‘‘(4) Compliance of the importer of record with 
the requirements of section 805. 
‘‘(5) Whether the importer of record has been 
certified by a recognized third party certification 
program under section 421. 
‘‘(6) Any other factors the Secretary deems nec-
essary. 
‘‘(b) VOLUNTARY PARTICIPATION.—An importer of 
record may request the Secretary to provide for the expe-
dited review and importation of designated foods in ac-
cordance with the procedures established by the Secretary 
and the Secretary may establish a list of foods for which 
expedited review and importation under this section is au-
thorized. 
‘‘(c) FEE.—A fee is established under section 741 for 
participation of facilities in the program under this sec-
tion.’’. 
SEC. 8. RECOGNITION OF QUALIFIED LABORATORIES FOR 
ANALYSES OF IMPORTED FOODS. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services shall provide for the recognition of lab-
oratories with a demonstrated capability to conduct ana-
lytical testing of food products through programs adminis-
tered by other government agencies, or by qualified non-
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governmental organizations and shall establish a registry 
of laboratories that have been so recognized. 
(b) CRITERIA.—The Secretary of Health and Human 
Services shall require, as a condition of inclusion in the 
registry provided for under subsection (a), that entities 
providing laboratory analyses establish to the satisfaction 
of the agency or organization that is providing the recogni-
tion that— 
(1) appropriate sampling and analytical proce-
dures are followed and reports of analyses are cer-
tified as true and accurate; 
(2) internal quality systems are established and 
maintained; 
(3) procedures exist to evaluate and respond 
promptly to complaints regarding analyses and other 
activities for which the laboratory is recognized; and 
(4) individuals who conduct the analyses are 
qualified by training and experience to do so. 
(c) REVIEW OF RECOGNITION.—Any agency or orga-
nization that maintains a program under which labora-
tories are recognized as qualified to conduct analyses in 
accordance with the criteria set forth in this section shall 
conduct periodic assessments of the qualifications of the 
laboratories that have been recognized by it and shall 
promptly revoke the recognition of any laboratory found 
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not to be in compliance with the agency’s or organization’s 
standards. The agency or organization shall also promptly 
notify the Secretary of Health and Human Services of any 
change in the status of a previously recognized laboratory 
and the Secretary shall promptly revise the registry main-
tained under subsection (a). 
(d) ALTERNATIVE LABORATORIES.—Nothing in this 
section shall prevent a person from using an alternative 
laboratory, such as a university or food company labora-
tory, so long as such person submits— 
(1) to the Secretary evidence to establish the 
qualifications of the laboratory and a reference to 
the validated test method (or methods) used; and 
(2) to the Food and Drug Administration all 
testing results and data. 
SEC. 9. STANDARDS FOR THE SAFETY OF FRUITS AND 
VEGETABLES. 
(a) IN GENERAL.—Chapter IV of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 341 et seq.), as 
amended by section 4(a), is amended by adding at the end 
the following: 
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‘‘SEC. 419. STANDARDS FOR THE SAFETY OF FRUITS AND 
VEGETABLES. 
‘‘(a) DEFINITION.—For purposes of this section, the 
term ‘fruits and vegetables’ shall mean raw agricultural 
products as defined in section 201(r). 
‘‘(b) IN GENERAL.—Not later than 1 year after en-
actment of this section, the Secretary, in consultation with 
the Secretary of Agriculture and representatives of State 
departments of agriculture, shall publish a notice of pro-
posed rulemaking to establish regulations for the safe pro-
duction, harvesting, and packaging of those types of fruits 
and vegetables for which the Secretary has determined 
that such regulations are necessary to minimize the risk 
of serious adverse health consequences. 
‘‘(c) FINAL REGULATION.—Not later than 1 year 
after the close of the comment period on the notice of pro-
posed rulemaking under subsection (a), the Secretary shall 
adopt a final regulation covering those types of fruits and 
vegetables for which the Secretary has determined that 
such regulations are necessary to minimize the risk of seri-
ous adverse health consequences. The final regulation 
shall provide a reasonable period of time for implementa-
tion, taking into account the needs of small businesses for 
additional time to comply. The final regulation shall pro-
vide for coordination of education and enforcement activi-
ties by the Secretary of Agriculture, appropriate State and 
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local agencies, and appropriate agencies of foreign govern-
ments. 
‘‘(d) COOPERATION.—The Secretary shall work with 
State and local public health officials in carrying out this 
section. The Secretary shall coordinate activities with the 
Secretary of Agriculture related to on-farm requirements 
for growers including the development of food safety 
standards and enforcement mechanisms that will address 
regulations adopted under subsection (c). 
