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.
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) 1 of the Public Health Service Act [42 U.S.C. 262a(a)(1)], as added by section 201 of this Act; and
(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].
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.
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.
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.
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.
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.
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.
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.
(Pub. L. 107–188, title II, §221, June 12, 2002, 116 Stat. 657.)
Sections: Previous 8316 8317 8318 8320 8321 8322 8401 8411 8501 8502 8503 8504 8505 8506 8507 Next
Last modified: October 26, 2015