Examples of recent epa regulation of nanoscale materials under the Toxic Substances Control Act

Nanotechnology Law and Business

Volumn 6, Issue 3, 2009, Pages 388-406

  Monica Jr , John C ^a   Monica, Johne C ^a  

^a LLC ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACUTE TOXICITY; DATA COLLECTION; EPA REGULATIONS; NANO-SCALE MATERIALS; SIGNIFICANT NEW USE RULES; TOXIC SUBSTANCES CONTROL ACTS; U.S. ENVIRONMENTAL PROTECTION AGENCY;

CARBON NANOTUBES; ENVIRONMENTAL PROTECTION AGENCY; LAWS AND LEGISLATION; MATERIALS TESTING; NANOSTRUCTURED MATERIALS;

TOXIC MATERIALS;

EID: 70350438825     PISSN: 15462080     EISSN: 15462080     Source Type: Journal    
DOI: None     Document Type: Article

References (115)

1. Toxic Substances Control Act of 1976, 53 U. S. C. §§ 2601-92.
2. EPA Notice, 73 Fed. Reg. 64946 (Oct. 31, 2008).
3. 53 U. S. C. § 2604 (e).
4. See generally http://www.epa.gov/opptintr/newchems/pubs/cnosnurs.htm (describing EPA Consent Orders).
5. Office of Pollution Prevention and Toxics, Environmental Protection Agency, Regulation of a New Chemical Substance Pending Development of Information, re: Premanufacture Notice No. P-08-0177, Consent Order and Determinations Supporting Consent Order, available at http://www.nanolawreport. com/EPA%20Premanufacture%20Notice%20Number%20P-08-0177.pdf (providing a copy of the first consent order for a multi-walled carbon nanotube).
6. See also Press Release, Thomas Swan Gains Second Carbon Nanotube EPA Approval, http://www.thomasswan. co.uk/ASP/NewsEvents/NewsEvents.asp?Type= News&ID=187&Arc=&DLT=Thomas%20Swan%20Gains %20Second%20Carbon%20Nanotube%20EPA%20Approval (last visited July 15, 2009).
7. 53 U. S. C. § 2604 (a) (2).
8. See generally http://www.epa.gov/opptintr/newchems/pubs/cnosnurs.htm (describing EPA Significant New Use Rules).
9. EPA Notice, 73 Fed. Reg. 65751-52 (Nov. 5, 2008), PMN Number P-05-673 and PMN Number P-05-687.
10. Significant New Use Rules on Certain Chemical Substances, 40 C. F. R. §§ 721.10154-55 (2009).
11. Certain substances regulated under other statutes are generally excluded from TSCA, including, among others, food, drugs, cosmetics and pesticides. Summary of the Toxic Substances Control Act, http://www.epa.gov/lawsregs/laws/ tsca.html (last visited Nov., 2008). TSCA also provides exceptions/exemptions for chemical substances produced in low volumes or for research and development purposes, 53 U. S. C. § 2604 (h) (3).
12. Under the applicable statute, relevant factors in this consideration are: (i) the projected volume of manufacturing and processing of a chemical substance, (ii) the extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance, (iii) the extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance, and (iv) the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance, 15 U. S. C. § 2604 (a) (2).
13. TSCA Inventory Status of Nanoscale Substances - General Approach Jan. 23, 2008, http://www.epa.gov/oppt/nano/nmsp-inventorypaper2008.pdf.
14. Id.
15. Id.
16. Id.
17. EPA Notice, 73 Fed. Reg. 64946 (Oct. 31, 2008).
18. Id.
19. Id.
20. Id.
21. Consent Orders and Significant New Use Rules (SNURS), http://www.epa.gov/opptintr/newchems/pubs/cnosnurs.htm (last visited Nov., 2008).
22. TSCA 5 (e) Exposure-Based Policy: Criteria, http://www.epa.gov/oppt/ newchems/pubs/expbased.htm (last visited Nov., 2008).
23. Consent Orders, supra note 19;
