New Entrant Safety Audit: Drug and Alcohol File Checklist
Short answer: a new carrier automatically fails the safety audit if it breaks any one of five drug and alcohol rules listed in 49 CFR 385.321, even once. Beyond those five, the auditor looks at the records Part 382 tells you to keep, and FMCSA can ask to see them at your principal place of business within two business days (382.401(d)). Print this page and tick off each item before the audit.
Updated October 15, 2026 · Checked against the federal regulations
Check these first: the five automatic failures
Section 385.321 lists 16 violations that fail a new entrant safety audit on their own. Five are drug and alcohol rules, and for each one a "single occurrence" is enough. The other eleven cover CDLs, disqualified or medically unqualified drivers, insurance, hours of service and vehicle repairs.
- ☐ A drug and alcohol testing program was in place on the day you began operating commercial motor vehicles (382.115(a)).
- ☐ A random testing program is in place (382.305). If you are your only driver, you are in a random pool of two or more covered employees (382.103(b)), for example a C/TPA's larger pool (382.305(j)(2)).
- ☐ No driver who refused a required test has driven or done other safety-sensitive work since (382.211).
- ☐ No driver known to have tested positive for drugs has driven since (382.215).
- ☐ No driver known to have an alcohol concentration of 0.04 or higher has driven (382.201).
Policy and training
- ☐ Your written policy (educational materials) covering every topic in 382.601(b), including what gets reported to the Clearinghouse.
- ☐ Each driver's signed statement that they received the policy (382.601(d)).
- ☐ Proof every supervisor of drivers had at least 60 minutes of training on alcohol misuse and 60 minutes on controlled substances use (382.603). No refresher is required.
- ☐ Names and positions of the people who run your program and their roles, such as your designated employer representative (382.401(c)(6)(ii)).
Each driver's test file
- ☐ A verified negative pre-employment drug test result from the MRO or C/TPA, received before the driver first did safety-sensitive work (382.301(a)). If you used the recent-testing exception instead, the program information 382.301(c) says to get and keep.
- ☐ Your copy of each drug test custody and control form and each alcohol test form (382.401(c)(2)).
- ☐ Documents the MRO sent you, and any documents about a refusal or a driver disputing a result.
- ☐ Records of checking each new driver's drug and alcohol history with prior employers (382.401(c)(2)(vi)).
- ☐ Any substance abuse professional (SAP) evaluations and records of the driver following the SAP's recommendations (382.401(c)(4)).
Random testing records
- ☐ Documents showing how drivers were selected (382.401(c)(1)(ii)). Selection must use a scientifically valid method, with every driver having an equal chance each time (382.305(i)).
- ☐ Proof you tested at or above the minimum rates: 50 percent of average driver positions for drugs and 10 percent for alcohol (382.305(b)).
- ☐ Dates showing tests were unannounced and spread reasonably through the year (382.305(k)).
- ☐ If a C/TPA runs your pool, its reports. You still must make sure it tests at the right rate and that only covered drivers are in the pool (382.305(j)(2)).
Clearinghouse records
- ☐ A full pre-employment Clearinghouse query for each driver, with the driver's consent, before they drove for you (382.701(a)).
- ☐ A query for every driver at least once a year (382.701(b)).
- ☐ A record of each query and its results, kept 3 years. A valid Clearinghouse registration meets this requirement (382.701(e)).
Post-accident and reasonable suspicion
- ☐ Documents on each decision to test, or not test, after an accident (382.401(c)(1)(vi)).
- ☐ If a post-accident alcohol test wasn't done within 2 hours, a written reason; if not done within 8 hours, a record of why attempts stopped. The same for a drug test not done within 32 hours (382.303(d)).
- ☐ For each reasonable suspicion test, the supervisor's signed written record of what they observed, made within 24 hours or before the results were released, whichever came first (382.307(f)).
- ☐ Agreements with your collection sites, laboratory, MRO, consortium or third-party administrator (382.401(c)(6)(i)).
- ☐ A copy of any annual MIS summary FMCSA asked you for (382.403).
How long to keep each record
Records go in a secure place with controlled access (382.401(a)). Minimum periods under 382.401(b):
- 5 years: alcohol results of 0.02 or higher, verified positive drug results, refusals, SAP evaluations and referrals, program administration records, and annual MIS summaries.
- 2 years: collection process records.
- 1 year: negative and canceled drug results and alcohol results under 0.02.
- Training records: while the person does the job, plus 2 years after.
- Clearinghouse queries: 3 years (382.701(e)).
How Pact handles it
Pact runs your random pool and Clearinghouse queries, schedules tests, and keeps the testing records from them in one place, so you can send them when FMCSA asks. Pact is a private company, not affiliated with FMCSA. The regulations and your auditor are the final word, and this checklist doesn't cover the audit's other parts, such as driver qualification files, hours of service and maintenance.
Common questions
What drug and alcohol violations automatically fail a new entrant safety audit?
Five, each on a single occurrence: no testing program (382.115), no random program (382.305), using a driver who refused a test (382.211), using a driver known to have tested positive for drugs (382.215), and using a driver known to have an alcohol concentration of 0.04 or higher (382.201).
How fast do I have to produce my drug and alcohol records?
Within two business days after an FMCSA request, at your principal place of business (382.401(d)).
I am an owner-operator with no other drivers. Do I still need a random program?
Yes. An employer whose only driver is themself must be in a random pool of two or more covered employees (382.103(b)). A C/TPA's larger pool meets this (382.305(j)(2)).
Do supervisors need refresher training?
No. Section 382.603 requires 60 minutes on alcohol and 60 minutes on drugs once, and says recurrent training is not required. Keep the training record while they supervise and for 2 years after.
Sources
- 49 CFR 385.321: Safety audit failure (automatic failures table)
- 49 CFR 382.401: Retention of records
- 49 CFR 382.115: Starting date for testing programs
- 49 CFR 382.103: Applicability
- 49 CFR 382.211: Refusal to submit to a required test
- 49 CFR 382.301: Pre-employment testing
- 49 CFR 382.303: Post-accident testing
- 49 CFR 382.305: Random testing
- 49 CFR 382.307: Reasonable suspicion testing
- 49 CFR 382.403: Management information system reports
- 49 CFR 382.601: Employer policy
- 49 CFR 382.603: Training for supervisors
- 49 CFR 382.701: Drug and Alcohol Clearinghouse