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Review of the Department of Labor's Site Exposure Matrix Database (2013)

Chapter: 3 Site Exposure Matrix Dat

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Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
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3

Site Exposure Matrix Database

The Department of Labor’s (DOL’s) Site Exposure Matrix (SEM) database (www.sem.dol.gov) is an important tool in the claims adjudication process for workers and contactors covered by the Energy Employees Occupational Illness Compensation Program Act (EEOICPA) Part E and the Radiation Exposure Compensation Act (RECA). SEM is a Web-accessible database of site-specific information, including a list of toxic substances that have been identified at Department of Energy (DOE) and RECA facilities and covered by EEOICPA Part E. In order to facilitate consolidation of information on DOE facilities, the DOL worked with a contractor to develop a database to store site-specific data, such as a list of DOE EEOICPA-covered facilities, an inventory of toxic substances present at each facility, job descriptions, and production processes. As of October 2012, there were 13,697 toxic substances listed in SEM (DOL, 2012e).

In this chapter, the committee discusses the development, content, structure, and updating of SEM, as well as its strengths and weaknesses. The committee recognizes that the database might be more accurately described as a “hazardous substance” rather than an “exposure” database. Exposure information—that is, the potential of a toxic substance to enter the body and cause harm—includes route (inhalation, dermal, oral), intensity (concentration, dose), duration, and frequency. Such information is not included in the database.

Although the majority of recommendations for improving SEM are provided in Chapter 4, specific suggestions are made in this chapter that could address some of the criticisms DOL has received from the Government Accountability Office (GAO), the DOL ombudsman, and the public. In accordance with its charge, the committee focused on the links between toxic substances and associ-

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
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ated occupational diseases found in SEM. These links are imported solely from the “Diseases” field in the Haz-Map database (see Chapter 2).

USE OF SEM IN THE EEOICPA CLAIMS PROCESS

For context on how SEM is used, DOL provided the committee with an overview of the EEOICP claims process (see Figure 3-1). Each pathway shows that information in the database is not the final determinant of either an exposure pathway (Figure 3-1a) or a toxic substance—disease link (Figure 3-1b). For example, a claims examiner uses the claimant’s employment history to verify that the claimant was potentially exposed to a toxic substance based on location, job category, or process (Figure 3-1a). Based on a claimant’s employment history and medical information, a claims examiner can also check to see whether a causal link between the claimant’s disease and any toxic substance exists in SEM (Figure 3-1b). DOL appears to use “Exposure Pathway” to indicate the presence or absence of a substance at a DOE site. If a causal link is found in the database, the claims examiner can recommend that the claim be accepted if a well-rationalized link between the claimant’s diagnosis and occupational exposure to a toxic substance is supplied by the treating physician and an exposure pathway is evident (Figure 3-1). If a link between a claimant’s disease and exposure to a toxic substance is not given in the database, the claimant may provide additional supporting information and statements from the treating physician regarding the etiology of his or her disease. The claims examiner may further refer the claim to a toxicologist, a district medical consultant, or an industrial hygienist for further evaluation before a decision is made to accept or deny the claim (DOL, 2012e).

SEM is periodically updated. As the introductory website states:

The exposure and diagnosed illness information provided on this website is not complete. Toxic substance use at each facility is continuously evaluated and new substances are added as their presence is discovered. DOL places SEM data on the Internet in an ongoing effort to obtain and organize exposure and disease information for all covered Part E facilities. The website was developed to support DOL Part E claims adjudication. The information presented is not an attempt to provide a complete history of any DOE or RECA facility. (http://www.sem.dol.gov; accessed January 24, 2013)

DOL states that “SEM represents the most current, accurate, and comprehensive information regarding toxic substances and their known health effects, and is updated regularly” (DOL, 2008). The current version of the database used by claims examiners and the version available to the public on the Internet contain the same information, although initially there were differences in the available information due to DOE security concerns. DOL asserts that the security concerns have been resolved and that there are no longer differences between the content of the public and the internal SEM databases (Anders, 2012a).

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
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FIGURE 3-1 The DEEOIC claims process for determining (a) exposure and (b) medical information. This flow diagram was created by DEEOIC staff to describe the use of SEM in the claims process.
NOTE: DAR = document acquisition request; DMC = district medical consultant; Dx = diagnosis; EE 1/2 = employee’s claim form and survivor’s claim form; EE 3 = employment history form; FWP = former worker program; IH = industrial hygiene; OHQ = occupational health questionnaire; RD = recommended decision; SEM = site exposure matrix. SOURCE: Anders, 2012b.

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
×

Any judgment regarding whether exposure to a toxic substance causes a specific health effect requires a clear definition of the exposure of interest. SEM provides a set of indicators showing which exposures are presumed to occur in which occupations. The entries in the database indicate whether a worker in a specific job is considered potentially exposed to a given substance, but they contain no information on the probability of exposure, or the intensity, duration, or route of exposure. In order to assess the validity of links between an occupational exposure and disease, the committee recognized the need to consider the range of exposure scenarios involving concentrations, duration, and route of exposure to a toxic substance.

DEVELOPMENT OF SEM

Development of SEM began in early 2005 with database design criteria and a pilot project. It continues to expand as new information becomes available. DOL’s goal is to identify all possible toxic substances that had been used at DOE sites. The database was populated with data from more than 11,000 documents collected from DOE sites and archives (Stalnaker, 2012). According to the DOL SEM contractor, sources of information included the following:

•   worker and site interviews;

•   record gathering on the substances used at major DOE facilities (e.g., work procedures, industrial hygiene reports, safety analysis reports, job hazard analyses);

•   federal and state agencies (e.g., U.S. Environmental Protection Agency [EPA], State of Colorado);

•   National Institute for Occupational Safety and Health (NIOSH) profiles;

•   textbooks;

•   former Worker Program documents; and

•   other credible sources (as cited by the DOL contractor).

SEM does not indicate the actual source of any of the site-specific information. Therefore, the user is unable to ascertain whether all potential sources of information have been identified and used to develop the list of toxic substances present at a particular site. However, the public, including former workers, may submit both site-related and disease-related information directly to DOL on the database website (see discussion of external submissions to SEM) (http://www.sem.dol.gov/ComposeSubmittal.cfm).

Creating and updating SEM requires DOE cooperation because it must approve the declassification of any site information, including inventories of toxic substances. The database also contains information about occupational diseases that are associated with each toxic substance found at a site. DOL determined that an appropriate source for such associations was Haz-Map, which is published

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
×

online by the National Library of Medicine (NLM), and contains a variety of information about occupational exposures and diseases for more than 7,000 toxic substances (see Chapter 2).

The committee used the publicly available SEM database (http://www.sem.dol.gov/expanded; DOL, 2012e) for its review. The review is based on many hours of accessing the database and an overview of the database by its developer at the committee’s first open session. The committee was not given specific information on the architecture of the database, although its structure affects how the database functions, including its search capabilities. An online user’s guide is available for SEM that explains the database content, how to search for specific toxic chemicals, and how to filter the results (http://www.sem.dol.gov/expanded/help.cfm; DOL, 2012c).

CONTENT AND STRUCTURE OF SEM

SEM is a site exposure—driven database. To access information on toxic substances, the user must first choose a specific DOE site. Although this feature assists users by taking them immediately to a chosen site, the system may be cumbersome for those who worked at more than one site because each site must be searched independently and results cannot be electronically combined.

The database contains information in two general categories: site-specific exposure information for DOE facilities and universal information (all toxic substances and associated health effects) (see Figure 3-2). Each DOE site may be searched for information on site history, labor categories, processes that used toxic substances, areas and buildings where toxic substances were present, and incidents involving toxic substances. For example, a health physics technician at the Alba Craft site may have worked in four different buildings and performed concrete cutting, debris reduction operations, decontamination activities, decontamination and demolition activities, excavation and backfilling activities, and site waste packaging and shipment activities (see Figure 3-3). This worker may have been exposed to cement, diesel exhaust, gasoline, Hantavirus, Histoplasma capsulatum, kerosene, petroleum mid-distillate, and uranium.

Magnifying glass icons next to substances, buildings, and processes indicate that more information is available. In this example, by clicking on the icon next to kerosene, the user can view chemical information and properties for kerosene, the buildings, processes, and labor categories potentially exposed to kerosene at Alba Craft and specific health effects from the Haz-Map database (see Figure 3-3).

Specific Health Effects in SEM

DOL and its contractor control and choose what information from Haz-Map is used in SEM. The “Specific Health Effects” field for each toxic substance in SEM is populated directly from the Haz-Map “Diseases” field (see Chapter 2 and

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
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FIGURE 3-2 SEM search options for a specific DOE site. The Clarksville Facility is shown in this example.
SOURCE: DOL, 2012e.

Figure 3-3). The “Specific Health Effects” field contains health effects information based solely on “established relationships between toxic substance exposures and occupational diseases as reported by the National Library of Medicine (NLM) on its Haz-Map website (http://Haz-Map.nlm.nih.gov)” (DOL, 2012c). Although DOL relies on the NLM Haz-Map database for toxic substance—occupational disease links, NLM does not establish those causal associations as might be implied from that statement. As stated on the NLM website, “the views and opinions of authors expressed on NLM Web sites do not necessarily state or reflect those of the U.S. Government” (NLM, 2012).

No other health effects information from a Haz-Map toxic substance profile (see Chapter 2 for all the database fields) is included in SEM (Stalnaker, 2012). For example, in the kerosene profile, Haz-Map lists “CNS solvent syndrome” and “secondary hepatoxin” as adverse effects and “chronic solvent encephalopathy” and “solvents, acute toxic effect” as the occupational diseases that may result

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
×

image

FIGURE 3-3 Example of SEM record for a health physics technician at the Alba Craft Facility.
SOURCE: DOL, 2012e.

