[Federal Register Volume 74, Number 12 (Wednesday, January 21, 2009)]
[Proposed Rules]
[Pages 3938-3947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-1125]
[[Page 3937]]
-----------------------------------------------------------------------
Part VII
Department of Labor
-----------------------------------------------------------------------
Occupational Safety and Health Administration
-----------------------------------------------------------------------
29 CFR Part 1910
Occupational Exposure to Diacetyl and Food Flavorings Containing
Diacetyl; Proposed Rule
Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 /
Proposed Rules
[[Page 3938]]
-----------------------------------------------------------------------
DEPARTMENT OF LABOR
Occupational Safety and Health Administration
29 CFR Part 1910
[Docket No. OSHA-2008-0046]
RIN 1218-AC33
Occupational Exposure to Diacetyl and Food Flavorings Containing
Diacetyl
AGENCY: Occupational Safety and Health Administration (OSHA),
Department of Labor.
ACTION: Advance notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: OSHA is requesting data, information, and comment on issues
related to occupational exposure to diacetyl and food flavorings
containing diacetyl, including current employee exposures to diacetyl;
the relationship between exposure to diacetyl and the development of
adverse health effects; exposure assessment and monitoring methods;
exposure control methods; employee training; medical surveillance for
adverse health effects related to diacetyl exposure; and other
pertinent subjects. In this notice, OSHA intends the term ``diacetyl
and food flavorings containing diacetyl'' to encompass other
constituents of food flavorings containing diacetyl. In addition to
information on diacetyl, OSHA seeks information on acetoin,
acetaldehyde, acetic acid, furfural, and other compounds present in
food flavorings that may cause or contribute to flavoring-related lung
disease. The Agency is also interested in and seeks information about
diacetyl present in substances other than food flavorings (e.g.,
naturally occurring diacetyl or diacetyl in fragrances) as well as
substitutes used in place of diacetyl (e.g., diacetyl trimer). The
information received in response to this document will assist the
Agency in developing a proposed standard addressing occupational
exposure to diacetyl and food flavorings containing diacetyl.
DATES: Comments must be submitted (postmarked, sent, or received) by
April 21, 2009.
ADDRESSES: You may submit comments, identified by Docket No. OSHA-2008-
0046, by any of the following methods:
Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
Fax: If your comments, including attachments, do not exceed 10
pages, you may fax them to the OSHA Docket Office at 202-693-1648.
Mail, hand delivery, express mail, messenger or courier service:
You must submit three copies of your comments and attachments to the
OSHA Docket Office, Docket No. OSHA-2008-0046, Room N-2625, U.S.
Department of Labor, 200 Constitution Avenue, NW., Washington, DC
20210; telephone 202-693-2350 (TTY number 877-889-5627). Deliveries
(hand, express mail, messenger or courier service) are accepted during
the Department of Labor's and Docket Office's normal business hours,
8:15 a.m.-4:45 p.m., e.t.
Instructions: All submissions must include the Agency name and the
OSHA docket number (Docket No. OSHA-2008-0046). Because of security-
related procedures, submissions by regular mail may result in
significant delay in their receipt. Please contact the OSHA Docket
Office at the above address for information about security procedures
for submitting comments by hand delivery, express delivery, and
messenger or courier service.
All comments, including any personal information you provide, are
placed in the public docket without change and may be made available
online at http://www.regulations.gov. Therefore, OSHA cautions you
about submitting certain personal information, such as social security
numbers and birthdates. For further information on submitting comments,
see the ``Public Participation'' heading in the SUPPLEMENTARY
INFORMATION section of this document.
Docket: To read or download comments submitted in response to this
Federal Register notice or other materials in the docket, go to Docket
No. OSHA-2008-0046 at http://www.regulations.gov or the OSHA Docket
Office at the address above. All documents in the docket are listed in
the http://www.regulations.gov index, however, some information (for
example, copyrighted material) is not publicly available to read or
download through the Web site. All submissions, including copyrighted
material, are available for inspection and copying at the OSHA Docket
Office.
Electronic copies of this Federal Register notice are available at
http://www.regulations.gov. This notice, as well as news releases and
other relevant information, also are available at OSHA's Web site at
http://www.osha.gov.
FOR FURTHER INFORMATION CONTACT:
Press Inquiries: Jennifer Ashley, OSHA Office of Communications,
Room N-3647, U.S. Department of Labor, 200 Constitution Avenue, NW.,
Washington, DC 20210; telephone: 202-693-1999.
General and Technical Information: David O'Connor, OSHA Directorate
of Standards and Guidance, Office of Chemical Hazards--Non-Metals, Room
N-3718, U.S. Department of Labor, 200 Constitution Avenue, NW.,
Washington, DC 20210; telephone 202-693-2090.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. Events Leading to This Action
B. Properties and Uses
C. Health Effects Studies of Exposure to Butter Flavorings and
Diacetyl
II. Request for Data, Information, and Comment
A. Production and Uses
B. Employee Exposure
C. Health Effects
D. Risk Assessment
E. Exposure Assessment and Monitoring Methods
F. Control Measures
G. Employee Training
H. Medical Surveillance Programs
I. Environmental Impacts
J. Economic Impacts
K. Impacts on Small Entities
L. Duplication/Overlapping/Conflicting Rules
M. Approaches to Regulation
III. Public Participation
IV. References
V. Authority and Signature
In this document, OSHA references a number of supporting materials,
and includes a list of these materials (see Section IV--References).
These materials are posted in Docket No. OSHA-2008-0046. See ADDRESSES
section above and Section III (Public Participation) for further
information about accessing exhibits referenced in this Federal
Register notice.
I. Background
A. Events Leading to This Action
On July 26, 2006, the United Food and Commercial Workers
International Union and the International Brotherhood of Teamsters
petitioned OSHA for an Emergency Temporary Standard (ETS) covering all
employees exposed to diacetyl. The petition cited evidence from NIOSH
Health Hazard Evaluations to show that some employees exposed to butter
flavorings developed bronchiolitis obliterans, a serious and sometimes
fatal lung disease. OSHA denied the ETS petition on September 25, 2007,
indicating that the evidence available at that time did not support the
stringent legal findings required for an ETS. However, the
[[Page 3939]]
Agency acknowledged that the available evidence showed that employees
exposed to butter flavoring vapors containing diacetyl may be at risk
of material impairment, and initiated rulemaking under Section 6(b) of
the Occupational Safety and Health Act of 1970 (29 U.S.C. 651, 655).
The information available to date indicates that regulating
occupational exposures to diacetyl and food flavorings containing
diacetyl presents a number of complex and difficult issues. Flavorings,
including butter flavoring, are complex mixtures and may contain a
number of potential airway reactive substances (e.g., diacetyl,
acetoin, acetaldehyde, acetic acid, furfural). Diacetyl has been used
as an indicator of exposure to butter flavoring vapors in a variety of
occupational studies in microwave popcorn plants. While there is
evidence that diacetyl is a factor in flavoring-related airway injury,
other compounds may contribute to the development of obstructive airway
disease and bronchiolitis obliterans. Gaps also exist in the available
data on current usage of and exposure to diacetyl and food flavorings
containing diacetyl.
As part of the information-gathering process, OSHA hosted a
stakeholder meeting on October 17, 2007. The meeting provided OSHA
representatives and stakeholders an opportunity for informal
discussion, open conversation, and the exchange of data, ideas, and
points of view regarding occupational exposure to diacetyl and food
flavorings containing diacetyl. The meeting addressed not only specific
OSHA information requests, but also identified stakeholder concerns
associated with developing a standard addressing occupational exposure
to diacetyl and food flavorings containing diacetyl. A summary report
of this stakeholder meeting is available in the docket and on OSHA's
Web page (OSHA, 2007a).
