Defence Coalition Against RCD Inc v Minister for Primary Industries & Energy

[1996] FCA 925

CATCHWORDS

EQUITY - injunctions  - registration of Rabbit Calicivirus Injection - whether decision to register can be restrained - whether serious question to be tried - whether arguable decision to register reached unreasonably - availability of review on merits.

Administrative Decisions (Judicial) Review Act 1977 (Cth), s5(1), s10(2)(b)(ii)
Agricultural and Veterinary Chemicals (Administration) Act 1992 (Cth)
Agricultural and Veterinary Chemicals Act 1994 (Cth)
Agricultural and Veterinary Chemicals Act 1995 (WA)
Agricultural and Veterinary Chemicals Code Act 1994 (Cth), s1, s3, s4, s5, s10, s12, s12(2), s13, s14, s14(2), s14(3), s14(3)(e)(iii), s14(3)(f), s31, ss35-46, s41(1), s167(1)(b), s168, s168(2)
Biological Control Act 1984 (Cth)
Environment Protection (Impact of Proposals) Act 1974 (Cth)
Federal Court of Australia Act 1976 (Cth), ss19 and 23

Australian Conservation Foundation v The Commonwealth (1980) 146 CLR 493
Castlemaine Tooheys Ltd v South Australia (1986) 161 CLR 148
Onus v Alcoa of Australia Ltd (1982) 149 CLR 27
R v HM Inspectorate of Pollution and Anor; Ex Parte Greenpeace Ltd [1994] 1 WLR 570

DEFENCE COALITION AGAINST RCD INC v MINISTER FOR PRIMARY INDUSTRIES AND ENERGY
NO WG 154 OF 1996

R D NICHOLSON J
PERTH
23 OCTOBER 1996

IN THE FEDERAL COURT OF AUSTRALIA            )

WESTERN AUSTRALIA DISTRICT REGISTRY       )

GENERAL DIVISION  )                   NO WAG 154 OF 1996

B E T W E E N:  DEFENCE COALITION AGAINST RCD INC

Applicant

and

MINISTER FOR PRIMARY INDUSTRIES AND ENERGY

Respondent

MINUTE OF ORDER

JUDGE MAKING ORDER: R D NICHOLSON J

DATE OF ORDER:               23 OCTOBER 1996

WHERE MADE:                   PERTH

THE COURT ORDERS THAT:

(1)Paragraph 2 of the applicant's notice of motion be refused;

(2)the applicant pay the costs of the respondent on the hearing of that paragraph of the motion, including the costs on 18 October 1996.

Note:Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.

IN THE FEDERAL COURT OF AUSTRALIA            )

WESTERN AUSTRALIA DISTRICT REGISTRY       )

GENERAL DIVISION  )  NO WG 154 OF 1996

B E T W E E N  DEFENCE COALITION AGAINST RCD INC

Applicant

and

MINISTER FOR PRIMARY INDUSTRIES AND ENERGY

Respondent

CORAM:R D NICHOLSON J

DATE:23 OCTOBER 1996

PLACE:PERTH

REASONS FOR JUDGMENT

The notice of motion before the Court raises two principal issues.  The first is whether the National Registration Authority for Agricultural and Veterinary Chemicals ("NRA") established by the Agricultural and Veterinary Chemicals (Administration) Act 1992 (Cth) should be joined as a party to this proceeding. The second is whether the applicant should be granted an interlocutory injunction to restrain the operation of the decision of the second respondent to register the product Rabbit Calicivirus Injection under the provisions of the Agricultural and Veterinary Chemicals Code Act 1994 (Cth) ("Agvet Code Act") .  That registration was effected on 16 September 1996.

Joinder

On the question of joinder, the applicant submits the case it has brought in respect of the respondent as the Minister responsible under the Biological Control Act 1984 (Cth) and an action which it proposes to bring under the Environment Protection (Impact of Proposals) Act 1974 (Cth) all raise common issues of fact and are so intertwined with the action it
seeks against the NRA, that joinder should be granted.  Counsel for the respondent, who also appears on behalf of the NRA, objects to joinder on the ground the action against the NRA involves a different statutory regime to that against the respondent.  To some degree resolution of the necessity to join the NRA is dependent upon resolution of the question whether the applicant has standing against either the respondent or any other party joined.  In my opinion, in those circumstances it would be preferable for par1 of the motion raising the issue of joinder to be stood over to the next directions hearing in order the issue can be considered at the same time as the issue of standing.  Furthermore, this may allow the issue to be considered in the light of these reasons.

