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Monitoring Stem Cell Research


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The President's Council on Bioethics
Washington, D.C.
January 2004
www.bioethics.gov


(The following commissioned paper was prepared at the request of the President’s Council on Bioethics; the Council has not itself verified the accuracy of the information contained therein, nor does it necessarily endorse any of the author's conclusions or opinions. Additionally, the Council has not edited this paper either for style or content.)

Appendix E

LEGISLATORS AS LOBBYISTS: PROPOSED STATE REGULATION OF EMBRYONIC STEM CELL RESEARCH, THERAPEUTIC CLONING AND REPRODUCTIVE CLONING

 

Lori B. Andrews, J.D.
Distinguished Professor of Law,
Chicago Kent College of Law, Illinois Institute of Technology

The issue of research involving embryos and fetuses has been a matter of serious social concern for the past three decades.  As each new scientific and medical development is introduced that affects embryos and fetuses, new state laws are proposed to deal with them.  In the wake of the 1973 U.S. Supreme Court abortion decision in Roe v. Wade,1 for example, 24 states passed laws prohibiting research on human conceptuses.2 When in vitro fertilization (IVF) was accomplished, at least one state passed a law attempting to discourage the procedure.3  After Dolly the cloned sheep was born, nine states adopted laws restricting human reproductive cloning.4  When researchers began creating and using human embryos for stem cell research, states began introducing laws to deal with that technology as well.  In 2002 and 2003, dozens of bills were introduced in state legislatures on cloning and stem cell research.  In total, 38 states considered such bills;5 some states considered multiple and conflicting bills.  In all, 133 separate bills were introduced on these subjects.  (See overview in Chart II and specific provisions in Chart III).

Although state legislatures have addressed regulation of research on the unborn for 30 years, the more recent technologies are being debated within a new context.  Pro-life and pro-choice advocates are aligning in unusual ways.  Unlike the clear line of demarcation between the groups on the issue of abortion, some pro-choice advocates oppose all forms of human cloning6 and some pro-life advocates support so-called "therapeutic" cloning.7  It would seem that these unique alliances might allow more fruitful policy discussions.  However, despite agreement across traditional boundaries on the substance of particular bills, some of the new alliances break down because the sponsors of the bills include preambles that evince either pro-life or pro-biotechnology sentiments that go far beyond the substance of the bills themselves.  This is a new development in the policy considerations related to human conceptuses.  The legislators themselves are acting like lobbyists by including within their bills language espousing a particular position that goes far beyond the bills' actual legal substance.8 Some bills seem to be driven more by political posturing than by an attempt to actually get legislation enacted to deal with the issue at hand.

This paper surveys the state law landscape by analyzing 1) existing laws with implications for reproductive cloning, therapeutic cloning and embryo stem cell research, 2) proposed bills addressing those technologies, and 3) potential constitutional challenges to the laws.

I. The Existing Legal Framework

A.  Existing Bans on Cloning

1. The Restrictions

There are eight states that have enacted explicit laws to ban reproductive cloning,9 and one state that prohibits only the use of state funds for reproductive cloning.10  (See Chart I).  Of these eight states, four also ban "therapeutic" cloning.11 Some states also ban shipping, transferring, or receiving for any purpose an embryo produced by human cloning.12

Under the existing reproductive cloning bans, some states ban the purchase or sale of an ovum, zygote, embryo, or fetus for the purpose of cloning a human being.13 Other states, however, have bans on payment for eggs, embryos, or human tissue that could also cover some of the transactions involved in reproductive or "therapeutic" cloning.14

California's initial anti-cloning bill, adopted in 1998, created an advisory committee that met frequently over a five year period, heard extensive testimony from scientists and members of the public, and issued a report.15

2. Exceptions for Certain Research

In some states, the ban on reproductive cloning is accompanied by language supporting other types of research or medical practices.  In Louisiana and Michigan, for example, the cloning bans say that they do not prohibit scientific research on a cell-based therapy.16  Similarly, some states allow the use of nuclear transfer or other cloning techniques to produce molecules, DNA, cells other than human embryos, tissues, organs, plants, or animals other than humans.17 The Arkansas and Rhode Island laws also specifically allow in vitro fertilization and fertility enhancing drugs, so long as they are not used in the context of human cloning.18  The Iowa law more broadly allows in vitro fertilization and the use of fertility drugs.19

3. Penalties

The penalties for violation of existing cloning bans range widely.  In Louisiana and Michigan, for example, penalties can be up to 10 years imprisonment and fines of $10 million for an entity such as a clinic or corporation and $5 million for an individual.20  In contrast, in Arkansas the penalty is a mere $250,000, but there are also felony criminal penalties.21 Moreover, in some states, cloning can result in the permanent revocation of a doctor's license22 and the denial of any other type of license or permit from the state regarding any trade, occupation or profession.23

B. Existing Bans on Embryo Research

Twelve states' laws apply to in vitro embryos.  In New Hampshire, the regulation of research on embryos prior to implantation is minimal.24  The research must take place before day 14 post-conception,25 and the subject embryo must not be implanted in a woman.26 These stipulations could readily be met by researchers wanting to use IVF embryos as a source of stem cells. 

Nine states ban research on in vitro embryos altogether,27 and two states ban destructive embryo research.28 In Louisiana, an in vitro fertilized ovum may not be farmed or cultured for research purposes;29 the sole purpose for which an IVF embryo may be used is for human in utero implantations.30

In the other states, embryo research is banned as part of the broader ban on all research involving live conceptuses.  These laws ban embryo stem cell research.  The penalties are high -- in some states, the punishment includes imprisonment.31

In some instances, the woman or couple who donate an embryo or fetus for research purposes also face liability.  Laws in Maine, Michigan, North Dakota, and Rhode Island prohibit the transfer, distribution, or giving away of any live embryo for research purposes.32  In Maine, a person who does so is subject to a fine of up to $5,000 and up to five years' imprisonment.33

C. Existing Laws Specifically Addressing Embryo Stem Cell Research

A California law declares that research shall be permitted on human embryonic or adult stem cells from any source, including somatic cell nuclear transfer.34  Such research must be reviewed by an approved institutional review board and such research may not be undertaken without written informed consent of the embryo donor.  Interestingly, the law does not say consent of the "donors," plural.  So it would appear that the female patient of infertility services (and not the woman and her husband) is the sole source of consent.  California also enacted a law urging Congress to ban reproductive cloning, while permitting therapeutic cloning and embryo stem cell research.35

II. Proposed Bills36

A. Preambles to the Bills - Hype versus Doom  

Legislators are currently considering bills that govern the technologies of cloning or embryo stem cell research. But even when the provisions of those bills are narrowly tailored to deal with those specific technologies, lawmakers include extensive preambles that include sweeping pro-life or pro-biotechnology language.  None of the bills include a pro-choice preamble. 

