H. R. 2751—35 
(IV) any other activities that the Secretary 
determines appropriate; 
(iii) an itemization of how grant funds received 
under this subsection will be expended; 
(iv) a description of how adoption of the guidelines 
and implementation of grant activities will be mon-
itored; and 
(v) an agreement by the local educational agency 
to report information required by the Secretary to con-
duct evaluations 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, including lim-
ited medical supplies such as epinephrine and disposable 
wet wipes, to support carrying out the food allergy and 
anaphylaxis management guidelines described in sub-
section (b). 
(B) In partnership with local health departments, 
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 evalua-
tion under this subsection, 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 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 annually. 
(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 respect to the costs to be incurred by 
such local educational agency in carrying out the grant 
activities, the local educational agency shall make available 
(directly or through donations from public or private enti-
ties) non-Federal funds toward such costs in an amount 
equal to not less than 25 percent of the amount of the 
grant.
H. R. 2751—36 
(B) DETERMINATION OF AMOUNT OF NON-FEDERAL CON-
TRIBUTION.—Non-Federal funds required under subpara-
graph (A) may be cash or in kind, including plant, equip-
ment, or services. Amounts provided by the Federal Govern-
ment, and any portion of any service subsidized by the 
Federal Government, may not be included in determining 
the amount of such non-Federal funds. 
(9) ADMINISTRATIVE
FUNDS.—A local educational agency 
that receives a grant under this subsection may use not more 
than 2 percent of the grant amount for administrative costs 
related to carrying out this subsection. 
(10) PROGRESS AND EVALUATIONS.—At the completion of 
the grant period referred to in paragraph (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 avail-
able to carry out the activities described in this subsection. 
(12) AUTHORIZATION OF APPROPRIATIONS.—There is author-
ized 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 anaphylaxis 
management guidelines developed by the Secretary under sub-
section (b) are voluntary. Nothing in this section or the guide-
lines 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 Sec-
retary may enforce an agreement by a local educational agency 
to implement food allergy and anaphylaxis management guide-
lines as a condition of the receipt of a grant under subsection 
(c). 
SEC. 113. 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 subsection (d); and 
(2) by inserting after subsection (b) the following: 
‘‘(c) NOTIFICATION.— 
‘‘(1) IN
GENERAL.—If the Secretary determines that the 
information in a new dietary ingredient notification submitted 
under this section for an article purported to be a new dietary 
ingredient is inadequate to establish that a dietary supplement 
containing 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 steroid, the Secretary shall notify 
the Drug Enforcement Administration of such determination. 
Such notification 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
H. R. 2751—37 
the submission of information regarding the article to the Sec-
retary under this section, and any contact information for such 
person or persons that the Secretary has. 
‘‘(2) DEFINITIONS.—For purposes of this subsection— 
‘‘(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 structure is substantially 
similar to the chemical structure of an anabolic steroid.’’. 
(b) GUIDANCE.—Not later than 180 days after the date of enact-
ment of this Act, the Secretary shall publish guidance that clarifies 
when a dietary supplement ingredient is a new dietary ingredient, 
when the manufacturer or distributor of a dietary ingredient or 
dietary supplement should provide the Secretary with information 
as described 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 methods for establishing the 
identify of a new dietary ingredient. 
SEC. 114. REQUIREMENT FOR GUIDANCE RELATING TO POST HARVEST 
PROCESSING OF RAW OYSTERS. 
(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 Pro-
gram’s Model Ordinance, or the issuance of any guidance or regula-
tion 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 regulations), where such guidance, 
regulation or suggested amendment relates to post harvest proc-
essing for raw oysters, the Secretary shall prepare and submit 
to the Committee 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 include— 
(1) an assessment of how post harvest processing or other 
equivalent controls feasibly may be implemented in the fastest, 
safest, and most economical 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 expected 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 imported from all nations 
of origin; 
(6) an evaluation of alternative measures to prevent, elimi-
nate, or reduce to an acceptable level the occurrence of 
foodborne illness; and 
(7) the extent to which the Food and Drug Administration 
has consulted with the States and other regulatory agencies, 
as appropriate, with regard to post harvest processing meas-
ures. 
(b) LIMITATION.—Subsection (a) shall not apply to the guidance 
described in section 103(h).
H. R. 2751—38 
(c) REVIEW AND EVALUATION.—Not later than 30 days after 
the Secretary issues a proposed regulation or guidance described 
in subsection (a), the Comptroller General of the United States 
shall— 
(1) review and evaluate the report described in (a) and 
report to Congress on the findings of the estimates and analysis 
in the report; 
(2) compare such proposed regulation or guidance to similar 
regulations or guidance with respect to other regulated foods, 
including a comparison of risks the Secretary may find associ-
ated with seafood and the instances of those risks in such 
other regulated foods; and 
(3) evaluate the impact of post harvest processing 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 a guidance 
that is adopted as a consensus agreement between Federal and 
State regulators and the oyster industry, acting through the Inter-
state Shellfish Sanitation Conference. 
(e) PUBLIC ACCESS.—Any report prepared under this section 
shall be made available to the public. 
SEC. 115. PORT SHOPPING. 
Until the date on which the Secretary promulgates a final 
rule that implements the amendments made by section 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 
section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 381(a)) so that the Secretary of Homeland Security, 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. 116. ALCOHOL-RELATED FACILITIES. 
(a) IN GENERAL.—Except as provided by sections 102, 206, 
207, 302, 304, 402, 403, and 404 of 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 condition of doing business in the United States; and 
(2) under section 415 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 350d) is required 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 alcoholic beverages. 
(b) LIMITED
RECEIPT
AND
DISTRIBUTION
OF
NON-ALCOHOL 
FOOD.—Subsection (a) shall not apply to a facility engaged in the 
receipt and distribution of any non-alcohol food, except that such 
paragraph shall apply to a facility described in such paragraph