WORLD TRADE
ORGANIZATIONG/SPS/GEN/212
7 November 2000
(00-4697)
Committee on Sanitary and Phytosanitary Measures Original:  English
EQUIVALENCE
Submission from the United States
1. In response to the Committee’s agreement to discuss Article 4 of the Agreement on the
Application of Sanitary and Phytosanitary Measures at its November 2000 meeting, the United States
submits this paper regarding Article 4.  This paper describes the experiences of the United States
regarding the practical implementation of the provisions of Article 4.  It should be noted that theUnited States has few equivalence agreements in effect at this time.  This is, in part, due to the
resource commitments needed and the difficulty of pursuing these kinds of agreements.  Nonetheless,
the experience of the United States may be of interest to the Committee during the discussion of this
issue.
Article 4 states:
1.  Members shall accept the sanitary or phytosanitary measures of other Members as
equivalent, even if these measures differ from their own or from those used by other Members
trading in the same product, if the exporting Member objectively demonstrates to the
importing Member that its measures achieve the importing Member’s appropriate level of
sanitary or phytosanitary protection.  For this purpose, reasonable access shall be given,upon request, to the importing Member for inspection, testing and other relevant procedures.
2. Members shall, upon request, enter into consultations with the aim of achieving
bilateral and multilateral agreements on recognition of the equivalence of specified sanitary
or phytosanitary measures.
US Approach
2. The United States, in its approach towards implementing the concept of equivalence,
recognizes that SPS measures of other Members may achieve the appropriate levels of protection(ALOP) of the United States.  In the United States, several different agencies develop and administer
SPS measures which achieve the ALOPs that are gene rally established by different statutes for food
safety and animal and plant health. The responsible US agency will determine another Member’s SPS
measures equivalent if they achieve the relevant ALOP.G/SPS/GEN/212
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3. With regard to food safety measures, three different federal agencies have  responsibility:
(1) the Department of Health and Human Servi ces’ Food and Drug Administration (FDA);  (2) the
Department of Agriculture’s Food Safety and Insp ection Service (FSIS);  and (3) the Environmental
Protection Agency (EPA).   FDA has primary respon sibility for the safety of all foods, with the
exception of meat, poultry, and certain egg products, which FSIS regulates.  EPA regulates the use ofpesticides and establishes maximum residue limits in foods that are enforced for domestically
produced and imported foods by FDA and FSIS.  US food safety laws are contained in several key
statutes.
1  US laws pertaining to the safety of meat and poultry differ from those pertaining to the
safety of other foods.
4. In regard to measures applied to protect plant and animal health, the Department of
Agriculture’s Animal and Plant Health Inspection Service (APHIS) has regulatory responsibility for
determining whether the exporting country’s measures meet the ALOP of the United States.
Foods  (except meat and poultry)
5. Under US law, most fresh and processed foods falling within FDA's regulatory authority may
be exported to the United States without any prior FDA approval or authorization.  There are a few
exceptions, most notably infant formula and low-acid/acidified canned foods, which are subject toprior registration of both US and foreign production facilities and certain other requirements, as
preconditions for distribution within the United States.  All foods marketed in the United States,
whether domestically produced or imported, are expected to meet FDA safety and labeling
requirements.  It is primarily the responsibility of food manufacturers to meet these requirements.  If
food products do not conform to these requirements, FDA takes the appropriate enforcement actionsto remove these products from the market in accordance with the laws of the United States.
6. An FDA finding of equivalence is not a prerequisite for export of foods to the United States.
Neither does FDA require consignment-specific "health" or "compliance" certificates be provided
from governments of countries exporting foods to the United States.  Nonetheless, some WTO
Members have requested equivalence determinations from the FDA.  Generally, however, theserequests are not addressing an actual trade barrier.
7. FDA’s equivalence determination process requires a review of relevant laws, regulations,
directives and practices and on-site verification of the competent authority’s administration of the
program or product under consideration.  The FDA pr ocedures are similar to those of FSIS, described
below.
Meat and Poultry
8. Laws of the United States governing meat and poultry inspection require an equivalence
determination before these products can be imported into the United States.  FSIS does not enter into
equivalence agreements with countries, but rather, at the completion of the equivalence determination
process, changes US regulations to list the country as eligible to export to the United States. FSIS has
developed and published a process for evaluating whether a foreign country’s meat and poultryregulatory system and individual sanitary measures are equivalent to the system and measures of the
United States.  Before implementing it in1999 , the proposed process was notified to the public.
                                                     
1 The Federal Food, Drug, and Cosmetic Act;  the Public Health Service Act;  the Federal Meat
Inspection Act;  the Poultry Products Inspection Act;  Egg Products Inspection Act;  and the Federal Insecticide,
Fungicide, and Rodenticide Act.G/SPS/GEN/212
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9. Applications from foreign countries for an initial determination of equivalence must contain
sufficient technical and scientific evidence for FSIS to evaluate whether sanitary measures of the
foreign food regulatory system are equivalent to the system of the United States.  To facilitate this
process, FSIS provides questionnaires to countries.  Completed questionnaires, along with copies of
laws, regulations and directives, provide the documentation needed by FSIS to make an equivalencedetermination.  The document review is generally the lengthiest part of the equivalence process.  Once
the document review process is completed, FSIS conducts an on-site audit to verify the equivalence of
the country’s inspection system.