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
×

image

FIGURE 3-4 Example of SEM record for kerosene found at the Alba Craft site. SEM database queried on October 2, 2012.

from exposure to kerosene (see Box 2-1), but, only the latter two health effects are included in SEM (see Figure 3-4). Furthermore, SEM does not include any health effects that are not covered under Part E (e.g., birth defects), even if that health effect is included in Haz-Map, that is, it includes only those health effects that may be compensable under EEOICPA.

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
×

While more comprehensive information about the health effects associated with a toxic substance is available from Haz-Map (for example, skin designations), the DOL explicitly instructs its claims examiners to use only Haz-Map information that is included in SEM. The Claims Examiner Manual states:

The occupational disease links in SEM are imported from the widely accepted and well rationalized medical science database called Haz-Map, a database of the National Library of Medicine (NLM). While the NLM database, Haz-Map, is often utilized in other circumstances as a resource, the claims examiner must never use Haz-Map as a development or adjudicatory tool. Only SEM is acceptable for use in case file development and adjudication. It is unacceptable to base a decision, particularly a remand order, on any information contained in Haz-Map beyond the established links populated directly into SEM. Haz-Map serves many purposes for the public and medical professional fields and will often cite suggestive research that it has not accepted as a basis for finding a demonstrable link between a given substance and an occupational illness. (DOL, 2012b)

Haz-Map, as noted in Chapter 2, contains more than 7,000 agents and 235 occupational diseases (Brown, 2012, 2013), whereas SEM contains 13,697 toxic substances as of October 2012 (DOL, 2012d) and more than 120 occupational diseases (Stalnaker, 2012). Many toxic substances in SEM, such as 1,5-cyclooctadiene platinum II chloride, are not included in Haz-Map and therefore, will have no health effects information available. DOL has developed its own internal guidance on a few occupational disease associations, such as DOL Bulletin No. 08-15, Adjudication of Part E Claims for the Conditions of Parkinsonism and Parkinson’s Disease, May 30, 2008, but these bulletins are not included in SEM. SEM also contains many commercial products, mixtures, and compounds (e.g., 1 Shot Graphic Coat Enamel) that are or have been used at DOE sites, but these substances are not included in Haz-Map. Some substances in Haz-Map are not in SEM because they have not been identified or confirmed as being used at any DOE site, such as carob bean gum; however, these substances are included in Haz-Map because they have been found in other occupational settings. It should also be noted that not every toxic substance listed in Haz-Map has adverse health effects information. This may be because the agent has not been tested for toxicity or it may not be identified with any adverse effects, occupational or otherwise, in the medical, epidemiological, or industrial hygiene literature. Neither Haz-Map nor SEM, however, distinguishes between substance—disease links for which there is no evidence and those where the evidence that does not support a causal relationship between the substance and a disease. The committee believes this lack of clarity about the reason for no link may be confusing if the absence of a link in SEM is always interpreted to mean that the evidence does not support a link.

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
×

Updating SEM Content

Updating the SEM is a continuous process. Although there is no formal schedule for reviewing any specific components (Paragon Technical Services, 2012), DOL indicates that updates are made approximately every 6 months (Karoline Anders, DOL DEEOIC, personal communication, October 9, 2012). According to the DOL and its contractor, the SEM can be updated in three ways: external submissions from the public of site-related or disease-related information; incorporation of Haz-Map updates for health effects links; and receipt of new information from DOE. In the following sections, the committee discusses updates to the SEM based on external submissions of information and on revisions to Haz-Map. Because DOE does not provide health effects information to SEM, nor was the committee asked to comment on DOE activities with regard to it, updates to the database based on DOE information are not discussed further in this report. Regardless of the source of new information for SEM, for security reasons, DOE must approve all updates before they are publicly released.

Although a SEM record indicates when it was last updated, there is no indication as to what specific information or field was updated, added to, or revised. This lack of this information makes it extremely difficult for the user to know if the most current information has been incorporated. For example, the record for o-toluidine was last updated on November 14, 2011, according to the “Record History” field; however, the “Specific Health Effects” field states that “No diseases were listed in NLM Haz-Map (i.e., NLM had not identified any occupational disease related to exposure to this substance) as of June 5, 2012” and “Diseases currently associated with this substance in the Haz-Map database may differ from those associated with it when this page was updated on June 5, 2012,” suggesting that the page had indeed been reviewed as of June 5, 2012 (accessed December 3, 2012). There is no explanation of why the review occurred or what information was being considered. Statements such as these can be confusing to the user.

The committee recognizes that the periodic updating of both Haz-Map and SEM as new information on toxic substances and occupations disease links become available is essential to assisting claimants and claims examiners. The committee encourages these ongoing updates to both Haz-Map and SEM and, therefore, has indicated in its report the dates a link was evaluated, recognizing that since then a link may have been added, revised, or deleted. The committee expects that between the time this report was written and when it is published, there may be additional changes to both databases and, thus, the committee’s statements about a specific link may no longer be accurate. In fact, the committee was told that many revisions were made to SEM in December 2012 (Karoline Anders, DOL DEEOIC, personal communication, January 2, 2013); however, the committee was unable to review these revisions for its report.

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
×

External Submission of Content

External submissions may come directly from claimants, from their representatives or advocates, and from the general public (Stalnaker, 2012). On the SEM homepage, DOL provides a mechanism for public submission of site-related and disease-related information to be considered for addition to the database (see Figure 3-5) (http://www.sem.dol.gov). The SEM homepage states that “comments and documentation regarding the use of toxic substances at covered Part E facilities and documentation of established occupational illness links are welcome.” The DOL contractor told the committee that there is a structured internal process for reviewing submitted information, but no formal external review process.

Another button on the SEM homepage labeled “Status of disease-related input” allows users to view the toxic substance—disease links that have been submitted and indicates whether the proposed link has been accepted by DOL and, therefore, is in the queue to be added to the SEM (see Figure 3-6). Before a toxic substance—disease link is added to SEM it is reviewed by the Haz-Map

image

FIGURE 3-5 Screen capture of SEM homepage indicating highlights for public input.
Source: DOL, 2012d (accessed January 23, 2013).

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
×

image

FIGURE 3-6 Screen capture on information on the status of SEM.
SOURCE: http://www.sem.dol.gov/Status.cfm for aplastic anemia (accessed January 22, 2013).

developer for inclusion in Haz-Map. If the Haz-Map developer accepts the link based on review of the evidence submitted by the public and other sources, the occupational disease is added to Haz-Map, and only then can it be added to the queue for a SEM update, pending review and approval by DOE. Clicking on the disease-related information button on the SEM homepage takes the user to a list of diseases. Once a disease is selected, the user sees a table (see Figure 3-6) that lists the toxic substances for which the disease link has been accepted, is under review, or has not been verified (and thus is no longer being considered for possible addition to SEM).

Updating Health Effects

The toxic substance—occupational disease links in SEM are updated after revisions are made to the occupational disease fields in Haz-Map, because the source of those links is Haz-Map. DOL can make ad hoc requests of the Haz-Map

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
×

developer to review or add substance profiles to Haz-Map to complement data needs in SEM. For example, such a request may be made if new external information is received on a substance or if DOE adds new chemicals for a site. The DOL SEM contractor is required “to ensure that the Haz-Map information used in support of the SEM project is properly managed, evaluated, and input into the system in a timely manner. Furthermore, the Contractor shall ensure that the SEM information is consistent with the information contained in the NLM Haz-Map database” (DOL, 2010). However, there are no contract specifications as to what is meant by “evaluated,” nor is there a requirement that any of the information be formally or informally peer reviewed at any point in the update process.

NLM publishes quarterly updates to Haz-Map, as described in Chapter 2. Changes to the toxic substance—disease links in that database are then imported into SEM for all toxic substances common to both databases. The need for DOE review of each SEM update results in a lag between the availability of new information in Haz-Map and its incorporation into SEM. Given the update schedule for these databases, the committee believes that Haz-Map updates likely take less than a year to appear in SEM. The committee felt that compared with many organizations and governmental agencies, this is an acceptable time frame for updates.

GOVERNMENT ACCOUNTABILITY OFFICE REPORT

In 2008, a highly critical series of articles in the Rocky Mountain News (Denver, Colorado) highlighted many complaints from EEOICPA claimants who reported having difficulty navigating the program, years of delay in compensation, and perceived inconsistencies in how claims are adjudicated. The issue caught the attention of several members of Congress who criticized the program and requested that the Government Accountability Office (GAO) review the implementation of the EEOICPA by DOL. The consequent GAO report (2010) addressed four issues: (1) claim processing time; (2) costs of administering the program; (3) the extent to which there was quality control to ensure that claim determinations were supported with objective and scientific information; and (4) actions taken by DOE, NIOSH, and DOL to improve program transparency for claimants. The GAO “reviewed EEOICPA, relevant regulations, and agency technical and procedural guidance for EEOICPA; interviewed officials from the Department of Labor, Department of Energy, and NIOSH; and interviewed members of the Advisory Board on Radiation and Worker Health, the presidentially appointed board that oversees the scientific validity of NIOSH’s work, and its contractor” (GAO, 2010).

The GAO report concluded that while independent review of Part B, in the form of its Advisory Board on Radiation and Worker Health, provided sufficient oversight for that section of the act, there was no oversight from outside independent reviewers to ensure the scientific soundness of various aspects of the implementation of Part E. Furthermore, the report specifically stated that “Labor

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
×

employs a contractor and a small team of internal experts to continuously update its site exposure matrix. However this effort is not supported by public, outside review to provide assurance that the matrix is comprehensive and scientifically sound” (GAO, 2010). In particular, the report cites the lack of independent review for “the detailed information in the site exposure matrix” (GAO, 2010). GAO had three major recommendations to enhance the oversight and transparency of EEOICPA Part E. First, DOL should strengthen the quality control measures in place for the Part E claims process. A technical review of detailed information in SEM was specifically encouraged. Second, DOE and DOL should formally partner to release more information to be included in the database to better facilitate public access and input. This recommendation also suggested actively seeking feedback from worker representatives and site experts. DOL acted in response to this second recommendation with the release of an expanded version of the SEM database website on January 11, 2011. The new version added six DOE work locations and provided more data for identifying interrelationships between DOE buildings, job categories, work processes, and toxic substances at all locations (DOL, 2011). Third, DOL should develop a formal action plan to respond to its Ombudsman’s annual reports that contain major claimant criticisms (GAO, 2010). Subsequently, the DOL did respond publicly to the Ombudsman’s 2010 Annual Report to Congress in a letter dated April 20, 2011 (Steinberg, 2011).

