2013 REPORT ON SANITARY 

AND PHYTOSANITARY 

MEASURES

UNITED STATES TRADE REPRESENTATIVE

2013 Report on 

Sanitary and Phytosanitary 

Measures 

Ambassador Demetrios Marantis

Office of the United States Trade Representative

ACKNOWLEDGEMENTS

 

The Office of the United States Trade Representative (USTR) is responsible for the preparation 

of this report. In preparing the report, USTR solicited substantial information from U.S. 

embassies and from interested stakeholders. USTR gratefully acknowledges in particular the 

contributions of all U.S. government staff who contributed to the drafting and review of this 

report. Appreciation is extended to the Executive Branch agencies, including the Environmental 

Protection Agency, the Food and Drug Administration, and the Departments of Agriculture, 

Commerce, and State, for their important contributions and assistance. Finally, special thanks 

go to all U.S. Federal employees who work every day to resolve sanitary and phytosanitary trade 

barriers, helping to expand U.S. food and agricultural exports around the world. 

March 2013

LIST OF FREQUENTLY USED ACRONYMS AND ABBREVIATIONS

AI Avian Influenza

APEC Asia Pacific Economic Cooperation

APHIS USDA's Animal and Plant Health Inspection Service

AQSIQ China’s General Administration of Quality Supervision, 

Inspection, and Quarantine

ASEAN Association of Southeast Asian Nations

BAPHIQ Taiwan’s Bureau of Animal and Plant Health Inspection 

and Quarantine

BiH Bosnia and Herzegovina

BSE Bovine Spongiform Encephalopathy

CAFTA-DR Dominican Republic-Central America-United States Free

Trade Agreement

CAN Andean Community

CARICOM Caribbean Community 

COMESA Common Market for Eastern and Southern Africa

Codex Codex Alimentarius Commission

COFEPRIS Federal Commission for the Protection against Sanitary 

Risk (Mexico)

CTPA Colombia Trade Promotion Agreement

CU Customs Union of the Russian Federation, Kazakhstan, and

Belarus

EEC European Economic Commission

EPA U.S. Environmental Protection Agency

EFSA European Food Safety Authority

EU European Union

FAO United Nations Food and Agriculture Organization

FAS USDA’s Foreign Agricultural Service

FDA U.S. Food and Drug Administration

FMD Foot and Mouth Disease

FSIS USDA’s Food Safety and Inspection Service

FTA Free Trade Agreement

GE Genetically Engineered

HPAI Highly Pathogenic Avian Influenza

IFSTL International Food Safety Training Laboratory

IICA Inter-American Institute for Cooperation on Agriculture

IPPC International Plant Protection Convention

JCCT Joint Commission for Commerce and Trade

JIFSAN Joint Institute for Food Safety and Applied Nutrition

LL601 Liberty Link 601

LMO Act Korea’s Living Modified Organisms Act

LPAI Low Pathogenic Avian Influenza

MAPA Brazil’s Ministry of Agriculture, Livestock and Food 

Supply

MARA Turkey’s Ministry of Agriculture and Rural Affairs
MOU Memorandum of Understanding

MRL Maximum Residue Limit

MT Metric ton

NAFTA North American Free Trade Agreement

NAPPO North American Plant Protection Organization

NEI National Export Initiative

NOAA National Oceanic and Atmospheric Administration

NTE National Trade Estimate Report on Foreign Trade 

Barriers

OIE World Organization for Animal Health

PMWS Post-Weaning Multisystemic Wasting Syndrome

PRA Pest Risk Assessment

PRRS Porcine Reproductive and Respiratory Syndrome

PRT Pathogen Reduction Treatment

RABESA Regional Biotechnology Framework

SADC South African Development Community

SCC Somatic cell count

SENASICA Services for the National Health for Food Safety and Food 

Quality (Mexico)

SPS Sanitary and Phytosanitary

SPS Agreement WTO Agreement on the Application of Sanitary and 

Phytosanitary Measures

SPS Committee WTO Committee on Sanitary and Phytosanitary Measures

SRM Specified Risk Material

STDF Standards and Trade Development Facility

TBT Technical Barriers to Trade

TBT Agreement WTO Agreement on Technical Barriers to Trade

TIFA Trade and Investment Framework Agreement

T&L Traceability and Labeling

TPP TransPacific Partnership

TPSC Trade Policy Staff Committee

TRQ Tariff Rate Quota

TWG Trade Working Group

USAID U.S. Agency for International Development

USDA U.S. Department of Agriculture

USTR Office of the U.S. Trade Representative

WHO World Health Organization

WTO World Trade Organization
FOREWORD

I.

The Office of the United States Trade Representative (USTR) is pleased to publish its fourth 

annual Report on Sanitary and Phytosanitary Measures (SPS Report). This report was created to 

respond to the concerns of U.S. farmers, ranchers, manufacturers, and workers who confront 

sanitary and phytosanitary (SPS) trade barriers as they seek to export high-quality American 

food and agricultural products globally. SPS measures are rules and procedures that 

governments use to ensure that foods and beverages are safe to consume and to protect animals 

and plants from pests and diseases. 

Many SPS measures are fully justified, but too often governments cloak discriminatory and 

protectionist trade measures in the guise of ensuring human, animal, or plant safety. These SPS 

barriers not only harm U.S. farmers, ranchers, manufacturers, workers, and their families, they 

also deprive consumers around the world of access to high-quality American food and 

agricultural goods. USTR is committed to identifying and combating unwarranted SPS barriers 

to U.S. food and agricultural exports. USTR’s efforts to remove unwarranted foreign SPS 

barriers serve the President’s goal of doubling U.S. exports by the end of 2014 through the 

National Export Initiative. 

The United States achieved some important successes since the publication of last year’s report 

in dismantling SPS barriers that blocked U.S. agricultural exports. For example, U.S. negotiators 

removed specific SPS barriers in El Salvador, Hong Kong, Japan, and Mexico for exports of U.S. 

beef; worked with Taiwan to implement a maximum residue limit (MRL) for beef containing 

ractopamine; successfully petitioned the European Union to allow the use of a pathogen 

reduction treatment on beef; resolved barriers for U.S. rough (paddy) rice and poultry products 

for export to Colombia; improved the import procedures for U.S. cherries entering Korea; and 

gained access for certain U.S. pears into China.

In 2013, USTR will continue to work with colleagues from across the U.S. Government, as well 

as interested stakeholders, to encourage other governments to remove their unwarranted SPS 

measures. As always, we will engage other governments in all available bilateral, regional, and 

multilateral fora as part of our efforts to dismantle these barriers to U.S. food and agricultural 

exports and strengthen the rules-based trading system to ensure a level playing field abroad for 

U.S. ranch and farm products. We look forward to making further progress on behalf of 

America’s farmers, ranchers, manufacturers, and workers, as well as families who depend on 

export-supported American jobs. 

Ambassador Demetrios Marantis

Acting U.S. Trade Representative

March 2013

i

TABLE OF CONTENTS

I. EXECUTIVE SUMMARY...................................................................................................... 1

II. INTRODUCTION................................................................................................................... 3

A. Genesis of This Report.................................................................................................. 3

B. SPS Measures – What They Are, Why They Are Needed, and When They Become 

Trade Barriers ............................................................................................................... 4

C. The World Trade Organization Agreement on the Application of Sanitary and 

Phytosanitary Measures................................................................................................ 5

D. Other SPS-Related International Agreements .............................................................. 9

E. International Standard Setting Bodies ........................................................................ 10

F. U.S. Government Agencies......................................................................................... 11

G. Sources of Information about SPS Trade Barriers...................................................... 13

H. U.S. Government Engagement on Foreign SPS Trade Barriers................................. 14

III. MAJOR CROSS-CUTTING SPS ISSUES ....................................................................... 19

A. Export Certification Requirements............................................................................. 19

B. Biotechnology............................................................................................................. 21

C. Bovine Spongiform Encephalopathy .......................................................................... 22

D. Avian Influenza........................................................................................................... 23

E. Maximum Residue Levels for Pesticides.................................................................... 24

IV. COUNTRY REPORTS ....................................................................................................... 27

ARGENTINA ................................................................................................................... 28

AUSTRALIA.................................................................................................................... 29

BAHRAIN ........................................................................................................................ 31
ii

BOLIVIA .......................................................................................................................... 31

BOSNIA AND HERZEGOVINA .................................................................................... 32

BRAZIL............................................................................................................................ 32

CHILE............................................................................................................................... 33

CHINA.............................................................................................................................. 34

COLOMBIA ..................................................................................................................... 38

CROATIA......................................................................................................................... 40

DOMINICAN REPUBLIC............................................................................................... 40

ECUADOR ....................................................................................................................... 40

EGYPT.............................................................................................................................. 41

EL SALVADOR............................................................................................................... 42

ETHIOPIA ........................................................................................................................ 42

EUROPEAN UNION ....................................................................................................... 43

INDIA ............................................................................................................................... 53

INDONESIA..................................................................................................................... 55

ISRAEL............................................................................................................................. 56

JAMAICA......................................................................................................................... 57

JAPAN.............................................................................................................................. 57

KAZAKHSTAN ............................................................................................................... 60

KENYA............................................................................................................................. 62

KOREA............................................................................................................................. 62

KUWAIT .......................................................................................................................... 64

KYRGYZSTAN ............................................................................................................... 65
iii

MACEDONIA .................................................................................................................. 65

MALAYSIA ..................................................................................................................... 65

MEXICO........................................................................................................................... 65

MOROCCO ...................................................................................................................... 68

NEW ZEALAND.............................................................................................................. 68

NORWAY......................................................................................................................... 68

PERU ................................................................................................................................ 69

PHILIPPINES................................................................................................................... 70

RUSSIA ............................................................................................................................ 70

SAUDI ARABIA.............................................................................................................. 75

SERBIA ............................................................................................................................ 75

SINGAPORE.................................................................................................................... 75

SOUTH AFRICA.............................................................................................................. 76

SOUTH AFRICAN DEVELOPMENT COMMUNITY.................................................. 77

SRI LANKA ..................................................................................................................... 77

SWITZERLAND .............................................................................................................. 78

TAIWAN .......................................................................................................................... 78

THAILAND...................................................................................................................... 81

TURKEY .......................................................................................................................... 82

UKRAINE......................................................................................................................... 83

URUGUAY....................................................................................................................... 84

VIETNAM ........................................................................................................................ 85
iv

V. TECHNICAL ASSISTANCE .............................................................................................. 89

APPENDIX.................................................................................................................................. 97
1

I. EXECUTIVE SUMMARY

The 2013 Report on Sanitary and Phytosanitary Measures (SPS Report) is a specialized report 

dedicated to describing significant barriers to U.S. food, farm, and ranch exports arising from 

measures that foreign governments apply on the grounds that such measures are necessary to 

protect human, animal, or plant life or health from risks arising from the entry or spread of plantor animal-borne pests or diseases, or from additives, contaminants, toxins, or disease-causing 

organisms in foods, beverages, or feedstuffs. These measures, known in World Trade 

Organization (WTO) parlance as “sanitary and phytosanitary (SPS) measures,” play an 

increasingly critical role in shaping the flow of global trade. The United States strongly supports 

the right of governments through robust regulatory frameworks to protect their people, animals, 

and plants from health risks of this kind. This report focuses on SPS measures that appear to be 

unscientific, unduly burdensome, discriminatory, or otherwise unwarranted and create significant 

barriers to U.S. exports. Many of these measures can present particular challenges for small and 

medium sized enterprises that typically lack the resources to identify and address such barriers. 

This report is intended to describe and advance U.S. efforts to identify and eliminate these 

unwarranted measures.

Section II of this report presents an overview of SPS measures, describes the relevant 

international agreements governing these measures, and discusses the U.S. and international 

mechanisms for addressing them. In particular, section II covers the following topics: (1) the 

genesis of this report; (2) the growing importance of SPS measures in global trade; (3) rules 

governing SPS measures under the WTO’s Agreement on the Application of Sanitary and 

Phytosanitary Measures (SPS Agreement); (4) rules and mechanisms regarding SPS measures in 

U.S. free trade agreements (FTAs); (5) international standard setting in the SPS area; (6) the role 

of various U.S. Government agencies in addressing SPS-related trade issues; (7) sources of 

information about SPS trade barriers; and (8) U.S. trade policy mechanisms for considering and 

addressing SPS measures, including bilateral engagement and WTO dispute settlement. 

Section III discusses important unwarranted SPS barriers that impede U.S. exports to multiple 

foreign markets. Among the most significant of these cross-cutting barriers are restrictions 

related to export certifications, agricultural biotechnology, bovine spongiform encephalopathy 

(BSE), avian influenza (AI), and maximum residue limits (MRLs) for pesticides. 

The focal point of this report is section IV, which identifies and describes significant 

unwarranted SPS-related trade barriers currently facing U.S. exporters, along with U.S. 

Government initiatives to eliminate or reduce the impact of these barriers. The report identifies 

SPS measures in the following countries and groups of countries: Argentina, Australia, Bahrain, 

Bolivia, Bosnia and Herzegovina, Brazil, Chile, China, Colombia, Croatia, the Dominican 

Republic, Ecuador, Egypt, El Salvador, Ethiopia, the European Union, India, Indonesia, Israel, 

Jamaica, Japan, Kazakhstan, Kenya, Korea, Kuwait, Kyrgyzstan, Macedonia, Malaysia, Mexico, 

Morocco, New Zealand, Norway, Peru, Philippines, Russia, Saudi Arabia, Serbia, Singapore, 

South Africa, the South African Development Community, Sri Lanka, Switzerland, Taiwan, 

Thailand, Turkey, Ukraine, Uruguay, and Vietnam. 
2

Section V discusses the U.S. Government’s efforts to provide technical assistance to developing 

countries on SPS issues. Such assistance is instrumental in U.S. efforts to ensure that countries 

adopt and maintain science-based SPS measures, and help eliminate impediments to U.S. food 

and agricultural exports. 
3

II. INTRODUCTION

A. Genesis of This Report

Shortly after taking office in 2009, President Obama reaffirmed America’s commitment to 

ensuring the effective implementation and enforcement of the WTO system of multilateral 

trading rules. The President’s 2009 Trade Policy Agenda outlined an aggressive and transparent 

program of defending U.S. rights and benefits under the rules-based trading system as a key 

element in his vision to restore the role of trade in leading economic growth and promoting 

higher living standards. The President’s Agenda also recognized that “behind the border” 

measures and other non-tariff barriers have grown in significance for U.S. exporters seeking 

access to foreign markets. 

Since 2009, the USTR has redoubled efforts to break down barriers to U.S. exports. One type of 

non-tariff measure poses increasing challenges to U.S. producers and businesses seeking to 

export products abroad are SPS measures, which are measures that governments apply to protect 

human, animal, or plant life or health from risks arising from the entry or spread of plant- or 

animal-borne pests or diseases, or from additives, contaminants, toxins, or disease-causing 

organisms in foods, beverages, or feedstuffs; and standards-related measures, such as mandatory 

product standards and testing requirements. 

USTR has stepped up monitoring of trading partners’ SPS practices that act as unwarranted 

obstacles to U.S. trade. USTR has also increased engagement to resolve trade issues and to help 

ensure that U.S. trading partners are complying with trade rules – particularly those relating to 

obligations under the SPS Agreement. The goal of this intensified monitoring and engagement is 

to help to facilitate and expand trade in safe, high-quality U.S. food and agricultural products.

In his 2012 State of the Union Address, President Obama called for the creation of an 

interagency trade enforcement unit charged with investigating unfair trading practices. In 

February 2012, President Obama established the Interagency Trade Enforcement Center (ITEC), 

bringing together resources and expertise from across the federal government into one 

organization with a clear, “all hands on deck” commitment to strong trade enforcement. ITEC, 

with a Director appointed by USTR and a Deputy Director appointed by the Secretary of 

Commerce, has assembled critical ITEC infrastructure and staff from a variety of agencies –

including subject matter experts from the U.S. Department of Agriculture (USDA). ITEC 

significantly enhances the U.S. government’s capability to proactively enforce U.S. trade rights 

through investigation of unfair trade practices, including SPS-related trade barriers.

These annual reports have brought new energy to the process of identifying SPS measures that 

act as significant barriers to U.S. exports; to provide a central focus for intensified engagement 

by U.S. agencies in resolving trade concerns related to these barriers; and to document ongoing 

efforts to give greater transparency and confidence to American workers, producers, businesses, 

consumers, and other stakeholders with regard to the actions this Administration is taking on 

their behalf. 
4

First published in 2010, the SPS Report serves these goals. It is dedicated to describing 

significant and unwarranted SPS barriers in foreign countries. Many of these measures were 

previously addressed in the National Trade Estimate Report on Foreign Trade Barriers (NTE 

Report).1 By addressing significant foreign trade barriers in the form of SPS measures, the SPS 

Report meets the requirements under Section 181 of the Trade Act of 1974, as amended, to 

report on significant foreign trade barriers with respect to SPS measures. Accordingly, the 2013

NTE Report itself does not contain information on these measures. A separate report addressing 

significant foreign trade barriers stemming from technical regulations, standards, and conformity 

assessment procedures (2013 Report on Technical Barriers to Trade, or TBT Report) is being 

released in parallel with the SPS Report.

The SPS Report begins with an overview of SPS measures and the international trade rules that 

govern them. It then summarizes the manner in which the U.S. Government addresses SPS trade 

barriers in other countries. Next, the SPS Report discusses certain cross-cutting SPS trade 

barriers that U.S. producers face in a number of different markets. The next section, comprising 

the focal point of the SPS Report, identifies and describes SPS trade barriers on a country-bycountry basis, along with a description of U.S. Government engagement on these issues. The 

SPS Report concludes with a discussion of the U.S. Government’s efforts to provide technical 

assistance to developing countries on SPS issues.

Like the NTE Report, the source of the information for the SPS Report includes stakeholder 

comments that USTR solicited through a notice published in the Federal Register, reports from 

U.S. embassies and from other federal agencies, and USTR’s ongoing consultations with 

domestic stakeholders and trading partners. An appendix provides a list of entities that 

submitted comments in response to the Federal Register notice.

B. SPS Measures – What They Are, Why They Are Needed, and When They Become 

Trade Barriers

As noted above, SPS measures are those laws, decrees, regulations, requirements, and 

procedures that governments apply to protect human, animal, or plant life or health from risks 

arising from the entry or spread of plant- or animal-borne pests or diseases, or from additives, 

contaminants, toxins, or disease-causing organisms in foods, beverages, or feedstuffs. For 

example, the United States and other governments routinely apply measures at the border to 

protect domestic crops or livestock from imported agricultural products or animals that may 

introduce a plant pest or animal disease into the country. Many countries also have established 

MRLs for pesticide residues in food to promote the safe use of pesticides on food, as well as 

requirements that imported fruits, vegetables, and feed products be treated to eliminate a 

particular pest to protect plant health. In addition, governments often require live animals to be 

 

1

In accordance with section 181 of the Trade Act of 1974 (the 1974 Trade Act), as amended by section 303 of the 

Trade and Tariff Act of 1984 (the 1984 Trade Act), section 1304 of the Omnibus Trade and Competitiveness Act of 

1988 (the 1988 Trade Act), section 311 of the Uruguay Round Trade Agreements Act (the 1994 Trade Act), and 

section 1202 of the Internet Tax Freedom Act, the Office of the U.S. Trade Representative is required to submit to 

the President, the Senate Finance Committee, and appropriate committees in the House of Representatives, an 

annual report on significant foreign trade barriers. The statute requires an inventory of the most important foreign 

barriers affecting U.S. exports of goods and services, foreign direct investment by U.S. persons, and protection of 

intellectual property rights.
5

subject to veterinary health examinations, disease testing, and sometimes pre- or post-entry 

quarantine. 

At times, however, some governments impose SPS measures that are disguised protectionist 

barriers to trade, not grounded in science, or that are otherwise unwarranted, and which create 

substantial obstacles to U.S. exports. For example, many countries have used the threat of AI or 

BSE as a reason to block U.S. poultry and beef exports, respectively, ignoring international 

science-based standards that establish appropriate measures for addressing those diseases. 

Maintaining dependable export markets for U.S. agricultural producers is critical to this nation’s 

economic health. Overall, U.S. farm exports totaled $145.4 billion in 2012. According to 

USDA’s Economic Research Service, each $1 billion in U.S. agricultural exports supports 

approximately 6,800 jobs on and off the farm. At the same time, however, SPS trade barriers 

prevent U.S. producers from shipping hundreds of millions of dollars’ worth of goods, hurting 

farms and small businesses. The elimination of unwarranted SPS foreign trade barriers is a high 

priority for the U.S. Government.

The U.S. Government’s pursuit of both goals – safeguarding the United States from risks to 

human, animal, or plant life or health as discussed above, and aggressively defending the 

interests of U.S. producers in exporting safe, wholesome products to foreign markets – are fully 

consistent. The United States and other governments have a legitimate and sovereign right to 

adopt and enforce measures to protect their people, animals, and plants from SPS-related risks. 

At the same time, it is appropriate to question SPS measures that appear to be discriminatory, 

unscientific, or otherwise unwarranted and therefore, that do not serve to guard against legitimate 

health and safety risks but rather act to protect domestic or favored foreign products. 

C. The World Trade Organization Agreement on the Application of Sanitary and 

Phytosanitary Measures 

The SPS Agreement, to which all WTO Members are parties, explicitly recognizes that 

governments have the right to adopt regulations to protect human, animal, or plant life or health 

– including food safety regulations and measures to protect domestic crops, livestock, and 

poultry – and to establish the levels of protection from risk they deem appropriate. Starting from 

that premise, the SPS Agreement establishes a number of general requirements and procedures to 

ensure that governments adopt and apply SPS measures to protect against real risks rather than to 

protect local products from import competition. The SPS Agreement also encourages 

harmonization of SPS measures among WTO Members, where appropriate. 

Some of the more important elements of the SPS Agreement are described in this section. 

The Scope of the SPS Agreement

The SPS Agreement applies only to those governmental measures that may directly or indirectly 

affect international trade. If a measure has no trade effect or is imposed by a private company or 

trade association, the SPS Agreement does not apply to it. The Agreement defines SPS measures 

as any measure that a WTO Member applies: 
6

- to protect animal or plant life or health within the territory of the Member from risks 

arising from the entry, establishment or spread of pests, diseases, disease-carrying 

organisms or disease-causing organisms; 

- to protect human or animal life or health within the territory of the Member from risks 

arising from additives, contaminants, toxins, or disease-causing organisms in foods, 

beverages or feedstuffs; 

- to protect human life or health within the territory of the Member from risks arising from 

diseases carried by animals, plants or products thereof, or from the entry, establishment 

or spread of pests; or

- to prevent or limit other damage in the territory of the Member from the entry, 

establishment or spread of pests. 

SPS measures include all relevant laws, decrees, regulations, requirements, and procedures 

including, among others: end product criteria; processes and production methods; testing, 

inspection, certification, and approval procedures; quarantine treatments, including relevant 

requirements associated with the transport of animals or plants, or with the materials necessary 

for their survival during transport; provisions on relevant statistical methods, sampling 

procedures, and methods of risk assessment; and packaging and labeling requirements directly 

related to food safety. 

Appropriate Level of Protection

As noted above, the SPS Agreement explicitly recognizes the right of WTO Members to take 

SPS measures necessary to protect human, animal, or plant life or health. An important question 

is how much protection a Member may seek against a particular risk when it adopts an SPS 

measure. Under the SPS Agreement, each Member is free to choose its own “appropriate level 

of sanitary or phytosanitary protection.” 

Science-Based Measures

Once a WTO Member has established its appropriate level of protection, the SPS Agreement 

provides that the SPS measures it takes to achieve that level of protection must be based on 

scientific principles, must not be maintained without sufficient scientific evidence, and may be 

applied only to the extent necessary to protect human, animal, or plant life or health. In cases 

where relevant scientific evidence is insufficient, a government may provisionally adopt SPS 

measures on the basis of available information. In such circumstances, WTO Members shall 

seek to obtain the additional information necessary for a more objective assessment of risk and 

review the SPS measure accordingly within a reasonable period of time.
7

Risk Assessment 

The SPS Agreement requires each Member to ensure that its SPS measures are based on an 

assessment, as appropriate to the circumstances, of the risk that a particular substance or product, 

including a process or production method, poses to human, animal, or plant life or health. 

Unjustifiable Discrimination and Disguised Restrictions on Trade

While each WTO Member is free to choose the level of protection it considers appropriate, the 

SPS Agreement requires Members to ensure that their SPS measures are not more traderestrictive than required to achieve that level of protection, taking into account technical and 

economic feasibility. It also requires governments to avoid arbitrary or unjustifiable distinctions 

in the levels of protection in different situations if such distinctions result in discrimination 

against a good from another WTO Member or constitute a disguised restriction on international 

trade. 

Harmonization

The SPS Agreement calls for governments to base their SPS measures on international standards, 

guidelines, and recommendations developed by international standard setting organizations. The 

objective in promoting the use of international standards is to facilitate trade by harmonizing 

different WTO Members’ SPS measures on as wide a basis as possible. The three recognized 

standard-setting bodies in the SPS Agreement are: (1) the Joint Food and Agricultural 

Organization of the United Nations (FAO)/World Health Organization (WHO) Codex 

Alimentarius Commission (Codex) for food safety; (2) the FAO International Plant Protection 

Convention (IPPC) for plant health; and (3) the World Organization for Animal Health, formerly 

known as the International Office of Epizootics (OIE), for animal health and zoonoses. A WTO 

Member may depart from an international standard, guideline, or recommendation only if the 

Member’s measure is in accordance with the obligations of the SPS Agreement. 

Transparency

The SPS Agreement requires WTO Members to publish promptly all adopted SPS measures in a 

manner that enables other interested WTO Members to become acquainted with them prior to 

their entry into force. The SPS Agreement also requires each Member to maintain an enquiry 

point that is responsible for providing relevant documents and answers to all reasonable 

questions from interested Members concerning SPS regulations adopted or proposed in the 

Member’s territory. In addition, the SPS Agreement requires each WTO Member to publish any 

proposed SPS measure that is not based on an international standard, guideline, or 

recommendation and that may have a significant effect on trade, and to provide other Members 

with prior notice and an opportunity to comment on the proposal, except where “urgent problems 

of health protection” are involved. 

The United States takes its transparency obligations very seriously and encourages other WTO 

Members to do the same. Since the WTO was established in 1995, the United States has 

submitted an average of 158 SPS notifications per year. 
8

SPS Committee 

The SPS Agreement established a Committee on Sanitary and Phytosanitary Measures (SPS 

Committee) to provide a regular forum at the WTO for consultations about SPS measures that 

affect trade and to oversee the implementation of the SPS Agreement. 

The SPS Committee is open to all WTO Members as well as governments that have observer 

status in higher level WTO bodies. The U.S. delegation to the SPS Committee is led by USTR, 

and includes representatives from USDA, the U.S. Environmental Protection Agency (EPA), the 

U.S. Food and Drug Administration (FDA), and the U.S. Departments of Commerce and State. 

The United States is an active participant at SPS Committee meetings, where it regularly raises 

issues for Members to consider. In addition to participating WTO Members, the SPS Committee 

has invited representatives of several international intergovernmental organizations to attend as 

observers. Among the observers have been representatives from Codex, the OIE, the IPPC, and 

the WHO. 

The agenda for SPS Committee meetings varies, but several items appear regularly. Committee 

members routinely discuss matters related to how the SPS Agreement is being applied and 

implemented and specific trade concerns, such as minimum residue levels for pesticides. 

Members also discuss and develop procedures and guidelines that help governments implement 

their obligations under the SPS Agreement. All procedures and guidelines that the SPS 

Committee establishes must be adopted by consensus. 

Since 2002 the United States has raised 192 items of trade concern during the formal, on the 

record, WTO SPS Committee meetings.

