290/2008 Coll.
DECREE


Dated 6 August 2008

On animal health requirements for aquaculture animals and
aquaculture products, the measures for prevention and eradication
certain diseases in aquatic animals

Change: 59/2013 Coll.

Change: 134/2014 Coll.

Ministry of Agriculture, pursuant to § 78 of Act no. 166/1999 Coll., On
veterinary care and amending certain related laws (Veterinary
Act), as amended by Act no. 131/2003 Coll., Act No. . 316/2004 Coll., Act No.
. 48/2006 Coll. and Act no. 182/2008 Coll., (hereinafter the "Act") to implement
§ 5, paragraph. 3 point. a) and c), § 5a. 4, § 6. 11 point. a) § 8 paragraph
. 5, § 10 paragraph. 3, § 22 paragraph. 2, § 34 para. 5 point. a) § 37 para. 5
point. a) § 51a paragraph. 3 and § 53 par. 6 point. b) and c) of the Act:
PART ONE


HEALTH REQUIREMENTS OF AQUACULTURE ANIMALS AND
aquaculture products and measures for prevention and control of certain

DISEASES OF AQUATIC ANIMALS TITLE
I
PRELIMINARY PROVISIONS


§ 1
Subject Matter


(1) This Decree implements the relevant regulations of the European Union ^ 1) and
following the directly applicable European Union regulations ^ 2) (hereinafter
"the European Union") provides

A) veterinary and health requirements for animals originating from aquaculture
, their breeding and protection against infection and disease
transmitted from animals to humans, placing on the market and imports, as well as
the discharge of aquatic fauna to production
aquaculture enterprises,

B) the health requirements for products derived from animals
aquaculture and handling, as well as specific requirements
imports of these products from third countries

C) measures for the prevention and control of certain diseases in aquatic animals
.

(2) This Decree does not apply to

) Ornamental aquatic animals reared in non-commercial aquaria,

B) wild aquatic animals harvested or caught for their direct
into the food chain,

C) aquatic animals caught for the purpose of production of fishmeal, fish feed,
fish oil and similar products.

(3) The provisions of § 3-15 and § 38 to 42 shall not apply if
ornamental aquatic animals are kept in pet shops
used for livestock farms, garden centers, garden ponds or commercial || | aquaria or wholesalers in facilities that

A) do not come into direct contact with surface water in the European Union
(hereinafter referred to as "the Union"), or

B) are fitted as standard treatment or disposal of waste water,
which reduces the risk of transmitting diseases to the waters referred to in subparagraph a)
to an appropriate level.

(4) This Decree shall not affect the provisions ^ 3)
concerning the protection of species or the introduction of non-native species.

§ 2


Definitions
(1) For the purposes of this Decree

A) aquaculture breeding or keeping of aquatic organisms using procedures
designed to increase the production of the organisms beyond the natural capacity of the environment
, these organisms remain the property
one or more natural or legal persons throughout
breed or holding until their collection or hunting

B) aquaculture animal means any aquatic animal at
all its life stages, including eggs and sperm, or gametes,
reared in a farm or mollusc farming area, as well as any aquatic animal originally
wild intended for a farm
or mollusc farming area

C) aquaculture production business by any undertaking which carries
any activities related to the rearing, keeping or breeding animals
aquaculture

D) aquaculture production business operator
any natural or legal person who is responsible for ensuring that the requirements of this Decree
are observed in aquaculture production business, which is under the control of
,

E) aquatic animal

First Fish Agnatha superclass and classes Chondrichthyes and Osteichthyes,

Second Tribe Mollusca mollusk,

Third crustacean subphylum Crustacea,

F) authorized treatment facilities by any
processing facility, which has been approved and registered under the Act and Regulations

European Union ^ 4) for processing aquaculture animals for food purposes
,

G) authorized processing equipment
any natural or legal person who is responsible for ensuring that the requirements of this
decree are met within the authorized processing establishment, which is
under its control,

H) breeding rearing of aquaculture animals in the farm
or mollusc farming area

I) mollusc farming area production area or relaying area in
which all aquaculture production businesses operate within
common biosecurity system,

J) production areas all areas in fresh and marine waters, while
estuaries and lagoons where the molluscs are naturally occurring or where
artificially bred and where they are collected and

K) fishing put and Slovakia (hereinafter referred to as "fishing area")
pond or other facility where the animal population
originating from aquaculture keeps their planting only for recreational
fishing | ||
L) relaying areas, each area in fresh and marine waters, while
estuaries and lagoons with boundaries clearly marked by buoys,
poles or other fixed means, which is designed exclusively for the natural purification
live molluscs,

M) ornamental aquatic animal aquatic animal which is kept, reared, or
placed on the market for ornamental purposes only,

N) wild aquatic animal aquatic animal which is not
aquaculture animal.

(2) In addition, for the purposes of this decree means

A) units of one or more farms under a common biosecurity system
, which is held stocks of aquatic animals with
distinct health status with respect to a specific disease,

B) a common biosecurity system to apply the same
measures concerning supervision of aquatic animal health, prevention and disease control
,

C) restricted zone area around the infected farm or farming area
shellfish, which are applied disease control measures to prevent the spread of
,

D) diseases in aquatic animals (hereinafter the "contagion")
clinical or non-clinical infection with neprojevující aquatic animals with one or more
aetiological factors

E) zone or compartment free from infection zone or recognized
free according to the Act and § 38 or 39 of this Decree,

F) emerging diseases newly identified serious disease, whose
cause may not be known, which may spread within
between populations, such as through trade in aquatic animals or
products derived from aquatic animals. Means
It also plague mentioned in the list of diseases that were found in
new host species not yet listed in Part II of Annex no. 3 to
this decree as a sentient species,

G) epidemiological unit group of aquatic animals with
approximately the same risk of exposure to a disease agent in a certain location.
This risk may be because they share a common aquatic
environment, or that could result in husbandry practices
pathogen is likely to spread rapidly from one group to the other animals
, || |
H) the further processing of the processing of aquaculture animals
before human consumption by any type of measures and procedures that
affecting the anatomical integrity of these animals, such as
bleeding, gutting, gutting, separating heads from body
slicing and filleting, and that produce wastes and by-products
, which could cause a risk of spreading diseases,

I) increased mortalities unexplained mortalities significantly above the level that can be
prevailing circumstances be regarded as normal for the
farm or the mollusc farming area; what is considered
be increased mortality must be decided breeder and regional
Veterinary Administration

J) infection presence multiplying, or otherwise developing, or
latent disease agent in the host or host

K) the infected area or unit of area or unit of which is
known that to occur infection


L) quarantine holding separate group of aquatic animals
without any direct or indirect contact with other aquatic animals, in order
their observation for a specified period of time, and if necessary,
their examinations and treatment, including treatment or disposal of waste
water

M) susceptible species, any species in which infection has been demonstrated
pathogens, which occurred naturally or experimentally
simulating the natural routes of infection,

N) carrier species that is not susceptible to infection, but the infection can spread
carrying the pathogen from one host to another,

O) areas a precise geographical area with a homogeneous hydrological
system comprising part of a catchment area from its source to a natural or
artificial barrier that prevents the migration of aquatic animals from the lower stretches of the river basin
upstream, whole catchment area from the source to the mouth
into the sea, or more than one water catchment area, including their estuaries, in
due to the epidemiological link between the catchment areas through the estuary
.

(3) Where this decree speaks about the economy, it is understood that any
spaces, enclosed area or equipment operated production now
aquaculture in which aquaculture animals
bred for their placing on the market, with the exception of those areas
areas or establishments where wild aquatic animals,
collecting and hunting for human consumption temporarily kept before killing without
would be fed.

(4) Where this decree speaks of putting on the market, it is understood
sale, including offering for sale, or any other form of transfer
for consideration or without consideration, and any form of relocation of animals || | aquaculture.

(5) For the purposes of this Order shall apply, as appropriate,
definitions contained in the regulations of the European Union concerning the general principles and requirements of food law
, the hygiene of foodstuffs, specific hygiene rules for food of animal origin
and official controls on feed and food
rules on animal health and welfare ^ 5).
TITLE II


HEALTH AND HEALTH REQUIREMENTS FOR ANIMALS COMING FROM
AQUACULTURE AND aquaculture products
Part 1


Aquaculture production businesses and authorized processing establishments

§ 3

(1) aquaculture production businesses and authorized processing equipment,
in which aquaculture animals killed in the context of
disease control in accordance with § 23 must have its veterinary approval
number under which They were approved, and under which they are kept in the list of authorized and registered
aquaculture production businesses and authorized processing establishments
.

(2) In the case of shellfish, the veterinary approval number
cover several aquaculture production businesses in one area
breeding shellfish. Dispatch centers, purification centers and
similar devices located inside a mollusc farming area,
however, must be approved separately and each must have its own
veterinary approval number.

