60318 Federal Register / Vol. 77, No. 192 / Wednesday, October 3, 2012 / Rules and Regulations 

DEPARTMENT OF TRANSPORTATION 

Office of the Secretary 

49 CFR Part 40 

[Docket DOT–OST–2010–0026] 

RIN 2105–AE14 

Procedures for Transportation 

Workplace Drug and Alcohol Testing 

Programs: 6-acetylmorphine (6-AM) 

Testing 

AGENCY: Office of the Secretary, U.S. 

Department of Transportation (DOT). 

ACTION: Final rule. 

SUMMARY: This rule adopts as final, 

without change, a May 4, 2012, interim 

final rule (IFR) which no longer requires 

laboratories and Medical Review 

Officers (MRO) to consult with one 

another regarding the testing for the 

presence of morphine when the 

laboratory confirms the presence of 6- 

acetylmorphine (6-AM). Also, 

laboratories and MROs will no longer 

need to report 6-AM results to the Office 

of Drug and Alcohol Policy and 

Compliance (ODAPC). This rule also 

responds to comments on the IFR. 

DATES: The rule is effective October 3, 

2012. 

FOR FURTHER INFORMATION CONTACT: 

Bohdan Baczara, U.S. Department of 

Transportation, Office of Drug and 

Alcohol Policy and Compliance, 1200 

New Jersey Avenue SE., Washington, 

DC 20590; 202–366–3784 (voice), 202– 

366–3897 (fax), or 

bohdan.baczara@dot.gov (email). 

SUPPLEMENTARY INFORMATION: 

Background and Purpose 

On August 16, 2010, [75 FR 49850] 

the Department published its final rule 

to harmonize with many aspects of the 

revised Department of Health and 

Human Services (HHS) Mandatory 

Guidelines [73 FR 71858]. One item 

with which the DOT harmonized was 

the laboratory testing for 6- 

acetylmorphine (6-AM) without a 

morphine marker. 6-AM is a unique 

metabolite produced when a person 

uses the illicit drug heroin. Prior to the 

October 1, 2010, rulemaking, both the 

HHS and Department of Transportation 

(DOT) regulations required the 

laboratory to first test for morphine, and 

if it detected morphine at the HHS/DOT 

cutoff of 2000ng/mL, the lab would then 

test for 6-AM. 

For the reasons discussed in the DOT 

final rule [75 FR 49850], we decided 

that, until more experience was gained 

with the new testing procedures for 6- 

AM, we would place additional 

requirements on laboratories and MROs. 

Specifically, when there was a 6-AM 

positive result and morphine was not 

detected by a laboratory at the 2000ng/ 

mL cutoff, we added a requirement for 

the laboratory and MRO to determine 

whether morphine was detected at the 

laboratory’s level of detection (LOD). If 

morphine was not detected at the 

laboratory’s LOD, the laboratory and 

MRO were to report that result to DOT’s 

Office of Drug and Alcohol Policy and 

Compliance (ODAPC). After consulting 

with ODAPC, the MRO would make a 

verified result determination, keeping in 

mind that there is no legitimate 

explanation for 6-AM in the employee’s 

specimen [see § 40.151(g)]. The 

Department would track these results 

and discuss them with HHS. 

On May 4, 2012, the Department 

issued an IFR [77 FR 26471] and 

effective July 3, 2012, related to 6-AM 

testing. For reasons stated in that IFR, 

we removed the requirement for 

laboratories and MROs to consult with 

one another regarding the testing for the 

presence of 6-AM. The IFR also 

streamlined the laboratory analysis and 

MRO reporting of 6-AM results by not 

having either the laboratory or MRO 

report the 6-AM information to ODAPC. 

The IFR also sought comments to the 

IFR which were to be submitted by June 

4, 2012. There were two such 

comments. 

Discussion of Comments to the Docket 

There were two comments to the 

docket representing three organizations. 

One comment was submitted by a large 

organization which represents 

physicians who are MROs. The other 

comment was submitted by a large 

medical review officer service and 

consortium which provide drug and 

alcohol testing services primarily to the 

pipeline industry. 

