I 

108TH CONGRESS 

1ST SESSION H. R. 3628

To amend the Federal Food, Drug, and Cosmetic Act to facilitate the procurement 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, nursing homes, schools, and child care facilities.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘National Food Safety 

5 Database Act of 2003’’. 

6 SEC. 2. ESTABLISHMENT OF FOOD SAFETY DATABASE. 

7 Chapter IV of the Federal Food, Drug, and Cosmetic 

8 Act (21 U.S.C. 341 et seq.) is amended by adding at the 

9 end the following section: 
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1 ‘‘SEC. 416. SAFE FOOD SUPPLIER DATABASE FOR HOS2 PITALS, NURSING HOMES, SCHOOLS, AND 

3 CHILD CARE FACILITIES. 

4 ‘‘(a) IN GENERAL.—

5 ‘‘(1) AVAILABILITY OF FOOD SAFETY INFORMA6 TION.—Through the database under subsection (b), 

7 the Secretary, in coordination with the Secretary of 

8 Agriculture and the heads of other appropriate agen9 cies, shall in accordance with this section make 

10 available to eligible institutions food safety informa11 tion relating to food procurement by the institutions. 

12 ‘‘(2) ELIGIBLE INSTITUTIONS.—For purposes 

13 of this section, the term ‘eligible institutions’ 

14 means—

15 ‘‘(A) hospitals, nursing homes, schools, and 

16 child care facilities; and 

17 ‘‘(B) such additional institutions as the 

18 Secretary determines to be appropriate. 

19 ‘‘(b) ELECTRONIC DATABASE.—

20 ‘‘(1) DATABASE.—For purposes of subsection 

21 (a), the Secretary shall establish and maintain an 

22 electronic database containing up-to-date food safety 

23 information. The Secretary shall ensure that the 

24 database is in operation not later than August 1, 

25 2005. 

26 ‘‘(2) FOOD SAFETY INFORMATION.—
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1 ‘‘(A) IN GENERAL.—Information is food 

2 safety information for purposes of this section, 

3 and shall be included in the database under 

4 paragraph (1), if the information relates to food 

5 intended for human consumption that, as deter6 mined by the Secretary—

7 ‘‘(i) is adulterated or misbranded; or 

8 ‘‘(ii) is at risk of being or becoming 

9 adulterated or misbranded as a result of 

10 the conditions under which the food is 

11 manufactured, processed, packed, trans12 ported, or held. 

13 ‘‘(B) CERTAIN INFORMATION.—Food infor14 mation required to be included in the database 

15 under paragraph (1) includes information relat16 ing to enforcement actions; findings by the Sec17 retary regarding the outbreak of food-borne ill18 ness; recalls of shipments; findings by the Sec19 retary, made in inspections of facilities, that 

20 significant objectionable conditions exist (relat21 ing to products or processes); and such other 

22 information regarding food safety concerns as 

23 the Secretary determines to be appropriate. 

24 ‘‘(C) REGISTRATION OF FOOD FACILI25 TIES.—The second and third sentences of sec-
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1 tion 415(a)(4) shall not apply with respect to 

2 the inclusion of food safety information in the 

3 database under paragraph (1). 

4 ‘‘(D) CONFIDENTIALITY.—In including an 

5 item of information in the database under para6 graph (1), the Secretary shall electronically 

7 identify, in a manner evident to users of the 

8 database, items that are confidential. 

9 ‘‘(c) MANNER OF USING DATABASE.—

10 ‘‘(1) AUTHORIZATION OF STATE OFFICIALS.—

11 ‘‘(A) IN GENERAL.—Upon request of a 

12 State, the Secretary shall authorize State offi13 cials and employees to have access to the data14 base under subsection (b), subject to the State 

15 entering into an agreement with the Secretary 

16 regarding the use of the database. The Sec17 retary may not provide such authorization for 

18 such an official or employee unless the official 

19 or employee is recommended by the State to be 

20 so authorized and—

21 ‘‘(i) is employed in a State agency 

22 that administers a State law that regulates 

23 an eligible institution; or 

24 ‘‘(ii) is employed in the principal 

25 State agency regarding public health. 
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1 ‘‘(B) STATE ADMINISTRATION.—An agree2 ment under subparagraph (A) shall provide for 

3 the following: 

4 ‘‘(i) State responsibilities regarding 

5 the database under subsection (b) will be 

6 carried out through State officials and em7 ployees authorized under subparagraph 

8 (A). 

9 ‘‘(ii) Except as provided in clause (iii), 

10 the State officials or employees who carry 

11 out database responsibilities regarding a 

12 type of eligible institution will be officials 

13 or employees of the State agency referred 

14 to in subparagraph (A)(i) with respect to 

15 that type of eligible institution. 

16 ‘‘(iii) The activities of the State re17 garding such database will be under the 

18 general supervision of an official of the

19 principal State agency regarding public 

20 health. 

21 ‘‘(2) ACCESS OF ELIGIBLE INSTITUTIONS.—An 

22 agreement under paragraph (1) shall provide for the 

23 following: 

24 ‘‘(A) Upon request of an eligible institution 

25 in the State, the State will authorize one or 
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1 more officials of the institution to receive food 

2 safety information from the database. 