(3) Only registration is subject

A) other devices than aquaculture production businesses, which are kept
aquatic animals that are not destined to be placed on the market

B) fisheries restocking and Slovene,

C) aquaculture production businesses, which include animals originating from aquaculture
on the market solely for human consumption, so that
in small quantities are sold directly to the final consumer or to local supply
retail stores, which directly supplies
final consumer.

(4) For the cases referred to in paragraph 3, the provisions of this Decree
similarly with respect to the type, characteristics and location of the respective
equipment, fishing areas and planting Slovene or company and
risk of spreading diseases aquatic animals to other populations of these animals
due to the loss of such a device, fisheries and planting
Slovene or enterprise.

§ 4

(1) Application for approval and registration of aquaculture production business or authorized processing
must contain the next data set
law also data listed in Annex no. 1 hereto.


(2) Changes to the data provided in the application referred to in paragraph 1 shall be notified
Regional Veterinary Administration without undue delay.

§ 5

List of approved aquaculture production businesses and authorized
processing plants must contain the information specified in Annex no. 1 to
hereto.

§ 6

(1) The Regional Veterinary Administration carries out in all farms and mollusc farming areas
state veterinary health surveillance
aquaculture animals based on the degree of risk and
corresponding to the type of production. Its main aim is to determine

A) any increased mortality in aquaculture animals in
farms and mollusc farming areas with regard to that type
production

B) the occurrence of diseases listed in Part II of Annex no. 3 hereto in
farms and mollusc farming areas where they are bred or kept
species susceptible to these diseases.

(2) Official controls on aquaculture production businesses and authorized processing establishments
mainly consist of regular inspections,
visits and audits; when carrying out official controls
Regional Veterinary Administration shall proceed in accordance with European Union regulations governing
specific rules for the organization of official controls on products
animal origin intended for human consumption and
official controls on feed and food law health and animal welfare ^ 6).

(3) Regional Veterinary Administration is based upon

A) determining the frequency of checks carried out under the state veterinary supervision
under paragraphs 1 and 2 of the health status
relevant area or unit and the degree of risk the aquaculture production business
or authorized processing establishment poses a | || terms of potential introduction and spread of diseases, as well as recommendations
listed in Annex no. 2 hereto,

B) evaluation of health status, level of risk and determining the specific
means of exercising state veterinary supervision of the recommendations set out in Annex
no. 2 hereto.
Part 2


Veterinary requirements for the placing of aquaculture animals and products
thereof on the market
General requirements


§ 7

(1) Aquaculture animals and products derived from them
may be placed on the market if their placing on the market, especially if
associated with their moving between EU Member States (hereinafter || | "Member state"), zones and compartments with different health statuses
listed in part a of Annex no. 2 hereto,
not jeopardize the health status of aquatic animals at the place of destination or at places of transit
terms about the disease and they are susceptible species listed in part II of Annex.
3 hereto.

(2) Aquaculture animals and products derived from them
may be placed on the market for scientific purposes, although
meet the requirements specified in the provisions of Parts 2 and 3, if not jeopardize the health status of aquatic
animals in places of destination or at places of transit, regarding
diseases listed in part II of Annex no. 3 hereto.
In this case, however, their marketing is subject to supervision by an official veterinarian and
must be notified in advance to the competent authorities of the Member States concerned
.

§ 8

(1) Aquaculture animals must be accompanied by a health certificate
if placed on the market in
Member State, zone or compartment in accordance with § 38 and 39 are recognized as being free
infection, or subject to surveillance program or program
sanitation according to § 34 para. 1 or paragraph. 3, in order

A) farming or restocking, or

B) further processing before human consumption, unless the fish are not
slaughtered and eviscerated before dispatch, or if
molluscs and crustaceans, they are dispatched as unprocessed or processed products.

(2) The veterinary certificate must be accompanied by animals also
aquaculture, which are placed on the market in areas subject
extraordinary veterinary measures that were in line with
§ 22-31 enacted to combat diseases listed in part II of Annex no. 3 to
hereto as well as to combat other diseases to which they are susceptible
animals.


(3) Relocation of aquaculture animals to which
requires a health certificate referred to in paragraphs 1 and 2, as well as
movements of those animals between Member States for farming or restocking
to which not according to this decree required
veterinary certificate shall be notified through the integrated computerized system for veterinary
Union institutions.

(4) Transport of aquaculture animals must comply with
requirement of the Law on the prevention of diseases should take place in
measures to ensure that there is a change in health status
transported animals and animal health status at the place of destination
, or in places of transit, and to reduce the risk of spreading disease
. This applies also to infections and they are susceptible species not listed
in Part II of Annex no. 3 hereto.

(5) Replacement of water during the transport of animals relocated
aquaculture must be carried out at places and under such conditions
to avoid jeopardizing the health status

A) relocated aquaculture animals,

B) any aquatic animals at the place of water exchange and the destination.

Requirements for the placing of aquaculture animals on the market for
for farming and restocking

§ 9

(1) Aquaculture animals may be placed on the market for breeding purposes
if they are clinically healthy and do not come from
farms or mollusc farming area where there is any unresolved increased mortality
, and not only with regard to the disease, and they
susceptible species listed in part II of Annex no. 3 hereto, but also
with regard to the disease, and for them susceptible species not listed there.
This does not affect the provisions of Title III.

(2) Based on the assessment of the risks may
regional veterinary authority to consent to be placed on the market and animals who
come from that part of the farm or mollusc farming area that is
independent of the epidemiological unit where the increased mortality.

(3) Aquaculture animals who are destined to
disposal or death of the extraordinary
veterinary measures ordered for disease control in accordance with § 18 to 33
not be placed on the market for farming and restocking.

§ 10

Aquaculture animals may only be released into
surface waters for restocking purposes or into fishing areas
planting and Slovakia, where the corresponding requirements set out in § 9
paragraph. 1 and come from a farm or mollusc farming area
health status as referred to in Part A of the Annex no. 2 hereto
is at least equivalent to the health status of the waters into which they are released
.

§ 11

The placing of aquaculture animals and
belonging to species susceptible to a specific disease on the market in the state, zone or compartment disease-free


(1) Aquaculture animals and species susceptible to a specific disease
may be placed on the market for farming or restocking
into a Member State, zone or compartment, which are recognized in accordance
with § 38 or 39 to be free to the disease only if they
animals from another Member State, zone or compartment
which are also recognized as free from the disease.

(2) If the authorities of the Union, that certain species susceptible to infection in her
certain life stages do not transmit, the provisions of paragraph 1,
this stage of their life do not apply.

§ 12

Placing live aquaculture animals and belonging to
vector species to the market in the state, zone or compartment disease-free

If foreseen Union authorities that species not listed in Part II of Annex
no. 3 hereto may be used as carriers
responsible for the transmission of certain diseases can be such vector species placed on the market
for the purpose of farming or restocking into a Member State or region
units, which are recognized in accordance with § 38 or 39 free
to the disease only if

A) originate from another Member State, zone or compartment
are also recognized as being free of the disease, or


B) be held in quarantine in water free agents this disease for a period
which is based on scientific knowledge and practical experience
sufficient to reduce the risk of transmission of this disease to a level acceptable in terms of preventing its transfer
.

§ 13

Aquaculture animals and products derived from them, who
intended for human consumption and are placed on the market for further processing before

human consumption
(1) Live aquaculture animals and
belonging to species susceptible to one or more non-exotic diseases listed in Part II of Annex
no. 3 hereto and products derived from them may be || | Member State, zone or compartment that is in accordance with § 38 or 39
recognized as being free from those diseases, placing on the market for further processing
if they meet one of the following conditions:

A) originate from another Member State, zone or compartment
recognized as free from the relevant disease

B) they are processed in an authorized processing establishment under conditions
prevent the spread of diseases, or

C) before sending slaughtered and eviscerated, if it is a
fish, or are dispatched as unprocessed or processed products
when it comes to shellfish.

(2) Live aquaculture animals and
belonging to species susceptible to one or more non-exotic diseases listed in Part II of Annex
no. 3 hereto and products derived from them, who | || placed on the market for further processing in a Member State or region
unit, which are in accordance with § 38 or 39 recognized as being free of these diseases
can be temporarily stored at the place of processing if

A) originate from another Member State, zone or compartment
recognized as free to the disease, or

B) they are temporarily kept in dispatch, centers
cleaning or similar devices equipped with cleaning technologies or
wastewater, which destroys the originator to the disease, or
which reduces the risk of transmitting diseases to surface
waters to an acceptable level.

§ 14

Aquaculture animals and products derived from them, who
intended for human consumption and are placed on the market for human consumption without further
processing

(1) The provisions of § 13 shall not apply in cases where animals
aquaculture animals and species susceptible to one or more
diseases listed in Part II of Annex no. 3 hereto or || | products of which are placed on the market for human consumption without further processing
provided that they are packed in containers suitable for retail sale
that meet the requirements for packaging and labeling
set by European Union rules on specific health
rules for food of animal origin ^ 7).