OSHA has initiated a number of enforcement and compliance
assistance activities. On July 27, 2007, the Agency announced a
National Emphasis Program requiring inspections of all workplaces where
butter flavored microwave popcorn is produced (OSHA, 2007b). OSHA has
published a Safety and Health Information Bulletin that addresses
respiratory disease among employees in microwave popcorn processing
plants (OSHA, 2007c). The Agency has also published a guidance document
that addresses responsibilities of flavoring manufacturers and
employers who must comply with OSHA's Hazard Communication Standard
with regard to diacetyl and food flavorings that contain diacetyl
(OSHA, 2007d).
In this notice, OSHA is seeking information to help the Agency
resolve some of the issues discussed above. OSHA believes that its
decisionmaking process will benefit from gathering public input on
relevant studies and scientific information; data regarding the
frequency, intensity, duration, and other parameters of employee
exposure in the affected industries, occupations, and activities; key
default factors and assumptions; and other relevant information related
to the development of a health standard regulating occupational
exposure to diacetyl and food flavorings containing diacetyl.
B. Properties and Uses
Flavorings containing diacetyl are in a variety of foods. Of
particular note is the use of butter flavorings that contain diacetyl
in microwave popcorn. Butter flavoring is mixed with oils and other
ingredients and added to the bag during microwave popcorn production.
Both natural and artificial butter-flavored popcorn may contain
diacetyl. Diacetyl (C4H6O2, other
names: butanedione or 2,3-butanedione, CAS number 431-03-8) is an
organic chemical that occurs naturally in dairy products, and is a
natural byproduct of fermentation and brewing. It also is widely used
in flavorings, particularly flavorings designed to provide a dairy,
buttery, or ripe taste. In addition, diacetyl is used in some
fragrances.
Diacetyl can be produced several ways, including by extraction from
dairy products, fermentation processes or chemical synthesis. Under
Food and Drug Administration classifications, diacetyl produced by
extraction from natural products is classified as a natural flavoring
while diacetyl produced by other means is classified as an artificial
flavoring. There is no difference in the chemistry of ``natural'' and
``artificial'' diacetyl.
The Flavor and Extract Manufacturers Association (FEMA) estimates
that each year the U.S. flavorings industry consumes approximately
228,000 pounds of diacetyl, most of which is imported (FEMA, 2005).
Flavoring manufacturers are largely firms that mix natural and
artificial substances to create flavorings. OSHA has identified 139
establishments, employing an estimated 8,972 employees, that produce
flavorings containing diacetyl (ERG, 2007).
The principal types of flavorings that use diacetyl are dairy
flavors such as butter, cheese, sour cream, egg, or yogurt flavors; and
the so-called ``brown flavors'' such as caramel, butterscotch, brown
sugar, maple or coffee flavors. Some fruit flavors (e.g., strawberry
and banana) may also contain diacetyl. There are also a variety of
special uses of diacetyl such as in vanilla, tea, and other flavorings
that are difficult to categorize broadly.
Food flavorings containing diacetyl are used in a wide variety of
products throughout the food processing sector. In addition to
microwave popcorn, flavorings containing diacetyl are commonly used in
the production of margarine and butter-flavored oils and cooking
sprays, in retail and commercial bakeries, the production of some snack
foods (particularly those with cheese flavoring), and in many
confectionaries. Dairy, butter, and cheese flavors are sometimes used
in frozen foods, canned foods, salad dressings, cheese and dairy
substitutes, flavored wines and liquors, pet food, and specialty
preparations. Fruit flavorings containing diacetyl are used in some
yogurt and ice cream products.
When food preparation facilities and restaurants heat food and
other products containing butter-flavored margarines, oils, cooking
sprays, and butter, food preparation employees may be exposed to
diacetyl. Diacetyl is reported to be used in fragrances for some fruit
scents and for some floral scents, such as geranium and magnolia.
Diacetyl may in turn appear in some fragrance-using products such as
scented candles (Lone Star, 2003). Diacetyl also has anti-bacterial
properties and may be used as a preservative (Bibek, 2004).
Flavorings, including butter flavoring, are complex mixtures and
may contain volatile compounds, including other potential airway
reactive substances. Apart from diacetyl, one of those substances is
acetoin (C4H8O2, other names: 3-
hydroxybutanone or acetyl methyl carbonol, CAS number 513-86-0).
Acetoin is known to be used in butter flavorings and may be used in
other flavorings, including flavorings in which diacetyl is used.
Acetoin is structurally similar to diacetyl and shares common metabolic
pathways with diacetyl. It has been found in the same workplace
environments at concentrations approaching those of diacetyl. Like
diacetyl, acetoin also occurs naturally in dairy products and has uses
similar to diacetyl. Other volatile organic compounds found in some
food flavorings include acetaldehyde, acetic acid, and furfural.
Motivated by public concerns about possible health effects of
diacetyl, some flavoring and food product manufacturers have begun or
are planning to substitute other chemicals for diacetyl, since most
flavorings can
[[Page 3940]]
be made without diacetyl. For example, many microwave popcorn producers
have substituted or are seeking to substitute alternatives to diacetyl
in butter flavoring (ConAgra, 2007; Pop Weaver, 2008). OSHA has noted
three substances promoted as diacetyl substitutes--acetoin, diacetyl
trimer (OSHA, 2007a), and a sulfite adduct of diacetyl (Turin, 2007).
Both diacetyl trimer and the sulfite adduct of diacetyl have a low
vapor pressure in their basic form, and are thus less likely to
evaporate and result in employee inhalation exposures during the
production process. However, both are converted to diacetyl during
consumer food preparation, so that the foods when consumed will contain
diacetyl. For example, if placed on popcorn, both convert to diacetyl
when the popcorn is popped.
C. Health Effects Studies of Exposure to Butter Flavorings and Diacetyl
A number of studies, including several occupational investigations
and case reports, have documented obstructive airway disease among
employees exposed to airborne butter flavoring chemicals (Kanwal et
al., 2008). While cases of obstructive lung disease had been described
among employees at flavoring manufacturing sites in a few earlier
reports, the scientific community did not become aware of flavoring-
related obstructive airway disease until 2000 after a case cluster was
identified at a microwave popcorn production plant. Subsequent
investigations at microwave popcorn production plants demonstrated
higher rates of respiratory symptoms such as chronic cough, shortness
of breath, and wheezing among employees engaged in certain job
activities when compared to the rates expected among the U.S.
population adjusted for age and smoking status. In some cases, these
effects may be symptomatic of a potentially disabling obstructive lung
disease known as constrictive bronchiolitis obliterans. Higher-than-
expected rates of physician-diagnosed asthma and chronic bronchitis
have also been reported. Some employees exposed to butter flavoring
have also experienced eye, skin, nose, and throat irritation.
Spirometry surveys in the investigations of microwave popcorn
production plants revealed higher prevalences of airway obstruction,
defined as a reduction in FEV1 and FEV1/FVC
ratio,\1\ than expected based on the adjusted rates among the U.S.
population. Airway obstruction is described as fixed when abnormal
pulmonary function test results do not improve with bronchodilator
treatment. The onset of symptoms associated with fixed airway
obstruction has been reported to occur after a few months to several
years of exposure to butter flavorings that contained diacetyl in a
microwave popcorn production facility (Akpinar-Elci et al., 2004).
---------------------------------------------------------------------------
\1\ The most common pulmonary function tests, including
FEV1 and FVC, are often measured using spirometry, which
measures the flow of air in and out of the lungs. Forced expiratory
volume--one second (FEV1) is the volume of air that a
person can exhale through a mouthpiece in one second. Forced vital
capacity (FVC) is the amojunt of air that can be exhaled following
full inspiration. For accurate measurement of FVC, a person must
inhale as deeply as possible and then exhale as forcefully as
possible through a mouthpiece, for as long as posssible.
