This article is one in a series. For the other articles, please see: INDEX: “Why You Can’t Trust Government Science”
Most of the studies that the federal government uses to determine the safety of chemicals is conducted by corporations or their contractors. That work is done by people with financial conflicts of interest and without proper scientific safeguards and oversight. See Why You Can’t Trust Corporate & Federal Regulatory “Science” for more details.
One of the biggest scandals of federal regulatory science is that most of it is kept secret. Lax laws and regulations allow corporations to summarily classify their studies and regulatory submissions as “Confidential Business Information (CBI) — also known as trade secrets. Significantly, federal regulators have no say in the matter because corporations alone decide what information is a trade secret.
Classifying information as a trade secret completely eliminates any transparency. Further, secrecy prevents any oversight and encourages corporations to continue creating shoddy science. According to a pivotal study of the practice, Equal Treatment for Regulatory Science:
[D]espite the higher probability of bias in private research relative to public research, most “sound science” laws and regulations focus peer review, external complaint processes, and other quality controls almost exclusively on public research or syntheses of research findings.
Private research is also exempted from public scrutiny through guarantees afforded “proprietary information” and “confidential business information” (“CBI”).
Chemicals So Secret You Dare Not Utter Their Name
Some religions have gods so powerful that to utter their very name dooms the speaker.
Chemical companies are like that as well. In many cases, their trade secrecy demand is so outrageous that even the identity of a chemical is classified as a CBI secret.
And while the EPA has been reviewing secret chemicals, its most recent report on the process, February 20, 2013, indicates that it has maintained secrecy on more than four-times as many substances as it has declassified: “783 declassified cases, 3,242 CBI claims allowed.”
This allows dangerous chemicals which have been approved by sloppy and often devious corporate studies to be secretly hidden in products that you use.
Bury The Bad Stuff
Secret science by corporate and private labs makes it easy for corporations to bury toxic products. Sanitized as “adverse effects,” the damaging and fatal effects resulting from corporate concealment are nearly too numerous to list.
The many instances of this ability of regulatory, corporate and private science to conceal the dangers include:
- Most hormone disruptors including BPA, phthalates, flame retardants and pesticides,
- The surgical probe responsible for spreading the UCLA superbug deaths,
- Tobacco
- Asbestos,(footnote, this article)
- Diethylstilbestrol (DES),
- Silicone breast implants (footnote, this article)
- The Dalkon Shield IUD (also footnote, this article)
- Pharmaceuticals: Secret Clinical Trial Data to Go Public
See FDA Failures for more information and many more examples. (Note, that article is currently a draft/stub article currently being edited)
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No Meaningful Penalty For Hiding Adverse Effects
While companies are supposed to report adverse effects, there is little incentive for them to comply because penalties are so minor and the chances of being caught are almost nil. According to Equal Treatment for Regulatory Science:
“In comparing the costs of the penalties (and the low probability of being caught in violation of the regulations) against the economic benefits of withholding adverse information, rational companies may find it in their interest to violate the adverse reporting requirements when the chance of detection is especially low.
“Armed with ambiguous and narrow criteria for reporting under TSCA (Toxic Substances Control Act), coupled with low sanctions and a low probability of enforcement, one would expect rational manufacturers and other covered parties to report adverse discoveries only when the records of these adverse effects are likely to be discovered.”
Over Compliance: Another Way To Dodge Sanctions
Corporations have the deep pockets to thwart federal enforcement efforts in other ways.
In the early 2000s, when the always-understaffed EPA threatened to go after those who did not report adverse effects, the private sector simply buried them with irrelevant information.
“In response, the companies volunteered 11,000 studies of their products—four times the number of studies submitted in the prior fifteen years since passage of the statute!” wrote Equal Treatment for Regulatory Science:
“Finally, it appears that industry has developed a compliance strategy under TSCA that routinely involves sending toxicity research to the EPA even when the outcome is inconclusive or not suggestive of a “substantial risk.” These are called “for your information” (“FYI”) submissions.
