Information generation and use under proposition 65: Model provisions for other postmarket laws?

Indiana Law Journal

Volumn 83, Issue 2, 2008, Pages 609-627

  Cranor, Carl ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 47049087593     PISSN: 00196665     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (95)

1. CAL. HEALTH & SAFETY CODE §§ 25249.5-13 (2007).
2. 7 U.S.C. § 136 (2000).
3. 21 U.S.C. §§ 301-399. (2000).
4. 15 U.S.C. §§ 2601-2692 (2000).
5. Carl F. Cranor, Some Legal Implications of the Precautionary Principle: Improving Information Generation and Legal Protections, in 2 EUROPEAN JOURNAL OF ONCOLOGY LIBRARY 31-51(2003).
6. For example, there might be features of substances that would indicate that some would require greater testing and scrutiny and some less. Thus, there might be a "tiered" review system, with greater or lesser degrees of scrutiny.
7. NAT'L RESEARCH COUNCIL, TOXICITY TESTING: STRATEGIES TO DETERMINE NEEDS AND PRIORITIES 12, 84 (1984).
8. See CARL F. CRANOR, TOXIC TORTS: SCIENCE, LAW AND THE POSSIBILITY OF JUSTICE 337-91 (2006).
9. CAL. HEALTH & SAFETY CODE § 25249.6 (2007).
10. Id. § 25249.5 (2007).
11. CAL. CODE REGS. tit. 22, § 12102 (2007).
12. CAL. HEALTH & SAFETY CODE § 25249.8(b) (2007);
13. CAL. CODE REGS. tit. 22, §§ 12301-12305 (2007).
14. CAL. HEALTH & SAFETY CODE § 25249.8(a) (2007).
15. This was a precursor committee to the Carcinogen Identification Committee.
16. CAL. HEALTH & SAFETY CODE § 25249.8(a);
17. CAL. CODE REGS. tit. 22, § 12306 (1)-(m) (2007);
18. W. Crop Prot. Ass'n v. Davis, 95 Cal. Rptr. 2d 631 (Cal. Ct. App. 2000).
19. CAL. CODE REGS. tit. 22, § 12306 (1)-(m).
20. CAL. HEALTH & SAFETY CODE § 25249.8(b);
21. CAL. CODE REGS. tit. 22, §§ 12301-12305.
22. Edward Weil, Deputy Attorney Gen., State of Cal., Lecture at the University of California, Berkeley (Feb. 2, 2005) (citing CAL. HEALTH & SAFETY CODE § 25249.8(a);
23. CAL. CODEREGS. tit. 22, § 12902) (lecture notes on file with the Indiana Law Journal).
24. CAL. HEALTH & SAFETY CODE § 25249.10(c) (2007).
25. Interview with Lauren Zeise, Chief of Reprod. & Cancer Hazard Assessment, Office of Envtl. Health Hazard Assessment, Cal. Envtl. Prot. Agency (Feb. 2000) (summarizing Proposition 65 options open to a firm that exposes the public to a listed toxicant).
26. CAL. CODE REGS. tit. 22, § 2601 (a) (2007). "Whenever a clear and reasonable warning is required under Section 25249.6 of the Act, the method employed to transmit the warning must be reasonably calculated, considering the alternative methods available under the circumstances, to make the warning message available to the individual prior to exposure. The message must clearly communicate that the chemical in question is known to the state to cause cancer, or birth defects or other reproductive harm."
27. Id.
28. CAL.CODE REGS. tit. 22, § 12601(c)(1)(A)-(C) (2007).
29. CAL. HEALTH & SAFETY CODE § 25249.10(c).
30. CAL. CODE REGS. tit. 22, § 12703(b) (2007).
31. CAL. HEALTH & SAFETY CODE § 25249.10(c).
32. Baxter Healthcare Corp. v. Denton, 15 Cal. Rptr. 3d 430, 453 (Cal. Ct. App. 2004).
33. Consumer Cause, Inc. v. SmileCare, 110 Cal. Rptr. 2d 627, 635 (Cal. Ct. App. 2001).
34. CAL. HEALTH & SAFETY CODE § 25249.10(a).
35. CAL. HEALTH & SAFETY CODE § 25249.7(b) (2007).
36. Council for Educ. and Research on Toxics v. McDonald's Corp., No. BC280980 (L. A. Super. Ct. Mar. 23, 2005).
37. Int'l Agency for Research on Cancer, IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Volume 60: Some Industrial Chemicals, available at http://monographs.iarc.fr/ENG/Monographs/vol60/volume60.pdf.
