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

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.

-----------------------------------------------------------------------

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

[email protected].

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establishment of the World Trade Organization (WTO), which superseded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

[[Page 70693]]

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]

BILLING CODE 3460-DM-P