(2) If, however, live molluscs and crustaceans that belong to species
susceptible to one or more of the diseases listed in Part II of Annex no. 3 to
this Decree temporarily relayed in Union waters, or introduced
into dispatch centers, purification centers or similar device
must meet the requirements of § 13 para. 2nd
Part 3


Wild and ornamental aquatic animals

§ 15

Drain wild aquatic animals in Member States, zones or compartments
recognized disease-free

(1) Wild aquatic animals of species susceptible to one or more
diseases listed in Part II of Annex no. 3 hereto
caught in a Member State, zone or compartment that is not in accordance with § 38
39 or recognized as free of the disease should be before draining into
farm or the mollusc farming area situated in a Member State
, zone or compartment that are recognized as free from relevant
disease, placed under state veterinary supervision to a quarantine facility in
suitable for long enough to make
risk of disease transmission reduce to an acceptable level.

(2) The State Veterinary Administration can give consent to the shallows
been applied traditional extensive aquaculture practice, without the quarantine
referred to in paragraph 1, provided that an assessment
risk and that the risk is not deemed greater than the risk

Associated with the procedure referred to in paragraph 1

§ 16

Putting ornamental aquatic animals on the market

Ornamental aquatic animals may be placed on the market if it does not
jeopardized the health status of aquatic animals from both
diseases listed in Part II of Annex no. 3 hereto and in terms of disease
Annex unlisted.
Section 4


Import of aquaculture animals and products derived thereof from third countries


§ 17

(1) Aquaculture animals and products derived from them
may only be imported from third countries or parts thereof that
appear on the list of third countries and parts of third countries drawn up and updated
Commission.

(2) The shipment of aquaculture animals and products thereof
acquired, imported under paragraph 1 shall be screened upon entering
Member States accompanied by a health certificate or other
accompanying document required by the regulations of the European Union which certifies
health of imported animals and the wholesomeness
imported products. This certificate must certify that the consignment meets the requirements
laid down by law, this Decree and European Union regulations on shipments
this kind, as well as the specific import conditions if they were
for each third country, parts thereof or group of third
countries established by the Commission.
TITLE III


Disease control measures AQUATIC ANIMALS
Part 1


Notification of aquatic diseases

§ 18

Persons pursuant to § 11 of the Act are required to immediately notify
regional veterinary administration of a suspect
dangerous infection or diseases transmitted from animals to humans, reported in accordance with this
obligations and to further regional veterinary administration investigation
symptoms suggesting a suspect dangerous infection involving
and increased mortality in aquaculture animals.
Part 2


Control measures
Section 1


Measures a suspected outbreak

§ 19

In cases of suspected occurrence of exotic diseases listed in Part II of Annex
no. 3 hereto, or in the case of suspected occurrence
non-exotic diseases listed in Part II of Annex no. 3 hereto in || | Czech Republic, zones or compartments with a health status
category I or III, part A of Annex no. 2 hereto, regional veterinary Administration


A) take samples for the purpose of testing the national reference laboratory or
reference laboratories for aquatic animal diseases
which meets the requirements specified in Annex no. 5 hereto,

B) prior to obtaining the sampling results referred to in subparagraph a)

First introduced in the respective farm or mollusc farming area where
is suspected outbreak, official surveillance

Second orders emergency health measures to control the disease, which
prevent the spread of disease to other aquatic animals, in particular measures to
without the consent of the regional health authorities could no animal
aquaculture leave the farm or mollusc farming area
where there is suspicion of outbreaks of disease, or to join them
,

Third initiate an epidemiological investigation under § 20.

§ 20
Epidemiological investigation


(1) The Regional Veterinary Administration continues the epidemiological investigation
if the examination of the samples in accordance with § 19 para. 1 point. a)
proves the presence of an exotic disease listed in Part II of Annex no. 3 to this Decree
in the Czech Republic, or the presence of non-exotic diseases listed in Part II
Annex no. 3 hereto in the Czech Republic, region
or compartments with a health status of either category I or III according to part A
Annex no. 2 to this Decree in relation to the disease.

(2) In particular, the epidemiological investigation

A) detect the possible origin of the disease and the source of contamination

B) verify whether

First aquaculture animals have left the farm or
mollusc farming area during the relevant period preceding
reporting suspected outbreaks of disease, in accordance with § 11 of the Act and § 18 par. 1

Second disease has not been introduced from other holdings.

(3) shows if the results of the epidemiological investigation that the disease could

Be introduced into one or more farms, farming areas
molluscs or surface water must be in these holdings
mollusc farming areas or surface waters taken measures referred to in §
19th case of large basin or coastal area, may
regional veterinary authority to limit the measures referred to in § 19
smaller area around the farm or mollusc farming area suspected of
disease if it considers that such area is large enough
to ensure that guarantee prevention of the spread of disease.

(4) If necessary, inform the State Veterinary Administration
competent authorities of neighboring Member States or third countries on suspicion of
outbreak.

(5) Regional Veterinary Administration initiated an epidemiological investigation also
if it has been informed pursuant to paragraph 4 of a suspect
infection in a neighboring Member State or third country.

§ 21


End action
The Regional Veterinary Administration terminates the measures referred to in § 19 para. 1 point.
B) and § 20 para. 1, if the examination of samples under § 19 para. 1 point. a)
prove the presence of disease.
Section 2


Minimum measures to control the disease in the confirmation of an outbreak of exotic disease


§ 22

In the confirmation of an exotic disease listed in Part II of Annex
no. 3 hereto for aquaculture animals
competent authority of the Veterinary Administration ordered emergency health measures,

A) officially declaring the farm or mollusc farming area
infected

B) shall establish around the farm or mollusc farming areas which were
declared infected restricted zone corresponding to the type and character
risk of the disease and its spread, which includes the protection zone and the surveillance zone
, | ||
C) order without the consent of the regional health authorities to avoid
restocking moving animals originating from aquaculture
into the restricted zone, within it, or that zone,

D) orders or take other measures necessary to ensure that it
prevent the spread of disease to other aquatic animals.

§ 23

(1) Aquaculture animals which have reached commercial
size and show no clinical signs of disease may be
under official veterinary supervision used for human consumption or for further processing
.

(2) Harvesting, introduction into dispatch centers or centers
cleaning, further processing and other activities related to the preparation of animals
aquaculture for their involvement in the food chain is carried out under conditions
which prevent the spread
responsible for causing the disease.

(3) dispatch centers, purification centers and similar facilities
must be fitted with cleaning technologies or disposal of waste water, which destroys
originator to the disease, or reduces the risk of transmission of infection
into surface waters acceptable level.

(4) Further processing of aquaculture animals, referred to in paragraph 1
is performed in authorized processing establishments.

§ 24

(1) Disposal of dead fish and crustaceans, as well as live fish or shellfish
showing clinical signs of disease is carried out in the shortest possible time
under official veterinary supervision and in accordance with European Union regulations
health rules concerning animal by-products
animal origin not intended for human consumption ^ 9), in
accordance with the contingency plan provided for in § 36.

(2) Aquaculture animals which have not reached commercial
size and do not show clinical signs of disease, shall be submitted within
reasonable, having regard to the type of production and the risk such animals pose for
more the spread of disease
disposed of in accordance with regulations of the European Union and the contingency plan referred to in paragraph 1


§ 25

(1) Where possible, infected farms or mollusc farming area
after the evacuation and cleaning and disinfection
allowed a reasonable period of time without stocking.

(2) If a farm or mollusc farming area keeping
aquaculture animals not susceptible to the relevant

Infection, it is possible to leave without their stocking dependent upon
risk assessment.

(3) The competent veterinary authorities shall take the necessary additional measures
to prevent the spread of disease to other aquatic animals.

(4) Leaving without stocking for the purposes of disease control means using
where a farm is emptied animals originating from aquaculture
who are sensitive to the respective disease, or on which
known that they can transmit the pathogen, and when the economy
removed, if possible, even the water in which such animals are bred
.

§ 26


End action
Competent authority of the Veterinary Administration terminates the measures referred to in § 22-25

A) after the measures provided for disease control

B) in the case of restricted zone, after sampling their
examination with negative results and the implementation of official control; provided that these activities were carried
, depending on the type of infection and
concerned aquaculture production business.
Section 3


Minimum disease control measures confirmation of a non-exotic disease


§ 27
General


(1) the confirmation of non-exotic diseases listed in Part II of Annex
no. 3 hereto for aquaculture animals in
Czech Republic, zone or compartment that are recognized as free
to the disease, the competent authority of the veterinary administration

A) the measures set out in § 22 to 26 with the aim of restoring the status
country, zone or compartment disease-free, or

B) establish a program for sanitation according to § 34 para. 3rd

(2) Notwithstanding § 24 para. 2, the regional veterinary authority if
was applied measures referred to in paragraph 1. a) give consent to
order to achieve clinically healthy animals before slaughter for human consumption
market size, or to be moved to another
infested areas or units. In these cases must be taken
measures to limit further spread of the disease and, if possible, prevent.

