Equivalence Evaluation Process for Foreign Meat and Poultry Food Regulatory Systems; Response to Comments

[Federal Register Volume 64, Number 242 (Friday, December 17, 1999)]
[Notices]
[Pages 70690-70693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-32551]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service
[Docket No. 99-052N]


Equivalence Evaluation Process for Foreign Meat and Poultry Food 
Regulatory Systems; Response to Comments

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice, response to comments.

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SUMMARY: The Food Safety and Inspection Service (FSIS) published a 
notice in the Federal Register of March 12, 1999 (64 F.R. 12281) 
announcing the availability of a document that describes the Agency's 
process for evaluating foreign meat and poultry inspection systems to 
determine whether they are equivalent to the United States' inspection 
system. FSIS solicited public comments on this document and held a 
public meeting on April 14, 1999, to discuss the equivalence evaluation 
process. The comment period ended May 11, 1999. This notice responds to 
the comments received from the public.

ADDRESSES: Copies of the comments are available from the FSIS Docket 
Clerk, Room 102 Cotton Annex, 300 12th Street, SW, Washington, DC 
20250-3700.

FOR FURTHER INFORMATION CONTACT: Mr. Clark Danford, Acting Director, 
International Policy Division; Office of Policy, Program Development, 
and Evaluation; (202) 720-6400, or by electronic mail to 
clark.danford@usda.gov.

SUPPLEMENTARY INFORMATION:

Background

    The equivalence concept was introduced in the Agreement on the 
Application of Sanitary and Phytosanitary Measures (the ``SPS 
Agreement''), which appears in the Final Act of the Uruguay Round of 
Multilateral Trade Negotiations signed in Marrakech on April 15, 1994. 
The SPS Agreement became effective in January 1995, concurrently with 
establishment of the World Trade Organization (WTO), which superseded 
the General Agreement on Tariffs and Trade (GATT) as the umbrella 
organization for international trade. The United States is a signatory 
to the SPS Agreement and is a member of the WTO.
    Under Article 4 of the SPS Agreement, an importing member nation 
must accept an exporting member's SPS measures as equivalent to its own 
measures if the exporting member has objectively demonstrated that its 
measures achieve the importing member's appropriate level of sanitary 
or phytosanitary protection (ALOP). In other words, each member nation 
of the WTO, including the United States, must accept as equivalent to 
its own food regulatory system the food regulatory system of another 
member that has been demonstrated to furnish the same level of public 
health protection. However, the burden of demonstrating equivalence is 
on the exporting country.
    Equivalent regulatory systems need not be identical. The specific 
SPS measures applied by an exporting nation may differ from those 
required by an importing nation. On the other hand, though WTO members 
are encouraged to adopt international food standards in order to 
``harmonize'' the world's food regulatory systems and facilitate trade, 
an importing country has the right to decide whether a food regulatory 
system employed by an exporting country is equivalent to its own or is 
adequate to achieve the importing country's appropriate level of 
sanitary or phytosanitary protection. The importing country also has 
the right to decide whether the evidence provided to demonstrate 
equivalence is adequate.

FSIS Equivalence Evaluation Process

    FSIS has developed a process for evaluating whether a foreign 
country's meat and poultry food regulatory system and specific sanitary 
measures are equivalent to the U.S. system and measures. This process 
is described in a January 1999 document entitled ``FSIS Process for 
Evaluating the Equivalence of Foreign Meat and Poultry Regulatory 
Systems'' (hereafter cited as ``FSIS Process''). Copies of this 
document are available at the location indicated above in ADDRESSES. An 
electronic copy may be found at the following Internet address 
www.fsis.usda.gov/oa/news/equiv.htm.
    FSIS published a notice in the Federal Register of March 12, 1999 
(64 F.R. 12281) announcing the availability of this document and 
soliciting public comments. The Agency also held a public meeting on 
April 14, 1999, to discuss the equivalence evaluation process. FSIS 
announced that the comments received would be the basis for further 
development of this Agency's equivalence evaluation process. The 
substance of those comments and FSIS responses follows.

