  SEQ CHAPTER \h \r 1 Supporting Statement for a Request for OMB Review
under

The Paperwork Reduction Act

1	IDENTIFICATION OF THE INFORMATION COLLECTION

	1(a)	Title and Number of the Information Collection

		Title:	Notification of Substantial Risk of Injury to Health and the
Environment under TSCA Section 8(e)

		EPA ICR No.:    0794.12	OMB Control No.: 	2070-0046

	1(b)	Short Characterization

	Section 8(e) of the Toxic Substances Control Act (TSCA) states, “any
person who manufactures, [imports,] processes, or distributes in
commerce a chemical substance or mixture and who obtains information
which reasonably supports the conclusion that such substance or mixture
presents a substantial risk of injury to health or the environment shall
immediately inform the [EPA] Administrator of such information unless
such person has actual knowledge that the Administrator has been
adequately informed of such information” (15 U.S.C. 2607(e)).

	From January 1977 through June 2005, EPA received 16,063 initial
section 8(e) submissions covering a large number of chemical substances
and mixtures on a wide range of chemical toxicity/exposure information.
This includes approximately 10,500 submissions EPA received following a
1992 Compliance Audit Program, described below in Part 2(a).  Although
EPA’s receipt of section 8(e) information does not necessarily trigger
immediate regulatory action under TSCA or other authorities administered
by EPA, all section 8(e) submissions receive screening level evaluations
by EPA’s Office of Pollution Prevention and Toxics (OPPT) to identify
priorities for further Agency action and appropriate referrals to other
programs.

	OPPT routinely disseminates section 8(e) data to EPA’s Program and
Regional Offices and other federal agencies (e.g., NIOSH, OSHA, CPSC,
FDA, NTP) on newly discovered chemical hazards/risks.  Since June 2001,
OPPT has made these referrals primarily via e-mails of biweekly tables
summarizing all new section 8(e) submissions.  There is also public
outreach and information access to section 8(e) data through the TSCA
Public Docket and online data bases that include TSCA 8(e) records, as
well as through the TSCA 8(e) web page that includes all biweekly
reports of new 8(e) submissions back to June 2001 with PDF links to the
submissions.

2	NEED FOR AND USE OF THE COLLECTION

	2(a)  	Need/Authority for the Collection

	Section 8(e) of TSCA continues to be an important and useful tool for
early warning and identification of potential substantial risk
situations allowing EPA and others to focus their limited resources on
chemicals or mixtures of highest concern.  The submission of  section
8(e) information makes it possible for the Agency and others to learn
quickly about potential new chemical hazards/risks posed by exposure to
chemical substances, to conduct more complete assessments and, if
needed, effective action to eliminate or reduce such risks in a timely
manner.

	The statutory authority for this information collection is section 8(e)
of TSCA (U.S. Public Law 94-469; 90 Stat. 2029; 15 U.S.C. 2607(e)).  No
formal rule-making by the Agency was required to implement section 8(e),
in that section 8(e) was a self-activating reporting provision of TSCA
that became immediately effective on January 1, 1977 (the effective date
of the Act).  However, in order to facilitate compliance with section
8(e), EPA clarified the kinds of information that constitute substantial
risk information, specified the types of information exempt from the
reporting requirements, and outlined standard reporting procedures, in
published proposed guidance (42 FR 45362; September 9, 1977).  After
holding several public meetings and considering the public comments on
the proposed section 8(e) guidance, the Agency published its final
“Statement of Interpretation and Enforcement Policy; Notification of
Substantial Risk” (43 FR 11110; March 16, 1978).  In June 1991, EPA
published a “Section 8(e) Reporting Guide” to further assist the
regulated community in complying with section 8(e).  The 1991 Reporting
Guide references examples of  submitted information and EPA’s comments
on these submissions to help persons subject to section 8(e) better
understand the types of information that are reportable under section
8(e).  The 1991 Guide also includes dose ranges and exposure factors to
consider in determining the section 8(e) reportability of acute
lethality data.

	In February of 1991, the Agency initiated a voluntary section 8(e)
“Compliance Audit Program” (CAP).  This compliance program, which
followed several section 8(e) enforcement cases indicating that some
companies were not complying with section 8(e) reporting requirements,
was designed to 1) achieve EPA’s goal of obtaining any outstanding
section 8(e) data, and 2) provide maximum encouragement to companies to
voluntarily audit their files for section 8(e)-reportable information.
The section 8(e) CAP involved consent agreements/orders pursuant to
section 15 of TSCA, stipulated monetary penalties and an overall penalty
ceiling.  123 companies elected to participate voluntarily in the
Agency’s section 8(e) CAP activity.  The CAP was terminated on May 15,
1996 and settlements with CAP participants were announced on October 15,
1996.

	In implementing the section 8(e) CAP, EPA determined that there was a
need to suspend and refine those portions of the 1978 section 8(e)
Policy Statement that deal specifically with the reportability of
chemical releases to the environment and the detection of toxic
chemicals in environmental media.  On July 13, 1993 (58 FR 37735), EPA
published proposed guidance on the detection of toxic chemicals in
environmental media.  EPA received comments from 49 companies and
industry associations.  Based on the submitted comments and a number of
meetings with industry representatives, EPA revised the proposed
guidance and made it available for additional public comment through a
notice in the Federal Register published on March 20, 1995 (60 FR
14756).  In response, EPA received an additional 22 comments.  While the
comments offered additional refinements to the revised guidance, their
basic tenor was that industry was in support of the changes.

	Beginning in 1996, there was an ongoing collaboration between EPA and
industry to develop a question and answer (Q&A) document to promote
industry understanding of and compliance with the Agency’s anticipated
revised section 8(e) reporting criteria for environmental release and
contamination information.  The intent was to make the Q&A publicly
available before the revised guidance was published.  However, the
finalized Q&A document was not yet available when the revised guidance,
“TSCA Section 8(e); Notification of Substantial Risk; Policy
Clarification and Reporting Guidance” (68 FR 33129-33139), was
published on June 3, 2003.  The revised guidance included a
re-publication of the 1978 Policy Statement and incorporated revisions
that address the reporting of information on the release of chemical
substances to the environment and the detection of toxic chemicals in
environmental media.  Also included in the June 2003 Reporting Guidance
is a change in the deadline for reporting “substantial risk”
information to the Agency (from 15 working days to 30 calendar days) and
the circumstances under which certain information need not be reported
to EPA under section 8(e) of TSCA.  In a subsequent Federal Register
Notice, “TSCA Section 8(e) Reporting Guidance; Correction,
Clarification of Applicability, and Announcement Regarding the Issuance
(of) Questions and Answers” (70 FR 2162-2164), EPA announced certain
corrections to the June 2003 Reporting Guidance (due to transcription
errors from the 1978 Policy Statement that appeared in the June 2003
Guidance), stated that the applicability date for the June 2003 Guidance
Document was the publication date, and announced the availability on the
TSCA 8(e) web page (  HYPERLINK "http://www.epa.gov/oppt/tsca8e"
http://www.epa.gov/oppt/tsca8e ) of a Q&A document on the section 8(e)
reportability of releases of chemical substances to the environment and
the detection of toxic chemicals in environmental media.  This Q&A
document included only a few of the items drafted earlier by industry
stakeholders with EPA participation, but EPA will be adding Q&As to the
TSCA 8(e) web page on environmental releases and other aspects of
section 8(e) reporting following further comment and review.