A Kentucky bill attempts to fuel a biotechnology sector in the state.  Its preamble mentions the "great potential" of nuclear transplantation to treat "diseases and disorders, including but not limited to Lou Gehrig's disease, Parkinson's disease, Alzheimer's disease, spinal-cord injury, cancer cardiovascular diseases, diabetes, rheumatoid arthritis, and many others."37  Its provisions would require anyone engaging in therapeutic cloning to register with the health department and pay a $50 fee.  The bill also implores public colleges in Kentucky to protect "the interest of the Commonwealth or the institution relating to all intellectual property and other rights to any research, experiments, or other activity related to human nuclear transplantation. . . ."38

On the other hand, some bills' preambles are designed to cast aspersions on the technologies.  The preamble of a Virginia Senate resolution contains a hodge-podge of historical facts (from slavery in Virginia 1619 to 1865 to Advanced Cell Technologies cloning of an embryo), Presidential statements (from President Reagan through President George W. Bush), and concerns about eugenics and commodification of humans.39  The resolution would establish a legislative task force, but its agenda is directed in a one-sided way.  It is supposed to "examine the medical, ethical and scientific policy implications of prohibiting the creation of embryos in vitro for any purpose other than bringing them to birth, and the criminalizing of the transfer of compensation, in cash or in-kind, to induce any person to donate sperm or eggs for any purpose other than procreation. The joint subcommittee shall also examine the efficacy of research using adult stem cells rather than embryonic stem cells."40

Some bills assert scientific or medical facts that are not necessarily accurate.  For example, Louisiana's resolution says, "stem cells derived from adult or placental tissues may hold greater promise than embryonic stem cells for human medicine, due to a lesser danger of immune reactivity against a recipient."41

B. Proposed Bills on Reproductive Cloning

1. The Restrictions

In 2002 and 2003, 27 states introduced bills that would ban reproductive cloning.42 One bill details a specific enforcement mechanism for the human cloning ban.  A New Jersey bill provides that the Commissioner of Health and Senior Services may issue a cease and desist order, with a subsequent administrative hearing within 20 days, with judicial review available.43 

Many of these proposed laws suffer from drafting infirmities.  For example, some of the states' proposals create a loophole by only prohibiting the reproduction of a "genetically identical" individual through cloning.44  Since the current cloning technique uses a donated egg to create a clone, the resulting individual will have some additional mitochondrial DNA from the enucleated egg, so he or she will not be genetically identical to the original individual.45  In contrast, other states' bills prohibit the reproduction of a "virtually genetically identical" individual through human cloning using a human or non-human egg,46 which would apply even if a donated egg, containing additional mitochondria were used.

Certain states' bills would prohibit the transferring of a human cell into a human egg cell.47  But, in January 1998, scientists at the University of Wisconsin revealed that cow eggs could serve as incubators for nucleic DNA of other mammalian species.48  Thus, the proposed laws could be evaded by making a human clone via somatic cell DNA transfer into an enucleated cow egg.  Other states' bills prohibit human reproductive cloning using a human or non-human egg.49 

A New Jersey bill has the opposite problem.  Rather than being too narrow, it is too broad, using vague language in places and even potentially banning the creation of children through sexual intercourse.50 The focus of the bill is to ban human cloning and germline genetic engineering.  But it defines human cloning as the replication of one or more human beings, through "sexual or asexual reproduction."  When two people create a child sexually are they replicating themselves?  The key word, "replication," is not defined. 

The bill prohibits the destruction of human or non-human embryos "for the purpose of human cloning."51  There is a certain vagueness to that provision.  If a researcher working on primate cloning generates data that might be useful to cloning human beings could he or she be prosecuted?

2.  Public funds

Six states' bills would prohibit the use of public funds and facilities to participate in cloning or attempted cloning.52

3.  Other Means to Discourage Cloning

Some states' bills attempt to discourage reproductive cloning by prohibiting either the sale or purchase53 or the shipment or receival of an ovum, zygote, embryo, or fetus to clone a human.54  Some states' laws attempt to discourage cloning through liability provisions.  A Florida bill would create vast liabilities as another means to discourage cloning.55 Participants in human reproductive cloning would be liable to "the individual, the individual's spouse, dependents, and blood relatives, and to any woman impregnated with the individual, her spouse, and dependents, for damages for all physical, emotional, economic, or other injuries suffered by such persons at any time as a result of the use of human cloning to produce the individual."  Even more dramatically, participants in human reproductive cloning would be liable to the cloned individual and his or her legal guardian for support until the age of majority (or longer, if the clone has "any congenital defects or other disability" related to the cloning).

4. Exceptions

Eighteen states' bills have an exception allowing cloning to create DNA, tissues, and organs.56 Eleven states' bills would not restrict the use of in vitro fertilization or fertility enhancing drugs.57

C.  Proposed Bills on Therapeutic Cloning

There are 26 states that have bills about therapeutic cloning.58  Two states have at least one bill that would ban therapeutic cloning and at least one that would allow therapeutic cloning.59

1.  Ban Therapeutic Cloning

Twenty-six states have bills that would prohibit all human cloning including therapeutic cloning.60 Some states prohibit therapeutic cloning through a general cloning ban that defines human cloning as the creation of any human organism through somatic cell nuclear transfer.61 Others prohibit therapeutic cloning by banning not only the creation of the cloned embryo, but also the "derivation of any product from human cloning."62

2.  Allow Therapeutic Cloning

Two states have bills that specifically allow therapeutic cloning.63  In addition, twelve other states allow for the use of stem cells from any source, including those derived from somatic cell nuclear transplantation.64

One state bill would encourage researchers to do stem cell research using only human adult or placental tissues obtained with informed consent, and would discourage research involving human embryonic or fetal tissue.65  One state's bill urges state universities to refrain from embryonic stem cell research.66

