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THE SECRET RULE: IMPACT OF THE

DEPARTMENT OF LABOR’S WORKER

HEALTH RISK ASSESSMENT PROPOSAL

HEARING

BEFORE THE

SUBCOMMITTEE ON WORKFORCE PROTECTIONS 

COMMITTEE ON 

EDUCATION AND LABOR

U.S. HOUSE OF REPRESENTATIVES

ONE HUNDRED TENTH CONGRESS

SECOND SESSION

HEARING HELD IN WASHINGTON, DC, SEPTEMBER 17, 2008

Serial No. 110–110

Printed for the use of the Committee on Education and Labor

(

Available on the Internet: 

http://www.gpoaccess.gov/congress/house/education/index.html 

(II)

COMMITTEE ON EDUCATION AND LABOR 

GEORGE MILLER, California, Chairman

Dale E. Kildee, Michigan, Vice Chairman 

Donald M. Payne, New Jersey 

Robert E. Andrews, New Jersey 

Robert C. ‘‘Bobby’’ Scott, Virginia 

Lynn C. Woolsey, California 

Rube ́n Hinojosa, Texas 

Carolyn McCarthy, New York 

John F. Tierney, Massachusetts 

Dennis J. Kucinich, Ohio 

David Wu, Oregon 

Rush D. Holt, New Jersey 

Susan A. Davis, California 

Danny K. Davis, Illinois 

Rau ́l M. Grijalva, Arizona 

Timothy H. Bishop, New York 

Linda T. Sa ́nchez, California 

John P. Sarbanes, Maryland 

Joe Sestak, Pennsylvania 

David Loebsack, Iowa 

Mazie Hirono, Hawaii 

Jason Altmire, Pennsylvania 

John A. Yarmuth, Kentucky 

Phil Hare, Illinois 

Yvette D. Clarke, New York 

Joe Courtney, Connecticut 

Carol Shea-Porter, New Hampshire 

Howard P. ‘‘Buck’’ McKeon, California, 

Senior Republican Member 

Thomas E. Petri, Wisconsin 

Peter Hoekstra, Michigan 

Michael N. Castle, Delaware 

Mark E. Souder, Indiana 

Vernon J. Ehlers, Michigan 

Judy Biggert, Illinois 

Todd Russell Platts, Pennsylvania 

Ric Keller, Florida 

Joe Wilson, South Carolina 

John Kline, Minnesota 

Cathy McMorris Rodgers, Washington 

Kenny Marchant, Texas 

Tom Price, Georgia 

Luis G. Fortun ̃ o, Puerto Rico 

Charles W. Boustany, Jr., Louisiana 

Virginia Foxx, North Carolina 

John R. ‘‘Randy’’ Kuhl, Jr., New York 

Rob Bishop, Utah 

David Davis, Tennessee 

Timothy Walberg, Michigan 

[Vacancy]

Mark Zuckerman, Staff Director 

Sally Stroup, Republican Staff Director 

SUBCOMMITTEE ON WORKFORCE PROTECTIONS 

LYNN C. WOOLSEY, California, Chairwoman

Donald M. Payne, New Jersey 

Timothy H. Bishop, New York 

Carol Shea-Porter, New Hampshire 

Phil Hare, Illinois 

Joe Wilson, South Carolina, 

Ranking Minority Member 

Tom Price, Georgia 

John Kline, Minnesota 

(III)

C O N T E N T S 

Page

Hearing held on September 17, 2008 ..................................................................... 1

Statement of Members: 

Wilson, Hon. Joe, ranking minority member, Subcommittee on Workforce 

Protections ..................................................................................................... 4

Prepared statement of ............................................................................... 5

Additional submissions: 

Letter dated July 17, 2008, to Chairman Miller from Mr. 

Sequeira ........................................................................................... 41

Letter dated September 5, 2008, to Chairman Kennedy from 

Mr. Sequeira ................................................................................... 43

Letter dated September 5, 2008, to Chairman Miller from Mr. 

Sequeira ........................................................................................... 45

Woolsey, Hon. Lynn C., Chairwoman, Subcommittee on Workforce Protections ................................................................................................................ 1

Prepared statement of ............................................................................... 3

Statement of Witnesses: 

Johnson, Randel K., vice president of labor, immigration and employee 

benefits, U.S. Chamber of Commerce .......................................................... 27

Prepared statement of ............................................................................... 29

Monforton, Celeste, MPH, DrPH, researcher, department of environmental and occupational health, George Washington University School 

of Public Health & Health Services ............................................................. 14

Prepared statement of ............................................................................... 16

Seminario, Peg, director of safety and health, AFL–CIO .............................. 31

Prepared statement of ............................................................................... 33

Sequeira, Hon. Leon R., Assistant Secretary for Policy, U.S. Department 

of Labor .......................................................................................................... 6

Prepared statement of ............................................................................... 8

(1)

THE SECRET RULE: IMPACT OF THE

DEPARTMENT OF LABOR’S WORKER 

HEALTH RISK ASSESSMENT PROPOSAL 

Wednesday, September 17, 2008

U.S. House of Representatives 

Subcommittee on Workforce Protections 

Committee on Education and Labor 

Washington, DC

The subcommittee met, pursuant to call, at 10:05 a.m., in room 

2175, Rayburn House Office Building, Hon. Lynn Woolsey [chairwoman of the subcommittee] presiding. 

Present: Representatives Woolsey, Payne, Hare, and Wilson. 

Also Present: Representative Scott. 

Staff Present: Aaron Albright, Press Secretary; Tylease Alli, 

Hearing Clerk; Jordan Barab, Senior Labor Policy Advisor; Jody 

Calemine, Labor Policy Deputy Director; Lynn Dondis, Senior Policy Advisor, Subcommittee on Workforce Protections; David 

Hartzler, Systems Administrator; Jessica Kahanek, Press Assistant; Brian Kennedy, General Counsel; Therese Leung, Labor Policy 

Advisor; Sara Lonardo, Junior Legislative Associate, Labor; Joe 

Novotny, Chief Clerk; Meredith Regine, Junior Legislative Associate, Labor; Michele Varnhagen, Labor Policy Director; Robert 

Borden, Minority General Counsel; Cameron Coursen, Minority Assistant Communications Director; Ed Gilroy, Minority Director of 

Workforce Policy; Rob Gregg, Minority Senior Legislative Assistant; 

Alexa Marrero, Minority Communications Director; Jim Paretti, 

Minority Workforce Policy Counsel; Chris Perry, Minority Legislative Assistant; Linda Stevens, Minority Chief Clerk/Assistant to 

the General Counsel; and Loren Sweatt, Minority Professional Staff 

Member. 

Chairwoman WOOLSEY. A quorum is present. The hearing of the 

Subcommittee on Workforce Protection will come to order, and I 

will begin with my opening remarks and then I will yield to my 

ranking member. 

Thank you all for being here. It is sort of the end of the school 

year around here. Everybody is excited and forgetting to come to 

their committee meeting, yes, but they will be here. I was assured 

of that. And I thank you because this is more important to you 

than our getting out of here for the next few months. 

I have called this hearing today on the Department of Labor’s 

proposed risk assessment regulation because, quite frankly, I am 

troubled by the Agency’s attempt to rush through this rule without 

2

a full consideration of its effect on the health and safety of the 

American worker. This proposed rule has, without explanation, 

leapfrogged ahead of many other worker protection standards that 

OSHA should have been working on for the last eight years, including a standard for diacetyl, the long delayed silica standard, the 

long delayed beryllium standard and the long delayed crane standard. 

By now most of you know why the proposed rule has been 

dubbed the secret rule. That is what we call it around here, and 

now it has become the name of the rule. Because the secret rule 

was developed by DOL’s Office of Policy with little input from anyone, not even its own experts at OSHA and MSHA. And according 

to documents recently provided by the committee throughout the 

process, DOL consulted with only one outsider during its consideration of the proposal. This was a lawyer representing industry. 

When the Secretary’s office finally showed the rule to its own experts at OSHA and MSHA, those experts disapproved the rule and 

urged DOL not to proceed. But the DOL policy department ignored 

their input, pushed ahead anyway. 

The Department was so determined to put this rule in place that 

it even ignored a deadline set by White House Chief of Staff Josh 

Bolten. Chief Bolten prohibited all Agencies from proposing regulations after June 1, 2008, except in extraordinary circumstances. I 

am hoping that Mr. Sequeira is prepared to explain to us why extraordinary circumstances exist to justify this rule. 

Now, it is important to note that this proposed rule developed in 

secret—we are going to say this many times today—was only 

brought to the public’s attention in early July when the Office of 

Management and Budget, OMB, which reviews all proposed rules 

posted the rule on its Web site. Actually it did not post the rule. 

It only posted the title. Uh-huh, secret. So Chairman Miller and 

Senator Kennedy wrote to DOL and asked for specific information 

on the rule and how it came about. But no documents were forthcoming until the day before the rule was published in the Federal 

Register on August 29. So, many of us have spent the summer 

scratching our heads about the content of the proposed rule. 

Now we have the really bad news. Only 30 days to comment on 

this misguided proposal. Only 30 days to comment on a risk assessment regulation that would significantly lengthen the many years 

that it currently takes to issue standards. And only 30 days to comment on a regulation that will significantly affect the ability of 

OSHA and MSHA to protect workers from deadly health hazards. 

In addition, DOL has decided not to provide an opportunity for 

a public hearing. This is unprecedented in the history of significant 

OSHA and MSHA standards. We have a chart up there on the 

screen which shows the usual procedures DOL has chosen to ignore 

in quickly pushing through this proposed regulation. These procedures, as you can see, include Executive Order 12866, the Regulatory Flexibility Act, the Administrative Procedure Act, the OSH 

Act, the Mine Safety and Health Act and the Bolten memo. 

Chairman Miller and Senator Kennedy and Senator Murray and 

I have recently sent a letter to DOL asking for a public hearing 

and for an extension of the comment period, and other groups have 

3

done so as well. I hope that the Assistant Secretary will have some 

good news for us on that front. 

Of course the irony of all of this is that during the entire Bush 

administration OSHA has not issued a single new health standard 

except for one that was issued under a court ordered deadline. And 

MSHA has issued only one new health standard, and that was on 

asbestos that belatedly brought the mine standard up to the level 

that other American workers have enjoyed for over 20 years. 

In April 2007, this subcommittee had a hearing on OSHA’s failure to issue standards. And a young man, Eric Peoples, who is a 

former worker in a popcorn factory, testified about his losing struggle with popcorn lung disease caused by his exposure to diacetyl, 

a chemical that is used in the microwave popcorn manufacturing 

process. Sitting beside Eric at the hearing was OSHA Administrator Ed Foulke, who assured us that the Agency was fully committed to achieving its regulatory goals. Following the April 2007 

hearing, many of us concluded that OSHA intended to take no action to prevent workers from exposure to diacetyl. 

So I introduced legislation that would require OSHA to issue an 

interim standard within 90 days and a final standard within no 

less than two years. As we were about to vote on the bill, which 

passed in the House, OSHA announced that it would begin rulemaking and shortly thereafter promised to have a draft ready for 

Small Business review by January 2008. But here we are September with no draft of a standard for diacetyl. But we have the 

secret rule which is being propelled forward at lightning speed. 

Sadly, we know where this administration’s priorities are and they 

are not with the American people. 

Our witness will further explain this secret rule, we hope, and 

we look forward to hearing all of our witnesses’ testimony. With 

that, I defer to Ranking Member Joe Wilson for his opening statement. 

[The statement of Ms. Woolsey follows:]

Prepared Statement of Hon. Lynn C. Woolsey, Chairwoman, Subcommittee 

on Workforce Protections 

I’ve called this hearing today on DOL’s proposed risk assessment regulation because, quite frankly, I am troubled by the Agency’s attempt to rush through this 

rule without a full consideration of its effect on the health and safety of the American worker. 

This proposed rule has without explanation leapfrogged ahead of many other 

worker protection standards that OSHA should have been working on for the last 

8 years, including: 

• A standard for diacetyl, 

• The long delayed silica standard, 

• The long delayed beryllium standard, and 

• The long delayed crane standard. By now most of you know why the proposed 

rule has been dubbed the ‘‘secret rule.’’ It was developed by DOL’s Office of Policy 

with little input from anyone, not even its own experts at OSHA and MSHA. 

And according to documents recently provided to the Committee, throughout the 

process, DOL only consulted with one outsider. And this was a lawyer representing 

the industry. When the Secretary’s office finally showed the rule to its own experts 

at OSHA and MSHA, those experts disapproved the rule and urged DOL not to proceed. But the DOL Policy Department apparently ignored them and pushed ahead 

anyway. 

Now, it is important to note that this proposed rule—-developed in secret—-was 

only brought to the public’s attention in early July when the Office of Management 

and Budget (OMB), which reviews all proposed rules, posted the rule on its website. 

Actually, it did not post the rule, but only its title. 

4

And so, Chairman Miller and Senator Kennedy wrote to DOL and asked for specific information on the rule and how it came about. But no documents were forthcoming until the day before the rule was published in the Federal Register on August 29. 

So many of us have spent the summer scratching our heads about the content of 

the proposed rule. Well, now we have the bad news, but only 30 days to comment 

on this misguided proposal. Only 30 days to comment on a risk assessment regulation that would significantly lengthen the many years it takes currently to issue 

standards. 

And only 30 days to comment on a regulation that will significantly affect the 

ability of OSHA and MSHA to protect workers from deadly health hazards. The Department was so determined to put this rule in place that it even ignored a deadline 

set by 

White House Chief of Staff John Bolten who prohibited all agencies from proposing regulations after June 1, 2008, except in extraordinary circumstances. In addition, DOL has decided not to provide an opportunity for a public hearing. 

This is unprecedented in the history of significant OSHA or MSHA standards. We 

have a chart, which shows the usual procedures DOL has chosen to ignore in its 

effort to quickly push through this proposed rule. 

In addition to Mr. Bolten’s memo, DOL has ignored the orderly processes set outlined in Executive Order 12866, the Regulatory Flexibility Act, the Administrative 

Procedure Act, the OSH Act and the Mine Safety and Health Act. 

Chairman Miller, Senator Kennedy, Senator Murray and I have recently sent a 

letter to DOL asking for a public hearing and for an extension of the comment period. Other groups have done so as well. I hope that Assistant Secretary Sequeira 

will have good news for us on that front. 

Of course, the irony of all of this is that during the entire Bush Administration, 

OSHA has not issued a single new health standard, except for one that was issued 

under a court-ordered deadline. 

And MSHA has issued only one new health standard—on asbestos—that belatedly 

brought the mine standard up to the level that other American workers have enjoyed for over 20 years. 

In April, 2007, this subcommittee had a hearing on OSHA’s failure to issue standards. 

And Eric Peoples, a former worker in a popcorn factory testified about his losing 

struggle with ‘‘popcorn lung’’ disease caused by his exposure to diacetyl, a chemical 

used in the microwave popcorn manufacturing process. 

Sitting beside Eric was OSHA Administrator Ed Foulke who assured us that the 

Agency was fully committed to achieving its regulatory goals. 

Following the April 2007 hearing, many of us concluded that OSHA intended to 

take no action to prevent workers from exposure to diacetyl. 

And, so I introduced legislation that would require OSHA to issue an interim 

standard within 90 days, and a final standard within two years. 

As we were about to vote on the bill, which passed in the House, OSHA announced that it would begin rulemaking and shortly thereafter promised to have 

draft ready for small business review by January 2008. 

But here we are in September with no draft of a standard for diacytel but we have 

the secret rule, which is being propelled forward at lightning speed. 

Sadly, we know where this Administration’s priorities are, and they are not with 

American workers. 

Our witnesses will further explain this ‘‘secret rule,’’ and I look forward to their 

testimony. 

With that, I defer to the ranking member, Joe Wilson, for his opening statement. 

Mr. WILSON. Good morning, Chairwoman Woolsey. And thank 

you for recognizing me. I want to thank you for holding this hearing today and thank our witnesses for taking the time to appear 

before us. Today is Constitution Day, and it is only right that we 

have a hearing ensuring that citizens are able to redress their government. I hope we will all take a few moments today to reflect on 

the importance of this document to our lives. 

On August 29, 2008, the Department of Labor formally proposed 

to change its internal risk assessment policy and provided that proposal for stakeholder input. Prior to this action, however, there was 

5

an unnecessary conflict over so-called secret rulemaking, to include 

the chairman of this committee introducing legislation to halt a 

draft proposal leaked to the Washington Post. The Department 

should be commended for subjecting internal policy to outside scrutiny when it simply could have changed the policy without any notice. That, ladies and gentlemen, would have actually been secret 

rulemaking. 

While I will not prejudge the outcome of this rulemaking, I will 

say that I support the concept of greater transparency in the rulemaking process. The Department’s risk assessment proposal will 

require an Advanced Notice of Proposed Rulemaking, ANPRM—

and so here we go another acronym, Madam Chairwoman, for us 

to learn—in order for all stakeholders to provide input during the 

regulatory process. This will ensure that all of the studies used as 

a foundation for rulemaking are available for review and I hope 

will serve to improve rulemaking in the future. 

I welcome our witnesses today and look forward to a discussion 

on how to improve the use of risk assessment in Federal regulations. 

[The statement of Mr. Wilson follows:]

Prepared Statement of Hon. Joe Wilson, Ranking Republican Member, 

Subcommittee on Workforce Protections 

Good morning Chairwoman Woolsey. I want to thank you for holding this hearing 

today and thank our witnesses for taking the time to appear before us. Today is 

Constitution Day and it is only right that we have a hearing ensuring that citizens 

are able to redress their government. I hope we will all take a few moments today 

to reflect on the importance of this document in our lives. 

