1 In this Article genetic enhancement is defined as any genetic manipulation or engineering that is not aimed at correcting a disease. In contrast, gene therapy is a genetic manipulation performed only with the therapeutic intent of correcting a genetic disease. Our definition of GE does not include “passive” GE such as genetic testing and selective abortion. While “passive” forms of GE may also be of concern, they do not raise the same issues that “active” GE does because these techniques do not change or manipulate a natural set of DNA; they merely allow one to chose between two natural sets of DNA. For more information about the distinction between GE and gene therapy, see generally Leroy Walters & Julie G. Palmer, The Ethics of Human Gene Therapy (1997); see also Eric T. Juengst, What Does Enhancement Mean?, in Enhancing Human Capacities: Conceptual Complexities and Ethical Implications (Eric Parens ed., 1998); Eric T. Juengst, Can Enhancement Be Distinguished from Prevention in Genetic Medicine?, 22 J. Med. & Phil. 125, 125-42 (1997).

2 For a more complete discussion of these social concerns, see generally Maxwell J. Mehlman, The Law of Above Averages: Leveling the New Genetic Enhancement Playing Field, 85 Iowa L. Rev. 517 (2000); Maxwell J. Mehlman, How Will We Regulate Genetic Enhancement?, 34 Wake Forest L. Rev. 671 (1999).

3 This program was to be voluntarily implemented by interested states. Implementation of the Fertility Clinic Success Rate and Certification Act of 1992—A Model Program for the Certification of Embryo Laboratories, 64 Fed. Reg. 39,374 (July 21, 1999). The act set forth model certification program requirements for the laboratory and administrative workings of fertility clinics. These requirements were intended to provide the public with a means of comparing efficacy and quality success rates at participating clinics in participating states. Id.

4 See Andrews, Lori & Elster, Nanette, International Regulation of Human Embryo Research: Embryo Research in the US, 13 Human Reproduction 1 (1998)CrossRefGoogle Scholar.

5 See Memorandum on the Prohibition on Federal Funding for Cloning of Human Beings, 33 Weekly Comp. Pres. Doc. 281 (Mar. 4, 1997).

6 McGinley, Laurie et. al., Bush to Allow Limited Stem-Cell Funding: President Would Support 60 Established Lines, Seeking Middle Ground, Wall Street J., Aug. 10, 2001, at A3Google Scholar.

7 For an overview of these state statutes and some of the resulting litigation, see generally Andrews & Elster, supra note 4.

8 On November 3, 1999, the Department of Health and Human Services (DHHS) published a draft guidance document on the use and manufacture of gene therapy retroviral vector products intended for use in patients and on the follow-up procedures used to monitor patients' progress. Draft “Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors;” Availability, 64 Fed. Reg. 59,783 (Nov. 3, 1999). A few months later, DHHS published a notice that the Recombinant DNA Advisory Committee (RAC) would be considering a request that the National Institutes of Health (NIH) place a moratorium on some types of human somatic gene therapy protocols using viral vectors. Office of Biotechnology Activities, Recombinant DNA Research: Notice, 65 Fed. Reg. 8, 618 (2000).

9 Fischer, Joannie, The First Clone, U.S. News & World Rep., Dec. 3, 2001, at 50Google Scholar.

10 Senators Richard Shelby, a Republican from Alabama, and Patrick Leahy, a Democrat from Vermont, both agreed that the Senate would not allow the cloning of human embryos to continue. MSNBC.Com, Human Embryo Cloning Draws Fire (Nov. 26, 2001), at http://www.msnbc.com/news/662735.asp.

11 Gibbs, Nancy, Baby, It's you! And You, and You . . ., Time, Feb. 19, 2001, at 47Google Scholar.

12 CNN.com, Team to Attempt Human Cloning (Mar. 9, 2001), available at http://www.cnn.com/2001/WORLD/europe/03/09/clone/index.html. In early April 2002 there were reports that the pair had a patient who was eight weeks pregnant with a human clone. The location of the cloning clinic remains undisclosed. For more information see Raja Mishra, Human Clone on Way, Says Scientist on Project (Apr. 6, 2002), available at http://www.bayarea.com/mld/mercurynews/ world/3011670.htm.

13 U.S. Census Bureau, Current Population Reports: Consumer Income, Money Income in the United States: 2000 1 (2001), available at http://www.census.gov/hhes/www/ income00.html.

14 Guzick, D.S. et al., Efficacy of Treatment for Unexplained Infertility, 70 Fertility & Sterility 207, 208 (1998)CrossRefGoogle Scholar.

15 IVF is fairly common. In 1999 approximately 86,822 artificial reproduction technology (ART) cycles, at least seventy-five percent of which were IVF cycles, were performed at reporting clinics. U.S. Dep't of Health & Human Servs., Ctrs. For Disease Control & Prevention, 1999 Assisted Reproductive Technology Success Rates 11 (2001), available at http://www.cdc.gov/nccdphp/drh/ART99/index99.htm.

16 This is because mtDNA is contained in mitochondria, which reside in the cytoplasm of cells such as the enucleated egg. Thomas D. Gelehrter Et. Al., Principles of Medical Genetics 40-42 (2d ed. 1998). However, the nucleus added to the enucleated egg during the cloning process has no mitochondria, and therefore, no mtDNA. Therefore, any clone produced would have the mtDNA of the egg donor and not the person being cloned.

17 An exception to this assertion is evidence suggesting that reproducing clones are more likely to pass along faulty genes or “older” DNA. This result is suggested by shortened telomere length in cloned animals' DNA making them genetically “older” than they are in actual years. The effects of this noted phenomenon are unknown on reproduction or on the clones. Nat'l Bioethics Advisory Comm'n, Cloning Human Beings 24 (1997), available at http://bioethics. georgetown.edu/nbac/pubs. html.

18 This is presuming that GE is effective.

19 See UNESCO, Universal Declaration on the Human Genome and Human Rights, 29th Sess., 29 C/Res. 16 (1997), available at http://www.unesco.org/human_rights/hrbc.htm. The declaration was adopted by the general assembly in 1999. G.A. Res. 152, U.N. GAOR, 53rd Sess., U.N. Doc. A/53/152 (1999).

