Federal Register / Vol. 77, No. 87 / Friday, May 4, 2012 / Rules and Regulations 26471 

of FFDCA section 408(n)(4). As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule 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 of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: April 25, 2012. 

Daniel J. Rosenblatt, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.609 is amended by 

revising the following entries in the 

table in paragraph (a)(1) to read as 

follows: 

§ 180.609 Fluoxastrobin; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

* * * * * 

Peanut ............................... 0.02 

* * * * * 

Peanut, refined oil ............. 0.06 

* * * * * 

* * * * * 

[FR Doc. 2012–10704 Filed 5–3–12; 8:45 am] 

BILLING CODE 6560–50–P 

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, DOT. 

ACTION: Interim final rule. 

SUMMARY: The Department is amending 

certain provisions of its drug testing 

procedures for 6-acetylmorphine (6– 

AM), a unique metabolite of heroin. 

Laboratories and Medical Review 

Officers (MROs) will no longer be 

required to consult with one another 

regarding the testing for the presence of 

morphine when the laboratory confirms 

the presence of 6–AM. This rule is 

intended to streamline the laboratory 

process for analyzing and reporting 6– 

AM positive results and will facilitate 

MRO verification of 6–AM positive 

results. 

DATES: The rule is effective July 3, 2012. 

Comments to this interim final rule 

should be submitted by June 4, 2012. 

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: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov and follow 

the online instructions for submitting 

comments. 

• Mail: Docket Management Facility, 

U.S. Department of Transportation, 1200 

New Jersey Ave. SE., West Building 

Ground Floor Room W12–140, 

Washington, DC 20590–0001; 

• Hand Delivery: West Building 

Ground Floor, Room W12–140, 1200 

New Jersey Ave. SE., between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. The telephone 

number is 202–366–9329; 

Instructions: You must include the 

agency name and docket number DOTOST–2010–0026 or the Regulatory 

Identification Number (2105–AE14) for 

the rulemaking at the beginning of your 

comments. All comments received will 

be posted without change to http:// 

www.regulations.gov, including any 

personal information provided. 

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 

For its drug testing regulation, the 

Department of Transportation (DOT) is 

required by the Omnibus Transportation 

Employee Testing Act of 1991 (Omnibus 

Act) to incorporate the laboratory testing 

protocols and standards established by 

the U.S. Department of Health and 

Human Services (HHS). The Omnibus 

Act requires that we utilize HHScertified laboratories and that we follow 

the HHS Mandatory Guidelines for 

identifying the specific drugs for which 

we test and the scientific methodologies 

the laboratories must use for testing. 

Because of these requirements and to 

create consistency with certain aspects 

of the new HHS Mandatory Guidelines 

effective October 1, 2010 [73 FR 71858], 

the DOT published its final rule on 

August 16, 2010 [75 FR 49850], also 

effective October 1, 2010, to harmonize 

with many aspects of the revised 

Mandatory Guidelines. 

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 HHS 

and 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. 


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26472 Federal Register / Vol. 77, No. 87 / Friday, May 4, 2012 / Rules and Regulations 

1Anomalous Results of Morphine and 6- 

Acetylmorphine in Urine Specimens, Abstract at 

the 2011 Joint Meeting of Society of Forensic 

Toxicologists (SOFT) & The International 

Association of Forensic Toxicologists (TIAFT), San 

Francisco, CA, September 25–30, 2011. 

2 Ibid. 

In our final rule, we discussed the 

concern some commentors had about 

whether morphine needed to be present 

with a confirmed positive 6–AM result. 

We discussed the data and studies 

submitted to the docket addressing the 

question of whether there was research 

or studies showing that morphine must 

also be present and at what 

quantitations. As stated at 75 FR 49856, 

based on the comments to the docket 

and multiple scientific publications, the 

facts were: 

• 6–AM confirmed positive tests do 

not need a morphine marker; 

• Data showed that when one looks 

for morphine as a marker, it most 

always exists above the morphine 

confirmation cutoffs or above Limit of 

Detection (LOD); and 

• If the morphine marker does not 

exist on a 6–AM positive result, there is 

ample scientific reason to strongly 

suggest recent heroin use. 

We decided that, until more 

experience was gained with the new 

testing procedures for 6–AM, we would 

place additional requirements on the 

laboratories and the MROs. Specifically, 

when morphine was not detected at the 

HHS/DOT cutoff of 2000ng/mL, we 

added a requirement for the laboratory 

and MRO to determine whether 

morphine was detected at the 

laboratory’s 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)]. 

