[House Report 110-239]
[From the U.S. Government Publishing Office]



110th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 1st Session                                                    110-239

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



 
              POPCORN WORKERS LUNG DISEASE PREVENTION ACT

                                _______
                                

 July 18, 2007.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

 Mr. George Miller of California, from the Committee on Education and 
                     Labor, submitted the following

                              R E P O R T

                             together with

                             MINORITY VIEWS

                        [To accompany H.R. 2693]

      [Including cost estimate of the Congressional Budget Office]

  The Committee on Education and Labor, to whom was referred 
the bill (H.R. 2693) to direct the Occupational Safety and 
Health Administration to issue a standard regulating worker 
exposure to diacetyl, having considered the same, report 
favorably thereon with an amendment and recommend that the bill 
as amended do pass.

  The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``Popcorn Workers Lung Disease 
Prevention Act''.

SEC. 2. FINDINGS.

  Congress finds the following:
          (1) An emergency exists concerning worker exposure to 
        diacetyl, a substance used in many flavorings, including 
        artificial butter flavorings.
          (2) There is compelling evidence that diacetyl presents a 
        grave danger and significant risk of life-threatening illness 
        to exposed employees. Workers exposed to diacetyl have 
        developed, among other conditions, a debilitating lung disease 
        known as bronchiolitis obliterans.
          (3) From 2000-2002 NIOSH identified cases of bronchiolitis 
        obliterans in workers employed in microwave popcorn plants, and 
        linked these illnesses to exposure to diacetyl used in butter 
        flavoring. In December 2003, NIOSH issued an alert ``Preventing 
        Lung Disease in Workers Who Use or Make Flavorings,'' 
        recommending that employers implement measures to minimize 
        worker exposure to diacetyl.
          (4) In August 2004 the Flavor and Extract Manufacturers 
        Association of the United States issued a report, ``Respiratory 
        Health and Safety in the Flavor Manufacturing Workplace,'' 
        warning about potential serious respiratory illness in workers 
        exposed to flavorings and recommending comprehensive control 
        measures for diacetyl and other ``high priority'' substances 
        used in flavoring manufacturing.
          (5) From 2004-2007 additional cases of bronchiolitis 
        obliterans were identified among workers in the flavoring 
        manufacturing industry by the California Department of Health 
        Services and Division of Occupational Safety and Health (Cal/
        OSHA), which through enforcement actions and an intervention 
        program called for the flavoring manufacturing industry in 
        California to reduce exposure to diacetyl.
          (6) In a report issued in April 2007, NIOSH reported that 
        flavor manufacturers and flavored-food producers are widely 
        distributed in the United States and that bronchiolitis 
        obliterans had been identified among microwave popcorn and 
        flavoring-manufacturing workers in a number of States.
          (7) Despite NIOSH's findings of the hazards of diacetyl and 
        recommendations that exposures be controlled, and a formal 
        petition by labor organizations and leading scientists for 
        issuance of an emergency temporary standard, the Occupational 
        Safety and Health Administration (OSHA) has not acted to 
        promulgate an occupational safety and health standard to 
        protect workers from harmful exposure to diacetyl.
          (8) An OSHA standard is urgently needed to protect workers 
        exposed to diacetyl from bronchiolitis obliterans and other 
        debilitating conditions.

SEC. 3. ISSUANCE OF STANDARD ON DIACETYL.

  (a) Interim Standard.--
          (1) Rulemaking.--Notwithstanding any other provision of law, 
        not later than 90 days after the date of enactment of this Act, 
        the Secretary of Labor shall promulgate an interim final 
        standard regulating worker exposure to diacetyl. The interim 
        final standard shall apply--
                  (A) to all locations in the flavoring manufacturing 
                industry that manufacture, use, handle, or process 
                diacetyl; and
                  (B) to all microwave popcorn production and packaging 
                establishments that use diacetyl-containing flavors in 
                the manufacture of microwave popcorn.
          (2) Requirements.--The interim final standard required under 
        subsection (a) shall provide no less protection than the 
        recommendations contained in the NIOSH Alert ``Preventing Lung 
        Disease in Workers Who Use or Make Flavorings'' (NIOSH 
        Publication 2004-110) and include the following:
                  (A) Requirements for engineering, work practice 
                controls, and respiratory protection to minimize 
                exposure to diacetyl. Such engineering and work 
                practice controls include closed processes, isolation, 
                local exhaust ventilation, proper pouring techniques, 
                and safe cleaning procedures.
                  (B) Requirements for a written exposure control plan 
                that will indicate specific measures the employer will 
                take to minimize employee exposure; and requirements 
                for evaluation of the exposure control plan to 
                determine the effectiveness of control measures at 
                least on a biannual basis and whenever medical 
                surveillance indicates abnormal pulmonary function in 
                employees exposed to diacetyl, or whenever necessary to 
                reflect new or modified processes.
                  (C) Requirements for airborne exposure assessments to 
                determine levels of exposure and ensure adequacy of 
                controls.
                  (D) Requirements for medical surveillance for workers 
                and referral for prompt medical evaluation.
                  (E) Requirements for protective equipment and 
                clothing for workers exposed to diacetyl.
                  (F) Requirements to provide written safety and health 
                information and training to employees, including hazard 
                communication information, labeling, and training.
          (3) Effective date of interim standard.--The interim final 
        standard shall take effect upon issuance. The interim final 
        standard shall have the legal effect of an occupational safety 
        and health standard, and shall apply until a final standard 
        becomes effective under section 6 of the Occupational Safety 
        and Health Act (29 U.S.C. 655).
  (b) Final Standard.--Not later than 2 years after the date of 
enactment of this Act, the Secretary of Labor shall, pursuant to 
section 6 of the Occupational Safety and Health Act (29 U.S.C. 655), 
promulgate a final standard regulating worker exposure to diacetyl. The 
final standard shall contain, at a minimum, the worker protection 
provisions in the interim final standard, a short term exposure limit, 
and a permissible exposure limit that does not exceed the lowest 
feasible level, and shall apply at a minimum to all facilities where 
diacetyl is processed or used.

SEC. 4. STUDY AND RECOMMENDED EXPOSURE LIMITS ON OTHER FLAVORINGS.

  (a) Study.--The National Institute of Occupational Safety and Health 
shall conduct a study on food flavorings used in the production of 
microwave popcorn. The study shall prioritize the chemicals that are 
most closely chemically associated with diacetyl to determine possible 
exposure hazards. NIOSH shall transmit a report of the findings of the 
study to the Occupational Safety and Health Administration.
  (b) Recommended Exposure Limits.--Upon completion of the study 
conducted pursuant to subsection (a), NIOSH shall establish recommended 
exposure limits for flavorings determined by such study to pose 
exposure hazards to workers involved in the production of microwave 
popcorn.

                               I. PURPOSE

    The purpose of this legislation is to direct the 
Occupational Safety and Health Administration to issue a 
standard regulating worker exposure to diacetyl, an artificial 
chemical butter flavoring product that has been shown to cause 
serious lung disease called bronchiolitis obliterans, also 
known as ``popcorn lung.'' While the first cases of popcorn 
lung were identified in a Missouri microwave popcorn plant in 
2000 and the disease was linked to diacetyl shortly thereafter, 
the Occupational Safety and Health Administration has not taken 
any significant action to prevent worker exposure to diacetyl.

    II. COMMITTEE ACTION INCLUDING LEGISLATIVE HISTORY AND VOTES IN 
                               COMMITTEE

Action in previous Congresses

    There was no action on diacetyl in previous Congresses.

                             110th Congress


Hearing on ``Have OSHA standards kept up with workplace hazards?''

    On April 24, 2007, the Workforce Protections Subcommittee, 
led by chairwoman Lynn Woolsey (D-CA), conducted an oversight 
hearing titled ``Have OSHA Standards Kept up With Workplace 
Hazards?'' in order to address the lack of OSHA standards 
issued over the past six years. The witnesses discussed the 
obstacles to issuing OSHA standards, opportunities to speed up 
the process and the human cost of failing to issue needed 
protective standards. Witnesses included Assistant Secretary of 
Labor Edwin Foulke, Scott Schneider Director of Occupational 
Safety and Health for the Laborers' Health and Safety Fund of 
North America, Frank Mirer, PhD, Professor of Environmental and 
Occupational Health Sciences, Hunter School of Urban Public 
Health, New York, Baruch Fellner an attorney at Gibson, Dunn 
and Crutcher, and Eric Peoples, a former employee of Glister-
Mary Lee popcorn factory, victim of bronchiolitis obliterans 
(popcorn lung).

Introduction of H.R. 2693, the ``Popcorn Workers Lung Disease 
        Prevention Act''

    On June 13, 2007, the Popcorn Workers Lung Disease 
Prevention Act, as H.R. 2693, was introduced in the 110th 
Congress by Representative Lynn Woolsey, joined by 13 original 
co-sponsors, including Chairman George Miller (D-CA) as a lead 
co-sponsor.

Full Committee markup of H.R. 2963

    On June 20, 2007 the Committee on Education and Labor met 
to markup H.R. 2693, Popcorn Workers Lung Disease Prevention 
Act. The Committee adopted by voice vote an amendment in the 
nature of a substitute offered by Mrs. Woolsey which added a 
short title.
    Mr. Wilson offered an amendment in the nature of a 
substitute that would have delayed promulgation of a final 
standard until ``the National Institute of (sic) Occupational 
Safety and Health concludes there is sufficient data to support 
a recommended exposure limit.'' Mr. Wilson withdrew the 
amendment pending further discussion.
    A second amendment offered by Mr. Wilson was adopted by 
voice vote. The adopted amendment requires the National 
Institute for Occupational Safety and Health to conduct a study 
of possible substitutes for diacetyl in popcorn manufacturing, 
and to develop Recommended Exposure Limits for those found to 
be hazardous. The Committee voted to favorably report H.R. 2693 
by a voice vote.

                        III. SUMMARY OF THE BILL

    A number of individuals employed in microwave popcorn 
production and packaging and food flavoring manufacturers have 
contracted an irreversible and life threatening respiratory 
disease called bronchiolitis obliterans. There is compelling 
scientific evidence that a chemical used in artificial butter 
flavoring called diacetyl presents a grave danger and 
significant risk of bronchiolitis obliterans and other 
respiratory disease to exposed employees.
    H.R. 2693 would require OSHA to issue an interim final 
standard minimizing worker exposure to diacetyl. The standard 
must contain provisions for engineering controls, respiratory 
protection, exposure monitoring, medical surveillance and 
worker training. It must not be less protective than guidelines 
issued by the National Institute for Occupational Safety and 
Health in 2003.
    OSHA would then be required to issue a final standard 
within two years. This final standard would apply to all 
locations where there is worker exposure to diacetyl and would 
include a permissible exposure limit.

                   IV. STATEMENT AND COMMITTEE VIEWS

    The Committee on Education and Labor of the 110th Congress 
is committed to ensuring that the federal government does 
everything within its power to ensure that workplaces are safe 
and that the health and safety of American workers is 
protected, consistent with the goals of the Occupational Safety 
and Health Act of 1970.
    H.R. 2693 addresses the protection of workers from 
diacetyl, and food-flavoring chemical that has been shown to 
cause serious, irreversible obstructive lung disease, called 
bronchiolitis obliterans (or popcorn lung), in exposed 
employees working in popcorn production and packaging 
facilities, as well as food flavoring production facilities 
throughout the country.
    The Committee considers this matter an emergency. Urgent 
action is needed by OSHA to protect exposed workers. NIOSH has 
reported the onset of respiratory symptoms as only months after 
exposure to diacetyl. Government officials have been aware of 
the disease since 2000 and have linked the disease to food 
flavoring chemicals since 2002. Mere guidelines for limiting 
diacetyl exposure are not sufficient. California researchers, 
for example, have found that despite the fact that government 
and industry guidance materials were issued in 2003 and 2004, 
many of their recommendations had not been implemented in 
flavor manufacturing facilities in California, according to a 
compliance survey conducted in 2006.\1\
---------------------------------------------------------------------------
    \1\Materna B, et. al. ``Fixed Obstructive Lung Disease Among 
Workers in the Flavor-Manufacturing Industry--California, 2004-2007,'' 
Morbidity and Mortality Weekly Report, 56(16) (Apr. 27, 2007) at 389-
393.
---------------------------------------------------------------------------
    In the absence of government protections, hundreds of 
former popcorn plant workers have sued companies supplying or 
making diacetyl and more than $100 million has been awarded by 
juries or paid in settlements.
    The Food and Flavoring Manufacturing Association reported 
that at least 3,000 workers are employed in producing 
flavorings throughout the country. Thousands of others working 
in the microwave popcorn and other food industries are exposed 
in the ``downstream'' use of flavorings.
    OSHA has failed to act to protect workers even though 
effective measures to protect workers from the effect of 
exposure to diacetyl are well recognized. For example, the 
National Institute for Occupational Safety and Health issued 
guidelines to be used by employers to protect workers in 2003, 
and the Flavor and Extract Manufacturers Association (FEMA) 
issued similar detailed guidelines in 2004.
            OSHA has not proceeded aggressively to prevent worker 
                    exposure to diacetyl
    The first suspicions that bronchiolitis obliterans among a 
group of workers was linked to their work surfaced in 2000. 
NIOSH first linked bronchiolitis obliterans to food flavorings 
in 2002 and evidence quickly accumulated pointing to an 
artificial butter flavoring chemical called diacetyl.
    Despite evidence of substantial work-related hazards, OSHA 
has not taken action to minimize exposure to diacetyl. In 2002, 
it notified its Regional Administrators about the problem and 
formed a short term alliance with the Popcorn Board.\2\ Since 
then, OSHA has announced its intention to issue a Safety and 
Health Information Bulletin, but nothing has been issued as of 
this time. Hours before the Subcommittee's April 24 hearing, 
OSHA announced a National Emphasis Program (NEP) for the 
popcorn industry, where all microwave popcorn facilities that 
use diacetyl would be inspected before the end of 2007. Despite 
the announcement, the NEP has not yet been implemented, nor has 
any significant OSHA action been taken in addressing the 
problem in flavoring manufacturing.
---------------------------------------------------------------------------
    \2\Have OSHA Standards Kept up With Workplace Hazards? Hearing 
before the Subcommittee on Workforce Protections, 110th Congress, 1st 
Session (2007) (written testimony of Edwin Foulke, at 3).
---------------------------------------------------------------------------
    In July 2006, two labor unions, the United Food and 
Commercial Workers and the International Brotherhood of 
Teamsters, petitioned OSHA to immediately issue an Emergency 
Temporary Standard for diacetyl. The petition was accompanied 
by a supportive letter from 42 of the nation's leading 
occupational safety and health scientists and experts (see 
Appendix). In August of 2007, U.S. Representatives George 
Miller (D-CA), Major Owens (D-NY), and Hilda Solis (D-CA) sent 
a letter to OSHA supporting the union petition. OSHA has not 
responded to the petition.\3\
---------------------------------------------------------------------------
    \3\Letter to the Department of Labor Secretary Elaine Chao (Aug. 2, 
2006).
---------------------------------------------------------------------------
            Workers are paying the price for OSHA inaction
    Bronchiolitis obliterans is a severe, irreversible and 
often fatal lung disease that has been found to be caused by 
exposure to diacetyl. Dozens of workers at microwave popcorn 
plants and flavor manufacturing facilities have suffered severe 
occupational lung disease and several have died.
    Eric Peoples, a former microwave popcorn plant worker in 
Jasper, Missouri, contracted bronchiolitis obliterans from 
exposure to diacetyl. In his testimony before the committee, 
Peoples revealed that the company that supplied the butter 
flavor, Bush Boake Allen, a subsidiary of International Flavors 
& Fragrances (IFF) had extensive notice about the hazards of 
butter flavor and took measures to protect its own workers 
including respiratory protection and enclosure of the 
process.\4\
---------------------------------------------------------------------------
    \4\Have OSHA Standards Kept up With Workplace Hazards? Hearing 
before the Subcommittee on Workforce Protections, 110th Congress, 1st 
Session (2007) (written testimony of Eric Peoples, at 2) [Hereinafter 
Peoples Testimony].
---------------------------------------------------------------------------
    He went on to describe how BASF Chemical Company, a 
supplier of diacetyl, sent IFF a Material Safety Data Sheet 
(MSDS) in 1994 which disclosed rats that had inhaled the 
chemical diacetyl developed severe respiratory problems 
including emphysema. IFF was also aware of two employees at a 
baking company who had been diagnosed with bronchiolitis 
obliterans in 1986 while mixing a butter flavoring for use on 
cinnamon rolls.
    Peoples described how he worked with the hazardous chemical 
without information that could have protected him.
          Despite all this information the buckets containing 
        this product said the product was safe. The Material 
        Safety Data Sheets said the product had ``no known 
        health hazards'' and that's what I believed.\5\
---------------------------------------------------------------------------
    \5\Peoples Testimony at 3.
---------------------------------------------------------------------------
    Peoples paid the price for this negligence:
          Let me bring it home to you if I can. I have a 24% 
        lung capacity. I am currently on the inactive Lung 
        Transplant registry. One case of pneumonia could cause 
        me to need the transplant now. The average rate of 
        survival for someone with a lung transplant is about 
        five years. Seventy-five percent of lung transplant 
        patients are dead after 10 years.\6\
---------------------------------------------------------------------------
    \6\Id.
---------------------------------------------------------------------------
    Linda Redman worked with Eric Peoples. Her experience was 
described in a story in the St. Louis Post Dispatch:

          Linda Redman started working as a packer at the 
        Jasper popcorn plant in 1995, two years after the 
        original study. Within two years, her breathing was so 
        bad that she had to quit.
          Redman used to work 12 hours a day and then come home 
        to garden, cook dinner, and do her family's laundry. 
        Now, she lives alone in Joplin, relying on home health 
        nurses four days a week to help with basic chores 
        around the house.
          Redman, 55, doesn't have the stamina to change her 
        bedsheets or cook herself dinner, unless it's something 
        out of a can.
          Only 15 percent of her lung capacity remains. Redman 
        bides her time while waiting for a lung transplant by 
        taking breathing treatments every four hours. She is 
        constantly tethered to an oxygen tank, but she still 
        gets exhausted walking from the bedroom to the couch.
          ``There's no amount of money that can ever buy back 
        what we've lost--our health,'' Redman said of herself 
        and the other sick workers. ``There's a couple of us I 
        don't think can make it much longer.''\7\
---------------------------------------------------------------------------
    \7\Sarah Shipley, ``Study Showed Chemical was Toxic,'' St. Louis 
Post Dispatch (Feb. 28, 2004).

