[Federal Register Volume 73, Number 169 (Friday, August 29, 2008)]
[Proposed Rules]
[Pages 50909-50915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-20179]


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DEPARTMENT OF LABOR

Office of the Secretary

29 CFR Part 2

RIN 1290-AA23


Requirements for DOL Agencies' Assessment of Occupational Health 
Risks

AGENCY: Office of the Assistant Secretary for Policy, Office of the 
Secretary, Department of Labor.

ACTION: Notice of proposed rulemaking.

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SUMMARY: Pursuant to the Secretary of Labor's authority at 5 U.S.C. 
section 301, the Department of Labor (Department or DOL) is proposing 
to compile its existing best practices related to risk assessment into 
a single, easy to reference regulation, and to include two requirements 
to establish consistent procedures for conducting risk assessments that 
promote greater public input and awareness of the Department's health 
rulemakings. DOL proposes to issue an Advanced Notice of Proposed 
Rulemaking soliciting public information on relevant data when 
developing risk assessments for health standards regulating 
occupational exposure to toxic substances and hazardous chemicals, and 
to electronically post rulemaking documents and underlying studies used 
in a risk assessment. The proposed regulation implements 
recommendations of the 1997 Presidential/Congressional Commission on 
Risk Assessment and Risk Management Report,\1\ and is consistent with 
Government-wide Office of Management and Budget's (OMB) Information 
Quality Guidelines,\2\ current internal DOL Information Quality 
Guidelines,\3\ and the OMB/ Office of Science and Technology Policy 
2007 Memorandum on Updated Principles for Risk Analysis.\4\
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    \1\ Presidential/Congressional Commission on Risk Assessment and 
Risk Management, Framework for Environmental Health Risk Management, 
2 Final Report 131-36 (1997).
    \2\ http://www.whitehouse.gov/omb/fedreg/2005/011405_peer.pdf.
    \3\ U.S. Dept. of Labor, Guidelines for Ensuring and Maximizing 
the Quality, Objectivity, Utility, and Integrity of Information 
Disseminated by the Department of Labor (2002) (Appendix II), 
available at http://www.dol.gov/informationquality.htm.
    \4\ OMB/OSTP Memorandum for the Heads of Executive Departments 
and Agencies, Updated Principles for Risk Analysis (2007) M-07-24, 
available at http://www.whitehouse.gov/omb/memoranda/fy2007/m07-24.pdf.

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DATES: Comments must be submitted on or before September 29, 2008.

ADDRESSES: You may submit comments, identified by RIN, by one of the 
following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail/Hand Delivery/Courier: Submit comments to Office of 
the Assistant Secretary for Policy, 200 Constitution Avenue, NW., S-
2312, Washington, DC 20210, Attention: Risk Assessment Policy. Because 
of security-related concerns, there may be a significant delay in the 
receipt of submissions by United States Mail. You must take this into 
consideration when preparing to meet the deadline for submitting 
comments.
    Instructions: All submissions received must include the agency name 
and Regulatory Information Number (RIN) for this rulemaking. Comments 
received will be posted without change to http://www.regulations.gov, 
and available for public inspection in the Office of the Assistant 
Secretary for Policy, 200 Constitution Avenue, NW., S-2312, Washington, 
DC 20210, including any personal information provided. Persons 
submitting comments electronically are encouraged not to submit paper 
copies.
    Docket: All comments will be available for public inspection and 
copying during normal business hours by contacting OASP at (202) 693-
5959 (VOICE) (this is not a toll free number) or 1-877-889-5627 (TTY/
TDD). You may also contact OASP at the address listed above. As noted 
above, the Department also will post all comments it receives on http://www.regulations.gov.
    Copies of the proposed rule are available in alternative formats of 
large print and electronic file on computer disk, which may be obtained 
at the above-stated address.

FOR FURTHER INFORMATION CONTACT: Kathleen Franks, Office of Regulatory 
and Programmatic Policy, Office of the Assistant Secretary for Policy, 
U.S. Department of Labor, (202) 693-5959. This is not a toll-free 
number. Individuals with hearing or speech impairments may access the 
telephone number above via TTY by calling the toll-free Federal 
Information Relay Service at 1-800-877-8339.

SUPPLEMENTARY INFORMATION:

 A. Background

The Department's Mission Under the Occupational Safety and Health Act 
and Federal Mine Safety and Health Act

    The Secretary of Labor (Secretary) is charged with ensuring safe 
and healthful working conditions for every working man and woman in the 
Nation. To that end, the Secretary has broad authority to promulgate 
health standards. In Section 6(b)(5) of the Occupational Safety and 
Health Act of 1970 (OSH Act) \5\ and Section 101(a)(6) (A) of the 
Federal Mine Safety and Health Act of 1977 (Mine Act),\6\ Congress 
required the Secretary to set health standards ``on the basis of the 
best available evidence.'' \7\ The Acts also state that, ``in addition 
to the attainment of the highest degree of health and safety protection 
for the employee, other considerations shall be the latest available 
scientific data in the field.'' \8\ In sum, the OSH Act and Mine Act

