Dec 2000/Jan 2001
 
Inside This Issue:
New Part 40 Reflects Industry Concerns
On December 14, 2000, the Department of Transportation (DOT) released 49 CFR Part 40, its revised regulations concerning drug and alcohol testing. DATIA comprised an analysis comparing the final regulations to the proposed regulations and DATIA's position on Part 40, which is located at www.datia.org.

DATIA members are commended on their substantial contributions and comments to the DOT docket in April 2000. This great effort had a positive impact on the outcome of the new rule.

Upon completion of our final review of the rule, DATIA is optimistic the majority of the rule will be favorable to the industry’s service providers and to the employers that must also comply with the new 49 CFR Part 40. The majority of the new rule goes into effect Aug. 1, 2001, to give employers and businesses adequate time to learn about its new provisions before the new regulations are required.  A few provisions, such as medical review officer review of suspected adulterated or substituted specimens, the split-specimen review procedures for validity testing, and the public interest exclusions provision, will go into effect on January 18, 2000. 

DOT also announced that it will hold public briefings on the final 49 CFR 40 rule on February 21 and 22, 2001 in Washington, DC at the FAA Auditorium. These meetings are open to all, free of charge, and are
expected to be the most comprehensive forum on the new 49 CFR Part 40. DATIA will hold a reception on the evening of February 21st for all DATIA members.

Some highlights to the new rule include a Public Interest Exclusion (PIE) section with 14 examples of non-compliant actions egregious enough to warrant a PIE proceeding. The scope of a PIE will be determined during the proceeding, but will apply to the services that are involved with or affected by the noncompliance that forms the factual basis for issuing the PIE.

Another highlight of the new Part 40 is that Consortium/Third Party Administrators (C/TPAs) are authorized to receive results from the Medical Review Officer (MRO), and transmit the results to the Designated Employer Representative.
Regarding the use of electronic records and signatures, the new rule permits greater use of faxes, scanned images, and electronic result reporting from laboratories to MROs. DOT is working with HHS to develop additional guidelines for increased use of electronic media in the future.

Read DATIA's side by side comparison of the proposed 49 CFR Part 40, DATIA's position, and the final rule at www.datia.org.

DATIA Meets with White House and SBA Regulatory Review Officials on Part 40
Top government officials heard industry concerns on unresolved issues relating to the Department of Transportation’s (DOT) rulemaking to change the mandatory drug and alcohol testing regulations, prior to the recently released 49 CFR Part 40 Rule. The meeting, which occurred on Monday, November 27 was requested by DATIA and included the White House’s review of DOT’s work before the regulation could be issued.
DATIA presented a comprehensive review and analysis of the DOT docket, which showed that 80 percent of the comments sent to DOT during the rulemaking process on the issue supported the DATIA position to allow “service agents” such as consortiums and third party administrators to serve as the agent of the employer. DOT had proposed to require each “actual employer” to have a Designated Employer Representative on staff to interface with the MRO, and prohibited employers from contracting this role out to service agents. DOT’s proposal, however, was supported by only 20 percent of the comments received, a decisive rejection of the proposal.

DATIA presented the relevant regulatory law that applied to the rulemaking including the Regulatory Flexibility Act, the Paperwork Reduction Act, and the Administrative Procedures Act, which required that impacts and costs be considered before releasing the final regulation.
DATIA’s other issues involved the quarterly statistical summary issue, and the blind sampling requirement in DOT’s notice of proposed rulemaking. DATIA made the point that both these requirements had no stated or empirical support, and therefore were of no “practical utility” as required by the Paperwork Reduction Act.

Invited by DATIA to accompany our presentation was a representative from the Society for Human Resource Management, a 150, 000 member association which also supported DATIA’s concerns on the Designated Employer Representative Issue. This meeting followed a recent meeting between DATIA and the Small Business Administration (SBA) where DATIA outlined the regulation’s impact on small business. Officials from SBA were also present at the White House meeting and are following it to ensure that it complies with the Regulatory Flexibility Act, which DOT claims it is exempt from.

Read DATIA’s comprehensive review of the DOT docket and the White House meeting at www.datia.org.

