Agreement between the European Community and the United States of America on sanitary measures to protect public and animal health in trade in live animals and animal products

AGREEMENT

between the European Community and the United States of America on sanitary measures to protect public and animal health in trade in live animals and animal products

THE EUROPEAN COMMUNITY,

of the one part, and

THE GOVERNMENT OF THE UNITED STATES OF AMERICA,

of the other part,

DESIRING to safeguard public and animal health and to facilitate trade in animals and animal products between the European Community (hereinafter referred to as ‘the Community’) and the United States of America (hereinafter referred to as ‘the USA’);

RESOLVED to take the fullest account of the risk of spread of animal diseases and the measures put in place to control and eradicate such diseases, and in particular to avoid disruptions to trade;

REAFFIRMING their commitment to the rights and obligations established under the World Trade Organisation Agreement on the application of sanitary and phytosanitary measures (hereinafter referred to as the ‘SPS Agreement’);

WHEREAS the Parties acknowledge that their systems of sanitary measures are intended to address similar objectives of providing comparable health assurances;

NOTING that the recognition by an importing country of the sanitary measures applied by an exporting country can permit greater efficiency in the utilisation of inspection and verification resources;

HAVE DECIDED to conclude this Agreement and to this end have designated respectively as their plenipotentiaries:

THE EUROPEAN COMMUNITY

THE GOVERNMENT OF THE UNITED STATES OF AMERICA

WHO HAVE AGREED AS FOLLOWS:

Article 1

Objective

The objective of this Agreement is to facilitate trade in live animals and animal products between the Community and the USA by establishing a mechanism for the recognition of equivalence of sanitary measures maintained by a Party consistent with the protection of public and animal health, and to improve communication and cooperation on sanitary measures.

Article 2

Multilateral obligations

Nothing in this Agreement shall limit the rights or obligations of the Parties under the Agreement establishing the World Trade Organisation and its Annexes, in particular the SPS Agreement.

Article 3

Scope

Article 4

Regulatory authorities

Article 5

Definitions

For the purposes of this Agreement the following definitions shall apply:

• (a) ‘sanitary measures’ means sanitary measures as defined in Annex A, paragraph 1, of the SPS Agreement and falling within the scope of this Agreement. The reference to sanitary measures may cover individual sanitary measures or groups of sanitary measures for product areas, sectors, or parts of sectors, as appropriate;

• (b) ‘appropriate level of sanitary protection’ means the appropriate level of sanitary protection as defined in Annex A, paragraph 5, of the SPS Agreement;

• (c) ‘region’ means zones or regions as defined in the Animal Health Code of the Office international des epizooties (OIE), and for aquaculture as defined in the International Aquatic Animal Health Code of the OIE;

• (d) ‘Agreement’ means the entire text of this Agreement and all its Annexes.

Article 6

Animal health status

The exporting Party shall, if requested by the importing Party, provide full explanation and supporting data for the determinations and decisions covered by this Article. The importing Party may, where necessary for the protection of animal health, invoke the provisions of Article 12.

Article 7

Equivalence

• (i) identification of the sanitary measure for which recognition of equivalence is sought;

• (ii) explanation by the importing Party of the objective of its sanitary measure, including an assessment, as appropriate to the circumstances, of the risk or risks, that the sanitary measure is intended to address, and identification by the importing Party of its appropriate level of sanitary protection;

• (iii) demonstration by the exporting party that its sanitary measure achieves the importing Party's appropriate level of sanitary protection;

• (iv) determination by the importing party whether a sanitary measure achieves its appropriate level of sanitary protection after consideration of various factors, including where appropriate:
• (a) risks identified by the importing Party and evidence provided by the exporting Party that its sanitary measures effectively address those risks;
• (b) provisions of the exporting Party's legislation and regulations regarding standards, procedures, policies, infrastructure, enforcement and control;
• (c) powers of the exporting Party's regulatory authorities and their structure, including their chain of command, modus operandi, and resources;
• (d) evidence provided by the exporting Party of the efficacy of its enforcement and control programmes. The importing Party may carry out verification, as set out in Article 9, to assist this determination.

