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Equal Treatment for Regulatory Science: Extending the Controls Governing the Quality of Public Research to Private Research

Published online by Cambridge University Press:  06 January 2021

Wendy Wagner  and
David Michaels
Wendy Wagner
Affiliation:
University of Texas School of Law
David Michaels
Affiliation:
Department of Environmental and Occupational Health, George Washington University School of Public Health and Health Services
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Extract

The imperative that agencies use sound science in developing their regulations has become a major preoccupation of the political branches. In only a few years, Congress passed two appropriations riders that provide extensive new mechanisms for the public to critique the science used by agencies. The executive branch quickly followed suit, promulgating regulations to implement these two laws, as well as proceeding on its own sound science missions. In the space of less than one year, the Office of Management and Budget (OMB) circulated for public comment draft peer review requirements for the scientific review of agency science, and the Environmental Protection Agency (EPA) launched a full scale program to improve the quality of the models it uses in regulation, as well as Assessment Criteria to be used by agency officials in reviewing the quality of third-party (primarily state) science.

Type
Article
Information
American Journal of Law & Medicine , Volume 30 , Issue 2-3 , June 2004 , pp. 119 - 154
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2004

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Footnotes

†

We are most grateful to Aaron Pickell for his invaluable research assistance on TSCA 8(e) submissions.

References

1 These riders are known as the Data Access Act and the Data Quality Act. The Data Access Act (also known as the Shelby Amendment) was passed as a rider to the Omnibus Appropriations Act for Fiscal Year 1999, Pub. L. No. 105-277, 112 Stat. 2681-495 (1998). The Data Quality Act was passed as a rider to an appropriations bill, section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001, Pub. L. No. 106-554, 114 Stat. 2763A-153-55 (2001).

2 OFFICE OF MANAGEMENT AND BUDGET, PEER REVIEW AND INFORMATION QUALITY, PROPOSED BULLETIN (Aug. 2003), available at http://www.whitehouse.gov/omb/inforeg/peer_review_and_info_quality.pdf.

3 See Memorandum from Christine Todd Whitman, Environmental Protection Agency Administrator, to Assistant Administrators, Associate Administrators, Regional Administrators and the Science Policy Council (Feb. 7, 2003), available at http://www.thecre.com/pdf/whitman_memo.pdf.

4 A Summary of General Assessment Factors for Evaluating the Quality of Scientific and Technical Information, 68 Fed. Reg. 39,086 (2003) (announcing the availability of the new guidelines online at http://www.epa.gov/quality/informationguidelines).

5 See Letter from Jim Tozzi, Center for Regulatory Effectiveness, to American Association of University Professors (Aug. 6, 2003), available at http://www.thecre.com.

6 See, e.g., Andrew C. Revkin, Suit Challenges Climate Change Report by U.S., N.Y. TIMES, Aug. 7, 2003, at A21.

7 Part II.B, infra.

8 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. (2000).

9 Toxic Substances Control Act (TSCA), 15 U.S.C. 2601-2629 (2000).

10 See, e.g., FIFRA, 7 U.S.C. 136d(a)(2) (If at any time after the reregistration of a pesticide the registrant has additional factual information regarding unreasonable adverse effects on the environment of the pesticide, the registrant shall submit such information to the Adminstrator.); TSCA, 15 U.S.C. 2607 (c), (e) (same); id. 2604(b) (requiring premarket toxicity testing as a condition to registration of new pesticides).

11 See, e.g., FIFRA, 7 U.S.C. 136a-1; TSCA, 15 U.S.C. 2603(a).

12 Under FIFRA, the Environmental Protection Agency (EPA) has developed a chart setting out the series of tests that a manufacturer must conduct before a pesticide is permitted to enter the market. See 40 C.F.R. pt. 158 (2003) (setting forth a basic core set of more than 100 studies that would assist in determining the effects of pesticides); Id. 158.340 (providing a table for all testing requirements and guidelines under FIFRA). Not all of these tests specify rigid testing protocols, however. See, e.g., 40 C.F.R. 158.290, 158.490, 158.590 (testing to determine respectively the environmental fate of pesticides, impacts on wildlife, and effects on nontarget insects).

13 The extent of private science underlying our scientific understanding of toxic substances has not been systematically studied or documented. Anecdotal accounts, however, reveal that a significant portion of research used to regulate products is industry-sponsored. See, e.g., U.S. ENVIRONMENTAL PROTECTION AGENCY, INTEGRATED RISK INFORMATION SYSTEM, ATRAZINE, at http://www.epa.gov/iris/subst/0209.htm (last updated July 12, 2004) (showing EPA's Integrated Risk Information System or IRIS databases identifying nine studies available on the oral dose toxicity of atrazine, eight of which were conducted by Ciga-Geigy Corp. and the ninth was indeterminate with regard to sponsor) [hereinafter ATRAZINE]; see also SHELDON KRIMSKY, SCIENCE IN THE PRIVATE INTEREST: HAS THE LURE OF PROFITS CORRUPTED THE VIRTUE OF BIOMEDICAL RESEARCH? 146 (2003) (observing that [a]mong the tens of thousands of clinical trials occurring each year, most are funded by for-profit companies seeking to gain FDA approval for new drugs, clinical procedures, or medical devices.).

14 See, e.g., ROBERT K. MERTON, The Normative Structure of Science, in THE SOCIOLOGY OF SCIENCE: THEORETICAL AND EMPIRICAL INVESTIGATIONS 267, 275 (J. Guston ed., 1973) (identifying honesty, objectivity, and disinterestedness as norms constituting the universal methods of science).

15 See Wendy, E. Wagner, Choosing Ignorance in the Manufacture of Toxic Products, 80 CORNELL L. REV. 773 (1997)Google Scholar.

16 See Wendy E. Wagner, Commons Ignorance: How the Environmental Laws Have Failed Us, __DUKE L.J. __ (forthcoming 2004).

17 See, e.g., False Statements Accountability Act of 1996, 18 U.S.C. 1001 (2000) (providing for fines or imprisonment for falsification or concealment of material facts from the federal government).

18 See Thomas, O. McGarity, Beyond Buckman: Wrongful Manipulation of the Regulatory Process in the Law of Torts, 41 WASHBURN L.J. 549, 562 (2002)Google Scholar (describing incidents of forged toxicology reports required under FIFRA). For other incidents of fraudulent or misleading reports and data submitted to regulatory agencies under the Food Drug and Cosmetic Act, see id. at 559-63. Additionally, in an older study of Food and Drug Administration (FDA) audits of clinical research on drugs, between 7 and 12% of the research sampled revealed serious deficiencies in the research, some of which involved made-up data and research fraud.

19 Id. at 562.

20 30 U.S.C. ch. 22 (2000).

21 See id. 813, 842-43.

22 See id. 813, 814(f).

23 James L.Weeks. The Fox Guarding the Chicken Coop: Monitoring Exposure to Respirable Coal Mine Dust, 1969-2000, 93 AM. J. PUB. HEALTH 1236 (2003).

24 Professor Krimsky endeavors to isolate this type of ends-oriented bias, which appears to affect the outcome of the research in statistically significant ways. See generally KRIMSKY, supra note 13, at 141-44; see also Sidney A. Shapiro, Divorcing Profit Motivation from New Drug Research: A Consideration of Proposals to Provide FDA With Reliable Test Data, 1978 DUKE L.J. 155, 163 (discussing this problem in research by drug companies on the safety of drugs); Shankar Vedantam, Antidepressant Makers Withhold Data on Children, WASH. POST, Jan. 29, 2004, at A1.

25 In conducting laboratory tests on the toxicity of a substance, for example, researchers might focus exclusively on recording the tumors (if the experiment is designed to test for cancer) and will not even record or take written notice of other types of surprise adverse reactions that occur in the course of the study.

26 See KRIMSKY, supra note 13, at 142-44 (describing the discretionary decisions that arise in conducting studies on the safety and efficacy of drugs); id. at 155-58 (describing evidence of sponsors tweaking the protocols when under legal pressure).

27 See John P.A. Ioannidis & Joseph Lau, Completeness of Safety Reporting in Randomized Trials: An Evaluation of 7 Medical Areas, 285 JAMA 437 (2001).

28 See generally DAN FAGIN & MARIANNE LAVELLE, TOXIC DECEPTION: HOW THE CHEMICAL INDUSTRY MANIPULATES SCIENCE, BENDS THE LAW, AND ENDANGERS YOUR HEALTH 33-50 (1996) (discussing evidence of fraud and bias in industry-conducted or sponsored studies on the safety of substances).

29 See KRIMSKY, supra note 13, at 145-50, 154, 158 (discussing numerous studies finding a funding effect published in the Journal of General Internal Medicine, British Medical Journal, New England Journal of Medicine, and the Journal of the American Medical Association); Joel Lexchin et al., 326 BRIT. MED. J. 1167-76 (2003).

30 Justin E. Bekelman et al., Scope and Impact of Financial Conflicts of Interest in Biomedical Research: A Systematic Review, 289 JAMA 454, 463 (2003).

31 See Deborah, Barnes & Lisa, Bero, Scientific Quality of Original Research Articles on Tobacco Smoke, 6 TOBACCO CONTROL 19 (1997)Google Scholar.

