-CITE-

7 USC CHAPTER 110 - ENHANCING CONTROLS ON DANGEROUS

BIOLOGICAL AGENTS AND TOXINS 01/06/03

-EXPCITE-

TITLE 7 - AGRICULTURE

CHAPTER 110 - ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND

TOXINS

.

-HEAD-

CHAPTER 110 - ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND

TOXINS

-MISC1-

SUBCHAPTER I - DEPARTMENT OF AGRICULTURE

Sec.

8401. Regulation of certain biological agents and toxins.

(a) Regulatory control of certain biological agents

and toxins.

(b) Regulation of transfers of listed agents and

toxins.

(c) Possession and use of listed agents and toxins.

(d) Registration; identification; database.

(e) Safeguard and security requirements for

registered persons.

(f) Inspections.

(g) Exemptions.

(h) Disclosure of information.

(i) Civil money penalty.

(j) Notification in event of release.

(k) Reports.

(l) Definitions.

(m) Authorization of appropriations.

SUBCHAPTER II - INTERAGENCY COORDINATION REGARDING OVERLAP AGENTS

AND TOXINS

8411. Interagency coordination.

(a) In general.

(b) Certain matters.

(c) Memorandum of understanding.

(d) Joint regulations.

-CITE-

7 USC SUBCHAPTER I - DEPARTMENT OF AGRICULTURE 01/06/03

-EXPCITE-

TITLE 7 - AGRICULTURE

CHAPTER 110 - ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND

TOXINS

SUBCHAPTER I - DEPARTMENT OF AGRICULTURE

.

-HEAD-

SUBCHAPTER I - DEPARTMENT OF AGRICULTURE

-CITE-

7 USC Sec. 8401 01/06/03

-EXPCITE-

TITLE 7 - AGRICULTURE

CHAPTER 110 - ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND

TOXINS

SUBCHAPTER I - DEPARTMENT OF AGRICULTURE

-HEAD-

Sec. 8401. Regulation of certain biological agents and toxins

-STATUTE-

(a) Regulatory control of certain biological agents and toxins

(1) List of biological agents and toxins

(A) In general

The Secretary of Agriculture shall by regulation establish

and maintain a list of each biological agent and each toxin

that the Secretary determines has the potential to pose a

severe threat to animal or plant health, or to animal or plant

products.

(B) Criteria

In determining whether to include an agent or toxin on the

list under subparagraph (A), the Secretary shall -

(i) consider -

(I) the effect of exposure to the agent or toxin on

animal or plant health, and on the production and

marketability of animal or plant products;

(II) the pathogenicity of the agent or the toxicity of

the toxin and the methods by which the agent or toxin is

transferred to animals or plants;

(III) the availability and effectiveness of

pharmacotherapies and prophylaxis to treat and prevent any

illness caused by the agent or toxin; and

(IV) any other criteria that the Secretary considers

appropriate to protect animal or plant health, or animal or

plant products; and

(ii) consult with appropriate Federal departments and

agencies and with scientific experts representing appropriate

professional groups.

(2) Biennial review

The Secretary shall review and republish the list under

paragraph (1) biennially, or more often as needed, and shall by

regulation revise the list as necessary in accordance with such

paragraph.

(b) Regulation of transfers of listed agents and toxins

The Secretary shall by regulation provide for -

(1) the establishment and enforcement of safety procedures for

the transfer of listed agents and toxins, including measures to

ensure -

(A) proper training and appropriate skills to handle such

agents and toxins; and

(B) proper laboratory facilities to contain and dispose of

such agents and toxins;

(2) the establishment and enforcement of safeguard and security

measures to prevent access to such agents and toxins for use in

domestic or international terrorism or for any other criminal

purpose;

(3) the establishment of procedures to protect animal and plant

health, and animal and plant products, in the event of a transfer

or potential transfer of such an agent or toxin in violation of

the safety procedures established under paragraph (1) or the

safeguard and security measures established under paragraph (2);

and

(4) appropriate availability of biological agents and toxins

for research, education, and other legitimate purposes.

(c) Possession and use of listed agents and toxins

The Secretary shall by regulation provide for the establishment

and enforcement of standards and procedures governing the

possession and use of listed agents and toxins, including the

provisions described in paragraphs (1) through (4) of subsection

(b) of this section, in order to protect animal and plant health,

and animal and plant products.

