Draft Guidance on Equivalence Criteria for Food

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D-0202]

Draft Guidance on Equivalence Criteria for Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing for

public comment the criteria that the agency intends to use in

evaluating whether the regulatory systems used by foreign countries to

ensure the safety of foods exported to the United States for human

consumption are equivalent to the regulatory system of the United

States. Based on its evaluation, FDA will decide whether to institute

the proceedings necessary to enter into an equivalence agreement with

the foreign country.

DATES: Submit written comments by August 4, 1997.

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,

Rockville, MD 20857. Comments are to be identified with the docket

number found in brackets in the heading of this document. Received

comments are available for public examination in the Dockets Management

Branch between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Mary I. Snyder, Center for Food Safety

and Applied Nutrition (HFS-415), Food and Drug Administration, 200 C

St. SW., Washington, DC 20204, 202-418-3152.

SUPPLEMENTARY INFORMATION:

I. The SPS Agreement

Under Article 4 of the World Trade Organization (WTO) Agreement on

the Application of Sanitary and Phytosanitary Measures (SPS) (the SPS

Agreement), each member nation of the WTO, including the United States,

is obligated to accept as equivalent a food regulatory system of

another country if it provides the same level of health protection as

is provided to consumers by its own system.

Equivalent regulatory systems need not be identical. Under the

concept of equivalence, the ``sanitary or phytosanitary measures'' used

by an exporting country may differ from the measures applied

domestically by an importing country so long as these measures

``achieve the importing Member's appropriate level of sanitary or

phytosanitary protection.'' According to the SPS Agreement, ``sanitary

or phytosanitary measures'' include all relevant laws, decrees, and

regulations; as well as procedures relating to end-product criteria,

processes and production methods, testing, and inspection. Essentially,

SPS measures include virtually any measure to protect human health

arising from risks in food.

Under the SPS Agreement, the burden of demonstrating that

equivalence exists rests with the exporting country. The importing

country has the right to decide for itself whether the regulatory

system of the exporting country is equivalent to its own or is

inadequate to achieve ``the importing Member's appropriate level of

sanitary or phytosanitary protection,'' or that inadequate evidence has

been provided to demonstrate equivalence. The SPS Agreement specifies

that exporting countries allow ``reasonable access'' to the importing

country to inspect or carry out other procedures for evaluating

equivalence. If the exporting country can demonstrate equivalence, the

importing country ``shall accept'' the exporting country's system as

equivalent.

Additionally, each member country is obligated to ``enter into

consultations'' with a requesting country ``with the aim of achieving

bilateral and multilateral agreements on recognition of the equivalence

of specified sanitary or phytosanitary measures.'' Although the SPS

Agreement does not require that every finding of equivalence of a

measure or system of measures between countries should result in a

bilateral or multilateral agreement, the SPS Agreement does require

that members consult, if requested, with that potential goal.

A number of exporting nations have requested that the United States

enter into consultations with them for the purpose of developing

equivalence agreements for seafood. One reason for these requests is

that FDA regulations for seafood (part 123 (21 CFR part 123)) mandate

responsibilities for importers that are deemed to be met whenever an

equivalence agreement exists that covers the seafood products being

imported into the United States. These regulations become effective

December 18, 1997 (60 FR 65096 to 65202, December 18, 1995).

Equivalence for other types of products is being discussed with

exporting countries at their request. Similarly, the United States is

seeking equivalence determinations from certain countries to which it

exports food products.

It would be useful, therefore, for FDA to articulate how it intends

to carry out equivalence determinations. FDA has decided that the best

way to do so is by developing and publishing criteria that the agency

intends to apply in determining whether equivalence exists between the

U.S. food regulatory system and that of an international trading

partner whose regulatory system is not essentially identical to the

U.S. system.

FDA intends these criteria as guidelines that represent the

agency's current thinking on equivalence for the SPS Agreement. The

guidelines do not create or confer any rights for or on any person and

do not operate to bind FDA or the public.

II. Potential for Public Health and Other Benefits From Equivalence

FDA takes the view that equivalence in food safety measures between

the United States and its international trading partners can be

beneficial and should be fostered for its own sake. As countries

achieve equivalence with the U.S. advanced regulatory system, consumers

in this country will have greater assurance that imported foods are as

safe and wholesome as domestically produced foods.

The situation with food imports into the United States provides an

excellent example of the desirability of achieving equivalence between

the United States and its trading partners. Food is imported into the

United States from around the world and the number of formal customs

entries every year is about 1.5 million.

For the most part, FDA's inspections of food processing facilities

in other countries can occur only on a limited basis. Foreign

inspections are extremely costly and usually are not undertaken without

an invitation from the foreign country. FDA does make a consistent

effort to inspect the foreign processors of some types of products,

such as infant formula, but the number of such processors--and thus the

number of such inspections--is relatively low.

FDA's traditional surveillance system for food imports has largely

consisted of reviewing customs entries, engaging in field examinations

and collecting samples for laboratory analysis, and placing products

with a history of problems on detention without physical examination.

While FDA performs either an electronic screening or a documentary

review of virtually all customs entries with the help of automated

systems, the agency can physically examine only a very small percentage

of these entries. Huge sums of money would be needed to enable

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FDA to increase its physical examination and sampling program.

Where equivalence has been determined to exist, however, the work

of the foreign regulatory authority should serve to help ensure the

safety of imports for U.S. consumers. Since the foreign inspection

system will have been found to be equivalent to FDA's inspection

system, FDA will be able to rely on the results of the foreign

inspection system.

