Commonwealth Numbered Regulations - Explanatory Statements
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AGRICULTURAL AND VETERINARY CHEMICALS CODE AMENDMENT REGULATIONS 2011 (NO. 1) (SLI NO 16 OF 2011)
EXPLANATORY STATEMENT
Select Legislative Instrument 2011 No. 16
Parliamentary Secretary for Agriculture, Fisheries and Forestry
Subject: Agricultural and Veterinary Chemicals Code Act 1994
Agricultural and Veterinary Chemicals Code Amendment Regulations 2011 (No. 1)
Subsection 6(1) of the Agricultural and Veterinary Chemicals Code Act 1994 provides, in part, that the Governor-General may make regulations prescribing matters required or permitted by the Agricultural and Veterinary Chemicals Code (the Code) to be prescribed by regulations within the meaning of the Code.
These Regulations amend the Agricultural and Veterinary Chemicals Code Regulations 1995 (the Principal Regulations) to support changes made to the Agricultural and Veterinary Chemicals Code Act 1994 by the Agricultural and Veterinary Chemicals Code Amendment Act 2010 (the Amendment Act). The Amendment Act will improve the efficiency and effectiveness of agricultural and veterinary chemicals regulation by the Australian Pesticides and Veterinary Medicines Authority (APVMA).
In part, the Amendment Act introduced reforms which:
* enabled applicants to make changes to chemical product labels without the APVMA's approval, if those changes do not affect the safe and effective use of a product;
* allowed applicants to follow a simplified process to effectively notify the APVMA of a limited range of defined, low-risk, minor variations to approvals or registrations; and
* effectively exempted the APVMA from the general prohibition on using confidential commercial information when considering applications for permits for minor use or emergency use.
To accompany the labelling-reform related amendments, the Regulations prescribe the particulars that are appropriate to be contained on the label for a container for a chemical product. These particulars are determined by the APVMA in its assessment of the application for label approval. The Regulations also prescribe conditions for the approval of a label.
To accompany the reforms to APVMA assessment of some low risk, minor variations to approvals or registrations, the Regulations specify the fee and time frame for determining applications by this application process. The Regulations also prescribe the information that is not to be included in the definition of confidential commercial information.
The APVMA was consulted closely over the requirements for and content of the Regulations. Members of the Product Safety and Integrity Committee (PSIC) were consulted over the content of the Regulations. PSIC advises the Primary Industries Ministerial Council on aspects of the National Registration Agreement for Agricultural and Veterinary Chemicals between the Commonwealth, state and territory governments.
The Office of Best Practice Regulation was consulted on the Regulations and has advised that no regulatory impact analysis, in the form of a Business Cost Calculator Report or Regulation Impact Statement (RIS) is required for this regulatory change (reference ID 11503).
A RIS was completed for the reforms which led to the amendments to the Agricultural and Veterinary Chemicals Code Act 1994 for which these Regulations are required. The Explanatory Memorandum for the Act contains the RIS and outlines the consultation undertaken for those reforms. The consultation completed for the Act has informed the development of the Regulations. On balance, the reforms were supported by agricultural and veterinary chemical stakeholders.
Details of the Regulations are set out below.
Regulation 1 - Name of Regulations
This regulation provides that the name of the Regulations is the Agricultural and Veterinary Chemicals Code Amendment Regulations 2011 (No. 1).
Regulation 2 - Commencement
This regulation provides for the Regulations to commence on the day after they are registered.
Regulation 3 - Amendment of the Agricultural and Veterinary Chemicals Code Regulations 1995
This regulation provides that the Agricultural and Veterinary Chemicals Code Regulations 1995 (the Principal Regulations) are amended as per Schedule 1 of the Regulations. The Schedule describes the amendments required to give full effect to several reform measures introduced on commencement of the Agricultural and Veterinary Chemicals Code Amendment Act 2010.