D.  Proposed Bans on Embryo Stem Cell Research 1.  Ban Embryo Stem Cell Research

Five states have bills that would prohibit acts where a human fetus or embryo is destroyed or subject to injury.67  New Jersey has these provisions in a cloning bill, while Wisconsin has them in an artificial insemination/in vitro fertilization bill.68 The others (Kansas, Michigan, and Virginia) have these provisions in stem cell research bills.69 One state's bill would make all contracts for payment for the extraction or use of embryonic stem cells against public policy, void, and unenforceable.70  In addition, a Michigan bill, in its preamble, opposes the White House decision to allow certain embryonic stem cell research.71 The substance of the bill is a provision urging the state's public universities to refrain from embryonic stem cell research.72

2.  Allow Embryo Stem Cell Research, Including Therapeutic Cloning

Twelve states have bills that would allow embryo stem cell research from any source.73  While the bills literally say "from any source," some also have a list saying this includes human embryonic stem cells, human embryonic germ cells, and human adult stem cells, from any source, including somatic cell nuclear transplantation.74 In the states where proposed bills would permit embryonic stem cell research, there are often provisions regarding how the research should be conducted.  In eleven states, for example, physicians undertaking in vitro fertilization on patients must discuss options for the disposition of frozen embryos, including donation to research, and written informed consent for such donation would have to be obtained.75  In at least one state, the proposed research must be assessed by a state department,76 and in eleven states the research must be assessed by an institutional review board.77  A Kentucky bill requires that individuals engaged in therapeutic cloning must register their name, address, and phone number, which information shall be public record.78  Under one proposed California bill, the State Department of Health Services would have the responsibility to develop guidelines regarding the derivation or use of human embryonic stem cells.79

In Illinois, care was taken in the proposed bill favoring embryonic stem cell research not to create barriers for the research due to contract or tort liability.  Consequently, the proposed Illinois bill states that "procuring, furnishing, donating, processing, distributing, or using embryonic or cadaveric fetal tissue for research purposes pursuant to this Act is declared for the purposes of liability in tort or contract to be the rendition of a service by every person, firm, or corporation participating therein, whether or not remuneration is paid, and is declared not to be a sale of any such items and no warranties of any kind or description nor strict tort liability shall be applicable thereto."80

3.  Address Embryo Donation

Twelve states' bills would expressly allow a person to donate human embryos for research.81 Twelve states' bills would also prohibit the sale of embryonic or cadaveric fetal tissue for research purposes.82

4. Review Committees

Six states' bills would establish a subcommittee or task force to review and/or study issues related to stem cell research.83 Some of these states have a bill that only establishes a task force.84 Some states establish this task force, subcommittee, or review board within a bill relating to stem cell research.85  Maryland has one of each.86

It has often been true in the bioethical area that when controversial new technologies are introduced, states propose commissions to address the issue.87 Often, the creation of the commission is a stalling tactic to avoid having to confront the issue head on or to postpone having to limit a technology, or to facilitate a moratorium on the technology (while the Commission evaluates the technology).  Sometimes, though, state commissions have admirably overseen a technology's development, application and evaluation.  Such was the case in the 1970's and 1980's with Maryland's newborn screening commission.  So it is no surprise that of the bills proposing a state task force or commission, the Maryland bill provides the best guidance about what the commission would do.  The Maryland task force would:

"(1) Make recommendations for state policy regarding stem cells derived from embryos created solely for research purposes;

(2) evaluate whether there should be written informed consent requirements for prospective donors of embryonic stem cells derived from embryos created during infertility treatment;

(3) study constitutional, ethical, and policy issues with respect to whether the state should regulate or prohibit commerce in embryos or stem cells;
(4) (i) determine what stem cell research is already being done in the state by private companies and academic institutions; and
(ii) evaluate how these companies and institutions are regulating themselves when doing stem cell research;
(5) determine the effect on Maryland businesses and institutions of Federal restrictions that limit federally funded research and development to existing cell lines on stem cell research;
(6) analyze the roles of, and interrelationship between, federal and state oversight of stem cell research; and

(7) review any other matter relating to stem cell research that the task force considers necessary and proper."88

5. Public Funding or Tax Credits for Stem Cell Research

States have also proposed bills allowing for or prohibiting the granting of state funds for stem cell research.  California's proposed "Biomedical Research and Development Act of 2004" would award grants or loans to public or private institutions conducting research in stem cell biology.89 To be eligible for funding, all research projects must be reviewed and approved by an institutional review board.

The states of Indiana, Michigan, Mississippi, and Nebraska have gone the opposite direction and introduced bills specifically prohibiting the use of state money or tax credits for stem cell research.90 The Indiana bill proposes an amendment to the state tax code denying tax exemptions and credits for research involving human cloning or stem cell research with embryonic tissue.

A Mississippi House Bill and a Mississippi Senate Bill provide that no public funds shall be used to assist in or to provide facilities for stem cell research that uses cells from human embryos and human cloning. 

Finally, although not establishing public funds for embryonic stem cell research, six Florida bills seek to establish a center for "Universal Research to Eradicate Disease" which will facilitate funding opportunities for stem cell research.91

E.  Proposed Bills on Health Care Providers' Right of Conscience

In addition to proposing bills on the prohibition of or allowance of embryonic stem cell research and cloning, a number of states have proposed bills protecting a health care provider, payer, or institution's right to refuse certain services based on moral or ethical convictions.  Kansas, Louisiana, and Rhode Island have all introduced bills entitled "Health Care Providers Rights of Conscience." 92

The Kansas bill introduced on January 28, 2002, specifically allows all persons to refuse to participate in the provision of, or pay for, a health care service related to human cloning and embryonic stem cell and fetal experimentation.  The Louisiana bill and the identical Rhode Island House and Senate bills allow all health care providers, institutions and payers to decline to counsel, advise, pay for, provide, perform, assist, or participate in providing or performing health care services that violate their consciences, including, human cloning and embryonic stem cell research. 

