21 U.S.C. § 399e — Nanotechnology

submitted 14 years ago by Pub. L. 112-144 to r/title-21-FOOD-AND-DRUGS · 360 words · no verdicts yet

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The FDA must grow its scientific knowledge about nanomaterials in products it regulates. It studies their safety, benefits, and effects on the body. The FDA can build databases, train staff, and work with other countries on nanomaterial standards.

(a) In general The Secretary of Health and Human Services must expand scientific knowledge about nanomaterials. This applies to nanomaterials in products the Food and Drug Administration regulates. The Secretary must study their possible toxicity, the possible benefits of new nanotechnology-based treatments, and how these materials interact with and affect living systems. (b) Activities To do this, the Secretary may study existing science and data on how nanomaterials generally interact with living systems, and on specific nanomaterials the FDA is concerned about. The Secretary may work with other federal agencies to build databases and models. These would help identify shared patterns in how classes of nanomaterials behave in living systems. The Secretary may support FDA programs and join outside efforts to better understand what novel nanomaterial properties might cause toxicity, and to improve ways of measuring and detecting nanomaterials. The Secretary may gather, organize, interpret, and share scientific information about how nanomaterials interact with living systems. The Secretary must build scientific expertise on nanomaterials inside the FDA — including field and lab expertise — to monitor how much of these materials shows up in products made in the U.S. or imported. The Secretary must keep FDA staff trained and informed about the newest nanomaterial science, both within each center and across the whole agency. The Secretary may also encourage the FDA to join international and national efforts to set consensus standards for nanomaterials, and may carry out any other activity the Secretary decides fits these goals.

the actual law source: uscode.house.gov ↗public domain

(a) In general

The Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall intensify and expand activities related to enhancing scientific knowledge regarding nanomaterials included or intended for inclusion in products regulated under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or other statutes administered by the Food and Drug Administration, to address issues relevant to the regulation of those products, including the potential toxicology of such nanomaterials, the potential benefit of new therapies derived from nanotechnology, the effects of such nanomaterials on biological systems, and the interaction of such nanomaterials with biological systems.

(b) Activities

In conducting activities related to nanotechnology, the Secretary may—

(1)

assess scientific literature and data on general nanomaterials interactions with biological systems and on specific nanomaterials of concern to the Food and Drug Administration;

(2)

in cooperation with other Federal agencies, develop and organize information using databases and models that will facilitate the identification of generalized principles and characteristics regarding the behavior of classes of nanomaterials with biological systems;

(3)

promote Food and Drug Administration programs and participate in collaborative efforts, to further the understanding of the science of novel properties of nanomaterials that might contribute to toxicity;

(4)

promote and participate in collaborative efforts to further the understanding of measurement and detection methods for nanomaterials;

(5)

collect, synthesize, interpret, and disseminate scientific information and data related to the interactions of nanomaterials with biological systems;

(6)

build scientific expertise on nanomaterials within the Food and Drug Administration, including field and laboratory expertise, for monitoring the production and presence of nanomaterials in domestic and imported products regulated under this Act;

(7)

ensure ongoing training, as well as dissemination of new information within the centers of the Food and Drug Administration, and more broadly across the Food and Drug Administration, to ensure timely, informed consideration of the most current science pertaining to nanomaterials;

(8)

encourage the Food and Drug Administration to participate in international and national consensus standards activities pertaining to nanomaterials; and

(9)

carry out other activities that the Secretary determines are necessary and consistent with the purposes described in paragraphs (1) through (8).

Source credit: (Pub. L. 112–144, title XI, § 1126, July 9, 2012, 126 Stat. 1116.)

history & why it existsrecord from the source credit

2012Enacted · Pub. L. 112-144 · 126 Stat. 1116

A history note hasn’t been published yet. The record shows enactment by Pub. L. 112-144 on 2012-07-09.

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