domestically and imported into the United States. It constitutes the most comprehensive source of basic screening level and exposure‐related information on chemicals available to EPA, and is used by the Agency to protect the public from potential chemical risks.
The information is collected every four years from manufacturers (including importers) of certain chemicals in commerce generally when production volumes for the chemical are 25 000 pounds or greater for a specific reporting year. Collecting the information every four years assures that EPA and (for non‐confidential data) the public have access to up‐to‐date information on chemicals that are produced in large quantities.
The CDR rule is required by section 8(a) of the TSCA, and was formerly known as the Inventory Update Rule (IUR).
Read the TSCA CDR requirements in the Code of Federal Regulations (40 CFR Part 711).
3.10.1 Exposure‐Related Information Required
Examples of EPA data requirements involving exposure information are: (i) the number of workers “reasonably likely to be exposed” to the chemical at the manufacturing site; (ii) the physical form(s) in which the chemical substance is sent off‐site; (iii) the percentage of total reported production volume associated with each physical form; and (iv) the maximum concentration of the chemical substance at the time it leaves the submitter's manufacturing site or, if the chemical substance is site‐limited, the maximum concentration at the time it is reacted on‐site to produce a different chemical substance; (v) whether the use is consumer or commercial; (vi) if the chemical is used in products intended for children. “Reasonably likely to be exposed” means an exposure to a chemical substance which, under foreseeable conditions of manufacture, processing, distribution in commerce, or use of the chemical, is more likely to occur than to not occur. Covered exposures include exposures through any route of entry, but exclude “accidental” or “theoretical” exposures.
The CDR requirements increase the need to have certain exposure information pertinent to chemical substances in the workplace and in commerce, or during use. Producers will need more detailed information about workplace exposures and producers making more than 300 000 pounds per year per chemical substance will need specific processing and use information as required under the rule. EPA states that its three primary reasons for seeking such information are to tailor a chemical substance's reporting requirements more closely to match EPA's information needs; to obtain new and updated information relating to potential exposures to a subset of chemical substances listed on the TSCA Inventory; and to improve the utility of the information reported. The agency has stated that receipt of this exposure information will “enable EPA to more selectively conduct initial risk screening on a subset of the chemical substances with its purview.” These data will, along with other EPA initiatives to collect hazard data, including the High Production Volume (HPV) Challenge Program and Voluntary Children's Chemical Evaluation Program (VCCEP), allow EPA to prioritize its TSCA Section 4 rulemaking and enforceable consent agreement initiatives. This verbiage emphasizes the increasing need for exposure information and the involvement of IH in this regulatory process.
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