32 See KRIMSKY, supra note 13, at 147.

33 One of the editors of the Journal of the American Medical Association has argued that ghost-writing is occurring in biomedical articles at an alarming pace. Companies will pay the big names to appear on the byline in place of the ghostwriters, who contribute only their prestige to the study. Drummond Rennie et al., When Authorship Fails: A Proposal to Make Contributors Accountable, 278 JAMA 579, 580 (Aug. 20, 1997); see also Antony Barnett, Revealed: How Drug Firms Hoodwink Medical Journals, OBSERVER, Dec. 7, 2003, available at http://observer.guardian.co.uk/uk_news/story/0,6903,1101680,00.html.

As a result, some prominent research journals refuse to publish literature reviews or editorials where the author has a conflict of interest in the outcome, since the extent and effect of the bias is difficult to detect through the usual methods of replication and validation familiar to science. See, e.g., INTERNATIONAL COMMITTEE OF MEDICAL JOURNAL EDITORS, UNIFORM REQUIREMENTS FOR MANUSCRIPTS SUBMITTED TO BIOMEDICAL JOURNALS, at http://www.icmje.org (last updated Nov. 2003) (Editors may use information disclosed in conflict of interest and financial interest statements as a basis for editorial decisions.).

34 See, e.g., Rennie et al., supra note 33, at 580 (observing that [r]epeated publication of the same work, with or without minor additions, inflates bibliographies and is common. When similar parts of the same trial are published repeatedly under different authors names, without crossreferencing, the record is distorted in the name of promotion, and meta-analysis is confounded to the detriment of care.); Drummond, Rennie, Fair Conduct and Fair Reporting of Clinical Trials, 282 JAMA 1766, 1766 (1999)Google Scholar (discussing specific examples of the over-publication of and failure to cross-reference to clinical trials).

35 See, e.g., Joseph, Sanders, The Bendectin Litigation: A Case Study in the Life Cycle of Mass Torts, 43 HASTINGS L.J. 301, 337 (1992)Google Scholar (describing Merrell's research conducted after litigation in Bendectin cases as a lose-lose proposition because [i]f they showed an effect, the studies would be used against the company and if they did not [a]ny slight technical flaw in the design or execution of the experiment would be exploited by plaintiffs to undermine Merrell's findings).

36 See, e.g., Deborah E. Barnes and Lisa Bero, Industry-Funded Research and Conflict of Interest: An Analysis of Research Sponsored by the Tobacco Industry through the Center for Indoor Air Research, 21 J. HEALTH POL. POLY & L. 515-42 (1996); Alicia Mundy, Hot Flash, Cold Cash, WASH. MONTHLY, Jan. 1, 2003, at 35 (reporting on drug companies influence on a nonprofit called The Society for Women's Health Research, which includes substantial corporate giving and representation on corporate board; this influence is ultimately reflected in the Society's position on various issues).

37 The skillful use of review articles has been identified as one strategy used by at least the tobacco industry. Deborah, E. Barnes & Lisa, A. Bero, Why Review Articles on the Health Effects of Passive Smoking Reach Different Conclusions, 279 JAMA 1566 (1998)Google Scholar (finding that the most strongly supported explanation for the discrepancy in reviews assessing the impact of passive smoking was whether or not they were written by authors affiliated with the tobacco industry). The creation of hand-picked or stacked expert panels is even more commonplace. See, e.g., STANTON GLANTZ ET AL., THE CIGARETTE PAPERS 32-33 (1996) (summarizing that Tobacco Industry Research Committee (TIRC, later named Council for Tobacco Research (CTR)) was formed jointly by tobacco companies with the publicly identified purpose of fund[ing] independent scientific research on hazards of cigarettes, while internal documents reflect its true purpose was for public relations to convince the public that the hazards of smoking had not been definitively proven); RICHARD KLUGER, ASHES TO ASHES: AMERICA's HUNDRED-YEAR CIGARETTE WAR, THE PUBLIC HEALTH, AND TEH UNABASHED TRIUMPH OF PHILIP MORRIS 164-67, 205-12, 227-29, 466-68 (1996) (describing the activities and mission of the tobacco industry's TIRC/CTR); ALICIA MUNDY, DISPENSING WITH THE TRUTH: THE VICTIMS, THE DRUG COMPANIES, AND THE DRAMATIC STORY BEHIND THE BATTLE OVER FEN-PHEN 119 (2001) (discussing how the manufacture of Fen-Phen convened an expert panel to review the drug, but how many of the experts selected had allegiances to the company).

38 See Sameer, S. Chopra, Industry Funding of Clinical Trials: Benefit or Bias?, 290 JAMA 113, 113-14 (2003)Google Scholar, available at http://jama.ama-assn.org/cgi/reprint/290/1/113.pdf (discussing researcher biases that can influence the interpretation of clincial research results).

39 See, e.g., Goldie Blumenstyk, The Price of Research, CHRON. HIGHER ED., Oct. 31, 2003, available at http://chronicle.com/free/v50/i10/10a02601.htm (discussing how industry sponsor of herbiciderelated research attempted to delay publication of the adverse results, at least according to the researcher).

40 See, e.g., Bruce, M. Psaty & Drummond, Rennie, Stopping Medical Research to Save Money: A Broken Pact with Researchers and Patients, 289 JAMA 2128, 2128-29 (2003)Google Scholar (discussing the efforts of Apotex Inc. to conceal research, including the halting of two trials under a confidentiality clause and issuing legal warnings under the guise of confidentiality to prevent the prinicipal investigator from publishing the study results or disclosing risks to patients).

41 See, e.g., MUNDY, supra note 37, at 133-34 (citing attempts to conceal how many reports of pulmonary hypertension Fen-Phen received); FAGIN & LAVELLE, supra 28, at xxi (discussing the ability of the tabacco companies to mislead the public and keep their products on the shelves despite mouting evidence as to the harmful nature of those products); SHELDON RAMPTON & JOHN STAUBER, TRUST US, WERE EXPERTS (2001) (describing, through a number of case studies, how the tobacco companies used third-party public relations consultants to distance them from misleading information about their activities).

42 See West v. Johnson & Johnson Prods., Inc., 220 Cal. Rptr. 437, 445 (Cal. Ct. App. 1985) (discussing the company's reception of consumer complaints and information that would not ordinarily be available to third parties).

43 A.H. Robins, the manufacturer of the Dalkon Shield, actively concealed the adverse results from the very limited safety testing it did conduct. See, e.g., Tetuan v. A.H. Robins Co., 738 P.2d 1210, 1240 (Kan. 1987) (awarding punitive damages based on corporate misconduct, including evidence that A.H. Robins commissioned studies on the Dalkon Shield which it dropped or concealed when the results were unfavorable and consigned hundreds of documents to the furnace). Cf. MORTON MINTZ, AT ANY COST: CORPORATE GREED, WOMEN, AND THE DALKON SHIELD 122 (1985) (referencing memo by Kenneth Moore, Project Coordinator of Robins's Dalkon Shield, reporting that Robins's main purpose in funding research was to make available for publication extremely good Dalkon Shield results). For example, Robins initiated a two-year study that was never made available to the medical profession on the effects of the Dalkon Shield on baboons eight months after it started selling the product. Among eight [of the baboons tested], one perished, and among ten, three suffered perforation of the uterus . Id. at 123 (quoting testimony of Dr. John W. Ward, Director of Toxicology and Assistant Director of Scientific Development). Following an escalation of concern by company employees over the potential of Dalkon Shield's string to carry bacteria from the vagina to the uterus, Robins retrieved 303 used strings for examination by a staff scientist, Dr. Thomas C. Yu. Dr. Yu found defects in all but 35 of the strings. Dr. Yu's boss swore that Robins maintained no written records of the exams or the results. Id. at 134-35. There is also some suggestion that Robins destroyed sensitive Dalkon Shield documents in order to better defend against litigation. See Francine Schwadel, Robins and Plaintiffs Face Uncertain Future: Chapter 11 Filing Postpones 5,100 Dalkon Shield Cases, WALL ST. J., Aug. 23, 1985, at 4.

44 Merrell Dow's culpability in the controversial breast implant litigation was in large part due to its stubborn refusal to research the adverse effects of silicone in the body cavity (even at the insistence of the Food and Drug Administration), in light of their own preliminary and secret in-house evidence suggesting that the implants were leaking and harmful. See, e.g., Hopkins v. Dow Corning Corp., 33 F.3d 1116, 1127-28 (9th Cir. 1994) (affirming punitive damage award based in part on evidence that company concealed adverse results of clinical studies and knew that long-term studies were needed). In Hopkins, the court stated:

Dow obtained results of a study in which four dogs received silicone gel implants that resembled the implants that Dow was then marketing. The results demonstrated that after six months, the implants appeared to be functioning properly, but that after two years, inflammation surrounding the implants demonstrated the existence of an immune reaction. Dow did not publicly release the results of this research for several years, and when it did ultimately release the results, Dow omitted the negative findings and implied that the implants were safe.

Id. at 1119; see also Rebecca Weisman, Reforms in Medical Device Regulation: An Examination of the Silicone Gel Breast Implant Debacle, 23 GOLDEN GATE U. L. REV. 973, 987 n.122 (1993) (quoting Dow Corning discovery documents and summary of scientific studies). Dow Corning also conducted a study in 1974 that revealed that silicone could trigger strong reactions of the immune system, but Dow Corning denied such a reaction at an FDA hearing in 1991. Id. at 988 n.123. Finally, in 1987 Dow Corning was aware that some of its employees had falsified documents regarding silicone breast implants, but Dow Corning did not alert the FDA to these misstatements until 1992. See id.