Policy Discussion 

From the October 1, 2010 effective 

date of the final rule through September 

30, 2011, ODAPC has received, on 

average, 14 results per month from the 

laboratories and MROs that a specimen 

was positive for 6–AM with no 

morphine at the laboratory’s LOD. 

During this period, we learned that the 

laboratory LODs ranged from 100ng/mL 

to 600ng/mL, and were set in 

accordance with National Laboratory 

Certification Program guidance to them. 

As part of our monitoring process and 

with the varying LODs in mind, DOT 

worked with HHS to have their 

contractor, RTI International (RTI), 

conduct a study of those DOT 

specimens reported to ODAPC as 

confirmed positive for 6–AM and 

negative for morphine. The scope of the 

study was ‘‘* * * to verify the atypical 

results obtained by the laboratories, to 

determine if other drugs or metabolites 

present in the specimen could explain 

the absence of morphine, and to 

determine if something other than 

heroin use could explain the presence of 

6–AM.’’ 1 The study consisted of 

aliquots (from the A bottles) of DOT 

specimens received by the laboratories 

between October and December 2010 

and reported by the laboratory to the 

MRO as confirmed positive for 6–AM 

and negative for morphine. 

The study reconfirmed the presence 

of 6–AM in all the specimens. By 

reconfirming the 6–AM results, the 

study confirmed ‘‘* * * that the 

presence of 6–AM in these specimens 

was not due to laboratory contamination 

or 6–AM production during analysis.’’ 

Morphine levels of >5ng/mL were also 

detected in all but 6 of the specimens. 

For these 6 specimens, the report went 

on to say that, ‘‘While atypical for 

heroin exposure and metabolism, the 

remaining 6 specimens’ results are 

consistent with literature reports of 

atypical 6–AM results after heroin 

exposure.’’ The authors determined that 

other drugs or metabolites present in the 

specimen were not responsible for the 

absence of morphine. Furthermore, the 

study concluded, ‘‘There was no 

evidence indicating that the 6–AM 

originated from a source other than 

heroin.’’ 2

Based upon these facts and researchbased conclusions, there is no longer a 

need for laboratories to detect the 

present of morphine below the HHS/ 

DOT established morphine cutoff of 

2000ng/mL and for MROs to confer with 

ODAPC on verifying these 6–AM 

results. Based on the RTI study, 

morphine may be present below the 

laboratory’s LOD. As we indicated in 

the preamble of the final rule [75 FR 

49856], for those specimens where 

morphine was not present we believe 

there is a scientific explanation. 

Therefore, we will amend 49 CFR 40.87 

and 40.97 to say that if the laboratory 

confirms a specimen as positive for 6– 

AM, and morphine is not at or above the 

2000ng/mL cutoff, the laboratory will 

report the specimen results to the MRO 

without any additional testing for 

morphine. We will also revise 49 CFR 

40.139 and remove section 40.140. 

Furthermore, the MRO will conduct the 

verification as he or she would for any 

other laboratory confirmed positive test 

result, with the understanding there is 

no legitimate explanation for the 

presence of 6–AM in the employee’s 

specimen regardless of the morphine 

result. 

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). 

Administrative Procedure Act 

The Department has determined this 

rule may be issued without a prior 

opportunity for notice and comment 

because providing prior notice and 

comment would be unnecessary, 

impracticable, or contrary to the public 

interest since this rule was thoroughly 

discussed in a prior final rule effective 

October 1, 2010 [75 FR 49850]. This rule 

will reduce the burden on laboratories 

and MROs since it will remove certain 

provisions of the drug testing regulation 

which currently require the laboratories 

and MROs to confer with each other and 

ODAPC regarding laboratory tests 

positive for 6–AM with no morphine at 

the laboratory’s LOD. It will also remove 

requirements for further laboratory 

testing where 6–AM is detected without 

the presence of morphine. 

Providing an opportunity for prior 

notice and comment before publishing 

this interim final rule (IFR) would be 

unnecessary since it is based upon a 

final rule [75 FR 49850, August 16, 

2010] that followed public notice and 

comment. In that rule we indicated we 

would determine what our first year of 

testing would reveal regarding the 

screening and confirmation testing of 6– 

AM and the presence of morphine. The 

first year has passed and from the 

information provided by the laboratories 

and MROs, and the collaborative 

scientific study with HHS, we learned 

morphine may be present below the 

laboratory’s LOD. In addition, for those 

few specimens where morphine was not 

present the study stated that such 

results were consistent with literature 

reports of atypical 6–AM results after 

heroin use. 

Providing an opportunity for notice 

and comment before publishing this IFR 

is also unnecessary since it makes only 

minor procedural and burden-relieving 

amendments to the rule text. 

