CANCER, REPRODUCTIVE, AND CARDIOVASCULAR DISEASES
Outcomes are events, occurrences, or conditions that indicate progress in achieving the purpose of the program. Outcomes reflect the results of a program activity compared with its intended purpose, or outcomes may answer the question, "Will these resources result in success or contribute to the success of what we want to accomplish?"
Outcomes can be viewed from two different perspectives—ultimate and intermediate. For an occupational safety and health research program like the NIOSH Cancer, Reproductive, and Cardiovascular Diseases Program, ultimate outcomes are reductions in a particular type of worker illness or adverse reproductive event. These health outcomes have complex causes, and any effect of program activities on rates can take years to be seen. Therefore, outcomes are often measured on an intermediate timeframe. Intermediate outcomes are necessary steps that lead to ultimate outcomes—for example, reductions in the risk of a particular type of injury or illness. For occupational safety and health research programs, achieving intermediate risk reductions is as important as achieving the ultimate outcome of decreasing injury and illness incidence rates.
Although demonstrating ultimate outcomes for the CRC is difficult, provision of research findings that will be influential in the refinement of State, Federal, and international radiation exposure standards have resulted in intermediate outcomes that would be expected to contribute toward the desired end outcomes—reduced incidence of occupational cancer. These findings are transferred via peer-reviewed publications, direct communications with workers and worker representatives, and presentations (see above). Among the customers for CRC research are OSHA and IARC.
OSHA is mandated to regulate occupational safety and health in the United States. OSHA does this in part by creating OSHA Standards, which are regulations addressing occupational safety and health set forth in title 29 of the Code of Federal Regulations (CFR)—these regulations may be substance specific or may cover a broader topic. Most of the studies that have gained prominence for NIOSH in occupational cancer epidemiology and have had significant regulatory impact were initiated prior to 1985 (uranium miners, beryllium, ethylene oxide, formaldehyde, and cadmium). OSHA has not frequently issued new substance-specific standards in the past 10 years—among the more recent OSHA standards is the OSHA Cadmium standard (29 CFR 1910.1027), the provisions of which became effective as of December 11, 1992. CRC data concerning cadmium as an occupational carcinogen were used by OSHA in the creation of the cadmium standard.1 Specifically, in the preamble to Final Rule for the OSHA Cadmium Standard, Section 5-V. Health Effects, Section 8, Studies of the U.S. Cadmium Smelter Cohort (Globe), OSHA reports in detail on NIOSH CRC data used to support the OSHA Standard.2, 3 The CRC data included estimates of cadmium exposures and an evaluation of the mortality experience of workers in the cohort by standardized mortality ratios per dose group. An excess of lung cancer mortality was observed in relation to cadmium exposure.
Another organization that has an impact on safety and health for workers around the world is the International Agency for Research on Cancer (IARC). IARC categorizes substances or exposure conditions relative to the available evidence concerning their potential carcinogenicity, through its monographs program (http://monographs.iarc.fr/). IARC’s designation of agents as Group 1 (having sufficient evidence of carcinogenicity in humans) or Group 2 (possibly or probably carcinogenic to humans) is used worldwide to provide evidence to reduce workplace exposure to carcinogens.
In March 2009, IARC convened a group of experts to re-evaluate the carcinogenicity of all Group 1 metals, particles and fibers. The purpose of the re-evaluation was to update the evidence base for these substances and to clearly identify the types of cancer caused by these agents. The metals evaluated were arsenic, beryllium, cadmium, chromium(VI) and nickel compounds. The particles evaluated were leather dust (replacing “boot and shoe manufacturing”), wood dust and crystalline silica, and the fibers evaluated were asbestos and erionite (a compacted volcanic ash present in certain parts of the world). As a result, all ten agents were reaffirmed as known human carcinogens. All six commercial forms of asbestos (chrysotile, crocidolite, amosite, tremolite, actinolite and anthophyllite) are now considered to be a cause of cancers of lung, mesothelium, larynx, and ovary. Talc and vermiculite that contain asbestos were also identified as Group 1 carcinogens. NIOSH CRC studies were very influential in the evaluation of beryllium, crystalline silica, asbestos, and chromium(VI). The results of this review by IARC, and the specific types of cancers caused by these substances, are summarized in a recent article4 and will be described in more detail in an IARC monograph. IARC will also be re-evaluating chemicals and forms of radiation that have been designated as Group 1 carcinogens in upcoming meetings.
