Introduction of Controlled Use Permit
(Export Only)
TThe Industrial Chemicals (Notification and
Assessment) Act 1989 (the Act) provides a framework for, among other
things, the issue of permits for the introduction of new industrial
chemicals under conditions of controlled use, including chemicals for
Export Only. Regulations were registered on 20 April 2006 enabling the
introduction of chemicals under this new permit category, effective
immediately.
Scope of Controlled Use Permit (Export Only)
Industrial chemicals introduced under the following
scenarios will be eligible for the new Controlled Use Permits (Export
Only):
-
Importation of a new chemical into Australia for
export of entire quantity;
-
Importation of a new chemical into Australia for
use in formulation of products for export of entire quantity;
-
Manufacture of a new chemical in Australia for
export of entire quantity; and
-
Manufacture of a new chemical in Australia for use
in formulation of products for export of entire quantity.
The Controlled Use Permit (Export Only) will be
available for chemicals where low risk can be demonstrated. In
particular, sufficient control measures must be in place to satisfy the
criterion of ‘highly controlled’ (section 22A of the Act. Sufficient
control measures must be in place to prevent exposure to workers and the
public and release to the environment.
The duration of the Controlled Use Permit (Export
Only) will be a maximum of three years (section 22G of the Act). Renewal
of the permit may be allowed provided there is no significant change in
circumstances (section 22B of the Act)
Chemicals prohibited or severely restricted under
Australia’s international obligations will not be eligible for a
Controlled Use Permit (Export Only). For example, new chemicals with
persistent organic pollutant (POPS) characteristics, which include
persistence and bioaccumulation, will not be eligible
Information Required in Application
The basic information required by NICNAS with an
application for a Controlled Use Permit (Export Only) is listed in
subsection 22C(2) of the Act, namely:
-
Uses of the chemical;
-
A summary of the chemical’s effects on
occupational health and safety, public health and the environment;
-
The volume to be introduced over a 3-year period.
The summary of health and environmental effects
requires consideration of the chemical’s health and environmental
hazards and an estimate of the impact of the chemical on workers, the
public and the environment. A legislative condition of the permit is
that there be low risk to occupational health and safety, public health
and the environment
Paragraph 22C(2)(e) allows for further data
requirements in the regulations and, for an application for a Controlled
Use Permit (Export Only), the following items will be required (listed
in Regulation 6B):
-
Information on chemical identity, as in Part B.1
of the Schedule to the Act (for polymers, typical molecular weight
data would be required);
-
Summary of how the chemical meets the definition
of hazardous chemical in the Act;
-
Details of any notification of the chemical in
another country;
-
Concentration of the chemical in products, if the
chemical is an ingredient in products;
-
Detailed information on how the chemical is
controlled, for example, methods of control to prevent release into
the workplace, community and the environment (the Controlled Use
Permit is only for chemicals which are ‘highly controlled’, so this
must be demonstrated by the applicant);
-
Precautions taken for safe storage and transport;
-
Information on emergency procedures, as in Part
B.13 of the Schedule;
-
Country, or countries, to which the chemical is to
be exported; and
-
Label and MSDS for the chemical and products
containing the chemical.
For introduction volumes exceeding 10 tonnes per
year, all available toxicological and ecotoxicological data must be
provided with the application. Toxicological and ecotoxicological
information may be requested in other cases
Form of Application
An electronic template is be available on the
website for applications (Form 1-EOP). It must be submitted to NICNAS
with the fee and the required information for assessment
Joint applications may be made by manufacturers and
importers of a new industrial chemical for Export Only.
An application may be accompanied by an application
(on Form 3) that some of the information provided be treated as exempt
information under section 75 of the Act
Fees
Please refer to the current
Fees and Charges page
for details of the Export Only Permit fees
Further Information
For information regarding applications for the
introduction of chemicals for export only under the new Controlled Use
Permit (Export Only), please contact:
BACKGROUND INFORMATION
The Industrial Chemicals (Notification and
Assessment) Amendment (Low Regulatory Concern Chemicals) Act 2004 (LRCC
Amendment Act) received Royal Assent on 13 July 2004 and Proclamation on
9 August 2004 with the passage of the Industrial Chemicals (Notification
and Assessment) Regulations (the LRCC Regs). The LRCC Amendment Act and
the LRCC Regs provided the legislative framework to implement the
majority of LRCC reforms.
Among the LRCC reform initiatives provided for in
the LRCC Amendment Act, and requiring further development, was the
Controlled Use Permit system, where introducers of new industrial
chemicals for use in a highly controlled manner may be granted a permit.
Introduction must be of low risk to workers, the public and the
environment and safeguards are built into the permit system. Provision
for the Controlled Use Permit system is in Division 1C of the Act,
sections 22A to 22O.
During the LRCC consultation period, industrial
chemicals introduced for export only were identified as suitable for the
Controlled Use Permit system, due to their limited potential for
exposure in Australia. Consequently, a discussion paper based on
consultation with stakeholders and information about Export Only
provisions in other national assessment schemes was published for public
comment in issue no. C12 of the Chemical Gazette on 7 December 2004. The
Final Report and Recommendations was published in the Chemical Gazette
on 3 May 2005.
Safeguards
Under section 22F of the Act, the Director may reject an application for
a Controlled Use Permit (Export Only) if not satisfied that (a)
sufficient data have been provided for assessment and (b) use of the
chemical satisfies the criterion of ‘no unreasonable risk to
occupational health and safety, public health and the environment’.
Guidance for ‘no unreasonable risk’ is included in the NICNAS Handbook
for Notifiers.
Under the permit system in NICNAS, conditions may be
applied to the permit to ensure that use of the chemical will not result
in any unreasonable risk to workers, the public or the environment. The
conditions may refer to any aspect of the chemical’s manufacture,
handling, storage, use or disposal. The conditions may also specify
special packaging and labelling requirements and procedures relating to
potential release of the chemical or its waste products into the
environment. Standard conditions currently applied to permits
acknowledge the role of state and territory legislation in enforcing
workplace and environmental controls.
Under the permit system, the conditions on the
permit are binding, not only on the applicant, but any user of the
chemical. The conditions on the permit can also be varied by the
Director at any time. If any condition on a permit is breached, the
permit may be withdrawn by the Director and/or a penalty imposed.
As with other permits issued by NICNAS, Controlled
Use Permits (Export Only) will be subject to audit by the NICNAS
compliance team. Penalties apply for failure to meet conditions on the
permit, for example, exceeding the maximum volume of introduction
specified on the permit.
Under the new annual reporting requirements in the
Act (Division 3B), holders of Controlled Use Permits (Export Only) will
be required to keep records of any application for 5 years after issue
of the permit. Holders of the permit must also submit an annual report
to NICNAS including details of the chemical’s name and volume and any
information about adverse effects of the chemical on occupational health
and safety, public health and the environment.
