Freedom of Information Act 2000 – Request for Information Relating to the Use of Animals in Research by AFBI

To Whom It May Concern,

I write in accordance with the Freedom of Information Act 2000 (“The Act”) to request the disclosure of data held which concerns the use of animals in research by the Agri-Food & Biosciences Institute (“AFBI”). For the avoidance of doubt the term 'animal research' is defined as that governed by the Animal (Scientific Procedures) Act 1986 (“ASPA”).

The information I wish to request is as follows:

1) By species; how many animals were used and subsequently procured as part of research by AFBI in 2011?

2) By species; how many animals were bred for research purposes by AFBI in 2011? In the case of rodents, please list by genetic strain and specify for which patents are held.

3) Copies of any minutes from, or communications relating to, Ethical Review Committee (“ERC”) meetings, or boards of a similar nature for which your establishment uses a different title, for 2011.

I must stress that I am not interested in data which identifies those under the institution's employ and wholly agree for such personal information to be redacted.

As I am sure you are aware, The Act dictates that a response must be given within 20 days of receipt of this request. In the eventuality of any delay, I request that you keep me informed. If there are any matters on which you seek clarity, please do not hesitate to contact me.

Many thanks for your assistance and time spent in handling my request.

Kind Regards,

Luke Steele

FOI Officer,
AFBI Headquarters,
Newforge Lane,
Belfast, BT9 5PX

Monday 18th February 2013

Re: Ref AFBIFOI20130101

Dear Sirs,

Many thanks for your response to my request (“The Request”), dated 18th February 2013 and of the above reference.

I wish to take this opportunity to request an Internal Review regarding the refusal (“The Refusal”) to disclose documentation relating to Part 3) of The Request. The Refusal claimed exemption
under S.24(a) of Animal (Scientific Procedures) Act 1986 (“ASPA”) [1] and S.38(1)(b), citing the confidentiality of those involved in animal research and the safety of persons under the employ of AFBI.

S.24 ASPA – Introduction & Purpose Where Relevant to AFBI

S. 24 ASPA was introduced as part of ASPA in 1986, making it an offence for those under the employ of Designated Scientific Procedure Establishments (“DSPEs”) to disclose information which
was contributed in confidence as part of their role.

The reasoning for the introduction of S.24 was to prevent information from falling into what could be termed as 'the wrong hands'. This has a number of interpretations, however two are
particularly prominent in cases where exemption is sought:

1) Competition – Some organisations operate their businesses in a competitive nature and rely on confidentiality within their supplier and client network. It is argued that the disclosure of certain information may lead those business partners to seek contracts with other organisations of a similar business line, thus resulting in an unfair advantage for competitors. Such is the case with numerous DSPEs, such as Contract Research Organisations (“CROs”) and pharmaceutical developers.

However, this is not the case with AFBI which conducts research into matters relating to agriculture, food security and bioscience. As a government organisation AFBI does not have any competitors or financial interests to protect and thus cannot seek exemption under S.24(1) ASPA in this case.

2) Protection – Animal research enterprises are more concerned about the protection of employees than other organisations. This is largely as a result of perceived threat from the extreme fringe of the animal rights movement, but this does not present an exemption from disclosure. However, what this does mean is that organisations may redact information which may lead to the identification of staff.

In relevance to The Request, AFBI were invited to redact any information of this nature prior to disclosure. Additionally, documents which fall within the criteria of disclosure relate to the welfare of animals, statistics on animal use and not the identity of employees, sensitive buildings or other data of this nature. Consequently no exemption cannot be sought under S.24 (a) ASPA.

Summary of The Role of Ethical Review Committees

Premises conducting research on, or procedures involving, live animals are required by law to be licensed by the Home Office in accordance with ASPA. Such procedure is aimed at regulating animal welfare and ensuring that experimentation is only conducted within DSPEs, by those holding relevant project licenses.

However, responsibility is also placed on the individual DSPEs to conduct internal reviews of research through ERCs, or a similar board relevant to that institution. [2] The sole purpose of ERCs is
to peer review each research project on an individual basis and to establish if the proposed benefits to science or health outweigh any possible ethical implications. In the case of reviewing animal research, ERCs have the added onus to work within the Replacement, Refinement and Reduction (“3Rs”) policy. The latter framework seeks to establish three things - if there are methods available to avoid or replace the use of animals in the study (“Replacement”), if animal use can be minimised (“Reduction”), or if scientific procedure and husbandry techniques are available to minimise adverse effects on animal welfare (“Refinement”).

