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AGRICULTURAL AND VETERINARY CHEMICALS LEGISLATION AMENDMENT (ANIMAL FEED REFORM AND OTHER MEASURES) REGULATION 2015 (SLI NO 5 OF 2015)

 

EXPLANATORY STATEMENT

 

SELECT LEGISLATIVE INSTRUMENT NO. 5, 2015

 

 

AGRICULTURAL AND VETERINARY CHEMICALS LEGISLATION AMENDMENT (ANIMAL FEED REFORM AND OTHER MEASURES) REGULATION 2015

 
Issued by the authority of the Minister for Agriculture

 

Agricultural and Veterinary Chemicals Code Act 1994

 

Agricultural and Veterinary Chemicals (Administration) Act 1992

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


Table of Contents

Legislative authority for regulation. 3

Glossary. 4

OUTLINE.. 5

Amendments made. 5

Purpose of amendments. 5

Background. 5

National Registration Scheme. 5

Roles and responsibilities of the APVMA. 6

PUBLIC CONSULTATION.. 6

REGULATORY IMPACT ANALYSIS. 6

HUMAN RIGHTS COMPATIBILITY ASSESSMENT. 6

DETAILS OF THE AMENDMENT REGULATION.. 9

Schedule 1 - Amendments to the Agricultural and Veterinary Chemicals Code Regulations 1995 (Principal Code Regulations) 9

Administrative arrangements. 9

Transitional arrangements. 10

Excluded nutritional or digestive (END) products. 10

Schedule 2 - Amendment of the Agricultural and Veterinary Chemicals (Administration) Regulations 1995  14

Schedule 3 - Amendments to the Agricultural and Veterinary Chemicals Code Regulations 1995 (Principal Code Regulations) 14


Legislative authority for regulation

Subsection 6(1) of the Agricultural and Veterinary Chemicals Code Act 1994 (Code Act) provides, in part, that the Governor-General may make regulations prescribing matters required or permitted by the Schedule to the Code Act (the Agvet Code) to be prescribed by regulations within the meaning of the Agvet Code; or necessary or convenient to be prescribed by such regulations for carrying out or giving effect to the Agvet Code. The Agvet Code includes other provisions that provide specific authorities for matters to be prescribed in regulations. These authorities are specified in the particular regulation amendment in this explanatory statement.

Subsection 6(3) of the Code Act provides that the Governor-General may make regulations to exempt particular substances or chemical products from the operation of the Agvet Code, either conditionally or unconditionally.

Section 73 of the Agricultural and Veterinary Chemicals (Administration) Act 1992 (Admin Act) provides that the Governor-General may make regulations prescribing all matters required or permitted by the Admin Act.

Subsection 69C(1) of the Admin Act provides that if an active constituent for a proposed or existing chemical product, or a chemical product, is the subject of an international agreement or arrangement prescribed for the purposes of this section, the regulations may prohibit any one or more of the following: the import of the constituent or product into Australia; the manufacture or use of the constituent or product in Australia; any other dealing with the constituent or product in Australia; or the export of the constituent or product from Australia. The prohibition may be either absolute or subject to such conditions or restrictions as are prescribed.

Disallowance of Regulation

The Amendment Regulation is a disallowable legislative instrument for the purposes of the Legislative Instruments Act 2003 (LI Act). Section 54 of the LI Act means that the Amendment Regulation is not subject to sunsetting as the amendments to regulations in the Amendment Regulation are enabled by legislation that facilitates the establishment and operation of a scheme involving the Commonwealth and one or more states.


Glossary

The following abbreviations and acronyms are used throughout this explanatory statement.

 

Abbreviation

Definition

Admin Act

Agricultural and Veterinary Chemicals (Administration) Act 1992

Admin Regulations

Agricultural and Veterinary Chemicals (Administration) Regulations 1995

agvet chemical

agricultural chemical and veterinary medicine

Agvet Code

Schedule to the Code Act (see below)

Amendment Regulation

Agricultural and Veterinary Chemicals Legislation Amendment (Animal Feed Reform and Other Measures) Regulation 2015

