1932
0
  1. Home
  2. A-Z Publications
  3. Annual Review of Public Health
  4. Volume 36, 2015
  5. Article

Annual Review of Public Health

Volume 36, 2015

Regulating Chemicals: Law, Science, and the Unbearable Burdens of Regulation

Abstract

The challenges of regulating industrial chemicals remain unresolved in the United States. The Toxic Substances Control Act (TSCA) of 1976 was the first legislation to extend coverage to the regulation of industrial chemicals, both existing and newly registered. However, decisions related to both law and science that were made in passing this law inevitably rendered it ineffectual. Attempts to fix these shortcomings have not been successful. In light of the European Union's passage of innovative principles and requirements for chemical regulation, it is no longer possible to deny the opportunity and need for reform in US law and practice.

Keyword(s): burden of proof, REACH, Toxic Substances Control Act, toxicology, TTIP
Loading

Article metrics loading...

/content/journals/10.1146/annurev-publhealth-031914-122654
2015-03-18
2024-06-14
Loading full text...

Full text loading...

/deliver/fulltext/publhealth/36/1/annurev-publhealth-031914-122654.html?itemId=/content/journals/10.1146/annurev-publhealth-031914-122654&mimeType=html&fmt=ahah

Literature Cited

  1. Aidala JV Jr, Auer CM, Goldman LR, Gulliford JB. 1.  2010. Practical Advice for TSCA Reform: An Insider Perspective Chicago: Am. Bar Assoc., Sect. Environ., Energy, Resour., Spec Comm. TSCA Reform. http://epw.senate.gov/public/index.cfm?FuseAction=Files.View&FileStore_id=86806f67-e47e-4cf3-9612-550104e7685a [Google Scholar]
  2. Applegate JS. 2.  2008. Synthesizing TSCA and REACH: practical principles for chemical regulation reform. Ecol. Law Q. 35:4721–69 [Google Scholar]
  3. Arrow K, Bolin B, Costanza R, Dasgupta P, Folke C. 3.  et al. 1995. Economic growth, carrying capacity, and the environment. Science 268:5210520–21 [Google Scholar]
  4. Birnbaum LS. 4.  2010. TSCA reform under way in Congress. Environ. Health Perspect. 118:A106 [Google Scholar]
  5. 5. CDC (Cent. Dis. Control Prev.) 2014. Human biomonitoring program Updated Aug. 18. CDC, Atlanta. http://www.cdc.gov/biomonitoring/ [Google Scholar]
  6. 6. CEFIC 2014. The European Chemical Industry: Facts and Figures 2013 Brussels: CEFIC http://asp.zone-secure.net/v2/598/765/42548/Cefic-Facts-and-Figures-.pdf [Google Scholar]
  7. 7. CEFIC 2014. Landscape of the European Chemical Industry March 2014 Brussels: CEFIRC http://www.cefic.org/Documents/Landscape-European-chemical-industry/Landscape-of-the-European-Chemical-Industry-March-2014.pdf [Google Scholar]
  8. 8. CEQ (US Counc. Environ. Qual.) 1971. Toxic Substances Washington, DC: Gov. Print. Off. [Google Scholar]
  9. 9. Chem. Alliance 2014. EPA's new chemicals program under TSCA: the basics Updated Nov. 14. Chem. Alliance, Washington, DC. http://www.chemalliance.org/topics/?subsec=27&id=689 [Google Scholar]
  10. 10. Chem. Insp. Regul. Serv 2014. New chemical substance notification in China—China REACH Updated April 2014. Chem. Insp. Regul. Serv., Hangzhou, China. http://www.cirs-reach.com/China_Chemical_Regulation/IECSC_China_REACH_China_New_Chemical_Registration.html [Google Scholar]
  11. 11.  Corrosion Proof Fittings v. EPA, 947 F.2d 1201, 5th Cir. (1991)
