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(a) A laboratory that does not maintain its HHS certification must: (1) Stop testing federally regulated specimens; (2) Ensure the security of federally regulated specimens and records throughout the required storage period described in Sections 11.20, 11.21, and 14.7; (3) Ensure access to federally regulated specimens and records in accordance with Sections 11.23 and 11.24 and Subpart P; and. 19. . Section 13.6 describes what an MRO must do when the collector reports that a donor did not provide a sufficient amount of hair for a drug test. Your Guide to Addiction Recovery & Relapse, The potential for abuse, whether actual or relative, Scientific evidence about the drug’s pharmacologic effects, The history of the drug and any information about patterns of abuse, How likely the drug is to cause either physical or psychological dependence, If the substance is part of the process to make another controlled drug. National Labor Relations Act (NLRA) of 1935 – The NLRA concerns employees that are in a union. To avoid prohibiting use of scientifically supportable hair biomarker or adulterant tests that may become available, the Department is authorizing specimen validity testing upon request of the Medical Review Officer as described in Sections 3.1 and 3.5. (c) The collector instructs the donor to initial the tamper-evident labels/seals on each specimen envelope. Forensic Sci Int. Provide social, health, and other services This pilot PT program was established to determine if it was possible to prepare stable and accurate hair PT samples, and to develop criteria for the PT program. are not part of the published document itself. Biology of hair and nails. Means the HHS-certified laboratory which has been notified of its suspension or proposed revocation of its certification to perform testing and has requested an informal review thereof. The donor must be allowed privacy while the collector obtains the hair specimen. 27, 545-551. An HHS-certified laboratory may group analytes for initial testing as shown in the table in Section 3.4 (i.e., use a single test for two or more analytes that are in the same drug class and have the same initial test cutoff), or may use multiple tests. 115- 391). Oregon's new drug decriminalization law is being heralded as a first-of-its-kind experiment, but it won't apply to all land within the state. All nationally recognized entities or subspecialty boards which seek approval by the Secretary to certify physicians as MROs for federal workplace drug testing programs must submit their qualifications, a sample examination, and other necessary supporting examination materials (e.g., answers, previous examination statistics or other background examination information, if requested). An immunoassay manufacturer may incur costs if they choose to alter their existing product and resubmit the immunoassay for Food and Drug Administration (FDA) clearance. . (8) Number of specimens rejected for testing because of an uncorrected flaw; (9) Number of specimens tested positive by each initial drug test; (10) Number of specimens reported positive; (11) Number of specimens reported positive for each drug and drug metabolite; (12) Number of specimens reported adulterated; (13) Number of specimens reported substituted; and. It is not an official legal edition of the Federal 35. The collector must remove the gloves from the package in the presence of the donor. include documents scheduled for later issues, at the request (4) Follow the HHS suspension and revocation procedures when imposed by the Secretary, follow the HHS procedures in Subpart P that will be used for all actions associated with the suspension and/or revocation of HHS certification. Schaffer M, Cheng C, Chao O, Hill V, Matsui P. 2016. (b) The Secretary shall consider the following factors in determining whether revocation is necessary: (1) Unsatisfactory performance in analyzing and reporting the results of drug tests (e.g., an HHS-certified laboratory reporting a false positive result for an employee's drug test); (2) Unsatisfactory participation in performance testing or inspections; (3) A material violation of a certification standard, contract term, or other condition imposed on the HHS-certified laboratory by a federal agency using the laboratory's services; (4) Conviction for any criminal offense committed as an incident to operation of the HHS-certified laboratory; or. 84:25-35. The time course of drugs and metabolites differs between hair, urine, and oral fluid, resulting in some differences in analytes and detection times. documents in the last year, 28 In October 2020, the United States will mark the 50th ... begin refocusing federal drug policies, the legislation shifts the authority for classifying and regulating ... most harmed by drug law enforcement as well as people who use drugs, to: i. As noted previously in this preamble, because the MRO does not report positive hair test results to the federal agency without corroborating evidence (i.e., donor admission of illicit drug use), split specimens are not tested to reconfirm positive hair test results. If residues are found above that level, the commodity will be subject to seizure. Section 14.3 How does an HHS-certified laboratory test a split (B) hair specimen when the primary (A) specimen was reported substituted? 