3 ‘‘(B) Once an official of an eligible institu4 tion has been so authorized, the State will—

5 ‘‘(i) through the Internet or, if the eli6 gible institution does not have Internet ac7 cess, through other electronic means, pro8 vide to the official information in the data9 base that relates to food procurement by 

10 the institution, as indicated by the sources 

11 from which the institution obtains food; 

12 and 

13 ‘‘(ii) in providing the information, 

14 identify any items of information that are 

15 considered confidential under subsection 

16 (f). 

17 ‘‘(d) INTERAGENCY TASK FORCE.—An interagency 

18 task force shall be established for purposes of facilitating 

19 coordination among Federal agencies pursuant to sub20 section (a)(1). 

21 ‘‘(e) ADVISORY COMMITTEE.—

22 ‘‘(1) IN GENERAL.—The Secretary shall estab23 lish an advisory committee to make recommenda24 tions to the Secretary regarding the administration 

25 of this section, including recommendations on the 
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1 types of information needed by eligible institutions 

2 to make informed decisions in purchasing food to 

3 avoid the purchase of food that may be adulterated 

4 or misbranded. Not later than six months after the 

5 date on which the first meeting of the advisory com6 mittee occurs, the committee, in consultation with 

7 the task force under subsection (d), shall submit to 

8 the Secretary a report providing the initial rec9 ommendations of the committee regarding the infor10 mation needed by eligible institutions to make such 

11 informed decisions. 

12 ‘‘(2) COMPOSITION.—The membership of the 

13 advisory committee under paragraph (1) (referred to 

14 in this subsection as the ‘advisory committee’) shall 

15 include, at a minimum, representatives of the fol16 lowing: 

17 ‘‘(A) Anticipated users of the database, in18 cluding State public health officials. 

19 ‘‘(B) Representatives of persons who man20 ufacture, process, pack, transport, or hold food. 

21 ‘‘(C) Representatives of consumer groups. 

22 ‘‘(D) Representatives of Federal agencies 

23 that have significant responsibilities regarding 

24 food safety. 
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1 ‘‘(3) REIMBURSEMENT.—Members of the advi2 sory committee may not be compensated for service 

3 on the committee. Such members may, in accordance 

4 with chapter 57 of title 5, United States Code, be 

5 reimbursed for travel, subsistence, and other nec6 essary expenses incurred in carrying out the duties 

7 of the committee. 

8 ‘‘(4) INITIAL MEETING.—The Secretary shall 

9 ensure that the first meeting of the advisory com10 mittee occurs not later than 90 days after the effec11 tive date of this section. 

12 ‘‘(f) GRANTS.—The Secretary may make grants to 

13 States for the purpose of assisting the States with the 

14 costs of providing food safety information to eligible insti15 tutions pursuant to agreements under subsection (c)(1). 

16 The Secretary may authorize a State that receives such 

17 a grant to use a portion of the grant to assist eligible insti18 tutions in the State with the costs of obtaining and using 

19 food safety information pursuant to subsection (c)(2). 

20 ‘‘(g) REGULATIONS.—

21 ‘‘(1) PROGRAM CRITERIA.—The Secretary shall 

22 by regulation establish criteria for the program 

23 under this section, including criteria for the partici24 pation of States pursuant to paragraph (1) of sub-
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1 section (c) and the participation of eligible institu2 tions pursuant to paragraph (2) of such subsection. 

3 ‘‘(2) CONFIDENTIALITY.—

4 ‘‘(A) IN GENERAL.—Regulations under 

5 paragraph (1) shall include—

6 ‘‘(i) criteria governing the access of 

7 officials and employees of State agencies 

8 and eligible institutions to confidential in9 formation in the database under subsection 

10 (b); and 

11 ‘‘(ii) criteria for the use by such offi12 cials and employees of such information, 

13 including criteria regarding disclosure of 

14 the information. 

15 ‘‘(B) CIVIL PENALTY.—Any person who, in 

16 violation of regulations under subparagraph 

17 (A), obtains or uses confidential information 

18 from the database under subsection (b) is liable 

19 to the United States for a civil penalty in an 

20 amount to be determined by the Secretary. 

21 Paragraphs (3) through (5) of section 303(g) 

22 apply to a civil penalty under the preceding sen23 tence to the same extent and in the same man24 ner as such paragraphs apply to a civil penalty 

25 under such section. 
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1 ‘‘(h) DEFINITIONS.—For purposes of this section: 

2 ‘‘(1) The term ‘child care facility’ means any 

3 public or nonprofit private organization that pro4 vides nonresidential child care, or day care outside 

5 school hours for school children. 

6 ‘‘(2) The term ‘eligible institution’ has the 

7 meaning given such term in subsection (a)(2). 

8 ‘‘(3) The term ‘food safety information’ has the 

9 meaning indicated for such term in subsection (b). 

10 ‘‘(4) The term ‘hospital’ has the meaning given 

11 such term in section 1861(e) of the Social Security 

12 Act. 

13 ‘‘(5) The term ‘nursing home’ means a skilled 

14 nursing facility as defined in section 1819(a) of the 

15 Social Security Act.’’.

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