On August 29, 2008, the Department of Labor formally proposed to change its internal risk assessment policy and provided that proposal for stakeholder input. Prior 

to this action, however, there was an unnecessary conflict over so-called secret rulemaking, to include the Chairman of this Committee introducing legislation to halt 

a draft proposal leaked to The Washington Post. The Department should be commended for subjecting internal policy to outside scrutiny, when it simply could have 

just changed the policy without any notice. That, ladies and gentleman, would have 

actually been ‘‘secret rulemaking.’’

While I will not prejudge the outcome of this rulemaking, I will say that I support 

the concept of greater transparency in the rulemaking process. The Department’s 

risk assessment proposal will require an advanced notice of proposed rulemaking 

(ANPRM) in order for all stakeholders to provide input during the regulatory process; will ensure that all of the studies used as a foundation for rulemaking are 

available for review; and I hope will serve to improve rulemaking in the future. 

I welcome our witnesses today and look forward to a discussion on how to improve 

the use of risk assessment in federal regulations. 

Chairwoman WOOLSEY. Thank you, Mr. Wilson. Without objection, all Members will have 14 days to submit additional material 

for the hearing record. 

Now I would like to introduce our very distinguished panel of 

witnesses that are with us today, and I will read their biographies 

in the order that they will present. And then after their biographies, we will get started. 

But let’s talk about the lighting system, which is not new to any 

of you up there, I believe. But we have a lighting system that is 

the fiveminute rule. Everyone, including Members, is limited to five 

minutes of presentation or questioning. The green light is illuminated when you begin to speak. The yellow light goes on when you 

have a minute left. And when the red light turns on in front of 

6

you—you each have your own little lighting system—you will know 

that it is time to wrap up or conclude. Now we don’t, you know, 

open the floor and you drop through it at the red light, but we do 

know that that is about time to end. And the same thing goes for 

the Members up here. If we choose to use our whole five minutes 

making a speech, then there is no time left to ask questions. So we 

will go from there. 

So first let me introduce all of you. Leon Sequeira, Assistant Secretary for Policy at the U.S. Department of Labor, a position he has 

held since February of last year. He previously served as Deputy 

Assistant Secretary of Policy at DOL and as Counsel to the Senate 

Rules Committee. Mr. Sequeira holds a Bachelor’s Degree from 

Northwest Missouri State University and a J.D. from the George 

Washington University. 

Celeste Monforton is a lecturer and researcher at the George 

Washington University School of Public Health. Dr. Monforton 

worked at OSHA from 1991 to 1995 as a Policy Analyst and at 

MSHA as a Special Assistant to the Assistant Secretary of Labor 

from 1996 to 2001. 

She earned her Master’s of Public Health in 2004 and her doctorate of public health in 2008 from George Washington’s School of 

Public Health. 

Randel Johnson is Vice President for Labor, Immigration and 

Employee Benefits at the U.S. Chamber of Commerce. Before joining the Chamber, Mr. Johnson was the Republican Labor Counsel 

and Coordinator for the full Education and Labor Committee here 

in the House. He is a graduate of Denison University and the 

Maryland University School of Law and received his Master’s of 

Law in labor relations from the Georgetown University Law Center. 

Margaret Seminario is the Director of Occupational Health and 

Safety for the AFL-CIO, where she has worked since 1977. Ms. 

Seminario has directed the organization’s efforts on safety and 

health since 1990. She served on the National Advisory Committee 

on Occupational Safety and Health and was trained as an industrial hygienist at the Harvard School of Public Health. 

We will now begin with you, Mr. Secretary. 

STATEMENT OF HON. LEON R. SEQUEIRA, ASSISTANT 

SECRETARY FOR POLICY, U.S. DEPARTMENT OF LABOR 

Mr. SEQUEIRA. Good morning, Madam Chair and members of the 

subcommittee. Thank you for the opportunity to appear before you 

today to discuss the Department of Labor’s recent notice of proposed rulemaking regarding our internal procedures for conducting 

rulemakings that involve the regulation of potential workplace exposure to toxins. I appreciate the opportunity to testify today to 

offer some facts about the Department’s proposal, especially given 

the widespread inaccurate speculation and misleading descriptions 

of this rulemaking. 

The Department’s proposed rule is short and simple. It codifies 

existing best practices into a single easy-to-reference regulation 

and includes two provisions to establish consistent procedures that 

promote greater public input and awareness of the Department’s 

health rulemakings. Specifically, those provisions are, one, the 

7

issuance of an Advanced Notice of Proposed Rulemaking as part of 

the health standard rulemaking involving the regulation of workplace toxins and, two, the electronic posting of all documents the 

Department relies upon when developing these health standards. 

It is important to note, contrary to many misleading reports, that 

this proposal does not affect the substance or methodology of risk 

assessments and it does not weaken any health standard. Much of 

the criticism of this proposal appears to reflect either a profound 

misunderstanding of the Federal rulemaking process or a deliberate mischaracterization of the Department’s proposal. 

The Department’s use of an Advanced Notice of Proposed Rulemaking is not new. In fact, OSHA frequently issues an Advanced 

Notice of Proposed Rulemaking when regulating workplace exposure to toxins, and it has done so since the early 1970s. In fact, 

several of the health standards most recently issued by the Department began with an Advanced Notice of Proposed Rulemaking. So 

those who would suggest that this is some sort of unheard of new 

process are being, well, at the very least, disingenuous. 

Currently the Department does not have a comprehensive regulation or guidance governing our proceedings for conducting the 

rulemakings that involve the regulation of workplace toxins. That 

topic has long been discussed within the Department, within the 

Federal Government and among public stakeholders. Specifically, 

the Clinton era bipartisan presidential and congressional Commission on Risk Assessment and Risk Management thoroughly studied 

Federal risk assessment and management policies. In its 1997 final 

report, that bipartisan commission on risk made specific findings 

with respect to the Occupational Safety and Health Administration. 

In particular, it found—and I quote—OSHA seems to have relied 

upon a case-by-case approach for performing risk assessment and 

risk characterization. The commission further recommended that 

the Agency publish and describe its scientific and policy defaults 

with regard to risk assessment and risk characterization in support 

of risk management. 

Finally, let me say the Department’s proposal was developed 

with a full participation of numerous career professionals within 

several Agencies in the Department, including all experts with 

knowledge on this topic. The Department believes it is critical that 

the process for regulating workplace exposure to toxins is fully 

transparent and accountable to the public, and that is what this 

proposal seeks to do. 

Thank you again for the opportunity to testify today. I would be 

happy to answer questions from you. 

[The statement of Mr. Sequeira follows:]

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Chairwoman WOOLSEY. Thank you. 

Dr. Monforton. 

STATEMENT OF DR. CELESTE MONFORTON, PH.D., MPH, 

GEORGE WASHINGTON UNIVERSITY SCHOOL OF PUBLIC 

HEALTH 

Ms. MONFORTON. Chairwoman Woolsey, Ranking Member Wilson, and other members of the subcommittee, I am Celeste 

Monforton and a researcher at the George Washington University 

School of Public Health, and I appreciate the opportunity to be here 

today and ask that my full statement be made a part of the record. 


seq-7.eps
15

On its face, I understand how some individuals might ask, who 

could be against the Labor Department having requirements for 

risk assessment, or others might wonder why a large group of 

health scientists and the American Public Health Association urge 

the Secretary to withdraw this proposal. 

Here is the problem: Our Nation’s system for protecting workers 

from harmful substances that causes injury and illnesses is paralyzed. Thousands of workers are exposed every day to chemical 

compounds and physical hazards that are known to be harmful, yet 

these exposures are permitted by outdated and nonexistent OSHA 

and MSHA standards. 

As the former chairman of this subcommittee, the late Congressman Norwood, acknowledged, there are many occupational health 

standards that need to be updated in order to achieve safe and 

healthful workplaces. The public health and worker rights communities would have welcomed a Department of Labor effort to improve the efficiency and effectiveness of the rulemaking process. 

The OSH Act and Mine Act are robust, well-crafted statutes that 

give broad authority to the Secretary to regulate workers’ exposure 

to toxic materials, and both were clearly grounded in the public 

health principle of prevention. The overarching goal of both statutes was to identify, mitigate, and/or control hazards before they 

cause harm. But instead of being motivated by prevention, the 

Labor Department is sponsoring changes that will make it more 

difficult to issue health protective rules, and the longer workers are 

exposed to harmful levels of toxic materials, the greater the risk of 

harm. 

In the simplest terms, conducting a risk assessment means using 

the best information available to describe or estimate the risk of an 

adverse event. A risk assessment is a decision making tool that allows users to make informed decisions. In the context of occupational health standards, a risk assessment is prepared by OSHA to 

determine if exposure to a toxic material poses a significant risk to 

workers. If the hazard does not pose a significant risk, the Agency 

does not have the authority to regulate it. 

Since the 1980s, when the Labor Department began preparing 

quantitative risk assessments, the Agency’s products have consistently withstood vigorous scientific and public scrutiny and legal 

challenges. No matter the contaminant, asbestos, vinyl chloride, 

lead, diesel particulate, the assessments were based on the best 

available evidence determined with little room for doubt that the 

levels of exposure experienced by workers place them at a significant risk of material impairment of health or functional capacity. 

Furthermore, these risk assessments are not the only factors 

used in OSHA and MSHA regulatory decisions. The Agencies must 

also conduct analyses to determine if a proposed regulation is economically and technologically feasible. This means that even if the 

Agency’s risk assessment for chemical x suggests that an exposure 

limit should be set at y in order to protect workers’ health, the 

Agency is required to set the exposure limit at a level that is feasible. This means that a final exposure limit might be set at y 

times two or y times five, even when the risk assessment suggested 

a much lower level was warranted. 

16

In my written statement, I outline a number of problems with 

the Department’s proposed rule, including its misreading of the 

1997 commission report, the way it says it values public input but 

fails to allow adequate time for it, and its incomplete appraisal of 

key documents that already exist in the Department for standard 

setting and risk assessment. In my remaining time, however, I 

would like to draw your attention to the pitfalls of preparing a proposed rule on risk assessment in haste and without the benefit of 

experienced career Federal employees in the Department. 

Just last year a panel of scientists for the National Academies 

offered a harsh critique of a comparable effort by OMB, and the 

NAS made specific recommendations for administrative Agencies 

for the content of and procedures for developing risk assessment 

guidelines. The Labor Department ignores the NAS report in numerous respects, including the recommendation that any proposed 

guidance draw on expertise and Federal Agencies and be subjected 

to peer review. 

Curiously, the Department indicates that, quote, it does not have 

comprehensive regulations or formal internal guidance outlining 

consistent risk assessment procedures, end quote. Yet in 2002 it 

issued a special appendix under its information quality guidelines 

which specifically describe the procedures to be used by OSHA and 

MSHA when conducting risk analyses for health and safety rules. 

The Labor Department’s proposal is a sloppy piece of work that 

will impede, not improve health protections for workers. It is imperative that this committee use its oversight role to ensure that 

the promise of the OSH Act and the Mine Act are upheld for the 

sake of our Nation’s working people. These are the men and women 

who create the wealth for our businesses and for our entire economy. 

Thank you. 

[The statement of Ms. Monforton follows:]

Prepared Statement of Celeste Monforton, MPH, DrPH, Researcher, Department of Environmental and Occupational Health, George Washington 

University School of Public Health & Health Services 

Chairwoman Woolsey and Members of the Subcommittee: I am Celeste Monforton, 

a researcher in the Department of Environmental and Occupational Health at the 

George Washington University School of Public Health & Health Services. I appreciate the opportunity to appear before the subcommittee to share my views on the 

Department of Labor’s proposed rule on MSHA and OSHA risk assessment procedures for occupational health hazards.1

On its face, I understand how some individuals might ask ‘‘who could be against 

the Labor Department having requirements for risk assessment?’’ In fact, this proposal is so potentially damaging to worker health that 80 epidemiologists, physicians, and other health scientists,2 including the American Public Health Association,3 urged the Secretary of Labor to withdraw her plan to issue a regulation on 

how occupational health risks are assessed. 

I am currently preparing my detailed written comments on the proposed rule, 

which I plan to submit to the Labor Department by the September 29 deadline, but 

I am pleased to share my big-picture concerns about it, concerns that are shared 

by other public health scientists and proponents of health-protective standards for 

working men and women in our country. 

Our nation’s system for protecting workers from harmful substances that cause 

injuries, illnesses, and deaths is paralyzed. Thousands of workers are exposed every 

day to chemical compounds and physical hazards that are known to be harmful, yet 

these exposures are permitted by outdated or non-existent OSHA and MSHA standards. Hazards such as respirable coal mine dust and crystalline silica, diesel particulate, and noise,4 to name just a few, have damaged the health of generations of 

17

workers and continue to do harm today—even though we have known about these 

problems for decades. 

The Department of Labor’s record over the last 20 years is dismal with respect 

to issuing health standards to protect workers from these age-old contaminants, and 

it is particularly appalling for emerging health hazards. The overwhelming majority 

of the permissible exposure limits currently on OSHA’s and MSHA’s books date 

back to 1968 and 1973, respectively. These current limits are based on science from 

the 1960’s, meaning the last 4050 years of scientific understanding of how chemicals 

affect human health are not reflected in most OSHA or MSHA standards.5 For 

many of these compounds, the health science data suggests that the existing permissible exposure limits should be amended if we want to reduce workers’ risk of adverse health effects. As the former chair of this subcommittee, the late Congressman 

Charlie Norwood, acknowledged, there are many OSHA standards that are out of 

date and need to be updated in order to achieve safe and healthful workplaces for 

American workers.6 It should be a grave concern to all of us, no matter what our 

political views, that the promise of the OSH Act and the Mine Act is not being 

upheld for workers who are made ill due to harmful on-the-job exposures. 

While we know of many as-yet-unregulated workplace hazards, there are likely 

many others that we will become aware of in the future. There are 82,000 chemicals 

listed in U.S. EPA’s TSCA inventory,7,8 of which nearly 3,000 are compounds manufactured or imported annually in quantities greater than 1 million pounds, and another 6,000 compounds used in quantities between 10,000 and just below 1 million 

pounds.9 Many of these chemical compounds, especially in their final form, have improved our way of life. We must also recognize, however, that under current workplace standards, we have no systematic way to monitor the exposure of workers who 

manufacturer or work downstream with these thousands of compounds, nor do we 

have a mechanism to assess the adverse health consequences that may be associated with exposure to them individually or in combination with other chemicals. 

The public health and workers’ rights communities would have welcomed a Department of Labor effort to improve the efficiency and effectiveness of the rulemaking process, or even to address one of the many hazards that continue to put 

workers’ lives and health at risk. Instead, the Labor Department is sponsoring 

changes that will further paralyze the rulemaking process. Future OSHA and 

MSHA administrators who may be more inclined to pursue new standards to protect 

workers from harmful exposures will find themselves facing new obstacles. These 

obstacles mean additional months and years of exposure for workers, during which 

some of them will develop life-threatening conditions. 

Standard-Setting under MSHA and OSHA: Prevention-Based Statutes 

The Mine Act of 1977 10 and the OSH Act of 1970 11 are robust, well-crafted statutes that give broad authority to the Secretary of Labor to regulate workers’ exposure to toxic materials, and were clearly grounded in the public health principle of 

prevention. The overarching goal of both statutes was to identify, mitigate, and/or 

control hazards before they cause harm. Both statutes include the following prevention framework: 

‘‘The Secretary, in promulgating standards dealing with toxic materials * * * 

shall set the standard * * * that no employee will suffer material impairment of 

health * * * even if the employee has regular exposure to the hazard * * * for the 

period of his working lifetime.’’ 12

It might be worthwhile to explain how risk assessment informs the Department 

of Labor’s standard-setting process, but first let’s simply review what ‘‘risk assessment’’ is. The term ‘‘risk assessment’’ has a variety of meanings depending on the 

context of the ‘‘risk’’ and the perspective of the assessor. Risk assessments are conducted by investors in the financial markets, by fire chiefs in command centers during emergency response, and by environmental scientists trying to estimate the impact of a commercial development on the habitat of a native species. They may rely 

on quantitative data, qualitative data, or both.13 In the simplest terms, a risk assessment is the process of using the best information available to describe or estimate the risk of an adverse event. A risk assessment is a decisionmaking tool that 

allows users to make informed decisions; it does not dictate what the final decision 

will be. 

In the context of occupational health standards, a risk assessment is prepared by 

OSHA to determine if exposure to a toxic material poses a significant risk to workers.14 If the hazard does not pose a significant risk, the agency does not have the 

authority to regulate it. OSHA is required to make a significant-risk finding which, 

based on the U.S. Supreme Court’s 1980 suggestion,15 is a risk of about 1 in 1,000. 

This means that when there is evidence that a particular substance is causing harm 

to workers, OSHA will gather the best available information to estimate if workers 

18

exposed to the substance face a higher risk of harm compared to individuals who 

are not exposed. If, for example, the epidemiological evidence suggests that for every 

1,000 exposed workers, at least 6 excess cases of bladder cancer will occur, this information provides OSHA with its finding of ‘‘significant risk.’’ On the other hand, 

if the available evidence suggests that the number of excess cases of bladder cancer 

is 1 out of 5,000 workers, then this estimate would not meet the threshold finding 

of a significant risk. For OSHA, the written output of using the available evidence 

to characterize the exposed workers’ risk is the agency’s ‘‘risk assessment.’’