(d) Registration; identification; database

(1) Registration

Regulations under subsections (b) and (c) of this section shall

require registration with the Secretary of the possession, use,

and transfer of listed agents and toxins, and shall include

provisions to ensure that persons seeking to register under such

regulations have a lawful purpose to possess, use, or transfer

such agents and toxins, including provisions in accordance with

subsection (e)(6) of this section.

(2) Identification; database

Regulations under subsections (b) and (c) of this section shall

require that registration include (if available to the person

registering) information regarding the characterization of listed

agents and toxins to facilitate their identification, including

their source. The Secretary shall maintain a national database

that includes the names and locations of registered persons, the

listed agents and toxins such persons are possessing, using, or

transferring, and information regarding the characterization of

such agents and toxins.

(e) Safeguard and security requirements for registered persons

(1) In general

Regulations under subsections (b) and (c) of this section shall

include appropriate safeguard and security requirements for

persons possessing, using, or transferring a listed agent or

toxin commensurate with the risk such agent or toxin poses to

animal and plant health, and animal and plant products (including

the risk of use in domestic or international terrorism). The

Secretary shall establish such requirements in collaboration with

the Secretary of Homeland Security and the Attorney General, and

shall ensure compliance with such requirements as part of the

registration system under such regulations.

(2) Limiting access to listed agents and toxins

Requirements under paragraph (1) shall include provisions to

ensure that registered persons -

(A) provide access to listed agents and toxins to only those

individuals whom the registered person involved determines have

a legitimate need to handle or use such agents and toxins;

(B) submit the names and other identifying information for

such individuals to the Secretary and the Attorney General,

promptly after first determining that the individuals need

access under subparagraph (A), and periodically thereafter

while the individuals have such access, not less frequently

than once every five years; and

(C)(i) in the case of listed agents and toxins that are not

overlap agents and toxins (as defined in subsection

(g)(1)(A)(ii) of this section), limit or deny access to such

agents and toxins by individuals whom the Attorney General has

identified as within any category under paragraph (3)(B), if

limiting or denying such access by the individuals involved is

determined appropriate by the Secretary, in consultation with

the Attorney General; and

(ii) in the case of listed agents and toxins that are overlap

agents -

(I) deny access to such agents and toxins by individuals

whom the Attorney General has identified as within any

category referred to in paragraph (3)(B)(i); and

(II) limit or deny access to such agents and toxins by

individuals whom the Attorney General has identified as

within any category under paragraph (3)(B)(ii), if limiting

or denying such access by the individuals involved is

determined appropriate by the Secretary, in consultation with

the Attorney General.

(3) Submitted names; use of databases by Attorney General

(A) In general

Upon the receipt of names and other identifying information

under paragraph (2)(B), the Attorney General shall, for the

sole purpose of identifying whether the individuals involved

are within any of the categories specified in subparagraph (B),

promptly use criminal, immigration, national security, and

other electronic databases that are available to the Federal

Government and are appropriate for such purpose.

(B) Certain individuals

For purposes of subparagraph (A), the categories specified in

this subparagraph regarding an individual are that -

(i) the individual is within any of the categories

described in section 175b(d)(1) of title 18 (relating to

restricted persons); or

(ii) the individual is reasonably suspected by any Federal

law enforcement or intelligence agency of -

(I) committing a crime set forth in section 2332b(g)(5)

of title 18;

(II) knowing involvement with an organization that

engages in domestic or international terrorism (as defined

in section 2331 of such title 18) or with any other

organization that engages in intentional crimes of

violence; or

(III) being an agent of a foreign power (as defined in

section 1801 of title 50).

(C) Notification by Attorney General regarding submitted names

After the receipt of a name and other identifying information

under paragraph (2)(B), the Attorney General shall promptly

notify the Secretary whether the individual is within any of

the categories specified in subparagraph (B).

(4) Notifications by Secretary

The Secretary, after receiving notice under paragraph (3)

regarding an individual, shall promptly notify the registered

person involved of whether the individual is granted or denied

access under paragraph (2). If the individual is denied such

access, the Secretary shall promptly notify the individual of the

denial.

(5) Expedited review

Regulations under subsections (b) and (c) of this section shall

provide for a procedure through which, upon request to the

Secretary by a registered person who submits names and other

identifying information under paragraph (2)(B) and who

demonstrates good cause, the Secretary may, as determined

appropriate by the Secretary -

(A) request the Attorney General to expedite the process of

identification under paragraph (3)(A) and notification of the

Secretary under paragraph (3)(C); and

(B) expedite the notification of the registered person by the

Secretary under paragraph (4).

