Destruction of certain refused articles

(a)

In general

Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended by adding at the end the following:

(v)

Destruction of refused articles presenting significant public health concerns

(1)

In general

If the Secretary of Health and Human Services finds that an article that has been refused admission under subsection (a) presents a significant public health concern, the Secretary may issue to the owner or consignee of the article an order to destroy the article, without the opportunity for export. (2)

Deadline; costs

Not later than 90 days after the issuance of an order under paragraph (1), the owner or consignee of the article shall destroy the article. The owner or consignee shall be responsible for the costs of such destruction. (3)

Due process

The Secretary of Health and Human Services shall provide to the owner or consignee of an article subject to an order under paragraph (1) appropriate due process prior to the destruction of the article. Such due process shall be specified in regulations and include notice and an opportunity to appear before the Secretary and introduce testimony on the destruction— (A)in combination with the notice and opportunity to appear and introduce testimony on the refusal of admission of the article under subsection (a); or (B)separately.

(b)

Prohibited acts

Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following:

(jjj)The unauthorized movement, or introduction or delivery for introduction into interstate commerce, including export, of an article that is subject to an order for destruction under section 801(v).

(c)

Applicability

The amendments made by subsections (a) and (b) shall apply to articles beginning on the date that is 30 days after the date on which the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, promulgates final regulations under subsection (d). (d)

Regulations

(1)

Proposed

Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue proposed regulations to implement the amendment made by subsection (a), allowing for notice and comment on such proposed regulations. (2)

Final

Not later than 1 year after the issuance of the proposed regulations under paragraph (1), the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall promulgate final regulations to implement the amendment made by subsection (a).