Membership of ERC panels usually consists of independent adjudicators within the establishment or department concerned, whose responsibility it is to uphold the 3Rs policy. It is also common procedure to invite representation from the facility's Named Veterinary Surgeon(s) (“NVS”) and Named Animal Care and Welfare Officer(s)(“NACWO”) to make points on any animal welfare implications associated with proposed or ongoing trials. The Personal License Holder (“PLH”) may also be invited to make comment when their proposed study is being discussed. Home Office Inspectors (“HOIs”) may also be present.

Statistics on the Use of Live Animals in Research

Premises conducting research on, or procedures involving, live animals are required by law to be licensed by the Home Office in accordance with ASPA. Such procedure is aimed at regulating animal welfare and ensuring that experimentation is only conducted within DSPEs, by those holding relevant project licenses.

On condition of research licenses being issued, Individual Project License Holders (IPLH) and DSPEs must complete Annual Statistical Returns documenting the number of animals used, their species and a vague description of the type of research undertaken. [3] These are returned to the Home Office Animals in Science Regulation Unit (“HOASRU”), allowing government monitoring of research trends and the identification of improvement under national 3Rs policy. Annually, the Home Office releases a compiliation of this data in the Statistics of Scientific Procedures on Living Animals – Great Britain report. [4]

The Confidentiality Test

The Confidentiality Test seeks to determine if S.24 Animal (Scientific Procedures) Act 1986 – Protection of Confidential Information - can be relied upon as a valid exemption to disclosure.

S. 24(a) ASPA 1986 states:

“A person is guilty of an offence if otherwise than for the purpose of discharging his functions under this Act he discloses any information which has been obtained by him in the exercise of those functions and which he knows or has reasonable grounds for believing to have been given in confidence”

Therefore, The Confidentiality Test must determine whether person(s) under the employ of the DSPE knew, or had reasonable grounds for believing, the information concerned was given in confidence. In this case, the information to which this test is being applied is that contained within the minutes of ERC meetings and statistics on animal use.

When submitting license applications to the Home Office Animals in Science Regulation Unit (HOASRU), details of the proposed research and matters discussed by the ERC must be given so as to show compliance with 3Rs policy. When given notice ERC minutes can be inspected by the HOASRU. It can therefore be deemed that it is likely that those present at ERC proceedings are aware the information is not given in confidence due to the possibility of data being divulged to an external body.

Further, many DSPEs publish the final findings of studies in respectable academic journals. These research papers are obtainable in the public domain and detail precise information regarding experiments undertaken, listing contact information of participating researchers and the establishment at which they were conducted. Such a process invites peer review, reference and facilitates the 3Rs process in ensuring that experiments are not repeated.

In the case of AFBI, numerous study papers have been published which fall within the scope of this request and were all discussed by ERCs:

1) A New Experimental Infection Model in Ferrets Based on Aerosolised Mycobacterium bovis – Veterinary Medicine International [5]

2) The effect of the method of dietry oil addition to pelleted diets on performance and nutrient digestibility in finishing pigs – Animal Feed Science & Technology [6]

3) Co-Infection of Cattle with Fasciola hepatica and Mycobacterium bovis – Immunological Consequences – Transboundary and Emerging Diseases [7]

4) Optimization of whole-blood gamma interferon assay for detection of Mycobacterium bovis-infected cattle – Clinical and Vaccine Immunology [8]

It must be considered that the cited study papers, which are limited to five randomly selected and published in the time scale of The Request, were authored by researchers with the consent of
AFBI. Inference can therefore be drawn that those contributing to the ERC process are aware that information is not given in confidence and details of experiments conducted by the DSPE can be published in the public domain following their conclusion.

Further, as cited in the previous section IPLHs and DSPEs submit Annual Statistical Returns to the Home Office each annum. These are inturn compiled and published in the public domain. Given that this is a mandatory obligation under condition of project licenses being issued, it can reasonably be argued that both an IPLH and DSPE are aware that the information is not being submitted in confidence.

Using The Confidentiality Test conclusive indication can be given that persons presenting information before the ERC are reasonably aware that this is not given in absolute confidence. As a consequence, disclosure is not exempt under S24(a) ASPA. Additionally, it can be deemed that persons submitting Annual Statistical Returns are aware that this is not given in absolute confidence.

The S.38 Exemption Test

The S.38 exemption test seeks to determine if S.38 (1) Freedom of Information Act 2000 – Health & Safety - (“The Act”) can be relied upon as a valid exemption to disclosure.

