ML19338D255

Comment (017) of William Gross on Behalf of the Nuclear Energy Institute Regarding PR-026 - Fitness for Duty Drug Testing Requirements

ML19338D255
Person / Time
Site:	Nuclear Energy Institute
Issue date:	12/02/2019
From:	Gross W Nuclear Energy Institute
To:	NRC/SECY/RAS
SECY/RAS
References
84FR48750 00017, DG-5040, NRC-2009-0225, PR-026
Download: ML19338D255 (18)

Text

Page 1 of 1 PR-026 17 84FR48750 As of: 12/3/19 9:44 AM Received: December 02, 2019 PUBLIC SUBMISSION Status: Pending_Post Tracking No. 1k3-9dn6-c0al Comments Due: December 02, 2019 Submission Type: Web Docket: NRC-2009-0225 Fitness-for-Duty Drug Testing Program Requirements Comment On: NRC-2009-0225-0009 Fitness for Duty Drug Testing Requirements; Request for Comment on Proposed Rule and Draft Regulatory Guide Document: NRC-2009-0225-DRAFT-0043 Comment on FR Doc # 2019-18491 Submitter Information Name: William Gross Address:

1201 F St., NW Suite 1100 Washington, DC, 20004 Email: wrg@nei.org General Comment Industry Comments on Part 26 Proposed Rulemaking, "Fitness for Duty Drug Testing Requirements" noticed in the Federal Register, Vol. 84, No. 179, Dated September 16, 2019, and Draft Regulatory Guide DG-5040, "Urine Specimen Collection and Test Results Review Under 10 CFR Part 26, "Fitness for Duty Programs", dated August 2019, Docket ID NRC-2009-0225 Attachments Part 26 Proposed Rulemaking and DG 5040 NRC Submittal Comment Letter https://www.fdms.gov/fdms/getcontent?objectId=09000064841d9bbd&format=xml&showorig=false 12/03/2019

WILLIAM R. GROSS Director, Incident Preparedness Facility Security Officer 1201 F Street NW, Suite 1100 Washington, DC 20004 P: 202.739.8123 wrg@nei.org nei.org December 02, 2019 Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 ATTN: Rulemaking and Adjudications Staff Submitted via Regulations.gov

Subject:

Industry Comments on Part 26 Proposed Rulemaking, Fitness for Duty Drug Testing Requirements noticed in the Federal Register, Vol. 84, No. 179, Dated September 16, 2019, and Draft Regulatory Guide DG-5040, Urine Specimen Collection and Test Results Review Under 10 CFR Part 26, Fitness for Duty Programs, dated August 2019, Docket ID NRC-2009-0225 Project Number: 689 On behalf of the Nuclear Energy Institutes (NEI)1 members (hereinafter referred to as industry), we provide the attached comments on Part 26 Proposed Rulemaking, Fitness for Duty Drug Testing Requirements noticed in the Federal Register, Vol. 84, No. 179, Dated September 16, 2019, and Draft Regulatory Guide DG-5040, Urine Specimen Collection and Test Results Review Under 10 CFR Part 26, Fitness for Duty Programs, dated August 2019, for consideration by the NRC staff. The proposed rule and DG 5040 closely align the NRCs drug testing requirements with the updates made to the U.S. Department of Health and Human Services Mandatory Guidelines for Federal Workplace Drug Testing Programs issued in 2008. The proposed rule and DG 5040 would also incorporate lessons learned from implementation of the NRCs current FFD regulations and would enhance the ability of NRC licensees and other entities to identify individuals using illegal drugs, misusing legal drugs, or attempting to subvert the drug testing process.

1 The Nuclear Energy Institute (NEI) is responsible for establishing unified policy on behalf of its members relating to matters affecting the nuclear energy industry, including the regulatory aspects of generic operational and technical issues. NEIs members include entities licensed to operate commercial nuclear power plants in the United States, nuclear plant designers, major architect and engineering firms, fuel cycle facilities, nuclear materials licensees, and other organizations involved in the nuclear energy industry.

