II

106TH CONGRESS

2D SESSION S. 3202

To amend title 18, United States Code, with respect to biological weapons.

IN THE SENATE OF THE UNITED STATES

OCTOBER 12 (legislative day, SEPTEMBER 22), 2000

Mr. BIDEN introduced the following bill; which was read twice and referred

to the Committee on the Judiciary

A BILL

To amend title 18, United States Code, with respect to

biological weapons.

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 ‘‘Dangerous Biological

5 Agent and Toxin Control Act of 2000’’.

6 SEC. 2. EXPANSION OF THE BIOLOGICAL WEAPONS STAT7 UTE.

8 (a) FINDINGS AND PURPOSES.—

9 (1) FINDINGS.—Congress finds that—

10 (A) certain biological agents and toxins

11 have the potential to pose a severe threat to the
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1 Nation’s public health and safety, and thereby

2 affect interstate and foreign commerce;

3 (B) the Secretary of Health and Human

4 Services has published a list of biological agents

5 and toxins that pose a severe threat to the Na6 tion’s public health and safety as an appendix

7 to part 72 of title 42, Code of Federal Regula8 tions;

9 (C) biological agents and toxins can be

10 used as weapons by individuals or organizations

11 for the purpose of domestic or international ter12 rorism or for other criminal purposes;

13 (D) terrorists and other criminals can also

14 harm national security, drain the limited re15 sources of all levels of government devoted to

16 thwarting biological weapons, and damage

17 interstate and foreign commerce by threatening

18 to use, and by falsely reporting efforts to use,

19 biological agents and toxins as weapons;

20 (E) the Biological Weapons Convention ob21 ligates the United States to take necessary

22 measures within the United States to prohibit

23 and prevent the development, production, stock24 piling, acquisition, or retention of biological

25 agents and toxins of types and in quantities
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1 that have no justification for prophylactic, pro2 tective, or other peaceful purposes;

3 (F) the mere possession of biological

4 agents and toxins is a potential danger that af5 fects the obligations of the United States under

6 the Biological Weapons Convention and affects

7 interstate and foreign commerce; and

8 (G) persons in possession of harmful bio9 logical agents and toxins should handle them in

10 a safe manner and, in the case of agents and

11 toxins listed by the Department of Health and

12 Human Services as posing a severe threat to

13 the Nation’s public health and safety, report

14 their possession and the purpose for their pos15 session to the appropriate Federal agency in

16 order to ensure that such possession is for

17 peaceful scientific research or development.

18 (2) PURPOSES.—The purposes of this section

19 are to—

20 (A) strengthen the implementation by the

21 United States of the Biological Weapons Con22 vention and to ensure that biological agents and

23 toxins are possessed for only prophylactic, pro24 tective, or other peaceful purposes;
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1 (B) establish penalties for the false report2 ing of violations of chapter 10 of title 18,

3 United States Code (relating to biological weap4 ons); and

5 (C) improve the statutory definitions relat6 ing to biological weapons.

7 (b) ADDITIONAL MEASURES.—

8 (1) IN GENERAL.—Section 175 of title 18,

9 United States Code, is amended by adding at the

10 end the following:

11 ‘‘(c) ADDITIONAL PROHIBITIONS RELATING TO BIO12 LOGICAL AGENTS, TOXINS, AND DELIVERY SYSTEMS.—

13 ‘‘(1) UNLAWFUL POSSESSION.—Whoever know14 ingly possesses any biological agent, toxin, or deliv15 ery system of a type or in a quantity that, under the

16 circumstances, is not reasonably justified by a pro17 phylactic, protective, or other peaceful purpose, shall

18 be fined under this title, imprisoned not more than

19 10 years, or both. Knowledge of whether the type or

20 quantity of any biological agent, toxin, or delivery

21 system is reasonably justified by a prophylactic, pro22 tective, or other peaceful purpose is not an element

23 of the offense. For purposes of this paragraph, the

24 terms ‘biological agent’ and ‘toxin’ do not encompass

25 any biological agent or toxin that is in its naturally
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1 occurring environment, if such agent or toxin has

2 not been cultivated, collected, or otherwise extracted

3 from its natural source.

