I 
108TH CONGRESS 
1ST SESSION H. R. 3628
To amend the Federal Food, Drug, and Cosmetic Act to facilitate the procure-
ment of safe food by hospitals, nursing homes, schools, and child care 
facilities. 
IN THE HOUSE OF REPRESENTATIVES 
NOVEMBER 21, 2003
Ms. SCHAKOWSKY introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
facilitate the procurement of safe food by hospitals, nurs-
ing homes, schools, and child care facilities.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘National Food Safety 
Database Act of 2003’’. 
SEC. 2. ESTABLISHMENT OF FOOD SAFETY DATABASE. 
Chapter IV of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 341 et seq.) is amended by adding at the 
end the following section:
‘‘SEC. 416. SAFE FOOD SUPPLIER DATABASE FOR HOS-
PITALS, NURSING HOMES, SCHOOLS, AND 
CHILD CARE FACILITIES. 
‘‘(a) IN GENERAL.—
‘‘(1) AVAILABILITY OF FOOD SAFETY INFORMA-
TION.—Through the database under subsection (b), 
the Secretary, in coordination with the Secretary of 
Agriculture and the heads of other appropriate agen-
cies, shall in accordance with this section make 
available to eligible institutions food safety informa-
tion relating to food procurement by the institutions. 
‘‘(2) ELIGIBLE
INSTITUTIONS.—For purposes 
of this section, the term ‘eligible institutions’ 
means—
‘‘(A) hospitals, nursing homes, schools, and 
child care facilities; and 
‘‘(B) such additional institutions as the 
Secretary determines to be appropriate. 
‘‘(b) ELECTRONIC DATABASE.—
‘‘(1) DATABASE.—For purposes of subsection 
(a), the Secretary shall establish and maintain an 
electronic database containing up-to-date food safety 
information. The Secretary shall ensure that the 
database is in operation not later than August 1, 
2005. 
‘‘(2) FOOD SAFETY INFORMATION.—
‘‘(A) IN
GENERAL.—Information is food 
safety information for purposes of this section, 
and shall be included in the database under 
paragraph (1), if the information relates to food 
intended for human consumption that, as deter-
mined by the Secretary—
‘‘(i) is adulterated or misbranded; or 
‘‘(ii) is at risk of being or becoming 
adulterated or misbranded as a result of 
the conditions under which the food is 
manufactured, processed, packed, trans-
ported, or held. 
‘‘(B) CERTAIN INFORMATION.—Food infor-
mation required to be included in the database 
under paragraph (1) includes information relat-
ing to enforcement actions; findings by the Sec-
retary regarding the outbreak of food-borne ill-
ness; recalls of shipments; findings by the Sec-
retary, made in inspections of facilities, that 
significant objectionable conditions exist (relat-
ing to products or processes); and such other 
information regarding food safety concerns as 
the Secretary determines to be appropriate. 
‘‘(C) REGISTRATION
OF
FOOD
FACILI-
TIES.—The second and third sentences of sec-
tion 415(a)(4) shall not apply with respect to 
the inclusion of food safety information in the 
database under paragraph (1). 
‘‘(D) CONFIDENTIALITY.—In including an 
item of information in the database under para-
graph (1), the Secretary shall electronically 
identify, in a manner evident to users of the 
database, items that are confidential. 
‘‘(c) MANNER OF USING DATABASE.—
‘‘(1) AUTHORIZATION OF STATE OFFICIALS.—
‘‘(A) IN
GENERAL.—Upon request of a 
State, the Secretary shall authorize State offi-
cials and employees to have access to the data-
base under subsection (b), subject to the State 
entering into an agreement with the Secretary 
regarding the use of the database. The Sec-
retary may not provide such authorization for 
such an official or employee unless the official 
or employee is recommended by the State to be 
so authorized and—
‘‘(i) is employed in a State agency 
that administers a State law that regulates 
an eligible institution; or 
‘‘(ii) is employed in the principal 
State agency regarding public health.
‘‘(B) STATE ADMINISTRATION.—An agree-
ment under subparagraph (A) shall provide for 
the following: 
‘‘(i) State responsibilities regarding 
the database under subsection (b) will be 
carried out through State officials and em-
ployees authorized under subparagraph 
(A). 
‘‘(ii) Except as provided in clause (iii), 
the State officials or employees who carry 
out database responsibilities regarding a 
type of eligible institution will be officials 
or employees of the State agency referred 
to in subparagraph (A)(i) with respect to 
that type of eligible institution. 
‘‘(iii) The activities of the State re-
garding such database will be under the 
general supervision of an official of the
principal State agency regarding public 
health. 
