Bills Digest No. 127 2003-04
Industrial Chemicals (Notification and Assessment)
Amendment (Low Regulatory Concern Chemicals) Bill 2004
WARNING:
This Digest was prepared for debate. It reflects the legislation as
introduced and does not canvass subsequent amendments. This Digest
does not have any official legal status. Other sources should be
consulted to determine the subsequent official status of the
Bill.
CONTENTS
Passage History
Purpose
Background
Main Provisions
Concluding Comments
Endnotes
Contact Officer & Copyright Details
Passage History
Industrial Chemicals (Notification
and Assessment) Amendment (Low Regulatory Concern Chemicals) Bill
2004
Date
Introduced: 31
March 2004
House: House of Representatives
Portfolio: Health and Ageing
Commencement:
Sections 1 to 3 commence
on Royal Assent. The operative sections of the Act (Schedule 1)
commence on a day to be fixed by Proclamation, or six months after
Royal Assent.
To amend the Industrial
Chemicals (Notification and Assessment) Act 1989 to streamline
some assessment and permitting processes for the manufacturing or
importation of certain categories of industrial chemicals.
The Industrial Chemicals (Notification and Assessment) Act
1989 (the Act) provides the legislative framework for the
National Industrial Chemicals Notification and Assessment Scheme
(NICNAS). NICNAS assesses industrial chemicals(1) that
are proposed to be imported into, or manufactured in, ( introduced
in the language of the Act) Australia for the first time. The
assessment is intended to identify potential risks to occupational
health, public health and the environment that may be associated
with the chemical s use. Existing chemicals listed on the
Australian Inventory of Chemical Substances (AICS) may also be
assessed where there are environmental or health concerns about
these. In general, however, chemicals on the AICS may be introduced
into Australia without any assessment or permitting
process.(2)
NICNAS currently operates on a cost recovery basis, both through
assessment and administrative charges for new chemical assessments
and company registration charges. A standard assessment application
fee is $12,741.(3) Registration is required if a company
introduces chemicals to the value of $500,000 or more a year. About
700 companies are registered with NICNAS. Registration fees are
$1,343 for introductions between $500,000 and $5 million a year,
and $7,833 for above $5 million a year.(4) Overall,
NICNAS recovers approximately $4 million per year from the
industrial chemicals sector.
In March 2001, the Underpinning Australia s Industrial
Growth report by the Chemicals and Plastics Action Agenda
Steering Group was handed to the Commonwealth
Government.(5) This cited the high cost of assessing
chemicals, including so-called chemicals of low concern that were
not required to be assessed by NICNAS equivalents in the USA or
Europe, as being an impediment to the international competitiveness
of Australia s chemicals and plastics industries.(6) In
its December 2002
response(7) to the report, the Government said that
it would consider and develop options for access to adequately
assessed and/or tested chemicals presenting low regulatory concern
.(8) A mixed government-industry-public/environment Low
Regulatory Concern Chemicals (LRCC) Taskforce was subsequently
formed to develop these options.(9) According to its
final report(10), the LRCC Taskforce conducted
extensive consultation, meeting with over 90 companies, individuals
and representatives of state and territory agencies and community
groups including the ACTU and environmental groups .(11)
A discussion paper was also released in May 2003 for public
comment.
The LRCC Taskforce report contains 12 groups of recommendations.
Many of these recommendations, such as those relating to
international cooperation and community participation, do not
require legislation or are issues for future implementation. The
main recommendations that require legislation and hence are
contained in the Bill, include:
The
introduction of self-assessment procedures for persons wishing to
introduce certain chemicals. The Bill requires certain
pre-screening by NICNAS of such applications and also introduces
annual reporting and record keeping obligations for, amongst
things, NICNAS audit purposes
-
New permit categories for low-hazard and/or low concern
chemicals, including a low hazard permit for chemicals of low
volume, an early introduction permit system for low hazard and low
risk chemicals and a new permit category for controlled use
chemicals. In addition some permits will be able to be renewed by
administrative processes rather than being required to undergo full
NICNAS assessment processes
-
New exemptions from assessment processes or permit requirements
for LRCCs in certain circumstances, including higher thresholds
under low volume schemes, and
-
A range of other changes, including enabling the NICNAS Director
to enforce any conditions to which a chemical listed on the AICS is
subject, and mandatory company registration for all chemical
introducers.