It’s The Law: Supreme Court Enforces Arbitrator’s Order to Reinstate Employee Despite the Employee’s Multiple Positive Drug Tests
By Tom Eden, Esq., Wallace, Jordan, Ratliff & Brandt, L.L.C.
On November 28, 2000, the U.S. Supreme Court ruled that courts could not refuse to enforce an arbitrator’s order to reinstate an employee who was fired twice after testing positive for marijuana and was reinstated by an arbitrator both times. In Eastern Associated Coal Co. v. United Mine Workers of America, District 17, 121 S. Ct. 462 (2000), James Smith, a mobile equipment operator, tested positive for cannabinoids as part of a random drug test. He was discharged. He filed a grievance under the collective bargaining agreement between his employer and his union. The agreement required reinstatement unless the termination was for “just cause.” The grievance was arbitrated, and the arbitrator issued an order returning Mr. Smith to work after a 30-day suspension without back pay. Mr. Smith was also required to take part in a substance abuse program and to be subject to random drug testing at the discretion of either Eastern or a substance abuse professional over a five-year period.

Mr. Smith tested negative for illegal drugs on four subsequent occasions between April 1996 and January 1997, but he tested positive for cannabinoids again on June 27, 1997. He was discharged, and he again filed a grievance. The arbitrator found that Mr. Smith’s lapse in abstinence from recreational drug use was an isolated occurrence instigated by a family problem, and that he had been a “good employee” for 17 years. The arbitrator ordered Mr. Smith to be reinstated after a suspension through October 27, 1997, subject to the conditions that he would receive no back pay, that he would reimburse the employer and the union for the costs of both arbitrations, and that he would provide a signed, undated letter of resignation which would be dated and accepted if he tested positive for any illegal drug, or refused to submit to a drug test, in the following five years.

The employer sought to have the award vacated in federal court, and argued that the reinstatement order violates public policy against the operation of dangerous machinery by workers who test positive for illegal drugs. The federal district court refused to vacate the award, as did the court of appeals, stating that because neither the collective bargaining agreement nor the employer’s substance abuse policy mandated discharge as the punishment for testing positive for illegal drugs, the arbitrator rationally could have concluded that there was not “just cause” for discharge. The courts also ruled that the arbitrator’s decision was not contrary to a “well-defined and dominant public policy because although there is a public policy against the use of illegal drugs by those in safety-sensitive positions, there is no such public policy against the reinstatement of employees who have used illegal drugs in the past.”

In a unanimous opinion, the Supreme Court framed the issue as whether the reinstatement requirement would fall within the legal exception that makes unenforceable “a collective bargaining agreement that is contrary to public policy.” The Court said that the question was not whether the employee’s conduct violated public policy, but whether the reinstatement does so. The Court held that the law did not forbid an employer from reinstating in a safety-sensitive position an employee who has failed a drug test once or twice, especially where the employee has been required to undergo a substance-abuse evaluation or treatment, has passed a test to return to work, and is subject to future random drug tests.

The Court concluded that the arbitrator’s decision was consistent with DOT rules requiring completion of substance-abuse treatment before returning to work. The Court also noted that the decision did not preclude the employer from assigning the employee to a non-safety-sensitive position until the treatment was completed. The Court said that neither Congress nor the Secretary of Transportation had seen fit to mandate the discharge of a worker who twice tests positive for drugs, and it would not infer a public policy into this area that goes beyond the careful and detailed scheme created by Congress in the Omnibus Transportation Employee Testing Act of 1991 and the regulations issued by the Secretary of Transportation.

It is advised that all form last chance agreements be strengthened to provide for immediate termination (or automatic resignation) upon a subsequent positive test result or refusal to be tested. The value of a well drafted last chance agreement when allowing an employee who has tested positive to return to work is significant. If an employer wants to make termination a requirement of a positive drug test after a return to work, it should specifically state this in any last chance agreement, drug policies, employment contracts, and collective bargaining agreements.

DISCLAIMER: The above should not be construed as legal advice or legal opinion as to any specific facts or circumstances. The contents are intended for general information only, and you are urged to consult your attorney concerning your own situation and any specific legal questions you may have. Tom Eden is a management labor attorney with the law firm of Wallace, Jordan, Ratliff & Brandt, L.L.C. who advises collection sites, TPAs, employers, work comp administrators, and MROs on a variety of drug and alcohol testing issues and risk reduction programs. Tom may be reached at (205) 870-0555 or te@wallacejordan.com. Please visit our web site at www.wallacejordan.com (which contains federal drug testing regulations and other drug free workplace resources).


