TSCA and engineered nanoscale substances

Nanotechnology Law and Business

Volumn 4, Issue 1, 2007, Pages 51-74

  Bergeson, Lynn L ^a,b,c   Plamondon, Joseph E ^a  

^a BERGESON AND CAMPBELL P C   (United States)

^b AMERICAN CHEMISTRY COUNCIL   (United States)

^c AMERICAN BAR ASSOCIATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ENVIRONMENTAL PROTECTION; LAWS AND LEGISLATION; RISK ASSESSMENT; TOXIC MATERIALS;

CHEMICAL SUBSTANCES; POTENTIAL RISKS; TOXIC SUBSTANCES CONTROL ACT (TSCA);

NANOSTRUCTURED MATERIALS;

EID: 34848852645     PISSN: 15462080     EISSN: 15462080     Source Type: Journal    
DOI: None     Document Type: Article

References (128)

1. Other articles on this subject include: Lynn Bergeson & Bethami Auerbach, Reading the Small Print, 21 ENV'T FORUM 30 (2004);
2. Linda K. Breggin, Securing the Promise of Nanotechnology: Is the U.S. Environmental Law up to the Job? A Dialogue, ENVTL. LAW. INST. (Woodrow Wilson Int'l Ctr. for Scholars Project on Emerging Nanotech.), Oct. 2005, available at http://www.elistore.org/reports detail.asp?ID=11116.;
3. Peter J. Tomasco, Manufactured Nanomaterials: Avoiding TSCA and OSHA Violations for Potentially Hazardous Substances, 33 B.C. ENVTL. AFF. L. REV. 205 (2006);
4. Ahson Wardak, Nanotechnology & Regulation: A Case Study Using the Toxic Substance [sic] Control Act (TSCA), INT'L ASS'N OF NANOTECH. (Woodrow Wilson Int'l Ctr. for Scholars), 2003, available at http://www.ianano.org/Nanotech-Regulation.pdf.
5. National Nanotechnology Initiative, What is Nanotechnology?, http://www.nano.gov/html/facts/whatIsNano.html (last visited Feb. 7, 2007).
6. M.C. Roco, Government Nanotechnology Funding: An International Outlook, NAT'L SCI. FOUND., June 30, 2003, http://www.nano.gov/html/res/IntlFundingRoco.htm (last visited Feb. 7, 2007).
7. Günter Oberdörster, Eva Oberdörster & Jan Oberdörster, Nanotechnology: An Emerging Discipline Evolving from Studies of Ultrafine Particles, 113 ENVTL. HEALTH PERSPECTIVES, 823 (2005).
8. See also Jennifer Sass, Patrice Simms & Elliott Negin, Nanotechnologies: The Promise and the Peril, 6 SUSTAINABLE DEV. L. & POL'Y 11 (2006) (single-walled carbon nanotubes (SWCNTS) have been reported by five different research groups to be associated with lung toxicity). The authors recognize that there is considerable debate over the definitions of nanoparticle and particulate nanomaterial. We make no attempt to define these terms more than we have in the article, and use the terms interchangeably throughout the article.
9. Torsten Hansen et al., Biological tolerance of different materials in bulk and nanoparticulate form in a rat model: sarcoma development by nanoparticles. 3 J. ROYAL SOC. INTERFACE 767 (2006) (toxicity of certain nanoparticles in vitro found cytotoxic effects in some nanoparticles), available at http://www.journals. royalsoc.ac.uk/media/p81htpxwwrjmgc6uhqrl/contributions/r/2/0/g/ r20g806u0881u1r4.pdf (free registration required).
10. See Nat'l Sci. & Tech. Council. The National Nanotechnology Initiative Research and Development Leading to a Revolution in Technology and Industry, (Supplement to the President's 2007 Budget), NAT'S NANOTECH. INITIATIVE, July 2006, available at http://www.nano.gov/NNI_07Budget.pdf.
