S.Amdt. 27

SA 27. Mr. LEE submitted an amendment intended to be proposed by him
to the bill S. 316, to repeal the authorizations for use of military
force against Iraq; which was ordered to lie on the table; as follows:

At the appropriate place, insert the following:

SEC. __. EXEMPTIONS FROM FDA REQUIREMENTS WITH RESPECT TO
INFANT FORMULA.

(a) Waivers.--
(1) In general.--In the case that an infant formula
shortage is established through a joint resolution, with
respect to any infant formula imported into the United States
during the 90-day period beginning on the date specified in
such joint resolution--
(A) the requirements under section 412 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 350a) shall not apply;
(B) such infant formula may be manufactured, processed,
packed, or held in a facility in a country described in
subsection (d) that is not registered under section 415 of
such Act (21 U.S.C. 350d);
(C) the requirements under parts 106 and 107 of title 21,
Code of Federal Regulations, shall not apply; and
(D) such infant formula shall not be considered to be
misbranded or adulterated solely on the basis of not being in
compliance with the requirements of such section 412 or 415,
or such part 106 or 107.
(2) Renewal of waiver period.--A waiver of requirements
under paragraph (1) shall automatically renew for additional
90-day periods until such infant formula shortage is
terminated through a subsequent joint resolution.
(b) Notification Requirement.--
(1) In general.--A person who introduces or delivers for
introduction into interstate commerce an infant formula
pursuant to subsection (a) shall notify the Secretary if such
person has knowledge which reasonably supports the conclusion
that such infant formula--
(A) may not provide the nutrients required by section
412(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
350a(i)); or
(B) is a product that meets any criterion under section
402(a) of such Act (21 U.S.C. 342(a)), or which otherwise may
be unsafe for infant consumption.
(2) Knowledge defined.--For purposes of paragraph (1), the
term ``knowledge'' as applied to a person subject to such
subparagraph means--
(A) the actual knowledge that the person had; or
(B) the knowledge which a reasonable person would have had
under like circumstances or which would have been obtained
upon the exercise of due care.
(c) Recall Authority.--If the Secretary determines that
infant formula introduced or delivered for introduction into
interstate commerce pursuant to subsection (a) is a product
described in subsection (b)(1)(B), the manufacturer or
importer shall immediately take all actions necessary to
recall shipments of such infant formula from all wholesale
and retail establishments, consistent with recall regulations
and guidelines issued by the Secretary.
(d) Countries Described.--A country described in this
subsection is any of the following:
(1) Australia.
(2) Israel.
(3) Japan.
(4) New Zealand.
(5) Switzerland.
(6) South Africa.
(7) The United Kingdom.
(8) A member country of the European Union.
(9) A member country of the European Economic Area.
(e) Definition.--In this section, the term ``infant
formula'' has the meaning given that term in section 201(z)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321(z)).
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