The possibility of equivalence agreements between and among

international trading partners, with rights and benefits that accrue to

the parties involved, provides an incentive for countries to improve

their regulatory systems and the public health of their food exports as

a means of achieving equivalence with more advanced regulatory systems.

As equivalence is achieved, and agreements are reached recognizing the

achievement of equivalence, trade is likely to flow more freely because

of the reduced need by importing countries to engage in resource-

intensive sampling and examination of products being offered for entry

from countries with equivalent systems. For the United States,

equivalence agreements will also mean that FDA will be able to target

the limited resources it has for imports toward products from countries

that have not been determined to be equivalent. Thus, FDA will be able

to use its resources more efficiently and effectively. U.S. industry

can also benefit from these agreements because in those cases where the

U.S. system is found to be equivalent to that of its trading partners,

acceptance of U.S. products by those countries is assured. The purposes

and types of equivalence agreements are described later in this notice.

Finally, where equivalence exists and is acknowledged in an

agreement, there will be no need under many circumstances for importing

nations to continue to require certificates from the competent

regulatory authority of the exporting country to accompany each

shipment. (FDA does not generally require that imported products be

accompanied by certificates; however, there is an increasing trend for

foreign countries to require such certificates.) Where there is

recognition that the exporting country's system provides an appropriate

level of sanitary or phytosanitary protection, the issuance of

certificates for specific products would represent a needless

expenditure of public health resources with no obvious advantage to

consumers or to industry. Adequate assurances may be achieved by

providing lists of food processors that are in good standing with the

regulatory authority of the exporting country or similar information.

III. Problem Solving Agreements vs. Equivalence Agreements

FDA has experience developing and entering into bilateral

agreements with trading partners for the purpose of providing assurance

that food from those countries will be safe for U.S. consumers.

However, these agreements have focused on assuring compliance with U.S.

requirements by the foreign regulatory authority for foods that present

high risks or that have had persistent compliance problems, rather than

on whether the regulatory systems were equivalent. Such agreements

involve the application of virtually identical measures by the

exporting and importing country to the subject commodity or compliance

with specific end-product criteria to address a food safety problem.

For example, FDA has several longstanding Memoranda of

Understanding (MOU's) with nations that export raw molluscan shellfish

to the United States. Under these MOU's, each country has agreed to

abide by the same detailed standards for regulating the growing and

harvesting of raw molluscan shellfish that U.S. States have agreed to

follow. These countries have entered into such MOU's in order to have

access to the U.S. market. Under a Federal-State cooperative

arrangement for raw molluscan shellfish, the National Shellfish

Sanitation Program (NSSP), FDA lists the processors who have been found

to be in compliance by States and countries that have a shellfish

program that meets the NSSP standards. States decide what shipments of

shellfish they will act against based on whether the processor of the

shellfish is included on FDA's list. Recently, some of the countries

with MOU's have expressed an interest in converting their MOU's from

compliance-type agreements to equivalence agreements to permit some

variations from the details of the U.S. program.

FDA has also periodically entered into MOU's or other less formal

agreements with countries that have a significant volume of trade with

the United States in certain products but have developed chronic,

safety-related problems with these products. In these cases, the

agreement is intended to correct these problems. Examples include

agreements aimed at the control of excessive levels of lead and cadmium

leaching from ceramicware for food use, the control of pesticide

residues in certain types of fruits, and the control of pathogenic

microorganisms in soft ripened cheese and certain dried milk products.

Traditionally, FDA has assigned a higher priority to agreements

targeted toward solving specific problems than it has to recognizing

foreign food control systems as providing the same level of protection

as those in the United States. This policy of favoring problem solving

agreements over others is set forth in FDA's Compliance Policy Guide

(CPG) section 100.900, Attachment A, which contains the agency's

criteria for how it will prioritize international MOU's.

In December 1995, FDA entered into a compliance-based Cooperative

Arrangement with the New Zealand Ministries of Agriculture and Health

for the purpose of ensuring the safety of fish and fishery products

traded between the two countries. Significantly, it was not a problem

solving agreement. Rather, it recognized that the strong regulatory

systems in the United States and New Zealand enhanced the likelihood

that products from each country would comply with the regulatory

requirements of the other. The participants agreed to take this

recognition into account in determining the frequency of border checks

for fish and fishery products traded between the United States and New

Zealand. While this arrangement was not intended to be an equivalence

agreement, it does reflect the principle that the employment of

comparable, high-standard regulatory systems by international trading

partners can enable each nation to enhance the public health protection

of its consumers and shift inspectional resources to other, more risky,

products.

Although FDA continues to see merit in narrowly focused, problem

solving MOU's, the agency also sees value in pursuing equivalence

agreements. Therefore, FDA is considering revising CPG section 100.900,

Attachment A, ``Food and Drug Administration Criteria for Memoranda of

Understanding'' to add recognition of equivalence as a basis for

entering into agreements with foreign governments. Should the agency

choose to do so, it will issue a separate notice to that effect, with

an opportunity for public comment.

IV. Possible Forms that Equivalence Agreements Could Take

There are several possible forms that equivalence agreements could

take, depending upon the relevant circumstances.

[[Page 30595]]

A. ``One-Way'' Agreements vs. ``Two-Way'' Agreements

Equivalence agreements can involve simultaneous determinations by

two countries that their regulatory systems are equivalent to one

another (``two-way'' agreements). This is the favored type of agreement

from FDA's standpoint. A determination that a trading partner's

regulatory system is equivalent to the U.S. system means that imports

from that country have been produced under circumstances that provide

U.S. consumers with the same level of protection as domestic products.