The Act was also amended in 2003
through the Industrial Chemicals (Notification and Assessment)
Act 2003. The main change from that Act was the lifting of the
maximum quantity allowed to be introduced under what is called a
commercial evaluation permit from 2000kg to 4000kg. The relevant
Bills
Digest commented that the rationale for lifting the limit
appeared to rest only on anecdotal evidence from industry. It also
noted the safeguards proposed to counterbalance the increased limit
were to be introduced by regulation and there was no guarantee that
these would in fact be implemented once the Bill was passed.
However, these regulations were in fact enacted through the
Industrial Chemicals (Notification and Assessment) Amendment
Regulations 2003 (No. 1).
Items 6 and 7 effectively
replace the term hazardous substance with hazardous chemical in the
definitions section (section 5) of the Act. As currently, the
meaning of the term is to be defined in regulations. No reason is
given in the Explanatory Memorandum for the substitution of
chemical for substance .
Item 19 inserts new subsections
5(2) and (3) so as to define what is a
non-hazardous chemical under the Act.(12) A number of
conditions must be met for a chemical to come within this
definition, including under new paragraph 5(2)(e)
that its introduction is consistent with the reasonable protection
of occupational health and safety, public health and the
environment . New subsection 5(3) lists a large
number of matters that the Director must take account of in
assessing whether new paragraph 5(2)(e) is
satisfied. Amongst other things, non-hazardous chemicals may be
eligible for the proposed self-assessment certificate system in
Part 3 of the Act.
Items 20-38 deal with the Australian Inventory
of Chemical Substances (AICS), which lists chemicals that have
already been introduced into Australia. The Act currently divides
ACIS into confidential and non-confidential categories.
Item 21 inserts new subsection
11(4) so as to limit the circumstances in which a
chemical listed on the ACIS may be imported without going through
an assessment process or obtaining a permit. Specifically, if the
listing provides that the introduction of the chemical is subject
to a condition under new section 13, the
introduction must take place in accordance with the condition,
otherwise an assessment certificate or permit will be required.
Items 22-24 will allow the NICNAS Director to
annotate listings in either category with details of the assessment
and any condition(s) to which the introduction of a chemical is
subject etc. In relation to the non-confidential category, the
Explanatory Memorandum to the Bill comments that:
this will give industry and the community better
access to information about industrial chemicals and introducers
will no longer have to try to envisage what uses their chemicals
might be put to in the future because a particular chemical will
only be able to be introduced for the specific use or uses that are
specified for that chemical in the AICS. This will also prevent
chemicals that have been assessed for a particular use from being
imported or manufactured for a different use that has not been
assessed, and which could be more harmful to health, safety and the
environment.(13)
Item 24 inserts new section
13A which has the effect of requiring the NICNAS Director
to notify the person introducing the chemical in
question(14) (the introduction will eventually result in
its listing on AICS) that they intend to include and/or vary any
particulars on the AICS and allow that person 28 days to make a
case why those particulars should be included/varied. A decision of
the Director rejecting the objection to the inclusion/variation of
particulars is reviewable by the Administrative Appeals Tribunal
(AAT).(15)
Item 25 inserts new section
13B. This gives holders of assessment
certificates(16) the option to request that the relevant
chemical be included on the non-confidential section of the AICS
before the five-year period following the assessment of the
chemical has ended.(17) The incentive for certificate
holders to make the request within 28 days of being given an
assessment certificate is that the early listing of the chemical in
these cases will not attract a fee. Presumably this amendment to
the Act is designed to increase the amount of information about
relevant chemicals on the public record.