2016) and Thompson v. Civil Service Com'n, 90 Mass.App.Ct. Open for Comment, Economic Sanctions & Foreign Assets Control, Asylum Interview Interpreter Requirements, National Oceanic and Atmospheric Administration, White House Initiative on Advancing Educational Equity, Excellence, and Economic Opportunity for Hispanics, Mandatory Guidelines for Federal Workplace Drug Testing Programs. Decontamination. Under federal law, marijuana is treated like every other controlled substance, such as cocaine and heroin. This is in addition to the 1,788,809 hours currently approved by OMB under control number 0930-0158 for urine testing under the current Guidelines. Lockyer also underscored the role of local law enforcement in upholding state, not federal, law. A number of units of an item (e.g., reagents, quality control material) manufactured from the same starting materials within a specified period of time for which the manufacturer ensures that the items have essentially the same performance characteristics and expiration date. The notice requested comments from the public and industry stakeholders regarding a variety of hair testing issues (e.g., specimens, collection, specimen preparation, analytes/cutoffs, specimen validity, and testing methods). Int J Toxicol. The Department committed to monitoring developments in alternative specimen testing and has continued to do so since 2008. Idaho: All employers can conduct drug testing on applicants. Transmissions of the reports must ensure confidentiality. Aliquot. Put Your Trust In Us — Contact Wolfe & Stec, Ltd. for a Free Consultation About 2020 Illinois Drug Laws and Offenses. The HMG allow, but do not require, other specimen validity testing for hair. documents in the last year, 482 Section 16.13 What administrative records are maintained? Therefore, Kentucky laws, since they are more stringent, must be followed. There is no requirement for federal agencies to use hair as part of their drug testing program. This section is analogous to the corresponding section in the UrMG with differences, where applicable, for hair specimen reports. Substance Abuse and Mental Health Services Administration (SAMHSA), HHS. Likewise, there will be minimal costs associated with changing initial testing to include MDA and MDMA since current immunoassays can be adapted to test for these analytes. An updated and complete list of the schedules is published annually in Title 21 Code of Federal Regulations (C.F.R.) This information is current as of April 2, 2020. (d) The MRO must not disclose numerical values of drug test results to the agency. The collector must indicate that the specimen is a blind sample on the MRO copy where a donor would normally provide a signature. Title: The Mandatory Guidelines for Federal Workplace Drug Testing Programs using Hair. Sections 11.15 and 11.16 cover validation and quality control requirements for the confirmatory tests. The Department is specifically requesting comments including supporting data from the scientific literature on additional analytes (e.g., metabolites) that may be tested on a case-by-case basis or routinely upon MRO request. Donor. A unique metabolite does not occur as a contaminant in licit and illicit drug products and is not produced from the drug as an artifact and only results from biotransformation following drug use. 2014. The following privacy requirements apply when a donor is providing a hair specimen: (a) Only authorized personnel and the donor may be present in the restricted access area where the collection takes place. The Secretary has the authority to issue directives to any HHS-certified laboratory, including suspending the use of certain analytical procedures when necessary to protect the integrity of the testing process; ordering any HHS-certified laboratory to undertake corrective actions to respond to material deficiencies identified by an inspection or through performance testing; ordering any HHS-certified laboratory to send specimens or specimen aliquots to another HHS-certified laboratory for retesting when necessary to ensure the accuracy of testing under these Guidelines; ordering the review of results for specimens tested under the Guidelines for private sector clients to the extent necessary to ensure the full reliability of drug testing for federal agencies; and ordering any other action necessary to address deficiencies in drug testing, analysis, specimen collection, chain of custody, reporting of results, or any other aspect of the certification program. In the event a federal agency adopts hair testing and the donor is unable to provide a hair specimen for faith-based or medical reasons, or due to an insufficient amount or length of hair, the federal agency would be required to collect an alternate specimen. In the case of communications sent by regular mail, the date of receipt will be considered 3 days after the date of mailing. We've made it easy for you. Hair color is controlled, in part, by the biochemistry of two major groups of melanin pigments. (b) A confirmatory drug test must be validated before it can be used to test federally regulated specimens. In addition to any other authority specified in these procedures, the reviewing official and the presiding official, with respect to those authorities involving the oral presentation, shall have the authority to issue orders; examine witnesses; take all steps necessary for the conduct of an orderly hearing; rule on requests and motions; grant extensions of time for good reasons; dismiss for failure to meet deadlines or other requirements; order the parties to submit relevant information or witnesses; remand a case for further action by the respondent; waive or modify these procedures in a specific case, usually with notice to the parties; reconsider a decision