A determination by the trading partner that the U.S. system is

equivalent to its system helps ensure that exports from the United

States will flow freely to the country in question. It will be FDA's

policy to negotiate ``two-way'' agreements whenever practicable.

FDA may, however, enter into ``one-way'' agreements as appropriate.

A ``one-way'' agreement would involve a finding by only one country

that the regulatory system of a foreign government was equivalent to

its own. A ``one-way'' agreement would be appropriate where there

existed, essentially, a one way flow of trade in the commodities that

were subject to the agreement. A ``one-way'' agreement might also be

entered into as a temporary measure when one country was prepared to

find a trading partner's system equivalent to its own, but the other

country was not yet able to make a similar determination. Instead of

delaying the agreement until a ``two-way'' agreement could be

completed, the two countries could decide to agree in ``one-way''

stages.

B. All Products or Processors vs. Some Products or Processors

FDA may negotiate equivalence agreements that encompass some or all

foods being exported to the United States from a foreign country, but

will generally focus on agreements that cover one or two food

categories with a high trade volume. As indicated earlier, FDA expects

that many of the initial food-related equivalence evaluations will

involve fish and fishery products. (The U.S. imports about 55 percent

of the seafood it consumes.) Such evaluations will not consider whether

the regulatory system of the foreign country is equivalent for other

products.

Even within the category of products being considered for an

agreement (e.g., fish and fishery products), equivalence may exist for

some of those products but not for others. In those cases, FDA would

enter into equivalence agreements that cover only those products. An

agreement of this nature would not preclude trade in the remaining

products, but such trade would be outside the scope of the agreement

and thus likely subject to more intense scrutiny at ports of entry. The

two most predictable situations in which a limited equivalence

determination is likely are: (1) Where the regulatory system of the

foreign country is designed to achieve, or is only capable of

achieving, equivalence for some products but not for others; and (2)

where U.S. standards for certain products are more stringent than those

of the foreign country so as to rule out equivalence for those

products.

The same principle should hold true for processors as well as for

products. Some countries have a mix of modern, relatively advanced

processing operations and other operations that are much less so, and a

regulatory structure capable of achieving equivalence only with regard

to the advanced processors. Other countries differentiate between food

processors that are licensed to export, and processors that are not so

licensed. In any case, it is important to remember that the agreement

is between the United States and the government of the foreign country

and not with individual processors or other private entities.

C. ``Piggy Back'' (``Triangular'') Agreements

FDA is interested in exploring the concept of ``piggy back''

equivalence agreements (also referred to as ``triangular'' agreements).

Under this concept, two countries that have established an equivalence

agreement would agree that additional agreements between either of the

countries and a third country would be recognized by both countries.

Thus, if FDA had both an equivalence agreement with Country ``A'' and a

``piggy back'' arrangement with Country ``A,'' and Country ``A'' had an

equivalence agreement with Country ``B,'' FDA would recognize that

Country ``B'' is equivalent to the United States in part on the basis

of Country ``A's'' finding.

For such a system to work, a basis must exist for FDA to have found

on its own that Country ``B's'' system was equivalent to the U.S.

system. Among other things, FDA would have to have a high level of

confidence in Country ``A's'' ability to make an equivalence

determination, based on a detailed knowledge of Country ``A's''

verification and audit capabilities. This knowledge and confidence

could be acquired through a mutual undertaking of audit

responsibilities and a sharing of the results of audits. There would

always have to be some form of confirmation by FDA that equivalence

exists along with an adequate administrative record to support a

finding of equivalence.

If such an arrangement could be established, it would provide

enhanced incentives for countries to achieve equivalence with the most

advanced regulatory systems because a finding of equivalence with one

advanced country could hasten equivalence with other advanced

countries. Obviously, a ``piggy back'' system would also permit a

significant public health gains and resource savings for countries in

negotiating equivalence agreements.

Some experience with equivalence agreements will be needed before

FDA could enter into ``piggy back'' agreements. The agency invites

public comment on this issue.

V. The Equivalence Agreement Process

FDA contemplates a process that will involve a paper review, an on-

site verification review, and public notice and comment in making a

determination that a foreign country's regulatory system is equivalent.

The paper review would compare the U.S. system of laws, regulations,

standards, regulatory practices and procedures, and all other relevant

matters with those of the foreign country based on information provided

by the foreign government. The review, which would be carried out by

FDA in the United States, is expected to consist in part of a side-by-

side comparison of the elements of the U.S. system and the elements of

the foreign system to determine what similarities and differences exist

between the two systems and to provide the basis for an assessment of

the significance of the differences. This paper review will cover both

the foreign country's requirements for industry and its inspection

system.

If the paper review shows that the two systems may be equivalent,

the results of this paper review will form the basis for one or more

on-site visits to verify the results of the paper review and to obtain

whatever additional information may be necessary. The purpose of an on-

site visit would not be to inspect the processors in that country,

although it is expected to include visits to some processors, but

rather to verify that the foreign regulatory system, including its

plant inspection system, is functioning as indicated in the paper

review. The on-site visit is an audit of the system, not an audit of

foreign processors.