Technical Assistance

The SPS Agreement encourages all Members to facilitate technical assistance to developing 

country Members either bilaterally or through relevant international organizations, such as the 

Standards and Trade Development Facility (STDF), the Inter-American Institute for Cooperation 

on Agriculture (IICA), and Asia-Pacific Economic Cooperation (APEC). The STDF is a joint 

initiative of the WTO, FAO, OIE, and WHO aimed at raising awareness on the importance of 

SPS issues, increasing coordination in the provision of SPS-related assistance, and mobilizing 

resources to assist developing countries enhance their capacity to meet SPS standards. The IICA 

is a specialized agency of the Inter-American System, whose purpose is to encourage and 

support the efforts of its Member States to achieve agricultural development and well-being for 

rural populations. APEC is a forum for facilitating economic growth, cooperation, trade and 

investment in the Asia-Pacific region, by creating an environment for the safe and efficient 

movement of goods, services and people across borders in the region through policy alignment, 

and economic and technical cooperation. Effective and targeted capacity-building and technical 

assistance play important roles in creating a transparent and science-based environment as 

envisioned under the SPS Agreement, thus supporting APEC’s trade and investment 

liberalization agenda.
9

The U.S. Government has put into place a number of programs that provide technical assistance 

to developing countries to help these countries meet their international obligations with respect 

to SPS measures and thereby facilitate trade in agricultural products. This assistance takes 

various forms, including training seminars, laboratory training, advice on drafting rules and 

regulations, staff internships, and data sharing. U.S. technical assistance is discussed in greater 

detail in section V of this report. 

D. Other SPS-Related International Agreements

The North American Free Trade Agreement 

Because the North American Free Trade Agreement (NAFTA) entered into force before the 

WTO was established, and thus before there were multilateral disciplines on SPS measures, the 

NAFTA contains a much more detailed SPS chapter than later U.S. FTAs. For example, the 

NAFTA imposes specific disciplines on the development, adoption, and enforcement of SPS 

measures. As is the case with the SPS Agreement, the NAFTA SPS disciplines are designed to 

prevent the use of SPS measures as disguised restrictions on trade, while still safeguarding each 

Party’s right to protect consumers from unsafe products, or to protect domestic crops and 

livestock from the introduction of imported pests and diseases.

The NAFTA encourages the three NAFTA Parties (the United States, Canada, and Mexico) to 

adopt international and regional standards, while at the same time explicitly recognizing each 

Party's right to determine its appropriate level of protection. Such flexibility permits each Party 

to set standards that are more stringent than international guidelines, as long as those standards 

are scientifically-based. 

The NAFTA Committee on SPS Measures promotes the harmonization and equivalence of SPS 

measures between the three Parties and facilitates technical cooperation, including consultations 

regarding disputes involving SPS measures. The Committee meets periodically to review and 

resolve SPS issues. 

The NAFTA SPS Committee also hosts a number of technical working groups (TWGs) that have 

served to enhance regulatory cooperation and facilitate trade between the three NAFTA 

countries. TWGs address trade issues and national regulatory and scientific review capacity. 

They also coordinate regulatory decision-making to reduce the burden on industry. For example, 

the NAFTA TWG on pesticides has created a venue for collaboration between U.S. EPA’s 

Office of Pesticides Programs and its counterparts in Canada and Mexico. The primary objective 

of this working group is to enhance cooperation and harmonize pesticide standards while 

maintaining and enhancing standards of food safety, public health, and environmental protection. 
10

Other U.S. Free Trade Agreements 

Most FTAs that the United States has concluded since the WTO was inaugurated in 1995 include 

an SPS chapter.2 While those chapters do not impose new or additional substantive rules or 

obligations, many of these agreements establish SPS committees that provide a forum for the 

parties’ trade and regulatory authorities to resolve contentious bilateral or regional SPS issues, 

consult on SPS matters that are pending before relevant international organizations, and 

coordinate technical cooperation programs. 

E. International Standard Setting Bodies 

As noted above, the WTO officially recognizes three standard setting bodies to deal with SPS 

matters: the Codex for food safety, the OIE for animal health and zoonoses, and the IPPC for 

plant health. U.S. Government experts participate actively in these organizations, which meet 

periodically to discuss current and anticipated threats to human and agricultural health, evaluate 

scientific issues surrounding SPS-related issues, and develop internationally recognized SPS 

standards based on science. These standards are voluntary and are intended to provide guidance 

for governments in formulating their own national SPS measures and, ultimately, to help avoid 

and resolve disputes over appropriate SPS measures. As discussed below, various USDA 

agencies lead the U.S. delegations to these three international bodies. The United States strongly 

encourages its trading partners to adopt the standards set by Codex, IPPC, and the OIE. 

In recent years, the United States has supported a number of important standards developed by 

these international bodies. For example, the OIE has worked to promulgate science-based 

guidelines to be followed in the event that a potentially dangerous strain of AI is detected. 

According to these guidelines, unprocessed poultry products from countries that report detections 

of low pathogenic avian influenza (LPAI) may be traded with minimal restrictions, and countries 

reporting highly pathogenic avian influenza (HPAI) may trade safely in poultry and poultry 

products under specified conditions. The guidelines, however, do not recommend any type of 

import bans on poultry commodities from countries with non-notifiable subtypes of AI. 

More recently, on July 5, 2012, Codex adopted eight standards for the maximum residue levels 

for ractopamine in beef and pork. Ractopamine is a feed ingredient for cattle and swine, which 

results in increased weight gain, an increase in the yield of red meat, and leaner meat 

production. The Codex standards, which are based on science and a risk assessment, provide 

clear guidance to countries on the safe use of ractopamine. Ractopamine has been approved by 

the U.S. Food and Drug Administration and is being used safely in the United States and 25 

other countries.

 

2 Among the U.S. Free Trade Agreements that include an SPS chapter are the United States – Australia FTA, the 

United States – Bahrain FTA, the United States – Chile FTA, the United States – Colombia Trade Promotion

Agreement (TPA), the Dominican Republic – Central America – United States FTA (CAFTA – DR), the United 

States – Korea FTA, the United States – Oman FTA, the United States – Panama TPA, and the United States – Peru 

TPA. The United States – Morocco FTA does not have a stand-alone SPS chapter, but does include various SPS 

provisions in its agriculture chapter. 
11

F. U.S. Government Agencies 

The Executive Branch has robust policies and procedures in place for addressing and resolving 

SPS trade barriers in other countries. The following discussion describes the roles that the 

relevant federal agencies play in that effort.

Office of the United States Trade Representative 

USTR, an agency within the Executive Office of the President, is responsible for developing and 

coordinating U.S. international trade policy and overseeing negotiations with other countries, 

including with respect to foreign SPS measures. USTR meets with governments, business 

groups, legislators, public interest groups, and other interested parties to gather input on SPS 

issues and to discuss trade policy and negotiating positions. USTR then coordinates U.S. trade 

policy through an interagency structure (as discussed below). USTR plays a variety of roles with 

regard to trade barriers generally, including SPS barriers, such as by serving as the lead U.S. 

agency in negotiating bilateral, regional, and multilateral trade agreements and lead U.S. counsel 

in all WTO disputes. 

The head of USTR is the U.S. Trade Representative, a Cabinet member who serves as the 

President’s principal trade advisor, negotiator, and spokesperson on SPS and other trade issues. 

Created in 1962, USTR has offices in Washington and Geneva, and posts representatives in 

Beijing and Brussels. 

U.S. Department of Agriculture 

USDA plays a key role in addressing foreign SPS trade barriers as the vast majority of these 

barriers are restrictions on U.S. agricultural exports. In particular, three USDA agencies, the 

Foreign Agricultural Service (FAS), the Animal and Plant Health Inspection Service (APHIS), 

and the Food Safety and Inspection Service (FSIS), are engaged actively in interagency 

deliberations and coordination, as well as in the direct engagement with U.S. trading partners on 

SPS matters. 

Foreign Agricultural Service 

FAS coordinates and executes USDA’s strategy to obtain foreign market access for U.S. 

products (including addressing SPS barriers to U.S. exports), build new markets, improve the 

competitive position of U.S. agriculture in the global marketplace, and provide food aid and 

technical assistance to foreign countries. FAS has primary responsibility for USDA’s 

international activities – market development, trade agreements and negotiations, and the 

collection and analysis of statistics and market information. To perform these tasks, FAS relies 

on its global network of overseas offices with staff in over 90 foreign countries that monitor 

policies and other developments that could affect U.S. agricultural exports. FAS collects and 

analyzes information that a number of U.S. agencies use to develop strategies to increase market 

access, monitor trade agreements, and improve programs and policies to make U.S. agricultural 

products more competitive. FAS also provides significant funding to address SPS trade barriers 

under the Technical Assistance for Specialty Crops (TASC) program. The pest research, field 
12

surveys, and pre-clearance programs funded by TASC play an important role in supporting 

efforts to remove such trade barriers. FAS is a member of the U.S. delegation to the WTO SPS 

Committee and is an active member of all other interagency teams dealing with SPS issues.

Animal and Plant Health Inspection Service 

APHIS works to prevent the spread of agricultural pests and diseases affecting animals and 

plants in the United States and to foster safe agricultural trade, thus serving to ensure an 

abundant, high-quality, and varied food supply worldwide. As a result of its expertise, APHIS 

plays a key role in addressing foreign agricultural trade barriers by developing and advancing 

science-based standards with U.S. trading partners to ensure that U.S. agricultural exports do not 

face unwarranted SPS restrictions. APHIS leads the U.S. Government delegation to the OIE and 

IPPC and actively participates in helping shape the draft animal and plant health standards 

proposed by these international organizations. APHIS also serves as a member of the U.S. 

delegation to the WTO SPS Committee and is an active member of all other SPS issues.

Food Safety and Inspection Service 

FSIS is USDA’s public health agency, responsible for ensuring that the nation’s commercial 

supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and 

packaged. FSIS has significant expertise in addressing SPS barriers that foreign governments 

apply to U.S. exports of these products. FSIS is the U.S. Government coordinator for Codex 

meetings, as well as an active member of the U.S. delegation to the WTO SPS Committee and 

other interagency teams dealing with SPS issues.

U.S. Environmental Protection Agency 

EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) regulates pesticide use in 

the United States to protect human health and the environment; establishes MRLs to ensure 

safety of both domestically produced and imported foods; promotes the use of safe means of pest 

control; and establishes standards and requirements regarding sound pesticide and chemical 

management practices based on science. OCSPP has the lead role in coordinating EPA activities 

with respect to SPS measures of other countries, particularly pesticide MRLs and agricultural 

biotechnology. EPA is a member of the U.S. delegation to the WTO SPS Committee and is an 

active member of all other interagency teams dealing with SPS issues. 

U.S. Food and Drug Administration 

The FDA is the public health regulatory agency responsible for the safety of most of the nation’s 

domestically produced and imported foods, as well as food additives and dietary supplements. In 

addition, FDA’s regulatory authority covers the manufacture and distribution of food additives 

and drugs intended for use in animals. To work more effectively with foreign regulators, 

industry, and other stakeholders to promote product safety, FDA has recently established posts in 

strategic locations around the globe, including Belgium, Chile, China, Costa Rica, India, Jordan, 

Mexico, South Africa, and the United Kingdom (UK). FDA takes an active role in assessing 

foreign SPS measures, participates in the interagency process to address food safety issues, and 
13

is a member of the U.S. delegation for the WTO SPS Committee. FDA is also an active member 

of other interagency teams dealing with SPS issues such as those arising under U.S. FTAs.

U.S. Department of Commerce

The Market Access and Compliance (MAC) unit at the U.S. Department of Commerce leads the 

Trade Agreements Compliance (TAC) Program, which supports the enforcement side of the 

National Export Initiative (NEI). Under the TAC Program, MAC coordinates U.S. Government 

efforts and resources to systematically monitor, investigate, and ensure that foreign governments 

comply with the over 250 international trade agreements to which the United States is party. The 

TAC Program represents the U.S. Government’s focal point for identifying foreign trade barriers 

that obstruct U.S. exporter market access. Commerce works closely with its interagency 

colleagues to address SPS-related trade barriers, as well as all matters pending before the SPS 

Committee. In addition, to advance the NEI’s advocacy efforts, the Department’s United States 

and Foreign Commercial Service (U.S. & FCS) works with U.S. companies to help them expand 

market access opportunities abroad. The U.S. & FCS operates in 93 U.S. cities and in 73 

countries around the world. The Department of Commerce is a member of the U.S. delegation to 

the WTO SPS Committee and is an active member of all other interagency teams dealing with 

SPS issues. Additionally, MAC coordinates SPS-related work at the Department of Commerce 

including work done by the Manufacturing and Services (MAS) unit on issues concerning U.S. 

industry and manufacturers.

U.S. Department of State

The U.S. Department of State is responsible for carrying out the foreign policy of the United 

States. With a diplomatic presence in 190 countries, the Department of State provides on-theground context for foreign government actions on SPS measures. Department of State officers 

advocate for fair treatment of U.S. products that may be subject to unwarranted trade barriers. 

The Department of State is an active participant in interagency deliberations and policy 

formulation concerning SPS measures, as well as part of the U.S. delegation to the WTO SPS 

Committee. 

G. Sources of Information about SPS Trade Barriers

The United States maintains a vigorous process for identifying SPS measures that create 

unwarranted barriers to U.S. exports. USTR and other agencies learn of issues directly from 

concerned U.S. businesses and industries, farm and consumer organizations, and other 

stakeholders. U.S. agencies also rely on an extensive network of U.S. Government officials 

stationed around the globe, particularly in embassies that house both State Department and FAS 

representatives.

In addition, the United States receives formal notifications under WTO procedures when WTO 

Members are considering making changes in their SPS measures. FAS coordinates an 

interagency team that reviews these notifications on a weekly basis and consults with 

stakeholders including industry and consumer organization advisers. Where warranted, the 

United States submits comments to the relevant WTO Member on the potential trade effects or 
14

scientific concerns that may arise from the changes it is considering. In 2012 alone, the 

interagency group reviewed 908 SPS notifications by 50 WTO Members and provided comments 

to these trading partners on 119 proposed or in-force SPS measures.

Slightly more than 15 percent of the comments were on measures regarding processed products; 

nearly 45 percent of the comments addressed requirements for live animals and fish (and their 

products, including dairy products); and about 40 percent of the comments were for measures 

that introduced new standards or entry requirements for plants, bulk commodities (including U.S. 

agricultural products derived from modern biotechnology), and horticultural products. The 

leading recipients of U.S. Government comments included the Republic of Korea with 13 

comments, the European Union with 9 comments, and China, Chinese Taipei, Colombia, and 

Qatar with 8 comments each.

As part of these submissions, the United States requested its trading partners to take a number of 

actions, including the following: change or reduce product certification requirements; modify 

requirements of a measure; repeal an import ban; rescind entry requirements; delay 

implementation of a measure; and reduce testing fees. The United States also requested its 

trading partners to adopt the international standards of Codex, the IPPC, and the OIE where 

appropriate.

H. U.S. Government Engagement on Foreign SPS Trade Barriers 

The United States maintains a broad and active agenda of engagement, both to prevent the 

adoption of SPS measures that would create unnecessary barriers to U.S. exports and to resolve 

specific SPS trade concerns. 

Interagency Consultation

Before formally engaging a foreign government with respect to a proposed or existing SPS 

measure, USTR generally consults with other federal agencies that participate in addressing trade 

policy matters. USTR coordinates SPS policy through a multi-tiered interagency process. The 

Trade Policy Staff Committee (TPSC), with representation at the senior civil service level, serves 

as the primary operating body for this interagency process. A TPSC subcommittee specifically 

devoted to addressing SPS matters supports the TPSC’s deliberations. 

Levels of Engagement 

The U.S. Government addresses SPS trade issues and unwarranted barriers in a variety of ways. 

As discussed above, the United States provides comments to foreign governments, when 

appropriate on SPS measures that those governments have notified to the WTO. In addition, 

FAS and State Department officials stationed at U.S. embassies frequently identify proposed 

foreign SPS measures and transmit U.S. Government comments on proposed foreign SPS 

measures to the relevant foreign government officials. In parallel with these comments, FAS and 

State Department representatives typically ask the government concerned to provide a formal 

written response and to arrange meetings between their relevant regulatory authorities and FAS 

representatives so that they can describe U.S. concerns in detail. FAS and State Department 
15

officials submit reports on these meetings to the relevant U.S. agencies for their collective

consideration. Depending on the nature of the specific measure, the interagency team may 

request technical experts of the pertinent U.S. regulatory agency to meet with their counterparts 

in the relevant country to discuss U.S. concerns and, where appropriate, to propose reasonable 

alternatives that are less trade restrictive. 

If the United States is unable to resolve an SPS concern through these methods, USTR, 

following coordination with the TPSC, may elect to request a meeting with the country’s senior 

regulatory and trade agency representatives, or may decide to raise the matter during a regularly 

scheduled bilateral meeting with the trading partner at the WTO SPS Committee meeting in 

Geneva. In addition, USTR may decide to address the issue in the contest of a meeting convened 

under the appropriate bilateral or regional U.S. FTA, or Trade Investment Framework 

Agreement (TIFA), or decide to pursue the issue during the course of a formal WTO SPS 

Committee meeting, where all WTO Members will have the opportunity to listen and comment 

on the issue at hand. USTR leads these discussions and works closely with the relevant 

regulatory agencies to address the relevant concern. If the issue cannot be resolved through 

bilateral consultations, USTR may ask the U.S. Ambassador in the country concerned to raise the 

matter with the appropriate senior foreign government officials. 

WTO Dispute Settlement 

If none of these methods of engagement is successful in resolving a particular concern, USTR 

may conclude that a bilaterally agreed approach is not possible. At that point, if the trading 

partner is a WTO Member, and if the United States considers that measure is inconsistent with 

WTO rules, the United States may decide to assert its rights under the SPS Agreement through 

the WTO’s dispute settlement system. Since the WTO was established in 1995, the United 

States has successfully challenged other Members’ SPS measures in four separate proceedings, 

one proceeding is suspended, and a sixth proceeding is currently underway. These proceedings 

are described below.

European Communities – Hormones3

In 1996, the United States challenged the European Union’s (EU) ban on beef derived from U.S. 

cattle that have been treated with certain growth-promoting hormones. In 1998, the WTO found 

that the EU’s ban was not supported by science and was thus inconsistent with the EU’s 

obligations under the SPS Agreement. Accordingly, in 1999, following authorization from the 

WTO’s Dispute Settlement Body, the United States raised its duties on a list of EU exports.

In May 2009, the United States and the EU concluded a Memorandum of Understanding (MOU) 

that has enabled U.S. producers to gain additional duty-free access to the EU market for highquality beef produced from cattle that have not received growth-promoting hormones. The 

MOU took effect in August 2009. In August 2012, the United States and the EU entered into the 

second phase of the MOU, resulting in an increased EU TRQ for high-quality beef. Consistent 

with its obligations under the second phase of the MOU, the United States is no longer applying 

increased duties on EU products pursuant to its authorization from the Dispute Settlement Body 

 

3 Before 2010 the European Union was referred to for purposes of the WTO as the European Communities. 
16

in the EC – Hormones dispute. The United States continues to monitor EU implementation of 

the MOU and other developments affecting market access for U.S. beef products.

Japan – Varietal Testing

In 1997, the United States challenged Japan’s varietal testing requirement, which prohibited the 

importation of certain fruits and nuts on the basis that they could become potential hosts for 

codling moths. In 1999, the WTO found that Japan’s restrictions were maintained without 

sufficient scientific evidence and that they were not based on a risk assessment. In 2001, the 

United States and Japan reached a mutually agreed solution to end the dispute, allowing U.S. 

exporters to regain market access in Japan.

Japan – Apples

In 2002, the United States challenged Japan’s restrictions on imports of U.S. apples, which were 

based on concerns over the introduction of fire blight. The WTO found in 2003 that Japan’s 

restrictions were inconsistent with its obligations under the SPS Agreement. In particular, the 

WTO found that Japan’s measures were maintained without sufficient scientific evidence and 

were not based on a risk assessment. In 2005, a WTO compliance panel found that Japan had 

not complied with the WTO’s recommendations and rulings. Later that year, Japan and the 

United States reached a mutually agreed solution to provide access for U.S. apples to Japan’s 

market.

European Communities – Agricultural Biotechnology

In 2003, the United States challenged the EU’s de facto moratorium on approvals of U.S. 

agricultural products derived from modern biotechnology, such as certain corn and soybean 

varieties, as well as marketing prohibitions that individual EU Member States had imposed on 

agricultural biotechnology products that the EU had previously approved. In 2006, a WTO panel 

found that EU and Member State measures were inconsistent with WTO rules. This dispute 

remains unresolved. As of December 31, 2012, a large backlog of 72 applications (for approval 

of import, renewal, and cultivation) remains pending in the EU approval system, which has the 

effect of blocking U.S. exports of certain agricultural products. The EU approved six products 

(five import and one renewal) in 2012, taking an average of 40 months to reach a decision. The 

United States continues to press the EU for fundamental improvements in its regulatory system 

with the goal of normalizing trade in agricultural products derived from modern biotechnology.

European Union – Poultry

At the request of the United States, the WTO established a dispute settlement panel in November 

2009 to examine whether the EU’s restrictions on imports of U.S. poultry are consistent with its 

obligations under the SPS Agreement. The dispute is focused on the EU's ban on the import and 

marketing of poultry meat and poultry meat products processed with certain pathogen reduction 

treatments (PRTs) used in the United States that both U.S. and European scientists have judged 

to be safe. 
17

India – Restrictions on Certain U.S. Agricultural Products

On March 6, 2012, the United States requested consultations with India under the dispute 

settlement provisions of the WTO regarding India’s measures that serve to preclude the import of 

certain U.S. agricultural products. India’s measures are purportedly for the purpose of preventing 

the entry of avian influenza. The United States is concerned that India has not provided a valid, 

scientifically-based justification for its measures.

The United States and India held consultations on April 16-17, 2012, but were unable to resolve 

the dispute. The United States requested the establishment of a WTO panel on May 24, 2012. 

At its meeting on June 25, 2012, the WTO dispute settlement body established a panel. 

19

III. MAJOR CROSS-CUTTING SPS ISSUES

Some U.S. food and agricultural exports are subject to similar unwarranted SPS barriers in 

multiple markets. This year’s SPS Report describes these cross-cutting trade barriers and the 

efforts the U.S. Government has made to remove them. The leading cross-cutting SPS barriers 

arise in connection with: export certification requirements, agricultural biotechnology, BSE, AI, 

and maximum residue levels for pesticides. The individual country reports contained in section 

IV provide details on these barriers in specific markets.

Underlying these cross-cutting SPS trade barriers (and many of the other unwarranted SPS 

barriers described in section IV) is the disturbingly common failure by some U.S. trading 

partners to base their SPS measures on science, as the SPS Agreement requires. Unfortunately, 

some trading partners place other factors ahead of, or consider them together with, scientific

principles when establishing or applying certain SPS measures. Some trading partners apply 

SPS measures with an eye toward protecting domestic products, for example, or catering to 

perceived local consumer preferences. Such practices are reflected in the debates over SPS 

standards in relevant international fora, such as discussions in Codex regarding standards for 

ractopamine, an animal feed ingredient, where it is clear that certain trading partners consider 

factors other than science in imposing SPS measures.

The United States is committed to establishing SPS measures based strictly on science, 

consistent with both the letter and spirit of the SPS Agreement, and to pressing U.S. trading 

partners to do the same. 

A. Export Certification Requirements

Many countries require food imports to be accompanied by a written certification from the 

producer and exporting country setting out a variety of SPS-related assurances. These 

assurances may include, for example, declarations that the products have been produced under 

sanitary conditions and in disease-free areas. In recent years, however, many trading partners 

have begun requiring export certificates to include burdensome and often unnecessary 

“attestations” that, for example, may subject imports to unwarranted or overly burdensome 

testing requirements. 

This new type of export certification has created a significant and growing impediment to trade. 

The attestations required as part of these export certifications often appear to be scientifically 

unwarranted or to impose requirements that are inconsistent with the recommendations of the 

relevant international standard setting organizations (Codex, OIE, and IPPC). In other cases, the 

export certifications may call for attestations that are simply unnecessary. For example, certain 

importing countries require individual food shipments to be accompanied by an export 

certification that addresses the prevalence of certain animal or plant diseases in the exporting 

country when information on this subject is often freely available on websites that the exporting 

government or an international SPS standard setting body, such as the OIE, maintains.

The United States supports the work of international standard setting bodies in establishing 

guidelines for export certifications. Guidelines of this type, such as the Codex “Principles for 
20

Food Import and Export Inspection and Certification,” provide that certification requirements 

should be confined to eliciting information essential to meeting the objectives of the importing 

country’s food inspection and certification system. The Codex guidelines also call for importing 

countries to specify the reasons for requiring specific attestations to be included in export 

certifications and to apply their certification requirements in a non-discriminatory manner. The 

guidelines specify that the importing country may require, for example, access to production 

facilities and relevant documents of the exporting country. The OIE and IPPC have adopted 

similarly useful guidelines governing export certification requirements. 

Many countries, however, do not observe Codex, OIE, or IPPC guidelines when they impose 

export certification requirements. Moreover, U.S. exporters often first learn that a government 

has imposed new or different certification requirements, or has decided to implement them in a 

new way, only after the exporters find that their shipments have been detained at the port of 

entry. 

Following are examples of the sorts of unwarranted certification requirements certain U.S. 

trading partners impose that create unnecessary barriers to U.S. food exports: 

 Attestations and testing requirements that are not based on internationally accepted norms 

(e.g., attestations that shipments of certain foods are entirely free from Salmonella

bacteria or genetically engineered ingredients).

 Attestations that are not appropriate for purposes of addressing a legitimate human health 

or safety concern, such as a requirement to certify that shipments of pork and pork 

products are free from H1N1 virus, a pathogen that cannot be transmitted through food.

 Requirements for exporters to provide information regarding U.S. surveillance programs 

for various animal diseases when the importing government has ready access to this 

information through U.S. Government and international organization websites.

In February 2010, the United States and Australia sponsored an APEC export certification 

roundtable in Australia.4 Representatives of 20 of the 21 APEC Member Economies reached 

several conclusions and observations regarding the issuance and usage of official certificates in 

the APEC region, including avoiding redundancy in certifications and requiring attestations only 

when essential information is necessary to ensure food safety or fair practices in food trade. The 

representatives further discussed common challenges arising from certification requirements and 

options to address those challenges, the basis for requirements on export certificates, and 

common understandings and best practices in dealing with export certificates. 

In April 2012, the United States and Australia sponsored a follow up export certification 

workshop for APEC Member Economies in the United States. Representatives of more than 100 

APEC Member Economies and developing countries attended. The workshop built on the 

themes of the earlier roundtable, and the large attendance confirmed that export certification 

remains an important issue as well as a challenge for many countries. 

 

4

http://fscf-ptin.apec.org/docs/events/export-certification-roundtable/ECR_event_report.pdf
21

B. Biotechnology

Over the past 16 years, farmers around the world increasingly have planted crops developed 

through modern agricultural biotechnology or genetic engineering (GE) techniques. According 

to the International Service for the Acquisition of Agri-Biotech Applications, the number of 

countries growing agricultural biotechnology crops has increased from six in 1996 to 28 in 2012. 

Modern enhancements allow farmers to use fewer and safer pesticides while improving crop 

yield. Crops produced using agricultural biotechnology that are consumed in the United States 

for food, feed, or fiber include alfalfa, canola, corn, cotton, papaya, soybeans, squash, and sweet 

corn. USDA’s National Agricultural Statistics Service estimates that in 2012, 93 percent of 

soybean acreage, 88 percent of corn acreage, and 94 percent of cotton acreage in the United 

States were planted with biotech varieties. New GE crops will continue to be brought to market, 

leading to more acceptance of biotech crops on the one hand, and potentially more trade 

challenges on the other.

