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FSA REPONSE TO THE ENFORCEMENT OF SMALL FOOD MANUFACTURERS
REVIEW
Summary
1. In response to the review a number of significant activities will be undertaken.
These include working with industry on guidance on food hygiene, providing
significant further training for enforcement officers, including an innovative elearning package that will also be useful for business, and working with local
government on the options for greater partnership working between
enforcement authorities to improve consistency, the sharing of expertise and
ways to strengthen redress. A summary of the actions to be taken forward in
England can be found at Annex A.
Background
2. The review looked at regulatory activity in England by national regulators and
local authorities that affects/is perceived to affect the day-to-day running of
micro- and small businesses (employing fewer than 50 employees) involved in
food and drink manufacturing.
3. The review identified where all parties involved with the enforcement of food
legislation in small businesses can make improvements. The review indicated
that overall the enforcement system is working, that there are many instances
of good work by enforcement officers, backed up by useful guidance, and
support from the FSA as the Central Competent Authority, but improvements
can be made and there is no room for complacency.
Consideration
Helping business with HACCP
4. The key finding of the review was that businesses noted the HACCP system
of food safety management can appear burdensome and bureaucratic and the
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manner in which it should be implemented is not always clear. In response to
the report findings the FSA will look again at the existing material that has
been provided for small food manufacturing businesses and consider how it
can help businesses comply with HACCP requirements in ways that minimise
the associated administrative burden. The FSA will draw on its success with
the development and implementation of its Safer Food Better Business
material, which helps small catering businesses comply with HACCP
requirements, to help manufacturers.
5. The FSA will be working with industry stakeholders across the UK to identify
HACCP guidance, industry guides and EU guides currently in use with the
aim of making this information available more widely and to identify gaps in
the material. It will also look at ways to explain where exemptions to HACCP
apply (for example for simple processes like slicing sandwiches). As part of
this review the FSA have asked Campden BSI to interview a cross section of
small food manufacturers (~100 FBOs) to determine whether they find
HACCP guidance accessible or useful, and whether they find current
legislation over-burdensome.
6. From the results of this review the FSA will determine the best way to proceed
in helping small food manufacturers comply with the requirements of
implementing a food safety management system based on the principles of
HACCP. The FSA aim is to assemble this material by the end of 2012 and
then planning will begin to ensure full implementation of outcomes by June
2013. For example, if we find that manufacturers require more general
simplified guidance on HACCP then we will ensure completion and publication
of this guidance by June 2013.
7. The FSA will also be working with local authorities (LAs), to explain where to
source further information and advice about HACCP requirements, in
particular in relation to information about HACCP for different specialist
industry sectors.
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8. The action plan will be reviewed through stakeholder forums including the
Better Regulation Advisory Group and the FSA Industry Stakeholder Forum
and seek feedback utilising the FSA e-news facility.
E.coli O157and cross-contamination guidance
9. The review also questioned whether the requirement in the FSA’s cross
contamination guidance for separate sets of complex equipment e.g. vacuum
packers, slicers for processing raw and ready to eat foods was proportionate
in every case, or consistent with the requirement in EU law for every business
to develop and implement their own food safety management systems based
on HACCP principles. There is a legal requirement on food businesses to
manage food safety using HACCP principles, by ensuring that hazards are
identified and that critical controls are established, implemented and verified.
The FSA’s guidance ‘E.coli O157 Control of Cross-Contamination’ clarifies the
circumstances in which E.coli O157 cross-contamination hazards should be
considered; the control measures required to effect adequate control and that
a lapse in these controls represents an imminent risk to public health. With
the exception of dual use of complex equipment businesses may put in place
alternative methods of control other than those stated in the guidance,
provided they are supported by robust verification. In the absence of
verification the guidance provides an evidenced approach to the control of
cross contamination and supports businesses in implementing the HACCP
requirement.
10. The FSA however considers that the dual use of complex equipment should
never be considered safe. The guidance was developed in response to the
findings of a Public Inquiry into the 2005 outbreak of E.coli O157 in South
Wales and the recommendations from Professor Hugh Pennington. It is based
on the need for food businesses to control the risk of cross-contamination
between raw and ready-to-eat foods. This reflects the serious impact that
cross-contamination can have on public health, as witnessed by the multiple
outbreaks in the UK of E.coli O157, where contamination of ready-to-eat
foods has resulted in a number of people becoming seriously ill and, in some
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cases, dying. E.coli O157 is of particular concern due to its relatively high
incidence in the UK, the fact that only a few organisms are required to cause
a potentially fatal infection and the lack of effective treatment for people
infected, which can lead to permanent kidney or brain damage. The guidance
is also intended to tackle the risk of cross-contamination from other food
borne pathogens. In the UK in 2009 it is estimated that there were around 1
million cases of food poisoning, leading to around 23,000 hospitalisations and
about 500 deaths, at an estimated cost of £1.7 billion to the UK economy.