45 The record of asbestos manufacturers attempt to conceal or downplay the hazards of asbestos is well documented. See generally PAUL BRODEUR, OUTRAGEOUS MISCONDUCT: THE ASBESTOS INDUSTRY ON TRIAL (1985) (chronicling asbestos litigation throughout the industry). Some of the more dramatic examples include animal studies on asbestosis in the 1930s, the findings of which, by agreement, belonged to the investors until they agreed to disclose them to the public, notes detailing Johns-Manville Co.'s health review committee meeting during which executives developed a corporate policy of not informing sick employees of the precise nature of their health problems for fear of workmens-compensation claims and lawsuits, and successful company efforts to persuade the editor of a trade magazine that growing scientific studies on asbestos [should] receive the minimum of publicity. Id. at 116-17, 118-19, 145.

46 See GERALD MARKOWITZ & DAVID ROSNER, DECEIT AND DENIAL: THE DEADLY POLITICS OF INDUSTRIAL POLLUTION (2002).

47 The tobacco industry vigorously concealed both its research on the carcinogenic and on the addictive properties of cigarettes. See, e.g., GLANTZ ET AL., supra note 37, at 15 (concluding that by the early 1960s Brown & Williamson Tobacco Company and its parent, British American Tobacco, had developed a sophisticated understanding of nicotine pharmacology but did not disclose this understanding to consumers); id. at 58-107 (outlining documentary evidence of industry's knowledge of and research on addictive properties of nicotine); PHILIP J. HILTS, SMOKESCREEN: THE TRUTH BEHIND THE TOBACCO INDUSTRY COVER-UP 38-40 (1996) (describing cover-up of rich research conducted internally on carcinogenic properties of cigarettes and Brown & Williamson's document retention policy that involved shipping all of this research and underlying documentation out of country).

48 See, e.g., Eliot, Marshall, Buried Data Can Be Hazardous to a Company's Health, 304 SCIENCE 1576 (2004)Google Scholar. For the scientific and medical community's demands for a public registry of all clinical trials, see Andrew, Herxheimer, Open Access to Industry's Clinically Relevant Data, 329 BRIT. MED. J. 64 (2004)Google Scholar. See American Medical Association, American Medical Association Recommends that DHHS Establish a Registry for all U.S. Clinical Trials, at http://www.amaassn.org/ama/pub/article/1616-8651.html (June 15, 2004).

49 Frank, Davidoff, New Disease, Old Story, 129 ANNALS INTERNAL MED. 327-28 (1998)Google Scholar. A university-based researcher found a new form of interstitial lung disease, flock worker's lung, and its capacity to affect as many as 2,500 persons employed by the nylon flocking industry in the United States. The company and the researcher's university attempted to suppress the findings; with the university responding by eliminating the occupational medicine unit and deciding not to renew the lead researcher's employment contract. See generally Wade, Roush et al., Publishing Sensitive Data: Who Calls the Shots, 276 SCIENCE 523 (1997)Google Scholar (confidentiality agreement between researcher and textile company used to suppress data showing adverse effects on workers).

50 See infra Section III.A.

51 See, e.g., KRIMSKY, supra note 13, at 144 (describing the differences that could lead to bias in industry-sponsored research relative to publicly funded research).

52 See supra notes 29 and 30 and accompanying text.

53 See, e.g., Wendy E. Wagner, The Bad Science Fiction: Reclaiming the Debate over the Role of Science in Public Health and Environmental Regulation, 66 LAW & CONTEMP. PROBS 63, pt II (2003).

54 See Lars, Noah, Scientific Republicianism: Expert Peer Review and the Quest for Regulatory Deliberation, 49 EMORY L.J. 1033, 1034-35 (2000)Google Scholar (discussing Congress use of peer review to improve agency decision-making).

55 Lawrence Kaplan, Annotation, What Constitutes Trade Secrets and Commericial or Financial Information Obtained from Person and Privileged or Confidential, Exempt from Disclosure Under Freedom of Information Act (5 U.S.C.A. 552(b)(4)), 139 A.L.R. FED. 225 (1997).

56 See Public Information and Confidentiality Regulations, 59 Fed. Reg. 60,446, 60,446- 60,447 (Nov. 23, 1994) (The [Environmental Protection] Agency collects chemical, process, waste stream, financial, and other data from tens of thousands of facilities in many sectors of American business. Companies frequently consider this information vital to their competitive position, and claim it as confidential business information (CBI)).

57 See generally PROTECTION OF SENSITIVE BUSINESS INFORMATION AT THE ENVIRONMENTAL PROTECTION AGENCY 1 (ROPES & GRAY 1998) (describing the mosaic effect) [hereinafter PROTECTION].

58 See, e.g., EPA, PESTICIDES: FREEDOM OF INFORMATION ACT (FOIA), CONFIDENTIAL BUSINESS INFORMATION (CBI) REVIEW, at http://www.epa.gov/pesticides/foia/cbi.htm (last updated July 9, 2004) (listing environment-related information that is commonly claimed as confidential) [hereinafter PESTICIDES: FREEDOM OF INFORMATION ACT]. The Occupational Safety and Hazard Administration (OSHA) also allows employers to withhold information on chemical identities from employees by claiming they are trade secret protected, as long as they indicate they have done so on the label. See 29 C.F.R. 1910.1200(i) (2003).

59 See 40 C.F.R. 2.204(c), 2.204(d) (2003). The EPA has promulgated categorical denials of confidential business information (CBI) for certain types of information (i.e., permit applications for National Pollutant Discharge Elimination System permits under the Clean Water Act) which presumably deter such claims and apply immediately. See, e.g., id. 122.7(b) (2003) (identifying narrow categories for which claims of confidentiality will be denied).

60 See id. 2.204(a); Public Information and Confidentiality, 65 Fed. Reg. 80,394, 80,395 (Dec. 21, 2000) (observing that CBI regulations generally do not require a business to submit a substantiation until disclosure becomes an issue). Generally, it appears that a Freedom of Information Act (FOIA) request serves as the impetus for the EPA to review a CBI claim. See, e.g., id. (EPA often finds it necessary to make final confidentiality determinations as a result of FOIA requests or rulemaking.). In 1994, EPA reported that it received more than 40,000 FOIA requests a year, many of which sought confidential business information. See EPA, Public Information and Confidentiality Regulations, 59 Fed. Reg. 60,446, 60,447 (Nov. 23, 1994). Nonetheless, EPA aggressively challenged more than 700 CBI claims under TSCA in 1990 on its own (without a FOIA trigger) and appeared to make substantial headway in reducing the number of over-inclusive claims. See Julie Yang, Note, Confidential Business Information Reform under the Toxic Substances Control Act, 2 ENVTL. L. 219, 235 (1995) (reporting and documenting this development). The literature does not reveal whether EPA has been able to keep up with this internal review effort since 1990.

61 See, e.g., PESTICIDES: FREEDOM OF INFORMATION ACT, supra note 58; HAMPSHIRE RESEARCH ASSOCIATES, INC., INFLUENCE OF CBI REQUIREMENTS ON TSCA IMPLEMENTATION 18-19 (1992) [hereinafter HAMPSHIRE STUDY]

62 Since trade secret protections are a general common law construct, Congress has authority to balance them against other goals, including health and environmental protection. Although the balancing is struck differently in the various environmental statutes, Congress has indicated that the balance should favor the general disclosure of information needed to determine potential adverse public health and environmental effects. See, e.g., FIFRA, 7 U.S.C. 136h(d) (2000); TSCA, 15 U.S.C. 2613(b) (2000).

63 See 40 C.F.R. 2.203 (2003).

64 See generally 40 C.F.R. 2.201-2.310 (2003). Cf. 40 C.F.R. 350.7(c) (2003) (presenting a contrasting approach to CBI taken under the Emergency Planning and Community Right-to-Know Act (EPCRA)).

65 See generally 40 C.F.R. 2.201-2.310; see also Christopher, J. Lewis, Comment, When Is a Trade Secret Not So Secret?: The Deficiencies of 40 C.F.R. Part 2, Subpart B, 30 ENVTL. L. 143, 171-72 (2000)Google Scholar (making this same observation regarding the lack of disincentives for overbroad CBI claims). For a contrasting approach under EPCRA, see 42 U.S.C. 11045(d)(1) (2000) (outlining a contrasting approach whereby the EPA can assess 25,000 for each frivolous claim).

66 40 C.F.R. 2.203(c) (2003). Once the information is publicly disseminated, the company loses its right to claim misappropriation of a trade secret. James T. OReilly, Seeking a Truce in the Environmental Information Wars: Replacing Obsolete Secrecy Conflicts with New Forms of Sharing, 30 ENVTL. L. REP. 10203, 10204 (2000) (discussing this point and concluding that [t]his threat of income loss provides the economic incentive that motivates industry to oppose agencies broader dissemination of industry-submitted technological and process data).