U.S. exports of biotech corn and soybeans, as well as other agricultural products that contain – or 

may contain – biotech-derived ingredients, face a multitude of trade barriers. The country-bycountry section of the SPS Report includes numerous examples of unwarranted import bans and 

restrictions currently being applied to U.S. biotech products. In addition, some trading partners 

impose mandatory labeling requirements on foods derived from biotech products that create 

technical barriers to trade by wrongly implying that these foods are unsafe.5 Some U.S. trading 

partners have continued to impose restrictions on these products even though repeated dietary 

risk assessments have shown no food safety concerns, and these biotech products have proven

safety records. 

The United States actively engages with trading partners to remove these unwarranted trade 

barriers as well as to share experiences related to agricultural biotechnology development, 

regulation, and trade. As part of these efforts, U.S. officials have helped shape the development 

of international standards related to the safety assessment of, and trade in, agricultural 

biotechnology products. For example, the United States contributed to the establishment of 

Codex Guideline for the Conduct of Food Safety Assessment of Foods Derived from 

Recombinant-DNA Plants (CODEX plant guideline) for assessing the safety of food from 

biotech crops. The United States has also supported the development of annexes to the Codex 

plant guidelines containing safety assessment guidelines for nutritionally enhanced biotech crops 

and for cases where small amounts of material from biotech plants authorized in the exporting 

country are found in food products in countries that have not authorized those products. 

Although the United States is not a party to the Cartagena Protocol on Biosafety, which governs 

transboundary movement of living modified organisms (another term for living genetically 

engineered plants and animals, including, for example, biotech corn, fish, and soybeans), the 

United States regularly participates in meetings of the Protocol Parties and related capacitybuilding efforts to promote science-based approaches involving international trade in these 

substances. The United States is also actively involved in regulatory and policy dialogues in 

APEC that address agricultural biotechnology. 

 

5 These labeling requirements are addressed in the TBT Report. 
22

C. Bovine Spongiform Encephalopathy 

BSE is a transmissible, fatal neuro-degenerative brain disease of cattle. BSE was first diagnosed 

in the United Kingdom (UK) in 1986. At its peak in 1992, there were 37,316 reported cases of 

BSE, 99.9 percent of which were in the UK. As of January 2013, the OIE indicated that in 2012, 

the number of cases had decreased to 12 cases globally, two of which were outside of Europe. 

The United States has had only four cattle test positive for BSE: an animal imported from 

Canada in 2003, a U.S.-born 12-year old animal in 2005, another 10-year old U.S.-born animal 

in 2006, and a U.S.-born 10-year old dairy cow in 2012. It is important to note that all three 

cases of BSE detected in the U.S. born animals were classified as the atypical form of the 

disease, a very rare form of the disease not generally associated with an animal consuming 

infected feed.

The OIE

The OIE is the international organization responsible for improving animal health worldwide. 

The OIE classifies the BSE risk status of cattle populations in particular countries on the basis of 

a risk assessment and other criteria. The OIE has established three risk categories: negligible 

risk, controlled risk, and undetermined risk, with different recommendations for the safe trade in 

live cattle, beef and beef products from countries in each category. In May 2007, based on a 

review of the potential release and exposure to the BSE agent, surveillance, awareness, and 

history of the disease in the United States, the OIE classified the United States as having a 

“controlled risk” status.

OIE guidelines specify that that live cattle and specific beef and beef products from a controlled 

risk country can be safely traded provided that certain slaughter and processing conditions are 

met, and appropriate “specified risk materials” (SRMs) are removed from the carcass before 

shipment. SRMs are those tissues where the BSE agent is known to accumulate and can 

therefore pose a human health risk. From a human health perspective, the removal of these 

tissues from cattle over the designated age is the single most significant measure to ensure the 

production of safe beef and beef products. With respect to BSE, all cattle tissues that the OIE 

has not designated as SRMs are safe for human consumption. 

U.S. BSE-Related Controls

The United States implemented an OIE-consistent feed ban in 1997, which prohibits feeding 

ruminants most mammalian protein. The U.S. feed ban was further strengthened in 2009 by 

prohibiting the use of the highest risk cattle tissues in all animal feed (not just ruminant feed). 

The presence of a ruminant-to-ruminant feed ban is the most important step a country can take to 

protect its cattle population from BSE exposure. In 2004, the United States implemented BSErelated measures in U.S. slaughterhouses and meat production establishments, the most 

important of which requires SRM removal. As a result of these interlocking measures, beef and 

beef products produced in the United States are safe for consumption. On March 9, 2012, USDA 

issued a proposed rule to further align its BSE regulations to the OIE guidelines. 
23

Foreign Trade Barriers to U.S. Exports of Beef and Beef Products

In December 2003, as a result of the first case of BSE detected in the United States, at least 100 

countries closed their markets to all U.S. beef and beef products, causing substantial economic 

harm to the U.S. beef industry, which at the time, exported approximately ten percent of its total 

production. In 2003, U.S. producers exported $3.86 billion (1.3 million metric tons) of beef and 

beef products. The following year, as a result of the widespread import ban, U.S. exports fell by 

79 percent, to $808 million. In 2011, the volume of U.S. exports of beef and beef products 

recovered, as U.S. beef and beef product exports reached 1.3 million metric tons. However, in 

2012 exports fell 12 percent to 1.1 million metric tons on tight supplies. Despite lower volumes, 

U.S. beef and beef products exports still reached a record $5.51 billion in 2012 due to increased

prices.

The increased value of sales is attributable to not only high prices but also favorable exchange 

rates and higher consumer demand for meat in countries with expanding economies. 

Nevertheless, U.S. beef exporters continue to face unwarranted and burdensome BSE-related 

import restrictions, including bans by some countries of all U.S. beef and beef products, selected 

bans on certain products (e.g., bone-in and ground beef), and restrictions on U.S. beef and beef 

products produced from animals over certain ages.

Moreover, the disparity in BSE-related measures in different markets represents a separate trade 

burden and undercuts the comparative advantage of U.S. exporters. This disparity not only 

burdens producers, who must alter production and packing processes based on the requirements 

of the specific export market, but USDA, which must maintain an export verification program to 

confirm that these alterations in production and packing processes meet the relevant 

requirements. Section IV of the SPS Report identifies several countries that continue either to 

ban U.S. beef entirely or impose other OIE-inconsistent restrictions on U.S. beef products. 

Some countries also maintain bans on other bovine and/or ruminant commodities (e.g., bovine 

gelatin; pet foods with bovine ingredients; bovine blood), as well as a large number of nonruminant commodities (e.g., rendered meals such as poultry or porcine meals and fishmeal; nonruminant blood products; and hydrolyzed proteins), based on unwarranted BSE-related concerns. 

The United States continues to engage with its trading partners to secure the removal of these 

bans. 

Restoring full access for U.S. beef and beef products based on science, the OIE guidelines, and 

the status of the United States as a controlled BSE risk country is a priority of the U.S. 

Government. The United States is continuing its efforts to negotiate bilateral protocols with 

trading partners to open their markets to U.S. beef. 

D. Avian Influenza 

AI is a virus that can infect wild birds and poultry. The OIE divides AI viral strains into two 

groups based on the ability of the particular virus to produce disease: LPAI and HPAI. LPAI 

naturally occurs in wild birds and can spread to domestic birds. In many cases, LPAI causes 

either no, or only minor, symptoms in infected birds. HPAI is more virulent than LPAI and can, 
24

accordingly, spread more easily. HPAI infections are often fatal in certain avian species, such as 

chickens and turkeys. 

U.S. AI-Related Controls

While there have been three minor outbreaks of HPAI in U.S. poultry since 1924, none of these 

outbreaks has caused significant human illness, and there is no evidence that HPAI currently 

exists in the United States. The success of the United States in preventing the establishment of 

HPAI can be attributed to various safeguards implemented by U.S. Federal and state 

governments. For example, Federal agencies work with states and the poultry industry to 

monitor U.S. bird populations in four key areas: live bird markets, commercial flocks, backyard 

flocks, and migratory bird populations. Inspectors conduct extensive testing in live bird markets 

and commercial flocks. In addition, any birds that show signs of illness are tested for AI. 

Finally, Federal officials and their state and industry partners have also worked to establish an 

effective and coordinated emergency response plan that would mitigate the impact of any 

outbreak of HPAI in the United States. U.S. HPAI control policies are consistent with the 

relevant science-based standards, guidelines, and recommendations issued by the OIE.

Foreign Trade Barriers to U.S. Exports of Poultry and Poultry Products

Despite these measures, many countries have imposed unwarranted import bans on U.S. poultry 

products based on professed concerns over AI, often citing isolated LPAI outbreaks. For 

example, China currently bans imports of poultry and poultry products from two U.S. states, 

Arkansas and Virginia. India maintains AI-related measures that serve to preclude the 

importation of poultry products from the entire United States. Many of these restrictions appear 

to be inconsistent with OIE guidelines, which provide recommendations on steps governments 

can take that help to ensure that poultry products can be safely traded in light of AI concerns. 

The United States remains highly concerned about unwarranted AI-related import bans. 

Removing such bans remains a high priority for the U.S. Government, and the United States has 

raised this issue with many trading partners, including China and India, in a wide range of fora. 

At U.S. Government prompting, U.S. trading partners have lifted 103 AI-related bans lifted since 

2008. Section IV of the SPS Report provides additional information on countries with 

unwarranted trade restrictions ostensibly related to AI.

E. Maximum Residue Levels for Pesticides

MRLs, known as tolerances in the United States, represent the maximum concentration of 

residues (generally expressed as parts per million or mg/kg of residue) permitted in or on food 

and animal feedstuffs after the application of approved pesticides. Governments around the 

world, including the United States, set MRLs to ensure food safety.

EPA establishes tolerances for pesticides in the United States. Under U.S. law, EPA must ensure 

a “reasonable certainty of no harm” to consumers of the food, including special consideration of 

infants and young children and other potentially vulnerable populations. All agricultural 

products produced in the United States or intended for consumption in the United States must 
25

comply with EPA tolerances. Inspectors from the FDA and USDA monitor both domestic and 

imported food and feedstuffs to ensure that tolerances are observed. 

Codex develops and maintains international standards for MRLs. The SPS Agreement 

encourages countries to base their MRLs on those that Codex has set. Nevertheless, it is not

uncommon for countries – including the United States – to set their own, stricter MRLs. When a 

government establishes an MRL that is more stringent than the relevant Codex standard, the 

government must do so consistently with Article 3 of the SPS Agreement, which calls for the 

government to provide either a scientific justification for that stricter standard or apply the 

standard in accordance with Article 5 of the SPS Agreement. 

Given the technical complexity of establishing MRLs, the United States works closely with key 

trading partners to share data and assist them in establishing their own science-based MRLs. For 

example, in 2011, the United States, Canada, and Mexico initiated a new NAFTA TWG on 

regional regulatory cooperation for pesticides. The TWG has focused on facilitating cost 

effective pesticide regulations in the three countries through collaboration and sharing, while 

achieving a high level of environmental and human health protection. This collaboration has 

been instrumental in reducing trade barriers and increasing access to safer means of pest control 

in all three markets.

As discussed in the country reports that follow, various countries have either set pesticide MRLs 

at unreasonably low thresholds, have failed to establish a MRL for certain pesticides that have 

established Codex or U.S. MRLs, or have a significant backlog of reviews for newer, safer 

pesticides. This situation has created significant trade barriers for U.S. horticultural exports. 

MRL enforcement policies in the EU, Japan, and Taiwan are of particular concern.

Increasingly, countries are working to establish their own positive lists of approved pesticides. 

The United States believes that the creation of positive pesticide MRL lists or systems that are 

based on the Codex standards are best suited to facilitate trade. However, positive list systems 

require a significant amount of data, staff training, and financial resources. In most cases, many 

years are required for a country to establish credible and transparent MRL regimes and 

enforcement programs. The United States works closely with its trading partners to jointly 

establish pesticide tolerances where appropriate. To ensure against trade disruptions while a 

pesticide is under evaluation, U.S. authorities often ask countries to adopt Codex MRLs on an 

interim basis until their permanent MRLs are established. If countries are unwilling to adopt the 

Codex MRLs or to defer to the scientifically based U.S. MRL in the interim, U.S. growers could 

be subject to onerous penalties and serious trade barriers for using pesticides that have been 

established as safe to use under prescribed conditions. 

27

IV. COUNTRY REPORTS 

This section sets out specific SPS concerns in reports on individual countries. The issues 

discussed in this section are the subject of U.S. Government engagement with U.S. stakeholders 

concerning unwarranted SPS barriers that U.S. exporters have encountered in these countries. 

The selection of barriers for discussion in this report reflects a considered process that is based 

on the U.S. Government’s understanding of those barriers. They raise significant trade concerns 

and, in some instances, give rise to questions concerning whether a trading partner is complying 

with its obligations under a trade agreement to which the United States is a party.6 

The U.S. goal is to work as vigorously and expeditiously as possible to resolve the concerns 

identified in this section. The tools the U.S. Government uses vary depending on the particular 

facts and circumstances. In many instances, the U.S. Government seeks to resolve specific 

concerns through dialogue with the pertinent trading partner – either bilaterally or through 

multilateral fora – and by working collaboratively to obtain changes that result in improved 

market access for U.S. exporters. In appropriate instances, dispute settlement under the WTO or 

in another relevant forum can be a tool to address specific concerns. 

In response to USTR’s outreach in compiling this report, U.S. stakeholders raised a number of 

new SPS concerns. Stakeholders should not view the absence of an issue in the report as an 

indication that USTR, and more broadly the U.S. Government, does not believe the matter raises 

significant concerns; it may simply reflect the fact that other Federal agencies are working to 

resolve the matter directly with their counterpart foreign ministries. It may also mean that USTR 

requires additional consultations or information to consider. For those issues, USTR will seek to 

compile additional information, including by following up with stakeholders, U.S. embassies, 

and other Federal agencies. 

The SPS Report provides more focused and structured reporting on country-specific issues than 

appeared in past years’ NTE Report, which may have included SPS issues that USTR has not 

included in this report. Where possible, each listing sets out the United States’ current 

understanding of the measure or practice, why it raises concerns, and how the United States is 

seeking to address it. The SPS Report is not simply a recounting of all outstanding issues that 

stakeholders have brought to USTR’s attention this year or in the past. For purposes of this 

report, USTR included measures that represent significant and unwarranted SPS barriers to U.S. 

exports and that the U.S. Government has devoted substantial resources to resolving. 

Regardless, the U.S. Government continues to gather information, and follow all concerns 

affecting U.S. stakeholders and pursue those issues as appropriate. 

Finally, much of the U.S. Government’s engagement in international and regional fora focuses 

on those trade-restrictive SPS measures that recur in a number of markets. Five of these 

measures are described in section III of this report. The U.S. Government adopts a strategic 

approach to measures of this kind, deploying resources where they can be most effective. In 

some instances, the U.S. Government elects to focus its efforts on a few countries where the 

 

6 Nothing in this report should be construed as a legal determination that a measure included in the report falls 

within the scope of any particular WTO Agreement (e.g., whether the measure is subject to the SPS Agreement as 

opposed to the TBT Agreement).
28

concern is the greatest. In other instances, the U.S. Government seeks to work with those 

countries with which the matter can be resolved most expeditiously or where engagement on the 

issue would produce maximum benefit for the United States and U.S. stakeholders. 

ARGENTINA

Food Safety

Live Cattle, Beef, and Beef Products

Argentina bans imports of all U.S. live cattle, beef, and beef products due to BSE‐related 

concerns following the detection of a BSE-positive animal in the United States in 2003. In 

November 2010, Argentina issued a final regulation regarding BSE and the importation of 

bovine products, but the new regulation did not correct many of the unwarranted restrictions in 

force previously, nor did it allow for the import of U.S. live cattle, beef, and beef products. The 

United States will continue to urge Argentina to open its market fully to U.S. beef and beef 

products based on science, the OIE guidelines, and the United States’ risk status.

See section III.C for an explanation of the BSE trade issue.

Animal Health

Pork

Currently, U.S. pork does not have access into Argentina. Argentina will not accept U.S. pork 

unless it first completes an assessment of the risk posed by U.S. pork. In October 2012, the 

United States provided the necessary information regarding U.S. swine health and surveillance of 

swine diseases to Argentine authorities to complete a risk assessment process. That process is 

pending. Moreover, Argentina has indicated to the United States that if approved for import,

U.S. pork must either be shipped frozen or tested for trichinosis. The United States does not 

consider these requirements for trichinosis to be necessary as U.S. producers maintain stringent 

biosecurity protocols that serve to limit the presence of trichinae in the United States to 

extremely low levels. The United States will continue to work with regulatory authorities in 

Argentina to resolve this trade concern.

Poultry

While U.S. exporters currently have access to Argentina’s market for certain poultry products, 

including day‐old chicks and hatching eggs, Argentina does not allow imports of fresh, frozen, 

and chilled poultry from the United States due to concerns over AI and Newcastle disease. 

Argentina indicated previously that it would accept cooked poultry products from the United 

States, but there is no agreement yet on what the U.S. sanitary certificate will state in light of 

Argentina's determination that the U.S. poultry inspection system is not “equivalent” to the 

Argentine system. The United States has expressed concerns regarding both Argentina’s poultry 

product limitations and failure thus far to grant equivalency to the United States. In technical 

discussions held in July 2012, Argentina stated that as soon as it publishes its revised poultry 
29

regulations, the United States should reaffirm its interest in obtaining market access for poultry 

products in order for Argentina to resume its evaluation of the U.S. request for access. U.S. 

officials will continue to engage on the issue.

See section III.D for an explanation of the AI trade issue.

Plant Health

Apples and Pears

Argentina currently bans imports of U.S. apples and pears due to concerns about the efficacy of 

post-harvest treatments for Erwinia amylovora (the bacterium that causes the disease fire blight). 

The United States has submitted technical information to Argentine plant health officials 

documenting that there is no evidence that mature, symptomless apple and pear fruit transmit fire 

blight. Argentina is currently reviewing the information and developing pest risk assessment

(PRA) for U.S. apples and pears. The United States continues to work with Argentine officials 

to open its market for U.S. apples and pears. 

AUSTRALIA

Food Safety 

Beef and Beef Products

Australia currently restricts the importation of bovine products from countries that have reported

one or more indigenous cases of BSE. On March 1, 2010, Australia modified its food safety 

import policies to allow imports of beef and beef products from countries that have had BSE 

cases. Under these requirements, a country interested in exporting beef and beef products to 

Australia must request Food Standards Australia New Zealand, a regional food safety agency, to 

conduct an individual country risk assessment. On March 18, 2010, the Australian Minister for 

Agriculture, Fisheries and Forestry announced that Biosecurity Australia must conduct a separate 

import risk analysis for each exporting country to address animal quarantine issues. The United 

States submitted a completed BSE‐related questionnaire in June 2010 and hosted a visit by an 

Australian official in July 2010 to discuss Australia’s BSE evaluation process. Biosecurity 

Australia has not yet concluded its risk assessment for U.S. beef and beef products. The United 

States will continue to urge Australia to open its market fully to U.S. beef and beef products 

based on science, the OIE guidelines, and the United States’ risk status.

See section III.C for an explanation of the BSE trade issue.

Animal Health

Pork

Access for U.S. pork to Australia is limited to frozen, boneless pork due to concerns about the 

introduction of porcine reproductive and respiratory syndrome (PRRS) and post‐weaning 
30

multisystemic wasting syndrome (PMWS). The United States has requested that Australia 

remove unwarranted PRRS and PMWS related restrictions to allow importation of all U.S. pork 

products. Citing these concerns, Australia also requires all solid waste from pork imports, 

regardless of whether the pork is cooked or uncooked, must be treated as a quarantine waste 

product. The new requirements have raised the costs of handling imported pork.

Poultry

Australia bars imports of fresh, frozen, and cooked turkey meat from the United States. In 2009, 

the United States requested Australia to prioritize granting market access for U.S. cooked turkey 

meat. In 2012 Australia initiated an evaluation of U.S. cooked turkey meat to assess the 

existence of a virus that causes Infectious Bursal Disease. The United States will work with 

Australia on any technical issues and will continue to press for progress on this issue. 

Plant Health

Apples

Australia currently prohibits the importation of apples from the United States based on concerns 

about fire blight, a contagious, bacterial disease which can infect apples, pears, and other 

rosaceous plants. For more than 15 years, the U.S. Government and the U.S. apple industry have 

engaged with Australian officials to demonstrate that U.S. mature, symptomless apples pose no 

risk of transmission of fire blight. In October 2009, Australia published a PRA for apples from 

the United States and identified three additional fungal pathogens of concern to Australian 

regulatory authorities. Research is currently being conducted by USDA to address Australia’s 

concern about the three fungal pathogens. The PRA also includes overly restrictive fire blight 

mitigation measures. If the PRA is approved as currently drafted, it will continue to prevent the 

commercial export of U.S. apples to Australia.

New Zealand requested a WTO panel in 2007 claiming that Australia’s measures regarding the

importation of New Zealand apples, including Australia’s mitigation measures for fire blight, 

were not based on a risk assessment in compliance with the WTO SPS Agreement. The United 

States was an active third party in support of New Zealand in the case. In August 2010, a WTO 

panel ruled in favor of New Zealand. In December 2010, the WTO Appellate Body largely 

upheld the panel’s findings. Apples from New Zealand are now authorized for importation into 

Australia. The United States continues to monitor Australia’s ongoing PRA process regarding 

U.S. apples in light of the WTO rulings and recommendations in this case.

Stone Fruit

Australia currently bans imports of U.S. stone fruit (peaches, nectarines, plums, and apricots) due 

to concerns about certain plant pests. In July 2010 Australia issued a final policy to allow market 

access for U.S. stone fruit from California, Idaho, Oregon and Washington with a systems 

approach for peach twig borer. However, in response to appeals from stakeholders, Australia

subsequently prohibited access until a mitigation could be found for spotted wing drosophila 

(SWD). As a result, U.S. stone fruit exporters will not be able to ship U.S. stone fruit to 
31

Australia until there is agreement on a mutually acceptable mitigation for SWD for stone 

fruit. The United States is engaged in an active dialogue with Australia on mitigation measures 

for SWD and is seeking to develop a preclearance program. This issue remains a top priority of 

the United States in its SPS engagement with Australia and is regularly addressed in bilateral 

discussions.

Table Grapes

The United States has been working with Australia for over 20 years to achieve access to the 

Australian market for California table grapes. Australia first opened its market under limited 

conditions in 2002. The United States has worked through the United States‐Australia FTA SPS 

Committee to remove other restrictions to expand access for U.S. table grapes in the Australian 

market. However, one Australian state, Western Australia, continues to deny market access for 

U.S. table grapes to its territory. Australia has indicated that it would complete a risk assessment 

to initiate the process to consider allowing California table grapes to gain access to Western 

Australia. The United States will continue discussions with Australia as it moves forward with 

this process.

BAHRAIN

Food Safety

Pork

Bahrain maintains a ban on U.S. pork exports from several U.S. states due to concerns regarding 

the H1N1 virus. Bahrain instituted the H1N1-related ban on U.S. pork even though there is no 

evidence to indicate that the virus can be conveyed to humans through the consumption of pork. 

The WTO, OIE, and FAO issued statements shortly after the H1N1 outbreak reminding countries 

that import bans on pork based on H1N1 concerns are unjustified in light of this fact.

BOLIVIA

Food Safety and Animal Health 

Live Cattle, Beef, and Beef Products

Bolivia continues to ban imports of all U.S. live cattle, beef, and beef products due to BSE‐

related concerns following the detection of a BSE-positive animal in the United States in 2003. 

In 2009, the United States submitted comments on a proposed Andean Community (CAN) risk 

assessment, which stipulated that only live animals under 24 months of age could be imported. 

A CAN resolution, published on April 13, 2010, stipulated that CAN Member States could 

establish their own requirements for imports of U.S. live cattle in accordance with the CAN risk 

assessment. The United States will continue to urge Bolivia to open its market fully to U.S. beef 

and beef products based on science, the OIE guidelines, and the United States’ risk status.

See section III.C for an explanation of the BSE trade issue.
32

BOSNIA AND HERZEGOVINA

Agricultural Biotechnology

Since Bosnia and Herzegovina (BiH) passed the Food Law of November 2004, genetically 

engineered (GE) products have not been permitted into BiH. A biosafety law passed in 2009 

permitting the importation of licensed GE products. However, it took more than three years for 

BiH’s Council of Ministers to adopt five implementing rules that establish procedures to import 

and market agricultural biotechnology products. BiH has not issued the regulation that describes

the process for approving cultivation of agricultural biotechnology products. BiH is a potential 

candidate for EU accession, and these regulations are similar to EU regulations. BiH’s antibiotechnology position has impeded U.S. commercial exports, and the BiH government has 

opposed import of biotech corn and soybean food assistance shipments. 

U.S. embassies in Belgrade, Sarajevo and Zagreb organized an agricultural biotechnology 

outreach program in Serbia, Croatia, and BiH in 2012. The goal was to advance U.S. 

agricultural biotechnology policy goals and promote acceptance of agricultural biotechnology in 

these countries. Using the GE HoneySweet plum, which is resistant to the plum pox, as an 

example of a crop from which these countries would benefit, the speakers countered 

misconceptions about agricultural biotechnology, fostered positive public opinions about 

agricultural biotechnology products, and shared advice for developing a more conducive policy 

environment for agricultural biotechnology products. 

BRAZIL

Food Safety 

Live Cattle, Beef, and Beef Products

Brazil bans imports of U.S. live cattle, beef, and beef products following the detection of a BSEpositive animal in the United States in 2003. In late 2008, Brazil promulgated a draft regulation 

that establishes sanitary requirements for the importation of ruminants and ruminant products 

from countries affected by BSE. Brazil continues to state that it has not completed its review of 

technical information provided by the United States. During high level discussions, Brazil 

indicated it was not willing to conform its import restriction to the OIE guidelines. U.S. officials 

pressed Brazilian officials for resolution of this matter on a number of occasions in 2012. The 

United States will continue to urge Brazil to open its market fully to U.S. beef and beef products 

based on science, the OIE guidelines, and the United States’ risk status.

See section III.C for an explanation of the BSE trade issue.

Pork

Brazil only allows imports of U.S. pork from plants that its inspectors have individually 

inspected and approved. This approach is burdensome on the industry and significantly limits 

the market access of companies willing and able to export to Brazil. Brazil has not explained 
33

why a plant-by-plant inspection system is required rather than the systems‐based approach 

recommended by the WTO and used in FSIS’ ongoing system equivalence process. The United 

States continues to discuss this issue with Brazil.

Brazil also restricts imports of pork and pork products from the United States, citing the risk of 

trichinosis. Currently, fresh U.S. pork can be imported into Brazil only if the product is tested to 

be free of trichinae. These requirements are unwarranted as U.S. pork producers maintain 

stringent biosecurity protocols that serve to limit the incidence of trichinosis in the United States 

to extremely low levels.

In May 2009, the United States proposed a voluntary certification process, which Brazil rejected 

in October 2009. In August 2010, the United States held technical discussions with Brazil on 

U.S. risk management techniques for trichinosis. In October 2010, Brazil indicated that it was 

prepared to work with the United States on this issue. U.S. officials engaged on the matter with 

their Brazilian counterparts on a number of occasions in 2012. The United States will continue 

to engage Brazilian authorities to address these restrictions.

Plant Health

Planting Seeds

In December 2010, Brazil’s Ministry of Agriculture, Livestock and Food Supply (MAPA) 

published Normative Instruction 36 (Norma 36), a regulation establishing burdensome and 

extensive treatments and seed testing requirements for the importation of 118 seed species into 

Brazil. Following coordinated engagement by the U.S. Government, the U.S. seed industry, and 

other trading partners of Brazil, MAPA amended Norma 36 in February 2011, allowing for 

inspection of seed fields instead of laboratory testing as originally described in the regulation. 

