Federal Register / Vol. 69, No. 216 / Tuesday, November 9, 2004 / Rules and Regulations 64865

specified by Executive Order 13175 (65 

FR 67249, November 9, 2000). This 

action will not have substantial direct 

effects 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 

specified in Executive Order 13132 (64 

FR 43255, August 10, 1999), because it 

merely authorizes State requirements as 

part of the State RCRA hazardous waste 

program without altering the 

relationship or the distribution of power 

and responsibilities established by 

RCRA. This action also is not subject to 

Executive Order 13045 (62 FR 19885, 

April 23, 1997), because it is not 

economically significant and it does not 

make decisions based on environmental 

health or safety risks. This rule is not 

subject to Executive Order 13211, 

‘‘Actions Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use’’ (66 FR 28355 (May 

22, 2001) ) because it is not a significant 

regulatory action under Executive Order 

12866. 

Under RCRA section 3006(b), EPA 

grants a State’s application for 

authorization as long as the State meets 

the criteria required by RCRA. It would 

thus be inconsistent with applicable law 

for EPA, when it reviews a State 

authorization application, to require the 

use of any particular voluntary 

consensus standard in place of another 

standard that otherwise satisfies the 

requirements of RCRA. Thus, the 

requirements of section 12(d) of the 

National Technology Transfer and 

Advancement Act of 1995 (15 U.S.C. 

272 note) do not apply. As required by 

section 3 of Executive Order 12988 (61 

FR 4729, February 7, 1996), in issuing 

this rule, EPA has taken the necessary 

steps to eliminate drafting errors and 

ambiguity, minimize potential litigation, 

and provide a clear legal standard for 

affected conduct. EPA has complied 

with Executive Order 12630 (53 FR 

8859, March 15, 1988) by examining the 

takings implications of the rule in 

accordance with the ‘‘Attorney 

General’s Supplemental Guidelines for 

the Evaluation of Risk and Avoidance of 

Unanticipated Takings’’ issued under 

the executive order. This rule does not 

impose an information collection 

burden under the provisions of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this document and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication in the Federal Register. A 

major rule cannot take effect until 60 

days after it is published in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). This 

action nevertheless will be effective 

January 10, 2005, because it is an 

immediate final rule.

List of Subjects in 40 CFR Part 271

Environmental protection, 

Administrative practice and procedure, 

Confidential business information, 

Hazardous waste, Hazardous waste 

transportation, Indians—lands, 

Intergovernmental relations, Penalties, 

Reporting and recordkeeping 

requirements.

Authority: This action is issued under the 

authority of sections 2002(a), 3006 and 

7004(b) of the Solid Waste Disposal Act as 

amended 42 U.S.C. 6912(a), 6926, 6974(b).

Dated: October 28, 2004. 

Ira Leighton, 

Acting Regional Administrator, EPA New 

England.

[FR Doc. 04–24920 Filed 11–8–04; 8:45 am] 

BILLING CODE 6560–50–P

DEPARTMENT OF TRANSPORTATION

Office of the Secretary 

49 CFR Part 40

[Docket OST–2003–15245] 

RIN 2105–AD47

Procedures for Transportation 

Workplace Drug and Alcohol Testing 

Programs

AGENCY: Office of the Secretary, DOT.

ACTION: Interim final rule.

SUMMARY: The Department of 

Transportation is amending certain 

provisions of its drug and alcohol 

testing procedures to change 

instructions to laboratories and medical 

review officers with respect to 

adulterated, substituted, and diluted 

specimen results. This change is 

intended to avoid inconsistency with 

new requirements established by the 

U.S. Department of Health and Human 

Services that went into effect on 

November 1, 2004.

DATES: This rule is effective November 

9, 2004. Comments to the interim final 

rule should be submitted by December 

9, 2004. Late-filed comments will be 

considered to the extent practicable.