[[Page 50910]]

reflect a basic principle that agency actions should be based on the 
best scientific information available at the time of the agency action. 
The Government-wide Office of Management and Budget (OMB) Information 
Quality Guidelines,\9\ existing internal U.S. Department of Labor 
(Department or DOL) Information Quality Guidelines,\10\ and the OMB/ 
Office of Science and Technology Policy (OSTP) 2007 Memorandum on 
Updated Principles for Risk Analysis further reflect this 
principle.\11\
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    \5\ 29 U.S.C. 655 (2000).
    \6\ 30 U.S.C. 811 (2000).
    \7\ 29 U.S.C. 655(b)(5) (2000), 30 U.S.C. 811(a)(6) (2000).
    \8\ Id.
    \9\ http://www.whitehouse.gov/omb/fedreg/2005/011405_peer.pdf.
    \10\ http://www.dol.gov/informationquality.htm.
    \11\ OMB/OSTP Memorandum for the Heads of Executive Departments 
and Agencies, Updated Principles for Risk Analysis (2007) M-07-24, 
available at http://www.whitehouse.gov/omb/memoranda/fy2007/m07-24.pdf.
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    This proposed regulation compiles in one easy-to reference 
regulation, all of the Department's existing best practices related to 
risk assessment, and includes two requirements to establish consistent 
procedures that promote greater public input and awareness of the 
Department's health rulemakings. The Department is proposing this 
rulemaking pursuant to the Secretary's authority at 5 U.S.C. section 
301 to prescribe regulations related to the performance of the agency's 
business and the conduct of its employees. Because the Department is 
not required to seek public comment on its internal procedures under 
the Administrative Procedure Act (APA),\12\ the Regulatory Flexibility 
Act does not apply to this rulemaking.\13\ Although the Department is 
not required to seek public comment on this proposal, it has chosen to 
do so in order to gain valuable public input and in the interests of 
full transparency and accountability. In addition, because this 
rulemaking merely communicates to the public how the Department will 
regulate itself, and does not require the regulated community to 
provide conditions or adopt practices to provide safe or healthful 
employment, it does not constitute an ``occupational safety and health 
standard'' for the purposes of the public hearing requirements of the 
OSH Act \14\ and Mine Act.\15\
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    \12\ 5 U.S.C. 553(b)(A).
    \13\ See, 5 U.S.C. 601 (2000).
    \14\ See, 29 U.S.C. 652(8) (2000) and Sec.  655(b)(3) (2000).
    \15\ See, 30 U.S.C. 811(a)(3) (2000).
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Public Accountability and the Need for Consistency, Reliability and 
Transparency in the Department's Risk Assessment Procedures

    Federal risk assessment and management policies were thoroughly 
studied by the Presidential/Congressional Commission on Risk Assessment 
and Risk Management (Commission on Risk), which was created by the 1990 
Clean Air Act Amendments, ``to make a full investigation of the policy 
implications and appropriate uses of risk assessment and risk 
management in regulatory programs under various Federal laws to prevent 
cancer and other chronic human health effects which may result from 
exposure to hazardous substances.'' \16\ In its 1997 final report, the 
Commission on Risk made specific findings with respect to the 
Occupational Safety and Health Administration (OSHA). In particular, it 
found that, ``OSHA seems to have relied upon a case-by-case approach 
for performing risk assessment and risk characterization,'' and 
recommended that the agency publish guidelines laying out its 
scientific and policy defaults with regard to risk assessment and risk 
characterization in support of risk management.\17\ This NPRM 
implements the Commission on Risk's recommendation by explaining the 
agency's existing best practices related to risk assessment in one 
easy-to reference regulation, and including two requirements to 
establish consistent procedures that promote greater public input into 
and awareness of the Department's health rulemakings. This proposed 
regulation is a compilation of basic principles and practices related 
to risk assessment. As such, it ensures that DOL's scientists have the 
necessary latitude to exercise their professional discretion and to 
modify their assessments as science evolves, while assuring that the 
Department's process is fully accountable to the public.
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    \16\ 42 U.S.C. 7412 note, Pub. L. 101-549, Sec.  303, Nov. 15, 
1990.
    \17\ Presidential/Congressional Commission on Risk Assessment 
and Risk Management, Framework for Environmental Health Risk 
Management, 2 Final Report 131-36 (1997) (Commission on Risk 
Report).
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    This proposal is drawn from the agency's historical experience 
promulgating rules under the OSH Act \18\ and the Mine Act,\19\ and 
technical expertise on the American workforce and occupational health 
standards in general. It is also consistent with OMB/ OSTP's September 
19, 2007, Memorandum to the Heads of Executive Departments and Agencies 
on Updated Principles for Risk Analysis,\20\ the OMB Government-wide 
Information Quality Guidelines,\21\ and existing internal DOL 
Information Quality Guidelines.\22\
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    \18\ 29 U.S.C. 655 (2000).
    \19\ 30 U.S.C. 811 (2000).
    \20\ OMB/OSTP Memorandum for the Heads of Executive Departments 
and Agencies, Updated Principles for Risk Analysis (2007) M-07-24, 
available at http://www.whitehouse.gov/omb/memoranda/fy2007/m07-24.pdf.
    \21\ http://www.whitehouse.gov/omb/fedreg/2005/011405_peer.pdf.
    \22\ http://www.dol.gov/informationquality.htm.
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    The core principles underlying this rulemaking are:
     Transparency: The reasoning, assumptions, calculations, 
methods and data on which risk assessment findings and risk management 
decisions are made should be presented in an open and readily 
accessible format to enable members of the public to review, critique, 
and replicate the process leading to the Department's findings and 
decisions. Where results embody uncertainty, the degree of uncertainty 
should be clearly stated and quantified in probabilistic terms if 
adequate data are available, and the analysis adds value to the risk 
management decision process.
     Consistency: The approaches used to assess risk should 
conform to accepted scientific practice and strive to be consistent 
with approaches used in previous occupational standards that address 
similar hazards and agents. A justification should be provided when 
alternate approaches are employed. The choice of methods, procedures 
and approaches should be based on objective criteria and adhere to 
basic principles that have achieved general scientific acceptance. 
While consistency is a key objective, risk analysis is an evolving 
scientific process and agencies must retain sufficient flexibility to 
incorporate methodological and analytical advances. In addition, to the 
extent risk analyses must be tailored for particular projects, the 
Department's agencies should clearly articulate the reasons for 
selecting the methodologies used.
     Reliability: Analyses and calculations must be based on 
the best available scientific data and practices consistent with the 
Federal Government's directives on information quality and peer review.
    The underlying principles of this proposed rulemaking are not new, 
but rather reflect existing agency best practices and broad scientific 
consensus. This proposed rulemaking will reinforce those existing best 
practices and by compiling DOL's procedures into a single, easy to 
reference, policy statement reflects the agency's historical commitment 
to public accountability.