4 ‘‘(2) UNSAFE HANDLING.—

5 ‘‘(A) IN GENERAL.—Whoever, with con6 scious disregard of an unreasonable risk to pub7 lic health and safety, handles an item knowing

8 it to be a biological agent, toxin, or delivery sys9 tem in a manner that grossly deviates from ac10 cepted norms, shall be fined under this title,

11 imprisoned not more than 1 year, or both.

12 ‘‘(B) AGGRAVATED OFFENSE.—Whoever in

13 the course of a violation of subparagraph (A)

14 causes bodily injury (as defined in section

15 1365(g)(4) of this title) to any individual (other

16 than the perpetrator)—

17 ‘‘(i) shall be fined under this title, im18 prisoned not more than 10 years, or both;

19 and

20 ‘‘(ii) if death results from the offense,

21 shall be fined under this title, imprisoned

22 for any term of years or for life, or both

23 fined and imprisoned.

24 ‘‘(d) FALSE INFORMATION.—
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1 ‘‘(1) CRIMINAL VIOLATION.—Whoever commu2 nicates information, knowing the information to be

3 false and under circumstances in which such infor4 mation may reasonably be believed, concerning the

5 existence of activity that would constitute a violation

6 of subsection (a) or (c) shall be fined under this

7 title, imprisoned not more than 5 years, or both.

8 ‘‘(2) CIVIL PENALTY.—Whoever communicates

9 information, knowing the information to be false,

10 concerning the existence of activity that would con11 stitute a violation of subsection (a) or (c) is liable

12 to the United States or any State for a civil penalty

13 of the greater of $10,000 or the amount of money

14 expended by the United States or the State in re15 sponding to the false information.

16 ‘‘(e) REPORTING, TRANSFER, AND POSSESSION OF

17 SELECT AGENTS.—

18 ‘‘(1) OBLIGATION TO REPORT.—Any person

19 who possesses a select agent shall report such pos20 session to the designated agency, in the manner pre21 scribed by the designated agency, within 72 hours of

22 the effective date of the regulation issued by that

23 agency pursuant to this paragraph or within 72

24 hours of subsequently obtaining possession of the

25 agent or toxin, except that, if such person is a reg-
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1 istered entity, the reporting, if any, shall be in the

2 manner as otherwise directed by regulation by the

3 designated agency. If a person complies with this

4 paragraph, there is no obligation for any employee

5 of such person to file a separate report concerning

6 the employee’s possession of a select agent in the

7 workplace of such person.

8 ‘‘(2) CRIMINAL PENALTY FOR WILLFUL FAIL9 URE TO REPORT.—Any person who willfully fails to

10 make the report required by paragraph (1) within

11 the prescribed period shall be fined under this title,

12 imprisoned not more than 3 years, or both. In this

13 paragraph, the term ‘willfully’ means an intentional

14 violation of a known duty to report.

15 ‘‘(3) CIVIL PENALTY FOR FAILURE TO RE16 PORT.—Any person who fails to make the report re17 quired by paragraph (1) within the prescribed period

18 is liable to the United States for a civil penalty of

19 $5,000.

20 ‘‘(4) PENALTY FOR POSSESSION OF UNRE21 PORTED SELECT AGENTS.—Any person who know22 ingly possesses a biological agent or toxin that is a

23 select agent for which a report required by para24 graph (1) has not been made shall be fined under

25 this title, imprisoned not more than 1 year, or both.
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1 ‘‘(5) UNAUTHORIZED TRANSFER OF SELECT

2 AGENTS.—Whoever knowingly transfers a select

3 agent to any person who is not a registered entity

4 shall be fined under this title, imprisoned not more

5 than 5 years, or both. For purposes of this para6 graph, the term ‘transfers’ does not encompass the

7 transfer of a select agent within the workplace be8 tween employees of the same registered entity, or be9 tween employees of any person who has filed the re10 port required by paragraph (1), if the transfer is au11 thorized by such entity or person.

12 ‘‘(6) POSSESSION OF SELECT AGENTS BY RE13 STRICTED INDIVIDUALS.—

14 ‘‘(A) PROHIBITION ON POSSESSION.—Ex15 cept as otherwise provided in this section or in

16 section 2(b)(3)(G) of the Dangerous Biological

17 Agent and Toxin Control Act of 2000, no re18 stricted individual shall knowingly possess or

19 attempt to possess any biological agent or toxin

20 if that biological agent or toxin is a select

21 agent.