	2(b)  	Use/Users of the Data

	Since 1977, the Agency and members of the chemical industry have
devoted significant efforts in fulfilling their respective
responsibilities under section 8(e).  Since January 1, 1977, 16,063
initial section 8(e) notices (includes CAP and non-CAP submissions)
covering a broad range of toxicity and exposure-related data on a wide
range of chemicals and chemical mixtures, have been received by the
Agency, screened, and received follow-up attention as needed.

	All incoming section 8(e) submissions are reviewed by EPA shortly after
receipt.  The initial processing of section 8(e) submissions includes a
screening level evaluation of the submitted data.  Such evaluations are
not risk assessments, nor do they consider other available toxicity data
on the chemical or exposure-related information on the chemical/mixture
being reviewed.  The results of screening level evaluations are used for
priority-setting to select cases for more detailed assessment, as well
as to identify referrals to other Offices and Agencies.

	EPA utilizes section 8(e) submission information for hazard/risk
identification purposes in the initial stages of the TSCA chemical
screening and review program.  Section 8(e) data are also used in
ongoing EPA hazard and exposure assessments of both existing and new
chemicals, in the SIDS international testing program, in the High
Production Volume (HPV) Challenge Program, and in support of regulation
development under TSCA, e.g., development of chemical testing rules
under section 4 of TSCA, as well as regulation development under other
authorities administered by the Agency.  In addition, section 8(e)
submissions have been the basis for chemical advisories to communicate
potential health risks and the need for exposure controls, as well as
for chemical summaries to identify data availability for chemical hazard
and exposure assessment.

	Regardless of the type of section 8(e) follow-up action or activity
taken, all reported information not claimed as TSCA confidential
business information is made available to other EPA Program and Regional
Offices, other federal agencies and others (e.g., chemical industry,
trade unions, environmental groups, general public, and the
international community) that may be interested in the subject chemical
or mixture.  EPA offices and other federal agencies routinely utilize
section 8(e) data in implementing their regulatory programs.  The
principal vehicles for making the information publicly available are the
TSCATS data base, the TSCA Docket, and the TSCA section 8(e) web page at
  HYPERLINK "http://www.epa.gov/opptintr/tsca8e"
http://www.epa.gov/opptintr/tsca8e .  The TSCA 8(e) web page includes
all published section 8(e) guidance and full text copies of all new
section 8(e) submissions.

	EPA’s proactive implementation of section 8(e) has also resulted in
heightened corporate awareness of the potential risk of injury posed by
exposure to chemical substances.  This increased corporate awareness has
led to a variety of voluntary corporate actions designed to protect
human health and/or the environment.  Many companies have reported to
EPA that the following types of risk reduction/pollution prevention
measures were initiated in direct response to the submitted chemical
toxicity and/or exposure data:

Notification of workers, customers and others;

Revision of product labels and Material Safety Data Sheets;

Modification of manufacturing, processing, and/or handling;

Ceasing production/use either temporarily or permanently;

Initiation of additional toxicity or exposure studies to further define
potential risks.

3	NON-DUPLICATION, CONSULTATIONS AND OTHER COLLECTION CRITERIA

	3(a)  	Non-Duplication

	There is no other source of data that can be used in place of the data
submitted to EPA under the section 8(e) statutory reporting requirement.
 The “substantial risk” information required to be reported to EPA
is unpublished information not already known to the Agency.  In
addition, information need not be submitted under section 8(e) if the
information has been reported already to EPA pursuant to another
mandatory information reporting requirement of TSCA or some other
authority administered or delegated to the States by EPA.  In the June
3, 2003 Reporting Guidance, the Agency clarified the circumstances under
which certain information need not be reported to EPA under section 8(e)
of TSCA.  This is expected to result in some additional reduction of the
overall respondent reporting burden for section 8(e).

	3(b)  	Public Notice Required Prior to ICR Submission to OMB

	  SEQ CHAPTER \h \r 1    SEQ CHAPTER \h \r 1 In proposing to renew this
ICR, EPA provided a 60-day public notice and comment period that ended
on April 14, 2009 (  SEQ CHAPTER \h \r 1 74 FR 7227, February 13, 2009).
   SEQ CHAPTER \h \r 1 EPA received comments from BASF Corp.  These
comments are addressed in Attachment 2.

	3(c) 	Consultations

	EPA personnel have participated in numerous public meetings and other
fora to discuss the section 8(e) Policy Statement and the Agency’s
implementation of section 8(e).  Large EPA-sponsored public meetings at
which section 8(e) was a primary topic of discussion were held in 1978,
1986, 1987, 1990 and 1992 with chemical industry representatives and
other interested parties.  EPA staff also met on numerous occasions with
members of the chemical industry to discuss section 8(e) in the context
of the section 8(e) Compliance Audit Program.  In addition, EPA staff
have participated in more than 30 industry-sponsored meetings at which
section 8(e) of TSCA was the major or primary topic of discussion.

	EPA proposed amendments to the section 8(e) policy statement in 1993
and again in 1995.  The proposed amendments dealt specifically with
clarifications on reporting requirements for occurrences of
environmental exposure or contamination.  The Agency received numerous
public comments on these proposed amendments and developed a “Comment
and Response Document for Revised Policy Statement of Section 8(e) of
TSCA” (OPPT-2002-0067-0002) to record these comments and the
Agency’s responses (see Attachment 3).  EPA has also collaborated with
industry in preparing a question and answer document dealing with
revisions to the 1978 Policy Statement and from 1994 to the present
section 8(e) has been on the agenda of the “Living with TSCA”
conferences held annually for all TSCA stakeholders.

	  SEQ CHAPTER \h \r 1    SEQ CHAPTER \h \r 1 Additionally, under 5 CFR
1320.8(d)(1), OMB requires agencies to consult with potential ICR
respondents and data users about specific aspects of ICRs before
submitting an ICR to OMB for review and approval.  In accordance with
this regulation, EPA submitted questions to nine parties via e-mail.
The individuals contacted were:

Janet Cerra

BASF

<EMAIL_ADDRESS>
Betsy Duncan

Lyondell Chemical Company

<EMAIL_ADDRESS>
Michael Hulse

Shell Chemical LP

<EMAIL_ADDRESS>
Judith L. Kranetz

Rhodia Inc.

<EMAIL_ADDRESS>
Deanna J. Luebker, Ph.D.

3M

<EMAIL_ADDRESS>
Marie Paquette

Ciba Specialty Chemical North America

<EMAIL_ADDRESS>
Debra Randall

Arkema Inc.

<EMAIL_ADDRESS>
Nancy Sandrof

American Chemistry Council

<EMAIL_ADDRESS>
Karluss Thomas

Silicones Environmental, Health and Safety Council of North America

<EMAIL_ADDRESS>
	EPA received no responses to its solicitation for consultations.  A
copy of EPA’s consultation e-mail to the above potential respondents
is in Attachment 3.

