Federal Register / Vol. 74, No. 167 / Monday, August 31, 2009 / Proposed Rules 44795 

1Comments are available for review at http:// 

www.regulations.gov. Reference Docket Number: 

DOL–2008–0002. 

2 ‘‘Ex.’’ Refers to exhibits included in the 

rulemaking docket, which can be referenced using 

the URL provided in Footnote 1, supra. 

20001. The materials may also be 

ordered via the AASHTO bookstore 

located at the following URL: http:// 

www.aashto.org/aashto/home.nsf/ 

FrontPage. 

[FR Doc. E9–20713 Filed 8–28–09; 8:45 am] 

BILLING CODE 4910–22–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 Secretary; Office 

of the Assistant Secretary for Policy. 

ACTION: Proposed rule; withdrawal. 

SUMMARY: The Department of Labor 

(‘‘Department’’ or ‘‘DOL’’) is 

withdrawing its proposed rule 

governing DOL agencies’ assessment of 

occupational health risks. The proposed 

rule sought to compile Department 

procedures related to risk assessment 

into a single regulation and included 

new requirements aimed at establishing 

consistent procedures intended to 

promote greater public input and 

awareness of the Department’s health 

rulemakings. 

DATES: This withdrawal is effective on 

August 31, 2009. 

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 number 

above via TTY by calling the toll-free 

Federal Information Relay Service at 

1–800–877–8339. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On August 29, 2008, the Department 

published in the Federal Register (73 

FR 50909 Aug. 29, 2008) a notice of 

proposed rulemaking (NPRM) to codify 

DOL’s internal risk assessment 

procedures for health standard 

rulemakings that address workplace 

exposure to toxic substances and 

hazardous chemicals. The NPRM stated 

that it summarized and would codify 

DOL agencies’ existing risk assessment 

paradigm and requested public 

comment on two specific procedural 

requirements: A new requirement that 

DOL agencies issue an Advance Notice 

of Proposed Rulemaking (ANPRM) as a 

first step whenever developing a health 

standard that would regulate workplace 

exposure to toxic substances or 

hazardous chemicals; and a requirement 

that DOL agencies electronically post all 

documents relied upon to develop such 

health standards within fourteen days of 

each regulatory step. Because the 

Occupational Safety and Health 

Administration (OSHA) and the Mine 

Safety and Health Administration 

(MSHA) are the only two agencies 

within the Department that issue health 

standards related to toxic substances 

and hazardous chemicals, it was 

anticipated that the proposed rule 

would affect only those agencies. 

The Department accepted public 

comment on the NPRM for a period of 

30 days. While some interested parties, 

including members of Congress, urged 

DOL to extend the public comment 

period and requested that the 

Department hold public hearings on the 

proposal, the Department declined these 

requests due to its desire to adhere to 

the originally published timeframe for 

completion of this rulemaking. 

The Department received comments 

in response to the NPRM from a variety 

of sources, including members of 

Congress, private citizens, labor unions, 

worker advocacy organizations, industry 

associations, employer groups, and risk 

assessment experts. The majority of the 

commenters were opposed to the 

rulemaking.1

II. Reasons for Withdrawal of Proposed 

Rule 

After careful review of the comments 

and upon reconsideration of the issues 

involved in this rulemaking, the 

Department has decided to withdraw 

the proposed rule. As described below, 

the two proposed requirements are 

unnecessary. Moreover, given the nature 

of the issues, the Department believes 

that it is more useful to continue 

describing its internal risk assessment 

policies through guidance rather than 

through promulgation of a regulation. 

Proposed ANPRM Requirement. The 

proposal would have required DOL 

agencies to issue an ANPRM in every 

rulemaking for a health standard 

involving toxic substances or hazardous 

chemicals, apart from emergency 

temporary standards. Many commenters 

were opposed to this new requirement. 