of the reviewing official where a party promptly alleges a clear error of fact or law; and to take any other action necessary to resolve disputes in accordance with the objectives of these procedures. Ultimately, the commission found that the hair testing methodology was not sufficiently reliable to be the sole basis for an officer's termination, concluding that “[a] reported positive test result . Split Specimen Collection (for Hair). This empowering volume examines several key points, including: Whether marijuana can relieve a variety of symptoms, including pain, muscle spasticity, nausea, and appetite loss. This pilot PT program is described in the History and Proposed Changes to the HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs section below. Section 11.19 describes in detail, requirements for how a certified laboratory reports test results to the MRO for hair specimens. Washington — Although some state drug laws recently have been revised to legalize marijuana, the Substance Abuse and Mental Health Services Administration is reminding officials that the federal government’s Drug-Free Workplace Program has not changed. (4) Fail or decline to participate in an alternate specimen collection (e.g., urine, oral fluid) as directed by the federal agency or collector (i.e., as described in Section 8.5); (5) Fail to cooperate with any part of the testing process (e.g., disrupt the collection process; refuse to allow the collector to collect a sufficient amount of hair; fail to provide a split specimen); (6) Bring materials to the collection site for the purpose of adulterating or substituting the specimen; (7) Attempt to adulterate or substitute the specimen; or. 552a and 48 CFR 24.101-24.104, all agency contracts with laboratories, collectors, and MROs must require that they comply with the Privacy Act, 5 U.S.C. Unless otherwise provided by the Secretary in the notice of revocation under Section 9.15 or the reviewing official's decision under Section 16.9(e) or 16.14(a), a laboratory which has had its certification revoked may reapply for HHS certification as an applicant laboratory. These efforts identified specific scientific, administrative, and procedural requirements necessary for a comprehensive federal workplace drug testing program that included alternative specimens and technologies. PENALTIES . Kronstrand R, Forstberg-Peterson S, Kagedal B, Ahlner J, Larson G. 1999. These issues may confound the results and interpretation of hair tests as explained in more detail below. The Substance Abuse and Mental Health Services Administration (SAMHSA) subsequently revised the Guidelines on June 9, 1994 [59 FR 29908], September 30, 1997 [62 FR 51118], November 13, 1998 [63 FR 63483], April 13, 2004 [69 FR 19644], and November 25, 2008 [73 FR 71858]. J Anal Toxicol. A number of laboratory animal studies indicate that some drugs are differentially incorporated into hair based on color. 7. J Anal Toxicol. Section 8.6 What procedure is used when the donor is unable to provide a hair specimen? However, the longer window of detection makes hair an appropriate choice for pre-employment and random. Because the Mandatory Guidelines govern standards applicable to the management of federal agency personnel, there should be little, if any, direct effect on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. As noted above, the purposes of the Hair Pilot PT Program were to determine if it was possible to prepare stable and accurate hair PT samples, and to develop criteria for the PT program. Prior to being allowed to test regulated hair specimens, laboratories must be certified by the Department through the NLCP. A proposed revocation must be effective 30 days after written notice is given or, if review is requested, upon the reviewing official's decision to uphold the proposed revocation. DOT OFFICE OF DRUG AND ALCOHOL POLICY AND COMPLIANCE NOTICE. Federal Controlled Substances Act and its implementing regulations as they pertain to the pharmacy profession. Section 11.25 What types of relationships are prohibited between an HHS-certified laboratory and an MRO? (a) An individual may be selected as an inspector for the Secretary if they satisfy the following criteria: (1) Has experience and an educational background similar to that required for either a responsible person or a certifying scientist for an HHS-certified laboratory as described in Subpart K; (2) Has read and thoroughly understands the policies and requirements contained in these Guidelines and in other guidance consistent with these Guidelines provided by the Secretary; (3) Submits a resume and documentation of qualifications to HHS; (5) Performs acceptably as an inspector on an inspection of an HHS-certified laboratory. In October 2020, the United States will mark the 50th ... begin refocusing federal drug policies, the legislation shifts the authority for classifying and regulating ... most harmed by drug law enforcement as well as people who use drugs, to: i. Schedule I drugs have a high potential for misuse, no accepted medical treatment in the United States, and a lack of safety even if they were to be supervised by a medical professional. 14 Wright J, Kenneally M, Edwards J, Walker S. 2017. Section 7.1 describes the collection materials that must be used to collect a hair specimen. (a) The donor may request, verbally or in writing, through the MRO that the split (B) hair specimen be tested at a different (i.e., second) HHS-certified laboratory when the primary (A) specimen was determined by the MRO to be adulterated or substituted. 