‘‘(e) CRITERIA.—The regulations adopted under sub-
section (b) shall— 
‘‘(1) set forth those procedures, processes, and 
practices as the Secretary determines to be reason-
ably necessary to minimize the introduction of 
known or reasonably foreseeable biological, chemical, 
and physical hazards into fruits and vegetables and 
to provide reasonable assurance that the fruits and 
vegetables are not adulterated under section 402; 
‘‘(2) permit States and foreign governments to 
seek variances from the requirements of the regula-
tions, where the State or foreign government deter-
mines that the variance is necessary in light of local 
growing conditions and that the procedures, proc-
esses, and practices to be followed under the vari-
ance are reasonably likely to ensure that the fruits 
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or vegetables are not adulterated within the meaning 
of section 402 to the same extent as the require-
ments of the regulation adopted under subsection 
(b); 
‘‘(3) require that any State or foreign govern-
ment seeking a variance under paragraph (2) shall 
first notify the Secretary of the intended variance 
and the basis for it, and the Secretary may grant 
the variance after 90 days of such notification if 
Secretary does not communicate objections or modi-
fications to the intended variance to the respective 
State or foreign government prior to the conclusion 
of the 90-day period; and 
‘‘(4) provide for publication of notices of re-
quests for variances under paragraph (2) at the time 
they are received. 
‘‘(f) ENFORCEMENT.—The Secretary shall coordinate 
enforcement under this section with appropriate State and 
local agencies and with appropriate agencies of foreign 
governments. In enforcing any standards for the safety of 
fruits and vegetables, the Secretary shall, to the maximum 
extent practicable, use the Department of Agriculture and 
state agricultural agencies. Such enforcement may be in 
the form of audit-based verification systems or other 
methods of inspection. 
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‘‘(g) GUIDANCE FOR GOOD AGRICULTURAL PRAC-
TICES.—Not later than 1 year after the date of the enact-
ment of this section, the Secretary shall publish updated 
guidance, in coordination with the Secretary of Agri-
culture and representatives of State departments of agri-
culture, based on the most currently available scientific 
evidence, for the safe production, harvesting, and pack-
aging of fruits and vegetables. The Secretary shall publish 
subsequently updated guidance, as necessary. 
‘‘(h) SCOPE.—This section shall apply to the produc-
tion, harvesting, and packaging of fruits and vegetables 
intended for human consumption, but not to— 
‘‘(1) activities involving the further processing 
of fruits and vegetables which shall be subject to 
section 418; or 
‘‘(2) those activities that occur in a retail food 
establishment (as such term is defined in regulations 
to carry out section 415(b)(1)).’’. 
(b) PROHIBITED.—Section 301 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 331), as amended by 
sections 4(d) and 5(b), is further amended by adding at 
the end the following: 
‘‘(qq) Production, harvesting, or packaging of fruits 
or vegetables not in accordance with the regulations or a 
variance issued under section 419(d)(2).’’. 
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SEC. 10. TARGETING OF INSPECTION RESOURCES FOR DO-
MESTIC FACILITIES AND POINTS OF ENTRY. 
Chapter IV of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 341 et seq.), as amended by sections 4(a) 
and 9(a), is amended by adding at the end the following: 
‘‘SEC. 420. TARGETING OF INSPECTION RESOURCES FOR 
DOMESTIC 
FACILITIES 
AND 
POINTS 
OF 
ENTRY. 
‘‘(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, handled, prepared, 
treated, distributed, or stored 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 facility has been cer-
tified to conform with United States food safety 
standards by a recognized third party certifi-
cation program under section 421. 
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‘‘(E) Any other criteria deemed necessary 
and appropriate by the Secretary for purposes 
of allocating inspection resources. 
‘‘(2) INSPECTIONS.—The Secretary shall con-
duct inspections of domestic facilities identified 
under paragraph (1) as high-risk facilities not less 
often than once a year. 
‘‘(b) IDENTIFICATION AND INSPECTION OF POINTS 
OF ENTRY.—The Secretary shall inspect shipments of 
food imported into the United States according to the risk 
profile of the food shipment, which shall be based on the 
following factors: 
‘‘(1) The risk profile of the food imported. 
‘‘(2) The risk profile of the origin of the food 
imported. 
‘‘(3) The history of food recalls, outbreaks, and 
violations of food safety standards of the food im-
porter. 
‘‘(4) 
The 
rigor 
of 
the 
foreign 
supplier 
verification of the food importer under section 805. 
‘‘(5) Whether the food importer participates in 
the Voluntary Qualified Importer Program under 
section 806. 