S. 38(1) provides that:

“Information is exempt information if its disclosure on this Act would, or would
be likely too:

(a) Endanger the physical or mental health of any individual, or
(b) Endanger the safety of any individual”

In this case, it can be deemed that the term 'endanger' can be interpreted in the same way as 'prejudice' in other exemptions in the Act. The Tribunal in the case of Hogan v Information Commissioner explained that the application of the prejudice test involved a number of steps:

“[F]irst there is a need to identify the applicable interest(s) within the relevant exemption...second, the nature of the 'prejudice' being claimed must be considered...a third step for the decision maker concerns the likelihood of occurrence of prejudice” [9]

The AFBI has applied section 38(1)(b) to the information in respect of all of the questions within the request. Section 38(1)(b) provides that information is exempt if disclosure would, or would be likely to, endanger the safety of any individual. The AFBI argues that this is the appropriate part of the exemption to apply because disclosure would, in its opinion, be likely to lead to the organisation being targeted by animal rights extremists, which would endanger the safety of the institution's staff and other individuals associated with the institution.

In the Hogan case the Tribunal commented that “an evidential burden rests with the decision-maker to e able to show that some casual relationship exists between the potential disclosure and the prejudice”.

What now must be considered is whether, in the circumstances of this case, a link can be made between disclosure of the particular information requested and the possibility of the threat posed by animal rights extremists would increase.

For this to be established, it must be taken into account that AFBI have admitted to holding the data concerned and thus in effect publicly confirmed their engagement in animal research. Irrespective of the number of animals used, the species on which licensed procedures were undertaken and the level of internal breeding taking place, the matter remains that it is now public knowledge that AFBI engage in animal testing. This, in the eyes of those from whom the authority seek protection, is a 'legitimate reason' in itself to target the organisation as any animal use is wrong, regardless of the scale on which animals are used. Consequently, any potential threat level will not be altered by disclosure.

Additionally, the data contained within annual returns and, with redaction, the minutes of Ethical Review Committee meetings would not identify those under the employ of AFBI, thus all risk would be removed.

Further, research carried out by AFBI's academics is routinely published in scientific journals. Whilst such information may not be intended for the public at large it is nevertheless publicly available. Indeed, it is possible to find a number of publications on the pubmed and Google Scholar websites which show the authority is involved in research involving animals. Given that such information also includes the names of academics involved, it is difficult to see what further prejudice would be caused by the disclosure of this more general information on the number of animals used in research carried out by the authority, the number of animals bred and the redacted content of Ethical Review Committee meetings.

It must now be considered the likelihood that disclosure of the information in the request and the redaction of personal data would endanger the safety of any individual if it were disclosed. It must be considered that the term 'endanger' should be interpreted in the same way as the term 'prejudice' in other exemptions in the Act. In this case, AFBI has indicated that the exemption is engaged because disclosure would be likely to endanger the safety of individuals. When discussing the prejudice test the Information Tribunal in John Connor Press Associates Limited v The Information Commissioner confirmed that “the chances of prejudice being suffered should be more than a hypothetical possibility; there must have been a real and significant risk”. [10] This in turn follows the judgement of Mr Justice Munby in R (on the application of Lord) v Secretary of State for the Home Office. In that case, the view was expressed that:

“Likely connotes a degree of probability that there is a very significant and weighty chance of prejudice to the identified public interests. The degree of risk must be such that there 'may very well' be prejudice to those interests, even if the risk falls short of being more probable than not.”

In light of this the view is taken that in order for the exemption to be engaged on a “would be likely to endanger” basis the risk of endangerment need not be more likely than not, but must be substantially more than remote. It must now be considered whether disclosure would be likely to endanger any individuals involved in animal research at the AFBI, including its staff.

As note above, the AFBI have been invited to redact all information regarding the identity of staff and anything additionally deemed to be of a sensitive nature. This, therefore, removes all potential for further prejudice.

In a similar case - Luke Steele v The Governing Body of Keele University [Ref: FS50303734; March 2011] – the ICO ruled in favour of limited disclosure of statistics relating to the number of animals used in research. It was deemed that no increase in threat to the public authority would occur as a result of disclosure of similar statistical data, as a consequence of it being public knowledge that the said institution conducts animal research. Additional indication was given that “Public authorities are not entitled to rely on general arguments concerning the public interest maintaining the exemption”.