Standing

The question of standing was raised from the Bench today and consequently counsel for the respondent has not had opportunity to prepare argument on it.  The applicant is represented by a person not legally qualified.  His attention has been drawn to the dicta in Australian Conservation Foundation v The Commonwealth (1980) 146 CLR 493 at 530‑531 and in Onus v Alcoa of Australia Ltd (1982) 149 CLR 27 at 36. If the issue of standing is to be resolved in this proceeding it may require an opportunity for the applicant to file further evidence. The only evidence concerning the applicant before the Court at present is drawn from exhibited material in a newsletter of the applicant said to be based upon the corporate documents of the applicant. It is therefore not appropriate this issue be resolved on this motion and it should be stood over for later resolution.

Evidence

The evidence before the Court on behalf of the applicant has been prepared diligently by its present advocate.  It consists of an affidavit sworn in October 1996 filed on 10 October 1996, a supplementary affidavit sworn on 18 October 1996 and a further affidavit sworn on 22 October 1996.  In addition, the case for the applicant has relied upon Answers to Respondents Requests for Particulars and Supplementary Answer to Respondent's Requests for Particulars.  Much of the evidence brought by the applicant relates to the case it seeks to bring in the Substituted Amended Application in respect of a
declaration under the Biological Control Act in respect of rabbit calicivirus.  On behalf of the respondent no objection is taken to the use of that evidence on this interlocutory application in respect of the injunctive proceedings sought in relation to the relevant decision under the Agvet Code Act.

Power

The order which is sought for the applicant, being one relating to an entry on a register, raises the question whether the Court has power to make an interlocutory order interfering with a register. I am absolved from examining in detail the legal issues associated with that by a concession on behalf of the respondent that, on the authority of ss19 and 23 of the Federal Court of Australia Act 1976 (Cth), the Court could issue a mandatory order to delete a product from the register and consequently could make an interim order to that or similar effect.

Matters for consideration

The matters which fall to be considered in relation to the second paragraph of the notice of motion are those which arise in relation to interlocutory applications for injunctive relief generally.  They are, firstly, whether there is a serious question to be tried or whether the plaintiff has made out a prima facie case in the sense that, if the evidence remains as it is, there is a probability that at the trial of the action the plaintiff will be held entitled to relief.  Secondly, whether the applicant will suffer irreparable injury for which damages will not be an adequate compensation unless an injunction is granted.  Thirdly, whether that the balance of convenience favours the granting of an injunction: see Castlemaine Tooheys Ltd v South Australia (1986) 161 CLR 148. I turn to those three questions.

Whether serious question to be tried

Whether the evidence which the applicant brings will raise a serious legal issue to be tried is substantially affected by the context in which the relevant decision was made.  The
Agvet Code Act describes in s1, the objects of the Code. It is to make provision for and in relation to:

"(a)  The evaluation, approval, and control of the supply, of active constituents for proposed or existing agricultural chemical products or veterinary chemical products; and

(b)The evaluation, registration, and control of the manufacture and supply, of agricultural chemical products and veterinary chemical products."

By s3 an "agricultural chemical product" has the meaning given by s4. A "chemical product" means an agricultural chemical product or a veterinary chemical product: s3. A "veterinary chemical product" has the meaning given by s5. Section 4 provides inter alia, that an agricultural chemical product is a "substance or mixture of substances that is represented, imported, manufactured, supplied or used as a means of directly or indirectly ...destroying, stupefying, repelling, inhibiting the feeding of or preventing infestation by or attacks of any pest in relation to a plant, a place or a thing". "Active constituent" is defined by s3 to mean, "... the substance that is, or one of the substances that together are, primarily responsible for the biological or other effect identifying the product as an agricultural chemical product or a veterinary chemical product".

"Pest" is defined by s3 to mean, inter alia, "in relation to a place - an animal that injuriously affects the use or enjoyment of that place". The same section defines "substance" to include "an organism or part of an organism" and "material that is produced from an organism". It is arguable these definitions encompass the Rabbit Calicivirus Injection and the applicant does not contend to the contrary.