‘‘(6) Whether the facility has been certified to 
conform with United States food safety standards by 
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a recognized third party certification program under 
section 421. 
‘‘(7) Any other criteria deemed necessary and 
appropriate by the Secretary for purposes of allo-
cating inspection resources. 
‘‘(c) FACILITY.—For purposes of this section, the 
term ‘facility’ has the meaning given that term in section 
415.’’. 
SEC. 11. RECOGNITION OF THIRD PARTY CERTIFICATION 
PROGRAMS. 
Chapter IV of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 341 et seq.), as amended by sections 4(a), 
9(a), and 10, is amended by adding at the end the fol-
lowing: 
‘‘SEC. 421. RECOGNITION OF THIRD PARTY CERTIFICATION 
PROGRAMS. 
‘‘(a) IN GENERAL.—Beginning not later than 2 years 
after the date of the enactment of this section, the Sec-
retary shall establish a process under which a third party 
may apply to the Secretary for recognition of a third party 
certification program it operates. 
‘‘(b) RECOGNITION OF PROGRAMS.— 
‘‘(1) IN GENERAL.—The Secretary may not rec-
ognize a third party with respect to its operation of 
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a third party certification program unless the fol-
lowing requirements are met: 
‘‘(A) The third party has demonstrated the 
capacity and competence to operate a third 
party certification program. 
‘‘(B) The processes and standards used by 
the third party in the auditing and certification 
of food processors and producers are sufficient 
to verify compliance of such producers and 
processors with federal food safety standards. 
‘‘(C) The third party must conform to re-
quirements established by the Secretary, includ-
ing periodic reevaluation by the Secretary. In 
establishing such requirements, the Secretary 
shall consider existing standards and proce-
dures established by national and international 
accreditation organizations. 
‘‘(2) APPLICATION OF ACCREDITATION.—In ap-
proving third parties with respect to third party ac-
creditation programs under this section, the Sec-
retary may take into account the accreditation of 
such entities and programs by national and inter-
national accreditation organizations. 
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‘‘(3) REGISTRY.—The Secretary shall maintain 
a registry of recognized third party certification pro-
grams. 
‘‘(c) THIRD PARTY CERTIFICATION PROGRAM DE-
FINED.—In this section: 
‘‘(1) The term ‘third party certification pro-
gram’ means an independent auditing and certifi-
cation program— 
‘‘(A) that evaluates the food safety man-
agement systems and practices of food pro-
ducers and processors using recognized auditing 
standards; and 
‘‘(B) that only certifies such producers or 
processors that it determines are in compliance 
with such standards. 
‘‘(2) The term ‘recognized third party certifi-
cation program’ means a third party certification 
program, and the entity operating which, is recog-
nized under this section. 
‘‘(d) CONSTRUCTION.—Nothing in the section should 
be construed to limit the ability of the Secretary or a des-
ignated agent of the Secretary to conduct random checks 
of imported food or audit facilities as the Secretary deems 
necessary to ensure compliance with federal food safety 
standards. 
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‘‘(e) TERMINATION
OF RECOGNITION.—The Sec-
retary may terminate the recognition of a third party with 
respect to its operation of a third party accreditation pro-
gram under this section— 
‘‘(1) following an investigation and finding by 
the Secretary that the third party or program is no 
longer in compliance with requirements for recogni-
tion under this section; or 
‘‘(2) following the party’s refusal to allow 
United States officials to conduct such audits as 
may be necessary to ensure continued compliance of 
the entity and program with the applicable require-
ments of this section.’’. 
SEC. 12. FEES RELATING TO FOOD. 
(a) IN GENERAL.—Chapter VII of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amend-
ed— 
(1) by redesignating sections 741 and 742 as 
sections 744 and 745, respectively; and 
(2) by adding at the end of subchapter C the 
following: 
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‘‘PART 3—FEES RELATING TO FOOD 
‘‘SEC. 741. AUTHORITY TO COLLECT AND USE REIMBURS-
ABLE FEES FOR VOLUNTARY QUALIFIED IM-
PORTER PROGRAM. 
‘‘(a) FEES FOR VOLUNTARY QUALIFIED IMPORTER 
PROGRAM.—For fiscal year 2009 and each subsequent fis-
cal year, the Secretary shall, in accordance with this sec-
tion, assess and collect fees from each importer required 
to register under section 415 which participates in the vol-
untary qualified importer program under section 806 in 
such year, to reimburse the Food and Drug Administra-
tion for the administrative costs of that importer’s partici-
pation in such program for such year. 