STRENGTHS OF SEM

The committee commends DOL for developing the SEM database to assist claims examiners and claimants to quickly determine the toxic substances to which a claimant may have been exposed during employment at a DOE EEOICPA-covered facility and the occupational diseases that are associated with exposure to those substances. The committee notes that some of the strengths of the database discussed below are a result of DOL’s response to the issues identified in the 2010 GAO report. The SEM strengths include that it

•   Contains occupational diseases that are linked to toxic substances found at DOE sites.

•   Was developed in consultation with DOE experts and former facility workers. Data was gathered from DOE records at 43 DOE sites, 10 records archives, more than 100 meetings with more than 1,000 current or former DOE workers from 53 facilities, and 20 RECA sites (Anders, 2012a; Stalnaker, 2012).

•   Attempts to be comprehensive for all toxic substances used at DOE sites. It includes more than 13,000 substances and trade name products (for example, WD-40) irrespective of their potential toxicity and the amount of exposure or health effects data available. Substances range from the

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
×

   very toxic, such as chromium VI, to those that do not generally cause harm, such as walnut shells or vitamin B12.

•   Includes all DOE facilities covered by EEOICPA Part E, even those that are no longer in operation. The database lists 116 DOE sites and 4,122 RECA sites (DOL, 2012a; Stalnaker, 2012), including sites that have been closed for decades, such as Sacandaga Facility that was in use from 1947 to 1953 (DOE, 2012), sites that are currently being remediated under Superfund (Rocky Flats in Colorado and sites that are currently in operation such as Savannah River in South Carolina).

•   Is publicly available on the Internet. Claimants, their families, or their representatives, and the general public can access the database at http://www.sem.dol.gov.

•   Allows users to search for a variety of information once a specific DOE facility is chosen (see Figure 3-1) including health effects and toxic substances as well as details about the site itself, such as buildings, processes, labor categories, and site history. A user guide is accessible on the homepage that explains the search functions and fields (http://www.sem.dol.gov/expanded/help.cfm) and the Web interface allows users to drill down through the site-specific information.

•   Is updated approximately every 6 months as new site or health information becomes available (Karoline Anders, DOL DEEOIC, personal communication, October 9, 2012).

•   Provides a mechanism for the public to submit site-related and disease-related information. As discussed earlier, the database may be updated using information that is submitted by the public regarding substances that were present at sites or substance—disease links.

WEAKNESSES OF SEM

Although SEM has several strengths, there are several concerns that hinder its effective use by claims examiners and the public, and several information gaps that should be filled. Generally, these concerns and gaps are due to lack of information in or functionality of the database. The committee specifically found problems with accessing universal information (non-site-specific information); lack of exposure information; incomplete or inconsistent exposure profiles based on location and job; inability to handle complex exposures, including exposure to mixtures and radioactive substances; failure to consider epidemiologic studies of DOE workers; and the sole use of Haz-Map for the toxic substance—disease links. These problems are discussed in the following sections.

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
×

Difficulties in Accessing Information

Although major strengths of SEM are that it is accessible online, is publicly available, and can be searched to identify toxic substances that were present in a building or area at a DOE facility, the committee found that some information was difficult to access.

First, the SEM database is not directly accessible from the homepage (http://www.sem.dol.gov). To access the database, users must follow several steps. At the bottom of the homepage, users must select a facility type, (e.g., DOE facilities, uranium mines, uranium mills, ore-buying stations, or uranium transport) and then select a specific facility on the following page before any further information can be accessed. The user is shown a list of “Toxic substances verified as having been onsite and used at site,” with a link to expanded data on the right-hand side of the website. This “expanded” link directs the user to the database where a different site can be selected. If the user selects no site (that is the blank row at the top of the list) access is given to universal information about toxic substances and health effects (see Figure 3-1). Several links are available that allow users to search and select a substance or health effect of interest. The committee finds that easier access to the database and a direct link to it from the homepage would improve use.

Requiring that a single site be selected initially prevents the user from finding universal information, such as all jobs linked to a specific toxic substance or all health effects in the SEM regardless of the site. While this restriction supports a site exposure matrix and limits searches to toxic substances and health effects for a particular site, it prevents the public from investigating exposures and health effects that may have occurred at more than one site or across sites, except for construction jobs (DOL, 2012c). Furthermore, the limited query and filter abilities of the database inhibit quality assurance or quality control review because access to the universal information on toxic substances and health effects is not direct or easy. Improved query operations to help users more effectively search the SEM would enhance its usability for both claims examiners and claimants.

DOL provides access to a list of occupational diseases on the SEM home page (accessible at http://www.sem.dol.gov/Dis.cfm) for “substances with an established causal link to the diagnosed illness as accepted by NLM.” The descriptor for the list is misleading, however, because some the substances are commercial products and mixtures (such as BTEX) that are not in Haz-Map and, therefore, do not have the corresponding established disease links. The list of occupational diseases is external to SEM and is not harmonized with information found within the database itself (Karoline Anders, DOL DEEOIC, personal communication, October 9, 2012). Differences between this list and SEM are due to delays in updating. For example, in October 2012, 68 toxic substances are linked to aplastic anemia in the external list, but only 64 substances are listed as causing aplastic anemia using the “Universal Search” within the expanded SEM.

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
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Likewise, 32 substances are linked to laryngeal cancer in the external list, but only 29 are listed in SEM (accessed October 4, 2012).

Lack of Exposure Information for Toxic Substances

SEM is used to confirm the potential presence of a toxic substance at a DOE facility and then to begin the process of determining whether a worker at that facility may have been exposed to the substance and whether his or her disease may be a consequence of that exposure. Generally, to conclude that a disease is caused by exposure to a toxic substance, an exposure assessment is conducted. For a toxic substance—disease link to be causal, the exposure must occur before the health effect, although some exposures may exacerbate existing diseases such as asthma. A formal exposure assessment is “the process of measuring or estimating the intensity, frequency, and duration of human exposures to an agent currently present in the environment or of estimating hypothetical exposures that might arise from the release of new chemicals into the environment.” In its most complete form, it describes the magnitude, duration, schedule, and route of exposure; the size, nature, and classes of the human populations exposed; and the uncertainties in all estimates (NRC, 1983). SEM does not contain qualitative or quantitative exposure data, such as air monitoring, or the concentrations (percent by weight) of components of trade name products.

The committee does not know whether or how DEEOIC claims examiners conduct quantitative exposure assessments for Part E and if the exposure assessments are similar to the radiation dose reconstructions developed by NIOSH in support of Part B claims. The committee also does not know how DOL assesses exposure pathways (see Figure 3-1) because assessment is conducted outside of SEM.

Incomplete Site Exposure Profiles

DOL acknowledges that SEM is incomplete. The committee found numerous examples where the lack of toxic substances information for a site could potentially impact claimants. There are several reasons why information may be missing in the database for example, DOL may never have received any documentation or confirmation from DOE that a substance was present at a site. For example, at the Ames National Laboratory, the database indicates that 33 of the 39 buildings contain toxic substances. Information on processes/activities performed in the buildings is available for 36 of the 39 buildings. However, the database identifies only 10 of the 39 buildings with labor categories that might potentially encounter toxic substances. Therefore, the labor categories are not linked to substances that were present based on process and building. Although toxic substances were found in 23 of the 53 buildings at the Albany Research Center, “remediation worker” is the only labor category listed as potentially

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
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encountering those toxic substances. There is no information on labor categories, toxic substances, or processes or activities for the sheet metal, welding, paint, and electrical and electronics shops—areas where exposures to toxic substances would be expected. The extent to which other sites lack information on labor categories for processes or activities that potentially involve exposure to toxic substances is not clear, but should be assessed. These missing toxic substances for labor categories or processes were considered by the committee as a major weakness because links to associated diseases would be missed.

The committee suggests three methods to help identify missing information on substances present at the DOE facilities. First, DOL may draw on similarities between DOE sites where workers performed similar tasks or functions. For example, if there is a wealth of information about toxic substances at one site and a similar site has little information, DOL could reasonably make the assumption that exposures for comparable labor categories, processes, and so forth, would be the same for the second site until more site-specific information becomes available.

Second, some toxic substances are commonly used for a particular job or labor category regardless of the site at which the worker was employed. Therefore, it would be reasonable to expect that such exposures probably occurred even if the substance is not listed for the site (e.g., plumbers are commonly exposed to lead and asbestos regardless of the specific site). Some of this information is available from sources such as Haz-Map or NIOSH’s National Occupational Exposure Survey Data for Potential Exposures to Agents by Occupation (NIOSH, 1990).

Third, diseases associated with certain occupations (labor categories), regardless of specific substance, could be added to SEM if those occupations are known to have been conducted at a site. For example, the International Agency for Research on Cancer (IARC) has evaluated the health effects associated with painting (a known carcinogen causing lung and urinary bladder cancer), fire-fighting (a possible carcinogen), and shift work (a probable carcinogen) without regard for exposure to specific toxic substances (IARC, 2010).

Inability to Assess Complex Exposures

DOL stated to the committee that “SEM handles all exposures individually and is not designed to gauge the effect of co-occurring exposures” (DOL, 2012f). However, most workers in industrial settings, including DOE facilities, would be expected to experience complex exposures to a single substance multiple times, to multiple substances a single time, or to a multitude of substances a multitude of times. Furthermore, the frequency, intensity, and duration of these exposures can vary widely from one time to the next and from substance to substance. In the following sections, the committee discusses the effects of mixtures and chemical

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interactions, including chemical—radiation interactions, on the development of disease.