22 ‘‘(B) PENALTY.—Any individual who vio23 lates subparagraph (A) shall be fined under this

24 title, imprisoned not more than 5 years, or

25 both.
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1 ‘‘(C) EMPLOYERS OF INDIVIDUALS WHO

2 POSSESS SELECT AGENTS.—Employers of indi3 viduals who will possess select agents in the

4 course of their employment shall require such

5 individuals, prior to being given access to select

6 agents, to complete a form in which the indi7 vidual affirms or denies the existence of each of

8 the restrictions set forth in section 178(8) of

9 this title. In the case of individuals already em10 ployed as of the date of enactment of this sub11 section who possess select agents in the course

12 of their employment, employers shall, not later

13 than 90 days after the date of enactment of

14 this subsection, require those individuals to

15 complete such a form. Such form shall be re16 tained by the employer for not less than 5 years

17 after the individual terminates his employment

18 with that employer.

19 ‘‘(D) EMPLOYEES.—

20 ‘‘(i) Whoever willfully and knowingly

21 falsifies or conceals a material fact or

22 makes any materially false, fictitious, or

23 fraudulent statement or representation in

24 completing the form required under sub25 paragraph (C) shall be fined under this
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1 title, imprisoned not more than 5 years, or

2 both.

3 ‘‘(ii) The prohibition of subparagraph

4 (A) does not apply to possession by a re5 stricted individual of a select agent in the

6 workplace of his employer if the basis for

7 the prohibition relates solely to subpara8 graph (A) or (B)(i) of section 178(8) of

9 this title and a determination is made to

10 waive the prohibition in accordance with

11 the rules and procedures established pursu12 ant to subsection (f).

13 ‘‘(iii) The prohibition of subparagraph

14 (A) does not apply to possession by a re15 stricted individual of a select agent in the

16 workplace of his employer if the basis for

17 the prohibition relates solely to subpara18 graph (B)(ii) or (G) of section 178(8) of

19 this title and is more than 5 years old (not

20 counting time served while in custody), and

21 a determination is made to waive the pro22 hibition in accordance with the rules and

23 procedures established pursuant to sub24 section (f).
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1 ‘‘(iv) For the purposes of this sub2 paragraph, the term ‘employer’ means any

3 person who is a registered entity or has

4 filed the report required by section

5 175(e)(1) of this title and employs a re6 stricted individual.

7 ‘‘(E) CERTAIN NONPERMANENT RESIDENT

8 ALIENS.—The prohibition of subparagraph (A)

9 does not apply to possession by a restricted in10 dividual of a select agent if the basis for the

11 prohibition relates solely to subparagraph (F)

12 of section 178(8) of this title, and the restricted

13 individual has received a waiver from the agen14 cy designated to carry out the functions of this

15 subparagraph. The designated agency may issue

16 a waiver if it determines, in consultation with

17 the Attorney General, that a waiver is in the

18 public interest.

19 ‘‘(f) WAIVERS OF RESTRICTIONS ON POSSESSION OF

20 SELECT AGENTS IN COURSE OF EMPLOYMENT.—The

21 agency designated to carry out this subsection, after con22 sultation with appropriate agencies, with representatives

23 of the scientific and medical community, and with other

24 appropriate public and private entities and organizations

25 (including consultation concerning employment practices
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1 in working with select agents), shall establish the rules

2 and procedures governing waivers of the provisions of sub3 section (e)(6)(A) with respect to possession of select

4 agents by restricted individuals in the course of employ5 ment. Such rules and procedures shall address, among

6 other matters as found appropriate by the designated

7 agency, whether (or the circumstances under or the extent

8 to which) the determination to grant a waiver shall be re9 served to the Government, or may be made by the em10 ployer (either with or without consultation with the Gov11 ernment).

12 ‘‘(g) REIMBURSEMENT OF COSTS.—

13 ‘‘(1) CONVICTED DEFENDANT.—

14 ‘‘(A) SUBSECTION (a), (c), OR (e).—The

15 court shall order any person convicted of an of16 fense under subsection (a), (c), or (e) to reim17 burse the United States or any State for any

18 expenses incurred by the United States or the

19 State incident to the seizure, storage, handling,

20 transportation, and destruction or other dis21 posal of any property that was seized in connec22 tion with an investigation of the commission of

23 such offense by that person.