Response to Comments

    The Federal Register notice comment period closed on May 11, 1999. 
Four organizations commented. Following is a summary of themes 
presented in the public comments and responses from FSIS.
    One commenter expressed support for the FSIS equivalence evaluation 
process with a caveat that prior notification of which establishments 
FSIS will visit during a system audit allows establishments to alter 
their processes and procedures in preparation for the visit and to 
revert to ``normal'' operations thereafter. This commenter recommended 
that establishment audits be unannounced.
    FSIS responds that foreign inspection system audits are, by 
necessity, cooperative events. For example, FSIS must first request 
permission from a

[[Page 70691]]

foreign government to visit the country and conduct an audit. FSIS is 
obliged to provide a proposed itinerary with its request. This is 
necessary, in part, because FSIS is a guest in the foreign country and 
is escorted from place to place by foreign officials. The same process 
is applied in the United States when a foreign government asks to visit 
U.S. establishments. Additionally, the U.S. system of prior 
notification is modeled on draft Codex guidelines titled ``Draft 
Guidelines for the Design, Operation, Assessment and Accreditation of 
Food Import and Export Inspection and Certification Systems'' which 
have been advanced to Step 8 of the approval procedure (ALINORM 97/30A, 
Appendix II, Annex).
    A second commenter emphasized the necessity for a ``level playing 
field'' in that inspection procedures in countries that export to the 
United States must be as effective as U.S. domestic programs. This 
commenter found the ``FSIS Process'' document to accurately portray SPS 
Agreement principles and applauded FSIS for being ``out front'' in 
international equivalence implementation. The commenter said that, 
while the document analysis portion of this process is important, the 
challenge is to verify foreign inspection systems and individual 
sanitary measures by on-site audits. The commenter noted that during 
times of budget stress FSIS managers may be tempted to cut back on 
system audits to less often than once a year. The commenter stated that 
this must not happen--that FSIS is obligated to conduct system audits 
at least annually in all exporting countries and share the results 
quarterly with public stakeholders. In a related matter, the commenter 
believed that the ``FSIS Process'' section on Initial System 
Equivalence did not clearly state what initial audits evaluate and 
requested further clarification. Finally, this commenter said that 
reference to animal disease issues should be lifted from footnote 1 and 
included in the body of the document to emphasize the important 
coordination between FSIS and the Animal and Plant Health Inspection 
Service on applications for eligibility.
    FSIS responds with a pledge that budget priority will be given to 
support annual system audits in all exporting countries. With regard to 
what FSIS evaluates during initial audits of foreign inspections 
systems, these criteria are regulatory and set forth in 9 CFR 327.2, 
Eligibility of foreign countries for importation of products into the 
United States. The same criteria apply to poultry importation and 
appear at 9 CFR 381.196. The next version of ``FSIS Process'' will 
incorporate a summary of these criteria. Additionally, the Agency will 
incorporate most of the editorial changes suggested by this commenter 
in the next revision of ``FSIS Process,'' which will be made in the 
Spring of 2000 and posted on the FSIS homepage. At that time FSIS will 
also begin posting foreign inspection system audit results on the FSIS 
homepage.
    A third commenter noted that FSIS has appropriately recognized the 
U.S. commitment to equivalence under the SPS Agreement and said that 
the ``FSIS Process'' document affirms that commitment. The commenter 
stated that the principles of equivalence will help to enhance food 
safety globally as other nations strive to attain the U.S. level of 
protection necessary for market access. The commenter commended FSIS 
for consistency with Codex work, stating that it is appropriate to 
incorporate Codex guidelines within U.S. standards where suitable. The 
commenter also voiced support for the concept of Food Safety Objective 
(FSO) as a bridge to describe how sanitary measures attain an importing 
country's level of protection. The commenter noted that ``FSIS 
Process'' contains an excellent description of FSO work underway in 
Codex and generally praised the transparent manner that FSIS is 
proceeding with its equivalence evaluation process. However, this 
commenter also advised that some aspects of ``FSIS Process'' needed 
improvement. For example, the commenter did not find the process 
document adequate to provide sufficient operational guidance to assist 
the United States' trading partners in the submission of an equivalence 
request. The commenter recommended that FSIS add to ``FSIS Process'' 
the detailed information it presented at the April 14 public meeting. 
Several editing changes were also suggested in other portions of the 
``FSIS Process'' document.
    FSIS responds that this commenter's suggestions for a revision of 
``FSIS Process'' were thoughtful and useful. The next revision of 
``FSIS Process'' will include the material suggested by the commenter, 
including guidance on information that should be included in an 
equivalence request.
    A fourth commenter found considerable fault with the ``FSIS 
Process'' document. This commenter stated that FSIS should correct 
misstatements in ``FSIS Process'' that assert the equivalence of all 
countries that now export to the U.S. because FSIS has not verified 
that all of these countries have implemented equivalent PR/HACCP 
sanitary measures. The commenter recommended that FSIS amend its 
regulations to provide for public participation in all determinations 
of foreign inspection system equivalence. This commenter also said that 
FSIS should correct a misstatement in ``FSIS Process'' that asserts 
that a country can set any level of protection it deems appropriate 
because, under SPS, the level of protection must be based on scientific 
evidence of risk.
    FSIS responds that every country presently eligible to export meat 
or poultry products to the United States has a food inspection system 
that is equivalent to the FSIS domestic inspection system. This agency 
is committed to protecting the health of U.S. consumers, and it will 
continue to make every effort to ensure that meat, poultry, and egg 
products imported into the United States are as safe as products 
produced in this country.
    Prior to the World Trade Organization (WTO) Agreement on Sanitary 
and Phytosanitary measures (commonly referred to as the ``SPS 
Agreement''), FSIS evaluated foreign food regulatory systems under 
provisions in U.S. inspection laws that required programs to be ``at 
least equal to'' the U.S. system. The eligibility of countries to 
export meat or poultry to the United States was initially evaluated 
through analysis of applications followed by on-site audits. When the 
SPS Agreement was ratified in 1994, all ``at least equal to'' countries 
that were eligible to export meat or poultry to the United States were 
automatically judged to be ``equivalent.''
    The SPS Agreement obliges the United States to respond to requests 
by other contracting parties to determine whether specified meat and 
poultry processing sanitary measures are equivalent to those of the 
United States. Alternative sanitary measures may be raised 
independently by exporting countries in the form of proposed foreign 
inspection system changes, or they may be offered in response to new 
U.S. import requirements.
    All alternative sanitary measures are evaluated by FSIS against two 
generic criteria:
    (1) Does the alternative sanitary measure comport with USDA 
regulatory requirements for the import of meat and poultry products to 
the United States? and (2) Does the alternative sanitary measure afford 
American consumers the same level of public health protection as is 
provided by USDA domestic measures?
    Each of the thirty-six countries that are presently permitted to 
export meat or poultry products to the United States

