Strictly speaking

Thursday, 17 February 2011

Radar

The debate over Alberto Contador is far from finished. The WADA Code adopted by the UCI involves the concept of “strict liability”. In this case an athlete is responsible for what goes in their body and if a banned substance is discovered they face a sanction, normally a two year suspension.

It’s for the individual to present reasons to explain the positive test, if they think it came from contaminated supplements or illegal meat, the onus is on them to prove it. Now this is very harsh, the presumption of innocence is put aside. But strict liability is common across many fields, it is not curious to sports and anti-doping codes. Here’s Wikipedia:

A classic example of strict liability is the owner of a tiger rehabilitation center. No matter how strong the tiger cages are, if an animal escapes and causes damage and injury, the owner is held liable. Another example is a contractor hiring a demolition subcontractor that lacks proper insurance. If the subcontractor makes a mistake, the contractor is strictly liable for any damage that occurs.

The law imputes strict liability to situations it considers to be inherently dangerous. It discourages reckless behavior and needless loss by forcing potential defendants to take every possible precaution. It also has the effect of simplifying and thereby expediting.

Hopefully you get the picture. But let me drive the point home. In France the speed limit is 50km/h in residential areas. Now imagine you get a letter from the police informing you that car has been caught doing 55km/h, complete with the photo evidence from a speed camera. You could argue that you weren’t driving dangerously but the law puts the limit at 50km/h so you are going to have to pay the fine. Now maybe you didn’t know you were over the limit. You have to pay. Maybe your car was out of control. You have to pay. Maybe you weren’t in the car. You have to pay. And so on, the only way to escape the penalty is to prove you were not at fault, for example to prove that a friend had borrowed the car and get them to testify.

It’s the same deal with anti-doping rules. Just as breaking the speed limit by a tiny amount is banned, so is having a tiny amount of a banned substance. Unlike, say, testosterone, there is no tolerated quantity allowed for Clenbuterol. The presence of any Clenbuterol can aid performance so it doesn’t matter where it comes from, the rider is doped whether it is deliberate or accidental.

What the Spanish federation has done is to say “you didn’t have much Clenbuterol and it could have come from some beef”. It’s the equivalent of the police saying “you weren’t that much over the speed limit and maybe you weren’t driving”, a departure from the normal traffic rules. If a local magistrate tried that in France they’d get suspended.

Given all this WADA is going to appeal, just as someone escaping French motoring law would see the authorities appeal rather than a new precedent of jurisprudence case law.

Advising Alberto
The ruling from Spain looks very weak. The presence of Clenbuterol is incontrovertable and there’s no proof of where it came from. That’s a two year ban.

Tragically even if Contador is innocent my advice would be not to fight this unless the proof can be found. Tracing the source is his best hope but without this he looks stuck. It’s the equivalent of someone taking your car, getting flashed by a speed ticket and then returning the car : you have no alibi to state it wasn’t you, many a traffic cop would laugh, worse a magistrate might be inclined to make an example of you. Even if you are innocent, establish the proof might be an impossible task. The only certainty is is the lawyer’s invoice.

Spain vs. WADA?
Still, if he wants to go ahead Contador’s needs to overturn the WADA Code. He might be wealthy, he might have good lawyers but this is surely a task too far? His only hope would be to get the Spanish government behind him and take a big tilt at WADA. But I suspect that even one country can’t do that without upsetting the IOC and jeopardising the country’s access to international sport.

Fran Reyes February 17, 2011 at 2:35 pm

Well, there are so many considerations in the decision of RFEC which haven’t been showed publicly. Example: the cow “whose” meat Contador allegedly ate was from a farm which was sanctioned for using clenbuterol in 2000. In the European Union clenbuterol is not allowed; so there is no negligence or fault in Contador not analysing the meat before eating it…
So the question is: what rule do we take? The no negligence = no sanction or the drug = sanction?

TdF Lanterne Rouge February 17, 2011 at 2:43 pm

Do you have a source on that meat origin, Fran? I haven’t seen that statement elsewhere.

The Inner Ring February 17, 2011 at 2:45 pm

Fran Reyes: if he can make the link to a farm then it’s essential for him to do this and to explore this. But like I say even if he is innocent, he could get sanctioned. That’s why the evidence is so important and going to the farm, if not the cow, is very important. This should have been done in July.

