Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Rules and Regulations 19551 

§ 52.2059 Control strategy: Particular 

matter. 

* * * * * 

(o) EPA approves the maintenance 

plan for the Allentown nonattainment 

area for the 2006 24-hour PM2.5 NAAQS 

submitted by the Commonwealth of 

Pennsylvania on September 5, 2014. 

The maintenance plan includes the 

2017 and 2025 PM2.5 and NOX mobile 

vehicle emissions budgets (MVEBs) for 

Lehigh and Northampton Counties to be 

applied to all future transportation 

conformity determinations and analyses 

for the Allentown nonattainment area 

for the 2006 24-hour PM2.5 NAAQS. 

ALLENTOWN AREA’S MOTOR VEHICLE EMISSION BUDGETS FOR THE 2006 24-HOUR PM2.5 NAAQS IN TONS PER YEAR

Type of control strategy SIP Year PM2.5 NOX Effective date of SIP approval 

Maintenance Plan ........................................... 2017 297 8,081 April 13, 2015. 

2025 234 5,303 April 13, 2015. 

PART 81—DESIGNATION OF AREAS 

FOR AIR QUALITY PLANNING 

PURPOSES 

■ 5. The authority citation for part 81 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

■ 6. Section 81.339 is amended under 

the table entitled ‘‘2006 24-Hour PM2.5

NAAQS’’ by revising the entries for 

‘‘Allentown, PA’’ to read as follows: 

§ 81.339 Pennsylvania 

* * * * * 

PENNSYLVANIA—2006 24-Hour PM2.5

NAAQS 

[Primary and secondary] 

Designated area 

Designation a Classification 

Date 1 Type Date 2 Type 

*******

Allentown, PA: 

Lehigh County ............................. April 13, 2015 ............... Attainment 

Northampton County ................... April 13, 2015 ............... Attainment 

*******

a Includes Indian Country located in each county or area, except as otherwise specified. 

1This date is 30 days after November 13, 2009, unless otherwise noted. 

2This date is July 2, 2014, unless otherwise noted. 

* * * * * 

[FR Doc. 2015–08164 Filed 4–10–15; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF TRANSPORTATION 

Office of the Secretary 

49 CFR Part 40 

[Docket No. OST–2015–0045] 

RIN 2105–AE35 

Use of Electronic Chain of Custody 

and Control Form in DOT-Regulated 

Drug Testing Programs 

AGENCY: Office of the Secretary of 

Transportation (OST), U.S. Department 

of Transportation (DOT). 

ACTION: Final rule. 

SUMMARY: This action amends the U.S. 

Department of Transportation’s (DOT) 

regulations to incorporate changes to the 

Substance Abuse and Mental Health 

Services Administration’s (SAMHSA) 

chain of custody and control form (CCF) 

recently approved by the Office of 

Management and Budget (OMB). 

Specifically, this rulemaking expands 

the DOT’s definition of the CCF to 

include both paper and electronic 

forms. 

DATES: This final rule is effective on 

April 13, 2015. 

FOR FURTHER INFORMATION CONTACT: For 

technical questions about this action, 

contact Mark Snider, Office of Drug and 

Alcohol Policy and Compliance, 1200 

New Jersey Ave. SE., Washington, DC 

20590; telephone: (202) 366–3784; 

email: ODAPCWebMail@dot.gov. 

SUPPLEMENTARY INFORMATION: 

Good Cause for Immediate Adoption 

Section 553(b)(3)(B) of title 5, U.S. 

Code, authorizes agencies to dispense 

with notice and comment procedures 

for rules when the agency for ‘‘good 

cause’’ finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ In this instance, 

the DOT finds that notice and public 

comment to this immediately adopted 

final rule, as well as any delay in the 

effective date of this rule, is 

unnecessary, given that the electronic 

CCF (eCCF) has been approved for use 

by OMB and the DOT is bound by 

statute to follow SAMHSA’s chain of 

custody and control procedures, to 

include use of an OMB-approved CCF. 

I. Authority for This Rulemaking 

This rulemaking is promulgated 

pursuant to the Omnibus Transportation 

Employee Testing Act (OTETA) of 1991 

(Pub. L. 102–143, 105 Stat. 952, (Oct. 28, 

1991)). 