APVMA

Australian Pesticides and Veterinary Medicines Authority

Code Act

Agricultural and Veterinary Chemicals Code Act 1994

END products

Excluded nutritional and digestive products

LI Act

Legislative Instruments Act 2003

NRS

National Registration Scheme for Agricultural and Veterinary Chemicals

OBPR

Officer of Best Practice Regulation

Principal Code Regulations

Agricultural and Veterinary Chemicals Code Regulations 1995

SNAC Order

Veterinary Chemicals Products (Excluded Stockfood Non-active Constituents) Order


OUTLINE

Amendments made

The Agricultural and Veterinary Chemicals LegislationAmendment (Animal Feed Reform and Other Measures) Regulation 2015 (Amendment Regulation) amends the Agricultural and Veterinary Chemicals Code Regulations 1995 (Principal Code Regulations) and the Agricultural and Veterinary Chemicals (Administration) Regulations 1995 (Admin Regulations).

Purpose of amendments

The Amendment Regulation amends the Principal Code Regulations to:

*       simplify existing regulations relating to whether animal feed products are declared to be, or not to be, veterinary chemical products;

*       provide that animal feeds that meet certain requirements for labelling, claims, ingredients and manufacture are not veterinary chemical products; and

*       make other amendments consequential to the amendments described above and to address typographical and administrative errors .

The Amendment Regulation also amends the Admin Regulations to provide that exporters wishing to export azinphos-methyl from Australia need to apply for a permit from the Australian Government Department of Agriculture.

Documents incorporated by reference

The Amendment Regulation includes measures that incorporate documents by reference. The documents are incorporated in new Division 3.2 of Schedule 3AA of the Principal Code Regulations and are:

*       Commonwealth legislative instruments under the Food Standards Australia New Zealand Act 1991; and

*       the standards and specifications of relevant associations, bodies or industry codes of practice relating to ingredients labelling or manufacture of animal feed.

Background

National Registration Scheme

Agricultural chemicals and veterinary medicines (together, agvet chemicals) are regulated through a cooperative National Registration Scheme for Agricultural and Veterinary Chemicals (NRS). The NRS is a partnership between the Commonwealth and the states and territories with an agreed division of responsibilities. Assessment and registration of agvet chemicals, as well as control of supply activities up to the point of retail sale, is undertaken by the Australian Pesticides and Veterinary Medicines Authority (APVMA) (a Commonwealth authority). Control of use of agvet chemicals after sale is the responsibility of individual states and territories.

The Code Act contains, as a schedule to it, the Agvet Code. Under the NRS, the Agvet Code operates, with the Agvet Code of each State, the Northern Territory and each participating territory (the Australian Capital Territory) to constitute a single national Agvet Code applying throughout Australia.

The Agvet Code, among other things, contains the detailed provisions allowing the APVMA to evaluate, approve or register and reconsider active constituents and agvet chemical products (and their associated labels). The provisions also allow the APVMA to issue permits and to licence the manufacture of chemical products. Other provisions in the Agvet Code provide for controls to regulate the supply of chemical products; and ensure compliance with and enforcement of the Agvet Code. 

Roles and responsibilities of the APVMA

The APVMA is responsible for administering and managing the parts of the NRS that oversee registration, quality assurance and compliance of agvet chemicals up to and including the point of retail sale. With input from other government agencies, the APVMA approves active constituents and registers chemical products, undertakes reconsiderations (reviews) of existing approvals and registrations and monitors compliance with legislative requirements for agvet chemicals up to and including the point of retail sale. The APVMA's regulatory functions are defined by the Administration Act, which establishes the APVMA; and the Agvet Code.

PUBLIC CONSULTATION

The reforms have been informed by extensive stakeholder consultation. Chemical industry groups, environmental organisations, primary producer associations, Commonwealth, state and territory agencies were all involved in discussions about reforms to animal feed regulation. Teleconferences and face to face meetings with interested stakeholders occurred over December 2013 to November 2014

Submissions were sought between 7 October 2014 to 7 November 2014 about an exposure draft of the particulars for the Amendment Regulation and a Regulatory Impact Statement for the reform. Fourteen submissions were received and considered.

The APVMA was consulted closely over the requirements for and content of the Amendment Regulation. Relevant state and territory agencies were also consulted on the regulations as part of the public consultation and comments provided were taken into account in preparing these regulations.