‘‘(b) ESTABLISHMENT OF FEES.— 
‘‘(1) IN GENERAL.—Subject to subsection (c), 
the Secretary shall establish a fee schedule for reim-
bursable expenses to be collected under this section 
for each fiscal year specified in section (a), based on 
the methodology described in paragraph (2). The 
Secretary shall publish such fee schedule for a fiscal 
year in a Federal Register notice not later than 60 
days before the beginning of each fiscal year. 
‘‘(2) FEE
METHODOLOGY
AND
FEE
SCHED-
ULE.— 
‘‘(A) FEE METHODOLOGY.—Fees amounts 
established for collection shall be based on 100 
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percent of the Secretary’s actual costs of the 
activities for each importer participating in the 
voluntary qualified importer program, as de-
scribed in subsection (a), for such fiscal year. 
‘‘(B) FEE
SCHEDULE.—The Secretary 
shall establish in each such fiscal year a fee 
schedule to include all reimbursable expenses, 
including an hourly rate for salaries and ex-
penses for government personnel carrying out of 
such activities, as well as a rate to cover indi-
rect costs necessary for the efficient conduct of 
such activities. The Secretary’s publication of 
the fee schedule under paragraph (1) shall be 
accompanied by a written explanation of the 
methodology for determining each fee on the fee 
schedule. 
‘‘(C) OTHER CONSIDERATIONS.—In estab-
lishing the fee schedule for a fiscal year, the 
Secretary shall also consider the need to ac-
count for any adjustment of fees under para-
graph (3) and such other factors as the Sec-
retary determines appropriate. 
‘‘(3) ADJUSTMENT
OF
FEES.—The Secretary 
may provide for the waiver or reduction of fees 
under this subsection based on financial hardship or 
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other circumstances as determined appropriate by 
the Secretary. 
‘‘(4) 
COMPLIANCE
WITH
INTERNATIONAL 
AGREEMENTS.—Nothing in this section shall be con-
strued to authorize the assessment of any fee incon-
sistent with the agreement establishing the World 
Trade Organization or any other treaty or inter-
national agreement to which the United States is a 
party. 
‘‘(c) CREDITING AND AVAILABILITY OF FEES.—Fees 
collected for each fiscal year under this section shall be 
credited to a fund, hereby established in the Treasury of 
the United States and to be known as the ‘Food and Drug 
Administration Food User Fee Account’, and shall be 
available in accordance with appropriations Acts until ex-
pended, without fiscal year limitation. Such fees shall be 
made available solely to carry out the activities by the Cen-
ter for Food Safety and Applied Nutrition and related ac-
tivities of the Office of Regulatory Affairs related to the 
voluntary qualified importer program. 
‘‘(d) COLLECTION OF FEES.— 
‘‘(1) IN GENERAL.—The Secretary shall specify 
in the Federal Register notice described in sub-
section (b)(1) the time and manner in which fees as-
sessed under this section shall be collected, but in no 
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case shall a facility be required to pay a reimburs-
able fee less than 60 days after the date of receipt 
of a notice from the Secretary assessing such fee. 
‘‘(2) COLLECTION OF UNPAID FEES.—In any 
case where the Secretary does not receive payment 
of a fee assessed under this section within 30 days 
after it is due, such fee shall be treated as a claim 
of the United States Government subject to provi-
sions of subchapter II of chapter 37 of title 31, 
United States Code. 
‘‘(e) ANNUAL REPORT
TO CONGRESS.—Not later 
than 90 days after the end of each fiscal year for which 
fees are assessed under this section, the Secretary shall 
submit a report to the Committee on Health, Education, 
Labor, and Pensions of the United States Senate and the 
Committee on Energy and Commerce of the United States 
House of Representatives, that includes a description of 
fees assessed and collected for each such fiscal year and 
a summary description of the entities paying such fees and 
the types of business in which such entities engage.’’. 
(b) EXPORT CERTIFICATION FEES FOR FOODS AND 
ANIMAL FEED.— 
(1) AUTHORITY FOR EXPORT CERTIFICATIONS 
FOR
FOOD, 
INCLUDING
ANIMAL
FEED.—Section 
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limitation to such appropriation account for salaries and 
expenses with fiscal year limitation. 
‘‘(ii) In the case of fees collected for a fiscal year pur-
suant to this paragraph for the certification of exported 
foods, the fees shall be credited to the Food and Drug 
Administration Food User Fee Account and be available 
in accordance with appropriations Acts until expended, 
without fiscal year limitation.’’. 
(3) CLARIFICATION
OF
CERTIFICATION.—Sec-
tion 801(e)(4) of such Act (21 U.S.C. 381(e)(4)), as 
amended by paragraph (2), is further amended by 
adding at the end the following: 
‘‘(D) For purposes of this paragraph, a certification 
by the Secretary shall be made on such basis, and in such 
form (including a publicly available listing) as the Sec-
retary determines appropriate.’’. 
