[House Hearing, 109 Congress]
[From the U.S. Government Publishing Office]


 
       EXAMINING THE USE OF NON-CONSENSUS STANDARDS IN WORKPLACE
                           HEALTH AND SAFETY

=======================================================================

                                HEARING

                               before the

                 SUBCOMMITTEE ON WORKFORCE PROTECTIONS

                                 of the

                         COMMITTEE ON EDUCATION
                           AND THE WORKFORCE
                     U.S. HOUSE OF REPRESENTATIVES

                       ONE HUNDRED NINTH CONGRESS

                             SECOND SESSION

                               __________

                             April 27, 2006

                               __________

                           Serial No. 109-36

                               __________

  Printed for the use of the Committee on Education and the Workforce



 Available via the World Wide Web: http://www.access.gpo.gov/congress/
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            Committee address: http://edworkforce.house.gov


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                COMMITTEE ON EDUCATION AND THE WORKFORCE

            HOWARD P. ``BUCK'' McKEON, California, Chairman

Thomas E. Petri, Wisconsin, Vice     George Miller, California,
    Chairman                           Ranking Minority Member
Michael N. Castle, Delaware          Dale E. Kildee, Michigan
Sam Johnson, Texas                   Major R. Owens, New York
Mark E. Souder, Indiana              Donald M. Payne, New Jersey
Charlie Norwood, Georgia             Robert E. Andrews, New Jersey
Vernon J. Ehlers, Michigan           Robert C. Scott, Virginia
Judy Biggert, Illinois               Lynn C. Woolsey, California
Todd Russell Platts, Pennsylvania    Ruben Hinojosa, Texas
Patrick J. Tiberi, Ohio              Carolyn McCarthy, New York
Ric Keller, Florida                  John F. Tierney, Massachusetts
Tom Osborne, Nebraska                Ron Kind, Wisconsin
Joe Wilson, South Carolina           Dennis J. Kucinich, Ohio
Jon C. Porter, Nevada                David Wu, Oregon
John Kline, Minnesota                Rush D. Holt, New Jersey
Marilyn N. Musgrave, Colorado        Susan A. Davis, California
Bob Inglis, South Carolina           Betty McCollum, Minnesota
Cathy McMorris, Washington           Danny K. Davis, Illinois
Kenny Marchant, Texas                Raul M. Grijalva, Arizona
Tom Price, Georgia                   Chris Van Hollen, Maryland
Luis G. Fortuno, Puerto Rico         Tim Ryan, Ohio
Bobby Jindal, Louisiana              Timothy H. Bishop, New York
Charles W. Boustany, Jr., Louisiana  [Vacancy]
Virginia Foxx, North Carolina
Thelma D. Drake, Virginia
John R. ``Randy'' Kuhl, Jr., New 
    York
[Vacancy]

                       Vic Klatt, Staff Director
        Mark Zuckerman, Minority Staff Director, General Counsel
                                 ------                                

                 SUBCOMMITTEE ON WORKFORCE PROTECTIONS

                   CHARLIE NORWOOD, Georgia, Chairman

Judy Biggert, Illinois, Vice         Major R. Owens, New York
    Chairman                           Ranking Minority Member
Ric Keller, Florida                  Dennis J. Kucinich, Ohio
John Kline, Minnesota                Lynn C. Woolsey, California
Kenny Marchant, Texas                Timothy H. Bishop, New York
Tom Price, Georgia                   [Vacancy]
Thelma Drake, Virginia               George Miller, California, ex 
Howard P. ``Buck'' McKeon,               officio
    California,
  ex officio


                            C O N T E N T S

                              ----------                              
                                                                   Page

Hearing held on April 27, 2006...................................     1

Statement of Members:
    Norwood, Hon. Charlie, Chairman, Subcommittee on Workforce 
      Protections, Committee on Education and the Workforce......     1
        Prepared statement of....................................     3
    Owens, Hon. Major R., Ranking Minority Member, Subcommittee 
      on Workforce Protections, Committee on Education and the 
      Workforce..................................................     4
        Prepared statement of....................................     8
        Newspaper articles:
            ``Need WTC Delayed Death Bill,'' Chief Leader 
              Editorial, April 21, 2006..........................     5
            ``OSHA Comes Up Short on Workplace, Safety-Program 
              Evaluations, Report Shows,'' Washington Post, April 
              26, 2006...........................................     6

Statement of Witnesses:
    Chajet, Henry, Esq., Patton Boggs, LLP.......................    25
        Prepared statement of....................................    27
    Marcucci, Elizabeth, safety director, Gonnella Baking Co., on 
      behalf of the American Bakers Association..................    11
        Prepared statement of....................................    13
    Mirer, Franklin E., Ph.D., CIH, director, UAW Health and 
      Safety Department, International Union, United Automobile, 
      Aerospace & Agricultural Implement Workers of America (UAW)    21
        Prepared statement of....................................    23
    Ruddell, James, director of environment and safety, Franklin 
      Industrial Minerals, on behalf of the National Stone, Sand 
      and Gravel Association.....................................    18
        Prepared statement of....................................    19

Additional Materials Supplied:
    Letter submitted by the National Ready Mixed Concrete 
      Association................................................    40
    Prepared statement of the Independent Lubricant Manufacturers 
      Association................................................    41
    Letter submitted by David Felinski, safety director, the 
      Association for Manufacturing Technology, Secretariat, ANSI 
      B11 series reports.........................................    47
    Prepared statement of Andrew P. Morriss, Galen J. Roush 
      Professor of Business Law & Regulation, co-director of 
      Center for Business Law & Regulation, Case Western Reserve 
      University School of Law, senior scholar, Mercatus Center 
      at George Mason University.................................    52
    Prepared statement of the Precision Machined Products 
      Association................................................    57
    Statements and letters from the American Conference of 
      Governmental Industrial Hygienists (ACGIH).................    59



       EXAMINING THE USE OF NON-CONSENSUS STANDARDS IN WORKPLACE
                           HEALTH AND SAFETY

                              ----------                              


                        Thursday, April 27, 2006

                     U.S. House of Representatives

                  Subcommittee on Workforce Protections

                Committee on Education and the Workforce

                             Washington, DC

                              ----------                              

    The subcommittee met, pursuant to call, at 10:35 a.m., in 
room 2175, Rayburn House Office Building, Hon. Charlie Norwood 
[chairman of the subcommittee] presiding.
    Present: Representatives Norwood, Biggert, Kline, Owens, 
Kucinich, and Woolsey.
    Staff present: Byron Campbell, Legislative Assistant; Steve 
Forde, Communications Director; Rob Gregg, Legislative 
Assistant; Richard Hoar, Professional Staff Member; Kimberly 
Ketchel, Deputy Press Secretary; Molly McLaughlin Salmi, Deputy 
Director of Workforce Policy; Deborah L. Emerson Samantar, 
Committee Clerk/Intern Coordinator; Loren Sweatt, Professional 
Staff Member; Jody Calemine, Labor Counsel; Michele Evermore, 
Legislative Associate/Labor; Tylease Fitzgerald, Legislative 
Assistant/Labor; Peter Galvin, Senior Legislative Associate; 
Rachel Racusen, Press Assistant; Marsha Renwanz, Legislative 
Associate/Labor; and Mark Zuckerman, Minority Staff Director.
    Chairman Norwood [presiding]. A quorum being present, the 
Subcommittee on Workforce Protections will now come to order.
    First, I would like to start by noting that today is ``take 
our daughters and sons to work'' day. And I would like to 
welcome any students that may be with us today, and note that 
this can be an important day to demonstrate the importance of 
education and for exposing children to the many future career 
opportunities that will be available to them in this country's 
workplace.
    We are meeting here today to hear testimony on examining 
the use of non-consensus standards in workplace health and 
safety. If you would, we have some definitions up, and as I 
continue, I hope you can see those. They are a little small, 
but I hope you can read them.
    Under committee rule 12(b), opening statements are limited 
to the chairman and the ranking minority member of the 
subcommittee. Therefore, if other members have statements, they 
may be included in the hearing record.
    With that, I ask unanimous consent for the hearing record 
to remain open for 14 days to allow member statements and other 
extraneous material referenced during the hearing to be 
submitted in the official hearing record. Without objection, so 
ordered.
    Today we are going to take a look at an issue that has been 
the focus of previous oversight by this subcommittee. It is an 
issue of great interest and, frankly, of great concern to me: 
the ongoing practice by the Department of Labor, whereby DOL 
incorporates by reference non-consensus standards set by 
outside standard-setting organizations in the hazard 
communication rule.
    Do we have anybody here from DOL? That is real unfortunate. 
They will be here next time at the panel, I promise you.
    Some of you may recall that the subcommittee held hearings 
on this very topic in 2002. I am curious to see if any 
improvements have been made since 2002 or if the people are 
still facing the problems we heard about in 2002.
    At the outset, I would like to note that there are several 
lawsuits challenging DOL's so-called ``incorporation'' 
practice. One such case involves the American Conference of 
Government Industrial Hygienists, which was invited, but 
declined to testify at today's hearing.
    Regardless of the pending lawsuits, I am interested in 
hearing how the incorporation-by-reference practice impacts the 
regulated community and its overall role in health and safety 
regulations at the Department of Labor.
    Before we go any further, let me please draw your attention 
to the monitors on my right and left, which display the 
definition of a national consensus standard under the OSH Act. 
According to the statute, that is what Congress likes, the term 
``national consensus standard'' means any occupational safety 
and health standard or modification thereof which, one, has 
been adopted and promulgated by a nationally recognized 
standards-producing organization under procedures whereby it 
can be determined by the secretary that persons interested and 
affected by the scope or provision of the standard have reached 
substantial agreement on its adoption. That is No. 1 on a 
consensus standard.
    No. 2, it was formulated in a manner which afforded for 
diverse views to be considered; and three, has been designated 
as such a standard by the secretary, after consultation with 
other appropriate Federal agencies.
    You will note that there is no corresponding definition in 
the OSH Act of a non-consensus standard. The OSH Act simply 
does not recognize any outside standard that is not consistent 
with the principles outlined right here. That is a very 
important distinction that is basically at the center of this 
debate.
    Critics of the incorporation-by-reference practice, several 
of whom are witnesses today, maintain that the heart of the 
problem exists in standard setting bodies that do not allow for 
stakeholder input. By comparison, if DOL were to promulgate 
standards within the hazard communication rule, a myriad of 
Federal regulations would apply to the promulgation of these 
regulations.
    To begin with, DOL would have to provide the regulated 
community with public notice by way of the Federal Register, so 
says Congress. A notice and comment rulemaking would be 
required, so says Congress.
    DOL would also be required to defend the adoption of any 
standard as legal, assure the standard's technical feasibility, 
and evaluate the standard's impact on small business, so says 
Congress. In some cases, a negotiated rulemaking could be 
entered into between DOL, the affected industry, and the 
relevant worker representatives. However, none of these 
important processes are required when DOL incorporates a non-
consensus standard by reference. This chairman believes that is 
illegal and we are going to find out at the end of the day 
whether it is or is not.
    Now, I want to be clear. My goal here is to ensure 
transparency in the rulemaking process. The employees, their 
representatives, and the regulated industries have a right to 
provide input into the regulatory process, so says Congress.
    I also believe that government employees should have access 
to professional development. There is nothing wrong with that. 
However, I strongly believe that the system governing the 
relationship between a government employee and his or her 
association with a non-consensus standard-setting organization 
must be fundamentally fair and ethically acceptable. We will 
get into that during this hearing.
    I look forward to hearing from our witnesses today about 
how that might be possible, to achieve that, and exploring 
other ideas to strengthen the regulatory process regarding 
health and safety standards.
    It is now my pleasure to yield to the ranking member, my 
friend Mr. Owens, for whatever opening statement he wishes to 
make.
    [The prepared statement of Mr. Norwood follows:]

 Prepared Statement of Hon. Charlie Norwood, Chairman, Subcommittee on 
    Workforce Protections, Committee on Education and the Workforce

    Today we are going to take a look at an issue that has been the 
focus of previous oversight by this Subcommittee. It is an issue of 
great interest and, frankly of continued concern to me--the ongoing 
practice by the Department of Labor, whereby DOL incorporates, by 
reference, non-consensus standards set by outside standard-setting 
organizations in the hazard communication rule.
    Some of you may recall that the Subcommittee held hearings on this 
very topic in 2002. I am curious to see if any improvements have been 
made or if the people are still facing the problems we heard about in 
2002.
    At the outset, I would like to note that there are several lawsuits 
challenging DOL's so-called ``incorporation'' practice. One such case 
involves the American Conference of Government Industrial Hygienists 
(ACGIH), which was invited--but declined--to testify at today's 
hearing.
    Regardless of the pending lawsuits, I am interested in hearing how 
the incorporation by reference practice impacts the regulated 
community, and its overall roll in health and safety regulations at the 
Department of Labor.
    Before we go any further, let me please draw your attention to the 
monitors on my right and left, which display the definition of a 
national consensus standard under the OSH Act. According to the 
statute:
    ``The term national consensus standard means any occupational 
safety and health standard or modification thereof which (1) has been 
adopted and promulgated by a nationally recognized standards-producing 
organization under procedures whereby it can be determined by the 
Secretary that persons interested and affected by the scope or 
provision of the standard have reached substantial agreement on its 
adoption, (2) was formulated in a manner which afforded for diverse 
views to be considered, and (3) has been designated as such a standard 
by the Secretary, after consultation with other appropriate Federal 
agencies.''
    You will also note that there is no corresponding definition of a 
non-consensus standard, because the OSH Act does recognize any outside 
standard that is not consistent with the principles outlined above. 
That is a very important distinction that is at the center of this 
debate.
    Critics of the incorporation by reference practice, several of whom 
are witnesses today, maintain that the heart of the problem exists in 
standard setting bodies that do not allow for stakeholder input. By 
comparison, if DOL were to promulgate standards within the hazard 
communication rule, a myriad of federal regulations would apply to the 
promulgation of those regulations.
    To begin with, DOL would have to provide the regulated community 
with public notice by way of the Federal Register. A notice and comment 
rulemaking would be required.
    DOL would also be required to defend the adoption of any standard 
as legal, assure the standard's technical feasibility, and evaluate the 
standard's impact on small business. In some cases, a negotiated 
rulemaking could be entered into between DOL, the affected industry, 
and relevant worker representatives.
    However, none of these important processes are required when DOL 
incorporates a non-consensus standard by reference.
    Now I want to be clear; my goal here is to ensure transparency in 
the rulemaking process. The employees, their representatives, and the 
regulated industries have a right to provide input in the regulatory 
process.
    I also believe that government employees should have access to 
professional development. However, I strongly believe that the system 
governing the relationship between a government employee and his/her 
association with a non-consensus standard setting organization is 
fundamentally fair and ethically acceptable.
    I look forward to hearing from our witnesses today about how that 
might be possible, and exploring other ideas to strengthen the 
regulatory process regarding health and safety standards.
                                 ______
                                 
    Mr. Owens. Thank you, Mr. Chairman.
    Tomorrow is Workers Memorial Day. On April 28, we honor the 
thousands of American workers killed on the job each year in 
such grievous incidents as scaffolding collapses, unprotected 
falls, explosions, machinery upheavals, and ditch collapses.
    Between 5,000 and 6,000 Americans die each year as a result 
of such serious workplace hazards and safety lapses. From New 
York to California, we join surviving family members, 
coworkers, friends and community residents in mourning their 
untimely deaths. Most importantly, we seek accountability to 
prevent such wrongful workplace deaths in the future.
    This Workers Memorial Day is especially noteworthy given 
the way the year started. It began with a massive explosion at 
the Sago underground coal mine in Upshur County, West Virginia, 
that trapped 13 miners. Cable News Network provided round-the-
clock coverage of delayed rescue attempts and anxious family 
members awaiting news of their loved ones.
    We all know how that initial story ended, with 12 
mineworkers found dead and the sole survivor near death due to 
severe oxygen deprivation. The story of repeated and severe 
safety violations at Sago mine and dereliction of duty at the 
Federal Mine Safety and Health Administration continues to 
unfold as the Federal and state investigations continue.
    In addition to the 12 coal mineworkers killed at Sago, 14 
other coal miners have been killed on the job this year. They 
have been killed in mine fires, roof collapses, machinery 
failures, and like scenarios. These deaths occurred at mines 
other than Sago in West Virginia and elsewhere in Pennsylvania, 
Kentucky, Alabama, Maryland and Utah.
    In the first 4 months of 2006, 26 coal miners have been 
killed on the job, which is more than the number killed in all 
of 2005 all together. Coal miner fatalities are soaring and it 
is our responsibility, as members sitting on the congressional 
subcommittee with jurisdiction over MSHA, to address this 
serious crisis.
    Mr. Chairman, today's hearing does not focus or even touch 
upon the crisis of mineworker deaths. Neither does it address 
ways to address pressing worker safety issues under the 
jurisdiction of the Occupational Safety and Health 
Administration. Two such OSHA issues are unavoidable, given the 
front-page attention they are getting in newspapers across the 
country. They are also the responsibility of this subcommittee, 
given our jurisdiction over OSHA.
    First, there is the ever-rising death toll of those first 
responders who went to Ground Zero in New York for rescue and 
recovery work after the terrorist attacks of 9/11. Earlier this 
month, a New Jersey medical examiner cited ``Ground Zero'' as 
the cause of death of a detective involved in 9/11 recovery 
work. According to the autopsy report of 34-year-old Detective 
James Zagroda, there was no other explanation for the presence 
of innumerable foreign body granulomas, such as fiberglass, in 
his lungs than his work sifting for human remains and evidence 
in the Ground Zero rubble.
    Congressional oversight is called for here because OSHA 
declined at that time to enforce worksite safety standards at 
Ground Zero. Although the OSHA Web site declares that no lives 
were lost in the Ground Zero cleanup, deaths like Detective 
Zagroda's that are directly attributable to Ground Zero toxins 
now begin to keep turning up. OSHA's failure to require the use 
of appropriate personal protective equipment at Ground Zero 
merits immediate congressional investigation.
    I request unanimous consent that an article about Detective 
Zagroda's death be inserted in the record.
    Chairman Norwood. So ordered.
    [The information referred to follows:]

           [From the Chief Leader Editorial, April 21, 2006]

                      Need WTC Delayed Death Bill

    A New Jersey Medical Examiner's finding that a Detective who was 
involved in the recovery efforts at the World Trade Center site died 
because of the toxins he was exposed to has intensified the push of 
uniformed union leaders for a bill granting line-of-duty death benefits 
in such cases.
    It should be increasingly clear that such treatment is warranted.
    The autopsy by Dr. Gerard Breton of the Ocean County M.E.'s Office 
found ``the presence of innumerable foreign body granulomas that are 
distributed throughout the lung tissue'' of Det. James Zadroga. 
Fiberglass was among the substances discovered in his lungs.
    There was no other explanation for finding those materials in the 
lungs of a 34-year-old man than his work sifting through the rubble at 
the Trade Center site looking for survivors, bodies, and evidence.
    The ruling is the first conclusive finding that an emergency worker 
was killed as a direct cause of time spent at Ground Zero. There have 
been several other deaths, however--involving firefighters and 
Emergency Medical Service workers--where exposure to the deadly toxins 
at the site was almost certainly the cause.
    Governor Pataki last year signed into law a bill that grants job-
related disability pensions to those public employees who were unable 
to continue working because of illnesses they contracted--often years 
after exposure--from work related to the rescue and recovery efforts at 
the Trade Center and other sites where bodies or rubble were 
transported.
    As the death toll begins to rise, the Legislature and the Governor 
must look to do something more for those whose work there winds up 
costing them their lives. Detective Zadroga's survivors, including his 
4-year-old daughter, Tylerann, are entitled to eight years of 
disability pension payments, which are paid at three-quarters of his 
final salary. If his case was classified as a line-of-duty death by the 
NYPD, the family would be entitled to the equivalent of his final 
year's pay until Tylerann was 19, and until 23 if she were a full-time 
student for that long.
    This could get expensive for the city, since it is clear that some 
of these cases take years to manifest themselves. But it and the 
state--in other words, we, the public--owe that much to those who put 
themselves in harm's way, sometimes not realizing the extent of the 
danger because of pronouncements by both Federal and city officials 
that the air in the vicinity was of acceptable quality.
    Those who pay with their lives should have their families properly 
compensated to honor their sacrifice.
                                 ______
                                 
    Mr. Owens. Second is OSHA's failure to enforce appropriate 
safety standards at recovery and reconstruction worksites in 
the Katrina-affected Gulf Coast area. Again, numerous reports 
have surfaced in the press of Gulf Coast workers afflicted with 
rashes, lesions, and respiratory distress. The respiratory 
symptoms are now so widespread among these workers that doctors 
and other medical experts commonly refer to them as a ``Katrina 
cough.''
    In the aftermath of Hurricanes Katrina and Rita, OSHA's top 
political appointee announced the agency would not enforce 
workplace safety rules in the Gulf region. So for a 
considerable period of time, there was no enforcement of the 
OSHA rule on personal protective equipment, requiring employers 
to provide all workers with adequate masks, gloves and other 
appropriate safeguards.
    Now, those unprotected workers exposed to Katrina toxins 
are suffering from asthma, respiratory distress and other 
illnesses. Again, this merits immediate congressional 
oversight.
    Mr. Chairman, this morning's hearing flatly ignores the 
urgent need for such oversight of dangerously inadequate 
enforcement of U.S. safety laws at both MSHA and OSHA. Yet we 
are reminded of OSHA's inadequate safety enforcement in a new 
GAO report which documents OSHA's failure to conduct 
inspections of Federal worksites.
    This GAO report further documents OSHA's failure to 
establish a national strategy for targeting worksites with 
higher rates of injury and illness for inspection. This 
subcommittee should call GAO to testify about these failures at 
OSHA, as well as recommended solutions.
    I ask unanimous consent that an article about the new GAO 
report that appeared in yesterday's Washington Post be included 
in the record. The report is entitled ``Death on the Job: The 
Toll of Neglect.''
    Chairman Norwood. So ordered.
    [The information referred to follows:]

               [From the Washington Post, April 26, 2006]

 OSHA Comes Up Short on Workplace, Safety-Program Evaluations, Report 
                                 Shows

                            By Stephen Barr

    The Occupational Safety and Health Administration does not perform 
many safety inspections at federal workplaces and has not conducted any 
agency-wide evaluations of federal safety programs in the last six 
years, according to a recently released congressional report.
    In addition, OSHA has not turned in a report on federal agency 
safety programs to the president since fiscal 2000, even though OSHA is 
required by a White House directive and regulations to review the 
programs each year, the report by the Government Accountability Office 
said.
    ``OSHA's oversight of federal agencies' safety programs is not as 
effective as it could be because the agency does not use its 
enforcement and compliance assistance resources in a strategic 
manner,'' the GAO report said.
    Officials at OSHA acknowledged they have problems with their 
enforcement and compliance strategies ``but noted that they have 
relatively few staff dedicated to federal agency oversight,'' the 
report said. The Labor Department, OSHA's parent agency, generally 
agreed with the findings, GAO said.
    The GAO report was requested by Sens. Arlen Specter (R-Pa.) and Tom 
Harkin (D-Iowa), the chairman and ranking member of the Senate 
Appropriations subcommittee that oversees the Labor Department. ``This 
GAO report assists in determining what further steps can be taken to 
ensure that workers have safe conditions and that violations are 
closely monitored,'' Scott Hoeflich, a spokesman for Specter, said.
    During the past decade, more than 800 federal employees died from 
work-related accidents, with 47 deaths occurring in 2004, the most 
recent year that GAO could collect data from federal agency reports.
    Although the size of the federal workforce has decreased by 6 
percent in the past decade, GAO found that workers' compensation costs 
remained fairly constant, about $1.52 billion in 2004, compared with 
about $1.54 billion in fiscal 1995, after adjusting for inflation.
    Claims involving traumatic injuries decreased slightly, to 74,322 
in 2004 from 76,633 in 1995, GAO said. The injuries included sprains 
and strains of ligaments, muscles and tendons, sprains and strains of 
the back, bruises and cuts, GAO said.
    A smaller number of employees filed claims involving non-traumatic 
injuries, such as hearing loss and carpal tunnel syndrome, GAO found. 
Those claims decreased to 5,903 in 2004 from 8,508 in 1995, GAO said.
    Federal agencies are among the nation's largest employers. While 
many employees work in low-risk offices, large numbers are employed in 
hospitals, prisons, forests, parks and manufacturing.
    For the report, GAO collected data from 57 agencies, representing 
about 80 percent of the federal workforce. The GAO survey found that 
eight agencies did not have procedures to ensure that an injured 
employee was seen promptly by a doctor, while 12 agencies did not have 
programs offering injured employees light-duty alternatives to help 
them return to work more quickly.
    The report said 23 agencies did not have computer systems for 
collecting information about workplace hazards and whether they were 
corrected in a timely manner.
    A new rule, which took effect last year, requires agencies to keep 
logs of workplace injuries and could be useful in helping OSHA target 
inspections in the future, GAO said.
    OSHA officials told GAO that they also hope to rely on data being 
collected under a 2004 White House initiative. The ``Safety and Health 
and Return to Employment'' initiative seeks to reduce federal workers 
compensation claims and to get more injured federal employees back to 
work.
    But GAO said some agency officials see the initiative as ``a paper 
exercise,'' and GAO concluded ``the impact of the initiative on 
agencies' safety programs is not clear.''
    At noon today, Robert M. Tobias, director of public sector 
executive education at American University, will be the guest on 
Federal Diary Live on washingtonpost.com and will take questions from 
federal employees. Stephen Barr may be reached at [email protected].
                                 ______
                                 
    Mr. Owens. That said, I want to also call attention to the 
fact that Dr. Frank Mirer, a distinguished witness requested by 
members of the minority, is here with us this morning. As 
director of health and safety at the United Auto Workers 
International Union, Dr. Mirer will address the need for OSHA 
to set standards for certain hazardous chemicals now 
threatening worker health and safety. I welcome him to this 
hearing and look forward to hearing his very relevant 
testimony.
    In closing, Mr. Chairman, I request that a summary of a new 
report by the AFL-CIO commemorating Worker Memorial Day be 
included in the record in its entirety. That report is entitled 
``Death on the Job: The Toll of Neglect, a National State-by-
State Profile of Worker Safety and Health in the United 
States.''
    Chairman Norwood. So ordered.*
---------------------------------------------------------------------------
    *Submitted and placed in permanent archive file, Death on the Job: 
The Toll of Neglect. A National and State-by-State Profile of Worker 
Safety and Health in the United States, 15th Edition. April 2006, 
http://www.aflcio.org/mediacenter/resources/reports.cfm. (Submitted for 
the record by Rep. Owens)
---------------------------------------------------------------------------
    Mr. Owens. Thank you.
    [The prepared statement of Mr. Owens follows:]

  Prepared Statement of Hon. Major R. Owens, Ranking Minority Member, 
 Subcommittee on Workforce Protections, Committee on Education and the 
                               Workforce

    Mr. Chairman, tomorrow is Workers Memorial Day. On April 28th, we 
honor the thousands of American workers killed on-the-job each year in 
such grievous incidents as scaffolding collapses, unprotected falls, 
explosions, machinery upheavals, and ditch collapses. Between 5000-6000 
Americans die each year as a result of such serious workplace hazards 
and safety lapses. From New York to California, we join surviving 
family members, co-workers, friends and community residents in mourning 
their untimely deaths. Most importantly, we seek accountability to 
prevent such wrongful workplace deaths in the future.
    This Workers Memorial Day is especially noteworthy given the way 
the year started. It began with a massive explosion at the Sago 
underground coal mine in Upshur County, West Virginia that trapped 13 
miners. Cable News Network (CNN) provided round-the-clock coverage of 
delayed rescue attempts and anxious family members awaiting news of 
their loved ones. We all know how that initial story ended--with 12 
mineworkers found dead and the sole survivor near death due to severe 
oxygen deprivation. The story of repeated and severe safety violations 
at Sago mine and dereliction of duty at the federal Mine Safety and 
Health Administration (MSHA) continues to unfold as the federal and 
state investigations continue.
    In addition to the 12 coal mineworkers killed at Sago, 14 other 
coal mineworkers have been killed on-the-job this year. They have been 
killed in mine fires, roof collapses, machinery failures, and like 
scenarios. These deaths occurred at mines other than Sago in West 
Virginia, and elsewhere in Pennsylvania, Kentucky, Alabama, Maryland 
and Utah. In the first 4 months of 2006, 26 coal mineworkers have been 
killed on the job, which is more than the total number killed in all of 
2005. [Last year, a total of 22 coal miners were killed on the job.] 
Coal miner fatalities are soaring and it is our responsibility, as 
Members sitting on the Congressional Subcommittee with jurisdiction 
over MSHA, to address this crisis.
    Mr. Chairman, today's hearing does not focus or even touch upon the 
crisis of mineworker deaths. Neither does it address ways to address 
pressing worker safety issues under the jurisdiction of the 
Occupational Safety and Health Administration (OSHA). Two such OSHA 
issues are unavoidable, given the front-page attention they are getting 
in newspapers across the country.
    They are also the responsibility of this Subcommittee, given our 
jurisdiction over OSHA.
    First is the ever-rising death toll of those first responders who 
went to Ground Zero for rescue and recovery work after the terrorist 
attacks of 9/11. Earlier this month, a New Jersey Medical Examiner 
cited ``Ground Zero'' as the cause of death of a detective involved in 
9/11 recovery work. According to the autopsy report of 34 year old 
Detective James Zadroga, there was no other explanation for the 
``presence of innumerable foreign body granulomas'' such as fiberglass 
in his lungs than his work sifting for human remains and evidence in 
the ``Ground Zero'' rubble.
    Congressional oversight is called for here because OSHA declined to 
enforce worksite safety standards at Ground Zero. Although the OSHA 
website declares that ``no lives were lost in the Ground Zero clean-
up,'' deaths like Detective Zagroda's that are directly attributable to 
Ground Zero toxins keep mounting. OSHA's failure to require the use of 
appropriate personal protective equipment at Ground Zero merits 
immediate Congressional investigation. I request unanimous consent that 
an article about Detective Zagroda's death be inserted in the Record.
    Second is OSHA's failure to enforce appropriate safety standards at 
recovery and reconstruction work-sites in the Katrina-affected gulf 
coast. Again, numerous reports have surfaced in the press of Gulf coast 
workers afflicted with rashes, lesions, and respiratory distress. The 
respiratory symptoms are now so widespread among these workers that 
doctors and other medical experts commonly refer to them as a ``Katrina 
cough.'' In the aftermath of Hurricanes Katrina and Rita, OSHA's top 
political appointee announced the agency would not enforce workplace 
safety rules in the Gulf region. So for a considerable period of time, 
there was no enforcement of the OSHA rule on personal protective 
equipment (PPE), requiring employers to provide all workers with 
adequate masks, gloves and other appropriate safeguards. Now, those 
unprotected workers exposed to Katrina toxins are suffering from 
asthma, respiratory distress and other illnesses. Again, this merits 
immediate Congressional oversight.
    Mr. Chairman, this morning's hearing flatly ignores the urgent need 
for Congressional oversight of dangerously inadequate enforcement of 
U.S. safety laws at both MSHA and OSHA.
    Yet we are reminded of OSHA's inadequate safety enforcement in a 
new GAO report which documents OSHA's failure to conduct inspections of 
federal worksites. This GAO report further documents OSHA's failure to 
establish a ``national strategy for targeting worksites with high rates 
of injury and illness for inspection.'' This Subcommittee should call 
GAO to testify about these failures at OSHA and well as recommended 
solutions. I ask unanimous consent that an article about the new GAO 
report that appeared in yesterday's Washington Post be included in the 
Record.
    That said, Dr. Frank Mirer, a distinguished witness requested by 
Members on this side of the aisle, is here with us this morning. As 
Director of Health and Safety at the United Auto Workers International 
Union (UAW), Dr. Mirer will address the need for OSHA to set standards 
for certain hazardous chemicals now threatening worker health and 
safety. I welcome him to this hearing and look forward to hearing his 
testimony.
    In closing, Mr. Chairman, I request that a summary of a new report 
by the AFL-CIO commemorating Worker Memorial Day be included in the 
Record in its entirety.
                                 ______
                                 
    Chairman Norwood. Before we begin, I would like to make 
note that the Labor Department has arrived. Steve Silbiger is 
here.
    Mr. Silbiger, you better pay attention to this hearing and 
take a lot of notes. Is anybody else here from the Labor 
Department? If they are, please be recognized. I say to you, 
take notes. You are next.
    We have a panel of distinguished witnesses today. Frankly, 
I am very eager to hear their testimony, but I would like to 
yield to my vice chairman, Judy Biggert, to introduce our first 
witness.
    Mrs. Biggert. Thank you, Mr. Chairman.
    It is my pleasure this morning to introduce Elizabeth 
Marcucci. Ms. Marcucci is the corporate safety director at 
Gonnella Baking Company, which has a number of facilities in 
the Chicago area, including one just outside my district in 
Aurora, and of course their bread is in all the stores in my 
area.
    Ms. Marcucci holds a bachelor's degree from St. Joseph 
College in Indiana. She has been working for Gonnella Baking 
Company for the last 17 years. Over this period, she has saved 
the company millions of dollars in worker compensation costs 
and received various awards for her loss prevention measures.
    In 2003, she won the National Safety Council's 
Distinguished Service to Safety Award, which is the highest 
honor bestowed on any individual by the council, in recognition 
for outstanding service in the field of safety.
    She is a member of NCS and also the American Bakers 
Association, on whose behalf she is testifying today. She 
serves on the safety committee of that organization and the 
Greater Chicago Safety Council.
    She is also a certified defensive driving instructor, a CPR 
first-aid instructor, and an 8-hour incident responder for 
hazardous material spills, and a 40-hour incident commander for 
hazardous materials. She keeps herself pretty busy.
    So I appreciate her willingness to attend today's hearing 
and provide her insight into workplace safety.
    I look forward to hearing your testimony.
    I yield back. Thank you, Mr. Chairman.
    Chairman Norwood. Ms. Marcucci, welcome. We are glad you 
are here. This is easy as pie. I am going to introduce 
everybody else, and then we will come back to you. You are a 
hazardous driving instructor? I have a staff member named 
``Crash'' that might need some of your guidance. We will talk 
after this hearing is over with.
    [Laughter.]
    I would like to now recognize Mr. Jim Ruddell, who is the 
director of environment and safety for Franklin Industrial 
Minerals. He holds a master's degree in soil science and a 
bachelor's degree in forest science. Franklin Industrial 
Minerals has been in operation since 1910 and operates various 
types of mining facilities in Tennessee, Georgia, Alabama, 
Florida and Texas. Their operations produce over 5 million tons 
of minerals annually.
    Mr. Ruddell, you are most welcome.
    Next is Dr. Frank Mirer, who is the director of the health 
and safety department, International Union for the United Auto 
Workers. Dr. Mirer heads the technical coordination unit for 
safety policies for UAW. He represents the union before 
administrative agencies regarding occupational safety and 
health research. Dr. Mirer holds a Ph.D. in organic chemistry 
from Harvard University and is a certified industrial 
hygienist. This witness has been invited by the minority 
members of the subcommittee.
    Anyway, we are very glad you are here.
    [Laughter.]
    Dr. Mirer. I was going to find out whether that----
    Chairman Norwood. You don't want to hear the rest of it.
    Dr. Mirer. I want to hear that.
    [Laughter.]
    Chairman Norwood. Mr. Henry Chajet is a partner at Patton 
Boggs. Mr. Chajet counsels and represents clients in 
environmental health and safety matters, focusing on crisis 
management, dispute resolution, trial and appellate litigation, 
standard setting, and liability prevention, and regulatory and 
congressional proceedings.
    He defends investigations and enforcement actions by OSHA, 
MSHA, EPA, DOT, NTSB, NIOSH and other Federal and state 
agencies, as well as in related tort claims in criminal cases. 
Mr. Chajet represents plaintiff businesses who have sued the 
Department of Labor, claiming it is improperly relying on ACGIH 
in its standard-setting. He holds a degree from Case Western 
Reserve Law School and University.
    I would like to remind all the members that we will be 
asking questions of the witnesses after their testimony. In 
addition, rule 2 imposes a 5-minute limit on all questions.
    With that, can I call you Elizabeth?
    Ms. Marcucci. That is fine.
    Chairman Norwood. Elizabeth, you are up.