67 For example, firms have argued in opposing CBI reforms that the internal analysis required for some form of upfront substantiation of trade secret claims (i.e., determining what internal information is legitimately trade secret protected and what is not) is so time-consuming that it might violate the Regulatory Flexibility Act due to the added burden the requirement would impose on small manufacturers. It is far less costly, they argue, to err on the side of over-claiming. See, e.g., Letter from Warren E. Stickle, President, Chemical Producers and Distributors Association, & Bill Balek, President, International Sanitary Supply Association, to EPA (June 13, 2001), available at http://www.cpda.com/Content/regulatory_affairs/archived/regulatory_affairs_archived_material.cfm. At the same time, EPA's administrative costs appear quite substantial. See, e.g., Mary, L. Lyndon, Secrecy and Innovation in Tort Law and Regulation, 23 N.M.L. REV. 1, 34-36 (1993)Google Scholar.

68 See generally GENERAL ACCOUNTING OFFICE, TOXIC SUBSTANCES CONTROL ACT: LEGISLATIVE CHANGES COULD MAKE THE ACT MORE EFFECTIVE, GAO/RCED-94-103, at 54-61 (Sept. 26, 1994) (discussing how the scientific community and others would benefit from lower cost access to TSCA data that is claimed CBI) [hereinafter TOXIC SUBSTANCES CONTROL ACT]; Susan, D. Carle, Note, A Hazardous Mix: Discretion to Disclose and Incentives to Suppress Under OSHA's Hazard Communication Standard, 97 YALE L.J. 581, 596-600 (1988)Google Scholar (discussing manufacturers tendency to claim product ingredients as trade secret protected under OSHA, making OSHA's hazard communication standard, which provides warnings to workers, effectively unenforceable).

As a result, a CBI claim raises the search costs for others to access the information, in some cases so substantially that interested parties will invest neither the money nor the time in obtaining the information or in learning how they might obtain it.

69 For these and other scientific costs that flow from CBI claims, see Lyndon, supra note 67, at 34-39.

70 The statute was read to foreclose allowing state officials to access information claimed as CBI. TSCA, 15 U.S.C. 2613(a) (2000). EPA has worked to provide states access through the contractors provision of TSCA. Id. 2613(a)(2); see Yang, supra note 60, at 232.

71 See, e.g., OReilly, supra note 66, at 10204. Both EPA employee access and EPA contractor access to formula and process data was sharply curtailed [after the 1976 Polaroid hearing], and the system's cumbersome operation provided frequent Federal Register notices when documents were shared with EPA contractors. Id. at 10206. As a result, some of this information is likely missed or proves practicably unobtainable to agency regulators or their citizen-oriented watchdogs because of the impediments to accessing it. See, e.g., Access to Confidential Business Information by Syracuse Research Corporation, 65 Fed. Reg. 11,777 (Mar. 6, 2000) (giving notice of access to CBI data for contractor who will use the CBI data to conduct risk assessments and related studies on health hazards).

72 See, e.g., TOXIC SUBSTANCES CONTROL ACT, supra note 68, at 5:1; see also HAMPSHIRE STUDY, supra note 61, at 26-27 (observing the extraordinarily limited access to CBI; [e]ven typewriter ribbons must be secured until they are destroyed).

73 Id. at 35.

74 Id.

75 This possibility is further reinforced by the grounds that industry sometimes gave for claiming as CBI health and safety studies reported under section 8(e) of TSCA. See HAMPSHIRE STUDY, supra note 61, at 18-19.

76 HAMPSHIRE STUDY, supra note 61.

77 Id. at 28-32.

78 Id. at 31.

79 The Hampshire Study researchers observe:

In the nearly fifteen years that this regulatory effort has been under way, public participation has been minimal, reflecting the fact that EPA has been unable to publicly release the analytical documents that support its regulatory decisions, particularly with regard to asbestos economics and potential substitute materials. This situation clearly illustrates the infectious nature of CBI, in that even governmentconducted analyses that rely on CBI materials themselves become CBI. It further demonstrates the potential for CBI claims to have fundamental impacts on the regulatory process, precluding effective public oversight.

Id. at 32.

80 See id. at 17.

81 Id.

82 Id. at 17 (reporting that except for the 8(d)/8(e) Challenge Program and challenges the vast majority of claims submitted are not reviewed).

83 See Trade Secret Act, 18 U.S.C. 1905 (2000). Resource Conservation and Recovery Act and EPCRA also provide sanctions for persons who disclose trade secret information but are not employees of the government. TSCA, 15 U.S.C. 2613 (2000); RCRA, 42 U.S.C. 6927(b)(2) (2000); EPCRA, 42 U.S.C. 11045(d)(2) (2000); see also Clean Air Act, 42 U.S.C. 7414(c) (2000).

84 See, e.g., Chrysler Corp. v. Brown, 441 U.S. 281 (1979).

85 See, e.g., Ruckelshaus v. Monsanto Co., 467 U.S. 986 (1984) (finding a partial property right entitled to compensation as a result of EPA's disclosure of health and safety studies on company's pesticide).

86 See, e.g., 40 C.F.R. 350.11(b)(1) (2003) (providing person requesting information under FOIA thirty days to appeal to federal court a decision denying the request on the ground the information is CBI).

87 40 C.F.R. 2.205(c) (2003) (giving a company's substantiation for a CBI claim automatic confidential treatment); see also 65 Fed. Reg. 80,394, 80,396 (Dec. 21, 2000) (conceding potential problems with EPA's policy of automatically classifying substantiations as CBI if the firm requests them, which in turn deprives FOIA requestors of not only the information, but the basis for the CBI claim that prohibits its disclosure).

88 See Lyndon, supra note 67, at 35.

89 It has been suggested by a FOIA expert that the agency will avoid this information as much as possible because it wants to avoid both types of lawsuits. See, e.g., OReilly, supra note 66, at 10208 (A possible trend in administrative agency data collection may be the conscious decision to avoid collecting CBI where the access to such information ties up the agency in disputes over the post-collection disclosure of the CBI.).

90 EPA openly concedes that the problem of overbroad CBI claims is serious:

EPA receives a large number of submissions of various types of information claimed as CBI. Many of the claims received are very broad, and the Agency has limited resources to deal with this stream of information. As a result, large amounts of information claimed as CBI are retained by the Agency longer than necessary, and broad or non-specific CBI claims may limit public access to information that is not actually CBI. Public Information and Confidentiality: Advance Notice of Proposed Rulemaking; Withdrawal of 1994 Proposed Rule, 65 Fed. Reg. 80,394, 80,395 (Dec. 21, 2000); see, e.g., HAMPSHIRE STUDY, supra note 61, at 7, 19, 21, 24, 41 (discussing the sharp increase in claims when substantiation is not required over time and across statutes, and concluding that all available evidence supports the proposition that much of the information covered by CBI claims is not legitimately entitled to protection as TSCA CBI.

Public Information and Confidentiality: Advance Notice of Proposed Rulemaking; Withdrawal of 1994 Proposed Rule, 65 Fed. Reg. 80,394, 80,395 (Dec. 21, 2000); see, e.g., HAMPSHIRE STUDY, supra note 61, at 7, 19, 21, 24, 41 (discussing the sharp increase in claims when substantiation is not required over time and across statutes, and concluding that “all available evidence supports the proposition that much of the information covered by CBI claims is not legitimately entitled to protection as TSCA CBI”).

The General Accounting Office (GAO) reports that the Hampshire Study also found that firms claimed as CBI under TSCA information that had already been disseminated publicly. For example, information contained elsewhere in newspaper articles and corporate annual reports was submitted as CBI was publicly available information from EPA's Toxics Release Inventory, a system that contains nationwide information on toxic chemicals emitted into the air, ground, and water by manufacturing facilities. TOXIC SUBSTANCES CONTROL ACT, supra note 68, at 56.

91 See, e.g., In re Hercules, Inc., No. TSCA-III-416, 1990 WL 303887 (Apr. 26, 1990).

92 TOXIC SUBSTANCES CONTROL ACT, supra note 70, at 5:2. EPA's limited resources make this approach available only in the short-term, however. Id. EPA also reviewed CBI claims on health and safety studies and found that over one-fifth of the claims had no merit. Id.

93 See, e.g., HAMPSHIRE STUDY, supra note 61, at figs. 2, 6. Under TSCA, premanufacture notification CBI claims do not require upfront substantiation whereas section 8(e) adverse effects reports do require substantiation.

94 See id. at 44-45 (referencing figures 1 and 2).

95 See id. at 53-54 (referring to figures 9 and 10).

96 See, e.g., id. at 12 (observing that [s]ubstantial numbers of CBI claims were asserted for toxicity, exposure, and environmental release data except for the year 1986); id. at 18-19 (recounting specific unjustified instances where industry asserted CBI claims on health and safety studies for reasons that did not relate to trade-secret concerns).

97 See, e.g., 15 U.S.C. 2613(b) (2000); HAMPSHIRE STUDY, supra note 61, at 23-24; see also Thomas O. McGarity & Sidney A. Shapiro, The Trade Secret Status of Health and Safety Testing Information: Reforming Agency Disclosure Policies, 93 HARV. L. REV. 837, 874 (1980) (arguing that TSCA specifically exempt[s] health and safety studies from the protections otherwise afforded to proprietary information).

The Hampshire Study reaches strong conclusions with regard to the frequency of unjustified CBI claims, noting that:

In those cases where EPA has had the resources to evaluate individual CBI claims, it has determined that a significant fraction of the submissions (up to 50 percent or more of Section 8(e) filings) contained invalid CBI claims. When submitters of these claims were challenged, EPA prevailed in every case.