Since the 1980’s, when the Labor Department began preparing quantitative risk 

assessments to support health standards for toxic substances, the agency’s assessments have consistently withstood vigorously scientific scrutiny and legal challenges. Whether the contaminant regulated was asbestos, lead, vinyl chloride, formaldehyde, butadiene, or diesel particulate matter, the assessments have been based 

on the best available evidence and determined, with little room for doubt, that the 

levels of exposure experienced by workers placed them at significant risk of ‘‘material impairment of health or functional capacity.’’ 16

We must remember that risk assessments are not the only factors in regulatory 

decisions; OSHA and MSHA must also conduct economic analyses and ensure that 

their regulations are economically and technologically feasible. This means that 

even if the agency’s risk assessment for chemical X suggests that an exposure limit 

should be set at Y in order to protect workers from disease (e.g., lung cancer, lead 

poisoning,) the agency has to set the exposure limit as a level that is feasible. This 

might mean an exposure limit of Y*2, Y*5, or whatever level is determined feasible. 

The permissible exposure limits incorporated into OSHA standards are driven by a 

combination of the risk assessments and the feasibility data. 

If the Department of Labor is spending its finite resources on this risk assessment 

proposal it ought to be in response to a critical flaw in the current risk assessment 

process. No evidence is presented in the preamble to this proposed rule (or elsewhere, to my knowledge) to suggest fundamental flaws in OSHA’s or MSHA’s risk 

assessment practices. 

DOL’s Rationale Based on Misreading of 1997 Commission Report 

The rationale DOL gives for this proposed rule, both in the document itself and 

in statements made by Department officials, is largely based on a misreading of a 

recommendation made more than 11 years ago in a report by a Presidential/Congressional Commission.17 The Department has cherry-picked a single sentence from 

the Commission’s report and ignores its key recommendation. The part of the 1997 

Commission report DOL seizes on says that: 

‘‘OSHA seems to have relied upon a case-by-case approach for performing risk assessment and risk characterization in support of risk management policy decisions.’’

This phrase ‘‘case-by-case approach,’’ is conveniently described by the Labor Department as a ‘‘criticism,’’ 18 although the 1997 report never labels it that way. What 

DOL fails to mention in its proposal is the specific recommendation from the Commission’s report, which states: 

‘‘OSHA should publish, after appropriate public involvement and review, one or 

more sets of guidelines that lay out its scientific and policy defaults. At a minimum, 

the guidelines should cover an explicit rationale for choosing the defaults and an 

explicit standard for how and when to modify them; methods for assessing risk for 

noncancer health effects of concern in occupational settings; methods for quantifying 

and expressing uncertainty and individual variability in risk; and a statement of the 

magnitude of individual risk that it considers negligible for the various adverse 

health effects. The guidelines should help OSHA decide how extensive a risk assessment is needed in different situations. Finally, OSHA should explain and justify its 

actions when it evaluates or regulates a substance differently than other federal 

agencies that regulate the same substance.’’ 19

Note that the Commission’s recommendation was for OSHA to develop guidelines, 

not some other office within DOL that does not have experts in epidemiology, biostatistics or other health sciences, or experience preparing risk assessments on 

workplace chemical hazard exposure and health effects. An appropriate question for 

this committee to explore is determining the extent of involvement, if any, of the 

career federal employees at MSHA and OSHA in the development of this proposal. 

These individuals are the most expert at preparing occupational health risk assessments and would be best able to identify the agencies’ best practices.20

Other substantive parts of the 1997 Commission’s recommendation are curiously 

absent from DOL’s proposal, such as the suggestions to: 

• do more to address non-cancer health effects (e.g., cardiovascular, 

cardiopulmonary, neurological, reproductive) 

19

• do more to address individual variability (e.g., protection factors for susceptible 

subpopulations) 

• develop guidelines with sufficient flexibility to allow for different types of risk 

assessments depending on the nature of the hazard 

If the DOL had truly paid attention to the Commission’s recommendations rather 

than focusing on a single sentence and misinterpreting that sentence as a criticism, 

its risk-assessment proposal would have looked very different. 

DOL’s Disregard for 2007 National Academies’ Report 

Even more troubling than misreading the 1997 Commission’s report is the Department’s disregard for the much more recent 2007 report the National Research Council of the National Academies entitled ‘‘Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget.’’ This report offered 

a harsh critique of the White House Office of Management and Budget’s proposed 

risk assessment guidelines, including the conclusion that OMB’s product was ‘‘fundamentally flawed.’’ 21,22 In the NRC’s report, the scientific committee recommended 

to OMB that any risk assessment guidance documents prepared by the Administration: ‘‘outline goals and general principles of risk assessment designed to enhance 

the quality, efficiency, and consistency of risk assessment * * * [that would] be consistent with each agency’s legislative mandates and missions, and draw on the expertise that exists in federal agencies and other organizations. The technical guidance developed by or identified by the agencies should be peer-reviewed and contain 

procedures for ensuing agency compliance with the guidance.’’ 23

The Department of Labor has failed to fulfill this recommendation by neglecting 

to: 

• ‘‘outline goals and general principles of risk assessment’’; 

• develop guidelines that would ‘‘enhance the quality, efficiency and consistency 

of risk assessment’’; 

• ‘‘draw on the expertise in federal agencies and other organizations’’; and 

• subject the proposed rule to ‘‘peer review’’

I would respectfully request Chairwoman Woolsey or other members of the subcommittee to ascertain from Assistant Secretary Sequeira why this proposed rule on 

risk assessment does not meet the standards recommended just last year by the National Academies’ panel. 

‘‘Best Practices’’: Missing in Action in DOL’s Proposed Rule 

There is a fundamental disconnect between what the Department of Labor says 

about this proposed rule and their actions. 

1) Their timing discourages the input they claim to value 

First, the proposed rule says they are seeking public comment ‘‘* * * in order to 

gain valuable public input and in the interests of full transparency and accountability.’’ 24

Yet, the time allowed to submit written comments is only 30 days (the deadline 

is September 29), hardly consistent with the Department’s claim of wanting to receive ‘‘valuable public input.’’ Similarly, Secretary Chao’s spokesperson said the public would ‘‘have plenty of opportunity’’ 25 to examine and debate the proposal. It is 

hard to believe he actually thought that a robust debate could occur in such a short 

time span. 

2) They made a feeble attempt to compile OSHA’s actual best practices 

The preamble to the proposed rule suggests that the regulation is simply about 

assembling the Department’s ‘‘best practices’’ for risk assessment into a single document. OSHA has nearly 30 years of history developing risk assessments, and had 

the Department truly wanted to compile the agency’s ‘‘best practices’’ it could have 

evaluated methodically the scientific assumptions, controversies, and other issues 

encountered by OSHA and MSHA over the years. In DOL’s proposed rule, however, 

one will find very little in the regulatory text that could be characterized as a ‘‘best 

practices.’’ Instead the proposal offers the most elementary definitions of ‘‘hazard 

identification,’’ ‘‘dose-response assessment,’’ and ‘‘exposure assessment,’’ and completely neglects to mention the Department’s own five-page appendix issued in 2002 

under its Information Quality Guidelines describing procedures to be used by OSHA 

and MSHA when conducting risk analyses for health and safety rules.26 Likewise, 

the news release issued by the Department stated ‘‘the department does not have 

comprehensive regulations or formal internal guidance outlining consistent risk assessment procedures,’’ 27 again, forgetting about its written procedures already on 

the books. 

20

3) They describe the ANPRM as a best practice when it is not 

While overlooking practices developed by OSHA and MSHA experts over the past 

several decades, the Department’s proposal identifies one practice that it identifies 

erroneously as a ‘‘best practice’’: Advanced notice of proposed rulemaking (ANPRM). 

The Department offers no evidence to support its assertion that ANPRM represents 

a best practice for risk assessment. To the contrary, I would suggest that that available data indicates that adding the mandatory step of an ANPRM delays significantly the completion of a standard to protect workers’ health. In the case of 

OSHA’s rule on butadiene, the agency issued an 

ANPRM in 1986 and the final rule was not completed until 1996. For methylene 

chloride, OSHA published an ANPRM in 1986 and the final rule was issued in 1997. 

In contrast, OSHA’s did not issue an ANPRM for hexavalent chromium, it proposed 

a rule in 2004 and the final was issued in 2006. Likewise, MSHA proposed its diesel 

particulate matter rule in 1998 and completed it in January 2001. I suppose a ‘‘best 

practice’’ is in the eyes of the beholder. If the objective is to delay health protective 

rules as long as possible, an ANPRM would be a ‘‘best practice.’’ But for the workers 

who are exposed to a hazardous substance and whose health would be protected by 

a workplace standard, the extra years of delay associated with an ANPRM are anything but a best practice. There are costs associated with such delays, costs in terms 

of additional years of exposure and harm incurred. 

4) They fail to follow their own proposed rule for posting documents promptly 

In its proposed rule, DOL is requiring MSHA and OSHA to post all relevant documents at Regulations.gov within 14 days of each key steps in the rulemaking process (e.g., issuing a proposed rule). As of September 15, 2008 (17 days after DOL’s 

proposed rule was published in the Federal Register—and more than halfway 

through the comment period) the Department has not yet posted any supporting 

documents or background materials in the public docket for this rule.28 The double 

standard is striking. 

The Department of Labor’s entire process for developing and issuing the proposal 

has disregarded recent reports and decades of MSHA and OSHA practices, while ignoring the standards of openness and transparency that the Department claims to 

value. Most distressing, however, is the content of the rule. The Department of 

Labor is proposing changes to MSHA’s and OSHA’s risk assessment procedures that 

will impede, not improve, health protections for workers. It is imperative that this 

Committee use its oversight role to ensure that the promises of the OSH Act and 

the Mine Act are upheld for the sake of our nation’s workers—the individuals who 

create the wealth for businesses and our entire country. 

REFERENCES

1 U.S. Department of Labor, Assistant Secretary for Policy. ‘‘Requirements for DOL Agencies’ 

Assessment of Occupational Health Risks,’’ (RIN: 1290-AA23), 73 Federal Register 50909, August 29, 2008. 2Letter from scientists to Secretary of Labor Elaine Chao, August 14, 2008, (Attachment A) 

3Letter from Georges Benjamin, MD, Executive Director, American Public Health Association, 

to Secretary of Labor Elaine Chao, August 12, 2008 (Atachment B) 4The gaps in worker protections for well known hazards are glaring. Neither OSHA nor 

MSHA have comprehensive occupational health standards to protect workers from respirable 

coal mine dust or respirable crystalline silica. In 1974 NIOSH recommended an exposure limit 

for silica of 0.05 mg/m3 (for up to a 10-hr workday during a 40-hr workweek) [National Institute 

for Occupational Safety and Health, U.S. Department of Health, Education and Welfare. ‘‘Criteria for a recommended standard: occupational exposure to crystalline silica,’’ 1974] and reiterated this recommendation in 2002 [National Institute for Occupational Safety and Health, U.S. 

Department of Health and Human Services, ‘‘NIOSH Hazard Review: Health Effects of Occupational Exposure to Respirable Crystalline Silica,’’ 2002.] In 1995, NIOSH recommended that coal 

miners’ exposure to respirable coal mine dust be reduced from 2 mg/m3 to 1 mg/m3 (timeweighted concentration for up to 10 hours/day) [National Institute for Occupational Safety and 

Health, U.S. Department of Health and Human Services, ‘‘Criteria for a recommended standard: 

occupational exposure to respirable coal mine dust,’’ 1995] yet the outdated standard remains 

on MSHA’s books. A comprehensive OSHA standard to protect many workers from noise-induced 

hearing loss was issued in 1983, but there is no equal health protection for construction workers. In January 2001, MSHA issued a health standard to protect underground mine workers 

from exposure to diesel particulate matter (which is associated with cardiovascular and 

cardiopulmonary disease, and lung cancer,) but workers in all other industries (e.g., industrial 

operations, construction sites, bus/truck depots and repair platforms, shipyards and ports, etc.) 

are not protected adequately from this hazardous exposure. 5Occupational Safety and Health Administration, U.S. Department of Labor. Air contaminants proposed rule. 53 Federal Register 20960, June 7, 1988; 30 Code of Federal Regulations, 

Subpart D: Air quality and physical agents, 56.5001. 6The Honorable Charlie Norwood, Opening Statements at hearings of the Subcommittee on 

Workforce Protections: ‘‘Making Sense of OSHA Rulemaking: A Thirty Year Perspective,’’ June 

21

14, 2001; ‘‘The Role of Consensus Standard Setting Organizations,’’ November 1, 2001; ‘‘Can a 

Consensus be Reached to Update OSHA’s PELs,’’ July 16, 2002. 7 A list maintained by EPA based on submissions from manufacturers which provides information on chemicals in commerce, called the TSCA inventory, referring to the Toxic Substances 

Control Act of 1976 which authorized EPA to collect this information. 8 U.S. General Accountability Office. ‘‘Chemical Regulation: Comparison of U.S. and Recently 

Enacted European Union Approaches to Protect against the Risks of Toxic Chemicals,’’ Report 

No. GAO-07-825, August 2007. 9Lowell Center for Sustainable Production, University of Massachusetts, Lowell. ‘‘The Promise and Limits of the United States Toxic Substances Control Act,’’ October 2003. Available at: 

www.chemicalspolicy.org/downloads/Chemicals—Policy—TSCA.doc 10 29 U.S.C. §651 11 30 U.S.C. §801, et seq 12 Section 6(b)(5) of the Occupational Safety and Health Act of 1970 

(29 U.S.C. §651), and Section 101(a)(6)(A) of the Federal Mine Safety and Health Act of 1977 

(30 U.S.C. §801, et seq). 13 In 1983, the National Research Council issued the legendary ‘‘Red Book,’’ which defined 

[chemical] risk assessment as ‘‘the qualitative or quantitative characterization of the potential 

health effects of particular substances on individuals or populations.’’ National Research Council. Risk Assessment in the Federal Government: Managing the Process. 1983. 14 Under the U.S. Supreme Court’s decision in Industrial Union Department v. American Petroleum Institute, [448 U.S. 607 (1980)], OSHA is required to find ‘‘as a threshold matter, that 

the toxic substance in question poses a significant health risk in the workplace and that a new, 

lower standard is therefore ’reasonably necessary or appropriate’ to provide safe or healthful employment and places of employment.’’ 15 Industrial Union Department v. American Petroleum Institute, 448 U.S. 607 (1980). 16Section 6(b)(5) of OSH Act. 17The Presidential/Congressional Commission on Risk Assessment and Risk Management. 

‘‘Risk Assessment and Risk Management in Regulatory Decision-Making.’’ Final Report, Vol. 2, 

1997. 18OSHA News Release. ‘‘Notice of Proposed Rulemaking on U.S. Department of Labor’s risk 

assessment procedures published in Federal Register,’’ Release Number: 08-1242-NAT, 08/29/

2008. 19The Presidential/Congressional Commission on Risk Assessment and Risk Management. 

‘‘Risk Assessment and Risk Management in Regulatory Decision-Making.’’ Final Report, Vol. 2, 

1997. (p. 133-134) 20The proposal also fails to mention the comprehensive report prepared by the National Advisory Committee on Occupational Safety and Health which was commissioned precisely to examine and make recommendations on OSHA’s standards development process. The report was released on June 6, 2000. 21 National Research Council of the National Academies. ‘‘Scientific Review of the Proposed 

Risk Assessment Bulletin from the Office of Management and Budget,’’ 2007. 22 National Academies. News Release: ‘‘Report Recommends Withdrawal of OMB Risk Assessment Bulletin,’’ January 11, 2007. 23The Presidential/Congressional Commission on Risk Assessment and Risk Management. 

‘‘Risk Assessment and Risk Management in Regulatory Decision-Making.’’ Final Report, Vol. 2, 

1997. (p. 105) 24 U.S. Department of Labor, Assistant Secretary for Policy. ‘‘Requirements for DOL Agencies’ 

Assessment of Occupational Health Risks,’’ (RIN: 1290-AA23), 73 Federal Register 50909, August 29, 2008, at 50910. 25Lewis R. Bush Administration Tries To Slow Workplace Toxin Rules. ProPublica, July 23, 

2008. At: http://www.propublica.org/article/bush-administration-tries-to-slow-workplacetoxinrules-723/ 26 U.S. Department of Labor. ‘‘Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by the Department of Labor,’’ October 

1, 2002. 27OSHA News Release, Release Number 08-1242-NAT, 08/29/2008. 28 Public docket available 

at http://www.regulations.gov 

ATTACHMENT A

August 14, 2008. 

Hon. ELAINE CHAO, Secretary of Labor, 

U.S. Department of Labor, Suite S-2018, 200 Constitution Avenue N.W.,

Washington, DC. 