Mixtures

For some mixtures, SEM lists health effects that are associated with the components of a mixture, whereas for other mixtures the links are given for the mixture as a whole. For example, the health effects for diesel engine exhaust and coal tar pitch volatiles in the database are those associated with the mixture itself and not with the individual constituents. However, the following are examples of where the database has links for the individual components in a mixture but not for the mixture itself:

•   Gasoline exhaust is associated with 29 possible diseases (e.g., aplastic anemia, bronchiolitis obliterans, male and female infertility) based on Haz-Map disease links to 38 individual toxic substances found in gasoline exhaust. However, Haz-Map does not have an agent profile specific to gasoline engine exhaust.

•   Welding fumes are associated with 38 illnesses and diseases, including occupational asthma, bronchiolitis obliterans, acute toxic encephalopathy, spontaneous abortions, and metal fume fever based on Haz-Map links for 43 toxic substances. However, in it, exposure to “welding fumes, not otherwise specified (NOS),” is associated with “pulmonary disease, chronic obstructive” and “pneumonitis, toxic” only.

SEM includes a disclaimer that states “diseases presented for the individual components of the product may not necessarily be indicative of the health effect of the product.” However, including information on the health effects of a mixture based on the components of the mixture, instead of using available health effects information on the whole mixture, is inconsistent with existing guidance for assessing the risk of chemical mixtures (ATSDR, 2012a; EPA, 1986, 2000) and can result in the omission of important toxic substance—disease links or erroneous inclusion of health effects for which there is no evidence.

Many of the mixtures used at DOE sites were trade name products, but SEM does not include the identity of the manufacturer, the dates of manufacture, or the component concentrations of these products. Product components and their concentrations can change over time for any number of reasons and therefore, it is important to capture the date of use of a product so that the component list is accurate and any conclusions about links between a given product and diseases are based on the correct product composition. For example, the database indicates that several products, including Pyromark Series 2500 Flat Black Paint, and Scotch-Grip Brand Contact Cement 1357, contain benzene (in addition to other toxic substances); therefore, these products are listed as causative for aplastic

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
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anemia. The product dates, manufacturers, and benzene concentrations in these products are not provided. Material Safety Data Sheets (MSDSs) obtained online for Pyromark Series 2500 Flat Black Paint (dated June 12, 1990) and Scotch-Grip Brand Contact Cement 1357 (dated March 20, 2003) indicate that they do not contain benzene. The period during which these two products contained benzene, the amount of benzene they contained, and the time these products were used at any DOE site are not provided. Thus, the causal association in SEM between aplastic anemia and these two products, both assumed to contain benzene, may be inaccurate.

Lacking information on a product’s components, its uses, the potential for exposure, and any additive, synergistic, or antagonistic reactions among components may result in the assumption that any amount of the product or its components can cause the diseases for which Haz-Map has established a link. This aspect of the product/disease association in SEM is overly broad, lacks scientific rationale, and may be misleading. Using only SEM links, it would be logical for a claims examiner or claimant to assume that the risks of developing any of the linked diseases is the same for all components of the mixture regardless of the actual product composition and how it is used. Without appropriate contextual information, the potential for misinterpreting the SEM toxic substance—disease links is substantial.

Chemical—Chemical Interactions

When individuals are exposed to multiple toxic substances, the nature of health effects resulting from exposure to any one of them is likely to be unchanged, although the magnitude of the effects may vary as a result of interactions among the substances. That is, if a mixture contains a component that individually acts as a neurotoxin and one that acts as a vasodilator, both of these components in the mixture are likely to continue to exert their peculiar effects, but the intensity (magnitude) of each of those effects may be greater, lesser, or unchanged because of the presence of the other components. This variation in health effects is knows as a chemical—chemical interaction and these interactions may be additive, synergistic, potentiative, or antagonistic, as described in Box 3-1. The committee has not provided a detailed description of synergism or the related concept of statistical interaction but, rather, refers to basic definitions of chemical—chemical interactions used in standard toxicological references. A more detailed discussion of the identification, estimation, and interpretation of the consequences of synergism would require addressing several complex issues, including the dependence of the identification of synergism on the selection of the statistical model (e.g., multiplicative versus additive), the failure of many methods of identifying synergism to adequately consider underlying biological mechanisms, and the slightly different terminology and perspective of different disciplines (e.g., toxicology, epidemiology, statistics). The committee considered

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
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BOX 3-1
Types of Chemical Interactions and Examples

Additive: For a given effect, the combined magnitude of two or more chemicals is equal to the magnitude for the individual chemicals, i.e., 3 + 4 = 7

Cadmium, arsenic—kidney toxicity (ATSDR, 2004b; Mahaffey and Fowler, 1977; Mahaffey et al., 1981)

Synergistic: For a given effect, the combined magnitude is greater than the magnitude for the individual chemicals, i.e., 3 + 4 = 9

Asbestos, smoking—lung cancer (ATSDR, 2001; Erren et al., 1999) Carbon tetrachloride, ethanol—liver effects (Eaton and Gilbert, 2008)

Potentiative: The chemical does not cause effects by itself, but increases the magnitude of effect for another chemical, i.e., 0 + 4 = 6

Isopropanol, carbon tetrachloride—liver toxicity (isopropanol does not cause liver toxicity, but can increase liver toxicity caused by carbon tetrachloride) (Eaton and Gilbert, 2008)

Antagonistic: For a given effect, the combined magnitude is less than the magnitude for the individual chemicals, i.e., 3 + 4 = 5

Cadmium, lead—renal toxicity (ATSDR, 2004b; Mahaffey and Fowler, 1977; Mahaffey et al., 1981)
Toluene, benzene—bone marrow toxicity (Plappert et al., 1994)

synergism as required by its the statement of task, but notes that synergism is just one of several types of chemical—chemical interactions that may occur from exposure to multiple chemicals at DOE sites.

Chemical interactions may occur because of toxicokinetic factors—for example, one chemical may enhance the dermal absorption of another chemical, or one chemical may alter the distribution and excretion of another chemical. Interactions can also occur because one substance modifies the metabolism of another—for example, by inducing or inhibiting metabolic enzymes, or by competitive inhibition (Eaton and Gilbert, 2008). Synergistic or potentiative interactions, for which toxicity of a chemical in a mixture is greater than when the chemical is present by itself, can occur if substances affect different components of the same physiological process, such as metabolic pathways or mechanisms that repair or protect cells from damage (European Commission, 2012).

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
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To the extent that synergistic effects between toxic substances may occur, the majority of effects appear to be additive (Ikeda, 1988; Kortenkamp and Hass, 2009). For example, Ikeda (1988) found that of 62 cases of chemical—chemical and chemical—physical interactions reported in studies between 1981 and 1987, 42 resulted in effects that were either additive or less than additive. In cases where the effect was greater than additive (that is, synergistic), exposures were very high. The Agency for Toxic Substances and Disease Registry (ATSDR) has also evaluated interactions for groups of chemicals found at hazardous waste sites. Of 380 different binary combinations of chemicals, 41 percent of the interactions were additive, 15 percent were antagonistic, and 20 percent were synergistic (Pohl et al., 2009). Because the majority of chemical interactions are additive, scientific and regulatory agencies recommend assuming such interactions as a default approach for evaluating exposure to multiple toxic substances (e.g., ATSDR, 2004a; EPA, 2007a). However, because SEM does not include quantitative estimates of risk, the differences between additive and synergistic effects may be less important for mixtures cited in it.

Some of the most well-studied interactions are between occupational exposures and nonoccupational exposures, in particular, smoking and alcohol. Examples of these interactions are given in Box 3-2.

Synergy Between Radiation and Chemical Exposures

Chemical interactions may be particularly relevant for workers who are exposed to radiation—which can act as a tumor initiator by changing normal cells into cancerous cells—and to toxic substances—which can act as tumor promoters by encouraging the growth of cancerous cell. Such interactions may enhance the potency of radiation exposures (Little, 1990).

Evidence of synergism between radiation and toxic substance exposures in occupational settings is scarce although some evidence from nonoccupational settings is available. Synergism between radiation and toxic substances is discussed by Chen and McKone (2001) who note that the risk of secondary acute leukemia is significantly higher for patients treated with both chemotherapy and radiation compared with patients treated with radiation alone. Synergistic interactions between radiation and chemicals has also been observed in mice and rats for various tumor types, including lung (in mice treated with procarbazine and x-rays), mammary (in mice treated with 7,12-dimethylbenzanthracene and ionizing radiation and rats treated with diethylstilbestrol/estrogen and ionizing radiation), and liver (in mice treated with carbon tetrachloride and neutron irradiation). At present, however, there is insufficient evidence to determine whether synergistic interactions between radiation and chemicals would occur in humans (Chen and McKone, 2001).

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
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BOX 3-2
Examples of Interaction Effects Between Occupational and Nonoccupational Exposures

Smoking:

Asbestos and smoking image Lung cancer (Frost et al., 2011; Reif, 1984)

Arsenic and smoking image Lung cancer (Hertz-Picciotto et al., 1992; Tapio and Grosche, 2006)

Cadmium and smoking image Kidney cancer (Reif, 1984)

Radon and smoking image Lung cancer (Mauderly, 1993)

Uranium and smoking image Lung cancer (Reif, 1984)

Vapors, gas, dust, or fumes and smoking Chronic obstructive pulmonary disease (Blanc et al., 2009)

Alcohol:

TCE and alcohol image Upper gastrointestinal and liver tumors (Caldwell et al., 2008)

Vinyl chloride and alcohol image Hepatocellular carcinoma (Mastrangelo et al., 2004) [note: vinyl chloride is linked with hepatocellular carcinoma (listed as liver cancer) in Haz-Map and SEM]

Dealing with Multiple Exposures in SEM

Chemical—chemical and chemical—radiation interactions are not captured in SEM. DOL informed the committee that “in general, the concept of synergistic/additive effects is not widely accepted in the scientific literature, and for this reason, DEEOIC also does not recognize synergistic/additive effects per se” (DOL, 2012f). The committee disagrees with this assessment and finds that the potential for chemical interaction is widely recognized in the scientific literature, and regulatory agencies such as EPA and ATSDR have issued guidance on addressing combined exposures to multiple chemicals, including chemical interactions (ATSDR, 2004a; EPA, 2007a; European Commission, 2012). The committee also finds that the evidence for chemical—radiation interactions for substances in SEM is not strong enough to make conclusions about causal associations at this time, although research is ongoing. As new information becomes available, these issues should be reassessed.

