Tse bse что это
Control of TSEs (including BSE and scrapie)
What are TSEs?
Transmissible Spongiform Encephalopathies (TSEs) are a family of diseases occurring in man and animals and are characterised by a degeneration of brain tissue giving a sponge-like appearance leading to death
The commonly accepted cause of the TSE diseases is a transmissible agent called a prion (PrPres), which is an abnormal form of a protein.
EU Legislation
European Parliament and Council Regulation (EC) No 999/2001, known as «the TSE Regulation» is based on sound scientific advice.
The TSE Roadmaps
Two Commission Communications to the European Parliament and the Council, called «TSE roadmaps» have been adopted to inform on revisions to the TSE control system envisaged by the Commission. Most of the short and medium term measures envisaged in these two roadmaps have already been adopted by the Commission.
| July 2005 | TSE Roadmap 1 | Commission Staff Working Document | Questions and Answers |
| July 2010 | TSE Roadmap 2 | Commission Staff Working Document | Press release |
Further information
For all aspects regarding TSEs and BSE, please refer to the information displayed below
For a list of establishments registered/authorised in accordance with Section A of Chapter V of Annex IV to Regulation (EC) No 999/2001, in the context of the feed ban, please visit the List of Establishments page.
For lists of holdings of sheep or goats with a controlled or negligible risk of Classical Scrapie, please visit the Lists of Holdings with a Status for Classical Scrapie page.
TSE/BSE Explained
Bovine Spongiform Encephalopathy (BSE) in bovine animals
Bovine Spongiform Encephalopathy (BSE) is a TSE disease of cattle. BSE was first diagnosed in the UK in 1986, and reached epidemic proportions due to cattle being fed with processed animal protein, produced from ruminant carcasses, some of which were infected. The common symptoms of BSE include behavioural changes, lack of coordination, difficulty in walking or standing up, decreased milk production and weight loss. However, the disease has also been detected in animals showing no symptoms or atypical signs of the disease. The average incubation period of BSE in cattle is 4-6 years, but it can be much longer. BSE is considered to be transmissible to humans. Please refer to vCJD, below.
Nowadays, two forms of BSE are distinguished: Classical BSE, which is transmitted via the feed and was the cause of the BSE epidemics in the 80s, 90s and 2000s; and Atypical BSE (with 2 types of Atypical BSE: the L-type and the H-type), which is considered to be a spontaneous and sporadic disease, not linked to the feed given the animals, occurring at a very low prevalence rate in old bovine animals.
TSEs in sheep and goats
Scrapie is a TSE in small ruminants (sheep and goats) and it can be divided into classical scrapie and atypical scrapie. First recognised more than 250 years ago, it has been known for centuries. It is assumed that scrapie can be transmitted horizontally, from one animal to another or via environmental routes, or vertically, from ewe to lamb / from goat to kid. The clinical signs of scrapie are found predominantly in animals aged from 2 to 5 years and include weight loss, salivation, pruritus and associated hair loss and skin abrasions, incoordination of hind limbs and altered behaviour such as observed nervousness, depression, excitability or aggressiveness. On the basis of the available scientific data scrapie is not considered to be transmissible to humans.
BSE has once been detected in a goat in the EU wide surveillance programmeBSE has once been detected in a goat in the EU wide surveillance programme designed to detect suspicious TSE strains in sheep and goats. The case was confirmed in January 2005 by the EU Reference Laboratory (EURL) for TSEs and it concerned a goat slaughtered in France in 2002. The goat was disposed of after slaughtering as well as its entire herd and did not enter the food chain. In addition, retrospective testing of a Scottish goat culled in 1990s gave results indicative of BSE and the EURL for TSEs concluded in May 2009 that BSE cannot be excluded. Following the French BSE case detected in a goat, the European Commission advised no change in the current consumption of goat milk, cheese and meat. EU food safety rules ensure that only products from healthy animals are allowed to enter the food chain and the food placed on the market is safe. As an additional safety measure the specified risk material (the tissues most likely to carry infectivity if TSE is present) are also removed from all goats. Since then, no other case of BSE have been detected in goats. Furthermore, BSE has never been detected in sheep.