ADDRESSES: To ensure that you do not 

duplicate your docket submissions, 

please submit them by only one of the 

following means: 

(1) By mail to the Docket Management 

System (SVC–124), U.S. Department of 

Transportation, Room PL–401, 400 

Seventh Street, SW., Washington, DC 

20590–0001; 

(2) By delivery to room PL–401 on the 

Plaza Level of the Nassif Building, 400 

Seventh Street, SW., Washington, DC, 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

The telephone number is (202) 366–

9329; 

(3) By fax to the Docket Management 

Facility at (202) 493–2251; or, 

(4) By electronic means through the 

Web site for the Docket Management 

System at: http://dms.dot.gov. 

The Docket Management Facility 

maintains the public docket for this 

rulemaking. Comments to the docket 

will be available for inspection or 

copying at room PL–401 on the Plaza 

level of the Nassif Building, 400 

Seventh Street, SW., Washington, DC, 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

The public may also review docketed 

comments electronically at: http://

dms.dot.gov. 

Anyone wishing to file a comment 

should refer to the OST docket number 

(OST–2003–15245).

FOR FURTHER INFORMATION CONTACT: Jim 

L. Swart, Deputy Director (S–1), Office 

of Drug and Alcohol Policy and 

Compliance, 400 Seventh Street, SW., 

Washington, DC 20590; telephone 

number (202) 366–3784 (voice), (202) 

366–3897 (fax) , or 

jim.swart@ost.dot.gov (e-mail).

SUPPLEMENTARY INFORMATION: 

Purpose 

Recently, the U.S. Department of 

Health and Human Services (HHS) 

revised their Mandatory Guidelines (69 

FR 19644) with an effective date of 

November 1, 2004. Among the many 

revisions contained in the HHS 

Mandatory Guidelines are the 

requirements that laboratories modify 

substituted specimen and diluted 

specimen testing and reporting criteria. 

HHS revised laboratory requirements for 

adulterated specimen testing. HHS also 

requires each Federal agency to conduct 

specimen validity testing (SVT) to 

determine if urine specimens collected 

under HHS Federal Workplace Drug 

Testing Programs have been adulterated 

or substituted. 

64866 Federal Register / Vol. 69, No. 216 / Tuesday, November 9, 2004 / Rules and Regulations 

While the Department of 

Transportation (DOT) intends to fully 

address all aspects of the HHS changes 

to their Mandatory Guidelines in a 

notice of proposed rulemaking (NPRM) 

to be published in the near future, we 

believe that it is appropriate to make a 

few modifications to part 40 to avoid a 

number of inconsistent requirements 

that the application of both part 40 and 

HHS Mandatory Guidelines may have 

created for laboratories and medical 

review officers (MROs) since November 

1, 2004. Consequently, in this 

document, we are taking the following 

steps:

1. We have removed from part 40 the 

requirement that MROs deal with 

substituted results in a two-tiered 

fashion (i.e., medical review for some 

and recollection under direct 

observation for others). MROs will 

provide medical review and verification 

for all laboratory-reported substituted 

specimen results. This change is 

necessary because, under the HHS 

Mandatory Guidelines, there will be no 

specimens with creatinine levels greater 

than or equal to 2 mg/dL that will be 

considered substituted. 

2. We have also removed all part 40 

references to substituted specimens 

having creatinine levels greater than or 

equal to 2 mg/dL. These simply will no 

longer exist under HHS Mandatory 

Guidelines. 

3. We have made laboratory testing 

criteria for specific gravity and 

creatinine concentration of substituted 

specimens and diluted specimens 

consistent with the HHS Mandatory 

Guidelines. A urine specimen will be 

considered dilute when the creatinine 

concentration is greater than or equal to 

2 mg/dL but less than 20 mg/dL and the 

specific gravity is greater than 1.0010 

but less than 1.0030. Previously, urine 

specimens had been considered dilute 

when the creatinine concentration was 

above 5 mg/dL but less than 20 mg/dL 

and the specific gravity was greater than 

1.001 but less than 1.003. 