(6) Process regarding persons seeking to register

(A) Individuals

Regulations under subsections (b) and (c) of this section

shall provide that an individual who seeks to register under

either of such subsections is subject to the same processes

described in paragraphs (2) through (4) as apply to names and

other identifying information submitted to the Attorney General

under paragraph (2)(B). Paragraph (5) does not apply for

purposes of this subparagraph.

(B) Other persons

Regulations under subsections (b) and (c) of this section

shall provide that, in determining whether to deny or revoke

registration by a person other than an individual, the

Secretary shall submit the name of such person to the Attorney

General, who shall use criminal, immigration, national

security, and other electronic databases available to the

Federal Government, as appropriate for the purpose of promptly

notifying the Secretary whether the person, or, where relevant,

the individual who owns or controls such person, is within any

of the categories described in section 175b(d)(1) of title 18

(relating to restricted persons), or is reasonably suspected by

any Federal law enforcement or intelligence agency of being

within any category specified in paragraph (3)(B)(ii) (as

applied to persons, including individuals). Such regulations

shall provide that a person who seeks to register under either

of such subsections is subject to the same processes described

in paragraphs (2) and (4) as apply to names and other

identifying information submitted to the Attorney General under

paragraph (2)(B). Paragraph (5) does not apply for purposes of

this subparagraph. The Secretary may exempt Federal, State, or

local governmental agencies from the requirements of this

subparagraph.

(7) Review

(A) Administrative review

(i) In general

Regulations under subsections (b) and (c) of this section

shall provide for an opportunity for a review by the

Secretary -

(I) when requested by the individual involved, of a

determination under paragraph (2) to deny the individual

access to listed agents and toxins; and

(II) when requested by the person involved, of a

determination under under (FOOTNOTE 1) paragraph (6) to

deny or revoke registration for such person.

(FOOTNOTE 1) So in original.

(ii) Ex parte review

During a review under clause (i), the Secretary may

consider information relevant to the review ex parte to the

extent that disclosure of the information could compromise

national security or an investigation by any law enforcement

agency.

(iii) Final agency action

The decision of the Secretary in a review under clause (i)

constitutes final agency action for purposes of section 702

of title 5.

(B) Certain procedures

(i) Submission of ex parte materials in judicial proceedings

When reviewing a decision of the Secretary under

subparagraph (A), and upon request made ex parte and in

writing by the United States, a court, upon a sufficient

showing, may review and consider ex parte documents

containing information the disclosure of which could

compromise national security or an investigation by any law

enforcement agency. If the court determines that portions of

the documents considered ex parte should be disclosed to the

person involved to allow a response, the court shall

authorize the United States to delete from such documents

specified items of information the disclosure of which could

compromise national security or an investigation by any law

enforcement agency, or to substitute a summary of the

information to which the person may respond. Any order by

the court authorizing the disclosure of information that the

United States believes could compromise national security or

an investigation by any law enforcement agency shall be

subject to the processes set forth in subparagraphs (A) and

(B)(i) of section 2339B(f)(5) of title 18 (relating to

interlocutory appeal and expedited consideration).

(ii) Disclosure of information

In a review under subparagraph (A), and in any judical

(FOOTNOTE 2) proceeding conducted pursuant to such review,

neither the Secretary nor the Attorney General may be

required to disclose to the public any information that under

subsection (h) of this section shall not be disclosed under

section 552 of title 5.

(FOOTNOTE 2) So in original. Probably should be ''judicial''.

(8) Notifications regarding theft or loss of agents

Requirements under paragraph (1) shall include the prompt

notification of the Secretary, and appropriate Federal, State,

and local law enforcement agencies, of the theft or loss of

listed agents and toxins.

(9) Technical assistance for registered persons

The Secretary, in consultation with the Attorney General, may

provide technical assistance to registered persons to improve

security of the facilities of such persons.

(f) Inspections

The Secretary shall have the authority to inspect persons subject

to regulations under subsection (b) or (c) of this section to

ensure their compliance with such regulations, including

prohibitions on restricted persons and other provisions of

subsection (e) of this section.

(g) Exemptions

(1) Overlap agents and toxins

(A) In general

(i) Limitation

In the case of overlap agents and toxins, exemptions from

the applicability of provisions of regulations under

subsection (b) or (c) of this section may be granted only to

the extent provided in this paragraph.