20 In addition, GE is not victimless. GE not only harms or puts the enhanced individual at risk, but it harms fellow citizens by putting them at a disadvantage.

21 Maxwell J. Mehlman, How Will We Regulate Genetic Enhancement?, 34 Wake Forest L. Rev. 671, 681 (1999).

22 For a Hollywood rendering of this scenario, seeGattica (Sony Pictures 1997).

23 U.S. Cong., Office Tech. Assessment, OTA-BP-BA-32, Human Gene Therapy: Background Paper 43 (1984) [hereinafter Human Gene Therapy].

24 Id. at 34.

25 See Universal Declaration on the Human Genome and Human Rights, supra note 19, art. I.

26 Id. art. 2(a). It seems that a basic right such as this might be grounded in the traditional notion of a liberty interest. This could be defined as an extension of the liberty interests that the Constitution already recognizes. It could also come from an interest in bodily integrity or reproductive liberty, which are new additions to constitutional thinking.

27 Id. art. 2(b).

28 President's Comm. for the Study of Ethical Problems in Med. and Biomedical and Behavioral Research, Splicing Life: A Report on the Social and Ethical Issues of Genetic Engineering With Human Beings, 64-65 (1982).

29 The Universal Declaration of the Human Genome and Human Rights states that “[ejvery individual shall have the right, according to international and national law, to just reparation for damage sustained as a direct and determining result of an intervention affecting his or her genome.” Universal Declaration on the Human Genome and Human Rights, supra note 21, art. 8. This language, if adopted in the United States, would give children that are genetically enhanced a cause of action against their parents unless the courts determine that parents, as guardians of their children, are immune from suit. The choices that parents make concerning their child's genetic makeup might even be considered the equivalent of child abuse.

30 The easy way to address safety and efficacy concerns is to rely on the regulations promulgated by the Food and Drug Administration (FDA). See infra discussion at Part IV.A.

31 Some scholars disagree, contending that GE will not have a large effect on the genome. Jon W. Gordon, Genetic Enhancement in Humans, 283 Science 2023, 2023-24 (1999). Jon Gordon writes:

Id. at 2024. While a very interesting analysis of the situation, the author does not considr a situation where scientists have perfected gene transfers. Also, the author fails to consider a situation where the people receiving the gene transfers are of a select population, either by the force of a crazed leader or by coincidence. For example, if the richest twenty percent of Americans purchase gene transfers and then only allow their children to marry other enhanced children, a significant change in the genome could occur.

32 For a more detailed discussion of the differences between germline and somatic cell gene therapy, see Gelehrter, supra note 16, at 311-28; Peter J. Russell, Genetics 496-97 (4th ed. 1996).

33 Saltus, Richard, Are We Getting Closer to Cloning Humans?, Boston Globe, Sept. 5, 2000, at CIGoogle Scholar.

34 Gibbs, supra note 11, at 48.

35 “It shall be unlawful for any person to knowingly acquire, receive or otherwise transfer any human organ for any valuable consideration for use in human transplantation if the transfer affects interstate commerce.” A fine up to $50,000 and/or imprisonment for up to five years penalizes a person caught breaking the statute. 42 U.S.C.A. § 274e (2001).

36 Altman, Jason, Organ Transplantations: The Need for an International Open Organ Market, 5 Touro Int'l L. Rev. 161, 172 (1994)Google Scholar. The author cites serious infections, hepatitis, AIDS and high death rates of both donors and patients as some of the problems associated with getting transplants in third-world countries. See also A. Rizvi & A. Naqui, Current Issues and Future Problems in Transplantation in East Asia, 33 Transplantation Proceedings 2623 (2001). These authors cite economic factors and a poor medical infrastructure as serious problems. For instance, in developing countries forty-three percent of deaths are due to infections, while in developed countries only one percent of deaths are due to infection. Id. at 2624.

37 Christian Williams, Note, Combating the Problems of Human Rights Abuses and Inadequate Organ Supply Through Presumed Donative Consent, 26 Case W. Res. J. Int'l L. 315, 322 (1994).

38 Curtis A. Kin, Note, Coming Soon to the “Genetic Supermarket” Near You, 48 Stan. L. Rev. 1573 (July 1996).

39 Malinowski, Michael J., Globalization of Biotechnology and the Public Health Challenges Accompanying It, 60 Alb. L. Rev. 119, 159 (1996)Google Scholar. However, this author states that the FDA has relaxed its standards and is moving toward harmonization, allowing some drugs to be approved solely on the basis of foreign clinical data.

40 Human Gene Therapy, supra note 23, at 45 (Dec. 1984).

41 Id.

42 Dr. Cline resigned as division chairman and was sanctioned by the Department of Health after a NIH report reviewing his actions condemned them. Id. at 45-46. For all future experiments, he was required to submit an assurance of compliance with human subject safeguards, obtain not only local IRB review, but also NIH review of all recombinant DNA experiments, and include the NIH report of these incidents in all new NIH applications for grant monies. These sanctions were to remain in effect until 1984 and effectively ended his career. Id.

43 For example, theUniversal Declaration on the Human Genome and Human Rights suggests what states “should” do. Section G, article 22, Implementation of the Declaration, states that “[s]tates should make every effort to promote the principles set out in this Declaration and should, by means of all appropriate measures, promote their implementation.” Universal Declaration on the Human Genome and Human Rights, supra note 19, § G, art. 22. The actual resolution implementing the declaration “[u]rges Member States . . . to take appropriate steps, including the introduction of legislation or regulations, to promote the principles set forth in the Declaration, and to promote their implementation.” (emphasis in original). U.N.E.S.C.O., Resolution Adopted by the Twenty-Ninth Session of the General Conference: Implementation of the Universal Declaration on the Human Genome and Human Rights 29th Sess., C/Res. 17, § 1 (1997), available at http://www.unesco.org/ibc/en/genome/ res29.html.