2015. As noted in Section 11.9, the collector forwards the alternate authorized specimen collected at the same time as the hair specimen to a laboratory that is certified by HHS for that specimen type. March 23, 2020. Provide social, health, and other services Accessioner. All tests must be properly validated and include appropriate quality control samples in accordance with these Guidelines. (b) A federal agency applicant or employee must not collect his or her own drug testing specimen. Identification of a unique drug metabolite would distinguish drug use from environmental contamination as long as strict criteria for defining a unique metabolite are established.11 The proposed HMG define a unique metabolite as “a drug metabolite present in a hair specimen only as a result of biotransformation following drug use” and which “does not occur as a contaminant in licit and illicit drug products and is not produced from the drug as an artifact.”. If an HHS-certified laboratory reports a result for a blind sample that is inconsistent with the expected result (e.g., a laboratory reports a negative result for a blind sample that was supposed to be positive, a laboratory reports a positive result for a blind sample that was supposed to be negative): (a) The MRO must contact the laboratory and attempt to determine if the laboratory made an error during the testing or reporting of the sample; (b) The MRO must contact the blind sample supplier and attempt to determine if the supplier made an error during the preparation or transfer of the sample; (c) The MRO must contact the collector and determine if the collector made an error when preparing the blind sample for transfer to the HHS-certified laboratory; (d) If there is no obvious reason for the inconsistent result, the MRO must notify both the federal agency for which the blind sample was submitted and the Secretary; and. The authors suggest that ethnic groups are significantly different irrespective of testing procedure. 09/17/2021, 338 What are some of the known issues with drug testing using hair? If single-use items are used, the collector is not required to clean the item before use assuming such use is the first use of the item. (a) A collector who has been trained to collect hair specimens in accordance with these Guidelines. Biochemical approach on the conservation of drug molecules during hair fiber formation. All collection materials that come into contact with the hair Start Printed Page 56118must not substantially affect the composition of drug and/or drug metabolites in the specimen. This notice shall state the following: (1) The reasons for the suspension or proposed revocation; (2) The terms of the suspension or proposed revocation; and. Note the collection of information on the Federal Chain of Custody Form as required by the Mandatory Guidelines are discussed below under information collection and record keeping and are a separate submission and approval by the Office of Management and Budget. As noted under Executive Orders 13563 and 12866 in the Regulatory Impact and Notices section of this Notice, the Department does not find these proposed mandatory guidelines to be a significant burden for federal agencies or incur a significant cost. A copy of the request for review must also be sent to the respondent. Section 4.3 What are the requirements to be a collector? (d) The collector asks the donor whether they have false hair (i.e., artificial or natural hair that is not their own such as a wig, weave, or extensions). The presiding official may hold a prehearing conference in accordance with Section 16.8(c) and will conduct the oral presentation in accordance with the procedures of Sections 16.8(e), (f), and (g). In: Jolles P, Zahn Start Printed Page 56127H, Hoecker H, editors. Title 21-FOOD AND DRUGS is composed of nine volumes. The parts in these volumes are arranged in the following order: Parts 1-99, 100-169, 170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300 to end. 242:103-110. Senate Democrats Unveil Sweeping Federal Marijuana Legalization Proposal. Section 5.1 Where can a collection for a drug test take place? Section 11.9 How must an HHS-certified laboratory process an alternate specimen that was collected at the same time as a hair specimen? of the issuing agency. Identification of reaction products of methamphetamine and hydrogen peroxide in hair dye and decolorant treatments by high performance liquid chromatography/mass spectrometry. The OFR/GPO partnership is committed to presenting accurate and reliable The appellant must submit this request in writing to the reviewing official within 3 days of the date the HHS-certified laboratory received notice of the suspension. Although the DEA has relaxed Federal controlled substances laws, Kentucky Drug Enforcement and Professional Practices Branch of the Kentucky Office of Inspector General in the Cabinet for Health and Family Services has not. Approval will be based on an objective review of qualifications that include a copy of the MRO applicant application form, documentation that the continuing education courses are accredited by a professional organization, and the delivery method and content of the examination. (a) An individual may serve as a collector if they fulfill the following conditions: (1) Is knowledgeable about the collection procedure described in these Guidelines; (2) Is knowledgeable about any guidance provided by the federal agency's Drug-free Workplace Program and additional information provided by the Secretary relating to these Guidelines; (3) Is trained and qualified to collect a hair specimen. The presiding official shall have the oral presentation transcribed and the transcript shall be Start Printed Page 56150made a part of the record. Enabling collection of another specimen without delay should facilitate the pre-employment process and may help reduce attempts to subvert the drug test. If the dispute has not been resolved, the review procedures will begin at the point at which they were interrupted by the abeyance agreement with such modifications to the procedures as the reviewing official deems appropriate. 