	3(d)  	Effects of Less Frequent Collection

	TSCA section 8(e) reporting is not cyclical, but rather is
self-implementing.  The statute states that persons covered under the
section 8(e) reporting requirement shall immediately notify the EPA
Administrator upon obtaining reportable information.  As stated
previously, section 8(e) continues to be an extremely important and
useful EPA tool for early identification of potential substantial risk
situations and allows the Agency as well as others to focus their
resources on those chemicals or mixtures of highest concern.  The
consequences of EPA not receiving section 8(e) data immediately
following receipt by a respondent are serious.  The Agency would be
prevented from learning about and publicizing new information about
substantial risks to health or environmental injury posed by exposure to
chemical substances and/or mixtures.  Further, EPA would not be in a
position to adequately assess and, if necessary, take action to
effectively eliminate or reduce such risks in an expeditious manner.

	3(e)  	General Guidelines

	The required reporting that takes place under section 8(e) does not
appear to exceed the Paperwork Reduction Act-imposed guidelines that are
found at 5 CFR 1320.6.

	3(f)  	Confidentiality

	Any person submitting a notice to EPA under section 8(e) may assert a
claim of business confidentiality covering information contained in the
submission.  Any information covered by a claim will be disclosed by EPA
only to the extent and by means of the procedures set forth at 40 CFR
Part 2.  If no confidentiality claim accompanies a section 8(e) notice,
the submission is placed in the TSCA Docket and is available to the
public without further notice to the submitting organization.  The
Agency has established and actively implements well-publicized standard
procedures for the handling and safeguarding of information claimed as
TSCA Confidential Business Information (TSCA CBI).

	3(g)  	Sensitive Questions

	Under section 8(e), EPA does not seek submission of information with
regard to sexual behavior or attitudes, religious beliefs, or other
matters usually considered to be of a private nature.

4	RESPONDENTS AND THE INFORMATION REQUESTED

	4(a)  	Respondents/NAICS Codes

	A statutory section 8(e) reporting obligation can be incurred by any
person who manufactures, imports, processes or distributes a
TSCA-covered chemical substance or mixture.  EPA’s section 8(e) Policy
Statement defines the term “person” broadly to include “any
natural person, corporation, firm, company, joint-venture, partnership,
sole proprietorship, association, or any other business entity, any
State or political subdivision thereof, any municipality, any interstate
body and any department, agency, instrumentality of the Federal
Government.”  Although this definition is quite broad in terms of
subject persons, section 8(e) reporting obligations are most typically
incurred by companies engaged in activities classified by NAICS Codes
325 - Chemicals and Allied Products Manufacturers and 32411- Petroleum
Refining.

	4(b)  	Information Requested

	(i)  	Data Items

	There is no required collection instrument or reporting form on which
section 8(e) information must be submitted to EPA; however, the section
8(e) Policy Statement requires all respondents to ensure that a written
section 8(e) notice:

is sent to EPA by a method verifying the Agency’s receipt;

states that it is being submitted under section 8(e) of TSCA;

contains the name, address, job title, phone number and signature of the
person reporting, and the name and address of the establishment with
which the person is associated;

identifies the chemical substance(s) or mixture including, if known, the
Chemical Abstract Service (CAS) Registry Number(s);

summarizes adverse health/environmental effects being reported including
a description of the nature and extent of the risk; and

contains the specific source/summary of the supporting data.

	EPA is continuing its efforts to implement optional electronic
reporting of section 8(e) submissions to increase processing efficiency
for both the Agency and the regulated community.

	(ii) 	Respondent Activities

	The overall purpose of section 8(e) reporting is to ensure that new
information that reasonably supports a conclusion that a chemical
substance or mixture presents a “substantial risk” of injury to
health or the environment is brought to EPA’s attention immediately
upon discovery.  It should be noted again that section 8(e) applies to
all chemical manufacturers, importers, processors, and distributors and
applies also to information that a subject person possesses or about
which that person has knowledge.  Although compliance with section 8(e)
does not require subject persons to search for information or to make
extraordinary efforts to acquire information, section 8(e) does apply to
information that is “obtained” (i.e., information that a person
possesses or about which that person knows).  Following a review of
existing information and a decision that such information is of the type
required under section 8(e), respondents must notify EPA in writing
immediately.  EPA’s June 2003 Reporting Guidance defines the term
“immediately” in the context of written section 8(e) reports to mean
within 30 calendar days of the date on which the information was
obtained; the immediate reporting of an emergency incident of
environmental contamination by a toxic substance is defined as a phone
report to EPA or to the National Response Center as soon as a person
knows about the incident.

5	INFORMATION COLLECTION - EPA ACTIVITIES, COLLECTION METHODOLOGY AND
INFORMATION MANAGEMENT

	5(a)  	Agency Activities

	As explained in additional detail in the following sections, the
Agency’s section 8(e) activities involve answering general and
specific section 8(e)-related questions, development and maintenance of
computerized information tracking (including data extraction, entry and
quality assurance/control), microfilming, confidential
(restricted-access) and non-confidential (public-access) section 8(e)
information filing, initial evaluation of all submitted section 8(e)
information (including review of TSCA Confidential Business Information
(CBI) substantiations), and the posting of section 8(e)-related
information on the Internet for public access.

	5(b)  	Collection Methodology and Information Management

	EPA uses Document Control Numbers (DCNs) to identify TSCA submissions;
section 8(e) has the following format: 88-YYXXXXXXX.  The assigned
7-digit ascending numbers begin each year with 0000001.  EPA also
identifies section 8(e) submissions by 8EHQ Numbers, which are
chronological from January 1977.  The format is 8EHQ-MMYY-XXXXX.
Initial submissions are assigned as Sequence A; supplemental and
follow-up submissions are assigned Sequence B, C, D, etc.  Internal EPA
tracking of section 8(e) submission information is handled via
non-confidential and confidential computerized data bases.

	In order to assure that the public is kept apprised of new adverse
chemical-related toxicity and exposure information, the Agency provides
public access to and actively disseminates non-confidential section 8(e)
submission information in many ways.  Examples of EPA’s public
access/outreach activities follow.

	Non-confidential section 8(e) initial and follow-up/supplemental
submissions, status reports, submission summaries, and EPA follow-up
letters can be viewed/copied in the TSCA Public Docket located at EPA
Headquarters.  Non-confidential section 8(e)-related documents can also
be obtained by writing to EPA’s Freedom of Information Office.

	Relevant non-confidential information from section 8(e) submissions is
routinely entered into TSCATS (Toxic Substances Control Act Test
Submissions), a publicly available computerized data base that serves as
an on-line index of unpublished health and safety studies submitted to
EPA under TSCA.  The most recent version of the TSCATS data base is
available on the web at   HYPERLINK
"http://yosemite.epa.gov/oppts/epatscat8.nsf/ReportSearch?OpenForm"
http://yosemite.epa.gov/oppts/epatscat8.nsf/ReportSearch?OpenForm .  The
submitted studies themselves are stored and available on microfiche.
Microfiche copies of the studies referenced in the TSCATS data base are
available from either CIS or the National Technical Information Service
(NTIS) in Springfield, VA.  EPA has also been creating full electronic
(PDF) copies of all new section 8(e) submissions since June 2001.
Electronic copies of these most recent section 8(e) submissions are
available to the public from the TSCA Public Docket, as well as from the
section 8(e) web site at   HYPERLINK "http://www.epa.gov/oppt/tsca8e"
http://www.epa.gov/oppt/tsca8e .