There are no mechanisms for enforcement stated in either the declaration or the resolution. All of the international resolutions dealing with human rights and biotechnologies are structured this way. In addition, “[u]nder Chapter VII of the United Nations Charter, the Security Council can take enforcement measures to maintain or restore international peace and security. Such measures range from economic sanctions to international military action.” U.N., Dept. Public Info., Basic Facts About the United Nations 76 (1998). However, these measures are only used when “peace [is] threatened and diplomatic efforts [have] failed.” Id.

44 The International Court of Justice has jurisdiction over questions referred to it, matters provided for in the Charter (GE is not one of these matters), or over issues covered by treaties and conventions in force. But a state's actions cannot be referred to the International Court of Justice unless the state either signs a treaty or convention and it contains a clause referring disputes to the court, or the state makes a declaration granting the court jurisdiction over it in regard to certain matters. Id. at 14. Therefore, the United Nations can pass a thousand declarations or treaties regulating GE , but such documents are not binding on the member nations unless they sign. In addition, even if states refuse to sign the declaration but agree to implement some or all of the suggested provisions in their national laws, they can simply change their minds by giving the appropriate U.N. official sixty days' notice that they are revoking that section of their national law. This probably explains why the United States often refuses to sign conventions, declarations and treaties that other member states sign even if the United States was an active participant in the document's creation.

45 Countries like the United Kingdom tend to be more concerned about biotechnology. The United Kingdom was one of the first countries to create detailed procedures and rules for IVF. They were also one of the first countries to raise concerns about genetically modified foods.

46 Meredith Wadman, Germline Gene Therapy Must Be Spared Excessive Regulation, 392 Nature 317 (1998). Implicit in the intent to regulate gene therapy is the intent to regulate GE, which many Europeans consider a morally worse biotechnology because its purpose is to enhance, not to cure.

In 1996, the European Parliament passed a resolution banning any manipulation of the human genome that modifies or seeks to modify the germline. Resolution on the Protection of Human Rights and Dignity With Regard to the Application of Biology and Medicine, Oct.28, 1996, O.J. (C 320) (1996). Typical of European national laws is French law, which forbids any attempt to alter genetic characteristics with the intent to modify the germline and has a penalty of up to twenty years for trying. Law No. 94-653 of July 29, 1994, J.O., July 30, 1994, No. 175 at 11056-59, art. 16(3), (10), reprinted in 45 Int'l Dig. Of Health Legis. 453, 498 (1994).

47 Gordon, supra note 34, at 2024.

48 See generally Federal Food, Drug and Cosmetic Act 21 U.S.C.A. §§ 301-397 (West 2001) [hereinafter FDCA].

49 For instance, when Richard Seed proposed human cloning clinics in the United States there was a huge public outcry. According to the Los Angeles Times, the FDA, in response to Seed's proposal, decided it had the authority to regulate human cloning. People wishing to set up a clinic in the United States are now required to file a formal application with the FDA. The FDA then reviews the application, via a lengthy review process, and either approves or disapproves of the clinic. The FDA threatened legal action against any person or entity setting up a clinic without filing a formal application. Times Wire Servs., FDA Warns Against Human Cloning Attempt, L.A. Times, Jan. 20, 1998, at B8. Approval of either a cloning or GE clinic would be costly, time-consuming and highly unlikely.

50 The FDCA defines “drug” to mean “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and articles (other than food) intended to affect the structure or any function of the body of man or other animals.” 21 U.S.C. § 321(g)(1)(b).

51 The FDCA defines “device” to mean:

21 U.S.C. § 321(h), (2)-(3).

52 In order to get a GE drug or device on the market in the United States, the drug or device would have to be approved pursuant to New Drug Application procedures which are strict and time consuming. The FDA could refuse New Drug Applications for a variety of reasons including safety, lack of testing, poor packaging or manufacturing, lack of evidence the drug will have its effect and false or misleading labeling. 21 U.S.C. § 355.

53 The introduction or delivery for introduction into interstate commerce of any article in violation of the New Drug Application procedure is considered a violation of the FDCA. 21 U.S.C. § 331(d). When a violation occurs the FDA can get an injunction in a court. 21 U.S.C. § 332. Violating an injunction results in criminal penalties. Id. Also, violators of the New Drug regulations are subject to both civil fines and jail time. 21 U.S.C. § 333.

54

Legal Status of Approved Labeling For Prescription Drugs; Prescribing For Uses Unapproved By The Food And Drug Administration: Notice of Proposed Rule Making, 37 Fed. Reg. 16, 503, 16, 503-04 (Aug. 15, 1972). See also Peter Barton Hutt & Richard A. Merrill, Food and Drug Law 617 (2d ed. 1991).

55 Kin, supra note 38, at 1584.

56 Id. at 1590.

57 For instance, when Dr. Martin Cline attempted to treat two patients using unapproved recombinant DNA gene therapy in 1980, the NIH terminated his grants. Human Gene Therapy, supra note 23, at 45 (1984). In an attempt to prevent Dr. Cline from conducting any more premature and unethical experiments, the NIH also “added several requirements, including the need to submit an assurance of the compliance with human subjects safeguards, prior review by the local IBC and NIH of all recombinant DNA experiments, and inclusion of the NIH report to the events to the review groups for his subsequent new applications for NIH grants.” Id. These sanctions were rendered against Dr. Cline by the DHHS but were based on NIH review. Id. at 46. At the time, many believed that the sanctions were harsh because they made his prospect for future grants, without which he could not get money for research, very poor. However, if the government is serious about preventing GE, it might impose even stricter sanctions such as rendering physicians and researchers unable to obtain any federal monies for the rest of their lives, thereby ending their careers.

58 42 U.S.C. § 262(b) (1994).

59 For example, the Balanced Budget Downpayment Act of 1996 prohibits any NIH funding for FY 1996 (contained in P.L. 104-91) from being used for:

Balanced Budget Downpayment Act, Pub. L. No. 104-99, § 128 110 Stat. 26, 34 (1996).

