Biogas plants & Animal By-Product (ABP) Regulations

Melanie Farrar MVBVeterinary Inspector

TSE and ABP DivisionDepartment of Agriculture, Fisheries and Food HQ

What We Will Cover Today

(1) Context and Background

(2) Regulatory requirements in biogas plants

(3) Application and approval process

(1) Context and Background

The Agri-Food Industry in Ireland

• Agri-food industry very important to the Irish economy• Largest indigenous industry• 10% employment• 6.6 million cattle• Export 9 out of every 10 beef animals• In 2010 - €7.9 billion agri-food exports• 25% net foreign earnings• Largest net beef exporter in Europe and one of the

largest worldwide (€1.6bn)• World’s largest producer of infant formula• Outperforming economy as a whole and a key market

supporting Irish recovery

What are Animal By-products (ABPs)?

Under EU ABP Regulation, defined as: “… bodies or parts of animals or products of animal origin … not

intended for human consumption”

Risk Categorisation of Animal By-products is Key

High risk

Low risk Category 3

Category 1

Category 2Medium risk

Category 1 material: animal by-products presenting• a TSE risk or an unknown risk or • a risk related to treatment with illegal

substances or to environmental contaminants

Category 2 material: animal by-products presenting risk • related to animal diseases or• residues of veterinary drugs

Category 3 material: animal by-products • derived from healthy animals

Risk Categories Explained

(2) Regulatory requirements in biogas plants

Why Regulation of ABPS is Essential

• Disease control - ABP implicated in serious disease outbreaks e.g. BSE, FMD

• €1bn spent on BSE controls • €200 million spent on FMD outbreak

• Avoid contamination of food and feed chain• c€200 million spent on pork dioxin crisis

• Protect ‘Brand Ireland’ & the agri-food industry, esp beef

Legislation governing biogas plants

• Biogas plant using ABPs must be approved

• Legislation:• ABP Regulation (EC) 1069/2009 and 142/2011• National legislation currently being updated

• ‘Conditions document • entitled ‘Conditions for approval and operation of

biogas plants treating animal by-products in Ireland.’

• ABP controls are based on a cumulative risk reduction strategy

• 3 key principles; ABP controls

Safe sourcing

Safe treatment

Safe end-use

ABP controls explained- key details

(1) Safe Sourcing - Overview

Objective:• To prevent any disease risks occuring during transport• To accept into a plant only those ABPs for which any

associated risks can be reduced or eliminated• Traceability of feedstock

Controls:• Transport of feedstock• Permitted feedstocks• Documentation and traceability

Safe sourcing Transport of Feedstock- controls

• ABP hauliers must be registered with DAFF – (some exceptions- e.g. hauliers transporting

catering waste only, or hauliers transporting manure from farm to biogas plant)

• Risk prevention– leak-proof containers or vehicles, clean and dry

before use, washing and disinfection after use, labelling of containers etc

Safe sourcing Permitted Feedstocks - Categories

Category 3 ALL, including; Products/foodstuffs of animal

origin Catering waste (including used cooking oil)

Feathers Milk Cat. 3 material from slaughter

plants Fish and fish products Shells, hatchery by- products,

eggs, egg by-products Processed animal protein-PAP,

(Category 3 material after rendering)

Category 2

Manure Digestive tract and its content Milk, milk based products &

colostrum Eggs and egg products Category 2 material,

following rendering

Safe sourcing Permitted Feedstocks - Acceptance

• Acceptance of feedstocks into a plant depends on;– Processing parameters used in plant– Plant location

• Operator must ensure only permitted feedstocks accepted into the Plant

• Animal by-products from farms (e.g. manure, milk) may not be accepted into a plant if the farm of origin is restricted under the Disease of Animals Act.

Safe sourcing

Documentation and Traceability

• Traceability– Commercial documents accompany ABPs in

transit (some exceptions, e.g. catering waste, manure from farm to biogas

• Plant documentation– e.g. feedstock acceptance agreements,

commercial documents, intake records

(2) Safe Treatment - OverviewObjective:

• To reduce/ eliminate risks in the end- product• To prevent any disease risks escaping off-site

Controls:• Premises- Bio-security controls • Plant lay-out -Basic principles• Processing equipment • Processing standards• Microbiological standards• Hygiene requirements

Safe treatment Premises- Bio-security Controls

• Plant location– Separation from other premises– Adequate separation from farmed animals

• No animal access to plant

• Feedstock must be received into and retained within an enclosed building until processed

Some exceptions to the above, e.g. on-farm biogas plant processing manure/milk from own animals only (‘own ABP’ )- minimum conditions apply.

