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•AMDT. NO. 4805 
(b) ESTABLISHMENT
OF VOLUNTARY FOOD AL-
LERGY AND ANAPHYLAXIS MANAGEMENT GUIDELINES.— 
(1) ESTABLISHMENT.— 
(A) IN GENERAL.—Not later than 1 year 
after the date of enactment of this Act, the Sec-
retary, in consultation with the Secretary of 
Education, shall— 
(i) develop guidelines to be used on a 
voluntary basis to develop plans for indi-
viduals to manage the risk of food allergy 
and anaphylaxis in schools and early child-
hood education programs; and 
(ii) make such guidelines available to 
local educational agencies, schools, early 
childhood education programs, and other 
interested entities and individuals to be im-
plemented on a voluntary basis only. 
(B) APPLICABILITY OF FERPA.—Each plan 
described in subparagraph (A) that is developed 
for an individual shall be considered an edu-
cation record for the purpose of section 444 of 
the General Education Provisions Act (com-
monly referred to as the ‘‘Family Educational 
Rights and Privacy Act of 1974’’) (20 U.S.C. 
1232g). 
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•AMDT. NO. 4805 
(2) CONTENTS.—The voluntary guidelines de-
veloped by the Secretary under paragraph (1) shall 
address each of the following and may be updated 
as the Secretary determines necessary: 
(A) Parental obligation to provide the 
school or early childhood education program, 
prior to the start of every school year, with— 
(i) documentation from their child’s 
physician or nurse— 
(I) supporting a diagnosis of food 
allergy, and any risk of anaphylaxis, if 
applicable; 
(II) identifying any food to which 
the child is allergic; 
(III) describing, if appropriate, 
any prior history of anaphylaxis; 
(IV) listing any medication pre-
scribed for the child for the treatment 
of anaphylaxis; 
(V) detailing emergency treat-
ment procedures in the event of a re-
action; 
(VI) listing the signs and symp-
toms of a reaction; and 
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•AMDT. NO. 4805 
(VII) assessing the child’s readi-
ness for self-administration of pre-
scription medication; and 
(ii) a list of substitute meals that may 
be offered to the child by school or early 
childhood education program food service 
personnel. 
(B) The creation and maintenance of an 
individual plan for food allergy management, in 
consultation with the parent, tailored to the 
needs of each child with a documented risk for 
anaphylaxis, including any procedures for the 
self-administration of medication by such chil-
dren in instances where— 
(i) the children are capable of self-ad-
ministering medication; and 
(ii) such administration is not prohib-
ited by State law. 
(C) Communication strategies between in-
dividual schools or early childhood education 
programs and providers of emergency medical 
services, including appropriate instructions for 
emergency medical response. 
(D) Strategies to reduce the risk of expo-
sure to anaphylactic causative agents in class-
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•AMDT. NO. 4805 
rooms and common school or early childhood 
education program areas such as cafeterias. 
(E) The dissemination of general informa-
tion on life-threatening food allergies to school 
or early childhood education program staff, par-
ents, and children. 
(F) Food allergy management training of 
school or early childhood education program 
personnel who regularly come into contact with 
children with life-threatening food allergies. 
(G) The authorization and training of 
school or early childhood education program 
personnel to administer epinephrine when the 
nurse is not immediately available. 
(H) The timely accessibility of epinephrine 
by school or early childhood education program 
personnel when the nurse is not immediately 
available. 
(I) The creation of a plan contained in 
each individual plan for food allergy manage-
ment that addresses the appropriate response to 
an incident of anaphylaxis of a child while such 
child is engaged in extracurricular programs of 
a school or early childhood education program, 
such as nonacademic outings and field trips, 
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•AMDT. NO. 4805 
before- and after-school programs or before- 
and after-early child education program pro-
grams, and school-sponsored or early childhood 
education program-sponsored programs held on 
weekends. 
(J) Maintenance of information for each 
administration of epinephrine to a child at risk 
for anaphylaxis and prompt notification to par-
ents. 
(K) Other elements the Secretary deter-
mines necessary for the management of food al-
lergies and anaphylaxis in schools and early 
childhood education programs. 
(3) RELATION TO STATE LAW.—Nothing in this 
section or the guidelines developed by the Secretary 
under paragraph (1) shall be construed to preempt 
State law, including any State law regarding wheth-
er students at risk for anaphylaxis may self-admin-
ister medication. 