  STATEMENT OF ELIZABETH MARCUCCI, SAFETY DIRECTOR, GONNELLA 
                         BAKING COMPANY

    Ms. Marcucci. Good morning.
    Thank you, Congresswoman Biggert, for your kind remarks.
    Mr. Chairman, distinguished members of the subcommittee, 
thank you for the invitation to address this hearing. My name 
is Liz Marcucci, and I am the corporate safety director for 
Gonnella Baking Company in Chicago, Illinois. I also chair the 
American Bakers Association's safety committee and am 
testifying on behalf of the ABA.
    ABA is the trade association that represents the nation's 
wholesale baking industry. Gonnella is a family owned bakery 
operation with three facilities in the greater Chicago land 
area, with approximately 350 employees. Our facilities make a 
variety of high-quality fresh and frozen bakery goods, 
including hand-crafted artisan breads and rolls. Gonnella is 
the proud hot-dog supplier of the world champion Chicago White 
Sox, Chicago Cubs and Chicago Bulls.
    I started out as assistant safety director with Gonnella in 
1984, and now my responsibilities include the management of all 
company safety and health programs, including regulatory 
accountability and workers compensation. In addition to ABA, I 
serve in several leadership capacities with the National Safety 
Council. The NSC honored me and the employees of Gonnella 
Baking Company with the distinguished service to safety award.
    I am a safety advocate for all of our employees and their 
families. In a family business, this takes on added 
significance. Safety is our company's first priority in all 
decisions, from the president to our highly trained and valued 
employees. The baking industry is concerned with one so-called 
consensus organization, the American Conference of Governmental 
Industrial Hygienists, ACGIH. ACGIH's threshold limit values, 
TLVs, are used by OSHA for permissible exposure limits, PELs, 
and could be used by OSHA for so-called ``general duty clause'' 
violations.
    In addition, the 23-state OSHA plans rely heavily upon the 
TLVs. These states need to have confidence in the procedures 
and results of the consensus standard-setting organizations 
upon which they rely. ABA learned that ACGIH issues TLVs of 
questionable scientific basis. Making matters worse in the 
development of a TLV, it is done with no public input.
    During its development of a TLV on flour dust, ABA was 
unable to get any information on the development of the TLV. My 
written statement covers these issues in greater detail.
    We were concerned because the TLV was 30 times lower than 
the OSHA nuisance limit and two times lower than the OSHA 
exposure limit for hazardous substances. The TLV relies on a 
controversial method different from the monitoring commonly 
used in the management and enforcement of respiratory 
exposures.
    ABA contracted with Sandler Occupational Medicine 
Associates, SOMA, to conduct an analysis of ACGIH's 
justification for the TLV. They found that the TLV is based on 
``very limited, indefinite and unconfirmed information and is 
not substantiated.'' SOMA also found that ``the scientific 
evidence does not provide a basis for control of exposure at 
specific thresholds, particularly exposure to flour dust, for 
purposes of preventing or limiting flour allergens 
sensitization and other work-related effects.''
    At the November 2001 subcommittee hearing, ABA articulated 
that TLVs come with some real consequences. ABA pointed out how 
a baking company in Kentucky was cited with a serious violation 
of the general duty clause and respiratory protection standards 
for failure to meet the TLV standard. The citation was 
withdrawn only when the company presented the SOMA study as a 
counterpoint to ACGIH's flawed analysis.
    Kentucky OSHA in its review of the science came to the same 
conclusion as the baking industry, that the TLV is not based on 
sound science. During the citation investigation, it was 
revealed that Kentucky OSHA adopted the ACGIH TLV in the 
mistaken belief that it was developed in cooperation with the 
baking industry. This came as a great shock to the ABA. 
Kentucky OSHA should not have to explain why the cited company 
based on an ACGIH TLV unwittingly thought it to be valid.
    The Kentucky OSHA citation should have required the 
immediate abatement of employees' exposure to flour dust above 
the ACGIH TLV with new ventilation systems and a full-face mask 
for respiratory protection. Few baking companies could meet the 
excessive engineering and respiratory requirements that would 
be required under this flawed TLV.
    Unfortunately, the recent activities of California 
Occupational Safety and Health Standards Board tell a more 
disturbing story. At the end of 2004, with little notice and 
fanfare, California adopted a number of ACGIH's new TLVs, 
including flour dust as its own permissible exposure limits. 
Last year, ABA petitioned the California Occupational Safety 
and Health Standards Board, asking that the new TLV for flour 
dust be rescinded, submitting the SOMA study as supporting 
documentation.
    In January, the board summarily rejected ABA's petition in 
language eerily similar to ACGIH's dismissal several years ago. 
Thankfully, however, California bakers have not been subjected 
to enforcement action.
    OSHA needs to be extremely careful in what type of 
information it relies upon for regulations and enforcement. 
While one can argue with specifics about NFPA or ANSI 
standards, at least the affected parties have a seat at the 
table. These are true consensus organizations. This is the 
proper and transparent way to ensure an outcome in which 
everyone can have confidence.
    We urge Congress to insist that OSHA utilize true consensus 
standards that meet minimum requirements for openness and 
participation. ABA also urges Congress to require OSHA to 
utilize scientific data and economic impact analysis that has 
been independently peer-reviewed. The OSH Act pertaining to the 
proper use of consensus standards should be enforced or 
strengthened to prohibit the use of ACGIH and similar 
unsubstantiated standards.
    We urge Congress to insist that OSHA avoid using ACGIH's 
TLVs as the basis for regulations and enforcement proceedings. 
OSHA should instruct the state OSHA plans to also refrain from 
utilizing TLVs. OSHA should be more diligent in utilizing its 
review and approval authority over state-plan states to ensure 
that only true consensus standards be utilized.
    Congress and OSHA should not just take ACGIH's word when it 
claims that ``regulatory bodies should view TLVs as an 
expression of scientific opinion.'' Congress should clearly 
communicate to Federal and state regulatory agencies that ACGIH 
itself does not believe its standards ``should be adopted as 
standards without an analysis of other factors necessary to 
make appropriate risk management decisions.''
    We applaud the chairman for his steadfast common sense 
leadership on this important issue. We encourage the 
subcommittee to aggressively move to correct these problems. 
Many companies are at risk of significant penalties and 
unnecessary abatement procedures based on ACGIH's scientific 
opinion, and not on facts.
    Again, Mr. Chairman and members of the subcommittee, I 
greatly appreciate this opportunity to present the views of the 
baking industry, and would be happy to answer any questions.
    [The prepared statement of Ms. Marcucci follows:]

  Prepared Statement of Elizabeth Marcucci, Safety Director, Gonnella 
        Baking Co., on Behalf of the American Bakers Association

I. Introduction and Summary
    The American Bakers Association (ABA) thanks the House Subcommittee 
on Workforce Protections, and especially Chairman Charles Norwood, for 
holding this critically important hearing on Examining the Use of Non-
Consensus Standards in Workplace Health and Safety. ABA greatly 
appreciates the opportunity to present its views again to the 
Subcommittee.
    By way of background, the ABA is the trade association that 
represents the nation's wholesale baking industry. Its membership 
consists of more than 200 wholesale bakery and allied services firms. 
These firms comprise companies of all sizes, ranging from family-owned 
enterprises to companies affiliated with Fortune 500 corporations. 
Together, these companies produce approximately 80 percent of the 
nation's baked goods. The members of the ABA collectively employ tens 
of thousands of employees nationwide in their production, sales and 
distribution operations. The ABA, therefore, serves as the principal 
voice of the American wholesale bakery industry.
    The ABA and its member companies long have devoted substantial 
efforts to enhance workplace safety and health programs in the industry 
in general, and to share expertise for the benefit of injury and 
illness prevention activities at individual facilities. Towards these 
ends, ABA's Safety Committee--comprised of corporate safety directors 
at ABA-member companies of various sizes--has routinely focused on the 
impact of OSHA compliance obligations on company operations, as well as 
other pro-active measures that reduce illnesses and injuries in bakery 
production and distribution activities. As a result, many wholesale 
baking operations have improved their safety and health performance in 
recent years. For a number of industry facilities, these improvements 
have been reflected in the rates of injuries and illnesses that are 
recorded on OSHA logs, as well as their workers compensation cost 
experience, which reflect both the frequency and severity of 
compensable work-related injuries and illnesses. The ABA, through the 
active participation of its Safety Committee, also has participated in 
numerous consensus standard setting proceedings over the years--
including the American National Standards Institute, the National Fire 
Protection Association, and the Baking Industry Sanitation Standards 
Committee. The comments that follow largely are based on the 
observations and experience of the corporate safety directors who are 
active members of the ABA's Safety Committee.
    My name is Liz Marcucci and I am the Corporate Safety Director for 
Gonnella Baking Company based in Chicago, Illinois. I am also Chair of 
the American Bakers Association Safety Committee. I am pleased to be 
testifying today on behalf of the ABA. Gonnella is a moderately sized 
family owned company operating 3 bakery facilities in the greater 
Chicago land area. Gonnella Baking Company employs approximately 350 
employees. Our facilities make a variety of high quality bakery goods 
including handcrafted Artisan breads, bagels, rolls croissants and 
sweet goods. Many of these products are used throughout the country by 
retail and food service companies. Gonnella also is proud to be the hot 
dog bun supplier for the World Champion Chicago White Sox, Chicago 
Cubs, Milwaukee Brewers and the Chicago Bulls.
    My responsibilities at Gonnella include the management of all 
company safety and health programs and initiatives, including 
regulatory accountability and workers compensation. I like most of the 
family, started working with Gonnella when I was 15 years old. As with 
most family owned companies, I have done just about everything at least 
once from packaging bread to sweeping floors. I began my safety career 
with the company in 1984 as the Assistant Safety Director.
    Since that time, with Gonnella's support and encouragement, I 
assumed leadership roles in not only the ABA but the National Safety 
Council as well. I serve on both the Food and Beverage Section and the 
Business & Industry Executive Committees for the National Safety 
Council. In 2001 the National Safety Council paid me and the employees 
at Gonnella a tremendous honor with the Distinguished Service to Safety 
Award.
    In my role as Corporate Safety Director for Gonnella, I work very 
closely with both facility leadership and production employees to help 
ensure our company is a safe and healthy place to work for all. As a 
family business this takes on added significance and I consider myself 
an advocate for all of our employees and their families in the ongoing 
business of maintaining a safe work environment. Gonnella is strongly 
committed to providing a safe and healthy workplace to our highly 
trained and valued employees. Safety is our company's first priority in 
all decisions, from the President to the production floor. This front 
line commitment to safety at all levels of our organization has helped 
us maintain superior performance when it comes to preventing the 
occurrence of significant injuries and illnesses in our facilities.
    In the past several years, the wholesale baking industry has become 
acutely concerned about one so-called consensus organization--the 
American Conference of Governmental Industrial Hygienists (ACGIH). 
ACGIH develops Threshold Limit Values (TLVs) on a variety of 
potentially harmful substances in the workplace. While ACGIH's TLVs are 
technically considered to be exposure guidelines and not have the 
weight of law, they are frequently used by OSHA as a foundation for 
Permissible Exposure Limits (PELs) and could be used by OSHA for so-
called ``general duty clause'', Section 5(a)(1) violations. Of greater 
concern is the reliance by reference to the TLVs in OSHA's Hazard 
Communication Standard.
    In addition, the 23 states that have adopted their own safety and 
health programs in lieu of the federal OSHA program rely heavily upon 
the TLVs that ACGIH develops. These states have a charter obligation to 
provide safety and health protection equal to or greater than the 
federal program. These states need to have confidence in the procedures 
and end results of the consensus standard setting organizations upon 
which they rely for guidance in developing their own standards and 
enforcement proceedings. In the case of ACGIH, the experience of the 
ABA has found them woefully lacking.
II. ACGIH Threshold Limit Value on Floor Dust
    In 1999, the ACGIH began the process of developing for the first 
time a threshold limit value for flour dust. The laudable goal of the 
proposed ACGIH TLV for flour dust was to eliminate flour dust as a 
possible sensitizing agent that could contribute to asthmatic 
conditions in baking industry employees.
    ACGIH announced that it was looking at establishing a level of .5 
milligrams per cubic meter (mg/m3) of inhalable dust. By way of 
comparison, the current ACGIH TLV for grain dust is 4 mg/m3 and the 
OSHA PEL for grain dust is 10 mg/m3 as an 8 hour Time Weighted Average 
(TWA). This is the standard as it applies to grain silos, grain mills 
and related industries. OSHA's current PEL for nuisance dust, of which 
flour dust is considered, is 15 mg/m3.
    ACGIH's newly proposed exposure standard to flour dust, which is a 
primary ingredient of the baking process, is a significant change from 
what had previously been administered by OSHA, the industry, or any 
other consensus standard setting organization--including ACGIH. The new 
exposure standard recommended by ACGIH was 30 times lower than what was 
regulated by OSHA for total dust exposure and twice the exposure limit 
enforced by OSHA for exposure to substances that would be commonly 
considered a more substantial respiratory hazard, such as copper dust. 
The new exposure recommendation presented by ACGIH was also based on an 
exposure monitoring methodology different from the total dust or 
respirable dust monitoring commonly used in the management and 
enforcement of respiratory exposures. The validity of this monitoring 
methodology is a subject of great debate within the industrial hygiene 
community.
    ABA and its Safety Committee were obviously concerned that there 
might be new evidence showing that employees in the baking industry 
were being exposed to conditions that could lead to serious adverse 
health conditions. ABA attempted to contact ACGIH for a better 
understanding of the science supporting their proposal and what 
opportunities there were to open a dialogue to discuss this important 
issue. ABA was informed that ACGIH does not provide affected industries 
with an opportunity to discuss TLVs under consideration or have a voice 
in their development. At best, ACGIH will occasionally allow a 
representative of an industry to address their organization.
    Particularly disturbing is that all attempts to find out any 
information--even a list of members of the Chemical Substances 
Committee--were ignored. Repeated phone calls, emails and 
correspondence were not acknowledged during the entire time that the 
ACGIH imposed ``decision clock'' was ticking. It became very clear that 
the ABA and the North American Millers Association (NAMA) were going to 
have to take serious steps to be heard in the process.
    In the spring of 2000, our organizations and the Canadian National 
Millers Association contracted with Sandler Occupational Medicine 
Associates (SOMA) to conduct a literature review of the documentation 
ACGIH was relying upon to determine whether to issue a TLV. In 
addition, we asked SOMA to determine if there was additional research 
material that could be helpful in determining whether a health risk 
existed.
    The findings of the SOMA review were clear and startling: the 
scientific evidence does not support the ACGIH TLV. In fact, the SOMA 
study concludes:
    ``Research in this area as reported by many independent studies has 
found that sensitization to flour dust does not account for a majority 
of reported symptoms in flour workers. This is based on the absence of 
evidence of flour sensitization in most symptomatic workers. Research 
findings support the conclusion that symptoms in flour workers are 
primarily non-allergic and that flour dust primarily acts as a non-
specific irritant rather than as a sensitizer or allergy-causing 
substance.''
    ``Published data pertaining to exposure thresholds for flour-
related effects, including sensitization and irritant effects are very 
limited. Furthermore, the data that serves as the basis for the TLV-TWA 
for flour sensitization were not intended to be definitive for 
identifying exposure thresholds and do not provide confirmation of the 
appropriateness of the TLV-TWA.''
    ``In conclusion, the TLV-TWA provided in the ACGIH document is 
based upon very limited, indefinite and unconfirmed information and is 
not substantiated by the accumulated scientific evidence regarding 
flour dust exposure. From a scientific and occupational medical 
perspective it is surprising that a TLV-TWA would be developed based 
upon such limited data. The scientific evidence does not provide a 
basis for control of exposure at specific thresholds, particularly 
exposure to flour dust for purposes of preventing or limiting flour 
allergen sensitization and other work-related effects. The * * * 
accumulated research does not provide scientifically-based, 
appropriately-derived support in the areas relevant to exposure 
threshold determination as provided in the ACGIH document.''
    ABA, NAMA and CNMA submitted the SOMA study to the ACGIH Chemical 
Substances/Threshold Limit Value Committee for their review with a 
request that the ACGIH should withdraw the proposed TLV on flour dust. 
After six months of wrangling with ACGIH, we received a summary 
dismissal of our request that the TLV be withdrawn. Ironically, ACGIH 
failed to address the very serious issues raised in our letter and in 
the SOMA study--they merely stated that ``ACGIH received no substantive 
comments on the proposal during the year it was on the NIC. ACGIH 
believes that the Documentation for the flour dust TLV and the research 
cited therein adequately support the TLV.''
    It was not until your leadership, Mr. Chairman, at the hearing in 
November of 2001 to investigate the reliance upon ACGIH's 
unsubstantiated reviews that ACGIH finally agreed to meet with the 
baking and milling industries. Only after you skillfully pointed out 
the fact that ACGIH itself recognizes that it is not a consensus 
organization and does not follow any of the elements of consensus 
organizations did they agree to at least meet. Unfortunately, the 
meeting was completely without merit and as the other witnesses have 
stated not much has changed.
    All of this is not intended to air our dirty laundry as it were, 
but merely to point out that a so-called ``consensus organization'' is 
conducting its scientific evaluations and decision making completely in 
private, with no outside input or oversight, and thus no confidence in 
the final work product. It is no wonder that ACGIH has found itself 
battling numerous lawsuits and may continue to face legal action. Their 
work product--at least in the case of flour dust--is unsubstantiated, 
unreliable, and completely secretive.
III. Basis for Regulation and Enforcement
    As I stated earlier, OSHA and the state OSHA plans rely upon the 
ACGIH TLVs as a basis for regulations and enforcement activities. It is 
for these reasons that ACGIH's processes should be open and responsive 
to the public and should instill the highest level of confidence by 
both regulators and the regulated community.
    At the November 2001 hearing, Travis Nichol with Bakery Chef in 
Louisville, Kentucky articulated, these TLVs come with real 
consequences. Mr. Nichol, testifying on behalf of ABA, pointed out how 
his company was cited with a serious violation of the General Duty 
Clause and Respiratory Protection Standards for failure to meet the TLV 
standard. The citation was only withdrawn when his company presented 
the SOMA study as a counterpoint to ACGIH's flawed analysis and 
Kentucky OSHA in its review of the scientific foundation came to the 
same conclusion of the baking industry--that it is based on bad 
science.
    During the citation investigation and follow up it was revealed 
that Kentucky OSHA had adopted the ACGIH TLV as a consensus standard on 
the belief that it was developed by a reputable resource in cooperation 
with the wholesale baking industry. As you can imagine, this came as a 
great shock to the ABA and those industry safety professionals that 
have serious reservations regarding this new TLV.
    The citation originally presented by Kentucky OSHA would have 
required that the company take immediate steps to abate employees' 
exposure to flour dust above the ACGIH TLV. This would have resulted in 
employees, who previously had not been required to wear respiratory 
protection under OSHA exposure standards, to start wearing full face 
mask respirators like those worn by the Hazardous Materials workers. 
This would present an extraordinary leap in hazard management for 
bakery facilities of any size. It is likely that few employers in the 
baking industry could ever meet the excessive engineering and 
respiratory requirements that would be required under this flawed TLV.
    It appears that this is due to the fact that the ACGIH TLV simply 
is not a ``consensus'' standard for our industry. Our industry manages 
employee safety based on sound science and facts, which have been 
thoroughly peer reviewed in an open and democratic manner with our 
government. Kentucky OSHA should not have been put in the position of 
explaining why they cited a company based on an ACGIH TLV it 
unwittingly thought to be valid. It should have confidence, without 
going thorough a review of the recommendation with the industry or 
other experts directly involved with the issue, that the TLV is valid, 
supported and proper.
    Unfortunately, the recent activities by California's Occupational 
Safety and Health Standards Board tell a more disturbing story. At the 
end of 2004, with little notice and fanfare, California adopted a 
number of ACGIH's new TLVs, including flour dust, as it's own 
permissible exposure limits. Last year, ABA petitioned the California 
Occupational Safety and Health Standards Board asking for the new TLV 
for flour dust to be rescinded, submitting the SOMA study as supporting 
documentation for our request. In January, the Board summarily rejected 
ABA's petition in language eerily similar to ACGIH's dismissal several 
years ago. Thus far, however, California bakers have not been subjected 
to enforcement action.
    One final point to bring to the Subcommittee's attention is that on 
many occasions, the ACGIH's TLVs are used in workers compensation 
proceedings. Each state sets its own standards as to what type of 
evidence can be admitted into a determination of work-related injury or 
illness. Many states again rely upon the TLVs with the belief that they 
are above question. As we have spelled out, in the case of the flour 
dust TLV, the evidence and process is clearly in question. Clearly, for 
a state workers compensation board to rely upon consensus standards in 
making important determinations involving compensation for work related 
injury or illness, they must be based on a solid foundation.
IV. Recommendations
    Clearly OSHA and the state OSHA plans need to be extremely careful 
regarding the type of information upon which they rely upon for 
regulations and enforcement. While one can argue specific points about 
NFPA or ANSI standards, at least the affected parties have ample 
opportunity to find out the details of the substance, abatement methods 
and also how the standard-setting process works. In all cases, those 
directly impacted have a seat at the table. They also have charter 
requirements that all issues raised during public comments need to be 
resolved by the issuing Committee. This is the only way to ensure an 
outcome in which everyone can have confidence.
    In the case of ANSI, ABA works closely with its industry partners, 
the equipment manufacturers of BEMA and the educational arm at the 
American Institute of Baking to review the voluntary consensus standard 
pertaining to bakery equipment, Z-50. As an industry utilizing ovens 
and flour silos with potential explosion hazards, we work closely with 
the NFPA on its consensus standards. Again, everyone has a seat at the 
table and a voice in the development process. Local, state and federal 
agencies that look to these organizations for assistance and guidance 
have confidence in the procedures and work product of these 
organizations.
    We strongly urge Congress to insist that OSHA utilize only data and 
true consensus standards that meet minimum requirements for openness 
and participation. In addition, we urge Congress to add further 
confidence in the regulatory process by requiring OSHA to utilize 
scientific data and economic impact analysis that has been 
independently peer-reviewed. At the very least, language in the 
Occupational Safety and Health Act pertaining to the proper use of 
consensus standards should be enforced or strengthened to prohibit the 
use of ACGIH and similar unsubstantiated standards.
    We also urge Congress in the strongest way possible to insist that 
OSHA avoid using ACGIH's TLVs as the basis for regulations and 
enforcement proceedings. OSHA also should instruct the state OSHA plans 
that--given numerous controversies involving ACGIH standards--states 
also should refrain from utilizing the TLVs. OSHA also should be more 
diligent in utilizing its review and approval authority over state plan 
states to ensure that only true consensus standards be utilized for 
enforcement and standard setting.
    While we are loath to have the federal government impact the 
states' ability to conduct workers compensation programs as they see 
fit, ABA recommends that OSHA clearly communicate to state workers 
compensation administrators that the ACGIH TLV process and product have 
come under question. Until such time that ACGIH conducts itself in an 
open and fair manner that ensures confidence in its work product, it 
should not be the basis for any local, state or federal regulatory or 
enforcement proceeding.
    Finally, while OSHA should continue to encourage its employees to 
participate in consensus standard setting organizations that meet basic 
open meetings and disclosure requirements, it should require them to 
push those organizations such as ACGIH that do not into changing their 
policies, or--alternatively--such agencies should withdraw the 
participation of their employees. Only then will the public be served 
in a way in which it can be confident of the results.
    Our greatest fear is that government agencies will continue down 
this dangerous path of unwittingly adopting recommendations of so-
called ``consensus'' organizations without first thoroughly examining 
the background of each issue. My hope is that we can count on our 
government to ensure democracy in the rules and standard setting 
process, due to the broad impact of those guidelines in multiple 
settings.
    Congress and OSHA should not just take ACGIH at its word when it 
claims that its standards are for informational purposes and that 
``regulatory bodies should view TLVs and BEIs as an expression of 
scientific opinion.'' In addition to clearly communicating to federal 
and state regulatory agencies that ACGIH does not believe its 
standards, ``should be adopted as standards without an analysis of 
other factors necessary to make appropriate risk management 
decisions'', Congress should ensure that OSHA and states do not rely on 
``scientific opinion'' as the basis for standards and enforcement..
    We applaud the Chairman for his steadfast leadership and 
commonsense approach on this important issue. We encourage the 
Subcommittee to move aggressively to correct the problems in the 
Occupational Safety and Health Act pertaining to non-consensus 
standards. Many companies are at risk of significant penalties and 
abatement procedures based on ACGIH's ``scientific opinion'' and not on 
facts. Thank you again for the opportunity to address this important 
issue.
                                 ______
                                 
    Chairman Norwood. Thank you very much, Liz.
    I failed to mention prior to starting that you have a red, 
yellow, green light in front of you. I am going to be very 
generous for everybody today with time, but when that red comes 
on, begin to think about it might be time to close it down so 
we can get to the questions.
    I would like to ask staff to put back up on the monitors 
the definition of ``consensus standards'' so our Labor 
Department people that are here can read them and write them 
down and memorize them.
    With that, Mr. Ruddell, you are certainly recognized.

