Federal Register: June 4, 1997 (Volume 62, Number 107)
Notices
Page 30593-30600
From the Federal Register Online via GPO Access wais.access.gpo.gov
DOCID:fr04jn97-72
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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Draft Guidance on Equivalence Criteria for Food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.
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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
Page 30597
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
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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
Page 30599
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
