Regulatory Stakeholders

The interaction between citizen stakeholders and regulatory stakeholders is unique. Since the 1960s, environmental laws have created a role for the public in the development of regulatory requirements, particularly if they relate to human health and safety. Thus, virtually every federal and state statute requires public notice and public comment. Some statutes, such as Superfund, require that regulatory agencies consider community opinion (42 U.S.C. 9621, Section 21). 

Tanzania, which investigated supply chains from local producers and importers into the health sector. Qualitative interviews and quantitative data collection on availability, somce and price of a checklist of tracer medicines and other essential supplies were conducted in hoth countries. In Tanzania, 42 health facilities (public, faith-based and private), pharmacies and drug shops across four very diverse districts were visited (Tibandebage et al., 2014), while in Kenya, 55 health facilities, pharmacies and shops were interviewed in a comparative study (Kariuki et al., 2015). Following these supply chain studies, wholesalers, manufacturers and poUcy and regulatory stakeholders were interviewed in both countries in 2013-14. This chapter draws also on some of these interviews, alongside secondary data somces. 

Stakeholder is a person or group that has a legitimate interest in the facility. For a facility handling hazardous chemicals, examples could be employees, neighbors, the board of directors, shareholders, and the regulatory community. 

The European Commission (EC) has sponsored four reports that evaluate a set of 553 substances selected by experts and stakeholders for assessment for endocrine disruption. Each report addresses a subset of the total set based on priorities such as whether the chemicals are persistent, bioaccumulating or High Production Volume chemicals and/or whether or not there is already regulatory control of the chemical. 

Excellence is exceeding the minimum regulatory framework in which the organization operates and to strive to understand and respond to the expectations of their stakeholders in society. 

Established Practices Codes, standards, regulatory requirements, industry guidelines, recommended practices, and supplier specifications have all developed over the years to embody the collective experience of industry and its stakeholders in the safe handling of specific materials. These should be the engineer s first resource in seeking to design a new facility. 

An important part of the risk management process involves informing consumers, industry and other stakeholders of the decisions made by regulatory authorities. However, this is a narrow view of risk communication that does not take into account the potential for dialogue between interested parties that can result in better decision-making. Understanding how consumers view the potential risks associated with food additives can help to avoid either under- or over-regulation. 

The development process starts with a thorough planning step in which a development plan is generated by the collaboration of all stakeholders, such as quality assurance (QA), QC sourcing sites, stability, development, and regulatory functions. Planning should also include information gathering to obtain ... 

Recommendation 5. The Army should proceed as soon as possible to develop means to address secondary waste processing/disposal issues at sites employing disposal technologies other than incineration, and should seek early regulatory and stakeholder approval for such means. 

These problems cause delays in regulatory decision making, which have significant implications for all the stakeholders. 

Risk assessors and decision makers both need to be prepared to communicate risk results in an understandable form to other practitioners (regulatory and registrant), stakeholders, and the public. This is particularly critical in the case of uncertainty in the assessment. Most scientists hired to perform risk assessment are thoroughly trained in their subject matter but less familiar with the demands of public presentation or the essentials of educating at multiple levels. Regulators must provide scientists and decision makers with the support and opportunity to develop skills necessary to effectively communicate with stakeholders and the public. 

Outcomes of in vitro methods or simple in vivo methods such as the PLNA, only indicate whether a compound can sensitize the immune system. They do not predict whether a compound can induce an autoimmune disease. For that disease models are warranted. However, most disease models, as mentioned, will often require predisposed animal strains such as systemic lupus erythematosus (SLE)-prone mice [81, 82]. Often models using autoimmune-prone mice or rats (including the BN rat) are considered too sensitive and are for that reason undesired by various stakeholders (i.e., pharmaceutical industries, regulatory agencies). 

This book provides an insider s perspective of the status of the fine-chemical industry, as well as its outlook. It covers all aspects of this dynamic industry, with all of its stakeholders in mind, viz. employees, customers, suppliers, investors, students and educators, media representatives, neighboring communities, public officials, and anyone else who has an interest in industrial context. Safety, health, environmental, and regulatory issues are discussed only briefly, as the related subjects are extensively covered in the specialized literature. 

---