FDA would then make a preliminary determination of whether

equivalence exists and would publish this preliminary determination in

a notice

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for public comment in the Federal Register. FDA is under an obligation

to do so in accordance with Pub. L. 103-465, the implementing

legislation for U.S. participation in WTO agreements. This law states:

If the Commissioner [of Food and Drugs] proposes to issue a

determination of the equivalency of a sanitary or phytosanitary

measure of a foreign country to a sanitary or phytosanitary measure

of the Food and Drug Administration that is not required to be

promulgated as a rule under the Federal Food, Drug, and Cosmetic Act

or other statute administered by the Food and Drug Administration,

the Commissioner shall publish a notice in the Federal Register that

identifies the basis for the determination that the measure provides

at least the same level of sanitary or phytosanitary protection as

the comparable Federal sanitary or phytosanitary measure. The

Commissioner shall provide opportunity for interested persons to

comment on the notice. The Commissioner shall not issue a final

determination on the issue of equivalency without taking into

account the comments received.

FDA is committed to this public process and intends that Federal

Register notices published in accordance with this requirement will

provide the public with a full explanation of why FDA has tentatively

concluded that equivalence exists in a given situation. This

explanation should cover, at a minimum, both the results of the paper

review and a summary of the on-site visit. The final determination will

take into account the comments received.

VI. Fundamental Principles

In determining whether equivalence exists and in entering into any

agreements on equivalence, FDA intends to be guided by several basic

principles. These include the following:

A. Transparency of Process and Reasoning

As indicated above, the factual basis for a determination of

equivalence must be publicly available and clearly understood. To the

extent that FDA is looking to foreign regulatory authorities to help to

ensure the safety of food for U.S. consumers, the public has a right to

review and understand the basis for FDA's action. Consumer confidence

in food depends in large measure on the confidence it has in the

regulatory safeguards that exist for that food.

B. No Loosening of Standards

U.S. standards will not be relaxed to facilitate a finding of

equivalence. For example, products that contain unapproved additives or

that contain poisonous or deleterious substances in amounts sufficient

to render them adulterated under Federal law will be adulterated even

if an equivalence agreement exists. Unless the foreign country can

provide reasonable assurance that its products will meet these

standards (i.e., will not be adulterated), equivalence will not be

possible, at least for those products.

C. Fundamental Fairness and Consistency

Processing requirements that are essential for the production of

safe food are germane to both domestic products and products that are

imported into the United States, although, as discussed later,

equivalence may permit appropriate latitude regarding the details.

D. Adequate Verification

If FDA has entered into an equivalence agreement, the agency must

engage in adequate ongoing verification, including appropriate checking

of imports, to ensure that equivalence continues to exist. FDA cannot

rely solely on foreign regulatory authorities to ensure that

equivalence is maintained. Presumably this principle will hold true for

the foreign regulatory authority as well.

VII. What Is Equivalence?

A. United States Levels of Protection

As stated in section I of this document, according to the SPS

Agreement, equivalence is achieved when an exporting country's measures

meet an importing country's ``appropriate level of sanitary or

phytosanitary protection,'' even though those measures are not the same

as those of the importing country. A level of protection can be viewed

in terms of the limitation on risk that a society requires relative to

a particular hazard or hazards.

In the United States, the appropriate levels of sanitary or

phytosanitary protection for the foods regulated by FDA are governed by

the very broad, qualitative provisions of the Federal Food, Drug, and

Cosmetic Act (the act), and the regulations issued under it, which

state the circumstances in which a product will be deemed to present an

unacceptable risk to U.S. consumers, i.e., will be deemed to be

``adulterated.'' For example, a food additive will be deemed to

adulterate a food unless it is approved for use in that food (section

402(a)(2)(C) of the act (21 U.S.C. 342(a)(2)(c))) based on a showing

that there is a ``reasonable certainty'' that no harm will result from

its becoming a component of the food (section 409(a) of the act (21

U.S.C. 348(a)) and Sec. 170.3(i) (21 CFR 170.3(i))). Food is also

adulterated if it is contaminated with an added poisonous or

deleterious substance ``which may render it injurious to health''

(section 402(a)(1) of the act). The act has several other adulteration

provisions, including provisions that apply in specific situations,

such as in the preparation of infant formula and the use of color

additives. Sometimes, as with food additives, the act (a food additive

must be ``safe'' under section 409) and the regulations (definition of

``safe'' in Sec. 170.3(i)) must be read together.

These governing provisions express levels of protection in terms of

overarching public health standards. However, in considering a

particular risk or types of risks, these broadly stated standards need

further elaboration to provide understanding of how they apply. For

example, a determination of whether there is a reasonable certainty of

no harm from the use of a food additive is dependant on an operational

definition of that standard that facilitates its application to a

specific food use of a substance. Operational definitions can be found

in various places, ranging from the explanatory materials that are

developed in rulemaking (i.e., preambles) to the codified text of a

rule (see Secs. 170.3, 170.20, and 170.22 (21 CFR 170.20 and 170.22)),

to guidance materials, and even to judicial decisions.

For example, the operational definition for ``reasonable certainty

of no harm'' from the use of a food additive involves determining the

exposure to that additive that will not produce adverse effects in

humans. This level is obtained through the application of an

appropriate, scientifically based, safety factor (e.g., 100-fold, as

provided in Sec. 170.22) to the lowest no-effect level observed in a

toxicological study in animals. As can be seen from this example, the

level of protection afforded by the law of the United States is the

protection that emerges when a broad, statutory public health standard

is applied, through an operational definition, to a particular risk.

Operational definitions serve as a bridge between the underlying

standard and the measures that are developed to achieve the desired

level of protection. In the above example, the primary measure that the

United States uses to achieve its level of protection for food

additives is an approved level of the additive that is permissible in a

particular food.