(3) In order to be restored status of the state, region or units of affordable
disease progresses according to § 28th

§ 28

Disease control measures

(1) the confirmation of non-exotic diseases listed in Part II of Annex
no. 3 hereto for aquaculture animals in
Czech Republic, zone or compartment that is not recognized as free
to the disease, the competent authority of the veterinary administration
emergency veterinary disease control measures.

(2) The measures referred to in paragraph 1 shall consist of at least

A) declaring the farm or mollusc farming area to be infected,

B) the demarcation of the restricted zone around the farm or mollusc farming area
which have been declared infected, which is reasonable and appropriate
infection includes the protection zone and the surveillance zone,

C) restricting the movement of aquaculture animals from a restricted zone
so that these animals can only be

First moved to a farm or mollusc farming area in accordance with the rules laid down
for movements of animals coming from
aquaculture, particularly their movements between Member States
zones and compartments with different health statuses in Part A of Annex
no. 2 hereto, or

Second harvested and slaughtered for human consumption in accordance with § 23 para. 1

D) the disposal of dead fish and crustaceans, under the supervision of the official
veterinarian and in accordance with European Union regulations on
health rules for animal by-products, which
not intended for human consumption ^ 9 ), and this within a reasonable period
with respect to the type of production and the risk such dead animals
pose for further spread of the disease.
Section 4


Minimum measures to control the disease in the confirmation of the outbreak
listed in Part II of Annex no. 3 hereto in wild aquatic animals


§ 29

(1) Where wild aquatic animals are infected
exotic disease listed in Part II of Annex no. 3 hereto, or if there
suspected of being infected by that disease, the competent veterinary authority | || administration

A) monitoring the health situation,


B) take orders and if necessary emergency health measures
limiting further spread of the disease and, if possible, prevent.

(2) Where wild aquatic animals in the Czech Republic
area or unit which are recognized as free of the disease, infected with non-exotic
diseases listed in Part II of Annex no. 3 hereto, or
suspected of being infected by a plague, the competent authority of the veterinary administration


A) monitoring the health situation,

B) take orders and if necessary emergency health measures
limiting further spread of the disease and, if possible, prevent.

§ 30

State Veterinary Administration informs the Standing Committee
Food Chain and Animal Health Commission and other Member States of the measures taken by
§ 29th
Section 5


Measures to combat emerging diseases

§ 31

(1) Where a disease emerging in the Czech Republic
jeopardize the health status of aquatic animals, the competent authority veterinary administration

A) monitoring the health situation,

B) take orders and if necessary emergency health measures
limiting further spread of the disease and, if possible, prevent.

(2) The State Veterinary Administration shall inform without delay the Member States
Commission and the Member States of the European Free Trade Association
about their findings if they are epidemiologically significant.
Section 6

Alternative measures


§ 32

If it was a decision of the Union institutions authorized for a limited period
and under conditions appropriate to the disease situation
implement specific measures established for a particular case, because
measures laid down by this Decree are not appropriate for your health situation or the
infection is spreading despite all the measures taken in accordance with § 19 to 33, the competent authority shall
veterinary authority in accordance with this decision
.

§ 33

(1) If an infection that is not listed in Part II of Annex no. 3 to this
Decree represents a significant risk for the animal health situation
aquaculture or wild animals in the Czech Republic
they can be made as needed and ordered appropriate measures
necessary for preventing the introduction of the disease or its damping.

(2) The State Veterinary Administration shall inform the Commission of measures taken pursuant to paragraph 1
if these measures may affect trade between Member States
; These measures are subject to approval by the European Union.
TITLE IV


Disease control programs A VACCINATION
Part 1


Programs for surveillance and sanitation and contingency plans

§ 34

Drawing up and approval of surveillance and sanitation programs

(1) Unless the Czech Republic infested with one or more non-exotic
diseases listed in Part II of Annex no. 3 hereto and unless
yet declared free of one or more of these diseases (Category | || III, part a of Annex no. 2 hereto), drawn up by the State veterinary Administration
surveillance program for achieving the status of state
disease-free for one or more of these diseases and submit them for approval
Commission.

(2) If, however, an oversight program to cover individual compartments or
areas, which represent more than 75% of the territory of the Czech Republic, and consists
If this area or unit of the basin, which is shared with
another Member State or third country, the procedure is in any
approval, amendment or termination of the program in accordance with § 39 par.
second

(3) If the Czech Republic infested (category V Part A of Annex
no. 2 hereto) one or more non-exotic diseases listed in Part II
Annex no. 3 hereto, shall draw the State veterinary Administration
proposal sanitation program for one or more of these diseases
which must be after the approval of the Ministry of agriculture
submitted to the Commission for approval.

(4) From the date of approval of the programs covered by this provision
requirements and measures according to § 8-16, 19-21 and 27 paragraph. 1 in relation to
country, zone or compartment recognized disease-free
also apply in relation to the State, zone or compartment covered by those programs.

(5) The provisions of paragraphs 1 and 3 of the Commission approving the programs
apply mutatis mutandis to the amendment or termination of the program.


(6) The State Veterinary Administration maintains and continuously updates a list of approved programs
surveillance and sanitation programs and publishes it on its website
.

§ 35

The content and duration of application programs

(1) The program of surveillance and sanitation program must contain in particular

A) a description of the health situation before the start of the program

B) an analysis of the estimated costs and the anticipated benefits of the program

C) the likely duration of the program,

D) a description and demarcation of the geographical and administrative area in which the program is to be implemented
,

E) the objective to be attained at the date of termination of the program.

(2) The programs referred to in paragraph 1 shall apply until

A) the requirements set out in Annex no. 4 hereto and
Czech Republic, zone or compartment not recognized as free of the disease, or


B) the program is terminated by the State Veterinary Administration, in case
sanitation program with the approval of the Ministry of Agriculture, or the Commission, because
longer fulfills its purpose.

(3) If the program is terminated pursuant to paragraph 2. b)
apply from the date of his termination measures to prevent the spread of the disease mentioned in §
28th

§ 36

Contingency plan for emerging and exotic diseases

(1) The State Veterinary Administration shall, in accordance with the criteria and
requirements specified in Annex no. 6 hereto
national contingency plan for emerging and exotic diseases that
down the necessary measures for maintaining a high level of awareness of these
disease awareness and preparedness in the event of their occurrence, as well as
ensure environmental protection.

(2) The contingency plan referred to in paragraph 1 shall meet the following requirements
:

A) determining the powers and resources that will enable health authorities
Administration access to all facilities, equipment, materials and personnel,
which is essential to the rapid and efficient eradication of the outbreak

B) ensure coordination and compatibility with neighboring
procedure Member States and promoting cooperation with neighboring third countries

C) giving precise data concerning the vaccine requirements and
vaccination conditions considered necessary in the event of emergency vaccination.

(3) Under the contingency plan referred to in paragraph 1 shall apply in
case of an emerging disease or exotic disease listed in Part II
Annex no. 3 hereto.
Part 2

Vaccination


§ 37

(1) Vaccination against exotic diseases listed in Part II of Annex no. 3 to
this Decree shall be prohibited except in cases where such vaccination
applied in accordance with § 31, 32 or 36. || |
(2) Vaccination against the non-exotic diseases listed in Part II of Annex no. 3
hereto is prohibited in all parts of the Czech Republic, which
are in accordance with § 38 and 39 are recognized as free from the relevant disease or on
covered by a surveillance program approved in accordance with § 34 para.
first vaccination can enable only those parts of the territory of the Czech Republic, which
not recognized as free to the disease, or in the case
that vaccination is part of the sanitation approved in accordance with § 34 para. 3rd

(3) The provisions of paragraphs 1 and 2 shall not apply to scientific studies that
used for developing and testing vaccines under controlled conditions
. During such studies, however, have user devices
accredited under the law to protect animals against cruelty
adopt appropriate measures to protect other aquatic animals from any adverse effects of
thus made vaccination.

(4) The use of vaccine must be registered by another
legal regulation 10).
TITLE V


DISEASE-FREE STATUS

§ 38

State free from disease

(1) The State Veterinary Administration may propose to the authorities of the Union to the Czech Republic
granted free status of one or more
non-exotic diseases listed in Part II of Annex no. 3 hereto, if
compliance with the requirement in paragraph 2

A) in the Czech Republic there are no species susceptible to the disease on
,

B) it is known that the agents of the disease is not in the Czech Republic and
its water resources to survive, or


C) The Czech Republic meets the requirements set out in Part I of Annex no. 4 to
hereto.

(2) Where neighboring Member States, or water catchment areas shared with neighboring
Member States are recognized as disease-free zones must be established in the Czech Republic
establish appropriate buffer zones designed to protect the Czech Republic from the disease
from passive introduction to the disease.

§ 39

Zone or free of the disease

(1) zone or the Czech Republic can be recognized as
simple one or more non-exotic diseases listed in Part II of Annex
no. 3 hereto, if

A) the zone or compartment, or in its water source is
There are no species susceptible to that disease

B) it is known that the agents of the disease can in
or unit, or in a water source to survive, or

C) the zone or compartment comply with the requirements set out in Part II of Annex
no. 4 hereto.