11. Most notably, the U.K. Department of Environment, Food & Rural Affairs (DEFRA) launched a Voluntary Reporting Scheme for Engineered Nanoscale Materials in September 2006, which will run until September 2008. See DEFRA, Voluntary Reporting Scheme for engineered nanoscale materials, Nov. 2006, http://www.defra.gov.uk/environment/nanotech/policy/index.htm.
12. See Nanoscale Materials; Notice of Public Meeting, 70 Fed. Reg. 24,574 (May 10, 2005).
13. NAT'L POLLUTION PREVENTION & TOXICS ADVISORY COMM., EPA, OVERVIEW DOCUMENT ON NANOSCALE MATERIALS (NOV. 22, 2005), http://www.epa.gov/opptintr/ npptac/pubs/nanowgoverviewdocument20051125.pdf.
14. See Lynn 1. Bergeson, Nanotechnology and TSCA, 6 ABA PESTICIDE, CHEM. REG. & RIGHT-TO- KNOW COMM. NEWSLETTER 11 (ABA Section for Env't, Energy, & Res.), Apr. 2005, at 11, http://www.abanet.org/environ/ committees/pesticides/newsletter/apr05/pesticides0405.pdf.
15. Science Policy Council: Nanotechnology Workgroup, Nanotechnology White Paper, EPA, 1 (Feb. 15, 2007), available at http://www.epa.gov/osa (EPA White Paper).
16. Notice of Expert Peer Review Meeting on the Nanotechnology White Paper External Review Draft. 71 Fed. Reg. 14, 205 (Mar. 21, 2006).
17. Certain New Chemicals; Receipt and Status Information, 71 Fed. Reg. 46,475, 46,480 (Aug. 14, 2006); see also Pat Phibbs-Rizzuto, EPA Reviews 15 New Nanoscale Chemicals, But Finds Only One With Unique Properties, 158 BNA DAILY ENV'T REP., Aug. 16, 2006, at A-7.
18. Certain New Chemicals; Receipt and Status Information, 70 Fed. Reg. 46,513, 46,517 (Aug. 10, 2005).
19. Toxic Substances Control Act, 15 U.S.C. §§ 2601-2692 (2006).
20. See Toxic Substances Control Act § 2(b), 15 U.S.C. § 2601(b)(2) (2006).
21. Toxic Substances Control Act § 3(2)(A), 15 U.S.C. § 2602(2)(A) (2007);
22. See also 40 C.F.R. §§ 710.3(d), 720.3(e) (2007). TSCA Section 3(2)(B) excludes from the definition of "chemical substance" mixtures, pesticides, tobacco and tobacco products, certain nuclear materials, firearms and ammunition, and foods, food additives, drugs, cosmetics, and devices. 15 U.S.C. § 2602(2)(B) (2007);
23. see also 40 C.F.R. §§ 710.3(d), 720.3(e) (2007). All of these categories, with the exception of mixtures, are regulated under other federal laws. TSCA defines a "mixture" as "any combination of two or more chemical substances if the combination does not occur in nature and is not, in whole or in part, the result of a chemical reaction." Also included within the definition is any chemical substance that is the result of a chemical reaction, but that could have been manufactured for commercial purposes without a reaction. Toxic Substances Control Act § 3(8), 15 U.S.C. § 2602(8) (2007);
24. see also 40 C.F.R. §§ 710.3(d), 720.3(u) (2007). In addition to these statutory exclusions, EPA's regulations exclude "articles" and other types of substances (e.g., certain impurities and byproducts) for purposes of various TSCA provisions.