Each of the commentors fully 

supported the Department’s position on 

amending the requirements for testing 

and reporting 6-AM test results. Their 

support of the IFR further reinforces that 

there are no legitimate medical 

explanations for the confirmation of 6- 

AM on a DOT drug test and that the 

MRO must make positive results 

determinations in these cases. 

One commenter asked whether we 

had noted a spike followed by a decline 

in the 6-AM results during the first year 

of testing, as they did. They wondered 

whether our commissioned study was 

designed to shed light on their 

observation. 

We would note that over time, the 

Department has indeed seen an increase 

of laboratory-reported 6-AM test results. 

However, we found that the largest 

semi-annual period rise of 6-AM results, 

by number and percentage increase, 

came even before the October 2010 

effective date of the new rules. This 

larger rise was noted when we 

compared the July–December 2009 

period with the January–June 2010 

period. Also, it is important to note that 

the number of total drug tests reported 

by laboratories has risen during each 6- 

month period, starting with the July– 

December 2009 period, and the number 

of 6-AM positive results has steadily 

risen each period since July–December 

2008. 

The following table displays the 

laboratory data for 6-AM before, during 

transition, and after full implementation 

of the new testing protocols: 

Semi-Annual period 2008 

July–Dec 

2009 

Jan–June 

2009 

July–Dec 

2010 

Jan–June 

2010 *

July–Dec 

2011 

Jan–June 

2011 

July–Dec 

Total Laboratory Test Results.2.85 million ... 2.59 million ... 2.57 million ... 2.69 million ... 2.77 million ... 2.82 million ... 2.87 million 

6-AM Laboratory Positives .. 121 ............... 158 ............... 173 ............... 281 ............... 298 ............... 371 ............... 429 

*The new requirement for 6-AM testing was in effect for the last 3 months of the period. 


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Federal Register / Vol. 77, No. 192 / Wednesday, October 3, 2012 / Rules and Regulations 60319 

Our commissioned study was not 

designed to evaluate the pattern of 6- 

AM test results over time. Its scope was 

‘‘* * * to verify the atypical results 

obtained by the laboratories, to 

determine if other drug or metabolites 

present in the specimens could explain 

the absence of morphine, and to 

determine if something other than 

heroin use could explain the presence of 

6-AM.’’ [77 FR 26472] The study’s 

findings were presented and discussed 

in the IFR. [77 FR 26472] We would 

note that the rise in 6-AM positives was 

predicted, and a rise seems to have 

become the trend over time. 

For the reasons discussed above and 

outlined in the IFR, we are adopting the 

rule text in the IFR as final. 

Regulatory Analyses and Notices 

Authority 

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). 

Executive Order 12866 and Regulatory 

Flexibility Act 

This Final Rule is not significant for 

purposes of Executive Order 12866 or 

the DOT’s regulatory policies and 

procedures. It finalizes modifications, 

already in effect, to our procedures that 

do not increase costs on regulated 

parties. The rule will impose no new 

burdens on any parties, and will 

actually decrease the burden upon the 

laboratories and the MROs. I hereby 

certify, under the Regulatory Flexibility 

Act, that this rule does not have a 

significant economic impact on a 

substantial number of small entities. 

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. 

Accordingly, the Interim Final Rule 

amending 49 CFR Part 40 which was 

published at 77 FR 26471 on May 4, 

2012 is adopted as a final rule without 

change. 

Issued on September 20th, 2012, at 

Washington DC 

Ray LaHood, 

Secretary of Transportation. 

[FR Doc. 2012–24337 Filed 10–2–12; 8:45 am] 

BILLING CODE 4910–9X–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 229 

RIN 0648–XC099 

Harbor Porpoise Take Reduction Plan; 

Coastal Gulf of Maine Closure Area 

Established With a Temporary Shift of 

Its Effective Date 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Establishment of the Coastal 

Gulf of Maine Closure Area; temporary 

shift of its effective date. 