Comments from stakeholders resulted in the inclusion in the Amendment Regulation of amendments to provide for:

*       recognition of Australian feed ingredient standards

*       involvement of veterinary surgeons for specific use patterns and control of supply

*       additional listings of appropriate ingredients

*       recognition of industry codes of practice and international manufacturing accreditations

*       ingredient groupings consistent with international practice and Australian human food standards

*       clarity on the antibiotic substances that may be included as ingredients in products.

REGULATORY IMPACT ANALYSIS

The Office of Best Practice Regulation (OBPR) was consulted about these measures and has advised that the proposed regulatory changes required a regulation impact statement (ID number 16908). OBPR has considered the RIS and found it to be consistent with best practice.

HUMAN RIGHTS COMPATIBILITY ASSESSMENT

The Agricultural and Veterinary Chemicals Legislation Amendment (Animal feed Reform and Other Measures) Regulation 2015 (Amendment Regulation) is compatible with the human rights and freedoms recognised or declared under section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Legislative Instrument

The Amendment Regulation amends the Principal Code Regulations to:

*       simplify existing regulations relating to whether animal feed products are declared to be, or not to be, veterinary chemical products

*       provide that animal feeds that meet the requirements for labelling, claims, ingredients and manufacture are declared not be veterinary chemical products.

*       make other amendments consequential to the reforms and address typographical and administrative errors from early reforms.

The Amendment Regulation amends the Admin Regulations to provide that exporters wishing to export azinphos-methyl from Australia need to apply for a permit from the Australian Government Department of Agriculture.

Human rights implications

The Amendment Regulation engages the the right to health and a healthy environment (Article 12) in the International Covenant on Economic, Social and Cultural Rights (ICESCR). The United Nations Committee on Economic, Social and Cultural Rights has interpreted Article 12 to extend to the underlying determinants of health, including a healthy environment.

The right to health and a healthy environment

Schedule 1 of the Amendment Regulation engages and promotes the right to health in Article 12 of the ICESCR by restricting the substances that may be included as ingredients of products that may be supplied to food producing species without direct assessment by the APVMA. The restriction limits ingredients to ones recognized as appropriate for animal feeds having regard to the likelihood of residues that may impact human health.

Schedule 2 of the Amendment Regulation engages and promotes the right to health in Article 12 of the ICESCR by ensuring information be provided to countries trading in azinphos-methyl or products containing azinphos-methyl. This prior informed consent provides the opportunity to ensure appropriate controls exists for hazardous traded goods.

Other provisions

The Amendment Regulation includes a provision to address a technical error arising from previous amendments. This provision does not make any substantive change to the law and does not engage any rights.


Conclusion

The Amendment Regulation is compatible with human rights because it is promoting the right to health and a healthy environment through controlling ingredients of feed fed to food producing animal species.

 

The Hon. Barnaby Joyce MP, Minister for Agriculture


Agricultural and Veterinary Chemicals Legislation Amendment (ANimal feed reform and other measures) Regulation 2015

DETAILS OF THE AMENDMENT REGULATION

Section 1 - Name of Regulation

This section provides that the name of the regulation is the Agricultural and Veterinary Chemicals Legislation Amendment (Animal Feed Reform and Other Measures) Regulation 2015 (Amendment Regulation).

Section 2 - Commencement

This section provides that Sections 1 to 4 commence the day after this Regulation is registered.

This section provides that the measures in Schedule 1 commences on 5 March 2015.

This section provides that the measures in Schedules 2 and 3 commence the day after this Regulation is registered

Section 3 - Authority

This section specifies that this Regulation is made under the authority in the Agricultural and Veterinary Chemicals Code Act 1994 (Code Act) and the Agricultural and Veterinary Chemicals (Administration) Act 1992 (Admin Act).

Section 4 - Schedules

This section provides that each instrument in a Schedule to this Regulation is amended as described in the Schedule.

Schedule 1 - Amendments to the Agricultural and Veterinary Chemicals Code Regulations 1995 (Principal Code Regulations)

Administrative arrangements

Items 1, 3, 5 to 13 and 17 - Subregulation 8(2), regulation 78C, clause 1 of Schedule 3AA, clause 2 and 3 of Schedule 3AA, Part 2 of Schedule 3AA, Part 3 of Schedule 3AA, Part 2 of Schedule 6

Items 1, 3, 10, 11, 13 to 15 amend the Principal Code Regulations consequential to amendments in item 16, described below.

