Larry's Curb Your Anticipation, Part 1:Some General Questions

Up to the Introduction; On to part 2.

By Commenter Larry

Preliminary Questions

Why Are the WADA Rules Binding on International Cycling?

Let’s begin our discussion of anti-doping law at the most basic level. All professional cyclists are licensed by a national federation, such as USA Cycling in the U.S. The terms of a national cycling license require that the cyclist follow the anti-doping rules of the national federation, the Union Cycliste Internationale (UCI) and the World Anti-Doping Agency (WADA).

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For example, the terms of the International License available through USA Cycling include the following:

I shall submit to disciplinary measures taken against me and shall take any appeals and litigation before the authorities provided for in the regulations. I accept the Court of Arbitration for Sport (CAS) as the only competent jurisdiction of appeal in the cases provided for by the Regulations and in compliance with the terms thereof. ... I agree to submit to drug testing and to comply with and to be bound by the UCI anti-doping regulations, the World Anti-Doping Code and its International Standards to which the UCI anti-doping regulations refer as well as the anti-doping regulations of other competent instances as foreseen by the UCI Regulations, the World Anti-Doping Code, or the U.S. Anti-Doping Agency (USADA), provided such regulations comply with the World Anti-Doping Code. …. I accept these conditions regarding blood testing and agree to undergo all tests required of me.

See http://www.usacycling.org/forms/intl_license.pdf.

The primary authority in international cycling is the UCI. WADA’s authority in cycling derives from UCI’s adoption of the World Anti-Doping Code (the WADA Rules). The WADA Rules are incorporated in the UCI Cycling Regulations (UCI Rules). See UCI Rule Part 14, Introduction, at http://www.uci.ch/imgArchive/Rules/14ant-E.pdf.

Whenever possible, I will cite to both the WADA Rules and the UCI Rules in the following discussion.

A Brief Description of the WADA Rules and the UCI Rules

In an anti-doping case, the anti-doping organization (ADA) has the initial burden of establishing that an anti-doping rule violation has occurred. UCI Rules Article 16, WADA Rules Article 3.1. However, once the Anti-Doping Organization introduces evidence of an anti-doping violation from a WADA-accredited laboratory, the results are presumed correct. UCI Rules Article 18, WADA Rules Article 2.4.3. The athlete is then entitled to rebut this presumption by establishing that the lab departed from the ISL. UCI Rules Article 18, WADA Code Article 3.2.1. If the athlete is able to prove an ISL departure, then the ADA must prove that the departure did not cause the adverse analytical finding (AAF) against the athlete. Id.

The process described above sets up what we’ve called the “burden shift” or “burden flip”. The athlete has the initial burden to show an ISL departure, at which point the burden “flips” to the prosecuting ADA to show that the ISL departure did not cause the AAF. In this article, we’ll focus almost exclusively on the first part of the “flip”: we’ll be looking at what it takes to prove an ISL departure. But keep in mind that this discussion is only half of the story: the ADA may be able to meet its burden of proof even if the burden is “flipped”. Remember that in the FL case, the FL legal team was able to prove a number of departures from the ISL, but USADA was able to prove (to the satisfaction of two of the three arbitrators on the panel) that these departures did not cause the AAF against FL.

Let’s look closer at the standard of proof required to establish an AAF. Under the UCI and WADA Rules, the ADA must prove the AAF “to the comfortable satisfaction of the hearing body bearing in mind the seriousness of the allegation which is made.” According to the UCI Rules and the WADA rules, this standard of proof is greater than the mere balance of probability required to win a case in a U.S. civil court proceeding, but is less than the proof beyond a reasonable doubt required for a U.S. criminal conviction. See UCI Rules Article 16, WADA Rules Article 3.1. In the case of USADA v. Montgomery, http://www.usantidoping.org/files/active/arbitration_rulings/CAS%20Decision_Tim%20Montgomery_Dec%202005[1].pdf, the Court of Arbitration for Sport (CAS) defined "comfortable satisfaction" to impose an “extremely high” level of proof on the prosecuting ADA. In the Montgomery case, the CAS ruled that there was “little, if indeed any, difference” between the standard of proof imposed on the ADA and proof beyond a reasonable doubt. The FL legal team concluded that USADA’s burden of proof in the FL case was “very close to ‘proof beyond a reasonable doubt’", see http://ia351413.us.archive.org/1/items/Floyd_Landis_Case_Documents_14/RespondentsProposedFindingsofFact.pdf paragraph 2.4.7, and I think that this conclusion is correct.