‘‘(2) ACCESS OF ELIGIBLE INSTITUTIONS.—An 
agreement under paragraph (1) shall provide for the 
following: 
‘‘(A) Upon request of an eligible institution 
in the State, the State will authorize one or
more officials of the institution to receive food 
safety information from the database. 
‘‘(B) Once an official of an eligible institu-
tion has been so authorized, the State will—
‘‘(i) through the Internet or, if the eli-
gible institution does not have Internet ac-
cess, through other electronic means, pro-
vide to the official information in the data-
base that relates to food procurement by 
the institution, as indicated by the sources 
from which the institution obtains food; 
and 
‘‘(ii) in providing the information, 
identify any items of information that are 
considered confidential under subsection 
(f). 
‘‘(d) INTERAGENCY TASK FORCE.—An interagency 
task force shall be established for purposes of facilitating 
coordination among Federal agencies pursuant to sub-
section (a)(1). 
‘‘(e) ADVISORY COMMITTEE.—
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish an advisory committee to make recommenda-
tions to the Secretary regarding the administration 
of this section, including recommendations on the
types of information needed by eligible institutions 
to make informed decisions in purchasing food to 
avoid the purchase of food that may be adulterated 
or misbranded. Not later than six months after the 
date on which the first meeting of the advisory com-
mittee occurs, the committee, in consultation with 
the task force under subsection (d), shall submit to 
the Secretary a report providing the initial rec-
ommendations of the committee regarding the infor-
mation needed by eligible institutions to make such 
informed decisions. 
‘‘(2) COMPOSITION.—The membership of the 
advisory committee under paragraph (1) (referred to 
in this subsection as the ‘advisory committee’) shall 
include, at a minimum, representatives of the fol-
lowing: 
‘‘(A) Anticipated users of the database, in-
cluding State public health officials. 
‘‘(B) Representatives of persons who man-
ufacture, process, pack, transport, or hold food. 
‘‘(C) Representatives of consumer groups. 
‘‘(D) Representatives of Federal agencies 
that have significant responsibilities regarding 
food safety.
‘‘(3) REIMBURSEMENT.—Members of the advi-
sory committee may not be compensated for service 
on the committee. Such members may, in accordance 
with chapter 57 of title 5, United States Code, be 
reimbursed for travel, subsistence, and other nec-
essary expenses incurred in carrying out the duties 
of the committee. 
‘‘(4) INITIAL
MEETING.—The Secretary shall 
ensure that the first meeting of the advisory com-
mittee occurs not later than 90 days after the effec-
tive date of this section. 
‘‘(f) GRANTS.—The Secretary may make grants to 
States for the purpose of assisting the States with the 
costs of providing food safety information to eligible insti-
tutions pursuant to agreements under subsection (c)(1). 
The Secretary may authorize a State that receives such 
a grant to use a portion of the grant to assist eligible insti-
tutions in the State with the costs of obtaining and using 
food safety information pursuant to subsection (c)(2). 
‘‘(g) REGULATIONS.—
‘‘(1) PROGRAM CRITERIA.—The Secretary shall 
by regulation establish criteria for the program 
under this section, including criteria for the partici-
pation of States pursuant to paragraph (1) of sub-
section (c) and the participation of eligible institu-
tions pursuant to paragraph (2) of such subsection. 
‘‘(2) CONFIDENTIALITY.—
‘‘(A) IN
GENERAL.—Regulations under 
paragraph (1) shall include—
‘‘(i) criteria governing the access of 
officials and employees of State agencies 
and eligible institutions to confidential in-
formation in the database under subsection 
(b); and 
‘‘(ii) criteria for the use by such offi-
cials and employees of such information, 
including criteria regarding disclosure of 
the information. 
‘‘(B) CIVIL PENALTY.—Any person who, in 
violation of regulations under subparagraph 
(A), obtains or uses confidential information 
from the database under subsection (b) is liable 
to the United States for a civil penalty in an 
amount to be determined by the Secretary. 
Paragraphs (3) through (5) of section 303(g) 
apply to a civil penalty under the preceding sen-
tence to the same extent and in the same man-
ner as such paragraphs apply to a civil penalty 
under such section.
‘‘(h) DEFINITIONS.—For purposes of this section: 
‘‘(1) The term ‘child care facility’ means any 
public or nonprofit private organization that pro-
vides nonresidential child care, or day care outside 
school hours for school children. 
‘‘(2) The term ‘eligible institution’ has the 
meaning given such term in subsection (a)(2). 
‘‘(3) The term ‘food safety information’ has the 
meaning indicated for such term in subsection (b). 
‘‘(4) The term ‘hospital’ has the meaning given 
such term in section 1861(e) of the Social Security 
Act. 
‘‘(5) The term ‘nursing home’ means a skilled 
nursing facility as defined in section 1819(a) of the 
Social Security Act.’’.
Æ