F.  Constitutionality of State Law

Not all regulations affecting research are constitutional.  Laws restricting research on conceptuses may be struck down as too vague or as violating the right to privacy to make reproductive decisions.  Such a challenge was successful in a federal district court case, Lifchez v. Hartigan,93 which held that a ban on research on conceptuses was unconstitutional because it was too vague in that it failed to define the terms "experimentation" and "therapeutic."94  The court pointed out that there are multiple meanings of the term "experimentation."95 It could mean pure research, with no direct benefit to the subject.  It could mean a procedure that is not sufficiently tested so that the outcome is predictable, or a procedure that departs from present-day practice.  It could mean a procedure performed by a practitioner or clinic for the first time.  Or it could mean routine treatment on a new patient.  Since the statute did not define the term, it was unconstitutionally vague.  It violated researchers' and clinicians' due process rights under the fifth amendment since it forced them to guess whether their conduct was unlawful.96

A similar result was reached by a federal appellate court assessing the constitutionality of a Louisiana law prohibiting nontherapeutic experimentation on fetuses in Margaret S. v. Edwards.97 The appeals court declared the law unconstitutional because the term "experimentation" was so vague it did not give researchers adequate notice about what type of conduct was banned.98The court said that the term "experimentation" was impermissibly vague99 since physicians do not and cannot distinguish clearly between medical experimentation and medical tests.100 The court noted that "even medical treatment can be reasonably described as both a test and an experiment."101 This is the case, for example, "whenever the results of the treatment are observed, recorded, and introduced into the data base that one or more physicians use in seeking better therapeutic methods."102

A third case struck down as vague the Utah statute that provided that "live unborn children may not be used for experimentation, but when advisable, in the best medical judgment of the physician, may be tested for genetic defects."103 The Tenth Circuit held "[b]ecause there are several competing and equally viable definitions, the term 'experimentation' does not place health care providers on adequate notice of the legality of their conduct."104

In a fourth case, Forbes v. Napolitano,105 a number of plaintiffs106 challenged the constitutionality of an Arizona statute that criminalized medical experimentation or investigation involving fetal tissue from induced abortions.107  The statute at issue in that litigation, A.R.S. § 36-2302(A), provides: A person shall not knowingly use any human fetus or embryo, living or dead, or any parts, organs, or fluids of any such fetus or embryo resulting from an induced abortion in any manner for any medical experimentation or scientific or medical investigation purposes except as is strictly necessary to diagnose a disease or condition in the mother of the fetus or embryo and only if the abortion was performed because of such disease or condition.108

An exception to this is found in A.R.S. § 36-2302(C), which reads:

This section shall not prohibit any routine pathological examinations conducted by a medical examiner or hospital laboratory provided such pathological examination is not part of or in any way related to any medical or scientific experimentation.109

The penalty for violation of A.R.S. § 36-2302, a class 5 felony, is one and a half years in prison and fines up to $150,000.110

Plaintiffs argued that the statute prevented fetal tissue transplantation treatment of Parkinson's disease, certain fertility treatments, and development of treatments for illness.111  The court ultimately affirmed the decision of the lower court112 in holding that the statute was unconstitutionally vague.113  Specifically, the "distinction between experiment and treatment in the use of fetal tissue is indeterminate, regardless of whether the tissue is obtained after an induced abortion."114  Furthermore, the court determined that a criminal statute that serves to prohibit medical experimentation but provides no guidance as to where to draw the line between experiment and treatment does not provide doctors with constructive notice, nor does it provide police, prosecutors, juries, and judges with standards for application.115

Specific bans on embryo stem cell research are unlikely to raise the same constitutional concerns.  Part of the constitutional deficiency in the Arizona, Illinois, Louisiana, and Utah cases was that physicians offering health care services for their patients (such as embryo donation from an infertile woman, preimplantation genetic screening on an embryo, or treatment of a pregnant woman for diabetes) would not know if the activity would be considered by prosecutors to be experimental with respect to the embryo or fetus.  Moreover, the female patient's reproductive freedom was implicated in the previous cases, providing another reason for overturning the statute.  Stem cell researchers do not have those potential legal arguments.  There is a slight possibility, however, a reproductive liberty challenge could be raised against a law banning reproductive cloning.116

Conclusion

Bills on cloning and stem cell research are the subjects of vast media attention and public debate.  As technologies develop that focus increasingly on the human embryo, lawmakers are having difficulty coming to agreement on legislative policy in the absence of societal accord about the moral and legal status of the embryo.

[PLEASE SEE THE ACCOMPANYING CHARTS DETAILING STATE LAWS AND BILLS RELEVANT TO THIS AREA.  ADDITIONAL INFORMATION IS AVAILABLE ON THE COUNCIL'S WEBSITE AT WWW.BIOETHICS.GOV IN THE ELECTRONIC VERSION OF THIS REPORT AS WELL AS IN THE TRANSCRIPTS OF THE AUTHOR'S PRESENTATION TO THE COUNCIL AT ITS JULY 24, 2003, MEETING.]

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ENDNOTES

1.  Roe v. Wade, 410 U.S. 113 (1973).

2. See Lori B. Andrews, Medical Genetics:  A Legal Frontier 70 (Chicago:  American Bar Foundation, 1987).

3. See description of the Illinois law in Lori B. Andrews, The Clone Age:  Adventures in the New World of Reproductive Technology 24-28 (New York: Henry Holt, 1999).

4. See Section IA, infra.

5. Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New York, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia, Wisconsin.

6. See, for example, Nigel Cameron and Lori Andrews, "Cloning and the Debate on Abortion," Chicago Tribune, August 8, 2001, at 17.

7. Orin Hatch, for example.

8. See Section II, infra.

9.  Ark. Code § 20-16-1001 et seq. (2003) (formerly AR SB 185); Cal. Bus. & Prof. §§16004, 16105 (2003) and  Calif. Health & Safety §§ 24185-24187 (2003) (formerly CA SB 1230); Iowa Code § 707B.1-.4 (2003) (formerly IA SB 2046, became IA SB 2118); La. Rev. Stat. Ann. § 1299.36.1-.6 (2003); Mich. Comp. Laws §§ 333.26401-06, 333.16274, 16275, 20197, 750.430a (2003); ND  Cent. Code §§ 12.1-39-01 to 02 (2003) (formerly ND HB 1424); RI Gen. Laws § 23-16.4-1 to .4-4 (2003); Va. Code Ann. § 32.1-162.21 to .22 (2003).  Two of these state laws could be evaded if a non-human egg was used instead of a human egg as the incubation for the somatic cell DNA.  Ark. Code § 20-16-1001(5) (2003); La. Rev. Stat. § 1299.36.1 (2003).

