Federal Register / Vol. 73, No. 169 / Friday, August 29, 2008 / Proposed Rules 50909 

1Presidential/Congressional Commission on Risk 

Assessment and Risk Management, Framework for 

Environmental Health Risk Management, 2 Final 

Report 131–36 (1997). 

2http://www.whitehouse.gov/omb/fedreg/2005/ 

011405_peer.pdf. 

3U.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. 

4OMB/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. 

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. 

Inspection Document (SID),’’ Volume I, 

Revision 6, dated July 2005, are acceptable 

for compliance with the corresponding 

requirements of this AD. 

Alternative Methods of Compliance 

(AMOCs) 

(p)(1) The Manager, Los Angeles ACO, 

FAA, ATTN: Dara Albouyeh, Aerospace 

Engineer, Airframe Branch, ANM–120L, 

FAA, Los Angeles Aircraft Certification 

Office, 3960 Paramount Boulevard, 

Lakewood, California 90712–4137; telephone 

(562) 627–5222; fax (562) 627–5210; has the 

authority to approve AMOCs for this AD, if 

requested using the procedures found in 14 

CFR 39.19. 

(2) To request a different method of 

compliance or a different compliance time 

for this AD, follow the procedures in 14 CFR 

39.19. Before using any approved AMOC on 

any airplane to which the AMOC applies, 

notify your appropriate principal inspector 

(PI) in the FAA Flight Standards District 

Office (FSDO), or lacking a PI, your local 

FSDO. 

(3) An AMOC that provides an acceptable 

level of safety may be used for any repair 

required by this AD, if it is approved by an 

Authorized Representative for the Boeing 

Commercial Airplanes Delegation Option 

Authorization Organization who has been 

authorized by the Manager, Los Angeles 

ACO, to make those findings. For a repair 

method to be approved, the repair must meet 

the certification basis of the airplane and 14 

CFR 25.571, Amendment 45, and the 

approval must specifically refer to this AD. 

(4) AMOCs approved previously in 

accordance with AD 93–01–15 are approved 

as AMOCs for the corresponding provisions 

of this AD. 

Issued in Renton, Washington, on August 

21, 2008. 

Kevin Hull, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. E8–20085 Filed 8–28–08; 8:45 am] 

BILLING CODE 4910–13–P 

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. 

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

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 securityrelated 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 


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50910 Federal Register / Vol. 73, No. 169 / Friday, August 29, 2008 / Proposed Rules 

9http://www.whitehouse.gov/omb/fedreg/2005/ 

011405_peer.pdf. 10http://www.dol.gov/informationquality.htm. 11OMB/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. 

12 5 U.S.C. 553(b)(A). 

13See, 5 U.S.C. 601 (2000). 

14See, 29 U.S.C. 652(8) (2000) and § 655(b)(3) 

(2000). 

15See, 30 U.S.C. 811(a)(3) (2000). 

16 42 U.S.C. 7412 note, Pub. L. 101–549, § 303, 

Nov. 15, 1990. 

17Presidential/Congressional Commission on 

Risk Assessment and Risk Management, Framework 

for Environmental Health Risk Management, 2 Final 

Report 131–36 (1997) (Commission on Risk Report). 

18 29 U.S.C. 655 (2000). 

19 30 U.S.C. 811 (2000). 

20OMB/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. 

21http://www.whitehouse.gov/omb/fedreg/2005/ 

011405_peer.pdf. 

22http://www.dol.gov/informationquality.htm. 

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

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

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. 

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

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. 


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23http://www.whitehouse.gov/omb/fedreg/2005/ 

011405_peer.pdf. 24http://www.dol.gov/informationquality.htm. 

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

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. 

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 


pwalker on PROD1PC71 with PROPOSALS
50912 Federal Register / Vol. 73, No. 169 / Friday, August 29, 2008 / Proposed Rules 

25U.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. 

26See 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). 

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. 

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 doseresponse 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. 

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 


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Federal Register / Vol. 73, No. 169 / Friday, August 29, 2008 / Proposed Rules 50913 

28 Id. at 614–15. 

29 Id. at 655. 

30See, American Textile Mfrs. Inst., Inc. v. 