(2) The State Veterinary Administration submitted to the Standing Committee on the Food
Chain and Animal Health statement of recognition pursuant to paragraph 1, together with supporting evidence
manner prescribed by the Commission.

(3) If a zone or compartment as referred to in paragraph 1
represent more than 75% of the territory of the Czech Republic, or consists of, the zone or
unit of the river basin shared by another Member State or third country || | does not proceed in accordance with paragraph 2 and the possible recognition of areas or units
disease-free opt Union institutions.

§ 40

State Veterinary Administration maintains and continuously updates a list of areas and units
declared in accordance with § 39 par. 2 disease-free and
publish it in a manner allowing remote access via the Internet
.

§ 41

Maintaining disease-free status

(1) If the Czech Republic recognized in accordance with § 38
simple one or more non-exotic diseases listed in Part II of Annex no. 3 to this decree
can be terminated surveillance program and maintain status State
disease-free if there are conditions that promote
relevant clinical manifestations of the disease, and if they are applied
relevant provisions of this Decree.

(2) Unless the Czech Republic recognized as free from the disease must
areas and units, which are recognized as free of the disease, and in all cases where there is no
conditions that promote clinical | || symptoms to the disease, continuing surveillance in accordance with the methods set out
Union institutions, but at a reasonable level of risk.

§ 42

Suspension, restoration and withdrawal of the status of the state, zone or compartment disease-free


(1) If it can be reasonably assumed that it violated any of the conditions for maintaining the status
country, zone or compartment disease-free, the State Veterinary Administration


A) immediately suspend the marketing of susceptible species and species that are
carriers on the market in other Member States, zones or compartments with
higher health status in relation to the respective disease in accordance with Part A
Annex no. 2 hereto,

B) proceed in accordance with § 19 to 21, 27 and 28

(2) If the epidemiological investigation pursuant to § 20 para. 1

A) establishes that a violation of the conditions for maintaining the status of the state, region or units of affordable
infection occurred, the status of the state, region or
disease-free unit resumes

B) confirm a high probability that the infection occurred, status
country, zone or compartment disease-free should be removed
same procedure under which that status was recognized. Before restoring this
status must meet the requirements specified in Annex no. 4 to this Decree
.
TITLE VI


Veterinary administration bodies COOPERATION WITH OTHER INSTITUTIONS, LABORATORIES AND DIAGNOSTIC METHODS


§ 43

State Veterinary Administration provides effective and lasting cooperation between
veterinary authorities and between these authorities and laboratories
for aquatic animal diseases, as well as mutual exchange of information and access
of the Veterinary Administration to the latest developments in
areas of risk analysis and epidemiology.

§ 44

National Reference Laboratory

(1) The National Reference Laboratory for aquatic animal diseases
material and personnel resources to perform laboratory tests
under this Decree,


A) carries out the activities listed in Part I of Annex no. 5 hereto,

B) be responsible for coordination of diagnostic standards and methods used in the diagnosis
aquatic animal diseases

C) cooperate with the EU reference laboratory for aquatic animals
as laboratories referred to in § 45.

(2) The State Veterinary Administration informs the Commission, other Member States and
Union Reference Laboratory for aquatic animal diseases of the name and address
national reference laboratories referred to in paragraph 1 and
any changes.

§ 45

Other laboratories that were the State Veterinary Administration
intended for laboratory testing for the purposes of this Decree,

A) perform the activities listed in Part II of Annex no. 5 hereto,

B) used in laboratory tests in cases of suspected
occurrence or confirmation of an aquatic animal disease diagnostic
standards and methods laid down by the Union institutions.
TITLE VII


COMMON AND FINAL PROVISIONS

§ 46

(1) Where the Commission implements its experts checks, including on-site audits in
Czech Republic in order to ensure uniform application of the
European Union legislation relating to aquatic animals, providing them
State Veterinary Administration all necessary assistance to fulfill their obligations
. More detailed procedural rules within the framework of this collaboration are set
EU legislation on official controls and their organization
^ 11).

(2) If the inspection pursuant to paragraph 1 of serious health risk
aquatic animals makes veterinary authorities immediately in accordance with the law and
this decree all measures necessary to protect the health of these animals
.

§ 47

Repealed:

First Decree no. 381/2003 Coll., On animal health requirements for
aquaculture, fishery products and live bivalve molluscs and
veterinary conditions for their import from third countries.

Second Decree no. 201/2004 Coll., Amending Decree no. 202/2003 Coll., On
veterinary requirements for fresh meat, minced meat, meat preparations and meat products
, as amended by Decree no. 375 / 2003 Coll., and Decree no.
381/2003 Coll., on veterinary requirements for animals coming from
aquaculture and aquatic products, fishery products and live bivalve molluscs and
veterinary conditions for their import from third countries, in
amended by Decree no. 289/2007 Coll.
PART TWO



EFFICIENCY
§ 48

This Decree shall take effect on the fifteenth day following its publication.
Minister
:

Mgr. Gandalovič vr
Appendix 1


Particulars to be entered in the list of approved production enterprises
aquaculture and authorized processing establishments

I. Data on approved aquaculture production business

First The competent authority of the Veterinary Administration stated in the list under § 5 of this ordinance
at least the following information on each aquaculture production business
:

) The name and address of the aquaculture production business, and contact details
(phone, fax, e-mail);

B) veterinary approval number and other information relating to the approval
aquaculture production business (ie. The date of approval
identification numbers, the specific conditions of production, etc.).

C) the geographical position of the farm defined by a suitable system of coordinates of all farm
(if possible, geographic coordinates of
Information System - GIS);

D) the purpose, type (ie. The type of culture system, or facilities such as
ground facilities, sea cages, earth ponds) and maximum volume of production,
if it is regulated;

E) for continental farms, dispatch centers and purification centers
data on water resources and water discharge;

F) the species of aquaculture animals reared at the farm
(in case the economy behaved more species or farm
behaving animals for ornamental purposes must be stated whether it is a
any of the species known to be receptive to any of the diseases listed in part II of Annex
no. 3 hereto, or whether it is known that the carrier
);

G) updated information on the health status (ie. Whether the economy
free of the disease in relation to the State, zone or compartment that is
farm is under a program aimed at achieving such status,

Or whether the farm is declared infected by a disease referred to in Annex
no. 3 hereto).

Second If approved mollusc farming area in accordance with the Act and § 3
paragraph. 2 of this Decree, shall be recorded data required under point 1.
A) for all aquaculture production businesses which operate inside the mollusc breeding
area. The data required under point 1. b) to g)
recorded at mollusc farming area level.

II. Data on the authorized processing establishment

Competent authority of the Veterinary Administration stated in the list under § 5 of this ordinance
least the following information on each authorized processing establishment
:

) The name and address of the authorized processing establishment, and contact
information (phone, fax, e-mail);

B) veterinary approval number and other information relating to the approval
authorized processing equipment (ie. The date of approval
identification number, the specific conditions of production, etc.).

C) the geographical position of the authorized processing establishment defined
suitable system of coordinates (if possible, geographic coordinates of
Information System - GIS);

D) details about the technologies or cleaning wastewater
authorized processing equipment;

E) type (s) of aquaculture animals which are
authorized processing facilities processed.
Appendix 2


A. The health status of aquaculture zones or compartments to which it is necessary
taken into account in the application of § 7 of this Decree

Aquaculture animals for breeding and restocking
--------------------------------------------------------------------------------------------------------
Categories of health status of animals veterinary certificate animals
They may be
admitted -------------------- sent to
dispatch acceptance
--------------------------------------------------------------------------------------------------------
I region free of the disease only category yes, if all categories
(§ 38 or 39 that I
terms of the decree) to send
category
III or V
So, if
regards
sending to
category
I, II or
IV
--------------------------------------------------------------------------------------------------------
II surveillance program (§ 34 only category yes Category III and V
paragraph. 1 hereto) I
--------------------------------------------------------------------------------------------------------
III undefined (area of ​​category I, II, no no Category III and V
is not contaminated, but or III

not included in the program to obtain free status

disease
--------------------------------------------------------------------------------------------------------
IV sanitation program (§ only category yes yes categories in paragraph 34
.
I 3 of this Decree)
--------------------------------------------------------------------------------------------------------
The infested area (§ 28 of all no yes Category V
paragraph. 2 of the Decree) categories
--------------------------------------------------------------------------------------------------------

B. Recommended surveillance and recommended frequency of checks on farms and mollusc farming areas

------------------------------------------------------------------------------------------------------------------------
Present health status of the recommended level of oversight recommendations for specific kinds of remarks
risk under Part A of the frequency of the frequency requirements
*) health official controls of control, taking
Water samples and controls health surveillance
animals (§ 6 para. 2 of water necessary to
**) the animals maintain the
Decree) (§ 6 para. 1 of this Decree
health) status

