6. With regard to solely utilizing reported exposures to organic solvent mixtures,
OWCP does not agree with this recommendation for the following reasons. Organic
solvent mixtures could potentially represent the intermingling of several ingredients
for which a specific solvent could represent a relatively small or high percentage of
the total mixture. The Board has not provided guidance on what it considers a
sufficient proportion of a qualifying solvent ingredient that would qualify an
employee who is exposed to the mixture as being “significantly exposed.” Even if
agreement on such a threshold were possible, OWCP would then need to categorize
such mixtures for the purposes of generalization in case adjudication. OWCP does
not collect or maintain this type of information on mixtures presently. Moreover, in
2013, the Institute of Medicine (IOM) specifically recommended to OWCP that the
program remove information regarding the constituents of mixtures from the SEM.
IOM recommended that SEM only base health effect links on the mixture itself, not
constituent components. Based on this recommendation, OWCP removed from
SEM all information regarding health effects associated with constituents of
mixtures. The recommendation of the Board directly contradicts the considered
recommendation of IOM. In addition to the challenges of defining organic solvent
mixtures, the program has already expressed concern with regard to claimants’ self-
selecting toxic substance exposures. OWCP does not agree that the program should
allow self-reported exposures to organic solvent mixtures on the OHQ to serve as a
sole basis for making factual findings.

7. With regard to the recommendation that solvent exposure be established through
work history and DDWLP, OWCP does not agree with this recommendation
because there is no DDWLP currently maintained in the SEM that relates to
hearing loss.) OWCP added DDWLP to SEM based on specific data linking
performance of specific work processes to a particular health effect. Presently,
OWCP does not maintain any DDWLP related to hearing loss health effects.
Moreover, as noted previously, the existing hearing loss presumption establishes a
standard predicated on solvent exposure as having an additive effect to employees
exposed to excessive levels of occupational noise and solvents.

Recommendation #2

Definition of "chronic respiratory disorder "

The Advisory Board recommends that the following criteria be used to define a clinical course
consistent with a "chronic respiratory disorder" for use in evaluating pre-1993 CBD claims:

i) Respiratory symptoms (e.g. shortness of breath, cough) that are chronic*, and
ii) One of the following:
a) Abnormal pulmonary function tests (PFTs), or

b) Abnormal chest imaging (chest x-ray or CT scan), or
c) Hypoxemia, or


conclusions, the authors indicated that the findings of the study underscored the
need for further research on the ototoxicity of industrial chemicals. This study does
not support the Board’s recommendation that seven (7) years duration of exposure
to solvents and noise is sufficient to trigger a cause and effect between hearing loss
and this level of exposure. OWCP also requests that the Board clarify whether the
seven (7)-year duration should be a consecutive or aggregate period based on the
relevant epidemiological literature. As noted above, OWCP interprets the
characterization of tenure of exposure to mean a consecutive period of exposure to
solvents and noise. If the Board provides additional insight as to its view of this issue
with supporting rationale, OWCP would be in a more informed position to consider
a revision to its current presumption.

With regard to the Board recommendation regarding applicable labor categories
that have significant solvent exposure, as explained earlier, the labor categories
referenced in PM Exhibit 15-4 come from an analysis of specific ototoxic solvents
associated with job titles that also have a concurrent exposure to excessive noise (in
excess of 85 dBA). The Board, in Recommendations #1 and #2, separates labor
categories and solvent exposures into distinct and separate criteria. Moreover,
while the Board references the synergistic effects of noise and solvents in its
rationale, it does not reference noise as being a factor in shaping its hearing loss
presumption recommendations. OWCP requests that the Board clarify whether its
recommendation considers.the combination of noise and the specified solvents, and
if so, the level of exposure to noise that would be required to meet the threshold.

a. With regard to the recommendation to include the broad categories of
“construction and maintenance” in the list of labor categories, OWCP
requests that the Board provide the information regarding this category
OWCP outlined in its November 9, 2017 response to Recommendation #1.

With regard to the Board’s recommendation to add the two toxic substances to the
hearing loss presumption (as mentioned above), based on human studies, OWCP
agrees that it is appropriate to add N-hexane and carbon disulfide to the existing list
of presumptive toxic substances (Envir Health Persp 111(13): 1620-1624, 2006; Int J
Audiol 53(6): 370-370, 2014).