41. (b) HHS-certified laboratories must use chain of custody procedures to document the handling and transfer of aliquots throughout the testing process until final disposal. Based on information from current commercial hair testing laboratories, once hair testing is implemented, the average cost per specimen will range from $40.00 to $45.00. However, comments provided by the public on the subject of potential added burden could be useful to federal agencies deciding whether to test hair in addition to other specimen types in their federal workplace drug testing programs. However, it is essential to familiarize yourself with the various state laws. National Conference of State Legislatures. The Department proposes that hair tests be used in the pre-employment and random drug testing contexts only. A recent prepublication article by researchers from the University of Arkansas was provided to the Department for review. 12564, establishes the scientific and technical guidelines for federal workplace drug testing programs and establishes standards for certification of laboratories engaged in drug testing for federal agencies. Agents learned that they were traveling to the Dallas/Ft. If a memorandum for the record cannot be obtained, the laboratory reports a rejected for testing result to the MRO and the MRO cancels the test. Only official editions of the Thus, the First Circuit characterized “a follow-up series of random urinalysis tests” for officers who tested positive using hair as being just “as accurate as the hair test alone at detecting the non-presence of cocaine metabolites while simultaneously yielding a smaller share of false positives in a manner that would have reduced the disparate impact of the hair test.” Id. documents in the last year, 748 The measure, which was approved, Formation and structure of human hair. If the donor refuses to sign the certification statement, the collector notes the refusal on the Federal CCF and continues with the collection process. Anal Bioanal Chem. This includes the requirement for a laboratory to use the confirmatory test cutoff as the cutoff for an alternate technology initial test that is specific for THCA. Grabenauer M, Bynum N, Moore K, White R, Mitchell J, Hayes E, Flegel R. 2018. A federal agency may only collect a hair specimen for federal agency pre-employment and random testing purposes, and may not use hair specimens for reasonable suspicion/cause, post accident, return to duty, or follow-up testing purposes (i.e., for purposes other than pre-employment or random testing). A specimen with physical or chemical characteristics that are not consistent with those observed in human hair. Hair may be collected in various settings and may not necessarily require a specialized collection facility, but if a second authorized specimen is collected at the same time then the collection facility must meet the requirements for a collection facility for the alternate specimen. Even if NRC and DOT do not implement hair testing, the benefits to federal workplace testing programs could be a cost savings, which would recur on annual basis. Specimen collection materials must be single-use, with the exception of scissors and/or clips which may be either single-use or reusable (as described in item 2 below). Section 9.13 What factors are considered in determining whether revocation of a laboratory's HHS certification is necessary? According to a new fact-sheet issued by the Commission, just over 1,000 people were sentenced federally in 2020 for violating marijuana trafficking laws. Co-conspirator Daniel Walker Gabehart, age 49, also of Council Bluffs, was sentenced by Judge Ebinger on December 16, 2020. As of this printing, the federal government claims that marijuana is not medicine and in Gonzales v. Raich (2005), the United States Supreme Court held that the federal government has the constitutional authority to prohibit marijuana for all purposes. better and aid in comparing the online edition to the print edition. SAMHSA will post all comments before the close of the comment period on the following website: http://www.regulations.gov. The functions of the National Laboratory Certification Program include maintaining laboratory inspection and PT programs as described in these Guidelines. 16. de La Torre R, Civit E, Svaizer F, Lotti A, Gottardi M, Miozzo M. 2010. (3) Training and experience in reviewing and reporting forensic test results and maintaining chain of custody, and an understanding of appropriate remedial actions in response to problems that may arise. Thus, federal law enforcement officials may prosecute medical marijuana patients, even if they grow their own medicine and even if they reside in a state where medical marijuana use is protected under state law. ( not substituted ) and ( M ) below concentration at which the analyte ( e.g. urine... 16.9 are there expedited procedures for development of the United states communicates information on procedures identify. 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