‘, or any other food cat-
egories as determined appropriate by the Sec-
retary, including by guidance)’’ after ‘‘Code of 
Federal Regulations’’; 
(2) by redesignating paragraphs (3) and (4) as 
paragraphs (4) and (5), respectively; and 
(3) by inserting after paragraph (2) the fol-
lowing: 
‘‘(3) BIENNIAL
REGISTRATION
RENEWAL.— 
During the period beginning on October 1 and end-
ing on December 31 of each even-numbered year, a 
registrant that has submitted a registration under 
paragraph (1) shall submit to the Secretary a re-
newal registration containing the information de-
scribed in paragraph (2). The Secretary shall pro-
vide for an abbreviated registration renewal process 
for any registrant that has not had any changes to 
such information since the registrant submitted the 
preceding registration or registration renewal for the 
facility involved.’’. 
(b) SUSPENSION OF REGISTRATION.— 
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(1) IN
GENERAL.—Section 415 (21 U.S.C. 
350d) is amended— 
(A) in subsection (a)(2), by inserting after 
the first sentence the following: ‘‘The registra-
tion shall contain a consent to permit the Sec-
retary to inspect such facility.’’; 
(B) by redesignating subsections (b) and 
(c) as subsections (c) and (d), respectively; and 
(C) by inserting after subsection (a) the 
following: 
‘‘(b) SUSPENSION OF REGISTRATION.— 
‘‘(1) IN GENERAL.—If the Secretary determines 
that food manufactured, processed, packed, or held 
by a facility registered under this section has a rea-
sonable probability of causing serious adverse health 
consequences or death to humans or animals, the 
Secretary may by order suspend the registration of 
the facility under this section in accordance with this 
subsection. 
‘‘(2) HEARING ON SUSPENSION.—The Secretary 
shall provide the registrant subject to an order 
under paragraph (1) with an opportunity for an in-
formal hearing, to be held as soon as possible but 
not later than 2 days after the issuance of the order, 
on the actions required for reinstatement of registra-
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tion and why the registration that is subject to sus-
pension should be reinstated. The Secretary shall re-
instate a registration if the Secretary determines, 
based on evidence presented, that adequate grounds 
do not exist to continue the suspension of the reg-
istration. 
‘‘(3) POST-HEARING CORRECTIVE ACTION PLAN; 
VACATING OF ORDER.— 
‘‘(A) CORRECTIVE ACTION PLAN.—If, after 
providing opportunity for an informal hearing 
under paragraph (2), the Secretary determines 
that the suspension of registration remains nec-
essary, the Secretary shall require the reg-
istrant to submit a corrective action plan to 
demonstrate how the registrant plans to correct 
the conditions found by the Secretary. The Sec-
retary shall review such plan in a timely man-
ner. 
‘‘(B) VACATING OF ORDER.—Upon a de-
termination by the Secretary that adequate 
grounds do not exist to continue the suspension 
actions required by the order, or that such ac-
tions should be modified, the Secretary shall va-
cate the order or modify the order. 
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‘‘(4) EFFECT OF SUSPENSION.—If the registra-
tion of a facility is suspended under this subsection, 
such facility shall not import food or offer to import 
food into the United States, or otherwise introduce 
food into interstate commerce in the United States. 
‘‘(5) REGULATIONS.—The Secretary shall pro-
mulgate regulations that describe the standards offi-
cials will use in making a determination to suspend 
a registration, and the format such officials will use 
to explain to the registrant the conditions found at 
the facility. 
‘‘(6) NO
DELEGATION.—The authority con-
ferred by this subsection to issue an order to sus-
pend a registration or vacate an order of suspension 
shall not be delegated to any officer or employee 
other than the Commissioner.’’. 
(2) 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) CONFORMING AMENDMENTS.— 
(1) Section 301(d) (21 U.S.C. 331(d)) is 
amended by inserting ‘‘415,’’ after ‘‘404,’’. 
(2) Section 415(d), as redesignated by sub-
section (b), is amended by adding at the end before 
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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. MANDATORY RECALL AUTHORITY. 
(a) IN GENERAL.—Chapter IV (21 U.S.C. 341 et 
seq.) is amended by adding at the end the following: 
‘‘SEC. 418. MANDATORY RECALL AUTHORITY. 