[[Page 70692]]

has a food regulatory system that FSIS has determined to be equivalent 
to the US inspection system. From this baseline of equivalence, FSIS 
has sought to ensure that equivalence is maintained. For example, when 
FSIS implements new sanitary measures domestically-such as the Pathogen 
Reduction/HACCP final rule-notice is given to each exporting country 
that the new measures must be adopted by the foreign food regulatory 
system in either the same way or in an equivalent manner. Exporting 
countries are asked first to provide FSIS written assurance that the 
new requirement will be implemented and second to submit documentary 
evidence to support equivalence. FSIS reviews this documentation on a 
country-by-country basis and makes a determination of whether the 
foreign country's measure appears to be equivalent. During the next on-
site foreign inspection system audit, the implementation of that 
measure is verified.
    There is no reason to stop trade with exporting countries while the 
document analysis and verification process is underway. Consumers are 
fully protected because FSIS will interrupt trade in three 
circumstances. One is where an emergency sanitary measure is 
implemented by FSIS to address a hazard that is so severe that no 
product can enter the marketplace from a foreign establishment until 
the control is in place. The second is where an exporting country does 
not provide satisfactory documentary evidence of an equivalent sanitary 
measure. The third is where a system audit reveals that an exporting 
country is not implementing a sanitary measure in the manner that FSIS 
initially determined to be equivalent.
    In the case of FSIS' Pathogen Reduction/HACCP sanitary measures, 
the first circumstance does not apply because none of the requirements 
are of an emergency nature. Thus, FSIS has proceeded to evaluate from 
each exporting country documentation that explains the country's method 
of implementing PR/HACCP sanitary measures. On-site verification is 
proceeding as well.
    FSIS has sought public participation in the equivalence 
verification process through the publication of ``FSIS Process'' along 
with the public meeting held on April 14, 1999, and this Federal 
Register notice. FSIS will provide for additional participation 
periodically about foreign inspection system equivalence verification 
audit results, port-of-entry reinspection results, and other notices of 
significant events regarding equivalence. In particular, FSIS will host 
a public meeting on December 14, 1999, to report completion of document 
analyses to evaluate the equivalence of foreign countries with USDA's 
Pathogen Reduction/HACCP final rule requirements. For further 
information, see FSIS Notice 99-051N, dated November 24, 1999 [64 FR 
66164].
    A central purpose of ``FSIS Process'' is to apprise the public of 
how FSIS is carrying out the day-to-day business of equivalence 
evaluations. FSIS believes that all routine equivalence determinations 
are being made in a sound and wholly transparent manner.
    In the case of a new application for eligibility, FSIS generally 
begins with little or no knowledge of the foreign food regulatory 
system. After extensive document analysis and an onsite system audit, 
FSIS notifies the public of an impending equivalence determination and 
allows time for comment. This process provides maximum assurance that a 
new exporting country is equivalent.
    Once the initial equivalence determination is made, FSIS follows 
the procedures set forth in ``FSIS Process'' to ensure that equivalence 
is maintained. FSIS pledges to conduct its equivalence activities in a 
fully transparent manner and will continue to advise and involve the 
public in its equivalence work.
    FSIS attempted in its ``FSIS Process'' document to explain ``level 
of protection'' (LOP) by using a quote from the Administrative Action 
Statement accompanying ``The Uruguay Round Agreements Act,'' (P.L. 103-
465; December 8, 1994), as follows:
    ``The [SPS] Agreement explicitly affirms the right of each 
government to choose its levels of protection, including a 'zero risk' 
level if it so chooses. A government may establish its levels of 
protection by any means available under its law, including by 