(c) SCHOOL-BASED FOOD ALLERGY MANAGEMENT 
GRANTS.— 
(1) IN GENERAL.—The Secretary may award 
grants to local educational agencies to assist such 
agencies with implementing voluntary food allergy 
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•AMDT. NO. 4805 
and anaphylaxis management guidelines described in 
subsection (b). 
(2) APPLICATION.— 
(A) IN GENERAL.—To be eligible to receive 
a grant under this subsection, a local edu-
cational agency shall submit an application to 
the Secretary at such time, in such manner, 
and including such information as the Secretary 
may reasonably require. 
(B) CONTENTS.—Each application sub-
mitted under subparagraph (A) shall include— 
(i) an assurance that the local edu-
cational agency has developed plans in ac-
cordance with the food allergy and anaphy-
laxis management guidelines described in 
subsection (b); 
(ii) a description of the activities to be 
funded by the grant in carrying out the 
food allergy and anaphylaxis management 
guidelines, including— 
(I) how the guidelines will be car-
ried out at individual schools served 
by the local educational agency; 
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•AMDT. NO. 4805 
(II) how the local educational 
agency will inform parents and stu-
dents of the guidelines in place; 
(III) how school nurses, teachers, 
administrators, and other school-based 
staff will be made aware of, and given 
training on, when applicable, the 
guidelines in place; and 
(IV) any other activities that the 
Secretary determines appropriate; 
(iii) an itemization of how grant funds 
received under this subsection will be ex-
pended; 
(iv) a description of how adoption of 
the guidelines and implementation of grant 
activities will be monitored; and 
(v) an agreement by the local edu-
cational agency to report information re-
quired by the Secretary to conduct evalua-
tions under this subsection. 
(3) USE
OF
FUNDS.—Each local educational 
agency that receives a grant under this subsection 
may use the grant funds for the following: 
(A) Purchase of materials and supplies, in-
cluding limited medical supplies such as epi-
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•AMDT. NO. 4805 
nephrine and disposable wet wipes, to support 
carrying out the food allergy and anaphylaxis 
management guidelines described in subsection 
(b). 
(B) In partnership with local health de-
partments, school nurse, teacher, and personnel 
training for food allergy management. 
(C) Programs that educate students as to 
the presence of, and policies and procedures in 
place related to, food allergies and anaphylactic 
shock. 
(D) Outreach to parents. 
(E) Any other activities consistent with the 
guidelines described in subsection (b). 
(4) DURATION
OF
AWARDS.—The Secretary 
may award grants under this subsection for a period 
of not more than 2 years. In the event the Secretary 
conducts a program evaluation under this sub-
section, funding in the second year of the grant, 
where applicable, shall be contingent on a successful 
program evaluation by the Secretary after the first 
year. 
(5) LIMITATION
ON
GRANT
FUNDING.—The 
Secretary may not provide grant funding to a local 
educational agency under this subsection after such 
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•AMDT. NO. 4805 
local educational agency has received 2 years of 
grant funding under this subsection. 
(6) MAXIMUM AMOUNT OF ANNUAL AWARDS.— 
A grant awarded under this subsection may not be 
made in an amount that is more than $50,000 an-
nually. 
(7) PRIORITY.—In awarding grants under this 
subsection, the Secretary shall give priority to local 
educational agencies with the highest percentages of 
children who are counted under section 1124(c) of 
the Elementary and Secondary Education Act of 
1965 (20 U.S.C. 6333(c)). 
(8) MATCHING FUNDS.— 
(A) IN GENERAL.—The Secretary may not 
award a grant under this subsection unless the 
local educational agency agrees that, with re-
spect to the costs to be incurred by such local 
educational agency in carrying out the grant ac-
tivities, the local educational agency shall make 
available (directly or through donations from 
public or private entities) non-Federal funds to-
ward such costs in an amount equal to not less 
than 25 percent of the amount of the grant. 
(B) DETERMINATION OF AMOUNT OF NON- 
FEDERAL CONTRIBUTION.—Non-Federal funds 
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•AMDT. NO. 4805 
required under subparagraph (A) may be cash 
or in kind, including plant, equipment, or serv-
ices. Amounts provided by the Federal Govern-
ment, and any portion of any service subsidized 
by the Federal Government, may not be in-
cluded in determining the amount of such non- 
Federal funds. 
(9) ADMINISTRATIVE
FUNDS.—A local edu-
cational agency that receives a grant under this sub-
section may use not more than 2 percent of the 
grant amount for administrative costs related to car-
rying out this subsection. 