II. Background 

The Federal Workplace Drug Testing 

Program was established by Executive 

Order 12564 on September 15, 1986, 

and further mandated by Congress in 

section 503 of Public Law 100–71 (July 

11, 1987). The Department of Health 

and Human Services (HHS), in 

developing the program, created a 

comprehensive set of standards for the 

Federal workplace drug testing program, 

including chain of custody procedures 

designed to ensure the integrity and 

security of specimens from the time the 

specimen is collected until the time the 

testing results are reported by the 

laboratory. To satisfy the congressional 

mandate, HHS first issued its mandatory 

guidelines on April 11, 1988, and in 

doing so, created the uniform CCF. The 

CCF is the tool by which agencies and 


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19552 Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Rules and Regulations 

participants in the testing process are 

assured that the specimen collected is 

actually that of the tested employee. At 

this time, DOT developed its controlled 

substance program, following in large 

part the mandatory guidelines set forth 

by HHS. 

On October 28, 1991, Congress passed 

OTETA, which codified the DOT’s 

controlled substance testing program for 

its regulated entities and added a 

requirement to develop an alcohol 

testing program. In codifying the DOT 

program, Congress directed the 

Department to continue to ‘‘incorporate 

the [HHS] scientific and technical 

guidelines dated April 11, 1988, and 

any amendments to those guidelines, 

including mandatory guidelines 

establishing . . . strict procedures 

governing the chain of custody of 

specimens collected for controlled 

substances testing.’’ See Pub. L. 102– 

143. As a result of this mandate, the 

DOT has required its regulated entities 

to use the CCF, as developed by HHS 

and approved by OMB. Historically, the 

CCF only has been available for use in 

paper form. On May 28, 2014, OMB 

approved the use of both a paper form 

CCF and an eCCF under the HHS 

Mandatory Guidelines. This final rule is 

necessary to expand the DOT’s 

definition of the CCF to include the 

OMB-approved eCCF. 

As noted above, the CCF is used to 

identify a specimen and to document its 

handling at the collection site. The 

paper CCF is a carbonless form 

consisting of 5 copies as follows: 

Copy 1 Test Facility Copy 

Copy 2 Medical Review Officer Copy 

Copy 3 Collector Copy 

Copy 4 Employer Copy 

Copy 5 Donor Copy 

The eCCF requires the same collection 

of information and distribution of 

information to the relevant parties as the 

paper CCF requires. With the approved 

eCCF, HHS is not requiring collection of 

any new or different information. The 

only change from the paper CCF to the 

eCCF is the mechanism for collecting 

and transmitting the requisite 

information. Before implementing an 

eCCF, HHS-certified laboratories must 

provide a detailed plan and proposed 

standard operating procedures (SOPs) 

for SAMHSA to review and approve 

through SAMHSA’s National Laboratory 

Certification Program (NLCP). The 

review of validation records, specimen 

records, SOPs, staff training records, 

and practices associated with the eCCF 

will be part of the NLCP inspection 

process. Once the eCCF is approved for 

use through the NLCP inspection 

process, it may be used in the DOT drug 

testing program, as well as the Federal 

Workplace Drug Testing Program. For 

more information regarding this 

approval process, please contact the 

Department of Health and Human 

Services, Substance Abuse and Mental 

Health Services Administration, 

Division of Workplace Programs, 

National Laboratory Certification 

Program at (919) 541–7242, or via email 

at nlcp@rti.org. 

It is important to note that electronic 

signatures are not otherwise acceptable 

in Part 40. The use of the eCCF will 

create an exception so that electronic 

signatures will be acceptable on these 

forms only and not throughout the rest 

of Part 40. 

To ensure that the DOT regulations 

conform to SAMHSA’s approved chain 

of custody and control procedures, the 

DOT is issuing this final rule to expand 

the current definition of the CCF in 49 

CFR 40.3 to include all versions of the 

CCF as approved by OMB. We are 

amending § 40.45 to explain that the 5- 

part form can be a paper form or an 

approved electronic form, as long as the 

employer ensures that security and 

confidentiality concerns are addressed. 

The DOT is amending § 40.73 to require 

entities using an eCCF to follow the 

eCCF procedures approved by SAMHSA 

through the NLCP inspection process. 

III. Regulatory Analyses and Notices 

Changes to Federal regulations must 

undergo several analyses. First, 

Executive Orders 12866 and 13563 

direct that each Federal agency shall 

propose or adopt a regulation only upon 

a reasoned determination that the 

benefits of the intended regulation 

justify its costs. Second, the Regulatory 

Flexibility Act of 1980 (Pub. L. 96–354), 

as codified in 5 U.S.C. 601 et seq., 

requires agencies to analyze the 

economic impact of regulatory changes 

on small entities. The Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501 et seq.) requires that DOT consider 

the impact of paperwork and other 

information collection burdens imposed 

on the public and, under the provisions 

of PRA section 3507(d), obtain approval 

from OMB for each collection of 

information it conducts, sponsors, or 

requires through regulations. Finally, 

section (a)(5) of division H of the Fiscal 

Year 2005 Omnibus Appropriations Act, 

Public Law 108–447, 118 Stat. 3268 

(Dec. 8, 2004) and section 208 of the EGovernment Act of 2002, Public Law 

107–347, 116 Stat. 2889 (Dec. 17, 2002) 

requires DOT to conduct a Privacy 

Impact Assessment (PIA) of a regulation 

that will affect the privacy of 

individuals. This portion of the 

preamble summarizes the DOT’s 

analyses of these impacts with respect 

to this final rule. 

