PopWeaver comments - The Project on Scientific Knowledge and

May 28, 2009
Mr. Robert Burt
Chair, Small Business Advocacy review Panel
Occupational safety and Health Administration
Washington, DC 20210
Dear Bob,
Thank you again for giving Weaver Popcorn Company, Inc. ("Weaver") the opportunity to speak with
your panel on the proposed approach to regulation of diacetyl in the workplace. We fully support
OSHA’s efforts to provide a safe and healthy workplace and we are pleased to have an opportunity to
provide input on your proposed diacetyl regulatory approach.
During our conference call on May 19, 2009 we agreed to provide more detail on two specific aspects of
Weaver's programs, first the medical monitoring program and second the process by which we evaluate
our flavorings.
Medical Surveillance Program
Weaver conducts a medical surveillance program which has many facets. Associates with potentially
high exposures (based on our assessment of their job duties) receive quarterly spirometry test to measure
their pulmonary function ("PFT's"). All other associates receive annual PFT's. The test results and
tracings are reviewed by a board certified pulmonologist. Any associate with a PFT result less than 80%
of predicted is referred for a medical exam by a board certified pulmonologist. If the medical doctor
recommends further testing, a high resolution CT scan is administered at the company's expense.
In addition to the PFT, associates also complete a health questionnaire that is consistent with the NIOSH
health survey. The results are compared with N-HANES III and the results are statistically analyzed to
develop a prevalence rate. An annual report is prepared so that trends in the data can be more easily
noted.
An annual report detailing the results of air monitoring data, PFT results, and the statistical evaluation of
the predicted vs. actual prevalence rate for both self-reported symptoms and doctor-diagnosed
respiratory disease is also prepared.
Weaver has not had a single associate diagnosed with bronchiolitis obliterans. Bronchiolitis obliterans
is the only disease we are aware of that some scientific literature has suggested may be caused by
diacetyl and does not exist in the population at large (those not exposed to diacetyl). Recent attempts to
relate diacetyl to asthma and generalized, non-specific lung disease are unsupported by the science.
Furthermore, attempts to regulate work place exposures to prevent illnesses common in the population is
not sound public health policy.
Weaver Popcorn Company, Inc.
14470 Bergen Blvd., Suite 100 Noblesville, IN 46060
Review of the Safety of Substitute Flavorings
When Weaver first decided to find a substitute flavoring that does not contain diacetyl we were
concerned that substituting an unknown, potentially more hazardous substance for diacetyl may not be
in our associates' best interests. This concern was heightened by NIOSH presentations and published
papers which suggested that acetoin may also be a chemical of concern, or that irritation of the lung and
nasal passages may be exacerbated other chemicals in the overall flavoring. So Weaver established a
policy that no new flavorings will be introduced without laboratory toxicology testing and evaluation by
professional third party providers to determine the chemicals present in the proposed new flavoring. We
have a qualified laboratory conduct both head space analysis and popping volatiles analysis and report
the results to us. The methodology for the chemical analysis is designed to reflect the worst case
scenario with respect to potential worker exposures, not what our workers are actually exposed to while
performing their jobs.
After we have the chemical analysis completed, the results are reviewed by a toxicologist. The
toxicologist we have selected has spent a considerable portion of his career reviewing the components of
food flavorings and the potential health effects of the chemicals in such flavorings. If he is not familiar
with a chemical reported to be present in the proposed new flavoring he undertakes a scientific literature
review to determine what is known about exposures to these chemicals at the levels reported in the
analysis. He then reports back to Weaver’s legal advisors and to Weaver as to whether there are any
chemicals present at levels which create a risk of adverse human health effects. It is only after the
toxicologist has reviewed the analysis and has given us his opinion that the flavoring is safe that the
flavoring is permitted to be used in the Weaver manufacturing plant. We have recently broadened this
testing program to include all components of the microwave popcorn bag.
Other Chemicals Included in Weaver's Industrial Hygiene Monitoring Program
OSHA has inquired about the other chemicals that Weaver has tested for in the air monitoring program
within our plant. These chemicals have changed over time; however, we have tested for the following in
the personal breathing zone or ambient air in the plant: acetic acid, acetoin, acetaldehyde, propylene
glycol and furfural.
In addition to those items which OSHA asked us to address, we would also like to offer our comments
on the following issues with the two versions of the proposed standard.
Should OSHA issue a PEL or an Engineering Standard?
Weaver believes that an engineering standard will be more protective of worker health and safety in this
situation because the science has not conclusively established that diacetyl is the cause of the
bronchiolitis obliterans. To the contrary, many scientists including NIOSH scientists have suggested
that acetoin, or other chemicals may be equally as harmful to workers.
The problem with a PEL is that it only protects against one chemical – diacetyl. Ten years ago we did
not even know that diacetyl was a problem. An engineering standard would protect against all
chemicals, whether we know today that they are harmful or not.
