3.11 European Chemical Control Regulations: Registration, Evaluation, and Authorization of Chemicals (REACHs)
In June 2007, a new set of regulatory requirements for the REACH substances came into force (Regulation (EC) No. 1907/2006) (7). This is the most comprehensive set of chemical regulations to be enacted in the EU and the impact of these regulations will be global in nature. In the future, based on a specified set of deadlines all substances produced, sold, or imported in the EU will have to be registered. The regulations remove the distinction between new and existing substances and require the same level of comprehensive data to be submitted for all substances with the amount of information varying based on volume and inherent hazard.
For all substances produced above 10 tons annually, a chemical safety assessment will have to be submitted as part of the required information. For substances determined to be dangerous, a chemical safety report (CSR) must be developed and that CSR must describe exposure scenarios. Exposure scenarios are sets of conditions that describe how substances are manufactured and used during manufacture and ultimate use by the downstream users. The CSR must also have information on how the manufacturer or importer controls or recommends to control exposures to workers and the environment. The exposure scenarios must also include recommended risk management measures for all “identified uses.” These exposure scenarios and risk management measures will then need to be annexed in some way to MSDSs.
The REACH requirements further emphasize the need for industrial hygiene skills and practice to be involved in these chemical control regulations. Exposure evaluation, specifically for downstream uses of chemical substances requires exposure evaluation skills. Overall the need to determine exposure through the life cycle of a substance and recommended control measures are an integral part of these precedent setting regulations.
3.12 Government‐Led Voluntary Efforts
The word stewardship has become popular with the EPA in terms of voluntary programs to secure industry segment commitments. There have been multiple voluntary initiatives that accomplish PS principles in the absence of regulation. EPA actively facilitates coordination and collaboration among states, local governments, industry, and nongovernmental organizations on these issues. Many of their efforts are accomplished through voluntary programs that offer certain incentives in terms of efficiency of new chemical reviews or potential regulatory controls.
In a September 2007 EPA report from the Office of Inspector General, the following was noted: “The most significant change we found was in how EPA uses the term stewardship. Over the past three years, the scope of this term has expanded from 6 programs to over 400 stewardship opportunities. Now, these efforts encompass the majority of EPA's voluntary efforts” (EPA office of Inspector General, Report No. 2007‐P‐00041) (8).
3.12.1 Related EPA Program Examples
Presidential Green Chemistry Challenge Promotes pollution prevention through an EPA Design for the Environment partnership with the chemistry community. Through an awards program, the Green Chemistry Challenge recognizes and promotes chemical technologies that reduce or eliminate the use or generation of hazardous substances during the design, manufacture, and use of chemical products and processes. Individuals, groups, and organizations can compete for annual awards in recognition of innovations in cleaner, cheaper, and smarter chemistry.
Environmentally Preferable Purchasing Program EPA leverages the strength of federal buying power as an incentive for industry to develop environmentally preferable products. Federal, state, and local government and private‐sector pilot projects are now incorporating environmental considerations into their purchasing processes.
Design for the Environment Program (DfE) A government–industry partnership that seeks to incorporate environmental considerations into the design and redesign of products, processes, and technical and management systems.
Energy Star Encourages product manufacturers to increase the energy‐efficiency of their products and, at the same time, inform consumers about the money‐saving environmental benefits of products that use less energy.
Consumer Labeling Initiative A voluntary, cooperative effort to foster pollution prevention, empower consumer choice, and improve understanding by presenting clear, consistent, and useful information on household.
3.13 An Example of Occupational Hygiene Input to a Voluntary Product Stewardship Effort
3.13.1 Background
EPA announced the Chemical Right‐to‐Know Initiative on Earth Day 1998. One of its goals was to ensure that adequate data be made publicly available to assess the special impact that industrial chemicals may have on children. Toward meeting this goal, EPA identified industrial/commercial chemicals to which children have a high likelihood of exposure and the information needed to assess the risks to children from these chemicals. EPA pursued the collection, development, and public dissemination of this information through the VCCEP.
In August 1999, EPA announced the initiation of a stakeholder involvement process to get input on all aspects of VCCEP. EPA held three public stakeholder meetings and took comments on possible designs for a voluntary program. EPA also took steps to consider animal welfare and to reduce, or in some cases eliminate, animal testing, while at the same time ensuring that public health is protected. After considering all the comments of interested stakeholders, the Agency developed the VCCEP Pilot.
3.13.2 Voluntary Children's Chemical Evaluation Program (VCCEP)
On 26 December 2000, EPA launched the Voluntary Children's Chemical Evaluation Program (VCCEP) Pilot by asking companies that manufactured or imported one or more of the 23 chemicals selected for the program to volunteer to sponsor their chemicals and provide information on health effects, exposure, risk, and data needs. Thirty‐five companies and 10 consortia responded, volunteering to sponsor 20 chemicals.
Under the VCCEP Pilot, EPA collects three tiers of increasingly detailed information on a chemical from its sponsor. EPA asked companies to volunteer to sponsor their chemical(s) for Tier 1. After completing the evaluation of some Tier 1 chemical assessments, EPA determines if additional data is needed. EPA gives sponsors the opportunity to commit to one tier at a time. Companies are only asked to sponsor particular tiers when EPA believes the data to be provided are necessary to understand the chemical's potential impact on children. During their sponsorship, companies collect and/or develop health effects and exposure information on their chemical(s) and integrate that information in a risk assessment. A “data needs assessment,” also developed by the sponsor, discusses the need for additional data, which can be provided as part of the next tier of information to fully characterize the risks the chemical may pose to children.
3.13.2.1 Alkane Example
Three of the chemicals chosen for the pilot were n‐decane, undecane, and dodecane. These chemicals were sponsored in the pilot by a consortia organized by the ACC. The ACC n‐alkanes VCCEP Consortium Tier 1 submission was reviewed by an independent peer consultation panel in September 2004. That review and EPA's analysis resulted in a short list of additional data/analysis. One item was occupational exposure monitoring data at n‐alkane production facilities. Consortia members had previously checked for this type of data and found that none existed. Traditional IH assessment strategies would not necessarily have developed quantitative data for these alkanes since none of these chemicals have established