Quantification is not the only way to provide a level of

protection, and in many situations quantification is not practical. An

excellent example of a

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level of protection that is qualitative rather than quantitative is

that provided by the food safety processing system known as Hazard

Analysis Critical Control Point (HACCP), which FDA has mandated for the

processing of seafood. The statutory standard from which this

protection derives states that food should not be prepared, packed, or

held under conditions ``whereby it may have been rendered injurious to

health'' (section 402(a)(4) of the act). Concerns about the conditions

under which seafood is processed led FDA to conclude that to give this

standard meaning in the circumstances under which seafood is processed,

it would be necessary to impose a prevention-oriented system of food

safety controls which would operate to define the statutory standard by

ensuring that hazards are identified in advance and then prevented or

reduced to an acceptable level through the application of several

specific principles (see the preamble to FDA's seafood regulations (60

FR 65096). The primary measure by which this level of protection is

achieved is a regulation that requires that food processors establish

and operate under such a system (21 CFR part 123).

B. Measures for Achieving U.S. Levels of Protection

As the previous examples demonstrate, the United States provides

protections both through outcome (whether the food contains an

unapproved substance or an undesirable substance in sufficient quantity

to adulterate it) and method of production (i.e., whether the

conditions under which a food is prepared, packed, or held are

conducive to producing a safe product). It is important to recognize

that food is adulterated under U.S. law unless there is adherence to

all applicable protections. A food might be free of contaminants, and

thus be consistent with the protections extended by law in that

respect, but still be adulterated under section 402(A)(4) of the act

because it was processed under insanitary conditions whereby it may

have become contaminated.

Thus, the U.S. regulatory system for food addresses both outcome

and processing. As a practical matter, therefore, FDA would expect that

another country's SPS measures must also address both outcome and

processing if those measures are to provide assurance that food offered

for export to the United States meets the U.S. level of protection.

1. Outcome

In establishing and enforcing tolerances, or maximum residue levels

(MRL's), for food contaminants or residues of pesticides or veterinary

drugs in foods as risk management measures, the United States ensures

that its levels of protection are met. MRL's are based on assessments

of the risks to human health and specifically to the health of U.S.

consumers. These assessments take into account factors such as

toxicity, expected residue levels based on labeled use of the product,

and expected dietary exposures based on the U.S. diet.

As these factors suggest, the U.S. MRL's are based in part on

domestic circumstances. It is not clear how a less stringent MRL could,

alone, address these factors in a way that achieves the same level of

protection for U.S. consumers as the U.S. MRL. Further, food containing

contaminants or residues in excess of U.S. MRL's are deemed to be

adulterated under U.S. law. Therefore, as a practical matter, as part

of evaluating whether a foreign regulatory system can be judged

equivalent, the agency would expect adequate assurances that U.S. MRL's

will not be exceeded in those foods being exported to the United

States.

It may be possible for a country with a less stringent MRL, or no

MRL, to achieve equivalence, however, if it can demonstrate that the

products that it exports to the U.S. will not contain contaminants in

excess of the U.S. MRL. If, for example, the United States has

established level ``L'' for a particular contaminant in a food, an

exporting country could demonstrate that the food that it exports to

the United States will not contain the contaminant because conditions

do not exist there whereby the food would be exposed to the contaminant

or contain levels in excess of the U.S. MRL.

An exporting country could also seek to present scientific evidence

to demonstrate that the United States could meet its own level of

protection with a less stringent MRL. While importing countries may

occasionally revise older MRL's on the basis of such demonstrations,

FDA expects that these revisions will occur only in limited situations

if the importing country already bases its SPS measures on science, as

does the United States.

In addition to tolerances, or MRL's, which are considered binding

under U.S. law, FDA has provided ``action levels'' for contaminants as

nonbinding guidance for FDA, industry, and the public about the level

at which the contaminants in question may pose a health risk, based on

available science. In providing nonbinding regulatory guidance, FDA may

choose to take regulatory action when it finds that an action level has

been exceeded or decide to exercise discretion based on the

circumstances and risks posed by the particular case. Nevertheless, the

manner in which the action level is applied to domestic products and to

imports should be the same, and action levels should be taken into

account when determining equivalence.

2. Conditions of Production

How a product is prepared, packed, or held can be of great

importance to the safety of the product. As with the issuance of

tolerances or MRL's, FDA periodically issues regulations on how certain

foods must be processed to ensure that the foods are safe, and that

U.S. levels of protection are met. The agency engages in inspections of

processing establishments to determine whether these processing

requirements are being carried out.

Attention to processing helps ensure that food is safe by

preventing potential food safety problems and by ensuring that

processors are aware of problems that may develop, and that they

address those problems when they do occur. Sanitary and phytosanitary

measures are credible to the extent that they decrease the likelihood

that problems will occur, or increase the likelihood that problems will

be discovered and corrected quickly, even when the regulatory inspector

is not present.

End-product testing, which measures outcome, cannot generally be

relied upon exclusively to provide an adequate level of protection

because it only tests for a specific risk or group of risks on a

particular day. The results of end-product sampling may or may not be

representative of the actual, continuing risk, depending upon product

uniformity, the amount of sampling, and other factors. Processing

controls coupled with adequate verification by a regulatory authority

provide an essential assurance that food will not present unacceptable

risks. Processing controls can assure that the level of protection is

met in many circumstances where end-product testing alone realistically

cannot.

