of any sort remains high. Based on information from 
the FDA and manufacturers, the PHS projects that 
the United States will complete its transition to a 
secure routine pediatric vaccine supply free of thi-
merosal as a preservative (i.e. at least two vaccine 
products each for Hep B, Hib, and DTaP) by the 
first quarter of 2001.’’. 
(3) The Institute of Medicine’s Immunization 
Review Committee concluded that significant reasons 
existed for continued public health attention to con-
cerns 
about 
thimerosal 
exposure 
and 
neurodevelopmental disorders and recommended the 
removal of thimerosal from vaccines administered to 
children and pregnant women. 
(4) Federal regulatory agencies and manufac-
turers have taken positive steps to remove thimer-
osal from some medical products, most notably rou-
tinely administered childhood vaccines. 
(5) Considerable progress has been made in re-
ducing mercury exposures from childhood vaccines, 
yet 5 years after the July 1999 statement, thimer-
osal remains in several nonroutinely administered 
childhood vaccines. 
(6) There is no law or regulation to prohibit the 
reintroduction of thimerosal into any products from
which it has been removed, leaving open the possi-
bility that it may be reintroduced at some point in 
the future. 
(7) The Environmental Protection Agency has 
estimated that as many as 1 in 6 infants are born 
with a blood mercury level that exceeds the Agency’s 
safety threshold. 
(8) Cumulative exposures to mercury, a 
neurotoxin, are known to cause harm, particularly in 
young children and pregnant women. 
(9) Taking steps to reduce mercury exposures 
through vaccines is an important way to reduce di-
rect exposures to mercury and mercury compounds. 
SEC. 3. BANNED MERCURY-CONTAINING VACCINES. 
(a) PROHIBITION.—Section 501 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351) is amended by 
adding at the end the following: 
‘‘(h) If it is a banned mercury-containing vaccine 
under section 351B of the Public Health Service Act.’’. 
(b) AMENDMENT TO PHSA.—Title III of the Public 
Health Service Act (42 U.S.C. 241 et seq.) is amended 
by inserting after section 351A the following: 
‘‘SEC. 351B. BANNED MERCURY-CONTAINING VACCINES. 
‘‘(a) IN GENERAL.—For purposes of section 501(h) 
of the Federal Food, Drug, and Cosmetic Act, and subject
to subsection (b), a vaccine is a banned mercury-con-
taining vaccine under this section if— 
‘‘(1) 1 dose of the vaccine contains 1 or more 
micrograms of mercury in any form; or 
‘‘(2) the vaccine contains any quantity of thi-
merosal and is listed in the current version of the 
recommended childhood and adolescent immuniza-
tion schedule of the Centers for Disease Control and 
Prevention. 
‘‘(b) PUBLIC HEALTH EMERGENCY EXCEPTION.— 
‘‘(1) EXCEPTION.—Subsection (h) of section 
501 of the Federal Food, Drug, and Cosmetic Act 
shall not apply to a vaccine during the effective pe-
riod of a declaration issued by the Secretary for 
such vaccine under this section. 
‘‘(2) DECLARATION.—The Secretary may issue 
a declaration concluding that an actual or potential 
bioterrorist incident or other actual or potential pub-
lic health emergency makes advisable the adminis-
tration of a vaccine described in subsection (a) not-
withstanding the mercury or thimerosal content of 
such vaccine. 
‘‘(3) LIMITATION.—The Secretary—
‘‘(A) shall specify in any declaration under 
this section the beginning and ending dates of 
the effective period of the declaration; and 
‘‘(B) may not specify any such effective pe-
riod that exceeds 12 months. 
‘‘(4) RENEWALS.—At the end of the effective 
period of any declaration under this section, the Sec-
retary, subject to paragraph (3), may issue another 
declaration for the same incident or public health 
emergency. 
‘‘(5) 
PUBLICATION.—The 
Secretary 
shall 
promptly publish each declaration under this section 
in the Federal Register. 
‘‘(c) EFFECTIVE DATES.— 
‘‘(1) MERCURY-CONTAINING VACCINES.—In the 
case of a vaccine described in subsection (a)(1), the 
amendments made by this section apply only to vac-
cines introduced, or delivered for introduction, into 
interstate commerce on or after the following: 
‘‘(A) July 1, 2004, if the vaccine is an in-
fluenza vaccine. 
‘‘(B) January 1, 2005, if the vaccine 
(other than an influenza vaccine) is listed in the 
January–June 
2004 
version 
of 
the 
rec-
ommended childhood and adolescent immuniza-
tion schedule of the Centers for Disease Control 
and Prevention. 
‘‘(C) January 1, 2006, in the case of any 
vaccine not described in subparagraph (A) or 
(B). 
‘‘(2) THIMEROSAL-CONTAINING VACCINES.—In 
the case of a vaccine that is not described in sub-
section (a)(1), but is described in subsection (a)(2), 
the amendments made by this section apply only to 
vaccines introduced, or delivered for introduction, 
into interstate commerce on or after January 1, 
2007.’’. 
SEC. 4. INFORMATION ON THIMEROSAL CONTENT. 
Section 2126 of the Public Health Service Act (42 
U.S.C. 300aa–26) is amended by adding at the end the 
following: 
‘‘(e) THIMEROSAL CONTENT.—Not later than 2 
months after the date of the enactment of this subsection, 
the Secretary shall revise the vaccine information mate-
rials developed and disseminated under this section to en-
sure that, in the case of any vaccine described in sub-
section (a) that contains thimerosal, the materials in-
clude— 
‘‘(1) a statement indicating the presence of thi-
merosal in the vaccine;