(ii) Definitions

For purposes of this section:

(I) The term ''overlap agents and toxins'' means

biological agents and toxins that -

(aa) are listed pursuant to subsection (a)(1) of this

section; and

(bb) are listed pursuant to section 262a(a)(1) of title

42. (FOOTNOTE 3)

(FOOTNOTE 3) See References in Text note below.

(II) The term ''overlap agent or toxin'' means a

biological agent or toxin that -

(aa) is listed pursuant to subsection (a)(1) of this

section; and

(bb) is listed pursuant to section 262a(a)(1) of title

42. (FOOTNOTE 3)

(B) Clinical or diagnostic laboratories

Regulations under subsections (b) and (c) of this section

shall exempt clinical or diagnostic laboratories and other

persons who possess, use, or transfer overlap agents or toxins

that are contained in specimens presented for diagnosis,

verification, or proficiency testing, provided that -

(i) the identification of such agents or toxins is reported

to the Secretary, and when required under Federal, State, or

local law, to other appropriate authorities; and

(ii) such agents or toxins are transferred or destroyed in

a manner set forth by the Secretary by regulation.

(C) Products

(i) In general

Regulations under subsections (b) and (c) of this section

shall exempt products that are, bear, or contain overlap

agents or toxins and are cleared, approved, licensed, or

registered under any of the Acts specified in clause (ii),

unless the Secretary by order determines that applying

additional regulation under subsection (b) or (c) of this

section to a specific product is necessary to protect animal

or plant health, or animal or plant products.

(ii) Relevant laws

For purposes of clause (i), the Acts specified in this

clause are the following:

(I) The Federal Food, Drug, and Cosmetic Act (21 U.S.C.

301 et seq.).

(II) Section 351 of the Public Health Service Act (42

U.S.C. 262).

(III) The Act commonly known as the Virus-Serum-Toxin Act

(the eighth paragraph under the heading ''Bureau of Animal

Industry'' in the Act of March 4, 1913; 21 U.S.C. 151-159).

(IV) The Federal Insecticide, Fungicide, and Rodenticide

Act (7 U.S.C. 136 et seq.).

(iii) Investigational use

(I) In general

The Secretary may exempt an investigational product that

is, bears, or contains an overlap agent or toxin from the

applicability of provisions of regulations under subsection

(b) or (c) of this section when such product is being used

in an investigation authorized under any Federal Act and

the Secretary determines that applying additional

regulation under subsection (b) or (c) of this section to

such product is not necessary to protect animal and plant

health, and animal and plant products.

(II) Certain processes

Regulations under subsections (b) and (c) of this section

shall set forth the procedures for applying for an

exemption under subclause (I). In the case of

investigational products authorized under any of the Acts

specified in clause (ii), the Secretary shall make a

determination regarding a request for an exemption not

later than 14 days after the first date on which both of

the following conditions have been met by the person

requesting the exemption:

(aa) The person has submitted to the Secretary an

application for the exemption meeting the requirements

established by the Secretary.

(bb) The person has notified the Secretary that the

investigation has been authorized under such an Act.

(D) Agricultural emergencies

The Secretary may temporarily exempt a person from the

applicability of the requirements of this section with respect

to an overlap agent or toxin, in whole or in part, if the

Secretary determines that such exemption is necessary to

provide for the timely participation of the person in a

response to a domestic or foreign agricultural emergency that

involves such an agent or toxin. With respect to the emergency

involved, the exemption under this subparagraph for a person

may not exceed 30 days, except that the Secretary, after review

of whether such exemption remains necessary, may provide one

extension of an additional 30 days.

(E) Public health emergencies

Upon request of the Secretary of Health and Human Services,

after the granting by such Secretary of an exemption under

262a(g)(3) (FOOTNOTE 4) of title 42 pursuant to a finding that

there is a public health emergency, the Secretary of

Agriculture may temporarily exempt a person from the

applicability of the requirements of this section with respect

to an overlap agent or toxin, in whole or in part, to provide

for the timely participation of the person in a response to the

public health emergency. With respect to the emergency

involved, such exemption for a person may not exceed 30 days,

except that upon request of the Secretary of Health and Human

Services, the Secretary of Agriculture may, after review of

whether such exemption remains necessary, provide one extension

of an additional 30 days.