MAPA has postponed the implementation of additional declarations, which were of concern to 

trading partners, while MAPA developed the pest list for each species of seed. On May 10, 

2012, MAPA notified the WTO of the modified regulation with a list of pests associated with the 

regulated seeds (now reduced to 69 seed species). Brazil provided for a comment period of 60 

days. APHIS submitted comments and concerns on July 6, 2012. On October 30, 2012, MAPA 

published the Normative Instruction 24-2012, which postponed the enforcement of the additional 

declarations established by Norma 36 for another year, until December 1, 2013, to provide 

MAPA time to finish reviewing the comments it received. MAPA states that pest risk 

assessments might be required to address comments received. The United States will continue to 

engage Brazil on the issue.

CHILE

Food Safety

Pork

Chile requires pork produced in the United States to be shipped frozen or tested for trichinosis. 

Chile’s requirements constitute a significant impediment to U.S. fresh and chilled pork exports to 
34

Chile. The United States does not consider these requirements to be necessary given that U.S. 

producers maintain stringent biosecurity protocols that serve to limit the appearance of trichinae 

in the United States to extremely low levels. As an alternative, the United States proposed less 

trade restrictive risk mitigation measures to assure Chile that U.S. pork exports do not contain 

trichinae. The United States has raised this issue on the margins of the Trans-Pacific Partnership 

(TPP) SPS negotiations on numerous occasions and will continue to work with Chile to resolve 

this trade concern.

Live Cattle

Chile bans imports of U.S. live cattle following the detection of a BSE-positive animal in the 

United States in 2003, despite its long standing commitment to adhere fully to OIE guidelines. 

The United States will continue to urge Chile to open its market fully to U.S. live cattle based on 

science, the OIE guidelines, and the United States’ risk status.

See section III.C for an explanation of the BSE trade issue.

Salmonid Eggs

On July 14, 2010, Chile’s Ministry of Fisheries, SERNAPESCA, suspended imports of salmonid 

species from all countries, including the United States, due to Chile’s revised import regulations 

for aquatic animals, including salmonid eggs. Under the new regulations, U.S. industry can no 

longer export salmonid eggs into Chile under any conditions until SERNAPESCA completes a 

risk analysis of aquatic animal imports and an on-site audit of APHIS’ oversight of aquatic 

animal exports and U.S. salmonid egg production sites. An audit was conducted in December 

2011 on USDA’s oversight of U.S. salmonid egg production sites in Washington and Maine. 

The United States had understood that the audit of Washington State was successful and that 

trade from that state could resume by the end of summer 2012. However, SERNAPESCA later 

informed USDA that additional information would be required to document the strength of the 

national surveillance program. The United States is still awaiting the results of the Maine audit. 

This issue has been raised on the margins of the TPP SPS negotiations on numerous occasions. 

While Chile has expressed an interest in working with the United States to resolve this issue

through continuing review of U.S. and state surveillance programs, it has also recommended that 

the States of Washington and Maine apply for equivalence determinations. However, such 

determinations would be time consuming and appear to be unwarranted given that Chile has yet 

to identify a specific health concern. 

CHINA

Agricultural Biotechnology

Under Chinese regulations, an agricultural biotechnology product developed in a foreign country 

must first be approved for use in that country before Chinese authorities will begin to consider 

approving the product for use in China. The United States is concerned that such a practice

creates significant and unwarranted delays in China’s approval of agricultural biotechnology 
35

products, which could result in substantial disruptions in exports of certain U.S. agricultural 

products. 

See section III.B for an explanation of the agricultural biotechnology trade issue.

Food Safety 

Ractopamine

China bans imports of pork containing any residue of ractopamine, a feed additive that promotes 

feed efficiency in pigs and certain other livestock, despite U.S. government approval, 

establishment of a Codex standard, and scientific evidence indicating that ractopamine can be 

used safely. China has enforced this ban by barring imports from several U.S. facilities that 

previously shipped pork to China that contained trace amounts of ractopamine at concentrations 

below the U.S. MRL and the Codex MRL. The United States strongly disagrees with China’s 

assertions that there are serious concerns about the safety of ractopamine. China has not 

responded to repeated U.S. Government requests for risk assessments that support such concerns.

During meetings in conjunction with the U.S.-China Strategic and Economic Dialogue in 2011, 

U.S. officials asked China to adopt an interim MRL while awaiting Codex’s final adoption of an 

MRL. China’s Ministry of Agriculture (MOA) declined this request, claiming that China needs 

to await a final decision by Codex. In July 2012, Codex adopted MRLs for ractopamine use in 

pigs and cattle. The United States continues to press China on this issue in bilateral and 

multilateral fora.

Live Cattle, Beef, and Beef Products

In December 2003, China imposed a ban on U.S. live cattle, beef, and beef products due to the 

detection of a BSE-positive animal in the United States in 2003. Since that time, the United 

States has repeatedly provided China with extensive technical information on all aspects of U.S. 

BSE‐related surveillance and mitigation measures, which the OIE has recognized as effective 

and appropriate, for both food safety and animal health.

At the end of June 2006, after three inconclusive rounds of negotiations, China’s food safety 

regulators unilaterally announced a limited market opening, restricted to the entry of U.S. 

deboned beef from animals 30 months of age or less. One month later, however, China followed 

that announcement with a more detailed measure setting out 22 conditions for entry, many of 

which were unrelated to the risk posed by BSE. The cumulative effect of these restrictions is 

that the market remains closed to U.S. beef and beef products.

In March 2010, USTR and USDA senior officials met with their Chinese counterparts in Beijing 

to restart beef market access negotiations based on full consistency with the OIE guidelines on 

BSE. Bilateral discussions on U.S. beef exports continued throughout 2010, including high-level 

meetings between USDA and USTR officials and their Chinese counterparts. During the first 

two weeks of January 2011, senior officials from USTR and USDA led a team of experts from 

both agencies and FDA for a meeting with their counterparts in Beijing. The talks were 
36

beneficial both in assisting the two sides in understanding each other’s positions on the key 

issues as well as in narrowing differences in a number of areas. 

Both sides continued to engage at senior and technical levels throughout 2011 and 2012, 

including a visit by U.S. regulators to meet with their Chinese counterparts in December 2012, 

exchanges between working level officials, and discussions of the issue during the meetings of 

the Joint Commission for Commerce and Trade (JCCT). The United States will continue to urge 

China to open its market fully to U.S. beef and beef products based on science, the OIE 

guidelines, and the United States’ risk status.

See section III.C for an explanation of the BSE trade issue.

Meat and Poultry

China has imposed a zero tolerance limit for the presence of Salmonella, Listeria, and other 

pathogens in imported raw meat and poultry. Such a standard is unwarranted, because it is 

generally accepted by food safety experts and scientists that pathogens cannot be entirely 

eliminated from raw meat and poultry, and that proper storage, handling, and cooking of raw 

meat and poultry reduce significantly the risk of a number of food‐borne diseases caused by 

these microbes. In 2009, China’s regulatory authorities assured the United States that they were 

in the process of revising China’s standards for Salmonella in poultry, but they have yet to do so. 

The United States continues to engage China on this issue.

Processed Meat Products

In May 2012, U.S. processed meat manufacturers informed USDA that China’s Customs, 

Inspection, and Quarantine officials had detained imports of processed meat products (sausages 

and rendered chicken fat) without notifying U.S. authorities of any specific concerns. In August 

2012, China’s General Administration of Quality Supervision, Inspection and Quarantine 

(AQSIQ) notified USDA that the equivalence agreement under which U.S. producers had been 

shipping processed and unprocessed meat products to China applied only to unprocessed meat 

and not to processed meat, and U.S. producers would now be required to register with AQSIQ 

before shipping processed meat to China, allegedly to address unspecified food safety issues. 

The United States does not consider the products in question to pose food safety concerns, but 

China continues to detain processed meat products if they are shipped without registration. Due 

to the uncertainty of regulations in China, U.S. producers sharply reduced processed meat 

exports and are looking for clear guidance as to China’s import requirements. The United States 

will continue to seek resolution of this issue with China. 

Animal Health

Animal Feed

China’s AQSIQ published in 2009 Decree No. 118, which is a measure regulating animal feed 

and feed additives, and indicated that it would begin verifying compliance with the measure in 
37

early 2011. Such activities include: requiring foreign regulatory agencies to maintain a list of 

facilities approved to export feed products; requiring plant-by-plant audits; and requiring 

manufacturers to provide proprietary information to AQSIQ, including photographs of 

processing facilities. Many of the requirements appear to be unwarranted.

In 2011, the United States and China agreed that these verification requirements would not be 

applied until June 30, 2012, to give both countries the opportunity to discuss this issue further. 

As a result of those discussions, 121 U.S. animal feed facilities under the authority of APHIS 

were approved to export animal feed to China as of August 2012. To address China’s new 

requirements for fishmeal under Decree No. 118, in 2012, the National Oceanic and Atmospheric 

Administration (NOAA) negotiated new certification requirements for fishmeal with China to 

retain market access for this commodity. Notwithstanding these negotiations, industry estimates 

that U.S. animal feed exports to China experienced a significant decline as a result of Decree No. 

118.

Bovine Products

China has banned U.S. exports of protein‐free tallow due to BSE‐related concerns following the 

detection of a BSE-positive animal in the United States in 2003. China’s protein‐free 

requirement is difficult to comply with and appears inconsistent with the OIE guidelines, which 

allow for trade in tallow with maximum level of insoluble impurities of 0.15 percent in weight, 

regardless of the BSE status of the exporting country. In August 2010, Chinese officials 

announced that China was prepared to open its market to U.S.‐origin tallow. However, since that 

time the United States and China have not yet reached agreement on the entry and certification 

requirements.

See section III.C for an explanation of the BSE trade issue.

Poultry

At the December 2012 JCCT meeting, China announced that it would lift its AI‐related ban on 

poultry from Minnesota, although it continues to ban poultry and poultry products from Arkansas 

and Virginia (or transshipped through those states) based on reported detections of LPAI in those 

states. China’s current AI‐related import bans raise concerns that they are not science‐based or 

consistent with OIE guidelines.

During bilateral meetings in 2012, including JCCT working group meetings, the United States 

and China agreed to hold further technical talks to address China’s bans on imports from the 

remaining states. 

See section III.D for an explanation of the AI trade issue.
38

Plant Health

Apples

Since 1995 China has only allowed imports of two varieties of U.S.‐origin apples from three 

states (Idaho, Oregon, and Washington). Other varieties of apples have not been authorized due 

to pest-related concerns especially with regard to the bacterial disease fire blight. In March 

2000, U.S. officials requested AQSIQ to allow imports of additional apple varieties from those 

states and to permit imports of apples from a fourth state, California. As part of this request, 

U.S. authorities provided China with a substantial amount of peer‐reviewed scientific 

information indicating that there is no evidence that mature, symptomless commercial apples can 

transmit fire blight. However, China continues to cite concerns about fire blight and several 

fungal pathogens as a reason for not approving additional apple varieties from the three approved 

states. Additionally, in 2012 China suspended imports of apples from Washington due to 

concerns regarding three fungal pathogens.

Discussions are ongoing regarding the development of a mutually acceptable pest list to support 

the U.S. access request for additional apple varieties and to address China’s quarantine concerns 

about apples from Washington.

Potatoes

China has not permitted imports of U.S.‐origin table stock potatoes based on concerns over 

various plant pests and diseases. In 2000, the United States officially requested China to allow 

imports of fresh potatoes from Idaho, Oregon, and Washington. The United States has been 

waiting for AQSIQ to share the results of its risk assessment. The United States continues to 

engage China on this issue in a variety of bilateral and multilateral fora, including in the WTO 

SPS Committee.

Strawberries

The United States is seeking to establish permanent market access to China for California 

strawberries. In 2008, AQSIQ allowed California strawberries to be imported for the Olympic 

and Paralympic Games in Beijing. At that time, Chinese authorities acknowledged that 

California strawberries were safe. However, USDA has since sought permanent access, and 

while China has not provided any scientific justifications for its delay, a decision on permanent 

access has not been granted.

COLOMBIA

Food Safety

Poultry

Colombia is in the process of establishing a new national policy for Salmonella, although the 

specifics of that new policy remain unclear. In April 2012, the United States and Colombia 
39

established through an exchange of letters a protocol to address Salmonella regulatory concerns. 

The understanding states that Colombia recognizes the U.S. monitoring and control procedures 

for Salmonella and that Colombia will not reject poultry meat or poultry products for 

Salmonella-related reasons provided the shipment is accompanied by agreed-upon FSIS 

certification. As part of the letter exchange, the two countries further agreed to cooperate on the 

development of Colombia’s national policy on Salmonella, and the United States continues to 

work with Colombia in addressing this matter. 

Animal Health

Live Cattle

Colombia continues to ban U.S. live cattle due to BSE‐related concerns following the detection 

of a BSE-positive animal in the United States in 2003. In 2009, the United States submitted 

comments to CAN on a proposed risk assessment, which stipulated that only live animals less 

than 24 months of age could be imported. A CAN resolution, published April 13, 2010, 

stipulated that CAN Member States could establish their own requirements for imports of U.S. 

live cattle in accordance with the CAN risk assessment.

In June 2010, Colombia nominally allowed live cattle imports from the United States, but at the 

same time imposed such restrictive requirements that they effectively prevented any such 

imports. In January 2011, USDA proposed a protocol to Colombia that covers trade in live cattle 

as well as provided further comments to Colombia regarding its requirements. The issue was 

discussed at the first meeting of the United States-Colombia Trade Promotion Agreement 

(CTPA) SPS Committee in November 2012. The United States will continue to urge Columbia 

to open its market fully to cattle, U.S. beef and beef products based on science, the OIE 

guidelines, and the United States’ risk status.

See section III.C for an explanation of the BSE trade issue.

Pork

Colombia requires pork produced in the United States to be shipped frozen or tested for 

trichinosis. Colombia’s requirements constitute a significant impediment to U.S. fresh and 

chilled pork exports to Colombia. The United States does not consider these requirements to be 

necessary as U.S. producers maintain stringent biosecurity protocols that serve to limit the 

appearance of trichinae in the United States to extremely low levels. U.S. and Colombian 

regulatory authorities reached a framework understanding concerning access to Colombia for 

fresh/chilled pork in May 2012 and have worked subsequently to finalize the associated details. 

The status of this work was reviewed at the CTPA SPS Committee meeting held in November 

2012, and U.S. officials are working to address the remaining issues.
40

CROATIA

Agricultural Biotechnology

Croatia prohibits the import of all food products that contain even trace amounts of food 

products derived from modern agricultural biotechnology. This restriction makes it extremely 

burdensome and expensive to export U.S. food products to Croatia. U.S. embassies in Belgrade, 

Sarajevo, and Zagreb organized an agricultural biotechnology outreach program in Serbia, 

Croatia, and Bosnia and Herzegovina in 2012. The goal was to advance U.S. agricultural 

biotechnology policy goals and promote acceptance of agricultural biotechnology in these 

countries. Using the GE HoneySweet plum, which is resistant to the plum pox, as an example of 

a crop from which these countries would benefit, the speakers countered misconceptions about 

agricultural biotechnology, fostered positive public opinions about GE products, and shared 

advice for developing a more conducive policy environment for GE products 

See section III.B for an explanation of the agricultural biotechnology trade issue.

DOMINICAN REPUBLIC

Food Safety

Beef and Beef Products

The Dominican Republic bans imports of U.S. beef and beef products from cattle 30 months of 

age and over due to concerns about BSE. On a number of occasions during 2012, USDA 

officials raised this issue with the Dominican Republic’s Veterinary Services division. The 

United States will continue to urge the Dominican Republic to open its market fully to U.S. beef 

and beef products based on science, the OIE guidelines, and the United States’ risk status.

See section III.C for an explanation of the BSE trade issue.

ECUADOR

Food Safety

Live Cattle, Beef, and Beef Products

Ecuador continues to ban imports of all U.S. live cattle, beef, and beef products following the 

detection of a BSE-positive animal in the United States in 2003. Ecuador and the other three 

CAN Member States (Bolivia, Colombia, and Peru) maintained that CAN rules prevented them 

from lifting their BSE‐related restrictions.

In 2009, the United States submitted comments on a proposed CAN risk assessment, which 

stipulated that only live animals under 24 months of age could be imported. A CAN Resolution, 

published on April 13, 2010, stipulated that CAN Member States could establish their own 

requirements for imports of U.S. live cattle in accordance with the CAN risk assessment. On 
41

August 30, 2010, Ecuador published Regulation 20137, which proposed certain import 

requirements related to several animal diseases including BSE, Brucellosis, and foot-and-mouth 

disease (FMD) for U.S. live cattle, beef, and beef products. The United States will continue to 

urge Ecuador to open its market fully to U.S. beef and beef products based on science, the OIE 

guidelines, and the United States’ risk status.

See section III.C for an explanation of the BSE trade issue.

EGYPT

Food Safety

Egypt’s Ministry of Industry and Foreign Trade Ministerial Decree 266 (2011) adopted the 

European Economic Commission (EEC) Regulation 2377 (1990), which sets MRLs for 

veterinary medicinal products, including animal growth promotants, in foodstuffs of animal 

origin. Egypt’s implementation of the EU’s ban on utilization of animal growth promotants 

threatens to jeopardize the $217 million market for U.S. beef and variety meats. The United 

States has requested that Egypt rescind this decree, and will be engaging at a technical level with 

Egypt on this issue. 

Plant Health

Seed Potatoes

Egypt is one of the last of the world’s largest seed potato importers that bans imports of most 

varieties of U.S. seed potatoes due to phytosanitary concerns regarding Ralstonia (brown rot). 

The United States considers that the U.S. seed certification process effectively mitigates 

Ralstonia, and USDA has informed Egypt of that. Nevertheless, Egypt requires registered 

varieties to undergo mandatory field trials for three seasons, as well as compliance with a host of 

other plant quarantine conditions. The United States has urged Egypt to develop a mutually 

agreeable work plan for conducting the field trials to address their concerns and facilitate 

commercial shipments of U.S. seed potatoes to Egypt. 

Wheat

In 2010, Egypt's Central Administration for Plant Quarantine (CAPQ) of the Ministry of 

Agriculture and Land Reclamation (MALR) imposed a zero tolerance policy for the presence of 

Ambrosia (ragweed) in wheat imports, although one or more varieties of Ambrosia are present in 

all major wheat exporting countries, including in Egypt. CAPQ and the General Authority for 

Supply of Commodities, Egypt’s state wheat buyer, later modified the restriction to provide that 

all wheat imports must be “free of Ambrosia seeds.” No other country that imports U.S. wheat 

imposes a restriction of this kind. If Ambrosia seeds are detected in a shipment, CAPQ permits 

the wheat cargos to be discharged and cleaned. However, exporters and importers face the risk 

that shipments could be rejected because of this restriction. The U.S. Government and U.S. 

industry are working together to convince CAPQ to remove this unnecessary restriction.
42

Cotton

On March 18, 2012, MALR signed Decree 438 lifting the import ban on cotton from all origins 

that was originally imposed on October 25, 2011, by Decree 1864. However, the March decree 

was abrogated on technicalities by a ruling in Administrative Court, and the Egyptian 

government continues to only permit cotton imports for utilization in the country’s free trade 

zones as mandated in Decree 652 of November 22, 2011. In September 2012, CAPQ announced 

that Egypt would require inspection by CAPQ personnel prior to shipment. CAPQ informed 

USDA on November 13 that it is delaying the implementation of its decision due to the lack of 

availability of inspectors, but the requirement remains in force. The United States will continue 

to engage with Egypt to remove these burdensome requirements and restore U.S. cotton exports. 

EL SALVADOR

Plant Health

Rice

El Salvador has begun enforcing a regulation for rough rice from the United States that requests 

an additional declaration in the phytosanitary permit stating that shipments are free of weed 

seeds. The United States is working to resolve this barrier. 

ETHIOPIA

Agricultural Biotechnology

In September 2009, Ethiopia established a biosafety law that may impose unduly burdensome 

documentation and testing requirements for agricultural biotechnology products. Ethiopia has 

since issued implementing regulations, which restrict the use of U.S. agricultural commodities 

derived from biotech. The restrictions include but are not limited to: requiring the applicant to 

use a qualified expert to undertake the risk assessment for each transaction; prohibiting the use of 

“may contain modified organisms” language for traded living modified organisms in shipments 

intended for direct use as food or feed, or for processing; and requiring a signed statement for all 

imports by the head of the competent national authority of the country of export to the effect that 

the competent national authority takes full responsibility for the completeness and accuracy of 

the information provided in the import application. U.S. officials continue to engage Ethiopian 

officials to express concerns about this legislation and to seek clarification regarding 

implementation procedures.

See section III.B for an explanation of the agricultural biotechnology trade issue.
43

EUROPEAN UNION

Agricultural Biotechnology

European Union (EU) measures governing the importation and use of GE products have resulted 

in substantial barriers to trade. Restrictions on GE products can result in import prohibitions on 

U.S.‐produced commodities and foods, as well as prohibitions on the cultivation of GE seeds. 

EU policies restrict the importation and use of U.S. agricultural commodities derived from 

agricultural biotechnology. These restrictions include but are not limited to:

 Delays in approvals of new GE traits despite positive assessments by the European Food 

Safety Authority (EFSA);

 Imposing commercially infeasible requirements on GE content in food products under 

EU Traceability and Labeling (T&L) regulations;

 Prohibitions on importation of GE commodities by certain EU Member States;

 Difficulties in applying for registration of GE commodities in the National Seed Catalog;

and

 Application of unnecessary and burdensome coexistence requirements to planting of GE 

crops alongside non-GE crops by certain EU Member States. 

Under EU law, each GE trait, as well as each combination of traits, must be approved for a 

specific use before an agricultural product containing or produced from that trait or traits is 

allowed to be imported or used in the EU. The EU approval system has two basic steps: an 

initial scientific assessment, followed by a “comitology” process, which involves interactions 

between the European Commission and the EU Member States. Even when the EU approves a 

particular GE product, EU biotechnology legislation provides that individual Member States may 

invoke their own bans under a so‐called “safeguard clause.”

EFSA undertakes the scientific assessment. EFSA assessments of GE products generally take 

longer than comparable scientific assessments in the United States and other countries. 

However, EFSA generally reaches the same scientific conclusion for a specific GE product as 

scientific authorities in the United States and other countries. EFSA has never concluded that a 

GE variety in U.S. commercial production is unsafe. If EFSA concludes that the GE product is 

as safe as its conventional counterpart, the application proceeds to the comitology process. In 

2012, the European Commission proposed to change its regulations governing the EFSA 

evaluation to specify the data and testing necessary for all applications. The Commission 

finalized this proposal in February 2013 despite U.S. government comments questioning the 

scientific basis for the regulation. The regulation requires certain tests, including feeding studies, 

irrespective of whether they are scientifically necessary and appropriate to the application and go 

beyond or conflict with the approach to safety assessment as outlined in the Codex plant 
44

guideline. The new regulation risks further increasing the length of time EFSA needs to evaluate 

applications.

Under the comitology process, the European Commission first prepares an approval measure 

based on the scientific assessment. The Commission then submits the measure to a regulatory 

committee comprised of representatives from each of the 27 EU Member States. Not once in 

over 12 years has an EU regulatory committee accepted a proposed measure to approve a new 

GE product. Instead, EU regulatory committees have always issued a “no‐decision.” This non‐

result leads to further, time‐consuming procedures in the comitology process. The failure of EU 

regulatory committees to make decisions in accordance with the EU’s own scientific opinions 

has resulted in substantial delays in the approval of GE products.

In response to these types of problems, in May 2003, the United States – joined by Canada and 

Argentina – initiated a WTO challenge to the EU’s operation of its biotech approval system. In 

September 2006, a WTO dispute settlement panel upheld the U.S. claims. The panel found: (1) 

that the EU had adopted a de facto, across‐the‐board moratorium on the final approval of GE 

products and that the moratorium resulted in undue delays in violation of the EU’s obligations 

under the SPS Agreement; (2) that the EU had violated its SPS obligations to consider biotech 

applications without undue delay with respect to 24 specific GE product applications; and (3) 

that EU Member State bans on products approved in the EU prior to the moratorium were not 

supported by scientific evidence and were thus inconsistent with the EU’s SPS obligations.

The WTO Dispute Settlement Body adopted the report in November 2006, and the EU’s

“reasonable period of time” for compliance expired in January 2008. At that time, the United 

States submitted a request to the WTO for authority to suspend trade concessions. Under an 

agreement with the EU, however, proceedings on the U.S. request were suspended to provide the 

EU an opportunity to demonstrate meaningful progress on the approval of GE products. The 

United States continues to engage the European Commission in an effort to normalize trade in 

GE products.

At the end of 2012, 72 GE product applications (for import, renewal, and cultivation) were 

pending approval in the EU system. The EU approved only six GE products in 2012 (5 new 

products and one renewal of a previously approved product), with an average processing time of 

40 months. In addition, the EU has not approved for cultivation a single GE product of 

commercial significance to the United States in over 12 years.

EU delays in GE product approvals can block trade not only for the products subject to the 

delays, but also for approved varieties. Under the EU’s implementation of its biotechnology 

legislation, the presence in U.S. grain or oilseed shipments of trace amounts of GE crops that are 

legally grown in the United States, but not yet approved in the EU, can make U.S. crops 

unmarketable in the EU. In July 2011, the EU implemented a “technical solution” to address the 

presence of trace amounts of EU‐unapproved GE products in import shipments. The new rules 

only cover shipments of imported animal feed (thus excluding food for human consumption) and 

provide an impractically low threshold level. The Commission has announced that it will assess 

the need to include food within the scope of the rules, but has yet to issue any proposals. 
45

The EU has taken steps to address some but not all of the Member State bans that the WTO 

panel found to be inconsistent with the EU’s WTO obligations. Member States have continued 

to adopt new bans on products approved at the EU‐level, however. In most cases, the 

Commission asks EFSA to issue an opinion on whether the Member State ban can be justified on 

a scientific basis. EFSA consistently has determined that the Member State bans lack a scientific 

justification. In several instances, the Commission has proceeded to draft a measure, in 

accordance with the EFSA scientific opinion, that would require a Member State to lift an 

unjustified ban. However, the EU regulatory committees have blocked each such measure, just 

as the regulatory committees have failed to approve new GE varieties.

In July 2010, the Commission presented a package of proposals that would expand the reasons 

that a Member State could use to justify bans on cultivating GE crops in its territory. The 

package includes a new recommendation on the co‐existence of GE crops with conventional and 

organic crops and a proposal amending the governing legislation. The recommendation on co‐

existence took immediate effect. It provides Member States greater flexibility when developing 

national co‐existence measures and allows them to define GE‐crop‐free areas. The legislative 

proposal, which is still under consideration and is subject to “co‐decision” by the Member States 

and the European Parliament, would allow Member States to restrict or prohibit the cultivation of 

GE crops in all or part of their territory. The proposal does not require Member States to base 

any such restrictions on safety concerns, but allows them to take into account other societal 

concerns.

The EU continues to restrict imports of U.S. long grain rice following the discovery in a 2006 

shipment of the genetically engineered Liberty Link 601 (LL601) trait. Since 2006, the U.S. rice 

industry has effectively removed the trait through rigorous seed testing under an industry-wide 

protocol (called “the Seed Plan”), but European rice importers and retailers have largely refused 

to purchase U.S. rice out of fear of the legal and commercial consequences should a detection of 

the LL601 trait occur again.

See section III.B for an explanation of the agricultural biotechnology trade issue.

Food Safety

Beef and Beef Products – Hormones

In May 2009, the United States signed a memorandum of understanding (MOU) with the EU to 

resolve on a provisional basis their WTO dispute over U.S. beef raised with growth‐promoting 

hormones. The MOU, which took effect in August 2009, provides additional duty‐free access to 

the EU market for high-quality beef produced from cattle that have not been raised with growth‐

promoting hormones – 20,000 metric tons (MT) in each of the first three years, increasing to 

45,000 MT beginning in the fourth year. The EU increased the quota to 48, 200 MT beginning 

in August 2012. 