25. See, e.g., 40 C.F.R. §§ 704.5, 710.4(d), 720.30 (2007).
26. Toxic Substances Control Act § 8(b)(1), 15 U.S.C. § 2607(B)(b)(1) (2006).
27. See Availability of TSCA Initial Inventory; Beginning of 210-Day Reporting Period for Revised Inventory, 44 Fed. Reg. 28,558 (May 15, 1979). The Inventory is continually updated by adding "new chemical substances" for which a premanufacture notice (PMN) and subsequent notice of commencement (NOC) have been submitted pursuant to TSCA Section 5. As of early 2007, there were approximately 83,000 chemical substances listed on the TSCA Inventory - roughly 66,400 non-confidential chemical substances and roughly 16,600 confidential chemical substances. The TSCA Inventory has two components: (1) a Public Inventory, which includes all existing chemical substances whose identity has not been claimed as confidential business information (CBI); and (2) a Confidential Inventory, which is accessible only by EPA and includes all existing chemical substances whose identity has been claimed as CBI.
28. See 40 C.F.R. § 720.25(b)(1) (2007). Chemical substances on the TSCA Public Inventory are listed by a specific chemical name and a Chemical Abstracts Service (CAS) Registry Number - a unique number assigned by the CAS to a specific chemical substance - while chemical substances whose identities are claimed confidential are listed in the TSCA Public Inventory by an EPA-assigned accession number and a generic chemical name. Id.
29. Toxic Substances Control Act § 3(9), 15 U.S.C. § 2602(9) (2007);
30. see also 40 C.F.R. §§ 710.3, 720.3(v), 720.25(a) (2007).
31. See generally Toxic Substances Control Act § 2(a)(2), 15 U.S.C. § 2601(a)(1-2) (2006) (congressional finding that "there are [chemical substances and mixtures] whose manufacture, processing, distribution in commerce, use, or disposal may present an unreasonable risk of injury to health or the environment").
32. Toxic Substances Control Act § 3(7), 15 U.S.C. § 2602(7) (2007). Under the implementing regulations for TSCA Sections 5 and 8, "manufacture" is defined to mean "to manufacture, produce, or import for commercial purposes," which in turn is defined to mean "to manufacture, produce, or import with the purpose of obtaining an immediate or eventual commercial advantage." See, e.g., 40 C.F.R. § 710.3(d) (2007).
33. Toxic Substances Control Act § 5(a), 15 U.S.C. § 2604(a) (2006).
34. The PMN regulations are at 40 C.F.R. pt. 720 (2007), and PMN exemptions are at 40 C.F.R. pt. 723 (2007). Existing chemical substances already listed on the TSCA Inventory may be subject to a Significant New Use Rule (SNUR), which also is authorized under TSCA Section 5 and 40 C.F.R. pt. 721, subpt. E and is discussed below.
35. See Toxic Substances Chemical Substances Inventory extract database search, CORNELL UNIV. DEPT. OF ENV'T HEALTH & SAFETY, http://msds.ehs.comell.edu/tscasrch.asp (last visited Feb. 5, 2007) (unofficial version).
36. See 40 C.F.R. § 720.25(a)(5) (2007).
37. See id. at pt. 720, subpt. C (2007);
38. EPA, EPA Form 7710-25, available at http://www.epa.gov/opptintr/ newchems/pubs/pmnforms.htm.
39. See 40 C.F.R. §§ 720.40(d), 720.50 (2007). The phrase "known to or reasonably ascertainable by" is defined at 40 C.F.R. § 720.3(p) (2007).
40. Toxic Substances Control Act § 5(a), (c), 15 U.S.C. § 2604(a), (c) (2006); 40 C.F.R. § 720.75. The review period can be extended repeatedly.
41. See Toxic Substances Control Act § 5(h)(3), 15 U.S.C. § 2604(h)(3) (2006);
42. see also 40 C.F.R. § 720.36 (2007).
43. 40 C.F.R. § 720.3(cc) (2007).
44. Id.; see also EPA, New Chemical Information Bulletin: Exemptions for Research and Development and Test Marketing, at 5 (Nov. 1986), http://www.epa.gov/opptintr/newchems/pubs/tmeranddbulletin.pdf.