38. CAL. HEALTH & SAFETY CODE § 25249.12(b) (2007).
39. Edward Weil, Deputy Attorney Gen., State of Cal., Presentation to the Northern California Society for Risk Analysis (2005) (lecture notes on file with the Indiana Law Journal).
40. Id.
41. Zeise, supra note 20.
42. CAL. LAB. CODE § 6382(c) (2007).
43. These numbers were supplied to the author by a Cal EPA employee. Communication from Sara Hoover, Research Scientist, Office of Envtl. Health Hazard Assessment, Cal. Envtl. Prot. Agency, to author (Sept. 9, 2006) (on file with the Indiana Law Journal). Because of Proposition 65's provisions, this list is continually updated and is something of a moving target; a frequently updated link to the latest list of substances is available at http://www.oehha.ca.gov/prop65/prop65_list/Newlist.html.
44. The author was a member of the Carcinogen Assessment Committee. The original data analysis was conducted during 1991-92. See Carl F. Cranor, The Social Benefits of Expedited Risk Assessments, 15 RISK ANALYSIS 353, 354 (1995).
45. CAL. CODE REGS. tit. 22, § 12703(b) (2007).
46. See REPROD. & CANCER HAZARD ASSESSMENT BRANCH, OFFICE OF ENVTL. HEALTH HAZARD ASSESSMENT, CAL. ENVTL. PROT. AGENCY, PROPOSITION 65 SAFE HARBOR LEVELS: NO SIGNIFICANT RISK LEVELS FOR CARCINOGENS AND MAXIMUM ALLOWABLE DOSE LEVELS FOR CHEMICALS CAUSING REPRODUCTIVE TOXICITY (2005), available at http://www.oehha.ca.gov/prop65/pdf/Aug2005StatusReport.pdf.
47. CAL. CODEREGS. tit. 22, § 12703(b) (2007).
48. A "person-year" is calculated by multiplying the number of people working on a potency assessment by the number of years they work.
49. A "person-day" is calculated by multiplying the number of people working on a potency assessment by the number of days they work.
50. NAT'L RESEARCH COUNCIL, RISK ASSESSMENT IN THE FEDERAL GOVERNMENT: MANAGING THE PROCESS 28 (3d prtg. 1984).
51. See id.
52. See supra text accompanying notes 20-27.
53. In the late 1990s an additional eight expedited potency assessments were issued, when there were data available (a particular database of animal studies), and the state had resources to issue the potency assessments. Interview with Sara Hoover, Sara Hoover, Research Scientist, Office of Envtl. Health Hazard Assessment, Cal. Envtl. Prot. Agency (Sept. 9, 2006).
54. Interview Interview with Lauren Zeise, Chief of Reprod. & Cancer Hazard Assessment, Office of Envtl. Health Hazard Assessment, Cal. Envtl. Prot. Agency (June 2000).
55. That is, on a natural log scale they are within +1 or -1 of being completely accurate. A natural log value of+1 translates into a multiplicative number no greater than 7.4.
56. See Sara M. Hoover, Lauren Zeise, William S. Pease, Louise E. Lee, Mark P. Henning, Laura B. Weiss & Carl Cranor, Improving the Regulation of Carcinogens by Expediting Cancer Potency Estimation, 15 RISK ANALYSIS 267, 272, 277 tbl.4, 278 tbl.5 (1995). Identical substances that were independently assessed for their potency by means of science-intensive and time-consuming procedures by the two different agencies differed in the potency calculations by a greater amount than the expedited and science-intensive potency assessments completed by California EPA.