Section 12 of the Agvet Code provides the NRA is to publish a notice before determining an application for approval of any new active constituent.  It reads:

"12(1)  Before determining an application for approval of an active constituent not previously contained in a chemical product registered in this or another jurisdiction under the Agvet Code, or a corresponding previous law, of the jurisdiction concerned, the NRA must cause to be published in the Gazette, and in any other manner that it thinks appropriate, a notice:

(a)stating that the application has been made and setting out the following:

(i)the name of the constituent;

(ii)particulars of the constituent other than confidential commercial information;

(iii)a summary of the NRA's evaluation of the constituent with regard to the matters mentioned in par14(3)(e);

(iv)any other matters that the NRA thinks appropriate; and

(b)inviting any person who wishes to do so to make, within a period stated in the notice that ends not earlier than 28 days after the notice appears in the Gazette, a written submission to the NRA as to whether the application should be granted and stating the grounds on which the submission is based, which must be grounds that relate to matters that the NRA is required to take into account in deciding whether to grant the application.

(2)  The NRA must take into account any submissions made in accordance with an invitation contained in the notice published under subs(1)."

It will be noted the NRA is required by s12(2) to take into account any submissions made in accordance with an invitation contained in the notice published.

Applications for approval of an active constituent for a proposed or existing chemical product or for registration of a chemical product and thus for an agricultural chemical product or a veterinary chemical product are to be made to the NRA: s10. The NRA is required by s14 to grant the application: "If it is satisfied of all the matters referred to in subs(3)". If the NRA is not satisfied of all such matters it must refuse the application: s14(2).

The matters in relation to which the NRA must be satisfied are the following:  

"14(3)  The matters referred to in subs(1) are the following:

(a)that the applicant has complied with subs11(1);

(b)that any requirement made under ss157 and 159 has been complied with;

(c)that, if necessary, s158 has been complied with;

(d)that any requirements prescribed by the regulations in relation to the constituent, product or label as the case may be, have been complied with;

(e)if the application is for approval of an active constituent or registration of a chemical product - that the use of the constituent or product in accordance with the recommendations for its use that the NRA proposes to approve:

(i)would not be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and

(ii)would not be likely to have an effect that is harmful to human beings; and

(iii)would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; and

(iv)would not unduly prejudice trade or commerce between Australia and places outside Australia;

(f)if the application is for registration of a chemical product - that the use of the product in accordance with the recommendations for its use that the NRA proposed to approve would be effective according to criteria determined by the NRA for the product;

(g)if the application is for approval of a label for containers for a chemical product - that the label will contain adequate instructions relating to such of the following as are appropriate:

(i)the circumstances in which the product should be used;

(ii)how the product should be used;

(iii)the times when the product should be used;

(iv)the frequency of the use of the product;

(v)the withholding period after the use of the product;

(vi)the re‑entry period after the use of the product;

(vii)the disposal of the product when it is no longer required;

(viii)the disposal of containers of the product;

(ix)the safe handling of the product and first aid in the event of an accident caused by the handling of the product;

(x)any other matters prescribed by the regulations;

(h)that the fee (if any) prescribed in respect of the approval or registration, and any other amount (including an amount in respect of a tax or penalty) that is payable (whether by the applicant or by any other person) to the NRA in respect of the product under this Code or any other law in force in this or any other jurisdiction, have been paid."

It is to be noted that in s14(3)(e)(iii) the NRA must be satisfied where approval is sought for an active constituent that it would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment. Likewise under s14(3)(f) the NRA is required to be satisfied the use of the product would be in accordance with any recommendation for its use according to criteria determined by NRA for the product.

These provisions, which on their face require the NRA on being appropriately satisfied, to register the chemical product are matched by provisions elsewhere in the Act providing for suspension or cancellation of approval or registration: see Pt2 Div5 ss35‑46.

The evidence which the case for the applicant brings falls into three general areas.  The first is best exemplified by the evidence of a letter from a Professor to the NRA in which it is asserted a report ("the BCA Report") under the Biological Control Act entitled "Rabbit Calicivirus Disease" dated August 1996 prepared by the Bureau of Resource Sciences was in error in concluding the rabbit calicivirus would not infect any species other than the European rabbit.  The view of the Professor was that if the data before the Bureau of Resource Sciences had been properly understood, it would have been open to conclusion as a matter of interpretation of the relevant data that a large number of species, including humans, could be infected by the virus.  The Professor maintains the officials of the Bureau provided their own answers without regard for the scientific data.