45. 40 C.F.R. § 720.3(ee) (2007). This regulation defines a TQI as a person: (1) who, because of education, training, or experience, or a combination of these factors, is capable of understanding the health and environmental risks associated with the chemical substance which is used under his or her supervision, (2) who is responsible for enforcing appropriate methods of conducting scientific experimentation, analysis, or chemical research to minimize such risks, and (3) who is responsible for the safety assessments and clearances related to the procurement, storage, use, and disposal of the chemical substance as may be appropriate or required within the scope of conducting a research and development activity.
46. Id. § 723.50(a)(2), (g) (2007). This review period can be suspended to allow EPA a longer review period.
47. As noted, EPA approved the first LoREX for what is believed to be a single wall carbon nanotube in October 2005. The review and approval period was 13 months. See e.g., supra note 13.
48. See 40 C.F.R. § 723.50(a), (c) (2007). One kilogram is equivalent to 2.2 pounds.
49. Id. § 723.50(c)(2).
50. Id. § 723.50(d).
51. Id. § 723.50(g)(2). TSCA Section 5(e) grants EPA the authority to issue administrative orders controlling new chemical substances where it finds that there is insufficient information for reasonable evaluation of the risk and either the chemical may present an unreasonable risk to health or the environment (referred to as a "risk-based" finding), or will be produced in substantial quantities that will enter the environment or to which there will be substantial or significant human exposure (referred to as an "exposure-based" finding). Toxic Substances Control Act § 5(e)(1)(C), 15 U.S.C. § 2604(e)(1)(A) (2006). Additionally, EPA may ban or limit the manufacture, processing, distribution, use, or disposal of the chemical. EPA must propose Section 5(e) orders prior to the expiration of the 90-day PMN review period, and a proposed order will become effective upon the expiration of that period unless the manufacturer that submitted the PMN files objections to the order. Toxic Substances Control Act § 5(e)(1)(C), 15 U.S.C. § 2604(e)(1)(C) (2006). As a matter of practice, however, rather than acting unilaterally under Section 5(e), EPA typically enters into a consent order with the manufacturer, under which the manufacturer agrees to restrict the manufacture, processing, distribution, use, or disposal of the new chemical substance as provided in the order. Consent orders permit the manufacturer to distribute the chemical substances, subject to various restrictions, pending the development of data necessary to evaluate potential hazards.
52. The American Bar Association (ABA) Section of Environment, Energy, and Resources (SEER) completed and released publicly a comprehensive legal review of TSCA and nanotechnology in June 2006. ABA SEER, Regulation of Nanoscale Materials under the Toxic Substances Control Act, (June 2006), (ABA SEER Paper), available at http://www.abanet.org/environ/nanotech/pdf/TSCA.pdf. The ABA SEER paper notes that TSCA Section 5 gives EPA authority to assess the risks of individual chemical substances and to impose limitations on their manufacture, processing, distribution, and use in appropriate cases, including prohibiting their manufacture altogether. Specifically, "[t]his TSCA section has twin provisions: Section 5(a)(1) for "new" chemical substances, and Section 5(a)(2) for significant new uses of existing chemical substances. While the two provisions have different triggers, once triggered they operate almost identically. Much discussion and papers from various stakeholders have focused on EPA's ability to use Section 5(a)(1) to regulate as "new" chemical substances nanomaterials for which conventional-sized versions are already on the TSCA Chemical Substances Inventory (Inventory). Assuming that such distinctions reasonably can be drawn in individual cases, the arguments for this use of Section 5(a)(1) face obstacles. In contrast, the Section 5(a)(2) SNUR process appears to offer EPA adequate authority to effectively regulate nanoscale versions of materials that are already on the TSCA Inventory." Id. at 5.
53. S. REP. NO. 94-698, at 19 (1976), as reprinted in 1976 U.S.C.C.A.N. 4491 (Legislative History of the Toxic Substances Control Act). For example, EPA may issue orders under Sections 5(e) and 5(f) with respect to chemicals notified under either Section 5(a)(1) or Section 5(a)(2), as both provisions refer to "a chemical substance with respect to which notice is required by subsection (a)."