    Linda Redman died April 30, 2006.\8\
---------------------------------------------------------------------------
    \8\``Popcorn Lung Victim Linda Redman Dies,'' Associated Press (May 
2, 2006).
---------------------------------------------------------------------------
    The Sacramento Bee reported on Irma Ortiz and Frank Herrara 
who also suffered irreversible lung damage due to exposure to 
diacetyl.

          Hacking and gasping, Irma Ortiz could cart her 
        groceries only so far before she'd catch other shoppers 
        glaring at her.
          Mortified, she'd abandon her cart on the spot and 
        bolt for the door.
          Frank Herrera could gun his dirt bike only so far 
        before choking on the rush of air. Go. Stop. Go. Stop. 
        Exasperated, he gave up riding.
          Ortiz, 44, and Herrera, 34, are odd candidates for 
        lung transplants, being nonsmokers and having 
        considerable youth on their side.
          How they lost 70 to 80 percent of their breathing 
        capacity is no less astonishing. They acquired the same 
        rare, lung-ravaging disease from breathing the same 
        chemicals on the same type of job.
          The two weren't working in a chemical or pesticide 
        plant. Nor in a weapons plant. They didn't metal-plate, 
        fumigate, degrease, demolish, smelt or weld.
          They made, of all things, artificial food flavorings.
          * * *
          ``They never said nothing to us about the chemicals 
        there, the kinds of dangers or give us a warning like, 
        you know, `This is bad for you guys, protect yourselves 
        better,''' Ortiz said of her former employer. ``They 
        never say nothing to us like that.''\9\
---------------------------------------------------------------------------
    \9\Chris Bowman, ``Two Workers Need Transplants; Threat Could Be 
Widespread,'' Sacramento Bee (July 30, 2006).
---------------------------------------------------------------------------
            Compelling scientific evidence that diacetyl is hazardous
    There is compelling human and animal-based evidence that 
diacetyl is hazardous, presents a grave risk to exposed 
workers, and must be controlled.
    There is evidence as far back as 1985 that flavoring 
chemicals, including diacetyl, were hazardous when 
bronchiolitis obliterans was identified in flavoring 
manufacturing workers, although the cause was not identified at 
that time.\10\ In 1993, BASF, a manufacturer and supplier of 
diacetyl, conducted an inhalation study of diacetyl using rats. 
The study found that that ``mid and high concentrations 
resulted in an abundance of symptoms indicative for respiratory 
tract injury. In the mid concentration group, these symptoms 
developed mainly from day one onward * * *'' The study was 
never reported to the government or published in scientific 
literature.\11\
---------------------------------------------------------------------------
    \10\Materna B, et. al. ``Fixed Obstructive Lung Disease Among 
Workers in the Flavor-Manufacturing Industry--California, 2004-2007,'' 
Morbidity and Mortality Weekly Report, 56(16) (April 27, 2007) at 389-
393.
    \11\BASF. Report: Study on the Acute Inhalation Toxicity LC50 of 
Diacetyl FCC as a Vapor in Rats 4-hour Exposure. Project No. 1310247/
927010 (June 8, 1993).
---------------------------------------------------------------------------
    In 2002, a NIOSH investigation found ``that workers exposed 
to flavorings at microwave popcorn factories are at risk for 
developing fixed obstructive lung disease.'' Workers at one 
plant had chronic cough and shortness of breath at a rate 2.6 
times higher than what would be expected in the U.S. 
population. Twice as many workers as expected reported being 
told by their physicians that they had asthma or chronic 
bronchitis. Lung function testing revealed that three times as 
many workers as expected had obstruction to airflow.\12\
---------------------------------------------------------------------------
    \12\Kreiss K, et al. ``Clinical Bronchiolitis Obliterans in Workers 
at a Microwave-Popcorn Plant. N Engl J.Med. 347(5) (2002) at 330-338.
---------------------------------------------------------------------------
    NIOSH has conducted eight investigations at microwave 
popcorn facilities at facilities in a number of locations 
throughout the United States, finding respiratory impairment 
among workers at a majority of the plants and recommending 
actions similar to those recommended in H.R. 2693 to reduce 
exposure.\13\
---------------------------------------------------------------------------
    \13\Centers for Disease Control and Prevention. Morbidity and 
Mortality Weekly Report. Fixed Obstructive Lung Disease in a Microwave 
Popcorn Factory-Missouri, 2000-2002. 51 (Apr. 26, 2002) at 345-347. See 
also: HETA 2006-0303-3043, Carmi Flavor and Fragrance Company, Inc., 
Commerce, California (April 2007); HETA 2006-00195-3044, Yatsko's 
Popcorn, Sand Coulee, Montana (April 2007); HETA 2000-0401-2991, 
Gilster-Mary Lee Corporation, Jasper, Missouri (Jan. 2006); HETA 2001-
0474-2943, American Pop Corn Company, Sioux City, Iowa, July 2004, HETA 
2003-0112-2949, ConAgra Snack Foods, Marion, Ohio (Dec. 2004); HETA 
2002-0089, Nebraska Popcorn, Clearwater, Nebraska (July 2003); HETA-
2002-0408-2915, Agrilink Foods Popcorn Plant, Ridgeway, Illinois (Oct. 
2003); HETA 2001-0517, B.K. Heuermann Popcorn Inc., Phillips, Nebraska 
(final and interim letters) (May 2003); HETA 1985-171-1710, 
International Bakers Services, Inc., South Bend, Indiana (July 1986).
---------------------------------------------------------------------------
    In its most recent report at Carmi Flavor and Fragrance 
Company, where workers worked mostly with powdered flavorings, 
NIOSH found that ``it is highly likely that exposures to 
diacetyl contributed to the occurrence of severe fixed 
obstructive lung disease in production workers'' and 
recommended engineering controls, respiratory protection, 
improved work practices and medical monitoring.\14\
---------------------------------------------------------------------------
    \14\HETA 2006-0303-3043, Carmi Flavor and Fragrance Company, Inc., 
Commerce, California (April 2007).
---------------------------------------------------------------------------
    A NIOSH investigation of Gilster MaryLee popcorn plant 
found that workers ``had 3.3 times the rate of obstruction on 
NIOSH spirometry tests compared to national rates; the 
prevalence of obstruction in never-smokers was 10.8 times the 
national rate'' and that 19 of 21 affected workers had symptoms 
consistent with bronchiolitis obliterans.
    Furthermore, ``a strong exposure-response relationship was 
demonstrated between quartiles of estimated cumulative exposure 
to diacetyl (a volatile butter flavoring chemical contaminating 
the air in the plant) and the frequency of airways obstruction 
on spirometry tests.'' NIOSH recommended engineering controls 
(such as closed systems), air sampling, respiratory protection 
and medical monitoring.\15\
---------------------------------------------------------------------------
    \15\HETA 2000-0401-2991, Gilster-Mary Lee Corporation, Jasper, 
Missouri (Jan. 2006).
---------------------------------------------------------------------------
    Cases of bronchiolitis obliterans have also been found 
among diacetyl-exposed workers in flavorings plants. The 
California Department of Health Services has recently reported 
eight cases among diacetyl-exposed workers employed at 
factories at which the flavorings are produced.\16\
---------------------------------------------------------------------------
    \16\Harrison R, Gelb A, Harber P. Department of Health Services, 
State of California. State of California Study: ``Food Flavoring 
Workers with Bronchiolitis Obliterans Following Exposure to Diacetyl'' 
(May 15, 2006).
---------------------------------------------------------------------------
    There is compelling scientific evidence supporting a 
permissible exposure limit at the lowest feasible level, since 
there is currently no evidence of a safe level of exposure to 
diacetyl. In their evaluation of six microwave popcorn plants 
(five of which had workers with flavoring-associated lung 
disease), NIOSH scientists reported sick workers were found 
even in areas with the lowest exposure levels measurable. On 
the basis of this finding, the NIOSH scientists concluded ``it 
would seem prudent to maintain worker exposures to diacetyl 
below these levels.'' The study also concluded that very high 
(peak) exposures needed to be controlled even if average levels 
were low.\17\
---------------------------------------------------------------------------
    \17\Kanwal R, et al. ``Evaluation of Flavorings-Related Lung 
Disease Risk at Six Microwave Popcorn Plants,'' J. Occup. Enviro. Med., 
48(2) (2006) at 149-157.
---------------------------------------------------------------------------
    Some have objected to the requirements of H.R. 2693 because 
employers may substitute other chemicals that may be as 
dangerous as diacetyl. Substitution of one chemical for an 
equally or more dangerous chemical is always a risk. That 
possibility, however, could be used as a reason never to 
regulate any chemical. Federal law requires manufacturers and 
employers to evaluate the safety of chemicals to which workers 
are exposed. Due diligence and compliance with the law should 
minimize this risk with diacetyl or any other hazardous 
chemical.
    While many of the studies of food flavoring and popcorn 
production workers describe exposure to a variety of food 
flavoring chemicals, there is compelling scientific evidence 
from animal and human studies showing that diacetyl is the main 
chemical causing respiratory symptoms and bronchiolitis 
obliterans.
    The role of diacetyl in the development of bronchiolitis 
obliterans has been confirmed in studies of laboratory animals. 
In addition to the BASF study mentioned above, NIOSH scientists 
conducted a study in which rats were exposed to airborne 
concentrations of heated butter flavoring whose primary 
constituent was diacetyl. The rats were exposed for a single, 
six-hour period. The scientists reported significant lung 
damage among rats whose exposure was as low as 203 ppm, which 
according to the authors was ``not extraordinary when compared 
with levels measured in the workplace.''\18\
---------------------------------------------------------------------------
    \18\Hubbs AF, et al. ``Necrosis Of Nasal And Airway Epithelium In 
Rats Inhaling Vapors Of Artificial Butter,'' Toxicology and Applied 
Pharmacology (2002) at 185, 128-135.
---------------------------------------------------------------------------
    NIOSH scientists then conducted a study in which rats were 
exposed to pure diacetyl and found similar results.\19\
---------------------------------------------------------------------------
    \19\Hubbs AF, et al. ``Inhalation Toxicity Of The Flavoring Agent, 
Diacetyl (2,3-Butanedione), In The Upper Respiratory Tract Of Rats,'' 
Toxicologist, 78 (S-1) (2004) at 438-439.
---------------------------------------------------------------------------
    A toxicological study of guinea pigs exposed to diacetyl 
found exposure to the chemical caused adverse effects to 
respiratory tissue and structure.\20\ And a study of the 
effects of diacetyl on the respiratory tracts of mice also 
showed respiratory damage.\21\
---------------------------------------------------------------------------
    \20\Fedan JS, Dowdy JA, Fedan KB, Hubbs AF. ``Popcorn Worker's 
Lung: In Vitro Exposure To Diacetyl, An Ingredient In Microwave Popcorn 
Butter Flavoring, Increases Reactivity To Methacholine.'' Toxicol Appl 
Pharmaco, 215 (2006) at 17-22.
    \21\Morgan DL, Flake G, Kirby PJ, et. al. ``Respiratory Tract 
Toxicity Of Diacetyl In C57BL/6 Mice,'' Toxicol Sci, 90 (Suppl 1) 
(2006) at 210.
---------------------------------------------------------------------------
    A recent Dutch study of the effects of diacetyl on workers 
employed in the manufacture of diacetyl found that the exposed 
workers had a considerably higher number of cases of 
bronchiolitis obliterans than the unexposed population, as well 
as significantly more symptoms of continuous trouble with 
breathing, daily cough and asthma. The authors concluded that, 
while they could not definitively identify diacetyl as the 
cause of the disease cases, the findings were ``consistent with 
findings in the literature of bronchiolitis obliterans (BO) 
cases associated with butter flavoring exposure and in 
particular diacetyl in popcorn workers.''\22\
---------------------------------------------------------------------------
    \22\Van Rooy, G.B.G.J., et. al. ``Respiratory Effects In Workers Of 
A Diacetyl Production Plant With A Special Focus On Bronchiolitis 
Obliterans,'' Nederlands Kenniscentrum Arbeid en Longaandoeningen, 
University of Utrecht, Institute for Risk Assessment Sciences (2005).
---------------------------------------------------------------------------
    The California Department of Health Services (DHS), which 
is taking an active role in addressing workplace diacetyl 
hazards, has strong evidence concerning the threat of diacetyl. 
DHS sent a letter to employers last year warning about two 
cases of bronchiolitis obliterans among workers at food 
flavoring companies in California. ``This disease has been 
linked to exposure to diacetyl, a butter flavoring 
ingredient.\23\
---------------------------------------------------------------------------
    \23\``To Cases of Bronchiolitis Obliterans (Life-Threatening Lung 
Disease) Among California Flavoring Manufacturing Workers,'' 
Occupational Health Branch, CA Dep't of Health Services (May 15, 2006).
---------------------------------------------------------------------------
    California DHS has also issued an Alert specifically 
targeting diacetyl use. The Alert states that ``Exposure to 
diacetyl used in flavoring manufacturing companies may cause a 
serious lung disease called bronchiolitis obliterans.* * * If 
you work at a flavoring company that uses diacetyl, see a 
doctor immediately to make sure that your health is not being 
affected.'' The Alert recommends substitution for less 
hazardous flavoring ingredients, closed production processes, 
ventilation and respiratory protection.\24\
---------------------------------------------------------------------------
    \24\``Diacetyl (Butter Flavor Chemical) Use in Flavoring 
Manufacturing Companies,'' Hazard Evaluation System & Information 
Service, Occupational Health Branch, CA Dep't of Health Services (Aug. 
2006).
---------------------------------------------------------------------------
    While more study of diacetyl and other food flavoring 
chemicals can and should be done, the overwhelming weight of 
current evidence points to diacetyl as the culprit chemical 
causing respiratory disease. Evidence available today 
necessitates action and the passage of this bill. We know how 
to prevent workers from getting sick and dying. Inaction is 
unacceptable.
            Workers can be protected against diacetyl
    While more studies are needed to identify the precise 
mechanisms by which diacetyl causes lung disease, there are 
proven measures that can be implemented immediately by 
employers to effectively protect workers from dangerous 
exposure. Based on these proven measures, H.R. 2693 directs 
OSHA to mandate that these measures be taken--within three 
months in microwave popcorn and food flavoring manufacturers, 
and within two years for other locations where workers are 
exposed to diacetyl.
    The National Institute for Occupational Safety and Health 
issued guidelines in 2003 after documenting bronchiolitis 
obliterans in several different plants where flavorings were 
used or where chemicals were handled in the production of 
flavorings. NIOSH recommended that companies limit hazardous 
exposures by substituting safer chemicals, enclosing operations 
that use flavoring chemicals, use local exhaust ventilation, 
employ work practices that reduce the likelihood of inhaling 
harmful vapors, and use appropriate respiratory protection. 
NIOSH also recommended air monitoring, medical surveillance, 
worker training and labeling of containers.\25\
---------------------------------------------------------------------------
    \25\``Preventing Lung Disease in Those Who Use or Make 
Flavorings,'' National Institute for Occupational Safety and Health 
(NIOSH) Alert (2004).
---------------------------------------------------------------------------
    The industry association that represents food flavoring 
manufacturers has recognized the hazard and is recommending 
measures that employers should take to protect workers. In 
August 2004 the Flavor and Extract Manufacturers Association 
(FEMA) issued a report, ``Respiratory Health and Safety in the 
Flavor Manufacturing Workplace,'' warning about potential 
serious respiratory illness in workers exposed to flavorings 
and recommending comprehensive control measures for diacetyl 
and other ``high priority'' substances used in flavoring 
manufacturing.\26\
---------------------------------------------------------------------------
    \26\``Respiratory Health and Safety in the Flavor Manufacturing 
Workplace,'' Flavor and Extract Manufacturers Association of the United 
States (2004).