---------------------------------------------------------------------------
Fixed airway obstruction is characteristic of bronchiolitis
obliterans. This lung disease results from inflammation and scarring of
the tissue lining the small airways of the lung. In response to the
damage, the airways become thickened, narrowed, and sometimes
completely obstructed, limiting movement of air into and out of the
lung. Because it is an uncommon condition, bronchiolitis obliterans may
be misdiagnosed as the more frequently encountered obstructive lung
diseases of chronic bronchitis, emphysema, or asthma. A high resolution
computerized tomography (CT) scan or, sometimes, a specialized lung
biopsy is needed to confirm a diagnosis of bronchiolitis obliterans. As
airways become more severely damaged, employees with bronchiolitis
obliterans suffer persistent symptoms and permanent loss of pulmonary
function. Several employees with severe disease are on waiting lists to
receive lung transplants. At least three employee deaths have been
attributed to flavoring-related bronchiolitis obliterans (Egilman et
al., 2007).
Investigations of Microwave Popcorn Plants
The respiratory hazards associated with butter flavoring came under
scrutiny with the diagnosis of bronchiolitis obliterans in eight former
employees who had worked in mixing and packaging operations at a
Missouri microwave popcorn plant (Parmet et al., 2002). The National
Institute of Occupational Safety and Health (NIOSH) evaluated the
medical condition of current employees at the plant (Kreiss et al.,
2002). The prevalence of airway obstruction was 3.3 times higher than
expected for all employees and 10.8 times higher than expected for
employees who had never smoked based on national statistics. The
frequency and extent of the airway obstruction was greatest among
mixing room and packaging area employees with the highest exposures to
the butter flavoring vapors. Medical symptoms that were elevated among
production workers included chronic cough, shortness of breath upon
exertion, wheezing, physician diagnosed asthma and chronic bronchitis,
unusual fatigue, and skin and mucous membrane irritation. Rates of
physician-diagnosed asthma and chronic bronchitis were also higher than
expected based on national statistics. NIOSH noted that five of six
current employees who worked in the quality control room popping nearly
100 bags of product in microwave ovens per shift suffered airway
obstruction despite relatively low full shift exposure to butter
flavoring vapors.
NIOSH then investigated five additional microwave popcorn plants
which confirmed and extended its initial findings (Kanwal et al.,
2006). The prevalence of airways obstruction and respiratory symptoms
was highest among flavorings mixers with longer work histories and
packaging operators who worked in close proximity to mixing tanks of
oil and flavorings. Six employees currently engaged in these job
operations at four microwave popcorn plants were found to have clinical
evidence consistent with bronchiolitis obliterans. Production and non-
production employees with the least exposure to butter flavoring
chemicals had the lowest rates of airway disease and respiratory
symptoms.
As an indicator of exposure to butter flavoring vapors, NIOSH
measured full shift area and personal time-weighted average (TWA) air
concentrations of diacetyl in several job locations of the six
investigated plants (Kanwal et al., 2006). The average full shift air
levels of diacetyl in the mixing areas and production locations in
close proximity to mixing tanks ranged from 0.2 to 38 ppm.\2\ By
contrast, average diacetyl concentrations were 0.03 ppm or less in the
packaging areas that were isolated from the mixing tanks. Several task-
based measurements at one plant showed that diacetyl concentrations
averaged 5 to 10 ppm for 30 to 60 minutes following the open transfer
of
[[Page 3941]]
butter flavoring to heated mixing tanks (NIOSH, 2003a).
---------------------------------------------------------------------------
\2\ NIOSH subsequently determined that the diacetyl sampling
method used in its investigations of microwave popcorn and flavor
manufacturing facilities can be affected by relative humidity and
that high humidity levels may result in an underestimation of true
airborne diacetyl concentrations (NIOSH, 2003b). NOISH is working to
develop a set of correction factors and to validate a new method for
the measurement of diacetyl in the workplace.
---------------------------------------------------------------------------
Investigations of Plants That Manufacture Food Flavors That Contain
Diacetyl
Cases of airway obstruction have also been reported and
investigated in food flavor manufacturing facilities. NIOSH described
severe fixed airway obstruction compatible with bronchiolitis
obliterans in two former employees of a company that blended large
batches of flavoring ingredients with corn starch and flour to make
``cinnabutter'' and other flavors for use in the baking industry
(NIOSH, 1986). Researchers at the University of Cincinnati College of
Medicine reported severe respiratory disease with clinical findings
consistent with bronchiolitis obliterans in five employees at a large
flavor manufacturing facility (Lockey et al., 2002). The State of
California began an active investigation of obstructive airway disease
at flavoring manufacturing establishments in the State after learning
of two employees with confirmed bronchiolitis obliterans at separate
Southern California plants (CDC, 2007). By January 2007, the State
identified six additional employees with suspected fixed obstructive
lung disease at three additional flavor manufacturing establishments
(Materna, 2007). The eight individuals were flavoring compounders and
their jobs involved mixing chemicals, including diacetyl, to make food
flavorings.
Recently, NIOSH conducted health hazard evaluations at two Southern
California flavor manufacturing plants (NIOSH, 2007a; 2007b) where four
current or former employees who worked in powder production and handled
diacetyl or diacetyl-containing flavors had severe fixed airway
obstruction. Personal air sampling completed at one plant found mean
full-shift TWA diacetyl air levels of 0.22 ppm (range: 0.002 ppm to 1.1
ppm) and mean process-associated diacetyl air levels of 7.7 to 21 ppm
over one to two hour productions of diacetyl-containing butter-flavored
and vanilla-flavored powders.\2 \
A study by the National Jewish Medical and Research Center (NJMRC)
found that production employees from eleven flavoring manufacturing
sites reported higher than expected rates of respiratory symptoms and
asthma (Rose, 2007). The study also found that employees with the
highest cumulative exposures to diacetyl were more likely to experience
process-related breathing problems and eye, nose, and throat irritation
than employees with the lowest cumulative exposures. The highest
diacetyl air levels were measured during the production of powder and
liquid formulations using the NIOSH sampling method \2\ (Martyny et
al., 2008).
Workplace air levels of diacetyl in powder production areas of
monitored plants as well as the type of respiratory problems
experienced by the employees were similar to those found in the mixing
areas of microwave popcorn plants. However, one important distinction
is that employees who work in mixing operations at microwave popcorn
plants are typically exposed to butter flavorings on a daily basis
while flavoring compounders are usually exposed less frequently at some
flavor manufacturing facilities. Thus, based on currently available
information, it is not clear whether the risk of airway obstruction
among blenders working at food flavoring manufacturing would be similar
to mixers in microwave popcorn production.
Investigation at a Diacetyl Production Plant
Four cases of obstructive airway disease compatible with
bronchiolitis obliterans were found among diacetyl process operators
who worked at a Dutch chemical plant that produced diacetyl (Van Rooy
et al., 2007). These workers were regularly exposed to diacetyl and a
limited number of other agents, as opposed to the much larger number of
compounds present during flavor manufacture or use of butter flavoring
in microwave popcorn production. In addition to diacetyl, acetoin was
manufactured as a co-product during the diacetyl production process.
Acetaldehyde and acetic acid were also formed as side products during
the process. The employees in the study reported a greater prevalence
of certain respiratory symptoms, such as trouble breathing, chronic
cough, and physician-diagnosed asthma than the general Dutch population
when adjusted for age and smoking habits (Van Rooy et al., 2008).
Inhalation Studies in Experimental Animals
NIOSH examined the effects of liquid butter flavoring vapors (BFV)
and pure diacetyl on the respiratory tract of Sprague Dawley rats
exposed to a one-time six hour inhalation study (Hubbs et al., 2002;
2008). Rats exposed to diacetyl above 200 ppm either as pure vapor or
as a mixture with other butter flavoring compounds suffered dose-
dependant inflammation and necrosis of the epithelium extending from
the nose into the bronchii. The epithelial injury in rats exposed to
pure diacetyl covered a less extensive area of the respiratory tract
than BFV-exposed animals receiving similar diacetyl concentrations.