referendum. In the end, the choice of the appropriate level of 
protection is a societal value judgment. The Agreement imposes no 
requirement to establish a scientific basis for the chosen level of 
protection because the choice is not a scientific judgment.'' 
[Administrative Action Statement accompanying ``The Uruguay Round 
Agreements Act,'' (P.L. 103-465; December 8, 1994); at A.3. House 
Report No. 103-826 (II) accompanying H.R. 5110.]
    This statement describes significant administrative actions 
proposed to implement the Uruguay Round Agreements. It represents an 
authoritative expression by the Administration concerning its views 
regarding the interpretation and application of the Uruguay Round 
Agreements, both for purposes of U.S. international obligations and 
domestic law. Since this Statement was approved by the Congress at the 
time it implemented the Uruguay Round agreements, the interpretations 
of those agreements in this statement carry particular authority.
    The SPS Agreement defines appropriate level of protection as 
follows: ``Appropriate level of sanitary or phytosanitary protection-
The level of protection deemed appropriate by the Member establishing a 
sanitary or phytosanitary measure to protect human, animal or plant 
life or health within its territory. NOTE: Many Members otherwise refer 
to this concept as the `acceptable level of risk.' ''
    Article 2 sets forth a requirement that sanitary measures (not LOP) 
employed to meet an importing country's appropriate level of protection 
must be based on ``scientific principles.'' Additionally, Article 5 
requires that sanitary measures (not LOP) be based on ``an assessment, 
as appropriate to the circumstances, of the risks to human * * * 
health.''
    Neither provision limits a country's right to set its level of 
protection at any point it deems appropriate because that decision is a 
societal value judgment, not a scientific conclusion. For example, an 
importing country may decide that its tolerance for a particular 
``hazard'' in meat products is zero and put in place sanitary measures 
designed to achieve zero risk. Where science does enter this equation 
is that the hazard must actually exist and be scientifically supported. 
Specifically, an importing country could not ban a substance in meat 
under the zero risk criterion if there is no scientific evidence that 
the substance qualifies as a hazard to human health. That would be a 
``disguised restriction on international trade'' which is prohibited by 
Article 5.5 of the SPS Agreement.
    FSIS is pleased with the overall acceptance of its equivalence 
evaluation process and is committed to a continuation of the open and 
transparent manner in which we have conducted our equivalence 
activities.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, in an effort to better ensure 
that minorities, women, and persons with disabilities are aware of this 
notice, FSIS will announce and provide copies of this Federal Register 
publication in the FSIS Constituent Update. FSIS provides a weekly FSIS 
Constituent Update, which is communicated via fax to over 300

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organizations and individuals. In addition, the update is available on 
line through the FSIS web page located at http://www.fsis.usda.gov. The 
update is used to provide information regarding FSIS policies, 
procedures, regulations, Federal Register notices, FSIS public 
meetings, recalls, and any other types of information that could affect 
or would be of interest to our constituents/stakeholders. The 
constituent fax list consists of industry, trade, and farm groups, 
consumer interest groups, allied health professionals, scientific 
professionals, and other individuals that have requested to be 
included. Through these various channels, FSIS is able to provide 
information to a much broader, more diverse audience than would 
otherwise be possible. For more information or to be added to the 
constituent fax list, fax your request to the Congressional and Public 
Affairs Office, at (202) 720-5704.

    Done at Washington, DC on: December 8, 1999.
Thomas J. Billy,
Administrator.
[FR Doc. 99-32551 Filed 12-16-99; 8:45 am]
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