10. Mo. Rev. Stat. § 1.217 (2003).

11. Arkansas, Iowa, Michigan, and North Dakota.

12. Ark. Code § 20-16-1002 (A)(3); Iowa Code § 707B.4(1)(c); ND  Cent. Code §§ 12.1-39-01 to 02; Va. Code Ann. § 32.1-162.22(A) (for purposes of implantation).

13. See, for example, Cal. Health & Safety Code §§ 24185(b); La. Rev. Stat. § 1299.36.2(B).

14. Lori B. Andrews, "State Regulation of Embryo Stem Cell Research," in National Bioethics Advisory Commission, Appendix II at pages A1 - A13.

15. "Cloning Californians?" Report of the California Advisory Committee on Human Cloning, January 11, 2002, Sacramento, California, available at http://www.sfgate.com/chronicle/cloningreport/.

16. La. Rev. Stat. Ann. § 1299.36.2(c); Mich. Comp. Laws § 750.430a(2).

17. See, for example, Ark. Code § 20-16-1003(A); Iowa 707B.4(2); R.I. Gen Laws § 23-16.4-1 (specifically allows animal cloning in another section, R.I. Gen Laws. § 23-16.4-2(c)(1)(iii)).  Virginia allows gene therapy, cloning of non-human animals, and cloning molecules, DNA, cells or tissue.  Va. Code Ann. § 32.1-162.22(B).

18. Ark. Code § 20-16.1003(B); R.I. § 23-16.4-2(c)(2)(i).  Rhode Island's bill goes overboard in its hype about scientific progress. Rhode Island's preamble to its reproductive cloning ban states, "recent medical and technological advances have had tremendous benefit to patients, and society as a whole, and biomedical research for the purpose of scientific investigation of disease or cure of a disease or illness should be preserved and protected and not be impeded by regulations involving the cloning of an entire human being; and . . . molecular biology, involving human cells, genes, tissues, and organs, has been used to meet medical needs globally for twenty (20) years, and has proved a powerful tool in the search for cures, leading to effective medicines to treat cystic fibrosis, diabetes, heart attack, stroke, hemophilia, and HIV/AIDS."  R.I. Gen. Laws. § 23-16.4-1.

19. Iowa Code § 707B.4(2). 

20. La. Rev. Stat. § 1299.36.3; Mich. Comp. Laws § 750.430(a)(3) (in Michigan even individuals too, can be fined up to $10 million.)  Rhode Island has a penalty of $250,000 for individuals and $1 million for entities.  R.I. Gen. Laws § 23-16.4-3. 

21. Ark. Code § 20-16-1002 (B ) to (D).

22. See, for example, La. Rev. Stat. § 1299.36.4; See also, Iowa § 707B.4(5).

23. La. Rev. Stat. § 1299.36.4; Iowa § 707B.4(6).

24. N.H. Rev. Stat. Ann. § 168-B:15.

25. N.H. Rev. Stat. Ann. § 168-B:15 at I.

26. N.H. Rev. Stat. Ann. § 168-B:15 at II.

27. Fla. Stat. Ann. § 390.0111(6); La. Rev. Stat. Ann. § 9:121 et. seq.; Me. Rev. Stat. Tit. 22 § 1593; Mass. Ann. Laws. Ch. 112 § 12J; Mich. Comp. Laws. §§ 333.2685 to 2692; Minn. Stat. Ann. § 145.421 (applies only until 265 days after fertilization); N.D. Cent. Code §§ 14-02.2-01 to -02; 18 Pa. Cons. Stat. Ann. § 3216; R.I. Gen. Laws. § 11-54-1.

28. S.D. Codified Laws § 34-14-16; Iowa Code § 707B.1-4.

29. La. Rev. Stat. Ann. § 9:122.

30. La. Rev. Stat. Ann. § 9:122.

31. The Maine law, which applies both to research on embryos and research on fetuses, carries a maximum five year prison term.  Me. Rev. Stat. tit. 22 § 1593.  The Massachusetts and Michigan laws also carry with them a potential prison sentence of up to five years.  Mass Ann. Laws 112 § 12J(a)(V); Mich. Comp. Laws § 333.2691.

32. Me. Rev. Stat. Ann. tit. 22 § 1593; Mich. Comp. Laws Ann. § 333.2690; N.D. Cent. Code § 14-02.2-2(4); R.I. Gen. Laws § 11-54-1(f).  In addition, S.D. Codified Law § 34-14-7 bans the sale or transfer of an embryo for nontherapeutic purposes.

33. Me. Rev. Stat. Ann. tit. 22 § 1593.

34. Cal. Health & Safety Code § 125115.

35. California Senate Joint Resolution 38.

36. This research was undertaken in Lexis current session bill text and bill text archive for 2002 and 2003, using the words "human cloning," "stem cell research," "embryo," "cloning," "twinning," "oocyte," and "somatic cell nuclear transfer" in order to locate bills.

37. KY HB 265.

38. KY HB 265.

39. "WHEREAS, although the "commodification" of human of human beings existed in this Commonwealth and the United States from 1619 to 1865, the concept of human beings as property has been rejected by Americans in their constitution and in their deeply held belief in the value of human life; and

WHEREAS, Ronald Reagan, the 40th President of the United States, stated this country understood that the personhood of every American should be protected "from the moment of conception until natural death"; and

WHEREAS, the United States Patent and Trade Office rejected human commercialization in a ruling on April 7, 1987, which stated "A claim directed to or including within its scope a human being will not be considered to be patentable subject matter" under the federal patent law; and

WHEREAS, on August 25, 2000, the National Institutes of Health published guidelines relating to stem cell research and the funding thereof that called for the denial of funding for research involving stem cells derived from embryonic human beings created for research purposes and noted that President Clinton, many members of Congress and the NIH Human Embryo Research Panel and the National Bioethics Advisory Committee had all endorsed the "distinction between embryos created for research purposes and those created for reproductive purposes"; and

WHEREAS, the NIH guidelines also called for assurances that "there can be no incentives for donation" of human embryos and "any inducement for the donation of human embryos for research purposes" would be prohibited; and

WHEREAS, George W. Bush, the 43rd President of the United States noted on August 9, 2001, that he is "deeply troubled" by the creation of "human embryos in test tubes solely to experiment on them," and described this act as a "warning sign" to "all of us" as Americans; and

