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Week Ending September 28, 2007

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

Diacetyl is an artificial compound that gives flavored popcorn its butter flavor. (The compound is used in many other flavorings, as well.) When inhaled, diacetyl causes a debilitating and life-threatening lung disease called bronchiolitis obliterans commonly referred to as ‘Popcorn Lung’.

It is now recognized that microwave popcorn workers and flavoring-manufacturing workers are now afflicted in several states resulting in various government and industry warnings to those workers.

Because the hazard of the stuff can be controlled, labor organizations and leading scientists are calling for an emergency temporary standard from OSHA.

OSHA, however, has not acted on the standards determined in the bill to be urgently needed to protect workers.

The bill, then directs the Secretary of labor to, within 90 days, promulgate an interim standard regulating worker exposure to diacetyl and apply it to all locations in the flavoring manufacturing industry that make use or handle the stuff and to all microwave popcorn production and packaging establishments that use it.

The standards shall require no less protection than earlier warnings and shall include requirements for engineering, work practice controls and respiratory protection to minimize exposure. The standards must also require a plan to minimize exposure and evaluation of the exposure plan to determine its effectiveness on at least a biannual basis and whenever medical surveillance indicates abnormal pulmonary function in exposed employees. Protective clothing and equipment, written and safety and health education training to employees, and labeling are also required.

A final standard must be implemented in two years.

The National Institute of Occupational Safety and Health is directed to conduct a study on food flavorings used in the production of microwave popcorn and prioritize the chemicals most closely associated with diacetyl, recommend exposure limits for workers.

The first case of Popcorn Lung was identified in a Missouri microwave popcorn plant in 2000 and the case was linked to diacetyl shortly there after. Since then OSHA has not taken any significant action to prevent worker exposure, the bill report noted.

Sponsor:  Rep. Lynn Woolsey (D-CA-6^th)

Vote: Passed House September 25, 2007 260 to 154 with 2 voting 'Present' RC 913

Cost to the taxpayers: 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.

Earmark Certification:   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.## All Rights Reserved. © 2007 TheWeekInCongress.com(TM)

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MORE INFORMATION

AMENDMENTS

Amendment offered by Mr. George Miller.

An amendment numbered 1 printed in House Report 110-349 to clarify that a standard will only beneeded if diacetyl is still in use. Second, it clarifies that Section 4, calling for a NIOSH study, applies to potential substitutes for diacetyl.

Agreed to by Voice vote

Amendment offered by Mr. Wilson (SC).

An amendment numbered 2 printed in House Report 110-349 to require the Occupational Safety and Health Administration to wait until the National Institute for Occupational Safety and Health (NIOSH) concludes there is sufficient data to support a recommended exposure limit and establishes such recommended exposure limit before issuing a final standard.

Passed RC 912 `898 to 233

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

[Footnote]

[Footnote 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

[Footnote] 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.

[Footnote 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

[Footnote]

[Footnote 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

[Footnote]

[Footnote 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

[Footnote]

[Footnote 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

[Footnote]

[Footnote 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

[Footnote]

[Footnote 7: Sarah Shipley, `Study Showed Chemical was Toxic,' St. Louis Post Dispatch (Feb. 28, 2004).]

Linda Redman died April 30, 2006. 8

[Footnote]

[Footnote 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

[Footnote]

[Footnote 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

[Footnote] 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

[Footnote]

[Footnote 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.]

[Footnote 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

[Footnote]

[Footnote 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

[Footnote]

[Footnote 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

[Footnote]

[Footnote 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

[Footnote]

[Footnote 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

[Footnote]

[Footnote 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

[Footnote]

[Footnote 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

[Footnote]

[Footnote 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

[Footnote]

[Footnote 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

[Footnote] And a study of the effects of diacetyl on the respiratory tracts of mice also showed respiratory damage. 21

[Footnote]

[Footnote 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.]

[Footnote 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

[Footnote]

[Footnote 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

[Footnote]

[Footnote 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

[Footnote]

[Footnote 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

[Footnote]

[Footnote 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

[Footnote]

[Footnote 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

[Footnote]

[Footnote 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

[Footnote]

[Footnote 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

[Footnote]

[Footnote 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

[Footnote]

[Footnote 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

[Footnote]

[Footnote 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

[Footnote]

[Footnote 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

[Footnote]

[Footnote 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

[Footnote]

[Footnote 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

[Footnote]

[Footnote 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 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

[Footnote]

[Footnote 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

[Footnote]

[Footnote 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

[Footnote] 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

[Footnote] 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.

[Footnote 38: 29 U.S.C. 655(b)(5).]

[Footnote 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

[Footnote]

[Footnote 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

[Footnote] 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

[Footnote]

[Footnote 41: Alabama Power Co. v. OSHA, 89 F.3d 740, 745 (11th Cir. 1996); 17 OSH Cases 1675.]

[Footnote 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

[Footnote] , the Regulatory Flexibility Act, 44

[Footnote] 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.

[Footnote 43: P.L. 104-121. Small Business Regulatory Enforcement Fairness Act of 1996.]

[Footnote 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

[Footnote]

[Footnote 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

[Footnote]

[Footnote 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

[Footnote] 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

[Footnote] 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

[Footnote] 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

[Footnote] Finally, in 2000, Congress required OSHA issue an update to the Bloodborne Pathogens standard, requiring safer syringes and sharps. 51

[Footnote] That standard was issued in 2001.

[Footnote 47: P.L. 99-499. Superfund Amendments and Reauthorization Act of 1986, Title I Sec. 126 a-f (Oct. 26, 1986).]

[Footnote 48: P.L 101-549. Title III, Sec. 304 (Nov. 15, 1990).]

[Footnote 49: P.L. 102-170. Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, Sec. 100 (1992).]

[Footnote 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.]

[Footnote 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

[Footnote]

[Footnote 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.

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