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2008-2009-2010
THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA
HOUSE OF REPRESENTATIVES
AGRICULTURAL AND VETERINARY CHEMICALS CODE AMENDMENT BILL 2010
EXPLANATORY MEMORANDUM
(Circulated by authority of the Minister for Agriculture, Fisheries and
Forestry,
the Hon. Tony Burke MP)
AGRICULTURAL AND VETERINARY CHEMICALS CODE AMENDMENT BILL 2010
GENERAL OUTLINE
The Agricultural and Veterinary Chemicals Code Amendment Bill 2010 (the
Bill) consists of two measures and will amend the Schedule to the
Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code). The Bill
seeks to improve the efficiency of the registration processes of the
Australian Pesticides and Veterinary Medicines Authority (APVMA), without
jeopardising human health or the environment.
The Bill provides for:
. the APVMA being effectively exempted from the general prohibition on
using confidential commercial information when registering a permit for
minor use or emergency use; and
. trade issues being considered when addressing the adequacy of product
labels by extending the definition of "adequate".
Confidential commercial information
The Bill provides for an exemption to the general prohibition on the
disclosure of confidential commercial information (CCI) in relation to
consideration of minor use or emergency use permits. Currently, all matters
about a permit application, including the fact that an application has been
made, are considered CCI. This means the APVMA cannot discuss the permit
application with the product registrant, or any other person who might be
able to provide relevant information, without first obtaining the permit
applicant's consent and operating within the parameters of section 162 of
the Agvet Code. This arrangement is administratively cumbersome.
Any person can make a permit application to extend the use of an existing
registered product. Permit applications are often made by individual
farmers or grower organisations. In some cases several persons or
organisations may make an application for a permit to use the same product.
Under the current legislation, it is very difficult for the APVMA to
disclose that it has received multiple applications and streamline the
application process.
The amendments would enable the APVMA to efficiently liaise with all
applicants with a view to combining the requests into a single application.
The amendments will also enable the APVMA to contact the registrant, or
consult with any person who is likely to have information (scientific data
or otherwise) that would be relevant to the APVMA's assessment to decide
whether to grant the permit. Without this information the APVMA may not
have sufficient information on which to assess the application and
ultimately to issue the permit. This would increase the efficiency of the
APVMA's process for assessing and issuing permits.
Applications for minor use or emergency use permits do not ordinarily
contain commercially valuable information. However, in the event that such
information is included, the Bill foreshadows regulations which will
specify the types of information that APVMA needs to release in relation to
undertaking its assessment of the application. Other information will
remain CCI.
The regulations would mirror a subset of the disclosure requirements for
product applications currently set out in regulations 8C, 8D and 8E of the
Agricultural and Veterinary Code Regulations 1995 (the Regulations).
The amendments would only apply to minor use or emergency use permits.
Details of research permits-which are commonly used by chemical companies
during product development-including the fact that they have been made,
would rightfully remain protected, as this is commercially sensitive
information.
Trade issues
The Bill also seeks to include trade issues as a consideration when
deciding on the adequacy of product labels-which include instructions for
proper use-by extending the definition of "adequate" to include trade
aspects. The APVMA is currently required to consider trade when determining
whether to grant or refuse an application, but not when approving a label.
Instructions (specified on the product label) ensure that proper use of the
product will not adversely affect Australia's exports. However, over time
issues may arise that require changes to the label to update the
instructions. For example, trade concerns can arise where an importing
country reduces its maximum residue limit or establishes a zero tolerance.
If this happens the use of the product in accordance with the label will
result in a residue violation in that country. This sort of trade concern
can be addressed by an instruction on the label. Currently, to update the
label instructions to address a trade-only issue, the APVMA must take
regulatory action against the product registration. Only then can it update
the label as a related action. The APVMA lacks the power to directly take
action against the source of the concern, namely the product label.
The Bill seeks to address this problem by enabling the APVMA to focus the
regulatory action upon the label approval when concerns about trade issues
arise without unnecessarily affecting the registration of the product.
The Bill does not include consequential amendments to other Acts.
FINANCIAL IMPACT STATEMENT
The amendments have been assessed as having no significant financial impact
on the Australian Government and affected parties.
AGRICULTURAL AND VETERINARY CHEMICALS CODE AMENDMENT BILL 2010
NOTES ON CLAUSES
Clause 1: Short title
This clause is a formal provision specifying the short title of the Act as
the Agricultural and Veterinary Chemicals Code Amendment Act 2010.
Clause 2: Commencement
This clause provides that the Act will commence on the day after it
receives the Royal Assent.
Clause 3: Schedule(s)
This clause provides that each Act that is specified in a Schedule to the
Act is amended or repealed as set out in the applicable items of the
Schedule concerned, and any other item in a Schedule to the Act has effect
according to its terms.