Specifically, the rule will no longer 

require laboratories and MROs to 

consult with one another regarding the 

testing for the presence of morphine 

when the laboratory confirms the 


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Federal Register / Vol. 77, No. 87 / Friday, May 4, 2012 / Rules and Regulations 26473 

presence of 6–AM. In addition, 

laboratories and MROs will no longer be 

required to notify ODAPC of 6–AM only 

positive results. 

Executive Order 12866 and Regulatory 

Flexibility Act 

This Interim Final Rule is not 

significant for purposes of Executive 

Order 12866 or the DOT’s regulatory 

policies and procedures. The rule makes 

minor procedural amendments to its 

rule text. The rule will impose no new 

burdens on any parties, and will 

actually decrease the burden upon the 

laboratories and the MROs. The 

Department consequently certifies, 

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. 

Issued this 24th Day of April 2012, at 

Washington, DC. 

Ray LaHood, 

Secretary of Transportation. 

For reasons discussed in the 

preamble, the Department of 

Transportation amends Title 49 of the 

Code of Federal Regulations, Part 40, as 

follows: 

PART 40—PROCEDURES FOR 

TRANSPORTATION WORKPLACE 

DRUG AND ALCOHOL TESTING 

PROGRAMS 

■ 1. The authority citation for 49 CFR 

part 40 continues to read as follows: 

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

20140, 31306, and 54101 et seq. 

§ 40.87 [Amended] 

■ 2. In § 40.87 remove paragraph (e). 

§ 40.97 [Amended] 

■ 3. In § 40.97 remove paragraph (g). 

■ 4. Section 40.139 is revised to read as 

follows: 

§ 40.139 On what basis does the MRO 

verify test results involving opiates? 

As the MRO, you must proceed as 

follows when you receive a laboratory 

confirmed positive opiate result: 

(a) If the laboratory confirms the 

presence of 6-acetylmorphine (6–AM) in 

the specimen, you must verify the test 

result positive. 

(b) In the absence of 6–AM, if the 

laboratory confirms the presence of 

either morphine or codeine at 15,000 

ng/mL or above, you must verify the test 

result positive unless the employee 

presents a legitimate medical 

explanation for the presence of the drug 

or drug metabolite in his or her system, 

as in the case of other drugs (see 

§ 40.137). Consumption of food 

products (e.g., poppy seeds) must not be 

considered a legitimate medical 

explanation for the employee having 

morphine or codeine at these 

concentrations. 

(c) For all other opiate positive 

results, you must verify a confirmed 

positive test result for opiates only if 

you determine that there is clinical 

evidence, in addition to the urine test, 

of unauthorized use of any opium, 

opiate, or opium derivative (i.e., 

morphine, heroin, or codeine). 

(1) As an MRO, it is your 

responsibility to use your best 

professional and ethical judgement and 

discretion to determine whether there is 

clinical evidence of unauthorized use of 

opiates. Examples of information that 

you may consider in making this 

judgement include, but are not limited 

to, the following: 

(i) Recent needle tracks; 

(ii) Behavioral and psychological 

signs of acute opiate intoxication or 

withdrawal; 

(iii) Clinical history of unauthorized 

use recent enough to have produced the 

laboratory test result; 

(iv) Use of a medication from a foreign 

country. See § 40.137(e) for guidance on 

how to make this determination. 

(2) In order to establish the clinical 

evidence referenced in paragraphs 

(c)(1)(i) and (ii) of this section, personal 

observation of the employee is essential. 

(i) Therefore, you, as the MRO, must 

conduct, or cause another physician to 

conduct, a face-to-face examination of 

the employee. 

(ii) No face-to-face examination is 

needed in establishing the clinical 

evidence referenced in paragraph 

(c)(1)(iii) or (iv) of this section. 

(3) To be the basis of a verified 

positive result for opiates, the clinical 

evidence you find must concern a drug 

that the laboratory found in the 

specimen. (For example, if the test 

confirmed the presence of codeine, and 

the employee admits to unauthorized 

use of hydrocodone, you do not have 

grounds for verifying the test positive. 

The admission must be for the 

substance that was found). 

(4) As the MRO, you have the burden 

of establishing that there is clinical 

evidence of unauthorized use of opiates 

referenced in this paragraph (c). If you 

cannot make this determination (e.g., 

there is not sufficient clinical evidence 

or history), you must verify the test as 

negative. The employee does not need 

to show you that a legitimate medical 

explanation exists if no clinical 

evidence is established. 

§ 40.140 [Removed] 

■ 5. Remove § 40.140. 

[FR Doc. 2012–10665 Filed 5–3–12; 8:45 am] 

BILLING CODE 4910–9X–P 


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