What would breach regulation 4 of The Good Laboratory Practice Regulations 1999?

Doing the thing the provision prohibits under the Good Laboratory Practice Regulations 1999, whatever the reason for doing it. Where the requirement is a positive duty, letting the time for performing it pass without performing it.

Requirement to be a member or a prospective member of the United Kingdom good laboratory practice compliance…

Q: Is regulation 4 of The Good Laboratory Practice Regulations 1999 a strict liability offence?

The prosecution must prove that the conduct happened. This is a strict liability offence as drafted: the provision uses no word of intention, knowledge, recklessness or negligence, so there is no need to show that an operator meant to do it, knew about it, or was careless.

regulation 4 of The Good Laboratory Practice Regulations 1999

Status not determined
Strict liability
Health and safety, environment, waste and fisheries

This offence was read from the text as made, and no revised version was available, so a later revocation could not be ruled out. Check the current text at legislation.gov.uk.

What the provision says

4 A regulatory study shall not be conducted at any premises of a test facility unless— a the operator of the test facility is regarded by virtue of regulation 5 or 6 as a member or a prospective member of the United Kingdom good laboratory practice compliance programme (hereafter referred to as “the UK GLP compliance programme”); and b the operator’s membership or prospective membership of that programme is or is partly in respect of those premises, and if a regulatory study is conducted at any premises in contravention of this regulation, the operator of that test facility shall be guilty of an offence.

Text as made, from legislation.gov.uk. © Crown copyright, reused under the Open Government Licence v3.0. This is the text as originally made; later amendments are not shown here.

Who it binds, and what has to be proved

Binds: an operator
Conduct: contravening a requirement of the instrument
Fault element: Strict liability
Burden of proof: No statutory defence — prosecution proves everything

The prosecution must prove that the conduct happened. This is a strict liability offence as drafted: the provision uses no word of intention, knowledge, recklessness or negligence, so there is no need to show that an operator meant to do it, knew about it, or was careless.

Intention, knowledge and carelessness are irrelevant to guilt. They may still matter a great deal to sentence.

The provision states no defence, so the prosecution bears the burden on every element of the offence.

Classifier’s reasoning: no word of intention, knowledge, recklessness or negligence in the offence or its provision.

What would breach regulation 4?

These are illustrations, not law. They are generated from the provision’s own words to show the shape of the offence. Whether any particular conduct is caught depends on the full text, on any amendment since, and on the facts.

Doing the thing the provision prohibits under the Good Laboratory Practice Regulations 1999, whatever the reason for doing it.
Where the requirement is a positive duty, letting the time for performing it pass without performing it.

Penalty

Mode of trial: Not determined
Maximum fine: Not determined
Maximum prison (summary): Not determined

no penalty is stated in this instrument; it may be in the enabling Act, or in a general penalties provision this pass did not connect to the offence.

No penalty was determined from this instrument. It may be in the enabling Act, or in a general penalties provision this pass did not connect to the offence. Absence of a figure here is not evidence that the offence carries no penalty.

Sentencing

Offences of this kind are usually sentenced under the guidelines below. This is a mapping by subject, not a finding about this provision, and the links go to a search of the Sentencing Council’s own site.

Sentencing organisations: fines and the means of a corporate defendant All courts in England and Wales
How a fine on a company is arrived at from its turnover. Relevant far beyond the guidelines that state it, because a very large share of the offences in this corpus can only be committed by an organisation.
Environmental offences: definitive guideline Magistrates' courts and the Crown Court in England and Wales · in force from 1 July 2014
Covers unauthorised or harmful deposit, treatment or disposal of waste, illegal discharges to air, land and water, and the equivalent offences committed by organisations. It is the guideline that introduced turnover bands for corporate fines, so the size of the defendant company is a starting point rather than a mitigating detail.
Health and safety offences, corporate manslaughter and food safety and hygiene offences: definitive guideline Magistrates' courts and the Crown Court in England and Wales · in force from 1 February 2016
Covers breaches of duty under the Health and Safety at Work etc. Act 1974 and the regulations made under it, and food safety and food hygiene offences. Sentencing turns on culpability and on the seriousness and likelihood of harm risked, not only on the harm that happened.
Reduction in sentence for a guilty plea: definitive guideline All courts in England and Wales · in force from 1 June 2017
The sliding scale of credit for pleading guilty, from one third at the first stage of proceedings downwards.
General guideline: overarching principles All courts in England and Wales · in force from 1 October 2019
The guideline a court uses when there is no offence-specific guideline, which is the position for the overwhelming majority of offences created by statutory instrument. It sets out how culpability and harm are assessed from first principles.
Totality: definitive guideline All courts in England and Wales
How to sentence more than one offence at once so that the total is just and proportionate - frequently in point here, because regulatory prosecutions commonly charge several breaches of the same instrument.