54. See 40 C.F.R. § 720.22 (2007).
55. Procedurally, a SNUR rulemaking is conducted under the provisions of the Administrative Procedure Act, under which the public is offered an opportunity to provide comment. 5 U.S.C. § 553 (2007). The process involves publication of a proposed rule in the Federal Register, and publication of a final rule after EPA has reviewed and considered public comment. EPA has issued more than 700 SNURs using this procedure, and is quite experienced in these matters. Thus, SNURs are by far the most common subject of rulemaking under TSCA. See generally id.
56. See Toxic Substances Control Act § 19(c)(1)(B), 15 U.S.C. § 2618(c)(1)(B) (2006).
57. Toxic Substances Control Act § 26(c)(2)(A), 15 U.S.C. § 2625(c)(2)(A) (2006).
58. Significant New Uses of Certain Acrylate Esters, 58 Fed. Reg. 61,649 (Nov. 22, 1993) (to be codified at 40 C.F.R. pt. 721).
59. Certain Acrylate Esters; Withdrawal of Proposed Significant New Use Rule, 62 Fed. Reg. 1,305 (Jan. 9, 1997) (to be codified at 40 C.F.R. pt. 721).
60. See Charles Auer, Kenneth Moss & James Alwood, Acrylate regulation under TSCA, 4 CHEM. HEALTH SAFETY, 38 (1997) (EPA authors details the history of the SAM Panel and Generic Acrylate SNUR).
61. See, e.g., 40 C.F.R. § 721.9582 (2007) (covering 88 perfluoroalkyl sulfonates); Perfluoroalkyl Sulfonates; Proposed Significant New Use Rule, 71 Fed. Reg. 12,311 (Mar. 10, 2006) (to be codified at 40 C.F.R. pt. 721) (proposed addition of 183 perfluoroalkyl sulfonates). EPA's regulatory action is one in a series involving the voluntary phase-out of perfluoroalkyl sulfonate (PFAS) substances, which began in 2000 when the sole U.S. manufacturer of perfluroroctanyl sulfonate (PFOS) voluntarily withdrew production from the market. EPA thereafter issued a SNUR applicable to 13 PFAS substances. Perfluoroalkyl Sulfonates; Proposed Significant New Use Rule, 67 Fed. Reg. 11,014 (Mar. 11, 2002) (to be codified 40 C.F.R. pt. 721). In December 2002, EPA issued a second SNUR applicable to 75 PFAS substances. Perfluoroalkyl Sulfonates; Significant New Use Rule, 67 Fed. Reg. 72,854 (Dec. 9, 2002) (to be codified at 40 C.F.R. pt. 721). EPA's regulation of these chemicals through the use of SNURs has been identified by some TSCA experts as a success story. See Oversight Hearing on Implementation of TSCA Before the Comm. on Env't & Public Works, 152 Cong. (2006)
62. (written testimony of William K. Rawson, Partner & Chair of the Env't, Land & Res. Dept. in Wash. D.C.) available at http://epw.senate.gov/109th/Rawson_Testimony.pdf.
63. Toxic Substances Control Act § 6(a), 15 U.S.C. § 2605(a) (2006).
64. Toxic Substances Control Act § 6(a)(1)-(7). 15 U.S.C. § 2605(a)(1)-(7) (2006).
65. Toxic Substances Control Act § 6(a), 15 U.S.C. § 2605(a) (2006).
66. See e.g., Corrosion Proof Fittings v. EPA, 947 F.2d 1201 (5th Cir. 1991) (rules that EPA neglected, among other things, to consider the least burdensome approach to addressing risk before it banned most uses of asbestos still in commerce, thus requiring the Court to invalidate this component of the rule).