(FOOTNOTE 4) So in original. Probably should be preceded by

''section''.

(2) General authority for exemptions not involving overlap agents

or toxins

In the case of listed agents or toxins that are not overlap

agents or toxins, the Secretary may grant exemptions from the

applicability of provisions of regulations under subsection (b)

or (c) of this section if the Secretary determines that such

exemptions are consistent with protecting animal and plant

health, and animal and plant products.

(h) Disclosure of information

(1) Nondisclosure of certain information

No Federal agency specified in paragraph (2) shall disclose

under section 552 of title 5 any of the following:

(A) Any registration or transfer documentation submitted

under subsections (b) and (c) of this section, or permits

issued prior to June 12, 2002, for the possession, use or

transfer of a listed agent or toxin; or information derived

therefrom to the extent that it identifies the listed agent or

toxin possessed, used or transferred by a specific person or

discloses the identity or location of a specific person.

(B) The national database developed pursuant to subsection

(d) of this section, or any other compilation of the

registration or transfer information submitted under

subsections (b) and (c) of this section to the extent that such

compilation discloses site-specific registration or transfer

information.

(C) Any portion of a record that discloses the site-specific

or transfer-specific safeguard and security measures used by a

registered person to prevent unauthorized access to listed

agents and toxins.

(D) Any notification of a release of a listed agent or toxin

submitted under subsections (b) and (c) of this section, or any

notification of theft or loss submitted under such subsections.

(E) Any portion of an evaluation or report of an inspection

of a specific registered person conducted under subsection (f)

of this section that identifies the listed agent or toxin

possessed by a specific registered person or that discloses the

identity or location of a specific registered person if the

agency determines that public disclosure of the information

would endanger animal or plant health, or animal or plant

products.

(2) Covered agencies

For purposes of paragraph (1) only, the Federal agencies

specified in this paragraph are the following:

(A) The Department of Health and Human Services, the

Department of Justice, the Department of Agriculture, and the

Department of Transportation.

(B) Any Federal agency to which information specified in

paragraph (1) is transferred by any agency specified in

subparagraph (A) of this paragraph.

(C) Any Federal agency that is a registered person, or has a

sub-agency component that is a registered person.

(D) Any Federal agency that awards grants or enters into

contracts or cooperative agreements involving listed agents and

toxins to or with a registered person, and to which information

specified in paragraph (1) is transferred by any such

registered person.

(3) Other exemptions

This subsection may not be construed as altering the

application of any exemptions to public disclosure under section

552 of title 5, except as to subsection (FOOTNOTE 5) 552(b)(3) of

such title, to any of the information specified in paragraph (1).

(FOOTNOTE 5) So in original. Probably should be ''section''.

(4) Rule of construction

Except as specifically provided in paragraph (1), this

subsection may not be construed as altering the authority of any

Federal agency to withhold under section 552 of title 5, or the

obligation of any Federal agency to disclose under section 552 of

title 5, any information, including information relating to -

(A) listed agents and toxins, or individuals seeking access

to such agents and toxins;

(B) registered persons, or persons seeking to register their

possession, use, or transfer of such agents and toxins;

(C) general safeguard and security policies and requirements

under regulations under subsections (b) and (c) of this

section; or

(D) summary or statistical information concerning

registrations, registrants, denials or revocations of

registrations, listed agents and toxins, inspection evaluations

and reports, or individuals seeking access to such agents and

toxins.

(5) Disclosures to Congress; other disclosures

This subsection may not be construed as providing any authority

-

(A) to withhold information from the Congress or any

committee or subcommittee thereof; or

(B) to withhold information from any person under any other

Federal law or treaty.

(i) Civil money penalty

(1) In general

In addition to any other penalties that may apply under law,

any person who violates any provision of regulations under

subsection (b) or (c) of this section shall be subject to the

United States for a civil money penalty in an amount not

exceeding $250,000 in the case of an individual and $500,000 in

the case of any other person.

(2) Applicability of certain provisions

The provisions of sections 423 and 425(2) of the Plant

Protection Act (7 U.S.C. 7733 and 7735(2)) shall apply to a civil

money penalty or activity under paragraph (1) in the same manner

as such provisions apply to a penalty or activity under the Plant

Protection Act (7 U.S.C. 7701 et seq.).