	Under established Freedom of Information Act (FOIA) procedures, EPA
responds to requests from industry, other stakeholders and the public.
In cooperation with the Organization for Economic Cooperation and
Development’s (OECD) information-gathering “Switchboard” project,
EPA responds as well to international requests for section 8(e) and
other unpublished health and safety data on chemicals of concern to OECD
members.

	As stated previously, EPA routinely notifies other federal agencies on
incoming section 8(e) information via biweekly tabular reports of new
section 8(e) submissions and by targeted referrals.  As the direct
result of these public outreach activities, several of these other
agencies actively publicize the information even further.  For example,
the National Library of Medicine (NLM) at the National Institutes of
Health makes section 8(e) information available via its publicly
available computerized Hazardous Substances Data Bank (HSDB) and Toxline
data bases.  In addition, the National Institute for Occupational Safety
and Health (NIOSH) cites section 8(e) notices in the printed and on-line
computerized versions of the “Registry of Toxic Effects of Chemical
Substances” (RTECS) data base.

	5(c)  	Small Entity Flexibility

	The statutory obligation to report information under section 8(e) of
TSCA applies to all manufacturers, importers, processors, and/or
distributors of TSCA-covered chemical substances and mixtures.  The
statutory language of section 8(e) itself does not allow for any
reporting exemption or burden minimization based on the size or earnings
of a respondent.  However, nearly all reporting is by large and medium
size companies.  This is mainly because only larger companies have the
financial resources to conduct toxicity testing that comprises most
section 8(e) reporting.  Since there is no routine reporting or
recordkeeping provisions for section 8(e), the true burden on most small
entities is practically nonexistent.

	5(d)  	Collection Schedule

	Considering that section 8(e) submissions are received by the Agency on
an ad hoc basis, there is no standard reporting cycle.  Submitters are
required to comply with section 8(e) immediately when they come into
possession of or know about section 8(e)-reportable information.  If
section 8(e) information were not made available immediately to EPA, the
Agency’s ability to learn about, publicize, effectively assess, and
respond appropriately to newly discovered chemical-related risks would
be severely impeded, if not completely thwarted.

6	ESTIMATING THE BURDEN AND COST OF COLLECTION

	For the current ICR renewal, EPA utilized data on the number of section
8(e) submissions for fiscal years FY 2006-2008.  The averaged annual
number of initial 8(e) submissions was 390 (418+379+373=1170/3). The
averaged annual number of supplemental and follow-up 8(e) submissions
was 136 (123+132+154=409/3).

	In the previous ICR renewal, it was determined that for initial section
8(e)s,  submission equivalents were also estimated to account for the
need to review data that are not ultimately submitted as TSCA 8(e).  For
initial section 8(e)s, the number of submission equivalents is used
instead of the number of actual submissions.  Estimating that the number
of cases not submitted is 50% of the number of cases submitted, the
number of initial section 8(e) submission equivalents per year for FY
2006-2008 is increased from 390 to 585 (390 x 1.5).

	6(a)  	Estimating Submitter Burden

	The following discussion provides the basis for the Agency’s
upper-bound estimate of approximately 30,515 total hours of annual
reporting burden for submitters in complying with section 8(e).

	EPA believes that it should take approximately 49 hours per submission
to judge and concur on the section 8(e)-applicability of obtained
information plus 2 additional hours to prepare/submit the necessary
information.  The first figure is based on an average of 45 hours per
submission of managerial and technical staff time to review and evaluate
data and an additional 4 hours for staff training on TSCA 8(e)
regulatory requirements.  An additional 2 hours per submission reflects
general clerical support.  Using the calculated average of 585 initial
section 8(e) submission equivalents per year, the total number of hours
required for initial section 8(e) reporting is estimated to be 29,835
(585 x 51) hours.

INITIAL SUBMISSIONS SUBTOTAL

Burden Item	Hours/Submitter	Submissions/Year	Hours/Year

Managerial/technical review, data evaluation, decision-making,
concurrence and drafting an initial section 8(e) submission

49

585

28,665

General clerical support (typing, copying and transmitting an initial
section 8(e) submission)

2

585

   1,170

51

585

29,835

	Considering that the respondent’s decision-making/concurrence
activities for determining section 8(e)-applicability/reportability has
already taken place with the initial submission, the Agency views the
activities surrounding the submission of follow-up/supplemental
information in response to EPA questions on the initial section 8(e)
submission, or as a result of further investigation/evaluation by the
company, as being less burdensome. The submission of
follow-up/supplemental information is estimated to be 5 hours per
notice, assuming 3 hours to assemble the required information, 1 hour
for management review, and 1 hour to prepare and transmit the
submission.  Using the calculated average of 136 follow-up/supplemental
submissions per year, the total number of hours required for
follow-up/supplemental section 8(e) reporting is estimated to be 680
(136 x 5) hours.

FOLLOW-UP AND SUPPLEMENTAL SUBMISSIONS SUBTOTAL

Burden Item	Hours/Submitter	Submissions/Year	Hours/Year

Managerial/ technical review, concurrence and drafting a follow-up/
supplemental section 8(e) submission.

4

136

544

General clerical support (typing, copying and transmitting a follow-up/
supplemental section 8(e) submission)

1

136

  136

5

136

680

	In summary, the total number of section 8(e) initial submission
equivalents plus follow-up/supplemental submissions is 721 (585 + 136)
submissions per year.  Based on the figures presented in the preceding
tables, the total submitter burden (in hours/year) for initial and
follow-up/supplemental section 8(e) submissions to EPA is as follows:

TOTAL HOURLY BURDEN/YEAR

     Initial				Follow-Up/Supplemental			Total

Submissions		+		          Submissions          	=	       Hours/Year

29,835 hours/year	+		       680 hours/year		=		30,515

	6(b)  	Estimating Submitter Costs

	EPA estimates that a respondent incurs costs up to $69.21/hour in
managerial/technical labor costs and $27.59/hour in clerical labor costs
in submitting information to EPA under section 8(e). These hourly costs
take into account the involvement of the respondent’s managerial,
technical and clerical personnel and takes into account standard labor
wage rates (including fringe benefits) using Bureau of Labor Statistics
(BLS) wage rates for the Private Manufacturing industries adjusted for
the year 2007. It should be noted that section 8(e) reporting does not
involve operating/maintenance or capital costs to the respondent.  The
hourly labor wage rates used in the computations appear below.

Hourly Labor Rates *

			Labor Category			Hourly Rate

			Managerial				$ 69.21

			Technical				$ 55.42

			Clerical				$ 27.59

			EPA staff				$ 68.99

*See Appendix A for derivations

	Based on the total estimated reporting burden of 30,515 hours/year and
the hourly labor rates listed above, the annual cost for submitters to
comply with section 8(e) is estimated to be $2,057,588 as follows.

