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# Legislative Bulletin...........................................January 10, 2007

> **Contents:**
>
> **H.R. 3** --- Stem Cell Research Enhancement Act of 2007

H.R. 3 --- Stem Cell Research Enhancement Act of 2007 -- as introduced

(*DeGette, D-CO*)

**[Order of Business]{.underline}:** The bill is scheduled to be
considered on Thursday, January 11, pursuant to H.Res. 6 (Title 5, Sec.
509), a rule that the House passed last week closing the bill to
amendments, waiving all points of order against the bill and its
consideration, deeming the previous question as ordered, providing for
three total hours of debate, and [providing for one motion to recommit
with instructions]{.underline}. (Note: H.Res. 6 was the resolution
changing House Rules for the 110^th^ Congress. It also provided for the
consideration of several portions of the Democrats' 100-Hour Agenda.)
**In other words, this bill will come to the floor under a closed rule
and without the applicability of any of the new House rules that the
Democrats have implemented.**

[Note]{.underline}: It is unclear what the motion to recommit will
entail. More information will be forthcoming as it becomes available.

**[Background]{.underline}:** In the 109^th^ Congress, a bill identical
to H.R. 3 (H.R. 810, the Stem Cell Research and Enhancement Act), passed
in the House by a vote of 238-194 ([Roll Call
204](http://clerk.house.gov/evs/2005/roll204.xml)) on May 24, 2005, and
passed the Senate by a vote of 63-37 ([Roll Call
206](http://www.senate.gov/legislative/LIS/roll_call_lists/roll_call_vote_cfm.cfm?congress=109&session=2&vote=00206))
on July 18, 2006. H.R. 810 was vetoed by President Bush on July 19, 2006
(his first and only presidential veto to-date). The same day, the House
failed to override the President's veto by a vote of 235-193 ([Roll Call
388](http://clerk.house.gov/evs/2006/roll388.xml)). A two-thirds vote is
required to override a presidential veto, thus the bill failed to
receive the required 286 votes and was defeated with a 51-vote margin.

**[Summary]{.underline}:** H.R. 3 creates a new provision in the Public
Health Service Act (42 U.S.C. 289 et seq.) requiring the Secretary of
HHS to "conduct and support research that utilizes human embryonic stem
cells \..." The bill defines as eligible for federal funding human
embryonic stem cells that:

-   were derived from human embryos that have been donated from in vitro
    fertilization clinics, were created for the purposes of fertility
    treatment, and were in excess of the clinical need of the
    individuals seeking such treatment;

-   it was determined would never be implanted in a woman and would
    otherwise be discarded; and

-   were donated with written informed consent and without receiving any
    financial or other inducements to make the donation.

The bill requires final guidelines from NIH within 60 days of enactment
and an annual report from the HHS Secretary describing the research
conducted.

**[Additional Information]{.underline}: It is legal in the United States
to destroy and conduct research on living and dead human embryos *with
non-federal funds*. It is also legal in the U.S. to conduct research
with federal funds on stem cell lines from embryos destroyed prior to
September 9, 2001.** This bill would require the federal funding of
research using [viable human embryos]{.underline}, which is currently
prohibited under federal law and the President's stem cell policy.

**REVERSAL OF CONGRESSIONAL FUNDING BAN AND PRESIDENT BUSH'S POLICY**

**President's Policy:**

> H.R. 3 will reverse President George W. Bush's federal stem cell
> policy announced in an address to the nation on August 9, 2001. In
> that address, the President stated that **no federal funds** will be
> used for:
>
> "the derivation or use of stem cell lines derived from newly destroyed
> embryos;
>
> "the creation of any human embryos for research purposes; or
>
> "the cloning of human embryos for any purpose."
>
> The President's policy did allow federal funds to be used for stem
> cell lines that had come from embryos already destroyed prior to
> August 9, 2001. At the time, the President stated, "The embryos from
> which the existing stem cell lines were created have already been
> destroyed and no longer have the possibility of further development as
> human beings." The President stated his policy permits federal funding
> of research using the more than 60 existing stem cell lines that have
> already been derived, but will not sanction or encourage the
> destruction of additional human embryos. He said in his address, "This
> allows us to explore the promise and potential of stem cell research
> without crossing a fundamental moral line by providing taxpayer
> funding that would sanction or encourage further destruction of human
> embryos that have at least the potential for life."

*Source:
<http://www.whitehouse.gov/news/releases/2001/08/20010809-1.html>.*

> To see a list of those stem cell lines that are *currently* eligible
> for federal funding, please visit:
> <http://stemcells.nih.gov/research/registry/eligibilityCriteria.asp>.

