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Ready for take-off … ?

With the introduction of Regulation (EU) 2018/10421 the European Commission has amended Regulation (EU) 965/20122 and in doing so has presented the European airline industry with new challenges. The carrying-out of random and systematic alcohol and drug impairment checks is designed to ensure the airworthiness of flight and cabin crew. Regulation (EU) 2018/1042 was originally to enter into force on 14 August 2020. This date has now been postponed to 14 February 2021 due to the corona pandemic3. So what needs to be done by then? And by whom?

Background

The new regulation and a whole range of other changes in the airline industry were prompted by the crash of Germanwings flight 9525. On 24 March 2015, an Airbus A320 smashed into the Western Alps while en route from Barcelona to Düsseldorf, killing all 150 passengers and crew. The final report into the crash by the French air accident investigation authority (BEA) concluded that the co-pilot crashed the plane in a deliberate and planned act, while he was alone in the cockpit 4. Subsequently, the European Aviation Safety Agency (EASA) issued new recommendations and paragraph 4a was added to the German Air Traffic Act ("LuftVG") 5.

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Lastly, in 2018 the highest authority in the European Union reacted by passing Regulation (EU) 2018/1042, amending Regulation (EU) 965/2012. Regulation (EU) 965/2012 as amended is effective immediately in all member states and establishes provisions for commercial airline operations relating to aircraft and helicopters. The new regulation includes mandatory systematic testing by airline operators of flight crews and cabin crews for psychoactive substances.

Link to the individual air travel authorities in all countries

General Information on Alcohol and Drugs Policy

According to the (EU) 965/2012 und (EU) 2018/1042 regulations, a European airline must "take all reasonable measures to ensure that no person enters or remains in an aircraft when under the influence of psychoactive substances to the extent that the safety of the aircraft or its occupants is likely to be endangered."

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The test methods to be used to achieve this are not stipulated, but non-binding recommendations have been issued by the EASA to illustrate provisions for putting the measures into practice and to contribute to their standardised implementation6, 7.

According to these, a non-invasive alcohol breath-testing device should be used to check for evidence of the presence of alcohol8.

Initial drug detection can be performed using an immunochemical testing procedure9.

Alcohol & Drug Testing

Alcohol Testing

Alcohol checks are quickly and very easily carried out by means of breath tests. The tests work reliably and are long-established in use by the police and other authorities. But even here there are differences in quality. Cheap breathalysers mostly use what are known as semiconductor sensors to measure the breath alcohol concentration. In contrast, the devices employed by the police use electrochemical sensors.

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The use of semiconductor sensors does indeed make for low prices, but also results in unsatisfactory measuring accuracy. The very limited usability of semiconductor sensors is fundamentally due to two reasons. First, the sensitivity of semiconductor sensors is inherently unstable. Over time, they drift, and this leads to false concentration readings. Consequently, the alcohol concentration readings are often too low. In addition, semiconductors not only measure alcohol in the breathing air, but can also be sensitive to other substances that people can exhale, such as carbon monoxide from cigarette smoke, or acetone and ammonia from people with certain medical conditions such as diabetes.

If reliable measurement results are important, it is imperative that high-quality meters with electrochemical sensors are used. This technology has proved itself in professional use over many years and has demonstrated its reliability time and again all over the world. This is why all Dräger handheld Alcotest devices are fitted with electrochemical Dräger sensors.

Drug Testing

For tests on other psychoactive substances, various drug testing methods are available. Non-invasive testing procedures can be used in the lab on test materials such as oral fluid, urine and hair. On-site testing of a sample using an immunochemical assay is only possible with urine and oral fluid. By comparison, urine tests are often cheaper, although significantly more cumbersome than oral fluid tests, since sanitary facilities and a same-sex observer are required for sample collection.

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However, how urine and oral fluid differ with respect to the detection period of drugs is much more important. The active substances of the drugs can be detected in oral fluid, as in blood, so that conclusions can be drawn about an acute impairment. This window of detection can last for up to one day after consumption (fig. 1). With urine, on the other hand, drug testing is generally based not on the detection of the original active substance itself, but of the metabolites created by the substance. This means that although a generalised consumption can be established for up to a few days prior to the test, no certain conclusions can be drawn about when in those days the user took the drug and was under its influence.  

