Introduction Importance of Science in the Implementation of TSCA

Document Sample
scope of work template
           Introduction: Importance of
           Science in the Implementation
           of TSCA and REACH—Chemical
           Identity and Risk Assessment

Environmental Regulations and Directives in Europe and laws in
the US that regulate the global chemical industry began to emerge
in the 1970s in response to increased concern over the potential
hazard of chemicals to humans and the environment. These laws
included the Toxic Substances Control Act (TSCA) in the US and the
Sixth Amendment to the Dangerous Substances Directive in 1979 in
Europe. The essence of the review of chemical substances by federal
or international agencies is to do a risk assessment.

Under TSCA, the federal US law has been implemented through
publication of thousands of pages of regulations written in large
part by chemists using chemical terms and chemical substance
identifications. In Europe under the Registration, Evaluation,
Authorisation and Restriction of Chemicals (REACH), nomenclature
and chemical identity issues are beginning to emerge, and to a much
greater extent than they did under previous European laws. The
cornerstone of the implementation of these laws is a close relationship
between lawyers who understand the laws and scientists who
understand the chemistry and the principles of risk assessment.

Confusion about nomenclature has been a serious issue that
has affected implementation of TSCA over the past 32 years.
Regulations are written that specify which chemicals are subject to
them. Unambiguous naming conventions are therefore critical to
the determination as to who is responsible for compliance to the
regulations and for which chemicals. Lack of sufficient attention
to detail in this regard has resulted in the US Environmental
Protection Agency (EPA) publishing regulations covering one or more

The Underlying Foundation of Science used in the Regulation of
Industrial Chemicals

chemicals that are not in commerce as described in the regulations.
Nonylphenol and its derivatives are notable examples of this and are
discussed in Chapter 4.

REACH will require companies and the European Chemicals Agency
(ECHA) to pay much more attention to chemical naming conventions,
particularly in terms of the ‘One Substance One Registration’ (OSOR)
principle. The danger is that different companies may use different
naming conventions to identify their chemicals, which could lead
to multiple registrations for the same substance and the consequent
waste of time, money, and resources. Different naming conventions
will result in difficulties in organizing Substance Information
Exchange Forums (SIEF) and consortia formed to address common
interests in issues such as data sharing and testing costs for the same
chemical substance.

The essence of the review of chemical substances by federal or
international bodies is to carry out a risk assessment. This requires
knowledge of two basic factors: hazard and exposure. The
fundamentals of risk assessment and how risk assessment is used
in the regulation of industrial chemicals and consumer products
are addressed in Chapter 2. In Chapter 3, the International Union
of Pure and Applied Chemistry (IUPAC) and Chemical Abstracts
Services (CAS) nomenclature systems will be discussed. Chapters
4 and 5, address complex nomenclature issues encountered under
TSCA, and nomenclature issues described in the Technical Guidance
Document (TGD) written to assist companies to comply with REACH
respectively. The TGD is titled ‘Substance Identification and Naming’
in REACH, and was formerly known as the ‘REACH Implementation
Project’ (RIP) 3.10 before REACH came into force on 1 June 1
2007. Chapters 4 and 5 discuss non-polymer naming conventions.
Chapter 6 discusses polymer nomenclature and implications in the
determination of inventory status under TSCA, and confidentiality
issues under REACH. Polymers per se do not need to be registered
under REACH, but present significant problems because monomers
and other reactants present in them in reacted form do have to be
registered. This requirement leads to significant confidentiality issues


and is being addressed in European courts after a challenge by an
industry group.

Chapter 7 discusses regulation of nanoparticles under REACH
and TSCA. Chemical identity/nomenclature issues and risk
assessment for nanoparticles are included in this discussion. The
book therefore concludes with this new chemical technology that
has enormous potential in commercial uses and benefits such as in
medical applications, and the potential for harm to humans and the
environment due to its unique physical state. EPA and ECHA have
commented on how they plan to regulate nanoparticles, and the
former has begun to do so, but this is one area where traditional and
existing regulatory schemes (and even the science used to determine
risk) may be insufficient.


How are you planning on using Docstoc?