Item 5 clarifies certain terms defined in the Principal Code Regulations.

Items 6 and 8 repeal definitions superseded by the introduction of a definition introduced by item 16. This has the effect of simplifying the regulation of animal feeds as veterinary chemical products. Item 9 repeals the provisions relating to prescription of stockfood non-active constituents, and daily requirements, both superseded with the introduction of the reform to animal feed products in item 16.

Item 7 introduces definitions to support amendments made in item 16.

Item 12 repeals provisions declaring direct fed microbials and stockfood non-active constituents, independent of claims, to be veterinary chemical products. Direct fed microbials and stockfood non-active constituents are to be treated as all other prospective constituents of substances or mixtures of substances that may be veterinary chemical products.

Item 17 sets out the fee and assessment timeframes applicable for applications for ingredient determination.

Confidential commercial information

Item 2 - Regulation 69AAA

Item 2 introduces offences to disclose, or further disclose, confidential commercial information (CCI) about substances or mixtures of substances, or ingredients of substances or mixtures of substances given to the APVMA in connection with an application under the Principal Code Regulations. For example, with an application for an ingredient determination under Division 3.3 of Part 3 of Schedule 3AA--see item 16 below.

The provisions work by applying the provisions of the Agvet Code about disclosure of CCI at section 162, with the modifications necessary, to the disclosure. The maximum penalty for an offence committed against the regulations introduced in item 2 is 50 penalty units, the maximum amount permitted by paragraph 6(2)(i) of the Code Act.

Item 2 ensures that confidential commercial information provided to the APVMA in connection with an ingredient determination application has the same protection from disclosure as if that information had been provided with an application under another provision of the Agvet Code.

Transitional arrangements

Item 4 - Division 10.4 of Part 10

Item 4 introduces Division 10.4 of Part 10 which sets out transitional arrangements.

Regulation 88 provides that ingredients currently listed in the Veterinary Chemicals Products (Excluded Stockfood Non-active Constituents) Order (SNAC Order) are taken to be ingredients permitted in END products until ingredient determinations for those ingredient are made under Division 3.3 of Part 3 of Schedule 3AA. The  ingredient determinations for all ingredients in the SNAC Order must be made by 5 June 2015 and must authorise all existing uses of an ingredient permitted under the SNAC Order..

Regulation 90 repeals Division 10.4 after 12 months once all actions prescribed have been completed.

Excluded nutritional or digestive (END) products

Item 16 - Part 3 of Schedule 3AA, Division 3.2                        

This item introduces Division 3.2 into Part 3 of Schedule 3AA of the Principal Code Regulations. Part 3 of Schedule 3AA sets out substances or mixtures of substances that are declared, for paragraph 5(4)(b) of the Agvet Code, not to be veterinary chemical products.

Clause 4 defines certain animal feeds, for both stock and companion animals, as excluded nutritional and digestive (END) products. As a result, END products are not veterinary chemical products and do not require registration before they may be supplied and used.

As defined, an END product is a substance or mixture of substances intended for consumption by an animal that meets certain requirements for ingredients, claims, labelling and manufacture. Each requirement sets out an acceptable level of risk for each of the four aspects of the END product. Together, the requirements describe animal feeds of defined and well understood risk that do not require pre-market access assessment and registration.

This item also recognises that animal safety and welfare may be impacted by the method through which a food is introduced for consumption by the animal. Some methods require a degree of veterinary experience or animal husbandry that is not present within the wider community. Products that are introduced directly to an animal's digestive tract, such as by intraruminal bolus, syringe or stomach tubing to the gut, are not END products.

The clause also clarifies that products declared to be veterinary chemical products cannot also be END products. Where the risk of a product is sufficient to warrant specific direction in law for an assessment by the APVMA this will continue.

Ingredients requirements of END products

Clause 5 sets out the ingredients requirements for END products.  All ingredients of END products must either be of plant or animal origin and edible by an animal or authorised for use in particular country for the purpose for which it is used in the END product. Where the authorisation for the use of that ingredient specifies a purpose for that ingredient, use of the ingredient in the END product is restricted to that purpose.