Schedule 1 - Amendments
Schedule 1 amends the Principal Regulations as follows:
Item [1] amends the definition of Code in subregulation 3(1) of the Principal Regulations to more clearly point the reader to the definition in the Act. (The Agricultural and Veterinary Chemicals Code is the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994.)
Item [2] inserts a definition of the current Poisons Standard into subregulation 3(1), the first of several items updating reference to what used to be called the Standard for the Uniform Scheduling of Drugs and Poisons.
Item [3] inserts a definition of labelling standard into subregulation 3(1) to be a standard determined for Regulation 18A which is applied to labels for containers for chemical products as a condition of label approval by regulation 18E.
Items [4] and [5] make changes to subregulation 3(1) required by amending references to the Standard for the Uniform Scheduling of Drugs and Poisons to the current Poisons Standard.
Item [6] inserts a note at the foot of subregulation 3(1) to point readers to the Act for several definitions of words and expressions used in the Principal Regulations.
Item [7] inserts a new regulation 3C to prescribe basic information about an application for a permit to be exempt from being confidential commercial information. The Code generally prohibits the disclosure of confidential commercial information, but provides for an exemption for information prescribed in the regulations.
Items [8], [10], [15], [18], [21], [28], [34], [40], [48], [50], and [52] to [54] update headings in the Principal Regulations to more accurately reflect the contents of divisions and subdivisions under those headings, in line with current best practice for legislative drafting.
Items [9], [11] to [14], [16], [17], [19] and [20] update the chapeaux for several regulations in new Subdivision 2.1.1 to reflect current best practice for legislative drafting. These amendments do not have any impact on the substance or effect of these regulations.
Item [22] amends the chapeau for subregulation 9(1) of the Principal Regulations to provide for separate regulations prescribing requirements for paragraphs 14(3)(d) and 29(1)(d) of the Code, in line with current best practice for legislative drafting.
Item [23] inserts a note pointing readers to the location of the regulation prescribing requirements for Code paragraph 29(1)(d) following amendments made by item [23].
Item [24] amends the chapeau for subregulation 11(1) of the Principal Regulations to provide for separate regulations prescribing requirements for paragraphs 14(3)(d) and 29(1)(d) and subsection 34A(1) of the Code, in line with current best practice for legislative drafting.
Item [25] amends paragraphs 11(2)(a) and (e) to change a reference to the Standard for the Uniform Scheduling of Drugs and Poisons to the current Poisons Standard.
Item [26] corrects an inaccuracy with paragraphs 11(2) (g), (h) and (j) of the Principal Regulations by omitting the requirement that a label make 'provision for' certain prescribed items. Making provision for something is not information for the purposes of subregulation 11(2). The matters previously dealt with in paragraphs 11(2)(g), (h) and (j) are now required to be included on the label by regulation 18D.
Item [27] omits regulation 11A and amends regulations 12, 13 and 14 of the Principal Regulations.
Regulation 11A declared that section 7 of the Act (which deals with orders) applied in relation to a label for containers for pool and or spa hypochlorites. The Agricultural and Veterinary Chemicals Code Order 1999 is no longer required and references to the order may be removed.
Regulation 12 is amended to provide for separate regulations prescribing matters for subparagraph 14(3)(g)(x), subsection 34A(1) and subparagraph 56E(1)(f)(x)of the Code to reflect current best practice for legislative drafting.
The wording of regulation 13 is amended to reflect current best practice for legislative drafting. This amendment does not have any impact on the substance or effect of this regulation.
Regulation 14 is amended to provide for separate regulations prescribing matters for paragraphs 14(5)(i) and 56E(2)(i) of the Code to reflect current best practice for legislative drafting.
Item [29] updates the chapeau for subregulation 15(1) of the Principal Regulations to reflect current best practice for legislative drafting. This amendment does not have any impact on the substance or effect of this subregulation.
Item [30] amends subregulation 15(2) of the Principal Regulations to reflect current best practice for legislative drafting and the changes made by item [29]. This amendment does not have any impact on the substance or effect of this subregulation.