(10) PROGRESS
AND
EVALUATIONS.—At the 
completion of the grant period referred to in para-
graph (4), a local educational agency shall provide 
the Secretary with information on how grant funds 
were spent and the status of implementation of the 
food allergy and anaphylaxis management guidelines 
described in subsection (b). 
(11) SUPPLEMENT, 
NOT
SUPPLANT.—Grant 
funds received under this subsection shall be used to 
supplement, and not supplant, non-Federal funds 
and any other Federal funds available to carry out 
the activities described in this subsection. 
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•AMDT. NO. 4805 
(12) AUTHORIZATION
OF
APPROPRIATIONS.— 
There is authorized to be appropriated to carry out 
this subsection $30,000,000 for fiscal year 2011 and 
such sums as may be necessary for each of the 4 
succeeding fiscal years. 
(d) VOLUNTARY NATURE OF GUIDELINES.— 
(1) IN GENERAL.—The food allergy and ana-
phylaxis management guidelines developed by the 
Secretary under subsection (b) are voluntary. Noth-
ing in this section or the guidelines developed by the 
Secretary under subsection (b) shall be construed to 
require a local educational agency to implement such 
guidelines. 
(2) EXCEPTION.—Notwithstanding paragraph 
(1), the Secretary may enforce an agreement by a 
local educational agency to implement food allergy 
and anaphylaxis management guidelines as a condi-
tion of the receipt of a grant under subsection (c). 
SEC. 6113. NEW DIETARY INGREDIENTS. 
(a) IN GENERAL.—Section 413 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 350b) is amended— 
(1) by redesignating subsection (c) as sub-
section (d); and 
(2) by inserting after subsection (b) the fol-
lowing: 
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•AMDT. NO. 4805 
‘‘(c) NOTIFICATION.— 
‘‘(1) IN GENERAL.—If the Secretary determines 
that the information in a new dietary ingredient no-
tification submitted under this section for an article 
purported to be a new dietary ingredient is inad-
equate to establish that a dietary supplement con-
taining such article will reasonably be expected to be 
safe because the article may be, or may contain, an 
anabolic steroid or an analogue of an anabolic ster-
oid, the Secretary shall notify the Drug Enforcement 
Administration of such determination. Such notifica-
tion by the Secretary shall include, at a minimum, 
the name of the dietary supplement or article, the 
name of the person or persons who marketed the 
product or made the submission of information re-
garding the article to the Secretary under this sec-
tion, and any contact information for such person or 
persons that the Secretary has. 
‘‘(2) DEFINITIONS.—For purposes of this sub-
section— 
‘‘(A) the term ‘anabolic steroid’ has the 
meaning given such term in section 102(41) of 
the Controlled Substances Act; and 
‘‘(B) the term ‘analogue of an anabolic 
steroid’ means a substance whose chemical 
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•AMDT. NO. 4805 
structure is substantially similar to the chem-
ical structure of an anabolic steroid.’’. 
(b) GUIDANCE.—Not later than 180 days after the 
date of enactment of this Act, the Secretary shall publish 
guidance that clarifies when a dietary supplement ingre-
dient is a new dietary ingredient, when the manufacturer 
or distributor of a dietary ingredient or dietary supple-
ment should provide the Secretary with information as de-
scribed in section 413(a)(2) of the Federal Food, Drug, 
and Cosmetic Act, the evidence needed to document the 
safety of new dietary ingredients, and appropriate meth-
ods for establishing the identify of a new dietary ingre-
dient. 
SEC. 6114. REQUIREMENT FOR GUIDANCE RELATING TO 
POST-HARVEST PROCESSING OF RAW OYS-
TERS. 