‘‘(a) VOLUNTARY PROCEDURES.—If the Secretary 
determines, based on information gathered through the re-
portable food registry under section 417 or through any 
other means, that there is a reasonable probability that 
an article of food (other than infant formula) is adulter-
ated under section 402 or misbranded under section 
403(w) and the use of or exposure to such article will 
cause serious adverse health consequences or death to hu-
mans or animals, the Secretary shall provide the respon-
sible party (as defined in section 417) with an opportunity 
to cease distribution and recall such article. 
‘‘(b) PREHEARING ORDER TO CEASE DISTRIBUTION 
AND GIVE NOTICE.—If the responsible party refuses to 
or does not voluntarily cease distribution or recall such 
article within the time and in the manner prescribed by 
the Secretary (if so prescribed), the Secretary may, by 
order require, as the Secretary deems necessary, such per-
son to— 
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‘‘(B) specify a timetable in which the recall 
shall occur; 
‘‘(C) require periodic reports to the Sec-
retary describing the progress of the recall; and 
‘‘(D) provide notice to consumers to whom 
such article was, or may have been, distributed. 
‘‘(2) VACATING OF ORDER.—If, after such hear-
ing, the Secretary determines that adequate grounds 
do not exist to continue the actions required by the 
order, or that such actions should be modified, the 
Secretary shall vacate the order or modify the order. 
‘‘(e) COOPERATION AND CONSULTATION.—The Sec-
retary shall work with State and local public health offi-
cials in carrying out this section, as appropriate. 
‘‘(f) PUBLIC NOTIFICATION.—In conducting a recall 
under this section, the Secretary shall ensure that a press 
release is published regarding the recall, as well as alerts 
and public notices, as appropriate, in order to provide noti-
fication of the recall to consumers and retailers to whom 
such article was, or may have been, distributed. The notifi-
cation shall include, at a minimum— 
‘‘(1) the name of the article of food subject to 
the recall; and 
‘‘(2) a description of the risk associated with 
such article. 
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‘‘(g) NO DELEGATION.—The authority conferred by 
this section to order a recall or vacate a recall order shall 
not be delegated to any officer or employee other than the 
Commissioner. 
‘‘(h) EFFECT.—Nothing in this section shall affect 
the authority of the Secretary to request or participate 
in a voluntary recall.’’. 
(b) PROHIBITED ACTS.—Section 301 (21 U.S.C. 331 
et seq.) is amended by adding at the end the following: 
‘‘(oo) The refusal or failure to follow an order under 
section 418.’’. 
SEC. 104. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE 
CONTROLS. 
(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. HAZARD ANALYSIS AND RISK-BASED PREVEN-
TIVE CONTROLS. 
‘‘(a) IN GENERAL.—Each owner, operator, or agent 
in charge of a facility shall, in accordance with this sec-
tion, evaluate the hazards that could affect food manufac-
tured, processed, packed, or held by such facility, identify 
and implement preventive controls to significantly mini-
mize or prevent their occurrence and provide assurances 
that such food is not adulterated under section 402 or 
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misbranded under section 403(w), monitor the perform-
ance of those controls, and maintain records of this moni-
toring as a matter of routine practice. 
‘‘(b) HAZARD ANALYSIS.—The owner, operator, or 
agent in charge of a facility shall— 
‘‘(1) identify and evaluate known or reasonably 
foreseeable hazards that may be associated with the 
facility, including— 
‘‘(A) biological, chemical, physical, and ra-
diological hazards, natural toxins, pesticides, 
drug residues, decomposition, parasites, aller-
gens, and unapproved food and color additives; 
and 
‘‘(B) hazards that occur naturally, may be 
unintentionally introduced, or may be inten-
tionally introduced, including by acts of ter-
rorism; and 
‘‘(2) develop a written analysis of the hazards. 
‘‘(c) PREVENTIVE CONTROLS.—The owner, operator, 
or agent in charge of a facility shall identify and imple-
ment preventive controls, including at critical control 
points, if any, to provide assurances that— 
‘‘(1) hazards identified in the hazard analysis 
conducted under subsection (b) will be significantly 
minimized or prevented; and 
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‘‘(2) 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 
that a facility will implement if the preventive controls im-
plemented under subsection (c) are found to be ineffective 
through monitoring under subsection (d). 
