1741 
•AMDT. NO. 4805 
‘‘(1) specify how a person shall assess whether 
the person is required to implement mitigation strat-
egies or measures intended to protect against the in-
tentional adulteration of food; and 
‘‘(2) specify appropriate science-based mitiga-
tion strategies or measures to prepare and protect 
the food supply chain at specific vulnerable points, 
as appropriate. 
‘‘(c) 
APPLICABILITY.—Regulations 
promulgated 
under subsection (b) shall apply only to food for which 
there is a high risk of intentional contamination, as deter-
mined by the Secretary, in consultation with the Secretary 
of Homeland Security, under subsection (a), that could 
cause serious adverse health consequences or death to hu-
mans or animals and shall include those foods— 
‘‘(1) for which the Secretary has identified clear 
vulnerabilities (including short shelf-life or suscepti-
bility to intentional contamination at critical control 
points); and 
‘‘(2) in bulk or batch form, prior to being pack-
aged for the final consumer. 
‘‘(d) EXCEPTION.—This section shall not apply to 
farms, except for those that produce milk. 
‘‘(e) DEFINITION.—For purposes of this section, the 
term ‘farm’ has the meaning given that term in section 
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1742 
•AMDT. NO. 4805 
1.227 of title 21, Code of Federal Regulations (or any suc-
cessor regulation).’’. 
(b) GUIDANCE DOCUMENTS.— 
(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of this Act, the Secretary of 
Health and Human Services, in consultation with 
the Secretary of Homeland Security and the Sec-
retary of Agriculture, shall issue guidance docu-
ments related to protection against the intentional 
adulteration of food, including mitigation strategies 
or measures to guard against such adulteration as 
required under section 420 of the Federal Food, 
Drug, and Cosmetic Act, as added by subsection (a). 
(2) CONTENT.—The guidance documents issued 
under paragraph (1) shall— 
(A) include a model assessment for a per-
son to use under subsection (b)(1) of section 
420 of the Federal Food, Drug, and Cosmetic 
Act, as added by subsection (a); 
(B) include examples of mitigation strate-
gies or measures described in subsection (b)(2) 
of such section; and 
(C) specify situations in which the exam-
ples of mitigation strategies or measures de-
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1743 
•AMDT. NO. 4805 
scribed in subsection (b)(2) of such section are 
appropriate. 
(3) LIMITED DISTRIBUTION.—In the interest of 
national security, the Secretary of Health and 
Human Services, in consultation with the Secretary 
of Homeland Security, may determine the time, 
manner, and form in which the guidance documents 
issued under paragraph (1) are made public, includ-
ing by releasing such documents to targeted audi-
ences. 
(c) PERIODIC REVIEW.—The Secretary of Health and 
Human Services shall periodically review and, as appro-
priate, update the regulations under section 420(b) of the 
Federal Food, Drug, and Cosmetic Act, as added by sub-
section (a), and the guidance documents under subsection 
(b). 
(d) PROHIBITED ACTS.—Section 301 (21 U.S.C. 331 
et seq.), as amended by section 6105, is amended by add-
ing at the end the following: 
‘‘(ww) The failure to comply with section 420.’’. 
SEC. 6107. AUTHORITY TO COLLECT FEES. 
(a) FEES FOR REINSPECTION, RECALL, AND IMPOR-
TATION ACTIVITIES.—Subchapter C of chapter VII (21 
U.S.C. 379f et seq.) is amended by adding at the end the 
following: 
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•AMDT. NO. 4805 
‘‘PART 6—FEES RELATED TO FOOD 
‘‘SEC. 743. AUTHORITY TO COLLECT AND USE FEES. 