Robert February 17, 2011 at 3:27 pm

Fran Reyes : the point you make, if correct, about the farm where this meat comes from, in my eyes, makes AC more, not less, negligent ! To have eaten meat that came from a farm known in the past to have a problem with Clenbuterol and still not test it seems reckless in the extreme ! In any case, I think it is a dead end – either ‘strict liability’ means what it says or it doesn’t. If WADA let this go I can see a whole host of retrospective cases being reopened eg Alain Baxter (the skiier).

CT February 17, 2011 at 3:40 pm

Agree with Robert.

Besides — in 2008, a test of meat samples from EU was conducted. In total, 300,000 samples were tested, only one showed the possibility of clenbuterol contamination.

The Inner Ring February 17, 2011 at 3:41 pm

Robert: I’m presuming the info on the farm appeared during the investigation, not before! As you say with the appeals WADA just can’t let it happen. There is the turkey/Christmas vote of a bureaucracy wanting to protect its turf but the principle of the Code should be important to sport too.

TdF Lanterne Rouge February 17, 2011 at 3:46 pm

I’ve been saying from the start that if someone had REALLY been poisoned by clenbuterol contamination, they have the responsibility to fellow consumers to IMMEDIATELY (as soon as it’s known, e.g., last July) launch a massive food safety investigation to track down the origin. Contador and his legal team didn’t do this. Neither did any government official.

The only possible reason I can think of is that it’s a story concocted after the fact.

Fran Reyes February 17, 2011 at 3:47 pm

@ TDF / Inner Ring
Well, it is said on the allegations of Contador, page 3. You can read it here: http://estaticos.elmundo.es/documentos/2011/02/09/alegaciones_contador.pdf

@ Robert
When going to a shop and buying some meat, no one gets information about where does the cow come from. And, anyway, how can Contador go an search for the origin of the meat and take a look at the farm history to see if it has been sanctioned? Makes no sense!

Simma February 17, 2011 at 4:07 pm

@fran, last year contador said his friend brought the meat specifically for him as a treat from spain, no purchase, he should have known exactly where it came from before it was even cooked… riders negligence is definitly the case. Plus supposedly the whole team except vino ate it, team manager should of wanted it tested too :-/ if he was innocent his laywers surely would of immediatly said “hey lets go find this cow/farm and your home free”, they didn’t… looks like he’s just been advised on a previously sucessfull cover story and ran with it before checking facts… for the sake of wada and uci, I hope he gets 2 years… there needs to be zero tolerance for our sport to stay alive…

TdF Lanterne Rouge February 17, 2011 at 4:11 pm

Thanks for the link – but I think Contador’s legal team and government officials had a public health responsibility (as well as their responsibility to find exculpatory evidence) to follow up and track down clenbuterol contamination allegations more recent than eleven years old.

Paul February 17, 2011 at 4:47 pm

I think the speeding fine comparison may be a little unfortunate in this case given the tiny amount of clenbuterol found in Contador’s blood samples. As I understand it, there is a 10% allowance to compensate for any inaccuracies in speed testing equipment. So while the speed limit may be 30mph, you have to be travelling at 33+mph for a fine to be incurred.

The Inner Ring February 17, 2011 at 4:55 pm

TdF: it is a valid point to say to the Spanish government that if they support Contador, what does this say about their food safety?

Paul: ok, it was only an analogy. I just wanted an example to show it’s not something arcane in the sports rule book, it’s an everyday thing. Society relies on the principle to function. But if you plan on driving in France… note in France that 1km/h over the limit and the camera flashes, there is practically no margin.