60 In 1994, President Clinton directed the NIH not to allocate any resources toward the creation of human embryos for research purposes. Statement on Federal Funding of Research on Human Embryos, 30 Weekly Comp. Pres. Doc. 2459. In 1998, Clinton banned the use of federal funds for the cloning of human beings. The President's Radio Address, 34 Weekly Comp. Pres. Doc 46 (Jan. 10, 1998).

61 Most research facilities in the United States receive federal funding. 62 However, this reduces federal oversight of private research and enables private companies, rather than the public, to monopolize the value from GE discoveries.

63 See Memorandum on the Prohibition on Federal Funding for Cloning of Human Beings, supra note 5, at 281; see also McGinley et. al., supra note 6, at A3.

64 OnMeet the Press, Dr. Michael West, President and CEO of Advanced Cell Technology (the first firm to create a cloned human embryo), Senator Richard Shelby and Senator Patrick Leahy all agreed that if Congress bans the cloning of human embryos in the United States firms may move to other countries. Senator Shelby stated, “Well, I believe it will go on somewhere, perhaps outside, if it's banned here, because I think science just continues to progress in certain ways, whether we like it or not, whether we agree with it or not.” NBC News, Meet the Press (NBC television broadcast, Nov. 25, 2001).

65 For example, some couples with an HIV positive male spouse have probably traveled to foreign countries in an attempt to access a sperm spinning technique called sperm washing that allegedly reduces the risk of HIV infection for the non-infected female spouse. In this procedure a male who is HIV positive has his sperm “washed” to remove as much of the virus as possible before the sperm is joined with his HIV negative partner's egg. Then the newly created embryo is placed in the women's womb. The purpose of this procedure is to reduce the risk of transmission to both the mother and the baby. Many state statutes seemingly prohibit this procedure because it is illegal to knowingly transfer HIV infected tissue and blood to another person. See, e.g., Ga. Code Ann. § 16-5-60 (2001); Idaho Code § 39-601 (Michie 2000); Mo. Ann. Stat. § 191.677 (West 2001); Okla. Stat. Ann. tit. 21, § 1192.1 (West 2001). However, many European countries, such as Italy, allow the technique to be perforMed. Carole Gilling-Smith et al., HIV and Infertility: Time to Treat, 322 Brit. Med. J. 566, 567 (2001). Therefore, some of these couples have likely gone abroad to access sperm washing procedures without fear of criminal prosecution. While this scenario seems analogous to the GE case, it may not be because there is an affirmative defense of consent allowed under the state statutes. In the sperm washing procedure, it can be assumed that the woman receiving the possibly HIV-infected material is consenting to the process as the sperm donor is usually her husband. GE regulations probably would not allow the affirmative defense of informed consent because GE is perceived as harming society in an abstract sense whereas a woman taking the risk of contracting HIV via the sperm washing procedures is taking a risk upon herself that has few detrimental societal effects (assuming the child is HIV negative or that if the child become HIV positive that the state will not have the burden of caring for the child.)

66 See, e.g., United States v. Greer, 956 F. Supp. 531 (D. Vt. 1997). In this drug enforcement action, the district court for the District of Vermont held that Congress did have the authority to give extraterritorial effect to the Maritime Drug Law Enforcement Act with respect to U.S. citizens who were violating the law in international waters. Id. at 536.

67 See, e.g., United States v. Bowman, 260 U.S. 94 (1922). In this conspiracy to defraud the government case, the U.S. Supreme Court held that the issue of constitutionality was one of statutory construction, and that as long as Congress expressed its intent to have the laws apply abroad, it could do so. Id. at 97-99. See also Blackmer v. United States, 284 U.S. 421 (1932).

68 A U.S. citizen commits treason if he or she levies war against the United States, adheres to the United States' enemies or gives them aid and comfort. The punishment for treason is death or imprisonment not less than five years and a fine not less than $10,000. In addition, the citizen becomes incapable of holding any office under the United States. 18 U.S.C. § 2381 (1994). Treason can be committed by American citizen even if he is living beyond territorial limits of the United States. See, e.g., Tomoya Kawakita v. United States, 343 U.S. 717 (1952). Treason can also be committed by a U.S. citizen residing in enemy territory. See, e.g., Burgman v. United States, 188 F.2d 637 (D.C. Cir. 1951).

18 U.S.C. § 2381. This must be an intentional act. See Cramer v. United States, 325 U.S. 1 (1945).

70 18 U.S.C. §2381.

71 Stephan v. United States, 133 F.2d 87,89 (6th Cir. 1943).

72 There is a law that makes it illegal to transport sexually explicit pictures of children in interstate or foreign commerce, “if that visual depiction was produced using materials that have been mailed, shipped, or transported in interstate or foreign commerce by any means, including by computer, or if such visual depiction has actually been transported in interstate or foreign commerce or mailed.” 18 U.S.C. § 2251(a). However, this law does not extend U.S. jurisdiction to U.S. citizens engaging in sexual exploitation solely in foreign countries. The perpetrator must transport the requisite materials in interstate or foreign commerce.

73 See, e.g., United States v. Harvey, 2 F.3d 1318 (3d Cir. 1993).

74 Id. at 1326.

75 Id. at 1327. This holding seems to depart from the traditional notion that Congress must explicitly state that a statute has extraterritorial effect.

76 Id. at 1329.

77 Id. While not explicitly stating that this extension of jurisdiction required the occurrence of an illegal act in the United States, the court did make this suggestion. Here, the wrong act is the possession of child pornography in the United States. In the case of GE, the wrong act would be for a genetically altered patient to live as a genetically altered person in the United States. Of course Congress could make this an illegal act in and of itself. This would make it easier for the Justice Department to prosecute genetically enhanced citizens. In the case of physicians who perform GE procedures abroad, finding some element of illegal conduct within the United States is more difficult. However, physicians are likely to make contact with their American patients in the United States before the patients travel abroad. Congress could make it illegal to relay information about foreign GE clinics to American citizens or those who are likely to inform American citizens of such clinics. This would make it easier for physicians to be prosecuted. However, Harvey does not explicitly require that some illegal conduct occur in the United States for the defendant to be prosecuted for his actions abroad. Therefore, if the courts feel that the act is heinous enough, those violating a GE ban could be prosecuted anyway.