TOTAL ANNUAL COSTS

Burden Item

Submitter Hours/Year (Initial)

Submitter Hours/Year (Supplemental)

Total Hours/Year	Wage Rate	Total Cost/Year

Managerial/technical review, data evaluation, decision-making,
concurrence and drafting a section 8(e) submission

28,665

544

29,209	$69.21/hr	$2,021,555

General clerical support (typing, copying, and sending a section 8(e)
submission

1,170

136

1,306	$27.59/hr	$36,033

$2,057,588

	6(c) 	Estimating EPA Burden and Costs

	Based on reasonable costs for reports received by EPA as the result of
general section 8 rule-making activities, EPA estimates the cost per
submission can range from $275 to $900. This assumes that it takes a
GS-13 Step 5 staff member between 4 and 13 hours to process, copy, file,
and initially review and/or answer questions on each section 8(e)
submission (4 * $68.99 and 13 * $68.99). Therefore, EPA estimates its
total annual cost for these activities involving 721 incoming section
8(e) submissions (585 initial plus 136 follow-up/supplemental notices
per year) to range from $198,275 - $648,900 per year as follows:

EPA BURDEN/COSTS

Initial/Follow-Up/Supplemental		 Cost of EPA			   Total

       Submissions per Year        	x      Processing/ Review	=
Cost/Year

       721 submissions/year		x      $275-$900/Submission	=  $198,275 -
$648,900/year

	6(d) 	Bottom Line Burden Hours and Costs

(i) 	Submitters’ Annual Burden (Hours and Costs)

		(a) 	Hours

		Initial Section 8(e) Submissions

		51 hours x 585 submissions = 29,835 hours

		Follow-up/Supplemental Section 8(e) Submissions

		5 hours x 136 submissions = 680 hours

		Submitters’ Total Annual Hourly Burden

		29,835 hours + 680 hours = 30,515 hours

		(b) 	Costs

		Submitters’ Total Annual Cost

		29,209 managerial hours x $69.21/hour = $2,021,555

1,306 clerical hours x $27.59/hour = $36,033

$2,021,555 + $36,033 = $2,057,588

	(ii)	 EPA’s Annual Burden/Cost

		Initial Section 8(e) Submissions

		585 submissions x $275-$900/submission = $160,875 - $526,500

		Follow-up/Supplemental Section 8(e) Submissions

		136 submissions x $275-$900/submission = $37,400 - $122,400

		EPA’s Total Annual Estimated Burden/Cost

		721 submissions x $275-$900/submission = $198,275 - $648,900

	6(e)	Reasons for Change in Burden

	There is an increase of 12,380 hours (from 18,135 hours to 30,515
hours) in the total estimated respondent burden compared with that
identified in the information collection request most recently approved
by OMB.  This increase in burden hours is primarily due to an increase
in submissions for the following reasons. First, there has been
increased awareness and therefore enforcement of the submissions. With
the High Production Volume Challenge Program, the public has the right
to know information on the hazard of certain chemicals. Data from the
8(e) submissions are often used for this program. Companies have also
been submitting information on chemicals to assure that there is no
enforcement action taken upon the companies due to the Chemical
Assessment and Management Program (ChAMP), which reviews chemicals on
the Toxic Release Inventory.

	The estimate in submitter annual costs associated with this ICR is
higher than the previous section 8(e) ICR because of the above
considerations as well as the increased hourly labor rates. The previous
estimate was based on a simpler BLS data series whereas the current ICR
uses an overhead rate of 17% based on assumptions in Wage Rates for
Economic Analyses of the Toxics Release Inventory Program (Rice, 2002)
and the Revised Economic Analysis for the Amended Inventory Update Rule:
Final Report (EPAB, 2002). 2007 is the most recent year for which wage
rates were available not subject to revision by BLS.

	6(f)  	Burden Statement

	The annual public burden for this collection of information, which is
approved under OMB Control No. 2070-0046, is estimated to average 51
hours per initial section 8(e) submission and 5 hours per
follow-up/supplemental section 8(e) submission.  According to the
Paperwork Reduction Act, “burden” means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
or disclose or provide information to or for a federal agency.  For this
collection, it includes the time needed to: review instructions;
disclose and provide information; adjust existing procedures to comply
with any previously applicable instructions and requirements; train
personnel to respond to a collection of information; complete and review
the information collection; and transmit or otherwise disclose the
information.  An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays a
currently valid OMB control number.  The OMB control number for this
information collection appears above.  In addition, the OMB control
numbers for EPA’s regulations, after initial display in the final
rule, are listed in 40 CFR part 9.

	To comment on the Agency’s need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for this ICR under Docket ID No.
EPA-HQ-OPPT-2008-0896.   SEQ CHAPTER \h \r 1 The docket is available for
public viewing at the Pollution Prevention and Toxics Docket in the EPA
Docket Center (EPA/DC). The EPA/DC Public Reading Room is located in the
EPA West Building, Room 3334, 1301 Constitution Ave., NW., Washington,
DC. The EPA/DC Public Reading Room is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal holidays. The telephone number
for the EPA/DC Public Reading Room is<PHONE_NUMBER>, and the telephone
number for the Pollution Prevention and Toxics Docket is<PHONE_NUMBER>.
An electronic version of the public docket is available through the
Federal Docket Management System (FDMS) at     HYPERLINK
"http://www.regulations.gov"  www.regulations.gov . Use FDMS to submit
or view public comments, access the index listing of the contents of the
public docket, and to access those documents in the public docket that
are available electronically. Once in the system, select “search,”
then key in the docket ID number identified above. Also, you can send
comments to the Office of Information and Regulatory Affairs, Office of
Management and Budget, 725 17th Street, NW, Washington, DC 20503,
Attention: Desk Office for EPA.  Please include the EPA Docket ID No.
EPA-HQ-OPPT-2008-0896 and OMB control number 2070-0046 in any
correspondence.

APPENDIX A

WAGE RATES

WAGE RATES

This appendix describes the derivation of the fully loaded labor rates
used in calculating costs of labor. Costs for this report are for
year-end 2007.

A.1 	Derivation of Loaded Wage Rates

Unit labor costs are calculated by adding fringe benefits and overhead
to the wage or salary to derive a fully loaded labor cost. The basic
method is described in Wage Rates for Economic Analysis of the Toxics
Release Inventory Program (Rice, 2002). The resulting loaded labor rates
are given in   REF _Ref201659447 \h  \* MERGEFORMAT  Table A-1 . Costs
are calculated for several labor categories: Managerial, Professional/
Technical, Clerical, and EPA staff.

A.1.1 Derivation of Labor Rates for Managerial, Professional/Technical,
and Clerical Labor

	Wages and fringe benefits for managerial, professional/technical, and
clerical labor were taken from the Bureau of Labor Statistics (BLS)
Employer Costs for Employee Compensation (ECEC) data, for December, for
manufacturing industries.

	The cost of fringe benefits such as paid leave and insurance, specific
to each labor category, are taken from the same ECEC series. Fringe
benefits as a percent of wages are calculated separately for each labor
category. For example, for December 2007, the average wage rate for
professional/technical labor was $33.14; the average fringe benefit was
$16.65. Fringe benefits as a percent of wages were $16.65/$33.14, or
approximately 50.2 percent.