(j) Notification in event of release

Regulations under subsections (b) and (c) of this section shall

require the prompt notification of the Secretary by a registered

person whenever a release, meeting criteria established by the

Secretary, of a listed agent or toxin has occurred outside of the

biocontainment area of a facility of the registered person. Upon

receipt of such notification and a finding by the Secretary that

the release poses a threat to animal or plant health, or animal or

plant products, the Secretary shall take appropriate action to

notify relevant Federal, State, and local authorities, and, if

necessary, other appropriate persons (including the public). If

the released listed agent or toxin is an overlap agent or toxin,

the Secretary shall promptly notify the Secretary of Health and

Human Services upon notification by the registered person.

(k) Reports

The Secretary shall report to the Congress annually on the number

and nature of notifications received under subsection (e)(8) of

this section (relating to theft or loss) and subsection (j) of this

section (relating to releases).

(l) Definitions

For purposes of this section:

(1) The terms ''biological agent'' and ''toxin'' have the

meanings given such terms in section 178 of title 18.

(2) The term ''listed agents and toxins'' means biological

agents and toxins listed pursuant to subsection (a)(1) of this

section.

(3) The term ''listed agents or toxins'' means biological

agents or toxins listed pursuant to subsection (a)(1) of this

section.

(4) The terms ''overlap agents and toxins'' and ''overlap agent

or toxin'' have the meaning given such terms in subsection

(g)(1)(A)(ii) of this section.

(5) The term ''person'' includes Federal, State, and local

governmental entities.

(6) The term ''registered person'' means a person registered

under regulations under subsection (b) or (c) of this section.

(7) The term ''Secretary'' means the Secretary of Agriculture.

(m) Authorization of appropriations

For the purpose of carrying out this section, there are

authorized to be appropriated such sums as may be necessary for

each of the fiscal years 2002 through 2007, in addition to other

funds that may be available.

-SOURCE-

(Pub. L. 107-188, title II, Sec. 212, June 12, 2002, 116 Stat. 647;

Pub. L. 107-296, title XVII, Sec. 1709(b), Nov. 25, 2002, 116 Stat.

2319.)

-REFTEXT-

REFERENCES IN TEXT

Section 262a(a)(1) of title 42, referred to in subsec.

(g)(1)(A)(ii), was in the original ''section 315A(a)(1) of the

Public Health Service Act'', and was translated as meaning section

351A(a)(1) of that Act to reflect the probable intent of Congress,

because the Public Health Service Act does not contain a section

315A and section 351A refers to a list of biological agents and

toxins.

The Federal Food, Drug, and Cosmetic Act, referred to in subsec.

(g)(1)(C)(ii)(I), is act June 25, 1938, ch. 675, 52 Stat. 1040, as

amended, which is classified generally to chapter 9 (Sec. 301 et

seq.) of Title 21, Food and Drugs. For complete classification of

this Act to the Code, see section 301 of Title 21 and Tables.

The Act commonly known as the Virus-Serum-Toxin Act, referred to

in subsec. (g)(1)(C)(ii)(III), is the eighth paragraph under the

heading ''Bureau of Animal Industry'' of act Mar. 4, 1913, ch. 145,

37 Stat. 832, as amended, which is classified generally to chapter

5 (Sec. 151 et seq.) of Title 21, Food and Drugs. For complete

classification of this Act to the Code, see Short Title note set

out under section 151 of Title 21 and Tables.

The Federal Insecticide, Fungicide, and Rodenticide Act,

referred to in subsec. (g)(1)(C)(ii)(IV), is act June 25, 1947, ch.

125, as amended generally by Pub. L. 92-516, Oct. 21, 1972, 86

Stat. 973, which is classified generally to subchapter II (Sec. 136

et seq.) of chapter 6 of this title. For complete classification

of this Act to the Code, see Short Title note set out under section

136 of this title and Tables.

The Plant Protection Act, referred to in subsec. (i)(2), is title

IV of Pub. L. 106-224, June 20, 2000, 114 Stat. 438, as amended,

which is classified principally to chapter 104 (Sec. 7701 et seq.)

of this title. For complete classification of this Act to the

Code, see Short Title note set out under section 7701 of this title

and Tables.

-MISC2-

AMENDMENTS

2002 - Subsec. (e)(1). Pub. L. 107-296 substituted

''collaboration with the Secretary of Homeland Security and'' for

''consultation with''.