DEAR SECRETARY CHAO: We are writing to urge you to withdraw the proposed rule 

‘‘Requirements for DOL Agencies’ Assessment of Occupational Health Risks’’ (RIN 

1290-AA23), which is pending review at the Office of Management and Budget’s 

(OMB) Office of Information and Regulatory Affairs. The proposed rule fails to provide any validated guidance that would improve the current risk assessment approaches used by MSHA and OSHA, and has serious flaws that would weaken current procedures and undermine occupational health rules. Furthermore, the draft 

22

1Original documents and chronology of events can be accessed at: http://

www.defendingscience.org/case—studies/Secret-DOL-Rule.cfm. 2The National Research Council (NRC) Report, Scientific review of the proposed risk assessment bulletin from the Office of Management and Budget (2007), pointed out that, ‘‘the major 

recommendations that have emerged from nearly 25 years of study of risk assessment have 

much in common’’, including the following: the Red Book (NRC, 1983); Science and Judgment 

in Risk Assessment (NRC, 1994); Understanding Risk: Informing Decisions in a Democratic Society (NRC, 1996), and Review of the Proposed OMB Risk Assessment Bulletin (NRC, 2007). 3 NRC. Scientific review of the proposed risk assessment bulletin from the Office of Management and Budget. National Research Council, 2007. http://www8.nationalacademies.org/

onpinews/newsitem.aspx?RecordID=11811. 4Monforton, C. Secret rule on OSHA risk assessment? The Pump Handle. July 8, 2008. http:/

/thepumphandle.wordpress.com/2008/07/08/secret-rule-on-osha-risk-assessment/. 5Leonnig, CD. U.S. rushes to change workplace toxin rules. Washington Post. July 23, 2008; 

Page A01. 6Monforton, C. Congress demands briefing on Chao’s mystery proposal for risk assessment. 

July 10, 2008. http://thepumphandle.wordpress.com/2008/07/10/congress-demands-briefingon-chaosmystery-proposal-for-risk-assessment/. 7 NRC. Science and Judgment in Risk Assessment. 1994. p. 217. 

8OSH Act of 1970, Section 6(b)(5); Mine Act of 1977, Section 101(a)(6)(A). 

proposal would add an additional step to the rulemaking process, further delaying 

the development and issuance of needed health and safety protections for workers.1

If the Department of Labor (DOL) is serious about improving its risk assessment 

approaches, it should be guided by recommendations of the National Academies’ National Research Council (NRC) and other authoritative bodies, rather than a scattered approach that fails to incorporate advice from agency experts, practitioners, 

worker advocates, and the public.2 The NRC panel charged with reviewing the 2006 

OMB Risk Assessment guidelines issued its scathing report in January 2007, concluding ‘‘that the OMB bulletin is fundamentally flawed’’ and recommending that 

‘‘it be withdrawn.’’ 3 Nonetheless, many of the faulty OMB recommendations have 

re-emerged in this DOL proposal. 

Moreover, it is ironic that your proposal will require MSHA and OSHA to issue 

an Advance Notice of Proposed Rulemaking (ANPRM) soliciting public input, but 

you failed to follow this same mandate with respect to this proposal. It was developed without any opportunity for early public input.4 In fact, the secrecy of this proposal resulted in a front-page story in the Washington Post5 and a request from 

Senator Edward Kennedy (D-MA) and Congressman George Miller (D-CA) to be 

briefed by DOL about its proposal.6

We discuss three major flaws with the document: 1) altering the definition of a 

working life from 45 years to an average number of years, 2) calling for uncertainty 

analysis without providing any guidance that would actually improve the quality, 

reliability, or utility of such an analysis, and 3) taking regulatory action only where 

clinical adverse health outcomes have been demonstrated. 

1) Altering the definition of a working life 

The proposed rule seeks to reduce the definition of a working life from as many 

as 45 years to an average number of years, justifying this move with data tables 

showing that most workers stay with the same employer for much less time than 

45 years. While workers do change jobs, they are much less likely to change into 

a job that significantly reduces their risks. Individuals who learn a skilled trade like 

welding, for example, may indeed change employers over their careers, but most 

practice their welding trade for their entire working lives. Furthermore, an expert 

panel of the National Academies issued a report in 1994 that recommended against 

this unvalidated and unrealistic approach in their discussion of ambient exposures 

to the general public over a lifetime, notwithstanding the data that show multiple 

changes of residences over a lifetime.7

The attempt to weaken the definition of a working life is contrary to the healthprotective frameworks mandated in the Occupational Safety and Health Act of 1970 

and the Federal Mine Safety and Health Act of 1978, which specifically direct the 

Department of Labor to issue standards on toxic agents that assure workers’ health 

is protected even if an employee ‘‘has regular exposure to the hazard * * * for the 

period of his working life.’’ 8 Congress wanted OSHA and MSHA to set standards 

that would protect people who choose to work in the same industry for 45 years. 

2) Calling for uncertainty analysis without providing any guidance that would actually improve the quality, reliability, or utility of such an analysis 

The proposal calls for a rigorous uncertainty analysis, but provides no clear guidance on how to conduct one. The NRC report criticizes this same failure in the OMB 

Risk Assessment Bulletin, saying, 

23

‘‘In the absence of clear guidance regarding the conduct of uncertainty analysis, 

there is a serious danger that agencies will produce ranges of meaningless and confusing risk estimates, which could result in risk assessments of reduced rather than 

enhanced quality and objectivity.’’

Because risk assessors must rely on imperfect and incomplete data, decisions are 

informed by various guidance documents that are publicly available and publicly 

documented, and have been publicly vetted. Reliance on guidance documents helps 

to ensure that evaluations are consistent across substances and as objective as possible. This proposal fails to provide any useful guidance for important questions 

such as what default assumptions agencies will use, how agencies will decide when 

available data is robust enough to move away from default assumptions, and how 

incomplete exposure data should be used to support dose-response estimates. 

3) Taking regulatory action only where clinical adverse health outcomes have been 

demonstrated 

Finally, the draft regulatory text suggests the Department seeks to reserve its 

regulatory action for hazards associated solely with clinically apparent adverse 

health outcomes, by saying that, ‘‘The dose-response step determines a quantitative 

model that accounts for the relationship between a hazard and an adverse health 

outcome’’ (emphasis added). OMB in its Risk Assessment Bulletin was admonished 

for failing to specifically define the term ‘‘adverse.’’ The NRC (2007) panel wrote: 

‘‘The bulletin’s definition of adverse effect implies a clinically apparent effect, 

which ignores a fundamental public-health goal to control exposures well before the 

occurrence of any possible functional impairment of an organism. Dividing effects 

into ’adverse and ’nonadverse’ ignores the scientific reality that adverse effects may 

be manifest along a continuum.’’3 (emphasis in original) 

By oversimplifying the risk assessment process, demanding an unachievable 

quantification of uncertainty, and defining adverse effects in a narrow manner that 

overlooks medical reality, the Department has created a proposed regulation that 

will hamper the OSHA and MSHA in their Congressionally-mandated duties to protect workers’ health from toxic agents. 

In conclusion, this proposed rule will significantly weaken current risk assessment 

approaches without offering any improvements and will undermine worker health 

protections. 

There are scores of workplace health and safety hazards for which the regulation 

needs to be updated, and hundreds more that have not yet been regulated. The Department of Labor should turn its attention and direct resources to such hazards 

as silica, diacetyl and beryllium—not to a deeply flawed rule that will make future 

efforts to safeguard the health of U.S. workers more difficult. 

As industrial hygienists, physicians, epidemiologists, toxicologists, and other practitioners involved in workers’ safety and health research and prevention programs, 

we urge you to withdraw this proposed rule. 

Sincerely,

[Affiliations for identification purposes only, and do not constitute an endorsement on the part 

of the institution of information contained in this letter.]

Celeste Monforton, MPH, DrPH (corresponding author) Lecturer and Researcher, 

Dept of Environmental & Occupational Health School of Public Health & 

Health Services The George Washington University 2100 M Street NW, Suite 

203, Washington, DC 20037 Phone: 202-994-0774 Email: celeste.monforton@gwumc.edu

Jennifer Sass, PhD (corresponding author) Senior scientist, Health and Environment Natural Resources Defense Council 1200 New York Avenue, NW, Suite 

400 Washington, DC 20005 Phone: 202-289-2362 Email: jsass@nrdc.org

Robin Baker, MPH, Director, Labor Occupational Health Program Center for Occupational and Environmental Health School of Public Health University of California, Berkeley

Les Boden, PhD, Professor, Department of Environmental Health Boston University 

School of Public Health

Kathleen Burns, PhD, Director, Sciencecorps Lexington, Massachusetts

Barry Castleman, ScD, Environmental Consultant Garrett Park, Maryland

Richard Clapp, DSc, Professor, Department of Environmental Health Boston University School of Public Health, and Adjunct Professor, Department of Work Environment University of Massachusetts Lowell

James Cone, MD, MPH, Occupational Medicine New York City

24

Carl F. Cranor, PhD, Professor of Philosophy Department of Philosophy University 

of California Riverside

Mark R. Cullen MD, Yale School of Medicine

James G. Dahlgren, MD, Assistant Clinical Professor of Medicine, and Specialist in 

Occupational and Environmental Toxicology University of California Los Angeles

Linda Delp, PhD, Director, Labor Occupational Safety & Health Program University 

of California Los Angeles

John M. Dement, PhD, CIH, Professor, Division of Occupational & Environmental 

Medicine Department of Community & Family Medicine Duke University Medical Center

David Egilman MD, MPH, Clinical Associate Professor Brown University

Bradley Evanoff, MD, MPH, Associate Professor of Medicine Washington University 

School of Medicine

Adam M. Finkel, ScD, CIH, Professor of Environmental and Occupational Health, 

UMDNJ School of Public Health Fellow and Executive Director, Penn Program 

on Regulation, Univ. of Pennsylvania Law School

Arthur L. Frank MD, PhD, Drexel University School of Public Health

John R. Froines, PhD, Center for Occupational and Environmental Health University of California Los Angeles

Scott Fruin, DEnv, Assistant Professor, Department of Preventive Medicine, USC 

Keck School of Medicine

Ken Geiser, PhD, Co-Director, Lowell Center for Sustainable Production, University 

of Massachusetts Lowell

Fred Gerr, MD, Professor, Director, Occupational Medicine Residency Program The 

University of Iowa

Lynn Goldman, MD, MPH, Professor, Bloomberg School of Public Health Johns Hopkins University

David F. Goldsmith, MSPH, PhD, Associate Research Professor Department of Environmental & Occupational Health School of Public Health & Health Services 

George Washington University

Tee L. Guidotti, MD, MPH, Director Division of Occupational Medicine and Toxicology The George Washington University Medical Center

Robert Harrison, MD, MPH, Professor of Medicine Division of Occupational and Environmental Medicine University of California, San Francisco

Michael R. Harbut, MD, MPH, FCCP, Co-Director, National Center for Vermiculite 

and Asbestos-Related Cancers Karmanos Cancer Institute, Wayne State University, and Chief, Center for Occupational and Environmental Medicine Royal 

Oak, Michigan

Robin Herbert, MD, Director, World Trade Center Medical Monitoring and Treatment Program, Data and Coordination Center Associate Professor of Community and Preventive Medicine Mount Sinai School of Medicine

Peter F. Infante, DrPH, Professorial Lecturer, Department of Environmental and 

Occupational Health School of Public Health and Health Services The George 

Washington University

Anne Katten, MPH, Pesticide and Work Safety Project Director California Rural 

Legal Assistance Foundation

David Kriebel, ScD, Professor, Department of Work Environment School of Health 

and Environment University of Massachusetts Lowell

Joseph LaDou, MS, MD, Division of Occupational and Environmental Medicine University of California School of Medicine

Philip J. Landrigan, MD, MSc, Professor and Chairman, Department of Community 

& Preventive Medicine Professor of Pediatrics, Director, Children’s Environmental Health Center

Paul Landsbergis, PhD, MPH, Associate Professor, Department of Environmental 

and Occupational Health Sciences Graduate Program in Public Health State 

University of New York-Downstate Medical Center Mount Sinai School of Medicine

Richard A. Lemen, PhD, MSPH, Assistant Surgeon General, USPHS (ret.) Rear Admiral, USPHS (ret.)

25

Charles Levenstein, PhD, MSOH, Professor Emeritus of Work Environment University of Massachusetts Lowell

Stephen M. Levin, MD, Medical Co-Director

I.J. Selikoff Center for Occupational & Environmental Medicine Mount Sinai School 

of Medicine

Bruce Lippy, PhD, CIH, CSP, The Lippy Group, LLC Baltimore, Maryland

Gerald Markowitz, PhD, John Jay College City University of New York

Steven Markowitz, MD, City University of New York

Michael McCann, PhD, CIH, Director of Safety Research CPWR—The Center for 

Construction Research and Training

Ron Melnick, PhD, National Institute of Environmental Health Sciences

David Michaels, PhD, MPH, Professor and Interim Chair Department of Environmental & Occupational Health School of Public Health & Health Services The 

George Washington University

Franklin E. Mirer, PhD, CIH, Professor, Environmental and Occupational Health 

Sciences Urban Public Health Program Hunter College School of Health 

Sciences

Jacqueline Moline, MD, MSc, Vice Chair, Community and Preventive Medicine Director, WTC Medical Monitoring and Treatment Program, Clinical Center at 

Mount Sinai Director, NY/NJ Education and Research Center Mount Sinai 

School of Medicine

Kathleen Morris, MSA, RN, Director of Nursing Practice Ohio Nurses Association

Tim Morse, PhD, CPE, Associate Professor Occupational and Environmental Health 

Center University of Connecticut Health Center

Roni Neff, PhD, MS, Research Associate Johns Hopkins Bloomberg School of Public 

Health

Mark Nicas, PhD, MPH, CIH, Adjunct Professor, Environmental Health Sciences 

Division School of Public Health University of California Berkeley

L. Christine Oliver, MD, MPH, MS, Assistant Clinical Professor of Medicine, Harvard Medical School, and Associate Physician Massachusetts General Hospital

Peter Orris, MD, MPH, Professor and Chief of Service Environmental and Occupational Medicine University of Illinois at Chicago Medical Center

David Ozonoff, MD, MPH, Professor of Environmental Health Chair Emeritus, Department of Environmental Health Boston University School of Public Health

Glenn Paulson, PhD, Professor of Environmental and Occupational Health and Associate Dean for Research UMDNJ-School of Public Health

Lew Pepper, MD, MPH, Assistant Professor Boston University School of Public 

Health

John M. Peters, MD, Hastings Professor of Preventive Medicine Division of Environmental Health USC School of Medicine

Gerald Poje, PhD, Former Board Member US Chemical Safety and Hazard Investigation Board

Laura Punnett, ScD, Professor, Department of Work Environment Director, Center 

to Promote Health in the New England Workplace (CPH-NEW) Senior Associate, Center for Women and Work (CWW) University of Massachusetts Lowell

Margaret M. Quinn, ScD, CIH, Professor, Department of Work Environment School 

of Health and Environment University of Massachusetts Lowell

Patty Quinlan, MPH, CIH, Industrial Hygienist UCSF Occupational and Environmental Medicine Program

Julia Quint, PhD, Retired Research Scientist, California Department of Public 

Health Member of the Board of Directors, Worksafe, Inc. Berkeley, California

Kathleen Rest, PhD, MPA, Executive Director Union of Concerned Scientists

Carol Rice, PhD, CIH, Professor Department of Environmental Health University of 

Cincinnati College of Medicine

Knut Ringen, DrPH, MHA, MPH, Principal, Stoneturn Consultants Seattle, Washington

Thomas G. Robins, MD, MPH, Professor of Occupational and Environmental Medicine Director, Center for Occupational Health and Safety Engineering Director, 

Fogarty International Center Southern African Program in Environmental and 

Occupational Health University of Michigan School of Public Health

26

Beth Rosenberg, ScD, MPH, Assistant Professor Department of Public Health & 

Family Medicine Tufts University School of Medicine

Kenneth Rosenman, M.D., FACPM, FACE, Professor of Medicine Chief, Division of 

Occupational and Environmental Medicine Michigan State University

Frank S. Rosenthal, PhD, Associate Professor of Occupational and Environmental 

Health Sciences Purdue University School of Health Sciences

David Rosner, PhD, Ronald H. Lauterstein Professor of Sociomedical Sciences and 

History Columbia University

Rachel Rubin, MD, MPH, Medical Director, MacNeal Occupational Health Services, 

and Assistant Professor University of Illinois Chicago School of Public Health

Steven Samuels, PhD, Associate Adjunct Professor, Retired University of California, 

Davis

Ellen K. Silbergeld, PhD, Professor, Environmental Health Sciences Johns Hopkins 

University Bloomberg School of Public Health

Darius D. Sivin, PhD, International Representative Legislative, Governmental and 

International Affairs United Automobile, Aerospace and Agricultural Implement 

Workers of America (UAW)

Leslie Thomas Stayner, PhD, Professor and Director Division of Epidemiology and 

Biostatistics University of Illinois Chicago School of Public Health

Steven D. Stellman, PhD MPH, Professor of Clinical Epidemiology Mailman School 

of Public Health Columbia University

Kyle Steenland, PhD, Professor Department of Environmental and Occupational 

Health Emory University

Glenn Talaska, PhD, CIH, Professor of Environmental Health The University of 

Cincinnati College of Medicine, and Vice Chair, ACGIH BEI Committee

Daniel Thau Teitelbaum, MD, Adjunct Professor Occupational and Environmental 

Medicine School of Public Health University of Colorado, Denver, Adjunct Professor, Environmental Sciences The Colorado School of Mines

Joel A. Tickner, ScD, Assistant Professor Lowell Center for Sustainable Production 

University of Massachusetts Lowell

Nicholas Warren, ScD, MAT, Associate Professor of Medicine/Ergonomics Coordinator Division of Public Health and Population Science University of Connecticut Health Center

David H. Wegman, MD, MSc, Dean School of Health and Environment University 

of Massachusetts Lowell

Laura S Welch, MD, Medical Director CPWR—The Center for Construction Research and Training 

ATTACHMENT B

August 12, 2008. 