Because toxic substances interactions are more likely to influence the magnitude rather than the nature of health effects (i.e., synergistic or potentiative

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
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interactions would cause effects at lower exposure levels), assessing interactions for complex exposures to multiple substances requires knowledge of the amount of exposure to each substance. Because SEM does not include information on the duration, concentration, or route (inhalation, ingestion, skin contact) of exposure, it is unlikely that chemical interactions could be linked to specific health effects with accuracy and confidence. However, substances for which there is sufficient evidence of synergistic or potentiative interactions could be flagged or listed in a new field in SEM to trigger additional review by appropriate scientific staff.

Failure to Incorporate Epidemiologic Studies of DOE Workers

The committee asked DOL if and how epidemiologic studies of DOE workers are incorporated into SEM. DOL acknowledged the wealth of data on DOE workers but indicated that such studies were not useful because they pertained to radiation health effects, which is outside the scope of the database. For exposure information, DOL incorporated in it only one report that indicated that mercury1 was used at Oak Ridge (DOL, 2012f).

Many studies have been conducted to assess health outcomes in DOE workers. Although most of them do in fact focus on radiation exposure, the committee found some studies of DOE workers with information on occupational exposures by specific jobs or aspects of employment (such as Kubale et al., 2008; Loomis and Wolf, 1996; Makie et al., 2005; Polednak and Hollis, 1985; Reyes et al., 1984; Richardson et al., 2007). There are fewer studies that estimate exposure to specific substances (Carpenter et al., 1988; Chan et al., 2010; Dement et al., 2003; Godbold and Tompkins, 1979; Ritz, 1999). For example, an analysis of data maintained by DOE’s comprehensive epidemiologic data resource of 3,814 uranium processing workers at the Fernald Feed Materials Production Center specifically looked at cancer mortality associated with use of trichloroethylene, cutting fluids, and kerosene. Several cancer sites were significantly related to exposure to these substances (Ritz, 1999). The committee acknowledges that a scientifically rigorous causal relationship should not be based on one study alone and that additional evidence (such as animal or mechanistic studies, case reports) is needed to support the relationship. Nevertheless, studies such as that by Ritz (1999) might be useful because they are conducted in the population of interest—workers at DOE facilities—and provide specific site, job, process, and in particular, exposure information. The committee urges DOL to reconsider the epidemiologic and medical surveillance studies conducted on DOE workers to inform substance—disease links in SEM.

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1 “Mercury Releases from Lithium Enrichment at the Oak Ridge Y-12 Plant—A Reconstruction of Historical Releases and Off-Site Doses and Health Risks (January 7, 1999) (Anders, 2012a).

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
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Use of Haz-Map for Causality in SEM

Haz-Map was developed to provide a causal link between a toxic substance and an occupational disease, information that is not provided as concisely or simply by other databases. Although the availability of toxic substance—disease links in SEM is a major strength of the overall database, the sole use of Haz-Map to provide those links is problematic for several reasons (also see Chapter 2). Because of SEM’s reliance on only Haz-Map, its links lack

•   external peer-review;

•   transparent references and supporting documentation;

•   explicit causal criteria for noncancer effects; and

•   indication of weight-of-evidence evaluations.

As discussed in Chapter 2, the Haz-Map database was developed for a different purpose than SEM.

Interpretations of Causality

The DOL interpretation of the statutorily imposed causative burden in the claims process is not part of the committee’s charge. However, the committee believes it is important to discuss SEM’s reliance on the Haz-Map criteria for establishing toxic substance—disease links because these may affect the interpretation of what constitutes a causal link.

Haz-Map uses strict criteria for identifying toxic substances that cause cancer (IARC Group 1), but has ambiguous criteria for identifying toxic substances that cause noncancerous occupational diseases (see Chapter 2). EEOICPA states that an illness or disease may be compensable if “it is at least as likely as not that exposure to a toxic substance at a DOE facility was a significant factor in aggravating, contributing to, or causing the illness.” The “Diseases” field of Haz-Map does not capture information on exposures that aggravate or contribute to diseases.

For EEOICPA Part B, quantitative risk assessment methods are used to estimate a claimant’s ionizing radiation dose and the probability (or distribution of such probabilities) that their disease was caused by their occupational radiation exposure. Risk assessments may be conducted even under conditions of uncertainty regarding the strength of the association between an exposure and an outcome.

Unlike Part B, probability of causation calculations are not used for EEOICPA Part E. One reason is that such calculations require exposure information for chemicals and quantitative risk coefficients for each chemical exposure and outcome in order to calculate individual probabilities of causation; neither is available for the majority of scenarios encountered by claims examiners. Therefore,

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
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for Part E, claims examiners make judgments about the etiology of a claimant’s diseases on a case-by-case basis, using information on what toxic substances are accepted causes of the disease, the magnitudes of the claimant’s exposures, and temporal characteristics, such as induction and latency periods. SEM serves as a guide to substances that are causes of specific diseases. However, it does not provide a framework, such as the one formalized for probability of causation calculations under Part B, for incorporating uncertainty into judgments on causation.

Information Sources for Evaluating Human Health Effects

Although the use of Haz-Map for toxic substance—disease links in SEM has advantages such as the relatively large number of substances in the former and the established links for those substances, the committee finds that Haz-Map should not be the sole source of such links for SEM and suggests that other databases and information sources should be considered by DOL. SEM would benefit from adding exposure and toxicological information, for example, the route and the levels of exposure. For example, the Haz-Map database includes information such as permissible exposure limits (PELs) and skin designations that are not imported into SEM. Exposure limits, such as PELs and threshold limit values (TLVs), are useful because they provide qualitative information about the potency of a substance. Substances with lower PELs or TLVs are more potent or toxic than ones with higher TLVs or PELs. Skin designations provide qualitative information on the potential for exposure. Substances that have skin designations can enter the body through skin absorption and inhalation, so the toxic effects are potentially increased. Incorporation of such additional information from Haz-Map or other sources may facilitate DEEOIC’s ability to better evaluate the link between substance and disease for an individual.

The committee identified several databases and other resources that would populate health effects information in SEM. While some of these attributes are subjective, the committee considered them in the context of SEM and EEOICPA needs. These attributes include

•   weight-of-evidence evaluations for occupational health effects and exposures,

•   peer review,

•   easy to use,

•   transparent with methods clearly described,

•   field contents appropriately referenced,

•   communicative so that toxic substance—disease linkages are clear and accessible to nonexpert audiences,

•   publicly available for free or minimal cost, and

•   comprehensive.

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
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There are many authoritative organizations that conduct evaluations of health effects of toxic substances, including occupational exposures and diseases, with the above-mentioned attributes. Table 3-1 lists some sources that the committee believes are particularly relevant and useful to augment the toxic substance—occupational disease links in SEM. Although many of these sources are in Haz-Map’s reference list, it is not clear if they are regularly consulted or if the Haz-Map profiles are updated as new evaluations are made available. There is also additional detailed information available in these sources that Haz-Map does not incorporate.

Several of these information sources assess health effects primarily on the basis of human data; however, some also incorporate animal and mechanistic studies as supporting evidence (e.g., IARC monographs). These assessments generally follow a systematic methodology for collecting and analyzing data, are comprehensive, undergo extensive internal and/or external peer review, and are publicly available on the Internet free of charge, except for ACGIH TLV documentation, which has to be purchased and does not undergo external peer-review. Most importantly, these assessments are based on a weight-of-evidence approach and document the evidence used. Other databases are available that contain a wealth of data about health effects associated with toxic substances, such as the NIOSH Registry of Toxic Effects of Chemical Substances (RTECS; http://www.cdc.gov/niosh/rtecs); however, these databases vary by cost, extent of technical or peer review, and evaluation or synthesis of data.

Laamanen and colleagues (2008) reviewed more than 800 toxicological databases that might be used by occupational health professionals. To assess usefulness, content quality, and ease of use, each database was evaluated on the basis of the availability of a search engine, the factual information on toxic substances, and user costs. The authors found five databases to be particularly useful for occupational health professionals: GESTIS, an international database of occupational exposure limits (http://www.dguv.de/ifa/en/gestis/limit_values); ESIS, the European chemical Substances Information System that contains inventories of chemicals, their use, import and export, and associated hazards (http://esis.jrc.ec.europa.eu); the NLM Hazardous Substance Data Bank (HSDB) and TOXNET, a NLM search product that links to many databases (http://toxnet.nlm.nih.gov); and the NIOSH Pocket Guide to Chemical Hazards (http://www.cdc.gov/niosh/npg).

