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they exhibit low inherent hazard and none have been identified as causing unique workplace exposure concerns.

      EPA's stated reasons for wanting the exposure data was to ensure they could adequately address risks to prospective parents. The data would demonstrate to EPA that the exposures (and corresponding risks) are low, thereby eliminating the need to consider the need for a two generation reproductive study. These studies are costly (frequently $1 million or more) and raise animal welfare issues. There is no guarantee that if these data are collected, EPA will not require such a study, but all the options would be reviewed more rationally.

      3.13.2.2 The Solution

      In response to EPA concerns regarding workplace exposures, the sponsoring companies gathered IH to develop a sampling and analytical strategy for these alkanes. Working with a certified Industrial Hygiene Laboratory the analytical method and sampling strategy was agreed to. The companies did workplace exposure monitoring and collected the data for a joint submittal to EPA. Monitoring results showed exposures to be below 0.2 ppm.

      After reviewing the data EPA was satisfied that there was no additional information needed to demonstrate low exposure potential and no additional toxicity testing was requested.

      This result demonstrates the value of exposure assessment and IH involvement in “voluntary” agency‐sponsored PS initiatives. Information on VCCEP and this example can be found on the USEPA website at https://chemview.epa.gov/chemview.

      3.14 History of Product Stewardship

      To understand what an IH is one can start by reviewing some accepted definitions of the IH profession. The following definitions/descriptions of Industrial Hygiene are offered merely as examples of the many that can be found. Each can add a little insight into the knowledge, motivations, duties, and competencies shared by those who practice IH.

      Probably the single most quoted (or paraphrased) definition of IH is

      The Anticipation, Recognition, Evaluation, and Control of Workplace Health Hazards.

      This short description not only implies the overarching mission of IH but also outlines what could be considered as the four distinct stages of comprehensive IH practice.

      The American Industrial Hygiene Association (AIHA), the largest global membership organization for IHs, defines Industrial Hygiene as the

      Science and art devoted to the anticipation, recognition, evaluation, prevention, and control of those environmental factors or stresses arising in or from the workplace which may cause sickness, impaired health and well‐being, or significant discomfort among workers or among citizens of the community.

      Correspondingly, the AIHA defines IHs as

      Scientists and engineers committed to protecting the health and safety of people in the workplace and the community.

      The American Board of Industrial Hygiene (ABIH), the largest global IH Certification Organization, describes the scope of technical knowledge assessed in their certification process as follows:

       Basic Sciences Occupational disease, illness, injury, and surveillance (biostatistics, epidemiology, toxicology);

       Health Hazards Ergonomics/human factors, physical stressors, biological stressors, chemical stressors;

       Work Environments Indoor air, industrial processes;

       Program Management Principles Investigation methods, ethics, risk communication, guidelines and standards, data management and integration, emergency response;

       Evaluation Practices Instrumentation, sampling methods/techniques, analytical chemistry;

       Hazard Controls Engineering, PPE, administrative; and

       Community Stressors Air pollution, hazardous waste.

      The above definitions/descriptions, along with the learnings of many years of diverse experience, help support certain generalizations applicable to the profession of Industrial Hygiene:

       IH is science‐based and diverse in nature; IH practitioners must therefore be technically aware across a broad range of disciplines including chemical, physical, biological, and other emerging or special scientific categories.

       the process of anticipation, recognition, evaluation, prevention, and control, the fundamental of the practice of IH, is not specific to any single environment or issue; the process can be successful in virtually any form of problem solving.

       the practice of IH usually includes at least some emphasis in each of the major areas of Health, Safety and Environmental specialty.

       the core mission of IH is not limited to the welfare of a facility' workers or those in the immediate neighborhood; rather it should play a role in improving the health of all peoples and environments affected by commercial activities.

       the HSE objectives of IH are not just achieved via the traditional facility‐based approach, but also through strategies linked to product life cycles, transportation or other paradigms.

       while the IH profession is not driven by regulation, IH practitioners clearly strive to have a working knowledge of all regulations, laws, and standards applicable to the scope of their current and anticipated work.

      The profession of IH, as summarized above, clearly leaves opportunity for practitioners from different backgrounds with different areas of specialization. For example, some IHs ultimately focus on certain stages of the process (i.e. control versus recognition), some on specific scientific rubrics (i.e. physical versus chemical hazards), and still others on management versus field work, and so on. Yet based on the general nature of IH practice and the common requirements to practice IH, certain generic competencies are very likely to be shared by most IH professionals. These competencies/abilities would include

      1 a broad understanding of the scientific process, with specific expertise in one (and usually more) aspects of the health sciences.

      2 a general understanding of HSE regulatory and standard setting processes, with more complete knowledge of certain specific regulations, laws and standards, and experience working with respective agencies/institutes.

      3 HSE risk assessment skills; moreover, the learned ability to coalesce data and circumstances into potential risk, make comparisons to acceptable levels and suggest prudent action.

      4 an ability to make responsible estimates when facts, data, and circumstances are not well known.

      5 an appreciation for the interrelationships of

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