[[Page 50911]]

Compilation of the Department's Existing Best Practices Related to Risk 
Assessment

    Currently, the Department does not have comprehensive regulations 
or internal guidance laying out its scientific and policy defaults with 
regard to risk assessment and characterization. The Department has, 
however, developed best practices related to risk assessment. It also 
follows internal DOL guidelines governing the information quality 
aspects of risk assessments, and conducts peer review of important 
scientific information in accordance with OMB's Government-wide 
Information Quality Bulletin for Peer Review.\23\
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    \23\ http://www.whitehouse.gov/omb/fedreg/2005/011405_peer.pdf.
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B. The Department's Risk Assessment Paradigm

    Within the Department, risk assessments related to the regulation 
of occupational exposure to toxic substances and hazardous chemicals 
are performed primarily by OSHA and the Mine Safety and Health 
Administration (MSHA). This section provides a summary of the 
Department's risk assessment paradigm and existing best practices. For 
the purposes of this rulemaking, ``risk assessment'' is defined as the 
overall process of evaluating the risk associated with a health hazard 
from a toxic substance or hazardous chemical. A ``hazard'' is an 
intrinsic property of a substance or event, which has the potential to 
cause harm. ``Risk'' is the probability of the occurrence of harm given 
exposure to the hazard.
    DOL's risk assessment paradigm incorporates the following steps:
    a. Hazard identification. The hazard identification step examines 
whether a substance or chemical is a health hazard;
    b. Dose-response assessment. The dose response assessment step 
examines the relationship between exposure to a hazardous substance and 
an adverse health outcome.
    c. Exposure assessment. The exposure assessment step estimates 
exposure to the hazardous substance in the workplace.
    d. Risk characterization. The risk characterization step provides 
estimates of risk to workers from occupational exposure scenarios of 
interest. The risk characterization also summarizes the key findings 
and discusses the limitations of the data, the choice of assumptions, 
the inherent uncertainties associated with the estimates of risk, 
limitations of the database, and how these factors impact the risk 
assessment.
    Under the Department's existing current Information Quality 
Guidelines,\24\ OSHA and MSHA are required to use the best available 
scientific methodologies, information and health and exposure data when 
conducting the analyses for each of the four steps in the risk 
assessment paradigm. In addition, to assure that a consistent and 
scientifically defensible approach is used throughout the process, DOL 
agencies describe key assumptions that are made in the risk assessment 
and discuss their impacts on the outcome and proper interpretation of 
the risk assessment in both the presentation of dose-response models to 
DOL risk managers and all public risk assessment documents.
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    \24\ http://www.dol.gov/informationquality.htm.
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1. Hazard Identification

