Statutory Notes and Related Subsidiaries

Construction

Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

Guidance Documents

Pub. L. 111–353, title I, § 106(b), Jan. 4, 2011, 124 Stat. 3906, provided that:

“(1)

In general.—

Not later than 1 year after the date of enactment of this Act [Jan. 4, 2011], the Secretary of Health and Human Services, in consultation with the Secretary of Homeland Security and the Secretary of Agriculture, shall issue guidance documents related to protection against the intentional adulteration of food, including mitigation strategies or measures to guard against such adulteration as required under section 420 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 450i], as added by subsection (a).

“(2)

Content.—

The guidance documents issued under paragraph (1) shall—

“(A)

include a model assessment for a person to use under subsection (b)(1) of section 420 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a);

“(B)

include examples of mitigation strategies or measures described in subsection (b)(2) of such section; and

“(C)

specify situations in which the examples of mitigation strategies or measures described in subsection (b)(2) of such section are appropriate.

“(3)

Limited distribution.—

In the interest of national security, the Secretary of Health and Human Services, in consultation with the Secretary of Homeland Security, may determine the time, manner, and form in which the guidance documents issued under paragraph (1) are made public, including by releasing such documents to targeted audiences.”

Periodic Review

Pub. L. 111–353, title I, § 106(c), Jan. 4, 2011, 124 Stat. 3906, provided that: “The Secretary of Health and Human Services shall periodically review and, as appropriate, update the regulations under section 420(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 450i(b)], as added by subsection (a), and the guidance documents under subsection (b) [section 106(b) of Pub. L. 111–353, set out above].”