Article 8

Status of consultations

2.

• (a) With respect to sanitary measures recognised as equivalent for trade purposes at the date of entry into force of this Agreement, each Party, within its responsibilities, shall initiate the necessary legislative and administrative actions within three months to implement these recognitions. For sanitary measures that will be recognised as equivalent in the future, each Party shall take prompt and necessary steps to implement the recognitions.

• (b) Where the trade conditions specified in Annex V include special conditions required by the importing Party to meet its appropriate level of protection, trade shall take place where the exporting Party meets the importing Party's conditions, without prejudice to the continuing consultative process.

Article 9

Verification provisions

• (a) an assessment of all or part of the exporting Party's total control programme, including, where appropriate, reviews of the exporting Party's inspection and audit programmes, and

• (b) on-site checks and inspections.

• (a) share the results and conclusions of its verification procedures with countries that are not parties to this Agreement, or

• (b) use the results and conclusions of verification procedures carried out by countries that are not parties to this Agreement.

Article 10

Information exchange

• — current developments affecting trade in live animals and animal products,

• — the results of the checks and verification procedures provided for in Article 9.

Article 11

Notification

• (a) immediately by oral communication followed within 24 hours in writing: of any serious or significant public or animal health risk, notably including any food control emergencies or situations where there is a clearly identified risk of serious health effects associated with the consumption of animal products;

• (b) within 24 hours in writing: of the presence or evolution of any disease listed in Annex III;

• (c) without delay and in writing: of any significant changes in animal health status or of findings of epidemiological importance with respect to diseases other than those listed in Annex III; of changes in preventive policies, including vaccination policies; or, of any non-routine measures taken to protect public health or to control or eradicate animal disease.

Article 12

Safeguards

Either Party may take provisional measures necessary for the protection of public or animal health. These measures shall be notified within 24 hours to the other Party, and, on request, consultations regarding the situation shall be held within 14 days. The Parties shall take due account of any information provided through such consultations, and shall endeavour to avoid unnecessary disruption to trade, taking advantage where possible of the provisions of Article 11(3).

Article 13

Outstanding issues

The principles of this Agreement shall also be applied to address outstanding issues listed in Annex VIII. Modifications shall be made to this Annex and, as appropriate, other Annexes, to take account of progress made and new issues identified.

Article 14

Joint Management Committee

When additional expertise is needed, the Parties may also establish ad hoc technical working groups, notably scientific groups, whose membership need not be restricted to representatives of the Parties.

Article 15

Territorial application

This Agreement shall apply, on the one hand, to the territories in which the Treaty establishing the European Community is applied and under the conditions laid down in that Treaty, and on the other hand, to the United States of America in respect of its entire territory.

Article 16

Final provisions

This Agreement shall enter into force on the first day of the month following the date on which the Parties notify each other that the procedures mentioned in the preceding subparagraph have been completed.

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Annexes

ANNEX I	Product coverage
ANNEX II	Regulatory authorities
ANNEX III	List of diseases for which regional freedom is recognised
ANNEX IV	Zoning and regionalisation
ANNEX V	Recognition of sanitary measures
ANNEX VI	Guidelines for conducting an audit
ANNEX VII	Frontier checks
ANNEX VIII	Outstanding issues
ANNEX IX	Contact points