67. Because CFCs were banned under the Clean Air Act Amendments of 1990, EPA revoked its TSCA regulations for CFCs in 1995. See Chemical Substances; Deletion of Certain Chemical Regulations; Technical Amendments to the Code of Federal Regulations, 60 Fed. Reg. 31917 (June 19, 1995) (to be codified at 40 C.F.R. pts. 61, 704, 710, 712, 762, 763, 766, 790, 795, 796, 797, 798, & 799).
68. See 40 C.F.R. pt. 747 (2007).
69. Asbestos; Friable Asbestos-Containing Materials in Schools; Identification and Notification, 47 Fed. Reg. 23360 (May 27, 1982) (to be codified at 40 C.F.R. pt. 763). When Congress, in 1986, enacted Subchapter II of TSCA to address asbestos hazards, EPA revoked the TSCA regulations and promulgated regulations implementing the new statute.
70. 40 C.F.R. pt. 749, subpt. D (2007).
71. Toxic Substances Control Act § 7(a), 15 U.S.C. § 2606(a) (2007).
72. 40 C.F.R. § 717.3(a) (2007).
73. Id. at § 717.17(a)-(b).
74. Toxic Substances Control Act § 8(e), 15 U.S.C. § 2607(e) (2007).
75. TSCA Section 8(e); Notification of Substantial Risk; Policy Clarification and Reporting Guidance, 68 Fed. Reg. 33129, 33138 (June 3, 2003) (guidance document articulating EPA's preferences for how and where TSCA section 8(e) notices should be submitted).
76. Id.
77. Id. at 33137; see also Toxic Substance Control Act, Notification [sic] of Substantial Risk Under Section 8(e), 43 Fed. Reg. 11110, 11111 (Mar. 16, 1978) (states EPA's interpretation of, and enforcement policy concerning, section 8(e) of the TSCA).
78. EPA, TSCA Section 8(e) Reporting Guide at 6 (June 1991) available at http://www.epa.gov/oppt/tsca8e/pubs/rguide.htm.
79. See EPA, EPA Settles PFOA Case Against DuPont for Largest Environmental Administrative Penalty in Agency History, (Dec. 14, 2005), available at http://yosemite.epa.gov/opa/admpress.nsf/ d9bf8d9315e942578525701c005e573c/fdcb2f665cac66bb852570d7005d6 665!OpenDocument;
80. Joseph E. Plamondon, The DuPont TSCA Enforcement Action: Implications for the Chemical Industry, 15 ENV'T QUALITY MGMT. 1 (2006).
81. See Natural Resources Defense Council et al., EPA Proposal to Regulate Nanomaterials Through a Voluntary Pilot Program, EPA, at 11-12 (July 5, 2005), EPA Docket OPPT-2004-0122, Doc. ID EPA-HQ-OPPT-2004-0122-0037 at http://www.regulations.gov;
82. see Letter from Richard A. Denison, Ph.D., Senior Scientist & Karen Florini, Senior Attorney, Environmental Defense to The Honorable Susan B. Hazen, Acting Assistant Administrator, EPA at 3 (Sept. 2, 2004) (on file with Env't Defense Fund at http://www.environmentaldefense.org/documents/ 4457_NanotechLetterToEPA.pdf).
83. The Royal Society and the Royal Academy of Engineering 2004, Nanoscience and Nanotechnologies: Opportunities and Uncertainties, THE ROYAL SOCIETY (July 29, 2004), available at http://www.nanotec.org.uk/finalReport.htm.
84. See also Karen Florini et al., Nanotechnology: Getting It Right the First Time, 6 SUSTAINABLE DEV. L. & POL'Y 46, 51 (2006) (ED has urged the EPA to clarify that nanomaterials with existing molecular structures still constitute "new" substances unless their chemical and physical properties are demonstrably identical to those of the conventional substance. This definition is based on the grounds that only substances with the same properties, as well as the same molecular structure, share a "particular molecular identity.")
