SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Safe Food Enforcement, Assessment, Standards and 
Targeting Act of 2008’’ or as the ‘‘Safe FEAST Act of 
2008’’. 
(b) TABLE OF CONTENTS.—The table of contents of 
this Act is as follows: 
Sec. 1. Short title; table of contents. 
Sec. 2. Findings and purposes. 
Sec. 3. Inspection of records during food-related emergencies. 
Sec. 4. Hazard analysis and risk-based preventive controls. 
Sec. 5. Mandatory foreign supplier safety assurance program. 
Sec. 6. Certification of certain imports by competent authority of exporting 
country. 
Sec. 7. Voluntary qualified importer program. 
Sec. 8. Recognition of qualified laboratories for analyses of imported foods. 
Sec. 9. Standards for the safety of fruits and vegetables. 
Sec. 10. Targeting of inspection resources for domestic facilities and points of 
entry. 
Sec. 11. Recognition of third party certification programs. 
Sec. 12. Fees relating to food. 
Sec. 13. Biennial registration renewal. 
Sec. 14. Mandatory recall authority. 
Sec. 15. Building capacity of foreign governments. 
Sec. 16. Domestic capacity building and annual report on food safety programs. 
Sec. 17. Authorization of appropriations. 
SEC. 2. FINDINGS AND PURPOSES. 
(a) FINDINGS.—Congress finds that— 
(1) American consumers have a vital interest in 
a safe, affordable, and wholesome food supply; 
(2) maintenance of a safe food supply requires 
scientifically based food safety standards; 
(3) food production and distribution is increas-
ingly global; 
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(4) ensuring the safety of the food supply, re-
gardless of the source of the food, is a responsibility 
shared by food producers, processors, and retailers 
and by Federal, State, and local agencies; 
(5) assurance of the safety of food is best 
achieved by the adoption of appropriate food produc-
tion and processing practices and procedures; 
(6) enhanced cooperation among regulatory 
agencies worldwide is critical to maintenance of a 
safe food supply; 
(7) food producers, processors, and retailers 
have a vital role in ensuring the safety of the food 
supply; 
(8) food producers, processors, and retailers are 
best situated to ensure the implementation of 
science-based food safety standards worldwide; 
(9) in order to provide appropriate oversight, 
regulatory agencies with responsibility for food safe-
ty must have access to adequate scientific resources, 
modern information technology systems, modern and 
efficient laboratories, and adequate inspectional ca-
pacity; 
(10) ensuring the adequacy of resources for 
regulatory agencies is a public responsibility; and 
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(11) efficient and effective enforcement of food 
safety requirements for imported foods necessitates 
a risk-based systems approach. 
SEC. 3. INSPECTION OF RECORDS DURING FOOD-RELATED 
EMERGENCIES. 
(a) IN GENERAL.—Section 414 of the Federal Food, 
Drug, and Cosmetic Act (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 as such arti-
cle of food under paragraph (1)) at the request of 
an officer or employee duly designated by the Sec-
retary, have permission for such officer or employee, 
upon presentation 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 relat-
ing to such related article that are needed to assist 
the Secretary in determining whether the food pre-
sents a threat of serious adverse health consequences 
or death to humans or animals.’’. 
(b) CONFORMING AMENDMENTS.— 
(1) Section 301(e) of such Act (21 U.S.C. 
331(e)) is amended by striking ‘‘414(b)’’ and insert-
ing ‘‘414(c)’’. 
(2) Section 704(a)(1) of such Act (21 U.S.C. 
374(a)(1)) is amended by striking ‘‘414(d)’’ and in-
serting ‘‘414(e)’’. 
SEC. 4. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE 
CONTROLS. 
(a) IN GENERAL.—Chapter IV of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amend-
ed by adding at the end the following: 
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‘‘SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVEN-
TIVE CONTROLS. 
‘‘(a) IN GENERAL.—Each owner, operator, or agent 
in charge of a facility, as defined in subsection (k)(1), 
shall, in accordance with this section— 
‘‘(1) evaluate the hazards that could affect 
products from such facility; 
‘‘(2) identify and implement risk-based preven-
tive controls to keep such hazards from occurring or 
to significantly minimize their occurrence and pro-
vide reasonable assurances that a product is not 
adulterated; 
‘‘(3) monitor the performance of those controls; 
‘‘(4) maintain records of this monitoring as a 
matter of routine practice; and 
‘‘(5) provide for inspection of the facility at 
such frequency, but not less often than biennially, as 
the Secretary may specify, with an increase in the 
periodicity of such inspections based on facilities 
identified as having an increased risk. 