As stated above, as part of OWCP’s presumption for hearing loss, in order to
presume significant exposure, the employee’s employment must have occurred prior
to 1990. The Board’s recommended presumption does not include any such limit.
As with OWCP’s other presumptions, OWCP undertook significant research to
determine that there would have been a higher level of exposure to noise and
solvents prior to 1990, when there were less safety regulations in place. The
Occupational Safety and Health Administration (OSHA) promulgated its Hearing
Conservation Amendment in 1981 with a modification in 1983, and therefore, the
program determined that by 1990, agencies would have had time to comply with the
standards set forth by OSHA with regard to hearing loss. OWCP requests that the
Board provide medical health science justification or specific DOE operational data
that supports the basis for placing no exposure demarcation date for use in the
recommended presumption.


d) Use of respiratory medications such as asthma or COPD inhalers.

*"Chronic" indicates symptoms (or medication usage) that are present for more than three
months, to differentiate from symptoms (or medication usage) related to an acute infection or
other problem that resolves. If the Claims Examiner cannot determine, based on the record,
whether the condition was present for more than three months, then the case should be referred
to a CMC to determine if the condition was a chronic respiratory disorder.

Response:

OWCP agrees with the recommendation of the Board with regard to how it suggests the
program define a chronic respiratory disorder. OWCP procedural guidance now requires
evidence communicating “the existence of a long term, prolonged pulmonary disease
process” (Reference PM Version 1.1, Chapter 18-Eligiblity Criteria for Non-Cancerous
Conditions pg. 200-201). OWCP agrees that the recommendation of the Board is useful in
establishing uniform guidance for physicians to consider when assessing a claim for CBD.
However, OWCP considers it important to allow wide latitude to the reviewing physician to
allow them to determine whether the available medical evidence constitutes the
establishment of a chronic respiratory disorder. As such, OWCP agrees to add the Board’s
recommendation to procedural guidance relating to the assessment of chronic respiratory
disorder in a CBD claim, but it will not apply it as a dispositive standard.

Recommendation #3
Revision of sections of the Procedure Manual and related materials relevant to Part B conditions.

The Advisory Board recommends a substantial revision of sections of the Procedure Manual and
related materials relevant to Part B conditions, taking into consideration the comments in this
document and other feedback from the Advisory Board.

Response:

OWCP welcomes the recommendations of the Board with regard to suggested edits to the
PM regarding Part B conditions. OWCP agrees to consider these comments as part of the
next edition of the PM. In response to the series of additional comment and suggestions in
the section of the report named, “RESPONSES TO DOL’S SPECIFIC COMMENTS AND
QUESTIONS,” OWCP must evaluate those specific recommendations carefully. In the
past, OWCP has worked closely with medical experts to inform how OWCP communicates
medical information in the PM. In addition, OWCP has contractually sought input from
experts in medical health science to develop specific recommendations for assessing
medical evidence relating to occupational illnesses. OWCP will undertake an analysis of
the Board’s input in concert with prior expert advice provided to the program to decide
how to best edit the Procedure Manual. OWCP will also be mindful of Board
recommendations that are within the confines of their statutory mandate versus those that
relate solely to internal procedures.


Department of Labor Responses to Recommendations from the June 2017 Public Meeting
of the Advisory Board on Toxic Substances and Worker Health

Recommendation #1
Presumption for Solvent-Related Hearing Loss
A claim would meet the presumption for solvent-related hearing loss if there is:

(1) A diagnosis of sensorineural hearing loss, and
(2) Significant solvent exposure

Significant solvent exposure is defined as having any one of the following exposures:

(1) Work for at least a total of 7 years (or equivalent) in any of the job titles on the job title
list in current presumption, or in any construction or maintenance job,

OR
(2) Reported exposure to one or more of the following: styrene toluene, MEK, MIBK, N-
hexane, xylene, ethylbenzene TCE, or carbon disulfide on the Occupational Health
Questionnaire (OHQ), or evidence for exposure to organic solvents in the Site Exposure
Matrices (SEM), for at least a total of 7 years (or equivalent),

OR
(3) Reported exposures to organic solvent mixtures on the OHQ, or evidence for exposure to
organic solvent mixtures in the SEM, for at least a total of 7 years (or equivalent),

OR

(4) Solvent exposure for at least a total of 7 years (or equivalent) established through work
history and Direct Disease Linked Work Processes (DDLWP).

Additionally, claims examiners should not routinely deny claims for solvent induced hearing loss

if the worker has had fewer than 7 years of exposure, does not have a DDLWP for task, or is not ina
labor category on list. Claims that do not meet the requirements set forth here but do have reported
exposure to organic solvents for at least 5 years cumulative should be sent for IH review.