**Congressional Funding Ban:**

Since fiscal year 1996, Congress has included in the Labor, HHS and
Education Appropriations bill a rider that has been signed into law,
which states the following:

SEC. 509.

\(a\) **None of the funds made available in this Act may be used for
--**

> \(1\) the creation of a human embryo or embryos for research purposes;
> or
>
> \(2\) **research in which a human embryo or embryos are destroyed**,
> discarded, or **knowingly subjected to risk of injury or death**
> greater than that allowed for research on fetuses in utero under 45
> CFR 46.208(a)(2) and section 498(b) of the Public Health Service Act
> (42 U.S.C. 289g(b)).
>
> \(b\) For purposes of this section, the term human embryo or embryos
> includes any organism, not protected as a human subject under 45 CFR
> 46 as of the date of the enactment of this Act, that is derived by
> fertilization, parthenogenesis, cloning, or any other means from one
> or more human gametes or human diploid cells. (emphasis added)

*Source: Section 509 of the FY05 Omnibus Appropriations Act (H.R. 4818)*

> **\[Explanation of cross-references**: 45 CFR 46 is the part of the
> Code of Federal Regulations that contains protections for human
> subjects in federally funded research. 45 CFR 46.208(a)(2) requires
> that unless an experiment involving a human fetus is designed to
> benefit that particular child, **it cannot involve anything greater
> than a minimal risk of harm** (defined as a risk comparable to that
> involved in routine examinations or the activities of everyday life).
> These federal regulation protections cover all human embryos from
> implantation in the womb until birth; the appropriations rider on
> human embryo research (Sec. 510 above) covers all other human embryos
> (those not implanted in the womb).
>
> The Public Health Service Act (42 USC 289g (b)) requires that in
> assessing allowable risk, a child intended for abortion must be
> protected as fully from harmful research as the child intended for
> live birth. The argument that an embryo or fetus is unwanted or would
> be destroyed anyway cannot be used to justify harmful experimentation
> at taxpayers expense.\]

**THE HUMAN EMBRYOS AVAILABLE FOR RESEARCH UNDER H.R. 3:**

H.R. 3 will allow federal funds for the destruction of and research on
human embryos from in vitro fertilization (IVF) clinics.

The in vitro fertilization process involves combining an egg with sperm
to create a human embryo. At this stage, clinics are able to determine
whether or not the human embryos have the genetic makeup of a male or of
a female. According to IVF clinics, a human embryo that is "graded" as a
"quality" embryo is then implanted into a woman's womb (often more than
one at a time) to try and achieve implantation and a full-term
pregnancy. Those human embryos graded as "abnormal" are "discarded,"
according to various clinics.

(See: <http://www.advancedfertility.com/embryoquality.htm>).

Those human embryos deemed "quality" human embryos that are not
implanted into the womb are then usually frozen in a controlled-rate
freezer and immersed and stored in liquid nitrogen in a tank (at -196
degrees Centigrade), in a process called Cyroproservation (to see a
photo of a human embryo storage freezer, please visit:
<http://www.advancedfertility.com/cryotank.htm>).

The frozen human embryos can be stored for many years and can be
defrosted to be implanted into a woman's womb. Some parents place their
unused frozen human embryos through an official adoption process with
other couples (see:
<http://www.nightlight.org/snowflakes_description.asp> and Congressional
testimony: <http://www.stemcellresearch.org/testimony/strege.htm>). More
commonly, parents allow the IVF clinic to offer their unused frozen
human embryos to other infertile female patients through the clinic
(see:
<http://embryodonation.org/downloads/pdf/DonationConsentGeneric.pdf>).

**The Number of Human Embryos Eligible for Destruction and Research
Under H.R. 3:**

Many of the human embryos do not survive the freezing and defrosting
process. A group of RAND researchers estimated that only 65% of the
human embryos survive the freeze-and-thaw process.

The most comprehensive study of the number of human embryos currently in
existence at IVF clinics was done by the non-profit research
organization RAND. In 2003, RAND released a study that found that as of
April 11, 2002, nearly 400,000 human embryos have been "frozen and
stored since the late 1970s."

Of the 400,000, 2.8% (11,000 total) have been made available by their
parents for research, while the "vast majority of frozen \[human\]
embryos are designated for future attempts at pregnancy."

The vast majority of stored human embryos, 88.2%, are being held for
"family building;" 2.3% are awaiting donation to another patient (for
implantation in her womb); and 4.5% are held in storage for other
reasons, including lost contact with a patient, patient death,
abandonment, and divorce.