‘‘(b) HAZARD ANALYSIS.—The owner, operator, or 
agent in charge of a facility shall identify and evaluate 
known or reasonably foreseeable biological, chemical, and 
physical hazards that may be associated with the facility. 
‘‘(c) PREVENTIVE CONTROLS.— 
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‘‘(1) IMPLEMENTATION.—The owner, operator, 
or agent in charge of a facility shall identify and im-
plement reasonably appropriate preventive controls 
so that— 
‘‘(A) risks identified in the hazard analysis 
conducted under subsection (b) will not affect 
the food manufactured, processed or packed by 
such facility; 
‘‘(B) the food will not be adulterated under 
section 402; and 
‘‘(C) the food will not present a threat of 
serious adverse health consequences or death to 
humans or animals. 
‘‘(2) CONTROLS.—Preventive controls include, 
at a minimum, the following practices that improve 
the safety of the food: 
‘‘(A) Sanitation procedures for food con-
tact surfaces and utensils and food-contact sur-
faces of equipment. 
‘‘(B) Supervisor, manager, and employee 
hygiene training. 
‘‘(C) An environmental monitoring pro-
gram to verify the effectiveness of pathogen 
controls. 
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or agent if the change creates a reasonable potential for 
a new hazard or a significant increase in a previously iden-
tified hazard. Such reanalysis shall take into account any 
new scientific or technological advances and any additional 
preventive controls needed to address the hazard identi-
fied, if any, and shall be implemented before any change 
in activities at the facility is commenced. Such owner, op-
erator, or agent shall revise the written plan required 
under subsection (g) if such a significant change is made 
or document the basis for the conclusion that no additional 
or revised preventive controls are needed. 
‘‘(i) EXCEPTION FOR FOOD FACILITIES IN COMPLI-
ANCE WITH APPLICABLE HACCP OR OTHER REGU-
LATORY STANDARDS.—This section shall not apply to an 
owner, operator, or agent in charge of a facility that proc-
esses a food if such facility is subject to the standards 
for a Hazard Analysis Critical Control Points Program or 
other regulatory program of the Food and Drug Adminis-
tration relating to that food. 
‘‘(j) EXCEPTION FOR FACILITIES IN COMPLIANCE 
WITH SECTION 419.—This section shall not apply to an 
owner, operator, or agent in charge of a facility that is 
subject to section 419. 
‘‘(k) DEFINITIONS.—For purposes of this section: 
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‘‘(1) FACILITY.—The term ‘facility’ means a 
domestic or a foreign facility that is required to reg-
ister under section 415, but does include a ware-
house that— 
‘‘(A) holds food packaged for sale to con-
sumers or packed in cases for commercial dis-
tribution; and 
‘‘(B) does not process food or otherwise ex-
pose food to the environment in a way as to 
dramatically increase the likelihood for contami-
nation, not including processing incidental to 
the handling of fruits and vegetables that may 
be held in the warehouse and regulated under 
section 419. 
‘‘(2) 
REASONABLY
APPROPRIATE
SCIENCE- 
BASED PREVENTIVE CONTROLS.—The term ‘reason-
ably appropriate science-based preventive controls’ 
means those procedures, practices, and processes 
that a person knowledgeable about the processing 
and packing of food and science-based food safety 
practices would have employed to address the haz-
ards identified during the hazard analysis under 
subsection (b) at the time of such analysis. Such 
term does not include those controls that result in 
a food that is not commercially viable.’’. 
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(b) GUIDANCE DOCUMENT.—Not later than 1 year 
after the date of enactment of this Act, the Secretary shall 
issue a guidance document related to the preparation of 
a hazard analysis and preventive control plan required 
under section 418 of the Federal Food, Drug, and Cos-
metic Act, as added by subsection (a). 
(c) REGULATIONS.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services shall promulgate regulations to es-
tablish minimum standards for the effective imple-
mentation of section 418 of the Federal Food, Drug, 
and Cosmetic Act, as added by subsection (a). 
(2) CONTENT.—The regulations promulgated 
under paragraph (1) shall— 
(A) be consistent with the principles con-
tained in internationally recognized hazard 
analysis and preventive control standards; and 
(B) provide sufficient flexibility to be appli-
cable in all situations, including in the oper-
ations of small businesses. 
(3) 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 
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418 is consistent with applicable internationally rec-
ognized standards in existence on such date. 