SCHEDULE 1--Amendment of the Agricultural and Veterinary Chemicals Code Act
1994
Item 1: Section 3 of the Schedule
This item splits section 3 into two subsections.
Item 2: Section 3 of the Schedule (at the end of the definition of
adequate)
This item amends the definition of "adequate" by adding paragraph (d) so
that it extends to trade concerns. Paragraph (b) mirrors the statutory
criterion relating to trade in subparagraph 14(3)(e)(iv) of the Agvet Code
and other provisions in the Agvet Code which require the APVMA to have
regard to trade concerns when considering and reconsidering product
registrations.
The purpose and intention of the new paragraph (d) is to enable the APVMA
to have regard to trade concerns when assessing or taking other regulatory
action such as a reconsideration under section 34 or 34A or a suspension or
cancellation under section 41 in respect of label approvals.
Item 3: Section 3 of the Schedule (at the end of the definition of
confidential commercial information)
This item inserts two new paragraphs into the definition of "confidential
commercial information". Paragraph (d) excludes from that definition the
fact that an application has been made for a permit for the use of an
active constituent for a proposed or existing chemical product, or for the
use of a chemical product if the proposed use of the product is a minor use
or emergency use.
Paragraph (e) excludes from the definition of "confidential commercial
information" prescribed information relating to the making of a minor use
or emergency use permit application.
By implication, a permit for an active constituent for a proposed or
existing chemical product, or for the use of a chemical product if the
proposed use is for the purposes of research will continue to come within
the definition of "confidential commercial information". This extends to
the fact of an application having been made for such a permit.
Paragraphs (d) and (e) are intended to exclude certain information from the
operation of section 162 of the Agvet Code which governs the disclosure of
confidential commercial information. Without those constraints, the APVMA
will be able to disclose certain information about such permits, including
the fact of the application having been made, to the person in whose name
the product is registered or other persons who could inform the APVMA's
assessment of that process.
Item 4: Section 3 of the Schedule
This item inserts into section 3 a definition of 'emergency use' by
reference to the definition in the Regulations.
Item 5: Section 3 of the Schedule
This item inserts into section 3 a definition of 'minor use' by reference
to the definition in the Regulations.
Item 6: At the end of section 3 of the Schedule
This item inserts a new subsection 3(2) providing that a regulation
prescribing information for the purposes of paragraph (1)(c) of the
definition of "confidential commercial information" is a legislative
instrument.
Item 7: Subsection 162(13) of the Schedule
This item repeals and substitutes subsection 162(13).
Paragraph (a) of the new subsection 162(13) clarifies that a reference in
that section to information about an active constituent for a proposed or
existing chemical product, or about a chemical product, includes a
reference to the fact of an application having been made.
Paragraph 162(13)(a) operates in conjunction with subsection 162(1), so
that the information described in paragraph (a) remains confidential. That
confidentiality can, however, be lost upon the application passing
preliminary assessment when certain information about the application must
be published in accordance with section 11B or 28B of the Agvet Code as
appropriate to the application.
Paragraph (b) of the new subsection 162(13) provides that a reference in
that section to information about an active constituent for a proposed or
existing chemical product, or about a chemical product, includes a
reference to the fact of an application having been made.
The intention of paragraph (b) is to operate in conjunction with the
amended definition of "confidential commercial information" to exclude from
the operation of section 162 the fact of a permit application having been
made where the proposed use of the product is a minor use or emergency use.
It is also intended to exclude from the operation of section 162 prescribed
information about the making of such a permit.
The purpose of the new paragraph (b) is to enable the APVMA to disclose
some details about the permit application, including the fact of an
application having been made, to the product registrant and others who
might have relevant information to inform the assessment of the permit
application. It is intended that such disclosure be able to occur outside
the constraints of section 162 which require obtaining the permit
applicant's consent as well as ensuring that the recipient continues to
protect the confidentiality of the information in accordance with
subsection 162(6) of the Agvet Code.
Item 8: Application
This item confirms that the amendment to the definition of "adequate" in
item 2 applies to applications for approval for containers for a chemical
product made under section 10 of the Agvet Code and applications to vary
the relevant particulars or conditions of label approval for containers for
a chemical product under section 27 of the Agvet Code made on or after the
commencement of this amendment.
The item also confirms that the amendment in item 2 applies to a
reconsideration of a label approval under section 34 if at least one of the
actions described in subparagraphs (i) - (iii) has occurred, to a
reconsideration under section 34A of the Agvet Code that began before
commencement of the amendment, and to a standard for a chemical product
already submitted to the Minister under section 56D of the Agvet Code on or
after commencement of this amendment.
This item also confirms that the amended definition of "confidential
commercial information", which excludes certain information relating to
permits for minor use and emergency use as set out in items 3 to 7, applies
whether the application is made on or after the commencement of these
amendments.