“This might also be a rational compliance strategy for industry because they can avoid damaging admissions of “substantial risk” by labeling all reports as FYI.
“[I]t is not clear how useable the information that is reported under these adverse reporting requirements is, or whether it is even intended to be useable when the manufacturer or other party reports it.”
Adverse Reports: Secret & Incomplete
According to Equal Treatment for Regulatory Science:
“The [adverse effects] data is sometimes protected as confidential business information. Even when the adverse effects reports are accessible and publicly available, they appear to be incomplete.
Secret Science: No Way To Validate Legitimacy
Equal Treatment for Regulatory Science continues:
“A great deal of private science is classified and reviewed by only a few, cleared government officials, despite the fact that open communication of research is a tenet of good science.
“Current regulatory programs provide regulated parties with the option of classifying any information that they believe could be used by a competitor to their economic detriment
“As a result, manufacturers and polluters have been given wide latitude … to classify health and safety research that they believe can cause economic harm as confidential business information, often without specifying the nature of the trade secret concerns.
“Once the CBI claim is asserted by a regulated party, the claim of “trade secret” is generally considered valid by the EPA until a party requests the information under the Freedom of Information Act (“FOIA”).
“Health and safety studies (as well as most routine claims on the corresponding chemical identity of a toxic substance) are among the information classified by industry as CBI, even though the laws expressly disfavor this classification.
“Under most existing regulations, moreover, the CBI claims require no substantiation—a manufacturer has only to stamp the documents “confidential” for the privilege to apply.
“No official from the company need take responsibility for asserting the claim; there are no penalties for asserting the claim when it is facially frivolous; and the firm is presumed to waive the privilege if they do not stamp this information as confidential when first submitting it to the agency.
“Based on this regulatory structure, firms openly concede that it is more cost-effective for them to routinely stamp as much internal information as CBI when no substantiation is required.”
Huge Barriers To Access Secret Science
From Equal Treatment for Regulatory Science:
“A 1992 Hampshire Study reported that federal and state agencies encountered significant barriers accessing CBI information, while labor and environmental groups said they had “given up” on seeking CBI information submitted under TSCA.
“For example, in the review of biotechnology products, environmental groups reported that it took three years to acquire the CBI stamped information under FOIA; by that time, the industry’s request for a license had been approved and “in many cases the environmental release of genetically engineered organisms had occurred.”
“The Hampshire study also noted the lack of public participation on EPA’s efforts to ban asbestos, a fact that it attributed in part to the fact that a significant portion of the information on the safety of asbestos, and the agency’s analysis of that information, has been classified by the regulated industry as CBI.
“Despite the potentially significant social costs in terms of reduced scientific and public oversight of private research, the EPA has few incentives to conduct more aggressive review of CBI claims.
“The high direct cost of reviewing all stamped information provides the first major impediment. As a result of these costs, agency officials concede that they typically do not review the merits of industry CBI claims, at least for new chemical classifications. Instead these claims are automatically retained.”
Regulators Face Severe Penalties For Secret Data Mistakes
While companies face trivial sanctions for falsly claiming something as a trade secret, regulators who make a mistake handling CBI face severe penalties. According to Equal Treatment for Regulatory Science:
[F]rom the agency official’s perspective, there are more costs than benefits to disputing CBI claims.
“Agency officials who wrongfully divulge trade secret information can be charged criminally, imprisoned for up to one year, and must be terminated from their position. The agency also could be subjected to a “reverse FOIA” suit, and potentially even a suit claiming compensation for the wrongful misappropriation.
“By contrast, the only penalty for making an erroneous judgment not to disclose CBI is the possibility of a suit by the person seeking the information under FOIA.”
Footnotes From Equal Treatment for Regulatory Science:
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”).
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.
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.
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 workmen’s-compensation claims and lawsuits,”
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