    The foundation for every risk assessment is a thorough compilation 
of relevant studies and information. Currently, the Department's 
agencies start the process of risk assessment by reviewing applicable 
scientific information to determine whether a toxic substance or 
hazardous chemical is a health hazard. Risk assessors gather applicable 
information directly from the National Institute for Occupational 
Safety and Health (NIOSH), the Environmental Protection Agency (EPA), 
other Federal agencies, academic researchers, stakeholders, 
petitioners, and other experts. Also, relevant studies may be provided 
to the DOL's agencies as part of a petition for rulemaking. 
Supplementary searches may be performed using scientific literature 
databases to obtain a complete profile of the chemical of interest.
    An important component of hazard identification is the selection of 
health endpoints, which are the outcomes that result from exposure to a 
hazard. Endpoints can be selected for chemicals based on observational 
studies (epidemiologic studies), industrial hygiene assessments, 
medical assessments, experimental studies (toxicological studies), 
surveillance data, and toxicological screening batteries. The hazard 
identification discussion includes an explanation of the basis for 
selecting the particular health endpoints and an analysis of the 
overall reliability of studies relied upon. Given that there are many 
different designs for studies, simple rules for their evaluation do not 
exist. However, key factors that affect the reliability of the 
epidemiological studies include: the power of the study to detect the 
endpoint, biases that may make the study data not representative of the 
whole population, and confounders (e.g., age, smoking, or drug use). 
For animal studies, key considerations include quality of the study 
design, number of dose groups, number of animals per dose group, range 
of dose levels employed, route of exposure, and human relevance of 
health outcomes found in the studies.
    The hazard identification phase of a risk assessment is currently 
published by DOL in the ``Health Effects'' chapter of the preamble to 
proposed and final rules. The discussion includes a summary of the 
database and an opinion as to the confidence with which conclusions can 
be drawn from this database, any alternative conclusions that are 
supported by the database, and any significant data gaps.

2. Dose-Response Assessment

    A dose-response assessment examines the relationship between 
exposure to the toxin or chemical agent in question and the health 
effects of concern. Under the Department's current procedures, the 
quantitative estimation of health risk may involve the use of dose-
response mathematical models which extrapolate scientifically 
observable data in humans or animals to a variety of exposure 
scenarios. The dose-response assessment ultimately strives to 
quantitatively estimate health risk in the range of occupational 
exposures of interest, e.g. the current exposure limit or exposure 
levels being considered for new or revised limits. The process 
generally involves: Selection of suitable study data, exposure metrics, 
and health endpoints; selection and application of appropriate risk 
models to the data; characterization of the uncertainties and 
limitations in the assessment; and a discussion of how the results 
compare to other published dose-response assessments for the same agent 
under similar exposure conditions.
    While many studies may add to the overall weight of evidence, the 
Department often finds that only select data are suitable for making 
quantitative estimates of risk. Dose-response assessments must be 
conducted with complete scientific objectivity and transparency. The 
criteria and rationale for the selection of studies and health 
endpoints used in the analysis should be fully explained. The 
assessment should explore a range of plausible risk models and exposure 
metrics consistent with scientific understanding about the agent and 
its mode of action. If physiologically based models are applied to the 
data, the chosen input parameters should be well supported

[[Page 50912]]

and the model sufficiently documented and validated. The quantitative 
dose response assessment should give preference to those risk models 
that have previously undergone scientific peer review, if such models 
are appropriate and compatible with the available data. Risk 
descriptors should be presented as estimates of central tendency along 
with the appropriate upper and lower bounds. The assessment should 
strive to determine whether the quantitative estimates are consistent 
with other risk assessments and with positive and negative animal or 
epidemiological studies of the hazard in question. Any assumptions and 
other judgments used in the absence of data are stated and the 
rationale articulated.
    The risk assessment should characterize strengths, limitations and 
uncertainties in the data sets and models employed in the dose-response 
assessment, as well as important sources of variability in risk from 
occupational exposures. The assessment should discuss the impact of key 
assumptions, uncertainties, and factors that interact with the agent of 
concern. Quantitative uncertainty and sensitivity analyses should be 
considered if adequate information is available and its use would add 
value to the risk management decision. Population variability in risk 
should be characterized when appropriate, given adequate information 
and analytical approaches. The assessment should address vulnerable 
and/or susceptible workers populations where there is scientific 
evidence to support potential differences in risk. The dose-response 
assessment is currently published by the Department in the ``Risk 
Assessment'' chapter of the preamble to proposed and final rules.

3. Exposure Assessment

    In the exposure assessment phase of risk assessment, the Department 
identifies all industry sectors where employees may be potentially 
exposed to the substance of interest, and estimates current exposures 
by industry and job title. Exposure parameters include the level, 
duration, route, and frequency of exposure. In past rulemakings, OSHA 
and MSHA have found relatively few peer-reviewed studies from which 
they could reliably construct exposure profiles for all or most 
affected industry sectors. Instead, the agencies have typically relied 
on exposure data generated by enforcement activity, data obtained by 
the agencies or their contractors during site visits, exposure data 
submitted to the record by industry or labor organizations, and 
industry studies conducted by NIOSH. To develop a profile of the 
population at risk, the Department usually relies on statistics 
published by the Bureau of Labor Statistics (BLS) or the U.S. Bureau of 
the Census.
    There should be included adequate characterization of relevant 
information in determining exposure to an agent. Where there are known 
differences in exposure for different individuals or subpopulations, 
the Department's agencies characterize this variability. Risk managers 
are better informed when an understanding of variability and the key 
contributors to the cause of this variability are presented in the 
exposure analysis.\25\ The exposure assessment analysis is currently 
provided by the Department in the ``Industry Profile'' chapter of the 
Economic Analysis that accompanies proposed and final rules.
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    \25\ U.S. Office of Management and Budget (OMB) and Office of 
Science and Technology Policy (OSTP), Memorandum for the Heads of 
Executive Departments and Agencies, Updated Principles for Risk 
Analysis (2007) M-07-24, available at http://www.whitehouse.gov/omb/memoranda/fy2007/m07-24.pdf.
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4. Risk Characterization