    Despite the need for more investigation, FEMA recognizes 
that sound respiratory health and safety programs can be 
implemented without absolute certainty about the contribution 
of other food flavors to the observed effects. It is clear that 
flavors can be handled in such a manner that present a minimal 
health risk. The Association recommends that employers take the 
same measures recommended by NIOSH and includes detailed 
information that employers can use to prevent worker exposure.
    A 2007 CDC publication recommends basic industrial hygiene 
precautions:

          Safe occupational exposure levels for diacetyl and 
        many other flavoring chemicals have not been 
        established. Employers should implement measures to 
        minimize exposure. Engineering controls, including 
        local exhaust ventilation and closed transfer of 
        chemicals, should be the primary control measures. Work 
        practices such as covering containers and minimizing 
        spills also will reduce exposures. Employers should 
        establish a comprehensive respiratory protection 
        program for organic vapors and particulates that 
        adheres to the OSHA Respiratory Protection Standard. 
        Consultation with an industrial hygienist or 
        occupational safety and health professional might be 
        necessary to implement appropriate engineering 
        controls, work practices, and an appropriate 
        respiratory protection program.\27\
---------------------------------------------------------------------------
    \27\Materna, Barbara, Dep't of Health Services, State of 
California, Summary of Eight Known Cases of Confirmed or Suspected 
Fixed Obstructive Lung Disease in California Food Flavor Manufacturing 
Workers (Jan. 11, 2007).

    Because we know how to protect workers against diacetyl 
exposure, particularly in the production of microwave popcorn 
and food flavorings, it would be unacceptable from a public or 
occupational health perspective to delay these protections in 
microwave popcorn or food flavorings facilities while OSHA 
receives comments on the Interim Final Standard by 
stakeholders, or reviews the standard under the Small Business 
Regulatory Enforcement Fairness Act, the Administrative 
Procedures Act or other requirements of OSHA rulemaking. Such 
procedures would still be available prior to issuance of the 
final OSHA standard.
            Workers still are not being protected from diacetyl 
                    exposure
    The urgent need for protections, as mandated under H.R. 
2693, was emphasized in a CDC Morbidity and Mortality Weekly 
Report published in April 2007 that reported that California 
food flavoring workers exposed to diacetyl and butter 
flavorings still are not being adequately protected despite 
government and industry warnings and guidelines issued in 2003 
and 2004.

          The hazards of diacetyl and butter flavoring were 
        documented in published literature in 2002. However, by 
        2006, many flavoring suppliers still had not addressed 
        the risk for bronchiolitis obliterans in their material 
        safety data sheets. During 2004, NIOSH and the Flavor 
        and Extract Manufacturers Association disseminated 
        information encouraging flavor manufacturers to 
        implement exposure controls and medical surveillance. 
        These measures were virtually nonexistent in California 
        during 2006, when industry wide government intervention 
        measures began. Before June 2006, only eight California 
        flavor-manufacturing companies had begun medical 
        screening.\28\
---------------------------------------------------------------------------
    \28\Materna B, et al. ``Fixed Obstructive Lung Disease Among 
Workers in the Flavor-Manufacturing Industry--California, 2004-2007,'' 
Morbidity and Mortality Weekly Report, 56(16) (Apr. 27, 2007) at 389-
393.

    The report also revealed that a review of material safety 
data sheets collected by the California Department of Health 
Services from 11 diacetyl manufacturers or distributors 
revealed that only ``five mention bronchiolitis obliterans and 
none listed potential symptoms or recommended medical 
surveillance for the disease.''
            California is moving ahead to regulate diacetyl
    The California Division of Occupational Safety and Health 
is moving ahead to regulate the chemical. CalOSHA established 
an advisory committee in 2007 to work on developing a diacetyl 
standard. Cal/OSHA expects to send a proposed standard to 
protect flavoring industry workers from diacetyl to the 
Standards Board in the summer of 2007. (Unlike the federal OSHA 
process, the seven-member CalOSHA Standards Board is authorized 
to issue OSHA standards.)
    Like the interim final standard mandated by H.R. 2693, the 
California standard will not address ``downstream'' use of 
diacetyl, in the food manufacturing industry. The current 
advisory committee will continue to study the issue of how to 
address issues in these workplaces.
    The draft California standard would apply to:
     Places of employment where one or more flavorings 
are manufactured, packaged or blended with other flavorings.
     Any flavoring containing diacetyl at a specified 
concentration and weight, or sprayed or added to powdered food 
product or ingredients. Workplaces with enclosed processes that 
discharge emissions outside the facility would be exempted from 
this provision.
     Facilities where an employee has been diagnosed 
with fixed obstructive lung disease and no other cause than 
occupational exposure to one of more flavorings is readily 
apparent.
    The California proposal would also require employers to 
measure employee exposure in order to determine the 
effectiveness of exposure control measures. Employers also 
would be required to implement engineering and work practice 
controls, and provide respiratory protection, medical 
surveillance and training.
            The OSHA standard-making process is not protecting workers
    The Bureau of Labor Statistics reported that in the year 
2005 there were over 5,700 workers, or 16 workers a day, killed 
in the workplace. NIOSH estimates that almost 60,000 workers 
die each year of occupational disease, many of which are caused 
by exposure to toxic chemicals.\29\
---------------------------------------------------------------------------
    \29\``Workers' Memorial Day--April 28, 2007,'' Morbidity and 
Mortality Weekly Report, 56(16) (Apr. 27, 2007) at 389-393.
---------------------------------------------------------------------------
    OSHA's standard-making process is broken, particularly 
standard-making related to hazardous chemicals. Workers exposed 
to diacetyl have fallen victim to this breakdown in the system. 
Out of the almost 3,000 chemicals produced in large quantities 
(more than one million pounds annually), OSHA enforces exposure 
limits for fewer than 500 chemicals, standards that were 
adopted when OSHA was created in 1971. Most of those are based 
on science from the 1940's and 1950's. Since the OSHAct passed 
in 1970, OSHA has issued comprehensive standards for only 27 
substances, most issued in the first two decades of OSHA 
existence.
    In recent years, it appears that the standard-making 
process had ground to a halt. Dr. Frank Mirer, a professor of 
environmental and occupational health sciences, testifying at 
the Workforce Protections subcommittee hearing on April 24, 
2007, discussed the breakdown of OSHA's standard making 
process:

          OSHA, since 2001, has checked out of the standards 
        business. Slow progress in earlier years has ground to 
        a halt and may even be moving stealthily backward. OSHA 
        has staff and other resources to set standards, but 
        that staff has not been permitted to operate. Since 
        2001, this Administration set one new chemical 
        standard, for carcinogenic chromium, under court order. 
        That standard actually permits employers to increase 
        exposure levels under some circumstances. Unions were 
        forced to sue to get improvements, and that litigation 
        still pends. Regarding employers' responsibility to pay 
        for required protective equipment like respirators and 
        wire mesh gloves, Labor Secretary Elaine Chao finally 
        committed to issuing a final rule in response to a 
        union lawsuit and a court ordered deadline. That rule 
        was promised by November 2007. The rulemaking record 
        was completed in 1999.\30\

    \30\Have OSHA Standards Kept up With Workplace Hazards? Hearing 
before the Subcommittee on Workforce Protections, 110th Congress, 1st 
Session (2007) (written testimony of Frank Mirer, at 3) [Hereinafter 
Mirer testimony].
---------------------------------------------------------------------------
    At a 2006 hearing on using non-consensus health and safety 
standards, Dr. David Michaels, Director of the Project on 
Scientific Knowledge and Public Policy and Research Professor 
and Associate Chairman Department of Environmental and 
Occupational Health at the George Washington University School 
of Public Health and Health Services, pointed out that American 
workers are left to rely on chemical standards issued by such 
organizations like the American Conference of Governmental 
Industrial Hygienists because OSHA no longer issues chemical 
standards:

          The regulatory agencies are simply unable to keep up. 
        In 1971, OSHA adopted en masse, about 400 ACGIH TLVs, 
        reached using the science of the 1950's and 1960's, 
        before we knew as nearly as much as we know today about 
        the long-term effects of many hazardous chemicals.
          Since then, OSHA has updated only a handful of them. 
        The rest have been unchanged in more than 35 years. The 
        OSHA standard setting process is cumbersome and easily 
        delayed by those intent on slowing action. The 
        political appointees who run the agency at the present 
        time have no desire to strengthen weak standards; 
        except when under a court order. Workers cannot rely on 
        OSHA to issue new regulations on chemical hazards. OSHA 
        is paralyzed and has abdicated its responsibility to 
        issue health standards that protect workers.\31\
---------------------------------------------------------------------------
    \31\Addressing Concerns about the U.S. Department of Labor's Use of 
Non-Consensus Standards in Workplace Health and Safety. Hearing before 
the Subcommittee on Workforce Protections, 109th Congress, 2nd Session 
(2006) (written testimony of David Michaels at 3) [hereinafter Michaels 
Testimony].

    Scott Schneider, Director of Occupational Safety and Health 
for the Laborers' Health and Safety Fund of North America, 
testifying at the Workforce Protections subcommittee hearing on 
April 24, 2007, pointed out three major problems with OSHA 
rulemaking: lack of budget, the burden of regulatory review, 
and lack of political will.\32\
---------------------------------------------------------------------------
    \32\Have OSHA Standards Kept up With Workplace Hazards? Hearing 
before the Subcommittee on Workforce Protections, 110th Congress, 1st 
Session (2007) (written testimony of Scott Schneider, at 2) 
[hereinafter Schneider Testimony].
---------------------------------------------------------------------------
    Dr. Frank Mirer expanded on the political obstacles:

          The first barrier to setting a new standard is 
        getting the Labor Department to recognize that 
        something needs to be done about a hazard. That's a 
        political leadership decision. Once there's a decision 
        to move forward, the task that causes the most delay is 
        gathering business data to estimate costs. But, OSHA 
        staff have figured out how to get that cost 
        information. After that, the barriers, and sources of 
        delay, are getting approval from the Office of 
        Management and Budget to put a standard on the agenda, 
        complete the small business (SBREFA) review, to release 
        a proposed standard, and to finally promulgate the 
        final standard. But, OMB is not a free agent. The same 
        President who appointed the Secretary of Labor and 
        Assistant Secretary of Labor for OSHA also appointed 
        the heads of OMB and the Small Business 
        Administration.\33\
---------------------------------------------------------------------------
    \33\Mirer Testimony at 4.
---------------------------------------------------------------------------
            OSHA standards protect workers from occupational disease 
                    and injury
    One of the most important responsibilities that Congress 
gave OSHA under the Occupational Safety and Health Act is the 
issuance of safety and health standards. Congress declared in 
passage of the Act that its ``purpose and policy'' was ``to 
assure so far as possible every working man and woman in the 
Nation safe and healthful working conditions. . . by providing 
for the development and promulgation of occupational safety and 
health standards.''
    Mirer illustrated the importance of OSHA chemical 
standards:

          Chronic illness arising from long term chemical 
        exposures at work accounts for the large majority 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.\34\
---------------------------------------------------------------------------
    \34\Mirer Testimony at 5.

    OSHA standards have proven to be effective in reducing 
exposures and protecting workers' health. According to Mirer:
          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% 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. In the accompanying 
        table, we see that OSHA's new rules have reduced 
        allowable exposure by up to 1000-fold.\35\
---------------------------------------------------------------------------
    \35\Mirer Testimony at 6

                    ANNOTATED CHRONOLOGY OF OSHA PEL'S SHOWING EXTENT OF EXPOSURE LIMITATION
----------------------------------------------------------------------------------------------------------------
            Substance                  1910       Date         Previous                Final          Reduction
----------------------------------------------------------------------------------------------------------------
Asbestos.........................         1001     1971  12 f/cc               5 f/cc                        2.4
13 Carcinogens...................         1003     1974  NA                    NA
Vinyl Chloride...................         1017     1975  500 ppm               1 ppm                         500
Asbestos.........................         1001     1976  5 f/cc                2 f/cc                        2.5
Coke Oven Emissions..............         1029     1977  0.2 mg/M\3\           0. 15 mg/M\3\                 1.3
Inorganic Arsenic................         1018     1978  0.5 mg/M\3\           0.01 mg/M\3\                   50
Lead.............................         1025     1978  200 ug/M\3\           50 ug/M\3\                      4
DBCP.............................         1044     1978  ....................  0.001 mg/M\3\                  na
Acrylonitrile....................         1045     1978  20 ppm                2 ppm                          10
Cotton Dust......................         1043     1978  1 mg/M\3\             0.2 mg/M\3\                     5
Asbestos.........................         1984   2 f/cc  0.2                   f/cc                           10
Ethylene Oxide...................         1047     1986  50 ppm                1 ppm                          50
Benzene..........................         1028     1987  10 ppm                1 ppm                          10
Formaldehyde.....................         1048     1988  3 ppm                 0.75 ppm                        4
Cadmium..........................         1027     1992  0.2 mg/M\3\           0.005 mg/M\3\                  40
Methylenedianiline...............         1050     1992  ....................  0.01 ppm                       na
Lead In Construction.............      1926.62     1993  200 ug/M\3\           50 ug/ M\3\                     4
Asbestos.........................         1001     1994  0.2 f/cc              0.1 f/cc                     \*\2
Asbestos in Construction.........    1926.1101     1994  ....................  0.1 f/cc                       na
Butadiene........................         1051     1996  1000 ppm              1 ppm                        1000
Methylene Chloride...............         1052     1998  500 ppm               25 ppm                         20
Chromium (VI)....................         1026     2006  52 g/M\3\ c           5 g/M\3\                  **10.4
----------------------------------------------------------------------------------------------------------------
*The four PEL's set for asbestos eventually mandated a 120-fold reduction from pre-OSHA PEL.
**Pre-existing PEL was a ceiling limit in units of a different chemical form; actual permitted exposure under
  the new PEL could be higher than previous.

