Monday, October 18, 2004

The Shelby Amendment: the boogey man never came

Back in 1999, the Shelby amendment was controversial. Many scientists and scientific societies predicted doom and gloom. Five years later in 2004, we see that these predictions were way off the mark and probably represented interest-group mindset rather than objective reasoning.

In 1999, Dick Kirschten reported on Rush Holt's position opposing the amendment:

-->Rep. Rush Holt, D-N.J., a physicist, describes the Shelby amendment as an attempt at "back door regulatory reform." He attributes it to a mind-set holding that "if those regulators are doing things to me that I don't like, then it must be bad science." Holt says all research findings should be open to scrutiny not only by the public but by other scientists who can try to replicate or refute them. But, he adds, "that doesn't mean the scientist should be harassed while doing the research." <--

In "Risk-Aversion and Iatrogenic Events: Not All Patent Claims (or Lawyers) Are Created Equal," (Intellectual Property Today, March 2000), I took issue with Holt's view of the Shelby amendment.


On January 10, 2000, Chemical & Engineering News (CEN) published a guest editorial by Congressman Rush Holt (D-NJ), who has a Ph.D. in physics and was formerly assistant director of Princeton University's Plasma Physics Laboratory. Entitled "Repealing a Bad Law," it was directed to the Shelby amendment of the
Freedom of Information Act (FOIA), although it did not refer to the "Shelby amendment" or Senator Richard Shelby by name. There was an aspect of the editorial pertinent to possible effects of the Shelby amendment on intellectual property (IP) rights created under the Bayh-Dole Act, although the Bayh-Dole Act was not named. This IP-relevant text follows.

As a direct result of this law, university-industry partnerships will be adversely affected because FOIA does not adequately protect scientists from proprietary breaches. Data from privately funded research may be conmingled with data from publicly funded research in ways that may be difficult to separate. This will dampen industry's enthusiasm for academic collaboration and significantly hinder scientific progress, particularly in fast-paced high-tech
industries. According to PhRMA [Pharmaceutical Research & Manufacturers of America], this amendment "could result in the release of commercially sensitive data and thereby undermine the incentives for joint public-private cooperative research." It is vital that this productive environment for research not be
hampered by the issues that will result from these new regulations. n12

n12 R. Holt, Chemical & Engineering News, p. 3 (Jan. 10, 2000). Holt presumably considers the Shelby amendment iatrogenic. Also, L. B. Ebert, C&E News, p. 4 (Jan. 31, 2000). Of the possible issue that disclosure under FOIA to third parties might lead to patents to third parties, one wonders if the public is poorly served if data derived from public grant funds create (additional)
inventions not contemplated by the grantee. The buckyball saga illustrates a related point, wherein it was the SECOND group of researchers to knowingly make C60 (the academic Professors Smalley, Kroto and Curl, who corrected the imperfect FIRST results of the industrial workers) who received the Nobel Prize.

On January 12, 2000, I emailed the following letter to CEN.

Of the guest editorial "Repealing A Bad Law" (C&EN, 10-Jan-00),
Congressman/scientist Holt is somewhat lawyer-like in omitting certain details surrounding the Shelby amendment of Public Law 105-277, which gives the public access to data generated by federally-funded grants under procedures established under the Freedom of Information Act ("FOIA"). Cong. Holt says that the "legislation was introduced hastily in backroom discussions without any public
debate" and that "it was concocted in the dark of night," but fails to mention the factors which caused Senator Shelby to act. These omitted aspects include the following. The National Institutes of Health funded the Harvard School of Public Health to research certain clean air/particulate matter issues. The Environmental Protection Agency used these research findings in justifying
regulations pertaining to sources of small particle emissions ("soot"). The regulated community wanted to see the data. The request was denied. The data resided with Harvard and not the EPA, and were thus immune from a FOIA request. Senator Shelby acted to rectify the problem. In doing so, Senator/ lawyer Shelby was in harmony with a 1985 statement of the National Research Council:
"Scientists have a special responsibility to share data as quickly and as widely as possible where the data are or will become relevant to public policy." Cong. Holt identifies four major problems with the Shelby amendment: confidentiality breach, "infringement of intellectual property", opportunity for harassment and administrative burden. Of the intellectual property issue, 35 USC sections 200 -212 (relevant portions of the Bayh-Dole Act) and 37 CFR 401-414 (implementing rules thereof) impose confidentiality restrictions on the agencies as to release under FOIA. Of the non-profit organization itself, the fact that it is the first entity to generate and to possess the data suggests that it is in the best
position to file for patent protection, with or without the Shelby amendment, with or without conmingled data. The availability of provisional applications (35 USC section 111(b)) allows rapid and inexpensive filing to establish protection. Of harassment, would one prefer partisan lobbyists to make ad hominem attacks (the no-FOIA Holt world) or at least to address issues in the
underlying data (the FOIA Shelby world)? In the context of the Dorn controversy (Science, 29-Oct-99, pp. 883, 885), a lawyer was quoted: "Scientific disputes normally get worked out by a riproaring debate in the literature." The debates most useful to society are those with all available facts on the table. The concerns raised by Cong. Holt must be addressed, but omitting the issues of
Sen. Shelby is not a good way to reach dialog and resolution.