Washington Update
FAA Proposes $172,500 Fine Against Chautauqua Airlines for Employee Drug and Alcohol Testing Violations

The Federal Aviation Administration (FAA) proposed to impose a $172,500 civil penalty against Chautauqua Airlines, Inc. for failing to conduct pre-employment and random drug and alcohol testing for safety-sensitive employees. The Indi-anapolis-based air carrier has 530 employees and operates 29 aircraft that provide scheduled service to and from 19 cities in the Midwestern United States.

The FAA's inspection of Chautauqua's anti-drug and alcohol misuse prevention programs in October 1997 and August to September 1998 revealed the company allegedly used 21 employees to perform safety-sensitive functions when the carrier had not received verified negative pre-employment drug test results. Subsequent to their performance of safety sensitive functions, the carrier has received verified negative drug-test results on these employees. The safety sensitive functions included aircraft maintenance, preventive maintenance, and aircraft-dispatch duties.

Additionally, in 1996 Chautauqua was required to conduct random drug and alcohol testing on 25 percent of its 280 employees who perform safety-sensitive functions. However, the inspection report alleged that the carrier performed only 47 random drug tests and 40 random alcohol tests.

Chautauqua has been affiliated with U.S Airways since 1973. The company has annual revenues of approximately $70 million. Chautauqua has 30 days from receipt of the FAA notice to submit a reply to the agency. This announcement is made in accordance with the FAA's practice of releasing information to the public on newly issued enforcement actions involving penalties of $50,000 or more.


Medical Marijuana Case Goes to Supreme Court

Granting the federal government's request that could decide the fate of an Oakland marijuana club, U.S. Supreme Court justices recently agreed to review whether cannabis should be legalized for the critically ill.

The decision was the latest victory for government lawyers, who have wrestled with marijuana advocates for nearly three years in federal courtrooms since the passage of California's Proposition 215, which exempts patients and defined caregivers who possess or cultivate marijuana for medical treatment, recommended by a physician, from criminal laws which otherwise prohibit possession or cultivation of marijuana. Proposition 215 also states that physicians who recommend use of marijuana for medical treatment shall not be punished or denied any right or privilege.

The Supreme Court will decide whether there is a "medical necessity" for sick people to use marijuana, which is allowed under Prop. 215. Government lawyers have contended that the proposition, along with similar initiatives approved in eight other states, interferes with enforcement of the federal Controlled Substances Act.

Passed in 1996 with 54 percent of the statewide vote, Prop. 215 allowed for critically ill patients to benefit from using marijuana for symptoms of diseases like cancer and AIDS. However, the initiative, which passed with 71 percent of the vote in California’s Alameda County and 63 percent in Contra Costa County, was viewed as vague and overly broad.

Complicating the issue even more, government officials do not recognize any medical evidence that suggests there are benefits associated with marijuana consumption. The federal government’s “War on Drugs” effort considers marijuana use in any capacity as illegal.

Still, the issue has gained nationwide support in the four years since both California and Arizona passed the measures. Voters in Alaska, Hawaii, Maine, Oregon, Washington, Nevada and Colorado all have approved similar laws.

The court's acceptance of the case brings to the forefront the question of legalizing marijuana in some cases. The court's ultimate decision could have nationwide implications for sick individuals.

 


Top-Notch Speakers at DATIA’s 5th Annual Conference in Phoenix
DATIA’s 5th Annual Conference and Exposition – “Strengthening the Industry With the Three R’s – Responsibility, Reliability, Regulatory Compliance” - will be the drug and alcohol testing industry’s biggest event of the year by far, providing attendees insight, information, and advocacy on issues that impact providers of drug and alcohol testing services. This year’s annual conference will be held May 31-June 2, 2001 at the Wigwam Resort in sunny Phoenix, Arizona.

The 5th Annual Conference agenda has been designed to motivate and provide concrete strategies to enable attendees to strengthen the industry through their responsibility, reliability, and regulatory compliance. Foremost among these issues are new federal regulations and guidelines that have a major effect on how workplace drug and alcohol testing is performed. The effects of new technologies and testing methodologies are part of this pending change, and will also be a focus of the conference agenda.

Top-level speakers from Federal Agencies and the industry will address the conference and interact with attendees to discuss the impact of these changes to drug and alcohol testing policy. DATIA conference speakers include Mary Bernstein from the Department of Transportation, one of several top officials from DOT that will provide attendees with an in-depth assessment of the changes in the newly released DOT CFR 49 Part 40. Attendees will be briefed on what they need to do to ensure compliance with the new regulations.