            The need for an interim standard
    The Committee has determined that exposure to diacetyl 
presents the sort of grave danger to workers that warrants 
immediate action. A large number of studies and investigations 
show that bronchiolitis obliterans and other respiratory 
disease have been identified among a significant number of 
microwave popcorn and flavoring-manufacturing workers in a 
number of states. Extensive evidence exists that exposure to 
diacetyl presents a grave danger and significant risk of life-
threatening illness to exposed employees, and that flavoring 
and food producers are widely distributed in the United States. 
Furthermore, there are effective and feasible means to minimize 
exposure to diacetyl.
    Despite this grave danger, OSHA has failed to develop a 
comprehensive standard that would protect workers. The 
Committee also believes that guidance being developed by OSHA 
is not adequate to protect workers from the health threat posed 
by diacetyl. H.R. 2693 therefore requires OSHA to issue an 
Interim Final Standard within 90 days of enactment to be 
followed by a final standard that would be promulgated within 
two years.
    The interim standard must contain provisions for 
engineering controls, respiratory protection, exposure 
monitoring, medical surveillance and worker training. It must 
not be less protective than guidelines issued by the National 
Institute for Occupational Safety and Health in 2003.
    The interim standard requires employers to simply implement 
measures that were recommended several years ago as effective 
and feasible by NIOSH as well as the Flavor and Extract 
Manufacturers Association, the association representing 
flavoring manufacturers. In fact, FEMA supports the bill and 
the OSHA regulation. According to a statement issued by FEMA:

          ``FEMA supports legislation that could lead to 
        appropriate, science-based regulation to enhance the 
        safety of workers in the flavor industry'' said John 
        Hallagan, FEMA General Counsel. ``This legislation 
        calls for regulation by OSHA that is very similar to 
        the recommendations to protect workers that FEMA made 
        three years ago in its report Respiratory Health and 
        Safety in the Flavor Manufacturing Workplace.\36\
---------------------------------------------------------------------------
    \36\Statement by the Flavor and Extract Manufacturers Association 
(June 13, 2007).

    The interim regulation is not an occupational safety and 
health standard as that term is defined in section 3(8) of the 
Occupational Safety and Health Act of 1970 and must be adopted 
notwithstanding any other provision of law. The Secretary of 
Labor has previously recognized in promulgating a standard 
regulating hazardous waste operations the distinction between 
an interim regulation and an occupational safety and health 
standard is legally significant because it means that the 
procedural requirements of section 6 of the OSH Act do not 
apply to the promulgation of the interim final regulation. Nor, 
as the Secretary has previously recognized in publishing an 
interim final regulation governing hazardous waste operations, 
do the notice and comment provisions of the Administrative 
Procedures Act apply.
    The Committee relied upon these precedents when it directed 
the Secretary of Labor to publish an interim final regulation 
governing lead exposure in the construction industry. The 
Committee intends that the Secretary rely on similar procedures 
to publish an interim final regulation governing diacetyl 
within three months. These procedures have recently been upheld 
by OSHRC the Occupational Safety and Health Review Commission 
(OSHRC) in the Manganas Painting Co, Inc decision. OSHRC agreed 
with the Secretary of Labor's assessment of Congressional 
intent which cited

          The preamble to the lead in construction standard 
        that ``Congress . . . did not impose any procedural 
        requirements that must be followed'' and that Congress 
        intended that ``the Secretary need not follow the 
        procedural requirements of the OSH Act or the APA 
        [Administrative Procedure Act, 5 U.S.C. 553].'' 58 Fed. 
        Reg. at 26,591.\37\
---------------------------------------------------------------------------
    \37\Secretary of Labor v. Manganas Painting Company Inc, OSHRC 
Docket No. 94-0588 (March 23, 2007).

    While the Secretary is authorized to publish the interim 
regulation without the notice and comment procedures required 
by section 6 of the OSH Act, it is the Committee's expectation 
that OSHA will work closely with the National Institute for 
Occupational Safety and Health, as well as the affected 
industry, labor representatives and industrial hygiene experts 
in developing the interim final diacetyl regulation.
            The final standard
    H.R. 2693 requires OSHA, within two years of enactment, to 
issue a permanent standard regulating worker exposure to 
diacetyl in compliance with section 6(b) of the Occupational 
Safety and Health Act (OSHAct). The final standard would expand 
the scope of the regulation to all locations where workers are 
exposed to diacetyl and require OSHA to include a permissible 
exposure limit.
    While there is compelling evidence, as indicated above, on 
which to base an interim standard covering the food flavoring 
and popcorn manufacturing industries, additional data must be 
collected and analyzed before extending the standard to all 
locations where workers are exposed to diacetyl. Workers are 
also exposed to diacetyl in downstream food manufacturing 
facilities other than microwave popcorn production, although 
the level of exposure and health effects suffered by workers in 
these establishments have not been characterized to the same 
extent as in microwave popcorn production, nor have feasible 
means of abatement been fully identified by OSHA or NIOSH.
    In addition, scientists at OSHA and NIOSH have not yet 
determined an appropriate exposure limit for diacetyl that 
would prevent serious health effects.
    H.R. 2693 requires OSHA to issue a final standard covering 
all workplaces where diacetyl is used within two years of 
enactment. The Committee is confident that this standard can be 
issued within the timeframe allotted.
    It is the Committee's hope and expectation that, in 
addition to public and scientific input, OSHA will work closely 
with NIOSH to develop the information base and analysis 
necessary to develop exposure, feasibility and other 
information needed to issue a fully protective diacetyl 
standard in a timely manner.
    H.R. 2693 does not exempt OSHA from the requirements of 
section 6 of the OSHAct that Congress and the courts have 
established to ensure that OSHA standards reflect the best 
science available, or that the standards are technologically 
and economically feasible. In addition, regulatory oversight 
laws, including the Administrative Procedures Act, the Small 
Business Regulatory Enforcement Fairness Act (SBREFA), the 
Regulatory Flexibility Act, the Paperwork Reduction Act, or 
Executive Order 12866 are flexible enough to provide for 
expedited action in emergency situations like these.
    Congress has afforded OSHA a great deal of leeway in 
identifying hazards and setting protective exposure limits to 
enable the agency to act before large numbers of individuals 
were injured as a result. Section 6(b)(5) of the law lays out 
the criteria for issuance of standards concerning toxic 
materials. Section 6(b)(7) requires standards to include 
requirements for labeling, protective equipment, exposure 
monitoring and medical monitoring as appropriate.
    OSHA is mandated to attain the ``highest degree of health 
and safety protection for the employee'' and to base standards 
on the ``best available evidence.''\38\ The courts have 
recognized, however, that such data is often imperfect and that 
``OSHA cannot let workers suffer while it awaits the Godot of 
scientific certainty.''\39\ Subsequent court decisions have 
also required OSHA to show that substance presents a 
``significant risk'' and that the new standard will reduce that 
risk. OSHA must also show that the new standard is 
technologically and economically feasible.
---------------------------------------------------------------------------
    \38\29 U.S.C. 655(b)(5).
    \39\United Steelworkers of America, etc. v. Marshall, 647 F.2d 
1189, 1266 (U.S. App. D.C.); 8 OSH Cases 1810.

    Two years provides adequate time for OSHA to develop the 
evidence and findings necessary to issue a final standard. 
Extensive studies and investigations have been conducted of 
workers exposed to diacetyl and serious, readily observable 
health effects have been linked to these exposures. The courts 
have held that in cases where the risk of exposure ``can be 
readily observed,'' OSHA would be able to establish significant 
risk without the theoretical modeling involved, for example, in 
determining exposure limits for carcinogens at very low 
levels.\40\
---------------------------------------------------------------------------
    \40\Rabinowitz, Ed. Occupational Safety & Health Law 2d Ed. (BNA 
2000) at 453-454.

          OSHA can establish significant risk without the 
        theoretical modeling required to construct a dose-
        response curve when risk can be directly observed or 
        the hazard is obvious. For example, in upholding the 
        Agency's electric power generation standard, the 
        Eleventh Circuit approved OSHA's reliance on a 
        videotape showing that certain work clothes were 
        flammable, finding it ``powerful'' evidence of 
        harm.\41\ The court did not require OSHA to quantify 
        the magnitude of the fire hazard. Similarly, in 
        upholding the standard on logging operations, the 
        Fourth Circuit observed that common sense and the 
        opinion of experts were enough to establish significant 
        risk.\42\
---------------------------------------------------------------------------
    \41\Alabama Power Co. v. OSHA, 89 F.3d 740, 745 (11th Cir. 1996); 
17 OSH Cases 1675.
    \42\Homelite v. OSHA, 74 F.3d 1232 (4th Cir. 1996); 17 OSH Cases 
1489.

    In order to issue a standard under Section 6(b) of the Act, 
OSHA also has a number of procedural requirements that must be 
satisfied. Again, because of the emergency nature of this 
problem, OSHA will be able to meet those requirements within 
the two year timeframe. SBREFA\43\, the Regulatory Flexibility 
Act,\44\ Executive Order 12866 and the Paperwork Reduction Act 
contain flexible provisions for waivers, delay or acceleration 
of their requirements under emergency conditions or other 
special circumstances. The Committee expects OSHA, the Small 
Business Administration, the Office of Management and Budget, 
and other agencies involved in the regulatory process to fully 
utilize whatever actions are necessary and permitted within 
relevant laws and executive orders affecting the regulatory 
process to ensure that this mandated Congressional deadline is 
met.
---------------------------------------------------------------------------
    \43\P.L. 104-121. Small Business Regulatory Enforcement Fairness 
Act of 1996.
    \44\P.L. 96-354. Regulatory Flexibility Act of 1980, as amended.
---------------------------------------------------------------------------
    Experts confirm that OSHA can issue standards much faster 
than the agency has acted over the past several years. Frank 
Mirer expresses confidence that OSHA should be capable of 
issuing standards much faster than it currently does, even 
starting from scratch.\45\
---------------------------------------------------------------------------
    \45\Mirer Testimony at 5.
---------------------------------------------------------------------------
    Adam Finkel, Sc.D., CIH, Professor of Environmental and 
Occupational Health at the UMDNJ School of Public Health, and a 
visiting professor of public affairs at the Woodrow Wilson 
School at Princeton University, submitted testimony for the 
record following the April 24 hearing on OSHA standards, 
stating that despite the many requirements for OSHA to invite 
participation by stakeholders and respond substantively to 
their comments, standards can be completed ``cleanly and rather 
quickly.'' Finkel is the former Director of Health Standards 
for OSHA.

          In one 18-month period of activity (late 1996 to 
        early 1998)--OSHA promulgated three major final health 
        standards--those for 1,3-butadiene, methylene chloride, 
        and generic respiratory protection--and defended them 
        in Congressional oversight hearings and court 
        challenges, without a single provision being 
        substantively weakened following any of this 
        scrutiny.\46\
---------------------------------------------------------------------------
    \46\Have OSHA Standards Kept up With Workplace Hazards? Hearing 
before the Subcommittee on Workforce Protections, 110th Congress, 1st 
Session (2007), Letter from Dr. Adam Finkel to Rep. Lynn Woolsey (May 
8, 2007).
---------------------------------------------------------------------------
            History of Congressional intervention in OSHA rulemaking
    Congress has a long history of mandating OSHA regulation to 
protect workers when the Agency fails to act on its own. H.R. 
2693 continues the Congress's tradition of ensuring that OSHA 
acts promptly when faced with evidence that American workers 
face grave dangers and delay will result in needless illness 
and death. In 1986, as part of the Superfund Amendments and 
Reauthorization Act (SARA), Congress mandated the issuance an 
``interim'' standard for Hazardous Waste Operations and 
Emergency Response within 60 days and a final standard within 
one year of SARA's enactment.\47\ In 1990, as part of the Clean 
Air Act Amendments, Congress required OSHA to issue the Process 
Safety Management standard within one year. Congress also 
included directions on the content of the standard.\48\ In 
1991, Congress ordered OSHA to issue the final Bloodborne 
Pathogens Standard by a certain date, and stated that if that 
deadline was not met, the previously published proposed 
standard would take effect.\49\ In 1992, Congress mandated OSHA 
to issue the Lead in Construction standard and required the new 
standard to be ``as protective'' as the U.S. Department of 
Housing and Urban Development's worker protection guidelines 
for identification and abatement of lead based paint in certain 
housing. The standard was issued in 1993.\50\ Finally, in 2000, 
Congress required OSHA issue an update to the Bloodborne 
Pathogens standard, requiring safer syringes and sharps.\51\ 
That standard was issued in 2001.
---------------------------------------------------------------------------
    \47\P.L. 99-499. Superfund Amendments and Reauthorization Act of 
1986, Title I Sec. 126 a-f (Oct. 26, 1986).
    \48\P.L 101-549. Title III, Sec. 304 (Nov. 15, 1990).
    \49\P.L. 102-170. Departments of Labor, Health and Human Services, 
and Education, and Related Agencies Appropriations Act, Sec. 100 
(1992).
    \50\P.L. 102-550. This interim final rule was mandated by, and 
issued under the exclusive authority of, title X, subtitle C, sections 
1031 and 1032, Worker Protection, of the Housing and Community 
Development Act of 1992.
    \51\P.L. 106-430. Needlestick Safety and Prevention Act.
---------------------------------------------------------------------------
    Some OSHA experts feel that Congress must take a much more 
active role in encouraging OSHA to issue standards that protect 
workers' health and safety; Scott Schneider, who testified at 
the April 2007 standards hearing argued in favor of Congress 
setting strict time limits for OSHA to issue standards:

          Congress can set time limits for OSHA to consider and 
        then issue proposals and final rules. In the past 
        Congress has mandated that OSHA issue rules within a 
        six-month period and the agency has done so (e.g. lead, 
        hazardous waste). Congress should give OSHA a limited 
        time, say four months, to consider any petition for new 
        standards and require the agency to publish a response 
        in the Federal Register as to its reasons for accepting 
        or denying the petition. The burden should be on the 
        agency to show why a standard should not be issued. 
        Once committed to a rule making, the agency would be 
        given additional deadlines to meet to ensure that rules 
        are issued in a timely manner, say no more than three 
        years. Congress would have to provide additional 
        funding for OSHA dedicated to standard setting in order 
        for it to meet these deadlines.\52\
---------------------------------------------------------------------------
    \52\Schneider Testimony at 5.

    Due to the serious health effects caused by exposure to 
diacetyl and the ready availability of means to prevent worker 
exposure, H.R. 2693 requires OSHA to take swift action to 
protect workers.

                     V. SECTION-BY-SECTION ANALYSIS

Section 1. Short Title

    Provides that the Short Title of H.R. 2693 is the ``Popcorn 
Workers Lung Disease Prevention Act.''

Section 2. Findings

    This section declares that an emergency exists concerning 
worker exposure to diacetyl and that a standard is urgently 
needed to protect workers. This section establishes that there 
is strong evidence documenting the link between diacetyl and 
serious lung disease. The findings also establish that 
government and industry health guidelines have existed since 
2003 and 2004. Additionally, OSHA has taken no significant 
action to begin the development of a standard and has taken not 
other significant action to protect workers.

Section 3. Issuance of Standard on Diacetyl

    Section 3 (a)(1). Requires the Secretary of labor to issue 
an interim final standard regulating worker exposure to 
diacetyl within not later than 90 days after enactment.
    Section 3(a)(1)(A). Applies the interim standard to the 
flavoring manufacturers that use diacetyl.
    Section 3(a)(1)(B). Applies the interim standard to all 
microwave popcorn production and packaging establishments that 
use diacetyl.
    Section 3(a)(2). Requires that the interim standard provide 
no less protection than NIOSH guidelines issued in 2003.
    Section 3(a)(2)(A). States that the interim final standard 
must require engineering, work practice controls, and 
respiratory protection
    Section 3(a)(2)(B). States that the interim final standard 
must require employers to develop a written exposure control 
plan that will indicate specific measures the employer will 
take to minimize employee exposure. The plan must be re-
evaluated at least biannually or whenever medical surveillance 
indicates abnormal pulmonary function in employees exposed to 
diacetyl,
    Section 3(a)(2)(C). States that the interim final standard 
must require airborne exposure assessments
    Section 3(a)(2)(D). States that the interim final standard 
must require medical surveillance for workers and referral for 
prompt medical evaluation
    Section 3(a)(2)(E). States that the interim final standard 
must require protective equipment and clothing
    Section 3(a)(2)(F). States that the interim final standard 
must require employers to provide written safety and health 
information and training to employees.
    Section 3(a)(3). Requires interim final standard to take 
effect upon issuance, have the legal effect of an OSHA 
standard, and remain in effect until a final standard becomes 
effective.
    Section 3(b). Mandates OSHA to issue a final standard 
regulating worker exposure to diacetyl not later than two years 
from the date of enactment. The final standard must contain the 
worker protection provisions of the interim final standard as 
well as a permissible exposure limit that does not exceed the 
lowest feasible level.

Section 4. Study and Recommended Exposure Limits on Other Flavorings

    This section requires the National Institute for 
Occupational Safety and Health to conduct a study on the 
exposure hazards of possible substitutes that are closely 
related to diacetyl in microwave popcorn production and 
transmit the report to OSHA. NIOSH is then required to 
establish recommended exposure limits for those flavoring 
chemicals found to be hazardous.