WHEREAS, Senator William Frist, distinguished physician representing the State of Tennessee in the United States Senate, has proposed as a first principle of ethical research that "the creation of human embryos solely for research should be strictly prohibited"; and

WHEREAS, recently a Massachusetts research company claimed that it had cloned the first human embryo, that " [T]his work sets the stage for human therapeutic cloning as a potentially limitless source of immune-compatible cells," and that this work provides "hope for people with spinal injuries, heart disease and other ailments"; and

WHEREAS, the Jones Institute of Norfolk recently published research involving stem cell research conducted through the creation of approximately 110 embryos developed with the purchased sperm and eggs from men and women; and

WHEREAS, this conduct established a trade in new human life that treats such lives as merchandise for manipulation and destruction; and

WHEREAS, reportedly, the Jones Institute screened and evaluated the fitness of new human life according to the absence of "cosmetic handicaps, and other eugenic formulations"; and

WHEREAS, the General Assembly of Virginia has, by way of HJR 607 of 2001, condemned past practices within the Commonwealth involving institutional involvement in eugenics and eugenic ideology; now, therefore, be it

RESOLVED by the House of Delegates, the Senate concurring, That a joint subcommittee be established to study the medical, ethical, and scientific issues relating to stem cell research conducted within the Commonwealth." VA HJR 148.  See also VA HJR 573. 

40. VA HJR 148.  See also VA HJR 573. 

41. LA House Current Resolution (HCR) 29.

42. AL HB 9; AL SB 314; AZ HB 2108; CA SB 133; CA AB 267; CA SB 1557; CO HB 1073; CT SB 407; CT HB 5639; CT SB 410; DE SB 55; DE SB 329; DE SB 344; FL HB 285; FL SB 1726; FL HB 805; FL SB 1164; IL HB 253; IN HB 1538; IN HB 1984; IN SB 151; IN SB 138; KS HB 2736; KY HB 138; KY HB 153; KY HB 265; LA HB 472; LA HB 1810; MA HB 1280; MA HB 3125; MA HB 2048; MA HB 2052; MA SB 1917; MO HB 163; MO HB 209; MO HB 1449; MO SB 191; NE LB 602; NE LB 1067; NH HB 1464; NJ AB 2040; NJ AB 2840; NJ AB 1379; NJ SB 542; NY AB 1819; NY AB 3295; NY AB 4533; NY AB 6249; NY SB 206; NY SB 7638; NY SB 612; NY SB 3013; OK HB 1130; OK HB 2011; OK HB 2036; OK HB 2142; OK SB 1552; OR HB 2538; OR HB 2504; SC HB 3819; SC HB 4408; SC SB 820; TN HB 1075; TN SB 1515; TN HB 2675; TN SB 2295; TX HB 1175; TX SB 1034; TX SB 156; VT HB 326; WA HB 1461; WA SB 5466; WA HB 2173; WA SB 5571; WV HB 2832; WV SB 402; WV SB 514; WI AB 104; WI AB 246; WI SB 45; WI SB 699; WI AB 736; WI SB 404. 

43. NJ AB 2040.

44. See, for example, IN HB 1538 § 1; IN SB 151 § 1.a; MO HB 163 § 565.305; TN HB 1075 § 1; TN SB 1515 § 1.

45. Unless, of course, one used an egg from the to-be-cloned person's own mother.

46. See, for example, CA SB 133 § 1; FL SB 1726 § 2.A; KY HB 153 § 1.A; NE LB 602 § 2.2; OK HB 1130 § C.1; SC SB 820 § 2.1; SC HB 3819 §2.1; WI SB 45 § 1.c; WI AB 104 § 1.c.

47. See, for example, DE SB 55 § 3002; IL HB 253 § 10.c; NH HB 1464 § 141-J:2; NY SB 206 § 3230; NY SB 7638 § 3230; OR HB 2538 § 1.

48. See Robert Lee Hotz, "Cow Eggs Used as Incubator in Cloning Boon," L.A. Times, Jan. 19, 1998, at A1.

49. See, for example, CA SB 133 § 1.

50. NJ AB 2040 (1).  See also MA HB 3125 § 2A.

51. NJ AB 2040 (2)(c).

52. IN HB 1538; IN HB 1984; IN SB 138; IN SB 151; LA HB 472; MS SB 2747; MO HB 481; MO SB 191; MO HB 163; NY AB 4533; OK HB 1130.

53. See, for example, CA SB 133. 

54. See, for example, CO HB 1073; FL SB 1726; KY HB 153; OK HB 1130; SC HB 820; SC HB 3819; WI SB 45; WI AB 104.

55. FL SB 1726.

56. AL HB 9; AZ HB 2108; CA SB 133; CA SB 1557; DE SB 55 § 3003; DE SB 329; DE SB 344; FL HB 285; FL HB 805; FL SB 1164; FL SB 1726 § 5; IL HB 253; KS HB 2736; KY HB 138; KY HB 153 § 3; LA HB 1810; MA HB 2048; MA HB 3125; NE LB 1067; NH HB 1464 § 1441-J:4; NY AB 3295; NY AB 6249 § 2; NY SB 206 § 3232; NY SB 7638 § 3232; NY SB 3013; OK HB 2142; SC HB 3819 § E; SC SB 820; TN HB 1075 § e; TN SB 1515 § e; TX HB 1175; WA HB 1461; WA HB 2173; WA SB 5466.

57. AZ HB 2108; IN HB 1538; IN HB 1984; IN SB 138; IN SB 151; KS HB 2737; LA HB 1810; NH HB 1464 § 1441-J:4;  NY AB 6249 § 2; NY SB 206 § 3232; NY SB 7638 § 3232; NY SB 612; NY SB 3013; OK HB 2142; OR HB 2538 § 2; VA HB 2366; WA HB 2173; WI AB 736; WI SB 404.

58. AL HB 9; AZ HB 2108; CA SB 133; CA SB 1557; CO HB 1073; CT SB 407; CT HB 5639; DE SB 55; FL HB 805; FL SB 1164; FL SB 1726; IL HB 253; IN HB 1538; IN HB 1984;  IN SB 151; IN SB 138; KS HB 2736; KY HB 138; KY HB 153; LA HB 1810; MA HB 3125; MO HB 1449; NE LB 602; NH HB 1464; NJ AB 2040; NY AB 4533; NY AB 6249; NY SB 206; NY SB 3013; NY SB 7638; OK HB 1130; OK HB 2011; OK HB 2142; OK SB 1552; OR HB 2538; SC HB 3819; SC SB 820; SC HB 4408; TN HB 1075; TN SB 1515; TX HB 1175; TX SB 156; WA HB 2173; WA SB 5571; WV HB 2832; WV SB 402; WV SB 514.; WI SB 699; WI AB 104; WI AB 736; WI SB 404; WI SB 45.  (Therapeutic cloning, as currently undertaken, would also fall within the ban on destructive embryo research discussed infra.)