78 See, e.g., United States v. Wright-Barker, 784 F.2d 161 (3d Cir. 1986). Here, the Third Circuit held that statutes punishing both possession of a controlled substance with the intent to distribute and conspiracy to import a controlled substance fell within a narrow category of statutes that apply to acts outside the United States even though the statutes contained no explicit statement of extraterritorial jurisdiction. Id. at 167.

79 Restatement (Third) of Foreign Relations Law of the United States § 403(2) (1987).

80 “Under the [Maritime Drug Law Enforcement Act], it is unlawful for any citizen of the United States on board any vessel to knowingly or intentionally distribute, or possess with intent to distribute, a controlled substance.” United States v. Greer, 956 F. Supp. 531, 532 (D. Vt. 1997) (citing the Maritime Drug Law Enforcement Act, 46 U.S.C. app. § 1903(a) (Supp. 1996)).

81 Id. at 533 (citing United States v. Mitchell, 553 F.2d 996, 1001 (5th Cir. 1977); United States v. Black, 291 F. Supp. 262, 266 (S.D.N.Y. 1968)).

82 Id. at 533.

83 Greer, 956 F. Supp. at 536.

84 Id. (citing United States v. Caicedo, 47 F.3d 370, 372 (1995)).

85 State v. Willoughby, 892 P.2d 1319, 1325 (Ariz. 1995). “[I]n the absence of controlling federal authority, states are . . . free to choose their own rules concerning jurisdictional facts in criminal cases . ... “ Id.

86 Id.

87 Id. at 1325.

88 Id. at 1329.

89 Id. at 1330.

90 Id. at 1331.

91 Congress might be reluctant to pass GE regulations for a couple of reasons. First, if GE regulation is controversial, which it is almost certain to be, members of Congress may fear political backlash. They may pass the buck to the states in the hope minimizing political costs. Alternatively, Congress might feel that the states are good experimental sites for regulation and that a state may have a better chance of passing GE regulation if the views of the state's population are more homogenous. The federal government might also be slow at passing such regulations because its mechanisms for addressing controversial issues are slow by design. Of course, if GE is an “emergency issue” and there is a general consensus about what should be done, it is likely that the federal government would handle the issue quickly and efficiently.

92 Babies are also required to have passports. See U.S. Dep't of State, Bureau Consular Affairs, Applying for Your U.S. Passport the Easy Way, at http://travel.state.gov/passport_easy.html (last visited May 20, 2002).

93 Haig v. Agree, 453 U.S. 280, 302 (1981). The authorization for this power comes from a long line of executive orders, regulations and notices to passport holders. Id. at 298.

94 At least three cases of successful passport revocation exist. In one case a congressional member was denied a passport because he sought to travel abroad to support a movement in Greece seeking to overthrow the exiting government. In 1954 a man supplying arms to foreign groups with political positions contrary to the United States had his passport revoked. In 1970 the government revoked the passports of two Americans who wished to travel to the site of an international airplane hijacking. Id. at 302.

95 Afroyim v. Rusk, 387 U.S. 253 (1967).

96 Vance v. Terranzas, 444 U.S. 252, 270 (1988).

97 See, e.g., Thomas O'Toole, California Man Accused of Nazi Camp Role, Wash. Post, Jan. 30, 1981, at Al 8; Janet Walsh, Accused Nazi Appeals Revocation of U.S. Citizenship, United Press Int'l, Apr. 23, 1982.

98 The person who is a national of the United States by birth or naturalization shall lose his or her nationality by voluntarily (1) obtaining naturalization in a foreign state; (2) taking an oath of allegiance to a foreign state; (3) serving in the armed forces of a foreign state if such armed forces are engaged in hostilities against the United States, or serving as an officer; (4) accepting, serving in, or performing the duties of any office, post, or employment under the government of a foreign state; (5) makes a formal renunciation of their nationality; or (7) committing any act of treason or conspiring to overthrow the government of the United States. 8 U.S.C. § 1481(a) (1994). This elements of this act must be proved by a preponderance of the evidence. Id. § 1481(b).

99 Individuals can be detained for the purpose of preventing the “introduction, transmission, or spread of such communicable diseases as may be specified from time to time in Executive orders of the President upon the recommendation of the National Advisory Health Council and the Surgeon General.” 42 U.S.C. § 264(b) (1994). The most recent Executive Order lists “Cholera or suspected Cholera, Diphtheria, infectious Tuberculosis, Plague, suspected Smallpox, Yellow Fever, and suspected Viral Hemorrhagic Fevers” as quarantinable communicable diseases. Exec. Order No. 12,452, 48 Fed. Reg. 56, 927 (1983), reprinted in 42 U.S.C. § 264. The Surgeon General is allowed to issue regulations, with the approval of the President, that limit in whole or in part the entrance of people and property from countries he designates as creating a threat of communicable disease. 42 U.S.C. § 265.

100 21 U.S.C.A. §§ 801-971 (West 2001).

101 The Director of the FBI is allowed to establish an index of the following: 1) DNA identification records of persons convicted of crimes; 2) analysis of DNA samples recovered from crime scenes; 3) analysis of DNA samples recovered from unidentified human remains; and 4) analysis of DNA samples voluntarily contributed by relatives of missing persons. 42 U.S.C.A. § 14132(a).

102 For instance, travel to Cuba for reasons other than those relating to the commercial sale of agricultural commodities has been banned. 22 U.S.C.A. § 7209 (West 2001). In addition, passports may be restricted for travel or use in “a country with which the United States is at war, where armed hostilities are in progress, or where there is imminent danger to the public health or the physical safety of United States travelers.” 22 U.S.C.A. § 21 la. The constitutionality of these statutes has been upheld in cases such asZemel v. Rusk, in which the Supreme Court held that 22 U.S.C.A. § 21 la and similar statutes did not involve an improper delegation of legislative power or deny the plaintiff any of his constitutional rights. Zemel v. Rusk, 381 U.S. 1 (1965).