ANNEX I

PRODUCT COVERAGE

Tariff line	General description [^E0001]
01	Live animals
02	Meat and edible meat offal
03	Fish and crustaceans, molluscs and other aquatic invertebrates
04	Dairy produce; birds' eggs; natural honey; edible products of animal origin not elsewhere specified or included
05	Products of animal origin, not elsewhere specified or included, except for products of human origin
1501	Lard; other pig and poultry fat, rendered
1502	Fats of bovine animals, sheep or goats
1503	Lard stearin, lard oil, oleostearin, oleo-oil and tallow oil
1504	Fats and oils and their fractions, of fish and marine mammals
1505	Wool grease and fatty substances derived there from (including lanolin)
1506	Other animal fats and oils and their fractions
1516 10	Animal fats and oils and their fractions
1517	Margarine; edible mixtures or preparations of animal or vegetable fats or oils, except for such products consisting solely of vegetable fats or oils or their fractions
1518	Animal or vegetable fats and oils; inedible mixtures or preparations of animal or vegetable fats or oils or of fractions of different fats or oils of Chapter 15, not elsewhere specified or included, except for such products consisting solely of vegetable fats or oils or their fractions
1522	Degras; residues resulting from the treatment of fatty substances or animal or vegetable waxes, except for such products consisting solely of material of non-animal origin
16	Preparations of meat, of fish or of crustaceans, molluscs or other aquatic invertebrates
1702 10	Lactose and lactose syrup
1901	Malt extract; food preparations of flour, meal, starch or malt extract; food preparations of goods of heading Nos 0401 to 0404, not elsewhere specified or included; except for such products consisting solely of material of non-animal origin
1902	Pasta, whether or not cooked or stuffed (with meat or other substances) or otherwise prepared; couscous, whether or not prepared; except such products consisting solely of products of non-animal origin
2104	Soups and broths and preparations therefor; homogenised composite food preparations; except such products consisting solely of products of non-animal origin
2105	Ice cream and other edible ice, whether or not containing cocoa; except such products consisting solely of products of non-animal origin
2106	Food preparations not elsewhere specified or included; except such products consisting solely of products of non-animal origin
2301	Flours, meals and pellets, of meat or meat offal, of fish or of crustaceans, molluscs or other aquatic invertebrates, unfit for human consumption; greaves; except such products consisting solely of products of non-animal origin
2309	Preparations of a kind used in animal feeding; except such products consisting solely of products of non-animal origin
3001	Glands and other organs for organo-therapeutic uses; heparin and its salts; other animal substances prepared for therapeutic or prophylactic uses; except such products of human origin
3002	Animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products
3101	Animal or vegetable fertilisers, except such products consisting solely of products of non-animal origin
3501	Casein, caseinates and other casein derivatives; casein glues
3502	Albumins, albuminates and other albumin derivatives
3503	Gelatin and gelatin derivatives; isinglass; other glues of animal origin, excluding casein glues of heading No 3501
3504	Peptones and their derivatives; other protein substances and their derivatives, not elsewhere specified or included; hide powder, whether or not chromed
3507	Enzymes; except such products consisting solely of products of non-animal origin
4101	Raw hides and skins of bovine or equine animals
4102	Raw skins of sheep or lambs
4103	Other raw hides or skins
4301	Raw furskins
5101	Wool
5102	Fine or coarse animal hair
5103	Waste of wool or of fine or coarse animal hair
5105	Wool and fine or coarse animal hair
9705	Collections and collectors' pieces of zoological interest

For definitive description refer to tariff code.

ANNEX II

REGULATORY AUTHORITIES

A. UNITED STATES OF AMERICA

I. USA CONTROL AUTHORITY

The federal agencies listed in this section are responsible for both domestically-produced and imported animal products, unless otherwise noted.

In relation to imports into the USA, these agencies are responsible for:

• — conducting frontier checks provided for in the Agreement,

• — carrying out the consultations provided for pursuant to Article 7 of the Agreement,

• — carrying out the verification procedures provided for in Article 9 of the Agreement,

• — carrying out the information exchange provided for in Article 10, the notifications provided for in Article 11, and the safeguards provided for in Article 12 of the Agreement.

In relation to exports from the USA, unless otherwise noted, these agencies are responsible for:

• — controlling the circumstances of domestic production and processing,

• — providing information concerning compliance with agreed regulatory requirements,

• — providing agreed additional guarantees,

• — carrying out the consultations provided for pursuant to Article 7 of this Agreement,

• — carrying out the information exchange provided for in Article 10, the notifications provided for in Article 11, and the safeguards provided for in Article 12 of the Agreement.