HAMPSHIRE STUDY, supra note 61, at 41.

98 In the GAO's 1994 study, industry commentators who were interviewed accepted the [GAOs] basic finding that the chemical industry does make improper confidentiality claims and needs to address such claims. TOXIC SUBSTANCES CONTROL ACT, supra note 68, at 5:2. They defended their practice of overclaiming under TSCA, however, by arguing that the purpose of TSCA information is to provide EPA with a factual basis for chemical regulation, not to provide a basis for disseminating data on the chemicals to other interested organizations. Id.

99 The Vice President of CropLife (the trade association of the nation's pesticide manufacturers), for example, has observed:

When public access to data and methods is not possible, such as when EPA must rely on proprietary models to perform risk assessments, the Agency must be able to establish, as a matter of public record, that the robustness checks being applied are scientifically sound and that reproducibility is being verified through meaningful, independent validations. [Absent such a showing,] [t]he Agency's decisions will continually be subject to challenge as black box exercises, unless adequate demonstration of the quality, utility, integrity, and objectivity of the information produced by such proprietary models for use in regulation.

Letter from Ray S. McAllister, Vice President, Science & Regulatory Affairs, CropLife America, to Evangeline Tsibris Cummings, Office of Environmental Information, EPA (June 21, 2002) available at http://www.pestlaw.com/x/comments/2002/EPA-20020621A.html see also Letter from Jim Tozzi, Member CRE Board of Advisors, to Evangeline Tsibris Cummings, Officer of Environmental Information, EPA (Mar. 22, 2002), available at http://thecre.com/quality/20020319_cre-epa_dqcomments.html.

100 Over the past decade, EPA has twice attempted to reform the problem of overbroad CBI protections without success. See 65 Fed. Reg. 80,394 (Dec. 21, 2000); 59 Fed. Reg. 60,446 (Nov. 23,1994); Letter from Warren E. Stickle & Bill Balek to EPA, supra note 67; GAO, ENVIRONMENTAL INFORMATION: EPA COULD BETTER ADDRESS CONCERNS ABOUT DISSEMINATING SENSITIVE BUSINESS INFORMATION (June 1999) [hereinafter ENVIRONMENATAL INFORMATION]; TOXIC SUBSTANCES CONTROL ACT, supra note 68; HAMPSHIRE STUDY, supra note 61; see also Yang, supra note 60, at 229-37 (discussing EPA's failed effort to reform CBI under TSCA in 1994); Confidential Business Information Rule on Hold as Regulatory Negotiation Eyed, 26 ENVTL. REP. (BNA) 17 (1995).

EPA has also suggested that firms provide materials accounting to strengthen EPCRA reporting, which would include information on toxic chemicals that enter, are used, and leave the facility. These reforms were similarly opposed and ultimately terminated by industry. See, e.g., ENVIRONMENTAL INFORMATION, supra note 100, at 11, 12 (discussing how industry opposition based on CBI grounds led to the abandonment of this proposal).

101 Industry argues that even more trade-secret protections are needed given the mosaic effectthe ability of competitors to piece together information about their operations from bits of publicly available data. See, e.g., 59 Fed. Reg. at 80,396 (discussing how the regulated community has made the argument that multiple pieces of data which may not qualify individually to be treated as CBI and are made publicly available can be pieced together to reveal a trade secret.); Letter from Warren E. Stickle & Bill Balek to EPA, supra note 67, at 5 (same). In 1998, the law firm of Ropes and Gray prepared a report for the Chemical Manufacturers Association that advocated adoption of a uniform statute that would make it easier for its members to assert confidentiality claims based on the mosaic argument. PROTECTION, supra note 57. Yet their support for the mosaic effect problem was based on a Chemical Manufacturer Association commissioned study that hired someone to recreate one (not clearly random) industry based on the publicly available information. Id.

They also convened a working group to generally discuss the mosaic effect, a discussion that is devoid of concrete examples or evidence. See id. at 97-98. The extent and pervasiveness of the mosaic effect, then is weakly supported at best. Also unclear are the competitive harms that flow from this intelligence gathering. The voluminous report on the mosaic effect does not provide a single example or argument about the potential types of harms resulting from intelligence-gatheringconsultant groups carefully piecing together publicly available information on competitor firms. Id.

In its arguments, moreover, industry ignores the scientific benefits of disclosure and assumes that the only social value to disclosure is the public's right to know the risks to which they are exposed. See id. at 107 (observing EPA's lack of CBI protection for some data cannot be justified by its right to know mission). See generally id. at 5.

102 See infra Section III.B.2.

103 See, e.g., ATRAZINE, supra note13.

104 Administrative Procedure Act (APA), 5 U.S.C. 706(2)(A) (2000).

105 See supra note 12 and accompanying text. Cf. EPA's Good Laboratory Practices, 40 C.F.R. pt. 160 (providing general requirements for good lab practices for research submitted to EPA; these requirements still leave researchers with considerable research discretion in the design and reporting of most individual research projects).

106 See Shelby Amendment, Pub. L. No. 105-277, 112 Stat. 2681-495 (1998).

107 See OMB Circular A-1110, Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations, 64 Fed. Reg. 54,926, 54,927 (Oct. 8, 1999) ([I]n response to a Freedom of Information Act (FOIA) request for data relating to published research findings produced under an award that were used by the Federal Government in developing policy or rules, the Federal awarding agency shall, within a reasonable time, obtain the requested data so that they can be made available to the public through the procedures established under the FOIA.).

108 See OMB, Final Revision, OMB Circular A-110, 64 Fed. Reg. at 54,929 (requiring research findings to be produced if they were produced under an award that [was] used by the Federal Government in developing an agency action that has the force and effect of law).

109 See, e.g., NATIONAL RESEARCH COUNCIL, ACCESS TO RESEARCH DATA IN THE 21ST CENTURY: AN ONGOING DIALOGUE AMONG INTERESTED PARTIES: REPORT OF A WORKSHOP 27 (2002) (the chair of the National Academy of Science committee, Richard Merrill, expressed concern over the fact that the Shelby Amendment is not bilateral in its application since it does not apply to data that [is] generated by private dollars that [is] submitted to support agency decisions.); id. at 16 (reporting that panelist David Hawkins, representative of a public interest advocacy group, criticized the Shelby Amendment for being one-sided because it applies only to federally funded research and not to industry-supported studies that have been submitted on a confidential basis).

110 But see CENTER FOR REGULATORY EFFECTIVENESS, RELATIONSHIPS WITH PRIVATE FUNDING SOURCES, at http://www.thecre.com/access/comments/2-9-7.html (last visited July 20, 2003) (As part of the award process, federal awardees should be required to provide notice to private research partners that sharing data with federally funded researches may subject that data to possible public disclosure.).

111 Richard, Shelby, Accountability and Transparency: Public Access to Federally Funded Research Data, 37 HARV. J. LEGIS. 369, 379 (2000)Google Scholar.

112 Treasury and General Government Appropriations Act for Fiscal Year 2001, Pub. L. No. 106-554, Stat 5658 (2000).

113 See id. 515(a), (b) (stating requirements apply only to information disseminated by Federal agencies).

114 See Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies, 67 Fed. Reg. 369, 377-78 (Jan. 3, 2003) (defining dissemination as agency initiated or sponsored distribution of information to the public [but] does not include[] distribution limited to correspondence with individuals or persons, public filings, or adjudicative processes); NATIONAL ACADEMY OF SCIENCE, ENSURING THE QUALITY OF DATA DISSEMINATED BY THE FEDERAL GOVERNMENT 60 (Mar. 21, 2002), available at http://www7.nationalacademies.org/stl/4-21-02_Transcript.doc [hereinafter NAS DATA QUALITY TRANSCRIPT] (observing that the issuance of a permit constitutes an adjudication under the APA). National Academy of Science, Ensuring the Quality of Data Disseminated by the Federal Government, available at http://www7.nationalacademies.org/stl/4-22-02_Transcript.doc (Mar. 22, 2002) [hereinafter NAS DATA QUALITY TRANSCRIPT DAY 2] (expressing concern that the agency reach[es] into the open literature for information that it will use in making a pesticide decision and that though that literature may be peer reviewed, we believe [it] complies with a much lower quality of standards in terms of transparency and reproducibility to trump the data produced under higher quality standards by manufacturers in making a pesticide decision).

115 See Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies, 67 Fed. Reg. 369, 377-78 (Jan. 3, 2003) (defining dissemination as agency initiated or sponsored distribution of information to the public [but] does not include distribution limited to correspondence with individuals or persons, public filings, or adjudicative processes).

116 See 67 Fed. Reg. 369, 374 (listing requirements that data and methods be made publicly available does not override other compelling interests such as privacy, trade secrets, intellectual property, and other confidentiality protections); see also NAS, DATA QUALITY TRANSCRIPT, DAY 2, supra note 114, at 128-29 (noting Dr. Galson's statement that FDA approvals are largely based on industry generated data and that much of this is considered confidential business information. It is closely held by the sponsors.). But see McGarity & Shapiro, supra note 97, at 887 (arguing that trade secret status should not extend to much of the health and safety testing information); see also Lyndon, supra note 67, at 22-35 (outlining the prominence of trade secrecy claims under major regulatory statutes and observing that because [f]or a worker or neighbor seeking data from a company, trade secret information is, as a practical matter, simply unavailable the employer lacks any incentive to disclose such information) (citations omitted).