Angelo senza la o February 17, 2011 at 5:06 pm

ASOPROVAC, the Spanish Association of Beef Cattle Producers, has come out with the following statement today: “Los ganaderos acusan a Contador de manchar el buen nombre de todo un sector para tratar de limpiar el suyo propio sin aportar prueba alguna. Alberto Contador ha sido finalmente absuelto por la Federación Española de Ciclismo (RFEC) después de presentar una serie de alegaciones a las que la Asociación Española de Productores de Vacuno de Carne (ASOPROVAC) ha tenido acceso y en las que el corredor arremete impunemente y faltando a la verdad contra este sector productor, poniendo en tela de juicio los exhaustivos sistemas de control a los que se somete la carne de vacuno en la Unión Europea y, por ende, en nuestro país.” Loosely translated, “The cattle producers accuse Contador of staining the reputation of an entire industry without any evidence in trying to clear his own name. Alberto Contador has been finally cleared by the Spanish Cycling Federation (RFEC) after presenting a series of allegations to which ASOPROVAC has had access to. Contador, with impunity, and lacking any truth, puts into question the comprehensive control systems that are applied to beef in the European Union and, therefore, in our country. ”
see: http://www.asoprovac.com/Asoprovac/Zona%20P%FAblica/gabinete%20de%20comunicaci%F3n/notas%20de%20prensa/NewsModule/displayNews/a1b10007f63482e039c0875a32d1a1e3/76d7417a291ba158fdb415b2a8724697/

davidh February 17, 2011 at 5:20 pm

Aside from feeling anger with the REFC, I also find myself feeling very disappointed in Bjarne Riis. Say what you will about his actions in the 1990s, I think his actions in 2006-2007 (instituting an internal testing program, his own confession) provided some measure of redemption, and he gave some signs of that he truly had gotten religion. But by allowing Contador to race for his team on the back of such a flimsy decision strikes me as ethically flawed and unwise. Contador’s return to racing under these circumstances is manifestly bad for the sport – bad publicity, bad precedent, and – if things proceed as you surmised in your posting on the prospect of a disallowed Contador victory in the 2011 Giro – utter farce. As a fan, I am wondering why I shouldn’t just tune out after the Classics season.
I realize Riis is playing with a rather weak deck; I’d like to think that in a stronger financial/sponsorship position he’d bench Contador until this is sorted out on respectable grounds. But I am still angry.

Miso Kuropka February 17, 2011 at 5:30 pm

The analogy with the speeding ticket is good, but not bullet proof. The first thing that the lawyer would do is to ask for the validation certificate of the camera hoping that there something wrong with it. This would make the evidence for the fine insufficient. This is exactly what Contador and his lawyers are doing. They bending (understand abusing) both the material and procedural law to make him absolved. I believe that even if they can track the stake to a farm that was fined for Clenbuterol 10 years ago, this is very circumstantial evidence insufficient for exoneration under strict liability. Unless Contador is able to track his multivitamin stake to exact farm (which he should under the EU law) and substantiate that the farmer fed Clenbuterol to his herd at the time corresponding to his positive test. Even than I would not believe him and would consider it as work of his legal team. And now he goes even further and is trying to persuade us that regulations on doping need to be revised in order to bring them into line with recent advances in testing technology (see http://www.cyclingnews.com/news/contador-its-a-great-step-forwards-for-the-sport). What a nonsense. If we are to get rid of doping even stricter liability should be introduced, i.e. once doper always doper. And not only in a legal terms (lifetime ban), but also on moral one, i.e. they should not be allowed to participate in any form in professional sport. Basta! I understand that this would be very cruel to nice guys like Basso or Millar. But it is for the greater cause. Otherwise you end up with people like Vinokurov (doper who wants his TDF prize money), Riss (doper who needs EL DOPELERO on his team) Rassmusen (doper who wants the public sympathy) and the majority of Spanish pros (some of the dopers) all persuading us that EL DOPELERO is innocent.

The Inner Ring February 17, 2011 at 6:47 pm

davidh: there’s something special about the way Riis always bounces back. I think his policies, eg the Damsgaard screening program, are usually good for business.

Miso Kuropka: yes, just an analogy to make an example. It’s not meant to be a parallel of the case. Life bans are an interesting idea, I’m in two minds. On the one hand only a few get caught so they are not a solution. But we do see a high rate of reoffending so yes perhaps they have their benefits. I would be in favour of a four year ban for anyone caught in blood doping or something else so obvious.

Rod February 17, 2011 at 7:23 pm

One additional data point – clenbuterol accumulates in hair. So have Contador submit a sample. This won’t clear him if “clean”, but would point to systematic clenbuterol use since it accumulates in hair.

One more “piece” if you wish.