(d) PROHIBITED ACTS.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend-
ed by adding at the end the following: 
‘‘(oo) The operation of a facility that processes or 
packs food for sale in the United States if the person who 
operates such facility has not conducted the hazard anal-
ysis required under section 418(b), implemented reason-
ably appropriate science-based preventive controls under 
section 418(c) in accordance with 418(g), failed to conduct 
a reanalysis as required under section 418(h), or failed 
to have a plan documenting compliance with section 418.’’. 
(e) EFFECTIVE DATE.— 
(1) GENERAL RULE.—The amendments made 
by this section shall take effect 1 year after the date 
of enactment of this Act. 
(2) EXCEPTIONS.—Notwithstanding paragraph 
(1)— 
(A) the amendments made by this section 
shall apply to a small business (as defined in 
the small business size regulations of the Small 
Business Administration, as specified in part 
121 of title 13, Code of Federal Regulations) 
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after the date that is 2 years after the date of 
enactment of this Act; and 
(B) the amendments made by this section 
shall apply to a very small business (as defined 
in such regulations) after the date that is 3 
years after the date of enactment of this Act. 
SEC. 5. MANDATORY FOREIGN SUPPLIER SAFETY ASSUR-
ANCE PROGRAM. 
(a) IN GENERAL.—Chapter VIII of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.) 
is amended by adding at the end the following: 
‘‘SEC. 805. MANDATORY FOREIGN SUPPLIER SAFETY AS-
SURANCE PROGRAM. 
‘‘(a) FOREIGN SUPPLIER SAFETY ASSURANCE PRO-
GRAM.— 
‘‘(1) IN
GENERAL.—Each U.S. importer of 
record shall adopt and document a foreign supplier 
safety assurance program to assure that food im-
ported into the United States— 
‘‘(A) is in compliance with the require-
ments of section 418; 
‘‘(B) is not adulterated under section 402; 
and 
‘‘(C) does not pose a threat of serious ad-
verse health consequences or death. 
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‘‘(2) TREATMENT OF CERTAIN CUSTOMS BRO-
KERS.—For purposes of this section, an ‘importer of 
record’ shall not include a person holding a valid li-
cense under section 1641 of title 19, United States 
Code (commonly referred to as a ‘customs broker’), 
if the customs broker has executed a written agree-
ment with another person who has agreed to comply 
with the requirements of this section with regard to 
food imported or offered for import by the customs 
broker. 
‘‘(b) REQUIREMENTS.— 
‘‘(1) IN GENERAL.—A foreign supplier safety 
assurance program shall include such risk-based 
processes and procedures as the U.S. importer of 
record determines to be necessary and appropriate 
to reasonably ensure that food imported into the 
United States by the importer of record complies 
with U.S. food safety requirements in accordance 
with section 418 and is not adulterated within the 
meaning of section 402. 
‘‘(2) COMPONENTS
OF
A
FOREIGN
SUPPLIER 
SAFETY
ASSURANCE
PROGRAM.—In establishing a 
foreign supplier safety assurance program, a U.S. 
importer of record shall verify, with respect to each 
foreign supplier from which it obtains food, that the 
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foreign supplier has an effective safety assurance 
program. Such verification may include certification 
by a recognized third party certification program 
(under section 421), but such certification from the 
approved third party certification program shall not 
serve as the sole means that may be accepted by the 
Secretary of verification of adherence to a foreign 
supplier safety assurance program. An effective safe-
ty assurance program shall include, at a minimum, 
an evaluation of hazards in accordance with section 
418 and the implementation of reasonable and ap-
propriate preventive controls. 
‘‘(c) GUIDANCE.—Within 270 days of the date of the 
enactment of this section, the Secretary shall issue guid-
ance to assist U.S. importers of record in developing for-
eign supplier safety assurance programs. 
‘‘(d) RECORD ACCESS.—Records of a U.S. importer 
of record related to a foreign supplier safety assurance 
program shall, for a period of not less than 2 years, be 
made available promptly to the Secretary upon written or 
oral request.’’. 
(b) PROHIBITED ACTS.—Section 301 of such Act (21 
U.S.C. 331), as amended by section 4(d), is further 
amended by adding at the end the following: 
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‘‘(pp) The importation or offering for importation of 
a food if the importer of record does not have in place 
a foreign supplier safety assurance program in compliance 
with section 805.’’. 
(c) IMPORTS.—Section 801(a) of such Act (21 U.S.C. 