  12. Cox LA, Popken D, Marty MS, Rowlands JC, Patlewicz G. 12.  et al. 2014. Developing scientific confidence in HTS-derived prediction models: lessons learned from an endocrine case study. Regul. Toxicol. Pharmacol. 69:3443–50 [Google Scholar]
  13. Cranor CF. 13.  2006. Toxic Torts: Science, Law and the Possibility of Justice Cambridge, UK: Cambridge Univ. Press [Google Scholar]
  14. Cranor CF. 14.  2011. Legally Poisoned: How the Law Puts Us At Risk from Toxicants Cambridge, MA: Harvard Univ. Press [Google Scholar]
  15. Cranor CF. 15.  2013. Milward v. Acuity Specialty Products: advances in general causation testimony in toxic tort litigation. Wake Forest J. Law Policy105–39 [Google Scholar]
  16. Denison R. 16.  2009. Talk about over-reaching: Anti-REACH screed gets nearly everything wrong Posted Aug. 26. Environ. Def. Fund, Washington, DC. http://blogs.edf.org/health/2009/08/26/talk-about-over-reaching-anti-reach-screed-gets-nearly-everything-wrong/ [Google Scholar]
  17. 17. ECHA 2009. New study inaccurate on the number of test animals for REACH ECHA Press Release Aug. 28. Eur. Chem. Agency, Helsinki. http://apps.echa.europa.eu/legacy/doc/press/pr_09_11_animal_testing_20090828.pdf [Google Scholar]
  18. 18. ECHA 2014. Authorisation Eur. Chem. Agency, Helsinki. http://echa.europa.eu/web/guest/regulations/reach/authorisation [Google Scholar]
  19. 19. ECHA 2014. Candidate list of substances of very high concern for authorisation Eur. Chem. Agency, Helsinki. Updated June 16. http://echa.europa.eu/web/guest/candidate-list-table [Google Scholar]
  20. 20. ECHA 2014. Target met for 5% compliance checks of the 2010 registration dossiers ECHA Press Release Jan. 15. Eur. Chem. Agency, Helsinki. http://echa.europa.eu/view-article/-/journal_content/title/target-met-for-5-percent-compliance-checks-of-the-2010-registration-dossiers [Google Scholar]
  21. 21. EDF (Environ. Def. Fund) 1997. Toxic Ignorance: the Continuing Absence of Basic Health Testing for Top-Selling Chemicals in the United States New York: EDF http://www.edf.org/sites/default/files/243_toxicignorance_0.pdf [Google Scholar]
  22. Eriksson J, Gilek M, Ruden C. 22.  2010. Regulating Chemical Risks: European and Global Challenges Dordrecht: Springer [Google Scholar]
  23. 23. Eur. Comm 2014. The Transatlantic Trade and Investment Partnership (TTIP) regulatory issues: EU position on chemicals. Updated May 2014. Eur. Comm. http://trade.ec.europa.eu/doclib/docs/2014/may/tradoc_152468.pdf [Google Scholar]
  24. 24. Eur. Union 2008. European Parliament (C-14/06) and Kingdom of Denmark (C-295/06) v. Commission of the European Communities. Judgm. Court (Grand Chamber) 1 April 2008. Off. J. Eur. Union. 2008/C 116/02 [Google Scholar]
  25. Fenner-Crisp P, Maciorowski AF, Timm GE. 25.  2000. The endocrine disruptor screening program developed by the US Environmental Protection Agency. Ecotoxicology 9:85–91 [Google Scholar]
  26. Foley L. 26.  2014. Chemical industry political giving surges Posted May 23. Environ. Work. Group, Washington, DC. http://www.ewg.org/enviroblog/2014/05/chemical-industry-political-giving-surges [Google Scholar]
  27. 27. Galbraith DA, for ChemRisk 2005. Human biomonitoring: an overview Presented at the ISTRP Worksh., June 16, San Francisco [Google Scholar]
  28. 28. GAO (U.S. Gen. Account. Off.) 2005. Chemical Regulation—Options Exist to Improve EPA's Ability to Assess Health Risks and Manage Its Chemical Review Program (GAO-05-458). Washington, DC: GAO [Google Scholar]