11. Professor Pennington stated in his Inquiry report that ‘The difficulties of
making complex equipment microbiologically safe, bearing in mind the very
low infective dose of E.coli O157, and the need for a business to be able to
demonstrate that such safety can be, and is, delivered routinely, are important
issues. For a vac packer, I do not think that such a demonstration is possible
to allow its use for ready to eat foods and raw meat.’ In addition to the finding
of the Public Inquiry, the FSA’s view on no dual use of complex equipment is
based on a number of scientific studies. These show that it is not possible to
manage procedural controls such as cleaning and disinfection and
handwashing, to ensure they are carried out adequately on all of the required
occasions to effectively control the risk of cross-contamination, particularly
when busy. A Hygiene Monitoring Initiative undertaken during the summer of
2012, provided further evidence to support this view. Surfaces which
business had cleaned and looked visibly clean, contained unacceptable levels
of contamination including slicers where 77% failed. The use of separate
equipment for raw and ready-to-eat is therefore regarded as the only safe
method with regards complex equipment.
12. A paper on the evaluation of the guidance was considered and endorsed by
the FSA Board at their November 2012 meeting1. The key part of the
evaluation was independent research with 150 LAs and 2051 businesses to
canvass their views. Most LAs and businesses found the guidance easy to
understand. Difficulties in understanding related to its length, the language
. The paper for the Board meeting and full research can be viewed at
http://www.food.gov.uk/business-industry/guidancenotes/hygguid/ecoliguide.
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used or its practical implementation. A third of businesses had made changes
as a result of the guidance, with the most common changes being the use of
designated separate areas for ready-to-eat foods and separation in storage
and display. Fewer than 20% of butchers found the introduction of separate
complex equipment challenging and fewer than 10% of businesses cited any
other changes as notably challenging. A third of businesses incurred costs
when making changes, with an estimated average cost of £802. Almost all
the businesses reported that there had been benefits associated with the
change including less health risk and better staff understanding.
The paper identified opportunities to raise awareness and understanding of
the guidance, including working with industry stakeholder groups and a review
will now be taken forward, whilst retaining the underlying principles. This will
build on engagement with stakeholders that has taken place since the
publication of the guidance. In particular we will review how we might
incorporate some practical issues that have been raised by business. The
FSA remains committed to ensuring the guidance is effective and making it as
user friendly as possible. The FSA would encourage businesses and
enforcement officers to raise any queries about the guidance through its
dedicated mailbox Controllingecoli@foodstandards.gsi.gov.uk.
We have heard the concerns about the requirement relating to separate
machinery, and in order to ensure that we address those concerns we
propose to engage one of the leading food science laboratories and research
centres in the UK to independently test the alternative controls to crosscontamination proposed by stakeholders. We will test a range of scenarios
including those suggested by stakeholders to identify if there are any
practicable steps that mitigate the risk of cross-contamination to an
acceptable level.
Support for enforcement officers and quality of inspections
13. The review identified a few cases where enforcement officers have been
found at times to lack specialist knowledge. The FSA understands the
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difficulties faced by enforcement officers with the wide-ranging nature of the
businesses they work with, for this reason the FSA provides specialist training
(e.g. on specialist cheese making). The review findings have however
usefully flagged where further opportunities arise and the FSA is keen to
approach these areas with training to fill knowledge gaps. The FSA also has
begun to explore potential for LAs to work closer together to not only improve
competency of enforcement officers and therefore improve food safety but
also reduce burdens where appropriate and improve support to business.
Ease of understanding of regulatory requirements; labelling enforcement
across LA boundaries
14. The review raised concerns from small businesses regarding compliance with
the new Provision of Food Information to Consumers European regulation
((EU) 1169/2011). Defra is leading work in close consultation with FSA and
DH, is drafting ‘guidance for compliance’ as part of the introduction of a
Statutory Instrument (SI) implementing the new EU Regulation of the
Provision of Food Information to Consumers (FIC) due to come into force in
April 2013. The ‘guide to compliance’ will be for a broad audience (both for
food businesses and enforcers) and is mostly non-technical. It is to be
produced as part of the package for public consultation on the SI and mostly
relates to the aspects of the Regulation requiring enforcement.