The Public Interest Test

The Public Interest seeks to establish if information sought falls within the remit of public concern.

Information contained within ERC minutes sought through The Request concern this subject. As already stated, the primary role of the ERC committee is to implement the 3Rs and raise important questions surrounding this policy. It is certainly in the public interest to see that such a process is being undertaken to the highest standards possible and invite constrictive critique in order to facilitate improvement, should it be needed.

In addition, as part of the DEFRA, CEFAS is operated on government funding and consequently all animal studies are paid for through tax-payers monies. It is therefore of high interest to show that animal welfare is stringently being upheld within public institutions where experimentation is taking place.

Consideration must also be taken as to how others within the research sector respond to requests for data under Freedom of Information legislation. It can be determined that S.24(a) was not deemed relevant to numerous high-profile public institutions when faced with similar requests, with full disclosure of ERC minutes was provided subject to redaction. [11] [12] [13]

Consequently, it is a fair statement to make that the disclosure of ERC minutes meets the requirements of The Public Interest Test.

Conclusion

The above evidence clearly shows S.24(a) Animal (Scientific Procedures) Act 1986 does not provide a valid exemption from disclosure in this case.

Firstly, AFBI does not fall within the scope of protection for which S.24 was introduced – not only does the facility not have competing organisations, and therefore cannot hold information sensitive in relation to remaining competitive as part of an industry, but also that the disclosure of information sought will not fuel any adverse consequences where employees are
concerned.

In addition, The Confidentiality Test leans towards disclosure. Employees cannot have reasonably thought information was, or was likely to have been, given in confidence when detailed study papers are published in the public domain following study conclusion. Secondly, the content of ERC minutes are available for inspection by external bodies, such as the Home Office Animals in Science Regulation Unit, upon application for experimental licenses.

The S.38 Exemption Test indicates, through historical evidence obtained from previous rulings, that no additional threat or prejudice is incurred as a consequence of disclosure.

The Public Interest Test also leans towards disclosure. It is imperative that government funded organisations, particularly those who conduct licensed procedures, are open in their conduct. This allows external constructive critique to ensure policies such as the 3Rs are met and that the highest standards of animal welfare are upheld. It must also be taken into consideration that other public institutions have published their retrospective ERC minutes.

Further, it is common knowledge that data included in Annual Statistical Returns is compiled and published annually. It cannot reasonably be said that persons involved in this process were unaware of this and thus disclosure would not conflict with S.24(a) ASPA.

In conclusion, I request that the above matters are taken into consideration and an Internal Review is conducted regarding disclosure.

I await your response.

Yours Sincerely,

Luke Steele

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Sources:

[1] Section 24 – Animal (Scientific Procedures) Act 1986 :- http://www.legislation.gov.uk/ukpga/1986...

[2] University of Oxford – Committee on Animal Care and Ethical Review :- http://www.admin.ox.ac.uk/statutes/regul...

[3] User Guide to Home Office Statistics of Scientific Procedures on Living Animals (Home Office; July 2012) - http://www.homeoffice.gov.uk/publication...

[4] Statistics of Scientific Procedures on Living Animals – Great Britain (Home Office; July 2012) :- http://www.homeoffice.gov.uk/publication...

[5] Veterinary Medicine International (2011; Vol. 2011, Article ID 981410) :- http://www.hindawi.com/journals/vmi/2011...

[6] Animal Feed Science & Technology (March 2010; Vol. 156, Issue 3, Pages 89 - 96) :- http://www.animalfeedscience.com/article...

[7] Transboundary and Emerging Diseases (July 2009; Vol. 56, Issue 6-7, Pages 269 - 274) :-
http://onlinelibrary.wiley.com/doi/10.11...

[8] Clinical and Vaccine Immunology (August 2009; Vol. 16, No 8) :- http://cvi.asm.org/content/16/8/1196.short

[9] Hogan v Information Comissioner and Oxford City Council [EA/2005/26] and [EA/2005/30], paras. 28 - 34

[10] John Connor Press Associates Limited v The Information Commissioner [EA/2005/005], para. 15.

[11] University of York – Vivisection statistics and committee meetings (July 2009) :-
http://www.whatdotheyknow.com/request/vi...

[12] University of Newcastle – Vivisection statistics and committee meetings (July 2009) :-
http://www.whatdotheyknow.com/request/vi...

[13] University of Leeds – Vivisection statistics and committee meetings (June 2009) :-
http://www.whatdotheyknow.com/request/vi...