‘‘(a) IN GENERAL.— 
‘‘(1) PURPOSE
AND
AUTHORITY.—For fiscal 
year 2010 and each subsequent fiscal year, the Sec-
retary shall, in accordance with this section, assess 
and collect fees from— 
‘‘(A) the responsible party for each domes-
tic facility (as defined in section 415(b)) and 
the United States agent for each foreign facility 
subject to a reinspection in such fiscal year, to 
cover reinspection-related costs for such year; 
‘‘(B) the responsible party for a domestic 
facility (as defined in section 415(b)) and an 
importer who does not comply with a recall 
order under section 423 or under section 412(f) 
in such fiscal year, to cover food recall activities 
associated with such order performed by the 
Secretary, including technical assistance, follow- 
up effectiveness checks, and public notifications, 
for such year; 
‘‘(C) each importer participating in the 
voluntary qualified importer program under sec-
tion 806 in such year, to cover the administra-
tive costs of such program for such year; and 
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•AMDT. NO. 4805 
‘‘(D) each importer subject to a reinspec-
tion in such fiscal year, to cover reinspection-re-
lated costs for such year. 
‘‘(2) DEFINITIONS.—For purposes of this sec-
tion— 
‘‘(A) the term ‘reinspection’ means— 
‘‘(i) with respect to domestic facilities 
(as defined in section 415(b)), 1 or more 
inspections conducted under section 704 
subsequent to an inspection conducted 
under such provision which identified non-
compliance materially related to a food 
safety requirement of this Act, specifically 
to determine whether compliance has been 
achieved to the Secretary’s satisfaction; 
and 
‘‘(ii) with respect to importers, 1 or 
more examinations conducted under sec-
tion 801 subsequent to an examination 
conducted under such provision which 
identified noncompliance materially related 
to a food safety requirement of this Act, 
specifically to determine whether compli-
ance has been achieved to the Secretary’s 
satisfaction; 
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•AMDT. NO. 4805 
‘‘(B) the term ‘reinspection-related costs’ 
means all expenses, including administrative ex-
penses, incurred in connection with— 
‘‘(i) arranging, conducting, and evalu-
ating the results of reinspections; and 
‘‘(ii) assessing and collecting reinspec-
tion fees under this section; and 
‘‘(C) the term ‘responsible party’ has the 
meaning given such term in section 417(a)(1). 
‘‘(b) ESTABLISHMENT OF FEES.— 
‘‘(1) IN GENERAL.—Subject to subsections (c) 
and (d), the Secretary shall establish the fees to be 
collected under this section for each fiscal year speci-
fied in subsection (a)(1), based on the methodology 
described under paragraph (2), and shall publish 
such fees in a Federal Register notice not later than 
60 days before the start of each such year. 
‘‘(2) FEE METHODOLOGY.— 
‘‘(A) FEES.—Fees amounts established for 
collection— 
‘‘(i) under subparagraph (A) of sub-
section (a)(1) for a fiscal year shall be 
based on the Secretary’s estimate of 100 
percent of the costs of the reinspection-re-
lated activities (including by type or level 
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1747 
•AMDT. NO. 4805 
of reinspection activity, as the Secretary 
determines applicable) described in such 
subparagraph (A) for such year; 
‘‘(ii) under subparagraph (B) of sub-
section (a)(1) for a fiscal year shall be 
based on the Secretary’s estimate of 100 
percent of the costs of the activities de-
scribed in such subparagraph (B) for such 
year; 
‘‘(iii) under subparagraph (C) of sub-
section (a)(1) for a fiscal year shall be 
based on the Secretary’s estimate of 100 
percent of the costs of the activities de-
scribed in such subparagraph (C) for such 
year; and 
‘‘(iv) under subparagraph (D) of sub-
section (a)(1) for a fiscal year shall be 
based on the Secretary’s estimate of 100 
percent of the costs of the activities de-
scribed in such subparagraph (D) for such 
year. 
‘‘(B) OTHER CONSIDERATIONS.— 
‘‘(i) 
VOLUNTARY
QUALIFIED
IM-
PORTER PROGRAM.—In establishing the fee 
amounts under subparagraph (A)(iii) for a 
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•AMDT. NO. 4805 
fiscal year, the Secretary shall provide for 
the number of importers who have sub-
mitted to the Secretary a notice under sec-
tion 806(c) informing the Secretary of the 
intent of such importer to participate in 
the program under section 806 in such fis-
cal year. 