15. Further technical guidance is being developed with industry. Production of the
guidance will be led by DEFRA working with DH and FSA. The needs of
enforcers in relation to this guidance will be considered with LAs across the
UK. This work has been initiated and will be continuing from October 2012 to
March 2013.
16. The plan for communicating the new requirements to stakeholders are twofold, the FSA is commissioning Campden BRI to carry out 4 FIR training
sessions for LA enforcement officers in 2012/13, between Oct and March.
More training is planned for enforcement officers in 2013/14. FSA and
DEFRA are also planning to develop an e-learning package within the next 12
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months on the FIR which will be aimed at food law enforcement but will also
be available to food businesses and consumers.
Frequency of inspection and earned recognition
17. Delivering risk based enforcement is a theme that is often raised by
businesses and was noted in the review findings.
18. The FSA does not regulate on the size of the business, but on the risk
associated with its operations. The level of risk, with respect to food safety, is
not determined by the size of the business. A food safety failure at a small
business supplying major multinational businesses and national retailers has
the potential to affect a large proportion of the population. Small caterers and
small businesses have been linked to outbreaks of foodborne illness.
19. The current FSA Strategy (2010-2015) puts effective, consistent, risk-based
and proportionate enforcement at its heart. To that end, for example, the FSA
is committed to further developing earned recognition to ensure that
businesses are rewarded for compliance with fewer inspections. The next
Code of Practice revision (March 2013) will include changes to the inspection
frequency system to significantly reduce burdens on compliant premises. In
addition, in response to the findings, the FSA will make a concerted approach
to industry to produce sector specific industry guides that help compliance
with food law.
Appeal mechanisms
20. In line with the Government’s objective to ensure that sanctions are
proportionate to the offence committed, Defra will be making use of civil as
opposed to criminal sanctions for what are generally accepted as minor
offences e.g. breaches in food labelling legislation. This approach fits well with
the current FSA Strategy which puts risk-based and proportionate
enforcement at its heart. The use of civil sanctions will apply to Regulations
such as the FIR referred to earlier. The enforcement regime will consist of an
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improvement notice requiring the person to comply with the Regulations. This
change will require the introduction of an appeals mechanism to provide a
means of recourse if someone believes they have been issued with an
improvement notice when they had complied with the regulation.
21. The procedure for lodging an appeal will require the following action. In the
first instance representations can be made by the food business against the
provisional improvement notice. Appeals are then made to the First-tier
Tribunal. Tribunals are specialist judicial bodies which decide disputes in a
particular area of law. Most tribunal jurisdictions are part of a structure created
by the Courts and Enforcement Act 2007. The First–tier Tribunal has a wide
range of subject-matter, and will hear appeals against improvement notices.
In any improvement notice there will be information in the notice that will direct
the recipient to the relevant area on the First-tier Tribunal website highlighting
the mechanism for appeal against the First Tier Tribunal. Appeals will be
made to the General Regulatory Chamber. The tribunal is empowered to deal
with a wide range of issues which might form the substance of appeals, and to
ensure cases are dealt with in the interest of justice and minimising parties’
costs.
22. More generally, regarding resolving disagreements between enforcement
officers and businesses, for example where the business may feel that the
intervention of the EHO or TSO is disproportionate or goes beyond the
requirements of the law, the FSA is keen to work with local government on
ways to strengthen relations between Councils and increase the options for
businesses to seek a ‘second opinion’ on enforcement advice. This area of
work is in the early stages but we expect to develop options by the end of
2012, with implementation timetables dependent on local authority
prioritisation.
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Annex A
Review Findings
Helping
business
HACCP
Actions
with The FSA will assemble a summary report by
December 2012, by working with industry
Timetable
Summary report on helping manufacturers
comply with HACCP by December 2012.
stakeholders, outlining what guidance is currently
available, whether this is accessible and used by
Implementation of action plan by June 2013.
industry, and what the FSA can do to further help
small manufacturers. Preliminary findings from
Monitoring of actions by BRDO Business
work carried out on behalf of the FSA by
Reference Panel Summer 2013.
Campden BRI in this area show that industry has
problems finding the appropriate guidance. One
outcome therefore could be improving
communication channels to businesses.