85. Letter from Richard A. Denison & Karen Florini A. Klee at 1 (May 22, 2006) (ED Letter) (on file with author).
86. See id.
87. Id. at 3.
88. Id. at 3-4.
89. Id. at 4.
90. Premanufacture Notification; Revisions of Premanufacture Notification Regulations; Final Rule, 60 Fed. Reg. 16298, 16299 (Mar. 29, 1995) (to be codified at 40 C.F.R. pts. 704, 720 & 721).
91. ED Letter at 5.
92. Id. at 6.
93. Toxic Substances Control Act § 3(2)(A), 15 U.S.C. § 2602(2)(A) (2007); See also 40 C.F.R. §§ 710.3(d), 720.3(e) (2007). Subparagraph (B) expressly excludes the following from the definition of "chemical substance": mixtures; pesticides; tobacco and tobacco products; certain nuclear materials; firearms and ammunition; and food, food additives, drugs, cosmetics, and devices. Toxic Substances Control Act § 3(2)(B), 15 U.S.C. § 2602(2)(B) (2007);
94. See also 40 C.F.R. §§ 710.3(d), 720.3(e) (2007). With the exception of mixtures, all of these categories are regulated under other federal laws. The introductory language in Section 3(2)(A) emanates from the TSCA legislation first proposed by EPA in February 1971, "The Toxic Substances Control Act of 1971," which would have amended the Federal Hazardous Substances Act. That proposed legislation, in turn, grew out of a Council on Environmental Quality (CEQ) report on perceived "problems associated with toxic substances in the environment" that found that existing legal authorities were "inadequate to control the actual and potential dangers of toxic substances comprehensively or systematically."
95. In a House Foreign and Interstate Commerce Committee Report on the EPA-proposed TSCA legislation that passed the full House in 1972, and which defined "chemical substance" in a virtually identical manner to TSCA Section 3(2), the Committee observed that "[t]he definition [of 'chemical substance'] is specifically limited to substances of a particular molecular identity, and in using the word 'element' the committee means the customary definition of a chemical element." H.R. REP. NO. 92-1477, at 5 (1972). The reported legislation, S. 1478, defined "chemical substance" to mean "any organic or inorganic substance of a particular molecular identity, or any uncombined chemical radical or element."
96. See 40 C.F.R. §§ 710.3, 720.3(v), 720.25(a) (2007).
97. See TSCA Inventory Nomenclature for Enzymes and Proteins, 69 Fed. Reg. 65565, 65567 (Nov. 15, 2004) (to be codified at 40 C.F.R. pt. 720) (stating "[t]he only way to determine if a substance is new or existing is by consulting the TSCA Inventory");
98. Fed. Reg. 64572, 64591 (Dec. 23, 1977) (to be codified at 40 C.F.R. pt. 710) (promulgation of the original Inventory reporting regulations, stating that the Inventory "defines what is a 'new chemical substance' for purposes of [the PMN requirements in] section 5(a)(1)(A).");
99. See also Becky Cool, EPA's New Chemical Program Under Section 5 of TSCA, presentation before WOODROW WILSON INT'L CTR. FOR SCHOLARS (Oct. 2, 2003) (available at Env't Futures at http://www.environmentalfutures.org/nanotech_2.pdf) (under most circumstances, an "'existing' chemical substance is one that was reported for EPA's initial TSCA Inventory as being already in U.S. commerce"; a "'new' chemical substance is one that does not appear on EPA's TSCA Inventory").
100. ABA SEER Paper at 8, citing Chemistry Assistance Manual for Premanufacture Notification Submitters (EPA 744-R-97-003) at 15-16 (Mar. 1997), available at http://www.epa.gov/opptintr/newchems/pubs/chem-pmn/ index.htm.
101. Toxic Substances Control Act § 3(2)(A)(i), 15 U.S.C. § 2602(2)(A)(i) (2007).
102. ABA SEER Paper at 9.
103. Id. at 9-10.
104. Id. at 10-11.
105. Letter from Henry P. Lau, Chief, Chemical Inventory Section, EPA, to Daniel C Hakes, 3M (Nov. 19, 1993) (IC-4482) (on file with author).