Jean Cooper of the Food and Drug Administration, Center for Devices and Radiological Health, will address FDA Regulation of Workplace and Over the Counter Drug and Alcohol Testing. Recent FDA decisions on the regulation

of workplace drugs of abuse and alcohol tests and the basis for the decisions will be discussed by the center’s Chief of Toxicology.

Walter Vogl from the Substance Abuse and Mental Health Services Administration will discuss DHHS Mandatory Guidelines and look at the future of drug testing. This presentation will provide an in-depth review of the draft Mandatory Guidelines for Federal Workplace Drug Testing Programs and how they will impact drug and alcohol testing. The incorporation of alternative specimens and point of collection testing will be discussed as it relates to the impact this will have on the industry.

In addition, Elena Carr from the US Dept. of Labor, Office of the Asst. Sec. for Policy and Bernie McCann of the Office of National Drug Control Policy will review how current federal agency programs, initiatives, and proposed legislation, regulations, and court rulings may impact drug free workplace programs. The speakers will suggest how businesses might position themselves to take advantage of the potential for future opportunities to expand service delivery to new markets.
As a drug and alcohol-testing provider, this is the one conference that can’t be missed. Don’t let this opportunity to meet with key legislative and regulatory officials, industry experts, and leaders in the advancement of drug and alcohol testing pass you by. We’re certain that every attendee of DATIA’s 5th Annual Conference and Exposition will have a positive learning experience and take with them concrete information that can immediately be applied to their specific operation. We look forward to seeing you at our celebration in Phoenix.

To learn more about DATIA’s 5th Annual Conference visit www.datia.org or call (800) 355-1257. Look for your DATIA Conference brochure and agenda in the mail in early January 2001.

 


FDA Says Screening Tests Could Require OTC Approval

The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health Advisory Committee met on November 13, 2000 and November 14, 2000 to discuss its proposal on guidelines for premarket submissions of over the counter (OTC) screening tests for drugs of abuse. The FDA’s proposal will have a significant impact on the industry.

The main issue of concern for the drug and alcohol testing industry is that screening tests used for workplace, criminal justice, school, and sports drug testing programs will be required to have OTC approval, a major new requirement with cost implications. Currently, when manufacturers apply for FDA approval of a screening test, it is the FDA’s Premarket Clearance for commercial distribution that they are seeking. This approval by FDA essentially indicates that the product is safe and effective when used as it is intended. OTC

 

approval, however, entails an entirely different approval process. The policies and procedures regarding OTC approval are significantly more comprehensive, lengthy, and expensive.

In addition, to receive OTC approval, each test kit must include a fee for and directions on how to send presumptive positives to a laboratory for confirmation. While DATIA has consistently been in favor of laboratory confirmations of presumptive positives, the effect of including a fee for this confirmation in the price of all test kits will substantially increase the cost of on-site test kits.

In early December, DATIA asked its members to complete a survey in order to determine how the membership views this important proposal. Results of the survey will be made available on DATIA’s website at www.datia.org in early January 2001 along with our comments to the FDA regarding this proposal.

HHS Issues Draft 3 of Mandatory Guidelines for Federal Drug Testing Programs

At the December 5, 2000 meeting of the Drug Testing Advisory Board (DTAB), the third draft of HHS’ Mandatory Guidelines for Federal Drug Testing Programs was introduced. This draft of the guidelines contained some significant changes, however, the majority of the changes served as clarifications.

A major change to the guidelines is the listing of preferred specimens for pre-employment, random, reasonable suspicion, post accident, return to duty, and follow-up testing. Hair was removed as a primary specimen for random testing, but was included as an alternate specimen to use if the donor is unable to provide a urine or oral fluid specimen.

Oral fluid was removed as a primary specimen type for pre-employment, return to duty, and follow-up testing, but was included as an alternate specimen for return to duty and follow-up testing if the donor is unable to provide a hair or sweat sample. Finally, urine was removed as a primary specimen type for return to duty and follow-up testing, but was included as an alternate specimen type to obtain if the donor is unable to provide a hair or sweat sample.

 

These significant changes are due to the drug detection windows that each specimen type provides. While all specimens will detect the drugs being tested for, drugs used over a month ago still can be detected in hair while drugs used a week ago cannot be detected in oral fluids. On the other end, drugs used an hour ago can be detected in oral fluids but cannot be detected in hair or sweat. Each specimen type has instances where it is a more appropriate specimen, and HHS has tried to convey this in its third draft of the guidelines.

