Protection against intentional adulteration
Determinations
In general
The Secretary shall—
conduct a vulnerability assessment of the food system, including by consideration of the Department of Homeland Security biological, chemical, radiological, or other terrorism risk assessments;
consider the best available understanding of uncertainties, risks, costs, and benefits associated with guarding against intentional adulteration of food at vulnerable points; and
determine the types of science-based mitigation strategies or measures that are necessary to protect against the intentional adulteration of food.
Limited distribution
Regulations
Not later than 18 months after
specify how a person shall assess whether the person is required to implement mitigation strategies or measures intended to protect against the intentional adulteration of food; and
specify appropriate science-based mitigation strategies or measures to prepare and protect the food supply chain at specific vulnerable points, as appropriate.
Applicability
Regulations promulgated under subsection (b) shall apply only to food for which there is a high risk of intentional contamination, as determined by the Secretary, in consultation with the Secretary of Homeland Security, under subsection (a), that could cause serious adverse health consequences or death to humans or animals and shall include those foods—
for which the Secretary has identified clear vulnerabilities (including short shelf-life or susceptibility to intentional contamination at critical control points); and
in bulk or batch form, prior to being packaged for the final consumer.
Exception
Definition
Source
(June 25, 1938, ch. 675, § 420, as added Pub. L. 111–353, title I, § 106(a),Notes
Statutory Notes and Related Subsidiaries
Construction
Guidance Documents
In general.—
Not later than 1 year after the date of enactment of this Act [
Content.—
The guidance documents issued under paragraph (1) shall—
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);
include examples of mitigation strategies or measures described in subsection (b)(2) of such section; and
specify situations in which the examples of mitigation strategies or measures described in subsection (b)(2) of such section are appropriate.
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.”