EFFECTIVE DATE OF 2002 AMENDMENT

Amendment by Pub. L. 107-296 effective 60 days after Nov. 25,

2002, see section 4 of Pub. L. 107-296, set out as an Effective

Date note under section 101 of Title 6, Domestic Security.

SHORT TITLE

Pub. L. 107-188, title II, Sec. 211, June 12, 2002, 116 Stat.

647, provided that: ''This subtitle (subtitle B (Sec. 211-213) of

title II of Pub. L. 107-188, enacting this subchapter) may be cited

as the 'Agricultural Bioterrorism Protection Act of 2002'.''

IMPLEMENTATION BY DEPARTMENT OF AGRICULTURE

Pub. L. 107-188, title II, Sec. 213, June 12, 2002, 116 Stat.

656, provided that:

''(a) Date Certain for Promulgation of List. - Not later than 60

days after the date of the enactment of this Act (June 12, 2002),

the Secretary of Agriculture (referred to in this section as the

'Secretary') shall promulgate an interim final rule that

establishes the initial list under section 212(a)(1) (7 U.S.C.

8401(a)(1)). In promulgating such rule, the Secretary shall provide

written guidance on the manner in which the notice required in

subsection (b) is to be provided to the Secretary.

''(b) Date Certain for Notice of Possession. - Not later than 60

days after the date on which the Secretary promulgates the interim

final rule under subsection (a), all persons (unless exempt under

section 212(g) (7 U.S.C. 8401(g))) in possession of biological

agents or toxins included on the list referred to in subsection (a)

shall notify the Secretary of such possession.

''(c) Date Certain for Promulgation; Effective Date Regarding

Criminal and Civil Penalties. - Not later than 180 days after the

date of the enactment of this Act (June 12, 2002), the Secretary

shall promulgate an interim final rule for carrying out section 212

(7 U.S.C. 8401), other than for the list referred to in subsection

(a) of this section (but such rule may incorporate by reference

provisions promulgated pursuant to subsection (a)). Such interim

final rule shall take effect 60 days after the date on which such

rule is promulgated, including for purposes of -

''(1) section 175b(c) of title 18, United States Code (relating

to criminal penalties), as added by section 231(a)(5) of this

Act; and

''(2) section 212(i) of this Act (7 U.S.C. 8401(i)) (relating

to civil penalties).

''(d) Transitional Provision Regarding Current Research and

Education. - The interim final rule under subsection (c) shall

include time frames for the applicability of the rule that minimize

disruption of research or educational projects that involve

biological agents and toxins listed pursuant to section 212(a)(1)

(7 U.S.C. 8401(a)(1)) and that were underway as of the effective

date of such rule.''

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 8411 of this title; title

6 section 182; title 18 section 175b.

-CITE-

7 USC SUBCHAPTER II - INTERAGENCY COORDINATION REGARDING

OVERLAP AGENTS AND TOXINS 01/06/03

-EXPCITE-

TITLE 7 - AGRICULTURE

CHAPTER 110 - ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND

TOXINS

SUBCHAPTER II - INTERAGENCY COORDINATION REGARDING OVERLAP AGENTS

AND TOXINS

.

-HEAD-

SUBCHAPTER II - INTERAGENCY COORDINATION REGARDING OVERLAP AGENTS

AND TOXINS

-CITE-

7 USC Sec. 8411 01/06/03

-EXPCITE-

TITLE 7 - AGRICULTURE

CHAPTER 110 - ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND

TOXINS

SUBCHAPTER II - INTERAGENCY COORDINATION REGARDING OVERLAP AGENTS

AND TOXINS

-HEAD-

Sec. 8411. Interagency coordination

-STATUTE-

(a) In general

(1) Coordination

The Secretary of Agriculture and the Secretary of Health and

Human Services shall in accordance with this section coordinate

activities regarding overlap agents and toxins.

(2) Overlap agents and toxins; other terms

For purposes of this section:

(A) The term ''overlap agent or toxin'' means a biological

agent or toxin that -

(i) is listed pursuant to section 315A(a)(1) (FOOTNOTE 1)

of the Public Health Service Act (42 U.S.C. 262a(a)(1)), as

added by section 201 of this Act; and

(FOOTNOTE 1) So in original. Probably should be ''351A(a)(1)''.

(ii) is listed pursuant to section 212(a)(1) of this Act (7

U.S.C. 8401(a)(1)).

(B) The term ''section 351A program'' means the program under

section 351A of the Public Health Service Act (42 U.S.C. 262a).