FDA, therefore, has issued several regulations that focus on how

food is to be processed. The overall purpose of these regulations is to

require that processing methods and equipment be appropriate to control

potential risks. The regulations take into account available scientific

evidence on food safety hazards and controls, relevant processes and

production methods, and relevant economic factors, including costs and

benefits. One of these regulations establishes basic sanitation

principles and good manufacturing practices for all foods (``Current

Good

[[Page 30598]]

Manufacturing Practice in Manufacturing, Packing, or Holding Food,''

(part 110 (21 CFR part 110)). Others require a specific processing

regimen to control a particular problem or problems in certain types of

foods. These regulations are key elements in FDA's regulatory system.

For purposes of equivalence, therefore, FDA will be looking for SPS

measures established by an exporting country that fully address the

objectives and purposes of applicable FDA regulations. FDA's

examination may occur on a provision-by-provision basis, or on some

other basis, as the agency deems necessary. To the extent possible, for

example, differences in requirements affecting the actual physical

dimensions or components of equipment (e.g., hand washing equipment for

employees) will generally be less important than whether the broader

public health purposes or objectives to which the equipment relates

(i.e., personnel hygiene) are being adequately addressed. In any event,

FDA will be prepared to articulate the objectives or purposes of its

regulatory provisions during consultations on equivalence with foreign

governments.

3. Labeling and Other Special Considerations

FDA notes that the SPS Agreement includes labeling within its

definition of sanitary or phytosanitary measures. Not all labeling

falls within this definition, however. Regarding labeling that does

meet the definition, it is not clear to FDA how labeling that fails to

meet U.S. requirements could be equivalent to these requirements.

Therefore, the agency is not offering criteria at this time on how such

labeling could be found to be equivalent and invites comment on whether

differing SPS labeling requirements can be equivalent, and how

determinations of equivalence should be made.

Similar difficulties may be presented by particular types of foods

(e.g., infant formula and medical foods), which are subject to special

statutory requirements (see section 412 of the act (21 U.S.C. 350a)).

Therefore, FDA also requests comment about how it should handle

equivalence determinations for those types of products.

4. Elements of the U.S. Regulatory System

As indicated previously, SPS measures include laws, decrees,

regulations, and related matters. Clearly, the operations and functions

of a country's regulatory system, which implements laws and issues

decrees and regulations, constitute SPS measures. It is thus necessary

to identify the elements of the U.S. regulatory system and the purposes

that these elements serve in order that foreign regulatory systems can

be compared against these measures and purposes.

For foods regulated by FDA, there are essentially two layers of

regulatory authority: Federal or national authority, represented

primarily by FDA, with regulatory jurisdiction over food in interstate

commerce, as broadly defined in relevant case law, and individual State

and local regulatory systems, with regulatory jurisdiction over food

within their boundaries. The State systems are germane for purposes of

``two way'' equivalence primarily because States engage in regulatory

inspections of food processors in addition to those conducted by FDA.

Inspections, as discussed below, are a key element of the U.S.

regulatory system.

The elements of the U.S. regulatory system may be thought of as

falling into two broad categories. The first is infrastructure, which

includes applicable law and the government bodies charged with

implementing the law. The second category is implementation, or

performance, which relates to how the infrastructure actually operates

to prevent and control food-related risks. It is worth pointing out

that, under the U.S. system, private food producers are responsible for

producing safe food, while government is essentially responsible for

verifying that producers are meeting their obligations and for taking

remedial action when they fail to do so.

a. Infrastructure.

1. Law. The United States has national law that includes the

following purposes:

To prohibit the introduction of adulterated or misbranded

food into commerce;

To broadly establish what constitutes adulteration and

misbranding;

To authorize national regulatory agencies with the power

to establish standards for foods (including how it is prepared, packed,

and held), to conduct mandatory inspections of food processors, to

issue processing requirements for food, and to take enforcement action

to prevent adulterated or misbranded food from entering commerce and to

remove it from any stage of interstate commerce if found.

In order for equivalence to be achieved, a foreign country needs to

have laws applicable to food to be exported to the United States that

achieve essentially the same objectives and will meet U.S. levels of

protection. In addition, as discussed below, the foreign country must

have the authority to implement the law in an appropriate way and must

be, in fact, doing so.

2. Regulatory authority. The United States has national regulatory

agencies that implement Federal food safety law applicable to all food

in interstate commerce in the United States, including food to be

exported. Essential characteristics of these agencies include, but are

not limited to, the following:

A regulatory infrastructure capable of, and engaged in,

identifying existing and potential public health problems associated

with food and capable of establishing appropriate regulatory policy

with regard to such problems, including, but not limited to, the

establishment of scientifically-based regulatory standards, processing

requirements, and guidelines. This capability includes the ability,

either within the agency or through contact with other agencies, to

determine the causes of illness from foods that may be consumed

domestically or shipped for export.

An inspection infrastructure capable of, through

appropriate training and experience, and engaged in conducting

mandatory inspections of commercial entities that prepare, pack, and

handle food to determine whether these entities are meeting their

responsibility to produce food that is not adulterated. Inspections

should include both observation and the taking of product samples for

laboratory or organoleptic examination.

A laboratory infrastructure that is capable of, and

engaged in, analyzing samples to determine the presence and quantity of

adulterants that are reasonably likely to affect food, including but

not limited to pathogens, chemicals, toxins, and parasites. The

methodologies used should have, in most cases, been approved or

validated by recognized entities that are competent to evaluate such

methods. The competency of the laboratories to use these methods has

been appropriately evaluated and maintained through extensive quality

assurance programs.

An enforcement infrastructure that is capable of, and

engaged in, reviewing the findings from inspections and making rapid

determinations as to whether regulatory action is necessary to resolve

existing or potential public health problems. Where regulatory action

is necessary, the enforcement infrastructure has available to it a

range of actions designed to remove violative product from distribution

and prevent a recurrence of the problem.