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Ultimately, therefore, the choice of appropriate test method should be based not on price, but on the actual spirit and purpose of the test – and Regulation (EU) 2018/1042 sets this out this very clearly: "The operator must take all reasonable measures to ensure that no person enters or remains in an aircraft when under the influence of psychoactive substances to the extent that the safety of the aircraft or its occupants is likely to be endangered."

This clearly prescribes that a test must confirm an acute impairment. An oral fluid test meets this requirement. Evidence of consumption having taken place weeks earlier can, in this case, be more of a hindrance than a help.

Fig. 1: Detection windows of drugs in different test materials.
(From: Caplan & Goldberg, 2001, J.Anal. Tox 25, 396-399)

Sample Testing Programme

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The following diagram (fig. 2) is designed to illustrate the possible sequence in a testing programme. First, a test subject is selected randomly. Only this person is told about the test; other crew members are not. If the test subject refuses to take the test, they are not allowed to report for duty. Generally, though, a test will take place and a negative result indicated. The procedure only takes a few minutes and the aircraft can then take off as planned.

If the test result is not negative, the test subject can be offered a second "B" test. As with the first test, if the result is negative, there are no consequences. If the second test result is also positive, however, the person involved is not allowed to fly.

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Fig. 2: Sample test programme for alcohol and drugs

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European Union Aviation Safety Association

The European Union Aviation Safety Association (EASA) have recommended Draeger Alcotest devices on their ‘alcohol testing during ramp inspection’ document. Please click to see chapter 13.3 where this is highlighted.

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What is your challenge and how can Dräger help you with it?

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Your challenge according to (EU) 2018/1042 and Dräger's solutions

Whilst the European Commission does not explicitly stipulate any particular test methods in the (EU) Regulation 2018/1042, it does stipulate certain requirements regarding quality standards and implementation. This is where Dräger comes in. We offer testing devices for alcohol and drugs that meet these requirements. The following tables show the Commission's requirements and Dräger's solutions.

Alcohol tests

It is a requirement that the test method be non-invasive.

In contrast to blood tests, breath alcohol tests are non-invasive.

The legal limit is 0.2 per mill, or 90 µg/L breathing air.

A Dräger alcohol breathalyser can easily indicate this value.

The tests must be capable of being used at any time so that a person can be tested spontaneously if there is probable cause.

Only portable devices such as the Dräger Alcotest® 5820, 6820 and 7510 can meet this requirement.

The test methods should satisfy recognised standards that guarantee accurate test results and comply with the prevailing national statutory provisions for alcohol tests.

Fitted with an electrochemical sensor, the Dräger Alcotest® 5820, 6820 and 7510 mobile testing devices are the latest, state-of-the-art technology and have been adopted for use by the police in Germany. The Dräger Alcotest® 9510 is a breath alcohol testing device for measurements that are admissible in a court of law. It meets national and international requirements and specifications (OIML R 126,DIN VDE 0405, SR 941.210.4 (CH)).

The test results must be entered in the central database without the personal data of the crew member concerned.

With a Dräger Alcotest® device, it is possible to test anonymously as well as to store the personal data of the test subject.

According to the regulation, no medical personnel are required for the test to be carried out. According to EU law, only if a positive result is indicated should a medical professional also be informed. However, the German LuftVG legislation stipulates that in Germany a doctor must be present.

In order to carry out a breath alcohol test with, for example, the Alcotest® 5820, medical personnel are not needed.

Drug tests

The list of psychoactive substances includes (along with alcohol) opioids, cannabinoids, tranquillisers, sleeping pills, cocaine, other psychostimulants, hallucinogens and volatile solvents.

The Dräger DrugTest 5000 can detect the following eight substances/classes of substance within predefined detection limits: amphetamine and methamphetamine (psychostimulants such as ecstasy), benzodiazepine (sleeping pills and tranquillisers), THC (cannabis), cocaine, opiates and methadone (opioids) and ketamine. The DrugCheck 3000 tests subjects for up to six classes of substance at the same time:  cocaine, opiates, amphetamine, methamphetamine and cannabis.