The United States will continue to monitor EU implementation of the MOU, as well as other 

developments affecting access to the EU market for U.S. beef products. 
46

Beef – Pathogen Reduction Treatments

The EU’s failure to approve pathogen reduction treatments (PRTs) that are used in the United 

States is still an issue. In December 2010, USDA requested the Commission to approve the use 

of lactic acid as a pathogen reduction treatment (PRT) in processing of beef carcasses and meat. 

The European Commission subsequently requested EFSA do a risk assessment on the use of 

lactic acid as a beef PRT. In July 2011, EFSA issued its risk assessment, which concluded that 

beef treated with lactic acid as a PRT is safe for human consumption. After considerable delay, 

the European Commission published a final regulation allowing the use of lactic acid, which 

entered into effect on February 25, 2013.

Cherries

The EU requires cherries to be free of Monilinia fructicola (brown rot) and requires written proof 

that controls have been applied in the field. This requirement limits the supply of U.S. cherries 

that would otherwise qualify for export to the EU. While brown rot is known also to exist in 

some EU Member States, the EU does not require the same field trials for EU Member States 

where brown rot is found. The United States is currently engaged with EFSA to find a resolution 

to this issue. 

Poultry – Pathogen Reduction Treatments 

In 1997, the EU began blocking imports of U.S. poultry products that had been processed with 

PRTs. The EU has further prohibited the marketing of poultry as “poultry meat” if it has been 

processed with PRTs. In late 2002, the United States requested the EU to approve the use in the 

processing of poultry intended for the EU market of four PRTs that are approved for use in the 

United States: chlorine dioxide, acidified sodium chlorite, trisodium phosphate, and peroxyacids.

Between 1998 and 2008, various EU agencies issued scientific reports concerning poultry 

processed with these PRTs. Taken together, the reports conclude that residues of these PRTs do 

not pose a health risk to consumers.

In May 2008, the European Commission, after years of delay, prepared a proposal that approved 

the use of the four PRTs for processing of poultry, but imposed highly trade restrictive 

conditions that did not appear to be based on science. EU Member States rejected the 

Commission’s flawed proposal, first at the regulatory committee level and then, in December 

2008, at the ministerial level.

In January 2009, the United States requested consultations with the EU on whether the EU’s 

failure to approve the four PRTs was consistent with the EU’s commitments under various WTO 

agreements, including the SPS Agreement. The United States and the EU held those 

consultations in February 2009 but failed to resolve the matter. In November 2009, the WTO 

Dispute Settlement Body established a panel to address the matter. That litigation is pending.
47

Ractopamine

The EU currently maintains a ban on pork produced with ractopamine, a feed additive that 

promotes feed efficiency in pigs and certain other livestock, despite U.S. government approval,

establishment of a Codex standard, and scientific evidence indicating that ractopamine can be 

used safely. As a consequence of this ban, U.S. pork exporters must participate in the 

burdensome Pork for the EU Program to verify that the pork has not been produced using 

ractopamine. In addition, U.S. pork shipments to the EU must undergo expensive laboratory 

testing to verify the absence of ractopamine residue. These requirements, which appear to lack 

scientific justification, pose a major impediment to U.S. pork exports to the EU, confining U.S. 

exports to a small group of U.S. suppliers. On July 5, 2012, Codex adopted standards for the 

maximum residue levels for ractopamine. The United States will continue to encourage the EU 

to implement the international standards or provide sufficient scientific evidence to support its 

unwarranted SPS trade barriers. 

Seafood

Prior to 2008, the EU authorized imports of U.S.‐origin molluscan shellfish under the terms of 

the United States‐European Community Veterinary Equivalence Agreement. In 2008, the 

Commission’s Directorate General for Health and Consumers notified FDA that the import 

approval for U.S.‐origin molluscan shellfish would expire at the end of 2009. Despite high‐level 

U.S. Government engagement on the issue, the EU began barring imports of all U.S.‐origin 

molluscan shellfish other than scallops in July 2010.

Since that time, the U.S. Government has actively engaged with the European Commission on 

this issue and has provided the EU sufficient evidence that U.S. molluscan shellfish are safe to 

consume. The United States considers that it has provided the EU the information it needs in 

order to reach an equivalence determination and allow imports of U.S. molluscan shellfish to 

resume.

Animal Health

Animal By-Products

Tallow

In 2002, the EU published Regulation (EC) 1774/2002, which established problematic new 

requirements related to BSE for marketing animal by‐products that are not intended for human 

consumption, including by-products used in materials intended for animal consumption. The 

regulation effectively prohibited the import of U.S. tallow that is not intended for human 

consumption. Between 2002 and 2007 the United States and the EU engaged in discussions 

resulting in an agreement with the EU to amend its regulation to allow tallow for some technical 

purposes. In the years 2007-2009 the EU stated that they had to wait until they had replaced 

Regulation (EC) 1774/2002 to make those changes.
48

In 2009, the EU published Regulation (EC) 1069/2009, which began the process of replacing 

Regulation (EC) 1774/2002. Upon publication of Regulation (EC) 1069/2009, the EU stated that 

the changes related to tallow would not come until new implementing regulations for Regulation 

(EC) 1069/2009 were implemented. In 2011, the EU published Regulation (EU) 142/2011, 

which took effect in March 2011 and did revise the requirements for importing tallow. While 

this regulation contained requirements for tallow intended for technical purposes that exceeded 

the recommendations of the OIE, the EU assured the United States that the EU would not apply 

the regulation in such a manner to block the import of U.S. tallow intended for certain technical 

purposes. U.S. industry began preparing to meet these new requirements. However, in 2012, the 

EU began applying the regulation in such a manner to effectively prohibit the import of U.S. 

tallow. Later in 2012, the United States began high level discussions with the EU to try to reopen the market. As a first step, the EU is preparing a draft amendment that could remove the 

effective prohibition on tallow intended for the manufacture of biodiesel, while retaining some 

costly requirements for U.S. producers. The United States continues to press the EU to remove 

those unwarranted requirements and allow more market access for U.S. tallow. 

See section III.C for an explanation of the BSE trade issue.

Milk

Under requirements for dairy product imports, the EU limits the number of somatic cells in raw 

milk, as measured by the somatic cell count (SCC). This requirement is burdensome for U.S. 

exporters, as the FDA allows raw milk to be sold in the United States with higher SCC levels 

than the EU does. Moreover, the FDA considers the SCC level to be a quality rather than food 

safety criterion and, as such, SCC should not be required for public health purposes. The United 

States will continue to work with EU authorities to resolve these issues.

EU Country Specific Issues

Austria

Agricultural Biotechnology 

Since 1997, Austria has maintained a series of cultivation and import bans on agricultural 

products derived from GE. The United States challenged several of these bans at the WTO, 

which found them inconsistent with Austrian and EU obligations under the SPS Agreement. In 

May 2008, Austria lifted its import bans on the MON 810 corn (a pest‐resistant corn variety) and 

T25 GE corn varieties, but left in place its cultivation ban on these varieties. Moreover, in July 

2008, Austria issued new import bans on MON 863 corn as well as on three rapeseed (canola) 

lines.

See section III.B for an explanation of the agricultural biotechnology trade issue.
49

Bulgaria

Agricultural Biotechnology

In March 2010, Bulgaria issued a new biotechnology law, which prohibits the cultivation of GE 

crops in all protected regions, as well as surrounding areas. The combined restrictions cover the 

entire country and, in effect, ban all biotech field trials and production. In addition, the law 

requires the Minister of Agriculture to invoke a “safeguard clause” for a particular GE crop in 

Bulgaria whenever another Member State applies a safeguard clause for that same crop in its 

own territory. Separately, in July 2010, Bulgaria enacted a prohibition on the use of GE products 

and ingredients in the production of foods for children and in baby food. The new regulation 

also banned distribution and sale of GE foods and food products in nurseries, kindergartens, and

schools, as well as in retail outlets and within 100 meters of such establishments. The United 

States has raised concerns with these measures with the government of Bulgaria and has asked 

Bulgaria to provide justifications for them.

See section III.B for an explanation of the agricultural biotechnology trade issue.

France

Agricultural Biotechnology 

Cultivation in France of MON 810 corn grew from 500 hectares in 2005 to 22,000 hectares in 

2007. However, in January 2008, following a review by a new “interim” biotechnology 

authority, France banned the cultivation of MON 810 and invoked the “safeguard” clause under 

EU regulations. In October 2008, EFSA found that France had presented no scientific basis to 

justify the safeguard measure. Nonetheless, France has left in place its ban on the cultivation of 

MON 810. While the French State Council lifted the ban November 2011, pursuant to

the conclusions of the European Court of Justice, France re-initiated its national ban on the 

cultivation of MON 810 on March 18, 2012. The press revealed that the Government of France 

reinitiated the ban without the advice of the High Council on Biotechnology.

See section III.B for an explanation of the agricultural biotechnology trade issue.

BPA Ban

In late 2012, France adopted legislation that bans the use of materials produced using bisphenol 

A (BPA) in food contact surfaces for food products designed for infants or pregnant and lactating 

women, effective in January 2013, and for all foods beginning in 2015. In addition, the law 

requires the development of warning labels to be placed on all foods. If fully implemented, this 

measure is expected to severely limit U.S. exports of canned and many packaged foods, which 

can use packaging containing BPA. Currently, the U.S. Government is engaging with other 

stakeholders while considering options. The U.S. Government has expressed its concerns via a 

demarche to the French Prime Minister and French officials at the Ministries of Health, 

Agriculture, Trade and Finance, and has discussed the issue with the European Commission. 
50

Germany

Agricultural Biotechnology

In 2009, Germany banned the cultivation of MON 810 corn and invoked the “safeguard” clause 

under EU regulations. EFSA determined that Germany had not presented any scientific evidence 

to justify the new ban. Despite the EFSA evaluation, the German Agricultural Ministry has 

maintained the MON 810 ban.

See section III.B for an explanation of the agricultural biotechnology trade issue.

Greece

Agricultural Biotechnology

Greece maintains a ban on all biotech cultivation as well as the importation of several GE 

products. Since April 2005, Greece has implemented and extended bans on MON 810. In July 

2008, EFSA determined that Greece’s ban lacked a scientific basis. Nevertheless, in August 

2009, Greece extended the ban for another two years and expanded the measure to include 

cultivation. Greece now maintains its bans on MON 810 by invoking the “safeguard clause”

under the EU regulations.

See section III.B for an explanation of the agricultural biotechnology trade issue.

Hungary

Agricultural Biotechnology

In 2011, Hungary implemented new rules relating to GE seed testing. The testing policy does 

not address any identifiable environmental or health risks, the testing methodologies are not 

transparent, and test results may not be challenged on technical grounds. In senior level 

meetings, USDA registered concern with how Hungary is handling the issue of seed testing and 

advocated the importance of science-based, transparent regulations to agricultural investment.

Hungary maintains three differing testing policies based on the origin of the seed. Seed 

produced in Hungary is subject to random testing for the presence of GE products, but no 

comprehensive testing and certification is required. Seed imported from another EU Member 

State is required to have a testing certificate from an accredited EU laboratory. Seed imported 

from a third country requires testing by a Hungarian government laboratory. As the Hungarian 

laboratories do not follow transparent processes, do not use standard methodologies, and do not 

allow test results to be challenged, non-EU seed producers appear to be at a disadvantage to EU 

seed producers.

In 2012, Hungary adopted an amendment to its 1998 Act on Biotechnology. The amendment 

refines the rules that apply to non-commercial release of GE varieties for research purposes, 
51

expands the regulatory powers of the relevant Hungarian authorities, and mandates that 

administrative procedures for imports of GE food and feed align with EU rules. 

See section III.B for an explanation of the agricultural biotechnology trade issue.

Italy

Agricultural Biotechnology

Numerous actions attest to the fact that Italy is pursuing a GE-free strategy. Italy has one of the 

most anti-GE voting records in the EU and has failed to authorize biotech field trials despite EU 

ministerial approval. For the past decade, Italy has maintained a de facto ban on the cultivation 

of EU-approved GE crops by creating fragmented national and regional biotech authorities in 

addition to the EU authority. Moreover, Italy has not established a national legal framework for 

the cultivation of GE products. Seed importers report that they are subject to criminal penalties 

for the adventitious (i.e., accidental or unintended) presence of GE seeds in commercial 

shipments of non-GE seeds. 

In September 2012, the European Court of Justice (ECJ) issued a decision that Italy’s additional 

national authorization procedures for GE crops are unlawful, concluding that the cultivation of 

such varieties cannot be made subject to a national authorization when their use has been 

authorized at the EU level. The ECJ was ruling on a case brought against the Italian Ministry of 

Agriculture, which had denied authorization to plant a GE corn variety pending the adoption of a 

national coexistence measures. 

Latvia

Agricultural Biotechnology

On June 18, 2009, Latvia modified its Law on Circulation of Genetically Modified Organisms to 

grant decision‐making authority on biotech cultivation to local municipalities. Since passage of 

the law, 95 percent of the 109 municipalities in Latvia have banned the cultivation of GE crops 

in response to strong consumer activism and tacit support of the Ministry of Environment. 

According to Latvia’s Ministry of Environment, the basis for the current regulation is the “EU 

Environment Ministers agreement ‐ Council Conclusions,” which notes that GE-free zones can 

be created on the basis of voluntary agreements among the “economic operators” in an area.

Prior to June 18, 2009, Latvian law provided that only the Cabinet of Ministers could prohibit 

biotech plantings and such a decision had to be based on scientific evidence that a specific GE 

crop posed safety concerns for the environment, health, or economy. The United States has 

engaged the government of Latvia regarding this shift in policy and has requested further 

information about the basis for the current biotech cultivation bans.

See section III.B for an explanation of the agricultural biotechnology trade issue.
52

Luxembourg

Agricultural Biotechnology

In March 2009, Luxembourg banned the cultivation of MON 810. EFSA found that 

Luxembourg’s ban lacked a scientific basis, yet the ban remains in place.

See section III.B for an explanation of the agricultural biotechnology trade issue.

Poland

Agricultural Biotechnology

Since 2006, Poland has not only opposed the approval of GE crops at the EU level, but has taken 

official steps to become “GE‐free.” In 2006, Poland passed legislation that banned the sale and 

registration of GE seeds, restricted Polish representatives to the European Parliament from 

supporting pro-biotechnology legislative proposals, and prohibited the importation, production, 

and use of animal feed derived from GE crops beginning in August 2008. On August 28, 2012 

the Polish President Komorowski signed an amendment to the Feed Act pushing back the 

implementation of a ban on entry, prohibition of manufacturing, marketing, and use of animal 

feeding containing GE components till January 1, 2017. Current legislation envisaged that the 

ban was to be implemented on January 1, 2013. The signed amendment ensures access for 

imported feed with GE component to Poland until at least the end of 2016. 

On December 21, 2012, President Komorowski signed into law amendments to the Law of the 

Seed that should bring Poland into compliance with EU legislation. On January 2, 2013, the 

Polish Council of Ministers, at the request of the Minister of Agriculture, re-authorized its 2008 

framework position on agricultural biotechnology and permitted the Ministry to ban cultivation 

of GE crops by applying the EU safeguard clause. On January 28, 2013, the ban on GE crop 

cultivation entered into force along with the amended Law of the Seed.

See section III.B for an explanation of the agricultural biotechnology trade issue.

Portugal

Agricultural Biotechnology

In May 2010, the Autonomous Region of Madeira (a Portuguese archipelago) became the first 

region of the EU to declare itself free of biotech cultivation after the European Commission 

failed to oppose Madeira’s request by the legislated deadline. Madeira’s authority for the ban 

was further codified when, in July 2010, the Commission announced new “co‐existence” 

measures that authorize Member States to allow, restrict, or ban the cultivation of GE crops in 

part or all of their territory. The net effect of the Madeira GE‐free declaration is that no GE 
53

crops can be grown in Madeira. The United States has raised this issue in bilateral meetings with 

Portugal.

See section III.B for an explanation of the agricultural biotechnology trade issue.

INDIA

Food Safety

Dairy Products

Since 2003, India has imposed unwarranted SPS requirements on dairy imports, which have 

precluded U.S. access to India’s dairy market, one of the largest in the world. For example, India 

requires the U.S. Government to certify that any U.S.-origin milk destined for India has been 

treated to ensure the destruction of paratuberculosis, whose presence, according to India, is 

linked to Crohn’s Disease, a conclusion the United States disputes. The United States maintains 

that the presence of paratuberculosis in dairy products does not pose a human health risk, and 

India should not make elimination of this bacterium a condition for issuing an export certificate 

for U.S. dairy products. 

In addition, despite repeated requests from the United States, India has not provided scientific 

evidence to substantiate its requirements regarding ruminant-origin materials in dairy cattle feed. 

India has also declined to take into account evidence that this feeding practice poses no safety 

concerns. 

See section III.A for an explanation of the export certification trade issue.

Pork

The Indian import certificate for pork requires that importers make an attestation that the 

imported pork does not contain any residues of pesticides, veterinary drugs, mycotoxins, or other 

chemicals above the MRLs prescribed in international standards. However, these certificates fail 

to identify specific compounds and their corresponding international limits, creating uncertainty 

for importers. India restricts the importation of pork that has been fed ruminant-derived protein, 

which is inconsistent with OIE guidelines. Similarly, the animal health attestations that India 

requires are vague, and India's demands for extra inspections do not appear to be consistent with 

international standards. India also prohibits imports from the United States of pork products 

obtained from animals raised outside the United States, notwithstanding the safety of those 

products. Further, import certificates are valid for only six months, and certificates must be 

obtained for each imported lot. The United States will continue to press India to lift the 

unwarranted restrictions and revise the import certificates to clarify any legitimate requirements 

and be valid for a reasonable period of time. 

India only allows imports of U.S. pork from plants that inspectors have certified are free of 

PRRS, trichinae, transmissible gastroenteritis, atrophic rhinitis, leptospirosis and anthrax for two 

years prior to slaughter. The United States does not consider these requirements to be necessary 
54

as U.S. producers maintain stringent biosecurity protocols that serve to limit the appearance of 

these diseases in the United States to extremely low levels. The United States continues to 

discuss this issue with India. 

See section III.A for an explanation of the export certification trade issue.

Animal Health

Poultry, Swine, and Pet Food

Since 2006, India has banned imports of U.S. poultry, swine, and related products purportedly 

because of LPAI outbreaks in the United States. The United States has repeatedly raised 

concerns in the WTO SPS Committee about India’s import bans, and has discussed these 

concerns with Indian officials numerous times, including at a high‐level during the U.S.‐India 

Trade Policy Forum. The United States and other trading partners have requested that India lift 

its ban. 

In order to further address this matter, the United States requested WTO dispute settlement 

consultations with India regarding its import ban on March 6, 2012. Consultations were held in 

Geneva in May 2012. The consultations did not lead to a resolution of the dispute. A dispute 

settlement panel has been established, and the United States is continuing to pursue this matter. 

India also continues to require AI certification statements for dry processed pet food. This 

requirement does not appear to be consistent with OIE guidelines and has effectively stopped 

imports of dry processed pet food.

See section III.A for an explanation of the export certification trade issue and section III.D for an 

explanation of the AI trade issue.

Plant Health

Wheat and Barley

India maintains zero-tolerance standards for certain plant quarantine pests, such as weed seeds 

and ergot, which block U.S. wheat and barley exports. Bilateral discussions to resolve these 

issues continue. India has agreed to collaborate further by exchanging ergot strains and testing 

them on barley under controlled conditions. 

See section III.A for an explanation of the export certification trade issue.
55

INDONESIA

Food Safety

Beef and Pork

Indonesia continues not to recognize the equivalence of the U.S. inspection system for both beef 

and pork, and instead requires U.S. meat plants to complete an extensive questionnaire that 

includes proprietary information. In addition, Indonesia’s document review process has resulted 

in approval of only a limited number of U.S. plants. Several U.S. beef and pork establishments 

submitted applications more than two years ago and still have not obtained approvals. 

Following the April 2012 finding of a dairy cow with atypical BSE in the United States, 

Indonesia modified its import requirements to only permit access for boneless beef from cattle 

less than 30 months of age based on unwarranted BSE concerns. These BSE-related restrictions, 

combined with Indonesia's restrictive import licensing scheme, have resulted in the virtual 

closure of the market to U.S. beef. 

The United States has raised these concerns with Indonesia repeatedly, including at the U.S.-

Indonesia Trade and Investment Framework and at the WTO SPS Committee.

See section III.C for an explanation of the BSE trade issue.

Animal Derived Products

In October 2009, Indonesia announced Law 18/2009, which requires companies that export 

animal‐derived products, such as dairy and eggs, to Indonesia to complete a pre‐registration 

process with the Indonesian Ministry of Agriculture. The law allows imports of these products 

only from facilities that the Indonesian authorities have individually audited and approved. 

Indonesia issued implementing regulations in November 2011 that impose overly stringent 

requirements concerning animal health and food safety. To date, Indonesia has not notified the 

WTO of Law 18/2009. 

In September 2011, the United States hosted a team of Indonesian inspectors for an audit of the 

U.S. food safety system as it applies to dairy products. The Indonesian team provided the United 

States an audit report within two months after the audit concluded, and agreed to a simplified 

questionnaire for U.S. dairy facilities seeking to pre-register for review and approval. The 

United States and Indonesia are currently working together to improve the system under which 

U.S. establishments are made eligible to export dairy products to Indonesia. At the same time, 

the United States will continue to work to resolve impediments under Indonesian law to imports 

of U.S. meat and poultry products, including the restrictive regulations that Indonesia has put in 

place to implement Law 18/2009.
56

ISRAEL

Food Safety and Animal Health

Live Cattle, Beef, and Beef Products

In 2003, Israel restricted U.S. exports of live cattle, beef, and beef products following the 

detection of a BSE-positive animal in the United States. These restrictions do not appear to be 

consistent with OIE guidelines. Although Israel’s 2011 policy on BSE permits imports of U.S. 

cattle, small ruminants, and associated breeding material, the United States and Israel have not 

agreed on a protocol for the import of live cattle, beef, and beef products from the United 

States. In 2012, the United States and Israel began re-engaging on this issue and have made 

significant progress with regard to export certificates.

See section III.A for an explanation of the export certification trade issue, and see section III.C 

for an explanation of the BSE trade issue.

Plant Health

Apples and Pears

In March 2009, Israel’s Plant Protection and Inspection Service informed the United States that 

U.S. apples and pears would be subject to new cold treatment requirements to mitigate the risks 

of two pests, the apple maggot and the plum curculio. Israel has not conducted a PRA, and these 

pests have not been found in shipments from the United States. Israel granted the United States 

an exemption from this requirement until September 1, 2012. During that time, USDA officials 

worked with industry and state officials on implementing the cold treatment requirement. 

During bilateral meetings held in December 2012, Israeli officials approved three cold treatment 

processes, and approved of an additional cold treatment process for fruit from the eastern United 

States until July 15, 2013, pending the outcome of ongoing APHIS cold treatment research on 

apple maggot eggs. The United States and Israel also reached agreement that pears shipped 

under commercial conditions would not be regulated for apple maggot eggs. 

Cherries

For nearly nine years, Israel has banned imports of U.S. sweet cherries, citing risks from various 

plant pests and diseases. U.S. officials are working with Israel to complete Israel’s risk 

assessment on sweet cherries in an attempt to resolve this longstanding issue. During technical 

bilateral meetings in August 2010, Israel agreed to expedite the risk assessment for U.S. sweet 

cherries. During bilateral meetings held in December 2012, Israel indicated that it is close to 

completing its risk assessment.
57

JAMAICA

Animal Health

Pork

Jamaica currently bans imports of U.S. pork due to concerns regarding pseudorabies disease 

virus. Jamaica continues to work with the United States to complete a risk assessment and the 

U.S. request for an equivalence determination. This issue was raised at the March 2012 U.S.-

Caribbean Community (CARICOM) Trade and Investment Council meeting. The United States 

will continue to engage with Jamaica to open its market to U.S. pork. 

JAPAN

Food Safety

Beef and Beef Products

In December 2003, Japan banned U.S. beef and beef products following the detection of a BSEpositive animal in the United States. In July 2006, Japan partially reopened its market to allow 

imports of some U.S. beef and beef products from animals aged 20 months or younger produced 

under a special program for Japan. However, additional conditions imposed by Japan, including 

certain border measures, are restrictive and have made it difficult for the United States to regain 

a level of trade that approaches historic levels of exports to the Japanese market. 

In December 2011, as the first step of a process to reassess its BSE-related trade restrictions and 

at the request of Japan’s Ministry of Health, Labor and Welfare, the Japanese Food Safety 

Commission (FSC) initiated a risk assessment to examine raising the maximum age of the cattle 

from which U.S. beef can be exported to Japan, as well as revising the definition of specified risk 

materials (SRMs). In October 2012, the FSC issued its final risk assessment, which 

recommended that Japan: (1) raise the age limit for cattle from which U.S. beef and beef 

products can be exported to Japan from 20 months of age to 30 months, and (2) adopt a revised 

definition of SRMs that is closely aligned with the international standards of the OIE.

Based on the FSC risk assessment, Japan entered into consultations with the United States with 

the aim of revising Japanese import requirements for U.S. beef and beef products. In January 

2013, the United States and Japan agreed on new terms and conditions for the export of U.S. beef 

and beef products to Japan. Under these new terms, which entered into effect on February 1, 

2013, Japan now permits the import of beef from cattle less than 30 months of age, among other 

steps. It is estimated that these important changes will result in hundreds of millions of dollars in 

additional exports of U.S. beef to Japan in the coming years. The two governments also agreed 

to regular and ad hoc consultations to review progress under the agreement and address any 

issues that may arise. In an accompanying letter exchange, Japan also confirmed its ongoing 

BSE risk assessment by the FSC, which includes a consideration of raising the age limit above 
58

30 months for beef and beef product imports from the United States, taking into account 

international standards.

See section III.C for an explanation of the BSE trade issue.

Food Additives

Japan’s regulation of food additives has restricted imports of several U.S. food products, 

especially processed foods. Many additives that are widely‐used in the United States and 

throughout the world are not allowed in Japan. In addition, U.S. manufacturers have complained 

about the prolonged approval process for indirect food additives (i.e., additives that do not 

remain on food, such as solvents).

In 2002 Japan created a list of 46 food additives that would be subject to an expedited approval 

process. More than 10 of the 46 additives remain unapproved. The United States understands 

that Japan is currently reviewing the remaining additives. The United States has urged Japan to 

complete work on the reviews and to develop a meaningfully expedited process for reviewing all 

future requests for food additive approvals. U.S. officials have also requested Japan to use such 

an expedited review process for additional, globally‐used additives.

Gelatin 

Japan banned the importation of U.S.‐origin ruminant gelatin and collagen for human 

consumption (along with the importation of most other ruminant origin tissues from the United 

States) following the detection in December 2003 of a BSE-positive animal in the United States. 

Although the restrictions on some ruminant‐origin products have been amended to allow for their 

importation, no modification has been made to the prohibition on ruminant‐origin gelatin for 

human consumption. This import ban appears to be inconsistent with OIE guidelines. The 

United States will continue to press Japan to lift the ban on gelatin and collagen, including from 

bovines of more than 30 months of age, consistent with science and OIE guidelines.

See section III.C for an explanation of the BSE trade issue.

Pre and Post Harvest Fungicides

Japan’s food safety regulations require a risk assessment for the pre‐harvest application of a 

fungicide. However, Japan classifies fungicides that are applied post‐harvest as food additives 

and requires them to undergo a separate risk assessment. As a result, registrants of fungicides 

that may be used both pre‐ and post‐harvest must ensure that two risk assessments are performed, 

a process that is redundant and that can take as long six years to complete. The requirement for 

dual risk assessments deters registrants from pursuing approval for new and safe products. 