The ingredients requirements draw upon a common overseas approach to animal feeds, where lists of suitable ingredients, their purpose and quality, are prepared for the reference by manufacturers and suppliers. The requirement provides for the inclusion in END products only suitable ingredients referenced in specific instruments from a range of jurisdictions including the United States of America, the European Union and New Zealand. Section 6(3)(a) of the Code Act provides that the Principal Code Regulations may adopt wholly or partly, and specifically or by reference, any standards, rules, codes or specifications of any association, body or institution.

As the overseas references may be amended from time to time, they apply as made or published at the time of the supply of the product. This will ensure Australia remains current with international practice in its approach to animal feed ingredients. Section 6(3)(a) of the Code Act also provides that references may be adopted from time to time. The ingredient references are publicly available, most at no charge. Where a cost to access the reference does exist, the value of the ingredients contained therein to the animal feed industry is considered sufficient to warrant the inclusion of that reference in subclause (5)(3). Nothing requires any animal feed manufacturer or supplier to access a fee-for-access reference.

Paragraphs (5)(4)(a) and (b) provide that  ingredients for which an assessment process for listing overseas is not complete are not permitted to be used in END products until the ingredient's suitability finally determined.

Ingredients may also be included in END products according to domestic authorisations for additives suitable for human consumption maintained by Food Standards Australia and New Zealand. As well, the Australian Pesticides and Veterinary Medicines Authority (APVMA), the regulator of veterinary chemical products supplied in Australia, must maintain a specific animal feed ingredient legislative instrument (an ingredient determination) in which Australian specific permitted ingredients are listed.

Subclause (5)(6) sets out ingredients that must not be included in END products to maximise the safety of the products and minimise risk to trade and antibiotic resistance. These prohibited ingredients include hormones or vertebrate animal material for consumption by ruminants. Antibiotic ingredients that have a restricted access due to their listing in the Poisons Standard are not permitted and those listed as a poison under Schedule 6 of the Poisons Standard may only be included for the purpose of a preservative in the feed. The APVMA may also, by legislative instrument, determine ingredients that are not to be included in END products.

Feed ingredient quality and the potential presence of impurities is a source of risk for animal welfare, human health and to international trade. This is addressed by a cascade of quality specifications, falling from an Australian national standard, to a standard by an Australian state or territory to the most stringent standard (if more than one exists) referenced for the authorised ingredient. In the case of live bacterial ingredients, such as probiotics or direct fed microbials, where a specific strain of that ingredient is listed, that strain is taken to be part of the minimum quality for that ingredient.

Claims requirements of END products

The claims requirements for END products set out at clause 6 provides for the management of risk to animal safety and welfare by substantiation of the claims for the product through scientific studies (published, or of a publishable quality, or within a European Union directive relating to claims for animal nutrients) or the application of a veterinary surgeon's professional judgement.

END product claims to alleviate or prevent a disease or condition in the animal or to modifying the physiology of the animal are possible only if they may be substantiated by scientific studies or on the judgement of a veterinary surgeons. Claims about a product's ability to cure a disease or condition may be made only if the END product is supplied by, or on the instructions of, a veterinary surgeon, consistent with state and territory law about the prescribing rights of veterinary surgeons.

The reliance on supply of END products with particular claims only by, or according to the instructions of, veterinary surgeons recognises their professional expertise to manage risks to the welfare of animals under their care, consistent with the laws that govern the practices of veterinary surgeons.

Labelling requirements of END products

The labelling requirements for END products at clause 7 ensure that sufficient information is available to allow purchasers and users of END products to make informed choices about the product. Information on the safe handling, ingredients, key analysis, poisons information and first aid instructions must accompany the supply of the product.

Clause 7 recognises that modern communication methods provide for differing means of presenting the required information. The required information may be presented, for example, through a website where the website details are provided with the product.

Where claims about a product are substantiated through the European Union directive the requirements for labelling from that directive also apply.

Manufacturing requirements of END products

The Principle Code Regulations provide for the majority of veterinary chemical products to be manufactured at licensed facilities or at facilities that have been audited to comply with good manufacturing principles. The need for quality assurance in chemical products for animals reflects potential risks to both animal and human health from poor manufacturing practices.

The manufacturing requirements at clause 8 provide for these risks to be managed by requiring END products be manufactured in accordance with one of a range of quality assurance regimes. Where a regime requires independent auditing for accreditation this must be completed.

