(97d) Global Implications of REACH and TSCA - Moving towards Comprehensive Chemical Management Accountability

Moving Towards Comprehensive Chemical Management Accountability

Jacqueline Sibblies, PE

Environmental Compliance Consulting

P.O. Box 5013, Somerset, NJ 08873

sibbliesj@gmail.com

(908) 531-4029

The recent publication of the United States Environmental Protection Agency’s (USEPA’s) proposed rule to modify the Inventory Update Reporting (IUR) Rule under the Toxic Substances Control Act (TSCA) will certainly cause members of the chemical manufacturing and distribution industry to evaluate the impact(s) of any resulting new and/or modified regulatory requirements that could directly affect their businesses. And with many companies having international affiliations, the onset of changes in regulatory requirements in one global region would most likely affect operations in several other regions. Methods of manufacturing in one country, for example, may have to be revised in order to meet the product quality standards of another.

Then there is also the consideration that must be given to the effect of interrelated regulatory requirements. New or modified regulations could be burdensome to some members of the regulated community, while others may find the new requirements complimentary with existing subject regulations. For some chemical companies, this may be the case with the TSCA IUR and REACH (the Registration, Evaluation, Authorization of Chemical Substances regulations) administered by the European Chemical Agency (ECHA). This paper will present a summary of key requirements of both REACH and IUR regulations with an analytical look at their effects on global operations in the chemical industry.

The Regulations

The REACH regulation covers requirements for chemical handling accountability by all units of the chemical industry supply chain within the European Union. These include manufacturers, exporters and importers of chemical substances, producers, exporters and importers of products or articles that contain chemical substances and end users of these substances and products. As the name indicates, the regulation mandates that responsible individuals evaluate chemicals, products and company operations for applicability to REACH and register said item(s) with the governing agency (ECHA). Registration includes providing classification of the chemical substance(s), detailed physical, chemical and toxicological data on the chemical substance(s), production/preparation method(s) and annual rates, description of the use(s) of these substances, a hazard assessment report (where mandated) and information on the company, site(s) and responsible contact person(s).

The IUR requirements, currently still a subpart of the TSCA Chemical Inventory regulations, stipulate that manufacturers, importers and users chemical substances determine whether their operations are subject to the regulations and, if so, file periodic reports with the governing agency (USEPA). These reports include information on physical and chemical properties of

Table 1 – Overview of REACH and TSCA IUR

reported chemical substances, production and usage at and importation to the site(s) for the principal reporting year, company and site address(es) and responsible official contact details. The submitter is also required to report the estimated total number of workers likely to be exposed to each regulated substance at each site reported.

The proposed amendments to the IUR regulations require more detailed and specific information on the properties and categorizations of chemical substances reported, additional information on worker exposure and releases to the environment, details of the states, concentrations and quantities of these substances if/when they or sent off-site (i.e. exported to other US territories), specifics on processing and usage by the importing entities and information for each calendar year from the last reporting period (in addition to the principal reporting year). The frequency of reporting is also reduced to every four (4) years.

Regulatory Goals and Intents

The preamble to the REACH regulations gave a brief background on previous directives and laws governing chemicals that preceded the REACH regulation, which, to a great extent, incorporates and expands on those requirements. REACH encompasses chemical substances inventory requirements, chemical testing and categorization procedures, human health and safety assessments, environmental preservation measures and the maintenance of profitable commerce. The primary goal of the regulation is to focus the stakeholders of the chemical industry on all key aspects of their operations to gather enough data so that well informed decisions can be made for viable, sustainable operations.

 Similarly, the preamble to the proposed IUR amendments also gave background on previously promulgated regulations governing chemicals, primarily TSCA and its Chemical Substance Inventory rule. While TSCA and the Inventory rule focus on assessing chemical substances and maintain information on their manufacture/import and movement through industry, and the current IUR regulations aim to collect and monitor updates to these data, the proposed regulations seek to effect a more comprehensive, detailed data collection process. The stated goal is to acquire the level of data that will foster more effective worker safety and environmental protection decision making

 Effects On Global Operations

Both REACH and TSCA IUR regulations contain similar core elements, like providing an overseeing agency with detailed information on the regulated substance(s) at a particular site, specifics on manufacture and processing operations, import and export data, usage of these substances and results of human health and safety evaluations. These data are primarily collected and stored electronically, which makes them easily assessable and transferable. This fact coupled with the level of detail required to comply with these regulation raises a specter of concern for several members of the industry. There is the threat of breach of confidentiality, since so much information is required to support a company’s confidentiality claim. There is also the concern of resources required to generate, compile, document and submit the extensive information required, and maintain records for subsequent updates.

And then there is the dimension of business to business accountability. Both sets of regulations require that manufacturers and exporters of a regulated substance submit information on their products’ uses and applications in various commercial applications. Although the regulations offer coding guidelines, for example for usage and concentration ranges, it could be difficult to cite accurate descriptions since some chemical applications can be very unique. An exporter may have reservations affirming use and applicability by an importer.

If importer and exporter are in different regions of the world, they need to verify compliance requirements for applicable regulations. REACH was developed for the countries of the European Union and TSCA IUR regulations were developed for the United States of America and its territories, but each is capable of impacting commercial operations in the others region. A company with business operations in both regions will have personnel familiar with both sets of regulations and so will have the advantage of hands on working knowledge of both systems. A company with no direct business affiliation may need to expend significant resources in order to fulfill compliance of applicable requirements.

On the other hand, there are viable opportunities that can be garnered from REACH and TSCA IUR. To overcome difficulties in attaining regulatory compliance, companies doing business across regions can explore the prospects of forming strategic alliances. Furthermore, the proposed amendments to TSCA IUR, show several similarities with REACH requirements, which are directed towards encouraging members of the chemical industry to develop and conduct business from a sustainability perspective – striking an optimized balance between profitable operation, human health/safety and improving/maintaining the environment. In exploring and devising means of fulfilling these regulatory requirements, companies may also simultaneously take a critical look at various components of business operations for areas where change could, not only bring about ease of regulatory compliance, but also sustainability improvements which will advance business performance.

REFERENCES

 REACH Regulations

www.regulations.gov