(a) IN GENERAL.—Not later than 90 days prior to 
the issuance of any guidance, regulation, or suggested 
amendment by the Food and Drug Administration to the 
National Shellfish Sanitation Program’s Model Ordinance, 
or the issuance of any guidance or regulation by the Food 
and Drug Administration relating to the Seafood Hazard 
Analysis Critical Control Points Program of the Food and 
Drug Administration (parts 123 and 1240 of title 21, 
Code of Federal Regulations (or any successor regula-
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•AMDT. NO. 4805 
tions), where such guidance, regulation, or suggested 
amendment relates to post-harvest processing for raw oys-
ters, the Secretary shall prepare and submit to the Com-
mittee on Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Commerce of 
the House of Representatives a report which shall in-
clude— 
(1) an assessment of how post-harvest proc-
essing or other equivalent controls feasibly may be 
implemented in the fastest, safest, and most eco-
nomical manner; 
(2) the projected public health benefits of any 
proposed post-harvest processing; 
(3) the projected costs of compliance with such 
post-harvest processing measures; 
(4) the impact post-harvest processing is ex-
pected to have on the sales, cost, and availability of 
raw oysters; 
(5) criteria for ensuring post-harvest processing 
standards will be applied equally to shellfish im-
ported from all nations of origin; 
(6) an evaluation of alternative measures to 
prevent, eliminate, or reduce to an acceptable level 
the occurrence of foodborne illness; and 
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•AMDT. NO. 4805 
(7) the extent to which the Food and Drug Ad-
ministration has consulted with the States and other 
regulatory agencies, as appropriate, with regard to 
post-harvest processing measures. 
(b) LIMITATION.—Subsection (a) shall not apply to 
the guidance described in section 6103(h). 
(c) REVIEW AND EVALUATION.—Not later than 30 
days after the Secretary issues a proposed regulation or 
guidance described in subsection (a), the Comptroller Gen-
eral of the United States shall— 
(1) review and evaluate the report described in 
subsection (a) and report to Congress on the find-
ings of the estimates and analysis in the report; 
(2) compare such proposed regulation or guid-
ance to similar regulations or guidance with respect 
to other regulated foods, including a comparison of 
risks the Secretary may find associated with seafood 
and the instances of those risks in such other regu-
lated foods; and 
(3) evaluate the impact of post-harvest proc-
essing on the competitiveness of the domestic oyster 
industry in the United States and in international 
markets. 
(d) WAIVER.—The requirement of preparing a report 
under subsection (a) shall be waived if the Secretary issues 
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•AMDT. NO. 4805 
a guidance that is adopted as a consensus agreement be-
tween Federal and State regulators and the oyster indus-
try, acting through the Interstate Shellfish Sanitation 
Conference. 
(e) PUBLIC ACCESS.—Any report prepared under 
this section shall be made available to the public. 
SEC. 6115. PORT SHOPPING. 
Until the date on which the Secretary promulgates 
a final rule that implements the amendments made by sec-
tion 308 of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (Public Law 
107–188), the Secretary shall notify the Secretary of 
Homeland Security of all instances in which the Secretary 
refuses to admit a food into the United States under sec-
tion 801(a) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 381(a)) so that the Secretary of Homeland Se-
curity, acting through the Commissioner of Customs and 
Border Protection, may prevent food refused admittance 
into the United States by a United States port of entry 
from being admitted by another United States port of 
entry, through the notification of other such United States 
ports of entry. 
SEC. 6116. ALCOHOL-RELATED FACILITIES. 
(a) IN GENERAL.—Except as provided by sections 
6102, 6206, 6207, 6302, 6304, 6402, 6403, and 6404 of 
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•AMDT. NO. 4805 
this Act, and the amendments made by such sections, 
nothing in this Act, or the amendments made by this Act, 
shall be construed to apply to a facility that— 
(1) under the Federal Alcohol Administration 
Act (27 U.S.C. 201 et seq.) or chapter 51 of subtitle 
E of the Internal Revenue Code of 1986 (26 U.S.C. 
5001 et seq.) is required to obtain a permit or to 
register with the Secretary of the Treasury as a con-
dition of doing business in the United States; and 
(2) under section 415 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 350d) is re-
quired to register as a facility because such facility 
is engaged in manufacturing, processing, packing, or 
holding 1 or more alcoholic beverages, with respect 
to the activities of such facility that relate to the 
manufacturing, processing, packing, or holding of al-
coholic beverages. 
(b) LIMITED RECEIPT AND DISTRIBUTION OF NON-
ALCOHOL FOOD.—Subsection (a) shall not apply to a fa-
cility engaged in the receipt and distribution of any non-
alcohol food, except that such paragraph shall apply to a 
facility described in such paragraph that receives and dis-
tributes nonalcohol food, provided such food is received 
and distributed— 
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•AMDT. NO. 4805 
(1) in a prepackaged form that prevents any di-
rect human contact with such food; and 
(2) in amounts that constitute not more than 5 
percent of the overall sales of such facility, as deter-
mined by the Secretary of the Treasury. 
