Core Competencies. for the Product Stewardship Professional.

Transcription

1 Core Competencies for the Product Stewardship Professional

2 Index Contributors...3 Definition of Product Stewardship...4 Profile of the Product Stewardship Professional...5 Employment Profile...6 Organizational Structure & Roles...7 Core Competencies Overview...7 Technical Core Competencies...8 Basic Science...8 Manufacturing / Engineering Principles...8 Toxicology...8 Environmental Chemistry & Ecotoxicology...8 Safety Data Sheet (SDS) and Label Authoring...8 Exposure Assessment and Control...9 Risk Assessment...9 Sustainability...9 Product Safety Testing...9 Inherent Safe Product Design / Development...9 Regulatory Core Competencies...10 Chemical Hazard Communication National Chemicals Management Laws / Regulations Consumer Products Regulations Cosmetic / Personal Care Products Regulations Food Packaging / Food Contact Laws / Regulations Pesticides / Biocides / Plant Protection Products Regulations Sector of Use Regulations & Expectations Dangerous Goods Transportation Regulations Banned / Restricted Substances Regulations Professional Core Competencies...12 Individual Effectiveness Teamwork Management Business Acumen References Core Competencies for the Product Stewardship Professional 2

3 Contributors This document was prepared by the Product Stewardship Society Advisory Committee and Board members with support from the American Industrial Hygiene Association (AIHA ) and the listed AIHA staff: Allan Fleeger, CIH, CSP * Global Product Stewardship & Regulatory Affairs Manager ExxonMobil Corporation [email protected] Tom Grumbles, CIH * Product Safety Manager US Mega Projects Sasol North America, Inc. [email protected] Melanie Bausen Global Head Stewardship Governance BASF [email protected] Steve Benoit Global Product Stewardship Competency Leader DuPont [email protected] Erica Stewart, CIH EH&S Principal Consultant Kaiser Permanente [email protected] Jeff Hogue, CIH, REA Senior Director of Sustainability McDonalds Corporation [email protected] Sandra G. Wollschlager 3M [email protected] Steven Lacey, PhD, CIH, CSP * Associate Professor & Chair, Environmental Health Science Indiana University Fairbanks School of Public Health [email protected] James Romine * Vice President, Product Stewardship & Regulatory Affairs DuPont [email protected] Mark Herwig * Leader, Global Chemical Compliance & Risk Management Program GE [email protected] Vicky Yobp, CAE Managing Director, Professional Community AIHA [email protected] Molly Coskran, CIH ** Principal Heed Environmental Health, LLC [email protected] John Mikan, CIH (Consultant/ Primary Author) President/Principal Consultant Experien Health Sciences, Inc. [email protected] Barbara Dawson, CIH, CSP Global Occupational Health Competency Leader DuPont [email protected] Kathy Murphy, CIH Corporate Mgr, Product Stewardship, Training and Mgt Systems Honeywell [email protected] Donna Doganiero, CIH Director, Occupational Health Sciences Portfolio Army Institute of Public Health [email protected] Deb Martin, MS, CIH ** Sr. EHS Manager Pacific Biosciences [email protected] Marie Capdevielle, PhD, DABT * WW Director, Product Sustainability & Occ.Health Colgate-Palmolive [email protected] Nancy Liaboe, CMQ/OE, CIH, CSP * Director, Product Stewardship & Regulatory Affairs Abbott-Laboratories [email protected] Kate Sellers, PE * Associate Vice President / Principal Environmental Eng. ARCADIS U.S., Inc [email protected] Jodi Visco * Manager, Product Stewardship and Sustainability BASF [email protected] Adam Seery, CAE Manager, Member Services AIHA [email protected] *Product Stewardship Society Board member. **Stewardship & Sustainability Committee liaison. Core Competencies for the Product Stewardship Professional 3

4 Definition of Product Stewardship Product Stewardship (PS) is an emerging and evolving profession that currently lacks a globally-accepted formal definition. Practitioners in one industry can have very different views about the scope of PS than those from another industry, as can practitioners from non-governmental organizations (NGOs), academia, or government agencies. Because the Product Stewardship Society supports professionals from all of these employment sectors, the following broad definition is used for purposes of this document: Responsibly managing the health, safety, and environmental aspects of raw materials, intermediate, and consumer products throughout their life cycle and across the value chain in order to prevent or minimize negative impacts and maximize value. Intentionally absent from this definition are specifics regarding the types of products to be taken into account, which aspects of health, safety, and environment (HSE) are to be addressed, and whether or not socio-economic factors are to be considered. Clearly these are all extremely important considerations that should not be ignored, but a broad definition of PS enables the focus of this document to be on the lifecycle and HSE aspects of the minerals, metals, chemicals, and formulated chemical products that are the materials used to make other products. This relationship can be depicted as follows: Minerals, Metals Chemicals & Formulated Chemical Products Consumer Goods Medical Devices Automotive Components Aerospace Components Industrial Equipment Medical Equipment Pulp & Paper Products Agricultural Products Food Products / Packaging Nutritional Supplements Pharmaceuticals Construction Materials National Defense Products... Disposal Extended Producer Responsibilities (Take-Back Programs) Recycle Core Competencies for the Product Stewardship Professional 4