    Finally, the risk characterization phase of a risk assessment 
summarizes the findings of the hazard identification, dose-response 
assessment, and the exposure assessment steps, and ultimately serves as 
a bridge between the risk assessment and risk management processes. 
Risk characterization conveys to agency risk managers, stakeholders, 
and the public, the key findings that risk assessors have derived about 
the nature and magnitude of the health risks from occupational exposure 
to a particular toxin or hazardous chemical. It also includes a 
discussion of the empirical strengths and weaknesses of the risk 
assessment. With this knowledge, a risk manager is prepared to make 
policy decisions about how to best manage the particular risk.
    The Department's risk characterizations indicate the range of risks 
posed to workers. Specifically, the occupational exposure profiles and 
the quantitative estimates of risk are used to estimate the adverse 
health impacts, e.g., number of lung cancers, associated with current 
exposure conditions, and to analyze the benefits in terms of health 
risk avoided, e.g., lung cancers prevented, that are expected to arise 
from compliance with the proposed occupational standard. In the case of 
OSHA, the risk characterization also shows how those risks pertain to 
the legal requirement that the agency determine whether a significant 
risk exists that can be eliminated or lessened by a change in 
practices, and the reduction of risk that is necessary to eliminate 
significant risk.
    OSHA and MSHA historically report their ``best estimate'' of the 
risk to workers exposed to a health hazard. This is typically an 
estimate that the agencies refer to as a ``maximum likelihood'' 
estimate (MLE) derived from using the statistical method of maximum 
likelihood estimation to fit a mathematical exposure-response curve to 
dose-response data. The agencies also typically report statistical 
upper and lower limits of their estimates of the MLE of risk.\26\ Risk 
characterizations identify inherent uncertainties associated with 
estimates of risk. When a quantitative characterization of risk is 
provided, a range of plausible risk estimates is provided. Quantitative 
uncertainty analysis, sensitivity analysis, and a discussion of model 
uncertainty are utilized when possible. In addition, the Department is 
usually faced with a range of choices on assumptions and inputs used in 
dose-response models because risk assessments are typically conducted 
with limited amounts of data. Thus, some assumptions must be made to 
predict the effects of exposure to toxins or hazardous chemicals. The 
Supreme Court has confirmed that OSHA, ``is free to use conservative 
assumptions in interpreting the data with respect to carcinogens, 
risking error on the side of overprotection rather than 
underprotection.'' \27\ The decision to adopt a particular assumption 
over another must always be rational, transparent and fully articulated 
to both risk managers and the public. The risk characterization is 
currently published by the Department in the ``Significance of Risk'' 
section of the preamble and the ``Benefits'' chapter of the Economic 
Analysis that accompanies proposed and final rules.
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    \26\ See for example, Hexavalent Chromium rule 39 FR 10195 
(February 28, 2006).
    \27\ Industrial Union Dept. v. American Petroleum Inst., 448 
U.S. 607, 656, 100 S.Ct. 2844, 2871 (1980).
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    Once a risk assessment is complete, the agencies then turn to 
reduction of the identified risk through risk management. For the 
purposes of this rulemaking, ``risk management'' is defined as policy 
decision-making that applies the findings of risk assessment within 
statutory and other legal parameters to reduce, control or mitigate 
health hazards. The Supreme Court has interpreted the OSH Act to 
require that the Department find there is a ``significant risk'' that 
can be eliminated or lessened by a change in practices before 
promulgating any health

[[Page 50913]]

standard.\28\ ``Significant risk'' was not, however, defined by the 
Court. Instead the Court deemed it to be the agency's, ``responsibility 
to determine, in the first instance, what it considers to be a 
`significant' risk.'' \29\ In a later case, the Supreme Court held that 
a cost-benefit analysis by OSHA is not required by the statute because 
a feasibility analysis is instead.\30\ The Court explained that, 
``Congress itself defined the basic relationship between costs and 
benefits, by placing the `benefit' of worker health above all other 
considerations save those making attainment of this `benefit' 
unachievable.'' \31\
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    \28\ Id. at 614-15.
    \29\ Id. at 655.
    \30\ See, American Textile Mfrs. Inst., Inc. v. Donovan, 452 
U.S. 490, 509, 101 S.Ct. 2478, 2490-91 (1981).
    \31\ Id.
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    Risk management integrates risk characterization results with 
Department policies and directives, and other information to assess 
policy options and recommend regulatory action. This may include 
consideration of both positive and negative studies, in light of each 
study's technical quality. The scientific community continues to 
develop techniques for weight of evidence evaluations, and DOL risk 
assessors and managers should make every effort to keep apprised of 
developments and recommended best practices.