(c) RULE OF CONSTRUCTION.—Except as provided in 
subsections (a) and (b), this section shall not be construed 
to exempt any food, other than alcoholic beverages, as de-
fined in section 214 of the Federal Alcohol Administration 
Act (27 U.S.C. 214), from the requirements of this Act 
(including the amendments made by this Act). 
TITLE II—IMPROVING CAPACITY 
TO DETECT AND RESPOND TO 
FOOD SAFETY PROBLEMS 
SEC. 6201. TARGETING OF INSPECTION RESOURCES FOR 
DOMESTIC 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 6106, is amended by adding at the 
end the following: 
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•AMDT. NO. 4805 
‘‘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 
identify high-risk facilities and shall allocate re-
sources to inspect facilities according to the known 
safety risks of the facilities, which shall be based on 
the following factors: 
‘‘(A) The known safety risks of the food 
manufactured, processed, packed, or held at the 
facility. 
‘‘(B) The compliance history of a facility, 
including with regard to food recalls, outbreaks 
of foodborne illness, and violations of food safe-
ty standards. 
‘‘(C) The rigor and effectiveness of the fa-
cility’s hazard analysis and risk-based preven-
tive controls. 
‘‘(D) Whether the food manufactured, 
processed, packed, or held at the facility meets 
the criteria for priority under section 801(h)(1). 
‘‘(E) Whether the food or the facility that 
manufactured, processed, packed, or held such 
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•AMDT. NO. 4805 
food has received a certification as described in 
section 801(q) or 806, as appropriate. 
‘‘(F) Any other criteria deemed necessary 
and appropriate by the Secretary for purposes 
of allocating inspection resources. 
‘‘(2) INSPECTIONS.— 
‘‘(A) IN GENERAL.—Beginning on the date 
of enactment of the FDA Food Safety Mod-
ernization Act, the Secretary shall increase the 
frequency of inspection of all facilities. 
‘‘(B) DOMESTIC HIGH-RISK FACILITIES.— 
The Secretary shall increase the frequency of 
inspection of domestic facilities identified under 
paragraph (1) as high-risk facilities such that 
each such facility is inspected— 
‘‘(i) not less often than once in the 5- 
year period following the date of enactment 
of the FDA Food Safety Modernization 
Act; and 
‘‘(ii) not less often than once every 3 
years thereafter. 
‘‘(C) DOMESTIC
NON-HIGH-RISK
FACILI-
TIES.—The Secretary shall ensure that each do-
mestic facility that is not identified under para-
graph (1) as a high-risk facility is inspected— 
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•AMDT. NO. 4805 
‘‘(i) not less often than once in the 7- 
year period following the date of enactment 
of the FDA Food Safety Modernization 
Act; and 
‘‘(ii) not less often than once every 5 
years thereafter. 
‘‘(D) FOREIGN FACILITIES.— 
‘‘(i) YEAR
1.—In the 1-year period 
following the date of enactment of the 
FDA Food Safety Modernization Act, the 
Secretary shall inspect not fewer than 600 
foreign facilities. 
‘‘(ii) SUBSEQUENT
YEARS.—In each 
of the 5 years following the 1-year period 
described in clause (i), the Secretary shall 
inspect not fewer than twice the number of 
foreign facilities inspected by the Secretary 
during the previous year. 
‘‘(E) RELIANCE ON FEDERAL, STATE, OR 
LOCAL INSPECTIONS.—In meeting the inspec-
tion requirements under this subsection for do-
mestic facilities, the Secretary may rely on in-
spections conducted by other Federal, State, or 
local agencies under interagency agreements, 
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•AMDT. NO. 4805 
contracts, memoranda of understanding, or 
other obligations. 
‘‘(b) IDENTIFICATION AND INSPECTION AT PORTS OF 
ENTRY.—The Secretary, in consultation with the Sec-
retary of Homeland Security, shall allocate resources to 
inspect any article of food imported into the United States 
according to the known safety risks of the article of food, 
which shall be based on the following factors: 
‘‘(1) The known safety risks of the food im-
ported. 
‘‘(2) The known safety risks of the countries or 
regions of origin and countries through which such 
article of food is transported. 
‘‘(3) The compliance history of the importer, in-
cluding with regard to food recalls, outbreaks of 
foodborne illness, and violations of food safety stand-
ards. 
‘‘(4) The rigor and effectiveness of the activities 
conducted by the importer of such article of food to 
satisfy the requirements of the foreign supplier 
verification program under section 805. 