Bibliographic databases such as NLM’s PubMed and TOXLINE are also potentially useful resources for information on toxic substances that have not been evaluated by any authoritative organizations. However, results from searches of bibliographic databases would require DOL to interpret the meaning, accuracy, and reliability of the data. Bibliographic databases are not included in Table 3-1 for this reason. HSDB is a unique resource because it contains actual quotes that are peer-reviewed by a panel of experts for more than 5,000 substances (HSDB, 2012). Although the experts do not synthesize the information in HSDB to make

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
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TABLE 3-1 Additional Sources of Health Effects Information

Name Authoring Authoritative Organization Web Address
IARC Monographs* World Health Organization http://www.iarc.fr
Report on Carcinogens* U.S. Department of Health and Human Services, National Toxicology Program http://ntp.niehs.nih.gov
Health Assessment and Translation Evaluations U.S. Department of Health and Human Services, National Toxicology Program http://ntp.niehs.nih.gov​/?objectid=4980AA81​-E919-4E85-​60B789CA36E59FA5
Integrated Risk Information System (IRIS) Summaries and Toxicological Reviews U.S. Environmental Protection Agency http://www.epa.gov/IRIS/
Toxicological and Interaction Profiles U.S. Department of Health and Human Services, Agency for Toxic Substances and Disease Registry http://www.atsdr.cdc.gov​/toxprofiles/index.asp
Technical Support Documents for Describing Available Cancer Potency Factors* California Environmental Protection Agency, Office of Environmental Health Hazard Assessment http://www.oehha.org/tcdb
Pocket Guide to Chemical Hazards U.S. Department of Health and Human Services, National Institute of Occupational Safety and Health http://www.cdc.gov/niosh/npg/
Criteria Documents U.S. Department of Health and Human Services, National Institute of Occupational Safety and Health http://www.cdc.gov/niosh​/pubs/criteria_date_desc​_nopubnumbers.html
Current Intelligence Bulletins U.S. Department of Health and Human Services, National Institute of Occupational Safety and Health http://www.cdc.gov/niosh​/pubs/cib_date_desc​_nopubnumbers.html
Preambles to Final Rules U.S. Department of Labor, Occupational Safety and Health Administration http://www.osha.gov/pls/oshaweb​/owasrch.search_form​?p_doc_type=PREAMBLES​&p_toc​_level=0
Threshold Limit Values (TLVs®) Documentations American Conference of Governmental Industrial Hygienists http://www.acgih.org/TLV
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Name Authoring Authoritative Organization Web Address
Technical Support Documents for Describing Available Recommended Exposure Levels (for noncancer effects) California Environmental Protection Agency, Office of Environmental Health Hazard Assessment http://www.oehha.ca.gov/air/allrels.html
Proposition 65 Hazard Identification Documents California Environmental Protection Agency, Office of Environmental Health Hazard Assessment http://www.oehha.ca.gov​/prop65​/hazard_ident​/hazard_id.html

* For cancer effects only.

toxic substance—disease associations, the database may be particularly helpful as a starting point for more information. Similarly, TOXNET (also available from NLM) is not a database itself but, rather, allows users to access and search multiple databases (ChemIDplus, TOXLINE, HSDB, CCRIS, DART, GENETOX, IRIS, ITER, TRI, Haz-Map, Household Products, TOXMAP, CPDB, CTD) (TOXNET, 2012; http://toxnet.nlm.nih.gov). TOXNET is also a useful resource for toxicologic and health effects data.

The committee did not consider MSDSs to be useful for providing additional health effects information on commercial products in SEM. The quality varies and the health effects information can be unreliable and outdated. However, manufacturers of commercial products must list all hazardous components and their percentages that compose more than 1 percent of a product;2 therefore, the committee finds that MSDSs may be useful for augmenting exposure information in the database.

No database known to the committee provides indicators of causal relationships between substance and disease as does Haz-Map. Therefore, to capture the wealth of information provided by these bibliographic databases, trained and knowledgeable individuals would be needed to synthesize all the data and make judgments about causal substance—disease links. The committee noted that all of these information sources and databases would require some interpretation to distill and analyze the data to achieve the causal substance—disease links that the SEM currently contains.

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2 “[A] component present in the mixture in concentrations of less than one percent (or in the case of carcinogens, less than 0.1 percent) could be released in concentrations which would exceed an established OSHA permissible exposure limit or ACGIH Threshold Limit Value, or could present a health risk to employees in those concentrations, the mixture shall be assumed to present the same hazard.” OSHA Hazard Communication 1910.1200(d)(6). http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10099 (accessed February 7, 2013).

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
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TOXIC SUBSTANCE—DISEASE LINKS NOT IN SEM

In order to evaluate the potential for “missing” links between occupational diseases and toxic substances in SEM, as directed by its statement of task, the committee designed an exercise to evaluate some selected links. A nonrandom sample of 81 toxic substances was selected to identify cancer and noncancer disease links that are not in the database. Some of the sample substances were collected from information submitted by the public for DOL consideration and the substances were listed as “under review” or “not verified” on the SEM website (http://www.sem.dol.gov/StatusD.cfm, as of July 2012), other substances in the sample were brought to the attention of the committee by claimant representatives. The committee purposely selected substances that did not have disease links in SEM that claimants thought should be there, and for which they had submitted information to DOL to support the proposed links. Fifteen additional substances were identified by the committee from authoritative sources (e.g., IARC, ATSDR, EPA, and California Environmental Protection Agency [Cal/EPA]) using its expert judgment for a total sample of 96 substances (see Appendix B for the complete list of substances reviewed by the committee). The committee did not conduct a systematic or comprehensive assessment of all 13,697 substances and 129 occupational diseases in SEM. The committee’s assessments of toxic substance—disease links that are not in SEM are shown in Tables 3-2 through 3-4.

The committee recognizes that SEM and Haz-Map are active databases that undergo frequent updates. However, the updates made it difficult to accurately describe the current status of links within both databases. The committee’s review reflects the status of the databases as of October 1, 2012; however, during that month, Haz-Map substantially revised its description of how toxic substances are classified as carcinogens (haz-map.com, accessed October 30, 2012).

For the purpose of the exercise, the committee consulted evaluations of the 96 toxic substances conducted by authoritative sources. The committee considered an authoritative organization to be a government or nongovernment entity whose scientific findings on the health hazards of toxic substances are relied upon by governments and their supporting public health entities in regulating or otherwise protecting public health. In addition to providing evaluations of toxicological information on the basis of the weight of scientific evidence, the organizations also include citations to the specific studies upon which the evaluations are based. The evaluated information also has undergone peer review, and in many cases, public review, except for ACGIH TLV documentations. ACGIH was included as an authoritative organization for this exercise because ACGIH TLVs are the basis for most of the current OSHA PELs (Rappaport, 1993) and many of the NIOSH Recommended Exposure Limits (NIOSH, 2005).

Links not listed in SEM are referred to as “missing,” however, this should be interpreted with caution as the committee recognized that

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
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•   any examination of “missing” toxic substance—disease links in SEM would not be comprehensive because it currently contains more than 13,000 substances and 129 diseases;

•   the identification of links as “missing” may not be accurate because the toxic substance—disease links in the database are periodically updated; and

•   describing links as “missing” also may be subject to interpretation because the criteria used to establish the noncancer disease links in SEM are not fully described in Haz-Map, from which the information is taken.

The committee sought to evaluate the scientific rigor of the links, without consideration of possible use of the links for compensation or other DEEOIC purposes. The committee recognized that such applications were beyond its scope. The links in Tables 3-2, 3-3, and 3-4 are for information purposes only and should not be considered as definitive for EEOICPA claims without further review (see Chapter 4).

Cancer Links

Table 3-2 shows 15 substances for which there are no cancer links in SEM. With the exception of trichloroethylene, which is classified by EPA as being carcinogenic to humans by EPA (EPA, 2011), all the other toxic substance—cancer links are based classified by IARC as Group 1, sufficient evidence of cancer in humans (Cogliano et al., 2011; IARC, 2012)—the only criterion that Haz-Map uses to designate a link between cancer and a toxic substance (www.haz-map.com). The committee relied on human data to identify substance-cancer links for this exercise because animal and mechanistic cancer data may not accurately reflect the potential cancer sites in humans.

Some cancer links are missing from SEM for unknown reasons. Although there are possible explanations for why some of the cancer links in Table 3-2 are not in the database, it is not apparent why the cancer links shown for arsenic and bladder cancer, asbestos and ovarian cancer, and hepatitis B virus and liver cancer are not in the database. The links are based on cancer sites that IARC identifies as having sufficient evidence of cancer in humans (Cogliano et al., 2011; IARC, 2012), and they meet the Haz-Map criterion of a toxic substance—cancer causal relationship. However, the cancer links are not in Haz-Map either, and unlike the cancer links for diesel exhaust and coal tar pitch volatiles discussed earlier, they are not scheduled to be added to Haz-Map in the future (www.haz-map.com). Additional, but unspecified, criteria or rationales, other than IARC classifications of sufficient evidence in humans appear to be used for some toxic substance—cancer links in SEM. DOL should provide a rationale for not adding the cancer

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
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TABLE 3-2 Selected Missing Links for Toxic Substance-Cancer Based on Sufficient Evidence of Cancer in Humansa

SEM Substance Cancer Site
Arsenic Urinary Bladder
Asbestos Ovary
1,3-Butadiene Hematolymphatic Organsb
Coal Tar Pitch Volatiles Lungc
Diesel Exhaust Lungd
Formaldehyde Leukemiad
Hepatitis B Virus Liver (hepatocellular carcinoma)
Iodine 131 Thyroid
Plutonium Bonee; Liver
Radium Boned; Mastoid Process; Paranasal Sinusd
Radon Lungd
Strontium 90 Leukemia; Solid Cancers
Thorium Bile Duct, extrahepatic; Gall Bladder; Leukemia (excluding chronic lymphocytic leukemia); Liver (including hemangiosarcoma)
o-Toluidine Urinary Bladderd
Trichloroethylene Kidneye

a Except as noted (see footnote d), identified by IARC as sufficient evidence of cancer in humans as described in Cogliano et al. (2011) and IARC (2011). IARC (2012) reclassified diesel exhaust as sufficient evidence of cancer in humans.

b Haz-Map identifies “Leukemia” and “Lymphoma, Non-Hodgkin” as the cancer sites linked to 1,3-butadiene.

c Scheduled to be added to Haz-Map at the end of 2012 (www.Haz-Map.com). Presumably will be added to SEM when the database is updated.

d Listed in Haz-Map. Presumably will be added to SEM when the database is updated.

e Identified by EPA as sufficient evidence of cancer in humans by all routes of exposure (EPA, 2011).

links shown in Table 3-2 for arsenic, asbestos, and hepatitis B virus to SEM so that it is transparent to SEM users.