117 But see EPA Human Testing; Advance Notice of Proposed Rulemaking, 68 Fed. Reg. 24,410, 24,413 (May 7, 2003) (In general, EPA cannot readily determine whether such policies are consistent with or as protective of human subjects as the Common Rule, nor the extent to which such policies or standards have been followed in the conduct of any particular study. Thus, even wellconducted third-party human studies may raise difficult questions for the Agency when it seeks to determine their acceptability for consideration.).

118 Id.

119 Scientific Misconduct Regulations, 40 C.F.R. pt. 50, subpt. A; see generally Robert, M. Anderson, The Federal Government's Role in Regulating Misconduct in Scientific and Technological Research, 3 J. L. & TECH. 121 (1988)Google Scholar.

120 Herbert Needleman (whose research on child lead poisoning was pivotal in EPA's lead phase-out of gasoline) was alleged to have engaged in misconduct. The accusations of misconduct, brought by scientists who consulted with the lead industry, turned out to be meritless, and he was cleared of wrongdoing. See, e.g., Herbert L. Needleman, Salem Comes to the National Institute of Health: Notes from Inside the Crucible of Scientific Integrity, 90 PEDIATRICS 977 (1992); Joseph, Palca, Lead Researcher Confronts Accusers in Public Hearing, 256 SCIENCE 437 (1992)Google Scholar; Gary Putka, Professor's Data on Lead Levels Cleared by Panel, WALL ST. J., May 27, 1992, at B5. Scientific misconduct allegations were also brought against researchers documenting how the Joe Camel logo appealed to young adolescents. The charges were brought by an academic affiliated with RJR Reynolds, the holder of the Joe Camel trademark. Paul M. Fischer, Science and Subpoenas: When Do the Courts Become Instruments of Manipulation?, 59 LAW & CONTEMP. PROBS. 159, 160 (1996).

121 Some statutes like FIFRA even mandate rigorous peer review and scientific oversight for federal (but not private) research. See, e.g., 7 U.S.C. 136w(d)-(e) (2000) (requiring the scientific advisory panel established under the FIFRA to review the scientific basis for major regulatory proposals concerning pesticides and to adopt peer review procedures for scientific studies carried out by the government or under federal contract pursuant to FIFRA). Some of this elaborate peer review is mandated by Congress, and some is internally mandated. See NATIONAL ACADEMIES PRESS, STRENGTHENING SCIENCE AT THE U.S. ENVIRONMENTAL PROTECTION AGENCY: RESEARCH MANAGEMENT AND PEER REVIEW PRACTICES 102 (2000), available at http://books.nap.edu/books/0309071275/htmlpagetop (listing the statutes that require peer review of various scientific and technical practices, policies, and activities of the agency); EPA, SCIENCE POLICY COUNCIL, PEER REVIEW HANDBOOK xi-xii (2d ed. 2000), available at http://www.epa.gov/osp/spc/2peerrev.htm [hereinafter PEER REVIEW HANDBOOK].

122 See, e.g., NAS DATA QUALITY TRANSCRIPT, supra note 114, at 102-08, 144-46 (describing past and current weaknesses in EPA's peer review policies).

123 See generally PEER REVIEW HANDBOOK, supra note 121.

124 See, e.g., NAS DATA QUALITY TRANSCRIPT, supra note 114, at 105 (discussing the various federally supported research that should be peer reviewed, with lists that are often several lines long; but making no mention of industry-sponsored research used for regulation).

125 See generally PEER REVIEW HANDBOOK, supra note 121.

126 The Common Rule, 45 C.F.R. pt. 46 (2003).

127 See id.

128 45 C.F.R. 46.101; see THE NATIONAL COMMISSION FOR THE PROTECTION OF HUMAN SUBJECTS OF BIOMEDICAL AND BEHAVIORAL RESEARCH, THE BELMONT REPORT ETHICAL PRINCIPLES AND GUIDELINES FOR THE PROTECTION OF HUMAN SUBJECTS OF RESEARCH n.1 (1978) (discussing Nuremberg Code of 1947 and Helsinki Declaration of 1964 that are dedicated to protecting human subjects in research settings).

129 See, e.g., Press Release, EPA, Agency Requests National Academy of Sciences Input on Consideration of Certain Human Toxicity Studies; Announces Interim Policy (Dec. 14, 2001), available at http://www.epa.gov/epahome/headline2_121401.htm (postponing consideration of private human subjects research pending a National Academy of Sciences review of the complex scientific and ethical issues posed by EPA's possible use of third-party studies which intentionally dose human subjects with toxicants to identify or quantify their effects).

130 See Letter from Jim J. Tozzi, Center for Regulatory Effectiveness Board of Advisors, to Stephen L. Johnson, Assistant Administrator (May 10, 2002), EPA, available at http://thecre.com/pdf/20020510_cre-epa-letter.pdf.

131 See id.

132 See, e.g., Catherine, D. DeAngelis et al., Reporting Financial Conflicts of Interest and Relationships Between Investigators and Research Sponsors, 286 JAMA 89 (2001)Google Scholar; Jeffrey, M. Drazen & Gregory, D. Curfman, Financial Associations of Authors, 346 NEW ENG. J. MED. 1901 (2002)Google Scholar.

133 Cf. Jennifer, A. Henderson & John, J. Smith, Financial Conflict of Interest in Medical Research: Overview and Analysis of Federal and State Controls, 57 FOOD & DRUG L.J. 445, 455 (2002)Google Scholar (noticing in the area of biomedical research that both federal and state controls provide a relative lack of prospective guidance as to what constitutes acceptable institutional conflict policy.).

134 See, e.g., 7 U.S.C. 136a(c)(1)(F) (2000) (outlining test reporting required for registration of pesticides under FIFRA); 15 U.S.C. 2603 (2000) (outlining test reporting required for registration of stubstances of substances under TSCA).

135 Financial Disclosure by Clinical Investigators, 21 C.F.R. 54 (2003).

136 See id. (making no distinction between sponsor-controlled research and research where the sponsor relinquishes control).

137 See generally Arnold, W. Reitze Jr. & Lee, D. Hoffman, Self-Reporting and Self-Monitoring Requirements Under Environmental Laws, 1 ENVTL. LAWYER 681, 681, 739-41 (1995)Google Scholar (discussing civil and criminal penalties for violating reporting requirements, including criminal enforcement of false reporting and fraud).

138 See FIFRA, 7 U.S.C. 136d(a)(2) (2000) (If at any time after the re-registration of a pesticide the registrant has additional factual information regarding unreasonable adverse effects on the environment of the pesticide, the registrant shall submit such information to the regulator.); TSCA, 15 U.S.C. 2607(c), (e) (2000) (stating that manufacturers and processors must maintain records of significant adverse reactions to health or the environment alleged to have been caused by the substance or mixture [and must immediately report] information which reasonably supports the conclusion that such substances or mixture presents a substantial risk of injury to health or the environment).

139 See generally 40 C.F.R. pt 159 (2003) (outlining reporting requirements for risk/benefit information); EPA, Reporting Requirements For Risk/Benefit Information, 62 Fed. Reg. 49,370 (Sept. 19, 1997) (codified at 40 C.F.R. pt. 159).

140 40 C.F.R. 159.158(a) (2003).

141 Id. 159.167.

142 See id. 159.184.

143 See, e.g., 62 Fed. Reg. at 49,372 (Registrants are free to submit information challenging the validity of section 6(a)(2) information either at the time of, or after submission of the information to the Agency.).

144 For example, in its 2003 guidance, EPA created a number of new exemptions and lengthened the reporting time from fifteen working days to thirty calendar days. See TSCA Section 8(e); Notification of Substantial Risk; Policy Clarification and Reporting Guidance, 68 Fed. Reg. 33,129, 33,130 (June 3, 2003).

145 See, e.g., id. (Although these preferences could be codified in procedural rules , EPA is not at this time adopting them as rules. While submitters of section 8(e) notices are not therefore obligated to comply with the preferences articulated in this document, EPA encourages submitters to consider and follow them .).

146 See, e.g., id. at 33,138 (stating what the EPA considers substantial risks).

147 Id.

148 Substantial risks to ecosystems, for example, occur in relatively rare and worrisome settings. The EPA, for example, identifies substantial risks in non-emergency situations where there are [e]cologically significant changes in species interrelationships; that is, changes in population behavior, growth, survival, etc. that in turn affect other species behavior, growth, or survival. Id. at 33,138.

149 At most, EPA warns on its section 8(e) fact sheet that [l]imited studies (e.g., range finding studies), preliminary results and draft reports may constitute sufficient evidence for Section 8(e) reporting. EPA, TSCA SECTION 8(E) FACT SHEET, at http://www.epa.gov/opptintr/tsca8e/doc/facts8e.htm (last updated Apr. 12, 2004) (emphasis added). EPA also warns that the manufacturer need not wait for corroborating evidence, but implies that not reporting if a manufacturer believes the information is low quality is a valid basis for withholding reports. TSCA Section 8(e); Notification of Substantial Risk; Policy Clarification and Reporting Guidance, 68 Fed. Reg. at 33,138-39.