Executive Order 12866 and 13563 and 

DOT’s Regulatory Policies and 

Procedures 

This final rule is not a significant 

regulatory action under Executive Order 

12866 and 13563, as well as the 

Department’s Regulatory Policies and 

Procedures. Its provisions make 

conforming amendments to include 

forms that have already been approved 

for use by OMB and that, by statute, the 

DOT is required to use. This rule does 

not propose any major policy changes or 

impose significant new costs or 

burdens. Rather, this rule is expected to 

reduce paperwork burdens for those 

entities that elect to use the new eCCF, 

as noted in SAMHSA’s information 

collection request for the CCF that was 

approved by OMB. For more 

information, you may review 

SAMHSA’s information collection 

request (ICR) 201307–0930–003 and 

supplemental information at 

www.reginfo.gov. 

Regulatory Flexibility Analysis 

The Regulatory Flexibility Act of 1980 

(Public Law 96–354, ‘‘RFA’’), 5 U.S.C. 

601 et seq., establishes ‘‘as a principle 

of regulatory issuance that agencies 

shall endeavor, consistent with the 

objectives of the rule and of applicable 

statutes, to fit regulatory and 

informational requirements to the scale 

of the businesses, organizations, and 

governmental jurisdictions subject to 

regulation. To achieve this principle, 

agencies are required to solicit and 

consider flexible regulatory proposals 

and to explain the rationale for their 

actions to assure that such proposals are 

given serious consideration.’’ The RFA 

covers a wide-range of small entities, 

including small businesses, not-forprofit organizations, and small 

governmental jurisdictions. 

Agencies must perform a review to 

determine whether a rule will have a 

significant economic impact on a 

substantial number of small entities. If 

the agency determines that it will, the 

agency must prepare a regulatory 

flexibility analysis as described in the 

RFA. However, if an agency determines 

that a rule is not expected to have a 

significant economic impact on a 

substantial number of small entities, 

section 605(b) provides that the head of 

the agency may so certify, and a 

regulatory flexibility analysis will not be 

required. The certification must include 

a statement providing the factual basis 

for this determination, and the 

reasoning should be clear. This final 

rule does not require entities to use an 


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Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Rules and Regulations 19553 

eCCF. Rather, it presents another means 

of compliance for all entities, as is 

currently permitted under the HHS 

mandatory guidelines. It does not create 

additional burdens, but may alleviate 

some paperwork burdens if entities opt 

to use the eCCF. Thus, in accordance 

with 5 U.S.C. 605(b), I certify that this 

rule will not have a significant 

economic impact on a substantial 

number of small entities. 

Paperwork Reduction Act 

The PRA requires that the DOT 

consider the impact of paperwork and 

other information collection burdens 

imposed on the public. Because the 

DOT is obligated by statute to use 

whatever procedures and forms that 

SAMHSA adopts with respect to chain 

of custody and control for drug testing 

specimens, SAMHSA has accounted for 

the DOT burden in its recently approved 

information collection request. For more 

information regarding these burdens, 

you may review SAMHSA’s ICR 

201307–0930–003 and supplemental 

information at www.reginfo.gov. 

Privacy Act 

The DOT conducted a PIA of this rule 

as required by section 522(a)(5) of 

division H of the FY 2005 Omnibus 

Appropriations Act, Public Law 108– 

447, 118 Stat. 3268 (Dec. 8, 2004) and 

section 208 of the E-Government Act of 

2002, Public Law 107–347, 116 Stat. 

2889 (Dec. 17, 2002). The assessment 

considers any impacts of the final rule 

on the privacy of information in an 

identifiable form. In addition to the PIA 

issued by HHS in conjunction with its 

ICR for the approved CCF, the DOT 

issued a supplemental PIA, further 

explaining how the eCCF may be used 

by DOT-regulated entities and the 

measures that have been put into place 

to ensure not only the integrity and 

security of the testing process, but the 

privacy of individuals subject to testing. 

Copies of the DOT’s supplemental PIA, 

as well as SAMHSA’s PIA, have been 

placed in the docket for this rulemaking. 