5 PS has global implications and it combines many technical disciplines to help ensure products can be used safely and in compliance with the national and local regulations that apply to the markets where the products are used. Common PS activities include: Adverse Event Recording & Response Global Chemical & Product Safety Regulations Safety Data Sheets, Labels, & Safe Handling Instructions Dangerous Goods Transportation Customer Inquiries Product Stewardship Banned / Restricted Substances Management Marketing Claims and Declarations Sustainable Product Design / Development Recycling & Take-back Programs Product Exposure & Risk Assessment Product Safety Testing Profile of the Product Stewardship Professional Because formal academic training in PS is limited, the profession is made up of individuals with varied backgrounds. Practitioners often come to the profession with expertise in either chemistry, engineering, occupational / industrial hygiene, toxicology, environmental science, public health, or related fields. These technical backgrounds serve as a solid foundation upon which one can build a career as a PS professional but, to be effective, one must supplement these technical competencies through either in-house on-the-job training and / or third-party technical workshops. The PS professional may work as a generalist who draws upon the expertise of others to meet product safety goals or may be a technical expert in one or more of the fields necessary to help ensure product safety. In either case, the most effective PS professionals are competent in each of the technical disciplines that fall within the scope of PS. Core Competencies for the Product Stewardship Professional 5

6 Employment Profile Industry professionals tend to agree that we have seen steady growth in the profession worldwide and that this growth is expected to continue. The Conference Board, Inc. a non-profit business membership and research association noted the trend of increased societal demand on corporations for improved responsibility regarding the products they produce and the potential risks to people and the environment, and that industry is responding (2013): The Product Stewardship and Regulatory Affairs function is evolving into a business-critical driver with the potential to have an impact on the very core of an organization its societal license to operate and go to market. PS professionals come from nearly every sector of the marketplace from the manufacturers of the chemicals that are used to make the consumer products in our everyday lives, to the local grocery chain that wants to only offer their customers goods in sustainable packaging. Even service industries like those that clean commercial office spaces are demanding safer and more sustainable products to do their job. The trend is pervasive, impossible for businesses to ignore, and reflects our new future. Waste Handlers / Recyclers Government Retailers Packagers Consultants / Service Providers Product Stewardship Special Interest Groups / NGOs Formulators Academia Manufacturers Service Industries Core Competencies for the Product Stewardship Professional 6

7 Organizational Structure & Roles PS organizational structures and individual roles vary from one enterprise or institution to the next. In commercial enterprises, the size and geographic configuration of the company, its product portfolio, its market countries, and its PS goals will be the primary factors that drive how the PS professionals are organized. They will also affect whether that organization is one individual who, among many other duties, provides general PS support to the entire enterprise or is instead a small to very large multi-disciplined team of professionals that operate under a central organization and/or that reports within a particular business function. The Conference Board, Inc. has defined the following core roles of a high-functioning product stewardship and regulatory affairs organization: Functional leadership Compliance program management Regulatory expertise Toxicology Product hazard communication Regulatory systems/data support Product stewardship advocacy Core Competencies Overview This core competencies document has been developed to: serve as a foundation on which to build global knowledge of the profession, assist potential employers and employees in identifying opportunities to advance the profession, and define the role of PS in advancing environmental, health and safety protections and facilitating commercial supply chains. This document divides the core competencies into the following three major domains: Each of the core competency descriptions below begin with the basic knowledge that any highly effective PS professional should possess followed by examples of more specialized or advanced topics that one might seek depending on one s specific work circumstances or interests. Technical Regulatory Professional Core Competencies for the Product Stewardship Professional 7