Is An SOP Violation the Equivalent of an ISL Departure?

In our discussions on TBV, we’ve discussed instances where the lab in the FL case may have violated its own standard operating procedures (SOP) in conducting its testing. For example, we’ve discussed at length whether the lab’s machinery was set up in accordance with the lab’s SOP. See the discussion at http://trustbut.blogspot.com/2007/12/different-columns-detailed.html. If a lab violates its own SOP, is this treated under the WADA rules like an ISL departure, where the lab must prove that its SOP violation did not cause the AAF?

This issue came up in the FL case. The lab in the FL case, the LNDD, had a SOP requiring it to do a monthly check of the linearity of its Isotope Ratio Mass Spectrometer (IRMS). USADA admitted that LNDD did not make these monthly checks. The arbitrators ruled as a result that “the Lab failed to adhere to the ISL in failing to check the linearity of the IRMS instrument on a monthly basis as provided for in its ISO 17025 accreditation.” See FL decision paragraph 218 (emphasis added). Later in the decision, focusing on this same point, the arbitrators stated that “[t]he SOPs are part of the ISO 17025 accreditation”.

It’s clear from the FL decision that at least some SOP violations will be treated as ISL departures under the WADA Rules. The key appears to be whether the SOP is a part of the lab procedures that are reviewed in the ISO 17025 accreditation process. While this question is not clearly answered in the FL decision, I would argue that any violation of an SOP that can clearly be connected to a requirement under the ISL or ISO 17025 should be treated as an ISL departure. For example, the LNDD’s failure to do its monthly linearity check of its IRMS machine arguably violated ISO 17025 Rule 5.4.5.3, which requires the lab to assess linearity as part of its method validation, and ISO 17025 Rule 5.5, which governs proper maintenance of lab equipment.

Can The Athlete Challenge the Scientific Basis of an AAF?

We’ve stated on TBV that the WADA Rules prohibit an athlete from challenging the science used by a WADA lab to prove an AAF. As it turns out, this statement is not 100% correct. As we’ll see, many anti-doping cases are based on the athlete’s argument that the AAF is based on bad science.

The actual rule in this area is as follows:

• The UCI and WADA rules establish a presumption that a WADA lab has carried out its anti-doping tests in accordance with acceptable current scientific standards. See USADA v. Bergman, http://www.usantidoping.org/files/active/arbitration_rulings/CAS%20Decision%20-%20Bergman.pdf, p. 12.

• This presumption of validity extends into three potential areas of challenge: the scientific basis for the test, the analytical result (for example, the chromatograms on which the FL AAF was based), and the interpretation of the analytical result. Id.

• The athlete can overcome this presumption of validity by presenting proof that the test as designed, performed or interpreted is not scientifically valid.

There are a number of anti-doping cases where the athlete has attempted to challenge the scientific basis of the AAF. For example, in USADA v. Hamilton, http://www.usantidoping.org/files/active/arbitration_rulings/AAA_CAS%20Decision%20-%20Hamilton[1].pdf, Tyler Hamilton challenged the scientific basis of his blood doping AAF, arguing that the blood doping test used to convict him was insufficiently validated, should have been based on a quantitative rather than a visual standard, and proved only that he had a “mixed red cell population” (which could be explained by circumstances other than blood doping). See Hamilton Decision p. 4. The arbitration panel in the Hamilton case rejected Hamilton’s arguments on scientific grounds, but there is no suggestion that Hamilton was precluded by the WADA Rules from raising scientific objections to the anti-doping tests.

Similarly, in the USADA v. Bergman case cited above, Bergman unsuccessfully challenged the scientific basis of the WADA lab’s interpretation of the rEPO testing used to prove Bergman’s AAF. As with the Hamilton case, the CAS rejected Bergman’s arguments on scientific grounds, and noted the presumption under the WADA and UCI rules in favor of the lab’s interpretation of Bergman’s rEPO tests. However, there is no suggestion in the Bergman case that the WADA or UCI rules barred Bergman from challenging the science behind the rEPO testing.

From the above, we learn that the WADA and UCI rules set up a presumption that all AAFs have a valid basis in science. The athlete can challenge this presumption – there is nothing in the rules preventing the athlete from challenging any aspect of the science behind an AAF. However, to my knowledge, no such challenge has succeeded to date.

Up to the Introduction; On to part 2.