4. We have revised § 40.91 to make 

our authorized SVT consistent with the 

HHS Mandatory Guidelines. We have 

adopted HHS instructions that direct 

laboratories to perform validity tests for 

oxidizing adulterants and additional 

validity tests when certain conditions 

(e.g., abnormal physical characteristics) 

are observed. 

5. We have made laboratory results 

reporting requirements parallel to those 

in the HHS Mandatory Guidelines (with 

the exception of negative-dilute 

specimen results, explained in the 

section below). 

Background 

The DOT issued an interim final rule 

(IFR) on May 28, 2003 (68 FR 31624) in 

order to respond to scientific and 

medical information suggesting that we 

modify testing criteria for some 

specimens that were considered to be 

substituted and ultimately were treated 

as refusals to test. That 2003 IFR did not 

change the substitution criteria 

established by the HHS that we had 

used for our substitution criteria. 

However, the 2003 IFR required 

laboratories to report the numerical 

values of substituted specimens to 

MROs. 

MROs were subsequently directed by 

the 2003 IFR to treat a substituted result 

as negative-dilute if the creatinine 

concentration was greater than or equal 

to 2 mg/dL. But, unlike part 40 

procedures with other negative-dilute 

specimen results, MROs were instructed 

to direct employers to have the 

employee return to the collection site 

for a directly observed collection with 

no prior notice given to the employee. 

The result of the observed collection 

would be the result of record for the 

entire testing event. The HHS 

Mandatory Guidelines’ approach to 

substituted test results allows DOT to 

simplify our guidance to MROs on how 

to deal with them. 

The 2003 IFR solicited comments, and 

we received them from a dozen 

commenters. We will address these 

comments in the preamble to the 

forthcoming NPRM. In addition, some 

comments to the 2003 IFR mirrored 

comments that HHS received to the 

portion of the Mandatory Guidelines for 

which they requested comments. We 

will also take the HHS docket comments 

and their response to them into 

consideration in our upcoming NPRM. 

While we have changed a number of 

items in part 40 to bring consistency 

between part 40 and the HHS 

Mandatory Guidelines (see previous 

section) regarding SVT, there are several 

important items on which the DOT and 

HHS rules will differ. 

1. The DOT will maintain its current 

position that SVT is authorized but not 

required. In our 2000 regulation (65 FR 

79462), we made SVT mandatory but 

retracted the requirement in technical 

amendments published in 2001 (66 FR 

41944). We will not make SVT 

mandatory as a feature of this IFR, but 

may propose, in a forthcoming NPRM 

that we are considering, that such 

testing be made mandatory. Therefore, 

§ 40.89 remains unchanged by this IFR. 

However, laboratories conducting SVT 

of DOT specimens must do so in 

accordance with the testing 

requirements established in the HHS 

Mandatory Guidelines. 

In proposing mandatory SVT in the 

NPRM, we would consider HHS’ entire 

Mandatory Guidelines and any 

subsequent HHS handbook materials. 

We would also update our cost figures 

for SVT (that were originally calculated 

four years ago) in the context of such a 

proposal. Ultimately, this should enable 

DOT-regulated employers not currently 

conducting SVT the time needed to 

arrange with their laboratories and 

Consortia/Third Party Administrators to 

do so. 

2. In this IFR, we will require MROs 

to treat laboratory reported negativedilute results with creatinine levels 

greater than or equal to 2 mg/dL but 

equal to or less than 5 mg/dL as 

negative-dilutes that require immediate 

recollections under direct observation. 

Therefore, MRO procedures at § 40.155 

reflect this requirement and employers 

will continue to follow their obligations 

for negative-dilute results at § 40.197(b) 

and (c).

3. To assist MROs with their negativedilute results responsibilities, we will 

require laboratories to provide 

creatinine and specific gravity 

numerical values for all specimens they 

report to the MRO as being negativedilute. 