24 ‘‘(B) SUBSECTION (d)(1).—The court shall

25 order any person convicted of an offense under
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1 subsection (d)(1) to reimburse the United

2 States for any expenses incurred by the United

3 States incident to the investigation of the com4 mission by that person of such offense, includ5 ing the cost of any response made by any Fed6 eral military or civilian agency to protect public

7 health or safety.

8 ‘‘(2) OWNER LIABILITY.—The owner or pos9 sessor of any property seized and forfeited under

10 this chapter shall be liable to the United States for

11 any expenses incurred incident to the seizure and

12 forfeiture, including any expenses relating to the

13 handling, storage, transportation, and destruction or

14 other disposition of the seized and forfeited property.

15 ‘‘(3) JOINTLY AND SEVERALLY LIABLE.—A

16 person ordered to reimburse the United States for

17 expenses under this chapter shall be jointly and sev18 erally liable for such expenses with each other per19 son, if any, who is ordered under this subsection to

20 reimburse the United States for the same ex21 penses.’’.

22 (2) TECHNICAL CLARIFICATIONS.—

23 (A) SECTION 175.—Section 175(a) of title

24 18, United States Code, is amended by striking

25 ‘‘section’’ and inserting ‘‘subsection’’.
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1 (B) SECTION 176.—Section 176(a)(1)(A)

2 of title 18, United States Code, is amended by

3 striking ‘‘exists by reason of’’ and inserting

4 ‘‘pertains to’’.

5 (3) DESIGNATION OF RESPONSIBLE AGEN6 CIES.—

7 (A) IN GENERAL.—Not later than 60 days

8 after the date of enactment of this Act, the

9 President shall designate—

10 (i) the agency responsible for pre11 scribing the regulation required by section

12 175(e)(1) of title 18, United States Code;

13 (ii) the agency responsible for grant14 ing the waivers under section 175(e)(6)(E)

15 of title 18, United States Code; and

16 (iii) the agency responsible for imple17 menting the waiver provisions of section

18 175(f) of title 18, United States Code.

19 (B) REGULATIONS.—The agencies des20 ignated pursuant to subparagraph (A)—

21 (i) shall issue proposed rules not later

22 than 90 days after the date of the Presi23 dent’s designation; and
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1 (ii) shall issue final rules not later

2 than 270 days after the date of enactment

3 of this Act.

4 (C) INSPECTIONS.—The agency designated

5 pursuant to subparagraph (A)(i) may inspect

6 the facilities of any person who files a report re7 quired by section 175(e)(1) of title 18, United

8 States Code, to determine whether the person is

9 handling the select agent in a safe manner,

10 whether he is holding such agent for a prophy11 lactic, protective, or other peaceful purpose, and

12 whether the type and quantity being held are

13 reasonable for that purpose. Any agency des14 ignated pursuant to subparagraph (A) may in15 spect any form required by section 175(e)(6)(C)

16 of title 18, United States Code, and any docu17 mentation relating to a determination made

18 pursuant to section 175(e)(6)(D) of that title.

19 The designated agency shall endeavor to not

20 interfere with the normal business operations of

21 any such facility.

22 (D) FREEDOM OF INFORMATION ACT EX23 EMPTION.—Any information provided to the

24 Secretary of Health and Human Services pur25 suant to regulations issued under section 511(f)
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1 of the Antiterrorism and Effective Death Pen2 alty Act of 1996 (42 C.F.R. 72.6) or to the

3 designated agency under section 175(e)(1) of

4 title 18, United States Code, shall not be dis5 closed under section 552 of title 5, United

6 States Code. The Secretary or the designated

7 agency may use and disclose such information

8 to protect the public health, and shall also dis9 close any such relevant information to the At10 torney General for use in any investigation or

11 other proceeding to enforce any law relating to

12 select agents or any other law. Any such infor13 mation shall be made available to any com14 mittee or subcommittee of Congress with appro15 priate jurisdiction upon the written request of

16 the Chairman or Ranking Member of such com17 mittee or subcommittee, except that no such

18 committee or subcommittee, and no member

19 and no staff member of such committee or sub20 committee, shall disclose such information ex21 cept as otherwise required or authorized by law.