Chronic Wasting Disease (CWD)
Chronic Wasting Disease (CWD) is a TSE disease of cervids (deer, elk and moose). The symptoms of CWD are a loss of body condition («wasting») and behavioural abnormalities such as staggering and poor standing posture. CWD has never been detected in Europe, but is quite common in North America (USA and Canada) and has been detected in Norway for the first time in April 2016. Though CWD belongs to the same family as BSE and scrapie, there is no known relationship between CWD and other TSEs in animals or humans under natural conditions.
Variant Creutzfeldt-Jakob Disease (vCJD)
Variant Creutzfeldt-Jacob Disease (vCJD) is a TSE disease in humans. vCJD was first diagnosed in 1996. It is now generally assumed to be caused by the transmission of the BSE agent to humans by the oral route. vCJD occurs mostly in young people and most cases have occurred in the UK, although there have been cases also in France, Ireland, Italy, the Netherlands, Portugal and Spain in the EU and in the USA, Canada, Saudi-Arabia, Taiwan and Japan in non-EU countries. So far 220 vCJD cases have been detected in European countries (177 in the UK), and 9 cases outside the EU. At present the cCJD epidemic seems to be vanishing.
Legislation
The Commission introduced the first EU legislation on BSE in July 1989. By the middle of 1990, basic EU legislation on BSE was in place concerning meat and live cattle. Today, Regulation (EC) No 999/2001 (» the TSE Regulation») forms the legal basis for almost all legislative actions on TSEs. It gathers together all BSE measures adopted over the years into a single, comprehensive framework consolidating and updating them in line with scientific evidence and international standards. It has been amended many times in response to the evolution of the BSE situation, new or updated scientific advice and/or technological developments. The purpose of the TSE legislation is to protect the health of consumers and animals and to control and eradicate TSEs. In addition, according to the EU hygiene legislation (Regulation (EC) No 854/2004), all animals presented for slaughter must undergo a veterinary inspection (ante mortem) to ensure that suspected cases do not enter the food and feed chain.
The main provisions of the TSE Regulation can be summarised as follows:
Monitoring
Since May 1998, EU-wide measures on surveillance have been in place. See Annexes III and X to the TSE Regulation. See topics Monitoring and Diagnostics
Feed ban
The feed ban is the basic preventive measure laid down against BSE and consists of a ban on the use of processed animal protein (PAP) in feed for farmed animals. PAP produced from infected ruminants is assumed to be the transmission route of BSE. See Annex IV to the TSE Regulation. See topic Feed Ban
Specified risk material
Another equally important preventive measure is the removal of Specified Risk Material (SRM) from cattle, sheep and goats so it doesn’t enter the food and feed chain (since October 2000). SRM are the tissues where BSE infectivity is most likely to occur. The list of SRM to be removed for bovine animals depends on the BSE risk status of the country of origin. See Annex V to the TSE Regulation, where SRM for both bovine animals and for ovine and caprine animals are listed in detail.
Determination of BSE status: Classification
The BSE status of Member States or third countries or regions thereof is to be determined by classification into one of three categories depending on the BSE risk involved: a negligible risk, a controlled risk and an undetermined risk. This classification is based on that of the World Organisation for Animal Health (OIE) since July 2007, and is laid down in Commission Decision 2007/453/EC, which is regularly amended. The BSE status of EU Member States and EFTA countries according to Commission Decision 2007/453/EC as last amended is summarised on the linked map.
Breeding Programmes
Member States may introduce breeding programmes to select for resistance to TSEs in their ovine populations. It has been shown that sheep of a certain genotype are more resistant to scrapie. See Annex VII to the TSE Regulation.
Control and Eradication of TSEs
The TSE Regulation lays down culling and eradication measures in relation to TSE cases. Whenever TSE is suspected in a holding, the competent authority must be notified and the holding must be put under official control including moving restrictions until the final testing results are available. If TSE is confirmed, the entire body of the animal concerned must be disposed of by incineration. An inquiry to identify all animals at risk of having TSE must be carried out. For BSE, all animals at risk must be culled and disposed of as well as the products derived from them. See Annex VII to the TSE Regulation.