Regulatory Analyses and Notices 

The statutory authority for this rule 

derives from the Omnibus 

Transportation Employee Testing Act of 

1991 (49 U.S.C. 102, 301, 322, 5331, 

20140, 31306, and 54101 et seq.) and the 

Department of Transportation Act (49 

U.S.C. 322). 

This rule is not significant for 

purposes of Executive Order 12866 or 

the DOT’s regulatory policies and 

procedures. It represents minor 

modifications to our procedures which 

are intended to further align our 

laboratory and MRO procedures with 

those requirements that are being 

directed by HHS. Their economic effects 

will be negligible. Consequently, the 

Department certifies, under the 

Regulatory Flexibility Act, this rule will 

not have a significant economic impact 

on a substantial number of small 

entities. 

Under the criteria of section 553 of 

the Administrative Procedure Act 

(APA), an agency may, for good cause, 

determine that prior notice and public 

comment are impractical, unnecessary, 

or contrary to the public interest. The 

Department believes good cause exists 

for this interim change to be made 

without prior notice and public 

comment. It is imperative that some 

significant laboratory and MRO 

Federal Register / Vol. 69, No. 216 / Tuesday, November 9, 2004 / Rules and Regulations 64867

requirements of the Department’s 

regulation and that of HHS be 

harmonized.

List of Subjects in 49 CFR Part 40

Administrative practice and 

procedures, Alcohol abuse, Alcohol 

testing, Drug abuse, Drug testing, 

Laboratories, Reporting and 

recordkeeping requirements, Safety, 

Transportation.

Issued this 4th Day of November, 2004, at 

Washington DC. 

Norman Y. Mineta, 

Secretary of Transportation.

■ For reasons discussed in the preamble, 

the Department of Transportation 

amends part 40 of Title 49 Code of 

Federal Regulations, subtitle A, as 

follows:

PART 40—PROCEDURES FOR 

TRANSPORTATION WORKPLACE 

DRUG AND ALCOHOL TESTING 

PROGRAMS

■ 1. The authority citation for 49 CFR 

Part 40 is revised to read as follows:

Authority: 49 U.S.C. 102, 301, 322, 5331, 

20140, 31306, and 54101 et seq.; 49 U.S.C. 

322.

■ 2. Section 40.67 is amended by 

revising paragraph (a)(3) to read as 

follows:

§ 40.67 When and how is a directly 

observed collection conducted? 

(a) * * *

(3) The laboratory reported to the 

MRO that the specimen was negativedilute with a creatinine concentration 

greater than or equal to 2 mg/dL but less 

than or equal to 5 mg/dL, and the MRO 

reported the specimen to you as 

negative-dilute and that a second 

collection must take place under direct 

observation (see § 40.197(b)(1)).

* * * * *

■ 3. Section 40.91 is amended by 

revising paragraphs (a), (b), (c), (d), and 

(e) and by removing paragraph (f) as 

follows:

§ 40.91 What validity tests must 

laboratories conduct on primary 

specimens?

* * * * *

(a) You must determine the creatinine 

concentration on each primary 

specimen. You must also determine its 

specific gravity if you find the 

creatinine concentration to be less than 

20 mg/dL. 

(b) You must determine the pH of 

each primary specimen. 

(c) You must perform one or more 

validity tests for oxidizing adulterants 

on each primary specimen. 

(d) You must perform additional 

validity tests on the primary specimen 

when the following conditions are 

observed: 

(1) Abnormal physical characteristics; 

(2) Reactions or responses 

characteristic of an adulterant obtained 

during initial or confirmatory drug tests 

(e.g., non-recovery of internal standards, 

unusual response); or 

(3) Possible unidentified interfering 

substance or adulterant.

(e) If you determine that the specimen 

is invalid and HHS guidelines direct 

you to contact the MRO, you must 

contact the MRO and together decide if 

testing the primary specimen by another 

HHS certified laboratory would be 

useful in being able to report a positive 

or adulterated test result.

■ 4. Section 40.93 is revised to read as 

follows:

§ 40.93 What criteria do laboratories use to 

establish that a specimen is dilute or 

substituted? 