‘‘(5) Whether the food importer participates in 
the voluntary qualified importer program under sec-
tion 806. 
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‘‘(6) Whether the food meets the criteria for 
priority under section 801(h)(1). 
‘‘(7) Whether the food or the facility that man-
ufactured, processed, packed, or held such food re-
ceived a certification as described in section 801(q) 
or 806. 
‘‘(8) Any other criteria deemed necessary and 
appropriate by the Secretary for purposes of allo-
cating inspection resources. 
‘‘(c) INTERAGENCY AGREEMENTS WITH RESPECT TO 
SEAFOOD.— 
‘‘(1) IN GENERAL.—The Secretary of Health 
and Human Services, the Secretary of Commerce, 
the Secretary of Homeland Security, the Chairman 
of the Federal Trade Commission, and the heads of 
other appropriate agencies may enter into such 
agreements as may be necessary or appropriate to 
improve seafood safety. 
‘‘(2) SCOPE OF AGREEMENTS.—The agreements 
under paragraph (1) may include— 
‘‘(A) cooperative arrangements for exam-
ining and testing seafood imports that leverage 
the resources, capabilities, and authorities of 
each party to the agreement; 
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•AMDT. NO. 4805 
‘‘(B) coordination of inspections of foreign 
facilities to increase the percentage of imported 
seafood and seafood facilities inspected; 
‘‘(C) standardization of data on seafood 
names, inspection records, and laboratory test-
ing to improve interagency coordination; 
‘‘(D) coordination to detect and investigate 
violations under applicable Federal law; 
‘‘(E) a process, including the use or modi-
fication of existing processes, by which officers 
and employees of the National Oceanic and At-
mospheric Administration may be duly des-
ignated by the Secretary to carry out seafood 
examinations and investigations under section 
801 of this Act or section 203 of the Food Al-
lergen Labeling and Consumer Protection Act 
of 2004; 
‘‘(F) the sharing of information concerning 
observed noncompliance with United States 
food requirements domestically and in foreign 
nations and new regulatory decisions and poli-
cies that may affect the safety of food imported 
into the United States; 
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•AMDT. NO. 4805 
‘‘(G) conducting joint training on subjects 
that affect and strengthen seafood inspection 
effectiveness by Federal authorities; and 
‘‘(H) outreach on Federal efforts to en-
hance seafood safety and compliance with Fed-
eral food safety requirements. 
‘‘(d) COORDINATION.—The Secretary shall improve 
coordination and cooperation with the Secretary of Agri-
culture and the Secretary of Homeland Security to target 
food inspection resources. 
‘‘(e) FACILITY.—For purposes of this section, the 
term ‘facility’ means a domestic facility or a foreign facil-
ity that is required to register under section 415.’’. 
(b) ANNUAL REPORT.—Section 1003 (21 U.S.C. 
393) is amended by adding at the end the following: 
‘‘(h) ANNUAL
REPORT
REGARDING
FOOD.—Not 
later than February 1 of each year, the Secretary shall 
submit to Congress a report, including efforts to coordi-
nate and cooperate with other Federal agencies with re-
sponsibilities for food inspections, regarding— 
‘‘(1) information about food facilities includ-
ing— 
‘‘(A) the appropriations used to inspect fa-
cilities registered pursuant to section 415 in the 
previous fiscal year; 
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•AMDT. NO. 4805 
‘‘(B) the average cost of both a non-high- 
risk food facility inspection and a high-risk food 
facility inspection, if such a difference exists, in 
the previous fiscal year; 
‘‘(C) the number of domestic facilities and 
the number of foreign facilities registered pur-
suant to section 415 that the Secretary in-
spected in the previous fiscal year; 
‘‘(D) the number of domestic facilities and 
the number of foreign facilities registered pur-
suant to section 415 that were scheduled for in-
spection in the previous fiscal year and which 
the Secretary did not inspect in such year; 
‘‘(E) the number of high-risk facilities 
identified pursuant to section 421 that the Sec-
retary inspected in the previous fiscal year; and 
‘‘(F) the number of high-risk facilities 
identified pursuant to section 421 that were 
scheduled for inspection in the previous fiscal 
year and which the Secretary did not inspect in 
such year. 