8 Technical Core Competencies Effective PS professionals demonstrate competence in the following areas, as applicable to the products for which they are responsible and the position they hold. Basic Science Applies basic scientific concepts from the fields of general chemistry, organic chemistry, biochemistry, analytical chemistry, biology, anatomy, physiology, physics, mathematics, and statistics. Manufacturing / Engineering Principles Describe how intermediate and consumer products are manufactured, including raw materials used, intended and unintended reactions that occur, the factors that influence product quality, and the impurities that may be present. Describe the chemistry associated with product use throughout the supply chain to the extent that the physical properties of the products can be understood and the product s end-of-service-life can be identified. Select and apply environmental control technologies, including wastewater treatment and air emissions control technologies. Toxicology Characterize and describe basic toxicological principles, including dose-response; routes of exposure; principles of absorption, distribution, metabolism, and accumulation / excretion; common toxicological effects and target organs; additive, synergistic, and antagonistic effects; in vitro and in vivo toxicological testing methods and animal welfare issues; exposure limit development; and qualitative and quantitative structural activity relationships and models. Environmental Chemistry & Ecotoxicology Characterize and describe basic principles of environmental release & fate, including the characteristics of common environmental compartments; the impact of chemical solubility, volatility, adsorption properties, hydrolysis properties, partition coefficients, biodegradation / mineralization properties, and photodegradation properties on its fate in the environment; the principles of environmental persistence and bio-concentration / bio-accumulation in the food chain; and ozone depletion. Characterize and describe basic ecotoxicological principles, including issues regarding specific species, dose-response, and basic principles of monitoring the environment. Safety Data Sheet (SDS) and Label Authoring Applies basic principles of chemical hazard communication including the format and content of SDS and hazard warning labels and common terminology, including the selection, use, and interpretation of reliable physical-chemical and toxicological data for preparing the SDS; a working knowledge of the applicable national and international criteria for hazard classification for substances and mixtures; applicable national and international exposure limits; the selection of specific release and exposure prevention and incident mitigation measures; regulations to be communicated on the SDS; and the use of specialized information technology tools. Core Competencies for the Product Stewardship Professional 8

9 Exposure Assessment and Control Describe and apply basic principles of industrial hygiene, including the strengths and limitations of personal protective equipment including chemical protective clothing and respiratory protective equipment; control strategies including local exhaust ventilation and other engineering solutions, and the principles of elimination and substitution. Understands the basic principles of exposure assessment including exposure limits, sampling and analytical methods, and exposure models applicable to workers, consumers, and the public exposed indirectly via the environment. Risk Assessment Applies basic principles of risk assessment, including identification of critical health effects; determining relevant exposure concentrations / dose levels; quantitative risk determinations; risk management measures; and related documentation. Sustainability Describe basic principles of sustainability, including product life-cycle analysis; sustainable product development / design / substitution; end-of-service-life issues, including waste minimization, recycling, re-use / re-purpose, take-back programs, disposal / destruction; certification and product labeling programs; and customer sustainability goals. Product Safety Testing Describe basic principles of conducting physical-chemical properties testing and basic in vitro toxicology laboratory tests. Inherent Safe Product Design / Development Describe and apply the basic principles of design and development of safer products and their containers for transporting or handling to mitigate risk. This may include the use of micro-encapsulates so hazardous materials can be handled safely yet remain effective at the point of use; the development of alternatives to substances that are persist in the environment and/or that bioaccumulate; formulating products with safer alternatives; and the design of specialized material-handling equipment to reduce releases and exposure. Core Competencies for the Product Stewardship Professional 9

10 Regulatory Core Competencies Effective PS professionals are competent in each of the following regulatory areas, with specialized knowledge of the products for which they are responsible and the position they hold. Chemical Hazard Communication Describe and apply basic requirements and methods for chemical hazard communication as applicable to the products being placed on the market and as required by the countries / regions applicable to the business, including the requirements for preparing and distributing safety data sheets, the requirements for labeling containers, the role of safe handling instructions in preventing hazardous materials incidents, and the importance of this information to long-term business continuity and minimizing legal liability. National Chemicals Management Laws / Regulations Recognize the growing number of regions / countries around the world have, or are developing, chemical inventories and requirements that govern the manufacture, import, and/or otherwise placing chemicals into commerce within their boarders. Describe and apply basic requirements that apply to the products for which they are responsible, including new and existing substance notifications / registrations, physical / chemical / toxicological testing, significant adverse effects recording / reporting, banned / restricted substances, hazardous materials packaging regulations, VOC / ozone-depleting substances restrictions, and transport / handling / use licenses. Characterize and express the importance of these regulations to successful business development and long-term business continuity. Consumer Products Regulations Describe and apply regulations that pertain to chemical products intended for the general public (e.g., household surface cleaning products, home and/or automotive maintenance / repair products), which may include substance use restrictions, safety determinations, sustainability goals, product formula registries, and product packaging and labeling requirements. Cosmetic / Personal Care Products Regulations Describe and apply regulations that pertain to cosmetics and/or personal care products (shampoo, deodorant, sunscreen, etc.), including permissible substance use and concentration limits; product safety determinations; packaging and labeling requirements; and requirements that pertain to marketing claims. Food Packaging / Food Contact Laws / Regulations May seek general or specialized knowledge in the regulations that pertain to food and beverage contact and packaging materials, including acceptable monomers, polymers, resins, and additives; their permissible applications (e.g. types of foods, types of contact); approval / clearance of new materials; chemical migration restrictions; and quality assurance / quality control; and sustainability issues that pertain to the packaging materials being developed. Core Competencies for the Product Stewardship Professional 10