Japan’s dual risk assessment requirement does not have a significant impact on domestic 

producers, as Japanese farmers do not generally apply fungicides after harvest.

Japan’s policy appears to be inconsistent with Codex standards and widely accepted procedures 

among countries with robust pesticide regulatory systems. Countries assessing the risk posed by 
59

a fungicide generally perform a single risk assessment, which takes into account the manner in 

which the fungicide is applied and focuses on the characteristics of the residue and the amount of 

residue present, regardless of the time of application to the crop.

In May 2010, Japan announced a decision to streamline the review process for agricultural 

chemicals applied both as pesticides (pre‐harvest application) and as food additives (post-harvest 

application), although it remains unclear as to whether this modified process will reduce the 

length and duplication of the previous process. The United States has made numerous requests 

of Japan to streamline its review process, and will continue to monitor this process and work 

with Japan to eliminate duplicative review requirements.

Maximum Residue Limits

In July 2009, the United States and Japan concluded an MOU on MRLs that changed the way in 

which MRL violations are handled by establishing a mechanism under Japan’s import and food 

monitoring policy for shippers to address violations quickly. While there has been progress in 

how MRL violations are handled, the United States remains concerned that Japan’s procedures 

still require industry-wide enhanced surveillance for a given product after a single violation by a 

single shipper. 

In addition, Japan’s slow and burdensome review process for approving pesticides and 

fungicides and the lack of established MRLs continue to create risk of unnecessary trade 

disruptions. The United States continues to work closely with Japan on these issues, including 

through data exchanges aimed at assisting Japan in its approval of new MRLs. 

See section III.E for an explanation of the MRL trade issue.

Animal Health

Poultry

U.S. poultry meat and poultry products, including egg products, are currently exported to Japan 

in accordance with a 2002 animal health protocol purportedly aimed at preventing AI. Japan 

unilaterally implemented the protocol, which limits market access for these U.S. products in a 

manner that appears to be inconsistent with the OIE guidelines on AI. While the United States 

and Japan agreed to modifications of the protocol in 2012, which addressed some of the 

problematic requirements related to HPAI, Japan continues to impose LPAI-related restrictions 

that do not appear be consistent with OIE recommendations. The United States continues to 

press Japan to agree to a fully OIE‐consistent revised protocol and discontinue LPAI based 

restrictions on these commodities. 

See section III.D for an explanation of the AI trade issue.
60

Plant Health

Fresh and Chipping Potatoes

Until January 2006, Japan banned all imports of fresh potatoes from the United States due to 

phytosanitary concerns. On February 1, 2006, Japan’s Ministry of Agriculture, Forestry and 

Fisheries (MAFF) and USDA reached an agreement to allow limited imports of U.S. fresh 

potatoes from 13 states to produce potato chips. The agreement limited shipments to a single 

chipping facility and provided for a shipping period of just five months (February to June).

Once the agreement was implemented, USDA began working steadily with MAFF to expand 

access for U.S. potatoes. This work has resulted in a $5 million per year increase in exports. In 

2010, an additional state (Washington) was added to the list of states eligible to ship chipping 

potatoes to Japan. In June 2011, MAFF approved a second chipping facility to process U.S. 

potatoes. In July 2011, MAFF extended the eligible shipping period to include July. During 

2012 USDA continued to negotiate with Japan for increased access for U.S. potatoes. 

New Cherry Varieties

U.S. cherries can currently be exported to Japan subject to either fumigation treatment or a 

systems approach of phytosanitary safeguards. Japan does not maintain varietal restrictions for 

cherries imported in accordance with systems approach safeguards. However, with regard to 

fumigation treatments, Japan only approves imports of new fresh cherry varieties based on 

individual fumigation trials. This burdensome process, which involves testing the efficacy of 

fumigation treatments for each separate variety, restricts the entry of new cherry varieties into 

the Japanese market. The United States is urging Japan to accept fresh sweet cherries as a single 

commodity under a single fumigation protocol, which would mean that all varieties may be 

imported without the need for separate testing. The United States continues to urge rapid 

resolution of this concern.

KAZAKHSTAN

Systemic Issues

The entry into force of the Customs Union of Russia, Kazakhstan, and Belarus (the “Customs 

Union” or CU) has complicated exports into and trade among the three countries, as they 

harmonize and revise their SPS measures. 

Kazakhstan signed the Agreement of the Customs Union on Sanitary Measures and the

Agreement of the Customs Union on Veterinary and Sanitary Measures on December 11, 2009. 

Since April 2010, Russia, Belarus, and Kazakhstan have concluded many additional agreements 

that harmonize SPS measures. These agreements create a unified list of goods subject to 

veterinary, phytosanitary, and sanitary‐epidemiological control at the customs border and within 

the territory of the CU, set unified veterinary and sanitary epidemiological and hygienic 

requirements for those goods, and establish a single form of documentation used to confirm the 

safety of those goods. On July 1, 2010, the CU implemented harmonized veterinary 
61

requirements, which stipulate that imports of all veterinary-controlled products are eligible for 

entry only if they are from facilities on a common list approved by all three Customs Union 

parties. The CU’s SPS measures have the potential to restrain U.S. exports.

Pursuant to those measures, Kazakhstan now requires any importer or domestic producer of 

certain types of goods to obtain a Certificate of State Registration before the product can be sold. 

In Kazakhstan, the Ministry of Health's Committee of State Sanitary and Epidemiological 

Supervision is responsible for issuing these certificates. Goods subject to this certification 

requirement include:

 mineral water, drinking water in bottles, tonic water, and alcoholic beverages;

 food products produced with genetically‐modified microorganisms;

 food supplements, complex food supplements, perfumes, plant extracts, microorganisms, 

and cultures;

 products for disinfection (except of those used in veterinary services); and

 items designated for contact with food products (except dishes, table amenities, and 

microwaves).

During 2011, the CU amended several of its SPS agreements, including aligning certain SPS 

requirements with international standards. The U.S. Government is working with Kazakhstan to 

encourage improvements in the CU’s SPS regime and to ensure that implementation of the CU’s 

SPS measures is not trade disruptive. In February 2013, APHIS sent a delegation to Moscow to 

negotiate several live animal and germplasm export certificates with the CU countries, including 

Kazakhstan. This will be followed by other U.S. delegations in 2013 to discuss certificates for 

the export of meat, dairy, and animal by-products.

See section III.A for an explanation of the export certification trade issue.

Agricultural Biotechnology

Kazakhstan currently is considering a draft law to regulate the development and testing of

agricultural biotechnology products in Kazakhstan. While the current draft law provides for the 

review and registration of agricultural biotechnology events for import and cultivation in 

Kazakhstan, it also includes rigid timelines for notification and supplementary data submissions 

and lacks clarity with respect to liability and the protection of confidential business information. 

The draft law also establishes a ban on the use of agricultural biotechnology products in food for 

children. The United States has requested Kazakhstan to provide a risk assessment supporting 

the draft law, but Kazakhstan has not done so. The United States has urged Kazakhstan, if it 

approves and implements the law, to consider an interim system for agricultural biotechnology 

approvals to avoid disrupting imports of products currently sold in Kazakhstan. In 2012, as a 

part of the CU with Russia and Belarus, Kazakhstan notified to the WTO a new measure on food 

labeling that includes a provision on labeling of agricultural biotechnology ingredients. The 

United States commented on the highly restrictive regulation. The United States also partially 
62

funded and organized an outreach program in Kazakhstan on agricultural biotechnology 

regulations in November 2012. 

See section III.B for an explanation of the agricultural biotechnology trade issue.

Food Safety

Live Cattle

On January 17, 2013, Kazakhstan placed a temporary ban on imports of all U.S. cattle due to 

bluetongue, a non-contagious, insect-borne viral disease rarely found in cattle, following

detection in a shipment of cattle in December 2012. No official notification was received by the 

United States, nor any timeline provided for a review of the U.S. system or an approvals process, 

and all import permits have been suspended. The United States and Kazakhstan met in January 

13, 2013, to discuss the issue, and as a result a team of U.S experts traveled to Kazakhstan the 

week of January 28, 2013, for technical discussions concerning regulatory oversight. On March 

14, 2013, Kazakhstan announced that it was re-opening the market to U.S. cattle.

Pork

Kazakhstan requires imported pork to be shipped frozen to mitigate the risk of trichinae. The 

United States does not consider this mitigation measure to be necessary for U.S. pork as U.S. 

producers maintain stringent biosecurity protocols that serve to limit the appearance of trichinae 

in the United States to extremely low levels. The United States will continue to work with the 

regulatory authorities in Kazakhstan and the CU to resolve this trade concern. 

KENYA

Agricultural Biotechnology

Following a November 8, 2012, Kenyan Cabinet and Presidential decree, on November 21, 2012, 

the Kenyan Ministry of Public Health ordered public health officials to remove all foods, feed 

and seeds derived from agricultural biotechnology from the market and to enforce a ban on 

agricultural biotechnology food and feed imports. U.S. officials are engaging Kenya on the 

issue.

KOREA

Agricultural Biotechnology

Korea’s regulatory system for agricultural biotechnology has generated concern in recent years 

with regard to its lack of predictability and transparency. In 2008, Korea implemented the 

Living Modified Organisms Act (LMO Act), which regulates trade in agricultural biotechnology 

products, including food and seeds for use as feed or for processing. The United States has 

raised a number of issues related to the LMO Act and its implementing regulations, including 

concerns that certain import documentation requirements go beyond the current provisions of the 
63

Cartagena Protocol on Biosafety, and that Korea’s process for reviewing the product risk 

assessments may be redundant and lacking scientific justification. The process may also lead to 

delays in the approval of new products. The United States is also concerned about Korea’s 

narrow scope of definition for “adventitious presence.” In addition, the United States is 

concerned that the LMO Act, while nominally applying to all living modified organisms (i.e.

plants and animals), was written solely with living modified plants in mind and thus does not 

readily apply to the trans-boundary movement of living modified animals. In late 2012, Korea’s 

National Assembly approved revisions to the LMO Act. The implementing regulations to the 

Act are expected to be revised in 2013 to reflect the recent changes to the Act itself. The United 

States is in the process of reviewing the revised Act to determine if the revisions address U.S. 

concerns. The U.S. and Korean governments will continue to work together to address these 

concerns. 

Korea completed approvals for five new GE plants in 2012. U.S. concerns continue, however, 

with regard to the lack of predictability in Korea’s agricultural biotechnology review process. 

The United States will continue to engage with Korea to avoid significant disruptions to exports 

of U.S. biotech products.

See section III.B for an explanation of the agricultural biotechnology trade issue. 

Food Safety

Beef and Beef Products

Following a 2008 bilateral agreement to fully re‐open Korea’s market to U.S. beef and beef 

products, Korean beef importers and U.S. exporters have operated according to a voluntary, 

commercial understanding that imports of U.S. beef and beef products will be from animals less 

than 30 months of age, as a transitional measure, until Korean consumer confidence 

improves. In 2012, the U.S. exported $582 million worth of beef (including variety meats) to 

Korea, making Korea the fourth-largest export market for U.S. beef. The United States will 

continue to urge Korea to open its market fully to U.S. beef and beef products based on science, 

the OIE guidelines, and the United States’ risk status.

See section III.C for an explanation of the BSE trade issue.

Maximum Residue Limits

Korea has a national MRL list and uses a unique and complicated deferral approval process 

using Codex and other systems when no national MRLs are established. Korea has increased 

pesticide residue testing on U.S. commodities due to residue violations occurring in other 

countries. After a single MRL violation by a U.S. export (including one detected by authorities 

of another country), Korea imposes restrictive requirements on that product’s grower, shipper, 

and importer, and requires that they must make a certain number of compliant shipments before 

the sanctions are removed. 
64

The United States will continue to encourage Korea to maintain the current list of MRLs based 

on the most current available scientific data, or until Korea completes the appropriate risk 

assessments. The United States will also continue to seek guidance from Korea on how U.S. 

pesticide manufacturers and registrants may submit to the Korea Food and Drug Administration 

relevant information and requests for the establishment of import MRLs for pesticides.

See section III.E for an explanation of the MRL trade issue.

Cherries

Korea requires U.S. cherries to undergo fumigation with methyl bromide before shipping. 

Replacing the fumigation requirement with alternative mitigation measures would address 

Korea’s phytosanitary concerns while increasing the shelf life of the cherries, thus allowing 

shipment by ocean vessel rather than air freight and substantially reducing transportation costs. 

The United States has been engaged with Korean quarantine officials since 2008 to agree on an 

alternative mitigation measure to methyl bromide. Korea sent inspectors to California, 

Washington, Oregon, and Idaho to evaluate the step-by-step process used by U.S. producers to 

ensure that various pests are controlled during the growing season. This gave Korean officials a 

better understanding of the U.S. system and ensured that trade continued while both sides work 

to find an alternative mitigation measure to methyl bromide fumigation. The United States will 

continue to work with Korea on this issue.

KUWAIT 

Food Safety

Beef and Beef Products

In 2006, following the detection of a BSE-positive cow in Alabama, two government offices in 

Kuwait – the Kuwait Public Authority for Agriculture and Fishery Affairs and the Municipality 

of Kuwait – banned all live cattle and beef from Oklahoma, not Alabama. USDA has worked to 

rectify the situation, and was able to convince both offices to remove the ban on live cattle and 

beef from Oklahoma. However, the Municipality of Kuwait has refused to remove the ban on 

beef produced in Oklahoma, despite the continued engagement of USDA. The United States will 

continue to urge Kuwait to open its market fully to U.S. beef and beef products based on science, 

the OIE guidelines, and the United States’ risk status.

See section III.C for a discussion of the BSE trade issue.
65

KYRGYZSTAN 

Food Safety

Pork

Kyrgyzstan maintains a ban on U.S pork exports from several U.S. states due to concerns 

regarding the H1N1 virus. Kyrgyzstan instituted the H1N1-related ban on U.S. pork even 

though there is no evidence to indicate that the virus can be conveyed to humans through the 

consumption of pork. The OIE, FAO, and WTO each issued statements shortly after the H1N1 

outbreak calling on countries not to institute import bans on pork on this basis.

MACEDONIA

Food Safety

In what appears to be a consequence of Macedonia adopting EU certificate attestations, 

Macedonia stopped accepting the FSIS meat inspection system as equivalent, and stopped 

accepting the FSIS export certificate without additional attestations. As a result, Macedonia also 

stopped accepting imports of U.S. pork. The U.S. government is working with the government 

of Macedonia to agree on a pork export certificate that does not impose any non-scientific 

barriers to trade and will allow trade to resume.

See section III.A for an explanation of the export certification trade issue.

MALAYSIA

Food Safety

In June 2011, Malaysia’s Department of Veterinary Services (DVS) stopped issuing import 

permits for the United States for frozen and chilled pork products and instituted new 

requirements, which include requiring pork facilities to complete a lengthy application and to 

submit to an audit by DVS at the expense of the producer or the producer’s government. Only 

upon successful completion of these procedures will an import permit be granted. The United 

States has raised concerns over these requirements with Malaysia on multiple occasions and is 

actively working towards a resolution to regain access for U.S. pork exports, including a possible 

systems-based audit of U.S. pork facilities in 2013.

MEXICO

Food Safety

Live Cattle, Beef, and Beef Products 

In March 2004, Mexico became one of the first major markets previously closed to U.S. beef and 

beef products due to BSE concerns to reopen its market when it announced that it would accept 
66

imports of U.S. deboned beef from cattle less than 30 months of age. Mexico currently allows 

the importation of all U.S. beef derived from animals less than 30 months of age. All cattle and 

products derived from cattle over 30 months are banned. 

In October 2008, the United States and Mexico reached an agreement allowing imports into 

Mexico of U.S. breeding cattle born after 1999. In the fall of 2012, the United States and 

Mexico reached agreement on the requirements for the exportation of weasand meat, ground 

beef, head meat, and small intestines. The new procedures have expanded access for the U.S. 

livestock sector. The United States will continue to press Mexico to open fully its market to all 

U.S. live cattle, beef and beef products based on science, the OIE guidelines, and the United 

States’ risk status. 

See section III.C for an explanation of the BSE trade issue.

Plant Health 

Potatoes 

Mexico prohibits the shipment of U.S. fresh potatoes beyond a 26 kilometer zone along the U.S.-

Mexico border. In 2003, the United States and Mexico concluded the Table Stock Potato Access 

Agreement, which provided a process for allowing U.S. potatoes access to the whole of Mexico 

over a three‐year period. Since then, however, Mexico has refused to move forward with further 

implementation of the 2003 agreement, citing pest detections in shipments over the intervening 

years. Over that same period, APHIS and U.S. potato producers have taken steps to address 

Mexico’s concerns, which have resulted in significant drops in pest interceptions. 

In December 2010, the U.S. and Mexican Secretaries of Agriculture agreed to explore alternative 

approaches to resolve this issue, including third‐party mediation. Subsequently, Mexico and the 

United States agreed to mediate this issue under the auspices of the North American Plant 

Protection Organization (NAPPO). The NAPPO decision was released in September 2011. In 

that report, the Mediation Panel identified six pests in their analysis which should be considered 

quarantine pests by Mexico for the pathway “potato for consumption.” The NAPPO report and 

recommendations were agreed to by both the United States and Mexico.

On September 4, 2012, Mexico published an executive order and on November 20, 2012,

Mexico proposed new draft regulations for the importation of potatoes. These draft regulations 

appear to be inconsistent with the panel’s report and if implemented would further restrict market 

access for U.S. potatoes. For example, the draft regulations list 83 quarantine pests, far more 

than the six identified in the NAPPO report and recommendations. The United States has 

submitted formal comments to Mexico, expressing its concerns that the proposed regulations are 

not based on science, nor consistent with the 2003 Table Stock Potato Access Agreement, the 

report and recommendations of the NAPPO Mediation Panel, and the International Plant 

Protection Convention’s requirements regarding phytosanitary measures. The United States will 

continue to press Mexico for a science-based solution. 
67

Stone Fruit

U.S. peach, nectarine, and apricot growers encounter problems exporting to Mexico due to 

Mexico’s requirements to control the oriental fruit moth and other pests considered to be 

quarantine pests by Mexico. The United States has worked to address these measures as they 

apply to growers in California, Georgia, South Carolina, and the Pacific Northwest. 

California

Under the California Stone Fruit Work Plan, Mexico imposes a high level of direct 

oversight on the operations of California stone fruit producers shipping to Mexico as a 

condition for access to Mexico’s market. This program requires the U.S. industry to pay 

for several inspectors representing the Mexican government to inspect their operations 

for the oriental fruit moth and other pests. The United States has sought to reduce the 

expensive Mexican government oversight of U.S. producers through on-going bilateral 

discussions. A draft protocol that would reduce oversight requirements is under 

discussion. 

Georgia and South Carolina 

In 2008, USDA asked Mexico to open its market for stone fruit from Georgia and South 

Carolina. Mexico agreed to complete a PRA in connection with the request. During 

technical discussions in January 2011, Mexico agreed to let Georgia and South Carolina 

export stone fruit in the absence of a completed PRA under a pilot project, based on the 

California Stone Fruit Work Plan. Although the work plan is more stringent and 

expensive to implement than necessary, it allowed Georgia and South Carolina producers 

to begin shipping to Mexico in February 2011. In October 2011, due to interceptions of 

plum curculio, Mexico temporarily suspended shipments. As an alternative to the work 

plan, Mexico has proposed allowing importation of Georgia and South Carolina peaches 

using methyl bromide fumigation treatment under Mexico inspector direct oversight. The 

industry is also interested in market access under irradiation treatment and reduced 

oversight by Mexico. A draft PRA and proposed Irradiation Operational Work Plan are 

under review by Mexico. 

Pacific Northwest 

USDA is awaiting a PRA from Mexico to address a request to allow peaches, nectarines, 

and plums from the Pacific Northwest to be shipped to Mexico. Mexico has stated that in 

the absence of the PRA, it would accept peaches, nectarines, and plums from this region 

only if they were produced under oversight similar to that conducted in California. 

Pacific Northwest producers believe that due to the low risk associated with the region, 

any Mexican export program should require minimal oversight. The United States and 

Mexico met in January 2011 to discuss the issue and committed to engage in further 

discussion. Mexico is in the process of completing the PRA and, in that regard, 

conducted a site visit in November 2011.
68

MOROCCO

Food Safety and Animal Health

Morocco restricts imports of U.S. live cattle, beef, and beef products due to concerns over BSE 

and growth hormones, and restricts imports of U.S. poultry and poultry products due to AI and 

Salmonella concerns. Morocco and the United States are working to reach agreement on 

sanitary certificates consistent with international standards that would allow U.S. producers to 

export these products to Morocco. At the December 2012 United States-Morocco Joint 

Committee meeting, the United States and Morocco agreed that work on resolving these

longstanding issues would continue through ongoing engagement between the technical experts. 

See section III.A for an explanation of the export certification trade issue, see section III.C for an 

explanation of the BSE trade issue, and see section III.D for an explanation of the AI trade issue.

NEW ZEALAND

Animal Health

Pork

New Zealand restricts imports of fresh pork from the United States in consumer‐ready form due 

to concern about PRRS. In April 2009, after several years of consultation and analysis, New 

Zealand issued four new Import Health Standards (IHS) for pig meat, pig meat products, and by‐

products from the United States, Canada, the EU, and Mexico. The new standards allow imports

of chilled and frozen pork, but the chilled products are to be in 3 kilogram or less consumer 

ready packs. The domestic pork industry opposed the new standards in the courts on the grounds 

that the IHS process was not followed properly and the scientific evidence for the new standards 

was not strong enough. On March 18, 2013, the New Zealand Court of Appeals dismissed the 

New Zealand Pork Industry Board’s appeal. The United States continues to engage with New 

Zealand on this issue. 

NORWAY

Agricultural Biotechnology

With limited exceptions, since 1996 Norway has effectively banned the importation of 

agricultural biotechnology products. The United States continues to press Norway to open its 

market to U.S. exports of those products.

See section III.B for an explanation of the agricultural biotechnology trade issue.
69

Food Safety

Beef and Beef Products

Norway applies EU regulations that ban imports of meat from animals treated with growth 

hormones.

See the discussion of the EU’s hormone ban for more detail.

PERU

Agricultural Biotechnology

In December 2011, Peru adopted a ten-year moratorium on imports and production of GE 

products, except for GE products used in research in a confined environment, in pharmaceutical 

or veterinary products, or for food, feed or processing. A risk assessment must be performed for 

these excepted products, and to date Peru has not conducted any GE-related risk 

assessments. The United States is concerned that Peru’s potential lack of capacity to conduct 

risk assessments for GE products and to test for the presence of GE products in imported 

commodities could create uncertainty in the market and potentially disrupt U.S. exports. In 

November 2012, Peru published Implementing Regulations for the enforcement of the 

moratorium. The regulations do not provide necessary practical guidance for implementation, 

such as specifying the sampling size or procedures for testing of imported seeds. The regulations 

also include steep penalties for the presence of GE materials in imported seeds, even if 

inadvertent or in low levels. As a result, U.S. exports of conventional seeds to Peru (valued at 

over $7 million in 2011) have stopped. The United States continues to raise concerns with Peru 

in bilateral meetings.

See section III.B for an explanation of the agricultural biotechnology trade issue.

Food Safety

Pork

Peru requires U.S. pork be shipped to its market frozen or be tested due to concern over 

trichinae. The United States believes that this requirement is unnecessary as U.S. producers 

maintain stringent biosecurity protocols that serve to limit the incidence of trichinosis in the 

United States to extremely low levels. The United States has requested that Peru revise these 

requirements for fresh and chilled pork and provided evidence to Peru in May 2012 that supports 

this request. The United States raised the issue at the United States-Peru FTA SPS Committee 

meeting in June 2012, and the United States will continue to engage Peru to resolve this trade 

concern. 
70

Animal Health

Live Cattle

Peru continues to ban all U.S. live cattle due to BSE‐related concerns following the detection of 

a BSE-positive animal in the United States in 2003. Prior to April 2010, Peru and the other three 

CAN Member States (Bolivia, Colombia, and Ecuador) maintained that CAN rules prevented 

them from lifting their BSE‐related restrictions on live cattle. In 2009, the United States 

submitted comments on a proposed risk assessment published by CAN that stipulated that only 

live animals under 24 months of age could be imported. CAN Resolution 1314, published April 

2010, stipulated that all CAN Member States are able to elaborate their own requirements 

regarding the importation of live cattle from the United States in accordance with the CAN risk 

assessment. 

USDA provided updated information to Peru in May 2012 to support the U.S. request for market 

access, and the U.S. officials subsequently raised the issue with Peruvian counterparts the June 

2012 meeting of the United States-Peru FTA SPS Committee. The United States continues to 

engage with Peru to re‐open its market for U.S. live cattle based on science, the OIE guidelines, 

and the controlled risk status of the United States.

See section III.C for an explanation of the BSE trade issue.

PHILIPPINES

Plant Health

Market Access for U.S. Vegetables

The United States is concerned with the length of time that it takes for the Philippines to 

complete PRAs for fresh vegetables. The United States requested the Philippines to perform 

PRAs for U.S.-grown broccoli, cauliflower, lettuce, carrots, cabbage, and celery in 2006, and a 

PRA for U.S. fresh potatoes in 2009. The Department of Agriculture (DA) provided its PRAs 

for these products to the United States in May 2011, and USDA is currently evaluating 

them. Until the entire PRA process, including agreement on the PRA results and pest 

mitigations, is completed for each product, the DA will only allow a limited amount of these 

vegetables to enter the country, on a case-by-case basis, for “high-end markets,” such as hotels, 

restaurants, and airline companies.

RUSSIA

Systemic Issues

On August 22, 2012, Russia became a Member of the WTO. Russia is obligated, like all other 

WTO Members, to ensure that its SPS measures comply with the requirements of the SPS 

Agreement (e.g., they are based on scientific principles, not maintained without sufficient 

scientific evidence, and are only applied to the extent necessary to protect human, animal, or 
71

plant life or health). Russia must also comply with its commitments on SPS matters in its 

protocol of accession.

The entry into force of the CU between Russia, Kazakhstan, and Belarus has complicated 

exporting into and trade among the three countries as they harmonize and revise their SPS 

measures. For example, on July 1, 2010, the CU implemented harmonized veterinary 

requirements stipulating that imports for all controlled products subject to veterinary control are 

eligible for entry only if they are produced in facilities on a list approved by all three CU 

countries. The United States worked with Russia to remove products from the list of goods 

subject to veterinary control where no scientific basis supporting their inclusion was apparent, to 

eliminate the requirement that the United States provide a list of all facilities that meet CU 

requirements for goods subject to veterinary control, and to streamline the approval of U.S. 

facilities. In 2011, the CU countries amended the CU agreements to align some of the veterinary 

requirements with international standards, recommendations, and guidelines, but much of this 

work remains uncompleted. In addition, the CU issued new decisions in preparation for Russia’s 

accession to the WTO governing risk assessments and equivalence, harmonization with 

international standards, and inspection of facilities.

U.S. exporters also continue to face systemic issues in Russia related to the certification of 

agricultural products. In particular, Russia requires export certificates for products for which 

certifications are unnecessary or are otherwise unwarranted. For example, Russian certifications 

require phytosanitary attestations for shipments of such processed agricultural products as 

soybean proteins, corn gluten, and distiller’s grains, which, due to the nature of the processing 

process, do not present a pest risk. Likewise, Russia requests U.S. exporters to submit 

certifications stating that the United States is free from various livestock diseases, even where 

there is no risk of transmission from the product in question. To date, the United States has not 

received scientific justifications nor risk assessments for many of Russia’s SPS requirements. 

The United States continues to engage with Russia to modify these requirements and supply the 

United States with scientific justifications, where appropriate.