This suggests that other butter flavoring components in addition to
diacetyl may contribute to the flavoring-induced airway damage. There
also was no difference in respiratory damage whether the total diacetyl
dose was administered continuously over six hours or in four 15 minute
pulses. There were no significant pathological changes in bronchiolar
epithelium or alveoli at any diacetyl concentration.
A National Institute of Environmental Health Sciences (NIEHS) study
found respiratory effects in mice exposed to pure diacetyl. NIEHS
evaluated the respiratory tract toxicity in C57BL/6 mice exposed to
repeated inhalations of pure diacetyl for up to twelve weeks (Morgan et
al., 2008). Mice exposed to 50 ppm and 100 ppm dose levels were found
to have dose-dependant mild to moderate nasal tissue necrosis. A
lymphocytic bronchitis extending into the lower airways was found in
the mice exposed to 100 ppm. In an effort to bypass the extensive
removal of water-soluble diacetyl vapors that occurs in the nasal
passages of mice, liquid diacetyl was forced deep into the lung by
oropharyngeal aspiration. This caused fibrotic focii in the terminal
bronchioles and alveolar ducts. Although these lesions were not
identical to bronchiolitis obliterans, there was sufficient similarity
to suspect that they may progress to bronchiolitis with continued
exposure. The National Toxicology Program has approved the nomination
of BFV, diacetyl, and acetoin for longer term inhalation testing.
II. Request for Data, Information, and Comment
OSHA is seeking data, information, and comment on a variety of
topics relevant to the Agency's development of a proposed rule
addressing occupational exposure to diacetyl and food flavorings
containing diacetyl. The questions below highlight specific areas of
concern to OSHA. When answering specific numbered questions below,
please key your responses to the number of the question, explain the
reasons supporting your views, and identify and provide relevant
information on which you rely, including any studies or articles that
support your comments. In addition to the questions presented below,
respondents are encouraged to address any aspect of occupational
exposure to diacetyl and food flavorings containing diacetyl that they
feel is pertinent.
[[Page 3942]]
When requesting information, OSHA refers to ``diacetyl and food
flavorings containing diacetyl.'' In addition to food flavorings, OSHA
intends the term to encompass diacetyl present in substances other than
food flavorings (e.g., naturally occurring diacetyl or diacetyl in
fragrances), as well as other constituents of food flavorings
containing diacetyl. ``Starter distillate,'' also referred to as
``butter starter distillate,'' should be considered a form of diacetyl.
As discussed previously, butter flavorings are complex and variable
mixtures, containing a number of respiratory irritants and potential
airway reactive substances. In addition to information on diacetyl,
OSHA seeks information on acetoin, acetaldehyde, acetic acid, furfural,
and other compounds present in food flavorings that may cause or
contribute to flavoring-related lung disease. The Agency is also
interested in information on substitutes used in place of diacetyl
(e.g., diacetyl trimer).
A. Production and Uses
Diacetyl and food flavorings containing diacetyl are used in a wide
variety of industries and processes, and employee exposure to these
substances occurs in many different occupational settings. Exposures
have been recorded in various operations in the microwave popcorn and
the flavor manufacturing industries. Exposures are also likely in a
wide range of food processing and food service industries where
diacetyl and food flavorings containing diacetyl are used and in other
industries where diacetyl is volatilized (e.g., fragrance-related
exposures). OSHA would appreciate detailed responses to these questions
concerning the production and use of diacetyl and food flavorings
containing diacetyl.
1. What is your primary line of business? Please indicate the types
of products or services your firm produces or provides, the number of
establishments you have, and how many full-time and part-time employees
work at each establishment.
2. Does your firm or any other U.S. firm produce diacetyl? If so,
indicate the form of diacetyl (e.g., powder, liquid, encapsulated) and
the quantity produced, how frequently it is produced, and the
circumstances in which it is produced.
3. Does your firm use diacetyl? If so, indicate the form of
diacetyl (e.g., powder, liquid, encapsulated) and quantity used, the
purpose(s) it is used for, how frequently it is used, and the
circumstances in which it is used. OSHA is particularly interested in
the extent of diacetyl use as a preservative. Does your firm use
diacetyl for that purpose? If so, please describe the nature of the
use, the total volume of diacetyl used and potential employee exposure.
4. Does your firm use any natural or artificial flavorings that
might contain diacetyl, such as dairy (e.g., butter, cheese, sour
cream, yogurt), ``brown'' (e.g., caramel, butterscotch, brown sugar,
maple, coffee flavors), fruit, marshmallow, or egg flavorings? If so,
please indicate which flavorings you use, the quantity you use, and the
purpose(s) for their use. If any of these flavorings are known to
contain diacetyl, please indicate which flavorings contain diacetyl and
the percentage of diacetyl, by weight, they contain.
5. Does your firm heat margarine or use butter-flavored cooking
oils or cooking sprays? If so, please indicate the quantity of these
substances you use and the purpose(s) for their use. If any of these
substances are known to contain diacetyl, please indicate which
substances contain diacetyl and the percentage of diacetyl, by weight,
they contain.
6. Does your firm use, add, or handle flavorings or food products
that contain naturally occurring diacetyl, such as dairy products, wine
or beer? Please describe the circumstances in which you use, add, or
handle naturally occurring diacetyl.
7. Does your firm manufacture or use fragrances? If so, do any of
these fragrances contain diacetyl? Please indicate which fragrances
contain diacetyl, how much diacetyl they contain, how the fragrances
are used, and the quantities produced or used.
B. Employee Exposure
8. What are the job categories and operations in which employees
are potentially exposed to diacetyl or food flavorings containing
diacetyl in your company or industry? For each job category or
operation, please provide a description of how the exposure takes
place. OSHA is particularly interested in any operations that involve
manual tasks; operations that involve products being sprayed,
sprinkled, or coated with flavorings or ingredients containing
diacetyl; operations that involve heating of ingredients; and tasks in
laboratories for product testing or research and development that
involve handling of diacetyl or food flavorings containing diacetyl.
9. How many employees are exposed to diacetyl or food flavorings
containing diacetyl, or have the potential for exposure, in each job
category or operation in your company or industry?
10. What are the frequency, duration, and levels of employee
exposures to diacetyl in each job category in your company or industry?
Please indicate the engineering or other controls in place when
exposures were measured, as well as the analytical method and type of
samples used for determining exposure levels. If possible, OSHA
requests that you provide personal exposure sampling data with clear
descriptions of the length of time the samples were collected. If
personal sampling data are not available, OSHA requests any exposure
data you provide indicate the form and length of the exposure. If
sampling was performed using NIOSH Method 2557, please indicate the
flow rate used and the temperature and relative humidity at the time
sampling was performed, if possible.
11. How many years do employees potentially exposed to diacetyl or
food flavorings containing diacetyl remain in their jobs? Do employees
who leave such positions typically move to new jobs that do not involve
exposure, or are they likely to transfer to jobs that involve potential
exposure to diacetyl or food flavorings containing diacetyl?