Rulemakings and Adjudications Staff December 2, 2019 Page 2 The industry is generally in support of the NRC proposed rule and believes additional changes should also be considered for inclusion into the Part 26 rulemaking, to enhance efficiencies while maintaining the continued reliability of the Fitness-for-Duty program. In summary, the industry recommends that NRC:

• Eliminate the need for blind performance testing requirements similar to DOTs proposed changes in Federal Register Vol. 82, No. 217, November 13, 2017.

• Adopt the HHS Guidelines for oral fluid testing without the need to submit an exemption or awaiting future rulemaking.

• Establish a streamlined process for industry adoption of future HHS Guideline issuance without awaiting future rulemaking.

More details of these proposals are contained in the attachments. We appreciate the opportunities that have been provided to interact with the staff and to provide comments on the revisions.

If you have any questions or require additional information, please contact Lisa Hogg, at (202) 739-8121 or lbh@nei.org, or me.

Sincerely, William R. Gross Attachments:

1) Industry Comments on Part 26 Proposed Rulemaking, Fitness for Duty Drug Testing Requirements noticed in the Federal Register, Vol. 84, No. 179, Dated September 16, 2019,

2) Industry Comments on Draft Regulatory Guide DG-5040, Urine Specimen Collection and Test Results Review Under 10 CFR Part 26, Fitness for Duty Programs, dated August 2019 c: Shana Helton, Director, DPCP NRC Document Control Desk

Attachment 1 Industry Comments on Part 26, Fitness for Duty Drug Testing Requirements, Proposed Rulemaking Response to specific requests for comment from section V. starting on page 48770 from Federal Register, volume 84, No. 179 dated Monday, September 16, 2019.

Comment Response

1. Alignment with HHS Guidelines There should be a streamlined process other than rulemaking to incorporate the drug panel for Fitness The NRC is seeking comment on additional provisions in 10 CFR part for Duty (FFD) drug testing for nuclear facilities upon 26 that are consistent with the HHS Guidelines and could be issuance of Department of Health and Human eliminated from 10 CFR part 26. Services (HHS) Guidelines.

2. Special Analyses Testing No. Special analyses testing will not provide additional value to the testing process for personnel in both The proposed rule includes new requirements in § 26.163(a)(2) for random and follow up pools. This would make it the special analyses testing of urine specimens for drugs and drug difficult to allow credit of random tests for follow up metabolites. The first would require special analyses testing of tests. However, it is reasonable to conduct special specimens with dilute validity test results when initial drug testing analyses testing for the first observed test.

identifies a drug or drug metabolite within 40 percent of the testing cutoff level. Currently, special analyses testing of dilute specimens is optional. The second new requirement would expand special analyses testing to specimens collected under direct observation as required by § 26.115(a)(1) through (a)(3) and new paragraph (a)(5).

The NRC is seeking comment on whether special analyses testing should also apply to the testing of individuals that already have tested positive on a 10 CFR part 26 test (i.e., denied unescorted access authorization by § 26.75(d) for a first or second drug testing positive result). Requiring special analyses testing in this case would add a level of assurance to follow-up testing required by § 26.69(b)(6), which is conducted to confirm continued abstinence from illegal drug use and/or the misuse of legal drugs.

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Attachment 1 Industry Comments on Part 26, Fitness for Duty Drug Testing Requirements, Proposed Rulemaking Comment Response

3. Provide Flexibility To Conduct Additional Specimen This may result in an inconsistent approach across Validity Tests the industry however, there should be a more streamlined process for adopting future updates to The NRC is seeking comment on whether § 26.161(h) should be the HHS Guidelines.

revised to provide a licensee or other entity with the option to conduct additional specimen validity tests and/ or to utilize lower cutoff levels if the HHS Guidelines are revised in the future to include such testing.