11 Pesticides / Biocides / Plant Protection Products Regulations Describe and apply regulations that pertain to the manufacture, import, and/or otherwise placing into commerce pesticides, biocides, and/or plant protection products, including testing requirements for safety and effectiveness, how to prepare the applicable regulatory documents (e.g. new substance notifications / registrations, license applications), product packaging and labeling requirements, and use / application instructions. Sector of Use Regulations & Expectations Describe and apply regulations that pertain to a product s specific sector of use such as medical devices, food additives / preservatives, and children s products (e.g., toys, children s clothing), including banned / restricted substances; safety testing; documentation and recordkeeping; significant adverse effects recording / reporting, development of product specifications; quality assurance / quality control of globally sourced raw materials; and end-of-life cycle and extended producer responsibilities within supply chains. Dangerous Goods Transportation Regulations Describe and apply regulations that pertain to the transport of dangerous goods, including national departments of transportation; International Air Transport Association (IATA) / International Civil Aviation Organization (ICAO); the European Agreements Concerning the International Carriage of Dangerous Goods by Road (ADR), by rail (RID), or by inland waterways (ADN); and the International Maritime Dangerous Goods (IMDG) code. Banned / Restricted Substances Regulations Describe and apply regulations and international treaties that pertain to the manufacture, import, and/or use of banned / restricted substances, including persistent organic pollutants (POPs), chemicals that can be used as weapons, substances and precursors that may be used to manufacture illicit drugs, minerals identified as conflict minerals, substances derived from or that may contain genetically modified organisms (GMO), the EU list of substances of very high concern (SVHC), substances that are banned or restricted for use in electronics and electrical equipment (e.g., EU RoHS), and substances restricted in the manufacture of automobiles (GADSL). Core Competencies for the Product Stewardship Professional 11

12 Professional Core Competencies Effective PS professionals demonstrate ability in each of the following professional skills / behaviors, as may be applicable to the position they hold. Individual Effectiveness Works independently, solves problems using good judgment, is ethical, organized and prioritizes, has excellent verbal and written communication / presentation skills, is persuasive, able to translate technical information into layperson terms, completes work in a timely manner, strong attention to detail, and stays abreast of regulatory changes / trends. Sensitive to matters of confidentiality / non-disclosure, understands the goals / objectives of the business and takes these into account without jeopardizing the goals / objectives of PS. Teamwork Works well in teams, an individual contributor, as a facilitator, and leader. Collaborates within and outside the PS organization, at all levels, both locally and globally. Management Acquires, allocates, and controls resources to accomplish PS goals in an effective and efficient manner. Inspires others to excel. Translates broad strategies into specific objectives. Establishes policies and procedures to standardize work. Applies the principles of cost-benefit analysis, auditing, investigation methods, data management and integration, planning, delegation of authority, accountability, risk communication, conflict resolution, issue / crisis management, organizational structure and culture, and decision making. Business Acumen Understands the goals of business and its need to compete in a global marketplace, and identifies opportunities to apply PS in support of those goals. Affects necessary changes that move the organization s culture forward and communicates PS principles and activities using the language of business leaders. Understands the legislative / regulatory processes applicable to key markets, product liability, and product risk management. Core Competencies for the Product Stewardship Professional 12

13 References Cited The Conference Board, Inc. (2013). Council Perspectives Insights from The Conference Board Product Stewardship and Regulatory Affairs Council. Building an Effective Product Stewardship and Regulatory Affairs Organization. Council Perspective CP-044. January Available at: cfm?publicationid =2413 About the Product Stewardship Society The Product Stewardship Society provides resources, professional development, and networking opportunities to enable product stewardship practitioners to ensure safety, manage regulatory compliance and promote responsible design, development, and management of products throughout their lifecycle. Learn more at Core Competencies for the Product Stewardship Professional 13