In November 2006, the United States and Russia signed bilateral agreements to address SPS 

issues related to: trade in pork, beef and beef by‐products, biotech agricultural products, and 

certifications for U.S. pork and poultry establishments that export products to Russia. However, 

there have been implementation problems with several of these agreements. For example, under 

the November 2006 U.S.‐Russia agreement on inspection of meat and poultry establishments, 

Russia agreed to grant U.S. regulatory officials the authority to certify new U.S. establishments 

and U.S. establishments that have remedied a deficiency. In accordance with the agreement, 

Russia also agreed to specific deadlines for responding to requests to list facilities that U.S. 

authorities had inspected and determined to be in compliance with the requirements to export to 

Russia. In practice, however, Russia has not consistently recognized the authority of U.S. 

regulatory officials to certify additional U.S. facilities, and there have been delays in responding 

to U.S. requests to update the list of approved U.S. facilities. 

The CU now has competence for plant inspections, and consequently, the United States is 

currently seeking an agreement with the CU countries regarding inspections for meat and poultry 

plants. The United States worked closely with Russia to negotiate a new CU inspection 
72

regulation that allows the CU to accept guarantees provided by SPS authorities in third countries 

that certify new establishments. 

Veterinary Certificates

Russia requires veterinary certificates to include broad statements by U.S. regulatory officials 

that the products satisfy Russia’s sanitary and veterinary requirements, including meeting certain 

chemical, microbiological, and radiological standards. This requirement is problematic because 

many of Russia’s sanitary and veterinary requirements appear to lack scientific justification. 

See section III.A for an explanation of the export certification trade issue.

Agricultural Biotechnology

Although Russia has established a system for the approval of GE food and feed products, the 

United States continues to have concerns with the implementation of this system, including 

Russia's requirements for re‐registration of approved products, labeling of GE products, and the 

lack of an approval system for the cultivation of GE crops. The United States continues to 

engage Russia to address these specific concerns, as well as to promote greater cooperation on 

agricultural biotechnology generally. Russia has indicated that it expects to adopt additional 

biosafety regulations, including an approval system for the cultivation of GE crops, by 2014. 

See section III.B for an explanation of the agricultural biotechnology trade issue.

Food Safety

Pathogen Tolerances

Russia maintains a zero tolerance policy for all food products, including raw meat and poultry, 

for Salmonella, Listeria, coliforms, and aerobic and anaerobic plate counts. Such a policy is 

unwarranted because it is generally accepted by food safety experts and scientists that these 

pathogens cannot be removed entirely from raw meat and that proper storage, handling, and 

cooking of raw meat and poultry significantly reduce the risk of a number of food‐borne diseases 

caused by these pathogens.

Veterinary Drugs

Russia maintains a zero tolerance policy for residues of unapproved veterinary drugs, many of 

which are commonly used in U.S. animal production, as well as zero or near-zero tolerances for 

veterinary drugs approved in the United States. Findings of veterinary drugs during Russian 

border inspection of U.S. products have resulted in trade disruptions, including the unwarranted 

de-listings of U.S. beef, pork, and poultry facilities. 
73

Ractopamine

In 2012, Russia began enforcing a zero tolerance standard for residues of ractopamine in pork 

and beef, a feed additive that promotes feed efficiency in pigs and certain other livestock, despite 

U.S. government approval of use of this additive, establishment of a Codex standard, and 

scientific evidence indicating that ractopamine can be used safely. On December 7, 2012, Russia 

requested that all pork and beef shipments from countries that use ractopamine in the production 

of pork and beef verify that product exported to Russia contains zero residue of ractopamine or is 

sourced from animals that are not fed ractopamine. Based on the presence of ractopamine in 

various beef and pork, Russia banned all U.S. beef, pork, processed products containing beef or 

pork, turkey, raw materials for casings, and casings, effective on February 11, 2013. The United 

States has requested Russia to suspend these measures and adopt the Codex standards for 

ractopamine. The United States will continue to work with Russia to allow imports of these 

products to resume.

Beef and Beef Products

Currently, U.S. producers may export boneless and bone‐in beef to Russia from cattle under the 

age of 30 months and that meet the requirements set out in the U.S.‐Russia Bilateral Agreement 

on Trade in Beef. Following the completion of consultations regarding the CU veterinary 

requirements, the United States began negotiations with Russia and its CU partners of a new 

sanitary certificate to allow for the export of U.S. deboned beef, bone‐in beef, and beef by‐

products from cattle over 30 months of age to resume.

Current BSE attestations in Russia’s sanitary certificate for prepared meat effectively preclude 

any U.S. cooked beef from qualifying to be imported into Russia. Russia also maintains a ban on 

imports of ground beef from cattle of any age. The United States will continue to urge Russia to 

open its market fully to U.S. beef and beef products based on science, the OIE guidelines, and 

the United States’ risk status.

See section III.A for an explanation of the export certification trade issue, and section III.C for 

an explanation of the BSE trade issue.

Dairy

Russia has effectively banned the importation of U.S. dairy products since September 2010, 

when Rosselkhoznadzor (Russia’s Federal Service for Veterinary and Phytosanitary 

Surveillance) instructed customs officials to allow shipments only from exporters on 

Rosselkhoznadzor-approved lists. During WTO accession negotiations, the United States 

successfully obtained a commitment from Russia that it would no longer require any foreign 

producer to be included on Rosselkhoznadzor lists to be eligible to export dairy products. In 

2012, the United States began negotiations with Russia and the CU on a new certificate that 

would reopen the Russian market to U.S. dairy products. The United States will continue to 

work with Russia and its CU partners to conclude a new certificate.

See section III.A for an explanation of the export certification trade issue.
74

Pork and Pork Products

Russia maintains near-zero tolerance levels for tetracycline‐group antibiotics. Russia agreed as 

part of its WTO accession commitments to submit a risk assessment for tetracycline antibiotics 

conducted in accordance with Codex methodology or align its tetracycline standards with Codex 

standards. The United States, in cooperation with industry stakeholders, reviewed Russia’s risk 

assessment for tetracyclines and provided comments to Russia. The United States continues to 

press Russia to ensure that its measures on this subject are based on science.

Russia also requires U.S. pork to be frozen or tested for trichinosis. Russia's requirements 

constitute a significant impediment to U.S. fresh and chilled pork exports to Russia. The United 

States does not consider these requirements to be necessary because U.S. producers maintain 

stringent biosecurity protocols that limit the appearance of trichinae in the United States to 

extremely low levels. The United States will continue to work with regulatory authorities in 

Russia to resolve this trade concern. 

Poultry

On January 1, 2010, Russia banned the importation and sale of chicken using chlorine as a PRT, 

essentially halting all imports of U.S. poultry into Russia. Bilateral negotiations led to the 

resumption of poultry imports in September 2010, but did not resolve the chlorine restriction 

itself. Russian regulations also place an upper limit on the amount of water content in chilled 

and frozen chicken, despite calls to adopt alternative labeling requirements regarding water 

content. In addition, Russia continues to ban the importation and sale of certain frozen poultry 

for use in baby food and special diets. Russia has not yet provided the United States with risk 

assessments to support these various regulations.

Animal Health

Grains and Oilseeds

Exports to Russia of U.S. grain and oilseed products for use in animal feed are severely limited 

due to Russia’s requirement for producers to provide veterinary certificates warranting that their 

products are free of animal diseases. As part of its WTO accession commitments, Russia 

removed the veterinary certificates requirement for animal feeds of plant origin.

See section III.A for an explanation of the export certification trade issue.

Pet Food and Animal Feed: 

Russia prohibits the use of most U.S. ruminant-origin ingredients in pet foods and animal feeds 

and has in place other restrictions and requirements that are impeding market access.

See section III.C for an explanation of the BSE trade issue.
75

SAUDI ARABIA

Beef and Beef Products

In May 2012, the Saudi Food and Drug Authority (SFDA) banned the importation of U.S. beef 

and beef products due to the detection of a dairy cow with atypical BSE in California in April 

2012. The confirmed case of BSE was the first in the United States since 2006, and only the 

fourth in U.S. history. The dairy cow was 10 years of age and the meat never entered the food 

supply. Nevertheless, the Saudi government has stated that the ban will remain in place until 

SFDA and the Saudi Ministry of Agriculture have evaluated the risks and ensured the safety of 

imports of U.S. beef and beef products. The United States is seeking the removal of the ban in 

accordance with applicable SFDA procedures and has provided SFDA with technical 

information regarding the case. The United States has asked for a report prepared by SFDA 

determining whether audits of U.S. facilities must be performed and, if so, the details and costs 

of any such audits.

See section III.C for an explanation of the BSE trade issue.

SERBIA

Agricultural Biotechnology

Serbia does not currently permit imports of food products that contain trace amounts of 

agricultural biotechnology, but it has indicated that it will amend its biotechnology law to be less 

restrictive within the next six months to facilitate the country's WTO accession process. 

In 2012, U.S. embassies in Belgrade, Sarajevo and Zagreb conducted an agricultural 

biotechnology outreach program in Serbia, Croatia, and Bosnia and Herzegovina to promote 

acceptance of agricultural biotechnology in the region, including by addressing misconceptions 

about agricultural biotechnology and sharing advice for developing a more conducive policy 

environment for agricultural biotechnology products. The program used the GE HoneySweet 

plum, which is resistant to the plum pox, as an example of a crop from which these countries 

would benefit.

SINGAPORE

Food Safety

Beef and Beef Products

Singapore prohibits the importation of all U.S. beef and beef products, except for deboned beef 

from animals under 30 months of age due to BSE concerns. For the past several years, 

Singapore has informed the United States that it is in the process of performing a risk assessment 

of U.S. beef and beef products. The United States will continue to urge Singapore to open its 
76

market fully to U.S. beef and beef products based on science, the OIE guidelines, and the United 

States’ risk status.

See section III.C for an explanation of the BSE trade issue.

Pork

Prior to 2012, Singapore prohibited the use of all PRTs in the production of pork and pork 

products, which added significantly to the cost of exporting pork. Based on documentation 

provided by the United States regarding the safety of certain PRTs, Singapore now allows the 

use of eight PRTs that have risk-assessments completed by the Joint FAO/WHO Expert 

Committee on Food Additives. The United States will continue to work with Singapore to 

approve additional PRTs.

Singapore also requires U.S. pork to be frozen or tested for trichinosis. The United States does 

not consider these requirements to be necessary since U.S. producers maintain stringent 

biosecurity protocols that limit the appearance of trichinae in the United States to extremely low 

levels. The United States will continue to work with regulatory authorities in Singapore to 

resolve this trade concern. 

SOUTH AFRICA

Food Safety

Beef and Beef Products

In June 2010, South Africa opened its market to U.S. deboned beef from cattle of all ages, but 

continues to ban the importation of all other beef cuts and beef products, as well as other U.S. 

ruminant animals and products. The United States will continue to urge South Africa to open its 

market fully to U.S. beef and beef products based on science, the OIE guidelines, and the United 

States’ risk status.

See section III.C for an explanation of the BSE trade issue.

Animal Health

Pork

South Africa imposes stringent time and temperature requirements on pork and pork products 

due to concerns for pseudorabies and trichinae, including a 20‐day freezing requirement on U.S. 

pork to prevent the transmission of pseudorabies. In 1989, the United States started a voluntary 

eradication program for pseudorabies and, in 2004, the United States achieved the successful 

eradication in commercial herds throughout all 50 states. The United States does not consider 

requirements due to trichinae concerns to be necessary since U.S. producers maintain stringent 

biosecurity protocols that limit the appearance of trichinae in the United States to extremely low
77

levels. The United States will continue to work with South Africa to obtain elimination of the 

current freezing requirement for pseudorabies and trichinae.

Plant Health

California Table Grapes

South Africa suspended imports of table grapes from California due to concerns over two plant 

pests: the European grapevine moth and the light brown apple moth. The California Department 

of Agriculture and USDA have implemented comprehensive quarantine programs to prevent the 

dissemination of these pests in California and throughout the United States, as well as to ensure 

that consignments of exported table grapes are free of both pests. The United States has asked 

South Africa to reconsider its suspension of table grape imports from California given the 

phytosanitary mitigation measures currently in place. In addition, the United States and South 

Africa are reviewing options to harmonize both countries’ mitigation measures for mites 

inspection rather than using fumigation.

SOUTH AFRICAN DEVELOPMENT COMMUNITY

Agricultural Biotechnology

South African Development Community (SADC) Member States,7 with the exception of South 

Africa, have banned the importation of agricultural biotechnology products since 2005. Pursuant 

to this ban, importers of agricultural products must present documents certifying that their goods 

do not include agricultural biotechnology products. However, there are limited exceptions to the 

ban. For example, grain from agricultural biotechnology‐derived varieties can be imported for 

food aid, but it must be milled or sterilized so as to render the grain incapable of germinating 

after arriving in the country. In addition, products of agricultural biotechnology imported for 

scientific research may be allowed, but subject to regulations and controls to be established by 

the various SADC Member States. In November, 2012, the United States held meetings 

regarding agricultural biotechnology and other innovative technologies. 

See section III.B for an explanation of the agricultural biotechnology trade issue.

SRI LANKA

Agricultural Biotechnology

Sri Lanka currently prohibits the sale of GE seeds or products containing GE organisms intended 

for human consumption without the approval of Sri Lanka’s Chief Food Authority. Sri Lanka 

does not appear to have a functioning approval mechanism, and thus in effect imposes a de facto 

ban on sales of seeds and other agricultural products derived from GE. Further, Sri Lanka 

 

7 The SADC is a 15-country socio-economic cooperation and integration group composed of Angola, Botswana, the 

Democratic Republic of the Congo, Lesotho, Madagascar, Malawi, Mauritius, Mozambique, Namibia, Seychelles, 

South Africa, Swaziland, Tanzania, Zambia, and Zimbabwe. 
78

requires all commodity imports to be accompanied by a certification that the commodity is “nonGE.” The United States will continue to engage Sri Lanka on these issues.

See section III.B for an explanation of the agricultural biotechnology trade issue.

Beef and Beef Products

Sri Lanka continues to ban all imports of U.S. bovine products, including beef, beef products, 

and beef genetics following the detection of a BSE-positive animal in the United States in 2003. 

The United States will continue to urge Sri Lanka to open its market fully to U.S. beef and beef 

products based on science, the OIE guidelines, and the United States’ risk status.

See section III.C for an explanation of the BSE trade issue.

SWITZERLAND

Agricultural Biotechnology

Switzerland has a burdensome and slow‐moving process for approving agricultural 

biotechnology products for food and feed use. In addition, in November 2005, Switzerland 

implemented a five‐year moratorium on approvals for the commercial cultivation of agricultural 

biotechnology crops. This moratorium has been extended by an act of Parliament until 

November 2013. U.S. officials will continue to urge their Swiss counterparts to address the 

cumbersome aspects of its regulatory review system and remove the moratorium on cultivation.

See section III.B for an explanation of the agricultural biotechnology trade issue.

TAIWAN 

Food Safety

Beef and Beef Products

Taiwan banned imports of U.S. beef and beef products following the detection of a BSE-positive 

animal in the United States in 2003. In 2006, Taiwan began allowing imports of U.S. deboned 

beef derived from animals under 30 months of age. In October 2009, the United States and 

Taiwan reached agreement on a Protocol expanding market access for U.S. beef and beef 

products (for human consumption) based on science, the OIE guidelines, and the United States’ 

controlled risk status. The Protocol defines the conditions for the exportation of U.S. beef and 

beef products to Taiwan and ultimately provides for a full re‐opening of the market.

However, after the Protocol entered into force in November 2009, Taiwan’s legislature adopted 

an amendment to Taiwan’s Food Sanitation Act in January 2010 that, in effect, banned imports 

of ground beef and certain offals and other beef products from the United States, contrary to 

Taiwan’s obligations under the Protocol. Moreover, Taiwan announced additional border 

measures, including a licensing scheme for permitted offal. Taiwan also imposed even stricter 
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inspection requirements for certain “sensitive” beef offals (e.g., tongue) that discourage imports 

of these products. 

The United States has raised these issues with Taiwan in various venues. At each opportunity, 

the United States has stated that it expects Taiwan to act consistently with its obligations under 

the Protocol. The United States will continue to urge Taiwan to open its market fully to U.S. 

beef and beef products based on science, the OIE guidelines, and the United States’ risk status.

See section III.C for an explanation of the BSE trade issue.

Ractopamine

In September 2012, Taiwan adopted and implemented an MRL for ractopamine in beef muscle 

cuts consistent with the Codex standard. However, Taiwan continues to delay the 

implementation of MRLs for ractopamine in other cattle derived products and for swine that it 

notified to the WTO in 2007. Taiwan’s lack of progress in adopting additional MRLs for pork 

has raised a significant trade concern by forcing U.S. pork producers to ship pork products 

selectively sourced from animals not treated with ractopamine. Since 2007, U.S. officials have 

raised this issue repeatedly at meetings of the WTO SPS Committee as well as in bilateral 

meetings with Taiwan, including meetings at the most senior levels. Taiwan authorities appear 

to have acknowledged in a number of public statements that trace amounts of ractopamine do not 

present a health risk. The United States continues to encourage Taiwan to implement the 

remaining proposed MRLs for ractopamine without further delay. 

Maximum Residue Limits for Pesticides

Taiwan’s slow and cumbersome process for adopting MRLs for pesticides has resulted in a 

substantial backlog of MRL applications and is creating a significant level of uncertainty within 

the U.S. agricultural export industry. Since 2006, this backlog has resulted in the rejection of 

various U.S. agricultural shipments (e.g., cherries, apples, wheat, barley, strawberries, potatoes, 

almonds, and corn) due to the detection of pesticide or other crop protection compound residue 

levels that are within U.S. or Codex standards, but for which Taiwan has not yet established 

MRLs.

While the United States is encouraged by Taiwan’s ongoing efforts to work through the backlog 

of MRL applications, shipments of U.S. agricultural products remain at risk of rejection due to 

the absence of MRLs for some commonly used pesticides, which have already undergone 

rigorous health and safety review in the United States. U.S. agricultural products that rely on 

newer, safer alternatives to older pesticides that are being phased out in the United States are 

particularly at risk of being rejected. 

The United States is working closely with U.S. stakeholders to gather appropriate data for 

technical engagement with Taiwan to facilitate Taiwan’s establishment of MRLs for these 

newer, safer compounds. The United States continues to engage with Taiwan to reach a solution.

See section III.E for an explanation of the MRL trade issue.
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Animal Health

Animal and Pet Feed

Taiwan bans the importation of all ruminant-origin ingredients (except milk, hide-derived gelatin 

and collagen, and dicalcium phosphate), as well as many non-ruminant-origin ingredients, 

intended for use in animal feeds and pet foods due to BSE-related concerns. Prohibited 

ingredients include protein-free tallow, bovine blood, bovine bone-derived gelatin, and all 

rendered meals regardless of species of origin (except hydrolyzed feather meal). Additionally, 

U.S.‐origin pet foods containing animal-origin ingredients other than those originating from 

milk, fish, hide-derived gelatin, dicalcium phosphate and/or collagen, exported to Taiwan must 

originate from U.S. facilities that have been inspected and approved by Taiwan’s Bureau of 

Animal and Plant Health Inspection and Quarantine. The approval process is lengthy, taking a 

minimum of 18 months to two years, and requires the facilities to submit extensive applications.

See section III.C for an explanation of the BSE trade issue.

Plant Health

Apples

Under the current export work plan for the shipment of U.S. apples to Taiwan, the Bureau of 

Animal and Plant Health Inspection and Quarantine (BAPHIQ) imposes a strict “three strikes” 

penalty structure for codling moth (CM) detections, where Taiwan will bar all imports of U.S. 

apples for the remainder of a shipping season if there are three confirmed detections of live 

CMs. APHIS and BAPHIQ have met on numerous occasions to discuss this issue and the work 

plan has been modified to include a 2-week grace period following each CM detection. This 

means that any CM detections that occur within the 2-week grace period do not count as an 

additional “strike.” However, each year the U.S. apple trade is faced with the possibility that the 

fourth largest market for U.S. apples may suddenly close, creating significant uncertainty among 

U.S. producers. U.S. apple exports to Taiwan totaled $85.0 million in calendar year 2012, about 

eight percent of total U.S. apple exports. 

In October 2006, APHIS provided Taiwan with research demonstrating that the risk associated 

with CM transmission and establishment in Taiwan via U.S.-origin apples is extremely 

low. This research document was used in discussions with Taiwan counterparts in 2011 as 

additional modifications to the current “three strikes” penalty structure were negotiated. APHIS 

will continue discussions with BAPHIQ on the technical aspects of coddling moth risk and 

modifications to the penalty structure of the work plan to eliminate the threat of market closure 

in 2013.

Potatoes

Taiwan currently limits imports of fresh potatoes from the United States to those grown in 

Alaska, California, Idaho, Oregon, and Washington. These restrictions exclude major producing 

states, including Colorado. In 2002, the United States requested that Taiwan add Colorado to the 
81

list of eligible states. In January 2013, Taiwan promulgated new regulations that should allow 

the importation of table stock potatoes from Colorado sometime in 2013.

THAILAND

Animal Health

Animal-Derived Products

Thailand bans the importation of most ruminant-origin products (including essentially BSE-risk 

free commodities, such as blood), and many non-ruminant origin commodities intended for use 

in pet foods or for livestock feed due to BSE-related concerns. Thailand also requires inspection 

and approval of U.S. manufacturing facilities that produce certain animal-derived products as a 

condition for approval for importation.

Food Safety

Beef and Beef Products

Thailand restricts the importation of U.S. beef and beef products due to the detection of a BSE 

positive animal in the United States in 2003. Currently, Thailand allows imports of U.S. 

deboned beef from animals under 30 months of age. In 2012, Thailand published new rules that 

bring it largely in line with OIE BSE guidelines. The United States will continue to urge 

Thailand to open its market fully to U.S. beef and beef products based on science, the OIE 

guidelines, and the United States’ risk status.

See section III C for an explanation of the BSE trade issue.

Ractopamine

In 2012, after the Codex established MRLs for ractopamine in cattle and pig tissues, Thailand 

indicated it would lift its ban on imports of pork from countries that allow the use of 

ractopamine. However, Thailand has not yet established MRLs for ractopamine in pork, which 

in effect continues to prevent imports of U.S. product. Thai officials indicated they will establish 

domestic MRLs by December 2013. The United States has encouraged Thailand to act quickly 

in this regard

Import Fees

Thailand imposes food safety inspection fees in the form of import permit fees on all shipments 

of uncooked meat. Current fees are $160 per ton for red meat (beef, buffalo, goat, lamb, and 

pork) and offals, and $320 per ton for poultry meat. Fees for domestic meat inspections, 

however, are significantly lower at $5 per ton for beef, $21 per ton for poultry, $16 per ton for 

pork, and zero for offals. The domestic fees are levied in the form of slaughtering or 

slaughterhouse fees. The United States will continue to press Thailand to equalize the fees and 

ensure that the import fees are commensurate with the services provided.
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TURKEY

Agricultural Biotechnology

In 2010, Turkey implemented a new, overarching Biosafety Law, which immediately negated the 

approvals of agricultural biotechnology products granted under Turkey’s previous biotechnology 

regulation and effectively stopped all trade in products derived from agricultural biotechnology 

(primarily soy and corn products). Turkey has indicated that it intends to follow EU practices in 

implementing the Biosafety Law and limit its review of agricultural biotechnology products, at 

least initially, to those already approved in the EU. In October 2010, Turkey’s Biosafety Board 

began an expedited review of three agricultural biotechnology soybean products grown in the 

United States and approved for import into the EU. The Board approved these products for feed 

use in January 2011. In March 2011, the Biosafety Board began non-expedited reviews of all 

other EU approved agricultural biotechnology products, including soy for food use; corn for food 

and feed use; and canola, sugar beets, and potatoes for feed use. In December, 2011, the 

Biosafety Board approved 13 agricultural biotechnology corn products for food use. In February 

2012, the Board approved three additional corn products, but rejected six others. Imports of U.S. 

corn will not resume until all petitioned products are approved, since all seed varieties are 

planted in the United States and consignments may contain any of these corn products due to the 

commodity handling system of the United States. The United States has submitted comments to 

Turkey on the Biosafety Board’s decisions and will continue to work with Turkey to obtain 

approvals for additional U.S. biotech products. 

In April 2011, Turkey’s Ministry of Agriculture and Rural Affairs (MARA) issued instructions 

to all port officials to begin testing imports for the presence of agricultural biotechnology 

products, including corn, soy, cotton, canola, sugar beets, potato, and tomato. This testing 

resulted in an immediate block of imports of U.S. cotton. Turkey subsequently allowed imports 

of U.S. cotton to resume, provided importers certified that the cotton does not contain living 

modified organisms.

In September 2011, Turkey adopted a measure that allows for up to 0.1percent presence in 

animal feed of agricultural biotechnology products that are under review or whose approval has 

expired. Such a low threshold has little practical value, and the United States continues to urge 

Turkey to increase the 0.1percent threshold and to extend the provision to food products.

The Biosafety Law also does not allow biotechnology products and by-products to be used in 

industrial goods. In 2011, Turkey began blocking the use of soybean oil produced from 

imported soybeans in the production of paint and other industrial goods. Following U.S. 

embassy-hosted educational seminars on the industrial use of agricultural biotechnology 

materials, Turkey issued an order allowing soybean oil to be used in the paint sector, but 

continued to bar all other uses in industrial products.

Under the Biosafety Law, MARA has pressed agricultural biotechnology developers to apply for 

approval of their products. However, developers have been reluctant to do so because a number 

of essential details of the approval process remain unclear, including what may constitute a 

failure of compliance and, in situations of noncompliance, what level and kind of penalties will 
83

apply. In September 2011, U.S. and Turkish industry representatives began a dialogue with 

MARA to discuss these concerns, but these discussions have failed to resolve the industry’s 

concerns. 

The United States has repeatedly raised concerns about specific provisions of the 2010 Biosafety 

Law and its implementing regulations with Turkish officials, including at the June 2012 meeting 

under the bilateral Framework for Strategic Economic and Commercial Cooperation. In 

addition, the U.S. government and the U.S. agricultural industry have held a number of 

consultations with the Turkish government and Turkish industry, most recently in July 2012, 

about agricultural biotechnology and the agricultural biotechnology‐derived products affected by 

this law and implementing regulations. The United States will continue to engage Turkey on this 

issue both bilaterally and in multilateral fora.

See section III.B for an explanation of the agricultural biotechnology trade issue.

Food Safety

Meat

Turkey prohibits imports of red meat from the United States. In September 2010, Turkey 

expressed its intention to engage in discussions on opening its market to U.S. beef and beef 

products, plus cattle and sheep. However, Turkey’s proposed import conditions appear to 

deviate from OIE guidelines for BSE. In September 2010, Turkey allowed the imports of sheep 

and goats for breeding and production, and in March 2012 the United States and Turkey agreed 

upon language to finalize the export of breeding and fattening cattle to Turkey. The United 

States continues to work with Turkey to allow the export of live cattle for slaughter. The United 

States will continue to urge Turkey to open its market fully to U.S. live cattle for slaughtering,

beef, and beef products based on science, the OIE guidelines, and the United States’ risk status.

See section III.C for an explanation of the BSE trade issue.

UKRAINE

Agricultural Biotechnology

In 2007, Ukraine’s parliament enacted a law establishing a framework for the creation, testing, 

and use of products of agricultural biotechnology, but most of the implementing regulations 

necessary to open the market are still under development. In October 2010, Ukraine's Cabinet of 

Ministers approved a procedure for state registration of agricultural biotechnology events 

(ingredients) used in feed, feed additives, and veterinary drugs. Ukraine also recently issued a 

temporary approval of a soybean event to facilitate the importation of soy for animal feed. 