                     VI. EXPLANATION OF AMENDMENTS

    Because regulation of any chemical often encourages users 
to substitute for other chemicals, the amendment offered by Mr. 
Wilson and adopted by the Committee requires the National 
Institute for Occupational Safety and Health (NIOSH) to conduct 
a study on the exposure hazards of food flavoring chemicals 
closely related to diacetyl that could be used as substitutes 
for diacetyl in microwave popcorn production and transmit the 
report to OSHA. NIOSH is then required to establish recommended 
exposure limits (RELs) for those flavoring chemicals found to 
be hazardous. The RELs developed by NIOSH are to be forwarded 
to OSHA.
    NIOSH was established under the Occupational Safety and 
Health Act of 1970 to, among other things, develop and 
establish recommended occupational safety and health standards 
and to conduct research necessary for the development of 
criteria for new and improved occupational safety and health 
standards.

           VII. APPLICATION OF LAW TO THE LEGISLATIVE BRANCH

    Section 102(b)(3) of Public Law 104-1, the Congressional 
Accountability Act, requires a description of the application 
of this bill to the legislative branch. H.R. 2693 has no direct 
application to the legislation branch.

                   VIII. REGULATORY IMPACT STATEMENT

    The Committee has determined that H.R. 2693 will have only 
a minor impact on the regulatory burden.

                     IX. UNFUNDED MANDATE STATEMENT

    Section 423 of the Congressional Budget and Impoundment 
Control Act (as amended by Section 101(a)(2) of the Unfunded 
Mandates Reform Act, P.L. 104-4) requires a statement of 
whether the provisions of the reported bill include unfunded 
mandates.
    (The attached CBO letter addresses this issue)

                          X. EARMARK STATEMENT

    H.R. 2693 does not contain any congressional earmarks, 
limited tax benefits, or limited tariff benefits as defined in 
clause 9(d), 9(e) or 9(f) of rule XXI.

    XI. STATEMENT OF OVERSIGHT FINDINGS AND RECOMMENDATIONS OF THE 
                               COMMITTEE

    In compliance with clause 3(c)(1) of rule XIII and clause 
2(b)(1) of rule X of the rules of the House of Representatives, 
the Committee's oversight findings and recommendations are 
reflected in the body of this report.

            XII. NEW BUDGET AUTHORITY AND CBO COST ESTIMATE

    With respect to the requirements of clause 3(c)(2) of rule 
XIII of the House of Representatives and section 308(a) of the 
Congressional Budget Act of 1974 and with respect to 
requirements of 3(c)(3) of rule XIII of the House of 
Representatives and section 402 of the Congressional Budget Act 
of 1974, the Committee has received the following estimate for 
H.R. 2693 from the Director of the Congressional Budget Office:

H.R. 2693--A bill to direct the Occupational Safety and Health 
        Administration to issue a standard regulating worker exposure 
        to diacetyl

    H.R. 2693 would require the Department of Labor to issue 
regulations intended to protect workers from harmful exposure 
to the chemical diacetyl. Interim standards would be issued no 
later than 90 days after this bill is enacted, and a final 
standard no later than two years after enactment. Diacetyl is a 
substance used in many food flavorings, such as artificial 
butter flavorings for microwave popcorn. Since 2000, several 
organizations, including the National Institute of Occupational 
Safety and Health (NIOSH), have raised concerns regarding the 
health affects of diacetyl on workers in manufacturing plants 
that use the chemical. The Occupational Safety and Health 
Administration (OSHA) is developing an inspection program but 
no regulations have been issued to date.
    In addition, the bill would require NIOSH to conduct a 
study of food flavorings used in the production of microwave 
popcorn. The study would prioritize which chemicals are most 
closely associated with diacetyl in order to determine possible 
exposure hazards. Furthermore, NIOSH would establish 
recommended exposure limits based on the study's findings and 
transmit those findings to OSHA.
    Estimated cost to the federal government: CBO estimates 
that implementing H.R. 2693 would cost approximately $1 million 
in 2008, assuming appropriation of the necessary amounts. CBO 
assumes these funds would be used primarily to fund the NIOSH 
study required by the bill. Costs in 2009 would not be 
significant. Enacting the bill would not affect revenues or 
direct spending.
    Impact on state, local, and tribal governments: H.R. 2693 
contains no intergovernmental mandates as defined in the 
Unfunded Mandates Reform Act (UMRA). States may develop and 
operate their own job safety and health programs if those 
programs are approved by OSHA; currently, 26 states operate 
such programs. Those states might incur costs to administer and 
enforce the new standards that OSHA would be required to 
promulgate under the bill. However, those costs would be 
incurred voluntarily, and half of those costs could be 
reimbursed through matching grants from the federal government 
under an existing program.
    The state of California is in the process of developing 
standards regulating workers' exposure to diacetyl. Under H.R. 
2693, California would be required to demonstrate to OSHA that 
the state's standards will be at least as effective as the 
standards promulgated by OSHA. If its standards were determined 
to be less effective, the federal standards would apply. Any 
costs incurred by California to demonstrate the effectiveness 
of the state standards would be incurred as a result of its 
voluntary participation in the federal program.
    Impact on the private sector: H.R. 2693 would impose 
private-sector mandates as defined in UMRA on facilities that 
use, handle, or produce diacetyl--primarily involving food 
flavorings and microwave popcorn. The interim standards 
promulgated by OSHA would have to be consistent with the 
recommendations in the NIOSH Alert, ``Preventing Lung Disease 
in Workers Who Use or Make Flavorings.'' Because a large 
segment ofthose two industries has implemented many of NIOSH's 
recommended protections for diacetyl exposure, CBO estimates 
that the costs associated with compliance with the interim 
standard would fall below the annual threshold for private-
sector mandates established by UMRA ($131 million in 2007, 
adjusted annually for inflation). The interim standard would 
remain in effect until the final standard is issued.
    The final standard would contain, at a minimum, the 
provisions in the interim standards, as well as limits on 
short-term exposure and permissible exposure. The final 
standard would apply to all facilities where diacetyl is 
produced or used. The cost to the private sector of complying 
with mandates in the final standard is uncertain because it 
would depend on regulations that have not yet been established. 
Because there is no basis for predicting the specific equipment 
and procedures the final standard would require and the 
industries that would be affected, CBO cannot estimate the 
incremental costs that could result from that standard. 
Therefore, CBO cannot determine whether the aggregate cost of 
the mandates would exceed the UMRA's annual threshold for 
private-sector mandates.
    Previous CBO estimate: This estimate supersedes the 
previous cost estimate for H.R. 2693, which CBO transmitted on 
July 13, 2007. Our July 13 estimate erroneously indicated that 
the bill would require the NIOSH study to be completed prior to 
issuance of final standards from OSHA and that OSHA had already 
implemented a diacetyl inspection program. This revised 
estimate corrects the description of those provisions but does 
not change the estimated cost of the bill.
    The CBO staff contacts for this estimate are Sean Dunbar or 
Geoffrey Gerhardt (for federal costs), Lisa Ramirez-Branum (for 
the impact on state and local governments), and Justin Hall 
(for the impact on the private sector). This estimate was 
approved by Robert A. Sunshine, Assistant Director for Budget 
Analysis.

      XIII. STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES

    In accordance with Clause 3(c) of House rule XIII, the goal 
of H.R. 2693 is to provide basic health and safety protections 
for workers exposed to diacetyl.

                 XV. CONSTITUTIONAL AUTHORITY STATEMENT

    Under clause 3(d)(1) of rule XIII of the Rules of the House 
of Representatives, the Committee must include a statement 
citing the specific powers granted to Congress in the 
Constitution to enact the law proposed by H.R. 2693. The 
Committee believes that the amendments made by this bill, which 
direct OSHA to issue an OSHA standard regulating worker 
exposure to diacetyl are within Congress' authority under 
Article I, Section 8, Clause 3 of the Constitution of the 
United States.

                         XV. COMMITTEE ESTIMATE

    Clause 3(d)(2) of rule XIII of the Rules of the House of 
Representatives requires an estimate and a comparison of the 
costs that would be incurred in carrying out H.R. 2693. 
However, clause 3(d)(3)(B) of that rule provides that this 
requirement does not apply when the Committee has included in 
its report a timely submitted cost estimate of the bill 
prepared by the Director of the Congressional Budget Office 
under section 402 of the Congressional Budget Act.

                     XVI. COMMITTEE CORRESPONDENCE

    None.
                                                     July 26, 2006.
The Hon. Elaine L. Chao,
Secretary of Labor, U.S. Department of Labor,
Washington, DC.
    Dear Secretary Chao: We are writing to express our strong 
support for the petition submitted by the United Food and 
Commercial Workers International Union and the International 
Brotherhood of Teamsters calling upon the Occupational Safety 
and Health Administration to issue an Emergency Temporary 
Standard (ETS) to protect workers exposed to the chemical 
diacetyl (2,3-butanedione, CAS # 431-03-8), and to initiate 
formal rulemaking for permanent regulations to protect workers 
exposed to diacetyl and other harmful flavoring-related 
chemicals.
    Diacetyl is a commonly used food flavoring and is the 
primary constituent of artificial butter flavoring. There is 
compelling scientific evidence linking occupational exposure to 
diacetyl to bronchiolitis obliterans, a debilitating and 
sometimes fatal lung disease.
    In the general population, bronchiolitis obliterans is 
rare. In the last few years, however, numerous cases have been 
reported to or identified by the National Institute for 
Occupational Safety and Health (NIOSH) among workers employed 
in factories where flavorings containing diacetyl are produced 
or used.\1\ Dozens of workers employed at popcorn plants have 
developed occupational lung disease, and at least one has died. 
Several of these workers are on lung transplant 
lists.2 3 4
    The sentinel case of the recent outbreak of bronchiolitis 
obliterans was a Missouri microwave popcorn plant worker 
diagnosed with the condition in 1999. The physician who 
diagnosed the case notified Missouri's health department, which 
in turn notified the Centers for Disease Control and Prevention 
(CDC), NIOSH's parent agency. In August 2000, NIOSH began an 
investigation at the Jasper, Missouri microwave popcorn plant 
where eight current or former workers had developed the 
disease.\5\ In this investigation, NIOSH scientists found that 
respiratory symptoms were linked with exposure to diacetyl and 
butter flavor. Workers at this plant had chronic cough and 
shortness of breath at a rate 2.6 times higher than what would 
be expected in the U.S. population. Twice as many workers than 
expected reported being told by their physicians that they had 
asthma or chronic bronchitis. Lung function testing revealed 
that three times as many workers as expected had obstruction to 
airflow. These results were reported first in the CDC's 
Morbidity and Mortality Weekly Report and then in the 
NewEngland Journal of Medicine.\6\\7\ In all, NIOSH has 
conducted six investigations at 102 microwave popcorn 
facilities, finding respiratory impairment among workers at a 
majority of the plants.\3\\8\\9\\10\\11\\12\
    Since the initial reports focused on individuals employed 
in microwave popcorn factories, the disease is often called 
``popcorn workers lung.''\13\\14\ It has become clear, however, 
that the disease has struck workers in other segments of the 
food and flavoring industry, and is not limited to microwave 
popcorn facilities.\15\ The California Department of Health 
Services has recently reported two cases among diacetyl-exposed 
workers employed at factories at which the flavorings are 
produced.\16\
    To pursue their investigations, NIOSH has developed 
sampling and analytical methods for measuring exposure to 
flavoring-related chemicals.\17\ At the Jasper, Missouri plant, 
diacetyl was measured in concentrations ranging as high as 98 
parts per million parts air by volume (ppm), with a mean of 8.1 
ppm.\18\ In their evaluation of six microwave popcorn plants 
(five of which had workers with flavoring-associated lung 
disease), NIOSH scientists reported that the ``lowest mean TWA 
[time weighted average] diacetyl air concentrations that we 
measured in mixing areas (0.02 ppm personal exposure and 0.2 
ppm area air concentration) were at a plant with an affected 
mixer.'' On the basis of this finding, the NIOSH scientists 
concluded ``it would seem prudent to maintain worker exposures 
to diacetyl below these levels.''\19\
    The role of diacetyl in the development of bronchiolitis 
obliterans has been confirmed in studies of laboratory animals. 
In 1993, a manufacturer of diacetyl conducted a study, which 
was never reported to the government or published in scientific 
literature, in which rats were exposed to pure diacetyl. The 
study found that one four-hour period of exposure to diacetyl 
resulted in an ``abundance of symptoms indicative for 
respiratory tract injury.''\20\ Following the recent outbreak 
of cases among humans, NIOSH scientists conducted a study in 
which rats were exposed to airborne concentrations of heated 
butter flavoring, of which diacetyl was the primary 
constituent. The rats were exposed for a single, six-hour 
period. The scientists reported significant lung damage among 
rats whose exposure was as low as 203 ppm, which according to 
the authors was ``not extraordinary when compared with levels 
measured in the workplace.''\21\ NIOSH scientists then 
conducted a study in which rats were exposed to pure diacetyl 
and found similar results.\22\ A toxicological study of guinea 
pigs exposed to diacetyl found exposure to the chemical caused 
adverse effects to respiratory tissue and structure.\23\
    Although the precise number of workers already suffering 
respiratory effects from exposure to diacetyl is unknown, the 
potential magnitude of the problem is sizeable. NIOSH is 
currently investigating 15 cases of respiratory disease, 
including some workers with bronchiolitis obliterans, among the 
employees at a single Cincinnati, Ohio flavor manufacturing 
plant.\3\
    Additional research will provide useful data on the 
mechanism through which flavoring related chemicals cause 
obstructive lung disease. However, NIOSH has already generated 
sufficient information for OSHA to issue rules to reduce 
exposure to these toxic chemicals. In their recent report, 
NIOSH scientists wrote that ``(b)ecause entirely safe levels of 
occupational exposure to butter-flavoring chemicals are not 
known, it is important to limit 3 worker exposures as much as 
possible.''\19\ It is the regulatory responsibility of OSHA to 
protect workers from exposure to workplace hazards. OSHA has 
issued permissible exposure limits (PELs) and/or NIOSH has 
recommended exposure limits (RELs) for only 46 of the 1,037 
flavoring ingredients considered by the flavorings industry to 
represent potential respiratory hazards.\1\ This regulatory 
gap\2\ needs to be addressed; for this reason, we support the 
United Food and Commercial Workers (UFCW) and the International 
Brotherhood of Teamsters (IBT) petition to OSHA to initiate 
formal rulemaking to establish a permanent standard to protect 
workers from lung disease caused by flavoring-related 
chemicals.
    Until OSHA completes permanent rulemaking on flavoring-
related chemicals, an ETS for diacetyl is essential. The data 
gathered by NIOSH indicate an appropriate emergency PEL would 
be below 0.2 ppm.\19\ In order to provide a sufficient margin 
of safety, the petition calls for an emergency temporary PEL of 
0.05 ppm, averaged over an eight-hour day. Although other 
flavoring-related chemicals are likely to contribute to the 
adverse lung effects as well, controlling exposure to diacetyl, 
a known cause of bronchiolitis obliterans and a primary 
component of butter flavor, will also result in the reduction 
of exposure to other airborne contaminants in the workplace.
    In summary, there is compelling epidemiologic and 
toxicological evidence linking exposure to diacety to severe 
respiratory impairment and disease. It is more than thirty 
months since NIOSH issued an alert calling upon employers to 
``minimize occupational exposures to flavorings or flavoring 
ingredients.''\1\ It is now time for OSHA to use the scientific 
evidence to protect American workers from debilitating lung 
disease.
    If you have any questions regarding this matter, please 
contact: David Michaels, PhD, Professor and Associate Chairman, 
Department of Environmental and Occupational Health, George 
Washington University School of Public Health, 2100 M Street 
NW, Suite 203, Washington, DC 20037, Phone: 202-994-2461.
            Respectfully submitted,

(Affiliations listed for identification purpose only)