The rationale for not including in SEM the trichloroethylene—kidney cancer link established by EPA may be due to the fact that trichloroethylene has not been identified as a Group 1 carcinogen by IARC (IARC, 1995).3 As a result, the trichloroethylene-cancer link does not meet the Haz-Map criterion for cancer causality. EPA classified trichloroethylene as carcinogenic in humans by all routes of exposure based on the results of a meta-analysis that included occupational

___________________________

3 In December 2012, a news item was published in the Lancet describing IARC’s recent reclassification of trichloroethylene as a Group 1 carcinogen with sufficient evidence of carcinogenicity in humans for kidney cancer (Guha et al., 2012).

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
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TABLE 3-3 Selected Missing Toxic Substance-Cancer Links Based on Limited Evidence in Humansa

SEM Substance IARC Group Cancer Site (IARC Group)
Arsenic 1 Kidney; Liver; Prostate
Asbestos 1 Colorectum; Pharynx; Stomach
Benzene 1 Multiple myeloma and Non-Hodgkin Lymphomab
Cadmium 1 Kidney; Prostate
Chloramphenicol 2A Leukemia
Chloramphenicol 2A Leukemia
Chlorodiphenyl
   (Polychlorinated Biphenyls)
1 Hepatobiliary Tract
Chromium VI 1 Nasal Cavity and Paranasal Sinus
Coal Tar Pitch Volatiles 1 Urinary Bladder
Cobalt Metal with
   Tungsten Carbide
2A Lung
Diesel Exhaust 1 Urinary Bladder
Ethylene Oxide 1 Breast; Non-Hodgkin Lymphoma and Multiple Myelomab
Formaldehyde 1 Nasal Cavity and Paranasal Sinus
Hepatitis B Virus 1 Liver (cholangiocarcinoma); non-Hodgkin lymphoma
Iodine-131 1 Bone and Soft Tissue; Digestive Tract; Leukemia; Salivary Gland
Lead 2A Stomach
Plutonium 1 Solid Tumors (other than bone, liver, and lung)
Radon 1 Leukemia
Radon 1 Leukemia
Styrene 2B Lymphatic and Hematopoietic Neoplasms
Sulfuric Acid 1 Lung
Tetrachloroethylene
(Perchloroethylene)
2A Cervix; Non-Hodgkin Lymphoma; Esophagus
Thorium 1 Pancreas; Prostate
Trichloroethylene 2A Non-Hodgkin Lymphomac; Liver and Biliary Tractc
Welding Fumes 2B Lung

a Identified by IARC as limited evidence of cancer in humans as described in Cogliano et al. (2011).

b IARC also identifies chronic lymphocytic leukemia and acute lymphocytic leukemia as being linked to benzene and ethylene oxide exposure based on limited evidence in humans. However, SEM lists “Leukemia,” which includes chronic lymphocytic leukemia and acute lymphocytic leukemia, as being linked to benzene and ethylene oxide, so it is not included in the table.

c Also identified by EPA (2011).

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
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TABLE 3-4 Selected Missing Toxic Substance-Noncancer Disease Links Based on Evaluations by Authoritative Organizationsa

SEM Substance Human Disease/Illness Authoritative Organization
Antimony Cardiovascular (deaths; increased blood pressure; EKG changes from occupational exposures) ACGIH, 2001; ATSDR, 1992; NIOSH, 1978
Carbon Disulfide Cardiovascular (increase in mortality due to ischemic heart disease in several occupational studies) Cal/EPA, 2002
Carbon Monoxide Cardiovascular (workers at significantly increased risk of death from atherosclerotic disease; deaths of workers with existing cardiovascular disease) ACGIH, 2001; Cal/EPA, 1999
Chromium VI Male Reproduction (infertility, decreased fecundability, other effects in exposed workers) Cal/EPA, 2009
Dibutyl Phthalate Male Reproduction (decreased testosterone levels in occupationally exposed men) Cal/EPA, 2007
2,4- and 2,6-Dinitrotoluene Cardiovascular (significant increase in heart disease mortality in occupational cohort study) ACGIH, 2001; ATSDR, 1998
Hydrogen Cyanide Central Nervous System Endocrine System (nervous system effects and thyroid enlargement in workers chronically exposed to low levels) ACGIH, 2001; Cal/EPA, 2000
Methylene Chloride (Dichloromethane) Cardiovascular (OSHA standard based in part on protecting against effects on the heart) Cal/EPA, 1999; DOL, 1997
Rotenone Peripheral Nervous System (a few reported cases of peripheral neuropathy) EPA, 2007b
Tetrachloroethylene (Perchloroethylene) Central Nervous System (visual changes, increased reaction time, decrements in cognition from low level occupational exposures) EPA, 2012; NRC, 2010
Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
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SEM Substance Human Disease/Illness Authoritative Organization
Toluene Central Nervous System (altered color vision; decreased performance in neurobehavioral tests from low level occupational exposures) EPA, 2005b
Welding Fumes Metal Fume Feverb DOL, 1989; IARC, 1990; NIOSH, 1988

a The process the committee used to identify the toxic substance—disease links and the definition of authoritative organizations are provided in the text.

b Based on the complex mixture. Metal fume fever is also listed in SEM; however, it is listed as a potential disease link based on one of the 43 chemical constituents of welding fumes.

NOTE: EKG = electrocardiogram; OSHA = Occupational Safety and Health Administration.

epidemiological studies (EPA, 2011). EPA’s criteria for “carcinogenic in humans” (EPA, 2005a) are not substantially different from IARC’s criteria for “sufficient evidence of cancer in humans” (IARC, 2006). Since the IARC evaluation was published in 1995, IARC’s classification of trichloroethylene as a Group 2A or probable carcinogen does not take into account the more recent cancer evidence for trichloroethylene in the EPA meta-analysis. From a scientific perspective, the committee does not believe that the omission of the trichloroethylene-kidney cancer link from SEM is valid.

Some of the links in Table 3-2 (formaldehyde and leukemia, o-toluidine and bladder cancer, 1,3-butadiene and cancer of the hematolymphatic organs) are in Haz-Map but not in SEM presumably due to a time lag in importing the Haz-Map links into SEM (i.e., the links are currently in the former, but have not yet been added to the latter). This is described further in the section on updating SEM.

Additionally, the lung cancer links for diesel exhaust and coal tar pitch volatiles presumably also will be added to SEM, although the links are not in Haz-Map. As a part of the revisions to Haz-Map, based on the 2012 IARC cancer evaluation (Cogliano et al., 2011; IARC, 2012), the lung cancer links for diesel exhaust and coal tar pitch volatiles are scheduled to be added to it by the end of 2012 (http://www.haz-map.com/cancer.htm). DOL has also concluded that the diesel exhaust cancer link could be verified and would be added to SEM (http://www.sem.dol.gov/StatusD.cfm).

SEM does not include links between radioactive substances and cancers. The reason for not including cancer links for the six radioactive substances (iodide-131, plutonium, radium, radon, strontium-90, and thorium) in Table 3-2 is not clear. It may be because DOL does not evaluate claims involving radiation and cancer under Part E. Radiogenic cancers, including thyroid, bone, liver, lung, leukemia, and gall bladder cancers, are covered under Part B which does not use

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
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SEM. According to the SEM website, SEM does not address the relationship between radiation and cancer. For purposes of EEOICP, the relationship between radiation and cancer is evaluated by the NIOSH (http://www.sem.dol.gov). However, if this is the reason, it does not appear to be consistent with information in the SEM profiles for the substances. They state that “no diseases were listed in NLM Haz-Map (i.e., NLM had not identified any occupational disease related to exposure to this substance) as of June 5, 2012.” The statement, which is used generically in the database when there is no disease information, implies that if or when disease information for the radioactive substances is added to Haz-Map, it will be subsequently added to SEM. The committee found this generic language misleading for radioactive substances.

Regardless of SEM’s inclusion or exclusion of radiogenic cancers, the committee found discrepancies in the cancers linked to radioactive substances in the Haz-Map and SEM databases. As shown in Table 3-2, cancer links for plutonium, radon, and radium are currently in Haz-Map. Since some information for these substances is listed in SEM, it is not clear if the Haz-Map cancer links eventually will be added to SEM. Currently, Haz-Map does not have links for iodine-131 and thyroid cancer; plutonium and liver cancer; strontium and leukemia and solid cancers; thorium and bile duct, gall bladder, or leukemia; and radium and the mastoid process (see Table 3-2). It is unclear if they will be added to Haz-Map (and eventually to SEM), even though they are IARC Group 1 carcinogens. These cancer links are not scheduled to be added to Haz-Map, although they are in the 2012 IARC cancer monograph (http://www.haz-map.com/cancer.htm). The DOL notation of “could not be verified” (http://www.sem.dol.gov/StatusD.cfm) for the publicly submitted link between iodine-131 and thyroid cancer suggests that the cancer link will not be added to SEM. It also suggests that additional criteria (other than the IARC designation of sufficient evidence of cancer in humans) are used to identify cancer links for radioactive substances. Given these inconsistencies and the lack of transparency, DOL should clarify whether Haz-Map cancer links for radioactive substances are included in specific SEM substance profiles. If the cancer links are included in SEM, DOL should provide the complete criteria that are used to identify which cancer links are imported into the database.