Hon. ELAINE CHAO, Secretary of Labor, 

U.S. Department of Labor, Suite S-2018, 200 Constitution Avenue N.W.,

Washington, DC. 

DEAR SECRETARY CHAO: On behalf of the American Public Health Association 

(APHA), the nation’s oldest and most diverse organization of public health professionals in the world, I write to express our opposition to Department of Labor’s 

(DOL) proposed regulation that would significantly alter the preventive health 

framework embodied in the Occupational Safety and Health Act of 1970 (OSH Act) 

and the Mine Safety and Health Act of 1978 (Mine Act). The proposed ‘‘Requirements for DOL Agencies’ Assessment of Occupational Health Risks,’’ which is pending review at the White House’s Office of Management and Budget, is contrary to 

the most fundamental public health principle of prevention. 

Occupational diseases can best be prevented by reducing exposure levels of workers to toxic agents and processes. The DOL proposed rule seeks to alter the definition of a working life to an arbitrary average number of years—a notion and that 

is wholly inconsistent with public health and risk science standards. The document 

also makes erroneous characterizations of uncertainty, risk, and adverse health effects, in direct opposition to recommendations made by the National Academies of 

Science (NAS) in their 2007 report. 

The DOL draft proposal also would require that the Occupational Safety and 

Health Administration (OSHA) and the Mine Safety and Health Administration 

(MSHA) issue an Advanced Notice of Proposed Rulemaking for all health-based 

standards. This new mandatory step in the process will further delay protective 

27

rules, even those with well-understood adverse health effects, such as respirable 

coal mine dust and silica. Although the DOL is charged with worker health and 

safety protection, it has only issued one health standard over the last 10 years. The 

latest DOL proposal would only add steps to the rulemaking process, and thus delay 

health protections for workers even further. 

APHA urges you to withdraw this proposed rule immediately.

GEORGES C. BENJAMIN, MD, FACP, FACEP (Emeritus), 

Executive Director. 

Chairwoman WOOLSEY. Thank you. 

Mr. Johnson. 

STATEMENT OF RANDEL JOHNSON, VICE PRESIDENT, LABOR, 

IMMIGRATION, EMPLOYEE BENEFITS, U.S. CHAMBER OF 

COMMERCE 

Mr. JOHNSON. Thank you, Madam Chairwoman. Let me try to 

put this a little bit in context. Before I joined the committee, where 

I did work for 10 years, I also worked handling many OSHA regulations at the Department of Labor——

Chairwoman WOOLSEY. Mr. Johnson, a little closer. 

Mr. JOHNSON. Let’s turn the tape back there so I can get my 

time back. 

Before joining the committee, where I did work for 10 years, 

Madam Chairwoman, I did spend some time at OSHA working on 

many rulemakings, including benzene, formaldehyde, nonasbestisform tremolite, the Personal Exposure Limit project, which 

was a personal disappointment where we did regulate 438 chemicals in a very swift rulemaking over seven months. Unfortunately, 

the court struck that down. I think we could have done that, however, if we had taken four or five more months and done it properly. But I have had some experience in this area, although I 

meant to be a generalist. 

But this rulemaking needs to be put in the context of, look, this 

is an Advanced Notice of Proposed Rulemaking. There is going to 

be ample time for the public and other experts to comment on this. 

It will then become a Notice of Proposed Rulemaking before it becomes a final rule. I use the rule loosely here, because I know the 

Agency is not formally calling this a rule. An administrative procedure act, but it’s an agency action. And I still believe it would be 

challengeable in court in one way or another, although the DOL solicitor’s office may disagree with me on that. But there is a check 

and balance built into this. 

Secondly, there is nothing secret about this going on. It is an Advanced Notice of Proposed Rulemaking. What could be more open? 

Third, I think it is important to note that the courts recognize 

that much deference must be given to OSHA once it determines 

what a significant risk is. And I can quote from the court cases. 

You can look at the benzene decision and other cases. The point is, 

this is not a math—the courts do not hold OSHA to a mathematical 

straitjacket. Once OSHA makes a decision as to risk or hazard, the 

courts will defer to that absent as long as it is supported by substantial evidence. 

So it is important to get that initial risk assessment right the 

first time out. An Advanced Notice of Proposed Rulemaking allows 

the experts and OSHA to sort through the weeds and the long 

28

grass before it gets to an NPRM. And what can be wrong with 

that? 

And let me come back to the question of notice; the 30-day comment period, Madam Chairwoman, which you hit on. Frankly 30 

days is a short period of time. However, there are certainly many 

times in the history of OSHA where it has used that kind of a time 

period for even more significant regulations. 

For example, I am holding up here the proposed regulation on 

ergonomics, which was issued November 23, 1999, Thanksgiving 

week, in which we had 60 days to comment on it with 800 pages 

of regulations which is right here as comparative to this regulation, 

which is about 6 pages. Now we did ask the Clinton administration 

for a 30-day extension, which we got after selling our first born, but 

that was a massive piece of rulemaking stretching over many, 

many issues, many pages. This is six or seven pages. So maybe 30 

days is not enough. Maybe the Department will give another 30 

days. I am not sure. The point is it can be done. People can focus 

on it, and it is just an Advanced Notice of Proposed Rulemaking. 

Lastly, I think you know if a final rule comes out and it is not 

to the satisfaction of this committee, Congress always has oversight 

powers to reign in an Agency that has gone too far, and who knows 

what will happen in the next election. But I think the proper role 

for the committee might be to look at this when it comes out as 

a final rule rather than to be interfering with the Agency process 

now, which of course the Administrative Procedure Act and OSHA 

rulemaking process contemplated that the Agency would apply its 

expertise—that is why it is created—before Congress steps in. 

So you know with regard to transparency, posting things on the 

Internet, duh, I mean of course those kinds of things can be done. 

I can say in the past, such as ergonomics, the Agency failed to do 

several of those things, which is why we certainly support this regulation. Key studies were left out. We had to send law clerks over 

to the Department of Labor. I believe Senator Enzi had to go over 

there and go through the rulemaking record and find the studies 

we needed. Posting it on the Internet, what could be wrong with 

that? It certainly should be done at the same time that the NPRM 

is posted and not two weeks into that. And I think I will just—

these are—there will be lots of time to sort through these issues. 

I think it is a rulemaking that needs to be done. 

The process of a risk assessment down at OSHA is confusing. I 

met—I know less about MSHA, but this is just to try to pull it together in one useful document for the public to look at. Is it a tempest in a teapot? I am not sure. It is more important than that. But 

I think it is something that has perhaps been blown out of proportion. But nonetheless, I appreciate the opportunity to testify. And 

hopefully we will all comment seriously on this proposal if it becomes a final rule. 

Thank you, Madam Chairwoman. 

[The statement of Mr. Johnson follows:]

Prepared Statement of Randel K. Johnson, Vice President of Labor, 

Immigration and Employee Benefits, U.S. Chamber of Commerce 

Madame Chairwoman, members of the committee, I am Randy Johnson, Vice 

President for Labor, Immigration and Employee Benefits at the U.S. Chamber of 

Commerce. Before coming to the Chamber, I was the Labor Policy Coordinator and 

29

Counsel for this committee when it was chaired by Representative Goodling from 

Pennsylvania. Prior to working for this committee, I was at the Department of 

Labor working in the Solicitor’s Office on regulatory matters, including OSHA regulations such as benzene, formaldehyde, the Hazard Communication Standard, asbestos/non-asbestisform tremolite and the Personal Exposure Limit (PEL) project rulemaking. It was one of my personal disappointments that the PEL rulemaking was 

struck down by the courts. Based on my experience, what the Department of Labor 

has proposed for comment appears useful to all parties interested in OSHA and 

MSHA rulemakings, and is consistent with the principles of sound rulemakings as 

expressed during this and previous administrations. 

An agency of the federal government shall only have the power to impose a requirement on a private citizen through a regulation, either an individual, or in the 

case of OSHA and MSHA an employer, where it has made a compelling and public 

case for the need for the regulation, and demonstrating that the best available 

science and data support such a regulation. While taken for granted in Washington, 

DC, the power to regulate is an awesome one, and often underappreciated by decision makers who rarely have to live under these regulations. Inherent in these principles is that the public shall have the opportunity to examine and critically review 

the materials supporting the agency’s intended action. OSHA’s and MSHA’s rulemaking processes as well as the broader Administrative Procedure Act are built on 

this foundation. The Department of Labor is proposing to ensure that, to the greatest degree possible, these principles of best data underlying a regulation and maximum transparency are achieved, and the U.S. Chamber unequivocally supports this 

proposal. 

As a preliminary matter, I wish to emphasize what should be obvious in all regulations, but often goes unnoticed—which is that the burdens and costs of this proposal (along with its benefits) should be viewed in the context of the numerous and 

complex regulations businesses must already comply with. Currently, there are 

more than 100,000 regulations on the books with an estimated cost of over $1.11 

trillion to the public. Thousands of pages of fine print of the Code of Federal Regulations, which are then interpreted by agency directives, and ultimately by the courts 

against the backdrop of numerous statutes, truly present a huge compliance burden 

to business which is daunting to any employer. State and local laws add to the confusion. Even the best intentioned employer and even those well staffed by lawyers 

can make good faith compliance errors which agencies and plaintiffs’ lawyers will 

make much ado over, to say the least. OSHA regulations are but one small part of 

this gigantic puzzle and all the more reason they should be carefully justified before 

issuance. 

To the extent that a risk assessment by OSHA or MSHA is not adequately supported by scientific data and results in a new regulation that imposes more burdens 

on employers without producing a commensurate improvement in worker protection, 

employers will be further disadvantaged and have that many fewer resources for 

creating new jobs and compensating employees. Indeed, much will be expended on 

attorney fees to determine, in good faith, if there even was an error, given the 

vagueness of many legal requirements. 

Unfortunately, one of the major problems of government and its enforcement 

agencies is that its initiatives tend to be read in isolation and silos, rather than 

against this backdrop of the huge existing panoply of regulations. Who among us 

envies the small business person faced with these challenges? Who among us even 

dare open such a business and putting our assets on the line? We ask that you keep 

this entire picture in mind as you consider whether to support the Department of 

Labor’s proposal to implement a consistent and transparent risk assessment process. 

That being said, what constitutes the level of risk necessary for regulating by 

OSHA or MSHA is still an issue of debate. The Supreme Court in the ‘‘Benzene’’ 

decision in 1980 ruled that OSHA must establish that a significant health risk is 

presented, and that this risk can be lessened or eliminated through some change 

that can be imposed through regulation.1 While the Supreme Court established the 

requirement for finding significant risk, it did not spell out how OSHA was to do 

so. The Court mused that a one in a billion chance of someone dying from cancer 

because of drinking chlorinated water would not be significant, but a one in a thousand risk of dying from inhalation of benzene would be significant. Although it may 

be tempting to mandate such a specific statistical threshold as identifying significant risk, the Chamber believes this would be unwise. The essence of risk assessment is flexibility, as risks need to be evaluated in context. The National Research 

Council’s report on OMB’s Proposed Bulletin on Risk Assessment in criticizing 

OMB’s proposal stated that ‘‘risk assessment is not a monolithic process or a single 

method. Different technical issues arise in the probability of exposure to a given 

30

dose of a chemical. * * * Thus, one size does not fit all, nor can one set of technical 

guidance make sense for the heterogeneous risk assessments undertaken by federal 

agencies.’’ 2

A sound risk assessment is necessary for a good regulation, but getting a poorly 

supported risk assessment overturned in court is extremely difficult. Courts almost 

always defer to agencies with respect to their determinations, and in particular to 

OSHA risk assessments. This heightens the need for OSHA and MSHA to ensure 

that the science and data underpinning a regulation is adequate. 

The principles for good risk assessments have been expressed by a variety of 

sources over several administrations. Among them, the Presidential/Congressional 

Commission on Risk Assessment and Risk Management, created under the Clean 

Air Act Amendments of 1990, concluded that OSHA has ‘‘relied upon a case-by-case 

approach for performing risk assessment and risk characterization.’’ 3 The Department of Labor’s proposal seeks to systematize this process, moving beyond the ‘‘caseby-case’’ approach cited by the Commission. 

Another source for the principles of risk assessment is the Memorandum for 

Heads of Executive Departments and Agencies issued by OMB and the Office of 

Science and Technology Policy last September. The Department’s proposal reflects 

the principles stated in that memo closely. The top principle is that agencies ‘‘should 

employ the best reasonably obtainable scientific information to assess risks to 

health, safety and the environment,’’ 4 which is the central thrust of the Department 

of Labor’s proposal. The memo also makes clear that assumptions and uncertainties 

should be stated explicitly. This is also one of the provisions of the Department of 

Labor’s proposed risk assessment regulation. 

Furthermore, the proposal reflects the recommendations of the National Research 

Council in its review of OMB’s proposed risk assessment bulletin. The NRC concluded that agencies ‘‘describe, develop, and coordinate their own technical risk assessment guidance,’’ 5 instead of OMB trying to institute a generic risk assessment 

process. The NRC stated that ‘‘longestablished concepts and practices that have defined risk assessment as a process * * * involve hazard identification, hazard characterization or dose-response assessment, exposure assessment and risk characterization.’’ 6 These terms are the exact requirements for a risk assessment in the proposed regulation under section 2.9(c)(4). 

The proposal is also consistent with the Administration’s and Department of Labor’s guidelines on Information Quality, all of which stress the use of the best available data at the time of the rulemaking. Among the areas where the best available 

data is to be used is how long an employee stays at a specific job. While the Department has retreated from the position taken in the draft proposal that was leaked, 

which explicitly moved away from the assumption that workers stay at their jobs 

for 45 years, the published proposal still makes clear that OSHA and MSHA are 

to use best available scientific data including industry-by-industry evidence describing working life exposures. Relying on a stale, inaccurate assumption when better, 

more current data is available simply makes no sense. 

The proposed regulation also codifies the 1980 ‘‘benzene’’ decision by the Supreme 

Court, which established the principle that OSHA must find a ‘‘significant risk’’ that 

can be lessened or eliminated by a change in practices before promulgating any 

health standard. As mentioned above, the Supreme Court did not define ‘‘significant 

risk,’’ leaving that up to OSHA. In this proposed regulation, DOL is establishing a 

consistent process by which OSHA and MSHA will describe how significant risk was 

determined for any given health standard. 

Not only is this proposal well reasoned, necessary, and overdue, but the Department should be commended for its approach to implementing it. As this is only an 

internal policy guideline, it could have been implemented without seeking public 

comment through a notice of proposed rulemaking as they have done. If the Department had pursued that approach, the title of today’s hearing might have been appropriate—this could have been seen as a ‘‘secret’’ rulemaking. As they have chosen 

to do this through a fully public procedure, soliciting comments and input as with 

any other regulation, calling this a secret regulation is unwarranted and suggests 

a desperate intent to find something wrong with the proposal. 

What the Department has proposed is very simple—provide more information to 

the public and those interested in a specific health standard rulemaking, make sure 

that any assumptions and uncertainties are identified and explained, and give interested parties the opportunity to review and comment on the science and data upon 

which the agency is relying. These goals would be achieved through the use of mandatory Advanced Notice of Proposed Rulemakings (ANPRMs), except in the case of 

an emergency temporary standard.7 Requiring ANPRMs and thus opening up 

OSHA’s and MSHA’s scientific and data support to public scrutiny is similar to the 

way that OSHA must disclose its support for a regulation during the Small BusiVerDate 0ct 09 2002 17:35 Nov 17, 2008 Jkt 000000 PO 00000 Frm 00034 Fmt 6633 Sfmt 6621 G:\DOCS\110TH\WP\110-110\43628.TXT HBUD1 PsN: DICK
31

ness Regulatory Enforcement Fairness Act (SBREFA) review panels that are required if a regulation is determined to have a significant economic impact on a substantial number of small entities. The SBREFA process has been criticized by organized labor as giving small businesses too much access to the rulemaking process. 

By requiring that OSHA and MSHA issue ANPRMs for health standards (not safety 

standards), the Department is giving the unions and all others not part of the 

SBREFA review process the same opportunity to review the science and data upon 

which the agencies are relying and comment on these materials at a time before 

the regulation has been drafted and all but formed. Commenting at that point in 

the process is essential, since once a regulation is drafted and proposed, getting 

OSHA or MSHA to significantly revise a regulation or withdraw it because of inadequate scientific support is all but impossible. 

The Department is also requiring that all relevant documents related to the rulemaking be posted in an easily accessed and well organized format at 

www.regulations.gov—the federal government’s central internet rulemaking portal. 

This sounds so fundamental in this era of instant electronic access to an enormous 

array of authorities and data that specifying this would seem redundant or unnecessary. However, there are examples where OSHA did not make key materials available in a timely manner during major rulemakings. The most egregious of these was 

during the ergonomics rulemaking when key studies were not made available for 

review during the comment process, frustrating those who were trying to develop 

statements and questions in preparation for the administrative hearings held by 

OSHA. 

The proposed regulation from the Department of Labor specifying how risk assessments for health standards are to be done and providing greater transparency and 

opportunity for public input is absolutely consistent with the principles of risk assessments, sound rulemaking, and above all, good government. The risk assessment 

drives the entire process of regulation from the go/no go decision to what level of 

protection and remedial action may be required. It is imperative the risk assessment 

be done using the best available and most current data. The Department’s proposal 

establishes a process that will yield sound and credible risk assessments. I look forward to responding to your questions. 

