Memorandum from the Department of Environment,
Food and Rural Affairs
REGULATIONS 2002 (S.I. 2002/2443)
1. The Joint Committee has requested the Department
to submit a memorandum concerning the above regulations on the
(I) Regulation 21(2) provides that the Secretary
of State must not grant or refuse consent to release genetically
modified organisms before the end of the period of 60 days
beginning with the day on which the application for consent was
received. Explain the inclusion of the underlined words, given
regulation 20(b) and (f). Should not the provision have been to
the effect that the Secretary of State must not grant or refuse
consent before the end of the latest date on which the representations
and comments mentioned in regulation 20(f) can be made?
2. Regulation 21(2) is intended to assist the reader
by specifying the minimum period of days which must elapse before
the Secretary of State can make her decision following receipt
of an application for consent. This period is calculated by reference
to the time limit for submission of representations set out in
regulation 20(b) and by reference to the requirement on the Secretary
of State under regulation 20(f) to take into account those representations
and any comments made by member States.
3. The Department acknowledges that the approach
set out by the Joint Committee would achieve the same intention.
(2) Explain why no provision is made in regulation
21(4)(b) for excluding any period of time during which the Secretary
of State is considering comments made by the competent authorities
of other Member States (see regulation 20(f)).
4. Regulation 21(4)(b) transposes article 6(6)(a)
and (b) of Directive 2001/18/EC. The Directive makes no equivalent
provision in relation to the comments made by the competent authorities
of other member States.
(3) In a case where the Secretary of State refuses
an application for consent to market genetically modified organisms,
regulation 23(2) requires her to forward certain material to the
Commission no sooner than 15 days from the date
she sent the assessment report to the applicant and no later than
105 days from the date she received the application. Explain the
reason for the restriction indicated by the underlined words.
5. The restriction to which the Joint Committee refers
in regulation 23(2) transposes the last paragraph of article 14(2)
of the Directive.
(4) Explain why, in relation to an application
for renewal of consent to market genetically modified organisms,
paragraph (1)(c) and (d) of regulation 25 does not specify a period
of time within which the steps mentioned in that paragraph must
be taken by the Secretary of State: compare regulation 23(1)(d)
and (e) which imposes a time limit in relation to similar steps
to be taken by the Secretary of State on an application for consent
to market genetically modified organisms.
6. Regulation 23(1)(d) and (e) transposes the time
limits laid down in article 14(2) of the Directive (as read with
the last paragraph of article 13(1)) for sending the applicant
an assessment report and forwarding a copy of the application
to the Commission. The procedure governing applications for renewal
of consent are set out in article 17 of the Directive, which is
expressly stated to derogate from articles 13 and 14. Article
17 does not impose specific time limits.
(5) In relation to regulation 30, indicate whether
section 119 of the Act has been previously amended. If so, identify
the amending instrument, and explain why this information was
not provided in a footnote. If section 119 has not been previously
amended, furnish the text of that provision as amended by regulation
7. Section 119 of the Act has not been previously
amended. The text of the provision as amended by regulation 30
reads as follows (with text inserted by regulation 30 underlined)
"119. - (1) In any proceedings
for either of the following offences, that is to say-
(a) an offence under section 118(1)(c) above
consisting in a failure to comply with the general condition implied
by section 112(4)(c) or (5)(c) above; or
(b) an offence under section 118(1)(d) above
consisting in a failure to comply with section 109(3)(c) or (4)(c)
it shall be for the accused to prove the matters
described in subsection 1A below.
(2) Where an entry is required by a condition in
a consent to be made in any record as to the observance of any
other condition and the entry has not been made, that fact shall
be admissible as evidence that that other condition has not been
(6) Explain whether section 119(1) of the Act
(as amended by regulation 30), which requires the accused to prove
certain matters, is intended to impose a legal or an evidential
burden of proof on the accused. If a legal burden is intended,
explain the basis of the conclusion that this would be compatible
with Convention rights. If an evidential burden is intended, explain
why this is not made clear.
8. Section 119(1) of the Act (as amended) is intended
to impose a legal burden of proof. This form of words has been
used in post- Kebilene
legislation to impose a legal burden.Where Parliament intends
to create only an evidential burden the legislation makes this
clear; see Lord Hope's discussion of the Terrorism Act 2000 at
paragraph 92 and 93 of R v Lambert  3 WLR 206.
9. In concluding that the regulations are compatible
with Convention rights the Department has had regard to ECHR jurisprudence
which establishes the compatibility of reverse burdens of proof
with Convention rights (see, for example, Salabiaku v France
 13 EHRR 379).
10. In Lambert their Lordships "read
down" the legal burden of proof on the defendant to an evidential
burden to make it compatible with Convention rights; but this
was, strictly, obiter in view of their ruling that the Human Rights
Act 1998 should not apply retrospectively. More recent indications
are that the courts are willing to distinguish Lambert.
For example, in Lynch v DPP  EWHC Admin 882, 
2 All ER 854 it was ruled that placing a legal burden of proof
on the defendant was not unfair; and Lynch was refused leave to
appeal by the House of Lords Appeal Committee.
11. Although there have been no cases since the Human
Rights Act 1998 involving regulatory offences, a landmark decision
of the Canadian Supreme Court is helpful. In The Wholesale
Travel Group  3 SCR 154 the Supreme Court ruled that
it is not incompatible with Charter rights to impose a legal burden
on the defendant in regulatory spheres where a "due diligence"
style of defence is provided for because to reduce the onus on
the accused would create "insurmountable barriers for the
Crown" seeking to enforce a regulatory scheme; because, if
the regulatory authority had to anticipate and disprove such matters,
regulatory investigations would be more complex and necessarily
more intrusive; and because it is especially fair to impose a
legal burden on those who participate in regulated activities
because they have chosen to do so and have placed themselves in
a responsible position with regard to the public.
1 R v DPP ex parte Kebilene  3 WLR 972 (HL)(E) Back