Response:

In order to properly respond to this set of recommendations, it is important to clarify the
current hearing loss presumption OWCP utilizes, in its entirety. The Federal (EEOICPA)
Procedure Manual (PM), Exhibit 15-4 provides guidance on the existing hearing loss
presumption applied by OWCP. Unlike the presumption offered in the Board’s
recommendations, in OWCP’s current presumption, ALL of the following must be met:

¢ The file contains a diagnosis of bilateral (emphasis added) sensorineural hearing
loss;

© Verified covered employment within at least one specified job category listed in the
PM for a period of 10 consecutive years prior to 1990; and

© The employee was concurrently exposed to at least one of the organic solvents listed
in the PM.


Hearing Loss References

1)Rosenberg J, Katz EA. Solvents (Chapter 29) In: Current Occupational _&
Environmental Medicine, 4 Edition, Joseph LaDou (eds.) New York: McGraw-Hill,
2007 (p.490-491).

2)Rabinowitz PM, Rees TS. Occupational Hearing Loss-hearing loss due to chemicals
(Chapter 20.2) In: Textbook of Clinical Occupational and Environmental Medicine, 2"
Edition, Linda Rosenstock, Mark Cullen, Carl Brodkin, Carrie Redlich (eds.),
Philadelphia: Elsevier Saunders, 2005 (p.435).

3)Dunn DE, Rabinowitz PM. Noise-hearing loss due to combined exposures to noise and
other factors (Chapter 35) In: Textbook of Clinical Occupational and Environmental
Medicine, 2" Edition, Linda Rosenstock, Mark Cullen, Carl Brodkin, Carrie Redlich
(eds.), Philadelphia: Elsevier Saunders, 2005 (p.896, 900-901).

4)Meyer JD, McCunney RJ. Occupational Exposure to Noise-risk factors for hearing loss
(Chapter 85) In: Environmental and Occupational Medicine, 4 Edition, William Rom,
Steven B. Markowitz (eds.), Philadelphia: Lippincott Williams & Wilkins, 2007 (p.1296).
5)Gagnaire F, Langlais C. Relative ototoxicity of 21 aromatic solvents. Arch Toxicol
79:346, 2005.

6)Kim J, et al. Combined effects of noise and mixed solvents exposure on the hearing
function among workers in the aviation industry. Indust Health 43:567, 2005.

7)Morata TC, Dunn DE, Kretchmer LW, et al. Effects of occupational exposure to
organic solvents and noise on hearing. Scand J Work Environ Health 19:245-254, 1993.
8)Morata TC, Dunn DE, Sieber WK. Occupational exposure to noise and ototoxic
organic solvents. Arch Environ Health 49:359-365, 1994.

9)Johnson AC, Nylen PR. Effects of industrial solvents on hearing. Occup Med 10:623-
640,1995.

10)Sliwinska-Kowalska M, Szmytke EZ, Szymezak W, et al. Effects of coexposure to
noise and mixture of organic solvents on hearing in dockyard workers. J Occup Environ
Med 46:30-38, 2004.

11)Hodgkinson L, Prasher D. Effects of industrial solvents on hearing and balance: a
review. Noise & Health 8:32, 114-133, 2006.

12)Sliwinska-Kowalska M, Prasher D, Rodrigues CA, et al. Ototoxicity of organic
solvents — from scientific evidence to health policy. Int J Occ Med Environ Health
20(2):215-222, 2007.

13)Morata TC, Fiorini AC, Fischer FM, et al. Toluene-induced hearing loss among
rotogravure printing workers. Scand J Work Environ Health 23(4):289-298, 1997.

14) Gordis, L. Estimating Risk: Is There an Association? (Chapter 10) In: Epidemiology
2nd Edition, W.B. Saunders Company: New York, New York, 2000 (p. 160)

15) Last JM. A Dictionary of Epidemiology, Abramson, Greenland, Thuriaux, (Associate
Editors), Oxford University Press: New York, New York, 1983

16) Lilienfeld AM, Lilienfeld DE. Selected Statistical Procedures (Appendix 1) In:
Foundations of Epidemiology, 2nd Edition, Oxford University Press: New York, New
York, 1981 (p. 344)

Exhibit 1 — Hearing Loss References


When it developed this presumption, OWCP determined that human epidemiological
evidence shows that exposure to specific solvents has an additive effect to hearing loss for
employees with concurrent exposure to excessive levels of occupational noise. Scientific
literature published in peer-reviewed journals confirms a relationship between bilateral
sensorineural hearing loss and simultaneous exposure to noise (above 85 dBA) and
solvents. From this literature, the program identified the following list of ototoxic solvents:
Ethyl Benzene, Methyl Ethyl Ketone, Methyl Isobutyl Ketone, Styrene, Toluene,
Trichloroethylene and Xylene. The literature OWCP relied on in developing its hearing
loss presumption is attached (Exhibit 1) for reference.