However, Ukraine continues to lack regulations permitting the use of approved agricultural 

biotechnology products for cultivation or import, which has led to unpredictable trade conditions 

for agricultural biotechnology derived food, feed, and seed products. 
84

In January 2011, Ukraine approved a list of food products that require testing and monitoring for 

agricultural biotechnology content. In February 2011, Ukraine approved a new law that uses 

scientific procedures for assessing the impact of GE organisms on the environment and provided 

the criteria that regulators would use to develop risk assessments. Starting in November 2011, 

and in accordance with legislation, Ukraine began testing all planting seed imports for GE 

presence at the zero level tolerance. Accordingly, any seed product with agricultural 

biotechnology presence is not legally allowed for commercial production or sale in the country, 

disrupting the food and seed industry operations in the Ukraine.

In 2012, Ukraine revised further its biosafety legislation and notified seven biotechnology 

regulations to the WTO. The United States submitted comments on these regulations, which 

raise concerns regarding the monitoring and routine detection testing of GE products. Currently,

the Ukrainian government ignores the illegal planting of agricultural biotechnology soy, 

rapeseed, and corn. 

The United States continues to work with Ukraine to establish a functioning and predictable 

agricultural biotechnology regulatory framework.

See section III.B for an explanation of the agricultural biotechnology trade issue.

Food Safety

Pork

Ukraine requires U.S. pork to be shipped frozen or tested for trichinosis. Ukraine’s testing 

requirement is costly and is a significant impediment to U.S. fresh/chilled pork exports to 

Ukraine. The United States does not consider such requirements to be necessary because U.S. 

producers maintain stringent biosecurity protocols that limit the appearance of trichinae in the 

United States to extremely low levels. The United States will work with regulatory authorities in 

Ukraine to resolve this trade concern. 

URUGUAY

Food Safety

Live Cattle, Beef, and Beef Products

Uruguay continues to ban imports of all U.S. live cattle, beef, and beef products following the 

detection of a BSE-positive animal in the United States in 2003. The United States will continue 

to urge Uruguay to open its market fully to U.S. live cattle, beef, and beef products based on 

science, the OIE guidelines, and the United States’ risk status.

See section III.C for an explanation of the BSE trade issue.
85

Animal Health

Poultry 

Uruguay currently bans imports of many U.S. poultry products due to concerns over AI and 

Newcastle’s disease. In October 2007, the United States and Uruguay reached an agreement that 

permitted imports of U.S. turkey to resume. The U.S. acceptance of this agreement, however, 

was premised on the understanding that the two countries would complete negotiations to 

provide market access for all poultry and poultry products, consistent with science and the 

relevant OIE guidelines. The United States has raised the issue with Uruguay repeatedly, 

including at the October 2011 Trade and Investment Council meeting.

Uruguay recently completed its Newcastle disease evaluation of the United States. The next step 

is for Uruguay to review the adequacy of the U.S. food safety system as it applies to poultry. 

The United States continues to engage with Uruguay on this issue to pave the way for U.S. 

poultry producers to export all their products to Uruguay.

Plant Health

Potatoes

Uruguay represents an important market for U.S. seed potatoes. In 2012, U.S. and Uruguayan 

technical agencies implemented an optional pre-sampling protocol for exporters of U.S. seed 

potatoes. Under this protocol, shipments are pre-screened to facilitate the agricultural inspection 

process at the Uruguayan ports-of-entry, which reduces the chances that U.S. shipments are 

delayed or rejected due to plant pest and disease concerns. Nevertheless, Uruguay’s tolerance 

level for a fungus that causes powdery scab remains a concern for U.S. exporters because it 

appears to be set inappropriately low. The United States will continue to work with Uruguay to 

address outstanding concerns relating to Uruguay’s existing tolerance levels. 

VIETNAM

General

Vietnam is working to ensure that its SPS regime is consistent with international standards. 

However, in April 2010, Vietnam proposed a series of SPS measures purportedly to address 

broad food safety concerns, but which appear to have unnecessarily restricted trade. The United 

States continues to urge Vietnam to adopt SPS measures consistent with international standards 

as they relate to the importation of meat and meat by‐products. 

In May 2006, the United States and Vietnam concluded an agreement in which Vietnam agreed 

to recognize the U.S. food safety and inspection systems for beef, pork, and poultry as equivalent 

to its own inspection system. Although granting equivalence was an important and welcome 

step that signaled Vietnam’s commitment to developing a science‐based system for furthering 

trade, Vietnam does not appear to have yet adopted other food safety standards promulgated by

international standard‐setting organizations, such as the OIE.
86

In April 2012, Vietnam issued Decree 38, an implementing regulation for its comprehensive 

Food Safety Law. Decree 38 is broad in scope, covering regulations for a wide variety of 

horticultural, seafood, and meat products and applies to foreign suppliers and domestic 

producers. The United States is concerned with Decree 38’s lack of transparency and its onerous 

conformity assessment procedure. The United States has raised this issue bilaterally with 

Vietnam on several occasions, including on the margins of TPP meetings and the WTO SPS 

Committee, and will continue to seek a successful resolution. 

Food Safety

Beef and Beef Products

During bilateral negotiations with the United States over its accession to the WTO, Vietnam 

agreed to allow imports of U.S. beef and beef products from cattle less than 30 months old. 

Since 2007, the United States and Vietnam have been negotiating animal health requirements to 

facilitate the trade in live cattle, beef, and beef products. In July 2011, the two sides agreed on 

requirements for the exporting live cattle to Vietnam. The United States will continue to urge 

Vietnam to open its market fully to U.S. beef and beef products based on science, the OIE 

guidelines, and the United States’ risk status.

See section III.C for a description of the BSE trade issue.

Offals

In July 2010, Vietnam implemented a “temporary ban” on the importation of offal products from 

all countries. Vietnam claimed there were food safety concerns that justified implementing the 

ban, but, to date, has provided no scientific data to the WTO or any trading partner to support 

this allegation. In April 2011, Vietnam’s Ministry of Agriculture and Rural Development 

partially lifted the ban by allowing imports of pork and poultry hearts, livers and kidneys (what 

Vietnam describe as “red offals”). In May 2011, Vietnam lifted the ban with respect to imports 

of bovine-origin hearts, livers and kidneys. However, all other offal products (or “white offals”) 

remain banned. 

The United States raised this issue at the June 2011 WTO SPS Committee meeting and was 

joined by numerous other WTO Members. In response, Vietnam indicated it would conduct a 

risk assessment to justify the remaining ban, but to date it has not shared any such risk 

assessment. The United States continues to engage with Vietnam on this issue.

Products of Animal Origin

In May 2010, Vietnam issued a new regulation, Circular 25, which outlines food hygiene and 

safety standards for imported foods of animal origin. The regulation requires producers to 

provide extensive information on their individual facilities in order for foods produced in those 

facilities to remain eligible for exportation to Vietnam. 
87

Vietnam has not updated its list of approved U.S. exporting establishments since August 2011, 

despite the fact that several U.S. producers have submitted the required application materials. 

The United States continues to work with Vietnam on resolving long term issues related to this 

regulation, including exporting company registration requirements and the need for a transparent 

and consistent review and approval process for new applicants.

Products of Plant Origin

In July 2011, Vietnam began enforcing new regulations on imported goods of plant origin. The 

United States has raised concerns regarding exporter registration requirements, sampling rates, 

and the coverage of MRLs. The United States will continue to work with Vietnam to address its 

concerns.

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V. TECHNICAL ASSISTANCE

The United States seeks to ensure that governments base their SPS measures on science and risk 

assessments and refrain from using SPS measures as disguised restrictions on international trade. 

To this end, the United States is committed to cooperating with trading partners on SPS issues 

and to providing technical assistance, where appropriate, to help other countries meet their 

international obligations and facilitate trade in agricultural products. To accomplish these goals, 

the United States has incorporated SPS objectives into a wide variety of bilateral cooperation and 

assistance programs. The technical assistance provided by the United States has helped many 

developing countries build their SPS regulatory infrastructure, which reduces food safety risks of 

products imported to the United States and opens new export markets for U.S. agricultural 

products. 

Article 9 of the SPS Agreement provides that “Members agree to facilitate the provision of 

technical assistance to other Members, especially developing country Members, either bilaterally 

or through the appropriate international organizations.” This type of assistance is intended to 

help Members comply with SPS measures in export markets. The SPS Agreement, however, 

does not address technical cooperation and assistance with respect to Members’ efforts to 

implement the SPS Agreement in their own markets. For this reason, Members have raised 

concerns in the SPS Committee about technical constraints affecting the ability of developing 

countries to comply with certain provisions of the SPS Agreement. In particular, some Members 

have noted the substantial technical and resource demands associated with quantitative or other 

advanced risk assessment techniques and have requested assistance to improve the capabilities of 

developing countries to conduct such assessments. The United States strongly supports 

increased technical cooperation and assistance, including efforts in APEC, and the STDF to 

improve the risk assessment capabilities of all Members. The STDF is a global partnership that 

supports developing countries in building their capacity to implement international SPS 

standards, guidelines, and recommendations as a means to improve their human, animal, and 

plant health status and ability to gain or maintain access to markets.

Trade Capacity Building

U.S. trade capacity building efforts in the SPS area seek to foster a clear understanding of key 

SPS provisions in international and bilateral trade agreements. Programs focus on the key 

requirement that SPS measures be supported by science, the fundamentals of risk assessment, 

and the most effective way to build and administer SPS regulatory programs. Forms of 

assistance include conducting regional trade capacity building workshops, conferences, hands-on 

training programs, mentorships, and site visits to U.S. research facilities.

The United States administers a number of programs to build expertise in foreign countries 

regarding agricultural biotechnology, food safety, animal health, and plant health. Fostering a 

cadre of specialists who support science-based health and safety measures improves the safety of 

products imported to the United States and facilitates transparent and predictable market access 

for U.S. exports. USDA and FDA implement many of these technical assistance activities in 

partnership with other U.S. government agencies, international organizations, U.S. universities, 
90

agribusinesses, and private consultants. This technical assistance not only increases developing 

country partners’ capacity to access the benefits of increased agricultural trade, but also builds 

understanding of the U.S. SPS regulatory system, provides the U.S. with key partners within 

ministries of agriculture, health, and trade, and allows the U.S. to promote the adoption of SPS 

measures that are harmonized with science-based international SPS standards. Harmonization 

with international standards reduces potential risks posed by imports from our partner countries 

to American consumers and American agriculture and allows for increased U.S. agricultural 

exports.

In response to new obligations under the U.S. Food Safety Modernization Act and an interest to 

prevent problems in the global food safety supply chain, FDA is working with new and existing 

partners to broaden the reach of food safety technical assistance and capacity building. One such 

example is its partnership with the Joint Institute for Food Safety and Applied Nutrition 

(JIFSAN) to provide food safety technical assistance. For laboratory capacity, JIFSAN created 

the International Food Safety Training Laboratory (IFSTL) in 2011 to deliver laboratory-based 

training to scientists suitable for monitoring food safety compliance. Additionally, JIFSAN 

conducts numerous food safety training programs on good agricultural practices, good 

aquaculture practices, risk assessment and commercially sterilized processed foods to the 

international community. Support for these activities is part of a long-term capacity-building 

program aimed at strengthening the safety of imports and strengthening the food safety systems 

of other countries, including the testing methods foreign government laboratories use to meet 

U.S. and international standards.

In fiscal year 2012, FDA coordinated and organized 84 visits for 381 foreign nationals from 

governments, industry, academia and the public sector, seeking to learn more about FDA’s food 

regulations and related food safety programs in order to meet U.S. food safety standards. 

Trade capacity building is one way that the U.S. Government seeks to ensure that foreign 

governments utilize SPS measures to enhance their food safety systems and do not use SPS 

measures to restrict trade. By supporting the adoption and effective implementation of sciencebased standards in other countries, the U.S. Government helps to enhance food safety systems 

globally, prevent problems in the global supply chain, lower unwarranted barriers to trade and 

expand market access for U.S. agricultural and food products.

The following section provides descriptions of U.S. technical assistance on SPS-related issues 

for various regions and countries. This list is not meant to be comprehensive, but highlights 

some of the most important activities in 2012.

Regional Activities

In 2012, USDA held regional workshops in Asia, Africa, Latin America, and the Caribbean for 

developing country delegates to various Codex committees. These workshops provided 

delegates with an opportunity to learn about the Codex process and improved understanding and 

support from many developing countries for science-based decisions in Codex committees. With 

greater participation of developing countries in international meetings, Codex decisions will 

better reflect the views of all of its members, while protecting consumers and facilitating trade. 
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USDA also is working with the STDF, the Association of Southeast Asian Nations, the African 

Union, IICA, and others to coordinate global pesticide residue field trials. These global 

partnerships are an outcome of USDA’s continuing program of providing technical assistance to 

developing countries in conducting pesticide field trials. The goal of these partnerships is to 

promote common pesticide MRLs to facilitate trade. Working with other countries to promote 

the use of common MRLs serves to minimize detention or rejection of U.S. exports at foreign 

ports of entry for residue violations, because there will be fewer instances when U.S. MRLs 

differ (either because the levels are different, or because those pesticides are not registered in the 

export market country) from those of its export markets. 

In the past year, USDA cooperated with the FDA, the U.S. Department of State, the Federal 

Bureau of Investigation, and U.S. university partners to conduct Food Defense International 

Awareness workshops in Argentina, Chile, Costa Rica, Guatemala, Israel, Jordan, Korea, and 

Turkey. Food defense is the protection of the food supply from intentional contamination. 

These workshops provided a forum for representatives of government and industry to discuss the 

challenges posed by the intentional contamination of the food supply and find cost-effective 

ways to address these challenges. They also provide a forum to discuss any new government 

regulations to help ensure that these regulations are based on scientific evidence and are 

harmonized among countries so as to cause the least amount of disruption to trade. 

USDA also invited and sponsored participants from various countries to attend U.S.-based 

courses in veterinary epidemiology, risk analysis, plant disease diagnostics, animal diseases, and 

laboratory diagnostic networks. USDA held these courses in various locations in the United 

States, including Fort Collins, Colorado; Plum Island, New York; Washington, DC; Ames, Iowa; 

and Madison, Wisconsin. Key SPS officials from developing countries attended the courses 

where they were able to increase their knowledge and receive a more in-depth understanding of 

the rationale and science behind the U.S. SPS regulatory system. This improved understanding 

promotes increased trust in the U.S. regulatory system on the part of key officials in other 

countries, helping to facilitate the export of U.S. food and agricultural products. 

USDA sponsored nineteen Cochran Fellows from Brazil, Dominica, Egypt, Guatemala, 

Honduras, Iraq, Jordan, Liberia, Malaysia, Paraguay, and Trinidad and Tobago to attend the 

FSIS Meat and Poultry Inspection Seminar for International Government Officials. This training 

familiarized foreign government officials with inspection regulations and procedures used by 

USDA to ensure that the nation's meat, poultry, and egg products are safe, wholesome, and 

properly labeled. The seminar covered a range of issues, including Hazard Analysis and Critical 

Control Points and pathogen reduction; animal production; import and export policies and 

procedures; the roles of FDA, state, and local inspection agencies; and field visits to import and 

export locations, and processing and slaughter plants. In addition to providing training to the 

Fellows, this program demonstrates the safety of U.S. products and facilitates port of entry 

procedures for U.S. exports. 

Additionally, USDA provided food safety training to ten Cochran Fellows from Algeria, Costa 

Rica, Ghana, Moldova, Nicaragua, Nigeria, and Ukraine at Michigan State University in 

Lansing, Michigan. The training program focused on emerging food safety issues and concepts, 
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U.S. and international food safety regulatory systems, food safety policy development, risk 

analysis, and food safety program implementation. By addressing food safety issues that present 

unjustified barriers to trade and that are increasingly tied to global trade agreements this USDA 

program promoted U.S. exports to these countries and helped build an international food safety 

resource network.

USDA sponsored and participated in five regional meetings, two each in Asia and Latin America 

and one in Africa, to provide information in advance of the 6th Conference of the Parties/Meeting 

of the Parties to the Cartagena Protocol on Biosafety (Protocol), which was held in fall 2012 in 

India. The regional meetings helped result in several key successes at the Protocol meetings 

including: 1) prevention of the adoption of a flawed risk assessment guidance document; 2) 

agreement that outcomes from two technical expert groups, one on risk assessment and the other 

on socio-economic considerations, will be brought back to the next Meeting of the Parties for 

consideration of next steps by all Parties; and 3) a call for Parties to notify their biosafety 

regulatory frameworks to the Biosafety Clearing-House.

Africa

USDA in cooperation with the U.S. Agency for International Development (USAID) continues 

to support four resident SPS advisors and coordinators stationed in Sub-Saharan Africa to cover 

the East, West, and Southern Africa regions. These SPS advisors and coordinators directly 

supported government SPS agencies in their respective regions to develop institutional capacity 

for establishing and maintaining science-based regulatory systems consistent with international 

standards.

An example of this support occurred when USDA collaborated with the OIE to provide technical 

information regarding the regulation of veterinary biologics in the United States to an assembled 

group of African government veterinary officials. This seminar occurred in Kenya and provided 

participants with information on the OIE activities linked to veterinary products, the 

responsibilities of OIE delegates and their national veterinary officials, the rights and obligations 

of OIE Members in trade, and on several other issues relevant for the production and use of 

veterinary products.

In support of science-based regulatory frameworks in Africa, USDA also provided financial 

support to the Common Market for Eastern and Southern Africa’s (COMESA) regional 

workshop in Zambia in May 2012 and later attended the drafting session at which the COMESA 

Regional Biotechnology Framework (RABESA) was completed. The workshop helped solidify 

endorsement of the final draft of the RABESA by the delegates. This draft will be presented at 

the 2013 COMESA Joint Ministerial meeting for ratification by the COMESA Ministers of 

Agriculture, Environment and Natural Resources. This Framework should assist agricultural 

development and trade of GE products on a regional basis throughout East Africa. 

Asia Pacific Economic Cooperation

In November 2011, the United States pledged technical support for a new Global Food Safety 

Partnership (GFSP) between APEC and the World Bank. The GFSP is structured as a 
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collaborative, multi-stakeholder forum supported by a multi-donor trust fund (MDTF). The 

objective of the trust fund is to support training programs designed to enhance food safety and 

facilitate global food trade. A public-private partnership encompassing government institutions, 

private enterprises, producers, and other stakeholders is a fundamental component of the 

GFSP. The MDTF began with initial funding of $1 million by industry, which is expected to 

eventually grow to $15-20 million. The APEC region will serve as a pilot program for the work 

plan of the GFSP. The program will eventually be expanded globally to World Bank eligible 

economies. The GFSP will enhance U.S. efforts to facilitate the trade in safe food in the APEC 

region by coordinating technical training and sharing best practices so as to increase the capacity 

of APEC economies to implement international standards and use science and risk-based 

approaches to food safety regulation. These programs will also enable more growers, producers, 

and food safety officials to understand and use preventive controls, resulting in safer food for 

consumers and fewer safety incidents in food trade. 

Within the APEC Subcommittee on Standards and Conformance’s Food Safety Cooperation 

Forum’s Partnership Training Institute Network, USDA sponsored an Export Certification 

Workshop in Greenbelt, Maryland in April 2012. The event provided a forum for government 

and industry representatives from APEC member economies to discuss common issues and 

concerns related to export certificates. Discussions included a focus on Codex guidance and use 

of Codex model certificates, criteria for determining when a food or agricultural certificate 

should or should not be required, appropriate use of export certificate attestations, and increased 

use of electronic certificates. Also under the auspices of APEC, USDA sponsored sub-regional 

“Laboratory Competency Strengthening Workshops” in Kuala Lumpur, Malaysia; Lima, Peru; 

and Hanoi, Vietnam. The sub-regional trainings focused on analytical methods, validation, 

adaptation to local conditions, import-export trade facilitation methods, regulatory requirements, 

Codex principles, and good laboratory practices.

Latin America and the Caribbean

Since 2005, USDA has assisted the Dominican Republic-Central America-United States Free 

Trade Agreement (CAFTA-DR) countries in developing their institutional capacities to 

implement science-based regulatory systems consistent with international standards. The 

CAFTA-DR Trade Capacity Building Program includes SPS-related activities. Under this 

program, USDA helps CAFTA-DR countries develop their institutional capacities to implement 

science‐based regulatory systems consistent with international standards. Such systems create a 

more transparent, predictable, and favorable trade environment for U.S. exports. USDA bases its 

SPS assistance to CAFTA-DR countries on the national and regional needs identified during the 

CAFTA-DR negotiations and through the ongoing work of the CAFTA-DR Trade Capacity 

Building Committee. In FY 2012, USDA focused its efforts on increasing the capacity of other 

CAFTA-DR Parties to harmonize SPS standards regionally, establishing MRLs for pesticides, 

and meeting anticipated requirements for export to the United States. USDA conducted regional 

SPS workshops, pesticide laboratory training, pest risk assessment training, and fruit fly data 

collection training that helped lead to the establishment of an expert working group to address 

issues related to MRLs for specialty crops, and adopting common microbiological residue 

standards among Central American Customs Union countries. This harmonization support 
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improves trade flows within the region, and an increasingly integrated Central American market 

will assist in growing U.S. exports.

USDA’s Cochran Fellowship Program sponsored thirteen Fellows from Argentina, Costa Rica, 

Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, Panama, and Paraguay to 

attend FSIS Meat and Poultry Inspection training in Puerto Rico. The Fellows learned about 

U.S. inspection procedures and regulations used to ensure meat, poultry, and egg products are 

safe, wholesome, and properly labeled. The training helped create an understanding of U.S. 

regulations in foreign inspection offices with the goal of facilitating U.S. exports to the region. 

In 2012, USDA’s Cochran Fellowship Program and FSIS collaborated to train two government 

officials from Barbados, and St. Vincent and the Grenadines on food safety testing methods. The 

purpose of the seminar was to familiarize foreign government laboratory officials with testing 

methods and procedures used by FSIS to ensure that meat, poultry, and egg products are safe and 

wholesome. The training course was conducted at the FSIS Eastern Laboratory in Athens, 

Georgia, and covered many food testing issues, including general requirements for laboratory 

competence and methods for detecting major pathogens. This training helps to protect Latin 

American, Caribbean, and U.S. consumers from food safety risks.

Russia and Eastern Europe

USDA collaborates with the U.S. Department of State and the U.S. Department of Defense to 

provide animal health technical assistance to the countries of Armenia, Georgia, Kazakhstan, and 

Ukraine. USDA has focused this technical assistance on the diagnosis, detection, and response 

to highly infectious animal diseases to help these partner countries control diseases of economic 

importance. The technical assistance also allows the United States to address foreign animal 

diseases, such as African swine fever, which could be very damaging to U.S. livestock herds if 

ever introduced in the United States. In addition, the training builds trust and credibility with 

foreign partners regarding the U.S. animal health system. For example, the technical assistance 

provided to Kazakhstan regarding brucellosis, a highly contagious, infectious animal disease, 

promoted understanding of the use of vaccines in the United States and how this helped prevent 

the introduction of brucellosis in the United States. This assistance promotes the alignment of 

science-based systems and international standards to prevent disruptions in trade.

Country-Specific Activities

Bangladesh

In 2012, USDA’s Norman E. Borlaug Agricultural Science and Technology Fellowship Program 

sponsored a Fellow from Bangladesh studying food safety systems at the University of 

Nebraska-Lincoln. Over the twelve-week training period, the Borlaug Fellow became familiar 

with predictive modeling systems typically used in the United States and how these models can 

be used effectively for risk assessment in agricultural supply chains. This training provided the 

Fellow with improved skills, and knowledge of U.S. food safety models and technologies, which 

will lead to improved food safety in Bangladesh and promote U.S. exports.
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China

For the past five years, USDA has worked closely with EPA’s Office of Pesticide Programs to 

provide technical assistance to China’s Institute for the Control of Agri-Chemicals (ICAMA). 

These technical exchanges have resulted in a joint review by ICAMA and EPA of six chemicals 

that are approved for use in China and the United States, but are scheduled for re-evaluation. 

This cooperation between the United States and China benefits both countries and creates 

stability for exporters, as the chemicals available to U.S. farmers increasingly will be approved 

for use in China.

In November 2012, a team from Kansas State University travelled to China through the U.S.-

China Scientific Exchange Program to research factors affecting the control of PRRS in China. 

The goal of this exchange was to collaborate with Chinese researchers on efforts to minimize the 

global threat of Highly Pathogenic PRRS, a disease with the potential to threaten U.S. production 

and exports of U.S. pork to China.

Colombia

USDA initiated an SPS technical assistance project with Colombia in 2012. Initial technical 

assistance focused on strengthening Colombia’s pesticide registration process, but USDA 

expects to expand the project in 2013 to include strengthening Colombia’s plant health system in 

addition to providing technical assistance to develop and strengthen Colombia’s pesticide 

regulations. This project is an important platform for engaging with the Colombian government 

as the United States and Colombia implement the United States – Colombia Trade Promotion 

Agreement. This project promotes the use of the safer pesticides used by American producers 

and the reduction of food contamination, thus protecting public health. 

Mexico

In 2012, the United States provided SPS-related training to representatives from the Mexican 

government, industry, and academia on topics including animal vaccine development for beef 

(anaplasmosis) and poultry (avian influenza); agricultural biotechnology; laboratory analysis 

(emphasizing work with exotic Newcastle disease as well as general analytical methods and 

general validation and fitness for purpose); plant health risk analysis; meat and poultry product 

inspection; food defense, such as the molecular identification of the rice bacterial blight disease; 

and the diagnosis and control of paratuberculosis in dairy cattle, a disease that reduces milk 

production. 

In addition, FDA expanded laboratory cooperation with SENASICA and COFEPRIS 

laboratories in 2012, and continued participation in exchanges of information and methodologies 

for sampling, particularly with regard to microbiology and pesticide residues.
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Peru

USDA collaborated with FDA, EPA, and various U.S. university partners to provide SPS

capacity building to officials from Peru’s government and agricultural universities. This 

technical assistance focused on risk analysis, inspection and surveillance, laboratory diagnostics, 

SPS regulation development, and university curriculum development. This program aims to 

improve Peru’s ability to prevent contamination of its food supply and protect its agricultural 

sector from the spread of animal and plant diseases, and is part of the ongoing provision of 

technical assistance to Peru under the United States – Peru Trade Promotion Agreement. The 

training also aims to harmonize Peru’s SPS regulations with international standards to facilitate 

trade. An example of this occurred this past year when Peru updated its Pest Risk Assessment 

Protocols and Inspection Regulations. 

Vietnam

USDA sponsored seven Cochran Fellows from Vietnam to attend a Food Safety Systems training 

program conducted by North Carolina State University in August 2012. The training program 

was designed to inform Fellows of the science behind the U.S. food safety system for raw and 

processed plant products. The training included discussions on the alignment of science-based 

systems and international standards and visits to fruit production areas, vegetable processing 

facilities, and extension offices in North Carolina. The Fellows also met with APHIS, EPA, and 

Grain Inspection, Packers & Stockyards Administration. The goal of this training was to provide 

the Fellows with a greater understanding of the U.S. regulatory system and increase U.S. exports 

of fruits and vegetables to Vietnam.
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APPENDIX

USTR received public comments regarding this report from the following entities:

Almond Board of California

American Feed Industry Association

American Forest and Paper Association

American Potato Trade Alliance

American Soybean Association

California Grape and Tree Fruit League

California Table Grape Commission

Distilled Spirits Council of the United States

Grocery Manufacturers Association

Herbalife International of America

National Cattlemen’s Beef Association

National Confectioners Association

National Fisheries Institute

National Milk Producers Federation & U.S. Dairy Export Council

National Pork Producers Council

National Potato Council

National Renderers Association

North American Export Grain Association

Northwest Horticultural Council

U.S. Hop Industry Plant Protection Committee

U.S. Meat Export Federation

U.S. Wheat Associates

USA Rice Federation

Yum! Restaurants International
OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE

EXECUTIVE OFFICE OF THE PRESIDENT

WASHINGTON, D.C. 20508