ENDNOTES

1 Industrial Union Department v. American Petroleum Institute, 448 U.S. 642 (1980). 

2 2007 NAS Report on the Proposed Risk Assessment Bulletin, Executive Summary, page 7. 

3Presidential/Congressional Commission on Risk Assessment and Risk Management, Framework for Environmental Health Risk Management, 2 Final Report 133 (1997). 4OMB/OSTP Memorandum for the Heads of Executive Departments and Agencies, Updated 

Principles for Risk Analysis (2007) M—07—24. 5 2007 NAS Report on the Proposed Risk Assessment Bulletin, Executive Summary, page 7. 

6 Id. at 3. 

7 Criteria and procedures for emergency temporary standards are found under section 6(c) of 

the OSH Act, and section 101 (b)(1) of the Mine Act. 

Chairwoman WOOLSEY. Thank you. I think you heard the bells 

ring. We are going to have three votes. So Ms. Seminario, if you 

will complete and then we are going to try to have a series of questions up here because we really have 20 minutes. We know that. 

It says 13 but we know how it works. The first vote. So let’s complete the witnesses and then we will ask some questions. 

Mr. WILSON. The chairman runs very fast. 

STATEMENT OF MARGARET SEMINARIO, DIRECTOR, DEPARTMENT OF OCCUPATIONAL HEALTH AND SAFETY, AFL–CIO 

Ms. SEMINARIO. Thank you very much. My name is Peg 

Seminario. I am Safety and Health Director for the AFL-CIO, and 

I appreciate the opportunity to testify today. I have been doing this 

work for over 30 years and have worked on virtually every major 

rule that has come through the Occupational Safety and Health 

Administration. 

On August 29, just before Labor Day, the Department of Labor 

published a proposed rule in the Federal Register imposing new reVerDate 0ct 09 2002 17:35 Nov 17, 2008 Jkt 000000 PO 00000 Frm 00035 Fmt 6633 Sfmt 6602 G:\DOCS\110TH\WP\110-110\43628.TXT HBUD1 PsN: DICK
32

quirements on OSHA and MSHA for conducting occupational risk 

assessments in developing health rules. It is our view that it is actually a proposed rule, unlike what Mr. Johnson said. He thinks it 

is an Advanced Notice of Proposed Rulemaking, which indeed are 

different. So getting some clarification on that would be helpful. 

This new rule was developed in secret without any consultation 

by political appointees in the Office of Assistant Secretary of Policy 

during the last months of the Bush administration. In our view, it 

would significantly delay and potentially weaken future occupational health protections. We are greatly concerned, seeing this rule 

being pushed through by an administration that unfortunately for 

the past 71⁄2 years has refused and has failed to set any new OSHA 

health rules to protect workers. Now the administration is rushing 

to lock in place requirements to make it more difficult for the next 

administration to act to protect workers from known health risks. 

In our view, the Department of Labor risk assessment rule is unnecessary and unsound. According to the Department, the purpose 

of the rule is to compile its existing best practices related to risk 

assessment into a single easy-to-reference regulation. But as noted 

above and explained in greater detail in my written testimony, the 

rule does more than codify existing practices. It changes existing 

practices and does impose new burdens on both OSHA and MSHA. 

We believe that the rule is unnecessary. As Dr. Monforton pointed 

out, OSHA has conducted risk assessments for years and those risk 

assessments have been very robust and have withstood court challenges and have been found to have been sound. 

We also believe that the rule is inappropriate. The Department 

already has risk assessment guidelines that were adopted in 2002. 

But guidance is meant to be just that, guidance, which is nonmandatory, a flexible directive that can be changed. Indeed, when 

you look across the government, everything that has been done on 

risk assessment, including those directives out of OMB, are done 

as guidance. This is different. It is codifying these procedures in 

the Federal Register and, with that, the administration’s attempt 

to impose its policies on the next administration. We don’t see that 

in the next four months this administration is going to issue any 

new rules. They haven’t done so to date. So what is the purpose 

of this rather than putting in place its views, its policies on the 

next administration? 

We think that the rule would add years of delay to both OSHA 

and MSHA rulemakings. And with it, it will put workers at risk. 

It adds a new step, the Advanced Notice of Proposed Rulemaking, 

to the rulemaking process. Indeed, in some cases OSHA has used 

ANPRs but they use other procedures for gathering information as 

well. They have advisory committees. They have requests for information. They may conduct public meetings. This proposal would 

lock in this one particular procedure rather than leaving it to the 

discretion and judgment of the Agencies as to how to proceed. And 

it changes the rulemaking procedures that are set forth in the Occupational Safety and Health Act, in the Mine Safety and Health 

Act, and essentially it attempts to amend those rules. So we don’t 

think this one method should be imposed in a one size fits all when 

rules differ and the mechanisms for gathering information and 

what is appropriate should be flexible. 

33

It is important to point out or worth pointing out because of such 

delays that ANPRs bring to rulemaking, and we estimate it will be 

about two years of additional time. In 1987 the Administrative 

Conference suggested and recommended that OSHA not use 

ANPRs. 

It is important to point out this delay has real impact on workers. The proposal doesn’t apply only to future rules. It applies to 

those in process as well. We have three important health rules 

moving along at OSHA. One on silica, one on beryllium, another 

on diacetyl. None of those have had an ANPR. Not one of them. 

They have had other ways of gathering the information. This rule 

requires that OSHA go back to square one and start all over. You 

know, silica has been under development for 10 years, beryllium 

the same. And this will result in dozens and dozens of unnecessary 

deaths. 

So in conclusion, let me just say that this proposal is flawed. It 

is unnecessary. It is unsound, and it will harm the health of workers in this country. It should be withdrawn by the Department of 

Labor. And if it is not, we would highly support efforts by the Congress to stop it. 

Thank you. 

[The statement of Ms. Seminario follows:]

Prepared Statement of Peg Seminario, Director of Safety and Health,

AFL–CIO 

Chairwoman Woolsey, Ranking Member Wilson, and members of the committee: 

Thank you for the opportunity to testify today on the Department of Labor’s proposed rule on occupational risk assessment. My name is Peg Seminario, and I am 

Safety and Health Director for the AFL-CIO. In my more than 30 years working 

on safety and health issues, I have been involved in dozens of rulemakings on safety 

and health standards and regulations promulgated under the Occupational Safety 

and Health Act. 

On Friday, August 29, 2008, just before Labor Day, the Department of Labor 

(DOL) published a proposed rule in the Federal Register imposing new requirements 

on the Occupational Safety and Health Administration (OSHA) and Mine Safety and 

Health Administration (MSHA) for conducting occupational risk assessments in developing workplace health rules. This new rule, developed in secret by political appointees in the Office of the Assistant Secretary of Policy (OASP) during the last 

months of the Bush Administration, would significantly delay and potentially weaken future occupational health protections. 

This new rule is being pushed through by an Administration that for the past 

seven and one-half years has refused and failed to set any new OSHA health rules 

to protect workers, except for one rule that was issued pursuant to court order. 

Now, the Administration is rushing to lock in place requirements to make it more 

difficult for the next administration to protect workers from known health risks. 

This cynical measure is unfounded, unsound, and harmful to workers. We fully support HR 6660, legislation that would stop the adoption or implementation of this 

rule. 

The risk assessment rule proposed by DOL would do the following: 

• Add a new step to the rulemaking process for setting occupational health standards by requiring both OSHA and MSHA to issue an advanced notice of proposed 

rulemaking (ANPR) for every occupational health standard to solicit scientific studies and other information on health risks and exposures. This would add years of 

delay to an already glacial process and result in unnecessary death and disease for 

workers. 

• Require OSHA and MSHA to respond to every public comment submitted on the 

risk assessment issues, regardless of the validity or merit of the comment, before 

issuing a proposed or final rule. 

• Require the agencies to gather and analyze available industry-by-industry evidence related to working life exposures, which neither OSHA nor MSHA now do, 

which will add significant time to the rulemaking process and which could result 

in weaker protections for workers. 

34

• Codify existing Office of Management and Budget (OMB) and DOL informational quality and peer review guidelines, locking into place by rule controversial 

regulatory policies of the Bush Administration, many of which have been criticized 

or rejected by the National Academy of Sciences. 

• Require OSHA and MSHA to post all relevant documents related to an occupational health standard, including all underlying studies and analyses, on 

www.regulations.gov within 14 days after the conclusion of the relevant step in the 

rulemaking process. On this point, it is worth noting that 16 days after the DOL 

risk assessment rule was published in the Federal Register, DOL had failed to make 

any of the underlying documents related to this rulemaking part of the public docket. 

The DOL Risk Assessment Rule is Unnecessary and Unsound 

According to DOL, the purpose of this rule is ‘‘to compile its existing best practices 

related to risk assessment into a single, easy to reference regulation.’’ But as noted 

above, and explained in greater detail below, the rule does more than codify existing 

practices—it changes existing practices and imposes new burdens on OSHA and 

MSHA. 

The rule is unnecessary. OSHA has conducted risk assessments for its occupational health rules for decades, and recently MSHA has done so as well. OSHA’s 

risk assessments have withstood court challenges and have been found to be sound. 

And the rule is inappropriate. The Department of Labor already has risk assessment guidelines that were adopted in 2002 as part of DOL’s information quality 

guidelines to implement Bush Administration policies on peer review and data quality. (Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and 

Integrity of Information Disseminated by the Department of Labor, October 1, 

2002.) Guidance is meant to be just that—non-mandatory, flexible directives that reflect the views, policies and practices of an agency, department or administration, 

and that can be changed. By proposing to codify these risk assessment practices into 

a formal rule, the Bush Administration is attempting to impose its policies and 

practices on the next administration. 

The Rule Will Add Years of Delay to OSHA and MSHA Rulemaking and Delay 

Needed Protections 

The DOL rule would require OSHA and MSHA to issue an ANPR for every occupational health rule, except for emergency rules. This new mandatory step for every 

rulemaking is not needed and will delay needed protections. 

The OSHA and MSHA standard setting processes already provide for much more 

extensive public input and participation than virtually all other government agencies. Both agencies routinely cast a wide net, soliciting information using a variety 

of mechanisms such as Requests for Information published in the Federal Register, 

public meetings, stakeholder meetings, workshops, advisory committees, and negotiated rulemaking committees, in addition to publishing a formal ANPR in the Federal Register. ANPRs may be appropriate for some rules, but rules vary in their 

complexity and approach, and it is unsound to impose a one-size fits all process and 

methodology on all rules. 

Mandating an additional formal step in the rulemaking process for every occupational health rule, and requiring OSHA and MSHA to respond to all comments on 

the risk assessment issues before even issuing a proposed rule, will add approximately two years to a process that already takes eight or more years to complete. 

For this reason, in 1987 the Administrative Conference of the United States recommended that OSHA not routinely use ANPRs. ACUS Recommendation 87-10, 

Regulation by the Occupational Safety and Health Administration, 52 Fed. Reg. 

49,147 (1987). 

It is important to point out that this delay in protection has real impacts on worker health. Every month or year of delay results in unnecessary exposure by workers 

to harmful substances, and results in deaths and illnesses that could have been prevented. For example, according to OSHA’s risk assessment on hexavalent chromium, 

every year of delay in the adoption of the new 5.0 ug/m3 standard resulted in 40 

to 145 lung cancer deaths. Similarly, OSHA’s preliminary risk assessment on silica 

estimates that reducing the permissible exposure limit to 50 ug/m3 will prevent 41 

silicosis deaths and 19 lung cancer deaths annually. Every year of delay in setting 

a silica rule results in 60 unnecessary deaths. 

The proposed new risk assessment rule includes rules currently under development within its reach. This means that for rules that have been under development 

for years, OSHA will have to go back to square one and start anew under the new 

risk assessment rules. So, for example, an OSHA rule on silica that has been under 

development since 1997 will be delayed even further. It is worth noting that the siliVerDate 0ct 09 2002 17:35 Nov 17, 2008 Jkt 000000 PO 00000 Frm 00038 Fmt 6633 Sfmt 6621 G:\DOCS\110TH\WP\110-110\43628.TXT HBUD1 PsN: DICK
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ca rule has been designated by the Bush Administration as a priority for action on 

the Regulatory Agenda since 2002, and that OSHA completed the required small 

business review on the draft silica rule in 2003. But for the past 4 years the OMB 

required peer review of the silica risk assessment has been repeatedly delayed. It 

is our understanding that this rule, like other pending OSHA rules, has been held 

up by the Office of the Secretary. And now, with this new rule the Department 

would require OSHA to start all over and issue an ANPR for silica, delaying this 

important standard for many more years. 

The risk assessment rule would also delay action on an OSHA standard to protect 

workers from diacetyl, a food flavoring chemical that causes a disabling deadly lung 

disease. As you know, last year the House of Representatives passed legislation requiring OSHA to issue a final standard on diacetyl within two years of enactment. 

The Bush Administration opposed the legislation and refused to issue an emergency 

rule, but promised to move expeditiously to develop a diacetyl standard through normal rulemaking procedures. But there has been no such action. A small business 

review on a draft diacetyl rule, scheduled to be initiated in January, has yet to happen, and there is no sign that the Administration has any intention of acting. If the 

next Administration decides to move quickly on diacetyl, they can’t. The new DOL 

risk assessment rule would require OSHA to issue an ANPR and respond to all comments before moving forward with a proposed rule. 

It is shameful that after refusing to take action to protect workers from serious 

well-recognized health hazards for 7 1/2 years, that the Bush Administration is 

spending its lasts months and taxpayer money to lock in place rules that would prevent the next administration from taking prompt action. 

The DOL Rule Would Change the Way OSHA and MSHA Assess Worker Health 

Risks and Could Result in Weaker Protections 

The new DOL rule would require OSHA and MSHA to gather and analyze available industry-by-industry evidence related to working life exposures in evaluating 

risk, which neither OSHA nor MSHA now do. Changing OSHA and MSHA’s risk 

assessment practice in this manner is inappropriate and could lead to weaker protections for workers. 

The current practice of both agencies is to evaluate the risk of exposure posed to 

the overall population of workers exposed to the hazard in question at the level of 

exposure under an existing rule or conditions, and to assess how a reduction in exposure to lower levels would reduce that risk. Both the OSHAct and the MSHAct 

require that the agencies protect workers against health risks even if they are exposed over the course of a working lifetime. In keeping with this statutory requirement, both agencies have adopted a practice of assessing workplace health risks 

based upon exposure over 45 years. 

In regulating occupational health risks, both agencies usually set a single permissible exposure level for all workers exposed to the hazard. This limit applies to all 

industries covered by the rule. The agencies appropriately assume that exposure to 

similar levels of a chemical pose the same risk to workers, regardless of the sector 

where the exposures occur. Thus, the proposed industry-by-industry assessment of 

health risks—and the idea that different exposure limits could be set for workers 

in different sectors—makes no sense for rules that cover many groups of workers. 

In addition, the proposal appears to potentially open the door to changing OSHA 

and MSHA’s longstanding assumption of a 45 year working lifetime exposure. An 

earlier version of the proposal explicitly made this change, and the new proposal 

is murky on this point. Such a change would be unsound. In many industries such 

as coal mining and construction, a large number of workers are employed in the industry or the occupation over their entire working life. These long-term workers are 

at the greatest risk and deserve to be protected. Basing risk determinations and exposure levels on the average time in an occupation or industry will reduce the level 

of protection and leave all workers at greater risk. For example, if OSHA’s 

hexavalent chromium standard was based on the assumption that workers were on 

average employed for 10 years, the permissible exposure level would be 4.5 times 

higher than that set by OSHA, creating a greater risk for all workers, and allowing 

much greater cumulative exposures and risk for long-term workers. This approach 

is unsound and contrary to the directive in the Occupational Safety and Health Act 

and Mine Safety and Health Act that protections be set at a level that will protect 

workers who are exposed for a ‘‘working lifetime.’’

The Process by Which DOL Has Developed the Risk Assessment Rule is Highly Irregular and Flawed 

The proposed risk assessment rule has been developed in secret by political appointees in the Department of Labor’s Office of Assistant Secretary for Policy 

36

(OASP), with little involvement by OSHA and MSHA and with no public notice 

prior to its publication. OASP has no expertise in risk assessment and no authority 

under the Occupational Safety and Health Act or Mine Safety and Health Act for 

the development or issuance of occupational safety and health rules. It is our understanding that the background for the rule was developed by an outside contractor, 

not by the agencies or OSHA or MSHA experts on risk assessment and occupational 

health standards. 

This is in direct contradiction to the recommendation by the National Academy 

of Sciences that risk assessment guidelines be developed by the individual agencies 

with the technical expertise and knowledge of legislative requirements. (National 

Academy of Sciences, Scientific Review of the Proposed Risk Assessment Bulletin 

from the Office of Management and Budget, 2007). 

The risk assessment rule was not included in the Department of Labor’s semi-annual regulatory agenda published in April 2008, despite a requirement under Executive Order 12866 that all rules under development be listed on the agenda. The first 

public indication that this rule was even under consideration came on July 7, when 

a notice was posted on www.reginfo.gov, that the draft proposed rule was at OMB 

for review under Executive Order 12866. No explanation or information about the 

rule was posted, and the Department refused to provide any information to the Congress, the press or public when asked. Information about the content of the rule only 

became public when the Washington Post obtained an earlier draft and published 

a story on July 23. Subsequently, the Post and other media outlets obtained a copy 

of the draft that had been submitted to OMB for review, and posted the document 

on their respective websites. 