After it identified those toxins, OWCP proceeded to ascertain the labor categories
maintained in SEM in which employees would have possibly been exposed to those specific
substances. OWCP industrial hygienists further refined these results by classifying those
labor categories most likely to have had the potential for exposure to a constant level of
excessive noise above 85 dBA. The final work product was a list of labor categories that the
program considered to have had likely exposure to both solvents known to be associated
with hearing loss and noise. While OWCP determined that employees in these job
categories likely had exposure to the named solvents, the job categories are very broad, and
the duties of the employees within those categories will vary depending on the facility.
Therefore, when applying OWCP’s presumption, the claims examiner must also establish
that the employee was specifically exposed to one of the seven (7) solvents listed above
(through review of SEM, the OHQ, or other documents in the case file).

With regard to duration, OWCP applied a 10-year unbroken duration of exposure to
solvents and noise in establishing a presumption. OWCP considered the consecutive 10-
year duration standard as a claimant-favorable interpretation of the available human
epidemiologic literature, as the literature overall supported a minimum of 12.3 years’
duration. The literature (human studies) specifically indicated that there was no effect at
five (5) years, seven (7) years and eight (8) years (Envir Health Presp 114(8): 1283-
1286,2006; Ann Occp Hyg 47:493-502, 2003; Inter J Occ Med Envir Health 21(3):191-200,
2008).

With a clear understanding of OWCP’s current presumption and ‘rationale for that
presumption, it is important to clarify the differences and similarities between the Board’s
recommendation and the current presumption:

© While the Board’s recommendations align with OWCP’s requirement that there be
a diagnosis of sensorineural hearing loss and significant solvent exposure, the Board
does not specifically state that the diagnosis must be bilateral.

e Although in its rationale for these recommendations, the Board mentions the fact
that there is a synergistic effect between solvent exposure and noise, in its actual
recommendation, the Board only requires a diagnosis and evidence of “significant
solvent exposure,” then provides a definition of that phrase without making
reference to noise. This is an important difference between OWCP’s presumptions
that include exposure to a certain level of noise and solvent exposure combined,
because the literature does not support hearing loss with solvent exposure alone.

2


In its definition of “significant solvent exposure,” the Board lists four individual
ways this standard can be met. In contrast, OWCP requires a combination of
various factors in order to meet its presumption (which includes a noise
component):

o The Board limits the duration of exposure to seven (7) years of employment,
without indicating that this time period must be consecutive or occur prior to
1990, as in OWCP’s presumption;

co The Board’s recommendation is similar to OWCP’s in requiring that the
employee be employed in one of OWCP’s listed labor categories; however, it
is unclear whether the Board chose this list based on exposure to solvents and
noise. In addition, the Board added the broad category of “any construction
or maintenance job;”

o The Board indicates that even if an employee does not work in one of the
listed labor categories, if he/she reports exposure to one of nine (9) solvents,
or there is evidence of such exposures in SEM for at least seven (7) years,
he/she meets the presumption. OWCP lists seven (7) of the nine (9) organic
solvents in its presumptive list, while the Board adds N-hexane and carbon
disulfide;

o The Board further indicates that even if the employee is not employed in one
of the labor categories, and did not report any exposure to the listed solvents,
he/she still meets the presumption if there are reported exposures to organic
solvent mixtures for at least seven (7) years (without listing any specific toxic
substances within those mixtures); and

o Finally, the Board indicates that even if none of the above are met, if OWCP
can establish solvent exposures through work history or the Direct Disease
Work Link Process (DDWLP) in SEM, the presumption of significant
exposure should be met.

In response to the Board’s specific recommendations on this issue, OWCP requests
additional information from the Board before it agrees to change its current presumption.

1.

2.

OWCP requests that the Board clarify whether the diagnosis of sensorineural
hearing loss should be bilateral.

With regard to the Board’s recommendation to reduce the duration to seven (7)
years, OWCP requests clarification regarding the application of available scientific
evidence. The Board states that significant exposure can mean that an employee
worked for seven (7) years, or equivalent, in any of the job titles from the current
presumption, or in any construction or maintenance job. The rationale supplied to
support this recommendation comes from studies of toluene exposure effects at
seven (7) years (Scand J Work Envir Health 23:289-298, 1997) of exposure. Upon
review of the specific article referenced, Toluene-induced hearing loss among
rotogravure printing workers, it is noted that the mean tenure of the group at the
studied company was seven (7) years, with exposure to both noise and solvents.
However, the authors specifically stated, “Since the workers who participated in the
study had a relatively short noise exposure time, it is likely that they have not been
exposed long enough to allow for the noise effects to be detectable.” In their

3