‘‘(f) VERIFICATION.—The owner, operator, or agent 
in charge of a facility shall verify that— 
‘‘(1) the preventive controls implemented under 
subsection (c) are adequate to control the hazards 
identified under subsection (b); 
‘‘(2) the owner, operator, or agent is conducting 
monitoring in accordance with subsection (d); 
‘‘(3) the owner, operator, or agent is making 
appropriate decisions about corrective actions taken 
under subsection (e); and 
‘‘(4) there is documented, periodic reanalysis of 
the plan under subsection (i) to ensure that the plan 
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is still relevant to the raw materials, as well as to 
conditions and processes in the facility, and to new 
and emerging threats. 
‘‘(g) RECORDKEEPING.—The owner, operator, or 
agent in charge of a facility shall maintain, for not less 
than 2 years, records documenting the monitoring of the 
preventive controls implemented under subsection (c), in-
stances of nonconformance material to food safety, in-
stances when corrective actions were implemented, and the 
efficacy of preventive controls and corrective actions. 
‘‘(h) WRITTEN PLAN AND DOCUMENTATION.—Each 
owner, operator, or agent in charge of a facility shall pre-
pare a written plan that documents and describes the pro-
cedures used by the facility to comply with the require-
ments of this section, including analyzing the hazards 
under subsection (b) and identifying the preventive con-
trols adopted to address those hazards under subsection 
(c). High-risk facilities, as determined by the Secretary, 
shall submit such written plan to the Food and Drug Ad-
ministration’s Center for Food Safety and Applied Nutri-
tion. The Secretary or a duly authorized representative of 
the Secretary may review the plan and may make rec-
ommendations regarding the effectiveness of the plan in 
preventing or minimizing the threat of serious adverse 
health consequences or death to humans or animals. All 
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facilities shall promptly make available such written plan, 
together with documentation that the plan is being imple-
mented, to a duly authorized representative of the Sec-
retary upon oral or written request. 
‘‘(i) REQUIREMENT TO REANALYZE.—Each owner, 
operator, or agent in charge of a facility shall conduct a 
reanalysis under subsection (b) whenever a significant 
change is made in the activities conducted at a facility 
operated by such owner, operator, or agent if the change 
creates a reasonable potential for a new hazard or a sig-
nificant increase in a previously identified hazard or not 
less frequently than once every 3 years, whichever is ear-
lier. Such reanalysis shall be completed and additional pre-
ventive controls needed to address the hazard identified, 
if any, shall be implemented before the change in activities 
at the facility is commenced. Such owner, operator, or 
agent shall revise the written plan required under sub-
section (h) if such a significant change is made or docu-
ment 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. 
‘‘(j) DEEMED COMPLIANCE
OF SEAFOOD, JUICE, 
AND LOW-ACID CANNED FOOD FACILITIES IN COMPLI-
ANCE WITH HACCP.—An owner, operator, or agent in 
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charge of a facility required to comply with 1 of the fol-
lowing standards and regulations with respect to such fa-
cility shall be deemed to be in compliance with this section, 
with respect to such facility: 
‘‘(1) The Seafood Hazard Analysis Critical 
Control Points Program of the Food and Drug Ad-
ministration. 
‘‘(2) The Juice Hazard Analysis Critical Con-
trol Points Program of the Food and Drug Adminis-
tration. 
‘‘(3) The Thermally Processed Low-Acid Foods 
Packaged in Hermetically Sealed Containers stand-
ards of the Food and Drug Administration (or any 
successor standards). 
‘‘(k) EXCEPTION FOR FACILITIES IN COMPLIANCE 
WITH SECTION 420.—This section shall not apply to a 
facility that is subject to section 420. 
‘‘(l) AUTHORITY WITH RESPECT TO CERTAIN FA-
CILITIES.—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 
storage of packaged foods that are not exposed to the envi-
ronment. 