------------------------------------------------------------------------------------------------------------------------
Any kind of category I Low Passive 1 every 4 years 1 every 4 years specific recommended frequency
receptive to the area recognized requirements for checks applies
infection for the simple preservation without prejudice
mentioned in the infections status area specific requirements
Annex no. 3 accordance with § 38 disease-free zones set out for each
this paragraph. 1 point. according to § 41 of the health status;
Decree a) or b), or decree, where possible, should
§ 39 par. 1 should be checks and
point. a) or sampling Combined
b) this bath with controls
Decree pursuant to § 6 of this
Decree; goal
official controls by
§ 6 para. 2 of this
Decree is to verify
compliance with this
by decree; goal
checks the health of aquatic
animal
It is to check the health
-------------------------------------------- ----------------------------------------------- status of animals,
kind of category I high active 1 year 1 year to provide advice
susceptible to targeted area recognized operators for
one or businesses
duction or more infections from the disease passive aquaculture issues listed vv
accordance with § health-related
Annex no. 3 38 par. 1 of aquatic animals,
to this point. c) or § if necessary, adopt
Decree 39 required veterinary
paragraph. 1 point. measures
c) the
Decree
Medium 1 every 2 years 1 every 2 years

Low 1 every 4 years 1 every 2 years

-----------------------------------------------------------------------------------------------------------
Category II High Targeted 1 every year 1 every year specific
Unrecognized area requirements by
for the simple § 34 para. 1
infection, but this decree
subject
surveillance program
according to § 34
Sec. 1 of this
Decree
Medium 1 every 2 years 1 every 2 years

Low 1 every 4 years 1 every 2 years

------------------------------------------------------------------------------------------------------------------------
Category III high active 1 year 3 year
area that
not contaminated and
not subject
surveillance program
in order
status
region free
infection


Central 1 year 2 year

Low 1 every 2 years 1 year

------------------------------------------------------------------------------------------------------------------------
Category IV High Targeted 1 every year 1 every year specific
infested area requirements by
subject to § 34 par. 3
Program ozdra this decree
ment of according to §
34 paragraph. 3 of this
Decree
Medium 1 every 2 years 1 every 2 years

Low 1 every 4 years 1 every 2 years

------------------------------------------------------------------------------------------------------------------------
In the high category Passive 1 every 4 years 1 every year specific
infested area requirements by
subject to Title III
minimum Decree
control
actions by
Title III
Decree
Medium 1 every 4 years 1 every 2 years

Low 1 every 4 years 1 every 4 years
------------------------------------------------------------------------------------------------------------------------

Table explanations:

*) Farm or mollusc farming area with


Is a high-risk farm or mollusc farming area

A) who are at high risk of the spread or introduction of disease to other
or from other farms or wildlife populations;


B) which operate in such breeding conditions, which could
with respect to the species present increase the risk of an outbreak (
large amounts of biomass, low water quality);

C) sells live aquatic animals for further farming or restocking
states.

Farm or mollusc farming area with


Is a medium-risk farm or mollusc farming area

A) where a medium risk of spreading or disease incursions into
other or from other farms or wildlife populations;

B) which operate in such breeding conditions, which, having regard to the species present
not necessarily increase the risk of an outbreak
(medium biomass, secondary water quality);

C) sells live aquatic animals mainly for human consumption.

Farm or mollusc farming area with


Is a low-risk farm or mollusc farming area

A) which have a low risk of spreading or disease incursions into other
or from other farms or wildlife populations;

B) which operate in such breeding conditions, which, having regard to the species present
not increase the risk of an outbreak (
low biomass, good water quality);

C) sells live aquatic animals for human consumption.
**
) Passive surveillance includes mandatory immediate notification of the occurrence of specified
disease or suspicion of their occurrence or increased mortality.
In this case requires investigation in accordance with Title III, part 2, Section 1
hereof.
Active surveillance involves
:

A) routine inspection by the competent authority or by other qualified health services
authorized by the competent authorities;

B) inspection of the population of aquaculture in
farm or mollusc farming area for the clinical disease;

C) collection of diagnostic samples during the inspection in case of a suspected outbreak
listed or observed increased mortality;

D) mandatory immediate notification of the occurrence of specified diseases or suspected
their occurrence or any of increased mortality.

Targeted surveillance includes:

A) routine inspection by the competent authority or by other qualified health services
authorized by the competent authorities;

B) taking prescribed samples of aquaculture animals and their
testing for the pathogen-specific (
specific pathogens) by specified methods;

C) mandatory immediate notification of the occurrence of specified diseases or suspected
their occurrence or any of increased mortality.
Appendix 3


Criteria for inclusion on the list of diseases, the list of diseases

I. Criteria for inclusion on the list of disease

A. Exotic diseases shall meet the criteria set out in paragraph 1 and paragraph 2 or 3.


First Infection is exotic, if not occur in aquaculture Union and its
pathogen is not known to be present in Union waters.

Second If introduced into the Union, this disease could have a significant economic impact
either by production losses in aquaculture Union
or restricting the potential for trade in animals originating from
aquaculture products and products derived therefrom.

Third If introduced into the Union, this disease could have a devastating effect on
environment that affects populations of wild aquatic
animals belonging to species that constitute the wealth that you
deserve to be protected by European Union law
or international regulations.

B. Non-exotic diseases shall meet the criteria set out in paragraphs 1, 4, 5, 6
7 and paragraph 2 or 3.

First Several Member States or regions in several Member States
free of the disease.

Second If introduced into a Member State free of the disease would
this disease could have a significant economic impact
either by production losses, and annual costs associated with the infection and its damping
exceed 5% of the value of production of the susceptible species originating
aquaculture in the region, or by restricting the potential
international trade in aquaculture animals and products derived from them
.

Third If the disease has been introduced into a Member State free of the disease, a devastating

Impact on the environment, which affects the population of wild
aquatic animals belonging to species that represent wealth
which deserve to be protected by European Union law or international regulations
.

Fourth At the level of the farm or mollusc farming area can only
infection difficult to control and prevent it from spreading without stringent measures
for disease control without trade restrictions.

Fifth Plague can be effectively dampen at Member State level, as is the experience
known that it is possible to create and maintain a zone or compartment
free of the disease, and that this maintenance is cost-effective in terms
.

6th There is a risk that when placing animals coming from
aquaculture products appear infection in previously uninfected area.

7th They are reliable and simple tests for investigation
infected aquatic animals. The tests must be specific and sensitive and
testing method must be harmonized at EU level.

II. The list of diseases
II. List of diseases
--------------------------------------------------------------------------------------------------------
1) an exotic disease
--------------------------------------------------------------------------------------------------------
DISEASES VNÍMAVÉDRUHY
--------------------------------------------------------------------------------------------------------
FISH Epizootic haematopoietic necrosis Rainbow trout (Oncorhynchus mykiss

) and perch
perch (Perca fluviatilis

)
--------------------------------------------------------------------------------------------------------
MOLLUSCS bonamiosis (Bonamia exitiosa

), oyster (Ostrea Angas


and Ostrea chilensis
)

perkinsóza (

Perkinsus marinus)

Crassostrea gigas Crassostrea virginica and



MIKROCYTOSIS (Mikrocytos mackini

)
Crassostrea gigas, Crassostrea virginica,
Ostrea conchaphila
Ostrea edulis and


--------------------------------------------------------------------------------------------------------
CRUSTACEANS Taura Syndrome shrimp (Penaeus
setiferus, Penaeus stylirostris

and

Penaeus vannamei)

Yellowhead (

Yellowhead disease), shrimp (Penaeus
aztecus, Penaeus duorarum,
Penaeus japonicus, Penaeus monodon, Penaeus
setiferus, Penaeus stylirostris and


Penaeus
vannamei)
--------------------------------------------------------------------------------------------------------
2) non-exotic diseases
--------------------------------------------------------------------------------------------------------
DISEASES VNÍMAVÉdruhy
--------------------------------------------------------------------------------------------------------
FISH viral haemorrhagic septicemia (VHS) Herring (Clupea spp
.
), Whitefish (Coregonus sp
.
), Pike
General (Esox lucius

), haddock (Gadus


aeglefinus), cod (Gadus macrocephalus

)
Atlantic cod (Gadus morhua

), Oncorhynchus

spp.
, Rainbow trout (Oncorhynchus mykiss

)
cod squid (Onosmustelus

), trout
(

Salmo trutta), turbot (Scophthalmus


maximus), sprat (Sprattus sprattus

), grayling
grayling (Thymallus thymallus

) and flounder species


Paralichthys olivaceus

Infectious haematopoietic necrosis (IHN), Salmon (Oncorhynchus keta

), coho salmon
(

Oncorhynchus kisutch) salmon meat
(

Oncorhynchus masou), rainbow trout or
Migrant (

rainbow trout), sockeye salmon
(Oncorhynchus nerka

), Pacific salmon rodurus
(Oncorhynchus rhodurus

), chinook salmon
(Oncorhynchus tshawytscha

) and salmon
(Salmo salar

)


Koi herpes virus (KHV), common carp and koi carp (Cyprinus carpio

)