An additional loading factor of 17 percent is applied to wages to
account for overhead. This approach is used for consistency with Office
of Pollution Prevention and Toxics economic analyses for two major
rulemakings: Wage Rates for Economic Analyses of the Toxics Release
Inventory Program (Rice, 2002) and the Revised Economic Analysis for the
Amended Inventory Update Rule: Final Report (EPAB, 2002). This overhead
loading factor is added to the benefits loading factor, and the total is
then applied to the base wage to derive the fully loaded wage. For
example, the December 2007 fully loaded wage for professional/technical
labor is $33.14 × (1+0.502414 + 0.17) = $55.42.

Fully loaded costs for managerial and clerical labor are calculated in a
similar manner, as shown in   REF _Ref201659447 \h  \* MERGEFORMAT
Table A-1 .

A.1.2 Derivation of Labor Rates for EPA Staff

Agency labor costs are calculated based on annual federal salaries for
the Washington-Baltimore area published by the Office of Personnel
Management effective January 2007 (OPM, 2007). The average salary for
one Full Time Equivalent (FTE) staff is estimated as the salary for a
GS-13 Step 5 employee.

Multiplying the annual pay by an assumed loading factor of 1.6 to
reflect federal fringe benefits and overhead, the loaded annual salary
of EPA staff was calculated to be $143,976.

The Agency loading factor is from an EPA guide, Instructions for
Preparing Information Collection Requests (ICRs) (OPPE, 1992, page 30,
footnote 9). The 60 percent assumption was labeled “the benefits
multiplication factor” in the EPA Guide, but has been used in many EPA
Office of Pollution Prevention and Toxics ICRs to reflect both fringe
benefits and overhead for federal staff. For example, it was used in an
August 2000 document supporting ICR No. 1139.06, with the following
explanation:

“The annual costs per FTE are derived by multiplying the annual pay
rate by 1.6 (the benefits multiplication factor). The multiplication
factor used is recommended in EPA's Office of Policy, Planning, and
Evaluation's Instructions for Preparing Information Collection Requests
(ICRs) (June 1, 1992). An EPA internal phone call between Carol Rawie
(OPPT/EETD/RIB) and Carl Koch (OPPE/RMD/IMB) on May 3, 1994, indicated
that the 1.6 factor included not only benefits but also overhead.”
(ICR No.1139.06)Table A-  SEQ Table_B- \* ARABIC  1  Derivation of
Loaded Wage Rates

EPAB Labor Category	Data Sources	Date

 	Wage	Fringe Benefit	Fringes as % wage	Over-head % wage1	Fringe +
overhead factor	Loaded Wages

	(a)	(b)	(c) =(b)/(a)	(d)	(e)=(c)+(d)+1	(f)=(a) x (e)

Managerial	BLS ECEC, Private Manufacturing industries, “Mgt, Business,
and Financial”2	Dec-07	$41.93 	$20.15 	48.06%	17%	1.65	$69.21

Professional/

Technical	BLS ECEC, Private Manufacturing industries, “Professional
and related“2	Dec-07	$33.14 	$16.65 	50.24%	17%	1.67	$55.42

Clerical	BLS ECEC, Private Manufacturing industries, “Office and
Administrative Support” 2	Dec-07	$16.47 	$8.32 	50.52%	17%	1.68	$27.59

EPA staff FTE	Annual federal staff cost: OPM
Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV, area, GS-13 Step
5 pay rates, with 60% overhead. 3	Jan-07	$89,985/year

$43.12/hour	--	[Included in 60% overhead]	60%	1.6	$143,976/year

$68.99/hour

Notes:

1An overhead rate of 17% was used based on assumptions in Wage Rates for
Economic Analyses of the Toxics Release Inventory Program (Rice, 2002),
and the Revised Economic Analysis for the Amended Inventory Update Rule:
Final Report (EPAB, 2002).

2Employer Costs for Employee Compensation Supplementary Tables: December
2007, US Bureau of Labor Statistics, March 12, 2008 (BLS, 2008a).

3The federal salary is the unloaded federal GS-13 Step 5 salary for
calendar 2007, from the Office of Personnel Management salary table for
Washington-Baltimore-Northern Virginia (OPM, 2007). The 60%
fringes-and-overhead rate is from an EPA guide, Instructions for
Preparing Information Collection Requests (ICRs) (OPPE, 1992, page 30,
footnote 9).

APPENDIX A REFERENCES

BLS, 2008a.  U.S. Bureau of Labor Statistics. Employer Costs for
Employee Compensation Supplementary

 Tables: December 2007 (March 12, 2008) at   HYPERLINK
"http://www.bls.gov/ncs/ect/sp/ecsuptc5.pdf"
http://www.bls.gov/ncs/ect/sp/ecsuptc5.pdf

EPAB, 2002. U.S. EPA, Office of Pollution Prevention and Toxics,
Economic and Policy Analysis Branch. Revised Economic Analysis for the
Amended Inventory Update Rule: Final Report. Washington, DC. August
2002.

ICR No. 1139.06. [Information Collection Request for] TSCA Existing
Chemical Test Rules, Consent Orders, Test Rule Exemptions, and Voluntary
Test Data Submissions: Supporting Statement for Request for OMB Review
under the Paperwork Reduction Act. Attachment 5, Wage Rates Estimation,
August 29, 2000.

OPPE, 1992. U.S. EPA, Office of Policy, Planning, and Evaluation.
Instructions for Preparing Information Collection Requests (ICRs).
Washington, DC, June 1, 1992.

OPM, 2007. Office of Personnel Management, Salary Table 2007-DCB,
Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV. Accessed from
HYPERLINK "http://www.opm.gov/oca/07tables/html/dcb.asp"
http://www.opm.gov/oca/07tables/html/dcb.asp

Rice, 2002. Cody Rice. Wage Rates for Economic Analysis of the Toxics
Release Inventory Program. Washington, DC: U.S.EPA, Office of Pollution
Prevention and Toxics, Economic and Policy Analysis Branch, June 10,
2002.

 Employer Costs for Employee Compensation Supplementary Tables for
December 2007 (BLS, 2008a).

 PAGE

 PAGE   - 15 -

  PAGE  - 15 -

	A-  PAGE  2

Economic Analysis of Expedited SNURs, Docket OPPT-2008-251
                  B-  PAGE  4                                       July
2, 2008

A-  PAGE  3

Economic Analysis of Expedited SNURs, Docket OPPT-2008-251	B-  PAGE  2
July 2, 2008

	A-  PAGE  4


[Federal Register Volume 77, Number 77 (Friday, April 20, 2012)]
[Notices]
[Pages 23794-23797]
[FR Doc No: 2012-9555]

-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA-2012-0102]

Proposed Recommendations on Obstructive Sleep Apnea

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice; request for public comments.