STATEMENT OF JAMES RUDDELL, DIRECTOR OF ENVIRONMENT AND SAFETY, 
                  FRANKLIN INDUSTRIAL MINERALS

    Mr. Ruddell. Mr. Chairman, members of the subcommittee, my 
name is Jim Ruddell. I am director of environment and safety 
for Franklin Industrial Minerals. We are a crushed limestone 
operation with over 400 employees, with operations in Georgia, 
Tennessee, Texas and Florida.
    Thank you for the opportunity to appear before the 
subcommittee and testify on behalf of the National Sand, Stone 
and Gravel Association regarding ACGIH. Our concern is about 
the process by which it establishes threshold limit values or 
TLVs, that become de facto regulations by incorporation into 
regulatory standards developed by OSHA and MSHA.
    NSSGA is the world's largest mining association by product 
volume. Its member companies represent more than 90 percent of 
the crushed stone and 70 percent of the sand and gravel 
produced annually in the U.S. Approximately 117,000 men and 
women work in the aggregate industry. During 2005, a total of 
3.2 billion tons of crushed stone, sand and gravel valued at 
$17.4 billion were produced and sold in the United States.
    There are two important points I would like to leave with 
you today. One is that while ACGIH has a history of providing 
high-quality and useful information concerning health effects 
on chemical substances, it is not a consensus standard 
organization. The process by which it develops guidance 
information, including the threshold limit values of chemical 
substances, does not involve the wider audience or operate in 
the sunshine like other recognized consensus standard 
organizations.
    The second is the wide acceptance and incorporation by OSHA 
and MSHA of the ACGIH TLVs into the standards and regulations 
as if they were established by a consensus standard 
organization. In the case of the TLVs, whenever there is a new 
TLV adopted, it automatically changes the requirements under 
OSHA and MSHA. As a result, Federal standards are changed, 
bypassing the regulatory process where input can be provided.
    An important consideration is that many ACGIH members work 
for regulatory agencies such as MSHA and OSHA, the very same 
ones that write the regulations. Even though ACGIH has in place 
a conflict of interest requirement that all members of the TLV 
committee must sign, it may not be possible to differentiate 
between work at ACGIH and work for their employer.
    There are two recent examples of decision that affect the 
members of NSSGA. In one case, ACGIH published a notice of 
intent to change the existing TLV for calcium carbonate. ACGIH 
proposed reducing calcium carbonate by 90 percent based on a 
single German study of 32 individuals suggesting that the 
current level should be lowered because there is some evidence 
of nasal irritation. Calcium carbonate is an innocuous 
substance that is the main ingredient in Tums.
    A second example involves crystal and silica. A proposed 
standard went through the TLV committee and was reduced by 50 
percent. This reduction occurred while controversy continues 
about the quality of the scientific data supporting health 
effects and measurement methods of crystal and silica.
    The salient issue is that these TLVs are incorporated by 
reference in the OSHA and MSHA hazard communication standards. 
This standard requires that every time there is a change in 
relevant information, we must revise our material safety data 
sheets. Further, we must retrain our employees. This also 
causes concern and anxiety of the general public who use these 
basic materials every day and view the MSDS as government-
sanctioned public security warning systems.
    NSSGA understands the legislation is being developed to 
encourage development and promulgation of voluntary consensus 
standards. NSSGA supports the use of voluntary consensus 
standards.
    Mr. Chairman, that concludes my statement, and again thank 
you for the opportunity today.
    [The prepared statement of Mr. Ruddell follows:]

   Prepared Statement of James Ruddell, Director of Environment and 
Safety, Franklin Industrial Minerals, on Behalf of the National Stone, 
                      Sand and Gravel Association

    Mr. Chairman and Members of the Subcommittee: Thank you for the 
opportunity to appear before the Subcommittee today to testify on 
behalf of the National Stone, Sand & Gravel Association regarding the 
American Conference of Governmental Industrial Hygienists (ACGIH) and 
our concern about the process by which it establishes Threshold Limit 
Values, or TLVs, that become de facto regulations by incorporation into 
regulatory standards developed by the Occupational Safety and Health 
Administration (OSHA) and the Mine Safety and Health Administration 
(MSHA).
    Based near the nation's capital, NSSGA is the world's largest 
mining association by product volume. Its member companies represent 
more than 90 percent of the crushed stone and 70 percent of the sand 
and gravel produced annually in the U.S. and approximately 117,000 
working men and women in the aggregates industry. During 2005, a total 
of about 3.2 billion tons of crushed stone, sand and gravel, valued at 
$17.4 billion, were produced and sold in the United States.
    There are two important points I would like to leave with you 
today. One is that while the ACGIH has a rich history of providing high 
quality and useful information concerning the health effect of chemical 
substances, it is not a consensus standard organization. The process by 
which it develops guidance information, including the Threshold Limit 
Values of Chemical Substances, does not involve the wider audience or 
operate in the ``sunshine'' like those processes of other recognized 
consensus standard setting organizations or the Federal government.
    The second and just as important point is the wide acceptance and 
incorporation by the Federal agencies OSHA and MSHA of the ACGIH TLVs 
into their standards and regulations as if they were established by a 
consensus standard organization. In the case of the TLVs, whenever 
there is a new TLV adopted, it automatically becomes a new standard 
under OSHA and MSHA. As a result, the Federal standards are changed and 
bypass the regulatory process where input can be provided or it can be 
challenged if necessary.
    At its inception in 1938, the National Conference of Governmental 
Industrial Hygienists, which changed its name in 1946 to the American 
Conference of Governmental Industrial Hygienists, was one of only a few 
places where workplace exposure to hazardous substances was considered 
important. Initially, and until 2000, only members of the government 
and academic institutions could become members of the organization. In 
2000, limited membership was extended to allow members from other 
organizations additional opportunities to serve on appointed committees 
and the board of directors.
    An important consideration is that many governmental members work 
for regulatory agencies such as MSHA and OSHA, the very same ones that 
write regulations that incorporate the ACGIH TLVs. Even though the 
ACGIH has in place a conflict of interest requirement that all members 
of the TLV Committee must sign and agree to, it may not be possible to 
differentiate between work of ACGIH and work for their employer.
    During the war-time industrial buildup, the ACGIH recognized a need 
to identify, understand and control worker exposures to hazardous 
substances encountered in the workplace. The Threshold Limit Values for 
Chemical Substances, the TLV Committee, was established in 1941. The 
first exposure limits, known as maximum allowable concentrations, were 
established in 1950. These workplace exposure limits became known as 
the Threshold Limit Values (or TLVs) in 1951 and are still used today.
    In most cases, the quality and volume of scientific information 
available did not compare with what we typically expect today. The 
process by which the ACGIH established these TLVs was through a 
committee of practicing professionals who met to consider any 
information available. The committee made recommendations to the ACGIH 
Board of Directors who approved the TLVs. The process included placing 
a given substance on the ``Notice of Intended Changes'' list for a 
period of two years to allow time to receive input and judiciously 
consider the information. In earlier times, information was actively 
sought from industry because they had the information available that 
could help to make a decision. That collaborative process, however, no 
longer seems to work effectively.
    This model seemed to work quite well until the establishment of 
OSHA in 1970. OSHA was charged with the responsibility of regulating 
the workplace for protecting employee safety and health. When OSHA 
looked for a way to develop standards initially, they looked to 
consensus standards, such as the American National Standards Institute 
(ANSI), the American Society for Testing and Materials (ASTM) and the 
National Fire Protection Association (NFPA) in order to rapidly develop 
regulations for the protection of workers. At that time, there was no 
consensus organization setting exposure limits for workers. However, 
the ACGIH TLVs were in place and represented a considered list of 
hazardous substances where there was recognition of an exposure level 
that was believed to be safe for all workers. The 1971 TLVs were 
incorporated into the OSHA regulations as Permissible Exposure Limits 
(PELs) that must be met. In the case of the mining industry, the 1973 
TLVs were incorporated for the same purpose. For the most part, these 
still are the requirements.
    Today, the overall federal regulatory process is required to be 
more open-in the sunshine, so to speak-in order to allow for the input 
of all parties and consideration of data that is of high quality and 
scientifically valid in establishing a regulatory limit that everyone 
must meet. Hence, the recent Data Quality Act. Further, today's 
regulatory process requires the consideration of all available 
technical and economic feasibility data when setting permissible 
exposure limits for American workers.
    The ACGIH, however, is not a consensus organization because its 
internal decision-making process excludes many of the parties that may 
be affected by the decisions that are made. The ACGIH recognizes this 
as evidenced in the disclaimer published in every edition of the TLV 
Booklet that says:

                  * * * These recommendations or guidelines are 
                intended for use in the practice of industrial hygiene, 
                to be interpreted and applied only by a person trained 
                in this discipline. They are not developed for use as 
                legal standards and ACGIH does not advocate their use 
                as such.

    The ACGIH TLV process does not consider either technical or 
economic feasibility during its deliberations. While they accept input 
from interested parties, ACGIH is not required to act on the outside 
input received.
    Perhaps this is a two-part issue. The ACGIH clearly states that its 
TLVs are not to be used as regulatory limits, but the regulatory 
agencies incorporate them by reference and they become a standard 
affecting all employers without the full open, regulatory process 
required today.
    There are two recent examples of decisions that affect the members 
of the NSSGA.
    In one case, calcium carbonate, the ACGIH published a notice of 
intent to change the existing TLV for calcium carbonate. It proposed 
reducing the calcium carbonate TLV by 90 percent based on a single 
German study of 32 individuals suggesting that the current level should 
be lowered because there was some evidence of nasal irritation. Calcium 
carbonate, the simple main ingredient in TUMS, is an innocuous 
substance that is used as filler in paints, plastics, paper coatings, 
pharmaceuticals and various food grade substances. Even the white 
powder used to keep chewing gum from sticking to the wrapper is pure 
calcium carbonate. The NSSGA in cooperation with the Portland Cement 
Association and Industrial Minerals Association-North America retained 
a well-known toxicologist specializing in inhalation toxicology to 
review and comment on the relevance of the German study. This report 
was submitted to the ACGIH TLV Committee for their consideration in 
setting a new TLV for this material. It is not known whether the report 
was influential, but when ACGIH published its 2006 TLV Booklet, the 
original Notice of Intended Change to reduce the TLV had been replaced 
with a new one announcing the intention to remove the existing TLV and 
its supporting documentation from the TLV booklet, suggesting that even 
the original TLV might be inappropriate. Of course, it will be at least 
another year, perhaps two, for the final decision to be made.
    A second TLV for crystalline silica went through the TLV Committee 
and was significantly reduced for the second time since 2000. This 
reduction occurred while controversy continues about the quality of the 
scientific data supporting health effects and measurement methods of 
crystalline silica. Further, OSHA is in the midst of rulemaking on this 
particular substance where the issues of technical and economic 
feasibility must be considered.
    The salient issue is that these TLVs have been incorporated by 
reference in the OSHA Hazard Communication Standard. The standard 
requires that every time there is a change in relevant information (for 
example, a reduction in the TLV or a change in carcinogen 
classification) every manufacturer of a listed substance must change 
the material safety data sheets (MSDS) they are required to produce 
under the Hazard Communication Standard to reflect this new information 
within three months. This also causes unwarranted concern and anxiety 
on the part of the general public who use these basic materials 
everyday and view the MSDS as a government-sanctioned public security 
warning system that gives them the needed sense of security that use of 
these products will not harm them or their families. Random setting and 
withdrawal of TLVs calls into question the standard setting process 
itself as well as the integrity of the underlying scientific standard 
setting body.
    NSSGA understands that legislation to encourage development and 
promulgation of voluntary consensus standards by providing relief to 
standards development organizations is being developed. NSSGA support 
efforts to promote the use of voluntary consensus standards, which will 
encourage long-term growth and help maintain the competitiveness of 
U.S. enterprises around the world.
    Mr. Chairman, that concludes my statement. Again, thank you for the 
opportunity to appear before the Subcommittee today. I am happy to 
respond to any questions.
                                 ______
                                 
    Chairman Norwood. Thank you, Mr. Ruddell.
    Dr. Mirer, you are recognized.

  STATEMENT OF FRANKLIN E. MIRER, DIRECTOR, HEALTH AND SAFETY 
    DEPARTMENT, UNITED AUTOMOBILE, AEROSPACE & AGRICULTURAL 
               IMPLEMENT WORKERS OF AMERICA (UAW)

    Dr. Mirer. Thank you, Dr. Norwood, Mr. Owens. I might point 
out I am a Brooklyn boy, born and bred. I hope to return there 
later in life.
    My testimony today will focus on the need for OSHA to 
promulgate standards for a host of chemicals and what Congress 
can do to make this happen on the eve of Workers Memorial Day. 
We have copies of our poster over there. We hope you will look 
at it. We should be thinking about how we are going to protect 
workers.
    Chronic illness arising from long-term chemical exposures 
at work accounts for 90 percent of the known work-related 
mortality. You can see the names of our known victims on the 
back of our poster, but most of the victims of chemical 
exposures are not aware of the chemical cause of their illness.
    Reducing those known exposures is the most reliable and 
best opportunity to protect the lives and health of American 
workers. The fact is in the more than 3 decades OSHA has been 
in existence, OSHA has issued its new exposure limits for only 
17 agents and groups of agents. These rules radically 
transformed the allowable exposures for those chemicals from 
the 1968 levels. Protected workers transformed industries, and 
largely avoided the high costs projected by industry 
doomsayers, and we have heard quite a bit of doom here already.
    You have to think about what the consequences of OSHA not 
moving are, regardless of what you think about ACGIH, which are 
not in our view particularly protective levels or stringent 
levels. I only joined ACGIH after Henry sued them and drove 
them to the brink of bankruptcy. I figured I had to join them 
to support them.
    Chairman Norwood. The taxpayers are buying enough from 
them. They won't go bankrupt.
    Dr. Mirer. So let me talk about a real instance of what the 
consequences of not setting standards are. In November 2000, 
Dave Patterson, a machine operator at a brake systems plant in 
Mount Vernon, Ohio, began to get severely ill. In January, two 
additional members there, machinists J. J. Johnson and set-up 
man John Gooch were hospitalized for hypersensitivity 
pneumonitis, a serious disease that is like idiopathic 
extrinsic alveolitis. It can be fatal and lead to severe lung 
disorder.
    One of these victims filed an OSHA complaint. On February 
1, 2001, an OSHA inspector entered the factory, measured the 
exposures, issued no citation for metalworking fluids because 
the manufacturer, the employer, was found to be in compliance. 
Workers continued to get sick. NIOSH came in and you see the 
detail in my testimony. Several publications arose out of the 
incident, but I believe in my heart this problem went on for a 
whole year longer than it had to go on because of the lack of 
an OSHA standard.
    That is one of a dozen, or more than a dozen outbreaks we 
know about, many in our plants from metalworking fluids. In our 
testimony, you read the long, sad story of how long we have 
worked on trying to get a new OSHA standard through this, 
including a consensus process where the majority of the 
industry representatives, not all of them, simply refused to 
recognize the scientific data supporting the need for the 
standard.
    We had an 11-to-4 vote for OSHA to go forward on a 
standard, and yet OSHA and this administration withdrew it from 
their regulatory agenda, and then beat us in court over the 
need to go forward.
    The most visible demonstration of the impact of OSHA's 
failure to move forward on new exposure standards was, in my 
view, the World Trade Center. OSHA measured according to their 
standards and polled those workers. There were no violations. 
There was nothing to worry about, and we can see what the 
consequences of that are in the daily newspapers in New York 
every day.
    The chemical standards process has pretty much ground to a 
halt. We think the solution to this has to be broken 
legislatively, this particular impasse. First, OSHA should be 
required to meet as high a threshold to defend refusing a 
petition for a new standard, as it does to promulgate a new 
standard for chemical exposure.
    Second, contrary to what has been suggested here, Congress 
should authorize OSHA one more time to adapt the threshold 
limit values list that we have now, to bring us into the 21st 
century. I am also suggesting an escape clause where those that 
find substantial reasons from affected parties should go into 
the OSHA 6(b) rulemaking process with a time certain for coming 
out of it at the end.
    Just a word on consensus standards. Consensus standards are 
usually a negotiation between the equipment suppliers and the 
equipment users, where they address health and safety. They are 
usually a negotiation between the machine tool builders and the 
machine tool users for how to get a safety standard.
    These are interest groups. They are not scientific groups 
and they don't have representation from the affected employees 
except in very rare instances. So they are not the body to 
establish a scientific consensus or a scientific view.
    In conclusion, the UAW appreciates the opportunity to 
testify. We look forward to moving to improve protections for 
American workers, not to try and erode those professional 
bodies that are attempting to give advice to employers on how 
to protect their workers.
    Thank you very much.
    [The prepared statement of Dr. Mirer follows:]

  Prepared Statement of Franklin E. Mirer, Ph.D., CIH, Director, UAW 
 Health and Safety Department, International Union, United Automobile, 
      Aerospace & Agricultural Implement Workers of America (UAW)

    My name is Frank Mirer and I am the Director of the Health and 
Safety Department of the United Automobile, Aerospace, and Agricultural 
Implement Workers of American (UAW), International Union. The UAW would 
like to thank you for the opportunity to testify on the use of 
nonconsensus standards in workplace health and safety. My testimony 
will focus on the need for OSHA to promulgate standards for a host of 
chemicals and what Congress can do to make this happen. On the eve of 
Workers Memorial Day, we should be thinking about protecting workers.
    Chronic illness arising from long term chemical exposures at work 
accounts for 90% of known work-related mortality. Few of these victims 
are named on Workers Memorial Day, and many are not aware of the 
chemical cause of their illness. Reducing those known dangerous 
exposures is therefore the best opportunity to protect the lives and 
health of American workers. Recognizing the dangers of chemicals at 
work also would facilitate controlling those chemicals at home and in 
the community environment.
    When OSHA was established in 1968, it inherited a group of chemical 
exposure limits, based on the science of the '60s and before. Those 
limits were set with substantial involvement of scientists affiliated 
with the chemical industries through the American Conference of 
Governmental Industrial Hygienists (ACGIH). Those limits were not 
intended to meet the criteria for protection mandated by the OSHA law. 
Nevertheless, this was a place to start in regulating chemical 
standards.
    In the more than three decades that OSHA has been in existence, 
OSHA has issued standards for only 17 agents or groups of agents. These 
rules radically reduced allowable exposures from the 1968 levels, 
protected workers, transformed industries, and largely avoided high 
costs projected by industry doomsayers. Those costs incurred included 
wages of workers fabricating and maintaining control equipment, and 
cleaning the workplace, so these rules actually created jobs. OSHA 
should have issued rules for dozens more chemicals.
    The effects of OSHA failing to set new standards can sometimes be 
seen in victims we can name. Here's a real story, documented in the 
scientific literature and the popular press.
    In November 2000, Dave Patterson, a machine operator at a brake 
systems plant in Mt. Vernon, Ohio, initially reported breathing 
difficulties to his physician. In January 2001, machinist J.J. Johnson 
and set-up man John Gooch were hospitalized with hypersensitivity 
pneumonitis (HP), a serious disease that can lead to respiratory 
failure. Subsequently, additional HP cases developed as well as cases 
of bronchitis and occupational asthma (OA).
    On February 5, 2001, an OSHA inspector responded to a complaint 
from one of the victims. The inspector issued no citation for MWF 
exposure because they found management in compliance. OSHA gave 
management a clean bill of health for metalworking fluids.
    Workers continued to get sick. In June 2001, a National Institute 
for Occupational Safety and Health (NIOSH) Health Hazard Evaluation was 
called in by management and UAW Local 1939. By November 2001, 107 
workers (out of 400) had been placed on restriction and 37 remained on 
medical leave. NIOSH identified 14 with occupational asthma, 12 with 
hypersensitivity pneumonitis, three with occupational bronchitis.
    The UAW worked closely with TRW and NIOSH to protect our members. 
Ventilation was improved to bring exposure into compliance with UAW and 
NIOSH recommended limits. Eleven months after the first case, new cases 
stopped appearing, but some victims were still unable to return to 
work. Recent reports from our members and the press show that previous 
victims still suffer.
    This was one of at least a dozen ``outbreaks'' of illness and 
disability from HP in machining plants which are in compliance with 
OSHA's exposure limits. These outbreaks were and are epidemics of acute 
severe illness on top of the endemic risks of asthma, other respiratory 
conditions, and most likely cancer.
    Well before OSHA's 2001 inaction in Ohio, the problem was known to 
OSHA and to the industry. In 1993, the UAW petitioned OSHA for an 
emergency temporary standard for metalworking fluids based on research 
largely conducted jointly in the auto industry. OSHA denied that 
petition, but did convene an industry-labor-public health standards 
advisory committee. The automobile industry responded in 1995 and 1997 
by convening symposia on the health effects and control measures for 
exposure to metalworking fluids. Both concluded that the effects were 
real and controls were feasible. The UAW negotiated exposure limits 
lower than OSHA with the auto industry employers, as well as other 
control measures. The year 1997 also saw the crafting of an American 
National Standards Institute (ANSI) standard on mist control for 
machine tools and a workshop was held to identify the cause and 
prevention of hypersensitivity pneumonitis. The following year (1998) 
NIOSH completed a ``Criteria Document'' on metal working fluids (a 
proposal to OSHA for a standard), concurring with the UAW recommended 
limit. The OSHA Standards Advisory Committee voted 11-4 that OSHA issue 
a comprehensive standard to drastically reduce the mist levels to which 
workers are exposed and to enact strict requirements for fluid 
management. OSHA responded to the SAC report by issuing voluntary 
guidelines, but left the new standard on the regulatory agenda.
    So where was OSHA during the TRW outbreak? As workers were being 
hospitalized, an OSHA inspector was giving a ``clean bill of health'' 
to the plant, based on a 30+ year old standard that would allow a 
typical worker to inhale 1 pint of oil over the course of a working 
lifetime. And then, in October, 2001, OSHA deleted Metalworking Fluids 
(MWF) from the regulatory agenda, withdrawing the advanced notice of 
proposed rulemaking. OSHA acknowledged the respiratory illness from MWF 
exposure at prevailing and permitted exposure levels, but stated the 
asthma and hypersensitivity pneumonitis were ``rarely fatal.'' The UAW 
petitioned the 3rd Circuit Court of Appeals to compel OSHA to restart 
the rulemaking. On March 24, 2004, that Court deferred to OSHA's 
decision NOT to act or start setting a standard.
    Since 1970, scientific evidence and practical experience has 
identified workplace chemical causes of many instances of illness, 
disability and death among workers. Technical methods for estimating 
quantitative risks at various exposure levels--methods demanded by 
industry--demonstrate very large risks at very low exposures. Multiple 
studies have shown that widely distributed chemicals, like silica, are 
now known to cause cancer in humans. Lung cancer has been observed 
among workers exposed at levels permitted by the current OSHA standard 
and prevailing in American workplaces and at American construction 
sites. Organic dusts, like flour, are known to cause occupational 
asthma at exposure levels prevailing in American workplaces. A 
predictable fraction of asthma victims will die of that illness.
    The most visible recent demonstration of the impact of OSHA's 
failure to move forward on new exposure standards was at the World 
Trade Center recovery site. The scientific literature and popular press 
recount the ongoing toll of disability and even death among recovery 
workers. Those accounts fail to connect the dots, that OSHA, and EPA, 
correctly reported that none of the measured exposures at the site 
violated outdated OSHA standards.
    The standards process, when allowed to proceed according to law, 
drastically reduces permissible and actual exposures. The OSHA asbestos 
permissible exposure limit, revised several times, was cut to \1/50\ of 
what it was in 1970, and even this limit leaves behind a substantial 
cancer risk. We still pay for the legacy of those old, high exposures.
    Unfortunately, the chemical hazard standards process nearly ground 
to a halt in the last decade. The most recent rule protecting against 
cancer-causing chrome compounds was issued this year following a court 
order to regulate and a court decreed time limit to get it done. The 
mandated reduction is not sufficient, but it's something. The standard 
promulgated before chrome compounds, the methylene chloride standard, 
began with a UAW petition.
    Without a doubt, these delays in the standard setting process have 
been aggravated by Congressionally imposed special reviews by ``small'' 
business
    employers [but not employees of small business], OMB imposed 
regulatory reviews, and increasing demands for detailed economic 
analyses. These have injected procedural Botox into an agency already 
paralyzed by analysis. But the delays are also attributable to the 
failure of OSHA and the Administration to support prompt action in 
promulgating additional standards.
    The legislative fix to this impasse has two parts. First, OSHA 
should be required to meet as high a threshold to defend refusing a 
petition for a new standard as it does to promulgate a new standard. 
Second, Congress should authorize OSHA to adopt the current Threshold 
Limit Values (TLV) list on a one time only basis. TLVs are developed by 
ACGIH, a group of scientists charged with investigating, recommending, 
and annually reviewing exposure limits for chemical substances. 
Generally, the TLV's are not as protective as permissible exposure 
limits set according to the OSHA law. Often the values allow a 
significant risk of material impairment to health, and don't push as 
far as would be economically feasible for the industry. In part, these 
shortcomings in protection arise from the nature of the ACGIH and its 
TLV committee, a set of volunteer organizations, with limited 
resources. ACGIH is not able to hold months of hearings, or hire 
specialized experts as OSHA might. But given OSHA's lack of action on 
setting new standards, the TLV's are a reasonable starting point in 
getting protection and future rulemaking. Congress should direct this 
action, not prevent this action. Where there is substantial objection 
to the limit for a particular agent, and a showing of material problems 
with compliance with that limit, OSHA should be compelled to place that 
agent in line for complete 6(b) rulemaking on a clear timetable.
    The UAW was able to negotiate with auto industry employers to 
establish the TLV's as the internal occupational exposure guidelines, 
with updating as needed. A limited but significant number of TLV's 
really make a difference. They establish exposure levels lower than 
those which prevail or may prevail in the industry. For example, the 
TLV for carbon monoxide is \1/2\ the OSHA permissible exposure limit, 
and this value can really drive improved ventilation in many industrial 
and service occupations.
    In conclusion, the UAW appreciates the opportunity to testify 
before this Subcommittee. We look forward to continuing to work with 
Congress and OSHA to improve the safety and health of all American 
workers. Thank you.
                                 ______
                                 
    Chairman Norwood. Thank you, Dr. Mirer.
    Henry, you are up.

              STATEMENT OF HENRY CHAJET, PARTNER,
                       PATTON BOGGS, LLP

    Mr. Chajet. Thank you, Mr. Chairman.
    Mr. Chairman and members of the committee, thank you for 
the opportunity to present testimony today on an issue of great 
importance to public policy in the United States and 
environmental and health and safety protections. We appreciate 
your leadership in this area and very much appreciate your help 
in making changes to solve a very significant problem.
    In the beginning, Mr. Chairman, you asked had things 
changed much since you held a hearing here 4 years ago. My 
answer to that question is yes. They have gotten worse. We saw 
a number of years ago a promise by the Department of Labor and 
the Department of HHS and ACGIH to work on this issue and make 
it better. What we have seen is substantial deterioration of 
the process.
    It is not just ACGIH either. It deals with other non-
consensus standard groups. For example, the International 
Agency for Research on Cancer, which is IARC, which is based in 
Europe and to whom we have delegated the power of the United 
States government to make decisions.
    That is what this is about. It is about the delegation or 
the illegal delegation of power to groups that are private or 
quasi-governmental, but they have no accountability to the 
citizens of our country or to you, the Members of Congress who 
pass these laws.
    You have given authority to OSHA, to EPA, to MSHA, to 
NIOSH, and that authority has been taken from those agencies 
and given to these groups that we call non-consensus standard 
organizations. That is a very polite term. It is a very polite 
term for an insidious, growing problem of giving away the power 
of the United States and the rights of its people, us, to seek 
review and input. Because when we work at these organizations 
that are non-consensus, what that really means is they meet in 
secret.
    What that really means is they don't tell us who the 
authors are of the product that they produce. They don't tell 
us what the conflicts of interest are or the bias, 
predetermined results. We don't even know the authors or the 
credentials of the people producing the material. It is that 
insidious growth of the giveaway of our rulemaking authority to 
these non-consensus groups that has brought us to where we are 
today.
    This is not about whether X number of milligrams of a 
substance or Y number of milligrams of a substance causes a 
health problem. We can't answer that question here today on any 
particular substance. But I can tell you one thing: The ACGIH 
makes no dispute over the fact that they regulate based on 
nuisance. If it makes you sneeze, if it makes your eyes appear 
like allergies, they regulate to try to stop that.
    And that is a worthy goal, but it is not what the OSH Act 
is all about. It is not what the EPA is all about. And because 
of that, we get these outrageous numbers by the bakers or other 
industries that they can't deal with these numbers, and they 
take away our competitiveness. This is a deceptive process. 
They take on the view that they are scientific, but in fact 
they produce junk science, and I use that term, Mr. Chairman, 
in a gratuitous way.
    I am trying to give them credit for something, but it is 
very difficult when you get into any one of the TLVs we have 
examined, and we have examined six of them in the last 5 years. 
It is very difficult to see any science at all. For example, we 
have authors who have said in testimony the data does not 
support the TLV, authors, the people that actually wrote it. We 
have authors who have said, ``I don't agree that we call that a 
human carcinogen,'' but there is the publication. We are stuck 
with it.
    We have authors who have said, ``Yes, I was the Federal 
employee in charge of that regulation, and I was also the ACGIH 
TLV author,'' with a direct conflict of interest. We know that 
the Federal Government is one of the largest funders of ACGIH 
and IARC. We don't know the extent of it. We know that there is 
$500,000 at least in publication purchases at ACGIH over the 
course of a couple of years.
    We see the conflicts of interest of people that are 
testifying in tort claims. The expert on vibration TLVs was the 
ACGIH author. The vibration TLV was rejected by his own agency, 
NIOSH. We see these conflicts repeated. We see the lack of 
science repeated in the six that we have identified, and yet 
there is no direct remedy other than suing them and trying to 
peel the onion in that manner.
    So we ask, Mr. Chairman, that you and the members of this 
committee and the Congress look at this problem, stop this 
illegal delegation of authority to these secret, non-consensus 
groups, and bring back the power to the agencies that you 
delegated this authority to.
    Thank you very much.
    [The prepared statement of Mr. Chajet follows:]