See, e.g., Exs. 7.1; 16.1; 42.1; and 48.1.2

Some commenters, including members 

of Congress and Senators, employer 

groups, and worker advocacy 

organizations claimed that an ANPRM is 

not always useful and that imposing an 

ANPRM requirement in a health 

standard rulemaking when it was not 

necessary would unduly delay the 

rulemaking. See, e.g., Exs. 32.1; 37.1; 

and 42.1. They argued that this in turn 

could harm workers by unnecessarily 

delaying the introduction of the health 

protections required by the standard. 

Labor unions and worker advocacy 

organizations also claimed that 

requiring an unnecessary ANPRM 

would divert agency resources from 

other rulemaking efforts. See, e.g., Exs. 

45.1 and 48.1. 

The current policy of both OSHA and 

MSHA is to publish an ANPRM only if 

the agency believes it will be beneficial 

to the rulemaking. This decision is 

made on a case-by-case basis. In light of 

the comments to the proposal and after 

reconsideration of the proposed ANPRM 

requirement, the Department has 

determined that OSHA and MSHA 

should continue to follow their current 

ANPRM policy. 

The Department believes that an 

ANPRM can be a valuable part of the 

rulemaking process in the right 

circumstances, but that an inflexible 

requirement would not fit the varied 

circumstances in which rulemakings are 

conducted and could cause unnecessary 

delays. When an agency lacks important 

information needed to develop an 

effective proposed rule, an ANPRM 

provides one means of attempting to 

obtain that information. However, there 

are times when an agency has sufficient 

information to issue a successful 

proposed rule without taking that step. 

Avoiding an ANPRM in these situations 

allows the agency to more effectively 

use its rulemaking resources. There are 

also many other ways in which OSHA 

and MSHA can obtain needed 

information without using an ANPRM, 

such as holding stakeholder meetings, 

conducting surveys, consulting advisory 

committees, doing site visits, issuing 

Requests for Information, conducting 

peer reviews, and, in the case of OSHA, 

obtaining small entity (including small 

business) input through procedures 

required by the Small Business 

Regulatory Enforcement Fairness Act (5 

U.S.C. 609(b)). By allowing the agency 

to decide whether or not to use an 

ANPRM for a rulemaking, the agency 

retains flexibility to choose the 

information gathering methods that it 

has determined will best fit each 

individual situation. 

Proposed Electronic Posting 

Requirement. The proposal would have 

required the Department to make 


sroberts on DSKD5P82C1PROD with PROPOSALS
44796 Federal Register / Vol. 74, No. 167 / Monday, August 31, 2009 / Proposed Rules 

available, on http://www.regulations.gov 

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.’’ 73 FR at 

50914. Commenters such as some 

industry associations and employer 

groups, who addressed this issue 

generally supported the electronic 

posting requirement and its goal of 

transparency in rulemaking. See, e.g., 

Exs. 11.1; 25.1; 32.1; and 38.1. Several 

commenters, including labor unions, 

other employer groups, and industry 

associations however, pointed out that 

the Department is already required to, 

and does, make rulemaking information 

available online. See, e.g., Exs. 17.1; 

32.1; and 35.1. Indeed, the EGovernment Act of 2002 requires all 

federal agencies to maintain a publicly 

accessible website containing electronic 

dockets for rulemakings. Public Law No. 

107–347, Title II, 201 to 216 (codified as 

44 U.S.C. 3501 note), at 206(d)(1). All 

public comments, as well as ‘‘other 

materials that by agency rule or practice 

are included in the rulemaking docket’’ 

are required to be made available to the 

public via the electronic docket. Public 

Law No. 107–347, Title II, at 

206(d)(2)(A), (B). To implement the EGovernment Act and provide the public 

with a single government-wide access 

point for rulemaking information and 

submissions, federal agencies were 

required to consolidate all electronic 

rulemaking dockets on http:// 

www.regulations.gov. Office of 

Management and Budget (OMB), 

Implementation Guidance for the EGovernment Act of 2002, M–03–18 

(Aug. 1, 2003), available at http:// 

www.whitehouse.gov/omb/memoranda/ 

m03-18.pdf. The E-Government Act 

built on previous efforts to use 

information technology to provide 

citizens with easier access to 

government information and 

participation. See, e.g., OMB, 

Redundant Information Systems 

Relating to On-Line Rulemaking 

Initiative, M–02–08 (May 6, 2002), 

available at http://www.whitehouse.gov/ 

omb/memoranda/m02-08.pdf. 