Safe treatment Plant Lay-out – Basic Principles

• One way flow - dirty to clean

• No by-pass

• Recontamination prevention

• Designated vehicle washing area

• Staff changing/ washing facilities at appropriate locations

Safe treatment Processing Equipment

• Pasteurisation / hygienisation unit which cannot be by-passed

• Installations for monitoring temperature against time• Recording devices- live and real time thermographs• Adequate safety system to prevent insufficient heating• Particle sizing & verification equipment• Installation & equipment maintenance• Measuring equipment calibration

Safe treatment Processing Parameters

• Processing Parameters required dependant upon:• Type of feedstock• Quantity of feedstock in certain cases

• Four Processing standards:• EU processing standard• National processing standard• Alternative processing standard• No specified processing standard

Safe treatment Processing Parameters – Key elements

Processing standards Time Temperature Particle size

EU processing standard60 mins 70 degrees Celsius 12mm or less

National processing standard

48 hrs twice 60 degrees Celsius 400mm or less

Alternative processing standard

Operator must carry out a full risk assessment andvalidation procedure

No specified processing standard

- - -

Verified duringvalidation

Verified duringvalidation

‘Own ABP’

Manure, digestive tract content and milk

Other permitted feedstock +/- manure, digestive tract content & milk

EU processing standard

If ‘outside ‘ manure digestive tract content and milk is > 5000 tpa

Manure, digestive tract content & milk fraction is exempt from processing requirements if ‘outside ABP’ < 5000 tpa

No specified processing standard

If ‘outside ‘ manure digestive tract content and milk is < 5000 tpa

Safe treatment Microbiological Standards

• Representative sampling of digestate

• E.Coli or Enterococaceae – during or immediately after processing/ pasteurisation – indicator of processing efficacy– 5 samples- some tolerance permitted

• Salmonella – during or on withdrawal from storage– indicator of cross-contamination– 5 samples- zero tolerance permitted

• Testing in a DAFF approved laboratory

• Plant procedures for ‘failed’ material and in contact contaminated material

Safe treatment Hygiene Requirements

• ABPs transformed a.s.a.p. after arrival• ABP delivery vehicle cleaning& disinfection• Vermin & pest control procedures• Plant/ equipment cleaning procedures• Personnel hygiene procedures• Digestate handling procedures to prevent

recontamination• Plant dedicated machinery & equipment

Safe treatment Record Keeping – Key Requirements

• Feedstock intake records• Batch processing records- thermographs & particle size

records• Sampling records• Cleaning / hygiene/pest control records• Equipment maintenance & calibration records• Other procedures/ HACCP records

(3) Safe End-Use - Overview

Objective:• To reduce/ eliminate any remaining risks associated

with the end-product

Controls• Storage (on and off site) • Documentation and traceability• End-use restrictions

Safe end-use Storage

Where ?• At plant of origin (approved premises)• End-user premises e.g. farms (no approval

required)• Other premises- (must be approved)

How ?• Under conditions which prevent re-contamination• On-farm- in a storage space to which no farmed

animals have access

Safe end-use Documentation and Traceability

• Dispatch record• when, who, how much etc

• Commercial documents (CD)• except for end-users who are not business operators,

e.g. dispatch to farmers requires a CD, dispatch to hobby gardener does not require a CD

• Grazing and land application restrictions detailed on CD

• ‘End-user’ registration

Safe end-use End-Use Controls – Restrictions

• Grazing restrictions• No restriction for digestate derived from manure only• 21 day grazing restriction (60 days for pigs) for

digestate derived from any other feedstocks

• Crop harvesting restrictions• 3 week restriction on harvesting of crops used for

feedingstuffs for farmed animals

Safe end-use End-Use Controls - Digestate

• Digestate containing unprocessed ABP local landspread

• Digestate processed to the national processing standard use within Ireland (excl.N.Ireland)

• Digestate processed to the EU processing standard can be traded

HACCP & PLANT PROCEDURES• Legal requirement for operator to put in place,

implement & maintain own checks in order to monitor compliance with legislation

• Plant procedures

• HACCP plan –hazards identified and controlled– http://ec.europa.eu/food/food/biosafety/hygienelegislation/

guidance_doc_haccp_en.pdf

• Trained staff

• Records

(3) Plant application and approval process

PLANT APPLICATION AND APPROVAL PROCEDURES

• 2 Stage application procedure

• Plant validation

• Plant approval

1st STAGE APPLICATION1 st stage application

• Location, site and plant plans/ layout

• Biosecurity

• Feedstocks

• Processing parameters

• Technology

2nd STAGE APPLICATION

2nd stage application

• HACCP

• Plant procedures

• Plant validation procedures (validation proposal)

PLANT VALIDATION

• Testing of plant technology• test of the efficacy of the technology • test of reliability and consistency in achieving the

processing parameters

• Operator must comply with legislative/ conditions requirements

• Validation report submission

PLANT APPROVAL

Plant approval subject to;

• Plant compliance with legislation and conditions

• Satisfactory validation

Summary and Conclusions

• Positive outlook for Biogas industry• ABPs a key opportunity, but inherent risks need to

be managed• Adequate and appropriate controls are essential• Positive DAFF/industry consultation will continue• Efficient and effective regulatory process a key

objective• DAFF committed to biogas industry growth and

development

THANK YOU FOR YOUR ATTENTIONTHANK YOU FOR YOUR ATTENTION