V. How To Obtain Additional 

Information 

A. Rulemaking Documents 

An electronic copy of a rulemaking 

document may be obtained by using the 

Internet—1. Search the Federal 

Document Management System (FDMS) 

Portal (http://www.regulations.gov); or 

2. Access the Government Publishing 

Office’s Web page: www.gpo.gov. 

List of Subjects in 49 CFR Part 40 

Administrative practice and 

procedure, Drug testing, Laboratories, 

Reporting and recordkeeping 

requirements, Safety, Transportation. 

The Amendment 

In consideration of the foregoing, the 

Department of Transportation amends 

part 40 of Title 49, Code of Federal 

Regulations, as follows: 

PART 40—PROCEDURES FOR 

TRANSPORTATION WORKPLACE 

DRUG AND ALCOHOL TESTING 

PROGRAMS 

■ 1. The authority citation for part 40 

continues to read as follows: 

Authority: 49 U.S.C. 101, 102, 301, 322, 

5331, 20140, 31306, and 45101 et seq. 

■ 2. In § 40.3 revise the definition of 

‘‘chain of custody’’ to read as follows: 

§ 40.3 What do the terms of this part 

mean? 

* * * * * 

Chain of custody. The procedure used 

to document the handling of the urine 

specimen from the time the employee 

gives the specimen to the collector until 

the specimen is destroyed. This 

procedure uses the Federal Drug Testing 

Custody and Control Form (CCF) as 

approved by the Office of Management 

and Budget. 

* * * * * 

■ 3. Amend § 40.45 by revising 

paragraph (a) and adding paragraphs 

(c)(5) and (f) to read as follows: 

§ 40.45 What form is used to document a 

DOT urine collection? 

(a) The Federal Drug Testing Custody 

and Control Form (CCF) must be used 

to document every urine collection 

required by the DOT drug testing 

program. You may view this form on the 

Department’s Web site (http://

www.dot.gov/odapc) or the HHS Web 

site (http://

www.workplace.samhsa.gov). 

* * * * * 

(c) * * * 

(5) When using an electronic CCF, 

you must establish adequate 

confidentiality and security measures to 

ensure that confidential employee 

records are not available to 

unauthorized persons. This includes 

protecting the physical security of 

records, access controls, and computer 

security measures to safeguard 

confidential data in electronic form. 

* * * * * 

(f) An employer who uses an 

electronic CCF must ensure that the 

collection site, the primary and split 

laboratories, and MRO have compatible 

systems, and that the employee and any 

other program participants in the testing 

process will receive a legible copy of the 

CCF. 

■ 4. Amend § 40.73 by revising 

paragraph (a) introductory text, 

redesignating paragraph (b) as paragraph 

(c), and adding a new paragraph (b) to 

read as follows: 

§ 40.73 How is the collection process 

completed? 

(a) As the collector, when using the 

paper CCF, you must do the following 

things to complete the collection 

process. You must complete the steps 

called for in paragraphs (a)(1) through 

(7) of this section in the employee’s 

presence. 

* * * * * 

(b) As a collector, when using other 

forms of the CCF as approved by the 

Office of Management and Budget, you 

must follow the procedures approved 

for that form. 

(c) As a collector or collection site, 

you must ensure that each specimen 

you collect is shipped to a laboratory as 

quickly as possible, but in any case, 

within 24 hours or during the next 

business day. 

* * * * * 

Issued under the authority provided in 

Pub. L. 102–143, in Washington, DC, on 

April 6, 2015. 

Anthony R. Foxx, 

Secretary of Transportation. 

[FR Doc. 2015–08256 Filed 4–10–15; 8:45 am] 

BILLING CODE 4910–9X–P 

DEPARTMENT OF TRANSPORTATION 

National Highway Traffic Safety 

Administration 

49 CFR Parts 574 and 579 

[Docket No. NHTSA–2014–0084] 

RIN 2127–AL54 

Tire Identification and Recordkeeping 

AGENCY: National Highway Traffic 

Safety Administration (NHTSA), 

Department of Transportation 

ACTION: Final rule. 

SUMMARY: The tire identification number 

(TIN), which must appear on virtually 

all new and retreaded motor vehicle 

tires sold in the United States, plays an 

important role in identifying which tires 

are subject to recall and remedy 

campaigns for safety defects and 

noncompliances. This final rule makes 

two amendments to the TIN. First, 

because NHTSA has run out of twosymbol codes to identify new tire 

plants, NHTSA is expanding the first 

portion of the TIN, previously known as 


wreier-aviles on DSK5TPTVN1PROD with RULES