[Federal Register: August 29, 2008 (Volume 73, Number 169)][Proposed Rules] [Page 50909-50915]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29au08-20]
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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
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. 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 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 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, 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.
(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]
BILLING CODE 4510-23-P