‘‘(m) DEFINITIONS.—For purposes of this section: 
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‘‘(1) CRITICAL
CONTROL
POINT.—The term 
‘critical control point’ means a point, step, or proce-
dure in a food process at which control can be ap-
plied and is essential to prevent or eliminate a food 
safety hazard or reduce it 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 ‘pre-
ventive controls’ means those risk-based, reasonably 
appropriate procedures, practices, and processes that 
a person knowledgeable about the safe manufac-
turing, processing, packing, or holding of food would 
have employed to significantly minimize or prevent 
the hazards identified under the hazard analysis con-
ducted under subsection (a) 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 shall include the following: 
‘‘(A) Sanitation procedures for food con-
tact surfaces and utensils and food-contact sur-
faces of equipment. 
‘‘(B) Supervisor, manager, and employee 
hygiene training. 
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‘‘(C) An environmental monitoring pro-
gram to verify the effectiveness of pathogen 
controls. 
‘‘(D) An allergen control program. 
‘‘(E) A recall contingency plan. 
‘‘(F) 
Good 
Manufacturing 
Practices 
(GMPs). 
‘‘(G) Supplier verification activities.’’. 
(b) REGULATIONS.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this Act as the ‘‘Sec-
retary’’) shall promulgate regulations to establish 
science-based minimum standards for conducting a 
hazard analysis, documenting hazards, implementing 
preventive controls, and documenting the implemen-
tation of the preventive controls under section 419 
of the Federal Food, Drug, and Cosmetic Act (as 
added by subsection (a)). 
(2) CONTENT.—The regulations promulgated 
under paragraph (1) shall provide sufficient flexi-
bility to be applicable in all situations, including in 
the operations of small businesses. 
(3) RULE OF CONSTRUCTION.—Nothing in this 
subsection shall be construed to provide the Sec-
retary with the authority to apply specific tech-
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nologies, practices, or critical controls to an indi-
vidual facility. 
(4) REVIEW.—In promulgating the regulations 
under paragraph (1), the Secretary shall review reg-
ulatory hazard analysis and preventive control pro-
grams in existence on the date of enactment of this 
Act to ensure that the program under such section 
419 is consistent, to the extent practicable, with ap-
plicable internationally recognized standards in exist-
ence on such date. 
(c) GUIDANCE DOCUMENT.—The Secretary shall 
issue a guidance document related to hazard analysis and 
preventive controls required under section 419 of the Fed-
eral Food, Drug, and Cosmetic Act (as added by sub-
section (a)). 
(d) PROHIBITED ACTS.—Section 301 (21 U.S.C. 
331), as amended by section 103, is amended by adding 
at the end the following: 
‘‘(pp) The operation of a facility that manufacturers, 
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 419.’’. 
(e) NO EFFECT ON HACCP AUTHORITIES.—Noth-
ing in the amendments made by this section limits the au-
thority of the Secretary under the Federal Food, Drug, 
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SEC. 107. TARGETING OF INSPECTION RESOURCES FOR DO-
MESTIC FACILITIES, FOREIGN FACILITIES, 
AND PORTS OF ENTRY; ANNUAL REPORT. 
(a) TARGETING
OF INSPECTION RESOURCES
FOR 
DOMESTIC FACILITIES, FOREIGN FACILITIES, AND PORTS 
OF ENTRY.—Chapter IV (21 U.S.C. 341 et seq.), as 
amended by section 106, is amended by adding at the end 
the following: 
‘‘SEC. 421. TARGETING OF INSPECTION RESOURCES FOR 
DOMESTIC FACILITIES, FOREIGN FACILITIES, 
AND PORTS OF ENTRY; ANNUAL REPORT. 
‘‘(a) IDENTIFICATION AND INSPECTION OF FACILI-
TIES.— 
‘‘(1) IDENTIFICATION.—The Secretary shall al-
locate resources to inspect facilities according to the 
risk profile of the facilities, which shall be based on 
the following factors: 
‘‘(A) The risk profile of the food manufac-
tured, processed, packed, or held at the facility. 
‘‘(B) The facility’s history of food recalls, 
outbreaks, and violations of food safety stand-
ards. 
‘‘(C) The rigor of the facility’s hazard 
analysis and risk-based preventive controls. 
‘‘(D) Whether the food manufactured, 
processed, packed, handled, prepared, treated, 
VerDate Nov 24 2008 
01:02 Mar 07, 2009
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