The next step for the guidelines is for the working groups involved to meet and discuss some of the more technical and scientific aspects of the guidelines such as cutoff levels, cross reactivity, and when to use which type of specimen, to create a proposed rule that can be entered into the official process for public comment and ultimately approval. DATIA will keep you informed as to the next step that is taken by HHS concerning the Mandatory Guidelines for Federal Drug Testing Programs.

HHS Continues Lab Inspections

The Department of Health and Human Services (HHS) reported on December 5, 2000 that its inspection of all HHS Certified Laboratories is nearing a close. HHS indicated that it has been pleased with the inspection thus far, that any infractions found have been addressed with the laboratories, and that those laboratories will be required to report to HHS regarding the corrective action taken by the laboratories.

HHS indicated, however, that there are some tests that were initially reported as “substituted” that will be cancelled as a result of the inspections. As was stated in previous articles, there have been no instances found where there was an error in the validity tests performed by the laboratories; rather the errors occurred in the actual reporting of these results. HHS is in the process of developing a standardized letter that will be used to inform the laboratory, Medical Review Officer (MRO), and employer of a changed test result.

 

In addition, they will work with the MRO and employer to determine what action was taken with the employee as a result of the initial “substituted” test result. This action will need to be reversed, as the initial result was incorrect. DOT officials indicated that approximately 250-300 tests will be canceled.
HHS and DOT are to be commended for taking the high road on this issue. To alleviate similar problems in the future, HHS has indicated that future guidance will be officially published in the Federal Register, will be mandatory, and will contain a date by which new policies and procedures in the guidance need to be implemented. DATIA will keep you informed as new information is made public concerning the HHS Certified Laboratory inspections.

CA Implements Proposition 36 for Drug Treatment

California, which jails more drug users per capita than any other state, now must quickly change course and implement the most ambitious drug treatment program in U.S. history.

Voters recently passed Proposition 36, the ballot measure that mandates treatment over incarceration for most people convicted of drug possession. Proposition 36 requires that first- and second-offense drug violators be sent to drug treatment programs instead of facing trial and possible incarceration. The measure makes $60 million available immediately to expand treatment programs and adds an additional $120 million each year afterward. It prohibits drug testing and also bars sending offenders to jail as soon as they violate probation for a drug offense.

 

California's program likely will cost more than the $120 million a year allocated by Proposition 36. But projections say much of the cost will be offset because treatment is cheaper than building and operating prisons.

While Arizona can serve as an example, California's statewide change in direction is of much greater magnitude. Arizona had to find just 4,000 new treatment slots to handle about 6,000 offenders each year. California will have six times as many offenders, and its existing community treatment programs already have long waiting lists.

For the latest news on Proposition 36, visit www.drugtestingnews.com for up-to-date coverage.

DATIA Offers Comprehensive Training on New
Part 40

Since the Department of Transportation released the final version of CFR 49 Part 40, DATIA has been hard at work comparing the final regulations to the December 1999 proposed regulations and the regulations currently in effect. As the industry expected, there are many changes. These changes mean that much needs to be done by service providers before August 1, 2001 in order to comply with the rule.

DATIA will begin training on the new regulations at its first training courses in 2001, to be held on February 9, 2001 in Houston, TX.

DATIA’s Certified Professional Collector Trainer™ (CPCT™) Course will offer comprehensive instruction on the many new requirements for specimen collectors. Specifically, in the final CFR 49 Part 40 one of the requirements to be a trainer of other collectors is successful completion of a “Train the Trainer” course. DATIA’s course is the only such DOT reviewed course. The course will not only provide detailed information on the new collection requirements, but will also provide comprehensive education on how to conduct training of fellow collectors so that they are allowed to perform DOT specimen collections.


Some of the most significant changes in the new regulations concern the administration of drug and alcohol testing programs. How results are transmitted, what reports are sent, ensuring compliance by contracted service providers, and Public Interest Exclusions are just a few areas where service providers will need to learn new information and ways of managing their program. DATIA’s DOT reviewed Drug and Alcohol Testing Program Management Seminar, part of the Nationally Accredited for Administration of Drug and Alcohol Testing Programs (NAADATP) program, will focus on these areas to provide Consortia/Third part Administrators the tools needed to ensure that both their company and their client companies are compliant.

DATIA’s courses have continually sold out in the past and the courses in Houston are already filling up fast, so we encourage your early registration. Complete course information and agendas can be found at www.datia.org or contact DATIA at 800-355-1257 or info@datia.org if you have any questions.

 

 
 

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