An internal monitoring infrastructure to preserve the

integrity and credibility of the agency's food

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protection system. The infrastructure must be able to issue and enforce

rules and procedures to promote ethical behavior, and to protect

against conflict of interest, among its employees.

In order to be equivalent to the United States, a foreign country

should have a regulatory infrastructure with jurisdiction over food to

be exported to the United States that, at a minimum, possesses these

characteristics. It is not necessary that these characteristics reside

solely within a single government agency. They may be performed by

multiple agencies at a national level or, under a Federal-type system,

by a combination of national and local government agencies, as long as

there is adequate assurance that the functions are being carried out

adequately and in a reasonably consistent and coordinated manner.

Also, FDA does not rule out the possibility that nongovernment

entities might be able to perform some regulatory functions under

strictly controlled circumstances. When any function is performed by a

nongovernment entity, such as a private inspection organization, there

must be sufficient government oversight of the private organization to

ensure that the relevant regulatory functions are being carried out

adequately and in a manner that preserves the integrity and credibility

of the functions. Ultimate regulatory responsibility must continue to

rest with the government. In determining whether equivalence exists

under such circumstances, FDA would expect the foreign government to be

engaged in rigorous oversight over the nongovernment entity.

b. Implementation.

Equivalent implementation is achieved when the foreign regulatory

infrastructure is carrying out its functions in a manner that provides

a reasonable assurance that the products being offered for import into

the United States meet our country's levels of protection and thus are

not adulterated under U.S. law. While FDA will examine each function

separately, the decision as to whether equivalence exists will be based

on a consideration of whether the foreign country's system as a whole

in some way provides the assurances that are provided by the U.S.

system. As indicated previously, the whole system must be able to

provide assurances beyond those that would be provided solely through

end-product testing.

This examination may also take into account relevant conditions in

the foreign country. For example, in considering whether inspections

occur with sufficient frequency, FDA may consider sanitary and other

conditions in that country, and particularly in processing plants, that

bear on how much on-site presence and intervention by regulatory

authorities is necessary to provide adequate assurance that adulterated

products are not being exported. Furthermore, the degree to which

industry uses appropriate processing controls can influence the methods

and procedures by which government verifies compliance.

When considering the performance of the country's regulatory

infrastructure, FDA intends to take into account experience already

acquired with that country, including historical data from FDA

monitoring of its products that are exported to the United States.

APPENDIX

Equivalence for Seafood

Because FDA has already received requests for consultations on

seafood from a number of countries, the agency is including in this

Appendix specific guidance on determining equivalence with its seafood

HACCP regulations and with other features of its regulatory program for

seafood. FDA may choose to issue specific additional guidance for other

types of food at a later date.

A. HACCP and the Prerequisites

FDA's seafood HACCP regulations declare that fish and fishery

products in interstate commerce are adulterated if they are not

processed in accordance with the principles of HACCP and prerequisite

requirements for sanitation provided for therein (Sec. 123.6(g)),

regardless of whether the products may be otherwise adulterated. As

with other regulations, the FDA seafood HACCP regulations have the

force and effect of law. The regulations apply to imports into the

United States as well as to products produced domestically.

In the absence of a determination of equivalence, imports must be

processed in compliance with the regulations. In any consultations

relating to equivalence, an exporting nation will be given the

opportunity to demonstrate that its own measures for the seafood that

is being exported from it to the United States are adequate to ensure

that the objectives and purposes of each provision of the U.S.

regulations will be met.

The seafood HACCP regulations require that fish and fishery

products be processed under a system of preventive controls to ensure

the safety of the food for human consumption. As part of this system,

commercial processors must demonstrate the following: (1) A knowledge

of safety hazards to which their products are subject; and (2) the

ability to identify and apply controls that eliminate or minimize the

likelihood of the occurrence of those hazards in the products. HACCP is

essentially the opposite of end-product testing, which attempts to

detect problems after they have occurred. As a scientifically-based

processing control system, HACCP is able to achieve the level of

protection deemed appropriate for the risks posed by seafood. End-

product testing or other types of process controls that do not involve

systematic, daily monitoring in conjunction with hazard analysis,

cannot achieve this level of protection.

The preventive controls of HACCP are applied through the

application of seven internationally recognized principles, all of

which are required of seafood processors in the FDA regulations. These

are:

(1) Conduct a hazard analysis.

(2) Identify the critical control points (CCP) in the process. A

CCP is a point, step, or procedure in a food process at which control

can be applied, and a food safety hazard can, as a result, be

prevented, eliminated, or reduced to acceptable levels.

(3) Establish critical limits for preventive measures associated

with each identified CCP. A critical limit is the maximum or minimum

value to which a physical, biological, or chemical parameter must be

controlled at a CCP to prevent, eliminate, or reduce to an acceptable

level the occurrence of the identified food safety hazard.

(4) Establish CCP monitoring requirements.

(5) Establish corrective action to be taken when monitoring

indicates that there is a deviation from an established critical limit.

(6) Establish effective recordkeeping procedures that document the

HACCP system.

(7) Establish procedures for verification that the HACCP system is

working correctly.

These principles have been recognized in a Codex Alimentarious Code

of Practice for Food Hygiene guide. Countries seeking a determination

of equivalence regarding seafood should have measures involving a

system of preventive controls that honors these seven principles. There

is latitude regarding how countries mandate and operate such a system.

For example, FDA regulations contemplate a mix of processor and

government activities to fulfill the seventh principle, verification.