      Prepared Statement of Henry Chajet, Esq., Patton Boggs, LLP

    Mr. Chairman and Members of the Subcommittee, thank you for the 
opportunity to testify regarding the important policy and legal impacts 
of non-consensus organizations (NCOs) that create and adopt government 
sanctioned safety, health and environmental standards. These NCOs make 
``findings,'' create ``limits'' designate ``classifications,'' and 
establish ``guidelines,'' that are used for federal agency standard 
setting.
    The written testimony that I submitted for the record provides a 
summary and description, with documentary and testimonial evidence on 
an accompanying CD, of the secret, backdoor rulemaking conducted by one 
such NCO, the American Conference of Governmental Industrial Hygienists 
(``ACGIH''), and the junk science it has produced over the last ten 
years that is undermining the regulatory and legal system. Mr. 
Chairman, by using and supporting NCOs for standard setting, DOL, DOE, 
HHS, and EPA, are abrogating their duties through an insidious 
delegation of government authority that denies our fellow citizens the 
rights guaranteed by the Constitution and the protection of the laws 
enacted by the Congress.
    For example, unless the Secretary of Labor acts immediately to stop 
OSHA, the agency will improperly interpret its Hazard Communication 
Rule issued in 1987, to automatically incorporate into law an invalid 
2006 Threshold Limit Value?, or ``TLV'' limit, for silica, perhaps the 
most common mineral on earth and the basic component in glass, brick, 
concrete, stone, gravel and countless consumer and industrial products. 
The new TLV limit for silica is 1/4 the level deemed safe by valid OSHA 
and MSHA regulations and was created using secret authors with 
conflicts of interest and bias who ignored the scientific evidence that 
contradicts the TLV. The new TLV will have to be printed on material 
safety data sheets and become the basis of labels, warnings, and 
employee training. This will occur automatically, without any federal 
register notice or input from interested parties and without any of the 
protections of due process and appeal rights mandated by Congress. 
Later, some of my fellow members of the bar will call an expert witness 
to testify in product liability lawsuits, perhaps an ACGIH Committee 
member or the TLV author, who will describe the new silica TLV as the 
``standard of care'' sanctioned by the United States government, and 
claim that exceeding the TLV level causes harm.
    This is but one of many examples of how DOL, EPA, DOE and HHS 
continue to support, use, and rely on NCOs like the ACGIH. In contrast 
to NCOs, consensus organizations (e.g. ANSI), adopt standards according 
to strict procedures that are transparent, in open meetings, with a 
generous input and appeal process for all interested parties. The OSHA 
Act and other federal laws encourage agencies to use consensus 
standards, but unfortunately do not expressly prohibit their use of 
NCOs that, like ACGIH, adopt standards under a veil of secrecy. Unless 
you sue them, which I have done twice, it is impossible to discover the 
name of the author of a new limit, much less his or her credentials, 
bias and conflicts of interest, or the real reasons and basis for the 
limit. When you finally force NCOs like ACGIH to disclose their 
secrets, the results are shocking and demonstrate the real harm they 
cause: the encouragement and adoption of junk science by federal agency 
personnel that undermines the legal system in various ways, including:
    One: NCOs produce standards like the silica TLV limit using closed, 
secret procedures, often tainted by hidden conflicts of interest and 
bias.
    Two: NCOs like ACGIH do not use accepted scientific procedures such 
as outside, independent peer review and risk assessment, nor do they 
conduct independent research to support their standards. Yet, NCOs like 
ACGIH promote a false image of scientific integrity with the assistance 
of federal agency employees who participate in their standard setting 
and leadership.
    Three: US and foreign NCOs, like ACGIH and the International Agency 
for Research on Cancer (``IARC''), not only are provided with 
government credibility through the participation of senior federal 
employees, but they are also supported with taxpayer dollars that 
include direct funding, publication purchases, meeting registration 
payments and expenses, and the extensive use of federal employee time 
and agency resources.
    Four: To paraphrase one of the ACGIH's founders, NCOs like ACGIH 
provide a forum for agency employees to accomplish goals they could not 
otherwise accomplish in their official capacities.
    Five: NCOs provide credibility for select university researchers 
and give them access to federal employees that can assist them in 
obtaining government grants and resources.
    Six: Agencies misuse NCO standards to support rulemaking actions, 
to justify creating or lowering permissible exposure limits, or to 
impose regulatory requirements like air or medical monitoring or hazard 
communication. For instance, MSHA adopted a diesel exhaust standard in 
a rulemaking led by the agency official who secretly authored the 
corresponding diesel TLV. Similarly, MSHA issued a hazard communication 
rule that adopted the year 2000 TLV list, without disclosing that one 
its rulemaking leaders was the agency's secret official representative 
on the ACGIH TLV Committee. This year, DOE adopted all of the ACGIH's 
2005 TLV limits as enforceable standards for its contractors.
    ACGIH's clear conflicts of interest and bias on TLV limits are 
overwhelming. First, ACGIH has a marketing staff and sells TLV 
publications and meeting registrations for profit. OSHA, MSHA, and 
other federal officials that serve in ACGIH leadership roles make ACGIH 
purchasing and meeting registration decisions, help coordinate and plan 
ACGIH functions, and encourage agency personnel participation.
    Through litigation, agency personnel in ACGIH leadership positions 
have been ``caught'' simultaneously developing agency rules and ACGIH 
TLV limits on the same issue (e.g., diesel exhaust), using ACGIH to 
support and promote agency regulatory action (e.g., global 
harmonization and control banding), and using agency research to 
support ACGIH standards that their agencies would not adopt (e.g., 
vibration ergonomics TLV) or that could not survive legal rulemaking 
because of faulty science.
    TLV authors parlay their ACGIH roles into financial opportunities, 
including receiving federal research grants (e.g., TLV Committee 
Chairman), testifying as expert witnesses (e.g., vibration TLV author), 
and soliciting industry funding for their scientific research on 
pending TLV limits (e.g., copper).
    Though ACGIH claims it has changed its ways, instituted a conflict 
and bias prevention procedure, and uses sound science to base its TLV 
limits, these claims are a marketing deception. ACGIH officials 
testified that ACGIH does not identify, record on a written form, and 
review conflicts and bias, as claimed on its web site. In fact, ACGIH 
officials have testified that ACGIH ignores conflicts when they are 
reported to the ACGIH and that they personally should have been removed 
from TLV authorship, but were not. ACGIH officials have acknowledged 
under oath that they described the scientific data as not supporting 
the copper TLV they published, that they disagree with the silica TLV 
carcinogen designation, and that they based a TLV for a solvent on an 
isolated finding of a single, unpublished rat study that a panel of 
experts for the National Toxicology Program found was unreliable and 
should not be used. The following are examples of recent forced 
disclosures regarding ACGIH TLV limits:
     The primary author of the silica and arsine TLV limits is 
a private consultant on these issues. He participated in a California 
silica rulemaking, without disclosing his secret TLV authorship or 
conflicts. He admitted that his silica TLV coauthor is an example of 
someone who ``demonizes industry,'' and who had published an opinion 
that a reduced silica TLV should be adopted even before ACGIH reduced 
its TLV. The primary silica TLV author expressed his own disagreement 
with the ACGIH carcinogen classification for silica. He also admitted 
interpreting the scientific study upon which he based the new silica 
TLV limit in a manner inconsistent with the actual researcher who 
conducted the study, even though the study's research had complained to 
ACGIH about the misuse of the study.
     A senior MSHA employee authored the Diesel TLV even while 
he led the MSHA committee drafting the diesel rule and incorporated TLV 
materials in the rule. While DOL has announced new conflict prevention 
policies, no action has been taken to disclose and cure prior conflict-
infected actions.
     In spite of the new DOL policy, MSHA continues to secretly 
pay an official to serve on the TLV Committee. That official admitted 
working on the MSHA Hazard Communication Rule that adopted the year 
2000 TLV limits without disclosing her conflict to the public. In 
addition, MSHA approved her plaintiff's expert witness testimony, on a 
subject matter covered by the TLV Committee, while she was an MSHA 
employee and serving on the TLV committee as the MSHA representative.
     The TLV Committee Chair develops TLV limits for diesel 
particulate matter and beryllium, even while receiving millions of 
federal dollars to study these very substances. He admitted 
transferring the lead authorship for a TLV to avoid the appearance of a 
conflict, even though he remained involved in setting the TLV. He 
admitted being ``gifted'' valuable federal property--genetically 
altered animals for research by his organization (NYU) on pending TLV 
limits.
     The Copper TLV author did not recuse herself from 
developing that TLV even though she also sought private funding for 
copper research from industry. While she reported the conflict to 
ACGIH, she did not know why they did not remove her from the authorship 
and preferred that they would have done so.
     The author for the vibration TLV (an ergonomics TLV), 
served as an official NIOSH representative to the TLV Committee and has 
been a plaintiff's expert witness in 14 product liability cases 
claiming that hand tools are defective. He relies on his interpretation 
of the TLV he drafted, which NIOSH rejected, and which uses a single 
measurement for one minute to reflect a full day of vibration exposure, 
regardless of significantly lower measurements taken on the same day by 
him.
    Given these and other conflicts and bias, it should be no surprise 
that these TLV limits are junk science. Moreover, there are no 
qualifications required to draft TLV limits. The author of the Copper 
TLV limit does not even have experience in industrial hygiene. Her TLV 
training amounted to a ``power point presentation.'' The recent ACGIH 
Chairperson, who's also an OSHA regional administrator, described all 
of the types of medical and scientific expertise needed to create an 
exposure limit, admitted she did not have any of them, but contended 
that she required none of them to adopt TLV limits as the Chair of the 
ACGIH Board of Directors.
    The TLV limits described above are arbitrary. The proposed 
Beryllium TLV limit changed by orders of magnitude several times in two 
years, without any new data or studies to justify the changes. One 
author admitted under oath that she simply gives ``less priority'' to 
studies that support higher exposure limits. The Copper TLV author 
admitted that because she missed the final committee meeting, she 
wrote, and ACGIH published, a different TLV than the committee voted to 
adopt. The Silica TLV likewise relies on incorrect literature and 
studies, including a discredited study involving defective lab 
equipment. The Silica TLV author even admits that in his opinion, 
silica is not a suspected human carcinogen, contrary to the ACGIH 
classification.
    TLV authors do not search comprehensively for relevant scientific 
studies when writing a TLV. The Silica TLV author did not even read 
literature cited in his TLV documentation as support for his TLV. TLV 
authors don't review or consult other ACGIH publications, committees, 
or committee members, leading the Beryllium TLV to rely heavily on a 
blood test which another ACGIH committee deemed ineffective and 
infeasible. Similarly, one of OSHA's senior officials, Richard Fairfax, 
rejected the copper TLV as not supported by the evidence when he served 
as chairman of a TLV subcommittee and author of that TLV. The same TLV 
limit, based on the same invalid evidence, was proposed again by the 
current author, and published by ACGIH, without even knowing it had 
already been rejected by ACGIH itself due to the invalidity of its 
scientific basis.
    ACGIH TLV authors do not consider, or even read, scientific 
comments submitted to ACGIH by industry and other interested parties. 
Thus, when the Silica TLV author misinterpreted a key study and the 
author of that study wrote and complained to ACGIH, the TLV author 
simply ignored the complaint. When the National Mining Association 
submitted comments to ACGIH on the proposed Copper TLV, they were not 
read by the TLV author. TLV limits also are not peer reviewed, even 
when specifically requested by TLV Committee members. The ACGIH TLV 
Chairman admitted that his request for the use of outside peer 
reviewers was rejected, and the Beryllium and Copper TLV author 
admitted that no scientific journal would publish her TLVs.
    After being developed in secret by anonymous authors, TLVs are 
adopted with almost no further review within ACGIH. At one meeting in 
2004, the ACGIH Board adopted 60 TLV recommendations at once, spending 
an average four to five minutes considering each. One former TLV 
Committee member wrote that ``[t]here are just too many things to read 
in real life to let me spend time for a critical review.''
    Worse yet, the federal agencies financially support ACGIH, 
influence TLV limits, and improperly adopt and rely on them without any 
review of their scientific validity. One computer report shows over 
$500,000 in federal purchases of ACGIH products over a recent 3-year 
period. Another invoice shows over $54,000 in ACGIH purchases by just 
one OSHA regional office in one year.
    A founder of ACGIH once said that an organization like ACGIH ``can 
very often accomplish things which an organization of more official 
character is unable to do * * * * even though the same people are 
talking.'' Indeed, ACGIH's lawyers admitted that TLV limits are used by 
government as ``de facto standards'' when the proper rulemaking process 
becomes ``bogged down.'' The Justice Department has admitted that 
federal agency employees serve on ACGIH TLV committees both in their 
``official'' and un-official personal capacities, even though ACGIH 
deceptively advertises that its ``volunteers'' serve only in their 
personal capacity.
    Conclusion
    Mr. Chairman, ACGIH was once a legitimate creation of the federal 
government, managed and housed by the Public Health Service and NIOSH. 
It benefited the public by the adoption of TLV limits by its full 
membership, in an open, transparent and consensus process. 
Unfortunately, today the ACGIH is different. It has transformed into a 
rogue advisory committee; a hollow, secretive organization through 
which individuals with conflicts of interest change federal standards 
based on junk science. This NCO backdoor rulemaking violates federal 
law and results in de facto standards which bear little resemblance to 
the latest scientific knowledge necessary to protect workers and the 
environment.
    Mr. Chairman, I thank you for the opportunity to testify and for 
your efforts to focus sunshine on this issue and encourage sound 
science and accountability in government. As a result of this 
Subcommittee's hearings and a federal lawsuit five years ago, DOL, HHS 
and ACGIH promised reforms, after ACGIH withdrew its TLV limit for 
trona in a published apology that announced to the world there were no 
health effects to support the TLV limit. I regret to report, however, 
that the reforms never arrived, and instead the situation has 
deteriorated even further. I hope this hearing will spur meaningful 
change and I look forward to working with you to help restore the 
integrity of our regulatory system.
                                 ______
                                 
    Chairman Norwood. Thank you for your testimony.
    I think it is important to make it very clear that this 
chairman doesn't really care what the TLV is. I don't care what 
the PEL is. Whatever number is the correct scientific number, I 
am all for.
    What I don't like that I see going on out there is that we 
are not following the law in determining that, and our great 
OSHA has been, and I have been at them for a number of years, 
trying to say to them, we need to produce new PELs in the 21st 
century. We really need to get some new threshold information 
and values in the 21st century, but we need to do it according 
to the law.
    All advisory committees, standing or ad hoc, must have 
members representing management, labor, state agencies, as well 
as one or more designees of the secretary of HHS. Now, that is 
who should come together to determine what a TLV is. I don't 
think the way we are doing it now in secret is going to 
continue. I hope not. I am going to try to stop it.
    And that is what this hearing is about, not that we don't 
need to improve our PELs greatly, because I know we do too. And 
I have tried on more than a few occasions actually to get some 
consensus out there and it is pretty hard to do and in the end 
it may well have to be Congress that once again demands we do 
it a certain way in order to get these PELs improved. But they 
have got to be proved in the sunlight where everybody gets some 
input.
    Dr. Mirer said, well, now it is just two people coming 
together deciding and fighting back and forth about it, meaning 
I guess small business people who are concerned that these new 
standards are affecting their business fighting with whom. 
Well, the only people he can fight with about it are OSHA. You 
certainly can't fight anything with industrial hygienists who 
don't know what they have done. Nobody has any way of finding 
it out.
    And also, Mr. Chajet, I want to ask you about this business 
that OSHA is not fighting employers' failure to comply with 
TLVs that are set by the governmental industrial hygienists, 
not specifically, not under the general duty clause. I am 
asking you, has this been your experience that OSHA takes TLVs 
from this secret organization and uses the general duty clause 
or not?
    Mr. Chajet. Mr. Chairman, we have seen examples of that. I 
think there is a much bigger problem and that is that OSHA 
forces employers to spend millions of dollars to change 
material safety data sheets every year when the ACGIH changes 
its list, and then they will cite you for having a material 
safety data sheet that doesn't have the TLV listed on there.
    Chairman Norwood. What authority could you possibly tell me 
OSHA has to do that?
    Mr. Chajet. Mr. Chairman, they interpret their hazard 
communication rule that was adopted in 1987 to adopt a 2006 TLV 
developed by ACGIH, and how they interpret it that way, I can't 
explain. I think it is wrong. I think it is illegal. I think it 
is inappropriate, but yet that is what they do.
    Chairman Norwood. They can't do it. It is not allowable for 
to use non-consensus standard-setting organizations. There is 
no where in the OSH Act that says that. It is very clear in the 
OSH Act that you have to use consensus standards. Tell me how 
they get away with breaking the law?
    Mr. Chajet. Mr. Chairman, I taught occupational safety and 
health law at Johns Hopkins graduate school of public health 
for more than 15 years. I have read that law thousands of 
times. I have to tell you, they have to give notice. They have 
to have public input. They have to have rulemaking and I don't 
understand how they can adopt the 2006 list or the 2005 list or 
the 2004 list every year over and over again without complying 
with the law.
    They don't comply with the Federal Register Act, which says 
publish it in the Federal Register. They don't comply with the 
Federal Advisory Committee Act, which says when you are using a 
group like this that is advisory you have to comply with these 
procedures. They don't comply with any of it.
    Dr. Mirer. Dr. Norwood, do you want an answer to this 
question, or his fabrications?
    Chairman Norwood. You go ahead.
    Dr. Mirer. OK. The communications standard which was 
adopted during the Reagan administration, I might add, has been 
in place for near 30 years now. It is a standard that requires 
the chemical supplier to disclose what they know about the 
hazards of a chemical. They are also entitled to argue against 
that, but they have to disclose what they know about the 
hazards of the chemicals.
    Chairman Norwood. Disclose to who?
    Dr. Mirer. To the person they are selling the chemical to, 
who in turn has to disclose it to their employees.
    Chairman Norwood. Right. They have to have a written 
document that does that.
    Dr. Mirer. So to help the employer help the chemical 
supplier, OSHA specified at that time the kinds of information 
that ought to be included in it, and that included the ACGIH 
TLV. What we are talking about----
    Chairman Norwood. But OSHA doesn't have any authority to do 
that.
    Dr. Mirer. Well, it is something that has been in place 
since 1987.
    Chairman Norwood. That doesn't make it right at all. That 
is what we are talking about here now, what is right and what 
is wrong, not about whether we have had----
    Dr. Mirer. That standard was litigated through the appeals 
courts many times. This issue never came up before, and it has 
been invented now, but that standard has been well reviewed 
judicially.
    Chairman Norwood. Depending upon the definition of 
``consensus,'' again please. It is in the OSH Act.
    Dr. Mirer. The consensus standard provisions there talk 
about the adoption of consensus standards during the initial 
period of OSHA. This is not adopting a consensus standard. It 
is requiring the employer, the chemical company to disclose 
what they know about the hazards of the chemical.
    A review paper like a documentation for the TLVs or the TLV 
itself is information about the hazards of the chemical which 
only at their peril would any employer ignore, and only at 
their peril would any employer conceal that information.
    Chairman Norwood. Which has what to do with the government 
hygienists?
    Dr. Mirer. I am sorry?
    Chairman Norwood. What does this have to do with the 
governmental hygienists, industrial hygienists? What has this 
got to do with that organization?
    Dr. Mirer. The governmental industrial hygienists' 
documentation for the TLV and the TLV itself are very 
substantial, heavily reviewed for the compilation reviewed by 
OSHA.
    Chairman Norwood. But they are used by OSHA and they are 
non-consensus.
    Let me give Mr. Chajet an opportunity. You have impugned 
his reputation a little bit. Let me give him a minute to 
respond.
    Mr. Chajet. Thank you, Mr. Chairman.
    Part of the problem is that my good friend Frank is 
thinking about the ACGIH the way it was 20 years ago, when it 
was an open process, when they were respected for good science, 
when they sought out his opinion, the opinion of industry 
professionals, the opinion of people that used the materials.
    That has changed. That has changed because they closed the 
meetings, because they took the vote away from their 
membership. And yet this group still has that brand that made 
Frank and others think this is a great thing. But it is not.
    Let me give you an example. The documentation that Frank is 
talking about that they put on the street and they asked people 
to believe is sound science, it is that documentation that when 
you peel the onion, you find out that it had one author and 
didn't get reviewed by anybody. The rest of the board didn't 
read it before they voted on it. They adopted 60 of them and 
they spent 4 1/2 to 5 minutes on each one in a half-day 
meeting.
    This is the process. It is a secret author. And then when 
you ask the author, right, we have one documentation where the 
author said, ``yes, I relied on this particular study that 
involved rats.'' Did you look at the human studies? ``No.'' And 
then you ask the author, well, that particular study that 
involved rats, did you know that the national toxicology 
program said it was a bad study? He said, ``yes, but I relied 
on it anyway.''
    And then you get a TLV. So Frank's image of what this 
process is about is different than the reality.
    Chairman Norwood. We are not going to get consensus, I can 
tell. It is Mr. Owens time. You are recognized for whatever 
time you need.
    Mr. Owens. Mr. Chajet, would you say ACGIH is a 
racketeering enterprise or a communist conspiracy? Why do they 
do what they do? And what motivation would they have to do be a 
fraudulent organization, perpetrating misinformation?
    Mr. Chajet. Congressman, I wouldn't use those words, but 
they are an interesting concept. This organization is motivated 
by the motivations of its individual people. So you have one 
person, for example, who is working at the Mine Safety and 
Health Administration trying to get a regulation passed, and he 
is the author of the diesel regulation. And then he goes to 
ACGIH and he writes the diesel TLV. And then they use one to 
bootstrap the other. That is one motivation.
    The other motivation is you have a ACGIH TLV author, and 
then he leaves the ACGIH and become a union expert witness on 
vibration, and he testifies and he makes thousands upon 
thousands of dollars to testify that if you violate this 
particular number, that tool will cause you harm. And then you 
know what happens in those court cases.
    Mr. Owens. So are you saying that there are some payoffs 
and kickbacks and some financial remuneration involved here? 
Either that, or somebody is trying to undermine the nation?
    Mr. Chajet. Congressman, there are direct conflicts of 
interest within that organization, and I have already provided 
background material to the committee which I would ask be 
introduced into the record, if that is possible.*
---------------------------------------------------------------------------
    *Submitted and placed in permanent archive file, testimony before 
the United States House of Representatives, Committee on Education and 
the Workforce, Subcommittee on Workforce Protections, Henry Chajet, 
ESQ., Patton Boggs LLP, Washington, DC (April 27, 2006).
---------------------------------------------------------------------------
    Mr. Owens. Do you think the American Dental Association 
would fall in the same category?
    Mr. Chajet. I am sorry? I didn't hear you.
    Mr. Owens. Do you think the American Dental Association 
would fall in the same category?
    Mr. Chajet. I still didn't----
    Mr. Owens. The American Dental Association.
    Chairman Norwood. My organization, the American Dental 
Association.
    Mr. Chajet. I think that is the best organization in 
America.
    [Laughter.]
    Mr. Owens. Thank you. I want to change the subject a bit.
    Mr. Ruddell, I understand from looking at the MSHA website 
that a mineworker was killed on the job just 5 days ago at 
Franklin Industrial Minerals' Anderson mine in Tennessee. You 
didn't mention that in your testimony.
    Have you had any communications about this? As director of 
environmental safety for Franklin Industrial Minerals, what 
steps would you take to prevent similar work events at your 
mines?
    Mr. Ruddell. That situation is still under investigation, 
sir, and you are correct that we did recently have a fatality 
at one of our operations, and MSHA is thoroughly investigating 
it, along with us.
    Mr. Owens. In view of the fact that we are talking about 
Workers Memorial Day tomorrow, any steps you would take to 
prevent similar kinds of things? You don't know anything about 
it at this point?
    Mr. Ruddell. No, I am familiar with it, but we are under 
investigation. I can get back to you on more details, but right 
now the investigation is ongoing and I don't have any specific 
answers for it, but I can get back to you.
    Mr. Owens. We obtained that information from an MSHA 
bulletin, a report from MSHA. Do you get that information as 
rapidly?
    Mr. Ruddell. I haven't seen it, so I really can't comment 
on it right now. But again, I would be happy to look at it and 
get back to you on it.
    Mr. Owens. Dr. Mirer, let's talk about relevant steps to 
protect workers in terms of the most important chemicals on the 
TLV list. Let's assume that there is a process going on out 
there that really wants to protect workers, that doesn't have 
some dark motives, is not a racketeering enterprise.
    What should OSHA be doing to protect workers before these 
standards are set? We have chemicals coming on-line all the 
time, about 500 on the TLV list. Which are the most important 
for OSHA to move forward on?
    Dr. Mirer. In the straightforward process that we actually 
started after the chairman's last hearing on this question, we 
attempted to set forward a consensus group that would make 
priorities for OSHA to move forward with rapid adoption. Part 
of the discussion there was what would happen where there were 
chemicals of substantial impact, like silica, like carbon 
monoxide, where the standards are clearly inadequate based on 
hundreds of studies of silica and many on carbon monoxide.
    What would be the process after that? The process after 
that would be some trigger of OSHA doing rule 6(b) rulemaking, 
bound by a particular time. So you have a two-stage process. 
You make the priorities and you go forward.
    In the interval, those situations which meet the definition 
of the general duty clause, that is to say, has the hazard been 
recognized generally in the employer's industry. In those 
situations, the employer has the obligation to abate the 
hazard, whether or not there is a TLV. The TLV is only part of 
the evidence to why there might be, and we could go forward 
with that.
    For many of these situations, there are, as in the TRW 
situation, there are actual workers getting sick in the 
workplace. There are workers bringing these problems to the 
attention of the employer. There are unions and representatives 
of workers bringing these problems to the employer.
    What we don't need is OSHA coming around and saying it is 
in compliance with the standard. As at the World Trade Center, 
we don't need OSHA coming around telling the employer they are 
in compliance with the standard and we have nothing to enforce. 
Even if we were enforcing, we would still have nothing to 
enforce in this situation. That is what we don't need.
    We need to get OSHA out of that particular framework. If 
they are not moving forward with standards, I don't know what 
we are going to do or what we can accomplish.
    Mr. Owens. Just one final question to Mr. Ruddell. I 
happened to be watching the History Channel last night, and 
Marvels was dealing with your industry, a fantastic, huge, 
magnificent industry. It makes a lot of money.
    I just wondered, for both you and Ms. Marcucci, are we 
talking about high costs? Somebody has implied that the TLVs 
are just nuisances, that really they are not important. 
Sneezing is not a symptom of something more serious. These TLVs 
that we are talking about are being in the way.
    Do they cause your industry, do they cost a great deal if 
you were to pay more attention to these TLVs and their impact 
on workers' health?
    Ms. Marcucci. For the baking industry, it would cost 
approximately $500,000 to put in the equipment to lower the 
TLVs.
    Mr. Owens. A half-million for the whole nation?
    Ms. Marcucci. I am sorry?
    Mr. Owens. A half-million for the bakeries across the whole 
nation?
    Ms. Marcucci. For every bakery.
    Mr. Owens. Each bakery would have to pay $500,000?
    Ms. Marcucci. We would have to put a half-million dollars 
worth of equipment into the baking facility or the equipment 
used to protect the employees. It would be dust collectors and 
face masks, et cetera, so approximately $500,000 to be utilized 
in the bake shop.
    Mr. Owens. This is for Pepperidge Farm or one of the big 
bakeries?
    Ms. Marcucci. My small bakery would be approximately a 
half-million dollars for this equipment, to purchase it and to 
retrofit it to our existing equipment.
    Mr. Owens. That is your estimate? How many workers do you 
have?
    Ms. Marcucci. We have 350.
    Mr. Owens. Oh, 350 workers.
    Mr. Ruddell?
    Mr. Ruddell. Right now, I don't have exact numbers on what 
it would cost on some of the TLVs that have been proposed. We 
do have best available control technology for dust in our 
facilities. We actually sell dust as a product, so we try to 
recoup all of it, get all of it we can. So I am sorry. I can 
get back to you if you want, but I do not have a specific 
dollar figure for what it would cost us to comply with lower 
TLVs.
    Mr. Owens. Well, it pays to keep the dust out of the lungs 
of the workers, because you can sell it. Right?
    Mr. Ruddell. Well, what comes first is safety. For us to 
stay in business, the health and safety of our workers is No. 
1. We do everything we can to protect our workers. We have 
standards set so that we know what targets we have to shoot 
for. We try to always be below those TLVs, whether they are set 
by AGCIH or whomever. But as far as a specific number, the 
biggest concern we have is the setting of the standards by 
inference, by reference, rather than going through the process. 
That is the main reason I am here.
    Mr. Owens. But generally, paying attention to the TLVs is 
good business.
    Mr. Ruddell. Yes.
    Mr. Owens. Thank you.
    Mr. Ruddell. We use them as a basis.
    Mr. Owens. Thank you.
    Thank you, Mr. Chairman.
    Chairman Norwood. Yes, sir.
    Mr. Kline, you are recognized.
    Mr. Kline. Thank you, Mr. Chairman.
    Thank you, lady and gentlemen for appearing before us 
today. It is some very fascinating testimony. I have to admit 
that I have learned an awful lot, that my level of knowledge 
and understanding was even lower than I thought when we started 
this, so it has been very helpful.
    It is also interesting to have one witness accusing another 
of fabricating testimony. That is a little unusual for us, too, 
so it has been kind of an exciting day.
    Mr. Chajet, let me come back to you, if I could. I have 
some notes here that, frankly, the staff has prepared, but they 
are interesting questions and I would like to pursue them if I 
could.
    Your testimony suggests a pretty large expenditure of 
Federal dollars on ACGIH materials and conference. Do you have 
any idea how much? Can you kind of give us a sense for what is 
involved there?
    Mr. Chajet. Congressman, I will try to get those numbers. I 
have asked. I have sent requests. It is nearly impossible for 
me to get those numbers. We have two pieces of paper that I am 
happy to share with you. One is a printout and it came from 
ACGIH that looks like about $540,000 for books over the course 
of a couple of years. It is old.
    I also have another piece of paper that is $54,000 purchase 
order for books from one local OSHA office in 1 year. Those are 
the only real pieces of evidence I have on how much they are 
spending. But I can tell you that the Federal agencies are 
supporting and giving credibility to these organizations, not 
just with resources and dollars and money, but with time.
    The chairperson of the ACGIH for the last 2 years has been 
the OSHA regional administrator in Atlanta, Georgia. When you 
try to find out how that time is allocated and whether it is 
Federal payroll time or whether it is ACGIH time, they go to a 
meeting; 2 hours is ACGIH time and the next 6 hours it is OSHA 
business.
    So I can't really give you an idea of the reality of it, 
but I can tell you I think it is the largest source of income 
of ACGIH and IARC.
    Mr. Kline. OK. So we are lacking documentation. The staff 
just gave me something here that is an order for supplies or 
services, but I can see that that trying to get to the bottom 
of that would be something this committee ought to involve 
itself in.
    Lawsuits are always a matter of some interest, and I would 
say concern to me. Your testimony again references some 
lawsuits that have relied on these TLVs. Can you expand on that 
a little bit in the few minutes I have here?
    Mr. Chajet. Congressman, I don't know how many hundreds or 
thousands of lawsuits the TLVs have been introduced into. But I 
can tell you that one great example is the TLVs for vibration, 
which NIOSH rejected because they couldn't really member the 
dose.
    The vibration changes all the time when you are putting 
your drill against hard wood or soft wood, and they can't 
really measure the effect either, but yet there is a TLV for 
it. The person that wrote that TLV, or claims to have written 
it, as the ACGIH committee member testified 14 times for 
plaintiffs.
    How many times has that happened? I know that particular 
event has probably happened hundreds or maybe thousands of 
times.
    Mr. Kline. OK. Thank you.
    I yield back, Mr. Chairman.
    Chairman Norwood. Thank you.
    Mr. Owens. Mr. Chairman, I want to ask permission to submit 
additional questions to our witnesses in writing for the 
record.
    Chairman Norwood. In writing? OK. Certainly, so ordered.
    I have a couple of questions and I will be ready to 
summarize and close. Mr. Owens, do you wish to do the same? You 
will do yours in writing?
    Mr. Owens. Yes.
    Chairman Norwood. Ladies and gentlemen, we will submit in 
writing and would greatly appreciate your prompt response, if 
you would. But I still have a couple of things I need to get 
off my back a little bit.
    Liz, I know that there has been a lot of money spent by the 
American Bakers Association. I am of the studies that you have 
gone out and done in your organization. I don't know how much. 
Do you know how much the association has spent on trying to get 
good studies on actually what the peril ought to be in terms of 
flour?
    Ms. Marcucci. Yes, Mr. Chairman. The first study cost us 
approximately $40,000, and we have just recently received a 
quote to update the program again for about half that cost.
    Chairman Norwood. Now, my question is, do you think we 
could have gotten to an acceptable TLV with good science, that 
everybody could have agreed on? Because I agree with Mr. 
Ruddell, his answer to Mr. Owens, it is very important to pay 
attention to these threshold limit values, for your own sake 
and your own company's good. But why couldn't we come to some 
consensus on a TLV? Or was it done in private where you had 
absolutely no way of having any thoughts on the matter or any 
input?
    Ms. Marcucci. As I mentioned in my testimony, Mr. Chairman, 
we were not given any of that information, and we were not 
given the opportunity to have open discussion about TLVs. Of 
course, we want TLVs in place to protect our employees, and we 
will use the resources necessary to protect our employees. But 
we request the opportunity to be able to have open dialog with 
ACGIH and other groups that are setting these standards.
    Chairman Norwood. Well, if they were to set the standard, 
well, they did set the standard, do any of us know what science 
they used or what science they do as an association to 
determine the standard?
    You get to go next. Yes, I am asking you. Where do they get 
their scientific material or do they produce any scientific 
material?
    Ms. Marcucci. Mr. Chairman, I am not aware of where they 
get their material. We were not given any information. If you 
look at my written statement that was handed in, it explains 
that we requested many times that information and were given 
nothing.
    Chairman Norwood. So you are living with a threshold limit 
value of which somebody out there says this is good science, 
but Lord knows you can't know who?
    Ms. Marcucci. Correct.
    Chairman Norwood. Dr. Mirer?
    Dr. Mirer. The documentation for the TLV, which is a review 
of all the science and an explanation for why they chose to set 
the standard where it is----
    Chairman Norwood. Excuse me. May I interrupt? A review of--
they review the literature? That is all they do?
    Dr. Mirer. It is a review of the scientific--yes.
    Chairman Norwood. All they do is look at other people's 
work?
    Dr. Mirer. What do you mean ``all they do''? They review 
the scientific literature. And then OSHA reviews the scientific 
literature.
    Chairman Norwood. Do they do any science themselves? Do 
they actually study any of it themselves? Or do they look at a 
program done in Germany that nobody believes in anyway, but 
none of us can know they looked at it?
    Dr. Mirer. Well, first of all, you do know they looked at 
it because they publish in advance with the notice of any 
changes----
    Chairman Norwood. I don't know any of that.
    Dr. Mirer. They publish the documentation for the TLV, 
which states each piece of information that they used to set 
the standard and the logic connecting to it. No, they do not 
themselves do the research. Neither does OSHA do any research 
itself to support the scientific literature that is there.
    Second, they do accept, and I have written those comments 
myself, they do accept comments from anybody and they are 
reviewed in the TLV committee.
    Chairman Norwood. Does anybody in here agree with that? 
That the government industrial hygienists accept anything from 
anybody?
    Dr. Mirer. Yes.
    Chairman Norwood. I am asking the other three.
    Mr. Chajet. Mr. Chairman, I can tell you that the author of 
the copper limit and ACGIH said under oath that she did not 
read the comments that were submitted. So whether you submit 
them or not doesn't matter. They don't read them.
    Other authors have said, yes, we cite that literature, but 
we didn't read it. This is a very difficult process because you 
don't get to find that out until you sue them. People like 
Frank believe it is a scientific process, but it is not.
    Chairman Norwood. Let me go back to Liz. She was not quite 
through, but I did want to give you a shot into that.
    Liz, finish up.
    Ms. Marcucci. Thank you, Mr. Chairman.
    The purpose of the SOMA study was to check ACGIH's facts 
and science. SOMA totally dismissed ACGIH's science that this 
was based on, that the TLVs were based on.
    Chairman Norwood. So take it a step further. We have a non-
consensus standard-setting organization that has supposedly 
nothing to do with the government, writing standards that the 
government is accepting, and nobody can know anything about it, 
and this gets more complex because states see OSHA accepting it 
and what happens in the states?
    Ms. Marcucci. From my presentation that I gave, we have had 
bakeries that have received OSHA violations by state-run plans 
for not following or not being within the ACGIH standards. So 
they were documenting the flour dust levels against ACGIH 
standards, which would not be correct.
    Chairman Norwood. So standards around the nation, then, are 
dictating to companies around the Nation what their threshold 
limits ought to be, and it is done by people none of us know 
who don't work for the government, and the Labor Department is 
complicit in this illegal act.
    Ms. Marcucci. Correct, Mr. Chairman.
    Chairman Norwood. Did you get that?
    Dr. Mirer. Can I correct one thing? We do know who writes 
them because the members of the TLV committee and consultants 
who participate in it are published in the book that they 
publish every year.
    The scientific comments come into the secretariat and are 
distributed to the TLV committee members and they do not 
disclose who is working on any particular material, although 
the current rules require that the person working on the 
material have no interest in it, whether it is a conflict of 
interest or just an intellectual interest in the industry that 
they are working on. But they do know who wrote them.
    Chairman Norwood. Do they not want us to know that they are 
being paid by the taxpayers during daylight? Do they not want 
us to know they work for OSHA?
    Dr. Mirer. They disclose the employer of everybody who is 
working on it.
    Chairman Norwood. So they don't mind us knowing they work 
for OSHA?
    Dr. Mirer. They fully disclose who everybody is working 
for.
    Chairman Norwood. So in daytime the taxpayers pay them at 
OSHA and at nighttime they go over to this organization and 
secretly write standards the rest of us have to live with, and 
then take them back over there and sit at the same desk and 
say, boy, this is a great standard. My buddy over there wrote 
it. I know it is the way to go.
    And none of us get any input at all, which is against the 
OSH Act. I don't care what haz-com has to say in their 
regulation. That is not in the OSH Act. I care about the fact 
that OSH Act says consensus standards. And that is not what is 
happening.
    And let me just conclude by saying there is a serious 
problem when these very same people who work for OSHA, the 
Labor Department, go over at night and write these standards 
that nobody gets any input to, and then the rest of us 
taxpayers get to pay them for it.
    Now, we don't know how much is being paid yet. We do know 
there is a case in New England where $65,000 bought some of 
their books, but I am going to find out exactly how much the 
taxpayers are paying this non-government agency that is 
breaking the law. We are going to find it out, and they are 
going to stop.
    Second, I agree with you that the PELs have to be updated. 
We couldn't get labor and business to decide on whether the 
table was round or square. Now, I tried very hard to get 
grownups to sit down and be reasonable about changing these 
PELs because you are right, they do need to be updated. I don't 
think there is anybody in this room who doesn't know that. 
Maybe Congress needs to act and do that if I can't get you all 
to sit down and work this out.
    But the American governmental industrial hygienists are 
going to stop writing the laws of this land if it is the last 
thing I do on this earth. They better get ready because I am 
going to come after them, and I am going to keep coming after 
them, and you guys over at OSHA and the Labor Department that 
are letting this happen are next on that podium.
    Under oath, we are going to find out why you are allowing 
this to happen. It is not tricking anybody, and it is 
absolutely against what Congress wants to happen. You are a 
Federal agency; supposedly you are supposed to enforce the law. 
Quit writing it. That is what you are trying to do and that is 
what you are letting happen.
    Now, I hope you are writing it down, Steve, because we 
tried to fix this. Senator Enzi tried to fix this, and the 
Labor Department stopped it, and it is now war.
    Thank you all for coming.
    Excuse my tirade, but I do get enough after a while.
    Your time has been greatly appreciated.
    And this meeting is now adjourned.
    [Whereupon, at 11:54 a.m., the subcommittee was adjourned.]
    [Additional materials submitted for the record follow:]