Item 27 adds a new section 15A
which creates an offence of failing to comply with a condition to
which a chemical is subject under the AICS in new section
13. The maximum penalty is 120 penalty units
($13 200) for individuals, and five times that for companies.
The Explanatory Memorandum comments:
This is a serious offence under the Act, as a
breach of a condition that has been assessed in the context of a
very specific combination of circumstances such as use, handling
and storage of the chemical, could present a serious danger to
occupational health and safety, public health and the environment
if the industrial chemical is used, handled and/or stored for a
different, unassessed use.(18)
Existing section 19 deals with the transfer by the NICNAS
Director of a chemical from the confidential section to the
non-confidential section of the AICS. In general, this occurs five
years after the listing of the chemical unless the Director
considers that the publication of some or all of the chemical s
particulars could reasonably be expected to substantially prejudice
the commercial interest of the person introducing the chemical and
this prejudice outweighs the public interest in the publication of
those particulars.(19) The transfer cannot take place
for at least 28 days after the Director s decision or pending the
completion of a review by the AAT. Item 32 amends
paragraph 19(7)(b) to clarify that, where the
Director decides to transfer a chemical to the non-confidential
section of the AICS, the transfer of the particulars of the
chemical must also be delayed as mentioned above.
Existing Part 3, a key component of the Act, deals with the
notification and assessment processes for industrial chemicals. In
general, such chemicals cannot be introduced unless they have gone
through an assessment process: existing subsection 21(1A). However,
this does not apply in the situations outlined in existing
subsections 21(2)-(4), including where certain permits have been
issued. Item 39 amends subsection 21(2) to create
a new category of permit a controlled use chemicals permit. Details
of the new controlled use permit system are provided by new
Division 1C of Part 3 of the Act (item
84). In relation to this new category, the Explanatory
Memorandum comments:
Some new chemicals are not introduced to Australia
because the notification and assessment costs may not be
recoverable, the chemical may have limited available data or the
quantity necessary for Australian introduction may exceed the
current permit or exemption allowances. Such chemicals are not
available to Australian manufacturing industry although they may be
able to be used in a controlled way in low risk situations and may
be of benefit to the Australian economy .
Establishing a new category and criteria for a
Controlled Use Permit for chemicals to be introduced, handled and
used in low risk situations would broaden the range of new
chemicals potentially available to the Australian industry at a
lower regulatory cost. This will enable industry to bring chemicals
quickly to market and capitalise on business opportunities .
Establishment of the category will result in the potential for the
workforce to be exposed to a greater number of new chemicals. It
will be necessary for criteria for the category to be established
such that introducers of chemicals ensure that all hazards and
risks are understood and controlled. The guidelines for the
category should also ensure that risks to the public and to the
environment are controlled.(20)
Item 41 amends subsection 21(4) to increase the
quantity under the existing low volume chemicals exemption from
10kg in any 12 month period to 100kg in any 12 month period.
Item 42 amends paragraph 21(4)(b) to provide
that a person introducing chemicals under the low volume chemicals
exemption of up to 100kg per year must meet certain requirements
prescribed in the regulations. According to the Explanatory
Memorandum:
the regulations will ensure that the increased
quantity allowed under the exemption is balanced with requirements
for the introducer to keep records for 5 years and to make an
annual report to the Director.(21)
Failure to meet the prescribed requirements in the regulations
will be an offence under section 21(1), attracting a maximum
penalty of 300 penalty units ($33 000), and five times that
for companies.
Item 43 inserts new subsection
21(6) which incorporates a number of new exemptions (or
qualifies existing exemptions) regarding the prohibition on
introducing new chemicals without assessment/permit. The
Explanatory Memorandum comments that:
Each of the new or amended exemptions under new
section 21(6) are accompanied by new annual reporting requirements
for introducers under each exemption category, in new section
21AA.(22)
If a person fails to satisfy any of the provisions in
new section 21(6), they will commit an offence
under existing subsection 21(1). This is consistent with the rest
of existing section 21.