The first acceptable regime is the existing APVMA manufacturing licensing system. The second is reliance on an applicable industry code of practice such as the Feed Ingredients and Additives Association of Australia for stock food products or Australian Standard AS5812-2011, developed by the Pet Food Industry Association of Australia for pet food manufacture. Lastly the manufacturing requirements may also be addressed through conformance with the requirements of a member state of the European Union (such as through certification under the Quality and Safety System for Specialty Feed Ingredients and their Mixtures, FAMI-QS) or the United States of America.

Many non-medicated blocks and licks are currently declared not to be veterinary chemical products and are therefore not subject to manufacture requirements. Although these blocks and licks may be END products, they are not obliged to conform to a manufacturing standard.

 

Item 16 - Regulations Part 3 of Schedule 3AA, Division 3.3

Item 16 also introduces Division 3.3 into Part 3 of Schedule 3AA of the Principal Code Regulations.

Division 3.3 provides for the APVMA to make ingredient determinations described at clause 9 that authorise the use of ingredients in one or more classes of END products (see item 8 in the table at subclause (5)(3). Ingredient determinations are made by legislative instrument and can apply to one or more ingredients or classes of ingredients. Consistent with the other references about permitted ingredients, the ingredient determination may authorise use of the ingredient only for a specific purpose and may make other requirements. An ingredient determination can be made on application or on the APVMA's initiative. The APVMA must publish ingredient determinations on its website.

In making an ingredient determination the APVMA must be satisfied the inclusion of the ingredient in an END product would not: be unduly hazardous to people; be likely to be harmful to people; have unintended effects harmful to people, animals or the environment; or unduly prejudice trade. If the APVMA is not satisfied of these matters it can revoke or vary a previous determination it has made. The ingredient determination must have regard to specific matters that inform that decision, including the toxicity of the ingredient or its residues, the poison classification, and the composition of the ingredient. The APVMA may also have regard to other matters that it thinks relevant. This ensures that the ingredient determination is made on the best available science. The APVMA must consider the trade matter only to the extent that trade is relevant to the ingredient. For example, full regard must be had to the trade matter for ingredients to be included in cattle feed but the trade matter is not likely to be relevant for pet food.

Clause 10 introduces an application process to the APVMA for ingredient determinations that operates consistent with other application processes in the Agvet Code. Subregulation (10)(6) provides that several provisions of the Agvet Code apply to ingredient determination applications. Other provisions of the Agvet Code also apply to ingredient determination applications as they are applications under the Code (see for example subsections 164(1) and 165(1)).

Clause 11 provides for information that may or may not be used in making an ingredient determination by the APVMA. Overseas trials and experiments and consultation consistent with other provisions of the Agvet Code and Admin Act could be relevant to the APVMA's decision on the determination.

Subclauses (11)(2) to (5) limit the use APVMA may make of information given in relation to an ingredient determination application in a similar way to the way it is prevented under Division 4A of Part 2 of the Agvet Code from using information given to it with an application under sections 10 or 27 or under section 161. Subclause 11(6) limits the use of information given in relation to an ingredient determination for three years consistent with veterinary chemical products protections under Division 4A of Part 2 of the Agvet Code.

 

Schedule 2 - Amendment of the Agricultural and Veterinary Chemicals (Administration) Regulations 1995

Item 1 - Part 2 of Schedule 1

This item inserts a new item 3AA after item 3 of Part 2 of Schedule 1 to the Agricultural and Veterinary Chemicals (Administration) Regulations 1995, for azinphos methyl (IUPAC name: S-(3,4-dihydro-4-oxobenzo[d]-[1,2,3]-triazin-3-ylmethyl)-O,O-dimethyl phosphorodithioate; CAS number: 86-50-0).

 

The amendment provides that the export of azinphos-methyl is prohibited except if written permission (in the form of a permit) is granted by the Department of Agriculture. There is no change to the importation control on azinphos-methyl.

 

Schedule 3 - Amendments to the Agricultural and Veterinary Chemicals Code Regulations 1995 (Principal Code Regulations)

Items 1 to 5 - Subregulations 8B(2), 15(1), 41(2), 41(3) and Regulation 47AB

Items 1 to 5  make technical amendments to address typographical errors arising from previous amendments to the Principal Code Regulations.

 


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