(a) As a laboratory, you must consider 

the primary specimen to be dilute when: 

(1) The creatinine concentration is 

greater than or equal to 2 mg/dL but less 

than 20 mg/dL, and 

(2) The specific gravity is greater than 

1.0010 but less than 1.0030 on a single 

aliquot. 

(b) As a laboratory, you must consider 

the primary specimen to be substituted 

when the creatinine concentration is 

less than 2 mg/dL and the specific 

gravity is less than or equal to 1.0010 or 

greater than or equal to 1.0200 on both 

the initial and confirmatory creatinine 

tests and on both the initial and 

confirmatory specific gravity tests on 

two separate aliquots.

■ 5. Section 40.97 is amended by 

revising (a)(2), (6) and (7) and (e)(1) and 

(2), and adding paragraph (e)(3), to read 

as follows:

§ 40.97 What do laboratories report and 

how do they report it? 

(a) * * *

(2) Negative-dilute, with numerical 

values for creatinine and specific 

gravity;

* * * * *

(6) Adulterated, with numerical 

values (when applicable), with 

remark(s); 

(7) Substituted, with numerical values 

for creatinine and specific gravity; or

* * * * *

(e)(1) You must provide quantitative 

values for confirmed positive drug test 

results to the MRO when the MRO 

requests you to do so in writing. The 

MRO’s request may be either a general 

request covering all such results you 

send to the MRO or a specific case-bycase request. 

(2) You must provide the numerical 

values that support the adulterated 

(when applicable) or substituted result, 

without a request from the MRO. 

(3) You must also provide to the MRO 

numerical values for creatinine and 

specific gravity for the negative-dilute 

test result, without a request from the 

MRO.

* * * * *

§ 40.131 [Amended]

■ 6. Section 40.131(a) is amended by 

removing, after the word ‘‘substituted’’

and before the comma, the words ‘‘with 

creatinine concentration of less than 2 

mg/dL’’.

■ 7. Section 40.145 is amended by 

revising paragraphs (a) and (e)(2) to read 

as follows:

§ 40.145 On what basis does the MRO 

verify test results involving adulteration or 

substitution? 

(a) As an MRO, when you receive a 

laboratory report that a specimen is 

adulterated or substituted, you must 

treat that report in the same way you 

treat the laboratory’s report of a 

confirmed positive for a drug or drug 

metabolite.

* * * * *

(e) * * *

(2) To meet this burden in the case of 

a substituted specimen, the employee 

must demonstrate that he or she did 

produce or could have produced urine 

through physiological means, meeting 

the creatinine concentration criterion of 

less than 2 mg/dL and the specific 

gravity criteria of less than or equal to 

1.0010 or greater than or equal to 1.0200 

(see § 40.93(b)).

* * * * *

■ 8. Section 40.155 is amended by 

revising paragraphs (a) and (c) to read as 

follows:

§ 40.155 What does the MRO do when a 

negative or positive test result is also 

dilute? 

(a) When the laboratory reports that a 

specimen is dilute, you must, as the 

MRO, report to the DER that the 

specimen, in addition to being negative 

or positive, is dilute.

* * * * *

(c) When you report a dilute specimen 

to the DER, you must explain to the DER 

the employer’s obligations and choices 

under § 40.197, to include the 

requirement for an immediate 

recollection under direct observation if 

the creatinine concentration of a 

negative-dilute specimen was greater 

than or equal to 2mg/dL but less than 

or equal to 5mg/dL.

64868 Federal Register / Vol. 69, No. 216 / Tuesday, November 9, 2004 / Rules and Regulations 

§ 40.197 [Amended]

■ 9. Section 40.197 (b)(1) is amended by 

replacing the words ‘‘(see 

§ 40.145(a)(1))’’ with the words ‘‘(see 

§ 40.155(c))’’.

[FR Doc. 04–25025 Filed 11–8–04; 8:45 am] 

BILLING CODE 4910–62–P