A. Control of animal health

1. Animal diseases/pests

• (a) Live animals (including apiculture bees), embryos, ova, semen and animal products — US Department of Agriculture/Animal and Plant Health Inspection Service (USDA/APHIS).

• (b) Imports of salmonid live fish, gametes and fertilised ova — Department of Interior/Fish and Wildlife Service (DOI/FWS).

• (c) Imports of uneviscerated salmonid fish — DOI/FWS.

• (d) Animal feed (including pet foods)
• 1. Transmission of disease from feed — USDA/APHIS.
• 1. Adulteration, pesticides, chemical and microbial contamination, food additives, substances ‘generally recognised as safe’ — Food and Drug Administration (FDA).

B. Control of public health

1. Meat and poultry for human consumption

• (a) Fresh meat and products from domesticated, farmed and wild cattle, sheep, swine, goats and equine — US Department of Agriculture/Food Safety and Inspection Service (USDA/FSIS) ([^E0002])

• (b) Fresh meat and products from domestic and farmed chickens, turkeys, ducks, geese, and guinea fowl — USDA/FSIS ([^E0003]).

• (c) Fresh meat and products from wild and farmed game, with the exception of those from IB1(a) and IB1(b) above — (FDA).

• (d) Fresh meat and products from species other than above — FDA.

• (e) Enforcing adulteration provisions of the law and limits for residues of drugs, pesticides, heavy metals, mycotoxins, and other contaminants in food:
• 1. sampling of fresh meat and animal products and control of the fresh meat and products from domesticated, farmed and wild cattle, sheep, swine, goats, and equine, and for domesticated and farmed chickens (including liquid, frozen and dried egg products), turkeys, ducks, geese, and guinea fowl — USDA/FSIS;
• 1. sampling of fresh meat and animal products (including animal feed) and control of the fresh meat and products of other species — FDA.

2. Eggs and egg products

• (a) Shell eggs, hard-cooked eggs, ethnic egg delicacies, and imitation egg products — FDA.

• (b) Shell eggs (including cracks and dirties) for breaking for the production of liquid, frozen, and dried egg products (egg yolks, albumen, or any combination) — USDA/FSIS ([^E0004]).

3. Dairy

• (a) All dairy products — FDA.

4. Other animal-derived foods (including fish and fishery products)

• (a) All other animal-derived foods — FDA.

5. Animal feed

• (a) Adulteration, pesticides, chemical and microbial contamination, food additives, substances ‘generally recognised as safe’ — FDA.

II.   COMPETENT AUTHORITIES FOR VOLUNTARY PROGRAMMES

The federal agencies listed in this section are responsible for voluntary inspection and certification programmes for domestically-produced animal products.

In relation to exports from the USA, these agencies are responsible for:

• — oversight of the circumstances of domestic production and processing for firms who participate in the voluntary programme,

• — providing information concerning compliance with agreed requirements for firms who participate in the voluntary programme,

• — providing agreed additional guarantees for firms who participate in the agreed programme.

A. Animal health

• 1. Non-salmonid fish and other non-mammalian aquatic animals, gametes and fertilised ova — USDA/APHIS, Department of Commerce/National Marine Fisheries Service (Commerce/NMFS).

• 1. Salmonid live fish, gametes, and fertilised ova — USDA/APHIS, Commerce/NMFS.

• 1. Animal feed (including pet foods) containing fish and fishery products — USDA/APHIS, Commerce/NMFS.

B. Public health

• 1. Fresh meat and meat products ([^E0005]) from wild and farmed bison, ostrich, emu, rhea, rabbit, deer, partridge, and quail — USDA/FSIS.

• 1. Snakes for human consumption — Commerce/NMFS.

• 1. Shell eggs — USDA/AMS.

• 1. Cooked omelets made from egg products, diced eggs made from egg products — USDA/FSIS.

• 1. Dairy — USDA/AMS.