The plasticizers in blood is even trickier… since the stupid test is not even validated it makes no point in even arguing about it. It makes me absolutely bonkers when the people in charge of these things (WADA, UCI, etc.) use effing non-validated methods and tests. This is where all the discourse ends: there are no rules, on either side:

You can be part of a wealthy sport: clear (e.g. football, FIFA, and the swept Puerto players that we don’t even know about).
You can be sworn to provide professional, anonymous testing services but you leak to the press all the time (see L’Equipe).
You can have a sympathetic sports organization (i.e. Gasquet’s “I was kissed by a coke-girl” explanation in Tennis – did he provide a sample of the “girl”?)
You can be a superstar and have people with vested interests fight for you (A.C.)
You can provide/receive an “anti-doping” donation irrespective of the huge conflicts of interests this entails (see LA and UCI).

So, it is a big effing mess, and a free for all. If you’re not in those categories above – well, you’re well screwed. Ask Fuyu Li.

The sport’s authorities are full of corruption and conflicts of interest (see McQuaid’s family businesses), and the system’s so broken that pretty much ALL sanctions are discretionary. The rulebook might as well be thrown out and state “we’ll discuss your case, our lawyers will charge their appropriate fees, and we’ll get back to you in a year (or four, ask. Piti).

Where I do agree with AC is that there’s a huge gap in the antidoping code establishing strict no-detection (i.e. zero) limits on substances that could CONCEIVABLY be ingested unwittingly. If the science is there to detect things, there’s a reason to use things appropriately. I’m not saying this is the case, but what if on the eve of racing the final TT of the Tour the cleanest rider gets sprayed (by accident or otherwise) with someone’s asthma inhaler. With sensitive enough equipment (and picograms per liter IS pretty sensitive) you could detect this. Should the athlete be banned? Just put a “no physiological effect” level that makes sense and allows for the fact that we live in a dirty, messy world (newsflash – the bottle of soda you use HAS plasticizers. So does your plastic container. Did you microwave your lunch in it?).

I am not saying Contador is innocent – but for me that is now secondary to the fact that the rules are hardly worth the paper they’re written on. To have fair competition, you need a clear set of guidelines with proper enforcement.

TdF Lanterne Rouge February 17, 2011 at 7:40 pm

If they set minimal acceptable levels of banned drugs to cater to the “environmental contamination” lobby, then we’re just going to get cases in another ten years with higher levels of dope detected and pleas of “I didn’t dope! I just ate a really, really, REALLY contaminated piece of meat!”

The Inner Ring February 17, 2011 at 7:44 pm

Rod: note the plasticiser talk is just that. There is no public statement on it. Labs do test samples all the time for new things using unvalidated tests. For some time the Lausanne laboratory was detecting EPO when the test was not validated. But you just cannot convict of course.

TdF Lanterne Rouge: exactly. Set a limit and it encourages people to dope up to it, leaving any healthy rider further behind.

ColoradoGoat February 17, 2011 at 7:53 pm

As an aside – since accidental ingestion does not absolve one from being caught doping, then wouldn’t the admission that all other riders (aside from VINO) result in sanctions against those riders, since the team is now admitting as well that those riders were riding around with a banned substance?

Baruch February 17, 2011 at 8:58 pm

From Black’s Law Dictionary.

Strict Liability. (1844)
Liability that does no depend on actual negligence or intent to do harm, but that is based on the breach of an absolute duty to make something safe. Strict liability most often applies either to ultrahazardous activities or in products-liability case..—Also termed absolute liability; liability without fault.
****
A related concept:

Outcome Responsibility
The view that those who cause harm are responsible for it even in the absence of fault.

Bud February 17, 2011 at 9:18 pm

Is there any science out there on the level of clen found in Contador as it relates to the steak he consumed? For example, a 12 oz cut of sirloin consumed at such and such a time on the day before the positive test contains what amount of steroid since x amount was found in Contador’s urine? Does the stuff have a half-life, is it dissipated by cooking, does the cooking method matter, etc? Common sense would seem to suggest that one could extrapolate backward from the level in Contador to what amount would have had to have been in the meat a day before to produce that result. The answer would let us know if Contador is at least in the theoretical ballpark with his claim that the clen was in the meat.

The Inner Ring February 17, 2011 at 9:34 pm

Colorado Goat: they might have eaten the steak but there’s no admission.

Baruch: thanks, a clear explanation

Bud: see http://www.sportsscientists.com/ and have a look around.

ColoradoGoat February 17, 2011 at 11:48 pm

Inner Ring –

my point was that if A) Steak was contaminated with Clen; B) Riders on Astana consumed Clen, then C) All riders who consumed contaminated steak were riding with a banned substance in their bodies.