381(a)) is amended by inserting ‘‘or section 805’’ after 
‘‘or in violation of section 505’’. 
SEC. 6. CERTIFICATION OF CERTAIN IMPORTS BY COM-
PETENT AUTHORITY OF EXPORTING COUN-
TRY. 
(a) IN GENERAL.—Whenever the Secretary of Health 
and Human Services (in this section referred to as the 
‘‘Secretary’’) determines to enter into a memorandum of 
understanding or equivalent agreement with the regu-
latory authorities of another country with responsibility 
for food safety, the Secretary shall include in such memo-
randum of understanding or equivalent agreement a provi-
sion to provide for the certification of certain foods offered 
for import into the United States by a competent regu-
latory authority in the country of export. 
(b) CERTIFICATION.—Such certification provision 
shall provide that, upon reasonable notice given by the 
Secretary, and as a condition of permitting the importa-
tion of food from a specific foreign country or from a spe-
cific facility within a foreign country, a competent regu-
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latory authority in the exporting country agrees to certify 
that each specific shipment of food or food from a specific 
facility offered for importation into the United States has 
been produced, packaged, and held under conditions that 
meet United States food safety standards. Nothing in this 
section shall limit the Secretary’s ability to conduct ran-
dom checks of imported food or to take such other steps 
as the Secretary deems necessary to assure the safety of 
imported food. 
(c) NOTIFICATION AND DETENTION.—Whenever the 
Secretary has entered into a memorandum of agreement 
that includes a certification requirement, the Secretary 
shall notify the Secretary of Homeland Security. The Sec-
retary of Homeland Security shall deny entry to any food 
offered for import for which a certification under this sec-
tion has been required if such certification has not been 
provided in a manner deemed timely and appropriate by 
the Secretary. 
(d) REGISTRY OF CERTIFIED FACILITIES.—The Sec-
retary shall maintain a registry of facilities with respect 
to which certification has been made under this section. 
SEC. 7. VOLUNTARY QUALIFIED IMPORTER PROGRAM. 
Chapter VIII of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 381 et seq.), as amended by section 
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5(a), is further amended by adding at the end the fol-
lowing: 
‘‘SEC. 806. VOLUNTARY QUALIFIED IMPORTER PROGRAM. 
‘‘(a) IN GENERAL.—Beginning not later than 1 year 
after the date of enactment of this section, the Secretary 
shall establish a program, in consultation with the Sec-
retary of Agriculture and Secretary of Homeland Security, 
to provide for the expedited review and importation of food 
products offered for importation by U.S. importers of 
record who have voluntarily agreed to participate in such 
program. In establishing such a program, the Secretary 
shall ensure that the program does not impose redundant 
requirements on persons who participate in existing border 
security programs. In determining eligibility to participate 
in such a program, the Secretary shall consider, among 
other relevant information, the following: 
‘‘(1) Nature and risk-profile of the food or in-
gredient to be imported. 
‘‘(2) Compliance history of the foreign supplier. 
‘‘(3) Capability of the regulatory system of the 
country of export to ensure compliance with United 
States food safety standards, including hazard anal-
ysis and preventive control measures in accordance 
with section 418. 
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801(e)(4)(A) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 381(e)(4)(A)) is amended— 
(A) in the matter preceding clause (i), by 
striking ‘‘a drug,’’ and inserting ‘‘a food, drug’’; 
(B) in clause (i), by striking ‘‘exported 
drug,’’ and inserting ‘‘exported food, drug,’’; 
and 
(C) in clause (ii), by striking ‘‘the drug’’ 
and ‘‘the drug,’’ and inserting ‘‘the food, drug’’ 
and ‘‘the food, drug,’’, respectively. 
(2) TREATMENT OF FEES.—Section 801(c)(4) 
of such Act (21 U.S.C. 381(3)(4)) is amended— 
(A) in subparagraph (B), by striking all 
that follows the first sentence; and 
(B) by adding at the end the following: 
‘‘(C)(i) In the case of fees collected for a fiscal year 
pursuant to this paragraph for certification of exported 
drugs, animal drugs, or devices, the fees shall be credited 
to the appropriation account for salaries and expenses of 
the Food and Drug Administration and be available in ac-
cordance with appropriations Acts until expended, without 
fiscal year limitation. To cover the cost of issuing such 
certifications, such sums as necessary may be transferred 
from such appropriation account for salaries and expenses 
of the Food and Drug Administration without fiscal year 
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