To assess how criteria for substance—disease links may affect SEM, the committee looked for cancers associated with substances in SEM using a less strict criterion than the IARC Group 1 classification currently used by Haz-Map. Table 3-3 shows cancer links for 23 substances that are not in SEM because the epidemiological studies on which the links are based are classified by IARC as “limited” evidence of cancer in humans (Group 2) rather than “sufficient” (Cogliano et al., 2011; IARC, 2012). As a result, the links do not meet the Haz-Map criteria for cancer causality and are not included in either Haz-Map or SEM. The toxic substance—cancer links include 11 cancers—prostate, colorectum, pharynx, multiple myeloma, breast, digestive tract, salivary gland, hepatobiliary tract, cervix, esophagus, and pancreas—that were not listed in Haz-Map.

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
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Deciding whether only the IARC classification of sufficient evidence of cancer in humans or whether the IARC classifications of both sufficient and limited evidence of cancer in humans most appropriately reflect the intent of EEOICPA is a DOL policy decision on the application of scientific information, not a scientific decision.

Noncancer Links

Table 3-4 shows 13 substances for which noncancer disease links are not in SEM. Diseases or health effects identified include cardiovascular, male reproductive, central and peripheral nervous system, and endocrine effects. All of the disease links are based on human case reports or epidemiological studies. As a result, according to the limited information available in Haz-Map, the links appear to be consistent with its criteria for determining noncancer disease causality. Regarding noncancer disease links, Haz-Map states that “for chronic diseases, linkage between an agent and a disease means that a causal relationship has been determined based on human case reports or epidemiological studies” (www.haz-map.com; accessed January 22, 2013).

Some authoritative organizations, for example, OSHA and EPA, also use disease or health effect endpoints to derive exposure limits for regulatory or preventative purposes. Such use indicates that the toxic substance—disease associations are strong, and that the disease is the most sensitive health endpoint for the toxic substance. EPA and Cal/EPA prioritize human studies of sufficient quality over animal studies (EPA, 2002). The diseases in Table 3-4 are all based on occupational health studies.

Effects on the cardiovascular system resulting from occupational exposures were identified as the most sensitive health endpoint and are the basis for the NIOSH recommended exposure limit for antimony (NIOSH, 1978), the Cal/EPA acute reference exposure level for carbon monoxide (Cal/EPA, 1999), and the Cal/EPA chronic noncancer reference exposure level for methylene chloride (Cal/EPA, 1999) (see Table 3-4). Cardiovascular effects are also the basis for the OSHA methylene chloride standard, due to metabolism of methylene chloride to carboxyhemoglobin (DOL, 1997). The OSHA standard includes medical surveillance requirements that are intended to provide specific protections for workers with existing cardiovascular disease. As of October 1, 2012, however, cardiovascular disease is not included in Haz-Map as an occupational disease, and is listed in the “More Research Needed” category (http://hazmap.nlm.nih.gov). The criteria used to determine whether cardiovascular disease is an occupational disease and the basis for adding toxic substance—cardiovascular links to SEM, are not clear in Haz-Map. To ensure transparency, these criteria should be made available to SEM users.

Chronic central nervous system (CNS) effects are linked to tetrachloroethylene and toluene (see Table 3-4) on the basis of chronic low-level, occupational

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
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exposures resulting in such effects such as visual deficits (EPA, 2012). These CNS effects are different from “encephalopathy, chronic solvent,” which is found in both Haz-Map and SEM databases, and is caused by chronic high exposures to solvents. This health effect is listed for all organic solvents used in paints and varnishes in both databases (www.haz-map.com/overview.htm; accessed January 22, 2013). These CNS effects at low exposures are the basis for EPA’s reference concentrations for tetrachloroethylene (EPA, 2011) and toluene (EPA, 2005b), but neither are in either database. Since the EPA IRIS database is one of the information sources Haz-Map identifies in its references, it is not clear why the disease links for tetrachloroethylene and toluene are not in Haz-Map or SEM.

Male reproductive effects have been associated with chromium VI and dibutyl phthalate (Cal/EPA, 2007, 2009) but these associations are not listed in either the SEM or Haz-Map. Furthermore, neither database has a chemical profile for chromium VI alone, but rather include it with other forms of chromium in a profile for “Chromium and Chromium Compounds.” The Haz-Map profile for chromium and compounds is a mix of data pertaining to chromium III, a relatively benign compound and essential nutrient, and chromium VI, a highly-toxic substance known to cause lung cancer (ATSDR, 2012b). Because the toxicity of chromium III and chromium VI differ substantially, the distinction between the two chemicals should be made clear in both databases. A further complication is that the CAS (or Chemical Astract Service) registry number used for chromium and chromium compounds in both databases is 7440-47-3, the number usually associated with chromium metal. The CAS number used typically for chromium VI is 18540-29-9. However, the occupational diseases listed for the CAS number 7440-47-3 are specific to chromium IV (ATSDR, 2012b), which is included in chromium compounds in both databases. This method of combining substance profiles may lead to inaccurate conclusions; in this case, that chromium III causes lung cancer. Despite this flaw, the substance—disease links for chromium and compounds (if interpreted as being chromium VI) are correct except for the lack of male reproductive effects. In cases where the effects of a specific form of a compound differ greatly from the group of compounds, a separate profile or distinct notation should reflect the differences in toxicity among them.

The link between welding fumes and metal fume fever is captured in SEM, but it is missing in the Haz-Map database. This is because SEM lists toxic substance—disease links for the constituents of mixtures as opposed to the mixture as a whole. Metal fume fever can result from exposure to welding fumes (DOL, 1989; IARC, 1990; NIOSH, 1988) and should be captured in SEM. However, this link in SEM is based on the diseases associated with the two of the constituents of welding fumes, zinc and copper, both of which are linked to metal fume fever in Haz-Map. In Haz-Map, welding fumes are linked to toxic pneumonitis and chronic obstructive pulmonary disease.

In summary, the committee determined that there are missing links between substances potentially present at DOE sites and cancers and noncancer diseases in

Suggested Citation:"3 Site Exposure Matrix Dat." Institute of Medicine. 2013. Review of the Department of Labor's Site Exposure Matrix Database. Washington, DC: The National Academies Press. doi: 10.17226/18266.
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SEM as of October 1, 2012. Links may be missing due to human error, ambiguous criteria for establishing links in Haz-Map, lack of consistency between the “Diseases” field in Haz-Map and the “Specific Health Effects” field in SEM, or because of delays in updating both databases.

SUMMARY

SEM provides a key function in the EEOICPA Part E compensation system and is one tool by which claims examiners assess whether occupational exposure to a toxic substance at a DOE facility is associated with an occupational disease. In its evaluation of this database, the committee identified several strengths, including its development with consultation from DOE experts and former workers and its attempt to comprehensively list all toxic substances used at DOE facilities. However, the committee also identified several major weaknesses in SEM, specifically the difficulty in accessing some information in the database, lack of detailed exposure information; inability to handle complex exposures, including exposure to mixtures, chemical compounds, and radioactive substances; ambiguity in why certain links are not listed; incomplete or inconsistent exposure profiles based on location and job; disregard of epidemiologic studies in DOE workers; and the sole use of Haz-Map for substance—disease links.

In particular, the sole use of Haz-Map for disease causation was problematic for several reasons, and the committee conducted an exercise that illustrated examples of toxic substance—disease links that are not currently in SEM. The exercise was extensive, but not comprehensive. However, based on it, the committee identified cancer links that are missing in SEM that have been categorized by IARC as having sufficient evidence in humans (see Table 3-2) or limited evidence in humans (see Table 3-3), as well as missing links in the database for noncancer diseases based on evaluations by other authoritative organizations (see Table 3-4). The exercise also identified noncancer disease links that are missing from SEM. Overall, the committee noted that links may be missing due to human error, ambiguous criteria for determining or excluding links in Haz-Map, lack of exposure information in SEM, or because of delays in updating links in both databases. To address the weaknesses in SEM, and particularly to strengthen the toxic substance—disease links in SEM, the committee proposes a number of recommendations to DOL. These recommendations are discussed in detail in the next chapter.

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Beginning with the development of the atomic bomb during World War II, the United States continued to build nuclear weapons throughout the Cold War. Thousands of people mined and milled uranium, conducted research on nuclear warfare, or worked in nuclear munitions factories around the country from the 1940s through the 1980s. Such work continues today, albeit to a smaller extent. The Department of Energy (DOE) is now responsible for overseeing those sites and facilities, many of which were, and continue to be, run by government contractors. The materials used at those sites were varied and ranged from the benign to the toxic and highly radioactive. Workers at DOE facilities often did not know the identity of the materials with which they worked and often were unaware of health risks related to their use. In many instances, the work was considered top secret, and employees were cautioned not to reveal any work-related information to family or others. Workers could be exposed to both radioactive and nonradioactive toxic substances for weeks or even years. Consequently, some of the workers have developed health problems and continue to have concerns about potential health effects of their exposures to occupational hazards during their employment in the nuclear weapons industry.

In response to the concerns expressed by workers and their representatives, DOL asked the Institute of Medicine (IOM) to review the SEM database and its use of a particular database, Haz-Map, as the source of its toxic substance-occupational disease links. Accordingly, this IOM consensus report reflects careful consideration of its charge by the committee, and describes the strengths and shortcomings of both. To complete its task, IOM formed an ad hoc committee of experts in occupational medicine, toxicology, epidemiology, industrial hygiene, public health, and biostatistics to conduct an 18-month study to review the scientific rigor of the SEM database. The committee held two public meetings at which it heard from DOL Division of Energy Employee Occupational Illness Compensation (DEEOIC) representatives, the DOL contractor that developed the SEM database, the developer of the Haz-Map database, DOE worker advocacy groups, and several individual workers. The committee also submitted written questions to DOL to seek clarification of specific issues and received written responses from DEEOIC. The committee's report considers both the strengths and weaknesses of the SEM and the Haz-Map databases, recognizing that the latter was developed first and for a different purpose. The committee then discusses its findings and recommends improvements that could be made in both databases with a focus on enhancing the usability of SEM for both DOL claims examiners and for former DOE workers and their representatives. Review of the Department of Labor's Site Exposure Matrix Database summarizes the committee's findings.

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