C. Health Effects
The Background section discusses several studies that report an
increased occurrence of airway obstruction, bronchiolitis obliterans,
and other respiratory disorders among employees in jobs involving
exposure to diacetyl and food flavorings containing diacetyl. Diacetyl
and other potential airway reactive compounds (e.g., acetoin,
acetaldehyde, acetic acid, furfural) present in food flavorings may
contribute to the observed respiratory effects. The Agency is seeking
additional studies, articles, data, and information that OSHA can use
to evaluate health effects related to occupational exposure to these
substances. The Agency specifically requests the following:
12. Describe and provide any additional case reports,
epidemiological and animal studies, and data not mentioned in this
notice that OSHA should consider in evaluating the potential health
risks associated with exposure to diacetyl and food flavorings
containing diacetyl. If available, please include associated short-
term, task-oriented, and full-shift time weighted average exposure data
and indicate the method of sampling and analysis used. If sampling was
performed using NIOSH Method 2557, please indicate the flow rate used
and the temperature and
[[Page 3943]]
relative humidity at the time sampling was performed. Describe and
provide any studies and data that report changes in the occurrence of
flavoring-related health risks from implementing exposure controls and
work practices.
13. Describe and provide any available reports and data, not
mentioned in this notice, on employees experiencing respiratory
symptoms, pulmonary function abnormalities, clinical evidence of
respiratory disease, or other adverse health outcomes associated with
exposure to diacetyl or food flavorings containing diacetyl at your
establishment or other establishments where these substances are
manufactured or used. Please include information on the nature of the
use, processes, job tasks, and exposures.
14. Describe any ongoing efforts to collect information and data
that would assist in the identification of adverse health effects
associated with diacetyl and food flavorings containing diacetyl.
Please provide any currently available reporting information,
anticipated date of completion and when the completed research report
and/or data collection could be made available to OSHA for the
development of a proposed rule.
15. Occupational investigations have reported respiratory symptoms
and spirometry abnormalities, particularly reduced FEV1 and
FEV1/FVC, among employees in jobs involving exposure to
diacetyl and food flavorings containing diacetyl. What respiratory
symptomatology and declines in these spirometry test values should OSHA
consider to be indicative of flavoring-related respiratory disease?
Please identify the prevalence of symptoms and other clinical findings
associated with various levels of reduction in FEV1 and
FEV1/FVC. Please cite your sources.
16. Where longitudinal information is available, please describe
any progression of symptoms, pulmonary function test results, and other
clinical findings or abnormalities that may have preceded cases of
bronchiolitis obliterans.
17. Is there any evidence that other potential airway-reactive
flavoring compounds, such as those mentioned in the lead paragraph of
this section, contribute to flavoring-related respiratory disease? Are
there structure activity data that may be useful for predicting
compounds likely to cause airway damage? Please explain and provide
supporting data.
18. Describe and provide any studies and data related to
respiratory tract absorption, clearance, and metabolism of diacetyl or
other flavoring agents that may be likely to contribute to flavoring-
related respiratory disease. Describe and provide studies and data
pertinent to understanding the mechanism of action by which these
compounds may cause adverse respiratory system effects.
19. Research studies report that diacetyl preferentially damages
the lining of the nose and upper respiratory tract when inhaled by rats
and mice. Should OSHA consider the upper airway damage in experimental
animals exposed to diacetyl or butter flavoring vapors as clinically
relevant to the respiratory disease that occurs in the lower airways of
employees exposed to food flavorings containing diacetyl? Please
explain. Are there other examples of toxic agents that damage the nose
and upper airways when inhaled by rodents but cause primarily lower
airway disease in humans? Please support your response with specific
examples and studies.
D. Risk Assessment
OSHA is interested in data that will assist the Agency in
developing quantitative estimates of any occupational risk of airway
obstruction, fixed airways obstruction, bronchiolitis obliterans, and
any other relevant biological endpoints from exposures to diacetyl and
food flavorings containing diacetyl.
20. What biological endpoints should OSHA consider to estimate the
occupational risk to employees exposed to diacetyl or food flavorings
containing diacetyl? Are there endpoints other than airway obstruction,
fixed airway obstruction, and bronchiolitis obliterans that OSHA should
consider? Please explain.
21. What studies or data should be used to derive a quantitative
estimate of the risk resulting from exposure to diacetyl or food
flavorings containing diacetyl? OSHA seeks studies, scientific
information, and data regarding frequency, intensity, duration, and
other parameters of worker exposure in the affected industries,
occupations, and activities; key default factors and assumptions; and
other relevant information related to the potential development of a
health standard regulating diacetyl and food flavorings containing
diacetyl.
22. In its risk assessment, how should the Agency treat cross-
sectional data describing the prevalence of airway obstruction? Please
describe the relationship that might be expected, in an occupational
setting, between the prevalence and incidence of airway obstruction.
23. In studies investigating employees exposed to diacetyl or food
flavorings containing diacetyl, what proportion, if any, of employees
who experienced airway obstruction in those studies might be expected
to develop bronchiolitis obliterans? Please explain your reasoning.
24. When developing dose-response assessments from animal studies,
what adjustments and/or scaling factors should OSHA consider to account
for species differences between animals and humans in the dose
delivered to the lower respiratory tract? Are there toxicokinetic
models that can assist in these interspecies extrapolations? Please
explain.
25. Some of the job categories associated with higher-than-expected
prevalences of airway obstruction involved tasks that generated very
high short-term peak exposures to food flavorings containing diacetyl.
What role may short-term and cumulative exposures to diacetyl or food
flavorings containing diacetyl play in causing health effects and how
should OSHA account for this in the risk assessment?
26. What exposure metric(s) (e.g., cumulative exposure, duration of
exposure, and short-term task-based exposure) should OSHA consider in
assessing the risk associated with exposure to diacetyl or food
flavorings containing diacetyl? Are means, geometric means, or medians
preferable as measures of central tendency of group exposure data?
27. What statistical methods, models, and data should OSHA consider
for estimating the risk from exposure to diacetyl and food flavorings
containing diacetyl?
28. What job classifications, tasks, or operations involving
diacetyl or food flavorings containing diacetyl may be associated with
an elevated occurrence of adverse health effects? For example, some
studies have reported higher-than-expected prevalences of airway
obstruction in employees performing mixing and quality control tasks.
29. Please describe and provide any studies or data you believe the
Agency should consider regarding dose-response behavior and mode of
action of diacetyl including physiochemical, metabolic, cellular,
mechanistic, and dosimetric considerations. For instance, are adverse
health effects dependent on the dose rate and intensity over the
exposure period rather than the total cumulative dose received? Please
explain. Do the data and mode of action suggest a threshold effect?
Please explain.
30. Does the form of diacetyl (e.g., liquid vs. powdered) affect
dose-response behavior? For example, does the form of diacetyl affect
its respiratory deposition? If so, please explain.
[[Page 3944]]
31. Are there any existing risk assessments addressing diacetyl or
food flavorings containing diacetyl that OSHA should consider? Please
identify and provide.
E. Exposure Assessment and Monitoring Methods
32. Do you conduct exposure monitoring for diacetyl or other
chemicals (e.g., acetoin, acetaldehyde, acetic acid, furfural) found in
food flavorings? If so, please indicate the chemical(s) sampled for;
the method(s) of sampling and analysis used; the type of samples
collected (i.e., personal or area samples); the job categories, tasks,
operations, or areas where sampling is performed; the duration of
sampling (e.g., 8-hour time-weighted average, 15 minute peak); and the
frequency of sampling.
33. What type of sampling methods are available for measuring
diacetyl in the workplace when it is encapsulated within a powder
matrix or adsorbed onto a powder surface? Please provide information on
any sampling and analytical methods applicable for determining exposure
to diacetyl-containing powders based on total, respirable, thoracic, or
inhalable size fractions. Are there any methods under development or
any laboratory methods used by food flavorists or food chemists that
could potentially be applied? Please provide any information available
on the precision and accuracy of the sampling method, the range and
limits of detection, and the method of validation of sampling and
analysis. Please also provide methods for analysis of diacetyl in bulk
process materials.
34. If sampling is conducted by in-house staff to evaluate employee
exposure to diacetyl and food flavorings containing diacetyl, please
indicate the number of hours required to collect the samples and costs
for laboratory analysis. If you engage an outside party to perform
sampling and analysis, please indicate the costs incurred.