Donovan, 452 U.S. 490, 509, 101 S.Ct. 2478, 2490–

91 (1981). 

31 Id. 

32 42 U.S.C. 300g–1(b)(3)(A) and (B) (2000). 

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). 

34http://www.dol.gov/asp/peer-review/index.htm. 

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

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. 

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, peerreviewed 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

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. 

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, 


pwalker on PROD1PC71 with PROPOSALS
50914 Federal Register / Vol. 73, No. 169 / Friday, August 29, 2008 / Proposed Rules 

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). 

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. 

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 nonagency 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 § 2.9 to subpart A to read as 

follows: 

§ 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. 


pwalker on PROD1PC71 with PROPOSALS
Federal Register / Vol. 73, No. 169 / Friday, August 29, 2008 / Proposed Rules 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] 

BILLING CODE 4510–23–P 

DEPARTMENT OF THE INTERIOR 

Office of Surface Mining Reclamation 

and Enforcement 

30 CFR Part 946 

[VA–126–FOR; Docket ID OSM–2008–0012] 

Virginia Regulatory Program 

AGENCY: Office of Surface Mining 

Reclamation and Enforcement (OSM), 

Interior. 

ACTION: Proposed rule; public comment 

period and opportunity for public 

hearing on proposed amendment. 

SUMMARY: We are announcing receipt of 

a proposed amendment to the Virginia 

regulatory program under the Surface 

Mining Control and Reclamation Act of 

1977 (SMCRA or the Act). The 

amendment revises the Virginia Coal 

Surface Mining Reclamation 

Regulations pertaining to ownership 

and control, valid existing rights, selfbonding, and availability of records. 

Virginia intends to revise its program to 

be consistent with the corresponding 

Federal regulations and SMCRA and is 

responding, in part, to 30 CFR Part 732 

letters. 

This document gives the times and 

locations that the Virginia program and 

this submittal are available for your 

inspection, the comment period during 

which you may submit written 

comments, and the procedures that we 

will follow for the public hearing, if one 

is requested. 

DATES: We will accept written 

comments until 4 p.m., local time, 

September 29, 2008. If requested, we 

will hold a public hearing on September 

23, 2008. We will accept requests to 

speak until 4 p.m., e.s.t., on September 

15, 2008. 

ADDRESSES: You may submit comments, 

identified by ‘‘VA–126–FOR/OSM–

2008–0012’’ by any of the following 

methods: 

• E-mail: ebandy@osmre.gov. 

• Mail/Hand Delivery: Earl Bandy, 

Knoxville Field Office, Office of Surface 

Mining Reclamation and Enforcement, 

710 Locust Street, 2nd Floor, Knoxville, 

Tennessee 37902, Telephone: (865) 545–

4103. 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. The proposed rule 

has been assigned Docket ID OSM–

2008–0012. If you would like to submit 

comments through the Federal 

eRulemaking Portal, go to http:// 

www.regulations.gov and do the 

following. Click on the ‘‘Advanced 

Docket Search’’ button on the right side 

of the screen. Type in the Docket ID 

OSM–2008–0012 and click the 

‘‘Submit’’ button at the bottom of the 

page. The next screen will display the 

Docket Search Results for the 

rulemaking. If you click on OSM–2008–

0012, you can view the proposed rule 

and submit a comment. You can also 

view supporting material and any 

comments submitted by others. 

Instructions: All submissions received 

must include the agency docket number 

‘‘OSM–2008–0012/VA–126–FOR’’ for 

this rulemaking. For detailed 

instructions on submitting comments 

and additional information on the 

rulemaking process, see the ‘‘Public 

Comment Procedures’’ section in this 

document. You may also request to 

speak at a public hearing by any of the 

methods listed above or by contacting 

the individual listed under FOR FURTHER

INFORMATION CONTACT. 

Docket: You may review copies of the 

Virginia program, this submission, a 

listing of any scheduled public hearings, 

and all written comments received in 

response to this document at OSM’s 


pwalker on PROD1PC71 with PROPOSALS