150 Id. at 33,139-40.

151 Information on EPA's enforcement resources under FIFRA was not readily available; in terms of the number of inspections conducted by EPA regional offices, this statute fared the worst, accounting for only one percent of all inspections conducted in 1998 (a decline from roughly 3% in 1995). ARNOLD W. REITZE, JR., AIR POLLUTION CONTROL LAW: COMPLIANCE & ENFORCEMENT 491 (2001). Some dated information on the staffing and resources of EPA's TSCA program, which primarily involves the review of pre-manufacture notifications under TSCA, suggests that the program is badly understaffed. A Bureau of National Affairs article reports that from 1990 to 1994 EPA experienced a 33% drop in staff and a 60% drop in funding dedicated to the review of new chemicals. See Testing: Screening Studies for Evaluating Chemicals on TSCA Inventory Suggested at OTA Workshop, 19 CHEM. REG. REP (BNA) 105 (1997). An Office of Technology Assessment project commenced in the mid-1990s found that in the nineteen-year history of TSCA implementation, EPA had reviewed only about two percent of the 70,000 chemicals in commerce. Id.

152 See 7 U.S.C. 136v (2000); 15 U.S.C. 2627 (2000) (stating that the EPA's authority under FIFRA is not delegated to the states).

153 See EPA, TSCA 8(e) REPORTING GUIDE JUNE 1991, at http://www.epa.gov/opptintr/tsca8e/doc/rguide.htm (last updated May 13, 2004).

154 See, e.g., Reporting Requirements for Risk/Benefit Information, 62 Fed. Reg. 49,370, 49,372 (Sept. 19, 1997) (to be codified at 40 C.F.R. pt. 159) (noting that violations of the FIFRA reporting requirements could result in actions for civil and/or criminal penalties under FIFRA section 14); TSCA Section 8(e): Notification of Substantial Risk, Policy Clarification and Reporting Guidance, 68 Fed. Reg. 33,129, 33,140 (June 3, 2003) (noting that violations of the TSCA reporting requirement can lead to civil and possible criminal liability).

155 Reporting Requirements for Risk/Benefit Information, 62 Fed. Reg. 49,370, 49,372 (Sept. 19, 1997) (to be codified at 40 C.F.R. pt. 159) (EPA does not intend to pursue cancellation every time section 6(a)(2) may have been violated, but egregious or repeated violations may warrant cancellation rather than, or in addition to, monetary fines.).

156 See, e.g., Steven Shavell, The Optimal Structure of Law Enforcement, 36 J.L. & ECON. 255, 261-62 (1993) (observing that firms will find it financially imprudent to comply with legal requirements when the benefits of noncompliance outweigh the probability of being caught multiplied by the penalty for the violation).

157 15 U.S.C. 2607e (2000) (requiring reporting to the EPA of substances that present a substantial risk of health or injury of the environment); see, e.g., EPA, TSCA8(E) AND FYI SUBMISSIONS RECEIVED FROM 10/21/03 TO 10/31/03, at http://www.epa.gov/opptintr/tsca8e/doc/8esub/2003/8e1020_103103.htm (last updated Apr. 23, 2004) (providing a recent sample of EPA section 8(e) submissions where the majority of section 8(e) submissions report results from formal toxicity studies).

158 It appears that nearly all of the substantial risk and for your information (FYI) submissions are designed toxicity studies. See, e.g., EPA, PREVIOUS TSCA 8(E) AND FOR YOUR INFORMATION (FYI) SUBMISSIONS LIST, at http://www.epa.gov/opptintr/tsca8e/doc/previous8(e).htm (last updated July 14, 2003).

159 Press Release, EPA, TSCA Enforcement Action Secures New Chemical Risk Data (Apr. 25, 1997), at http://yosemite.epa.gov/opa/admpress.nsf.

160 See Agency Watch, EPA's Voluntary Data; FAA Curbs the Bar, NATL L.J., Nov. 4, 1996, at A10.

161 See, e.g., HAMPSHIRE STUDY, supra note 61, at 10 (describing FYI filings and the dramatic increase in section 8(e) filings after EPA announced a reporting incentives program).

162 See, e.g., EPA, TSCA 8(E) AND FYI SUBMISSIONS RECEIVED FROM 01/02/03 TO 01/15/03, at http://www.epa.gov/opptintr/tsca8e/doc/8esub/2003/8e0102_011503.htm (last updated Apr. 23, 2004) [hereinafter 01/02/03 TO 01/15/03 FYI SUBMISSIONS].

163 See EPA, SUPPORT INFORMATION FOR CONFIDENTIALITY CLAIMS, at http://www.epa.gov/opptintr/tsca8e/doc/cbi.htm (last updated Apr. 12, 2004).

164 See HAMPSHIRE STUDY, supra note 61.

165 See, e.g., CAROLYN A. NUNLEY, RISK ON RECORD: AN OVERVIEW OF TSCA's SUBSTANTIAL RISK REPORTING SYSTEM WITH BULLETINS ON SELECTED CHEMICALS (1996), available at http://informinc.org/xsum_risks.php (providing summary of work).

166 Figure 1 was prepared using EPA's section 8(e) database. See 01/02/03 TO 01/15/03 FYI SUBMISSIONS, supra note 162. For each submission that included at least one CBI claim, the chemical that was the basis for the submission is identified as a CBI chemical. The larger column provides the total number of non-redundant 8(e) submissions for each year (note that two of the years are incomplete). For access to the underlying worksheets used to prepare this figure, please contact Wendy Wagner at [email protected].

167 These reform proposals are also advanced in Wagner, supra note 16, to combat the overlapping problem of inadequate environmental and public health research that results, in part, from regulated parties superior information over the effects of their products and activities.

168 See, e.g., ENERGY INFORMATION ADMINISTRATION, DEPARTMENT OF ENERGY, ENERGY INFORMATION STANDARD 2002-28 (recommending the information that should be available to maximize the third-party review of proprietary models).

169 See HAMPSHIRE STUDY, supra note 61.

170 As discussed, moreover, a significant portion of industry-sponsored research used in these regulatory efforts is protected from external scientific review through trade secret and confidential business privileges. See supra Part III.A. In fact, even in spite of its promise of requiring agencies to use and publicize only quality, objective science, the Data Quality Act requirements omit any disclosure requirements for conflicts of interest. By ignoring these disclosure requirements, the Data Quality Act seems to provide the public with misleadingly incomplete information for evaluating the integrity of research used for regulatory decisions. See Consolidated Appropriations (Information (or Data) Quality) Act, 515, Pub. L. No. 106-554, 114 Stat. 2763 (2000).

171 See supra Part III.C.

172 See, e.g., INTERNATIONAL COMMITTEE OF MEDICAL JOURNAL EDITORS, UNIFORM REQUIREMENTS FOR MANUSCRIPTS SUBMITTED TO BIOMEDICAL JOURNALS, at http://www.icmje.org (last updated Nov. 2003).

173 See, e.g., Sheldon, Krimsky & L.S., Rothenberg, Conflict of Interest Policies in Science and Medical Journals: Editorial Practices and Author Disclosures, 7 SCI. & ENGINEERING ETHICS 205, 217-18 (2001)Google Scholar (listing survey).

174 The form of conflict disclosures used by biomedical journals has grown more sophisticated over the years, and the editors of a group of the world's leading biomedical journals recently declared that they will no longer publish articles based on studies done under contracts in which the investigators did not have the unfettered right to publish the findings. In a joint statement the editors of thirteen journals asserted that contractual arrangements that allow sponsor-control of publication not only erode the fabric of intellectual inquiry that has fostered so much high-quality clinical research but also make medical journals party to potential misrepresentation, since the published manuscript may not reveal the extent to which the authors were powerless to control the conduct of a study that bears their names. Frank, Davidoff et al., Sponsorship, Authorship and Accountability, 286 JAMA 1232, 1233 (2001)Google Scholar.

175 With the increased involvement of universities in commercial enterprises and collaborations, many academic institutions have developed policies or guidelines that attempt to ensure this independence. The guidelines of the University of California, for example, assert that research is a component and outcome of an academic environment characterized by the free and open exchange of ideas. UNIVERSITY OF CALIFORNIA OFFICE OF THE PRESIDENT, GUIDELINES ON UNIVERSITY-INDUSTRY RELATIONS, available at http://www.ucop.edu/ott/unindrel.html (May 17, 1989) ([F]reedom to publish is fundamental to the University and is a major criterion of the appropriateness of a research project.). Universities see the need to protect the independence of their research with formal policy. The Johns Hopkins University School of Public Health, for example, requires that faculty members who enter into contractual agreements for sponsored research retain full rights to publish and otherwise disclose information developed in the research. JOHNS HOPKINS SCHOOL OF PUBLIC HEALTH, OFFICE OF RESEARCH ADMINISTRATION, INTELLECTUAL PROPERTY POLICY, at http://www.jhsph.edu/ora/IPG/nspolicy.htmC.%20Publication (Oct. 27, 1992).

The Center for Science in the Public Interest advocates for the voluntary disclosure of funding sources. See CENTER FOR SCIENCE IN THE PUBLIC INTEREST, INTEGRITY IN SCIENCE, at http://www.cspinet.org/integrity (last visited July 14, 2004).

