In 2015, the principal trends will include (1) growth within emerging markets outside the Western region – where local players are ahead of the competition thanks to lower manufacturing costs, (2) tailored innovative solutions to both end users and supply chain players, (3) business and operational strategies driven by market demand, competitive landscape, regulations to increase revenue and the desire to win a better market share. In order for global companies to succeed they will need to take all these factors into consideration and be ready to dramatically adjust their overall business models to new market demands. But more importantly, green chemistry/sustainability and the elimination of the commerce of chemistries with unfavorable environmental characteristics is another important trend that offers boundless opportunities for companies to create new products through advanced manufacturing biotechnologies using biomass and new agricultural materials. These trends will play a major part in the year(s) to come, but there tends to be one overarching tenant in this discussion which I will focus on and that is increased regulatory burdens on chemical manufacturers to demonstrate environmental safety of their processes and products.
As a practicing ecotoxicologist, environmental exposure analyst and environmental risk assessor for major chemical companies for the past 25+ years I will focus my remarks regarding the key trends in the chemical industry in 2015 toward the environmental safety perspective. As I note above, the overarching tenant in this discussion is the certainty of increased regulatory pressures regarding environmental issues that chemical companies will face in 2015 and beyond and the increasing time and resources required to address these regulatory requirements.
Specific key topics that I wish to address include TSCA reform within the US, risk assessment in emerging markets, sustainability/green chemistry, endocrine disruption and finally, Persistent/Bioaccumulative/Toxic [PBT] chemicals and Persistent Organic Pollutants [POPs].
The Toxic Substances Control Act [TSCA] was passed in 1976 and is the principal legislation within the US for ensuring the safety of chemicals used in commerce. At the time of this writing a modernized bill [Senate S.697] has been amended and approved by the Environment and Public Works Committee to be presented to the full Senate for review. Importantly, the amended bill has provisions for, among other items, a requirement that USEPA make an affirmative determination that a new chemical does not present an unreasonable risk of injury under its intended conditions of use before it can be manufactured, imported or processed in the US. The bill would also require EPA to designate existing chemicals (i.e., those on EPA’s TSCA Inventory) as “high” or “low” priority through a riskbased prioritization process and then conduct safety assessments of and make safety determinations about the high-priority chemicals. Clearly, this initiative while beneficial with regard to environmental health will increase regulatory costs as a function of increased toxicity testing and risk assessment activities for chemical registrants.
China and Latin America [LATAM] are emerging markets for chemical companies. In addition to the nascent nature of these markets on the business side of the equation, the environmental safety assessment approaches of these emerging markets are in the developmental stages as well. In general, the assessment of chemical safety in these markets are conservative and reflect a Tier I level of analysis. Tier I risk assessment are maximally conservative in terms of toxicity and exposure. In some instances these conservative assessments are based not on the risk assessment paradigm, i.e., toxicity versus exposure but on a hazard based approach. The hazard based approach evaluates chemical safety as a function of inherent toxicity of the chemical entity and lacks the scientific rigor of the risk based approach. The industry as a whole must educate the regulatory authorities in these emerging markets with regard to the state of the art of the risk assessment process and to the downside of chemical safety assessment based solely on hazard.
Sustainability/Green Chemistry initiatives are growing significantly in today’s market place. The sustainability/green chemistry initiatives encompass sourcing and selection of precursor chemistries to chemical use practices. With regard to sourcing and selection of chemical precursors, consideration is of course given to cost but also and perhaps more importantly to the environmental profile of a particular chemistry in terms of characteristics such as, persistence, bioaccumulation potential and toxicity. Concerning sustainability and end product use, 2015 will see increased insistence of the market place for materials with low precursor and end product use volume, low environmental impact and relatively superior performance/safety profiles.
Endocrine disruption issues have been at the forefront of the science of chemical safety assessments for 50+ years beginning with the publication of Rachael Carson’s Silent Spring in 1962. At issue is the activity of exogenous chemicals that mimic endogenous hormonal substances. Adverse effects in humans can include reproductive impairment, potential increased hormonal based cancer incidences, e.g., testicular, breast and prostate and premature puberty. In wildlife, causal links of chemicals to endocrine disruption have been established for aquatic invertebrates [imposex in whelks], egg shell thinning in birds [DDT], reproductive impairment in fish evidenced by changes in reproductive organ structure and function, and in terrestrial mammalian species [PCBs]. With regard to the potential environmental effects, it is noteworthy that most of the occurrences of these effects were found to occur in heavily contaminated areas. USEPA has developed an endocrine testing program and should be commended for their efforts. However, while the breadth of the testing program is broad and comprehensive, it lacks a clearly defined risk assessment paradigm. Testing may provide toxicity endpoints in dose concentrations of sufficient magnitude to induce a toxic response in test organisms. However, how these endpoint concentrations relate to exogenous environmental chemical concentrations orders of magnitude lower, with less activity than the endogenous hormones remains to be established. Hormesis, the notion of chemical activity at very low concentrations with regard to the cellular mechanisms of the endocrine system is under significant debate. However, the consensus appears to be that hormesis in this regard is NOT a plausible mechanism for endocrine activity. Chemical mixture toxicity may a play a role in allowing low levels of exogenous chemicals to affect the endocrine system. Testing paradigms do not currently capture the mechanisms of the toxicological effects induced by chemical mixtures.
PBT chemicals are persistent in the environment, toxic and by their lipophilic nature accumulate within the food chain. As such PBTs effect human and ecosystem health. Persistent Organic Pollutants [POPs], codified by the 2001 Stockholm Convention, are chemical entities that like PBT materials persist in the environment, bioaccumulate through the food chain and pose a risk of adverse effects to human health and the environment. POPs have been identified under the auspices of the Stockholm Convention and slated for elimination from commerce with few exceptions e.g., DDT for malaria abatement in developing countries. The criteria for PBT and POPs are defined nationally/geographically dependent upon half lives in soil, water and air, octanol water partition coefficient (Log P) or Bioaccumulation Factors (BCF) and species specific toxicity levels. For chemical manufacturers the challenge is to eliminate potential PBT or POPs from their synthesis routes and /or product portfolios. Substitutions of PBT chemicals from marketed formulations can be costly and can alter the efficacy of the formulated product. The key then is to define potential PBT materials during the initial stages of product research and development and to eliminate them from process/products prior to commercialization where replacement may become problematic.
These key trends will continue to influence the chemical market place in 2015. Increased regulatory burdens will lengthen product development cycle time and increase costs of developing new chemical active ingredients. The use of state of the art risk assessment science at the product concept inception phase through sales and marketing will reduce development costs, support appropriate product stewardship and reduce potential product liability costs. Finally, awareness of the key trends in the chemical market space and forward looking risk assessment strategies with regard to environmental health and safety can be employed as a value added component of a chemical manufacturer’s product portfolio.