[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]


 
                     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


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                    COMMITTEE ON EDUCATION AND LABOR

                  GEORGE MILLER, California, Chairman

Dale E. Kildee, Michigan, Vice       Howard P. ``Buck'' McKeon, 
    Chairman                             California,
Donald M. Payne, New Jersey            Senior Republican Member
Robert E. Andrews, New Jersey        Thomas E. Petri, Wisconsin
Robert C. ``Bobby'' Scott, Virginia  Peter Hoekstra, Michigan
Lynn C. Woolsey, California          Michael N. Castle, Delaware
Ruben Hinojosa, Texas                Mark E. Souder, Indiana
Carolyn McCarthy, New York           Vernon J. Ehlers, Michigan
John F. Tierney, Massachusetts       Judy Biggert, Illinois
Dennis J. Kucinich, Ohio             Todd Russell Platts, Pennsylvania
David Wu, Oregon                     Ric Keller, Florida
Rush D. Holt, New Jersey             Joe Wilson, South Carolina
Susan A. Davis, California           John Kline, Minnesota
Danny K. Davis, Illinois             Cathy McMorris Rodgers, Washington
Raul M. Grijalva, Arizona            Kenny Marchant, Texas
Timothy H. Bishop, New York          Tom Price, Georgia
Linda T. Sanchez, California         Luis G. Fortuno, Puerto Rico
John P. Sarbanes, Maryland           Charles W. Boustany, Jr., 
Joe Sestak, Pennsylvania                 Louisiana
David Loebsack, Iowa                 Virginia Foxx, North Carolina
Mazie Hirono, Hawaii                 John R. ``Randy'' Kuhl, Jr., New 
Jason Altmire, Pennsylvania              York
John A. Yarmuth, Kentucky            Rob Bishop, Utah
Phil Hare, Illinois                  David Davis, Tennessee
Yvette D. Clarke, New York           Timothy Walberg, Michigan
Joe Courtney, Connecticut            [Vacancy]
Carol Shea-Porter, New Hampshire

                     Mark Zuckerman, Staff Director
                Sally Stroup, Republican Staff Director
                                 ------                                

                 SUBCOMMITTEE ON WORKFORCE PROTECTIONS

                LYNN C. WOOLSEY, California, Chairwoman

Donald M. Payne, New Jersey          Joe Wilson, South Carolina,
Timothy H. Bishop, New York            Ranking Minority Member
Carol Shea-Porter, New Hampshire     Tom Price, Georgia
Phil Hare, Illinois                  John Kline, Minnesota


                            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


                     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 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 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.
    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 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 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 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:]

    
    
    
    
    
    
    
    
    
    
    
    
    
    
                                ------                                

    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.
    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.
    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 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 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)
     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.
            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.
    \2\ Letter from scientists to Secretary of Labor Elaine Chao, 
August 14, 2008, (Attachment A)
    \3\ Letter from Georges Benjamin, MD, Executive Director, American 
Public Health Association, to Secretary of Labor Elaine Chao, August 
12, 2008 (Atachment B)
    \4\ The 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 (time-weighted 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.
    \5\ Occupational 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.
    \6\ The Honorable Charlie Norwood, Opening Statements at hearings 
of the Subcommittee on Workforce Protections: ``Making Sense of OSHA 
Rulemaking: A Thirty Year Perspective,'' June 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.
    \9\ Lowell 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. Sec. 651
    \11\ 30 U.S.C. Sec. 801, et seq 12 Section 6(b)(5) of the 
Occupational Safety and Health Act of 1970 (29 U.S.C. Sec. 651), and 
Section 101(a)(6)(A) of the Federal Mine Safety and Health Act of 1977 
(30 U.S.C. Sec. 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).
    \16\ Section 6(b)(5) of OSH Act.
    \17\ The Presidential/Congressional Commission on Risk Assessment 
and Risk Management. ``Risk Assessment and Risk Management in 
Regulatory Decision-Making.'' Final Report, Vol. 2, 1997.
    \18\ OSHA 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.
    \19\ The 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)
    \20\ The 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.
    \23\ The 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.
    \25\ Lewis R. Bush Administration Tries To Slow Workplace Toxin 
Rules. ProPublica, July 23, 2008. At: http://www.propublica.org/
article/bush-administration-tries-to-slow-workplacetoxin-rules-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.
    \27\ OSHA 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 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\
---------------------------------------------------------------------------
    \1\ Original documents and chronology of events can be accessed at: 
http://www.defendingscience.org/case--studies/Secret-DOL-Rule.cfm.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \2\ The 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.
---------------------------------------------------------------------------
    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 Post\5\ and a request 
from Senator Edward Kennedy (D-MA) and Congressman George Miller (D-CA) 
to be briefed by DOL about its proposal.\6\
---------------------------------------------------------------------------
    \4\ Monforton, 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/.
    \5\ Leonnig, CD. U.S. rushes to change workplace toxin rules. 
Washington Post. July 23, 2008; Page A01.
    \6\ Monforton, C. Congress demands briefing on Chao's mystery 
proposal for risk assessment. July 10, 2008. http://
thepumphandle.wordpress.com/2008/07/10/congress-demands-briefing-on-
chaosmystery-proposal-for-risk-assessment/.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \7\ NRC. Science and Judgment in Risk Assessment. 1994. p. 217.
---------------------------------------------------------------------------
    The attempt to weaken the definition of a working life is contrary 
to the health-protective 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.
---------------------------------------------------------------------------
    \8\ OSH Act of 1970, Section 6(b)(5); Mine Act of 1977, Section 
101(a)(6)(A).
---------------------------------------------------------------------------
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,
    ``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: [email protected]

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: [email protected]

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

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.)

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

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 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, non-
asbestisform 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 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 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 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 ``case-by-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 Business 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.
    \3\ Presidential/Congressional Commission on Risk Assessment and 
Risk Management, Framework for Environmental Health Risk Management, 2 
Final Report 133 (1997).
    \4\ OMB/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 requirements 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 7\1/2\ 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.
    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.
     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 silica 
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 (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 last-minute 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 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.
    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.
    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 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 
Department 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 foreign 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.
    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.
    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.
    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 notice-and-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 Executive 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 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 
clean-up batter for the witnesses.
    Ms. Seminario, you are first.
    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 7\1/2\ 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 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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