24. see also Making a Finding on Unreasonableness of Risk, http://www.epa.gov/opptintr/newchems/pubs/unrerisk.htm (last visited Nov., 2008) ("The term "unreasonable risk" is not defined in the ⋯ TSCA. The legislative history, however, indicates that unreasonable risk involves the balancing of the probability that harm will occur and the magnitude and severity of that harm against the effect of a proposed regulatory action on the availability to society of the expected benefits of the chemical substance. In the context of the New Chemicals Program, EPA considers unreasonableness of risk both in the context of individual chemical substances and in considering whether to exempt categories of chemical substances.").
25. Consent Orders, supra note 19.
26. Id.
27. Id.
28. EPA, Consent Order and Determinations Supporting Consent Order, (redacted version) available at http://www.nanolawreport.com/ EPA%20Premanufacture%20Notice%20Number%20P-08-0177.pdf.
29. Id. at Section IV.
30. Id. at Section V.
31. Id. at Section IV.
32. Id.
33. Id. at Section V
34. 40 CFR 721.10119.
35. See also EPA Notice, 73 Fed. Reg. 65751, 65763 (referencing PMN Number P-05-673).
36. 40 CFR 721.10120.
37. See also EPA Notice, 73 Fed. Reg. 65752, 65763 (referencing PMN Number P-05-687).
38. Numbers P-05-673 & 687, respectively.
39. 73 Fed. Reg. 65751-52.
40. Id.
41. Significant New Use Rules on Certain Chemical Substances, supra note 8.
42. Environmental Protection Agency, Consent Orders and Significant New Use Rules (SNURs), http://www.epa.gov/oppt/newchems/pubs/cnosnurs.htm (last visited July 15, 2009).
43. See EPA Issues Clarification Regarding Carbon Nanotube SNURs, available at http://www.nanolawreport.com/2009/07/articles/carbon-nanotubes/epa-issues- clarification-regardingcarbon-nanotube-snurs/.
44. 74 Fed. Reg. 42177-78.
45. See 40 C. F. R. 721.160 (a) (2).
46. 74 Fed. Reg. 38880.
47. Id.
48. EPA, Consent Order and Determinations Supporting Consent Order, (redacted version) available at http://www.nanolawreport.com/ EPA%20Premanufacture%20Notice%20Number%20P-08-0177.pdf, at Section VI. Swan is given the opportunity to use an alternative test designated as OECD 413.
49. In May 2008, EPA also provided notice through the federal Regulatory Information service that it may issue a TSCA Section 4 (a) test rule to gather data, "to determine the health effects of multi-walled carbon nanotubes." http://www.reginfo.gov/pub/do/eAgendaViewRule?pubID= 200904&RIN=2070-AJ47 (last visited July 15, 2009). The notice indicates that the potential test rule is a substantive, non-significant, long-term action.
50. 73 Fed. Reg. 65751-52 (referencing PMN Numbers P-05-673 and P-05-687).
51. supra note 36.
52. OPPTS 870.3465 or OECD 413. Consent Order, Section II (d) (1).
53. Medline defines "chronic" as follows: "marked by long duration, by frequent recurrence over a long time, and often by slowly progressing seriousness ⋯ having a slow progressive course of indefinite duration-used especially of degenerative invasive diseases, some infections, psychoses, and inflammations ⋯, " http://www2.merriam- webster.com/cgibin/mwmednlm?book=Medical&va=chronic.
54. Summary, OECD Guidelines, available at http://www.oecd.org/dataoecd/37/ 24/40277898.doc.
55. Section 1 (b), Purpose, OPPTS Guidelines, available at http://www.epa.gov/opptsfrs/publications/OPPTS-Harmonized/870-Health-Effects- Test-Guidelines/Series/87 0-3465.pdf.
56. The Study will use specified mice as its subjects.
57. OPPTS Guidelines, supra note 50.
58. Id.
59. "Recommended testing, " EPA Notice, 73 Fed. Reg. 65751-52 (Nov. 5, 2008).
