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Journal of Biosecurity, Biosafety and Biodefense Law

Editor-in-Chief: Sutton, Victoria

Ed. by Sherwin, Brie

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2154-3186
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Mandatory Laboratory Regulations: Is the United States Over-Regulating Select Agent Research?

Brandon Schwarzentraub
Published Online: 2013-06-11 | DOI: https://doi.org/10.1515/jbbbl-2012-0009

About the article

Published Online: 2013-06-11


David R. Franz et al., Medical Aspects of Chemical and Biological Warfare, 431(1997), available at http://ww.phsource.us/PH/CBRNE/MABCW/Ch19.pdf

See Henry A. Kissinger, National Security Decision Memorandum 35 (Nov. 25, 1969); National Security Decision Memorandum 44 (Feb. 20, 1970).

Franz, supra note 1.

Joel Bouze et al., A Yersinia pestis YscN ATPase mutant functions as a live attenuated vaccine against bubonic plague in mice 332(2) FEMS Microbiology Letters (2012) 113, available at http://onlinelibrary.wiley.com/doi/10.1111/j.1574-6968.2012.02583.x/pdf

Xiangguo Qui et al., Ebola GP-Specific Monoclonal Antibodies Protect Mice and Guinea Pigs from Lethal Ebola Virus Infection 6(3) PLOS Neglected Tropical Diseases (2012), http://www.plosntds.org/article/info%3Adoi%2F10.1371%2Fjournal.pntd.0001575

Rebecca Katz, Biological Weapons: A National Security Problem that Requires a Public Health, Off. of Population Res. Princeton Un., available at http://opr.princeton.edu/papers/opr0104.pdf

See Biological Weapons Anti-Terrorism Act, 18 U.S.C. § 175 (2006).

See 42 C.F.R. § 73 et seq.

See Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review, 76 Fed. Reg. 61206–01 (Oct. 3, 2011).

Optimizing the Security of Biological Select Agents and Toxins in the United States, Exec. Order No. 13546, 75 Fed. Reg. 39439, 39439 (July 2, 2010).

Id.

See Victoria Sutton, Survey Finds Biodefense Researchers Anxiety – Over Inadvertently Violating Regulations, 7 Biosecurity & Bioterrorism: Biodefense Strategy, Practice, and Science 225, 225 (2009).

See id.

Victoria Sutton, The Culture of Science and the Regulation and Litigation of Biodefense Research, 6:3 Univ. St. Thomas L. J. 523, 526 (2010).

Id.

Biological Weapons Anti-Terrorism Act, 18 U.S.C. § 175 (2006).

Sutton, supra note 14, at 526.

Id. at 524.

Id. at 523–24.

Sutton, supra note 12, at 225.

Id.

See Peter Emanuel, Presidential Order Balances Security and Scientific Enterprise, available at http://www.whitehouse.gov/blog/2010/07/02/presidential-order-balances-security-and-scientific-enterprise.

Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction, 26 U.S.T. 583, 1015 U.N.T.S. 163 (Apr. 10, 1972).

Biological Weapons Anti-Terrorism Act, 18 U.S.C. § 175 (2006).

Id.

Id.

Sutton, supra note 14, at 526.

Antiterrorism and Effective Death Penalty Act of 1996, 18 U.S.C. § 175 (2002).

Id.

Id.

See 42 C.F.R. § 73 et seq (2008).

Additional Requirements for Facilities Transferring or Receiving Select Agents, 61 Fed. Reg. 55,190, 55,194 (Oct. 24, 1996).

18 U.S.C. § 175 (2002).

§ 175(a).

§ 175(b).

Id.

Public Health and Bioterrorism Preparedness Act of 2002, 42 U.S.C. § 262a.

42 C.F.R. § 73 (2005).

Id.

42 C.F.R. §§ 73.17, 73.73.11, 73.7, 73.10 (2008).

42 C.F.R. § 73.2 (2005).

7 C.F.R. § 331.2 (2005).

9 C.F.R. § 121.2 (2005).

42 C.F.R. § 73.2 (2005).

See Victoria Sutton, Law and Biotechnology, 31 (Carolina Academic Press ed. 2007).

42 U.S.C. § 262a(a)(1)(A) (2002).

§ 262a(a)(1)(B)(i).

See 42 C.F.R. § 73 et. seq.

Sutton, supra note 14, at 535–36.

Id. at 536–37.

Id. at 539–40.

42 C.F.R. § 73.3(e) (2008).

§ 73.3(e)(1).

§ 73.3(e)(3).

Possession, Use, and Transfer of Select Agents and Toxins, 70 Fed. Reg. 13294, 13296 (Mar. 18, 2005).

Id.

Id.

Id.

Id.

See 42 C.F.R. § 73.5(a) (2008).

Id.

§ 73.5(a), (b).

42 C.F.R. § 73.3(d)(1) (2008).

Id.

See Possession Use, and Transfer of Select Agents and Toxins, 70 Fed. Reg. at 13,299.

See id.