Item 44 inserts new sections
21AA and 21AB. New section
21AA requires that persons introducing chemicals under
either of the exemption categories in subsections 21(4) or 21(6)
must provide an annual report to the NICNAS Director stating the
name and volume of the chemical that was introduced in the relevant
year. Failure to comply is an offence with a maximum penalty of 10
penalty units ($1100) per day, up to a maximum of 120 penalty
units, and five time that for companies. New section
21AB provides that the NICNAS Director must maintain a
list of the chemical names and volumes reported under new
section 21AA and publish this list in the Chemical Gazette
at least once within a year of the annual new section
21AA reporting date.
Existing section 21Q sets out the object of the permit system
for low volume chemicals. This is one of the permit systems
referred to in both existing and new subsection
21(2). Item 63 amends paragraph 21Q(a) to
enable the quantity of chemicals introduced under a low volume
permit to be increased from 100kg to 1000kg in certain cases. As
mentioned in the Explanatory Memorandum,(23) the 1000kg
limit will only come into play where prescribed guidelines referred
to in new subsection 21U(2) have been
satisfied.
Item 64 adds new
subsections 21R(1A)-(1B) to allow easier renewal of low
volume permits that is, by administrative means rather than
requiring a new assessment process. Administrative renewal
applications will be subject to a number of conditions that must be
met to indicate that no new data is available in respect of the
chemical and the conditions of introduction have not significantly
changed. Under new subsection 21U(2A) (item 73),
an application to renew a low volume permit must be granted if the
NICNAS Director is satisfied that these conditions have been met
and section 21S has been complied with.
Item 72 inserts new subsection
21U(2). Apart from some stylistic changes to the existing
version, it also replaces the words the intended use of the
chemical does not constitute an unreasonable risk(24) to
health or to the environment with the intended use of the
chemical does not pose an unreasonable risk to occupational
health and safety, public health or the environment (emphasis
added). The Explanatory Memorandum provides no explanation for the
change, but the new phrase would seem to have a wider meaning, that
is, a wider range of detrimental effects must be considered by the
NICNAS Director in considering whether they should issue a low
volume permit.
Items 78-79 and 81 make a
similar change to item 72 in new
paragraphs 21W(1)(d)-(e) and subsection
21W(3). Section 21W allows low volume permits to be
subject to conditions.
Item 84 inserts new Division 1C in Part
3 (new sections 22A 22O) to introduce a controlled use
permit system. According to the Explanatory Memorandum, this:
provides an alternative to the assessment
certificate system in respect of industrial chemicals that are low
risk to occupational health and safety, public health and the
environment because of their highly controlled use, handling and
exposure. A person who makes an application for a controlled permit
under this new Division will also have to meet relevant
safeguards.(25)
Several safeguards are contained in new section
22C. Amongst other things, these require an applicant for
a controlled use permit to provide details about its proposed use,
a summary of its effects on occupational health and safety, public
health and the environment, and how much of the chemical the
applicant proposes to introduce over the next three years.
Regulations may also prescribe further information that is required
regarding controlled use permit applications. New section
22D also allows the NICNAS Director to request further
details about the above information. The Director must grant the
controlled use application under new section 22F
if he/she is satisfied that the various requirements in section 22C
have been complied with, and that the intended use of the chemical
does not pose an unreasonable risk to occupational health and
safety, public health or the environment. In making this decision,
the Director must have regard to the inherent nature of the
chemical, any guidelines prescribed in the regulations for the
purposes of this provision and any other matters that the Director
considers relevant. Again, a permit may be subject to conditions
set down by the NICNAS Director, including any considered by
him/her necessary or desirable to ensure that the use of the
chemical will not result in an unreasonable risk to occupational
health and safety, public health or the environment: new
section 22H. A holder must advise the NICNAS Director if
they become aware of any change of circumstances listed in
new subsection 22H(3), including if new relevant
data becomes available in respect of the chemical about its adverse
effects.(26) A maximum penalty of 300 penalty units
($33 000) applies (and five times that for companies) for an
offence of contravening a permit condition: new section
22I.