(C) The term ''section 212 program'' means the program under

section 212 of this Act (7 U.S.C. 8401).

(b) Certain matters

In carrying out the section 351A program and the section 212

program, the Secretary of Health and Human Services and the

Secretary of Agriculture shall, to the greatest extent practicable,

coordinate activities to achieve the following purposes:

(1) To minimize any conflicts between the regulations issued

under, and activities carried out under, such programs.

(2) To minimize the administrative burden on persons subject to

regulation under both of such programs.

(3) To ensure the appropriate availability of biological agents

and toxins for legitimate biomedical, agricultural or veterinary

research, education, or other such purposes.

(4) To ensure that registration information for overlap agents

and toxins under the section 351A and section 212 programs is

contained in both the national database under the section 351A

program and the national database under the section 212 program.

(c) Memorandum of understanding

(1) In general

Promptly after June 12, 2002, the Secretary of Agriculture and

the Secretary of Health and Human Services shall enter into a

memorandum of understanding regarding overlap agents and toxins

that is in accordance with paragraphs (2) through (4) and

contains such additional provisions as the Secretary of

Agriculture and the Secretary of Health and Human Services

determine to be appropriate.

(2) Single registration system regarding registered persons

The memorandum of understanding under paragraph (1) shall

provide for the development and implementation of a single system

of registration for persons who possess, use, or transfer overlap

agents or toxins and are required to register under both the

section 351A program and the section 212 program. For purposes

of such system, the memorandum shall provide for the development

and implementation of the following:

(A) A single registration form through which the person

submitting the form provides all information that is required

for registration under the section 351A program and all

information that is required for registration under the section

212 program.

(B) A procedure through which a person may choose to submit

the single registration form to the agency administering the

section 351A program (in the manner provided under such

program), or to the agency administering the section 212

program (in the manner provided under such program).

(C) A procedure through which a copy of a single registration

form received pursuant to subparagraph (B) by the agency

administering one of such programs is promptly provided to the

agency administering the other program.

(D) A procedure through which the agency receiving the single

registration form under one of such programs obtains the

concurrence of the agency administering the other program that

the requirements for registration under the other program have

been met.

(E) A procedure through which -

(i) the agency receiving the single registration form under

one of such programs informs the agency administering the

other program whether the receiving agency has denied the

registration; and

(ii) each of such agencies ensures that registrations are

entered into the national database of registered persons that

is maintained by each such agency.

(3) Process of identification

With respect to the process of identification under the section

351A program and the section 212 program for names and other

identifying information submitted to the Attorney General

(relating to certain categories of individuals and entities), the

memorandum of understanding under paragraph (1) shall provide for

the development and implementation of the following:

(A) A procedure through which a person who is required to

submit information pursuant to such process makes (in addition

to the submission to the Attorney General) a submission, at the

option of the person, to either the agency administering the

section 351A program or the agency administering the section

212 program, but not both, which submission satisfies the

requirement of submission for both of such programs.

(B) A procedure for the sharing by both of such agencies of

information received from the Attorney General by one of such

agencies pursuant to the submission under subparagraph (A).

(C) A procedure through which the agencies administering such

programs concur in determinations that access to overlap agents

and toxins will be granted.

(4) Coordination of inspections and enforcement

The memorandum of understanding under paragraph (1) shall

provide for the development and implementation of procedures

under which Federal personnel under the section 351A program and

the section 212 program may share responsibilities for

inspections and enforcement activities under such programs

regarding overlap agents and toxins. Activities carried out

under such procedures by one of such programs on behalf of the

other may be carried out with or without reimbursement by the

agency that administers the other program.

(5) Date certain for implementation

The memorandum of understanding under paragraph (1) shall be

implemented not later than 180 days after June 12, 2002. Until

the single system of registration under paragraph (2) is

implemented, persons who possess, use, or transfer overlap agents

or toxins shall register under both the section 351A program and

the section 212 program.

(d) Joint regulations

Not later than 18 months after the date on which the single

system of registration under subsection (c)(2) of this section is

implemented, the Secretary of Health and Human Services and the

Secretary of Agriculture shall jointly issue regulations for the

possession, use, and transfer of overlap agents and toxins that

meet the requirements of both the section 351A program and the

section 212 program.

-SOURCE-

(Pub. L. 107-188, title II, Sec. 221, June 12, 2002, 116 Stat.

657.)

-CITE-