22 (E) CLARIFICATION OF THE SCOPE OF

23 THE SELECT AGENT RULE.—Section 511 of the

24 Antiterrorism and Effective Death Penalty Act
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1 of 1996 (Public Law 104–132; 110 Stat. 1284)

2 is amended—

3 (i) in each of subsections (a), (d), and

4 (e)—

5 (I) by inserting ‘‘and toxins’’

6 after ‘‘agents’’ each place it appears;

7 and

8 (II) by inserting ‘‘or toxin’’ after

9 ‘‘agent’’ each place it appears; and

10 (ii) in subsection (g)(1), by striking

11 ‘‘the term ‘biological agent’ has’’ and in12 serting ‘‘the terms ‘biological agent’ and

13 ‘toxin’ have’’.

14 (F) EFFECTIVE DATES.—

15 (i) Subparagraph (D) shall take effect

16 on the effective date for the final rule

17 issued pursuant to section 511(d)(1) of the

18 Antiterrorism and Effective Death Penalty

19 Act of 1996 (Public Law 104–132; 110

20 Stat. 1284).

21 (ii) The amendments made by sub22 paragraph (E) shall take effect as if in23 cluded in the enactment of section 511 of

24 the Antiterrorism and Effective Death
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1 Penalty Act of 1996 (Public Law 104–132;

2 110 Stat. 1284).

3 (G) TRANSITIONAL EXEMPTIONS.—

4 (i) The prohibition created by section

5 175(e)(6)(A) of title 18, United States

6 Code, shall not apply to the possession of

7 a select agent in the workplace of an em8 ployer (as defined in section

9 175(e)(6)(D)(iv) of title 18, United States

10 Code) by a restricted individual (as defined

11 in subparagraph (A), (B), or (G) of section

12 178(8) of title 18, United States Code),

13 until the effective date of the regulations

14 issued to implement section 175(f) of title

15 18, United States Code, or 270 days after

16 the date of enactment of this Act, which17 ever occurs earlier.

18 (ii) The prohibition created by section

19 175(e)(6)(A) of title 18, United States

20 Code, shall not apply to the possession of

21 a select agent by a restricted individual (as

22 defined in section 178(8)(F) of title 18,

23 United States Code), until the effective

24 date of the regulations issued to implement

25 section 175(e)(6)(E) of title 18, United
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1 States Code, or 270 days after the enact2 ment of this Act, whichever occurs earlier.

3 (c) DEFINITIONAL AMENDMENTS.—

4 (1) SECTION 178.—Section 178 of title 18,

5 United States Code, is amended—

6 (A) in paragraph (1), by striking ‘‘means

7 any microorganism, virus, or infectious sub8 stance, or biological product that may be engi9 neered as a result of biotechnology, or any nat10 urally occurring or bioengineered component of

11 any such microorganism, virus, infectious sub12 stance, or biological product’’ and inserting the

13 following: ‘‘means any microorganism (includ14 ing, but not limited to, bacteria, viruses, fungi,

15 rickettsiae, or protozoa), or infectious sub16 stance, or any naturally occurring, bioengi17 neered or synthesized component of any such

18 microorganism or infectious substance’’;

19 (B) in paragraph (2), by striking ‘‘means

20 the toxic material of plants, animals, microorga21 nisms, viruses, fungi, or infectious substances,

22 or a recombinant molecule, whatever its origin

23 or method of production, including’’ and insert24 ing the following: ‘‘means the toxic material or

25 product of plants, animals, microorganisms (in-
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1 cluding, but not limited to, bacteria, viruses,

2 fungi, rickettsiae, or protozoa), or infectious

3 substances, or a recombinant or synthesized

4 molecule, whatever their origin and method of

5 production, and includes’’;

6 (C) in paragraph (4)—

7 (i) by striking ‘‘recombinant molecule,

8 or biological product that may be engi9 neered as a result of biotechnology’’ and

10 inserting ‘‘recombinant or synthesized mol11 ecule’’; and

12 (ii) by striking ‘‘and’’ at the end;

13 (D) in paragraph (5), by striking the pe14 riod at the end and inserting a semicolon; and

15 (E) by adding at the end the following:

16 ‘‘(6) the term ‘select agent’ means a biological

17 agent or toxin that is on the list established by the

18 Secretary of Health and Human Services pursuant

19 to section 511(d)(1) of the Antiterrorism and Effec20 tive Death Penalty Act of 1996 (Public Law 104–

21 132; 110 Stat. 1284) that is not exempted under

22 part 72.6(h) of title 42, Code of Federal Regulations

23 or appendix A to such part (or any successor to ei24 ther such provision), except that the term does not

25 include any such biological agent or toxin that is in
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1 its naturally occurring environment, if the biological

2 agent or toxin has not been cultivated, collected, or

3 otherwise extracted from its natural source;

4 ‘‘(7) the term ‘registered entity’ means a reg5 istered facility, or a certified laboratory exempted

6 from registration, pursuant to the regulations pro7 mulgated by the Secretary of Health and Human

8 Services under section 511(f) of the Antiterrorism

9 and Effective Death Penalty Act of 1996 (42 C.F.R.

10 72.6(a), 72.6(h));

11 ‘‘(8) the term ‘restricted individual’ means an

12 individual who—

13 ‘‘(A) is under indictment for a crime pun14 ishable by imprisonment for a term exceeding 1

15 year;

16 ‘‘(B) has been convicted in any court of a

17 crime—

18 ‘‘(i) punishable by imprisonment for a

19 term exceeding 1 year but not more than

20 5 years; or

21 ‘‘(ii) punishable by imprisonment for

22 a term exceeding 5 years;

23 ‘‘(C) is a fugitive from justice;
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1 ‘‘(D) is an unlawful user of any controlled

2 substance (as defined in section 102 of the Con3 trolled Substances Act (21 U.S.C. 802));

4 ‘‘(E) is an alien illegally or unlawfully in

5 the United States;

6 ‘‘(F) is an alien (other than an alien law7 fully admitted for permanent residence) who is

8 a national of a country as to which the Sec9 retary of State, pursuant to section 6(j) of the

10 Export Administration Act of 1979 (50 U.S.C.

11 App. 2405(j)) (or its successor law), section

12 620A of the Foreign Assistance Act of 1961

13 (22 U.S.C. 2371), or section 40(d) of the Arms

14 Export Control Act (22 U.S.C. 2780(d)), has

15 made a determination, which remains in effect,

16 that such country has repeatedly provided sup17 port for acts of international terrorism; or

18 ‘‘(G) has been discharged from the Armed

19 Forces of the United States under dishonorable

20 conditions;

21 ‘‘(9) the term ‘alien’ has the same meaning as

22 in section 101(a)(3) of the Immigration and Nation23 ality Act (8 U.S.C. 1101(a)(3));

24 ‘‘(10) the term ‘lawfully admitted for perma25 nent residence’ has the same meaning as in section
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1 101(a)(20) of the Immigration and Nationality Act

2 (8 U.S.C. 1101(a)(20));

3 ‘‘(11) the term ‘designated agency’ means—

4 ‘‘(A) except as provided in subparagraphs

5 (B) and (C) of this paragraph, the agency des6 ignated by the President under section

7 2(b)(3)(A)(i) of the Dangerous Biological Agent

8 and Toxin Control Act of 2000’’;

9 ‘‘(B) for purposes of section 175(e)(6)(E)

10 of this title, the agency designated by the Presi11 dent under section 2(b)(3)(A)(ii) of the Dan12 gerous Biological Agent and Toxin Control Act

13 of 2000; and

14 ‘‘(C) for purposes of section 175(f) of this

15 title, the agency designated by the President

16 under section 2(b)(3)(A)(iii) of the Dangerous

17 Biological Agent and Toxin Control Act of

18 2000; and

19 ‘‘(12) the term ‘State’ includes a State of the

20 United States, the District of Columbia, and any

21 commonwealth, territory, or possession of the United

22 States, including any political subdivision thereof.’’.

23 (2) SECTION 2332a.—Section 2332a of title 18,

24 United States Code, is amended—
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1 (A) in subsection (a), by striking ‘‘, includ2 ing any biological agent, toxin, or vector (as

3 those terms are defined in section 178)’’; and

4 (B) in subsection (c)(2)(C), by striking ‘‘a

5 disease organism’’ and inserting ‘‘any biological

6 agent, toxin, or vector (as those terms are de7 fined in section 178 of this title)’’.

Æ