Item [31] updates the chapeau for regulation 16 of the Principal Regulations to reflect current best practice for legislative drafting. This amendment does not have any impact on the substance or effect of this regulation.
Item [32] inserts a new regulation 17 into the Principal Regulations for the purposes of paragraph 21(2)(a) of the Code. Regulation 17 prescribes particulars that are appropriate to be contained on a label for containers for a chemical product. Prior to amendment, these matters would have been prescribed in regulation 11 under the incorrect head of power at paragraph 29(1)(d). The correct head of power for label particulars is paragraph 21(2)(a). The particulars prescribed in regulation 17 mirror those of regulation 11.
Item [33] inserts a heading for new Subdivision 2.1.4 in the Principal Regulations to more accurately reflect the content under that heading and amends the wording of regulation 18, to reflect current best practice for legislative drafting. This amendment does not have any impact on the substance or effect of this regulation.
Item [33] also inserts Subdivisions 2.1.5 and 2.1.6 into the Principal Regulations giving partial effect to the labelling reform measure. This item deals with the conditions of approval that are to apply to approvals of labels for containers for chemical products and which are prescribed in the regulations.
Subdivision 2.1.5, including new regulation 18A, empowers the Chief Executive Officer to make a labelling standard. This labelling standard is a legislative instrument which imposes requirements for labels for containers holding chemical product. Requirements may relate to the presentation and format of the label or the information contained on the label. Prior to the labelling reforms, the APVMA was required to approve every aspect of a chemical product label, including its format, colour, size and layout. Following the reforms the APVMA determines the particulars to be contained on the label, and sets out requirements for other aspects of the label in a labelling standard. Regulation 18E imposes the condition of approval that a label complies with the requirements of the labelling standard. Other conditions of approval mirror requirements of offences provisions in Part 4 of the Code. This introduces elements of a graduated compliance regime whereby breaches of conditions of approval that may also be an offence may be dealt with by suspension or cancellation of the approval under section 36 of the Code.
Subdivision 2.1.6, including new regulations 18B to 18I, sets out the conditions of approval for labels for containers for chemical products. Regulation 18B indicates that the conditions in this subdivision are prescribed for paragraph 23A(1)(a) of the Code and that the conditions apply to a label for containers for all chemical products.
Regulation 18C makes it a condition of approval that the label must be attached to the container before the supply of the product.
Regulation 18D requires that the label state the relevant particulars for the label, the batch number and the expiry and manufacture date of the product if applicable. This regulation mirrors the requirements of section 81 of the Code, including the provision that a permit issued by the APVMA may authorise behaviour that would otherwise breach a condition of approval. A permit may be issued, for example, to allow for a sticker to be placed over a relevant particular to update that particular with new information.
Subregulation 18D(2) also makes it a condition of approval that the label not contain information contrary to that required for the label, and subregulation 18D(3) requires that the information not be altered, defaced, obliterated, obscured or destroyed. In this, the regulation mirrors the requirements of subparagraph 86(1)(b)(ii) of the Code.
Regulation 18E requires that the label comply with the requirements of the labelling standard made for regulation 18A. If the labelling standard has not yet been made the label must comply with the relevant APVMA labelling code depending on whether the product is a veterinary or animal chemical product.
Regulation 18F requires that the label must not contain misleading or deceptive information about a particular on the label or about the use, safety, environmental impact, or efficacy of the chemical product.
Regulation 18F also requires that information must not accompany or be placed on the container if the information negates or varies, or qualifies or minimises the substance, purport or effect of information required to be stated on the label. In this, the regulation mirrors the requirements of subparagraph 86(1)(b)(iii) of the Code.
Regulation 18G mirrors the requirements of section 84 of the Code to not make claims about chemical products that are inconsistent with an instruction on the label for a container for the chemical product. This regulation applies to interested persons in relation to a label. Interested person is a term defined in section 3 of the Code.