    Nicholas A. Ashford, PhD, JD, Professor of Technology and 
Policy, and Director, MIT Technology and Law Program, 
Massachusetts Institute of Technology.
    Dean Baker, MD, MPH, Professor and Chief, Occupational and 
Environmental Medicine and Director, Center for Occupational 
and Environmental Health, University of California, Irvine.
    John M. Balbus, MD, MPH, Director, Health Program, 
Environmental Defense.
    John R. Balmes, MD, Professor of Medicine, University of 
California San Francisco, and Professor of Environmental Health 
Sciences, University of California Berkeley School of Public 
Health.
    Eula Bingham, PhD, Professor, Department of Environmental 
Health, University of Cincinnati College of Medicine, and 
Assistant Secretary of Labor for Occupational Safety and 
Health, 1977-1981.
    David C. Christiani, MD, MPH, MS, Professor of Occupational 
Medicine and Epidemiology, Harvard School of Public Health, and 
Professor of Medicine, Harvard Medical School.
    Richard Clapp, DSc, MPH, Professor, Department of 
Environmental Health, Boston University School of Public 
Health.
    Mark R. Cullen, MD, Professor of Medicine and Public 
Health, Yale University School of Medicine.
    Ellen A. Eisen, ScD, Adjunct Professor of Environmental 
Health, Harvard School of Public Health.
    Adam M. Finkel, ScD, CIH, Professor of Environmental and 
Occupational Health, UMDNJ School of Public Health, and 
Director, Directorate of Health Standards Programs, OSHA, 1995-
99, and Regional Administrator, Region VIII, OSHA, 2000-2003.
    Arthur L. Frank MD, PhD, Professor of Public Health and 
Chair, Department of Environmental and Occupational Medicine, 
Drexel University School of Public Health.
    Laurence Fuortes, MD, Professor of Occupational and 
Environmental Health, College of Public Health, University of 
Iowa.
    Michael Gochfeld, MD, PhD, Professor and Director, 
Occupational & Environmental Residency Program, Environmental 
and Occupational Health Sciences Institute, UMDNJ-Robert Wood 
Johnson Medical School.
    Lynn R. Goldman, MD, MPH, Professor, Bloomberg School of 
Public Health, Johns Hopkins University, and Assistant 
Administrator for Toxic Substances, Environmental Protection 
Agency, 1993-1998.
    Philip Harber, MD MPH, Professor and Chief, Division of 
Occupational and Environmental Medicine, David Geffen School of 
Medicine at UCLA.
    Peter F. Infante, DDS, DrPH, Professorial Lecturer, 
Department of Environmental and Occupational Health, George 
Washington University School of Public Health, and Director, 
Office of Standards Review, OSHA, 1982-2002.
    Leslie M. Israel, DO, MPH, Associate Clinical Professor, 
Center for Occupational and Environmental Health, University of 
California Irvine.
    Joel Kaufman, MD, MPH, Professor, Departments of 
Environmental & Occupational Health Sciences and Medicine, and 
Director of the Occupational and Environmental Medicine 
Program, University of Washington.
    Matthew Keifer, MD, MPH, Associate Professor of Medicine 
and Environmental and Occupational Health, University of 
Washington.
    Joel N. Kline, MD, Professor and Director University of 
Iowa Asthma Center, Division of Pulmonary, Critical Care, and 
Occupational Medicine.
    Roy J. and Lucille A. Carver College of Medicine, 
University of Iowa.
    David Kriebel, ScD, Professor, Department of Work 
Environment, University of Massachusetts Lowell.
    Sheldon Krimsky, PhD, Professor of Urban & Environmental 
Policy & Planning, School of Arts and Sciences, Tufts 
University, and Adjunct Professor, Department of Public Health 
and Family Medicine, Tufts School of Medicine.
    Stephen M. Levin, MD, Medical Director, IJ Selikoff Center 
for Occupational and Environmental Medicine, Mount Sinai School 
of Medicine.
    Steven Markowitz, MD, Professor and Director, Center for 
the Biology of Natural Systems, Queens College, The City 
University of New York.
    Robert McConnell, MD, Professor of Preventive Medicine, 
Keck School of Medicine, University of Southern California.
    David Michaels, PhD, MPH, Professor and Associate Chairman, 
Department of Environmental and Occupational Health, George 
Washington University School of Public Health, and Director, 
Project on Scientific Knowledge and Public Policy (SKAPP), 
Assistant Secretary of Energy for Environment, Safety and 
Health, 1998-2001.
    Rafael Moure-Eraso, PhD, CIH, Professor and Chair, 
Department of Work Environment, University of Massachusetts 
Lowell.
    Karen B. Mulloy, DO, MSCH, Co-Director Program in 
Occupational & Environmental Health, University of New Mexico 
Health Sciences Center.
    L. Christine Oliver, MD, MPH, MS, Assistant Clinical 
Professor of Medicine, Harvard Medical School, and Associate 
Physician, Massachusetts General Hospital.
    David Ozonoff, MD, MPH, Professor and Chair Emeritus, 
Department of Environmental Health, Boston University School of 
Public Health.
    Allen J. Parmet, MD, MPH, FACPM, Colonel, United States Air 
Force (Retired).
    Anthony Robbins, MD, MPA, Professor, Tufts University 
School of Medicine, and Assistant Surgeon General and Director, 
National Institute for Occupational Safety and Health, 1971-
1981.
    Kenneth Rosenman, MD, Professor of Medicine and Chief, 
Division of Occupational and Environmental Medicine, Department 
of Medicine, College of Human Medicine, Michigan State 
University.
    Marc Schenker, MD, MPH, Professor and Chair, Department of 
Public Health Sciences, University of California at Davis 
School of Medicine.
    Brian S. Schwartz, MD, MS, Professor of Environmental 
Health Sciences, Epidemiology, and Medicine, Bloomberg School 
of Public Health, Johns Hopkins University.
    Joel Schwartz, PhD, Professor, Environmental Epidemiology, 
Exposure, Epidemiology, and Risk Program, Harvard School of 
Public Health.
    Michael A. Silverstein, MD, MPH, Clinical Professor, 
University of Washington School of Public Health and Community 
Medicine, and Director of Policy, OSHA, 1993-1995.
    Rosemary K. Sokas, MD, MOH, Director and Professor, 
Environmental & Occupational Health Sciences, University of 
Illinois at Chicago.
    Leslie Stayner, PhD, Professor and Director, Division of 
Epidemiology and Biostatistics, University of Illinois at 
Chicago School of Public Health.
    Laura S. Welch, MD, Center to Protect Workers' Rights, and 
Professorial Lecturer, Department of Environmental and 
Occupational Health, George Washington University School of 
Public Health.

                               REFERENCES

    1National Institute for Occupational Safety and 
Health. Preventing lung disease in workers who use or make 
flavorings. NIOSH Publication No. 2004-110, 2004. Available at:
http://www.cdc.gov/niosh/docs/2004-110/.
    2Michaels D, Monforton C. Scientific evidence in 
the regulatory system: Manufacturing uncertainty and the demise 
of the formal regulatory system. J Law Policy 2005;13(1): 17-
41. Available at: http://www.defendingscience.org/upload/
Scientific-Evidence-in-the-Regulatory-System-Manufacturing-
Uncertainty-and-the-Demise-of-the-Formal-Regulatory-System.pdf.
    3Schneider A. Disease is swift, response is 
slow. Baltimore Sun. April 23, 2006. Available at: http://
www.baltimoresun.com/news/health/bal-
te.flavoring23apr23,0,2684871.story?coll=balnationworld-
utility.
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Bronchiolitis obliterans syndrome in popcorn plant workers. Eur 
Resp J 2004;24: 298-302.
    5NIOSH Health Hazard Evaluation Report. HETA-
2000-0401-2991: Gilster-Mary Lee Corporation,, Jasper, 
Missouri. (January 2006). Available at: 
http://www.cdc.gov/niosh/hhe/reports/pdfs/2000-0401-2991.pdf.
    6Centers for Disease Control and Prevention. 
Morbidity and Mortality Weekly Report. Fixed obstructive lung 
disease in a microwave popcorn factory-Missouri, 2000-2002. 
51:345-347 (Apr. 26,, 2002). Available at: http://www.cdc.gov/
mmwr/preview/mmwrhtml/mm5116a2.htm.
    7Kreiss K, et al. Clinical bronchiolitis 
obliterans in workers at a microwave-popcorn plant. N Engl J. 
Med. 2002-347(5):330-338.
    8NIOSH Health Hazard Evaluation Report. HETA 
2003-0112-2949: ConAgra Snack Foods, Marion.
    Ohio. (December 2004) Available at: http://www.cdc.gov/
niosh/hhe/reports/pdfs/2003-0112-2949.pdf.
    9NIOSH. Letter to Frank Morrison, Nebraska 
Popcorn, regarding HETA 2002-0089: Nebraska, Popcorn, 
Clearwater, Nebraska. (July 2, 2003). Available at: http://
www.cdc.gov/niosh/hhe/reports/pdfs/2002-0089-letter.pdf.
    10NIOSH. Letter to Keith Heuermann, B.K. 
Heuermann Popcorn, regarding HETA 2001-0517, B.K. Heuermann 
Popcorn Inc., Phillips, Nebraska. (May 13, 2003) Available at: 
http://www.cdc.gov/niosh/hhe/reports/pdfs/2001-0517-letter.pdf.
    11NIOSH Heath Hazard Evaluation Report. HETA 
2001-0474-2943: American Pop Corn Company, Sioux City, Iowa. 
(July 2004). Available at: http://www.cdc.gov/niosh/hhe/
reports/pdfs/2001-0474-2943.pdf.
    12NIOSH Health Hazard Evaluation Report. HETA-
2002-0408-2915: Agrilink Foods Popcorn Plant, Ridgeway, 
Illinois. (October 2003). Available at: http://www.cdc.gov/
niosh/hhe/reports/pdfs/2002-0408-2915.pdf.
    13Schachter EN. Popcorn workers lung. N Engl J 
Med. 2002;347(5):360-361.
    14Parmet AJ, Von Essen S. Rapidly progressive, 
fixed airway obstructive disease in popcorn workers: a new 
occupational pulmonary illness? J Occup Environ Med. 
2002;44:216-218.
    15Lockey J.E. et al. Bronchiolitis obliterans in 
the food flavoring manufacturing industry. Abstract presented 
at the Annual Meeting of The American Thoracic Society, 20 May 
2002. Available at: http://www.abstracts2view.com/atsall/
    16Harrison R, Gelb A, Harber P. Department of 
Health Services, State of California. Food flavoring workers 
with bronchiolitis obliterans following exposure to diacetyl, 
California, May 15, 2006. Available at: http://www.capanet.org/
pdfs/BO_cases_%20final_5_16_06.pdf.
    17Pendergrass SM. Method development for the 
determination of diacetyl and acetoin at a microwave popcorn 
plant. Environ Sci Technol. 2004;38(3):858-861.
    18Kullman G, et al. Characterization of 
respiratory exposures at a microwave popcorn plant with cases 
of bronchiolitis obliterans. J Occup Environ Hyg. 2005;2:169-
178.
    19Kanwal R, et al. Evaluation of flavorings-
related lung disease risk at six microwave popcorn plants. J 
Occup Environ Med. 2006;48(2):149-157.
    20BASF. Report: study on the acute inhalation 
toxicity LC50 of diacetyl FCC as a vapor in rats 4-hour 
exposure. Project No. 1310247/927010, June 8, 1993. Available 
at: http://www.defendingscience.org/
    21Hubbs AF, et al. Necrosis of nasal and airway 
epithelium in rats inhaling vapors of artificial butter 
flavoring. Toxicol Appl Pharmacol. 2002;185:128-135.
    22Hubbs AF, et al. Inhalation toxicity of the 
flavoring agent, diacetyl (2,3-butanedione), in the upper 
respiratory tract of rats. Toxicologist. 2004 ;78(S-1):438-439. 
Available at: http://www.toxicology.org/AI/Pub/tox/2004Tox.pdf.
    23Fedan JS, Dowdy JA, Fedan KB, Hubbs AF. 
Popcorn worker's lung: In vitro exposure to diacetyl, an 
ingredient in microwave popcorn butter flavoring, increases 
reactivity to methacholine. Toxicol, Appl Pharmacol (in press). 
Abstract: Proc Am Thorac Soc 2005 May; 2(Abstracts):A814.

                             MINORITY VIEWS

                              INTRODUCTION

    Committee Republicans are united in their support for a 
safe and healthy workplace for every American worker. In 2005, 
the most recent year for which data is available, the American 
workforce saw all-time lows in occupational injury, illness, 
and fatality rates. The overall workplace injury/illness rate, 
4.6 per 100 employees in 2005, was the lowest since the Bureau 
of Labor Statistics began publishing data in 1973.\1\ In the 
last five years alone, the nationwide injury/illness rate has 
fallen by more than 13 percent, while the overall fatality rate 
has fallen by 7 percent since 2001.\2\ These numbers underscore 
and highlight Committee Republicans' commitment to and success 
in protecting the safety and health of the nation's workforce.
---------------------------------------------------------------------------
    \1\See Testimony of the Honorable Edwin G. Foulke, Jr., Committee 
on Education and Labor Subcommittee on Workforce Protections Hearing, 
``Have OSHA Standards Kept up with Workplace Hazards?'' (April 24, 
2007) (hereinafter ``Foulke Testimony''), at 2.
    \2\See id.
---------------------------------------------------------------------------
    Committee Republicans are equally committed to ensuring 
that the regulation of health and safety in the workplace is 
always based on science, hard data, and the best available 
evidence, and not on political expediency or the agenda of any 
single interest, party, or stakeholder, however well-
intentioned. As detailed herein, it is our view that H.R. 2693, 
which would mandate the Secretary of Labor to establish 
significant new workplace health and safety standards in the 
absence of sufficient scientific evidence and reliable data, 
wholly fails to meet that standard. For this reason, we oppose 
enactment of the bill.

        BACKGROUND: THE OSH ACT AND WORKPLACE SAFETY REGULATION

    Since its enactment in 1970, the Occupational Safety and 
Health Act (``OSH Act'' or the ``Act'')\3\ has fostered safe 
and healthy working environments through standards-setting, 
employer and worker education and training, and hazard 
elimination.
---------------------------------------------------------------------------
    \3\29 U.S.C. Sec. 651 et seq.
---------------------------------------------------------------------------
    Section 5 of the OSH Act requires that a covered employer 
must provide its employees with a workplace ``free from 
recognized hazards that are causing or are likely to cause 
death or serious physical harm.''\4\ In furtherance of that 
goal, section 6 of the Act sets forth the procedures which the 
Secretary of Labor is required to follow when promulgating 
workplace health and safety standards and provides for judicial 
review of these standards to any person adversely affected by 
them.\5\ These requirements guarantee that in promulgating 
regulations, the Occupational Safety and Health Administration 
(OSHA) must determine whether there is a significant risk and, 
if so, fashion a feasible compliance scheme that provides both 
for technical feasibility and economic feasibility from the 
standpoint of the regulated community.
---------------------------------------------------------------------------
    \4\29 U.S.C. Sec. 654(a).
    \5\See generally id. Sec. 655.
---------------------------------------------------------------------------
    Throughout its history, the Act's standard-setting 
processes have been governed foremost by the Administrative 
Procedures Act (APA), which generally requires a federal agency 
to develop and draft proposed regulations; issue proposed rules 
and regulations via a transparent process which allows for 
comment and input from affected stakeholders; and review and 
incorporate as appropriate that input in the publication of its 
final rule.\6\ In addition to the requirements of the APA, OSHA 
must ensure that its proposed regulations adhere to, inter 
alia, guidelines specified in Executive Orders, the Paperwork 
Reduction Act,\7\ Regulatory Flexibility Act.\8\ the Small 
Business Regulatory Enforcement Fairness Act, ultimately, with 
the Congressional intent of the law of its underlying\9\ 
authorizing statute.\10\
---------------------------------------------------------------------------
    \6\5 U.S.C. Sec. 5 et seq.
    \7\See 44 U.S.C. Sec. 3501 et seq.
    \8\See 5 U.S.C. Sec. 601 et seq.
    \9\See 5 U.S.C. Sec. 801 et seq.
    \10\Moreover, as a matter of practice, in recent years it has 
become a near-certainty that one or more stakeholders affected by a 
rule will pursue a legal challenge to OSHA's final regulation. These 
challenges may result in a rule being upheld in its entirety; modified 
in some form or fashion by the courts; or struck down in its entirety. 
Once the final disposition of any legal challenges have been reached, a 
final rule is either implemented or revised according to court 
direction and subsequently administered by the Secretary of Labor 
through OSHA.
---------------------------------------------------------------------------
    While the standard-setting process and the legal framework 
in which it operates have been criticized by some for its 
deliberate pace, it has nonetheless served to ensure that any 
agency sets standards based on hard evidence, sound science, 
and robust stakeholder input. It is within this framework that 
the Committee addresses the question of whether and how OSHA 
should regulate exposure to the chemical diacetyl in the 
workplace.