C. Best Available Evidence: DOL's Internal Guidance on Information 
Quality

    As mentioned previously, the Department currently has internal 
guidance on information quality that seeks to assure that the best 
available evidence and most up to date scientific information is used 
in setting health standards to protect American workers. In the 1996 
Amendments to the Safe Drinking Water Act (SDWA Amendments), Congress 
emphasized that risk analyses under the SDWA should be based upon the 
best available scientific methodologies, information, data, and weight 
of the available scientific evidence.\32\ The Department later adopted 
those principles for its health and safety risk analyses in accordance 
with the requirements of OMB's Government-wide Information Quality 
Guidelines.
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    \32\ 42 U.S.C. 300g-1(b)(3)(A) and (B) (2000).
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    The Department's internal Information Quality Guidelines mandate 
that:
    1. In taking agency actions that are based on the use of science in 
the analysis of health risks, the agency shall use:
    a. The best available peer-reviewed science and supporting studies 
conducted in accordance with sound and objective scientific practices; 
and
    b. Data collected by accepted methods or best available methods (if 
the reliability of the method and the nature of the decision justify 
use of the data), including:
    i. Exposure data such as that generated by enforcement activity, 
contained in published literature, and submitted to the rulemaking 
record; and
    ii. Testimony and comment from experts familiar with the underlying 
scientific information related to the risk analysis and other relevant 
information in the rulemaking record.
    2. In the dissemination of public information about risks, the 
agency shall ensure that the presentation of information about risk 
effects is comprehensive, informative, and understandable, within the 
context of its intended purpose.
    3. In a quantitative analysis of health risks made available to the 
public, the agency shall specify, to the extent practicable:
    a. Each population addressed by any estimate of public health 
effects;
    b. The expected risk or central estimate of risk for the specific 
populations;
    c. Each appropriate upper-bound or lower-bound estimate of risk;
    d. Each significant uncertainty identified in the assessment of 
public health effects and studies that would assist in resolving the 
uncertainty; and
    e. Information, data, or studies, peer-reviewed where available, 
known to the agency that support, are directly relevant to, or fail to 
support any estimate of risk effects and a discussion that reconciles 
inconsistencies in the data or information, and explains the rationale 
used by the agency to rely on the data or information used for the risk 
analysis.
    During the course of rulemaking, OSHA and MSHA consider and address 
data, expert testimony, and public comments pointing out uncertainties 
in the risk assessment and conflicting scientific evidence. The 
agencies present their reasons for accepting certain studies or data, 
rejecting others, and reconcile apparent discrepancies or conflicts in 
the available data to the extent possible. The Department strives to 
obtain the best available evidence in all key assumptions and defaults 
underlying its risk assessments, but the use of assumptions is 
invariably necessary if information is lacking. For example, the 
Department identifies all industry sectors where employees may be 
potentially exposed to the substance of interest and uses the best 
available data, combined with reasonable assumptions to fill data gaps, 
to characterize current exposures by industry and job title, and the 
frequency, intensity and duration of exposure to workers.\33\
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    \33\ DOL has previously solicited information regarding the 
duration of employment in various occupational groups when proposing 
to regulate occupational exposure to tuberculosis. See 62 FR 54,160, 
54,193 (October 17, 1997). (Later withdrawn for unrelated reasons. 
68 FR 75767 (December 31, 2003)). In the Hexavalent Chromium 
rulemaking, a 20 year working life was selected as another 
reasonable assumption to illustrate the effect of exposure duration 
on risk, 71 FR 10,100, 10,224 (February 28, 2006), and the Asbestos 
rule presented risk estimates for 1, 20 and 45 year durations. 51 FR 
22,612, 22,644 (June 20, 1986).
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    The Department's internal Information Quality Guidelines are 
consistent with the principles of the OMB/OSTP 2007 Memorandum on 
Updated Principles for Risk Analysis. The agency also complies with 
OMB's Government-wide Information Quality Bulletin for Peer Review, 
which requires the peer review of important scientific information 
before dissemination or use by qualified, independent specialists or 
scientists who were not involved in producing the product under review. 
The Department posts on its Web site a public agenda of peer review 
plans for all planned and ongoing influential scientific 
information,\34\ and submits an annual report to OMB summarizing the 
peer reviews conducted by the agency during the previous fiscal year.
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    \34\ http://www.dol.gov/asp/peer-review/index.htm.
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D. The Department's Proposals for Comment