Pursuant to the E-Government Act, it 

is the practice of both OSHA and MSHA 

to post, in a timely manner, information 

relevant to agency rulemakings on 

http://www.regulations.gov. This 

includes the posting of all scientific 

studies that are relied upon in the 

rulemaking. The Department has 

determined, therefore, that the proposed 

electronic posting requirement is 

duplicative of E-Government Act 

requirements and is not needed. 

Other Requirements. The proposed 

regulatory text also stated that agency 

risk assessments must, when the data 

are available, use industry-by-industry 

evidence relating to working life 

exposures. Proposed 29 CFR 2.9(c)(3), 

73 FR at 50915. Of the commenters that 

discussed the ‘‘industry-by-industry’’ 

language, the majority, including 

members of Congress and Senators, risk 

assessment experts, worker advocacy 

organizations, and labor unions viewed 

it as a departure from the Department’s 

existing longstanding practice of using a 

45-year working life assumption for 

selecting exposure limits for health 

standards. See, e.g., Exs. 18.1; 23; 28.1; 

42.1; and 48.1. Some employer groups 

and industry associations, however, 

expressed support for using industryspecific data to develop working life 

assumptions. See, e.g., Exs. 27.1; 31.1; 

and 35.1. 

Section 6(b)(5) of the Occupational 

Safety and Health Act requires the 

agency to regulate in a manner that 

‘‘most adequately assures * * * that no 

employee will suffer material 

impairment of health or functional 

capacity even if such employee has 

regular exposure to the hazard * * * for 

the period of his working life.’’ 29 

U.S.C. 655(b)(5). The Mine Act has 

nearly identical language, except that it 

refers to miners rather than employees. 

30 U.S.C. 811(a)(6)(A). To implement 

these provisions, it has been the 

Department’s longstanding practice to 

use a general 45-year working life 

assumption. This practice is not based 

on empirical data that most employees 

are exposed to the hazard for 45 years. 

Rather, it is based on the statutory 

directive that ‘‘no employee’’ suffer 

material impairment ‘‘even if’’ such 

employee is exposed for the period of 

his or her working life. The 

Department’s practice of using a 45-year 

working life has won judicial approval. 

See, e.g., Building and Constr. Trades 

Dep’t, AFL–CIO v. Brock, 838 F.2d 1258, 

1264–65 (D.C. Cir. 1987) (explaining 

that the assumption of a 45-year 

working life ‘‘appear[ed] to conform to 

the intent of Congress’’); for examples of 

DOL standards using a 45-year working 

life, see Asbestos, 51 FR 22612, 22648 

(June 20, 1986); Bloodborne Pathogens, 

56 FR 64004, 64031 (Dec. 6, 1991); 

Diesel Particulate Matter Exposure of 

Underground Coal Miners, 66 FR 5526, 

5663–64 (Jan. 19, 2001); Hexavalent 

Chromium, 71 FR 10100, 10224 (Feb. 

28, 2006). 

OSHA and MSHA have not conducted 

separate industry-by-industry analyses 

of working life for their risk 

assessments. The Department has 

consistently rejected the claim that it 

must conduct a separate risk assessment 

for each industry regulated by a 

standard. Public Citizen Health 

Research Group v. U.S. Dep’t of Labor, 

557 F.3d 165, 186–188 (3d Cir. 2009); 

American Dental Ass’n v. Martin, 984 F. 

2d 823, 827 (7th Cir. 1993); UAW v. 

OSHA, 37 F.3d 665, 670 (D.C. Cir. 

1994); Control of Hazardous Energy 

Sources (Lockout/Tagout), OSHA 

Supplemental Statement of Reasons, 58 

FR 16612–02, 16620–16621 (Mar. 30, 

1993). 