SUMMARY: Through this notice, NOAA’s 

National Marine Fisheries Service 

(NMFS) announces the establishment of 

the Coastal Gulf of Maine Closure Area 

under the Harbor Porpoise Take 

Reduction Plan (Plan), and temporarily 

shifts the effective date of year 1 of its 

implementation from October 1, 2012, 

to February 1, 2013. Recent information 

suggests that harbor porpoise bycatch is 

higher in February and March than in 

October and November since the 

implementation of sectors in May 2010, 

warranting a temporary shift of the 

closure in year 1 to a time period that 

would provide greater conservation 

benefit to harbor porpoises and allow 

time for more complete consideration of 

updated information on harbor porpoise 

bycatch, harbor porpoise abundance, 

and fishing effort by the Harbor 

Porpoise Take Reduction Team (Team). 

As such, this area will be closed to 

gillnet fishing in February and March of 

2013 rather than October and November 

of 2012. 

DATES: Year 1 effective February 1, 

2013; Year 2 and beyond effective 

October 1, 2013. 

FOR FURTHER INFORMATION CONTACT: Kate 

Swails, NMFS, Northeast Region, 978– 

282–8481, kate.swails@noaa.gov; or 

Kristy Long, NMFS, Office of Protected 

Resources, 301–427–8402, 

kristy.long@noaa.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

The Harbor Porpoise Take Reduction 

Plan (Plan) was implemented in late 

1998 pursuant to section 118(f) of the 

Marine Mammal Protection Act 

(MMPA) to reduce the level of serious 

injury and mortality of the Gulf of 

Maine/Bay of Fundy (GOM/BOF) stock 

of harbor porpoises (63 FR 66464, 

December 2, 1998). NMFS amended the 

Plan in 2010 (75 FR 7383, February 19, 

2010) to address increased mortalities of 

harbor porpoises in New England and 

Mid-Atlantic commercial gillnet 

fisheries due to non-compliance with 

the Plan requirements and observed 

interactions occurring outside of 

existing management areas. 

The 2010 amendments, based largely 

on consensus recommendations from 

the Team, included the expansion of 

seasonal and temporal requirements 

within the Plan’s management areas, the 

incorporation of additional management 

areas, and the creation of three closure 

areas off the coast of New England that 

would prohibit the use of gillnet gear if 

certain levels of harbor porpoise bycatch 

are exceeded (consequence closure area 

strategy). 

For New England, the 2010 

amendments to the Plan implemented a 

‘‘consequence’’ closure strategy, which 

would close specific areas to gillnet gear 

during certain times of the year if 

observed average bycatch rates exceed 

specified target bycatch rates over the 

course of two consecutive management 

seasons. If observed bycatch rates 

exceeded the target rates, the following 

three areas would become closed: the 

Coastal Gulf of Maine, Eastern Cape 

Cod, and Cape Cod South Expansion 

Consequence Closure Areas. This 

measure was intended to provide an 

incentive for the gillnet industry to 

comply with pinger requirements in 

areas with historically high harbor 

porpoise bycatch levels resulting from 

relatively low levels of compliance. The 

consequence closures, if implemented, 

would further reduce harbor porpoise 

mortalities due to the times and areas 

chosen for their implementation. 

The Coastal Gulf of Maine 

Consequence Closure would be 

triggered if the observed average bycatch 

rates of harbor porpoises in the MidCoast, Stellwagen Bank, and 

Massachusetts Bay Management Areas 

(combined) exceed the target bycatch 

rate of 0.031 harbor porpoise takes/ 

metric tons of fish landed (takes/mtons) 

(1 harbor porpoise taken per 71,117 

pounds of fish landed) after two 

consecutive management seasons. If 

triggered, the use of gillnet gear would 

be prohibited during the months of 

October and November, which 

historically have been the months with 

the highest amount of observed harbor 

porpoise bycatch. When this area is not 

closed, the seasonal requirements of the 

three overlapping management areas, 

including the March gillnet closure in 

the Massachusetts Bay Management 

Area, would remain in effect. 

The Cape Cod South Expansion and 

Eastern Cape Cod Consequence Closures 


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