103 For example, the Raelains, a religious group that believes “that life on Earth was created by a race of human extraterrestrials using DNA engineering,” are going abroad to set up a cloning clinic in a country where cloning is not outlawed. Saltus, supra note 35. Also, if the battle over stem cell research continues, it is likely that doctors will leave the United States and go abroad in an attempt to perform the research and clinical trials they feel are necessary.

104 Gelehrter, supra note 16, at 314.

105 Id. at 314-19.

106 Id. at 319.

107 Id. at 320.

108 108Id. at 324.

109 Currently, pills that correct genetic diseases can be found on the market. Some of these pills act by releasing a protein that is either missing, produced at sub-optimal levels, or incorrectly made in the body. This extra protein corrects or improves the person's ailments. Other pills release a protein or chemical that blocks a protein cascade, thereby preventing a protein from acting where its action would have an undesired effect. Still other drugs work in multiple other ways. However, these pills are not GE drugs as the person's DNA is not changed.

110 Examples of illegal narcotics include drugs such as marijuana and cocaine that come from foreign countries and drugs such as methamphetamines or LSD that are manufactured in the United States.

111 Examples of prescription drugs that are currently regulated include drugs that either require a prescription in the United States, like Vicodin, morphine or Oxycontin, or prescription drugs, like Phen-fen, that were once lawfully sold in the United States and now are banned.

112 Liz Brody, Easy Drugs Online, Glamour, Apr. 2000, at 102. Examples of such web sites include: Diet Doc (last visited May 20, 2002)at http://dietdoc.org (offering “Our Secure Physician Consultations. . . [for] $75, which you add to your Xenical price”); International Online Pharmacy Club, at http://www.iopclub.com (last visited May 20, 2002) (promising that one will “learn the secrets of buying prescription drugs without a prescription on a 70% discount”); Worldpharmaices.Com, at http://worldpharmacies.com (last visited May 20, 2002) (advertising “sports enhancements” not available in the United States for $4 and up, “Fenfluramine” not available in the U.S. for $43 per 100 tablets, and “Smart Drugs” not available in the United States for $25).

113 Brody, supra note 112, at 102.

114 Id. at 104.

115 Id.

116 Id.

117 Id.

118 Jean Hellwege, Law Enforcement, Legislators Grapple with Child Sexual Exploitation on the Net, 36 Trial 13, 16(2000).

119 See generally M. Christina Ramirez, The Balance of Interests Between National Security Controls and First-Amendment Interests in Academic Freedom, 13 J.C. & U.L. 179 (1986).

120 31 U.S.C. § 5314(a) (1994).

121 id.§ 5316(a).

122 26 U.S.C. §7206(1) (1994).

123 See, e.g., United States v. Clines, 958 F.2d 578, 581-82 (1992). Cline was successfully prosecuted under 26 U.S.C. § 7206(1) and its corresponding regulation 31 C.F.R. § 103.24(a) for failing to check “yes” on his 1040 income tax form when asked whether or not he had a financial interest in a foreign financial account. He was also successfully prosecuted under 31 U.S.C. § 5314 and its corresponding regulation 31 C.F.R. § 103.26(d) for failing to file the required corresponding report.

124 One who willfully violates 31 U.S.C. § 5314 can have a civil money penalty imposed upon him or her of “the amount (not to exceed $100,000) of the transaction or $25,000.” 31 U.S.C.A. § 5321(a)(1). In addition, “A civil money penalty may be imposed . . . notwithstanding the fact that a criminal penalty is imposed with respect to the same violation.” Id. § 5321(d). 31 U.S.C. § 5323 also provides informants an award for information “which leads to a recovery of a criminal fine, civil penalty, or forfeiture, which exceeds $50,000, for a violation of this chapter.” The reward can be up to twenty-five percent of the net amount of the fine, penalty, or forfeiture collected or $15,000, whichever is less. Id. § 5321(d).

31 U.S.C.A. § 5322 outlines the criminal penalties. It states that a person who willfully violates a subchapter or regulation prescribed under a subchapter of this title “shall be fined not more than $250,000, or imprisoned for not more than five years, or both.” Id. § 5322(a). It also states that if one willfully violates this subchapter or regulation while “violating another law of the United States or as part of a pattern of any illegal activity involving more than $100,000 in a 12-month period, shall by fined not more than $500,000, imprisoned for not more than 10 years, or both.” Id. § 5322(b).

125 18 U.S.C.A. § 1956 (West 2001) states that it violates money laundering laws to knowingly conduct or attempt to conduct a financial transaction which involved the proceeds of specified unlawful activity. If the United States listed GE as such an activity, the fine for a GE crime could be up to “$500,000 or twice the value of the property involved in the transaction, whichever is greater, or imprisonment for not more than twenty years, or both.” 18 U.S.C.A. § 1956(2)(b)(ii).

In addition, the government could prosecute those engaging in GE for conspiracy to defraud the government under 18 U.S.C.A. § 371 if they conspire with others to launder money in pursuit of an illegal goal. See United States v. Inco Bank & Trust Corp, 845 F.2d 919 (11th Cir. 1988). “It is well settled that the government has the power to prosecute every member of a conspiracy that takes place in United States territory, even those conspirators who never entered the United States.” Id. at 920.

126 Examples include Somalia and Bosnia.

127 See Adam Smith, A High Price to Pay: The Costs of the U.S. Economic Sanctions Policy and the Need for Process Oriented Reform, 4 U.C.L.A. J. Int'l L. & Foreign Aff. 325, 330 (2000).

128 Smith describes economic sanctions as “coercive economic and commercial measures imposed by a country to condemn or influence the political behavior of one or more other countries.” Id. at 329. Economic sanctions include a reduction in foreign assistance, restrictions on trade with the United States, revocation of visas and other rights within the United States and seizure of assets. Id. See also John L. Ellicott, Export Controls: The Changing Scene, 752 PLI/Corp 261, 274-75 (1991) (outlining the types of prohibitions and activities that are included in embargoes).