106. These Inventory entries were accepted mainly or exclusively during the original development of the Inventory, when EPA added tens of thousands of substances at once and circumstances precluded as thorough a consideration of particular entries as the PMN review process does today.
107. An administrative law judge rejected EPA's motion for summary judgment in a TSCA enforcement matter where EPA asserted that sub-molecular differences between an existing chemical substance and the chemical subject to the enforcement action allowed EPA to treat the latter as "new." In The Matter Of Concord Trading Corp., Docket No. TSCA-94-H-19 (July 24, 1997).
108. See Wikipidia the Free Encyclopedia, Allotropy, http://en.wikipedia.org/wiki/Allotropy (last visited Feb. 8, 2007).
109. See Wikipedia the Free Encyclopedia, Allotropes of carbon, http://en.wikipedia.org/wiki/Allotropes_of_carbon (last visited Feb. 8, 2007).
110. As noted above, EPA's treatment of the relevance of chemical structure would suggest that EPA could well take into account a chemical's physical structure and conclude that different physical forms or structures of a chemical whose chemical composition is identical are nonetheless "new" for TSCA purposes.
111. See 40 C.F.R. § 721.25(a) (2007), (SNUN); Id. at § 720.40(a)(2) (PMN).
112. EPA, EPA Authorities Under TSCA 1 at 12 (July 11, 2005) (EPA TSCA Authorities) available at http://www.chemicalspolicy.org/downloads/ TSCAAuthorities050615.pdf.
113. Toxic Substances Control Act § 5(e)(1)(A), 15 U.S.C. § 2604(e)(1)(A) (2007);
114. Toxic Substances Control Act § 5(f)(1), (3)(A)(i), 15 U.S.C. § 2604(f)(1), (3)(A)(i) (2007).
115. Toxic Substances Control Act § 5(a)(2)(B)-(D), 15 U.S.C. § 2604(a)(2)(B)-(D) (2007).
116. Perfluoroalkyl Sulfonates; Proposed Significant New Use Rule, 71 Fed. Reg. 12311, 12314 (Mar. 10, 2006) (to be codified at 40 C.F.R. pt. 721).
117. EPA TSCA Authorities at 14.
118. Toxic Substances Control Act § 26(c)(2)(A), 15 U.S.C. § 2625(c)(2)(A) (2007).
119. Id.
120. EPA, TSCA New Chemicals Program (NCP) Chemical Categories at 118-121, (Oct. 2002), available at http://www.epa.gov/opptintr/newchems/ pubs/cat02.pdf.
121. See supra note 67, Karen Florini et al., Nanotechnology: Getting It Right the First Time.
122. ED Letter at 3-4, supra note 68;
123. Ahson Wardak, Nanotechnology & Regulation: A Case Study Using the Toxic Substance [sic] Control Act (TSCA) at 11, supra note 2.
124. Pat Phibbs, Manufacture of New Carbon Nanotube Approved by EPA Under an Exemption, BNA DAILY ENV'T REP., Oct. 21, 2005, at A-1.
125. See Jim Alwood, EPA. Presentation to AM. CHEMISTRY COUNCIL/SOCMA GLOBAL CHEM. REGULATIONS CONF. (Mar. 22, 2005) (TSCA Section 8(e) reporting applies to nanoscale material).
126. Toxic Substances Control Act § 8(e), 15 U.S.C. § 2607(e) (2007).
127. To date, EPA has received at least one Section 8(e) submission addressing an engineered nanoscale material, although it is not clear from the submission whether the nanoscale material was "existing" or "new." See 8EHQ-0403-15319 (Apr. 10, 2003) http://www.epa.gov/oppt/tsca8e/pubs/ 8ehq/2003/april03/8ehq-0403-15319a.pdf (last visited Dec. 1, 2006). The submission, made by DuPont, reported a lung toxicity rat study on single-walled carbon nanotubes.
128. See 40 C.F.R. § 717.3(e)(1) (2007).