    The Department requests public comment on the following proposals:
ANPRM: Casting a Wide Net for the Best Available Data
    The Department believes that any health rulemaking should involve 
the open and vigorous exchange of information and ideas among technical 
experts in the relevant disciplines, policy makers, and the public. In 
light of the OSH Act's and Mine Act's mandates that the Secretary set 
health standards based on the best scientific information available at 
the time of the agency action, it is particularly important that the 
Department seek out and receive all relevant data before proposing a 
health standard. Therefore, the Department is proposing that when 
developing a health standard regulating occupational exposure to a 
toxic substance or hazardous chemical, its agencies shall issue an 
Advance Notice of Proposed Rulemaking (ANPRM) soliciting public input 
on studies,

[[Page 50914]]

scientific information, data describing the frequency, intensity and 
duration of exposure of workers in the affected industries and 
occupations, key default factors and assumptions, and other relevant 
information, prior to issuing a Notice of Proposed Rulemaking (NPRM) or 
other regulatory action in that health rulemaking. The Department's 
agencies shall publish an ANPRM except when issuing emergency temporary 
standards under section 6(c) of the OSH Act, 29 U.S.C. 655(c) or 
section 101(b)(1) of the Mine Act, 30 U.S.C. 811(b)(1).
    Any public comments received in response to the ANPRM shall be 
reviewed by the agencies, and the strength or weakness of any data 
received shall be carefully evaluated by agency scientists and experts 
in the same manner that comments in response to an NPRM are reviewed. 
The Department expects that the publication of the ANPRM, collection of 
public comments, and review will occur simultaneously with the ordinary 
development of the standard in order to ensure that the rulemaking 
process is not delayed or slowed. For instance, publication of the 
ANPRM could occur soon after the proposed standard is placed on the 
regulatory agenda which is the period of time when the agency would 
typically be gathering information related to the proposed rulemaking, 
or concurrently with the Small Business Regulatory Enforcement Fairness 
Act (SBREFA) \35\ process. Finally, it should be noted that using an 
ANPRM to gather public information at the beginning of the development 
of a health standard is not a new procedure for the Department. DOL has 
issued an ANPRM in at least half of the health standards regulating 
exposure to toxins that have been promulgated over the last two 
Administrations, including the last three standards issued, Hexavalent 
Chromium in 2006,\36\ Methylene Chloride in 1997,\37\ and Butadiene in 
1996.\38\ The Department believes the risk assessment and rulemaking 
process will be strengthened by consistent opportunities for public 
input through an ANPRM.
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    \35\ 5 U.S.C. 609(b).
    \36\ 71 FR 10,100 (February 28, 2006).
    \37\ 62 FR 1,493 (January 10, 1997).
    \38\ 61 FR 56,746 (November 4, 1996).
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Electronic Posting of Rulemaking Information
    Transparency and easy public access to all rulemaking information 
is a key principle of this rulemaking and also consistent with the 
existing DOL and OMB guidelines. Accordingly, the Department proposes 
to electronically post together in an easily accessible and well-
organized format on http://www.regulations.gov and/or http://www.dol.gov, all relevant documents related to a rulemaking addressing 
occupational exposure to toxic substances and hazardous chemicals no 
later than fourteen days after the conclusion of the relevant 
rulemaking step that relied upon or utilized those documents. Those 
rulemaking steps would include but are not limited to: publication of 
the ANPRM, conclusion of the SBREFA process, publication of the NPRM, 
conclusion of any public hearing under the OSH Act and Mine Act, and 
the publication of the Final Rule. The documents to be posted would 
include but are not limited to: any underlying scientific studies 
relied upon in the rulemaking, to the extent possible given copyright 
limitations; all risk assessment analyses underlying the NPRM and Final 
Rule; the text of the ANPRM; SBREFA process documents; the text of the 
NPRM; all public hearing transcripts and briefs; all public comments; 
the final docket of the rulemaking; and the text of the Final Rule. 
This transparency requirement will move the Department closer to the 
EPA approach of providing all applicable documents in the rulemaking 
docket, and enhance public access to agency information.
Conclusion
    The Department invites comment from the public on two proposed 
procedural requirements: (1) To issue an ANPRM seeking public input on 
key data and assumptions when developing a health standard; and (2) to 
electronically post all relevant documents after each regulatory step 
in a health rulemaking.
    We encourage the submission of comments and other relevant 
information to the Federal eRulemaking Portal at http://www.regulations.gov or to the Office of the Assistant Secretary for 
Policy in accordance with the instructions provided above.
Executive Order 12866
    This rule has been drafted and reviewed in accordance with 
Executive Order 12866, section 1(b), Principles of Regulations. The 
agency has determined that this rule is not a ``significant regulatory 
action'' under Executive Order 12866, section 3(f), Regulatory Planning 
and Review. Accordingly, there is no requirement for an assessment of 
potential costs and benefits under section 6(a)(3) of that order.
Regulatory Flexibility Act
    Because no notice of proposed rulemaking is required for this rule 
under section 553(b) of the Administrative Procedure Act (APA), the 
requirements of the Regulatory Flexibility Act (5 U.S.C. 601) 
pertaining to regulatory flexibility do not apply to this rule. See 5 
U.S.C. 601(2).
Paperwork Reduction Act
    This rule is not subject to section 350(h) of the Paperwork 
Reduction Act (44 U.S.C. 3501) since it does not contain any new 
collection of information requirements.
Small Business Regulatory Enforcement Fairness Act of 1996
    This rule is not classified as a ``rule'' under Chapter 8 of the 
Small Business Regulatory Enforcement Fairness Act of 1996, because it 
is a rule pertaining to agency organization, procedure, or practice 
that does not substantially affect the rights or obligations of non-
agency parties. See 5 U.S.C. 804(3)(C).