60. The precautionary principle implies a willingness to take action in advance of scientific proof on the grounds that further delay will prove injurious to society. The February 2, 2000 European Commission Communication on the Precautionary Principle states that the principle applies where scientific evidence is insufficient, inconclusive or uncertain and preliminary scientific evaluation indicates that there are reasonable grounds for concern that the potentially dangerous effects on the environment, human, animal or plant health may be inconsistent with the high level of protection chosen by the EU, available at http://eurlex.europa.eu/LexUriServ/LexUriServ. do?uri=COM:2000: 0001:FIN:EN:PDF.
61. 40 C. F. R. 721.10155-56 (referencing Swan's MWCNT and SWCNT under PMN P-08-177 and PMN P-08-328, respectively
62. see also 74 Fed. Reg. 29982-98, especially 29991, 29998 (June 24, 2009)).
63. 15 U. S. C. § 2614
64. see also http://epw.senate.gov/tsca.pdf (Senate version of TSCA, as amended through Dec. 32, 2002).
65. 40 C. F. R. § 720.120 (b).
66. 40 C. F. R. § 720.120 (c).
67. 40 C. F. R. § 720.120 (d).
68. 40 C. F. R. § 720.120 (e).
69. 40 C. F. R. § 720.120 (f).
70. Id.
71. 15 U. S. C. § 2615 (a) (1).
72. Id.
73. 15 U. S. C. § 2615 (a) (2) (B).
74. 15 U. S. C. § 2615 (b).
75. 15 U. S. C. § 2616 (a) - (b).
76. Id.
77. 15 U. S. C. § 2610.
78. 15 U. S. C. § 2617.
79. "Person" includes the United States and any other governmental instrumentality or agency. 15 U. S. C. § 2619 (a).
80. Id.
81. 15 U. S. C. § 2620.
82. Id.
83. 15 U. S. C. § 2619 (c) (2).
84. EPA, Consent Order and Determinations Supporting Consent Order, (redacted version) available at http://www.nanolawreport.com/ EPA%20Premanufacture%20Notice%20Number%20P-08-0177.pdf, at Section II (d) (1).
85. Consent Order, Preamble, at Section VI.
86. Id.
87. Id.
88. The United Kingdom's Natural Environment Research Council (NERC), together with its Engineering & Physical Sciences Research Council, U. K.'s Department for Environment, Food & Rural Affairs and its Environment Agency, in cooperation with the United States Environmental Protection Agency and the National Science Foundation, are in the process of finalizing a major joint research effort to "develop and validate predictive tools and similar conceptual models that predict exposure, bioavailability and effects of manufactured nanomaterials in the environment." The intent of this effort is to form a "consortia" of U. K. and U. S. investigators using combined but independent national funding from each country. http://www.nerc.ac.uk/research/programmes/nanoscience/events/jointresearch.asp (last visited Dec., 2008).
89. Consent Order, Preamble, at Section VI.
90. The EPA test protocol is quite detailed in how the study must be conducted and written up after it is completed, setting out a very costly regime. A good example is how the mice that are used to conduct the study must be cared for: "Animal Husbandry - Animals should be individually identified, preferably with subcutaneous transponders, to facilitate observations and avoid confusion. The temperature of the experimental animal maintenance room should be 22±3°C. The relative humidity should ideally be maintained in the range of 30 to 70%, though this may not be possible when using water as a vehicle. Before and after exposures, animals may be caged in groups by sex and concentration, but the number of animals per cage should not interfere with clear observation of each animal and should minimize losses due to cannibalism and fighting. When animals are to be exposed nose-only, it may be necessary for them to be acclimated to the restraining tubes. While animals are being exposed whole-body to an aerosol, they should be housed individually to prevent ingestion of test article due to grooming of cage mates. Conventional laboratory diets may be used, except during exposure, accompanied with an unlimited supply of municipal drinking water. Lighting should be artificial, the sequence being 12 hours light/12 hours dark." OECD 413 Guideline, Section 8, available at http://www.oecd.org/dataoecd/37/24/40277898. doc.