4. Effective Date of the Final Rule Once the rule is issued licensees will need to evaluate change management plan items to include The NRC is seeking comment on whether this implementation time procedures, union/lab contracts, computer systems, period is appropriate based on the proposed rule changes. training, etc. To fully and effectively implement the new program utilizing established processes, licensees will need approximately 12 months.

Clarify that during the transition period, any program may accept and rely on another programs FFD-related information as long as the information being shared is compliant with the sharing programs current Part 26 processes.

5. Direct Observation of Specimen Collection Oral Fluid Testing should be considered as an effective alternative testing method especially for The proposed rule retains the requirement for direct observation direct observations and for shy-bladder instances.

during the collection of a second sample when there are indications The rule should be stated such that the industry can of a subversion attempt during the initial collection. The NRC is adopt and implement the HHS guidelines for oral fluid seeking comment on whether there are any effective alternatives to testing within their programs without submitting exemptions or awaiting rulemaking.

direct observation that will assist in preventing subversion of the drug testing process.

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Attachment 1 Industry Comments on Part 26, Fitness for Duty Drug Testing Requirements, Proposed Rulemaking Comment Response

6. 2017 HHS GuidelinesNew Test Analytes Although testing costs would increase, NEI and its members believe there is a safety benefit to include On January 23, 2017, HHS issued its latest revision of the Mandatory hydrocodone, hydromorphone, oxycodone, and Guidelines for Federal Workplace Drug Testing Programs Using Urine oxymorphone test substances in the rule.

Specimens (82 FR 7920). Subpart C, Urine Drug and Specimen Validity Tests, of the 2017 HHS Guidelines was revised to include additional initial and confirmatory test analytes for certain opioids; specifically, hydrocodone, hydromorphone, oxycodone, and oxymorphone. The NRC is seeking comment on whether §§ 26.31(d)(1) and 26.405(d) should be revised to identify hydrocodone, hydromorphone, oxycodone, and oxymorphone test substances, and whether §§ 26.133 and 26.163(a)(1) and (b)(1) should be revised to require initial and confirmatory testing of these drugs at the cutoff levels recommended in the 2017 HHS Guidelines.

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Attachment 1 Industry Comments on Part 26, Fitness for Duty Drug Testing Requirements, Proposed Rulemaking Comment Response

7. Methylenedioxyethylamphetamine Although Ecstasy drugs have not been a prevalent issue in the industry, NEI and its members are in The 2008 HHS Guidelines adds methylenedioxyethylamphetamine favor of aligning with the 2017 HHS Guidelines.

(MDEA) as a confirmatory analyte to the drug testing panel in Section However, if blind specimen testing remains a 3.4. However, when the HHS revised the mandatory guidelines in requirement, consideration should be given to 2017, HHS removed MDEA from Section 3.4 stating that [t]he eliminate testing of drugs that are not prevalent issues in the industry.

Department has evaluated the comments and has removed MDEA from the Guidelines (i.e., MDEA is no longer included as an authorized drug in Section 3.4). The number of positive MDEA specimens reported by HHS certified laboratories (i.e., information provided to the Department through the NLCP) does not support testing all specimens for MDEA in federal workplace drug testing programs. (82 FR 7920, 7923; January 23, 2017). The NRC is not proposing to adopt the 2008 HHS Guidelines addition of MDEA as a confirmatory test analyte at this time. As a result, the NRC is also proposing to add MDA to the initial testing panel to fully align with the Ecstasy drugs testing panel in the 2017 guidelines. The NRC is seeking comment on these changes.

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Attachment 1 Industry Comments on Part 26, Fitness for Duty Drug Testing Requirements, Proposed Rulemaking Comments on proposed rulemaking.

Proposed Rule Section Comments Suggested Wording/Revision Subpart AAdministrative Provisions

§ 26.4 FFD program applicability to categories of individuals.

(g)(6) All persons monitoring a donor §26.31 only requires monitors to be Remove proposed (g)(6) from § 26.4 during the hydration process described in trained to perform the activity.