The FSA will complete implementation of the
action plan by June 2013. To monitor
effectiveness, FSA will consult its own industry
stakeholders and will work with the Better
Regulation Delivery Office’s Business Reference
Panel.
E.coli and cross
Formal evaluation of the guidance has been
Establishment of stakeholder drafting group
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contamination guidance
conducted and following agreement by the FSA
Spring 2013.
Board at their November 2012 meeting, the
guidance and supporting materials will continue
E.coli O157 bespoke LA officer training
to be reviewed and informed by the
programme. 1500 places available across 50
establishment of a stakeholder drafting group,
courses for this year and more to be rolled out
which will include trade associations.
next financial year across the UK.
Rollout of training to local authority officers will
continue. This routinely provides feedback that
Comprehensive review of Food Hygiene Delivery
informs changes to the training programme.
Programme in 2014.
There will be a comprehensive review of FSA’s
Food Hygiene Delivery Programme in 2014.
This will include a further review of the cross
compliance guidance.
Support for enforcement
FSA will continue to work with Councils to
Support provided through the Quarterly Food
officers and improving
improve competencies and consistency through
Hygiene Focus Group and Monthly LA regional
quality of inspections
its audits and the work of its regional team, as
Food Liaison Groups.
well as utilising the quarterly Local Authority
Food Hygiene Focus Group to disseminate
Feedback from the above coupled with FSA
innovative and better practices. It will also
audits to monitor improvements and inform
strengthen collaborative partnerships with local
ongoing training programme.
authority representative bodies and the
Businesses requirements to be considered
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professional bodies (such as CIEH and Local
through ongoing work with BRDO including
Government Association).
utilising the Business Reference Panel on an
Through these and other mechanisms, FSA will
ongoing basis.
continue to identify knowledge and skills gaps
and provide training and guidance where
required. Businesses will continue to be
consulted through the BRDO Business
Reference Panel.
Local Authority officer training 2013-2014 to
include auditing of food safety management,
HACCP assessment, and investigative skills and
sector specific training, such as specialist cheese
making, on-farm pasteurisation and cannery
inspection.
Ease of understanding of
Defra is leading on drafting ‘guidance for
FIC guidance on compliance to be issued in
regulatory requirements
compliance’ for the FIC. Ways of communicating
November 2012.
the new requirements to stakeholders are twofold, training sessions for local authority
Enforcement officers training requirements for the
enforcement officers and development of an e-
FIC to be monitored during consultation from
learning package for all stakeholders. Progress
January 2013 to implementation of SI in April
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on informing enforcement officers about the FIC,
2013.
and checking their training needs, will be
monitored during the consultation period in
Enforcement officer’s E-learning training
January and prior to the implementation of the
development work to begin April 2013.
new SI (expected in April 2013). Training and
support will continue into 2013-14 and reviewed
Training and support will continue into 2013-14
again as the new rules come into force (first date
and reviewed again as the new rules come into
1 January 2014.).
force (first date 1 January 2014.)
Business views will be sought through Business
Ongoing feedback from business through the
Expert (Labelling) Group facilitated by BRDO.
Business Expert (Labelling) Group facilitated by
This will help monitor progress.
BRDO, next meeting due in December.
Frequency of inspection and
The FSA is committed to further developing
Code of Practice revision March 2013 (to be
earned recognition
earned recognition to ensure that businesses are
agreed by Ministers).
rewarded for compliance with fewer inspections
where appropriate. The FSA will submit revisions
of its Code of Practice for Ministerial approval
(March 2013), which will reduce inspection
frequency of broadly-compliant businesses in the
largest rating category.
Lack of an appeals
For the FIR, an appeals mechanism will be
Alternative appeals mechanisms to be considered
mechanism for businesses
introduced to provide a means of recourse if
by end December 2012 for review by the BRDO
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someone believes they have been issued with an Business Reference Panel early 2013.
improvement notice in error.
Subsequent actions monitored through Business
FSA will examine current arrangements for how
Reference Panel and LA business satisfaction
businesses challenge regulators, and develop
surveys.
alternative models by end of December 2012.
This will include looking at whether local
authorities could work in partnership to offer
shared opinions. It will explore these models
directly with businesses, by utilising, for example,
BRDO’s Business Reference Panel as well as
with local authorities. It will subsequently monitor
business challenge outcomes and impacts with
this panel, as well as through local authority
business satisfaction surveys and FSA regional
staff.
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