Many in the scientific, labor, and occupational safety and health communities objected to the Department of Labor’s draft proposal and the process by which it was 

developed. The American College of Occupational and Environmental Medicine, the 

American Industrial Hygiene Association, the American Public Health Association 

and a group of over 75 scientists all wrote to Secretary of Labor Elaine Chao urging 

her to withdraw the draft rule. 

Despite these objections, the Department forged ahead. The draft proposal was 

cleared by OMB on August 25th, and published in the Federal Register on August 

29, 2008, the Friday before Labor Day. 

The proposed rule violates the policy announced by White House Chief of Staff 

Josh Bolten on May 9, 2008, which states that except for ‘‘extraordinary circumstances,’’ agencies were supposed to issue any new proposed rules by no later 

than June 1, 2008. No ‘‘extraordinary circumstances’’ exist to justify DOL’s lastminute rule. 

The Department is trying to rush the proposal through and is depriving the public 

of an opportunity to meaningfully participate in this rulemaking process. DOL is 

giving the public only 30 days to comment on the proposed rule—an unusually short 

comment period that started on the Friday before a three-day holiday weekend. 

The 30 day time period for comment on a rule with such significant impact is unusual and inadequate. OSHA and MSHA typically provide a far longer comment period on their proposed rules, and Executive Order 12866, under which the proposal 

was supposedly reviewed, says that agencies should ordinarily provide at least 60 

days’ notice. 

For example, in 1996, when OSHA was adopting new rules on Recording and Reporting Occupational Injuries and Illnesses, the agency initially provided 90 days for 

comments and extended the comment period twice for a total comment period of 150 

days. In addition, six days of public meetings were held to provide full opportunity 

for public input. 

Even for non-mandatory guidance, agencies have generally provided much longer 

comment periods than 30 days. When OMB proposed its Bulletin on Peer Review 

and Information Quality in 2003, an initial 90-day comment period was provided 

and a public workshop was convened at the National Academy of Sciences. In response to comments, in 2004, a revised draft bulletin was re-proposed and an additional 30 days were provided for comments. Recently, OSHA published Proposed 

Guidance on Workplace Stockpiling of Respirators and Facemasks for Pandemic Influenza and provided 60 days for public comments. Prior to this in 2007, OSHA had 

circulated a draft for public comment and with CDC convened a series of public 

meetings soliciting input from interested stakeholders. 

Moreover, while the proposed DOL risk assessment rule requires OSHA and 

MSHA to post documents in the public docket within 14 days, as of September 15, 

2008, 16 days after the proposal was published, the Department had failed to post 

any of the background documents and analyses related to this rule. 

Finally, and importantly, because the proposed risk assessment rule will affect 

the substance and process of standard-setting under the Occupational Safety and 

37

Health Act and the Mine Safety and Health Act, it is the AFL-CIO’s view that the 

Department of Labor must hold a public hearing on the proposal if requested. The 

AFL-CIO and others have requested such a hearing, but the Department has given 

no indication that it intends to schedule one. 

Conclusion 

The Bush Administration started its tenure in 2001 by repealing OSHA’s 

ergonomics standard, and for the past 7 1/2 years it has refused to take action to 

issue new safety and health protections unless under court order or in response to 

Congressional mandates. Now in its waning days, the Administration is attempting 

to put in place new regulatory requirements that would make it much more difficult 

for the next administration to take action to protect workers. DOL’s proposed risk 

assessment rule is unsound, unnecessary and will result in unnecessary deaths and 

disease among workers. If the Department of Labor does not withdraw this harmful 

measure, we urge the Congress to enact legislation to stop it. 

Chairwoman WOOLSEY. Thank you. I am going to yield to Mr. 

Payne. 

Mr. PAYNE. Thank you very much. I will just be brief since we 

are going to have to leave. 

Let’s see. Mr. Sequeira, this proposal we are talking about has 

not been peer reviewed. Why did your office disregard the recommendation from the National Academies made in 2007 which 

states that technical guidance developed by Agencies should be 

peer reviewed? 

Mr. SEQUEIRA. The Department’s proposal is not required to be 

peer reviewed. The proposed rulemaking and what we are seeking 

comment on is not technical and is not guidance and therefore is 

not subject to peer review. 

Mr. PAYNE. Okay. Therefore, because it is not subject to peer review, therefore you discount the fact that, you know, that it 

shouldn’t be? I mean, your answer is that it is not required, therefore a lot of things weren’t required. That is why AIG had to get 

$85 billion from the government yesterday. You know, things that 

are required and not required as opposed to what should be done 

to prevent things from happening are what we are concerned 

about. And there seems to be a nonchalant sort of cavalier attitude 

by the Department of Labor that these things are not required, 

therefore, it is like water off a duck’s back. 

Mr. SEQUEIRA. Well, Congressman, as I understand it, the process of peer review applies to technical information studies, reports 

in the academic sense that articles are peer reviewed. This proposal, the Department’s proposal doesn’t represent anything of that 

kind. I am not sure what there is in the proposal to be peer reviewed, frankly. 

Mr. PAYNE. Okay. Would any of the other witnesses like to express their point of view? Yes, Doctor. 

Ms. MONFORTON. Thank you. Your question is excellent in terms 

of the requirement for peer review. Yes, it is not a requirement. 

But the Department of Labor says over and over again that this 

is something about best practices, and I don’t think there is anyone 

here that would suggest that recommendations coming out of the 

National Academies would not be considered best practices. And 

the National Academies specifically said that any risk assessment, 

guidance, document prepared by the administration should meet 

certain criteria and it should be subject to peer review. 

Mr. PAYNE. Yes. 

38

Ms. SEMINARIO. I would just support what Dr. Monforton has 

said. The Department can’t have it both ways. They can’t be proposing by rule to make law certain, they say existing best practices, 

but some changes in practices, say that on the one hand but on the 

other hand say that it shouldn’t be peer reviewed or they don’t 

need public comment on it. They also shouldn’t be saying, quite 

frankly, when they are attempting to change the way standards are 

set in the standard setting process, change the Administrative Procedures Act, change the Occupational Safety and Health Act and 

Mine Safety and Health Act requirements for how you set rules. 

Both those laws say you issue a proposal and then you issue a 

final. Both of them also provide for advisory committees. And suddenly, lo and behold, we have a whole new proposal to say we have 

a whole new formal step for every occupational health rule. You 

can’t do that and say that, no, we don’t think we should take public 

comment or no, we don’t think that peer review is needed. It just 

doesn’t make any sense. 

Mr. PAYNE. Yes. 

Mr. JOHNSON. Normally the employer can be very strong supporters of peer reviewed studies, and we would certainly join with 

the unions here on requiring peer reviewed studies generally in 

OSHA standard-setting processes which are so important here. I 

think whether or not they had to be done here, I think your point 

is perhaps they should have been done. 

I am not quite sure of the legal requirements of this proposal. It 

appears to be not the kind of methodological studies that are normally subject to a peer review process. But I am not quite sure. 

With regard to Peg Seminario’s—these changes in the rulemaking 

process, look, an ANPR is not recognized under the Administrative 

Procedures Act, that is true, or the rulemaking process under 

OSHA. However, the APA has not been amended since 1940—well, 

in this area since 1947. The OSHA act has not been amended since 

1972. Surely there is some room for some novelty and reflection in 

terms of improving the rulemaking process in those 40 years. 

The ANPRMs are commonly used by Agencies. They are not 

some strange creature, and they can be used quickly by Agency to 

clear out their underlying brush and move quickly to an ANPRM. 

What Agencies often do, unfortunately, is use ANPRMs as an excuse to get their political overseers on Capitol Hill off their back 

or the courts, and that is unfortunate but it is used by both Republican and Democratic administrations. 

If they are not used as an excuse, and they are used as good 

faith mechanisms to get to conclusions quickly and allow public 

comment, then they are very useful. But they shouldn’t be used as 

a shield, which is a problem. 

Chairwoman WOOLSEY. Thank you very much. Thank you, Mr. 

Payne. The ranking member and I will be back after the votes, and 

I will try to get the rest of our committee back up here too. All 

right. So hang on. We will be back. 

[Recess.] 

Chairwoman WOOLSEY. Thank you for waiting for us. The vote 

is still not quite over; so our Ranking Member will get here soon. 

I will take this opportunity to ask my questions. 

39

I am very concerned, Mr. Sequeira, that we are kind of missing 

the point here. In this rulemaking, we are adding a new step to 

rulemaking, which will lengthen rulemaking, and in all of the language regarding hearings and review, it refers to exceptional circumstances in order to skip the steps necessary. 

So my question, and this is after I introduced the popcorn lung 

bill regarding diacetyl, and that was just out of sheer frustration 

because of OSHA’s inaction, and it just leads me to asking you 

questions of why adding this step is more important than the three 

OSHA examples that Dr. Monforton talked about and I talked 

about in my opening statement. Why do we need this standard so 

urgently that you operated in an opaque fashion, leapt ahead of all 

other OSHA and MSHA regulations? What in your standards and 

in this process is going to save lives? 

Mr. SEQUEIRA. Madam Chair, there is nothing in the Department’s proposal here that necessarily lengthens rulemaking. And 

ANPRM, as I mentioned earlier, is not a new process. It is used 

often by OSHA already. In fact, the recent standards issued by 

OSHA began with ANPRMs. 

It is no secret that OSHA rulemakings take a long time. That is 

due to a number of factors, not the least of which are the statutory 

requirements that Congress has put on the agency. OSHA has to 

comply with no fewer than eight statutes when it conducts a rulemaking. That more than anything is responsible for the length of 

time. 

Chairwoman WOOLSEY. And this rule—and, Ms. Seminario and 

Dr. Monforton, respond to this and see if maybe I am wrong—this 

is going to add steps to the process, it is going to make it longer 

if you prevail in what you are aiming at. 

Mr. SEQUEIRA. Actually I don’t think that that has the case. An 

ANPRM can be conducted during the already statute-required 

SUBREFA process. 

Chairwoman WOOLSEY. Let me reclaim my time and turn it over 

to Ms. Seminario. 

Ms. SEMINARIO. Again, let us look at the rules that are pending 

that we are concerned about: Diacetyl scheduled for a SUBREFA 

review that was supposed to start in January; silica, a peer review 

requirement which comes from the Bush administration directive 

that they have to conduct peer review. It is not a statutory requirement, it is a Bush administration policy which this rule would now 

codify. That peer review has been pending for four years. 

SUBREFA review on silica took place in 2003. So on its face this 

rule says that OSHA has to go back now and conduct an ANPR, 

start all over, collect data, respond to all the comments, redo their 

risk assessment which is ready for peer review. So again, it does 

add a new step and particularly is problematic for those things 

which have been in the pipeline for years which are underway. And 

again, it is not appropriate to use this mechanism for every rule. 

Ms. MONFORTON. I would also like to just state again that in 

terms of best practices, I don’t see anything in the preamble to the 

rule that suggests that an ANPRM has been demonstrated to be 

a best practice. I think it would be really useful for someone to look 

at perhaps two OSHA rules where an ANPRM was issued and two 

40

OSHA rules when it wasn’t issued, and look at the real quality of 

the information that comes in from the ANPRM. 

When the agency issues an ANPRM, there is no requirement. It 

doesn’t have subpoena power to require information from companies or scientists to get information, and you are kind of at the 

mercy of whoever wants to send in information. So you could actually look at what is submitted during that process and find out 

does it really add anything to the quality of the product that ultimately comes out? 

Chairwoman WOOLSEY. Mr. Johnson. 

Mr. JOHNSON. Just, Madam Chair, I know time is limited, but 

just very quickly, ANPRM is a generalized way of gathering data 

because it asks generalized questions. It gets it in the hopper for 

people to look at it and analyze it. 

The problems with an ANPRM are traditionally it is actually a 

proposed regulation, very specific, so by definition it narrows the 

constraints of those who can comment to that regulation. And the 

range of changes between ANPRM and the final rule as a practical 

matter are very small for APA reasons. So an ANPRM is a useful 

way to collect data upfront, look at it carefully. And you are going 

to have to deal with those issues anyways. I don’t really think it 

is going to result in delays in and of itself, but an agency can use 

that excuse for a delay. It really comes down to not the process 

itself, but, I think, the desire of the agency to move forward for 

other reasons. 

Chairwoman WOOLSEY. Well, it is my understanding all of those 

questions have to come out in the final review, so why would we 

have it at the front and the back end? It does add steps to the process. 

Mr. JOHNSON. It is all going to wind up in court. You may as well 

try to deal with some upfront early on rather than later. 

Chairwoman WOOLSEY. Well, and then again later. I am sorry. 

My time is up, and I am going to yield to Mr. Wilson for the purpose of questioning the witnesses. 

Mr. WILSON. Thank you again for being here and staying over, 

too. 

Additionally, Mr. Secretary, I appreciate your explanation about 

the open process that is under way, not a secret, one that can be 

intelligible and very helpful in receiving information to truly help 

the people who are working in our country and who understand the 

significance of safety. 

In written questions which were sent to the Department by the 

Majority, you provide an answer to this question, but can you explain for the record today upon what authority the Department of 

Labor took this policy change? Furthermore, why did the Department decide to seek public comment on the proposed policy change? 

Mr. SEQUEIRA. The proposals issued under the Secretary’s general authority at 5 U.S.C. 301, this proposal is not a health standard. It is not a rulemaking. It is not issued pursuant to the Occupational Safety and Health Act or the Mine Safety and Health Act. 

It is issued pursuant to the Secretary’s general authority to prescribe Departmental procedures and process. 

As you noted, we weren’t required under the Administrative Procedure Act to seek public input or comment on this, but the DeVerDate 0ct 09 2002 17:35 Nov 17, 2008 Jkt 000000 PO 00000 Frm 00044 Fmt 6633 Sfmt 6602 G:\DOCS\110TH\WP\110-110\43628.TXT HBUD1 PsN: DICK
41

partment thought that that was important to do. So we expressly 

affirmatively made that decision to put this proposal out and seek 

public comment on it, which is ironic that some would call it secret, 

by the way. Anybody who is familiar with the Administrative Procedure Act knows that by definition a rulemaking is a public process. It is impossible to be secret. 

Mr. WILSON. And, further, I think you have explained this in letters of July 17, 2008, and September 5, 2008, to the Chairman. 

I would like to submit these for the record. 

Chairwoman WOOLSEY. Without objection. 

[The information follows:]


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Mr. WILSON. And indeed in terms of workers’ safety, I am 

pleased that for the last six out of seven years, there has been a 

reduction in the number of persons injured and killed in the workplace across America. And a person who I greatly admire is my fellow home stater Ed Foulke. So be sure to tell Secretary Foulke 

hello for me. 

Mr. SEQUEIRA. I will. And, Congressman, I would note, if I may, 

that not only are injury and illness rates declining, they are at the 

lowest level in recorded history under this administration. 

Mr. WILSON. And I appreciate this coming out, because part of 

my service, I have visited the different manufacturing facilities 

across the district, and we are really very pleased, in particular forVerDate 0ct 09 2002 17:35 Nov 17, 2008 Jkt 000000 PO 00000 Frm 00050 Fmt 6633 Sfmt 6602 G:\DOCS\110TH\WP\110-110\43628.TXT HBUD1 PsN: DICK

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eign direct investment. I have got three Michelin plants in the district I represent. We have Bridgestone Tire next door, which is Japanese. We have Westinghouse Nuclear Fuels, which is also Japanese. We have significant German, Swiss, Swedish investments in 

the district that I represent. And going by and visiting the different 

manufacturing facilities of flooring, of oriented strand board, Canadian investment, everywhere I go, obviously the very first point 

that I see is safety. 

And it is completely understanding that businesses cannot be 

successful without a healthy and safe workforce, in addition to the 

fact, obviously, that the people who work at the manufacturing facilities live, work, and play with the families of the people who are 

the managers. So over and over again I have seen a positive step. 

Mr. Johnson, in your testimony you reflect the Chamber of Commerce’s support for this regulation. How do you believe this regulation improves the regulatory process for stakeholders? 

Mr. JOHNSON. Well, I think it just brings together in one document all the different procedures that the Department of Labor can 

look at in setting risk assessment. For example, I have an article 

here on the carcinogen policy, which mentions that traditionally 

the current collection of policies and regulations is remarkable for 

the inconsistent and incomplete way in which suspect chemicals 

are treated. It is—my experience at the Department of Labor was 

that it is a very confusing decision-making process, who makes 

what decision on risk, what are they looking at. This tries to bring 

in one document for the public to understand. But more importantly, it is just very simple and requires, for example, all documents to be up on the Web and be transparent and easily accessible. It used to be companies would have to hire law clerks to go 

down to the Department of Labor, Xerox records and bring them 

back in a paper file, and this makes it all much easier and commonsense. 

Ms. SEMINARIO. I might just say that OSHA has always had a 

very robust docket, even before there was regulations.gov. They 

have had an electronic docket with information up there. It is also 

worth pointing out that this particular rule was posted on August 

29 on regs.gov, which is—I guess now is 18 days ago, and none of 

the documents related to this rule and its underpinnings had been 

posted as of this morning. So all that appears on that public docket 

is the rule and then a number of submissions of requests for extensions, but none of the underlying dockets—there was a big contractor’s report that was done. Taxpayers spent $350,000 in support of 

this, and none of that information, none of the background behind 

this rule is on the Web, and we have 12 days left to comment on 

it. 

Mr. WILSON. And I would say that we are in the age of Internet, 

which makes access so readily available worldwide. So I would 

hope and expect that whatever shortcomings you see, that you can 

bring them to the attention of good Members of Congress like 

Chairwoman Woolsey or me, and we will be happy to make inquiry. 