§ 26.109(b). Requiring monitors to be covered by the program is an unnecessary expansion that does not improve the effectiveness of the activity. Observers are not required to be Collectors subject to the FFD program and their role is more significant ensuring the proper collection of a specimen.

Requirements for the Hydration Monitor should be consistent with the requirements for an Observer.

Subpart AAdministrative Provisions

§ 26.5 Definitions.

Federal custody and control form Additional clarity is needed for the Recommend to revise definition to read:

(Federal CCF) means any HHS- following which has not expired and Federal custody and control form approved form, which has not expired, additional clarity is needed for the use (Federal CCF) means any HHS-approved that is published in the Federal Register of equivalent forms. or equivalent form, which has not and is used to document the collection, expired, that is published in the Federal custody, transport, and testing of a Register and is used to document the specimen. collection, custody, transport, and testing of a specimen. Expired custody 5

Attachment 1 Industry Comments on Part 26, Fitness for Duty Drug Testing Requirements, Proposed Rulemaking Proposed Rule Section Comments Suggested Wording/Revision and control forms may be used if covered by an active memorandum for the record.

Subpart AAdministrative Provisions

§ 26.5 Definitions.

Potentially disqualifying FFD information means information demonstrating that an individual has (1) Violated a licensee's or other entity's FFD policy; (2) Had authorization denied or terminated unfavorably under §§ 26.35(c)(2), 26.53(i), 26.63(d), 26.65(g),

26.67(c), 26.69(f), or 26.75(b) through (e);

(3) Used, sold, or possessed illegal Marijuana legalized by state law needs Recommend to revise language to read:

drugs; to be addressed. (3) Used, sold, or possessed illegal drugs (Including controlled substances (4) Abused legal drugs or alcohol; determined to be illegal under federal law, such as marijuana, but deemed (5) Subverted or attempted to subvert a legal under state law);

drug or alcohol testing program; (6) Refused to take a drug or alcohol test; (7) Been subjected to a plan for (7) is in direct conflict with (3) and (4) Recommend to revise language to read:

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Attachment 1 Industry Comments on Part 26, Fitness for Duty Drug Testing Requirements, Proposed Rulemaking Proposed Rule Section Comments Suggested Wording/Revision substance abuse treatment (except for above. (7) Been subjected to a plan for self-referral); or substance abuse treatment; or (8) Had legal action or employment action, as defined in this section, taken for alcohol or drug use.

Subpart AAdministrative Provisions

§ 26.5 Definitions.

Rejected for testing means the result Consider re-wording for clarity. Recommend to revise definition to read:

reported to the MRO by a licensee testing Rejected for testing means the result facility or HHS-certified laboratory when reported to the MRO by a licensee no tests can be performed on a testing facility or HHS-certified laboratory specimen. when a fatal flaw disqualifies a specimen or, any of the required testing cannot be performed on a specimen.

Subpart AAdministrative Provisions

§ 26.5 Definitions.

Substance abuse means the use, sale, or Consider including controlled Recommend to revise definition to read:

possession of illegal drugs, or the abuse substances, such as marijuana which Substance abuse means the use, sale, of prescription and over-the-counter has been legalized by some states to or possession of illegal drugs, or the drugs, or the abuse of alcohol. provide clarity. abuse of prescription and over-the-counter drugs, or controlled substances determined to be illegal under federal law, such as marijuana, but deemed legal under state law, or the abuse of alcohol.

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Attachment 1 Industry Comments on Part 26, Fitness for Duty Drug Testing Requirements, Proposed Rulemaking Proposed Rule Section Comments Suggested Wording/Revision Subpart BProgram Elements

§ 26.31 Drug and alcohol testing.