A second problem with the PEL standard is that the science is not far enough advanced to establish a
PEL. The fact that OSHA has suggested 4 different PEL's (0.05, 0.1,0.5 or 1 ppm) is a good example of
the lack of scientific certainty regarding what exposure level is safe and adequately protects associates
without being unduly burdensome on employers. There is no established "No Adverse Effects Level"
Weaver Popcorn Company, Inc.
14470 Bergen Blvd., Suite 100 Noblesville, IN 46060
for diacetyl, so setting a standard is just a "shot in the dark". The most that OSHA is able to state in
support of any specific PEL is that the very low PEL (0.05 ppm) describes a level below which "there is
little evidence that exposures cause adverse health effects". That is a far cry from the certainty that
should be the basis for regulatory decisions.
If a PEL is Adopted It Should Be At A Level That Can Be Reliably Measured
The low end of OSHA's proposed PEL is a level which we feel is unlikely to be able to be measured
reliably in a plant setting. We are not certain that the new OSHA methodology which allows
measurement of this very low level has been reliably field tested. It is not practical to require
employers to measure to levels that laboratories and industrial hygienists are not routinely able to
measure. Weaver recommends a PEL, if one must be adopted, of 0.1ppm and a Short Term Exposure
Limit of 0.2ppm.
We understand the comments made by some small businesses opposing an engineering standard because
it removes the flexibility that many employers would like to have as to how to best achieve compliance
with the standard. We are not suggesting that OSHA should adopt an engineering standard that is
inflexible (for instance which applies the same engineering requirements for all industries) and does not
set reasonable requirements, taking into account the competing interests of worker safety and cost. Our
experience is that many employers will have to adopt the measures discussed in the proposed OSHA
Non-PEL alternative even if a PEL is adopted. An engineering standard may actually assist many small
businesses by removing the uncertainty of whether they will be in compliance (i.e. can they achieve the
PEL) if they install specific engineering controls.
Comments on Specifics of the Proposal
1) Lack of Clarity around Exposure Assessment
The proposal suggests that an initial exposure assessment would need to take place. For the
engineering standard approach it is clear that associates can be grouped and exposure monitoring
can be done for each shift and each job classification. For the PEL approach it appears each and
every associate has to have air monitoring data to satisfy this exposure assessment. That would
be very expensive. Instead we suggest grouping associates with similar jobs and having air
monitoring done for one associate from each group.
2) Exposure Control Plan
The engineering standard requires a written exposure control plan. Although most elements
seem reasonable the "leak prevention, detection and repair procedure" seems to be more
applicable to chemical plants making diacetyl; but not to food manufacturing facilities.
3) Respiratory Protection
The proposed standard requires full face respirators. Diacetyl has very low skin permeability
and therefore half face respirators should provide adequate protection. This would be an
unnecessary expense and is much less comfortable for the associates. When comfort is an issue,
associate compliance is also more difficult to achieve.
4) Protective Work Clothing
The proposed standard requires that contaminated protective clothing must be stored and sealed
in impermeable bags or closed impermeable containers for transportation to the laundry. This
seems to be overkill for most industries that use diacetyl at very low levels. At the very low
levels at which diacetyl could remain on clothing (considering the very low concentrations in the
flavorings to begin with) this does not seem reasonable. This part of the standard may only be
appropriate in the chemical manufacturing setting where diacetyl is present in much higher
concentrations.
Weaver Popcorn Company, Inc.
14470 Bergen Blvd., Suite 100 Noblesville, IN 46060
5) Medical Monitoring
The standard requires a physical exam "every six months" or more frequently when deemed
necessary by a health care professional. This is excessive. If spirometry testing is done and the
associate's lung function is within normal limits, there is nothing that a physical exam will show
that the pulmonary function test did not show. Furthermore, this is an unnecessary substantial
expense. The requirement that a health care professional would have to prepare a written
medical opinion within 30 days after every physical exam is excessive, especially when
combined with the unnecessary requirement of a physical exam for every associate every six
months. This requirement should apply only for physical exams of those associates who have
been referred as a result of an abnormal spirometry test result.
6) What This Standard Does Not Include
The Cal OSHA proposal also set the definition of an "obstructive defect" which triggers
additional medical monitoring (such as a physical exam or High Resolution CT Scan) at 90% of
predicted for the FEV1/FVC ratio. This is not generally accepted in the medical community and
would far overstate the number of associates with obstructive lung defects, which in turn would
lead to a large number of unnecessary exams and other tests. However, it is important to have a
common definition of what pulmonary function test result should trigger additional medical
monitoring. Or, if no agreement can be reached on that issue, the standard should leave it to the
licensed health care provider.
Weaver will continue to work with OSHA to develop an appropriate diacetyl standard. Please feel free
to contact me directly if you have any questions or if you need additional clarification.
Sincerely,
Robert E. Hawk
Vice President
Weaver Popcorn Company, Inc.
Phone: (317) 490-6863
Email: [email protected]
Weaver Popcorn Company, Inc.
14470 Bergen Blvd., Suite 100 Noblesville, IN 46060