The RAND researchers noted that based on current, non-federally funded
research results, if all 11,000 embryos were used to create embryonic
stem cell lines (the cell culture lines federal funds would be used for
under H.R. 3), "about 275 embryonic stem cell lines could be created"
and that "the actual number is likely to be much lower." The University
of Wisconsin used 18 human embryos (that were grown for five days from
the date of their conception before being destroyed) to create five
embryonic stem cell *lines*. The Jones Institute used 40 embryos of the
same age, to create only three stem cell *lines*.

*Source: How Many Frozen Human Embryos Are Available for Research? RAND
Law &*

*Health Research Brief, May 2003,
<http://www.rand.org/publications/RB/RB9038/>*

**NO TREATMENTS TO DATE FOR HUMANS OR ANIMALS FROM EMBRYO STEM CELL**

**RESEARCH:**

As of January 2007, [no animals or human patients have been successfully
treated]{.underline} with human embryonic stem cells (see:
<http://www.stemcellresearch.org/facts/treatments.htm>).

**H.R. 3 AND HUMAN CLONING:**

Because the bill overrides current law, if a human embryo clone was
created by an in vitro fertilization clinic for fertility purposes, H.R.
3 would allow federal funds for research on the human clone embryo.
Opponents of H.R. 3 have noted that most of the organizations most
actively promoting H.R. 3, such as the Biotechnology Industry
Organization and the Coalition for the Advancement of Medical Research,
are also strong supporters of a certain type of cloning they call
therapeutic cloning. Senator Orrin Hatch, the sponsor of a pro-human
cloning bill, referred to H.R. 3 as a critical first step, an apparent
reference to a pro-cloning bill being the next step.

**For several other resources on embryonic stem cell research, and
recent breakthroughs on non-embryonic stem cell research, please visit
the RSC Website at:
<http://www.house.gov/pence/rsc/lifeissues_abortion.shtml>.**

**[Committee Action]{.underline}**: The bill was introduced on January
5, 2007, and referred to the House Committee on Energy and Commerce,
which took no official action.

**[Cost to Taxpayers]{.underline}**: A CBO cost estimate is unavailable.
According to news reports, in FY04 NIH spent \$24.6 million funding the
research allowed on cell lines created from cells removed from human
embryos prior to August 2001. **H.R. 3 requires federal funding of human
embryo research regardless of the date on which the stem cells were
derived from a human embryo, which would likely lead to millions of
dollars in additional federal spending.**

**[Constitutional Authority]{.underline}**: An Energy and Commerce
Committee report citing constitutional authority is unavailable.

**[Administration Position]{.underline}:** The Administration is opposed
to passage of H.R. 3 but has not released an updated Statement of
Administration Policy (SAP) as of press time. However, the
Administration released a SAP on H.R. 810 on May 24, 2005, which stated:

> "The Administration strongly opposes House passage of H.R. 810, which
> would require Federal taxpayer dollars to be used to encourage the
> ongoing destruction of nascent human life. The bill would compel all
> American taxpayers to pay for research that relies on the intentional
> destruction of human embryos for the derivation of stem cells,
> overturning the President's policy that supports research without
> promoting such ongoing destruction. If H.R. 810 were presented to the
> President, he would veto the bill."

To read the full SAP, please visit:

<http://www.whitehouse.gov/omb/legislative/sap/109-1/hr810sap-h.pdf>.

**[Outside Organizations]{.underline}:** The following is a partial list
of outside organizations opposing H.R. 3 (note: groups that scored the
original House vote last year and are likely to score it again are noted
with an asterisk):

> National Right to Life Committee\*
>
> US Conference of Catholic Bishops
>
> Family Research Council\*
>
> Christian Coalition\*
>
> Concerned Women for America\*
>
> Focus on the Family
>
> Christian Medical Association
>
> Eagle Forum\*
>
> Traditional Values Coalition
>
> Southern Baptist Convention
>
> Susan B. Anthony List
>
> Republican National Committee for Life
>
> Cornerstone Policy Research
>
> Culture of Life Foundation
>
> Religious Freedom Coalition
>
> Coral Ridge Ministries
>
> Center For Reclaiming America

**[Does the Bill Create New Federal Programs or Rules?]{.underline}**:
Yes. The bill would override current federal funding bans and the
President's current administrative policy to require the HHS Secretary
to fund human embryonic research, including research on currently living
human embryos stored in freezers at IVF clinics.

**[Does the Bill Contain Any New State-Government, Local-Government, or
Private-Sector Mandates?]{.underline}**: No.

**[RSC Staff Contact]{.underline}:** Derek V. Baker;
[derek.baker@mail.house.gov](mailto:Derek.baker@mail.house.gov);
202-226-8585

\###