Item 85 inserts a new object and overview of
the assessment certificate system contained in Divisions 2 and 3 of
Part 3 of the Act. According to the Explanatory Memorandum:
the object and overview explains the difference
between the self-assessed system and the non-self assessed system,
where a NICNAS officer assesses the chemical. The new processes for
audited self-assessment of low regulatory concern chemicals are
contained in Division 2 and Division 3 of Part 3 of the Act. The
new audited self-assessment system allows introducers under the Act
to self-assess a chemical against criteria and guidelines issued by
NICNAS and/or prescribed by the regulations. This will introduce
flexibility into the current assessment process for industrial
chemicals to enable the fast tracking of low regulatory concern
chemicals while maintaining existing levels of worker safety,
public health and environmental standards.(27)
Item 87 inserts new section
23A, which provides an option for introducers of polymers
of low concern, non-hazardous chemicals and other chemicals or
classes of chemicals that are prescribed by the regulations, to
make an application for a self-assessed assessment certificate. In
comparison to existing section 23 (non-self assessed assessment
certificates), new section 23A does not list the
type of information required to accompany the application, but
states that the application must be in the approved form . Whether
this form is to set out in regulations is unknown. The information
requirements are important given that (see comments below in
relation to item 113) the self-assessment route is
only possible if NICNAS decides that the chemical does not pose any
possibility of unreasonable risk of adverse health effects, safety
effects or adverse environmental effects.
Items 98-103 amend various aspects of section
30A so as to revise the circumstances under which an early
introduction permit may potentially be issued. Currently, the
NICNAS Director must be satisfied that, amongst other things, the
prescribed criteria(28) relating to the environmental
effect of the chemical have been met and the introduction of the
chemical is consistent with the reasonable protection of
occupational health and safety, public health and the environment.
Under the proposed revised arrangements, the Director will
essentially need only to be satisfied that the chemical is classed
under the Act as a non-hazardous chemical, or polymer of low
concern, or otherwise prescribed in regulations. In relation to
early introduction permits, the Explanatory Memorandum
comments:
Under current legislation, chemicals that may be
of higher hazard but are of overall low risk to workers, the public
and the environment and are supported by a complete and sound data
package and effective exposure controls cannot qualify for an EIP
and cannot be introduced until the assessment certificate is
issued. The only other alternative for early introduction requires
Ministerial approval. This option is reserved for chemicals that
are needed in the national interest and is not a routine option for
most chemical introductions .
Members of the workforce will not be adversely
affected by the earlier introduction of the new chemical because
information on its potential hazards, risk control measures and the
permit status will be detailed on product Material Safety Data
Sheets (MSDS). This information will enable employers to conduct
risk analyses as required under current States OHS legislation. If
an EIP is granted, the hazard and risk information conveyed to
end-users will not differ from the information that will be
available when NICNAS assessment has been completed. This option
will only be available to chemicals with a complete data package
that can be used by introducers together with exposure scenarios to
implement appropriate risk control measures. The data package will
also be used by NICNAS to determine that the risk is appropriate to
allow early introduction of the chemical under
permit.(29)
Items 109-110 deal with time periods for
completing assessments in relation to applications for assessment
certificates. In particular item 110 inserts new
provisions that set out the time periods for completing assessments
for applications for both non-self assessed assessment certificates
(new section 31A) and self-assessed assessment
certificates (new section 31B). Under the new
self-assessment scheme, the assessment report, full public
report(30) and summary report are to be completed by the
NICNAS officer within 28 days after the day the application was
made(31) (assuming it is accepted under pre-screening
procedures see item 113 below). Where an
application is refused, the applicant must be notified of this
refusal within 28 days of the making of the application. The time
period for non self-assessed assessments under new section
31A(1) remains unchanged at 90 days. The Minister may
extend the time period for completing the applications by up to 90
and 28 days for non self-assessed and self-assessed assessment
applications respectively.