59. See, for example, Indiana and New York.

60. AL HB 9; AZ HB 2108; CA SB 133; CA SB 1557; CO HB 1073; CT SB 407; CT HB 5639; DE SB 55; FL HB 805; FL SB 1164; FL SB 1726; IL HB 253; IN HB 1538; IN SB 151; IN SB 138; KS HB 2736; KY HB 138; KY HB 153; LA HB 1810; MA HB 3125; MO HB 1449; NE LB 602; NH HB 1464; NJ AB 2040; NY AB 4533; NY SB 206; NY SB 7638; OK HB 1130; OK HB 2011; OK HB 2142; OK SB 1552; OR HB 2538; SC HB 3819; SC SB 820; SC HB 4408; TN HB 1075; TN SB 1515; TX HB 1175; TX SB 156; WA HB 2173; WA SB 5571; WV HB 2832; WV SB 402; WV SB 514; WI AB 104; WI SB 699; WI AB 736; WI SB 404; WI SB 45.

61. See, for example, FL SB 1726.

62. See, for example, NE LB 602.

63. IN HB 1984; NY AB 6249; NY SB 3013.

64. MA HB 1280; MA HB 2052; NJ AB 2840; NJ SB 1909; NY AB 1819; NY SB 612; TX SB 1034; VT HB 326; WA HB 1461; WA SB 5466.

65. LA HCR 29A.

66. MI HR 189.

67. KS HB 2737; MI HB 4507; NJ AB 2040; VA HB 2366; WI AB 736; WI SB 404.

68. NJ AB 2040; WI AB 736; WI SB 404.

69. KS HB 2737; MI HB 4507; VA HB 2366.

70. VA HB 1361.

71. MI HR 189. 

72. MI HR 189.

73. CA SB 771; CA SB 1272; IL HB 3589; MD HB 482; MA HB 2052; MA HB 1280; NJ AB 2840; NJ SB 1909; NY AB 1819; NY SB 612; PA HB 2984; PA HB 422; PA HB 945 (Limited to those from fertility clinics); RI SB 266; TN HB 945; TN SB 1654; TX SB 1034; VT HB 326; WA HB 1461; WA SB 5466.

74. See, for example, IL HB 3589 § 10.2.

75. CA SB 771; CA SB 1272; IL HB 3589 (does not require Dr. to inform patient of embryo disposition options, but requires written informed consent); MA HB 2052; MA HB 1280; NJ AB 2840; NJ SB 1909; NY AB 1819; PA HB 2984; PA HB 422; PA HB 945 (Does not require Dr. to inform patient of embryo disposition options, but requires written informed consent); RI SB 266; TN HB 945; TN SB 1654; TX SB 1034; VT HB 326; WA HB 1461; WA SB 5466.

76. PA HB 2984; PA HB 422.

77. CA SB 322; CA SB 771; CA SB 1272; IL HB 3589; MD HB 482; MA HB 1280; MA HB 2052; NJ AB 2840; NJ SB 1909; NY AB 1819; RI SB 266; TN HB 945; TN SB 1654; TX SB 1034; VT HB 326; VA HB 639.

78.  KY HB 265.

79. CA SB 771.

80.  IL HB 3589.

81. CA SB 771; CA SB 1272; IL HB 3589 § 15; MD HB 482 § 20-901.C;  MA HB 1280 § 3; MA HB 2052; NJ AB 2840 § 2.b.3; NJ SB 1909 § 2.b.2; NY AB 1819 § 2452.2; PA HB 2984 § 5.b; PA HB 422 § 5.b; PA HB 945; RI SB 266 § 23-77-2; TN HB 945; TN SB 1654; TX SB 1034 § 168.003; VT HB 326 § 9341.B; WA HB 1461§ 4; WA SB 5466 § 4.1.

82. CA SB 771; CA SB 1272; IL HB 3589 § 15a; IN HB 1538; IN SB 138; IN SB 151; MD HB 482 § 20-901; MA HB 1280; MA HB 2052; NJ AB 2840 § c.1; NJ SB 1909 § c.1; NY AB 1819 § 2453; PA HB 2984 § 6; PA HB 422 § 6; PA HB 945; TN HB 945; TN SB 1654; VT HB 326 § 9342; VA HB 2366 (If used in destructive research); WA HB 1461 § 5.2; WA SB 5466 § 5.2.

83. CA SB 322; CA SB 771 (State department to oversee ESC research); MD HB 72 (Task force would cover bioscience in general, including ESC research); MD HB 1171; MA HB 1280 § 220; MA HB 2052; NY AB 6249 § 4372; NY SB 3013; PA HB 422 § 4; PA HB 2984 § 4; VA HJR 148; VA HJR 573; VA HB 639 (Task force would cover all human research in general, including ESC).

84. See, for example, California, Maryland, and Virginia.

85. See, for example, Illinois, Maryland, Massachusetts, New Jersey, New York, Pennsylvania, Rhode Island, Texas, and Vermont.

86. MD HB 72; MD HB 1171.

87. This was the case, for example, with newborn screening and surrogate motherhood.

88. MD HB 1171.

89. CA SB 778.

90. IN HB 1001; MI SB 1485; MI HB 4454; MS HB 361; MS SB 2747.

91. FL SB 2212; FL SB 572; FL SB 2390; FL HB 107A; FL HB 845; FL SB 2142.

92. KS HB 2711; LA SB 850; RI SB 906; RI HB 5846.

93. 735 F. Supp. 1361 (N.D. Ill. 1990).

94. Id. at 1364.  The court also held that the statute violated couples' right to privacy to make reproductive decisions to undertake preimplantation genetic screening, or procreate with a donated embryo.  Id. at 1377.  With embryo stem cell research, the progenitors' reproductive freedom is not an issue, however.

