I

104TH CONGRESS

2D SESSION H. R. 3033

To control the transfer within the United States of infectious agents which

have the potential to pose a severe threat to the public health and

safety, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

MARCH 6, 1996

Mr. MARKEY (for himself, Mr. KASICH, Mr. KENNEDY of Massachusetts, Mr.

FROST, and Mr. JOHNSTON of Florida) introduced the following bill;

which was referred to the Committee on Commerce

A BILL

To control the transfer within the United States of infectious

agents which have the potential to pose a severe threat

to the public health and safety, and for other purposes.

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 ‘‘Infectious Agents Con5 trol Act of 1996’’.

6 SEC. 2. FINDINGS.

7 The Congress finds that—
2

•HR 3033 IH

1 (1) certain infectious agents have the potential

2 to pose a severe threat to the public health and safe3 ty;

4 (2) such agents could be used as weapons by in5 dividuals or organizations for the purpose of domes6 tic or international terrorism or for other criminal

7 purposes;

8 (3) transfer and possession of potentially haz9 ardous infectious agents must be regulated in order

10 to protect the public health and safety; and

11 (4) efforts to protect the public from exposure

12 to such agents must also ensure that individuals and

13 groups with legitimate research objectives continue

14 to have access to such agents when they are needed

15 to achieve those objectives.

16 SEC. 3. TIME LIMITS FOR RULES REGARDING THE CON17 TROL OF TRANSFERS OF CERTAIN INFEC18 TIOUS AGENTS WITHIN THE UNITED STATES.

19 The Secretary of Health and Human Services shall

20 issue—

21 (1) proposed rules not later than 180 days after

22 the date of the enactment of this Act; and

23 (2) final rules not later than 360 days after the

24 date of the enactment of this Act,
3

•HR 3033 IH

1 to regulate the transfer within the United States of infec2 tious agents which have the potential to pose a severe

3 threat to the public health and safety.

4 SEC. 4. SCOPE OF RULES.

5 In the rules under section 3, the Secretary shall—

6 (1) establish and maintain a list of infectious

7 agents which have the potential to pose a severe

8 threat to the public health and safety under section

9 5; and

10 (2) regulate the transfer of such agents under

11 section 6.

12 SEC. 5. LIST OF INFECTIOUS AGENTS THAT HAVE THE PO13 TENTIAL TO POSE A SEVERE THREAT TO THE

14 PUBLIC HEALTH AND SAFETY.

15 The Secretary, in determining whether to include a

16 particular agent on the list required under section 4(1),

17 shall—

18 (1) consider—

19 (A) the effect on human health of exposure

20 to such agent;

21 (B) the degree of contagiousness of such

22 agent and the method of transfer to humans;

23 (C) the availability and effectiveness of im24 munizations to prevent and treatments for ill-
4

•HR 3033 IH

1 ness resulting from infection from such agent;

2 and

3 (D) any other criteria the Secretary deems

4 appropriate; and

5 (2) consult with scientific experts representing

6 appropriate professional groups.

7 SEC. 6. REGULATION OF TRANSFERS OF LISTED INFEC8 TIOUS AGENTS.

9 The regulation required under section 4(2) shall pro10 vide for—

11 (1) the establishment and enforcement of safety

12 procedures for transferors and transferees of agents

13 listed under section 5, including measures to—

14 (A) ensure proper training and appropriate

15 skills to handle such agents; and

16 (B) ensure proper laboratory facilities to

17 contain and to dispose of such agents;

18 (2) safeguards to prevent access to such agents

19 for use in domestic or international terrorism or for

20 any other criminal purposes;

21 (3) the establishment and enforcement of proce22 dures to protect the public safety in case of a trans23 fer or potential transfer of such agents in violation

24 of paragraphs (1) or (2); and
5

•HR 3033 IH

1 (4) appropriate availability of such agents for

2 research, education, or other legitimate purposes.

3 SEC. 7. ENFORCEMENT.

4 (a) CIVIL PENALTY.—The Secretary may assess a

5 civil penalty of not more than $5,000 against a person

6 who negligently violates a rule made to carry out sections

7 6(1) through 6(3).

8 (b) PROCEDURES.—The provisions of subsections (c)

9 through (l) of section 1128A of the Social Security Act

10 (42 U.S.C. 1320a–7a) apply to civil money penalties under

11 this section in the same manner as they apply to a civil

12 penalty or proceeding under section 1128A(a) of such Act.

13 (c) CRIMINAL PENALTY.—Whoever knowingly vio14 lates a rule made to carry out sections 6(1) through 6(3)

15 shall be fined under title 18, United States Code, or im16 prisoned for not more than 5 years, or both.

Æ