Secondly, the next broad category of evidence in the applicant's case is that when the present representative of the applicant attended a "briefing" session conducted by the
NRA he heard an assurance given that the virus would only affect the one species namely, rabbit.  In his view, this representation tainted the decision‑making process to the point of invalidating it at law because it had the potential of discouraging some people from responding to the invitations for public consultation which the NRA was required to make.  In his submission, therefore, the issues were not properly understood because the brief was faulty.

The third broad category of evidence on which the applicant's case is based is that there is a link between the public consultation conducted by the NRA under the Agvet Code and public consultation under the Biological Control Act.  That is supported by reference to the affidavit of Trevor George Doust, Manager ‑ Veterinary Registration of the NRA.  That affidavit refers to a notice published by the NRA in the Commonwealth of Australia Gazette, Agricultural and Veterinary Chemicals Issues of 6 February 1996 (No NRA2) said to have been published in accordance with ss12 and 13 of the Agvet Code.  In that notice, it is stated:

"Please note that any relevant submission which has already been provided in writing to the Biological Control Authority in response to the advertisements published in national papers on 25 November 1995 will be taken into account by the NRA before a determination is made.  Further copies of these submissions need not be supplied to the NRA."

In my opinion, that notice is properly to be understood as not discouraging any further applications from persons who had already submitted applications to the Biological Control Authority, but as simply not requiring them to file a further copy of the same submission.

The affidavit of Mr Doust also provides evidence that all of the submissions received by the Biological Control Authority, and those provided directly to the NRA in response to its notice of 6 February, were taken into account by the NRA in its evaluation.  Further, included in those submissions was a submission by the Professor previously referred to (with another).  In addition, there is evidence the NRA's evaluation took into account the report of the Bureau of Resource Sciences and added independent evaluation of the
injection product's efficacy and its implications for human health, occupational health and safety, the environment and trade.

Mr Doust also deposes he has received directly from the applicant copies of the evidence now relied upon in this application and has had it examined. He has reached the conclusion it does not warrant the NRA reconsidering approval or registration as it is entitled to do pursuant to s31 of the Agvet Code. He further expresses the opinion that the evidence is not sufficient to entitle the NRA to suspend or cancel the registration of Rabbit Calicivirus Injection as it is entitled to do pursuant to s41(1) of the Agvet Code.

Mr Doust's affidavit is supported by an affidavit of Ms Ashton, a product evaluator in the Veterinary Registration Section of the NRA, who, having examined the additional information forwarded by the applicant and having reviewed it, concludes it does not raise any significant new material or issue and is no more than a restatement of submissions previously put before the NRA or the Biological Control Authority which were taken into account in making her evaluation report in the application for registration of the Rabbit Calicivirus Injection.

It is to be noted that, in the evidence which the applicant brings to this Court, there is no evidence the NRA has failed to comply with the statutory requirements for public consultation.  Furthermore, there is no evidence the weight of the submissions before the NRA from all sources was such that the NRA could not properly, and in accordance with the law, grant registration or now not either reconsider, suspend or cancel that registration.

It was submitted for the respondent the effect of the evidence now brought and relied upon by the applicant discloses the applicant's case is really against the merits of the findings of fact.  It is said by the respondent the applicant is contending that, in a context of conflicting views and scientific data, the view it prefers should have been favoured by the NRA.  I accept these submissions.  In my opinion the case which the applicant seeks to bring is directed to the merits of the matter before the NRA.

Furthermore, I accept the submission made for the respondent that the consultation process was not tainted, even if it was the case that at some particular meeting a representative of the applicant was given advice contrary to some of the submissions.  It is apparent from the evidence of Mr Doust and Ms Ashton that all submissions were evaluated and it is apparent from the evidence of Mr Doust there were no limits set to the right of the public to make submissions.

To set aside the relevant decision of the NRA or even the later decisions appearing in the affidavit of Mr Doust, it is necessary for some ground at law to be shown for that course of action to be taken. Having regard to s5(1) of the Administrative Decisions (Judicial) Review Act 1977 (Cth) ("the ADJR Act"), this is not a case where it is said that the rules of natural justice have been breached in a legal sense, or there was any lack of jurisdiction, or that the decision was not authorised by the enactment, or that procedures required by law were not observed.  No error of law has been identified.  It is not said that the decision was fraudulently induced.  There is no proper evidence brought to support allegations for the applicant that the decision to register was the result of conspiracy, lack of objectivity or recklessness.