   Letter Submitted by the National Ready Mixed Concrete Association

                                                       May 5, 2006.
Hon. Charles W. Norwood,
Chairman, Subcommittee on Workforce Protections, Committee on Education 
        and the Workforce, Rayburn House Office Building, Washington, 
        DC.
    Dear Chairman Norwood: The National Ready Mixed Concrete 
Association (NRMCA) welcomes the opportunity to submit a statement 
about the important work that the House Workforce Protections 
Subcommittee is undertaking to deal with the issue of non-consensus 
health standards. NRMCA represents one thousand three hundred ready 
mixed concrete companies that employ seventy thousand men and women 
living and working in every congressional district in the United States 
and its territories.
    Protecting employee health and safety is of paramount importance to 
NRMCA and its member companies. To achieve this objective, 
organizations must conduct work in an open environment, thereby 
ensuring that interested parties have an opportunity to voice comment 
and to provide expertise as the case may be. The current process in 
which the American Conference of Governmental Industrial Hygienists 
(ACGIH) sets threshold limit values (TLV) does not allow input from the 
public. The lack of public input into the ACGIH standards setting 
process combined with Occupational Safety and Health Administration 
(OSHA) personnel having input into the ACGIH process is cause for 
concern. Only by considering all relevant information contributed by 
all interested parties can the most protective measures for employee 
health be determined. NRMCA does not believe that the current process 
allows for such consideration to occur.
    NRMCA asks that the Subcommittee on Workforce Protections delve 
into this matter more thoroughly to ascertain how the most appropriate 
and protective TLVs and PELs can be determined. NRMCA believes that 
deliberation of all relevant data on the issue of employee health 
protection must occur to achieve the best work environment for 
employees in ready mixed concrete manufacturing.
            Very truly yours,
                                     Thomas V. Harman, CSP,
                                         Government Affairs, NRMCA.
                                 ______
                                 

     Prepared Statement of the Independent Lubricant Manufacturers 
                              Association

    The Independent Lubricant Manufacturers Association (ILMA) submits 
this statement for inclusion in the record of the Subcommittee on 
Workforce Protection's April 27, 2006 hearing, examining the use of 
non-consensus standards in workplace health and safety. The Association 
appreciates this opportunity to share its views on this matter with the 
Members of the Subcommittee.
Executive Summary
    Protecting worker health and safety at the national level through 
regulation is a daunting task. Over the years, federal agencies have 
wisely looked to the private sector to help do the job properly. To 
assist federal agencies better leverage the energy and know-how of the 
private sector, Congress passed the ``National Technology Transfer and 
Advancement Act of 1995'' (NTTAA). Pursuant to the NTTAA, as 
supplemented by OMB Circular A-119, federal administrative agencies are 
directed to take into account privately developed consensus standards 
that relate to their regulatory activities. For a standard to be 
consensus, the development process must have the following attributes: 
(1) openness; (2) balance of interests; (3) due process; and, (4) an 
appeals process.
    While the reliance on consensus standards typically enhances the 
regulatory efforts of federal agencies, the use of non-consensus 
standards can hinder, confuse and, in some cases, damage such efforts. 
The process that creates non-consensus standards often generates 
inferior and possibly defective information. Premising regulatory 
action on such inferior or defective information is not unlike building 
a house at a choice location using the finest materials, but neglecting 
to first lay a foundation. Without a solid foundation, a stylish new 
home is expensive in the short term, and ultimately useless in the long 
term.
    The American Council of Government Industrial Hygienists (ACGIH) 
recently developed a Threshold Value Limit (TLV) for ``Mineral Oil Used 
in Metal Working.'' This TLV is a non-consensus standard. Because it 
was developed in a closed, secretive process, ILMA asserts that it 
contains a number of conceptual and measurement defects.
    Notwithstanding the presence of these defects, the Occupational 
Safety and Health Administration (OSHA) is poised to incorporate by 
reference the TLV once it becomes finalized by ACGIH. Once incorporated 
by reference, this TLV will instantly have legal status under OSHA 
regulations and may be the foundation of enforcement decisions made by 
OSHA and other administrative agencies. The defects in this TLV will 
undermine any subsequent regulatory action premised on the TLV.
    The fact that OSHA has incorporated non-consensus standards into 
its regulatory programs for years is somewhat curious in and of itself, 
given that the Occupational Safety and Health Act has an express 
definition of ``national consensus standard.'' 29 USC Sec. 652 (3)(9). 
There is a gap between this definition in OSHA's enabling legislation 
and the Agency's practice of incorporating by reference non-consensus 
standards. This gap is further accentuated by OSHA's continued reliance 
on non-consensus standards despite Congress' mandate in the NTTAA.
    Congressional action is needed to fill this gap. An efficient 
solution would be to require OSHA to rely only on ``national consensus 
standards'' as that term is already defined in the Occupational Safety 
and Health Act and is consistent with the NTTAA.
Introduction of ILMA
    The Independent Lubricant Manufacturers Association (ILMA), 
established in 1948, is a national trade association of 135 
manufacturing member companies. The overwhelming majority of these 
companies are ``small businesses'' as defined by the Small Business 
Administration. As a group, ILMA member companies blend, compound and 
sell over 25 percent of the United States' lubricant needs and over 75 
percent of the metalworking fluids (MWF) utilized in the country.
    Independent lubricant manufacturers by definition are neither owned 
nor controlled by companies that explore for or refine crude oil to 
produce lubricant base stocks. Base oils are purchased from refiners, 
who are also competitors in the sale of finished products. Independent 
lubricant manufacturers succeed by manufacturing and marketing high-
quality, often specialized, lubricants. Their success in this 
competitive market also is directly attributable to their tradition of 
providing excellent, individualized service to their customers.
    ILMA believes that non-consensus standards should have little or no 
role in the development of workplace health and safety policies in the 
United States, and that immediate legislative action is needed to 
remedy the improper reliance that various federal agencies, especially 
OSHA, place on these non-consensus standards.
    Given the closed nature of their development, non-consensus 
standards are substantially more susceptible to severe conceptual and 
measurement defects than consensus standards developed in an open, 
accountable and transparent process. Developing workplace health and 
safety policy in the shadow of these defects presents unacceptable 
threats to the health of American workers and creates costly burdens on 
businesses (large and small) across many industries.
ILMA's Current Nexus with Non-Consensus Standard Setting Organizations
    ACGIH has enjoyed a long track record of doing a tremendous amount 
of good for the field of industrial hygiene and the protection of both 
the American workforce and workforces around the globe. Since the 
1940s, ACGIH developed TLV recommendations for hundreds of chemicals 
and substances to which workers may be exposed in the workplace. For 
many years, ACGIH developed TLVs using an open, transparent development 
process based on sound scientific conclusions. All stakeholders in 
worker health and safety matters (those from government, academia and 
industry) had a seat at the table in developing TLVs. Unfortunately, 
this balance among stakeholders is no longer the case.
    Presently, ACGIH promulgates TLVs by way of committees that operate 
in secret with anonymous authors for the TLVs. Though industrial 
hygiene professionals in the private sector are still permitted to be 
ACGIH members, they are categorically banned from serving on any TLV 
committees. ACGIH further dampens industry input by routinely refusing 
telephone and in-person meetings to discuss TLV development. In short, 
industry has gone from having a seat at the table to being 
systematically barred from the TLV development process. Though the 
opportunity to provide written comments exists, there is no ``appeal'' 
process to challenge, question or even engage in a professional 
discourse with the people responsible for developing and finalizing the 
TLVs.
    ILMA believes that by closing the TLV development process, ACGIH 
has severely compromised the scientific value and legitimate utility of 
TLVs. Although ACGIH remains a private entity and has the right to 
conduct its membership, internal governance and TLV development 
procedures as it sees fit, a massive problem is created by the 
unwarranted credence that federal agencies, namely OSHA, give to 
ACGIH's TLV development process and how these agencies currently use 
newly-generated TLVs as a substitute for their own notice and comment 
rulemaking.
    It is instructive for the Subcommittee to examine ACGIH's statement 
of position on its TLV development process at http://www.acgih.org/tlv/
PosStmt.htm. ACGIH acknowledges that it does not evaluate the economic 
and technical feasibility of its recommendations or the availability of 
acceptable methods to determine compliance. ACGIH also points out that 
it does not follow a consensus process as the TLV ``does not represent 
a consensus position that addresses all issues raised by all interested 
parties.'' While ACGIH makes these and other disclaimers about its TLV 
development process and the use of its TLVs, the group conveniently 
ignores that it knows how its TLVs are used. Moreover, ILMA suggests 
that the Subcommittee ask OSHA how much taxpayer money is spent each 
year on ACGIH publications, including the TLV handbook, and staff 
involvement in the organization.
    There is a direct connection between the closed-process, secret 
development of ACGIH TLVs and affirmative worker health and safety 
regulatory responsibilities that American employers have under federal 
law. Under the Hazard Communication (HazCom) Standard, OSHA 
automatically adopts the latest version of ACGIH's TLV list every year 
and requires that manufacturers, including ILMA members, list the 
latest TLV limits on any Material Safety Data Sheet (MSDS) that they 
generate for use in the workplace. OSHA also uses new TLVs as the basis 
for, and to support, rulemaking actions that it initiates. OSHA can 
issue citations to employers under its ``General Duty Clause'' for 
violations of TLVs.
    More important than the fact that the TLV development process and 
subsequent incorporation into U.S. worker health and safety regulations 
is patently unfair and fundamentally inconsistent with the premise of 
federal regulations (notice and the opportunity to comment and 
ultimately appeal), this non-consensus process generates defective 
decisions that have the potential to compromise the health and safety 
of the very workers the TLVs are designed to help as well as creating 
expansive economic burdens on the business community, particularly the 
manufacturing sector. To illustrate, consider ACGIH's efforts to create 
a new TLV for mineral oil and mineral oil used in metalworking 
operations.
ACGIH's Proposed TLV for Mineral Oil--The Metalworking Fluid Industry's 
        Perspective
    On February 3, 2006, ACGIH released a draft version of a TLV 
recommendation for ``Mineral Oil Used in Metal Working'' and ``Mineral 
Oil, Pure, Highly and Severely Refined.'' When used in metalworking 
situations, the draft TLV proposes a reduction from 5 mg/m3 to 0.2 mg/
m3, time-weighted average (TWA). For ``pure'' mineral oil, the TLV 
remains at the current 5 mg/m3 TLV-TWA. In both cases ACGIH classifies 
highly and severely refined mineral oil as non-carcinogenic (A-4).
    In other words, ACGIH is proposing to single-out mineral oil when 
used in metalworking operations and to reduce the TLV in those 
circumstances by a factor of 25.
    As noted above, ILMA members manufacture more than 75 percent of 
all MWFs used in the United States. The scientists and industrial 
health and safety professionals that work for ILMA member companies 
likely account for the highest concentration of expertise on MWFs in 
the nation, if not the world. Because of ACGIH's closed and secretive 
TLV development process, ILMA's members had no role in developing the 
proposed mineral oil TLV.
    From ILMA's preliminary assessment of the proposed TLV, there also 
appears to be a number of fundamental defects that are: (1) 
definitional; (2) conceptual, and (3) measurement/quantitative in 
nature. There is also a lack of context for the proposed TLV. These 
defects preclude the proposed TLV from presenting any positive value in 
the effort to protect worker heath and safety and will place an 
unconscionable economic and unnecessary regulatory burden on thousands 
of businesses, large and small.
Definitional Defects
    MWFs are used in the processes of metal shaping, cutting and 
grinding. MWFs are also used to cool and lubricate in the metalworking 
environment. Though there are thousands of MWF products, most fall into 
four basic categories: (1) straight or neat oils; (2) soluble oils; (3) 
semi-synthetics; and, (4) synthetics.\1\ Three of the four general 
categories of MWFs, straight, soluble and semi-synthetics all contain 
some quantity of mineral oil. Some have quite a bit of mineral oil 
(straight oil can have upwards of 90 percent ), and some have very 
little mineral oil (semi-synthetics concentrates can have as little as 
5 percent), especially after the concentrates are diluted before use.
---------------------------------------------------------------------------
    \1\ Straight oils, used in today's MWFs typically consist of 
severely-solvent refined or severely-hydrotreated petroleum oil, or 
other oil of animal, vegetable or synthetic origin used singly, or in 
combination with performance additives. A movement toward exclusive 
industry use of severely refined base oil began in the 1960s and was 
complete by the mid-1980s, especially with the promulgation of the 
Hazard Communication Standard by the Occupational Safety and Health 
Administration.
    Soluble oils contain severely-refined based oil, emulsifying agents 
and performance additives. The base oil content ranges from 30 percent 
to 85 percent, and these products, sold in concentrate, are then 
diluted with water at ratios ranging from 1:5 to 1:40.
    Semisynthetics contain an even lower amount of severely refined 
base oil, maybe 5 percent to 30 percent (in the concentrate), and a 
higher fraction of emulsifiers and water (up to 50 percent of the 
concentrate). In concentrate, semisynthetics are translucent and are 
typically diluted with water at ratios ranging from 1:10 to 1:40.
    Synthetics contain no mineral oil whatsoever.
---------------------------------------------------------------------------
    Though the proposed TLV does not define ``Mineral Oil Used in Metal 
Working,'' it notes that the proposed TLV of 0.2 mg/m3 is ``recommended 
for occupational exposure to mineral oil aerosols in metal working 
operations where additives and metal or microbial contaminants are 
present.'' This statement appears to suggest that any MWF that contains 
some unspecified amount of mineral oil would be subject to the proposed 
TLV for mineral oil. Indeed, virtually all metalworking fluid products 
contain performance additives and, as a consequence of being used, 
contain very small pieces of the metal being ``worked.'' Though ACGIH's 
stated goal is to reduce the alleged health impacts of mineral oil 
mist, the practical impact is to regulate thousands of metalworking 
products, some of which contain only a small fraction of highly refined 
mineral oil.
    There is a major ``disconnect'' between ACGIH's stated purpose for 
proposing the new TLV (reduced occupational exposure to mineral oil 
mist) and the practical effect (setting a single TLV for a multitude of 
industrial products by way of an overly broad definition). The approach 
completely ignores not only the plurality of metalworking fluid 
products, but also the even larger plurality of industrial applications 
of metalworking fluid products. Furthermore, the practical effect of 
the definition (setting a TLV for most metalworking fluids regardless 
of mineral oil content) is in direct conflict with ACGIH's decision to 
limit TLV documentation to studies on straight mineral oil used in 
metalworking operations only, and to expressly exclude studies on the 
alleged heath effects of metalworking fluids. ACGIH, in other words, 
has proposed a de facto TLV for metalworking fluids while 
simultaneously and expressly excluding all studies of metalworking 
fluid.
    ILMA believes that ACGIH's proposed definition of ``Mineral Oil 
Used in Metal Working'' simply could not be generated by an 
organization that relies on an open, consensus-based process for 
developing standards. The definitional inconsistencies between intended 
purpose and practical effect, not to mention the ``Catch-22'' 
documentation problem would just not make it through the brainstorming 
phase, let alone all the way to a proposed standard.
Conceptual Defects
    The TLV distinguishes between ``pure'' mineral oils and mineral 
oils used in metal working operations. The proposed TLV for ``pure'' 
mineral oil 5 mg/m3 is twenty-five times higher than the proposed TLV 
for mineral oil used in metalworking, i.e., 0.2 mg/m3. ACGIH premises 
this distinction primarily on the presence of additives in metalworking 
fluids.\2\ The existence of metals and microbial contaminants is also 
cited.
---------------------------------------------------------------------------
    \2\ American Conference of Governmental Industrial Hygienists, 
Draft Total Limit Value Documentation, Mineral Oil (2006) at 1.
---------------------------------------------------------------------------
    The proposed TLV also contains the following language:
    A wide range of additives are used at concentrations ranging from a 
few parts per million to about 20% to modify the physical and/or 
chemical characteristics of mineral base oils in order to provide the 
performance requirements of specific applications. Additives are often 
proprietary materials and composition details will vary between 
individual suppliers.\3\
---------------------------------------------------------------------------
    \3\ Id. at 2.
---------------------------------------------------------------------------
    This distinction suggests that the alleged health effects of 
mineral oil in metalworking operations are due to constituents other 
than highly refined mineral oil--the additives, microbial contaminants 
and small pieces of metal commonly known as ``fines'' or ``swarfs'' 
generated by the metalworking process. ACGIH identifies neither 
additives nor microbial contaminants with any specificity, other than 
noting that these things ``vary.''
    It stands to reason that if ACGIH's hypothesis is that constituents 
``in'' or ``added'' to mineral oil when mineral oil is used in 
metalworking are the source of the alleged health effects, most of 
their attention should be focused on those constituents. Rather than 
dramatically lowering the TLV for mineral oil when used in 
metalworking, efforts should be undertaken to at least identify which 
constituents or combination of constituents (be they additives, 
microbial contamination or metal fines or swarfs) could be associated 
with any of the alleged occupational health effects. Once identified, 
suspect additives or microbial contamination phenomena should then be 
studied directly. This is an important point: by proposing to 
dramatically lower the TLV for mineral oils used in metalworking, ACGIH 
misses the significant opportunity to focus the resources of the 
organization on what might be truly causing the adverse health effects 
sometimes observed: microbial contamination.
    This conceptual bungling is not merely a theoretical or academic 
problem. To the extent that an additive, a combination of additives or 
microbial contamination actually does present an occupational exposure 
risk, a TLV for mineral oil used in metalworking does nothing to 
protect against other occupational exposures to the same additives or 
combination of additives. More specifically, the same additives or 
contaminants could be found in synthetic metalworking fluids or 
metalworking fluids containing animal or vegetable oil--neither of 
which contain any mineral oil.
    ILMA believes that these conceptual defects, just like the 
definitional defects would have been quickly rooted-out and corrected 
to the extent that ACGIH's TLV process was open and transparent rather 
than a closed, non-consensus process.
Measurement/Quantitative Defects
    There are a number of critical measurement and quantitative 
interpretation errors in the proposed TLV that would not exist if the 
development process were open.
    First, the test method contemplated to assure compliance with the 
new TLV does not just measure mineral oil; it measures ``inhalable 
particulate mass.'' This test does not directly and specifically 
measure oil mist by itself, but rather a collection of general 
particulates, oil mist, and any organic compound that adheres to the 
sample and measuring equipment.
    Second, reliable measurements of total particulate at a level of 
0.2 mg/m3 are not statistically feasible using standard measurement 
procedures. In other words, no generally available test procedure 
exists that would permit an industrial hygienist to even know whether a 
0.2 mg/m3 is being achieved in any occupational setting. Conceptually, 
this is not unlike a state trooper using a radar device that can 
determine vehicle speed with an accuracy of +/- 5 miles per hour 
deciding to issue a speeding ticket for a motorist clocked at 66 mph in 
a 65 mph zone. The decision to set an exposure limit below what 
existing tests can tentatively measure would not pass muster in a true 
consensus standard setting process. Setting an exposure limit beyond 
what can be measured using state-of-the-art testing procedures is, in a 
word, silly.
Lack of Context for TLV Development
    In addition to the manifold defects described above, ACGIH appears 
to have also largely ignored the fruits of an intensive discourse among 
the federal government, academia, industry and the courts regarding 
MWFs that has taken place over the past 13 years.
    In 1993, the United Auto Workers (UAW), who is scheduled to testify 
at today's hearing, petitioned OSHA to regulate more stringently 
metalworking fluids and the components contained in the fluids (UAW 
sought to lower the Permissible Exposure Limit (PEL) for oil mist 
(mineral oil) from 5 mg/m3 to 0.5 mg/m3). The petition was 
unsuccessful, and UAW was also unsuccessful in asking the courts to 
force OSHA to take any regulatory action on MWFs. UAW v. Chao, 361 F.3d 
249 (3rd Cir. 2004).
    Concurrent with UAW's legal efforts, the federal government and 
industry continued to focus considerable attention on MWFs. Throughout 
the 1990s, industry, labor and the federal agencies partnered on a 
series of joint committees, seminars, meetings and workshops to discuss 
and develop better ways to understand the potential occupational risks 
associated with MWFs and voluntary strategies to address those 
potential risks. Notable efforts included:
     Multi-day symposiums in 1995 and 1997 on the metalworking 
environment, respiratory health and metalworking systems management 
jointly sponsored by NIOSH and American Automobile Manufacturers 
Association (AAMA). The events drew hundreds of people, including those 
from labor, government and other stakeholders;
     Organizational Resource Counselors (ORC), a human resource 
and health/safety consulting firm, convened a metalworking fluid task 
force in 1996 and published a comprehensive ``Metal Removal Fluids 
Management Guide'' in 1997 to be used by machine operators;
     ILMA formed the Metalworking Fluids Product Stewardship 
Group (MWFPSG) and joined ORC's efforts to issue a second edition of 
the Metal Removal Fluids Management Guide; and
     ACGIH held a two-day scientific symposium entitled 
``Health Effects of Mineral Oil Mist and Metalworking Fluids 
Symposium'' in 2002, which was co-sponsored by ORC Worldwide, API, and 
the American Industrial Hygiene Association.
    None of these above summarized efforts seem to have been 
incorporated into ACGIH's draft TLV for mineral oil used in 
metalworking, especially many of the peer-reviewed papers presented at 
the 2002 ACGIH symposium.
The Ripple Effect--The Challenges That The Work Force and Business 
        Community Face When Federal Agencies Incorporate Defective Non-
        Consensus Standards into Their Regulations
    In the event that the proposed TLV for mineral oil used in 
metalworking is finalized by ACGIH and subsequently adopted by OSHA, a 
chain reaction of needlessly costly events would take place.
    First, all businesses that manufacture or use metalworking fluid 
that contains mineral oil as either a base or ingredient will be 
required to revise their MSDS information for those products. Costs 
associated this revision would be, on average, in the low six figures 
for each MWF manufacturer.
    Second, businesses that use such metalworking fluids in their 
manufacturing operations (the customers of ILMA members) would be 
pressured to comply with the new dramatically lower TLV. One strategy 
would be to invest in costly new engineering controls in their 
facilities in an effort to try to meet the new impractical TLV. Such 
efforts would require expensive new machines or retrofitting existing 
machines, and the costly installation or retrofitting of ventilation 
systems. Prohibitive costs across the industry would be substantial and 
would likely exceed the capabilities of many smaller companies. Another 
option would be for customers to switch to synthetic or vegetable-based 
metalworking fluid products, which tend to be relatively more expensive 
than metalworking fluids that contain mineral oil. Though some ILMA 
member companies that specialize in synthetic metalworking fluids would 
likely have some benefit, the change would cause palpable market 
disruption in the industry. The third option for many customers of ILMA 
members would be to move their manufacturing operations overseas.
    In addition to these immediate steps, insurance rates could rise in 
anticipation of personal injury claims premised on the defective TLVs. 
Legal costs associated with such actions would burden these 
manufacturing businesses even further.
    Putting a dollar figure on these events is difficult, especially 
given the intangible costs of industry's collective understanding of 
the confusing aspects of the TLV. Nevertheless, some of the estimates 
generated by the OSHA Metalworking Fluid Standards Advisory Committee 
process from 1997 through 1999 may prove instructive. During this 
process, the costs to retrofit existing automobile manufacturing 
facilities to achieve an exposure level for metalworking fluid of 0.5 
mg/m3 were estimated to be about $1.9 billion for what was then the 
U.S. ``Big Three,'' on top of the estimated $1 billion voluntarily 
spent on exposure reduction projects. Given that one estimate suggested 
that large automotive machining plants represented about 10% of the 
overall metalworking, it was estimated that the costs to achieve a 
level of 0.5 mg/m3 would be about $19 billion (in 1998 dollars). The 
costs to achieve a 0.2 mg/m3 TLV would be significantly higher.
    The above-summarized defects are so serious as to render the 
proposed TLV effectively useless in any effort to improve occupational 
health and safety in the context of metalworking. Therefore, all monies 
spent and all actions undertaken by industry in response to this TLV 
being finalized and adopted by reference in OSHA's HazCom Standards 
will be money and time wasted. Further, because the focus is on mineral 
oil and not the additives or contaminants that might be truly causing 
the problem, dollars spent to retrofit existing machine tools with new 
engineering controls may still not yield a workplace setting fully 
protective of worker health and safety. The mistake will be measured in 
billions of dollars.
Possible Solutions to the Problem of the Federal Government's Improper 
        Reliance on Non-Consensus Standards
    In the scientific and research community, concepts and opinions 
(whatever the subject matter) that are not subject to challenge and 
peer-review by other scientists and researchers through an open, 
transparent process are generally accorded very little value. For these 
reasons, non-consensus standards, like TLVs now developed by ACGIH 
should be accorded very little value and should have minimal influence 
over industrial hygiene matters because they are patently non-consensus 
standards.
    OSHA's tradition of annually adopting ACGIH's new TLV list has the 
practical effect of assigning an unwarranted and disproportionate 
importance to ACGIH's TLVs and sets into motion an absurd and needless 
``fire drill'' for businesses impacted by the new TLVs and fosters an 
utterly false sense of security from the standpoint of occupational 
health and safety, because the TLVs are premised on the interpretation 
and evaluation of scientific data in a non-consensus setting.
    If Congress enacted legislation (such as the provisions found in 
Senator Enzi's (R-WY) suite of OSHA reform bills, (S. 2066 to be 
specific)) that prohibits OSHA from adopting non-consensus standards, a 
number of very positive developments could take place.
    First, in an effort to keep their TLV tradition alive, we suspect 
that ACGIH would voluntarily take efforts to reform the TLV development 
process so that it fit the notion of a ``national consensus standard'' 
as that term is defined in the Occupational Safety and Health Act 
(codified at 29 USC Sec. 652 (3)(9)). OSHA would then also be able to 
rely on ACGIH's efforts in the manner contemplated by Congress in the 
NTTAA.
    Second, by eliminating the monopoly that ACGIH has on developing 
occupational health and safety occupational exposure limits, other 
private organizations would have a legitimate opportunity to generate 
competing consensus standards. This competition would undoubtedly 
improve the integrity and quality of occupational health and safety 
data and the thoughtful application of the same in an effort to truly 
protect the American worker.
    Third, and most importantly, the development of patently defective 
standards, such as the ACGIH TLV for mineral oil used in metalworking 
and other TLVs would no longer have artificially fertile ground in 
which to take root, and grow unchecked into flawed occupational 
exposure limits.
Conclusion
    ILMA greatly appreciates the Subcommittee's continued interest in 
the topic of the use of non-consensus standards by federal agencies and 
respectfully urges that the Subcommittee take legislative action to 
assure that when federal agencies do use standards generated by the 
private sector, the standards are developed in an open, consensus 
process.
    We are, of course, happy to respond to any questions this statement 
may have raised.
                                 ______
                                 

 Letter Submitted by David Felinski, Safety Director, the Association 
   for Manufacturing Technology, Secretariat, ANSI B11 Series Reports

                                                    April 27, 2006.
Hon. Charlie Norwood,
Chairman, Subcommittee on Workforce Protections, Committee on Education 
        and the Workforce, Rayburn House Office Building, Washington, 
        DC.
    After attending this morning's House of Representatives hearing 
(Subcommittee on Workforce Protection--non-voluntary consensus 
standards), I take strong exception to one of the comments Dr. Mirer 
(International UAW) made during his testimony. Although he was 
generally speaking about consensus standards, he specifically mentioned 
``machine tool standards'' and made the following assertion that ``they 
are not really consensus standards because it's just the users and the 
designers sitting around the table writing them.''
    I am the Safety Director for the Association for Manufacturing 
Technology (AMT). I am also the U.S. TAG Administrator to two separate 
ISO Technical Committees (in other words, I provide the U.S input into 
the ISO standards process in two separate committees), and I am the 
ANSI-accredited Secretariat and Standards Developing Organization (SDO) 
to over thirty American National (consensus) Standards and Technical 
Reports (ANSI B11 Series) on the subject of machine tool safety, 
ergonomics, risk assessment, control reliability, noise measurement, 
mist control and related topics. As Secretariat and Administrator, it 
is my role to ensure that we rigorously adhere to the ANSI (and ISO) 
developmental principles of Balance, Openness, Due Process, Consensus, 
and a mechanism for Appeals. I can assure you (and so can our ANSI 
auditor) that we maintain our accreditation precisely because we take 
those principles VERY seriously and adhere to them. Dr. Mirer's 
assertion is unfounded (certainly in our case, and I suspect it has 
little or no merit for the 203 other ANSI-accredited SDOs, but you 
should probably verify that with ANSI directly).
    I am attaching a copy of our ANSI B11 Accredited Standards 
Committee roster; you will note that we have quite a variety of 
interest groups besides just ``users'' and ``designers'' including both 
OSHA and NIOSH. The International UAW used to be a Member of the B11 
ASC until their representative retired a few years ago. We have been 
urging them to replace that person on the B11 ASC ever since (including 
my direct appeal to Dr. Mirer at the conclusion of today's hearing).
    I should very much appreciate it if this ``correction'' to Dr. 
Mirer's unfortunate misstatement about the consensus standards process 
is entered into today's formal procedural record. Thank you.
            Sincerely yours,
                                            David Felinski,
                                              ANSI B11 Secretariat.