95. Id. at 1364-65.

96. Id. at 1364.

97. Margaret S. v. Edwards, 794 F.2d 994 (5th Cir. 1986).

98. Id. at 999.

99. Id.

100. Id. A concurring judge found this analysis to be contrived and opined that the provision was not unconstitutionally vague.  Id. at 1000 (Williams, J., concurring).  Instead, he suggested that the prohibition was unconstitutional because "under the guise of police regulation the state has actually undertaken to discourage constitutionally privileged induced abortions."  Id. at 1002, citing Thornburgh v. American College of Obstetricians and Gynecologists, 106 S. Ct. 2169, 2178 (1986).  The concurring judge pointed out that the state had "failed to establish that tissue derived from an induced abortion presents a greater threat to public health or other public concerns than the tissue of human corpses [upon which experimentation is allowed]."  Id.  Moreover, the state had not shown a rational justification for prohibiting experimentation on fetal tissue from an induced abortion, rather than a spontaneous one.  Id.

101. Margaret S. v. Edwards, 794 F.2d 994, 999 (5th Cir. 1986).

102. Id.

103. Utah Code Ann. § 76-7.3-310.

104. Jane L. v. Bangerter, 61 F.3d 1493, 1501 (10th Cir.), rev'd on other grounds sub nom., Leavitt v. Jane L., 518 U.S. 137 (1996).

105. 2000 U.S. App. LEXIS 38596 (9th Cir. 2000).

106. Plaintiffs include numerous doctors and individuals suffering from Parkinson's disease who cannot receive transplants of fetal brain tissue because of the statute.

107. 2000 U.S. App. LEXIS 38596 (9th Cir. 2000).

108. A.R.S. § 36-2302(A)(2000).

109. A.R.S. § 36-2302(C)(2000).

110. See A.R.S. § 36-2303(2000).

111. 2000 U.S. App. LEXIS 38596, *5 (2000).

112. Forbes v. Woods, 71 F. Supp.2d 1015, 1999 U.S. Dist. LEXIS 17025 (1999).

113. 2000 U.S. App. LEXIS 38596, *12 (9th Cir. 2000).

114. 2000 U.S. App. LEXIS 38596, *11 (9th Cir. 2000).  The court determined that the "knowingly" scienter requirement within the statute did not serve as a clarification for the distinction.

115. 2000 U.S. App. LEXIS 38596, *12 (2000).

* * *

 

 

Chart I
State Cloning Legislation

State
Reproductive cloning ban
"Therapeutic" cloning ban
Prohibition of State Funds
Permanant ban
Definition of "cloning"
Arkansas
Ark. Code §20-16-1001 et. seq.
x
x
x
Asexual human reproduction, accomplished by introducing the genetic material from one or more human somatic cells into a fertilized or unfertilized oocyte whose nuclear material has been removed or inactivated so as to produce a living organism, at any stage of development, that is genetically virtually identical to an existing or previously existing human organism
CaliforniaCal. Bus. & Prof. §16004, 16105; Cal. Health & Safety §§24185-24187 (2003)
x
x
Nucleus transfer from a human cell from whatever source into a human or nonhuman egg cell from which the nucleus has been removed for the purpose of, or to implant, the resulting product to initiate a pregnancy that could result in the birth of a human being.
Iowa
Iowa Code §707B.1-.4 (2003)
x
x
x
Human asexual reproduction, accomplished by introducing the genetic material of a human somatic cell into a fertilized or unfertilized oocyte whose nucleus has been or will be removed or inactivated, to produce a living organism with a human or predominantly human genetic constitution
Louisiana
La. Rev. Stat. Ann. §1299.36.1-.6 (2003)Sunset Provision: July 1, 2003
X
Does not prohibit use of state funds for scientific research or cell-based therapies that do not involve human cloning
X
Identical to California
Michigan
Mich. Comp. Laws §§333.26401-06, 333.16274, 16275, 20197, 750.430a (2003)
X
X
X
X
Use of human somatic cell nuclear transfer technology (transferring the nucleus of a human somatic cell into an egg from which the nucleus has been removed or rendered inert) to produce a human embryo
Missouri
Mo. Rev. Stat. §1.217 (2003)
X
X
Replication of a human person by taking a cell with genetic material and cultivating such cell through the egg, embryo, fetal and newborn stages of development into a new human person
North Dakota
N.D. Cent. Code §§12.1-39-01-02 (2003)
X
X
X
Human asexual reproduction, accomplished by introducing the genetic material of a human somatic cell into a fertilized or unfertilized oocyte, the nucleus of which has been or will be removed or inactivated, to produce a living organism with a human or predominantly human genetic constitution
Rhode Island
R.I. Gen. Laws §23-16.4-1 -.4-4 (2003)Sunset provision: July 7, 2010
X
Cell transfer and other cloning technologies not included in ban; mitochondrial, cytoplasmic and gene therapy not prohibited for research or animal creation
Use of somatic cell nuclear transfer for pregnancy prohibited (transferring the nucleus of a human somatic cell into an oocyte from which the nucleus has been removed).
Virginia
Va. Code Ann. §32.1-162.21-.22 (2003)
X
X
Transferring the nucleus from a human cell from whatever source into an oocyte from which the nucleus has been removed or rendered inert in order to create a human being

 

Chart II
Laws and 2002-2003 Bills

State Prohibit All Human Cloning (including therapeutic) Prohibit Reproductive Cloning Allow Therapeutic Cloning Specifically Ban Destructive Embryo Research Allow Embryo Stem Cell Research
AL X        
AZ X X      
AR Law Law      
CA X XLaw     XLaw
CO X X      
CT X X      
DE X X      
FL X X      
GA          
HI          
ID          
IL X X     X
IN X X X    
IA Law Law   Law  
KS X X   X  
KY X X      
LA X XLaw      
ME         X
MD          
MA X X     X
MI Law Law   X  
MN          
MS          
MO X X      
MT          
NE X X      
NV          
NH X X      
NJ X X   X X
NM          
NY X X X   X
NC          
ND Law Law      
OH          
OK X X      
OR X X      
PA         X
RI   Law     X
SC X X      
SD          
TN X X     X
TX X X     X
UT          
VT   X     X
VA   Law   X X
WA X X      
WV X X      
WI X X   X  
WY          

*The Laws that have already been enacted are indicated by the word "Law"
*The bills are indicated by an "X"

 

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