Placing on the market, export and import
Rules on trade are laid down for live animals, their semen, embryos and ova as well as products of animal origin. See Annexes VIII and IX to the TSE Regulation. See the topic Impact on trade.
Feed Ban
The feed ban is the basic preventive measure laid down against TSE and consists of a ban on the use of processed animal protein (PAP) in feed for farmed animals. Findings by the scientific committees linked the spread of BSE to the consumption of feed contaminated by the infected ruminant protein in the form of PAP. In other words, PAP produced from ruminant carcasses, some of which were infected, was assumed to be the transmission route of BSE. Based on these findings a ban on the feeding of mammalian processed animal protein to cattle, sheep and goats was introduced in July 1994. The ban was expanded in January 2001 with the feeding of all processed animal proteins to all farmed animals being prohibited, with certain limited exceptions. This is to ensure that there is no cross-contamination between feed containing PAP intended for species other than ruminants and feed intended for ruminants. Only certain animal proteins considered to be safe (such as fishmeal) can be used, and even then under very strict conditions.
The existing derogations provided for in Annex IV to the TSE Regulation are summarised here. They are based on strict channelling requirements (to avoid the cross-contamination, in particular between materials for which derogation to the feed ban is provided for feed intended to non-ruminant animals only, and feed intended to ruminants, and between prohibited ruminant materials and feed for farmed animals).
Official controls must be carried out by the Member States’ competent authority to verify the correct application of the feed ban, based on laboratory analytical methods, as laid down in Annex I and Annex VI to Regulation (EC) No 152/2009. The validation of analytical methods for the official controls of the feed ban is carried out by the EU Reference Laboratory (EURL) for Animal Proteins in Feedingstuffs, which also organises interlaboratory studies to ensure the excellence of performance of National Reference Laboratories (NRL).
The EU feed ban provisions are reviewed regularly based on EFSA opinions and the development of new analytical methods for official controls. As regards scrapie, Annexes VII to the TSE Regulation bans the use as feed of milk and milk products coming from classical scrapie infected flocks for feeding ruminants.
For a list of establishments registered/authorised in accordance with Section A of Chapter V of Annex IV to Regulation (EC) No 999/2001, please visit the List of Establishments page.
Monitoring
Adequate surveillance forms the basis for other TSE control and eradication measures as it allows to have a reliable knowledge of the epidemiological situation. Since May 1998, EU-wide measures on surveillance have been in place. Each Member State has to carry out an annual monitoring programme for TSEs based on active surveillance (testing without previous suspicion) and passive surveillance (testing of clinical suspects identified by veterinarians/farmers) which applies to both bovine animals and ovine and caprine animals. The monitoring programme provides a reliable insight into the prevalence and evolution of TSEs in the Member States and at the same time ensures that no BSE cases are being slaughtered for human consumption. See Annexes III and X to the TSE Regulation.
BSE-monitoring of bovine animals
The active surveillance covers testing of two categories of bovine animals:
However, based on a favourable epidemiological situation most Member States have been authorised to apply a revised annual BSE monitoring programme and test only risk animals over 48 months of age provided that the animals have been born in those Member States. The list of Member States authorised to apply a revised annual BSE monitoring programme is laid down in Commission Decision 2009/719/EC.
The passive surveillance consists of testing animals identified as BSE suspects by the veterinarian or the farmer.
TSE monitoring of ovine and caprine animals
The active surveillance covers testing of three categories of sheep and goats:
The passive surveillance consists of testing animals identified as TSE suspects by the veterinarian or the farmer. See Annex III to the TSE Regulation.
TSE monitoring in other animal species
A survey for chronic wasting disease (CWD) in cervids was carried out during 2006-2008. See Commission Decision 2007/182/EC. No positive cases were found at the time.