  29. Giacomello AM, Guha P, Howe P, Jones KC, Matthiessen P. 29.  et al. 2006. The benefits of chemicals regulation A report to Defra Posted Dec. 2006. REACH Cent., Lancaster, UK. http://www.thereachcentre.com/uploaded/Benefits%20of%20Chemical%20Regulation.pdf [Google Scholar]
  30. Guth JH, Denison RA, Sass J. 30.  2007. Require comprehensive safety data for all chemicals. New Solut. 17:233–56 [Google Scholar]
  31. Hadrup N. 31.  2014. Evidence from pharmacology and pathophysiology suggests that chemicals with dissimilar mechanisms of action could be of bigger concern in the toxicological risk assessment of chemical mixtures than chemicals with a similar mechanism of action. Regul. Toxicol. Pharmacol. 69:3281–83 [Google Scholar]
  32. Hamilton JT. 32.  1995. Pollution as news: media and stock market reactions to the Toxics Release Inventory Data. J. Environ. Econ. Manage. 28:96–113 [Google Scholar]
  33. Hammond E, McGarity T, Shapiro S, Wagner W, Goodwin J. 33.  2013. TSCA reform: preserving tort and regulatory approaches Cent. Progress. Reform (CPR) Issue Alert #1309. Oct. 2013. CPR, Washington, DC. http://www.progressivereform.org/articles/TSCA_IssueAlert_1309.pdf [Google Scholar]
  34. Hansen-Kuhn K, Suppan S. 34.  2013. Promises and Perils of the TTIP Minneapolis, MN: Inst. Agric. Trade Policy http://www.iatp.org/files/2013_10_25_TTIP_KHK.pdf [Google Scholar]
  35. Hartung T. 35.  2009. Toxicology for the twenty-first century. Nature 460:7252208–12 [Google Scholar]
  36. Hartung T, Rovida C. 36.  2009. Chemical regulators have overreached. Nature 460:1080–81 [Google Scholar]
  37. Heinzerling L. 37.  2006. Doubting Daubert. J. Law Policy 14:65–83 [Google Scholar]
  38. James F Jr, Hazard GC Jr. 38.  1977. Civil Procedure. Boston: Little, Brown 2nd ed. [Google Scholar]
  39. Jensen S. 39.  1996. Report of a new chemical hazard. New Sci. 32:612 [Google Scholar]
  40. Judson R, Houck K, Martin M, Knudsen T, Thomas RS. 40.  et al. 2014. In vitro and modelling approaches to risk assessment from the U.S. Environmental Protection Agency ToxCast programme. Basic Clin. Pharmacol. Toxicol. 115:69–76 [Google Scholar]
  41. Judson R, Richard A, Dix DJ, Houck K. 41.  2009. The toxicity data landscape for environmental chemicals. Environ. Health Perspect. 117:685–95 [Google Scholar]
  42. Jurs A, DeVito S. 42.  2013. The stricter standard: an empirical assessment of Daubert's effect on civil defendants. Cathol. Univ. Law Rev. Spring:681–731 [Google Scholar]
  43. Kavlock R, Dix D. 43.  2010. Computational toxicology as implemented by the U.S. EPA: providing high throughput decision support tools for screening and assessing chemical exposure, hazard and risk. J. Toxicol. Environ. Health B. Crit. Rev. 13:2–4197–217 [Google Scholar]
  44. Koch C, Ashford N. 44.  2006. Rethinking the role of information in chemicals policy: implications for TSCA and REACH. J. Clean. Prod. 14:31–46 [Google Scholar]
  45. LaDou J, Castleman B, Frank F, Gochfeld G, Greenberg M. 45.  et al. 2010. The case for a global ban on asbestos. Environ. Health Perspect. 118:897–901 [Google Scholar]
  46. Landrigan PJ, Goldman LR. 46.  2014. Chemical safety, health care costs and the Affordable Care Act. Am. J. Ind. Med. 57:1–3 [Google Scholar]