The fight against illicit drugs provides another example of an economic sanction. Section 490(b)(1) delegates the power to “certify” major illicit drug producing and drug transit countries to the executive branch. If a country meets certain criteria, namely cooperating with the United States and taking steps within its borders to prevent the manufacture and trade of illicit drugs, then the executive branch can certify it. If the country does not meet the certification standards, the country faces possible economic sanctions such as having U.S. assistance withheld, or having the United States vote against multilateral development bank assistance. See Certification for Major Illicit Drug Producing and Drug Transit Countries, Pres. Determination no. 20001-12, 66 Fed. Reg. 14,454 (Mar. 1,2001), available at 2001 WL 236043.

129 50 U.S.C. § 1701 (1994). See also United States v. McKeeve, 131 F.3d 1, 10 (1st Cir. 1997) (“[The International Emergency Economic Powers Act] codifies Congress's intent to confer broad and flexible power upon the President to impose and enforce economic sanctions against nations that the President deems a threat to national security interests.”).

130 The power to declare a national emergency is specifically given in 50 U.S.C. § 1621.

131 Id. § 1702(a).

132 The President cannot regulate or prohibit “any postal, telegraphic, telephonic, or other personal communication, which does not involve a transfer of anything of value,” donations for humanitarian aid or anything that would endanger the Armed Forces. Id. § 1702(b).

133 “The President, in every possible instance, shall consult with the Congress before exercising any of the authorities granted by this chapter and shall consult regularly with the Congress so long as such authorities are exercised.” This requires periodic reports to Congress. Id. § 1703(a).

134 Smith, supra note 127, at 327

135 See, e.g., id.; see also Parker, Richard W., The Problem with Scorecards: How (And How Not) to Measure the Cost-Effectiveness of Economic Sanctions, 21 Mich. J. Int'l L. 235 (2000)Google Scholar.

136 The WTO is not a part of the United Nations, but it works closely with the United Nations through the International Trade Centre, which is a joint subsidiary of the WTO and the United Nations. The WTO was established January 1, 1995 to replace GATT and functions as the only international group that oversees international trade agreements. Basic Facts About the United Nations, supra note 43, at 50, 63-63. All decisions of the WTO are made by the member governments, which currently number 142, through a negotiated rulemaking process. See World Trade Org., The WTO, at http://www.wto.org/english/thewto_e/thewto_e.htm (last visited Mar. 17, 2002).

137 It is suspected that environmentalists will try to link “western environment standards to trade deals at the WTO meeting in Qatar this November.” If they succeed, development in poorer countries that cannot meet the standards will be harMed. Roger Bate, Europe's Eco-Imperialism, Wall St. J. Eur., Aug. 30, 2001, at 9, available at 2001 WL-WSJE 21836289.

138 “The WTO has no specific agreement dealing with the environment. However, a number of the WTO agreements include provisions dealing with environmental concerns. . . . The WTO is only competent to deal with trade. In other words, in environmental issues its only task is to study questions that arise when environmental policies have a significant impact on trade. The WTO is not an environmental agency. Its members do want it to intervene in national or international environmental policies or to set environmental standards.” World Trade Org., Beyond the Agreements: The Environment-A New High Profile, at http://www.wto.org/english/thewto_e/whatis_e/tif_e/bey4_e.htm (last visited Mar. 31, 2002).

139 World Trade Org., Early years: Emerging Environment Debate in GATT/WTO, at http://www.wto.org/english/tratop_e/envir_e/histl_e.htm (last visited Mar. 31, 2002).

140 On December 10, 1948 the United Nations adopted the Universal Declaration of Human Rights, which lists several basic rights that individuals in every country should enjoy. G.A. Res. 217A (III), U.N. Doc A/810, at 71 (1948). The Untied Nations has also adopted the Declaration on the Elimination of Violence Against Women, which includes similar rights. G.A. Res. 48/104, 48 U.N. GAOR Supp. No. 49, at 217, U.N. Doc. A/48/49 (1993).

141 The Declaration of the Rights of the Child was adopted by the General Assembly of the United Nations in 1959. C.H.R. Res. 1998/76, U.N. ESCOR Supp. No. 3, at 240, U.N. Doc. E/CN.4/1998/76 (1998).

142 The Universal Declaration on the Human Genome and Human Rights was passed in 1997 and is the first international text on the ethics of genetic research. Basic Facts About the United Nations, supra note 43, at 192.

143 The dictionary defines harmonization as “to bring or come into agreement.” Examples of international harmonization abound. See, e.g., United Nations Crime and Justice Information Network (UNCJIN), International Review of Criminal Policy: United Nations Manual on the Prevention and Control of Computer-Related Crime, http://www.uncjin.org/Documents/EighthCongress.html (last visited May 27, 2002); United Nations Economic Commission for Europe (UNECE) Working Party on Technical Harmonization and Standardization Policies, Programme of Work for 1999-2003, http://www.unece.org/trade/tips/stdpol/docs/progrm.pdf (last visited May 27, 2002) (this group is promoting development and trade in part by “encouraging the international harmonization of standards and technical regulations”); Organisation for Economic Co-operation and Development (OECD), Programme on the Harmonization of Regulatory Oversight in Biotechnology, http://wwwl.oecd.org/ehs/PROJECTS.HTM (last visited May 27, 2002) (promotes international harmonization in biotechnology).

144 Emst-Ulrich Petersmann, How To Reform The United Nations: Lessons From the International Economic Law Revolution, 2 UCLA J. Int'l L. & For. Aff. 185, 209-210 (1997).

145 For example, Article 7 of the Draft Additional Protocol to the Convention for the Protection of Human Rights and Dignity with Regard to the Application of Biology and Medicine on the Prohibition of Cloning Human Beings states:

1. Any Party may at any time denounce this Protocol by means of a notification addressed to the Secretary General of the Council of Europe.

2. Such denunciation shall become effective on the first day of the month following the expiration of a period of three months after the date of receipt of such notification by the Secretary general.

36 I.L.M. 1415, 1418 (1997). The Convention on Human Rights and Biomedicine contains nearly identical language in Article 37. 36 I.L.M. 817, 825 (1997).

146 David V. Eakin, The International Conference on Harmonization of Pharmaceutical Regulations: Progress or Stagnation?, 6 Tulsa J. Comp. & Int'l L. 221, 221 (1999).