Guidance versus Regulation. The 

Department received a small number of 

comments, from risk assessment 

experts, policy groups, and labor unions 

that questioned the need for a regulation 

when it was possible to issue internal 

guidance instead. All of these 

commenters argued that the risk 

assessment rulemaking was unnecessary 

because the Department already has risk 

assessment guidance and because 

guidance rather than regulation is the 

more appropriate format for such 

internal Department procedures. See, 

e.g., Exs. 26.1; 32.1; 46.1; and 48.1. 

Upon reconsideration of this issue, the 

Department has concluded that a risk 

assessment rulemaking is not necessary. 

The Department believes that guidance, 

as opposed to regulation, is a more 

suitable vehicle for its internal risk 

assessment procedures and allows the 

Department more flexibility to quickly 

adapt and improve its risk assessment 

procedures in the future. Compared to 

changes to internal guidance, changes to 

a regulation would take far more time 

and require a lengthy notice and 

comment rulemaking. 

Other Issues. There were a number of 

other issues addressed in public 

comments to the proposed rule. These 

issues included: (1) Whether the rule 

was a ‘‘significant regulatory action’’ 

under Executive Order 12866, thus 

requiring a cost/benefit analysis before 

promulgating the rule; (2) whether the 

rule was substantive or procedural and, 

if substantive, whether proper 

rulemaking procedures were followed; 

(3) whether the rule was appropriately 

issued under 5 U.S.C. 301; and (4) 

whether the Assistant Secretary for 

Policy had a proper delegation of 

authority to issue the rule. The 

Department notes that these and other 

issues raised by commenters, while 

important, are no longer relevant given 

the Department’s decision to terminate 

the rulemaking. 

Withdrawal. For the reasons 

discussed above, the Department is 

withdrawing its risk assessment 


sroberts on DSKD5P82C1PROD with PROPOSALS
Federal Register / Vol. 74, No. 167 / Monday, August 31, 2009 / Proposed Rules 44797 

rulemaking, effective on August 31, 

2009. 

Authority and Signature. 

Megan Uzzell, 

Acting Assistant Secretary for Policy. 

[FR Doc. E9–20923 Filed 8–28–09; 8:45 am] 

BILLING CODE 4510–23–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

32 CFR Part 199 

[DoD–2008–HA–0090; RIN 0720–AB23] 

TRICARE; Off-Label Uses of Devices; 

Partial List of Examples of Unproven 

Drugs, Devices, and Medical 

Treatments or Procedures 

AGENCY: Office of the Secretary, 

Department of Defense. 

ACTION: Proposed rule. 

SUMMARY: The Department of Defense is 

publishing this proposed rule to revise 

the definition of ‘‘unlabeled or off-label 

drug’’ to ‘‘off-label use of a drug or 

device.’’ This revision is consistent with 

the regulatory framework under the 

Federal Food, Drug, and Cosmetic Act. 

Additionally, this rule removes the 

partial list of examples of unproven 

drugs, devices, and medical treatments 

or procedures proscribed in TRICARE 

regulations. As it is determined that 

reliable evidence demonstrates that 

previously unproven drugs, devices, 

and medical treatments or procedures 

have proven medical effectiveness, 

TRICARE has removed them from the 

list and authorized medically necessary 

care. This revision removing the partial 

list is necessary as the list will never be 

completely current, and is only a partial 

list of examples. The removal of this 

partial list does not change or eliminate 

any benefits that are currently available 

under the TRICARE program. 

DATES: Written comments received at 

the address indicated below by October 

30, 2009 will be accepted. 

ADDRESSES: You may submit comments, 

identified by docket number and/or 

Regulatory Information Number (RIN) 

number and title, by either of the 

following methods: 

• Federal Rulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Federal Docket Management 

System Office, 1160 Defense Pentagon, 

Washington, DC 20301–1160. 

Instructions: All submissions received 

must include the agency name and 

docket number or RIN for this Federal 

Register document. The general policy 

for comments and other submissions 

from members of the public is to make 

these submissions available for public 

viewing on the Internet at http:// 

www.regulations.gov as they are 

received without change, including any 

personal identifiers or contact 

information. 