• 1. Seafood (including live seafood) — Commerce/NMFS.

III.   FEDERAL AGENCIES THAT ISSUE CERTIFICATION

This section lists the USA national agencies that issue export certificates agreed to by the EC and the USA ([^E0006]). The agency issuing certificates may be the control authority or another national agency that is recognised by the control authority for that purpose. More than one agency may issue certificates for a product.

	DOC/NMFS	DOI/FWS	FDA	USDA/AMS	USDA/APHIS	USDA/FSIS
A. Animal health certifications	A. Animal health certifications	A. Animal health certifications	A. Animal health certifications	A. Animal health certifications	A. Animal health certifications	A. Animal health certifications
1. Live animals (including apiculture bees), embryos, ova, semen, and products of animal origin					×
2. Non-salmonid fish and other non-mammalian aquatic animals, gametes and fertilised ova	×				×
3. Salmonid live fish, gametes, and fertilised ova	×	×			×
4. Wild waterfowl		×
5. Animal feed	×				×
B. Public health certifications	B. Public health certifications	B. Public health certifications	B. Public health certifications	B. Public health certifications	B. Public health certifications	B. Public health certifications
1. Meat and poultry for human consumption	1. Meat and poultry for human consumption	1. Meat and poultry for human consumption	1. Meat and poultry for human consumption	1. Meat and poultry for human consumption	1. Meat and poultry for human consumption	1. Meat and poultry for human consumption
(a) Fresh meat and products from domesticated, farmed and wild cattle, sheep, swine, goats, and equine, and domesticated and farmed chickens, turkeys, ducks, geese, and guinea fowl						×
(b) Snakes	×		×
(c) Fresh meat and products from species other than above			×			×
2. Eggs	2. Eggs	2. Eggs	2. Eggs	2. Eggs	2. Eggs	2. Eggs
(a) Shell eggs, hard cooked eggs, ethnic egg delicacies, and imitation egg products			×	×
(b) Liquid, frozen and dried egg products						×
3. Dairy	3. Dairy	3. Dairy	3. Dairy	3. Dairy	3. Dairy	3. Dairy
(a) Butter, cheese, frozen desserts, and dried milk products			×	×
(b) Fluid milk			×
4. Seafood	4. Seafood	4. Seafood	4. Seafood	4. Seafood	4. Seafood	4. Seafood
(a) Fish and fishery products including fish oil, reptiles (except snakes), snails and amphibians	×		×
(b) Live fish (including shellfish and molluscs)	×		×

B. EUROPEAN COMMUNITY

Control is shared between the national services in the individual Member States and the European Commission. In this respect the following applies:

• — in terms of exports to the USA, the Member States are responsible for control of the production circumstances and requirements, including statutory inspections, and issuing health certification attesting to the agreed standards and requirements,

• — the European Commission is responsible for overall coordination, inspections/audits of inspection systems and the necessary legislative action to ensure uniform application of standards and requirements within the Single European Market.

ANNEX III

LIST OF DISEASES FOR WHICH REGIONAL FREEDOM IS RECOGNISED

Animal diseases

Foot and mouth disease

Swine vesicular disease

Peste de petits ruminants

Contagious caprine pleuropneumonia

Sheep and goat pox

African swine fever

Enterovirus encephalomyelitis

Newcastle disease

Pseudorabies/Aujeszky's disease

Vesicular stomatitis

Rinderpest

Contagious bovine pleuropneumonia Bluetongue

African horse sickness

Classical swine fever

Fowl plague (avian influenza)

Venezuelan equine encephalomyelitis

Aquaculture diseases

The list of aquaculture diseases is to be discussed further by the Parties on the basis of the International Aquatic Animal Health Code of the OIE.

ANNEX IV

ZONING AND REGIONALISATION

The Parties have jointly determined that the following forms the basis for regionalisation decisions for the diseases listed in accordance with Annex III. Each Party will recognise regionalisation decisions taken in accordance with the standard contained within this Annex.