Item 113 inserts new sections
33A-33C. Where a person applies to the NICNAS Director for
a self-assessed assessment certificate under new section
23A (item 87), new section 33A requires a
NICNAS officer to pre-screen the application to determine (i)
whether the chemical is one that is potentially eligible for such a
certificate and (ii) whether the chemical poses any risk of adverse
health effects, safety effects or adverse environmental effects as
set out in section 32. If the application passes this pre-screening
which primarily requires the NICNAS officer to determine that there
is no possibility of unreasonable risk of section 32 adverse
effects occurring - the application becomes the section 31
assessment report, although the officer may include additional
information or recommendations to be incorporated as part of this
report: new section 33B. If the self-assessed
assessment application fails to pass pre-screening, reasons must be
given to the applicant: new section 33C.
Existing section 36 requires the NICNAS Director to give various
reports to an applicant for an assessment certificate once the
assessment report has been completed. Item 114
amends section 36 to include equivalent provisions in relation to
completion of a self-assessed assessment report, otherwise there
are no substantive changes. Reports for both categories of
assessments are published under existing section 38. Item
116 amends paragraph 38(3)(a) to provide that the Director
cannot publish a report until he/she has made a decision about any
application under section 25 or section 37. As noted by the
Explanatory Memorandum,(32) existing paragraph 38(3)(a)
only refers to a decision about an application under section
37.(33) Section 25 allows a person to request that the
NICNAS Director treat specified information contained in an
assessment application as exempt information for the purposes of
the Act. Given that section 25 is an existing section, it is not
clear why this change has been deemed necessary.
Item 124 inserts new Division 3B in
Part 3 (new sections 40K-40N) into the Act. These cover
the various obligations relating to commercial evaluation permits,
low volume permits, controlled use permits and self-assessed
assessment certificates.
Under new section 40K, all holders of these
permits and certificates are required to keep relevant records for
5 years. These records may be required to demonstrate the basis for
any statements made by holders in their applications for
permits/certificates. A failure to keep these records attracts a
maximum penalty of 120 penalty units ($13 200), and five times
that for companies. Under new section 40L, the
NICNAS Director may require all holders of these particular permits
and certificates to provide information to him or her in connection
with their application for, or application for renewal of, the
permit or certificate that they hold. A failure to provide this
information attracts a maximum penalty of 60 penalty units ($6600),
and five times that for companies. A standard clause relating to
self-incrimination is inserted by new section 40M.
Under this provision, the fact that the requested information might
tend to incriminate the person from whom it was requested cannot be
used as a reason for not providing it. However for criminal
proceedings the information (or any information or thing obtained
as a result of the information) can only be used as evidence in a
prosecution under new section 40L or under the
Criminal Code offences of providing false or misleading
information or documents.
Under new section 40N, holders of these permits
and certificates must give an annual report to the NICNAS Director
stating the name and volume of the chemical in question, together
with any adverse effect of the chemical on occupational health and
safety, public health or the environment. Failure to comply is an
offence with a maximum penalty of 10 penalty units ($1100) per day,
up to a maximum of 120 penalty units, and five times that for
companies.
Item 128 makes an amendment to requirements for
secondary notification(34) in existing section 64.
New paragraph 64(1)(a) provides that, if any
recommendations for secondary notification have been included in
the particulars noted by the NICNAS Director in the AICS listing of
the chemical, affected persons have notification obligations where
the circumstances included in the particulars occur.
Items 129 and 130 make similar
changes as in items 78-79 and 81
by replacing the phrase adverse health effects or adverse
environment effects with an adverse effect of the chemical on
occupational health and safety, public health or the environment in
new paragraphs 64(2)(d)-(e).