‘‘(2) information about food imports includ-
ing— 
‘‘(A) the number of lines of food imported 
into the United States that the Secretary phys-
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•AMDT. NO. 4805 
ically inspected or sampled in the previous fiscal 
year; 
‘‘(B) the number of lines of food imported 
into the United States that the Secretary did 
not physically inspect or sample in the previous 
fiscal year; and 
‘‘(C) the average cost of physically inspect-
ing or sampling a line of food subject to this 
Act that is imported or offered for import into 
the United States; and 
‘‘(3) information on the foreign offices of the 
Food and Drug Administration including— 
‘‘(A) the number of foreign offices estab-
lished; and 
‘‘(B) the number of personnel permanently 
stationed in each foreign office. 
‘‘(i) PUBLIC AVAILABILITY OF ANNUAL FOOD RE-
PORTS.—The Secretary shall make the reports required 
under subsection (h) available to the public on the Internet 
Web site of the Food and Drug Administration.’’. 
(c) ADVISORY COMMITTEE CONSULTATION.—In allo-
cating inspection resources as described in section 421 of 
the Federal Food, Drug, and Cosmetic Act (as added by 
subsection (a)), the Secretary may, as appropriate, consult 
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•AMDT. NO. 4805 
with any relevant advisory committee within the Depart-
ment of Health and Human Services. 
SEC. 6202. LABORATORY ACCREDITATION FOR ANALYSES 
OF FOODS. 
(a) IN GENERAL.—Chapter IV (21 U.S.C. 341 et 
seq.), as amended by section 6201, is amended by adding 
at the end the following: 
‘‘SEC. 422. LABORATORY ACCREDITATION FOR ANALYSES 
OF FOODS. 
‘‘(a) RECOGNITION
OF LABORATORY ACCREDITA-
TION.— 
‘‘(1) IN
GENERAL.—Not later than 2 years 
after the date of enactment of the FDA Food Safety 
Modernization Act, the Secretary shall— 
‘‘(A) establish a program for the testing of 
food by accredited laboratories; 
‘‘(B) establish a publicly available registry 
of accreditation bodies recognized by the Sec-
retary and laboratories accredited by a recog-
nized accreditation body, including the name of, 
contact information for, and other information 
deemed appropriate by the Secretary about 
such bodies and laboratories; and 
‘‘(C) require, as a condition of recognition 
or accreditation, as appropriate, that recognized 
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•AMDT. NO. 4805 
accreditation bodies and accredited laboratories 
report to the Secretary any changes that would 
affect the recognition of such accreditation body 
or the accreditation of such laboratory. 
‘‘(2) PROGRAM REQUIREMENTS.—The program 
established under paragraph (1)(A) shall provide for 
the recognition of laboratory accreditation bodies 
that meet criteria established by the Secretary for 
accreditation of laboratories, including independent 
private laboratories and laboratories run and oper-
ated by a Federal agency (including the Department 
of Commerce), State, or locality with a demonstrated 
capability to conduct 1 or more sampling and analyt-
ical testing methodologies for food. 
‘‘(3) INCREASING THE NUMBER OF QUALIFIED 
LABORATORIES.—The Secretary shall work with the 
laboratory accreditation bodies recognized under 
paragraph (1), as appropriate, to increase the num-
ber of qualified laboratories that are eligible to per-
form testing under subsection (b) beyond the num-
ber so qualified on the date of enactment of the 
FDA Food Safety Modernization Act. 
‘‘(4) LIMITED DISTRIBUTION.—In the interest 
of national security, the Secretary, in coordination 
with the Secretary of Homeland Security, may deter-
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•AMDT. NO. 4805 
mine the time, manner, and form in which the reg-
istry established under paragraph (1)(B) is made 
publicly available. 
‘‘(5) FOREIGN
LABORATORIES.—Accreditation 
bodies recognized by the Secretary under paragraph 
(1) may accredit laboratories that operate outside 
the United States, so long as such laboratories meet 
the accreditation standards applicable to domestic 
laboratories accredited under this section. 
‘‘(6) MODEL
LABORATORY
STANDARDS.—The 
Secretary shall develop model standards that a lab-
oratory shall meet to be accredited by a recognized 
accreditation body for a specified sampling or ana-
lytical testing methodology and included in the reg-
istry provided for under paragraph (1). In devel-
oping the model standards, the Secretary shall con-
sult existing standards for guidance. The model 
standards shall include— 
‘‘(A) methods to ensure that— 
‘‘(i) appropriate sampling, analytical 
procedures (including rapid analytical pro-
cedures), and commercially available tech-
niques are followed and reports of analyses 
are certified as true and accurate; 
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•AMDT. NO. 4805 
‘‘(ii) internal quality systems are es-
tablished and maintained; 
‘‘(iii) procedures exist to evaluate and 
respond promptly to complaints regarding 
analyses and other activities for which the 
laboratory is accredited; and 
‘‘(iv) individuals who conduct the 
sampling and analyses are qualified by 
training and experience to do so; and 
‘‘(B) any other criteria determined appro-
priate by the Secretary. 