                                                  B11 ASC 2006
----------------------------------------------------------------------------------------------------------------
                                                                                              Member Interest
        Company                      Delegate                        Alternate                    Category
----------------------------------------------------------------------------------------------------------------
AIAA--Aerospace          Mr. Willard J. Wood, ARM         Mr. Lance E. Chandler            Trade Association
 Industries Association  Safety Administrator             Equipment Engineer
 of America              The Boeing Company               The Boeing Company
                         PO Box 3707                      P.O. Box 3707 M/C: 50-51
                         MC 5C-04                         Seattle, WA 98124-2207
                         Seattle, WA 98124-2207           Phone: 253-846-4018
                         Phone: 253-931-6491              Fax: 253-846-4149
                         Fax: 253-931-2747                Email: lance.e.chandler@ boeing
                         Email: willard.j.wood@ boeing.c   .com
                          om
----------------------------------------------------------------------------------------------------------------
AEC--Aluminum Extruders  Mr. Doug Hart                    ...............................  Industrial/Commercial
 Council                 EHS Manager
Mr. Melvin Mitchell      Pennex Aluminum Company
Safety Director          50 Community Street
MI Metals                P.O. Box 100
301 Commerce Boulevard   Wellsville, PA 17365
Oldsmar, FL 34677        Phone: 717-432-9647 x. 322
Phone: 813-855-5695 x.   Fax: 717-432-4056
 231                     Email: dhart@ pennexaluminum.co
Fax: 813-855-6677         m
Email: mmitchell@ mimet
 als.com
----------------------------------------------------------------------------------------------------------------
AIAG--Automotive         Mr. Ron Tillinger                Mr. Kent Lenzen                  Trade Association
 Industries Action       OH&S Program Manager             OH&S Program Manager
 Group                   AIAG                             AIAG
                         26200 Lahser                     26200 Lahser
                         Suite 200                        Suite 200
                         Southfield, MI 48034             Southfield, MI 48034
                         Phone: 248-358-9777              Phone: 248-358-9777
                         Fax: 248-358-3253                Fax: 248-358-3253
                         Email: rtillinger@ aiag.org      Email: klenzen@ aiag.org
----------------------------------------------------------------------------------------------------------------
ASSE--American Society   Mr. Bruce W. Main P.E.           Mr. George V. Karosas            Professional Society
 of Safety Engineers     President                        Senior Consultant
                         Design Safety Engineering, Inc.  1100 West 31st Street
                         PO Box 8109                      La Grange Park, IL 60526
                         Ann Arbor, MI 48107              Phone: 708-352-9430
                         Phone: 734-483-2033              Fax: 708-352-9432
                         Fax: 734-483-9897                Email: gvkarosas@ esi-il.com
                         Email: bruce@ designsafe.com
----------------------------------------------------------------------------------------------------------------
AMT--The Association     Mr. Russell A. Bensman           Mr. Dan Soroka                   Manufacturer
 for Manufacturing       Staff Engineer                   Director of Workholding          Mr. Alan Metelsky
 Technology              The Minster Machine Company       Engineering                     Controls Engineering
                         240 W. 5th Street                Hardinge Inc.                    The Gleason Works
                         Minster, OH 45865-0120           P.O. Box 1507                    1000 University Ave.
                         Phone: 419-628-1765              Elmira, NY 14902                 Rochester, NY 14692
                         Fax: 419-628-2222                Phone: 607-378-4423              PH: 585-784-6927
                         Email: bensmanr@ minster.com     Fax: 607-735-0650                Fax: 585-241-4047
                                                          Email: dsoroka@ hardinge.com     Email: ametelsky@
                                                                                            gleason.com
----------------------------------------------------------------------------------------------------------------
The Boeing Company       Mr. Don R. Nelson                Mr. Robert Eaker, PE, CSP        User
                         Safety & Health Administrator    Safety & Health Administrator
                         The Boeing Company               The Boeing Company
                         P.O. Box 3105 M/C: 031-AB10      2223 Field Avenue, N.E.
                         Anaheim, CA 92803-3105           Renton, WA 98059
                         Phone: 714-762-3910              Phone: 425-891-9517
                         Fax: 714-762-0387                Fax: 425-271-6723
                         Email: don.r.nelson@ boeing.com  Email: robert.j.eaker@ boeing.c
                                                           om
----------------------------------------------------------------------------------------------------------------
CMI--Can Manufacturers   Mr. Geoff Cullen                 Ms. Jenny Day                    Industrial/Commercial
 Institute               Director of Government           Director Recycling
                          Relations                       Can Manufacturers Institute
                         Can Manufacturers Institute      1730 Rhode Island Avenue NW
                         1730 Rhode Island Avenue NW      Site 1000
                         Site 1000                        Washington, DC 20036
                         Washington, DC 20036             Phone: 202-232-4677
                         Phone: 202-232-4677              Fax: 202-232-5756
                         Fax: 202-232-5756                Email: jday@ cancentral.com
                         Email: gcullen@ cancentral.com
----------------------------------------------------------------------------------------------------------------
DEERE & Co.              Mr. Gary D. Kopps                Ms. Ellen Blanshan               User
                         Manager, Occupational Safety     Occupational Safety Specialist
                         Deere & Company--Technical       Deere & Company--Technical
                          Center                           Center
                         Occupational Safety Department   One John Deere Place
                         One John Deere Place             Moline, IL 61265-8098
                         Moline, IL 61265-8098            Phone: 309-765-5691
                         Phone: 309-765-5155              Fax: 309-765-9860
                         Fax: 309-765-9860                Email: blanshanellen@ johndeere
                         Email: koppsgaryd@ johndeere.co   .com
                          m
----------------------------------------------------------------------------------------------------------------
GM--General Motors       Mr. Michael Taubitz              Mr. Dallas Gatlin                User
                         Global Regulatory Liaison        Mgr. Engineering Integration
                         General Motors Corporation        H&S
                         PCC Central                      General Motors Corporation
                         2000 Centerpoint Pkwy.           PCC Central
                         M/C/483-520-194                  2000 Centerpoint Pkwy.
                         Pontiac, MI 48341-3147           M/C 583-520-098
                         Phone: 248-753-5771              Pontiac, MI 48341-3147
                         Fax: 248-753-5831                Phone: 248-753-4761
                         Email: michael.taubitz@ gm.com   Fax: 248-753-1004
                                                          Email: dallas.w.gatlin@ gm.com
----------------------------------------------------------------------------------------------------------------
MBMA--Metal Building     Mr. Charles M. Stockinger        Mr. Charles E. Praeger           Trade Association
 Manufacturers           Executive Director               Metal Building Manufacturers
 Association             Metal Building Manufacturers      Assn.
                          Assn.                           1300 Sumner Avenue
                         1300 Sumner Avenue               Cleveland, OH 44115-2851
                         Cleveland, OH 44115-2851         Phone: 216-241-7333
                         Phone: 216-241-7333              Fax: 216-241-0105
                         Fax: 216-241-0105                Email: mbma@ mbma.com
                         Email: mbma@ mbma.com
----------------------------------------------------------------------------------------------------------------
MPIF--Metal Powder       Mr. Dennis R. Cloutier, CSP      Ms. Teresa F. Stillman           Trade Association
 Industries Federation   President                        Senior Mgr., Stand. and Tech.
                         Cloutier Consulting Services      Services
                         6624 Parkland Avenue             Metal Powder Industries
                         Cincinnati, OH 45233              Federation
                         Phone: 513-941-2917              105 College Road East
                         Fax: 513-941-9727                Princeton, NJ 08540-6692
                         Email: dennis@ cloutierconsulti  Phone: 609-452-7700
                          ng.com                          Fax: 609-987-8523
                                                          Email: tstillman@ mpif.org
----------------------------------------------------------------------------------------------------------------
NIOSH--National          Mr. Richard S. Current, PE       Mr. James R. Harris              Regulatory Agency
 Institute for           Research Engineer                Safety Engineer
 Occupational Safety     NIOSH                            NIOSH
 and Health              Safety Research CDC              1095 Willowdale Road
                         1095 Willowdale Road             Morgantown, WV 26505-2888
                         Morgantown, WV 26505-2888        Phone: 304-285-6120
                         Phone: 304-285-6084              Fax: 304-285-6047
                         Fax: 304-285-6047                Email: jharris@ cdc.gov
                         Email: rcurrent@ cdc.gov
----------------------------------------------------------------------------------------------------------------
OSHA--Occupational       Mr. Ken Stevanus                 Mr. Robert Bell                  Regulatory Agency
 Safety and Health       Mechanical Engineer              Mechanical Engineer
 Administration          200 Constitution Ave. NW         200 Constitution Avenue, NW
                         Room N3609                       Washington, DC 20210
                         Washington, DC 20210             Phone: 202-693-2053
                         Phone: 202-693-2260              Fax: 202-693-1663
                         Fax: 202-693-1663                Email: bell.rb@ dol.gov
                         Email:stevanus.ken@ dol.gov
----------------------------------------------------------------------------------------------------------------
PCI                      Mr. John W. Russell              Mr. Keith Lessner                Insurance
Property Casualty        Technology Director              Vice President
 Insurers                Liberty Mutual                   Property Casualty Insurers
                         2100 Walnut Hill Ln.,Ste. 100    2600 South River Road
                         Irving, TX 75002                 Des Plaines, IL 60018
                         Phone: 800-443-2692-x2880        Phone: 847-297-7800
                         Fax: 972-518-1923                Fax: 847-297-5064
                         Email: john.russell@ libertymut  Email: keith.lessner@ pciaa.net
                          ual.com
----------------------------------------------------------------------------------------------------------------
PMMI--Packaging          Mr. Charles F. Hayes             Ms. Maria Ferrante               Manufacturer
 Machinery               Director of Technical Services   Director of Workforce
 Manufacturers           PMMI                              Development
 Institute               P.O Box 678                      PMMI
                         Marshall, MI 49068               Suite 600
                         Phone: 269-781-6567              4350 N Fairfax Drive
                         Fax: 269-781-6966                Arlington, VA 22203
                         Email: cfhayes@ voyager.net      Phone: 703-243-8555
                                                          Fax: 703-243-8555
                                                          Email: maria@ pmmi.org
----------------------------------------------------------------------------------------------------------------
PILZ--Pilz Automation    Ms. Roberta Nelson Shea          Mr. Lee Burk                     Manufacturer
 Safety, LP              General Manager                  Training Manager
                         Pilz Automation Safety, LP       Pilz Automation Safety, LP
                         7150 Commerce Boulevard          7150 Commerce Boulevard
                         Canton, MI 48187                 Canton, MI 48187
                         Phone: 734-354-0272              Phone: 734-354-0272
                         Fax: 734-354-3355                Fax: 734-354-3355
                         Email: R.NelsonShea@ pilzUSA.co  Email: L.Burk@ pilzUSA.com
                          m
----------------------------------------------------------------------------------------------------------------
PMA--Precision           Mr. William E. Gaskin            Ms. Christen A. Carmigiano       Manufacturer
 Metalforming            President                        Government Affairs Manager
 Association             Precision Metalforming           Precision Metalforming
                          Association                      Association
                         6363 Oak Tree Boulevard          6363 Oak Tree Boulevard
                         Independence, OH 44131           Independence, OH 44131
                         Phone: 216-901-8800 x121         Phone: 216-901-8800
                         Fax: 216-901-9190                Fax: 216-901-9190
                         Email: wgaskin@ pma.org          Email: ccarmigiano@ pma.org
----------------------------------------------------------------------------------------------------------------
PSDMA--Presence Sensing  Mr. James V. Kirton              Mr. Michael S. Carlson           Distributor/Retailer
 Device Manufacturers    Kirton Industrial Eq. LLC.       Safety Products Marketing
 Association             25 Skilton Rd.                    Manager
                         Watertown, CT                    Banner Engineering Corporation
                         Phone: 860-417-3097              9714 Tenth Avenue North
                         Fax: 860-417-3097                Minneapolis, MN 55441
                         Email: jimkirton@ optonline.net  Phone: 763-593-3934
                                                          Fax: 763-544-3213
                                                          Email: mcarlson@ bannerengineer
                                                           ing.com
----------------------------------------------------------------------------------------------------------------
RIA--Robotic Industries  Mr. Jeff Fryman                  Ms. Roberta Nelson Shea          Manufacturer
 Association             Director, Standards Development  General Manager
                         Robotic Industries Association   Pilz Automation
                         PO Box 3724                      7150 Commerce Blvd.
                         Ann Arbor, MI 48106-0000         Canton, MI 48187
                         Phone: 734-994-6088              Phone: 734-354-0272 x.208
                         Fax: 734-994-3338                Fax: 734-354-3355
                         Email: jfryman@ robotics.org     Email: R.NelsonShea@ pilzusa.co
                                                           m
----------------------------------------------------------------------------------------------------------------
Rockwell--Rockwell       Mr. Steven Dukich                Mr. Jay Tamblingson              Manufacturer
 Automation              Senior Commercial Engineer       Manager, Application
                         Rockwell Automation               Engineering
                         2 Executive Drive                Rockwell Automation
                         Chelmsford, MA 01824             1201 South Second Street
                         Phone: 978-446-3214              Milwaukee, WI 53204
                         Fax: 978-446-3322                Phone: 414-382-4556
                         Email: srdukich@ ra.rockwell.co  Email: jetamblingson@ ra.rockwe
                          m                                ll.com
----------------------------------------------------------------------------------------------------------------
STI--Scientific          Mr. Frank Webster                Mr. Chris Soranno                Distributor/Retailer
Technologies             Vice President, Engineering      Machine and Process Safety
Incorporated             Scientific Technologies, Inc.     Engineer
                         6550 Dumbarton Circle            STI Machine Service, Inc.
                         Fremont, CA 94555                4501 Mackall Road
                         Phone: 510-608-3443              South Euclid, OH 44121-4239
                         Fax: 510-608-7443                Phone: 216-224-5467
                         Email: fwebster@ wbstr.com       Fax: 440-794-7069
                                                          Email: chris--soranno@ sti.com
----------------------------------------------------------------------------------------------------------------
SMACNA--Sheet Metal and  Mr. Michael McCullion            Mr. Roy Brown                    Industrial/Commercial
 Air Conditioning        Director of Safety and Health    Safety Director
 Contractors National    SMACNA, Inc.                     SMARCA
 Association             4201 Lafayette Center Drive      1405 Lilac Drive North
                         Chantilly, VA 20151-1209         Suite 100
                         Phone: 703-995-4027              Minneapolis, MN 55422
                         Fax: 703-803-3732                Phone: 763-593-0941
                         Email: mmccullion@ smacna.org    Fax: 763-593-0944
                                                          Email: roy@ smarca.com
----------------------------------------------------------------------------------------------------------------
TMA--Tooling and         Mr. Daniel Kiraly                ...............................  Manufacturer
 Manufacturing           Director of Education
 Association             Tooling & Manufacturing
                          Association
                         1177 South Dee Road
                         Park Ridge, IL 60068
                         Phone: 847-825-1120 x346
                         Fax: 847-825-0041
                         Email: dkiraly@ tmanet.com
----------------------------------------------------------------------------------------------------------------
TMMNA--Toyota Motor      Mr. Barry Boggs                  Mr. Thomas Huff                  User
 Manufacturing North     Assistant Manager-Safety         Manager, Safety Eng. Support
 America                  Engineering Support             Toyota Motor Manufacturing
                         Toyota Motor Manufacturing        North America
                          North America                   25 Atlantic Avenue
                         1001 Cherry Blossom Way          Mail CodePESAF-NA
                         M/C:PESAF-NA/K                   Erlanger, KY 41018
                         Georgetown, KY 40324             Phone: 859-746-4203
                         Phone: 502-868-2367              Fax: 859-746-4069
                         CELL: 859-653-3484               Email: tom.huff@ tema.toyota.co
                         Fax: 502-868-2829                 m
                         Email:barry.boggs@ tema.toyota.
                          com
----------------------------------------------------------------------------------------------------------------

 Prepared Statement of Andrew P. Morriss, Galen J. Roush Professor of 
  Business Law & Regulation, Co-Director of Center for Business Law & 
   Regulation, Case Western Reserve University School of Law, Senior 
          Scholar, Mercatus Center at George Mason University*

    Chairman McKeon and Members of the Committee, thank you for 
inviting me to submit testimony on the use of non-consensus standards 
in workplace safety and health regulation. I am a professor of law and 
an economist with over forty published articles and book chapters, 
largely on regulatory issues. I have recently researched the use of 
non-consensus standards in OSHA rulemaking for a forthcoming article in 
the Administrative Law Review (Spring 2006), with coauthor, Susan 
Dudley, Director of the Regulatory Studies Program at the Mercatus 
Center at George Mason University. I have attached a draft of that 
article, ``Defining What to Regulate: Silica & the Problem of 
Regulatory Categorization,'' for the record.
---------------------------------------------------------------------------
    *Affiliation given for identification purposes only.
---------------------------------------------------------------------------
    Many current Occupational Safety and Health Administration 
standards are based on consensus standards developed by the American 
Conference of Governmental Industrial Hygienists (ACGIH). A historical 
review of how the ACGIH consensus standards became so influential is 
interesting and enlightening for the current debate.\1\
---------------------------------------------------------------------------
    \1\ More detailed references to the source materials for the 
information provided in this testimony can be found in, ``Defining What 
to Regulate: Silica & the Problem of Regulatory Categorization,'' by 
Andrew Morriss & Susan Dudley, forthcoming in the Administrative Law 
Review (spring 2006). Draft available at http://papers.ssrn.com/sol3/
papers.cfm?abstract--id=781684.
---------------------------------------------------------------------------
    Initially organized in 1936 as the Temporary Conference of Official 
Industrial Hygienists, the ACGIH soon became the National Conference of 
Governmental Industrial Hygienists (NCGIH) and in 1946, adopted its 
current name. Its influence grew after World War II, in part because 
organized labor focused its efforts mainly on wages, rather than 
workplace issues like industrial diseases. The private sector lead 
improvements in workplace health after the war, and industry turned to 
the industrial hygienists' trade organization for standards. The ACGIH, 
which had expanded its membership criteria to offset the decline in 
government activity after the war, began to receive requests from firms 
for standards governing workplace exposure. The organization formed the 
Committee on Industrial Hygiene Codes, and it created a table of 
``maximum allowable concentrations'' (MACs) as a first step toward a 
comprehensive industrial hygiene code in 1946. A separate Technical 
Standards Committee also considered the issues and took over the 
project. The organization also took advantage of increased interest in 
the subject during the war ``to organize and develop industrial hygiene 
agencies where they had not previously existed. By the end of the war a 
network of units had been established in nearly every state and many 
large industrial cities.'' \2\
---------------------------------------------------------------------------
    \2\ Jacqueline Karnell Corn, Protecting the Health of Workers: the 
American Conference of Governmental Industrial Hygienists, 1938-1988, 
at 43 (1989).
---------------------------------------------------------------------------
    ACGIH then published its maximum allowable concentrations as 
``Threshold Limit Values.'' The organization insisted that the TLVs 
were merely guides and not ``fine lines between safe and dangerous 
concentrations.'' \3\ Despite regular repetition of such warnings, 
however, many states used TLVs as legal limits in state-level workplace 
regulatory schemes, and they continue in widespread use around the 
world. The TLVs offered firms a focal point around which to structure 
their workplace safety campaigns, without requiring the firms to invest 
individually in the research necessary to set them. And firms could 
point to their compliance with ``industry standards'' if questions were 
raised about particular substances. The range of substances to which 
employees were exposed grew with the post-war explosion in the chemical 
industry, but there was no increase in dust exposures comparable to 
that introduced by the industrial revolution.
---------------------------------------------------------------------------
    \3\ See Corn at 60 (quoting the Committee on Threshold Limits).
---------------------------------------------------------------------------
    Between 1961 and 1970, it issued 220 TLVs, bringing the total to 
500. ACGIH, and the TLV committees within ACGIH, had considerable 
autonomy. The organization rejected the consensus approach of the 
American Standards Association because its members asserted that 
experts should set the health standards without interference from 
outsiders and that ACGIH members' governmental employment freed them 
from conflicts of interest. But, public choice theory raises the 
question, what were ACGIH's and others' interests in the regulatory 
adoption of the TLVs?
    First, the organization delivered professional status to its 
members, allowing them to both improve their status within firms and 
bureaucracies and to raise the profession as a whole. The ACGIH's role 
in setting standards adopted by state governments, and eventually the 
federal government, enhanced that status. Second, the adoptions gave 
the organization influence: Firms followed its recommendations, and 
government agencies adopted its TLVs. Strong evidence that the 
organization derived some benefit from their use can be found in the 
fact that the organization and its members tolerated such uses over 
long periods, uses that directly contradicted the TLVs stated 
purposes.\4\
---------------------------------------------------------------------------
    \4\ TLVs for about 400 substances were incorporated into OSHA 
consensus standards via their earlier use under the Walsh-Healey Act 
standards, although some were ``based on inadequate documentation.'' 
See Corn at 91 (describing OSHA's congressional authority to bypass 
rulemaking procedures and establish ``start-up'' standards). ACGIH did 
not attempt to stop OSHA's inappropriate use of the TLVs. See Corn at 
92 (clarifying that the TLVs were not meant to be standards). According 
to Corn, ``ACGIH seemed to have mixed emotions about use of the TLVs. 
They wanted to contribute to the new federal effort to bring about a 
healthy and safe workplace, and they were proud of the TLVs. Very 
little discussion can be found about this issue.'' Corn at 92. In the 
one discussion recorded in the minutes, ACGIH seems to have been 
resigned to OSHA's inappropriate use of the TLVs. See Corn at 92 
(elaborating that, although the ACGIH was displeased with the Labor 
Department for misusing the TLVs, it felt that if the Labor Department 
was going to use TLVs for that purpose it might as well use ACGIH's 
TLVs). The board responded to a question from the floor by saying: 
``There is nothing in my opinion, that ACGIH can do to prevent or stop 
anyone, any state or federal agency, from using our ACGIH TLVs in 
standards.'' Corn at 92-93. One participant recalled that, despite the 
language in the TLV publications warning against treating them as 
standards, the group ``was rather tickled with themselves that the TLVs 
were being used that way.'' Interview with Leonard J. Goldwater, in 
Corn at 145. Goldwater also noted that the ACGIH ``took no measures, 
whatsoever, to disassociate themselves from [OSHA's use of the TLVs] 
after it was made, after these things were adopted.'' Corn at 144. 
ACGIH standards were technically ``not consensus standards, but the 
legislation establishing OSHA required that only consensus standards be 
adopted.'' Salter, at 42. As one informant [to the study] suggested:
---------------------------------------------------------------------------
    Section 5(a) of the OSHAct mandates the Secretary of Labor to 
adopt, without dealing with title 5 of the Administrative Procedures 
Act, as soon as practicable, any of the consensus standards already 
established in federal regulations * * * Some argue that the Secretary 
had discussions (before adopting the standards). Others argue that the 
adoption was automatic because the big employers were already using 
these standards. Corn.
    In addition, ``There was some discussion in ACGIH about whether to 
adopt a consensus method, but ACGIH did not do so.'' Corn As one person 
described the situation:
    Stokinger saw the legislation (OSHAct) required consensus standards 
from that point on (for the purpose of their being adopted as OSHA 
regulations.) So he looked around and appointed industry and union 
representatives on the TLV committee for the first time. I don't think 
this is appreciated. Stokinger was wrong, but he thought he could make 
the TLV committee (into) a consensus body if there were industry and 
union representatives. Corn
    The ACGIH also played an important role for large firms, which, in 
turn, assumed key roles in creating and determining the TLVs. As one 
study noted, ``It is easy to document the influence of industry, and of 
industry consultants in ACGIH,'' \5\ especially since unions generally 
did not participate in the TLV process and the ACGIH developed TLVs 
largely in response to industry requests.\6\ Large firms thus obtained 
standardized TLVs around which state regulations, and eventually 
federal regulations, coalesced, helping prevent inconsistent standards. 
The process gave the firms influence over both the substances included 
and the levels set--influence they would find much harder to exercise 
over government regulatory bodies. ACGIH thus played a larger part than 
the Baptists (to large firms ``Bootleggers'') in a ``Bootleggers and 
Baptists'' regulatory coalition.\7\ It was a priestly caste in a 
theocracy.
---------------------------------------------------------------------------
    \5\ Corn. at 59. ACGIH and its members, however, deny that they are 
biased toward industry. Id. (explaining that many ACGIH members view 
the organization as an ``industry watchdog'').
    \6\ Liora Salter, Mandated Science: Science and the Scientists in 
the Making of Standards 47-48 (1988) (describing generally the informal 
process by which the ACGIH sets priorities and develops standards).
    \7\ The bootleggers and Baptists theory of regulation suggests that 
two different groups often work together to achieve political goals. 
See Bruce Yandle, Bootleggers and Baptists: The Education of a 
Regulatory Economist, AEI J. Gov't & Society 13 (May/June 1983), 
available at http://www.mercatus.org/pdf/materials/560.pdf. Like the 
bootleggers in the early twentieth-century South, who benefited from 
laws that banned the sale of liquor on Sundays, special interests need 
to justify their efforts to obtain special favors with public interest 
stories. The Baptists, who supported the Sunday ban on moral grounds, 
provided that public interest support. While the Baptists vocally 
endorsed the ban on Sunday sales, the bootleggers worked behind the 
scenes and quietly rewarded the politicians with a portion of their 
Sunday liquor sale profits. Id.
---------------------------------------------------------------------------
    Moreover, the eventual expansion of the federal role in 
occupational health and safety was foreseeable long before the creation 
of OSHA in 1970. The role of the ACGIH TLVs was also foreseeable. One 
ACGIH member and government agency employee described the use of TLVs 
by OSHA to a researcher as follows:
    ``I don't think it was accidental. There had been several attempts 
over the preceding years to promulgate an OSHAct * * * and it was just 
a question of time as to when there would be a national occupational 
health and safety program. The language of the OSHAct specifically 
provided for the Secretary of Labor to promulgate as interim or start-
up standards, national consensus standards, that had already been 
promulgated under certain Acts including the Walsh-Healy Act. Now the 
people in the Bureau of Labor Standards who were responsible for 
promulgating those standards were the same people who were going to be 
responsible under OSHA for setting the interim standards. Many of these 
people were ACGIH members but that doesn't make it an ACGIH decision. 
These people knew what was coming down the road and that they would 
have a job to do. If you had that responsibility, what would you use?'' 
\8\
---------------------------------------------------------------------------
    \8\ Salter at 42.
---------------------------------------------------------------------------
    The expansion of ACGIH's TLVs during the 1960s, and their 
``inappropriate'' use in state, and eventually federal, regulations 
served not only the interests of the members, the organization, and the 
large firms, but also politicians. President Nixon supported 
initiatives like environmental legislation, at least in part for 
political advantage, but he also wanted to keep these initiatives 
carefully constrained to avoid incurring economic penalties or 
alienating his business supporters. Adopting the consensus standards, 
already in use at many large businesses, both satisfied his political 
need to appear to be doing something and minimized the economic effects 
and potential decline in support from business.
    The passage of the OSH Act dramatically changed the institutional 
environment, and enhanced ACGIH's influence. The statute separated 
standard-setting and enforcement from the development of technical 
knowledge about workplace hazards, locating the former in OSHA and the 
latter in NIOSH.\9\ It required the agencies to act quickly to create a 
base of federal standards.\10\ OSHA had only two years to convert 
existing consensus standards into legally binding ones unless the 
agency found that doing so would not improve safety and health. This 
provision led to OSHA's wholesale adoption of things like the ACGIH 
TLVs as standards. Shortly after Congress established OSHA in 1971, the 
agency issued more than 4,000 general industry standards, based on 
national consensus standards of the American National Standards 
Institute and the National Fire Protection Association, as well as 
existing federal maritime safety standards. In just four months, OSHA 
took more than 400 pages of standards from a variety of prior programs 
and voluntary organizations and converted them into regulations. This 
had the effect of converting a set of largely discretionary industry 
guidelines into mandatory workplace design standards and, as noted 
below, changed the role of other agents in the market for health and 
safety.
---------------------------------------------------------------------------
    \9\ Under the OSH Act, when NIOSH recommends that OSHA promulgate a 
health standard, the Secretary of Labor must, within 60 days after 
receipt thereof, refer such recommendation to an advisory committee 
pursuant to this paragraph, or publish such as a proposed rule pursuant 
to paragraph (2), or publish in the Federal Register his determination 
not to do so, and his reasons therefor. The Secretary shall be required 
to request the recommendations of an advisory committee appointed under 
section 812(c) of this title if the rule to be promulgated is, in the 
discretion of the Secretary which shall be final, new in effect or 
application and has significant economic impact. 30 U.S.C. 
Sec. 811(a)(1) (2000).
    \10\ This was supplemented by a general duty provision. The Act 
established a general duty on the part of employers to ``furnish to 
each of his employees employment and a place of employment which are 
free from recognized hazards that are causing or are likely to cause 
death or serious physical harm to his employees; and [to] comply with 
occupational safety and health standards promulgated under this 
chapter.'' 29 U.S.C. Sec. 654(a)(1)-(2) (2000).
---------------------------------------------------------------------------
    Some have criticized OSHA for not attempting to ``sort through the 
existing standards to weed out those that were obviously silly and 
outdated.'' \11\ Salter's study and Corn's institutional biography both 
suggest, however, that because ACGIH members in their capacity as 
bureaucrats were involved in the process the explanation may not lie in 
a lack of knowledge about whether particular provisions were ``silly or 
outdated'' but rather in a wholesale acceptance of a broader role for 
TLVs than had ever been officially acknowledged as a goal by ACGIH. 
Reinforcing this interpretation is the recollection of an ACGIH member, 
who described the situation to Professor Salter as follows:
    At the time of OSHA's creation, there was a lot of soul searching 
at ACGIH. We wondered whether we should just fold up our tent and go 
home. There was a lot of encouragement in that direction coming from 
NIOSH. NIOSH felt that now it had legal responsibility for establishing 
criteria for standards, that ACGIH's TLV committee had done its job 
well, but that now we were in a new era and NIOSH superseded us. There 
were a lot of people at NIOSH who felt that way and weren't afraid to 
express it to the TLV committee and ACGIH itself. I was on the Board of 
Directors, but I think even more discussion was taking place in the TLV 
committees. It ended up with a wait and see attitude for a couple of 
years. By the mid1970s, there was a realization that the new system was 
not going to be responsive to current problems.\12\
---------------------------------------------------------------------------
    \11\ Thomas O. McGarity & Sidney A. Shapiro, Workers at Risk: the 
Failed Promise of the Occupational Safety and Health Administration 37 
(1993).
    \12\ Salter at 41.
---------------------------------------------------------------------------
    Converting the TLVs into standards served the interests of the 
ACGIH by giving it a rationale for continuing its work and served the 
interests of OSHA in getting regulations on the book quickly.
    Moreover, OSHA standards did not come into existence in a vacuum. 
Before OSHA, there were state and local regulatory efforts as well as 
vo luntary standards like the ACGIH TLVs. Large firms operating across 
jurisdictions benefited from nationalizing regulations, getting rid of 
conflicting local standards, and shifting the regulatory focus to 
Washington where they could afford to maintain lobbyists and lawyers. 
Indeed, the threat of conflicting state and local regulation remains a 
potent one. When the new Reagan Administration stopped work on a Carter 
Administration proposal for ``right to know'' rules, for exa mple, 
unions began lobbying for state and local versions. Worried about a 
patchwork of inconsistent rules, industries then sought federal rules 
that would preempt local standards. Adopting the ACGIH TLVs, with which 
they were already familiar, gave larger firms an advantage and forced 
their smaller competitors to incur additional costs.
    The creation of NIOSH and OSHA led to ``an enormous growth of 
professionals'' in industrial hygiene: ACGIH membership boomed, and for 
the first time, a majority of ACGIH employees came from federal 
agencies. Membership soared from approximately 1,000 in 1968, to over 
1,500 in 1973, to almost 2,500 in 1983.\13\ An organization that began 
in 1938 primarily consisting of 76 employees, almost all state and 
local agency employees, grew to 3,720 members, with a substantial 
federal contingent, by 1988.\14\
---------------------------------------------------------------------------
    \13\ Salter at xi.
    \14\ Salter at x.
---------------------------------------------------------------------------
    In the case of crystalline silica, the subject of my research, 
knowledge of health effects grew after World War II largely through a 
combination of public and private investment. NIOSH and the 
International Agency for Research on Cancer (IARC) both pulled together 
a great deal of research on silica, but that research came from a 
mixture of private, nonprofit, and public sector funded researchers. 
Post-war problems with silica stem largely from OSHA's involvement. By 
ossifying the ACGIH standard, OSHA eliminated the flexibility of the 
ACGIH process without adding any compensating benefits (such as more 
comprehensive analysis) to the near universal acceptance of the TLV. 
OSHA's failure to respond to NIOSH and IARC since NIOSH first warned of 
the existing standard in 1974 is a textbook example of go vernment 
failure.
    The regulatory history of silica shows not only that our 
understanding of health effects is constantly evolving, but that 
knowledge about hazards is endogenous--it arises in response to outside 
events, regulations, and interest groups. Accepting particular states 
of knowledge as definitive is thus a mistake, as is failing to consider 
the incentives for knowledge production created by regulatory measures.
    Recognizing what Frederic Hayek called ``the knowledge problem'' is 
essential when it comes to understanding the appropriate role of 
organizations such as ACGIH, and occupational health issues 
generally.\15\ First, before issuing new regulations, OSHA should 
clearly define what market failures, if any, impede efficient solutions 
to address health risks. Both employers and employees have incentives 
to protect health and safety in the workplace. Lack of information, 
particularly due to the lo ng latency period for many occupational 
diseases, may dampen these incentives. If the problem is a lack of 
information on risks and remedies, OSHA, and its research counterpart 
NIOSH, should focus on generating and dispersing better information. 
Although occupational health is not a field in which market forces are 
trusted, the serious problems with the current system cannot be solved 
without recognition of the important role played by the Hayekian 
knowledge problem.
---------------------------------------------------------------------------
    \15\ See generally Friedrich A. Hayek, The Use of Knowledge in 
Society, 35 Am. Econ. Rev. 519 (1945) (discussing problems with 
economic theory and the refinements needed to resolve those problems). 
Hayek's central point was that decentralized markets focus dispersed 
information--information that no one individual (not even a regulator) 
can obtain--and convey it efficiently to market participants.
---------------------------------------------------------------------------
    The federal government can play two important roles in this 
information market place. It can be a supplier. Through entities like 
NIOSH, the government can sponsor and conduct research that will 
influence standards. It can be a consumer. Just as it did under the 
Walsh-Healey Act before OSHA's creation in 1970, the government can 
demand that its information suppliers meet standards the government 
believes are effective.
    Further, any regulatory action must recognize the diversity in 
exposure and response across the varied workplaces. Heeding the lessons 
we've learned from the history of silica in the workplace, it is 
important to contrast the interest group incentives provided by a 
regulatory effort aimed at developing a uniform standard with those of 
a policy aimed at generating and disseminating information. The uniform 
standard provides incentives to interest groups to invest resources in 
influencing the standard to suit private goals (for example, gain 
advantage over competitors). In contrast, a focus on information 
provides incentives for interest groups to compete to develop and 
provide better information in support of their views of the risks and 
remedies.
    The ``market'' for standards that existed before OSHA consisted of 
groups like the ACGIH, unions, trade associations, and others. NIOSH's 
entry into this market changed the dynamics, primarily because of the 
influence of NIOSH criteria documents in initiating OSHA standards. 
Encouraging the development of competing standards for occupational 
health would create market pressure for increasing knowledge about 
harms. Competitive standards have operated successfully in a number of 
areas, including organic food certification and kosher labeling, and 
have successfully improved quality in a number of areas.
    In contrast to flexible standards that respond to different 
information, a uniform standard proves hard to adjust as new 
information becomes available, as is evidenced by the current OSHA 
exposure limit of 0.10 mg/m3. Knowledge is dynamic, and uniform 
standards necessarily lock in expectations based on the level of 
knowledge available at a given time. In particular, regulations that 
specify which remedies are acceptable or unacceptable discourage 
innovation into better solutions.
    Economics teaches us that people respond to incentives and groups 
such as the ACGIH are no exception. A legitimate concern is that this 
could result in the ``capture'' of an organization by a set of interest 
groups. The best solution to this problem is to encourage competition 
among various organizations for evaluating health risks and developing 
standards. Competition would encourage exposure of inappropriate 
behavior, force organizations to justify their work product to win 
acceptance of their standards, and provide a marketplace of ideas about 
the most appropriate response. The problem we thus face is not that 
private organizations like ACGIH produce standards but that those 
standards sometimes become ossified through their adoption by 
government agencies, limiting the incentive to produce competing 
standards that could develop new solutions.
                                 ______
                                 
    [Additional submission by the Mercatus Center of George Mason 
University placed in permanent archive file, Defining What to Regulate: 
Silica & the Problem of Regulatory Categorization, forthcoming, 
Administrative Law Review, spring 2006, Andrew P. Morris and Susan E. 
Dudley, draft, 26 April 2006.]