They have implicitly indicted themselves through this finding. If I am WADA, I would come out an say:
‘Well Alberto, we do not care how Clen got in your system, but we will even agree it was through consumption of steak. You are still banned. Oh – and by the way, since you have so clearly indicated it was steak, and since you and your team and cook admitted all except Vino ate the Steak, we now have evidence of all 7 of those TdF Astana riders also having violated the code. Enjoy”.

Miso Kuropka February 18, 2011 at 2:15 am

My arguments for life ban are as follows:

1.I see 3 fundamental objectives behind any penalty: PUNISHMENT (you cheated, you would be banned). PREVENTION (everybody knows that cheating ultimately leads to penalty/ban, thus will not take the risk of cheating). REDEMPTION (you pay your dues for the wrongdoing/cheating, hopefully you learned your lesson, thus it is assumed that you can be trusted in the future).
2.REDEMPTION. Certain wrongdoings are so severe that redemption cannot be achieved or it is not desired. If we consider criminal law for analogy (because there is the most developed reasoning behind penalization), if one commits inhumane crime he does not deserve a second chance and should be confined for the rest of his life (in the civilized world) or killed (in Texas).
3.DOPING: ULTIMATE WRONGDOING AGAINST SPORT FUNDAMENTALS. I believe that as far as cycling is concerned, doping represent the ultimate wrongdoing. Doping undermines/corrupts the fundamental principle of the sport, i.e. fair game (the one who tries the most; trains the most; is talented the most wins. as opposed to one who wins because he cheated). If we accept doping in any form, the sport turns into orchestrated puppet show. I as a cyclist and a fan cannot accept that pro cycling turns into puppet show and money making machine (as it seems for the last 15 years). I still see pro cycling as a sport, the same thing that we amateur cyclist do. We ride our bikes and it motivates us to see that some people are able to do the same thing better. Thus, we as fans/amateur cyclists cannot accept that the whole pro level is based on a lie. Not to say that we are also contributing to the costs of the whole show (as the money we pay for our Specialized bikes, Selle Italia saddles, SIDI shoes include portions paid for Contador’s endorsements). Given this, dopers are to cycling what mass murders are to general society, i.e. the ultimate wrongdoers committing ultimate crime deserving ultimate penalty with no redemption/mercy/human understanding.
4.PREVENTION. Currently, when a pro contemplates doping/cheating he understands that it is very unlikely that he is not going to get caught (when sticking to autologous transfusion). And even if tested positive, he knows that he should be allowed to come back (provided that he does not say anything a takes all the blame). The situation would change drastically, if he knows that there is a clear line that cannot be crossed. And if you do, you doomed (banned for life). I do not see such approach (life ban) as unreasonably cruel or unjust punishment. Just consider: when a doctor causes harm to a patient (even negligently), he will not be allowed to work as a doctor in the future; when a student cheats he will be kicked out of university; if lawyer commits a fraud, he will not be allowed to practice law.
1.THE RULE OF SILENCE vs REDEMPTION/PREVENTION. Generally, when a pro tests positive, he remains silent, taking all the blame. Hoping that after the ban, he will ride again. However, every reasonable person comprehending the level of the anti-doping controls assumes that doping requires sophisticated level of organization and it is very unlikely that it is done on individual (rider on his own) basis. In other words, secret world with rules of its own, disregarding the views of outsiders. Analogously, mafia and its omerta. The very few who tried to break omerta and wanted to provide an insight into the secrets of doping ended up as constant liars, fools, you name it. And it was not the general public/insightful fans who did it. Their were ostracized by their own peers. The omerta rule could be broken if those who have no chance of returning (into the pro cycling) want to ease their consciousness and find fairness (like when a domestique is banned for life seeing his cheater captain taking all the fame/money).
2.PUNISHMENT. Considering all the above, I believe that is fair to punish the dopers with the life ban when the rules clearly state that the risk of doping leads to it. It is true that some who dope will never get caught (thus it appears cruel to those who get caught). But, the issue that not everybody is caught is not a problem of penalization but rather of a detection (life ban penalty is fair).
In other words, if you look to the history of pro cycling, everybody testing positive was a doper (there is no eligible case of a rider who was found guilty based on wrong evidence). Thus, one should accept that dopers needs to be punished. And if one agrees to take the risk of doping understanding that the penalty for being caught is a life time ban, I would consider it as a fair punishment. Nevertheless, we should also try to make the detection mechanisms as efficient as possible, so everybody cheating gets caught.