57. See id. These comparisons provide a measure of the accuracy of the expedited potency assessments.
58. See Cranor, supra note 38, at 355-57.
59. For more details of this model, see id.
60. This is a database of animal studies on carcinogenic substances created by Lois Gold and her associates at the University of California, Berkeley, from which the potency assessments may be calculated. See Lois Swirsky Gold, Charles B. Sawyer, Renae Magaw, Georganne M. Backman, Margarita de Veciana, Robert Levinson, N. Kim Hooper, William R. Havender, Leslie Bernstein, Richard Peto, Malcolm C. Pike & Bruce N. Ames, A Carcinogenic Potency Database of the Standardized Results of Animal Bioassays, 58 ENVTL. HEALTH PERSP. 9, 22-305 (1984).
61. See generally Cranor, supra note 38;
62. Hoover et al., supra note 50.
63. 42 U.S.C. §§ 6901-6992 (2000).
64. 42 U.S.C. §§ 9601-9675 (2000).
65. SeeU.S.OFFICEE OF TECH. ASSESSMENT, U.S. CONGRESS, IDENTIFYING AND REGULATING CARCINOGENS 134-35 (1987), available at http://www. theblackvault.com/documents/ota/Ota_3/DATA/1987/8711.PDF.
66. Id. at 136.
67. CAL. HEALTH & SAFETY CODE § 25249.10(c) (2007).
68. See Consumer Cause, Inc. v. SmileCare, 110 Cal. Rptr. 2d 627,633-36 (Cal. Ct. App. 2001).
69. See supra notes 20-27 and accompanying text.
70. CAL. HEALTH & SAFETY CODE § 25249.7(b)(1) (2007).
71. International Scientific Committee, International Conference on Fetal Programming and Development, The Faroes Statement: Human Health Effects of Developmental Exposure to Chemicals in Our Environment, May 24, 2007, 102 BASIC & CLINICAL PHARMACOLOGY & TOXICOLOGY 73, 73-75 (2008), available at http://www.pptox.dk/ Consensus/tabid/72/Default.aspx
72. [hereinafter Faroes Statement].
73. Carl F. Cranor, The Legal Failure to Prevent Subclinical Toxicity, 102 BASIC & CLINICAL PHARMACOLOGY & TOXICOLOGY 267, 267-72 (2008).
74. See Faroes Statement, supra note 63.
75. See U.S. Environmental Protection Agency, Endocrine Disrupter Screening Program Background, http://www.epa.gov/endo/pubs/edspoverview/ background.htm.
76. Cranor, supra note 64, at 270.
77. . 42 U.S.C. §§ 11001-05, 11021-23, 11041-50 (2000).
78. Id. § 11023;
79. see generally U.S. Environmental Protection Agency, Toxics Release Inventory Program, http://www.epa.gov/tri/.
80. This should not be underestimated as a form of regulation by social pressure, but it lacks the full effectiveness of Proposition 65.
81. 42 U.S.C. §§ 4331-4370 (2000).
82. 7 U.S.C. § 136 (2000);
83. U.S.C. §§ 1531-1544 (2000).
84. A species is endangered when it is "in danger of extinction throughout all or a significant portion of its range." 16 U.S.C § 1532 (2000). It is "threatened" when it "is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range." Id. Both are "scientific call[s] on how close the species is to the brink."
85. WILLIAM H. RODGERS, ENVIRONMENTAL LAW 1004 (2d ed. 1994).
86. Oliver A. Houck, The Endangered Species Act and Its Implementation by the U.S. Departments of Interior and Commerce, 64 U. COLO. L. REV. 277, 285 (1993).
87. RODGERS, supra note 73, at 1004 (quoting 16 U.S.C. § 1533(b)(1)(A) (1994)).
88. City of Las Vegas v. Lujan, 891 F.2d 927, 933 (D.C. Cir. 1989).
89. 33 U.S.C. § 1344 (2000).
90. See id.
91. See Memorandum of Agreement Between the Department of the Army and the Environmental Protection Agency: The Determination of Mitigation Under the Clean Water Act Section 404(b)(1) Guidelines, http://www.epa.gov/OWOW/wetlands/ regs/mitigate.html [hereinafter Guidelines]. Proposed activities are regulated through a permit review process. An individual permit is required for potentially significant impacts.
92. See id. Individual permits are reviewed by the U.S. Army Corps of Engineers, which evaluates applications under a public interest review, as well as the environmental criteria set forth in the Guidelines.
93. See id.
94. RODGERS, supra note 73, at 339.
95. Cranor, supra note 5, at 49.