(d)(2)(v) Require that individuals who are Need to clarify availability of the Recommend to revise language to read:

off site when selected for testing, or who collector performing in a collector (d)(2)(v) Require that individuals who are on site and are not reasonably capacity. are off site when selected for testing, or available for testing when selected, shall who are on site and are not reasonably be tested at the earliest reasonable and available for testing when selected, shall practical opportunity when both the be tested at the earliest reasonable and donor and collectors are available to practical opportunity when collection collect specimens for testing and without personnel are scheduled to perform prior notification to the individual that he collections and the donor is available for or she has been selected for testing; testing and without prior notification to the donor that he or she has been selected for testing; Subpart ECollecting Specimens for Testing

§ 26.89 Preparing to collect specimens for testing.

(d) In order to promote the security of Clarity is needed (and in § 26.117(c)) Recommend to revise language to read:

specimens, avoid distraction of the on what constitutes a label versus a (d) In order to promote the security of collector, and ensure against any seal. § 26.117 refers to an specimens, avoid distraction of the confusion in the identification of identification label, as well as a collector, and ensure against any specimens, a collector shall conduct only tamper-evident seal. Verbiage needs confusion in the identification of one collection procedure at any given to completely align with other sub- specimens, a collector shall conduct only time, except as described in § section(s) to avoid future confusion or one collection procedure at any given 26.109(b)(1). The urine collection compliance issues. time, except as described in § procedure is complete when the urine 26.109(b)(1). The urine collection specimen container has been sealed with procedure is complete when the urine 8

Attachment 1 Industry Comments on Part 26, Fitness for Duty Drug Testing Requirements, Proposed Rulemaking Proposed Rule Section Comments Suggested Wording/Revision tamper-evident tape, the seal has been specimen container has been sealed with dated and initialed, and the Federal CCF a tamper-evident seal, the seal has been has been completed or when a refusal to dated and initialed, and the Federal CCF test has been determined under § has been completed or when a refusal to 26.107(d). test has been determined under § 26.107(d).

Subpart ECollecting Specimens for Testing

§ 26.109 Urine specimen quantity.

(b) If the quantity of urine in the first specimen provided by the donor is less than 30 mL, the collector shall take the following steps:

(1) The collector shall encourage the The need for the Hydration Monitor to Recommend to revise language in § donor to drink a reasonable amount of be a Collector is unnecessary and an 26.109(b)(1) to read:

liquid (normally, 8 ounces of water every administrative burden. Guidance and (1) The collector shall encourage the 30 minutes, but not to exceed a instruction can be provided similar to donor to drink a reasonable amount of maximum of 40 ounces over 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br />) that given when needed for an liquid (normally, 8 ounces of water every until the donor provides a specimen of at observed test when the observer is 30 minutes, but not to exceed a least 30 mL. Alternatively, as specified in not a FFD collector. maximum of 40 ounces over 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br />) the licensees or other entitys FFD until the donor provides a specimen of at program procedures, the collector may There is insufficient room on the CCF least 30 mL. Alternatively, as specified in assign responsibility for monitoring a to record the name of the hydration the licensees or other entitys FFD donor during the hydration process to monitor on the CCF and it is program procedures, the collector may another collector who meets the unnecessary. The CCF does not assign responsibility for monitoring a requirements in § 26.85(a) or to a require recording other monitors, nor donor during the hydration process to hydration monitor who meets the does it require information when a another collector who meets the requirements in § 26.4(g)(6). If another hydration period is implemented. It is requirements in § 26.85(a) or to a collector or hydration monitor is used, only required to be recorded when a hydration monitor who meets the the collector: direct observed collection takes place. requirements in § 26.31(b)(1)(vi). If 9

Attachment 1 Industry Comments on Part 26, Fitness for Duty Drug Testing Requirements, Proposed Rulemaking Proposed Rule Section Comments Suggested Wording/Revision (i) Shall explain the hydration process another collector or hydration monitor is and acceptable donor behavior to the used, the collector:

hydration monitor; And, recommend to add the following language as § 26.31(b)(1)(vi):

(vi) When a donor is unable to provide an acceptable specimen of 30mL, they are encouraged to follow the hydration process in §26.109(b). During the hydration period, a donor may be under the observation of a hydration monitor as follows:

(A) The donor must be continuously monitored by an individual who does not have a personal relationship with the donor.