Animal diseases

In assessing risk from a given proposed importation of animals or animal products, three sets of factors may be considered:

• 1. Source risk factors

• 1. Commodity risk factors

• 1. Destination risk factors

Source risk factors

The primary determinant of the risk of importing disease is the status of the country of origin in respect of the disease in question. However, declarations of disease freedom must be backed up by effective surveillance programmes.

The overriding consideration in this context, therefore, is the quality of the veterinary infrastructure. No other factors can be assessed without full confidence in the veterinary administration. In particular, its ability to detect and control an outbreak of disease and to provide meaningful certification is crucial.

The ability to detect the presence of disease depends on the surveillance carried out. This surveillance can be active, passive, or both.

Active surveillance implies definitive action intended to identify the presence of disease, such as systematic clinical inspections, ante and post mortem examination, serology on farm or in abattoir, referral of pathological material for laboratory diagnosis, sentinel animals.

Passive surveillance means that the disease must be compulsorily notifiable and that there must be a sufficiently high level of supervision of the animals in order to ensure that the disease will be observed quickly and reported as a suspect. There must also be a mechanism for investigation and confirmation, and a high level of awareness of the disease and its symptoms by farmers and veterinarians.

Epidemio-surveillance may be augmented by voluntary and compulsory herd/flock health programmes, particularly those which ensure a regular veterinary presence on the farm.

Other factors to be considered include:

• — disease history,

• — vaccination history,

• — controls on movements into the zone, out of the zone and within the zone,

• — animal identification and recording,

• — presence of disease in adjacent areas,

• — physical barriers between zones of differing status,

• — meteorological conditions,

• — use of buffer zones (with or without vaccination),

• — presence of vectors and/or reservoirs,

• — active control and eradication programmes (where appropriate),

• — ante and post mortem inspection.

On the basis of these factors, a zone may be defined.

The authority with the responsibility for implementing the zoning policy is in the best position to define and maintain the zone. When there is a high level of confidence in that authority, the decisions it makes can be the basis for trade.

The zones so defined may be assigned a risk category.

Possible categories are:

• — low/negligible risk,

• — medium risk,

• — high risk,

• — unknown risk.

Calculation of estimates of risk for, for example, live animals may assist in this categorisation. Import conditions may then be defined for each category, disease and commodity, individually or in groups.

Low/negligible risk implies that importation may take place based on a simple guarantee of origin.

Medium risk implies that some combination of certification and/or guarantees may be required before or after importation.

High risk implies that importation will only take place under conditions which significantly reduce the risk, for example by additional guarantees, testing or treatment.

Unknown risk implies that importation will only take place if the commodity itself is of very low risk, for example hides, wool, or under the conditions for ‘high risk’ if the commodity factors warrant.

Commodity risk factors

These include:

• — is the disease transmissible by the commodity?

• — could the agent be present in the commodity if derived from a healthy and/or clinically affected animal?

• — can the preceding factor be reduced, for example by vaccination?

• — what is the likelihood that the commodity has been exposed to infection?

• — has the commodity been obtained in such a way as to reduce the risk, for example deboning?

• — has the commodity been subjected to a treatment which inactivates the agent?

Appropriate tests and quarantine will reduce the risk.

Destination risk factors

• — presence of susceptible animals,

• — presence of vectors,

• — possible vector-free period,

• — preventive measures such as waste food feeding and animal waste rendering rules,

• — intended use of product for example petfood, human consumption only.

These factors are inherent in, or are under the control of the importing country, and some may therefore be modified to facilitate trade. These may, for example, include restricted entry conditions, for example animals to be confined to a certain vector free region until the incubation period has passed, or canalisation systems.

However, destination risk factors will also be taken into account by the infected country with respect to the risk presented by movements from the infected part to the free part of its territory.

Aquaculture diseases

Pending the development of any specific provisions to be included in this Annex, the basis for regionalisation decisions for aquaculture diseases will be the International Aquatic Animal Health Code of the OIE.

ANNEX V

RECOGNITION OF SANITARY MEASURES