Regulation 18H requires that an interested person in relation to a label must retain a copy of each form of a label and record information about the use of the label, including the batch number to which the label relates and the day the container on which the label is attached is first released for supply. This condition is made to ensure that records of the supply of chemical products to which a label is affixed are kept so that they may be provided to the APVMA, for example, for compliance activities, as required by regulation 18I.
Regulation 18I requires that an interested person in relation to a label must provide the copy of a form of the label and the information about its use, as required to be recorded by regulation 18H, to the APVMA on written request. The label and information must be provided to the APVMA within 10 days, or earlier if the APVMA believes it is necessary to receive the label or information to prevent imminent risk to public health or occupational health or safety.
Items [35], [36] and [38] update the chapeaux for subregulations 19(1) and 19(3) to reflect current best practice for legislative drafting. These amendments do not have any impact on the substance or effect of this regulation.
Item [37] updates the chapeau for subregulation 19(2) to reflect current best practice for legislative drafting and updates paragraph 19(2)(a) of the Principal Regulations to reflect changes in the Code relating to the process used by the APVMA to approve a label for a container for a chemical product. This paragraph is amended so that the matters recorded in the relevant APVMA file for paragraphs 21(2)(c) and (d) of the Code are included in notices provided for subsection 24(2), instead of a copy or sample of the label approved by the APVMA.
Items [39] updates paragraph 19(3)(b) of the Principal Regulations to reflect changes in the Code relating to the process used by the APVMA to approve a label for a container for a chemical product. This paragraph is amended in a similar way to the amendments made by item [37] so that the matters recorded in the relevant APVMA file for paragraphs 21(2)(c) and (d) of the Code are included in notices provided for subsection 24(2), instead of a copy or sample of the label approved by the APVMA.
Items [41] to [47] update the chapeaux for several regulations in new Subdivision 2.2.1 of the Principal Regulations to reflect current best practice for legislative drafting. These amendments do not have any impact on the substance or effect of these regulations.
Item [49] updates regulation 19A as a consequence of amendments made to subregulation 11(1) by item [24], removes reference to regulation 11A which is omitted by item [27], and removes reference to regulation 10 which was omitted by earlier amendments to the Principal Regulations. The chapeau is amended to reflect current best practice for legislative drafting.
Item [51] updates regulation 22 of the Principal Regulations as a consequence of amendments made by item [32] and by the recent amendments to the Code (which added section 23A). These amendments do not have any impact on the substance or effect of this regulation.
Item [51] also inserts new regulation 22AA into the Principal Regulations as a consequence of amendments to subregulation 11(1) and regulation 12 made by items [24] and [27] respectively. This regulation sets out the matters prescribed for subsection 34A(1) of the Code.
Item [55] inserts new regulation 23AB into the Principal Regulations as a consequence of amendments to regulations 12 and 14 made by item [27]. This regulation would set out the matters prescribed for subparagraph 56E(1)(f)(x) and paragraph 56E(2)(i) of the Code.
Items [56] and [57] update subparagraph 24(a)(iii) and paragraph 25(c) of the Principal Regulations to reflect changes in the Code relating to the process used by the APVMA to approve a label for a container for a chemical product. This paragraph is amended so that the matters recorded in the relevant APVMA file for paragraphs 21(2)(c) and (d) of the Code are included in notices provided for sub paragraphs 60(3)(a)(i) and (ii), instead of a copy of the label approved by the APVMA.
Item [58] omits paragraph 42(3)(b) from the Principal Regulations as there is no longer an Appendix L to the Poisons Standard. This amendment does not have any impact on the effect of this regulation.
Item [59] updates note 1 at the foot of subregulation 71(4) of the Principal Regulations as a consequence of making a new instrument for subsection 164(1A) of the Code.
Item [60] inserts a new item 13A into Part 2 of Schedule 6 to set out the time frame and fee applicable for applications made under section 26A of the Code to vary a relevant particular of an approval or registration. This amendment accompanies the reforms to APVMA assessment of some low-risk, minor variations to approvals and registrations.
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