Infectious salmon anemia (ISA) rainbow trout (Oncorhynchus mykiss

), salmon
Infection family Isavirus (ISAV) genotype general (

Salmo salar) and brown trout (Salmo

HPR with deletion trutta
)
--------------------------------------------------------------------------------------------------------
Mollusk marteiliosis (Marteilia refringens

)
Ostrea Angas, Ostrea chilensis, Ostrea
edulis, Ostrea puelchana
, mussel
(

Mytilus edulis) and Mediterranean mussel
(Mytilus galloprovincialis

)

bonamiosis (Bonamia ostreae

)
Ostrea Angas, Ostrea chilensis, Ostrea
conchaphila, Ostrea denselammellosa
oysters
edible (

Ostrea edulis) and Ostrea puelchana


--------------------------------------------------------------------------------------------------------
CRUSTACEANS White spot disease (

White spot disease) all desetinozí crustaceans (order Decapoda

)
--------------------------------------------------------------------------------------------------------
Appendix 4


Requirements for publication of a Member State, zone or compartment affordable infection


I. Disease-free Member State

First Based on previous developments:

01.01 Member State in which there are susceptible species, but which has not been
for at least 10 years before the date of application of free status
infection reported incidence of infection despite conditions that are conducive to its
clinical expression may be considered free disease if:

A) are carried out continuously for at least 10 years before applying
disease-free status basic measures for ensuring biosafety
;

B) infection was detected in wild populations;

C) are being effectively applied trade and import conditions that prevent
introduction of the disease into the Member State.

A Member State wishing to benefit from the status
State that is free of disease, must submit an application within the meaning of § 38 of this Decree
1 November, 2008. After that date, be granted the status of a disease free state only
in accordance with point 2

02.01 The basic measures for biosecurity are
under Section 1.1. point. a) at least:

A) the existence of the obligation to declare outbreaks of disease, the competent authority
including reporting suspected outbreaks of disease;

B) functioning of an early detection system enabling the competent authority
perform throughout the state effective disease investigation and reporting, ensuring in particular
:

- Early detection of clinical signs consistent with the suspicion of
outbreak of the disease, early detection of emerging diseases or
unexplained mortality in farms, mollusc farming areas and
in the wild

- Rapid reporting of events to the competent authority for the purpose of possible
fastest launch diagnostic investigation.

03.01 Early detection system in accordance with paragraph 1.2. point. b) must include at least
:

A) broad awareness among the personnel employed in aquaculture enterprises
or in the processing of aquaculture animals, if
regarding any symptoms related to the outbreak, and professional
veterinarians or aquatic health experts
animals aimed at recognizing and reporting unusual occurrence
disease;

B) veterinarians or experts on aquatic animal health
trained in recognizing and reporting suspected outbreaks of disease;

C) access by the competent authority to laboratories with the facilities for diagnosing and
differential diagnosis of diseases mentioned in the list of diseases, as well as newly emerging diseases
.

Second Based on targeted surveillance:

Member State where the last known clinical occurrence of the disease in
during the 10 years prior to disease-free status, or in
which was unknown infection status prior to targeted surveillance
example because of the absence of conditions
conducive to clinical expression of the disease, may be considered free from a specific disease if:

A) the Member State implements basic disease control measures laid down

In section 1.2. and

B) targeted surveillance in accordance with methods adopted by the Union institutions
took place over a period of at least two years, without being in any farm or farming area
shellfish behaving any susceptible species found
pathogenic agent.

If there are parts of the Member State in which a limited number
farms or mollusc farming areas and which therefore targeted surveillance
does not provide sufficient epidemiological data, but in which there
wild populations of susceptible species these must be free-living population
included in the targeted surveillance.

II. Zones or compartments free of the disease

First Areas:

01.01 The area may consist

A) of the whole catchment area from the source to the estuary, or

B) of the basin from the source (s) to a natural or artificial
barrier that prevents the migration of aquatic animals from lower stretches
basin upstream or

C) more than one catchment area, including their estuaries, in
due to the epidemiological link between the catchment areas through the estuary
.

Geographically defined areas must be clearly marked on the map.

02.01 If the area exceeds the territory of one Member State may be
declared free from the disease only if vztahují-
conditions set out in paragraphs 3.1, 1.4 and 1.5 to any part of that area
. In this case, all the Member States concerned shall apply for approval
that part of the field, which is located on their territory.

03.01 The area in which there are susceptible species, but which has not been
for at least 10 years prior to disease-free status
reported incidence of infection despite conditions that are conducive to its clinical
expression, may be considered free from the disease,
if it meets reasonable requirements set out in part I. 1.

02.01 A Member State wishing to enjoy the benefits of free status
disease must declare the intention within the meaning of § 39 par. 2 of this Order to
first November 2008. After this date, you are granted free status
disease only in accordance with section 1.2.

04.01 The area where the last known clinical occurrence of the disease in
during the 10 years prior to disease-free status, or in
which was unknown infection status prior to targeted surveillance
example because of the absence of conditions conducive to clinical expression of the disease ,
can be considered free of the disease if adequately meets
requirements set out in part I. 2.

05.01 If appropriate, it must be a buffer zone for
execution monitoring program. The buffer zone must be defined
so that the area protected from the disease from passive introduction of the disease
.

Second Unit consisting of one or more farms or mollusc farming
areas where the health status regarding a specific disease
depends on the health status of surrounding surface waters:

02.01 The unit may consist of one or more farms,
groups or clusters of farms, or a mollusc farming area that
can be considered as one epidemiological unit due to
geographic location and distance from other groups or clusters || | farms or mollusc farming areas, if all farms comprising the compartment fall
common biosecurity system.
Geographical demarcation units must be clearly marked on the map.

2.2 unit in which there are susceptible species, but which has not been
for at least 10 years prior to the application status of the unit free of the disease
reported incidence of infection despite conditions that are conducive to its
clinical expression, may be considered free from the disease if
adequately meets the requirements set out in part I. 1.

A Member State wishing to benefit from this provision must notify their intention
within the meaning of § 39 par. 2 of this Order to
November 1, 2008. After this date can be given the status of the unit free of the disease only
in accordance with Part I. 2.

03.02 The unit in which the last known clinical occurrence of the disease in
during the 10 years prior to the application status of the unit free of the disease, or in which
or in the waters around it was unknown infection status prior to targeted surveillance
example because
absence of conditions conducive to clinical expression of the disease, may be considered

From the disease, if it meets reasonable requirements set out in Part I.
second

04.02 If it is deemed necessary to prevent the introduction of diseases,
, any farm or any mollusc farming area in the unit
subject to additional measures imposed by the competent authority.
Such measures may include the establishment of a buffer zone in which it is carried
monitoring program around the unit, as well as additional measures
protection against the introduction of possible carriers or vectors of pathogenic agents
.

Third Unit consisting of one or more individual farms,
where the health status independent of the health status of surrounding surface water
:

03.01 The unit may consist

A) an individual farm which can be considered as a single epidemiological unit
because it is not influenced by the animal health status in the surrounding waters
or

B) more than one farm where each farm in a compartment
meets the criteria in subparagraph a) and points 2.3 to 03.06, while
due to extensive transfer of animals between farms
must be all farms considered as a single epidemiological unit
provided that all farms are subject
common biosecurity system.

03.02 The unit must be supplied with water

A) through a water treatment plant inactivating the relevant pathogen
order to reduce the risk of introducing disease to an acceptable level, or

B) directly from a well, borehole or a spring. If such water supply is situated outside
land management, water must be supplied directly to
farm, and be channeled through a pipe.

03.03 Aquatic animals from the surrounding watercourses into the
must defend natural or artificial obstacles.

04.03 If necessary, the unit must be protected against flooding and
infiltration of water from the surrounding watercourses.

05.03 The unit must adequately satisfy the requirements set out in Part I.
second

06.03 If it is deemed necessary to prevent the introduction of diseases,
unit must be subject to additional measures imposed by the competent authority
including additional measures to protect against the introduction of any
carriers or carriers of pathogens.

07.03 Implementing measures to item 3.2. point. a) establish the institutions of the Union.

Fourth Special provisions for individual farms
initiated on or restorative activities:

04.01 A new farm which meets the requirements set out in 3.1.
Point. a) and points 3.2 up to 3.6, but which commences its activities with
aquaculture animals supplied from the unit
considered free from the disease, may be declared disease-free without
undergoing the sampling required for approval.