  47. Li MC, Tsai PC, Chen PC, Hsieh CJ, Leon Guo YL, Rogan WJ. 47.  2013. Mortality after exposure to polychlorinated biphenyls and dibenzofurans: 30 years after the “Yucheng accident.”. Environ. Res. 120:71–75 [Google Scholar]
  48. Long BL. 48.  2000. International Environmental Issues and the OECD, 1950–2000: An Historical Perspective Paris: OECD [Google Scholar]
  49. Markell D. 49.  2010. An overview of TSCA, its history and key underlying assumptions, and its place in environmental regulation. J. Law Policy 32:333–75 [Google Scholar]
  50. McCubbins D, Noll RG, Weingast BR. 50.  1987. Administrative procedures as instruments of political control. J. Law Econ. Organ. 3:2243–77 [Google Scholar]
  51. 51.  Milward v. Acuity Specialty Products Group, 639 F.3d 11, 1st Cir. (2011), rev. 664 F. Suppl. 2d 137, D. Mass. (2009)
  52. Neltner TG, Alger HM, O'Reilly JT, Krimsky S, Bero LA, Maffini MV. 52.  2013. Conflicts of interest in approvals of additives to food determined to be generally recognized as safe: out of balance. JAMA Intern. Med. 173:222032–36 [Google Scholar]
  53. 53. NRC (Natl. Res. Counc.) 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad Washington, DC: Natl. Acad. Press [Google Scholar]
  54. 54. OTA (U.S. Congr., Off. Technol. Assess.) 1987. Identifying and Regulating Carcinogens Washington, DC: U.S. Gov. Print. Off. [Google Scholar]
  55. Porter M, van der Linde C. 55.  1995. Toward a new conception of the environment-competitiveness relationship. J. Econ. Perspect. 9:97–118 [Google Scholar]
  56. Pugh DM, Tarazona JV. 56.  1998. Regulation for Chemical Safety in Europe: Analysis, Comment and Criticism Springer New York: [Google Scholar]
  57. Rechtschaffen C, Williams P. 57.  2005. The continued success of Proposition 65 in reducing toxic exposures. ELR News Anal. 35:10830–56 [Google Scholar]
  58. Reihlen A, Lüskow H. 58.  2007. Analysis of Studies Discussing Benefits of REACH. Hamburg: Inst. Okol. Polit http://ec.europa.eu/environment/chemicals/reach/pdf/background/reach_benefit_studies.pdf [Google Scholar]
  59. Risebrough RW, Walker W 2nd, Schmidt TT, de Lappe BW, Connors CW. 59.  1976. Transfer of chlorinated biphenyls to Antarctica. Nature 264:5588738–39 [Google Scholar]
  60. Roe D. 60.  1989. An incentive-conscious approach to toxic chemical controls. Econ. Dev. Q. 3:179–87 [Google Scholar]
  61. Saks MJ. 61.  1992. Do we really know anything about the behavior of the tort litigation system—and why not?. Pa. Law Rev. 140:1147–292 [Google Scholar]
  62. Schapiro M. 62.  2007. Toxic inaction. Harpers Magazine Oct.:78–83 [Google Scholar]
  63. Schierow LJ. 63.  2009. The Toxic Substances Control Act (TSCA): implementation and new challenges Rep. 7–5700, pp. 1–35. Congr. Res. Serv., Washington, DC [Google Scholar]
  64. Scott RE. 64.  2007. The Walmart effect Posted June 25. Econ. Policy Inst., Washington, DC. http://www.epi.org/publication/ib235/ [Google Scholar]
  65. Shapiro SA, Glicksman RL. 65.  1988. Congress, the Supreme Court, and the quiet revolution in administrative law. Duke Law J. Nov.:839–40 [Google Scholar]
  66. Silbergeld EK. 66.  1993. Risk assessment: the perspective and experience of US environmentalists. Environ. Health Perspect. 101:2100–4 [Google Scholar]
  67. Silbergeld EK. 67.  1997. Preventing lead poisoning in children. Annu. Rev. Public Health 16:187–210 [Google Scholar]