The TSE Regulation includes a provision requiring the examination of TSE suspicions in all animal species, including cervids. Active monitoring in species other than bovine, ovine, caprine and cervid animals is voluntary and without further specifications. In case of detection of a positive TSE case, the animal must be culled and destroyed by incineration.
Report and Studies
Tse bse что это
ГОСТ Р ИСО 22442-1-2011
НАЦИОНАЛЬНЫЙ СТАНДАРТ РОССИЙСКОЙ ФЕДЕРАЦИИ
ИЗДЕЛИЯ МЕДИЦИНСКИЕ, ИСПОЛЬЗУЮЩИЕ ТКАНИ И ИХ ПРОИЗВОДНЫЕ ЖИВОТНОГО ПРОИСХОЖДЕНИЯ
Medical devices utilizing animal tissues and their derivatives. Part 1. Application of risk management
Дата введения 2012-03-01
Сведения о стандарте
1 ПОДГОТОВЛЕН Автономной некоммерческой организацией «Институт медико-биологических исследований и технологий» (АНО «ИМБИИТ») на основе собственного аутентичного перевода на русский язык текста стандарта, указанного в пункте 4
2 ВНЕСЕН Техническим комитетом по стандартизации ТК 422 «Оценка биологического действия медицинских изделий»
При применении настоящего стандарта рекомендуется использовать вместо ссылочных международных стандартов соответствующие им национальные стандарты Российской Федерации, сведения о которых приведены в дополнительном приложении ДА
Введение
Международные стандарты разрабатываются в соответствии с правилами, приведенными в Директивах ИСО /МЭК, часть 2.
Основной задачей Технических комитетов является подготовка международных стандартов. Проекты международных стандартов, принятые Техническими комитетами, распространяются организациям-членам для голосования. Публикация в качестве международного стандарта требует одобрения не менее 75% организаций-членов с правом голоса.
Необходимо обратить внимание на возможность того, что некоторые элементы данного документа могут подвергаться патентным правам. ИСО снимает с себя ответственность за обозначение каких-либо таковых патентных прав.
ИСО 22442-1 был подготовлен Техническим комитетом ИСО/ТС 194 «Биологическая оценка медицинских изделий», Подкомитет ПК 1 «Безопасность изделий из животной ткани».
ИСО 22442 состоит из следующих частей под общим наименованием «Изделия медицинские, использующие ткани и их производные животного происхождения»:
— Часть 1: Менеджмент риска;
— Часть 2: Контроль отбора, сбора и обработки;
— Часть 3: Валидация уничтожения и/или дезактивации вирусов и агентов инфекционной губчатой энцефалопатии (TSE).
1 Область применения
1.1 Настоящий стандарт распространяется на медицинские изделия, за исключением диагностических медицинских изделий in vitro, изготовленных с использованием материалов животного происхождения, являющихся нежизнеспособными или приведенными в нежизнеспособное состояние.
Настоящий стандарт в сочетании с ИСО 14971 определяет процедуру для установления опасности и опасных ситуаций, связанных с такими изделиями, для расчета и оценки возможного риска, контроля такого риска и наблюдения за эффективностью такового контроля. Также настоящий стандарт устанавливает процесс принятия решения для допустимости остаточного риска, учитывая баланс остаточного риска, как определено в ИСО 14971, и ожидаемое медицинское преимущество по сравнению с существующими альтернативами.
1.2 Предназначением настоящего стандарта является предоставление требований и рекомендаций по контролю риска, связанного с опасностями, характерными для медицинских изделий, произведенных с использованием животных тканей или их производных, такими как:
a) контаминация бактериями, плесневыми или дрожжевыми грибами;
b) контаминация вирусами;
c) контаминация агентами, вызывающими инфекционные губчатые энцефалопатии (TSE);
d) материал, вызывающий нежелательные пирогенные, иммунологические или токсикологические реакции.
Схожие принципы могут быть применимы для паразитов и других неклассифицированных патогенных единиц.