SEC. 13. BIENNIAL REGISTRATION RENEWAL. 
Section 415(a) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 350d(a)) is amended— 
(1) by redesignating paragraphs (3) and (4) as 
paragraphs (4) and (5), respectively; and 
(2) by inserting after paragraph (2) the fol-
lowing: 
‘‘(3) BIENNIAL REGISTRATION RENEWAL.—On 
a biennial basis, a registrant that has submitted a 
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registration under paragraph (1) shall submit to the 
Secretary a renewal registration containing the in-
formation described in paragraph (2). The Secretary 
may provide 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.’’. 
SEC. 14. MANDATORY RECALL AUTHORITY. 
(a) IN GENERAL.—Section 417 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 350f) is amended by 
adding at the end the following: 
‘‘(l) RECALL OF REPORTABLE FOOD.— 
‘‘(1) VOLUNTARY
PROCEDURES.—If the Sec-
retary determines that there is a reasonable prob-
ability that the use of or exposure to an article of 
food (other than infant formula) will cause serious 
adverse health consequences, the Secretary shall pro-
vide the responsible party that produced or proc-
essed packed or held the reportable food with an op-
portunity to— 
‘‘(A) cease distribution of such article; 
‘‘(B) notify all persons— 
‘‘(i) producing, manufacturing, pack-
ing, processing, preparing, treating, pack-
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aging, distributing, or holding such arti-
cles; or 
‘‘(ii) to which such article has been 
distributed, transported, or sold, to imme-
diately cease distribution of such article; 
‘‘(C) recall such article; 
‘‘(D) provide, in consultation with the Sec-
retary and where deemed necessary, notice to 
consumers to whom such article was, or may 
have been, distributed; and 
‘‘(E) take any combination of the above 
measures, as appropriate in the circumstances. 
The Secretary may not delegate recall authority 
under this subsection to any person other than the 
Commissioner. 
‘‘(2) PRE-HEARING ORDER TO CEASE DISTRIBU-
TION AND GIVE NOTICE.—If the responsible party 
refuses to or does not voluntarily cease distribution, 
make notification, recall such article, or provide no-
tice to consumers as applicable, the Secretary may, 
by order, require, as the Secretary deems necessary, 
such person to— 
‘‘(A) immediately cease distribution of 
such article; 
‘‘(B) immediately notify all persons— 
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‘‘(i) producing, manufacturing, pack-
ing, processing, preparing, treating, pack-
aging, distributing, or holding such arti-
cles; or 
‘‘(ii) to which such article has been 
distributed, transported, or sold, to imme-
diately cease distribution of such article; or 
‘‘(C) immediately take the actions specified 
in both subparagraphs (A) and (B). 
‘‘(3) NOTIFICATION
OF
CONSUMERS
BY
SEC-
RETARY.—The Secretary may, as the Secretary 
deems necessary, provide notice to consumers to 
whom such article was, or may have been, distrib-
uted. 
‘‘(4) HEARING ON ORDER.—The Secretary shall 
provide the responsible party subject to an order 
under paragraph (2) with an opportunity for a hear-
ing, to be held as soon as possible but not later than 
2 days after the date of the issuance of the order, 
on the actions required by the order and on why the 
article that is the subject of the order should not be 
recalled. 
‘‘(5) POST-HEARING RECALL ORDER.— 
‘‘(A) AMENDMENT
OF
ORDER.—If, after 
providing opportunity for a hearing under para-
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graph (4), the Secretary determines that re-
moval of the product is necessary, the Sec-
retary, as the Secretary deems necessary, 
may— 
‘‘(i) amend the order to require recall 
of such article or other appropriate action; 
‘‘(ii) specify a timetable in which the 
recall shall occur; 
‘‘(iii) require periodic reports to the 
Secretary describing the progress of the re-
call; and 
‘‘(iv) provide notice to consumers to 
whom such article was, or may have been, 
distributed. 
‘‘(B) VACATING OF ORDER.—If, after such 
a hearing, the Secretary determines that ade-
quate grounds do not exist to continue the ac-
tions required by the order, the Secretary shall 
vacate or modify the order. 
‘‘(6) FAILURE
TO
COMPLY
WITH
RECALL 
ORDER.—Any person who does not comply with a re-
call order under this subsection shall be liable to a 
fine not to exceed $10,000 for each day of such non-
compliance or to a term of imprisonment not exceed-
ing 6 months, or both. 
VerDate Aug 31 2005 
00:53 Apr 26, 2008
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