91. One can only imagine what it would be like for a single company or even a group of potential nanotechnology users to join the "consortia" study being proposed by the UK's Natural Environment Research Council in cooperation with the U. S. Environmental Protection Agency and National Science Foundation.
92. See note 81, supra. Effective control over this study will surely rest with the sponsoring UK and US agencies and organizations.
93. The Antitrust Division of the United States Department of Justice is charged with enforcing the U. S. antitrust laws. http://www.usdoj.gov/atr/ overview.html (last visited July, 2009).
94. U. S. Department of Justice, "Antitrust Enforcement and the Consumer, " (2007) http://www.usdoj.gov/atr/public/div-stats/211491.htm.
95. Most states have antitrust laws that are based upon and comparable to the federal antitrust laws. However, the various states may have added language or entire provisions to their antitrust statutes. Thus, the antitrust statutes of a particular state must be reviewed when determining the applicable law of that state.
96. 15 U. S. C. § 1.
97. Id.
98. The discussion in this section is taken from a publication disseminated on line by the FTC entitled, "A Guide To The Federal Trade Commission, " available at http://www.ftc.gov/bcp/edu/pubs/consumer/general/gen03.shtm (last visited Aug., 2009).
99. 15 U. S. C. § 15.
100. 15 U. S. C. §§ 4301-06.
101. As amended by the Standards Development Organization Advancement Act of 2004, Pub. L. No. 108-237, 118 Stat. 661 (2004).
102. Pub. L. 103-42, June 10, 1993.
103. 15 U. S. C. § 4301.
104. 15 U. S. C. § 4302.
105. In construing and applying the Sherman Act's ban against contracts, combinations and conspiracies in restraint of trade, the "rule of reason" is usually applied whereby the trier of fact (court or jury) reviews the particular actions that constitute the alleged restraint of trade to determine whether they are unreasonable. In considering the "reasonableness" of the actions the trier of fact can consider the business justifications for the conduct and its impact on competition. However, the Supreme Court has held that certain agreements or practices are so "plainly anticompetitive, " National Society of Professional Engineers v. United States, 435 U. S. 679, 692 (1978);
106. Continental T. V., Inc. v. GTE Sylvania, Inc., 433 U. S. 36, 50 (1977)
107. and so often "lack any redeeming virtue, " Northern Pac. R. Co. v. United States, 356 U. S. 1, 5 (1958), that they are conclusively presumed illegal without further examination. Thus, these practices are "per se" illegal under the antitrust laws. Price fixing is one of these practices. It has long been settled that an agreement to fix prices is unlawful per se and will not be tolerated. It is no excuse that the prices fixed are themselves reasonable.
108. See, e.g., United States v. Trenton Potteries Co., 273 U. S. 392, 397-398 (1927). Joint boycotts are also deemed per se illegal.
109. 15 U. S. C. § 4304.
110. Id.
111. A substantially prevailing claimant is entitled to recover the cost of suit, including a reasonable attorney's fee. 15 U. S. C. § 4304.
112. C. Poland, et al., Carbon Nanotubes Introduced Into The Abdominal Cavity Of Mice Show Asbestos-Like Pathology In A Pilot Study, 3 Nature Nanotechnology 423, (2008);
113. and A. Kane, et al., The Asbestos Analogy Revisited, 3 Nature Nanotechnology 78-79 (2008).
114. But see Monica & Monica, A Nano-Mesothelioma False Alarm, 5 Nanotechnology Law & Business 319 (2008).
115. 15 U. S. C. § 1.