Title 7, AgricultureRelease 119-110

§8411 Interagency Coordination

Title 7 › CHAPTER 110 — ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS › SUBCHAPTER II — INTERAGENCY COORDINATION REGARDING OVERLAP AGENTS AND TOXINS › § 8411

Last updated Sep 23, 2026|Official source

Summary

The Secretaries of Agriculture and Health and Human Services must work together on matters about overlap agents and toxins. Overlap agent or toxin: a biological agent or toxin listed in both the HHS section 351A list and the USDA section 212 list. Section 351A program: the HHS program under that law. Section 212 program: the USDA program under that law. The two agencies must coordinate to avoid conflicting rules, cut down paperwork for people regulated by both programs, keep legitimate research and teaching supplies available, and make sure registration data for overlap agents appears in both national databases. Soon after June 12, 2002, the two Secretaries must sign a memorandum of understanding (MOU) that creates a single registration system for people who must register under both programs. The single system must use one form that covers both programs, let someone submit it to either agency, have the receiving agency quickly send a copy to the other agency, get agreement that both programs’ rules are met, report any denial, and put registrations into both national databases. The MOU must also allow an optional single submission of identifying names to one agency (in addition to submission to the Attorney General), require the agencies to share Attorney General responses, let them agree on who may have access to overlap agents, and let them share inspection and enforcement duties (with or without payment). The MOU must be in effect no later than 180 days after June 12, 2002. Until the single system starts, people must register under both programs. Within 18 months after the single system is in place, the two Secretaries must issue joint regulations that meet both programs’ requirements.

Full Legal Text

Title 7, §8411

Agriculture, Source: USLM XML via OLRC

(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)

(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) 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.

Reference

Citations & Metadata

Citation

7 U.S.C. § 8411

Title 7, Agriculture

Last Updated

Sep 23, 2026

Release point: 119-110