F. Control Measures
35. To what extent have you or other users reduced or eliminated
use of diacetyl or food flavorings containing diacetyl? Please explain
how you have achieved those reductions. What substitutes are used for
diacetyl? What types of flavorings have been most affected by reduction
or elimination of diacetyl use? What types of flavorings are most
suitable for change and what types are most difficult to produce
without diacetyl? What factors have been responsible for changes in
diacetyl use (e.g., employee health concerns, consumer demand)? If you
have not reduced or eliminated the use of diacetyl, what were your
reasons for not substituting at this time? OSHA requests that
commenters indicate why substitutes for diacetyl have or have not been
used, and describe any technological, economic or other barriers or
hindrances to substitution. OSHA also requests measurements of employee
exposure to substances used as substitutes for diacetyl, and any
measurements of employee exposure to diacetyl after substitution,
particularly for substitutes which may convert to diacetyl.
36. Have you installed engineering controls or adopted work
practices to reduce exposures to diacetyl and food flavorings
containing diacetyl? If so, please indicate the types of controls
implemented and the operations, tasks, or processes where they have
been applied. Please describe whether and to what extent these controls
have reduced employee exposure. Please indicate any operations or
processes in your facility for which engineering controls are not
available or have not been applied. Please explain what difficulties
you have encountered in applying engineering controls in those
operations.
37. Does your firm limit access to areas where diacetyl or food
flavorings containing diacetyl are present in order to control employee
exposures to these substances? Please describe the basis for
establishing these areas (e.g., operations, exposure levels), methods
used to demarcate and control access to the areas, and any obstacles to
implementation.
38. Do you provide respirators or other types of personal
protective equipment (e.g., gloves) to employees exposed to diacetyl or
food flavorings containing diacetyl? If so, describe your program and
identify the type of equipment provided, the basis for selection, and
any difficulties encountered in implementing your program.
39. Describe the conditions in which respirators and other personal
protective equipment are used, including any criteria (e.g., regulated
area, exposure level, type of operation, duration of exposure) you use
for triggering their use. Are there any processes or areas where it is
not possible to use respirators or other protective equipment? Please
explain.
G. Employee Training
40. What information and training do you provide to your employees
about occupational exposure to diacetyl and food flavorings containing
diacetyl? Please describe your training program, including job
categories included in the program, criteria for determining which
employees receive information and training, program content, methods of
providing information and training, length of training, frequency, and
any procedures used to address language or literacy barriers.
41. How do you determine the effectiveness of training? Describe
methods used and any factors taken into account in examining the
effectiveness of training programs.
H. Medical Surveillance Programs
OSHA is interested in medical surveillance programs that employers
use or recommend to identify and monitor employees who exhibit signs,
symptoms, or other clinical findings associated with occupational
exposure to diacetyl and food flavorings containing diacetyl.
42. Do you have a medical surveillance program to identify or
prevent health effects associated with exposure to diacetyl and food
flavorings containing diacetyl (this could include a general medical
surveillance program that would cover exposure to other chemicals)?
Please describe your program. What tests, procedures, examinations, and
questions does your program include and at what frequency? Please
provide any protocols and standards of care. What are the
qualifications and credentials of the health professionals supervising
and administering the surveillance program?
43. What criteria (e.g., job categories, duties, exposure levels)
do you use or recommend to determine when to provide medical screening
or surveillance?
44. What signs, symptoms, test results, or illnesses have been
detected or reported that you believe may be related to exposure to
diacetyl or food flavorings containing diacetyl? What jobs, tasks, and
operations did affected employees perform? What levels of diacetyl were
affected employees exposed to (including 8-hour time-weighted averages
during an 8-hour work shift and during specific tasks, 15 minute peaks,
cumulative exposure, and the duration of exposure, if available)?
45. Have any of your employees been diagnosed with bronchiolitis
obliterans? If so, please describe any pulmonary function abnormalities
or other clinical signs or symptoms that preceded the diagnosis.
46. If your medical surveillance program includes pulmonary
function testing, please describe any cross-sectional findings or
longitudinal trends that you have observed. Specifically, what
correlations, if any, have you
[[Page 3945]]
observed between pulmonary function test results and exposure to
diacetyl or food flavorings containing diacetyl (including associations
with peak exposures, cumulative exposure, duration of exposure, or
particular job classifications, tasks, or operations)? Please describe
whether and how findings or trends have varied depending on the form of
diacetyl to which employees have been exposed (e.g., powdered vs.
liquid formulation).
47. Have you ever removed employees from a job because of adverse
health effects attributed to exposure to diacetyl or food flavorings
containing diacetyl? If so, please describe the circumstances of the
removal, what jobs they were moved into, and potential return. For how
long were these employees generally removed? Have any employees ever
been permanently removed from a job because of such adverse health
effects?
48. Have medical screening and surveillance had any effect on the
number and severity of adverse health effects detected or reported?
49. Please describe the costs of medical surveillance for employees
exposed to diacetyl and food flavorings containing diacetyl. Where
possible, please indicate the number of hours per year the average
employee spends on activities related to medical surveillance or
screening and how many of those hours are spent traveling to see health
care providers. If you employ a health care provider to administer
medical surveillance programs, please indicate the number of hours the
health care provider spends each year on screening, surveillance and
management of employees exposed to diacetyl or food flavorings
containing diacetyl. If you do not employ a health care provider to
administer medical programs, please indicate the costs per employee for
surveillance or screening for adverse health effects associated with
diacetyl or food flavorings containing diacetyl. Also, please describe
the cost of any equipment or supplies that you have purchased for use
in medical programs associated with exposure to diacetyl or food
flavorings containing diacetyl.
I. Environmental Impacts
The National Environmental Policy Act (NEPA) of 1969 (42 U.S.C.
4321, et seq.), the Council on Environmental Quality (CEQ) regulations
(40 CFR part 1500), and the Department of Labor (DOL) NEPA Compliance
Regulations (29 CFR part 11), require that OSHA give appropriate
consideration to environmental issues and the impacts of proposed
actions that significantly affect the quality of the human environment.
OSHA is currently collecting written information and data on possible
environmental impacts that could occur outside of the workplace (e.g.,
exposure to the community through contaminated air/water, contaminated
waste sites) if the Agency were to promulgate a standard for
occupational exposure to diacetyl and food flavorings containing
diacetyl. Such information should include both negative and positive
environmental effects that could be expected to result from a revised
standard on occupational exposure to diacetyl or food flavorings
containing diacetyl. Specifically, OSHA requests comments and
information on the following:
50. What is the potential direct or indirect environmental impact
(for example, the effect on air and water quality, energy usage, solid
waste disposal, and land use) that might result from a reduction in
employee exposure to diacetyl or food flavorings containing diacetyl or
the use of substitutes for diacetyl or food flavorings containing
diacetyl?
51. Are there any situations in which reducing exposures of
diacetyl or food flavorings containing diacetyl to employees would be
inconsistent with meeting environmental regulations? (Note: In
estimates of control costs, OSHA will account for any costs of meeting
air quality requirements associated with increased ventilation
controls. The issue here is whether there are situations in which
ventilation and other controls would be incompatible with air pollution
controls.)
J. Economic Impacts
52. What do you estimate would be the expected costs of a standard
to control occupational exposure to diacetyl and food flavorings
containing diacetyl? What do you estimate would be the costs for
enhanced ventilation controls in your establishments? What do you
estimate would be the costs of providing exposure assessments, medical
surveillance and training? Please explain how you derived your cost
estimates.
53. What are the potential economic impacts associated with a
standard to control occupational exposure to diacetyl and food
flavorings containing diacetyl? Will the expected costs have a severe
impact on your firm or your industry? Please explain. Please indicate
what industry segment you represent. Do you anticipate any difficulties
in providing exposure assessments, medical surveillance, or training?