List of Subjects in 29 CFR Part 2

    Administrative practice and procedure, Claims, Courts, Government 
employees.

    For the reasons outlined in the preamble, the Department of Labor 
proposes to amend 29 CFR part 2 as follows:

PART 2--GENERAL REGULATIONS

    1. The authority citation for part 2 continues to read as follows:

    Authority: 5 U.S.C. 301; Executive Order 13198, 66 FR 8497, 3 
CFR 2001 Comp., p. 750; Executive Order 13279, 67 FR 77141, 3 CFR 
2002 Comp., p. 258.

    2. Add Sec.  2.9 to subpart A to read as follows:


Sec.  2.9  Assessment of Occupational Health Risks.

    (a) Purpose. These provisions apply to risk assessments prepared by 
DOL agencies and to risk assessments prepared by others, for use by 
DOL, in relation to the development of health standards. Risk 
assessments for the development of health standards addressing toxic 
substances and hazardous chemicals shall be prepared in the following 
manner.
    (b) Definition. Significant risk. The Department shall find, as a 
threshold matter, that there is a significant risk that can be 
eliminated or lessened by a change in practices before promulgating a 
health standard pursuant to the Occupational Safety and Health Act.
    (c) Risk assessments overview.

[[Page 50915]]

    (1) Department agencies shall issue an Advance Notice of Proposed 
Rulemaking (ANPRM) soliciting public input on relevant studies and 
scientific information, data regarding the frequency, intensity, 
duration and other parameters of worker exposure in the affected 
industries, occupations and activities, key default factors and 
assumptions, and other relevant information related to the development 
of a health standard regulating occupational exposure to a particular 
toxic substance or hazardous chemical prior to issuing a Notice of 
Proposed Rulemaking (NPRM) or other regulatory action in that health 
rulemaking, except when promulgating an emergency temporary standard 
under section 6(c) of the OSH Act, 29 U.S.C. 655(c) (2000) or section 
101(b)(1) of the Mine Act, 30 U.S.C. 811(b)(1) (2000).
    (2) In its risk assessments, the Department's agencies shall 
identify and discuss key issues including, but not limited to, the 
reliability of data, significant uncertainties, choice of assumptions 
and default factors, and shall address all related comments from the 
public and peer reviewers in the subsequent Notice of Proposed 
Rulemaking (NPRM) and Final Rule.
    (3) Risk assessments shall utilize the best available evidence, and 
the latest available scientific data in the field, including industry-
by-industry evidence relating to working life exposures.
    (4) Department risk assessments shall include and identify the 
following four components:
    (i) Hazard identification. The hazard identification step examines 
whether a substance or chemical is a health hazard;
    (ii) Dose-response assessment. The dose response assessment step 
examines the relationship between exposure to a hazardous substance and 
an adverse health outcome;
    (iii) Exposure assessment. The exposure assessment step estimates 
exposure to the hazardous substance in the workplace;
    (iv) Risk characterization. The risk characterization step provides 
estimates of risk to workers from occupational exposure scenarios of 
interest. The risk characterization also summarizes the key findings 
and discusses the limitations of the data, the choice of assumptions, 
the inherent uncertainties associated with the estimates of risk, 
limitations of the database, and how these factors impact the risk 
assessment.
    (5) Information quality and peer review. Risk assessments shall be 
performed in accordance with Office of Management and Budget's (OMB) 
and the Department's information quality and peer review guidelines.
    (d) Public access to rulemaking information.
    (1) The Department shall post together in an easily accessible and 
well organized format on http://www.regulations.gov, all relevant 
documents related to any rulemaking addressing occupational exposure to 
toxic substances and hazardous chemicals no later than fourteen days 
after the conclusion of the relevant step in the rulemaking process, 
including but not limited to publication of the ANPRM, conclusion of 
the Small Business Regulatory Fairness Act (SBREFA) process, 
publication of the NPRM, conclusion of any public hearing and the 
publication of the Final Rule.
    (2) The documents posted shall include but are not limited to any 
underlying scientific studies relied upon in the rulemaking, to the 
extent possible given copyright limitations; all risk assessment 
analyses underlying the NPRM and Final Rule; the text of the ANPRM; 
SBREFA process documents; the text of the NPRM; all public hearing 
transcripts and briefs; all public comments; the final docket of the 
rulemaking; and the text of the Final Rule.

    Signed at Washington, DC, this 26th day of August 2008.
Leon R. Sequeira,
Assistant Secretary for Policy.
[FR Doc. E8-20179 Filed 8-28-08; 8:45 am]
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