         RESEARCH AND REGULATORY ACTIVITY RELATING TO DIACETYL

    Diacetyl is a chemical compound commonly used in the 
production of butter-flavored popcorn, but also used in a wide 
range of other products, such as baked goods and snacks.
    In 2000, the National Institute for Occupational Safety and 
Health (NIOSH) was asked by the State of Missouri's Department 
of Health and Senior Services to provide technical assistance 
in conjunction with its investigation of workers at a Jasper, 
Missouri microwave popcorn plant who were suffering from 
obstructed lung function, specifically the condition 
bronchiolitis obliterans, potentially relating to exposure to 
diacetyl. Following up on its interim 2001 report, in December 
2003, NIOSH published an alert entitled ``Preventing Lung 
Disease in Workers Who Use or Make Flavorings,'' which 
recommended that employers control worker exposure to diacetyl. 
In 2004, the Flavor and Extract Manufacturers Association 
(FEMA) similarly published recommendations to control workers' 
exposure to diacetyl in the workplace.
    In January, 2006, NIOSH released its final investigative 
report on the Jasper facility, in which it determined that 
inhalation exposure to butter flavoring chemicals presents a 
risk for occupational lung disease. To date, however, 
scientists who have been examining the occurrence of 
bronchiolitis obliterans and the issues surrounding diacetyl 
exposure have not recommended an exposure standard. In 
February, 2006, NIOSH experts published this conclusion in the 
Journal of Occupational and Environmental Medicine:

          At this time, insufficient data exist on which to 
        base workplace exposure standards or recommended 
        exposure limits for butter flavoring. Because the risk 
        of occupational lung disease may be partly due to 
        short-term peak exposures, an exposure limit based on 
        an 8-hour TWA [Time-Weighted Average] may not be 
        sufficient to protect workers. Moreover, because 
        flavorings are complex mixtures of many chemicals, most 
        of which have not been evaluated with respect to 
        inhalation toxicology, focusing solely on diacetyl air 
        concentrations may not be adequate to assess risk in 
        different plants using a variety of different 
        flavorings.\11\
---------------------------------------------------------------------------
    \11\See ``Evaluation of Flavorings-Related Lung Disease Risk at Six 
Microwave Popcorn Plants,'' Journal of Occupational and Environmental 
Medicine, Volume 48, Number 2, February 2006 (emphasis added).

    This lack of data notwithstanding, on July 26, 2006, the 
International Brotherhood of Teamsters (IBT) and the United 
Food and Commercial Workers (UFCW) petitioned OSHA to 
promulgate an emergency temporary standard (ETS) regulating 
diacetyl in the workplace. This petition is currently under 
consideration by OSHA.\12\
---------------------------------------------------------------------------
    \12\WUFCW has also petitioned California's state occupational 
safety and health administration (``Cal-OSHA'') to set a state 
Permissible Exposure Limit (PEL) for diacetyl. Rather than implementing 
an emergency temporary standard, Cal-OSHA has referred the matter for 
further study. NIOSH has been working in a consulting mode with Cal-
OSHA on this matter.
---------------------------------------------------------------------------

                   OSHA ACTIVITY RELATING TO DIACETYL

    On April 24, 2007, the Committee on Education and Labor 
Subcommittee on Workforce Protections held a hearing entitled 
``Have OSHA Standards Kept up with Workplace Hazards?'' While 
not devoted exclusively to the question of diacetyl regulation, 
the issue was discussed in detail by witnesses. At that 
hearing, Department of Labor Assistant Secretary for 
Occupational Safety and Health Edwin G. Foulke, Jr. testified 
at length as to the actions that his agency had taken with 
respect to diacetyl regulation. As Secretary Foulke recounted:

          In 2001, OSHA took immediate action when the hazard 
        of butter flavorings containing diacetyl was brought to 
        the Agency's attention by NIOSH's interim report on 
        microwave popcorn manufacturing plants. The report's 
        findings indicated that uncontrolled exposure to butter 
        flavorings containing diacetyl was associated with the 
        development of a severe obstructive lung disease called 
        bronchiolitis obliterans.
        OSHA promptly alerted its Regional Administrators and 
        Area Directors to NIOSH's findings and instructed its 
        field personnel to look into the issue when 
        encountering individuals working around butter 
        flavoring in popcorn manufacturing. OSHA's Region VII 
        published a brochure on this topic and arranged for its 
        distribution in the region. In 2004, OSHA issued a 
        memorandum to senior field managers and encouraged them 
        to contact employers in their regions who may have 
        workers exposed to this potential hazard.
          To further protect workers who may be exposed to this 
        hazard, OSHA is finalizing a National Emphasis Program 
        (NEP) for butter flavorings containing diacetyl in the 
        manufacturing of microwave popcorn. The goal is to 
        direct inspections to the facilities where workers may 
        be at the greatest risk of exposure to this hazard. In 
        addition, the NEP contains elements aimed at educating 
        stakeholders about the hazard posed by butter 
        flavorings containing diacetyl. Implementation of this 
        NEP would allow OSHA to begin inspecting microwave 
        popcorn manufacturing facilities by the end of May, and 
        to inspect every such facility under Federal 
        jurisdiction by the end of this year. This will be 
        followed by a second NEP that focuses on establishments 
        manufacturing food flavorings containing diacetyl.
          OSHA is also developing guidance to alert employers 
        and workers to the potential hazards associated with 
        food flavorings containing diacetyl. The guidance will 
        provide recommendations on how to control these hazards 
        and to ensure that information about those hazards is 
        effectively communicated to workers.
          The Agency is currently reviewing the petition for an 
        Emergency Temporary Standard and is engaged in site 
        visits to microwave popcorn and flavor manufacturing 
        facilities in order to fairly evaluate the merits of 
        the petitioner's request.\13\
---------------------------------------------------------------------------
    \13\Foulke Testimony at 5.

    On April 24, 2007, OSHA announced its establishment of a 
National Emphasis Program (NEP) to address the hazards and 
control measures associated with working in the microwave 
popcorn industry where butter flavorings containing diacetyl 
are used. Under the NEP, OSHA will target inspection resources 
to workplaces where potential exposure to diacetyl is greatest. 
Research by NIOSH and other occupational safety and health 
experts as to the effects of diacetyl, its relationship (if 
any) to bronchiolitis obliterans, and recommended exposure 
tolerances continues today.

       H.R. 2693, THE POPCORN WORKERS LUNG DISEASE PREVENTION ACT

    On June 13, 2007, Workforce Protections Subcommittee Chair 
Woolsey introduced H.R. 2693, which would direct OSHA to issue 
standards regulating worker exposure to diacetyl. Specifically, 
H.R. 2693 would require OSHA to set an interim final standard 
relating to diacetyl exposure within 90 days of passage, and 
promulgate a final rule (including a Permissible Exposure Limit 
or ``PEL'') for diacetyl within two years of the date of 
enactment. The interim final rule would apply to flavor 
manufacturers who manufacture, use, handle, or process diacetyl 
and all microwave popcorn production and packaging 
establishments that use diacetyl, and would be based on NIOSH's 
2003 alert.
    Under the bill, OSHA's interim final rule must include 
requirements for:
     Engineering, work practice controls, and 
respiratory protection to minimize worker exposure to diacetyl;
     Written exposure control plans outlining specific 
measures to minimize exposure;
     Biannual medical surveillance when abnormal 
pulmonary functions indicate employees have been exposed to 
diacetyl, with appropriate medical evaluation;
     Airborne exposure assessments;
     Personal protective equipment for workers exposed 
to diacetyl; and
    Written safety and health plan for training employees and 
hazard communication.
    Within two years of enactment, the bill requires OSHA to 
set a final standard which incorporates the elements of the 
interim standard set forth above and establishes a PEL for 
diacetyl. This exposure limit will apply to all facilities 
where diacetyl is processed or used, expanding application of 
the standard from diacetyl manufacturers and microwave popcorn 
facilities to all food production facilities.

                  COMMITTEE CONSIDERATION OF H.R. 2693

    No legislative hearing on H.R. 2693 was held in the 
Committee on Education and Labor subcommittee of jurisdiction, 
the Subcommittee on Workforce Protections.
    No legislative hearing on H.R. 2693 was held in the 
Committee on Education and Labor.
    The Subcommittee on Workforce Protections did not meet to 
consider H.R. 2693.
    On Wednesday, June 20, 2007, the Committee on Education and 
Labor met to consider and mark up H.R. 2693. An Amendment in 
the Nature of a Substitute offered by Representative Woolsey 
was adopted without objection. Two additional amendments were 
offered by Representative Joe Wilson of South Carolina. The 
first Wilson Amendment was withdrawn by unanimous consent. The 
second Wilson Amendment was adopted by the Committee. The 
Committee favorably reported H.R. 2693, as amended, by voice 
vote.

                            REPUBLICAN VIEWS

    Over the course of its thirty-five year history, a robust 
body of law governing the regulatory standard-setting process 
utilized by OSHA has been developed under the OSH Act. 
Congress, courts, and the agency's own directives have created 
a system to which its regulatory activities must conform, and 
which guarantee that any regulation is measured against a 
standard of technical feasibility, economic feasibility, and 
the agency's overarching mission to protect workers from 
recognized hazards, while providing for the input of all 
stakeholders and affected parties. As one of the nation's most 
experienced OSHA practitioners explained at the Committee's 
April 24 hearing:

          [T]he OSHA statute, as interpreted by decades of case 
        law, requires the agency to make detailed findings of 
        significant risk of material impairment of employee 
        health before it can pursue regulation of a workplace 
        hazard. In addition, OSHA must gather credible evidence 
        with respect to the technological and economic 
        feasibility of its regulations, and it must do so 
        industry by industry. Finally, it must perform what 
        amounts to a cost benefit analysis. These are not 
        simple tasks and to do them in a cursory fashion is to 
        invite court rejection of OSHA standards.\14\
---------------------------------------------------------------------------
    \14\Testimony of Baruch A. Fellner, Committee on Education and 
Labor Subcommittee on Workforce Protections Hearing, ``Have OSHA 
Standards Kept up with Workplace Hazards?'' (April 24, 2007), at 1 
(citations omitted).

    This well-developed system of checks, balances, and 
transparency counsels an abundance of caution before Congress 
places itself in the role of regulatory standard writer 
mandates a standard or outcome which fundamentally lacks an 
adequate scientific basis.\15\ Sadly, this is exactly what H.R. 
2693 does.
---------------------------------------------------------------------------
    \15\The Majority may be critical of the pace of standard setting by 
OSHA, and plainly objects to the fact that OSHA has not set an 
emergency temporary standard (ETS) for diacetyl, as petitioned for by 
representatives of organized labor. That objection notwithstanding, it 
is worth noting that the ETS process itself has a mixed history of 
success. Of the nine emergency temporary standards issues by OSHA in 
its history, five of these were challenged in court. OSHA lost four of 
those five challenges.
---------------------------------------------------------------------------
    Most telling and troubling is the principle at the core of 
the legislation. Scientists who have been examining the 
occurrence of bronchiolitis obliterans and the issues 
surrounding exposure have not recommended an exposure standard 
for diacetyl, nor, as noted above by NIOSH, does there yet 
exist scientific data sufficient to do so. Despite this fact, 
H.R. 2693 directs OSHA to set a permissible exposure limit for 
diacetyl when there is no clear and convincing science to 
indicate what a PEL should be.
    To date, there is no standard by a public or private 
standard-setting organization for diacetyl. Further, within the 
scientific community, many have expressed concern that while 
diacetyl is a ``marker'' for bronchiolitis obliterans, it may 
not be the true or sole cause of lung obstruction. As detailed 
more fully under the discussion of the second Wilson Amendment 
below, it may well be that exposure to diacetyl, in concert 
with other chemical flavorings, that is harming workers.
    These concerns have been repeatedly underscored. The 
American Society of Safety Engineers (ASSE), while supportive 
of the legislation, has highlighted the lack of science 
problem: ``ASSE does recognize, however, that there are wide 
gaps in industry's knowledge on this issue, as the NIOSH alert 
itself indicates.'' Similarly, the Institute for Risk 
Assessment Sciences has found that ``A relation between lung 
function abnormalities and exposure to diacetyl could not be 
established.''\16\ Without conclusive evidence, H.R. 2693 
forces OSHA to undertake a regulatory action for which it has 
no justification.
---------------------------------------------------------------------------
    \16\Institute for Risk Assessment Sciences, ``Respiratory effects 
in workers of a diacetyl production plant with a special focus on 
bronchiolitis obliterans: An evaluation among currently working and 
retired workers,'' Final Report (December 30, 2005).
---------------------------------------------------------------------------
    By circumventing the regulatory process,\17\ it is unclear 
if the legislation's intent will be achieved. Put more simply, 
the mandate of a regulation by Congressional fiat does nothing 
to ensure that workers are ultimately protected in the most 
effective way. Indeed, H.R. 2693 in many instances sets before 
OSHA tasks that simply cannot be accomplished in the time 
provided for under the bill. As stated to the Committee by 
Assistant Secretary Foulke:
---------------------------------------------------------------------------
    \17\H.R. 2693's circumvention of regular order and legislative 
process also deserves mention here. Had the bill proceeded by way of a 
legislative hearing, concerns expressed by the Minority in these 
views--and equally important, concerns raised by OSHA itself--perhaps 
could have been aired and addressed.

          The expanded scope of the final rule and the lack of 
        knowledge about the industries that use diacetyl will 
        lead to superficial analysis that may fail to provide 
        needed worker protection. H.R. 2693 would require OSHA 
        to expand the scope of the final rule to include all 
        establishments where there is potential for exposure to 
        diacetyl. Unfortunately, little is known about 
        industries--other than the microwave popcorn 
        manufacturing and food flavoring manufacturing 
        industries--that use diacetyl and diacetyl-containing 
        flavorings. OSHA would need to identify those companies 
        that use diacetyl, then conduct site visits to gather 
        needed data to (1) identify processes where exposures 
        occur, (2) develop control strategies for each process, 
        and (3) identify employers who have implemented control 
        strategies to determine if those control strategies are 
        effective.. . . OSHA believes that two years is too 
        short a period of time to develop the information base 
        and analysis necessary to adequately support the 
        proposed and final rule, and to afford the public 
        adequate time to comment on OSHA's proposal.\18\
---------------------------------------------------------------------------
    \18\Letter to Chairman George Miller from Edwin G. Foulke, Jr., 
Department of Labor Assistant Secretary for Occupational Health and 
Safety (June 19, 2007) (emphasis added). A full copy of this letter is 
attached to these Views as Appendix A.

    In addition, H.R. 2693 requires OSHA to rely on non-
scientific documents as the underpinnings of an interim final 
standard which, while helpful, simply do not live up to that 
---------------------------------------------------------------------------
task. Again, as noted by OSHA:

          As drafted, the bill would require the interim final 
        rule to impose engineering requirements based on NIOSH 
        recommendations that lack the clarity and specificity 
        necessary to form the basis of a new health standard. 
        H.R. 2693 would direct OSHA to issue an interim rule at 
        least as stringent as the 2004 NIOSH Hazard Alert. The 
        NIOSH recommendations serve as good general 
        recommendations, but do not provide specific 
        performance criteria that would be necessary to develop 
        an unambiguous and enforceable interim rule.\19\
---------------------------------------------------------------------------
    \19\Id. (emphasis added).

    Others have similarly expressed strong concern about the 
lack of data upon which to set a standard as well as the 
circumvention of the regulatory process embodied in H.R. 2693. 
The OSHA Fairness Coalition, an association of employers and 
trade groups which seeks to ensure fairness and balance in 
---------------------------------------------------------------------------
OSHA's rulemaking, put it most clearly:

          This bill would establish a regulation even though 
        the science and data available are insufficient to 
        support a regulation. Such a mandate would be 
        completely at odds with all other laws, judicial 
        decisions, executive orders and sound policy 
        considerations under which OSHA currently operates.
          This bill mandates that OSHA issue an interim final 
        regulation within 90 days of enactment, and a final 
        regulation which would include a Permissible Exposure 
        Limit (PEL), within two years of enactment. 
        Unfortunately, no data currently exist as to where such 
        a line could be drawn. The very NIOSH document cited in 
        the bill for the recommendations that are to be 
        enshrined in the OSHA regulation also states with 
        respect to diacetyl and other flavorings: ``Little is 
        currently known about which chemicals used flavorings 
        have the potential to cause lung disease and other 
        health effects, and what workplace exposure 
        concentrations are safe. . . . Most chemicals used in 
        flavorings have not been tested for respiratory 
        toxicity via the inhalation route, and occupational 
        exposure limits have been established for only a 
        relatively small number of these chemicals.''
          Most importantly, this bill would completely ignore 
        the carefully developed, balanced, and necessary 
        requirements for rulemaking that Congress and the 
        courts have put in place to make sure OSHA standards 
        reflect the best science available, are responsive to a 
        specific hazard, and are both technologically and 
        economically feasible for the affected employers. Both 
        Congress and the Supreme Court have made clear that 
        OSHA can regulate only after it has satisfied specific 
        requirements for data and analysis.\20\
---------------------------------------------------------------------------
    \20\Letter to Members of Committee on Education and Labor from OSHA 
Fairness Coalition (June 19, 2007) (citation omitted; emphases added).