42 C.F.R. § 73.12(c) (2005).

§ 73.12(a)

Additional Requirements for Facilities Transferring or Receiving Select Agents, 61 Fed. Reg. at 55,191.

Id.

Id.

Sutton, supra note 14, at 540.

See 42 C.F.R. § 73.13 (2005).

§ 73.13(b)(1).

§ 73.13(a).

Possession, Use, and Transfer of Select Agents and Toxins, 70 Fed. Reg. at 13,308–09.

Id. at 13,307.

42 C.F.R. § 73.10(a) (2005).

42 C.F.R. § 73.10(g) (2005).

42 C.F.R. § 73.10(f) (2005).

18 U.S.C. § 175b (2012).

Possession, Use, and Transfer of Select Agents and Toxins, 70 Fed. Reg. at 13,305.

Id.

See 42 C.F.R. § 73.17(a)(1) (2005).

Id.

See Possession, Use, and Transfer of Select Agents and Toxins, 76 Fed. Reg. 61206, 61213 (Oct. 3, 2011).

See Possession, Use, and Transfer of Select Agents and Toxins, 70 Fed. Reg. at 13,311.

Sutton, supra note 12, at 225.

Exec. Order No. 13546, 75 Fed. Reg. 39439 (2010).

Id.

Id.

Id.

Id.

Id.

Id.

Id. (The panel consists of representatives from the following agencies: the Department of State, the Department of Defense, the Department of Justice, the Department of Agriculture, the Department of Commerce, the Department of Health and Human Services, the Department of Transportation, the Department of Labor, the Department of Energy, the Department of Veterans Affairs, the Department of Homeland Security, the Environmental Protection Agency, the Office of the Director of National Intelligence, the Office of Science and Technology Policy, the Joint Chiefs of Staff, and any other department or agency designated by the Department of Agriculture or the Department of Health and Human Services).

Id. at 39441.

See Possession, Use, and Transfer of Select Agents and Toxins: Biennial Review, 76 Fed. Reg. 61206 (Oct. 3, 2011).

See id.

Id. at 61208.

It should be noted that the Texas Tech Center for Biodefense, Law, and Public policy sent the CDC a Freedom of Information Act (FOIA) request concerning the criteria that lead to the decision to include a particular select agent or toxin in the current select agent list. That request was sent in 2008 and an appeal of the denial was sent in 2009. In the years that followed, regular correspondence was sent to the CDC requesting the dissemination of criteria for the selection of select agents; however, the CDC never responded. Over half of the October 3, 2011, Notice of Proposed Rulemaking lays out rather detailed criteria considered by the CDC in deciding whether to add, remove, retain, or tier a particular select agent or toxin.

Possession, Use, and Transfer of Select Agents and Toxins: Biennial Review, 76 Fed. Reg. 61206, 61208 (Oct. 3, 2011).

Id.

Id. at 61208–12.

Id.

Id. at 61213.

Id. at 61212.

Possession, Use, and Transfer of Select Agents and Toxins: Biennial Review 76 Fed. Reg. 61206.

Id.

Id.

Id. at 61222.

42 C.F.R. § 73.3(c)(1)-(2) (2008); 42 C.F.R. § 73.4(c)(1)-(2) (2008).

§§ 73.3(c)(2), 73.4(c)(2).

See Possession, Use, and Transfer of Select Agents and Toxins: Biennial Review, 76 Fed. Reg. 61206, 61213 (Oct. 3, 2011).

Id. at 61215–16.

Id. at 61216.

Id. at 61215.

42 C.F.R. § 73.11(b) (2005).

Possession, Use, and Transfer of Select Agents and Toxins: Biennial Review, 76 Fed. Reg. at 61206, 61215 (Oct. 3, 2011).

42 C.F.R. § 73.1 (2005).

Possession, Use, and Transfer of Select Agents and Toxins: Biennial Review, 76 Fed. Reg. at 61,224.

See id.

See Possession, Use, and Transfer of Select Agents and Toxins: Biennial Review, 76 Fed. Reg. 61206, 61213 (Oct. 3, 2011).

Id. at 61215.

Id.; Plants and animals exposed to select toxins are exempted from this requirement as possibility of actually isolating a usable amount of the toxin from the plant or animal is not feasible.

42 C.F.R. § 73.11(c)(1) (2005).

See Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review, 76 Fed. Reg. at 61,224.

Id.

Id.

Id.

Victoria Sutton, Smarter Regulations Commentary on “Responsible Conduct by Life Scientists in an Age of Terrorism,” 15 Sci. Eng. Ethics 303, 308 (2009).

Possession, Use, and Transfer of Select Agents and Toxins: Biennial Review, 76 Fed. Reg. at 61,222.

Id.

Id. at 61,221.

Possession, Use, and Transfer of Select Agents and Toxins, 70 Fed. Reg. at 13,305.


Citation Information: Journal of Biosecurity, Biosafety, and Biodefense Law, ISSN (Online) 2154-3186, ISSN (Print) 2194-590X, DOI: https://doi.org/10.1515/jbbbl-2012-0009.

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