10. When a country becomes eligible to export meat and poultry to the United States, FSIS
verifies its continued equivalence through random sampling of products for reinspection at the port of
entry and through annual on-site system audits.  Results of reinspections and audits are shared with
the exporting country.  There are currently 36 countries recognized as having meat and poultryinspections systems equivalent to the United States.  All meat and poultry products, domestic and
imported, marketed in the United States are expected  to be in compliance with  standards of the
United States.  If these food products are not to be in compliance, appropriate actions are taken to
remove the products from the market in accordance with the laws of the United States.
11. A similar process - document review and on-site verification - is used when a country eligible
to export to the United States requests an eq uivalence determination for an alternative sanitary
measure.  Alternative measures are raised independently by meat and poultry exporting countries in
the form of proposed changes in their inspections sy stems or they may be offered in response to new
inspection requirements of the United States.
Plants, Plant Products, Animals and Animal Products
12. APHIS applies the concept of equivalence in determining that an alternative measure or
combination of measures, proposed by the exporting country, achieves APHIS' objective of reducing a
given pest or disease risk to an acceptable level.  Different measures can, under certain circumstances,
achieve a comparable or identical level of protection against certain pest or disease risks.  Generally,APHIS evaluates a number of risk mitigation measures in determining the conditions under which
trade can be allowed.  For example, APHIS may generally require fumigation of imported fruits in
order to reduce the risk of introducing exotic fruit flies.  However, the exporting country may be able
to demonstrate that an alternative measure, such as cold treatment, or a combination of measures
under a systems approach, is equally effective in reducing the pest risk.
13. In accordance with Article 4, it is the responsibility of the exporting country to supply data
demonstrating the efficacy of the proposed measures to APHIS, and to permit APHIS to conductappropriate testing, inspection and other relevant procedures to assure the effectiveness of these
measures.
Practical Challenges with Article 4
14. In the experience of the United States, practical implementation of the concept of equivalence
is dependent upon a variety of factors, including:
• the scope (single product or product sector);
• the formality of any agreement reached between the parties, i.e., ranging from a
simple exchange of letters to a formal memorandum of understanding; and
• the number of parties involved, i.e.,  bilateral or multilateral.G/SPS/GEN/212
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15. Based on US experience, there are several practical problems that could limit the use of
Article 4.  Among these problems are:  (1) where no trade barrier exists, should the request for
equivalence be pursued;  (2) whether the actual trade benefits justify the administrative burden of
making a determination of equivalence and/or negotiating an agreement;  (3) the inherent difficulty
linking numerous and disparate measures to a country’s ALOP;  and (4) stakeholder acceptance ofequivalence determinations and negotiated equivalence agreements.
16. Possibly the most important factor constraining the use of Article 4 is that the practical gains
in product trade from an equivalence determination and any associated agreement may not be viewed
as worth the costs of reaching such a determination or agreement.  In the experience of the United
States, conducting equivalence evaluations and negotiating equivalence agreements involves a
substantial commitment of technical and trade specia lists to review materials, exchange data and
information, establish terms and conditions of discussions, meet with counterparts, and to conduct on-site visits and verification audits.
17. A second factor is the inherent difficulty associated with linking measures to a country’s
appropriate level of protection. This problem is magnified when the scope of the agreement is
broadened to include multiple products and the concept of equivalence as applied to import and export
control and inspection systems.
18. Another complicating factor is addressing stakeholder concerns.   It is critical that Members
take every appropriate opportunity to inform stakeholders about their on-going and intended
equivalence discussions with other Members to ensure stakeholder acceptance.  The use of an open,
public forum, which respects the need for direct government-to-government negotiations, appears to
be an excellent tool to facilitate consideration of the merit of seeking an equivalence determination or
agreement for particular products.
Conclusions Based on the Experience of the United States
19. Members should not regard an equivalence agreement as a necessary condition to gain access
to another member’s market.
Over 85 percent of all food products imported into the United States do not require a prior
determination of equivalence and/or an export certificate.  Meat and poultry products are
the primary exceptions and are based on legislative and regulatory requirements.  A
country must obtain an equivalence determination process before it can export meat or
poultry to the United States.
20. Utilization of other provisions of the SPS Agreement, specifically Article 5 (Risk
Assessment),  Article 7 and Annex B (Transparency), Article 8 and Annex C (Control, Inspection and
Approval Procedures), and Article 9 (Technical Assistance), prior to a request for formal equivalence
consultations may yield more immediate trade benefits.
WTO Members can request an explanation for the rationale for a specific measure in
accordance with Article 5.8.  Similarly, Members can request answers to all reasonablequestions and the provision of documents regarding a country’s existing and proposed
measures under Article 7 and Annex B.  Moreover, importing Members have additional
obligations in accordance with Article 8 and Annex C to assure that their approval
procedures are "undertaken and completed without undue delay" and that a procedure
exists to review complaints and take corrective actions when a complaint is justified.Finally, developing countries may benefit more directly by requesting product-specific
technical assistance in accordance with Article 9 in order "to adjust to, and comply with,G/SPS/GEN/212
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sanitary or phytosanitary measures necessary to achieve the appropriate level of sanitary
or phytosanitary protection in their export markets."
21. The "consultations" mentioned in Article 4.2 require a considerable investment in time and
other resources from both technical and trade officials.
Equivalence determinations require a signifi cant investment of technical and trade experts
to address and resolve safety issues  Even in instances where ALOPs and governmental
institutions of two WTO Members may appear to be similar, determinations of equivalence
have taken several years of negotiations and a great deal of the time of technical and trade
experts and have not resulted in immediate new trade opportunities.
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