(B) Individuals who are assigned to monitor donors during a hydration period shall be provided instructions on the monitoring process and control the donors access to any fluids, and control the hydration process in accordance with 26.109(b);

(C) The hydration monitor shall be responsible for documenting the hydration process in accordance with program procedures.

(ii) Shall record the name of the other Recording the name of the other Recommend to delete (ii) Shall record collector or hydration monitor on the collector or hydration monitor is un- the name of the other collector or Federal CCF and then provide the Federal necessary. The CCF should remain hydration monitor on the Federal CCF CCF to that individual for the duration of with the collector and not the and then provide the Federal CCF to that the hydration process; and hydration monitor. individual for the duration of the 10

Attachment 1 Industry Comments on Part 26, Fitness for Duty Drug Testing Requirements, Proposed Rulemaking Proposed Rule Section Comments Suggested Wording/Revision hydration process; and Subpart ECollecting Specimens for Testing

§ 26.115 Collecting a urine specimen under direct observation.

(e) The collector shall ensure that the Flexibility should be allowed on same Recommend to revise language to read:

observer is the same gender as the gender collections with regards to (e) The collector shall reasonably donor. A person of the opposite gender donors who identify as one gender ensure that the observer is the same may not act as the observer under any however still have the physical gender as the individual donor. The conditions. The observer may be a anatomy of the opposite gender, or observer may be a different person from different person from the collector and those who identify as gender X. In the collector and need not be a qualified need not be a qualified collector. If the these cases, it should be allowable to collector. If the observer is not a observer is not a qualified collector, the have a medical professional of the qualified collector, the collector shall, in collector shall, in the presence of the opposite gender of the donor, such as the presence of the donor, instruct the donor, instruct the observer on the a doctor or nurse complete the direct observer on the collection procedures in collection procedures in paragraph (f) of observation. This would not be paragraph (f) of this section before this section before proceeding with the allowed based on the proposed proceeding with the directly observed directly observed collection. wording. collection.

Subpart HDetermining Fitness-for-Duty Policy Violations and Determining Fitness

§ 26.185 Determining a fitness-for-duty policy violation.

(f) Review of invalid specimens.

(3) If the MRO and the laboratory agree MROs receive the required technical Recommend to delete (f)(3).

that further testing would not be useful instruction for these situations through and there is no legitimate technical or their required AAMRO qualification and 11

Attachment 1 Industry Comments on Part 26, Fitness for Duty Drug Testing Requirements, Proposed Rulemaking Proposed Rule Section Comments Suggested Wording/Revision medical explanation, and the invalid periodic requalification training.

result is based on pH in the range of 9.0 Mandating one course of action, when to 9.5, the MRO shall consider whether the MROs license, training, and there is evidence of elapsed time, qualifications require us to rely upon exposure of the specimen to high their knowledge and skills, is contrary temperature, or both that could account to the MROs role. Unless this is also in for the pH value. If an acceptable other Federal programs, it is explanation exists for the invalid test unnecessary.

result due to pH, based on objective and sufficient information, that elapsed time, high temperature, or both caused the high pH and donor action did not result in the invalid pH result, the MRO shall report a cancelled test result to the licensee or other entity, cancel the test result, and direct the licensee or other entity to collect a second urine specimen from the donor as soon as reasonably practicable. The second specimen collected may not be collected under direct observation.

Subpart GLaboratories Certified by Given the rigorous HHS oversight of Eliminate the need for blind performance the Department of Health and the laboratories, as well as the testing requirements similar to DOTs Human Services business necessity for the laboratories proposed changes in Federal Register

§ 21.168 Blind Performance Testing to maintain a reliable record of Vol. 82, No. 217, November 13, 2017.

accuracy, it is not likely that laboratories would relax their standards simply because the relatively small number of blind specimen tests now required was eliminated.