Please explain.
54. Are there foreign sources of food flavorings containing
diacetyl? What are those sources?
55. In response to a standard on occupational exposure to diacetyl
or food flavorings containing diacetyl, will firms stop manufacturing
or using food flavorings containing diacetyl, or will they implement
controls to reduce potential exposures? Can you estimate the share of
flavoring manufacturers that will eliminate food flavorings containing
diacetyl and the share that will continue to manufacture them? What
substances are available now, or might be available in the future, as
substitutes for diacetyl or food flavorings containing diacetyl? What
would be the costs and economic impacts associated with substituting
other flavoring ingredients for diacetyl?
K. Impacts on Small Entities
The Regulatory Flexibility Act requires that OSHA assess the impact
of proposed and final rules on small entities (5 U.S.C. 601 et seq.).
OSHA requests that members of the small business community and others
familiar with small business concerns address any special circumstances
small entities might face in controlling occupational exposure to
diacetyl and food flavorings containing diacetyl. OSHA has already
determined that this regulatory action will require a preliminary
regulatory flexibility analysis, and thus a Small Business Regulatory
Enforcement Fairness Act panel (5 U.S.C. 609(b)).
56. How many and what kinds of small entities perform operations
using diacetyl or food flavorings containing diacetyl? What percentage
of the affected industries do they comprise?
57. How and to what extent would small entities in your industry be
affected by the promulgation of a standard that addresses occupational
exposure to diacetyl and food flavorings containing diacetyl? Are there
special circumstances that make the control of occupational exposure to
diacetyl and food flavorings containing diacetyl more difficult or more
costly in small entities? Describe those circumstances.
58. The most important goal of the regulatory flexibility analysis
is to find and consider alternatives that may serve to meet the goals
of OSHA while alleviating burden on affected small entities. Please
suggest and discuss any alternatives that might serve to minimize these
impacts.
L. Duplication/Overlapping/Conflicting Rules
59. Are there any Federal rules that might duplicate, overlap, or
conflict with any standard that OSHA may promulgate on diacetyl or food
flavorings containing diacetyl? If so, please identify which ones and
explain
[[Page 3946]]
how they would duplicate, overlap, or conflict.
60. Are there any Federal programs in areas such as defense or
energy that might be impacted by any standard that OSHA may promulgate
on diacetyl or food flavorings containing diacetyl? If so, please
identify which ones and explain how they would be impacted.
M. Approaches to Regulation
Most OSHA health standards apply when there is occupational
exposure to the substance being regulated. Although OSHA is aware of
possible occupational exposures to diacetyl that do not involve food
flavorings, the known cases of occupational lung disease are associated
with employees exposed to food flavorings containing diacetyl. Employee
exposures to diacetyl may occur during processing of foods in which
diacetyl occurs naturally, such as dairy products, wine, and beer; when
using flavored oils or butter for cooking purposes; when making
fragrances; and when adding fragrances to products. Should OSHA cover
all occupational exposures to diacetyl under a proposed standard, or
should the standard focus on certain industries, processes, or
applications? Which sectors should OSHA consider covering under a
proposed rule?
61. Acetoin is a plausible contributor to flavoring-related lung
disease, given its volatility, structural similarity to diacetyl, and
presence in all of the work environments in which elevated prevalence
of respiratory disease has been noted. In addition to diacetyl, should
OSHA cover occupational exposures to acetoin under a proposed standard?
Please indicate the basis for your position and include any supporting
evidence.
62. Should OSHA exclude chemical mixtures containing diacetyl at
concentrations below a certain threshold from coverage under a proposed
standard? If so, what threshold (i.e., percent content) should OSHA
consider? Please indicate the basis for your position and include any
supporting evidence.
63. Should OSHA propose a permissible exposure limit (PEL) for
diacetyl or, instead, should the Agency propose process-specific
requirements for engineering controls, exposure monitoring, exposure
control planning, and respiratory protection (i.e., a non-PEL
approach)? Although a PEL approach would be consistent with the
majority of the Agency's previous standards that regulate chemical
hazards, OSHA typically relies on specified engineering and work
practice controls in regulating safety hazards, so such an approach
would not be novel. OSHA welcomes comments on the merits of the two
approaches as well as any other approaches to addressing occupational
exposure to diacetyl and food flavorings containing diacetyl.
64. What provisions should OSHA include in a proposed standard
addressing occupational exposure to diacetyl and food flavorings
containing diacetyl? OSHA substance-specific health standards typically
include provisions for exposure monitoring, regulated areas, methods of
compliance, respiratory protection, protective clothing and equipment,
medical surveillance, and training, as well as other requirements.
Please indicate what provisions would or would not be appropriate for
protecting employees from exposure to diacetyl and food flavorings
containing diacetyl, and explain the reasons for your position.
65. The California Division of Occupational Safety and Health (Cal/
OSHA) has initiated rulemaking proceedings on diacetyl and other food
flavorings. In March 2007, Cal/OSHA released a draft regulatory text
titled ``Occupational Exposure to Food Flavorings'' (Cal/OSHA, 2007).
The draft regulatory text includes requirements for exposure
assessment, engineering and work practice controls, respiratory
protection, medical surveillance, training and labeling, and
recordkeeping, but does not establish a PEL. Are there any provisions
in the draft that OSHA should include in a proposed rule on
occupational exposure to diacetyl or food flavorings containing
diacetyl? Are there any aspects of the draft that you consider
inappropriate? Please explain.
66. NIOSH has issued an alert entitled ``Preventing Lung Disease in
Workers Who Use or Make Flavorings'' as well as recommendations for
minimizing employee exposures to flavorings and flavoring ingredients
(NIOSH, 2003). Are there any provisions or recommendations in those
documents that OSHA should include in a proposed rule on occupational
exposure to diacetyl or food flavorings containing diacetyl? Do you
consider any of the provisions or recommendations inappropriate? Please
explain.
III. Public Participation
You may submit comments in response to this document (1)
Electronically at http://www.regulations.gov, (2) by hard copy, or (3)
by facsimile (FAX). All comments, attachments, and other materials must
identify the Agency name and the docket number for this document
(Docket No. OSHA-2008-0046). You may supplement electronic submissions
by uploading document files electronically. If, instead, you wish to
mail additional materials in reference to an electronic or FAX
submission, you must submit three copies to the OSHA Docket Office (see
ADDRESSES section). The additional materials must clearly identify your
electronic or FAX comments by name, date, and docket number so OSHA can
attach them to your comments.
Because of security-related problems there may be a significant
delay in the receipt of comments by regular mail. For information about
security procedures concerning the delivery of materials by express
delivery, hand delivery, and messenger or courier service, please
contact the OSHA Docket Office at 202-693-2350 (TTY 877-889-5627).
All comments and submissions in response to this Federal Register,
including personal information, are placed in the public docket without
change. Therefore, OSHA cautions against submitting certain personal
information such as social security numbers and birthdates. All
comments and submissions are listed in the http://www.regulations.gov
index; however, some information (for example, copyrighted material) is
not publicly available to read or download through the Web site. All
comments, submissions, and supporting materials are available for
inspection and copying at the OSHA Docket Office (see the ADDRESSES
section of this notice). Information on using http://www.regulations.gov to submit comments and access dockets is available
at that Web site. Contact the OSHA Docket Office (see ADDRESSES
section) for information about materials not available through the OSHA
Web site and for assistance in using the Web site to locate and
download docket submissions.
Electronic copies of this Federal Register notice are available at
http://www.regulations.gov. This document, as well as news releases and
other relevant documents, are also available at OSHA's Web site at
http://www.osha.gov.