And I would think, again, transparency truly is beneficial. It is not 

negative. 

And I yield. 

Chairwoman WOOLSEY. Thank you. 

48

Mr. Payne, Congressman Payne. 

Mr. PAYNE. Thank you very much. 

I think that there is some dispute perhaps in certain industries, 

and the one that the Assistant Secretary is mainly familiar with, 

there has been a superb record of safety. However, I just want to 

bring out that perhaps you are not involved with the cleaning industry. For example, Cintas, which is a large industry of uniform 

cleaning and cleaning of large laundries, have had several deaths, 

two actually in my district about a year ago, unsafe conditions 

where workers were not given safety equipment to clean out these 

big vats. 

Secondly, I am not sure that anyone—and maybe the building industry is not under your jurisdiction specifically, but you had a tremendous number of deaths in the construction industry this year 

in New York City alone. I mean, you have had almost one a month 

easily, even more than that, crane safety, safety of employees. We 

have had an epidemic. So maybe in South Carolina things are 

great, but I know up in New Jersey and New York, we have had 

bad luck. Perhaps we don’t get the hurricanes, but evidently we 

have other kinds of disasters that impact on human beings. 

I might just ask a question of Mr. Johnson, where you object to 

the designation of this program as a secret regulation because DOL 

‘‘has chosen to do this thoroughly through a full public procedure, 

soliciting comments and input as with any other regulation.’’ That 

was a quote. So I just kind of find it astonishing actually that you 

claim that the Department has solicited as much input as with any 

other regulation. So I don’t know if you would perhaps bring to my 

attention any other regulations or any other regulation which will 

significantly affect OSHA or MSHA standards as this does that did 

not have a hearing or more than a 30-day period of comment. 

Mr. JOHNSON. Well, as I mentioned earlier, the ergonomics regulation, which is right here, hundreds of pages long, only had a 60-

day comment period, and that was issued during Thanksgiving 

week of 1990, and we eventually got an extension from that. I am 

not—Congressman, whether 30 days is appropriate to this as distinguished to 60, I will say we often ask for an extension on comments. And perhaps an extension from 30 days to 60 may be appropriate in this case. We asked for an extension—actually, we didn’t. 

But formaldehyde, benzene, hazard communication standards, I 

have worked on all of those, and traditionally their initial rulemaking period is quite short, and then traditionally there is an extension of comment. 

Which had hearings or which did not, frankly I would have to go 

back and take a look at that. Whether or not a hearing is appropriate in this case, I am not going to hazard a position on this and 

wouldn’t take one. 

Ms. SEMINARIO. Let me just say with respect to comment periods 

on ergonomics, the ergonomic rule was under development for 

years. There was a draft proposal with all of the background that 

was circulated to interested parties back in 1993. There were public meetings. This went on for years and years and years. So the 

notice that came out in 19 whatever—in 1999 originally was one 

that had, you know, lots of public input prior to that. 

49

This rule came out of nowhere. This rule came out of nowhere. 

It wasn’t in the regulatory agenda. We had no notice that it was 

coming. The first we saw was when—the fact that it had gone to 

OMB on July 7. 

Mr. JOHNSOn talked about when OSHA did its cancer policy. 

That was done under the Occupational Safety and Health Act. 

There were extensive hearings. I went to every day of those hearings. I think it was my first year at the AFL-CIO, three months 

of public hearings at the Department of Labor on that policy. 

Ergonomics, we had months and months, weeks of public hearings 

on that. 

So the bottom line is 30 days is basically the shortest time possible for comment. It certainly is not providing for the robust public 

comment which the Bolten memo said agencies should be following 

in the final months of the administration. 

And also we think that a hearing on this is required, given the 

way the Department is doing it. They are essentially changing 

standards and standard setting under the Occupational Safety and 

Health and Mine Safety and Health Act, and both those laws say 

when a party objects and requests a hearing, they have to be granted a hearing. We put that question, and we would expect that the 

Department would follow the law. 

Mr. JOHNSON. I believe as a technical matter that this is the Department saying, this is not our standard, this is not a regulation; 

it is an internal agency practice, therefore not technically subject 

to some of those requirements. But that is a separate—what might 

be the right thing to do, which is more public input. 

Chairwoman WOOLSEY. The gentleman’s time has expired. 

Mr. PAYNE. Just if I might mention, I do recall also those hearings on ergonomics and how I was wondering when we were ever 

going to pass anything, they had so many hearings on it. So I think 

to say, well, you have got 60 days, is kind of not—is far from the 

truth. I thought it went too long before the regulations came out. 

Thank you. 

Chairwoman WOOLSEY. Congressman Hare. 

Mr. HARE. Thank you, Madam Chairman. My apologies. I was in 

a markup on Veterans, so I didn’t get to hear the testimony. 

But I am troubled here, Mr. Sequeira, and maybe you can help 

me out. Was anyone on OSHA or MSHA consulted on this proposed 

rule? 

Mr. SEQUEIRA. Yes. 

Mr. HARE. Did they ask you to issue the rule? 

Mr. SEQUEIRA. I am sorry? 

Mr. HARE. Did the agencies ask you to issue the rule after you 

consulted with them? The reason is I am curious why the rule is 

coming out of the DOL policy office and not the health and safety 

agencies. 

Mr. SEQUEIRA. Yes. I understand that you weren’t here for the 

earlier testimony, Congressman, but as I mentioned earlier, this 

proposal is issued pursuant to the Secretary’s general authority to 

issue regulations related to the Department procedures. It is not 

issued pursuant to the Occupational Safety and Health Act or the 

Mine Act. 

50

Mr. HARE. Well, in my opinion, it seems like it is going to be 

tying the hands of any future administration, which, to be candid 

with you, I would consider shameful because of how long it currently takes OSHA and MSHA to issue standards, and the fact 

that OSHA has issued only one major standard during this administration and they were ordered to do so under court order. So I do 

have a concern about that. 

My other couple of concerns is why move forward on this proposal after 80 epidemiologists, as I understand it, physicians in the 

American Public Health Association, advised the Secretary of 

Labor to withdraw the proposal for reasons that it would be damaging to workers’ health? I mean, doesn’t that kind of fly in the 

face of what the experts are saying? Maybe you can help me try 

to understand why you folks know more than these epidemiologists, physicians in the American Public Health Association? 

Mr. SEQUEIRA. I don’t know precisely which experts you are referring to or what their specific argument is. People may have different views about the regulation. That is the purpose of a noticeand-comment period, so that we can collect those views from the 

public. 

As for delays, we discussed earlier an ANPRM and a health rulemaking does not necessarily lengthen the time it takes to do an 

OSHA rulemaking. Those rulemakings take a long time. Much of 

that time is required by Congress because of statutes Congress has 

passed, and in addition they take a long time because of the inevitable lawsuits. There have been nearly two dozen lawsuits including some filed by members on this panel against OSHA in rulemaking. 

Mr. HARE. But didn’t you bypass standard procedure for following the rule? For example, it was not announced in the most recent semiannual DOL regulatory agenda, and which is in violation 

of Executive Order 12866. You only provided 30 days for public 

comment rather than the customary 60 days that is laid out under 

the Executive Order. So there are no public hearings. You have not 

made any of the underlying documents relating to the rule part of 

the public docket. So can you explain to me why that happened? 

Mr. SEQUEIRA. My understanding is some people have requested 

a public hearing. The Department will consider those requests. 

Again, unlike the OSH Act and the Mine Act, there is no requirement for the Department to conduct a public hearing. The item was 

not listed on the spring regulatory agenda of the Department, and 

that is for a simple reason. The spring regulatory agenda lists regulations that the Department is pursuing. 

Mr. HARE. So you are comfortable with the 30 days instead of the 

60 days for comments and people being able to testify about it? 

Mr. SEQUEIRA. Congressman, we are in the middle of an open 

rulemaking and a notice-and-comment procedure, and I am not 

going to prejudge at this point what the appropriate time for comments is. The Department in its initial proposal said 30 days. As 

I understand it, we have received requests, but I am not prepared 

here today to judge requests that I haven’t even seen about whether we should extend that comment period. 

Mr. HARE. Well, I understand that, but I don’t understand why 

standard procedure proposing the rule, which is in violation of ExVerDate 0ct 09 2002 17:35 Nov 17, 2008 Jkt 000000 PO 00000 Frm 00054 Fmt 6633 Sfmt 6602 G:\DOCS\110TH\WP\110-110\43628.TXT HBUD1 PsN: DICK
51

ecutive Order 12866, and I am just wondering if you are comfortable with going against Executive Order 12866. 

Mr. SEQUEIRA. Congressman, I respectfully disagree with your 

characterization that it is not in compliance with Executive Order 

12266. 

Mr. HARE. Dr. Monforton, you mentioned in your testimony—I 

am sorry if I mispronounced your name. 

Ms. MONFORTON. No. That is correct. 

Mr. HARE. Thank you. I am getting something right here today. 

You said in your testimony that the proposed rule would be quite 

damaging to workers by further paralyzing the rulemaking process. 

I wonder if you could go into more detail on how it would do that. 

Ms. MONFORTON. I would be happy to. As numerous people have 

said here, regulating occupational health hazards takes a long 

time. There are numerous steps in the process, including numerous 

steps that have been instituted by this administration and under 

the previous Congress under SUBREFA, and it is my feeling that 

probably the best thing to do would take a step back and look at 

all of these requirements for SUBREFA panels, for peer review and 

all of that, and really decide if those things are necessary and add 

to the quality of the final product. 

The objective here for these statutes is to prevent harm, prevent 

workers from developing disease and disabilities, and if we have 

too many steps along the process, we never get to the final product. 

And it is not about the process. It is about the workers in the end 

who are harmed and develop diseases or die because of exposures 

at work. 

Mr. HARE. Thank you. 

Ms. SEMINARIO. Can I just add to that? When the National Academy of Sciences looked at what OMB had proposed on risk assessment—they put out a proposed bulletin. It went through public 

comment. It had an NAS panel. They had a lot of criticisms of the 

bulletin, but one of the main criticisms that they had was that bulletin, with all of its additional requirements, that the administration hadn’t done its own sort of cost-benefit analysis as to whether 

or not adding all these additional requirements had any benefit, 

had any benefit with respect to the outcome, and the benefit being 

not one of processing. 

The Occupational Health and Safety and Mine Acts are, as Dr. 

Monforton said, to protect workers. All right? That should be the 

main goal. So how does this add to the protection of workers? And 

I would say that in looking at this proposal here, it does nothing 

in that regard and would be quite detrimental. So, again, I think 

imposing additional requirements is not needed. 

And as I said, NAS also said that agencies needed to look at that 

when they were developing their risk assessment approaches to see 

if it added anything and was necessary and shouldn’t lose sight of 

what essentially the purposes of their statutes were. 

Chairwoman WOOLSEY. The gentleman’s time has expired. 

I am going to ask a question, and then the Ranking Member is 

going to give us his closing remarks, and then I will give my closing remarks, and you will all be excused. But let us get to what 

I think the main question is, Mr. Secretary. The White House Chief 

of Staff, Josh Bolten, issued a memo in May stating that no new 

52

regulations should be proposed after June 1, 2008, absent extraordinary circumstances. Can you describe why—well, describe the extraordinary circumstances in this case. Why is this extraordinary? 

Mr. SEQUEIRA. Madam Chairman, respectfully I disagree with 

your characterization of the Bolten memo. It, in fact, does not say 

that agencies cannot issue regulations after June 1. 

Chairwoman WOOLSEY. What does it say? 

Mr. SEQUEIRA. I don’t have a copy in front of me. 

Chairwoman WOOLSEY. Read it, please. 

Mr. SEQUEIRA. I said I don’t have a copy. 

Ms. SEMINARIO. I have a copy. 

Chairwoman WOOLSEY. And that is what it says, right? 

Ms. SEMINARIO. It says, ‘‘Except in extraordinary circumstances, 

regulations to be finalized in this administration should be proposed no later than June 1, 2008, and final regulations should be 

issued no later than November 1, 2008.’’ So either they are——

Mr. SEQUEIRA. I am sorry. She is asking the——

Ms. SEMINARIO. They are out of compliance with the memo, or 

they don’t intend to finalize it by the end of this administration. 

Chairwoman WOOLSEY. So my question to you, what are the extraordinary circumstances in this case other than putting one more 

roadblock into OSHA procedures to save life and health of workers? 

Mr. SEQUEIRA. The Department has not cited any extraordinary 

circumstances with regard to this rulemaking. 

Chairwoman WOOLSEY. Then why is this rulemaking more important than diacetyl, for example? 

Mr. SEQUEIRA. I have never said that it is, Madam Chairman. 

Chairwoman WOOLSEY. Well, it is preempting other actions that 

should be taken. 

Mr. SEQUEIRA. Actually I don’t believe that it is. This regulation 

is rather short. I think in a Word document, it is maybe 25 pages 

long. The three most recent standards issued by OSHA, I believe, 

were somewhere in the order of 400 to 700 pages long. The cranes 

and derricks rule that they are currently working on is in excess 

of 1,200 pages. 

Chairwoman WOOLSEY. It doesn’t matter how many pages. 

Whose life is being saved, whose health is better because of what 

we are doing? 

Mr. Johnson, you had something you wanted to say. Then I am 

going to ask our two women witnesses——

Mr. JOHNSON. Just on the last round of questions, it is true that 

obviously the OSHA Act was intended to protect workers. It was 

not a limitless grant of discretion to OSHA to create a risk-free environment. 

The OSHA Act also contains, quote, ‘‘that the Secretary in promulgating regulations must use the best available evidence and the 

latest available scientific data in the field.’’ Best available evidence, 

latest scientific data in the field, those concepts are from the statute. They are in the quality guidance——

Chairwoman WOOLSEY. Okay. Thank you, I don’t see how that 

relates to new standards, but we will see. 

Ms. Seminario, and then Dr. Monforton are going to be our cleanup batter for the witnesses. 

Ms. Seminario, you are first. 

53

Ms. MONFORTON. I just want to reiterate and make sure the committee understands that in the regulation, it specifically says that 

when MSHA and OSHA make major steps in rulemaking such as 

proposing a rule, that documents are to be published on regulations.gov within 14 days. This proposal purports to be something 

about best practices, but they don’t follow their own because there 

is nothing in regulations.gov that supports this rulemaking. They 

haven’t even followed their own best practices that they are proposing in this rule. It is very problematic when you are trying to 

comment on a proposed rule when you don’t have any of the substantive documents that were used to develop it. 

Chairwoman WOOLSEY. Okay, thank you. 

Ms. Seminario, you are our clean-up batter. 

Ms. SEMINARIO. Just to say that, again, this rule is being put forward in the name of improved transparency and notice to the public, but with the rule no notice was given that it was even under 

development, and certainly as far as transparency, we have had a 

little information, and as far as opportunity for comment, there is 

virtually none. So it violates, as Dr. Monforton said, what is being 

proposed here, but more importantly it will hurt workers. It will 

delay rules, very important rules like diacetyl and silica, which 

would mean that workers will be exposed. 

We have gone through 71⁄2 years, it will be eight years come January 2009, with only one occupational health rule being issued, and 

we would like the next administration to move forward quickly to 

put those standards in place to propose the silica rule, the diacetyl 

rule so workers aren’t exposed and their lives can be saved. That 

has what we think the priority of the next administration should 

do, not starting all over at the beginning of the process. Thank you. 

Chairwoman WOOLSEY. Mr. Wilson. 

Mr. WILSON. Thank you, Chairwoman Woolsey, for this hearing 

today. And I appreciate all of the witnesses, your input. I want to 

thank the Secretary and the Department. I wish you well as we are 

all working somewhat together and working on behalf of reducing 

workplace accidents and deaths. So I thank all of you for being 

here today, and I want to thank the staff, too. I will tell you Loren 

Sweatt is an amazing person putting up with us. Thank you. 

Chairwoman WOOLSEY. Thank you, Mr. Wilson. 

I want to thank all of you for being here today. You are excellent 

witnesses. It was very informative, and I believe there is one issue 

in all of these discussions that we can agree on, that there are 

major problems at OSHA and MSHA when it comes to issuing protective standards. However, we do differ on the nature of the problem. DOL seems to think that the paralyzed regulatory process requires even more years of review and even more delay. However, 

for those of us who believe that OSHA’s and MSHA’s job is to protect America’s workers, the real problem is the inexcusable delays 

in standard setting which is actually leaving workers exposed to 

deadly hazards. 

Congress gave OSHA and MSHA broad authority to issue enforced, strong workplace safety and health standards. Over the 

years the courts and this administration also have made it tougher 

to issue these standards, adding even more time to the process. We 

need to look at ways to reform the standard-making process so that 

54

it actually provides workers with the protection that they need on 

a timely basis. 

But this administration has utterly failed to fulfill its obligation 

to the American worker. While it should have been working full 

speed ahead to issue protective standards, it has instead been busy 

with this secret rule, a rule that subverts congressional intent to 

help workers, and it is being rushed through without proper consideration. 

Again, I want to thank the witnesses for your testimony, particularly coming to us on such short notice, and I want to assure you 

that we will continue to fight right here for American workers to 

ensure that any ill-conceived proposal won’t see the light of day, 

particularly this one. 

So as previously ordered, Members will have 14 days to submit 

additional materials for the hearing record. Any Member who wishes to submit follow-up questions in writing to the witnesses should 

coordinate with Majority staff within 14 days. 

Without objection, the hearing is adjourned. 

[Whereupon, at 11:50 a.m., the subcommittee was adjourned.]

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