-----------------------------------------------------------------------

SUMMARY: FMCSA announces proposed recommendations from the Motor
Carrier Safety Advisory Committee (MCSAC) and the Medical Review Board
(MRB) on Obstructive Sleep Apnea (OSA) and the medical certification of
commercial motor vehicle (CMV) drivers. The MCSAC and the MRB are FMCSA
advisory committees and operate in accordance with the Federal Advisory
Committee Act (FACA). At the Agency's request, the committees
deliberated and provided their finalized recommendations to FMCSA on
February 6, 2012. The Agency proposes to adopt the recommendations as
regulatory guidance after reviewing and evaluating comments received
from the public.

DATES: Comments must be received on or before May 21, 2012.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA 2012-0102 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket numbers for this notice. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading below
for further information.
    Docket: For access to the docket to read background documents or

comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgment page that appears after submitting comments
on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the FDMS published in
the Federal Register on January 17, 2008 (73 FR 3316), or you may visit
http://edocket.access.gpo.gov/2008/pdf/E8-785.pdf.

FOR FURTHER INFORMATION CONTACT: Angela Ward, Nurse Consultant Medical
Programs,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Department of
Transportation, 1200 New Jersey Avenue SE., Room W64-224, Washington,
DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m., Monday
through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    49 CFR 391.41(b)(5) provides that a person is qualified physically
to drive a CMV if that person has no established medical history or
clinical diagnosis of a respiratory dysfunction likely to interfere
with the ability to control and drive a CMV safely.
    The Instructions to The Medical Examiner on the Medical Examination
Report, (49 CFR 391.43), identifies OSA as one of several respiratory
dysfunctions that may be detrimental to safe driving as this condition
may interfere with driver alertness and may cause gradual or sudden
incapacitation.
    FMCSA directed its two advisory committees, the MCSAC and the MRB,
meet jointly and publically to deliberate on the topic of OSA and
whether CMV drivers with OSA should be medically certified.
    FMCSA tasked the MCSAC and the MRB with jointly providing
information, concepts, and ideas the Agency should consider in
developing regulatory guidance for motor carriers, CMV drivers, and
medical examiners on OSA and whether drivers with this condition should
be medically certified to operate CMVs in interstate commerce. FMCSA
instructed the MCSAC and MRB to provide information about how to
address drivers with OSA in the short-term until the Agency can
consider stategies for a long-term regulatory action.
    As part of the committees' process for developing recommendations
to be considered for regulatory guidance on OSA, the November 2007
Evidence Report was updated in November 2011 and presented at the
December 2011 joint meeting of the MCSAC and the MRB.
    After the December 2011 joint MCSAC-MRB meeting, a MCSAC-MRB
subcommittee was formed in accordance with FACA requirements. The
subcommittee's task was to bring recommendations back to the full joint
committee for deliberation. The subcommittee met publicly on January 4-
5, 2012, to discuss this task and prepared recommendations for the full
MCSAC's and MRB's consideration and deliberation at the February 2012
joint MCSAC-MRB meeting. In February 2012 the joint committee
deliberated and finalized its recommendations on OSA and medical
certification of CMV drivers.

Basis for Proposed Guidance on OSA

    The existing advisory criteria for the Respiratory Dysfunction
requirement [391.41(b)(5)] states that ``There are many conditions that
interfere with oxygen exchange and may result in incapacitation,
including [among others] sleep apnea. If the medical examiner detects a
respiratory dysfunction, that in any way is likely to interfere with
the driver's ability to safely control and drive a commercial motor
vehicle, the driver must be referred to a specialist for further
evaluation and therapy.''
    Currently, FMCSA relies on medical examiners to apply professional
judgment in applying FMCSA's advisory criteria on OSA to determine
whether a driver has a respiratory dysfunction such as OSA that may
affect his or her ability to operate a CMV safely. The motor carrier
community and medical examiners have requested that FMCSA improve the
existing advisory criteria and provide more uniform regulatory guidance
on OSA to the motor carrier industry and medical examiners.

The Proposed Recommendations

Introduction

    The MCSAC and MRB developed and discussed several key questions in
considering Task 11-05 to provide information, concepts, and ideas
FMCSA should consider in developing regulatory guidance for motor
carriers, CMV drivers, and medical examiners on OSA and whether drivers
with this condition should be medically certified to operate CMVs in
interstate commerce. These questions are listed below.
     Are individuals with OSA at an increased risk for a motor
vehicle crash when compared to comparable individuals who do not have
OSA?
     What disease-related factors are associated with an
increased motor vehicle crash risk among individuals with OSA?
     Are individuals with OSA unaware of the presence of the
factors that appear to be associated with an increased motor vehicle
crash risk?
     Are there screening/diagnostic tests available that will
enable examiners to identify those individuals with OSA who are at an
increased risk for a motor vehicle crash?
     Which treatments have been shown to effectively reduce
crash risk among individuals with OSA?
     What is the length of time required following initiation
of an effective treatment for individuals with OSA to reach a degree of
improvement that would permit safe driving?
     How soon following cessation of treatment will individuals
with OSA demonstrate reduced driver safety (i.e., as a consequence of
non-compliance)?
    Discussion of the above questions formed the basis of the joint
MCSAC-MRB recommendations for consideration by FMCSA when developing
regulatory guidance regarding OSA. The joint MCSAC-MRB recommendations
are summarized below.

I. General Recommendations Regarding OSA

    A. OSA diagnosis precludes unconditional certification.
    B. A driver with an OSA diagnosis may be certified if the following
conditions are met:
    1. The driver has untreated OSA with an apnea-hypopnea index (AHI)
of less than or equal to 20 (i.e., mild-to-moderate OSA), and
    2. The driver does not admit to experiencing excess sleepiness
during the major wake period, or
    3. The driver's OSA is being effectively treated.
    C. Notes on AHI threshold:
    1. The AHI threshold is used to prioritize drivers with OSA who
need immediate treatment.
    2. The AHI threshold is set at 20 because crash risk in the
moderate-to-

severe OSA range is statistically higher than for drivers with mild
OSA.
    3. Although an AHI of 15 is likely a safer threshold, there is no
data to support this and such a threshold may be less practical in
terms of enrolling patients for treatment.
    4. Drivers with mild OSA (AHI levels as low as 5) may benefit from
OSA treatment, and should be encouraged to explore treatment options.
    5. Drivers with an AHI between 5 and 20 should be encouraged to
seek treatment if they have a history involving a fatigue-related crash
or a DOT-defined single vehicle crash,\1\ or if they report sleepiness
while operating a motor vehicle.
---------------------------------------------------------------------------

    \1\ Per 49 CFR 390.5, ``accident'' means (1) an occurrence
involving a commercial motor vehicle operating on a highway in
interstate or intrastate commerce which results in: (i) A fatality;
(ii) Bodily injury to a person who, as a result of the injury,
immediately receives medical treatment away from the scene of the
accident; or (iii) One or more motor vehicles incurring disabling
damage as a result of the accident, requiring the motor vehicle(s)
to be transported away from the scene by a tow truck or other motor
vehicle.
---------------------------------------------------------------------------

    D. A driver with an OSA diagnosis may be recertified annually,
based on demonstrating compliance with treatment.
    1. Minimally acceptable compliance with Positive Airway Pressure
(PAP) treatment consists of at least 4 hours per day of use on 70
percent of days.
    2. Drivers should be made aware that more hours of PAP use is
preferable and that optimal treatment efficacy occurs with 7 or more
hours of daily use during sleep.

