Patty's Industrial Hygiene, Program Management and Specialty Areas of Practice. Группа авторов
is understood and in fact practiced in the supply chain. In fact, a fundamental and somewhat contentious element of the Chemical Industry Association of Canada (CIAC) and ACC programs when first developed was the requirement to consider ceasing to do business with those who do not demonstrate the ability to safely handle the products sold to them. The first efforts at risk management include working with customers to foster safe handling of products and identifying and responding to recognized misuse of a product. However, if one failed in those efforts they should consider ceasing business with the offending company.
3.7 Hazard Assessment
Hazard assessment of products is a fundamental element of any PS effort. While hazard communication and transportation regulations require some fundamental hazard data to be generated to determine the physical and health hazards of a product, there is no specific minimum set of data required in the United States for most existing chemicals. The global landscape for hazard data for new chemicals, as defined by multiple chemical control regulations, have moved toward minimum data sets in some countries and is generating the need for additional data to meet risk assessment requirements. In the US registered pesticides are an exception. When developing a “new chemical” as defined by the various chemical control regulations a producer is required to submit what data are available, in the United States, and specific hazard data sets in Canada and the EU depending on the volume and other factors such as specific uses. PS takes this element much further and in essence requires companies to do what is right, “commensurate” with the anticipated hazards and risk. In other words, increased risk requires additional hazard information to be developed and made available in the appropriate manner to product users and in many cases the public. Business‐to‐business or commercial requirements are also increasing the need for increasing hazard data for products.
3.8 Risk Management
Considering and understanding the exposure potential resulting from the practices of all parties in the supply chain, including the customer, is integral to the concept of PS. There are few regulations that require specific producer activities throughout the supply chain. In the recent past, understanding chemical uses and working with users was not generally required by any regulation. This has been changed since the US TSCA was revised by the LCSA and REACH regulations were implemented in the European Union. To meet new requirements on a global basis chemical producers must determine general use and exposure conditions for their products, and develop chemical safety assessments based on this information.
3.9 Product Development
In the United States, new chemicals are regulated by the US EPA Toxic Chemicals Control Act (TSCA), amended by the LCSA in June 2016. When a new chemical substance, as defined by the TSCA regulations is to be put into commerce there are specific data and information requirements for submittal and approval to the EPA. The EPA must in essence approve the commercial production of the chemical based on the data provided and the known uses, exposures, and releases for the product.
For the research phase of new chemicals, there are actually a number of regulatory exceptions in terms of hazard assessment, hazard communication, and provision of information in the more limited supply chain of research and development.
When a manufacturer moves to the point of gaining approval for commercial activity by submitting a Premanufacture Notification (PMN) for a new chemical, PS is evidenced in the PMN form. In Part II of the form, Human Exposure and Environmental Release, submitters have the opportunity to describe use and exposure conditions in their workplace as well as in the sites not controlled by them, specifically the customer or chemical user workplace. The more accurate and precise the information, the better the results of the EPA review can be. Doing a good job in understanding exposure and use can lower the potential for testing requirements or risk management controls such as a significant new use rule (SNUR). The applicable portions of the form are shown below. The PMN form requirements are found in EPA regulations, 40 CFR Part 723 (5).
In 2007, there were 10 countries around the world that had a similar form of chemical control regulation. In 2018, there were over 15 countries and regions. In addition to the United States, they are Australia, Canada, China, European Union, Japan, Korea, New Zealand, Philippines, and Switzerland.
3.10 US EPA Chemical Data Reporting Rule
The Chemical Data Reporting (CDR) rule, under the TSCA, requires manufacturers (including importers) to provide EPA with information on the production and use of chemicals in commerce in large quantities (6).
Under the CDR rule, EPA collects basic exposure‐related information on the types, quantities and uses of chemical substances produced 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