In past IARC categorizations, CRC studies contributed to the categorization of 22 (63%) of the 35 industrial agents categorized by IARC as Group 1 and to 15 (45%) of the 33 industrial and agricultural agents listed in IARC Group 2A (probably carcinogenic to humans).5 NIOSH has conducted studies on 17 industrial agents listed in IARC Group 2B (possibly carcinogenic to humans). Among the more recent studies from CRC used by IARC include those involving certain aromatic amines. CRC laboratory research on 4,4’ methylene bis-2-chloroaniline (MOCA) found binding of MOCA to hemoglobin and DNA in animals, with five different adducts found in rat liver. Two of the five adducts were found in exfoliated cells from a worker. A CRC bladder cancer incidence study among workers exposed to MOCA found three workers with bladder cancer. CRC research on ortho-toluidine found a 6.5 fold risk of bladder cancer among workers exposed to ortho-toluidine in a chemical manufacturing plant. CRC research also led to the identification of ortho-toluidine-hemoglobin adducts in exposed workers. Based in part on this CRC research, IARC recently changed its classification of both MOCA and ortho-toluidine to Group 1 human carcinogens.6 Furthermore, CRC research on genetic susceptibility among benzidine-exposed workers contributed to reaffirm the carcinogenicity of benzidine in humans (Group 1).7
Other Intermediate Outcomes
A variety of other intermediate outcomes have resulted from CRC research. For example:
- The U.S. Air Force instituted new personal protective clothing for those exposed to JP-8 jet fuel (a mixture of hydrocarbons formulated with the anti-icing agent, 2-(2-methoxyethoxy)ethanol (a toxic glycol ether)) in part based on CRC research that found excessive exposures to fuel among workers working with the fuel.
- Some antineoplastic drugs are human carcinogens. A report was filed via MedWatch (the Food and Drug Administration [FDA] program for voluntarily reporting product problems and adverse events) after CRC research showed that the outside of antineoplastic drug vials were contaminated with the drug product.8 This research contributed to an FDA ruling to change practices at manufacturing facilities.
- Exposure of workers to components of methamphetamine production during law enforcement, first response, and decontamination activities at illicit drug laboratories is a growing problem. Among the health problems that could result from such exposure are cardiovascular problems. NIOSH researchers have created new technology for detecting methamphetamines, which has been adapted into a field portable kit for use in assessing these exposures. The technology has been licensed to SKC, Inc. which is marketing the kit; 9 sales of the kit have been strong to industrial hygiene professionals involved in this type of work.10
- As a result of NIOSH CRC research, which found that pressure on the perineum (the area behind the scrotum) from prolonged bicycling was linked with a decrease in a measure of erectile function among a group of police bicycle-patrol officers, the City of San Antonio now offers no-nose saddle as an option for its bicycle police officers.11, 12
- Comments of the NIOSH on the OSHA proposed rule on occupational exposure to cadmium, 29 CFR Part 1910, Docket # H-057a, May 7, 1990.
- Cancer mortality among cadmium production workers. Ann NY Acad Sci 1976; 271:273-279.
- Mortality among a cohort of U.S.cadmium production workers— an update. JNCI 1985; 74:325-333.
- A review of human carcinogens—Part C: metals, arsenic, dusts, and fibres. Lancet Oncology 10(5):453-454, 2009.
- Before the President’s Cancer Panel.January 31, 1994, available as pdf.
- Carcinogenicity of some aromatic amines, organic dyes, and related exposures. Lancet Oncol 2008; 9:322-3.
- NAT2 slow acetylation and bladder cancer in workers exposed to benzidine. Int J Cancer 2006; 118:161-8.
- Surface contamination of chemotherapy drug vials and evaluation of new vial-cleaning techniques: Results of three studies. Am J Health-System Pharmacy 2005; 62 (5): 475-484.
- Personal communication between Eric Esswein and representatives of SKC, Inc.
- NIOSH Update: Prolonged riding linked to decrease in erectile measure in bicycle patrol officers. 2002, available at: http://www.cdc.gov/niosh/bikeOfficer.html
- NIOSH Update: Bicycle saddles without protruding noses reduce pressure associated with erectile dysfunction measure, study finds. 2004, available at: http://www.cdc.gov/niosh/updates/upd-06-30-04-2.html
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