FOR FURTHER INFORMATION CONTACT: 

Rene ́ L. Morrell, TRICARE Management 

Activity, Medical Benefits and 

Reimbursement Branch, telephone (303) 

676–3618. 

SUPPLEMENTARY INFORMATION: This 

proposed rule revises the definition of 

‘‘unlabeled or off-label drug’’ to ‘‘offlabel use of a drug or device.’’ This 

revision is consistent with the 

regulatory framework under the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

301 et seq.). Additionally, this proposed 

rule removes the partial list of examples 

of unproven drugs, devices, and medical 

treatments or procedures proscribed 

under § 199.4(g)(15). 

Off-Label Uses of Devices 

On January 6, 1997, the Office of the 

Secretary of Defense published a final 

rule in the Federal Register (62 FR 627– 

631) clarifying the TRICARE exclusion 

of unproven drugs, devices, and medical 

treatments or procedures and adding the 

TRICARE definition of unlabeled or offlabel drugs. This rule also added the 

provision for coverage of unlabeled or 

off-label uses of drugs that are Food and 

Drug Administration (FDA) approved 

drugs that are prescribed or 

administered by a health care 

practitioner and are used for indications 

or treatments not included in the 

approved labeling. We are now 

modifying the definition of ‘‘unlabeled 

or off-label drug’’ to ‘‘off-label use of a 

drug or device’’ to be consistent with 

the regulatory framework under the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 301 et seq.) However, this 

proposed rule does not present new 

agency policy. Rather, it corrects an 

error and omission from the current 

rule. Coverage is limited to those 

indications for which there is reliable 

evidence, as defined in section 199.2, 

sufficient to establish that the off-label 

use is safe, effective, and in accordance 

with nationally accepted standards of 

practice in the medical community. In 

addition, the off-label use must be 

reviewed for medical necessity. 

Partial List of Examples of Unproven 

Drugs, Devices, and Medical 

Treatments or Procedures 

By law, TRICARE can only cost-share 

medically necessary supplies and 

services. Any drug, device, and medical 

treatment or procedure, the safety and 

efficacy of which have not been 

established, as described in 

§ 199.4(g)(15), is unproven and cannot 

be cost-shared by TRICARE except as 

authorized under § 199.4(e)(26). The 

current regulation and program policy 

provide a partial list of examples of 

unproven drugs, devices, and medical 

treatments or procedures that are 

excluded from benefits. The intent of 

this partial list was to provide 

information on specific examples of 

emerging drugs, devices, and medical 

treatments or procedures determined to 

be unproven by TRICARE based on 

review of current reliable evidence. Due 

to the rapid and extensive changes in 

medical technology it is not feasible to 

maintain this list in the regulation. 

Removal of this partial list of examples 

does not change the exclusion of 

unproven drugs, devices, and medical 

treatments or procedures. Removal of 

the partial list of examples does not 

change the process TRICARE follows in 

determining for purposes of benefit 

coverage when a drug, device, and 

medical treatment or procedure has 

moved from the status of unproven to 

proven medical effectiveness. The intent 

of this revision is to ensure that benefit 

determinations are made based on 

current reliable evidence rather than 

relying on outdated regulatory and 

policy provisions. 

Regulatory Procedures 

Executive Order 12866, ‘‘Regulatory 

Planning and Review’’ 

Section 801 of Title 5, U.S.C., and 

Executive Order (E.O.) 12866 require 

certain regulatory assessments and 

procedures for any major rule or 

significant regulatory action, defined as 

one that would result in an annual effect 

of $100 million or more on the national 

economy or which would have other 

substantial impacts. It has been certified 

that this rule is not an economically 

significant rule, however, it is a 

regulatory action which has been 

reviewed by the Office of Management 

and Budget as required under the 

provisions of E.O. 12866. 

Sec. 202, Public Law 104–4, ‘‘Unfunded 

Mandates Reform Act’’ 

It has been certified that this rule does 

not contain a Federal mandate that may 

result in the expenditure by State, local 

and tribal governments, in aggregate, or 

by the private sector, of $100 million or 

more in any one year. 


sroberts on DSKD5P82C1PROD with PROPOSALS