Items 133-166 amend existing Part 3A to require
mandatory company registration of all persons who introduce or
propose to introduce relevant industrial chemicals. The Explanatory
Memorandum comments that:
These changes are likely to improve industry
knowledge of NICNAS and compliance with the Act, as well as
maintaining public confidence in the regulatory scheme. In
extending the company registration provisions to cover all
introducers, those who introduce relevant industrial chemicals
below the threshold value (currently $500,000) per year will
continue to be exempt from company registration
charges.(35)
Those who do not pay the charge but introduce more
than the threshold value are required to provide the Director with
a final statement. The Director also has the power under the
amended subsection 80W(1) to request a written statement from any
person that the Director reasonably believes may have introduced a
relevant industrial chemical during the particular registration
year, indicating the value of the industrial chemicals that the
person introduced in that year. This will enable the Director to
identify situations where an unregistered person is required to be
registered and, in some cases, where an unregistered person is also
required to pay the company registration charge.
(36)
Items 167-173 amend various parts of existing
section 102 to update the list of decisions in the Act that are
subject to review by the AAT.
Item 182 inserts new sections 110B and 110C. New section
110C provides that the NICNAS Director must ensure that
the Chemical Gazette is made publicly available. This replaces the
current requirement in existing section 80Y that the Director must
use his/her best endeavours to provide a copy of each Chemical
Gazette to each registered person in each company registration
year.
Items 185-194 clarify that the various
definitions, new assessment and permitting systems, obligations etc
contained in the amendments listed in these items apply from the
date Schedule 1 commences.
Judging from the LRCC Taskforce report, the Explanatory
Memorandum to the Bill and other background material, the proposed
changes to the Act may bring considerable benefits to the plastics
and chemicals industry, particularly the smaller companies
operating in this sector.
The proposed self-assessment process is one of the major
measures aimed at securing such industry benefits by providing an
option that reduces both the cost and time required to get a
chemical assessed. However it is not clear if NICNAS has examined
whether, at least for some categories of non-hazardous and/or low
risk chemicals, it could reduce its fees and turn-around time for
assessment applications without the need to introduce the
self-assessment option. The LRCC Taskforce report suggests that the
self-assessment option will provide an incentive for industry
to
focus on the introduction of non-hazardous and/or
low risk chemicals thus providing benefits in terms of incentives
for introduction of safer and more environmentally friendly
chemicals.(37)
At this stage, it is unknown whether the Bill will be examined
by a Parliamentary Committee. It is recommended that it should be
subject to Committee review. At an absolute minimum, it is
suggested that a comprehensive oral briefing be obtained from
NICNAS setting out how in practice health and environmental risk
assessments will carried out in relation to proposed changes such
as the new self-assessment procedures. Clarification as to what
criteria will be used, including whether new regulations are to be
introduced, would be useful in this regard. Particularly if the
Bill does go to committee, views could also be sought from relevant
parties as to whether any self-assessment process is likely to
promote an increased focus by importers and manufacturers on
non-hazardous and/or low risk chemicals as claimed by the LRCC
Taskforce report.
The proposed introduction of a controlled use permit category is
a significant step. As mentioned earlier in this Digest, this is
intended to apply to:
chemicals that are low risk to occupational health
and safety, public health and the environment because of their
highly controlled use, handling and exposure.
It appears therefore that the appropriateness of having such a
category ultimately depends of whether the relevant chemicals are
handled, including during transport, in a way that genuinely
results in a low environmental and health risk. Whilst the Bill
does contain a range of safeguards designed to ensure that such
permits are only issued in appropriate cases, further information
on how this might operate in practice would be valuable.
The Explanatory Memorandum places great emphasis on various
accountability measures more public access to information,
increased requirements for record-keeping, mandatory registration
for chemical importers / manufacturers, and auditing by NICNAS. In
relation to NICNAS, the changes contained in the Bill are generally
characterised as improving NICNAS s focus on higher risk
introductions. Whilst the Explanatory Memorandum states that the
Bill should have minimal financial impact , it will be important
that NICNAS s ongoing ability to carry out and oversee the
accountability measures are adequately resourced. In this regard,
it is worth noting that the NICNAS cost recovery policy is to be
reviewed by Government in 2004-05.(38)
The LRCC Taskforce also made a number of recommendations
regarding community participation in NICNAS s decision process.