‘‘(7) REVIEW
OF
RECOGNITION.—To ensure 
compliance with the requirements of this section, the 
Secretary— 
‘‘(A) shall periodically, and in no case less 
than once every 5 years, reevaluate accredita-
tion bodies recognized under paragraph (1) and 
may accompany auditors from an accreditation 
body to assess whether the accreditation body 
meets the criteria for recognition; and 
‘‘(B) shall promptly revoke the recognition 
of any accreditation body found not to be in 
compliance with the requirements of this sec-
tion, specifying, as appropriate, any terms and 
conditions necessary for laboratories accredited 
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•AMDT. NO. 4805 
by such body to continue to perform testing as 
described in this section. 
‘‘(b) TESTING PROCEDURES.— 
‘‘(1) IN GENERAL.—Not later than 30 months 
after the date of enactment of the FDA Food Safety 
Modernization Act, food testing shall be conducted 
by Federal laboratories or non-Federal laboratories 
that have been accredited for the appropriate sam-
pling or analytical testing methodology or meth-
odologies by a recognized accreditation body on the 
registry established by the Secretary under sub-
section (a)(1)(B) whenever such testing is con-
ducted— 
‘‘(A) by or on behalf of an owner or con-
signee— 
‘‘(i) in response to a specific testing 
requirement under this Act or imple-
menting regulations, when applied to ad-
dress an identified or suspected food safety 
problem; and 
‘‘(ii) as required by the Secretary, as 
the Secretary deems appropriate, to ad-
dress an identified or suspected food safety 
problem; or 
‘‘(B) on behalf of an owner or consignee— 
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•AMDT. NO. 4805 
‘‘(i) in support of admission of an ar-
ticle of food under section 801(a); and 
‘‘(ii) under an Import Alert that re-
quires successful consecutive tests. 
‘‘(2) RESULTS
OF
TESTING.—The results of 
any such testing shall be sent directly to the Food 
and Drug Administration, except the Secretary may 
by regulation exempt test results from such submis-
sion requirement if the Secretary determines that 
such results do not contribute to the protection of 
public health. Test results required to be submitted 
may be submitted to the Food and Drug Adminis-
tration through electronic means. 
‘‘(3) EXCEPTION.—The Secretary may waive 
requirements under this subsection if— 
‘‘(A) a new methodology or methodologies 
have been developed and validated but a labora-
tory has not yet been accredited to perform 
such methodology or methodologies; and 
‘‘(B) the use of such methodology or meth-
odologies are necessary to prevent, control, or 
mitigate a food emergency or foodborne illness 
outbreak. 
‘‘(c) REVIEW BY SECRETARY.—If food sampling and 
testing performed by a laboratory run and operated by a 
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•AMDT. NO. 4805 
State or locality that is accredited by a recognized accredi-
tation body on the registry established by the Secretary 
under subsection (a) result in a State recalling a food, the 
Secretary shall review the sampling and testing results for 
the purpose of determining the need for a national recall 
or other compliance and enforcement activities. 
‘‘(d) NO LIMIT
ON SECRETARIAL AUTHORITY.— 
Nothing in this section shall be construed to limit the abil-
ity of the Secretary to review and act upon information 
from food testing, including determining the sufficiency of 
such information and testing.’’. 
(b) FOOD EMERGENCY RESPONSE NETWORK.—The 
Secretary, in coordination with the Secretary of Agri-
culture, the Secretary of Homeland Security, and State, 
local, and tribal governments shall, not later than 180 
days after the date of enactment of this Act, and biennially 
thereafter, submit to the relevant committees of Congress, 
and make publicly available on the Internet Web site of 
the Department of Health and Human Services, a report 
on the progress in implementing a national food emer-
gency response laboratory network that— 
(1) provides ongoing surveillance, rapid detec-
tion, and surge capacity for large-scale food-related 
emergencies, including intentional adulteration of 
the food supply; 
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