176 David, Michaels & Wendy, Wagner, Disclosure in Regulatory Science, 302 SCIENCE 2073 (2003)Google Scholar. An industry organization, the American Chemistry Council (ACC), concedes that such disclosures are a positive step, Carol, J. Henry et al., Letter, Questions About Disclosures, 304 SCIENCE 1447 (2004)Google Scholar, while disputing that there are bias and suppression problems with most industry-sponsored research. ACC's specific disagreements are refuted in detail at Part III, supra.

177 See, e.g., AMERICAN MEDICAL ASSOCIATION, AUTHORSHIP CRITERIA AND RESPONSIBILITY, FINANCIAL DISCLOSURE, COPYRIGHT TRANSFER, AND ACKNOWLEDGMENT FORM, available at http://jama.ama-assn.org/cgi/data/290/1/125/DC1/1 (last visited July 20, 2004).

178 Currently, since these positive attributes of researcher independence cannot be advertised or validated, actors cannot gain reputational advantages or esteem norms from relinquishing control over research studies. Cf. George, Akerloff, The Market for Lemons: Qualitative Uncertainty and the Market Mechanism, 84 Q. J. ECON. 488 (1970)Google Scholar (observing in general that establishing a strong reputation is one of the primary means to avoid the downward forces of adverse selection); Richard, H. McAdams, The Origin, Development, and Regulation of Norms, 96 MICH. L. REV. 338, 369-72 (1992)Google Scholar (arguing that norms work only when others can observe the good behavior).

179 See, e.g., Cornelia Dean, Editing Science, Address at the Center for Science in the Public Interest Conference on Conflicted Science (July 11, 2003) (discussing the challenges to journalists reporting the status of research accurately and learning and reporting the financial ties of those [scientists] who make the news). With such a reform in place, EPA could post all research conducted on any given chemical or environmental issue, along with the objectivity status of each of the studies, based on the extent of sponsor control over the research. See, e.g., EPA, INTEGRATED RISK INFORMATION SYSTEM, at http://www.epa.gov/iris/ (last updated July 9, 2004) (providing risk estimates on a chemical by chemical basis, with a reference list at the end of each chemical-specific report that currently does not, but could provide information about the independence of each study). This would provide valuable information for scientists, regulators, and the public. If, for example, the only positive studies on a new pesticide registration application were conducted by the pesticide manufacturers or users, this information would help in weighing all of the information, particularly if the adverse studies were produced by parties that were free of sponsor control.

180 For example, under the Clean Water Act and Comprehensive Environmental Response, Compensation, and Liability Act, reporting requirements could be revised to require the reporting of any non-de-minimis releases. Legal authority exists for EPA to make this change because Congress clearly delegates the decision about setting reportable quantities or threshold levels to the EPA. See Clean Water Act, 33 U.S.C. 1321(b)(4) (2000); CERCLA, 42 U.S.C. 9602(b) (2000).

181 See EPA Reporting Requirements for Risk/Benefit Information, 62 Fed. Reg. 49,388 (Sept. 19, 1997) (originally defining registrant to include any employee or agent of such a person; provided that any employee or agent who is not expected to perform any activities related to the development, testing, sale or registration of a pesticide, and who could not reasonably be expected to come into possession of information that is otherwise reportable under this part, shall not be considered a registrant for purposes of this part; and provided further that information possessed by an agent shall only be considered to be possessed by a registrant if the agent acquired such information while acting for the registrant).

182 See Reporting Requirement for Risk/Benefit Information; Amendment and Correction, 62 Fed. Reg. 49,388 (Sept. 19, 1997) (codified at 40 C.F.R. pt. 159) (omitting agents from definition of registrants).

183 TSCA appears to already have broadened the scope of responsible parties for reporting. Under TSCA, any person who has possession of a study is among those required to report relevant health and safety studies on a toxic substance to the EPA. 15 U.S.C. 2607(d) (2000). A clearer definition of what constitutes a study and the reporting requirements could impose substantially greater demands on both researchers and sponsors.

184 See, e.g., EPA OFFICE OF POLLUTION PREVENTION AND TOXICS, FINAL ACTION PLAN: TSCA CONFIDENTIAL BUSINESS INFORMATION REFORM (June 20, 1994); HAMPSHIRE STUDY, supra note 61, at 41 (concluding based on review of CBI claims from 1977 through 1990 that all available evidence supports the proposition that much of the information covered by CBI claims is not legitimately entitled to protection as TSCA CBI.); TOXIC SUBSTANCES CONTROL ACT, supra note 68; ENVIRONMENTAL INFORMATION, supra note 100.

185 In the report, for example, GAO notes that competitive intelligence professionals and industry representatives disagreed on the value of environmental reporting to secure competitors secrets. Industry representatives stated that the information often contains valuable details about their competitors while other competitive intelligence professionals said that such information is neither sufficient or even necessary. ENVIRONMENTAL INFORMATION, supra note 100, at 15. GAO went on to note that [r]egardless of their views on the usefulness of this information, industry officials acknowledged that they could do a better job in protecting their sensitive business information while still complying with EPA's and states reporting requirements. Id.

In the report the GAO also provided other information that suggests industry might be inflating its claims that broad CBI protection in environmental regulation is needed to preserve their trade secrets. Id. First, GAO noted that in the two states that employ materials accounting, fewer than two percent of the facilities made confidentiality claims in 1996 [or thereafter] even though both states (New Jersey and Massachusetts) have permissive CBI procedures. Id. at 18.

Industry itself seems to acknowledge the lack of competitor interest in the information, touting the infrequency of FOIA claims. See, e.g., Letter from Warren E. Stickle & Bill Balek to EPA, supra note 67 (arguing that the many thousands of products on the market few have or ever will be subject to a FOIA request and that the up-front substantiation requirement would be a waste of registrants resources as well as harmful for the chemical manufacturers).

186 See, e.g., OReilly, supra note 66, at 10203 (discussing the obsolescence of industry's fixation on the physical security of regulatory submissions containing their chemical data in the wake of the information age).

187 See, e.g., Lyndon, supra note 67, at 50-55 (proposing multiple alternatives to trade secrets with varying levels of protection of an industry's competitive advantages); McGarity & Shapiro, supra note 97, at 882-87 (recommending exclusive-use periods for health and safety data that has trade-secret value, but requiring full disclosure); OReilly, supra note 66, at 10208-211 (proposing a narrower trade-secret protection for protecting information and more effective mechanisms for sharing information with the public); see also TOXIC SUBSTANCES CONTROL ACT, supra note 68, at 5:6 (suggesting specific TSCA legislative changes to reduce the problem of overbroad CBI protections).

188 See, e.g., Mcgarity & Shapiro, supra note 97, at 880-81 (stating that although FIFRA does not suggest a cost apportioning method, TSCA directs the Administrator to consider various factors).

189 Under FIFRA, subsequent manufacturers that benefit from data submitted previously by another manufacturer must compensate that manufacturer for part of the development costs if their application occurs within ten (plus) years after the original data production. See 7 U.S.C. 136a(c)(1)(F) (2000) (providing original applicant a right to exclusive data use for registration of pesticides after 1978). The constitutionality of this provision has been upheld by the Supreme Court, including the use of binding arbitration to determine the amount of compensation. See Thomas v. Union Carbide, 473 U.S. 568 (1985); Ruckelshaus v. Monsanto, 467 U.S. 986 (1984). Under the right circumstances, manufacturers may be able to copyright their studies. See, e.g., 17 U.S.C. 102(a) (2000) (providing non-exclusive list of works meriting copyright protections, thereby allowing the copyright of studies in limited circumstances). But since the results of the study can be used by a regulator without having to pay copyright royalties (assuming that the manufacturer shares the study with an agency), then other manufacturers are still able to free-ride on the regulatory benefits of the information.

190 The statutory time frame under FIFRA is ten years, which might not provide adequate time to ensure fair reimbursement for the originators of health and safety research. 7 U.S.C. 136a(c)(1)(F) (2000).

191 See, e.g., Lyndon, supra note 67, at 54 (discussing use of environmental patents to provide firms with mechanisms for seeking compensation for disclosure of competitively valuable information); McGarity & Shapiro, supra note 97, at 882-87 (recommending full disclosure, but allowing firms to claim exclusive use).

192 EPA underscores this in its 2000 effort at CBI reform. 65 Fed. Reg. 80,394, 80,395 (Dec. 21, 2000) (discussing proposal for up-front substantiation of CBI claims and stating that [w]e believe this would help reduce the number of overly-broad or non-specific claims); see also HAMPSHIRE STUDY, supra note 61, at 39-40 (recommending up-front substantiation and also sunset periods on CBI claims).

193 See, e.g., HAMPSHIRE STUDY, supra note 61 at 39-40.

194 See, e.g., id. at 26, 40 (discussing the direct and indirect out-of-pocket costs of CBI claims and recommending a filing fee for each CBI claim).

195 See also id. at 38-39.

196 42 U.S.C. 11042(c) (2000) (prescribing regulations equivalent to comparable provisions in the Occupational Safety and Health Administration Hazard Communication Standard).

197 See also HAMPSHIRE STUDY, supra note 61, at 39 (recommending report cards indicating for each submitter the number of submissions, the number of CBI claims, and perhaps the number of challenges issued on these claims).

198 An alternative approach would be the certification of private laboratories, with periodic quality audits, to ensure greater research independence from manufacturer and researcher. Cf. Shapiro & Charrow, supra note 18, at 2510 (suggesting similar certification requirements to reduce conflicts occurring in FDA required biomedical research).