1.3 Настоящий стандарт не устанавливает допустимые уровни, так как таковые определяются множеством факторов и не могут быть зафиксированы в настоящем стандарте, за исключением некоторых отдельных производных, отмеченных в приложении С. В приложении С установлены допустимые уровни риска TSE для производных жира, животного угля, молока и производных молока, производных шерсти и аминокислот.
Настоящий стандарт не определяет систему контроля качества для регулирования всех стадий производства медицинских изделий.
Настоящий стандарт не касается использования тканей человека в медицинских изделиях.
1 Наличие полной системы контроля качества во время производства не является требованием настоящего стандарта. Тем не менее, обращено внимание на международные стандарты для систем контроля качества (см. ИСО 13485), регулирующие все стадии производства или переработки медицинских изделий.
2 Для рекомендаций по применению настоящего стандарта см. приложение А.
2 Нормативные ссылки
Следующие справочные документы* являются необходимыми для применения данного документа. При датированной ссылке применимо только указанное издание. При ссылке без даты применимо последнее издание указанного документа (включая любые поправки).
ИСО 10993-1 Биологическая оценка медицинских изделий. Часть 1. Оценка и испытания
ИСО 14971:2007 Изделия медицинские. Применение менеджмента рисков к медицинским изделиям
ИСО 22442-2:2007 Изделия медицинские, использующие ткани и их производные животного происхождения. Часть 2. Контроль отбора, сбора и обработки
ИСО 22442-3:2007 Изделия медицинские, использующие ткани и их производные животного происхождения. Часть 3. Валидация уничтожения и/или дезактивации вирусов и агентов инфекционной губчатой энцефалопатии
3 Термины и определения
В настоящем стандарте применены термины по ИСО 14971, а также следующие термины с соответствующими определениями:
3.1 животное: Любое позвоночное или беспозвоночное [включая земноводных, членистоногих (например, ракообразных), птиц, кораллы, рыб, рептилий, моллюсков и млекопитающих] за исключением человека (Homo sapiens).
3.2 клетка: Наименьшая организованная единица любой живой формы, способная к независимому существованию и к возмещению собственного вещества в подходящей среде.
3.3 производная: Вещество, полученное на основе животного материала путем производственного процесса (пример: гиалуроновая кислота, коллаген, желатин, моноклональные антитела, хитозан, альбумин).
3.4 уничтожение: Процесс удаления, путем которого сокращается число передающихся агентов.
3.5 дезактивация: Процесс, посредством которого сокращена способность передающегося агента вызывать инфекцию или патогенную реакцию.
3.6 медицинское изделие: Любой прибор, аппарат, приспособление, материал или другое изделие, включая программное обеспечение, используемое либо изолированно, либо в комбинации, которое предназначено изготовителем для применения, главным образом, в следующих целях:
— диагностика, профилактика, наблюдение, лечение или облегчение болезни;
— диагностика, наблюдение, лечение, облегчение или компенсация повреждения органов или физического недостатка;
— исследование, замена или изменение анатомии или физиологического процесса;
и которое не является фармакологическим, иммунологическим или метаболическим средством, но может быть дополнено такими средствами.
1 Данное определение было выработано Специальной Группой по Глобальной Гармонизации (GHTF) [39].
2 ИСО 22442 не применим к диагностическим изделиям in vitro.
3.7 нежизнеспособный: Не имеющий потенциала к метаболизму или размножению.
3.8 техническое соглашение: Обязательственный договор между двумя или более сторонами, распределяющий ответственность за технические требования.
3.9 ткань: Построение клеток и/или внеклеточных составляющих.
4 Процесс контроля риска
Изготовитель должен обосновать использование животного материала (включая выбор видов животных и тканей), опираясь на приемлемость остаточного риска, учитывая баланс остаточного риска и ожидаемого медицинского преимущества по сравнению с существующими альтернативами.
Применимы требования ИСО 14971 и 4.2-4.5. Соответствие данным требованиям должно быть подтверждено инспекцией документации по контролю риска.