    Similarly, the American Bakers Association has expressed 
---------------------------------------------------------------------------
its strong concern with this legislation to the Committee:

          Mandating specific requirements that OSHA must 
        include in a diacetyl standard sets a precedent that 
        should be avoided. Congress's role as set forth in the 
        OSH Act of 1970 is to ``assure so far as possible every 
        working man and woman in the Nation safe and healthful 
        working conditions and to preserve our human 
        resources.'' However, it is the role of the Department 
        of Labor to use its expertise for implementing 
        regulations).\21\
---------------------------------------------------------------------------
    \21\Letter to Chairman Miller from American Bakers Association 
(June 19, 2007) (emphasis added).

    Committee Republicans, regulators, and the regulated 
community are unanimous in their view that regulation of 
diacetyl may be warranted--but equally clear that the 
scientific evidence that answers that question, or counsels how 
best to regulate, is simply not available at this time. 
Particularly where, as here, science does not yet suggest, let 
alone dictate, the best outcome, Congress should not interject 
itself in the process of micromanaging regulatory agencies, or 
substituting its view for reliable and objective analysis.

 CALIFORNIA IS NOT MOVING AHEAD TO REGULATE DIACETYL IN THE ABSENCE OF 
                          APPROPRIATE SCIENCE

    One final argument bears particular note. The Majority 
attempts to justify the intervention of federal OSHA in the 
absence of appropriate science by suggesting that the State of 
California is moving more quickly, and that the federal 
government should follow suit. This argument misses the mark.
    Foremost, California is not moving with any more or less 
urgency on the regulation of diacetyl than federal OSHA. The 
California Assembly passed legislation to urge Cal-OSHA to make 
the regulation of diacetyl a high priority, but affirmatively 
opted not to impose a date certain for the completion of a 
regulation. California's regulatory body also did not set an 
exposure standard, and is instead working toward setting a 
standard that largely relies on engineering controls to control 
exposure--far less than that contemplated by H.R. 2693. 
Finally--and as noted at hearing--the simple fact is that OSHA 
and California's state regulatory agencies do not have the same 
regulatory processes and are not subject to the same 
constraints. In response to questioning by Chairwoman Woolsey, 
Assistant Secretary Foulke elucidated these differences:

          Well, you know, with respect to California, I would 
        just have to say that we have different statutory and 
        legal burdens to support our rulemaking effort that 
        California does not have. . . . I would submit to you 
        that if you look at the regulatory process that we have 
        in place under the federal system, as opposed to 
        California, we have things that the Congress has put 
        in--Administrative Procedures Act. We have things in 
        the OSH Act that we have to follow, so those are just 
        three of the things that the Congress has intended.
          And all those things were put on for specific 
        reasons, that the Congress, in its wisdom said, ``You 
        know, we have got to look at these things, because we 
        can't rush into a standard, unless we have sound 
        science.'' And I know that is what you want to have.
          Plus, on top of that, the court systems, as part of 
        their review process on these things, have indicated 
        that we have to do certain other things on feasibility 
        and risk assessment.\22\
---------------------------------------------------------------------------
    \22\Foulke Testimony, at__(not yet printed).

    As a general matter, and specifically in this instance, to 
assert that there should be a race to promulgate a regulation, 
for which the science is simply science, is bad public policy.

                    AMENDMENTS OFFERED IN COMMITTEE

Woolsey Amendment in the nature of a substitute

    An Amendment in the Nature of a Substitute offered by 
Workforce Protections Subcommittee Chair Woolsey was adopted 
without objection. The Woolsey Amendment simply provided a 
short title for H.R. 2693, the ``Popcorn Workers Lung Disease 
Prevention Act.''

Wilson Amendment to require scientific data supporting a rulemaking

    As noted above, NIOSH has stated--and no party has 
seriously disputed--that the current state of scientific data 
concerning diacetyl offers an insufficient basis on which to 
set a workplace exposure standard. For this reason, and to 
ensure that any workplace standard set by OSHA was based on 
scientific evidence, during Committee consideration of the bill 
Representative Joe Wilson of South Carolina offered an 
amendment which would have: (a) required NIOSH to set a 
recommended exposure limit (REL) for diacetyl when the 
scientific evidence so warranted; and (b) provided that OSHA 
would have two years from that time to set a permissible 
exposure limit based on NIOSH's findings.
    The Wilson Amendment would have allowed the interim final 
rule contained in H.R. 2693 to become effective as scheduled 
under the bill, while ensuring that any standard set by OSHA 
would have been based on the best available science and still 
allowing for robust stakeholder input. At markup, the Majority 
expressed a willingness to work with Committee Republicans in 
fashioning a compromise that might serve these goals. Based on 
this representation, the Wilson Amendment was withdrawn without 
objection.\23\
---------------------------------------------------------------------------
    \23\At the time of the filing of these Minority Views, discussions 
as to a possible compromise continue on a staff level. To date, 
however, they have not produced a consensus position.
---------------------------------------------------------------------------

Wilson Amendment to require NIOSH to gather data as to other flavorings

    As discussed above, scientific evidence is inconclusive as 
to diacetyl's causal link to bronchiolitis obliterans, and in 
particular, whether a risk of lung damage is presented by 
diacetyl, any related compounds, or some combination of both.
    Given this lack of information, during Committee 
consideration, Representative Wilson offered an amendment which 
directs NIOSH to study flavorings that have a chemical make up 
similar to diacetyl, so as to determine exposure hazards (if 
any) and, where appropriate, set recommended exposure limits. 
The amendment further directs NIOSH to inform OSHA of its 
findings, so that all parties have this evidence for use in 
future regulation. The Wilson Amendment was accepted without 
objection.

                               CONCLUSION

    Committee Republicans recognize that the question of 
whether and how OSHA should regulate worker exposure to 
diacetyl in the workplace is one on which Members on both sides 
of the aisle can in good conscience disagree. Committee 
Republicans are united, however, in their view that any 
workplace regulation, however well intended, must be supported 
by objective evidence, sound science, and reliable data. To do 
less threatens the thirty-five years of accomplishment achieved 
under the OSH Act, and, far worse, does nothing to protect the 
health and safety of American workers.
    Measured against those standards, H.R. 2693 is, foremost, 
fundamentally flawed policy with respect to the discrete issue 
of whether and how to federally regulate exposure to diacetyl. 
Equally important, in the larger context, it sets an 
unfortunate precedent for the consideration of future workplace 
safety standards. H.R. 2693 short-circuits the rulemaking 
process and thereby eliminates many of the critical features of 
rulemaking under the OSH Act which serve to guarantee that 
regulation is based on sound science, stakeholder input, and 
the best evidence available. At bottom, the bill is based on 
incomplete evidence as to appropriate workplace exposure 
controls and standards, and, perhaps most disappointing, 
provides no guarantee that workers will enjoy greater 
protection from the risk of bronchiolitis obliterans.
    For all of these reasons, we respectfully oppose this 
legislation.

                                   Howard P. McKeon.
                                   Peter Hoekstra.
                                   Mark Souder.
                                   Judy Biggert.
                                   Joe Wilson.
                                   John Kline.
                                   K. Marchant.
                                   Thomas Price.
                                   Luis Fortuno.
                                   C. W. Boustany, Jr.
                                   Rob Bishop.
                                   David Davis.
                                   Tim Walberg.
                                   Ric Keller.
                               APPENDIX A

                              ----------                              

        U.S. Department of Labor, Assistant Secretary for 
            Occupational Safety and Health,
                                    Washington, DC., June 19, 2007.
Hon. George Miller,
Chairman, Committee on Education and Labor,
House of Representatives, Washington, DC.
    Dear Chairman Miller: I am writing to express my strong 
concerns with legislation (H.R. 2693) that would require the 
promulgation of an interim final standard (IFR) regulating 
employee exposure to diacetyl in the popcorn and flavor 
manufacturing industries and mandate that the Occupational 
Safety and Health Administration (OSHA) issue a final rule 
covering all workplaces that use diacetyl.
    I share your goal of protecting workers from the risk of 
obstructive lung disease. As outlined below, OSHA is in the 
process of taking important steps to strengthen worker 
protections in this area. However, after careful review of this 
legislation, we have concluded that the regulatory approach 
mandated by H.R. 2693 will not afford the best level of 
protection for workers. Equally important, the process the bill 
would require may result in missed opportunities to provide 
needed worker safety. Instead, I urge you to allow OSHA to 
thoroughly evaluate all available science concerning the 
effects of exposures to food flavorings, feasible abatements, 
and related issues.
    Several considerations lead us to the conclusion that the 
approach mandated by H.R. 2693 would not best protect workers:
    1. The expanded scope of the final rule and the lack of 
knowledge about the industries that use diacetyl will lead to 
superficial analysis that may fail to provide needed worker 
protection.
    H.R. 2693 would require OSHA to expand the scope of the 
final rule to include all establishments where there is 
potential for exposure to diacetyl. Unfortunately, little is 
known about industries--other than the microwave popcorn 
manufacturing and food flavoring manufacturing industries--that 
use diacetyl and diacetyl-containing flavorings. OSHA would 
need to identify those companies that use diacetyl, then 
conduct site visits to gather needed data to (1) identify 
processes where exposures occur, (2) develop control strategies 
for each process, and (3) identify employers who have 
implemented control strategies to determine if those control 
strategies are effective, Although OSHA has been obtaining this 
information for microwave popcorn and food flavoring 
manufacturing establishments, to date little information is 
available on the many other industry sectors that would 
potentially be covered by the final rule required by the bill. 
OSHA believes that two years is too short a period of time to 
develop the information base and analysis necessary to 
adequately support the proposed and final rule, and to afford 
the public adequate time to comment on OSHA's proposaL The 
Agency believes that robust public input is essential to 
achieving a final rule that provides protection for employees 
while addressing potential impacts on all affected industries.
    2. Focusing solely on a Permissible Exposure Limit (PEL) 
for diacetyl may ignore other components that are playing an 
important role in the development of disease.
    H.R. 2693 requires OSHA to develop a PEL for diacetyl that 
would apply to all facilities where diacetyl is processed or 
used. Research is ongoing by groups such as the National 
Institute for Occupational Safety and Health (NIOSH), the 
National Jewish Medical Center, the National Institute for 
Environmental Health Studies and California Department of 
Industrial Relations; Division of Occupational Safety and 
Health (Cal OSHA) to better determine the role that exposures 
to diacetyl and other chemicals may play in the development of 
bronchiolitis obliterans.
    By focusing solely on diacetyl, H.R. 2693 raises two major 
concerns:
    a. Focusing on diacetyl ignores the possibility that other 
flavoring components--many of which are irritants and airway-
reactive substances--are playing a role in the development of 
disease. Given the wide variety of ways and forms (e.g., 
liquids or powders) in which diacetyl and other flavoring 
components are used in the food manufacturing industry, a 
narrow focus on diacetyl would likely result in the selection 
of risk management strategies that may not adequately protect 
employees. These might include substitution of diacetyl with 
other chemicals that may be as dangerous under similar 
circumstances as diacetyl.
    b. NIOSH has stated that ``at this time, insufficient data 
exist on which to base workplace exposure standards or 
recommended exposure limits for butter flavorings.'' Given the 
state of the data currently available, OSHA would only be able 
to develop an imprecise PEL for diacetyl which would have a 
considerable amount of uncertainty associated with respect to 
the degree of protection afforded.
    3. As drafted, the bill would require the interim final 
rule to impose engineering requirements based on NIOSH 
recommendations that lack the clarity and specificity necessary 
to form the basis of a new health standard.
    H.R. 2693 would direct OSHA to issue an interim rule at 
least as stringent as the 2004 NIOSH Hazard Alert. The NIOSH 
recommendations serve as good general recommendations, but do 
not provide specific performance criteria that would be 
necessary to develop an unambiguous and enforceable interim 
rule. The NIOSH Alert refers to the 2001 ACGIH Ventilation 
Manual, which provides some general objective design criteria, 
but mixing and blending processes in flavoring establishments 
vary greatly. For example, they can range from a zero-gallon 
batch operation up to several hundred pounds of batch mixing. 
Each of these operations may use similar control strategies but 
would require different engineering design parameters to 
achieve the same level of effectiveness. Therefore, the NIOSH 
Hazard Alert is not helpful to specify required minimum 
operating parameters for engineering controls because these 
minimum parameters will not provide equal protection to all 
employees in affected establishments. Furthermore, there is 
simply not enough information available at this point on 
flavoring processes and current exposure control practices to 
develop a specification-oriented standard.
    OSHA traditionally has used PELs instead of specification-
oriented standards to protect workers in this type of 
situation, because a PEL will set a precise, measurable 
standard to protect workers. However, as previously mentioned, 
currently available data do not support setting a PEL for 
diacetyl. Thus, OSHA would be forced by H.R. 2693 to issue a 
PEL based on imprecise information and an IFR based on a MOSH 
Hazard Alert that does not provide specific performance 
criteria.
    Additionally, the Department of Labor is very concerned 
that the IFR that is mandated by this legislation will not be 
open for comment by stakeholders, or reviewed in accordance 
with the requirements of the Small Business Regulatory 
Enforcement Fairness Act (SBREFA), the Administrative 
Procedures Act, and the rulemaking requirements of the 
Occupational Safety and Health Act These statutes ensure 
thorough consideration and transparency in rulemaking. We do 
not believe these regulatory requirements should be waived 
except in the most exceptional situations. Thorough vetting is 
particularly critical when the medical and scientific studies 
do not provide unequivocal conclusions.
    The Department of Labor is committed to protecting 
employees from obstructive lung diseases. The Department 
recently announced that OSHA will focus on health hazards of 
microwave popcorn butter flavorings containing diacetyl through 
a new National Emphasis Program (NEP). The NEP will direct 
inspections to the facilities where workers may be at the 
greatest risk of exposure to this hazard. Implementation of 
this NEP would allow OSHA to inspect every such facility under 
Federal jurisdiction by the end of this year. This will be 
followed by a second NEP that focuses on establishments 
manufacturing food flavorings containing diacetyl.
    In addition to the NEP1 OSHA is also preparing a Safety and 
Health Information Bulletin (SHIB) to better inform and 
instruct employers on how to protect employees from obstructive 
lung disease caused or exacerbated by food flavorings used in 
the microwave popcorn manufacturing industry. The SHIB will 
provide guidance to alert employers and workers to the 
potential hazards associated with butter flavorings containing 
diacetyl and will provide recommendations on how to control 
these hazards. OSHA is also developing a hazard communication 
guidance document to ensure that material safety data sheets 
and labels properly convey hazard information on diacetyl and 
diacetyl-containing food flavorings. Given that NIOSH has 
stated that insufficient data exist on which to base workplace 
exposure standards or recommended exposure limits for butter 
flavorings, the approach we are taking is the quickest and most 
effective means of providing protection to workers in the 
popcorn and flavor manufacturing industries.
    Because of the concerns I have outlined, the Department of 
Labor is opposed to H.R. 2693. We have concluded that the 
approach proposed by H.R. 2693 will not afford the best level 
of protection for workers. By not providing sufficient time to 
do a proper rulemaking, OSHA may unintentionally overlook 
opportunities to provide needed worker safety and, at the same 
time, require expensive process isolation, and ventilation and 
other control strategies that may be ineffective. Instead, I 
urge you to allow OSHA to thoroughly evaluate all available 
science concerning the effects of exposures to food flavorings, 
feasible abatements, and related issues.
            Sincerely,
                                               Edwin G. Foulke, Jr.

                                  
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