Jii February 18, 2011 at 2:35 am

100% agree with Miso. Life ban. Eliminate recidivism and set such a massive penalty that people would baulk at the idea of doping because the downside is too great.

Sadly there will be an innocent who undoubtedly gets banned for life. However I believe they will be a immaterial exception. As they are being banned from a vocation not killed or jailed I think it is a price that we as the ultimate arbiter of the sport can be comfortable with.

Touriste-Routier February 18, 2011 at 4:32 am

Life bans? Where do you draw the line? Accidental vs intentional consumption? Type of violation?

There are so many flaws with the standards of testing, rules of evidence, and integrity of the system. Until these are unified, and obeyed, as well as an independent 3rd party has been assigned jurisdiction (taking it away from National Federations, the UCI, and WADA/affiliates), talking about sentencing standards is putting the cart before the horse.

Miso Kuropka February 18, 2011 at 8:02 am

Touriste-Routier: Regardless how imperfect the anti-doping system is, it does not punishes the innocent ones. In other words looking to the past, I cannot find anybody who was wrongly (unfairly) sentenced for doping (e.g. based on fabricated evidence or no evidence at all). But I remember that most of those who tested positive never admitted doping, most of them trying to run free by pointing out that the system is not working. I am suggesting that the sport needs to adopt black and white approach to doping. Otherwise, the sport is not fighting doping but only pretends that there is any fight. I understand that this might appear rather strict, but it is not unfair. It is just a sport, anti-doping system is not putting people to jail, just stops them from competing. They still can return to society and try to make a living doing something else.

Take Valverde as an example. Unquestionable there is a clear evidence of doping violation (DNA sample). And he still has the indecency and arrogance to claim that he is innocent and the victim of the system with majority of Spain believing in him. And he is returning next year and will receive hero’s welcome. That is what I call imperfection of the system. If there were a life ban, there would be no need to deal with such crippled characters.

Touriste-Routier February 18, 2011 at 2:21 pm

Miso: I understand your passion and your sentiment, but doping has been made a crime in some countries (ex. Italy), and some athletes can go to jail, if prosecuted criminally. However, that was not my point. I have a degree in criminology; for punishment to be effective, it must be swift, strong, and certain, but the system must also be fair, and efficient.

The UCI/WADA system has low-to-no integrity. Different testing standards by the labs, supposedly blind testing results being leaked to the press, improper notification, national governing bodies showing partisanship, the UCI treating riders differently, a process that takes too long, very loose rules of evidence, etc. If these scenarios do not get corrected, than the farce will continue, played out in the media instead of through proper channels.

People place too much emphasis on admission of guilt and remorse. There is absolutely no incentive to admit to doping, whether one tests positive, is under investigation, or not. Reduced sentences and amnesty programs, properly administered, might do more for the sport than longer bans or outright expulsion.

The UCI is based in Switzerland, a country whose reputation is built on foundations of precision and efficiency. The UCI exhibits few of the traits.

Rod February 18, 2011 at 8:35 pm

“TdF Lanterne Rouge: exactly. Set a limit and it encourages people to dope up to it, leaving any healthy rider further behind.”

Agreed in principle – like the old Hematocrit 50% limit. But set the limit lower than reasonable doping effect use (NoEL, as in phisiology/toxicology). Issue solved there.

My wife’s vegetarian and I’m a flexitarian, so we tend to be careful to the origin of our food. But I still eat out and have no idea if the fish I’m ordering has high levels of mercury or other hormones.

Put it this way – if it is determined that estrogen-analogs can be used for doping (and there is some evidence, following the old “get pregnant and abort” coaching mechanisms of the old communist regimes) many milk drinkers and soy eaters will be screwed.

It is not hard to establish a physiological threshold for substances to have an effect- this is why tylenol is sold in “normal or extra strenght” and posology is indicated in the container. Or salbutamol/clenbuterol (for genuine asthma uses), where every puff is consistently dosed.

For what is worth, remember caffeine and its multiple debates for the antidoping list.

Set the WADA limits below “Negligible effect level”

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