  68. Silbergeld EK. 68.  2004. Commentary: the role of toxicology in prevention and precaution. Int. J. Occup. Med. Environ. Health 17:191–102 [Google Scholar]
  69. 69.  Sindell v. Abbott Lab., 26 Cal 3d 588, 607 P.2d 924 (1980)
  70. Tucker R. 70.  1982. Evaluation of notification data received in the framework of TSCA. Principles for the Interpretation of the Results of Testing Procedures in Ecotoxicology Comm. Eur. Communities 22–29 Luxembourg: Comm. Eur. Communities [Google Scholar]
  71. 71. U.S. DHHS (Dep. Health Hum. Serv.) 2013. Secure supply chain pilot program. Food Drug Adm. Docket No. FDA-2008-N-0656. Fed. Regist 78:51192–94 [Google Scholar]
  72. 72. U.S. EPA (Environ. Prot. Agency) 1994. Joint EPA/EC Joint Project on the Evaluation of (Quantitative) Structure Activity Relationships Paris: OECD [Google Scholar]
  73. 73. U.S. EPA (Environ. Prot. Agency) 2013. Making a finding on unreasonableness of risk. Updated Sept. 15. EPA, Washington, DC. http://www.epa.gov/oppt/newchems/pubs/unrerisk.htm [Google Scholar]
  74. 74. U.S. EPA (Environ. Prot. Agency) 2013. Polymer exemption overview as amended by TSCA PMN Rule Amendments of 1995 Updated Sept. 15. EPA, Washington, DC. http://www.epa.gov/oppt/newchems/pubs/polyexem.htm [Google Scholar]
  75. Valerio LG Jr, Arvidson KB, Chanderbhan RF, Contrera JF. 75.  2007. Prediction of rodent carcinogenic potential of naturally occurring chemicals in the human diet using high-throughput QSAR predictive modeling. Toxicol. Appl. Pharmacol. 222:11–16 [Google Scholar]
  76. 76. Van Heerden 2012. Recent developments in global regulatory framework in the chemical industry. Chem. Ind. Digest June:76–81 [Google Scholar]
  77. Van Leeuwen K, Schultz TW, Henry T, Diderich B, Veith GD. 77.  2009. Using chemical categories to fill data gaps in hazard assessment. SAR QSAR Environ. Res. 20:207–20 [Google Scholar]
  78. Vig N, Kraft M. 78.  2003. Environmental Policy: New Directions for the 21st Century Washington, DC: Congr. Q. Press [Google Scholar]
  79. Vogel D. 79.  2003. The hare and the tortoise revisited: the new politics of consumer and environmental regulation in Europe. Br. J. Pol. Sci. 33:4557–80 [Google Scholar]
  80. Vogel SA, Roberts JA. 80.  2011. Why the Toxic Substances Control Act needs an overhaul, and how to strengthen oversight of chemicals in the interim. Health Aff. 30:5898–905 [Google Scholar]
  81. Waldman P. 81.  2005. Study tied pollutant to cancer; then consultants got hold of it. The Wall Street Journal Dec. 2. http://online.wsj.com/news/articles/SB113530126572230084 [Google Scholar]
  82. Walker D. 82.  2012. Missouri lawyers of the year win $358M toxic tort case. Missouri Lawyers Weekly Jan. 27. http://molawyersmedia.com/2012/01/27/video-missouri-lawyers-of-the-year/ [Google Scholar]
  83. Walker JD, Fang H, Perkins R, Tong W. 83.  2003. QSARs for endocrine disruption priority setting database 2: the integrated 4-phase model. Quant. Struct.-Act Relat. 22:1–17 [Google Scholar]
  84. Zoeller TR, Dowling AL, Herzig CT, Iannacone EA, Gauger KJ, Bansal R. 84.  2002. Thyroid hormone, brain development, and the environment. Environ. Health Perspect. 110:Suppl. 3355–61 [Google Scholar]
/content/journals/10.1146/annurev-publhealth-031914-122654
Loading
  • Article Type: Review Article

Most Cited Most Cited RSS feed

This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error