It is a requirement that the test method be non-invasive.

Sample collection of oral fluid using the Dräger DrugTest 5000 or the Dräger DrugCheck 3000 is non-invasive.

No-one should board an aircraft if they are under the influence of certain named substances.

In contrast to urine tests, an oral fluid test identifies the agents that are active in the person's system. This makes possible a timely assessment of the consumption and of the resulting influence.

The rapid test is a screening test; in the event of a positive result, a supplemental laboratory analysis is required.

Yes. Immunochemical tests can provide a timely indication of drug consumption, with little required in the way of analysis materials and preparatory work. As a general rule, all positive rapid test results should be checked using confirmatory methods.

Alcohol screening device / drug analysis system / documentation

Dräger Alcotest® 6820

Dräger Alcotest® 6820

The fast and compact Dräger Alcotest® 6820 alcohol detection device meets the stringent requirements of professional breath-alcohol analysis. With its tried-and-tested DrägerSensor, this robust alcohol tester guarantees very rapid response times and precise test results in all weather conditions and can also be adapted to international ...

Product details

Dräger DrugTest 5000

Dräger DrugTest 5000

No pipetting, no drips, no timing: With the Dräger DrugTest 5000, a drug test is carried out simply and quickly. The collected saliva sample can be analyzed immediately - for accurate results on the spot.

Product details

Dräger Alcotest® 9510

Dräger Alcotest® 9510

The Dräger Alcotest® 9510 is an advanced breath alcohol measuring instrument for evidential applications. It is designed to comply with national and international requirements and regulations (OIML R 126). With dual sensor technology, intuitive color touch screen interface, and modern design the Alcotest® 9510 sets superior standards.

Product details

Dräger Mobile Printer

Dräger Mobile Printer

The Dräger Mobile Printer prints breath alcohol and drug test measurement results directly on the spot.

Product details

Sources

  1. Regulation (EU) 2018/1042 (https://www.easa.europa.eu/document-library/regulations/commission-regulation-eu-20181042)
  2. Regulation (EU) 965/2012 (https://www.lba.de/SharedDocs/Downloads/DE/B/Rechtsvorschriften/VO_965_2012.pdf)
  3. Commission Implementing Regulation (EU) 2020/745
    (https://www.easa.europa.eu/document-library/regulations/commission-implementing-regulation-eu-2020745)
  4. Final report, Accident on 24 March 2015 in Prads-Haute-Bléone (Alpes-de-Haute-Provence, France) involving an Airbus A320-211 aircraft registration D-AIPX operated by Germanwings; Bureau d’Enquêtes et d’Analyses pour la sécurité de l’aviation civile. 13 March 2016; downloaded on: 14 July 2020
  5. LuftVG §4a (https://www.gesetze-im-internet.de/luftvg/__4a.html)
  6. Acceptable Means of Compliance (AMC) and Guidance Material (GM) to Annex II Authority requirements for air operations of Commission Regulation (EU) 965/2012 on air operations. Consolidated version including Issue 3, Amendment 9. 1 March 2019 (https://www.easa.europa.eu/sites/default/files/dfu/Consolidated%20AMC-GM_Annex%20II%20Part-ARO_March%202019.pdf), downloaded on 14. Juli 2020.
  7. Annex to draft decision AMC1 ARO.RAMP.106(a) (https://www.easa.europa.eu/sites/default/files/dfu/Draft%20AMC-GM%20to%20part%20ARO%20%28for%20information%20only%29.pdf)
  8. Chapter AMC1 ARO.RAMP.106 Alcohol testing, GENERAL — ALCOHOL TESTING METHODOLOGY, (b) 1
  9. Chapter AMC1 CAT.GEN.MPA.170(c) Psychoactive substances, OBJECTIVE, TRANSPARENT AND NON-DISCRIMINATORY TESTING PROCEDURE, (e) 3

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