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Attachment 2 Industry Comments on DG 5040, Urine Specimen Collection and Test Result Review Under 10 CFR PART 26, Fitness for Duty Programs Proposed Language Comments Suggested Wording/Revision C. STAFF REGULATORY GUIDANCE There is no benefit or useful purpose Recommend to revise language to read:

1. Monitoring a donor during the in entering the name of the hydration (7) The area used for hydration should hydration process monitor on the CCF. have a working clock visible to the A. General guidance donor(s) and the collector or hydration (7) Upon transferring responsibility for Synchronizing clocks is difficult to monitor. The collector is ultimately monitoring the donor to the hydration manage and is an un-necessary responsible for monitoring the clock.

monitor, the collector should enter the administrative burden.

name of the hydration monitor on the Federal custody and control form (Federal CCF). The area used for hydration should have a working clock visible to the donor(s) and the collector or hydration monitor. The clock that is used should be synchronized with the clock that the collector uses to document the start of the 3-hour hydration process.

C. STAFF REGULATORY GUIDANCE Throughout the guidance an excessive Recommend to revise language to read:

1. Monitoring a donor during the amount of information is required to (3) If during the hydration process, the hydration process be documented on the CCF. There is collector or hydration monitor observes B. Monitoring the donor during the not adequate room on the CCF to any action or behavior by the donor that hydration process document such information. Most may indicate an attempt to subvert the (3) If during the hydration process, the licensees have internal documentation testing process, a description of the collector or hydration monitor observes processes for documenting this donors conduct should be immediately any action or behavior by the donor that information. documented. If a hydration monitor may indicate an attempt to subvert the observes the donor conduct, the testing process, a description of the hydration monitor shall then inform the donors conduct should be immediately collector of the observation. The documented on the Federal CCF (10 CFR hydration monitor should communicate 26.107(b)). If a hydration monitor this information to the collector while observes the donor conduct, the maintaining continuous monitoring of the 1

Attachment 2 Industry Comments on DG 5040, Urine Specimen Collection and Test Result Review Under 10 CFR PART 26, Fitness for Duty Programs Proposed Language Comments Suggested Wording/Revision hydration monitor shall then inform the donor.

collector of the observation. The hydration monitor should communicate this information to the collector while maintaining continuous monitoring of the donor.

C. STAFF REGULATORY GUIDANCE Clarify that the collector should be Revised language to read: (3) If the

1. Monitoring a donor during the available too. hydration monitor is not qualified as a hydration process collector, the donor shall be transferred D. Providing a specimen during the to an available collector when the donor hydration process is ready to attempt to provide a (3) If the hydration monitor is not specimen.

qualified as a collector, the donor shall be transferred to a collector when the donor is ready to attempt to provide a specimen.

C. STAFF REGULATORY GUIDANCE Proposal of permanently affixed Recommend to revise language to read:

2. Using mirrors during specimen mirrors creates a perception that could Allow for use of mirrors that are not collections under direct observation (10 compromise privacy for non-observed secured to a wall or structure.

CFR 26.115, Collecting a Urine Specimen tests. Use of portable mirrors will under Direct Observation) facilitate temporary collection facilities.

D. All mirrors should be sufficiently affixed or secured to a wall or structure to prevent injury to the occupants in the room, stall, or private area.

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Attachment 2 Industry Comments on DG 5040, Urine Specimen Collection and Test Result Review Under 10 CFR PART 26, Fitness for Duty Programs Proposed Language Comments Suggested Wording/Revision C. STAFF REGULATORY GUIDANCE MROs receive the required technical Recommend to delete section 3.

3. MRO consideration of time and instruction for these situations through temperature for urine specimens with their required AAMRO qualification and invalid test results due to pH in the range periodic requalification training.

of 9.0 to 9.5 (10 CFR 26.185(f)(3)) Mandating one course of action, when the MROs license, training, and qualifications require us to rely upon their knowledge and skills, is contrary to the MROs role. Unless this is also in other Federal programs, it is unnecessary.

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