Hypothetically, however, a country electing to have its regulatory

agency conduct all verification activities would be given the

opportunity to

[[Page 30600]]

demonstrate that its verification procedures meet the purposes and

objectives of the U.S. requirement. It is worth noting that the

purposes and objectives of each provision of the seafood HACCP

regulations are addressed in the preambles to the regulations when

issued as a proposal (59 FR 4142, January 28, 1994) and as a final rule

(December 18, 1995).

FDA's seafood HACCP requirements do not replace or supersede the

Good Manufacturing Practices regulations for all foods in part 110 (see

section VII.B.2 of this document). These provisions provide basic good

manufacturing practices for all foods. Countries seeking a

determination of equivalence must always demonstrate SPS measures that

meet the objectives and purposes of part 110, regardless of the types

of food that are to be the subject of the equivalence determination.

In addition to the seven principles cited above, FDA's seafood

HACCP regulations require processors to engage in a sanitation program

as a prerequisite to HACCP (Sec. 123.11). The importance of good

sanitation as a prerequisite to HACCP is internationally recognized, as

exemplified by the discussions on this subject at the most recent

meeting of the Codex Alimentarious Committee on Fish and Fishery

Products. The FDA prerequisite program requires processors to monitor

and keep records of how, on a daily basis, they are meeting the

conditions and practices specified in part 110 relating to eight

fundamental areas of sanitation. Countries seeking equivalence should

have in place measures that meet the purposes and objectives of the

U.S. prerequisite requirements for sanitation.

B. FDA's Seafood HACCP Guidelines

FDA's seafood HACCP regulations provide the basic ground rules and

principles for establishing HACCP systems. For example, processors must

conduct a hazard analysis to determine what hazards must be controlled

through the seven principles of HACCP. The regulations themselves

contain little detailed guidance, however, regarding what the result of

that hazard analysis should be in a given situation.

It would not be sufficient for a seafood processor to implement a

HACCP system that failed to properly identify all specific hazards that

should be identified during the hazard analysis process or that failed

to establish appropriate controls for those hazards. Therefore, to

provide guidance on what FDA would consider adequate in implementing

the regulations, FDA has issued guidelines entitled the ``Fish and

Fishery Products Hazards and Controls Guide.''

A country seeking a determination of equivalence for seafood should

be able to demonstrate that hazards identified by its system, and the

controls applied to those hazards, are appropriate to the purposes and

objectives of the seven principles of HACCP. When making the

determination for seafood, FDA will use the ``Fish and Fishery Products

Hazards and Controls Guide'' in evaluating the exporting country's

measures relating to the identification of hazards and the

implementation of controls for those hazards.

As with a domestic processor, the exporting country has the

opportunity to demonstrate that hazards are being adequately addressed

through controls other than those described in the guidelines.

Moreover, during consultations with that country, FDA would be willing

to consider arguments that it is mistaken in its judgment regarding

hazards and controls (just as FDA is willing to listen to arguments of

this nature from domestic processors). In any event, there must

ultimately be agreement between the two countries on the outcome of

hazard analysis as well as on appropriateness of the other elements of

the program (e.g., the adequacy of controls for the identified

hazards).

At the outset, FDA plans to conduct its reviews on a product-by-

product basis, until such time as the agency has sufficient confidence

that it is no longer necessary to demonstrate adequate hazard analysis

and controls for each product to be exported from a particular country.

C. Raw Molluscan Shellfish

The safety of molluscan shellfish for human consumption raw or

partially cooked involves special considerations that must be taken

into account when determining equivalence. Because they are sedentary,

filter-feeding animals, molluscan shellfish can accumulate pathogens

and other types of contaminants that are harmful to humans. For

example, the positive relationship between harvesting areas

contaminated by sewage pollution and shellfish-borne enteric disease is

well established. Consequently, the condition of the water from which

they are harvested is critical to the safety of molluscan shellfish,

especially those that are intended to be consumed raw or partially

cooked.

The U.S. program to ensure the safety of raw molluscan shellfish

centers around a classification system for opening and closing

molluscan shellfish harvesting waters. This aspect of the program is

run by the governments of U.S. States that possess shellfish harvesting

waters. FDA audits and evaluates these State programs. The procedures

and standards for classifying waters, and for conducting other aspects

of the program, are in a document known as the Manual of Operations of

the National Shellfish Sanitation Program. From FDA's perspective, the

Manual of Operations has the status of a guideline. Each State in the

program, however, has agreed to strictly adhere to it. Moreover, each

State in the program has agreed to reject shellfish that have not been

grown, harvested, or otherwise processed in accordance with the Manual

of Operations.

Several countries have entered into MOU's with FDA for the export

of raw molluscan shellfish to the United States. (See FDA,

International Cooperative Agreements (November 1996); available from

National Technical Information Service.) Under these MOU's, the

exporting countries have agreed to comply with the Manual of

Operations, as if each were a U.S. State. Some of these countries have

expressed an interest in renegotiating these agreements as equivalence

agreements rather than compliance agreements.

The Manual of Operations is comprehensive and highly detailed.

Where differences exist between an exporting country's program and

details in the Manual of Operations, judgments must be made about the

significance of the differences. Equivalence determinations should

focus on matters of significance. A country seeking a determination of

equivalence with the United States for raw molluscan shellfish needs to

demonstrate that its program meets the purposes and objectives of the

Manual of Operations wherever a significant difference exists between

its program and the provisions of the Manual.

Dated: May 27, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97-14600 Filed 6-3-97; 8:45 am]

BILLING CODE 4160-01-F