On January 20, CEN said my letter would be published. En route to
publication, the key sentence on the intellectual property issue underwent transmogrification. Thus, "Of the non-profit organization itself, the fact that it is the first entity to generate and to possess the data suggests that it is in the best position to file for patent protection, with or without the Shelby amendment, with or without conmingled data" was changed by CEN to become "Of the nonprofit organization itself, (as considered in the Bayh-Dole Act), since it is the first entity to generate and to possess the data, it is in the best position to file for patent protection, with or without the Shelby amendment or commingled data." I requested substitution of "as considered in the Bayh-Dole Act" by -- e.g., a university -- but CEN, without authorization, published the
key sentence as: "Since Harvard is the first entity to generate and possess the data, it is in the best position to file for patent protection -- with or without the Shelby amendment or conmingled data."

Instead of dealing with the nub of the general issue of the Shelby amendment (opening up grantees (e.g., universities) to FOIA) and the general sub-issue (the interplay of the Shelby amendment with the Bayh-Dole Act), CEN made it appear that the specific Harvard/ NIH/EPA episode concerned patent rights, which it did not.

In the debate about the Shelby amendment, there has been some discussion of the amendment effectively (or essentially) overturning a 1980 Supreme Court decision, Forsham v. Harris, 445 U.S. 169 (1980). This is incorrect. In Forsham, the court noted FOIA (5 USC 552) empowers federal courts to order an "agency" to produce "agency records improperly withheld." (Section 552(a) (4)(B)) but that the data at issue were not "agency records." Forsham, 445 US at
177. Post-Shelby, the data in Forsham still are not agency records. FOIA was amended to allow access to grantee's data. n13 However, comparisons of Forsham to Shelby are interesting. In Forsham, the technical data at issue pertained to the correct treatment regimen for diabetes, and the petitioners (whose ideas were adversely affected by a federal regulation) wanted to see the data and statistical methods. Because the data were not agency records, they didn't get to see the data. Justice Rehnquist (a "conservative") wrote the opinion effectively blocking data access and Justices Brennan and Marshall ("liberals") dissented. About twenty years later, Senator Shelby (a "conservative" and a lawyer) is blocked in his efforts to secure data on behalf of people adversely
affected by a federal regulation. n14 He presents his amendment, effectively opening data access, and Congressman Holt (a "liberal" and a scientist) tries to repeal the amendment and to cut back data access.

n13 For a discussion of the contractee/grantee dichotomy, see letter of Gary D. Bass of OMB Watch in the Washington Post, April 20, 1999.

n14 The regulation tightened standards on particulate emission. The author discloses that he worked as a scientist on soot. L. B. Ebert, J. C. Scanlon and C. A. Clausen "Combustion Tube Soot from a Diesel Fuel/Air Mixture: Issues in Structure and Reactivity," Energy & Fuels, 2, 438 (1988). The impact of the Shelby amendment on the collaboration between Exxon (analyzer of soot) and a
university grantee/ contractee (creator of soot) might be interesting to contemplate. Separately, the work showed that soot consists primarily of polynuclear aromatics (a class including potent carcinogens) rather than benevolent buckyballs, theoretically avoiding an iatrogenic outcome. [Note added in 2004: As is known in 2004, but not known in 2000 when the IPT article was written, buckyballs are toxic at 20 parts per billion, and are thus not benevolent. However, soot, in 2004, in 2000, and at all previous relevant times, has far, far more polynuclear aromatics than buckyballs specifically or fullerenes generally.]

[IPT available LEXIS: March 13, 2000; see also article in National Law Journal on Shelby amendment in 2000.]

**** Later study of the impact of the Shelby amendment did not confirm Holt's fears.

-->In the Spring 2001, the Science, Technology and Law Program of the National Research Council (NRC) held a workshop on the effect of the "Shelby" Amendment on public access to research data. Agencies representatives at that meeting indicated that they had received relatively few FOIA requests under the Shelby Amendment for scientific information (14 from NIH and 7 from EPA). <--

Similar findings were also reported by the Government Accounting Office (GAO) at . The GAO additionally noted:

-->Each of the eight federal agencies we examined relies on university scientists who receive federally funded research grants to make the results available to the public; five of these agencies also disseminate results by posting them on their Web sites. Although university scientists customarily seek to publish their research results in peer-reviewed journals, agencies cannot require such publication as a condition for funding because it is impossible to ensure in advance that the results will be deemed by peer review to be acceptable for publication. Agencies do, however, explicitly encourage funding recipients to make results available to the public, and they consider scientists' publication records in reviewing grant applications. Agriculture, Defense, Energy, EPA, and NASA also disseminate the results of the research they fund by posting researchers' final reports on their Web sites because, according to officials at these agencies, Web sites offer an effective way to share information among scientists, as well as with the public. In contrast, NIH officials told us that they do not post researchers' final reports because, in the biomedical field, the risks associated with posting results that have not been scrutinized and validated by peer review are too great. Similarly, NSF officials said that NSF does not post results, partly because some scientific journals reject manuscripts if the results have already been posted on the Web. Education currently is considering how best to respond to the directive in the Education Sciences Reform Act of 2002 to widely disseminate the findings and results of scientifically valid research in education. We are recommending that Education post the results of the research it has funded on its Web site to facilitate access to and maximize the benefits of its research investment. Education agreed with our recommendation.<--


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