   Prepared Statement of the Precision Machined Products Association

Executive Summary
    The protection of worker safety and health is an important national 
priority, and one with which the federal government is entrusted. This 
is not a new idea, Hippocrates said ``In the first place, do no harm.'' 
That is a powerful charge and only requires seven words to make the 
point. What is new today, however, is that, as industrial processes 
grow more complex, and materials increase in number, the charge to ``do 
no harm'' requires a few more resources than one wise old man and seven 
words.
    The OSH Act established as a foundation, the use of ``National 
Consensus Standards'' to assure that wisdom would be the cornerstone of 
their rulemaking and enforcement. The phrase ``National Consensus 
Standards'' provides us with a beacon of what was expected to be used 
as the basis of OSH regulatory activities. However today, ``National 
Consensus Standards'' are an illusion at best, they reflect neither 
national interests nor are they reflective of a true consensus, nor do 
they reflect a ``standard'' that would be constructed were a true 
``national consensus'' of authorities empanelled to develop them.
    The reliance of OSHA on non-consensus standards is bad governance, 
it's a bad example of how markets should work, its bad way to base 
policy, and it's bad science. Unless open consensus standards are used, 
there is no means to provide corrections--and those affected, those 
thought to be protected, the economy, the country and all of us will be 
impacted by the full weight of the law as directed by what ever the 
unknown biases, mistakes, omissions, and systemic errors the closed 
door process is subject to.
    Hardly a description of ``In the first place, do no harm.''
PMPA--Making The Parts That Make Our World Safer
    The Precision Machined Products Association is a not for profit 
501(c)6 association representing the manufacturing companies of the 
NAICS 332721 Precision Machining Industrial Classification. Sales in 
our industry are reported to be $8.96 billion dollars for 2004 
according to the US Census. Our industry consists of approximately 525 
industry establishments and approximately 71,662 employees. Our 
association represents 500 member companies, approximately 350 of which 
are directly engaged in NAICS 332721. The balance of our members are 
suppliers to our industry. Our member companies are smaller 
enterprises, (median sales around $4 million annually) that apply their 
machining and manufacturing know how to produce precision components 
that not only make our world run--but also make our world safer. 
Automotive parts produced by our members range from simple fasteners 
that might anchor a seat belt to the floor through complex safety 
critical, anti-lock braking components and parts for airbags for 
occupant safety. Our members make parts used in plumbing, HVAC, fluid 
power, electrical and electronic applications as well as for aerospace 
technologies. Our members also produce a host of components for 
military armaments and the Department of Defense.
    Many of our members are producing the ultimate in precision-
machined parts--medical implants such as bone screws and other 
implantable products. The products that we make are generally 
metallic--steel, aluminum, brass and titanium, and include many others. 
Our members manufacture parts to very precise geometries and tolerances 
by machining, that is, by taking stock removal by cutting using tools 
on both mechanical automatic screw machines and also using Computer 
Numeric Controlled (CNC) machines.
    In order to achieve the high precision and surface finishes needed 
by today's technologies, metalworking fluids are used to remove the 
heat from the work, help remove the chip from the cutting area, and to 
provide lubricity, control build up, and perform other functions. With 
metalworking fluids such an important part of our process, it is 
critical to our industry's sustainability that any regulations applied 
to our processes be the result of good science and a functional policy 
environment where the checks and balances exist to assure that the 
interests of all affected parties are given fair regard.
    Our interest in the issue of non-consensus standards is driven by 
the fact that we will be the ones who have to bear the burden of bad 
policy and bad science implemented into law. Closed, smoke filled rooms 
have never been preferred to the fresh air and sunshine of open public 
processes, and the lack of an open dialogue and opportunity to 
participate in the processes that will determine the rules of the game 
for our manufacturing operations and our worker's safety is troubling, 
when we and other affected constituencies are not even given a seat at 
the table.
    Congressional action is needed to assure that OSHA relies only on 
National Consensus Standards that are developed in an open, balanced 
public process such as was directed by the National Technology Transfer 
and Advancement Act of 1995 (NTTAA); in fact the legislation that 
enables the Occupational Safety and Health Administration, 29 USC 
Sec. 652(3)(9) also calls for true open national consensus. The current 
reliance on non-consensus standards excluding input from those affected 
seems contrary to the spirit of these congressional mandates.
PMPA Objects To The Use Of A Closed Non-Consensus Process For 
        Determining TLV's For Regulatory Enforcement
    American Council of Government Industrial Hygienists (ACGIH) does 
not employ an open consensus process where members from industry and 
other affected stakeholders may participate and share their intimate 
and practical knowledge on the subject. The closed TLV development 
process makes for bad science. Science functions best when the facts 
and data used to create one's findings are subjected to open scrutiny 
of other professionals. The exclusion of other knowledgeable 
professional industrial hygienists thereby makes the TLV's not subject 
to the self-correcting nature of scientific discourse.
    This flaw in the process of creating TLV's thus condemns them as 
nonscientific, in the sense expressed by Mellett in 2004: ``when a 
scientist, regardless of their field of expertise, publishes the 
results of their work, other scientists will subject their work to 
verification. Thus errors in science are detected very quickly. Indeed, 
you can argue that scientific progress is impossible without the search 
for error.'' The ACGIH closed-shop model of only insiders and not 
industry professionals participating in the development of TLV's thus 
removes a key component of scientific legitimacy, the public and open 
examination, verification, and correction of errors by other 
professionals. The ACGIH non-consensus methodology thus can be seen as 
not just being bad science--but rather ``non-science'' in that it lacks 
this key self-checking mechanism of the scientific community.
PMPA Objects To The ACGIH's Process Ignoring Prior Art And Knowledge in 
        Their Process For Determining TLV's For Regulatory Enforcement
    ACGIH has ignored prior art and knowledge in the area of 
metalworking fluids in its apparent determination to lower the TLV 
regardless of the facts. There is a history of and body of knowledge on 
the subject of metalworking TLV's in the public starting initially with 
the unsuccessful petition of OSHA by the United Auto Workers to more 
stringently regulate metal working fluids and their components in 1993. 
The UAW then sought to use the courts to advance their case for 
lowering limits on Metalworking fluids--UAW v. Chao, 361 F.3d 249 (3rd 
cir.2004). PMPA was part of a successful industry effort to stop this 
unwarranted regulation. As other testimony has shown, symposia, task 
forces, and other meetings have been convened on the subject of 
metalworking fluids. Despite the outcome of UAW v. Chao, the same TLV 
is now being proposed via a non-public non-consensus ACGIH route.
    This ignoring of existing data and the court decision repudiates 
any claim that ACGIH might make for openness of its process or 
legitimacy of its dictates.
    PMPA Objects To The ACGIH's Process For Determining TLV's For 
Regulatory Enforcement In Which Alleged Causative Agents Remain 
Unidentified, Resulting In An Overly Broad Regulatory Action On All 
Mineral Oil Containing Metalworking Fluids
    The closed ACGIH process has resulted in a TLV standard for which 
the alleged causative agents remain unidentified. By not including 
industrial hygienists with industry expertise into their closed 
consensus process, our industry may soon be facing the task of managing 
a vague and undefined threat to our employee's safety--``mineral oils 
aerosols in metal working operations where additives and metal or 
microbial contaminants are present.'' This vague statement might be 
interpreted:
    A. That the metal working fluid, by nature of having mineral oil 
content is the basis for the need for the lowered TLV;
    B. That the additives might be the reason for the need for the 
lowering of the TLV;
    C. That the metal contaminants might be the reason for the lowered 
TLV;
    D. That microbial contaminants might be the basis for the 
recommendation for the lowered TLV.
    This overly broad, nonspecific statement is bad science in that it 
does not establish which if any of the constituents named might 
actually be causative and justify the lowering of the TLV. Thus, the 
non-consensus process employed by the ACGIH has resulted in, if we may 
be permitted to use a metaphor, a regulatory approach that attempts to 
``ban cars rather than arrest drunk drivers.'' Overly broad, all-
inclusive categories when no specific causative agent is identified 
makes for bad science, is bad policy, and it is sloppy governance.
PMPA Objects To The Potential Costs And Consequences Resulting From the 
        ACGIH's Non-Consensus Process For Determining TLV's For 
        Regulatory Enforcement
    The potential costs and consequences of the ACGIH TLV proposal 
resulting from their non-consensus process are significant to our 
economy and our way of life. The costs to implement compliance in 
manufacturing to the proposed TLV have been estimated to be about $19 
billion in 1998 dollars. Assuming that our GDP is $13 trillion, the 
cost of compliance with this rule would be one and a half tenths of a 
percent of US GDP. Our industry's total sales in 2004 were $8.96 
billion dollars. As a result of a closed shop, non-public, non-
consensus process, metalworking industries are likely to incur costs 
that are roughly double the total sales of the precision turned 
products industry's annual sales.
    The non-public, non-open, non-consensus process employed by ACGIH 
has neither identified allegedly harmful causative agents, nor a 
mechanism for employee harm--just an overly broad categorical 
condemnation of metalworking fluids in general if they contain mineral 
oils. However, there is no denying that the costs to reengineer our 
workplaces so that we can comply with the proposed TLV will close many 
of our shops and terminate the employment of many of our nation's most 
skilled workers. Does America want to take a family whose breadwinner 
operates two or three, million dollar pieces of precision machining 
equipment, who produces millions of dollars in sales revenue annually, 
earning up to $20 per hour plus benefits, producing more than up to 20 
foreign workers, and force them out of work? Just because a group of 
uninvolved people, without input from anyone affected, thought that we 
would be better off with a standard that is close to the limit of our 
current technology's ability to determine conformance with?
Summary
    The current closed, non-public, non-consensus process utilized by 
ACGIH lacks openness and any means of introducing daylight or any 
ability to correct or independently confirm the validity of its product 
Threshold Limit Values (TLV's) for regulating industry. By ignoring and 
excluding the input of all affected parties, the closed process 
employed by ACGIH is little more than bureaucratic bullying. This 
process may well have us on a fast track to waste--as it is conceivably 
a means of wasting almost one and a half tenths of a percent of U.S. 
GDP for no scientifically demonstrated benefits.
    That OSHA can continue to adopt and enforce non-consensus standards 
using force of federal law is bad policy, and preventing outside 
professionals from participating in the process removes any self-
correction that might actually give scientific credibility to that 
work. It is our hope that this Committee will help Congress get OSHA 
back on track to its foundational vision--open consensus standards and 
good science. Bureaucratic bullying and closed standards development 
should be phrases that best describe former Soviet governance, not 
American occupational safety and health rulemaking in the twenty first 
century.
                                 ______
                                 
    [Additional materials submitted from the American 
Conference of Governmental Industrial Hygienists (ACGIH) 
follow:]

   Prepared Statement of Robert D. Soule, EdD, CIH, CSP, PE, Chair, 
       American Conference of Governmental Industrial Hygienists

    The American Conference of Governmental Industrial Hygienists. 
(ACGIH) submits this statement to correct testimony presented before 
this Subcommittee at its April 27, 2006 Hearing on the Use of Non-
Consensus Workplace Health and Safety Standards. ACGIH thanks the 
Subcommittee for the opportunity to present this statement.
    Certain testimony presented by Mr. Henry Chajet and Ms. Elizabeth 
Marcucci contains incorrect statements and unfounded conclusions 
regarding ACGIH. This Statement is presented to correct the record.
    ACGIH is an independent, non-profit scientific organization that 
provides guidance to industrial hygienists on issues relating to health 
and safety in the workplace. ACGIH publishes Threshold Limit Values 
(TLV5) and Biological Exposure Indices (BEIs), which are based on 
scientific analysis of existing peer reviewed literature. The TLVs and 
BEIs are scientific opinions describing levels of workplace exposure 
that the typical worker can experience without adverse health effects. 
The TLVs and BEIs are guidelines to be used by industrial hygienists as 
one of many factors in evaluating the conditions in a specific 
workplace. They are health-based values. They are not standards and are 
not intended to be used as standards. TLVs and BEIs are initially 
published on ACGIH's website in draft form as a Notice of Intended 
Changes (NIC). These NICs are available to all interested parties, who 
are given at least a full six months to provide comments. All comments 
are carefully reviewed before any final TLV or BEI is published.
ACGIH Does Not Set Standards
    Five years ago, Dr. Patrick N. Breysse, as Vice Chair-Elect of 
ACGIH, submitted a written statement in response to Mr. Chajet's 
comments before this Subcommittee at an OSHA Rulemaking Hearing on June 
14, 2001. (See Attachment A, Statement of Patrick N. Breysse). Dr. 
Breysse's statement was a clear and concise message to Congress that 
ACGIH's TLVs ``are not developed for use in rulemaking proceedings or 
in standard setting activities.'' (Statement of Patrick N. Breysse, 
page 4) His statement contained several salient points that bear 
repeating as ACGIH again unfairly finds itself in the crosshairs of a 
Congressional hearing on the same issues that were raised in 2001.
    The main evidence cited by Dr. Breysse to support the fact that the 
TLVs and BEIs are not standards and are not intended to be used as 
standards is the Policy Statement on the Uses of TLVs and BEIs and 
Special Note to User that are printed inside the front cover of the TL 
Vs and BEIs Book that ACGIH publishes and distributes annually. The 
Policy Statement explains that TLVs are ``recommendations or guidelines 
intended for use in the practice of industrial hygiene'' and are ``not 
developed for use as legal standards and ACGIH does not advocate their 
use as such.'' On the same page, in a blocked paragraph titled 
``Special Note to User,'' ACGIH states that TLVs are ``not fine lines 
between safe and dangerous concentrations and should not be used by 
anyone untrained in the discipline of industrial hygiene.'' Dr. Breysse 
demonstrated that ACGIH has taken all reasonable measures to inform 
users of the TLVs and BEIs, as well as the general public, that it does 
not set standards and that the TLVs and BEIs are not intended to be 
used as standards.
    Five years later, ACGIH is again the target of harsh criticism and 
is wrongly being referred to as a standards setting entity by both Mr. 
Chajet and Ms. Marcucci, in testimony before this Subcommittee on April 
27, 2006. It seems that Dr. Breysse's comprehensive statement from 2001 
has received no proper consideration. Therefore, we now must reiterate 
our position that ACGIH is not a standards setting organization and 
that ACGIH does not intend that the TLVs or BEIs be used as standards.
    At the Subcommittee Hearing on April 27, 2006, Charles Norwood, 
Chairman, Subcommittee on Workforce Protections, displayed the 
definition of a ``national consensus standard,'' as defined in Section 
3 of the OSH Act of 1970, on two television screens at either side of 
the hearing room:
    The term ``national consensus standard'' means any occupational 
safety and health standard or modification thereof which (1), has been 
adopted and promulgated by a nationally recognized standards-producing 
organization under procedures whereby it can be determined by the 
Secretary that persons interested and affected by the scope or 
provisions of the standard have reached substantial agreement on its 
adoption, (2) was formulated in a manner which afforded an opportunity 
for diverse views to be considered and (3) has been designated as such 
a standard by the Secretary, after consultation with other appropriate 
Federal agencies. OSH Act of 1970, Sec. 3(9).
    Along with remarks made throughout the hearing, Chairman Norwood's 
intentions were clear with this presentation: federal regulatory 
bodies, such as the Department of Labor (``DOL''), should adopt 
workplace health and safety standards based on a national consensus 
standard and through the rulemaking process described in Section 6 of 
the OSH Act. ACGIH does not take issue with this concept. However, 
since ACGIH is not an organization that establishes either national 
consensus standards or non-consensus standards, it should not be 
excoriated if the DOL, or any other federal agency for that matter, 
chooses to refer to a TLV or BEI in the course of the agency's 
activities.
    Mr. Chajet testified that ACGIH adopts ``standards under a veil of 
secrecy'' and conducts ``secret, backdoor rulemaking.'' This rhetoric 
obfuscates the simple truth: ACGIH is not a standard setting body. It 
is a private, nongovernmental scientific organization that publishes 
guidelines for industrial hygienists based on the review of existing 
published, peer-reviewed scientific literature. No ACGIH guideline is 
published in final form without at least allowing for a full six-month 
public comment period. ACGIH has repeatedly stated that regulatory 
bodies should view TLVs and BEIs as an expression of scientific opinion 
and not as workplace standards.
ACGIH Responded to the ABA's Comments on the Flour Dust TLV
    The American Baker's Association (ABA), represented by Ms. 
Marcucci, Chair, ABA Safety Committee, presented testimony before the 
Subcommittee at its April 27, 2006 Hearing, criticizing the way that 
ACGIH establishes its scientific guidelines. Ms. Marcucci stated that 
ACGIH conducts ``its scientific evaluations and decision making 
completely in private, with no outside input or oversight,'' resulting 
in ``no confidence in the final work product.'' She bases this attack 
on allegations that the ABA was ``ignored'' in its attempts to contact 
ACGIH regarding the proposed flour dust TLV. Let us present the facts 
for the record.
    The ABA was dissatisfied with ACGIH's proposed TLV for flour dust 
and contracted with Sandler Occupational Medicine Associates (``SOMA'') 
to conduct its own review of the literature cited by ACGIH in the 
documentation supporting the TLV. After it was completed, the ABA 
submitted the SOMA review to ACGIH and requested that the proposed TLV 
on flour dust be withdrawn. Ms. Marcucci testified that the ABA 
received a summary dismissal, from ACGIH, of its request to withdraw 
the flour dust TLV. However, ACGIH's response to the SOMA study was not 
in the form of a summary dismissal but, rather, a comprehensive 
evaluation of the study and its reasons for not removing flour dust 
from the list of adopted TLVs. (See Attachment B, January 15, 2002 
Letter from ACGIH to James A. Bair, Robb S. MacKie and Gordon Harrison)
    On January 15, 2002, ACGIH submitted its evaluation of the SOMA 
study to the ABA, the North American Millers' Association and the 
Canadian National Millers Association. ACGIH clearly identified three 
specific issues--``Sensitization as an end-point'', ``Study criteria'' 
and ``Exposure threshold''--and carefully analyzed each in order to 
conclude that it was not persuaded to remove the flour dust TLV from 
its list of adopted values. However, the TLV Committee did incorporate 
certain materials from the SOMA study into the revised flour dust 
Documentation. Contrary to the testimony submitted by Ms. Marcucci, 
ACGIH has addressed the concerns and issues raised by the ABA regarding 
the flour dust TLV. This was not a process with no outside input. 
Outside input was, and is, encouraged and fully considered.
Conclusion
    Workplace safety is an important concern of all Americans. 
Regulatory agencies in the U.S. and abroad are charged with 
establishing standards to protect workers from being exposed to 
dangerous substances in the workplace. Industrial hygienists are one of 
the groups of professionals with responsibilities for evaluating 
workplace conditions.
    ACGIH investigates hazardous substances and conditions commonly 
found in the workplace by analyzing available peer reviewed literature. 
The evaluation is made by Committees of renowned scientists 
representing many disciplines. After evaluating the literature, the 
Committee publishes a comprehensive Documentation in draft form. The 
Documentation sets forth the level of workplace exposure that, based on 
the published peer reviewed guidelines, the Committee believes is a 
proposed safe level of exposure for the average worker. The draft 
Documentation including the proposed safe level of exposure (TLV or 
BEI) is then published for public comment. Comments are fully evaluated 
before a final TLV or BEI recommendation is made.
    ACGIH does not engage in consensus or non-consensus standard 
making. The United States District Court for the Middle District of 
Georgia has rejected the unfounded claims raised by Mr. Chajet and 
ruled that ACGIH is not a federal agency; that ACGIH is not a Federal 
Advisory Committee; that ACGIH is not required to follow the Federal 
Administrative Procedures Act; and that ACGIH has a First Amendment 
right to publish its scientific opinion. (See Attachment C, Opinion of 
U.S. District Court on Motion to Dismiss, IBSA v. ACGIH, (Civ. Action 
No. 5:04 CV-394).) We think that this Subcommittee should recognize the 
excellent work that ACGIH has done to promote worker health and safety 
for more than 65 years.
    ACGIH thanks the Subcommittee for this opportunity to correct the 
record in this matter.
                                 ______
                                 

   Prepared Statement of Patrick N. Breysse, Ph.D., CIH, Professor, 
      Bloomberg School of Public Health, Johns Hopkins University