4.2 Анализ риска
4.2.1 Установление качественных и количественных характеристик, связанных с безопасностью медицинских изделий
4.2.1.1 Способ контакта изделия с тканями пациента
Количество материала, площадь контактной поверхности и тип материала, контактирующего с тканями тела или жидкостями, а также тип ткани организма или жидкости, с которыми происходит контакт, должны быть предусмотрены в анализе риска. Рекомендации для TSE приведены в D.3.7.
1 Медицинские изделия, такие как ортопедическая обувь или компоненты, такие как кожаные ремни, которые контактируют только с неповрежденными кожными покровами, представляют низкий инфекционный риск.
2 Количество контактирующего материала является одним из факторов при определении биологических эффектов (см. ИСО 10993 для оценки таких эффектов).
What is a BSE/TSE Certificate and Why Should You Care?
Categories
TSE Certificates come packaged with products that could potentially have TSE risk, such as BSA (Bovine Serum Albumin), but many people don’t know what they mean or why they’re so important.
If you’re shopping for bovine-derived reagents for your research, you’ve probably come across a mention about being ”TSE Compliant” quite a few times, but wondered what that meant or why it matters. I’ll discuss what it means to be TSE (Transmissible Spongiform Encephalopathy) compliant and why TSE certificates are so important.
TSE compliance certificates are a type of CEP (Certificate of Suitability to the European Pharmacopoeia). They are used to maximize safety when working with materials that could potentially be contaminated with TSE. Any material with a TSE CEP has been confirmed by the European Directorate for the Quality of Medicines to be suitably controlled by the relevant monographs established by the European Pharmacopoeia. What this means is that the substance is compliant with the standard measures used to minimize the risk of TSE contamination. These CEPs are recognized by members of the European Pharmacopoeia as well as institutions in other countries such as the FDA in the United States. Minimizing the risk of TSE contamination in products like GoldBio’s Bovine Serum Albumin is extremely important to human safety, but why?
TSEs are diseases caused by prions which lead to degeneration of the nervous system. Some examples of TSEs include Creutzfeldt-Jakob disease, scrapie in sheep and bovine spongiform encephalopathy (commonly referred to as mad cow disease). These illnesses have existed for quite a long time, with the first documentation of them occurring centuries ago.
In the 1980s, when the first TSE epidemic occurred, scientists began focusing more of their time and effort to understand these conditions. In the UK, it was discovered that cattle were being fed with a supplement containing dead sheep, supporting the theory that bovine spongiform encephalopathy arose due to ingestion of scrapie-infected sheep. Rules and regulations began to be put in place by the governing bodies in the UK and research of the topic continued to increase. By 1996, a link between the human form of mad cow disease, Creutzfeldt-Jakob disease, and BSE from ingestion of beef was found.
With the link between BSE and Creutzfeldt-Jakob being discovered, scientists confirmed that horizontal transmission of TSEs from animals to humans can occur. This is of great concern when working with certain animal-derived reagents in the lab because there is currently no cure or treatment for TSEs. With an incubation period of months to decades, the nervous system is highly affected at the time of prion disease diagnosis. Once symptoms become apparent, prognosis is not good—patients usually die within months to a few years.
Although the prevalence of TSEs is low globally, it is important to take precautions to ensure their spread is minimized. Many scientists work directly with products derived from bovine serum and this would be reason for concern if TSE compliance had not been developed.
It is important to remember, however, that many materials used in labs are synthetic or derived from animal tissues that do not pose a risk of contracting a prion disease so not all products will be TSE certified. It is important, however, to ensure TSE compliance when purchasing products like BSA, especially if purchasing from Europe or other countries where there is a higher risk of TSE contamination.
Next time you see a TSE Certificate when opening a new shipment of Bovine Serum Albumin from GoldBio, you can be glad to know that it is TSE CEP certified. Our BSA is protease and certified TSE CEP compliant, manufactured in the United States in a closed loop system from USDA-inspected, healthy animals.
References:
Ramachandran, T. S., et. al. (2014, October 27). Prion-Related Diseases. Retrieved June 17, 2016, from http://emedicine.medscape.com/article/1168941-overview#a6
 Rebecca Talley GoldBio Staff Writer |
Category Code: 79104, 79107, 79108, 79109