This is not a case where there was no evidence or other material to justify the making of the decision, and no other ground of law has been shown.  The only argument on the applicant's case as brought, is that the decision was an improper exercise of the power conferred by the enactment because the exercise was so unreasonable that no reasonable person could have exercised the power in that way.  In my opinion that contention is simply not open on the evidence.  Whatever the arguments as to merits the applicant may wish to make, the case for the applicant does not bring evidence which would show against the evidence of Mr Doust and Ms Ashton, that this decision was not made after proper evaluation of all submissions publicly invited and before the NRA, and so was reasonably reached.

In my opinion there is not a serious issue to be tried at law in the case which the applicant seeks to bring out of its genuine concern at the release of the rabbit calicivirus through the registration of the injection.  In reaching that view, I do not need to rely on
any presumption that the acts of the NRA are legal.  Rather I rely on the evidence before me.  Nor do I need to consider the effects on third parties if a decision was taken in relation to the registration because that point is not reached. Cf R v HM Inspectorate of Pollution and Anor; Ex Parte Greenpeace Ltd [1994] 1 WLR 570.

Absence of evidence of damage

Those considerations are decisive against the applicant on this application but I add some further reasons in relation to the other two limbs of the matters I am required to consider.  This is not a case where there is any evidence from the applicant it will suffer irreparable injury for which damages will not be an adequate compensation.  That arises because, in effect, the applicant is acting as a public interest advocate which takes us back to the issues of standing. 

Balance of convenience

Turning to the third element, the balance of convenience, there were submissions as to whether any order made against the NRA in the terms sought by the applicant would be futile because of the provisions of the legislation relevant to the operation of the Agvet Code.  I refer particularly to the Agricultural and Veterinary Chemicals Act 1994 (Cth) and to complementary state legislation such as the Agricultural and Veterinary Chemicals Act 1995 (WA).  Following those submissions it was accepted for the respondent that the probability at least for the purposes of this interlocutory application, would be that any order in respect of the NRA would have effect against the entire range of relevant decisions under that legislation and its corresponding legislation in each of the jurisdictions.  As no order will be made, this issue does not pay any part in the resolution of the present application.

It is relevant also to the balance of convenience issue that s167(1)(b) of the Agvet Code Act provides:

"An application may be made to the Administrative Appeals Tribunal for review of the following decisions of the NRA:

(a)...

(b)  A decision under Div2 of Pt2 to approve an active constituent for a proposed or existing chemical product, to register a chemical product, or to approve a label for containers for a chemical product, subject to particular conditions."

The existence of this remedy as a matter falling for consideration if it were necessary to determine the balance of convenience, appears from s10(2)(b)(ii) of the ADJR Act.
Section 168 of the same Act provides:

"168.(1)  If written notice of the making of a decision to which s167 applies, or of the making of a decision under s166 which, because of subs166(5), is taken to be a decision to which s167 applies, is given to a person (other than a co-ordinator designated for this or another jurisdiction), that notice must include a statement to the effect that:

(a)subject to the Administrative Appeals Tribunal Act 1975, application may be made by or on behalf of a person whose interests are affected by the decision to the Administrative Appeals Tribunal for review of the decision to which the notice relates; and

(b)unless subs28(4) of that Act applies, application may be made in accordance with s28 of that Act by or on behalf of a person whose interests are affected by the decision for a statement in writing setting out the findings on material questions of fact, referring to the evidence or other material on which those findings were based and giving the reasons for the decision.

(2)  Any failure to comply with a requirement of subs(1) in relation to a decision does not affect the validity of the decision."

It appears from the evidence on this application that when the applicant was notified by the NRA of its decision by faxed letter dated 30 September 1996 there was no notification pursuant to s168. However, s168(2) provides failure to give the notice does not affect the validity of the decision of the NRA. In my opinion, such omission, even if the balance of convenience required weighing, would not mean the existence of the remedy should not weigh with the Court in determining whether it would be appropriate for the Court to intervene by way of injunctive relief.

For these reasons I conclude par2 of the motion of the applicant should be refused.

I certify that this and the preceding 12 pages are a true copy of the Reasons for Judgment of his Honour Justice R D Nicholson.

Associate:

Date:23 October 1996

APPEARANCES

Advocate for the Applicant:              Mr D Fuller

Counsel for the Respondent:             Mr P Macliver

Solicitors for the Respondent:           Australian Government Solicitor

Date of Hearing:            23 October 1996

Date of Judgment:         23 October 1996