Cryoniss now has an APHA licence
Did you know you need to be licensed to use animal containing reagents? Cryoniss is licensed to store category 2 and 3 samples.
The Animal & Plant Health Agency (APHA) is an executive agency of the Department for Environment, Food & Rural Affairs, and also works on behalf of the Scottish Government and Welsh Government.
The agency was launched on 1 October 2014. It merges the former Animal Health and Veterinary Laboratories Agency (AHVLA) with parts of the Food and Environment Research Agency (FERA) responsible for plant and bee health to create a single agency responsible for animal, plant and bee health.
The APHA works to safeguard animal and plant health for the benefit of people, the environment and the economy. Particularly relevant for biological research companies, the APHA enforces several European regulations pertaining to the acquisition, storage, use and disposal of animal-by-products.
Animal-by-products (ABPs) are classified as animal carcasses, parts of animals, or other materials which come from animals but are not meant for human consumption, and include many key reagents in bioscience, for example bovine serum could be a category 3 ABP if the herd has been tested negative for notifiable diseases.
ABP’s are essentially any material (DNA, RNA, protein, tissue, blood etc) isolated directly from an animal, of which humans and invertebrates are excluded as they are regulated via different governmental agencies.
The APHA has classified these further into additional categories, depending upon their risk profile.
Category 1 ABPs
Category 1 ABPs are classed as high risk.
- Carcasses and all body parts of animals suspected of being infected with TSE (transmissible spongiform encephalopathy)
- Carcasses of wild animals suspected of being infected with a disease that humans or animals could contract
- Carcasses of animals used in experiments
- Parts of animals that are contaminated due to illegal treatments
- International catering waste
- Carcasses and body parts from zoo and circus animals or pets
- Specified risk material (body parts that pose a particular disease risk, e.g. cows’ spinal cords)
Category 2 ABPs
Category 2 ABPs are classed as high risk.
- Animals rejected from abattoirs due to having infectious diseases
- Carcasses containing residues from authorised treatments
- Unhatched poultry that has died in its shell
- Carcasses of animals killed for disease control purposes
- Carcasses of dead livestock
- Digestive tract content
Category 3 ABPs
Category 3 ABPs are classed as low risk.
- Carcasses or body parts passed fit for humans to eat, at a slaughterhouse
- Products or foods of animal origin originally meant for human consumption but withdrawn for commercial reasons, not because it’s unfit to eat
- Domestic catering waste
- Shells from shellfish with soft tissue
- Eggs, egg by-products, hatchery by-products and eggshells
- Aquatic animals, aquatic and terrestrial invertebrates
- Hides and skins from slaughterhouses
- Animal hides, skins, hooves, feathers, wool, horns, and hair that had no signs of infectious disease at death
- Processed animal proteins (PAP)
PAP are animal proteins processed from any category 3 ABP except:
- Milk, colostrum or products derived from them
- Eggs and egg products, including eggshells
- Hydrolysed proteins
- Dicalcium phosphate and tricalcium phosphate of animal origin
- Blood products (although any processed blood would still be subject to this guide)
The two key regulations scientific companies need to be aware of are specifically concerned with the transmission of notifiable diseases, for example Transmissible Spongiform Encephalopathies (TSEs), Dioxin contamination, Exotic diseases such as Classical Swine Fever and Foot and Mouth Disease, are:
- Article 23 of regulation (EC) No. 1069/2009 -sites must be registered for use or disposal of Animal By Products (ABP) under 24hr prior notification to DEFRA for ABP importation
- Animal By-Products Enforcement (England) Regulations 2013 (ABPE) – establishments using animal by-products (ABPs) intended for research and diagnostic must be registered by APHA.
Whilst these are European Regulations, post the EU transition these were written into UK law under the European Union (Withdrawal) Act 2018 and so still apply.
In summary, these regulations require companies using ABPs to:
- All sites receiving, storing, processing, transporting or disposing of animal-by-products to hold a site licence with the APHA. Make sure you check box 22 to become established on the European Commission’s approved site register to be authorised to import/export ABP’s with the EEA and EU.
- Monitor all material transfer forms/documentation (intercompany and external collaborators) for all ABP sample transfers
- Ensure compliance with the conditions attached to each licence authorisation ensuring no breeches or non-condition compliance
- Provide 24-hour import notifications to the appropriate APHA office
- Maintain a register of samples imported
- Ensure all declarations are written on headed paper, dated and signed as per conditions
- Provide sample arrival import notifications to the DEFRA State Veterinary Service
- All records and related documentation associated with material imported under the licence authorisations are kept for a minimum of 24 months for possible audit by APHA
For more information check out the Government’s Control on Animal By-Products.