147 Council of Europe, Recommendation 934 (1982) On Genetic Engineering, 4i, 4ii (Jan. 26, 1982), in Bioethics in Europe 302 (Arthur Rogers et al. eds., 1995).

148 Eugene B. Brody, Biomedical Technology and Human Rights 253 (1993).

149 U.S. Const, art. I, § 8, cl. 11. The War Powers Resolution clarifies the powers of the President and Congress:

50 U.S.C. § 1541(b)-(c) (1994).

150 Id.

151 151 Even following the terrorist attacks on September 11, 2001 Congress failed to officially declare war, authorizing the President to:

S.J. Res. 23 § 2, 107th Cong. (2002) (enacted). Of course one could argue that Congress chose this method of “declaring war” because at the time it was unknown exactly who to declare a war against. A similar statute could be used if GE ever became a great threat.

152 For a general discussion on the difficulties of international evidence gathering, see Ethan Avram Nadelmann, Cops Across Borders: the Internationalization of U.S. Criminal Law Enforcement 313-396 (1997).

153 “The requirement that the accused be confronted with the witnesses against him, and have compulsory process for obtaining witnesses in his favor, could render it difficult to conduct trials for crimes committed outside the United States unless the trial could be held in the place where the crime was committed.” Restatement (Third) of Foreign Relations Law of the United States § 422 reporter's n. 2 (1987). However, the United States has held criminal trials abroad, usually in “[c]onsular courts, pursuant to agreement with the foreign country.” Id. § 422 reporter's n. 4.

154 In Blackmer v. United States, a U.S. citizen who was a resident of Paris, France was subpoenaed to be a witness for the United States at two different trials. The United States prosecuted him for contempt for failure to appear and won. Defendant appealed to the Supreme Court asserting that the statute requiring him to appear and his prosecution were unconstitutional. Blackmer v. United States, 284 U.S. 421, 436 (1932). The Supreme Court held that the United States has jurisdiction over its absent citizens and U.S. law binds all citizens requiring them to appear before a court when requested. However, the Court noted that there must be due process and that due process requires “appropriate notice of the judicial action and an opportunity to be heard.” Id. at 438. The Court found that a subpoena was sufficient notice. Blackmer remains the law to this day. Restatement (Third) of Foreign Relations Law of the United States § 42l(2)(d). However, what if the government cannot get notice to someone in a foreign country? Also, what if the witness the United States wants to subpoena is not a U.S. citizen?

155 Letters rogatory are “written requests from a court in one state to a foreign court requesting the provision of evidence or some other form of assistance needed in a judicial proceeding. Law enforcement officials typically resort to letters rogatory when Interpol and other international police channels are unable to produce the requested evidence . . . Letters rogatory remain the principal means of obtaining evidence from abroad . . .” Nadelmann, supra note 152, at 318-19.

156 “The federal government pours about $20 billion a year into [the war on drugs], with state and local governments spending about the same amount.” Judy Mann, Money Spent on Drug War Could Be Put to Better Use, Wash. Post, Oct. 17, 2001, at C12. The DEA alone had a budget in 2001 of SI.66 billion. U.S. Dep't of Justice, Drug Enforcement Admin., DEA Budget - All Source, at http://www.usdoj.gov/dea/agency/staffingchartl.htm.

157 Altman, supra note 36; Brody, supra note 112, at 102; see also Jorge L. Cairo, Regulation of Intercountry Adoption: Can the Abuses Come to an End?, 18 Hastings Int'l & Comp. L. Rev. 121 (1994); Iris Leibowitz-Dori, Note, Womb for Rent: the Future of International Trade in Surrogacy, 6 Minn. J. Global Trade 329 (1997).

158 The U.S. Border Patrol, the “mobile uniformed law enforcement arm” of the Immigration and Naturalization Service, is solely responsible for “patrolling the 6,000 miles of Mexican and Canadian international land borders and the 2,000 miles of costal waters surrounding the Florida Peninsula and the island of Puerto Rico.” Immigration and Naturalization Serv., Border Patrol Overview, at http://www.ins.usdoj.gov/graphics/lawenfor/bpatrol/overview.htm (last visited Mar. 31, 2002).

159 See, e.g., sources citedsupra note 1.

160 See Washington Legal Found., v. Henney, 56 F. Supp. 2d 81 (D. D.C. 1999).

161 Universal Declaration on the Human Genome and Human Rights, supra note 19, art. 16.

162 “The right of people to be secure in their persons, houses, papers, and effects, against unreasonable searches and seizures, shall not be violated . . . .” U.S. Const, amend. IV.

163 Erwin Chemerinsky, Constitutional Law: Principles and Policies 695 (1997).

164 164 “Traditionally, we have abridged the individual's freedom of choice only in three situations: (1) when the individual is incompetent to choose, (2) when the choice will have a significant impact on the welfare of others, and (3) when leaving the choice up to the individual would be so inefficient that we delegate the decision to a better decision-maker. All three of these factors may affect our willingness to allow individuals to decide whether or not to obtain genetic enhancement.” See Mehlman, supra note 2, at 691.

165 The First Amendment limits what information the government can restrict, stating “Congress shall make no law . . . abridging the freedom of speech, or of the press . . . .” U.S. Const, amend. I.

166 For instance during the cold war, the Reagan Administration regarded scientific conferences and academic literature as “inherently adverse to U.S. military security interests.” Ramirez, supra note 119, at 180.

167 On October 26, 2001, President Bush signed the USA Patriot Act of 2001 in response to the terrorist attacks against the United States on September 11, 2001. This Act increases the money spent on antiterrorism measures, increases the scope of certain subpoenas, imposes additional trade sanctions, imposes additional hardships on those wishing to move money internationally, increases the penalties for money laundering, triples the number of Border Patrol personnel and customs agents, and expands the federal DNA database to include the DNA of anyone who commits a “crime of violence” or conspires to commit such crime. USA Patriot Act of 2001, Pub. L. No. 107-56, 115 Stat. 272 (2001).