04.02 An economy that restores activity after a break with animals
aquaculture supplied the units deemed to be a simple
disease and which meets the requirements set out in 3.1. point. a)
points and 3.2 to 3.6., may be declared disease-free without
undergoing the sampling required for approval if

A) the competent authority are known health records
economy for the last four years of its operation; if it was, however, concerned the economy
in operation for less than four years, taking into account the actual period
which has been in operation;

B) the economy is not covered by veterinary measures in relation to
diseases listed in Part II of Annex no. 3 hereto and in this economy
have been no antecedents of those
diseases;

C) the pre- aquaculture animals, eggs or gametes
to farm was cleaned and disinfected, then it
economy if necessary, left for some time without
stocking.
Appendix 5


Activities laboratories according to § 44 and 45 of the Decree

I. National Reference Laboratory

First The national reference laboratory designated under the Act and § 44 of this Decree
responsible for coordinating diagnostic standards and methods
its scope in the Czech Republic. The national reference laboratory
:

A) immediately notify the competent authority as soon as he learns about the suspected
occurrence of any disease mentioned in Annex no. 3 hereto;


B) coordinate, consistent with the European Union Reference Laboratory
methods used in the Czech Republic for the diagnosis of the diseases that fall
within its scope;

C) assist actively in the diagnosis of disease outbreaks relevant
receiving pathogen isolates for confirmation of diagnosis, characterization and epidemiological studies
;

D) supports basic training and retraining of experts in laboratory diagnosis
order to harmonize procedures and diagnostic methods in the Czech Republic
;

E) ensure confirmation of positive results of all outbreaks of exotic
diseases listed in Part II of Annex no. 3 hereto and
primary outbreaks of non-exotic diseases listed in that Annex;

F) organizing interlaboratory comparison tests (ring tests)
diagnostic procedures at national level with the laboratories to
designated in accordance with the Act and § 45 of this Decree in order to provide
information on the methods of diagnosis used and
results of tests carried out in the Czech Republic;

G) cooperate with the EU reference laboratory for aquatic animals
and participate in the comparative tests required by reference laboratories
Union;

H) ensure a regular and open dialogue with the competent national authorities
;

I) works is assessed and accredited in accordance with the following
European standards taking into account criteria for different testing methods
specified in this decree:

- EN ISO / IEC 17025 "General requirements for the competence of testing and calibration laboratories
"

- EN 45002 "General criteria for the assessment of testing laboratories"

- EN 45003 "The accreditation of calibration and testing laboratories
-General requirements for operation and recognition".

Second accreditation and assessment of testing laboratories in accordance with point 1. I) the
may relate to individual tests or groups of tests.

third State veterinary Administration approval may be given a national reference laboratory
to one or more of the diseases that fall within its scope
, used expertise and capacity of other laboratories designated
listed in § 45 of this Decree, provided, however, that
these laboratories comply with the relevant requirements of this part.
the national reference laboratory shall remain the contact point for the Czech Republic
Union reference laboratory .

II. the designated laboratories in the Czech Republic

first laboratory designated by the State veterinary administration for diagnostic services
specified in § 45 of this Decree:

a) inform without delay the competent authority shall, as soon as he learns about the suspected
occurrence of any disease mentioned in Annex no. 3 hereto;

B) participation in interlaboratory comparison tests (ring tests)
diagnostic procedures arranged by the national reference laboratory;

C) work are assessed and accredited in accordance with the following
European standards taking into account criteria for different testing methods
set this decree:

- EN ISO / IEC 17025 "General requirements for the competence of testing and calibration laboratories
"

- EN 45002 "General criteria for the assessment of testing laboratories"

- EN 45003 "The accreditation of calibration and testing laboratories -
General requirements for operation and recognition".

Second accreditation and assessment of testing laboratories in accordance with point 1. C) the
may relate to individual tests or groups of tests.

third State veterinary Administration cancels the designation of a laboratory, if you already
not fulfilled the conditions set out in part II. Appendix 6



criteria and requirements for contingency plans

contingency plans must:

first identify the competencies necessary for the rapid and successful implementation
contingency plans and eradication campaign;

second secure access to emergency funds, budgetary means and financial resources
to take into account all aspects of the fight against
exotic diseases listed in part II of Annex no. 3 of this Decree;

3rd define the vertical management structure to ensure
rapid and effective decision-making process against exotic diseases listed in Annex
no. 3 hereto or emerging diseases;
Strategic management of disease control must be the task of the central decision-making
instance;

Fourth to ensure the development of detailed plans, under which it will be possible in

Event of an outbreak of exotic diseases listed in Part II of Annex
no. 3 hereto or emerging diseases
promptly establish local disease control centers for the implementation of measures to control the disease
and environmental protection at the local level;

Fifth establish rules for cooperation between the competent authorities and competent
environmental authorities for the purpose of proper coordination
veterinary disease control measures with measures to protect
environment;

6th create conditions to ensure rapid and effective campaign to
fighting infections, including ensuring adequate laboratory capacity
personnel and equipment;

7th ensure that the available current working
guide with a detailed, comprehensive and practical description of all activities, procedures, guidelines and
specific measures applied during the outbreak of exotic
diseases listed in Part II of Annex no. 3 hereto
or newly emerging diseases, or even detailed plans for emergency vaccination;

8th require regular training of personnel issues
clinical symptoms, epidemiological investigations and disease control, training alarms
carried out in real time, training in communication skills in order
permanent readiness of the authorities, farmers and veterinarians to conquer disease
;

9th Remember to create the conditions to ensure the resources needed to combat
large number of outbreaks that occur in the short term;

10th ensure that in the event of an outbreak were dead bodies
aquatic animals and aquatic animal waste is disposed of summarily in
using techniques and methods that do not endanger human and animal health and the environment
particular procedures and methods | ||
- With minimal risk to soil, air, surface and groundwater
plants and animals

- With minimum disruption through noise or odors,

- With minimum adverse effects on the nature or places of special interest
. This does not affect the requirements laid down by European Union rules on
health rules for animal by-products, which
not intended for human consumption ^ 9);

11th contain information on suitable sites and processing facilities or
disposal of carcasses of aquatic animals and waste water
animals in accordance with Regulation of the European Parliament and Council Regulation (EC) no. 1774/2002
fixing hygiene rules covering animal by
animal by-products not intended for human consumption, in the event of an outbreak
.

1) Council Directive 2006/88 / EC of 24 October 2006 on animal health
requirements for aquaculture animals and products
aquaculture on the prevention and control of certain diseases in aquatic animals.

Commission Directive 2008/53 / EC of 30 April 2008 amending Annex IV
Council Directive 2006/88 / EC as regards Spring viraemia of carp
(SVC).

Implementing Commission Directive 2012/31 / EU of 25 October 2012, which
amending Annex IV to Council Directive 2006/88 / EC as regards the list of species
susceptible to viral hemorrhagic septicemia and removal items related
EUS.

Implementing Commission Directive 2014/22 / EU of 13 February 2014, which
amending Annex IV to Council Directive 2006/88 / EC as regards infectious
salmon anemia (ISA).

2) Regulation of the European Parliament and Council Regulation (EC) no. 1774/2002 of 3 October 2002
health rules concerning animal by-products
not intended for human consumption, as amended.

Regulation of the European Parliament and Council Regulation (EC) no. 852/2004 of 29 April 2004
food hygiene.

Regulation of the European Parliament and Council Regulation (EC) no. 853/2004 of 29 April
2004 laying down specific hygiene rules for food of animal origin
, as amended.

Regulation of the European Parliament and Council Regulation (EC) no. 854/2004 of 29 April
2004 laying down specific rules for the organization of official controls
products of animal origin intended for human consumption, in
as amended.

Regulation of the European Parliament and Council Regulation (EC) no. 882/2004 of 29 April
2004 on official controls to ensure verification of compliance with laws and regulations
with feed and food law, animal health and || | animal welfare.


3) For example, Act no. 114/1992 Coll., On Nature and Landscape
amended, Act no. 100/2004 Coll., On the protection of species of wild
wild fauna and flora plant regulating trade
them and other measures to protect these species and amending certain
laws (Act on trade in Endangered species), as amended by Act no. 444/2005 Coll
.

4) Article. 4 Regulation of the European Parliament and Council Regulation (EC) no. 853/2004, as amended in
.

5) Art. 2 and 3 of the European Parliament and Council Regulation (EC) no. 178/2002
laying down the general principles and requirements of food law,
establishing the European Food Safety Authority and laying down procedures
matters of food safety , as amended.

Art. 2 Regulation of the European Parliament and Council Regulation (EC) no. 852/2004.

Art. 2 Regulation of the European Parliament and Council Regulation (EC) no. 853/2004, as amended
.

Art. 2 Regulation of the European Parliament and Council Regulation (EC) no. 882/2004, as amended
.

6) European Parliament and Council Regulation (EC) no. 854/2004, as amended
.

Regulation of the European Parliament and Council Regulation (EC) no. 882/2004.

7) European Parliament and Council Regulation (EC) no. 853/2004, as amended
.

8) Decree no. 299/2003 Coll., On measures for prevention and eradication
infections and diseases transmissible from animals to humans, as amended
regulations.

9) European Parliament and Council Regulation (EC) no. 1774/2002, as amended
.

10) Act no. 378/2007 Coll., On pharmaceuticals and amending and supplementing some
Related Acts (Pharmaceuticals Act), as amended by Act no. 124/2008 Coll
.

11) Art. 45 Regulation of the European Parliament and Council Regulation (EC) no. 882/2004.