II. Immediate Disqualification or Certification Denial

    A. Drivers should be disqualified immediately or denied
certification if any of the following conditions are met:
    1. The driver admits to experiencing excessive sleepiness during
the major wake period while driving; or
    2. The driver experienced a crash associated with falling asleep;
or
    3. The driver has been found non-compliant with treatment per
Recommendation I.D.

III. Conditional Certification

    A. Drivers may be granted conditional certification if any of the
following conditions are met:
    1. The driver has an AHI of greater than 20 until compliant with
PAP; or
    2. The driver has undergone surgery and is pending post-op findings
per Recommendations VI-VIII; or
    3. The driver has a Body Mass Index (BMI) of greater than or equal
to 35 kg/m\2\ pending a sleep study.
    B. Notes on BMI threshold:
    1. The MRB is in agreement that a BMI threshold of 33 is supported
by studies.
    2. MCSAC member Robert Petrancosta (Con-Way Freight) asserted that
a BMI threshold should be objectively related to crash risk.
    C. Conditional certification should include the following elements:
    1. A driver with a BMI of greater than or equal to 35 kg/m\2\ may
be certified for 60 days pending sleep study and treatment (if the
driver is diagnosed with OSA).
    2. Within 60 days, if a driver being treated with OSA is compliant
with treatment (per Recommendations I.D. and V-IX), the driver may
receive an additional 90-day conditional certification.
    3. After 90 days, if the driver is still compliant with treatment,
the driver may be certified for no more than 1 year. Future
certification should be dependent on continued compliance.
    D. OSA Screening (i.e., identifying individuals with undiagnosed
OSA)
    1. In addition to a BMI of 35 or above, the following information
may help a clinician diagnose OSA:
    a. Symptoms of OSA may include loud snoring, witnessed apneas, or
sleepiness during the major wake period;
    b. Risk factors of OSA may include the following factors. However,
a single risk factor alone may not infer risk, and a combination of
multiple factors should be examined.
    i. Factors associated with high risk:

--Small or recessed jaw
--Small airway (Mallampati Scale score of Class 3 or 4)
--Neck size (=) 17 inches (male), 15.5 inches (female)
--Hypertension (treated or untreated)
--Type 2 diabetes (treated or untreated)
--Hypothyroidism (untreated)

    ii. Other factors:

--BMI greater than or equal to 28 kg/m\2\
--Age 42 and above
--Family history
--Male or post-menopausal female
--Experienced a single-vehicle crash

IV. Method of Diagnosis and Severity

    A. Methods of diagnosis include in-laboratory polysomnography, at-
home polysomnography, or an FDA-approved limited channel ambulatory
testing device which ensures chain of custody.
    1. In-laboratory polysomnography, which is more comprehensive,
should be considered when the clinician suspects another sleep disorder
in addition to sleep apnea.
    2. New OSA screening technologies will likely emerge.
    B. The driver should be tested while on usual chronic medications.
    C. The MCSAC and MRB did not consider AHI levels from unattended
(i.e., in-home) studies, only in-laboratory sleep studies that detect
the arousal component of hypopneas, as well as saturation.
    1. An in-home sleep study may underestimate AHI when compared to an
in-laboratory sleep study because the in-home study likely does not
consider total sleep time.
    2. The medical examiner should use clinical judgment when
interpreting the results of an unattended sleep study.
    a. If the clinician believes the level of apnea is greater than the
level reported by the in-home study, the clinician should consider
recommending an in-laboratory sleep study.

V. Treatment: Positive Airway Pressure (PAP)

    A. All individuals with OSA should be referred to a clinician with
relevant expertise.
    B. PAP is the preferred OSA therapy.
    C. Adequate PAP pressure should be established through one of the
following methods:
    1. Titration study with polysomnography
    D. Auto-titration system
    A driver who has been disqualified may be conditionally certified
(per Recommendation III) if the following conditions are met:
    1. The driver is successfully treated for one week; and
    2. The driver can demonstrate at least minimal compliance (i.e., 4
hours per use on 70 percent of nights); and
    3. The driver does not report excessive sleepiness during the major
wake period.

VI. Treatment: Bariatric Surgery

    A. After bariatric surgery, a driver may be certified if the
following conditions are met:
    1. Six months have passed since the surgery (for weight loss); and
    2. The driver has been compliant with PAP for six months; and
    3. The driver has been cleared by the treating physician; and
    4. The driver does not report excessive sleepiness during the major
wake period.
    B. After six months have passed since surgery, if the apnea appears
to have resolved, a repeat sleep study should be considered to test for
the presence of ongoing sleep apnea.
    C. Annual recertification:
    1. If clinically indicated, repeat the sleep study.

VII. Treatment: Oropharyngeal Surgery, Facial Bone Surgery

    A. After oropharyngeal or facial bone surgery, a driver may be
certified if the following conditions are met:
    1. One month has passed since surgery; and
    2. The driver has been cleared by the treating physician; and
    3. The driver does not report excessive sleepiness during the major
wake period.
    B. After one month has passed since surgery, if the apnea appears
to have resolved a repeat sleep study should be considered to test for
the presence of ongoing sleep apnea.
    C. Annual recertification:
    1. If clinically indicated, repeat the sleep study.

VIII. Treatment: Tracheostomy

    A. After a tracheostomy, a driver may be certified if the following
conditions are met:
    1. One month has passed since surgery; and
    2. The driver has been cleared by the treating physician; and
    3. The driver does not report excessive sleepiness during the major
wake period.
    B. After one month has passed since surgery, if the apnea appears
to have resolved a repeat sleep study should be considered to test for
the presence of ongoing sleep apnea.
    C. Annual recertification:
    1. If clinically indicated, repeat the sleep study.

IX. Treatment Alternatives

    A. There is limited data regarding compliance and long-term
efficacy of dental appliances and these technologies are not approved
alternatives at this time.\2\
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    \2\ Based on public comments received at the February MCSAC
meeting, one member (Danny Schnautz, Clark Freight Lines, Inc.,
Pasadena, TX) suggested that the efficacy of dental appliances may
need to be reviewed.
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    B. Surgical treatment is acceptable (See Recommendations VI-VIII).

Request for Comments

    FMCSA requests comments on the above joint recommendations provided
to the Agency by its Motor Carrier Safety Advisory Committee and
Medical Review Board on Obstructive Sleep Apnea. Commenters are
requested to provide supporting data wherever appropriate.
    The Agency will consider all comments received before the close of
business May 21, 2012. Comments will be available for examination in
the docket at the location listed under the ADDRESSES section of this
notice. The Agency will file comments received after the comment
closing date in the public docket, and will consider them to the extent
practicable. In addition to late comments, FMCSA will also continue to
file, in the public docket, relevant information that becomes available
after the comment closing date. Interested persons should monitor the
public docket for new material.

    Issued on: April 16, 2012.
 Larry W. Minor,
 Associate Administrator of Policy.
[FR Doc. 2012-9555 Filed 4-19-12; 8:45 am]
BILLING CODE 4910-EX-P