‘‘(ii) CREDITING OF FEES.—In estab-
lishing the fee amounts under subpara-
graph (A) for a fiscal year, the Secretary 
shall provide for the crediting of fees from 
the previous year to the next year if the 
Secretary overestimated the amount of fees 
needed to carry out such activities, and 
consider the need to account for any ad-
justment of fees and such other factors as 
the Secretary determines appropriate. 
‘‘(iii) PUBLISHED GUIDELINES.—Not 
later than 180 days after the date of en-
actment of the FDA Food Safety Mod-
ernization Act, the Secretary shall publish 
in the Federal Register a proposed set of 
guidelines in consideration of the burden of 
fee amounts on small business. Such con-
sideration 
may 
include 
reduced 
fee 
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1749 
•AMDT. NO. 4805 
amounts for small businesses. The Sec-
retary shall provide for a period of public 
comment on such guidelines. The Secretary 
shall adjust the fee schedule for small busi-
nesses subject to such fees only through 
notice and comment rulemaking. 
‘‘(3) USE OF FEES.—The Secretary shall make 
all of the fees collected pursuant to clause (i), (ii), 
(iii), and (iv) of paragraph (2)(A) available solely to 
pay for the costs referred to in such clause (i), (ii), 
(iii), and (iv) of paragraph (2)(A), respectively. 
‘‘(c) LIMITATIONS.— 
‘‘(1) IN GENERAL.—Fees under subsection (a) 
shall be refunded for a fiscal year beginning after 
fiscal year 2010 unless the amount of the total ap-
propriations for food safety activities at the Food 
and Drug Administration for such fiscal year (ex-
cluding the amount of fees appropriated for such fis-
cal year) is equal to or greater than the amount of 
appropriations for food safety activities at the Food 
and Drug Administration for fiscal year 2009 (ex-
cluding the amount of fees appropriated for such fis-
cal year), multiplied by the adjustment factor under 
paragraph (3). 
‘‘(2) AUTHORITY.—If— 
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•AMDT. NO. 4805 
‘‘(A) the Secretary does not assess fees 
under subsection (a) for a portion of a fiscal 
year because paragraph (1) applies; and 
‘‘(B) at a later date in such fiscal year, 
such paragraph (1) ceases to apply, 
the Secretary may assess and collect such fees under 
subsection (a), without any modification to the rate 
of such fees, notwithstanding the provisions of sub-
section (a) relating to the date fees are to be paid. 
‘‘(3) ADJUSTMENT FACTOR.— 
‘‘(A) IN GENERAL.—The adjustment factor 
described in paragraph (1) shall be the total 
percentage change that occurred in the Con-
sumer Price Index for all urban consumers (all 
items; United States city average) for the 12- 
month period ending June 30 preceding the fis-
cal year, but in no case shall such adjustment 
factor be negative. 
‘‘(B) COMPOUNDED
BASIS.—The adjust-
ment under subparagraph (A) made each fiscal 
year shall be added on a compounded basis to 
the sum of all adjustments made each fiscal 
year after fiscal year 2009. 
‘‘(4) LIMITATION
ON
AMOUNT
OF
CERTAIN 
FEES.— 
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•AMDT. NO. 4805 
(ii) conducting surveillance to prevent 
the spread of diseases. 
(C) EMERGENCY
RESPONSE
GOAL.—En-
sure an efficient response to agriculture and 
food emergencies by— 
(i) immediately investigating animal 
disease outbreaks and suspected food con-
tamination; 
(ii) preventing additional human ill-
nesses; 
(iii) organizing, training, and equip-
ping animal, plant, and food emergency re-
sponse teams of— 
(I) the Federal Government; and 
(II) State, local, and tribal gov-
ernments; 
(iv) designing, developing, and evalu-
ating training and exercises carried out 
under agriculture and food defense plans; 
and 
(v) ensuring consistent and organized 
risk communication to the public by— 
(I) the Federal Government; 
(II) State, local, and tribal gov-
ernments; and 
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