Prosecution figures

No published per-offence figure was found for this provision, and it could not be matched to a Ministry of Justice offence code. Offences created by statutory instrument very largely do not have one. Absence of a figure is not evidence that the offence is unused.

Status and lifecycle

Current status: Status not determined
Made: 18 November 1999
In force from: 14 December 1999
Extent: Not stated

How this was established: read from the text as made; no revised version available, so later revocation could not be ruled out.

What the instrument is for

These Regulations contain the legislative measures necessary for the implementation within the United Kingdom of Council Directive 87/18/EEC on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances, as amended by Commission Directive 1999/11/EC adapting to technical progress the principles of good laboratory practice as specified in Council Directive 87/18/EEC, and for the implementation of Council Directive 88/320/EEC on the inspection and verification of Good Laboratory Practice (GLP), as amended by Commission Directive 1999/12/EC adapting to technical progress for a second time the Annex to Council Directive 88/320/EEC. Regulation 2 is an interpretation provision. Amongst other definitions, there is a definition of the principles of good laboratory practice, a concept which is defined with reference to the principles set out in Schedule 1 to the Regulations and the operating procedures set out in Schedule 2. Regulation 3 sets out the arrangements for enforcing compliance with the Regulations by the good laboratory practice monitoring authority (“GLPMA”). Regulation 4 contains a requirement that regulatory studies must only be conducted at test facilities which are part of the United Kingdom good laboratory practice compliance programme. Regulation 5 deals with prospective membership of the programme by test facility operators in respect of particular test facility premises, and Regulation 6 deals with full membership of the programme. Regulation 7 contains a requirement that regulatory studies shall be conducted in accordance with the principles of good laboratory practice. Where there are serious deviations from the principles, there is a procedure for serving warning notices on test facility operators requiring them to ensure that the serious deviation will not recur. Breach of such a notice is an offence, although there is an appeals procedure contained in Regulation 8, if an operator of a test facility is aggrieved by a decision to serve a warning notice on him. Regulation 9 contains the powers to enable persons duly appointed by the GLPMA to enforce compliance with the provisions of the Regulations, including powers of entry. Regulation 10 contains rules relating to the disclosure of commercially sensitive or other confidential information which may come to light as a result of enforcement action taken under the Regulations. Impeding the work of a person duly appointed by the GLPMA who is acting in pursuance of any of his functions under the Regulations is made an offence under Regulation 11. Regulation 12 contains offences relating to the production and supply to regulatory authorities of false good laboratory practice instruments. Regulation 13 relates to offences committed with the consent or connivance, or attributable to, bodies corporate or Scottish partnerships, and Regulation 14 is a general defence of due diligence in relation to any of the offences under the Regulations. Regulation 15 is a penalties provision, and Regulation 16 gives the GLPMA powers to charge fees for inspections and services under the Regulations. Regulation 17 revokes the Good Laboratory Practice Regulations 1997. A Regulatory Impact Assessment in relation to these Regulations has been prepared and copies may be obtained from the GLPMA, Room 1808, Market Towers, 1 Nine Elms Lane, London SW8 5NQ. A copy has also been placed in the library of each of the Houses of Parliament.

Read the full note and every offence in this instrument

Other offences in the same instrument

Disclosure of confidential informationregulation 10(1)
Obstruction etc. of authorised personsregulation 11(1)
False good laboratory practice instrumentsregulation 12(1)
False good laboratory practice instrumentsregulation 12(2)
False good laboratory practice instrumentsregulation 12(3)
Penaltiesregulation 15(c)

How this was identified as an offence

Everything above rests on the judgement that this provision creates a criminal offence, rather than mentioning one. That judgement is made by rule, from the words of the provision, and this is the rule that made it — with a confidence of 0.92.

Basis: the provision says a person is “guilty of an offence”
Confidence: 0.92 of 1.00

A provision that states a penalty for an offence created elsewhere can read very like one that creates an offence, and the rules can mistake the one for the other. If the text quoted above sets a penalty for something made an offence by another provision, treat the classification on this page with that in mind, and read the instrument.

Check the source

This provision on legislation.gov.uk The authoritative text. Check it before relying on anything here.
The Good Laboratory Practice Regulations 1999 Every offence this instrument creates, and its explanatory note
Health and safety, environment, waste and fisheriesOther offences on the same subject
Offences created in 1999