IV. References
Akpinar-Elci M, Travis WD, Lynch DA, Kreiss K. 2004. Bronchiolitis
Obliterans Syndrome in Popcorn Production Plant Workers, Eur Respir
J. 2004; 24:298-302.
Bibek R. 2004. Fundamental Food Microbiology, CRC Press, pp. 228 and
608.
Cal/OSHA. 2007. Occupational Exposure to Food Flavorings (Draft
Regulatory Text). California Department of Industrial Relations,
Division of Occupational Safety and Health.
[[Page 3947]]
CDC. 2007. Fixed Obstructive Lung Disease Among Workers in the
Flavor-Manufacturing Industry--California, 2004-2007, Centers for
Disease Control and Prevention, Morbidity and Mortality Weekly
Report. 56(16):389-393.
ConAgra Foods. 2007. News Release: ConAgra Foods Introduces Orville
Redenbacher's[supreg] and Act II[supreg] Microwave Popcorn with a
New Great Tasting Butter Flavoring with No Added Diacetyl. ConAgra
Foods, Inc.
ERG. 2007. Support for the Development of Economic Profile Data of
Diacetyl-Using Industries (Microwave Popcorn and Flavoring). Eastern
Research Group, Inc. Interim Final Report: Task Order No. 12,
Contract No. GS-10F-0125P.
Egilman D, Mailloux C, Valentin C. 2007. Popcorn-worker Lung Caused
by Corporate and Regulatory Negligence: An Avoidable Tragedy,
Intern. J. Occupational Environ. Health 13:85-98.
FEMA. 2005. Flavor and Extract Manufacturers Association. Poundage
and Technical Effects Update Survey, p. 61.
Hubbs AF, Battelli LA, Goldsmith WT, Porter DW, Frazer D, Friend S,
Schwegler-Berry D, Mercer RR, Reynolds JS, Grote A, Castranova V,
Kullman G, Fedan JS, Dowdy J, Jones WG. 2002. Necrosis of nasal and
airway epithelium in rats inhaling vapors of artificial butter
flavoring. Toxicol Appl Pharmacol 185(2):128-35.
Hubbs AF, Goldsmith W, Kashon M, Frazer D. 2008. Respiratory
Toxicologic Pathology of Inhaled Diacetyl in Sprague-Dawley Rats,
Toxicol. Pathol. 36(2):330-344.
Kanwal R. 2008. Bronchiolitis Obliterans in Workers Exposed to
Flavoring Chemicals, Curr. Opin. In Pulmon. 14:141-146.
Kanwal R, Kullman G, Piacitelli C, Boylstein R, Sahakian N, Martin
S, Fedan K, Kreiss K. 2006. Evaluation of Flavorings-Related Lung
Disease Risk at Six Microwave Popcorn Plants, JOEM 48(2):149-157.
Kreiss K, Gomaa A, Kullman G, Fedan K, Simoes EJ, Enright PL. 2002.
Clinical Bronchiolitis Obliterans in Workers at a Microwave-Popcorn
Plant, New England J. of Med. 347(5):330-338.
Lockey J, McKay R, Barth E, Dahlsten J, Baughman R. 2002.
Bronchiolitis Obliterans In The Food Flavoring Manufacturing
Industry. Meeting of the American Thoracic Society.
Lone Star Candle Supply. 2003. Material Safety Data Sheet for
Marshmallow Madness Fragrance Oil.
Martyny JW, Van Dyke M, Arbuckle S, Towle M, Rose CS. 2008. Diacetyl
Exposure in the Flavoring Industry. Journal of Occupational and
Environmental Hygiene 5:679-688.
Materna B. 2007. Summary of eight known cases of confirmed or
obstructive lung disease in California food flavor manufacturing
workers. January 11, 2007.
Morgan D, Flake GP, Kirby PJ, Palmer SM. 2008. Respiratory Toxicity
of Diacetyl in C57BL/6 Mice, Toxicol. Sci. 105(2):429-32.
NIOSH. 1986. Health Hazard Evaluation Report. HETA-85-171-1710:
International Bakers Services, Inc., South Bend, Indiana.
NIOSH Alert. 2003a. Preventing Lung Disease in Workers Who Use or
Make Flavoring. DHHS Publication Number 2004-110.
NIOSH 2003b. NIOSH Manual of Analytical Methods. Diacetyl: Method
2557 Issue 1:15 March.
NIOSH. 2007a. Health Hazard Evaluation Report. HETA-2007-0033: Gold
Coast Ingredients, Inc., Commerce, California. Interim Report.
NIOSH. 2007b. Health Hazard Evaluation Report. HETA 2006-0303-3043:
Report on Severe Fixed Obstructive Lung Disease in Workers at a
Flavoring Manufacturing Plant. Carmi Flavor and Fragrance Company,
Inc., Commerce, CA.
OSHA. 2007a. Diacetyl and Food Flavorings Containing Diacetyl
Stakeholder Meeting Notes Stakeholder Meeting, Arlington, Virginia
(October 17, 2007), Meeting Summary Report. Available at: http://www.osha.gov/dsg/guidance/101707-diacetyl-meeting-notes.html.
OSHA. 2007b. National Emphasis Program--Microwave Popcorn Processing
Plants. Directive No. CPL 03-00-005. Available at: http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=DIRECTIVES&p_id=3649.
OSHA. 2007c. Respiratory Disease Among Employees in Microwave
Popcorn Processing Plants. Safety and Health Information Bulletin
SHIB 09-24-07Available at: http://www.osha.gov/dts/shib/shib092107.html.
OSHA. 2007d. Hazard Communication Guidance for Diacetyl and Food
Flavoring Containing Diacetyl. Available at: http://www.osha.gov/dsg/guidance/diacetyl-guidance.html.
Parmet AJ, Von Essen S. 2003. Rapidly Progressive, Fixed Airway
Obstructive Disease in Popcorn Workers: A New Occupational Pulmonary
Illness? JOEM 44(3):216-218.
Pop Weaver[reg]. 2007. Pop Weaver Introduces the First Microwave
Popcorn with Flavoring Containing No Diacetyl. Available at: http://www.popweaver.com/PopWeaverNoDiacetyl.pdf.
Rose C, VanDyke M, Ellison M, Towle M, Martyny J. 2007. Respiratory
Symptoms and Airflow Limitation in Flavoring Manufacturing Workers.
Am J Respir Crit Care Med 175:A17.
Turin L. 2007. Diacetyl Derivatives. World Intellectual Property
Organization. Available at: http://www.wipo.int/pctdb/en/wo.jsp?IA=US2006026827&DISPLAY=STATUS.
Van Rooy, FGBJ, Rooyackers, JM, Prokop M, Houba R, Smit LAM,
Heederik DJJ. 2007. Bronchiolitis Obliterans Syndrome in Chemical
Workers Producing Diacetyl for Food Flavorings. Am J Respir Care Med
176:498-504.
Van Rooy FGBJ, Smit L, Houba R, Zaat VAC, Rooyackers J, Heederik
DJJ. 2008. A Cross Sectional Study on Lung Function and Respiratory
Symptoms Among Chemical Workers Producing Diacetyl for Food
Flavoring. Occup Environ Med. Sept. 19, 2008.
V. Authority and Signature
This document was prepared under the direction of Thomas M.
Stohler, Acting Assistant Secretary of Labor for Occupational Safety
and Health, U.S. Department of Labor. It is issued pursuant to sections
4, 6, and 8 of the Occupational Safety and Health Act of 1970 (29
U.S.C. 653, 655, 657), 29 CFR part 1911, and Secretary's Order 5-2007
(72 FR 31160).
Signed at Washington, DC, this 14th day of January 2009.
Thomas M. Stohler,
Acting Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. E9-1125 Filed 1-16-09; 8:45 am]
BILLING CODE 4510-26-P