Amongst these were the creation of a community based consultative
forum and expanding NICNAS's public inquiry service. To the author
s knowledge, the Government has yet to make a commitment regarding
these recommendations.
Finally, given that this Bill may be accompanied by further
non-legislative reforms affecting the regulation of industrial
chemicals by NICNAS such as moves towards accrediting assessments
and approvals from Australia s developed world trading partners it
would be useful if some form of review of the entire reform package
was done in the medium term to ensure it is meeting stated
objectives.
-
The term industrial chemical is defined in section 7 of the Act.
The definition is complicated, but essentially it is a chemical
that has a use other than solely in the agricultural, veterinary,
therapeutic or food sectors.
-
Existing subsection 11(3). However, a footnote in the Act states
that subsection 11(3) is not intended to be an exhaustive
description of the effects or consequences of including a chemical
in the Inventory. There may be other consequences, express or
implied, because of other provisions of the Act.
-
See: http://www.nicnas.gov.au/obligations/new/05.htm
-
See:
http://www.nicnas.gov.au/obligations/registration/generalinfo.asp
-
An electronic version of the report (in two parts) can be
downloaded from
http://www.biotechnology.gov.au/content/controlfiles/display_details.cfm?ObjectID=1AEAD2E2-4AC2-45C0-A91DDDED687BC843
-
See: pp. 28 29 of the report.
-
See:
http://www.industry.gov.au/assets/documents/itrinternet/cp_govresponse.pdf
-
The response rejected to Steering Groups recommendation that
chemicals that were grandfathered from assessment by certain
Australian trading partners when they introduced their own chemical
regulations should not require full assessment/permitting for
introduction into Australia.
-
A list of Taskforce members is at page 33 of the Taskforce s
report.
-
See:
http://www.nicnas.gov.au/obligations/reform/pdf/FinalLRCCreportrecommendations-22June2003.pdf
-
More detail on organisations involved in various aspects of the
consultation is at pages 34 35 of the Taskforce s report.
-
This definition is effectively the same as a range of criteria
under which a permit for early introduction of a non-hazardous
chemical may be granted in existing section 30A.
-
p. 62.
-
If the Director knows the name and address of the person.
-
Decisions subject to AAT review are listed in existing section
102.
-
Such certificates are issued to the person introducing a
chemical once the chemical has successfully gone through the Part 3
assessment process.
-
Presumably commercial reasons may mean that newly assessed
chemicals are first listed on the confidential section of the
ACIS.
-
p. 63.
-
Where the commercial interest outweighs the public interest,
this is exempt information under section 75 of the Act.
-
pp. 15 16.
-
p. 66.
-
p. 66.
-
p. 69.
-
The term unreasonable risk is not defined in the Act.
-
p. 72.
-
The holder may be taken to become aware of a change of
circumstances if they ought reasonably to have been aware of them:
new subsection 22H(4)
-
p. 74.
-
These are prescribed in regulations.
-
pp. 13 15.
-
Under existing section 34, a public report consists of the
contents of the assessment report other than exempt information.
Exemption information is effectively defined in section 75 of the
Act.
-
Unless further information is required, in which case the 28 day
period starts again once the information is provided.
-
p. 78.
-
Section 37 allows the potential introducer of a chemical to
request the NICNAS Director to vary the assessment report on the
chemical in question.
-
For more information on the issue of secondary notification,
see: http://www.nicnas.gov.au/publications/pdf/handbook/chapter12.pdf
-
However, as NICNAS is a fully cost recovered scheme a small
annual administration fee (currently $336) will be required from
all those who register.
-
pp. 80 81.
-
op. cit, p. 21.
-
Explanatory Memorandum, p. 8.
Angus Martyn
20 May 2004
Bills Digest Service
Information and Research Services
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ISSN 1328-8091
© Commonwealth of Australia 2004
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