    My name is Patrick N. Breysse, and I am a Professor at the 
Bloomberg School of Public Health at the Johns Hopkins University in 
Baltimore, Maryland. I hold a Ph.D. from the Johns Hopkins University 
School of Public Health. I also serve as Vice Chair-Elect of ACGIH 
Worldwide (the American Conference of Governmental Industrial 
Hygienists, Inc.) and as a member of the ACGIH Board of Directors. I am 
the Board of Directors' liaison to the ACGIH Chemical Substance TLV 
(Threshold Limit Values) Committee.
    I am submitting this statement on behalf of ACGIH in response to 
the statement made by Mr. Henry Chajet before this Subcommittee at its 
June 14, 2001 hearing on OSHA Rulemaking. On behalf of ACGIH, I thank 
the Subcommittee for the opportunity to present this statement.
    Mr. Chajet's statement contained certain conclusions that are not 
correct and certain facts that are incomplete. In order to set the 
stage for my discussion, there are some basic facts that should be 
understood:
    1. ACGIH does not set standards.
    2. ACGIH does not make submissions to government agencies.
    3. ACGIH does not participate in or submit comments in government 
rulemaking proceedings.
    4. ACGIH does not engage in lobbying and does not normally submit 
statements to Congressional Committees. This is the first Congressional 
Hearing in which ACGIH has participated. This statement is being 
submitted only to respond to the incorrect and misleading statements 
about ACGIH.
    5. ACGIH does not serve as a vehicle for government employees to 
avoid notice and comment rulemaking responsibilities.
    6. ACGIH is not a quasi-government agency or a federal public 
advisory committee.
    7. ACGIH does not act ``in secret'' as alleged by Mr. Chajet.
    8. ACGIH is not a de facto ``Federal Advisory Committee (FAG).'' 
What is ACGIH, What Does It Do, and How Does It Do It?
    ACGIH is a not-for-profit, scientific professional society with 
approximately 4,200 individual members. ACGIH members include 
occupational health and safety scientists who work for universities, 
private industry, for federal, state and local governments, and for 
others. As a scientific organization, ACGIH regularly publishes 
educational materials relating to worker health and safety issues. It 
holds educational events related to worker health and safety issues. It 
also provides industrial hygienists in at least 62 countries throughout 
the world, with a central resource for scientific information on issues 
related to occupational safety and health. This information assists the 
industrial hygienist in making independent assessments of diverse 
issues in the environment within which they practice their profession.
    ACGIH's most well known publication is its TLVs and BEIs book, 
which is published annually. I am submitting the 2001 version of this 
book with this statement for the record. It is this publication which 
is the center of the controversy created by Mr. Chajet.
    TLVs (Threshold Limit Values) and BEIs (Biological Exposure 
Indices) are developed as guidelines by ACGIH to assist in the control 
of potential health hazards in the workplace. ACGIH annually publishes 
a Policy Statement on the uses of TLVs and BEIs. This Statement, 
approved by the ACGIH Board of Directors on March 1, 1988, is contained 
on the inside of the front cover of the TLVs and BEIs book. It 
states:
``Policy Statement on the Use of the TLV's and BEI's
    ``The Threshold Limit Values (TLVs) and Biological Exposure Indices 
(BEIs) are developed as guidelines to assist in the control of health 
hazards. These recommendations or guidelines are intended for use in 
the practice of industrial hygiene, to be interpreted and applied only 
by a person trained in this discipline. They are not developed for use 
as legal standards and ACGIH does not advocate their use as such. 
However, it is recognized that in certain circumstances individuals or 
organizations may wish to make use of these recommendations or 
guidelines as a supplement to their occupational safety and health 
program. ACGIH will not oppose their use in this manner, if the use of 
TLVs and BEIs in these instances will contribute to the overall 
improvement in worker protection. However the user must recognize the 
constraint and limitations subject to their proper use and bear the 
responsibility for such use.
    ``The Introduction to the TLV/BEI book and the TLV/BEI 
Documentation provide the philosophical and practical basis for the 
uses and limitations of the TLVs and BEIs. To extend those uses of the 
TLVs and BEls to include other applications, such as use without the 
judgment of an industrial hygienist, application to a different 
population, development of new exposure/recovery time models, or new 
effect end points, stretches the reliability and even viability of the 
data-base for the TLV or BEI as evidence by the individual 
Documentations. It is not appropriate for individuals or organizations 
to impose on the TLVs or the BEIs their concepts of what the TLVs or 
BEls should be or how they should be applied or to transfer regulatory 
standards requirements to the TLVs or BEIs.''
    On the same page, ACGIH goes even further and in a special blocked 
paragraph with a title ``Special Note To User'' it is stated:
    ``The values listed in this book are intended for use in the 
practice of industrial hygiene as guidelines or recommendations to 
assist in the control of potential workplace health hazards and for no 
other use. These values are not fine lines between the safe and 
dangerous conditions and should not be used by anyone untrained in the 
discipline of industrial hygiene. It is imperative that the user of 
this book read the Introduction to each section and be familiar with 
the Documentation of the TLVs and BEIs before applying the 
recommendations contained herein. ACGIH disclaims liability with 
respect to the use of the TLVs and BEls.''
    The ``Policy Statement'' and ``Special Note to User'' listed above 
make it abundantly clear that ACGIH is not publishing the TLVs or BEIs 
as legal standards and that it is completely inappropriate for 
individuals or organizations to transfer regulatory standards 
requirements to the TLVs or BEIs. Thus the claim by Mr. Chajet or 
others that the TLVs or BEIs are standards published by ACGIH, is 
completely erroneous.
    ACGIH has made it abundantly clear that it publishes TLVs and 
BEIs as guidelines to assist the industrial hygienist in making 
workplace assessments of occupational exposures. As an example, if you 
are an industrial hygienist employed by a manufacturing company and you 
know that workers in the companys' plants are regularly exposed to a 
certain chemical, you can refer to the TLV/BEI Book and use the 
information provided as a reference point for making your individual 
decision as to what to recommend to the company. If you follow the 
specific instructions within the TLV/BEI Book you will obtain a copy of 
the Documentation for the substance involved and review that 
Documentation before making any recommendations,. You can then use the 
information provided as one part of the equation in making a 
determination of what is appropriate for a specific workplace 
situation.
    I have used the word ``Documentation'' in connection with the TLVs 
and the BEIs and I would like to explain exactly what I mean. For 
every TLV and BEI, ACGIH publishes a comprehensive scientific summary 
explaining the rationale for its action in establishing the TLV or 
BEI. The Documentation also contains a comprehensive list of the 
scientific literature relied upon in developing the TLVs or BEIs and 
an analysis of the major studies relied upon.
    Again, I emphasize that the TLVs and the BEIs are not developed 
for use in rulemaking proceedings or in standard setting activities. 
ACGIH does not submit the TLVs or the BEIs to any government agencies 
that are responsible for rulemakings or to any private organizations 
that are setting standards. The TLVs and the BEIs are guidelines 
designed to assist trained industrial hygienists in the control of 
workplace hazards.
    A second important concept to be understood is that the TLVs and 
the BEIs are not intended to show how dangerous a substance may be at 
various levels of exposure and should not be considered fine lines 
between hazardous and safe. These guidelines, in general terms, provide 
the opinion of ACGIH that nearly all workers may be repeatedly exposed 
to certain substances day after day without adverse health effects. The 
TLV represents a judgement, based on the available scientific 
literature or experience, that exposure at a certain level to a 
particular substance does not pose an unreasonable risk, and that the 
scientific literature and experience does not permit the same 
conclusion at a higher level of exposure.
    Mr. Chajet claims that the problem with the TLVs are that they are 
not supported by proper science and that they are prepared in secret. 
Neither of these allegations is true. As I will explain below, the TLVs 
are supported by the best peer reviewed science available. Further, the 
TLV process is an open process and not a secret process.
What is the Value of the TLVs/BEIs?
    ACGIH is proud to say the TLVs/BEls are recognized on a worldwide 
basis as one of, if not the best, compilations of occupational exposure 
guidelines and worker health and safety information. Even though ACGIH 
has repeatedly represented that these guidelines are not designed to be 
used as standards, thirteen countries use the TLVs as standards, and 
they are uniformly referenced in scientific literature in the 
development of worker safety and occupational health standards in many 
countries throughout the world. Scientists on a worldwide basis, in at 
least 62 countries, recognize the validity and excellence of ACGIH's 
science. But let me try to put that in perspective.
    In his testimony before this Subcommittee, Mr. Chajet indicates 
that one of his qualifications that enables him to make such a judgment 
is that he has served as an Associate Professor at the Johns Hopkins 
University School of Public Health. This is a very prestigious and very 
high ranking academic credential and would carry some weight--if it 
were true. In order to be an Associate Professor at Johns Hopkins 
University, you have to be appointed to the faculty in accord with 
established procedures for tenure-track professors. By contrast, Johns 
Hopkins also has ``Faculty Associates''. These are people invited to 
teach a specific course or lecture on a specific subject as a type of 
``Adjunct'' lecturer. These people need not have the qualifications 
necessary to become an Associate Professor. They are not on a tenure 
track. And they are certainly not entitled to represent that they are 
Associate Professors. Mr. Chajet served as a ``Faculty Associate'' not 
an Associate Professor at Johns Hopkins. Attached to this statement is 
a letter from the Assistant Dean of the Johns Hopkins University 
Bloomberg School of Hygiene and Public Health setting forth the fact 
that Mr. Chajet should not use the title of Associate Professor when 
describing his former relationship with the Johns Hopkins University.
    Now, let us look in detail at the procedure that ACGIH follows in 
adopting a TLV.
    ACGIH TLVs are established through a committee structure designed 
to involve independent scientists of multiple disciplines, include 
input from interested parties, and two levels of review. Further, after 
a proposed TLV has been prepared and the appropriate Documentation 
developed and made available to the public, the proposed TLV is put on 
the public ``Notice of Intended Changes'' (NIC) list for approximately 
one year or more. During that time, any interested party has the 
opportunity to submit additional information to the TLV Committee. All 
of the information submitted is carefully reviewed. At the end of a 
period of approximately one year, the TLV may be published in the 
original proposed form, published in a revised form with an additional 
NIC notice, maintained on the NIC list for an additional period of time 
in order to permit more information to be developed, or withdrawn. It 
is difficult to understand how anyone can claim that the process is a 
``secret'' process when a notice of any new TLV or any change in 
existing TLV is published approximately one year before it becomes an 
official recommendation of ACGIH effective.
    The ACGIH TLV Committee has approximately 30 members who represent 
4 major disciplines: Industrial Hygiene, Occupational Medicine, 
Occupational Epidemiology, and Toxicology. Members of ACGIH interested 
in joining the Committee are asked to complete a short application form 
and provide a resume or curriculum vitae. In evaluating any application 
for membership, the membership Subcommittee of the TLV Committee looks 
at the following criteria: disciplinary training and education, 
professional background, and past relevant experience. As a whole, it 
is expected that a majority of the Committee will have industrial 
hygiene expertise, with a majority of those having practical 
experience. The remainder of the Committee will be comprised of persons 
who have expertise in one or more of the following: occupational 
medicine, epidemiology, toxicology or other related specialties (e.g., 
statistics, chemistry, etc.). A preference will be given for 
individuals with ten or more years of professional experience and with 
advance degrees in their fields of expertise. Individual members of the 
Committee must demonstrate writing capabilities and communications 
skills through publications, presentations or other activities. It is 
expected that the membership of the Committee will reflect the 
demographics of the industrial hygiene and occupational health 
workforce. Persons with multi-disciplinary backgrounds and experience 
are encouraged to apply.
    Members of the TLV Committee are expected to contribute annually 
approximately four weeks of their time to the work of the Committee. 
This estimate includes time spent attending four meetings each year; 
time spent in preparing and reviewing TLV Documentations; and time 
spent in participating in Administrative Subcommittee activities. 
Senior members of the TLV Committee will also be expected to provide 
guidance and mentorship to the new members. Each member of the TLV 
Committee (with the exception of the Chair and the Vice-Chair) will be 
affiliated with one of the Chemical Substances Subcommittees. There are 
expectations that each member of a Chemical Substance Subcommittee will 
prepare at least two TLV Documentations annually; at least one of which 
should be for a new substance. In addition to Chemical Substance 
Subcommittee activities, each member of the TLV Committee is expected 
to actively participate on at least one other Administrative 
Subcommittee.
    I wish to emphasize that these Committees are not composed 
primarily of federal government employees out to write regulations 
without following the Administrative Procedures Act. The TLV Chemical 
Substances Committee is chaired by Lisa M. Brosseau, ScD, CIH of the 
University of Minnesota. The Vice-Chair is Laura E. Fleming, M.D., 
Ph.D., M.Ph. University of Miami. I am submitting a list of the current 
TLV Committee members with this Statement. The majority of the members 
of the Committee are affiliated with academic institutions. Although 
government employees from, for example, the Department of Labor and the 
National Institutes of Health certainly play an important role as 
Committee members, an equally important role is played by Committee 
members from such well known companies as Dow Chemical Company, Exxon 
Mobil, DuPont, and Merck & Co. Since 1970, the committee has consisted, 
on average, of 73% members from affiliations other than the federal 
government.
    The TLV Committee determines priorities based on an evaluation of 
what substances are commonly found in the workplace, what substances 
pose the greatest potential dangers, and what substances are produced 
to a great extent in the United States. Once a substance is identified 
as a substance that would be an appropriate subject for a TLV, the 
matter is put before the Committee leadership. With their approval, the 
appropriate Subcommittee will add the substance to its list of 
materials under study. The Subcommittee will take up the substance as 
soon as there is available manpower--a member of the Subcommittee will 
conduct a review of the literature and develop an initial draft of the 
Documentation. The initial author of the documentation is selected 
based on his or her special knowledge with reference to the substance 
involved. With the assistance of the ACGIH scientific staff and 
possibly paid outside consultants, the Subcommittee member assigned to 
the project collects information, assembles the information, evaluates 
the information, and then prepares a recommendation for consideration 
by the TLV Subcommittee.
    The proposed recommendation is accompanied by a comprehensive 
Documentation. The matter is reviewed by the Subcommittee and 
individual Subcommittee members comment on the proposed TLV level and 
the Documentation. The Subcommittee discusses the information 
available, the most appropriate scientific interpretation of the 
information, and whether or not the information is directly applicable 
to the workplace. Scientists from various disciplines provide their 
expertise. The initial preparer of the document may be asked to further 
review or redraft the recommendation and the Documentation, which is 
then submitted to the subcommittee for additional review discussion and 
recommendation. Once the Subcommittee reaches a decision, the initial 
Documentation and recommendation are prepared in a form for submission 
to the full TLV Committee. Again, each member of the TLV Committee gets 
a copy of the proposed TLV together with the Documentation. The full 
Committee may accept the recommendation or recommend that the 
Subcommittee again review its findings.
    If the full Committee recommends that the Subcommittee-proposed TLV 
be approved, the matter is forwarded to the ACGIH Board of Directors. 
If the recommendation is ratified by the ACGIH Board of Directors, it 
is then posted on the Notice of Intended Change List for approximately 
one year. During that time period, comments are invited from all 
interested parties, including producers, users, etc of the substance. 
It is important to note that the Subcommittee developing a TLV for any 
substance welcomes producers and users of that substance to submit 
occupational health and industrial hygiene data and comments. ACGIH 
regularly publishes information about what substances are being 
considered for possible TLVs by the TLV Committee. The TLV 
Subcommittees considering specific substances are composed of 
volunteers and have only a limited amount of time to meet. Therefore, 
except in unusual circumstances, interested parties are requested to 
submit information to the Subcommittees and the full Committee in 
writing. The Subcommittees are interested in reviewing any and all 
relevant scientific studies that have been conducted in accord with 
recognized scientific protocols. The Subcommittees generally will not 
consider data that has not been obtained and prepared in accord with 
accepted scientific methodologies. It is not uncommon for the TLV 
Committee or the Subcommittees to get requests from interested parties 
to make an oral presentation. However, such requests are generally 
denied as the committee has found that such oral presentations are much 
less persuasive than sound scientific studies and can take up limited 
meeting time necessary for thorough discussions. The Committee has 
invited researchers to discuss their findings with them, however, from 
time to time.
    In Mr. Chajet's testimony, he expresses concern that the TLVs had 
once been submitted to the entire ACGIH membership for ratification 
whereas now the report of the TLV Committee is submitted to the Board 
of Directors for ratification. He implies that the decision by the 
Board is in some way less democratic and more autocratic then the 
decision by the entire membership. In fact, few ACGIH members attend 
the annual Business Meeting of the Association. Typically, 
approximately 65 out of 4,200 members have attended that meeting. When 
the TLVs were presented for a vote at the Annual Meeting, each member 
was provided with the recommendation of the TLV Committee and the 
members could vote Yes or No. In all instances, the members voted to 
approve the recommendation of the Committee. Although members certainly 
could have reviewed the Documentations if they had chosen to do so, 
very few did review such Documentations. The ACGIH Board was concerned 
that this perfunctory review by the membership served no actual 
purpose. The Board felt it would be more responsible to provide a level 
of review by the Board of Directors. Each member of the Board has 
specific information with regard to the proposed TLVs and access to the 
proposed Documentations. In addition, a member of the Board of 
Directors serves as a liaison with the TLV Committee and can report to 
the Board with regard to the deliberations at the Committee and 
Subcommittee levels. With regard to the allegations that there are no 
minutes at the Subcommittee and Committee levels, these allegations 
again are untrue. The Committee and the Subcommittees do keep minutes.
    Although ACGIH has long had a conflict of interest policy, that 
policy was based on the concept of members of Committees, 
Subcommittees, and the Board of Directors voluntarily disclosing 
conflicts of interest or biases when such existed. Recently, in 
September 2000, ACGIH adopted a formal conflict of interest policy. 
This policy is modeled after the policy followed by the National 
Academy of Sciences. Members of the Board and the TLV Committee and 
Subcommittees are required to disclose all conflicts of interest and 
sign a written form on an annual basis acknowledging that they have 
read the ACGIH policy on conflicts of interest and biases and that they 
have agreed to fully comply with that policy.
    As an industrial hygienist who often consults with industry, I am 
well aware of issues involving the practicality of applying a set of 
guidelines such as the TLVs. Other major issues that must be considered 
by industry include cost and technical feasibility. Reducing workplace 
exposure levels is not something that can be typically accomplished 
instantaneously. Reduction involves the expenditure of funds and an 
evaluation of numerous possible control options with varying degrees of 
technical feasibility. As a result, implementation of control options 
in a workplace with multiple chemical and physical hazards requires 
careful consideration of costs and benefits as well as engineering 
feasibility.
    These are complex issues that create pressures that government 
agencies such as OSHA and MSHA must deal with in a regulatory arena . 
When Congress drafted legislation such as the Occupational Safety and 
Heath Act, Congress included within the confines of the statue 
requirements related to economic efficiency and the availability of 
reasonable control technologies. By contrast, ACGIH TLVs and BEls have 
no such limitations. ACGIH TLVs and BEIs are designed solely on the 
basis of worker health and safety issues. Individual industries are 
free to use these guidelines within their own specific health and 
safety programs with due consideration to aspects of cost and 
feasibility. ACGIH TLVs and BEls state that if a worker is exposed to a 
certain substance at a level of ``X'' amount or less, the worker does 
not have an unreasonable risk of injury. This level is determined 
regardless of the cost of achieving that level of exposure. The level 
is determined regardless of whether technology exists to reduce 
exposure to that level. Because the ACGIH does not consider factors 
such as economic and technological feasibility, the TLVs and BEls do 
not meet the criteria placed on most government agencies that set 
standards. Therefore, ACGIH does not recommend the TLVs and the BEIs be 
used as legal standards. ACGIH specifically says in its Policy 
Statement that these guidelines are developed for the use by industrial 
hygienists in their normal workplace activities.
    Should federal government scientists be allowed to participate in 
ACGIH activities? Absolutely! Government lawyers participate in the 
American Bar Association activities. ABA Committees, including 
government representatives, routinely publish papers analyzing court 
decisions and agency regulations. Government physicians who are members 
of the American Medical Association, routinely participate on AMA 
Committees that publish information with regard to the public health. 
Governmental industrial hygienists are no different from government 
lawyers and government doctors. They should be allowed to participate 
in the activities of a scientific society such as ACGIH as long as 
participation in such activities does not violate the conflict of 
interest policies established by the various agencies for which they 
work and/or the ACGIH Conflict of Interest Policy.
    One final point, as a scientist with over 25 years of conducting 
research, I strongly disagree with Mr. Chajet's allegation that there 
is a lack of scientific justification for certain of ACGIH's TLVs. I am 
submitting with this Statement copies of the ACGIH TLVs for Benzene and 
Formaldehyde. I ask that the Committee review these Documentations 
which are typical of the Documentation for substances covered by a TLV 
or BEI. I am sure that you will find that the science supporting this 
Documentation meets the highest standards and provides an ample basis 
for supporting the position taken. I submit the Benzene TLV because 
this TLV is an example of how the TLVs are addressed as new scientific 
evidence becomes available. The TLV for Benzene was 100 PPM in 1945. It 
was lowered to 50 PPM in 1946, to 35 PPM in 1949, to 25 PPM in 1957, to 
10 PPM in 1963, and thereafter to 0.5 PPM in 1997. Unfortunately, in 
some cases ACGIH is presented with concerns about a substance for which 
there is little scientific data. In these cases the TLV committee may 
make a conservative judgement about a TLV. This is not a question of 
scientific justification but rather a safety judgement on the part of 
ACGIH about what is prudent in the face of scientific uncertainty. 
Finally, Mr. Chajet accuses ACGIH of risking its reputation by failing 
to solve structural problems. ACGIH, as any scientific organization, 
encourages discussion, encourages expressions of new and varying ideas, 
and encourages expressions of opposite viewpoints. Within its various 
Committees, ACGIH has followed these precepts and as a result, there 
are instances where discussions with regard to many issues are heated 
and adversarial. These types of discussions only result in a better 
review and an end product that more accurately reflects the state of 
the art. To encourage these types of discussions and avoid even the 
appearances of impropriety, the ACGIH members amended the Bylaws almost 
a year ago to permit industrial hygienists working for industry to have 
a full voting active membership in the Association on the same status 
of industrial hygienists working for academic institutions or federal, 
state or local governmental agencies. The ACGIH Board of Directors 
recently adopted a more comprehensive conflict of interest and bias 
policy as I described above. ACGIH has an extensive website which 
includes scientific literature available to persons throughout the 
world through the use of the world wide web. The data we rely on is 
open and available Our process is open. ACGIH publishes notification of 
the substances that are under investigation by the TLV Committee so 
that all interested parties are aware of the substances under 
consideration. ACGIH publishes proposed TLVs and BEIs a year before the 
TLVs or BEIs become effective so that all interested parties have ample 
opportunity to comment and submit data. We encourage input from any and 
all parties. We never publish a TLV or BEI without a full and 
comprehensive Documentation. We tell the world that TLVs and BEIs are 
only guidelines and should not be used as standards.
    As Mr. Chajet has stated in his testimony: The ACGIH name and the 
TLV trademark are recognized and respected around the world, based on a 
50 year history of advancing the heath protection of the workforce.'' 
There is no reason that this Committee should deny a government 
employee the right to participate in ACGIH activities if that employee 
follows the rules and regulations of his or her respective agency.
    ACGIH thanks you for this opportunity to present this Statement. If 
you have any further questions with regard to ACGIH, please contact me 
and I will be glad to provide answers to your inquiries.
                                 ______
                                 
               School of Hygiene and Public Health,
                                  Johns Hopkins University,
                                      Baltimore, MD, June 21, 2001.
Mr. Steven John Fellman,
Galland, Kharasch, Greenberg, Fellman and Swirsky, Washington, DC.
    Dear Mr. Fellman: I would like to advise you that Mr. Henry Chajet 
held the part-time faculty title of ``Associate'' in the Department of 
Environmental Health Sciences of the Johns Hopkins Bloomberg School of 
Public Health (formerly the Johns Hopkins School of Hygiene and Public 
Health.) He held the title from January 1984 through June 2000. In that 
capacity, Mr. Chajet was co-instructor (with Mr. David Blum) of an 8-
week course entitled ``Occupational Safety and Health Law'' that was 
taught annually.
    Mr. Chajet has never held the title of ``Associate Professor of 
Safety and Health Law'' at the School of Public Health.
    Please contact me with any questions.
            Sincerely,
                                           Robin Fox, M.S.,
                               Assistant Dean for Academic Affairs.
                                 ______
                                 
                                   ACGIH Worldwide,
                                  1330 Kemper Meadow Drive,
                                  Cincinnati, OH, January 15, 2002.
James A. Bair,
Vice President, North American Millers' Association, 1600 Maryland 
        Avenue, SW, Washington, DC.

Robb S. MacKie, II,
Vice President, Government Relations, American Bakers Association, 1350 
        I Street, NW, Washington, DC.
    Dear Jim and Robb: ACGIH has reviewed your request that it clarify 
its position on the use of Threshold Limit Values (TLVs), prepare a 
substantive response to the SOMA Report, and put the TLV for Flour Dust 
back on the Notice of Intended Changes (NIC).
    Enclosed is a new statement of position regarding the use of the 
TLVs. This statement clearly communicates ACGIH's position that TLVs 
are not to be used as standards by government agencies or other 
organizations. We are sending a copy of this statement to the Canadian 
authorities listed in Mr. Harrison's letter of January 4, 2002 
addressed to ACGIH, and are posting this statement on the ACGIH website 
and publishing it in our newsletter, Today!. We have met with OSHA and 
provided that agency with a copy of this statement. We would be glad to 
send additional copies of this statement to state regulatory officials. 
If you have names and addresses of such persons that should get copies 
of the statement please provide them to us.
    Also enclosed is the ACGIH analysis of the SOMA Report. This 
analysis was done by the TLV Committee and reviewed and approved by the 
ACGIH Board of Directors. Although neither the TLV Committee nor the 
Board of Directors believes that the SOMA Report provides a basis to 
put the Flour Dust TLV back on the NIC, ACGIH is always willing to look 
at new peer-reviewed literature. If any new peer-reviewed literature 
regarding Flour Dust is brought to ACGIH's attention, you can be sure 
that the TLV Committee will give full consideration to any new data, 
and then recommend whatever revisions it believes are appropriate to 
the TLV.
    In conclusion, based upon the enclosed analysis, ACGIH has decided 
to retain the adopted TLV for Flour Dust and to not put it back on the 
NIC for 2002. It is our desire to maintain open lines of communication 
between ACGIH and the baking and milling industries. Should new peer-
reviewed literature become available, please do not hesitate to bring 
it to our attention. The TLVs are not carved in stone. ACGIH is always 
willing to review and consider new peer-reviewed literature. Further, 
we would be glad to work with you to ensure the message on the 
appropriate use of the TLVs is communicated to the proper individuals 
and officials. Simply provide us with a list of names and addresses, 
and we will send them a copy of the ACGIH position statement on the use 
of TLVs.
    Please do not hesitate to contact Steve Fellman or me if you have 
any questions.
            Sincerely,
                                        A. Anthony Rizzuto,
                                                Executive Director.
                                 ______
                                 
                                   ACGIH Worldwide,
                                  1330 Kemper Meadow Drive,
                                  Cincinnati, OH, January 15, 2002.
Gordon Harrison,
President, Canadian National Millers Association 90 Sparks Street, 
        Ottawa, Ontario, Canada.

Paul Hetherington,
President and CEO, Baking Association of Canada, 7895 Tranmere Drive, 
        Mississauga, Ontario, Canada.
    Dear Gordon and Paul: ACGIH has reviewed your request that it 
clarify its position on the use of Threshold Limit Values (TLVs), 
prepare a substantive response to the SOMA Report, and put the TLV for 
Flour Dust back on the Notice of Intended Changes (NIC).
    Enclosed is a new statement of position regarding the use of the 
TLVs. This statement clearly communicates ACGIH's position that TLVs 
are not to be used as standards by government agencies or other 
organizations. We are sending a copy of this statement to the Canadian 
authorities listed in Mr. Harrison's letter of January 4, 2002 
addressed to ACGIH, and are posting this statement on the ACGIH website 
and publishing it in our newsletter, Today!. We have met with OSHA and 
provided that agency with a copy of this statement. We would be glad to 
send additional copies of this statement to state regulatory officials. 
If you have names and addresses of such persons that should get copies 
of the statement please provide them to us.
    Also enclosed is the ACGIH analysis of the SOMA Report. This 
analysis was done by the TLV Committee and reviewed and approved by the 
ACGIH Board of Directors. Although neither the TLV Committee nor the 
Board of Directors believes that the SOMA Report provides a basis to 
put the Flour Dust TLV back on the NIC, ACGIH is always willing to look 
at new peer-reviewed literature. If any new peer-reviewed literature 
regarding Flour Dust is brought to ACGIH's attention, you can be sure 
that the TLV Committee will give full consideration to any new data, 
and then recommend whatever revisions it believes are appropriate to 
the TLV.
    In conclusion, based upon the enclosed analysis, ACGIH has decided 
to retain the adopted TLV for Flour Dust and to not put it back on the 
NIC for 2002. It is our desire to maintain open lines of communication 
between ACGIH and the baking and milling industries. Should new peer-
reviewed literature become available, please do not hesitate to bring 
it to our attention. The TLVs are not carved in stone. ACGIH is always 
willing to review and consider new peer-reviewed literature. Further, 
we would be glad to work with you to ensure the message on the 
appropriate use of the TLVs is communicated to the proper individuals 
and officials. Simply provide us with a list of names and addresses, 
and we will send them a copy of the ACGIH position statement on the use 
of TLVs.
    Please do not hesitate to contact Steve Fellman or me if you have 
any questions.
                                        A. Anthony Rizzuto,
                                                Executive Director.
                                 ______
                                 
                                   ACGIH Worldwide,
                                  1330 Kemper Meadow Drive,
                                  Cincinnati, OH, January 15, 2002.
James A. Bair,
Vice President, North American Millers' Association, 1600 Maryland 
        Avenue, SW, Washington, DC.

Robb S. MacKie, II,
Vice President, Government Relations, American Bakers Association, 1350 
        I Street, NW, Washington, DC.

Gordon Harrison,
President, Canadian National Millers Association 90 Sparks Street, 
        Ottawa, Ontario, Canada.
    Dear Sirs: The TLV Committee expresses its thanks, again, for your 
comments on the Flour Dust TLV Documentation. Your input is 
appreciated.
    The Committee has reviewed the August 2000 report prepared by 
Sandler Occupational Medicine Associates, Inc. (SOMA) for the North 
American Millers' Association, American Bakers Association, and 
Canadian National Millers Association. Some of the materials reviewed 
by SOMA were not included in the initial TLV Documentation, because 
they were published after the Documentation was prepared. The Committee 
has incorporated these references into the Documentation, where 
appropriate. Thank you for calling these to our attention.
    The Committee does not usually respond directly, or in detail, to 
the comments it receives, because its opinions are reflected solely in 
its written Documentation. Rather, the Committee reviews all such 
comments and makes changes to its written Documentation, as 
appropriate. In the case of the Flour Dust TLV Documentation, in 
addition to including new references, the TLV recommendation section 
was re-written to further explain which studies and issues played a key 
role in the committee's decision to recommend a TLV of 0.5 mg/m3. You 
will note that the rewritten Documentation includes specific emphasis 
on the studies by Hartmann et al. (1985 and 1986), Awad el Karim et al. 
(1986), Musk et al. (1989), De Zotti et al. (1994), Cullinan et al. 
(1994 and 2001), Bohadana et al. (1994), Massin et al. (1995), 
Shamssain (1995), Gimenez et al. (1995), and Zuskin et al. (1998), as 
well as studies relied upon in the original Documentation.
    The Committee has agreed, contrary to its usual practice, to 
respond to comments expressed in the report prepared by SOMA. Our 
responses are directed to the three specific issues raised in the SOMA 
report.
1. Sensitization As An End-Ppoint
    The SOMA report argues that sensitization should not be the health 
end-point of concern, because there is a low correlation between 
respiratory symptoms and skin or immunoassay tests. On the other hand, 
the SOMA report readily admits that bakers' asthma and respiratory 
sensitization are well-known health endpoints resulting from exposure 
to airborne Flour Dust. It also recognizes that respiratory symptoms 
may occur due to irritation effects of the dust. The report concludes 
that, if sensitization is of importance, it is likely to occur at 
airborne levels lower than levels at which respiratory symptoms due to 
irritation will occur.
    The TLV Committee is not persuaded by the argument that a low 
correlation of skin or immunoassay tests with symptoms means that 
sensitization is a health end-point that should be ignored. A 
preponderance of the data ranging from human case reports to 
epidemiologic studies points to this end-point as one of importance. 
The TLV Committee would be remiss in its mission to guide industrial 
hygienists if it were to conclude that sensitization is an unimportant 
health end-point, simply because the data are confounded by the effects 
of irritation and the relative non-specificity of current health 
outcome measures. Sensitization can result in debilitating disease that 
can lead, eventually, to an inability to work.
    Furthermore, the SOMA report suggests that:
    1. ``Research in this area as reported by many independent studies 
has found that sensitization to Flour Dust does not account for a 
majority of reported symptoms in flour workers.''
and
    2. ``The position of the ACGIH document, that sensitization is the 
chief health outcome of concern, is, therefore, not supported by the 
scientific evidence.''
    TLVs are set based on the most significant health threat associated 
with exposure to a given chemical. For example, the TLV for benzene is 
set based on its carcinogenic potential, not its CNS effects. Deciding 
which health outcome is the most significant requires more than an 
analysis of what effect occurs most commonly. The medical consequences 
associated with the health outcome are also considered. In the case of 
Flour Dust, sensitization and the manifestation of allergic/asthma 
symptoms is a more significant outcome than simple irritation. As a 
result, the Committee believes this to be the most important health 
end-point of concern for this substance.
    The SOMA report notes that there are flour additives that can cause 
allergy. The TLV Committee agrees and discusses this issue in its 
Documentation. However, it is clear that materials inherent to Flour 
Dust (proteins, enzymes, etc.) can be both sensitizing and irritating. 
Thus, the Committee has chosen to address Flour Dust as a single 
substance. It has indicated its interest in developing separate TLVs 
for some of the allergenic additives (such as alpha amylase), as well.
2. Study Criteria
    We agree with the SOMA report that there are many shortcomings in 
the currently available literature. We agree that the data are limited 
and that there is no particular study, including that by Houba (1998), 
which points conclusively to a specific threshold of exposure below 
which sensitization will not occur. The TLV recommendation section in 
the Documentation was re-written to demonstrate that a number of 
studies, including those listed above, point to the recommended TLV.
    The Committee does not make its decisions in the manner suggested 
by the SOMA report--by eliminating studies from its consideration when 
they do not meet the high standards described. Rather, the Committee 
evaluates each study carefully, taking into consideration both 
strengths and weaknesses. The Committee considers all of the literature 
together, and if it finds that there is a preponderance of evidence for 
a particular health effect, it makes its best effort to determine the 
level below which it is likely that that health effect will not occur. 
The Committee strives to select the health effect(s) of greatest 
significance to the long-term health of employees.
    As noted above, the Committee welcomes comments on its written 
Documentation. However, the Committee suggests, respectfully, that to 
exclude or include certain studies solely on the basis of sets of 
criteria is unduly restrictive. Such an approach reflects a difference 
in opinion, rather than a matter of scientific understanding, and would 
result in the elimination of data that could be significant. The 
Documentation developed by the TLV Committee represents an opinion 
about data that are available in the peer-reviewed, published 
literature. Other parties are welcome to publish their own opinions 
about these data, which may differ from those of the Committee. We 
encourage SOMA to publish its report to make it available to the 
scientific community for broader inclusion in public discussions about 
Flour Dust health effects.
3. Exposure Threshold
    The TLV Committee agrees with the SOMA report that a ``threshold 
based upon sensitization is likely to be considerably lower than one 
based upon prevention of non-allergic (e.g. irritant) effects.'' Since 
the Committee is persuaded by its review of the literature that 
sensitization is a key health end-point for this substance, it has 
sought to find a level for airborne Flour Dust below which nearly all 
workers are unlikely to develop sensitization. This level should 
provide assurance, as well, that exposures will not lead to respiratory 
symptoms resulting from respiratory tract irritation.
    The TLV Committee has not relied solely on the Houba (1998) study 
for its recommendation of a TLV at 0.5 mg/m3. Rather, it has concluded 
from its review of a number of studies (listed above), and in 
particular those by Musk et al. (1989), Cullinan et al. (1994 and 
2001), and Houba et al. (1996), listed in the TLV Recommendation 
section of the Documentation, that the TLV should be less than 1 mg/m3. 
The Committee has elected to recommend a level of 0.5 mg/m3.
    Again, we thank the North American Millers' Association, American 
Bakers Association, and Canadian National Millers Association for their 
input on the TLV Documentation for Flour Dust. Changes were made to the 
Documentation to elucidate some of the issues raised and to include new 
references. We hope that this letter will serve to explain why the SOMA 
report did not persuade the Committee to remove this substance from its 
list of adopted values or to place this substance back on its list of 
substances and issues under study.
            Sincerely,
                                     Lisa M. Brosseau, ScD,
                          Chair, TLV Chemical Substances Committee.
                                 ______
                                 

          Statement of Position Regarding the TLVs and BEIs*

    The American Conference of Governmental Industrial Hygienists 
(ACGIH) is a private not-for-profit, nongovernmental corporation whose 
members are industrial hygienists and other occupational health and 
safety professionals dedicated to promoting health and safety within 
the workplace. ACGIH is a scientific association. ACGIH is not a 
standard setting body. As a scientific organization, it has established 
committees that review existing published, peer-reviewed scientific 
literature. ACGIH proposes guidelines known as Threshold Limit Values 
(TLVs) and Biological Exposure Indices (BEIs) for use by industrial 
hygienists in making decisions regarding safe levels of exposure to 
various chemical and physical agents found in the workplace. In using 
these guidelines, industrial hygienists are cautioned that the TLVs and 
BEIs are only one of multiple factors to be considered in evaluating 
specific workplace situations and conditions.
    Each year ACGIH publishes its TLVs and BEIs in a book. In the 
introduction to the book, ACGIH specifically states that the TLVs and 
BEIs are guidelines to be used by professionals trained in the practice 
of industrial hygiene. The TLVs and BEIs are not designed to be used as 
standards. Nevertheless, ACGIH is aware that in certain instances the 
TLVs and the BEIs are used as standards by national governments, state 
governments, and local governments.
    Governmental bodies establish public health standards based on 
statutory and legal frameworks that include definitions and criteria 
concerning the approach to be used in assessing and managing risk. In 
most instances, governmental bodies that set workplace health and 
safety standards are required to evaluate health effects, economic and 
technical feasibility, and the availability of acceptable methods to 
determine compliance with the proposed standard.
    ACGIH TLVs and BEIs are solely health-based values. ACGIH TLVs and 
BEIs are established by committees that review existing published and 
peer-reviewed literature in various scientific disciplines (e.g., 
industrial hygiene, toxicology, occupational medicine, and 
epidemiology). Based on the available information, ACGIH formulates a 
conclusion on the level of exposure that the typical worker can 
experience without an unreasonable risk of disease or injury. The TLV 
and BEI are not quantitative estimates of risk at different exposure 
levels or by different routes of exposure.
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    *ACGIH is publishing this Statement in order to assist ACGIH 
members, government regulators, and industry groups in understanding 
the basis and limitations of the TLVs and BEIs when used in a 
regulatory context. This Statement was adopted by the ACGIH Board of 
Directors on January 11, 2002.
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    Since ACGIH TLVs and BEIs are based solely on health factors, there 
is no consideration given to economic or technical feasibility. 
Regulatory agencies should not assume that it is economically or 
technically feasible for an industry or employer to meet TLVs or BEIs. 
Similarly, although there are usually valid methods to measure 
workplace exposures at TLVs and BEIs, there can be instances where such 
reliable test methods have not yet been validated. Obviously, such a 
situation can create major enforcement difficulties if a TLV or BEI was 
adopted as a standard.
    ACGIH does not believe that TLVs and BEIs should be adopted as 
standards without an analysis of other factors necessary to make 
appropriate risk management decisions (e.g., control options, technical 
and economic factors, etc.). However, ACGIH does believe that 
regulatory bodies should certainly consider TLVs or BEIs as valuable 
input into the risk characterization process (hazard identification, 
dose-response relationships, and exposure assessment). Regulatory 
bodies should view TLVs and BEIs as an expression of scientific 
opinion.
    ACGIH is proud of the scientists and the many members who volunteer 
their time to work on the TLV and BEI Committees. These experts develop 
written Documentation that include an expression of scientific opinion 
and a description of the basis, rationale, and limitations of the 
conclusions reached by ACGIH. The Documentation provides a 
comprehensive list and analysis of all the major published peer-
reviewed studies that ACGIH relied upon in formulating its scientific 
opinion. Regulatory agencies dealing with hazards addressed by a TLV or 
BEI should obtain a copy of the full written Documentation for the TLV 
or BEI. Any use of a TLV or BEI in a regulatory context should include 
a careful evaluation of the information in the written Documentation 
and consideration of all other factors required by statute under the 
regulatory procedures of the governmental body involved.
     ACGIH is a not-for-profit scientific association.
     ACGIH proposes guidelines known as TLVs and BEIs for use 
by industrial hygienists in making decisions regarding safe levels of 
exposure to various hazards found in the workplace.
     ACGIH is not a standard setting body.
     Regulatory bodies should view TLVs and BEIs as an 
expression of scientific opinion.
     ACGIH TLVs and BEIs are based solely on health factors; 
there is no consideration given to economic or technical feasibility. 
Regulatory agencies should not assume that it is economically or 
technically feasible to meet established TLVs or BEIs.
     ACGIH believes that TLVs and BEIs should NOT be adopted as 
standards without an analysis of other factors necessary to make 
appropriate risk management decisions.
     TLVs and BEIs can provide valuable input into the risk 
characterization process. Regulatory agencies dealing with hazards 
addressed by a TLV or BEI should review the full written documentation 
for the numerical TLV or BEI.
                                 ______
                                 
    [Additional court order submission from Mr. Owens follows:]

    [Submitted and placed in permanent archive file, Court Order, 
International Brominated Solvents Association v. American Conference of 
Governmental Hygienists, Inc., No. 5:04CV394 (D.M.D. Ga., 2005).]

                                 
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